Headgear tubing for patient interface

Abstract

To provide headgear tubing for a patient interface.SOLUTION: A patient interface for treating sleep disordered breathing includes a textile tube that also provides support for a seal-forming structure. An inner layer and outer layer that are included in the textile tube are joined along seams to form an air chamber or passageway. The textile tube can be pre-shaped such that the textile tube resiliently returns to a predetermined shape prior to introduction of pressurized air.SELECTED DRAWING: Figure 4B

Description

[Technical Field]

[0001] 1 Cross-reference to related applications This application claims the benefit 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 benefit of Australian Provisional Application No. AU2019901040, filed March 28, 2019, and Australian Provisional Application No. AU2019901459, filed April 30, 2019, each of which is incorporated by reference in its entirety herein. [Background technology]

[0002] 2. Technical Background 2.1 Technology field The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof.

[0003] A particular form of the present technology relates to patient interfaces used in respiratory therapy, prevention and amelioration of respiratory-related disorders.

[0004] 2.2 Description of Related Art 2.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and oral cavity form the entrance to a patient's airways.

[0005] These airways contain a series of branching tubes that become narrower, shorter, and more numerous the deeper they travel into the lungs. The primary function of the lungs is gas exchange, allowing oxygen from the air to enter the venous blood and carbon dioxide to leave. The trachea divides into the right and left main bronchi, which further divide into the terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into the respiratory bronchioles and ultimately the alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory zone. See: "Respiratory Physiology," by John B. West, Lippincott Williams & Wilkins, 9th edition published 2011.

[0006] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

[0007] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall diseases.

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes of upper airway closure or obstruction during sleep. This is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the tongue region, soft palate, and posterior oropharyngeal wall during sleep. This condition causes affected individuals to experience breathing pauses typically lasting 30 to 120 seconds, sometimes as many as 200 to 300 times per night. This can result in excessive daytime sleepiness, which can contribute to cardiovascular disease and brain damage. This condition is common, particularly among middle-aged, overweight men, but patients often experience no symptoms. See U.S. Pat. No. 4,944,310 (Sullivan).

[0009] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory regulator, characterized by alternating periods of waxing and waning ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with recurrent sleep arousals, which can cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0010] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following conditions:

[0011] Patients with respiratory failure (a type of respiratory insufficiency) may experience unusual shortness of breath during exercise.

[0012] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0013] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics, including increased resistance to air movement, prolonged expiratory phase of breathing, and a decrease in normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0014] Neuromuscular disease (NMD) is a broad term encompassing numerous diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle impairment, resulting in the inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be categorized as rapidly progressive or slowly progressive: (i) rapidly progressive disorders, characterized by muscle impairment that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders, characterized by muscle impairment that worsens over years and results in only a modest reduction in life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, difficulty swallowing, difficulty breathing on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0015] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive obstruction and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can lead to severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0016] A range of treatments are available to treat or ameliorate these conditions. Additionally, otherwise healthy individuals can benefit from preventative treatments for respiratory disease. However, these suffer from several deficiencies.

[0017] 2.2.2 Treatment A variety of therapies are used to treat one or more of the above respiratory disorders, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV).

[0018] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that CPAP functions as a pneumatic splint, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, thereby preventing closure of the upper airway. Because treatment of OSA with CPAP therapy can be voluntary, patients may choose not to adhere to treatment if they perceive one or more of the following about the device used to deliver the treatment: it is uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0019] Noninvasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist the patient in breathing and / or maintain adequate oxygen levels in the body by performing some or all of the respiratory functions. Ventilatory support is provided through a noninvasive patient interface. NIV is used to treat CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0020] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments may be improved.

[0021] 2.2.3 Treatment System These treatments may be provided by a treatment system or device. Such systems and devices may also be used to diagnose conditions without treating them.

[0022] The treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0023] 2.2.3.1 Patient Interface A patient interface may be used to provide a wearer with an interface to a respiratory appliance, for example, by providing airflow to the airway entrance. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy being applied, the patient interface may form a seal with, for example, an area of ​​the patient's face, thereby facilitating gas delivery at a pressure sufficient to disperse with atmospheric pressure for therapy implementation (e.g., at a positive pressure of about 10 cmH2O relative to atmospheric pressure). In other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of a gas supply to the airways at a positive pressure of about 10 cmH2O.

[0024] Certain other mask systems may be functionally inadequate in this field. For example, masks intended for purely decorative purposes may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures and not maintain internal air at pressures higher than ambient.

[0025] Certain masks may be clinically unsuitable for this technology (for example, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0026] In certain masks, the patient must insert part of the mask structure into their mouth and create and maintain a seal via their lips, which may be uncomfortable or impractical in this technology.

[0027] Certain masks may be impractical for use while sleeping (eg, when sleeping on your side in bed with your head resting on a pillow).

[0028] There are multiple challenges in designing a patient interface. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. That is, the chin or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory treatment period.

[0029] These challenges can lead to one or more of the following: some masks can be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if worn for extended periods or if the patient is unfamiliar with the system. If the wrong size mask is used, this can lead to reduced compliance, reduced comfort, and poor patient outcomes. While masks specifically designed for aviators, personal protective equipment (e.g., filter masks), SCUBA masks, or anesthesia administration masks may be durable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods (e.g., several hours). Such discomfort can reduce patient compliance with treatment. This is especially true if the mask must be worn while sleeping.

[0030] CPAP therapy can be highly effective in treating certain respiratory conditions if the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Because patients are often encouraged to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect patient compliance.

[0031] Masks for other uses (e.g., aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

[0032] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0033] 2.2.3.1.1 Seal formation structure The patient interface may include a seal-forming structure. Because the patient interface is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may have a direct impact on the effectiveness and comfort of the patient interface.

[0034] Patient interfaces can be characterized in part according to the design intent of where the seal-forming structure engages with the face during use. In one form of patient interface, the seal-forming structure can include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nostrils during use. Such a single element can be designed, for example, to rest on the upper lip region and nasal bridge region of the face. In one form of patient interface, the seal-forming structure can include an element that surrounds the mouth region during use, for example, by forming a seal on the lower lip region of the face. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces can be known by various names depending on their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0035] A seal-forming structure that may be effective in one area of ​​a patient's face may be inappropriate in another area due to, for example, different shapes, structures, variability, and sensitive areas of the patient's face. For example, the seal of swim goggles that rests on the patient's forehead may be inappropriate for use on the patient's nose.

[0036] A particular seal-forming structure may be designed for mass production so that one design is compatible, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-manufactured patient interface, one or both may need to be adapted to form a seal.

[0037] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure engaging against the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or may include a molded or shaped surface of a resilient sealing element constructed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will form between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0038] Another type of seal-forming structure uses a thin flap seal positioned around the periphery of the mask to provide a self-sealing seal against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming portion, poor fit between the face and the mask can require additional force to achieve a seal or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming portion may fold or buckle during use, causing leakage.

[0039] Other types of seal-forming structures may include friction-fit elements that are inserted into the nostrils, for example, but some patients find these seal-forming parts uncomfortable.

[0040] Another form of seal-forming structure may use adhesives to achieve a seal, as some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0041] A range of patient interface seal forming structures are disclosed in the following patent applications (assigned to ResMed Limited: WO1998 / 004310; WO2006 / 074513; WO2010 / 135785).

[0042] One form of nasal pillow is found in the Adam line manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0043] ResMed Limited manufactures the following products that use nasal pillows: SWIFT® Nasal Pillows Mask, SWIFT® II Nasal Pillows Mask, SWIFT® LT Nasal Pillows Mask, SWIFT® FX Nasal Pillows Mask, and MIRAGELIBERTY® Full Face Mask. Embodiments of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: International Patent Application No. WO2004 / 073778 (which describes, among other things, aspects of ResMed Limited's SWIFT® Nasal Pillows); U.S. Patent Application No. 2009 / 0044808 (which describes, among other things, aspects of ResMed Limited's SWIFT® LT Nasal Pillows); International Patent Applications Nos. WO2005 / 063328 and WO2006 / 130903 (which describe, among other things, aspects of ResMed Limited's MIRAGE LIBERTY® full-face mask); and International Patent Application No. WO2009 / 052560 (which describes, among other things, aspects of ResMed Limited's SWIFT® FX Nasal Pillows).

[0044] 2.2.3.1.2 Positioning and stabilization The seal-forming structures of patient interfaces used in positive air pressure therapy are subjected to corresponding forces of air pressure that disrupt the seal, and therefore a variety of techniques are used to position the seal-forming structures and maintain a seal against the appropriate portion of the face.

[0045] One technique involves the use of adhesives, see, for example, U.S. Patent Application Publication No. US2010 / 0000534, but adhesives can be uncomfortable.

[0046] Another technique uses one or more straps and / or stabilizing harnesses. Many such harnesses are one or more of the following: poor fit, bulky, uncomfortable, and cumbersome. When designed to be worn on the patient's head, such harnesses may be referred to as headgear.

[0047] 2.2.3.1.3 Compressed air conduits In one type of treatment system, a flow of pressurized air is provided to the patient interface through a conduit in the air circuit that is fluidly connected to the patient interface such that when the patient interface is positioned on the patient's face in use, the conduit extends forward and away from the patient's face. This is sometimes referred to as an "elephant trunk" style interface.

[0048] Some patients find such interfaces unsightly, resulting in decreased patient compliance if they are discontinued. Additionally, if the conduit is interfaced in front of the patient's face, it may become entangled with bedding.

[0049] 2.2.3.1.4 Pressurized air conduits used to position / stabilize seal-forming structures Another type of treatment system that attempts to address these issues includes a patient interface in which the tubing responsible for delivering pressurized air to the patient's airway also functions as part of the headgear for positioning and stabilizing the seal-forming portion of the patient interface on the appropriate portion of the patient's face. This type of patient interface may also be referred to as one that uses "headgear tubing" or "conduit headgear." Such a patient interface allows a conduit in the air circuit that provides pressurized airflow from a respiratory pressure treatment device to be provided to the patient interface in a location other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication No. US 2007 / 0246043, the contents of which are incorporated herein by reference. In this publication, the conduit connects to a tube in the patient interface through a port positioned on the top of the patient's head during use.

[0050] The Philips DreamWear® nasal mask includes such headgear tubing. One problem with this mask is that the headgear tubes are silicone. The silicone conduits can cause discomfort to patients when facing the patient's face. Additionally, the weight of the headgear can cause discomfort to some patients.

[0051] Using a patient interface with headgear tubing may provide some advantages (e.g., avoiding conduits connecting to the patient interface in front of the patient's face, which can be unsightly and uncomfortable), but it is desirable that a patient interface with headgear tubing be comfortable while forming an effective seal with the patient's face when worn by the patient for extended periods of time while the patient is sleeping.

[0052] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to deliver one or more of the therapies described above, for example, by activating the device to generate an air delivery flow to an interface with the airway. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). As such, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0053] Air pressure generators are known for a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical applications have specific requirements that cannot be met by more common air pressure generators (e.g., the reliability, size, and weight requirements of medical equipment). In addition, even devices designed for medical treatment may suffer from deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0054] One example of a special requirement for a particular RPT device is acoustic noise.

[0055] Table 1 shows the noise output levels of conventional RPT devices (measured on a single sample at 10 cmH2O in CPAP mode using the test method specified in ISO 3744).

[0056] [Table 1]

[0057] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can provide invasive and non-invasive independent respiratory support for patients for a range of conditions, including, but not limited to, NMD, OHS, and COPD.

[0058] The ResMed Elisee® (Elisee with an accent on the first e) 150 ventilator and ResMed VSIII® ventilator can provide invasive and non-invasive dependent respiratory support suitable for adult or pediatric patients for the treatment of multiple conditions. These ventilators offer volume and pressure ventilation modes using single or dual limb circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) and are configured to deliver airflow to the patient's airway. In some cases, the airflow can be delivered to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface, as described above.

[0059] A device designer may be presented with a myriad of choices. Often, conflicting design criteria may make certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular implementation may be significantly affected by minor changes in one or more parameters.

[0060] 2.2.3.3 Humidifier

[0061] Delivery of the airflow without humidification can lead to dryness of the airway. When a humidifier is used with an RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort for the patient's airway. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air. Therefore, humidifiers often have the ability to humidify the airflow in addition to heating it.

[0062] A range of artificial humidification devices and systems are known, but do not meet the special requirements of medical humidifiers.

[0063] Medical humidifiers are typically used when a patient is sleeping or resting (e.g., in a hospital) to increase the humidity and / or temperature of an air stream relative to the ambient air when needed. Bedside medical humidifiers may be compact. Medical humidifiers may be configured to only humidify and / or heat the air stream delivered to the patient, not the patient's surroundings. For example, while room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed into the patient's body, these systems also humidify and / or heat the entire room, which may be uncomfortable for occupants. Additionally, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0064] Although many medical humidifiers are known, such medical humidifiers may suffer from one or more deficiencies, such that some provide inadequate humidification or are difficult or inconvenient for the patient to use.

[0065] 2.2.3.4 Data Management

[0066] For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant" (e.g., whether the patient adheres to one or more "compliance rules" with their RPT device). An example of a compliance rule for CPAP therapy may require a patient to use the RPT device for at least four hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

[0067] There may be other aspects of patient care that benefit from communication of treatment data to third parties or external systems.

[0068] Existing processes for communicating and managing such data can be costly, time consuming, and / or error prone.

[0069] 2.2.3.5 Mandibular repositioning A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one treatment option for sleep apnea and snoring. It is an adjustable oral appliance available from dentists or other suppliers that holds the mandible (lower jaw) in an anterior position during sleep. MRDs are removable devices that are inserted into the mouth before a patient goes to sleep and removed afterward. As such, MRDs are not designed for full-time wear. MRDs can be custom-made or manufactured in standard forms and include bite impression sections designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension on the pharyngeal walls, reducing airway collapse and palatal vibration.

[0070] In certain embodiments, the mandibular advancement device may include an upper splint intended to engage or mate with teeth on the upper jaw or maxilla, and a lower splint intended to engage or mate with teeth on the upper jaw or mandible. The upper and lower splints are laterally connected to each other via a pair of connecting rods that are fixed symmetrically on the upper and lower splints.

[0071] In such a design, the length of the connecting rod is selected so that the mandible is held in a forward position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the level of mandibular protrusion. The dentist can determine the level of protrusion required for the mandible, and the length of the connecting rod is then determined.

[0072] Some MRDs are configured to push the mandible forward relative to the maxilla, while others, such as the ResMed Narval CC® MRD, are designed to hold the mandible in a forward position. The devices also reduce or minimize dental and temporomandibular joint (TMJ) side effects. As such, the devices are configured to minimize or prevent any movement of one or more teeth.

[0073] 2.2.3.6 Ventilation technology Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., ambient).

[0074] The vents may include orifices through which gas can flow when the mask is in use. Many such vents are noisy. Others may become blocked during use, resulting in insufficient pumping. Some vents may disrupt sleep for the patient 1000 and bed companion 1100, for example, due to noise or concentrated airflow.

[0075] ResMed Limited has developed several 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. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0076] [Table 2] is a table of noise for conventional masks (ISO17510-2:2007, 10cmH2O pressure at 1m).

[0077] [Table 2]

[0078] ( * (Only one sample was measured at 10cmH2O in CPAP mode using the test method specified in ISO3744)

[0079] The sound pressure values ​​for various subjects are listed in Table 3 below.

[0080] [Table 3]

[0081] 2.2.4 Screening, diagnostic and monitoring systems Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, but it typically requires specialized clinical staff for system application. PSG typically involves placing 15–20 contact sensors on the human body to record various body signals (e.g., electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), and electromyography (EMG)). PSG for sleep-disordered breathing requires patients to be observed for two nights in a specialized hospital: the first night for pure diagnosis and the second night for clinician-assisted titration of treatment parameters. Therefore, PSG is expensive and inconvenient. Screening, diagnosing, and monitoring sleep-disordered breathing is particularly unsuitable for home use.

[0082] In general, screening and diagnosis involve identifying disease through signs and symptoms. Screening typically produces a true / false result indicating whether a patient's SDB warrants further investigation, while diagnosis often produces clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the progression of disease can continue indefinitely. While some screening / diagnostic systems are adapted solely for screening / diagnosis, some can also be used for monitoring.

[0083] A clinical expert may adequately screen, diagnose, or monitor a patient based on visual observation of the PSG signal. However, there are situations where a clinical expert is unavailable or cannot be paid for. Different clinical experts may have different opinions about a patient's condition. Furthermore, some clinical experts may apply different criteria at different times. Summary of the Invention [Means for solving the problem]

[0084] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory diseases, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0085] A first aspect of the present technology relates to devices used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disease.

[0086] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0087] An aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.

[0088] One form of the present technology involves a patient interface for delivering a supply of pressurized breathable gas to an entrance of a patient's airway.

[0089] Another aspect of the present technology relates to at least one gas delivery tube having an inner textile layer and an outer textile layer, the inner textile layer and the outer textile layer having different cross-sectional shapes.

[0090] Another aspect of the present technology relates to at least one gas delivery tube including an inner woven layer and an outer woven layer, wherein the inner woven layer has a substantially planar cross-sectional shape and the outer woven layer has a predetermined non-planar cross-sectional shape, and the outer woven layer is elastic such that when subjected to an external force, the cross-sectional shape of the outer woven layer changes and when the external force is released, the outer layer returns to the predetermined non-planar cross-sectional shape.

[0091] Another aspect of the present technology relates to a gas delivery tube having an inner woven layer and an outer woven layer, where the outer woven layer is heat formed to have a predetermined shape and the inner woven layer is not heat formed.

[0092] Another aspect of the present technology relates to at least one gas delivery tube having an inner textile layer and an outer textile layer, the inner textile layer and the outer textile layer being joined at a first joint along a first longitudinal edge and at a second joint along a second longitudinal edge, the outer textile layer being spaced apart from the inner textile layer between the first and second joints, the outer textile layer being heat-formed to have a predetermined shape, the inner textile layer not being heat-formed, and the outer textile layer supporting its own weight between the first and second joints such that the outer textile layer remains spaced apart from the inner textile layer when not being supported by pressurized air.

[0093] Another aspect of the present technology relates to at least one gas delivery tube having an inner textile layer and an outer textile layer, the outer textile layer being stiffer than the inner textile layer, the inner textile layer and the outer textile layer being joined along first and second longitudinal edges, and an air passageway being formed between the inner and outer textile layers.

[0094] Another aspect of one form of the present technology includes a patient interface. The patient interface may include a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient. The patient interface may include a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways. The seal-forming structure has holes therein whereby the airflow at the therapeutic pressure is delivered to at least an entrance to the patient's nares. The seal-forming structure may be constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The patient interface may include at least one gas delivery conduit for delivering the airflow through the seal-forming structure to the entrance to the patient's airways, the at least one gas delivery conduit constructed and arranged to contact at least a region of the patient's head above the superior ear base point in use. The at least one gas delivery tube may include an inner woven layer and an outer woven layer. The outer woven layer may have a predetermined non-planar cross-sectional shape. The outer woven layer may be elastic such that when subjected to an external force, the cross-sectional shape of the outer woven layer is altered and when the external force is released, the outer layer returns to the predetermined non-planar cross-sectional shape.

[0095] In embodiments, (a) the inner textile layer may have different material properties than the outer textile layer; (b) the inner textile layer may include an inner textile membrane configured to allow air movement therethrough when pressurized with air in use; (c) the inner textile layer may include a conforming inner textile membrane and the outer textile layer may include a conforming outer textile membrane, the outer textile layer being thicker than the inner textile layer; (d) the inner textile layer may have a substantially planar cross-section; (e) the inner textile layer may be flexible; and (f) the inner textile layer may be secured to the outer textile layer and may be attached to the inner textile layer from the outer textile layer. (g) the inner textile layer may include an outer textile sheet and an inner textile membrane, the inner textile membrane configured to resist air movement through the outer textile sheet; (h) the at least one gas delivery conduit may be configured to extend continuously from the patient's right side along the parietal bone to the patient's left side; (i) the at least one gas delivery conduit may include an air supply conduit, and when the patient wears the patient interface, the air supply conduit is positioned adjacent to the parietal bone; (j) the outer textile layer may include an outer textile sheet and an inner textile membrane, and a conformable sheet is disposed between the outer textile sheet and the inner textile membrane. are sandwiched together, (k) the inner woven layer may be joined to the outer woven layer at a joint, the width of the joint varying along the length of the at least one gas delivery tube, (l) the outer woven layer has an inner surface, the inner surface of the outer woven layer may have a positive curvature, (m) the inner woven layer may have a zero curvature, (n) the inner woven layer and the outer woven layer may be joined together without stitching, (o) the inner woven layer may include an inner inner woven membrane, the outer woven layer may include an outer inner woven membrane, the outer inner woven membrane of the outer woven layer and the inner inner woven membrane of the inner woven layer being joined together along an edge of the at least one gas delivery tube, The inner textile layer is joined to the outer textile layer by a textile membrane and an outer inner textile membrane, and an air-impermeable membrane is formed between the inner textile layer and the outer textile layer; (p) the inner textile layer and the outer textile layer may be joined 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, and no stiffening material is used along the inner textile layer between the first joint and the second joint; (q) when pressurized with air in use, the inner textile layer may expand away from the outer textile layer; and (r) the outer textile layer isThe at least one gas delivery tube may include a shape-conforming material that is heat-formed to a non-planar cross-sectional shape, and (s) the at least one gas delivery tube may be heat-formed to a predetermined shape such that the first arm extends along a first plane and the top extends along a second plane substantially perpendicular to the first plane without external force or pressure.

[0096] Another aspect of one form of the present technology includes a patient interface. The patient interface may include a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient. The patient interface may include a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways. The seal-forming structure has holes therein whereby the airflow at the therapeutic pressure is delivered to at least an entrance to the patient's nares. The seal-forming structure may be constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The patient interface may include at least one gas delivery conduit for delivering the airflow through the seal-forming structure to the entrance to the patient's airways, the at least one gas delivery conduit constructed and arranged to contact at least a region of the patient's head above the superior ear base point in use. The at least one gas delivery tube may include an inner textile layer and an outer textile layer, the inner textile layer and the outer textile layer may be joined at a first junction along a first longitudinal edge and at a second junction along a second longitudinal edge. The outer textile layer may be spaced apart from the inner textile layer between the first junction and the second junction. The outer textile layer may support its own weight between the first junction and the second junction, such that the outer textile layer remains spaced apart from the inner textile layer when not supported by pressurized air.

[0097] In examples according to the above paragraph, (a) the inner textile layer may have different material properties than the outer textile layer, (b) the inner textile layer may include an inner textile membrane configured to allow air movement therethrough when pressurized with air in use, (c) the inner textile layer may include a conforming inner textile membrane and the outer textile layer may include a conforming outer textile membrane, the outer textile layer being thicker than the inner textile layer, (d) the inner textile layer may have a substantially planar cross-section, (e) the inner textile layer may be flexible, and (f) the inner textile layer may be secured to the outer textile layer and be removable from the outer textile layer. (g) the inner textile layer may include an outer textile sheet and an inner textile membrane, the inner textile membrane being configured to resist air movement through the outer textile sheet; (h) the at least one gas delivery tube may be configured to extend continuously from the patient's right side along the parietal bone to the patient's left side; (i) the at least one gas delivery tube may include an air supply conduit, and when the patient wears the patient interface, the air supply conduit is positioned adjacent to the parietal bone; (j) the outer textile layer may include an outer textile sheet and an inner textile membrane, the outer textile sheet and the inner textile membrane being configured to resist air movement through the outer textile sheet; a conformable sheet sandwiched between the inner and outer textile layers; (k) the inner textile layer may be joined to the outer textile layer at a junction, the width of the junction varying along the length of the at least one gas delivery tube; (l) the outer textile layer has an inner surface, the inner surface of the outer textile layer having a positive curvature between the first junction and the second junction; (m) the inner textile layer may have a zero curvature between the first junction and the second junction; (n) the inner textile layer and the outer textile layer may be joined together without stitching; (o) the inner textile layer may include an inner inner textile membrane, and the outer textile layer may include an outer inner textile membrane, the outer inner textile layer having an outer inner textile membrane. the membrane and the inner inner woven membrane of the inner woven layer are joined together along an edge of at least one gas delivery tube, the inner inner woven membrane and the outer inner woven membrane joining the inner woven layer to the outer woven layer, and an air impermeable membrane is formed between the inner woven layer and the outer woven layer; (p) the inner woven layer and the outer woven layer may be joined 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, and no stiffening is used along the inner woven layer between the first joint and the second joint;(q) when pressurized with air in use, the inner textile layer may expand away from the outer textile layer; (r) the outer textile layer may include a shape-conforming material that is heat-formed to a non-planar cross-sectional shape; and (s) the at least one gas delivery tube may be heat-formed to a predetermined shape such that the first arm extends along a first plane and the top extends along a second plane substantially perpendicular to the first plane without external force or pressure.

[0098] Another aspect of one form of the present technology includes a patient interface. The patient interface may include a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for breathing by the patient. The patient interface may include a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways. The seal-forming structure has holes therein whereby the airflow at the therapeutic pressure is delivered to at least an entrance to the patient's nares. The seal-forming structure may be constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use. The patient interface may include at least one gas delivery conduit for delivering the airflow through the seal-forming structure to the entrance to the patient's airways, the at least one gas delivery conduit constructed and arranged to contact at least a region of the patient's head above the superior ear base point in use. The at least one gas delivery tube may include an inner woven layer and an outer woven layer, the outer woven layer being stiffer than the inner woven layer. The inner and outer woven layers may be joined along a first longitudinal edge and a second longitudinal edge. An air passage may be formed between the inner and outer woven layers.

[0099] In an example according to the above paragraph, (a) the outer textile layer may have a predetermined non-planar cross-sectional shape and may be elastic such that the shape of the outer textile layer is changed when subjected to an external force and the outer layer returns to the predetermined non-planar cross-sectional shape when the external force is released; and (b) the outer textile layer may be spaced apart from the inner textile layer between the first longitudinal edge and the second longitudinal edge and the outer textile layer may support its own weight between the first longitudinal edge and the second longitudinal edge such that the outer textile layer is spaced apart from the inner textile layer when not supported by pressurized air. (c) the inner textile layer may include an inner textile membrane configured to allow air movement therethrough when pressurized with air in use; (d) the inner textile layer may include a conforming inner textile membrane and the outer textile layer may include a conforming outer textile membrane, the outer textile layer may be thicker than the inner textile layer; (e) the inner textile layer may have a substantially planar cross-section; (f) the inner textile layer may be flexible; (g) the inner textile layer may be secured to the outer textile layer and tension may be applied from the outer textile layer onto the inner textile layer; and (h) the inner textile layer may be secured to the outer textile layer. (k) the outer woven layer may include an outer woven sheet and an inner woven membrane, and the inner woven membrane may be configured to resist air movement through the outer woven sheet; (i) the at least one gas delivery conduit may be configured to extend continuously along the parietal bone from the patient's right side to the patient's left side; (i) the at least one gas delivery conduit may include an air supply conduit, and when the patient wears the patient interface, the air supply conduit is positioned adjacent to the parietal bone; (k) the outer woven layer may include an outer woven sheet and an inner woven membrane, and a conformable sheet may be sandwiched between the outer woven sheet and the inner woven membrane; (l) the inner woven layer may include an outer woven sheet and an inner woven membrane, and a conformable sheet may be sandwiched between the outer woven sheet and the inner woven membrane; (m) the outer woven layer may have an inner surface, the inner surface of the outer woven layer may have a positive curvature between the first longitudinal edge and the second longitudinal edge; (n) the inner woven layer may have a zero curvature between the first longitudinal edge and the second longitudinal edge; (o) the inner woven layer and the outer woven layer may be joined together without stitching; (p) the inner woven layer may include an inner internal woven membrane, the outer woven layer may include an outer internal woven membrane, the outer internal woven membrane of the outer woven layer and the inner internal woven membrane of the inner woven layer(q) the inner and outer woven layers are joined at a first edge by a first joint and at a second edge by a second joint and are spaced apart from one another between the first and second joints, and no stiffening is used along the inner woven layer between the first and second joints; (r) when pressurized with air in use, the inner woven layer can expand away from the outer woven layer; and (s) the patient interface is configured to accommodate a flow of pressurized air through the plenum chamber inlet port. (t) the plenum chamber may be constructed from a transparent material; (u) the patient interface may be configured such that no part of the patient interface enters the oral cavity in use; (v) the patient interface may be configured such that the seal-forming structure does not extend below the mental protuberance area in use; (w) the patient interface may be constructed and arranged such that the plenum chamber does not cover the eyes in use; and (x) the patient interface may be configured such that, in use, the plenum chamber provides a plenum pressure of at least (6(gf / cm, 2 ) x mask area (cm 2 (y) the patient interface may be configured such that a holding force of (30 (gf / cm 2 ) x mask area (cm 2 )) a force of less than 1 / 2 psi is obtained from the positioning and stabilizing structure, and (z) a portion of the positioning and stabilizing structure can be constructed of a breathable material to allow water vapor to escape and / or transmit therethrough.

[0100] Another aspect of the present technology relates to a patient interface including a plenum chamber, a seal-forming structure, a venting structure, and a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on a patient's head. The positioning and stabilizing structure includes at least one gas delivery conduit for receiving an airflow from a connection port and delivering the airflow through the seal-forming structure to an entrance of the patient's airway, the gas delivery conduit constructed and arranged to contact at least one region of the patient's head above the superior ear-base point of the patient's head in use.

[0101] Another aspect of the present 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-contacting portion including a first outer layer and a first inner layer including an air-impermeable material. The at least one gas delivery tube may include a patient-contacting portion including a second outer layer configured to be positioned on an opposite side of the gas delivery tube toward the patient's head in use to the first outer layer, and a second inner layer including an air-impermeable material.

[0102] Another aspect of the present technology relates to a positioning and stabilizing structure that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to, in use, form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways for sealingly delivering an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout said patient's respiratory cycle. The positioning and stabilizing structure may include at least one gas delivery conduit for receiving an airflow from a connection port on the patient's head and delivering the airflow through the seal-forming structure to the entrance of the patient's airways, the gas delivery conduit constructed and arranged to, in use, contact at least an area of ​​the patient's head above the superior ear-base point of the patient's head, the gas delivery conduit including a conduit wall defining a hollow interior for allowing air to flow into the seal-forming structure. The tube wall may include: 1) a non-patient-contacting portion including a first outer layer and a first inner layer including an air-impermeable material; and 2) a patient-contacting portion including a second outer layer configured to be positioned on the opposite side of the gas delivery tube toward the patient's head in use to the first outer layer, and the second inner layer including an air-impermeable material.

[0103] In examples: (a) the first outer layer comprises a woven material; (b) the second outer layer comprises a woven material; (c) the first inner layer comprises a thermoplastic material; (d) the second inner layer comprises a thermoplastic material; (e) the non-patient-contacting portion comprises a first intermediate layer between the first outer layer and the first inner layer; (f) the non-patient-contacting portion comprises a first adhesive layer adhering the first outer layer to the first intermediate layer; (g) the non-patient-contacting portion comprises a second adhesive layer adhering the first intermediate layer to the first inner layer; (h) the first intermediate layer comprises a woven foam material; and (i) (j) the first intermediate layer comprises a spacer fabric, and the first intermediate layer is thicker than the first outer layer; (k) the patient-contacting portion comprises a second intermediate layer between the second outer layer and the second inner layer; (l) the patient-contacting portion comprises a first adhesive layer adhering the second outer layer to the second intermediate layer; (m) the patient-contacting portion comprises a second adhesive layer adhering 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 fabric; and / or (p) the second intermediate layer is thicker than the second outer layer.

[0104] In further examples: (a) the non-patient-contacting portion includes a first adhesive layer adhering the first outer layer to the first inner layer; (b) the patient-contacting portion includes a first adhesive layer adhering the second outer layer to the second inner layer; (c) the patient-contacting portion and / or the non-patient-contacting portion are thermoformed to have a shape; (d) the gas delivery tube includes one of a dome-shaped, trapezoidal, or rectangular cross-section; (e) the width of the gas delivery tube varies along the length of the gas delivery tube from 24 mm to 18 mm; (f) the height of the gas delivery tube varies along the length of the gas delivery tube from 8 mm to 6 mm; and / or (g) the patient-contacting portion and the non-patient-contacting portion are each elongated and include a leading edge and a trailing edge, respectively, wherein the leading edge is joined along the length of the gas delivery tube and the trailing edge is joined along the length of the gas delivery tube.

[0105] In further examples: (a) the leading edge is joined to a leading seam of the gas delivery tube and the trailing edge is joined to a trailing seam of the gas delivery tube; (b) the leading seam and / or the trailing seam are heat formed; (c) the gas delivery tube includes an eyelet configured to connect to a back strap of the positioning and stabilizing structure; (d) the eyelet is formed by the patient-contacting portion and / or the non-patient-contacting portion; and / or (e) the eyelet is formed by a seam connecting the trailing edges of the patient-contacting portion and the non-patient-contacting portion.

[0106] According to another aspect of the present technology, there is provided a positioning and stabilizing structure that provides force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways in use to deliver an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilizing structure may include at least one gas delivery tube for receiving an airflow from above the patient's head and delivering the airflow through the seal-forming structure to the entrance of the patient's airways, the gas delivery tube constructed and arranged to contact at least a region of the patient's head above the superior ear base point in use, the gas delivery tube including a tube wall defining a hollow interior for allowing air to flow to the seal-forming structure. The tube wall may include: 1) an elongated patient-contacting portion configured to be positioned against the patient's head in use; and 2) an elongated non-patient-contacting portion on the gas delivery tube opposite the patient-contacting portion. When the non-patient-contacting portion is forced into a predetermined shape by the patient-contacting portion, a hollow interior of the gas delivery tube is created.

[0107] In examples: (a) the gas delivery tube is biased into an open configuration; (b) the non-patient-contacting portion is biased into a flattened shape; (c) the non-patient-contacting portion is biased by elasticity in one or more materials forming the non-patient-contacting portion; (d) the predetermined shape is a non-flat shape; (e) the gas delivery tube comprises a trapezoidal cross-section; (f) the patient-contacting portion comprises a non-flat shape; (g) the patient-contacting portion comprises a flatter shape than the non-patient-contacting portion; (h) the patient-contacting portion is under tension across the width of the patient-contacting portion; (i) the non-patient-contacting portion is bounded by the patient-contacting portion. (j) the non-patient-contacting portion and the patient-contacting portion are joined at a pair of seams; (k) the patient-contacting portion and the non-patient-contacting portion each include a leading edge and a trailing edge, the leading edge being joined along the length of the gas delivery tube and the trailing edge being joined along the length of the gas delivery tube; (l) the leading edges are joined to form a leading seam for the gas delivery tube and the trailing edges are joined to form a trailing seam for the gas delivery tube; (m) the leading seam and / or the trailing seam are heat formed; and (n) the patient-contacting portion and the non-patient-contacting portion are heat formed.

[0108] In examples: (a) the patient-contacting portion and / or the non-patient-contacting portion includes multiple layers; (b) the patient-contacting portion includes a first outer layer including a fabric or foam material; (c) the non-patient-contacting portion includes a second outer layer including a fabric or foam material; and (d) the patient-contacting portion and / or the non-patient-contacting portion includes an intermediate layer including a foam material or a spacer fabric material.

[0109] In further examples: (a) the patient-contacting portion may be stiffer than the non-patient-contacting portion; (b) the non-patient-contacting portion may be stretchier than the patient-contacting portion; (c) the patient-contacting portion may be thicker than the non-patient-contacting portion; and (d) the patient-contacting portion may include an interior-facing surface configured for placement against the patient's head that has a higher coefficient of friction against the patient's skin than the laterally-facing surface of the non-patient-contacting portion.

[0110] In certain embodiments, the positioning and stabilizing structure includes a pair of gas delivery tubes.

[0111] According to one aspect of the present technology, there is provided a positioning and stabilizing structure that provides force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways in use to hermetically deliver an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout said patient's respiratory cycle. The positioning and stabilizing structure may include at least one gas delivery conduit for receiving an airflow from a connection port on the patient's head and delivering the airflow through the seal-forming structure to the entrance of the patient's airways, the gas delivery conduit constructed and arranged to contact at least an area of ​​the patient's head above the superior ear-base point in use, the gas delivery conduit including a conduit wall defining a hollow interior for allowing air to flow into the seal-forming structure. The tube wall portion may include: 1) a patient-contacting portion including a first outer layer including a fabric or foam material configured to be positioned against the patient's head during use; and 2) a non-patient-contacting portion including a second outer layer including a fabric or foam material on the gas delivery tube opposite the first outer layer.

[0112] In examples, (a) the patient-contacting portion is stiffer than the non-patient-contacting portion; (b) the patient-contacting portion is thicker than the non-patient-contacting portion; (c) the patient-contacting portion is thermoformed by a first heat-forming process and the non-patient-contacting portion is thermoformed by a second heat-forming process, wherein the stiffness imparted to the patient-contacting portion from the first heat-forming process is greater than the stiffness imparted to the non-patient-contacting portion from the second heat-forming process; (d) the patient-contacting portion and the non-patient-contacting portion are each formed by layers, wherein the patient-contacting portion includes more layers than the non-patient-contacting portion; (e) the patient-contacting portion includes a stiffening layer; and (f) the patient-contacting portion includes a stiffening member.

[0113] In further examples, (a) the patient-contacting portion and / or the non-patient-contacting portion may include multiple layers; (b) the patient-contacting portion may include a first thermoplastic inner layer that defines at least a portion of an air path within the gas delivery tube; (c) the patient-contacting portion may include a first intermediate layer between the first outer layer and the first thermoplastic inner layer; (d) the patient-contacting portion may include a first adhesive layer that adheres the first outer layer to the first intermediate layer; (e) the patient-contacting portion may include a second adhesive layer that adheres the first intermediate layer to the first thermoplastic inner layer; and / or (f) the first intermediate layer may be formed from a foam material or a spacer fabric material.

[0114] In further examples: (a) the non-patient-contacting portion may include a second thermoplastic inner layer that defines at least a portion of an air path within the gas delivery tube; (b) the non-patient-contacting portion may include a first adhesive layer that adheres the second outer layer to the second thermoplastic inner layer; (c) alternatively, the non-patient-contacting portion may include a second intermediate layer between the second outer layer and the second thermoplastic inner layer; (d) the patient-contacting portion may include a first adhesive layer that adheres the second outer layer to the second intermediate layer; (e) the patient-contacting portion may include a second adhesive layer that adheres the second intermediate layer to the second thermoplastic inner layer; and / or (f) the second intermediate layer may be formed from a foam material.

[0115] In further examples: (a) the patient-contacting portion and / or the non-patient-contacting portion may be thermoformed to have a shape; (b) the gas delivery tube may include a dome-shaped cross-section; (c) the width of the gas delivery tube may vary within a range of 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 within a range of 8 mm to 6 mm along the length of the gas delivery tube.

[0116] According to another aspect of the present technology, there is provided a positioning and stabilizing structure that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways in use to deliver an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilizing structure may include at least one gas delivery tube for receiving an airflow from above the patient's head and delivering the airflow through the seal-forming structure to the entrance of the patient's airways, the gas delivery tube constructed and arranged to contact at least a region of the patient's head above the superior ear base point in use, the gas delivery tube including a tube wall defining a hollow interior for allowing air to flow to the seal-forming structure. The tube wall may include: 1) a patient-contacting portion configured to be positioned facing the patient's head in use; and 2) a non-patient-contacting portion on the opposite side of the gas delivery tube from the patient-contacting portion.

[0117] In examples: (a) the patient-contacting portion and / or the non-patient-contacting portion may include multiple layers; (b) the patient-contacting portion may include a first outer layer comprising a fabric or foam material; (c) the non-patient-contacting portion may include a second outer layer comprising a fabric or foam material; and (d) the patient-contacting portion and / or the non-patient-contacting portion may include an intermediate layer comprising a foam material or a spacer fabric material.

[0118] 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 with two or more rounded corners; (c) the patient-contacting portion may be stiffer than the non-patient-contacting portion; (d) the non-patient-contacting portion may be more stretchable than the patient-contacting portion; (e) the patient-contacting portion may be thicker-walled than the non-patient-contacting portion; and (f) the patient-contacting portion may include an inward-facing surface configured to be placed against the patient's head that has a higher coefficient of friction against the patient's skin than a laterally-facing surface of the non-patient-contacting portion.

[0119] In further examples: (a) the gas delivery tube may be biased to have an open configuration; (b) the non-patient-contacting portion may be biased to a flat shape and the patient-contacting portion may pull the non-patient-contacting portion into a curved shape, thereby creating a hollow interior of the gas delivery tube; (c) the patient-contacting portion and the non-patient-contacting portion may each be elongated and each may include a leading edge and a trailing edge, where the leading edge is joined along the length of the gas delivery tube and the trailing edge is joined along the length of the gas delivery tube; (d) after the leading and trailing edges are joined, the patient-contacting portion and / or the non-patient-contacting portion may be under tension; (e) when the leading edges are joined, a leading seam for the gas delivery tube may be formed and when the trailing edges are joined, a trailing seam for the gas delivery tube may be formed; (f) when the leading seam is joined, a leading seam for the gas delivery tube may be formed; (g) the front seam may have a different stiffness than the rear seam; (h) the front seam may be stiffer than the rear seam; (i) the stiffness of the front seam and / or rear seam may vary along the length of the gas delivery tube; (j) the stiffness of the front seam and / or rear seam may be higher at the bottom of the gas delivery tube than at the top of the gas delivery tube; (k) the gas delivery tube may include an eyelet configured to connect to a back strap of the positioning and stabilizing structure; (l) the eyelet may be formed by the patient-contacting portion and / or the non-patient-contacting portion; (m) the eyelet may be formed by a seam connecting the rear edges of the patient-contacting portion and the non-patient-contacting portion.

[0120] According to one aspect of the present technology, there is provided a positioning and stabilizing structure that provides force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways in use to hermetically deliver an airflow at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout said patient's respiratory cycle. The positioning and stabilizing structure may include at least one gas delivery conduit for receiving an airflow from a connection port on the patient's head and delivering the airflow through the seal-forming structure to the entrance of the patient's airways, the gas delivery conduit constructed and arranged to contact at least an area of ​​the patient's head above the superior ear-base point in use, the gas delivery conduit including a conduit wall defining a hollow interior for allowing air to flow into the seal-forming structure. The tube wall portion may include: 1) a patient-contacting portion including a first outer layer including a fabric or foam material configured to be positioned against the patient's head during use; and 2) a non-patient-contacting portion including a second outer layer including a fabric or foam material on the gas delivery tube opposite the first outer layer, wherein at least one seam is formed by an edge of the non-patient-contacting portion joined to each edge of the patient-contacting portion.

[0121] In examples: (a) at least one seam provides rigidity to at least one gas delivery tube; (b) at least one seam is formed by a heat-forming process; (c) at least one seam includes rigidity provided by compression of the edges forming the seam during the heat-forming process; and (d) at least one seam is welded.

[0122] In an example: (a) at least one gas delivery pipe includes an upper pipe section and a lower pipe section; (b) the rigidity of at least one seam is higher in the lower pipe section of the gas delivery pipe than in the upper pipe section; (c) the higher rigidity of at least one seam in the lower pipe section is obtained by compressing the edges forming the seam in the lower pipe section more during the heat-forming process than the edges forming the seam in the upper pipe section; (d) at least one seam is thicker in the lower pipe section of the gas delivery pipe; and (e) the width of at least one seam is greater in the lower pipe section of the gas delivery pipe than in the upper pipe section.

[0123] In examples: (a) at least one seam includes a leading seam, where the patient-contacting and non-patient-contacting portions of the gas delivery tube each include a leading edge, and the leading seam is formed when the leading edges of the patient-contacting and non-patient-contacting portions are joined; (b) at least one seam includes a trailing seam, where the patient-contacting and non-patient-contacting portions of the gas delivery tube each include a trailing edge, and the trailing seam is formed when the trailing edges of the patient-contacting and non-patient-contacting portions are joined; (c) at least one seam includes a leading seam and a trailing seam, where the patient-contacting and non-patient-contacting portions of the gas delivery tube each include a leading edge and a trailing edge, and the leading seam is formed when the trailing edges are joined.

[0124] In the example: (a) the front seam is stiffer than the rear seam; (b) the greater stiffness of the front seam is achieved by compressing the edges forming the front seam more than the edges forming the rear seam during the heat-forming process; (c) the front seam is thicker than the rear seam; and (d) the width of the front seam is wider than the width of the rear seam.

[0125] In an example: (a) at least one seam includes a rear seam, wherein the patient-contacting portion and the non-patient-contacting portion of the gas delivery tube each include a rear edge, and when the rear edges of the patient-contacting portion and the non-patient-contacting portion are joined, they form the rear seam; (b) the rear seam includes a widened portion, the widened portion configured to connect with a strap of the positioning and stabilizing structure; (c) the rear seam includes an eyelet configured to connect with the strap; (d) the rear seam includes a hole configured to receive the strap, the hole allowing the strap to pass through the hole and loop back to secure in the hole; (e) the eyelet in the rear seam includes a slit; (f) the positioning and stabilizing structure includes an eyelet stiffening portion configured to reinforce the eyelet; (g) the eyelet stiffening portion is disposed within the hole in the rear seam and configured to reinforce the shape of the hole; and (h) the eyelet stiffening portion is substantially rigid.

[0126] In accordance with one aspect of the present technology, there is provided a patient interface, the patient interface comprising: 1) a pressure of at least 6 cmH above ambient air pressure; 21) a patient interface configured to allow a patient to breathe from the atmosphere through their oral cavity in the absence of pressurized airflow through the plenum chamber inlet port; 2) 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 airways, the seal-forming structure having holes therein whereby the airflow at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use; 3) a positioning and stabilizing structure according to any one of the above aspects; 4) a venting structure for transferring a continuous flow of gases exhaled by the patient from the interior of the plenum chamber to the atmosphere, the venting structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use, the patient interface being configured to allow a patient to breathe from the atmosphere through their oral cavity in the absence of pressurized airflow through the plenum chamber inlet port, or alternatively, the patient interface being configured to leave the patient's oral cavity exposed.

[0127] Another aspect of certain forms of the present technology is a system for treating a respiratory disorder, the system including a patient interface according to any one or more of the other aspects of the present technology, an air circuit, and a source of air at positive pressure.

[0128] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a peripheral shape that is complimentary to the shape of the intended wearer.

[0129] One aspect of one form of the present technology is a method of manufacturing a component of a medical device.

[0130] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured to expose the patient's oral cavity in use.

[0131] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured to prevent any portion of the seal-forming structure from entering the oral cavity during use.

[0132] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured to prevent the seal-forming structure from extending into the patient's airway.

[0133] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured such that, in use, the seal-forming structure does not extend below the mental protuberance area.

[0134] Another aspect of certain forms of the present technology is a patient interface constructed and arranged to expose the patient's eye during use.

[0135] Another aspect of certain forms of the present technology is a patient interface constructed and arranged to allow the patient to breathe ambient air in the event of a power outage.

[0136] Another aspect of certain forms of the present technology is a patient interface that includes a seal-forming structure configured to form a seal on the underside of the patient's nose without contacting the nose bridge region of the patient's nose.

[0137] Another aspect of certain forms of the present technology is a patient interface that includes a vent and a plenum chamber, the patient interface constructed and arranged to allow gas from within the plenum chamber to travel through the vent to the ambient.

[0138] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged to allow the patient to lie comfortably in a side or lateral sleeping position when using the patient interface.

[0139] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged to allow the patient to lie comfortably in a supine sleep position when using the patient interface.

[0140] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged to allow the patient to lie comfortably in a prone sleeping position when using the patient interface.

[0141] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or acumen, or individuals with limited experience using such medical devices.

[0142] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., around the home).

[0143] An aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, for example with soap and water, without the need for special cleaning equipment.

[0144] Of course, some of the above aspects may form sub-aspects of the present technology, and various sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0145] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.

[0146] The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include like elements: 4.1 Treatment system Figures 1A to 1C 4.2 Respiratory System and Facial Anatomy Figures 2A-2L 4.3 Patient Interface Figures 3A to 30 4.4 RPT Device Figures 31A to 31C 4.5 Humidifier Figures 32A to 32B [Brief explanation of the drawings]

[0147] [Figure 1A] A system is shown including a patient 1000 wearing a patient interface 3000, which takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleeping position. [Figure 1B] A system is shown including a patient 1000 wearing a patient interface 3000, which takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a supply of positive pressure air from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleeping position. [Figure 2A] An outline of the human respiratory system including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B]Diagram of the human upper respiratory tract including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, esophagus, and trachea. [Figure 2C] A front view of the face including several features of the surface anatomy including upper lip, vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and corners of the mouth. The superior, inferior, radially inward, and radially outward directions are also indicated. [Figure 2D] A lateral view of the head including several features of the surface anatomy, including the glabella, serrion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior ear base points. The directions of superior and inferior, and anterior and posterior are also indicated. [Figure 2E]

[0023] Figure 1 is a further lateral view of the head, showing the approximate locations of the Frankfort horizontal and nasolabial angle. The coronal view is also shown. [Figure 2F] A bottom view of the nose including several features including the nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, major axis of the nostrils and midsagittal plane. [Figure 2G] FIG. 1 is a side view of the surface features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose, including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibro-adipose tissue. [Figure 2I] The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention paid to the nasal septum cartilage and the medial crus of the greater alar cartilage. [Figure 2J] A bony frontal view of the skull including the frontal, nasal and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 2K] Side view of the skull, showing the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius. [Figure 2L] Shows the anterolateral aspect of the nose. [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point has a positive sign and a relatively large magnitude compared to the magnitude of the curvature shown in 3C. [Figure 3C] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] Schematic cross-section of a structure cut at a point, where the outward normal at this point is shown and the curvature value at this point is zero. [Figure 3E] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point. The curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. 3F. [Figure 3F] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3G] 1 shows a mask cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome region and saddle region are shown. [Figure 3H] 1 shows a cushion for a mask. The outer surface of the cushion is shown. The edge of the surface is shown. The path on the surface between points A and B is shown. The linear distance between A and B is shown. Two saddle regions and a dome region are shown. [Figure 3I] The surface of a structure is shown, with a one-dimensional hole drilled into the surface. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] 3B is a cross-sectional view through the structure of Figure 3I. The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. 3I are also shown. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] 3L is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left-hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] The right ear is shown, including the right ear helix. [Figure 3S] Shows a right-handed spiral. [Figure 3T] 1 is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] A view of the plenum chamber 3200 showing the midsagittal plane and the central contact plane. [Figure 3V] A posterior view of the plenum chamber of Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 3V, the midsagittal plane bisects the plenum chamber into a left-hand side and a right-hand side. [Figure 3W] 3V is a cross-sectional view through the plenum chamber of FIG. 3V, where the cross-section is taken in the midsagittal plane shown in FIG. 3V. The "central contact" plane is shown. The central contact plane is perpendicular to the midsagittal plane. The orientation of the central contact plane corresponds to the orientation of the tendon 3210. The tendon 3210 rests on the midsagittal plane and contacts the cushion of the plenum chamber only at two points on the midsagittal plane (i.e., superior point 3220 and inferior point 3230). Depending on the geometry of the cushion in this region, the central contact plane may contact both the superior and inferior points. [Figure 3X]The plenum chamber 3200 of Figure 3U is shown in a use position on the face. The midsagittal plane of the plenum chamber 3200 generally coincides with the midsagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face plane" when the plenum chamber is in the use position. In Figure 3X, the plenum chamber 3200 is that of a nasal mask, with the upper point 3220 resting approximately on the selion and the lower point 3230 resting on the upper lip. [Figure 4A] FIG. 10 is an isometric view of a patient interface in accordance with an example of the present technology. [Figure 4B] FIG. 1 is an isometric view of a patient interface being worn by a patient. [Figure 4C] FIG. 1 is a side view of a patient interface being worn by a patient. [Figure 4D] FIG. 10 is a top view of a patient interface being worn by a patient. [Figure 4E] FIG. 10 is an isometric view of the patient interface tube placed on a flat surface in a planar configuration. [Figure 4F] FIG. 1 is an isometric cross-sectional view of a portion of a tube. [Figure 4F-1] 1 shows an enlarged section of the tube layer. [Figure 4F-2] 1 shows an enlarged section of the tube layer. [Figure 4G] FIG. 4D is a cross-sectional view of a portion of the patient interface shown in FIG. 4C. [Figure 4H] FIG. 4D is a cross-sectional view of a portion of the patient interface shown in FIG. 4C. [Figure 4I] 10 illustrates possible cross-sectional shapes for the patient interface tube. [Figure 4J] 10 illustrates another possible cross-sectional shape for the patient interface tube. [Figure 4K] 10 illustrates another possible cross-sectional shape for the patient interface tube. [Figure 4L-1] 1 is an isometric view of a tube in a given three-dimensional configuration. [Figure 4L-2] FIG. 1 is a side view of a tube frame. [Figure 4L-3] FIG. 1 is a front view of the tube frame. [Figure 4L-4] FIG. 1 is a top view of the tube frame. [Figure 4M] FIG. 1 is an isometric cross-sectional view of a connection port in a tube. [Figure 4N] FIG. 1 is an isometric view of the connection ports separated. [Figure 4O] FIG. 10 is an isometric view of another form of connection. [Figure 4P] The connection between the mask and the tubing is shown. [Figure 4Q] 10 shows an alternative configuration of connector for attaching the mask to the tubing. [Figure 4R] FIG. 10 is an isometric view of a patient interface according to an embodiment of the present technology as it is being applied to a patient. [Figure 4S] FIG. 10 is a perspective view of a patient interface according to another embodiment of the disclosed technology; [Figure 4T] FIG. 10 is a front perspective view of an upper connector of a positioning and stabilizing structure in accordance with one embodiment of the disclosed technology. [Figure 4U] FIG. 10 is a side perspective view of a lower connector of a positioning and stabilizing structure in accordance with an embodiment of the disclosed technology. [Figure 4V] 4S shows a cross section of the positioning and stabilizing structure of FIG. [Figure 4W] 10 shows a cross section of an outer layer of a positioning and stabilizing structure in accordance with another example of the disclosed technology. [Figure 4X] FIG. 10 is a perspective view of a patient interface according to another embodiment of the disclosed technology; [Figure 5A] 10 shows a diagram of the straps of the patient interface. [Figure 5B] 1 shows a side view of a portion of a strap. [Figure 5C] A partial exploded view of a portion of the strap 3420 is shown. [Figure 5D] 1 shows a portion of a strap in an untensioned and tensioned state. [Figure 5E] 1 shows a portion of a strap in an untensioned and tensioned state. [Figure 5F] 10 shows an alternative patient interface including an alternative head strap. [Figure 5G] FIG. 5F is a top view showing the head strap separately. [Figure 5H] FIG. 1 is an exploded isometric view of a head strap. [Figure 6A] 1 shows an isometric top view of a seal-forming structure utilized in a patient interface. [Figure 6B] FIG. 10 shows an isometric bottom view of the seal-forming structure of the patient interface. [Figure 6C] 1 shows an isometric view of the sealing layer of the seal-forming structure. [Figure 6D] 1 shows a cross-sectional isometric view of the sealing layer. [Figure 6D-1] FIG. 2 is an enlarged view of a portion of the sealing layer. [Figure 6E] 1 shows a seal-forming structure attached to the frame. [Figure 7A] 1 shows a mold used in forming the sealing layer. [Figure 7B] 1 shows a fabric sheet positioned to engage a mold. [Figure 7C] 1 shows how a fabric sheet adjacent to the mold is spread over the mold by a roller. [Figure 7D] 1 shows a woven sheet pressed into the shape of a mold. [Figure 7E] 1 shows a membrane layer being applied to a fabric sheet in a mold. [Figure 7F] This shows how heat is applied to the film layer. [Figure 7G] 1 shows the removal of the hardened layer from the mold. [Figure 7H] 1 shows how the sealing layer is cut to give it shape. [Figure 7I] 1 shows a planar sheet that has been pre-cut before being inserted into a mold. [Figure 7J] 1 shows the sheet after it has been added into the mold. [Figure 8A] 1 shows the sheet positioned onto a mold for tube formation. [Figure 8B] 1 shows the sheet in the mold. [Figure 8C]10 shows the positioning of a membrane layer to interact with a sheet within a mold. [Figure 8D] 1 shows the film layer being heated so that it hardens and assumes the shape of the mold. [Figure 8E] Shows how to attach two hardened sheets together. [Figure 8F] 1 shows a section of a tube formed from two sheets. [Figure 8G] 1 shows the sheet positioned on the template information. [Figure 8H] 1 shows the spraying of a membrane layer onto the sheet while it is in the mold. [Figure 8I] 1 shows the sheet and membrane layers in the mold. [Figure 8J] 1 shows the hardened layer being removed from the mold. [Figure 8K] Shown is a tube formed from two cured layers. [Figure 8L] 10 illustrates another method of forming a tube for use in a patient interface. [Figure 8M] 10 illustrates another method of forming a tube for use in a patient interface. [Figure 9A] 10 illustrates a method for forming a tube of another configuration. [Figure 9B] 10 illustrates a method for forming a tube of another configuration. [Figure 9C] An alternative form of tube 3450 is shown. [Figure 9D] FIG. 9C shows a cross section of a tube 3450 in an inflated and uninflated state. [Figure 9E] FIG. 9C shows a cross section of a tube 3450 in an inflated and uninflated state. [Figure 10] 90 shows a perspective view of a patient interface 9000 according to an embodiment of the present technology. [Figure 11]

[0033] Fig. 10 shows a perspective view of a patient interface 10000 according to another embodiment of the present technology. [Figure 12A] FIG. 13 is a detailed view of a headgear tube connector according to an embodiment of the present technology. [Figure 12B] FIG. 13 is a detailed view of a headgear tube connector according to an embodiment of the present technology. [Figure 13] A perspective view of a gas delivery tube 9350 of a patient interface 9000 in accordance with another embodiment of the present technology. [Figure 14] 12 shows a cross-sectional view of the gas delivery tube 9350 of FIG. 11. [Figure 15] 93A shows a cross-sectional view of a gas delivery tube 9350 in accordance with another embodiment of the present technology. [Figure 16] 93 shows an illustration of a cross-sectional view of a gas delivery tube 9350 in accordance with another embodiment of the present technology. [Figure 17] FIG. 9 shows an illustration of a cross-sectional view of a non-patient contacting portion 9349 of a gas delivery tube in accordance with another embodiment of the present technology. [Figure 18]

[0093] Fig. 90 shows a side view of a patient interface 9000 according to another embodiment of the present technology. [Figure 19] 90 shows a perspective view of a patient interface 9000 according to another embodiment of the present technology. [Figure 20] 90 shows a perspective view of a patient interface 9000 according to another embodiment of the present technology. [Figure 21] FIG. 21 is a left side view of the patient interface 9000 of FIG. [Figure 22] FIG. 21 is a right side view of the patient interface 9000 of FIG. [Figure 23] FIG. 21 is a front view of the patient interface 9000 of FIG. [Figure 24] FIG. 21 is a front view of the elbow 9610 and crown connector 9360 of the patient interface 9000 of FIG. [Figure 25] FIG. 21 is a perspective view of the crown connector 9360 of the patient interface 9000 of FIG. [Figure 26] FIG. 21 is a perspective view of the headgear tube 9350 of the patient interface 9000 of FIG. [Figure 27] FIG. 21 is a perspective view of the upper tube portion 9304 of the headgear tube 9350 of the patient interface 9000 of FIG. [Figure 28] FIG. 21 is a perspective view of the lower tube portion 9363 of the headgear tube 9350 of the patient interface 9000 of FIG. [Figure 29]FIG. 21 is a perspective view of the upper tube portion 9304 of the headgear tube 9350 of the patient interface 9000 of FIG. 20, with several forces labeled. [Figure 30] 20. The tab 3320 of the headgear tube 3350 of the patient interface 3000 of FIG. 20 is shown. [Figure 31A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 31B] 1 is a schematic diagram of an air circuit of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are indicated relative to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items located in the air pressure path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 31C] FIG. 1 is a schematic diagram of the electrical components of an RPT device in accordance with one aspect of the present technology. [Figure 32A] FIG. 10 is an isometric view of a humidifier in accordance with one form of the present technology. [Figure 32B] FIG. 10 is an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. DETAILED DESCRIPTION OF THE INVENTION

[0148] 5 Detailed Description of the Embodiments of the Present Technology Before describing the present technology in further detail, it is to be understood that the present technology is not limited to the specific embodiments described herein, which may vary. It is also to be understood that the terminology used in the present disclosure is for the purpose of describing the specific embodiments described herein, and is not intended to be limiting.

[0149] The following description is provided in connection with various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these embodiments may constitute an additional embodiment.

[0150] 5.1 Treatment In one form, the present technology includes a method of treating a respiratory disorder, the method including applying positive pressure to the entrance of the airways of a patient 1000.

[0151] In certain embodiments of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0152] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.

[0153] 5.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of disordered breathing. The apparatus or device may include an RPT device 4000 that supplies pressurized air to the patient 1000 via an air circuit 4170 to a patient interface 3000.

[0154] 5.3 Patient Interface 3A , a non-invasive patient interface 3000 in accordance with one aspect of the present technology includes the following functional features: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional features may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional features. In use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airways to facilitate the delivery of air at positive pressure to the airways.

[0155] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0156] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.

[0157] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.

[0158] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient.

[0159] 5.3.1 Seal formation structure In one form of the present technology, a seal-forming structure 3100 provides a targeted seal-forming area and may further provide a cushioning function.

[0160] The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient during a given treatment session and from day to day, depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0161] In one form, the target seal-forming area is disposed on an exterior surface of the seal-forming structure 3100. The seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material (e.g., silicone or other biocompatible material).

[0162] In one form, the seal-forming structure includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum chamber 3200 by acting on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0163] In one form, the seal-forming structure may include a compression seal or gasket seal that is constructed and arranged to be in compression in use due to, for example, elastic tension in the positioning and stabilizing structure.

[0164] In one form, the seal-forming structure includes a tensioning portion that, in use, is held taut by, for example, an adjacent region of the sealing flange.

[0165] In one form, the seal-forming structure includes an area having a sticky or adhesive surface.

[0166] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension section, and a section having a sticky or adhesive surface.

[0167] The seal-forming structure 3100 may be non-invasive (i.e., does not extend into the patient's airway). In some forms of the present technology, no part of the seal-forming structure 3100 enters the patient's mouth when in use. In some forms of the present technology, the seal-forming structure 3100 is configured to leave the patient's mouth exposed when in use. In some forms of the present technology, the seal-forming structure 3100 does not cover the patient's eyes when in use.

[0168] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange comprises a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the edge length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange and the peripheral edge of the plenum chamber 3200 and extends around at least a portion of the edge length. The support flange is or includes a spring-like element that functions to support the sealing flange against buckling during use. In use, the sealing flange can readily respond to system pressure in the plenum chamber 3200 by acting on its underside to form a tight sealing engagement with a surface.

[0169] In another aspect, the seal-forming portion of the non-invasive patient interface includes a pair of nasal puffs or nasal pillows. Each nasal puff or nasal pillow is constructed and arranged to form a seal with a respective nostril of the patient's nose. The nasal pillows according to one aspect of the present technology include a truncated cone. At least a portion of the truncated cone forms a seal over the underside of the patient's nose, a stem, and a flexible region on the underside of the truncated cone, connecting the truncated cone to the stem. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent the base of the stem. The flexible region can function to facilitate a flexible joint structure. The flexible joint structure accommodates both the displacement and angle of the truncated cone and the relative movement of the structure to which the nasal pillows are connected. For example, the truncated cone can be displaced axially toward the structure to which the stem is connected.

[0170] In one form, the seal-forming structure is configured to form a seal with the underside of the nose around the nostrils and optionally the upper lip in use. This type of seal-forming structure may also be referred to as a "nasal cradle cushion" or "under-the-nose mask" (e.g., such as the seal-forming structure 3100 of the non-invasive patient interface 3000). The shape of the seal-forming structure may be configured to conform to or closely follow the underside of the patient's nose (i.e., the profile and angle of the seal-forming structure may be substantially parallel to the patient's nasal-labial angle). In one form of the nasal cradle cushion, the seal-forming structure includes a septum member defining two orifices. Each of these two orifices delivers air or breathable gas to a different one of the patient's nares in use. The septum member may be configured to contact or seal against the bridge of the patient's nose in use. In some forms of the present technology, the seal-forming structure 3100 is configured to form a seal with the underside of the patient's nose without contacting the nose bridge region of the patient's nose. A nasal cradle interface 3000 is also shown, for example, in Figures 4A-4D, 10, and 11. In some examples, the patient interface may include a seal-forming structure 9100 in the form of a cradle cushion as described in PCT Publication No. WO2018 / 176094, filed March 29, 2018, which is incorporated herein by reference in its entirety.

[0171] In one form, the non-invasive patient interface 3000 includes a seal-forming portion that forms a seal on the upper lip region (i.e., upper lip) of the patient's face, such as the patient interface 3000 shown in FIG. 1B. This seal-forming portion delivers an air supply or breathable gas to both nostrils of the patient 1000 through a single orifice. This type of seal-forming structure may also be referred to as a "nasal cushion" or "nasal mask." In some embodiments of the present technology, positioning and stabilizing structures may be utilized to hold the nasal cushion in a sealing position on the patient's face.

[0172] In one form, the non-invasive patient interface 3000 includes a seal-forming portion that forms a seal over the chin, nose bridge, and cheek regions of the patient's face, such as the patient interface 3000 shown in FIG. 1C. This seal-forming portion delivers an air supply or breathable gas to both nostrils and the oral cavity of the patient 1000 through a single orifice. This type of seal-forming structure may also be referred to as a "full face mask." In some embodiments of the present technology, positioning and stabilizing structures may be utilized to hold the full face cushion in a sealing position on the patient's face.

[0173] In another form, the patient interface 3000 includes a nasal seal-forming structure and an oral seal-forming structure. The nasal seal-forming structure takes the form of a nasal cushion or nasal cradle cushion, and the oral seal-forming structure is configured to form a seal around the patient's oral cavity in use (this may also be referred to as an "oral cushion" or "oral mask"). In such a mask, air or breathable gas is supplied to the patient's nares and the patient's oral cavity through separate orifices in use. This type of seal-forming structure 3100 may be referred to as an "oral-nasal cushion" or an "ultra-compact full-face cushion." In one form, the nasal seal-forming structure and the oral seal-forming structure are integrally formed as a single component. In some examples, the patient interface may include a seal-forming structure in the form of a cradle cushion as described in U.S. Patent Application No. 62 / 649,376 (corresponding PCT Application No. PCT / AU2019 / 050278, filed March 28, 2019), which is incorporated by reference in its entirety. In some examples of the present technology, the positioning and stabilizing structure of the patient interface may be used to hold the oral-nasal cushion in a sealing position on the patient's face.

[0174] In some embodiments of the present technology, the plenum chamber 3200 has a perimeter shaped to be complementary to the surface contours of an average human face in the area where a seal is formed in use. In use, the peripheral edge of the plenum chamber is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure. The seal-forming structure may extend around the entire perimeter of the plenum chamber in use. In some forms, the plenum chamber and the seal-forming structure are formed from a single, homogenous piece of material.

[0175] In some forms of the present technology, the plenum chamber does not cover the patient's eye during use. In other words, the eye is outside the pressurized space defined by the plenum chamber. Such forms can often be less intrusive and / or more comfortable for the wearer, which can improve treatment compliance.

[0176] In certain forms of the present technology, the plenum chamber is constructed from a transparent material (e.g., clear polycarbonate). The use of a transparent material may reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of a transparent material may help the clinician see the placement and function of the patient interface.

[0177] In certain forms of the present technology, the plenum chamber is constructed from a translucent material, which can make the patient interface less intrusive and help improve compliance with treatment.

[0178] In some forms of the present technology, the seal-forming structure 3100 is configured such that, in use, the seal-forming structure does not extend below the mental protuberance area of ​​the patient's head.

[0179] Unless otherwise specified, embodiments of patient interfaces according to the present technology may include any of the above types of seal-forming structures.

[0180] 5.3.2 Seal formation structure In some forms of the present technology, the seal-forming structure 3100 (also referred to as a cushioning structure, conforming structure, or interfacing structure) is constructed from a fabric or textile material. For example, the seal-forming structure 3100 can be woven, nonwoven, knit, or any other textile network. Using a seal-forming structure 3100 constructed from a textile material can lead to improved comfort and feel of the seal-forming structure against the patient's face. Improved comfort can increase the likelihood that a patient will continue to use the device to receive treatment.

[0181] The sealing structure can be used to form a surface that presses against the patient's face for air delivery to the patient's nose and / or mouth. Some patients appreciate the feel of a fabric material against their face as opposed to silicone or other materials. The sealing structure can be formed using similar techniques and methods as described later in this detailed description with reference to the tubing and air delivery system. For example, a cut-and-seal method or a deposition method can be used.

[0182] In use, such techniques can form a variety of components. In some configurations, the mask component of the treatment device can be formed using a deposition method of manufacturing. In one configuration, a release agent is placed on a mold. The layer to be used in the mask is then placed in the mold. The layer can be formed from a variety of materials. In some configurations, the layer can be a cloth-type material. In other configurations, the layer can be plastic, thermoplastic, rubber, silicone, or other bendable or flexible material.

[0183] 6A and 6B, a woven seal-forming structure is illustrated. As shown, the seal-forming structure 3100 includes a sealing layer 3102 and a base 3104. The sealing layer 3102 can be secured to the base 3104 so that the entire seal-forming structure 3100 can be attached to a receiving receptacle 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 predefined three-dimensional shape is defined by the geometric locations of various portions of the sealing layer 3102 (rather than the thickness of the material forming the sealing layer 3102). For example, the material used to bend the sealing layer 3102 to form various planes can be configured to maintain its shape within these various planes.

[0184] As shown in FIGS. 6A-6E, the sealing layer 3102 can be configured to interact with and engage specifically with the patient's nasal region. When worn by a patient, the upper surface of the sealing layer 3102 can be configured to engage specific regions of the patient's face. For example, the regions adjacent the first nostril opening 3108 and the second nostril opening 3110 can be configured to engage with the patient's alae, while the saddle region 3109 can be spaced from the patient's bridge of the nose. Additionally, the nasolabial fold engaging region 3106 can be shaped to engage with the patient's nasolabial fold. Furthermore, the configuration of the seal-forming structure 3100 allows the patient to breathe through their mouth (without pressurized air passing through the patient's mouth) because the seal-forming structure 3100 is configured to unobstruct the patient's mouth. Furthermore, as shown in FIGS. 6A-6E, the sealing layer 3102 is configured such that the sealing layer 3102 does not extend beyond the bridge of the nose. For example, in use, at least the lateral nasal cartilages, nasal bone and nasal septum cartilage are not covered by the sealing layer 3102 (see FIG. 2L).

[0185] In some embodiments, air pressure is not required to maintain the shape of the sealing layer 3102, but rather portions of the sealing layer 3102 may be enhanced by air pressure to contribute to a good seal between the sealing layer 3102 and the patient's face. For example, in some embodiments, a bellows-like portion of the sealing layer 3102 may be formed adjacent the base 3104. When pressurized, the bellows may expand, thereby providing further sealing pressure between the sealing layer 3102 and the patient's face. Additionally, other portions of the sealing layer 3102 may be configured to expand to engage particular areas of the patient's face (e.g., the nasolabial folds).

[0186] The sealing layer 3102 may be deformable so that when pressed against it by a normal amount of force from the patient interface 3000, the sealing layer 3102 will deform. The sealing layer 3102 may conform to the shape of various areas of the patient's face, thereby minimizing air leakage. After being removed from the patient's face, the sealing layer 3102 may elastically return to its undeformed shape. That is, because the sealing layer 3102 has a three-dimensional shape when not pressed against it, the sealing layer 3102 will recover after force is released from the sealing layer 3102.

[0187] The sealing layer 3102 may be formed from a variety of layers, resulting in a laminate structure. Each of these layers may impart specific properties to the sealing layer 3102. In one form of the present technology, the sealing layer 3102 comprises a thermoplastic or thermosetting material. This material is capable of maintaining a specific shape when cured. For example, in one form, the sealing layer 3102 may comprise a thermosetting material, such as a foam material. This thermosetting material may conform to the shape of a mold and retain the shape of the mold, as shown in Figures 7A-7H.

[0188] The sealing layer 3102 may be configured to press against specific regions of the nose or nasal region. For example, the nasolabial fold region 3106 may be configured to press against the patient's nasolabial fold region. Additionally, other regions of the sealing layer 3102 may be specifically shaped to correspond to the patient's shape. The sealing layer 3102 includes a first nostril opening 3108 and a second nostril opening 3110 configured to align with the patient's respective nostrils. Additionally, the sealing layer 3102 includes a saddle region 3109 disposed between the first nostril opening 3108 and the second nostril opening 3110, respectively. The saddle region 3109 extends away from the bridge of the user's nose in use, thereby spacing the sealing layer 3102 material from the patient's nose for increased comfort.

[0189] The sealing layer 3102 may be shaped to space the surface that seals against the patient's face from the base 3104. Spaced apart from the base 3104, the sealing layer 3102 may provide a cushioning or buffer zone between the softer surface of the sealing layer 3102 and the rigid composition of the base 3104. For example, as shown in FIG. 6D , the height 3111 of the sealing layer 3102 spaces the engaging surface of the sealing layer 3102 from other components of the patient interface 3000. In addition to the height 3111, the sealing layer 3102 may have various regions with positive and negative curvature, saddle regions, hemispherical shapes, and other configurations, as shown throughout the figures. The sealing layer's particular shape may be formed to engage with the patient's airway. These particular shapes may be formed using a mold, complex shapes, or other techniques as described herein.

[0190] In some embodiments, the first nostril opening 3108 and the second nostril opening 3110 may be raised from the surrounding surface. That is, in some embodiments, flanges 3107 included in the material surrounding the first nostril opening 3108 and the second nostril opening 3110 extend from the surface of the sealing layer 3102 toward the user's nasal passages. By raising certain areas of the sealing layer 3102, a better or more secure fit can be achieved compared to other techniques. For example, the first nostril opening 3108 and the second nostril opening 3110 may engage the nasal wall corresponding to the columella, ala, or other portion of the nasal opening. The flanges 3107 may provide stability, restricting the first nostril opening 3108 from pressing against the second nostril opening 3110 and moving away from the nasal opening. This alignment provided by the first nostril opening 3108 and the second nostril opening 3110 can provide consistency in oxygenation to the patient. In some forms, the shape of the first nostril opening 3108 and the second nostril opening 3110 can have a substantially frusto-conical shape. In other forms, the shape of the opening can have a vertically extending flange 3107 instead of tapering like a frusto-conical shape. In still other forms, the shape of the opening can be formed to engage with the inner surface of the nasal opening. In still other forms, the material around the first nostril opening 3108 and the second nostril opening 3110 can be evenly aligned with the material around the sealing layer 3102.

[0191] Additionally, the height or depth of the flanges 3107 of the first nostril opening 3108 and the second nostril opening 3110 can be specifically configured. Some patients prefer a configuration in which the openings extend a greater distance into the patient's nostrils (than others). As such, the depth of the flanges 3107 of the first nostril opening 3108 and the second nostril opening 3110 can be adjusted depending on the patient's or medical professional's preference. The flanges 3107 can be formed in the same manner as the rest of the seal-forming structure 3102, since foam or thermosetting materials can be used to maintain the flange shape without air pressure or other rigid mold materials. The nostril shape can also depend on the shape of the mold used to form the sealing layer 102, as shown in FIGS. 7A-7H.

[0192] In some forms, the sealing layer 3102 can be specifically positioned to include areas of greater or lesser stiffness to accommodate specific areas of the patient. The sealing layer 3102 can include a more rigid or hard section along the nasolabial fold region 3106 (where the sealing layer 3102 is configured to engage the patient's nasolabial fold). Because this facial region is less sensitive than other facial regions, thicker or more rigid sections can be utilized to provide a robust structure for sealing. Other regions of the sealing layer 3102 can include a more flexible or less rigid structure. For example, the flange 3107 of the sealing layer 3102, which may contact the bridge of the patient's nose, can be made less rigid so as not to interfere with the patient.

[0193] In some forms, the stiffness or rigidity of the sealing layer 3102 can be modified or determined by the amount or quantity of membrane material (e.g., thermoplastic material applied onto the inner surface of the sealing layer 3102). In other forms, the stiffness or rigidity of the sealing layer 3102 can be determined based on the quantity of material used. For example, in some forms, the sealing layer 3102 includes bends or folds that increase the thickness or density of the sealing layer 3102 in certain locations. Thus, by folding the material of the sealing layer 3102 in a particular manner, additional membrane material or support can be eliminated to form rigid regions of the sealing layer 3102.

[0194] The sealing layer 3102 may be secured to the base 3104. The base 3104 may include a clip, allowing for easy removal of the seal-forming structure 3100 from a receiving receptacle, such as the frame 3152 of the patient interface 3000 (see, e.g., FIG. 6E). Additionally, the base 3104 may be harder or more rigid than the sealing layer 3102, which may allow the base 3104 to bear along the edges of the sealing layer 3102, thereby holding the sides of the sealing layer 3102 in a fixed position when the sealing layer 3102 of the seal-forming structure 3100 is compressed.

[0195] Additionally, other configurations of the sealing layer 3102 may be used. For example, in some configurations, a full mask may be used rather than a sealing structure that only supplies air to the nose. In other configurations, a mask that only supplies air to the mouth may be used. Various configurations may be used. For example, in some configurations, a single hole or aperture may be used instead of separate holes for each nostril. Furthermore, in some configurations, the sealing structure may be designed to receive the nose, while in other designs, the sealing structure may be designed to be adjacent to the nasal surface (without enclosing or surrounding the nose). Furthermore, the mask or sealing structure may be designed for specific comfort. For example, in some configurations, a nasal mask may be designed to space the patient's tip or nasal tip from the mask. Because the nasal tip is typically a sensitive area of ​​the nose, designing the mask to space the nasal tip from the mask may increase patient comfort.

[0196] A cross section of the sealing layer 3102 is illustrated in FIG. 6D , and an enlarged view of a portion of the sealing layer 3102 is shown in FIG. 6D-1 . As shown, a membrane layer 3118 is disposed along the inner surface of the sealing layer 3102. A fabric sheet 3116 is disposed along the opposite lower surface of the sealing layer 3102. The thickness of the membrane layer 3118 can be determined or changed during the manufacturing process depending on 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 conform to the patient's face. In some embodiments, the thickness of the sealing layer 3102 is determined only by the thickness of the membrane layer 3118 and the fabric sheet 3116. That is, in some embodiments, no additional components (e.g., stiffeners) are used to maintain the shape of the sealing layer 3102. For example, the sealing layer 3102 can be easily deformed along the entire portion of the sealing layer 3102 .

[0197] As noted above, the nasolabial fold engagement region 3107 may have a different thickness of material than adjacent portions of the sealing layer 3102. For example, a greater amount of membrane layer may be added along the inner surface of the sealing layer 3102 in the nasolabial fold engagement region 3107. Such additional material allows for an increase in the thickness and stiffness of the nasolabial fold engagement region 3107.

[0198] In addition to providing structure and support for the sealing layer 3102, the membrane layer 3118 may also contain air within the sealing layer 3102. That is, in some embodiments, the membrane layer 3118 may prevent air from passing through the material of the sealing layer 3102. As such, the membrane layer 3118 may direct air from the treatment device toward the nostril openings of the sealing layer 3102 and the patient. Furthermore, as described below in other embodiments, the sealing layer 3102 may be designed to achieve a specific leakage rate, which may eliminate the need for a separate bleed or leak valve. This feature may therefore reduce manufacturing costs by removing a component from the treatment device.

[0199] In some forms, the membrane layer 3118 can be a fusible material (e.g., a thermoplastic or thermosetting material). This material can assume a certain shape when melted into a mold or other form. As described later in this specification and shown in Figures 7A-7H, the membrane layer 3118 can be melted or partially melted (e.g., become tacky), allowing the material to conform to a particular shape. After melting, the membrane layer 3118 can be hardened into a shape (e.g., the shape of the mold). After hardening, the membrane layer 3118 assumes the shape of the mold, so the membrane layer 3118 has a predetermined shape. The membrane layer 3118 imparts a shape to any material to which it is laminated or adhered. For example, the membrane layer 3118 can enable the textile sheet 3116 to assume the same shape as the membrane layer 3118 because the membrane layer 3118 is fixed together with the textile sheet 3116 due to its ability to conform to various shapes. The fabric sheet 3116 may also include properties such that the fabric sheet 3116 includes areas that are shape-conforming after fusing. The amount of pressure required to temporarily change the shape of the sealing layer 3102 laminate may depend on the thickness of the membrane layer 3118 and the material from which the membrane layer 3118 is formed.

[0200] In some forms of the present technology, the membrane layer 3118 may be formed from a thermosetting material. Additionally, the sealing layer 3102 may include an additional laminate layer formed from a thermosetting material. An example of a thermosetting material is a foam material. A laminate using a thermosetting material may be heated after being placed in a mold. Thermosetting materials can be cured in a manner similar to thermoplastic materials. That is, thermosetting materials can be heated and, in contrast to thermoplastic materials, can be irreversibly cured into a specific shape. Thermosetting materials may be used when a more rigid or permanent structure is desired. The flexibility and rigidity of components such as the sealing layer 3102 can be adjusted based on the material selected and the thickness of the thermosetting material. Because a thermosetting material can be cured into a specific shape, when used as a laminate with the sealing layer 3102, the shape of the sealing layer 3102 can also be formed into a specific shape.

[0201] 4P, the sealing layer 3102, along with the base 3104 and frame 3152, can be placed into a mask and air delivery system for use in treatment. As shown, the base 3104 can be attached during assembly to a connection port 3154. The assembly connection port 3154 can provide air distribution to the sealing layer 3102 through a tube 3350.

[0202] The sealing layer 3102 may be lighter than other forms of technology and may also provide greater comfort to the patient than other forms of technology. Furthermore, woven sheets, such as the woven fabric sheet 3116, can be stored in a flat or planar form, thereby reducing material storage costs. Furthermore, the use of a mold 3112 (see FIGS. 7A-7G) allows for the formation of complex shapes, such as the sealing layer 3102, while reducing costs. Instead of using injection molding or extrusion, which require multiple complex pieces and equipment, a deposition process involving a mold, such as the mold 3112, allows for a simplified process that can reduce manufacturing time and costs. Furthermore, complex shapes may be formed relatively easily.

[0203] Additionally, in some forms, the membrane layer 3118 used in forming the sealing layer 3102 may be the same material as that used in forming the woven tubing as described later herein. The use of the same material may allow for bulk purchasing of large quantities of material, thereby reducing the cost of producing various components.

[0204] Referring to FIG. 4Q, a possible assembly of a portion of tubing configured to interact with the seal-forming structure 3100 is illustrated. As shown, an assembly connection port 3154 is secured between the layers of the tubing. The assembly connection port 3154 is sandwiched between an inner textile layer 3452 and an outer textile layer 3454. Additionally, the assembly connection port 3154 extends through the outer foam material layer 3456. In this configuration, an air passageway or air conduit is formed between the inner textile layer 3452 and the outer textile layer 3454, and the assembly connection port 3154 is used to transfer air from the air passageway through the outer foam material layer 3456. In this manner, the assembly connection port 3154 is secured by the inner textile layer 3452 and the outer textile layer 3454. Air can then be supplied to the patient by snap-fitting, friction-fitting, or otherwise securing the connection port 3154 to the frame 3152.

[0205] 5.3.2.1 Method of forming seal-forming structure 7A-7J, one method of forming the sealing structure is shown. In FIG. 7A, a mold 3112 includes a receiving portion 3114. The receiving portion 3114 may take the shape of a sealing surface used with a full face mask, nasal mask, or other mask such as used in a treatment device.

[0206] 7B and 7C, a woven fabric sheet 3116 is placed on the mold 3112. The woven fabric sheet 3116 may be formed of materials such as cotton, polyester, rayon, or other materials or combinations of materials. Furthermore, the woven fabric sheet 3116 may be formed in the same configuration as the sheets described in more detail below (e.g., the inner layer 3352 and the outer layer 3426). That is, the woven fabric sheet 3116 may be woven, nonwoven, knit, braided, or any other fibrous network. While not shown in FIGS. 7A-7H as including a woven fabric membrane prior to placement within the receiving portion 3114 of the mold 3112, in other configurations, the woven fabric sheet 3116 may include a woven fabric membrane. In a further configuration, the woven fabric sheet 3116 may be pre-laminated (e.g., with polyurethane or silicone) with the woven fabric sheet 3116.

[0207] After the fabric sheet 3116 is positioned along the mold 3112, the fabric sheet 3116 may be pressed into place within the receiving portion 3114. In some configurations, rollers may be used to ensure the fabric sheet 3116 is positioned in the correct position as shown in Figures 7C and 7D. In other configurations, a vacuum seal may be used to pull the fabric sheet 3116 toward the receiving portion 3114. In still other configurations, other forms of pressing the fabric sheet 3116 into the receiving portion 3114 may be used.

[0208] After the fabric sheet 3116 is in place, a membrane material can be placed along the top surface of the fabric sheet 3116, as shown in FIG. 7E. The membrane layer 3118 can be a thermoplastic or thermosetting material, silicone, polyurethane, or other material. The material for the membrane layer 3118 can be sprayed, painted, or sprayed, as shown, or pre-laminated onto the fabric sheet 3116. The membrane layer 3118 can be a resin or other material that cures or hardens through a chemical process or exposure to air. As shown, the membrane layer 3118 is a liquid thermosetting material. The membrane layer 3118 is distributed along the top surface to cover the surface as needed by the manufacturer. In some configurations, the entire top surface of the fabric sheet 3116 need not be covered. That is, in some cases, leaving portions of the fabric sheet 3116 uncovered can facilitate measuring and securing the attachment weight to other components. Additionally, in other configurations, the fabric sheet 3116 can be a laminate and already include a surface formed by the membrane material.

[0209] Additionally, the membrane layer 3118 may be thicker in some areas than in other areas. Different thicknesses can be achieved by applying the membrane layer 3118 in liquid form at different rates. Additionally, the membrane layer 3118, when formed as a separate, solid layer, may be pre-fabricated to be thicker in some areas (e.g., the nasolabial fold engaging region 3107) than in other areas (e.g., the flange 3107).

[0210] 7F, the membrane layer 3118 and the textile sheet 3116 may be exposed to heat. The heat may melt the membrane layer 3118 (if the membrane material has solidified) or may allow the membrane layer 3118 to be dispersed or deposited consistently along the textile sheet 3116. In other forms, the membrane layer 3118 may be allowed to solidify after the step shown in FIG. 7E without requiring any additional heat to the system.

[0211] After the membrane layer 3118 has solidified, the fabric sheet 3116 is removed from the mold 3112 together with the cured membrane layer 3118, as shown in Figure 7G. The fabric sheet 3116 disposed within the receiving portion 3114 then assumes the shape of the receiving portion 3114, even after being removed from the receiving portion 3114. Because the membrane layer 3118 is a thermosetting material that can be cured into a specific shape, the sealing layer 3102 also assumes the same shape as the membrane layer 3118.

[0212] As shown in Figure 7H, the sealing layer 3102 is cut away from the remainder of the textile sheet 3116. As shown, the sealing layer 3102 is cut away with scissors or shears, although in other forms, the sealing layer 3102 can be cut using other techniques or devices, such as a die cut. In a non-limiting example, in some forms, a hot knife can be used to cut the sealing layer 3102. In other forms, a stamp can be used to cut the textile sheet 3116.

[0213] As shown (see FIGS. 6A-6C ), the first nostril opening 3108 and the second nostril opening 3110 can be formed in the sealing layer 3102. The first nostril opening 3108 and the second nostril opening 3110 can be formed in a receiving portion 3114. That is, the receiving portion 3114 can be formed using peaks or valleys to affect the topography of the receiving portion 3114. Varying the shape of the receiving portion 3114 can enable a variety of shapes for the sealing layer 3102. In some forms, the fabric sheet 3116 can be pre-cut along the areas of the receiving portion 3114 corresponding to the first nostril opening 3108 and the second nostril opening 3110. In other forms, after curing, the material of the sealing layer 3102 can be excised in the areas where the first nostril opening 3108 and the second nostril opening 3110 will be located. Additionally, other post-processing steps may be performed on the sealing layer 3102 after it is removed from the mold 3112 .

[0214] In some configurations, the woven fabric sheet 3116 can be pre-cut before being placed on the mold 3112. In such configurations, the number of folds in the sealing layer 3102 of the seal-forming structure 3100 can be reduced compared to other configurations. For example, as shown in FIG. 7I, the woven fabric sheet 3116 is separated from a pre-cut sheet 3117. The pre-cut sheet 3117 includes various notches 3120. These notches 3120 are specifically formed so that the material of the pre-cut sheet 3117 does not fold and overlap upon itself when the pre-cut sheet 3117 is placed in the mold 3112. That is, the pre-cut sheet 3117 may form an adjacent joint (as opposed to an overlapping joint), which may lead to improved user comfort and feel. As shown in FIG. 7I, for example, a notch 3122 is formed between a first flap 3124 and a second flap 3126 of the pre-cut sheet 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 .

[0215] 7J , after the sheet 3117 is placed in a mold and cured with the membrane, the first flap 3124 and the second flap 3126 can be folded over to conform to the mold shape. 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 varied to allow for a variety of designs and configurations. As shown in FIG. 7J , the first flap 3124 and the second flap 3126 do not overlap each other. However, in other configurations, the flaps may be designed to overlap each other to allow for increased stiffness in certain areas (e.g., the nasolabial fold engagement area 3107).

[0216] 7I and 7J allow for smooth inner and outer surfaces of the sealing layer 3102. Additionally, cutting the textile sheet before forming may allow for a reduction in the amount of time used to place the textile sheet into a mold compared to other configurations in which the textile sheet is folded to fit within a mold.

[0217] 5.3.3 Positioning and stabilizing structures The seal-forming structure 3000, 6000, 7000, 8000, 9000, 10000 of the patient interface 3100, 9100 of the present technology may be held in a sealed position in use by the positioning and stabilizing structure 3300, 7300, 8300, 9300. The positioning and stabilizing structure may also be referred to as or include "headgear" as it engages the patient's head to hold the patient interface in a sealed position.

[0218] In one form, the positioning and stabilizing structure provides at least enough retention force to overcome the effect of positive pressure in the plenum chamber 3200, 9200 to lift off the face.

[0219] In one form, the positioning and stabilizing structure provides a holding force sufficient to overcome the attractive force on the patient interface.

[0220] In one form, the positioning and stabilizing structure provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface (e.g., due to tube drag or inadvertent interference with the patient interface).

[0221] In one form of the present technology, there is provided a positioning and stabilizing structure configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure has a low-profile profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure includes at least one flat strap.

[0222] In one form of the present technology, a positioning and stabilizing structure is provided that is configured so that it does not have an excessively large or bulky size that would interfere with a patient sleeping in a supine sleep position with the posterior region of the patient's head resting on a pillow.

[0223] The positioning and stabilizing structure may include at least one tie. A tie may be understood as a structure designed to resist tension. In use, the tie is the portion of the positioning and stabilizing structure that is under tension. Some ties, as described above, add elasticity resulting from this tension. The tie may function to maintain the seal-forming structure in a therapeutically effective position on the patient's head. In certain forms of the present technology, the positioning and stabilizing structure may include ties in the form of headgear tubes and / or headgear straps, as described below.

[0224] In one form of the present technology, the positioning and stabilizing structure includes a first tie constructed and arranged such that, in use, at least a portion of its lower edge passes over and moves to the superior auricular point of the patient's head, covering a portion of the parietal bone without covering the occipital bone. The first tie may be provided as part of a patient interface including, for example, a cradle cushion, nasal pillows, nasal cushion, full-face cushion, or oral-nasal cushion. For example, the positioning and stabilizing structure may include the first tie in the form of a gas delivery tube provided above the patient's head. The gas delivery tube may also be known as a headgear tube, as it provides the function of headgear.

[0225] In one form of the present technology suitable for a nasal-only mask or a full-face mask, the positioning and stabilizing structure includes a second tie. The second tie is constructed and arranged so that, in use, at least a portion of its upper edge passes under the lower ear base of the patient's head and covers or rests under the occipital bone of the patient's head. The second tie may be provided as part of a patient interface including, for example, a cradle cushion, a nasal pillow, a full-face cushion, a nasal cushion, or an oral-nasal cushion. For example, the positioning and stabilizing structure may include a second tie in the form of a strap provided against the posterior surface of the patient's head.

[0226] In one form of the present technology suitable for a nasal-only mask or a full face mask or an oronasal mask, the positioning and stabilizing structure includes a third tie configured to be secured against the back of the patient's neck. Further, in some forms the positioning and stabilizing structure includes a fourth tie constructed and arranged to interconnect the second tie and the third tie in a manner that reduces the tendency of the second tie and the third tie to move apart.

[0227] In certain forms of the present technology, the positioning and stabilizing structure includes a bendable, e.g., non-rigid, strap. An advantage of this embodiment is that the strap is more comfortable when the patient lies down during sleep. The positioning and stabilizing structure may include a bendable strap. The strap may be considered a backstrap. The strap is sufficiently flexible to extend around the back of the patient's head and be comfortably positioned against the patient's head, even when under tension in use.

[0228] In certain forms of the present technology, the positioning and stabilizing structure includes straps configured to be breathable to allow water vapor to pass therethrough.

[0229] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure, each configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure that is suitable for large heads but not for small heads, and another form that is suitable for small heads but not for large heads.

[0230] In certain forms, the positioning and stabilizing structure may be referred to as "ducted headgear" because it may include a gas delivery tube for conveying pressurized breathable gas through the mask interface (e.g., cushion module) to the patient's airway.

[0231] 4B, for example, a patient interface is illustrated. As shown, the patient interface 3000 includes a gas delivery tube, shown as tube 3350. The tube 3350 runs around the patient's head along the parietal bone, extending from above the ear to the seal-forming structure 3100. The tube 3350 may deliver air to the seal-forming structure 3100 and may support the seal-forming structure 3100 in place. As such, it may be possible to use the tube 3350 both as a support structure and as an air conduit. For example, in other configurations, a separate tube (e.g., air delivery tube 3348) may be attached directly to the seal-forming structure 3100 and not extend around the patient's head. In such configurations, the tube is not supported by the patient's head and does not provide support to the sealing structure. Such configurations also include separate straps that support the sealing structure.

[0232] The patient interface 3000 includes a head strap 3420 attached to the tube 3350 of the patient interface 3000. The head strap 3420 can be used to support the tube 3350 and assist in accurate 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 backward on the patient's face during normal use. Furthermore, the head strap 3420 works in conjunction with the tube 3350 to provide sufficient upward force on the sealing structure 3100 to help maintain the sealing structure 3100 in the correct position against the patient's face, so that the sealing layer 3102 properly seals the air openings on the patient. Thus, the stabilizing structure 3300 can include at least the tube 3350 and the head strap 3420.

[0233] In some embodiments, the head strap 3420 may be directly and permanently attached to the tube 3350. That is, removing the head strap 3420 from the tube 3350 results in damage to either or both the head strap 3420 and the tube 3350. As shown in FIG. 5A , the head strap 3420 is attached directly to the tube 3350 between the inner and outer layers of the tube 3350. In some embodiments, no stitching is required in the head strap 3420. For example, in some embodiments, the head strap 3420 is sandwiched between the inner and outer layers of the tube 3350, and this area is exposed to heat. The inner and outer layers of the tube 3350 may include a thermoplastic or thermoset material that changes when heated. Therefore, when heated, this material may melt or soften, thereby interacting 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 configurations, the head straps 3420 may include removably attachable portions (e.g., hook-and-loop fasteners). In such configurations, the tubes 3350 may include slots through which the head straps 3420 can pass. The patient can then adjust the fit of the patient interface 3000 by moving the tabs on the head straps 3420 and securing the straps in place. In other configurations, an adjustable string or rope or leash can be used to allow the patient interface 3000 to fit comfortably on the patient's head.

[0234] As shown, the seal-forming structure 3100 extends to the patient's nose while providing an unobstructed position for the mouth. Some patients prefer a proprietary interface that includes a specific type of mask, such as those shown in Figures 4A-4D, to allow them to talk while receiving treatment. Other patients may prefer a full mask or a mask that encircles the mouth depending on need or comfort. Various forms of this technology can be used depending on the patient's particular method of use. While shown as a nasal mask, a full face mask may also be used.

[0235] In some forms, the sealing structure includes a base 3104, which allows the seal-forming structure 3100 to be removably attached to a frame 3152. The base 3104 may include a clip mechanism, allowing the seal-forming structure 3100 to be attached to the frame 3152 (see FIG. 4P). The frame 3152 may include attachment points or locations to which 3350 can be attached. Thus, air enters the frame 3152, then travels to the seal-forming structure 3100 and ultimately to the patient.

[0236] In other configurations, different frames may be used. For example, in some configurations, the frame may include various slots or attachment points, allowing the frame to interact with straps (e.g., straps from the head strap 3432). For example, although not shown in FIG. 4A, the frame may include a forehead support that includes slots that interact with the straps. Additionally, as shown in FIG. 5F, a lower slot adjacent the structure (e.g., the seal-forming structure 3100) may be used to allow for interaction with the head straps and an adjustable fit of the headgear or stabilizing structure 3300.

[0237] In one form of the present technology, the positioning and stabilizing structure 3300, 7300, 8300, 9300 comprises a decoupling portion located between the anterior portion of the positioning and stabilizing structure and the posterior portion of the positioning and stabilizing structure. The decoupling portion does not resist compression and can be, for example, a flexible or pliable strap. The decoupling portion is constructed and positioned such that when a patient lies with their head on a pillow, the presence of the decoupling portion prevents posterior forces from being transmitted along the positioning and stabilizing structure and disrupting the seal.

[0238] In one form of the present technology, a positioning and stabilizing structure includes a strap constructed from a laminate of a fabric patient inner layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0239] In certain forms of the present technology, the positioning and stabilizing structure includes a stretchable (e.g., elastically stretchable) strap. For example, the strap can be configured to be tensioned in use to direct a force that seals the seal-forming structure against a portion of the patient's face. In one example, the strap can be configured as a tie.

[0240] 5.3.3.1 Positioning and stabilizing structures according to embodiments of the present technology 5.3.3.1.1 Headgear tubing 4B, the patient interface 3000 includes at least one tube 3350 that delivers pressurized air received from a conduit (e.g., air delivery tube 3348) forming part of the air circuit 4170 from the RPT device to the patient's airways, for example through the plenum chamber 3200 and the seal-forming structure 3100. This tube 3350 is an integral part of the headgear 3300 of the patient interface 3000 such that the seal-forming structure 3100 of the patient interface is positioned and stabilized on an appropriate part of the patient's face (e.g., nose and / or mouth). As a result, the air delivery tube 3348 providing the pressurized air flow can be connected to the connection port 3600 of the patient interface in a position other than in front of the patient's face, which may be obscured by some.

[0241] The positioning and stabilizing structure 3300 may be described as airtight or air-retentive because it is capable of containing and moving air through the tube 3350 for delivery of pressurized air from the air circuit 4170 to the patient's airway. It is understood that an airtight or air-retentive positioning and stabilizing structure 3300 does not require all components of the positioning and stabilizing structure 3300 to be airtight.

[0242] In certain forms of the present technology, the patient interface 3000 may include a connection port 3600 that is located near the top, side, or back of the patient's head. For example, in the form of the present technology shown in FIG. 4B, the connection port 3600 is located on top of the patient's head when in use. Patient interfaces where the connection port is not located in front of the patient's face may be advantageous as some patients may find it unsightly and uncomfortable when a conduit is connected to a front-of-face patient interface. For example, a conduit connecting to a front-of-face patient interface may be prone to becoming tangled with bedding or bed linens, especially if the conduit extends downward from the patient interface when in use. Forms of the present technology that use patient interfaces with a connection port located near the top of the patient's head when in use may make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: a lateral or horizontal position, a supine position (i.e., lying face up), and a prone position (i.e., lying face down). Additionally, connecting the conduit to the front of the patient interface can lead to a problem known as tube drag, in which the conduit can create an undesirable pulling force on the patient interface, causing it to be pulled down and away from the face.

[0243] 4A, 4B-4D, at least one tube 3350 extends from the connection port 3600 over the patient's cheek region and over the patient's ear between the cushion assembly 3150 (i.e., between a portion of the tube 3350 that connects to the cushion assembly 3150 that covers the maxillary region of the patient's head in use and a portion of the tube 3350 that covers the region of the patient's head above the superior ear base point). Additionally, in some configurations, such as those shown in FIGS. 4A and 4B-4D, the tube 3350 is positioned along both sides of the user's face. That is, for example, the tube 3350 extends at the patient's right and left cheek regions.

[0244] In the form of the technology shown in FIG. 4B, the positioning and stabilizing structure 3300 includes a single tube 3350 including left and right sections. Each section is positioned on a different side of the patient's head in use and extends through each cheek area from above each ear (above the superior ear base point on the patient's head) to a connection port 3600 on the top of the patient's head. This form of technology can be advantageous because if the patient is lying on their side and one of the tubes is compressed, blocking or partially blocking gas flow along that tube, the other tube remains open and can provide pressurized gas to the patient. In other embodiments of the technology, the patient interface can include a different number of tubes (e.g., one tube or three or more tubes).

[0245] 4B, the patient interface has one tube 3350. The single tube 3350 is positioned on one side of the patient's head in use (e.g., over one cheek area) and the head strap 3420 forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head in use (e.g., over the other area) to help secure the patient interface 3000 on the patient's head. As shown, the tube 3350 extends continuously from one side of the cushion assembly 3150 to the connection port 3600 and back to the other side of the cushion assembly 3150.

[0246] 4B, the left arm 3302 and the right arm 3304 are continuously connected. That is, there is no specific connection point between the left arm 3302 and the right arm 3304. That is, a fluid connection extends seamlessly between the two arms. Forming the conduit 3350 continuously may allow the number of components of the patient interface 3000 to be reduced compared to other forms of the present technology.

[0247] 4A-4D , the tube 3350 curves around the top of the patient's head from the top end of the tube 3350 containing the connection port 3600 on the top of the head to the tab 3346 to the point where the rear headgear straps 3420 connect to the tube 3350 without any curvature in the coronal plane. Between the tab 3346 where the rear headgear straps 3420 connect to the tube 3350 and the bottom end of the tube 3350 where the tube 3350 connects to the cushion assembly 3150 in front of the patient's airway below the nose, the tube 3350 curves forward or anteriorly across the cheek area between the patient's ears and eyes. The radius of the curve in this portion of the tube 3350 can be in the range of 60-100 mm, for example, 70-90 mm (e.g., 80 mm). The lower end of the tube 3350 and the point where the rear headgear straps 3420 connect to the tube 3350 may be at an angle ranging from 65 to 90 degrees (eg, 75 to 80 degrees).

[0248] 4A-4D, the tube 3350 extends substantially vertically in a superior (i.e., upward) direction from near the superior ear base point to the connection port 3600. That is, the tube 3350 has an angle of 0 to 15 degrees relative to the coronal plane in the region between the superior ear base point and the connection port 3600. In other embodiments, this angle may be greater depending on the patient's positioning. Furthermore, when the tube 3350 is formed, such tube 3350 has a greater angle relative to the sagittal plane from the patient's superior ear base point to the airway.

[0249] 4B-4D , the tube 3350 includes a connection port 3600. The connection port 3600 may be partially disposed within the tube 3350. That is, a portion of the connection port 3600 extends through the outer layer 3354 and between the outer layer 3354 and the inner layer 3352 of the tube 3350. In this manner, the connection port 3600 is sandwiched between the tubes of the tube 3350. The connection port 3600 may be configured to connect to another tube (e.g., an air delivery tube 3348 of a treatment device that provides air flow from the air circuit 4170). In some forms, the air delivery tube 3348 may form all of the air circuit 4170, and in other forms, the air delivery tube 3348 forms only a portion of the air circuit 4170. The air delivery tube 3348 may be formed from a variety of materials (e.g., woven materials, silicone, and other materials). Integrating the connection port 3600 into the tube 3350 may reduce the number of seams or connection points along the tube 3350 as compared to other forms of the present technology. Additionally, integrating the connection port 3600 into the tube 3350 may allow for minimizing or eliminating the use of additional connection mechanisms (e.g., adhesives, fasteners, or other additional mechanism features). In other forms, the connection port 3600 includes an inner portion and an outer portion. The inner portion may be disposed between the inner layer 3352 and the outer layer 3354. When the outer portion interacts with the inner portion, the outer layer 3354 is sandwiched between the inner and outer portions of the connection port 3600.

[0250] In some embodiments, textiles are used to form various components of the stabilization structure 3300. As shown, the tube 3350 is formed from a textile material. Some patients find the silicone tube uncomfortable during use when the tube is placed against the patient's face. Additionally, some patients find the silicone tube uncomfortable even when a textile sleeve or sock is placed over the silicone tube. The thickness and weight of the silicone tube can cause patients to stop using the device. Furthermore, when the patient lays their head down, the silicone tube can fold or bend, making the thickness of the tube easily felt on the patient's face (even when covered with a textile sleeve). A textile conduit or tube, such as the tube 3350, can increase comfort for some patients.

[0251] A woven material may be a flat, planar sheet of material, or may be formed through a three-dimensional configuration to allow the woven material to have a positive or negative curvature. As used herein, the terms "woven material" or "fabric" may be used to describe any fiber network. For example, a woven material or fabric may be woven, nonwoven, knit, braided, or any other form of fiber network. Different configurations of woven materials may be used to tailor different properties. For example, a woven configuration may be used in the cross and longitudinal directions for specific strength, while a knit structure may be used for flexibility and stretch. Furthermore, in some configurations, woven materials may combine different configurations to achieve specific properties. Furthermore, the density of the material may be variable depending on various desired properties. For example, if greater stretch is desired, a lower density fiber network may be used.

[0252] Furthermore, the fabric may be made from a variety of materials. The fabric may be made from natural or rigid materials. To name a few, cotton, rayon, polyester, linen, silk, leather, polyurethane, monofilament or multifilament materials, or any combination of these materials, may be used in addition to other materials. Material selection may be based on feel, texture, stiffness, flexibility, extensibility, and other factors. Additionally, the fabric may include both natural and synthetic materials. Natural fibers or yarns (e.g., cotton) may be used to provide a soft feel and comfortable fit to the patient. Synthetic fibers may be used to add stiffness or strength to specific areas of the fabric and for other properties.

[0253] In some embodiments of the present technology, different materials may be used within the same woven material. Different materials may be used to provide specific properties to a woven component. For example, stretchable fibers, strands, or yarns may be oriented in a specific direction within the woven fabric to provide strength along the longitudinal or first direction. Secondary fibers that are substantially non-stretchable or stretch-resistant may be oriented within the woven fabric along the transverse or second direction. In this manner, the woven fabric may be anisotropic, having different properties in various directions to support a specific component. For example, a tube may be formed from the woven material. The woven material may be configured to expand or stretch when pressure is applied in a first direction. In a second direction different from the first direction, the woven material may be configured to resist stretch or deformation when pressure or force is applied. For example, a tube may be configured to expand radially when air pressure is applied to the woven material. Such stretchability may allow the tube to receive or accept air and may also allow the tube to be comfortably positioned facing the patient. However, the tube may have a particular longitudinal orientation along the patient's face, in which case longitudinal stretching of the tube is undesirable. Fixing or limiting longitudinal stretch may allow the tube to be maintained in a position that allows the patient to receive consistent treatment.

[0254] In some configurations, the woven tube may be formed from one or more sheets or layers of woven material. In some configurations, a single sheet may be folded or rolled and secured along its lateral edges to form the tube with a single seam. In other configurations, more than one sheet may be used. For example, the woven tube may be formed with a first side configured to contact the patient, which may be referred to as the inner layer. The woven conduit may also include a second side, which may be attached to the inner layer but positioned away from the patient, which may be referred to as the outer layer. The inner and outer layers may be secured to each other along their edges, respectively, thereby forming a flow path or passageway between the seams of the inner and outer layers. That is, the space between the seams is left unattached.

[0255] As described in this detailed description, the inner and outer layers each include 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 is disposed away from the inner layer, and the outer surface of the inner layer is disposed away from the outer layer. Furthermore, in embodiments including a single sheet, the inner surface is the surface of the sheet that is disposed inward or toward itself.

[0256] In some embodiments, the sheet or tube sheet may include an air-impermeable layer or woven membrane. In some embodiments, the inner surface of both layers includes a membrane configured to restrict or inhibit air from passing through the layer from the inner surface to the outer surface. The impermeable layer may be a thin layer less than the thickness of the woven sheet of the inner or outer layer. In other embodiments, the impermeable layer may exceed the thickness of the woven sheet of either layer. The impermeable layer or woven membrane or film may be completely impermeable to air movement or may be configured to allow a predetermined rate or air movement and a specific pressure. In further embodiments, the membrane may be specifically designed to allow a specific amount or quantity of air, water vapor, or moisture to pass through the fabric, thereby making the tube 3350 breathable and allowing water vapor to escape and / or be transmitted through the tube 3350. Removing air through the membrane may allow air to escape through a component (e.g., the tubing conduit or the sealing structure itself), eliminating the need for a separate bleed-off valve for exhaust air. Additionally, in some forms, a region may be adjusted within a particular region. For example, a region may be varied within the tube 3350 along the cheek region. This region may become warm during use and may be uncomfortable for the user. Varying the region allows a constant flow of air through the tube 3350 to the patient's skin, providing a cooling effect. The type of membrane and region of the membrane may be variable or adjustable depending on the nature of the fabric in which the membrane is placed and the mode of use.

[0257] In some embodiments, the thickness of the woven membrane may be variable. In some embodiments of the present technology, the woven membrane may be less than 5% of the thickness of the woven fabric. In other embodiments, the thickness of the woven membrane may be 5% to 25% of the thickness of the woven fabric. In further embodiments, the thickness of the woven membrane may be 25% to 50% of the thickness of the woven fabric. Furthermore, the thickness of the woven membrane may be 50% to 100% or more of the thickness of the woven fabric. Varying the thickness of the woven membrane affects the stiffness and stretchability of the woven fabric. For example, a woven fabric comprising a woven membrane that is 1% of the thickness of the woven fabric may have lower stiffness and higher stretchability compared to a woven fabric comprising a woven membrane that is greater than 50% of the thickness of the woven fabric. In some embodiments, a thicker woven membrane may be used to provide additional strength in certain areas of the conduit or sealing interface. That is, the thickness of the woven membrane may be increased in high-stress areas or areas more likely to kink or crease during use.

[0258] The membrane may be formed from a thermoplastic or thermoset material such that when exposed to a particular temperature, the membrane material can be molded or formed into a particular shape and then hardened or set or solidified upon cooling. In some forms, the membrane may be formed from silicone or polyurethane.

[0259] Additionally, in some forms, the membrane material may assist in bonding the seams of the layers together. For example, when a thermosetting or thermoplastic material is exposed to certain heat, the material may crosslink, such as a thermosetting material, or melt, such as a thermoplastic material. After solidification, the materials can be bonded together. For example, applying heat along the edges of the outer layer 3354 and the inner layer 3352 to the membrane along the inner surface 3356 of the outer layer 3354 and the membrane along the inner surface 3358 of the inner layer 3352 can form a seam between the two layers.

[0260] The inner layer can be attached to the opposing outer layer along first and second seams. After the layers are attached to one another, a tube or conduit can be formed between the two layers. By securing the layers along their edges, a central chamber is formed that allows for air flow or other gaseous or liquid medium when secured together with the air circuit 4170.

[0261] The tube 3350, as shown in FIG. 4B, is formed using a woven fabric including a membrane. The tube 3350 includes an inner layer 3352 and an opposing outer layer 3354. Both the inner layer 3352 and the outer layer 3354 include an impermeable membrane along their inner surfaces. While described and illustrated as including only the inner surface coated with an impermeable layer, in some configurations, both the inner and outer surfaces of the layers of the tube 3350 may include an impermeable membrane. However, in some configurations, the impermeable membrane may be oriented away from the patient's face. Orienting the tube 3350 in this manner allows the impermeable membrane layer to be spaced from the patient while still allowing the soft feel of the fabric to press against the patient. This allows for the formation of a single piece of material with different properties depending on the side of the material used. This can reduce manufacturing costs and the time required or necessary to form the component.

[0262] 5.3.3.1.1.1 Tube shape and composition Referring to FIG. 4F, a cross section of a tube 3350 is illustrated. In some embodiments, the inner layer 3352 and the outer layer 3354 may be formed from multiple layers of woven and / or membrane materials. By varying the thickness and composition of the layers of the tube 3350, different properties can be achieved. As shown in FIG. 4F, and particularly as shown in FIG. 4F-1, the inner layer 3352 includes a woven fabric sheet 3360 in conjunction with a woven membrane 3362. The woven fabric sheet 3360 may be formed from felt, spacer fabric, foam material, woven, knit, or nonwoven material, or other fiber network. As shown, the woven fabric sheet 3360 is a felt-type fabric. In this manner, the outer surface 3374 of the inner layer 3352 may have a soft feel against the patient's face. The outer layer 3354 is comprised of multiple sheets of woven fabric. The outer layer 3354 includes a tube sheet 3364 and an outer covering 3366. In some configurations, both sides of the tube sheet 3364 can be covered with a woven fabric film. As shown in FIG. 4F-2, the tube sheet 3364 includes a woven fabric film 3368 exposed to the chamber of the tube 3350 and a woven fabric film 3370 along the opposite side of the tube sheet 3364. The woven fabric film 3368 can assist in providing a seal between the inner layer 3352 and the outer layer 3354 and forming an airtight tube. The woven fabric film 3370 can assist in bonding the tube sheet 3364 to the outer covering 3366. In other configurations, the tube sheet 3364 can be glued or bonded directly to the outer covering 3366. In other configurations, the outer layer 3354 includes a heat-formable, shape-retaining material or materials (e.g., a foam layer disposed between the tube sheet 3364 and the outer covering 3366). In other configurations, the tube sheet 3364 can be heat-formed. As will be discussed in more detail later in this detailed description, a shape-retaining material may be used to provide the tube 3350 with a predetermined shape.

[0263] The configuration, orientation, and composition of the inner and outer layer 3352, 3354 sheets can help provide support to the tube 3350 to avoid blockage during use. As shown in FIG. 4F , the cross section of the tube 3350 is substantially D-shaped, such that an air passageway 3372 is formed between the inner and outer layers 3352, 3354. Because the inner layer 3352 is substantially planar, the inner layer 3352 has zero curvature. Because the outer layer 3354 curves away from the inner layer 3352, the inner surface 3356 of the outer layer 3354 has a positive curvature between the joints. As shown, the curvature of the inner surface 3356 varies between the joints of the tube 3350. That is, the curvature can be negative adjacent to where the inner and outer layers 3352, 3354 are joined together. However, it should be recognized that the overall curvature taken from the center point between the joined edges of the tube 3350 is positive. In other words, the outer layer 3354 has a non-planar configuration that forms an arcuate cross-section between its joined edges. That is, the inner surface 3356 of the outer layer 3354 may have a concave shape, and the outer surface 3376 of the outer layer may have a convex shape. By fixing the curvature of the outer layer 3354, when the outer layer 3354 is not subjected to a force, for example, due to the weight of an external force or air pressure, the inner surface 3356 of the outer layer 3354 has a substantially positive curvature. Thus, in contrast to some conventional conduit sections that have identical or symmetrical shapes, the inner layer 3352 and the outer layer 3354 are asymmetric.

[0264] Additionally, the inner surfaces of the inner layer 3352 and the outer layer 3354 may have a D-shaped cross-section. That is, the inner surfaces may enclose a D-shaped air passageway 3372. Thus, in some forms, the inner surfaces of the inner layer 3352 and the outer layer 3354 may form a D-shaped cross-section and the outer surfaces of the inner layer 3352 and the outer layer 3354 may also form a D-shaped cross-section.

[0265] In this manner, the outer layer 3354 can be curved away from the inner layer 3352. As shown in FIG. 4F , the outer layer 3354 and the inner layer 3352 are attached to one another along their longitudinal edges, so that the edges of the inner layer 3352 and the outer layer 3354 are flush with one another. Bonding zones or joints between these attachment points causes the outer layer 3354 to be curved away from the inner layer 3352. That is, between the joints 3312 (see FIG. 4H ), the inner surface 3356 of the outer layer 3354 is positioned away from the inner surface 3358 of the inner layer 3352. In some forms, the outer layer 3354 is pre-formed so that, in an unpressurized or supported state, the outer layer 3354 is pre-positioned and pre-formed such that it extends away from the inner layer 3352 between opposing joints 3312. That is, the outer layer 3354 can support its own weight so that it remains spaced apart from the inner layer 3352 between the joints 3312 even when not supported by pressurized air or other support mechanism.

[0266] The generally D-shaped cross section may vary along its length (e.g., a tall, thin D-shaped cross section near the patient's nose and a wide, shallow D-shaped cross section near the top of the patient's head along the cheeks). For example, FIGS. 4I-4K show various cross sections of the tube 3350 along its length according to one form of the tube 3350. As shown, the D-shaped 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 tube length (e.g., a relatively long width and a short height at the manifold end compared to a relatively short width and a tall height at the interfacing structure end). In some forms, the D-shaped cross section of the tube 3350 may be asymmetric along the entire length of the tube or at least along a portion(s) of the tube. Additionally, the cross sections all have a very similar or common hydraulic diameter (e.g., about 10-15 mm or about 13 mm). Additionally, width and height may refer to the chamber size rather than the overall size of the cross section including the exterior seam area.

[0267] Additionally, the tube 3350 may provide flatter areas in certain areas (e.g., where the patient rests on the tube during sleep). In this manner, the tube can be said to be 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 low profile, comfort, and / or stability. However, the tube 3350 may have other suitable cross-sectional shapes (e.g., trapezoidal, semicircular, cylindrical, elliptical, oval, flatter cross-section). These tubes may also have flat configurations with anti-collision ribs. This arrangement is disclosed in U.S. Patent Application No. 10 / 385,701, which is incorporated herein by reference in its entirety.

[0268] Furthermore, as shown in Figures 4L-1 to 4L-4, because tube 3350 is soft, tube 3350 can be easily deformed under finger pressure. That is, tube 3350 cannot be formed with a rigid structure that cannot be deformed. That is, tube 3350 is formed such that tube 3350 can deform when subjected to finger pressure. However, tube 3350 can also maintain its shape when not subjected to air pressure or other forces.

[0269] Additionally, the outer layer 3354 may be a resilient structure. The outer layer 3354 may deform when subjected to pressure or force during normal use, thereby accommodating patient movement during sleep and use. For example, the tube 3350 may be buckleable, such that the outer layer 3354 presses against the inner layer 3352, not only at the sealed edges but also between the sealed edges. However, once the force from the outer layer 3354 is removed, the outer layer 3354 may return to a predetermined shape, including a positively curvature inner surface. That is, the outer layer 3354 is capable of supporting its own weight (e.g., without changing shape through bending or twisting), and therefore is not a flexible structure. The Shore hardness of the outer layer 3354 may be between 0010 and 0030. In other embodiments, the outer layer 3354 may be stiffer and therefore configured to withstand greater forces.

[0270] The outer layer 3354 can include a material that resists plastic deformation. For example, the outer layer 3354 can be bent or folded so that a portion of the outer surface 3376 can abut the outer layer 3354 when subjected to a force. However, when the force is released, the outer layer 3354 returns to the shape it had before the force was applied. Instead of plastically deforming or collapsing, the outer layer 3354 elastically deforms and returns to the predetermined shape. Furthermore, the majority of the tube 3350 can be similarly bent, folded, or twisted. That is, the material forming the tube 3350 can be a material that does not plastically deform when folded.

[0271] In contrast, the inner layer 3352 can be a flexible component. When the inner layer 3352 is attached and secured to the edge of the outer layer 3354, the inner layer 3352 becomes 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 become planar due to forces applied to the inner layer 3352 through the seam of the tube 3350. Because the outer layer 3354 resists deformation, it can maintain the contraction of the inner layer 3352, thereby causing the inner layer 3352 to become planar. In another form, the inner layer 3352 can be cut so that it is wider than the outer layer 3354 but is connected to the outer layer 3354 along the edge of the tube 3350. In such a configuration, the unsecured portions of the inner layer 3352 may be able to move inward toward the outer layer 3354 .

[0272] In some embodiments, the inner layer 3352 may be flexible in some areas and rigid in other areas. For example, in some embodiments, stiffeners may be used in the arm support 3314 to impart stiffness to the inner layer 3352, making it less flexible in certain areas. However, in some embodiments, the inner layer 3352 may remain flexible between seals on the tube 3350. That is, no additional stiffeners are used between seals or joints on the tube 3350. The Shore hardness of the stiffeners may be A30 to A90 or greater.

[0273] In other forms, the inner layer 3352 may be at least semi-elastic, i.e., while the inner layer 3352 may not be able to support its own weight, the support of the outer layer 3354 may allow the inner layer 3352 to support some of its own weight, such that the inner layer 3352 remains positioned in substantially the same position (when not subjected to an additional force (e.g., air pressure or other external force)).

[0274] The inner layer 3352 is relatively flat, as shown, and is adapted to rest 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, allowing for a comfortable fit for a wide range of patients. The inner layer 3352 has a relatively large surface area, which allows for more even load distribution. This configuration reduces the occurrence of pressure points during use. The inner layer 3352 may also have a gripping material, which can assist in stabilizing the patient interface on the patient's face.

[0275] In some embodiments, the outer layer 3354 may be more elastic than the inner layer 3352. That is, the outer layer 3354 may be more resistant to deformation than the inner layer 3352. Furthermore, the outer layer 3354 may return to a predetermined shape more easily than the inner layer 3352. Furthermore, in some embodiments, the outer layer 3354 may be harder or stiffer than the inner layer 3352. As shown in FIGS. 4F-4F-2, the outer layer 3354 may include more layers than the inner layer 3352, and the outer layer 3354 may be thicker than the inner layer 3352. Configuring the outer layer 3354 and the inner layer 3352 in this manner may help make the outer layer 3354 relatively harder or stiffer. This increased stiffness, rigidity, and / or elasticity may help maintain an open passageway through which air can pass. Additionally, in some forms, the outer layer 3354 may comprise a harder material than the inner layer 3352. Such a material composition may help provide a harder or stiffer outer layer 3354.

[0276] The outer layer 3354 has a smooth contour that conforms to the patient's face. That is, the outer layer 3354 has a contour or organic form (e.g., tangentially) with edges that conform to the patient's face, thereby eliminating any edges that may pinch into bedding, pillows, etc. during sleep (e.g., when the patient is lying down). As shown, the tube 3350 has a non-cylindrical cross-sectional shape, which provides a contour that conforms to the patient's face (see FIGS. 4A-4D). Such a conforming contour is smooth, streamlined, and smooth, allowing the tube 3350 to conform or taper to the contour of or the interior of the patient's head (e.g., anatomically consistent, unobtrusive, and aesthetically pleasing). Additionally, the conforming contour does not have sharp edges that may cause discomfort (e.g., skin irritation or chafing).

[0277] In some configurations, thermoforming of the outer layer 3354 can be performed such that the material in the outer layer 3354 assumes the shape of the mold or mandrel. Upon hardening or cooling, the thermoformed material assumes the shape shown in FIG. 4F . In some configurations, an additional layer can be disposed between the outer covering 3366 and the tube sheet 3364. In some configurations, this additional material can be a foam material or other thermosetting material. In other configurations, the tube sheet 3364, the outer covering 3366, or both can be formed from a foam material or a thermosetting material. In still other configurations, a thermoplastic material can be used. In still other configurations, any other shape-retaining material can be used. As shown, the cross-sectional shape of the tube 3350 can be maintained without additional stiffening or components beyond the outer layer 3354 and the inner layer 3352 sheets. Furthermore, the thickness of the inner layer 3352 can be substantially the same along its width. Furthermore, the outer layer 3354 can also be substantially the same thickness along its width. Once thermoformed, the outer layer 3354 may be able to maintain a predetermined shape without assistance from the inner layer 3352. That is, the outer layer 3354 may maintain a predetermined shape without tension, force, or support from the inner layer 3352.

[0278] 4R, the patient interface 6000 may include a vent formed in the conduit 3350 (e.g., in the outer layer 3354) so ​​that exhaust gases are released to the atmosphere. In the illustrated example, the vent 6100 is formed adjacent the cushion assembly 3150. Additionally, the air delivery conduit 6348 may have a woven construction. For example, the air delivery conduit 6348 may have a construction similar or identical to any of the conduit embodiments disclosed herein.

[0279] 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 having connectors at their upper and lower ends so that they are individually releasably connectable to both the cushion assembly 3150 and the hub 7200. For example, at the upper and lower ends of the left arm 7302 and the right arm 7304, respectively, an upper connector 7312 and a lower connector 7314 are provided, as shown in FIGS. 4T and 4U. The upper connector 7312 is configured to releasably connect to the hub, and the lower connector 7314 is configured to releasably connect to the cushion assembly 3150.

[0280] 4T and 4U, in these examples, the upper connector 7312 and the lower connector 7314 can each include a connector body 7303, a slot 7309, a chamfered edge 7308, and a notch 7306 that can be removably connected to clips in the cushion assembly 3150 and the hub 7200 via a snap fit. In another example, the connectors 7312 and 7314 can be provided in the cushion assembly 3150 and / or the hub 7200, and receivers can be provided on the left arm 7302 and the right arm 7304.

[0281] As shown in FIG. 4S, elbow 7220 may be pivotally connected to hub 7200 and includes a swivel connector on the opposite end for connection to an air delivery supply tube.

[0282] Returning to FIG. 4V, a cross section of the tube 7350 is illustrated. Similar to the outer layer 3354, the outer layer 7354 can be constructed to support its own weight. As shown, the outer layer 7354 includes an outer covering 7402 that forms the outer surface of the outer layer that is positioned away from the patient's face during use. An outer cushioning layer 7406 (e.g., a foam material) is disposed between the outer covering 7402 and a fabric member 7410 that forms the air impermeable surface of the air passageway. The outer cushioning layer 7406 can be heat formed to retain its shape. Adhesive layers 7404 and 7408 can be disposed between the outer covering 7402 and the outer cushioning layer 7406 and between the outer cushioning layer 7406 and the fabric membrane 7410, respectively. In another embodiment shown in FIG. 4W, the outer cushioning layer 7406 and adhesive layer 7408 can be removed.

[0283] 4V , the inner layer 7352 includes a fabric sheet 7222 configured to engage the patient's face during use. An inner cushioning layer 7426 (e.g., a foam material) is disposed between the fabric sheet 7222 and the fabric member 7230 to form an air impermeable surface for the air passageway. Adhesive layers 7224 and 7228 may be disposed between the fabric sheet 7222 and the inner cushioning layer 7226 and between the inner cushioning layer 7226 and the fabric member 7230, respectively.

[0284] 4X, the patient interface 8000 includes a positioning and stabilizing structure 8300 having 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 may have different stiffnesses. For example, the lower portion 8362 may be stiffer than the upper portion 8364, or vice versa. This may be achieved, for example, by constructing 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 by constructing the outer layer 3354 of the lower portion 8362 to have a different stiffness than the outer layer 3354 of the upper portion 8364. It should be noted that the left and right arms may each have three portions with different properties (e.g., stiffness) rather than just a lower and upper portion.

[0285] In the illustrated embodiment, the inner and outer layers 3352, 3354 of the lower portion 8362 are stiffer than the inner and outer layers 3352, 3354, respectively, of the upper portion 8364. As such, the upper portion 8364 is more flexible and can better conform to the curvature along the side of the patient's face up to the top of the patient's head. Providing a tab 3346 on the lower portion 8362 may allow for improved connection to the strap 3420, as the increased stiffness of the lower portion helps to resist twisting and maintain the desired application of vector force. Alternatively, the tab 3346 may be provided on the upper portion 8364 or may straddle the upper and lower portions 8364, 8362.

[0286] In some embodiments, the cross-sectional shape of the conduit may be specifically formed. For example, in some embodiments, the conduit may be pre-formed with a flat or planar contact surface and a convex outer layer. The shape of the conduit may be specifically formed to provide a specific feel and to regulate the amount or quantity of oxygen or air forced through the conduit 3350 to the patient. That is, the conduit may be formed to limit the amount the conduit stretches or expands (when exposed to an air or oxygen source). Additionally, the cross-sectional shape of the conduit 3350 may vary along its length. For example, the cross-sectional shape of the conduit 3350 may be different adjacent the connection port 3600 compared to the adjacent cushion assembly 3150. The cross-sectional shape and volume encompassed by a specific shape may vary depending on the configuration of the patient interface 3000 and the patient's interaction with it. For example, the end of the left arm 3302 may have a smaller cross-section than the point where the left arm 3302 connects with the connection port 3600. Because the end of the left arm 3302 is more likely to be associated with sensitive areas of the patient's face, limiting the cross-sectional size of the end of the left arm 3302 may increase patient comfort compared to other forms of the technology.

[0287] Additionally, varying the width of the inner or outer layer may allow for alteration or variation in the size of the chamber. For example, the portion of the inner layer 3352 forming part of the air passageway 3372 may have a width W1 at a first location on the left arm 3302, as shown in FIGS. 4C and 4G. When joined together, the inner layer 3352 and the outer layer 3354 form a cavity or chamber associated with the air passageway 3372 with a cross-sectional area and volume V1. As shown in FIG. 4H, 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 may be greater than the width W1. Furthermore, as shown, the cavity formed within the region of W2 has a volume V2 that is greater than the volume V1. Thus, as breathable air passes through the region of width W2, the cross-sectional area of ​​the tube 3350 at the location having width W2 is greater than the cross-sectional area of ​​the tube 3350 at the location having width W1. Furthermore, at the location having the second width W2, the volume of the chamber may be greater than the volume at the first width.

[0288] The width can be varied to provide different properties or functions. In some embodiments, varying the volume of air or oxygen within a particular point can be used to vary the flow rate through various portions of the woven conduit. For example, if the woven conduit has a large cross-sectional area at a first location, breathable air delivered through the woven conduit can flow at a first velocity. If the woven conduit also has a smaller cross-sectional area at a second location, breathable air delivered through the woven conduit at the second location can flow at a second velocity that is greater than the first velocity. Thus, the conduit volume size can be varied to increase or decrease the velocity of air passing through the conduit.

[0289] In some embodiments, the chamber size of a woven conduit can be altered by changing the shape of the woven layers and / or by changing the width of a joint or joint in a woven tube or conduit. A "junction" refers to the area of ​​one layer of tubing that is joined to another layer of tubing, or, in some embodiments, where a layer is attached to itself if the tubing is formed by a single layer. For example, as shown in FIG. 4G, junction 3312 is where a layer, such as inner layer 3352, is joined to lower layer 3354. Varying the width of junction 3312 alters the size of the chamber formed in the woven conduit. For example, a wider junction reduces the chamber volume compared to a narrower junction. The width of the junction can be different on either side of the woven conduit. Furthermore, the width of the junction can also vary along the length of the woven conduit.

[0290] Varying the width of the joint 3312 can allow for the stiffness of the woven conduit to be varied along its length. For example, in locations that are subject to higher stress or greater potential for bending, the width of the joint can be greater than in areas without similar potential for bending. The width of the joint 3312 can depend on the width of the welding or cutting mechanism used to form the tube 3350. In other configurations, separate heating mechanisms may be used to bond the layers together. In such situations, the heating mechanism can be moved around to create wider or narrower joints 3312. While not shown along the exterior of the tube 3350, in some configurations, the tube 3350 can be flipped inside out so that the joint is located within the chamber of the tube 3350.

[0291] In some forms, the position of the joints 3312 around the D-shaped cross section of the tube 3350 can be varied to adjust the flexibility and stiffness of the tube along its length.

[0292] In some embodiments, the joints may be formed using a variety of techniques to impart specific properties to the joint. For example, in some embodiments, the joints may be formed using ultrasonic welding, radio frequency welding, and cutting and welding techniques. The application of heat to specific areas activates thermosetting or thermoplastic materials used in the tube 3350. This heat may be used to not only bond the layers together, but also to thermoform layers such as the outer layer 3354. Additionally, in some embodiments, bonding such as stitching or adhesives may be used to bond the layers together. In some embodiments, stitching is not used. In further embodiments, no material beyond the material disposed within the layer is used to bond the inner and outer layers of the tube 3350. For example, in some embodiments, the inner and outer layers may be formed such that no additional material, such as adhesives or stitching, is required to bond the inner and outer layers.

[0293] In some embodiments, the tube 3350 can be covered with a sleeve (eg, made of fabric) to mimic the look of bedding.

[0294] 5.3.3.1.1.2 Patient interface shape The tube 3350 may also have a variety of curvatures along its length that correspond to the shape of the patient's face. As noted above, the cross section of the tube 3350 may have a particular shape. The shape of the tube 3350 may vary along its length (not just its width as shown in FIG. 4F ). 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. This curvature may be provided within the tube 3350 to correspond to the generally negative curvature of the patient's face along the region where the tube 3350 contacts the patient's head. However, because the curvature of a patient's face is complex and variable, it should be noted that at the point where the tube 3350 contacts the patient's head, the head is generally negatively curved. Furthermore, this curvature may be achieved even when the user is not wearing the headgear 3300. That is, the curvature of the length of the tube 3350 may correspond to a predetermined non-planar configuration.

[0295] 4L-1 through 4L-4, the tube 3350 is illustrated in isolation. As shown, the tube 3350 is bent or shaped along three dimensions such that the inner layer 3352 and the outer layer 3354 are disposed about various planes. For example, the outermost portion 3378 of the outer layer 3354 adjacent the connection port 3600 extends along the XY plane. In contrast, the outermost portion 3380 of the outer layer 3354 of the right arm 3304 is disposed along the YZ plane. Additionally, in some embodiments, the tube 3350 may include additional bends such that when the right arm 3304 is rotated along the Z axis, a portion of the outermost portion 3380 extends along the XZ plane. In this manner, the tube 3350 may have a predetermined shape in three dimensions.

[0296] Specific views of a portion of the tube 3350 are shown in Figures 4L-2 to 4L-4. In particular, Figure 4L-2 is a side view of a portion of the tube 3350. Figure 4L-3 is a front view of a portion of the tube 3350. Figure 4L-4 is a top view of a portion of the tube 3350.

[0297] Based on the geometry of the tube 3350, the tube 3350 may be made stiffer in certain regions. As shown in FIG. 4L-1 , different levels of force may be required to bend or twist the tube 3350 about various axes. That is, the tube 3350 may withstand deformation or bending along a plane or axis (to a greater degree in a first region than in a second region). For example, bending or twisting the tube 3350 along the XY plane may require a different level of force in a first region 3308 adjacent the connection port 3600 than in a second region 3310 of the right arm 3304. By orienting the tube 3350 in a particular direction, the strength of the cross-sectional shape of the tube 3350 may be used to withstand bending in a particular direction, helping to provide a safe patient interface 3000.

[0298] Additionally, the tube 3350 as shown in FIG. 4L-1 can be bent or oriented to different degrees. For example, the left arm 3302 and the right arm 3304 can be positioned closer to each other than shown. That is, the spacing along X between the left arm 3302 and the right arm 3304 can be smaller. The spacing between these arms can be varied during manufacture of the tube 3350 depending on the particular desired shape. Additionally, in some forms, the shape of the tube 3350 can be configured to align or conform to the patient's face. The tube 3350 can have a shape that is complementary to the shape of the patient. 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 with an opposite positive curvature such that the inner layer 3352 is positioned flush with the user's face. Additionally, other areas of the patient's face have a positive curvature. The outer surface 3374 of the inner layer 3352 can be configured with an opposing negative curvature so that the inner layer 3352 is positioned against the user's face. The tube 3350 can be formed with an inward bend in the arms so that the tube 3350 provides compression against the user's face. That is, in some forms, the left arm 3302 and the right arm 3304 can be oriented at an angle relative to a plane. The left arm 3302 can be positioned in a plane that, when extended, intersects the plane in which the right arm 3304 is positioned. This orientation can provide compression to the user's head, aiding in comfort and snugness.

[0299] In some forms, the left arm 3302 and the right arm 3304 may have bellows that increase the flexibility of the left and right arms, allowing the arms to bend and conform to the patient's face.

[0300] In some embodiments, the shape of the tube can be specifically formed. The top view shape of the conduit can be varied. In contrast to silicone tubing, the shape of the woven tubing can be cut and formed to produce a specific shape (rather than being molded entirely by a molding process such as injection molding). This ability to determine a specific shape without complex molds can allow for reduced manufacturing costs compared to other embodiments.

[0301] In some embodiments, the layers may be woven in a specific manner so that the layers are woven into a specific shape. In other embodiments, a woven, nonwoven, or other fiber netting may be cut into a specific shape. In some embodiments, an L-shaped conduit may be formed. In other embodiments, a U-shaped tube 3350 may be formed, as shown in FIG. 4E, for example. By forming the air delivery system from a woven material, a variety of other shapes and configurations may be formed. Additionally, handling a flat or planar sheet may aid in manufacturing and assembly. The ability to handle the material in two-dimensional space reduces the complexity of joints, connections, or bends. While not shown in two dimensions for clarity in FIG. 4E, in other embodiments, such as those shown in FIGS. 4A-4D, the tube 3350 may be bent or twisted during manufacturing to allow the tube 3350 to assume a predetermined three-dimensional shape.

[0302] In some embodiments, multiple layers can be combined to form a single tube. In contrast to other embodiments, forming a tube from multiple separate sheets can facilitate complex designs and specific shapes. For example, instead of forming a tube in a three-dimensional shape, the shape can simply be cut out of two-dimensional layers. The layers can then be further processed to form the three-dimensional shape. Initially forming or planning the shape formation in two dimensions can make processing easier, less time-consuming, and more cost-effective than other embodiments.

[0303] The patient interface 3000 can be configured not only to maintain its shape without pressure or force, but also to spring up to assume a predetermined shape. The patient interface 3000 can be placed in packaging before the patient opens and uses the patient interface 3000. Today, some patient interfaces are difficult to orient when worn on the patient's head. The straps of some interfaces can become entangled, making the exact manner in which the patient interface is worn unclear. However, the patient interface 3000 is configured so that the patient interface 3000 springs up to assume a predetermined shape when removed from packaging, luggage, or any confined space. That is, the patient interface 3000 orients the arms of the patient interface 3000 (without requiring any additional effort on the part of the user), making the manner in which the patient interface 3000 is worn clear to the patient (without the need to further unravel or position components of the patient interface 3000). This configuration can facilitate patient use of the patient interface 3000.

[0304] 5.3.3.1.1.3 Structural support In some forms, the joint can be used as a seal for the tube 3350 and as a stiffening or support structure for the tube 3350. The arm support 3314 is a wider joint that can be used to precisely direct the force vector and provide a seal between the seal-forming structure 3100 and the patient's airway. The arm support 3314 can resist bending and therefore can provide sufficient force both rearward and upward through the tube 3350 to the cushion assembly 3150 to provide a seal between the seal-forming structure 3100 and the patient's airway. Referring to FIGS. 4A-4D , the 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 provided along a portion of the right arm 3304. The arm support 3314 resists bending of the left arm 3302 so that when the patient wears the patient interface 3000, the patient seal-forming structure 3100 maintains proper positioning relative to the user's face or nose. For example, when worn, the headgear 3300 may tend to form a straight line between the patient's upper ear base and the patient's airway. That is, as the conduit 3350 bends into the cushion assembly 3150, the headgear 3300 tends to straighten. The arm support 3314 resists rotation of the left arm 3302 about X. As shown, the arm support 3314 is formed by an inner layer 3352 and an outer layer 3354. That is, since no additional materials or components are required for the arm support 3314, the arm support 3314 is formed only by the materials and layers used to form the conduit 3350. In this manner, the stabilizing structure 3300 may be formed in an efficient manner without the need for additional components. Additionally, separate stiffening beyond the inner layer 3352 and outer layer 3354 may be provided at various locations on the tube 3350 (e.g., within the arm support 3314 or along the outer surface of the arm support 3314). In other forms of the present technology, separate stiffening is used to stiffen the tube 3350. The stiffening element in one form of the present technology is preferably thin-walled and conforms to a patient's position thereon, yet is stiff enough to withstand out-of-plane bending.That is, the stiffening element is constructed to allow bending in some planes and resist bending in other planes (e.g., toward and away from the patient's face). The stiffening element also renders the tube 3350 non-stretchable in areas where the tube 3350 is in tension to maintain size by utilizing the stiffening element or not stretching. The stiffening element may be located within the air flow path of the tube 3350 or may be located external to the tube 3350.

[0305] Additionally, a stiffener may correspond to a component that has a higher hardness and / or stiffness than the surrounding material. Furthermore, a stiffener may be used to resist finger deformation. Furthermore, a stiffener may refer to a component other than the layers forming the inner layer 3352 and the outer layer 3354. For example, a particular region of the tube 3350 may include additional components beyond the materials used to form the inner layer 3352 and the outer layer 3354. In some forms, the connection port 3600 (see FIGS. 4M and 4N) may be considered a stiffener. The connection port 3600 may be formed from a material that is harder than the surrounding material, such that the connection 3600 can resist finger deformation. In other forms, a stiffener may refer to a material other than the inner layer 3352 or the outer layer 3354 that is permanently attached to the inner layer 3352 or the outer layer 3354. Furthermore, a stiffener may increase the stiffness of the layer in contact with the stiffener (compared to a layer without the stiffener).

[0306] In one form, the stiffening element may provide structural strength or a self-retaining form to the patient interface, allowing it to retain its shape without bulking (e.g., shape memory) whether or not the patient interface is attached to a patient's head. Such a shape-retaining arrangement may maintain the tube in a desired position and assist in donning the patient interface during use.

[0307] In some configurations, stiffening elements may be used in specific locations. For example, stiffening elements may be used between layers of the stabilizing structure 3300. For example, stiffening elements may be disposed between the inner layer 3352 and the outer layer 3354. In other configurations, stiffening elements may be disposed between the various sheets forming the inner layer 3352 and the outer layer 3354. In other configurations, stiffening elements may be disposed along the inner or outer surface of the stabilizing structure 3300. In further configurations, stiffening elements may be disposed in areas of high stress, such as when the head straps 3420 interact with the tube 3350. The use of stiffening elements may provide stiffening to the overall shape of the patient interface 3000 and support for the cross section of the tube 3350, thereby resisting buckling of the tube 3350.

[0308] In some forms, the stiffening element may be positioned along the outer surface of the headgear 3300. For example, the stiffening element may be positioned at the arm support 3314 along the outer surface 3376 of the outer layer 3354. In some forms, no stiffening material is provided within the chamber of the tube 3350 between the connection port 3600 and the assembly connection ports 3154 and 3155. In other forms, no stiffening material is provided between the connection port 3600 and the assembly connection ports 3154 and 3155 at the junction of the inner layer 3352 and the outer layer 3354. In further forms, no stiffening material contacts the inner layer 3352 between the connection port 3600 and the assembly connection ports 3154 and 3155.

[0309] In other forms, the structure and orientation of the inner layer 3352 may allow bending in some directions while providing sufficient stiffness to resist bending in other directions. That is, the inner layer 3352 may be constructed to allow bending in some planes and resist bending in other planes (e.g., to allow bending toward and away from the patient's face to conform to the patient's head and resist bending along the plane in which the inner layer 3352 extends). Thus, in a first plane, the inner layer 3352 is configured to bend, and in a second plane, the inner layer 3352 resists bending. The first plane may be perpendicular to the second plane. Like the inner layer 3352, the outer layer 3354 may also be capable of allowing and resisting bending.

[0310] As described above, the joints 3312 can form a rigidified mass. The joints 3312 can be configured to allow the tube 3350 to bend in some planes and resist bending in other planes (e.g., to allow bending in a first plane proximal and distal to the patient's face to conform to the patient's head, and to resist bending along a second plane through which the inner layer 3352 extends). Additionally, the joints 3312 can be configured to be substantially rigid to resist bending in the first and / or second planes.

[0311] In other embodiments, the size of the conduit may contribute to its bend resistance. For example, in some embodiments, the conduit may have a smaller cross-section than the first region. The first region (e.g., a region having width W1) may have a higher material density relative to the volume or space that the first region may contain. Increasing the material density at a given location may allow for increased strength, stiffness, or resistance to bending or deformation perpendicular to the outer layer 3354 in that particular region (relative to other regions). Particular regions that may be exposed to increased forces, such as bending or twisting, may be specifically configured with a particular material that resists bending or twisting. For example, as shown, the tube 3350 is narrower at the end point 3306. The end point 3306 may be connected to the cushion assembly 3150. The mask region may be more prone to bending and kinking. Therefore, altering the material density at the mask connection location may reduce the likelihood of kinking and bending within the tube 3350.

[0312] 5.3.3.1.1.4 Pipe layer characteristics In some embodiments, the inner layer 3352 and the outer layer 3354 are formed from different materials. In some embodiments, the inner layer 3352 can be formed from a softer woven 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 specifically contoured to the patient's skin to provide comfort. The outer layer 3354 can be a different material than the inner layer. The outer layer 3354 is more likely to catch on abrasives or be scraped against objects. Therefore, in some embodiments, the outer layer 3354 is formed from a less soft and durable material than the inner layer. Furthermore, the outer surface 3376 of the outer layer 3354 and the outer surface 3374 of the inner layer 3352 can have different surface properties than the inner surfaces of each layer. Furthermore, the outer surface 3374 can have a higher coefficient of friction than the outer surface 3376 of the outer layer 3354, thereby maintaining the position of the patient's facial positioning and stabilizing structures.

[0313] In some embodiments, certain surfaces may be laminated with a membrane. For example, in some embodiments, a membrane is provided only on the inside of a conduit or sealing structure. Thus, the outer and inner surfaces may have different properties. The outer surface may be made of cotton, which may be softer and more breathable. This surface may be more pleasant or comfortable for the patient than a silicone or polyurethane surface. However, the inner surface may be laminated or coated with a membrane. As such, the membrane surface may be spaced or isolated from the patient. Having different material properties on the inner and outer surfaces of a woven conduit may allow for improved comfort of certain components.

[0314] Additionally, the outer surface 3376 may include only a textile surface. That is, the outer surface 3376 may not be coated or laminated with a textile film. In some configurations, the outer surface of a particular sheet may or may not be laminated with a textile film, depending on the particular tube design. For example, to provide a comfortable surface for the patient, the outer surface 3374 of the inner layer 3352 may not be coated or aligned with a textile film. However, the outer surface 3376 of the outer layer 3354 may include a film for protection or improved resistance to abrasion or other external forces. Furthermore, because the outer layer 3354 is spaced from the patient's skin, it may not be necessary to form the outer layer 3354 with different surface properties along the inner and outer surfaces 3356 and 3376. For example, the outer layer 3354 may be dipped in a thermoplastic or thermosetting material and coated on both sides with a textile film. In such a configuration, the time required to soak the outer layer 3354 may be shorter than the time required to laminate a single surface layer, which may allow for reduced manufacturing costs for the outer layer 3354.

[0315] The overall weight of the positioning and stabilizing structure is preferably less than 50 g (eg, less than 40 g or less than 30 g). The thickness of the inner layer 3352 and outer layer 3354 may each be less than 2 mm (less than 1 mm).

[0316] The use of woven sheets may facilitate color customization. For example, one sheet may be blue and the other white. Different colors may allow consumers to select specific combinations, which may increase the likelihood that patients will adhere to treatment with the device.

[0317] Forming the headgear, tube, or conduit in this manner may allow the headgear to be specifically formed to adjust or conform to the contours of a patient's face. Unlike a straight cylindrical tube, the manner in which the inner and outer layers are cut and attached to one another may allow the shape of the woven conduit to be determined.

[0318] 5.3.3.1.1.5 Patient Interface in Use The patient interface 3000, as shown in Figures 4B-4D, may be worn on the patient's head. Once in position, pressurized air is supplied through the air delivery conduit 3348. From the air delivery conduit 3348, the pressurized air is routed through the left arm 3302 or the right arm 3304 or both arms. The air is then routed into the cushion assembly 3150 through the assembly connection ports or ports 3154 and 3155. In this manner, air is delivered to the patient.

[0319] In some forms, the cross-section of the tube 3350 may be modified or changed as pressurized air is delivered through the tube 3350. As shown in FIGS. 4F, 4G, and 4H, the inner layer 3352 is substantially planar. In some forms, during use, the inner layer 3352 may expand or flex, moving away from the outer layer 3354 between the joints 3312. That is, the inner surface 3358 of the inner layer 3352 may have a positive curvature. In other words, the outer surface 3374 of the inner layer 3352 has a negative curvature between the joints 3312. This curvature may help space other portions of the inner layer 3352 away from the patient's face or head. For example, this curvature may space the joints away from the patient's face, increasing patient comfort.

[0320] In some forms, the outer layer 3354 may also expand when exposed to pressurized air during use of the patient interface 3000. While the outer layer 3354 is formed with a predetermined shape, the outer layer 3354 is not a rigid structure and may expand when exposed to pressurized air. This expansion may occur in the material itself (e.g., the outer layer 3354 is stretched), or may occur by moving the edges of the tube 3350 proximally toward each other. For example, as the joints 3312 move toward each other, the curvature of the inner surface 3356 of the outer layer 3354 becomes more positive than in the unpressurized state. This shape change can be tailored to suit a particular comfort level and patient feel during use.

[0321] Additionally, as noted above, a region of the tube 3350 may be adjusted in a particular area. In one area, the tube 3350 may be completely impermeable to air, while in another area, a certain amount of air may be allowed to move through the tube 3350. For example, in some forms, a region of the tube 3350 may be adjusted to allow a certain amount of air to move from the tube 3350 to the patient's cheek. Additionally, the tube 3350 may be adjusted so that air only moves through one layer of the tube 3350 (i.e., toward the patient through the inner layer 3352 or away from the patient through the outer layer 3354).

[0322] The woven structure of the tube 3350 allows the positioning and stabilizing structure to be less resonant than conventional air delivery tubes and conduits, thereby reducing confusion for the patient and thereby promoting compliance with treatment.

[0323] 5.3.3.1.1.6 Headgear positioning In certain forms of the present technology, the stabilizing structure 3300 includes a mechanism for connecting headgear straps to the seal-forming structure 3100. The headgear straps may be connected directly or indirectly to the seal-forming structure 3100. As shown in FIG. 4C , tabs 3346 configured to connect to, for example, head straps 3420, protrude outwardly from the tube 3350 in a generally rearward direction. These tabs 3346 have holes or slots therein for receiving the ends of the head straps 3420. However, as shown, the straps 3420 may be secured between the inner layer 3352 and the outer layer 3354. That is, the straps 3420 may be secured without any additional material beyond the material of the inner layer 3352 and the outer layer 3354. For example, the straps 3420 may be secured using the thermoset or thermoplastic material of the inner layer 3352 and the outer layer 3354. Additionally, the strap 3420 may extend within the chamber of the tube 3350 or may be disposed external to the tube 3350. In other forms, the strap 3420 may take the form of a wire or string or other tubular structure that extends through an opening in the tab 3346.

[0324] In some forms of the present technology, the rear straps 3420 are adjustable. In some forms, the straps 3420 may include hook-and-loop fasteners, allowing a portion of the rear strap 3420 to be routed through a hole in the tab 3346 and secured onto itself. In some forms of the present technology, the angle of the straps 3420 relative to the tube 3350 or the patient's head can be adjusted to fit around the patient's head in different positions. This adjustability helps the headgear 3300 accommodate different head shapes and sizes.

[0325] In certain forms of the present technology, the strap 3420 applies a force to the tube 3350 at the location of the tab 3346 to pull the tube 3350 at least partially in a posterior (e.g., rearward) direction. The strap 3420 may also apply a force to the tube to pull the tube 3350 at least partially in an inward (e.g., rearward) direction. The magnitude of this force can be adjusted by changing the length of the strap 3420 between the tabs 3346.

[0326] 4C , the direction of force applied from the strap 3420 to the tube 3350 may be changed. This direction may be changed by adjusting the angle of the strap 3420 relative to the tube 3350 or the patient's head. In some forms of the present technology, the location at which force is applied from the strap 3420 to the tube 3350 can be changed by adjusting the location at which the strap 3420 is secured to the tube 3350.

[0327] In some forms of the present technology, when worn by a patient, the seal-forming structure 3100 tends to fall away from the patient, forward, and downward or downward. The headgear 3300 is positioned to counteract or neutralize these tendencies. The use of the tube 3350 in conjunction with the straps 3420 provides both an upward force and a backward force, thereby keeping the seal-forming structure 3100 in place during use. Additionally, the use of the tube 3350 in conjunction with the straps 3420 provides additional backward and upward force, thereby providing a seal from the sealing layer 3102 to the patient's airway. The downward force that the headgear 3300 receives from the seal-forming structure 3100 is at least partially neutralized by the arm support 3314. Additionally, the top of the tube 3350 keeps the headgear 3300 in place along the up / down direction, and the straps 3420 help maintain the position of the headgear 3300 in the fore / aft direction.

[0328] The direction and magnitude of force required for a secure fit and effective seal may vary between patients based on the position of the stabilizing structure 3300 on the head, which may vary due to differences in head shape and size, for example. In some forms of the present technology, the straps 3420 are adjustable, allowing for a balance of force for a range of head shapes and sizes to hold the headgear 3300 in a comfortable position while maintaining an effective fit.

[0329] 5.3.3.1.1.7 Connection Port Configuration The tube 3350 includes a number of connection components configured to move air in and out of the tube 3350. These connection components are integrated within the tube 3350 to provide a seamless or smooth transition and connection to other components of the treatment device. These connection components may be formed from a different material than the tube 3350. In some forms, the connection components are a hard or rigid plastic that can withstand bending or compression. Using such a material may reduce the likelihood of restricting air passing through the connection components.

[0330] 4M and 4N, a connection port 3600 is illustrated. As shown, the connection port 3600 includes an upper surface 3602 and an opposite lower surface 3604. A flow path 3606 extends between the upper surface 3602 and the lower surface 3604 to direct air from an intake 3608 to either side of a tube 3350. Air is directed into the intake 3608 and through the intake 3608 from the upper surface 3602 into the flow path 3606. The air is then directed along the tube 3350 to the patient's mouth and / or nose.

[0331] 4M, the connection port 3600 is illustrated within a portion of the tube 3350. In some forms, the connection port 3600 may be unsealed and connected to the layer of tube 3350. That is, the connection port 3600 may be able to slide along the inner surface of the layer of tube 3350. Instead of being sealed or mechanically connected to the layer of tube 3350, the connection port 3600 may be limited in its lateral movement by the shape of the tube 3350. For example, the width of the tube 3350 may be tapered or reduced so that the connection port 3600 cannot slide to a large degree.

[0332] 4O, a connection port of another form of the present technology is illustrated. 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 disposed 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 disposed around an opening in the tube 3350 and is aligned with the inner portion 3704. The outer portion 3702 may snap into or otherwise secure to the inner portion 3704. In this manner, the outer layer 3354 is secured between the inner portion 3704 and the outer portion 3702 of the connection port 3701. Additionally, the inner portion 3704 can include a support to prevent the inner layer 3352 from abutting the outer layer 3354 at the connection port. As shown, the inner section 3704 includes a support portion 3706. The support portion 3706 is a cage-type structure that provides a gap or space between the inner layer 3352 and the outer layer 3354 of the tube 3350 while allowing air to flow through the opening in the connection portion 3700 to the remainder of the tube 3350.

[0333] An additional connection component may connect the tube 3350 to the seal-forming structure 3100. As shown, two connection components attached to the tube 3350 connect to either side of the frame 3152 of the seal-forming structure 3100. The assembly connection port 3154 may be formed in a manner similar to the connection port 3600. Furthermore, the assembly connection port 3154 is configured to engage an opening in the seal-forming structure 3100 such that the cushion assembly 3150 is fluidly connected to the tube 3350. By utilizing more than one connection component, air can still be delivered to the patient if one side of the tube buckles due to, for example, the weight of the patient's head when the patient is sleeping on their side.

[0334] 5.3.3.1.1.8 How to make headgear tubes The air delivery system (e.g., tube 3350) of the stabilizing structure 3300 can be formed and manufactured using a variety of techniques. In some forms, the fabric layers or sheets used to form the tube 3350 can each be pre-formed to have a specific cross-section. These layers or sheets can be coated with a silicone, polyurethane, thermoplastic, thermoset, or other conformal material. This material can be the same material used to form the fabric membrane, as described above. In some forms, this layer can also function as the fabric membrane. After receiving the conformal material, the sheets or layers can be placed in a mold. These layers or sheets can then be heated to melt the conformal material. Heat is then removed from the layers, causing the conformal material to harden. The layers are then removed from the mold, allowing the layers to conform to the mold.

[0335] Referring now to Figures 8A-8F, an overview of one process used to form a tube or air delivery system is illustrated. As shown, a mold 3800 is formed with a substantially concave shape. The shape of the mold 3800 can be changed or modified depending on the shape of the tube to be manufactured. The woven fabric sheet 3360 can be a woven fabric sheet formed from the materials described above. In some configurations, the woven fabric sheet 3360 can already include a woven fabric membrane layer along the surface of the woven fabric sheet 3360. However, in the configuration shown in Figures 8A-8F, the woven fabric sheet 3360 does not already include a woven fabric membrane. The woven fabric sheet 3360 is then placed into the mold as shown in Figure 8B. After the woven fabric sheet 3360 is properly oriented, another sheet is placed on top of the woven fabric sheet 3360. As shown in Figures 8C and 8D, a woven fabric membrane 3362 is oriented opposite the woven fabric sheet 3360. The textile membrane 3362 may be a membrane formed from silicone, thermoplastic, or other materials as described above for textile membranes. In the step shown in FIG. 8D , the combination of textile sheet 3360 and textile membrane 3362 is heated to melt or partially melt the membrane and / or otherwise adhere it to the surface of textile sheet 3360. The combination of textile sheet 3360 and textile membrane 3362 may then be removed from mold 3800 after textile membrane 3362 has cured. After textile membrane 3362 has cured, textile membrane 3362 may take the shape of mold 3800, thereby allowing textile sheet 3360 to take the shape of mold 3800, thereby forming the inner layer 3352 described above. Note that either or both of inner layer 3352 and outer layer 3354 may be thermoformed to a predetermined shape. In other examples, neither inner layer 3352 nor outer layer 3354 is thermoformed.

[0336] In some configurations, multiple formed sheet and membrane combinations can be used to form a tube or section of an air delivery system. As shown in FIGS. 8E and 8F, both an inner layer 3352 and an outer layer 3354 can be thermoformed and combined to form the tube 3350. The tube 3350 can have a steady-state shape that includes a specific capacity for receiving pressurized air. Additionally, the tube 3350 is collapsible and easily crushable for storage. Because the tube 3350 includes the woven membrane 3362, the tube 3350 can return to the shape shown in FIG. 8F even after being folded or stored. Additionally, additional or different layers can be used to form a more or less rigid structure. For example, the outer layer 3354 can be formed to include a thermosetting material, such as a foam layer, that takes the shape of the mold 3800 when heated. Additional layers (e.g., fabric sheets, foam layers, fabric membranes, or other layers) can be used to provide sufficient shape retaining features or to provide tube 3350 with sufficient stiffness or rigidity to allow tube 3350 to maintain its shape.

[0337] In another configuration, a mandrel can be used. As a substitute for a negative mold such as mold 3800, the mandrel can be coated with various layers, such as inner layer 3352. After being coated with the desired layers, the mandrel can be heated, or the layers can be heated to activate the thermoplastic or thermoset material. The mandrel is then removed, and the inner layer 3352 or other layers are formed to the shape of the particular mandrel shape.

[0338] In another embodiment of the present technology, the film or conformal layer may be a liquid or paste. In a further embodiment, the conformal layer may not require heat to cure. For example, the conformal layer may cure by exposure to air, similar to an adhesive. In a further embodiment, a chemical reaction such as an epoxy or fiberglass resin may be used. In some cases, the molding process may limit the shape and design of a particular component. Therefore, in some embodiments, a deposition method for forming a variety of components may be used. The deposition includes a mold of a specific shape. A layer, such as a fabric or textile layer, may be placed into the mold. A resin, film material, or other material is then placed on the layer. The resin or other conformal material is then cured, causing the shape of the layer to correspond to the shape of the mold. In some embodiments, a release agent may be placed between the fabric layer and the mold to aid in easy removal of the layer from the mold. After being removed from the mold, the layer may maintain or retain the shape of the mold.

[0339] As shown in Figures 8G-8K, a tube 3363 can be formed using the techniques described above. As shown in Figure 8G, a woven fabric sheet 3360 is placed into a mold 3800. In Figure 8H, a woven fabric membrane 3362 is placed along the woven fabric sheet 3360. In this configuration, the woven fabric membrane 3362 can be applied in liquid form, as opposed to the method shown in Figure 8C. As shown in Figure 8I, the woven fabric membrane 3362 is spread along the woven fabric sheet 3360 so that the appropriate portions of the woven fabric sheet 3360 are covered by the woven fabric membrane 3362. After the woven fabric membrane 3362 is cured by heat or other means, the inner layer 3352, including the woven fabric sheet 3360 and the cured woven fabric membrane 3362, is removed from the mold 3800. The inner layer 3352 can be combined with the outer layer 3354 to form the tube 3350, as shown in Figures 8A-8F, in a manner similar to that described for the tube 3350.

[0340] After the two layers (e.g., the inner layer 3352 and the outer layer 3354) are formed, they may be joined along their longitudinal edges to form the chamber. In some embodiments, the two layers may be joined using an adhesive or other bond. In other embodiments, the layers may be joined using mechanical fasteners (e.g., nails, screws, or buttons). In other embodiments, the two layers may be sewn or stitched together. In a further embodiment, the two layers may be welded together. For welding, the two layers may be welded using high frequency or radio frequency welding. In a further embodiment, a hot knife may be used to cut the layers, and as the cutting occurs, portions of the two layers may melt and harden, thereby forming a seal between the two layers, thereby forming a seal between the first and second layers.

[0341] In some embodiments, welded connections can be used at various locations on the woven conduit. In some embodiments, welded connections can be used to connect other components to the woven conduit or to other components of the woven conduit. Instead of relying on physical fasteners (e.g., screws, clips, snaps), various types of welds can be used to secure components together. The use of welds can reduce bulky connections. Furthermore, the use of welded connection techniques can eliminate the need for additional connection components. For example, a connection between a woven conduit and an adapter or connector can be formed by placing a portion of a layer of the woven conduit around an adapter with the layer of the layer facing the adapter. The layer and adapter combination can then be heated to melt or form-conform the membrane to the adapter. Once the membrane hardens, a secure connection can be formed between the layer and the adapter.

[0342] With reference to FIGS. 8L and 8M, the techniques described above can be applied to more complex D-shapes. In addition to utilizing a mold and thermoplastic or thermosetting material solely to form the internal cross-section, the mold and thermoplastic material can also be used to form three-dimensional shapes across the length of the component. That is, in addition to forming chambers, the mold can be used to bend or rotate the tube 3350 along three axes so that it can maintain this shape without additional support. As shown in FIG. 8L, the mold 3802 includes a groove or recess 3804 extending in a first direction D1 and a perpendicular direction D2. The fabric sheet 3360 can be cut to a specific shape and then placed along the recess 3804 of the mold 3802. For simplicity, the fabric sheet 3360 can already be laminated with a thermosetting or other conformal film. As shown in FIG. 8M, the fabric sheet 3360 is heated to melt or conform the film to the shape of the recess 3804. After curing, when the fabric sheet 3360 is removed from the mold 3802 , the fabric sheet 3360 retains the shape of the receiving portion 3804 .

[0343] The tube 3350 can be formed using a sheet cast into a mold 3802 (see FIGS. 4L-1-4L-4). For example, in a similar manner as shown in FIGS. 8A-8F, a second sheet similar to the woven sheet 3360 can be formed and joined to the woven sheet 3360. As shown in FIGS. 4L-1-4L-4, the tube 3350 can be oriented in a variety of directions. That is, the tube 3350 can be formed or conformed back into a three-dimensional object. Forming the tube 3350 as a three-dimensional object can reduce the amount or number of folds or bends in the tube 3350 during use. For example, instead of requiring the patient to bend or twist the tube 3350 to conform to the patient's face, the tube 3350 can be pre-formed with the bends or kinks. Providing bends or twists in the shape of the tube 3350, as opposed to forming it in a later, separate step, may allow for the reduction of kinks that may reduce airflow through the tube 3350. As shown in Figures 4A-4D, the shape of the tube 3350 may be shaped to accommodate the shape of the patient's face and head as the tube 3350 is used by the patient. Forming the tube 3350 into a particular shape during the manufacturing process may reduce pressure points.

[0344] Additionally, in some forms, only a first sheet (e.g., woven fabric sheet 3360) is molded or formed in a mold, such as mold 3802. A non-preformed sheet may be attached to the molded sheet such that the second sheet conforms to the shape of woven fabric sheet 3360.

[0345] The woven membrane can be placed along various surfaces of the woven fabric. When the woven fabric is immersed in the material, all sides can be coated with or laminated with the membrane. Other forms of woven fabric can coat or laminate a single surface of the woven fabric. In some forms, the membrane or curing material can be placed along only a single surface of the fabric layer. That is, in some forms, the first surface of the textile material can be coated with another material, such as a thermosetting material, and the second surface can be uncoated textile. That is, different properties can be provided on either side of the material. The membrane can also be formed from various materials. In some forms, the woven membrane is formed from silicone, and in other forms, the membrane is formed from polyurethane. In other forms, different materials can also be used.

[0346] In some embodiments, the woven membrane can be placed along a flat or planar sheet of fabric. That is, a sheet of fabric can be manufactured and include a layer of membrane material along the surface of the fabric. In some embodiments, the membrane can be laminated onto the fabric in a sheet form. In other embodiments, the membrane can be dispersed around the fabric in a liquid or semi-liquid form, thereby coating the surface of the membrane or a portion of the surface of the membrane. The membrane can then be cooled or dried, causing it to harden along the surface of the fabric.

[0347] In some embodiments, various methods and techniques can be used to form various components of the treatment device. In some embodiments, flat or planar materials can be manipulated to form three-dimensional structures used in the treatment device. These materials can be custom-formed or tailored to allow for greater comfort compared to other embodiments. In some embodiments, the seal-forming structure can be formed from a woven material, which can be less obtrusive, 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, tubing can be formed from planar materials. Additionally, other components that contain or contact pressurized air can also be formed from planar materials. In addition to components that contain or direct pressurized air, other components, such as straps, can be formed from planar materials manipulated to form three-dimensional structures.

[0348] Known patient interfaces also often include separate headgear and air delivery components used to position and deliver breathable gas to a mask or the like. Known headgear typically includes an assembly of elastic (or inelastic) straps, buckles, locks, and / or clips. Known air delivery components typically include spiral reinforcement tubing with a diameter of 15-22 mm and a swivel connector. These known arrangements of headgear and air delivery components can be difficult to use for individuals with limited dexterity and / or inexperience. Additionally, these known arrangements of headgear and air delivery components can be uncomfortable or impractical to wear.

[0349] 5.3.3.1.1.8.1 Cut and Seal Method The formation and connection of components can be accomplished using a variety of methods and techniques. In one embodiment, multiple components can be formed using a cut-and-seal method. In this method, each component can be cut to a specific shape. In some embodiments, the cut components can then be stacked together. In other embodiments, multiple layers can be stacked together and then cut all at once. In some embodiments, the layers can be connected to each other during the cutting process. For example, in some embodiments, a hot knife can be used to cut and melt the layers together. In such a method, the time required to manufacture a particular component can be reduced compared to other manufacturing methods.

[0350] The sheets used to form the woven conduits can be less than 750 mm to 350 mm. In other configurations, the sheets can be greater than or less than 750 mm to 350 mm. Smaller sheet sizes may allow multiple woven conduits or pipes to be formed in a small location. Reducing the footprint of the elements used to form the woven conduits may allow for reduced manufacturing costs due to less space needing to be rented or maintained.

[0351] 9A-9E, an embodiment of the present technique for forming a tube through the use of a cut-and-seal method is illustrated. An outer covering 3366, a tube sheet 3364, and a fabric sheet 3360 are shown. As shown, each of these sheets includes a fabric membrane or other meltable membrane as described above. As described above, the outer covering 3366 can be used 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 can be formed of a material whose outer surface is soft against the user's skin, and also includes a fabric membrane configured to reduce the amount of air passing through the fabric sheet 3360. In some embodiments, the outer surface 3374 of the fabric sheet 3360 can be configured to be placed against the patient's skin.

[0352] As shown in Figures 9A and 9B, these layers are stacked on top of each other. In some forms of the present technology, guides may be placed on the layers to indicate the desired cutting locations. In some forms, the woven sheet 3360 may be pre-stretched prior to assembly. For example, the woven sheet 3360 may be stretched horizontally, vertically, or both horizontally and vertically to assume a particular configuration. After joining the upper and lower layers, tension is released from the woven sheet 3360, allowing it to assume an unstretched position. As a result, the upper layer may bend due to the woven sheet 3360 being in an unstretched state. Therefore, a particular shape can be achieved during manufacturing by pre-stretching the lower layer and then releasing the tension.

[0353] In FIG. 9B , a laser 3382 is used to both cut and seal various sheets of material. In some configurations, welding techniques such as high frequency (HF) or radio frequency (RF) welding may be used to form the seal. Additionally, in other configurations, a hot knife may be used. When the material is cut, a thermosetting, thermoplastic, or conformal film adjacent to the cut line may melt or change properties. Melting of the film allows for interaction between the film and adjacent layers. For example, a film on the outer covering 3366 may interact with the upper surface of the tube sheet 3364. Similarly, a film on the tube sheet 3364 may interact with the lower surface of the outer covering 3366. Furthermore, a film on the tube sheet 3364 may interact with the inner surface of the fabric sheet 3360. In other configurations, the tube sheet 3364 may include a film only along its lower surface, and the outer covering 3366 may include a film that melts and interacts with the upper surface of the tube sheet 3364. After the film melts, it may harden. Upon curing, the sheets are connected to one another along the cut lines. In this manner, a tube, such as tube 3450 (see FIG. 9C), is formed. In contrast to tube 3350, tube 3450 may not have thermoformed inner and outer layers. That is, outer layer 3354 and inner layer 3352 may be connected along their outer edges along a joint and, because they are not subjected to further heating, maintain a particular cross-sectional shape in the absence of internal air pressure or other forces.

[0354] In some embodiments, additional components may be used in the woven conduit during its formation. For example, in some embodiments, connection components may be used in the woven conduit during the manufacturing process. In some embodiments, an elbow or tubing connection may be placed along the inner layer, followed by fastening the outer layer to the inner layer. After placing the tubing connection along the inner layer, the outer layer is coated onto the inner layer. A connection is then formed between the inner and outer layers. As described above, this connection may be formed by various welding techniques. In some embodiments, the tubing connection may also be secured by the connection between the inner and outer layers. However, in other embodiments, the tubing connection may be confined within a chamber of the conduit or may be physically secured to the inner or outer layer. That is, in some embodiments, the tubing connection may be restricted in movement due to friction or space limitations within the chamber. In other embodiments, the tubing connection may be clipped into place, for example, as described above.

[0355] As shown, connection port 3600 is disposed between tube sheet 3364 and fabric sheet 3360. Additionally, assembly connection ports 3154 and 3155 may be similarly disposed. Connection port 3600 and assembly connection ports 3154 and 3155 are sandwiched between tube sheet 3364 and fabric sheet 3360. Once sealed as shown in FIG. 9B, the connection ports may be disposed within tube 3450 (without requiring a separate step of inserting or disposing a connection within the tube).

[0356] 9C-9E, the tube 3450 is illustrated in various states. As shown in FIG. 9D, the tube 3450 is illustrated in a steady state, with no internal air pressure. In this configuration, as shown in cross section, the outer layer 3354 and the inner layer 3352 extend substantially planarly along each other's surfaces. That is, in contrast to the previously described configurations of the present technology, the tube 3450 is not preformed to have a specific cross section. As such, the tube 3450 occupies less space when not in use compared to other configurations of the technology. Furthermore, the tube 3450 can be easily stored, making it a convenient, portable tube.

[0357] As shown in FIG. 9E, after receiving internal pressure (e.g., air pressure from a treatment device), tube 3450 may expand and / or open. Air may be delivered through connection port 3600, filling the internal chamber of tube 3450. The air may then be delivered to the end of tube 3450 and another connection mechanism (e.g., assembly connection ports 3154 and 3155) or to the patient's nose or mouth. With particular reference to the cross-sectional view of FIG. 9E, as shown, both tube sheet 3364 and outer covering 3366 are positioned along the top of the cross-section. Fabric sheet 3360 is positioned along the bottom of the cross-section. Because connection port 3600 and assembly connection ports 3154 and 3155 are positioned between tube sheet 3364 and fabric sheet 3360, airflow from the treatment device is directed to connection port 3600 and assembly connection ports 3154 and 3155, and therefore does not extend between tube sheet 3364 and outer covering 3366. In other configurations, the sheets may be designed to allow air to pass through either layer. Additionally, connection port 3600 and assembly connection ports 3154 and 3155 may be located in a variety of locations depending on the particular situation or design requirements.

[0358] In some embodiments, the inner layer 3352 and / or the outer layer 3354 may be formed of a non-extensible material. That is, in some embodiments, the inner layer 3352 and the outer layer 3354 may not stretch when subjected to internal air pressure, but may be able to expand, for example, as shown in FIG. 9E. In other embodiments, the inner layer 3352 and / or the outer layer 3354 may be formed of an elastic material that stretches when subjected to internal pressure. In further embodiments, the inner layer 3352 may include a non-extensible fabric, while the outer layer 3354 includes a extensible fabric. For example, the stretch or extensibility of the inner layer 3352 and the outer layer 3354 may be different.

[0359] Once formed in the configuration described above, the outer layer 3354 can be cut or slit so that the outer layer 3354 extends around the inlet 3608 of the connection port 3600. Similarly, the inner layer 3352 can be cut or slit so that the inner layer 3352 extends around the assembly connection ports 3154 and 3155. The cutting or slicing of the outer layer 3354 can be performed before or after the outer layer 3354 is secured to the inner layer 3352. Then, in some configurations, the outer layer 3354 is heated in a specific location, causing the membrane to melt and the outer layer 3354 to conform to the inlet 3608 of the connection port 3600. When the membrane associated with the tube sheet 3364 hardens, a secure connection is formed between the outer layer 3354 and the connection port 3600. Similar arrangements can be used for the inner layer 3352 and the assembly connection ports 3154 and 3155.

[0360] In another aspect, the outer layer 3354 and the inner layer 3352 are flexible, stretchable, and elastic such that the outer layer 3354 and / or the inner layer 3352 can stretch around the inlet 3608 of the connection port 3600 or the similar inlets of the assembly connection ports 3154 and 3155. The outer layer 3354 includes a membrane that contacts the connection port 3600, which can assist in providing a proper seal between the outer layer 3354 and the connection port 3600. That is, due to the elasticity of the outer layer 3354, the outer layer 3354 can contact around the opening of the connection port 3600. The elasticity of the outer layer 3354 combined with the membrane can form a seal 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 (through friction rather than through a permanent connection). This friction fit may limit movement of the connection port 3600 so that it remains in a particular position.

[0361] 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 may make it possible to eliminate the need for a separate valve to allow excess air, oxygen, or exhaust air to be vented during use.

[0362] In other forms, the tube 3450 can be formed to have a predetermined shape (e.g., tube 3350). For example, the inner layer 3352 and outer layer 3354 can be placed around a mandrel and then heated to form a particular cross-section. These layers can then be cut and sealed so that the thermoformed inner layer 3352 and outer layer 3354 are connected to one another during the cutting process.

[0363] 5.3.3.1.2 Strap Stiffness In some embodiments, components may be formed with varying amounts of conformal membrane. In some embodiments, the conformal membrane may be specifically positioned along various surfaces. Conformal materials may be used to provide specific reinforcement in various areas of a strap or other component. For example, straps such as strap 3420 may be used to assist in securing the patient interface 3000 to the patient's face. In some embodiments, certain areas of the strap may require increased or additional support compared to other portions of the strap. Additionally, in some embodiments, the stretchability or elasticity of the strap may be limited by the use of a silicone or polyurethane membrane.

[0364] 5A-5E, a strap is illustrated. The strap includes an inner layer, a membrane layer, and an outer layer. While illustrated with the outer layer, the presence of the outer layer is not required. That is, in some configurations, the resilient inner layer 3422 and membrane layer 3424 may be used without the outer layer 3426. As shown in FIG. 5A, the strap 3420 may interact with the tube 3350 to secure the patient interface 3000 in place relative to the patient. The membrane layer 3424 is illustrated in the figures as having a substantial thickness for ease of illustration. The membrane layer 3424 may be substantially thinner than the outer layer 3426 or the inner layer 3422. For example, the membrane layer 3424 may be less than 10% of the thickness of the outer layer 3426 or the inner layer 3422.

[0365] 5B, the strap 3420 is illustrated as being isolated from the remainder of the patient interface 3000. As shown, the strap 3420 includes an outer layer 3426 and an inner layer 3422. A membrane layer 3424 is disposed between these layers and, in some configurations, connects these layers. That is, when the strap 3420 is exposed to a heat source, the membrane layer 3424 melts, changes shape, or cools, interconnecting the inner layer 3422 and the outer layer 3426. As shown in FIG. 5B, the membrane layer 3424 does not extend the entire length of the inner layer 3422. In other configurations, the membrane layer 3424 may extend the entire length of the inner layer 3422. In further configurations, one of the layers may not extend the entire distance of the strap 3420. For example, in some configurations, the outer layer 3426 may extend the same or a similar distance along the strap 3420 as the membrane layer 3424. In this example, the entire length of the outer layer 3426 may be secured to the inner layer 3422 through the use of a membrane layer 3424. Additionally, in some forms, the membrane may be bonded along the entire length of the shortest layer. A thermoplastic or thermosetting material (e.g., membrane layer 3424) may then be used to combine and bond these two layers together.

[0366] As shown in FIG. 5C , a portion of the inner layer 3422 is laminated with the membrane layer 3424. In some embodiments, the membrane layer 3424 may be formed from the same material as the woven membrane described for the tube 3350. The use of the same material in various portions of the patient interface may allow for reduced manufacturing costs compared to other embodiments. The inner layer 3422 may be formed from a resilient or stretchable material that conforms to the shape of the patient's head. Additionally, the outer layer 3426 may be constructed from the same or similar materials in the same or similar configuration. These layers may be formed from natural or rigid materials. In some embodiments, these layers may be woven fabrics, and in other embodiments, they may be rubber or plastic components. Additionally, while illustrated as being made of the same or similar materials with the same or similar properties, the inner layer 3422 and the outer layer 3426 may have different properties (e.g., stretchability, stiffness, flexibility, and other properties). The material of each layer may be selected depending on the specific properties desired for the strap 3420.

[0367] 5D and 5E, the inner layer 3422 has a different stretchability than the outer layer 3426 in areas not including the membrane layer 3424. For example, when subjected to tension T, the inner layer 3422 stretches a first distance 3428. As shown, when subjected to the same tension T, the membrane layer 3424 and the outer layer 3426 stretch a second distance 3430. The second distance 3430 is shorter than the first distance 3428. As such, the membrane layer 3424 may limit stretch in the particular area to which it is applied. That is, the membrane layer 3424 may stretch, but may reduce the distance the inner layer 3422 or the outer layer 3426 can stretch. This type of configuration may be used in particular areas requiring graded stretchability for proper support of the device. While illustrated with the outer layer 3426, in some forms of the present technology, the outer layer 3426 may not be used. The inner layer 3422 may be used for the straps without a separate layer, such as the outer layer 3426. In such a configuration, the straps may be oriented such that the membrane layer 3424 is positioned away from the patient. In this manner, the flexible texture of the inner layer 3422 may be positioned against the patient's face. Thus, the membrane layer 3424 may be used to limit stretch (without covering the outer layer 3426, etc.).

[0368] In addition to controlling the rate of stretch of a particular component, utilization of the membrane layer 3424 may also allow for control of the rate of recovery, i.e., the membrane layer 3424 may increase the ability of an elastic band, such as the strap 3420, to return to its original, unstretched state.

[0369] In some forms, the membrane layer 3424 may be used to provide structural support to the straps. In some forms, if the straps twist or rotate during use, they may move out of position, causing creases and discomfort to the patient. In these situations, the membrane may be used to support the straps and resist rotation or twisting of the straps during use.

[0370] Supporting the cushion assembly with various straps provides a proper seal from the cushion assembly to the patient's nose or mouth area. As shown in Figure 5F, the head strap 3432 is shown in association with a tube 3434 of an alternative patient interface 3436.

[0371] Referring to FIG. 5G, the head strap components are illustrated. The head strap 3432 can include various features as described above. Referring to FIG. 5H, an exploded view of the head strap 3432 is illustrated. As shown, the head strap 3432 includes an inner layer 3437, an outer layer 3438, straps 3439-3442, and a pad 3443. The inner layer 3437 and outer layer 3438 surround or sandwich some or all of the components. As shown, the inner layer 3437 and outer layer 3438 completely sandwich the pad 3443 and surround portions of the straps 3439-3442. In some forms, the inner layer 3437 and / or outer layer 3438 can be laminated with a membrane or silicone or polyurethane layer, for example, as described above for the tube 3350. After the inner layer 3437 and outer layer 3438 are aligned, they are heated to melt the membrane between them, after which the layers are bonded together. As shown, the inner layer 3437 and outer layer 3438 may also be glued or bonded to the pad 3443. In other configurations, a membrane layer may not be present within the area of ​​the pad 3443. That is, the pad 3443 may be positioned within a pocket between the inner layer 3437 and outer layer 3438, but the pad 3443 may not be physically secured to the inner layer 3437 or outer layer 3438. Furthermore, in some configurations, the straps 3439-3442 may be secured using adhesive. However, in other configurations, the straps 3439-3442 are secured to the inner layer 3437 and outer layer 3438 through the membrane.

[0372] The components of the head strap 3432 may be spaced apart in a variety of orientations. As shown in FIG. 5G , the strap 3442 is spaced apart from the strap 3441 by a portion of the inner layer 3437 and a portion of the outer layer 3438. Similarly, the strap 3442 is spaced apart from the pad 3443 by a portion of the inner layer 3437 and a portion of the outer layer 3438. A variety of other configurations may be available. For example, in some configurations, the strap 3442 may contact the strap 3441. In further configurations, the strap 3442 and the strap 3441 may be a single piece. Other variations are also possible. For example, the pad 3443 may be larger, smaller, or absent. Varying the size, shape, and orientation of the various components may allow for variation and customization of the feel of the components. As shown, there may be a variety of different stretch zones in the head strap 3432. Zone X1 includes straps 3439-3442, which have a first stretchability and may be substantially inextensible in some configurations. The second zone is zone X2, which includes straps 3439-3442 and portions of inner layer 3437 and outer layer 3438. It has a second stretchability, which may also be substantially inextensible. The third zone is zone X3, between the ends of straps 3439-3442 and pad 3443. It has a third stretchability. And finally, the final stretch zone is zone X4, which includes pad 3443 and inner layer 3437 and outer layer 3438. These various regions may be alterable according to the manufacturer's intent or desire for various properties.

[0373] 5G allows for multiple features to be present in a single head strap 3432 without the need for multiple connecting components, which can be bulky and uncomfortable. Integrating the membrane as a joining material may also allow for a reduction in the weight of the head strap compared to other configurations.

[0374] 5.3.3.2 Positioning and stabilizing structures according to further embodiments of the present technology Further examples of positioning and stabilizing structures are described below. Note that the features described below may be utilized with or combined with features described in other examples of the present disclosure. For example, the tubes described below may be used with cushion modules / assemblies described in other examples, and vice versa. Furthermore, any individual feature of the structure described in any example may be utilized with or combined with features in other examples.

[0375] 5.3.3.2.1 Headgear tubing 10 and 11 , a non-invasive patient interface 9000, 10000 according to an embodiment of the present technology may include the following functional aspects: a seal-forming structure 9100, a plenum chamber 9200, a positioning and stabilizing structure 9300, at least one vent 9400, 9400-1, and a connection port 9600 in one form for connection to an air circuit (e.g., air circuit 4170 shown in FIGS. 1A-1C ). In this example, the seal-forming structure 9100 and the plenum chamber 9200 are provided by a cushion module 9150. In this example, the cushion module 9150 is a cradle cushion module. In other examples, the cushion module 9150 may be a nasal pillows cushion module or another type of cushion module.

[0376] 10 and 11 , 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 airways, for example through the plenum chamber 9200 and the seal-forming structure 9100. In the form of the technology shown in FIGS. 10 and 11 , the positioning and stabilizing structure 9300 includes two tubes 9350 that deliver air from the air circuit 4170 to the seal-forming structure 9100. These tubes 9350 are an integral part of the positioning and stabilizing structure 9300 of the patient interface 9000 such that the seal-forming structure 9100 of the patient interface is positioned and stabilized on an appropriate portion of the patient's face (e.g., nose and / or mouth). As a result, the conduit of the air circuit 4170 that provides the pressurized air flow can be connected to the connection port 9600 of the patient interface in a location other than in front of the patient's face, which may be obscured by some people. Although a pair of tubes 9350 has several advantages (described below), in some examples the positioning and stabilizing structure 9300 includes only a single tube 9350 configured to rest on one side of the patient's head. A strap or other stabilizing component may be provided between the upper end of the single tube 9350 and the seal-forming structure 9100 on the other side of the patient's head to balance the forces on the seal-forming structure 9100.

[0377] The positioning and stabilizing structure 9300 may be described as inflatable because it is capable of containing and moving air through the headgear tubing 9350 for delivery of pressurized air from the air circuit 4170 to the patient's airway. It is 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 the example shown in Figures 10 and 11, the positioning and stabilizing structure 9300 includes headgear tubing 9350, which is inflatable, and straps 9310, which are non-inflatable.

[0378] 10 and 11, the patient interfaces 9000, 10000 may include a connection port 9600 that is positioned near the top, side, or back of the patient's head. For example, in the form of the technology shown in FIGS. 10 and 11, the connection port 9600 is positioned on top of the patient's head. In these examples, the patient interfaces 9000 and 10000 include an elbow 9610 with the connection port 9600 provided. The elbow 9610 may be rotatable (e.g., via a swivel ring 9614) relative to the positioning and stabilizing structure 9300 to allow movement of a conduit connected to the connection port 9600 to decouple it from the positioning and stabilizing structure 9300. The elbow 9610 may connect to a fluid connection opening in the headgear tubing 9350 or in a component to which the headgear tubing 9350 is connected.

[0379] Additionally or alternatively, the conduit connected to the connection port 9600 may rotate relative to the elbow 9610. In the illustrated embodiment, the elbow 9610 includes a swivel-type conduit connector including the connection port 9600 to which a conduit of the air circuit 4170 can be connected, thereby allowing the conduit to rotate about a longitudinal axis relative to the elbow 9610. In some examples, the air circuit 4170 can connect to a fluid connection opening. The elbow 9610 can be rotatably connected to the fluid connection opening or to a ring received within the fluid connection opening.

[0380] Patient interfaces in which the connection port is not located in front of the patient's face can be advantageous because some patients find it unsightly and / or uncomfortable when the conduit is connected to a patient interface in front of the face. For example, conduits connecting to a patient interface in front of the face can easily become entangled with bedding or bed linens, especially if the conduit extends downward from the patient interface during use. Forms of the present technology using patient interfaces in which the connection port is located near and above the patient's head during use may make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: on their side, in a supine position (i.e., face up), and in a prone position (i.e., face down). Furthermore, connecting the conduit to the front of the patient interface can exacerbate a problem known as tube drag. In tube drag, the conduit can generate undesirable pulling forces on the patient interface, causing it to be pulled down from the face.

[0381] 10 and 11, the positioning and stabilizing structure 9300 includes two tubes 9350. In use, each tube 9350 is positioned on a different side of the patient's head, extending through each cheek area from above each ear (above the upper ear base point on the patient's head) to the elbow 9610 at the top of the patient's 1000's head. This form of technology can be advantageous because if the patient is lying on their side and one of the tubes is compressed, blocking or partially blocking gas flow along that tube, the other tube remains open and can provide pressurized gas to the patient. In other embodiments of the technology, the patient interface 9000 can include a different number of tubes (e.g., one tube or three or more tubes). In one example where the patient interface has one tube 9350, the single tube 9350 is positioned on one side of the patient's head during use (e.g., on one cheek area), and the 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., on the other area) to help secure the patient interface 9000 on the patient's head.

[0382] In the form of the technology shown in FIGS. 10 and 11 , the two tubes 9350 are fluidly connected to each other at their upper ends and to a connection port 9600. In the embodiment shown, the tubes 9350 are separate tubes and are connected to a crown connector 9360. The tubes 9350 are indirectly connected to each other by the crown connector 9360 and can be disconnected, for example, for cleaning or storage. In another embodiment, the two tubes are integrally formed and include a fluid connection opening to which a swivel elbow is connected. In other embodiments where separate tubes are used, the tubes can be indirectly connected to each other, for example, each can be connected to a T-shaped conduit having two conduit arms each fluidly connectable to the tube 9350. The crown connector 9360 can include a third conduit arm. The connection port 9600 can include an elbow 9610 received in a fluid connection opening 9390 in the center of the crown connector 9360. The fluid connection opening 9390 may form a sealing flange 9362. The elbow 9610 may be received in a ring within the fluid connection opening 9390 and may form a seal with the sealing flange 9362 provided on the ring. The elbow 9610 may be configured to rotate within the ring. It may also be possible to consider the fluid connection opening 9390 as the connection port 9600 itself.

[0383] In some examples, the tube 9350 can be formed from a woven fabric, a spacer fabric, and / or a foam material. In some examples, the spacer fabric material itself comprises layers. The spacer fabric can comprise a woven sandwich structure. The spacer fabric can include a front layer, a back layer, and an inner spacer layer. The inner spacer layer can be formed by a fiber mesh and can include relatively open sections.

[0384] Because the intermediate layer is both highly compressible and breathable, the spacer fabric can be advantageously used to provide adequate cushioning. The intermediate layer can also be elastic. The spacer fabric can be used in the patient-contacting portion 9348 or the non-patient-contacting portion 9349 and can be an intermediate layer or an outer layer. In other examples, the tubes 9350 can be formed from a semi-rigid material such as an elastomeric material (e.g., silicone). The tubes can have a natural preformed shape, but can have at least some ability to deform or conform to the patient's head when subjected to force. For example, the tubes can generally assume an arc or curved shape that resembles the contours of the patient's head between the top of the head and the nose or mouth area.

[0385] In some examples, the positioning and stabilizing structure 9300 may include a sleeve around the tube 9350. In some examples, the patient interface 9000 may not include a sleeve, while in other examples, the patient interface 9000 may include a sleeve that covers more of the tube 9350 or all of the tube 9350. The sleeve may be formed to conform to the curved shape of the tube 9350. In some examples, the sleeve is formed from a smooth fabric. These sleeves may be more comfortable against the patient's face than a tube 9350 that is not covered at all.

[0386] As described in U.S. Patent No. 6,044,844, the entire contents of which are incorporated herein by reference, the tube 9350 may also be crush-resistant to prevent the flow of breathable gas through the tube if it is crushed during use (e.g., if crushed between the patient's face and a pillow). A crush-resistant tube is not necessary in all cases, as the pressurized gas in the tube may act as a splint to prevent or at least limit collapse of the tube 9350 during use. Using a crush-resistant tube may be advantageous when only a single tube 9350 is present, as blocking the single tube during use would restrict gas flow and stop or reduce the effectiveness of treatment.

[0387] In certain forms of the present technology, one or more regions of the tube 9350 may be stiffened with one or more stiffening or stiffening elements. Examples of stiffening elements include: a relatively thicker-walled portion of the tube 9350, a portion of the tube 9350 formed from a relatively stiffer material than the material forming the other portions of the tube, and stiffening members attached to or embedded within a portion of the tube. The use of such stiffening elements helps control how the positioning and stabilizing structure 9300 functions during use (e.g., when the tube 9350 is likely to deform when a force is applied to it, or when the tube 3350 is likely to maintain its shape when a force is applied to it). Selecting where such stiffening elements are placed within the tube 9350 can help promote comfort when wearing the patient interface 9000 and can help maintain a good seal in the seal-forming structure 9100 during use. Stiffening or stiffening elements can be placed within the positioning and stabilizing structure 9300. The positioning and stabilizing structure is configured to support a relatively heavy seal-forming structure (eg, a full face or oral-nasal cushion assembly).

[0388] In certain forms of the present technology, one or more sections of the tube 9350 may be formed from at least two sections in the length direction, with a stiffening element embedded inside or outside or within the intersection of these at least two sections.

[0389] The length of the tube 9350 in the form of the present technology shown in FIGS. 10 and 11 is 15 to 30 cm, respectively (e.g., 20 to 27 cm, respectively). The length of the tube is selected to suit the dimensions of a typical patient's head (e.g., the distance between the area near the top of the head where the upper end of the tube 9350 is located as it follows a generally arcuate path extending down the side of the head and over the patient's cheek area (e.g., the arcuate path taken by the tube 9350 as shown in FIGS. 10 and 11 ) to the area near the opening to the patient's airway where the lower end of the tube 9350 connects to the cushion module 9150). In some embodiments, the patient interface 9000 can be configured such that the length of the tube 9350 can be varied. It will be understood that the length of the tube 9350 will depend on the length of other components in the patient interface 9000 (e.g., the length of the crown connector 9360 to which the upper end of the tube 9350 connects, and / or the size of the plenum chamber 9200).

[0390] 5.3.3.2.1.1 Positioning of headgear components Each tube 9350 can be configured to receive airflow from the connection port 9600 on the patient's head and deliver the airflow to the seal-forming structure at the entrance to the patient's airway. In the example of FIGS. 10 and 11 , at least one tube 9350 extends from the connection port 9600 on the patient's cheek region and on the patient's ear between the seal-forming structure 9100 (i.e., between a portion of the tube 9350 that connects to a cushion module that covers the maxillary region of the patient's head in use and a portion of the tube 9350 that covers the region of the patient's head above the superior ear base point). One or more tubes 9350 can also each rest on the patient's sphenoid and / or temporal bone and one or both of the patient's frontal and parietal bones. The connection port 9600 and elbow 9610 can be positioned on the patient's parietal bone, frontal bone, or the junction therebetween in use.

[0391] 10 and 11 includes tubes 9350 that curve around the top of the patient's head, from where their upper ends connect to elbows 9610 on the top of the head, to where the straps 9310 connect to the tubes 9350 with relatively little curvature in the sagittal plane. Between where the rear headgear straps 9310 connect to the tubes 9350 and the lower ends of the tubes 9350 connect to cushion modules 9150 in front of the patient's airways below the nose, the tubes 9350 curve forward across the cheek area between the patient's ears and eyes. The radius of curvature of this portion of the tubes 9350 can be in the range of 60-100 mm, for example, 70-90 mm (e.g., 80 mm). The lower end of the tube 9350 and the portion of the tube 9350 where the rear headgear straps 9310 connect to the tube 9350 may be at an angle ranging from 65 to 90 degrees (e.g., 75 to 80 degrees). The actual curvature present in the section of the tube 9350 above the straps 9310 and the actual curvature in the section of the tube 9350 below the straps 9310 will depend on the patient setup and will, in fact, vary depending on the shape and size of the patient's head and the patient's preferences.

[0392] The degree to which the patient interface 9000 fits an individual patient can be altered by changing the length of the tube 9350, or alternatively or additionally, by changing the position of the patient interface 9000 on the patient's head or the position of portions thereof on the patient's head. For example, by moving portions of the positioning and stabilizing structure 9300 in a posterior or anterior direction on the patient's head, a patient interface 9000 having a particular length of tube 9350 can be adjusted to better fit the patient. For example, moving the junction of the tube 9350 further anteriorly (i.e., in an anterior direction) on the patient's head allows the patient interface 9000 having a particular length of tube 9350 to fit a larger head than if the junction of the tube 9350 were positioned further posteriorly (i.e., in a posterior direction). For most patients, when the junction of the tube 9350 is positioned anteriorly, the top of the tube 9350 will be positioned on a smaller portion of the patient's head than if the junction of the tube 9350 is positioned posteriorly. In some examples of the present technology, the tube 9350 is less flexible and the patient may have less freedom to move the top of the tube 9350 forward or backward on their head.

[0393] In certain forms of the present technology, the patient interface 9000 is configured such that the connection port 9600 can be positioned in a range of positions 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. One way this can be achieved so that the seal-forming 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 is by decoupling the movement of the upper part of the patient interface 9000 from the lower part of the patient interface 9000. Such decoupling can be achieved, for example, by forming the tube 9350 with sufficient flexibility to allow the upper part of the tube 9350 to move.

[0394] In certain forms of the present technology, the patient interface 9000 is configured so that the connection port 9600 is generally located at the top of the patient's head. The connection port 9600 may be located in the sagittal plane and aligned with the superior auricular base point in a plane parallel to the coronal plane. The superior auricular base point is shown in FIG. 2D. In some forms of the present technology, the positioning and stabilizing structure 9300 is configured to be worn in different positions, i.e., the connection port 9600 may be located near the top of the patient's head in the sagittal plane up to around 20 mm anterior or 20 mm posterior from the superior auricular base point.

[0395] In some examples of the present technology, the connection port 9600 may be positioned in the sagittal plane and aligned with the junction between the frontal and parietal bones. The connection port 9600 may be positioned generally over the junction of the coronal and sagittal sutures. In this configuration, the top of the tube 9350 may rest on and / or be positioned along a portion of the coronal suture. However, in some forms of the present technology, as described above, the patient has the ability to move the connection port 9600 forward or backward to adjust the fit of the patient interface 9000.

[0396] An advantage of placing the tube 9350 on the patient's head slightly anterior to its highest point (e.g., at or near the coronal suture) is that it reduces the risk of the tube 9350 riding posteriorly during use. In many patients, there may be a depression or "divot" where the coronal suture meets the sagittal suture. If the tube 9350 is placed within this divot, the positioning and stabilizing structure 9300 may be particularly stable. Therefore, in some instances, the tube 9350 is configured with the appropriate curvature and / or ability to curve for placement over the coronal suture.

[0397] As noted above, in some examples of the present technology, the patient interface 9000 includes a seal-forming structure 9100 in the form of a cradle cushion. The seal-forming structure 9100 is positioned generally below the nose and seals around the lower part of the nose. The 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 (with a sealing force vector having a posterior and superior direction (e.g., a posterior-superior direction)). A sealing force vector in the posterior-superior direction may encourage the seal-forming structure 9100 to form a good seal on either side of the patient's nose and upper lip against both the lower part of the patient's nose and the anterior surface of the patient's face.

[0398] In some examples, when in use, the positioning and stabilizing structure 9300 may apply a sealing force vector having a posterior-superior direction relative to the patient's Frankfort horizontal (as depicted in FIG. 2E ) at an angle of approximately 35°. The upper part of the tube 9350 (e.g., the portion of the tube 9350 above the strap 9310) may be oriented vertically, and the rear headgear straps 9310 may extend in a posterior-inferior direction from the tube 9350 at an angle of approximately 35° relative to the patient's Frankfort horizontal. In one example, where the strap 9310 connects to the tube 9350, an angle of approximately 125° is formed between the strap 9310 and the upper part of the tube 9350.

[0399] In some examples, the positioning and stabilizing structure 9300 can be configured so that the top of the tube 9350 rests on the patient's head slightly anterior to its highest point. As a result, for some patients, the tube 9350 may be angled slightly anteriorly rather than aligned vertically (e.g., in the coronal plane), such that it is positioned within a slight recess at or near the coronal suture of the skull. In such examples, the tension in the straps 9310 can be adjusted by the patient to balance the forces and achieve an optimal sealing force vector.

[0400] In some examples, the positioning and stabilizing structure 9300 can be configured to apply a force on the seal-forming structure 9100 in a posterior-superior direction at an angle that bisects the angle formed between the upper lip and the columella (e.g., the surface forming the nasolabial angle).

[0401] In a particular example of the present technology, the tubes 9350 are configured to receive the straps 9310 at positions above and near the patient's ears. If the straps 9310 are connected to the tubes 9350 too high on the patient's head, the straps 9310 may tend to ride up on the back of the patient's head. Furthermore, the straps 9310 may form too great an angle with the top of the headgear tubes 9350, which may result in the patient needing to overtighten the straps 9310, which may create excessive tension in the positioning and stabilizing structure 9300 and increase the likelihood that the straps 9310 will ride up on the back of the patient's head. Therefore, it is advantageous to position the connection between the straps 9310 and the tubes 9350 as low as possible while still being spaced far enough from the top of the patient's ears so that the tubes 9350 are not pulled into contact with the patient's ears when the straps 9310 are fastened.

[0402] 5.3.3.2.1.2 Headgear tubing fluid connections The two tubes 9350 are fluidly connected at their lower ends to the plenum chamber 9200. In the example of FIGS. 10 and 11, the tubes 9350 form a fluid connection with the cushion module 9150 and the seal-forming structure 9100. In certain forms of the present technology, the connection between the tubes 9350 and the cushion module 9150 is achieved by connecting two rigid components such that the patient can easily connect the two rigid components in a reliable manner. Tactile feedback such as a "confirmable click" or similar sound can be used to facilitate use by the patient and also let the patient know when the tubes are properly connected to the cushion module 9150. In one form, the tubes 9350 are formed from a fabric and foam material, and the lower ends of each of the tubes 9350 are overmolded or bonded to a rigid connector formed from, for example, polypropylene, polycarbonate, nylon, or the like. The rigid connectors can include male mating features configured to connect to female mating features on the cushion module 9150. Alternatively, the rigid connector may include a female mating feature configured to connect to a male mating feature on the cushion module 9150. The manner in which the tube 9350 is connected to the cushion module 9150 can also be applied to connections between the tube 9350 and another plenum chamber 9200 or seal-forming structure 9100 (e.g., a nasal pillow cushion module).

[0403] If the engagement between the tube 9350 and the port is a rigid-to-rigid type engagement, a pressure activated seal such as a peripheral sealing flange may be used. When pressurized gas is supplied through the tube 9350, the sealing flange is urged against the joint between the tube and the inner periphery of the port in the plenum chamber 9200, promoting a seal therebetween. If the port is flexible and a rigid connector is provided to the tube 9350, a pressure activated seal such as those described above may also be used to ensure the connection is airtight.

[0404] In some forms of the present technology, a similar connection mechanism may be used to fluidly connect the tubing 9350 to the crown connector 9360, which is fluidly connected to the connection port 9600. In one embodiment, the swivel elbow connected at the connection port 9600 is rotatable, such that this rotation actuates a port size adjustment mechanism that increases or decreases the size of the port into which the tubing 9350 is inserted, thereby improving the fit of the tubing through increased or decreased compression force and reducing unintended leakage.

[0405] 5.3.3.2.1.3 Extendable bellows structure The patient interface 9000 may include one or more extendable tubing sections. In some examples, the extendable tubing sections include an extendable bellows structure. The patient interface 9000 may include a positioning and stabilizing structure 9300 that includes at least one gas delivery tube that includes a tube wall having an extendable bellows structure.

[0406] 5.3.3.2.1.4 Flexibility In some examples of the present technology, portions of the positioning and stabilizing structure 9300 are configured to withstand bending in or around some directions or on or around some axes more than bending in or around some directions or on or around some axes.

[0407] For example, the upper portion of each tube 9350 of the positioning and stabilizing structure 9300 shown in FIGS. 10 and 11 may be more flexible in a particular direction than in an orthogonal direction. Each gas delivery tube 9350 of the positioning and stabilizing structure 9300 may include an upper tube section 9304 configured to rest on the upper region of the patient's head during use. In some examples of the present technology, the upper tube section 9304 may include an extendable tube structure (e.g., one of the options disclosed in PCT Patent Publication No. WO 2017 / 124155 or U.S. Patent Application No. 62 / 764,995, the contents of each of which are incorporated by reference herein in their entirety) or may be non-extendable. In the exemplary form of the technology shown in FIGS. 10 and 11, the tube is substantially non-extendable, thereby preserving any inherent stretchability of the material(s) forming the tube.

[0408] The upper tube portion 9304 includes a first end 9305 and a second end 9306. In this example, the first end 9305 is configured to rest or be positioned on the top of the patient's head, approximately in the sagittal plane of the patient's head (e.g., approximately at the top and center of the patient's head). The second end 9306 is configured to rest laterally of 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 positioned laterally and inferiorly relative to the first end 9305. The positioning and stabilizing structure 9300 of FIGS. 10 and 11 is bendable, at least to a certain extent, about multiple axes. For example, the upper tube portion 9304 of the positioning and stabilizing structure 9300 may be draped over the patient's head and may be curved in the anterior and posterior directions.

[0409] In some examples of the present technology, the upper tube portion 9304 may also include one or more rigid portions between the first end 9305 and the second end 9306. The rigid portion(s) may be configured to provide higher resistance to relative movement between the first end 9305 and the second end 9306 in the forward and / or backward directions rather than in the upward and / or downward directions. In some examples, these rigid portions may be provided throughout the length of the tube 9350, which in some examples may allow for varying the stiffness of the tube 9350 along the length of the tube 9350.

[0410] When the positioning and stabilizing structure 9300 is worn by a patient, the upper tube portion 9304 may have a 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 "drape down" from the top of the patient's head to the sides of the patient's head. Bendability in the upward / downward directions may be advantageous in allowing the upper tube portion 9304 to conform to the curvature of the patient's head.

[0411] Furthermore, the upper tube portion 9304 may have a relatively high resistance to bending in the horizontal direction, thereby preventing inadvertent forward and / or rearward movement of the first end 9305 relative to the second end 9306. As a result, the upper tube portion 9304 may advantageously be maintained in a desired position over the top of the patient's head. A low resistance to forward and / or rearward bending may reduce the likelihood that the upper tube portion 9304 (and particularly the connection port 9600) will ride forward or rearward along the top of the patient's head during use. Such resistance to forward or rearward movement of the upper tube portion 9304 is particularly advantageous for patient interface 9000 where there is a connection from the air circuit 4170 to the top of the patient's head (i.e., tube drag may act directly on the upper tube portion 9304).

[0412] In some examples, the upper tube portion 9304 can include a shape that inherently provides advantageous resistance to bending. For example, the upper tube portion 9304 can include a slightly rectangular or trapezoidal cross-section, with parallel long sides configured to rest against the surface of a patient's head. The long sides of the rectangular cross-section provide relatively high resistance to bending of the upper tube portion in directions parallel to the long sides (e.g., forward and / or backward in use). However, the short sides of the rectangular / trapezoidal cross-section do not provide such high resistance to bending of the upper tube portion 9304 and in directions parallel to the short sides (e.g., downward and / or upward in use).

[0413] It is understood that the cross section of the upper tube portion 9304 need not be a perfect rectangle. For example, the corners and / or short sides may be curved to make the cross section of the upper tube portion 9304 substantially oval or elliptical. However, a cross-sectional shape that exhibits a flat surface of the tube on the side that faces and contacts other parts of the patient's face or head may be more comfortable to wear than, for example, a tube having a circular cross section.

[0414] These stiffening sections may be formed by one or more stiffening structures formed by or on the wall of the tube 9350. A tube 9350 that includes stiffening sections on both the front and back of the tube 9350 may advantageously have higher resistance to bending in both the front and back of the tube 9350. However, in some instances, stiffening sections may be provided on only the front or back of the tube 9350, where the stiffness may be such that a stiffening section on only one side provides sufficient resistance to bending in both directions.

[0415] In some examples, a portion of the tube 9350 (e.g., the front and / or rear) can include a rigid portion stiffe...

Claims

1. A patient interface comprising: At least 6 cmH above ambient air pressure ２ a plenum chamber pressurizable to a therapeutic pressure of O, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes therein whereby an air flow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; and a positioning and stabilizing structure that provides a force to hold 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 conduit for delivering said air flow through said seal-forming structure to an entrance of said patient's airway, said at least one gas delivery conduit constructed and arranged in use to contact at least an area of ​​said patient's head above an upper ear-base point of said patient's head; A patient interface, wherein the at least one gas delivery tube includes an inner textile layer and an outer textile layer, the inner textile layer having a substantially planar cross-sectional shape and the outer textile layer having a predetermined non-planar cross-sectional shape, the outer textile layer being elastic such that when subjected to an external force, the cross-sectional shape of the outer textile layer changes and when the external force is released, the outer textile layer returns to the predetermined non-planar cross-sectional shape.

2. The patient interface of claim 1 , wherein the inner textile layer has different material properties than the outer textile layer.

3. 3. A patient interface according to claim 1 or 2, wherein the inner textile layer includes an internal textile membrane configured, when pressurized with air in use, to allow air movement therethrough.

4. 4. A patient interface according to any one of claims 1 to 3, wherein the inner textile layer comprises a conforming inner textile membrane and the outer textile layer comprises a conforming outer textile membrane, the outer textile layer being thicker than the inner textile layer.

5. A patient interface according to any preceding claim, wherein the inner textile layer is joined to the outer textile layer along at least one edge of the gas delivery tube to form a tubular shape.

6. A patient interface according to any preceding claim, wherein the inner textile layer is flexible.

7. A patient interface according to any preceding claim, wherein the inner textile layer is secured to the outer textile layer and tension is applied onto the inner textile layer from the outer textile layer.

8. 8. A patient interface according to any preceding claim, wherein the inner textile layer comprises an outer textile sheet and an inner textile membrane, the inner textile membrane being configured to resist air movement through the outer textile sheet.

9. A patient interface according to any preceding claim, wherein the at least one gas delivery conduit is configured to extend continuously from the patient's right side along the parietal bone to the patient's left side.

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

11. 11. A patient interface according to any preceding claim, wherein the outer textile layer comprises an outer textile sheet and an inner textile membrane, the conformable sheet being sandwiched between the outer textile sheet and the inner textile membrane.

12. 12. A patient interface according to any one of claims 1 to 11, wherein the inner textile layer is joined to the outer textile layer at a juncture, the width of the juncture varying along the length of the at least one gas delivery tube.

13. A patient interface according to any preceding claim, wherein the outer textile layer has an inner surface, the inner surface of the outer textile layer having a positive curvature.

14. A patient interface according to any preceding claim, wherein the inner textile layer has zero curvature.

15. A patient interface according to any preceding claim, wherein the inner and outer textile layers are joined together without sutures.

16. 16. A patient interface according to any one of claims 1 to 15, wherein the inner textile layer comprises an inner internal textile membrane and the outer textile layer comprises an outer internal textile membrane, the outer internal textile membrane of the outer textile layer and the inner internal textile membrane of the inner textile layer being joined together along an edge of the at least one gas delivery tube, the inner internal textile membrane and the outer internal textile membrane joining the inner textile layer to the outer textile layer and forming an air impermeable membrane between the inner textile layer and the outer textile layer.

17. 17. A patient interface according to any one of claims 1 to 16, wherein the inner and outer textile layers are joined at a first edge by a first junction and at a second edge by a second junction, are spaced apart from one another between the first junction and the second junction, and no stiffening is used along the inner textile layer between the first junction and the second junction.

18. A patient interface according to any preceding claim, wherein in use, when pressurised with air, the inner textile layer expands away from the outer textile layer.

19. A patient interface according to any preceding claim, wherein the outer textile layer comprises a conformable material, the conformable material being heat formed to the non-planar cross-sectional shape.

20. 20. A patient interface according to any one of claims 1 to 19, wherein the at least one gas delivery conduit is thermoformed to a predetermined shape such that a first arm extends along a first plane and a top portion extends without external force or pressure along a second plane substantially perpendicular to the first plane.

21. A patient interface comprising: At least 6 cmH above ambient air pressure ２ a plenum chamber pressurizable to a therapeutic pressure of O, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes therein whereby an air flow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; and a positioning and stabilizing structure that provides a force to hold 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 conduit for delivering said air flow through said seal-forming structure to an entrance of said patient's airway, said at least one gas delivery conduit constructed and arranged in use to contact at least an area of ​​said patient's head above an upper ear-base point of said patient's head; the at least one gas delivery tube includes an inner woven layer and an outer woven layer, the inner woven layer and the outer woven layer being joined at a first junction along a first longitudinal edge and joined at a second junction along a second longitudinal edge; the outer textile layer is spaced apart from the inner textile layer between the first and second joints; the outer textile layer is heat formed to a predetermined shape and the inner textile layer is not heat formed; a patient interface, wherein the outer textile layer supports its own weight between the first bond and the second bond, such that the outer textile layer remains spaced apart from the inner textile layer when not supported by pressurized air.

22. 22. The patient interface of claim 21, wherein the inner textile layer has different material properties than the outer textile layer.

23. 23. A patient interface according to claim 21 or 22, wherein the inner textile layer includes an inner textile membrane, the inner textile membrane configured, in use, when pressurized with air to allow air movement therethrough.

24. 24. A patient interface according to any one of claims 21 to 23, wherein the inner textile layer comprises a conforming inner textile membrane and the outer textile layer comprises a conforming outer textile membrane, the outer textile layer being thicker than the inner textile layer.

25. A patient interface according to any one of claims 21 to 24, wherein the inner textile layer has a substantially planar cross-section.

26. A patient interface according to any one of claims 21 to 25, wherein the inner textile layer is flexible.

27. A patient interface according to any one of claims 21 to 26, wherein the inner textile layer is secured to the outer textile layer and tension is applied onto the inner textile layer from the outer textile layer.

28. 28. A patient interface according to any one of claims 21 to 27, wherein the inner textile layer includes an outer textile sheet and an inner textile membrane, the inner textile membrane configured to resist air movement through the outer textile sheet.

29. A patient interface according to any one of claims 21 to 28, wherein the at least one gas delivery conduit is configured to extend from the patient's right side continuously along the parietal bone to the patient's left side.

30. 30. A patient interface according to any one of claims 21 to 29, wherein the at least one gas delivery conduit includes an air supply conduit, the air supply conduit being positioned adjacent to a parietal bone when the patient interface is worn by the patient.

31. 31. A patient interface according to any one of claims 21 to 30, wherein the outer textile layer comprises an outer textile sheet and an inner textile membrane, the conformable sheet being sandwiched between the outer textile sheet and the inner textile membrane.

32. 32. A patient interface according to any one of claims 21 to 31, wherein the inner textile layer is joined to the outer textile layer at a juncture, the width of the juncture varying along the length of the at least one gas delivery tube.

33. 33. A patient interface according to any one of claims 21 to 32, wherein the outer textile layer has an inner surface, the inner surface of the outer textile layer having a positive curvature between the first junction and the second junction.

34. A patient interface according to any one of claims 21 to 33, wherein the inner textile layer has zero curvature between the first junction and the second junction.

35. A patient interface according to any one of claims 21 to 34, wherein the inner and outer textile layers are joined together without sutures.

36. 36. A patient interface according to any one of claims 21 to 35, wherein the inner textile layer comprises an inner internal textile membrane and the outer textile layer comprises an outer internal textile membrane, the outer internal textile membrane of the outer textile layer and the inner internal textile membrane of the inner textile layer being joined together along an edge of the at least one gas delivery tube, the inner internal textile membrane and the outer internal textile membrane joining the inner textile layer to the outer textile layer and forming an air impermeable membrane between the inner textile layer and the outer textile layer.

37. 37. A patient interface according to any one of claims 21 to 36, wherein the inner and outer textile layers are joined at a first edge by a first junction and at a second edge by a second junction, are spaced apart from one another between the first junction and the second junction, and no stiffening is used along the inner textile layer between the first junction and the second junction.

38. A patient interface according to any one of claims 21 to 35, wherein in use, when pressurised with air, the inner textile layer expands away from the outer textile layer.

39. 39. A patient interface according to any one of claims 21 to 38, wherein the outer textile layer comprises a conformable material, the conformable material being heat formed to have a predetermined non-planar cross-sectional shape.

40. 40. A patient interface according to any one of claims 21 to 39, wherein the at least one gas delivery conduit is thermoformed to a predetermined shape such that a first arm extends along a first plane and a top portion extends without external force or pressure along a second plane substantially perpendicular to the first plane.

41. A patient interface comprising: At least 6 cmH above ambient air pressure ２ a plenum chamber pressurizable to a therapeutic pressure of O, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes therein whereby an air flow at said therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; and a positioning and stabilizing structure that provides a force to hold 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 conduit for delivering said air flow through said seal-forming structure to an entrance of said patient's airway, said at least one gas delivery conduit constructed and arranged in use to contact at least an area of ​​said patient's head above an upper ear-base point of said patient's head; the at least one gas delivery tube includes an inner woven layer and an outer woven layer, the outer woven layer being stiffer than the inner woven layer; the inner and outer textile layers are joined along a first longitudinal edge and a second longitudinal edge; A patient interface wherein an air passageway is formed between the inner and outer textile layers.

42. 42. A patient interface as described in claim 41, wherein the outer textile layer has a predetermined non-planar cross-sectional shape, the outer textile layer being elastic such that when subjected to an external force, the outer textile layer changes shape and when the external force is released, the outer layer returns to the predetermined non-planar cross-sectional shape.

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

44. 44. A patient interface according to any one of claims 41 to 43, wherein the inner textile layer includes an internal textile membrane configured, in use, when pressurized with air to allow air movement therethrough.

45. 45. A patient interface according to any one of claims 41 to 44, wherein the inner textile layer comprises a conforming inner textile membrane and the outer textile layer comprises a conforming outer textile membrane, the outer textile layer being thicker than the inner textile layer.

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

47. A patient interface according to any one of claims 41 to 46, wherein the inner textile layer is flexible.

48. 48. A patient interface according to any one of claims 41 to 47, wherein the inner textile layer is secured to the outer textile layer and tension is applied onto the inner textile layer from the outer textile layer.

49. 49. A patient interface according to any one of claims 41 to 48, wherein the inner textile layer includes an outer textile sheet and an inner textile membrane, the inner textile membrane configured to resist air movement through the outer textile sheet.

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

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

52. 52. A patient interface according to any one of claims 41 to 51, wherein the outer textile layer comprises an outer textile sheet and an inner textile membrane, the conformable sheet being sandwiched between the outer textile sheet and the inner textile membrane.

53. 53. A patient interface according to any one of claims 41 to 52, wherein the inner textile layer is joined to the outer textile layer at a juncture, the width of the juncture varying along the length of the at least one gas delivery tube.

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

56. 56. A patient interface according to any one of claims 41 to 55, wherein the inner and outer textile layers are joined together without sutures.

57. 57. A patient interface according to any one of claims 41 to 56, wherein the inner textile layer comprises an inner internal textile membrane and the outer textile layer comprises an outer internal textile membrane, the outer internal textile membrane of the outer textile layer and the inner internal textile membrane of the inner textile layer being joined together along an edge of the at least one gas delivery tube, the inner internal textile membrane and the outer internal textile membrane joining the inner textile layer to the outer textile layer and forming an air impermeable membrane between the inner textile layer and the outer textile layer.

58. 58. A patient interface according to any one of claims 41-57, wherein the inner and outer textile layers are joined at a first edge by a first junction and at a second edge by a second junction, are spaced apart from one another between the first junction and the second junction, and no stiffening is used along the inner textile layer between the first junction and the second junction.

59. A patient interface according to any one of claims 41 to 58, wherein in use when pressurised with air the inner textile layer expands away from the outer textile layer.

60. 60. A patient interface according to any one of claims 41 to 59, wherein the patient interface is configured to allow the patient to breathe from atmosphere through their oral cavity in the absence of pressurized air flow through the plenum chamber inlet port or alternatively, the patient interface is configured to leave the patient's oral cavity exposed.

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

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

63. A patient interface according to any one of claims 41 to 62, wherein, in use, the seal-forming structure is configured so that it does not extend under the chin rise area.

64. 64. A patient interface according to any one of claims 41 to 63, wherein the plenum chamber is constructed and arranged so as not to cover the eye in use.

65. In use, the positioning and stabilizing structure provides a radiation energy of at least (6 (g-f / cm ２ ) x mask occupation area (cm ２ 65. A patient interface according to any one of claims 41 to 64, configured to provide a retention force of

66. In use, the positioning and stabilizing structure provides a thermal shock absorber with a thermal shock absorber capacity of 30 (g-f / cm ２ ) x mask occupation area (cm ２ 66. A patient interface according to any one of claims 41 to 65, configured to provide a force of less than

67. A patient interface according to any one of claims 41 to 66, wherein a portion of the positioning and stabilising structure is constructed to be breathable so as to allow water vapour to escape and / or pass through.

68. A positioning and stabilising structure that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, said seal-forming structure providing an air flow at least 6cmH above ambient air pressure throughout the patient's respiratory cycle in use. ２ and a positioning and stabilizing structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airway for sealed delivery at a therapeutic pressure of O, said positioning and stabilizing structure comprising: At least one gases delivery conduit for receiving an air flow from a connection port on a patient's head and delivering the air flow through a seal-forming structure to an entrance of the patient's airway, said gases delivery conduit constructed and arranged in use to contact at least an area of ​​the patient's head above an upper ear-base point of the patient's head, said gases delivery conduit including a conduit wall defining a hollow interior adapted for air flow to the seal-forming structure, said conduit wall comprising: a patient contacting portion including a first outer layer including a fabric or foam material configured to be positioned against the patient's head in use; a non-patient contacting portion including a second outer layer on the gas delivery tube opposite the first outer layer, the second outer layer including a woven or foam material; A positioning and stabilizing structure, wherein the patient contacting portion is more rigid than the non-patient contacting portion.

69. 69. The positioning and stabilizing structure of claim 68, wherein the patient contacting portion is thicker than the non-patient contacting portion.

70. 70. The positioning and stabilizing structure of claim 68 or 69, wherein the patient-contacting portion is thermoformed by a first heat-molding process and the non-patient-contacting portion is thermoformed by a second heat-molding process, the first heat-molding process imparting a higher stiffness to the patient-contacting portion than the stiffness imparted to the non-patient-contacting portion from the second heat-molding process.

71. The positioning and stabilising structure of any one of claims 68 to 70, wherein the patient contacting portion and the non-patient contacting portion are each formed by layers, the patient contacting portion including a greater number of layers than the non-patient contacting portion.

72. The positioning and stabilising structure of any one of claims 68 to 71, wherein the patient contacting portion comprises a stiffening layer.

73. The positioning and stabilising structure of any one of claims 68 to 72, wherein the patient contacting portion comprises a stiffening member.

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

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