Headband tube for patient interface

Abstract

A patient interface for treating sleep disorder breathing includes a headband tube that provides support for a seal-forming structure. The headgear tube includes a patient-contacting portion and a non-patient-contacting portion joined along a seam to form a gas passage. The headgear tube may include a fabric material and / or a foam material. Portions of the headgear tube may be imparted greater stiffness than other portions.

Description

[0001] This application is a divisional application of invention patent application number 201980094588.2, filed on December 4, 2019, and entitled “Headband Tube for Patient Interface.” Invention patent application 201980094588.2 is an application entering the Chinese national phase of PCT international application No. PCT / IB2019 / 060432.

[0002] 1 Cross-reference to related applications

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 821,878, filed March 21, 2019, and also claims the benefit of Australian Provisional Application Nos. AU2019900260, filed January 29, 2019, AU2019901040, filed March 28, 2019, AU2019901041, filed March 28, 2019, AU2019901043, filed March 28, 2019, AU2019901459, filed April 30, 2019, and AU2019901847, filed May 29, 2019, the entire contents of each of which are incorporated herein by reference. 2 Background Technology 2.1 Technical Field

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

[0005] Certain forms of the present technology relate to patient interfaces for treating breathing, preventing, and ameliorating breathing-related conditions.

[0006] 2.2 Description of Related Technologies

[0007] 2.2.1 Human respiratory system and its diseases

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

[0009] The airways include a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and allowing carbon dioxide to move in the opposite direction. The trachea is divided into the left and right main bronchi, which are ultimately divided into terminal bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Further branches of the airways lead to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is the area where gas exchange occurs and is called the respiratory zone. Referring to " Respiratory Physiology (Respiratory Physiology)" published by John B.West, Lippincott Williams & Wilkins in 2012, the 9th edition.

[0010] There is a range of respiratory disorders. Some disorders can be characterised by specific events such as apnea, hypopnea and hyperpnea.

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

[0012] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events including occlusion or obstruction of the upper airway during sleep. It is caused by a combination of an abnormally small upper airway and normal loss of muscle tone in the tongue, soft palate, and posterior oropharyngeal wall area during sleep. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can cause cardiovascular disease and brain damage. The syndrome is a common disease, especially in middle-aged overweight men, but the people affected may not be aware of this problem. Referring to U.S. Patent No. 4,944,310 (Sullivan).

[0013] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is an obstruction of the patient's respiratory controller, in which there is a rhythmic alternating cycle of boom-and-bust ventilation called a CSR cycle. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. CSR may be harmful due to repetitive hypoxia. In some patients, CSR is associated with repeated awakenings from sleep, which leads to severe sleep disruption, increased sympathetic nerve activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0014] Respiratory failure is an umbrella term for respiratory diseases in which the lungs cannot take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following conditions.

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

[0016] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia during wakefulness, in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headaches, and excessive daytime sleepiness.

[0017] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common features. These include increased resistance to air movement, a prolonged expiratory phase of breathing, and a loss of the lungs' normal elasticity. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: dyspnea on exertion, a chronic cough, and sputum production.

[0018] Neuromuscular disease (NMD) is a broad term that encompasses many diseases and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage, which leads to loss of the ability to walk, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular diseases can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disease: characterized by muscle damage that worsens over several months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents; (ii) variable or slowly progressive disease: characterized by muscle damage that worsens over several years and only slightly shortens life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, dysphagia, dyspnea during exercise and at rest, fatigue, drowsiness, morning headaches, and difficulty concentrating and mood changes.

[0019] Chest wall diseases are a group of thoracic deformities that result in inefficient connections between the respiratory muscles and the thorax. These diseases are often characterized by restrictive defects and have the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0020] A range of treatments have been used to treat or ameliorate these conditions. Furthermore, such treatments can be used to prevent breathing problems in otherwise healthy individuals. However, these have a number of drawbacks.

[0021] 2.2.2 Treatment

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

[0023] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA treated with CPAP can be voluntary, so if a patient finds the device used to provide such treatment to be any one or more of: uncomfortable, difficult to use, expensive, and unsightly, the patient may choose not to comply with the treatment.

[0024] Non-invasive ventilation (NIV) provides ventilation support to the patient through the upper airway to assist the patient's breathing and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, such as OHS, COPD, NMD, and chest wall disease. In some forms, the comfort and effectiveness of these treatments can be improved.

[0025] Non-invasive ventilation (IV) provides ventilation support to patients who are unable to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0026] 2.2.3 Treatment system

[0027] These therapies can be provided by therapeutic systems or devices.Such systems and devices can also be used to diagnose a condition without treating the condition.

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

[0029] 2.2.3.1 Patient interface

[0030] The patient interface can be used to couple the respiratory apparatus to its wearer, for example, by providing a flow of air to the entrance of the airway. The flow of air can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area of ​​the patient's face, for example, to facilitate delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to deliver gas at a positive pressure of approximately 10 cmH2O to the airway.

[0031] Certain other mask systems may not be functionally suitable for this application. For example, a purely cosmetic mask may not be able to maintain adequate pressure. A mask system used for underwater swimming or diving may be configured to prevent the ingress of water from a higher external pressure, but will not maintain the internal air at a pressure higher than the ambient pressure.

[0032] Certain masks may be clinically unsuitable for this technology, for example if they block airflow through the nose and only allow it through the mouth.

[0033] Certain masks may be uncomfortable or impractical with the present technology if the patient is required to insert a portion of the mask structure in their mouth to create and maintain a seal with their lips.

[0034] Certain masks may be impractical to use while sleeping, such as when lying on your side in bed with your head on a pillow.

[0035] Designing a patient interface presents many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly between individuals. Because the head is composed of bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. And the entire head can move during respiratory therapy.

[0036] As a result of these challenges, some masks suffer from one or more problems of being prominent, aesthetically undesirable, expensive, poorly fitting, difficult to use, and uncomfortable, particularly when worn for extended periods of time or when the patient is unfamiliar with the system. A mask of the wrong size may lead to reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks used for the administration of anesthetics may be tolerable for their original applications, but nonetheless, such masks may be undesirably uncomfortable when worn for extended periods of time (e.g., several hours). This discomfort may lead to reduced patient compliance with treatment. This is even more true if the mask is worn during sleep.

[0037] CPAP therapy is highly effective in treating certain respiratory conditions, provided the patient adheres to the treatment. If the mask is uncomfortable or difficult to use, the patient may not adhere to the treatment. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean their mask, which may affect patient compliance.

[0038] While a mask used for other applications (such as navigators) may not be suitable for treating sleep-disordered breathing, a mask designed to treat sleep-disordered breathing may be suitable for other applications.

[0039] For these reasons, patient interfaces for delivering CPAP during sleep have emerged as a distinct field.

[0040] 2.2.3.1.1 Sealing structure

[0041] The patient interface may include a seal-forming structure. Since it is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

[0042] The patient interface may be characterized in part based on the design intent of the seal-forming structure to engage with the face during use. In one form of the patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left nostril and a second sub-portion that forms a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils when in use. Such a single element may be designed to cover, for example, the upper lip region and the bridge of the nose region of the face. In one form of the patient interface, the seal-forming structure may include an element that surrounds the mouth region when in use, for example, by forming a seal on the lower lip region of the face. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth region when in use. These different types of patient interfaces may be referred to by various names by their manufacturers, including nasal masks, full face masks, nasal pillows, nasal sprays, and oronasal masks.

[0043] A seal-forming structure that is effective in one area of ​​a patient's face may be inadequate in another area, e.g., due to different shapes, structures, variability, and sensitive areas of the patient's face. For example, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on the patient's nose.

[0044] Certain seal-forming structures can be designed for mass manufacturing so that one design fits and is comfortable and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-manufactured patient interface, one or both must be modified to form a seal.

[0045] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface with the seal-forming structure in facing engagement with the patient's face. The seal-forming structure may include an air or fluid-filled cushion, or a molded or formed surface of a resilient sealing element made of an elastomer (e.g., rubber). With this type of seal-forming structure, if the fit is inadequate, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0046] Another type of seal-forming structure incorporates a sheet of thin material located around the perimeter of the mask to provide a self-sealing effect against the patient's face when positive pressure is applied within the mask. Similar to the previous types of seal-forming portions, if the fit between the face and the mask is poor, excessive force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or bend during use, causing leaks.

[0047] Another type of seal-forming structure may include friction-fit elements, for example for insertion into a nostril, however some patients find these uncomfortable.

[0048] Another form of seal-forming structure can use adhesive to achieve the seal.Some patients may find it inconvenient to frequently apply and remove adhesive from their face.

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

[0050] One form of nasal pillow is found in the Adam circuit manufactured by Puritan-Bennett. Another type of nasal pillow or nasal spray is the subject of US Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0051] ResMed Limited manufactures the following products that incorporate nasal pillows: SWIFT™ Nasal Pillows, SWIFT™ II Nasal Pillows, SWIFT™ LT Nasal Pillows, SWIFT™ FX Nasal Pillows, and MIRAGE LIBERTY™ Full Face Mask. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: International Patent Application WO 2004 / 073778 (describing the ResMed Limited SWIFT™ Nasal Pillows) TM Other aspects of the nasal pillow), U.S. Patent Application 2009 / 0044808 (describing ResMed Limited SWIFT TM LT nasal pillows); International Patent Applications WO 2005 / 063328 and WO 2006 / 130903 (describing the ResMed Limited MIRAGE LIBERTY TM Other aspects of full face masks); International patent application WO 2009 / 052560 (describing the ResMed Limited SWIFT TM Other aspects of the FX Nasal Pillows).

[0052] 2.2.3.1.2 Positioning and stabilization

[0053] The seal-forming structure of the patient interface for positive air pressure therapy is subjected to the corresponding force of air pressure to destroy the seal. Therefore, various technologies have been used to position the seal-forming structure and keep it in a sealing relationship with the appropriate part of the face.

[0054] One technique is to use adhesives. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0055] Another technique is to use one or more straps and / or stabilizing braces. Many of these braces suffer from one or more problems of being ill-fitting, bulky, uncomfortable, and inconvenient to use. When designed to be worn on a patient's head, such a brace may be referred to as a headgear.

[0056] 2.2.3.1.3 Pressurized air duct

[0057] In one type of therapy system, a pressurized air flow is provided to the patient interface through a conduit in an air circuit fluidly connected to the patient interface, such that when the patient interface is positioned on the patient's face during use, the conduit extends forwardly out of the patient interface, away from the patient's face. This may sometimes be referred to as an "elephant trunk" type interface.

[0058] Some patients find such interfaces unsightly and are reluctant to wear them, which reduces patient compliance. In addition, the tubing connected to the interface on the front of the patient's face can sometimes become easily entangled in bedding.

[0059] 2.2.3.1.4 Pressurized air ducts for positioning / stabilizing seal-forming structures

[0060] An alternative type of treatment system that seeks to address these problems includes a patient interface in which the tube that delivers pressurized air to the patient's airway also serves as part of a headgear to position and stabilize the seal-forming portion of the patient interface to the appropriate portion of the patient's face. This type of patient interface may be referred to as a combined "headgear tube" or "conduit headgear." Such a patient interface allows the conduit in the air circuit that provides the pressurized air flow from the respiratory pressure therapy device to be connected to the patient interface at a location other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication No. US2007 / 0246043, the contents of which are incorporated herein by reference, in which the conduit is connected to the tube in the patient interface via a port that is positioned on the top of the patient's head during use.

[0061] Philips DreamWear TM The nasal mask includes such a headband tube. One problem with this mask is that the headband tube is made of silicone. The silicone tube can cause discomfort to the patient when it rests against the patient's face. In addition, the weight of the headband may cause some patients to feel uncomfortable during use.

[0062] Patient interfaces incorporating headgear tubes may provide some advantages, such as avoiding conduits connected to the patient interface in front of the patient's face, which may be unsightly and obtrusive. However, patient interfaces incorporating headgear tubes may be comfortable for the patient while the patient is sleeping while being worn for extended periods of time while forming an effective seal with the patient's face.

[0063] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

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

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

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

[0067] Table of noise output levels of existing RPT devices (one sample only, measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744).

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

[0069] One known RPT device for treating sleep-disordered breathing is the S9 sleep therapy system manufactured by ResMed. Another example of an RPT device is a ventilator. Ventilators, such as the ResMed Stellar ventilator for adults and pediatrics, TM The company's portfolio of ventilators can provide invasive and non-invasive non-dependent ventilatory support to a range of patients to treat a variety of conditions such as, but not limited to, NMD, OHS, and COPD.

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

[0071] The designer of a device may be provided with an infinite number of choices that can be made. Design criteria often conflict, which means that some design choices are far from conventional or unavoidable. In addition, some aspects of comfort and efficacy may be highly sensitive to small subtle changes in one or more parameters.

[0072] 2.2.3.3 Humidifier

[0073] Delivering an airstream without humidification can lead to airway dryness. Using a humidifier with an RPT device and patient interface produces humidified air that minimizes drying of the nasal mucosa and increases patient airway comfort. Furthermore, in colder climates, warm air, often applied to the facial area in and around the patient interface, is more comfortable than cold air. Therefore, humidifiers typically have the ability to both heat the airstream and humidify it.

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

[0075] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to the ambient air when needed, typically where a patient may be asleep or resting (e.g., in a hospital). Medical humidifiers for bedside placement can be very small. A medical humidifier can be configured to humidify and / or heat only the air stream delivered to the patient, without humidifying and / or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers), for example, can also humidify the air that the patient breathes, however these systems also humidify and / or heat the entire room, which can cause discomfort to the occupants. In addition, medical humidifiers may have more stringent safety restrictions than industrial humidifiers.

[0076] Although many medical humidifiers are known, they may have one or more disadvantages. Some medical humidifiers may provide inadequate humidification, and some may be difficult or inconvenient to use by patients.

[0077] 2.2.3.4 Data Management

[0078] There may be a clinical reason for obtaining data to determine whether a patient prescribed a respiratory therapy has been "compliant," e.g., that the patient has used their RPT device according to one or more "compliance rules." One example of a compliance rule for CPAP therapy is a requirement that, in order to be considered compliant, a patient use the RPT device for at least four hours a night on at least 21 of 30 consecutive days. To determine patient compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing the use of the RPT device for the patient's treatment, calculate usage over a predetermined time period, and compare to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device according to the compliance rules, the healthcare provider may inform the patient of the third component of compliance.

[0079] There may be other aspects of patient treatment that would benefit from the communication of treatment data to a third party or external system.

[0080] Existing processes for communicating and managing such data can be one or more of expensive, time consuming, and error prone.

[0081] 2.2.3.5 Mandibular reduction

[0082] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from a dentist or other supplier that holds the lower jaw (mandible) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before going to sleep and removes it after sleep. Therefore, an MRD is not designed to be worn all the time. An MRD can be custom made or produced in a standard form and includes a bite-impression portion designed to allow it to fit over the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, applies tension on the pharyngeal walls to reduce collapse of the airway and reduces palatal vibrations.

[0083] In some examples, a mandibular advancement device may include an upper plate designed to engage or cooperate with teeth on the maxilla or maxilla, and a lower plate designed to engage or cooperate with teeth on the maxilla or mandible. The upper and lower plates are laterally connected by a pair of connecting rods. The pair of connecting rods are symmetrically secured to the upper and lower plates.

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

[0085] Some MRDs are constructed to push the mandible forward relative to the maxilla, whereas other MADs (e.g., ResMed Narval CC TM The MRD) is designed to hold the mandible in a forward position. The device also reduces or minimizes side effects on the teeth and the temporomandibular joint (TMJ). Therefore, it is constructed to minimize or prevent any movement of one or more teeth.

[0086] 2.2.3.6 Vent Technology

[0087] Some forms of patient interface systems may include a vent to allow flushing of exhaled carbon dioxide. The vent may allow gas to flow from an interior space (eg, a plenum) of the patient interface to a space external to the patient interface, such as to the environment.

[0088] The vent may include an orifice through which gas can flow when the mask is in use. Many such vents are noisy. Others may become clogged during use and thus provide inadequate flushing. Some vents may disrupt the sleep of the patient's 1000 bed partner 1100, for example, by making noise or by converging airflow.

[0089] ResMed Limited has developed a number of improved mask ventilation technologies, see International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent Application No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0090] Noise table of existing masks (ISO 17510-2:2007, 10cmH2O pressure 1m)

[0091]

[0092] (*One sample only, measured using the test method specified in ISO 3744 in CPAP mode at 10 cmH2O)

[0093] The sound pressure values ​​for various objects are listed below

[0094]

[0095] 2.2.4 Screening, diagnosis and monitoring systems

[0096] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and usually involves clinical experts to apply the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep-disordered breathing involves observing the patient for two nights in the clinic, one night for pure diagnosis and the second night for clinician titration of treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

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

[0098] A clinical specialist may be able to adequately screen, diagnose, or monitor a patient based on visually observed PSG signals. However, there are situations where a clinical specialist may not be available or may not be affordable. Different clinical specialists may disagree on a patient's condition. Furthermore, a given clinical specialist may apply different criteria at different times. 3 Summary of the invention

[0099] The present technology is intended to provide medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders with improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0100] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0101] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0102] One aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0103] One form of the present technology includes a patient interface for delivering a supply of pressurized breathable gas to an entrance to the airway of a patient.

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

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

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

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

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

[0109] Another aspect of one form of the present technology includes a patient interface. The patient interface may include a plenum chamber that is pressurizable to a therapeutic pressure that is at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum inlet port sized and configured to receive a flow of air at a therapeutic pressure for breathing by the patient. The patient interface may include a seal-forming structure configured and arranged to form a seal with a patient's facial region surrounding an entrance to the patient's airway. The seal-forming structure may have apertures therein such that the flow of air at the therapeutic pressure is delivered to at least one entrance to the patient's nares. The seal-forming structure may be configured and arranged to, during use, maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle. The patient interface may include at least one gas delivery tube for delivering the flow of air to the entrance to the patient's airway via the seal-forming structure, the at least one gas delivery tube configured and arranged to, during use, contact at least one region of the patient's head above a supra-auricular base of the patient's head. The at least one gas delivery tube may include an inner fabric layer and an outer fabric layer. The outer fabric layer may have a predetermined non-planar cross-sectional shape. The outer fabric layer may be elastic such that when subjected to an external force, the cross-sectional shape of the outer fabric layer changes, and when the external force is released, the outer layer returns to the predetermined non-planar cross-sectional shape.

[0110] In examples, (a) the inner fabric layer can have different material properties than the outer fabric layer, (b) the inner fabric layer can include an inner fabric membrane, wherein the inner fabric membrane is configured to allow air to pass through the inner fabric membrane when pressurized with air during use, (c) the inner fabric layer can include a compliant inner fabric membrane and the outer fabric layer can include a compliant outer fabric membrane, wherein the outer fabric layer is thicker than the inner fabric layer, (d) the inner fabric layer can have a substantially planar cross-section, (e) the inner fabric layer can be floppy, (f) the inner fabric layer can be secured to the outer fabric layer, wherein the outer fabric layer applies tension to the inner fabric layer, and (g) the inner fabric layer can be affixed to the outer fabric layer. The layer may include an outer fabric sheet and an inner fabric membrane, wherein the inner fabric membrane is configured to resist transfer of air through the outer fabric sheet, (h) at least one gas delivery tube may be configured to extend continuously from the right side of the patient along the parietal bone to the left side of the patient, (i) the at least one gas delivery tube may include an air supply conduit, wherein the air supply conduit is positioned adjacent the parietal bone when the patient interface is worn by the patient, j) the outer fabric layer may include an outer fabric sheet and an inner fabric membrane, wherein a compliant sheet is sandwiched between the outer fabric sheet and the inner fabric membrane, (k) the inner fabric layer may be joined to the outer fabric layer at a joint, wherein the width of the joint varies along the length of the at least one gas delivery tube, (l) the outer fabric layer has an inner surface, wherein the inner surface of the outer fabric layer may have a positive curvature, (m) the inner fabric layer may have a zero curvature, (n) the inner fabric layer and the outer fabric layer may be joined together without sewing, (o) the inner fabric layer may include an inner inner fabric membrane, wherein the outer fabric layer may include an outer inner fabric membrane, wherein the outer inner fabric membrane of the outer fabric layer and the inner inner fabric membrane of the inner fabric layer are joined together along an edge of the at least one gas delivery tube, wherein the inner inner fabric membrane and the outer inner fabric membrane join the inner fabric layer to the outer fabric layer and form an airtight membrane between the inner fabric layer and the outer fabric layer, (p) the inner fabric layer and the outer fabric layer may The gas delivery tube may be configured to be joined at a first edge by a first joint and connected at a second edge by a second joint, and spaced apart from each other between the first joint and the second joint, wherein no rigid members are used along the inner fabric layer between the first joint and the second joint, (q) during use and by air pressurization, the inner fabric layer can expand away from the outer fabric layer, (r) the outer fabric layer can include a compliant material, wherein the compliant material is thermoformed into the non-planar cross-sectional shape, and (s) the at least one gas delivery tube can be thermoformed into a predetermined shape so that the first arm extends along a first plane and the upper portion extends along a second plane, and the second plane is substantially perpendicular to the first plane in the absence of external force or pressure.

[0111] Another aspect of one form of the present technology includes a patient interface. The patient interface may include a plenum chamber that is pressurizable to a therapeutic pressure that is at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum inlet port sized and configured to receive a flow of air at a therapeutic pressure for breathing by the patient. The patient interface may include a seal-forming structure configured and arranged to form a seal with a patient's facial region surrounding an entrance to the patient's airway. The seal-forming structure may have an aperture therein such that the flow of air at the therapeutic pressure is delivered to at least one entrance to the patient's nares. The seal-forming structure may be configured and arranged to, in use, maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle. The patient interface may include at least one gas delivery tube to deliver the flow of air to the entrance to the patient's airway via the seal-forming structure, the at least one gas delivery tube configured and arranged to, in use, contact at least one region of the patient's head above a supraauricular base point of the patient's head. The at least one gas delivery tube may include an inner fabric layer and an outer fabric layer, wherein the inner fabric layer and the outer fabric layer may be connected along a first longitudinal edge at a first joint and along a second longitudinal edge at a second joint. The outer fabric layer may be spaced apart from the inner fabric layer between the first joint and the second joint. The outer fabric layer may support its own weight between the first joint and the second joint such that the outer fabric layer remains spaced apart from the inner fabric layer when not supported by pressurized air.

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

[0113] Another aspect of one form of the present technology includes a patient interface. The patient interface may include a plenum chamber that is pressurizable to a therapeutic pressure that is at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum inlet port sized and configured to receive a flow of air at a therapeutic pressure for breathing by the patient. The patient interface may include a seal-forming structure configured and arranged to form a seal with a patient's facial region surrounding an entrance to the patient's airway. The seal-forming structure may have apertures therein such that the flow of air at the therapeutic pressure is delivered to at least one entrance to the patient's nares. The seal-forming structure may be configured and arranged to, during use, maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle. The patient interface may include at least one gas delivery tube for delivering the flow of air to the entrance to the patient's airway via the seal-forming structure, the at least one gas delivery tube configured and arranged to, during use, contact at least one region of the patient's head above a supra-auricular base point of the patient's head. The at least one gas delivery tube may include an inner fabric layer and an outer fabric layer, wherein the outer fabric layer is more rigid than the inner fabric layer. The inner fabric layer and the outer fabric layer may be connected along the first longitudinal edge and the second longitudinal edge.An air passage may be formed between the inner fabric layer and the outer fabric layer.

[0114] In an example according to the preceding paragraph, (a) the outer fabric layer may have a predetermined non-planar cross-sectional shape, and wherein the outer fabric layer may be elastic such that the shape of the outer fabric layer changes when subjected to an external force, (b) the outer fabric layer may be spaced apart from the inner fabric layer between the first longitudinal edge and the second longitudinal edge; and wherein the outer fabric layer may support its own weight between the first longitudinal edge and the second longitudinal edge such that the outer fabric layer remains spaced apart from the inner fabric layer when not supported by pressurized air, (c) the inner fabric layer may include an inner fabric membrane, wherein the inner fabric membrane is configured to allow air to pass through the inner fabric membrane when pressurized with air during use, and (d) the inner fabric layer The patient interface may include a conformable inner fabric membrane, and the outer fabric layer may include a conformable outer fabric membrane, wherein the outer fabric layer may be thicker than the inner fabric layer, (e) the inner fabric layer may have a substantially planar cross-section, (f) the inner fabric layer may be flexible, (g) the inner fabric layer may be secured to the outer fabric layer, wherein the outer fabric layer may apply tension to the inner fabric layer, (h) the inner fabric layer may include an outer fabric sheet and an inner fabric membrane, wherein the inner fabric membrane may be configured to prevent air from passing through the outer fabric sheet, (i) the at least one gas delivery tube may be configured to extend continuously from the right side of the patient along the parietal bone to the left side of the patient, (j) the at least one gas delivery tube may include an air supply conduit, wherein when the patient interface is worn by the patient, The air supply conduit is positioned adjacent to the parietal bone, (k) the outer fabric layer may include an outer fabric sheet and an inner fabric membrane, wherein a compliant sheet is sandwiched between the outer fabric sheet and the inner fabric membrane, (l) the inner fabric layer may be joined to the outer fabric layer at a joint, wherein the width of the joint varies along the length of at least one gas delivery tube, (m) the outer fabric layer has an inner surface, wherein the inner surface of the outer fabric layer may have a positive curvature between a first longitudinal edge and a second longitudinal edge, (n) the inner fabric layer may have a zero curvature between the first longitudinal edge and the second longitudinal edge, (o) the inner fabric layer and the outer fabric layer may be joined together without stitching, (p) the inner fabric layer may include an inner inner fabric membrane, wherein the outer The fabric layer may include an outer inner fabric membrane, wherein the outer inner fabric membrane of the outer fabric layer and the inner inner fabric membrane of the inner fabric layer may be joined together along an edge of the at least one gas delivery tube, wherein the inner inner fabric membrane and the outer inner fabric membrane join the inner fabric layer to the outer fabric layer and form an airtight membrane between the inner fabric layer and the outer fabric layer, (q) the inner fabric layer and the outer fabric layer are joined at a first edge by a first joint and at a second edge by a second joint and are spaced apart from each other between the first joint and the second joint, wherein no rigid member is used along the inner fabric layer between the first joint and the second joint, (r) during use and by air pressurization,The inner fabric layer may expand away from the outer fabric layer, (s) the patient interface may be configured to allow the patient to breathe from the surrounding environment through their mouth without pressurized air flow through the plenum inlet port, or the patient interface may be configured such that the patient's mouth is uncovered, (t) the plenum may be constructed of a transparent material, (u) the patient interface may be configured such that no portion of the patient interface enters the mouth during use, (v) the patient interface may be configured such that the seal-forming structure does not extend under the metal ridge area during use, (w) the patient interface may be constructed and arranged such that the plenum does not cover the eyes during use, (x) the patient interface may be configured such that the positioning and stabilizing structure provides a retention force of at least (6 (gf / cm2) × mask footprint (cm2)) during use, (y) the patient interface may be configured such that the positioning and stabilizing structure provides a force of less than (30 (gf / cm2) × mask footprint (cm2)) during use, (z) a portion of the positioning and stabilizing structure may be configured to be breathable to allow moisture vapor to escape and / or be transmitted therethrough.

[0115] Another aspect of the present technology relates to a patient interface comprising: an inflatable chamber; a seal-forming structure; a vent structure; and a positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on a patient's head. The positioning and stabilizing structure includes at least one gas delivery tube to receive an air flow from a connection port and deliver the air flow to an entrance to the patient's airway via the seal-forming structure, the gas delivery tube being constructed and arranged to contact, during use, a region of the patient's head at least above a supra-auricular base point of the patient's head.

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

[0117] Another aspect of the present technology relates to a positioning and stabilizing structure that provides a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head. The seal-forming structure is constructed and arranged to form a seal around an area of ​​the patient's face surrounding an entrance to the patient's airway, for use in sealingly delivering a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilizing structure may include at least one gas delivery tube to receive a flow of air from a connection port at the top of the patient's head and deliver the flow of air to the entrance of the patient's airway via the seal-forming structure. The gas delivery tube is constructed and arranged to contact, during use, a region of the patient's head at least above a supra-auricular base of the patient's head. The gas delivery tube includes a tube wall defining a hollow interior through which air can flow to the seal-forming structure. The tube wall may include 1) a non-patient contacting portion comprising a first outer layer and a first inner layer comprising an air-impermeable material; and 2) a patient contacting portion comprising a second outer layer configured to be placed against the patient's head on a side of the gas delivery tube opposite the first outer layer during use, and a second inner layer comprising an air-impermeable material.

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

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

[0120] In further examples: (a) the front edges are joined to form a front seam of the gas delivery tube, and the rear edges are joined to form a rear seam of the gas delivery tube; (b) the front seam and / or the rear seam are thermoformed; (c) the gas delivery tube includes an eyelet configured to be connected to a back strap of the positioning and stabilizing structure; (d) the eyelet is formed by the patient contacting portion and / or the non-patient contacting portion; and / or (e) the eyelet is formed by a seam connecting the rear edges of the patient contacting portion and the non-patient contacting portion.

[0121] According to another aspect of the present technology, a positioning and stabilizing structure is provided that provides a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head. The seal-forming structure is configured and arranged to form a seal around an area of ​​the patient's face surrounding an entrance to the patient's airway, for use in sealingly delivering a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilizing structure may include at least one gas delivery tube to receive a flow of air from the top of the patient's head and deliver the flow of air to the entrance of the patient's airway via the seal-forming structure. The gas delivery tube is configured and arranged to contact, during use, an area of ​​the patient's head at least above a supra-auricular base of the patient's head. The gas delivery tube includes a tube wall defining a hollow interior through which air can flow to the seal-forming structure. The tube wall may include 1) an elongated patient contacting portion configured to rest against the patient's head during use; and 2) an elongated non-patient contacting portion on a side of the gas delivery tube opposite the patient contacting portion, wherein the non-patient contacting portion is drawn into a predetermined shape by the patient contacting portion to form the hollow interior of the gas delivery tube.

[0122] In embodiments: (a) the gas delivery tube is biased toward an open configuration; (b) the non-patient contacting portion is biased toward a flat shape; (c) the non-patient contacting portion is biased by elasticity in one or more materials forming the non-patient contacting portion; (d) the predetermined shape is a non-planar shape; (e) the gas delivery tube includes a trapezoidal cross-section; (f) the patient contacting portion includes a non-planar shape; (g) the patient contacting portion has a flatter shape than the non-patient contacting portion; (h) the patient contacting portion is under tension across the width of the patient contacting portion; (i) the patient contacting portion is biased along the non-patient contacting portion by the patient contacting portion The length of the patient contacting portion pulls the non-patient contacting portion at the edge; (j) the non-patient contacting portion and the patient contacting portion are joined at a pair of joints; (k) the patient contacting portion and the non-patient contacting portion each include a front edge and a rear edge, the front edge is joined along the length of the gas delivery tube, and the rear edge is joined along the length of the gas delivery tube; (l) the front edges are joined to form a front seam of the gas delivery tube, and the rear edges are joined to form a rear seam of the gas delivery tube; (m) the front seam and / or the rear seam are thermoformed; (n) the patient contacting portion and the non-patient contacting portion are thermoformed.

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

[0124] In further examples: (a) the patient contacting portion can be harder than the non-patient contacting portion; (b) the non-patient contacting portion can be more stretchable than the patient contacting portion; (c) the patient contacting portion can include a greater thickness than the non-patient contacting portion; (d) the patient contacting portion can include an inward-facing surface, the inward-facing surface configured to rest against the patient's head, the inward-facing surface having a higher coefficient of friction relative to the patient's skin than the outward-facing surface of the non-patient contacting portion.

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

[0126] According to one aspect of the present technology, a positioning and stabilizing structure is provided that provides a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head. The seal-forming structure is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, for use in sealingly delivering a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilizing structure may include at least one gas delivery tube to receive a flow of air from a connection port at the top of the patient's head and deliver the flow of air to the entrance of the patient's airway via the seal-forming structure. The gas delivery tube is constructed and arranged to contact, during use, a region of the patient's head at least above a supra-auricular base of the patient's head. The gas delivery tube includes a tube wall defining a hollow interior through which air can flow to the seal-forming structure. The tube wall may include 1) a patient-contacting portion including a first outer layer comprising a fabric or foam material configured to rest against the patient's head during use; and 2) a non-patient-contacting portion including a second outer layer comprising a fabric or foam material on a side of the gas delivery tube opposite the first outer layer.

[0127] In examples: (a) the patient contacting portion comprises a greater stiffness than the non-patient contacting portion; (b) the patient contacting portion comprises a greater thickness than the non-patient contacting portion; (c) the patient contacting portion is thermoformed by a first thermoforming process and the non-patient contacting portion is thermoformed by a second thermoforming process, wherein the first thermoforming process provides the patient contacting portion with a greater stiffness than the second thermoforming process provides the non-patient contacting portion with stiffness; (d) both the patient contacting portion and the non-patient contacting portion are formed of layers, the patient contacting portion comprising a greater number of layers than the non-patient contacting portion; (e) the patient contacting portion comprises a rigidifying layer; and (f) the patient contacting portion comprises a rigidifying member.

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

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

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

[0131] According to another aspect of the present technology, a positioning and stabilizing structure is provided that provides a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head. The seal-forming structure is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, for use in sealingly delivering a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle. The positioning and stabilizing structure may include at least one gas delivery tube to receive the flow of air from the top of the patient's head and deliver the flow of air to the entrance of the patient's airway via the seal-forming structure. The gas delivery tube is constructed and arranged to contact, during use, an area of ​​the patient's head at least above a supra-auricular base of the patient's head. The gas delivery tube includes a tube wall defining a hollow interior through which air can flow to the seal-forming structure. The tube wall may include 1) a patient contacting portion configured to rest against the patient's head during use; and 2) a non-patient contacting portion on a side of the gas delivery tube opposite the patient contacting portion.

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

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

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

[0135] According to one aspect of the present technology, a positioning and stabilizing structure is provided that provides a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure being constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, for sealingly delivering a flow of air at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle, during use. The positioning and stabilizing structure may include at least one gas delivery tube to receive the flow of air from a connection port on the top of the patient's head and deliver the flow of air to the entrance to the patient's airway via the seal-forming structure, the gas delivery tube being constructed and arranged to contact, during use, an area of ​​the patient's head at least above a supra-auricular base of the patient's head, the gas delivery tube including a tube wall defining a hollow interior through which air can flow to the seal-forming structure. The tube wall may include 1) a patient contacting portion, the patient contacting portion including a first outer layer, the first outer layer comprising a fabric or foam material configured to rest against the patient's head during use; and 2) a non-patient contacting portion, the non-patient contacting portion including a second outer layer, the second outer layer comprising a fabric or foam material on a side of the gas delivery tube opposite the first outer layer, wherein at least one seam is formed by joining an edge of the non-patient contacting portion to a corresponding edge of the patient contacting portion.

[0136] In examples: (a) at least one seam provides rigidity to at least one gas delivery tube; (b) at least one seam is formed by a thermoforming process; (c) at least one seam includes rigidity provided by compression of edges forming the seam during the thermoforming process; and (d) at least one seam is welded.

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

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

[0139] In examples: (a) the front seam comprises greater stiffness than the back seam; (b) the greater stiffness of the front seam is provided by greater compression of the edge forming the front seam during the thermoforming process compared to the edge forming the back seam; (c) the thickness of the front seam is greater than the thickness of the back seam; (d) the width of the front seam is greater than the width of the back seam.

[0140] In an example: (a) at least one seam includes a rear seam, wherein the patient contacting portion and the non-patient contacting portion of the gas delivery tube each include a rear edge, and the rear edges of the patient contacting portion and the non-patient contacting portion are joined to form the rear seam; (b) the rear seam includes a widened portion, and the widened portion is configured to be connected to a strap of the positioning and stabilizing structure; (c) the rear seam includes an eyelet, and the eyelet is configured to be connected to the strap; (d) the rear seam includes a hole configured for receiving the strap, and the hole allows the strap to pass therethrough and loop back and secure to itself; (e) the eyelet in the rear seam includes a slit; (f) the positioning and stabilizing structure includes an eyelet reinforcement portion configured to reinforce the eyelet; (g) the eyelet reinforcement portion is disposed within the hole in the rear seam and is configured to reinforce the shape of the hole; (h) the eyelet reinforcement portion is substantially rigid.

[0141] According to one aspect of the present technology, a positioning and stabilizing structure is provided to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head for positive airway pressure therapy for sleep-disordered breathing. The positioning and stabilizing structure may include at least one gas delivery tube to deliver a flow of air to an entrance to the patient's airway via the seal-forming structure, each gas delivery tube being constructed and arranged to contact a region of the patient's head at least above a supra-auricular base point of the patient's head during use, each gas delivery tube including a tube wall defining a hollow interior through which air can flow to the seal-forming structure.

[0142] In an example: (a) each gas delivery tube may include an upper tube portion, the upper tube portion being configured to extend, in use, from a position on the top of the patient's head to a position along the side of the patient's head or face, the upper tube portion comprising a fabric material and / or a foam material; (b) each gas delivery tube may include a lower tube portion, the lower tube portion being configured to extend from a position along the side of the patient's head or face to a position adjacent to the entrance of the patient's airway, the lower tube portion comprising a fabric material and / or a foam material; (c) one of the lower tube portion and the upper tube portion has greater stiffness than the other of the lower tube portion and the upper tube portion.

[0143] In a further example: (a) the upper tube portion includes a first end and a second end, the first end being configured to rest against an upward-facing surface of the patient's head during use, and the second end being configured to rest against an outward-facing surface of the patient's head during use; (b) the lower tube portion includes a first end and a second end, the first end being configured to rest against an outward-facing surface of the patient's head during use, and the second end being configured to form a structural connection with the seal; (c) the lower tube portion is configured to form a structural fluid connection between the upper tube portion and the seal during use; (d) the upper tube portion is adapted to receive an air flow from a source via a crown connector, the crown connector being arranged to be positioned on top of the patient's head during use; (e) the positioning and stabilizing structure further includes a crown connector, the at least one gas delivery tube including a pair of gas delivery tubes, the crown connector being configured to be positioned on top of the patient's head during use to fluidly connect between the pair of gas delivery tubes, the crown connector including a hollow interior and a fluid connection opening, the fluid connection opening being configured to receive the air flow into the hollow interior.

[0144] In further examples: (a) one of the lower tube portion or the upper tube portion is configured with a first material layer and a second material layer, the first material layer being more rigid than the second material layer; (b) the lower tube portion and / or the upper tube portion is configured with a rigidifying element to provide rigidity to the lower tube portion and / or the upper tube portion; (c) the lower tube portion and / or the upper tube portion is configured with a seam; (d) the lower tube portion is formed as a first tube and the upper tube portion is formed as a second tube, the first tube being joined to the second tube; (e) the first tube portion is connected to the upper tube portion by thermoforming, ultrasonic welding, sewing, gluing, or a removable connector. The gas delivery tube is coupled to a second tube; (f) each gas delivery tube has a patient contact portion configured to contact a patient during use and a non-patient contact portion positioned away from the patient during use, the patient contact portion and / or the non-patient contact portion comprising a plurality of layers; (g) the patient contact portion comprises a first outer layer comprising a fabric material or a foam material; (h) the non-patient contact portion comprises a second outer layer comprising a fabric material or a foam material; (i) the patient contact portion and / or the non-patient contact portion comprises an intermediate layer comprising a foam material or a spacer fabric.

[0145] In further examples: (a) the lower tube portion has a greater stiffness than the upper tube portion; (b) the wall thickness of the lower tube portion is greater than the wall thickness of the upper tube portion to provide greater stiffness to the lower tube portion; (c) the lower tube portion has at least one additional layer that is not provided to the upper tube portion to provide greater stiffness to the lower tube portion; (d) the lower tube portion includes a material that is less elongated in length than the material of the upper tube portion to provide greater stiffness to the lower tube portion; (e) the lower tube portion includes a plurality of layers, and a rigidifying element is provided for one of the plurality of layers to provide greater stiffness to the lower tube portion; (f) the lower tube portion includes a greater number of layers than the upper tube portion. layer, thereby providing greater rigidity to the lower tube portion; (g) the upper tube portion and the lower tube portion each include a fabric layer, the fabric layer in the lower tube portion has a weaving structure different from the weaving structure of the fabric layer in the upper tube portion, and the weaving structure of the lower tube portion provides greater rigidity to the lower tube portion than the upper tube portion; (h) the lower tube portion has a greater resistance to bending in a downward direction than to bending in a middle direction during use; (i) the upper tube portion has a greater resistance to bending in a front direction and / or a rearward direction than to bending in a downward direction during use; and (j) the upper tube portion has greater rigidity than the lower tube portion.

[0146] According to one aspect of the present technology, a positioning and stabilizing structure is provided to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head for positive airway pressure therapy for sleep-disordered breathing. The positioning and stabilizing structure may include at least one gas delivery tube to deliver a flow of air to an entrance to the patient's airway via the seal-forming structure, each gas delivery tube being constructed and arranged to contact a region of the patient's head at least above a supra-auricular base point of the patient's head during use, each gas delivery tube including a tube wall defining a hollow interior through which air can flow to the seal-forming structure.

[0147] In an example: (a) each gas delivery tube may include a first section of elongated material having opposing first and second edges along its length; (b) each gas delivery tube may include a second section of elongated material having opposing first and second edges along its length; (c) each gas delivery tube may include a third section of elongated material having opposing first and second edges along its length; (d) the first section of elongated material is joined to the second section of elongated material along the first edge of the first section of elongated material and the second edge of the second section of elongated material, and the second section of elongated material is joined to the third section of elongated material along the first edge of the second section of elongated material and the second edge of the third section of elongated material to form the tube wall of the gas delivery tube; (e) the outer layer of the gas delivery tube includes a fabric material and / or a foam material.

[0148] In a further example: (a) each gas delivery tube is configured to extend, in use, from a position on the top of the patient's head along the side of the patient's face to a position adjacent to the entrance of the patient's airway; (b) the first section of slender material, the second section of slender material and the third section of slender material each include multiple layers; (c) the first section of slender material has at least one additional layer, which is not provided to the second section of slender material and / or the third section of slender material, to provide greater rigidity to the first section of slender material; (d) the wall thickness of the first section of slender material is greater than the wall thickness of the second section of slender material and / or the third section of slender material, to provide greater rigidity to the first section of slender material; (e) the first section of slender material has at least one additional layer, which is not provided to the second section of slender material and / or the third section of slender material (f) the first segment of elongated material comprises a greater number of layers than the second segment of elongated material and / or the third segment of elongated material, thereby providing greater stiffness to the first segment of elongated material; (g) the first segment of elongated material comprises a greater number of layers than the second segment of elongated material and / or the third segment of elongated material, thereby providing greater stiffness to the first segment of elongated material; (h) each gas delivery tube configuration comprises a patient contact portion configured to contact the patient's body and a non-patient contact portion configured to be oriented away from the patient's body during use, the patient contact portion comprising the first segment of elongated material, and the non-patient contact portion comprising the second segment of elongated material and the third segment of elongated material.

[0149] In a further example: (a) each gas delivery tube further includes an interior covered by the outer layer, the interior including a foam material and / or a spacer fabric; (b) the outer layer of the gas delivery tube includes a sleeve, the sleeve being configured to enclose the first section of slender material, the second section of slender material, and the third section of slender material; (c) the outer layer of the gas delivery tube includes three sections of slender material corresponding to the first section of slender material, the second section of slender material, and the third section of slender material, respectively.

[0150] In further examples: (a) the positioning and stabilizing structure further includes 1) a first seam along a first edge of the first length of elongated material and a second edge of the second length of elongated material to connect the first length of elongated material and the second length of elongated material; and 2) a second seam along a first edge of the second length of elongated material and a second edge of the third length of elongated material to connect the second length of elongated material and the third length of elongated material; (b) the first length of elongated material has a concave shape to position the first seam away from the patient's face during use; (c) the first seam and / or the second seam imparts a seal to the gas delivery tube. stiffness; (d) the first seam imparts greater stiffness to the gas delivery tube than the second seam; (e) the positioning and stabilizing structure further comprises a stiffening element embedded in or laminated on the first seam and / or the second seam to provide stiffness to the gas delivery tube; (f) the stiffening element comprises a metal or plastic material; (g) the at least one gas delivery tube comprises a pair of gas delivery tubes; (h) the positioning and stabilizing structure further comprises a crown connector configured to be positioned on the top of the patient's head in use to provide a fluid connection between the pair of gas delivery tubes.

[0151] According to one aspect of the present technology, a positioning and stabilizing structure is provided to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head for positive airway pressure therapy for sleep-disordered breathing. The positioning and stabilizing structure may include at least one gas delivery tube to deliver a flow of air to an entrance to the patient's airway via the seal-forming structure, each gas delivery tube being constructed and arranged to contact a region of the patient's head at least above a supra-auricular base point of the patient's head during use, each gas delivery tube including a tube wall defining a hollow interior through which air can flow to the seal-forming structure.

[0152] In an example: (a) each gas delivery tube may include: 1) a patient contacting portion configured to contact a patient's body; 2) a non-patient contacting portion configured to be oriented away from the patient's body during use; and 3) at least one seam to connect the patient contacting portion and the non-patient contacting portion; (b) at least one seam includes a rigidifying element embedded in or laminated on the seam to provide rigidity to the gas delivery tube.

[0153] In a further example: (a) the at least one seam includes a first seam and a second seam; (b) the first seam provides greater or lesser stiffness to the gas delivery tube than the second seam; (c) in use, each gas delivery tube is configured to extend along a side of the patient's face, and the first seam is configured to be positioned anteriorly relative to the patient's face, and the second seam is configured to be positioned posteriorly relative to the patient's face; (d) the rigidizing element includes a metal or plastic material; (e) the rigidizing element includes a yarn having a lower melting temperature than surrounding yarns; (f) the patient contacting portion includes a first length of elongated material, and the non-patient contact portion includes at least a second section of slender material; (g) the non-patient contact portion includes a third section of slender material; (h) the patient contact portion and the non-patient contact portion each include multiple layers; (i) each gas delivery tube is configured to extend from a position on the top of the patient's head along the side of the patient's face to a position adjacent to the entrance of the patient's airway in use; (j) each gas delivery tube includes a fabric material and / or a foam material; (k) at least one gas delivery tube includes a pair of gas delivery tubes; (l) the at least one seam is thermoformed or ultrasonically welded to join the patient contact portion and the non-patient contact portion.

[0154] According to one aspect of the present technology, a positioning and stabilizing structure is provided to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head for positive airway pressure therapy of sleep-disordered breathing. The positioning and stabilizing structure may include a pair of gas delivery tubes for delivering a flow of air to an entrance to the patient's airway via the seal-forming structure, each gas delivery tube being constructed and arranged to extend, in use, from a position on top of the patient's head to a position adjacent to the entrance to the patient's airway, each gas delivery tube including a tube wall defining a hollow interior of the gas delivery tube through which air can flow.

[0155] In an example: (a) the positioning and stabilizing structure may further include a crown connector comprising a hollow interior and a pair of crown connector tube portions, the hollow interior forming a conduit structure, the conduit structure including a fluid connection opening configured to receive an air flow entering the hollow interior, the pair of crown connector tube portions being used to deliver the air flow to the pair of gas delivery tubes, the crown connector tube portions being capable of being removably connected to the pair of gas delivery tubes, the crown connector being configured to be positioned at a position on the top of the patient's head during use; (b) each crown connector tube portion includes a crown connector and each gas delivery tube includes a corresponding headband tube connector, the headband tube connector being configured to engage the corresponding crown connector to removably connect the crown connector and the gas delivery tube; (c) each crown connector is arranged along an inner surface of the corresponding crown connector tube portion; (d) the crown connector includes a flexible material; (e) each crown connector includes a material that is more rigid than the flexible material of the crown connector.

[0156] In further examples: (a) the crown connector comprises silicone; (b) each crown connector comprises polycarbonate, polypropylene, a semi-rigid or rigid plastic material and / or nylon; (c) each crown connector tube comprises a crown connector port through which air flow is delivered to a corresponding one of the gas delivery tubes; (d) each crown connector is a rigid female connector insert disposed adjacent a corresponding crown connector port; (e) each crown connector has a ring or loop shape corresponding to a cross-sectional shape of a corresponding crown connector tube; (f) each crown connector provides rigidity to a corresponding crown connector tube; (g) each (h) each crown connector tube portion is overmolded onto a corresponding crown connector; (i) each headband tube connector is configured to form a removable snap-fit ​​connection with a corresponding one of the headband tube connectors; (j) the crown connector includes a sealing flange arranged around the fluid connection opening; (k) the positioning and stabilizing structure may further include a rotating ring, which is configured to form a seal with the sealing flange, the rotating ring being removably connected to the rigid conduit and allowing the rigid conduit to rotate relative to the rotating ring when connected.

[0157] In a further example: (a) each gas delivery tube is constructed and arranged to extend between the eyes and ears of the patient along a corresponding side of the patient's face in use; (b) each gas delivery tube has a patient contacting portion configured to contact the patient in use and a non-patient contacting portion positioned away from the patient in use, and wherein the patient contacting portion and / or the non-patient contacting portion include multiple layers; (c) each gas delivery tube includes a fabric material and / or a foam material; (d) the patient contacting portion includes a first outer layer, the first outer layer includes a fabric material or a foam material; (e) the non-patient contacting portion includes a second outer layer, the second outer layer includes a fabric material or a foam material.

[0158] According to one aspect of the present technology, a positioning and stabilizing structure is provided to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head for positive airway pressure therapy of sleep-disordered breathing. The positioning and stabilizing structure may include a pair of gas delivery tubes for delivering a flow of air to an entrance to the patient's airway via the seal-forming structure, each gas delivery tube being constructed and arranged to extend, in use, from a position on top of the patient's head to a position adjacent to the entrance to the patient's airway, and each gas delivery tube may include a tube wall defining a hollow interior of the gas delivery tube, through which air can flow.

[0159] In an example: (a) the positioning and stabilizing structure may further include a crown connector comprising a hollow interior and a pair of crown connector tube portions, the hollow interior forming a conduit structure, the conduit structure including a fluid connection opening configured to receive an air flow entering the hollow interior, the pair of crown connector tube portions being used to deliver the air flow to the pair of gas delivery tubes, the crown connector tube portions being removably connectable to the pair of gas delivery tubes, the crown connector being configured to be positioned at a position on top of the patient's head in use; (b) the fluid connection opening is adapted to receive an air flow from a rigid conduit, the rigid conduit being adapted to be removably connected to the crown connector at the fluid connection opening, (c) the lower wall of the crown connector includes an anti-blocking piece arranged thereon at a central position below the fluid connection opening to prevent the rigid conduit from contacting the lower wall and thereby reducing or cutting off the air flow through the hollow interior; (d) the lower wall of the crown connector includes at least one slope along its inner surface, the slope sloping downwardly toward the anti-blocking piece.

[0160] In a further example: (a) the crown connector includes silicone; (b) the at least one slope includes a first slope and a second slope respectively disposed on opposite sides of the anti-blocking piece, the first slope and the second slope each being inclined downwardly toward the anti-blocking piece; (c) the lower wall of the crown connector includes reinforcements along opposite front and rear sides of the crown connector, and the front and rear ends of the anti-blocking piece are disposed in the reinforcements to provide stability to the anti-blocking piece; (d) the reinforcement includes a portion of the lower wall having an increased thickness relative to the at least one slope; (e) each crown connector tube portion includes a crown connector port, and the air flow is delivered to a corresponding one of the gas delivery tubes through the crown connector port; (f) each crown connector tube portion includes a crown connector, and each gas delivery tube includes corresponding tube connectors, the corresponding tube connectors being configured to engage corresponding crown connectors to removably connect the crown connector and the gas delivery tube; (g) each crown connector being a rigid female connector insert disposed adjacent a corresponding crown connector port; (h) the crown connector comprising a sealing flange disposed about the fluid connection opening; (i) the positioning and stabilizing structure may further comprise a rotating ring configured to form a seal with the sealing flange, the rotating ring being removably connected to the rigid conduit and allowing the rigid conduit to rotate relative to the rotating ring when connected; (j) the crown connector comprising a lip seal extending radially inwardly from the fluid connection opening at a position within the hollow interior of the crown connector and being adapted to form a seal with the lower end of the rigid conduit.

[0161] In a further example: (a) each gas delivery tube is constructed and arranged to extend between the eyes and ears of the patient along a corresponding side of the patient's face in use; (b) each gas delivery tube has a patient contacting portion configured to contact the patient in use and a non-patient contacting portion positioned away from the patient in use, and wherein the patient contacting portion and / or the non-patient contacting portion include multiple layers; (c) each gas delivery tube includes a fabric material and / or a foam material; (d) the patient contacting portion includes a first outer layer, the first outer layer includes a fabric material or a foam material; (e) the non-patient contacting portion includes a second outer layer, the second outer layer includes a fabric material or a foam material.

[0162] According to one aspect of the present technology, a patient interface is provided. The patient interface may include 1) a seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airway to seal and deliver an air flow at a therapeutic pressure of at least 6 cm H2O above ambient air pressure throughout the patient's breathing cycle; and 2) a positioning and stabilizing structure according to any of the above aspects.

[0163] According to one aspect of the present technology, a patient interface is provided. A patient interface comprising: 1) a plenum chamber pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing; 2) a seal-forming structure constructed and arranged to seal with a patient's facial area surrounding an entrance to the patient's airway, the seal-forming structure having apertures therein such that the flow of air at the therapeutic pressure is delivered to at least the patient's nostrils, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle; 3) a positioning and stabilizing structure according to any of the above aspects; and 4) a ventilation structure allowing gas exhaled by the patient to flow continuously from the interior of the plenum chamber to the surrounding environment, the ventilation structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use; wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth in the absence of pressurized air flow through the plenum chamber inlet port, or the patient interface is configured such that the patient's mouth is uncovered.

[0164] Another aspect of some forms of the present technology is a system for treating a respiratory disorder comprising a patient interface, an air circuit, and a positive pressure air source according to any one or more of the other aspects of the present technology.

[0165] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that is complementary to the peripheral shape of the intended wearer.

[0166] One aspect of one form of the present technology is a method of manufacturing a component of a medical device.

[0167] Another aspect of some forms of the present technology is a patient interface comprising a seal-forming structure configured not to cover a patient's mouth during use.

[0168] Another aspect of some forms of the present technology is a patient interface comprising a seal-forming structure configured such that no portion of the seal-forming structure enters the mouth during use.

[0169] Another aspect of some forms of the present technology is a patient interface comprising a seal-forming structure configured such that the seal-forming structure does not extend inside an airway of a patient.

[0170] Another aspect of some forms of the present technology is a patient interface comprising a seal-forming structure configured such that, in use, the seal-forming structure does not extend beneath a metallic raised area.

[0171] Another aspect of some forms of the present technology is a patient interface constructed and arranged so as not to cover the patient's eyes during use.

[0172] Another aspect of some forms of the present technology is a patient interface constructed and arranged to allow a patient to breathe ambient air in the event of a power failure.

[0173] Another aspect of certain forms of the present technology is a patient interface comprising a seal-forming structure configured to form a seal on an underside of a patient's nose without contacting a nasal bridge area of ​​the patient's nose.

[0174] Another aspect of some forms of the present technology is a patient interface comprising a vent and a plenum chamber, wherein the patient interface is constructed and arranged such that gas from the interior of the plenum chamber can pass to the surrounding environment via the vent.

[0175] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged such that, in use of the patient interface, a patient can comfortably lie on their side or in a side-lying sleeping position.

[0176] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged such that, in use of the patient interface, a patient can comfortably lie in a supine sleeping position.

[0177] Another aspect of certain forms of the present technology is a patient interface that is constructed and arranged such that, in use of the patient interface, a patient can be comfortably positioned in a prone sleeping position.

[0178] One aspect of some forms of the present technology is a medical device that is easy to use, for example, by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using medical devices of this type.

[0179] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., within the person's home).

[0180] One aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example, in soapy water, without the need for specialized cleaning equipment.

[0181] Of course, a part of these aspects may form a sub-aspect of the present technology. In addition, each aspect in the sub-aspect and / or aspect may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

[0182] Other features of the technology will become apparent upon consideration of the information contained in the following detailed description, abstract, drawings, and claims. 4 Description of the accompanying drawings

[0183] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals indicate similar elements, including:

[0184] 4.1 Treatment System

[0185] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows and receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient sleeps in a supine position.

[0186] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0187] Figure 1C A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask, receiving a supply of air under positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered along an air circuit 4170 to the patient 1000. The patient sleeps in a side-lying position.

[0188] 4.2 Respiratory system and facial anatomy

[0189] Figure 2A Shown is a schematic diagram of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0190] Figure 2B A view of the human upper airway is shown, including the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, superior lip, inferior lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0191] Figure 2C A front view of the face with several surface anatomical features labeled, including the superior lip, upper vermilion, lower vermilion, inferior lip, mouth width, medial canthus, nasal ala, nasolabial fold, and corner of the mouth. The directions superior, inferior, radially inward, and radially outward are also indicated.

[0192] Figure 2DIt is a side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge, nasal prominence, subseptal point, supra-lip, sublip, supra-chin, nasal ridge, apex of the nose, and supra-auricular and subauricular points. The superior-inferior and anterior-posterior directions are also indicated.

[0193] Figure 2E This is another lateral view of the head. The approximate locations of the Frankfort horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0194] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, upper vermillion, nostrils, inferior point of the nasal septum, columella, pronasal point, long axis of the nostrils, and the midsagittal plane.

[0195] Figure 2G A side view of the nasal surface features is shown.

[0196] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0197] Figure 2I The medial anatomy of the nose is shown approximately a few millimeters from the mid-sagittal plane, showing, among other things, the septal cartilage and the medial crus of the greater alar cartilage.

[0198] Figure 2J A frontal view of the skull is shown, including the frontal, nasal, and zygomatic bones. The nasal turbinates, as well as the maxilla and mandible are also indicated.

[0199] Figure 2K A side view of the skull is shown, with the outline of the head surface and several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital. The mental protuberance is also indicated. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0200] Figure 2L An anterolateral view of the nose is shown.

[0201] 4.3 Patient Interface

[0202] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0203] Figure 3B A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and when compared to Figure 3C The curvature magnitude shown is relatively large in comparison.

[0204] Figure 3C A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and when compared to Figure 3B The curvature magnitude shown is of relatively small magnitude in comparison.

[0205] Figure 3D A schematic diagram of a cross section through a structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0206] Figure 3E A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and when compared to Figure 3F The curvature magnitude shown is of relatively small magnitude in comparison.

[0207] Figure 3F A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and when compared to Figure 3E The curvature magnitude shown is relatively large in comparison.

[0208] Figure 3G A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are shown. The dome and saddle areas are shown.

[0209] Figure 3H A cushion for a face mask is shown. The outer surface of the cushion is indicated. The edge of the surface is shown. The path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. The two saddle areas and the dome area are indicated.

[0210] Figure 3I A surface having a structure with one-dimensional holes on the surface is shown. The plane curves shown form the boundaries of the one-dimensional holes.

[0211] Figure 3J Shown through Figure 3I The surface shown is in the cross section of the structure. Figure 3I A two-dimensional hole is defined in the structure.

[0212] Figure 3K Shown Figure 3I A perspective view of the structure of , including two-dimensional holes and one-dimensional holes. Also shown is the Figure 3I The surface defining the two-dimensional pores in the structure.

[0213] Figure 3L A mask is shown with an inflatable bladder as a cushion.

[0214] Figure 3MShown through Figure 3L FIG. 1 is a cross-section of a mask of FIG. 1 and shows the inner surface of the airbag. The inner surface defines a two-dimensional hole in the mask.

[0215] Figure 3N Shown by Figure 3L Another cross section of a mask. The inner surface is also indicated.

[0216] Figure 3O The left-hand rule is shown.

[0217] Figure 3P The right-hand rule is shown.

[0218] Figure 3Q The left ear is shown, including the left ear helix.

[0219] Figure 3R The right ear is shown, including the right ear helix.

[0220] Figure 3S A right-hand helix is ​​shown.

[0221] Figure 3T A view of a mask is shown including symbols for the twisting of the spatial curve defined by the edge of the sealing membrane in different regions of the mask.

[0222] Figure 3U A view of the plenum chamber 3200 is shown, illustrating the sagittal plane and the medial contact plane.

[0223] Figure 3V Shown Figure 3U A view of the rear portion of the plenum chamber. The view is oriented perpendicular to the median contact plane. Figure 3V The sagittal plane in the middle bisects the plenum into left-hand and right-hand sides.

[0224] Figure 3W Shown through Figure 3V The cross section of the gas-filled chamber is Figure 3V 32. The image is taken in the sagittal plane shown. A "mid-contact" plane is shown. The mid-contact plane is perpendicular to the sagittal plane. The orientation of the mid-contact plane corresponds to the orientation of the chord 3210, which lies in the sagittal plane and contacts the plenum cushion at two points exactly in the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the cushion in the region, the mid-contact plane can be tangent at both the upper and lower points.

[0225] Figure 3X Shown Figure 3UThe position of the inflatable chamber 3200 on the face when in use. When the inflatable chamber is in the use position, the sagittal plane of the inflatable chamber 3200 substantially coincides with the median sagittal plane of the face. When the inflatable chamber is in the use position, the median contact plane substantially corresponds to the "plane of the face". Figure 3X In FIG, the inflation chamber 3200 is the inflation chamber of the nasal mask, and the upper point 3220 is located approximately on the bridge of the nose, while the lower point 3230 is located on the upper lip.

[0226] Figure 4A An isometric view of a patient interface according to an example of the present technology is shown.

[0227] Figure 4B An isometric view of a patient interface worn on a patient is shown.

[0228] Figure 4C A side view of the patient interface as worn on a patient is shown.

[0229] Figure 4D A top view of the patient interface as worn on a patient is shown.

[0230] Figure 4E An isometric view of the tubes of a patient interface is shown in a planar configuration when placed on a flat surface.

[0231] Figure 4F A proportional cross section of a portion of the tube is shown.

[0232] Figure 4F-1 An enlarged portion of the layers of the tube is shown.

[0233] Figure 4F-2 An enlarged portion of the layers of the tube is shown.

[0234] Figure 4G Shown as Figure 4C A cross-section of a portion of the patient interface is shown.

[0235] Figure 4H Shown as Figure 4C A cross-section of a portion of a patient interface is shown.

[0236] Figure 4I Possible cross-sectional shapes of the tube of the patient interface are shown.

[0237] Figure 4J Another possible cross-sectional shape of the tube of the patient interface is shown.

[0238] Figure 4K Another possible cross-sectional shape of the tube of the patient interface is shown.

[0239] Figure 4L-1 An isometric view of the tube is shown in a predetermined three-dimensional configuration.

[0240] Figure 4L-2 is a side view of a portion of a tube.

[0241] Figure 4L-3 This is a front view of a portion of a tube.

[0242] Figure 4L-4 is a top view of a part of a tube.

[0243] Figure 4M An isometric cutaway view depicting the connection ports within the tube.

[0244] Figure 4N Depicts an isometric view of isolated connection ports.

[0245] Figure 4O An isometric view of an alternative connecting portion is depicted.

[0246] Figure 4P The connection between the mask and the tube is depicted.

[0247] Figure 4Q Depicted are alternative forms of connectors for attaching the mask to the tube.

[0248] Figure 4R An isometric view of a patient interface according to another example of the present technology being worn by a patient is shown.

[0249] Figure 4S is a perspective view of a patient interface according to another example of the disclosed technology.

[0250] Figure 4T is a front perspective view of an upper connector of a positioning and stabilizing structure according to an example of the disclosed technology.

[0251] Figure 4U is a side perspective view of a lower connector of a positioning and stabilizing structure according to an example of the disclosed technology.

[0252] Figure 4V yes Figure 4S Illustration of a cross section of a positioning and stabilizing structure.

[0253] Figure 4W is a cross-sectional illustration of an outer layer of a positioning and stabilizing structure according to another example of the disclosed technology.

[0254] Figure 4X is a perspective view of a patient interface according to another example of the disclosed technology.

[0255] Figure 5A A view depicting the straps of a patient interface.

[0256] Figure 5BA side view of a portion of a strap is depicted.

[0257] Figure 5C A partially exploded view of a portion of strap 3420 is depicted.

[0258] Figure 5D and 5E A portion of a strap is depicted in an untensioned and tensioned state.

[0259] Figure 5F An alternative patient interface including an alternative head strap is depicted.

[0260] Figure 5G Depicts Figure 5F head strap separate top view.

[0261] Figure 5H Depicts an exploded isometric view of the head strap.

[0262] Figure 6A Depicted is an isometric top view of a seal-forming structure for use in a patient interface.

[0263] Figure 6B An isometric bottom view of the seal-forming structure of a patient interface is depicted.

[0264] Figure 6C An isometric view of the sealing layer depicting the seal-forming structure.

[0265] Figure 6D A cross-sectional isometric view of the sealing layer is depicted.

[0266] Figure 6D-1 An enlarged view of a portion of the sealing layer is depicted.

[0267] Figure 6E Depicted is a seal-forming structure attached to a frame.

[0268] Figure 7A Depicted is a mold for forming a sealing layer.

[0269] Figure 7B Depicted is a fabric sheet positioned to engage a mold.

[0270] Figure 7C A sheet of fabric is depicted adjacent to a mold and unrolled over the mold using rollers.

[0271] Figure 7D Depicted is a sheet of fabric pressed into a mold form.

[0272] Figure 7E Depicted is a film layer applied to a fabric sheet within a mold.

[0273] Figure 7FDepicted is subjecting the film layer to heating.

[0274] Figure 7G Removal of the solidified layer from the mold is depicted.

[0275] Figure 7H Cutting the seal forming layer into shape is depicted.

[0276] Figure 7I Depicted are pre-cut planar sheets prior to insertion into the mold.

[0277] Figure 7J The sheet is depicted after application within a mold.

[0278] Figure 8A Depicted is a sheet being placed on a mold to form a tube.

[0279] Figure 8B The sheet inside the mold is depicted.

[0280] Figure 8C Depicted is positioning of the film layer to interact with the sheet within the mold.

[0281] Figure 8D Heating the film layer is depicted so that the film layer solidifies into the shape of the mold.

[0282] Figure 8E Depicted is attaching two cured sheets together after curing.

[0283] Figure 8F A portion of a tube formed from two sheets is depicted.

[0284] Figure 8G Depicted is a sheet positioned over a mold.

[0285] Figure 8H Depicted is spraying a film layer onto the sheet while the sheet is in the mold.

[0286] Figure 8I Depicted are the sheet and film layers within the mold.

[0287] Figure 8J Removal of the solidified layer from the mold is depicted.

[0288] Figure 8K A tube formed from two solidified layers is depicted.

[0289] Figure 8L and 8M Another method for forming a tube for use in a patient interface is depicted.

[0290] Figure 9A and 9B Methods for forming tubes having alternative forms are depicted.

[0291] Figure 9C An alternative form of tube 3450 is depicted.

[0292] Figure 9D and 9E Depicts Figure 9C Cross-sections of tube 3450 in inflated and uninflated states.

[0293] Figure 10 Shown is a perspective view of a patient interface 9000 according to an example of the present technology.

[0294] Figure 11 Shown is a perspective view of a patient interface 10000 according to another example of the present technology.

[0295] Figure 12A and 12B is a detailed view of a headband tube connector according to an example of the present technology.

[0296] Figure 13 A perspective view of a gas delivery tube 9350 of a patient interface 9000 according to another example of the present technology is shown.

[0297] Figure 14 Shown Figure 11 A cross-sectional view of the gas delivery tube 9350.

[0298] Figure 15 is a perspective view showing a cross-section of a gas delivery tube 9350 according to another example of the present technology.

[0299] Figure 16 A diagram of a cross-section of a gas delivery tube 9350 is shown according to another example of the present technology.

[0300] Figure 17 A diagram of a cross-section of a non-patient contacting portion 9349 of a gas delivery tube is shown according to another example of the present technology.

[0301] Figure 18 Shown is a side view of a patient interface 9000 according to another example of the present technology.

[0302] Figure 19 Shown is a perspective view of a patient interface 9000 according to another example of the present technology.

[0303] Figure 20 Shown is a perspective view of a patient interface 9000 according to another example of the present technology.

[0304] Figure 21 Shown Figure 20 Left side view of Patient Interface 9000.

[0305] Figure 22 Shown Figure 20 Right side view of Patient Interface 9000.

[0306] Figure 23 Shown Figure 20 Front view of the patient interface 9000.

[0307] Figure 24 Shown Figure 20 A front view of the crown connector 9360 and elbow 9610 of the patient interface 9000 is shown.

[0308] Figure 25 Shown Figure 20 A perspective view of the crown connector 9360 of the patient interface 9000.

[0309] Figure 26 Shown Figure 20 9000 of the patient interface 9000.

[0310] Figure 27 The upper tube portion 9304 of the headband tube 9350 is shown along Figure 26 A cross-sectional view along line 27-27 in FIG.

[0311] Figure 28 The headband tube 9350 and the lower tube portion 9363 are shown along Figure 26 A cross-sectional view along line 28-28 in FIG.

[0312] Figure 29 Shown Figure 20 A cross section of the upper tube portion 9304 of the headband tube 9350 of the patient interface 9000 with some force marked.

[0313] Figure 30 Shown Figure 20 The tabs 3320 of the headgear tube 3350 of the patient interface 3000 are shown.

[0314] Figure 31 is a schematic diagram of a headband tube according to an example of the present technology.

[0315] Figure 32 is a schematic diagram of a headband tube according to another example of the present technology.

[0316] Figure 33 is a perspective view illustrating a cross-section of a gas delivery tube according to an example of the present technology.

[0317] Figure 33-1 It shows Figure 33 A magnified detail of a cross section of a gas delivery pipe's seam.

[0318] Figure 34is a perspective view illustrating a cross section of a headband tube including a tab portion according to an example of the present technology.

[0319] Figure 35 is a cross-sectional view of a crown connector connected to an elbow according to an example of the present technology.

[0320] Figure 36 Shown is a front view of a patient interface according to an example of the present technology.

[0321] Figure 37-1 and 37-2 Interchangeable crown connectors, each having a different length, are shown in accordance with an example of the present technology.

[0322] Figure 38 is a top view of a crown connector according to an example of the present technology.

[0323] Figure 39 yes Figure 38 A bottom perspective view of the crown connector.

[0324] Figure 40 It is along Figure 38 A cross-sectional view along line 40-40.

[0325] Figure 41-1 yes Figure 38 Top view of the crown connector.

[0326] Figure 41-2 is a top perspective view of a crown connector according to another example of the present technology.

[0327] Figure 42 It is along Figure 38 A cross-sectional view along line 42-42 in FIG.

[0328] 4.4RPT device

[0329] Figure 43A One form of RPT device according to the present technology is shown.

[0330] Figure 43B Schematic diagram of the pneumatic path of an RPT device according to one form of the present technology. Upstream and downstream directions are indicated with reference to the blower and the patient interface. The blower is defined as upstream of the patient interface and the patient interface is defined as downstream of the blower, regardless of the actual flow direction at any given moment. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0331] Figure 43C A schematic diagram illustrating the electrical components of an RPT device according to one form of the present technology is shown.

[0332] 4.5 Humidifier

[0333] Figure 44A Shown is an isometric view of a humidifier according to one form of the present technology.

[0334] Figure 44B An isometric view of a humidifier according to one form of the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130. 5. Specific Implementation Methods

[0335] Before describing the present technology in more detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terminology used in the present invention is only used to describe the specific examples discussed herein and is not intended to be limiting.

[0336] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, in any of the examples, any single feature or combination of features may constitute another example.

[0337] 5.1 Treatment

[0338] In one form, the present technology comprises a method for treating a breathing disorder comprising applying positive pressure to an airway entrance of a patient 1000 .

[0339] In some examples of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0340] In some examples of the present technology, mouth breathing is limited, restricted, or prevented.

[0341] 5.2 Treatment System

[0342] In one form, the present technology includes an apparatus or device for treating a respiratory disorder. The apparatus or device may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000 .

[0343] 5.3 Patient Interface

[0344] refer to Figure 3A, a non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to a form of air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway to facilitate the supply of positive pressure air to the airway.

[0345] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0346] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 6 cmH20 relative to ambient.

[0347] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 10 cmH20 relative to ambient.

[0348] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to supply air at a positive pressure of at least 20 cmH20 relative to ambient.

[0349] 5.3.1 Sealing structure

[0350] In one form of the present technology, the seal-forming structure 3100 provides a targeted seal-forming area and may additionally provide a cushioning function.

[0351] The target seal-forming area is the area on the seal-forming structure 3100 where sealing is likely to occur. The area where sealing actually occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given course of treatment, depending on a number of factors including, for example, where the patient interface is placed on the face, the tension in the positioning and stabilizing structures, and the shape of the patient's face.

[0352] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100.

[00106] A seal-forming structure 3100 in accordance with the present technology may be constructed of a soft, flexible, and resilient material such as silicone or other biocompatible material.

[0353] In one form, the seal-forming structure includes a sealing flange that utilizes a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to the positive system pressure acting on its bottom surface within the plenum 3200, thereby forming a tight sealing engagement with the face. The pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilizing structure.

[0354] In one form, the seal-forming structure may comprise a compression seal portion or a gasket seal portion which, in use, is constructed and arranged to be in a compressed state, for example as a result of elastic tension in the positioning and stabilising structure.

[0355] In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is maintained in tension, for example, by an adjacent area of ​​the sealing flange.

[0356] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0357] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having a tacky or adhesive surface.

[0358] The seal-forming structure 3100 can be non-invasive, i.e., does not extend inside the patient's airway. In some forms of the technology, no portion of the seal-forming structure 3100 enters the patient's mouth during use. In some forms of the technology, the seal-forming structure 3100 is configured so as not to cover the patient's mouth during use. In some forms of the technology, the seal-forming structure 3100 does not cover the patient's eyes during use.

[0359] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm, for example, about 0.25 mm to about 0.45 mm, which extends around the periphery of the inflatable chamber 3200. The support flange can be relatively thicker than the sealing flange and edge of the inflatable chamber 3200. And at least a portion of the route extending around the periphery. The support flange is or includes a spring-like element and acts to support the sealing flange to prevent it from bending during use. When in use, the sealing flange can easily respond to the system pressure acting on its bottom surface in the inflatable chamber 3200, so that it forms a tight sealing joint with the face.

[0360] In another form, the seal-forming portion of the non-invasive patient interface includes a pair of nasal puffs or nasal pillows, each of which is constructed and arranged to form a seal with a corresponding nostril of the patient's nose. Nasal pillows according to one aspect of the present technology include: a frustoconical body, at least a portion of which forms a seal on the bottom surface of the patient's nose; a stem; and a flexible region on the bottom surface of the frustoconical body and connecting the frustoconical body to the stem. In addition, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the bottom of the stem. The flexible regions can act together to facilitate a universal coupling structure that can adapt to relative movement of both displacement and angle between the frustoconical body and the structure to which the nasal pillows are connected. For example, the position of the frustoconical body can be moved axially toward the structure to which the stem is connected.

[0361] In one form, the seal-forming structure is configured to be used with the underside of the nose around the nostrils and optionally with the upper lip to form a seal. This type of seal-forming structure may be referred to as a "nasal cradle cushion" or "under-the-nose mask," such as the seal-forming structure 3100 of the non-invasive patient interface 3000. The shape of the seal-forming structure may be configured to match or closely follow the underside of the patient's nose, i.e., the contours and angles of the seal-forming structure may be substantially parallel to the nasolabial angle of the patient. In one form of the nasal cradle cushion, the seal-forming structure includes a septum member defining two orifices, each of which, in use, supplies air or breathable gas to a different one of the patient's nostrils. The septum member may be configured to contact or seal against the columella of the patient in use. In some forms of the technology, the seal-forming structure 3100 is configured to form a seal on the underside of the patient's nose without contacting the nasal bridge area of ​​the patient's nose. For example, in Figures 4A-4D , 10 and 11. In some examples, the patient interface can include a seal-forming structure 9100 in the form of a bracket cushion as described in PCT Publication WO 2018 / 176094 filed on March 29, 2018, the entire contents of which are incorporated herein by reference.

[0362] In one form, the non-invasive patient interface 3000 includes a seal-forming portion that, when in use, forms a seal over the upper lip region (i.e., upper lip), the nasal bridge region, and the cheek region of the patient's face. Figure 1B The patient interface 3000 is shown in FIG. The seal-forming portion delivers a supply of air or breathable gas to both nostrils of the patient 1000 through a single orifice. This type of seal-forming structure may be referred to as a "nasal cushion" or "nasal mask." In some examples of the present technology, positioning and stabilizing structures may be used to maintain the nasal cushion in a sealed position on the patient's face.

[0363] In one form, the non-invasive patient interface 3000 includes a seal-forming portion that, when in use, forms a seal over the chin, nasal bridge, and cheek regions of the patient's face. Figure 1C The patient interface 3000 is shown in FIG. The seal-forming portion delivers a supply of air or breathable gas to both nostrils and the mouth of the patient 1000 through a single orifice. This seal-forming structure may be referred to as a "full face mask." In some examples of the present technology, positioning and stabilizing structures may be used to maintain the full face cushion in a sealed position on the patient's face.

[0364] In another form, the patient interface 3000 includes a nasal seal-forming structure and an oral seal-forming structure in the form of a nasal cushion or nasal cradle cushion, the oral seal-forming structure being configured to form a seal around the patient's mouth (which may be referred to as a "mouth cushion" or "oral mask") in use. In such a mask, air or breathable gas is supplied to the patient's nostrils and the patient's mouth through separate orifices in use. Such a seal-forming structure 3100 may be referred to as an "oronasal cushion" or "ultra-compact full-face cushion". In one form, the nasal seal-forming structure and the oral seal-forming structure are integrally formed as a single component. In some examples, the patient interface may include a seal-forming structure in the form of a cradle cushion as described in PCT publication WO2019 / 183680 filed on March 28, 2019, the entire contents of which are incorporated herein by reference. In some examples of the present technology, positioning and stabilizing structures of the patient interface may be used to maintain the oronasal cushion in a sealed position on the patient's face.

[0365] In some prior art examples, the plenum 3200 has a perimeter shaped to complement the surface contours of an average person's face in the area where the seal is formed during use. During use, the boundary edge of the plenum is positioned in close proximity to adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure. The seal-forming structure may extend along the entire perimeter of the plenum during use. In some embodiments, the plenum and seal-forming structure are formed from a single homogeneous sheet of material.

[0366] In some forms of the present technology, the inflatable chamber does not cover the patient's eyes when in use. In other words, the eyes are outside the pressurized volume defined by the inflatable chamber. Such forms tend to be less obtrusive and / or more comfortable to the wearer, which can improve compliance with treatment.

[0367] In some forms of the present technology, the plenum chamber is constructed of a transparent material, such as clear polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface and help improve treatment compliance. The use of a transparent material can help the clinician observe how the patient interface is positioned and functioning.

[0368] In some forms of the present technology, the plenum chamber is constructed of a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with treatment.

[0369] In some forms of the technology, the seal-forming structure 3100 is configured such that, in use, the seal-forming structure does not extend beneath a metallic raised area of ​​a patient's head.

[0370] Unless expressly stated otherwise, embodiments of patient interfaces according to the present technology may include any of the above-described types of seal-forming structures.

[0371] 5.3.2 Sealing structure configuration

[0372] In some forms of the present technology, the seal-forming structure 3100 (also referred to as a cushioning structure, conformable structure, or interface structure) is constructed from a textile or fabric material. For example, the seal-forming structure 3100 can be woven, non-woven, knitted, or any other fiber web. Forming the seal-forming structure 3100 from a fabric material can increase the comfort and feel of the seal-forming structure relative to the patient's face. Increased comfort can increase the likelihood that the patient will continue to receive treatment using the device.

[0373] These sealing structures can be used to form a surface that presses against the patient's face to deliver air to the patient's nose and / or mouth. Some patients may experience a tactile sensation of the fabric material against their face, as opposed to silicone or other materials. The sealing structure can be formed using similar techniques and methods as described later in this detailed description with reference to the tube and air delivery system. For example, a cut and seal method and a lay-up method can be utilized.

[0374] In use, various components can be formed using this technology. In some embodiments, a mask component for a therapeutic device can be formed using a layer-by-layer manufacturing method. In one embodiment, a release agent is placed on a mold. Next, the layers for the mask are placed within the mold. The layers can be formed from a variety of materials. In some embodiments, the layers can be fabric-type materials. In other embodiments, the layers can be plastic, thermoplastic, rubber, silicone, or other bendable or flexible materials.

[0375] Reference Figure 6A and 6B, depicts a seal-forming structure in combination with a fabric. As shown, the seal-forming structure 3100 includes a sealing layer 3102 and a base 3104. The sealing layer 3102 can be fixed to the base 3104 so that the entire seal-forming structure 3100 can be attached to a receiving seat, which is attached to a supply conduit such as tube 3350. As shown, the sealing layer 3102 includes a predefined three-dimensional shape. This predefined three-dimensional shape is achieved without the help of air pressure or additional support structures other than the material of the sealing layer 3102 itself. The predefined three-dimensional shape is not defined by the thickness of the material forming the sealing layer 3102, but rather by the geometric position of the various parts of the sealing layer 3102. For example, the material from which the sealing layer 3102 is bent into various planes is configured to maintain its shape within these various planes.

[0376] like Figures 6A-6E As shown, the sealing layer 3102 can be formed to specifically interact and engage with the nasal region of the patient. When worn by the patient, the upper surface of the sealing layer 3102 can be configured to engage with specific portions of the patient's face. For example, portions adjacent to the first nostril opening 3108 and the second nostril opening 3110 can be configured to engage the patient's ala nostril, while the saddle region 3109 can be spaced apart from the patient's columella. Additionally, the nasolabial junction area 3106 can be shaped to engage with the patient's nasolabial groove. Furthermore, the seal-forming structure 3100 is configured such that the seal-forming structure 3100 does not obstruct the patient's mouth, enabling the patient to breathe through his or her mouth without pressurized air passing through the patient's mouth. Additionally, as Figures 6A-6E As shown, the sealing layer 3102 is formed in a manner that the sealing layer 3102 does not extend over the bridge of the nose. For example, when in use, the sealing layer 3102 does not cover at least the lateral cartilage portion, the nasal bone, and the septal cartilage (see FIG. Figure 2L ).

[0377] While air pressure is not required to support the shape of the sealing layer 3102 in some embodiments, portions of the sealing layer 3102 can be reinforced with air pressure to facilitate a good seal between the sealing layer 3102 and the patient's face. For example, in some embodiments, an accordion-shaped portion of the sealing layer 3102 can be formed adjacent to the base 3104. When pressure is applied, the accordion-shaped portion can expand, thereby providing additional sealing pressure between the sealing layer 3102 and the patient's face. Additionally, other portions of the sealing layer 3102 can be configured to expand to engage specific areas of the patient's face, such as the nasolabial folds.

[0378] The sealing layer 3102 can be deformable so that when pressed with a normal amount of force when used with the patient interface 3000, the sealing layer 3102 deforms. The sealing layer 3102 can conform to the shape of various parts of the patient's face to minimize air leakage. Once removed from the patient's face, the sealing layer 3102 can elastically return to its pre-deformed shape. In other words, once the force is released from the sealing layer 3102, the sealing layer 3102 returns to its unpressurized state, now having a three-dimensional shape.

[0379] The sealing layer 3102 can be formed from various layers such that the sealing layer 3102 is a laminated structure. Each layer can impart specific properties to the sealing layer 3102. In one form of the present technology, the sealing layer 3102 comprises a thermoplastic or thermosetting material. The material is capable of retaining a specific shape once cured into such a shape. For example, in one form, the sealing layer 3102 can comprise a thermosetting material, such as a foam material. The thermosetting material can conform to a mold and retain the shape of the mold, such as Figures 7A-7H shown.

[0380] The sealing layer 3102 can be configured to press against a specific area of ​​the nose or nasal region. For example, the nasolabial region 3106 can be configured to press against the nasolabial region of the patient. Additionally, other areas of the sealing layer 3102 can be specifically shaped to correspond to the patient's face. The sealing layer 3102 includes a first nostril opening 3108 and a second nostril opening 3110 configured to align with each of the patient's nostrils. Furthermore, the sealing layer 3102 includes a saddle region 3109 positioned between the first nostril opening 3108 and the second nostril opening 3110. The saddle region 3109 extends away from the user's columella during use, spacing the material of the sealing layer 3102 from the patient's nose for increased comfort.

[0381] The sealing layer 3102 can also be specifically shaped so that the surface that seals to the patient's face is spaced apart from the base 3104. By spacing the sealing layer 3102 apart from the base 3104, a buffer region can be formed between the softer surface of the sealing layer 3102 and the hard component of the base 3104. For example, Figure 6D As shown, the sealing layer 3102 has a height 3111 that separates the engagement surface of the sealing layer 3102 from other components of the patient interface 3000. In addition to having the height 3111, as shown throughout the figures, the sealing layer 3102 can have various regions having positive and negative curvatures, saddle-shaped regions, and domes, among other configurations. The specific shapes of the sealing layer can be formed to engage with the patient's airway. These specific shapes can be formed using molds having complex shapes or other techniques described in this detailed description.

[0382] In some embodiments, the first and second nostril openings 3108, 3110 may be elevated from the surrounding surface. That is, in some embodiments, the material surrounding the first and second nostril openings 3108, 3110 includes a flange 3107 that extends away from the surface of the sealing layer 3102, toward the user's nostrils. By elevating specific areas of the sealing layer 3102, a better or more secure fit can be achieved than with other techniques. For example, the first and second nostril openings 3108, 3110 may engage the nasal wall corresponding to the columella, ala, or other portion of the nostril. The flange 3107 may provide stability, limiting movement of the first and second nostril openings 3108, 3110 away from the nostril. This alignment provided by the first and second nostril openings 3108, 3110 may provide consistent oxygen administration to the patient. In some embodiments, the first and second nostril openings 3108, 3110 may have a substantially frusto-conical shape. In other embodiments, the shape of these openings may not taper like a frustoconical shape, but rather the flange 3107 may extend vertically. In other embodiments, the openings may be shaped to engage the inner surface of the nostril. In other embodiments, the material surrounding the first nostril opening 3108 and the second nostril opening 3110 may be evenly aligned with the material surrounding the sealing layer 3102.

[0383] Furthermore, the height or depth of the flange 3107 of the first nostril opening 3108 and the second nostril opening 3110 can be specifically formed. Some patients may prefer a configuration where the openings extend a greater distance into the patient's nostrils than other patients. Thus, the depth of the flange 3107 of the first nostril opening 3108 and the second nostril opening 3110 can be adjusted based on the preferences of the patient or a medical professional. The flange 3107 can be formed in a similar manner to the rest of the seal-forming structure 3102, where a foam or thermoset material can be used to maintain the shape of the flange even without air pressure or other rigid types of materials. The shape of the nostril can also depend on the shape of the mold used to form the sealing layer 102, such as Figures 7A-7H shown.

[0384] In some forms, the sealing layer 3102 can be specifically arranged to include more rigid and less rigid areas corresponding to specific areas of the patient. The sealing layer 3102 can include a more rigid or hard portion along the nasolabial region 3106, where the sealing layer 3102 is configured to engage the patient's nasolabial groove. This area of ​​the face is less sensitive than other areas of the face, and therefore a thicker or more rigid portion can be used to provide a stronger structure for sealing. Other areas of the sealing layer 3102 can include a softer or less rigid structure. For example, the flange 3107 of the sealing layer 3102 that can contact the patient's columella can be less rigid so as not to interfere with the patient.

[0385] In some forms, the stiffness or hardness of the sealing layer 3102 can be altered or determined by the amount or quantity of film material (e.g., thermoplastic material applied to the inner surface of the sealing layer 3102). In other forms, the stiffness or hardness of the sealing layer 3102 can be determined based on the amount of material used. For example, in some forms, the sealing layer 3102 includes bends or folds at specific locations that increase the thickness or density of the sealing layer 3102. Thus, by folding the material of the sealing layer 3102 in a specific manner, the rigid regions of the sealing layer 3102 may be formed without the need for additional film material or support.

[0386] The sealing layer 3102 can be secured to the base 3104. The base 3104 can include clips so that the seal-forming structure 3100 can be easily removed from a receptacle such as the frame 3152 of the patient interface 3000 (see, for example, FIG. Figure 6E ). Additionally, base 3104 can be harder or more rigid than sealing layer 3102. Thus, base 3104 can resist bending along the edges of sealing layer 3102 so that when sealing layer 3102 of seal-forming structure 3100 is depressed, the sides of sealing layer 3102 remain in a fixed position.

[0387] In addition, other forms of sealing layer 3102 may be used. For example, in some forms, a full face mask may be used rather than a sealing structure that provides air only to the nose. In other forms, a mask that provides air only to the mouth may be used. Various configurations may also be used. For example, in some forms, a single hole or aperture may be used rather than separate holes for each nostril. Furthermore, in some forms, the sealing structure may be designed to receive the nose, while in other designs, the sealing structure may be designed to abut the surface of the nose without enclosing or surrounding the nose. Additionally, the mask or sealing structure may be designed to be particularly comfortable. For example, in some forms, the nasal mask may be designed so that the patient's top or nasal protuberance is spaced from the mask. The nasal protuberance is typically a sensitive area of ​​the nose, so designing the mask so that the nasal protuberance is spaced from the mask can increase patient comfort.

[0388] A cross section of the sealing layer 3102 is depicted in FIG. Figure 6D and an enlarged view of a portion of the sealing layer 3102 is depicted in Figure 6D-1As shown, the membrane layer 3118 is positioned along the inner surface of the sealing layer 3102. The fabric sheet 3116 is positioned along the lower opposite surface of the sealing layer 3102. The thickness of the membrane layer 3118 can be determined or changed during the manufacturing process depending on manufacturing requirements. For example, a thicker membrane layer 3118 can provide greater rigidity than a thinner membrane layer 3118. A thinner membrane layer 3118 can allow the sealing layer 3102 to better adapt to the patient's face. In some forms, the thickness of the sealing layer 3102 is determined solely by the thickness of the membrane layer 3118 and the fabric sheet 3116. That is, in some forms, no other additional components such as reinforcers are used to maintain the shape of the sealing layer 3102. For example, the sealing layer 3102 can be easily deformed along all parts of the sealing layer 3102.

[0389] As before, the nasolabial junction area 3107 can have a different material thickness than adjacent portions of the sealing layer 3102. For example, a greater amount of film layer can be applied at the nasolabial junction area 3107 along the inner surface of the sealing layer 3102. The additional material can increase the thickness and stiffness of the nasolabial junction area 3107.

[0390] In addition to providing structure and support for the sealing layer 3102, the membrane layer 3118 can also contain air within the sealing layer 3102. That is, in some forms, the membrane layer 3118 can prevent air from passing through the material of the sealing layer 3102. Thus, the membrane layer 3118 can direct air from the therapeutic device to the nostril opening of the sealing layer 3102 and to the patient. Furthermore, as described later in other forms, the sealing layer 3102 can be designed to allow for a specific leak rate, such that a separate bleed or leak valve may not be required. Consequently, this feature can reduce manufacturing costs by removing components from the therapeutic device.

[0391] In some forms, the membrane layer 3118 can be a meltable material, such as a thermoplastic material or a thermosetting material. The material is capable of taking shape when melted into a mold or other form. As described in detail later in this specification and Figures 7A-7HAs shown, the film layer 3118 can be melted or partially melted (e.g., tacky) so that the material can conform to a specific shape. Once the film layer 3118 is melted, it is allowed to solidify into a shape (such as the shape of a mold). Once solidified, the film layer 3118 takes on the shape of the mold, so that the film layer 3118 has a predetermined shape. The film layer 3118 gives the shape of any material to which the film layer 3118 is laminated or adhered. For example, the film layer 3118 can make the fabric sheet 3116 take on the same shape as the film layer 3118 because the film layer 3118 is fixed to the fabric sheet 3116 and can conform to various shapes. The fabric sheet 3116 may also include such features that the fabric sheet 3116 includes a portion that can be melted and then conformed. The amount of pressure required to temporarily change the shape of the laminate of the sealing layer 3102 may depend on the thickness of the film layer 3118 and the material from which the film layer 3118 is formed.

[0392] In some forms of the present technology, the film layer 3118 can be formed from a thermosetting material. In addition, the sealing layer 3102 can include an additional laminate layer formed from a thermosetting material. An example of a thermosetting material is foam. A laminate with a thermosetting material can be placed in a mold and then subjected to heat. Thermosetting materials can be cured in a manner similar to thermoplastics. That is, thermosetting materials can be subjected to heat, and unlike thermoplastics, thermosetting materials can be irreversibly cured into a specific shape. If a more rigid or permanent structure is required, a thermosetting material can be used. The flexibility and hardness of the component (e.g., the sealing layer 3102) can be adjusted based on the selected material and the thickness of the thermosetting material. Because thermosetting materials can be cured into a specific shape, when used as a laminate with the sealing layer 3102, the shape of the sealing layer 3102 can also be formed into a specific shape.

[0393] Reference Figure 4P The sealing layer 3102, along with the base 3104 and the frame 3152, can be incorporated into a mask and air delivery system for use with therapy. As shown, the base 3104 can be attached to the assembly connection port 3154. The assembly connection port 3154 can provide air distribution to the sealing layer 3102 via the tube 3350.

[0394] The sealing layer 3102 can be lighter than other forms of technology and more comfortable for the patient than other forms of technology. In addition, because the fabric sheets, such as the fabric sheet 3116, can be stored in a flat or planar manner, the storage cost of the material can be less than other forms. In addition, using the mold 3112 (see Figures 7A-7G) can allow for the formation of complex shapes such as sealing layer 3102 while reducing costs. Unlike injection molding or extrusion molding, which require multiple complex parts and machinery, a lay-up process involving a mold such as mold 3112 provides a simple process that can reduce manufacturing time and costs. In addition, complex shapes can be formed relatively easily.

[0395] Furthermore, in some forms, the membrane layer 3118 used in forming the sealing layer 3102 can be the same material used in forming the fabric duct, as described later in this detailed description. By using the same material, the production cost of the various components can be reduced because larger quantities of material can be purchased in bulk.

[0396] See also Figure 4Q , depicts a possible assembly of a portion of a tube configured to interact with a seal-forming structure 3100. As shown, an assembly connection port 3154 is secured between the layers of the tube. The assembly connection port 3154 is sandwiched between the inner fabric layer 3452 and the outer fabric layer 3454. In addition, the assembly connection port 3154 extends through the outer foam layer 3456. In the configuration, an air passage or air duct is formed between the inner fabric layer 3452 and the outer fabric layer 3454, such that the assembly connection port 3154 is used to pass air from the air passage and through the outer foam layer 3456. In this way, the assembly connection port 3154 is secured by the inner fabric layer 3452 and the outer fabric layer 3454. The connection port 3154 can then be snap-fitted, friction-fitted, or otherwise secured to the frame 3152 to provide air to the patient.

[0397] 5.3.2.1 Method of forming a sealing structure

[0398] See also Figures 7A-7J , shows a method of forming a sealing structure. Figure 7A , mold 3112 includes a receiving portion 3114. Receiving portion 3114 can be in the shape of a sealing surface used in conjunction with a full face, nose, or other mask used with the therapeutic device.

[0399] See also Figure 7B and 7C , a fabric sheet 3116 is placed on the mold 3112. The fabric sheet 3116 can be formed of a material such as cotton, polyester, rayon, or other material or combination of materials. In addition, the configuration of the fabric sheet 3116 can also be formed into the same type of configuration as the sheets described in detail below, such as the inner layer 3352 and the outer layer 3426. That is, the fabric sheet 3116 can be woven, non-woven, knitted, braided, or any other fiber web. Although in Figures 7A-7HIt is not shown that the fabric sheet 3116 includes a fabric membrane before being placed in the receiving portion 3114 of the mold 3112, but in other forms, the fabric sheet 3116 can include a fabric membrane. In further forms, the fabric sheet 3116 can be pre-laminated with a fabric sheet 3116, such as with polyurethane or silicone.

[0400] After the fabric sheet 3116 is positioned along the mold 3112, the fabric sheet 3116 can be pressed into position within the receiving portion 3114. In some forms, rollers can be used to ensure that the fabric sheet 3116 is in a position such as Figure 7C and 7D In other forms, a vacuum seal can be used to pull the fabric sheet 3116 toward the receiving portion 3114. In other forms, another form of pressing the fabric sheet 3116 into the receiving portion 3114 can be used.

[0401] Once the fabric sheet 3116 is in place, as Figure 7E As shown, a membrane material may be placed along the upper surface of fabric sheet 3116. Membrane layer 3118 may be a thermoplastic or thermosetting material, silicone, polyurethane, or other material. The material of membrane layer 3118 may be sprayed as depicted, painted, or spread onto fabric sheet 3116, or may be pre-laminated onto fabric sheet 3116. Membrane layer 3118 may be a resin or other material that cures or solidifies through a chemical process or by exposure to air. As shown, membrane layer 3118 is a liquid thermosetting material. Membrane layer 3118 is deployed along the upper surface covering surface according to the manufacturer's needs. In some embodiments, the entire upper surface of fabric sheet 3116 may be uncovered. That is, in some cases, portions of fabric sheet 3116 may remain uncovered to provide easier attachment or fixing to other components. Furthermore, in other embodiments, fabric sheet 3116 may be a laminate and already include a surface formed by a membrane material.

[0402] Furthermore, the film layer 3118 can be thicker in some areas than in other areas. The film layer 3118 can be applied in liquid form at different rates to provide different thicknesses. Additionally, when formed as a separate solid layer, the film layer 3118 can be prefabricated to have areas that are thicker in some areas (e.g., the nasolabial junction 3107) than in other areas (e.g., the flange 3107).

[0403] Reference Figure 7F , the membrane layer 3118 and the fabric sheet 3116 may be exposed to heat. If the membrane material has already cured, the heat may melt the membrane layer 3118 and may also allow the membrane layer 3118 to unfold or layer uniformly along the fabric sheet 3116. In other forms, the membrane layer 3118 may be allowed to Figure 7E The steps shown are followed by curing without adding any additional heat to the system.

[0404] After the film layer 3118 is cured, Figure 7G As shown, the fabric sheet 3116 along with the cured membrane layer 3118 is removed from the mold 3112. Even when removed from the receiving portion 3114, the fabric sheet 3116 located within the receiving portion 3114 now takes on the shape of the receiving portion 3114. Because the membrane layer 3118 is a thermosetting material that can be cured into a specific shape, the sealing layer 3102 also takes on the same shape as the membrane layer 3118.

[0405] like Figure 7H As shown, the sealing layer 3102 is cut away from the remainder of the fabric sheet 3116. As shown, the sealing layer 3102 is cut away using scissors or shears, however, in other embodiments, the sealing layer 3102 may be cut using other techniques or devices, such as die cutting. In non-limiting examples, in some embodiments, the sealing layer 3102 may be cut away using a hot knife. In other embodiments, a die may be used to cut through the fabric sheet 3116.

[0406] As shown (see Figures 6A-6C ), a first nostril opening 3108 and a second nostril opening 3110 can be formed within the sealing layer 3102. The first nostril opening 3108 and the second nostril opening 3110 can be formed within the receiving portion 3114. That is, the receiving portion 3114 can be shaped to utilize peaks or valleys to influence the outer shape of the receiving portion 3114. By varying the shape of the receiving portion 3114, various shapes of the sealing layer 3102 are possible. In some embodiments, the fabric sheet 3116 can be pre-cut along the areas of the receiving portion 3114 corresponding to the first nostril opening 3108 and the second nostril opening 3110. In other embodiments, once cured, the material of the sealing layer 3102 can be cut away in the areas where the first nostril opening 3108 and the second nostril opening 3110 are located. Additionally, after the sealing layer 3102 is removed from the mold 3112, other post-processing can be performed on the sealing layer 3102.

[0407] In some embodiments, the fabric sheet 3116 may be pre-cut before being placed on the mold 3112. In such embodiments, the number of folds within the sealing layer 3102 of the seal-forming structure 3100 may be reduced compared to other embodiments. Figure 7I As shown, the fabric sheet 3116 is cut to form a pre-cut sheet 3117. The pre-cut sheet 3117 includes various notches 3120. These notches 3120 are specifically formed so that when the pre-cut sheet 3117 is placed within the mold 3112, the material of the pre-cut sheet 3117 can fold over and not overlap itself. That is, the pre-cut sheet 3117 can form an abutting joint as opposed to an overlapping seam. This can improve the user's comfort and tactile feel. For example, Figure 7I As shown, a notch 3122 is formed between a first fin 3124 and a second fin 3126 of the pre-cut material 3117. The lengths of the first fin 3124 and the second fin 3126 can be used to determine the height 3111 of the sealing layer 3102.

[0408] Now see Figure 7J After the sheet 3117 has been placed in the mold and cured with the film, the first flap 3124 and the second flap 3126 can be folded upward according to the mold shape. When folded, the first flap 3124 and the second flap 3126 can abut each other in the area of ​​the notch 3122. Based on the geometry of the sealing layer 3102, the shape and size of the notch 3122 can be changed to allow for a variety of designs and configurations. Figure 7J As shown, the first wing 3124 and the second wing 3126 do not overlap each other. However, in other forms, the wings may be designed to overlap each other to provide increased stiffness in specific areas (e.g., the nasolabial junction area 3107).

[0409] like Figure 7I and 7J The configuration shown can provide smooth inner and outer surfaces of the sealing layer 3102. In addition, by cutting the fabric sheets prior to molding, the amount of time used to arrange the fabric sheets within the mold can be reduced compared to other forms in which the fabric sheets can be folded to fit within the mold.

[0410] 5.3.3 Positioning and stabilizing the structure

[0411] The seal-forming structure 3100, 9100 of the patient interface 3000, 6000, 7000, 8000, 9000, 10000 of the present technology may be maintained in a sealed condition during use by a positioning and stabilizing structure 3300, 7300, 8300, 9300. The positioning and stabilizing structure may include or be referred to as a "headgear" because it engages the patient's head to maintain the patient interface in a sealed position.

[0412] In one form, the positioning and stabilizing structure provides a retaining force that is at least sufficient to overcome the effect of the positive pressure in the inflatable chamber 3200, 9200 to lift off the face.

[0413] In one form, the positioning and stabilising structure provides a retaining force to overcome the effects of gravity on the patient interface.

[0414] In one form, the positioning and stabilizing structure provides a retaining force as a safety margin to overcome the potential effects of damaging forces on the patient interface, such as from tube drag or accidental interference with the patient interface.

[0415] In one form of the present technology, a positioning and stabilizing structure is provided that is configured in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilizing structure has a small lateral or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilizing structure includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure includes at least one flat strap.

[0416] In one form of the present technology, a positioning and stabilizing structure is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a supine sleeping position with the back area of ​​the patient's head on a pillow.

[0417] The positioning and stabilizing structure may include at least one tether. A tether will be understood to be a structure designed to resist tension. In use, the tether is part of the positioning and stabilizing structure that is under tension. As will be described, some of the tethers will exert an elastic force due to the tension. The tether can be used to maintain the seal-forming structure in a therapeutically effective position on the patient's head. In some forms of the present technology, the positioning and stabilizing structure may include tethers in the form of headband tubes and / or headband straps, as will now be described.

[0418] In one form of the present technology, the positioning and stabilizing structure includes a first strap that is constructed and arranged such that, in use, at least a portion of a lower edge of the first strap passes above the supra-auricular base of the patient's head and covers a portion of the parietal bone without covering the occipital bone. The first strap may be provided, for example, as part of a patient interface including a cradle cushion, nasal pillows, nasal cushions, full-face cushions, or oronasal cushions. For example, the positioning and stabilizing structure may include a first strap in the form of a gas delivery tube that is positioned on top of the patient's head. The gas delivery tubes may also be referred to as headband tubes because they provide the functionality of a headband.

[0419] In one form of the present technology adapted for use with a nasal-only mask or a full-face mask, the positioning and stabilizing structure includes a second strap constructed and arranged such that, in use, at least a portion of an upper edge of the second strap passes below a subauricular point on the patient's head and overlies or lies below the occipital bone of the patient's head. The second strap may be provided, for example, as part of a patient interface including a cradle cushion, nasal pillows, full-face cushion, nasal cushion, or oronasal cushion. For example, the positioning and stabilizing structure may include a second strap in the form of a strap that rests against the posterior surface of the patient's head.

[0420] In one form of the present technology adapted for use with a nasal-only mask or with a full-face mask or an oronasal mask, the positioning and stabilizing structure includes a third strap configured to anchor against a posterior surface of the patient's neck. Additionally, in some forms, the positioning and stabilizing structure includes a fourth strap constructed and arranged to interconnect with the second and third straps to reduce a tendency for the second and third straps to move away from each other.

[0421] In some forms of the present technology, the positioning and stabilizing structure includes a strap that is flexible and, for example, non-rigid. An advantage of this aspect is that the strap is more comfortable for the patient to lie on while sleeping. The positioning and stabilizing structure may include a flexible strap. The strap may be considered a back strap. The strap is flexible enough to pass around the back of the patient's head and rest comfortably against the patient's head, even when under tension during use.

[0422] In some forms of the present technology, the positioning and stabilizing structure includes a strap that is configured to be breathable to allow moisture vapor to be transmitted through the strap.

[0423] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure, each positioning and stabilizing structure configured to provide a retention force corresponding to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure that is suitable for large heads but not for small heads, while another form of positioning and stabilizing structure is suitable for small heads but not for large heads.

[0424] In certain forms, the positioning and stabilizing structure may include a gas delivery tube to deliver pressurized breathable gas to the patient's airway via the mask interface (e.g., cushion module), and may therefore be referred to as a "conduit headgear."

[0425] For example, reference Figure 4B , a patient interface is shown. As shown, the patient interface 3000 includes a gas delivery tube, described as a tube 3350, which extends around the patient's head above the ears along the parietal bones and reaches the seal-forming structure 3100. The tube 3350 can deliver air to the seal-forming structure 3100 and support the seal-forming structure 3100 in place. Thus, the tube 3350 can serve as both a support structure and an air conduit. For example, in other forms, a separate tube, such as the air delivery tube 3348, can be directly attached to the seal-forming structure 3100 and not extend around the patient's head. In this form, the tube is not supported by the patient's head, and the tube does not provide support to the seal structure. This form also includes a separate strap for supporting the seal structure.

[0426] The patient interface 3000 includes a head strap 3420 attached to the tube 3350 of the patient interface 3000. The head strap 3420 can be used to support the tube 3350 and help provide correct positioning of the patient interface 3000. The head strap 3420 can provide tension on the tube 3350 so that the tube 3350 does not fall forward or in front of the patient's face during normal use. In addition, the head strap 3420 can work with the tube 3350 to provide sufficient upward force to the sealing structure 3100 to help maintain the sealing structure 3100 in the correct position relative to the patient's face so that the sealing layer 3102 is adequately sealed to the patient's air opening. Therefore, the stabilizing structure 3300 can include at least the tube 3350 and the head strap 3420.

[0427] In some forms, the head strap 3420 may be directly and permanently attached to the tube 3350. That is, removing the head strap 3420 from the tube 3350 will damage one or both of the head strap 3420 and the tube 3350. Figure 5A As shown, the head strap 3420 is directly attached to the tube 3350 between the inner and outer layers of the tube 3350. In some embodiments, the head strap 3420 does not require sewing. For example, in some embodiments, the head strap 3420 is sandwiched between the inner and outer layers of the tube 3350, and this area is heated. The inner and outer layers of the tube 3350 may comprise a thermoplastic or thermosetting material that changes when heated. Thus, when heated, the material may melt or soften, allowing it to interact with the head strap 3420. When the material solidifies, the head strap 3420 is secured between the tabs of the tube 3350. In other embodiments, the head strap 3420 may include a removably attachable portion, such as a hook-and-loop fastener. In such embodiments, the tube 3350 may include a slot through which the head strap 3420 can pass. The patient can then adjust the fit of the patient interface 3000 by shifting the tabs of the head strap 3420 and securing the strap in place. In other versions, an adjustable string or cord or line may be utilized to comfortably fit the patient interface 3000 on the patient's head.

[0428] As shown, the seal-forming structure 3100 extends to the patient's nose while keeping the mouth free from obstruction. Some patients may prefer a patient interface that includes a specific type of mask, such as Figures 4A-4D As shown, this allows patients to switch between them while receiving treatment. Other patients may prefer a full-face mask or a mask that surrounds the mouth, depending on need or comfort. Various forms of this technology can be used, depending on the patient's specific use. Although described as a nasal mask, a full-face mask can also be used.

[0429] In some forms, the seal structure includes a base 3104 that allows the seal-forming structure 3100 to be removably attached to the frame 3152. The base 3104 may include a clip mechanism that enables the seal-forming structure 3100 to be attached to the frame 3152 (see Figure 4P ). The frame 3152 may include attachment points or locations to which the tube 3350 may be attached. Thus, air may enter the frame 3152, then pass through the seal-forming structure 3100 and ultimately reach the patient.

[0430] In other forms, different frames may be used. For example, in some forms, the frame may include various slots or attachment points so that the frame can interact with straps such as straps from the head strap 3432. For example, although in Figure 4A Not shown in FIG, the frame may include a forehead support including a slot for interacting with the strap. Figure 5F As shown in , a lower groove adjacent to a structure such as a seal-forming structure 3100 can be used to interact with a head strap and allow for an adjustable fit of the headband or stabilizing structure 3300.

[0431] In one form of the present technology, the positioning and stabilizing structure 3300, 7300, 8300, 9300 is provided with a decoupling portion located between the front portion of the positioning and stabilizing structure and the rear portion of the positioning and stabilizing structure. The decoupling portion does not resist compression and may be, for example, a flexible strap or floppy strap. The decoupling portion is constructed and arranged such that when a patient lies with their head on the pillow, the presence of the decoupling portion prevents forces acting on the rear portion from being transferred along the positioning and stabilizing structure and disrupting the seal.

[0432] In one form of the present technology, a positioning and stabilizing structure comprises a strap constructed from a laminate of a textile inner layer, a foam inner layer, and a textile outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer comprises a loop material for engaging with a hook material portion.

[0433] In some forms of the present technology, the positioning and stabilizing structure includes a strap that is extendable, such as elastically extendable. For example, the strap can be configured to be in a tensioned state during use and to direct a force to seal the seal-forming structure against a portion of the patient's face. In one example, the strap can be configured as a tie.

[0434] 5.3.3.1 Positioning and Stabilizing Structures According to Examples of the Present Technology

[0435] 5.3.3.1.1 Headband tube

[0436] exist Figure 4BIn the illustrated form of the present technology, the patient interface 3000 includes at least one tube 3350 that delivers pressurized air received from a conduit, such as an air delivery tube 3348 forming part of the air circuit 4170, from the RPT device to the patient's airway. For example, through the plenum 3200 and the seal-forming structure 3100. The tube 3350 is an integral part of the headgear 3300 of the patient interface 3000 to position and stabilize the seal-forming structure 3100 of the patient interface to the appropriate portion of the patient's face (e.g., nose and / or mouth). This allows the air delivery tube 3348, which provides the pressurized air flow, to be connected to the connection port 3600 of the patient interface at a location other than the front of the patient's face, which may be unsightly for some people.

[0437] The positioning and stabilizing structure 3300 can be described as airtight or air retaining because air can be contained and passed through the tube 3350 to deliver pressurized air from the air circuit 4170 to the patient's airway. It should be understood that an airtight or air retaining positioning and stabilizing structure 3300 does not require that all components of the positioning and stabilizing structure 3300 be airtight.

[0438] In some forms of the present technology, the patient interface 3000 may include a connection port 3600 located near the top, side, or back of the patient's head. Figure 4B In the form of the present technology shown, the connection port 3600 is located at the top of the patient's head when in use. A patient interface in which the connection port is not positioned at the front of the patient's face may be advantageous because some patients find the conduits connected to the patient interface at the front of the face unsightly and obtrusive. For example, the conduits connected to the patient interface at the front of the face may tend to become tangled in bedding or sheets, particularly if the conduits extend downward from the patient interface during use. Forms of the technology using a patient interface with a connection port may make it easier or more comfortable for the patient to be in one or more of the following positions: in a side-lying or lateral position; in a supine position (i.e., lying on their back with their face up); and in a prone position (i.e., lying on their stomach with their face down). In addition, connecting the conduits to the front of the patient interface may also give rise to a problem known as tube drag, in which the conduits may provide an undesirable drag on the patient interface, causing them to move away from the face.

[0439] exist Figure 4A 、 4B In the example of FIG-4D, at least one tube 3350 extends from the connection port 3600 between the cushion assembly 3150, through the cheek area of ​​the patient and above the patient's ear, that is, a portion of the tube 3350 connected to the cushion assembly 3150 covers the maxillary area of ​​the patient's head during use, and a portion of the tube 3350 covers an area of ​​the patient's head above the supra-auricular base point of the patient's head. Figure 4A and4B In some embodiments shown in FIG4D , the tube 3350 is positioned along both sides of the user's face. That is, for example, the tube 3350 extends through the right cheek region and the left cheek region of the patient.

[0440] exist Figure 4B In the form of the present technology shown, the positioning and stabilizing structure 3300 includes a single tube 3350, which includes a right portion and a left portion, each portion being positioned on a different side of the patient's head in use and extending across the corresponding cheek area, above the corresponding ear (above the supraauricular base of the patient's head) to a connection port 3600 on the top of the patient's head. This form of technology can be advantageous because if the patient sleeps with their head on their side and one of the tubes is compressed to block or partially block the flow of gas along that tube, the other tube remains open to supply pressurized gas to the patient. In other embodiments of the technology, the patient interface can include a different number of tubes, such as one tube, or three or more tubes.

[0441] like Figure 4B As shown, the patient interface has a single tube 3350. The single tube 3350 is positioned on one side of the patient's head (e.g., across one cheek area) during use, and the head strap 3420 forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head (e.g., across another area) during use to help secure the patient interface 3000 to the patient's head. As shown, the tube 3350 extends continuously from one side of the cushion assembly 3150 to the connection port 3600 and back to the other side of the cushion assembly 3150.

[0442] like Figure 4B As shown, the left arm 3302 and the right arm 3304 are connected to each other in a continuous manner. That is, there is no specific connection point between the left arm 3302 and the right arm 3304. Instead, the fluid connection extends seamlessly between the two arms. By forming the tube 3350 continuously, the number of components of the patient interface 3000 can be reduced compared to other forms of the present technology.

[0443] exist Figures 4A-4DIn an exemplary form of the technology shown, the tube 3350 curves around the upper portion of the patient's head from the upper end of the tube 3350. The tube 3350 includes a connection port 3600 on the top of the head to a tab 3346 where the rear headgear strap 3420 connects to the tube 3350, without substantially any bend in the coronal plane. Between the tab 3346 where the rear headgear strap 3420 connects to the tube 3350 and the lower end of the tube 3350, where the tube 3350 connects to the cushion assembly 3150 located in front of the patient's airway below the nose, the tube 3350 curves forward or anteriorly between the patient's ears and eyes and across the cheek area. The radius of curvature of this portion of the tube 3350 can be in the range of 60-100 mm, such as 70-90 mm, for example 80 mm. The lower end of the tube 3350 and the portion of the rear of the tube 3350 where the headgear strap 3420 connects to the tube 3350 may subtend an angle in the range of 65-90°, such as 75-80°.

[0444] exist Figures 4A-4D In the exemplary form of the technology shown, the tube 3350 extends substantially vertically in an upward direction (i.e., upward) from near the base point on the ear to the connection port 3600. That is, the tube 3350 is at an angle of between 0 and 15 degrees to the coronal plane in the region between the base point on the ear and the connection port 3600. In other forms, the angle can be greater depending on the patient's positioning. In addition, the tube 3350 is formed so that the tube 3350 has a greater angle from the base point on the ear of the patient to the airway relative to the sagittal plane.

[0445] In addition, if Figures 4B-4DAs shown, tube 3350 includes a connection port 3600. Connection port 3600 can be partially located within tube 3350. That is, a portion of connection port 3600 extends through outer layer 3354 and between outer layer 3354 and inner layer 3352 of tube 3350. In this manner, connection port 3600 is sandwiched between the layers of tube 3350. Connection port 3600 can be configured to connect to other tubes, such as air delivery tube 3348 of a treatment device that provides air flow from air circuit 4170. In some embodiments, air delivery tube 3348 can form the entirety of air circuit 4170, while in other embodiments, air delivery tube 3348 forms a portion of air circuit 4170. Air delivery tube 3348 can be formed from a variety of materials, including fabric, silicone, and other materials. By integrating connection port 3600 within tube 3350, the number of seams or connection points along tube 3350 can be reduced compared to other embodiments of the present technology. In addition, by integrating the connection port 3600 into the tube 3350, the use of additional connection mechanisms such as adhesives, fasteners, or other additional mechanism features can be minimized or eliminated. In other forms, the connection port 3600 includes an inner portion and an outer portion. The inner portion can be located between the inner layer 3352 and the outer layer 3354. The outer portion interacts with the inner portion such that the outer layer 3354 is sandwiched between the inner and outer portions of the connection port 3600.

[0446] In some forms, fabric is used to form various components of the stabilizing structure 3300. As shown, tube 3350 is formed of a fabric material. Some patients may find the silicone tube uncomfortable during use when the tube is against the patient's face. Additionally, even when a sleeve or stocking of fabric material is placed over the silicone tube, the patient may find the silicone tube uncomfortable. The thickness and weight of the silicone tube may cause the patient to stop using the device. Furthermore, the silicone tube may wrinkle or bend when the patient lies headfirst, making the thickness of the tube easily felt on the patient's face even when covered with a fabric sleeve. Fabric conduits or tubes, such as tube 3350, may increase comfort for some patients.

[0447] The fabric material can be a flat sheet of material, or the fabric material can be formed into a three-dimensional configuration so that the fabric material has positive curvature or negative curvature. " Fabric material " or " fabric " used in this specification can be used to describe any fiber web. For example, the fabric material or fabric can be a fiber web that is woven, nonwoven, knitted, braided or any other form. Fabric materials of different configurations can be used for different properties. For example, a woven configuration can be used for specific transverse and longitudinal strength, and a knitted structure can be used for flexibility and stretchability. In addition, in some forms, the fabric material can combine different configurations to achieve specific characteristics. In addition, the density of the material can vary depending on the various properties required. For example, if greater stretching is required, a less dense fiber network can be used.

[0448] In addition, fabrics can be formed from a variety of materials. Fabrics can be formed from natural or synthetic materials. Some examples include cotton, rayon, polyester, linen, silk, leather, polyurethane, monofilament or multifilament materials, or any combination of materials in addition to other materials. Materials can be selected based on tactile feel, texture, stiffness, flexibility, ductility, and other factors. In addition, fabrics can include natural and synthetic materials. Natural fibers or strands, such as cotton, can be used to provide a soft touch and a comfortable fit for the patient. Synthetic fibers can be used to provide stiffness or strength and other properties to specific areas of the fabric.

[0449] In some forms of this technology, different materials can be used within the same fabric material. Different materials can be used to provide specific properties to a fabric component. For example, stretchable fibers, strands, or yarns can be included in a fabric in a specific orientation to provide strength in the longitudinal, or first, direction. Secondary fibers that are substantially inextensible, non-stretchable, or stretch-resistant can be included in the fabric in the transverse, or second, direction. In this way, the fabric can be anisotropic with different properties in different directions to provide support for specific components. For example, a tube can be formed from a fabric material. The fabric material can be configured to expand or stretch in a first direction when subjected to pressure. In a second direction, different from the first, the fabric material can be configured to resist stretching or deformation when subjected to pressure or force. For example, the tube can be configured so that the fabric material expands radially when subjected to air pressure. This stretching allows the tube to accept or receive air and also allows the tube to rest comfortably against the patient. However, the tube can have a specific longitudinal orientation along the patient's face, making longitudinal stretching undesirable. By fixing or limiting stretching in the longitudinal direction, the tube's positioning can be maintained, allowing the patient to receive consistent treatment.

[0450] In some forms, the fabric tube may be formed from one or more sheets or layers of fabric material. In some forms, a single sheet may be folded or rolled and secured to itself along the side edges of the sheet, such that the tube is formed with a single seam. In other forms, more than one sheet is used. For example, a fabric tube may be formed with a first side configured to contact a patient. This may be referred to as the inner layer. The fabric tube may also include a second side that is attached to the inner layer but faces away from the patient, which may be referred to as the outer layer. The inner and outer layers may each be secured to one another along the edges of the inner and outer layers, such that a channel or passageway is formed between these seams of the inner and outer layers. That is, the space between the seams remains unattached.

[0451] As discussed in this detailed description, each of the inner and outer layers includes an inner surface and an outer surface. The inner surface of the inner layer is the surface that faces the outer layer. The inner surface of the outer layer is the surface that faces the inner layer. Similarly, the outer surface of the outer layer faces away from the inner layer, and the outer surface of the inner layer faces away from the outer layer. Furthermore, in a form comprising a single sheet, the inner surface is the surface of the sheet that faces inward and toward itself.

[0452] In some embodiments, one or more of the sheets of material in the tube may include an air-impermeable layer or fabric membrane. In some embodiments, the inner surfaces of both layers include a membrane configured to restrict or constrain air from passing through the layers from the inner surface to the outer surface. The impermeable layer may be a thin layer that is thinner than the thickness of the fabric sheets in either the inner or outer layer. In other embodiments, the impermeable layer may be thicker than the thickness of the fabric sheets in either layer. This impermeable layer, fabric membrane, or film may be completely impermeable to air transmission, or may be formed to allow a predetermined rate or amount of air transmission and a specific pressure. In further embodiments, the membrane may be specifically designed to allow a certain amount or quantity of air, water vapor, or moisture vapor to pass through the fabric, rendering the tube 3350 breathable, allowing moisture to escape and / or pass through it. By removing air through the membrane, the need for a separate bleed valve for exhaust can be eliminated, as air can escape through components (e.g., the duct conduit or the sealing structure itself). Furthermore, in some embodiments, permeability can be adjusted in specific areas. For example, permeability can be varied along the cheek area of ​​the tube 3350. This area may become hot during use and cause discomfort to the user. The permeability can be varied to allow some air to pass through the tube 3350 to the patient's skin, thereby causing a cooling effect. The type of membrane and the permeability of the membrane can be varied or adjusted depending on the nature or use of the fabric in which the membrane is located.

[0453] In some forms, the thickness of the fabric membrane can vary. In some forms of the present technology, the fabric membrane can be less than 5% of the fabric thickness. In other forms, the thickness of the fabric membrane can be between 5% and 25% of the fabric thickness. In further forms, the thickness of the fabric membrane can be between 25% and 50% of the fabric thickness. In addition, the thickness of the fabric membrane can be between 50% and 100% of the fabric thickness or more. Varying the thickness of the fabric membrane affects the stiffness and stretchability of the fabric. For example, a fabric comprising a fabric membrane that is 1% of the fabric thickness can be less rigid and more stretchable than a fabric comprising a fabric membrane that is more than 50% of the fabric thickness. In some forms, a thicker fabric membrane can be used to provide additional strength in specific areas of the catheter or sealing interface. That is, the thickness of the fabric membrane can be increased in high stress areas or areas that are more likely to experience kinking or folding during use.

[0454] The membrane may be formed of a thermoplastic or thermosetting material such that when exposed to a specific temperature, the membrane material can be molded or formed into a specific form and then solidify or set or congeal upon cooling. In some forms, the membrane may be formed of silicone or polyurethane.

[0455] Additionally, in some embodiments, a film material can help connect the seams of the layers together. For example, a thermoset or thermoplastic material can crosslink, as in the case of thermoset materials, or melt, as in the case of thermoplastic materials, when exposed to a specific amount of heat. Upon curing, the materials can bond together. For example, a film along the inner surface 3356 of the outer layer 3354 and a film along the inner surface 3358 of the inner layer 3352 can be heated along the edges of the outer layer 3354 and the inner layer 3352 to form a seam between the two layers.

[0456] The inner layer can be attached to the opposing outer layer along a first seam and a second seam. Once the layers are attached to each other, a tube or conduit can be formed between the two layers. By securing the layers along these edges, a central chamber is formed that allows air or other gaseous or liquid media to flow when secured with the air circuit 4170.

[0457] like Figure 4BThe illustrated tube 3350 is formed using a fabric comprising a membrane. Tube 3350 includes an inner layer 3352 and an opposing outer layer 3354. Both inner layer 3352 and outer layer 3354 include an impermeable membrane along the inner surfaces of these layers. Although described and illustrated as including only the inner surface coated with the impermeable layer, in some embodiments, both the inner and outer surfaces of the layers of tube 3350 may include an impermeable membrane. However, in some embodiments, the impermeable membrane may be oriented away from the patient's face. By orienting tube 3350 in this manner, the soft touch of the textile can be pressed against the patient while the impermeable membrane layer is separated from the patient. This allows the formation of a single piece of material having different properties depending on the side of the material used. This can reduce production costs and the time required or needed to form the component.

[0458] 5.3.3.1.1.1 Tube shape and composition

[0459] refer to Figure 4F , depicting a cross-section of tube 3350. In some forms, inner layer 3352 and outer layer 3354 may be formed from multiple layers of fabric material and / or membrane material. By varying the thickness and composition of the layers of tube 3350, different properties may be achieved. Figure 4F ,in particular Figure 4F-1 As shown, the inner layer 3352 includes a fabric sheet 3360 and a fabric membrane 3362. The fabric sheet 3360 can be formed from felt, spacer textiles, foam, woven, knitted or nonwoven materials or other fiber webs. As shown, the fabric sheet 3360 is a felt-type fabric. In this way, the outer surface 3374 of the inner layer 3352 can have a soft touch against the patient's face. The outer layer 3354 is composed of multiple pieces of fabric. The outer layer 3354 includes a tube sheet 3364 and an outer cover layer 3366. In some forms, both sides of the tube sheet 3364 can be covered with a fabric membrane. As shown Figure 4F-2 As shown, the tube sheet 3364 includes a fabric membrane 3368 exposed to the chamber of the tube 3350 and a fabric membrane 3370 along the opposite surface of the tube sheet 3364. The fabric membrane 3368 can help provide a seal between the inner layer 3352 and the outer layer 3354 and form an airtight tube. The fabric membrane 3370 can help connect the tube sheet 3364 to the outer cover layer 3366. In other forms, the tube sheet 3364 can be directly bonded or connected to the outer cover layer 3366. In other forms, the outer layer 3354 includes a shape-retaining material or materials that can be thermoformed, such as a foam layer located between the tube sheet 3364 and the outer cover layer 3366. In other forms, the tube sheet 3364 can be thermoformed. As discussed in detail later in this detailed description, the shape-retaining material can be used to provide the tube 3350 with a predetermined shape.

[0460] The configuration, orientation, and composition of the sheets of inner layer 3352 and outer layer 3354 can help provide structural support to the tube 3350 to prevent occlusion during use. Figure 4F As shown, the cross-section of tube 3350 is substantially D-shaped, forming an air passage 3372 between inner layer 3352 and outer layer 3354. Inner layer 3352 is substantially planar, resulting in zero curvature. Outer layer 3354 curves away from inner layer 3352, resulting in an inner surface 3356 of outer layer 3354 having a positive curvature between the joints. As shown, the curvature of inner surface 3356 varies between the joints of tube 3350. That is, the curvature can be negative near the point where inner layer 3352 and outer layer 3354 are joined. However, it should be understood that the overall curvature, when taken from the center point between the connecting edges of tube 3350, is positive. In other words, outer layer 3354 has a non-planar configuration that forms an arcuate portion in cross-section between the connecting edges. That is, inner surface 3356 of outer layer 3354 can have a concave shape, while outer surface 3376 of the outer layer can have a convex shape. The curvature of the outer layer 3354 can be fixed so that when the outer layer 3354 is not subjected to a force (such as weight by an external force or air pressure), the inner surface 3356 of the outer layer 3354 has a substantially positive curvature. Thus, the inner layer 3352 and the outer layer 3354 are asymmetrical, as opposed to some conventional catheter sections that have the same or symmetrical shape.

[0461] Furthermore, the inner surfaces of the inner layer 3352 and the outer layer 3354 may be D-shaped in cross-section. That is, the inner surfaces may define D-shaped air passageways 3372. Thus, in some forms, the inner surfaces of the inner layer 3352 and the outer layer 3354 may form a D-shape in cross-section, and the outer surfaces of the inner layer 3352 and the outer layer 3354 may also form a D-shape in cross-section.

[0462] In another embodiment, the outer layer 3354 can be curved away from the inner layer 3352. Figure 4F As shown, the outer layer 3354 and the inner layer 3352 are attached to each other along the longitudinal edges so that the edges of the inner layer 3352 and the outer layer 3354 are flush with each other. Between these attachment points, adhesion areas or joints, the outer layer 3354 bends away from the inner layer 3352. That is, between the joints 3312 (see FIG. Figure 4H ), the inner surface 3356 of the outer layer 3354 is positioned away from the inner surface 3358 of the inner layer 3352. In some forms, the outer layer 3354 can be pre-formed such that, in an unpressurized or unsupported state, the outer layer 3354 is pre-positioned and pre-shaped to extend away from the inner layer 3352 between the opposing joints 3312. That is, the outer layer 3354 can support its own weight such that, when not supported by compressed air or other supporting mechanisms, the outer layer 3354 remains spaced apart from the inner layer 3352 between the joints 3312.

[0463] The generally D-shaped cross-section may vary along its length, e.g., a tall, thin D-shaped cross-section near the patient's nose and a wide, shallow D-shaped cross-section along the cheeks and near the top of the patient's head. Figures 4I-4K Various cross sections of a tube 3350 along its length are shown according to one form of the tube 3350. As shown, the D-shape of the cross section varies along its length. Specifically, each cross section has a width w and a height h, and the width and height of the various cross sections vary along the length of the tube, for example, a relatively long width and short height at the manifold end compared to a relatively short width and high height at the interface structure end. In some forms, the D-shaped cross section of the tube 3350 can be asymmetric along the entire length of the tube or at least along one or more portions of the tube. In addition, all cross sections have a very similar or common hydraulic diameter, for example, about 10-15 mm or about 13 mm. In addition, the width and height may refer to the chamber dimensions, rather than the overall dimensions of the cross section including the external seam area.

[0464] In addition, the tube 3350 can provide a flatter area in certain areas, for example, areas where the patient rests on the tube during sleep. In this way, the tube can be said to be an organic extension of the patient's facial contours. The shape can be configured based on aesthetics and / or impedance requirements. In addition, the shape can be configured to provide a smaller profile, comfort and / or stability. However, the tube 3350 may have other suitable cross-sectional shapes, for example, trapezoidal, semicircular, cylindrical, oval, elliptical, a flatter cross-section, etc. In addition, the tube can have a flat configuration with anti-extrusion ribs. Such an arrangement is disclosed in U.S. Patent No. 10 / 385,701, the entire contents of which are incorporated herein by reference.

[0465] In addition, if Figures 4L-1 to 4L-4 The illustrated tube 3350 may be flexible, allowing it to easily deform under finger pressure. That is, the tube 3350 may not be formed from a rigid, indestructible structure. Instead, the tube 3350 is formed so that it can deform under finger pressure. However, the tube 3350 can maintain its shape even without air pressure or other forces.

[0466] In addition, the outer layer 3354 can be an elastic structure. The outer layer 3354 can be deformed when subjected to pressure or force during normal use to adapt to the patient's activities during sleep and use. For example, the tube 3350 can collapse so that the outer layer 3354 presses against the inner layer 3352 not only at the sealing edge, but also between the sealing edges. However, when the force is removed from the outer layer 3354, the outer layer 3354 can return to its predetermined shape of the inner surface including a positive curvature. That is, the outer layer 3354 is not a floppy structure because the outer layer 3354 can support its own weight without changing its shape (e.g., by bending or twisting). The outer layer 3354 can have a hardness between Shore hardness 0010 and Shore hardness 0030. In other forms, the outer layer 3354 can be harder so that the outer layer 3354 is configured to resist greater forces.

[0467] Outer layer 3354 can comprise a material that resists plastic deformation. For example, outer layer 3354 can be bent or folded so that, when subjected to a force, portions of outer surface 3376 can lean against themselves. However, once the force is released, outer layer 3354 returns to its pre-force shape. Rather than plastically deforming or failing, outer layer 3354 elastically deforms and returns to its predetermined shape. Furthermore, a large portion of tube 3350 can be bent, folded, or twisted in a similar manner. That is, tube 3350 can be formed from a material that does not plastically deform when folded onto itself.

[0468] In contrast, the inner layer 3352 can be a flexible component. The inner layer 3352 can be attached and fixed to the edge of the outer layer 3354, so that the inner layer 3352 is a substantially planar layer. The shape of the inner layer 3352 can be affected by the shape of the outer layer 3354. As shown, due to the force applied to the inner layer 3352 through the seam of the tube 3350, the inner layer 3352 can be planar. Because the outer layer 3354 resists deformation, the outer layer 3354 can maintain the tightness of the inner layer 3352, so that the inner layer 3352 is planar. In other forms, the inner layer 3352 can be cut so that the inner layer 3352 is wider than the outer layer 3354, but the inner layer 3352 is still connected to the outer layer 3354 along the edge of the tube 3350. In this form, the unfixed portion of the inner layer 3352 can move inward toward the outer layer 3354.

[0469] In some forms, the inner layer 3352 can be soft in some areas and rigid in other areas. For example, in some forms, a reinforcer can be used within the arm support 3314 to impart rigidity to the inner layer 3352 so that the inner layer 3352 is not soft in specific areas. However, in some forms, the inner layer 3352 can remain soft between the seals of the tube 3350. That is, no additional reinforcers are used between the seals or joints of the tube 3350. The reinforcers can have a hardness between Shore A 30 and Shore A 90 or higher.

[0470] In other forms, the inner layer 3352 can be at least semi-elastic. That is, while the inner layer 3352 may not be able to support its own weight, the inner layer 3352 may be able to support some of its own weight with assistance from the outer layer 3354, such that the inner layer 3352 remains in substantially the same position when not subjected to additional forces (e.g., air pressure or other external forces).

[0471] The inner layer 3352 is depicted as being relatively flat and adapted to rest substantially flush against the patient's face during use. The inner layer 3352 can have a tapered configuration from the inner edge to the outer edge to provide a comfortable fit for a wide range of patients. The inner layer 3352 provides a relatively large surface area, which results in a more even load distribution. This arrangement is less likely to create pressure points during use. In addition, the inner layer 3352 can have a grip-like material to help stabilize the patient interface on the patient's face.

[0472] In some forms, the outer layer 3354 can be more resilient than the inner layer 3352. That is, the outer layer 3354 can be more resistant to deformation than the inner layer 3352. In addition, the outer layer 3354 can return to a predetermined shape more easily than the inner layer 3352. In addition, in some forms, the outer layer 3354 can be harder or more rigid than the inner layer 3352. Figures 4F to 4F-2 As shown, the outer layer 3354 can include more layers than the inner layer 3352, and the outer layer 3354 can have a greater thickness than the inner layer 3352. This configuration of the outer layer 3354 and the inner layer 3352 can help provide a relatively harder or more rigid outer layer 3354. The increased hardness, stiffness, and / or elasticity can help maintain an open path through which air can travel. Additionally, in some forms, the outer layer 3354 can include a harder material than the inner layer 3352. The material combination can help provide a harder or more rigid outer layer 3354.

[0473] The outer layer 3354 has a smooth contour that blends with the patient's face. That is, the outer layer 3354 has sides or an organic form whose edges blend into the patient's face, for example, in a tangential manner, to prevent any edges from catching on bedding, pillows, etc. during sleep (e.g., when the patient turns over). As shown, the tube 3350 has a non-cylindrical cross-sectional shape that provides a blending contour to blend with the patient's face (see Figures 4A-4D ). The fusion profile is smooth, streamlined, sleek, and blends or tapers the tube 3350 with the contours of the patient's head, e.g., anatomically continuous, less obtrusive, and more aesthetically pleasing. In addition, the fusion profile has no sharp edges that may cause discomfort (e.g., skin irritation or friction).

[0474] In some forms, the outer layer 3354 can be thermoformed so that the material within the outer layer 3354 takes the shape of a mold or mandrel. When cured or cooled, the thermoformed material takes on the shape of a mold or mandrel. Figure 4F The shape shown. In some embodiments, an additional layer may be positioned between the outer cover layer 3366 and the tube sheet 3364. In some embodiments, the additional material may be foam or another thermoset material. In other embodiments, the tube sheet 3364, the outer cover layer 3366, or both may be formed from foam or a thermoset material. In other embodiments, thermoplastic materials may be used. In other embodiments, any other shape-retaining material may be used. As shown, the cross-sectional shape of the tube 3350 can be maintained outside of the outer and inner layers 3352 without additional reinforcements or components. Furthermore, the thickness of the inner layer 3352 can be substantially uniform across its width. Furthermore, the thickness of the outer layer 3354 can also be substantially uniform across its width. When thermoformed, the outer layer 3354 can maintain its predetermined shape without assistance from the inner layer 3352. That is, the outer layer 3354 can maintain its predetermined shape without tension, force, or support from the inner layer 3352.

[0475] Steering Figure 4R , the patient interface 6000 can include a vent formed in the tube 3350 (e.g., in the outer layer 3354) to vent exhaust gas to the atmosphere. In the example shown, the vent 6100 is formed adjacent to the cushion assembly 3150. Additionally, the air delivery tube 6348 can have a fabric construction. For example, the air delivery tube 6348 can have a construction similar or identical to any of the tube embodiments disclosed herein.

[0476] See also Figure 4S , the patient interface 7000 includes a positioning and stabilizing structure 7300. The positioning and stabilizing structure 7300 includes a tube 7350 having a left arm 7302 and a right arm 7304. The left arm and the right arm can be separate structures having connectors at their upper and lower ends so that these arms can be individually removably connected to both the cushion assembly 3150 and the sleeve 7200. For example, an upper connector 7312 and a lower connector 7314 are provided at the upper and lower ends of the left and right arms 7302, 7304, respectively. Figure 4T and 4U The upper connectors 7312 are configured for removable connection to the bushing, while the lower connectors 7314 are configured for removable connection to the cushion assembly 3150.

[0477] See also Figure 4T and 4U, each of the upper and lower connectors 7312, 7314 in these examples can include a connector body 7303, a slot 7309, a chamfered edge 7308, and a notch 7306 that can be removably connected to clips in the pad assembly 3150 and the bushing 7200 in a snap-fit ​​manner. In an alternative example, the connectors 7312, 7314 can be provided in the pad assembly 3150 and / or the bushing 7200 and the receiving portions can be provided on the left and right arms 7302, 7304.

[0478] like Figure 4S As shown, elbow 7220 is rotatably connected to bushing 7200 and includes a swivel connector at its opposite end for connection to an air delivery supply tube.

[0479] Steering Figure 4V , an illustration of a cross-section of the tube 7350 is shown. Similar to the outer layer 3354, the outer layer 7354 can be constructed so that it can support its own weight. As can be seen, the outer layer 7354 includes an outer covering layer 7402, which forms the outer surface of the outer layer that is positioned away from the patient's face during use. An outer cushioning layer 7406 (e.g., a foam material) is positioned between the outer covering layer 7402 and the fabric member 7410, which forms an airtight surface for the air passage. The outer cushioning layer 7406 can be thermoformed to maintain its shape. Adhesive layers 7404, 7408 can be provided between the outer covering layer 7402 and the outer cushioning layer 7406 and between the outer cushioning layer 7406 and the fabric membrane 7410, respectively. In Figure 4W In the optional example shown, outer buffer layer 7406 and adhesive layer 7408 can be removed.

[0480] Return to Figure 4V The inner layer 7352 includes a fabric sheet 7222 configured to engage the patient's face during use. An inner cushioning layer 7426 (e.g., a foam material) is disposed between the fabric sheet 7222 and the fabric member 7230 that forms the airtight surface of the air passageway. Adhesive layers 7224 and 7228 may be disposed between the fabric sheet 7222 and the inner cushioning layer 7226 and between the inner cushioning layer 7226 and the fabric membrane 7230, respectively.

[0481] Steering Figure 4X, the patient interface 8000 includes a positioning and stabilizing structure 8300 having a tube 8350. The left arm 8302 and the right arm 8304 can each have a lower portion 8362 and an upper portion 8364 of different stiffness. For example, the lower portion 8362 can be more rigid than the upper portion 8364, or vice versa. This can be achieved, for example, by configuring the inner layer 3352 of the lower portion 8362 to have a different stiffness than the inner layer 3352 of the upper portion 8364 and / or configuring the outer layer 3354 of the lower portion 8362 to have a different stiffness than the outer layer 3354 of the upper portion 8364. Note that each of the left and right arms can have three sections with different properties (e.g., stiffness) rather than just a lower portion and an upper portion.

[0482] In the example shown, the inner layer 3352 and outer layer 3354 of the lower portion 8362 are more rigid than the inner layer 3352 and outer layer 3354 of the upper portion 8364, respectively. As such, the upper portion 8364 is more flexible and can better conform to the curvature along the sides of the patient's face and up to the top of the patient's head. Tabs 3346 may be provided on the lower portion 8362, which may allow for a better connection to the strap 3420, as the increased rigidity of the lower portion helps resist torsion and maintain the desired application of vector force. Alternatively, tabs 3346 may be provided on the upper portion 8364 or bridge the upper and lower portions 8364, 8362.

[0483] In some embodiments, the cross-sectional shape of the tube can be specifically formed. For example, in some embodiments, the tube can be preformed to have a flat or planar contact surface and a convex outer layer. The shape of the conduit can be formed into a specific shape to provide a specific tactile feel and to regulate the amount or quantity of oxygen or air that is pressed toward the patient through the tube 3350. That is, the conduit can be formed to limit the extent to which the conduit stretches or expands when subjected to air or an oxygen source. In addition, the cross-sectional shape of the tube 3350 can vary along the length of the tube 3350. For example, the cross-sectional shape of the tube 3350 can be different near the connection port 3600 compared to the adjacent cushion assembly 3150. The cross-sectional shape and volume encompassed by the specific shape can be varied or changed depending on how the patient interface 3000 is configured to interact with the patient. For example, the end of the left arm 3302 can have a smaller cross-section than the connection point of the left arm 3302 and the connection port 3600. Because the end of the left arm 3302 is more likely to be associated with sensitive parts of the patient's face, limiting the cross-sectional size of the end of the left arm 3302 can increase patient comfort compared to other forms of the present technology.

[0484] In addition, changing the width of the inner or outer layer can allow the size of the chamber to be changed or diversified. For example, the portion of the inner layer 3352 that forms part of the air passage 3372 can have a width W1 at a first position of the left arm 3302, such as Figure 4C and Figure 4GWhen connected together, the inner layer 3352 and the outer layer 3354 form a cavity or chamber associated with the air passage 3372, having a cross-sectional area and a volume V1. Figure 4H As shown, inner layer 3352 and outer layer 3354 may also have a width W2 spaced apart from width W1 along left arm 3302. Width W2 may be greater than width W1. Furthermore, as shown, the cavity formed in region W2 has a volume V2 that is greater than volume V1. Therefore, when breathable air passes through the region of width W2, the cross-sectional area of ​​tube 3350 at the location of width W2 is greater than the cross-sectional area of ​​tube 3350 at the location of width W1. Furthermore, at the location having the second width W2, the volume of the chamber may be greater than at the first width.

[0485] The width can be varied to provide various properties or functions. In some forms, varying the volume of air or oxygen within a specific point can be used to alter the flow rate through various portions of the fabric duct. For example, if the fabric duct has a large cross-sectional area at a first location, breathable air passing through the fabric duct may flow at a first velocity. If the fabric duct has a smaller cross-sectional area at a second location, breathable air passing through the fabric duct at the second location may flow at a second velocity greater than the first velocity. Thus, the duct volume size can be varied to speed up or slow down the flow of air through the duct.

[0486] In some forms, the lumen size of a fabric conduit can be varied by changing the shape of the fabric layers and / or changing the width of the connections or joints of the fabric tube or conduit. A joint is an area where one layer of tubing is connected to another layer of tubing, or in some forms, where one layer is attached to itself when the tubing is formed from a single layer. For example, Figure 4G As shown, joint 3312 is where a layer, such as inner layer 3352, connects to lower layer 3354. Changing the width of joint 3312 changes the size of the chamber formed within the fabric conduit. For example, a wider joint reduces the chamber volume compared to a narrower joint. The width of the joint can be different on either side of the fabric conduit. Furthermore, the width of the joint can also vary along the length of the fabric conduit.

[0487] Varying the width of the joint 3312 can allow the stiffness of the fabric conduit to be varied along its length. For example, in locations that may be subject to higher stresses or a greater likelihood of bending, the width of the joint can be greater than the width in areas that do not have the same likelihood of bending. The width of the joint 3312 can depend on the width of the welding mechanism or cutting mechanism used to form the tube 3350. In other forms, a separate heating mechanism can also be used to connect the layers together. In this case, the heating mechanism can be moved to form a wider or narrower joint 3312. Although shown along the outside of the tube 3350, in some forms, the tube 3350 can be flipped inward to the outside so that the joint is located inside the chamber of the tube 3350.

[0488] In some forms, the position of the joint 3312 around the D-shaped cross-section of the tube 3350 can be varied to adjust the flexibility and stiffness of the tube along its length.

[0489] In some forms, the joints can be formed using various techniques that impart specific properties to the joints. For example, in some forms, ultrasonic welding, radio frequency welding, and cutting and welding techniques are used to form the joints. Heat can be applied in specific areas of the thermosetting or thermoplastic material used in the activated tube 3350. Heat can be used not only to connect the layers together, but also to thermoform the layers, such as the outer layer 3354. In addition, in some forms, stitching or adhesives such as glue can be used to connect the layers together. In some forms, stitching is not used. In further forms, materials located outside the layers are not used to connect the inner and outer layers of the tube 3350. For example, in some forms, the inner and outer layers can be formed so that no additional materials such as glue or stitching are required to connect the inner and outer layers together.

[0490] In some forms, a sleeve (e.g., constructed of fabric) may cover the tube 3350 to replicate the impression of bedding.

[0491] 5.3.3.1.1.2 Patient interface shape

[0492] The tube 3350 may also have various curvatures along its length to correspond to the shape of the patient's face. As previously discussed, the cross-section of the tube 3350 may have a particular shape. The shape of the tube 3350 may vary along its length (not just its width, as in FIG. Figure 4F). For example, the inner surface 3358 of the inner layer 3352 can have a generally positive curvature along the length of the inner layer 3352. A curvature can be included in the tube 3350 to correspond to a generally negative curvature of the patient's face along the area where the tube 3350 contacts the patient's head. It will be appreciated that the curvature of the patient's face is complex and varies, however, in general, at the point where the tube 3350 contacts the patient's head, the head is generally negatively curved. Furthermore, the curvature can be achieved even when the user is not wearing the headband 3300. That is, the curvature of the length of the tube 3350 can correspond to a predetermined non-planar configuration.

[0493] refer to Figures 4L-1 to 4L-4 , tube 3350 is shown separately. As shown, tube 3350 is bent or formed in three dimensions so that inner layer 3352 and outer layer 3354 are positioned around various planes. For example, outermost portion 3378 of outer layer 3354, adjacent to connection port 3600, extends along the XY plane. Conversely, outermost portion 3380 of outer layer 3354 of right arm 3304 is positioned along the YZ plane. Furthermore, in some embodiments, tube 3350 may include additional bends so that right arm 3304 is rotated along the Z axis so that a portion of outermost portion 3380 extends along the XZ plane. In this manner, tube 3350 may have a three-dimensional predetermined shape.

[0494] exist Figures 4L-2 to 4L-4 Detailed views of various portions of tube 3350 are depicted in FIG. Specifically, Figure 4L-2 A side view of a portion of tube 3350 is depicted. Figure 4L-3 This is a front view of a portion of tube 3350. Figure 4L-4 is a top view of a portion of tube 3350.

[0495] Based on the geometry of the tube 3350, the tube 3350 can be stiffer in certain areas. Figure 4L-1 As shown, bending or twisting the tube 3350 about various axes may require different levels of force. That is, the tube 3350 may resist deformation or bending along a plane or axis to a greater extent in a first region than in a second region. For example, twisting or bending the tube 3350 along the XY plane may require a different level of force at the first region 3308 adjacent to the connection port 3600 than at the second region 3310 of the right arm 3304. By arranging the tube 3350 in a particular orientation, the strength of the cross-sectional shape of the tube 3350 can be used to resist bending in that particular direction, thereby helping to provide a secure patient interface 3000.

[0496] In addition, if Figure 4L-1The illustrated tube 3350 can be curved or oriented at different angles. For example, the left arm 3302 and the right arm 3304 can be oriented closer to each other than depicted. That is, the spacing between the left arm 3302 and the right arm 3304 along the X-axis can be smaller. The spacing between the arms can be modified during the tube 3350 manufacturing process based on the desired specific shape. Furthermore, in some embodiments, the shape of the tube 3350 can be configured to align with or conform to the patient's face. The tube 3350 can have a shape that complements the patient's face. For example, a portion of the patient's face may have a negative curvature. The outer surface 3374 of the inner layer 3352 can be configured to have an opposite positive curvature, so that the inner layer 3352 rests flush against the user's face. Alternatively, in other areas of the patient's face, the outer surface 3374 of the inner layer 3352 can be configured to have an opposite negative curvature, so that the inner layer 3352 rests against the user's face. The tube 3350 can be formed with an inward curve at the arms, so that the tube 3350 provides compression to the user's face. That is, in some forms, the left arm 3302 and the right arm 3304 can be oriented at an angle relative to these planes. The left arm 3302 can lie in a plane that, if extended, intersects the plane in which the right arm 3304 lies. The orientation can provide compression against the user's head to help provide a comfortable and form-fitting placement.

[0497] In some forms, the left arm 3302 and the right arm 3304 can have accordion-shaped portions to increase the flexibility of the left and right arms, thereby allowing the arms to bend to conform to the patient's face.

[0498] In some versions, the tube shape can be specifically formed. The top view of the catheter can vary. Unlike silicone tubing, fabric tubing can be cut and formed to create a specific shape, rather than being formed entirely through molding, such as injection molding. This ability to determine a specific shape without complex molds can reduce manufacturing costs compared to other versions.

[0499] In some forms, the layers may be knitted in a particular manner so that the layers are knitted into shape. In other forms, a woven, nonwoven, or other fabric of a web may be cut into shape. In some forms, an L-shaped conduit may be formed. In other forms, for example, Figure 4E As shown, a U-shaped tube 3350 can be formed. By forming the air delivery system from a fabric material, various other shapes and configurations can be formed. In addition, working with flat or planar sheets can facilitate manufacturing and assembly. Because the material can be processed in two dimensions, the complexity of joints, connectors, or bends is reduced. Although shown for ease of viewing, Figure 4E is shown in two dimensions, but in other forms, such as Figures 4A-4DAs shown in FIG, the tube 3350 can also be bent or twisted during manufacturing so that the tube 3350 has a predetermined three-dimensional shape.

[0500] In some forms, multiple layers can be combined to form a tube. By forming the tube from multiple separate sheets, complex designs and specific shapes can be easily created compared to other forms. For example, rather than forming a three-dimensional tube, the shape can simply be cut from two-dimensional layers. The layers can then undergo additional processing to form the three-dimensional shape. By initially forming or designing the shape in two dimensions, processing can be simpler, less time-consuming, and more economical than with other forms.

[0501] In addition to maintaining its shape in the absence of pressure or force, the patient interface 3000 can be configured to be elastically formed. The patient interface 3000 can be located within the packaging before the patient opens and uses the patient interface 3000. Some currently existing patient interfaces are difficult to orient for wearing on the patient's head. The straps of some interfaces are entangled with each other, making it unclear how to properly wear the patient interface. However, the patient interface 3000 is formed so that when removed from the packaging or luggage or any limited space, the patient interface 3000 will spring into its predetermined shape. That is, without additional effort from the user, the patient interface 3000 will orient the arms of the patient interface 3000 so that it is obvious to the patient how the patient interface 3000 is to be worn, without the need for additional undoing or arranging of the components of the patient interface 3000. This configuration can allow the patient to easily utilize the patient interface 3000.

[0502] 5.3.3.1.1.3 Structural supports

[0503] In some forms, the joint can serve as a seal for the tube 3350 as well as a stiffener or support structure for the tube 3350. The arm supports 3314 are wider joints that can be used to specifically direct force vectors and provide a seal between the seal-forming structure 3100 and the patient's airway. The arm supports 3314 can resist bending so that sufficient force is provided rearwardly and upwardly through the tube 3350 to the cushion assembly 3150 to provide a seal between the seal-forming structure 3100 and the patient's airway. Figures 4A-4DThe stabilizing structure 3300 includes an arm support 3314. As shown, the arm support 3314 extends along a portion of the left arm 3302. An arm support may also be included along a portion of the right arm 3304. The arm support 3314 resists bending of the left arm 3302, ensuring that the seal-forming structure 3100 remains properly positioned relative to the user's face or nose when the patient interface 3000 is worn. For example, when worn, the headband 3300 may tend to straighten between the patient's supra-auricular base and the patient's airway. That is, the headband 3300 may tend to straighten where the tube 3350 bends toward the cushion assembly 3150. The arm support 3314 prevents the left arm 3302 from rotating about the X-axis. As shown, the arm support 3314 is formed from an inner layer 3352 and an outer layer 3354. That is, no additional materials or components are used in the arm support 3314, so that the arm support 3314 is formed solely from the materials and layers used to form the tube 3350. In this way, the stabilizing structure 3300 can be formed in an efficient manner without requiring additional components. Furthermore, separate stiffeners beyond the inner layer 3352 and outer layer 3354 can be included in various portions of the tube 3350, such as within or along the outer surface of the arm support 3314. In other forms of the present technology, separate stiffeners are used to provide rigidity to the tube 3350. A rigidifying element according to one form of the present technology is preferably thin and conformable when the patient lies on it, but possesses sufficient stiffness to resist out-of-plane bending. That is, the rigidifying element is configured to allow bending in some planes and resist bending in others, for example, to allow bending toward and away from the patient's face. The rigidifying element also renders the tube 3350 inextensible or instretchable in the area where the rigidifying element is used, allowing the tube 3350 to be tensile and maintain its dimensions. The rigidifying element can be located within the airflow path of the tube 3350 or can be located externally to the tube 3350.

[0504] Furthermore, a reinforcer may correspond to a component having a greater hardness and / or stiffness than the surrounding material. Additionally, a reinforcer is utilized to resist deformation of the finger. Furthermore, a reinforcer may refer to a component other than the layers forming the inner layer 3352 and the outer layer 3354. For example, a specific area of ​​the tube 3350 may include additional components other than the material used to form the inner layer 3352 and the outer layer 3354. In some forms, the connection port 3600 (see Figure 4M and 4N ) can be considered a stiffener. The connection port 3600 can be formed of a material that is harder than the surrounding material, and the connection portion 3600 can resist finger deformation. In other forms, the stiffener can refer to a material that is permanently attached to the inner layer 3352 or the outer layer 3354 in addition to the inner layer 3352 and the outer layer 3354. In addition, the stiffener can increase the stiffness of the layer in contact with the stiffener compared to the material layer without the stiffener.

[0505] In one form, the rigidifying element can provide structural integrity or a self-retaining form to the patient interface so that the patient interface can maintain its shape and not bunch up, e.g., shape memory, whether the patient interface is on or off the patient's head. The shape-retaining arrangement maintains the tubes in a desired position and can facilitate donning of the patient interface during use.

[0506] In some embodiments, rigidifying elements may be used in specific locations. For example, rigidifying elements may be used between layers of the stabilizing structure 3300. For example, the rigidifying elements may be located between the inner layer 3352 and the outer layer 3354. In other embodiments, the rigidifying elements may be located between the various sheets forming the inner layer 3352 and the outer layer 3354. In other embodiments, the rigidifying elements may be positioned along the inner or outer surface of the stabilizing structure 3300. In other embodiments, the rigidifying elements may be located in high stress areas, such as when the head strap 3420 interacts with the tube 3350. The rigidifying elements may be used to provide rigidity to the overall shape of the patient interface 3000, as well as to provide support to the cross-section of the tube 3350, thereby resisting collapse of the tube 3350.

[0507] In some embodiments, a rigidizing element may be positioned along an outer surface of the headband 3300. For example, a rigidizing element may be positioned along outer surface 3376 of the outer layer 3354 at the location of the arm support 3314. In some embodiments, there is no stiffener within the cavity of the tube 3350 between the connection port 3600 and the assembly connection ports 3154 and 3155. In other embodiments, there is no stiffener between the connection port 3600 and the assembly connection ports 3154 and 3155, or between the joints of the inner layer 3352 and the outer layer 3354. In further embodiments, there is no stiffener contacting the inner layer 3352 between the connection port 3600 and the assembly connection ports 3154 and 3155.

[0508] In other embodiments, the structure and orientation of the inner layer 3352 can allow bending in some directions while having sufficient stiffness to resist bending in other directions. That is, the inner layer 3352 can be configured to allow bending in some planes and resist bending in others, for example, allowing bending toward and away from the patient's face to conform to the patient's head while resisting bending along a plane extending along the inner layer 3352. Thus, a first plane in which the inner layer 3352 is configured to bend can be perpendicular to a second plane in which the inner layer 3352 resists bending. The outer layer 3354 can also allow bending and resist bending, similar to the inner layer 3352.

[0509] As described above, the joint 3312 can form a stiffener. The joint 3312 can be configured such that the tube 3350 allows bending in some planes and resists bending in other planes, for example, allowing bending toward and away from the patient's face in a first plane to conform to the patient's head and resisting bending along a second plane in which the inner layer 3352 extends. Furthermore, the joint 3312 can be configured to be substantially rigid so as to resist bending in the first and / or second planes.

[0510] In other embodiments, the size of the conduit can help resist bending. For example, in some embodiments, the conduit can have a smaller cross-section in a first region. In the first region, such as a region having width W1, there is a greater material density when compared to the volume or space that the first region may contain. By increasing the material density at a given location, the strength or stiffness perpendicular to the outer layer 3354 or resistance to bending or deformation in a specific region can be increased compared to other regions. Specific regions that may withstand increased forces (such as bending or kinking) can be specifically shaped so that a specific material is used to resist bending or kinking. For example, as shown, the tube 3350 is narrower at endpoint 3306. Endpoint 3306 can connect to the cushion assembly 3150. Areas of the mask are more likely to be exposed to bending and kinking. Therefore, by varying the material density at the mask connection location, the likelihood of kinking and bending within the tube 3350 can be reduced.

[0511] 5.3.3.1.1.4 Pipe layer properties

[0512] In some embodiments, the inner layer 3352 and the outer layer 3354 are formed from different materials. In some embodiments, the inner layer 3352 may be formed from a softer or more gentle fabric material than the outer layer 3354. Because the inner layer 3352 is exposed to the patient's skin, the material of the inner layer 3352 may be formed to be particularly comfortable against the patient's skin. The outer layer 3354 may be made of a different material than the inner layer. The outer layer 3354 is more likely to get caught in abrasive materials or rub against objects. Therefore, in some embodiments, the outer layer 3354 is formed from a durable material that may not be as soft as the inner layer. In addition, the outer surface 3376 of the outer layer 3354 and the outer surface 3374 of the inner layer 3352 may have different surface properties than the inner surfaces of the corresponding layers. In addition, the outer surface 3374 may have a higher coefficient of friction than the outer surface 3376 of the outer layer 3354 to maintain the positioning of the patient's face and the position of the stabilizing structure.

[0513] In some versions, specific surfaces can be layered with a membrane. For example, in some versions, only the interior of the catheter or sealing structure includes a membrane. Thus, the outer and inner surfaces can have different properties. The outer surface can be softer and breathable and can be formed from cotton. This surface can be more comfortable or pleasing to the patient than silicone or polyurethane surfaces. However, the inner surface can be layered or coated with a membrane. Thus, the membrane surface can be separated or isolated from the patient's skin. By having different material properties on the inner or outer surface of a fabric catheter, the comfort of a specific component can be improved.

[0514] Alternatively, outer surface 3376 may comprise only a fabric surface. That is, outer surface 3376 may not be covered or laminated with a fabric membrane. In some embodiments, depending on the design of the particular tube, the outer surface of a particular sheet may or may not be laminated with a fabric membrane. For example, outer surface 3374 of inner layer 3352 may not be covered or lined with a fabric membrane to provide a comfortable surface for the patient. However, outer surface 3376 of outer layer 3354 may include a membrane for added protection or resistance to abrasion or other external forces. Furthermore, because outer layer 3354 is spaced from the patient's skin, it may not be necessary to form outer layer 3354 with different surface properties along inner surface 3356 and outer surface 3376. For example, outer layer 3354 may be dipped in a thermoplastic or thermoset material so that both surfaces are covered with a fabric membrane. In this configuration, the manufacturing cost of outer layer 3354 can be reduced because the time required to dip outer layer 3354 can be less than the time required to laminate the surface of the layer.

[0515] The total weight of the positioning and stabilizing structure is preferably less than 50 g (eg, less than 40 g or less than 30 g). Each of the inner layer 3352 and the outer layer 3354 may have a thickness of less than 2 mm (eg, less than 1 mm).

[0516] By using fabric sheets, colors can be easily customized. For example, one sheet can be blue, while another can be white. Different colors can allow consumers to select specific combinations, which can increase the likelihood that patients will continue to use the device for treatment.

[0517] By forming the headband, tube or conduit in this manner, the headband can be specifically formed to adjust or conform to the contours of the patient's face. The shape of the fabric conduit can be determined by how the inner and outer layers are cut and attached to each other, rather than by a straight cylindrical tube.

[0518] 5.3.3.1.1.5 Patient interface during use

[0519] like Figures 4B-4DThe patient interface 3000 shown can be worn on the patient's head. Once in place, pressurized air is supplied through air delivery tube 3348. From air delivery tube 3348, pressurized air passes through left arm 3302, right arm 3304, or both arms. The air then passes through the assembly connection port or ports 3154 and 3155 and into cushion assembly 3150. In this manner, air is supplied to the patient.

[0520] In some forms, the cross-section of tube 3350 may change or vary as pressurized air passes through tube 3350. Figure 4F 、 4G As shown in FIG4H , the inner layer 3352 is substantially planar. In some embodiments, during use, the inner layer 3352 can bulge or bend away from the outer layer 3354 between the joints 3312. That is, the inner surface 3358 of the inner layer 3352 can have a positive curvature. In other words, the outer surface 3374 of the inner layer 3352 can have a negative curvature between the joints 3312. The curvature can help separate the rest of the inner layer 3352 from the patient's face or head. For example, the curvature can separate the joints from the patient's face and increase patient comfort.

[0521] In some embodiments, the outer layer 3354 can also expand when subjected to pressurized air during use of the patient interface 3000. Although the outer layer 3354 is formed in a predetermined shape, the outer layer 3354 is not a rigid structure and can expand when exposed to pressurized air. This expansion can be in the material itself (e.g., the outer layer 3354 can stretch) or can be caused by the edges of the tube 3350 moving toward each other. For example, the joints 3312 can move toward each other so that the curvature of the inner surface 3356 of the outer layer 3354 becomes more positive than when in an unpressurized state. During use, the change in shape can be adjusted to the patient's particular comfort and tactile properties.

[0522] Additionally, as before, the permeability of the tube 3350 can be adjusted in specific areas. In one area, the tube 3350 can be completely impermeable to air, while in another area a specific amount of air can be allowed to pass through the tube 3350. For example, in some forms, the permeability of the tube 3350 can be adjusted to allow a specific amount of air to pass from the tube 3350 to the patient's cheek. Additionally, the tube 3350 can be adjusted so that air is only allowed to move through one layer of the tube 3350 (i.e., toward the patient through the inner layer 3352 or away from the patient through the outer layer 3354).

[0523] The fabric structure of tube 3350 allows for a positioning and stabilizing structure that is less resonant than conventional air delivery tubes and catheters, which is less intrusive to the patient and thereby facilitates compliance with therapy.

[0524] 5.3.3.1.1.6 Headband Positioning

[0525] In some forms of the technology, the stabilizing structure 3300 includes a mechanism for connecting the headgear straps to the seal-forming structure 3100. The headgear straps may be connected directly or indirectly to the seal-forming structure 3100. For example, Figure 4C As shown, a tab 3346 configured to connect to the head strap 3420 protrudes outward from the tube 3350 in a generally rearward direction. The tab 3346 may have a hole or slot therein to receive the end of the head strap 3420. However, as shown, the strap 3420 may be secured between the inner layer 3352 and the outer layer 3354. That is, the strap 3420 may be secured without any additional material other than the material of the inner layer 3352 and the outer layer 3354. For example, the strap 3420 may be secured using a thermosetting or thermoplastic material of the inner layer 3352 and the outer layer 3354. Furthermore, the strap 3420 may extend into the cavity of the tube 3350 and may be located outside the tube 3350. In other embodiments, the strap 3420 may be in the form of a string or cord or other tubular structure that passes through an opening in the tab 3346.

[0526] In some forms of the present technology, the rear strap 3420 is adjustable. In some forms, the strap 3420 may include hook-and-loop fasteners, allowing a portion of the rear strap 3420 to be passed through a hole in the tab 3346 and secured to itself. In some forms of the technology, the angle of the strap 3420 relative to the tube 3350 or the patient's head can be adjusted to fit at different locations around the patient's head. This adjustability helps the headband 3300 accommodate different head shapes and sizes.

[0527] In some forms of the technology, the strap 3420 exerts a force on the tube 3350 to pull the tube in an at least partially rearward (e.g., rearward) direction at the location of the tabs 3346. The strap 3420 can also exert a force on the tube 3350 to pull the tube in an at least partially downward (e.g., downward) direction. The amount of force can be adjusted by varying the length of the strap 3420 between the tabs 3346.

[0528] In some forms of technology, e.g. Figure 4C In the form shown, the direction of the force applied by the strap 3420 to the tube 3350 can also be changed. The direction can be changed by adjusting the angle of the strap 3420 relative to the tube 3350 or the patient's head. In some forms of the technology, the location at which the strap 3420 applies the force on the tube 3350 can be changed by adjusting the location at which the strap 3420 is secured to the tube 3350.

[0529] In some forms of technology, when worn by a patient, the seal-forming structure 3100 tends to fall off the patient or from the front, as well as downward or from the bottom. The headband 3300 is arranged to counteract or resist these tendencies. The tube 3350, together with the strap 3420, provides an upward and rearward force, so that the seal-forming structure 3100 remains in place during use. In addition, the tube 3350, together with the strap 3420, provides additional rearward and upward force, so that the sealing layer 3102 provides a seal against the patient's airway. The headband 3300 receives a downward force from the seal-forming structure 3100, which is at least partially offset by the arm supports 3314. In addition, the top of the tube 3350 allows the headband 3300 to remain in place in the upward / downward direction, while the strap 3420 helps maintain the position of the headband 3300 in the forward / backward direction.

[0530] The direction and magnitude of the force required for a secure fit and effective seal may vary between patients based on the position of the stabilizing structure 3300 on the head, which may vary due to, for example, differences in head shape and size. In some forms of the technology, the adjustability of the strap 3420 can balance the force across a range of head shapes and sizes to keep the headband 3300 in a comfortable position while maintaining an effective seal.

[0531] 5.3.3.1.1.7 Connection Port Configuration

[0532] Tube 3350 includes a plurality of connecting components configured to transfer air into and out of tube 3350. These connecting components are integrated into tube 3350 to provide a seamless or smooth transition and connection to other components of the treatment device. These connecting components can be formed of a different material than tube 3350. In some embodiments, these connecting components are a hard or rigid plastic that resists bending or compression. Such a material can be used to reduce the possibility of air being trapped by the connecting components.

[0533] refer to Figure 4M and 4N , depicting connection port 3600. As shown, connection port 3600 includes an upper surface 3602 and an opposing lower surface 3604. A channel 3606 extends between upper and lower surfaces 3602, 3604 to direct air from inlet 3608 to either side of tube 3350. Air is directed into and through inlet 3608, through upper surface 3602, and into channel 3606. The air is then directed along tube 3350 to the patient's mouth and / or nose.

[0534] See Figure 4M, the connection port 3600 is depicted as being within a portion of the tube 3350. In some forms, the connection port 3600 may not be sealed or connected to the layers of the tube 3350. That is, the connection port 3600 is able to slide along the inner surface of the layers of the tube 3350. Rather than being sealed or mechanically connected to the layers of the tube 3350, the connection port 3600 may be restricted from lateral movement by the shape of the tube 3350. For example, the width of the tube 3350 may be tapered or reduced so that the connection port 3600 cannot slide to a significant extent.

[0535] refer to Figure 4O , depicts an optional form of the present technology of a connection port. As shown, the connection port 3701 includes an outer portion 3702 and an inner portion 3704. The inner portion 3704 can be inserted into the tube 3350 so that the inner portion 3704 is located between the inner layer 3352 and the outer layer 3354. The outer portion 3702 includes an extension that interacts with the inner portion 3704. The outer portion 3702 is positioned around the opening in the tube 3350 and aligned with the inner portion 3704. The outer portion 3702 can be snapped into the inner portion 3704 or otherwise secured to the inner portion 3704. In this way, the outer layer 3354 is secured between the inner portion 3704 and the outer portion 3702 of the connection port 3701. In addition, the inner portion 3704 can be equipped with a support to prevent the inner layer 3352 from abutting against the outer layer 3354 at the connection port. As shown, the inner portion 3704 includes a support 3706. The support member 3706 is a cage-like structure that allows air to flow through the opening of the connecting portion 3700 and reach the rest of the tube 3350 , while also providing a gap or space between the inner layer 3352 and the outer layer 3354 of the tube 3350 .

[0536] Additional connection components can connect the tube 3350 to the seal-forming structure 3100. As shown, there are two connection components attached to the tube 3350, which are connected on either side of the frame 3152 of the seal-forming structure 3100. The assembly connection port 3154 can be formed in a similar manner to the connection port 3600. In addition, the assembly connection port 3154 is configured to engage with an opening of the seal-forming structure 3100 so that the cushion assembly 3150 is fluidly connected to the tube 3350. By using more than one connection component, that is, by collapsing one side of the tube due to the weight of the patient's head when the patient is lying on their side, air will also be delivered to the patient.

[0537] 5.3.3.1.1.8 Method for manufacturing headband tube

[0538] The air delivery system of the stable structure 3300, such as the tube 3350, can be formed and manufactured using various techniques. In some forms, each of the layers or sheets of fabric used to form the tube 3350 can be pre-formed to have a specific cross-section. These layers or sheets can be coated with silicone, polyurethane, thermoplastics, thermosetting materials, or other conformable materials. The materials can be the same materials used to form the fabric membranes described above. In some forms, the layers can also serve as fabric membranes. After receiving the conformable material, these sheets or layers can then be placed in a mold. Next, the layers or sheets can be heated to melt the conformable material. The heat is then removed from the layers, causing the conformable material to solidify. The layers can then be removed from the mold, causing the layers to take on the shape of the mold.

[0539] Now refer to Figures 8A-8F , depicts an overview of one process for forming a tube or air delivery system. As shown, mold 3800 is formed into a generally concave shape. The shape of mold 3800 may be changed or modified depending on the desired shape of the tube to be produced. Fabric sheet 3360 may be a fabric sheet formed from the materials described above. In some forms, fabric sheet 3360 may already include a fabric membrane layer along the surface of fabric sheet 3360. However, in Figures 8A-8F In the form shown, the fabric sheet 3360 does not yet include a fabric membrane. The fabric sheet 3360 is then placed in a mold, such as Figure 8B After the fabric sheet 3360 is fully oriented, another sheet is placed on top of the fabric sheet 3360. Figure 8C and 8D As shown, the fabric membrane 3362 is oriented relative to the fabric sheet 3360. The fabric membrane 3362 can be a membrane formed from silicone, thermoplastic, or other materials as previously described with respect to textile membranes. Figure 8D In the illustrated step, the combination of fabric sheet 3360 and fabric film 3362 can be subjected to heat, causing the film to melt or partially melt and / or otherwise adhere to the surface of fabric sheet 3360. The combined fabric sheet 3360 and fabric film 3362 can then be removed from mold 3800 after fabric film 3362 has solidified. Once fabric film 3362 solidifies, fabric film 3362 can assume the shape of mold 3800, and thus fabric sheet 3360 can assume the shape of mold 3800, thereby forming the aforementioned inner layer 3352. Note that one or both of inner layer 3352 and outer layer 3354 can be thermoformed into a predetermined shape. In other examples, neither inner layer 3352 nor outer layer 3354 is thermoformed.

[0540] In some forms, a combination of multiple formed sheets and films may be used to form a tube or portion of an air delivery system. Figure 8E and 8FAs shown, the inner layer 3352 and the outer layer 3354 are both thermoformed and can be combined to form the tube 3350. The tube 3350 can have a stable shape including a specific volume for receiving pressurized air. In addition, the tube 3350 can be folded and can be easily collapsed for storage. Because the tube 3350 includes the fabric membrane 3362, the tube 3350 can be restored to its original shape even after being folded or stored. Figure 8F 3800. Furthermore, additional or different layers may be used to form a more or less rigid structure. For example, outer layer 3354 may be formed to include a thermosetting material, such as a foam layer, that, when heated, takes the form of mold 3800. Additional layers, such as fabric sheets, foam layers, fabric films, or other layers may be used to provide sufficient shape-retaining features or provide sufficient stiffness or hardness to tube 3350 so that tube 3350 maintains its shape.

[0541] In other embodiments, a mandrel may be used. Instead of using a negative mold such as mold 3800, the mandrel may be covered with various layers such as inner layer 3352. Once covered with the desired layers, the mandrel may be heated or the layers may be heated to activate the thermoplastic or thermosetting material. The mandrel may then be removed, thereby forming inner layer 3352 or other layers of a specific mandrel shape.

[0542] In another form of the present technology, the film or conformable layer can be a liquid or paste. In a further form, the conformable layer may not require thermal curing. For example, when exposed to air, the conformable layer can cure in a manner similar to a glue adhesive. In a further form, a chemical reaction can be used, such as epoxy resin or fiberglass resin. In some cases, the molding process may limit the shape and design of a particular component. Therefore, in some forms, a layup method can be used to form various components. The layup includes a mold of a specific shape. A layer, such as a textile or fabric layer, can be placed into the mold. A resin, film material or other material is then placed on the layer. The resin or other conformable material is then cured so that the shape of the layer corresponds to the shape of the mold. In some forms, a release agent can be placed between the textile layer and the mold to help provide easier removal of the layer from the mold. Once removed from the mold, the layer can maintain or retain the shape of the mold.

[0543] like Figures 8G-8K As shown, tube 3363 can be formed using the techniques described above. Figure 8G As shown, the fabric sheet 3360 is placed in the mold 3800. Figure 8H In this embodiment, the fabric film 3362 is placed along the fabric sheet 3360. In this embodiment, the fabric film 3362 can be applied in liquid form. Figure 8C The method described in is the opposite. Figure 8IAs shown, the fabric film 3362 is unfolded along the fabric sheet 3360 so that all appropriate portions of the fabric sheet 3360 are covered by the fabric film 3362. After the fabric film 3362 is cured by heating or other means, the inner layer 3352 including the fabric sheet 3360 and the cured fabric film 3362 is removed from the mold 3800. Figures 8A-8F In a manner similar to the tube 3350 shown, the inner layer 3352 can be combined with the outer layer 3354 to form the tube 3350.

[0544] After forming the two layers (e.g., inner layer 3352 and outer layer 3354), they can be connected along the longitudinal edges to form the chamber. In some forms, the two layers can be connected using glue or other adhesives. In other forms, the layers can be connected using mechanical fasteners such as nails, screws, or buttons. In other forms, the two layers can be stitched or sewn together. In further forms, the two layers can be welded together. In terms of welding, high frequency welding or radio frequency welding can be used to weld the two layers. In further forms, a hot cutter can be used to cut the layers, and when cutting, a seal can also be formed between the two layers when the parts of the two layers melt and solidify, thereby forming a seal between the first layer and the second layer.

[0545] In some forms, welded connections can be used at different locations on the fabric conduit. In some forms, welded connections can be used to connect other components to the fabric conduit or to connect the fabric conduit to other components. Components can be secured to each other using various types of welds, rather than relying on physical fasteners such as threads, clips, snaps, etc. By using welds, bulky connections can be reduced. Furthermore, by utilizing welded connection techniques, no additional connecting components may be required. For example, a connection between a fabric tube and an adapter or connector can be formed by placing a portion of a layer of the fabric conduit around the adapter so that the membrane of the layer rests against the adapter. The combination of the layer and the adapter can then be subjected to heat so that the membrane melts or conforms to the adapter. When the membrane solidifies, a secure connection can be formed between the layer and the adapter.

[0546] Reference Figure 8L and 8M , the above techniques can be applied to more complex shapes. Molds and thermoplastic materials can also be used to form three-dimensional shapes along the length of the part, rather than using molds and thermoplastic or thermosetting materials to shape only the internal cross-section. That is, in addition to forming the cavity, the mold can be used so that the tube 3350 can be bent or rotated along three axes and maintain the shape without additional support. Figure 8LAs shown, the mold 3802 includes a groove or receiving portion 3804 extending in the first direction D1 and the perpendicular direction D2. The fabric sheet 3360 can be cut into a specific shape and then placed along the receiving portion 3804 of the mold 3802. For simplicity, the fabric sheet 3360 can be laminated with a thermosetting material or other conformable film. Figure 8M As shown, the fabric sheet 3360 is heated to melt the film or conform to the shape of the receiving portion 3804. Once solidified, the fabric sheet 3360 is removed from the mold 3802 and retains the shape of the receiving portion 3804.

[0547] Tube 3350 may be formed using a sheet molded in mold 3802 (see Figures 4L-1 to 4L-4 ). For example, a second sheet similar to fabric sheet 3360 may be formed with Figures 8A-8F As shown in the figure, the fabric sheet 3360 is formed and connected in a similar manner. Figures 4L-1 to 4L-4 As shown, the tube 3350 can be oriented in a variety of directions. That is, the tube 3350 can be formed into or adapted to return to a three-dimensional object. By forming the tube 3350 into a three-dimensional object, the amount or number of wrinkles or bends in the tube 3350 during use can be reduced. For example, rather than requiring the patient to bend or twist the tube 3350 to conform to the patient's face, the tube 3350 can be pre-formed with bends or turns. Kinks that could reduce airflow through the tube 3350 can be reduced by providing natural bends or turns within the shape of the tube 3350, as opposed to later forming the tube 3350 in a separate step. As Figures 4A-4D As shown, when a patient uses the tube 3350, the shape of the tube 3350 can correspond to the shape of the patient's face and head. In particular, by shaping the tube 3350 during the manufacturing process, pressure points can be reduced.

[0548] Additionally, in some forms, only a first sheet (e.g., fabric sheet 3360) is molded or formed within a mold, such as mold 3802. A sheet that has not been pre-molded may be attached to the molded sheet such that the second sheet conforms to the shape of fabric sheet 3360.

[0549] Fabric membranes can be positioned along different surfaces of a fabric. A fabric can be immersed in a material so that all sides are covered or laminated with the membrane. Other fabric forms may coat or laminate a single surface of the fabric. In some forms, a membrane or curing material may be positioned only along a single surface of the textile layer. That is, in some forms, a first surface of a textile material may be coated with another material, such as a thermoset, and a second surface may be uncovered textile. In other words, different properties can be present on either side of the material. Membranes can also be formed from a variety of materials. In some forms, the fabric membrane is formed from silicone, while in others, the membrane is formed from polyurethane. In other forms, different materials may also be used.

[0550] In some embodiments, the fabric membrane can be positioned along a flat or planar sheet of fabric. That is, a fabric sheet can be manufactured and include a layer of membrane material along the surface of the fabric. In some embodiments, the membrane can be laminated to the fabric in a sheet-like manner. In other embodiments, the membrane can be deployed around the fabric while in a liquid or semi-liquid form, such that the membrane covers the surface or a portion of the surface of the membrane. The membrane can then be cooled or dried, causing the membrane to solidify along the surface of the fabric.

[0551] In some forms, various methods and techniques may be utilized to form the various components of the therapeutic device. In some forms, flat or planar materials may be manipulated to form three-dimensional structures for use in the therapeutic device. These materials may be customized or adjusted to allow for greater comfort compared to other forms. In some forms, the seal-forming structure may be formed from a fabric material. Such a material may be less obtrusive, more comfortable, and lighter in weight than other configurations. Additionally, other components may also be formed from planar materials that are manipulated to form a three-dimensional structure. For example, a tube may be formed from a planar material. Furthermore, other components that contain or come into contact with pressurized air may also be formed from planar materials. In addition to components that include or direct pressurized air, other components such as straps may be formed from planar materials that are manipulated to form a three-dimensional structure.

[0552] Known patient interfaces also typically include a separate headband and air delivery component for positioning and providing breathable gas to a mask or the like. Known headbands typically include an assembly of elastic (or non-elastic) straps, buckles, locks, and / or clips. Known air delivery components typically include a spiral reinforced tube having a diameter of 15-22 mm and a swivel connector. For those who are less skilled and / or unfamiliar with the device, these known headband and air delivery component arrangements can be difficult to use. These known headband and air delivery component arrangements can also be uncomfortable or impractical.

[0553] 5.3.3.1.1.8.1 Cutting and sealing methods

[0554] Various methods and techniques can be used to form and connect components. In one form, multiple components can be formed using a cutting and sealing method. In this method, each component can be cut into a specific shape. In some forms, these components can then be stacked on top of each other after the cutting has occurred. In other forms, multiple layers can be stacked on top of each other, and then all layers can be cut at once. In some forms, these layers can also be connected to each other during the cutting process. For example, in some forms, a hot cutter can be used to cut and fuse the layers together. In this method, the time required to manufacture a particular component can be reduced compared to other manufacturing methods.

[0555] The sheets used to form fabric ducts can be smaller than 750 mm x 350 mm. In other versions, the sheets can be larger or smaller than 750 mm x 350 mm. The small size of the sheets can allow for the formation of multiple fabric ducts or tubes within a small footprint. By reducing the footprint of the elements used to form the fabric ducts, manufacturing costs can be reduced because less space needs to be rented or maintained.

[0556] refer to Figures 9A-9E , depicts a current form of the present technology such that a tube is formed using a cut and seal method. An outer covering layer 3366, a tube sheet 3364, and a fabric sheet 3360 are depicted. As shown, each sheet comprises a fabric membrane or other fusible film as in the forms previously described. As before, the outer covering layer 3366 can serve as an outer layer and therefore can have different material properties than the tube sheet 3364. The fabric sheet 3360 can be an inner layer and be formed of a material that is soft against the user's skin on the outer surface, while also including a fabric membrane configured to reduce the amount of air passing through the fabric sheet 3360. In some forms, the outer surface 3374 of the fabric sheet 3360 can be configured to rest against the patient's skin.

[0557] like Figure 9A and 9B As shown, the layers are stacked on top of each other. In some forms of the present technology, guides indicating the desired cutting locations can be placed on the layers. In some forms, the fabric sheet 3360 can be pre-stretched prior to assembly. For example, the fabric sheet 3360 can be stretched horizontally, vertically, or both horizontally and vertically to provide a specific configuration. After the upper and lower layers are connected, the tension can be released from the fabric sheet 3360 so that it assumes an unstretched position. This may cause the upper layer to bend when the fabric sheet 3360 is unstretched. Thus, a specific shape can be achieved by pre-stretching the lower layer during manufacturing and then releasing the tension.

[0558] exist Figure 9BIn some embodiments, laser 3382 is used to cut and seal various sheets of material. In some embodiments, welding techniques, such as high-frequency (HF) welding or radio-frequency (RF) welding, can also be used to form the seal. In other embodiments, a hot cutter can be used. As the material is cut, the thermoset, thermoplastic, or conformable film adjacent to the cut line may melt or change properties. The melting of the film allows the film to interact with adjacent layers. For example, the film of outer cover layer 3366 can interact with the upper surface of tube sheet 3364. Similarly, the film of tube sheet 3364 can interact with the lower surface of outer cover layer 3366. Furthermore, the film of tube sheet 3364 can interact with the inner surface of fabric sheet 3360. In other embodiments, tube sheet 3364 may include only the film along the lower surface, and outer cover layer 3366 may include a film that melts and interacts with the upper surface of tube sheet 3364. After the films have melted, they can solidify. Upon solidification, the sheets are connected to each other along the cut line. In this manner, for example, tube 3450 (see Figure 9C ). In contrast to tube 3350, tube 3450 may not have thermoformed inner and outer layers. Rather, outer layer 3354 and inner layer 3352 may be connected along the outer edges along a joint and not further subjected to heating to maintain a specific cross-sectional shape when not exposed to internal gas pressure or other forces.

[0559] In some forms, additional components may be incorporated into the fabric conduit during the process of forming the fabric conduit. For example, in some forms, connecting components may be incorporated into the fabric conduit during the manufacturing process. In some forms, an elbow or tube connector may be placed along the inner layer before the outer layer is secured to the inner layer. After the tube connector is placed along the inner layer, the outer layer is placed over the inner layer. Next, a connection is formed between the inner and outer layers. As before, the connection may be formed by various welding techniques. In some forms, the connection between the inner and outer layers may also secure the tube connector. However, in other forms, the tube connector may be trapped within the cavity of the conduit, however, the tube connector may not be physically secured to the inner or outer layer. That is, in some forms, the movement of the tube connector may be limited by friction or spatial constraints within the cavity. In other forms, the tube connector may be clamped in place, as previously described.

[0560] As shown, the connection port 3600 is arranged between the tube sheet 3364 and the fabric sheet 3360. In addition, the component connection ports 3154 and 3155 can also be positioned similarly. The connection port 3600 and the component connection ports 3154 and 3155 are sandwiched between the tube sheet 3364 and the fabric sheet 3360. Once Figure 9B As shown sealed, the connection port can be located within the tube 3450 without requiring another step to insert or position the connection portion within the tube.

[0561] Reference Figures 9C to 9E , tube 3450 is depicted in various states. Figure 9D As shown, tube 3450 is depicted as being in a stable state and not subject to internal air pressure. In this form, as shown in cross-section, outer layer 3354 and inner layer 3352 are positioned substantially planarly along each other's surfaces. That is, in contrast to previously discussed forms of the present technology, tube 3450 is not pre-formed to have a specific cross-section. Therefore, compared to other forms of technology, tube 3450 does not take up as much space when not in use. In addition, tube 3450 can be easily stored, making it a convenient tube for travel.

[0562] like Figure 9E As shown, tube 3450 expands or opens upon exposure to internal pressure, such as air pressure from a therapeutic device. Air can be forced through connection port 3600, causing the air to fill the interior chamber of tube 3450. The air can then flow to the end of tube 3450 and to another connection mechanism, such as assembly connection ports 3154 and 3155, or to the patient's nose or mouth. Figure 9E As shown in the cross-section of the figure, the tubing sheet 3364 and the outer cover layer 3366 are both located along the upper portion of the cross-section, while the fabric sheet 3360 is located along the lower portion of the cross-section. Because the connection port 3600 and the component connection ports 3154 and 3155 are positioned between the tubing sheet 3364 and the fabric sheet 3360, the air flow from the treatment device is directed to the connection port 3600 and the component connection ports 3154 and 3155 and therefore does not extend between the tubing sheet 3364 and the outer cover layer 3366. In other embodiments, these sheets can be designed to allow air to pass through any of these layers. In addition, the connection port 3600 and the component connection ports 3154 and 3155 can be located in a variety of positions depending on the specific environment or design requirements.

[0563] In some forms, the inner layer 3352 and / or the outer layer 3354 may be formed from a non-extensible material. That is, in some forms, the inner layer 3352 and the outer layer 3354 may not stretch when subjected to internal air pressure, but may still be able to stretch as shown in FIG. Figure 9E 3354. In other embodiments, the inner layer 3352 and / or the outer layer 3354 may be formed from an elastic material that stretches when subjected to internal pressure. In still further embodiments, the inner layer 3352 may comprise a non-stretch fabric, while the outer layer 3354 may comprise a stretch fabric. For example, the inner layer 3352 and the outer layer 3354 may have different stretch or extensibility.

[0564] When formed in the manner described above, the outer layer 3354 can be cut or sliced ​​so that the outer layer 3354 extends around the inlet 3608 of the connection port 3600. In a similar manner, the inner layer 3352 can be cut or sliced ​​so that the inner layer 3352 extends around the component connection ports 3154 and 3155. The outer layer 3354 can be cut or sliced ​​before or after the outer layer 3354 is secured to the inner layer 3352. In some forms, the outer layer 3354 can then be subjected to heat at specific locations so that the film melts and the outer layer 3354 conforms to the inlet 3608 of the connection port 3600. The film associated with the tube sheet 3364 is then allowed to solidify, forming a secure connection between the outer layer 3354 and the connection port 3600. A similar arrangement can be used for the inner layer 3352 and the component connection ports 3154 and 3155.

[0565] In other embodiments, the outer layer 3354 and the inner layer 3352 can be flexible, stretchable, and elastic, allowing the outer layer 3354 and / or the inner layer 3352 to be stretched around the inlet 3608 of the connection port 3600 or similar inlets of the component connection ports 3154 and 3155. Because the outer layer 3354 includes a membrane that contacts the connection port 3600, the membrane can help provide an adequate seal between the outer layer 3354 and the connection port 3600. That is, the elasticity of the outer layer 3354 can cause the outer layer 3354 to shrink around the opening of the connection port 3600. The elasticity of the outer layer 3354 combined with the membrane allows a seal to be formed between the connection port 3600 and the outer layer 3354. Similar to a rubber band, the outer layer 3354 can be pressed against the inlet 3608 by friction rather than by a permanent connection. The friction fit can limit the movement of the connection port 3600, allowing the connection port 3600 to remain in a specific position.

[0566] Additionally, the connection between the outer layer 3354 and the connection port 3600 can be adjusted so that a specific amount of oxygen or air can leak through the connection. This specific leakage can eliminate the need to include a separate valve to allow for handling excess air, oxygen, or waste gas during use.

[0567] In other forms, tube 3450 can be formed so that tube 3450 has a predetermined shape, such as tube 3350. For example, inner layer 3352 and outer layer 3354 can be arranged around a mandrel and then subjected to heating to form a specific cross-section. The layers can then be cut and sealed so that, in addition to being thermoformed, inner layer 3352 and outer layer 3354 are connected to each other during the cutting process.

[0568] 5.3.3.1.2 Strap stiffness

[0569] In some forms, different amounts of conformable film may be used to form components. In some forms, conformable film may be specifically placed along various surfaces. Conformable material may be used to provide specific reinforcement in various areas of a strap or other component. For example, a strap such as strap 3420 is used to help secure patient interface 3000 to the patient's face. In some forms, specific areas of the strap may require increased or additional support when compared to other portions of the strap. Additionally, in some forms, the stretch or elasticity of the strap may be limited by utilizing silicone or polyurethane films.

[0570] See also Figures 5A-5E , depicting a strap. The strap includes an inner layer, a membrane layer, and an outer layer. Although depicted as having an outer layer, it is not necessary to include an outer layer. That is, in some forms, the elastic inner layer 3422 and the membrane layer 3424 can be utilized without the outer layer 3426. Figure 5A As shown, the strap 3420 can interact with the tube 3350 to secure the patient interface 3000 in place relative to the patient. For ease of viewing, the membrane layer 3424 is shown in the figure with a considerable thickness. The membrane layer 3424 can be substantially thinner than the outer layer 3426 or the inner layer 3422. For example, the membrane layer 3424 can be less than 10% of the thickness of the outer layer 3426 or the inner layer 3422.

[0571] See also Figure 5B , a portion of the strap 3420 is depicted isolated from the rest of the patient interface 3000. As shown, the strap 3420 includes an outer layer 3426 and an inner layer 3422. The film layer 3424 is located between these layers and, in some forms, connects these layers to each other. That is, the strap 3420 can be exposed to a heat source, causing the film layer 3424 to melt or change form and cool, connecting the inner layer 3422 and the outer layer 3426 to each other. Figure 5B , film layer 3424 does not extend the full length of inner layer 3422. In other forms, film layer 3424 may extend the entire length of inner layer 3422. In yet other forms, one of these layers may not extend the entire distance of strap 3420. For example, in some forms, outer layer 3426 may only extend the same or similar distance along strap 3420 as film layer 3424. In an example, the entire length of outer layer 3426 can be secured to inner layer 3422 using film layer 3424. Additionally, in some forms, the film may be adhered along the entire length of the shortest layer. The two layers may then be combined and adhered to each other using a thermoplastic or thermosetting material, such as film layer 3424.

[0572] like Figure 5CAs shown, a portion of the inner layer 3422 is laminated with a membrane layer 3424. In some embodiments, the membrane layer 3424 can be formed from the same material as the fabric membrane discussed with respect to the tube 3350. By using the same material in various parts of the patient interface, manufacturing costs can be reduced compared to other embodiments. The inner layer 3422 can be formed from an elastic or stretchable material that conforms to the shape of the patient's head. In addition, the outer layer 3426 can also be made from the same or similar material in the same or similar configuration. These layers can be formed from natural or synthetic materials. In some embodiments, these layers can be fabrics, while in other embodiments, these layers can be rubber or plastic components. In addition, although the inner layer 3422 and the outer layer 3426 are described as being the same or similar materials with the same or similar properties, the inner layer 3422 and the outer layer 3426 can have different properties, such as stretch, stiffness, flexibility, and other properties. The material used for each layer can be selected based on the specific properties desired for the strap 3420.

[0573] See also Figure 5D and 5E In areas without the membrane layer 3424, the inner layer 3422 has a different stretchability than the outer layer 3426. For example, when subjected to a tensile force T, the inner layer 3422 stretches a first distance 3428. As shown, when subjected to the same tensile force T, the membrane layer 3424, together with the outer layer 3426, stretches a second distance 3430. The second distance 3430 is less than the first distance 3428. Thus, the membrane layer 3424 can limit stretching in the specific area where the membrane layer 3424 is applied. That is, while allowing stretching, the membrane layer 3424 can reduce the distance that the inner layer 3422 or the outer layer 3426 can stretch. This type of configuration can be used in specific areas where stepped stretchability is required to provide adequate support for the device. Although the outer layer 3426 is depicted, in some forms of the present technology, the outer layer 3426 may not be utilized. The inner layer 3422 can be used in a strap without the use of another layer such as the outer layer 3426. In this configuration, the straps can be oriented so that the membrane layer 3424 faces away from the patient. In this way, the soft texture of the inner layer 3422 can be against the patient's face. Therefore, the membrane layer 3424 can be used to limit stretch without covering, for example, the outer layer 3426.

[0574] In addition to controlling the rate of stretching of a particular component, the use of the film layer 3424 can also control the rate of recovery. That is, the film layer 3424 can increase the ability of an elastic band, such as the strap 3420, to return to its original, unstretched state.

[0575] In some embodiments, membrane layer 3424 can be used to provide structural support for the strap. In some embodiments, the strap can twist or rotate during use, causing the strap to become dislocated and causing wrinkles and discomfort to the patient. In such cases, a membrane can be used to support the strap and prevent it from rotating or twisting during use.

[0576] Various straps may be used to support the cushion assembly so that the cushion assembly provides an adequate seal for the patient's nose or mouth area. Figure 5F As shown, head strap 3432 is shown in conjunction with tube 3434 in place of patient interface 3436 .

[0577] See also Figure 5G , depicting a head strap component. The head strap 3432 may include various features as described above. Figure 5H , depicts an exploded view of head strap 3432. As shown, head strap 3432 includes an inner layer 3437, an outer layer 3438, straps 3439-3442, and a cushion 3443. Inner layer 3437 and outer layer 3438 surround or sandwich some or all of the components. As shown, inner layer 3437 and outer layer 3438 completely sandwich cushion 3443 and surround a portion of straps 3439-3442. In some embodiments, inner layer 3437 and / or outer layer 3438 may be laminated with a film or silicone or polyurethane layer, as previously described with reference to tube 3350. Inner layer 3437 and outer layer 3438 may be aligned and then subjected to heat, causing the film between inner layer 3437 and outer layer 3438 to melt and then connecting the layers together. Inner layer 3437 and outer layer 3438 may also be adhered or connected to cushion 3443, as shown. In other embodiments, the film layer may not be present in the area of ​​liner 3443. That is, liner 3443 may be located in a pocket between inner layer 3437 and outer layer 3438, but liner 3443 may not be physically secured to either inner layer 3437 or outer layer 3438. Furthermore, in some embodiments, straps 3439-3442 may be secured using an adhesive. However, in other embodiments, straps 3439-3442 are secured to inner layer 3437 and outer layer 3438 via a film.

[0578] The components of the head strap 3432 may be spaced apart in various orientations. Figure 5GAs shown, strap 3442 is separated from strap 3441 by a portion of inner layer 3437 and a portion of outer layer 3438. Similarly, strap 3442 is separated from pad 3443 by a portion of inner layer 3437 and outer layer 3438. Various other configurations may be used. For example, in some forms, strap 3442 may contact strap 3441. In further forms, strap 3442 and strap 3441 may be a single piece. Other variations are also possible. For example, pad 3443 may be larger or smaller, or may not exist. By changing the size, shape, and orientation of various components, the feel of the components can be changed and customized. As shown, head strap 3432 may have various different stretch zones. Zone X1 includes straps 3439-3442 and they have a first stretchability and, in some forms, may be substantially inextensible. The second region is region X2, which includes the straps 3439-3442, a portion of the inner layer 3437, and the outer layer 3438. This region has a second stretchability, but can also be substantially inextensible. The third region is region X3 between the ends of the straps 3439-3442 and the liner 3443. This region has a third stretchability. The final stretch zone is region X4, which includes the liner 3443, the inner layer 3437, and the outer layer 3438. These various regions can be varied depending on the manufacturer's intent or desired properties.

[0579] like Figure 5G The configuration shown allows for a variety of features to be present in a single head strap 3432 without the need for various connecting components that add bulk and may be uncomfortable. By integrating the membrane as the connecting material, the weight of the head strap can also be reduced compared to other forms.

[0580] 5.3.3.2 Positioning and Stabilizing Structures According to Other Examples of the Present Technology

[0581] Additional examples of positioning and stabilizing structures are described below. It should be noted that the features described below can be used or combined with features described in other examples of this disclosure. For example, the tubes described below can be used with the cushion modules / cushion assemblies described in other examples, and vice versa. In addition, individual features of any structure described in any example can be used or combined with features in other examples.

[0582] 5.3.3.2.1 Head casing

[0583] like Figure 10 and 11As shown, a non-invasive patient interface 9000, 10000 according to an example of the present technology may include the following functional aspects: a seal-forming structure 9100, an inflatable chamber 9200, a positioning and stabilizing structure 9300, at least one vent 9400, 940-1, and a device for connecting to an air circuit (e.g., Figures 1A-1C 9600 of a form of connection port 9600 of the air circuit 4170 shown in FIG. In the example, the seal-forming structure 9100 and the plenum chamber 9200 are provided by a cushion module 9150. The cushion module 9150 in this example is a bracket cushion module. In other examples, it can be a nasal pillow cushion assembly or other type of cushion assembly.

[0584] In some forms of the present technology, the positioning and stabilizing structure 9300 includes one or more tubes 9350 that convey pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example through the plenum 9200 and seal forming structure 9100. Figure 10 and Figure 11 In the illustrated form of the present technology, the positioning and stabilizing structure 9300 includes two tubes 9350 that deliver air from the air circuit 4170 to the seal-forming structure 9100. The tubes 9350 are an integral part of the positioning and stabilizing structure 9300 of the patient interface 9000 to position and stabilize the seal-forming structure 9100 of the patient interface to the appropriate portion of the patient's face (e.g., nose and / or mouth). This allows the conduit of the air circuit 4170, which provides the pressurized air flow, to connect to the connection port 9600 of the patient interface at a location other than the front of the patient's face, which may be unsightly for some people. While a pair of tubes 9350 has some advantages (described below), in some examples, the positioning and stabilizing structure 9300 includes only a single tube 9350 configured to cover the patient's head on one side. A strap or other stabilizing member can be provided on the other side of the patient's head between the top end of the single tube 9350 and the seal-forming structure 9100 to provide a balancing force on the seal-forming structure 9100.

[0585] Because air can be included and passed through the headband tubes 9350 to deliver pressurized air from the air circuit 4170 to the patient's airway, the positioning and stabilizing structure 9300 can be described as inflatable. It should be understood that an inflatable positioning and stabilizing structure 9300 does not require all components of the positioning and stabilizing structure 9300 to be inflatable. For example, in Figure 10 and 11 In the example shown, the positioning and stabilizing structure 9300 includes an inflatable headband tube 9350 and a non-inflatable strap 9310.

[0586] In some forms of this technology, Figure 10 and 11The patient interfaces 9000, 10000 shown may include a connection port 9600 located near the top, side, or back of the patient's head. Figure 10 and Figure 11 In the form of the present technology shown in FIG, a connection port 9600 is located at the top of the patient's head. In these examples, the patient interfaces 9000, 10000 include an elbow 9610 to which the connection port 9600 is disposed. The elbow 9610 can rotate relative to the positioning and stabilizing structure 9300 (e.g., via a swivel ring 9614) to decouple movement of a conduit connected to the connection port 3600 from the positioning and stabilizing structure 3300. The elbow 9610 can be...

Claims

1. A positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head for positive airway pressure treatment of sleep-disordered breathing, the positioning and stabilizing structure comprising: at least one gas delivery tube to deliver a flow of air to an entrance to the patient's airway via a seal-forming structure, each gas delivery tube being constructed and arranged to contact, in use, a region of the patient's head at least above a supra-auricular base of the patient's head, each gas delivery tube comprising a tube wall defining a hollow interior through which air can flow to the seal-forming structure, each gas delivery tube comprising: an upper tube portion configured to extend, in use, from a position on the top of the patient's head to a position along the side of the patient's head or face, the upper tube portion comprising a fabric material and / or a foam material; and a lower tube portion configured to extend from a position along the side of the patient's head or face to a position adjacent to an entrance to the patient's airway, the lower tube portion comprising a fabric material and / or a foam material, One of the lower tube portion and the upper tube portion has a greater rigidity than the other of the lower tube portion and the upper tube portion.

2. The positioning and stabilizing structure according to claim 1, wherein: The upper tube portion includes a first end configured to abut an upwardly facing surface of the patient's head in use and a second end configured to abut a laterally facing surface of the patient's head in use.

3. A positioning and stabilizing structure as claimed in claim 1 or claim 2, wherein: The lower tube portion includes a first end configured to abut a laterally facing surface of the patient's head in use and a second end configured to be in structural connection with the seal.

4. A patient interface comprising a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway to seal, in use, a flow of air delivered at a therapeutic pressure of at least 6 cm H2O above ambient air pressure throughout the patient's breathing cycle; and A positioning and stabilising structure as claimed in any one of claims 1 to 3, for providing a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, for use in positive airway pressure therapy for sleep apnea.

5. A positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on a patient's head for positive airway pressure therapy of sleep-disordered breathing, the positioning and stabilizing structure comprising: at least one gas delivery tube to deliver a flow of air to an entrance to the patient's airway via a seal-forming structure, each gas delivery tube being constructed and arranged to contact, in use, a region of the patient's head at least above a supra-auricular base of the patient's head, each gas delivery tube comprising a tube wall defining a hollow interior through which air can flow to the seal-forming structure, each gas delivery tube comprising: a first length of elongated material having first and second opposing edges along its length; a second length of elongated material having opposing first and second edges along its length; and a third length of elongated material having first and second opposing edges along its length, wherein the first section of elongated material is joined to the second section of elongated material along a first edge of the first section of elongated material and a second edge of the second section of elongated material, and the second section of elongated material is joined to the third section of elongated material along a first edge of the second section of elongated material and a second edge of the third section of elongated material, so as to form a tube wall of the gas delivery tube, and The outer layer of the gas delivery tube comprises fabric material and / or foam material.

6. A positioning and stabilizing structure as claimed in claim 5, wherein: Each gas delivery tube is configured to extend, in use, from a position on the top of the patient's head along the side of the patient's face to a position adjacent the entrance to the patient's airway.

7. A positioning and stabilising structure as claimed in any one of claims 5 to 6, wherein: The first length of elongated material, the second length of elongated material, and the third length of elongated material each include a plurality of layers.

8. A patient interface comprising a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway to seal, in use, a flow of air delivered at a therapeutic pressure of at least 6 cm H2O above ambient air pressure throughout the patient's breathing cycle; and A positioning and stabilising structure as claimed in any one of claims 5 to 7, to provide a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, for use in positive airway pressure therapy for sleep apnea.

9. A positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on a patient's head for positive airway pressure therapy of sleep-disordered breathing, the positioning and stabilizing structure comprising: at least one gas delivery tube to deliver a flow of air to an entrance to the patient's airway via a seal-forming structure, each gas delivery tube being constructed and arranged to contact, in use, a region of the patient's head at least above a supra-auricular base of the patient's head, each gas delivery tube comprising a tube wall defining a hollow interior through which air can flow to the seal-forming structure, each gas delivery tube comprising: a patient contacting portion configured to contact a body of the patient; a non-patient contacting portion configured to be oriented away from the patient's body in use; and at least one seam for connecting the patient contacting portion and the non-patient contacting portion; The at least one seam includes a rigidifying element embedded in or laminated on the seam to provide rigidity to the gas delivery tube.

10. A patient interface comprising a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway to seal, in use, a flow of air delivered at a therapeutic pressure of at least 6 cm H2O above ambient air pressure throughout the patient's breathing cycle; and A positioning and stabilizing structure as described in claim 9 to provide a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head for positive airway pressure treatment of sleep-disordered breathing.

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