Air Delivery Conduit

Abstract

Methods of manufacturing components and devices for providing respiratory pressure therapy, and components manufactured according to said methods. A support structure is provided for the component. In embodiments, the support structure can be a rigid ring. Alternatively, a resilient material is added to the component to create a resilient reinforcement element. These devices and components include a conduit for delivering a flow of pressurized gas to a patient interface, a positioning and stabilizing structure having a headgear tube with a support element, and a patient interface including the conduit.

Description

[Technical Field]

[0001] 1 Cross-reference to related applications Australian Patent Application No. 2019901704 (filed May 20, 2019), Australian Patent Application No. 2019902721 (filed July 30, 2019) and Singapore Patent Application No. 1020200432U (filed May 11, 2020), the contents of which are incorporated herein by reference in their entirety.

[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. [Background technology]

[0003] 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.

[0004] 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 right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and ultimately into alveoli. Gas exchange occurs in the alveolar region of the lung, which is called the respiratory region. See: "Respiratory Physiology," by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0005] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

[0006] 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.

[0007] 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 200 to 300 times per night. This can result in excessive daytime sleepiness, which can lead 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. Patent No. 4,944,310 (Sullivan).

[0008] 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 nervous activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0009] 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:

[0010] Patients with respiratory failure (a type of respiratory insufficiency) may experience unusual shortness of breath during exercise.

[0011] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0012] 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.

[0013] 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.

[0014] 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.

[0015] A range of treatments are available to treat or ameliorate these conditions, and preventative treatments for respiratory disease are also available to benefit otherwise healthy individuals. However, these suffer from several deficiencies.

[0016] 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).

[0017] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that continuous positive airway pressure acts 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: uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0018] 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.

[0019] 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.

[0020] 2.2.3 Treatment System These treatments may be provided by therapeutic systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.

[0021] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0022] Another form of treatment system is a mandibular repositioning device.

[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 one's side in bed with one's 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 is highly effective in treating certain respiratory conditions when patients comply with the therapy. However, if the mask is uncomfortable or difficult to use, patients may not comply. Patients are often encouraged to clean their masks regularly, but if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients 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 nose bridge region of the face. In one form of patient interface, the seal-forming structure can include an element that surrounds the oral cavity 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 can leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming portion can 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 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

[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 WO 2004 / 073,778 (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 WO 2005 / 063,328 and WO 2006 / 130,903 (which describe, among other things, aspects of ResMed Limited's MIRAGE LIBERTY® Full Face Mask); and International Patent Application WO 2009 / 052,560 (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 involves the use of one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following problems: poor fit, bulky, uncomfortable, and cumbersome.

[0047] 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 above-mentioned therapies, for example, by actuating the device to generate a delivery flow of air to an interface with the airway. This air flow can be pressurized. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0048] 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.

[0049] One example of a special requirement for a particular RPT device is acoustic noise.

[0050] Table of noise output levels of conventional RPT devices (measured on one sample only at 10cmH2O in CPAP mode using the test method specified in ISO3744). [Table 1]

[0051] 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.

[0052] The ResMed Elis Accent-Aiguée® 150 ventilator and ResMed VSIII® ventilators can provide invasive and non-invasive dependent respiratory support suitable for adult or pediatric patients for the treatment of multiple conditions. These ventilators offer volumetric 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.

[0053] 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.

[0054] Air circuit Conventional air circuits for respiratory pressure therapy often include corrugated plastic tubing that feels hard against the skin, often with a spiral plastic support structure and plastic film.

[0055] 2.2.3.3 Humidifier Delivery of 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 of 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.

[0056] A range of artificial humidification devices and systems are known, but do not meet the special requirements of medical humidifiers.

[0057] 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.

[0058] 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.

[0059] 2.2.3.4 Data Management 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.

[0060] There may be other aspects of patient care that benefit from communication of treatment data to third parties or external systems.

[0061] Existing processes for communicating and managing such data can be costly, time consuming, and / or error prone.

[0062] 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.

[0063] 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.

[0064] 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.

[0065] 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.

[0066] 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).

[0067] 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.

[0068] 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.

[0069] Conventional mask noise table (ISO17510-2:2007, 10cmH2O pressure at 1m) [Table 2]

[0070] (*Measured using only one sample at 10cmH2O in CPAP mode using the test method specified in ISO3744) The sound pressure values ​​of various objects are listed below [Table 3] [Prior art documents] [Patent documents]

[0071] [Patent Document 1] U.S. Patent No. 4,944,310 [Patent Document 2] U.S. Patent No. 6,532,959 Summary of the Invention [Problem to be solved by the invention]

[0072] 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. [Means for solving the problem]

[0073] A first aspect of the present technology relates to devices used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disease.

[0074] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0075] An aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.

[0076] Another aspect of certain forms of the present technology is to provide improved methods and techniques for manufacturing devices and components thereof used in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders.

[0077] Another aspect of the present technology is to provide devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders, and may enable the promotion of the use of improved manufacturing methods and technologies.

[0078] One aspect of the present technology relates to air delivery conduits that are more comfortable and visually appealing.

[0079] Another aspect of the present technology relates to an air delivery conduit comprising a woven fabric.

[0080] Another aspect of the present technology relates to an air delivery conduit that is quiet, unobtrusive, and / or attractive to the patient. The air delivery conduit may comprise a woven fabric.

[0081] Another aspect of the present technology relates to air delivery conduits configured to elongate or meet. The air delivery conduits may be configured to elongate or meet without kinking.

[0082] Another aspect of the present technology relates to an air delivery conduit that includes an airtight fabric.

[0083] Another aspect of the present technology includes an air delivery conduit that includes an outer surface formed from a woven fabric and an inner surface formed from an air impermeable material.

[0084] Another aspect of the present technology includes an air delivery conduit including a reinforcing structure. The reinforcing structure may include a plurality of ring members.

[0085] Another aspect of the present technology involves an air delivery conduit laminate comprising a woven fabric.

[0086] Another aspect of the present technology includes an air delivery conduit including a facing and a sealing layer configured to seal the facing.

[0087] Another aspect of the present technology includes an air delivery conduit that is less invasive and uses fabric, making it more attractive to patients, leading to improved treatment compliance.

[0088] Another aspect of the present technology includes an air delivery conduit that is lightweight and / or exerts low tube drag on the patient interface.

[0089] Another aspect of the present technology includes an air delivery conduit in the form of a stub tube at a patient interface, the stub tube being configured to connect to a hose connected to a respiratory pressure therapy device.

[0090] Another aspect of the present technology includes an air delivery conduit in the form of an elongated tube configured to connect directly to a respiratory treatment device at a first end and to a patient interface at a second end.

[0091] Another aspect of the present technology includes a patient interface that includes an air delivery tube in the form of a short tube, according to an example of the present technology.

[0092] Another aspect of the present technology relates to a patient interface assembly that includes a patient interface configured to sealingly engage a patient's face and an air delivery conduit connectable to the patient interface, the air delivery conduit may include a woven material.

[0093] Another aspect of the present technology relates to a respiratory treatment system including a respiratory pressure treatment (RPT) device configured to pressurize a flow of respiratory gas. The respiratory treatment system also includes an air delivery tube connectable to the RPT. The air delivery tube may include a woven material.

[0094] Another aspect of the present technology includes an air delivery conduit that includes an outer layer formed from a woven fabric that includes one or more first regions and one or more second regions, and that can be heat-treated to cause a change in the properties of the second regions.

[0095] Another aspect of the present technology includes an air delivery conduit that includes an outer layer formed from a fabric including a cured fiber network. The cured fiber network can be hardened by a curing process. The cured fiber network can be cured by a heat treatment. The cured fiber network can include fibers formed from a thermoplastic material or a thermosetting material.

[0096] Another aspect of the present technology includes an air delivery conduit that includes an outer layer formed from a woven fabric, the outer layer including a first region having a first stiffness and a second region having a second stiffness greater than the first stiffness, and the outer layer can include a plurality of first regions and a plurality of second regions that are arranged alternately along the length of the outer layer.

[0097] Another aspect of the present technology includes an air delivery conduit including an outer layer formed from a woven fabric, the woven fabric including one or more sections at least partially woven from heat-activated yarns. The heat-activated yarns may include fibers that are at least partially melted relative to surrounding fibers. The heat-activated yarns may include fibers that are at least partially cured.

[0098] According to an example of the present technology, another aspect of the present technology includes a system for respiratory pressure therapy that includes a respiratory pressure therapy device, a patient interface, and an air delivery conduit.

[0099] Another aspect of the present technology includes an air delivery conduit configured to convey a flow of air under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient, the air delivery conduit including: a flexible reinforcing structure along the length of the air delivery conduit; an air impermeable covering disposed on the reinforcement structure along the length of the air delivery conduit, the covering forming an enclosed air path through which air flow can be conveyed in use, the air impermeable covering comprising: a sealing layer provided on the flexible reinforcing structure; a sheet covering a periphery of the reinforcing structure, the sheet including a first edge and a second edge, the first edge and the second edge extending along the air delivery conduit, an outer side and an inner side, respectively, the inner side of the sheet including: a first portion on a first side of the first edge adjacent the first edge; and a second region adjacent the first edge, the second region being on a second side of the first edge opposite the first side; The sealing layer seals between a first portion of the interior of the sheet and a second portion of the interior of the sheet.

[0100] In examples: (a) the inside of the sheet adjacent the second edge is bonded to the sealing layer; (b) the inside of the sheet adjacent the second edge is bonded to the outside of the sheet adjacent the first edge; (c) the sealing layer is bonded to the reinforcing structure; (d) the sheet is bonded to the sealing layer; (e) the sealing layer comprises a thermoplastic material; (f) the sealing layer comprises a thermoplastic polyurethane; (g) the sealing layer is thermally bonded to the reinforcing structure and / or the sheet; (h) the sealing layer is bonded to the reinforcing structure and / or the sheet; (i) the air delivery conduit comprises an outer strip bonded to the outside of the woven sheet across and along the second edge of the sheet; (j) the outer strip comprises flexible tape; and / or (k) the outer strip comprises a woven material.

[0101] In examples: (a) the sheet comprises a laminate; (b) the sheet comprises an outer layer comprising a woven material and an inner layer comprising an air-impermeable material; (c) the air-impermeable material comprises a thermoplastic material; (d) the air-impermeable material comprises a thermoplastic polyurethane; (e) the outer and inner layers are joined together by a dot adhesive lamination; (f) the sealing layer comprises a sealing strip extending along the length of the air delivery conduit; (g) the sheet is joined to the sealing strip, and a first edge of the sheet is positioned along the sealing strip and adjacent a centerline along the sealing strip; (h) the inner side of the sheet adjacent the second edge is joined to the outer side of the sheet adjacent the first edge, and the second edge is spaced from the first edge such that the sheet overlaps the second edge; and / or (i) the second edge of the sheet comprises a sawtooth profile configured to resist peeling the second edge of the sheet away from the outer side of the sheet.

[0102] In examples: (a) the reinforcing structure includes a plurality of support structures spaced apart along the length of the air delivery conduit; (b) each support structure takes the form of a ring member; (c) the reinforcing structure includes one or more helical members; (d) the air delivery conduit includes a first end configured to connect to tubing connected to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface; and / or (e) the air delivery conduit includes a first end configured to connect to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface.

[0103] In the example: the inner side of the sheet adjacent the second edge is bonded to the sealing layer.

[0104] In the example: the inside of the sheet adjacent the second edge is joined to the outside of the sheet adjacent the first edge.

[0105] In the example: the sealing layer is bonded to the reinforcing structure.

[0106] In the example: the sheet is bonded to a sealing layer.

[0107] In an example: the sealing layer comprises a thermoplastic material.

[0108] In an example: the sealing layer is heat bonded to the reinforcing structure and / or sheet.

[0109] In an example: the air delivery conduit comprises an outer strip joined to the outside of the sheet across and along the second edge of the sheet.

[0110] In examples: sheets include laminates.

[0111] In an example: the sheet comprises an outer layer comprising a textile material.

[0112] In an example: the sealing layer comprises a sealing strip extending along the length of the air delivery conduit.

[0113] In the example: the sheets are joined to the sealing strip and the first edge of the outer sheet is positioned along the sealing strip adjacent to a centerline along the sealing strip.

[0114] In an example: the inside of the sheet adjacent the second edge is joined to the outside of the sheet adjacent the first edge, and the second edge is spaced apart from the first edge so that the sheet overlaps with the second edge.

[0115] In an example: the second edge of the sheet includes a serrated profile configured to resist peeling the second edge of the sheet away from the outer side of the sheet.

[0116] In an example: the reinforcing structure includes a plurality of support structures spaced along the length of the air delivery conduit.

[0117] In an example: the air delivery conduit includes a first end configured to connect to tubing connected to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface. Another aspect of the present technology includes an air delivery conduit configured to carry a flow of air under pressure from the respiratory pressure treatment device to a patient interface for providing respiratory pressure treatment to the patient, the air delivery conduit including: A flexible reinforcing structure is provided along the length of the air delivery conduit; an air-impermeable covering provided on the reinforcement structure along the length of the air delivery conduit, the air-impermeable covering allowing air flow to be conveyed in use through an enclosed air path formed by the covering, the air-impermeable covering including a fabric layer and a sealing layer laminated to the fabric layer; The covering covers the reinforcement structure, and the fabric layer includes a first edge and a second edge, the first edge and the second edge extending along the air delivery conduit, an outer side and an inner side, respectively, and the inner side of the fabric layer includes: a first portion on a first side of the first edge adjacent the first edge; and a second region adjacent the first edge, the second region being on a second side of the first edge opposite the first side; A portion of the sealing layer extends beyond a first edge of the fabric layer to form a sealing flap that is sealed to another portion of the sealing layer to prevent leakage flow between a first portion inside the fabric layer and a second portion inside the fabric layer.

[0118] In examples: (a) the sealing flap is sealed to both the outside of the fabric layer adjacent the first edge of the fabric layer and the inside of the sealing layer; and / or (b) the sealing flap is sealed to the inside of the sealing layer on the second side of the first edge of the fabric layer.

[0119] In examples: (a) the sealing layer is bonded to the reinforcing structure; (b) the sealing layer comprises a thermoplastic material; (c) the sealing layer comprises a thermoplastic polyurethane; (d) the sealing layer is heat-bonded to the reinforcing structure; (e) the sealing layer is bonded to the reinforcing structure; (f) the air delivery conduit comprises an outer strip bonded to the outside of the air-impermeable covering across and along the second edge of the covering; (g) the outer strip comprises a flexible tape; and / or (h) the outer strip comprises a woven material.

[0120] In examples: (a) the sealing layer comprises a thermoplastic material; (b) the sealing layer comprises a thermoplastic polyurethane; (c) the fabric layer and the sealing layer are bonded together by a dot adhesive lamination; (d) the inside of the covering material near the second edge is bonded to the outside of the covering material near the first edge, and the second edge is spaced from the first edge so that the covering material overlaps the second edge; and / or (e) the second edge of the covering material includes a sawtooth profile configured to resist peeling of the second edge of the covering material from the outside of the covering material.

[0121] In examples: (a) the reinforcing structure includes a plurality of support structures spaced apart along the length of the air delivery conduit; (b) each support structure takes the form of a ring member; (c) the reinforcing structure includes one or more helical members; (d) the air delivery conduit includes a first end configured to connect to tubing connected to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface; and / or (e) the air delivery conduit includes a first end configured to connect to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface.

[0122] In the example: the sealing flap is sealed to both the outside of the fabric layer adjacent the first edge of the outer sheet and the inside of the sealing layer.

[0123] In the example: the sealing flap is sealed to the inside of the sealing layer on the second side of the first edge of the outer sheet.

[0124] In the example: the sealing layer is bonded to the reinforcing structure.

[0125] In an example: the air delivery conduit comprises an outer strip joined to the outside of the fabric sheet across and along the second edge of the fabric sheet.

[0126] In an example: the sealing layer comprises a thermoplastic material.

[0127] In an example: the inside of the covering material adjacent the second edge is joined to the outside of the covering material adjacent the first edge, and the second edge is spaced apart from the first edge so that the covering material overlaps the second edge.

[0128] In an example: the second edge of the covering material includes a serrated profile configured to resist peeling of the second edge of the covering material from the exterior of the covering material.

[0129] In an example: the reinforcing structure includes a plurality of support structures spaced along the length of the air delivery conduit.

[0130] In an example: the air delivery conduit includes a first end configured to connect to tubing connected to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface.

[0131] Another aspect of the present technology includes an air delivery conduit configured to convey a flow of air under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient, the air delivery conduit including: a flexible reinforcing structure along the length of the air delivery conduit; Sealing strips added to the reinforcement structure; an air-impermeable textile covering over the reinforcement structure and the sealing strip, the covering allowing air flow to be conveyed in use through an enclosed air path formed by the covering, the covering having first and second edges each extending along the air delivery conduit, the first and second edges meeting or overlapping to form a seam; The sealing strip seals the entire inside of the seam, thereby preventing air leakage through the seam.

[0132] In examples: (a) the covering is bonded to itself at a location near the seam; (b) the covering is bonded to the reinforcing structure; (c) the covering is bonded to the sealing strip; (d) the sealing strip comprises a thermoplastic material; (e) the air delivery conduit further comprises an outer strip bonded to the exterior of the covering along a second edge of the covering; (f) the first edge of the covering and / or the second edge of the covering are serrated; (g) the covering has a laminate structure; (h) the covering has a thickness of 100 psi; The bar material includes an air-impermeable inner layer and an outer fabric layer; (i) the air-impermeable inner layer includes a thermoplastic material; (j) the inner portion of the seam is aligned along the centerline of the sealing strip; (k) the reinforcing structure includes a plurality of support structures spaced apart along the length of the air delivery conduit; and / or (l) the air delivery conduit includes a first end configured to connect to tubing connected to an outlet of the respiratory pressure therapy device and a second end configured to connect to a patient interface.

[0133] In the example: the covering material itself is joined at a location adjacent to the seam.

[0134] In the example: the covering material is bonded to the reinforcing structure.

[0135] In the example: the covering material is bonded to the sealing strip.

[0136] In an example: the covering material comprises a textile material and the sealing strip comprises a thermoplastic material.

[0137] In an example: the conduit further comprises an outer strip joined to the exterior of the covering along the second edge of the covering.

[0138] In an example: the first edge of the covering and / or the second edge of the covering is serrated.

[0139] In the example: the covering material has a laminate structure.

[0140] In an example: the covering comprises an air impermeable inner layer and an outer textile layer.

[0141] In an example: the air impermeable inner layer comprises a thermoplastic material.

[0142] In the example: the inner side of the seam is aligned along the centerline of the sealing strip.

[0143] In an example: the reinforcing structure includes a plurality of support structures spaced along the length of the air delivery conduit.

[0144] In an example: the air delivery conduit includes a first end configured to connect to tubing connected to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface.

[0145] Another aspect of the present technology includes an air delivery conduit configured to convey a flow of air under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient, the air delivery conduit including: a flexible reinforcing structure including a plurality of support structures spaced apart along the length of the air delivery conduit; an air-impermeable covering disposed on the support structure along the length of the air delivery conduit, the air-impermeable covering allowing air flow to be conveyed in use through an enclosed air path formed by the covering; Each support structure includes an outer surface, an inner surface opposite the outer surface, and a pair of intermediate surfaces connecting the outer and inner surfaces, and each support structure includes a cross-section having outer circular corners connecting the outer and intermediate surfaces.

[0146] In examples: (a) the cross section of each support structure includes an inner circular corner connecting the inner surface and the intermediate surface; (b) the outer circular corner of each support structure has a larger radius than the inner circular corner; (c) the inner surface of each support structure is convex; (d) the support structure is substantially rigid; (e) the support structure is formed from a plastic material; and / or (f) the support structure is formed from one of polycarbonate, nylon, polycarbonate ABS, and nylon-polyurethane.

[0147] In examples: (a) each support structure is formed as a ring member; (b) each support structure includes a circular outer contour and a non-circular inner contour; (c) each support structure includes a pair of thickened portions on opposite sides of the support structure; (d) each support structure includes an oval inner contour; (e) each support structure includes an oval outer contour; (f) each support structure includes an oval inner contour; (g) the inner contour of each support structure includes a pair of straight sides on opposite sides of the support structure; and / or (h) the pair of straight sides are opposed along the major axis of the oval inner contour.

[0148] In examples: (a) the support structures are spaced apart by a distance of 1 mm to 9 mm; (b) the support structures are spaced apart by a distance of 2 mm to 6 mm; (c) the support structures are spaced apart by a distance of 2 mm to 3 mm; (d) the support structures are spaced apart by a distance of less than 6 mm; and / or (e) the support structures are spaced apart by a distance of less than 3 mm.

[0149] In examples: (a) the air impermeable covering includes an outer surface formed from a woven material; (b) the air delivery conduit includes a first end configured to connect to tubing connected to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface; and / or (c) the air delivery conduit includes a first end configured to connect to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface.

[0150] In the example: the cross section of each support structure includes an inner circular corner connecting the inner surface and the intermediate surface.

[0151] In the example: the radius of the outer circular corner of each support structure is larger than the radius of the inner circular corner.

[0152] In the example: the inner surface of each support structure is convex.

[0153] In an example: the support structure is substantially rigid.

[0154] In examples: the support structure(s) include a pair of thickened portions on opposite sides of the support structure.

[0155] In the example: each support structure is formed as a ring member.

[0156] In an example: each ring member includes an oval outer profile.

[0157] In an example: each ring member includes a circular outer contour and a non-circular inner contour.

[0158] In the example: each ring member has an oval inner outer shape.

[0159] In an example: the inner contour of each ring member includes a pair of straight sides on opposite sides of the ring member.

[0160] In the example: a pair of straight sides are opposed along the major axis of the oval inner profile.

[0161] Another aspect of the present technology includes an air delivery conduit configured to convey a flow of air under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient, the air delivery conduit including: a flexible reinforcing structure including a plurality of support structures spaced apart along the length of the air delivery conduit; an air-impermeable covering disposed on the support structure along the length of the air delivery conduit, the air-impermeable covering allowing air flow to be conveyed in use through an enclosed air path formed by the covering; Each support structure includes a pair of thickened portions on opposite sides of the support structure.

[0162] In examples: (a) each support structure includes a circular outer contour and a non-circular inner contour; (b) each support structure includes an oval inner contour; (c) a pair of thickened portions are opposed along the minor axis of the oval inner contour; (d) each support structure includes an oval outer contour; (e) each support structure includes an oval inner contour; (f) the thickened portions are opposed along the major axis of the oval inner contour; and / or (g) each support structure includes an outer surface, an inner surface opposite the outer surface, and a pair of intermediate surfaces connecting the outer and inner surfaces, each support structure thickened portion corresponding to a wide portion of the intermediate surface of the support structure.

[0163] In an example: (a) each support structure includes an outer surface, an inner surface, a pair of intermediate surfaces, and a cross section including an outer circular corner connecting the outer surface and the face; (b) the cross section of each support structure includes an inner circular corner connecting the inner surface and the face; (c) the radius of the outer circular corner of each support structure is greater than the radius of the inner circular corner; and / or (d) each support structure includes a convex inner surface.

[0164] In examples: (a) the support structures are spaced apart by a distance of 1 mm to 10 mm; (b) the support structures are spaced apart by a distance of 2 mm to 6 mm; (c) the support structures are spaced apart by a distance of 2 mm to 3 mm; (d) the support structures are spaced apart by a distance of less than 6 mm; and / or (e) the support structures are spaced apart by a distance of less than 3 mm.

[0165] In examples: (a) the air impermeable covering comprises a woven material; (b) the air impermeable covering comprises an outer surface formed from the woven material; (c) the air delivery conduit comprises a first end configured to connect to tubing connected to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface; and / or (d) the air delivery conduit comprises a first end configured to connect to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface.

[0166] In an example: each support structure includes a circular outer contour and a non-circular inner contour.

[0167] In the example: each support structure includes an oval inner contour.

[0168] In the example: a pair of thickened sections are opposed along the minor axis of the oval inner profile.

[0169] In the example: each support structure includes an oval outer contour.

[0170] In the example: each support structure includes an oval inner contour.

[0171] In the example: the thickened portions are opposed along the major axis of the oval inner profile.

[0172] In an example, each support structure includes an outer surface, an inner surface opposite the outer surface, and a pair of intermediate surfaces connecting the outer surface and the inner surface, and the thickened portion of each support structure corresponds to the widened portion of the intermediate surface of the support structure.

[0173] In the example: each support structure includes a cross section including an outer circular corner connecting an outer surface and an intermediate surface.

[0174] In the example: the cross section of each support structure includes an inner circular corner connecting the inner surface and the intermediate surface.

[0175] In the example: the radius of the outer circular corner of each support structure is larger than the radius of the inner circular corner.

[0176] In an example: each support structure includes a convex inner surface.

[0177] Another aspect of the present technology includes an air delivery conduit configured to convey a flow of air under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient, the air delivery conduit including: a flexible reinforcing structure along the length of the air delivery conduit; a covering attached to the reinforcement structure along the length of the air delivery conduit, the covering comprising a woven material; a sealing layer that forms a sealed air path through which air flow can be conveyed in use; The reinforcing structure is provided between the covering material and the sealing layer.

[0178] In examples: (a) the reinforcing structure includes a plurality of support structures spaced apart along the length of the air delivery conduit; (b) the support structures each take the form of a ring member; (c) the reinforcing structure includes one or more helical members; (d) the sealing layer is formed from a polymeric material; (e) the sealing layer is formed from a thermoplastic material; (f) the thermoplastic material includes a thermoplastic polyurethane; (g) the sealing layer includes a thickness of less than 0.5 mm; (h) the sealing layer includes a thickness of less than 0.2 mm; (i) the sealing layer includes a thickness of less than 0.15 mm; (j) the sealing layer includes a thickness of less than 0.1 mm; (k) the woven material includes a knitted structure; (l) the woven material includes a woven structure; (m) the woven material includes (n) the sealing layer is heat-bonded to the reinforcing structure and / or the covering; (o) the sealing layer is bonded to the reinforcing structure and / or the covering; (p) the air delivery conduit has a first end configured to connect to tubing connected to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface, and / or (q) the air delivery conduit has a first end configured to connect to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface.

[0179] In examples: (a) the sealing layer comprises a single film layer; (b) the sealing layer comprises an inner film layer and an outer film layer; (c) the inner film layer is configured to be hydrolytically resistant; (d) the inner film layer is antibacterial; (e) the inner film layer comprises an ether-type TPU; and / or (f) the outer film layer has a lower softening temperature than the inner film layer.

[0180] In an example: the reinforcing structure includes a plurality of support structures spaced along the length of the air delivery conduit.

[0181] In the example: the support structures each take the form of a ring member.

[0182] In the example: the sealing layer is formed from a thermoplastic material.

[0183] In examples: textile materials include knitted structures.

[0184] In the example: the sealing layer is heat bonded to the reinforcing structure.

[0185] In the example: the sealing layer is heat bonded to the covering material.

[0186] In an example: the inner film layer is configured to be hydrolytically resistant.

[0187] In an example: the inner film layer is antimicrobial.

[0188] In the example: the inner film layer comprises an ether-type TPU.

[0189] In the example: the softening temperature of the outer film layer is lower than that of the inner film layer.

[0190] Another aspect of the present technology includes a method of manufacturing an air delivery conduit configured to carry a flow of air under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient, the method including: applying a covering material to the exterior of the elongated flexible reinforcing structure; inserting a sealing layer into the interior of the reinforcement structure, the sealing layer including an elongated cylindrical shape upon insertion into the interior of the reinforcement structure; and Adhering a sealing layer to the covering material, the sealing forming an enclosed air path that allows air flow to be conveyed during use.

[0191] In examples: (a) the method includes supporting a reinforcement structure on a mandrel and sliding a cover material over the reinforcement structure; (b) the method includes supporting a reinforcement structure on a mandrel and covering the reinforcement structure with the cover material; and / or (c) the method includes holding the cover material in an open state and inserting the reinforcement structure into the cover material.

[0192] In examples: (a) the method includes preheating the covering material; (b) the method includes preheating the covering material by blowing hot air therethrough and then inserting a sealing layer; (c) the method includes blowing hot air from a mandrel inserted into the covering material; (d) the method includes blowing hot air from outside the covering material through the covering material; (e) the method includes supporting the sealing layer on a mandrel and inserting the mandrel and sealing layer into the interior of the reinforcement structure; (f) the method includes blowing hot air into the interior of the sealing layer to expand and bond the sealing layer to the covering material; (g) the method includes thermally bonding the sealing layer to the covering material; (h) the method includes adhering the sealing layer to the covering material; (i) the mandrel has a low-friction surface; and / or (j) the method includes supporting the sealing layer on a balloon on the mandrel and inflating the balloon with hot air to expand the sealing layer and bond it to the covering material.

[0193] In further examples: (a) the covering material comprises a woven material; (b) the reinforcing structure comprises a plurality of support structures spaced apart along the length of the air delivery conduit; (c) the reinforcing structure comprises one or more spiral members; (d) the sealing layer is formed from a polymeric material; (e) the sealing layer is formed from a thermoplastic material; (f) the thermoplastic material comprises a thermoplastic polyurethane; (g) the sealing layer comprises a thickness of less than 0.5 mm; (h) the sealing layer comprises a thickness of less than 0.2 mm; (i) the sealing layer comprises a thickness of less than 0.15 mm; (j) the sealing layer comprises a thickness of less than 0.1 mm; (k) the woven material comprises a knitted structure; (l) the woven material comprises a woven structure; and / or (m) the woven material comprises a non-woven structure; and / or (n) the support structures each take the shape of a ring member.

[0194] In further examples: (a) the sealing layer comprises a single film layer; (b) the sealing layer comprises an inner film layer and an outer film layer; (c) the inner film layer is configured to be hydrolytically resistant; (d) the inner film layer is antibacterial; (e) the inner film layer comprises an ether-type TPU; and / or (f) the outer film layer has a lower softening temperature than the inner film layer.

[0195] In an example: the covering comprises a first layer on a first side of the covering and a second layer on a second side of the covering, the first layer comprising an air impermeable sealing layer.

[0196] In an example: the method includes forming a covering material into an elongated cylindrical shape from a sheet by joining opposing edges of the sheet, the sheet being a laminate formed by a first layer and a second layer.

[0197] In an example: the method includes forming the covering into an elongated cylindrical shape by forming the second layer into an elongated cylindrical shape followed by applying the first layer over the second layer.

[0198] In an example: the method includes weaving a second layer. In an example: the method includes inverting the covering material by inward rotation of the covering material to move it onto a mandrel to a central axis of the covering material.

[0199] In an example: the method includes supporting a reinforcement structure on a mandrel by folding the mandrel, mounting the reinforcement structure on the mandrel, and expanding the mandrel.

[0200] In an example: the method includes inserting the mandrel and reinforcing structure into the covering material and then folding the mandrel to release the reinforcing structure.

[0201] In an example: the method includes adhering a reinforcing structure to a covering material.

[0202] In an example: the method includes bonding or welding the reinforcing structure to the covering material by one of thermal bonding or ultrasonic welding.

[0203] Another aspect of the present technology includes a method of manufacturing an air delivery conduit configured to carry a flow of air under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient, the method including: forming a covering for the air delivery conduit, the covering including an elongated cylindrical shape and including a first side providing an outer surface of the covering and a second side providing an inner surface of the covering; supporting an elongated flexible reinforcing structure on a mandrel; inserting the mandrel and reinforcing structure into the interior of the covering while the covering is inverted, such that an inner surface of the covering is accessible from a first side and an outer surface of the covering is accessible from a second side; The mandrel is removed from the covering, leaving the reinforcing structure within the covering.

[0204] In examples: (a) the covering material includes a first layer on a first side of the covering material and a second layer on a second side of the covering material, the first layer including an air-impermeable sealing layer; (b) the method includes forming the covering material from a sheet into an elongated cylindrical shape by joining opposing edges of the sheet, the sheet being a laminate formed by the first layer and the second layer; (c) the method includes forming the covering material into an elongated cylindrical shape by forming the second layer into an elongated cylindrical shape followed by disposing the first layer on the exterior of the second layer; (d) the method includes weaving or knitting the second layer; (e) the method includes weaving or knitting the second layer; (f) the method includes supporting a reinforcing structure on the mandrel by folding the mandrel, attaching the reinforcing structure onto the mandrel, and expanding the mandrel; (g) the method includes inserting the mandrel and reinforcing structure into the covering material, and then folding the mandrel to release the reinforcing structure; (h) the method includes bonding the reinforcing structure to the covering material; and / or (i) the method includes bonding or welding the reinforcing structure to the covering material by one of thermal bonding or ultrasonic welding.

[0205] In further examples: (a) the covering material comprises a woven material; (b) the woven material comprises a knitted structure; (c) the woven material comprises a woven structure; (d) the woven material comprises a non-woven structure; (e) the reinforcing structure comprises a plurality of support structures spaced apart along the length of the air delivery conduit; (f) the reinforcing structure comprises one or more helical members; (g) the first layer is formed from a polymeric material; (h) the first layer is formed from a thermoplastic material; (i) the thermoplastic material comprises a thermoplastic polyurethane; (j) the first layer comprises a thickness of less than 0.5 mm; (k) the first layer comprises a thickness of less than 0.2 mm; (l) the first layer comprises a thickness of less than 0.15 mm; (m) the first layer comprises a thickness of less than 0.1 mm; and / or (n) the support structures each take the shape of a ring member.

[0206] In a further example: (a) the covering material comprises a woven material; and / or (b) the method comprises inserting an air-impermeable sealing layer into an interior of the reinforcement structure, the sealing layer comprising an elongated cylindrical shape upon insertion into the interior of the reinforcement structure, and adhering the sealing layer to the covering material.

[0207] In an example: the method includes supporting a reinforcement structure on a mandrel and sliding a covering material over the reinforcement structure.

[0208] In an example: the method includes supporting a reinforcement structure on a mandrel and covering the reinforcement structure with a covering material.

[0209] In an example: the method includes holding the covering in an open state and inserting a reinforcing structure into the covering.

[0210] In an example: the method includes preheating the covering material.

[0211] In the example: the method involves preheating the covering material with a hot air jet and then inserting the sealing layer.

[0212] In an example: the method includes blowing hot air through a mandrel inserted into the covering material.

[0213] In an example: the method includes supporting a sealing layer on a mandrel and inserting the mandrel and sealing layer inside a reinforcement structure.

[0214] In an example: the method includes blowing hot air into the interior of the sealing layer to expand and bond the sealing layer to the covering material.

[0215] In the example: the mandrel is provided with a low friction surface.

[0216] In an example: the method includes supporting a sealing layer on a balloon on a mandrel and inflating the balloon with hot air to expand the sealing layer and bond the sealing layer to the covering. Another aspect of the present technology includes a method of manufacturing an air delivery conduit configured to carry a flow of air under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to the patient. The method includes:

[0217] supporting a stretchable, air-impermeable covering for the air delivery conduit, the covering including an elongated cylindrical shape including an exterior and an interior; Expanding the covering material; inserting an elongated flexible reinforcing structure into the covering material; Releasing the covering material to allow the covering material to contact the reinforcing structure.

[0218] In examples: (a) the method includes inserting an elongated, flexible reinforcing structure into an interior of a covering material while supporting the reinforcing structure on a mandrel, and removing the mandrel from the interior of the covering material, leaving the reinforcing structure within the covering material; (b) the method includes expanding the covering material by applying an air pressure to the interior of the covering material that is higher than the air pressure to the exterior of the covering material; (c) the method includes releasing the covering material by removing the higher air pressure; (d) the method includes expanding the covering material by applying a vacuum to the exterior of the covering material; (e) the method includes releasing the covering material by releasing the vacuum; (f) the method includes supporting the covering material at an end of the covering material with a vacuum fixture; and / or (g) the method includes generating a vacuum between the exterior of the covering material and a vacuum fixture, the vacuum fixture being wider than the covering material, thereby allowing the covering material to expand.

[0219] In examples: (a) the elongated reinforcing structure includes a plurality of spaced apart support structures, each of which is wider than the covering material when the covering material is in contact; (b) after the mandrel is removed from the interior of the covering material, the air delivery conduit includes a groove in the covering material between adjacent pairs of support structures; (c) the mandrel includes a plurality of teeth, the plurality of teeth configured to slide the support structures along the mandrel in a first direction and to prevent the support structures from sliding along the mandrel in a second direction opposite the first direction; (d) each tooth includes a first wall portion and a second wall portion, the first wall portion tapered with respect to a central axis of the mandrel and the second wall portion perpendicular to the central axis of the mandrel, the first wall portion configured to slide the support structures on each tooth in the first direction and the second wall portion configured to prevent the support structures from sliding along the mandrel in the second direction; (e) the mandrel includes a plurality of teeth configured to slide the support structures on the mandrel in a first direction and to prevent the support structures from sliding along the mandrel in a second direction; (f) each set of teeth includes a plurality of teeth arranged concentrically around the central axis of the mandrel at each point along the central axis; (g) the teeth are biased to an outwardly protruding position relative to the central axis of the mandrel and can be depressed inwardly relative to the central axis of the mandrel, thereby allowing the support structure to slide in a first direction on the teeth; (h) the teeth are spring-biased to an outwardly protruding position; (i) the method includes at least partially adhering the covering material to the reinforcing structure before removing the mandrel from an interior of the covering material; the method includes adhering the covering material to the reinforcing structure after removing the mandrel from an interior of the covering material; (j) the method includes one of thermally adhering, ultrasonically welding, and adhering the covering material to the reinforcing structure; and / or (k) each support structure is in the form of a ring member.

[0220] In further examples: (a) the covering material comprises a woven material; (b) the woven material comprises a knitted structure; (c) the woven material comprises a woven structure; and / or (d) the woven material comprises a non-woven structure.

[0221] In further examples: (a) the covering material includes a first layer inside the covering material and a second layer outside the covering material, the first layer including an air-impermeable sealing layer; (b) the second layer includes a woven material; (c) the method includes weaving the woven material; (d) the method includes weaving the woven material; (e) the woven material includes a non-woven structure; (f) the method includes forming the covering material into an elongated cylindrical shape from a sheet by joining opposing edges of the sheet, the sheet being a laminate formed by the first layer and the second layer; and / or (g) the method includes forming the covering material into an elongated cylindrical shape (by disposing the first layer inside the second layer after forming the second layer into an elongated cylindrical shape).

[0222] In further examples: (a) the first layer is formed from a polymeric material; (b) the first layer is formed from a thermoplastic material; (c) the thermoplastic material comprises a thermoplastic polyurethane; (d) the first layer comprises a thickness of less than 0.5 mm; (e) the first layer comprises a thickness of less than 0.2 mm; (f) the first layer comprises a thickness of less than 0.15 mm; and / or (g) the first layer comprises a thickness of less than 0.1 mm.

[0223] In an example: the method includes expanding the covering by applying a higher air pressure to the interior of the covering than to the exterior of the covering.

[0224] In an example: the method includes releasing the covering by removing the higher air pressure.

[0225] In an example: the method includes expanding the covering by applying a vacuum to the exterior of the covering.

[0226] In an example: the method includes releasing the covering by releasing the vacuum.

[0227] In an example: the method includes supporting the covering material at an edge of the covering material with a vacuum fixture.

[0228] In an example: the method includes creating a vacuum between an exterior of the covering material and a vacuum fixture, the vacuum fixture being wider than the covering material to allow expansion of the covering material.

[0229] In an example, the method includes inserting an elongated flexible reinforcement structure into the interior of the covering material while supporting the reinforcement structure on a mandrel, and removing the mandrel from the interior of the covering material, leaving the reinforcement structure within the covering material.

[0230] In an example: the elongate reinforcing structure includes a plurality of spaced apart ring members, each of which is wider than the covering material when the covering material is in contact therewith.

[0231] In an example, after removal of the mandrel from the interior of the covering, the air delivery conduit comprises a groove in the covering between adjacent pairs of ring members.

[0232] In an example: the mandrel includes a plurality of teeth configured to allow the ring member to slide along the mandrel in a first direction and to prevent the ring member from sliding along the mandrel in a second direction opposite the first direction.

[0233] In an example: each tooth includes a first wall portion and a second wall portion, the first wall portion tapered to a central axis of the mandrel and the second wall portion perpendicular to the central axis of the mandrel, the first wall portion configured to allow a ring member to slide in a first direction on each tooth, and the second wall portion configured to prevent the ring member from sliding in a second direction along the mandrel.

[0234] In an example: the mandrel includes a plurality of sets of teeth spaced along the mandrel, each set of teeth configured to prevent each ring member from sliding in the second direction along the mandrel.

[0235] In an example: each set of teeth includes a plurality of teeth arranged concentrically around the central axis of the mandrel at each point along the central axis.

[0236] In an example: the teeth are biased to a position that protrudes outward relative to the central axis of the mandrel and can be depressed inward relative to the central axis of the mandrel, causing a ring member to slide in a first direction over the teeth.

[0237] In the example: the teeth are spring biased to an outwardly protruding position.

[0238] In an example: the method includes at least partially adhering the covering to the reinforcement structure prior to removal of the mandrel from within the covering.

[0239] In an example: the method includes adhering the covering to the reinforcement structure after removing the mandrel from the interior of the covering.

[0240] In an example: the method includes one of thermally bonding, ultrasonically welding and gluing the covering material to the reinforcement structure.

[0241] Another aspect of the present technology includes an air delivery conduit configured to convey a flow of air under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient, the air delivery conduit including: a flexible reinforcing structure including a plurality of support structures spaced apart along the length of the air delivery conduit; an air-impermeable covering disposed on the support structure along the length of the air delivery conduit, the air-impermeable covering allowing air flow to be conveyed in use through an enclosed air path formed by the covering; The covering includes an outer surface formed from a woven material.

[0242] In examples: (a) the covering material is in the form of a laminate and includes an outer layer including a woven material bonded to an air-impermeable inner layer; (b) the air-impermeable inner layer is formed from a polymer; (c) the air-impermeable inner layer is formed from a thermoplastic material; (d) the thermoplastic material includes a thermoplastic polyurethane; (e) the air-impermeable inner layer includes a thickness of less than 0.5 mm; (f) the air-impermeable inner layer includes a thickness of less than 0.15 mm; (g) the woven material includes a knitted structure; (h) the woven material includes a woven structure; (i) the woven material includes a non-woven structure; and / or (j) the covering material includes a weight of less than 250 GSM; and the covering material includes a weight of less than 180 GSM.

[0243] Another aspect of the present technology includes an air delivery conduit configured to convey a flow of air under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient, the air delivery conduit including: A textile layer formed from a woven fabric, the textile layer comprising: at least one first region formed from a first network of fibers of the woven fabric, the first region having a first stiffness; at least one second region formed from a second network of fibers of the woven fabric, the second region being effected by a curing process to have a second stiffness greater than the first stiffness; The air delivery conduit forms a sealed air path through which air flow can be conveyed during use.

[0244] In examples: (a) the fabric layer includes an active material applied to a second region, and the active material causes the second region to harden after a curing process; (b) the first fiber network includes the first material and the second fiber network includes the active material; and / or (c) the second fiber network includes both the first material and the active material.

[0245] In further examples: (a) the curing process includes a heat treatment; (b) the active material includes at least one of a thermosetting material and a thermoplastic material; (c) the second portion of the textile layer includes a cured portion; (d) the second fiber network includes a plurality of cured thermosetting fibers; (e) the second portion of the textile layer includes a fused portion; (f) the second fiber network includes a plurality of fibers at least partially fused together; and / or (g) the second fiber network includes fibers at least partially fused relative to one or more surrounding fibers.

[0246] In examples: (a) the curing process includes a light-activated treatment; (b) the active material includes a photoactive material that cures a second portion of the textile layer after application of visible or non-visible light to the second portion; (c) the second portion of the textile layer includes a cured portion; and (d) the second fiber network includes a plurality of fibers formed from the photoactive material.

[0247] In further examples: (a) the curing process comprises a pressure-activated process; (b) the active material comprises a pressure-activated material that cures a second region of the fabric layer after application of pressure to the second region; (c) the active material comprises an adhesive that cures the second fiber network after application of pressure to the second region; (d) the active material comprises a microencapsulated adhesive; and (e) the second fiber network comprises a plurality of adhesive fibers, each of which is bonded to surrounding fibers by application of pressure to the second region.

[0248] In further examples: (a) the curing process includes a chemically activated treatment; (b) the activated material includes one or more materials that chemically react after application to the second portion to cure the second portion of the textile layer; (c) the activated material includes a crosslinking agent; and (d) the activated material includes a cured material.

[0249] In further examples: (a) the textile layer is formed by weaving; (b) the textile layer is formed by circular weaving; (c) the textile layer is formed by weft knitting; (d) the textile layer comprises a woven fabric; and / or (e) the textile layer comprises a nonwoven fabric.

[0250] In further examples: (a) each of the at least one second region comprises a substantially rigid region; (b) the woven fabric comprises a plurality of first regions; (c) the woven fabric comprises a plurality of second regions; (d) the woven fabric comprises a plurality of first regions and a plurality of second regions arranged in an alternating pattern along the air delivery conduit; (e) at least one second region comprises a plurality of ring portions arranged at intervals along the air delivery conduit; (f) at least one second region comprises at least one spiral portion extending spirally along the air delivery conduit; and / or (g) at least one second region comprises a plurality of spiral portions each extending spirally along the air delivery conduit.

[0251] In further examples: (a) the fabric layer is air impermeable and forms a sealed air path; (b) the air delivery conduit includes a sealing layer within the fabric layer, the sealing layer forming a sealed air path; (c) the fabric layer is bonded to the sealing layer; (d) the sealing layer comprises a thermoplastic material; (e) the sealing layer comprises a thermoplastic polyurethane; (f) the sealing layer is heat-bonded to the fabric layer; (g) the sealing layer is bonded to the outer layer; (h) the sealing layer comprises a thickness of less than 0.5 mm; (i) the sealing layer comprises a thickness of less than 0.2 mm; and / or (j) the sealing layer comprises a thickness of less than 0.15 mm.

[0252] In a further example: (a) the fabric layer comprises a circular cross-section; and / or (b) the fabric layer comprises a D-shaped cross-section.

[0253] In further examples: (a) the sealing layer comprises a single film layer; (b) the sealing layer comprises an inner film layer and an outer film layer; (c) the inner film layer is configured to be hydrolytically resistant; (d) the inner film layer is antibacterial; (e) the inner film layer comprises an ether-type TPU; and / or (f) the outer film layer has a lower softening temperature than the inner film layer.

[0254] In examples: (a) the air delivery conduit includes a first end configured to connect to tubing connected to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface; and (b) the air delivery conduit includes a first end configured to connect to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface.

[0255] In an example: the textile layer comprises an active material applied to the second region, the active material causing the second region to harden after the curing process.

[0256] In an example: a first fiber web includes a first material and a second fiber web includes an active material.

[0257] In an example: the second fiber network includes the first material in addition to the active material.

[0258] In an example: the hardening process includes a heat treatment.

[0259] In an example: the active material comprises at least one of a thermoset material and a thermoplastic material.

[0260] In an example: the second portion of the fabric layer comprises a stiffening portion.

[0261] In an example: the second fiber network includes a plurality of cured thermoset fibers.

[0262] In an example: the second fiber network comprises a dissolved portion.

[0263] In an example: the second fiber network comprises a plurality of fibers at least partially fused together.

[0264] In an example: the second fiber network comprises fibers that are at least partially dissolved relative to one or more surrounding fibers.

[0265] In an example: the curing process includes a light-activated treatment.

[0266] In an example: the active material comprises a photoactive material that hardens the second portion of the textile layer after application of visible or non-visible light to the second portion.

[0267] In the example: the fabric layer comprises a stiffening portion.

[0268] In an example: the second fiber network includes a plurality of fibers formed from a photoactive material.

[0269] In an example: the curing process includes a pressure activated treatment.

[0270] In an example: the active material comprises a pressure active material that stiffens the second portion of the fabric layer after application of pressure to the second portion.

[0271] In an example: the active material includes an adhesive that hardens the second fiber network after application of pressure to the second region.

[0272] In an example: the active material comprises a microencapsulated adhesive.

[0273] In an example: the second fiber network includes a plurality of bonded fibers each bonded to surrounding fibers by application of pressure to the second region.

[0274] In an example: the curing process includes a chemically activated treatment.

[0275] In an example: the active material comprises one or more materials that chemically react after application to the second portion to harden the second portion of the textile layer.

[0276] In an example: the active material comprises a crosslinker.

[0277] In an example: the active material comprises a hardened material.

[0278] In the example: the textile layer is formed by weaving or knitting.

[0279] In the example: the fabric layer is formed by circular weaving.

[0280] In the example: the fabric layer is formed by weft knitting.

[0281] In an example: each of the at least one second region comprises a substantially rigid region.

[0282] In an example: the textile layer includes a plurality of first regions.

[0283] In an example: the textile layer includes a plurality of second regions.

[0284] In an example: the fabric layer includes a plurality of first regions and a plurality of second regions arranged in an alternating fashion along the air delivery conduit.

[0285] In examples: the at least one second region comprises a plurality of rings spaced apart along the air delivery conduit.

[0286] In examples: the at least one second portion includes at least one spiral portion extending spirally along the air delivery conduit.

[0287] In examples: the at least one second portion includes a plurality of spiral portions each extending helically along the air delivery conduit.

[0288] In the example: the fabric layer is air impermeable and forms a sealed air path.

[0289] In an example: the air delivery conduit includes a sealing layer within a fabric layer, the sealing layer forming a sealed air pathway.

[0290] In the example: the fabric layer comprises a circular cross section.

[0291] In the example: the fabric layer comprises a D-shaped cross section.

[0292] Another aspect of the present technology includes a method of manufacturing an air delivery conduit configured to carry a flow of air under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient, the method including: forming a fabric layer for the air delivery conduit, the fabric layer including at least one first portion formed from a first fiber braid and at least one second portion formed from a second fiber braid; performing a curing process on a second portion of the fabric layer to cause the second portion to have a higher stiffness than the first portion of the fabric layer; The air delivery conduit forms a sealed air path through which air flow can be conveyed during use.

[0293] In examples: (a) the method includes knitting the fabric; (b) the method includes knitting a circular fabric; (c) the method includes flat knitting the fabric; (d) the method includes weaving the fabric; (e) the method includes knitting the fabric into an elongated cylindrical shape; and / or (f) the method includes forming the fabric as an elongated flat strip and then joining the edges of the fabric to form an elongated cylindrical shape.

[0294] In further examples: (a) the method includes applying an active material to a second region of the fabric layer, where the second region is hardened by a curing process due to the active material; (b) the method includes forming a first region with fibers formed from the first material and forming a second region with fibers formed from the active material; (c) the method includes forming the second region with both fibers formed from the first material and fibers formed from the active material; (d) the method includes applying an active material to the second region of the fabric layer after forming the fabric layer; and / or (e) the method includes applying more than one active material to the second region of the fabric layer.

[0295] In further examples, (a) the activated material comprises a heat-processable material; (b) the activated material comprises a lower melting point than the first material; (c) the activated material is more easily curable than the first material; (d) the activated material comprises a thermosetting material; (e) the activated material comprises a thermoplastic material; (f) the activated material comprises a light-activated material that cures the second portion of the textile layer upon application of visible or non-visible light to the second portion; (g) the activated material comprises a pressure-activated material that cures the second portion of the textile layer upon application of pressure to the second portion; (h) the activated material comprises a microencapsulated adhesive; (i) the activated material comprises one or more chemically activated materials configured to cure the second portion of the textile layer by a chemical reaction; and / or (j) the activated material comprises a crosslinker.

[0296] In a further example: (a) performing the hardening process includes heat-treating a second region of the fabric layer; (b) heat-treating the second region includes hardening fibers of the fabric in the second region by heating the second region; (c) heat-treating the second region includes hardening fibers of the fabric in the second region; (d) heat-treating the second region includes at least partially melting fibers of the fabric in the second region; and (e) heat-treating the second region includes softening fibers of the fabric in the second region by heating the second region and melting the softened fibers of the second region. (f) the step of heat-treating the second region includes melting the fibers of the fabric in the second region and cooling the fibers to melt them to the surrounding fibers; (g) the method includes sealing the fabric layer to create a sealed air path; (h) the step of sealing the fabric layer includes inserting a sealing layer into the interior of the fabric layer and adhering the sealing layer to the fabric layer; and / or (i) the method includes heat-treating the second region in the step of adhering the sealing layer to the fabric layer.

[0297] In a further example: (a) performing the curing process includes performing a light activation process to cure a second portion of the textile layer; (b) the method includes applying visible or non-visible light to the second portion of the textile layer to activate a photoactivated material disposed in the second portion, causing the photoactivated material to cure the second portion; and (c) the method includes curing the second portion of the textile layer using visible or non-visible light.

[0298] In a further example: (a) performing the curing process includes applying pressure to a second region of the fabric layer to cure the second region; (b) the method includes applying pressure to the second region to cure the second region with an adhesive; and (c) the method includes applying pressure to the second region to activate the microencapsulated adhesive.

[0299] In a further example: (a) performing the curing process includes curing a second portion of the textile layer by generating a chemical reaction; (b) the method includes providing one or more materials to the second portion of the textile layer to generate a chemical reaction to cure the second portion; and (c) the method includes providing a crosslinking agent to the second portion of the textile layer.

[0300] In further examples: (a) the method includes forming a plurality of first regions and a plurality of second regions during formation of the fabric layer; (b) the method includes forming the plurality of first regions and the plurality of second regions in alternating fashion along the fabric layer; (c) the method includes forming the plurality of second regions as ring portions spaced apart along the fabric layer; and / or (d) the method includes forming a single second region in the form of a spiral portion extending spirally along the air delivery conduit.

[0301] In further examples: (a) the method includes preheating the fabric layer; (b) the method includes sealing the fabric layer to create a sealed air path; (c) the step of sealing the fabric layer includes inserting a sealing layer into the fabric layer and adhering the sealing layer to the fabric layer; (d) the method includes preheating the fabric layer with a blow of hot air before inserting the sealing layer; (e) the method includes blowing hot air from a mandrel inserted into the fabric layer; and (f) the method includes supporting the sealing layer on the mandrel. and inserting the mandrel and sealing layer inside the fabric layer; (g) the method includes blowing hot air into the sealing layer to expand the sealing layer and bond it to the fabric layer; (h) the method includes heat-bonding the sealing layer to the fabric layer; (i) the method includes bonding the sealing layer to the fabric layer; and / or (j) the method includes supporting the sealing layer on a balloon on the mandrel and inflating the balloon with hot air to expand the sealing layer and bond it to the fabric layer.

[0302] In an example: the method includes weaving a fabric.

[0303] In an example: the method includes weaving a circular fabric.

[0304] In an example: the method includes weft knitting a fabric.

[0305] In an example, the method includes applying an active material to a second portion of the fabric layer, the second portion being hardened by a hardening process due to the active material.

[0306] In an example: the method includes forming a first region with fibers formed from a first material and forming a second region with fibers formed from an active material.

[0307] In an example: the method includes forming the second region with both fibers formed from the first material and fibers formed from the active material.

[0308] In an example, the method includes forming the fabric layer and then providing an active material at a second portion of the fabric layer.

[0309] In an example: the method includes providing more than one active material to the second portion of the fabric layer.

[0310] In an example: the active material comprises a heat-processable material.

[0311] In an example: the active material comprises a lower melting point than the first material.

[0312] In an example: the activated material is more easily curable than the first material.

[0313] In an example: the method includes forming the second portion from a thermosetting material.

[0314] In an example: the method includes forming the second portion from a thermoplastic material.

[0315] In an example: the method includes forming the second portion using both a thermoset material and a thermoplastic material.

[0316] In an example: the activated material comprises a light activated material that hardens the second portion of the textile layer upon application of visible or non-visible light to the second portion.

[0317] In an example: the activated material comprises a pressure activated material that stiffens the second portion of the fabric layer upon application of pressure to the second portion.

[0318] In an example: the active material comprises a microencapsulated adhesive.

[0319] In examples: the activated material includes one or more chemically activated materials configured to harden the second portion of the fabric layer through a chemical reaction.

[0320] In an example: the activated material comprises a crosslinker.

[0321] In an example: performing a curing process includes heat treating a second portion of the fabric layer.

[0322] In an example: the step of heat treating the second region includes heating the second region to stiffen fibers of the fabric within the second region.

[0323] In an example: the step of heat treating the second region includes stiffening fibers of the fabric within the second region.

[0324] In an example: the step of heat treating the second region includes at least partially melting fibers of the fabric within the second region.

[0325] In an example, the step of heat treating the second region includes heating the second region to soften the fibers of the fabric in the second region and allowing the softened fibers of the fabric in the second region to cool and fuse to the surrounding fibers.

[0326] In an example: the step of heat treating the second region includes melting fibers of the fabric within the second region and allowing the fibers to cool and fuse to the surrounding fibers.

[0327] In an example: performing a curing process includes performing a light activation process to cure the second portion of the textile layer.

[0328] In an example, the method includes applying visible or non-visible light to a second portion of the textile layer to activate a photoactivatable material disposed in the second portion, causing the photoactivatable material to cure the second portion.

[0329] In an example: the method includes curing the second portion of the textile layer using visible or non-visible light.

[0330] In an example: performing the curing process includes applying pressure to the second portion of the fabric layer to cure the second portion.

[0331] In an example: the method includes applying pressure to the second portion to cure the second portion with the adhesive.

[0332] In an example: the method includes activating the microencapsulated adhesive by application of pressure to the second site.

[0333] In an example: performing a curing process includes curing a second portion of the fabric layer by causing a chemical reaction to occur.

[0334] In an example: the method includes providing one or more materials to a second portion of the fabric layer to cause a chemical reaction to occur, thereby hardening the second portion.

[0335] In an example, the method includes providing a cross-linking agent to a second portion of the textile layer.

[0336] In an example: the method includes forming a plurality of first regions and a plurality of second regions during formation of the fabric layer.

[0337] In an example: the method includes forming a plurality of first regions and a plurality of second regions in alternating order along the fabric layer.

[0338] In an example, the method includes forming a plurality of second regions as spaced apart rings along the fabric layer.

[0339] In examples: the method includes forming a single second portion in the form of a spiral extending helically along the air delivery conduit;

[0340] In an example: the method includes sealing the fabric layers to create a sealed air path.

[0341] In an example: the step of sealing the textile layer includes inserting a sealing layer inside the textile layer and adhering the sealing layer to the textile layer.

[0342] In an example: the method includes heat treating the textile layer in the step of adhering the sealing layer to the textile layer.

[0343] In an example: the method includes supporting a sealing layer on a mandrel and inserting the mandrel and sealing layer inside the fabric layer.

[0344] In an example: the method includes blowing hot air into the sealing layer to expand it and bond it to the fabric layer.

[0345] In an example: the method includes heat bonding a sealing layer to a textile layer.

[0346] In an example: the method includes adhering a sealing layer to a textile layer.

[0347] In an example: the method includes supporting a sealing layer on a balloon on a mandrel and inflating the balloon with hot air to expand the sealing layer and bond the sealing layer to the fabric layer.

[0348] Another aspect of the present technology includes a patient interface assembly including a patient interface configured for sealing engagement with a patient's face in use, and an air delivery conduit as described in any one of the aspects or examples above, wherein the air delivery conduit is connectable to the patient interface to deliver pressurized breathing gas to the patient interface.

[0349] Another aspect of the present technology includes a respiratory treatment system configured to deliver pressurized respiratory gas to a patient's airway, the system including a respiratory treatment device configured to pressurize a flow of respiratory gas and an air delivery conduit according to any one of the aspects or examples described above, the air delivery conduit being connectable to the respiratory treatment device to receive the flow of pressurized respiratory gas from the respiratory treatment device.

[0350] In an example of the present technology, a lightweight flexible tube may be provided that includes a skeleton structure attached to an air-impermeable covering. The covering may include a woven fabric. The skeleton structure may include an array of ring members spaced along the tube. An air-impermeable fabric may surround and be bonded to the skeleton structure, thereby forming a hollow interior through which gas can be transported. The air-impermeable covering of the tube may be a laminate material, including a flexible and / or stretchable woven fabric with an air-impermeable film or other layer that allows pressurized air flow without significant surface seepage or leakage. Sealing tape may be used to seal the joint together. At this joint, the laminate overlaps itself, separating the fabric layer from the air path. The result may be an air delivery conduit that is effectively sealed, low-cost, easy to manufacture, and attractive to users.

[0351] Another aspect of the present technology relates to an air delivery conduit configured to carry a flow of pressurized respiratory gas from a respiratory pressure therapy device to a patient interface (for delivery of respiratory pressure therapy to a patient). The air delivery conduit may include a flexible reinforcing structure extending along the length of the air delivery conduit. The reinforcing structure may be configured to withstand a crushing force applied to the air delivery conduit. The air delivery conduit may also include a sealing strip attached to the reinforcing structure along the length of the air delivery conduit. The air delivery conduit may further include an air-impermeable textile covering surrounding the reinforcing structure and the sealing strip. The textile covering may form a sealed gas flow path and may include a first edge extending along the length of the air delivery conduit and a second edge opposite the first edge and extending along the length of the air delivery conduit. The first and second edges of the textile covering may meet or overlap at an inner seam. The sealing strip may also be aligned with the seam.

[0352] The longitudinal length of the reinforcement structure may be adjustable. Additionally, the textile covering may be joined to itself at a location adjacent to the inner seam. The sealing strip may be joined to the reinforcement structure and / or the textile covering. Additionally, the sealing strip may comprise a thermoplastic material. The sealing strip may be heat-bonded to the reinforcement structure and / or the textile covering. The air delivery conduit may further include an outer strip joined to the outside of the textile covering along a second edge of the textile covering. The first edge of the textile covering and / or the second edge of the textile covering may be serrated. The textile covering may have a laminate structure and may include an air-impermeable inner layer and an outer textile layer. The outer textile layer may comprise a textile material. The air-impermeable layer may comprise a thermoplastic material. The inner seam may be aligned along the centerline of the sealing strip. The reinforcement structure may include a plurality of ring members spaced apart along the length of the air delivery conduit.

[0353] Another aspect of the present technology relates to an air delivery conduit configured to carry a flow of pressurized respiratory gas under pressure from a respiratory pressure therapy device to a patient interface (for delivery of respiratory pressure therapy to a patient). The air delivery conduit may include an array of support structures. The array of support structures is spaced apart along the length of the air delivery conduit and configured to withstand a crushing force applied to the air delivery conduit. Each support structure may include an outer surface, an inner surface opposite the outer surface, and a pair of intermediate surfaces extending from the outer surface to the inner surface. The air delivery conduit may also include an air-impermeable textile covering attached to the outer surface of the support structure along the length of the air delivery conduit. The textile covering may form a sealed gas flow path. For each support structure, each intermediate surface may meet the outer surface at an outer edge, and each outer edge may be filleted or chamfered.

[0354] For each support structure, each intermediate surface may meet the inner surface at an inner edge, and each inner edge may be filleted or chamfered. The radius of curvature of the outer edge may be greater than the radius of curvature of the inner edge. The cross-section of the inner surface of each support structure may be convex. The support structures may be substantially rigid. The distance between adjacent support structures may be dynamically adjustable. In addition, each support structure may be movable toward and away from adjacent support structures. Also, each support structure may be movable relative to adjacent support structures to a position where the central longitudinal axis of the support structure is offset from and parallel to the central longitudinal axis of the adjacent support structure. The spacing between the support structures may vary along the length of the air delivery conduit. For example, the support structures may be spaced further apart at the center of the air delivery conduit than at the ends of the air delivery conduit.

[0355] The textile covering may be wrapped around the array of support structures so that the textile covering overlaps itself at the seams. The textile covering may have a seamless tubular structure. The air delivery conduit may further include a first connector at a first end configured to connect to tubing connected to an outlet of the respiratory pressure therapy device. The air delivery conduit may also include a second connector at a second end configured to connect to a patient interface.

[0356] In the example: the covering material itself is joined at a location adjacent to the seam.

[0357] In the example: the covering material is bonded to the reinforcing structure.

[0358] In the example: the covering material is bonded to the sealing strip.

[0359] In an example: the covering material comprises a textile material and the sealing strip comprises a thermoplastic material.

[0360] In an example: the air vessel further comprises an outer strip joined to the exterior of the covering along a second edge of the covering.

[0361] In an example: the first edge of the covering and / or the second edge of the covering is serrated.

[0362] In the example: the covering material has a laminate structure.

[0363] In an example: the covering comprises an air impermeable inner layer and an outer textile layer.

[0364] In an example: the air impermeable inner layer comprises a thermoplastic material.

[0365] In the example: the inner side of the seam is aligned along the centerline of the sealing strip.

[0366] In an example: the reinforcing structure includes a plurality of support structures spaced along the length of the air delivery conduit.

[0367] In an example: the air delivery conduit includes a first end configured to connect to tubing connected to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface.

[0368] The patient interface assembly may include a patient interface configured to sealingly engage a patient's face in use. The patient interface assembly may also include an air delivery conduit having any one of the reinforcing structure, connector, and covering described above. The air delivery conduit may be connectable to the patient interface to deliver pressurized breathing gas to the patient interface.

[0369] The respiratory treatment system may be configured to deliver pressurized respiratory gas to the patient's airway and may include a respiratory treatment device configured to pressurize the flow of respiratory gas. The respiratory treatment system may also include an air delivery conduit having any one of the reinforcing structure, connector, and covering material described above. The air delivery conduit may be connectable to the respiratory treatment device to receive the flow of pressurized respiratory gas from the respiratory treatment device.

[0370] Another aspect of the present technology relates to an air delivery conduit configured to convey a flow of pressurized respiratory gas from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient. The air delivery conduit may include a plurality of support structures spaced apart along the length of the air delivery conduit and configured to withstand a crushing force applied to the air delivery conduit. Each support structure may include an outer surface, an inner surface opposite the outer surface, and a pair of intermediate surfaces extending from the outer surface to the inner surface. An air-impermeable textile covering may be attached to the outer surfaces of the support structures along the length of the air delivery conduit. The textile covering may create a sealed gas flow. At least one of the support structures may include a pair of thickened portions on opposing sides of the support structure corresponding to the wider portions of the intermediate surfaces of the support structure.

[0371] The shape of the outer surface of the support structure may vary along the air delivery conduit. The shape of the outer surface of the support structure at the ends of the air delivery conduit may be different from the shape of the outer surface of the support structure at the center of the air delivery conduit. For example, the shape of the outer surface of the support structure at the ends of the air delivery conduit may be circular, and the shape of the outer surface of the support structure at the center of the air delivery conduit may be oval.

[0372] The shape of the inner surface of each support structure can be non-circular. The shape of the inner surface of each support structure can be oval. The minor axis of the oval inner shape can extend through a pair of thickened portions. The major axis of the oval inner shape can extend through a pair of thickened portions. The shape of the outer surface of each support structure can be circular. The shape of the outer surface of each support structure can be non-circular. The shape of the outer surface of each support structure can be oval. The major axis of the oval outer shape can extend through a thickened portion. The textile covering can wrap around the array of support structures such that the textile covering overlaps itself at the seams. The textile covering can have a seamless tubular structure.

[0373] Another aspect of the present technology relates to an air delivery conduit configured to deliver a flow of pressurized respiratory gas from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient. The air delivery conduit may include a plurality of support structures spaced apart along the length of the air delivery conduit. These support structures may be configured to withstand a crushing force applied to the air delivery conduit. A sealed gas flow path is formed by surrounding the support structures with a laminated air-impermeable covering, and the fabric covering may include an outer layer constructed of a fabric material and an air-impermeable inner layer. The surface area of ​​the inner layer may be greater than the surface area of ​​the outer layer, such that a flap portion of the inner layer extends beyond the outer layer. Additionally, the air-impermeable covering may overlap itself at an inner seam. The flap portion of the inner layer may sealingly contact a portion of the inner layer at the inner seam. The flap portion may be folded over the outer layer at the inner seam. The flap portion may be configured to prevent the outer layer from coming into contact with pressurized breathing gas flowing within the air delivery conduit.

[0374] The air delivery conduit may further include an inner sealing strip attached to the support structure along the length of the air delivery conduit at an inner seam. The air delivery conduit may further include an outer sealing strip attached to the outer layer at an outer seam. The air impermeable inner layer may be formed from a thermoplastic material (e.g., thermoplastic polyurethane). The thickness of the air impermeable inner layer may be about 0.5 mm or less, or about 0.15 mm or less. The textile material may have a knitted, woven, or non-woven structure. The weight of the covering material may be about 250 GSM or less, or about 180 GSM or less. The distance at which these support structures are spaced may be within a range of 1 mm to 9 mm, a range of 2 mm to 6 mm, a range of 2 mm to 3 mm, about 6 mm or less, or about 3 mm or less.

[0375] Another aspect of the present technology relates to an air delivery conduit configured to convey a flow of pressurized respiratory gas from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient. The air delivery conduit may include a flexible reinforcing structure extending along the length of the air delivery conduit. The reinforcing structure may be configured to withstand a crushing force applied to the air delivery conduit. A textile covering may be attached to the reinforcing structure along the length of the air delivery conduit. A sealing layer may form a sealed gas flow path. The reinforcing structure may be disposed between the textile covering and the sealing layer.

[0376] The reinforcement structure may include a plurality of support structures spaced apart along the length of the air delivery conduit. The sealing layer may be formed from a thermoplastic material. The textile covering may have a knitted structure. The sealing layer may be heat-bonded to the reinforcement structure and / or the textile covering. The sealing layer may include a single film layer. The sealing layer may include an inner film layer and an outer film layer. The inner film layer may be configured to be hydrolytically resistant and / or antibacterial. The inner film layer may include an ether-type TPU. The outer film layer may have a lower softening temperature than the inner film layer. The textile covering may be seamless. The textile covering may surround the reinforcement structure. The air delivery conduit may be connectable to a patient interface to deliver pressurized respiratory gas to the patient interface.

[0377] Another aspect of the present technology relates to a method of manufacturing an air delivery conduit configured to convey a flow of pressurized respiratory gas from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient. The method may include applying a tubular textile covering to the exterior of an elongated reinforcement structure. The reinforcement structure may be configured to withstand a crushing force applied to the air delivery conduit. A tubular sealing liner may be inserted into the interior of the reinforcement structure. When the tubular sealing liner is expanded, an outer surface of the tubular sealing liner contacts an inner surface of the tubular textile covering. The tubular sealing liner may be attached to the tubular textile covering. The tubular sealing liner may form a sealed gas flow path within the air delivery conduit.

[0378] The tubular textile covering may be slid over the reinforcement structure in the direction of the longitudinal axis of the mandrel. The tubular textile covering may surround the reinforcement structure. The reinforcement structure may be slid into the tubular textile covering. The tubular textile covering may be preheated before insertion of the tubular sealing liner. Preheating of the tubular textile covering may be performed by blowing hot air onto the tubular textile covering. The tubular sealing liner may be supported on the mandrel, and the tubular sealing layer may be inserted into the interior of the reinforcement structure by inserting the mandrel into the interior of the reinforcement structure. Blowing hot air onto the inner surface of the tubular sealing liner may expand the tubular sealing liner and bond it to the tubular textile covering. The mandrel may have a low-friction surface. The tubular sealing layer may be mounted on a balloon supported on the mandrel, and the tubular sealing layer may be inserted into the interior of the reinforcement structure by inserting the balloon and mandrel into the interior of the reinforcement structure. The balloon may be inflated with hot air, which expands the tubular sealing film and bonds it to the tubular fabric covering.

[0379] Another aspect of the present technology relates to a method of manufacturing an air delivery conduit configured to convey a flow of pressurized respiratory gas from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient. The method may include forming a tubular woven covering. An elongated reinforcing structure may be supported on a mandrel. The reinforcing structure may be configured to withstand a crushing force applied to the air delivery conduit. One end of the tubular woven covering may be wound onto itself. The wound end of the tubular woven covering may be attached to the mandrel. The tubular woven covering may be wound along the length of the mandrel and the reinforcing structure such that the remaining portion of the tubular woven covering is wound onto itself and the tubular woven covering is completely inverted. The mandrel may be removed from the tubular woven covering and the reinforcing structure.

[0380] The tubular woven covering may include a woven fabric layer and an air-impermeable layer. Before the tubular woven covering is wound onto the mandrel and reinforcing layer, the woven fabric layer may be provided on the inside of the tubular woven covering, and the air-impermeable layer may be provided on the outside of the tubular woven covering. The woven fabric layer may be woven or knitted. The reinforcing structure may be supported on the mandrel by compressing the mandrel, mounting the reinforcing structure on the mandrel, and expanding the mandrel. When the mandrel is compressed, the reinforcing structure is released after the tubular woven covering is fully inverted. The reinforcing structure may be bonded to the tubular woven covering. The reinforcing structure may be bonded to the tubular woven covering by thermal bonding or ultrasonic welding.

[0381] Another aspect of the present technology relates to a method of manufacturing an air delivery conduit configured to carry a flow of pressurized respiratory gas under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient. The method may include securing a tubular woven fabric covering to a support in a manner such that an enclosed space is maintained around the exterior of the tubular woven fabric covering. Expansion of the tubular woven fabric covering may be achieved by creating a pressure differential between the interior of the tubular woven fabric covering and the enclosed space around the exterior of the tubular woven fabric covering. An elongated reinforcing structure may be inserted into the interior of the tubular woven fabric covering, the reinforcing structure configured to withstand a crushing force applied to the air delivery conduit. Reducing the pressure differential between the interior of the tubular woven fabric covering and the enclosed space around the exterior of the tubular woven fabric covering may allow the tubular woven fabric covering to contact the reinforcing structure.

[0382] This pressure differential can be created by increasing the air pressure inside the tubular textile covering. This pressure differential can be created by decreasing the air pressure in the enclosed space around the exterior of the tubular textile covering. The support can be a vacuum fixture. The vacuum fixture can create a vacuum in the enclosed space around the tubular textile covering. The diameter of the vacuum fixture can be larger than the diameter of the tubular textile covering, allowing the tubular textile covering to expand. The elongated reinforcing structure can be mounted on a mandrel and then inserted into the interior of the tubular textile covering. The mandrel can be removed from the interior of the tubular textile covering, and the reinforcing structure can remain within the tubular textile covering. The elongated reinforcing structure can include a plurality of spaced apart support structures. The diameter of the support structures can be larger than the diameter of the tubular textile covering when the tubular textile covering is in contact. After the mandrel is removed from the interior of the tubular woven fabric covering, grooves may be provided in the tubular woven fabric covering between adjacent pairs of support structures.

[0383] The mandrel may include a plurality of teeth. The plurality of teeth is configured to allow the support structure to slide along the mandrel in a first direction and prevent the support structure from sliding along the mandrel in a second direction opposite the first direction. Each tooth may include a first wall and a second wall, the first wall being tapered relative to a central axis of the mandrel. The second wall may be perpendicular to the central axis of the mandrel. The first wall may be configured to allow the support structure to slide over each tooth in the first direction, and the second wall may be configured to prevent the support structure from sliding along the mandrel in the second direction. The plurality of teeth may be grouped into sets of teeth spaced longitudinally along the tooth mandrel. Each set of teeth may be configured to prevent the support structure from sliding along the mandrel in the second direction. Each set of teeth may include a plurality of teeth radially arranged about the central axis of the mandrel. The teeth may be biased to an outwardly protruding position relative to the central axis of the mandrel and may be depressible inwardly relative to the central axis of the mandrel, allowing the support structure to slide in a first direction over the teeth. The teeth may be spring-biased to the outwardly protruding position. The tubular woven covering may be at least partially bonded to the reinforcement structure, after which the mandrel is removed from the interior of the tubular woven covering. The tubular woven covering may be bonded to the reinforcement structure after the mandrel is removed from the interior of the tubular woven covering. The tubular woven covering may be heat-bonded, ultrasonically welded, or adhesively attached to the reinforcement structure.

[0384] Another aspect of the present technology relates to an air delivery conduit. The air delivery conduit may include any one of the reinforcing structures, connectors, and coverings described above, and may further include a first connector at a first end configured to connect to tubing connected to an outlet of a respiratory pressure therapy device. The air delivery conduit may also include a second connector at a second end configured to connect to a patient interface.

[0385] Another aspect of the present technology may relate to a patient interface assembly that may include a patient interface configured to sealingly engage a patient's face in use. The patient interface assembly may also include an air delivery conduit having any one of the reinforcing structures, connectors, and coverings described above. The air delivery conduit may be connectable to the patient interface to deliver pressurized breathing gas to the patient interface.

[0386] Another aspect of the present technology relates to a respiratory treatment system. The respiratory treatment system may be configured to deliver pressurized respiratory gas to a patient's airway and may include a respiratory treatment device configured to pressurize the flow of respiratory gas. The respiratory treatment system may also include an air delivery conduit having any one of the reinforcing structures, connectors, and coverings described above. The air delivery conduit may be connectable to the respiratory treatment device to receive the flow of pressurized respiratory gas from the respiratory treatment device.

[0387] A soft and comfortable air delivery conduit may be desirable for patients. For example, patients may find it more comfortable to sleep on an air delivery conduit with a soft, pleasant-to-the-touch exterior. If a patient views the treatment device as comfortable and desirable, their compliance with treatment may be improved. Having a textile surface on the flexible tubing that provides the air flow path between the respiratory pressure treatment device and the patient interface, with high air retention and lightweight construction, provides the necessary function and comfort for treatment, while also providing aesthetics and consumer appeal.

[0388] In contrast to the cold and stiff feel of some existing plastic tubes, an air delivery conduit having an outer surface formed from a woven material may have a soft and warm feel. If a patient's device is comfortable and desirable, their compliance with treatment may be higher. Woven tubes may have an appearance more similar to bedding than medical devices. When the surface of a woven tube is rubbed, it may be quieter than plastic tubes. Woven tubes may also have lower tube drag because they may weigh less per unit length than plastic tubes. Furthermore, a wider variety of tube cross sections, such as low-profile cross sections (e.g., ovals), may be achievable with woven tubes.

[0389] Another aspect of the present technology relates to a patient interface configured to deliver a flow of breathable gas under pressure from a respiratory pressure therapy device for delivery of respiratory pressure therapy to a patient, the patient interface including: Positioning and stabilizing structures, Seal forming structure, the positioning and stabilizing structure includes at least one headgear tube configured to be positioned against at least one of a surface of the patient's head or a surface of the patient's face in use; At least one headgear tube includes at least one resilient support element.

[0390] In an example: the positioning and stabilising structure includes a first headgear tube and a second headgear tube.

[0391] In an example: the first headgear tube and the second headgear tube are configured to extend from the joint across each side of the patient's head and across each cheek of the patient's head in use and to connect to the sealing-forming structure.

[0392] In examples: the joint is placed above or behind the patient's head.

[0393] In an example: the headgear tube(s) have a non-circular cross-sectional area in a plane substantially perpendicular to the length of the tube(s).

[0394] In an example: the headgear tube(s) include a patient-contacting portion and a non-contacting portion, which together define a conduit that, in use, provides a pathway for facilitating delivery of breathable gas to the seal-forming structure.

[0395] In an example: the conduit defined by the patient-contacting portion and the non-contacting portion has a substantially semi-circular cross-sectional area in a plane oriented substantially perpendicular to the longitudinal axis of the headgear tube.

[0396] In an example: the patient contacting portion is substantially planar and the non-contacting portion is curved in shape, the planar and curved shapes defining a semi-circular cross-sectional area.

[0397] In the example: the patient contacting portion and the non-contacting portion are separate parts from each other.

[0398] In examples: the separate parts are attached to each other by RF welding or adhesive bonding.

[0399] In an example: at least one of the patient-contacting portion and the non-contacting portion includes at least one layer of textile material.

[0400] In the example: the elastic support element is provided on the non-contact part.

[0401] In an example: the headgear tube includes a plurality of resilient support elements spaced apart from one another along the length of the headgear tube(s).

[0402] In the example: the headgear tube comprises a single elastic support element.

[0403] In an example: the single elastic element is a single bead of material, having a spiral or helix shape that extends along the length of the tube(s).

[0404] Another aspect of the present technology is a headgear tube for a positioning and stabilizing structure, the headgear tube being configured, in use, to convey a flow of breathable air under pressure from a respiratory pressure treatment device to a seal-forming structure for delivery of respiratory pressure treatment to a patient, the headgear tube including: a patient-contacting portion configured to be positioned against at least one of a surface of the patient's head or a surface of the patient's face in use; At least one headgear tube includes a resilient support member.

[0405] In an example, the positioning and stabilizing structure includes a first headgear tube and a second headgear tube configured to extend from a joint across each side of the patient's head and across each cheek of the patient's face to connect to the seal-forming structure in use. The joint may be located on the top or back of the patient's head. At least one of the first headgear tube and the second headgear tube includes at least one elastic support element, and preferably both the first headgear tube and the second headgear tube include at least one elastic support element.

[0406] In examples, headgear tube(s) according to the present technology may have a non-circular cross-sectional area in a plane substantially perpendicular to the length of the tube(s). The cross-sectional area may be substantially semicircular, triangular, or oval. For example, the cross-sectional area may be defined by a substantially linear / straight section and an arcuate section.

[0407] In examples, the headgear tube(s) include a patient-contacting portion and a non-contacting portion that together define a conduit configured to facilitate delivery of a flow of breathable gas to the seal-forming structure in use.

[0408] In examples, the patient-contacting portion and the non-patient-contacting portion are separate parts that are attached to one another. The attachment of these separate parts to one another results in at least one joint. The parts may be attached together by RF welding, adhesive, or other techniques.

[0409] In examples, at least a portion of the patient contacting portion is constructed from a soft, flexible material.

[0410] In examples, at least one, and preferably both, of the patient-contacting and non-contacting portions include at least one layer of woven material from which the outer layer of the headgear tube(s) can be derived.

[0411] In examples, headgear tubes according to the present technology can be substantially gas impermeable, e.g., the patient-contacting portion and the non-contacting portion can include at least one layer of gas-impermeable material.

[0412] In examples, the patient-contacting portion includes a layer of fabric material and at least one layer of cushioning material, which may be one or more layers of foam or other soft and flexible material.

[0413] In examples, at least one resilient support member may be provided in the non-contacting portion and optionally in the patient-contacting portion.

[0414] In an example: at least one headgear tube includes a plurality of elastic support elements spaced apart from one another along the length of the headgear tube, hi another example, the elastic support element may be a single bead having a spiral or helical shape and extending along the length of the tube.

[0415] In examples, the elastic support element(s) are formed from one or more materials selected from the following list: silicone, polyurethane (PU), TPU or other suitable elastic material.

[0416] In an example: the conduit defined by the patient-contacting portion and the non-contacting portion has a substantially semi-circular cross-sectional area in a plane oriented substantially perpendicular to the longitudinal axis of the headgear tube.

[0417] In an example: the patient contacting portion is substantially planar and the non-contacting portion is curved in shape, the planar and curved shapes defining a semi-circular cross-sectional area.

[0418] In the example: the patient contacting portion and the non-contacting portion are separate parts from each other.

[0419] In examples: the separate parts are attached to each other by RF welding or adhesive bonding.

[0420] In an example: at least one of the patient-contacting portion and the non-contacting portion includes at least one layer of textile material.

[0421] In the example: the elastic support element is provided on the non-contact part.

[0422] In an example: the headgear tube includes a plurality of resilient support elements spaced apart from one another along the length of the headgear tube.

[0423] In the example: the headgear tube comprises a single elastic support element.

[0424] In examples: textile materials include knitted materials or woven fabrics.

[0425] In an example: the woven material includes a layer of coating material to render the woven material substantially gas impermeable.

[0426] In examples: the coating material is glue or adhesive.

[0427] In the example: the elastic support element(s) are provided directly on the coating material.

[0428] In an example: the patient-contacting portion includes at least one layer of foam.

[0429] In an example: the headgear tube includes a first connector disposed at a first end of the headgear tube and a second connector disposed at a second end of the headgear tube.

[0430] In an example: the first connector is configured to attach the headgear tube to the patient interface in use.

[0431] In an example: the second connector is configured to connect, in use, to a supply of breathable gas.

[0432] Another aspect of the present technology relates to a method of manufacturing a component of a respiratory treatment system, the method including:

[0433] 1. Using weaving and knitting techniques to form at least a portion of the knitted structure; 2. adding elastic material to the portion of the knitted structure formed in step (1); 3. Using a continuous weaving / knitting technique to form additional sections or sections of the knitted structure; and 4. adding elastic material to additional portions or portions of the knit formed in step (3); 5. Repeating steps (3) and (4) until the desired knitted structure is produced. In examples, this weaving technique may include circular weaving, thus forming at least a portion of the woven tubular structure, although other weaving techniques are possible for other shapes and configurations of components produced according to the methods of the present technology.

[0434] In examples, the method can include attaching a second layer of material to the knitted structure. The attachment of the second layer can occur after or simultaneously with the application of the elastic material to the knitted structure.

[0435] In examples, the method may include the step of curing the elastic material after application of the elastic material to the knitted structure.

[0436] In the example: weaving techniques include circular weaving.

[0437] In an example: step (1) forms at least a portion of a tubular structure.

[0438] In an example: the method further includes attaching a second layer of material to the knitted structure.

[0439] In an example: the attachment of the second layer occurs after the application of the elastic material to the knitted structure or simultaneously with the application of the elastic material to the knitted structure.

[0440] In an example: the method includes the step of curing the elastic material after application of the elastic material to the knitted structure.

[0441] Another aspect of the present technology relates to a system configured to manufacture a component of a respiratory treatment system, the system including: a woven / knitted module configured to form at least a portion of a knitted structure; A distribution module configured to apply elastic material to the portion of the knitted structure produced by the weave / knit module.

[0442] In examples, the system may be configured to continuously produce a knitted structure and to add elastic material to the knitted structure after the knitted structure is produced. For example, the weaving / knitting module and the distribution module may be positioned relative to one another to allow elastic material to be added from the distribution module to a portion of the knitted structure as the weaving / knitting module continuously produces additional portions of the knitted structure.

[0443] In examples, a weaving / knitting module can include at least one spool (e.g., two or more spools) that can include the same or different yarns that can be selected to achieve desired properties in the knitted structure produced by the system.

[0444] In examples, the weaving module may include a drive mechanism configured to move the yarn(s) relative to the weaving elements to produce a portion of the knitted structure.

[0445] In examples, the system may include a curing tool configured to accelerate or otherwise assist in curing the elastic material after it has been applied to the portion of the knitted structure. The curing tool may be a UV light source, a heat source, or other component.

[0446] In an example: the system is configured to continuously produce a knitted structure and to add elastic material to the knitted structure after the knitted structure is produced.

[0447] In an example: the relative positioning of the weaving / knitting module and the distribution module is such that the weaving / knitting module is capable of adding elastic material from the distribution module to a portion of the knitted structure as the weaving / knitting module continuously produces additional sections of the knitted structure.

[0448] In an example: the weaving module includes at least one spool.

[0449] In an example: the system further includes a second spool.

[0450] In the example: a first spool contains a first type of thread and a second spool contains a second type of thread.

[0451] In an example: the weaving module includes a drive mechanism and a weaving element, and in use, the drive mechanism is configured to move the yarn(s) relative to the weaving element to produce a portion of the knitted structure.

[0452] In examples: the system may further include a stiffening tool configured to accelerate or otherwise assist in stiffening of the elastic material after the elastic material has been applied to the portion of the knitted structure.

[0453] In examples: the curing tool is a UV light source or a heat source.

[0454] Another aspect of the present technology relates to a method of manufacturing a component of a respiratory treatment system, the method including: 1. Selecting, forming, or manufacturing sheets of material; 2. forming at least one elastic support element by adding elastic material to produce a base sheet; and 3. Manipulating the base sheet to obtain a desired shape or configuration to provide at least a portion of a component of a respiratory treatment system.

[0455] In examples, the sheet of material may be a textile material (e.g., a knitted, woven, or mesh material), however, the sheet of material may also be molded or extruded from a plastic material.

[0456] In an example, the sheet of material may be a coated sheet of material, manufactured according to the methods described herein.

[0457] In examples, the method includes attaching a base sheet to a second portion to form a component. The base sheet and second portion can, in at least one embodiment, be different from one another (e.g., the second portion may not include an elastic support member). Alternatively, the second portion can be formed from a different material than the sheet of material forming the base sheet.

[0458] In examples, the attachment of the base sheet to the second portion can form a structure having a non-circular cross-sectional area in a plane substantially perpendicular to the length of the component, for example, the component can have a semi-circular cross-sectional area.

[0459] In other examples, a component may be formed by attaching a base sheet to itself, for example, the base sheet may be manipulated into a cylindrical or tubular shape and joints formed to attach surfaces of the base sheet together.

[0460] In examples, the method may include RF welding to form joints to attach portions of the components together.

[0461] In examples, the method can include applying a second layer of material to the base sheet. The second layer of material can be a gas-impermeable layer. In embodiments, attaching the second layer of material includes attaching a sheet of material to the base sheet (e.g., a pre-formed thin film material). Alternatively, applying the second layer of material can include injecting a liquid onto the base sheet and spreading the liquid after application of individual droplets of the liquid to produce the second layer. The liquid can be hardened after application to the base sheet.

[0462] In an example, in the step of forming the elastic support element(s), a relatively thin layer of elastic material is also formed on the sheet of material.

[0463] In examples: the sheet of material is a textile material or a plastic material.

[0464] In examples: the textile material is a knitted material, a woven material or a mesh material.

[0465] In an example: the method further includes attaching the base sheet to a second portion to form a component.

[0466] In an example: the step of attaching the base sheet to the second portion includes forming a structure with a non-circular cross-sectional area in a plane substantially perpendicular to the length of the component.

[0467] In an example: the method further includes forming a joint for attaching the two portions of the component together by RF welding.

[0468] In an example: the method further comprises providing a second layer of material to the base sheet.

[0469] In an example: the step of providing the second layer of material includes attaching a pre-formed thin film.

[0470] In an example: the step of providing the second layer of material includes injecting a liquid onto the base sheet and allowing the liquid to harden.

[0471] In an example: in the step of forming the elastic support element(s), a relatively thin layer of elastic material is also formed on the sheet of material.

[0472] Another aspect of the present technology relates to components of a respiratory treatment system, including: a layer of textile material; a coating material layer adhered to the layer of fabric material, the coating material layer providing a substantially gas impermeable layer for the component, the coating material being an adhesive; and A resilient support element provided on the coating material.

[0473] In an example, the coating material may be a polyurethane (PU) adhesive.

[0474] In examples, the elastic element may be constructed from an elastic material (eg, silicone).

[0475] In an example, the coating material and the elastic material are different from each other, for example, the coating material can be a polyurethane (PU) adhesive and an elastic material.

[0476] In examples, the coating material may be in at least partial contact with the air path, e.g., in these embodiments, the component does not include an additional liner or layer of material to render the woven material completely or partially gas impermeable.

[0477] Another aspect of the present technology relates to a method of forming a component of a respiratory treatment system, the method including the steps of: 1) providing a layer of textile material; 2) applying a coating material to the textile material to produce a coated textile material, the coating material producing a substantially gas impermeable layer; 3) adding an elastic material to the coating material to produce a base sheet having at least one elastic support element; 4) Manipulating the coated woven material into a desired shape corresponding to the shape of the component.

[0478] In examples, the step of applying the coating material may include applying individual droplets of the coating material to the textile material, pouring a liquid onto the textile material, or other suitable method.

[0479] In an example, the method includes applying a liner material to the coating material. The method may also include removing the liner material, for example, after the coating material has cured. For example, the liner may not adhere to the coating material.

[0480] In examples, the method can include spreading the coating material over the textile material. For example, the method can use a knife spreader or drum applicator, as known to those skilled in the art.

[0481] In examples, the step of applying the elastic material may occur after the coating material has substantially or fully cured, however, the application of the elastic material may occur immediately after applying the coating material to the textile material.

[0482] 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.

[0483] 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.

[0484] 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).

[0485] An aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.An aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0486] The described methods, systems, devices, and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor in a special purpose computer, a respiratory monitor, and / or a respiratory treatment device). Further, the described methods, systems, devices, and apparatus enable advancements in the art of automated management, monitoring, and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0487] 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.

[0488] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.

[0489] 4 Brief description of the drawings The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include like elements: [Brief explanation of the drawings]

[0490] [Figure 1A] 4.1 Treatment System: A system is shown including a patient 1000 wearing a patient interface 3000. The system 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 positive pressure air supply 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 sleep position. 4.2 Respiratory System and Facial Anatomy [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 septal cartilage and the medial crus of the greater alar cartilage. [Figure 2J] FIG. 1 is a frontal bony view of the skull, including the frontal, nasal, and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 2K] This is a 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 side of the nose. 4.3 Patient Interface [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 and saddle regions are shown. [Figure 3H] 1 shows a cushion for a mask. The outer surface of the cushion is illustrated. The edge of the surface is illustrated. The path on the surface between points A and B is illustrated. The linear distance between A and B is illustrated. Two saddle regions and a dome region are illustrated. [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. 4.4 RPT Device [Figure 4A]1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] 4.5 Humidifiers [Figure 5A]

[0023] Fig. 10 shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B] 5 shows 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. 4.6 Respiratory Waveforms [Figure 6A] A typical respiratory waveform of a sleeping human model is shown. 4.7 Example of a patient interface for this technology [Figure 7A] FIG. 43 shows a side view of a portion of an air delivery conduit 4300 according to an example of the present technology. [Figure 7B] 7B is a cross-sectional view of the air delivery conduit 4300 shown in FIG. 7A. [Figure 7C] FIG. 43 is a side view of an air delivery conduit 4300 in accordance with another example of the present technology. [Figure 8] 4 shows a support structure 4310 according to an example of the present technology. [Figure 9] 8. The support structure 4310 of FIG. 8 is shown. [Figure 10] 43A shows a cross-sectional view of a support structure 4310 according to another embodiment of the present technology. [Figure 11] 43A shows a cross-sectional view of a support structure 4310 according to another embodiment of the present technology. [Figure 12A] 43 shows a support structure 4310 according to another embodiment of the present technology. [Figure 12B] 43 shows a support structure 4310 according to another embodiment of the present technology. [Figure 12C] 43 shows a support structure 4310 according to another embodiment of the present technology. [Figure 12D] 43 shows a support structure 4310 according to another embodiment of the present technology. [Figure 12E] 43 shows a support structure 4310 according to another embodiment of the present technology. [Figure 12F] 43 shows a support structure 4310 according to another embodiment of the present technology. [Figure 12G] 43 shows a support structure 4310 according to another embodiment of the present technology. [Figure 12H] 43 shows a support structure 4310 according to another embodiment of the present technology. [Figure 12I] 43 shows a support structure 4310 according to another embodiment of the present technology. [Figure 13] FIG. 43 is a cross section view of an air delivery conduit 4300 in accordance with another example of the present technology. [Figure 14] FIG. 43 is a cross section view of an air delivery conduit 4300 in accordance with another example of the present technology. [Figure 15] FIG. 43 is a cross section view of an air delivery conduit 4300 in accordance with another example of the present technology. [Figure 16A] 43 shows a ring member 4310 according to another embodiment of the present technology. [Figure 16B] 43 shows a ring member 4310 according to another embodiment of the present technology. [Figure 17] 43 shows a ring member 4310 according to another embodiment of the present technology. [Figure 18] 43 shows an array of multiple support structures 4310 according to another embodiment of the present technology. [Figure 19] 19 shows a portion of an air delivery conduit 4300 in accordance with another embodiment of the present technology, including the support structure 4310 of FIG. 18. [Figure 20] 43 shows an array of multiple support structures 4310 according to another embodiment of the present technology. [Figure 21] 21 shows a portion of an air delivery conduit 4300 in accordance with another embodiment of the present technology, including a support structure 4310 of FIG. 20. [Figure 22] 43 shows a reinforcement structure 4305 in accordance with another example of the present technology. The reinforcement structure 4305 includes a support structure 4310. [Figure 23] FIG. 23 is a schematic diagram of the support structure 4310 of FIG. 22 around the mandrel 7000. [Figure 24] The reinforcement structure 4305 of FIG. [Figure 25] FIG. 25 is a schematic diagram of the assembly shown in FIG. 24. [Figure 26] The reinforcing structure 4305 and sealing layer 4351 of FIG. 24 are shown with the outer sheet 4342. [Figure 27] 27 is a schematic diagram of the assembly shown in FIG. 26 with the outer sheet 4342 surrounding the reinforcement structure 4305. [Figure 28] 43 shows a portion of an air delivery tube 4300 in accordance with an example of the present technology. [Figure 29] FIG. 29 is a schematic diagram of the air delivery tube 4300 of FIG. 28. [Figure 30] FIG. 29 is a schematic cross-sectional view of a portion of the air delivery tube 4300 of FIG. 28. [Figure 31] 43 shows a schematic cross-sectional view of a portion of an air delivery tube 4300 in accordance with another example of the present technology. [Figure 32] 43 shows a schematic cross-sectional view of a portion of an air delivery tube 4300 in accordance with another example of the present technology. [Figure 33] FIG. 43 shows a cross section of a portion of an air delivery conduit 4300 (before addition of a sealing layer 4341) in accordance with another example of the present technology. [Figure 34] FIG. 34 is a cross-sectional view of the air delivery conduit 4300 of FIG. 33 during a preheating step. [Figure 35] 34 is a cross-sectional view of the air delivery conduit 4300 of FIG. 33 upon insertion of the sealing layer 4341. FIG. [Figure 36] FIG. 34 is a cross-sectional view of the air delivery conduit 4300 of FIG. 33 during the bonding step. [Figure 37] FIG. 43 shows a cross section of an air delivery conduit 4300 with a sealing layer 4341 inserted in accordance with another example of the present technology. [Figure 38] FIG. 38 is a cross-sectional view of the air delivery conduit 4300 of FIG. 37 during the bonding step. [Figure 39] FIG. 34 is a cross-sectional view of the air delivery conduit 4300 of FIG. 33 with a sealing layer 4341 added. [Figure 40A]FIG. 43 is a cross section of a portion of an air delivery conduit 4300 in accordance with another example of the present technology. [Figure 40B] FIG. 43 is a perspective view of a portion of an air delivery conduit 4300 in accordance with another example of the present technology. [Figure 40C] FIG. 43 is a cross section of a portion of an air delivery conduit 4300 in accordance with another example of the present technology. [Figure 41] FIG. 40 shows a schematic diagram of inserting a sealing layer 4341 into an outer layer 4342 to form a covering 4340 according to an example of the present technology. [Figure 42] FIG. 42 is a schematic diagram of how the covering material 4340 of FIG. 41 is applied to the reinforcement structure 4305. [Figure 43] FIG. 43 is a schematic diagram of a covering 4340, in accordance with another example of the present technology. [Figure 44] FIG. 70 is a schematic diagram of a mandrel 7000 in a compressed state according to an example of the present technology, according to another example of the present technology. [Figure 45] FIG. 45 is a schematic diagram of the mandrel 7000 of FIG. 44 in a compressed state (supporting a reinforcing structure 4305). [Figure 46] FIG. 46 is a schematic diagram of the mandrel 7000 of FIG. 44 in an expanded state (supporting the reinforcing structure 4305 of FIG. 45). [Figure 47] FIG. 45 is a schematic diagram of the application of a covering material 4340 to a reinforcement structure 4305 supported on the mandrel 7000 of FIG. [Figure 48] FIG. 45 is a detailed schematic diagram of the application of a covering material 4340 to a reinforcement structure 4305 supported on the mandrel 7000 of FIG. [Figure 49] FIG. 45 is a schematic diagram of the application of a covering material 4340 to a reinforcement structure 4305 supported on the mandrel 7000 of FIG. [Figure 50] FIG. 45 is a schematic diagram of the mandrel 7000 of FIG. 44 in a compressed state upon removal from the reinforcement structure 4305. [Figure 51] FIG. 45 is a schematic diagram of the mandrel 7000 of FIG. 44 being removed from the air delivery conduit 4300. [Figure 52]FIG. 7 is a schematic diagram of a covering material 4340 supported by a vacuum fixture 7100, in accordance with another example of the present technology. [Figure 53] FIG. 53 is a schematic diagram of the covering material 4340 of FIG. 52 supported by a vacuum fixture 7100 with the application of a vacuum. [Figure 54] FIG. 7 is a schematic diagram of a mandrel 7000 with a ring member 4310 of a reinforcement structure 4305 being slid onto the mandrel 7000, in accordance with another example of the present technology. [Figure 55] FIG. 55 is a detailed schematic diagram of the mandrel 7000 and ring member 4310 of FIG. 54. [Figure 56] FIG. 55 is a schematic diagram of the mandrel 7000 of FIG. 54 supporting a reinforcing structure 4305. [Figure 57] FIG. 53 is a schematic diagram of the mandrel 7000 and reinforcing structure 4305 inserted into the covering material 4340 of FIG. 52 by vacuum applied from the vacuum fixture 7100. [Figure 58] FIG. 53 is a schematic diagram of the mandrel 7000 and reinforcing structure 4305 inserted into the covering material 4340 of FIG. 52 after the vacuum has been released. [Figure 59] 53 is a schematic diagram of the mandrel 7000 when it is retracted from the inside of the cover material 4340 in FIG. 52. FIG. [Figure 60] FIG. 43 is a schematic diagram of an air delivery conduit 4300 in accordance with another example of the present technology. [Figure 61] FIG. 43 is a schematic diagram of an air delivery conduit 4300 in accordance with another example of the present technology. [Figure 62] 62 is a schematic diagram of the sealing layer 4341 prior to insertion into the outer layer 4346 during manufacture of the air delivery conduit 4300 of FIG. 61. FIG. [Figure 63] FIG. 63 is a schematic diagram of the sealing layer 4341 and outer layer 4346 of FIG. 62 in a mold 7200. [Figure 64] FIG. 64 is a schematic diagram of the air delivery conduit 4300 of FIG. 61 formed in the mold 7200 of FIG. 63. [Figure 65] FIG. 43 is a schematic diagram of an air delivery conduit 4300 in accordance with another example of the present technology. [Figure 66-1]FIG. 30 is a front view of a patient interface 3000 in accordance with another embodiment of the present technology. [Figure 66-2] FIG. 66-2 is a side view of the patient interface 3000 of FIG. 66-1. [Figure 66-3] FIG. 66-2 is a perspective view of the patient interface 3000 of FIG. 66-1. [Figure 67-1]

[0023] FIG. 1 shows a first perspective view of a headgear tube in accordance with aspects of the present technology. [Figure 67-2] A second perspective view of the headgear tube of Figure 67-1. [Figure 67-3] Figures 67-1 and 67-2 are end-on views of the headgear tube. [Figure 67-4] 12 is a cross-sectional view of a headgear tube in accordance with aspects of the present technology; [Figure 68] 1 is a schematic illustration of a system configured for use in a method of manufacturing an air delivery conduit, in accordance with aspects of the present technique; [Figure 69] 1 illustrates exemplary steps in a method for producing an elastic support member on a woven material, in accordance with aspects of the present technique. [Figure 70] 1 illustrates exemplary steps in a method according to aspects of the present technology, and exemplary components of a respiratory device manufactured according to the method. [Figure 71-1] 71 illustrates a further embodiment of the method of FIG. 70 and a component manufactured according to the method. [Figure 71-2] 71-1 shows a further embodiment of the method and a component manufactured according to the method. [Figure 71-3] 71-1 shows a further embodiment of the method and a component manufactured according to the method. [Figure 72] 71 illustrates a further embodiment of the method of FIG. 70 and a component manufactured according to the method. [Figure 73] FIG. 73 is a cross-sectional view of a multi-layer structure fabricated according to the method of FIG. 72. [Figure 74] 74 illustrates a further embodiment of the method of FIG. 73 and a component manufactured according to the method. [Figure 75]1 is a cross-sectional view of a conduit in accordance with an aspect of the present technology; [Figure 76] 14 is a representative illustration of a resilient support element in accordance with aspects of the present technology; [Figure 77] 66 illustrates exemplary steps in a method 6600 according to aspects of the present technology, and components generated according to the method. [Figure 78] 67 illustrates exemplary steps in a method 6700 in accordance with aspects of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0491] 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.

[0492] 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.

[0493] 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.

[0494] 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.

[0495] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.

[0496] 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.

[0497] 5.3 Patient Interface 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.

[0498] 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.

[0499] 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.

[0500] 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.

[0501] 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.

[0502] 5.3.1 Seal formation structure In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further provide a cushioning function. 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 in 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).

[0503] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0504] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0505] A seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material (eg, silicone).

[0506] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate a different size and / or shape range. For example, the system may include one form of seal-forming structure 3100 that is suitable for large head sizes but not small head sizes, and another that is suitable for small head sizes but not large head sizes.

[0507] 5.3.1.1 Sealing mechanism 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.

[0508] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the peripheral length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is or includes a spring-like element that functions to support the sealing flange against buckling during use.

[0509] 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.

[0510] 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.

[0511] In one form, the seal-forming structure includes an area having a sticky or adhesive surface.

[0512] 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.

[0513] 5.3.1.2 Nasal bridge or nasal ridge area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal on the nasal bridge or nasal ridge region of the patient's face.

[0514] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the nasal bridge or nasal ridge region of the patient's face in use.

[0515] 5.3.1.3 Upper lip area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the upper lip region (ie, upper lip) of the patient's face.

[0516] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face in use.

[0517] 5.3.1.4 Jaw area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the chin area of ​​the patient's face.

[0518] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the chin region of the patient's face in use.

[0519] 5.3.1.5 Frontal area In one form, the seal-forming structure forms a seal on the forehead region of the patient's face when in use, and in such a form, the plenum chamber may cover the eyes when in use.

[0520] 5.3.1.6 Nasal pillow In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

[0521] 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, the 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 to the base of the stem. The flexible region can function to facilitate a universal joint structure. The universal 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.

[0522] 5.3.2 Plenum chamber The plenum chamber 3200 has a periphery 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 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire edge of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single, homogenous piece of material.

[0523] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eye when in use. In other words, the eye is outside the pressurized space defined by the plenum chamber. Such forms may improve treatment compliance, often resulting in less intrusiveness and / or greater wearer comfort.

[0524] In certain forms of the present technology, the plenum chamber 3200 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.

[0525] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material, which can make the patient interface less intrusive and help improve compliance with treatment.

[0526] 5.3.3 Positioning and stabilizing structures The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position by the positioning and stabilising structure 3300 in use.

[0527] In one form, the positioning and stabilizing structure 3300 provides at least enough holding force to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0528] In one form, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the attractive force on the patient interface 3000.

[0529] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0530] In one form of the present technology, there is provided a positioning and stabilizing structure 3300 configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0531] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a supine sleeping position with the posterior region of the patient's head resting on a pillow.

[0532] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleeping position with the side region of the patient's head resting on a pillow.

[0533] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a decoupling located between the front of the positioning and stabilizing structure 3300 and a posterior portion of the positioning and stabilizing structure 3300. The decoupling does not resist compression and can be a flexible or flimsy strap, for example. The decoupling is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling prevents posterior forces from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0534] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient-contacting 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 loop material that engages with portions of hook material.

[0535] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes stretchable (e.g., stretchable with elasticity) straps. For example, the straps 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 straps can be configured as ties.

[0536] 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 a superior-auricular point on the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0537] In one form of the present technology, suitable for a nasal-only or full-face mask, the positioning and stabilizing structure includes a second tie constructed and arranged such that, in use, at least a portion of its upper edge passes below the inferior ear base point on the underside of the patient's head and covers or rests below the occipital bone of the patient's head.

[0538] In one form of the present technology suitable for a nasal-only or full-face mask, the positioning and stabilizing structure includes a third tie constructed and arranged to interconnect the first tie and the second tie in a manner that reduces the tendency of the first tie and the second tie to move apart.

[0539] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps that are bendable, e.g., non-rigid. An advantage of this embodiment is that the straps are more comfortable when the patient lies down to sleep.

[0540] In a particular form of the present technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow water vapor to pass therethrough.

[0541] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300. Each positioning and stabilizing structure 3300 is 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 3300 that is suitable for large sized heads but not for small sized heads, and another form of positioning and stabilizing structure 3300 that is suitable for small sized heads but not for large sized heads.

[0542] 5.3.3.1 Conduit Headgear Positioning and Stabilization System FIGS. 66-1 to 66-3, and more particularly FIG. 66-3, show a patient interface 3000 including a plenum chamber 3200. In this example, the patient interface 3000 also includes a positioning and stabilizing structure 3300 for holding the plenum chamber 3200 in a sealing position on the patient's face during use. In this example, the positioning and stabilizing structure 3300 includes a pair of headgear tubes 3340. The pair of headgear tubes 3340 are interconnected at their upper ends and configured to be positioned on the upper and lateral surfaces of the patient's head during use, respectively. The headgear tubes 3340 are configured to be positioned between the patient's eyes and ears during use, respectively. The lower end of each headgear tube 3340 is configured to fluidly connect to the plenum chamber 3200. In this example, the lower end of each headgear tube 3340 connects to a headgear tube connector 3344. The headgear tube connector 3344 may be permanently or releasably connected to a headgear connector 3246 configured to connect to the inlet port 3240 of the plenum chamber 3200. The positioning and stabilizing structure 3300 includes a conduit headgear inlet 3390 at the junction of the two headgear tubes 3340. The conduit headgear inlet 3390 is configured to receive a pressurized gas flow, for example, via an elbow including a connection port 3600, and to direct the gas flow into the hollow interior of the headgear tube 3340. These headgear tubes 3340 provide the pressurized gas flow to the plenum chamber 3200.

[0543] The positioning and stabilizing structure 3300 may include one or more straps in addition to the headgear tubes 3340. In this example, the positioning and stabilizing structure 3300 includes a pair of upper straps 3310 and a pair of lower straps 3320. The rear ends of the upper straps 3310 and lower straps 3320 are joined to one another. The joint between the upper straps 3310 and lower straps 3320 is configured to be positioned on the rear of the patient's head, thereby allowing the upper straps 3310 and lower straps 3320 to be anchored. The front end of the upper strap 3310 connects to a headgear tube 3340. In this example, each headgear tube 3340 includes a tab 3342 with an opening through which each upper strap 3310 can be routed and then looped back to secure the upper headgear strap 3310 to the headgear tube 3340. The positioning and stabilizing structure 3300 also includes a lower strap clip 3326 provided to the front end of each lower strap 3320. The lower strap clips 3326 are each configured to connect to a lower connection point 3325 on the plenum chamber 3200, which in the example of FIGS. 61-1 to 61-3 is provided on the headgear connector 3246. In this example, the lower strap clips 3326 are magnetically secured to the lower connection points 3325. In some examples, a mechanical engagement is also provided between the lower strap clips 3326 and the lower connection points 3325.

[0544] The headgear tube connectors 3344 may be configured to allow the patient to breathe ambient air when there is no pressure in the plenum chamber 3200. Each headgear tube connector 3344 may include an anti-asphyxiation valve (AAV). The AAV in each headgear tube connector 3344 may be configured to open when there is no pressure in the plenum chamber 3200 to allow air flow between the interior of the plenum chamber 3200 and the ambient. Each AAV may be biased into a configuration that blocks air flow from the interior of the plenum chamber 3200 into the respective headgear tube 3340 and allows air exchange between the plenum chamber 3200 and the ambient. When the headgear tube 3340 is pressurized, the AAV in each headgear tube connector 3344 may prevent air exchange between the interior of the plenum chamber 3200 and the ambient and may allow air flow from each headgear tube 3340 into the plenum chamber 3204 for patient breathing.

[0545] In the example shown in Figures 66-1 to 66-3, a common support base is provided for the upper and lower headgear connectors. That is, on each side of the plenum chamber 3200, both the upper headgear strap 3310 (or headgear tube 3340) and the lower headgear strap 3320 connect to a common rigid connector. However, in some examples, the plenum chamber 3200 may have separate upper and lower headgear connectors. Due to tension differences between the upper and lower headgear straps, the formation of the plenum chamber 3200 and the behavior of the seal-forming structure 3100 may be affected. Separate upper and lower headgear connections (i.e., upper and lower headgear connections that can move relative to one another as the cushion flexes) may allow for some flexion about a horizontal axis to achieve a proper fit with a wider range of patients, while allowing this flexion to be adjusted further increases the fit range and adjustability of the patient interface 3000, thereby achieving a more comfortable and effective fit. As discussed in relation to the headgear support portion 3302, the use of separate headgear connectors may help provide at least some of the necessary stiffness to the fascia portion 3210.

[0546] 67-1 through 67-3, a preferred example of a headgear tube 3500 is illustrated in accordance with aspects of the present technology. Manufacture of the headgear tube 3500 may be performed using methods such as those described herein or any other suitable method. It should be understood that the headgear tube 3500 may be used in place of the headgear tube 3340 described herein. Alternatively, the headgear tube 3500 may be configured for use with another patient interface and may alternatively or additionally be sold as a separate component.

[0547] The headgear tube 3500 has a non-circular cross section defined by a patient-contacting portion 3502 and a non-contacting portion 3504 .

[0548] The patient-contacting portion 3502 is formed from at least one layer of material that contacts the patient's skin surface in use, and thus the at least one layer of material is preferably at least one of biocompatible, soft, and flexible.

[0549] The patient-contacting portion 3502 may be multi-layered (e.g., having at least two layers). These additional layer(s) may be one or more of a gas-impermeable layer, a foam layer, and a second fabric layer. For example, FIG. 67-4 is a cross-sectional view of the headgear tube 3340 in a plane substantially perpendicular to the length of the headgear tube 3340. The patient-contacting portion 3502 may be formed from a foam laminate provided with an outer layer of fabric material 3514 that contacts the patient's skin in use, a distal layer 3516 (e.g., a fabric or plastic material), and a layer of foam 3518 between the outer layer 3514 and the distal layer 3516. At least one of the foam layer 3518, the outer layer 3514, and the distal layer 3516 may be gas-impermeable or may be coated with a gas-impermeable material. It should also be noted that the patient contact portion 3502 may be a coated woven material manufactured according to the methods described herein, and therefore includes only a layer of woven material and a layer of gas-impermeable material (e.g., polyurethane (PU) adhesive).

[0550] The non-contact portion 3504 includes at least one layer of woven material 3510 and at least one elastic support element 3506. In the illustrated embodiment, the non-contact portion 3504 includes a plurality of elastic support elements 3506 each spaced apart along the length of the headgear tube 3500.

[0551] These elastic support elements 3506 are formed from an elastic material (preferably using the methods described herein).

[0552] These resilient support elements 3506 are constructed and arranged to withstand or substantially avoid blockage of the headgear tube 3500 during use. For example, these resilient support elements 3506 provide robustness against compression of the non-contacting portion 3504 onto the patient contacting portion 3502 when a force is applied to the headgear tube 3500 (e.g., if the patient steps onto the headgear tube 3500 or if the headgear tube 3500 is otherwise blocked).

[0553] The provision of the resilient support element 3506 can provide benefits in the delivery of respiratory therapy to the patient. For example, the resilient support element 3506 can bend and flex in response to the application of force to the headgear tube 3500. As a result, pressure in the surface of the patient that the headgear tube 3500 contacts can be reduced or eliminated, whereas the use of rigid support elements or rings within the headgear tube 3500 can increase discomfort for the patient.

[0554] Additionally, the resilient support element 3506 may be more cost effective and easier to manufacture than previously available structures for headgear tubes used in conduit headgear.

[0555] As shown in FIG. 67-4 , the non-contact portion may be a multi-layer structure having an outer layer 3510 and at least one other layer of material 3512 attached to the outer layer 3510. The outer layer 3510 may be a woven material manufactured as described herein. In such an embodiment, the inner layer 3512 may be a layer of woven material, a layer of molded or extruded material (e.g., plastic), or a layer of other material (e.g., polyurethane (PU) adhesive). An elastic support element 3506 is provided in the non-contact portion 3504 (e.g., provided on the inner surface of the headgear tube 3500).

[0556] The headgear tube 3500 may be provided with other components (eg, headgear connectors 3246, conduit inlets 3390, or tabs 3342 as with headgear tube 3450).

[0557] Further aspects of headgear tubes 3506 according to the present technology will become more apparent from the discussion of the methods of manufacture described herein.

[0558] 5.3.4 Ventilation In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow the expulsion of exhaled gases (eg, carbon dioxide).

[0559] In certain forms, the vent 3400 is configured to allow continuous vent flow from the interior of the plenum chamber 3200 to atmosphere when the pressure within the plenum chamber is positive relative to atmosphere. The vent 3400 is configured such that the magnitude of the vent flow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining therapeutic pressure within the plenum chamber in use.

[0560] Ventilation section 3400 in one form according to the present technology includes a plurality of holes (eg, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0561] The vent 3400 may be located within the plenum chamber 3200. Alternatively, the vent 3400 is located within a decoupling structure (e.g., a swivel).

[0562] 5.3.5 Decoupling Structures (Singular or Plural) In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0563] 5.3.6 Connection Port The connection port 3600 allows connection to the air circuit 4170 .

[0564] 5.3.7 Forehead support In one form, the patient interface 3000 includes a forehead support 3700 .

[0565] 5.3.8 Anti-asphyxiation valve In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0566] 5.3.9 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows a property of the gas (e.g., pressure) within the plenum chamber 3200 to be directly measured.

[0567] 5.4 RPT Device An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300 (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 can be configured to generate an airflow that is delivered to a patient's airway for treatment of, for example, one or more of the respiratory conditions described anywhere herein.

[0568] In one form, the RPT device 4000 is constructed and arranged to deliver airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0569] The RPT device may have an outer housing 4010. The outer housing 4010 is formed by two portions: an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 may include one or more panel(s) 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0570] The air pressure path of the pneumatic RPT device 4000 may include one or more air circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) and one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0571] One or more of the air path items may be disposed within a removable, unitary structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0572] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In one alternative, the RPT device 4000 can include more than one PCBA 4202.

[0573] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device may include one or more of the following components in an integral unit: In an alternative, one or more of the following components may be arranged as their own separate units.

[0574] 5.4.1.1 Air filter(s) An RPT device in accordance with one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0575] In one form, the inlet air filter 4112 is located at the beginning of the air pressure path upstream of the pressure generator 4140 .

[0576] In one form, an outlet air filter 4114 (eg, an antibacterial agent) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0577] 5.4.1.2 Muffler(s) An RPT device in accordance with one form of the present technology may include a muffler 4120 or multiple mufflers 4120.

[0578] In one form of the present technology, an inlet muffler 4122 is positioned above a pressure generator 4140 in the pneumatic path.

[0579] In one form of the present technology, the outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0580] 5.4.1.3 Pressure generator In one form of the present technology, the pressure generator 4140 that generates the air flow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impellers may be disposed within a volute. The blower may deliver the air supply at a rate of, for example, up to about 120 liters / minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication WO 2013 / 020167.

[0581] The pressure generator 4140 is under the control of the therapy device controller 4240 .

[0582] In other forms, pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows.

[0583] 5.4.1.4 Transducer(s) The transducer may be internal to the RPT device or external to the RPT device. An external transducer may, for example, be located on the air circuit or form part of the air circuit (e.g., a patient interface). An external transducer may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that transmits or moves data RPT device).

[0584] In one form of the present technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal indicative of a characteristic of the airflow (e.g., flow rate, pressure, or temperature at that point in the pneumatic path).

[0585] In one form of the present technology, one or more transducers 4270 may be positioned proximate the patient interface 3000.

[0586] In one form, the signal from the converter 4270 may be filtered (eg, by low-pass, high-pass, or band-pass filtering).

[0587] 5.4.1.5 Anti-spillback valves In one form of the present technology, an anti-spillback valve 4160 may be located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the blower motor 4144).

[0588] 5.4.2 RPT Device Electrical Components 5.4.2.1 Power supply The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.

[0589] In one form of the present technology, the power supply 4210 powers only the RPT device 4000. In another form of the present technology, power is provided from the power supply 4210 to both the RPT device 4000 and the humidifier 5000.

[0590] 5.4.2.2 Input Devices In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow a human to interact with the device. The buttons, switches, or dials may be physical or software devices accessible via a touchscreen. The buttons, switches, or dials may be physically connected to the external housing 4010 in one form, or may communicate wirelessly with a receiver electrically connected to the central controller 4230 in another form.

[0591] In one form, input device 4220 may be constructed and arranged to allow a human to select values ​​and / or menu options.

[0592] 5.4.2.3 Central Controller In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0593] Suitable processors may include x86 INTEL processors, processors based on the ARM® Cortex®-M processor from ARM Holdings (e.g., the S®32 series of microcontrollers from ST Micro Electronics). In certain alternative forms of the present technology, 32-bit RISC CPUs (e.g., the STR9 series microcontrollers from ST Micro Electronics) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of microcontrollers manufactured by Texas Instruments) may also be suitable.

[0594] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0595] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0596] The central controller 4230 may be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220 and the humidifier 5000.

[0597] 5.5 Air Circuit An air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (e.g., the RPT device 4000 and the patient interface 3000).

[0598] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube or air delivery conduit. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single leg may be used.

[0599] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating elements may take the form of a heated wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller (e.g., central controller 4230). One example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety.

[0600] Some existing air delivery conduits for respiratory pressure therapy include corrugated plastic tubing that can feel hard against the skin. Some existing conduits include plastic corrugated tubing formed by a helical plastic support structure and plastic tape. Some tubing with a textile covering may not provide the level of flexibility possible with plastic corrugated tubing, or may not provide sufficient flexibility while remaining crush-resistant.

[0601] A soft and comfortable air delivery conduit may be desirable for patients. For example, patients may find it more comfortable to sleep on an air delivery conduit with a soft, pleasant-to-the-touch exterior. If a patient views the treatment device as comfortable and desirable, their compliance with treatment may be improved. Having a textile surface on the flexible tubing that provides the air flow path between the respiratory pressure treatment device and the patient interface, with high air retention and lightweight construction, provides the necessary function and comfort for treatment, while also providing aesthetics and consumer appeal.

[0602] In an example of the present technology, a lightweight flexible tube is provided that includes a skeleton structure joined to an air-impermeable covering. The covering may include a woven fabric. The skeleton structure may include an array of ring members spaced along the tube. An air-impermeable fabric may surround and be joined to the skeleton structure, thereby forming a hollow interior through which gas can be transported. The air-impermeable covering of the tube may be a laminate material, including a flexible and / or stretchable woven fabric with an air-impermeable film or other layer that allows pressurized air flow without significant surface seepage or leakage. Sealing tape may be used to seal the joint together. At this joint, the laminate overlaps itself, separating the woven fabric layer from the air path. This may result in an air delivery conduit that is effectively sealed, low-cost, easy to manufacture, and attractive to users.

[0603] Figure 7A shows a portion of an exemplary air delivery conduit (or air delivery tube) 4300 of the air circuit 4170. Figure 7B is a cross-sectional view of the air delivery conduit 4300 shown in Figure 7A. In an example of the present technology, the air delivery conduit 4300 is part of or forms part of the air circuit 4170. The air delivery conduit 4300 is configured to provide / carry air flow under pressure from the RPT device 4000 to the patient interface 3000 for delivery of respiratory pressure therapy to the patient.

[0604] The air delivery conduit 4300 includes a reinforcing (or skeleton) structure 4305. The reinforcing structure 4300 provides form to the air delivery conduit 4300 and resists occlusion and / or collapse of the air delivery conduit 4300, for example, under forces that would result in collapse of the air delivery conduit 4300. The air delivery conduit 4300 can be both crush-resistant and flexible. The reinforcing structure 4305 may comprise a single continuous structure or may comprise multiple separate structures. The reinforcing structure 4305 may be elongated. The reinforcing structure 4305 may be flexible, for example, to allow bending of the air delivery conduit 4300. The reinforcing structure 4305 may be configured to resist a crushing force applied to the air delivery conduit 4300. The longitudinal length of the reinforcing structure 4305 and / or the resulting air delivery conduit 4300 may be adjustable.

[0605] 7B, the reinforcement structure 4305 includes a plurality of support structures 4310 (or an arrangement thereof). The support structures 4310 may be ring members, tubular members, hollow members, semi-enclosed members, or any other type of structure that may provide structural support while also forming boundaries for the gas flow path. The distance between the support structures 4310 may be the same along the length of the air delivery conduit 4300 or may vary. Additionally, each support structure 4310 may be a fully enclosed ring, a C-shape (or semi-enclosed member), a rectangle, or any other shape that may maintain an unobstructed flow path through the air delivery conduit 4300.

[0606] 7B, the reinforcement structure 4305 includes multiple separate / individual support structures 4310. These support structures 4310 may be separate from one another rather than connected to one another. Each support structure 4310 is a separate, unitary structure rather than part of a larger, unitary structure. In this example, the support structures 4310 are not connected to one another by covering material 4340. However, these support structures 4310 form the reinforcement structure 4305 of the air delivery conduit 4300. Each support structure 4310 is not joined to adjacent support structures 4310 within the reinforcement structure 4305, but may be joined to adjacent support structures 4310 by covering material 4340.

[0607] In other examples, the reinforcing structure 4305 includes one or more helical rib members or another skeleton structure. In one example, the helical rib may be a heating element (or wire) 4307 that helically surrounds the air delivery conduit 4300 (see FIG. 7C ). Alternatively, the helical rib may be a component separate from the heating element 4307. If not in helical form, the heating element 4307 may extend lengthwise along the wall of the air delivery conduit 4300. It should be understood that the heating element 4307 is optional and may be omitted from the air delivery conduit 4300.

[0608] The air delivery conduit 4300 also includes an air-impermeable covering 4340. The covering 4340 is attached to the reinforcement structure 4305 along the length of the air delivery conduit 4300. The covering 4340 forms a sealed air pathway (or lumen) through which air flow can be conveyed from the air delivery conduit 4300 to the patient interface 3000. In some examples, the covering 4340 includes an outer surface material formed from a woven fabric material. In other examples, the covering 4340 includes a plastic material (e.g., a thermoplastic material) (e.g., a plastic tape surrounding or wrapped around the reinforcement structure 4305). In some examples, the covering 4340 includes a sealing layer laminated or otherwise joined to the outer fabric layer. The covering 4340 may include a woven fabric sheet. The woven fabric sheet is a sheet including a woven fabric material and, optionally, an additional material to make the woven fabric sheet air-impermeable. In some examples, the covering 4340 includes a fabric layer including a fabric material and may also include a sealing layer. As such, the fabric sheet may include a laminate structure. In some examples, one or more layers of the fabric sheet may include a laminate structure. For example, the fabric sheet may include a fabric layer and a sealing layer, where the sealing layer includes a laminate formed from multiple layers (e.g., two layers of material).

[0609] In some examples, the covering 4340 comprises nylon, polyester, spandex, or a combination thereof. In some examples, portions of the air delivery conduit 4300 include a covering 4340 formed from a polymer or elastomeric film, while in other portions of the air delivery conduit 4300, the covering 4340 is formed from a woven material. In some examples, the covering 4340 may include more than one textile material to provide localized features or functions (e.g., including for visual appeal). In some examples, the covering 4340 includes areas that are softer than adjacent areas. In some examples, the covering 4340 includes transparent areas. The transparent areas may allow a user to inspect the inside of the tube for cleanliness.

[0610] The air delivery conduit 4300 may include a layer of woven material and a layer of substantially air-impermeable material (e.g., TPU film). The air-impermeable film may interface with the layer of woven material and the structural ring. In some examples, a sealing layer separates the woven material from the air path at the longitudinal edge of the outer woven layer as the outer woven layer surrounds the reinforcement structure. In some examples, the sealing layer includes a sealing strip, and in other examples, is a sheet laminated to the outer sheet of covering material. In some examples, the covering material 4340 includes a woven fabric and a film laminate (including a layer of woven material and a layer of air-impermeable film, which may be, for example, TPU). The air-impermeable film may interface between the layer of woven material and the support structure 4310 (or other reinforcement structure 4305), creating a barrier to air movement between the woven material and the enclosed air path within the tube. In some examples of the present technology, the air delivery conduit 4300 having a fabric covering 4340 may be coated with silicone or similar material (eg, TPE) to achieve air impermeability.

[0611] The air delivery conduit 4300 may include a short tube attached to a patient interface, or may include a long tube configured to connect a flow generator to a patient interface or to connect a flow generator to a short tube of a patient interface.

[0612] In contrast to the cold and stiff feel of some existing plastic tubes, an air delivery conduit 4300 including an outer surface formed from a woven material may have a soft and warm feel. If a patient's device is comfortable and desirable, the patient's compliance with treatment may be increased. A woven tube may have an appearance more similar to bedding than a medical device. When the surface of a woven tube is rubbed, it may be quieter than a plastic tube. A woven tube may also have a lower weight per unit length than a plastic tube, resulting in lower tube drag. Furthermore, a wider variety of tube cross sections, such as low-profile cross sections (e.g., oval), may be achievable with a woven tube.

[0613] 5.5.1 Support structure 7B, the air delivery conduit 4300 includes a plurality of support structures 4310. The geometry of the support structures 4310 can be optimized for mass production while providing the air delivery conduit 4300 with high flow characteristics and structural strength and a lightweight design. The geometry of the support structures 4310 can also enable a low noise level during use. The geometry of the ring members can be selected to provide a range of pipe cross sections with comparable air flow and impedance.

[0614] In some examples, the support structure 4310 can be a ring member. The support structure 4310 can be a ring or a substantially ring-shaped component. In other examples, the support structure 4310 can have other shapes.

[0615] The support structures 4310 may include a cross-sectional shape and spacing that provides low impedance and low noise levels. Each support structure 4310 may include an outer surface contoured to ensure good adhesion to the covering material 4340 and reduce the risk of rupturing the covering material 4340 during use or manufacturing. The inner surface of each support structure 4310 may be contoured to avoid turbulence, impedance reduction, and / or excess noise. The inner and / or outer contours of the support structure 4310 may include curved sections. The support structures 4310 may include different shapes (e.g., circular, oval) to achieve different overall tube cross sections.

[0616] 8, the support structures 4310 can include an outer surface 4312a. The outer surface 4312a is configured to be attached to the covering 4340, for example, via bonding, gluing, sewing, weaving, or any other attachment method. The contour (e.g., shape) of the outer surface 4312a of each support structure 4310 can be such that it can ensure sufficient adhesion (e.g., minimal or no delamination) to the covering 4340 and reduce the risk of rupture of the covering 4340 during use or manufacturing. The shape or contour of the outer surface can be the outer shape or contour 4312 of the support structure 4310.

[0617] The support structure 4310 may also include an inner surface 4313a opposite the outer surface 4312a. The inner surface 4313a may be directly exposed to the stream of pressurized gas flowing through the air delivery conduit 4300. Alternatively, an air impermeable film or layer may be attached to the inner surface 4313a by, for example, bonding, gluing, sewing, weaving, knitting, or any other attachment method. The inner surface 4313a of each support structure 4310 may be contoured (e.g., shaped) to avoid turbulence, impedance reduction, and reduced noise motion generation. The shape or contour of the inner surface 4313a may be the inner shape or inner contour 4313 of the support structure 4310.

[0618] The outer contour 4312, outer surface 4312a, inner contour 4313 and inner surface 4313a of the support structure 4310 are described in more detail below.

[0619] The support structure 4310 (e.g., a ring member) may include a pair of intermediate surfaces 4314 connecting the outer surface 4312a to the inner surface 4313a. That is, the pair of intermediate surfaces 4314 may extend from the outer surface 4312a to the inner surface 4313a. Additionally, the edges connecting the intermediate surfaces 4314 to the outer surface 4312a may be filleted (e.g., curved, rounded, etc.). Similarly, the edges connecting the intermediate surfaces 4314 to the inner surface 4313a may also be filleted (e.g., curved, rounded, etc.). The support structure 4310 may include a cross-section with rounded corners (e.g., outer rounded corners connecting the outer surface 4312a and the intermediate surface 4314).

[0620] The support structure 4310 can be substantially rigid or semi-rigid. In examples, the support structure 4310 can be formed from polycarbonate, nylon, PEEK, polyester, NORYL, etc., or copolymers or blends (e.g., PETG, polycarbonate ABS, nylon-polyurethane). The support structure 4310 can be formed from a material that is rigid, tough, and / or resilient. In some examples, the support structure 4310 is formed from a plastic or elastomeric material. The support structure 4310 can be formed from a material that has a softening temperature greater than 80°C. The support structure 4310 can be formed from a material that bonds well to air-impermeable materials (e.g., a plastic film (e.g., a thermoplastic polyurethane (TPU) film)). In some examples, the surface of the support structure 4310 can have a finish, molded pattern, structure, and / or other treatment aid to improve adhesion between the support structure 4310 and the air-impermeable material. Such treatments can be, for example, mechanical (eg, roughening / sanding) or surface energy modification (eg, plasma / corona / flame) or chemical (eg, adhesive / primer).

[0621] In some examples of the present technology, the support structure 4310 is formed from an elastomer (e.g., an elastomeric material). In examples, the support structure 4310 may be formed from silicone or TPE. A support structure 4310 formed from an elastomeric material may include sufficient rigidity to withstand a crushing force applied to the air delivery conduit 4300. Furthermore, making the support structure 4310 flexible and resilient may make the air delivery conduit 4300 feel comfortable to the touch. By making the durometer of the support structure 4310 formed from silicone sufficiently high, the support structure 4310 has sufficient rigidity to withstand occlusion of the air delivery conduit 4300 during use. Correspondingly, a support structure 4310 formed from TPE may be hardened such that the rigidity of the support structure 4310 is sufficient to maintain an open air path within the air delivery conduit 4300 against occlusion forces.

[0622] 8 shows the shape of a support structure 4310 of an air delivery conduit 4300 in accordance with an example of the present technology. In this example, the support structure 4310 is formed in a ring shape and may be considered a ring member. The support structure 4310 includes a circular outer contour 4312. By providing the support structure 4310 with a circular outer contour 4312, the air delivery conduit 4300 itself is encouraged to include a circular outer contour or an overall circular cross-section. In this example, the support structure 4310 includes a non-circular inner contour 4313. Specifically, the inner contour 4313 is oval.

[0623] 8 includes a pair of thickened portions 4315. The thickened portions 4315 are located on opposite sides of the support structure 4310. Advantageously, these thickened portions 4315 increase the strength of the support structure 4310 (more than the strength the support structure 4310 would have if it were of uniform thickness).

[0624] The support structure 4310 may be injection molded. The support structure 4310 includes gate locations 4316 and overflow locations 4317 for molding the support structure 4310. Advantageously, the gate locations 4316 and overflow locations 4317 are located in the thickened portion 4315. Locating the gate and overflow locations in the thickened portion 4315 advantageously ensures that any weld line formation during molding is always located in the thickened portion 4315. Because weld lines can be weak points in the support structure 4310, the extra thickness in the thickened portion 4315 provides additional strength to the support structure 4310 at the location of any weld lines.

[0625] In this example, gate location 4316 is provided on face 4314 of support structure 4310. Similarly, overflow location 4317 is provided on face 4314. In some examples, overflow location 4317 and gate location 4316 may be provided on opposite faces of support structure 4310. Providing the overflow and gate locations on the face or interior face of support structure 4310 is advantageous because it eliminates any traces on the exterior surface that are bonded to covering material 4340. Any imperfections on the exterior surface of support structure 4310 could cause fracture of covering material 4340 or its layers.

[0626] FIGS. 16A, 16B, and 17 illustrate alternative gate locations 4316 for forming the support structure 4310. In these examples, the support structure 4310 takes the form of a ring member. In the example of FIG. 16A, the gate location 4316 is located on the outer periphery (e.g., outer surface 4312a) of the support structure 4310. In the example of FIG. 16B, the gate location 4316 is located on the inner periphery (e.g., inner surface 4313a) of the support structure 4310. In both of these examples, material can be used efficiently. Advantageously, in the example of FIG. 16B, any remaining marks or imperfections at the gate location are not on the adhesive surface of the support structure 4310, thereby posing little to no risk of tearing the film or covering material applied to the support structure 4310. In the example of FIG. 17, the gate location 4316 is located on the inner periphery of the support structure 4310 in a continuous arc around the entire periphery of the support structure 4310. In this example, the support structure 4310 may have better concentricity without potential problems due to weld lines, but may have higher material usage and resistivity than the example shown in Figures 16A and 16B.

[0627] In some examples, the support structure 4310 includes an open shape. For example, in some examples, the support structure 4310 is a circular shaped ring member, but does not form a full circle. Such a support structure 4310 may include an opening and may resemble, for example, a circlip, as shown in FIG. 12G. An open support structure 4310 may be advantageous in terms of increased flexibility, which may facilitate assembly with the covering 4340.

[0628] In some examples, the support structures 4310 each include a flat, thin-walled cross section, allowing for a lighter tube weight. In some examples, the support structures 4310 include features or patterns for increased strength and improved adhesion to the covering material 4340.

[0629] FIG. 9 is a cross-sectional view of the support structure 4310 shown in FIG. 8. As shown, the support structure 4310 includes a cross-section at the outer surface 4312a of the support structure 4310 that includes outer circular corners 4318. In this example, the support structure 4310 includes a circular outer edge due to the outer circular corners 4318 in the cross-sectional shape. The outer circular corners 4318 of the support structure 4310 may reduce the risk of the covering material 4340 or its film breaking when applied to the support structure 4310 during use. If the outer periphery of the support structure 4310 included sharp corners, there may be some risk of the film or covering material applied to the support structure 4310 breaking. In this particular example, the support structure 4310 also includes a convex inner surface 4313a. The convex inner surface 4313a may improve the flow characteristics within the air delivery conduit 4300. The cross section of the support structure 4310 may also include an inner circular corner 4319 on the inner surface 4313a of the support structure 4310. In this example, the support structure 4310 includes a circular inner edge provided by the inner circular corner 4319 of its cross-sectional shape.

[0630] The radius of curvature of the outer circular corner 4318 may be greater than the radius of curvature of the inner circular corner 4319. However, the radii of curvature of the outer circular corner 4318 and the inner circular corner 4319 may be the same. Also, the radius of curvature of the inner circular corner 4319 may be greater than the radius of curvature of the outer circular corner 4318. It is contemplated that the outer circular corner 4318 and the inner circular corner 4319 may be chamfered or beveled instead of being curved or filleted. Of course, if desired, either the outer circular corner 4318 or the inner circular corner 4319 may not have a rounded, filleted, chamfered, or beveled edge. Also, each of the outer circular corners 4318 may have a different treatment (i.e., filleted, chamfered, beveled, or no treatment). Correspondingly, each of the inner circular corners 4319 may have a different treatment (ie, filleted, chamfered, beveled, or no treatment).

[0631] The outer circular corners 4318 and inner circular corners 4319 of the support structure 4310 may be areas prone to defects in the air delivery conduit 4300. In particular, leaving the outer circular corners 4318 and inner circular corners 4319 untreated may result in fractures or other damage to the covering material 4340. Treatment of the outer circular corners 4318 and inner circular corners 4319 (e.g., filleting, chamfering, or beveling) may reduce the likelihood of fractures in the covering material 4340.

[0632] 9, the cross section of the support structure 4310 is substantially rectangular (e.g., with right angled sides reserved for rounded corners that may occupy a large portion of the side of the cross section.) In other examples, the cross sectional shape of the support structure 4310 may be, for example, square, trapezoidal, circular, triangular, polygonal, arcuate, semicircular, or any other suitable shape.

[0633] 10 and 11 are cross-sectional views of a support structure 4310 according to other examples of the present technology. In these examples, the support structure 4310 may also be referred to as a ring member. The support structure 4310 shown in FIG. 10 includes a sharp corner. An advantage of this support structure 4310 is that it allows the parting line of a mold tooling configuration in which the support structure 4310 is injection molded to be aligned with one of the sides of the support structure 4310. This may simplify the tooling and reduce the likelihood of parting line marks on the outer surface 4312a of the support structure 4310. The support structure 4310 shown in FIG. 10 includes a sharp corner on one side, allowing the parting line to be located on that side, but includes an outer circular corner 4318 and an inner circular corner 4319 on the other side, reducing the risk of the covering material 4340 or sealing layer 4341 fracturing due to these corners.

[0634] 12A-12I show several different support structures 4310 according to examples of the present technology. It should be understood that the support structures 4310 are not limited to the shapes shown in Figures 12A-12I.

[0635] 12A includes a circular outer contour 4312 and a circular inner contour 4313. In this example, the support structure 4310 is a ring member. In this example, the support structure 4310 has a uniform thickness and cross-sectional shape around the periphery of the support structure 4310.

[0636] 12B includes a circular outer contour 4312 and a circular inner contour 4313, and has a uniform thickness and cross-sectional shape around the periphery of the support structure 4310. In this example, the cross-sectional shape of the support structure 4310 includes rounded corners and a convex inner surface similar to the support structure 4310 shown in FIG.

[0637] 12A and 12B can have uniform and consistent widths at their mid-surfaces. Each of these support structures 4310 can have a uniform thickness and cross-sectional shape. The outer contour 4312 and inner contour 4313 can have the same shape (e.g., circular), and therefore the outer and inner surfaces can also have the same shape.

[0638] As shown, the support structure 4310 of Figure 12B may be thicker than the support structure 4310 of Figure 12A. That is, the intermediate surface 4314 of the support structure 4310 in Figure 12B, which joins the outer and inner surfaces, may be wider than the intermediate surface 4314 of Figure 12A. Additionally, the edges of the outer surface 4312 of the support structure 4310 of Figure 12B may be rounded or filleted.

[0639] 12C-12F may have thickened portions 4315 on opposite sides, which may be achieved by varying the width of the intermediate surface 4314. As a result, the outer surface 4312 and the inner surface 4313 may have different shapes. The thickened configuration may allow for increased crush resistance of the air delivery conduit 4300 and / or reduced risk of blockage due to buckling of the air delivery conduit 4300.

[0640] 12C includes a circular outer contour 4312 and circular corners. The inner contour 4313 of the support structure 4310 is circular on first and second (e.g., top and bottom) opposing sides of the support structure 4310 and includes straight portions on the other two opposing sides of the support structure 4310. The support structure 4310 includes thickened portions 4315 formed by the straight sides of the inner contour 4313. These thickened portions 4315 are provided on opposing sides of the support structure 4310.

[0641] As described in more detail below, for example, with reference to Figures 8 and 9, each support structure 4310 may include an outer surface 4312a, an inner surface 4313a opposite the outer surface 4312a, and a pair of intermediate surfaces 4314 connecting the outer surface 4312a and the inner surface 4313a.

[0642] Each thickened portion 4315 may correspond to a wider portion of an intermediate surface 4314 of the support structure 4310. The intermediate surface 4314 may be wider at the thickened portions 4315 than at other locations on the support structure 4310.

[0643] The support structure 4310 of FIG. 12D includes a circular outer contour 4312 and a non-circular inner contour 4313. In this example, the support structure 4310 may be identified as an oval ring member. The support structure 4310 also includes a pair of thickened portions 4315 on opposite sides of the support structure 4310. In this example, the non-circular inner contour 4313 is oval. The thickened portions 4315 are aligned with the minor axis of the oval inner contour 4313 of the support structure 4310. The thickened portions 4315 are formed by an increase in the spacing between the inner contour 4313 and the outer contour 4312 at the minor axis of the oval inner contour 4313. Additionally, the major axis of the ellipse may extend through the thinnest portion of the support structure 4310 (i.e., the portion of the support structure 4310 where the midsurface 4314 is thinnest).

[0644] The support structure 4310 in FIG. 12E includes an oval outer contour 4312. By providing a plurality (e.g., a series of) support structures 4310 having an oval outer contour, an air delivery conduit 4300 including an oval outer contour or an overall oval cross-section can be formed. An air delivery conduit 4300 including an oval outer shape can have a low-profile appearance and can be comfortable for the patient. In this example, the support structure 4310 includes thickened portions 4315. These thickened portions are aligned with the major axis of the oval outer contour 4312. More typically, these thickened portions are provided on opposite sides of the support structure 4310. The support structure 4310 includes an oval inner contour 4313. In this example, the inner contour 4313 includes a pair of connecting walls at opposing ends with a low curvature (e.g., a large radius of curvature) to create a gap between the ends of the oval inner contour 4313 along the major axis and the outer contour 4312, thereby forming the thickened portion 4315. In other examples, the connecting walls may not include a curvature and may be straight sides of the inner contour 4313.

[0645] The support structure 4310 of FIG. 12F includes an oval outer contour 4312, an oval inner contour 4313, and thickened portions 4315. The thickened portions 4315 are located on opposite sides of the ring member 4315 and are opposed along the major axis of the oval shape of the oval inner contour 4313. In this example, the thickened portions are formed by the spacing between the major axis of the oval inner contour 4313 and the major axis of the oval outer contour 4312. In this example, the ratio between the major axis and the minor axis of the oval inner contour 4313 is less than the ratio between the major axis and the minor axis of the oval outer contour 4312. As a result, the thickness of the support structure 4310 is non-uniform around the circumference of the ring member 4310, with the thickness being greater along the major axes of the oval inner and outer contours.

[0646] Alternatively, the minor axis of the ellipse formed by inner contour 4313 may coincide with the major axis of the ellipse formed by outer contour 4312, and the major axis of the ellipse formed by inner contour 4313 may coincide with the minor axis of the ellipse formed by outer contour 4312. It is also contemplated that the major axis of the ellipse formed by inner contour 4313 may be offset from the major axis of the ellipse formed by outer contour 4312 by any angle between 0 and 90 degrees. Similarly, the minor axis of the ellipse formed by inner contour 4313 may be offset from the minor axis of the ellipse formed by outer contour 4312 by any angle between 0 and 90 degrees.

[0647] In some other examples, the support structure 4310 includes an oval outer contour 4312 and a non-oval inner contour 4312 (e.g., a circular inner contour). In further examples, the support structure 4310 may be D-shaped, trapezoidal, or may include another suitable shape.

[0648] The support structure 3410 of FIG. 12G may be open-shaped (or C-shaped) and include a gap between opposing ends to prevent closure of the loop. It is contemplated that the width of the intermediate surface 4314 may be uniform throughout the support structure 4310. Alternatively, the width of the support structure may vary to create a thickened section 4315. It is contemplated that the gap in the C-shaped support structure 4310 may allow the support structure (and air delivery tube) to be radially compressed (without suffering structural failure that could cause blockage of the air path in the air delivery conduit 4300). This radial compression may also facilitate assembly with the covering material 4340.

[0649] It is contemplated that the outer contour 4312 of the support structure 4310 may be oval and the inner contour 4313 may be non-oval (e.g., circular). FIG. 12H shows a D-shaped support structure 4310. FIG. 81 shows a trapezoidal support structure 4310. With both shapes, a low-profile air delivery conduit 3400 may also be achieved. Of course, the shapes of the outer contour 4312 and inner contour 4313 (or inner and outer surfaces) of the support structure 4310 are not limited to those shown. It should be noted that the outer contour 4312, inner contour 4313 and surfaces of the support structure 4310 may have other suitable shapes.

[0650] In some examples, the distance between adjacent support structures 4310 may be dynamically adjustable. Additionally, each support structure 4310 may be movable proximally to and distally from an adjacent support structure 4310, thereby allowing, for example, the length of the air delivery conduit 4300 to be changed. The longitudinal length of the reinforcement structure 4305 and / or the air delivery conduit 4300 may be adjustable. Also, each support structure 4310 may be movable relative to an adjacent support structure 4310 to a position where the central longitudinal axis of the support structure 4310 is offset from and parallel to the central longitudinal axis of the adjacent support structure 4310.

[0651] The spacing between the support structures 4310 may vary along the length of the air delivery conduit 4300. For example, the support structures 4310 may be spaced further apart in the middle of the air delivery conduit 4300 than at the ends of the air delivery conduit 4300.

[0652] The support structure 4310 may include a uniform width along its periphery, which may facilitate cost-effective manufacturing. In other examples, the air delivery conduit 4300 includes multiple support structures 4310 with different widths, allowing the air delivery conduit 4300 to have different levels of flexibility in bending in different directions.

[0653] An air delivery conduit 4300 according to various examples of the present technology may be formed from a plurality of support structures 4310. These plurality of support structures 4310 are covered or sealed in a covering to form a sealed air pathway.

[0654] 5.5.2 Air-impermeable covering materials 13-15 show different exemplary configurations of the covering 4340. In all of these illustrated configurations, the covering 4340 can comprise a fabric and can be impermeable. FIGS. 13 and 14 show a covering 4340 with a laminate construction. In FIG. 13, the laminate construction can include a fabric layer 4347 comprised of a flexible and / or stretchable woven material (e.g., a woven layer). The laminate material also includes an air-impermeable inner layer (or film) 4348 (e.g., a sealing layer) attached to the fabric layer 4347 (e.g., by bonding, gluing, sewing, weaving, or any other attachment method).

[0655] The woven material may include nylon, polyester, spandex, or any combination thereof. It should be understood that this list of materials is not limiting. Additionally, the woven material may have a knitted, woven, or non-woven structure and may have one-way or two-way stretch properties. To achieve one-way stretch, the woven fabric may be manufactured and oriented so that the stretch direction is parallel to the longitudinal axis of the air delivery conduit 3400. To achieve two-way stretch, the woven fabric may be manufactured and oriented so that a first stretch direction is parallel to the longitudinal axis of the air delivery conduit and a second stretch direction is perpendicular or normal to the longitudinal axis of the air delivery conduit. It is contemplated that in some instances, these stretch properties may be achieved by the material employed (e.g., elastane) or by the construction (e.g., knit pattern).

[0656] The outward-facing side of the woven material (i.e., the side configured to come into contact with the user or other external objects) may be treated to enhance comfort and feel. For example, the woven material may be brushed, silicone-treated, or otherwise treated. The woven material may also be treated to enhance properties such as washability, drying, stain resistance, dust resistance, moisture absorption, etc. Additionally, the inward-facing side of the woven material (i.e., the side facing the interior of the air impermeable inner layer 4348 and air delivery conduit 4300) may be prepared or treated to enhance adhesion and / or bonding with the air impermeable inner layer 4348.

[0657] The use of fabric in the covering 4340 may allow for a lighter weight air delivery conduit 4300, thereby reducing drag associated with the air delivery conduit 4300 (which may cause an instability in the seal between the patient interface and the user's face). For example, the areal density of the fabric may be about 250 g / m2 (GSM) or less. Preferably, the areal density of the fabric may be less than about 180 g / m2 (GSM).

[0658] It is contemplated that the covering 4340 may include more than one type of fabric material to achieve localized features or functions, including visual appeal. For example, the covering 4340 may have a fabric comprising one region of the fabric layer 4347 that is softer than another type of fabric used in an adjacent region, which may be coarser. It is also contemplated that transparent regions in the covering 4340 may allow a user to examine the interior of the air delivery conduit 4300.

[0659] The air impermeable inner layer 4348 may be sandwiched between the fabric material of the fabric layer 4347 and the support structure 4310 of the air delivery conduit 4300. Additionally, the air impermeable inner layer 4348 may be formed from a resilient polymer or elastomer. For example, the air impermeable inner layer 4348 may be a thermoplastic polyurethane (TPU) or a thermoplastic elastomer (TPE). The thickness of the air impermeable inner layer 4348 may be about 0.5 mm or less. Preferably, the thickness of this inner layer may be about 150 microns or less.

[0660] The covering 4340 may be formed at least in part from a woven fabric, although it may be desirable to isolate the woven fabric from the pressurized gas flowing through the air delivery conduit 4300. In particular, it may be desirable to prevent microorganisms or other contaminants from growing or becoming trapped in the fabric and contaminating the pressurized gas flow. Thus, the surface area of ​​the air impermeable inner layer 4348 may be greater than the surface area of ​​the textile material of the textile layer 4347. In this manner, the inner layer 4348 may be sandwiched between the entire textile material of the textile layer 4347 and the inner lumen of the air delivery conduit 4300.

[0661] In the configuration shown in Figure 13, the covering 4340 includes one fabric layer 4347 and one air-impermeable inner layer 4348. In the configuration shown in Figure 14, the covering 4340 includes multiple fabric layers 4347 and multiple air-impermeable inner layers 4348. Providing more fabric layers may increase the softness of the air delivery conduit 4300. Additionally, although only two fabric layers 4347 are shown in Figure 11B, the number of fabric layers 4347 is not necessarily limited to two.

[0662] 15 , the covering 4340 uses only the fabric layer 4347. The air impermeable inner layer 4348 in this configuration is omitted. In configurations without the impermeable inner layer 4348, the fabric layer 4347 may be coated with a material that can make the fabric layer 4347 air impermeable. For example, the fabric layer 4347 may be coated with silicone or a similar material. This configuration may further reduce the bulk of the air delivery conduit 4300 by limiting the number of layers that form the covering 4340.

[0663] In each of the examples shown in Figures 13-15, the fabric layer 4347 may be formed from the outer sheet 4342 or the outer layer 4346 according to any one of the embodiments described herein.

[0664] 5.5.3 End Connectors 7A , each end of the air delivery conduit 4300 may include an end connector 4362, for example, at each end of the air delivery conduit 4300. The end connector 4362 may allow the air delivery conduit 4300 to be connected to a flow generator (RPT device) and a patient interface (in a long tube configuration). The end connector 4362 may also allow the air delivery conduit 4300 to be connected to a patient interface 3000 and another air delivery conduit (in a short tube configuration). It is contemplated that at least one end connector 4362 may be a swivel connection. It is further contemplated that at least one end connector 4362 may be an elbow connection. It is further contemplated that at least one end connector 4362 may be a rigid straight connector. Both end connectors 4362 may have the same structure. Alternatively, the end connectors 4362 may have different structures. For example, the end connector 4362 configured to connect to the inlet of the patient interface may take the form of an elbow, and the end connector configured to connect to the outlet of the RPT device or another air delivery conduit may be a swivel connector or a fixed connection. At least one of the end connectors 4362 may include a venting assembly, an HMX assembly, and / or an anti-asphyxiation assembly.

[0665] 5.5.4 Air Delivery Conduit A plurality of structures 4310 (e.g., ring members as shown in FIG. 8 or other examples of support structures 4310) can be arranged in a linear pattern (e.g., an array) and then sealed with a covering to form the air delivery conduit 4300. The air delivery conduit 4300 can include a plurality of support structures 4310 spaced apart along the length of the air delivery conduit 4300 and an air impermeable covering 4340 attached to the support structures 4310 along the length of the air delivery conduit 4300, which allows air flow to be conveyed through a sealed air path formed by the covering 4340 in use.

[0666] Figure 18 shows multiple support structures 4310 arranged in an array. In the air delivery conduit 4300 shown in Figure 19, a covering material 4340 is added to the support structure 4310 shown in Figure 18. In Figure 19, the air delivery conduit 4300 is forced into a curve.

[0667] Another plurality of support structures 4310, shown in Figure 20, are arranged in an array. In the air delivery conduit 4300 shown in Figure 21, a covering material 4340 is added to the support structure 4310 shown in Figure 20. In Figure 21, the air delivery conduit 4300 is forced into a curve.

[0668] The support structure 4310 shown in the example of Figures 18 to 21 takes the form of a ring member.

[0669] The array of support structures 4310 shown in Figure 18 forming the air delivery conduit 4300 shown in Figure 19 are spaced 2 mm apart in a neutral state (e.g., unstretched and uncompressed), and the array of support structures 4310 shown in Figure 20 forming the air delivery conduit 4300 shown in Figure 21 are spaced 9 mm apart in a neutral state (e.g., unstretched and uncompressed). The support structures 4310 shown in Figure 18 are narrower than the support structures 4310 shown in Figure 20.

[0670] As shown in FIG. 21, the air delivery tube 4300, which has wider ring members spaced a greater distance apart, is more flexible than the air delivery tube 4300 shown in FIG. 19, which has narrower ring members spaced a smaller distance apart.

[0671] The spacing between the support structures 4310 and the width of each support structure 4300 can vary between different examples of the present technology. In some examples, the spacing between the support structures 4310 is relatively large (e.g., about 9 mm) so that a flexible tube (e.g., one with good drapeability) can function better as a decoupling component (especially if the tube is short). In other examples, the spacing between the support structures 4310 is relatively small (e.g., about 2 mm). This is because the shorter spacing allows for less bunching of the covering material 4340 between the ring members 4310 and reduces the likelihood of misalignment between the support structures 4310, thereby reducing the likelihood of tube blockage. In some examples, the spacing between the support structures 4310 is small or medium, but the air delivery conduit 4300 includes a flexible and / or highly stretchable covering material 4340 to impart increased flexibility / drapeability to the air delivery conduit 4300. The spacing between the support structures 4310 and the stretchability of the covering material 4340 may be selected to achieve a predetermined flexibility and / or extensibility of the air delivery conduit 4300 .

[0672] In some examples of the present technology, the air delivery conduit 4300 includes multiple support structures 4310 spaced apart by a distance of 1 mm to 10 mm. In further examples, the spacing is provided by a distance of 2 mm to 6 mm, or by a distance of 2 mm to 3 mm. In some examples, the support structures 4310 of the air delivery conduit 4300 are spaced apart by a distance of less than 6 mm or less than 3 mm. In some examples, the support structures 4310 include ring members having an inner diameter of 11 to 19 mm. In some examples, the inner diameter may be 13 mm to 17 mm or 15 mm. The internal area of ​​each ring member or other support structure 4310 may be 150 mm to 200 mm (e.g., 160 mm to 185 mm). In one example, the internal area of ​​each support structure 4310 is approximately 175 mm. These support structures 4310 may include non-circular shapes (e.g., oval shapes) and include internal areas within a range. This internal surface area allows air to flow through.

[0673] In some examples of the present technology, the air delivery conduit 4300 may include flexibility and / or stretchability that is non-uniform along the length of the tube. In some examples, the air delivery conduit 4300 may include different levels of flexibility and / or stretchability between the tube ends and the center of the tube. For example, the air delivery conduit 4300 may include highly flexible ends and a moderately flexible center. Alternatively, the center of the air delivery conduit 4300 may have higher flexibility and / or stretchability than the ends. In some examples, the support structure 4310 of a particular air delivery conduit 4300 does not include identical properties, geometries, and spacing. In some examples, the air delivery conduit 4300 includes multiple ring members. Some of these multiple ring members include an oval outer profile, and some include a circular outer profile, resulting in a transition from a circular connector that connects to a long tube connected to an RPT device at one end to a lower profile oval connector that connects to a patient interface at the other end. In some examples, in the air delivery conduit 4300, the support structures 4310 are spaced further apart from each other in the central portion 4300 of the air delivery conduit than at the ends of the air delivery conduit 4300, or are spaced further apart at the ends of the air delivery conduit 4300 than at the ends of the air delivery conduit 4300, such that the flexibility of the air delivery conduit 4300 varies along its length.

[0674] The air delivery conduit covering 4340 may be as described above (e.g., the air delivery conduit covering 4340 may be air impermeable and may include an outer surface formed from a woven material). In some examples, the covering 4340 is in the form of a laminate. The covering 4340 may include an outer layer including a woven material bonded to an air impermeable inner layer. In some examples, the air impermeable layer is formed from a polymeric material and may be formed from a thermoplastic material (e.g., thermoplastic polyurethane (TPU)). In other examples, the air impermeable layer may be formed from silicone, a thermoplastic elastomer, or other elastomer.

[0675] 5.5.5 Adding covering material to reinforced structures According to aspects of the present technology, there are multiple ways to apply the covering material 4340 to the reinforcement structure 4305.

[0676] 5.5.5.1 Covering the reinforcement structure with covering material The covering 4340 may wrap around the reinforcement structure 4305 and be bonded to the reinforcement structure 4305 to form a sealed tube including the reinforcement structure. The covering 4340 may form a sealed air path through which air flow can be conveyed by the air delivery conduit 4300 during use. In some examples, the reinforcement structure may include an array of support structures 4310. As mentioned above, the covering 4340 may include a laminate structure in which the outer layer is formed from a woven material and the inner layer is formed from an air-impermeable material (e.g., a TPU film). To prevent the woven material from being exposed to the air path, a sealing layer is provided along the inside of the tube to seal the edges of the woven layer. This ensures a sealed air path, preventing particles from entering the woven fabric and preventing leakage that may occur through the woven fabric layer at all times.

[0677] 22-29 illustrate a method of applying a covering material 4340 to a reinforcement structure 4305 including multiple support structures 4310 in accordance with aspects of the present technology. In this particular example, the support structures 4310 each take the form of a ring member. The method is also applicable to applying a covering material 4340 to another reinforcement structure, such as one or more helical members extending along the length of the tube to be formed.

[0678] In one step, multiple support structures 4310 may be arranged in an array, as shown in Figure 22. As shown in Figure 23, the support structures 4310 may be supported on a mandrel (or rack) 7000. The support structures 4310 may be aligned concentrically with one another, but may also be spaced apart along the length of the mandrel 7000 and the tubing to be formed.

[0679] As shown in FIG. 24 , in a separate step, a sealing layer 4341 may be provided to the support structure 4310 in the form of a sealing strip. In this example, the sealing layer 4341 is a sealing strip. The sealing strip may be attached to the reinforcement structure 4305. In this example, the sealing strip is aligned longitudinally along the length of a series of ring members 4310. The sealing layer 4341 is then bonded to the ring members 4341. In some examples, the sealing layer 4341 comprises a TPU film and is heat-sealable. Tape may be applied to the sealing strip along the reinforcement structure 4305. In other examples, the sealing layer 4341 may be wider than the sealing strip shown in FIG. 24 and may cover a larger portion of the periphery or sides of the support structure 4310.

[0680] In some instances, the sealing layer 4341 includes an adhesive layer as an alternative to a heat-sealable layer. In such instances, the adhesive may be biocompatible and may be fully cured during tube manufacture.

[0681] 25 shows an end view of the mandrel 7000 and the arrangement of the support structure 4310, with the sealing layer 4341 added in the form of a sealing strip. The sealing layer 4341 is bonded to the support structure 4310 and forms an arc shape. The sealing layer 4341 takes the form of a sealing strip and occupies only a portion of the periphery of the support structure 4310 and the air delivery conduit 4300 to be formed. The sealing strip used to provide the sealing layer 4341 may be a sealing tape.

[0682] In other examples, the sealing layer 4341 may occupy a larger portion of the periphery of the air delivery conduit 4300 to be formed. In some examples, the sealing layer 4341 may be formed by wrapping a sealing strip (e.g., in tape form) in a spiral manner around the reinforcement structure 4305 at a small angle, so that the sealing strip overlaps itself and completely seals the reinforcement structure 4305. In a further example, the sealing layer 4341 in the form of a sealing sheet wraps around the entire periphery of the reinforcement structure 4305, so that the sealing sheet completely seals the reinforcement structure 4305.

[0683] An air impermeable covering 4340 may be wrapped around the reinforcement structure 4305 and the sealing layer 4341. In one form, the covering 4340 may be wrapped around the reinforcement structure 4305 and the sealing strip.

[0684] 26 and 27, in a further step, the outer sheet 4342 is wrapped around the reinforcement structure 4305. That is, the outer sheet 4342 may be formed as a sheet and then wrapped around the reinforcement structure 4305 (e.g., as a cylinder) during formation of the covering 4340 for the air delivery conduit 4300. The outer sheet 4342 may not form the outermost layer of the air delivery conduit 4300 or provide an exposed outer surface around the air delivery conduit 4300, but it may not be "outside" to another layer of the air delivery conduit 4300 or "outside" to the reinforcement structure 4305. In some examples, the outer sheet 4342 comprises a woven material and, in such examples, may be identified as a woven sheet.

[0685] The outer sheet 4342 includes a first edge 4342a aligned along the length of the air delivery conduit 4300 to be formed. The first edge 4342a may be aligned across a sealing strip previously applied to the reinforcement structure 4305. The outer sheet 4342 also includes a second edge 4342b opposite the first edge 4342a. The first edge 4342a and the second edge 4342b may be parallel to each other in some examples of the present technology, or may not be parallel in other examples (both may extend along the air delivery conduit 4300). Bonding of the outer sheet 4342 to the sealing layer 4341 and reinforcement structure 4305 may occur during or after wrapping around the reinforcement structure 4305 (e.g., using adhesive) or (e.g., using thermal bonding). In this example, the outer sheet 4342 includes an outer side (facing the periphery of the air delivery conduit 4300, but not necessarily facing the outermost layer) and an inner side (facing the axis of the air delivery conduit 4300). In some examples, the inner side may define at least a portion of an enclosed air path within the air delivery conduit 4300.

[0686] In one example, the outer sheet 4342 comprises a laminate. The outer sheet 4342 can include an outer layer comprising a woven material. The woven material can make the tube comfortable to the touch. The outer sheet 4342 can also include an inner layer comprising an air-impermeable material. The air-impermeable material can be bondable to the sealing layer and / or the reinforcing structure 4305. The air-impermeable material can include a plastic material and can include a thermoplastic material (e.g., TPU). In some examples, the outer and inner layers of the outer sheet 4342 are bonded together by dot adhesive lamination. In another example, they can be bonded by thermal lamination. In some examples, the outer sheet 4342 can include one or more fabric layers 4347 and one or more air-impermeable layers 4348, as described in connection with FIGS. 13-15. In some examples, the outer sheet 4342 or cover material 4340 may include at least one woven layer and at least one non-woven layer (e.g., a film layer disposed on the exterior of the woven layer) disposed on the exterior of the woven layer.

[0687] As shown in Figures 28-30, in a further step, the wrapping of the outer sheet 4342 around the reinforcement structure 4305 and the bonding of the outer sheet 4342, sealing layer 4341, and reinforcement structure 4305 are both completed. The second edge 4342b of the outer sheet 4342 wraps around the reinforcement structure 4305 and passes through the first edge 4342a. After wrapping the outer sheet 4342 around the reinforcement structure 4305, the first edge 4342a and the second edge 4342b extend along the air delivery conduit 4300. The inner side of the outer sheet 4342 adjacent the second edge 4342b is joined to the outer side of the outer sheet 4342 adjacent the first edge 4342a. The second edge 4342b is further bonded onto the outer surface of the outer sheet 4342 adjacent to and spaced from the first edge 4342a, overlapping the outer sheets 4342. The outer sheet 4342 is used to cover more than 360 degrees around the cross section of the tube. Here, the air-impermeable covering material 4340 forms a sealed air passageway and air delivery conduit 4300. A sealing layer 4341 (in this example, a sealing strip) seals the overlapping portion of the outer sheets 4342. By covering the outer sheets 4342 together, a seam can be formed. The sealing layer 4341 (e.g., a sealing strip) can seal the seam. The sealing strip seals along the length of the seam.

[0688] In some examples, the second edge 4342b of the outer sheet 4342 extending along the air delivery conduit 4300 includes a sawtooth profile. The sawtooth profile may be configured to resist delamination of the second edge 4342b of the outer sheet 4342 from the outside of the outer sheet 4342. The second edge 4342b may include a profile such as a crinkle cut, wave, sawtooth, triangular, etc. This type of profile may resist delamination of the outer sheet 4342 from itself. If a portion of the second edge 4342b of an outer sheet 4342 with this type of profile begins to delaminate, this delamination may be less likely to propagate along the edge compared to an outer sheet 4342 that includes a straight second edge 4342b.

[0689] In some examples, a single outer sheet 4342 covers the entire length of the reinforcement structure 4305 (e.g., the entire length of the air delivery conduit 4300). In other examples, multiple outer sheets 4342 form the covering 4340. In one example, a first outer sheet 4342 covers a first half of the reinforcement structure 4305, and a second outer sheet 4342 covers a second half of the reinforcement structure 4305. In such examples, the first edge 4342a and the second edge 4342b of the first and second outer sheets 4342 extend along the air delivery conduit 4300. However, the first edge 4342a of the first outer sheet 4342 and the second outer sheet 4342 need not be collinear with one another. Similarly, the second edge 4342b of the first outer sheet 4342 and the second outer sheet 4342 may not be collinear with one another.

[0690] The adhesive surface of the outer sheet 4342 at or near the second edge 4342b may also be configured to promote good adhesion of the outer sheet 4342 to itself at the second edge 4342b, in some examples of the present technology, the adhesive surface may include depressions, roughening, etc. configured to increase the bonding contact area and bond strength.

[0691] In some examples, the sealing layer 4341 is bonded to the reinforcement structure 4305. The outer sheet 4342 may also be bonded to the sealing layer 4341. The sealing layer 4341 may be heat bonded to the reinforcement structure 4305 and / or the outer sheet 4342, or alternatively may be glued to the reinforcement structure 4305 and / or the outer sheet 4342. The sealing layer 4341 may comprise a heat bondable material (e.g., a thermoplastic material, in some examples TPU).

[0692] An end connector 4362 (e.g., as described with reference to FIG. 7A ) for connecting the air delivery conduit 4300 between the flow generator and the patient interface (either as a short tube configured to connect the patient interface to a long tube or as a long tube configured to connect to a respiratory pressure treatment device) may be attached in a further step. In one example, the air delivery conduit 4300 includes a first end configured to connect to tubing connected to an outlet of the respiratory pressure treatment device 4000 and a second end configured to connect to the patient interface 3000. In another example, the air delivery conduit 4300 includes a first end configured to connect to an outlet of the respiratory pressure treatment device 4000 and a second end configured to connect to the patient interface 3000.

[0693] 30, a first region (or first area) 4343 is provided on the inner side of the outer sheet 4342 near the first edge 4342a. Furthermore, a second region (or first area) 4344 is provided on the inner side of the outer sheet 4342 near the first edge 4342a. The first region 4343 is disposed on a first side of the first edge 4342a, and the second region 4344 is disposed on a second side of the first edge 4342a. That is, the first region 4343 and the second region 4344 are disposed on opposite sides of the first edge 4342a. A sealing layer 4341 (a sealing strip in this example) seals between the first region 4343 and the second region 4344. For example, the sealing layer 4341 may seal the gap between the first portion 4343 and the second portion 4344 where the outer sheets 4342 overlap. The sealing layer 4341 isolates the outer surface of the outer sheet 4342 from the air path within the tube.

[0694] This is particularly advantageous when the outer surface of the outer sheet 4342 is formed from a woven material, because without a seal on the first edge 4342a, the woven material forming the outer surface would be exposed to the air path, allowing for the exchange of gases and / or particles between the woven outer surface and the sealed air path. This may also help prevent or further prevent microorganisms / bacteria that may be present in the woven layer from reaching the air path. The sealing layer 4341 isolates the woven layer from the air path (by bonding to the air-impermeable inner layers of the outer sheets 4342 on either side of the inner overlap of the outer sheets 4342). In this way, the inner surface of the covering 4340 exposed to the air flow in the conduit is formed only by the sealing material (e.g., plastic (e.g., TPU, TPE, silicone)), and no woven layer is exposed to the gas flow in the air delivery conduit 4300.

[0695] In another configuration shown in Figure 40A, the inside of the outer sheet 4342 adjacent the second edge 4342b is bonded to the sealing layer 4341 (a sealing strip in this example, or a sheet or inner tube in other examples) (rather than to the outside of the outer sheet 4342). The second edge 4342b contacts the first edge 4342a to avoid gaps and provide an exterior of the air delivery conduit 4300 made substantially from fabric (without causing thickness doubling due to overlap). The outer layer 4342 wraps around the reinforcement structure, with the second edge 4342b of the outer layer 4342 adjacent to the first edge 4342a. In this example, again, the sealing layer 4341 seals between a first region 4343 on the inside of the outer sheet 4342 on a first side of the first edge 4342a and a second region 4344 on the inside of the outer sheet on a second side of the first edge 4342a. The first region 4343 is the inside region of the outer sheet adjacent the first edge 4342a. In this example, the second region 4344 is the inside region of the outer sheet adjacent the second edge 4342b (adjacent to the first edge 4342a). The sealing layer 4341 seals between the first region 4343 and the second region 4344. The sealing layer 4341 seals across the joint or seam between the first edge 4342a and the second edge 4342b.

[0696] In another configuration shown in FIG. 40B , the first edge 4342 a and the second edge 4342 b are adjacent to one another. In this configuration, they are sewn together. In this example "adjacent" configuration shown in FIGS. 40A and 40B , the inner seam formed by the abutment of the first edge 4342 a and the second edge 4342 b can be aligned with the sealing layer 4350 such that the sealing layer 4350 seals the fabric layer 4341 of the covering 4340 from the pressurized breathing gas in the air passageway. In some examples, both the first edge 4342 a and the second edge 4342 b can be attached to the sealing layer 4350 by, for example, bonding, gluing, sewing, weaving, knitting, or any other attachment method. It is contemplated that the attachment of the first edge 4342 a to the second edge 4342 b can also be by, for example, bonding, gluing, sewing, weaving, knitting, or any other attachment method. It may be desirable to precisely align the first edge 4342 a and the second edge 4342 b so that they are properly adjacent to each other to avoid an unsightly and / or uncomfortable gap between the first edge 4342 a and the second edge 4342 b. Note that the first edge 4342 a and the second edge 4342 b may be serrated as shown in FIG.

[0697] Whether the outer sheet 4342 overlaps itself or only the sealing layer 4341, the outer strip 4354 may be joined to the outside of the outer sheet 4342 along the second edge 4342b of the outer sheet 4342. The outer strip 4354 may be joined along the second edge 4342b of the outer sheet 4342 across the second edge 4342b of the outer sheet 4342. Figure 40C is a cross-sectional view of a portion of the air delivery conduit 4300 including the outer strip 4354. The outer strip 4354 seals the exterior of the joint between the first edge 4342a and the second edge 4342b. The outer strip may comprise a tape, or may comprise a woven material. The outer strips may provide sealing across the second edge 4342b of the outer sheet in an "overlapping" configuration (e.g., the type of configuration shown in FIG. 30) or across both the first edge 4342a and the second edge 4342b in an "adjacent" configuration (e.g., as shown in FIGS. 40B and 40C). The outer strips 4353 may provide additional sealing to the conduit. The outer strips 4354 may be provided to the exterior seams / junctions of the covering 4340 of the air delivery conduit 4300 of any example of the present technology. The outer strips 4354 may also provide a clean looking seam. The color, pattern, and / or structure of the strips may be different from the outer textile layer of the air delivery conduit 4300. The outer strips 4354 along the length of the air delivery conduit 4300 and across the first edge 4342a and / or second edge 4342b of the outer sheet 4342.

[0698] 30, the outer sheet 4342 is joined to the sealing strip 4341, with a first edge 4342a of the outer sheet 4342 positioned along the sealing strip 4341 near a centerline along the sealing strip. The area that may benefit from sealing is the gap between the first edge 4342a and the inner surface of the outer sheet 4342 to which the first edge 4342a is joined, and by centering the first edge 4342a on the sealing strip, the area of ​​the first portion 4343 and second portion 4344 of the inner surface of the outer sheet 4342 is maximized on either side of the first edge 4342a to which the sealing strip 4341 may be joined. The inner side of the outer sheet 4342 near the second edge 4342b is joined to the outer side of the outer sheet 4342 near the first edge 4342a. The second edge 4342b is spaced from the first edge 4342a so that the outer sheet 4342 overlaps itself.

[0699] 28-30, 40A, and 40C, the sealing layer 4341 takes the form of a sealing strip that seals across the interior of the seam of the covering material 4340 to prevent air leakage through the seam. The air-impermeable covering material 4340 has a first edge (e.g., the first edge 4342a of the outer sheet 4342) and a second edge (e.g., the second edge 4342b of the outer sheet 4342). The first edge and second edge each extend along the air delivery conduit 4300. As shown, in each of the illustrated examples, the first edge and the second edge of the covering material 4340 meet or overlap to form a seam. The sealing layer 4341 (or sealing strip in certain examples) seals across the interior of the seam. The sealing strip may seal along and across the seam.

[0700] As shown in Figures 28-30, the covering 4340 is joined to itself at a location adjacent the seam. In each of the examples in Figures 28-30, 40A, and 40C, the covering is joined to the reinforcement structure 4305. In the example shown in Figure 40C, the air delivery conduit 4300 includes an outer strip 4354 joined to the outside of the covering 4340 along the second edge of the covering 4340. The first and second edges of the covering 4340 may be serrated. As shown in Figures 28-30, 40A, and 40C, the inner side of the seam is aligned with the centerline of the sealing strip.

[0701] 31 shows how a sealing layer 4341 and an outer sheet 4342 are overlapped to form a covering 4340 in another example of an air delivery conduit 4300 in accordance with the present technology. The covering 4340 is provided on a reinforcement structure 4305. The reinforcement structure 4305 also includes a plurality of support structures 4310 in this example. The support structures 4310 are ring members in this example, but may have other shapes in other examples of the present technology.

[0702] In this example, the outer sheet 4342 comprises a woven material and therefore may be identified as a woven sheet or woven layer. The sealing layer 4341 is laminated to the outer sheet 4342. Thus, in this example, the covering material 4340 comprises a laminate formed by the woven outer sheet 4342 forming the woven layer and the air-impermeable sealing layer 4341. The outer sheet 4342 includes a first edge 4342a and a second edge 4342b. In this example, the sealing layer 4341 extends from the first edge 4342a to the second edge 4342b, but in other examples, the sealing layer 4341 may be provided on some but not all of the woven layer (depending on the particular configuration of the woven layer).

[0703] In this example, the sealing layer 4341 also includes a sealing flap 4345. In this example, the sealing layer 4341 extends beyond the first edge 4342a of the outer sheet 4342 to form the sealing flap 4345. In this example, the sealing flap 4345 is sealed to another portion of the sealing layer 4341 adjacent the first edge 4342a of the outer layer.

[0704] In this particular example, the sealing flap 4345 covers the first edge 4342a of the textile outer layer 4342. The sealing flap 4345 seals to the portion of the sealing layer 4341 that joins to the outer surface of the outer sheet 4342 adjacent the first edge 4342a of the outer sheet 4342.

[0705] As shown, the sealing flap 4345 is sealed to both the outside of the outer sheet 4342 adjacent the first edge 4342a and the inside of the sealing layer 4341 adjacent the second edge 4342b of the outer sheet 4342. As in the example shown in FIG. 30 , the inside of the outer sheet 4342 includes a first region 4343 on a first side of the first edge 4342a adjacent the first edge 4342a, and also includes a second region 4344 adjacent the first edge 4342a on a second side of the first edge 4342a. In this example, the sealing layer 4341 takes the form of a layer laminated to the outer sheet 4342 and the sealing flap 4345, sealing between the first region 4343 and the second region 4344 on the inside of the outer sheet 4342. As such, the air pathway within the air delivery conduit 4300 is sealed and isolated from the fabric material forming the outer surface of the outer sheet 4342. By sealing the sealing flap 4345 to another portion 4341 of the sealing layer, leakage of flow between a first portion 4343 inside the outer sheet 4342 (e.g., fabric layer) and a second portion 4344 inside the outer sheet 4342 is avoided.

[0706] It should be understood that in some examples of the present technology, the covering material 4340 may include more than two layers. The outer sheet 4342 and the sealing layer 4341 may each include one or more layers. Furthermore, the covering material 4340 may include one or more layers in addition to the outer sheet 4342 and the sealing layer 4341. For example, the sealing flap 4345 may cover the edges of two or more layers and seal another portion 4341 of the sealing layer. The sealing flap 4345 may be a flap portion of the sealing layer 4341.

[0707] After the outer sheet 4342 and sealing layer 4341 have been laminated together, they may be assembled with the reinforcement structure 4305. The sealing flap 4345 is also coated on a first edge 4342a and then assembled with the reinforcement structure 4305 in preparation for coating the outer sheet 4342 and sealing layer 4341 adjacent a second edge 4342b of the outer sheet 4342 onto the sealing flap 4345 and possibly the outer surface of the outer sheet 4342.

[0708] 32 shows another example of an air delivery conduit 4300 according to the present technology. In this example, the sealing layer 4341 includes a layer of air impermeable material laminated to the outer sheet 4342, which layer is formed from a woven material (and may be identified as a woven layer). The sealing layer 4341 also includes a sealing flap 4345. The sealing flap 4345 extends beyond, but does not cover, the first edge 4342a of the outer sheet 4342. In this example, the sealing flap 4345 seals against the inside of the sealing layer 4341 on the second side of the first edge 4342a of the outer sheet 4342. The sealing flap 4345 may be adhered to the reinforcement structure 4305. 30 , the inner side of the outer sheet 4342 includes a first region 4343 on a first side of the first edge 4342a adjacent to the first edge 4342a and a second region 4344 on a second side of the first edge 4342a adjacent to the first edge 4342a. The sealing layer 4341, together with an integral sealing flap 4345, seals between the first region 4343 and the second region 4344. Thus, the sealing flap 4345 is sealed to another region 4341 of the sealing layer, thereby preventing leakage between the first region 4343 on the inner side of the outer sheet 4342 and the second region 4344 on the inner side of the outer sheet 4342. Thus, the woven material of the outer sheet 4342 is isolated from the air flow in the air delivery conduit 4300. An advantage of this example of the technology is that at no point around the periphery of the air delivery conduit 4300 are more than four layers of material stacked together.

[0709] In examples that include a sealing flap 4345, no sealing strip is provided, however in some examples a sealing strip may be provided inside the air delivery conduit 4300, in which case additional sealing is provided at the junction between the sealing flap 4345 and the inner surface of the sealing layer 4341 to which it is bonded.

[0710] 5.5.5.2 Seamless knit sleeves In a further example of the present technology, the covering material 4340 can include a woven sleeve. The woven sleeve can be a knitted sleeve. The knitted sleeve can advantageously include a unitary structure and therefore no seams. The sleeve can be introduced over the reinforcement structure 4305 (e.g., an array of ring members 4310) and then bonded to the reinforcement structure 4305 to form the air delivery conduit 4300. An air impermeable layer (e.g., sealing layer 4341) is bonded to the knitted sleeve by expanding the air impermeable layer within the knitted sleeve.

[0711] In any of the examples of the present technology described herein, the bonding between the woven material and the air-impermeable material may be achieved by one or more of chemical, heat, vibration, ultrasonic bonding processes, or any other suitable process. In some examples, the woven material and the air-impermeable material may be bonded together.

[0712] In the assembly process shown in FIGS. 41 and 42 , a covering 4340 is used that includes an outer layer 4346 in the form of a knitted seamless sleeve. The knitted sleeve may have a seamless tubular structure. It is contemplated that the weaving of the covering 4340 may be performed using circular knitting, 3D knitting, or any other knitting process capable of producing a seamless tubular structure. In this example, the covering 4340 also includes a sealing layer 4341. The sealing layer 4341 may be an air-impermeable inner layer that defines a sealed air passageway through which air can be transported. The sealing layer 4341 may also be formed into a tubular shape and then inserted into the knitted sleeve (outer layer 4346). Once inside the knitted sleeve, the sealing layer 4341 is expanded to cause the outer surface of the sealing layer 4341 to be adjacent to the inner layer of the knitted sleeve. Once expanded, the sealing layer 4341 is attached (e.g., by bonding, gluing, sewing, weaving, or any other attachment method) to the knit sleeve to form the covering 4340. The bond between the outer layer 4346 and the sealing layer 4341 may be achieved by one or more of chemical, heat, vibration, ultrasonic bonding processes, or any other suitable process.

[0713] At the same time, the reinforcement structure 4305 (e.g., an array of support structures 4310) may be placed on the mandrel (or rack) 7000, similar to the "wrap around" method described above. The laminated covering material 4340 is slid onto the reinforcement structure 4305 so that the laminated covering material 4340 surrounds or encapsulates the reinforcement structure 4305. After sliding the laminated covering material 4340 onto the reinforcement structure 4305, the laminated covering material 4340 may be attached to the reinforcement structure 4305 (e.g., by bonding, gluing, sewing, weaving, or any other attachment method).

[0714] 5.5.5.3 Mandrel-assisted inversion 43 shows a covering 4340 in accordance with an example of the present technology. The covering 4340 is configured to be used in conjunction with other components (e.g., reinforcing structure 4305) within an air delivery conduit 4300. A method of manufacturing an air delivery conduit 4300 including the covering 4340 is described in.

[0715] The covering 4340 includes an elongated cylindrical shape. In the state shown in FIG. 43, the covering 4340 includes a first side providing an exterior surface of the covering 4340 and a second side providing an interior surface of the covering 4340. In this example, the covering 4340 includes a first layer on the first side of the covering 4340 and a second layer on the second side of the covering 4340.

[0716] In this example, the first layer of the covering 4340 includes a sealing layer 4341. The second layer of the covering 4340 includes an outer layer 4346 (in the state shown in FIG. 43 , the outer layer 4346 forms the inner surface of the covering 4340 because the covering 4340 has been inverted from its in-use configuration for reasons described below). The sealing layer 4341 and the outer layer 4346 may be similar to the layers described elsewhere in this disclosure. For example, the sealing layer 4341 may include an air-impermeable plastic layer (e.g., a thermoplastic material, TPU, TPE, silicone). The outer layer 4346 may include a fabric layer configured to provide a comfortable and attractive look and feel. In the state shown in FIG. 43 , the sealing layer 4341 is provided on a first side of the covering 4340 to form the outer surface. An outer layer 4346 is provided on a second side of the covering 4340 to form the inner surface.

[0717] One step in a method of forming the air delivery conduit 4300 includes forming the covering 4340 into the configuration shown in FIG. 43. In one example, the method includes forming the covering 4340 from a sheet (by joining opposing edges of the sheet) into an elongated cylindrical shape. The sheet can be a laminate formed by a first layer and a second layer (e.g., sealing layer 4341 and outer layer 4346). In another example, the method includes forming the covering into an elongated cylindrical shape (by forming the second layer into an elongated cylindrical shape and then providing the first layer on the exterior of the second layer). For example, the first layer could be coated, sprayed, or otherwise laminated onto the exterior of the second layer after the second layer has been formed into an elongated cylindrical shape. In one example, the method includes weaving the second layer, for example, by circular weaving or 3D weaving. It should be understood that in some instances of the present technology, more than two layers form the covering 4340 (eg, three, four or more layers).

[0718] Another step in the method includes supporting a reinforcement structure 4305 on a mandrel 7000. In one form of the present technology, the method supports the reinforcement structure 4305 on the mandrel 7000 by compressing the mandrel 7000, mounting the reinforcement structure 4305 onto the mandrel 7000, and expanding the mandrel 7000. FIG. 44 shows a mandrel 7000 in accordance with an example of the present technology. In this example, the mandrel 7000 includes an actuator 7001 and an extension support 7002. Inserting the actuator 7001 into the extension support 7002 expands the mandrel 7000 and retracts the extension support 7002, thereby buckling the mandrel 7000. FIG. 44 shows the mandrel 7000 in a compressed state. In this state, the reinforcement structure 4305 can be mounted on the mandrel 7000 by mounting the reinforcement structure 4305 on the expanding support 7002. As shown in FIG. 45, the reinforcement structure 4305 takes the form of a plurality of support structures 4310, which are supported on the mandrel 7000. In this particular example, the support structures are ring members. After the reinforcement structure 4305 is mounted on the mandrel 7000, the mandrel 7000 is expanded to securely fasten the reinforcement structure 4305. FIG. 46 shows the mandrel 7000 in its expanded state, supporting the reinforcement structure 4305. In this example, the actuator 7001 of the mandrel 7000 is inserted into the expanding support 7002 of the mandrel 7000, causing the expanding support 7002 to expand and clamp the support structure 4310 against the mandrel 7000.

[0719] In another step of the method, the mandrel 7000 and reinforcement structure 4305 are inserted into the interior of the covering 4340 while inverting the covering 4340, with the first side defining the interior surface of the covering 4340 and the second side defining the exterior surface of the covering 4340. That is, in this step of the method, the cylindrical covering 4340 is turned inside out. The originally interior side of the cylindrical shape of the covering 4340 now becomes the exterior, and the originally exterior side now becomes the interior. As such, the covering 4340 in the state shown in FIG. 43 includes a first layer in the form of an air-impermeable sealing layer 4341 on the exterior of the covering 4340, and a second layer in the form of an outer layer 4346 on the interior of the covering 4340. For use in an air delivery conduit 4300, the sealing layer 4341 must form the interior of the covering 4340 to define a sealed air path. It is through this air pathway that air transport can occur with the outer outer layer 4346. As such, the outer layer 4346 can comprise a woven material suitable for use as the outer surface of the air delivery conduit 4300 (due to its soft feel and bedding appearance).

[0720] FIG. 47 shows the mandrel 7000 and reinforcement structure 4305 being inserted into the interior of the covering material 4340. During insertion, the covering material 4340 is inverted so that a first side of the covering material 4340 defines the inner surface of the covering material 4340 and a second side of the covering material 4340 defines the outer...

Claims

1. an air delivery conduit configured to carry a flow of air under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient, the air delivery conduit comprising: a flexible reinforcing structure along the length of the air delivery conduit; an air impermeable covering applied to the reinforcement structure along the length of the air delivery conduit, the covering forming an enclosed air path through which air flow can be conveyed in use, the air impermeable covering comprising: a sealing layer disposed on the flexible reinforcement structure; a sheet covering a periphery of the reinforcing structure, the sheet including a first edge and a second edge, the first edge and the second edge extending along the air delivery conduit, an outer side, and an inner side, respectively, the inner side of the sheet including: a first region on a first side of the first edge adjacent the first edge; and a second portion adjacent the first edge, the second portion being on a second side of the first edge opposite the first side; an inner side of the sheet adjacent the second edge is joined to an outer side of the sheet adjacent the first edge, and the second edge is spaced from the first edge so that the sheet overlaps the second edge; The sealing layer seals between a first portion of the interior of the sheet and a second portion of the interior of the sheet.

2. an air delivery conduit configured to carry a flow of air under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient, the air delivery conduit comprising: a flexible reinforcing structure along the length of the air delivery conduit; a sealing strip attached to the reinforcement structure; an air-impermeable covering covering the reinforcement structure and the sealing strip, wherein the covering defines a sealed air path through which air flow can be conveyed during use, the covering having first and second edges each extending along the air delivery conduit, the first and second edges overlap to form a seam; an inner side of the air impermeable covering material adjacent the second edge is joined to an outer side of the air impermeable covering material adjacent the first edge; The sealing strip seals the entire inside of the seam, thereby preventing air leakage through the seam, an air delivery conduit.

3. The air delivery conduit of claim 1 , wherein an inner side of the sheet adjacent the second edge is bonded to the sealing layer.

4. An air delivery conduit as described in claim 1 or 3, wherein the sealing layer is bonded to the reinforcing structure.

5. An air delivery conduit as described in any one of claims 1, 3, and 4, wherein the sheet is bonded to the sealing layer.

6. An air delivery conduit as described in any one of claims 1 and 3 to 5, wherein the sealing layer comprises a thermoplastic material.

7. An air delivery conduit as described in any one of claims 1 and 3 to 6, wherein the sealing layer is heat-bonded to the reinforcing structure and / or the sheet.

8. 8. The air delivery conduit of any one of claims 1 and 3-7, wherein the air delivery conduit includes an outer strip joined to the outside of the sheet across and along the second edge of the sheet.

9. An air delivery conduit as described in any one of claims 1 and 3 to 8, wherein the sheet includes a laminate.

10. The air delivery conduit of claim 9 , wherein the sheet includes an outer layer comprising a woven material.

11. An air delivery conduit as described in any one of claims 1 and 3 to 10, wherein the sealing layer includes a sealing strip extending along the length of the air delivery conduit.

12. An air delivery conduit as described in claim 11, wherein the sheet is joined to the sealing strip and a first outer edge of the sheet is positioned along the sealing strip adjacent a centerline along the sealing strip.

13. An air delivery conduit as described in any one of claims 1 and 3 to 12, wherein the second edge of the sheet includes a sawtooth profile configured to withstand the second edge of the sheet being peeled away from the outside of the sheet.

14. An air delivery conduit according to any preceding claim, wherein the reinforcing structure comprises a plurality of support structures spaced along the length of the air delivery conduit.

15. 15. The air delivery conduit of any one of claims 1 to 14, wherein the air delivery conduit comprises a first end configured to connect to tubing connected to an outlet of the respiratory pressure treatment device and a second end configured to connect to a patient interface.

16. an air delivery conduit configured to carry a flow of air under pressure from a respiratory pressure therapy device to a patient interface for delivery of respiratory pressure therapy to a patient, the air delivery conduit comprising: a flexible reinforcing structure along the length of the air delivery conduit; an air-impermeable covering provided on the reinforcement structure along the length of the air delivery conduit, the covering providing a sealed air path through which air flow can be conveyed in use, the air-impermeable covering including a fabric layer and a sealing layer laminated to the fabric layer; The covering material covers the periphery of the reinforcement structure and includes a first edge and a second edge, the first edge and the second edge extending along the air delivery conduit, an outer edge and an inner edge, respectively, and the inner side of the fabric layer is a first region on a first side of the first edge adjacent the first edge; and a second portion adjacent the first edge, the second portion being on a second side of the first edge opposite the first side; an inner side of the fabric layer adjacent the second edge is joined to an outer side of the fabric layer adjacent the first edge, and the second edge is spaced apart from the first edge so that the fabric layer overlaps the second edge; A portion of the sealing layer extends beyond the edge of the fabric layer at a first edge of the covering to form a sealing flap, and the sealing flap is sealed to another portion of the sealing layer to seal between a first portion inside the covering and a second portion inside the covering.

17. 17. The air delivery conduit of claim 16, wherein the sealing flap is sealed to both an outer side of a fabric layer adjacent the first edge of the covering and an inner side of the sealing layer.

18. 18. The air delivery conduit of claim 17, wherein the sealing flap is sealed to the inside of the sealing layer on a second side of the first edge of the outer sheet.

19. An air delivery conduit according to any one of claims 16 to 18, wherein the sealing layer is bonded to the reinforcing structure.

20. 20. The air delivery conduit of claim 18 or 19, wherein the delivery conduit includes an outer strip joined to the outside of the fabric sheet across and along the second edge of the fabric layer.

21. 21. The air delivery conduit of any one of claims 18 to 20, wherein the second edge of the covering material includes a serrated profile configured to resist peeling of the second edge of the covering material from an exterior of the covering material.

Images