Headband tube for patient interface

Abstract

A patient interface for treating sleep disorder breathing includes a fabric tube that also provides support for a seal-forming structure. The fabric tube includes an inner layer and an outer layer connected along a seam to form an air chamber or passage. The fabric tube may be pre-shaped such that the fabric tube resiliently returns to a predetermined shape prior to introduction of pressurized air.

Description

[0001] This application is a divisional application of patent application No. 201980054652.4, filed on June 25, 2019, entitled "Headband Tube for Patient Interface".

[0002] CROSS-REFERENCE TO RELATED APPLICATIONS

[0003] This application claims the benefits of U.S. Provisional Application No. 62 / 821,878, filed March 21, 2019, and U.S. Provisional Application No. 62 / 689,968, filed June 26, 2018, and also claims the benefits of Australian Provisional Application No. AU 2019901040, filed March 28, 2019, and AU 2019901459, filed April 30, 2019, each of which is incorporated herein by reference in its entirety. Background Art 2.1 Technical Field

[0004] This technology relates to one or more of the following: screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses.

[0005] Some forms of this technology involve patient interfaces for treating respiratory conditions, preventing and improving respiratory-related illnesses.

[0006] 2.2 Description of relevant technologies

[0007] 2.2.1 The human respiratory system and its disorders

[0008] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0009] The airways consist of a series of branching tracheae, 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 inhaled air and expelling carbon dioxide in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branches of the airways lead 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, by John B. West, Lippincott Williams & Wilkins, 2012.

[0010] There are a range of breathing disorders. Some disorders can be characterized by specific events, such as respiratory arrest, insufficiency, and hyperventilation.

[0011] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disease.

[0012] 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. This condition causes affected patients 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 4,944,310 (Sullivan).

[0013] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder 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 6,532,959 (Berthon-Jones).

[0014] Respiratory failure is a broad term encompassing respiratory disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure may include some or all of the following disorders.

[0015] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0016] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0017] Chronic obstructive pulmonary disease (COPD) includes 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.

[0018] Neuromuscular disease (NMD) is a broad term encompassing many diseases and disorders 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 walking ability, 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 lasting more than several months and leading to death within a few years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD)); (ii) variable or slowly progressive diseases: characterized by worsening muscle damage lasting more than several years and only slightly shortening life expectancy (e.g., limb-girdle muscular dystrophy, facial-shoulder-arm muscular dystrophy, and myotonic dystrophy). Symptoms of respiratory failure in NMD include: progressive general weakness, difficulty swallowing, shortness of breath during exercise and at rest, fatigue, drowsiness, morning headache, difficulty concentrating, and mood changes.

[0019] Chest wall disorders are 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.

[0020] 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.

[0021] 2.2.2 Treatment

[0022] Various treatments, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), and invasive ventilation (IV), have been used to treat one or more of the above-mentioned respiratory diseases.

[0023] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure 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, or if so, in any of these ways.

[0024] Non-invasive 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 non-invasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as OHS, COPD, NMD, and chest wall diseases. In some forms, it can improve the comfort and effectiveness of these treatments.

[0025] Non-invasive ventilation (IV) provides ventilation 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.

[0026] 2.2.3 Treatment System

[0027] These treatments can be provided by treatment systems or devices. Such systems and devices can also be used to diagnose conditions without treating them.

[0028] The treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0029] 2.2.3.1 Patient Interface

[0030] 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.

[0031] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain suitable pressure. Masks for underwater swimming or diving may be configured to prevent water from flowing in from external high pressure, rather than maintaining air at a pressure higher than the environment inside.

[0032] Some masks may be clinically disadvantageous for this technology, for example, in cases where they block airflow through the nose and only allow it through the mouth.

[0033] If certain masks require patients to insert a portion of the mask structure into their mouths to form and maintain a seal through their lips, they may be uncomfortable or not feasible for this technology.

[0034] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0035] The design of the patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly from person to person. Because the head comprises bones, cartilage, and soft tissue, 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 the duration of a breathing therapy session.

[0036] Due to these challenges, some masks 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. Wrongly sized masks can lead to decreased compliance, reduced comfort, and adverse patient outcomes. Masks designed solely for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for administering anesthetics are acceptable for their original purpose, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment, especially if the mask is worn during sleep.

[0037] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing difficulties. However, if the mask is uncomfortable or difficult to use, patient adherence may be compromised. Since patients are often advised to wash their masks regularly, if the mask is difficult to wash (e.g., difficult to assemble or disassemble), patients may not wash their face with the mask, which could affect adherence.

[0038] 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.

[0039] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0040] 2.2.3.1.1 Sealing Formation Structure

[0041] Patient interfaces may include seal-forming structures. Because they come into direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0042] The patient interface is partially characterized by the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part and a second sub-part, the first sub-part forming a seal around the left nostril and the second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils during use. This single element may be designed, for example, to cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure 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 structure 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.

[0043] A sealing structure that works effectively in one area of ​​a patient's face may not be suitable for another, for example, due to the different shapes, structures, variations, and sensitive areas of the patient's face. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0044] Certain seal-forming structures 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 structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0045] One type of seal-forming structure extends around the periphery of a patient interface and, when force is applied to the patient interface while the seal-forming structure engages face-to-face with the patient's face, the seal-forming portion serves to seal the patient's face. The seal-forming structure may include an air- or fluid-filled pad, or a molded or shaped surface of an elastic sealing element made of an elastomer (e.g., rubber). With this type of seal-forming structure, 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.

[0046] Another type of seal-forming structure includes a wing-shaped seal of thin material positioned around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous type of seal-forming section, 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 structure does not match the patient's shape, it may wrinkle or bend during use, leading to leakage.

[0047] Another type of sealing structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0048] Another form of sealing can be achieved using adhesives. Some patients may find it inconvenient to constantly apply and remove adhesives from their face.

[0049] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0050] 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.

[0051] ResMed Ltd. has manufactured the following products that combine a nose pillow: SWIFT TM Nose pillow mask, SWIFT TMII Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and MIRAGE LIBERTY TM Full-face mask. The following patent application assigned to ResMed Ltd. describes an example of a nose pillow mask: International Patent Application WO 2004 / 073778 (which describes a ResMed Ltd. SWIFT mask). TM Other aspects of the nose pillow); U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc.'s SWIFT...) TM Other aspects of the LT nose pillow); International patent applications WO 2005 / 063328 and WO 2006 / 130903 (which describe ResMed Ltd. MIRAGE LIBERTY) TM Other aspects of the full-face mask); International Patent Application WO 2009 / 052560 (which describes ResMed Ltd.'s SWIFT) TM Other aspects of the FX nose pillow).

[0052] 2.2.3.1.2 Positioning and Stability

[0053] The sealing structure of the patient interface used in positive air pressure therapy is subjected to the corresponding force of air pressure that could disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain it in a sealed relationship with the appropriate part of the face.

[0054] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, using adhesives may be uncomfortable for some people.

[0055] Another technique involves using one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following: ill-fitting, bulky, uncomfortable, and awkward to use. When designed to be worn over a patient's head, this type of harness can be referred to as a headband.

[0056] 2.2.3.1.3 Pressurized air duct

[0057] In one type of treatment system, a pressurized airflow is supplied to the patient interface via a conduit in an air circuit fluidly connected to the patient interface, such that when the patient interface is positioned on the patient's face during use, the conduit extends forward away from the patient's face from the patient interface. This can sometimes be referred to as an "elephant trunk" type interface.

[0058] Some patients find the interface unsightly and are therefore reluctant to wear it, thus reducing patient compliance. Furthermore, the catheter connected to the interface in front of the patient's face can easily get tangled in bedding.

[0059] 2.2.3.1.4 Pressurized air ducts used for positioning / stabilizing the sealing structure

[0060] Alternative types of treatment systems seeking to address these problems 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 "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.

[0061] Philips DreamWear TM The nasal mask includes a headband tube. One problem with this mask is that the headband tube is made of silicone. This silicone tube can cause discomfort to the patient when it is in contact with their face. Additionally, the weight of the headband may cause discomfort for some patients during use.

[0062] Patient interfaces with headband-equipped catheters offer several advantages, such as avoiding the unsightly and protruding appearance of a catheter connected to the front of the patient's face. Furthermore, headband-equipped patient interfaces allow for extended wear while the patient sleeps, creating an effective seal against the face and enhancing patient comfort.

[0063] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0064] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned therapies, for example, by operating the device to generate an airflow for delivery to an airway interface. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Therefore, RPT devices can also be used as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0065] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, such as reliability, size, and weight requirements for medical devices. Furthermore, even devices designed for medical use may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0066] One example of a specific requirement for certain RPT devices is noise.

[0067] Noise output level table for existing RPT devices (for one sample only, measured at 10 cmH2O using the test method specified in ISO 3744 in CPAP mode).

[0068] RPT device name A-weighted sound pressure level dB(A) Year (approximately) <![CDATA[C-Series Tango TM > 31.9 2007 <![CDATA[C-Series Tango with Humidifier TM > 33.1 2007 <![CDATA[S8 Escape TM II]]> 30.5 2005 <![CDATA[With H4i TM S8 Escape of the humidifier TM II]]> 31.1 2005 <![CDATA[S9 AutoSet TM ]]> 26.5 2010 <![CDATA[With H5i TM S9 AutoSet of humidifier TM > 28.6 2010

[0069] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a CPAP machine. CPAP machines include ResMed Stellar... TM The series of adult and pediatric ventilator faces can support a range of patients for invasive and non-invasive non-dependent ventilation to treat a variety of conditions, such as, but not limited to, NMD, OHS and COPD.

[0070] Elisée TM 150 ventilator and ResMed VS III TM Ventilators provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients to treat a variety of conditions. These ventilators offer volumetric and pressure ventilation modes with single- or dual-branch circuits. RPT devices typically include a pressure generator, such as an electric motor-driven blower or a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, airflow to the patient's airway can be supplied under positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0071] The designer of a device may be presented with an almost infinite number of options. Design standards often conflict, meaning that some design choices are far from conventional or unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to small and subtle changes in one or more parameters.

[0072] 2.2.3.3 Humidifier

[0073] Delivering an unhumidified airflow can lead to airway dryness. Humidifiers with an RPT device and patient interface generate humidified air, minimizing dryness of the nasal mucosa and increasing patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around it is generally more comfortable than cold air. Therefore, humidifiers typically have the ability to heat the airflow and humidify it.

[0074] A range of artificial humidification devices and systems are known, however they may not meet the specific requirements of medical humidifiers.

[0075] When needed, typically in areas where patients may sleep or rest (e.g., in hospitals), medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to ambient air. Medical humidifiers intended for bedside placement can be very small. Medical humidifiers can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed by the patient; however, these systems also humidify and / or heat the entire room, which can cause discomfort to the occupant. Furthermore, medical humidifiers may have stricter safety restrictions than industrial humidifiers.

[0076] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide insufficient humidification, and some may be difficult or inconvenient for patients to use.

[0077] 2.2.3.4 Data Management

[0078] There are many clinical reasons to obtain data to determine whether a patient is “adhering” to a prescription treatment for respiratory therapy, such as if the patient has used their RPT device according to one or more “adherence rules.” One example of an adherence rule for CPAP therapy, to be considered adherent, requires the patient to use the RPT device for at least four hours each night for at least 21 or 30 consecutive days. To determine patient adherence, RPT device providers, such as healthcare providers, can manually obtain data describing the patient’s treatment with the RPT device, calculate usage over the predetermined time period, and compare it to the adherence rules. Once the healthcare provider has determined that the patient has used their RPT device according to the adherence rules, the healthcare provider can inform the patient of the third part of adherence.

[0079] Patient treatment can benefit from other aspects of communication between treatment data and third-party or external systems.

[0080] Existing methods for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0081] 2.2.3.5 Mandibular repositioning

[0082] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance, available from a dentist or other vendor, that holds the lower jaw (mandible) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes after falling asleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom-made or manufactured in standard form and include occlusal impression portions designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, applies tension to the pharyngeal walls to reduce airway constriction, and reduces vibration of the hard palate.

[0083] In some instances, a mandibular advancement device may include an upper splint designed to engage or engage with teeth in the maxilla or mandible, and a lower splint designed to engage or engage with teeth in the maxilla or mandible. The upper and lower splints are laterally connected together by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper and lower splints.

[0084] In this design, the length of the connecting rod is chosen so that the mandible remains in an advanced position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the degree of mandibular protrusion. The dentist can determine the degree of mandibular protrusion, which will then determine the length of the connecting rod.

[0085] Some MRDs are constructed to push the mandible forward relative to the maxilla, while other MADs (such as ResMed Narval CC) are designed to do so. TM The MRD (Mandibular Joint Retention Device) is designed to hold the mandible in an forward position. This device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0086] 2.2.3.6 Exhaust Port Technology

[0087] Some forms of patient interface systems may include vents to allow the flushing of exhaled carbon dioxide. Vents allow gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the external space of the patient interface, such as into the environment.

[0088] Vents may include orifices through which gas can flow when the mask is in use. Many of these vents are noisy. Others may become blocked during use, thus providing insufficient flushing. Some vents may, for example, disrupt the sleep of the patient's bed partner by causing noise or congested airflow.

[0089] ResMed has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; and U.S. Patent Application Publication No. US2009 / 0044808.

[0090] The noise level of the existing face mask (ISO 17510-2:2007, pressure at 1m and 10cmH2O)

[0091]

[0092] (*Only one sample was measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744)

[0093] The sound pressure levels of various objects are listed below.

[0094]

[0095] 2.2.4 Screening, Diagnosis and Monitoring System

[0096] Polysomnography (PSG) is a routine system used for the diagnosis and monitoring of cardiopulmonary diseases and typically involves specialized clinical healthcare professionals applying the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), and electromyography (EMG). PSG for sleep-disordered breathing has involved two nights of observation of the patient in the clinic: one night for pure diagnosis and a second night for the clinician to determine treatment parameters. PSG is therefore expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0097] Screening and diagnosis generally describe the identification of a disease from its signs and symptoms. Screening typically provides a true / false result, indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis provides clinically actionable information. Screening and diagnosis are often one-off processes, while monitoring disease progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0098] Clinicians can appropriately screen, diagnose, or monitor patients based on visual observation of PSG signals. However, there are situations where clinicians may be unavailable or unaffordable. Different clinicians may have differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. Summary of the Invention

[0099] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0100] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0101] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0102] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0103] One form of this technology includes a patient interface for delivering a pressurized breathable gas supply to a patient's airway.

[0104] Another aspect of this technology relates to at least one gas delivery pipe having an inner fabric layer and an outer fabric layer, wherein the inner fabric layer and the outer fabric layer have different cross-sectional shapes.

[0105] Another aspect of this technology relates to at least one gas delivery tube, comprising an inner fabric layer and an outer fabric layer. The inner fabric layer has a substantially planar cross-sectional shape and the outer fabric layer has a predetermined non-planar cross-sectional shape. The outer fabric layer is resilient, such that when subjected to an external force, the cross-sectional shape of the outer fabric layer changes, and when the external force is released, the outer layer returns to the predetermined non-planar cross-sectional shape.

[0106] Another aspect of this technology relates to a gas delivery pipe having an inner fabric layer and an outer fabric layer, wherein the outer fabric layer is thermoformed to have a predetermined shape and the inner fabric layer is not thermoformed.

[0107] Another aspect of this technology relates to at least one gas delivery tube having an inner fabric layer and an outer fabric layer. The inner and outer fabric layers are joined along a first longitudinal edge at a first joint and along a second longitudinal edge at a second joint, wherein the outer fabric layer is spaced apart from the inner fabric layer between the first and second joints, wherein the outer fabric layer is thermoformed to have a predetermined shape and the inner fabric layer is not thermoformed, and wherein the outer fabric layer supports its own weight between the first and second joints such that the outer fabric layer remains spaced apart from the inner fabric layer when not supported by pressurized air.

[0108] Another aspect of this technology relates to at least one gas delivery tube having an inner fabric layer and an outer fabric layer, wherein the outer fabric layer is more rigid than the inner fabric layer, wherein the inner fabric layer and the outer fabric layer are connected along a first longitudinal edge and a second longitudinal edge, and wherein an air passage is formed between the inner fabric layer and the outer fabric layer.

[0109] Another aspect of this technology includes a patient interface. The patient interface may include an inflation chamber pressurizable to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure. The inflation chamber may include an inflation chamber inlet port, sized and configured to receive an airflow at the therapeutic pressure for patient breathing. The patient interface may include a sealing formation structure configured and arranged to seal against a patient facial region surrounding an inlet to the patient's airway. The sealing formation structure may have an opening therein, allowing an airflow at the therapeutic pressure to be delivered to at least one inlet to the patient's nostril. The sealing formation structure may be configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use. The patient interface may include at least one gas delivery tube to deliver an airflow to the inlet of the patient's airway via the sealing formation structure, the at least one gas delivery tube being configured and arranged to contact at least one region of the patient's head above a supraacus base point. The at least one gas delivery tube may include an inner fabric layer and an outer fabric layer. The outer fabric layer may have a predetermined non-planar cross-sectional shape. The outer fabric layer can be elastic, such that when subjected to an external force, the cross-sectional shape of the outer fabric layer changes, and when the external force is released, the outer layer returns to a predetermined non-planar cross-sectional shape.

[0110] In the embodiments, (a) the inner fabric layer may have different material properties than the outer fabric layer; (b) the inner fabric layer may include an inner fabric membrane, wherein during use, when pressurized with air, the inner fabric membrane is configured to allow air to pass through it; (c) the inner fabric layer may include a shaped inner fabric membrane, and the outer fabric layer may include a shaped outer fabric membrane, wherein the outer fabric layer is thicker than the inner fabric layer; (d) the inner fabric layer may have a substantially planar cross-section; (e) the inner fabric layer may be loose; (f) the inner fabric layer may be fixed to the outer fabric layer, wherein the outer fabric layer applies tension to the inner fabric layer; and (g) the inner fabric layer may include an outer fabric membrane. The outer fabric layer comprises an outer fabric sheet and an inner fabric membrane, wherein the inner fabric membrane is configured to resist the transmission of air through the outer fabric sheet; (h) at least one gas delivery tube may be configured to extend continuously from the right side of the patient along the parietal bone to the left side of the patient; (i) at least one gas delivery tube may include an air supply conduit, wherein the air supply conduit is positioned adjacent to the parietal bone when the patient wears the patient interface; (j) the outer fabric layer may include an outer fabric sheet and an inner fabric membrane, wherein a conformal sheet is sandwiched between the outer fabric sheet and the inner fabric membrane; (k) the inner fabric layer may be connected to the outer fabric layer at a joint, wherein the width of the joint varies along the length of at least one gas delivery tube. (l) The outer fabric layer has an inner surface, wherein the inner surface of the outer fabric layer may have positive curvature; (m) The inner fabric layer may have zero curvature; (n) The inner and outer fabric layers may be joined together without stitching; (o) The inner fabric layer may include an inner inner fabric membrane, wherein the outer fabric layer may include an outer inner fabric membrane, wherein the outer inner fabric membrane of the outer fabric layer and the inner inner fabric membrane of the inner fabric layer are joined along the edge of at least one gas delivery tube, wherein the inner inner fabric membrane and the outer inner fabric membrane connect the inner fabric layer to the outer fabric layer and form an impermeable membrane between the inner and outer fabric layers; (p) The inner and outer fabric layers may be The first edge is connected by a first connector and joined by a second connector at the second edge, and spaced apart from each other between the first connector and the second connector, wherein no reinforcement is used along the inner fabric layer between the first connector and the second connector, (q) during use and by air pressure, the inner fabric layer can expand away from the outer fabric layer, (r) the outer fabric layer may include a conformal material, wherein the conformal material is thermoformed into a non-planar cross-sectional shape, (s) at least one gas delivery tube can be thermoformed into a predetermined shape such that the first arm extends along a first plane and the upper part extends along a second plane substantially perpendicular to the first plane without external force or pressure.

[0111] Another aspect of this technology includes a patient interface. The patient interface may include an inflation chamber pressurizable to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure. The inflation chamber may include an inflation chamber inlet port, sized and configured to receive an airflow at the therapeutic pressure for patient breathing. The patient interface may include a sealing formation structure configured and arranged to seal against a patient facial region surrounding an inlet to the patient's airway. The sealing formation structure may have an opening therein, allowing an airflow at the therapeutic pressure to be delivered to at least one inlet to the patient's nostril. The sealing formation structure may be configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use. The patient interface may include at least one gas delivery tube to deliver an airflow to the inlet of the patient's airway via the sealing formation structure, the at least one gas delivery tube being configured and arranged to contact at least one region of the patient's head above a supraacus base point. At least one gas delivery tube may include an inner fabric layer and an outer fabric layer, wherein the inner and outer fabric layers may be joined along a first longitudinal edge at a first joint and along a second longitudinal edge at a second joint. The outer fabric layer may be spaced apart from the inner fabric layer between the first and second joints. The outer fabric layer may support its own weight between the first and second joints, thereby maintaining the space between the outer fabric layer and the inner fabric layer when not supported by pressurized air.

[0112] In the examples described above, (a) the inner fabric layer may have different material properties than the outer fabric layer; (b) the inner fabric layer may include an inner fabric membrane, wherein during use, when pressurized with air, the inner fabric membrane is configured to allow air to pass through it; (c) the inner fabric layer may include a shaped inner fabric membrane, and the outer fabric layer may include a shaped outer fabric membrane, wherein the outer fabric layer is thicker than the inner fabric layer; (d) the inner fabric layer may have a substantially planar cross-section; (e) the inner fabric layer may be loose; (f) the inner fabric layer may be fixed to the outer fabric layer, wherein the outer fabric layer applies tension to the inner fabric layer; and (g) the inner fabric layer may include an outer fabric sheet. The outer fabric layer comprises an outer fabric sheet and an inner fabric membrane, wherein the inner fabric membrane is configured to resist the transmission of air through the outer fabric sheet; (h) at least one gas delivery tube may be configured to extend continuously from the right side of the patient along the parietal bone to the left side of the patient; (i) at least one gas delivery tube may include an air supply conduit, wherein the air supply conduit is positioned adjacent to the parietal bone when the patient wears the patient interface; (j) the outer fabric layer may include an outer fabric sheet and an inner fabric membrane, wherein a conformal sheet is sandwiched between the outer fabric sheet and the inner fabric membrane; (k) the inner fabric layer may be connected to the outer fabric layer at a joint, wherein the width of the joint varies along the length of at least one gas delivery tube; (l) the outer fabric layer... Having an inner surface, wherein the inner surface of the outer fabric layer has a positive curvature between the first joint and the second joint, (m) the inner fabric layer may have zero curvature between the first joint and the second joint, (n) the inner fabric layer and the outer fabric layer may be joined together without stitching, (o) the inner fabric layer may include an inner inner fabric membrane, wherein the outer fabric layer may include an outer inner fabric membrane, wherein the outer inner fabric membrane of the outer fabric layer and the inner inner fabric membrane of the inner fabric layer are joined along the edge of at least one gas delivery tube, wherein the inner inner fabric membrane and the outer inner fabric membrane connect the inner fabric layer to the outer fabric layer and form an impermeable membrane between the inner fabric layer and the outer fabric layer, (p) the inner fabric layer and The outer fabric layer may be joined at a first edge by a first joint and at a second edge by a second joint, and spaced apart from each other between the first joint and the second joint, wherein no reinforcement is used along the inner fabric layer between the first joint and the second joint; (q) during use and by air pressurization, the inner fabric layer may expand away from the outer fabric layer; (r) the outer fabric layer may include a conformal material, wherein the conformal material is thermoformed into a non-planar cross-sectional shape; (s) at least one gas delivery tube may be thermoformed into a predetermined shape such that a first arm extends along a first plane and an upper portion extends along a second plane substantially perpendicular to the first plane without external force or pressure.

[0113] Another aspect of this technology includes a patient interface. The patient interface may include an inflation chamber pressurizable to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure. The inflation chamber may include an inlet port sized and configured to receive an airflow at the therapeutic pressure for patient breathing. The patient interface may include a sealing formation configured and arranged to seal against a patient facial region surrounding an inlet to the patient's airway. The sealing formation may have an opening therein, allowing an airflow at the therapeutic pressure to be delivered to at least one inlet to the patient's nostril. The sealing formation may be configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use. The patient interface may include at least one gas delivery tube to deliver an airflow to the inlet of the patient's airway via the sealing formation, the at least one gas delivery tube being configured and arranged to contact at least one region of the patient's head above a supraacus base point. The at least one gas delivery tube may include an inner fabric layer and an outer fabric layer, wherein the outer fabric layer is more rigid than the inner fabric layer. The inner and outer fabric layers can be joined along the first and second longitudinal edges. Air passages can be formed between the inner and outer fabric layers.

[0114] In the example according to the preceding paragraph, (a) the outer fabric layer may have a predetermined non-planar cross-sectional shape, and wherein the outer fabric layer may be resilient such that when subjected to an external force, the shape of the outer fabric layer changes, and when the external force is released, the outer layer returns to the predetermined non-planar cross-sectional shape; (b) the outer fabric layer may be spaced apart from the inner fabric layer between a first longitudinal edge and a second longitudinal edge; and wherein the outer fabric layer may support its own weight between the first longitudinal edge and the second longitudinal edge, such that the outer fabric layer remains spaced apart from the inner fabric layer when not supported by pressurized air; (c) the inner fabric layer may include an inner fabric membrane, wherein during use, when pressurized with air, the inner fabric membrane is configured to allow air... (d) The inner fabric layer may include a shaped inner fabric membrane, and the outer fabric layer may include a shaped outer fabric membrane, wherein the outer fabric layer may be thicker than the inner fabric layer; (e) the inner fabric layer may have a substantially planar cross-section; (f) the inner fabric layer may be loose; (g) the inner fabric layer may be fixed to the outer fabric layer, wherein the outer fabric layer may apply tension to the inner fabric layer; (h) the inner fabric layer may include an outer fabric sheet and an inner fabric membrane, wherein the inner fabric membrane may be configured to resist air transmission through the outer fabric sheet; (i) at least one gas delivery tube may be configured to extend continuously from the right side of the patient along the parietal bone to the left side of the patient; (j) at least one gas delivery tube may include an air... An air supply catheter, wherein the air supply catheter is positioned adjacent to the parietal bone when the patient wears a patient interface, (k) the outer fabric layer may include an outer fabric sheet and an inner fabric membrane, wherein a conformal sheet is sandwiched between the outer fabric sheet and the inner fabric membrane, (l) the inner fabric layer may be connected to the outer fabric layer at a joint, wherein the width of the joint varies along the length of at least one gas delivery tube, (m) the outer fabric layer has an inner surface, wherein the inner surface of the outer fabric layer may have positive curvature between a first longitudinal edge and a second longitudinal edge, (n) the inner fabric layer may have zero curvature between the first longitudinal edge and the second longitudinal edge, (o) the inner and outer fabric layers may be joined together without sutures, (p) the inner fabric layer The outer fabric layer may include an inner and outer fabric membrane, wherein the outer and inner fabric membranes of the outer fabric layer are connected to the inner and outer fabric membranes of the inner fabric layer along the edge of at least one gas delivery tube, wherein the inner and outer fabric membranes connect the inner fabric layer to the outer fabric layer and form an airtight membrane between the inner and outer fabric layers, (q) the inner and outer fabric layers are connected at a first edge by a first joint and joined at a second edge by a second joint, and are spaced apart from each other between the first and second joints, wherein no reinforcement is used along the inner fabric layer between the first and second joints, (r) during use and by air pressurization, the inner fabric layer can expand away from the outer fabric layer.(s) The patient interface can be configured to allow the patient to breathe from the environment through their mouth without a pressurized airflow through the inlet port of the inflatable chamber, or the patient interface can be configured not to cover the patient's mouth; (t) the inflatable chamber can be made of a transparent material; (u) the patient interface can be configured such that no part of the patient interface enters the mouth during use; (v) the patient interface can be configured such that the sealing structure does not extend below the metal bulge area during use; (w) the patient interface can be constructed and arranged such that the inflatable chamber does not cover the eyes during use; (x) the patient interface can be configured such that the positioning and stabilizing structure provides at least (6 gf / cm) during use. 2 ) × Area occupied by the mask (cm²) 2 The patient interface can be configured to provide a holding force of less than 30 gf / cm² during use, and the positioning and stabilizing structure can be configured to provide a holding force of less than 30 gf / cm². 2 ) × Area occupied by the mask (cm²) 2 The force of (z) positioning and stabilizing structure can be configured to be breathable to allow wet vapor to escape and / or be transmitted through it.

[0115] Another aspect of this technology relates to a patient interface comprising: an inflation chamber; a sealing formation; an exhaust port structure; and a positioning and stabilizing structure that provides forces to hold the sealing formation in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes at least one gas delivery tube to receive an airflow from a connection port and deliver the airflow via the sealing formation to an inlet of the patient's airway, the gas delivery tube being configured and arranged to contact, in use, a region of the patient's head at least above an ear-based base.

[0116] Another aspect of this technology relates to a positioning and stabilizing structure including at least one gas delivery tube. The at least one gas delivery tube may include a non-patient contact portion comprising a first outer layer and a first inner layer comprising an impermeable material. The at least one gas delivery tube may also include a patient contact portion comprising a second outer layer configured to rest against a patient's head on a side of the gas delivery tube opposite the first outer layer during use, and a second inner layer comprising an impermeable material.

[0117] Another aspect of this technology relates to a positioning and stabilizing structure that provides force to hold 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 around the entrance to the patient's airway in a region of the patient's face for sealing and delivering an airflow at a therapeutic pressure at least 6 cmH2O above 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 receive an airflow from a connection port at the top of the patient's head and deliver the airflow to the entrance to the patient's airway via the sealing-forming structure. The gas delivery tube is configured and arranged to contact, during use, a region of the patient's head at least above a supraacus aponeurosis. The gas delivery tube includes a tube wall defining a hollow interior through which air can flow to the sealing-forming structure. The tube wall may include 1) a non-patient contact portion comprising a first outer layer and a first inner layer comprising an impermeable material; and 2) a patient contact portion comprising a second outer layer configured to rest against the patient's head on the side of the gas delivery tube opposite the first outer layer during use, and a second inner layer comprising an impermeable material.

[0118] In the examples: (a) the first outer layer comprises a fabric material; (b) the second outer layer comprises a fabric material; (c) the first inner layer comprises a thermoplastic material; (d) the second inner layer comprises a thermoplastic material; (e) a non-patient contact portion comprises a first intermediate layer between the first outer layer and the first inner layer; (f) the non-patient contact portion comprises a first adhesive layer bonding the first outer layer to the first intermediate layer; (g) the non-patient contact portion comprises a second adhesive layer bonding the first intermediate layer to the first inner layer; (h) the first intermediate layer comprises a foam material; (i) the first intermediate layer comprises a spacer textile; (j) the first intermediate layer is thicker than the first outer layer; (k) the patient contact portion comprises a second intermediate layer between the second outer layer and the second inner layer; (l) the patient contact portion comprises a first adhesive layer bonding the second outer layer to the second intermediate layer; (m) the patient contact portion comprises a second adhesive layer bonding the second intermediate layer to the second inner layer; (n) the second intermediate layer comprises a foam material; (o) the second intermediate layer comprises a spacer textile; and / or (p) the second intermediate layer is thicker than the second outer layer.

[0119] In a further example: (a) the non-patient contact portion includes a first adhesive layer bonding a first outer layer to a first inner layer; (b) the patient contact portion includes a first adhesive layer bonding a second outer layer to a second inner layer; (c) the patient contact portion and / or the non-patient contact portion are thermoformed into a certain shape; (d) the cross-section of the gas delivery tube is one of a dome shape, a trapezoidal shape, or a rectangle; (e) the width of the gas delivery tube varies from 24 mm to 18 mm along the length of the gas delivery tube; (f) the height of the gas delivery tube varies from 8 mm to 6 mm along the length of the gas delivery tube; and / or (g) each of the patient contact portion and the non-patient contact portion is elongated and each includes a front edge and a rear edge, the front edge being connected along the length of the gas delivery tube and the rear edge being connected along the length of the gas delivery tube.

[0120] In a further example: (a) the front edge connection forms a front seam of the gas delivery tube, and the rear edge connection forms a rear seam of the gas delivery tube; (b) the front seam and / or the rear seam are thermoformed; (c) the gas delivery tube includes an eyelet configured to connect to a rear strap of a positioning and stabilizing structure; (d) the eyelet is formed by a patient contact portion and / or a non-patient contact portion; and / or (e) the eyelet is formed by a seam connecting the rear edges of the patient contact portion and the non-patient contact portion.

[0121] According to another aspect of the present invention, there is a positioning and stabilizing structure that provides forces 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 around the inlet of the patient's airway in a region of the patient's face for sealing and delivering an airflow at a therapeutic pressure at least 6 cmH2O above 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 receive an airflow from the top of the patient's head and deliver the airflow to the inlet of the patient's airway via the sealing-forming structure. The gas delivery tube is configured and arranged to contact, in use, a region of the patient's head at least above a supraacus aponeurosis. The gas delivery tube includes a tube wall defining a hollow interior through which air can flow to the sealing-forming structure. The tube wall may include 1) an elongated patient contact portion configured to abut against the patient's head during use; and 2) an elongated non-patient contact portion on the side of the gas delivery tube opposite the patient contact portion, wherein the non-patient contact portion is drawn into a predetermined shape by the patient contact portion to form the hollow interior of the gas delivery tube.

[0122] In the example: (a) the gas delivery tube is biased toward an open configuration; (b) the non-patient contact portion is biased toward a flat shape; (c) the non-patient contact portion is biased by elasticity in one or more materials forming the non-patient contact portion; (d) the predetermined shape is a non-flat shape; (e) the cross-section of the gas delivery tube is trapezoidal; (f) the patient contact portion includes a non-flat shape; (g) the patient contact portion includes a shape that is flatter than the non-patient contact portion; (h) the patient contact portion is under tension along its width; (i) the patient contact portion is along... (j) Pulling the non-patient contact portion along the edge of its length; (k) Connecting the non-patient contact portion and the patient contact portion at a joint; (l) Each of the patient contact portion and the non-patient contact portion includes a front edge and a rear edge, the front edge being connected along the length of the gas delivery pipe and the rear edge being connected along the length of the gas delivery pipe; (m) The front edges are joined to form the front joint of the gas delivery pipe and the rear edges are connected to form the rear joint of the gas delivery pipe; (n) The front joint and / or the rear joint is thermoformed; (d) The patient contact portion and the non-patient contact portion are thermoformed.

[0123] In the example: (a) the patient contact portion and / or the non-patient contact portion includes multiple layers; (b) the patient contact portion includes a first outer layer, the first outer layer including a fabric or foam material; (c) the non-patient contact portion includes a second outer layer, the second outer layer including a fabric or foam material; (d) the patient contact portion and / or the non-patient contact portion includes an intermediate layer, the intermediate layer including a foam material or a spacer textile material.

[0124] In a further example: (a) the patient contact portion may be harder than the non-patient contact portion; (b) the non-patient contact portion may be more stretchable than the patient contact portion; (c) the patient contact portion may include a greater thickness than the non-patient contact portion; (d) the patient contact portion may include a centrally facing surface configured to abut against the patient's head, the centrally facing surface having a higher coefficient of friction relative to the patient's skin than the laterally facing surface of the non-patient contact portion.

[0125] In some instances, the positioning and stabilizing structure includes a pair of gas delivery pipes.

[0126] According to one aspect of the present invention, there is a positioning and stabilizing structure that provides forces 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 around an inlet to the patient's face, for sealing and delivering an airflow at a therapeutic pressure at least 6 cmH2O above 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 receive an airflow from a connection port at the top of the patient's head and deliver the airflow to the inlet of the patient's airway via the sealing-forming structure. The gas delivery tube is configured and arranged to contact, during use, a region of the patient's head at least above a supraacus aponeurosis. The gas delivery tube includes a tube wall defining a hollow interior through which air can flow to the sealing-forming structure. The tube wall may include 1) a patient contact portion including a first outer layer comprising a fabric or foam material configured to abut against the patient's head during use; and 2) a non-patient contact portion including a second outer layer comprising a fabric or foam material on a side of the gas delivery tube opposite to the first outer layer.

[0127] In the example: (a) the patient contact portion has greater rigidity than the non-patient contact portion; (b) the patient contact portion has greater thickness than the non-patient contact portion; (c) the patient contact portion is thermoformed by a first thermoforming process and the non-patient contact portion is thermoformed by a second thermoforming process, wherein the first thermoforming process provides greater rigidity to the patient contact portion than the second thermoforming process provides to the non-patient contact portion; (d) both the patient contact portion and the non-patient contact portion are formed of layers, with the patient contact portion having a greater number of layers than the non-patient contact portion; (e) the patient contact portion includes a rigidification layer; and (f) the patient contact portion includes a rigidification member.

[0128] In other instances, (a) the patient contact portion and / or the non-patient contact portion may include multiple layers; (b) the patient contact portion may include a first thermoplastic inner layer defining at least a portion of an air path within a gas delivery conduit; (c) the patient contact portion may include a first intermediate layer between a first outer layer and a first thermoplastic inner layer; (d) the patient contact portion may include a first adhesive layer bonding the first outer layer to the first intermediate layer; (e) the patient contact portion may include a second adhesive layer bonding the first intermediate layer to the first thermoplastic inner layer; and / or (f) the first intermediate layer may be formed of a foam material or a spacer textile material.

[0129] In a further example: (a) the non-patient contact portion may include a second thermoplastic inner layer defining at least a portion of an air path within a gas delivery conduit; (b) the non-patient contact portion may include a first adhesive layer bonding a second outer layer to the second thermoplastic inner layer; (c) alternatively, the non-patient contact portion may include a second intermediate layer between the second outer layer and the second thermoplastic inner layer; (d) the patient contact portion may include a first adhesive layer bonding a second outer layer to the second intermediate layer; (e) the patient contact portion may include a second adhesive layer bonding a second intermediate layer to the second thermoplastic inner layer; and / or (f) the second intermediate layer may be formed of a foam material.

[0130] In further examples: (a) the patient contact portion and / or the non-patient contact portion may be thermoformed into a certain shape; (b) the gas delivery tube may include a dome-shaped cross section; (c) the width of the gas delivery tube may vary from 34 mm to 18 mm along the length of the gas delivery tube; and / or (d) the height of the gas delivery tube may vary from 8 mm to 6 mm along the length of the gas delivery tube.

[0131] According to another aspect of the present invention, there is a positioning and stabilizing structure that provides forces 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 around an inlet to the patient's face, for sealing and delivering an airflow at a therapeutic pressure at least 6 cmH2O above 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 receive an airflow from the top of the patient's head and deliver the airflow to the inlet of the patient's airway via the sealing-forming structure. The gas delivery tube is configured and arranged to contact, during use, a region of the patient's head at least above a supraacus aponeurosis. The gas delivery tube includes a tube wall defining a hollow interior through which air can flow to the sealing-forming structure. The tube wall may include 1) a patient contact portion configured to abut against the patient's head during use; and 2) a non-patient contact portion on the side of the gas delivery tube opposite the patient contact portion.

[0132] In the examples: (a) the patient contact portion and / or the non-patient contact portion may include multiple layers; (b) the patient contact portion may include a first outer layer comprising a fabric or foam material; (c) the non-patient contact portion may include a second outer layer comprising a fabric or foam material; (d) the patient contact portion and / or the non-patient contact portion may include an intermediate layer comprising a foam material or a spacer textile material.

[0133] In further examples: (a) the gas delivery tube may include a dome-shaped cross-section; (b) the gas delivery tube may include a rectangular cross-section having two or more rounded corners; (c) the patient contact portion may be harder than the non-patient contact portion; (d) the non-patient contact portion may be more stretchable than the patient contact portion; (e) the patient contact portion may include a greater thickness than the non-patient contact portion; (f) the patient contact portion may include a centrally facing surface configured to abut against the patient's head, the centrally facing surface having a higher coefficient of friction relative to the patient's skin than the laterally facing surface of the non-patient contact portion.

[0134] In a further example: (a) the gas delivery tube can be biased into an open configuration; (b) the non-patient contact portion can be biased toward a flat shape and the patient contact portion can be stretched into a bent shape to create a hollow interior of the gas delivery tube; (c) each of the patient contact portion and the non-patient contact portion can be elongated and each includes a front edge and a rear edge, the front edge being joined along the length of the gas delivery tube and the rear edge being joined along the length of the gas delivery tube; (d) after the front and rear edges are joined, the patient contact portion and / or the non-patient contact portion can be under tension; (e) the front edges can be joined to form a front seam of the gas delivery tube, and the rear edges can be joined to form a gas delivery... (f) The front and / or rear seams of the gas delivery tube may be thermoformed; (g) The front seam may have a different stiffness than the rear seam; (h) The front seam may include a greater stiffness than the rear seam; (i) The front and / or rear seams may have a stiffness that varies along the length of the gas delivery tube; (j) The stiffness of the front and / or rear seams is greater in the lower portion of the gas delivery tube than in the upper portion; (k) The gas delivery tube may include eyelets configured to connect to a rear strap of a positioning and stabilizing structure; (l) The eyelets may be formed by a patient contact portion and / or a non-patient contact portion; (m) The eyelets may be formed by a seam connecting the rear edges of the patient contact portion and the non-patient contact portion.

[0135] According to one aspect of the present invention, there is a positioning and stabilizing structure that provides forces 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 around an inlet to the patient's airway in a region of the patient's face for sealing and delivering an airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use. The positioning and stabilizing structure may include at least one gas delivery tube for receiving an airflow from a connection port at the top of the patient's head and delivering the airflow to the inlet of the patient's airway via the sealing-forming structure. The gas delivery tube is configured and arranged to contact, during use, a region of the patient's head at least above a supraacus base point. The gas delivery tube includes a tube wall defining a hollow interior through which air can flow to the sealing-forming structure. The tube wall may include 1) a patient contact portion, including a first outer layer comprising a fabric or foam material configured to rest against a patient's head during use; and 2) a non-patient contact portion, including a second outer layer comprising a fabric or foam material on a side of the gas delivery tube opposite to the first outer layer, wherein at least one seam is formed by connecting the edge of the non-patient contact portion to a corresponding edge of the patient contact portion.

[0136] In the example: (a) at least one joint provides stiffness for at least one gas delivery pipe; (b) at least one joint is formed by a thermoforming process; (c) at least one joint includes stiffness provided by compressing the edges of the joint during the thermoforming process; and (d) at least one joint is welded.

[0137] In the example: (a) at least one gas delivery pipe includes an upper pipe portion and a lower pipe portion; (b) at least one seam in the lower pipe portion of the gas delivery pipe has greater rigidity than in the upper pipe portion; (c) at least one seam in the lower pipe portion is provided with greater rigidity by greater compression of the edge forming the seam in the lower pipe portion during the thermoforming process compared to the edge forming the seam in the upper pipe portion; (d) at least one seam in the lower pipe portion of the gas delivery pipe includes greater thickness; (e) at least one seam includes a greater width in the lower pipe portion of the gas delivery pipe than in the upper pipe portion.

[0138] In the examples: (a) at least one seam includes a front seam, wherein both the patient contact portion and the non-patient contact portion of the gas delivery tube include a front edge, and the front edges of the patient contact portion and the non-patient contact portion are joined to form a front seam; (b) at least one seam includes a rear seam, wherein both the patient contact portion and the non-patient contact portion of the gas delivery tube include a rear edge, and the rear edges of the patient contact portion and the non-patient contact portion are joined to form a rear seam; (c) at least one seam includes a front seam and a rear seam, wherein both the patient contact portion and the non-patient contact portion of the gas delivery tube include a front edge and a rear edge, the corresponding front edges are joined to form a front seam and the corresponding rear edges are joined to form a rear seam.

[0139] In the examples: (a) the front seam has greater rigidity than the rear seam; (b) the front seam has greater rigidity than the edge forming the rear seam, provided by greater compression of the edge forming the front seam during the thermoforming process; (c) the front seam has greater thickness than the rear seam; and (d) the front seam has greater width than the rear seam.

[0140] In the example: (a) at least one seam includes a rear seam, wherein both the patient contact portion and the non-patient contact portion of the gas delivery tube include a rear edge, the rear edges of the patient contact portion and the non-patient contact portion being joined to form a rear seam; (b) the rear seam includes a widening portion configured to connect with a strap of the positioning and stabilizing structure; (c) the rear seam includes an eyelet configured for connection with the strap; (d) the rear seam includes an aperture configured to receive the strap, the aperture allowing the strap to pass through and loop back and secure itself; (e) the eyelet in the rear seam includes a slit; (f) the positioning and stabilizing structure includes an eyelet rigidification portion configured to reinforce the eyelet; (g) the eyelet rigidification portion is disposed within the aperture in the rear seam and configured to reinforce the shape of the aperture; (h) the eyelet rigidification portion is substantially rigid.

[0141] According to one aspect of the present technology, a patient interface is provided. The patient interface may include 1) an inflatable chamber capable of being pressurized to a therapeutic pressure at least 6 cmH2O above ambient air pressure, the inflatable chamber including an inflatable chamber inlet port, the inflatable chamber inlet port being sized and configured to receive an airflow for patient breathing at the therapeutic pressure; 2) a sealing formation structure configured and arranged to form a seal with a region of the patient's face surrounding an inlet to the patient's airway, the sealing formation structure having an opening therein such that an airflow at the therapeutic pressure is delivered to at least one inlet of the patient's nostril, the sealing formation structure being configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use; 3) a positioning and stabilizing structure according to any of the foregoing aspects; and 4) an exhaust port structure allowing exhaled gas from the patient to flow continuously from the interior of the inflatable chamber to the surrounding environment, the exhaust port structure being sized and shaped to maintain the therapeutic pressure in the inflatable chamber during use, wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth without a pressurized airflow passing through the inflatable chamber inlet port, or the patient interface is configured not to cover the patient.

[0142] 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.

[0143] Another aspect of this technology is a patient interface that is cast or otherwise constructed using a peripheral shape that complements the shape of the intended wearer.

[0144] One aspect of this technology is a method for manufacturing components of a medical device.

[0145] 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.

[0146] 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.

[0147] 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.

[0148] 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.

[0149] 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.

[0150] 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.

[0151] 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.

[0152] 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 transferred to the surrounding environment via the exhaust port.

[0153] 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.

[0154] 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.

[0155] 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.

[0156] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for use by an untrained individual, by an individual with limited sensitivity or vision, or by an individual with limited experience in using this type of medical device.

[0157] One aspect of this technology is a portable RPT device that can be carried by an individual (e.g., around a personal home).

[0158] One aspect of this technology is a patient interface that can be cleaned at the patient's home (e.g., in soapy water) without the need for specialized cleaning equipment.

[0159] 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.

[0160] Other features of the present technology will become apparent from the following detailed description, abstract, drawings and claims. Attached Figure Description

[0161] 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:

[0162] 4.1 Treatment System

[0163] 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. The patient is sleeping in a supine position.

[0164] 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.

[0165] 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. The patient is sleeping in a lateral decubitus position.

[0166] 4.2 Respiratory System and Facial Anatomy

[0167] Figure 2A A 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.

[0168] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, 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.

[0169] Figure 2C It is a frontal 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.

[0170] Figure 2DIt 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.

[0171] 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.

[0172] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial groove, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and central sagittal plane.

[0173] Figure 2G A side view showing the surface features of the nose.

[0174] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0175] Figure 2I The diagram shows the medial anatomy of the nose, approximately a few millimeters from the central sagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0176] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also labeled.

[0177] Figure 2K A side view of the skull showing the surface contours of the head and several muscles is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0178] Figure 2L The frontal lateral view of the nose is shown.

[0179] 4.3 Patient Interface

[0180] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0181] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0182] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0183] Figure 3D A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a zero value.

[0184] Figure 3E A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0185] Figure 3F A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0186] Figure 3G A cushion for a face mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome-shaped and saddle-shaped areas are indicated.

[0187] Figure 3H The pad used for the face mask is shown. The outer surface of the pad is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle-shaped areas and one dome-shaped area are indicated.

[0188] Figure 3I The surface of the structure is shown, in which a one-dimensional hole is present. The planar curve shown forms the boundary of the one-dimensional hole.

[0189] Figure 3J It shows the way Figure 3I The cross-section of the structure. The surface defined is shown. Figure 3I Two-dimensional holes in the structure.

[0190] Figure 3K Show Figure 3I A perspective view of the structure, which includes two-dimensional holes and one-dimensional holes. A defined... Figure 3I The surface of a two-dimensional hole in a structure.

[0191] Figure 3L A face mask with an inflatable airbag as a cushion is shown.

[0192] Figure 3M It shows the way Figure 3L The cross-section of the mask is shown, and the inner surface of the airbag is also shown. The inner surface of the two-dimensional holes in the mask is defined.

[0193] Figure 3N It shows crossing Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0194] Figure 3O The left-hand rule is shown.

[0195] Figure 3P The right-hand rule is shown.

[0196] Figure 3Q The left ear is shown, including the left ear spiral.

[0197] Figure 3R The right ear is shown, including the right ear spiral.

[0198] Figure 3S The right-handed spiral is shown.

[0199] Figure 3T A view of the face mask is shown, which includes torsion marks of spatial curves defined by the edges of sealing membranes in different areas of the face mask.

[0200] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0201] Figure 3V Shown Figure 3U This is a view of the rear of the inflation chamber. The view is oriented perpendicular to the center contact plane. Figure 3V The sagittal plane divides the inflation chamber into the left and right sides.

[0202] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, which is taken from Figure 3V The sagittal plane is shown. The "intermediate contact" plane is shown. The intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and makes contact with the pad of the air chamber at two points on the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the pad in the region, the intermediate contact plane can be tangent at both the upper and lower points.

[0203] Figure 3X Shown Figure 3UThe air chamber 3200 is positioned for use on the face. When the air chamber is in the use position, the sagittal plane of the air chamber 3200 typically coincides with the central sagittal plane of the face. When the air chamber is in the use position, the intermediate contact plane typically corresponds to the "plane of the face". Figure 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is roughly located on the bridge of the nose, while the lower point 3230 is located on the upper lip.

[0204] Figure 4A An isometric view of a patient interface device according to an example of this technology is shown.

[0205] Figure 4B An isometric view of the patient interface worn by the patient is shown.

[0206] Figure 4C A side view of the patient interface worn by the patient is shown.

[0207] Figure 4D A top view of the patient interface worn on the patient is shown.

[0208] Figure 4E An isometric view of the tube of the patient interface in planar configuration when placed on a flat surface is shown.

[0209] Figure 4F A proportional cross-section of a portion of the tube is shown.

[0210] Figure 4F-1 The enlarged portion of the tube's layers is shown.

[0211] Figure 4F-2 The enlarged portion of the tube's layers is shown.

[0212] Figure 4G As shown Figure 4C A cross-section of a portion of the patient interface shown.

[0213] Figure 4H As shown Figure 4C A cross-section of a portion of the patient interface shown.

[0214] Figure 4I The possible cross-sectional shape of the tube for the patient interface is shown.

[0215] Figure 4J Another possible cross-sectional shape of the tube for the patient interface is shown.

[0216] Figure 4K Another possible cross-sectional shape of the tube for the patient interface is shown.

[0217] Figure 4L-1 An isometric view of a tube in a predetermined three-dimensional configuration is shown.

[0218] Figure 4L-2 This is a side view of a portion of the pipe.

[0219] Figure 4L-3 This is a front view of a part of the pipe.

[0220] Figure 4L-4 This is a top view of a portion of the pipe.

[0221] Figure 4M A scaled sectional view of the connection port inside the pipe is depicted.

[0222] Figure 4N An isometric view depicting the isolated connection ports is shown.

[0223] Figure 4O An isometric view depicting the connection portion in an alternative form.

[0224] Figure 4P The connection between the mask and the tube is depicted.

[0225] Figure 4Q Option forms of connectors for attaching face masks to tubes are described.

[0226] Figure 4R An isometric view of a patient interface based on another instance of this technology worn by a patient is shown.

[0227] Figure 4S This is a perspective view of the patient interface based on another instance of the disclosed technology.

[0228] Figure 4T It is a front perspective view of the upper connector of the positioning and stabilization structure based on an example of the disclosed technology.

[0229] Figure 4U It is a side perspective view of the lower connector of the positioning and stabilization structure based on an example of the disclosed technology.

[0230] Figure 4V yes Figure 4S A diagram illustrating the positioning and stabilizing cross-section of the structure.

[0231] Figure 4W This is a cross-sectional view of the outer layer of the positioning and stabilizing structure according to another example of the disclosed technology.

[0232] Figure 4X This is a perspective view of the patient interface based on another instance of the disclosed technology.

[0233] Figure 5A A view depicting the straps of the patient interface.

[0234] Figure 5BA side view depicting a portion of the strap is shown.

[0235] Figure 5C A partial exploded view depicting a portion of strap 3420.

[0236] Figure 5D and 5E A portion of the strap is depicted in both untensioned and tensioned states.

[0237] Figure 5F An alternative patient interface, including a replacement headband, is described.

[0238] Figure 5G Depicts Figure 5F A separate top view of the head strap.

[0239] Figure 5H An exploded isometric view of the head strap is depicted.

[0240] Figure 6A An isometric top view depicting the sealing formation structure used in the patient interface is shown.

[0241] Figure 6B An isometric bottom view depicting the sealing structure of the patient interface is shown.

[0242] Figure 6C An isometric view of the sealing layer depicting the sealing structure is shown.

[0243] Figure 6D An isometric view of the cross-section of the sealing layer is depicted.

[0244] Figure 6D-1 An enlarged view of a portion of the sealing layer is depicted.

[0245] Figure 6E The sealing structure attached to the frame is depicted.

[0246] Figure 7A A mold for forming a sealing layer is depicted.

[0247] Figure 7B The image depicts a fabric sheet positioned to engage with a mold.

[0248] Figure 7C The image depicts a sheet of fabric that is adjacent to a mold and unfolded on the mold using rollers.

[0249] Figure 7D The image depicts a fabric sheet pressed into the form of a mold.

[0250] Figure 7E The film layer applied to a fabric sheet inside the mold is depicted.

[0251] Figure 7FIt describes the process of subjecting the film to heating.

[0252] Figure 7G The process of removing the cured layer from the mold is described.

[0253] Figure 7H The process of cutting and shaping the sealing layer is described.

[0254] Figure 7I The image depicts a flat sheet of material pre-cut before being inserted into a mold.

[0255] Figure 7J The sheet material after being applied within the mold is depicted.

[0256] Figure 8A The image depicts a sheet of material placed on a mold to form a tube.

[0257] Figure 8B The sheet material inside the mold is depicted.

[0258] Figure 8C The method describes positioning the film layer to interact with the sheet within the mold.

[0259] Figure 8D The process of heating the film to solidify it into the shape of a mold is described.

[0260] Figure 8E It depicts attaching two cured sheets together.

[0261] Figure 8F A portion of a tube formed from two sheets is depicted.

[0262] Figure 8G The sheet material positioned above the mold is depicted.

[0263] Figure 8H It describes the process of spraying a film layer onto a sheet while the sheet is in a mold. Figure 8I The sheet and film layers inside the mold are depicted.

[0264] Figure 8J The process of removing the cured layer from the mold is described.

[0265] Figure 8K A tube formed by two cured layers is depicted.

[0266] Figure 8L and 8M Another method for forming tubes used in patient interfaces is described.

[0267] Figure 9A and 9B A method for forming tubes with alternative forms is described.

[0268] Figure 9CAn alternative form of tube 3450 is depicted.

[0269] Figure 9D and 9E Depicts Figure 9C The cross-section of tube 3450 in both inflated and deflated states.

[0270] Figure 10 A perspective view of a patient interface 9000 according to an example of this technology is shown.

[0271] Figure 11 A perspective view of a patient interface 10000 according to another example of this technology is shown.

[0272] Figure 12A and 12B This is a detailed view of a headband tube connector according to an example of this technology.

[0273] Figure 13 A perspective view of the gas delivery tube 9350 of a patient interface 9000 according to another embodiment of the present technology is shown.

[0274] Figure 14 Shown Figure 11 Cross-sectional view of the gas delivery pipe 9350.

[0275] Figure 15 A cross-sectional view of a gas delivery pipe 9350 according to another example of the present technology is shown.

[0276] Figure 16 A cross-section of a gas delivery pipe 9350 according to another example of the present technology is shown.

[0277] Figure 17 A cross-sectional view of the non-patient contact portion 9349 of a gas delivery tube according to another embodiment of the present technology is shown.

[0278] Figure 18 A side view of a patient interface 9000 according to another example of this technology is shown.

[0279] Figure 19 A perspective view of a patient interface 9000 according to another example of this technology is shown.

[0280] Figure 20 A perspective view of a patient interface 9000 according to another example of this technology is shown.

[0281] Figure 21 Shown Figure 20 The left-side view of the patient interface 9000.

[0282] Figure 22 Shown Figure 20The right-side view of the patient interface 9000.

[0283] Figure 23 It shows Figure 20 The front view of the patient interface 9000.

[0284] Figure 24 It shows Figure 20 The patient interface 9000 is shown in the front view of the coronal connector 9360 and the bend 9610.

[0285] Figure 25 It shows Figure 20 A perspective view of the coronal connector 9360 of the patient interface 9000.

[0286] Figure 26 It shows Figure 20 A perspective view of the patient interface 9000 headband tube 9350.

[0287] Figure 27 It shows Figure 20 The patient interface 9000 has a headband tube 9350 and an upper tube portion 9304 with a cross-section.

[0288] Figure 28 It shows Figure 20 The cross-section of the lower tube portion 9363 of the patient interface 9000 headband tube 9350.

[0289] Figure 29 It shows Figure 20 The patient interface 9000 has a headband tube 9350 with an upper tube portion 9304 cross-section, which has some marked forces.

[0290] Figure 30 It shows Figure 20 The patient interface is 3000, the headband tube is 3350, and the connector is 3320.

[0291] 4.4RPT device

[0292] Figure 31A An RPT device of one form according to the present technology is shown.

[0293] Figure 31B This is a schematic diagram of the pneumatic path of one form of RPT device according to the present technology. The upstream and downstream directions are shown with reference to the blower and patient interface. The blower is defined upstream of the patient interface, and the patient interface is defined downstream of the blower, regardless of the actual flow direction at any given moment. Articles within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0294] Figure 31CThis is a schematic diagram of the electrical components of one form of RPT device according to the present technology.

[0295] 4.5 Humidifier

[0296] Figure 32A This is an isometric view of one form of humidifier according to this technology.

[0297] Figure 32B 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. Detailed Implementation

[0298] 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 instances described herein only and is not intended to be limiting.

[0299] 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 instance may be combined with one or more features of another instance or other instances. Furthermore, in any instance, any single feature or combination of features may constitute another instance.

[0300] 5.1 Treatment

[0301] In one form, the technology includes a method for treating respiratory disorders, the method comprising the step of applying positive pressure to the airway inlet of a patient 1000.

[0302] In some instances of this technique, positive pressure air is supplied to the patient’s nasal passages through one or both nostrils.

[0303] In some instances of this technology, mouth breathing is limited, restricted, or prevented.

[0304] 5.2 Treatment System

[0305] 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 leading to a patient interface 3000.

[0306] 5.3 Patient Interface

[0307] refer to Figure 3AAccording to one aspect of the present technology, the noninvasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an exhaust port 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. 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. In use, the sealing-forming structure 3100 is arranged around the inlet of the patient's airway to facilitate the supply of positively pressurized air to the airway.

[0308] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0309] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply with a positive pressure of at least 6 cmH2O relative to the environment.

[0310] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply with a positive pressure of at least 10 cmH2O relative to the environment.

[0311] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply with a positive pressure of at least 20 cmH2O relative to the environment.

[0312] 5.3.1 Sealing Formation Structure

[0313] In one form of this technology, the sealing forming structure 3100 provides a target sealing forming area and may additionally provide a cushioning function.

[0314] The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual seal surface—may vary daily during a given treatment period and vary from patient to patient, depending on a range of factors such as the location of the patient interface on the face, the tension in the positioning and stabilizing structures, and the shape of the patient's face.

[0315] In one embodiment, the target sealing formation area is located on the outer surface of the sealing formation structure 3100. The sealing formation structure 3100 according to the present technology may be constructed from a soft, flexible, and resilient material such as silicone or other biocompatible materials.

[0316] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure acting on its bottom surface within the inflation chamber 3200, thereby forming a tight seal with the face. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0317] In one form, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or gasket seal portion is constructed and arranged to be compressed, for example, due to elastic tension in the positioning and stabilizing structure.

[0318] In one form, the sealing structure includes a tension section. During use, the tension section maintains tension, for example, through adjacent areas of the sealing flange.

[0319] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0320] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or bonding surface.

[0321] 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.

[0322] 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 and edges of the inflation chamber 3200, and at least a portion of the path extending around the periphery. 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 within the inflation chamber 3200, thereby forming a tight sealing engagement with the surface.

[0323] In another form, the sealing portion of the non-invasive patient interface includes a pair of nasal sprays or nasal pillows, each configured and arranged to form a seal with a corresponding nostril of the patient's nose. According to one aspect of the technology, the nasal pillow 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 that connects the truncated cone to the handle. Furthermore, the nasal pillow-connecting structure of the 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-connecting structure in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the handle-connecting structure.

[0324] In one form, the sealing-forming structure is configured for use with the underside of the nose around the nostrils and optionally with the upper lip to form a seal. This type of sealing-forming structure may be referred to as a "nasal support pad" or "nasal undermask," such as the sealing-forming structure 3100 of the non-invasive patient interface 3000. The shape of the sealing-forming structure may be configured to match or closely follow the underside of the patient's nose; that is, the contour and angle of the sealing-forming structure may be substantially parallel to the patient's nasolabial angle. In one form of nasal support pad, the sealing-forming structure includes a diaphragm member defining two orifices, each orifice supplying air or breathable gas to a different one of the patient's nostrils during use. The diaphragm member may 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. For example, in Figures 4A-4D Nasal stent interface 3000 is also shown in 10 and 11. In some instances, the patient interface may include a stent pad form of sealing structure 9100 as described in PCT Publication WO 2018 / 176094, filed March 29, 2018, the entire contents of which are incorporated herein by reference.

[0325] 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., the upper lip), the bridge of the nose region, and the cheek region of the patient's face. | This is, for example Figure 1B The patient interface 3000 is shown in the illustration. The sealing portion supplies air or breathable gas to both nostrils of the patient 1000 through a single orifice. This sealing structure can be referred to as a "nasal pad" or "nasal mask." In some embodiments of this technology, positioning and stabilizing structures are used to hold the nasal pad in a sealed position on the patient's face.

[0326] In one form, the non-invasive patient interface 3000 includes a sealing-forming portion that, during use, forms a seal on the chin, bridge of the nose, and cheek areas of the patient's face. This is, for example... Figure 1C The patient interface 3000 is shown in the illustration. The sealing portion supplies air or breathable gas to the patient's two nostrils and mouth through a single orifice. This sealing structure can be referred to as a "full face mask." In some instances of this technology, positioning and stabilizing structures are used to hold the full-face pad in a sealed position on the patient's face.

[0327] In another form, the patient interface 3000 includes a nasal seal-forming structure and an oral seal-forming structure in the form of a nasal pad or nasal support pad, the oral seal-forming structure being configured to form a seal around the patient's mouth (which may be referred to as a "mouth pad" or "oral mask") during use. In this mask, air or breathable gas is supplied to the patient's nostrils and mouth during use through separate openings. This seal-forming structure 3100 may be referred to as an "oronasal pad" or an "ultra-compact full-face pad." In one form, the nasal seal-forming structure and the oral seal-forming structure are integrally formed as a single component. In some instances, the patient interface may include a seal-forming structure in the form of a support pad as described in U.S. Patent Application No. 62 / 649,376 (corresponding to PCT Publication PCT / AU2019 / 050278, filed March 28, 2019), the entire contents of which are incorporated herein by reference. In some instances of this technology, positioning and stabilizing structures of the patient interface may be used to hold the oronasal pad in a sealed position on the patient's face.

[0328] In some instances of the prior art, in the area forming a seal during use, the air chamber 3200 has a periphery shaped to complement the surface contours of a typical human face. During use, the boundary edges of the air chamber are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure. The sealing structure can extend along the entire periphery of the air chamber during use. In some forms, the air chamber and the sealing structure are formed from a single, uniform sheet of material.

[0329] In some forms of this technology, the air chamber does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the air chamber. Such a form tends to be less conspicuous and / or more comfortable for the wearer, which can improve treatment compliance.

[0330] In some forms of this technology, the inflation chamber is made of a transparent material, such as transparent polycarbonate. The use of transparent materials reduces the prominence of the patient interface and helps improve treatment compliance. The use of transparent materials also helps clinicians observe how the patient interface is positioned and functions.

[0331] In some forms of this technology, the air chamber is made of a translucent material. The use of translucent materials can reduce the protrusion of the patient interface and help improve treatment compliance.

[0332] In some forms of the technology, the sealing structure 3100 is configured such that the sealing structure does not extend below the metal bulge area of ​​the patient's head during use.

[0333] Unless otherwise explicitly stated, embodiments of the patient interface according to this technology may include any of the sealing formation structures of the types described above.

[0334] 5.3.2 Sealing Formation Structure Configuration

[0335] In some forms of this technology, the sealing structure 3100 (also referred to as a cushioning structure, conformal structure, or interface structure) is made of textile or fabric material. For example, the sealing structure 3100 can be woven, nonwoven, knitted, or any other fiber web. A sealing structure 3100 formed of fabric material increases the comfort and tactile feel of the sealing structure relative to the patient's face. Increased comfort increases the likelihood that the patient can continue to receive treatment using the device.

[0336] These sealing structures can be used to form a surface that presses against a patient's face to deliver air to the patient's nose and / or mouth. Unlike silicone or other materials, some patients may feel the texture of fabric material against their face. The sealing structures can be formed using similar techniques and methods, as described later in this detailed description with reference to tubing and air delivery systems. For example, cutting and sealing methods, as well as laying methods, can be used.

[0337] In use, this technology can be used to form various components. In some forms, the mask component of the treatment device can be formed using a lamination manufacturing method. In one form, a release agent is placed on a mold. Next, layers for masking are placed inside the mold. The layers can be formed from various materials. In some forms, the layers can be fabric-type materials. In other forms, the layers can be plastics, thermoplastics, rubber, silicone, or other flexible or bendable materials.

[0338] Reference Figure 6A and 6BThe figure depicts a sealing structure incorporating a fabric. As shown, the sealing structure 3100 includes a sealing layer 3102 and a base 3104. The sealing layer 3102 can be fixed to the base 3104, allowing the entire sealing structure 3100 to be attached to a receiving seat, which is attached to a supply conduit, such as a tube 3350. As shown, the sealing layer 3102 includes a predefined three-dimensional shape. This predefined three-dimensional shape is achieved without the aid of air pressure or additional support structures beyond the material of the sealing layer 3102 itself. The predetermined three-dimensional shape is not defined by the thickness of the material forming the sealing layer 3102, but rather by the geometrical position of the various portions of the sealing layer 3102. For example, the sealing layer 3102 is configured from its material, which is bent into various planes, to maintain its shape within these various planes.

[0339] like Figures 6A-6E As shown, the sealing layer 3102 can be formed to specifically interact and engage with the patient's nasal cavity region. When worn by a patient, the upper surface of the sealing layer 3102 can be configured to engage with specific portions of the patient's face. For example, portions adjacent to the first nostril opening 3108 and the second nostril opening 3110 can be configured to engage with the patient's nasal alae, while the saddle-shaped region 3109 can be spaced apart from the patient's columella. Furthermore, the nasolabial groove engagement region 3106 can be formed to engage with the patient's nasolabial groove. Additionally, the sealing structure 3100 is configured such that it does not obstruct the patient's mouth, allowing the patient to breathe through his or her mouth without pressurized air passing through it. Furthermore, as... Figures 6A-6E As shown, the sealing layer 3102 is formed in such a way that it does not extend along the bridge of the nose. For example, in use, the sealing layer 3102 at least does not cover the lateral cartilage portion, the nasal bone, and the septal cartilage (see...). Figure 2L ).

[0340] While some forms do not require air pressure to support the shape of the sealing layer 3102, portions of the sealing layer 3102 can be reinforced with air pressure to facilitate a good seal between the sealing layer 3102 and the patient's face. For example, in some forms, an accordion-shaped portion of the sealing layer 3102 may be formed adjacent to the base 3104. When pressure is applied, the accordion-shaped portion can expand, thereby providing additional sealing pressure between the sealing layer 3102 and the patient's face. Furthermore, other portions of the sealing layer 3102 may be configured to expand to engage with specific areas of the patient's face, such as the nasolabial folds.

[0341] The sealing layer 3102 can be deformable, allowing it to deform when pressed with a normal amount of force when used with the patient interface 3000. The sealing layer 3102 can conform to the shape of various parts of the patient's face, minimizing air leakage. Once removed from the patient's face, the sealing layer 3102 can elastically return to its original shape before deformation. That is, once force is released from the sealing layer 3102, it returns to its unpressurized state, at which point it has a three-dimensional shape.

[0342] The sealing layer 3102 can be formed from various layers, making it a laminated structure. Each layer can impart specific properties to the sealing layer 3102. In one form of this technology, the sealing layer 3102 comprises a thermoplastic or thermosetting material. Once cured into this shape, the material is able to maintain a specific shape. For example, in one form, the sealing layer 3102 may comprise a thermosetting material, such as a foam material. Thermosetting materials can conform to a mold and maintain the shape of the mold, such as... Figures 7A-7H As shown.

[0343] The sealing layer 3102 can be configured to press against a specific area of ​​the nose or nasal region. For example, the nasolabial fold region 3106 can be configured to press against the patient's nasolabial fold region. Additionally, other areas of the sealing layer 3102 can be specifically shaped to correspond to the patient's face. The sealing layer 3102 includes a first nostril opening 3108 and a second nostril opening 3110 configured to align with each of the patient's nostrils. Furthermore, the sealing layer 3102 includes a saddle-shaped region 3109 located between the first nostril opening 3108 and the second nostril opening 3110. The saddle-shaped region 3109 extends away from the user's columella during use, such that the material of the sealing layer 3102 is spaced apart from the patient's nose to increase comfort.

[0344] The sealing layer 3102 can also be specifically shaped such that the surface sealed to the patient's face is spaced apart from the base 3104. By separating the sealing layer 3102 from the base 3104, a buffer region can be formed between the softer surface of the sealing layer 3102 and the harder component of the base 3104. For example, as Figure 6D As shown, the sealing layer 3102 has a height 3111 that spaces the mating surface of the sealing layer 3102 from other components of the patient interface 3000. In addition to having a height 3111, as shown throughout the figures, the sealing layer 3102 can have various regions that, among other configurations, have positive and negative curvatures, saddle-shaped regions, and domes. Specific shapes of the sealing layer can be formed to engage with the patient's airway. These specific shapes can be formed using molds with complex shapes or other techniques described in this detailed description.

[0345] In some forms, the first nasal opening 3108 and the second nasal opening 3110 can be raised from their surrounding surfaces. That is, in some forms, the material surrounding the first nasal opening 3108 and the second nasal opening 3110 includes a flange 3107 extending from the surface of the sealing layer 3102 toward the user's nostril. By raising a specific area of ​​the sealing layer 3102, a better or more secure fit can be obtained than in other forms of technology. For example, the first nasal opening 3108 and the second nasal opening 3110 can engage with the nasal wall corresponding to the columella, alar, or other parts of the nostril. The flange 3107 provides stability, allowing movement of the first nasal opening 3108 and the second nasal opening 3110 away from the nostril. This alignment provided by the first nasal opening 3108 and the second nasal opening 3110 can provide a consistent oxygen delivery to the patient. In some forms, the first nasal opening 3108 and the second nasal opening 3110 can be shaped as a substantially truncated cone. In other forms, the shape of these openings may not taper like a truncated cone, and instead, flange 3107 may extend vertically. In other forms, the shape of the openings may be formed to engage with the inner surface of the nostril. In other forms, the material around the first nostril opening 3108 and the second nostril opening 3110 may be uniformly aligned with the material around the sealing layer 3102.

[0346] Furthermore, the height or depth of the flanges 3107 of the first nasal opening 3108 and the second nasal opening 3110 can be specifically formed. Some patients may prefer this configuration, which allows the openings to extend a greater distance into the patient's nostrils compared to other patients. Therefore, the depth of the flanges 3107 of the first nasal opening 3108 and the second nasal opening 3110 can be adjusted according to the preferences of the patient or medical professional. The flanges 3107 can be formed in a manner similar to the rest of the sealing structure 3102, wherein foam or thermosetting material can be used to maintain the shape of the flange, even without air pressure or other rigid types of material. The shape of the nostrils can also depend on the shape of the mold used to form the sealing layer 102, such as... Figures 7A-7H As shown.

[0347] In some forms, the sealing layer 3102 may be specifically arranged to include more rigid and less rigid regions corresponding to specific areas of the patient. The sealing layer 3102 may include a more rigid or firmer portion along the nasolabial fold region 3106, wherein the sealing layer 3102 is configured to engage with the patient's nasolabial fold. This region of the face is less sensitive than other areas of the face, and therefore a thicker or more rigid portion can be used to provide a robust structure for sealing. Other regions of the sealing layer 3102 may include softer or less rigid structures. For example, the flange 3107 of the sealing layer 3102 that may contact the patient's columella may be less rigid so as not to disturb the patient.

[0348] In some forms, the stiffness or hardness of the sealing layer 3102 can be varied or determined by the amount or quantity of membrane material (e.g., a thermoplastic material applied to the inner surface of the sealing layer 3102). In other forms, the stiffness or hardness of the sealing layer 3102 can be determined based on the amount of material used. For example, in some forms, the sealing layer 3102 includes bending or folding that increases the thickness or density of the sealing layer 3102 at specific locations. Thus, by folding the material of the sealing layer 3102 in a specific manner, rigid regions of the sealing layer 3102 can be formed without additional membrane material or supports.

[0349] The sealing layer 3102 can be secured to the base 3104. The base 3104 may include clips to allow the sealing forming structure 3100 to be easily removed from the receiver of the frame 3152 of the patient interface 3000 (see, for example). Figure 6E Additionally, the base 3104 can be harder or more rigid than the sealing layer 3102. Therefore, the base 3104 can resist bending along the edge of the sealing layer 3102, so that when the sealing layer 3102 of the sealing forming structure 3100 is pressed down, the side of the sealing layer 3102 remains in a fixed position.

[0350] Alternatively, other forms of sealing layers 3102 can be used. For example, in some forms, a full-face mask can be used instead of a sealing structure that supplies air only to the nose. In other forms, a mask that supplies air only to the mouth can be used. Various configurations can also be used. For example, in some forms, a single hole or cavity can be used instead of separate holes for each nostril. Furthermore, in some forms, the sealing structure can be designed to receive the nose, while in other designs, the sealing structure can be designed to adjoin the surface of the nose without surrounding or encircling it. Additionally, the mask or sealing structure can be designed for particular comfort. For example, in some forms, the nasal mask can be designed such that the tip or nasal protuberance of the patient is spaced apart from the mask. The nasal protuberance is often a sensitive area of ​​the nose, so designing the mask to space the nasal protuberance from the mask can increase patient comfort.

[0351] The cross-section of sealing layer 3102 is depicted in Figure 6D An enlarged view of a portion of the sealing layer 3102 is depicted in Figure 6D-1In the figure, the membrane layer 3118 is positioned along the inner surface of the sealing layer 3102. The fabric sheet 3116 is positioned along the lower opposite surface of the sealing layer 3102. The thickness of the membrane layer 3118 can be determined or changed during manufacturing according to manufacturing requirements. For example, a thicker membrane layer 3118 can provide greater rigidity than a thinner membrane layer 3118. A thinner membrane layer 3118 can allow the sealing layer 3102 to better conform to the patient's face. In some forms, the thickness of the sealing layer 3102 is determined solely by the thicknesses of the membrane layer 3118 and the fabric sheet 3116. That is, in some forms, no additional components such as reinforcements are used to maintain the shape of the sealing layer 3102. For example, the sealing layer 3102 can be easily deformed along all portions of the sealing layer 3102.

[0352] As previously stated, the nasolabial fold junction region 3107 may have a different material thickness than the adjacent portion of the sealing layer 3102. For example, a larger amount of film may be applied to the nasolabial fold junction region 3107 along the inner surface of the sealing layer 3102. Additional material can increase the thickness and stiffness of the nasolabial fold junction region 3107.

[0353] In addition to providing structure and support for the sealing layer 3102, the membrane layer 3118 may also include air within the sealing layer 3102. That is, in some forms, the membrane layer 3118 can prevent air from passing through the material of the sealing layer 3102. Thus, the membrane layer 3118 can guide air from the treatment device to the nasal opening of the sealing layer 3102 and to the patient. Furthermore, as described later in other forms, the sealing layer 3102 can be designed to allow a specific leakage rate, making a separate vent valve or leak valve unnecessary. Therefore, this feature can reduce manufacturing costs by removing the component from the treatment device.

[0354] In some forms, the film layer 3118 can be a meltable material, such as a thermoplastic or thermosetting material. The material is capable of taking shape when melted into a mold or other form, as detailed later in this specification. Figures 7A-7HAs shown, the membrane layer 3118 is molten or partially molten (e.g., tacky), allowing the material to conform to a specific shape. Once the membrane layer 3118 melts, it is allowed to solidify into a shape (e.g., the shape of a mold). Once solidified, the membrane layer 3118 takes on the shape of the mold, giving it a predetermined shape. The membrane layer 3118 imparts the shape of any material laminated or adhered to it. For example, the membrane layer 3118 can give a fabric sheet 3116 the same shape as the membrane layer 3118 because the membrane layer 3118 is fixed to the fabric sheet 3116 and can conform to various shapes. The fabric sheet 3116 may also include features such that it includes molten and then conformable portions. The amount of pressure required to temporarily change the shape of the laminate of the sealing layer 3102 may depend on the thickness of the membrane layer 3118 and the material to which the membrane layer 3118 is formed.

[0355] In some forms of this technology, the film layer 3118 can be formed of a thermosetting material. Additionally, the sealing layer 3102 may include an additional laminate formed of a thermosetting material. An example of a thermosetting material is foam. A laminate containing a thermosetting material can be placed in a mold and then subjected to heat. Thermosetting materials can cure in a manner similar to thermoplastic materials. That is, thermosetting materials can be subjected to heat, and unlike thermoplastic materials, thermosetting materials can be irreversibly cured into a specific shape. Thermosetting materials can be used if a more rigid or permanent structure is required. The flexibility and stiffness of a component (e.g., sealing layer 3102) can be adjusted based on the selected material and the thickness of the thermosetting material. Because thermosetting materials can cure into a specific shape, when used as a laminate containing sealing layer 3102, the shape of sealing layer 3102 can also be formed into a specific shape.

[0356] Reference Figure 4P The sealing layer 3102, together with the base 3104 and the frame 3152, can be integrated into a mask and air delivery system for use in conjunction with treatment. As shown, the base 3104 can be attached to the component connection port 3154. The component connection port 3154 can provide air distribution to the sealing layer 3102 through the tube 3350.

[0357] The sealing layer 3102 can be lighter than other forms of the technology and is more comfortable for the patient compared to other forms of the technology. Furthermore, because fabric sheets, such as fabric sheet 3116, can be stored in a flat or planar manner, the storage cost of the material can be lower than with other forms. Additionally, the use of mold 3112 (see...) Figures 7A-7GThis allows for the formation of complex shapes, such as sealing layer 3102, while reducing costs. Unlike injection molding or extrusion molding, which requires multiple complex parts and machinery, the die-layout process, including molds such as mold 3112, provides a simple process that can reduce manufacturing time and costs. Furthermore, complex shapes can be formed relatively easily.

[0358] Furthermore, in some forms, the membrane layer 3118 used in forming the sealing layer 3102 can be the same material used in forming the fabric conduit, as described later in this detailed description. By using the same material, the production cost of various components can be reduced because large quantities of material can be purchased in bulk.

[0359] See also Figure 4Q The figure depicts a possible assembly of a tube configured to interact with a sealing structure 3100. As shown, an assembly connection port 3154 is secured between the layers of the tube. The assembly connection port 3154 is sandwiched between an inner fabric layer 3452 and an outer fabric layer 3454. Furthermore, the assembly connection port 3154 extends through an outer foam layer 3456. In this configuration, an air passage or air conduit is formed between the inner fabric layer 3452 and the outer fabric layer 3454, such that the assembly connection port 3154 is used to deliver air from the air passage and through the outer foam layer 3456. In this way, the assembly connection port 3154 is secured by the inner fabric layer 3452 and the outer fabric layer 3454. The connection port 3154 can then be snap-fitted, friction-fitted, or otherwise secured to a frame 3152 to supply air to the patient.

[0360] 5.3.2.1 Method for forming a sealing structure

[0361] See also Figures 7A-7J This illustrates one method for forming a sealing structure. Figure 7A In the mold 3112, there is a receiving portion 3114. The receiving portion 3114 may be in the shape of a sealing surface used in conjunction with a full-face, nose, or other mask for use with a treatment device.

[0362] See also Figure 7B and 7C The fabric sheet 3116 is placed on the mold 3112. The fabric sheet 3116 can be formed from materials such as cotton, polyester, rayon, or other materials or combinations thereof. Furthermore, the configuration of the fabric sheet 3116 can also be formed to the same type as the sheets described in detail below, such as the inner layer 3352 and the outer layer 3426. That is, the fabric sheet 3116 can be woven, non-woven, knitted, braided, or any other fiber web. Although in Figures 7A-7HThe fabric film is not shown before being placed in the receiving portion 3114 of the mold 3112, but in other forms, the fabric sheet 3116 may include a fabric film. In a further form, the fabric sheet 3116 may be pre-laminated with, for example, polyurethane or silicone.

[0363] After the fabric sheet 3116 is arranged along the die 3112, the fabric sheet 3116 can be pressed into the appropriate position within the receiving portion 3114. In some forms, rollers may be used to ensure that the fabric sheet 3116 is in the correct position. Figure 7C and 7D The correct position is shown. In other forms, a vacuum seal can be used to pull the fabric sheet 3116 toward the receiving portion 3114. In other forms, another method can be used to press the fabric sheet 3116 into the receiving portion 3114.

[0364] Once the fabric sheet 3116 is in place, such as Figure 7E As shown, the membrane material can be placed along the upper surface of the fabric sheet 3116. The membrane layer 3118 can be a thermoplastic or thermosetting material, silicone, polyurethane, or other materials. The material of the membrane layer 3118 can be sprayed, painted, or spread on the fabric sheet 3116 as depicted, or it can be pre-laminated on the fabric sheet 3116. The membrane layer 3118 can be a resin or other material that is cured or solidified by chemical processes or by exposure to air. As shown, the membrane layer 3118 is a liquid thermosetting material. The membrane layer 3118 is spread along the upper surface covering the surface as required by the manufacturer. In some forms, the entire upper surface of the fabric sheet 3116 may be uncovered. That is, in some cases, portions of the fabric sheet 3116 may remain uncovered to provide easier attachment or fixation to other components. Furthermore, in other forms, the fabric sheet 3116 may be a laminate and already include a surface formed of the membrane material.

[0365] Furthermore, the membrane layer 3118 can be thicker in some areas compared to other areas. The membrane layer 3118 can be applied in liquid form at different rates to provide different thicknesses. Additionally, when the membrane layer 3118 is formed as a separate solid layer, it can be pre-fabricated to have areas (e.g., nasolabial fold junction area 3107) that are thicker than other areas (e.g., flange 3107).

[0366] Reference Figure 7F The membrane layer 3118 and the fabric sheet 3116 may be exposed to heat. If the membrane material has been cured, the heat can melt the membrane layer 3118 and may also allow the membrane layer 3118 to unfold or delaminate uniformly along the fabric sheet 3116. In other forms, the membrane layer 3118 may be allowed to... Figure 7E The steps shown are followed by curing without adding any additional heat to the system.

[0367] After the 3118 film has cured, as Figure 7G As shown, the fabric sheet 3116, along with the cured film layer 3118, is removed from the mold 3112. Even when removed from the receiving portion 3114, the fabric sheet 3116 located within the receiving portion 3114 now takes on the shape of the receiving portion 3114. Because the film layer 3118 is a thermosetting material that can be cured into a specific shape, the sealing layer 3102 also takes on the same shape as the film layer 3118.

[0368] like Figure 7H As shown, the sealing layer 3102 is cut off from the remainder of the fabric sheet 3116. As illustrated, the sealing layer 3102 is cut using scissors or shears; however, in other forms, other techniques or devices, such as die-cutting, may be used to cut the sealing layer 3102. In non-limiting examples, in some forms, a hot cutter may be used to cut the sealing layer 3102. In other forms, a die may be used to cut through the fabric sheet 3116.

[0369] As shown in the picture (see) Figures 6A-6C As shown, the first nostril opening 3108 and the second nostril opening 3110 can be formed within the sealing layer 3102. The first nostril opening 3108 and the second nostril opening 3110 can be formed within the receiving portion 3114. That is, the receiving portion 3114 can be shaped to influence its shape using peaks or valleys. Various shapes of the sealing layer 3102 are possible by changing the shape of the receiving portion 3114. In some forms, the fabric sheet 3116 can be pre-cut along the area of ​​the receiving portion 3114 corresponding to the first nostril opening 3108 and the second nostril opening 3110. In other forms, once cured, the material of the sealing layer 3102 can be removed from the area where the first nostril opening 3108 and the second nostril opening 3110 are located. Furthermore, after removing the sealing layer 3102 from the mold 3112, further post-processing can be performed on the sealing layer 3102.

[0370] In some forms, the fabric sheet 3116 can be pre-cut before being placed on the mold 3112. In this form, the number of folds within the sealing layer 3102 of the sealing forming structure 3100 can be reduced compared to other forms. For example, Figure 7I As shown, fabric sheet 3116 is cut to form pre-cut sheet 3117. Pre-cut sheet 3117 includes various notches 3120. These notches 3120 are specifically designed so that when pre-cut sheet 3117 is placed within mold 3112, the material of pre-cut sheet 3117 can fold without overlapping itself. That is, pre-cut sheet 3117 can form adjacent joints opposite to overlapping seams. This can improve user comfort and tactile feel. For example, as... Figure 7I As shown, a notch 3122 is formed between the first flap 3124 and the second flap 3126 of the pre-cut material 3117. The lengths of the first flap 3124 and the second flap 3126 can be used to determine the height 3111 of the sealing layer 3102.

[0371] Now see Figure 7J After sheet 3117 has been placed in the mold and cured, the first flap 3124 and the second flap 3126 can be folded upwards according to the shape of the mold. When folded, the first flap 3124 and the second flap 3126 can be adjacent to each other in the area of ​​the notch 3122. Based on the geometry of the sealing layer 3102, the shape and size of the notch 3122 can be changed to allow for various designs and configurations. For example... Figure 7J As shown, the first wing 3124 and the second wing 3126 do not overlap each other. However, in other forms, the winglets may be designed to overlap each other to provide increased stiffness in specific areas (e.g., the nasolabial fold junction region 3107).

[0372] like Figure 7I and 7J The configuration shown provides a smooth inner and outer surface for the sealing layer 3102. Furthermore, by cutting the fabric sheet before molding, the amount of time required to arrange the fabric sheet within the mold can be reduced compared to other forms where the fabric sheet can be folded to fit within the mold.

[0373] 5.3.3 Positioning and Stabilizing Structure

[0374] The sealing structures 3100 and 9100 of the patient interfaces 3000, 6000, 7000, 8000, 9000, and 10000 of this technology can be kept in a sealed state during use by positioning and stabilizing structures 3300, 7300, 8300, and 9300. The positioning and stabilizing structures may include, or be referred to as, a "headband" because it engages with the patient's head to hold the patient interface in a sealed position.

[0375] In one configuration, the positioning and stabilizing structure provides a holding force that is at least sufficient to overcome the effects of the positive pressure in the inflation chambers 3200, 9200, to lift the face away.

[0376] In one form, positioning and stabilizing structures provide holding forces to overcome the effects of gravity on the patient interface.

[0377] In one form, the positioning and stabilizing structure provides holding forces as a safety margin to overcome the potential effects of destructive forces acting on the patient interface, such as those from tube resistance or accidental interference with the patient interface.

[0378] In one form of this technology, a positioning and stabilizing structure is provided, configured in a manner consistent with that worn by a patient while sleeping. In one instance, the positioning and stabilizing structure has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one instance, the positioning and stabilizing structure includes at least one strap with a rectangular cross-section. In one instance, the positioning and stabilizing structure includes at least one flat strap.

[0379] In one form of this technology, a positioning and stabilizing structure is provided, configured not to be too large or bulky to prevent the patient from lying in a supine position, wherein the posterior region of the patient's head rests on a pillow.

[0380] The positioning and stabilizing structure may include at least one frenulum. A frenulum will be understood as a structure designed to resist tension. In use, the frenulum is part of the positioning and stabilizing structure under tension. As will be described, some frenulums will exert elasticity due to tension. The frenulum can be used to hold the sealing-forming structure in a therapeutically effective position on the patient's head. In some forms of this technology, the positioning and stabilizing structure may include frenulum in the form of a headband tube and / or headband strap, as will now be described.

[0381] In one form of this technology, the positioning and stabilizing structure includes a first frenulum configured and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over a supraacular acupoint on the patient's head and covers a portion of the parietal bone but not the occipital bone. The first frenulum can be provided as, for example, part of a patient interface, including a support pad, nasal pillow, nasal pad, full-face pad, or oronasal pad. For example, the positioning and stabilizing structure may include a first frenulum in the form of a gas delivery tube located on the top of the patient's head. Gas delivery tubes may also be referred to as headband tubes because they provide the function of a headband.

[0382] In one form of this technology applicable to nasal masks or full-face masks only, the positioning and stabilizing structure includes a second tether configured and arranged such that, in use, at least a portion of the upper edge of the second tether passes beneath a base point below the ear on the patient's head and covers or lies beneath the occipital bone of the patient's head. The second tether can be provided as, for example, part of a patient interface, including a support pad, nasal pillow, full-face pad, nasal pad, or oronasal pad. For example, the positioning and stabilizing structure may include a second tether in the form of a strap abutting against the posterior surface of the patient's head.

[0383] In one form of this technology applicable to nasal masks only, or to full-face masks or oronasal masks, the positioning and stabilizing structure includes a third frenulum configured to anchor against the posterior surface of the patient's neck. Additionally, in some forms, the positioning and stabilizing structure includes a fourth frenulum constructed and arranged to interconnect with the second and third frenulums to reduce the tendency of the second and third frenulums to move away from each other.

[0384] In some forms of this technology, the positioning and stabilizing structure includes a strap that is flexible and, for example, non-rigid. An advantage of this aspect is that the strap makes the patient more comfortable lying on it while sleeping. The positioning and stabilizing structure may include a flexible strap. The strap can be considered a posterior strap. The strap is flexible enough to wrap around the back of the patient's head and rest comfortably against the patient's head, even when under tension during use.

[0385] In some forms of this technology, the positioning and stabilizing structure includes straps configured to be breathable to allow moisture vapor to pass through them.

[0386] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure, each configured to provide a holding force corresponding to a range of sizes and / or shapes. For example, the system may include one form suitable for positioning and stabilizing structures for large-sized heads but not for small-sized heads, and another form suitable for small-sized heads but not for large-sized heads.

[0387] In some forms, the positioning and stabilizing structure may include a gas delivery tube to deliver pressurized breathable gas to the patient’s airway via a mask interface (e.g., a pad module), and may therefore be referred to as a “catheter headband”.

[0388] For example, refer to Figure 4B The patient interface 3000 is illustrated. As shown, the patient interface 3000 includes a gas delivery tube, described as a tube 3350, which extends along the parietal bone above the ear around the patient's head and reaches a sealing structure 3100. The tube 3350 delivers air to the sealing structure 3100 and supports the sealing structure 3100 in place. Thus, the tube 3350 can function as both a support structure and an air conduit. For example, in other forms, a separate tube, such as an air delivery tube 3348, may be attached directly to the sealing structure 3100 and not extend around the patient's head. In this form, the tube is not supported by the patient's head, nor does it provide support for the sealing structure. This form also includes a separate strap for supporting the sealing structure.

[0389] The patient interface 3000 includes a head strap 3420 attached to a tube 3350. The head strap 3420 can be used to support the tube 3350 and help provide proper positioning of the patient interface 3000. The head strap 3420 can provide tension on the tube 3350 so that the tube 3350 does not fall forward or in front of the patient's face during normal use. Additionally, the head strap 3420 can work with the tube 3350 to provide sufficient upward force to the sealing structure 3100 to help hold the sealing structure 3100 in the correct position relative to the patient's face, so that the sealing layer 3102 adequately seals to the patient's air opening. Therefore, the stabilizing structure 3300 may include at least the tube 3350 and the head strap 3420.

[0390] In some configurations, the head strap 3420 can be directly and permanently attached to the tube 3350. That is, removing the head strap 3420 from the tube 3350 will damage one or both the head strap 3420 and the tube 3350. For example... Figure 5A As shown, the head strap 3420 is directly attached to the tube 3350 between the inner and outer layers. In some forms, the head strap 3420 does not require sutures. For example, in some forms, the head strap 3420 is sandwiched between the inner and outer layers of the tube 3350 and this area is heated. The inner and outer layers of the tube 3350 may comprise thermoplastic or thermosetting materials that change upon heating. Thus, when heated, the material may melt or soften, allowing the material to interact with the head strap 3420, and when the material solidifies, the head strap 3420 is secured between the tabs of the tube 3350. In other forms, the head strap 3420 may include removably attached portions, such as hook-and-loop fasteners. In this form, the tube 3350 may include grooves through which the head strap 3420 can pass. The patient can then adjust the fit of the patient interface 3000 by shifting the tabs of the head strap 3420 and securing the strap in place. In other forms, an adjustable cord or rope or line can be used to comfortably fit the patient interface 3000 onto the patient's head.

[0391] As shown in the figure, the sealing structure 3100 extends to the patient's nose while preventing obstruction of the mouth. Some patients may prefer a patient interface that includes a specific type of face mask, such as... Figures 4A-4D As shown, this allows patients to switch between masks while receiving treatment. Depending on need or comfort, other patients may prefer a full-face mask or a mask that covers the mouth. Various forms of this technology can be used depending on the patient's specific purpose. Although described as a nasal mask, a full-face mask can also be used.

[0392] In some forms, the sealing structure includes a base 3104 such that the sealing forming structure 3100 is removably attached to the frame 3152. The base 3104 may include a clip mechanism such that the sealing forming structure 3100 can be attached to the frame 3152 (see [link]). Figure 4P The frame 3152 may include connection points or locations for the connecting tube 3350. Therefore, air can enter the frame 3152, then pass through the sealed structure 3100 and ultimately reach the patient.

[0393] In other forms, different frames can be used. For example, in some forms, the frame may include various slots or attachment points, allowing the frame to interact with straps such as those from the head strap 3432. For example, although in Figure 4A As not shown, the frame may include a forehead support member, which includes grooves for interacting with the straps. Additionally, as... Figure 5F As shown, the lower groove adjacent to a structure such as the sealing forming structure 3100 can be used to interact with the head strap and allow for adjustable fit of the head strap or stabilizing structure 3300.

[0394] In one form of this technology, the positioning and stabilizing structures 3300, 7300, 8300, and 9300 are provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure. The decoupling portion does not resist compression and can be, for example, a flexible or loose bandage. The decoupling portion is constructed and arranged such that when the patient lies on the head pillow, its presence prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure and disrupting the seal.

[0395] In one form of this technology, the positioning and stabilizing structure includes a strap constructed from a laminate of a textile inner layer, a foam inner layer, and a textile outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In another form, the textile outer layer includes a loop material for engagement with a hook material portion.

[0396] In some forms of this technology, the positioning and stabilizing structure includes a strap that is extendable, for example, elastically stretchable. For instance, the strap may be configured during use to withstand tensile forces and guide forces to bring the sealing structure into sealed contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0397] 5.3.3.1 Positioning and stabilizing structure according to the example of this technology

[0398] 5.3.3.1.1 Headband

[0399] exist Figure 4BIn the illustrated form of the present technology, the patient interface 3000 includes at least one tube 3350 that delivers pressurized air from the RPT device to the patient's airway, received from a conduit such as an air delivery tube 3348 forming part of an air circuit 4170. For example, it extends through the inflation chamber 3200 and the sealing formation 3100. The tube 3350 is integral part of the headband 3300 of the patient interface 3000 to position and stabilize the sealing formation 3100 of the patient interface to an appropriate portion of the patient's face (e.g., nose and / or mouth). This allows the air delivery tube 3348, which provides the pressurized airflow, to connect to the connection port 3600 of the patient interface at a location other than in front of the patient's face, which may be unsightly for some individuals.

[0400] Since air can be included and passed 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 airtight or air-retaining. It should be understood that airtight or air-retaining positioning and stabilizing structure 3300 does not require all components of positioning and stabilizing structure 3300 to be airtight.

[0401] 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 4B In the illustrated form of this technology, the connection port 3600 is located at the top of the patient's head during use. It may be advantageous for the patient interface to not have the connection port positioned at the front of the patient's face, as some patients find catheters connected to a front-facing patient interface unsightly and protruding. For example, catheters connected to a front-facing patient interface 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 a patient interface with a 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; supine (i.e., lying on their back with their face up); and prone (i.e., lying face down). Furthermore, connecting the catheter to the front of the patient interface can also cause a problem known as tube drag, where the catheter may provide an undesirable dragging force on the patient interface, causing it to move away from the face.

[0402] exist Figure 4A 、 4B In the -4D example, at least one tube 3350 extends from the connection port 3600 through the patient's cheek area and above the patient's ear between the pad assemblies 3150. That is, a portion of the tube 3350 connected to the pad assembly 3150 covers the maxillary region of the patient's head in use, and a portion of the tube 3350 covers the area of ​​the patient's head above the supraauricular basal point. Additionally, in cases such as... Figure 4A and4B In some forms shown in -4D, the tube 3350 is positioned along both sides of the user's face. That is, for example, the tube 3350 extends through the patient's right cheek area and left cheek area.

[0403] exist Figure 4B In the illustrated form of the technology, the positioning and stabilizing structure 3300 includes a single tube 3350 comprising a right portion and a left portion, each portion being positioned on a different side of the patient's head during use and extending across the corresponding cheek area, 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.

[0404] like Figure 4B As shown, the patient interface has a tube 3350. The single tube 3350 is positioned on one side of the patient's head during use (e.g., across a cheek area), and the head strap 3420 forms part of the positioning and stabilization structure 3300 and is positioned on the other side of the patient's head during use (e.g., across another area) to help secure the patient interface 3000 to the patient's head. As shown, the tube 3350 extends continuously from one side of the pad assembly 3150 to the connection port 3600 and returns to the other side of the pad assembly 3150.

[0405] like Figure 4B As shown, the left arm 3302 and the right arm 3304 are connected to each other in a continuous manner. That is, there is no specific connection point between the left arm 3302 and the right arm 3304. Instead, the fluid connection extends seamlessly between the two arms. By continuously forming the tube 3350, the number of parts of the patient interface 3000 can be reduced compared to other forms of this technology.

[0406] exist Figures 4A-4DIn an exemplary form of the illustrated technology, tube 3350 bends around the upper part of the patient's head from its upper end. Tube 3350 includes a connection port 3600 on the top of the head to a tab 3346, after which a posterior headband strap 3420 connects to tube 3350, with substantially no bend in the coronal plane. Between the tab 3346 of tube 3350 and the lower end of tube 3350, where the posterior headband strap 3420 connects, tube 3350 connects to a pad assembly 3150 located below the nose in front of the patient's airway. Tube 3350 bends forward or apex between the patient's ears and eyes and throughout the cheek area. The radius of curvature of this portion of tube 3350 can be in the range of 60-100 mm, for example 70-90 mm, such as 80 mm. The lower end of tube 3350 and the portion of the headband strap 3420 at the rear of tube 3350 that are connected to tube 3350 can be oriented at an angle within the range of 65-90°, for example, 75-80°.

[0407] exist Figures 4A-4D In an exemplary form of the illustrated technology, tube 3350 extends substantially vertically in the upward direction (i.e., upward) from near the supraaural base point to the connection port 3600. That is, tube 3350 forms an angle between 0 and 15 degrees with the coronal plane in the region between the supraaural base point and the connection port 3600. In other forms, the angle can be larger depending on the patient's positioning. Additionally, tube 3350 is configured such that it has a larger angle relative to the sagittal plane from the patient's supraaural base point to the airway.

[0408] In addition, if Figures 4B-4DAs shown, tube 3350 includes a connection port 3600. The connection port 3600 may be partially located within tube 3350. That is, a portion of the connection port 3600 extends through the outer layer 3354 and is located between the outer layer 3354 and the inner layer 3352 of tube 3350. In this way, the connection port 3600 is sandwiched between the layers of tube 3350. The connection port 3600 may be configured to connect to other tubes, such as the air delivery tube 3348 of a therapeutic device that provides airflow from air circuit 4170. In some forms, the air delivery tube 3348 may form the entire air circuit 4170, while in other forms, the air delivery tube 3348 forms a portion of the air circuit 4170. The air delivery tube 3348 may be formed of various materials, including fabric materials, silicone, and other materials. By integrating the connection port 3600 within tube 3350, the number of seams or connection points along tube 3350 can be reduced compared to other forms of the present technology. Furthermore, by integrating the connection port 3600 within the tube 3350, the use of additional connection mechanisms such as adhesives, fasteners, or other additional mechanism features can be minimized or eliminated. In other forms, the connection port 3600 includes an inner portion and an outer portion. The inner portion may be located between the inner layer 3352 and the outer layer 3354. The outer portion interacts with the inner portion such that the outer layer 3354 is sandwiched between the inner and outer portions of the connection port 3600.

[0409] In some forms, fabric is used to form various components of the stabilizing structure 3300. As shown, tube 3350 is formed from fabric material. Some patients may find the silicone tube uncomfortable when it is against their face. Additionally, patients may experience discomfort even when a fabric cover or sock is placed over the silicone tube. The thickness and weight of the silicone tube may cause patients to discontinue use of the device. Furthermore, the silicone tube may wrinkle or bend when the patient is lying head down, making the thickness of the tube easily felt on the patient's face, even when covered by a fabric cover. Fabric catheters or tubes, such as tube 3350, can increase comfort for some patients.

[0410] Fabric materials can be flat, planar sheets of material, or they can be formed into a three-dimensional configuration, giving them positive or negative curvature. The terms "fabric material" or "fabric" as used in this specification can be used to describe any fiber web. For example, a fabric material or fabric can be woven, nonwoven, knitted, braided, or any other form of fiber web. Different configurations of fabric materials can be used for different properties. For example, a woven configuration can be used for specific transverse and longitudinal strengths, while a knitted structure can be used for flexibility and tensile strength. Furthermore, in some forms, different configurations of fabric materials can be combined to achieve specific properties. Additionally, the density of the material can vary depending on the desired properties. For example, a less dense fiber network can be used if greater tensile strength is required.

[0411] Furthermore, fabrics can be formed from a variety of materials. Fabrics can be made from natural or synthetic materials. Examples of materials that can be used include cotton, rayon, polyester, linen, silk, leather, polyurethane, monofilament or multifilament materials, or any combination of materials among others. Materials can be selected based on feel, texture, stiffness, flexibility, stretch, and other factors. Additionally, fabrics can include both natural and synthetic materials. Natural fibers or yarns, such as cotton, can be used to provide a soft touch and comfortable fit for the patient. Synthetic fibers can be used to provide stiffness or strength, as well as other properties, to specific areas of the fabric.

[0412] In some forms of this technology, different materials can be used within the same fabric material. Different materials can be used to provide specific properties to the fabric components. For example, stretchable fibers, plied yarns, or yarns can be included in the fabric in a specific orientation to provide strength along the longitudinal or first direction. Secondary fibers that are substantially non-stretchable, non-stretchable, or tensile-resistant can be included in the fabric along the transverse or second direction. In this way, the fabric can be an anisotropic material with different properties in different directions to provide support for specific components. For example, a tube can be formed from a fabric material. The fabric material can be formed such that it is configured in a first direction to expand or stretch under pressure. In a second direction different from the first direction, the fabric material can be configured to resist stretching or deformation under pressure or force. For example, a tube can be configured such that the fabric material expands radially under air pressure. This stretching allows the tube to receive or accept air and also allows the tube to comfortably rest against the patient. However, the tube may have a specific longitudinal orientation along the patient's face such that longitudinal stretching of the tube is not desired. By fixing or limiting stretching in the longitudinal direction, the positioning of the tube can be maintained to allow the patient to receive consistent treatment.

[0413] In some forms, the fabric tube may be formed from one or more sheets or layers of fabric material. In some forms, a single sheet may be folded or rolled up and secured to itself along its side edge, such that the tube forms a single seam. In other forms, more than one sheet is used. For example, the fabric tube may be formed with a first side configured to contact the patient. This may be referred to as the inner layer. The fabric tube may also include a second side attached to the inner layer but facing away from the patient; this second side may be referred to as the outer layer. The inner and outer layers may each be secured to each other along their respective edges, such that a channel or passage is formed between these seams of the inner and outer layers. That is, the space between the seams remains unconnected.

[0414] As discussed in this detailed description, each of the inner and outer layers includes an inner surface and an outer surface. The inner surface of the inner layer is the surface facing the outer layer. The inner surface of the outer layer is the surface facing the inner layer. Similarly, the outer surface of the outer layer faces away from the inner layer, and the outer surface of the inner layer faces away from the outer layer. Furthermore, in the form of a single sheet, the inner surface is the inward-facing and self-facing surface of the sheet.

[0415] In some forms, one or more sheets of the tube may include an airtight layer or a fabric membrane. In some forms, the inner surfaces of both layers include a membrane configured to restrict or confine air from the inner surface to the outer surface through the layer. The airtight layer may be a thin layer less than the thickness of these fabric sheets of the inner or outer layer. In other forms, the airtight layer may be greater than the thickness of the fabric sheet of either layer. The airtight layer or fabric membrane or film may be completely impermeable to air transmission, or may be formed to allow a predetermined rate or air transmission and a specific pressure. In a further form, the membrane may be specifically designed to allow a certain amount or quantity of air or water vapor or wet vapor to pass through the fabric, such that the tube 3350 is permeable, allowing moisture to escape and / or be transmitted through it. By removing air through the membrane, the need for a separate vent valve for exhaust gases is eliminated, as air can escape through components such as ducts or sealing structures themselves. Furthermore, in some forms, permeability can be adjusted in specific areas. For example, permeability in the tube 3350 may be varied along the cheek area. This area may become hot during use and cause discomfort to the user. The permeability can be altered to allow some air to pass through tube 3350 to reach the patient's skin, thereby causing a cooling effect. The type and permeability of the membrane can be changed or adjusted depending on the nature or purpose of the fabric on which the membrane is located.

[0416] In some forms, the thickness of the fabric membrane can vary. In some forms of this technology, the fabric membrane can be less than 5% of the fabric thickness. In other forms, the thickness of the fabric membrane can be from 5% to 25% of the fabric thickness. In a further form, the thickness of the fabric membrane can be from 25% to 50% of the fabric thickness. Additionally, the thickness of the fabric membrane can be from 50% to 100% or more of the fabric thickness. Changing the thickness of the fabric membrane affects the stiffness and tensile properties of the fabric. For example, a fabric comprising a fabric membrane of 1% of the fabric thickness may be less stiff and more stretchable than a fabric comprising a fabric membrane of more than 50% of the fabric thickness. In some forms, a thicker fabric membrane can be used to provide additional strength in specific areas of the conduit or sealing interface. That is, the thickness of the fabric membrane can be increased in high-stress areas or areas more likely to experience kinking or folding during use.

[0417] Membranes can be formed from thermoplastic or thermosetting materials, allowing the membrane material to be molded or shaped into a specific form when exposed to a particular temperature, and then cured, solidified, or condensed upon cooling. In some forms, membranes can be formed from silicone or polyurethane.

[0418] Furthermore, in some forms, the membrane material can help bond the seams of these layers together. For example, thermosetting or thermoplastic materials can crosslink, for example, in thermosetting materials or melt, for example, in thermoplastic materials when exposed to a specific heat. When cured, the materials can bond together. For example, a membrane along the inner surface 3356 of the outer layer 3354 and a membrane along the inner surface 3358 of the inner layer 3352 can be heated along the edges of the outer layer 3354 and the inner layer 3352 to form a seam between the two layers.

[0419] The inner layer can be attached to the opposite outer layer along the first and second seams. Once these layers are attached to each other, a tube or conduit can be formed between the two layers. By securing these layers along these edges, a central chamber is formed, which allows air or other gaseous or liquid media to flow when secured with air circuit 4170.

[0420] like Figure 4B The tube 3350 shown is formed using a fabric comprising a membrane. The tube 3350 includes an inner layer 3352 and an opposite outer layer 3354. Both the inner layer 3352 and the outer layer 3354 include an impermeable membrane along the inner surface of these layers. Although described and shown as including only the inner surface coated with the impermeable layer, in some forms, both the inner and outer surfaces of the layers of the tube 3350 may include the impermeable membrane. However, in some forms, the impermeable membrane may be oriented away from the patient's face. By orienting the tube 3350 in this way, the soft touch of the textile can be pressed against the patient, while the impermeable membrane layer is separated from the patient. This allows for the formation of monolithic materials with different properties depending on the sides of the material used. This can reduce production costs and the time required or needed to form the component.

[0421] 5.3.3.1.1.1 Shape and Composition of the Tube

[0422] refer to Figure 4F The cross-section of tube 3350 is depicted. In some forms, the inner layer 3352 and the outer layer 3354 can be formed of multiple layers of fabric material and / or membrane material. Different properties can be achieved by changing the thickness and composition of the layers of tube 3350. For example... Figure 4F ,in particular Figure 4F-1 As shown, the inner layer 3352 includes a fabric sheet 3360 and a fabric membrane 3362. The fabric sheet 3360 can be formed of felt, spacer textiles, foam, woven, knitted, or nonwoven materials or other fiber webs. As shown, the fabric sheet 3360 is a felt-type fabric. In this way, the outer surface 3374 of the inner layer 3352 can have a soft touch against the patient's face. The outer layer 3354 is composed of multiple fabric sheets. The outer layer 3354 includes a tube sheet 3364 and an outer covering layer 3366. In some forms, the sides of the tube sheet 3364 can be covered with a fabric membrane. Figure 4F-2 As shown, tube sheet 3364 includes a fabric membrane 3368 exposed to the chamber of tube 3350 and a fabric membrane 3370 along the opposite surface of tube sheet 3364. Fabric membrane 3368 helps provide a seal between inner layer 3352 and outer layer 3354 and forms an airtight tube. Fabric membrane 3370 helps connect tube sheet 3364 to outer cover layer 3366. In other forms, tube sheet 3364 may be directly bonded or attached to outer cover layer 3366. In other forms, outer layer 3354 includes a thermoformable shape-retaining material or material, such as a foam layer located between tube sheet 3364 and outer cover layer 3366. In other forms, tube sheet 3364 may be thermoformable. As discussed in detail later in this detailed description, shape-retaining material may be used to provide a predetermined shape for tube 3350.

[0423] The configuration, orientation, and composition of the inner layer 3352 and outer layer 3354 sheets can help provide a support structure to the tube 3350 to prevent clogging during use. For example... Figure 4FAs shown, the cross-section of tube 3350 is substantially D-shaped, forming an air passage 3372 between the inner layer 3352 and the outer layer 3354. The inner layer 3352 is substantially planar, giving it zero curvature. The outer layer 3354 curves away from the inner layer 3352, giving its inner surface 3356 a positive curvature between the joints. As shown, the curvature of the inner surface 3356 varies between the joints of tube 3350. That is, the curvature can be negative, adjacent to the position where the inner layer 3352 and the outer layer 3354 are joined. However, it should be recognized that the total curvature is positive when taken from the center point between the connecting edges of tube 3350. In other words, the outer layer 3354 has a non-planar configuration that forms an arcuate portion in cross-section between the connecting edges. That is, the inner surface 3356 of the outer layer 3354 can have a concave shape and the outer surface 3376 of the outer layer can have a convex shape. The curvature of the outer layer 3354 can be fixed such that when the outer layer 3354 is not subjected to force (e.g., the weight of an external force or air pressure), the inner surface 3356 of the outer layer 3354 has a substantially positive curvature. Therefore, the inner layer 3352 and the outer layer 3354 are asymmetrical, which is the opposite of some conventional conduit portions that have the same or symmetrical shape.

[0424] Furthermore, the cross-sections of the inner surfaces of the inner layer 3352 and the outer layer 3354 can be D-shaped. That is, the inner surfaces can define D-shaped air passages 3372. Therefore, in some forms, the inner surfaces of the inner layer 3352 and the outer layer 3354 can be D-shaped in cross-section, and the outer surfaces of the inner layer 3352 and the outer layer 3354 can also be D-shaped in cross-section.

[0425] In another way, the outer layer 3354 can bend away from the inner layer 3352. For example... Figure 4F As shown, the outer layer 3354 and the inner layer 3352 are attached to each other along their longitudinal edges, such that the edges of the inner layer 3352 and the outer layer 3354 are flush with each other. Between these attachment points, adhesion areas, or joints, the outer layer 3354 bends away from the inner layer 3352. That is, between joints 3312 (see...) Figure 4H The inner surface 3356 of the outer layer 3354 is located away from the inner surface 3358 of the inner layer 3352. In some forms, the outer layer 3354 can be pre-formed such that, in an unpressurized or unsupported state, the outer layer 3354 is pre-positioned and pre-formed to extend away from the inner layer 3352 between the opposing joints 3312. That is, the outer layer 3354 can support its own weight such that, when not supported by pressurized air or other support mechanisms, the outer layer 3354 remains spaced apart from the inner layer 3352 between the joints 3312.

[0426] The roughly D-shaped cross-section can vary along its length; for example, a high, thin D-shaped cross-section near the patient's nose, and a wide, shallow D-shaped cross-section along the cheeks and near the top of the patient's head. Figure 4I-4K Various cross-sections of a pipe 3350 along its length are shown according to one form. As shown, the D-shape of the cross-section varies along its length. Specifically, each cross-section has a width w and a height h, and the width and height of the various cross-sections vary along the length of the pipe, for example, a relatively long width and short height at the manifold end compared to a relatively short width and high height at the interface structure end. In some forms, the D-shaped cross-section of the pipe 3350 may be asymmetrical along the entire length of the pipe or at least along one or more portions of the pipe. Furthermore, all cross-sections have very similar or common hydraulic diameters, for example, about 10-15 mm or about 13 mm. Additionally, the width and height may refer to the chamber dimensions, rather than the total dimensions of the cross-section including the external joint area.

[0427] Furthermore, tube 3350 can provide flatter areas in certain regions, such as areas where the patient rests on the tube during sleep. In this way, the tube can be described as an organic extension of the patient's facial contours. The shape can be configured based on aesthetic and / or impedance requirements. Additionally, the shape can be configured to provide smaller sides, comfort, and / or stability. However, tube 3350 can have other suitable cross-sectional shapes, such as trapezoidal, semi-circular, cylindrical, oval, elliptical, flatter cross-sections, etc. Furthermore, the tube can have a flat configuration with anti-compression ribs. This arrangement is disclosed in U.S. Patent 10 / 385,701, the entire contents of which are incorporated herein by reference.

[0428] In addition, if Figures 4L-1 to 4L-4 The tube 3350 shown can be flexible, allowing it to be easily deformed under finger pressure. That is, the tube 3350 does not need to be formed from a rigid, non-deformable structure. Instead, the tube 3350 is formed such that it can deform under finger pressure. However, the tube 3350 can maintain its shape even without air pressure or other forces.

[0429] Additionally, the outer layer 3354 can be a resilient structure. During normal use, the outer layer 3354 can deform under pressure or force to accommodate the patient's movements during sleep and use. For example, the tube 3350 can collapse, causing the outer layer 3354 to press against the inner layer 3352 not only at the sealing edges but also between the sealing edges. However, when the force is removed from the outer layer 3354, it can return to its predetermined shape, including its inner surface with positive curvature. That is, the outer layer 3354 is not a soft structure because it is able to support its own weight without changing its shape (e.g., by bending or torsion). The outer layer 3354 can have a hardness between 0010 and 0030 on the Shore A scale. In other forms, the outer layer 3354 can be stiffer, allowing it to resist greater forces.

[0430] The outer layer 3354 may include a material resistant to plastic deformation. For example, the outer layer 3354 may be bent or folded such that when subjected to force, a portion of the outer surface 3376 can abut against itself. However, once the force is released, the outer layer 3354 returns to its pre-stressed shape. The outer layer 3354 elastically deforms and returns to its predetermined shape, rather than undergoing plastic deformation or failure. Furthermore, a large portion of the tube 3350 is capable of being bent, folded, or twisted in a similar manner. That is, the tube 3350 may be formed of a material that does not plastically deform when folded onto itself.

[0431] Conversely, the inner layer 3352 can be a flexible component. The inner layer 3352 can be attached and secured to the edge of the outer layer 3354, making the inner layer 3352 a substantially planar layer. The shape of the inner layer 3352 can be influenced by the shape of the outer layer 3354. As shown, the inner layer 3352 can be planar due to the force applied to it through the seam of the tube 3350. Because the outer layer 3354 resists deformation, it can maintain the tightness of the inner layer 3352, making the inner layer 3352 planar. In other forms, the inner layer 3352 can be cut so that it is wider than the outer layer 3354; however, the inner layer 3352 still connects to the outer layer 3354 along the edge of the tube 3350. In this form, the unsecured portion of the inner layer 3352 can move inward toward the outer layer 3354.

[0432] In some forms, the inner layer 3352 may be flexible in some areas and rigid in others. For example, in some forms, a stiffener may be used within the arm support 3314 to give the inner layer 3352 stiffness, so that the inner layer 3352 is not flexible in certain areas. However, in some forms, the inner layer 3352 may remain flexible between the seals of the tube 3350. That is, no additional stiffener is used between the seals or joints of the tube 3350. The stiffener may have a Shore hardness between A30 and A90 or higher.

[0433] In other forms, the inner layer 3352 may be at least semi-elastic. That is, although the inner layer 3352 may not be able to support its own weight, it may be able to support some of its own weight with the help of the outer layer 3354, such that the inner layer 3352 is in substantially the same position when not subjected to additional forces (such as air pressure or other external forces).

[0434] The depicted inner layer 3352 is relatively flat and adapts to fit substantially flush against the patient's face during use. The inner layer 3352 may have a tapered configuration from the inner edge to the outer edge to provide a comfortable fit for a wide range of patients. The inner layer 3352 provides a relatively large surface area, resulting in a more uniform load distribution. This arrangement is less likely to create pressure points during use. Furthermore, the inner layer 3352 may have a gripping material to help stabilize the patient interface against the patient's face.

[0435] In some forms, the outer layer 3354 may be more resilient than the inner layer 3352. That is, the outer layer 3354 may resist deformation more than the inner layer 3352. Furthermore, the outer layer 3354 may return to its predetermined shape more easily than the inner layer 3352. Additionally, in some forms, the outer layer 3354 may be harder or more rigid than the inner layer 3352. For example... Figures 4F to 4F-2 As shown, the outer layer 3354 may include more layers than the inner layer 3352, and the outer layer 3354 may have a greater thickness than the inner layer 3352. This configuration of the outer layer 3354 and the inner layer 3352 can help provide a relatively stiffer or more rigid outer layer 3354. Increased stiffness, rigidity, and / or elasticity can help maintain an open passage through which air can travel. Furthermore, in some forms, the outer layer 3354 may include a material that is stiffer than the inner layer 3352. Material compositions can contribute to providing a stiffer or more rigid outer layer 3354.

[0436] The outer layer 3354 has a smooth contour that blends with the patient's face. That is, the outer layer 3354 has a side or organic form whose edges blend tangentially into the patient's face to prevent any edges from getting caught on bedding, pillows, etc., during sleep (e.g., when the patient turns over). As shown, the tube 3350 has a non-cylindrical cross-sectional shape that provides a blending contour to integrate with the patient's face (see Figure 1). Figures 4A-4D The fusion contour is smooth, streamlined, and seamless, blending or tapering the tube 3350 to the contour of the patient's head, for example, being anatomically consistent, less prominent, and more aesthetically pleasing. Furthermore, the fusion contour has no sharp edges that could cause discomfort (e.g., skin irritation or friction).

[0437] In some forms, the outer layer 3354 can be thermoformed, causing the material within the outer layer 3354 to take the shape of a mold or mandrel. Upon curing or cooling, the thermoformed material exhibits the following characteristics: Figure 4F The shape is shown. In some forms, an additional layer may be located between the outer cover layer 3366 and the tube sheet 3364. In some forms, the additional material may be foam or other thermosetting material. In other forms, the tube sheet 3364 or the outer cover layer 3366, or both, may be formed of foam or thermosetting material. In other forms, thermoplastic material may be used. In other forms, any other shape-holding material may be used. As shown, the cross-sectional shape of the tube 3350 can be maintained outside the sheets of the outer layer 3354 and the inner layer 3352 without additional reinforcements or components. Furthermore, the thickness of the inner layer 3352 may be substantially the same along the width of the inner layer 3352. Furthermore, the outer layer 3354 may also have a substantially the same thickness along the width of the outer layer 3354. When thermoformed, the outer layer 3354 is able to maintain its predetermined shape without the assistance of the inner layer 3352. That is, the outer layer 3354 is able to maintain its predetermined shape without tension, force, or support from the inner layer 3352.

[0438] Steering Figure 4R The patient interface 6000 may include an exhaust port formed in the tube 3350 (e.g., in the outer layer 3354) to vent exhaust gas to the atmosphere. In the illustrated example, the exhaust port 6100 is formed near the pad assembly 3150. Additionally, the air delivery tube 6348 may have a fabric construction. For example, the air delivery tube 6348 may have a construction similar to or the same as any tube embodiment disclosed herein.

[0439] See also Figure 4S The patient interface 7000 includes a positioning and stabilizing structure 7300. The positioning and stabilizing structure 7300 includes a tube 7350 having a left arm 7302 and a right arm 7304. The left and right arms may be separate structures with connectors at their upper and lower ends, allowing these arms to be individually and removably connected to both the pad assembly 3150 and the bushing 7200. For example, an upper connector 7312 and a lower connector 7314 are provided at the upper and lower ends of the left and right arms 7302 and 7304, respectively. Figure 4T and 4U As shown. The upper connectors 7312 are configured for removable connection to the bushing, while the lower connectors 7314 are configured for removable connection to the pad assembly 3150.

[0440] See also Figure 4T and 4UEach of the upper connector 7312 and lower connector 7314 in these examples may include a connector body 7303, a slot 7309, a chamfered edge 7308, and a notch 7306, which can be removably attached to clips in the pad assembly 3150 and bushing 7200 in a snap-fit ​​manner. In an alternative embodiment, connectors 7312, 7314 may be disposed in the pad assembly 3150 and / or bushing 7200 and receiving portions may be disposed on the left and right arms 7302, 7304.

[0441] like Figure 4S As shown, the bend 7220 is rotatably connected to the bushing 7200 and includes a swivel connector at its opposite end for connection to an air delivery supply pipe.

[0442] Steering Figure 4V A cross-sectional view of tube 7350 is shown. Similar to outer layer 3354, outer layer 7354 can be configured to support its own weight. As can be seen, outer layer 7354 includes an outer cover layer 7402, which forms the outer surface of the outer layer positioned away from the patient's face during use. An outer cushioning layer 7406 (e.g., foam material) is positioned between outer cover layer 7402 and fabric member 7410, the fabric member forming an airtight surface for air passage. Outer cushioning layer 7406 can be thermoformed to maintain its shape. Adhesive layers 7404 and 7408 may be disposed between outer cover layer 7402 and outer cushioning layer 7406, and between outer cushioning layer 7406 and fabric membrane 7410, respectively. Figure 4W In the alternative example shown, the outer buffer layer 7406 and the adhesive layer 7408 can be removed.

[0443] Return to Figure 4V The inner layer 7352 includes a fabric sheet 7222 configured to engage with a patient's face in use. An inner cushioning layer 7426 (e.g., foam material) is provided between the fabric sheet 7222 and a fabric member 7230 forming an airtight surface for air passage. Adhesive layers 7224 and 7228 may be provided between the fabric sheet 7222 and the inner cushioning layer 7226, and between the inner cushioning layer 7226 and the fabric membrane 7230, respectively.

[0444] Steering Figure 4XThe patient interface 8000 includes a positioning and stabilizing structure 8300 with a tube 8350. The left arm 8302 and the right arm 8304 may each have a lower portion 8362 and an upper portion 8364 that can have different stiffnesses. For example, the lower portion 8362 may be more rigid than the upper portion 8364, or vice versa. This can be achieved, for example, by configuring the inner layer 3352 of the lower portion 8362 to have a different stiffness than the inner layer 3352 of the upper portion 8364 and / or configuring the outer layer 3354 of the lower portion 8362 to have a different stiffness than the outer layer 3354 of the upper portion 8364. Note that each of the left and right arms may have three segments with different properties (e.g., stiffness), rather than just the lower and upper portions.

[0445] In the illustrated example, the inner layer 3352 and outer layer 3354 of the lower portion 8362 are more rigid than the inner layer 3352 and outer layer 3354 of the upper portion 8364, respectively. This makes the upper portion 8364 more flexible and better able to conform to the curvature along the side of the patient's face up to the top of the patient's head. A tab 3346 may be provided on the lower portion 8362, which allows for better connection to the strap 3420, as the increased stiffness of the lower portion helps resist torsion and maintain the desired application of vector forces. Alternatively, the tab 3346 may be provided on the upper portion 8364 or bridge the upper portion 8364 and the lower portion 8362.

[0446] In some forms, the cross-sectional shape of the tube can be specifically formed. For example, in some forms, the tube can be pre-formed to have a flat or planar contact surface and a convex outer layer. The shape of the catheter can be formed to provide a specific tactile feel and to regulate the amount or quantity of oxygen or air compressed to the patient through the tube 3350. That is, the catheter can be formed to limit the degree to which the catheter stretches or expands when subjected to an air or oxygen source. Furthermore, the cross-sectional shape of the tube 3350 can vary along the length of the tube 3350. For example, the cross-sectional shape of the tube 3350 can be different at the adjacent connection port 3600 compared to the adjacent pad assembly 3150. The cross-sectional shape and volume covered by a particular shape can be varied or altered depending on how the patient interface 3000 is configured to interact with the patient. For example, the end of the left arm 3302 can have a smaller cross-section than the connection point between the left arm 3302 and the connection port 3600. Because the end of the left arm 3302 is more likely to be associated with sensitive parts of the patient's face, limiting the cross-sectional dimensions of the end of the left arm 3302 can increase patient comfort compared to other forms of this technology.

[0447] Furthermore, changing the width of the inner or outer layer allows for alteration or diversification of the chamber dimensions. For example, a portion of the inner layer 3352 that forms part of the air passage 3372 may have a width W1 at a first position on the left arm 3302, such as... Figure 4C and Figure 4GAs shown. When connected together, the inner layer 3352 and the outer layer 3354 form a cavity or chamber associated with the air passage 3372, having a cross-sectional area and volume V1. Figure 4H As shown, the inner layer 3352 and the outer layer 3354 may also have a width W2 spaced apart from the width W1 along the left arm 3302. The width W2 can be greater than the width W1. Furthermore, as shown, the cavity formed in region W2 has a volume V2 greater than the volume V1. Therefore, when breathable air passes through the region of width W2, the cross-sectional area of ​​the tube 3350 at the location of width W2 is greater than the cross-sectional area of ​​the tube 3350 at the location of width W1. Moreover, at the location with the second width W2, the volume of the chamber can be greater than the volume at the first width.

[0448] The width can be varied to provide various properties or functions. In some forms, changing the volume of air or oxygen at a specific point can be used to alter the flow rate through different sections of the fabric conduit. For example, if the fabric conduit has a large cross-sectional area at a first location, the breathable air passing through it can flow at a first velocity. If the fabric conduit also has a smaller cross-sectional area at a second location, the breathable air passing through it at that second location can flow at a second velocity greater than the first velocity. Therefore, the conduit's volumetric dimensions can be altered to accelerate or decelerate the airflow through it.

[0449] In some forms, the chamber size of a fabric catheter can be varied by altering the shape of the fabric layers and / or changing the width of the connections or joints of the fabric tube or conduit. A joint is the area where one layer of the tube connects to another, or in some forms, when the tube is formed from a single layer, the area where one layer attaches to itself. For example, as... Figure 4G As shown, connector 3312 is where a layer, such as the inner layer 3352, connects to the lower layer 3354. Changing the width of connector 3312 alters the size of the chamber formed within the fabric catheter. For example, a wider connector reduces the chamber volume compared to a narrower connector. The width of the connector can be different on either side of the fabric catheter. Furthermore, the width of the connector can also vary along the length of the fabric catheter.

[0450] Changing the width of the connector 3312 allows the stiffness of the fabric conduit to vary along its length. For example, in locations potentially subject to higher stress or greater bending potential, the connector width can be greater than in areas not having the same bending potential. The width of the connector 3312 can depend on the width of the welding or cutting mechanism used to form the tube 3350. In other forms, a separate heating mechanism can also be used to join these layers together. In this case, the heating mechanism can be moved to form a wider or narrower connector 3312. Although shown along the outside of the tube 3350, in some forms, the tube 3350 can be flipped inwards to the outside, such that the connector is located within the cavity of the tube 3350.

[0451] In some configurations, the position of the connector 3312 around the D-shaped cross-section of the tube 3350 can be changed to adjust the flexibility and stiffness of the tube along its length.

[0452] In some forms, the joint can be formed using various techniques that impart specific properties to the joint. For example, in some forms, ultrasonic welding, radio frequency welding, and cutting and welding techniques are used to form the joint. Heat can be applied to specific areas of the thermosetting or thermoplastic material used in the activated tube 3350. Heat can be used not only to join the layers together but also to thermoform layers such as the outer layer 3354. Furthermore, in some forms, stitching or adhesives such as glue can be used to join these layers together. In some forms, stitching is not used. In a further form, the material located outside the layers is not used to connect the inner and outer layers of the tube 3350. For example, in some forms, the inner and outer layers can be formed such that additional materials such as glue or stitching are not required to join the inner and outer layers together.

[0453] In some forms, a sleeve (e.g., made of fabric) can cover the tube 3350 to replicate the traces of bedding.

[0454] 5.3.3.1.1.2 Shape of the patient interface

[0455] The tube 3350 can also have various curvatures along its length to correspond to the shape of the patient's face. As previously discussed, the cross-section of the tube 3350 can have a specific shape. The shape of the tube 3350 can vary along its length (not just its width, such as...). Figure 4F(As shown in the diagram). For example, the inner surface 3358 of the inner layer 3352 may have a generally positive curvature along the length of the inner layer 3352. The curvature may be included in the tube 3350 to correspond to the generally negative curvature of the patient's face along the area of ​​the tube 3350 that contacts the patient's head. It should be recognized that the curvature of the patient's face is complex and variable; however, generally, at the point where the tube 3350 contacts the patient's head, the head is typically negatively curved. Furthermore, the curvature can be achieved even when the user is not wearing the headband 3300. That is, the curvature along the length of the tube 3350 may correspond to a predetermined non-planar configuration.

[0456] refer to Figures 4L-1 to 4L-4 The tube 3350 is shown separately. As shown, the tube 3350 is bent or formed in three dimensions such that the inner layer 3352 and the outer layer 3354 are located around various planes. For example, the outermost portion 3378 of the outer layer 3354 adjacent to the connection port 3600 extends along the XY plane. Conversely, the outermost portion 3380 of the outer layer 3354 of the right arm 3304 is positioned along the YZ plane. Furthermore, in some forms, the tube 3350 may include additional bends such that the right arm 3304 rotates along the Z-axis, such that a portion of the outermost portion 3380 extends along the XZ plane. In this way, the tube 3350 can have a predetermined three-dimensional shape.

[0457] exist Figure 4L-2 to 4L-4 The document depicts detailed views of several parts of pipe 3350. Specifically, Figure 4L-2 A side view of a portion of tube 3350 is depicted. Figure 4L-3 This is a front view of a part of tube 3350. Figure 4L-4 This is a top view of a portion of tube 3350.

[0458] Based on the geometry of tube 3350, tube 3350 can be made more rigid in certain areas. For example... Figure 4L-1 As shown, bending or twisting the tube 3350 around various axes may require different levels of force. That is, the tube 3350 may resist deformation or bending along a plane or axis to a greater extent in the first region than in the second region. For example, twisting or bending the tube 3350 along the XY plane may require a different level of force in the first region 3308 adjacent to the connection port 3600 compared to the second region 3310 of the right arm 3304. By arranging the tube 3350 in a specific direction, the strength of the cross-sectional shape of the tube 3350 can be used to resist bending in that direction to help provide a safe patient interface 3000.

[0459] In addition, if Figure 4L-1The tube 3350 shown can be bent or oriented at different angles. For example, the left arm 3302 and right arm 3304 can be oriented closer to each other than depicted. That is, the distance between the left arm 3302 and right arm 3304 along the X-axis can be smaller. The distance between these arms can be modified during the manufacturing process of the tube 3350 according to the desired specific shape. Furthermore, in some forms, the shape of the tube 3350 can be configured to align with or conform to the patient's face. The tube 3350 can have a shape complementary to the patient's. For example, a portion of the patient's face has a negative curvature. The outer surface 3374 of the inner layer 3352 can be configured to have a opposite positive curvature, such that the inner layer 3352 rests flush against the user's face. Additionally, in other areas, the patient's face has a positive curvature. The outer surface 3374 of the inner layer 3352 can be configured to have a opposite negative curvature, such that the inner layer 3352 rests against the user's face. The tube 3350 can be formed with an inward curve at the arms, such that the tube 3350 provides compression to the user's face. That is, in some configurations, the left arm 3302 and the right arm 3304 may be oriented at an angle relative to these planes. The left arm 3302 may lie in the plane, which, if extended, intersects the plane containing the right arm 3304. This orientation provides compression against the user's head to help provide a comfortable and shape-fitting placement.

[0460] In some forms, the left arm 3302 and the right arm 3304 may have accordion-shaped portions to increase the flexibility of the left and right arms, thereby allowing these arms to bend to conform to the patient's face.

[0461] In some forms, the tube shape can be specifically formed. The top view shape of the conduit can vary. Unlike silicone tubes, fabric tubes can be cut and shaped to produce a specific shape, rather than being formed entirely by molding such as injection molding. This ability to determine a specific shape without complex molds allows for lower manufacturing costs compared to other forms.

[0462] In some forms, these layers can be knitted in a specific way to form a layered knit shape. In other forms, the woven, nonwoven, or other fabric of the fiber web can be cut into shapes. In some forms, L-shaped conduits can be formed. In other forms, for example... Figure 4E As shown, a U-shaped tube 3350 can be formed. Various other shapes and configurations can be formed by creating an air delivery system from fabric materials. Furthermore, working with flat or planar sheets facilitates manufacturing and assembly. Because the material can be processed in two-dimensional space, the complexity of joints, connectors, or bends is reduced. Although for ease of observation... Figure 4E It is shown in two dimensions, but in other forms, such as in Figures 4A-4DAs shown, tube 3350 can also be bent or twisted during manufacturing, so that tube 3350 has a predetermined three-dimensional shape.

[0463] In some forms, multiple layers can be combined to form a tube. Compared to other forms, forming a tube with multiple separate sheets allows for the easy creation of complex designs and specific shapes. For example, a shape can be simply cut from two-dimensional layers, rather than forming a three-dimensional tube. Further processing can then be applied to the layers to create a three-dimensional shape. By initially forming or designing the shape in two dimensions, the processing can be simpler, less time-consuming, and more economical than other forms.

[0464] In addition to maintaining its shape without pressure or force, the patient interface 3000 can be configured to be elastically molded. The patient interface 3000 can be located within the packaging before the patient opens and uses it. Some existing patient interfaces are difficult to orient for wearing on a patient's head. The straps of some interfaces are tangled, making it unclear how to properly wear the patient interface. However, the patient interface 3000 is shaped such that when removed from packaging, luggage, or any confined space, it will spring back to its predetermined shape. That is, without additional effort from the user, the patient interface 3000 will orient its arms so that how the patient interface 3000 is worn is obvious to the patient, without requiring additional untying or rearranging of its components. This configuration allows the patient to easily utilize the patient interface 3000.

[0465] 5.3.3.1.1.3 Structural Support Components

[0466] In some forms, the connector can serve as a seal for tube 3350 and as a reinforcement or support structure for tube 3350. Arm support 3314 is a wider connector that can be used specifically to guide the force vector and provide a seal between seal-forming structure 3100 and the patient's airway. Arm support 3314 is resistant to bending, allowing sufficient force to be supplied backward and upward through tube 3350 to pad assembly 3150 to provide a seal between seal-forming structure 3100 and the patient's airway. Reference Figures 4A-4DThe stabilizing structure 3300 includes an arm support 3314. As shown, the arm support 3314 extends along a portion of the left arm 3302. An arm support may also be included along a portion of the right arm 3304. The arm support 3314 resists bending of the left arm 3302, ensuring that the sealing formation structure 3100 maintains proper positioning relative to the user's face or nose when the patient wears the patient interface 3000. For example, when worn, the headband 3300 may tend to straighten between the patient's ear base and the patient's airway. That is, the headband 3300 may tend to straighten where the tube 3350 bends toward the pad assembly 3150. The arm support 3314 prevents the left arm 3302 from rotating about the X-axis. As shown, the arm support 3314 is formed of an inner layer 3352 and an outer layer 3354. That is, no additional material or components are used in the arm support 3314, such that the arm support 3314 is formed only of the material and layers used to form the tube 3350. In this way, the stabilizing structure 3300 can be formed efficiently without the need for additional components. Furthermore, separate reinforcements beyond the inner layer 3352 and outer layer 3354 can be included in various portions of the tube 3350, for example, within the arm support 3314 or along the outer surface of the arm support 3314. In other forms of this technology, separate reinforcements are used to provide stiffness to the tube 3350. One form of the rigidification element according to this technology is preferably thin and conformable when a patient lies on it, but has sufficient rigidity to resist out-of-face bending. That is, the rigidification element is configured to allow bending in some planes and resist bending in others, for example, allowing bending toward and away from the patient's face. The rigidification element also makes the tube 3350 non-stretchable or non-stretchable in the area where the rigidification element is used, resulting in high tensile strength and maintaining its dimensions. The rigidification element can be located within the airflow path of the tube 3350 or can be located outside the tube 3350.

[0467] Furthermore, the reinforcement can correspond to a component with greater hardness and / or stiffness than the surrounding material. Additionally, the reinforcement is used to resist finger deformation. Furthermore, the reinforcement can refer to a component other than the layers forming the inner layer 3352 and the outer layer 3354. For example, a specific area of ​​the tube 3350 may include additional components besides the materials used to form the inner layer 3352 and the outer layer 3354. In some forms, the connection port 3600 (see...) Figure 4M and 4N This can be considered a reinforcement. The connection port 3600 can be formed of a material harder than the surrounding material, and the connection portion 3600 can resist finger deformation. In other forms, the reinforcement can refer to material permanently attached to the inner layer 3352 or the outer layer 3354, other than the inner layer 3352 and the outer layer 3354. Furthermore, the hardener can increase the stiffness of the layer in contact with the hardener compared to a material layer without a reinforcement.

[0468] In one form, rigidifying elements can provide structural integrity or a self-holding form for the patient interface, allowing it to maintain its shape and avoid clumping, for example, shape memory, whether the patient interface is on or off the patient's head. Shape-holding arrangements maintain these tubes in the desired position and facilitate the wearing of the patient interface during use.

[0469] In some forms, rigidifying elements can be used in specific locations. For example, rigidifying elements can be used between layers of the stabilizing structure 3300. For instance, a rigidifying element can be located between the inner layer 3352 and the outer layer 3354. In other forms, rigidifying elements can be located between the various sheets forming the inner layer 3352 and the outer layer 3354. In other forms, rigidifying elements can be positioned along the inner or outer surface of the stabilizing structure 3300. In yet another form, for example, when the head strap 3420 interacts with the tube 3350, the rigidifying element can be located in a high-stress area. Rigidifying elements can be used to provide stiffness to the overall shape of the patient interface 3000 and to provide support for the cross-section of the tube 3350, thereby resisting collapse of the tube 3350.

[0470] In some forms, the rigidifying element may be positioned along the outer surface of the headband 3300. For example, the rigidifying element may be positioned at the location of the arm support 3314 along the outer surface 3376 of the outer layer 3354. In some forms, there is no reinforcing element within the cavity of the tube 3350 between the connection port 3600 and the component connection ports 3154 and 3155. In other forms, there is no reinforcing element between the connection port 3600 and the component connection ports 3154 and 3155, and between the joint of the inner layer 3352 and the outer layer 3354. In a further form, there is no reinforcing element contacting the inner layer 3352 between the connection port 3600 and the component connection ports 3154 and 3155.

[0471] In other forms, the structure and orientation of the inner layer 3352 can allow bending in some directions and have sufficient rigidity to resist bending in others. That is, the inner layer 3352 can be configured to allow bending in some planes and resist bending in others, for example, allowing bending toward and away from the patient's face to conform to the patient's head and resisting bending along planes extending along the inner layer 3352. Therefore, a first plane in which the inner layer 3352 is configured to bend can be perpendicular to a second plane in which the inner layer 3352 resists bending. The outer layer 3354 can also allow bending and resist bending, similar to the inner layer 3352.

[0472] As described above, connector 3312 can form a reinforcement. Connector 3312 can be configured such that tube 3350 allows bending in some planes and resists bending in other planes, for example, allowing bending in a first plane toward and away from the patient's face to conform to the patient's head and resisting bending along a second plane extending therein along the inner layer 3352. Furthermore, connector 3312 can be configured to be substantially rigid in order to resist bending in the first and / or second planes.

[0473] In other forms, the dimensions of the conduit can contribute to resistance to bending. For example, in some forms, the conduit may have a smaller cross-section in a first region. In the first region, for example, a region with a width W1, there is a greater material density compared to the volume or space that the first region may comprise. By increasing the material density at a given location, the strength or stiffness or resistance to bending or deformation perpendicular to the outer layer 3354 in that particular region can be increased compared to other regions. Specific regions that can withstand increased forces (e.g., bending or kinking) may be specifically shaped such that specific materials are used to resist bending or kinking. For example, as shown, the tube 3350 is narrower at end 3306. End 3306 may be connected to the pad assembly 3150. The mask region is more likely to be exposed to bending and kinking. Therefore, by changing the material density at the mask connection location, the likelihood of kinking and bending within the tube 3350 can be reduced.

[0474] 5.3.3.1.1.4 Properties of the Pipeline

[0475] In some forms, the inner layer 3352 and the outer layer 3354 are formed of different materials. In some forms, the inner layer 3352 may be formed of a softer or gentler fabric material than the outer layer 3354. Because the inner layer 3352 is exposed to the patient's skin, the material of the inner layer 3352 can be formed to be particularly comfortable to the touch along the patient's skin. The outer layer 3354 may be made of a different material than the inner layer. The outer layer 3354 is more likely to be caught by abrasive materials or rub against objects. Therefore, in some forms, the outer layer 3354 is formed of a durable material that may not be as soft as the inner layer. Furthermore, the outer surface 3376 of the outer layer 3354 and the outer surface 3374 of the inner layer 3352 may have different surface properties than the inner surfaces of the corresponding layers. Additionally, the outer surface 3374 may have a higher coefficient of friction than the outer surface 3376 of the outer layer 3354 to maintain the positioning of the patient's face and stabilize the position of the structure.

[0476] In some forms, specific surfaces can be layered with membranes. For example, in some forms, only the interior of the catheter or sealing structure includes a membrane. Therefore, the outer and inner surfaces can have different properties. The outer surface can be softer and more breathable and can be made of cotton. This surface can be more comfortable or pleasant for the patient than silicone or polyurethane surfaces. However, the inner surface can be laminated or coated with a membrane. Therefore, the membrane surface can be separated from or isolated from the patient's skin. By using different material properties on the inner or outer surfaces of the fabric catheter, the comfort of specific components can be improved.

[0477] Additionally, the outer surface 3376 may consist only of a fabric surface. That is, the outer surface 3376 may not be covered or laminated with a fabric membrane. In some forms, depending on the design of the particular tube, the outer surface of a particular sheet may or may not be laminated with a fabric membrane. For example, the outer surface 3374 of the inner layer 3352 may not be covered or lined with a fabric membrane to provide a comfortable surface for the patient. However, the outer surface 3376 of the outer layer 3354 may include a membrane for increasing protection or resistance to abrasion or other external forces. Furthermore, because the outer layer 3354 is spaced apart from the patient's skin, it may not be necessary to form an outer layer 3354 with different surface properties along the inner surface 3356 and the outer surface 3376. For example, the outer layer 3354 may be immersed in a thermoplastic or thermosetting material such that both surfaces are covered with a fabric membrane. In this configuration, the manufacturing cost of the outer layer 3354 can be reduced because the time required to immerse the outer layer 3354 can be less than the time required to laminate the surfaces of the layers.

[0478] The total weight of the positioning and stabilizing structure is preferably less than 50g (e.g., less than 40g or less than 30g). Each of the inner layer 3352 and the outer layer 3354 may have a thickness of less than 2mm (e.g., less than 1mm).

[0479] By using fabric sheets, colors can be easily customized. For example, one sheet can be blue, while another can be white. Different colors allow consumers to choose specific combinations, which can increase the likelihood that patients will continue using the device for treatment.

[0480] By forming headbands, tubes, or catheters in this way, headbands can be specifically designed to adjust or conform to the contours of a patient's face. The shape of a fabric catheter can be determined by how the inner and outer layers are cut and attached to each other, rather than by a straight cylindrical tube.

[0481] 5.3.3.1.1.5 Patient Interface During Use

[0482] like Figures 4B-4DThe patient interface 3000 shown can be worn on a patient's head. Once in place, pressurized air is supplied through air delivery tube 3348. Pressurized air from air delivery tube 3348 passes through left arm 3302 or right arm 3304 or both arms. The air then passes through component connection ports or ports 3154 and 3155 and enters pad assembly 3150. Air is supplied to the patient in this manner.

[0483] In some configurations, the cross-section of tube 3350 can be altered or varied as pressurized air passes through it. For example... Figure 4F 、 4G As shown in 4H, the inner layer 3352 is substantially planar. In some forms, during use, the inner layer 3352 can protrude or bend away from the outer layer 3354 between the connectors 3312. That is, the inner surface 3358 of the inner layer 3352 can have a positive curvature. In other words, the outer surface 3374 of the inner layer 3352 has a negative curvature between the connectors 3312. Curvature can help separate other parts of the inner layer 3352 from the patient's face or head. For example, curvature can separate the connector from the patient's face and increase patient comfort.

[0484] In some forms, the outer layer 3354 may also expand when subjected to pressurized air during use of the patient interface 3000. Although the outer layer 3354 is formed in a predetermined shape, it is not a rigid structure and can expand when exposed to pressurized air. This expansion can be caused by the material itself (e.g., the outer layer 3354 can be stretched) or by the movement of the edges of the tube 3350 toward each other. For example, the connectors 3312 may move toward each other, causing the curvature of the inner surface 3356 of the outer layer 3354 to become more correct than in the unpressurized state. During use, the shape can be adjusted according to the patient's specific comfort and tactile sensation.

[0485] Additionally, as previously stated, the permeability of tube 3350 can be adjusted in specific areas. In one area, tube 3350 can be completely airtight, while in another area, a specific amount of air can be allowed to pass through tube 3350. For example, in some forms, the permeability of tube 3350 can be adjusted to allow a specific amount of air to be delivered from tube 3350 to the patient's cheek. Furthermore, tube 3350 can be adjusted such that air is only allowed to move through one layer of tube 3350 (i.e., through inner layer 3352 towards the patient or through outer layer 3354 away from the patient).

[0486] The fabric structure of Tube 3350 allows for positioning and stabilization with less resonance compared to conventional air delivery tubes and catheters, which is less disruptive to patients and thus improves treatment compliance.

[0487] 5.3.3.1.1.6 Headband Positioning

[0488] In some forms of the technology, the 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, as Figure 4C As shown, a tab 3346 configured to connect to the head strap 3420 protrudes outward from the tube 3350 in a generally rearward direction. The tab 3346 may have a hole or groove therein to receive the end of the head strap 3420. However, as shown, the strap 3420 may be secured between the inner layer 3352 and the outer layer 3354. That is, the strap 3420 may be secured without any additional material other than the materials of the inner layer 3352 and the outer layer 3354. For example, the strap 3420 may be secured using thermosetting or thermoplastic materials of the inner layer 3352 and the outer layer 3354. Furthermore, the strap 3420 may extend into the cavity of the tube 3350 or may be located outside the tube 3350. In other forms, the strap 3420 may be in the form of a line or cord or other tubular structure passing through an opening in the tab 3346.

[0489] In some forms of this technology, the rear strap 3420 is adjustable. In some forms, the strap 3420 may include a hook-and-loop fastener, allowing a portion of the rear strap 3420 to pass through a hole in the tab 3346 and be secured to itself. In some forms of the technology, the angle of the strap 3420 relative to the 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.

[0490] In some forms of the technology, the strap 3420 applies a force to the tube 3350 to pull the tube in a direction at least partially rearward (e.g., backward) at the location of the tabs 3346. The strap 3420 can also apply a force to the tube 3350 to pull the tube in a direction at least partially downward (e.g., downward). The magnitude of the force can be adjusted by changing the length of the strap 3420 between the tabs 3346.

[0491] In some forms of technology, for example Figure 4C As shown, the direction of the force applied to the tube 3350 by the strap 3420 can also be changed. The direction can be changed by adjusting the angle of the strap 3420 relative to the tube 3350 or the patient's head. In some embodiments of the technology, the position where the strap 3420 applies force to the tube 3350 can be changed by adjusting the position of the strap 3420 fixed to the tube 3350.

[0492] In some forms of technology, when worn by a patient, the seal-forming structure 3100 tends to detach from the patient or from the front, and downwards or downwards. The headband 3300 is arranged to counteract or resist these tendencies. The tube 3350, together with the strap 3420, provides upward and backward forces to keep the seal-forming structure 3100 in place during use. Additionally, the tube 3350, together with the strap 3420, provides additional backward and upward forces to ensure that the sealing layer 3102 provides a seal for the patient's airway. The headband 3300 receives downward forces from the seal-forming structure 3100, which are at least partially counteracted by the arm support 3314. Furthermore, the top of the tube 3350 allows the headband 3300 to remain in place in the upward / downward direction, while the strap 3420 helps maintain the headband 3300 in the forward / backward direction.

[0493] The direction and magnitude of the force required for a secure fit and effective seal can vary between patients based on the position of the 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 strap 3420 allows the force to be balanced across a range of head shapes and sizes to keep the headband 3300 in a comfortable position while maintaining an effective seal.

[0494] 5.3.3.1.1.7 Connection Port Configuration

[0495] The tube 3350 includes multiple connecting parts configured to allow air to pass into and out of the tube 3350. These connecting parts are integrated within the tube 3350 to provide a seamless or smooth transition and connection to other components of the treatment device. These connecting parts may be formed from a different material than the tube 3350. In some forms, these connecting parts are rigid or stiff plastics resistant to bending or compression. This material can be used to reduce the possibility of air congestion through the connecting parts.

[0496] refer to Figure 4M and 4N The figure depicts a connection port 3600. As shown, the connection port 3600 includes an upper surface 3602 and an opposite lower surface 3604. A channel 3606 extends between the upper surface 3602 and the lower surface 3604 to guide air from an inlet 3608 to either side of the tube 3350. Air is guided in and through the inlet 3608, through the upper surface 3602, and into the channel 3606. The air is then guided along the tube 3350 to the patient's mouth and / or nose.

[0497] See details Figure 4MThe connection port 3600 is depicted within a portion of the tube 3350. In some forms, the connection port 3600 may not be sealed or connected to the layers of the tube 3350. That is, the connection port 3600 is capable of sliding along the inner surface of the layers of the tube 3350. The connection port 3600 may restrict lateral movement by means of the shape of the tube 3350, rather than being sealed or mechanically connected to the layers of the tube 3350. For example, the width of the tube 3350 may taper or decrease, such that the connection port 3600 cannot slide to a great extent.

[0498] refer to Figure 4O The figure depicts an alternative form of the connection port of this technology. As shown, the connection port 3701 includes an outer portion 3702 and an inner portion 3704. The inner portion 3704 can be inserted into the tube 3350 such that the inner portion 3704 is located between the inner layer 3352 and the outer layer 3354. The outer portion 3702 includes an extension that interacts with the inner portion 3704. The outer portion 3702 is positioned around an opening in the tube 3350 and aligned with the inner portion 3704. The outer portion 3702 can be snapped into the inner portion 3704 or otherwise secured to the inner portion 3704. In this way, the outer layer 3354 is secured between the inner portion 3704 and the outer portion 3702 of the connection port 3701. Furthermore, the inner portion 3704 may be equipped with a support to prevent the inner layer 3352 from abutting against the outer layer 3354 at the connection port. As shown, the inner portion 3704 includes a support 3706. The support 3706 is a cage structure that allows airflow through the opening of the connection portion 3700 and to the rest of the tube 3350, while also providing a gap or space between the inner layer 3352 and the outer layer 3354 of the tube 3350.

[0499] Additional connecting parts allow tube 3350 to be connected to sealing structure 3100. As shown, two connecting parts are attached to tube 3350, and these two connecting parts are connected to either side of frame 3152 of sealing structure 3100. Component connection port 3154 can be formed in a similar manner to connection port 3600. Furthermore, component connection port 3154 is configured to engage with an opening in sealing structure 3100, allowing fluid connection between pad assembly 3150 and tube 3350. By using more than one connecting part, i.e., when the patient lies on their side and one side of the tube collapses due to the weight of the patient's head, air will also be delivered to the patient.

[0500] 5.3.3.1.1.8 Manufacturing method of headband tube

[0501] The air delivery system of the stable structure 3300, such as tube 3350, can be formed and manufactured using various techniques. In some forms, each of these layers or sheets of fabric used to form tube 3350 can be pre-formed to have a specific cross-section. These layers or sheets can be coated with silicone, polyurethane, thermoplastic, thermosetting materials, or other conformable materials. The material can be the same as the aforementioned material used to form the fabric membrane. In some forms, the layer can also be used as a fabric membrane. After receiving the conformable material, these sheets or layers can then be placed in a mold. Next, the layer or sheet can be heated to melt the conformable material. The heat is then removed from the layer, causing the conformable material to solidify. The layer can then be removed from the mold, leaving the layer in the shape of the mold.

[0502] Now refer to Figures 8A-8F This diagram illustrates an overview of a process for forming a tube or air delivery system. As shown, the mold 3800 is formed in a generally concave shape. The shape of the mold 3800 can be changed or modified according to the desired shape of the tube to be produced. The fabric sheet 3360 can be a fabric sheet formed from the aforementioned materials. In some forms, the fabric sheet 3360 may already include a fabric film layer along the surface of the fabric sheet 3360. However, in… Figures 8A-8F In the form shown, the fabric sheet 3360 does not yet include the fabric film. The fabric sheet 3360 is then placed in the mold, as... Figure 8B As shown. After the fabric sheet 3360 has been fully oriented, another sheet is placed on top of the fabric sheet 3360. Figure 8C and 8D As shown, the fabric film 3362 is oriented relative to the fabric sheet 3360. The fabric film 3362 can be a film formed of silicone, thermoplastic, or other materials as described above regarding textile films. Figure 8D In the steps shown, the combination of fabric sheet 3360 and fabric film 3362 can be heated to melt or partially melt the film and / or otherwise adhere to the surface of fabric sheet 3360. The combined fabric sheet 3360 and fabric film 3362 can then be removed from mold 3800 after fabric film 3362 has cured. Once fabric film 3362 has cured, it can take the shape of mold 3800, and therefore fabric sheet 3360 can also take the shape of mold 3800, thus forming the aforementioned inner layer 3352. Note that one or both of inner layer 3352 and outer layer 3354 can be thermoformed into a predetermined shape. In other instances, neither inner layer 3352 nor outer layer 3354 is thermoformed.

[0503] In some forms, combinations of multiple formed sheets and films can be used to form the tubes or sections of an air delivery system. For example... Figure 8E and 8FAs shown, both the inner layer 3352 and the outer layer 3354 are thermoformed and can be combined to form the tube 3350. The tube 3350 can have a stable shape including a specific volume for receiving pressurized air. Furthermore, the tube 3350 is foldable and can be easily folded for storage. Because the tube 3350 includes a fabric membrane 3362, the tube 3350 can be restored to its original shape even after folding or storage. Figure 8F The shape shown. Furthermore, additional or different layers can be used to form more or less rigid structures. For example, the outer layer 3354 can be formed to include a thermosetting material, such as a foam layer, which takes the form of mold 3800 when heated. Additional layers, such as fabric sheets, foam layers, fabric films, or other layers, can be used to provide sufficient shape-retaining features or sufficient stiffness or rigidity to the tube 3350 so that the tube 3350 maintains its shape.

[0504] In other forms, a mandrel can be used. The mandrel can be covered by various layers, such as inner layer 3352, instead of using a negative-shape mold, such as mold 3800. Once covered by the desired layers, the mandrel can be heated, or the individual layers can be heated to activate the thermoplastic or thermosetting material. The mandrel is then removed, thus forming inner layer 3352 or other layers of a specific mandrel shape.

[0505] In another form of this technology, the film or conformal layer can be a liquid or paste. In a further form, the conformal layer may not require thermal curing. For example, when exposed to air, the conformal layer can cure in a manner similar to an adhesive. In a further form, a chemical reaction, such as epoxy resin or fiberglass resin, can be utilized. In some cases, the molding process may limit the shape and design of a particular part. Therefore, in some forms, lay-up methods can be used to form various parts. Laying up involves a mold of a specific shape. A layer, such as a textile or fabric layer, can be placed into the mold. Then, a resin, film material, or other material is placed on the layer. The resin or other conformal material is then cured such that the shape of the layer corresponds to the shape of the mold. In some forms, a release agent can be placed between the textile layer and the mold to help provide easier removal of the layer from the mold. Once removed from the mold, the layer can retain or maintain the shape of the mold.

[0506] like Figure 8G-8K As shown, tube 3363 can be formed using the above-described technique. (As indicated...) Figure 8G As shown, fabric sheet 3360 is placed in mold 3800. Figure 8H In this configuration, fabric film 3362 is placed along fabric sheet 3360. In this form, fabric film 3362 can be applied in liquid form, along with... Figure 8C The method described in the text is the opposite. For example... Figure 8IAs shown, the fabric film 3362 is unfolded along the fabric sheet 3360 such that all appropriate portions of the fabric sheet 3360 are covered by the fabric film 3362. After the fabric film 3362 is cured by heat or other means, the inner layer 3352, comprising the fabric sheet 3360 and the cured fabric film 3362, is removed from the mold 3800. Figures 8A-8F In a similar manner to the tube 3350 shown, the inner layer 3352 can be combined with the outer layer 3354 to form the tube 3350.

[0507] After these two layers (e.g., inner layer 3352 and outer layer 3354) are formed, they can be joined along their longitudinal edges to form a chamber. In some forms, the two layers can be joined using glue or other adhesives. In other forms, the layers can be joined using mechanical fasteners such as nails, screws, or buttons. In other forms, the two layers can be stitched or sewn together. In a further form, the two layers can be welded together. For welding, high-frequency welding or radio frequency welding can be used to weld the two layers. In a further form, a hot cutter can be used to cut the layers, and when cutting, a seal can also be formed between the two layers as the two layers partially melt and solidify, thus forming a seal between the first and second layers.

[0508] In some forms, welded connections can be used at different locations on the fabric conduit. In others, welded connections can be used to attach other components to the fabric conduit or to attach the fabric conduit to other components. Components can be secured to each other using various types of welds, rather than relying on physical fasteners such as threads, clips, snaps, etc. By using welds, bulky connections can be reduced. Furthermore, by utilizing welded connection techniques, additional connecting components may not be necessary. For example, a connection between a fabric conduit and an adapter or connector can be formed by placing a portion of a layer of the fabric conduit around the adapter such that the membrane of the layer abuts against the adapter. The combination of the layer and the adapter can then be subjected to heat to melt the membrane or conform to the adapter. When the membrane solidifies, a secure connection can be formed between the layer and the adapter.

[0509] Reference Figure 8L and 8M The aforementioned techniques can be applied to more complex shapes. Molds and thermoplastic materials can also be used to form three-dimensional shapes along the length of a component, rather than simply shaping the internal cross-section using molds and thermoplastic or thermosetting materials. That is, in addition to forming chambers, molds can be used to allow the tube 3350 to be bent or rotated along three axes and maintain its shape without additional support. Figure 8LAs shown, the mold 3802 includes grooves or receiving portions 3804 extending in a first direction D1 and a vertical direction D2. A fabric sheet 3360 can be cut into a specific shape and then placed along the receiving portion 3804 of the mold 3802. For simplicity, the fabric sheet 3360 may have been laminated with a thermosetting material or other suitable film. Figure 8M As shown, the fabric sheet 3360 is heated to melt the film or conform it to the shape of the receiving portion 3804. Once solidified, the fabric sheet 3360 is removed from the mold 3802 and retains the shape of the receiving portion 3804.

[0510] Tube 3350 can be formed from sheet material molded in mold 3802 (see...) Figures 4L-1 to 4L-4 For example, a second sheet similar to fabric sheet 3360 can be used with... Figures 8A-8F It is formed and connected to the fabric sheet 3360 in a similar manner as shown. Figures 4L-1 to 4L-4 As shown, tube 3350 can be oriented in various directions. That is, tube 3350 can be formed or adapted to return to a three-dimensional object. By forming tube 3350 as a three-dimensional object, the amount or number of folds or bends in tube 3350 during use can be reduced. For example, tube 3350 can be pre-formed with bends or twists, rather than requiring the patient to bend or twist tube 3350 to conform to the patient's face. Knots that may reduce airflow through tube 3350 can be reduced by providing natural bends or turns within the shape of tube 3350, as opposed to forming tube 3350 in a separate step later. Figures 4A-4D As shown, when a patient uses tube 3350, the shape of tube 3350 can correspond to the shape of the patient's face and head. In particular, by shaping tube 3350 during the manufacturing process, pressure points can be reduced.

[0511] In some forms, the first sheet (e.g., fabric sheet 3360) is molded or formed only within a mold (e.g., mold 3802). A non-pre-molded sheet can be attached to the molded sheet so that the second sheet conforms to the shape of the fabric sheet 3360.

[0512] Fabric membranes can be positioned along different surfaces of a fabric. The fabric can be immersed in a material such that all sides are covered or laminated with the membrane. Other forms of fabric membranes can coat or laminate a single surface of the fabric. In some forms, the membrane or curing material can be positioned only along a single surface of the textile layer. That is, in some forms, the first surface of the fabric material can be coated with another material, such as a thermosetting material, and the second surface can be the uncovered textile. In other words, different properties can be present on either side of the material. The membrane can also be formed from a variety of materials. In some forms, the fabric membrane is formed from silicone, while in others, it is formed from polyurethane. Different materials can also be used in other forms.

[0513] In some forms, the fabric membrane can be positioned along a flat or planar sheet of fabric. That is, the fabric sheet can be manufactured and include layers of membrane material along the surface of the fabric. In some forms, the membrane can be laminated onto the fabric in a sheet-like manner. In other forms, the membrane can be spread around the fabric in a liquid or semi-liquid state, such that the membrane covers the surface of the fabric or a portion thereof. The membrane can then be cooled or dried, causing the membrane to cure along the surface of the fabric.

[0514] In some forms, various methods and techniques can be used to form the various components of the treatment device. In some forms, flat or planar materials can be manipulated to form three-dimensional structures for use in the treatment device. These materials can be customized or adjusted to allow for greater comfort compared to other forms. In some forms, the sealing structure can be formed from fabric materials. This material may be less conspicuous, more comfortable, and lighter than other configurations. Additionally, other components can also be formed from planar materials manipulated to form three-dimensional structures. For example, tubes can be formed from planar materials. Furthermore, other components containing or in contact with pressurized air can also be formed from planar materials. Besides components that include or guide pressurized air, other components such as straps can be formed from planar materials manipulated to form three-dimensional structures.

[0515] Known patient interfaces typically also include separate headbands and air delivery components for positioning and delivering breathable gas to masks, etc. Known headbands typically consist of an assembly of elastic (or non-elastic) straps, buckles, locks, and / or clips. Known air delivery components typically consist of a 15-22 mm diameter spiral reinforcing tube and a swivel connector. The arrangement of these known headbands and air delivery components can be difficult to use for less skilled and / or unfamiliar individuals. These known arrangements of the headbands and air delivery components can also be uncomfortable or impractical.

[0516] 5.3.3.1.1.8.1 Cutting and Sealing Methods

[0517] Various methods and techniques can be used to form and join components. In one form, multiple components can be formed using cutting and sealing methods. In this method, each component can be cut into a specific shape. In some forms, these components can then be layered on top of each other after the cutting has occurred. In other forms, multiple layers can be layered on top of each other, and then all layers can be cut at once. In some forms, these layers can also be joined together during the cutting process. For example, in some forms, a hot-cutting knife can be used to cut and fuse these layers together. In this method, the time required to manufacture a particular component can be reduced compared to other manufacturing methods.

[0518] The sheets used to form fabric conduits can be smaller than 750mm × 350mm. In other forms, the sheets can be larger or smaller than 750mm × 350mm. The small size of the sheets allows for the formation of multiple fabric conduits or tubes in a small location. By reducing the area occupied by the components used to form the fabric tubing, manufacturing costs can be reduced because less space needs to be rented or maintained.

[0519] refer to Figures 9A-9E This depicts a current form of the technology, where a tube is formed using a cutting and sealing method. An outer cover 3366, a tube sheet 3364, and a fabric sheet 3360 are depicted. As shown, each sheet includes a fabric membrane or other fusible membrane as described above. As before, the outer cover 3366 can serve as an outer layer and therefore can have different material properties than the tube sheet 3364. The fabric sheet 3360 can be an inner layer and is formed of a material that is soft against the user's skin on its outer surface, while also including a fabric membrane configured to reduce the amount of air passing through the fabric sheet 3360. In some forms, the outer surface 3374 of the fabric sheet 3360 can be configured to rest against the patient's skin.

[0520] like Figure 9A and 9B As shown, these layers are stacked on top of each other. In some forms of this technology, guides indicating the desired cutting positions can be placed on these layers. In some forms, the fabric sheet 3360 can be pre-stretched before assembly. For example, the fabric sheet 3360 can be stretched horizontally, vertically, or both horizontally and vertically to provide a specific configuration. After the upper and lower layers are joined, tension can be released from the fabric sheet 3360, leaving it in an unstretched position. This may cause the upper layer to bend when the fabric sheet 3360 is unstretched. Therefore, a specific shape can be achieved by pre-stretching the lower layer during manufacturing and then releasing the tension.

[0521] exist Figure 9BIn this process, a laser 3382 is used to cut and seal various material sheets. In some forms, welding techniques such as high-frequency (HF) welding or radio-frequency (RF) welding can also be used to form a seal. Additionally, in other forms, a thermal cutter can be used. When the material is cut, the thermosetting, thermoplastic, or conformal film adjacent to the cut line can melt or change its properties. The melting of the film allows the film to interact with adjacent layers. For example, the film of the outer cover layer 3366 can interact with the upper surface of the tube sheet 3364. Similarly, the film of the tube sheet 3364 can interact with the lower surface of the outer cover layer 3366. Furthermore, the film of the tube sheet 3364 can interact with the inner surface of the fabric sheet 3360. In other forms, the tube sheet 3364 may consist only of a film along its lower surface, and the outer cover layer 3366 may include a molten film that interacts with the upper surface of the tube sheet 3364. After the films have melted, they can solidify. During solidification, the sheets are joined together along the cut lines. This is how tube 3450 is formed (see...) Figure 9C The tube 3450, unlike tube 3350, may not have thermoformed inner and outer layers. More specifically, outer layer 3354 and inner layer 3352 may be joined along the outer edge of the joint and not further heated to maintain a specific cross-sectional shape when not exposed to internal air pressure or other forces.

[0522] In some forms, additional components can be incorporated into the fabric conduit during its formation. For example, in some forms, connecting components can be incorporated into the fabric conduit during manufacturing. In some forms, a bend or tube connector can be placed along the inner layer before the outer layer is secured to the inner layer. After placing the tube connector along the inner layer, the outer layer is fitted over the inner layer. Next, a connection is formed between the inner and outer layers. As before, the connection can be formed using various welding techniques. In some forms, the connection between the inner and outer layers also secures the tube connector. However, in other forms, the tube connector can be retained within the conduit's cavity; however, the tube connector may not be physically secured to the inner or outer layer. That is, in some forms, movement of the tube connector can be restricted by friction or space constraints within the cavity. In other forms, the tube connector can be clamped in place, as previously described.

[0523] As shown in the figure, connection port 3600 is arranged between tube sheet 3364 and fabric sheet 3360. Similarly, component connection ports 3154 and 3155 can be positioned similarly. Connection port 3600 and component connection ports 3154 and 3155 are sandwiched between tube sheet 3364 and fabric sheet 3360. Once... Figure 9B As shown, the connection port is sealed and can be located inside tube 3450 without requiring another step to insert or position the connection part inside the tube.

[0524] Reference Figures 9C to 9E Pipe 3450 is described as being in various states. For example... Figure 9D As shown, tube 3450 is depicted in a stable state and not subjected to internal air pressure. In this form, as shown in the cross-section, the outer layer 3354 and the inner layer 3352 are positioned substantially planar along each other's surfaces. That is, unlike the forms previously discussed in this art, tube 3450 is not pre-formed with a specific cross-section. Therefore, compared to other forms of technology, tube 3450 does not occupy as much space when not in use. Furthermore, tube 3450 can be easily stored, making it a tube that is easy to move around in.

[0525] like Figure 9E As shown, tube 3450 expands or opens when subjected to internal pressure, such as air pressure from the treatment device. Air can be forced through connection port 3600, causing air to fill the inner chamber of tube 3450. The air can then flow to the end of tube 3450 and to another connection mechanism, such as component connection ports 3154 and 3155, or to the patient's nose or mouth. (See also: Special Reference) Figure 9E As shown in the cross-section, tube sheet 3364 and outer cover layer 3366 are positioned along the upper part of the cross-section, while fabric sheet 3360 is positioned along the lower part. Because connection port 3600 and component connection ports 3154 and 3155 are placed between tube sheet 3364 and fabric sheet 3360, airflow from the treatment device is directed to connection ports 3600 and component connection ports 3154 and 3155, and therefore does not extend between tube sheet 3364 and outer cover layer 3366. In other forms, these sheets can be designed to allow air to pass through either of these layers. Furthermore, connection ports 3600 and component connection ports 3154 and 3155 can be located in various positions depending on specific environmental or design requirements.

[0526] In some forms, the inner layer 3352 and / or the outer layer 3354 may be formed of a non-stretchable material. That is, in some forms, the inner layer 3352 and the outer layer 3354 may not stretch when subjected to internal air pressure, but may still be as... Figure 9E The expansion is as depicted. In other forms, the inner layer 3352 and / or the outer layer 3354 may be formed of a resilient material that stretches under internal pressure. In a further form, the inner layer 3352 may comprise a non-stretched fabric, while the outer layer 3354 comprises a stretched fabric. For example, the stretch or elongation of the inner layer 3352 and the outer layer 3354 may differ.

[0527] When formed in the manner described above, the outer layer 3354 can be cut or sliced ​​such that it extends around the inlet 3608 of the connection port 3600. Similarly, the inner layer 3352 can be cut or sliced ​​such that it extends around the component connection ports 3154 and 3155. The outer layer 3354 can be cut or sliced ​​before or after it is attached to the inner layer 3352. In some forms, the outer layer 3354 can then be heated at a specific location, causing the membrane to melt and align with the inlet 3608 of the connection port 3600. The membrane associated with the tube sheet 3364 is then allowed to solidify, forming a strong connection between the outer layer 3354 and the connection port 3600. A similar arrangement can be used for the inner layer 3352 and the component connection ports 3154 and 3155.

[0528] In other forms, the outer layer 3354 and the inner layer 3352 can be flexible, stretchable, and resilient, allowing the outer layer 3354 and / or the inner layer 3352 to be stretched around the inlet 3608 of the connection port 3600 or similar inlets of the component connection ports 3154 and 3155. Because the outer layer 3354 includes a diaphragm that contacts the connection port 3600, the diaphragm can help provide a sufficient seal between the outer layer 3354 and the connection port 3600. That is, the elasticity of the outer layer 3354 can cause the outer layer 3354 to contract around the opening of the connection port 3600. The elasticity of the outer layer 3354 combined with the membrane allows a seal to be formed between the connection port 3600 and the outer layer 3354. Similar to a rubber band, the outer layer 3354 can be pressed against the inlet 3608 by friction rather than by a permanent connection. The frictional fit can limit the movement of the connection port 3600, keeping the connection port 3600 in a specific position.

[0529] Additionally, the connection between the outer layer 3354 and the connection port 3600 can be adjusted to allow a specific amount of oxygen or air to leak through the connection. This specific leakage eliminates the need for separate valves that allow the handling of excess air, oxygen, or exhaust gas during use.

[0530] In other forms, tube 3450 can be formed such that tube 3450 has a predetermined shape, such as tube 3350. For example, inner layer 3352 and outer layer 3354 can be arranged around a mandrel and then subjected to heating to form a specific cross-section. These layers can then be cut and sealed such that, apart from thermoforming, inner layer 3352 and outer layer 3354 are connected to each other during the cutting process.

[0531] 5.3.3.1.2 Strap Stiffness

[0532] In some forms, varying amounts of conformal membrane can be used to form the component. In some forms, the conformal membrane can be specifically placed along various surfaces. Conformal materials can be used to provide specific reinforcement in various areas of the strap or other component. For example, a strap such as strap 3420 is used to help secure the patient interface 3000 to the patient's face. In some forms, specific areas of the strap may require increased or additional support compared to other parts of the strap. Furthermore, in some forms, the stretching or elasticity of the strap can be limited by utilizing silicone or polyurethane membranes.

[0533] See Figures 5A-5E The diagram depicts a strap. The strap includes an inner layer, a membrane layer, and an outer layer. Although depicted as having an outer layer, it is not necessary to include it. That is, in some forms, an elastic inner layer 3422 and a membrane layer 3424 can be used without an outer layer 3426. Figure 5A As shown, the strap 3420 can interact with the tube 3350 to secure the patient interface 3000 in place relative to the patient. For ease of observation, the membrane layer 3424 is shown in the figure with a considerable thickness. The membrane layer 3424 can be substantially thinner than the outer layer 3426 or the inner layer 3422. For example, the membrane layer 3424 can be less than 10% of the thickness of the outer layer 3426 or the inner layer 3422.

[0534] See Figure 5B A portion of the bandage 3420 is depicted isolated from the rest of the patient interface 3000. As shown, the bandage 3420 includes an outer layer 3426 and an inner layer 3422. A membrane layer 3424 lies between these layers and, in some forms, connects these layers to each other. That is, the bandage 3420 can be exposed to a heat source, causing the membrane layer 3424 to melt or change shape and cool, thereby connecting the inner layer 3422 and the outer layer 3426 to each other. Figure 5B As shown, film layer 3424 does not extend the full length of inner layer 3422. In other forms, film layer 3424 may extend the entire length of inner layer 3422. In yet another form, one of these layers may not extend the entire distance of strap 3420. For example, in some forms, outer layer 3426 may extend only along strap 3420 for the same or similar distance as film layer 3424. In an example, the entire length of outer layer 3426 can be secured to inner layer 3422 using film layer 3424. Furthermore, in some forms, the film may be adhered along the entire length of the shortest layer. The two layers can then be combined and adhered to each other using a thermoplastic or thermosetting material such as film layer 3424.

[0535] like Figure 5CAs shown, a portion of the inner layer 3422 is laminated with the membrane layer 3424. In some forms, the membrane layer 3424 may be formed of the same material as the fabric membrane discussed for tube 3350. By using the same material in various parts of the patient interface, manufacturing costs can be reduced compared to other forms. The inner layer 3422 may be formed of an elastic or stretchable material conforming to the shape of the patient's head. Additionally, the outer layer 3426 may also be made of the same or similar material in the same or similar configuration. These layers may be formed of natural or synthetic materials. In some forms, these layers may be fabrics, while in others, they may be rubber or plastic components. Furthermore, although the inner layer 3422 and the outer layer 3426 are described as being made of the same or similar materials having the same or similar properties, the inner layer 3422 and the outer layer 3426 may have different properties, such as tensile strength, stiffness, flexibility, and other properties. The material for each layer can be selected according to the specific properties desired for the strap 3420.

[0536] See also Figure 5D and 5E In areas where the membrane layer 3424 is absent, the inner layer 3422 has different tensile properties than the outer layer 3426. For example, when subjected to a tension T, the inner layer 3422 stretches a first distance 3428. As shown, when subjected to the same tensile force T, the membrane layer 3424 stretches together with the outer layer 3426 a second distance 3430. The second distance 3430 is smaller than the first distance 3428. Therefore, the membrane layer 3424 can limit the stretching in the specific area where the membrane layer 3424 is applied. That is, while allowing stretching, the membrane layer 3424 can reduce the distance that either the inner layer 3422 or the outer layer 3426 can stretch. This type of configuration can be used in specific areas requiring stepped tensile properties to provide sufficient support for the device. Although the outer layer 3426 is depicted, in some forms of this technology, the outer layer 3426 may not be used. The inner layer 3422 can be used for strapping without using another layer such as the outer layer 3426. In this configuration, the straps can be oriented such that the membrane layer 3424 faces away from the patient. In this way, the soft texture of the inner layer 3422 can rest against the patient's face. Therefore, the membrane layer 3424 can be used to restrict stretching without covering, for example, the outer layer 3426.

[0537] In addition to controlling the stretching rate of specific components, the use of membrane 3424 can also control the recovery rate. That is, membrane 3424 can increase the ability of elastic bands, such as straps 3420, to return to their original unstretched state.

[0538] In some forms, membrane layer 3424 can be used to provide structural support for the bandage. In some forms, the bandage may twist or rotate during use, causing it to come out of position and resulting in wrinkles and patient discomfort. In such cases, a diaphragm can be used to support the bandage and prevent it from rotating or twisting during use.

[0539] Various straps can be used to support the pad assembly, ensuring it provides a sufficient seal for the patient's nose or mouth area. For example... Figure 5F As shown, the head strap 3432 is combined with the tube 3434 of the alternative patient interface 3436.

[0540] See Figure 5G The image depicts a head strap component. The head strap 3432 may include the various features described above. See also... Figure 5H An exploded view of the head strap 3432 is depicted. As shown, the head strap 3432 includes an inner layer 3437, an outer layer 3438, straps 3439-3442, and a padding 3443. The inner layer 3437 and the outer layer 3438 surround or clamp a portion or all of the component. As shown, the inner layer 3437 and the outer layer 3438 completely clamp the padding 3443 in the middle and surround a portion of the straps 3439-3442. In some forms, the inner layer 3437 and / or the outer layer 3438 may be laminated using a film or silicone or polyurethane layer, as previously described in reference tube 3350. The inner layer 3437 and the outer layer 3438 may be aligned and then subjected to heat, causing the film between the inner layer 3437 and the outer layer 3438 to melt and then bond these layers together. As shown, the inner layer 3437 and the outer layer 3438 may also be adhered to or attached to the padding 3443. In other forms, the membrane layer may be absent in the area of ​​the pad 3443. That is, the pad 3443 may be located in a pocket between the inner layer 3437 and the outer layer 3438; however, the pad 3443 may not be physically attached to the inner layer 3437 or the outer layer 3438. Furthermore, in some forms, the straps 3439-3442 may be secured using adhesive. However, in other forms, the straps 3439-3442 are secured to the inner layer 3437 and the outer layer 3438 by a membrane.

[0541] The components of the head strap 3432 can be spaced apart in various orientations. For example... Figure 5GAs shown, strap 3442 is spaced apart from strap 3441 by a portion of inner layer 3437 and a portion of outer layer 3438. Similarly, strap 3442 is spaced apart from padding 3443 by a portion of inner layer 3437 and outer layer 3438. Various other configurations can be used. For example, in some forms, strap 3442 may contact strap 3441. In a further form, strap 3442 and strap 3441 may be a single piece. Other variations are also possible. For example, padding 3443 may be larger or smaller, or may be absent. The tactile feel of the components can be altered and customized by changing the size, shape, and orientation of various components. As shown, head strap 3432 may have various different stretchable areas. Area X1 includes straps 3439-3442 and they have primary stretchability, and in some forms may be substantially non-stretchable. The second region is region X2, which includes straps 3439-3442, a portion of the inner layer 3437, and the outer layer 3438. This has a second degree of stretchability, and it can also be substantially non-stretchable. The third region is region X3, which is between the ends of straps 3439-3442 and the padding 3443. This has a third degree of stretchability. The final stretchable region is region X4, which includes the padding 3443, the inner layer 3437, and the outer layer 3438. These different regions can be varied according to the manufacturer's intent or desired characteristics.

[0542] like Figure 5G The configuration shown allows for a variety of features within a single head strap 3432 without the need for bulky and potentially uncomfortable connecting components. By integrating the diaphragm as the connecting material, the weight of the head strap is also reduced compared to other forms.

[0543] 5.3.3.2 Positioning and stabilizing structures according to other examples of this technology

[0544] Further examples of positioning and stabilizing structures are described below. It should be noted that the features described below can be used or combined with features described in other examples of this disclosure. For example, the tube described below can be used with the mat module / mat assembly described in other examples, and vice versa. Furthermore, individual features of any structure described in any example can be used or combined with features from other examples.

[0545] 5.3.3.2.1 Headband

[0546] like Figure 10 and 11As shown, the non-invasive patient interface 9000, 10000 according to an example of the present technology may include the following functional aspects: a sealing forming structure 9100, an inflation chamber 9200, a positioning and stabilizing structure 9300, at least one exhaust port 9400, 9400-1, and a connection for connecting to an air circuit (e.g., Figure 1A-1C The air circuit 4170 shown is connected to a port 9600 in one form. In this example, the sealing structure 9100 and the inflation chamber 9200 are provided by a cushion module 9150. The cushion module 9150 in this example is a support cushion module. In other examples, it may be a nose pillow cushion assembly or other types of cushion assemblies.

[0547] In some forms of this technology, the positioning and stabilizing structure 9300 includes one or more tubes 9350 that deliver 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 9200 and the sealing structure 9100. Figure 10 and 11 In the illustrated form of this technology, the positioning and stabilizing structure 9300 includes two tubes 9350 that deliver air from the air circuit 4170 to the sealing structure 9100. The tubes 9350 are integral parts of the positioning and stabilizing structure 9300 of the patient interface 9000 to position and stabilize the sealing structure 9100 of the patient interface to an appropriate portion of the patient's face (e.g., nose and / or mouth). This allows the conduit of the air circuit 4170, which provides pressurized airflow, to connect to the connection port 9600 of the patient interface at a location other than in front of the patient's face, which may be unsightly for some individuals. While a pair of tubes 9350 has some advantages (described below), in some instances, the positioning and stabilizing structure 9300 includes only a single tube 9350 configured to cover one side of the patient's head. A strap or other stabilizing component may be positioned on the other side of the patient's head between the tip of the single tube 9350 and the sealing structure 9100 to provide balancing forces on the sealing structure 9100.

[0548] Because air can be included and passed through the headband tube 9350 to deliver pressurized air from the air circuit 4170 to the patient's airway, the positioning and stabilizing structure 9300 can be described as inflatable. It should be understood that an inflatable positioning and stabilizing structure 9300 does not require all components of the positioning and stabilizing structure 9300 to be inflatable. For example, in Figure 10 and 11 In the example shown, the positioning and stabilization structure 9300 includes an inflatable headband tube 9350 and a non-inflatable strap 9310.

[0549] In some forms of this technology, Figure 10 and 11The patient interfaces 9000 and 10000 shown may include a connection port 9600 located near the top, side, or rear of the patient's head. For example, in Figure 10 and 11 In the illustrated form of this technology, the connection port 9600 is located at the top of the patient's head. In these examples, the patient interface 9000, 10000 includes a bend 9610 to which the connection port 9600 is disposed. The bend 9610 can be rotated relative to the positioning and stabilizing structure 9300 (e.g., via a swivel ring 9614) to isolate the movement of the catheter connected to the connection port 9600 from the positioning and stabilizing structure 9300. The bend 9610 can be connected to a fluid connection opening in or to a component to which the headband tube 9350 is connected.

[0550] Alternatively, the conduit connected to the connection port 9600 may be rotatable relative to the bend 9610. In the illustrated example, the bend 9610 includes a rotary conduit connector that includes the connection port 9600, to which the conduit of the air circuit 4170 can be connected, allowing the conduit to rotate about its longitudinal axis relative to the bend 9610. In some examples, the air circuit 4170 may be connected to a fluid connection opening. The bend 9610 may be rotatably connected to the fluid connection opening or to a ring received within the fluid connection opening.

[0551] The connection port is not positioned so that the catheter connected to the front of the patient interface is unsightly and / or protrudes. For example, a catheter connected to the front of the face may easily become tangled in bedding or sheets, especially if the catheter extends downward from the patient interface during use. Using a patient interface with a connection port can make it easier or more comfortable for the patient to be in one or more of the following positions: in a lateral or sideways position; in a supine position (i.e., lying on their back with their face up); and in a prone position (i.e., lying face down). Furthermore, connecting the catheter to the front of the patient interface may exacerbate a problem known as tube drag, where the catheter may provide an undesirable dragging force on the patient interface, causing it to move away from the face.

[0552] exist Figure 10 and 11In the illustrated form of the present technology, the positioning and stabilizing structure 9300 includes two tubes 9350, each tube 9350 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 curved tube 9610 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 instances of the technology, the patient interface 9000 may include a different number of tubes, such as one tube, or three or more tubes. In one example, where the patient interface has tubes 9350, a single tube 9350 is positioned on one side of the patient's head during use (e.g., across a cheek region) and a strap forms part of the positioning and stabilizing structure 9300 and is positioned on the other side of the patient's head during use (e.g., across another region) to help secure the patient interface 9000 to the patient's head.

[0553] exist Figure 10 and 11 In the illustrated form of the technology, two tubes 9350 are fluidly connected to each other at their upper ends and fluidly connected to a connection port 9600. In the illustrated example, tube 9350 is a separate tube connected to a coronal connector 9360. Tubes 9350 are indirectly connected to each other via the coronal connector 9360 and can be disconnected, for example, for cleaning or storage. In another example, the two tubes are integrally formed and include a fluid connection opening, with a swivel bend connected to the fluid connection opening. In other examples using separate tubes, they can be indirectly connected together, for example, each can be connected to a T-shaped catheter with two catheter arms, each catheter arm being fluidly connected to tube 9350. The coronal connector 9360 may include a third catheter arm. The connection port 9600 may include a bend 9610 received in a fluid connection opening 9390 at the center of the coronal connector 9360. The fluid connection opening may form a sealing flange 9362. The bend 9610 may be received in a ring in the fluid connection opening 9390 and can form a seal with the sealing flange 9362 provided to the ring. The bend 9610 can be configured to rotate within the ring. The fluid connection opening 9390 can also be considered as the connection port 9600 itself.

[0554] In some instances, the tube 9350 may be formed of fabric, spacer textiles, and / or foam materials. In some instances, the spacer textile material itself comprises multiple layers. The spacer textile may include a fabric sandwich structure. The spacer textile may include a face layer, a back layer, and an inner spacer layer. The inner spacer layer may be formed of a fiber network and is relatively open.

[0555] Because the interlayer is highly compressible and breathable, spacer textiles can be advantageously used to provide good cushioning. The interlayer can also be resilient. Spacer textiles can be used in patient contact portions 9348 or non-patient contact portions 9349, and can be either an interlayer or an outer layer. In other instances, tubes 9350 can be formed from semi-rigid materials, such as elastomeric materials like silicone. These tubes can have a natural, pre-shaped form, but can have at least some ability to deform if forces are applied to them or they conform to the patient's head. For example, the tubes can be generally arched or curved, their shape approximating the contour of the patient's head between the top of the head and the nasal or oral region.

[0556] In some instances, the positioning and stabilizing structure 9300 may include a sleeve surrounding the tube 9350. In some instances, the patient interface 9000 may not include a sleeve, while in other instances, the patient interface 9000 may include more or all of the sleeve covering the tube 9350. The sleeve may be formed to fit a curved shape to the tube 9350. In some instances, the sleeve is formed of smooth textile fabric. The sleeve may provide greater comfort against the patient's face than a tube 9350 without any covering.

[0557] As described in U.S. Patent 6,044,844 (the contents of which are incorporated herein by reference), if the tube 9350 is crushed during use, for example if it is squeezed between the patient's face and a pillow, the tube 9350 may be crush-resistant to prevent breathable gas from flowing through the tube. A crush-resistant tube may not be necessary in all cases, as the pressurized gas within the tube can act as a clamp to prevent or at least limit crushing of the tube 9350 during use. A crush-resistant tube may be advantageous in the presence of only a single tube 9350, as gas flow would be restricted and therapeutic efficacy would cease or be reduced if the single tube became blocked during use.

[0558] In some forms of the technology, one or more portions of the tube 9350 may be rigidified by one or more rigidifying or hardening elements. Examples of rigidifying elements include: sections of the tube 9350 that are relatively thicker than other sections; portions of the tube 9350 formed of a material that is relatively more rigid than the materials forming other parts; and rigid members that are attached to the inside, outside, or embedded in sections of the tube. Using such rigidifying elements helps control how the positioning and stabilizing structure 9300 functions during use, for example, whether the tube 9350 is more likely to deform if a force is applied to it, and whether the shape of the tube 9350 is more likely to be maintained if a force is applied. Therefore, selecting a location for such a rigidifying element within the tube 9350 can help improve comfort when wearing the patient interface 9000 and can help maintain a good seal at the sealing formation structure 9100 during use. The rigidifying or hardening elements may be located within the positioning and stabilizing structure 9300, which is configured to support relatively heavy sealing formation structures, such as full-face or oronasal pad assemblies.

[0559] In some forms of the technology, one or more portions of these tubes 9350 may be formed longitudinally from at least two portions, with the rigidifying elements being inside, outside, or embedded in the intersection of the at least two portions.

[0560] Figure 10 and 11 The tubes 9350 in the illustrated technical forms are all between 15 and 30 cm in length, for example, between 20 and 27 cm. The tube length is chosen to suit the size of a typical patient's head, for example, the area near the top of the head where the upper end of the tube 9350 is located, and when it descends along a roughly arc-shaped path along both sides of the head and passes through the patient's cheek area (such as...). Figure 10 and 11 The distance between the areas near the patient's airway opening (the arcuate path taken by the tube 9350 shown) is where the lower end of the tube 9350 connects to the pad module 9150 at the opening. In some instances, the patient interface 9000 can be configured such that the length of the tube 9350 can be varied. It should be understood that the length of the tube 9350 will depend on the length of other components in the patient interface 9000, such as the length of the coronal connector 9360 to which the upper end of the tube 9350 is connected and / or the size of the inflation chamber 9200.

[0561] 5.3.3.2.1.1 Positioning of headband components

[0562] Each tube 9350 can be configured to receive airflow from a connection port 9600 on the top of the patient's head and deliver the airflow to a sealed structure at the patient's airway inlet. Figure 10 and 11In one example, at least one tube 9350 extends through the patient's cheek region and above the patient's ear between the sealing forming structure 9100 and the connecting port 9600; that is, the portion of tube 9350 connected to the pad module covers the maxillary region of the patient's head in use, and the portion of tube 9350 covers the area of ​​the patient's head above the supraauricular base. Each of one or more tubes 9350 may also be located on one or both of the patient's sphenoid and / or temporal bones, and the patient's frontal and parietal bones. The connecting port 9600 and the bend 9610 may be located above the patient's parietal, frontal, or the connection between them in use.

[0563] Figure 10 and 11 An exemplary form of the illustrated technology has a tube 9350 that bends around the upper part of the patient's head, from the upper end of the tube 9350 connected to a curved tube 9610 on the top of the head to the point where the headband 9310 connects to the tube 9350, which has a relatively small curvature in the sagittal plane. Between the point where the rear headband 9310 connects to the tube 9350 and the lower end of the tube 9350, the lower end of the tube 9350 connects to a pad module 9150 in front of the patient's airway below the nose. The tube 9350 bends forward between the patient's ear and eye and across the cheek area. The radius of curvature of this portion of the tube 9350 can be in the range of 60-100 mm, for example 70-90 mm, such as 80 mm. The lower end of the tube 9350 and the portion of the tube 9350 to which the rear headband 9310 connects can be oriented at an angle in the range of 65-90°, for example 75-80°. The actual curvature of the tube 9350 in the portion above the strap 9310 and the actual curvature of the tube 9350 in the portion below the strap 9310 depend on the patient setting and will actually vary depending on the shape and size of the patient's head and the patient's preferences.

[0564] The degree to which the patient interface 9000 fits an individual patient can be altered by changing the length of the tube 9350 and, alternatively or additionally, by changing the position of the patient interface 9000 or its portion on the patient's head. For example, the patient interface 9000 with a given length of tube 9350 can be adjusted to better fit the patient by moving a portion of the positioning and stabilizing structure 9300 in a rearward or forward direction on the patient's head. For example, positioning the connection of tube 9350 further forward (i.e., in the forward direction) above the patient's head allows the patient interface 9000 with a given length of tube 9350 to fit a larger head than if the connection of tube 9350 were positioned further backward (i.e., in the rearward direction) above the patient's head. In most patients, if the connection of tube 9350 is positioned forward, the upper portion of tube 9350 is located on a smaller portion of the patient's head compared to the case where the connection of tube 9350 is positioned backward. In some instances of the technology, tube 9350 has less flexibility, and the patient may have fewer degrees of freedom to move the upper portion of tube 9350 forward or backward on their head.

[0565] In some forms of this technology, the patient interface 9000 is configured such that the connection port 9600 can be positioned across the top of the patient's head, allowing the patient interface 9000 to be positioned to suit the comfort or fit of an individual patient. This can be achieved in such a way that the sealing structure 9100 forms an effective seal with the patient's face, regardless of the position of the connection port 9600 on the patient's head, by separating the movement of the upper part of the patient interface 9000 from the movement of the lower part of the patient interface 9000. This separation can be achieved, for example, by making the tube 9350 sufficiently flexible so that the upper portion of the tube 9350 can move.

[0566] In one form of this technology, the patient interface 9000 is configured such that the connection port 9600 is positioned approximately at the top of the patient's head. The connection port 9600 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 central point is marked on the ear. In some forms of the technology, the positioning and stabilizing structure 9300 is configured to be worn in different positions, such that the connection port 9600 can be positioned near the top of the patient's head in the sagittal plane, up to approximately 20 mm in front of or behind the central point on the ear.

[0567] In some embodiments of this technology, the connection port 9600 can be positioned in the sagittal plane and aligned with the junction between the frontal and parietal bones. The connection port 9600 can be positioned approximately above the junction of the coronal and sagittal sutures. In some configurations, the upper portion of the tube 9350 can be located above and / or along a portion of the coronal suture. However, as described above, in some forms of this technology, the patient can move the connection port 9600 back and forth to adjust the fit of the patient interface 9000.

[0568] The advantage of placing the tube 9350, which covers the patient's head slightly anterior to the uppermost point (e.g., at or near the coronal suture), is that the risk of the tube 9350 straddling the patient's head in a posterior direction during use is reduced. In many patients, there may be a recess or "divot" at the meeting point of the coronal and sagittal sutures. When the tube 9350 is located within a divot, the positioning and stabilizing structure 9300 can be particularly stable. Therefore, in some instances, the tube 9350 is configured to have appropriate curvature and / or bending capability for placement on the coronal suture.

[0569] As described above, in some instances of this technology, the patient interface 9000 includes a seal-forming structure 9100 in the form of a support pad, which is typically located below the nose and seals to the lower periphery of the nose. A positioning and stabilizing structure 9300 may be constructed and arranged to pull the seal-forming structure 9100 into the patient's face below the nose using a sealing force vector having a posterior and superior direction (e.g., posterosuperior direction). A sealing force vector having a posterosuperior direction can help the seal-forming structure 9100 form a good seal against the lower periphery of the patient's nose and the forward-facing surfaces of the patient's face on either side of the nose or upper lip.

[0570] In some instances, the positioning and stabilizing structure 9300 can apply a sealing force vector during use, the sealing force vector having a posterosuperior direction at approximately 35° relative to the patient's Frankfort horizontal line (in Figure 2E (See the center mark). The upper portion of tube 9350 (e.g., the portion of tube 9350 above strap 9310) may be vertically oriented, and the posterior headband strap 9310 may extend from tube 9350 in a posterior direction at an angle of approximately 35° relative to the patient's Frankfort level. In one example, an angle of approximately 125° is formed between the strap 9310 and the upper portion of tube 9350, wherein the strap 9310 is connected to tube 9350.

[0571] In some instances, the positioning and stabilizing structure 9300 can be configured such that the upper portion of the tube 9350 crosses the patient's head, slightly anterior to the uppermost point. For some patients, this may result in the tube 9350 being slightly tilted forward rather than vertically aligned (e.g., in the coronal plane) to lie within a small recess at or near the coronal suture of the skull. In such instances, the patient can adjust the tension in the bandage 9310 to balance forces and achieve an optimal sealing force vector.

[0572] In some instances, the positioning and stabilizing structure 9300 can be configured to apply force to the sealing forming structure 9100 at an angle that bisectes the angle formed between the upper lip and the columella (e.g., the surface forming the nasolabial angle) in a posterior-upward direction.

[0573] In some embodiments of the present invention, the tube 9350 is configured to receive the strap 9310 at a position above and close to the patient's ear. If the strap 9310 is connected to the tube 9350 which is too high relative to the patient's head, the strap 9310 may tend to ride on the back of the patient's head. Additionally, the strap 9310 may form an excessive angle relative to the upper portion of the headband tube 9350, causing the patient to need to excessively tighten the strap 9310, which may result in excessive tension in the positioning and stabilization structure 9300 and make the strap 9310 more likely to ride on the back of the patient's head. Therefore, it is advantageous to set the connection between the strap 9310 and the tube 9350 as low as possible, but at a sufficient distance from the top of the patient's ear, so that when the strap 9310 is tightened, the tube 9350 is not pulled into contact with the patient's ear.

[0574] 5.3.3.2.1.2 Headband tubing fluid connection

[0575] Two tubes 9350 are fluidly connected at their lower ends to the inflation chamber 9200. Figure 10 and 11In one example, tube 9350 forms a fluid connection with pad module 9150 and sealing structure 9100. In some forms of the technology, the connection between tube 9350 and pad module 9150 is achieved through 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 pad module 9150. In one form, tube 9350 is formed of fabric and foam material, and the lower end of each tube 9350 is overmolded or bonded to a rigid connector, for example, made of polypropylene, polycarbonate, nylon, etc. The rigid connector may include a convex mating feature configured to connect to a concave mating feature on pad module 9150. Alternatively, the rigid connector may include a concave mating feature configured to connect to a convex mating feature on pad module 9150. The same connection method used to connect tube 9350 to pad module 9150 can also be applied to the connection between tube 9350 and another inflation chamber 9200 or sealing structure 9100 (e.g., nose pillow pad module).

[0576] In a hard-to-hard connection between pipe 9350 and the port, a pressure-actuated seal, such as a peripheral sealing flange, can be used. When pressurized gas is supplied through pipe 9350, the sealing flange is pushed against the joint between the inner circumferential surfaces of the pipe and the port of the inflation chamber 9200 to enhance the seal between them. If the port is flexible and a rigid connector is provided to pipe 9350, the aforementioned pressure-actuated seal can also be used to ensure the connection is airtight.

[0577] A similar connection mechanism can be used to fluidly connect tube 9350 to crown connector 9360, with connection port 9600 fluidly attached to crown connector 9360 in some technical form. In one embodiment, the swivel bend connected to connection port 9600 is rotatable to drive a port size adjustment mechanism that decreases or increases the size of the port into which tube 9350 is inserted, thereby improving tube fit by increasing or decreasing pressure and reducing unintentional leakage.

[0578] 5.3.3.2.1.3 Extendable accordion-style structure

[0579] The patient interface 9000 may include one or more extendable tubing segments. In some instances, the extendable tubing segment includes an extendable accordion-like structure. The patient interface 9000 may include a positioning and stabilizing structure 9300, which includes at least one gas delivery tube comprising a tube wall having an extendable accordion-like structure.

[0580] 5.3.3.2.1.4 Bending performance

[0581] In some instances of this technology, portions of the positioning and stabilizing structure 9300 are configured to be more resistant to bending in or around some directions or axes, but not to bending in or around other directions or axes.

[0582] For example, compared to orthogonal directions, Figure 10 and 11 The upper portion of each tube 9350 of the positioning and stabilizing structure 9300 shown may be more flexible in a particular direction. Each gas delivery tube 9350 of the positioning and stabilizing structure 9300 may include an upper tube portion 9304 configured to cover the upper region of the patient's head during use. In some instances of this technology, the upper tube portion 9304 may include a stretchable tube structure (e.g., one of the options disclosed in PCT Patent Publication WO 2017 / 124155 or U.S. Patent Application 62 / 764,995, the entire contents of each of which are incorporated herein by reference) or may be non-stretchable. Figure 10 and 11 In the illustrated form of the technology, the tube is essentially inextensible, except for any inherent tensile properties of the material forming the tube.

[0583] The upper tube portion 9304 includes a first end 9305 and a second end 9306. In an example, the first end 9305 is configured to cover or abut against the upper portion of the patient's head in a generally sagittal plane (e.g., the general top and center of the patient's head). The second end 9306 is configured to laterally cover the patient's head from the first end 9305 (e.g., closer to the side of the patient's head). The second end 9306 may be located laterally or below the first end 9305. Figure 10 and 11 The positioning and stabilizing structure 9300 is capable of bending at least to some extent around multiple axes. For example, the upper tube portion 9304 of the positioning and stabilizing structure 9300 is capable of hanging downwards over the patient's head and also bending in the front-back direction.

[0584] In some embodiments of this technology, the upper tube portion 9304 may further include one or more reinforcing portions between the first end 9305 and the second end 9306. The reinforcing portions may be configured to provide greater resistance to relative movement between the first end 9305 and the second end 9306 in the forward and / or rearward directions than in the upward and / or downward directions. In some embodiments, the reinforcing portions may be provided along the entire length of the tube 9350, and in some embodiments, different stiffness may be provided to the tube 9350 along its length.

[0585] When the patient wears the positioning and stabilizing structure 9300, the upper tube portion 9304 can exhibit relatively low resistance to bending in the vertical direction, allowing the second end 9306 to move downward relative to the first end 9305. This advantageously allows the upper tube portion 9304 to "hang" downward from the top to the side of the patient's head. The flexibility in the upward / downward direction is advantageous in enabling the upper tube portion 9304 to conform to the curvature of the patient's head.

[0586] Additionally, the upper tube portion 9304 can exhibit relatively high resistance to bending in the horizontal direction, preventing the first end 9305 from unintentionally moving forward and / or backward relative to the second end 9306. This advantageously keeps the upper tube portion 9304 in the desired position across the top of the patient's head. Due to the low resistance to bending in the forward and / or backward directions, the upper tube portion 9304, and particularly the connection port 9600, is unlikely to cross forward or backward along the top of the patient's head during use. Assuming the connection to the air circuit 4170 is provided on the top of the patient's head, this resistance to forward or backward movement of the upper tube portion 9304 is particularly advantageous for the patient interface 9000, meaning that tube drag forces can act directly on the upper tube portion 9304.

[0587] In some instances, the upper tube portion 9304 may include a shape that inherently provides advantageous resistance to bending. For example, the upper tube portion 9304 may include a somewhat rectangular or trapezoidal cross-section, wherein the parallel long sides are configured to abut against a surface of the patient's head. The long sides of the rectangular cross-section provide relatively large resistance to bending of the upper tube portion in directions parallel to the long sides (e.g., in the forward and / or backward directions during use). However, the short sides of the rectangular / trapezoidal cross-section may not provide such large resistance to bending of the upper tube portion 9304 and in directions parallel to the short sides (e.g., in the downward and / or upward directions during use).

[0588] It should be understood that the cross-section of the upper tube portion 9304 does not have to be perfectly rectangular. For example, these corners and / or short sides can be rounded, such that the cross-section of the upper tube portion 9304 can be substantially oval or elliptical. However, a cross-sectional shape that presents a flat surface of the tube on the side facing and contacting 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.

[0589] The reinforcing portion can be formed by the tube wall of the tube 9350 or by one or more rigid structures provided to the tube wall of the tube 9350. A tube 9350 including reinforcing portions on both the front and rear sides can advantageously provide high resistance to bending toward both the front and rear sides of the tube 9350. However, in some instances, a reinforcing portion is provided only on one of the front or rear sides of the tube 9350, because depending on the stiffness, a reinforcing portion on only one side can provide sufficient resistance to bending in both directions.

[0590] In some instances, portions of the tube 9350 (e.g., the front and / or rear portions) may include reinforcing sections reinforced with one or more rigidifying elements. The tube 9350 may be rigidified using one or more rigidifying components embedded within the tube wall, having a higher rigidity than the tube 9350. For example, the tube wall may be attached to an elongated rod or bar formed of a material harder than the tube wall. In other instances, reinforcing portions of the tube wall may be provided by other features of the tube wall geometry. In one instance, the tube wall may include a greater material thickness on the front and / or rear sides of the tube 9350.

[0591] 5.3.3.2.1.5 Lower Pipe Section

[0592] The patient interface 9000 may include one or more lower tube portions 9363. For example, Figure 10 and 11 The patient interface 9000 shown includes a tube 9350, the lower portion of which includes a lower tube portion 9363. The lower tube portion 9363 is configured to cover the patient's cheek and can be configured to contact the patient's face below the cheekbone. Each lower tube portion 9363 may be located on a curve extending downward from the connection between the corresponding headband tubes 9350, and then extending in a direction toward the front and middle of the sealing structure 9100 to avoid the patient's cheekbone.

[0593] Advantageously, the positioning and stabilizing structure 9300 of the patient interface 9000 is not located on the patient's cheekbone. The area of ​​the patient's face below the cheekbone is typically more fleshy, and patients may find it more tolerable for the headband tube 9350 to be located in these areas. Furthermore, since the cheekbone area of ​​the patient's face is relatively immobile and deformable, the lower tube portion 9363 rests firmly against the fleshy cheek area. Additionally, the patient's cheekbone helps prevent the lower tube portion 9363 of the headband tube 9350 from crossing over the cheekbone towards the patient's eyes. When the lower tube portion 9363 is fitted onto the patient's cheek below the cheekbone, the hardness and prominence of the patient'...

Claims

1. A patient interface, comprising: a plenum chamber capable of being pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing, a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that the flow of air at the therapy pressure is delivered to at least one entrance to the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the therapy pressure in the plenum chamber throughout a breathing cycle of the patient; a positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: at least one gas delivery tube to deliver the flow of air to the entrance of the patient's airway via the seal-forming structure, the at least one gas delivery tube being constructed and arranged to contact at least one area of ​​the patient's head above a supra-auricular base point of the patient's head in use; and wherein the at least one gas delivery tube comprises an inner fabric layer and an outer fabric layer, wherein the inner fabric layer and the outer fabric layer are connected at a first joint along a first longitudinal edge and at a second joint along a second longitudinal edge; wherein the outer fabric layer is spaced apart from the inner fabric layer between the first joint and the second joint; wherein the outer fabric layer is thermoformed to have a predetermined shape and the inner fabric layer is not thermoformed; and The outer fabric layer supports its own weight between the first joint and the second joint, so that the outer fabric layer is spaced apart from the inner fabric layer when not supported by pressurized air.

2. A patient interface according to claim 1, wherein: The inner fabric layer has different material properties than the outer fabric layer.

3. A patient interface according to claim 1, the inner fabric layer comprising an inner fabric membrane, wherein during use when pressurized with air, the inner fabric membrane is configured to allow air to pass through the inner fabric membrane.

4. A patient interface according to claim 1, wherein the inner fabric layer comprises a conformable inner fabric membrane and the outer fabric layer comprises a conformable outer fabric membrane, wherein the outer fabric layer is thicker than the inner fabric layer.

5. The patient interface of claim 1, wherein: The inner fabric layer has a substantially planar cross-section.

6. A patient interface according to claim 1, wherein the inner fabric layer is fluffy.

7. A patient interface according to claim 1, wherein the inner fabric layer is secured to the outer fabric layer, wherein the outer fabric layer applies tension to the inner fabric layer.

8. A patient interface according to claim 1, wherein said inner fabric layer comprises an outer fabric sheet and an inner fabric membrane, wherein said inner fabric membrane is configured to resist said transfer of air through said outer fabric sheet.

9. A patient interface according to claim 1, wherein the at least one gas delivery tube is configured to extend continuously from the right side of the patient along the parietal bone to the left side of the patient.

10. A patient interface according to claim 1, wherein the at least one gas delivery tube comprises an air supply conduit, wherein the air supply conduit is positioned adjacent to the parietal bone when the patient interface is worn by the patient.

11. A patient interface according to claim 1, wherein the outer fabric layer comprises an outer fabric sheet and an inner fabric membrane, wherein a compliant sheet is sandwiched between the outer fabric sheet and the inner fabric membrane.

12. A patient interface according to any one of claims 1-11, wherein the inner fabric layer is connected to the outer fabric layer at a joint, wherein the width of the joint varies along the length of the at least one gas delivery tube.

13. A patient interface according to any one of claims 1-11, wherein the outer fabric layer has an inner surface, wherein the inner surface of the outer fabric layer has a positive curvature between the first joint and the second joint.

14. A patient interface according to any one of claims 1-11, wherein the inner fabric layer has zero curvature between the first joint and the second joint.

15. A patient interface according to any one of claims 1-11, wherein the inner fabric layer and the outer fabric layer are connected together without stitching.

16. A patient interface according to any one of claims 1-11, wherein the inner fabric layer includes an inner-inner fabric membrane, wherein the outer fabric layer includes an outer-inner fabric membrane, wherein the outer-inner fabric membrane of the outer fabric layer is connected to the inner-inner fabric membrane of the inner fabric layer along the edge of the at least one gas delivery tube, wherein the inner-inner fabric membrane and the outer-inner fabric membrane connect the inner fabric layer to the outer fabric layer and form an airtight membrane between the inner fabric layer and the outer fabric layer.

17. A patient interface according to any one of claims 1-11, wherein: The inner fabric layer and the outer fabric layer are connected at a first edge by a first joint and at a second edge by a second joint and are spaced apart from each other between the first joint and the second joint, wherein no reinforcement is used along the inner fabric layer between the first joint and the second joint.

18. A patient interface according to any one of claims 1-11, wherein: During use and by air pressurization, the inner fabric layer expands away from the outer fabric layer.

19. A patient interface according to any one of claims 1-11, wherein the outer fabric layer comprises a conformable material, wherein the conformable material is thermoformed into a predetermined non-planar cross-sectional shape.

20. A patient interface according to any one of claims 1-11, wherein the at least one gas delivery tube is thermoformed into a predetermined shape so that the first arm extends along a first plane and the upper portion extends along a second plane substantially perpendicular to the first plane without external force or pressure.

21. A patient interface comprising: a plenum chamber capable of being pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing, a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that the flow of air at the therapy pressure is delivered to at least one entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapy pressure in the plenum chamber throughout the patient's breathing cycle in use; a positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: at least one gas delivery tube to deliver the flow of air to the entrance of the patient's airway via the seal-forming structure, the at least one gas delivery tube being constructed and arranged to contact at least one area of ​​the patient's head above a supra-auricular base point of the patient's head in use; and wherein the at least one gas delivery tube comprises an inner fabric layer and an outer fabric layer, the inner fabric layer being connected to the outer fabric layer along a first edge of the gas delivery tube to form a first seam of the gas delivery tube, such that the inner fabric layer is spaced apart from the outer fabric layer along a central portion of the gas delivery tube to form a tubular shape, wherein the first seam provides rigidity to the gas delivery tube, and wherein the inner fabric layer has a substantially planar cross-sectional shape, wherein the outer fabric layer has a predetermined non-planar cross-sectional shape, and wherein the outer fabric layer is resilient such that when subjected to an external force, the cross-sectional shape of the outer fabric layer changes, and when the external force is released, the outer layer returns to the predetermined non-planar cross-sectional shape.

22. A patient interface according to claim 21, wherein: The inner fabric layer has different material properties than the outer fabric layer.

23. A patient interface according to claim 21, the inner fabric layer comprising an inner fabric membrane, wherein during use when pressurized with air, the inner fabric membrane is configured to allow air to pass through the inner fabric membrane.

24. A patient interface according to claim 21, wherein the inner fabric layer comprises a conformable inner fabric membrane and the outer fabric layer comprises a conformable outer fabric membrane, wherein the outer fabric layer is thicker than the inner fabric layer.

25. A patient interface according to claim 21, wherein: The inner fabric layer is joined to the outer fabric layer along a second edge of the gas delivery tube to form a second seam of the gas delivery tube.

26. A patient interface according to claim 21, wherein said inner fabric layer is fluffy.

27. A patient interface according to claim 21, wherein the inner fabric layer is secured to the outer fabric layer, wherein the outer fabric layer applies tension to the inner fabric layer.

28. A patient interface according to claim 21, wherein said inner fabric layer comprises an outer fabric sheet and an inner fabric membrane, wherein said inner fabric membrane is configured to resist said transfer of air through said outer fabric sheet.

29. A patient interface according to claim 21, wherein the at least one gas delivery tube is configured to extend continuously from the right side of the patient along the parietal bone to the left side of the patient.

30. A patient interface according to claim 21, wherein said at least one gas delivery tube comprises an air supply conduit, wherein said air supply conduit is positioned adjacent to said parietal bone when said patient interface is worn by said patient.

31. A patient interface according to claim 21, wherein: The width of the first seam varies along the length of the at least one gas delivery tube.

32. A patient interface according to any one of claims 21-31, wherein the inner fabric layer is connected to the outer fabric layer at a joint, wherein the width of the joint varies along the length of the at least one gas delivery tube.

33. A patient interface according to any one of claims 21-31, wherein the outer fabric layer has an inner surface, wherein the inner surface of the outer fabric layer has a positive curvature.

34. A patient interface according to any one of claims 21-31, wherein the inner fabric layer has zero curvature.

35. A patient interface according to any one of claims 21-31 wherein the inner fabric layer and the outer fabric layer are connected together without suturing.

36. A patient interface according to any one of claims 21-31, wherein the inner fabric layer includes an inner-inner fabric membrane, wherein the outer fabric layer includes an outer-inner fabric membrane, wherein the outer-inner fabric membrane of the outer fabric layer is connected to the inner-inner fabric membrane of the inner fabric layer along the edge of the at least one gas delivery tube, wherein the inner-inner fabric membrane and the outer-inner fabric membrane connect the inner fabric layer to the outer fabric layer and form an airtight membrane between the inner fabric layer and the outer fabric layer.

37. A patient interface according to any one of claims 21-31, wherein: The inner fabric layer is connected to the outer fabric layer along a second edge of the gas delivery tube to form a second seam of the gas delivery tube, and the inner fabric layer and the outer fabric layer are spaced apart from each other between the first seam and the second seam, wherein no reinforcer is used along the inner fabric layer between the first joint and the second joint.

38. A patient interface according to any one of claims 21-31, wherein: During use and by air pressurization, the inner fabric layer expands away from the outer fabric layer.

39. A patient interface according to any one of claims 21-31, wherein the outer fabric layer comprises a conformable material, wherein the conformable material is thermoformed into a non-planar cross-sectional shape.

40. A patient interface according to any one of claims 21-31, wherein the at least one gas delivery tube is thermoformed into a predetermined shape so that the first arm extends along a first plane and the upper portion extends along a second plane substantially perpendicular to the first plane without external force or pressure.

41. A patient interface comprising: a plenum chamber capable of being pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing, a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that the flow of air at the therapy pressure is delivered to at least one entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapy pressure in the plenum chamber throughout the patient's breathing cycle in use; a positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: at least one gas delivery tube to deliver the air flow to the entrance of the patient's airway via the seal-forming structure, the at least one gas delivery tube being constructed and arranged to contact at least one area of ​​the patient's head above a supra-auricular base point of the patient's head in use; wherein the at least one gas delivery tube comprises an inner fabric layer and an outer fabric layer, the outer fabric layer comprising an inner layer of foam and an outer fabric sheet; wherein the outer fabric layer is more rigid than the inner fabric layer; wherein the inner fabric layer and the outer fabric layer may be connected along a first longitudinal edge and a second longitudinal edge; and An air passage is formed between the inner fabric layer and the outer fabric layer.

42. A patient interface according to claim 41, wherein the outer fabric layer has a predetermined non-planar cross-sectional shape, and wherein the outer fabric layer is resilient so that when subjected to an external force, the shape of the outer fabric layer changes, and when the external force is released, the outer layer returns to the predetermined non-planar cross-sectional shape.

43. A patient interface according to any one of claims 41 or 42, wherein the outer fabric layer is spaced apart from the inner fabric layer between the first longitudinal edge and the second longitudinal edge; and Wherein the outer fabric layer supports its own weight between the first longitudinal edge and the second longitudinal edge such that the outer fabric layer remains spaced apart from the inner fabric layer when not supported by pressurized air.

44. A patient interface according to any one of claims 41-43, wherein the inner fabric layer comprises an inner fabric membrane, wherein during use when pressurized with air, the inner fabric membrane is configured to allow air to pass through the inner fabric membrane.

45. A patient interface according to any one of claims 41-44, wherein the inner fabric layer comprises a conformable inner fabric membrane and the outer fabric layer comprises a conformable outer fabric membrane, wherein the outer fabric layer is thicker than the inner fabric layer.

46. ​​A patient interface according to any one of claims 41-45, wherein the inner fabric layer has a substantially planar cross-section.

47. A patient interface according to any one of claims 41-46, wherein the inner fabric layer is fluffy.

48. A patient interface according to any one of claims 41-47, wherein the inner fabric layer is secured to the outer fabric layer, wherein the outer fabric layer applies tension to the inner fabric layer.

49. A patient interface according to any one of claims 41-48, wherein said inner fabric layer comprises an outer fabric sheet and an inner fabric membrane, wherein said inner fabric membrane is configured to resist said transfer of air through said outer fabric sheet.

50. A patient interface according to any one of claims 41-49, wherein the at least one gas delivery tube is configured to extend continuously from the right side of the patient along the parietal bone to the left side of the patient.

51. A patient interface according to any one of claims 41-50, wherein the at least one gas delivery tube comprises an air supply conduit, wherein the air supply conduit is positioned adjacent to the parietal bone when the patient interface is worn by the patient.

52. A patient interface according to any one of claims 41-51 wherein the outer fabric layer comprises an inner fabric membrane, wherein the foam inner layer is sandwiched between the outer fabric sheet and the inner fabric membrane.

53. A patient interface according to any one of claims 41-52, wherein the inner fabric layer is connected to the outer fabric layer at a joint, wherein the width of the joint varies along the length of the at least one gas delivery tube.

54. A patient interface according to any one of claims 41-53, wherein the outer fabric layer has an inner surface, wherein the inner surface of the outer fabric layer has a positive curvature between the first longitudinal edge and the second longitudinal edge.

55. A patient interface according to any one of claims 41-54, wherein the inner fabric layer has zero curvature between the first longitudinal edge and the second longitudinal edge.

56. A patient interface according to any one of claims 41-55, wherein the inner fabric layer and the outer fabric layer are connected together without suturing.

57. A patient interface according to any one of claims 41-56, wherein the inner fabric layer includes an inner-inner fabric membrane, wherein the outer fabric layer includes an outer-inner fabric membrane, wherein the outer-inner fabric membrane of the outer fabric layer is connected to the inner-inner fabric membrane of the inner fabric layer along the edge of the at least one gas delivery tube, wherein the inner-inner fabric membrane and the outer-inner fabric membrane connect the inner fabric layer to the outer fabric layer and form an airtight membrane between the inner fabric layer and the outer fabric layer.

58. A patient interface according to any one of claims 41-57, wherein the inner fabric layer and the outer fabric layer are connected at a first edge by a first joint and at a second edge by a second joint, and are spaced apart from each other between the first joint and the second joint, wherein no reinforcement is used along the inner fabric layer between the first joint and the second joint.

59. A patient interface according to any one of claims 41-58, wherein: During use and by air pressurization, the inner fabric layer expands away from the outer fabric layer.

60. A patient interface according to any one of claims 41-59, wherein: The patient interface is configured to allow the patient to breathe from the environment through their mouth without pressurized air flowing through the plenum inlet port, or the patient interface is configured to not cover the patient's mouth.

61. A patient interface according to any one of claims 41-60, wherein the inflatable chamber is constructed of a transparent material.

62. A patient interface according to any one of claims 41-61 configured such that no part of the patient interface enters the mouth in use.

63. A patient interface according to any one of claims 41-62, configured such that the seal-forming structure does not extend beneath the metallic raised area in use.

64. A patient interface according to any one of claims 41-63 constructed and arranged such that the inflatable chamber does not cover the eye in use.

65. A patient interface according to any one of claims 41 to 64, configured such that the positioning and stabilising structure provides, in use, at least (60 gf / cm 2 )×mask area (cm 2 ))’s holding power.

66. A patient interface according to any one of claims 41 to 65, configured such that the positioning and stabilising structure provides, in use, a velocity of less than (30 (gf / cm 2 )×mask area (cm 2 ))’s force.

67. A patient interface according to any one of claims 41-66, wherein a portion of the positioning and stabilising structure is configured to be breathable to allow moisture vapour to escape and / or be transferred therethrough.

68. A positioning and stabilising structure providing a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, said seal-forming structure being constructed and arranged to form a seal with an area of ​​said patient's face surrounding an entrance to said patient's airway for use in sealing delivery of a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout said patient's breathing cycle, said positioning and stabilising structure comprising: at least one gas delivery tube to receive the air flow from a connection port on top of the patient's head and deliver the air flow to the entrance of the patient's airway via the seal-forming structure, the gas delivery tube being constructed and arranged to contact, in use, a region of the patient's head at least above a supra-auricular base of the patient's head, the gas delivery tube comprising a tube wall defining a hollow interior through which air can flow to the seal-forming structure, the tube wall comprising: a patient contacting portion comprising a plurality of layers including a first fabric outer layer and a foam inner layer, the first fabric outer layer comprising a foam inner layer, the first fabric outer layer comprising a foam inner layer, the first fabric outer layer being configured to rest against the patient's head in use; and a non-patient contacting portion on a side of the gas delivery tube opposite the delivery patient contacting portion and comprising a second fabric outer layer; wherein the second outer fabric layer is thicker than any other layer of the non-patient contacting portion; and Wherein the patient contacting portion comprises a greater hardness than the non-patient contacting portion.

69. A positioning and stabilising structure according to claim 68, wherein: The patient contacting portion has a greater thickness than the non-patient contacting portion.

70. A positioning and stabilizing structure according to any one of claims 68 and 69, wherein the patient contacting portion is thermoformed by a first thermoforming process and the non-patient contacting portion is thermoformed by a second thermoforming process, wherein the first thermoforming process provides greater stiffness to the patient contacting portion than the second thermoforming process provides to the non-patient contacting portion.

71. A positioning and stabilising structure according to any one of claims 68-70, wherein the patient contacting portion and the non-patient contacting portion are both formed of layers, the patient contacting portion comprising a greater number of layers than the non-patient contacting portion.

72. A positioning and stabilising structure according to any one of claims 68-71, wherein the patient contacting portion comprises a rigidising layer.

73. A positioning and stabilising structure according to any one of claims 68 to 72, wherein: The patient contacting portion includes a rigidifying member.

74. A positioning and stabilising structure according to any one of claims 68-73, wherein the patient contacting portion comprises a harder material than the non-patient contacting portion.

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