Air delivery conduit

Abstract

This invention relates to one or more of the screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory diseases. The invention also relates to medical devices or apparatus and their use. [Solution] A method for manufacturing components and devices for providing respiratory pressure therapy, and a component manufactured according to the method. A support structure is provided for the component. In an embodiment, the support structure may be a rigid ring. Alternatively, an elastic material is added to the component to generate an elastic reinforcing element. These devices and components include a conduit for delivering a pressurized gas flow to a patient interface, a positioning and stabilizing structure having a headgear tube together with the support element, and a patient interface including the conduit.

Description

Technical Field

[0001] 1 Cross - reference to related applications For Australian Patent Application No. 2019901704 (filing date: May 20, 2019), Australian Patent Application No. 2019902721 (filing date: July 30, 2019), and Singapore Patent Application No. 1020200432U (filing date: May 11, 2020), the entire contents of these documents are incorporated herein by reference for all purposes.

[0002] 2 Background of the technology 2.1 Field of the technology This technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory - related diseases. This technology also relates to medical devices or apparatuses and their use.

Background Art

[0003] 2.2 Description of related technologies 2.2.1 The human respiratory system and its diseases The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrances to the patient's airways.

[0004] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The primary function of the lungs is gas exchange, taking oxygen from the air into the venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become terminal bronchioles. The bronchi constitute the airways for conduction and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, and this region is called the respiratory region. See the following: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0005] A range of respiratory diseases exist. Certain diseases can be characterized by specific onsets (e.g., apnea, respiratory depression, and hyperventilation).

[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 the onset of closure or obstruction of the upper airway during sleep. This results from a combination of an abnormally small upper airway, normal loss of muscle tone in the tongue region, and normal loss of the soft palate and posterior oropharyngeal wall during sleep. As a result of this condition, respiratory cessation in affected patients typically lasts 30 to 120 seconds, sometimes as many as 200 to 300 times a night. Consequently, excessive daytime sleepiness occurs, which can lead to cardiovascular disease and brain injury. This condition is common, particularly prevalent in overweight middle-aged men, although patients often have no subjective symptoms. See Patent Document 1 (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 the patient's respiratory regulator, characterized by alternating, cyclical increases and decreases in ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. Due to recurrent hypoxia, CSR can be harmful. In some patients, CCR is accompanied by recurrent sleep-wake cycles, which cause severe insomnia, increased sympathetic activity, and increased afterload. See Patent Document 2 (U.S. Patent No. 6,532,959: Berthon-Jones).

[0009] Respiratory failure is a general term for respiratory disorders in which the lungs are unable to produce enough oxygen inhalation or CO2 exhalation to meet the patient's needs. Respiratory failure may encompass some or all of the following conditions:

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

[0011] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia while awake, in the absence of other clearly identifiable causes of hypoventilation. Symptoms include shortness of breath, 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. These include increased resistance to air movement, prolonged expiratory phase of respiration, and reduced normal elasticity in the lungs. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational radiation exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0013] Neuromuscular diseases (NMDs) are a broad term encompassing numerous illnesses and diseases that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage, which can lead to inability to walk, wheelchair confinement, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified into rapidly progressive and slowly progressive types: (i) Rapidly progressive disorders: characterized by muscle damage that worsens over several months and leads to death within several years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: characterized by muscle damage that worsens over several years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increased general weakness, dysphagia, dyspnea at exertion and rest, fatigue, drowsiness, morning headache, and difficulty concentrating and changing mood.

[0014] Chest wall disorders are a group of thoracic deformities that cause dysfunction in the connection between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive disorders and share the potential for long-term excess carbon dioxide respiratory failure. Scoliosis and / or kyphosis can develop into severe respiratory failure. Symptoms of respiratory failure include: exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0015] A range of treatments are used to treat or improve such conditions. Furthermore, otherwise healthy individuals can also take advantage of preventive treatments for respiratory diseases. However, these have several drawbacks.

[0016] 2.2.2 Treatment A variety of therapies (e.g., continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), and invasive ventilation (IV)) are used to treat one or more of the respiratory diseases mentioned above.

[0017] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action involves, for example, pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, allowing CPAP to function as an air splint, thereby preventing upper airway obstruction. Since CPAP treatment for OSA can be voluntary, patients may choose not to adhere to treatment if they notice one or more of the following regarding the device used to deliver the treatment: discomfort, difficulty of use, high cost, or lack of aesthetic appeal.

[0018] Non-invasive ventilation (NIV) provides ventilatory support to the patient through the upper airway to assist with breathing and / or maintain adequate oxygen levels throughout the body by performing some or all of the respiratory function. Ventilation support is provided through a non-invasive patient interface. NIV is used to treat forms of respiratory failure and pulmonary stenosis, 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 can be improved.

[0020] 2.2.3 Treatment System These treatments may be provided by treatment systems or devices. Such systems and devices may also be used for screening, diagnosing, or monitoring diseases without treating them.

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

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

[0023] 2.2.3.1 Patient Interface A patient interface can be used to provide an interface to a breathing apparatus to a wearer, for example by providing an airflow to the airway inlet. The airflow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can form a seal with, for example, the area of the patient's face, thereby promoting gas delivery at a sufficient distributed pressure together with the atmospheric pressure for therapy execution (e.g., at a positive pressure of about 10 cmH2O relative to the atmospheric pressure). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to promote the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O.

[0024] Certain other mask systems may be functionally inappropriate in the art. For example, in the case of a purely decorative mask, it may not be possible to maintain an appropriate pressure. A mask system used for underwater swimming or diving can be configured to protect against water ingress from higher external pressures and not maintain internal air at a pressure higher than the surroundings.

[0025] Certain masks may be clinically unfavorable in the present technology (e.g., when the mask blocks airflow through the nose and only allows airflow through the mouth).

[0026] In certain masks, it may be uncomfortable or impractical in the present technology when the patient has to insert a part of the mask structure into the mouth and create and maintain a seal via the lips.

[0027] Certain masks may be impractical for use during sleep (e.g., when sleeping on the side in bed with the head on a pillow).

[0028] There are several challenges in the design of patient interfaces. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly among individuals. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout the respiratory therapy period.

[0029] Due to these challenges, in some cases of masks, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more of the following reasons: overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of incorrect size is used, it can lead to a decrease in compliance, comfort, and patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic administration mask can withstand their original uses, but in such cases of masks, they can be unacceptably uncomfortable for wearing over a long period (e.g., several hours). Due to such discomfort, the patient's compliance with treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0030] CPAP therapy is extremely effective in the treatment of certain respiratory diseases when the patient agrees to the treatment. If the mask is uncomfortable or difficult to use, the patient may not agree to the treatment. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect the patient's compliance.

[0031] Masks designed for the treatment of sleep apnea may be suitable for other uses because masks for other uses (e.g., pilots) may not be suitable for the treatment of sleep apnea.

[0032] For these reasons, the patient interface for CPAP delivery during sleep forms a distinct field.

[0033] 2.2.3.1.1 Seal-forming structure The patient interface may include a seal-forming structure. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

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

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

[0036] A specific seal-forming structure can be designed for mass production so that one design fits a wide range of different face shapes and sizes, ensuring comfort and effectiveness. To form a seal, one or both the patient's face shape and the mass-produced patient interface seal-forming structure must be adapted to a certain extent, even if there is some mismatch between them.

[0037] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal the patient's face when force is applied to the patient interface while the seal-forming structure is engaged with the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or it may include a molded or formed surface of an elastic sealing element made 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 perimeter of the mask to provide a self-airtight seal against the patient's face when positive pressure is applied inside the mask. Similar to the previously mentioned types of seal-forming structures, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or leakage may occur from the mask. Furthermore, if the shape of the seal-forming structure does not conform to the patient's shape, creases or buckling may occur in the seal-forming portion during use, leading to leakage.

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

[0040] Another form of seal-forming structure may use adhesive to achieve a seal. Some patients may find it inconvenient to constantly attach or remove the adhesive to their face.

[0041] The technology for forming a patient interface seal within a certain range is 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 circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.), which was transferred to Puritan-Bennett Corporation.

[0043] ResMed Limited manufactures the following products using nasal pillows: SWIFT® Nasal Pillow Mask, SWIFT® II Nasal Pillow Mask, SWIFT® LT Nasal Pillow Mask, SWIFT® FX Nasal Pillow Mask, and MIRAGELIBERTY® Full Face Mask. The following patent applications, assigned to ResMed Limited, describe examples of nose pillow masks: International Patent Application WO2004 / 073, 778 (in particular, describing the features of ResMed Limited's SWIFT® nose pillow); U.S. Patent Application 2009 / 0044808 (in particular, describing the features of ResMed Limited's SWIFT® LT nose pillow); International Patent Applications WO2005 / 063, 328 and WO2006 / 130, 903 (in particular, describing the features of ResMed Limited's MIRAGE LIBERTY® full-face mask); International Patent Application WO2009 / 052, 560 (in particular, describing the features of ResMed Limited's SWIFT® FX nose pillow).

[0044] 2.2.3.1.2 Positioning and Stabilization The seal-forming structures of patient interfaces used in positive pressure air therapy are subjected to corresponding forces from the air pressure that can disrupt the seal. Therefore, various techniques are employed to position the seal-forming structures and maintain a seal over the appropriate portion of the face.

[0045] In one technology, adhesive joints are used. For example, see U.S. Patent Application Publication US2010 / 0000534. However, the use of adhesive joints can sometimes cause discomfort.

[0046] In other technologies, one or more straps and / or stabilization harnesses are used. In many such harnesses, one or more of the following apply: poor fit, bulkiness, discomfort, and difficulty of handling.

[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 for the delivery of one or more of the above-mentioned therapies, for example, by activating the device to generate an air delivery flow to the airway interface. This air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0048] Pneumatic generators are well known in a wide range of applications (e.g., industrial-scale ventilation systems). However, pneumatic generators for medical applications have specific requirements that cannot be met by more general pneumatic generators (e.g., reliability, size, and weight requirements for medical devices). In addition, even devices designed for medical treatment may not be free from defects related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

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

[0050] Table of noise output levels of conventional RPT devices (measured using only one sample in CPAP mode at 10 cmH2O using the test method specified in ISO 3744). [Table 1]

[0051] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another embodiment of an RPT device is the ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can provide assistance for invasive and non-invasive independent breathing for a range of patients for the treatment of multiple conditions (e.g., NMD, OHS, and COPD).

[0052] The ResMed Elis Accent Aigu ee® 150 ventilators 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 provide volumetric and pneumatic 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 supply airflow to the patient's airway. In some cases, the airflow may be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface as described above via an air circuit.

[0053] Device designers may be presented with countless options. Because design criteria often conflict, certain design choices may be far removed from convention, or even unavoidable. Furthermore, the comfort and effectiveness of a particular design can be significantly affected by even minor changes in one or more parameters.

[0054] Air circuit Conventional air circuits for respiratory pressure therapy often include corrugated plastic tubes that have a rigid feel against the skin. Such tube materials frequently utilize helical plastic support structures and plastic films.

[0055] 2.2.3.3 Humidifier Delivering airflow without humidification can lead to airway dryness. Using a humidifier with the RPT device and patient interface generates humidifying gas, minimizing nasal mucosal dryness and increasing patient airway comfort. Additionally, in cooler climates, adding warm air to the facial area around the patient interface generally provides greater comfort than cool air.

[0056] While a certain range of artificial humidification devices and systems are publicly known, they do not meet the specific requirements of medical humidifiers.

[0057] Medical humidifiers are typically used to increase the humidity and / or temperature of an airflow relative to the ambient air as needed, when a patient is sleeping or at rest (e.g., in a hospital). Medical humidifiers placed by the bedside may be small in size. They may be configured to humidify and / or heat only the airflow delivered to the patient, and not the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air inhaled by the patient, but these systems also humidify and / or heat the entire room, which can be uncomfortable for the occupant. Furthermore, medical humidifiers may have stricter safety constraints than industrial humidifiers.

[0058] Although numerous medical humidifiers are publicly known, these humidifiers may suffer from one or more defects. Specifically, some medical humidifiers may not humidify properly, or they may be difficult or inconvenient for patients 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" (for example, whether the patient is using their RPT device in accordance with one or more "compliance rules"). For example, a compliance rule for CPAP therapy might require a patient to use their RPT device for at least four hours per night for at least 21 consecutive days out of a 30-day period in order to be considered compliant. To determine patient compliance, an RPT device provider (e.g., a healthcare provider) may manually collect 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 a healthcare provider determines that a patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify third parties that the patient is compliant.

[0060] In patient treatment, there may be other ways in which communication of treatment data to third parties or external systems may be beneficial.

[0061] Existing processes for communicating and managing such data can be costly, time-consuming, and prone to errors.

[0062] 2.2.3.5 Repositioning of the mandible Mandibular repositioning devices (MRDs) or mandibular anterior fixation devices (MADs) are one of the treatment options for sleep apnea and snoring. These are adjustable oral appliances available from dentists or other suppliers that hold the mandible (lower jaw) in an anterior position during sleep. MRDs are removable devices, inserted into the patient's mouth before sleep and removed after sleep. Therefore, MRDs are not designed for continuous wear. MRDs may be custom-made or manufactured in standard forms and include an occlusal impression site designed to fit the patient's teeth. This mechanical projection from the mandible expands the space behind the tongue, adds tension to the pharyngeal wall, reduces airway collapse, and reduces palatal vibration.

[0063] In certain embodiments, the mandibular anterior fixation device may include an upper splint intended to engage with or interlock with teeth on the maxilla or maxilla, and a lower splint intended to engage with or interlock with teeth on the maxilla or mandible. The upper and lower splints are connected laterally to each other via a pair of connecting rods. This pair of connecting rods is fixed symmetrically on the upper and lower splints.

[0064] In this design, the length of the connecting rod is selected so that the mandible is held in an anterior position when the MRD is placed in the patient's oral cavity. The length of the connecting rod can be adjusted to change the level of mandibular protrusion. The dentist can determine the level of protrusion to match the mandible, and the length of the connecting rod is determined accordingly.

[0065] Some MRDs are configured to push the mandible forward relative to the maxilla, while others, like other MADs such as the ResMed Narval CC® MRD, are designed to hold the mandible in an anterior position. This device also reduces or minimizes dental and temporal / mandibular joint (TMJ) side effects. Therefore, the device is configured to minimize or avoid any movement of one or more teeth.

[0066] 2.2.3.6 Ventilation Technology Some forms of treatment systems may include vents to expel exhaled carbon dioxide. These vents may allow gas to flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings).

[0067] These vents may include orifices, through which gas can flow when the mask is in use. In the case of numerous such vents, noise is generated. In other cases, they may become blocked during use, resulting in insufficient airflow. In some cases, the sleep of the patient 1000 and the person sharing the bed 1100 may be disturbed, for example, due to noise or concentrated airflow.

[0068] ResMed Limited has developed several improved mask ventilation technologies. See below: International Patent Application Publication WO1998 / 034,665; International Patent Application Publication WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication US2009 / 0050156; U.S. Patent Application Publication 2009 / 0044808.

[0069] Table of noise levels for conventional masks (ISO 17510-2:2007, 10 cmH2O pressure at 1 m) [Table 2]

[0070] (*Only one sample was measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744.) 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 [Overview of the Initiative] [Problems that the invention aims to solve]

[0072] 3. A brief explanation of the technology This technology relates to the provision of medical devices used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases, which have one or more of the following advantages: improved comfort, cost, effectiveness, ease of use, and manufacturability. [Means for solving the problem]

[0073] A first aspect of this technology relates to a device used for screening, diagnosing, monitoring, improving, treating or preventing respiratory diseases.

[0074] Another aspect of this technology relates to a method used in screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0075] One aspect of a particular form of this technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0076] Another aspect of a particular form of this technology is to provide improved manufacturing methods and techniques for devices and components used in screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0077] Another aspect of this technology is to provide a device used in screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, which may facilitate the use of improved manufacturing methods and techniques.

[0078] One aspect of this technology relates to air delivery conduits that offer greater comfort and visual appeal.

[0079] Another aspect of this technology relates to an air delivery conduit including a fabric.

[0080] Another aspect of this technology relates to a quiet, inconspicuous, and / or patient-friendly air delivery conduit. This air delivery conduit may include a fabric.

[0081] Another aspect of this technology relates to an air delivery conduit configured to be elongated or in contact. The air delivery conduit may be configured to be elongated or in contact without twisting.

[0082] Another aspect of this technology relates to an air delivery conduit containing an airtight fabric.

[0083] Another aspect of this technology includes an air delivery conduit having an outer surface formed of a fabric and an inner surface formed of an air-impermeable material.

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

[0085] Another aspect of this technology includes an air delivery conduit laminate containing a fabric.

[0086] Another aspect of this technology includes an air delivery conduit containing an exterior material, and a sealing layer configured to seal the exterior material and the exterior material.

[0087] Another embodiment of this technology includes an air delivery conduit that is less invasive and, with the use of fabric, is more appealing to patients, thus leading to improved treatment compliance.

[0088] An air delivery conduit included in another aspect of this technology is lightweight and / or imposes low tube drag on the patient interface.

[0089] An air delivery conduit included in another aspect of this technology is in the form of a short tube of a patient interface, which is configured to connect to a hose connected to a respiratory pressure therapy device.

[0090] An air delivery conduit included in another aspect of this technology takes the form of a long tube and is configured to connect directly to a respiratory therapy device at a first end and directly to a patient interface at a second end.

[0091] A patient interface included in another aspect of this technology includes, by example, an air delivery tube in the form of a short tube.

[0092] Another aspect of this technology relates to a patient interface assembly. This patient interface assembly includes a patient interface configured to engage tightly with a patient's face and an air delivery tube connectable to the patient interface. The air delivery tube may include a woven material.

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

[0094] An air delivery conduit included in another aspect of the present technology includes an outer layer formed from a fabric comprising one or more first parts and one or more second parts. By heat-treating the outer layer, a change in the properties of the second parts can be induced.

[0095] An air delivery conduit included in another aspect of this technology includes an outer layer formed from a fabric containing a cured fiber mesh. The cured fiber mesh may be cured by a curing process. The cured fiber mesh may be affected by heat treatment. The cured fiber mesh may contain fibers formed from a thermoplastic or thermosetting material.

[0096] An air delivery conduit included in another aspect of the present technology includes an outer layer formed from a fabric, comprising a first portion having a first rigidity and a second portion having a second rigidity greater than the first rigidity. The outer layer may include a plurality of first portions and a plurality of second portions arranged alternately along the length of the outer layer.

[0097] Another aspect of the technology includes an air delivery conduit comprising an outer layer formed from a knitted fabric, the knitted fabric comprising one or more portions at least partially woven from a heat-activated yarn. The heat-activated yarn may include fibers at least partially dissolved relative to the surrounding fibers. The heat-activated yarn may include fibers at least partially cured.

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

[0099] An air delivery conduit included in another aspect of the present technology is configured to deliver an airflow under pressure from a respiratory pressure therapy device to a patient interface for the provision of respiratory pressure therapy to a patient, and the air delivery conduit includes: Flexible reinforcing structures provided along the length of the air delivery conduit; An air-impermeable cover material is provided on the reinforcing structure along the length of the air delivery conduit, and the cover material forms a sealed air path, through which airflow can be transported during use, and the air-impermeable cover material is A sealing layer provided in a flexible reinforcing structure; A sheet covering the periphery of a 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, the outside and the inside, respectively, the inside of the sheet, A first portion on the first side of the first edge in the vicinity of the first edge; and A second portion adjacent to the first edge, the second portion provided on the second side of the first edge opposite the first side; The sealing layer seals the space between the first inner portion of the sheet and the second inner portion of the sheet.

[0100] In the example: (a) the inner side of the sheet near the second edge is joined to the sealing layer; (b) the inner side of the sheet near the second edge is joined to the outer side of the sheet near the first edge; (c) the sealing layer is joined to the reinforcing structure; (d) the sheet is joined 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 heat-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 joined to the outside of the woven sheet across and along the second edge of the sheet; (j) the outer strip comprises a flexible tape; and / or (k) the outer strip comprises a woven material.

[0101] In the example: (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 thermoplastic polyurethane; (e) the outer and inner layers are joined together by 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 the first edge of the sheet is positioned along the sealing strip near the center line along the sealing strip; (h) the inner side of the sheet near the second edge is joined to the outer side of the sheet near the first edge, and the second edge is positioned spaced apart from the first edge so that the sheet overlaps with the second edge; and / or (i) the second edge of the sheet comprises a serrated outline configured to withstand the second edge of the sheet being peeled away from the outside of the sheet.

[0102] In the example: (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 a tubular material connected to the outlet of a respiratory pressure therapy 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 the outlet of a respiratory pressure therapy device and a second end configured to connect to a patient interface.

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

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

[0105] In the example, the sealing layer is joined to the reinforcing structure.

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

[0107] In the example, the sealing layer includes a thermoplastic material.

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

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

[0110] In the example: the sheet includes lamination.

[0111] In the example: The sheet includes an outer layer containing a woven material.

[0112] In the example: The sealing layer includes a sealing strip that extends along the length of the air delivery conduit.

[0113] In the example, the sheet is joined to the sealing strip, and the first edge of the outer sheet is positioned along the sealing strip, near the center line along the sealing strip.

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

[0115] In the example, the second edge of the sheet includes a serrated outline configured to withstand peeling of the second edge of the sheet away from the outside of the sheet.

[0116] In the example, the reinforcing structure includes multiple support structures arranged at intervals along the length of the air delivery conduit.

[0117] In an example, the air delivery conduit includes a first end configured to connect to a tubular material connected to the outlet of a respiratory pressure therapy device, and a second end configured to connect to a patient interface. An air delivery conduit included in another aspect of the Art is configured to deliver an airflow under pressure from a respiratory pressure therapy device to a patient interface for the provision of respiratory pressure therapy to a patient, and the air delivery conduit includes: Flexible reinforcing structures are provided along the length of the air delivery conduit; An air-impermeable cover material provided on a reinforcing structure along the length of an air delivery conduit, wherein airflow can be transported during use through a sealed air path formed by the cover material, and the air-impermeable cover material includes a woven fabric layer and a sealing layer laminated to the woven fabric layer; The cover material covers the reinforcing 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 conduits, the outside and inside respectively, and the inside of the fabric layer includes: A first portion on the first side of the first edge in the vicinity of the first edge; and A second portion adjacent to the first edge, the second portion provided on the second side of the first edge opposite the first side; A portion of the sealing layer extends beyond the first edge of the fabric layer to form a sealing flap, which seals to another portion of the sealing layer, thereby preventing leakage flow between the first portion inside the fabric layer and the second portion inside the fabric layer.

[0118] In the example: (a) the sealing flap is sealed to both the outside of the fabric layer and the inside of the sealing layer in the vicinity of the first edge of the fabric 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 the example: (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 cover material across and along the second edge of the cover material; (g) the outer strip comprises a flexible tape; and / or (h) the outer strip comprises a woven material.

[0120] In the example: (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 joined together by dot adhesive lamination; (d) the inside of the neighboring cover material of the second edge is joined to the outside of the neighboring cover material of the first edge, and the second edge is positioned spaced apart from the first edge so that the cover material overlaps with the second edge; and / or (e) the second edge of the cover material comprises a serrated outline configured to withstand the second edge of the cover material being peeled away from the outside of the cover material.

[0121] In the example: (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 a tubular material connected to the outlet of a respiratory pressure therapy 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 the outlet of a respiratory pressure therapy device and a second end configured to connect to a patient interface.

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

[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 joined to the reinforcing structure.

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

[0126] In the example, the sealing layer includes a thermoplastic material.

[0127] In the example: the inside of the cover material near the second edge is joined to the outside of the cover material near the first edge, and the second edge is positioned at a distance from the first edge, so the cover material overlaps with the second edge.

[0128] In the example, the second edge of the cover material includes a serrated outline configured to withstand peeling of the second edge of the cover material from the outside of the cover material.

[0129] In the example, the reinforcing structure includes multiple support structures arranged at intervals along the length of the air delivery conduit.

[0130] In the example, the air delivery conduit includes a first end configured to connect to a tubular material connected to the outlet of a respiratory pressure therapy device, and a second end configured to connect to a patient interface.

[0131] An air delivery conduit included in another aspect of the present technology is configured to deliver an airflow under pressure from a respiratory pressure therapy device to a patient interface for the provision of respiratory pressure therapy to a patient, and the air delivery conduit includes: Flexible reinforcing structures provided along the length of the air delivery conduit; Sealing strips added to the reinforcing structure; An air-impermeable woven fabric cover material for covering a reinforcing structure and sealing strip, wherein airflow can be transported during use through a sealed air path formed by the cover material, and the cover material has a first edge and a second edge, respectively, extending along an air delivery conduit, the first edge and the second edge meeting or overlapping to form a seam; The sealing strip prevents air leakage through the seam by sealing the entire inside portion of the seam.

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

[0133] In the example, the cover material itself is joined at a location near the seam.

[0134] In the example, the cover material is joined to the reinforcing structure.

[0135] In the example: the cover material is joined to the sealing strip.

[0136] In the example, the cover material includes a woven fabric, and the sealing strip includes a thermoplastic material.

[0137] In the example, the conduit further includes an outer strip joined to the outside of the cover material along the second edge of the cover material.

[0138] In the example, the first edge and / or second edge of the cover material are serrated.

[0139] In the example, the cover material has a laminate structure.

[0140] In the example, the cover material includes an air-impermeable inner layer and an outer woven fabric layer.

[0141] In the example: the air-impermeable inner layer includes a thermoplastic material.

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

[0143] In the example, the reinforcing structure includes multiple support structures arranged at intervals along the length of the air delivery conduit.

[0144] In the example, the air delivery conduit includes a first end configured to connect to a tubular material connected to the outlet of a respiratory pressure therapy device, and a second end configured to connect to a patient interface.

[0145] An air delivery conduit included in another aspect of the present technology is configured to deliver an airflow under pressure from a respiratory pressure therapy device to a patient interface for the provision of respiratory pressure therapy to a patient, and the air delivery conduit includes: A flexible reinforcing structure including multiple support structures arranged at intervals along the length of the air delivery conduit; An air-impermeable cover material provided on a support structure along the length of an air delivery conduit, wherein airflow can be transported during use through the sealed air path formed by the cover material; 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 an outer circular corner connecting the outer surface and the intermediate surfaces.

[0146] In the example: (a) the cross-section of each support structure includes an inner circular corner connecting the inner and intermediate surfaces; (b) the radius of the outer circular corner of each support structure is greater than that of 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 the example: (a) Each support structure is formed as a ring member; (b) Each support structure includes a circular outer shape and a non-circular inner shape; (c) Each support structure includes a pair of thickened sections on opposing sides of the support structure; (d) Each support structure includes an oval inner shape; (e) Each support structure includes an oval outer shape; (f) Each support structure includes an oval inner shape; (g) The inner shape of each support structure includes a pair of straight sides on opposing sides of the support structure; and / or (h) A pair of straight sides are opposite along the major axis of the oval inner shape.

[0148] In the example: (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 the example: (a) an air-impermeable cover material includes an outer surface formed from a woven material; (b) an air delivery conduit includes a first end configured to connect to a tubular material connected to the outlet of a respiratory pressure therapy device and a second end configured to connect to a patient interface, and / or (c) an air delivery conduit includes a first end configured to connect to the outlet of a respiratory pressure therapy 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 that of the inner circular corner.

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

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

[0154] In the example: The support structure(s) include a pair of thickened sections on opposing sides of the support structure.

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

[0156] In the example, each ring member includes an oval outer shape.

[0157] In the example, each ring member includes a circular outer shape and a non-circular inner shape.

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

[0159] In the example: The inner outer shape of each ring member includes a pair of straight sides on the opposing sides of the ring member.

[0160] In the example, a pair of straight sides face each other along the major axis of the inner outer shape of the oval.

[0161] An air delivery conduit included in another aspect of the present technology is configured to deliver an airflow under pressure from a respiratory pressure therapy device to a patient interface for the provision of respiratory pressure therapy to a patient, and the air delivery conduit includes: A flexible reinforcing structure including multiple support structures arranged at intervals along the length of the air delivery conduit; An air-impermeable cover material provided on a support structure along the length of an air delivery conduit, wherein airflow can be transported during use through the sealed air path formed by the cover material; Each support structure includes a pair of thickened sections on opposing sides of the support structure.

[0162] In the example: (a) Each support structure includes a circular outer shape and a non-circular inner shape; (b) Each support structure includes an oval inner shape; (c) A pair of thickened sections face each other along the minor axis of the oval inner shape; (d) Each support structure includes an oval outer shape; (e) Each support structure includes an oval inner shape; (f) Thickened sections face each other along the major axis of the oval inner shape; 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 surface and the inner surface, with each thickened section of the support structure corresponding to the wide portion of the intermediate surface of the support structure.

[0163] In the 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 that of the inner circular corner; and / or (d) Each support structure includes a convex inner surface.

[0164] In the example: (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 the example: (a) the air-impermeable cover material comprises a woven material; (b) the air-impermeable cover material comprises an outer surface formed from the woven material; (c) the air delivery conduit comprises a first end configured to connect to a tubular material connected to the outlet of a respiratory pressure therapy 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 the outlet of a respiratory pressure therapy device and a second end configured to connect to a patient interface.

[0166] In the example, each support structure includes a circular outer shape and a non-circular inner shape.

[0167] In the example: Each support structure includes an oval inner shape.

[0168] In the example, the pair of thickened sections face each other along the minor axis of the inner outer shape of the oval.

[0169] In the example: Each support structure includes an oval outer shape.

[0170] In the example: Each support structure includes an oval inner shape.

[0171] In the example, the thickened sections are aligned along the long axis of the inner and outer contours of the oval shape.

[0172] In the 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, with the thickened portion of each support structure corresponding to the wider portion of the intermediate surface of the support structure.

[0173] In the example: Each support structure includes a cross-section with an outer circular corner connecting the outer surface and the 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 that of the inner circular corner.

[0176] In the example: Each support structure includes a convex inner surface.

[0177] An air delivery conduit included in another aspect of the present technology is configured to deliver an airflow under pressure from a respiratory pressure therapy device to a patient interface for the provision of respiratory pressure therapy to a patient, and the air delivery conduit includes: Flexible reinforcing structures provided along the length of the air delivery conduit; A cover material attached to a reinforcing structure along the length of an air delivery conduit, wherein the cover material includes a woven material; A sealing layer that forms a sealed air passage, enabling the transport of airflow during use through the sealed air passage; The reinforcing structure is provided between the cover material and the sealing layer.

[0178] In the example: (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 shape of a ring member. (c) The reinforcing structure includes one or more helical members; (d) The sealing layer is formed from a polymer material; (e) The sealing layer is formed from a thermoplastic material; (f) The thermoplastic material includes 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 is (n) a sealing layer is heat-bonded to a reinforcing structure and / or a cover material; (o) a sealing layer is bonded to a reinforcing structure and / or a cover material; (p) an air delivery conduit includes a first end configured to connect to a tubular material connected to the outlet of a respiratory pressure therapy device and a second end configured to connect to a patient interface, and / or (q) an air delivery conduit includes a first end configured to connect to the outlet of a respiratory pressure therapy device and a second end configured to connect to a patient interface.

[0179] In the example: (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 withstand hydrolysis; (d) the inner film layer is antimicrobial; (e) the inner film layer comprises ether-type TPU; and / or (f) the softening temperature of the outer film layer is lower than that of the inner film layer.

[0180] In the example, the reinforcing structure includes multiple support structures arranged at intervals along the length of the air delivery conduit.

[0181] In the example, each support structure takes the shape of a ring member.

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

[0183] In the example: The woven material includes a knitted structure.

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

[0185] In this example, the sealing layer is heat-bonded to the cover material.

[0186] In the example, the inner film layer is constructed to withstand hydrolysis.

[0187] In this example: the inner film layer is antibacterial.

[0188] In the example: the inner film layer includes 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 this technology includes a method for manufacturing an air delivery conduit. This air delivery conduit is configured to deliver an airflow under pressure from a respiratory pressure therapy device to a patient interface for the provision of respiratory pressure therapy to a patient. The method includes: Adding a cover material to the outside of a slender, flexible reinforcing structure; Inserting a sealing layer into the interior of a reinforcing structure, wherein the sealing layer includes an elongated cylindrical shape when inserted into the interior of the reinforcing structure; and The sealing layer is bonded to the cover material, and airflow can be transported during use through the sealed air path formed by the sealing.

[0191] In the example: (a) the method comprises supporting the reinforcing structure on a mandrel and sliding the cover material on the reinforcing structure; (b) the method comprises supporting the reinforcing structure on a mandrel and covering the periphery of the reinforcing structure with the cover material; and / or (c) the method comprises holding the cover material in an open state and inserting the reinforcing structure into the cover material.

[0192] In the example: (a) The method includes preheating the cover material; (b) The method includes inserting the sealing layer after preheating the cover material by blowing hot air; (c) The method includes blowing hot air from a mandrel inserted into the cover material; (d) The method includes blowing hot air from outside the cover material through the cover material; (e) The method includes supporting the sealing layer on the mandrel and inserting the mandrel and the sealing layer inside the reinforcing structure; (f) The method includes inflating the sealing layer by blowing hot air into the interior of the sealing layer to bond it to the cover material; (g) The method includes heat bonding the sealing layer to the cover material; (h) The method includes bonding the sealing layer to the cover material; (i) The mandrel has a low friction surface; and / or (j) The method includes supporting the sealing layer on a balloon of the mandrel and inflating the balloon with hot air to expand the sealing layer and bond the sealing layer to the cover material.

[0193] In further examples: (a) the cover material includes a woven material; (b) the reinforcing structure includes a plurality of support structures spaced apart along the length of the air delivery conduit; (c) the reinforcing structure includes one or more helical members; (d) the sealing layer is formed from a polymer material; (e) the sealing layer is formed from a thermoplastic material; (f) the thermoplastic material includes 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; and / or (m) the woven material includes a non-woven structure; and / or (n) each support structure takes 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 withstand hydrolysis; (d) the inner film layer is antimicrobial; (e) the inner film layer comprises ether-type TPU; and / or (f) the softening temperature of the outer film layer is lower than that of the inner film layer.

[0195] In the example, the cover material includes a first layer on a first side of the cover material and a second layer on a second side of the cover material, the first layer including an air-impermeable sealing layer.

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

[0197] In the example, the method includes forming the cover material into an elongated cylindrical shape by forming the second layer into an elongated cylindrical shape and then providing the first layer outside the second layer.

[0198] In the example: The method involves weaving a second layer. In the example, the method includes inverting the cover material by inward rotation of the cover material and moving it on the mandrel toward the central axis of the cover material.

[0199] In the example, the method includes supporting the reinforcing structure on the mandrel by folding the mandrel, attaching the reinforcing structure on the mandrel, and extending the mandrel.

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

[0201] In the example, the method includes bonding the reinforcing structure to the cover material.

[0202] In the example, the method includes bonding or welding the reinforcing structure to the cover material by either thermal bonding or ultrasonic welding.

[0203] Another aspect of this technology includes a method for manufacturing an air delivery conduit. This air delivery conduit is configured to deliver an airflow under pressure from a respiratory pressure therapy device to a patient interface for the provision of respiratory pressure therapy to a patient. The method includes: To form a cover material for an air delivery conduit, the cover material having an elongated cylindrical shape and including a first side portion that provides the outer surface of the cover material and a second side portion that provides the inner surface of the cover material; Supporting a slender, flexible reinforcing structure on a mandrel; By inserting the mandrel and reinforcing structure into the cover material with the cover material inverted, the inner surface of the cover material is obtained from the first side and the outer surface of the cover material is obtained from the second side; Remove the mandrel from the cover material, leaving the reinforcing structure inside the cover material.

[0204] In the example: (a) The cover material comprises a first layer on a first side of the cover material and a second layer on a second side of the cover material, the first layer comprising an air-impermeable sealing layer; (b) The method comprises forming the cover material from a sheet into an elongated cylindrical shape by joining opposing edges of the sheet, the sheet being a laminate formed of the first and second layers; (c) The method comprises forming the cover material into an elongated cylindrical shape by providing the first layer outside the second layer after forming the second layer into an elongated cylindrical shape; (d) The method comprises weaving the second layer; (e) The method comprises (f) The method includes inverting the cover material by inward rotation of the bar material and moving it onto the mandrel toward the central axis of the cover material; (g) The method includes supporting the reinforcing structure on the mandrel by folding the mandrel, attaching the reinforcing structure to the mandrel, and expanding the mandrel; (h) The method includes folding the mandrel after inserting the mandrel and the reinforcing structure into the cover material to release the reinforcing structure; (i) The method includes bonding the reinforcing structure to the cover material; and / or (i) The method includes bonding or welding the reinforcing structure to the cover material by thermal bonding or ultrasonic welding.

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

[0206] In further examples: (a) the cover material comprises a woven material; and / or (b) the method comprises inserting an air-impermeable sealing layer into the interior of a reinforcing structure, wherein the sealing layer comprises an elongated cylindrical shape when inserted into the interior of the reinforcing structure, and adhering the sealing layer to the cover material.

[0207] In the example, the method includes supporting the reinforcing structure on a mandrel and sliding the cover material on the reinforcing structure.

[0208] In the example, the method includes supporting the reinforcing structure on a mandrel and covering the periphery of the reinforcing structure with a covering material.

[0209] In the example, the method includes holding the cover material in an open state and inserting the reinforcing structure into the cover material.

[0210] In the example: The method includes preheating the cover material.

[0211] In the example, the method includes preheating the cover material by blowing hot air, and then inserting the sealing layer.

[0212] In the example, the method includes blowing hot air from a mandrel inserted into the cover material.

[0213] In the example, the method includes supporting the sealing layer on a mandrel and inserting the mandrel and the sealing layer into the interior of a reinforcing structure.

[0214] In the example, the method includes blowing hot air into the interior of the sealing layer to expand it and bond it to the cover material.

[0215] In the example: the mandrel has a low-friction surface.

[0216] In an example, the method includes supporting a sealing layer on a mandrel balloon and expanding the sealing layer by inflating the balloon with hot air to bond the sealing layer to a cover material. Another aspect of the present technology includes a method for manufacturing an air delivery conduit. This air delivery conduit is configured to deliver an airflow under pressure from a respiratory pressure therapy device to a patient interface for the provision of respiratory pressure therapy to a patient. The method includes:

[0217] To support an expandable, air-impermeable cover material for an air delivery conduit, the cover material comprising an elongated cylindrical shape including an external and internal; To extend the cover material; Inserting a slender, flexible reinforcing structure into the cover material; This includes releasing the cover material, allowing it to come into contact with the reinforcing structure.

[0218] In the example: (a) The method includes inserting an elongated flexible reinforcing structure into the cover material while supporting the reinforcing structure on a mandrel, and removing the mandrel from the inside of the cover material, leaving the reinforcing structure inside the cover material; (b) The method includes expanding the cover material by applying an air pressure to the inside of the cover material that is higher than the air pressure to the outside of the cover material; (c) The method includes releasing the cover material by removing the higher air pressure; (d) The method includes expanding the cover material by applying a vacuum to the outside of the cover material; (e) The method includes releasing the cover material by releasing the vacuum; (f) The method includes supporting the cover material at its ends with a vacuum fixture; and / or (g) The method includes generating a vacuum between the outside of the cover material and the vacuum fixture, the vacuum fixture being wider than the cover material, thus enabling the expansion of the cover material.

[0219] In the example: (a) The elongated reinforcing structure includes a plurality of spaced support structures, each support structure being wider than the cover material when in contact with it; (b) After the mandrel is removed from inside the cover material, the air delivery conduit includes grooves in the cover material between adjacent pairs of support structures; (c) The mandrel includes a plurality of teeth, these teeth configured to allow the support structure to slide along the mandrel in a first direction and to prevent the support structure from sliding along the mandrel in a second direction opposite to the first direction; (d) Each tooth includes a first wall and a second wall, the first wall being tapered with respect to the central axis of the mandrel and the second wall being perpendicular to the central axis of the mandrel, the first wall being configured to allow the support structure to slide on each tooth in a first direction and the second wall being configured to prevent the support structure from sliding along the mandrel in a second direction; (e) The mandrel is (f) Each set of teeth comprises multiple sets of teeth spaced apart along the mandrel, each set of teeth configured to prevent each support structure from sliding along the mandrel in a second direction; (g) Each set of teeth comprises multiple teeth arranged concentrically around the central axis of the mandrel at each point along the central axis; (h) The teeth are biased to a position projecting outward relative to the central axis of the mandrel and can be pushed inward relative to the central axis of the mandrel, thereby allowing the support structure to slide on the teeth in a first direction; (i) The method comprises at least partially bonding the cover material to the reinforcing structure before removing the mandrel from inside the cover material; the method comprises bonding the cover material to the reinforcing structure after removing the mandrel from inside the cover material; (j) The method comprises heat bonding, ultrasonic welding, and bonding the cover material to the reinforcing structure; and / or (k) Each support structure takes the form of a ring member.

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

[0221] In further examples: (a) the cover material comprises a first internal layer and a second external layer, the first layer comprising an air-impermeable sealing layer; (b) the second layer comprising a woven material; (c) the method comprising weaving the woven material; (d) the method comprising fabricating the woven material; (e) the woven material comprising a non-woven structure; (f) the method comprising forming the cover material from a sheet into an elongated cylindrical shape by joining opposing edges of the sheet, the sheet being a laminate formed of the first and second layers; and / or (g) the method comprising forming the cover material into an elongated cylindrical shape (by providing 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 polymer material; (b) the first layer is formed from a thermoplastic material; (c) the thermoplastic material includes thermoplastic polyurethane; (d) the first layer includes a thickness of less than 0.5 mm; (e) the first layer includes a thickness of less than 0.2 mm; (f) the first layer includes a thickness of less than 0.15 mm; and / or (g) the first layer includes a thickness of less than 0.1 mm.

[0223] In the example, the method includes expanding the cover material by applying an air pressure to the inside of the cover material that is higher than the air pressure to the outside of the cover material.

[0224] In the example, the method involves releasing the cover material by removing higher air pressure.

[0225] In the example, the method includes expanding the cover material by applying a vacuum to the outside of the cover material.

[0226] In the example, the method includes releasing the cover material by releasing the vacuum.

[0227] In the example, the method includes supporting the cover material at its edges using a vacuum fixture.

[0228] In the example, the method involves generating a vacuum between the outside of the cover material and a vacuum fixture, the vacuum fixture being wider than the cover material, thus allowing the cover material to expand.

[0229] In the example, the method includes inserting an elongated, flexible reinforcing structure into the cover material while supporting the reinforcing structure on a mandrel, and removing the mandrel from inside the cover material, leaving the reinforcing structure inside the cover material.

[0230] In the example, the elongated reinforcing structure includes several spaced ring members, each of which is wider than the cover material when in contact with it.

[0231] In the example: After the mandrel is removed from inside the cover material, the air delivery conduit includes grooves in the cover material between adjacent ring member pairs.

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

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

[0234] In the example, the mandrel includes several sets of teeth spaced apart along the mandrel, the teeth of which are configured to prevent each ring member from sliding along the mandrel in a second direction.

[0235] In the example, each set of teeth includes multiple teeth arranged concentrically around the central axis of the mandrel at each point along the central axis.

[0236] In the example, the teeth are biased to a position projecting outward relative to the central axis of the mandrel and can be pushed inward relative to the central axis of the mandrel, thereby causing the ring member to slide on the teeth in a first direction.

[0237] In the example, the teeth are spring-biased to a position that protrudes outward.

[0238] In the example, the method includes at least partially bonding the cover material to the reinforcing structure before removing the mandrel from inside the cover material.

[0239] In the example, the method includes removing the mandrel from inside the cover material and then bonding the cover material to the reinforcing structure.

[0240] In the example, the method includes one of the following: heat bonding, ultrasonic welding, and bonding the cover material to the reinforcing structure.

[0241] An air delivery conduit included in another aspect of the present technology is configured to deliver an airflow under pressure from a respiratory pressure therapy device to a patient interface for the provision of respiratory pressure therapy to a patient, and the air delivery conduit includes: A flexible reinforcing structure including multiple support structures arranged at intervals along the length of the air delivery conduit; An air-impermeable cover material provided on a support structure along the length of an air delivery conduit, wherein airflow can be transported during use through the sealed air path formed by the cover material; The cover material includes an outer surface formed from a woven fabric.

[0242] In the example: (a) The cover material is in the form of a laminate and includes an outer layer containing 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 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 cover material includes a weight of less than 250 GSM; the weight of the cover material is less than 180 GSM.

[0243] An air delivery conduit included in another aspect of the present technology is configured to deliver an airflow under pressure from a respiratory pressure therapy device to a patient interface for the provision of respiratory pressure therapy to a patient, and the air delivery conduit includes: A woven layer formed from a woven fabric, the woven layer comprising: A first portion formed from a first fiber network of a fabric, wherein the first portion has a first rigidity; A second portion formed from a second fiber network of a fabric, wherein the second portion is treated by a hardening process to have a second rigidity higher than the first rigidity; During use, airflow can be transported through a sealed air path formed by the air delivery conduit.

[0244] In the example: (a) the fabric layer includes an active material provided to the second portion, and the active material causes the second portion to be cured after the 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 heat treatment; (b) the active material includes at least one of a thermosetting material and a thermoplastic material; (c) the second portion of the woven layer includes a cured portion; (d) the second fiber network includes a plurality of cured thermosetting fibers; (e) the second portion of the woven layer includes a molten portion; (f) the second fiber network includes a plurality of fibers that are at least partially molten together; and / or (g) the second fiber network includes a fiber that is at least partially molten together with one or more surrounding fibers.

[0246] In the example: (a) the curing process comprises a photoactivating treatment; (b) the active material comprises a photoactive material that cures a second part of a fabric layer after the addition of visible or invisible light to the second part; (c) the second part of the fabric layer comprises the cured part; (d) the second fiber network comprises a plurality of fibers formed from the photoactive material.

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

[0248] In further examples: (a) the curing process comprises a chemically activated treatment; (b) the active material comprises one or more materials that chemically react after being added to the second site to cure the second site of the fabric layer; (c) the active material comprises a crosslinking agent; (d) the active material comprises the cured material.

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

[0250] In further examples: (a) each of the at least one second part comprises a substantially rigid part; (b) the fabric comprises a plurality of first parts; (c) the fabric comprises a plurality of second parts; (d) the fabric comprises a plurality of first parts and a plurality of second parts arranged alternately along the air delivery conduit; (e) each of the at least one second part comprises a plurality of ring parts arranged at intervals along the air delivery conduit; (f) each of the at least one second part comprises at least one helical part extending helically along the air delivery conduit; and / or (g) each of the at least one second part comprises a plurality of helical parts extending helically along the air delivery conduit.

[0251] In further examples: (a) the fabric layer is air-impermeable and forms a sealed air passage; (b) the air delivery conduit includes a sealing layer within the fabric layer, the sealing layer forming a sealed air passage; (c) the fabric layer is bonded to the sealing layer; (d) the sealing layer comprises a thermoplastic material; (e) the sealing layer comprises 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 further examples: (a) the fabric layer includes a circular cross-section; and / or (b) the fabric layer includes 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 withstand hydrolysis; (d) the inner film layer is antimicrobial; (e) the inner film layer comprises ether-type TPU; and / or (f) the softening temperature of the outer film layer is lower than that of the inner film layer.

[0254] In the example: (a) the air delivery conduit includes a first end configured to connect to a tubular material connected to the outlet of a respiratory pressure therapy device and a second end configured to connect to a patient interface; (b) and / or the air delivery conduit also includes a first end configured to connect to the outlet of a respiratory pressure therapy device and a second end configured to connect to a patient interface.

[0255] In the example, the fabric layer includes an active material provided in the second area, and the active material causes the second area to harden after the hardening process.

[0256] In the example: the first fiber network comprises the first material, and the second fiber network comprises the active material.

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

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

[0259] In the example, the active material includes at least one of a thermosetting material and a thermoplastic material.

[0260] In the example, the second portion of the woven layer includes a hardened portion.

[0261] In the example, the second fiber network includes multiple cured thermosetting fibers.

[0262] In the example, the second fiber network includes a dissolved portion.

[0263] In the example: The second fiber network includes multiple fibers that are at least partially dissolved together.

[0264] In the example: The second fiber network includes fibers that are at least partially dissolved in relation to one or more surrounding fibers.

[0265] In the example: the hardening process includes photoactivation therapy.

[0266] In an example: The active material includes a photoactive material that cures a second site of the fabric layer after addition of visible or non-visible light to the second site.

[0267] In an example: The fabric layer includes a cured portion.

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

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

[0270] In an example: The active material includes a pressure-active material that cures a second site of the fabric layer after addition of pressure to the second site.

[0271] In an example: The active material includes an adhesive that cures the second fiber network after addition of pressure to the second site.

[0272] In an example: The active material includes a microencapsulated adhesive.

[0273] In an example: The second fiber network includes a plurality of adhesive fibers that are each adhered to surrounding fibers by addition of pressure to the second site.

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

[0275] In an example: The active material includes one or more materials that chemically react after addition to the second site to cure the second site of the fabric layer.

[0276] In an example: The active material includes a crosslinking agent.

[0277] In an example: The active material includes a cured material.

[0278] In an example: The fabric layer is formed by knitting or weaving.

[0279] In an example: The fabric layer is formed by circular knitting.

[0280] In an example: The fabric layer is formed by flat knitting.

[0281] In an example: Each at least one second part includes a substantially rigid part.

[0282] In an example: The fabric layer includes a plurality of first parts.

[0283] In an example: The fabric layer includes a plurality of second parts.

[0284] In an example: The fabric layer includes a plurality of first parts and a plurality of second parts that are alternately arranged along the air delivery conduit.

[0285] In an example: At least one second part includes a plurality of ring parts that are spaced apart along the air delivery conduit.

[0286] In an example: At least one second part includes at least one helical part that extends helically along the air delivery conduit.

[0287] In an example: At least one second part includes a plurality of helical parts that each extend helically along the air delivery conduit.

[0288] In an 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 the fabric layer, and the sealing layer forms a sealed air path.

[0290] In an example: The fabric layer includes a circular cross-section.

[0291] In an example: The fabric layer includes a D-shaped cross-section.

[0292] Another aspect of this technology includes a method for manufacturing an air delivery conduit. This air delivery conduit is configured to deliver an airflow under pressure from a respiratory pressure therapy device to a patient interface for the provision of respiratory pressure therapy to a patient. The method includes: The invention involves forming a fabric layer for an air delivery conduit, wherein the fabric layer comprises at least one first portion formed from a first fiber network and at least one second portion formed from a second fiber network. A hardening process is applied to the second part of the woven layer to give it greater rigidity than the first part of the woven layer; During use, airflow can be transported through a sealed air path formed by the air delivery conduit.

[0293] In the example: (a) the method comprises weaving or knitting a fabric; (b) the method comprises weaving or knitting a circular fabric; (c) the method comprises weaving or knitting a fabric; (d) the method comprises weaving or knitting a fabric; (e) the method comprises weaving or knitting a fabric into an elongated cylindrical shape; and / or (f) the method comprises 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) a method comprising providing an activated material to a second portion of a fabric layer, wherein the second portion is cured by a curing process due to the activated material; (b) a method comprising forming a first portion with fibers formed from a first material and forming a second portion with fibers formed from an activated material; (c) a method comprising forming a second portion with both fibers formed from a first material and fibers formed from an activated material; (d) a method comprising providing an activated material to a second portion of a fabric layer after the fabric layer has been formed; and / or (e) a method comprising providing more than one activated material to a second portion of a fabric layer.

[0295] In further examples, (a) the activated material includes a heat-treatable material; (b) the activated material includes a material with a lower melting point than the first material; (c) the activated material is more easily curable than the first material; (d) the activated material includes a thermosetting material; (e) the activated material includes a thermoplastic material; (f) the activated material includes a photoactive material that cures a second part of a fabric layer when exposed to visible or invisible light; (g) the activated material includes a pressure-activated material that cures a second part of a fabric layer when pressure is applied to the second part; (h) the activated material includes a microencapsulated adhesive; (i) the activated material includes one or more chemically activated materials configured to cure a second part of a fabric layer by a chemical reaction; and / or (j) the activated material includes a crosslinking agent.

[0296] In further examples: (a) The hardening process includes heat-treating a second portion of the fabric layer; (b) The step of heat-treating the second portion includes hardening the fabric fibers within the second portion by heating the second portion; (c) The step of heat-treating the second portion includes hardening the fabric fibers within the second portion; (d) The step of heat-treating the second portion includes at least partially dissolving the fabric fibers within the second portion; (e) The step of heat-treating the second portion includes softening the fabric fibers within the second portion by heating the second portion and the softened second portion (f) The step of heat-treating a second area includes melting the fibers of the fabric within the area and melting them into the surrounding fibers; (g) The method includes creating a sealed air passage by sealing the fabric layer; (h) 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; and / or (i) The method includes heat-treating a second area in the step of adhering the sealing layer to the fabric layer.

[0297] In further examples: (a) The curing process includes performing a photoactivation process to cure a second portion of the fabric layer; (b) The method includes activating a photoactive material provided in the second portion of the fabric layer by adding visible or invisible light to the second portion of the fabric layer, thereby curing the second portion with the photoactive material; (c) The method includes curing the second portion of the fabric layer using visible or invisible light.

[0298] In further examples: (a) The curing process includes curing a second portion of a fabric layer by applying pressure to the second portion; (b) The method includes curing a second portion with an adhesive by applying pressure to the second portion; (c) The method includes activating a microencapsulated adhesive by applying pressure to the second portion.

[0299] In further examples: (a) The curing process comprises curing a second portion of the fabric layer by inducing a chemical reaction; (b) The method comprises curing a second portion of the fabric layer by inducing a chemical reaction by providing one or more materials to the second portion of the fabric layer; (c) The method comprises providing a crosslinking agent to the second portion of the fabric layer.

[0300] In further examples: (a) the method comprises forming a plurality of first portions and a plurality of second portions in the formation of a fabric layer; (b) the method comprises forming a plurality of first portions and a plurality of second portions alternately along a fabric layer; (c) the method comprises forming a plurality of second portions as spaced ring portions along a fabric layer; and / or (d) the method comprises forming a single second portion in the form of a helical portion extending spirally along an air delivery conduit.

[0301] In further examples: (a) the method comprises preheating the fabric layer; (b) the method comprises creating a sealed air passage by sealing the fabric layer; (c) the step of sealing the fabric layer comprises inserting the sealing layer into the fabric layer and adhering the sealing layer to the fabric layer; (d) the method comprises preheating the fabric layer by blowing hot air before inserting the sealing layer; (e) the method comprises blowing hot air from a mandrel inserted into the fabric layer; (f) the method comprises supporting the sealing layer on the mandrel. (g) a method comprising: (h) a method comprising: (i

[0302] In the example: The method includes weaving or knitting a fabric.

[0303] In the example: The method involves weaving a circular fabric.

[0304] In the example: The method involves weaving a fabric horizontally.

[0305] In the example, the method includes providing an activated material to a second portion of the fabric layer, and the second portion is cured by a curing process due to the activated material.

[0306] In the example, the method includes forming a first portion with fibers formed from a first material and forming a second portion with fibers formed from an activated material.

[0307] In the example, the method involves forming the second portion with both fibers formed from the first material and fibers formed from the activated material.

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

[0309] In the example, the method involves providing more than one activated material to a second portion of the fabric layer.

[0310] In the example, the activated material includes a heat-treatable material.

[0311] In the example, the activated material has a lower melting point than the first material.

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

[0313] In the example, the method includes forming the second part from a thermosetting material.

[0314] In the example, the method includes forming the second part from a thermoplastic material.

[0315] In an example, the method involves forming a second portion using both a thermosetting material and a thermoplastic material.

[0316] In the example, the activated material includes a photoactive material that hardens a second portion of the fabric layer when exposed to visible or invisible light.

[0317] In the example, the activated material includes a pressure-activated material that hardens a second portion of the fabric layer when pressure is applied to the second portion.

[0318] In the example, the activated material includes a microencapsulated adhesive.

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

[0320] In the example, the activated material contains a crosslinking agent.

[0321] In the example, the hardening process involves heat-treating a second portion of the fabric layer.

[0322] In the example, the step of heat-treating the second part includes hardening the textile fibers within the second part by heating the second part.

[0323] In the example, the step of heat-treating the second part includes hardening the fibers of the fabric within the second part.

[0324] In the example, the step of heat-treating the second part includes at least partially dissolving the textile fibers within the second part.

[0325] In the example, the step of heat-treating the second part includes heating the second part to soften the textile fibers within the second part and cooling the softened textile fibers within the second part to melt them into the surrounding fibers.

[0326] In the example, the step of heat-treating the second part includes melting the fibers of the fabric within the second part and cooling the fibers to melt them into the surrounding fibers.

[0327] In the example, the hardening process includes performing a photoactivation process to harden a second portion of the fabric layer.

[0328] In an example, the method includes activating a photoactive material provided in a second portion of a fabric layer by applying visible or invisible light to the second portion, thereby curing the second portion with the photoactive material.

[0329] In the example, the method includes curing a second portion of the fabric layer using visible or invisible light.

[0330] In the example, the hardening process involves hardening a second portion of the fabric layer by applying pressure to that second portion.

[0331] In the example, the method includes curing the second part with an adhesive by applying pressure to the second part.

[0332] In the example, the method includes activating the microencapsulated adhesive by applying pressure to a second site.

[0333] In the example, the hardening process involves hardening a second portion of the fabric layer by inducing a chemical reaction.

[0334] In the example, the method includes curing the second part of the fabric layer by causing a chemical reaction by providing one or more materials to the second part of the fabric layer.

[0335] In the example, the method includes providing a crosslinking agent to a second portion of the fabric layer.

[0336] In the example, the method includes forming a plurality of first parts and a plurality of second parts when forming a fabric layer.

[0337] In the example, the method involves alternately forming a plurality of first parts and a plurality of second parts along a fabric layer.

[0338] In the example, the method involves forming a plurality of second parts as ring portions arranged at intervals along the fabric layer.

[0339] In an example: The method involves forming a single second portion in the form of a helical portion extending spirally along an air delivery conduit;

[0340] In the example, the method involves creating a sealed air passage by sealing the fabric layer.

[0341] In the example, the step of sealing the fabric layer includes inserting the sealing layer into the fabric layer and adhering the sealing layer to the fabric layer.

[0342] In the example, the method includes heat-treating the fabric layer in the step of bonding the sealing layer to the fabric layer.

[0343] In the example, the method includes supporting the sealing layer on a mandrel and inserting the mandrel and the sealing layer into the interior of the fabric layer.

[0344] In the example, the method includes expanding the sealing layer by blowing hot air into it and bonding it to the fabric layer.

[0345] In the example, the method involves heat-bonding the sealing layer to the fabric layer.

[0346] In the example, the method includes adhering the sealing layer to the fabric layer.

[0347] In the example, the method includes supporting the sealing layer on a mandrel balloon, and expanding the sealing layer by inflating the balloon with hot air, thereby joining the sealing layer to the fabric layer.

[0348] Another aspect of the technology includes a patient interface assembly. This patient interface assembly includes a patient interface configured to engage in a sealed manner with the patient's face when in use, and an air delivery conduit as described in any one of the above aspects or examples. 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 therapy system configured to deliver pressurized respiratory gas to a patient's airway. The system includes a respiratory therapy device configured to pressurize a flow of respiratory gas and an air delivery conduit as described in any one of the above aspects or examples. The air delivery conduit is connectable to the respiratory therapy device to receive a flow of pressurized respiratory gas from the respiratory therapy device.

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

[0351] Another aspect of this technology relates to an air delivery conduit configured to transport 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. This reinforcing structure may be configured to withstand crushing forces applied to the air delivery conduit. The air delivery conduit may also include a sealing strip added to the reinforcing structure along the length of the air delivery conduit. The air delivery conduit may further include an air-impermeable woven fabric cover material surrounding the reinforcing structure and the sealing strip. The woven fabric cover material may form a sealed gas channel 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 woven fabric cover material may meet at an inner seam or overlap at an inner seam. The sealing strip may also be aligned with a seam.

[0352] The longitudinal length of the reinforcing structure may be adjustable. In addition, the woven fabric cover material may be joined to itself at a location near the inner seam. Sealing strips may be joined to the reinforcing structure and / or the woven fabric cover material. In addition, the sealing strips may include a thermoplastic material. The sealing strips may be heat-bonded to the reinforcing structure and / or the woven fabric cover material. The air delivery conduit may further include an outer strip joined to the outside of the woven fabric cover material along the second edge of the woven fabric cover material. The first edge of the woven fabric cover material and / or the second edge of the woven fabric cover material may be serrated. The woven fabric cover material may have a laminated structure and may include an air-impermeable inner layer and an outer fabric layer. The outer fabric layer may include a woven material. The air-impermeable layer may include a thermoplastic material. The inner seam may be aligned along the centerline of the sealing strip. The reinforcing structure may include a plurality of ring members spaced apart along the length of the air delivery conduit.

[0353] Another aspect of this technology relates to an air delivery conduit configured to transport a pressurized respiratory gas flow under pressure from a respiratory pressure therapy device to a patient interface (for the delivery of respiratory pressure therapy to a patient). This air delivery conduit may include an array of support structures. The array of support structures is spaced along the length of the air delivery conduit and is configured to withstand the 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 woven fabric cover material attached to the outer surface of the support structures along the length of the air delivery conduit. The woven fabric cover material may form a sealed gas channel. For each support structure, each intermediate surface may meet the outer surface at its 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 its 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 inner cross-section 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 an adjacent support structure. Furthermore, each support structure may be movable to a position relative to an adjacent support structure where its central longitudinal axis is offset from the central longitudinal axis of the adjacent support structure and parallel to the central longitudinal axis of the adjacent support structure. The spacing between support structures may vary along the length of the air delivery conduit. For example, support structures may be spaced further apart in the middle of the air delivery conduit than at the ends of the air delivery conduit.

[0355] The woven cover material may surround the arrangement of the support structure, and therefore overlaps with itself at the seams. The woven cover material may have a seamless tubular structure. The air delivery conduit may further include a first connector at a first end configured to connect to a tubular material connected to the 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 cover material itself is joined at a location near the seam.

[0357] In the example, the cover material is joined to the reinforcing structure.

[0358] In the example: the cover material is joined to the sealing strip.

[0359] In the example, the cover material includes a woven fabric, and the sealing strip includes a thermoplastic material.

[0360] In the example, the air conduit further includes an outer strip joined to the outside of the cover material along the second edge of the cover material.

[0361] In the example, the first edge and / or second edge of the cover material are serrated.

[0362] In the example, the cover material has a laminate structure.

[0363] In the example, the cover material includes an air-impermeable inner layer and an outer woven fabric layer.

[0364] In the example: the air-impermeable inner layer includes a thermoplastic material.

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

[0366] In the example, the reinforcing structure includes multiple support structures arranged at intervals along the length of the air delivery conduit.

[0367] In the example, the air delivery conduit includes a first end configured to connect to a tubular material connected to the outlet of a respiratory pressure therapy device, and a second end configured to connect to a patient interface.

[0368] The patient interface assembly may include a patient interface configured to engage airtightly with the patient's face during use. The patient interface assembly may also include an air delivery conduit having one of the reinforcing structures, connectors, and cover materials described above. The air delivery conduit may be connectable to the patient interface to deliver pressurized breathing gas to the patient interface.

[0369] A respiratory therapy system may be configured to deliver pressurized respiratory gas to a patient's airway and may include a respiratory therapy device configured to pressurize the flow of respiratory gas. The respiratory therapy system may also include an air delivery conduit having one of the reinforcing structures, connectors, and cover materials described above. The air delivery conduit may be connectable to a respiratory therapy device to receive a flow of pressurized respiratory gas from the respiratory therapy device.

[0370] Another aspect of this technology relates to an air delivery conduit configured to transport a flow of pressurized respiratory gas from a respiratory pressure therapy device to a patient interface for delivery to a patient for respiratory pressure therapy. 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 crushing forces 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 woven fabric cover material may be attached to the outer surface of the support structures along the length of the air delivery conduit. The woven fabric cover material may create a sealed gas flow. At least one of the support structures may include a pair of thickened sections 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 end of the air delivery conduit may differ from the shape of the outer surface of the support structure at the middle of the air delivery conduit. For example, the shape of the outer surface of the support structure at the end of the air delivery conduit may be circular, while the shape of the outer surface of the support structure at the middle of the air delivery conduit may be oval.

[0372] The inner surface shape of each support structure may be non-circular. The inner surface shape of each support structure may be oval. The minor axis of the oval inner surface shape may extend through a pair of thickened sections. The major axis of the oval inner surface shape may extend through a pair of thickened sections. The outer surface shape of each support structure may be circular. The outer surface shape of each support structure may be non-circular. The outer surface shape of each support structure may be oval. The major axis of the oval outer surface shape may extend through a thickened section. Since the woven cover material can surround the arrangement of support structures, the woven cover material overlaps with itself at the seams. The woven cover material may have a seamless tubular structure.

[0373] Another aspect of this 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 the 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 the crushing forces applied to the air delivery conduit. A sealed gas channel is formed by enclosing the support structures with a laminated air-impermeable cover material, and the woven cover material may include an outer layer made of woven material and an air-impermeable inner layer. The surface area of ​​the inner layer may be larger than the surface area of ​​the outer layer, so that the flap portion of the inner layer extends beyond the outer layer. In addition, the air-impermeable cover material may overlap itself at the inner seam. The flap portion of the inner layer may be in sealed contact with another 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 the pressurized breathing gas flowing through the air delivery conduit.

[0374] The air delivery conduit may further include an inner sealing strip added to the support structure along the length of the air delivery conduit in the inner seam. This air delivery conduit may further include an outer sealing strip added to the outer layer in the 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 woven material may have a knitted structure, a woven structure, or a non-woven structure. The weight of the cover 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 in the range of 1 mm to 9 mm, 2 mm to 6 mm, 2 mm to 3 mm, about 6 mm or less, or about 3 mm or less.

[0375] Another aspect of this technology relates to an air delivery conduit configured to transport a flow of pressurized respiratory gas from a respiratory pressure therapy device to a patient interface for delivery to a patient for respiratory pressure therapy. The air delivery conduit may include a flexible reinforcing structure extending along the length of the air delivery conduit. This reinforcing structure may be configured to withstand crushing forces applied to the air delivery conduit. A fabric cover material may be attached to the reinforcing structure along the length of the air delivery conduit. A sealing layer may form a sealed gas channel. The reinforcing structure may be positioned between the fabric cover material and the sealing layer.

[0376] This reinforcing structure may include multiple support structures spaced apart along the length of the air delivery conduit. The sealing layer may be formed from a thermoplastic material. The woven cover may have a knitted structure. The sealing layer may be heat-bonded to the reinforcing structure and / or the woven cover material. 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 withstand hydrolysis and / or be antimicrobial. The inner film layer may include ether-type TPU. The outer film layer may have a lower softening temperature than the inner film layer. The woven cover material may be seamless. The woven cover material may surround the reinforcing structure. The air delivery conduit may be connectable to the patient interface to deliver pressurized breathing gas to the patient interface.

[0377] Another aspect of this technology relates to a method for manufacturing an air delivery conduit configured to transport a flow of pressurized respiratory gas from a respiratory pressure therapy device to a patient interface for delivery to a patient for respiratory pressure therapy. The method may include adding a tubular woven fabric cover material to the outside of an elongated reinforcing structure. This reinforcing structure may be configured to withstand the crushing force applied to the air delivery conduit. A tubular sealing liner may be inserted into the reinforcing structure. When the tubular sealing liner is expanded, the outer surface of the tubular sealing liner comes into contact with the inner surface of the tubular woven fabric cover material. The tubular sealing liner may be attached to the tubular woven fabric cover material. The tubular sealing liner may form a sealed gas flow path within the air delivery conduit.

[0378] A tubular fabric cover material can be slid on the reinforcing structure in the direction of the longitudinal axis of the mandrel. The tubular fabric cover material can surround the reinforcing structure. The reinforcing structure can be slid into the tubular fabric cover material. The tubular fabric cover material can be preheated before insertion of the tubular sealing liner. Preheating of the tubular fabric cover material can be done by blowing hot air onto the tubular fabric cover material. The tubular sealing liner can be supported on the mandrel, and the tubular sealing layer can be inserted into the reinforcing structure by inserting the mandrel into the reinforcing structure. The tubular sealing liner can be expanded by blowing hot air onto its inner surface and joined to the tubular fabric cover material. The mandrel can have a low-friction surface. The tubular sealing layer can be mounted on a balloon supported on the mandrel, and the tubular sealing layer can be inserted into the reinforcing structure by inserting the balloon and mandrel into the reinforcing structure. The balloon can be inflated by hot air, which expands the tubular sealing film, and the tubular sealing film is joined to the tubular woven fabric cover material.

[0379] Another aspect of this technology relates to a method for manufacturing an air delivery conduit configured to transport a flow of pressurized respiratory gas from a respiratory pressure therapy device to a patient interface for delivery to a patient for respiratory pressure therapy. The method may include forming a tubular woven fabric cover. An elongated reinforcing structure may be supported on a mandrel. This reinforcing structure may be configured to withstand the crushing force applied to the air delivery conduit. One end of the tubular woven fabric cover may be rolled up on itself. The rolled end of the tubular woven fabric cover may be attached to the mandrel. As the tubular woven fabric cover can be rolled up along the length of the mandrel and the reinforcing structure, the remaining portion of the tubular woven fabric cover is rolled up on itself and the tubular woven fabric cover is completely inverted. The mandrel can be removed from the tubular woven fabric cover and the reinforcing structure.

[0380] The tubular woven fabric cover material may include a woven layer and an air-impermeable layer. Before the tubular woven fabric cover material is wound onto the mandrel and reinforcing layer, the woven layer may be provided on the inside of the tubular woven fabric cover material, and the air-impermeable layer may be provided on the outside of the tubular woven fabric cover material. The woven layer may be woven or knitted. Support of the reinforcing structure on the mandrel may be achieved by compressing the mandrel, attaching the reinforcing structure to the mandrel, and expanding the mandrel. When the mandrel is compressed, the reinforcing structure is released after the tubular woven fabric cover material has been completely inverted. The reinforcing structure may be joined to the tubular woven fabric cover material. Joining the reinforcing structure to the tubular fabric may be achieved by heat bonding or ultrasonic welding the reinforcing structure to the tubular woven fabric cover material.

[0381] Another aspect of this technology relates to a method for manufacturing an air delivery conduit configured to transport a pressurized respiratory gas flow from a respiratory pressure therapy device to a patient interface under pressure for delivery to a patient undergoing respiratory pressure therapy. The method may include fixing a tubular fabric cover to a support such that a sealed space is maintained around the outside of the tubular fabric cover. Expansion of the tubular fabric cover can be achieved by creating a pressure difference between the inside of the tubular fabric cover and the sealed space around the outside of the tubular fabric cover. An elongated reinforcing structure may be inserted into the tubular fabric cover, and the reinforcing structure is configured to withstand the crushing force applied to the air delivery conduit. By reducing the pressure difference between the inside of the tubular fabric cover and the sealed space around the outside of the tubular fabric cover, the tubular fabric cover can be brought into contact with the reinforcing structure.

[0382] This pressure difference can be generated by increasing the air pressure inside the tubular woven fabric cover. This pressure difference can also be generated by decreasing the air pressure in the sealed space surrounding the outside of the tubular woven fabric cover. The support can be a vacuum fixture. The vacuum fixture can create a vacuum in the sealed space around the tubular woven fabric cover. The diameter of the vacuum fixture can be larger than the diameter of the tubular woven fabric cover, thus allowing the tubular woven fabric cover to expand. The elongated reinforcing structure can be mounted on a mandrel and then inserted into the interior of the tubular woven fabric cover. The mandrel can be removed from inside the tubular woven fabric cover, and the reinforcing structure can remain inside the tubular woven fabric cover. The elongated reinforcing structure may include multiple spaced support structures. The diameter of the support structures can be larger than the diameter of the tubular woven fabric cover when it is in contact with the support structure. After the mandrel is removed from inside the tubular woven fabric cover material, grooves may be provided in the tubular woven fabric cover material between adjacent pairs of support structures.

[0383] A mandrel may contain multiple teeth. These multiple teeth are configured to allow a support structure to slide along the mandrel in a first direction and to prevent the support structure from sliding along the mandrel in a second direction opposite to the first direction. Each tooth may contain a first wall and a second wall, the first wall being tapered with respect to the 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 on each tooth in a first direction, and the second wall may be configured to prevent the support structure from sliding along the mandrel in a second direction. These multiple teeth may be grouped into multiple sets of teeth spaced longitudinally along the tooth mandrel. Each set of teeth may be configured to prevent each support structure from sliding along the mandrel in a second direction. Each set of teeth may contain multiple teeth arranged radially around the central axis of the mandrel. The teeth may be biased to a position projecting outward relative to the central axis of the mandrel and may be able to be pushed inward relative to the central axis of the mandrel, so that the support structure can slide on the teeth in a first direction. The teeth may be spring-biased to a position projecting outward. The tubular woven fabric cover material may be joined at least partially to the reinforcing structure, after which the mandrel is removed from inside the tubular woven fabric cover material. After the mandrel has been removed from inside the tubular woven fabric cover material, the tubular woven fabric cover material may be joined to the reinforcing structure. The tubular woven fabric cover material may be heat-bonded, ultrasonically welded, or bonded to the reinforcing structure.

[0384] Another aspect of the present technology relates to an air delivery conduit. The air delivery conduit includes one of the reinforcing structure, connector and cover material described above, and may further include a first connector at a first end configured to connect to a tubular material connected to the 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 this technology may relate to a patient interface assembly which may include a patient interface configured to engage airtightly with the patient's face during use. The patient interface assembly may also include an air delivery conduit having one of the reinforcing structures, connectors, and cover materials described above. The air delivery conduit may be connectable to the patient interface to deliver pressurized respiratory gas to the patient interface.

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

[0387] A soft and comfortable-to-the-touch air delivery conduit may be desired by the patient. For example, a patient may find that a soft, pleasant-to-the-touch outer material on the air delivery conduit makes for a more comfortable sleeping experience. When a patient finds the treatment device comfortable and desirable, their treatment compliance may improve. When providing a woven surface for a flexible tube that delivers an air passage between the respiratory pressure therapy device and the patient interface, giving the woven surface high air retention properties and a lightweight construction provides the necessary functionality and comfort for treatment, as well as aesthetic appeal and consumer appeal.

[0388] In contrast to some existing plastic tubes, which have a cold, hard feel, air delivery conduits with an outer surface formed from woven material can have a soft, warm feel. If the patient's device is comfortable and desirable, the patient's treatment compliance may also be higher. Woven tubes can have an appearance closer to bedding than a medical device. Woven tubes may be quieter than plastic tubes when their surface is rubbed. Woven tubes may also have lower tube drag because they can weigh less per unit length than plastic tubes. Furthermore, using woven tubes may allow for a wider variety of tube cross-sections (e.g., inconspicuous cross-sections (e.g., elliptical)).

[0389] Another aspect of this technology relates to a patient interface configured to deliver a breathable gas stream from a respiratory pressure therapy device under pressure for the provision of respiratory pressure therapy to a patient. The patient interface includes: Positioning and stabilization structure, seal-forming structure, The positioning and stabilization structure includes at least one headgear tube configured to be positioned against at least one of the patient's head surface or face surface during use; At least one headgear tube includes at least one elastic support element.

[0390] In the example, the positioning and stabilization structure includes a first headgear tube and a second headgear tube.

[0391] In the 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 and to connect to a sealing structure when in use.

[0392] In the example, the joint is positioned above or behind the patient's head.

[0393] In the example, the headgear tube(s)(single or multiple) has a non-circular cross-sectional area in a plane substantially perpendicular to the length of the tube(s)(single or multiple).

[0394] In the example, the headgear tube(s) includes patient contact and non-contact portions. These patient contact and non-contact portions together define a conduit. This conduit provides a pathway for facilitating the delivery of breathable gas to the seal-forming structure during use.

[0395] In the example, the conduit defined by the patient contact portion and the non-contact portion has a substantially semicircular cross-sectional area in a plane oriented substantially perpendicular to the longitudinal axis of the headgear tube.

[0396] In the example, the patient contact area is substantially flat, and the non-contact area is curved, and these flat and curved shapes define a semicircular cross-sectional area.

[0397] In the example, the patient contact area and the non-contact area are separate parts from each other.

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

[0399] In the example: at least one of the patient contact area and the non-contact area includes at least one layer of woven material.

[0400] In the example, the elastic support element is provided in the non-contact area.

[0401] In the example, the headgear tube includes a plurality of elastic support elements arranged at intervals from one another along the length of the headgear tube(s).

[0402] In the example, the headgear tube includes a single elastic support element.

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

[0404] Another aspect of this technology is a headgear tube for a positioning and stabilization structure. This headgear tube is configured to deliver a breathable airflow under pressure from a respiratory pressure therapy device to a seal-forming structure for the provision of respiratory pressure therapy to a patient during use. This headgear tube includes: A patient contact area configured to be positioned on at least one of the surfaces of the patient's head or face during use; At least one headgear tube includes an elastic support member.

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

[0406] In the example, the headgear tube(s) of this 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 substantially linear / straight portions and arcuate portions.

[0407] In the example, the headgear tube(s) include patient contact and non-contact portions. Both the patient contact and non-contact portions define conduits configured to facilitate the delivery of a breathable gas flow to a seal-forming structure during use.

[0408] In this example, the patient contact area and the non-patient contact area are separate parts that are attached to each other. By attaching these separate parts to each other, at least one joint is obtained. These parts can be attached together by RF welding, bonding or other techniques.

[0409] In this example, at least a portion of the patient contact area is constructed from a soft, flexible material.

[0410] In the example, at least one and preferably both of the patient contact portion and the non-contact portion include at least one layer of woven material. From the layer(s) of woven material, the outer layer(s) of the headgear tube(s) can be obtained.

[0411] In the example, the headgear tube according to this technology may be substantially gas-impermeable. For example, the patient contact portion and the non-contact portion may include at least one layer of gas-impermeable material.

[0412] In the example, the patient contact area includes a layer of woven material and at least one layer of cushioning material. This cushioning material layer may be one or more layers of foam or other soft and flexible materials.

[0413] In the example, at least one elastic support member may be provided in a non-contact area, or optionally in a patient contact area.

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

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

[0416] In the example, the conduit defined by the patient contact portion and the non-contact portion has a substantially semicircular cross-sectional area in a plane oriented substantially perpendicular to the longitudinal axis of the headgear tube.

[0417] In the example, the patient contact area is substantially flat, and the non-contact area is curved, and these flat and curved shapes define a semicircular cross-sectional area.

[0418] In the example, the patient contact area and the non-contact area are separate parts from each other.

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

[0420] In the example: at least one of the patient contact area and the non-contact area includes at least one layer of woven material.

[0421] In the example, the elastic support element is provided in the non-contact area.

[0422] In the example, the headgear tube includes a plurality of elastic support elements arranged at intervals from one another along the length of the headgear tube.

[0423] In the example, the headgear tube includes a single elastic support element.

[0424] In the example: Textile material includes knitted material or woven fabric.

[0425] In the example: the textile material includes a layer of coating material to make the textile material substantially gas-impermeable.

[0426] In the example, 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 the example: the patient contact area includes at least one layer of foam.

[0429] In the example, the headgear tube includes a first connector located at a first end of the headgear tube and a second connector located at a second end of the headgear tube.

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

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

[0432] Another aspect of this technology relates to a method for manufacturing components of a respiratory therapy system. This method includes:

[0433] 1. To form at least a portion of the knitted structure using weaving or knitting techniques; 2. Adding elastic material to the braided structure formed in step (1); 3. Using weaving and knitting techniques in succession to form further parts (one or more) of a knitted structure; and 4. Adding elastic material to one or more additional parts of the braid formed in step (3); 5. Repeat steps (3) and (4) until the desired knitted structure is produced. In the example, this weaving technique may include circular weaving, thus forming at least a portion of the tubular structure being woven. However, other weaving techniques are possible for other shapes and structures of components produced according to the method of this technique.

[0434] In the example, the method may include attaching a second material layer to the knitted structure. The attachment of the second layer may be performed after or simultaneously with the addition of the elastic material to the knitted structure.

[0435] In the example, the method may include the step of curing the elastic material after it has been added to the braided structure.

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

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

[0438] In the example: The method further includes attaching a second material layer to the braided structure.

[0439] In the example, the attachment of the second layer is performed after or simultaneously with the addition of the elastic material to the knitted structure.

[0440] In the example, the method includes the step of curing the elastic material after it has been added to the braided structure.

[0441] Another aspect of this technology relates to a system configured to manufacture components for a respiratory therapy system. This system includes: A woven or knitted module configured to form at least a portion of a knitted structure; A distribution module configured to add elastic material to the parts of a knitted structure that are manufactured by a woven module.

[0442] In this example, the system may be configured to continuously manufacture knitted structures and to add elastic material to the knitted structures after their manufacture. For example, the relative arrangement of the weaving modules and the distribution modules may be such that the distribution modules can add elastic material to parts of the knitted structures as the weaving modules continuously manufacture further parts of the knitted structures.

[0443] In the example, the weaving module may include at least one spool of yarn (e.g., two or more spools). These spools may contain identical or different yarns that can be selected to obtain the desired properties in the knitted structure produced by the system.

[0444] In the example, the weaving module may include a drive mechanism configured to move one or more threads relative to the weaving element, thereby manufacturing a portion of the knitted structure.

[0445] In the example, the system may include a curing tool configured to accelerate or otherwise assist the curing of the elastic material after it has been added to a braided structure. This curing tool may be a UV light source, a heat source, or other components.

[0446] In this example, the system is configured to continuously manufacture knitted structures and to add elastic material to the knitted structures after their manufacture.

[0447] In the example, the relative arrangement of the weaving module and the distribution module is such that the weaving module can add elastic material from the distribution module to a part of the knitted structure as it continuously produces further parts of the knitted structure.

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

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

[0450] In the example: the first spool contains the first type of yarn, and the second spool contains the second type of yarn.

[0451] In the example, the weaving module includes a drive mechanism and weaving elements, and in use, the drive mechanism is configured to move one or more threads relative to the weaving elements, thereby producing a part of the knitted structure.

[0452] In the example, the system may further include a curing tool configured to accelerate or otherwise assist the curing of the elastic material after it has been added to a portion of the braided structure.

[0453] In the example, the curing tool is a UV light source or heat source.

[0454] Another aspect of this technology relates to a method for manufacturing components of a respiratory therapy system. This method includes: 1. Selecting, forming, or manufacturing sheets of material; 2. To form at least one elastic support element by adding an elastic material to produce a base sheet; and 3. To obtain a desired shape or structure by manipulating a base sheet, thereby providing at least a part of a component of a respiratory therapy system.

[0455] In the example, the material sheet may be a woven material (e.g., a knitted material, a woven fabric material, or a mesh material). However, the material sheet may be molded or extruded from a plastic material.

[0456] In the example, the material sheet may be a coated material sheet, which is manufactured according to the method described herein.

[0457] In the example, the method includes attaching a base sheet to a second part to form a component. The base sheet and the second part may differ from each other in at least one embodiment (for example, the second part may not include an elastic support member). Alternatively, the second part may be formed from a different material than the material sheet forming the base sheet.

[0458] In the example, by attaching the base sheet to the second part, a structure having a non-circular cross-sectional area can be formed in a plane substantially perpendicular to the length of the component. For example, the component may have a semi-circular cross-sectional area.

[0459] In other examples, components can be formed by attaching a base sheet to itself. For instance, the base sheet may be manipulated to form a cylindrical or tubular shape, creating a joint for attaching the surfaces of the base sheet together.

[0460] In the example, the method may include RF welding to form a joint for attaching parts of a component together.

[0461] In the example, the method may include providing a second material layer on a base sheet. The second material layer may be a gas-impermeable layer. In the embodiment, providing the second material layer includes attaching the material sheet to a base sheet (e.g., a pre-formed thin film material). Alternatively, the step of providing the second material layer may include injecting a liquid onto the base sheet and diffusing the liquid after adding individual droplets of the liquid to create a second layer. This liquid may be cured after being added to the base sheet.

[0462] In the example, during the step of forming one or more elastic support elements, a relatively thin layer of elastic material is also formed on the material sheet.

[0463] In the example, the material sheet is either a woven fabric or a plastic material.

[0464] In the example, the woven material is a knitted material, a woven fabric material, or a mesh material.

[0465] In the example, the method further includes attaching the base sheet to the second part to form a component.

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

[0467] In the example, the method further includes the step of forming a joint for attaching two parts of a component together by RF welding.

[0468] In the example, the method further includes the step of providing a second material layer on a base sheet.

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

[0470] In the example, the step of providing a second material layer includes pouring a liquid onto a base sheet and curing the liquid.

[0471] In the example, during the step of forming one or more elastic support elements, a relatively thin layer of elastic material is also formed on the material sheet.

[0472] Another aspect of this technology relates to components of a respiratory therapy system. These components include: Layers of textile material, A coating material layer bonded to a layer of textile material, wherein the coating material layer provides a substantially gas-impermeable layer for the component, and the coating material is an adhesive, and Elastic support element provided on a coating material.

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

[0474] In the example, the elastic element may be made of an elastic material (e.g., silicone).

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

[0476] In the example, the coating material may be in at least partial contact with the air passage. For example, in these embodiments, the component does not include any further liners or layers of material for making the textile material completely or partially gas-impermeable.

[0477] Another aspect of this technology relates to a method for forming components of a respiratory therapy system. This method includes the following steps: 1) To provide a layer of woven material; 2) To produce a coated textile material by adding a coating material to a textile material, wherein the coating material creates a substantially gas-impermeable layer; 3) To produce a base sheet having at least one elastic support element by adding an elastic material to the coating material; 4) Manipulating the coated fabric material to form a desired shape corresponding to the shape of the component.

[0478] In the example, the step of adding the coating material may include adding individual droplets of the coating material to the fabric material, injecting the liquid onto the fabric material, or other suitable methods.

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

[0480] In this example, the method may include the step of diffusing the coating material over the fabric material. For example, in this method, a knife spreader or drum applicator, as known to those skilled in the art, may be used.

[0481] In the example, the step of adding the elastic material may be performed after the coating material has been substantially or completely cured. However, the addition of the elastic material may also be performed immediately after the coating material has been applied to the fabric material.

[0482] Another aspect of one form of this technology is a patient interface molded or otherwise constructed together with a peripheral shape that is complementary to the shape of the intended wearer.

[0483] One particular aspect of this technology is a medical device that is easy to use for, for example, a person who has not received medical training, a person who is not very dexterous or lacks insight, or a person who has limited experience using this type of medical device.

[0484] One embodiment of this technology is a portable RPT device that can be carried by a person (for example, around their home).

[0485] One embodiment of this technology is a patient interface that can be cleaned at the patient's home, for example, with soapy water, and does not require any special cleaning equipment.

[0486] The methods, systems, devices, and apparatus described may be embodied in a way that enables improvements in the functionality of processors (e.g., processors of computers for specific purposes, respiratory monitors, and / or respiratory therapy devices). Furthermore, the methods, systems, devices, and apparatus described may enable improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions (e.g., sleep-disordered breathing).

[0487] Of course, some of the above embodiments may form sub-embodiments of the present technology. Furthermore, various combinations of sub-embodiments and / or various other embodiments may constitute even further embodiments or sub-embodiments of the present technology.

[0488] Other features of this 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 This technology is illustrated in the attached drawings as a non-limiting embodiment. In the drawings, similar reference numerals include the following similar elements: [Brief explanation of the drawing]

[0490] [Figure 1A] 4.1 Treatment System: The system includes a patient 1000 wearing a patient interface 3000. This system takes the form of a nasal pillow and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. A bedmate 1100 is also illustrated. The patient is sleeping in a supine sleeping position. [Figure 1B] The system includes a patient 1000 wearing a patient interface 3000. This system takes the form of a nasal mask and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 removes a full face mask and receives positive pressure air from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. The patient is sleeping in a lateral sleeping position. 4.2 Respiratory system and facial anatomy [Figure 2A] This diagram outlines the human respiratory system, including the nasal and oral cavities, larynx, vocal cord folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] This is a diagram of the human upper respiratory tract, including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cord folds, esophagus, and trachea. [Figure 2C] This is a frontal view of the face including several features of surface anatomical structures, including the upper lip, upper lip robe, lower lip robe, lower lip, width of the mouth, medial canthus, nasal wings, nasolabial folds, and corners of the mouth. The superior, inferior, radially medial, and radially lateral directions are also indicated. [Figure 2D]This is a lateral view of the head, including several features of surface anatomical structures, such as the glabella, therion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, ala apex, superior and inferior base of the ear. The superior and inferior, and anterior and posterior directions are also indicated. [Figure 2E] This is a further lateral view of the head. The approximate positions of the Frankforth horizontal and nasolabial angles are indicated. The coronal plane is also shown. [Figure 2F] This is a pedicle view of the nose, including several features such as the nasolabial folds, lower lip, upper lip red, nostrils, subnasal point, columella, nasal tip, main axis of the nostrils, and median sagittal plane. [Figure 2G] This is a lateral view of the surface features of the nose. [Figure 2H] This shows the subcutaneous structure of the nose, including the lateral nasal cartilage, nasal septal cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibrous adipose tissue. [Figure 2I] This shows a mid-nasal incision located approximately a few millimeters from the midline sagittal plane, particularly the medial crura of the nasal septum cartilage and the greater alar cartilage. [Figure 2J] This is a frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae are shown together with the maxilla and mandible. [Figure 2K] This is a lateral view of the skull showing the external shape of the head surface and several muscles. The following bones are illustrated: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is illustrated. The following muscles are illustrated: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle. [Figure 2L] This shows the anterolateral aspect of the nose. 4.3 Patient Interface [Figure 3A] This shows a patient interface in the form of a nasal mask, which is one embodiment of this technology. [Figure 3B] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively large compared to the magnitude of curvature shown in 3C. [Figure 3C]This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively small compared to the magnitude of curvature shown in Figure 3B. [Figure 3D] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature value at this point is zero. [Figure 3E] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively small compared to the magnitude of curvature shown in Figure 3F. [Figure 3F] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively large compared to the curvature shown in Figure 3E. [Figure 3G] A mask cushion containing two pillows is shown. The outer surface of the cushion is illustrated. The edges of the surface are illustrated. The dome region and saddle region are illustrated. [Figure 3H] A mask cushion is shown. The outer surface of the cushion is illustrated. The edges of the surface are illustrated. The path on the surface between point A and point B is illustrated. The straight-line distance between A and B is illustrated. Two saddle regions and a dome region are illustrated. [Figure 3I] The surface of the structure is shown, and one-dimensional holes are present within this surface. The planar curves in the illustration form the boundaries of the one-dimensional holes. [Figure 3J] This is a cross-sectional view through the structure in Figure 3I. The illustrated surface defines the two-dimensional hole in the structure in Figure 3I. [Figure 3K] Figure 3I is a perspective view of the structure including two-dimensional and one-dimensional holes. The surfaces that define the two-dimensional holes in the structure of Figure 3I are also shown. [Figure 3L] This shows a mask with an inflatable bladder that acts as a cushion. [Figure 3M] Figure 3L is a cross-sectional view of the mask, showing the inner surface of the bladder. The inner surface defines the two-dimensional holes within the mask. [Figure 3N] Figure 3L shows a further cross-section through the mask. The inner surface is also illustrated. [Figure 3O] This demonstrates the left-hand rule. [Figure 3P] I will demonstrate the right-hand rule. [Figure 3Q] Shows the left ear, including the left ear spiral. [Figure 3R] Shows the right ear, including the right ear spiral. [Figure 3S] The right hand demonstrates a spiral. [Figure 3T] This is a diagram of a mask that includes a sign of the twist of the spatial curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] This is a diagram of the plenum chamber 3200, showing the median sagittal plane and the central contact surface. [Figure 3V] Figure 3U is a rear view of the plenum chamber. The directions in the figure are perpendicular to the central contact surface. In Figure 3V, the plenum chamber is divided into left-hand and right-hand sides by the median sagittal plane. [Figure 3W] Figure 3V is a cross-sectional view through the plenum chamber, taken in the median sagittal plane shown in Figure 3V. The "central contact" surface is illustrated. The central contact surface is perpendicular to the median sagittal plane. The orientation of the central contact surface corresponds to the orientation of tendon 3210. Tendon 3210 rests on the median sagittal plane and contacts the cushion of the plenum chamber only at two points on the median sagittal plane (i.e., upper point 3220 and lower point 3230). Depending on the geometry of the cushion in this region, the central contact surface may contact both the upper and lower points. [Figure 3X] Figure 3U shows the plenum chamber 3200 in the position for use on the face. The median sagittal plane of the plenum chamber 3200 generally coincides with the median sagittal plane of the face when the plenum chamber is in the position for use. The central contact surface generally corresponds to the "face plane" when the plenum chamber is in the position for use. In Figure 3X, the plenum chamber 3200 is part of a nasal mask, with the upper point 3220 resting approximately on the serion and the lower point 3230 resting on the upper lip. 4.4 RPT Device [Figure 4A]This shows an RPT device based on one form of this technology. [Figure 4B] This is a schematic diagram of the pneumatic path of an RPT device according to one embodiment of this technology. The upstream and downstream directions are indicated with respect to the blower and the patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items placed in the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. 4.5 Humidifier [Figure 5A] This shows an isometric view of a humidifier based on one form of this technology. [Figure 5B] This is an isometric view of a humidifier in one form of this technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. 4.6 Respiratory waveform [Figure 6A] This shows a typical respiratory waveform of a human model during sleep. 4.7 Example of a patient interface of this technology [Figure 7A] This is a partial side view of an air delivery conduit 4300, an example of this technology. [Figure 7B] Figure 7A is a cross-sectional view of the air delivery conduit 4300. [Figure 7C] This is a side view of an air delivery conduit 4300, another example of this technology. [Figure 8] An example of this technology, support structure 4310, is shown. [Figure 9] Figure 8 shows the support structure 4310. [Figure 10] A cross-sectional view of a support structure 4310 according to another embodiment of this technology is shown. [Figure 11] A cross-sectional view of a support structure 4310 according to another embodiment of this technology is shown. [Figure 12A] Another embodiment of this technology, a support structure 4310, is shown. [Figure 12B] Another embodiment of this technology, a support structure 4310, is shown. [Figure 12C] Another embodiment of this technology, a support structure 4310, is shown. [Figure 12D] Another embodiment of this technology, a support structure 4310, is shown. [Figure 12E] Another embodiment of this technology, a support structure 4310, is shown. [Figure 12F] Another embodiment of this technology, a support structure 4310, is shown. [Figure 12G] Another embodiment of this technology, a support structure 4310, is shown. [Figure 12H] Another embodiment of this technology, a support structure 4310, is shown. [Figure 12I] Another embodiment of this technology, a support structure 4310, is shown. [Figure 13] This is a cross-sectional view of an air delivery conduit 4300, another example of this technology. [Figure 14] This is a cross-sectional view of an air delivery conduit 4300, another example of this technology. [Figure 15] This is a cross-sectional view of an air delivery conduit 4300, another example of this technology. [Figure 16A] A ring member 4310 according to another embodiment of this technology is shown. [Figure 16B] A ring member 4310 according to another embodiment of this technology is shown. [Figure 17] A ring member 4310 according to another embodiment of this technology is shown. [Figure 18] An array of multiple support structures 4310 according to another embodiment of this technology is shown. [Figure 19] Figure 18 shows a portion of an air delivery conduit 4300 according to another embodiment of the technology, including the support structure 4310. [Figure 20] An array of multiple support structures 4310 according to another embodiment of this technology is shown. [Figure 21] Figure 20 shows a portion of an air delivery conduit 4300 according to another embodiment of the technology, including the support structure 4310. [Figure 22] A reinforcing structure 4305, which is another example of this technology, is shown. The reinforcing structure 4305 includes a support structure 4310. [Figure 23] This is a schematic diagram of the support structure 4310 in Figure 22 surrounding the mandrel 7000. [Figure 24] The reinforcing structure 4305 in Figure 22 is shown together with the sealing layer 4341. [Figure 25] Figure 24 is a schematic diagram of the assembly shown. [Figure 26] Figure 24 shows the reinforcing structure 4305 and sealing layer 4351 together with the outer sheet 4342. [Figure 27] Figure 26 is a schematic diagram of the assembly in which the outer sheet 4342 surrounds the reinforcing structure 4305. [Figure 28] A portion of the air delivery tube 4300, an example of this technology, is shown. [Figure 29] Figure 28 is a schematic diagram of the air delivery tube 4300. [Figure 30] Figure 28 is a schematic cross-sectional view of a portion of the air delivery tube 4300. [Figure 31] A schematic cross-sectional view of a portion of the air delivery tube 4300, representing another example of this technology, is shown. [Figure 32] A schematic cross-sectional view of a portion of the air delivery tube 4300, representing another example of this technology, is shown. [Figure 33] This is a cross-sectional view of a portion of the air delivery conduit 4300 (before the addition of the sealing layer 4341) in another example of this technology. [Figure 34] This is a cross-sectional view of the air delivery conduit 4300 in Figure 33 during the preheating step. [Figure 35] This is a cross-sectional view of the air delivery conduit 4300 in Figure 33 when the sealing layer 4341 is inserted. [Figure 36] This is a cross-sectional view of the air delivery conduit 4300 in Figure 33 during the bonding step. [Figure 37] This is a cross-sectional view of the air delivery conduit 4300 with the sealing layer 4341 inserted according to another example of this technology. [Figure 38] This is a cross-sectional view of the air delivery conduit 4300 in Figure 37 during the bonding step. [Figure 39] This is a cross-sectional view of the air delivery conduit 4300 in Figure 33, with the sealing layer 4341 added. [Figure 40A]This is a cross-sectional view of a portion of an air delivery conduit 4300, another example of this technology. [Figure 40B] This is a perspective view of a portion of the air delivery conduit 4300, another example of this technology. [Figure 40C] This is a cross-sectional view of a portion of an air delivery conduit 4300, another example of this technology. [Figure 41] This is a schematic diagram illustrating how a sealing layer 4341 is inserted into an outer layer 4342 to form a cover material 4340, as an example of this technology. [Figure 42] Figure 41 is a schematic diagram showing how the cover material 4340 is attached to the reinforcing structure 4305. [Figure 43] This is a schematic diagram of the cover material 4340, as another example of this technology. [Figure 44] This is a schematic diagram illustrating the mandrel 7000 in a compressed state, as shown in another example of this technology. [Figure 45] Figure 44 is a schematic diagram showing the mandrel 7000 in a compressed state (while supporting the reinforcing structure 4305). [Figure 46] This is a schematic diagram showing the mandrel 7000 in its expanded state (supporting the reinforcing structure 4305 in Figure 45). [Figure 47] Figure 44 is a schematic diagram showing how a cover material 4340 is added to a reinforcing structure 4305 supported on a mandrel 7000. [Figure 48] Figure 44 is a detailed schematic diagram showing how a cover material 4340 is added to a reinforcing structure 4305 supported on a mandrel 7000. [Figure 49] Figure 44 is a schematic diagram showing how a cover material 4340 is added to a reinforcing structure 4305 supported on a mandrel 7000. [Figure 50] This is a schematic diagram showing the mandrel 7000 in a compressed state when it is removed from the reinforcing structure 4305. [Figure 51] Figure 44 is a schematic diagram showing how the mandrel 7000 is removed from the air delivery conduit 4300. [Figure 52]This is a schematic diagram of a cover material 4340 supported by a vacuum jig 7100, as another example of this technology. [Figure 53] This is a schematic diagram of the cover material 4340 in Figure 52, supported by a vacuum jig 7100 due to the application of vacuum. [Figure 54] This is a schematic diagram of the mandrel 7000 in which the ring member 4310 of the reinforcing structure 4305 is slid on the mandrel 7000, as another example of this technology. [Figure 55] Figure 54 is a detailed schematic diagram of the mandrel 7000 and ring member 4310. [Figure 56] Figure 54 is a schematic diagram of the mandrel 7000 supporting the reinforcing structure 4305. [Figure 57] This is a schematic diagram of the mandrel 7000 and reinforcing structure 4305 inserted into the cover material 4340 in Figure 52 by the vacuum applied from the vacuum jig 7100. [Figure 58] This is a schematic diagram of the mandrel 7000 and reinforcing structure 4305 inserted into the cover material 4340 in Figure 52 after the vacuum has been released. [Figure 59] Figure 52 is a schematic diagram of the mandrel 7000 when it is retracted from the inside of the cover material 4340. [Figure 60] This is a schematic diagram of an air delivery conduit 4300, another example of this technology. [Figure 61] This is a schematic diagram of an air delivery conduit 4300, another example of this technology. [Figure 62] Figure 61 is a schematic diagram of the sealing layer 4341 before insertion into the outer layer 4346 during the manufacturing of the air delivery conduit 4300. [Figure 63] Figure 62 is a schematic diagram showing the sealing layer 4341 and outer layer 4346 inside the mold 7200. [Figure 64] Figure 63 is a schematic diagram of the air delivery conduit 4300 shown in Figure 61, formed within mold 7200. [Figure 65] This is a schematic diagram of an air delivery conduit 4300, another example of this technology. [Figure 66-1]This is a front view of a patient interface 3000 according to another embodiment of this technology. [Figure 66-2] Figure 66-1 is a side view of the patient interface 3000. [Figure 66-3] Figure 66-1 is a perspective view of the patient interface 3000. [Figure 67-1] A first perspective view of a headgear tube according to an embodiment of this technology is shown. [Figure 67-2] Figure 67-1 is a second perspective view of the headgear tube. [Figure 67-3] Figures 67-1 and 67-2 show the end-on view of the headgear tube. [Figure 67-4] This is a cross-sectional view of a headgear tube according to an embodiment of this technology. [Figure 68] This is a schematic diagram of a system configured for use in a method for manufacturing an air delivery conduit according to an aspect of this technology. [Figure 69] The following shows a typical step in a method for generating an elastic support member on a woven fabric material according to an aspect of this technology. [Figure 70] This document shows a typical step in the method according to an embodiment of this technology, and a typical component of a respiratory device manufactured according to this method. [Figure 71-1] Figure 70 shows further embodiments of the method and components manufactured according to this method. [Figure 71-2] Figure 71-1 shows further embodiments of the method and components manufactured according to this method. [Figure 71-3] Figure 71-1 shows further embodiments of the method and components manufactured according to this method. [Figure 72] Figure 70 shows further embodiments of the method and components manufactured according to this method. [Figure 73] This is a cross-sectional view of a multilayer structure manufactured according to the method shown in Figure 72. [Figure 74] Figure 73 shows further embodiments of the method and components manufactured according to this method. [Figure 75]This is a cross-sectional view of a conduit according to one embodiment of this technology. [Figure 76] This is a representative diagram of an elastic support element according to an embodiment of this technology. [Figure 77] A representative step in Method 6600 according to an aspect of this technology and a component generated according to this method are shown. [Figure 78] A representative step in Method 6700 according to an aspect of this technology is shown. [Modes for carrying out the invention]

[0491] 5. Detailed Description of Examples of the Technology Before describing the technology in further detail, it should be understood that the technology is not limited to the specific embodiments which may differ as described herein. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0492] The following description is provided in relation to a variety of embodiments that may share one or more common properties 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 any other embodiment. In addition, any single feature or combination of features in any of these embodiments may constitute a further embodiment.

[0493] 5.1 Treatment In one embodiment, the technology includes a method for treating respiratory diseases. The method includes the step of applying positive pressure to the airway entrance of 1000 patients.

[0494] In certain embodiments of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

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

[0496] 5.2 Treatment System In one embodiment, the technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000.

[0497] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of this technology includes the following functional modes: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 in one form for connection to an air circuit 4170, and a forehead support 3700. In some embodiments, the functional modes may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional modes. When in use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airway to facilitate positive pressure air supply to the airway.

[0498] If a patient interface cannot comfortably deliver the minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0499] A patient interface 3000 in one form of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 6 cmH2O relative to the surroundings.

[0500] A patient interface 3000 in one embodiment of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 10 cmH2O relative to the surroundings.

[0501] A patient interface 3000 in one form of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 20 cmH2O relative to the surroundings.

[0502] 5.3.1 Seal-forming structure In one embodiment of this technology, the seal-forming structure 3100 may provide a target seal-forming region and further provide a cushioning function. The target seal-forming region is the region in the seal-forming structure 3100 where sealing can occur. The region where sealing actually occurs (i.e., the actual sealed surface) may vary from patient to patient in a given treatment session, depending on a range of factors (e.g., the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0503] In one embodiment, the target seal formation region is located on the outer surface of the seal formation structure 3100.

[0504] In a specific embodiment of this technology, the seal-forming structure 3100 is made of a biocompatible material (e.g., silicone rubber).

[0505] The seal-forming structure 3100 according to this technology may be made of a soft, flexible, and elastic material (for example, silicone).

[0506] In certain embodiments of this technology, a system is provided comprising more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate different size and / or shape ranges. For example, the system may include one form of seal-forming structure 3100 suitable for large heads rather than small heads, and another suitable for small heads rather than large heads.

[0507] 5.3.1.1 Sealing mechanism In one embodiment, the seal-forming structure includes a sealing flange using a pressure-assisted sealing mechanism. During use, the sealing flange can readily respond to the positive system pressure within the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism may work in conjunction with elastic tension in the positioning and stabilizing structure.

[0508] In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm). This member extends around the perimeter length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is positioned between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the perimeter length. The support flange is or includes a spring-like element and functions to support the sealing flange so as not to buckle during use.

[0509] In one embodiment, the seal-forming structure may include a compression seal or a gasket seal. During use, the compression seal or gasket seal is constructed and positioned such that it is compressed due, for example, elastic tension in the positioning and stabilizing structure.

[0510] In one embodiment, the seal-forming structure includes a tensioning portion. During use, the tensioning portion is held taut by, for example, an adjacent region of the sealing flange.

[0511] In one embodiment, the seal-forming structure includes a region having an adhesive surface or bonding surface.

[0512] In a particular embodiment of this technology, the seal-forming structure may include one or more of the following: a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or bonding surface.

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

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

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

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

[0517] 5.3.1.4 Jaw region In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the jaw region of the patient's face when in use.

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

[0519] 5.3.1.5 Frontal Area In one embodiment, the seal-forming structure forms a seal on the forehead area of ​​the patient's face when the seal is in use. In this embodiment, the plenum chamber can cover the eye when in use.

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

[0521] A nasal pillow according to one aspect of this technology includes a frustum of a cone. At least a portion of the frustum of the cone forms a seal on the underside of the patient's nose, on the stalk, and on a flexible region on the underside of the frustum of the cone, connecting the frustum of the cone to the stalk. In addition, the structure to which the nasal pillow of this technology is connected includes a flexible region adjacent to the base of the stalk. The flexible region may function to facilitate a flexible connection structure. The flexible connection structure accommodates both the displacement and angle of the frustum of the cone and the mutual movement between the nasal pillow and the structure to which it is connected. For example, the frustum of the cone may be displaced axially toward the structure to which the stalk is connected.

[0522] 5.3.2 Plenum Chamber The plenum chamber 3200 has a perimeter shape that is complementary to the surface contour of an average human face in the area where a seal is formed during use. During use, the peripheral edge of the plenum chamber 3200 is positioned close to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire perimeter of the plenum chamber 3200 during use. In some embodiments, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous material piece.

[0523] In some forms of this technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized space defined by the plenum chamber. In such forms, the pressure is often reduced and / or the wearer's comfort is increased, which can improve treatment compliance.

[0524] In certain forms of this technology, the plenum chamber 3200 is constructed from a transparent material (e.g., transparent polycarbonate). The use of transparent materials can reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of transparent materials may also help clinicians confirm the placement and function of the patient interface.

[0525] In a specific form of this technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the intrusiveness of the patient interface, thereby helping to improve compliance with treatment.

[0526] 5.3.3 Positioning and stabilization structure The seal-forming structure 3100 of the patient interface 3000 of this technology can be held in a sealed position by the positioning and stabilizing structure 3300 during use.

[0527] In one embodiment, the positioning and stabilizing structure 3300 provides at least sufficient holding force to overcome the effect of positive pressure in the plenum chamber 3200 that causes the face to lift away from the face.

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

[0529] In one embodiment, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive effects on the patient interface 3000 (for example, those resulting from tube dragging or accidental interference with the patient interface).

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

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

[0532] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a lateral position with the side of the patient's head resting on a pillow.

[0533] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a release section positioned between the front and rear portions of the positioning and stabilizing structure 3300. This release section is not compressible and may be, for example, a flexible or flimsy strap. The release section is constructed and positioned so as to prevent a situation in which, when a patient lies down with their head on a pillow, the presence of the release section transmits forces along the positioning and stabilizing structure 3300 to the rear, thereby interfering with the seal.

[0534] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam material is porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the fabric outer layer includes a loop material that engages with a hook material portion.

[0535] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., extendable with elasticity) strap. For example, the strap may be configured to be taut when in use, directing the force that brings the seal-forming structure into close contact with a portion of the patient's face. In one embodiment, the strap may be configured as a tie.

[0536] In one embodiment of this technology, the positioning and stabilizing structure includes a first tie, which is constructed and positioned such that, during use, at least a portion of its lower edge passes over the patient's head to the superior base of the ear and covers a portion of the parietal bone without covering the occipital bone.

[0537] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a second tie. The second tie is constructed and positioned such that, when in use, at least a portion of its upper edge passes below the inferior foot of the patient's head and covers or rests on the occipital bone of the patient's head.

[0538] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a third tie constructed and positioned to interconnect the first tie and the second tie to reduce the tendency of the first tie and the second tie to move apart in different directions.

[0539] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. An advantage of this embodiment is that the strap is more comfortable when the patient lies down while sleeping.

[0540] In a particular embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap configured to be breathable, allowing water vapor to pass through its interior.

[0541] In certain embodiments of this technology, a system is provided comprising more than one positioning and stabilizing structure 3300. Each positioning and stabilizing structure 3300 is configured to provide holding force to accommodate different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for a large head rather than a small head, and another form that is suitable for a small head rather than a large head.

[0542] 5.3.3.1 Positioning and stabilization system using conduit headgear Figures 66-1 to 66-3, and more specifically Figure 66-3, show a patient interface 3000 including a plenum chamber 3200. In this example, the patient interface 3000 also includes a positioning and stabilization structure 3300 for holding the plenum chamber 3200 in a sealed position on the patient's face during use. In this example, the positioning and stabilization structure 3300 includes a pair of headgear tubes 3340. These pair of headgear tubes 3340 are interconnected at their upper ends and are configured to be positioned on the upper and lateral surfaces of the patient's head during use. Each headgear tube 3340 is configured to be positioned between the patient's eyes and ears during use. The lower end of each headgear tube 3340 is configured to be fluidly connected to the plenum chamber 3200. In this example, the lower end of each headgear tube 3340 is connected to a headgear tube connector 3344. The headgear tube connector 3344 can be permanently or removably connected to a headgear connector 3246 configured to connect to an inlet port 3240 of the plenum chamber 3200. The positioning and stabilization structure 3300 includes a conduit headgear inlet 3390 at the junction of two headgear tubes 3340. The conduit headgear inlet 3390 is configured to receive a pressurized gas flow through an elbow, for example, including a connection port 3600, and to allow this gas flow to flow into the hollow interior of the headgear tube 3340. These headgear tubes 3340 supply the pressurized gas flow to the plenum chamber 3200.

[0543] The positioning and stabilization structure 3300 may include one or more straps in addition to these headgear tubes 3340. In this example, the positioning and stabilization 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 each other. The joint between the upper straps 3310 and lower straps 3320 is configured to be positioned on the posterior surface of the patient's head, thereby enabling anchoring of the upper straps 3310 and lower straps 3320. The front end of the upper strap 3310 connects to the headgear tube 3340. In this example, each headgear tube 3340 includes a tab 3342 having an opening. Through this opening, each upper strap 3310 can be fed and then looped back and secured to itself, thereby securing the upper headgear strap 3310 to the headgear tube 3340. The positioning and stabilization structure 3300 also includes lower strap clips 3326 provided at the front end of each lower strap 3320. Each lower strap clip 3326 is configured to connect to a lower connection point 3325 on the plenum chamber 3200 in the examples shown in Figures 61-1 to 61-3, where the lower connection points 3325 are located on the headgear connector 3246. In this example, the lower strap clips 3326 are magnetically fixed 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 asphyxiation prevention 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 airflow between the inside of the plenum chamber 3200 and the surroundings. Each AAV may be biased to a configuration that blocks airflow from the inside of the plenum chamber 3200 into each headgear tube 3340 and allows air exchange between the plenum chamber 3200 and the surroundings. When the headgear tube 3340 is pressurized, the AAV in each headgear tube connector 3344 may prevent air exchange between the inside of the plenum chamber 3200 and the surroundings, and allow airflow from each headgear tube 3340 into the plenum chamber 3204 for the patient to breathe.

[0545] In the examples shown in Figures 66-1 to 66-3, a common support base is provided for the upper and lower headgear connectors. That is, at 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. It is conceivable that the formation of the plenum chamber 3200 and the behavior of the seal-forming structure 3100 may be affected due to the tension difference between the upper and lower headgear straps. Separate upper and lower headgear connections (i.e., upper and lower headgear connections that can move relative to each other when the cushion flexes) allow for a certain degree of flexion around the horizontal axis, thereby achieving a better fit for a wider range of patients. By making this flexion adjustable, the fit range and the adjustable range of the patient interface 3000 are further improved, resulting in a more comfortable and effective fit. As described in relation to the headgear support 3302, the use of separate headgear connectors can help provide at least some of the necessary rigidity to the fascia 3210.

[0546] Referring here to Figures 67-1 to 67-3, preferred examples of headgear tubes 3500 according to embodiments of the present art are illustrated. The headgear tube 3500 may be manufactured by the methods described herein or by 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 be sold as a separate component, either as an alternative or as an addition.

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

[0548] The patient contact portion 3502 is formed from at least one layer of material that comes into contact with the patient's skin surface during use. Therefore, these at least one material layer preferably has at least one of biocompatibility, flexibility, and pliability.

[0549] The patient contact area 3502 may have a multilayer structure (for example, having at least two layers). These additional layers (one or more) may be one or more of a gas-impermeable layer, a foam layer, and a second fabric layer. For example, Figure 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 contact area 3502 may be formed of a foam laminate with an outer layer of fabric material 3514 that comes into contact with the patient's skin during use, a distal layer 3516 (for example, 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 area 3502 may be a coated woven material manufactured according to the methods described herein, and therefore may consist only of 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 the 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] The formation of these elastic support elements 3506 is carried out from an elastic material (preferably using the method described herein).

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

[0553] Providing the elastic support element 3506 can offer benefits in delivering respiratory therapy to patients. For example, the elastic support element 3506 can bend and flex in response to force applied to the headgear tube 3500. As a result, pressure on the patient's surface in contact with the headgear tube 3500 can be reduced or eliminated, whereas using a rigid support element or ring within the headgear tube 3500 may increase discomfort for the patient.

[0554] Furthermore, the elastic support element 3506 may be more cost-effective and easier to manufacture than conventionally available structures for headgear tubes used in conduit headgears.

[0555] As shown in Figure 67-4, the non-contact portion may have a multilayer structure and comprises 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 embodiments, 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). The elastic support element 3506 is provided on the non-contact portion 3504 (e.g., on the inner surface of the headgear tube 3500).

[0556] The headgear tube 3500 may be provided in conjunction with other components (for example, a headgear connector 3246, a conduit inlet 3390, or a tab 3342 as was done for the headgear tube 3450).

[0557] Further embodiments of the headgear tube 3506 according to this technology should become clearer from the discussion of the manufacturing method described herein.

[0558] 5.3.4 Ventilation In one embodiment, the patient interface 3000 includes a vent 3400 configured and positioned to allow the expulsion of exhaled gases (e.g., carbon dioxide).

[0559] In a particular configuration, the vent 3400 is configured to allow a continuous airflow from the inside of the plenum chamber 3200 to the atmosphere when the pressure inside the plenum chamber is positive relative to the atmosphere. The vent 3400 is configured to maintain the therapeutic pressure inside the plenum chamber during use, while ensuring that the airflow is large enough to reduce patient rebreathing of exhaled CO2.

[0560] One form of the ventilation section 3400 according to this technology includes a plurality of holes (for example, about 20 to 80 holes, or about 40 to 60 holes, or about 45 to 55 holes).

[0561] The ventilation section 3400 may be located within the plenum chamber 3200. Alternatively, the ventilation section 3400 may be located within a release structure (e.g., a swivel).

[0562] 5.3.5 Decoupled Structures (Multiple or Single) In one embodiment, the patient interface 3000 includes at least one decoupling structure (e.g., a swivel or bulbolar fovea).

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

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

[0565] 5.3.8 Suffocation prevention valve In one embodiment, the patient interface 3000 includes an asphyxiation prevention valve.

[0566] 5.3.9 Ports In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the properties of the gas (e.g., pressure) within the plenum chamber 3200.

[0567] 5.4 RPT Devices An RPT device 4000 according to one aspect of this technology includes mechanical, pneumatic, and / or electrical components and is configured to perform one or more algorithms 4300 (e.g., any of the methods described herein, either entirely or in part). The RPT device 4000 may be configured to generate an airflow delivered to a patient's airway for the treatment of one or more respiratory conditions described in any of the sections herein.

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

[0569] The RPT device may have an external housing 4010. The external housing 4010 is formed by two parts: an upper part 4012 and a lower part 4014. Furthermore, the external housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0570] The pneumatic 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 passage items may be housed within a removable, integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be housed within an external housing 4010. In one embodiment, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

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

[0573] 5.4.1 RPT Devices: Mechanical and Pneumatic Components An RPT device may include one or more of the following components in a single unit. In one alternative configuration, one or more of the following components may be arranged as separate units.

[0574] 5.4.1.1 Air filter (single or multiple) An RPT device according to one embodiment of this technology may include an air filter 4110 or a plurality of air filters 4110.

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

[0576] In one embodiment, the outlet air filter 4114 (e.g., antimicrobial factor) is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0577] 5.4.1.2 Muffler (singular or plural) An RPT device according to one embodiment of this technology may include a muffler 4120 or a plurality of mufflers 4120.

[0578] In one embodiment of this technology, the inlet muffler 4122 is positioned above the pressure generator 4140 within the pneumatic path.

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

[0580] 5.4.1.3 Pressure Generator In one embodiment of this technology, a pressure generator 4140 that generates an airflow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be positioned within a volute. The blower can deliver the air supply at a speed of, for example, up to about 120 liters / minute at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other embodiments 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: 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 WO2013 / 020167.

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

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

[0583] 5.4.1.4 Converters (single or multiple) The converter may be located inside the RPT device or outside the RPT device. The external converter may be located on an air circuit, for example, or may form part of an air circuit (e.g., a patient interface). The external converter may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that transmits or moves the data RPT device).

[0584] In one embodiment of this 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 positioned to generate signals that describe the characteristics of the airflow (e.g., flow rate, pressure, or temperature at that point in the pneumatic path).

[0585] In one embodiment of this technology, one or more transducers 4270 may be located near the patient interface 3000.

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

[0587] 5.4.1.5 Anti-spillback valve In one embodiment of this technology, an anti-spillback valve 4160 may be positioned 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 (for example, 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 embodiment of this technology, the power supply 4210 supplies power only to the RPT device 4000. In another embodiment of this technology, power is supplied from the power supply 4210 to both the RPT device 4000 and the humidifier 5000.

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

[0591] In one embodiment, the input device 4220 may be constructed and configured to allow a human to select a value and / or a menu option.

[0592] 5.4.2.3 Central Controller In one embodiment of this 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 based on ARM® Cortex®-M processors from ARM Holdings (e.g., S®32 series microcontrollers from ST Microelectronics). In certain alternative forms of this technology, 32-bit RISC CPUs (e.g., STR9 series macrocontrollers from ST Microelectronics) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of macrocontrollers manufactured by Texas Instruments) may also be suitable.

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

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

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

[0597] 5.5 Air Circuit An air circuit 4170 according to one aspect of this technology is a conduit or tube constructed and positioned so that airflow moves between two components (e.g., an RPT device 4000 and a patient interface 3000) during use.

[0598] In detail, the air circuit 4170 may be fluidly connected to the outlet and patient interface of the pneumatic block 4020. The air circuit may be called 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 embodiments, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (for example, to maintain or raise the air temperature). The heating elements may take the form of a heating wire circuit and may include one or more transducers (e.g., temperature sensors). In one embodiment, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating elements may communicate with a controller (e.g., a central controller 4230). One embodiment of the air circuit 4170 including a heating 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 tubes, which may feel rigid to the skin. Some existing conduits include corrugated plastic tube materials formed by a helical plastic support structure and plastic tape. In the case of some tubes that include a woven fabric cover material, the corrugated plastic tube may not be able to provide a certain level of flexibility, or it may not be able to provide sufficient flexibility while being crush-resistant.

[0601] A soft and comfortable-to-the-touch air delivery conduit may be desired by the patient. For example, a patient may find that a soft, pleasant-to-the-touch outer material on the air delivery conduit makes for a more comfortable sleeping experience. When a patient finds the treatment device comfortable and desirable, their treatment compliance may improve. When providing a woven surface for a flexible tube that delivers an air passage between the respiratory pressure therapy device and the patient interface, giving the woven surface high air retention properties and a lightweight construction provides the necessary functionality and comfort for treatment, as well as aesthetic appeal and consumer appeal.

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

[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 this example of the art, the air delivery conduit 4300 is part of or forms part of the air circuit 4170. The air delivery conduit 4300 is configured to deliver / transport airflow under pressure from the RPT device 4000 to the patient interface 3000 for the provision 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 withstands occlusion and / or crushing of the air delivery conduit 4300 under forces that would lead to crushing of the air delivery conduit 4300, for example. The air delivery conduit 4300 can be both crush-resistant and flexible. The reinforcing structure 4305 may consist of a single continuous structure or of multiple distinct 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 withstand crushing forces 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] As shown in Figure 7B, the reinforcing 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-sealed members, or any other type of structure, and may provide structural support while also forming the boundary of 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. In addition, each support structure 4310 may be a fully sealed ring, a C-shape (or semi-sealed member), a rectangle, or any other shape that can maintain an unblocked flow path through the air delivery conduit 4300.

[0606] In the example shown in Figure 7B, the reinforcing structure 4305 includes a plurality of separate / individual support structures 4310. These support structures 4310 can be separated from each other rather than being connected to each other. Each support structure 4310 is a separate integral structure, not part of a larger integral structure. In this example, the support structures 4310 are not connected to each other by a cover material 4340. However, these support structures 4310 form the reinforcing structure 4305 of the air delivery conduit 4300. Each support structure 4310 is not joined to an adjacent support structure 4310 within the reinforcing structure 4305, but it may be joined to an adjacent support structure 4310 by a cover material 4340.

[0607] In other examples, the reinforcing structure 4305 includes one or more helical rib members or another skeletal structure. In one example, the helical rib may be a heating element (or wire) 4307 that helically surrounds the air delivery conduit 4300 (see Figure 7C). Alternatively, the helical rib may be a component separate from the heating element 4307. If not in a helical form, the heating element 4307 may extend longitudinally 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 cover material 4340. The cover material 4340 is provided on the reinforcing structure 4305 along the length of the air delivery conduit 4300. Airflow can be delivered from the air delivery conduit 4300 to the patient interface 3000 through the sealed air path (or lumen) formed by the cover material 4340. In some examples, the cover material 4340 includes an outer surface material formed of a woven material. In other examples, the cover material 4340 includes a plastic material (e.g., a thermoplastic material) (e.g., a plastic tape surrounding or wrapped around the reinforcing structure 4305). In some examples, the cover material 4340 includes a sealing layer laminated to or otherwise bonded to the outer woven layer. The cover material 4340 may include a woven sheet. This woven sheet is a sheet comprising a woven material and, optionally, further materials to make the woven sheet air-impermeable. In some examples, the cover material 4340 may include a woven layer containing a woven material and a sealing layer. Thus, the woven sheet may include a laminated structure. In some examples, one or more layers of the woven sheet may include a laminated structure. For example, the woven sheet may include a woven layer and a sealing layer, the sealing layer of which includes a laminate formed from multiple layers (e.g., two material layers).

[0609] In some examples, the cover material 4340 includes nylon, polyester, spandex, or a combination thereof. In some examples, a portion of the air delivery conduit 4300 includes the cover material 4340 formed from a polymer or elastomer film, while in other portions of the air delivery conduit 4300, the cover material 4340 is formed from a woven material. In some examples, the cover material 4340 may include more than one fabric material to provide local features or functions (including, for example, those for visual appeal). In some examples, the cover material 4340 includes areas that are softer than adjacent areas. In some examples, the cover material 4340 includes transparent areas. The transparent areas may allow a user to inspect the inside of the conduit 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., a TPU film). The air-impermeable film may interface with the woven material layer 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 when the outer woven layer encloses the reinforcing structure. In some examples, the sealing layer includes a sealing strip, and in other examples, it is a sheet laminated to the outer sheet of the cover material. In some examples, the cover 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 with the woven material layer and the support structure 4310 (or other reinforcing structure 4305), thereby creating a barrier to air movement between the woven material and the sealed air path within the conduit. In some examples of this technology, the air delivery conduit 4300 having a woven fabric cover material 4340 may be coated with silicone or a similar material (e.g., TPE) to achieve air impermeability.

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

[0612] In contrast to some existing plastic tubes, which have a cold, hard feel, the air delivery conduit 4300, which includes an outer surface formed from a woven material, may have a soft, warm feel. If the patient's device is comfortable and desirable, the possibility of improving the patient's treatment compliance may increase. Woven tubes may have an appearance closer to bedding than a medical device. Woven tubes may be quieter than plastic tubes when their surface is rubbed. Woven tubes may also have lower tube drag because they may weigh less per unit length than plastic tubes. Furthermore, using woven tubes may enable a wider range of diverse tube cross-sections (e.g., inconspicuous cross-sections (e.g., elliptical)).

[0613] 5.5.1 Support structure As shown in Figure 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 an air delivery conduit 4300 that is lightweight, has high flow characteristics and structural strength. The geometry of the support structures 4310 can also enable low noise levels during use. The geometry of the ring members can be selected to obtain a certain range of pipe cross-sections with equivalent airflow and impedance.

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

[0615] The support structure 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 with an outer shape that ensures good adhesion to the cover material 4340 and reduces the risk of rupture of the cover material 4340 during use or manufacture. The inner surface of each support structure 4310 may have an outer shape that avoids turbulence, impedance reduction, and / or unwanted noise. The inner and / or outer shapes of the support structure 4310 may include curved portions. The support structure 4310 may include different shapes (e.g., circular, oval) to obtain different overall pipe cross-sections.

[0616] As will be described in more detail below, with reference to Figure 8, for example, the support structure 4310 may include an outer surface 4312a. The outer surface 4312a is configured to be attached to the cover material 4340 by, for example, joining, bonding, sewing, weaving, or any other attachment method. The shape (e.g., form) of the outer surface 4312a of each support structure 4310 may be such that it ensures sufficient adhesion to the cover material 4340 (e.g., minimizing or eliminating delamination) and reduces the risk of the cover material 4340 bursting during use or manufacture. The shape or form of the outer surface may be the outer shape or outer form 4312 of the support structure 4310.

[0617] The support structure 4310 may also include an inner surface 4313a facing the outer surface 4312a. The inner surface 4313a may be directly exposed to the flow of pressurized gas flowing through the air delivery conduit 4300. Alternatively, the attachment of an air-impermeable film or layer to the inner surface 4313a may be done, for example, by joining, bonding, sewing, weaving, or any other attachment method. The inner surface 4313a of each support structure 4310 may be shaped (e.g., form) in such a way as to avoid turbulence, impedance reduction, and noise motion generation reduction. The shape or form of the inner surface 4313a may be the inner shape or inner outer shape 4313 of the support structure 4310.

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

[0619] The support structure 4310 (e.g., a ring member) may include a pair of intermediate surfaces 4314 that connect 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. In addition, the edges connecting the intermediate surfaces 4314 to the outer surface 4312a may be fillet-shaped (e.g., curved, circular, etc.). Similarly, the edges connecting the intermediate surfaces 4314 to the inner surface 4313a may also be fillet-shaped (e.g., curved, circular, etc.). The support structure 4310 may include a cross section having a circular corner (e.g., an outer circular corner connecting the outer surface 4312a and the intermediate surfaces 4314).

[0620] The support structure 4310 may be substantially rigid or semi-rigid. In some examples, the support structure 4310 may be formed from polycarbonate, nylon, PEEK, polyester, NORYL, etc., or copolymers or mixtures (e.g., PETG, polycarbonate ABS, nylon-polyurethane). The support structure 4310 may be formed from a material having rigidity, toughness, and / or elasticity. In some examples, the support structure 4310 may be formed from a plastic material or an elastomer material. The support structure 4310 may be formed from a material with a softening temperature above 80°C. The support structure 4310 may be formed from a material that bonds well to air-impermeable materials (e.g., plastic film (e.g., thermoplastic polyurethane (TPU) film)). In some examples, the surface of the support structure 4310 may have finish, molding pattern, structure, and / or other treatment aids to improve adhesion between the support structure 4310 and the air-impermeable material. Such treatments can be mechanical (e.g., roughening / polishing), surface energy modification (e.g., plasma / corona / flame), or chemical (e.g., bonding / priming).

[0621] In some examples of this technology, the support structure 4310 is formed from an elastomer (e.g., an elastomer material). In the examples, the support structure 4310 may be formed from silicone or TPE. A support structure 4310 formed from an elastomer material may have sufficient rigidity to withstand the crushing force applied to the air delivery conduit 4300. Furthermore, making the support structure 4310 flexible and elastic may result in a more comfortable feel for the air delivery conduit 4300. By making the jurometer hardness of a support structure 4310 formed from silicone sufficiently high, the support structure 4310 has sufficient rigidity to withstand blockage of the air delivery conduit 4300 during use. Correspondingly, a support structure 4310 formed from TPE may be cured so that the rigidity of the support structure 4310 is sufficient to maintain the open air path within the air delivery conduit 4300 against blockage forces.

[0622] Figure 8 shows the shape of a support structure 4310 for an air delivery conduit 4300 according to an example of the present technology. In this example, the support structure 4310 is formed in a ring shape and can be considered as a ring member. The support structure 4310 includes a circular outer shape 4312. By making the support structure 4310 a circular outer shape 4312, it is facilitated that the air delivery conduit 4300 itself includes a circular outer shape or an overall circular cross-section. In this example, the support structure 4310 includes a non-circular inner shape 4313. In detail, the inner shape 4313 is oval.

[0623] The support structure 4310 shown in Figure 8 includes a pair of thickened sections 4315. The thickened sections 4315 are provided on opposing sides of the support structure 4310. These thickened sections 4315 are advantageous because they increase the strength of the support structure 4310 (compared to the strength it would have if it had a uniform thickness).

[0624] The support structure 4310 can be injection molded. The support structure 4310 includes a gate position 4316 and an overflow position 4317 for molding the support structure 4310. Advantageously, the gate position 4316 and the overflow position 4317 are located in the thickened portion 4315. By locating the gate position and the overflow position in the thickened portion 4315, the formation of weld lines during molding is always located in the thickened portion 4315, which is advantageous. Since weld lines can be weak points in the support structure 4310, providing extra thickness to the thickened portion 4315 provides additional strength to the support structure 4310 at any location of the weld lines.

[0625] In this example, the gate position 4316 is assigned to the surface 4314 of the support structure 4310. Similarly, the overflow position 4317 is assigned to the surface 4314. In some examples, the overflow position 4317 and the gate position 4316 may be located on opposing surfaces of the support structure 4310. One advantage of assigning the overflow position and the gate position to the surface or inner surface of the support structure 4310 is that there are no traces on the outer surface joined to the cover material 4340. If there are defects on the outer surface of the support structure 4310, it may cause the cover material 4340 or its layers to break.

[0626] Figures 16A, 16B, and 17 show 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 in Figure 16A, the gate location 4316 is located on the outer circumferential surface (e.g., outer surface 4312a) of the support structure 4310. In the example in Figure 16B, the gate location 4316 is located on the inner circumferential surface (e.g., inner surface 4313a) of the support structure 4310. In both of these examples, the material can be used efficiently. In the example in Figure 16B, all traces or defects remaining at the gate location are not on the adhesive surface of the support structure 4310, which is advantageous because the risk of breakage of the film or cover material attached to the support structure 4310 is minimal or zero. In the example in Figure 17, the gate location 4316 is located on the inner circumferential surface of the support structure 4310, in a continuous arc around the entire periphery of the support structure 4310. In this example, in the case of support structure 4310, there is no possibility of problems caused by the welding line, and the concentricity may be good, but the amount of material used may be greater in resistivity than in the examples shown in Figures 16A and 16B.

[0627] In some examples, the support structure 4310 includes an opening. For example, in some examples, the support structure 4310 is a circular ring member, but does not form a full circle. Such a support structure 4310 may include an opening, which may be similar to a circlip as shown in Figure 12G. The open support structure 4310 may be advantageous in terms of improved flexibility, which may facilitate assembly with the cover material 4340.

[0628] In some examples, the support structure 4310 includes a flat and thin cross-section, which allows for weight reduction of the pipe. In some examples, the support structure 4310 has features or patterns for improved strength and improved adhesion to the cover material 4340.

[0629] Figure 9 is a cross-sectional view of the support structure 4310 shown in Figure 8. As shown, the support structure 4310 includes a cross section on its outer surface 4312a that includes an outer circular corner portion 4318. In this example, the support structure 4310 includes a circular outer edge because its cross-sectional shape is the outer circular corner portion 4318. In the case of the outer circular corner portion 4318 of the support structure 4310, the risk of the cover material 4340 or its film rupturing when attached to the support structure 4310 during use may be reduced. If the outer periphery of the support structure 4310 includes an acute corner portion, there may be a certain risk of the film or cover material attached to the support structure 4310 rupturing. 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. In the cross-section of the support structure 4310, the inner circular corner portion 4319 may also be included in the inner surface 4313a of the support structure 4310. In this example, the support structure 4310 includes a circular inner edge portion obtained by the inner circular corner portion 4319 of its own cross-sectional shape.

[0630] The radius of curvature of the outer circular corner 4318 may be larger than that 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 larger than that of the outer circular corner 4318. The outer circular corner 4318 and the inner circular corner 4319 are intended to be chamfered or beveled instead of being curved or filleted. Of course, if desired, it is not necessary to provide a rounded, filleted, chamfered, or beveled edge on either the outer circular corner 4318 or the inner circular corner 4319. Also, the outer circular corner 4318 may each have different treatments (i.e., filleted, chamfered, beveled, or untreated). Correspondingly, each of the inner circular corners 4319 may have a different treatment (i.e., filleted, chamfered, beveled, or untreated).

[0631] The outer circular corners 4318 and inner circular corners 4319 of the support structure 4310 may be areas where defects in the air delivery conduit 4300 are likely to occur. In particular, if the outer circular corners 4318 and inner circular corners 4319 are left untreated, fracture or other forms of damage to the cover material 4340 may occur. Treatment of the outer circular corners 4318 and inner circular corners 4319 (e.g., filleting, chamfering, or beveling) may reduce the likelihood of fracture of the cover material 4340.

[0632] In the example shown in Figure 9, the cross-section of the support structure 4310 is substantially rectangular (for example, having 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, quadrangular, trapezoidal, circular, triangular, polygonal, arched, semicircular, or any other suitable shape.

[0633] Figures 10 and 11 are cross-sectional views of the support structure 4310 according to other examples of the present technology. In these examples, the support structure 4310 may also be called a ring member. The support structure 4310 shown in Figure 10 includes an acute corner. An advantage of this support structure 4310 is that the dividing line of the mold tooling device configuration in which the support structure 4310 is injection molded can be aligned with one of the sides of the support structure 4310. This can simplify the tooling device and reduce the likelihood of traces of the dividing line on the outer surface 4312a of the support structure 4310. The support structure 4310 shown in Figure 10 includes an acute corner on one side, allowing the dividing line to be located on that side, while including an outer rounded corner 4318 and an inner rounded corner 4319 on the other side, thus reducing the risk of the cover material 4340 or sealing layer 4341 rupturing due to these corners.

[0634] Figures 12A to 12I show several different support structures 4310 as an example of this technology. It should be understood that the support structures 4310 are not limited to the shapes shown in Figures 12A to 12I.

[0635] The support structure 4310 in Figure 12A includes a circular outer shape 4312 and a circular inner shape 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 its periphery.

[0636] The support structure 4310 in Figure 12B includes a circular outer shape 4312 and a circular inner shape 4313, and the thickness and cross-sectional shape are uniform around the support structure 4310. In this example, the cross-sectional shape of the support structure 4310 includes circular corners and convex inner surfaces similar to the support structure 4310 shown in Figure 8.

[0637] The width of the intermediate surface of the support structure 4310 shown in Figures 12A and 12B may be uniform and constant. Each of these support structures 4310 may have a uniform thickness and cross-sectional shape. Since the outer shape 4312 and the inner shape 4313 may have the same shape (e.g., circular), the outer and inner surfaces may also have the same shape.

[0638] As shown in the figure, the support structure 4310 in Figure 12B may be thicker than the support structure 4310 in Figure 12A. That is, the intermediate surface 4314 of the support structure 4310 in Figure 12B may be wider than the intermediate surface 4314 in Figure 12A, by joining the outer and inner surfaces. In addition, the edge of the outer surface 4312 of the support structure 4310 in Figure 12B may be rounded or filleted.

[0639] The support structure 4310 in Figures 12C to 12F may have thickened sections 4315 on opposing sides, which can be achieved by changing the width of the intermediate surface 4314. As a result, the outer surface 4312 and inner surface 4313 may have different shapes. The configuration using thickened sections may increase the crush resistance of the air delivery conduit 4300 and / or reduce the risk of blockage due to buckling of the air delivery conduit 4300.

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

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

[0642] Each of the thickened portions 4315 can correspond to the wider portion of the 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 in Figure 12D includes a circular outer shape 4312 and a non-circular inner shape 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 sections 4315 on opposing sides of the support structure 4310. In this example, the non-circular inner shape 4313 is oval. The thickened sections 4315 are aligned with the minor axis of the oval inner shape 4313 of the support structure 4310. The thickened sections 4315 are formed by increasing the distance between the inner shape 4313 and the outer shape 4312 along the minor axis of the oval inner shape 4313. In addition, the major axis of the ellipse may extend through the thinnest part of the support structure 4310 (i.e., the part of the support structure 4310 where the intermediate surface 4314 is the thinnest).

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

[0645] The support structure 4310 in Figure 12F includes an oval outer shape 4312, an oval inner shape 4313, and a thickened portion 4315. The thickened portion 4315 is provided on opposing sides of the ring member 4315 and faces the oval inner shape 4313 along its major axis. In this example, these thickened portions are formed by the distance between the major axis of the oval inner shape 4313 and the major axis of the oval outer shape 4312. In this example, the ratio of the major axis to the minor axis of the oval inner shape 4313 is smaller than the ratio of the major axis to the minor axis of the oval outer shape 4312. As a result, the thickness of the support structure 4310 becomes uneven around the ring member 4310, with the thickness being greater at the major axis portions of the oval inner and outer shapes.

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

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

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

[0649] The outer shape 4312 of the support structure 4310 may be oval, and the inner shape 4313 may be non-oval (e.g., circular). Figure 12H shows a D-shaped support structure 4310. Figure 8I shows a trapezoidal support structure 4310. Both shapes can also achieve an inconspicuous air delivery conduit 3400. Of course, the shapes of the outer shape 4312 and inner shape 4313 (or inner and outer surfaces) of the support structure 4310 are not limited to these. Note that the outer shape 4312 and inner shape 4313 and the surface 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. In addition, each support structure 4310 may be movable proximal to an adjacent support structure 4310 and distal to an adjacent support structure 4310, so that, for example, the length of the air delivery conduit 4300 can be changed. The longitudinal length of the reinforcing structure 4305 and / or the air delivery conduit 4300 may be adjustable. Furthermore, each support structure 4310 may be movable relative to an adjacent support structure 4310 so that its central longitudinal axis is offset from the central longitudinal axis of the adjacent support structure 4310 and parallel to the central longitudinal axis of the adjacent support structure 4310.

[0651] The spacing between the support structures 4310 can be varied along the length of the air delivery conduit 4300. For example, the support structures 4310 can be further apart from each other 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. This may facilitate cost-effective manufacturing. In another example, the air delivery conduit 4300 includes multiple support structures 4310 of different widths, so that the air delivery conduit 4300 can have different levels of flexibility when bent in different directions.

[0653] In various examples of this technology, the air delivery conduit 4300 may be formed from a plurality of support structures 4310. These support structures 4310 are covered or sealed within a cover material to form a sealed air path.

[0654] 5.5.2 Air-impermeable cover material Figures 13 to 15 show different exemplary configurations of the cover material 4340. In all of these illustrated configurations, the cover material 4340 may include a fabric and may be impermeable. Figures 13 and 14 show the cover material 4340 with a laminated structure. In Figure 13, the laminated structure may include a fabric layer 4347 made of a flexible and / or stretchable woven material (e.g., a woven layer). The laminated material may also include an air-impermeable inner layer (or film) 4348 (e.g., a sealing layer) (attached to the fabric layer 4347 by, for example, joining, bonding, 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. In addition, the woven material may have a knitted structure, a woven structure, or a non-woven structure and may have unidirectional or bidirectional stretch properties. To obtain unidirectional stretch, the fabric may be manufactured and oriented such that the stretch direction is parallel to the longitudinal axis of the air delivery conduit 3400. To obtain bidirectional stretch, the fabric may be manufactured and oriented such that the first stretch direction is parallel to the longitudinal axis of the air delivery conduit and the second stretch direction is perpendicular or perpendicular to the longitudinal axis of the air delivery conduit. In some examples, these stretch properties may be achieved by material adoption (e.g., elastane) or by structure (e.g., knitted 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 improve comfort and feel. For example, the woven material may be brushed, treated with silicone or other types of treatments. The woven material may also be treated to improve properties such as washability, drying properties, stain resistance, dust resistance, and moisture absorption. In addition, the inward-facing side of the woven material (i.e., the side facing the interior of the air-impermeable inner layer 4348 and the air delivery conduit 4300) may be prepared or treated to improve adhesion and / or bonding with the air-impermeable inner layer 4348.

[0657] By using fabric in the cover material 4340, the weight of the air delivery conduit 4300 can be reduced, thereby reducing the drag associated with the air delivery conduit 4300 (which can cause seal instability between the patient interface and the user's face). For example, the surface density of the fabric may be about 250 g / m² (GSM) or less. Preferably, the surface density of the fabric may be less than about 180 g / m² (GSM).

[0658] To achieve local features or functions, including visual appeal, the cover material 4340 is intended to contain more than one type of fabric material. For example, in the cover material 4340, the fabric constituting one area of ​​the fabric layer 4347 may be softer than another type of fabric used in an adjacent area, while the other type of fabric used in the adjacent area may be coarser. Furthermore, by providing a transparent area in the cover material 4340, it is intended that a user may be able to inspect the inside of the air delivery conduit 4300.

[0659] The air-impermeable inner layer 4348 may be installed sandwiched between the fabric material of the fabric layer 4347 and the support structure 4310 of the air delivery conduit 4300. In addition, the air-impermeable inner layer 4348 may be formed from an elastic polymer or elastomer. For example, the air-impermeable inner layer 4348 may be thermoplastic polyurethane (TPU) or 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 cover material 4340 may be formed at least partially of a woven fabric, but 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 avoid situations in which microorganisms or other contaminants grow or are trapped in the fabric and contaminate the pressurized gas flow. Therefore, the surface area of ​​the air-impermeable inner layer 4348 may be larger than the surface area of ​​the fabric material of the fabric layer 4347. In this way, the inner layer 4348 may be sandwiched between the entire fabric material of the fabric layer 4347 and the inner lumen of the air delivery conduit 4300.

[0661] In the configuration shown in Figure 13, the cover material 4340 includes one fabric layer 4347 and one air-impermeable inner layer 4348. In the configuration shown in Figure 14, the cover material 4340 includes multiple fabric layers 4347 and air-impermeable inner layers 4348. The more fabric layers provided, the more flexible the air delivery conduit 4300 can become. In addition, although only two fabric layers 4347 are shown in Figure 11B, the number of fabric layers 4347 is not necessarily limited to two.

[0662] In the configuration shown in Figure 15, the cover material 4340 uses only the fabric layer 4347. The air-impermeable inner layer 4348 in this configuration is omitted. In the configuration without the air-impermeable inner layer 4348, the fabric layer 4347 can be coated with a material that can make the fabric layer 4347 air-impermeable. For example, the fabric layer 4347 can be coated with silicone or a similar material. With this configuration, the bulkiness of the air delivery conduit 4300 can be further reduced by limiting the number of layers forming the cover material 4340.

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

[0664] 5.5.3 End Connectors Referring again to Figure 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 enable the air delivery conduit 4300 to be connected to a flow generator (RPT device) and a patient interface (in a long-pipe configuration). The end connector 4362 may also enable the air delivery conduit 4300 to be connected to a patient interface 3000 and another air delivery conduit (in a short-pipe configuration). It is intended that at least one end connector 4362 may be a swivel joint connection. It is further intended that at least one end connector 4362 may be an elbow connection. It is further intended that at least one end connector 4362 may be a rigid linear connector. Both end connectors 4362 may have the same structure. Alternatively, the end connectors 4362 may have different structures. For example, an end connector 4362 configured to connect to the inlet of a patient interface may take the form of an elbow, and an end connector configured to connect to the outlet of an 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 ventilation assembly, an HMX assembly and / or an asphyxiation prevention assembly.

[0665] 5.5.4 Air delivery conduits Multiple structures 4310 (for example, ring members as shown in Figure 8 or other examples of support structures 4310) can be arranged in a linear pattern (e.g., an array) and then sealed with a cover material to form an air delivery conduit 4300. The air delivery conduit 4300 may include multiple support structures 4310 arranged at intervals along the length of the air delivery conduit 4300, and an air-impermeable cover material 4340 provided on the support structures 4310 along the length of the air delivery conduit 4300, allowing for the transport of airflow during use through the sealed air path formed by the cover material 4340.

[0666] Figure 18 shows multiple support structures 4310 arranged in a sequence. In the air delivery pipe 4300 shown in Figure 19, a cover material 4340 is added to the support structures 4310 shown in Figure 18. In Figure 19, the air delivery pipe 4300 is forcibly curved.

[0667] Multiple support structures 4310, as shown in Figure 20, are arranged in a sequence. In the air delivery pipe 4300 shown in Figure 21, a cover material 4340 is added to the support structure 4310 shown in Figure 20. In Figure 21, the air delivery pipe 4300 is forcibly curved.

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

[0669] The arrangement of the support structures 4310 shown in Figure 18 that form the air delivery tube 4300 shown in Figure 19 is spaced 2 mm apart in the neutral state (e.g., non-extended and non-compressed state), while the arrangement of the support structures 4310 shown in Figure 20 that form the air delivery tube 4300 shown in Figure 21 is spaced 9 mm apart in the neutral state (e.g., non-extended and non-compressed state). The support structures 4310 shown in Figure 18 are narrower than the support structures 4310 shown in Figure 20.

[0670] As shown in Figure 21, the air delivery tube 4300 with wider ring members spaced further apart has greater flexibility than the air delivery tube 4300 shown in Figure 19, which has narrower ring members spaced further apart.

[0671] The spacing between the support structures 4310 and the width of each support structure 4300 may vary between different examples of this technology. In some examples, the spacing between the support structures 4310 is relatively large (e.g., about 9 mm), allowing highly flexible pipes (e.g., those with good drape) to function better as disconnection components (especially when the pipes are short). In other examples, the spacing between the support structures 4310 is relatively narrow (e.g., about 2 mm). This is because shorter spacing reduces bunching of the cover material 4340 between the ring members 4310 and reduces the possibility of misalignment between the support structures 4310, thus reducing the possibility of pipe blockage. In some examples, the spacing between the support structures 4310 is small or medium, but the air delivery pipe 4300 includes a highly flexible and / or stretchable cover material 4340 to impart high flexibility / drape to the air delivery conduit 4300. The spacing between the support structures 4310 and the stretchability of the cover material 4340 can be selected to achieve a predetermined flexibility and / or extensibility of the air delivery conduit 4300.

[0672] In some examples of this technology, the air delivery conduit 4300 includes a plurality of support structures 4300 arranged at intervals of 1 mm to 10 mm. In further examples, the intervals are 2 mm to 6 mm or 2 mm to 3 mm. In some examples, the support structures 4310 of the air delivery conduit 4300 are arranged at intervals of less than 6 mm or less than 3 mm. In some examples, the support structures 4310 include ring members with 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 area within each ring member or other support structure 4310 may be 150 mm² to 200 mm² (e.g., 160 mm² to 185 mm²). In one example, the area within each support structure 4310 is approximately 175 mm². These support structures 4310 may include non-circular shapes (e.g., oval shapes) and include an inner area within the range. This internal surface area allows for the flow of air.

[0673] In some examples of this technology, the air delivery conduit 4300 may have non-uniform flexibility and / or stretchability along the length of the conduit. In some examples, the air delivery conduit 4300 may have different levels of flexibility and / or stretchability between the conduit ends and the conduit middle. For example, the air delivery conduit 4300 may have highly flexible ends and a moderately flexible middle section. Alternatively, in the air delivery conduit 4300, the middle section may have higher flexibility and / or stretchability than the ends. In some examples, the support structures 4310 of a particular air delivery conduit 4300 do not have identical characteristics, geometry, and spacing. In some examples, the air delivery conduit 4300 includes multiple ring members. Some of these multiple ring members include an oval outer shape and some include a circular outer shape, so that a transition is obtained from a circular connector connecting to a long conduit connected to an RPT device at one end to a lower oval connector connecting to a patient interface at the other end. In some examples, in the air delivery conduit 4300, the support structures 4310 are positioned further apart from each other in the central part 4300 than at the ends of the air delivery conduit 4300, or further apart at the ends of the air delivery conduit 4300 than at the ends of the air delivery conduit 4300, so that the flexibility of the air delivery conduit 4300 changes along its length.

[0674] The cover material 4340 for the air delivery conduit may be as described above (for example, the cover material 4340 for the air delivery conduit may be air-impermeable and may include an outer surface formed from a woven material). In some examples, the cover material 4340 takes the form of a laminate. The cover material 4340 may include an outer layer containing a woven material bonded to an air-impermeable inner layer. In some examples, the air-impermeable layer may be formed from a polymer 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, thermoplastic elastomer or other elastomer.

[0675] 5.5.5 Addition of cover material to reinforcing structure According to aspects of this technology, there are multiple methods for attaching the cover material 4340 to the reinforcing structure 4305.

[0676] 5.5.5.1 Reinforcement with cover material: Covering around the structure The cover material 4340 can cover the periphery of the reinforcing structure 4305 and, by joining it to the reinforcing structure 4305, obtain a sealed tubular material including the reinforcing structure. The cover material 4340 can form a sealed air passage. Through this sealed air passage, airflow can be transported by the air delivery conduit 4300 during use. In some examples, the reinforcing structure may include an array of support structures 4310. As shown, in the laminate structure that may be included in the cover material 4340, the outer layer is formed from a woven material and the inner layer is formed from an air-impermeable material (e.g., TPU film). To prevent the woven material from being exposed to the air passage, a sealing layer is provided along the inside of the pipe to seal the edges of the woven layer. This ensures that the air passage is sealed, preventing particles from entering the woven material and preventing any leakage that may occur through the woven layer.

[0677] Figures 22 to 29 show a method for adding a cover material 4340 to a reinforcing structure 4305 including a plurality of support structures 4310 according to an embodiment of the present technology. In this particular example, each support structure 4310 takes the form of a ring member. This method is also applicable when adding a cover material 4340 to another reinforcing structure (for example, one or more helical members extending along the length of the pipe to be formed).

[0678] As shown in Figure 22, multiple support structures 4310 can be arranged in a sequence in a single step. As shown in Figure 23, the support structures 4310 can be supported on a mandrel (or rack) 7000. The support structures 4310 can be aligned concentrically with each other, but can also be spaced apart along the length of the mandrel 7000 and the tubing to be formed.

[0679] As shown in Figure 24, in another step, the sealing layer 4341, taking shape, may be provided on the support structure 4310. In this example, the sealing layer 4341 is a sealing strip. The sealing strip may be added to the reinforcing 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 includes a TPU film and is heat-bondable. Tape may be added to the sealing strip along the reinforcing structure 4305. In other examples, the sealing layer 4341 may be wider than the sealing strip shown in Figure 24, and may cover a larger portion of the periphery or sides of the support structure 4310.

[0680] In some examples, the sealing layer 4341 includes an adhesive layer as an alternative to a heat-bondable layer. In such examples, the adhesive may be biocompatible and can be fully cured during pipe manufacturing.

[0681] Figure 25 shows an end view of the mandrel 7000 and an arrangement of the support structure 4310, where the sealing layer 4341 is added in the form of a sealing strip. The sealing layer 4341 is joined to the support structure 4310 and forms an arc. 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 area around the periphery of the air delivery conduit 4300 to be formed. In some examples, the formation of the sealing layer 4341 may be carried out by winding a sealing strip (e.g., in tape form) helically around the reinforcing structure 4305 at a small angle, so that the sealing strip itself overlaps and completely seals the reinforcing structure 4305. In further examples, the sealing layer 4341 in the form of a sealing sheet may surround the entire periphery of the reinforcing structure 4305, completely sealing the reinforcing structure 4305 with the sealing sheet.

[0683] An air-impermeable cover material 4340 may cover the reinforcing structure 4305 and the sealing layer 4341. In one embodiment, the cover material 4340 may cover the reinforcing structure 4305 and the sealing strip.

[0684] As shown in Figures 26 and 27, in a further step, the outer sheet 4342 covers the periphery of the reinforcing structure 4305. That is, the outer sheet 4342 may be formed as a sheet and then cover the periphery of the reinforcing structure 4305 (for example, as a cylindrical shape) when forming the cover material 4340 for the air delivery conduit 4300. The outer sheet 4342 may not form the outermost layer of the air delivery conduit 4300 and may not provide an exposed outer surface around the air delivery conduit 4300, but may not be "outside" to any other layer of the air delivery conduit 4300 or "outside" to the reinforcing structure 4305. In some examples, the outer sheet 4342 includes a woven material, and in such examples, it 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 added to the reinforcing structure 4305. The outer sheet 4342 also includes a second edge 4342b opposite to the first edge 4342a. The first edge 4342a and the second edge 4342b may be parallel to each other in some examples of the Art, or not 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 the reinforcing structure 4305 may be performed during or after coating around the reinforcing structure 4305 (e.g., by adhesive) or (e.g., by thermal bonding). In this example, the outer sheet 4342 includes an outer portion (facing the periphery of the air delivery conduit 4300 but not necessarily the outermost layer) and an inner portion (facing the axis of the air delivery conduit 4300). In some examples, this inner portion may define at least a portion of a sealed air path within the air delivery conduit 4300.

[0686] In one example, the outer sheet 4342 includes a laminate. The outer sheet 4342 may include an outer layer containing a woven material. The woven material may make the tube feel more comfortable to the touch. The outer sheet 4342 may also include an inner layer containing an air-impermeable material. The air-impermeable material may be bondable to a sealing layer and / or reinforcing structure 4305. The air-impermeable material may include a plastic material, and may 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 other examples, they may be bonded by thermal lamination. In some examples, the outer sheet 4342 may include one or more fabric layers 4347 and one or more air-impermeable layers 4348, as shown in relation to Figures 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 provided outside the woven layer (for example, a film layer provided outside the woven layer).

[0687] As shown in Figures 28 to 30, in a further step, the covering of the reinforcing structure 4305 by the outer sheet 4342 and the bonding of the outer sheet 4342, the sealing layer 4341, and the reinforcing structure 4305 are both completed. The second edge 4342b of the outer sheet 4342 covers the periphery of the reinforcing structure 4305 and passes through the first edge 4342a. After the outer sheet 4342 covers the periphery of the reinforcing structure 4305, the first edge 4342a and the second edge 4342b extend along the air delivery conduit 4300. The inside of the outer sheet 4342 near the second edge 4342b is joined to the outside of the outer sheet 4342 near the first edge 4342a. The second edge 4342b is further joined to the outer surface of the outer sheet 4342, which is adjacent to the first edge 4342a and spaced apart from the first edge 4342a, causing the outer sheets 4342 to overlap. The outer sheets 4342 are used to cover more than 360 degrees around the cross-section of the pipe. Here, an air-impermeable cover material 4340 forms a sealed air path and air delivery conduit 4300. A sealing layer 4341 (a sealing strip in this example) seals the overlapping portion of the outer sheets 4342. By using the outer sheets 4342 to cover each other, a seam may be formed. The seam can be sealed by the sealing layer 4341 (e.g., a sealing strip). 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 serrated shape. The serrated shape may be configured to withstand 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 shapes such as crinkle cut, wavy, serrated, or triangular. These types of shapes can withstand the situation in which the outer sheet 4342 delaminates from itself. If a portion of the second edge 4342b of the outer sheet 4342 with this type of shape begins to delaminate, the likelihood of this delamination propagating along the edge may be reduced compared to the outer sheet 4342 having a straight second edge 4342b.

[0689] In some examples, a single outer sheet 4342 covers the entire length of the reinforcing structure 4305 (for example, the entire length of the air delivery conduit 4300). In other examples, multiple outer sheets 4342 form a cover material 4340. In one example, a first outer sheet 4342 covers the first half of the reinforcing structure 4305, and a second outer sheet 4342 covers the second half of the reinforcing structure 4305. In such examples, the first edges 4342a and second edges 4342b of the first and second outer sheets 4342 extend along the air delivery conduit 4300. However, the first edges 4342a of the first outer sheet 4342 and the second outer sheet 4342 do not have to be collinear with each other. Similarly, the second edge portion 4342b of the first outer sheet 4342 and the second outer sheet 4342 do not have to be collinear with each other.

[0690] The adhesive surface of the outer sheet 4342 at or near the second edge 4342b may also be configured to facilitate 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, roughenings, etc., configured to increase the bonding contact area and bonding strength.

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

[0692] End connectors 4362 (as described with reference to Figure 7A, for example) for connecting the air delivery conduit 4300 between the flow generator and the patient interface (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 therapy device) may be attached in a further step. In one example, the air delivery conduit 4300 includes a first end configured to connect to a tube connected to the outlet of the respiratory pressure therapy 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 the outlet of the respiratory pressure therapy device 4000, and a second end configured to connect to the patient interface 3000.

[0693] Referring to Figure 30, a first portion (or first region) 4343 is provided inside the outer sheet 4342 near the first edge 4342a. Furthermore, a second portion (or first region) 4344 is provided inside the outer sheet 4342 near the first edge 4342a. The first portion 4343 is positioned on the first side of the first edge 4342a, and the second portion 4344 is positioned on the second side of the first edge 4342a. That is, the first portion 4343 and the second portion 4344 are positioned on opposite sides of the first edge 4342a. A sealing layer 4341 (sealing strip in this example) seals the space between the first portion 4343 and the second portion 4344. For example, the sealing layer 4341 can seal the gap between the first portion 4343 and the second portion 4344. In this gap, the outer sheets 4342 overlap. The sealing layer 4341 isolates the outer surface of the outer sheets 4342 from the air path inside the pipe.

[0694] This is particularly advantageous when the outer surface of the outer sheet 4342 is formed from a woven material. This is because, if there is no seal on the first edge 4342a, the woven material forming the outer surface is exposed to the air passage, creating the possibility of gas and / or particles being exchanged between the woven outer surface and the sealed air passage. This also helps to avoid or further prevent microorganisms / bacteria present in the woven layer from reaching the air passage. The sealing layer 4341 isolates the woven layer from the air passage (by adhesion to the air-impermeable inner layer of the outer sheet 4342 provided on either side of the internal overlap between the outer sheets 4342). In this way, the inner surface of the cover material 4340 exposed to the airflow in the pipe is formed only of the sealing material (e.g., plastic (e.g., TPU, TPE, silicone)), and there is no woven layer exposed to the gas flow in the air delivery conduit 4300.

[0695] In another configuration shown in Figure 40A, the inner side of the outer sheet 4342 adjacent to the second edge 4342b is joined to the sealing layer 4341 (in this example, a sealing strip, or in other examples, a sheet or inner tube) (not onto the outside of the outer sheet 4342). The second edge 4342b is in contact with the first edge 4342a to allow for the avoidance of gaps and the provision of the outside of the air delivery conduit 4300, which is substantially formed from the fabric (without causing a thickness doubling due to overlap). The outer layer 4342 covers the periphery of the reinforcing structure, bringing the second edge 4342b of the outer layer 4342 adjacent to the first edge 4342a. In this example, the sealing layer 4341 also seals between the first portion 4343 on the inside of the outer sheet 4342 on the first side of the first edge 4342a and the second portion 4344 on the inside of the outer sheet on the second side of the first edge 4342a. The first portion 4343 is the inner portion of the outer sheet adjacent to the first edge 4342a. In this example, the second portion 4344 is the inner portion of the outer sheet adjacent to the second edge 4342b (adjacent to the first edge 4342a). The sealing layer 4341 seals between the first portion 4343 and the second portion 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 Figure 40B, the first edge 4342a and the second edge 4342b are adjacent to each other. In this configuration, they are sewn together. In this “adjacent” configuration example shown in Figures 40A and 40B, the inner seam formed by the adjacency of the first edge 4342a and the second edge 4342b can be aligned with the sealing layer 4350 so that the fabric layer 4341 of the cover material 4340 is sealed from pressurized breathing gas in the air passage by the sealing layer 4350. In some examples, both the first edge 4342a and the second edge 4342b may be attached to the sealing layer 4350 by, for example, joining, bonding, sewing, weaving, or any other attachment method. The attachment of the first edge 4342a to the second edge 4342b is intended to also be done by, for example, joining, bonding, sewing, weaving, or any other attachment method. It is desirable to align the first edge 4342a and the second edge 4342b with high precision so that they are properly adjacent to each other, thereby avoiding the occurrence of unsightly and / or unpleasant gaps between the first edge 4342a and the second edge 4342b. Note that the first edge 4342a and the second edge 4342b may be serrated as shown in Figure 40B.

[0697] Whether the outer sheet 4342 overlaps with itself or only with the sealing layer 4341, the outer strip 4354 can be joined to the outside of the outer sheet 4342 along the second edge 4342b of the outer sheet 4342. The outer strip 4354 can be joined across the second edge 4342b of the outer sheet 4342 along 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 outside of the joint between the first edge 4342a and the second edge 4342b. The outer strip may include tape and may include woven material. The outer strip may provide sealing in an "overlapping" configuration (e.g., the type shown in Figure 30) across the second edge 4342b of the outer sheet, or in an "adjacent" configuration (e.g., as shown in Figures 40B and 40C) across both the first edge 4342a and the second edge 4342b. The outer strip 4353 may provide additional sealing to the pipe. The outer strip 4354 may be provided at the outer seam / joint of the cover material 4340 of the air delivery conduit 4300 in any example of the art. The outer strip 4354 may also provide a seam with a clean appearance. The color, pattern, and / or structure of the strip may differ from the outer fabric layer of the air delivery conduit 4300. The outer strip 4354 runs along the length of the air delivery conduit 4300 and extends across the first edge 4342a and / or the second edge 4342b of the outer sheet 4342.

[0698] In the example shown in Figure 30, the outer sheet 4342 is joined to the sealing strip 4341, and the first edge 4342a of the outer sheet 4342 is positioned along the sealing strip 4341 near the centerline of the sealing strip. The gap between the first edge 4342a and the inner surface of the outer sheet 4342 to which the first edge 4342a is joined may be the area that benefits from the sealing, and by positioning the first edge 4342a in the center of the sealing strip, the areas of the first portion 4343 and the second portion 4344 on the inner surface of the outer sheet 4342 are maximized on any side of the first edge 4342a to which the sealing strip 4341 may be joined. The inner surface of the outer sheet 4342 near the second edge 4342b is joined to the outer surface of the outer sheet 4342 near the first edge 4342a. Since the second edge portion 4342b is positioned at a distance from the first edge portion 4342a, the outer sheet 4342 overlaps with itself.

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

[0700] As shown in Figures 28-30, the cover material 4340 is joined to itself in the vicinity of the seam. In the examples in Figures 28-30, 40A, and 40C, the cover material is joined to the reinforcing 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 cover material 4340 along the second edge of the cover material 4340. The first and second edges of the cover material 4340 may be serrated. As shown in Figures 28-30, 40A, and 40C, the inside of the seam is aligned with the centerline of the sealing strip.

[0701] Figure 31 shows a method for forming a cover material 4340 by overlapping a sealing layer 4341 and an outer sheet 4342 in another example of an air delivery conduit 4300 according to the present technology. The cover material 4340 is provided on a reinforcing structure 4305. In this example, the reinforcing structure 4305 also includes a plurality of support structures 4310. In this example, the support structures 4310 are ring members, but may have other shapes in other examples of the present technology.

[0702] In this example, the outer sheet 4342 includes a woven material and can therefore 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 cover material 4340 includes 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, it may be provided on only a portion of the woven layer (depending on the specific 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 in the vicinity of the first edge 4342a of the outer layer.

[0704] In this particular example, the sealing flap 4345 covers the first edge 4342a of the outer fabric layer 4342. The sealing flap 4345 seals the portion of the sealing layer 4341 that is bonded to the outer surface of the outer sheet 4342 in the vicinity of the first edge 4342a of the outer sheet 4342.

[0705] As shown in the figure, the sealing flap 4345 seals both the outside of the outer sheet 4342 near the first edge 4342a and the inside of the sealing layer 4341 near the second edge 4342b of the outer sheet 4342. Similar to the example shown in Figure 30, the inside of the outer sheet 4342 includes the first portion 4343 of the first side of the first edge 4342a near the first edge 4342a, and also includes the second portion 4344 of the second side of the first edge 4342a near the first edge 4342a. In this example, the sealing layer 4341 takes the form of a layer laminated onto the outer sheet 4342 and the sealing flap 4345, sealing between the first portion 4343 and the second portion 4344 on the inside of the outer sheet 4342. Therefore, the air path within the air delivery conduit 4300 is sealed and isolated from the woven 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 the flow between the first portion 4343 on the inside of the outer sheet 4342 (e.g., the woven layer) and the second portion 4344 on the inside of the outer sheet 4342 is prevented.

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

[0707] The outer sheet 4342 and the sealing layer 4341 can be assembled with the reinforcing structure 4305 after being laminated together. The sealing flap 4345 can also be assembled with the reinforcing structure 4305 after being covered over the first edge 4342a, so that it is ready to cover the outer sheet 4342 and the sealing layer 4341 near the second edge 4342b of the outer sheet 4342 with the sealing flap 4345 and possibly the outer surface of the outer sheet 4342.

[0708] Figure 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 onto the outer sheet 4342, which is formed from (and may be identified as) a woven material. The sealing layer 4341 also includes a sealing flap 4345. The sealing flap 4345 extends beyond the first edge 4342a of the outer sheet 4342 but does not cover the first edge 4342a. In this example, the sealing flap 4345 seals to 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 bonded to a reinforcing structure 4305. As shown in Figure 30, the inside of the outer sheet 4342 includes a first portion 4343 on the first side of the first edge 4342a adjacent to the first edge 4342a, and a second portion 4344 on the second side of the first edge 4342a adjacent to the first edge 4342a. The sealing layer 4341, together with the integral sealing flap 4345, seals between the first portion 4343 and the second portion 4344. Thus, the sealing flap 4345 seals to another portion 4341 of the sealing layer, preventing leakage between the first portion 4343 and the second portion 4344 on the inside of the outer sheet 4342. Thus, the woven material of the outer sheet 4342 is isolated from the airflow in the air delivery conduit 4300. An advantage of this example of the technology is that no more than four material layers are laminated together at any point around the periphery of the air delivery conduit 4300.

[0709] In examples including 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 further sealing is obtained at the joint between the sealing flap 4345 and the inner surface of the sealing layer 4341 to which it is joined.

[0710] 5.5.5.2 Seamless knit sleeves In further examples of this technology, the cover material 4340 may include a woven sleeve. The woven sleeve may be a knitted sleeve. The knitted sleeve is advantageous because it may include a one-piece structure and therefore does not have seams. The sleeve may be introduced onto a reinforcing structure 4305 (e.g., an arrangement of ring members 4310) and then joined to the reinforcing structure 4305 to form an air delivery conduit 4300. The sealing layer 4341 is joined to the knitted sleeve by expanding an air-impermeable layer (e.g., a sealing layer 4341) within the knitted sleeve.

[0711] In any of the examples of the art described herein, adhesion between a woven material and an air-impermeable material may be achieved by one or more chemical, thermal, 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 Figures 41 and 42, a cover material 4340 is used, which includes an outer layer 4346 in the form of a knitted seamless sleeve. The knitted sleeve may have a seamless tubular structure. The knitting of the cover material 4340 is intended to be carried out using circular knitting, 3D knitting, or any other knitting process capable of producing a seamless tubular structure. In this example, the cover material 4340 also includes a sealing layer 4341. The sealing layer 4341 may be an air-impermeable inner layer that defines a sealed air path. Air can be transported through this sealed air path. The sealing layer 4341 may also be inserted into the knitted sleeve (outer layer 4346) after being formed into a tubular shape. After being inserted into the knitted sleeve, the sealing layer 4341 is inflated so that its outer surface is adjacent to the inner layer of the knitted sleeve. After expansion, the sealing layer 4341 is attached to the knitted sleeve to form the cover material 4340 (e.g., by joining, bonding, sewing, weaving, or any other attachment method). Bonding between the outer layer 4346 and the sealing layer 4341 can be achieved by one or more of the following processes: chemical, thermal, vibration, ultrasonic bonding processes, or any other suitable process.

[0713] Simultaneously, the reinforcing structure 4305 (e.g., an array of support structures 4310) may be positioned on the mandrel (or rack) 7000 in the same manner as the “surrounding” method. The laminated cover material 4340 is slid onto the reinforcing structure 4305 so that the laminated cover material 4340 surrounds or encloses the reinforcing structure 4305. After the laminated cover material 4340 has been slid onto the reinforcing structure 4305, the laminated cover material 4340 may be attached to the reinforcing structure 4305 (e.g., by joining, bonding, sewing, weaving or other arbitrary attachment methods).

[0714] 5.5.5.3 Reversal with Mandrel Support Figure 43 shows a cover material 4340 according to an example of this technology. The cover material 4340 is configured to be used in conjunction with other components (e.g., reinforcing structure 4305) within the air delivery conduit 4300. A method for manufacturing the air delivery conduit 4300 including the cover material 4340 will be described in [reference].

[0715] The cover material 4340 includes an elongated cylindrical shape. In the state shown in Figure 43, the cover material 4340 includes a first side portion that provides the outer surface of the cover material 4340 and a second side portion that provides the inner surface of the cover material 4340. In this example, the cover material 4340 includes a first layer on the first side portion of the cover material 4340 and a second layer on the second side portion of the cover material 4340.

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

[0717] One step in the method for forming the air delivery conduit 4300 includes forming a cover material 4340 in the configuration shown in Figure 43. In one example, the method includes forming the cover material 4340 from a sheet (by joining opposing edges of the sheet). This sheet may be a laminate formed by a first layer and a second layer (e.g., a sealing layer 4341 and an outer layer 4346). In another example, the method includes forming the cover material into an elongated cylindrical shape (by forming the second layer into an elongated cylindrical shape and then providing the first layer outside the second layer). For example, after forming the second layer into an elongated cylindrical shape, the first layer may be coated, sprayed, or otherwise laminated over the outside of the second layer. In one example, the method includes weaving the second layer, for example, by circular weaving or 3D weaving. In some examples of this technology, it should be understood that the cover material 4340 is formed by more than two layers (e.g., three, four or more layers).

[0718] Another step in this method includes supporting a reinforcing structure 4305 on the mandrel 7000. In one embodiment of this technology, the support of the reinforcing structure 4305 on the mandrel 7000 is performed by compressing the mandrel 7000, attaching the reinforcing structure 4305 to the mandrel 7000, and then expanding the mandrel 7000. Figure 44 shows a mandrel 7000 according to an example of this technology. In this example, the mandrel 7000 includes an actuator 7001 and an expansion support 7002. By inserting the actuator 7001 into the expansion support 7002, the mandrel 7000 can be expanded and the expansion support 7002 can be retracted, causing the mandrel 7000 to buckle. Figure 44 shows the mandrel 7000 in a compressed state. In this state, the reinforcing structure 4305 can be attached to the mandrel 7000 by mounting it on the expanded support portion 7002. As shown in Figure 45, the reinforc...

Claims

1. An air delivery conduit configured to deliver airflow under pressure from a respiratory pressure therapy device to a patient interface in order to provide respiratory pressure therapy to a patient, wherein the air delivery conduit is It includes a fabric layer formed from a woven fabric, and the fabric layer is A first portion formed from a first fiber network of a fabric, wherein the first portion has a first rigidity, A second portion comprising at least one second portion formed from a second fiber network of a fabric, the second portion being treated by a hardening process to have a second rigidity higher than a first rigidity, An air delivery conduit that enables the transport of airflow during use through a sealed air path formed by the air delivery conduit.

2. The air delivery conduit according to claim 1, wherein the fabric layer includes an active material provided in a second portion, and the second portion is cured by the active material after a curing process.

3. The air delivery conduit according to claim 2, wherein the first fiber network comprises a first material, and the second fiber network comprises the active material.

4. The air delivery conduit according to any one of claims 1 to 3, wherein the curing process comprises heat treatment, photoactivation treatment, pressure activation treatment, or chemical activation treatment.

5. It is a patient interface assembly: A patient interface configured to engage tightly with the patient's face during use, Includes an air delivery conduit according to any one of claims 1 to 4, A patient interface assembly in which the air delivery conduit is connected to or can be connected to the patient interface to deliver pressurized respiratory gas to the patient interface.

6. A respiratory therapy system configured to deliver pressurized respiratory gas to a patient's airway, A respiratory therapy device configured to pressurize the flow of respiratory gases, Includes an air delivery conduit according to any one of claims 1 to 4, The air delivery conduit is connected to or can be connected to the respiratory therapy device in a patient interface assembly so as to receive the pressurized respiratory gas flow from the respiratory therapy device.

7. A method for manufacturing an air delivery conduit configured to deliver airflow under pressure from a respiratory pressure therapy device to a patient interface in order to provide respiratory pressure therapy to a patient, To form a fabric layer for the air delivery conduit, wherein the fabric layer includes at least one first portion formed from a first fiber network and at least one second portion formed from a second fiber network. This includes performing a hardening process on a second portion of the fabric layer to give the second portion higher rigidity than the first portion of the fabric layer, A method that enables the transport of airflow during use through a sealed air path formed by the aforementioned air delivery conduit.

8. The method according to claim 7, wherein the method comprises weaving or knitting the fabric layer.

9. The method according to claim 8, further comprising weaving or knitting the circular fabric layer.

10. The method according to claim 8, wherein the method comprises knitting the fabric layer horizontally.

11. The method according to any one of claims 7 to 10, comprising providing an activated material to a second portion of the fabric layer, wherein the second portion is cured by a curing process due to the activated material.

12. The method according to claim 11, further comprising providing the activated material to a second portion of the fabric layer after forming the fabric layer.

13. The method according to any one of claims 11, further comprising providing more than one of the activated materials to the second portion of the fabric layer.

14. The method according to claim 13, wherein the activated material is more easily curable than the first material.

15. The method according to any one of claims 7 to 10, wherein the curing process includes performing a heat treatment, curing the fibers of the fabric layer, performing a photoactivation process, applying pressure to the second part, generating a chemical reaction, or providing one or more materials for generating a chemical reaction.

16. The method of claim 15, wherein the method includes heat-treating the fabric layer in the step of adhering the sealing layer to the fabric layer.

17. The method according to claim 16, further comprising supporting the sealing layer on a balloon of a mandrel, expanding the sealing layer by inflating the balloon with hot air, and joining the sealing layer to the fabric layer.

Images