Inflatable headgear and patient interface

Abstract

This technology relates to one or more of the following: screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory diseases. This technology also relates to medical devices or apparatus and their use. [Solution] In particular, the present technology relates to a headgear for supplying pressurized air to a patient, comprising an inflatable headgear tubing that moves from a compressed state to an inflated state to form a conduit for supplying pressurized air to the patient, wherein when the headgear tubing is in a compressed state, the headgear tubing is elastically deformable and can be folded on its own. The headgear may further include a rigidizer.

Description

[Technical Field]

[0001] Some of the disclosures in this patent document include content that is protected by copyright. The copyright holder retains all copyrights to any other purpose, except that any reproduction of this patent document or this patent disclosure by fax by any person is permitted if it is included in the patent files or records of the Japan Patent Office. 1. Cross-reference of related applications

[0002] This application claims the interests of Singapore Patent Application No. 10202006317, filed on 30 June 2020, and Singapore Patent Application No. 10202011064, filed on 6 November 2020, the contents of which are incorporated herein by reference in their entirety. [Background technology]

[0003] 2. Technical Background 2.1 Field of Technology This technology relates to one or more of the following: screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory diseases. This technology also relates to medical devices or apparatus and their use. 2.2 Description of Related Technologies 2.2.1 Human respiratory system and its diseases

[0004] The body's respiratory system facilitates gas exchange. The nose and mouth form the entry points to the patient's airways.

[0005] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they proceed deeper into the lungs. The main function of the lungs is gas exchange, taking oxygen from the air into the venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchioles form the airways for conduction and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory zone. See (Non-Patent Document 1) below.

[0006] There are a range of respiratory diseases. Certain diseases can be characterized by specific events (e.g., apnea, hypopnea, and hyperpnea).

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

[0008] Obstructive sleep apnea (OSA) is one form of sleep-disordered breathing (SDB) and is characterized by events such as closure or obstruction of the upper airway during sleep. This is the result of a combination of an abnormally small upper airway and the normal loss of muscle tone in the regions of the tongue, soft palate, and posterior oropharyngeal wall during sleep. Due to such a condition, the breathing stops of affected patients typically last for 30 to 120 seconds and sometimes the breathing stops 200 to 300 times a night. As a result, excessive daytime sleepiness occurs, which can cause cardiovascular diseases and brain damage. This syndrome is a common disease, particularly common in middle-aged overweight men, but patients have no awareness of the symptoms. See Patent Document 1 (Sullivan).

[0009] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of respiratory control in which there is a rhythmic alternation of increased and decreased ventilation known as the CSR cycle. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CSR is accompanied by recurrent sleep-wake cycles, which cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0010] Respiratory failure is a general term for respiratory diseases in which the lungs are unable to adequately inhale oxygen or exhale CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following conditions:

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

[0012] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia while awake, in the absence of other clearly identifiable causes of hypoventilation. Symptoms include shortness of breath, morning headache, and excessive daytime sleepiness.

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

[0014] Neuromuscular diseases (NMDs) are a broad term encompassing numerous illnesses and diseases that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage, which can lead to inability to walk, wheelchair confinement, dysphagia, respiratory muscle weakness, and ultimately death due to respiratory failure. Neuromuscular disorders can be classified into rapidly progressive and slowly progressive types: (i) rapidly progressive disorders: characterized by muscle damage that worsens over several months and leads to death within several years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over several years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increased general weakness, dysphagia, dyspnea at exertion and rest, fatigue, drowsiness, morning headache, and difficulty concentrating and changing mood.

[0015] Chest wall disorders are a group of thoracic deformities that cause dysfunction in the connection between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive disorders and share the potential for long-term excess carbon dioxide respiratory failure. Scoliosis and / or kyphosis can develop into severe respiratory failure. Symptoms of respiratory failure include: exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0016] A range of treatments are used to treat or improve such conditions. Furthermore, otherwise healthy individuals can also take advantage of preventive treatments for respiratory diseases. However, these have several drawbacks. 2.2.2 Therapy

[0017] A variety of respiratory therapies (e.g., continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) are used to treat one or more of the respiratory diseases mentioned above. 2.2.2.1 Respiratory pressure therapy

[0018] Respiratory pressure therapy is the application of supplying air to the airway entrance at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient's entire respiratory cycle (in contrast to negative pressure therapy such as tank ventilators or cuirasses).

[0019] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action involves, for example, pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, thereby functioning as an air splint and preventing upper airway obstruction. Since CPAP therapy for OSA can be voluntary, patients may choose not to adhere to treatment if they notice one or more of the following regarding the device used to deliver the treatment: discomfort, difficulty of use, high cost, or lack of aesthetic appeal.

[0020] Non-invasive ventilation (NIV) provides ventilatory support to the patient through the upper airway to assist with breathing and / or maintain adequate oxygen levels throughout the body by performing some or all of the respiratory function. Ventilation support is provided through a non-invasive patient interface. NIV is used to treat forms of respiratory failure and pulmonary stenosis, such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0021] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these treatments can be improved. 2.2.2.2 Flow Therapy

[0022] Not all respiratory therapies are intended to deliver a prescribed therapeutic pressure. In some respiratory therapies, prescribed ventilatory volume is intended by delivering an inspiratory flow profile (perhaps superimposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy with a controlled or high-concentration gas flow may only be used as an aid to the patient's own spontaneous breathing. In one embodiment, high-flow therapy (HFT) is the delivery of a continuous, heated, humidified airflow to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that can be maintained nearly constant throughout the respiratory cycle. The therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT is used to treat OSA, CSR, respiratory failure, COPD, and other respiratory diseases. One mechanism of action is that providing a high flow of air to the airway inlet improves ventilation efficiency by allowing exhaled CO2 to be flushed or pushed out from the patient's anatomical dead space. Therefore, HFT is sometimes called dead space therapy (DST). Other benefits include improved warmth and humidification (perhaps due to secretion control) and a gradual increase in airway pressure. As an alternative to a constant flow rate, therapeutic flow rates can follow a fluctuating profile throughout the respiratory cycle.

[0023] Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. A physician may prescribe a continuous flow of oxygen-enriched air delivered to the patient's airway at a specified flow rate (e.g., 1 liter / minute (LPM), 2 LPM, 3 LPM) at a specified oxygen concentration (the oxygen fraction in the ambient air is 21% to 100%). 2.2.2.3 Supplementary oxygen

[0024] In certain patients, adding supplemental oxygen to a pressurized airflow can provide a combination of oxygen therapy and respiratory pressure therapy or high-frequency therapy (HFT). When oxygen is added to respiratory pressure therapy, this is called oxygen-assisted respiratory therapy (RPT). When oxygen is added to HFT, the resulting treatment is called oxygen-assisted HFT. 2.2.3 Respiratory Therapy Systems

[0025] These respiratory therapies may be provided by respiratory therapy systems or devices. Such systems and devices may also be used for screening, diagnosis, or monitoring without treating the disease.

[0026] A respiratory therapy system may include respiratory pressure therapy devices (RPT devices), air circuits, humidifiers, patient interfaces, oxygen sources, and data management. 2.2.3.1 Patient Interface

[0027] A patient interface may be used to provide the wearer with an interface to a respiratory appliance, for example, by providing airflow to the airway inlet. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy applied, the patient interface may form a seal with, for example, the area of ​​the patient's face, thereby facilitating gas delivery at a pressure of sufficient dispersion along with the ambient pressure for the administration of the therapy (for example, at a positive pressure of approximately 10 cmH2O relative to the ambient pressure). In other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of gas to the airway at a positive pressure of approximately 10 cmH2O. In the case of flow therapy such as nasal HFT, the patient interface is configured to deliver air to the nostrils (while explicitly avoiding a complete seal). An example of such a patient interface is a nasal cannula.

[0028] Certain other mask systems may be functionally unsuitable in this field. For example, masks intended purely for decorative purposes may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to protect against water ingress from higher external pressures and to prevent the retention of internal air at pressures higher than the ambient pressure.

[0029] Certain masks may be clinically undesirable in this technology (for example, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0030] In certain masks, if the patient must insert a portion of the mask structure into their mouth and create and maintain a seal through their lips, this technology may be uncomfortable or impractical.

[0031] Certain masks may be impractical for use while sleeping (for example, when sleeping on your side in bed with your head on a pillow).

[0032] There are several challenges in designing patient interfaces. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Because the head contains bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout the respiratory treatment period.

[0033] Due to these challenges, some masks, especially when worn for extended periods or when the patient is unfamiliar with the system, may be intrusive, aesthetically undesirable, expensive, poorly fitting, difficult to use, and uncomfortable for one or more reasons. Using an incorrectly sized mask can lead to decreased compliance, reduced comfort, and a poorer patient outcome. While pilot-specific masks, personal protective equipment (e.g., filter masks), masks designed as part of a SCUBA mask, or masks used for anesthesia may be tolerable for their original purpose, they can be undesirable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient compliance with treatment, especially if the mask needs to be worn during sleep.

[0034] CPAP therapy is highly effective in treating certain respiratory conditions, provided the patient consents to the treatment. Patients may refuse treatment if the mask is uncomfortable or difficult to use. Since patients are often advised to wash their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may be unable to clean the mask, which can affect patient compliance.

[0035] Masks designed for other purposes (e.g., pilot use) may be unsuitable for treating sleep-disordered breathing, while masks designed for treating sleep-disordered breathing may be suitable for other purposes.

[0036] For these reasons, the patient interface for CPAP delivery during sleep forms a distinct field. 2.2.3.1.1 Pressurized air conduit

[0037] In one type of treatment system, a flow of pressurized air is supplied separately to the patient interface through conduits in an air circuit that fluidizes the patient interface, such that when the patient interface is positioned on the patient's face during use, the conduits extend forward away from the patient's face. This may also be referred to as an "elephant trunk" style interface.

[0038] Some patients find such interfaces unsightly, which can lead them to reluctantly wear them, resulting in decreased patient compliance. In addition, the conduits connecting to the interface on the front of the patient's face can easily become entangled in bedding. 2.2.3.1.2 Pressurized air conduits used for positioning / stabilizing seal-forming structures

[0039] An alternative type of treatment system that attempts to address these problems includes a patient interface in which a tube that delivers pressurized air to the patient's airway also functions as part of the headgear, positioning and stabilizing the sealing portion of the patient interface in the appropriate location on a part of the patient's face. This type of patient interface may be called an integrated “headgear tubing” or “conduit headgear.” Such a patient interface allows a conduit in an air circuit that provides a flow of pressurized air from a respiratory pressure therapy device to connect 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 Application Publication 2007 / 0246043, which is incorporated herein by reference, in which the conduit connects to a tube in the patient interface through a portion positioned during use on the top of the patient's head.

[0040] Philips DreamWear® masks include headgear tubing. The length of the DreamWear® headgear tubing is not adjustable. As a result, DreamWear® headgear is offered in three different sizes to accommodate a variety of patient face sizes. Offering more different sizes would increase the complexity and cost of manufacturing the headgear and could result in larger packaging. In addition, supplying masks in discrete sizes may limit the range of masks that can be applied to the heads of patients of different sizes. If patients are forced to choose from individual sizes that cannot be adjusted in length, they are more likely to be unable to achieve what they consider a "perfect" fit.

[0041] Patient interfaces incorporating headgear tubing can offer several advantages, such as avoiding unsightly and cumbersome conduits that connect to the interface at the front of the patient's face. However, it is desirable that patient interfaces incorporating headgear tubing be comfortable for the patient to wear for extended periods while forming an effective seal with the patient's face when the patient is sleeping. 2.2.3.1.3 Seal-forming structure

[0042] The patient interface may include a seal-forming structure. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0043] Patient interfaces can be partially characterized according to the design intent of where the seal-forming structure engages with the face during use. In one form of patient interface, the seal-forming structure may include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and nasal bridge region of the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the oral region by forming a seal, for example, on the lower lip region of the face during use. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the oral region during use. These different types of patient interfaces may be known by various names such as nasal masks, full-face masks, nasal pillows, nasal puffs, and mouth-nasal masks, depending on their manufacturer.

[0044] A sealing structure that may be effective in one area of ​​a patient's face may be unsuitable in another area due to, for example, different facial shapes, structures, variability, and sensitive areas of the patient's face. For instance, the sealing portion of swimming goggles that rests on a patient's forehead may be unsuitable for use over the patient's nose.

[0045] A specific seal-forming structure can be designed for mass production so that a single design fits a wide range of different face shapes and sizes, ensuring comfort and effectiveness. To form the sealing portion, one or both the patient's face shape and the mass-produced patient interface seal-forming structure must be adapted to a certain extent, even if there is some mismatch between them.

[0046] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal the patient's face when force is applied to the patient interface while the seal-forming structure is engaged with the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or it may include a molded or formed surface of a resilient sealing element composed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will form between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0047] Another type of seal-forming structure uses a thin flap seal positioned around the perimeter of the mask to provide a self-airtight seal against the patient's face when positive pressure is applied inside the mask. Similar to the previously mentioned types of seal-forming structures, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or leakage may occur from the mask. Furthermore, if the shape of the seal-forming structure does not conform to the patient's shape, creases or buckling may occur in the seal-forming portion during use, leading to leakage.

[0048] Other types of seal-forming structures may include, for example, friction-fitting elements inserted into the nostrils, but some patients may find these seal-forming parts uncomfortable.

[0049] Another form of seal-forming structure may use adhesive to achieve a seal. Some patients may find it inconvenient to constantly attach or remove the adhesive to their face.

[0050] The technology for forming a patient interface seal within a certain range is disclosed in the following patent applications (assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

[0051] One form of nasal pillow is found in the Adam circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.), which was transferred to Puritan-Bennett Corporation.

[0052] ResMed Limited manufactures the following products using nasal pillows: SWIFT® Nasal Pillow Mask, SWIFT® II Nasal Pillow Mask, SWIFT® LT Nasal Pillow Mask, SWIFT® FX Nasal Pillow Mask, and MIRAGE LIBERTY® Full Face Mask. The following patent applications, assigned to ResMed Limited, describe embodiments of nasal pillow masks: International Publication 2004 / 073,778 (in particular, describing the features of ResMed Limited's SWIFT® nasal pillow), U.S. Patent Application 2009 / 0044808 (in particular, describing the features of ResMed Limited's SWIFT® LT nasal pillow); International Publication 2005 / 063,328 and International Publication 2006 / 130,903 (in particular, describing the features of ResMed Limited's MIRAGE LIBERTY® full-face mask); and International Publication 2009 / 052,560 (in particular, describing the features of ResMed Limited's SWIFT® FX nasal pillow). 2.2.3.1.4 Positioning and Stabilization

[0053] The seal-forming structures of patient interfaces used in positive pressure air therapy are subjected to corresponding forces from the air pressure that can disrupt the seal. Therefore, various techniques are employed to position the seal-forming structures and maintain a seal over the appropriate portion of the face.

[0054] In one technology, adhesive joints are used. See, for example, U.S. Patent Application Publication No. 2010 / 0000534. However, the use of adhesive joints can sometimes cause discomfort.

[0055] In other technologies, one or more straps and / or stabilization harnesses are used. In many such harnesses, one or more of the following apply: poor fit, bulkiness, discomfort, and difficulty of handling. 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0056] Respiratory pressure therapy (RPT) devices can be used individually or as part of a system for the delivery of one or more of the above-mentioned therapies, for example, by activating the device to generate an air delivery flow to the airway interface. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Therefore, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0057] Pneumatic generators are well known in a wide range of applications (e.g., industrial-scale ventilation systems). However, pneumatic generators for medical applications have specific requirements that cannot be satisfied by more general pneumatic generators (e.g., reliability, size, and weight requirements for medical devices). In addition, even devices designed for medical treatment may not be free from defects related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0058] One example of a specific requirement for a particular RPT device is acoustic noise.

[0059] [Table 1]

[0060] Table of noise output levels for conventional RPT devices (measured using only one sample in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0061] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another embodiment of an RPT device is the ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can provide assistance for invasive and non-invasive independent breathing for a range of patients for the treatment of multiple conditions (e.g., NMD, OHS, and COPD).

[0062] The ResMed Elisee® 150 and ResMed VSIII® ventilators can provide invasive and non-invasive dependent respiratory support suitable for adult or pediatric patients for the treatment of multiple conditions. These ventilators offer volumetric and pneumatic ventilation modes using single or dual limb circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) configured to supply airflow to the patient's airway. In some cases, the airflow may be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface as described above via an air circuit.

[0063] Device designers may be presented with countless options. Because design criteria often conflict, certain design choices may be far removed from convention, or even unavoidable. Furthermore, the comfort and effectiveness of a particular design can be significantly affected by even minor changes in one or more parameters. 2.2.3.3 Air Circuit

[0064] An air circuit is a conduit or tube constructed and positioned so that airflow moves between two components of a respiratory therapy system (e.g., an RPT device and a patient interface) during use. In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation. 2.2.3.4 Humidifier

[0065] Delivering airflow without humidification can lead to airway dryness. Using a humidifier with the RPT device and patient interface generates humidifying gas, minimizing nasal mucosal dryness and increasing patient airway comfort. Additionally, in cooler climates, adding warm air to the facial area around the patient interface generally provides greater comfort than cool air.

[0066] While a certain range of artificial humidification devices and systems are publicly known, they do not meet the specific requirements of medical humidifiers.

[0067] Medical humidifiers are typically used to increase the humidity and / or temperature of an airflow relative to the ambient air as needed, when a patient is sleeping or at rest (e.g., in a hospital). Medical humidifiers placed by the bedside may be small in size. They may be configured to humidify and / or heat only the airflow delivered to the patient, and not the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can humidify the air inhaled into the patient's body through breathing, but these systems also humidify and / or heat the entire room, which can be uncomfortable for the occupant. Furthermore, medical humidifiers may have stricter safety constraints than industrial humidifiers.

[0068] Although numerous medical humidifiers are publicly known, these humidifiers may suffer from one or more defects. Specifically, some medical humidifiers may not humidify properly, or they may be difficult or inconvenient for patients to use. 2.2.3.5 Oxygen source

[0069] Experts in this field recognize that exercise for patients with respiratory failure offers long-term benefits, including slowing disease progression, improving quality of life, and extending patient lifespan. However, many stationary forms of exercise, such as treadmills and exercise bikes, are too strenuous for these patients. Consequently, the need for mobility has long been recognized. Until recently, this mobility was achieved by using small compressed oxygen tanks or cylinders mounted on carts with wheels. The drawbacks of these tanks are the limited amount of oxygen they contain and their heavy weight, approximately 50 pounds when mounted.

[0070] Oxygen concentrators have been used for approximately 50 years to supply oxygen for respiratory therapy. Conventional oxygen concentrators are bulky and heavy, making normal walking activities difficult and impractical. Recently, companies that manufacture large, stationary oxygen concentrators have begun developing portable oxygen concentrators (POCs). The advantage of POCs is that they can theoretically generate an unlimited supply of oxygen. Various systems necessary for generating oxygen-enriched gas are condensed to make these devices small enough to be portable. POCs try to utilize the generated oxygen as efficiently as possible to minimize weight, size, and power consumption. This can be achieved by delivering oxygen as a series of pulses, with each pulse or "bolus" timed to coincide with the start of inhalation. This therapeutic mode is known as pulsed oxygen delivery (POD) or demand mode, in contrast to conventional continuous flow delivery, which is more suitable for stationary oxygen concentrators. 2.2.3.6 Data Management

[0071] For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant," for example, whether the patient is using their RPT device in accordance with one or more "compliance rules." For example, a compliance rule for CPAP treatment might require a patient to use their RPT device for at least four hours per night for at least 21 consecutive days out of a 30-day period in order to be considered compliant. To determine patient compliance, an RPT device provider (e.g., a healthcare provider) may manually collect data describing the patient's treatment with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. If a healthcare provider determines that a patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify third parties that the patient is compliant.

[0072] In patient treatment, there may be other ways in which communication of treatment data to third parties or external systems may be beneficial.

[0073] Existing processes for communicating and managing such data can be costly, time-consuming, and prone to errors. 2.2.3.7 Ventilation Technology

[0074] Some forms of treatment systems may include vents to expel exhaled carbon dioxide. These vents may allow gas to flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings).

[0075] This vent may be equipped with an orifice, and when the mask is in use, gas can flow through the orifice. In many cases, such vents are noisy. In other cases, they may become blocked during use, resulting in insufficient airflow. In some cases, the sleep of the patient 1000 and the person sharing the bed 1100 may be disturbed, for example, due to noise or concentrated airflow.

[0076] ResMed Limited has developed several improved mask ventilation technologies. See below: International Patent Application Publication WO1998 / 034,665; International Patent Application Publication WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication US2009 / 0050156; U.S. Patent Application Publication 2009 / 0044808.

[0077] Table of noise levels for conventional masks (ISO 17510-2:2007, 10 cmH2O pressure at 1 m)

[0078] [Table 2]

[0079] ( * (Only one sample was measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744.)

[0080] The sound pressure values ​​of various objects are listed below.

[0081] [Table 3]

[0082] 2.2.4 Screening, diagnostic, and monitoring systems

[0083] Polysomnography (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary disorders, and typically requires specialized clinical staff for system application. In PSG, typically 15-20 contact sensors are placed on the patient to record various bodily signals (e.g., electroencephalography (EEG), electrocardiogram (ECG), electrooculography (EOG), electromyography (EMG)). For PSG of sleep-disordered breathing, patients needed to be observed over two nights in a specialized hospital; the first night was purely for diagnosis, and the second night was necessary for clinicians to titrate treatment parameters. Therefore, PSG is costly and inconvenient. In particular, screening / diagnosis / monitoring of sleep-disordered breathing is unsuitable for home use.

[0084] Generally, screening and diagnosis involve identifying a disease based on its signs and symptoms. Screening typically yields true / false results indicating whether a patient's SDB warrants further investigation, while diagnosis often provides clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the course of a disease can continue indefinitely. Some screening / diagnostic systems are suitable only for screening / diagnosis, while others can also be used for monitoring.

[0085] Clinical professionals can appropriately screen, diagnose, or monitor patients based on visual observation of PSG signals. However, there are situations where clinical professionals are unavailable or cannot be paid. Clinical professionals may have differing opinions regarding a patient's condition. Furthermore, a particular clinical professional may apply different criteria over time.

[0086] It is desirable to overcome or improve at least one of the aforementioned problems, or at least provide a useful alternative. [Prior art documents] [Patent Documents]

[0087] [Patent Document 1] U.S. Patent No. 4,944,310 [Non-patent literature]

[0088] [Non-Patent Document 1] “Respiratory Physiology”, by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012 [Overview of the project] [Means for solving the problem]

[0089] 3. A brief explanation of the technology

[0090] This technology relates to providing medical devices used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases, which have one or more of the following advantages: improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0091] A first aspect of this technology relates to an apparatus used for screening, diagnosing, monitoring, improving, treating or preventing respiratory diseases.

[0092] Another aspect of this technology relates to a method used for screening, diagnosing, monitoring, improving, treating or preventing respiratory diseases.

[0093] One aspect of a particular form of this technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0094] The patient interface includes a plenum chamber pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure, a seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway to deliver airflow at a therapeutic pressure at least 6 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle in use, and a headgear to provide force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0095] One embodiment of this technology includes a headgear and / or patient interface for delivering a supply of pressurized, breathable gas or air to the entrance of a patient's airway.

[0096] One embodiment of this technology relates to a headgear. The headgear is designed to provide a force to hold a seal-forming structure, constructed and positioned to form a seal with the area of ​​the patient's face surrounding an inlet to the patient's airway, in a therapeutically effective position on the patient's head for the delivery of an airflow at a therapeutic pressure at at least 6 cmH2O higher than ambient air pressure throughout the patient's entire respiratory cycle in use. The headgear includes at least one air inlet, at least one air outlet that is fluidly in communication with and positionable with the seal-forming structure in use, headgear tubing extending between the air inlet and air outlet, and a tension structure for providing a force to maintain the seal-forming structure in the position of use. The headgear tubing is sized to be expandable in one direction from a collapsed state to an expanded state in order to form a conduit for supplying pressurized air to the patient. When the headgear tubing is collapsed, the headgear tubing is foldable on its own.

[0097] In a particular embodiment, the headgear tubing further includes a fastening portion that fluidly connects at least two material pieces that at least partially form the headgear tubing. The fastening portion is movable between a first position and a second position. The interior of the passage is exposed to the periphery in the first position. In the second position, the passage is configured to carry airflow between at least one air inlet and at least one air outlet.

[0098] In a particular form, a) the fastening portion is a zipper, tape, or hook-and-loop fastener; b) the fastening portion is formed as part of a double-walled film and configured to expose the inner surface of the double-walled film in the open position; c) the fastening portion extends at least partially between at least one air inlet and at least one air outlet; d) the fastening portion is located in a first position adjacent to at least one air outlet and a second position adjacent to at least one air inlet; and / or e) the fastening portion is located on the non-patient contact side of the headgear tubing.

[0099] One embodiment of this technology relates to a headgear. The headgear is designed to provide a force to hold a seal-forming structure, constructed and positioned to form a seal with the area of ​​the patient's face surrounding an inlet to the patient's airway, in a therapeutically effective position on the patient's head for the delivery of an airflow at a therapeutic pressure at at least 6 cmH2O higher than ambient air pressure throughout the patient's entire respiratory cycle in use. The headgear includes at least one air inlet that can be positioned to overlap the cranial area of ​​the patient's head in the position of use (or during use), at least one air outlet that can be positioned in fluid communication with the seal-forming structure when in the position of use, headgear tubing extending between the air inlet and air outlet, and a tension structure that provides a force to maintain the seal-forming structure in the position of use. The headgear tubing is sized to be expandable in one direction from a collapsed state to an expanded state in order to form a conduit for supplying pressurized air to the patient. When the headgear tubing is collapsed, the headgear tubing is foldable on its own.

[0100] The advantages of the headgear described in the previous paragraph are that it is less bulky than known headgears, and because the air tubing is integrated with the headgear, it is easy for the patient to use as there is no need to attach clips or straps to secure loose parts. The conduit of the headgear allows it to fit well to the patient's head, enabling improved comfort of use. When crushed, the headgear can be deformed and folded compactly for storage.

[0101] Another embodiment of the present technology relates to a headgear for supplying pressurized air to a patient. The headgear is intended to provide a force that holds a seal-forming structure, constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, in a therapeutically effective position on the patient's head for the delivery of an airflow at a therapeutic pressure at at least 6 cmH2O higher than ambient air pressure throughout the patient's entire respiratory cycle in use. The headgear includes a headgear tubing. The headgear tubing is formed from a composite material and includes a double-walled film having an internal cavity and an external surface. The external surface includes a first side and a second side. The film is impermeable to pressurized air. The first fabric layer is connected to the first side, and the second fabric layer is connected to the second side. The headgear tubing has a first transverse axis extending generally laterally along its length and a second transverse axis extending generally laterally with respect to the first transverse axis. The headgear tubing is more expandable in the first direction along the first horizontal axis than in the second direction along the second horizontal axis.

[0102] The headgear is less bulky than previous headgear designs, and easier for patients to put on and take off. When inflation occurs preferentially along one horizontal axis, the headgear conforms well to the patient's head, allowing for improved comfort. The inflated state also provides a "cushioning" effect when the patient lies down. The fibers may have properties for managing temperature and moisture to further enhance the patient's level of comfort. When compressed, the headgear is scrunchable and can be folded into a compact size for storage.

[0103] In some embodiments, the composite material has a load of 15 N / mm². 2 It has a bending modulus of less than .

[0104] Advantageously, composite materials within the range of flexural modulus disclosed herein allow the headgear to be scrunchable, so that it can be compressed for storage when not in use and folded to a compact size. This deformability allows the headgear to change its shape in response to compressive force and still be able to return to its usage configuration when the compressive force is removed. The flexibility of the composite material makes it possible to inflate the headgear even in low-pressure settings at least 6 cmH2O higher than ambient pressure.

[0105] Headgear tubing can be made from a stretchable material. For this purpose, composite materials are used, with a resistance of approximately 15 N / mm². 2 ~Approx. 150N / mm 2 The headgear tubing may have a Young's modulus of 1.5. The headgear tubing may be more elastic with respect to the second transverse axis along at least a portion of its length.

[0106] Advantageously, the directional or non-uniform stretchability of the headgear tubing allows for a better fit to the patient's head by enabling a wider fit curve without sacrificing the rigidity of the conduit. This can be provided by material properties such as tensile modulus and / or by shaping the material appropriately. For example, a curved shape can be formed that allows the headgear to bend. This stretchability allows the headgear to stretch beyond its original cross-section and / or length, adapting to a variety of head sizes.

[0107] In some embodiments, the Young's modulus of the headgear tubing along the length of the tubing is approximately 15 N / mm². 2 ~Approx. 150N / mm 2 That is the case.

[0108] In some embodiments, the first fabric layer further includes a fastening portion that can be opened to expose the film. The fastening portion is in contact with the headgear tubing along its length. The fastening portion may extend from a first position near the entrance to a second position near the exit.

[0109] The fastening portion, when opened, allows the patient to access the internal cavity of the double-walled film of the headgear tubing. This facilitates cleaning of the cavity, providing the patient with peace of mind regarding the hygiene of the product.

[0110] In some embodiments, the first fabric layer is a mesh fabric layer.

[0111] In some embodiments, the headgear tubing is flat when compressed.

[0112] In some embodiments, the headgear tubing further includes vents. The vents can be positioned near the exit of the headgear.

[0113] Therefore, the patient's exhalation to expel carbon dioxide can be combined with the release of excess pressurized air from the headgear tubing. This can result in better regulation of airflow to the patient's nostrils. Furthermore, the accumulation of carbon dioxide within the headgear tubing can be avoided. By positioning the vents appropriately, it becomes possible to effectively expel CO2 and maintain the therapeutic pressure within the intended limits.

[0114] In some embodiments, the headgear tubing, when inflated, is positioned to conform to the contour of the patient's head.

[0115] In some embodiments, the headgear tubing is 15 N / mm 2 It has a bending modulus of less than .

[0116] In some embodiments, the second fabric layer is annealed to the first fabric layer.

[0117] In some embodiments, the film has a total transmittance of more than 90%.

[0118] In some embodiments, the film is selected from thermoplastic polyurethane.

[0119] In some embodiments, a first fabric layer is laminated to the first side by heat bonding or adhesive bonding. In some embodiments, a second fabric layer is laminated to the second side by heat bonding or adhesive bonding.

[0120] In some embodiments, the first fabric layer has a knitted structure selected from single jersey, rib, interlock, raschel, or jacquard.

[0121] In some embodiments, the second fabric layer is selected from microfiber yarn, nylon 6,6, peach skin finish, elastic knit fabric, bidirectional stretch fabric, non-stretch fabric, circular knit fabric, woven fabric, or warp knit fabric.

[0122] In some embodiments, the second fabric layer is surface-treated with a hydrophobic coating.

[0123] In some embodiments, the composite material further includes a foam sandwiched between a second fabric layer and a second side of a double-wall film.

[0124] The foam acts as a cushion that compresses the patient's head / face when the headgear inflates, improving comfort.

[0125] In some embodiments, the tension structure can be positioned to overlap the posterior region of the patient's head. The tension structure may be elastic.

[0126] The tension structure allows the mask to stretch and fit the patient's head, applying a consistent compressive force. This makes it possible to create a one-size-fits-all design that accommodates all functions.

[0127] One embodiment of this technology relates to a patient interface comprising a headgear disclosed herein and a seal-forming structure integrated into or attachable to the headgear at the exit of the headgear. The seal-forming structure is constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway in order to deliver an airflow at a pressure at least 6 cmH2O higher than ambient air pressure.

[0128] One embodiment of this technology relates to a patient interface comprising a headgear, a plenum chamber, and a seal-forming structure. The headgear includes at least one air inlet, at least one air outlet that can be positioned in fluid communication with the seal-forming structure during use, headgear tubing extending along the length between the air inlet and the air outlet, and a tension structure for providing a force to maintain the seal-forming structure during use. The headgear tubing is expandable from a compressed state to an inflated state, forming a conduit for supplying pressurized air to the patient. The headgear tubing is formed from a composite material and includes a double-walled film having an internal cavity and an outer surface. The outer surface includes a first side and a second side. The film is impermeable to pressurized air. The first fabric layer is connected to the first side, and the second fabric layer is connected to the second side. The headgear tubing has a first transverse axis extending generally laterally along the length of the headgear tubing and a second transverse axis extending generally laterally with respect to the first transverse axis. The headgear tubing is selectively expandable in a first direction along the first transverse axis with respect to a second direction along the second transverse axis. The plenum chamber is fluid-communicated adjacent to the headgear outlet and pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure, and includes a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's respiration. A seal-forming structure is adjacent to the inner surface of the headgear outlet and constructed and positioned to form a seal with the area of ​​the patient's face surrounding the inlet to the patient's airway, having a hole therein to deliver airflow at the therapeutic pressure to at least the inlet to the patient's nostrils, and constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use, wherein the patient interface is configured to allow the patient to breathe through the mouth from the surroundings when there is no pressurized airflow through the inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0129] One embodiment of this technology relates to a patient interface comprising a headgear, a plenum chamber, and a seal-forming structure. The headgear includes at least one air inlet that can be positioned to overlap the upper region of the patient's head in the use position, at least one air outlet that can be positioned in fluid communication with the seal-forming structure when in the use position, headgear tubing extending along the length between the air inlet and the air outlet, and a tension structure that provides force to maintain the seal-forming structure in the use position. The headgear tubing is expandable from a compressed state to an inflated state, forming a conduit for supplying pressurized air to the patient. The headgear tubing is formed from a composite material and includes a double-walled film having an internal cavity and an outer surface. The outer surface includes a first side and a second side. The film is impermeable to pressurized air. The first fabric layer is connected to the first side, and the second fabric layer is connected to the second side. The headgear tubing has a first transverse axis extending generally laterally along its length, and a second transverse axis extending generally laterally relative to the first transverse axis. The headgear tubing is selectively expandable in a first direction along the first transverse axis with respect to a second length along the second transverse axis. The plenum chamber is fluid-communicated adjacent to the headgear outlet and can be pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure, and includes a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's respiration. The seal-forming structure is adjacent to the inner surface of the outlet of the headgear and is constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway and has holes therein to deliver airflow at therapeutic pressure to at least the entrance to the patient's nostrils and is constructed and positioned to maintain therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use, wherein the patient interface is configured to allow the patient to breathe through the mouth from the surroundings when there is no pressurized airflow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth uncovered.

[0130] The patient interface further includes a ventilation structure that allows the gas exhaled by the patient to flow continuously from the inside of the plenum chamber outwards, and is sized and shaped to maintain therapeutic pressure within the plenum chamber during use.

[0131] The headgear and / or patient interface may further include a rigidizer or stiffener to maintain the curved shape of the headgear and / or patient interface during use. The rigidizer may be positioned adjacent to the headgear tubing and bonded to the outer surface of the double-wall film. For example, the rigidizer may be connected to a second side of the outer surface of the double-wall film. In this regard, the rigidizer may be sandwiched between the second side of the outer surface of the double-wall film and a second fabric layer.

[0132] The rigidizer prevents the conduit from collapsing and / or flattening, or at least in a first direction along a first translation axis, and is selectively expandable in a second direction along a second translation axis.

[0133] The rigidizer may include a spine structure that extends at least partially along the headgear and / or patient interface. The rigidizer may also include a number of projections extending from the sides of the spine structure. The projections are spaced apart from each other along the length of the spine structure.

[0134] In the case of a "fishbone" structure, the rigidizer supports the conduit and prevents kink formation. This ensures that the flow of breathable gas or air is not obstructed. Furthermore, a kink-free headgear and / or patient interface provides the user with the sensation of a smooth, comfortable, high-quality finish.

[0135] The rigidizer may further include a collar structure positioned at one end of the spine structure. For example, the collar structure may be a ring surrounding an air inlet. The collar structure may also be a crescent-shaped structure that partially surrounds the air inlet. The collar structure may provide additional support to the area surrounding the air inlet.

[0136] The rigidizer may further include at least one tab. If the rigidizer with the tab is formed together with an expandable conduit, and the tab extends outward from the expandable conduit, the tension structure may be connected to the tab, thus providing additional support between the expandable conduit and the tension structure.

[0137] Another aspect of one form of this technology is a patient interface molded or otherwise constructed together with a peripheral shape that is complementary to the shape of the intended wearer.

[0138] One embodiment of this technology is a method for manufacturing a headgear and / or patient interface.

[0139] One particular aspect of this technology is a medical device that is easy to use for, for example, a person who has not received medical training, a person who is not very dexterous or lacks insight, or a person who has limited experience using this type of medical device.

[0140] One embodiment of this technology is a portable RPT device, including a headgear and / or patient interface, which can be carried by a person, for example, around a person's home.

[0141] One embodiment of this technology is a patient interface that can be cleaned at the patient's home with, for example, soapy water, and does not require any special cleaning equipment. Another embodiment of this technology is a humidifier tank that can be cleaned at the patient's home with, for example, soapy water, and does not require any special cleaning equipment.

[0142] The methods, systems, devices, and apparatus described may be embodied in a way that enables improvements in the functionality of processors (e.g., processors in purpose-specific computers, respiratory monitors, and / or respiratory therapy devices). Furthermore, the methods, systems, devices, and apparatus described may enable improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions (e.g., sleep-disordered breathing).

[0143] Of course, some of the above embodiments may form sub-embodiments of the present technology. Furthermore, various sub-embodiments and / or embodiments can be combined in various ways to constitute further embodiments or sub-embodiments of the present technology.

[0144] Other features of this technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawing]

[0145] 4. Brief Description of the Drawings This technology is illustrated in the attached drawings as a non-limiting embodiment. In the drawings, similar reference numerals include the following similar elements: 4.1 Respiratory Therapy Systems [Figure 1A] The system includes a patient 1000 wearing a patient interface 3000 in the form of a nasal pillow, which receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. A bedmate 1100 is also illustrated. The patient is sleeping in a supine position. [Figure 1B] The system includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask, which receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. [Figure 1C]The system includes a patient 1000 wearing a patient interface 3000 in the form of a full-face mask, which receives positive pressure air from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. The patient is sleeping in a lateral sleeping position. 4.2 Anatomy of the respiratory system and face [Figure 2A] This diagram outlines the human respiratory system, including the nasal cavity and oral cavity, larynx, vocal cord folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] This is a diagram of the human upper respiratory tract, including the nasal cavity, nasal bones, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cord folds, esophagus, and trachea. [Figure 2C] This is a frontal view of the face including several features of surface anatomical structures, including the upper lip, upper lip robe, lower lip robe, lower lip, width of the mouth, medial canthus, nasal wings, nasolabial folds, and corners of the mouth. The superior, inferior, radially medial, and radially lateral directions are also indicated. [Figure 2D] This is a lateral view of the head, including several features of surface anatomical structures, such as the glabella, therion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, apex of the nasal ala, superior base of the ear, and inferior base of the ear. Superior and inferior, as well as anterior and posterior directions, are also described. [Figure 2E] This is a further lateral view of the head. The approximate positions of the Frankforth horizontal and nasolabial angles are indicated. The coronal plane is also shown. [Figure 2F] This is a pedicle view of the nose, including several features such as the nasolabial folds, lower lip, upper lip red, nostrils, subnasal point, columella, nasal tip, main axis of the nostrils, and the median sagittal plane. [Figure 2G] This is a lateral view of the surface features of the nose. [Figure 2H] This shows the subcutaneous structure of the nose, including the lateral nasal cartilage, nasal septal cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibrous adipose tissue. [Figure 2I]This shows a mid-nasal incision located a few millimeters from the midline sagittal plane, particularly the medial crura of the nasal septum cartilage and the greater alar cartilage. [Figure 2J] This is a frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae are shown together with the maxilla and mandible. [Figure 2K] This is a lateral view of the skull showing the external shape of the head surface and several muscles. The following bones are illustrated: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is illustrated. The following muscles are illustrated: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle. [Figure 2L] This shows the anterolateral aspect of the nose. 4.3 Patient Interface [Figure 3A] This shows a patient interface in the form of a nasal mask, which is one embodiment of this technology. [Figure 3B] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively large compared to the curvature shown in Figure 3C. [Figure 3C] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively small compared to the magnitude of curvature shown in Figure 3B. [Figure 3D] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature value at this point is zero. [Figure 3E] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively small compared to the magnitude of curvature shown in Figure 3F. [Figure 3F] This is a schematic cross-sectional view of the structure cut at point 1. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively large compared to the curvature shown in Figure 3E. [Figure 3G]A mask cushion containing two pillows is shown. The outer surface of the cushion is illustrated. The edges of the surface are illustrated. The dome region and saddle region are illustrated. [Figure 3H] A mask cushion is shown. The outer surface of the cushion is illustrated. The edges of the surface are illustrated. The path on the surface between point A and point B is illustrated. The straight-line distance between A and B is illustrated. Two saddle-shaped regions and a dome-shaped region are illustrated. [Figure 3I] The surface of the structure is shown, and one-dimensional holes are present within this surface. The planar curves in the illustration form the boundaries of the one-dimensional holes. [Figure 3J] This is a cross-sectional view through the structure in Figure 3I. The illustrated surface defines the two-dimensional hole in the structure in Figure 3I. [Figure 3K] Figure 3I is a perspective view of the structure including two-dimensional and one-dimensional holes. The surfaces that define the two-dimensional holes in the structure of Figure 3I are also shown. [Figure 3L] This shows a mask with an expandable bladder that acts as a cushion. [Figure 3M] Figure 3L is a cross-sectional view of the mask, showing the inner surface of the bladder. The inner surface defines the two-dimensional holes within the mask. [Figure 3N] Figure 3L shows a further cross-section through the mask. The inner surface is also illustrated. [Figure 3O] This demonstrates the left-hand rule. [Figure 3P] I will demonstrate the right-hand rule. [Figure 3Q] Shows the left ear, including the left ear spiral. [Figure 3R] Shows the right ear, including the right ear spiral. [Figure 3S] The right hand demonstrates a spiral. [Figure 3T] This is a diagram of a mask that includes a sign of the twist of the spatial curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] This is a diagram of the plenum chamber 3200, showing the sagittal plane and the central contact surface. [Figure 3V]Figure 3U is a rear view of the plenum chamber. The directions in the figure are perpendicular to the central contact surface. In Figure 3V, the sagittal plane divides the plenum chamber into left-hand and right-hand sides. [Figure 3W] Figure 3V is a cross-sectional view through the plenum chamber, taken in the sagittal plane shown in Figure 3V. The "central contact" surface is illustrated. The central contact surface is perpendicular to the sagittal plane. The orientation of the central contact surface corresponds to the orientation of tendon 3210. Tendon 3210 rests on the sagittal plane and contacts the cushion of the plenum chamber only at two points on the sagittal plane, the upper point 3220 and the lower point 3230. Depending on the geometry of the cushion in this region, the central contact surface may contact both the upper and lower points. [Figure 3X] Figure 3U shows the plenum chamber 3200 in the position for use on the face. The sagittal plane of the plenum chamber 3200 generally coincides with the midline sagittal plane of the face when the plenum chamber is in the position for use. The central contact surface generally corresponds to the "face plane" when the plenum chamber is in the position for use. In Figure 3X, the plenum chamber 3200 is part of a nasal mask, with the upper point 3220 resting approximately on the serion and the lower point 3230 resting on the upper lip. [Figure 3Y] This shows a patient interface in the form of a nasal cannula, one embodiment of this technology. 4.4 RPT Device [Figure 4A] This shows an RPT device based on one form of this technology. [Figure 4B] This is a schematic diagram of the pneumatic path of an RPT device according to one embodiment of this technology. The upstream and downstream directions are indicated with respect to the blower and the patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items placed in the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. 4.5 Humidifier [Figure 5A] An isometric view of a humidifier based on one embodiment of this technology is shown. [Figure 5B]An isometric view of a humidifier according to one embodiment of this technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. 4.6 Respiratory waveform [Figure 6A] This shows a model of a typical human respiratory waveform during sleep. 4.7 Screening, diagnostic, and monitoring systems [Figure 7A] This image shows a patient undergoing polysomnography (PSG). The patient is sleeping in a supine position. [Figure 7B] A monitoring device for monitoring the patient's condition is shown. The patient is sleeping in a supine sleeping position. 4.8 Specific examples of current technology [Figure 8A] This is a front perspective view of a patient interface 8000 according to an example of this technology while being worn by patient 1000. [Figure 8B] Figure 8A is a right side view of the patient interface 8000. [Figure 8C] Figure 8A is a right side view of the patient interface 8000. [Figure 8D] This shows some examples of headgear tubing for a patient interface in a collapsed state. [Figure 8E] Figure 8D shows the headgear tubing in its inflated state. [Figure 8F] This is a schematic diagram of the airflow from the headgear tubing to the plenum chamber of the patient interface, and from the plenum chamber. [Figure 9A] This is a front perspective view of a patient interface 9000 according to an example of this technology, while being worn by patient 1000. [Figure 9B] Figure 9A is a left side view of the patient interface. [Figure 9C] Figures 9A and 9B show portions of the headgear tubing for the patient interface. [Figure 9D] Figure 9A is a rear perspective view of the seal-forming structure connected to the headgear tubing of the patient interface. [Figure 9E]This is an example of a plenum chamber adapted for the seal-forming structure of a patient interface. [Figure 9F] This is a perspective view showing a cross-section of a headgear tubing in a crushed state. [Figure 9G] Figure 9F shows the headgear tubing in its inflated state. [Figure 9H] Figure 9G is a further diagram of the headgear tubing, showing the axes by which the physical properties of the headgear tubing can be defined. [Figure 10A] This is a right-side view of an example of a patient interface headgear. [Figure 10B] Figure 10A shows an example of the fastening portion of the headgear tubing of the patient interface in the closed state. [Figure 10C] Figure 10B shows an example of the fastening portion of the headgear tubing in its open state. [Figure 11A] This is a front perspective view of another embodiment of the patient interface for patient use. [Figure 11B] Figure 11A is a front view of the embodiment shown. [Figure 11C] Figure 11A is a magnified view of the front portion of the patient interface. [Figure 11D] Figure 11A is a top perspective view of the upper portion of the patient interface. [Figure 11E] This is a front perspective view of another embodiment of the patient interface for patient use. [Figure 12] This is a front view of another embodiment of the patient interface. [Figure 13A] This is a schematic cross-sectional view of an embodiment of headgear tubing. [Figure 13B] This is a schematic cross-sectional view of another embodiment of the headgear tubing. [Figure 13C] This is a schematic cross-sectional view of a further embodiment of the headgear tubing. [Figure 14A] This is a front view of an embodiment of a headgear without a rigidizer. [Figure 14B]This is a front view of an embodiment of a headgear equipped with a rigidizer. [Figure 15A] This is an exploded view of an embodiment of the headgear. [Figure 15B] An example of a rigidizer on a double-walled film of headgear tubing is shown. [Figure 15C] Another example of a rigidizer on a double-walled film of headgear tubing is shown. [Figure 16A] This is an exploded view of another embodiment of the headgear. [Figure 16B] An example of a retarder on a fabric layer is shown. [Figure 16C] Another example of a rigidizer on a fabric layer is shown. [Figure 17] Further examples of retarders on fabric layers are shown. [Figure 18A] Another example of a rigidizer on a double-walled film is shown. [Figure 18B] Here is another example of a retarder. [Figure 18C] This is a top view of an embodiment of a headgear equipped with a rigidizer. [Figure 19] Figure 16B is an enlarged view of the rigidizer, showing the spine structure and details of the protrusions. [Figure 20A] Further examples of rigidizers having opposing protrusions are shown. [Figure 20B] Further examples of rigidizers having alternating protrusions are shown. [Figure 20C] Further examples of rigidizers formed from rigid and elastomer materials are shown. [Figure 20D] Further examples of rigidizers having expandable portions formed by the first configuration are shown. [Figure 20D-1] Further examples of rigidizers having expandable portions formed by the second configuration are shown. [Figure 20D-2] Further examples of rigidizers having expandable portions formed by a third configuration are shown. [Figure 21] This shows an example of where the rigidizer is positioned within the headgear tubing. [Figure 22] Examples of air path patterns that can be formed within an expandable bladder and / or seal-forming structure are shown. [Figure 23A] A front view of an embodiment of a plenum chamber having ribs is shown. [Figure 23B] A side view of an embodiment of a plenum chamber having ribs is shown. [Modes for carrying out the invention]

[0146] 5. Detailed description of embodiments of this technology Before describing the technology in further detail, it should be understood that the technology is not limited to the specific embodiments which may differ as described herein. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0147] The following description is provided in relation to a variety of embodiments that may share one or more common properties and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or any other embodiment. In addition, any single feature or combination of features in any of these embodiments may constitute a further embodiment. 5.1 Treatment

[0148] In one embodiment, the technology includes a method for treating respiratory diseases, which involves applying positive pressure to the airway entrance of 1000 patients.

[0149] In one embodiment, the technology includes a method for screening respiratory diseases, which includes applying positive pressure to the airway entrance of 1000 patients. In one embodiment, the technology includes a method for diagnosing respiratory diseases, which includes applying positive pressure to the airway entrance of 1000 patients. In one embodiment, the technology includes a method for monitoring respiratory diseases, which includes applying positive pressure to the airway entrance of 1000 patients. In one embodiment, the technology includes a method for improving respiratory diseases, which includes applying positive pressure to the airway entrance of 1000 patients. In one embodiment, the technology includes a method for preventing respiratory diseases, which includes applying positive pressure to the airway entrance of 1000 patients.

[0150] The applied positive pressure may be supplied to the headgear and / or patient interface disclosed herein via a high-pressure source and / or oxygen source.

[0151] In one embodiment, the technology provides a device used for screening respiratory diseases. In one embodiment, the technology provides a device used for diagnosing respiratory diseases. In one embodiment, the technology provides a device used for monitoring respiratory diseases. In one embodiment, the technology provides a device used for improving respiratory diseases. In one embodiment, the technology provides a device used for treating respiratory diseases. In one embodiment, the technology provides a device used for preventing respiratory diseases.

[0152] The device may be a medical device that includes a headgear and / or patient interface as disclosed herein.

[0153] Respiratory diseases include, but are not limited to, obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall diseases.

[0154] In certain embodiments of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0155] In certain embodiments of this technology, mouth breathing is restricted, limited, or prevented. 5.2 Respiratory Therapy Systems

[0156] In one embodiment, the technology includes a respiratory therapy system for the treatment of respiratory diseases. The respiratory therapy system may include an RPT device 4000 that supplies airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800. 5.3 Patient Interface

[0157] A non-invasive patient interface 3000 according to one aspect of this technology includes the following functional aspects: a seal-forming structure 3100 and a headgear disclosed herein. The headgear includes a tension structure 3300. The headgear is suitable for delivering a supply of pressurized breathable gas to the entrance of the patient's airway.

[0158] Other embodiments of the patient interface of this technology are also shown in Figures 8, 9, 10, 11, 12, and 14. Using Figures 8A and 8B as an example, the patient interface 8000 includes a headgear 8010 and a seal-forming structure (hidden). The headgear 8010 includes a headgear tubing 8060 and a tension structure 8020. The headgear tubing 8060 provides a flow of pressurized air from the headgear inlet 8040 to the headgear outlet 8030. The inlet 8040 is connected to an air delivery tube 4170 for pressurized air to flow into the headgear tubing 8060. The outlet 8030 can be positioned adjacent to the patient's nostrils and / or mouth when in use. The flow of compressed air is indicated by the arrows in Figure 8B. The pressurized air is directed outward from the outlet 8030 via the airflow 8110. The tension structure 8020 can be connected to the headgear tubing 8060 at any position as long as it provides tension to secure the headgear to the patient's head. The tension structure 8020 can also be integrated with the headgear tubing 8060. As shown in this embodiment, the tension structure 8020 is connected in a proximal position along the headgear tubing 8060. In this embodiment, the tension structure 8020 is positioned to pass above the upper base of the ear (above the ear) on the patient's head when in use.

[0159] Figure 8B shows the air inlet 8040 positioned across the upper region of the patient's head during use. The upper region refers to the cranial region of the head, proximal to the brain. Alternatively, the air inlet 8040 can be positioned at any location along the length of the headgear tubing 8060. For example, the air inlet 8040 can be positioned on the side of the patient's head.

[0160] Figure 8C shows a right side view of the headgear tubing 8060. The inner layer 8070, which comes into contact with the patient's head during use, is exposed. The inner layer 8070 may be made of fabric to provide comfort to the patient. As shown, the outer layer may be constructed from a fabric layer, so that the entire headgear tubing 8060 is constructed from layer 8070, although in other examples only.

[0161] The embodiment shown in Figure 9A is a patient interface 9000 including a headgear 9010, a concealed plenum chamber 9110, and a seal-forming structure 9090. The plenum chamber 9110 is enclosed within the headgear adjacent to the outlet 9030. In this embodiment, the plenum chamber 9110 is generally not visible after the patient interface has been worn by the patient. The plenum chamber 9110 can be pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure. As shown in Figure 9E, the plenum chamber includes a plenum chamber inlet port 9112, which is sized and constructed to receive an airflow at the therapeutic pressure for the patient to breathe. The plenum chamber inlet port 9112 may be connected to the end of the headgear tubing. The seal-forming structure 9090 is positioned on the inner surface 9070 of the headgear adjacent to the outlet 9030, constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, and has holes to deliver airflow at therapeutic pressure to at least the entrance to the patient's nostrils, and is constructed and positioned to maintain therapeutic pressure in the plenum chamber 9110 throughout the patient's entire respiratory cycle in use. The patient interface is configured to allow the patient to breathe from the surroundings through their mouth when there is no pressurized airflow through the plenum chamber inlet port. Alternatively, the patient interface may be configured to leave the patient's mouth uncovered.

[0162] As mentioned, the patient interface 9000 may further include a plenum chamber inlet port 9112 that allows for a continuous flow of pressurized air from the end of the headgear tubing to the plenum chamber 9110. Thus, the patient may inhale the pressurized air in the plenum chamber 9110, at least through the nostrils. The plenum chamber may be designed to be of any size or shape and, in some examples, may be wrapped together with the headgear tubing by fabric (also referred to herein as fiber) or other material.

[0163] The air inlet 9040 is displaced laterally above the headgear tubing 9060. The air inlet 9040 is further cased to protect the connection between the pneumatic tube and the air inlet from crushing during patient use. The tension structure 9020 expands at one end to connect integrally with substantially the entire length of the headgear tubing 9060. When formed in this manner, the tension structure substantially covers the patient's ears and provides a muffler function against noise disturbance.

[0164] Another embodiment of the patient interface 10000 is shown in Figures 10A–10C. The patient interface 10000 includes a headgear 10010. A tension structure 10030 is positioned at the distal end of the headgear tubing, aligned in a line adjacent to the outlet 10050. In addition, a retention structure 10040 may be present to provide additional tension in the form of additional support and stabilization. The retention structure 10040 may be connected to substantially the entire length of the headgear tubing 10010 and may be connected to further positions along the headgear tubing away from the tension structure 10030. The retention structure 10040 may be integrated with the headgear tubing and tension structure 10040 so as to substantially cover the base of the ear of the patient's head (including the ear).

[0165] Figures 11A and 11B show another embodiment of the patient interface 11000. The patient interface 11000 includes a headgear 11010 and a seal-forming structure 11100. Similar to Figure 8, the headgear 11010 includes a tension structure 11020 which, when in use, is positioned to pass above the upper earlobe point (above the ear) of the patient's head.

[0166] Figure 12 shows another embodiment of the patient interface 12000. The patient interface 12000 includes a headgear 12010 and a seal-forming structure 12100. An orifice 12030 is also shown from which a plenum chamber (not shown) may be attached. If attached, the plenum chamber is fluid-connected to the outlet but is located outside the headgear. An air supply tubing 4170 can be connected at one end to the inlet (concealed) of the headgear, and the other end of the tubing may be connected to a high-pressure air source and / or an oxygen source. A tension structure 12020 and a retention structure 12040 are connected to and integrated with the headgear tubing to substantially cover the base-of-the-ear region of the patient's head (excluding the ears).

[0167] In its configuration of use (or during use), the patient interface forms a web that covers the patient's head or face. The passage of pressurized air from the air inlet expands or inflates the conduits within the headgear tubing of the headgear. When filled with air, the headgear tubing takes on a three-dimensional shape that substantially conforms to the contour of the patient's head. Air from the inlet passes through the headgear tubing and enters the patient's nostrils and / or mouth from the outlet. In the collapsed configuration, the headgear tubing contracts or the air is substantially emptied. In this configuration, the headgear is elastically deformable and can be rolled up and / or folded for packaging / storage.

[0168] Another form of the non-invasive patient interface 3000 includes a seal-forming structure 3100, a plenum chamber 3200, a tension structure 3300, a vent 3400, a form of a connection port 3600 for connecting to an air circuit 4170, and a forehead support 3700. In use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airway so as to maintain positive pressure at the entrance to the patient's airway 1000. Thus, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy.

[0169] If a patient interface cannot comfortably deliver the minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0170] A patient interface 3000 in one form of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 6 cmH2O relative to the surroundings.

[0171] A patient interface 3000 in one embodiment of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 10 cmH2O relative to the surroundings.

[0172] A patient interface 3000 in one form of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 20 cmH2O relative to the surroundings. 5.3.1 Seal-forming structure

[0173] In one embodiment of this technology, the seal-forming structure 3100 may provide a target seal-forming region and further provide a cushioning function. The target seal-forming region is the region in the seal-forming structure 3100 where sealing can occur. The region where sealing actually occurs (i.e., the actual sealed surface) may vary from patient to patient in a given treatment session, depending on a range of factors (e.g., the placement of the patient interface on the face, the tension in the tension structure, and the shape of the patient's face).

[0174] For example, the seal-forming structure may cover at least one of the patient's nostrils, or at least one of the patient's nostrils and / or mouth.

[0175] In one embodiment, the target seal-forming region is located on the outer surface of the seal-forming structure 3100.

[0176] In a particular form of this technology, the seal-forming structure 3100 is constructed from a biocompatible material (e.g., silicone rubber).

[0177] The seal-forming structure 3100 according to this technology may be composed of a soft, flexible, and elastic material (e.g., silicone). For example, Figure 8F shows a seal-forming structure 8100 and Figure 9A shows a seal-forming structure 9090, both of which may be formed from silicone. In other embodiments, the seal-forming structure is constructed from a foamed material. For example, Figure 11C shows a seal-forming structure 11100 constructed from a foamed material. Figure 12 also shows a patient interface including a headgear and a seal-forming structure 12100 constructed from a foamed material. In yet another example, the seal-forming structure may be constructed from a fibrous material.

[0178] The seal-forming structure may be removable from the exit of the headgear. This allows the patient to clean the seal-forming structure to maintain hygiene and replace it as needed.

[0179] In certain embodiments of this technology, a system is provided comprising more than one seal-forming structure 3100, each seal-forming structure 3100 configured to accommodate different size and / or shape ranges. For example, the system may include one form of seal-forming structure 3100 suitable for large heads rather than small heads, and another suitable for small heads rather than large heads.

[0180] The seal-forming structure can be integrated with the headgear at its outlet. In this regard, the seal-forming structure and the headgear are supplied as a single product. The seal-forming structure can be constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway in order to deliver airflow at a pressure at least 6 cmH2O higher than ambient air pressure. Alternatively, the seal-forming structure can be attached to the headgear at the headgear's outlet. Thus, the patient can purchase or replace these parts individually as needed. 5.3.1.1 Sealing mechanism

[0181] In one embodiment, the seal-forming structure includes a sealing flange using a pressure-assisted sealing mechanism. During use, the sealing flange can readily respond to the positive system pressure within the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism may work in conjunction with the elastic tension in the tension structure.

[0182] In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than approximately 1 mm (e.g., approximately 0.25 mm to approximately 0.45 mm). This member extends around the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is positioned between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of its peripheral length. The support flange is or includes a spring-like element and functions to support the sealing flange so as not to buckle during use.

[0183] In one embodiment, the seal-forming structure may include a compression sealing portion or a gasket sealing portion. During use, the compression sealing portion or gasket sealing portion is constructed and positioned such that it is compressed, for example, due to elastic tension in a tension structure.

[0184] In one embodiment, the seal-forming structure includes a tensioning portion. During use, the tensioning portion is held taut by, for example, an adjacent region of the sealing flange.

[0185] In one embodiment, the seal-forming structure includes a region having an adhesive surface or bonding surface.

[0186] In certain embodiments of this technology, the seal-forming structure may include one or more of the following: a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or bonding surface.

[0187] Figure 9D shows an example of a seal-forming structure 9090 having a sealing mechanism. The seal-forming structure 9090 includes a seal flange 9100 extending around the seal-forming structure 9090.

[0188] The seal-forming structure may be an inflatable seal-forming structure. The inflatable or ballooning seal type is a type of seal in which, during use, the system pressure or airflow delivered to the seal-forming structure acts to press a flange, skirt, or other similar member extending inward against the patient's face, thereby forming a substantial seal. Thus, the inflatable or ballooning seal type differs from seal types that rely solely on interface-holding force from the headgear to press or deform the cushion against the patient's face with sufficient force to seal the cushion against the features of the patient's face. To provide a suitable inflatable or ballooning effect, the seal-forming structure may include a flexible, compliant sealing member adapted to cover the patient's nostrils and / or mouth. The sealing member may include a periphery and a sealing flange extending inward from the periphery. Preferably, the sealing flange extends inward from all or substantially all of the periphery. At least a portion of the sealing flange forms a sealing portion that contacts the patient's face. The seal-forming structure is also adapted to communicate with an air inlet and fluid. During use, the seal-forming structure is washed away by air from the air inlet, and the seal portion comes into contact with the patient's face. Under the internal pressure of the inflated seal and the holding pressure of the headgear, the seal portion is pressed against the patient's face, creating an effective seal on the inside of the periphery. The inflatable seal-forming structure works to minimize the pressure on the patient's face, distribute the pressure, and reduce the likelihood of excessive localized pressure distribution.

[0189] The expandable seal-forming structure can be curved to conform to the contours of the patient's face, extending around the patient's nose and substantially enveloping it. The seal-forming structure may extend fully across the sides of the patient's nose, or at least partially across the patient's cheeks.

[0190] Such an inflatable seal-forming structure can be formed from silicone having a Shore A hardness of about 40. Other materials having similar properties may also be used. 5.3.1.2 Nasal bridge or nasal sill region

[0191] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the nasal bridge region or nasal sill region of the patient's face during use.

[0192] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over the nasal bridge region or nasal sill region of the patient's face during use. 5.3.1.3 Upper lip region

[0193] In one form, the non-invasive patient interface includes a seal-forming structure that forms a seal over the upper lip region (i.e., the upper lip) of the patient's face during use.

[0194] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over the upper lip region of the patient's face during use. 5.3.1.4 Jaw region

[0195] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the jaw region of the patient's face during use.

[0196] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over the jaw region of the patient's face during use. 5.3.1.5 Forehead region

[0197] In one form, the seal-forming structure forms a seal over the forehead region of the patient's face during use. In such a form, the plenum chamber may cover the eyes during use. 5.3.1.6 Nasal pillows

[0198] In one embodiment, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows. Each nasal puff or nasal pillow is constructed and positioned to form a seal with each nostril of the patient's nose.

[0199] A nasal pillow according to one aspect of this technology includes a frustum of a cone. At least a portion of the frustum of the cone forms a seal on the underside of the patient's nose, on the stalk, and on a flexible region on the underside of the frustum of the cone, connecting the frustum of the cone to the stalk. In addition, the structure to which the nasal pillow of this technology is connected includes a flexible region adjacent to the base of the stalk. The flexible region may function to facilitate a flexible connection structure. The flexible connection structure accommodates both the displacement and angle of the frustum of the cone and the mutual movement between the nasal pillow and the structure to which it is connected. For example, the frustum of the cone may be displaced axially toward the structure to which the stalk is connected. 5.3.2 Plenum Chamber

[0200] The plenum chamber 3200 has edges shaped to be complementary to the surface contour of an average human face in the area where a seal is formed during use. During use, the periphery of the plenum chamber 3200 is positioned close to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire periphery of the plenum chamber 3200 during use. In some embodiments, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material.

[0201] In certain forms of this technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. Such forms tend to be less cumbersome and / or more comfortable for the wearer, which may improve compliance with treatment.

[0202] In certain forms of this technology, the plenum chamber 3200 is constructed from a transparent material, such as transparent polycarbonate. The use of transparent materials can reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of transparent materials may also help clinicians confirm the placement and function of the patient interface.

[0203] In a specific form of this technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the visual intrusiveness of the patient interface, thereby aiding in improved compliance with treatment.

[0204] Figure 9E shows a plenum chamber 9110 that can be attached to the patient interface 9000. The plenum chamber 9110 is fluid-communicated and positionable adjacent to the exit of the headgear. The plenum chamber 9110 may be made of a transparent or translucent material.

[0205] Figure 12 shows an orifice 12030 from which a plenum chamber (not shown) may be fitted. As disclosed herein, the plenum chamber may include a vent to facilitate the discharge of carbon dioxide and excess pressurized air.

[0206] As described above, the plenum chamber may be provided with an expandable seal-forming structure. When silicone is used as the material for the expandable seal-forming structure, the resulting silicone cushion tends to be less stable, and the rigid plastic frame structure of the plenum chamber is still in contact with the patient's cheek. Furthermore, because the rigid plastic frame structure is relatively heavy, the seal is prone to disruption. Alternatively, a plenum chamber may be used with a frame structure that is soft and flexible yet provides sufficient structural support.

[0207] The plenum chamber 23000 may be provided with a frame 23010 and an inflatable bladder 23020, as shown in Figures 23A and 23B. The inflatable bladder 23020 may be adapted to connect with an inflatable seal-forming structure 23030, or may be formed integrally with the inflatable seal-forming structure 23030. For example, the plenum chamber may include magnetic means for cooperatively engaging with corresponding magnetic means in the inflatable seal-forming structure. The frame 23010 may be a skeletal frame that follows the contour of the plenum chamber 23000. For example, the frame 23010 may include at least two or at least three ribs extending radially from a centrally located valve socket 23040. This skeletal structure provides sufficient rigidity to the seal-forming structure 23030 and the inflatable bladder 23020 without using a substantial amount of rigid components.

[0208] An inflatable bladder can be made of a non-porous fabric or silicone that is not permeable to air. In this way, the bladder can take in air supplied directly from a flow generator and inflate or expand.

[0209] When an inflatable bladder is inflated using air from a flow generator, the bladder is adapted to inflate with uniform and radially distributed pressure. Air delivery to the inflatable bladder can be initiated in "setup mode." The passage for supplying air from the flow generator can be concealed from view by being additionally integrated into the headgear or plenum chamber. Alternatively, an external pump (both manual and automatic) can be connected to the plenum chamber during initial setup to pump the inflatable bladder for use. An opening can be integrated into the plenum chamber to accommodate the external pump.

[0210] The air in the bladder can be retained by stopping or at least slowing down the outflow airflow using at least one-way valves. The one-way valves can be adapted within the valve socket 23040 of the frame 23010. This ensures that the treatment pressure is not affected after the initial pumping. Another one-way valve for releasing air from the plenum chamber may be added to the plenum chamber to further regulate the pressure within the plenum chamber.

[0211] The connection of the one-way valve to the frame can be reinforced using an elbow ring 23050. The elbow ring 23050 may include a connection means for reversibly mounting the one-way valve. This allows the one-way valve to be removed and replaced as needed.

[0212] The air supplied from the device is used at high pressure and, through a one-way valve, allows pressure to build up in the designed air path, helping to support the cushion / conduit and providing both support and structure.

[0213] Silicone materials can be used to form the plenum chamber and seal-forming structure. Alternatively, cloth materials can be used. To further improve the air-holding capacity of the bladder, the material used to form the bladder may be double-layered.

[0214] The air passages within the expandable bladder 23020 and / or the seal-forming structure 23030 can take on different shapes and patterns to provide the desired functionality. For example, not only can they simply provide support, but as long as the path is continuous for air to flow, they can provide movement to the cushion / conduit to serve necessary design intentions, such as extension, torsion, winding up, etc., and the entire plenum chamber and / or seal-forming structure can be inflated. The pattern determines how the structure inflates. Some examples of the patterns are shown in FIG. 22. These patterns provide selective rigidity and flexibility to the plenum chamber and / or seal-forming structure. Additionally, the pattern helps to reduce the amount of air necessary to fill the structure as opposed to having rectangular pockets for air to flow through. This reduces the time until the plenum chamber "deploys".

[0215] After air is pumped in, various patterns can also be used to provide a 3D configuration. Using a pattern, the plenum chamber can be contracted to maintain a substantially flat configuration for transportation and pumped up to adopt a 3D configuration during use. This enables a plenum chamber that is compact, portable, and easy for the patient to store and carry.

[0216] Various patterns of air structures can serve different purposes depending on the design intent and the location of the structure within the patient interface. For example, as shown in Figure 22, a ladder shape allows for increased flexibility along the lateral direction but less flexibility in the vertical direction. This shape can provide a flat surface when pumped up, or a curved surface if the plenum chamber has a pre-formed shape. A ladder shape can be less elastic than a zigzag shape. A zigzag shape can provide flexibility and elasticity in the lateral direction, as well as some flexibility in the vertical direction. A zigzag shape allows the plenum chamber to round into a cylindrical shape when pumped, and the plenum chamber can become semi-conical when pumped, but can be compressed flat when the air is removed. Honeycomb or polygonal patterns can be useful for providing a uniform pressure distribution within the air structure. Therefore, each of these can be useful in conical / component shapes. A square wave pattern can give the plenum chamber a slight curvature. Therefore, the expandable bladder of the plenum chamber may include a combination of patterns adapted to provide a 3D configuration suitable for use.

[0217] To form air channels (which may be winding / twisted) within the expandable bladder 23020, the bladder may be manufactured, for example, by bonding or welding together separate fabric or silicone layers. For example, when applied to an air-retaining fabric mask (such as a silicone-coated fabric or TPU-lined fabric mask), the layers may be bonded / welded in a selective manner to create air channels.

[0218] The frame of the plenum chamber may include radial ribs 23060. Figures 23A and 23B show examples of the frame of the plenum chamber in a front view and a side view, respectively. The plenum chamber may be adapted to a centrally located one-way valve (not shown) having at least three ribs 23060 extending radially from the one-way valve. The distal ends of the ribs are adjacent to a seal-forming structure 23030. This provides some support to prevent the plenum chamber from collapsing over the patient's nostrils and / or mouth in the event of a pressure drop within the bladder.

[0219] The plenum chamber may include means for attachment to the headgear. The means may be tabs or loops configured to fit the corresponding means on the headgear. Magnets may also be used. 5.3.3 Headgear

[0220] The headgear of this technology can be held in a sealed position during use, at least by headgear tubing.

[0221] In one form, the headgear provides at least sufficient holding force to overcome the effects of positive pressure in the plenum chamber and lift it away from the face.

[0222] In one form, the headgear provides a holding force to overcome the effects of gravity on the patient interface.

[0223] In one configuration, the headgear provides a holding force that serves as a safety margin to eliminate the possibility of destructive effects on the patient interface, such as those caused by tube dragging or accidental interference with the patient interface.

[0224] In one embodiment of this technology, a headgear is provided that is configured to be worn by a patient while sleeping. In one embodiment, the headgear has a low profile or cross-sectional thickness to reduce the perceived bulk or actual bulk of the device.

[0225] In one embodiment of this technology, a headgear is provided that is not too large or bulky in order to prevent the patient from lying in a supine sleeping position with their head on a pillow.

[0226] In one embodiment of this technology, a headgear is provided that is not too large or bulky in order to prevent a patient from lying on their side in a sleeping position with their head resting on a pillow.

[0227] Referring to Figures 8A–8F, in a particular embodiment of the art, the headgear 8010 includes at least one air inlet 8040 and at least one air outlet 8030. The inlet 8040 and outlet 8030 allow airflow from inlet to outlet via the headgear tubing 8060 (as indicated by the arrows). The inlet 8040 is positionable to substantially overlap the upper region of the patient's head in the use position. As shown in Figure 2C, the upper region of the patient's head refers to the cranial region of the head, proximal to the brain. This region may include the forehead and scalp. The inlet 8040 may be substantially in the sagittal plane or adjacent to the sagittal plane. The inlet 8040 may also be positioned offset from the sagittal plane and overlap the upper region. The outlet 8030 is positionable adjacent to at least one of the patient's nostrils when in the use position. Alternatively, the outlet 8030 may be positioned adjacent to the patient's mouth. The flow of pressurized air to the inlet 8040 may be provided via piping 8050, with a high-pressure air source attached to the other end of piping 8050.

[0228] It should be noted that an oxygen source can also be attached to the inlet 8040 via tubing 4170 (together with or separately from the air source). Therefore, oxygen therapy is provided by attaching the oxygen source.

[0229] A headgear tubing 8060 extends between the inlet 8040 and the outlet 8030. The headgear tubing 8060 is positionable to overlap the lateral region of the patient's head. The headgear tubing 8060 is positionable to substantially align along the coronal plane in the position of use. The conduit of the headgear tubing 8060 or the airflow from the air inlet 8040 to the outlet 8030 within the tubing 8050 is indicated by arrows in Figure 8B. Figures 8D and 8E show the conduit 8050 that can be formed within the headgear tubing 8060. The conduit 8050 is provided by a cavity within a double-walled film. In this example, the double-walled film is formed by two separate films (8080 and 8090) joined or sewn together at the ends. The ends may be further reinforced with seam tape 8120 to improve the seal and obtain structural integrity. The double-walled film may have fibers laminated on one or both sides facing outward. In a resting or unused state, the conduit 8050 of the headgear tubing 8060 is not filled with pressurized air and is in a collapsed state (Figure 8D). During use, the conduit 8050 of the headgear tubing 8060 is at least partially flushed or filled with pressurized air and is in an expanded or inflated state (Figure 8E). The headgear tubing 8060 can transition between an inflated and collapsed state by using the conduit (or cavity) to supply pressurized air from the air inlet to the patient's nostrils and / or mouth. Thus, during use, the conduit 8050 within the headgear tubing 8060 is durable enough to withstand pressurized air of at least 6 cmH2O and has sufficient width and / or thickness to deliver a constant and sufficient flow of pressurized air from the air inlet to the patient. In addition to the advantages gained by relocating the air inlet from the position of the "elephant tank," there is the further advantage that the inflated headgear tubing avoids the pressure on the patient's head that is commonly seen in patient interfaces with elastic straps. In either configuration, the headgear tubing 8060 can be positioned adjacent to or close to the patient's head during use.When the headgear tubing is compressed and not in use, it is elastically deformable and can fold on its own (i.e., scrunchable).

[0230] The headgear 8010 may include a headgear tubing 8060 that widens at the front of the headgear 8010 to "cuddle" the plenum chamber. This provides better fluid communication from the air outlet to the patient's nostrils in that the connection between the air outlet and the plenum chamber does not easily come loose during movement in use. The wider conduit also facilitates ventilation for the patient. The widening of the conduit is also more comfortable for the patient as it reduces pressure in the patient's nostrils and / or mouth. It also provides a more visually appealing headgear. The headgear 8010 also includes a tension structure 8020 to provide additional force to hold the outlet 8030 in use position. The tension structure 8020 may be connected to the headgear tubing 8060 at any point along the length of the headgear tubing 8060, as long as it provides additional retaining force.

[0231] The headgear tubing 8060 may be formed from a composite material. The composite material may include a fabric inner layer 8070 that may be adjacent to or in contact with the patient's head during use. The composite material may further include double-walled films (8080 and 8090) as shown in Figures 8D and 8E. The composite material will be described further below.

[0232] Another example of the headgear tubing 9060 is shown in Figures 9A, 9F, and 9G. The composite material of the headgear tubing 9060 includes a double-walled film (which may be formed by, for example, a first air-retaining material 9120 and a second air-retaining material 9130 joined at their respective opposing longitudinal ends 9125) that defines an internal cavity or conduit 9140. The first and second air-retaining materials 9120 and 9130 each have an inner and outer surface. The double-walled film has an outer surface formed by the outer surface 9120a of the first air-retaining material and the outer surface 9130a of the second air-retaining material. The inner surface of the double-walled film is formed by the inner surface of the first air-retaining material and the inner surface of the second air-retaining material. The inner surface of the double-walled film forms a cavity or conduit through which air can pass. The double-walled film may include a first film 9120 forming a first wall and a second film 9130 forming a second wall, which are positioned spaced apart to allow air to flow between the first and second walls. Films 9120 and 9130 are impermeable to pressurized air. For this purpose, the cavity 9140 within the double-walled film (formed from the first air-retaining material 9120 and the second air-retaining material 9130) may contain pressurized air. In the absence of pressurized air, the cavity 9140 is not filled with pressurized air and is in a collapsed state (Figure 9F). This collapsed state may also include embodiments in which a gap is maintained between the inner surfaces of the first and second air-retaining materials when there is no airflow. The gap may be formed, for example, by providing the first air-retaining material with more material than the second air-retaining material. When pressurized air flows through the cavity, the cavity 9140 is in an expanded state (Figure 9G). Thus, when the cavity 9140 of the composite material transitions from an expanded state to a collapsed state, the headgear tubing 9060 can also transition from an expanded state to a collapsed state in order to supply pressurized air to the patient.

[0233] In some embodiments, the first fabric layer 9150 is connected to the outside of the first air-retaining material 9120a. The first fabric layer 9150 may be used as the outer surface of the headgear tubing. The first fabric layer 9150 may be a mesh fabric layer. The second fabric layer 9160 is connected to the outside of the second air-retaining material 9130a. The second fabric layer 9160 may be used as the inner surface of the headgear tubing that comes into contact with the patient's skin during use. Thus, when used to form the headgear tubing 9060, the smooth finish provided by the second fabric layer 9160 may come into contact with the patient's head during use, thus providing comfort.

[0234] As shown in Figures 9F and 9G, the headgear tubing may also include fastening portions 9050, which are described in detail below. The fastening portions 9050 may be formed in the gaps of the first air-retaining material 9120. The fastening portions function as an air-sealing layer such that the cavity is defined by the first and second air-retaining materials and the air-sealing layer (or fastening portion 9050). Other versions in which the first air-retaining material is continuous (i.e., without fastening portions, for example) are also possible and are within the scope of the present invention.

[0235] As shown in Figure 9H, the headgear tubing has a length that generally extends along the longitudinal axis 9180 between the inlet 9040 and the outlet 9030. The airflow through the headgear tubing flows generally along the longitudinal axis 9180 between the inlet 9040 and the outlet 9030. The headgear tubing has a first transverse axis 9190 that generally extends laterally with respect to the longitudinal axis 9180 of the headgear tubing, and a second transverse axis 9200 that is perpendicular to the first transverse axis 9190 (and also generally laterally with respect to the longitudinal axis 9180). In the illustrated example, the first transverse axis 9190 may extend between the fastening portion 9050 and the second fabric layer 9160 (see, for example, Figures 9F-9H). In other words, the first transverse axis 9190 may cross the patient's skin (e.g., laterally, perpendicularly, etc.) during use. The second transverse axis 9200 may extend substantially perpendicular to the first transverse axis 9190 so that the second transverse axis 9200 extends along the patient's skin during use. The second transverse axis 9200 may also extend along the width of the foam 9170 and / or air-folding material 9130 without crossing both the foam 9170 and the air-retaining material 9130. Comparing Figures 9F and 9G, the headgear tubing is selectively expandable in the first direction (generally along the first transverse axis 9190) compared to the second direction (generally along the second axis 9200). For example, the headgear tubing may expand away from the patient's head along the first transverse axis 9190. In other words, the first direction may be laterally away from the patient's skin. Lateral expansion toward the patient's head may be limited by the patient's skin (although expansion toward the patient's head along the first transverse axis 9190 may occur). Alternatively, the headgear tubing may expand in the first direction rather than the second. For example, the headgear tubing may expand in the second direction (e.g., towards the top of the patient's head (e.g., the area resting on the parietal bone) and / or towards the mandible) but may expand more in the first direction (e.g., laterally away from the patient's face). This can be achieved by having an asymmetrical geometry or by changing the material properties of the headgear tubing.For example, the first and second air-retaining materials 9120 and 9130 may have greater elasticity or expandability along the first transverse axis 9190 relative to the second transverse axis 9200. Alternatively, more material may be provided to the first air-retaining material 9120 compared to the second air-retaining material 9130 in order to make the first air-retaining material movable relative to the second air-retaining material (in a first direction along the first transverse axis 9190).

[0236] Selective expansion in the first direction over a second direction can be strain expansion. This can be represented by a sigmoid curve in the stress-strain plot. In the initial stages, the headgear tubing generally overcomes the initial stiffness in the first direction along the first transverse axis 9190. As the pressurized air in the conduit increases, the conduit "attracts attention" and pressure accumulates before the headgear tubing begins to expand. This can be represented by an initial increase in stress (plateau region) without an increase in strain. During expansion, the stress-strain curve flattens as the pressure in the conduit remains constant while the conduit expands. As the pressure increases further, the expansion of the conduit slows down and eventually the expansion of the conduit stops.

[0237] Alternatively, selective expansion in the first direction rather than the second direction may be low-strain expansion. In this regard, the conduit is sized appropriately so that the stress-strain curve does not extend beyond the plateau region when it expands.

[0238] In one embodiment of the headgear, the headgear tubing 9060 is substantially planar or flat when compressed. In another embodiment, when compressed, the first and second air-retaining materials are not under tension that would cause them to be pushed apart from each other. When expanded, the pressurized air expands the cross-sectional shape of the headgear tubing to, for example, a semicircular, dome-shaped, lenticular, rounded rectangular, or elliptical shape. The change in the cross-sectional shape of the headgear tubing may be a result of how the headgear tubing is formed. For example, a double-walled film may be formed as a tubular or cylindrical structure. For example, the first and second air-retaining materials forming the double-walled film may be obtained directly by a blow extrusion process using an annular die. In this regard, the first and second air-retaining materials are joined together to form a continuous film. The first side surface of the first air-retaining material may have positive curvature, and the second side surface of the second air-retaining material may have negative curvature. Therefore, when the headgear tubing is viewed in cross-section, the first and second sides can be separated proportionally from each other in the presence of pressurized air. As shown in Figure 9G, the double-walled films 9120 and 9130 can be formed by bonding or joining two films at their ends. For example, two pieces of film 9120 and 9130 can be stacked and their ends sewn together to form a double-walled film. The two pieces of film 9120 and 9130 can be stacked and joined at their ends by radio frequency (RF) welding or ultrasonic lamination. RF welding (also called high-frequency (HF) welding or dielectric welding) is a method of joining together thin sheets of polar thermoplastic material. It uses high-frequency (13-100 MHz) electromagnetic energy to fuse the materials. A rapidly alternating electric field is set between two metal welding rods. The electric field vibrates polar molecules found in some thermoplastic resins, causing them to be oriented relative to the electric field. The energy generated by this process causes a temperature rise that leads to the melting of the material. Combined with the pressure from the clamp on the welding rod, a weld is formed.

[0239] When viewed in cross-section, the first side has a positive curvature and the second side has a zero curvature such that the ends of the film meet to form an internal cavity like a semi-circle or dome. This can be achieved by providing an excess of foaming material in the first air retention material 9120 compared to the second air retention material 9130. Alternatively, the first side may have a zero curvature and the second side may have a negative curvature. This can only be achieved by applying tension to the second air retention material 9130 such that it has a lower stretchability than the first air retention material 9120. When inflated, the second air retention material 9130 cannot expand further and only the first air retention material 9120 can expand elastically to accommodate an increase in air pressure. When an annular continuous film is used as the first and second air retention materials, the second fabric layer 9160 can be a strong (absorbing energy and plastically deforming without breaking) but flexible material such that the second fabric layer is not stretched when the headgear tubing is inflated. In either case, the flat portion is maintained on the second fabric layer 9160. The flat portion when inflated conforms well to the patient's head and allows for improved comfort. The flat shape also allows the patient to lie on their side without obstruction.

[0240] The composite material may further have a flexural modulus of less than 15 N / mm 2 In other embodiments, the flexural modulus is less than 14 N / mm 2 less than, 13 N / mm 2 less than, 12 N / mm 2 less than, 11 N / mm 2 less than, 10 N / mm 2 less than, 9 N / mm 2 less than, 8 N / mm 2 less than, 7 N / mm 2 less than, 6 N / mm 2 less than, 5 N / mm 2 less than, 4 N / mm 2 less than, or 3 N / mm 2 less than. In other embodiments, the flexural modulus is about 5 N / mm 2 is. Thus, when the headgear tubing is made from the composite material, 15 N / mm 2It may have a flexural modulus of less than .

[0241] This allows the headgear, in its compressed state (Figure 9F), to be elastically deformable. In this state, the headgear tubing is foldable on its own. This makes it possible to fold and store the headgear in a compact size. This type of structure is also less bulky and more convenient than previous headgear configurations.

[0242] When the headgear is in a compressed state, the width and thickness of the headgear tubing along the first transverse axis 9190 are approximately 0.5 mm to 10 mm, 0.5 mm to 8 mm, 0.5 mm to 6 mm, 1 mm to 6 mm, 2 mm to 6 mm, or 3 mm to 6 mm. When the headgear is in an inflated state, the width and thickness of the headgear tubing along the first transverse axis 9190 are approximately 5 mm to 40 mm, 10 mm to 40 mm, 15 mm to 40 mm, 20 mm to 40 mm, 25 mm to 40 mm, 30 mm to 40 mm, or 35 mm to 40 mm.

[0243] The ability of the headgear tubing in a first direction along the first transverse axis 9190 to adapt to the expansion of the conduit can be characterized by its flexural modulus. In this regard, if the double-walled film is formed from a first air-retaining material and a second air-retaining material, the first air-retaining material may bend away from the second air-retaining material. In some embodiments, the flexural modulus is 15 N / mm². 2 It is less than 14 N / mm². In other embodiments, the flexural modulus is 14 N / mm². 2 Less than 13 N / mm 2 Less than 12 N / mm 2 Less than 11 N / mm 2 Less than 10 N / mm 2 Less than 9 N / mm 2 Less than 8 N / mm 2 Less than 7 N / mm 2 Less than 6 N / mm 2 Less than 5 N / mm 2 Less than 4 N / mm 2 Less than 3 N / mm2 It is less than. In other embodiments, the flexural modulus is about 5 N / mm². 2 That is the case.

[0244] The headgear tubing in the second direction along the second transverse axis 9200 has a thickness of approximately 5 mm to approximately 30 mm. The headgear tubing in the second direction along the second transverse axis 9200 may have a thickness of approximately 5 mm to approximately 50 mm. The thickness of the headgear tubing in the second direction along the second transverse axis 9200 may vary along the length of the headgear tubing. In particular, a greater thickness is desirable at the top of the headgear or near the exit of the headgear to add stability.

[0245] The headgear further includes a tension structure 8020 or 9020. The tension structure is intended to provide force to maintain the exit in the position of use.

[0246] The headgear tubing is sized to conform to the contours of the patient's head. When the headgear tubing is inflated, pressurized air of at least 6 cmH2O compresses the headgear against the patient's head, creating a tight seal. This minimal pressure prevents the headgear from shifting during use. This further ensures that the seal of the seal-forming structure does not loosen during use. The headgear can be manufactured in a single size and, when used with a flow of pressurized air, can conform to the shape of the patient's head, making it suitable for a variety of head sizes.

[0247] Headgear tubing 8060 or 9060 may be made from a stretchable composite material. In one embodiment of this art, headgear tubing 9060 has greater stretchability in at least a portion of its longitudinal axis 9180 than in a second direction along a second transverse axis 9200. The headgear tubing may have greater stretchability in at least a portion of its longitudinal axis 9180 than in a second direction along a second transverse axis 9200. For example, the Young's modulus along the length may be lower than the Young's modulus along the second transverse axis 9200. Stretchability is advantageous for conforming to complex and intricate body surfaces. For example, non-uniform stretching allows for a better fit to the patient's head by enabling a wider fit curve without sacrificing the rigidity of the conduit. Stretchability can be tested by measuring the force before breakage under bidirectional stretching.

[0248] The headgear tubing has a load capacity of approximately 15 N / mm. 2 ~Approx. 150N / mm 2 It may have a tensile modulus (or Young's modulus or modulus of elasticity). In other embodiments, the tensile modulus is about 15 N / mm². 2 ~Approx. 120N / mm 2 , about 15N / mm 2 ~Approximately 100 N / mm 2 , about 15N / mm 2 ~Approximately 80 N / mm 2 , or approximately 15 N / mm 2 ~Approx. 50N / mm 2 In other embodiments, the tensile modulus is approximately 15 N / mm². 2 In some embodiments, the headgear tubing may have a lower tensile modulus along its longitudinal axis 9180 than along the first and / or second transverse axes 9190, 9200, in order to better fit a variety of head sizes. In other embodiments, the headgear tubing along the second transverse axis 9200 may have a lower tensile modulus compared to the headgear tubing along the first transverse axis 9190.

[0249] The flexural and tensile moduli of composite materials are provided herein, but the moduli can be a combination of the material properties of the individual layers constituting the composite material. For example, the inventors have found that patient comfort is improved by balancing longitudinal forces with tensile strain due to transverse expansion. In this regard, the difference in moduli along the longitudinal axis 9180 and the transverse axis 9190, 9200, or both.

[0250] Features of another embodiment of the headgear 11010 are shown in Figure 11. The headgear 11010 has an air inlet 11040 and an air outlet 11030. Further details of the air inlet 11040 are shown in Figure 11D. The inlet 11040 may be connected to a pneumatic tubing 4170 that extends toward the posterior region of the patient's head. The first fabric layer 11050 is a mesh material, and the second fabric layer 11060 is a breathable fabric material. As seen in Figure 11C, the second fabric layer 11060 extends over the first fabric layer 11050, and its excess portion is folded over to cover the longitudinal sides of the first fabric layer 11050. Thus, the second fabric layer 11060 may be bonded and / or sutured to the first fabric layer 11050.

[0251] Alternatively, different woven composite materials may be used to construct the headgear tubing, as shown in Figure 11E. For example, different fiber composite materials may be used to construct the headgear tubing along its length. For example, the headgear 11000 may include a first fabric layer 11050a which may have a different stiffness than the first fabric layer 11050b. The first fabric layer 11050a is fitted to cover the patient's nostrils, and the first fabric layer 11050b is fitted to cover the patient's mouth. Each of the first fabric layers 11050a and the first fabric layer 11050b may be composed of multiple parts that can selectively supply different pressures, thereby having different relative stiffness / flexibility between the first fabric layer 11050a and the first fabric layer 11050b. For example, the first fabric layer 11050a may be a single part, while the first fabric layer 11050b may consist of two parts. To facilitate nasal breathing, the stiffness of the first fabric layer 11050b may be increased so that its stiffness is greater than that of the first fabric layer 11050a.

[0252] Different woven composite materials may be used to provide the first fabric layer 11050a and the first fabric layer 11050b. For this purpose, various fiber composite materials may be bonded, sutured, or welded along their length to form the headgear. When formed in this manner, two or more substantially parallel headgear tubings may be provided to supply air separately to the patient's nostrils and mouth. Different pressurized air may be supplied within the conduits of the headgear tubing, thus allowing the air pressure to the nostrils and mouth to be adjusted separately for improved comfort. Alternatively, adjacent fiber composite headgear tubings may be fluidly connected so that only one pressurized air source is required. In this configuration, the rigidity or flexibility of the fiber composite material may be provided by the material used, for example, in the first fabric layers 11050a and 11050b.

[0253] Another embodiment of the headgear 12010 is shown in Figure 12. In contrast to the embodiment in Figure 11, the second fabric layer 12060 does not overlap with the first fabric layer 12050. Rather, the first fabric layer 12050 and the second fabric layer 12060 are substantially similar in size and are bonded and / or sewn to each other.

[0254] At least some forms of headgear based on this technology offer comfort and user desirability. Comfort can be enhanced by using lightweight materials such as fabric and arranging the headgear to conform to the contours of the patient's head. Patients are expected to wear the headgear for approximately 12-15 hours per day. For this purpose, patient comfort can be improved by making the headgear washable. Reusable headgear is also desirable to reduce waste and costs. The headgear is expected to be reusable at least 30 times within a 3-month service life.

[0255] To put on or take off the headgear, the patient may remove or loosen the tensioning structure (if any) and slide the headgear onto their head to fit. The air inlets are positioned in the cranial region, roughly in the sagittal plane. The patient then fits the sealing structure adjacent to the nostrils and / or mouth. The tensioning structure is then secured and / or tightened to further fasten the headgear to the patient's head. The headgear tubing and / or tensioning structure (or part thereof) can be stretched sufficiently to allow for putting on and taking off without significant adjustment. In this way, the patient does not need to readjust or remove any part of the headgear, and it helps to ensure that the adjustments made by the patient are maintained for continuous use. In other words, the headgear can be adjusted once by the patient and then remain properly adjusted, regardless of whether the patient wears the headgear or not. This may be beneficial because it allows the patient to be more certain that the sealing structure, after being adjusted to a preferred position (e.g., a preferred angle α1) during the first use, remains in the proper position each time it is used continuously. 5.3.3.1 Fastening parts

[0256] The headgear tubing may further include a fastening portion 9050, as shown in Figure 9. The fastening portion 9050 may be on a second fabric layer 9160 or on a first fabric layer 9150. If it is on the second fabric layer 9160, the fastening portion 9050 is located on the inner surface of the headgear and is therefore "hidden" when the headgear is in use. Alternatively, if the fastening portion 9050 is on the first fabric layer 9150, the fastening portion is located on the outer surface of the headgear and is therefore visible when the headgear is in use. The fastening portion 9050 may be opened to expose the double-wall films 9120 and 9130. Thus, the patient can access the inside of the cavity 9140. This facilitates cleaning of the cavity 9140 of the headgear and provides the patient with peace of mind regarding the hygiene of the product.

[0257] The fastening portion 9050 is in contact with the headgear tubing 9060 along its length. The fastening portion 9050 may be formed as part of a first or second fabric layer. The fastening portion 9050 may also be formed as part of a double-wall film. For example, referring to Figures 9F and 9G, the fastening portion fluidly connects two pieces of fabric to form a continuous first fabric layer 9150. Combined with a second air-retaining material 9130, an airtight conduit that can adapt to increasing air pressure is formed. The fastening portion 9050 may fluidly connect two pieces of air-retaining material to form a continuous first air-retaining material 9120. Combined with a second air-retaining material 9130, an air-retaining conduit that can adapt to increasing air pressure is formed. The fastening portion 9050 may extend from a first position closest to the inlet to a second position closest to the outlet. This allows for complete cleaning of the cavity.

[0258] Fastening components include, but are not limited to, zippers, tapes, and hook-and-loop fasteners.

[0259] Referring to Figure 10A, the headgear includes a fastening portion. The fastening portion is a zipper. The fastening portion 10060 when the headgear tubing is substantially fastened is shown in Figure 10B. As shown in Figure 10C, the fastening portion can be released to expose a cavity, and thus the inner surface 10070 of the double-walled film of the headgear tubing. 5.3.3.2 Fiber composite materials for headgear tubing

[0260] One form of the fiber composite (or composite material) is shown in Figure 13A. As described above, in some embodiments of the art, the headgear tubing is formed from fibers, which may be a textile composite material having at least a double-walled film having an internal cavity and an external surface. The composite material may further include one or more fabric layers on the first and second sides of the double-walled film. As shown in Figure 13A, the composite material 13000 includes an internal cavity or conduit 13060, which may be formed by a first air-retaining material such as film 13020 and a second air-retaining material such as film 13030. The air-retaining materials (films 13020 and 13030) are impermeable to pressurized air and therefore can retain pressurized air within the internal cavity. The first air-retaining material (film 13020) has an inside and an outside, the outside being the first side surface 13070, which is outward-facing and distal to the internal cavity 13060. The first fabric layer 13010 is connected to the first side surface 13070. The second air-retaining material (film 13030) has an inner and outer side, the outer side being the second side surface 13080, which is outward-facing and distal to the internal cavity 13060. The second fabric layer 13040 is connected to the second side surface 13080. The connection of the first fabric layer 13010 to film 13020 and the connection of the second fabric layer 13040 to film 13030 can be made by lamination or adhesion such as adhesives (dry, hot melt, reactive). Alternatively, ultrasonic lamination or RF welding may be used.

[0261] The second fabric layer 13040 may be thicker than the first layer 13010. This improves patient comfort as the second fabric layer comes into direct contact with the patient's head. For example, the fabric may be thick enough to provide a cushioning effect. An example of the second fabric layer 13040 may be a soft nonwoven fabric or spacer material for thermal and moisture comfort.

[0262] Alternatively, the foam material 13050 may be sandwiched between the second side 13080 and the second fabric layer 13040. The foam material provides further comfort to the patient during use. To further enhance comfort, the thickness of the foam may be varied, or at least two layers of foam material may be used.

[0263] The foam material can also be sandwiched between the first side and the first fabric layer. When positioned in this way, the bulge provided by the foam can prevent obstruction of the conduit when the patient is lying on their side.

[0264] Another embodiment of the composite material is shown in Figure 13C, where another (third) fabric layer 13090 is incorporated to connect to the second side 13080. In this way, the foam layer 13050 is sandwiched between the second fabric layer 13040 and the further (third) fabric layer 13090. This provides an improved connection of the film 13090 to the fabric that comes into contact with the patient's head during use. This is because the porous and soft nature of the foam can result in a weak connection of the film to the foam, which can lead to the patient feeling that the headgear tubing "moves" during use.

[0265] In one embodiment of this technology, the headgear tubing and / or composite material has a load of 15 N / m 2 It has a flexural modulus of less than 1. This allows for contractility (elastically deformable and foldable) so that the headgear can be folded and stored in a compact size when not in use. By selecting elastic fibers, a one-size-fits-all design can be created to fit all headgear and / or patient interfaces.

[0266] If the first fabric layer 9150 is a mesh fabric, the film 9120 attached to the first fabric layer 9150 may have high transparency. This allows the patient to see into the cavity and judge its cleanliness. The film 9130 attached to the second fabric layer 9160 may have lower transparency accordingly, which limits the visibility of the underlying structure and provides a good background that the patient can see through the first fabric layer 9150 and film 9120. In this regard, the film 9120 adjacent to the first fabric layer 9150 may have a higher total transmittance compared to the total transmittance of the film 9130 adjacent to the second fabric layer 9160. The first fabric layer 9150, or at least a portion of the first fabric layer 9150, may have a partially transparent or translucent structure. For example, a partially transparent or translucent structure may be a mesh-like structure that provides a window for the user to see inside through the transparent or translucent portion. The fabric may be constructed with a predetermined mesh opening size, shape, and pattern to allow optimal observation of the inside of the tube through the layer. Alternatively, a fabric made of high-gauge monofilament that provides sufficient transparency and / or translucency may be used.

[0267] In one form of this technology, the film has a total transmittance of over 90%. Due to the film's high transmittance, it can provide a "see-through" function that allows the patient to inspect the cleanliness of the headgear tubing. This provides reassurance to the patient.

[0268] For example, the film may be selected from thermoplastic polyurethane. Materials that can offer these properties include those manufactured by Darlington Corporation, known as DARLEXX®; 3M products, known as THINSULATE®; polytetrafluoroethylene (PTFE) materials, known as GORETEX®; or products known as ATLANTECH®, manufactured by Atlantis Weather Gear Inc.

[0269] In one embodiment of this technology, fibers are used to form a headgear. The fibers may be used to substantially cover the double-wall films 9120 and 9130. For example, the first fabric layer 9150 may be connected to the first side via heat bonding or adhesive bonding. The first fabric layer 9150 may be connected to the first side via point adhesive bonding. The first fabric layer provides transparency and allows for confidence in the cleanliness of the cavity. The first fabric layer also has a good feel. The first fabric layer may have a knitted structure selected from single jersey, rib, interlock, raschel, or jacquard. In other embodiments, the fibers may be opaque or intrinsically transparent materials that have transparency allowing the patient to see through the material. In other embodiments, the first fabric layer is a mesh fabric layer. A mesh fabric is a type of fabric characterized by a mesh-like open appearance with gaps between the threads. Mesh is available in a variety of structures, including woven, knitted, lace, and crocheted fabrics. Examples of mesh fabrics include the following: A. Polyester Mesh: This type of fabric is lightweight and has a remarkable ability to wick away moisture. Unlike other types of fabrics, polyester mesh does not feel sticky with sweat and is highly breathable. B. Nylon mesh: This type of mesh is lightweight but more rigid than polyester mesh. C. Tulle: This type of mesh can be made from silk. D. Power Mesh: Power mesh is known for its compression capabilities. This type of fabric is almost completely transparent. It is named for its high elasticity. E. Powernet: This type of mesh fabric is characterized by a relatively dense weave.

[0270] The first fabric layer 9150 and the second fabric layer 9160 may each be a composite fabric or fiber. A composite fabric or fiber is a material made from two or more constituent materials. A composite fabric or fiber may also have a weave pattern that provides, for example, the strength of the composite fabric or comfort to the patient. Within the finished composite fabric product, the individual components remain separate and identifiable. A composite fabric may be formed as two or more constituent materials intertwined with each other as a single sheet or layer of fabric. Alternatively, a composite fabric may consist of two or more layers, each layer containing a different adjacent fabric. For example, different types of fibers, foams, fiberfills, spacer fabrics, nonwovens, knits, and wovens may be used. The spacer fabric may be a multifilament spacer fabric. A composite fabric with layers of different materials makes it possible to give the headgear the advantages of each material.

[0271] The second fabric layer 9160 may be connected to the second side by heat bonding or adhesive bonding. For example, the second fabric layer 9160 may be connected to the second side via point adhesive bonding. The second fabric layer 9160 may be made of an opaque material. The second fabric layer 9160 may be selected from microfiber yarn, nylon 6,6, peach skin finish, elastic knit fabric, bidirectional stretch fabric, non-stretch fabric, circular knit fabric, woven fabric, or warp knit fabric.

[0272] The second fabric layer 9160 may be further surface-treated with a hydrophobic coating. This prevents the fabric from absorbing sweat from the patient's skin, thus prolonging the degradation of the film. The second fabric layer 9160 may also be surface-treated with minerals to aid blood circulation. The second fabric layer 9160 may also be surface-treated with a hydrophobic and / or lipophilic coating for moisture absorption functionality.

[0273] In one embodiment of this technology, a second fabric layer 9160 and a first fabric layer 9150 overlap. The second fabric layer 9160 can be annealed to the first fabric layer 9150 by heat bonding or adhesive bonding. Alternatively, the second fabric layer 9160 can be bonded or attached to the first fabric layer 9150 by any other means. This can provide further reinforcement of the film to prevent rupture.

[0274] Fiber-based composite materials enable temperature and moisture control, improving patient comfort levels. Fibers can also provide a soft touch and pleasant feel, offering a gentle and comfortable treatment experience for patients. Selecting elastic fibers eliminates the need for adjustments using clips, for example. This simplifies headgear use and improves compliance with patient interface usage. Furthermore, one-size-fits-all designs can be created to fit all headgear and / or patient interfaces, thus reducing manufacturing costs.

[0275] In one embodiment of this technology, Figures 9F and 9G show a headgear tubing and / or composite material further comprising a foam 9170 sandwiched between a second fabric layer 9160 and a second side of a double-wall film 9130. The foam 9170 may be an aerogel (such as silica aerogel or carbon aerogel), or a polyurethane foam such as a shape memory foam or latex foam. The foam may be of a fast-recovering (elastic) type or a slow-recovering (memory foam) type. Alternatively, a soft material such as a microfiber or nonwoven fabric layer may be provided instead of the foam. Softness may be incorporated into the fabric manufacturing itself, for example, by using a thick, soft fabric structure, spacers, or jacquard. The layer may be given thermal and moisture management properties (porosity, absorption). This functions as a cushion, providing further comfort to the patient.

[0276] In one embodiment of this technology, the headgear tubing further includes another (third) fabric layer. The third fabric layer may be sandwiched between the film 9130 and the second fabric layer 9160. In some embodiments, a foam 9170 is sandwiched between the second fabric layer 9160 and the third fabric layer. The second fabric layer 9160 and the third fabric layer may be made of different types of fabric.

[0277] Depending on the presence of the foam 9170, the second fabric layer 9160 may have a thickness that provides comfort. For example, if the foam 1970 is not present, the second fabric layer 9160 may have an increased thickness compared to the first fabric layer 9150. The second fabric layer 9160 may have a thickness ranging from approximately 0.1 mm to approximately 10 mm. The second fabric layer 9160 can be a double-sided fabric.

[0278] In one embodiment of this technology, the headgear tubing includes seam tape. The seam tape can be used to waterproof the headgear tubing by sealing the connections of the headgear tubing and / or adjacent components. For example, the seam tape may be applied to the longitudinal ends of first and second air-retaining materials and / or the connections between the air-retaining materials and fastening portions (if any). For example, Figures 8D and 8E show seam tape 8120 applied to the longitudinal ends of a double-wall film. The seam tape may include a heat-activated adhesive applied to the double-wall film on one side and a waterproof and / or non-porous membrane on the other side. The seam tape can be used to prevent water (and / or air) from entering through seams or needle holes created when sewing the double-wall film.

[0279] In one embodiment of this technology, the headgear tubing and / or composite material has a thickness of approximately 4 mm to approximately 2 cm. 5.3.3.3 Rigidizer

[0280] Some forms of this technology aim to avoid or minimize the formation of bends and kinks along the inflatable conduit, which may obstruct or restrict airflow during use. For example, as shown in Figure 14A, when headgear 14010 is used and the headgear tubing is bent over the user's head and the conduit is pressurized, the air pressure within the conduit tends to straighten the conduit, but the conduit must conform to the user's head, which can cause the conduit, and thus the headgear, to fold and / or collapse. If the curvature of the user's head is greater, for example, if the user is a child and the curvature of the curved part is greater, the airflow may be further restricted. This is shown as a kink 14020. If the headgear is pulled, the lateral force flattens the layers and restricts the airflow. Furthermore, because the inflatable conduit tends to straighten and correct itself, a good fit (and / or contact) with the user's head is not always obtained over the conduit, and by extension, the entire headgear.

[0281] Therefore, to overcome or at least improve this problem, rigidizers and / or stiffeners may be incorporated into the headgear. For this purpose, as shown in Figure 14B, the headgear 14000a includes a rigidizer or stiffener (hidden) that can maintain the curved, kink-free shape of the headgear during use. A generally smooth curvature and good inflation with minimal or no folding can be obtained. Even after incorporating the rigidizer, the headgear remains flexible and scrunchable.

[0282] The rigidizer can be positioned within the headgear tubing, and in some embodiments, it can be bonded to the outer surface of the double-walled film. For example, referring to Figure 21, the rigidizer 21010 can be positioned in contact with the second air-retaining material 21020. In other embodiments, the rigidizer 21010 is bonded to the second air-retaining material 21020. It has been found that when the rigidizer 21010 is positioned closer to the patient's head, the rigidizer 21010 and, consequently, the headgear can conform more closely to the shape of the patient's head. Preferably, the rigidizer 21010 is sandwiched between the first fabric layer 21030 and the second fabric layer 21040. This hides the rigidizer 21010 from the user, providing a more visually appealing product.

[0283] Referring to Figure 21, the rigidizer 21010 may be positioned to be in contact with the foam 21050, if present. The rigidizer 21010 may be positioned between the outer surface of the double-wall film in the second air-retaining material 21020 and the foam 21050. The foam 21050 may be positioned between the double-wall film of the second air-retaining material 21020 and the second fabric layer 21040. This prevents the hard surface of the rigidizer 21010 from being felt by the patient during use. Alternatively, the rigidizer 21010 may be positioned within the foam or sandwiched between the two layers of foam (21050 and 21060). This reduces or eliminates the uneven surface that could cause airflow disturbance, which would result from attaching the rigidizer 21010 to the outer surface of the double-wall film.

[0284] Figure 15A shows an exploded view of the components of the headgear tubing 15000 having a rigidizer 15220. The headgear tubing includes a double-walled film having a first side surface 15020 and a second side surface 15030. The rigidizer is positioned between the second side surface 15030 and a second fabric layer 15040 of the double-walled film. The first fabric layer 15100 covers the first side surface 15020 of the double-walled film. The rigidizer 15220 includes a spine structure 15230 that extends substantially along the length of the headgear and a projection 15240 that extends outward from the spine structure. The projection 15240 is positioned along the spine structure 15230 for about two-thirds of its length. As shown in Figure 15A, the rigidizers for both the left and right sides of the headgear are formed as a single unit having a ring-shaped collar structure approximately midway along the length of the rigidizer 15220.

[0285] Figure 15A shows a rigidizer 15220 that traverses the entire length of the headgear tubing 15000. Figures 15B and 15C show, for illustrative purposes, other embodiments of the rigidizer attached to a second fabric layer 15040. The spine structure 15230 and projection 15240 may be formed with different widths and lengths to provide a range of rigidity and support. The length of the spine 15230 may be about two-thirds of the length of the headgear tubing.

[0286] In Figures 15B and 15C, the rigidizer 15220 may have a length that extends at least partially along the headgear tubing. For example, the rigidizer 15220 may at least partially traverse the length of the headgear and / or patient interface. This supports and stabilizes the seal-forming structure and / or plenum chamber.

[0287] The width of the rigidizer 15220 may be approximately the same as the width of the headgear tubing along the second transverse axis. Alternatively, the width of the rigidizer may be a portion of the width of the headgear tubing along the second transverse axis. For example, the width of the rigidizer 15220 may be less than approximately 90% of the width of the headgear tubing along the second transverse axis, or less than approximately 80%, 70%, 60%, or 50%. In other embodiments, the width is less than approximately 50% of the width of the headgear tubing along the second transverse axis. As shown in Figure 16C, the width of the rigidizer 16280 may be about 1 / 4 to 1 / 2 of the width of the headgear tubing along the second transverse axis. This provides sufficient support to the headgear without significantly increasing manufacturing costs. By extending the width of the rigidizer to more than 1 / 2 of the width of the headgear tubing along the second transverse axis, better support can be provided while minimizing the presence of kinks, thus offering users a high-end appeal.

[0288] The rigidizer 15220 may include a spine structure 15230 that extends at least partially along the headgear and / or patient interface. In this regard, since the spine structure 15230 follows the contour of the expandable conduit, the spine structure may be straight, curved, or bent. The spine structure 15230 may be positioned in adjacent central regions along the length of the double-walled film. This is advantageous for providing concentrated support to the expandable conduit.

[0289] The spine structure can have a width of approximately 1 mm to 10 mm. As shown in Figure 16C, the width of the spine structure 16270 can be approximately 5 mm. Various widths can be used to obtain various levels of stiffness. In areas of headgear tubing where curvature is large and therefore greater stiffness is required, the width of the spine structure can be increased. In this regard, the spine structure can have a width that varies along its length. For example, the spine structure may have a tapered profile, with a thicker width near the air inlet and a thinner width near the plenum chamber. For example, the width may be approximately 4 mm to 5 mm at one end and approximately 2 mm to 3 mm at the other end.

[0290] Furthermore, the cross-sectional thickness of the spine structure can vary across its width. For example, the thickness of the side edges may be thinner than that of the central region of the spine structure. In this respect, the spine structure may have a curved or domed cross-section. This increases the support provided by the rigidizer.

[0291] The rigidizer 15220 may also include a plurality of projections 15240 extending from at least one side of the spine structure. The projections 15240 are spaced apart from each other along the length of the spine structure. For example, the rigidizer may be formed as a fishbone structure.

[0292] Each of the projections 15240 may have the same length and / or width. Alternatively, the length and / or width of each projection may differ depending on its position along the spine structure and its position along the length of the headgear tubing.

[0293] The projection 15240 may have a length shorter than the length of the spine structure. The projection may have a length longer than the width of the spine structure. The projection may have a width / shape that is thinner than the width of the spine structure.

[0294] The protrusion 15240 can take on various shapes. For example, the protrusion may have a rectangular shape. Alternatively, the protrusion may have a curved shape, such as a curved spike. The curved shape may have a rounded tip.

[0295] The projections 15240 can be positioned at various angles relative to the spine structure 15230. For example, each projection may have a contact angle (contact point of the spine structure) of about 90° with respect to the spine structure. As used herein, the contact angle refers to an angle of 90° or less (acute angle) measured at the point where the projection intersects the spine structure. With respect to the collar structure, the acute angle may be forward or backward. The projections may further each have a contact angle of about 20° to about 60°. Preferably, the projections are about 30° to about 50°, or about 35° to about 45°.

[0296] The projections 15240 may be formed on one side of the spine structure 15230, or on both sides of the spine structure. If formed on both sides of the spine structure, each projection on one side of the spine structure may have a projection facing the other side. The projections and the opposite projections may be molded and / or positioned symmetrically. For example, the contact angles of the projections and the opposite projections may be the same or similar. Alternatively, the projections may be arranged on two sides of the spine structure such that the projections on one side are offset along the longitudinal direction relative to the projections on the other side, giving an alternating pattern. Figure 20B shows an example of an offset arrangement of the protrusions.

[0297] Some of the projections 15240 can be joined to provide additional strength and / or support to specific parts of the headgear. For example, Figure 16 shows the components of a headgear tubing 16000 having a rigidizer 16220. The rigidizer 16220 is sandwiched between a second fabric layer 16040 and a second side surface 16030 of a double-wall film. A first side surface 16020 of the double-wall film is adjacent to the first fabric layer 16100. The rigidizer 16220 includes a spine 16230 and a plurality of projections 16240. The rigidizer 16220 is formed as a single piece with a collar structure 16250 positioned substantially at the center of its length, extending to the left and right sides of the headgear tubing. The rigidizer 16220 further includes at least one tab 16260 along the side of the spine structure 16230. In this particular embodiment, two tabs 16260 are installed on the right and left sides of the headgear 16000 to connect to a tensioning structure (not shown).

[0298] Figure 18A shows that an adjacent projection 18240 of the rigidizer 18220, positioned near the entrance of the headgear, may be joined with 18260 so that rigidity prevents compression or folding of the entrance during use. Alternatively, part of the projection may be replaced with other structural means such as a tab 18260. When positioned near a tension structure, the tab 18260 may be used to provide additional support and prevent deformation when tension is applied to the headgear.

[0299] Alternatively, Figure 16B shows a tab 16260 connected to the spine 16230, adjacent to and parallel to the projection 16240. In this configuration, the projection is not joined to form the tab 16260. Rather, the tab 16260 is attached directly to the spine 16230 as a separate component. This allows the tab 16260 to be displaced at an angle relative to the spine without twisting the spine and projection.

[0300] The rigidizer 15220 may further include a collar structure 15250. The collar structure 15250 may be positioned at one end of the spine structure. The collar structure is intended to provide additional rigidity to the area adjacent to the air inlet. This ensures that the flow of breathable air into the inflatable conduit is not obstructed, which may occur when the area surrounding the air inlet is compressed as the user turns during sleep. For this purpose, the collar structure is formed to substantially surround the air inlet. The collar structure may be formed as a curved structure or as a straight structure. It may be in any shape as long as the collar structure does not obstruct the air intake and airflow.

[0301] The rigidizer described above is described as a support element that crosses half of the headgear and / or patient interface. In this regard, two rigidizers may be incorporated into the headgear and / or patient interface (for the right side and the left side) to provide support for the entire device. It will be apparent that the rigidizer may be formed as a single unit for incorporation into the right and left sides of the headgear tubing. For this purpose, the rigidizer 16220 may be formed, for example, with a spine structure and a collar which is a C-ring structure 16250 positioned substantially midway along the length of the spine structure. This may be done, for example, by combining the two rigidizers disclosed above with their respective C-ring structures to form a collar structure.

[0302] The rigidizer may further include at least one tab. If the rigidizer with the tab is formed with the inflatable conduit and the tab extends outward from the inflatable conduit, the tension structure may be connected to the tab, thus providing additional support between the inflatable conduit and the tension structure. The tab may include a slit for connecting to the tension structure. The tab may further include at least one cutout portion to give the tab flexibility. The tab has the advantage that when tension is applied by the tension structure, it does not cause flattening of the inflatable conduit (and thus the headgear and / or patient interface).

[0303] The rigidizer is supplied in a thin material. The thickness of the rigidizer may be less than about 2 mm, less than about 1 mm, or less than about 0.5 mm. The thickness of the rigidizer may be about 100 μm to about 2 mm. The thicker the rigidizer, the higher the rigidity and thus the more support is provided. Preferably, the thickness is about 100 μm or about 1500 μm, about 100 μm or about 1000 μm, about 250 μm or about 500 μm, about 200 μm or about 500 μm, or about 250 μm or about 400 μm.

[0304] In one embodiment of this technology, the rigidizer has high elasticity in a second direction along a second transverse axis for at least a portion of its length. The headgear tubing may have high elasticity in at least a portion of its length with respect to the second direction along the second transverse axis. For example, the Young's modulus in length may be lower than the Young's modulus in the second direction along the second transverse axis. The elasticity is characterized by its ability to conform to complex and intricate body surfaces. For example, non-uniform stretching allows for a better fit to the patient's head by enabling a wider fit curve without sacrificing the rigidity of the conduit. Elasticity can be tested by measuring the force before breakage under bidirectional stretching.

[0305] The rigidizer may further include a stretchable portion. The stretchable portion may be part of the spine structure. For example, the stretchable portion may be a zigzag, square wave, wavy, or curved structure. These structures, depending on their design, can be deformed when pulled along the longitudinal axis. This gives the rigidizer stretchability as needed, for example, the top of the head or curved sections. Figures 20D-20D-2 show some examples of stretchable structures on rigidizer 20000. For example, Figures 20D-1 and 20D-2 show that the projections 20240a on both sides of spine 20230 may be in an opposing configuration (see also Figure 20A). Alternatively, Figure 20D shows that the projections 20240b and 20240c may be in an alternating configuration, that is, the projection on one side is spaced laterally relative to the projection on the opposite side (see also Figure 20B). In addition to the elongated structure, the spine 20230a may also have a zigzag structure (see, e.g., Figure 20D), a square wave structure (see, e.g., Figure 20D-1), or a sinusoidal structure (see, e.g., Figure 20D-2). This allows the rigidizer to be expandable and contractible. The spine 20230 may be made from a material that is more rigid than the protrusion, or from an elastomer material. For example, Figure 20C shows a spine 20230 constructed from an elastic material, while the protrusion is constructed from a rigid material. Alternatively, the spine 20230 does not have to be made from an elastomer material, but may be more flexible than the protrusion.

[0306] The headgear tubing has a load capacity of approximately 5 N / mm. 2 ~Approx. 150N / mm 2 It may have a tensile modulus (or Young's modulus or modulus of elasticity). In other embodiments, the tensile modulus is about 5 N / mm². 2 ~Approx. 120N / mm 2 , about 5N / mm 2 ~Approximately 100 N / mm 2 , about 5N / mm 2 ~Approximately 80 N / mm 2 , about 5N / mm 2 ~Approx. 50N / mm 2 , about 10N / mm 2 ~Approx. 50N / mm 2 , or approximately 15 N / mm2 ~Approx. 50N / mm 2 In other embodiments, the tensile modulus is approximately 15 N / mm². 2 In some embodiments, the headgear tubing may have a lower tensile modulus along length 9180 compared to that along the first and / or second transverse axes 9190, 9200, in order to better fit a variety of head sizes. In other embodiments, the headgear tubing along the second transverse axis 9200 may have a lower tensile modulus compared to the headgear tubing along the first transverse axis 9190.

[0307] Rigidizers can be made from plastic or polymer materials. For example, materials such as thermoplastic elastomers may be used due to their strength, flexibility, and elasticity. Nylon, polyamide, polycarbonate, and PC-ABS blends may also be used.

[0308] The spine and projections can be made of different materials. The spine structure may be made of an elastic material, such as an elastomer, while the projections may be made of a more rigid material, such as plastic. The spine may be made of an elastomer such as thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), or silicone rubber, while the projections may be made of a more rigid polymer such as nylon, polyamide, polycarbonate, and PC-ABS blends. The projections may also be made of an elastomer that is more rigid than the spine. Figure 20 shows an embodiment of this configuration. Different materials for the spine and projections can impart different elasticity and / or flexibility, thus enabling a rigidizer that is both elastic and flexible.

[0309] The spine and the projection may have different thicknesses. For example, the spine may be about 1 cm, 2 cm, 4 cm, 5 cm, or 10 cm thicker than the projection.

[0310] Figure 17 shows another embodiment of the rigidizer 17220. The rigidizer 17220 includes a spine structure 17230, a collar structure 17250, and a tab 17260. The width of the spine structure 17230 is approximately 4-5 mm in the region adjacent to the collar structure and approximately 2-3 mm in the region adjacent to the tab 17260. Although the spine structure 17230 is shown as a straight structure, a curved spine structure that conforms to the length of the headgear may also be used.

[0311] Figure 18A shows another embodiment of a rigidizer 18220 bonded to the second side surface 18030 of a double-walled film. The spine structure 18230 extends along the entire length of the side surface 18030 and therefore does not cross the headgear. A gap exists between the collar structure 18250 of the rigidizer and the collar structure of the adjacent rigidizer. The collar structure is formed from two C-ring structures. The gap can be adjusted according to the amount of support required. The width of the rigidizer is approximately 1 / 3 of the width of the side surface 18030. The tab 18260 includes a slit and is formed as a single piece with the rigidizer 18220. For this purpose, some of the protrusions are removed to adapt to the tab 18260.

[0312] Figure 18B shows another embodiment of the rigidizer 18220. In contrast to Figure 18A, the spine structure 18230 is formed to extend along the entire length of the headgear. A projection is formed approximately two-thirds of the length of the rigidizer 18220. Slots are also formed within the tab 18260. The collar structure 18250 is reinforced with additional support ribs.

[0313] Figure 18C shows an embodiment of the headgear tubing 18000 with an internally positioned rigidizer 18220. The rigidizer is positioned next to a soft, thin second fabric layer so that the pattern of the rigidizer can be seen and felt.

[0314] Figure 19 illustrates the principle of the rigidizer 19220 in use. When the rigidizer is bent (when L is bent away from or toward the plane of a flat rigidizer), points 1 and 2 tend to remain on the same plane, while point 3 is on a different plane due to the bending. When the rigidizer 19220 is bonded to a flexible material (film), this property can be used to fix the centerline, and the sides can be lifted relative to the centerline during bending. The projection (fishbone) 19240 is angled with respect to the central spine, so that folds perpendicular to the centerline are not propagated, allowing for the bending flexibility of the film to which the rigidizer is attached.

[0315] Rigidizers can be formed using techniques such as die-cutting from a sheet, injection molding, direct deposition using melt and curing paste, or screen and stencil printing. Selective thermocuring (embossing patterns) and thermal bonding may also be used. Rigidizers can be bonded to the sides of a double-wall film using thermal bonding or thermal bonding via an intermediate film. Alternatively, an adhesive layer may be used.

[0316] To integrate the rigidizer into the headgear, it may be bonded, for example, to the side of a double-walled film. Then, the first and second fabric layers may be stacked to sandwich the double-walled film and the RF-welded components together. If a tab is present in the rigidizer, it may be protected with a protective sheet to prevent it from adhering to the double-walled film. Next, a slit is cut in the second fabric layer for the tab to pass through, and it is inserted into a groove in the mold so that the tab is bonded without being exposed when the components are RF-welded together. Referring to Figures 13A-C, the rigidizer is located, for example, on the second side 13080 between the second air-retaining material 13030 and the second fabric layer 13040.

[0317] The rigidizer may be further bonded to a second fabric layer, or, if present, a foamed material or a third fabric layer, as needed. 5.3.4 Tensile structure

[0318] The seal-forming structure 3100 of the patient interface 3000 of this technology can be held in a sealed position by the tension structure 3300 during use.

[0319] In one embodiment, the tension structure can be positioned to overlap the posterior region of the patient's head.

[0320] In one embodiment, the tension structure 3300 provides at least sufficient holding force to overcome the effect of positive pressure in the plenum chamber 3200 that causes it to lift away from the face.

[0321] In one configuration, the tension structure 3300 provides sufficient holding force to overcome the gravitational force on the patient interface 3000.

[0322] In one embodiment, the tension structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive effects on the patient interface 3000 (for example, those resulting from tube dragging or accidental interference with the patient interface).

[0323] In one embodiment of this technology, a tension structure 3300 is provided that is configured to be worn by a patient while sleeping. In one embodiment, the tension structure 3300 has an inconspicuous shape or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one embodiment, the tension structure 3300 includes at least one strap having a rectangular cross-section. In one example, the tension structure 3300 includes at least one flat strap.

[0324] In one embodiment of this technology, a tension structure 3300 is provided that is configured not to be excessively large or bulky so as not to interfere with a patient sleeping in a supine position with the posterior region of the patient's head resting on a pillow.

[0325] In one embodiment of this technology, a tension structure 3300 is provided that is configured not to be excessively large or bulky so as not to interfere with a patient sleeping in a lateral sleeping position with the side of the patient's head resting on a pillow.

[0326] In one embodiment of this technology, the tension structure 3300 includes a release portion positioned between the front portion and the rear portion of the tension structure 3300. This release portion is not compressible and may be, for example, flexible or a floppy strap. The release portion is constructed and positioned so as to prevent a situation in which, when a patient lies down with their head on a pillow, the presence of the release portion transmits force along the tension structure 3300 toward the rear portion, thereby disrupting the seal.

[0327] In one embodiment of this technology, the tension structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam is porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the fabric outer layer includes a loop material that engages with a hook material portion.

[0328] In one embodiment of this technology, the strap is an elastic band. The strap may be constructed and positioned such that, when in use, at least a portion of its lower edge passes above the upper earlobe of the patient's head and rests on a portion of the parietal bone. Alternatively, the strap may be constructed and positioned such that, when in use, at least a portion of its upper edge passes below the earlobe of the patient's head and rests on a portion of the occipital bone.

[0329] In certain embodiments of this technology, the tension structure 3300 includes a stretchable (e.g., stretchable with elasticity) strap. For example, the strap may be configured to be taut when in use, directing the force that causes the seal-forming structure to adhere to a portion of the patient's face. In one example, the strap may be configured as a tie.

[0330] In one embodiment of this technology, the tension structure is an elastic structure. The tension structure can be made of an elastic material or elastic fiber. For example, thermoplastic polyurethane (such as J Fiber) may be used. Elastic fabrics with a relatively flat load-stretch curve may also be used. Alternatively, a material consisting of 90% nylon and 10% spandex may be used. Such materials allow for stretching, support, cooling, and breathability, improving patient comfort. In addition, the stretch-fit positioning and stabilizing structure can apply a constant compressive force to the patient's head, so the headgear is one-size-fits-all and fits all products.

[0331] For example, the tension structures 8020 and 9020 in Figures 8B and 9A, respectively, are positioned so that, when in use, at least a portion of their lower edges passes above the upper earlobe of the patient's head and rests on a portion of the parietal bone. The tension structure 10030 in Figure 10A and the tension structure 11020 in Figure 11A are positioned so that, when in use, at least a portion of their upper edges passes below the lower earlobe of the patient's head and rests on a portion of the occipital bone. The tension structure 12020 in Figure 12 is positioned so that, when in use, its edge passes above the upper earlobe of the patient's head and rests on a portion of the parietal bone, and also passes below the lower earlobe of the patient's head and rests on a portion of the occipital bone.

[0332] Alternatively, the tension structure may be made of a fiber composite material, as disclosed herein. When formed in this manner, the headgear tubing may extend into the tension structure so that additional support is provided to the posterior region of the patient's head when the conduit of the headgear tubing is expanded during use.

[0333] In one embodiment of this technology, the tension structure includes a first tie, which is constructed and positioned such that, when in use, at least a portion of its lower edge passes over the superior base of the patient's head and rests on a portion of the parietal bone. The first tie may further avoid resting on the occipital bone.

[0334] In another embodiment of this technology, the first tie is constructed and positioned such that, when in use, at least a portion of its upper edge passes under the earlobe of the patient's head and rests on a portion of the occipital bone.

[0335] In another configuration, the first tie is constructed and positioned to pass through both the inferior and superior ear crus of the patient's head and rest on a portion of the parietal and occipital bones when in use.

[0336] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the tension structure includes a second tie. The second tie is constructed and positioned such that, when in use, at least a portion of its upper edge passes below the inferior foot of the patient's head and rests on or below the occipital bone of the patient's head.

[0337] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the tension structure includes a third tie constructed and positioned to interconnect the first tie and the second tie to reduce the tendency of the first tie and the second tie to move in a different direction toward separation.

[0338] In certain embodiments of this technology, the tension structure 3300 includes a flexible and, for example, non-rigid strap. An advantage of this embodiment is that the strap is more comfortable when the patient lies down while sleeping.

[0339] In a particular form of this technology, the tension structure 3300 includes a strap configured to be breathable, allowing water vapor to pass through it.

[0340] In certain embodiments of this technology, a system is provided comprising more than one positioning and stabilizing structure 3300, each positioning and stabilizing structure configured to provide holding force to accommodate different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for a large head rather than a small head, and another form of a small head rather than a large head.

[0341] In a particular embodiment of this technology, the tension structure 10030 further includes a retaining structure 10040. The retaining structure may be a cloth or fiber to provide additional support and stabilization. The retaining structure 10040 may substantially cover the earlobe region of the patient's head.

[0342] In one embodiment of this technology, the tension structure is detachable from the headgear and / or patient interface. This facilitates cleaning for hygienic purposes. The tension structure may be attachable to the headgear and / or patient interface via connecting means. For example, a female connector (such as a tab) extending from the headgear may be coupled to a corresponding male connector (such as Velcro®) on the tension structure. A male connector may also be present on the headgear for coupling with the female connector on the tension structure. The connector on the headgear may be fixed to the end of the inflatable conduit, for example, in the area where the first air-retaining material 9120 and the second air-retaining material 9130 are connected at both ends. Alternatively, the connector on the headgear may be fixed to the surface of the inflatable conduit, for example, the first air-retaining material 9120a or the second air-retaining material 9130a. Even more advantageously, if the connector is fixed to the surface of the expandable conduit, particularly the surface closer to the patient's head, the expanded conduit will not be excessively asymmetrically stretched and / or flattened during use with the tension structure attached. 5.3.5 Ventilation

[0343] In one embodiment, the patient interface 3000 includes a vent 3400 constructed and positioned to allow the expulsion of exhaled gases (e.g., carbon dioxide).

[0344] In a particular configuration, the vent 3400 is configured to allow a continuous airflow from the inside of the plenum chamber 3200 to the surroundings when the pressure inside the plenum chamber is positive relative to the surroundings. The vent 3400 is configured to maintain the therapeutic pressure inside the plenum chamber during use, while ensuring that the airflow is large enough to reduce patient rebreathing of exhaled CO2.

[0345] One form of the ventilation section 3400 according to this technology includes a plurality of holes, for example, about 5 to about 100 holes, about 10 to about 90 holes, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0346] The ventilation section 3400 may be located within the plenum chamber 3200. Alternatively, the ventilation section 3400 may be located within a release structure, such as a swivel. The ventilation section of the plenum chamber 9110 is also shown in Figure 9E.

[0347] The vent 9080 may be integrated with the headgear. For example, the vent 9080 may be positioned close to the headgear outlet 9030. The vent 9080 may also be positioned close to the plenum chamber 9110. The vent 9080 may be part of the headgear tubing 9060.

[0348] In this way, the gas exhaled by the patient can be released into the surroundings through the vent. The vent is appropriately sized and shaped to maintain the therapeutic pressure within the plenum chamber 9110 during use. Advantageously, integrating the vent with the headgear tubing allows for the expulsion of excess pressurized air in addition to carbon dioxide, enabling more precise control of airflow to the patient's nostrils. This combination also allows for a more compact headgear design. 5.3.6 Uncoupling structure

[0349] In one embodiment, the patient interface 3000 includes at least one decoupling structure (e.g., a swivel or bulbolar fovea). 5.3.7 Connection Ports

[0350] Connection port 3600 allows connection to the air circuit 4170. 5.3.8 Forehead support

[0351] In one embodiment, the patient interface 3000 includes a forehead support portion 3700. 5.3.9 Suffocation prevention valve

[0352] In one embodiment, the patient interface 3000 includes an asphyxiation prevention valve. 5.3.10 Ports

[0353] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one embodiment, this enables a clinician to supply supplemental oxygen. In one embodiment, this enables direct measurement of the properties of the gas (e.g., pressure) within the plenum chamber 3200. 5.4 RPT Devices

[0354] An RPT device 4000 according to one aspect of this technology comprises mechanical, pneumatic, and / or electrical components and is configured to perform one or more algorithms 4300 (e.g., any of the methods described herein, either entirely or in part). The RPT device 4000 may be configured to generate an airflow delivered to the patient's airway for the treatment of one or more respiratory conditions described, for example, any of those described herein. The RPT device may include a headgear and / or patient interface disclosed herein.

[0355] In one embodiment, the RPT device 4000 is constructed and positioned to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, at least 10 cmH2O, or at least 20 cmH2O.

[0356] The RPT device may have an external housing 4010. The external housing 4010 is formed by two parts, an upper part 4012 and a lower part 4014. Furthermore, the external housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0357] The pneumatic path of the RPT device 4000 may include one or more air path items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) and one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0358] One or more of the air passage items may be housed within a removable, integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be housed within an external housing 4010. In one embodiment, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0359] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller 4230, a therapeutic device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In one alternative configuration, the RPT device 4000 may include more than one PCBA 4202. 5.4.1 Mechanical and pneumatic components of RPT devices

[0360] An RPT device may include one or more of the following components in a single unit. In one alternative configuration, one or more of the following components may be arranged as separate units. 5.4.1.1 Air Filter

[0361] An RPT device according to one embodiment of this technology may include an air filter 4110 or a plurality of air filters 4110.

[0362] In one embodiment, the inlet air filter 4112 is positioned at the beginning of the upstream air pressure path of the pressure generator 4140.

[0363] In one embodiment, the outlet air filter 4114 (e.g., antimicrobial factor) is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800. 5.4.1.2 Muffler

[0364] An RPT device according to one embodiment of this technology may include a muffler 4120 or a plurality of mufflers 4120.

[0365] In one embodiment of this technology, the inlet muffler 4122 is located upstream of the pressure generator 4140 in the pneumatic path.

[0366] In one embodiment of this technology, the outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800. 5.4.1.3 Pressure Generator

[0367] In one embodiment of this technology, a pressure generator 4140 that generates an airflow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be located within a volute. The blower can deliver an air supply at a rate of, for example, up to about 120 liters / minute at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other embodiments up to about 30 cmH2O, when respiratory pressure therapy is being administered. The blower may be described in any one of the following patents or patent applications, the contents of which are incorporated herein by reference in whole: U.S. Patent No. 7,866,944, U.S. Patent No. 8,638,014, U.S. Patent No. 8,636,479, and International Publication No. 2013 / 020167.

[0368] The pressure generator 4140 may be under the control of the treatment device controller 4240.

[0369] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows. 5.4.1.4 Converter

[0370] The transducer may be located inside the RPT device or outside the RPT device. The external transducer may be located, for example, on an air circuit or may form part of an air circuit (e.g., a patient interface). The external transducer may be in the form of a non-contact sensor, such as a Doppler radar motion sensor, that transmits or transfers data to the RPT device.

[0371] In one embodiment of this technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and positioned to generate signals that describe the characteristics of the airflow (e.g., flow rate, pressure, or temperature at that point in the pneumatic path).

[0372] In one embodiment of this technology, one or more transducers 4270 may be located near the patient interface 3000 or 3800.

[0373] In one embodiment, the signal from the converter 4270 may be filtered, for example, by low-pass, high-pass, or band-pass filtering. 5.4.1.4.1 Flow Sensor

[0374] The flow sensor using this technology may be based on a differential pressure transducer, such as the SDP600 series differential pressure transducer from Sensirion Corporation.

[0375] In one configuration, the signal generated by the flow sensor, which represents the flow rate, is received by a central controller. 5.4.1.4.2 Pressure Sensor

[0376] The pressure sensor using this technology is located in communication with both the pneumatic path and the fluid. A suitable example of a pressure sensor is the Honeywell ASDX series transducer. An alternative suitable pressure sensor is the General Electric NPA series transducer.

[0377] In one configuration, the pressure signal generated by the pressure sensor and representing the pressure is received by a central controller. 5.4.1.4.3 Motor Speed ​​Converter

[0378] In one embodiment of this technology, a motor speed converter may be used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed converter may be provided to the treatment device controller 4240. The motor speed converter may be a speed sensor, such as a Hall effect sensor. 5.4.1.5 Anti-spillback valve

[0379] In one embodiment of this technology, the anti-spillback valve 4160 may be located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000, for example, to the blower motor 4144. 5.4.2 RPT Device Electrical Components 5.4.2.1 Power supply

[0380] The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.

[0381] In one embodiment of this technology, the power supply 4210 supplies power only to the RPT device 4000. In another embodiment of this technology, the power supply 4210 supplies power to both the RPT device 4000 and the humidifier 5000. 5.4.2.2 Input Devices

[0382] In one embodiment of this technology, the RPT device 4000 includes one or more input devices, which are in the form of buttons, switches, or dials, for enabling a person to interact with the device. The buttons, switches, or dials may be physical or software devices accessible via a touchscreen. In one embodiment, the buttons, switches, or dials may be physically connected to an external housing 4010, or in another embodiment, they may be wirelessly connected to a receiver electrically connected to a central controller.

[0383] In one form, the input device may be constructed and configured to allow a person to select values ​​and / or menu options. 5.4.2.3 Central Controller

[0384] In one embodiment of this technology, the central controller is one or more processors suitable for controlling the RPT device 4000.

[0385] Suitable processors may include x86 Intel processors, such as STMicroelectronics' STM32 series microcontrollers, which are based on ARM Holdings' ARM® Cortex®-M processors. In certain alternative forms of this technology, 32-bit RISC CPUs such as STMicroelectronics' STR9 series microcontrollers, or 16-bit RISC CPUs such as the MSP430 family of microcontrollers manufactured by Texas Instruments, are also suitable.

[0386] In one form of this technology, the central controller is a dedicated electronic circuit.

[0387] In one embodiment, the central controller is an application-specific integrated circuit. In another embodiment, the central controller comprises individual electronic components.

[0388] The central controller may be configured to receive input signals from one or more transducers 4270, one or more input devices, and a humidifier 5000.

[0389] The central controller may be configured to provide output signals to one or more of the output devices, treatment device controllers, data communication interfaces, and humidifiers 5000.

[0390] In some forms of this technology, the central controller is configured to implement one or more methodologies described herein, such as one or more algorithms that can be implemented by processor control instructions, and is represented as a computer program stored in a temporary computer-readable storage medium such as memory. In some forms of this technology, the central controller may be integrated with the RPT device 4000. However, in some forms of this technology, some methodologies may be implemented by a remotely located device. For example, a remotely located device may determine the control settings of a ventilator or detect respiratory-related events by analyzing stored data, such as from one of the sensors described herein. 5.4.2.4 Clocks

[0391] The RPT device 4000 may include a clock connected to a central controller. 5.4.2.5 Therapeutic device controllers

[0392] In one embodiment of this technology, the therapeutic device controller is a therapeutic control module that forms part of the algorithm executed by the central controller.

[0393] In one embodiment of this technology, the treatment device controller is a dedicated motor control integrated circuit. For example, in one embodiment, an ON Semiconductor MC33035 brushless DC motor controller is used. 5.4.2.6 Protection circuit

[0394] One or more protection circuits provided by this technology may include electrical protection circuits, temperature and / or pressure safety circuits. 5.4.2.7 Memory

[0395] According to one embodiment of this technology, the RPT device 4000 includes memory, for example, non-volatile memory. In some embodiments, the memory may include battery-powered static RAM. In some embodiments, the memory may include volatile RAM.

[0396] Memory 4260 may be located on PCBA4202. The memory may be in the form of EEPROM or NAND flash.

[0397] In addition, or instead, the RPT device 4000 may include removable memory, such as a memory card made in accordance with the Secure Digital (SD) standard.

[0398] In one embodiment of this technology, the memory functions as a non-temporary, computer-readable storage medium that stores computer program instructions representing one or more methodologies described herein, such as one or more algorithms. 5.4.2.8 Data Communication System

[0399] In one embodiment of this technology, a data communication interface is provided and connected to a central controller. The data communication interface may be connectable to a remote external communication network and / or a local external communication network. The remote external communication network may be connectable to a remote external device 4286. The local external communication network may be connectable to a local external device.

[0400] In one embodiment, the data communication interface is part of the central controller. In another embodiment, the data communication interface is separate from the central controller and may include an integrated circuit or processor.

[0401] In one form, the remote external communication network is the Internet. The data communication interface connects to the Internet using wired communication (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE).

[0402] In one configuration, the local external communication network utilizes one or more communication standards, such as Bluetooth® or the Consumer Infrared Protocol.

[0403] In one form, the remote external device is one or more computers, such as a cluster of networked computers. In another form, the remote external device may be a virtual computer rather than a physical computer. In either case, such a remote external device may be accessible to appropriately authorized persons, such as clinicians.

[0404] The local external device may be a personal computer, mobile phone, tablet, or remote control. 5.4.2.9 Output devices including any display or alarm

[0405] The output device using this technology may take the form of one or more of visual, auditory, and tactile units. The visual display may be a liquid crystal display (LCD) or a light-emitting diode (LED) display. 5.4.2.9.1 Display Driver

[0406] The display driver receives characters, symbols, or images to be displayed on the display as input and converts them into commands that cause the display to show those characters, symbols, or images. 5.4.2.9.2 Display

[0407] A display is configured to visually display characters, symbols, or images in response to commands received from a display driver. For example, a display may be an 8-segment display if the display driver translates each character or symbol, such as the digit "0", into eight logical signals that indicate whether each of the eight segments is activated to display a particular character or symbol. 5.5 Air Circuit

[0408] An air circuit 4170 according to one aspect of this technology is a conduit or tube constructed and positioned so that, during use, airflow can move between two components, such as an RPT device 4000 and a patient interface 3000 or 3800.

[0409] In particular, the air circuit 4170 may be fluidly connected to the pneumatic block 4020 and the outlet of the patient interface. The air circuit may also be called an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0410] In some embodiments, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example, to maintain or increase the air temperature. The heating elements may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one embodiment, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating elements may communicate with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety. 5.5.1 Auxiliary gas supply

[0411] In one embodiment of this technology, an auxiliary gas 4180, such as oxygen, is delivered to one or more points in the pneumatic pathway, for example, upstream of the pneumatic block 4020, the air circuit 4170, and / or the patient interface 3000 or 3800. 5.6 Humidifier 5.6.1 Overview of Humidifiers

[0412] In one embodiment of this technology, a humidifier 5000 is provided for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air (for example, as shown in Figure 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to the ambient air) and temperature of the airflow before it is delivered to the patient's airway.

[0413] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 that receives airflow, and a humidifier outlet 5004 that delivers humidified airflow. In some embodiments, as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may receive the humidifier reservoir 5110 and be adapted to include a heating element 5240. 5.6.2 Humidifier components 5.6.2.1 Water Reservoir

[0414] In one configuration, the humidifier 5000 may include a water reservoir 5110 configured to hold or retain a volume of a certain amount of liquid (e.g., water) to be evaporated for humidifying the airflow. The water reservoir 5110 is configured to hold a predetermined maximum amount of water to provide adequate humidification for at least the duration of a respiratory therapy session, such as an overnight sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 milliliters (ml), 325 ml, 350 ml, or 400 ml. In another configuration, the humidifier 5000 may be configured to receive water from an external water source, such as a building's water supply system.

[0415] In one embodiment, the water reservoir 5110 is configured to add humidity to the airflow from the RPT device 4000 as the airflow moves through it. In one embodiment, the water reservoir 5110 may be configured to facilitate the airflow moving through the reservoir 5110 in a winding path while in contact with the volume of water therein.

[0416] In one embodiment, the reservoir 5110 may be removable laterally from the humidifier 5000, for example, as shown in Figures 5A and 5B.

[0417] The reservoir 5110 may also be configured to prevent liquid from flowing out therein, for example, if the reservoir 5110 is displaced and / or rotated from its normal working direction through any opening and / or between its subcomponents. Since the airflow humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent leakage and / or loss of air pressure due to flow impedance. 5.6.2.2 Conductive portion

[0418] In one configuration, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the volume of liquid in the reservoir 5110. In one embodiment, the conductive portion 5120 may be arranged as a plate, but other shapes may also be appropriate. All or part of the conductive portion 5120 may be made of a thermally conductive material such as aluminum (for example, approximately 2 mm thick, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastic. In some cases, a suitable thermal conductivity can be achieved by using a less conductive material in a suitable shape. 5.6.2.3 Humidifier reservoir dock

[0419] In one embodiment, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in Figure 5B) configured to receive a humidifier reservoir 5110. In some configurations, the humidifier reservoir dock 5130 may include a locking mechanism, such as a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130. 5.6.2.4 Water Level Indicator

[0420] The humidifier reservoir 5110 may include a water level indicator 5150, as shown in Figures 5A-5B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as a patient or caregiver, regarding the volume of water in the humidifier reservoir 5110. One or more indications provided by the water level indicator 5150 may include a maximum predetermined amount of water, any portion thereof such as 25%, 50%, or 75%, or a volume indication such as 200 ml, 300 ml, or 400 ml. 5.6.2.5 Humidifier Converter

[0421] The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of, or in addition to, the transducer 4270 described above. The humidifier transducer 5210 may include one or more of the following: an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218, as shown in Figure 5C. The humidifier transducer 5210 may generate one or more output signals that can be transmitted to a controller such as a central controller 4230 and / or a humidifier controller 5250. In some forms, the humidifier transducer may be located outside the humidifier 5000 (e.g., in the air circuit 4170) while communicating the output signals to the controller. 5.6.2.5.1 Pressure Converter

[0422] In addition to the pressure sensor 4272 provided on the RPT device 4000, or instead, one or more pressure transducers 5212 may be provided on the humidifier 5000. 5.6.2.5.2 Flow Converter

[0423] In addition to the flow sensor 4274 provided on the RPT device 4000, or instead, one or more flow converters 5214 may be provided on the humidifier 5000. 5.6.2.5.3 Temperature Converter

[0424] The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures, such as the heating element 5240 and / or the airflow downstream of the humidifier outlet 5004. In some embodiments, the humidifier 5000 may further include a temperature sensor 5216 for detecting the temperature of the ambient air. 5.6.2.5.4 Humidity Converter

[0425] In one embodiment, the humidifier 5000 may include one or more humidity sensors 5218 for detecting the humidity of a gas, such as ambient air. The humidity sensors 5218 may be positioned toward the humidifier outlet 5004 in some embodiments for measuring the humidity of the gas delivered from the humidifier 5000. The humidity sensors may be absolute humidity sensors or relative humidity sensors. 5.6.2.6 Heating elements

[0426] The heating element 5240 may optionally be provided in the humidifier 5000 to provide heat input to one or more of the volume of water and / or airflow in the humidifier reservoir 5110. The heating element 5240 may include heat-generating components such as an electrical resistance heating track. One suitable example of the heating element 5240 is a layered heating element, such as that described in International Publication No. 2012 / 171072, which is incorporated herein by reference in its entirety.

[0427] In some embodiments, the heating element 5240 may be located within a humidifier base 5006, as shown in Figure 5B, where heat can be supplied to the humidifier reservoir 5110 primarily by conduction. 5.6.2.7 Humidifier Controller

[0428] In one configuration of this technology, the humidifier 5000 may include a humidifier controller 5250, as shown in Figure 5C. In one embodiment, the humidifier controller 5250 may be part of a central controller 4230. In another embodiment, the humidifier controller 5250 may be a separate controller that communicates with the central controller 4230.

[0429] In one embodiment, the humidifier controller 5250 may accept, for example, measures of airflow, water in the reservoir 5110, and / or characteristics of the humidifier 5000 (such as temperature, humidity, pressure, and / or flow rate) as input. The humidifier controller 5250 may also be configured to run or implement a humidifier algorithm and / or deliver one or more output signals.

[0430] As shown in Figure 5C, the humidifier controller 5250 may include one or more controllers, such as a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heated element controller 5252 configured to control the temperature of the heated element 5240. 5.7 Respiratory waveform

[0431] Figure 6A shows a model of a typical human respiratory waveform during sleep. The horizontal axis represents time, and the vertical axis represents respiratory flow rate. Since parameter values ​​can vary, typical respiration can have the following approximate values: Tidal volume Vt is 0.5 L, inspiratory time Ti is 1.6 sec, peak inspiratory flow rate Q is 0.4 L / sec, expiratory time Te is 2.4 sec, and peak expiratory flow rate Q is -0.5 L / sec. The total duration of respiration Ttot is approximately 4 seconds. Humans typically breathe about 15 times per minute (BPM), and ventilation Vent is approximately 7.5 L / min. In a typical load cycle, the ratio of Ti to Ttot is approximately 40%. 5.8 Screening, diagnostic, and monitoring systems 5.8.1 Sleep Polysomnography

[0432] Figure 7A shows patient 1000 undergoing polysomnography (PSG). The PSG system includes a headbox 2000 that receives and records signals from the following sensors: EOG electrode 2015, EEG electrode 2020, ECG electrode 2025, submental EMG electrode 2030, snoring sensor 2035, respiratory inductance plethysmogram (respiratory effort sensor) 2040 on a chest band, respiratory inductance plethysmogram (respiratory effort sensor) 2045 on an abdominal band, oronasal cannula 2050 with oral thermistor, photoplethysmograph (pulse oximeter) 2055, and position sensor 2060. The electrical signals refer to the ground electrode (ISOG) 2010 positioned in the center of the forehead. 5.8.2 Unobtrusive monitoring system

[0433] Figure 7B shows an example of a monitoring device 7100 for monitoring the respiration of a sleeping patient 1000. The monitoring device 7100 generally includes a non-contact motion sensor directed towards the patient 1000. The motion sensor is configured to generate one or more signals representing the body movements of the patient 1000, from which a signal representing the patient's respiratory movements can be obtained. 5.8.3 Respiratory Polysomnography

[0434] Respiratory polysomnography (RPG) is a term used to describe a simplified form of PSG without electrical signal (EOG, EEG, EMG) sensors, snoring sensors, or positional sensors. Typically, RPG includes at least chest movement signals from a respiratory inductance plethysmogram (motion sensor) of a chest band, e.g., motion sensor 2040, nasal pressure signals sensed via a nasal cannula, and oxygen saturation signals from a pulse oximeter, e.g., pulse oximeter 2055. The three RPG signals or channels are received by an RPG headbox similar to the PSG headbox 2000.

[0435] In certain configurations, the nasal pressure signal is a good proxy for the nasal flow signal produced by a sealed nasal mask and an in-line flow transducer, in that the nasal pressure signal is similar in shape to the nasal flow signal. Similarly, the nasal flow is equal to the airflow when the patient's mouth remains closed, i.e., when there is no leakage from the mouth.

[0436] Figure 7C is a block diagram showing a screening / diagnostic / monitoring device 7200 that may be used to implement an RPG headbox in an RPG screening / diagnostic / monitoring system. The screening / diagnostic / monitoring device 7200 receives the three RPG channels described above (signals indicating chest wall movement, signals indicating nasal flow, and signals indicating oxygen saturation) at a data input interface 7260. The screening / diagnostic / monitoring device 7200 also includes a processor 7210 configured to execute encoded instructions. The screening / diagnostic / monitoring device 7200 also includes a non-temporary computer-readable memory / storage medium 7230.

[0437] Memory 7230 may be the internal memory of the screening / diagnostic / monitoring device 7200, such as RAM, flash memory, or ROM. In some implementations, memory 7230 may be removable or external memory linked to the screening / diagnostic / monitoring device 7200, such as an SD card, server, USB flash drive, or optical disc. In other implementations, memory 7230 may be a combination of external and internal memory. Memory 7230 includes stored data 7240 and processor control instructions (codes) 7250 adapted to configure the processor 7210 to perform a specific task. Stored data 7240 may include RPG channel data received by the data input interface 7260 and other data provided as a component part of an application. Processor control instructions 7250 may also be provided as a component part of an application program. The processor 7210 is configured to read the code 7250 from memory 7230 and execute the encoded instructions. In particular, code 7250 may include instructions adapted to configure processor 7210 to perform a method of processing RPG channel data provided by interface 7260. One such method may be to store the RPG channel data as data 7240 in memory 7230. Another such method may be to analyze the stored RPG data to extract features. Processor 7210 may store the results of such analysis as data 7240 in memory 7230.

[0438] The screening / diagnostic / monitoring device 7200 may also include a communication interface 7220. Code 7250 may include instructions configured to enable the processor 7210 to communicate with an external computing device (not shown) via the communication interface 7220. The communication method may be wired or wireless. In one such implementation, the processor 7210 may transmit stored RPG channel data from data 7240 to a remote computing device. In such an implementation, the remote computing device may be configured to analyze the received RPG data and extract features. In another such implementation, the processor 7210 may transmit the results of the analysis from data 7240 to the remote computing device.

[0439] Alternatively, if the memory 7230 is detachable from the screening / diagnostic / monitoring device 7200, the remote computing device may be configured to connect to the detachable memory 7230. In such an implementation, the remote computing device may be configured to analyze RPG data retrieved from the detachable memory 7230 to extract features. 5.9 Portable Oxygen Concentrator (POC)

[0440] A portable oxygen concentrator may utilize the pressure swing adsorption method (PSA). In the pressure swing adsorption method, one or more compressors can be used to increase the gas pressure in a canister containing particles of a gas separation adsorbent provided in a "sieve bed". As the pressure increases, specific molecules in the gas may be adsorbed onto the gas separation adsorbent. When a portion of the gas in the canister is removed under pressurized conditions, unadsorbed molecules are separated from the adsorbed molecules. The gas separation adsorbent can be regenerated by reducing the pressure, resulting in a reversal of molecular adsorption from the adsorbent. Further details regarding the oxygen concentrator can be found, for example, in U.S. Patent Application Publication No. 2009-0065007, entitled "Oxygen Concentrator and Method," published on March 12, 2009, which is incorporated herein by reference.

[0441] Ambient air typically contains approximately 78% nitrogen and 21% oxygen, with argon, carbon dioxide, water vapor, and other trace gases making up the balance. When a gas mixture, such as air, is passed under pressure through a canister containing a gas separation adsorbent bed that adsorbs nitrogen more than oxygen, some or all of the nitrogen remains in the bed, while the gas exiting the canister becomes oxygen-rich. When the bed reaches its nitrogen adsorption limit, the bed can be regenerated by reducing the pressure, thereby releasing the adsorbed nitrogen. The system is then ready for another oxygen-enriched air generation cycle. By using canisters in a two-canister system alternately, oxygen can be separated in one canister and the other canister purged (resulting in continuous oxygen separation from nitrogen). In this way, oxygen-enriched air can be stored, for example, in a storage container or other pressurized container or conduit connected to the canister, for various applications such as supplying supplemental oxygen to patients. 5.10 Respiratory Therapy Mode

[0442] The disclosed respiratory therapy system allows for the implementation of various respiratory therapy modes. 5.10.1 CPAP therapy

[0443] In some implementations of respiratory pressure therapy, the central controller 4230 sets the therapeutic pressure Pt according to the therapeutic pressure formula as part of the therapeutic parameter determination algorithm 4329. The formula for pressure therapy (1) is Pt = AΠ(Φ,t) + P0, where A is the amplitude, Π(Φ,t) is the current phase value Φ and the waveform template value (in the range of 0 to 1) at time t, and P0 is the base pressure. In one such implementation, since the amplitude A is equal to zero, the therapeutic pressure Pt (representing the target value achieved by the interface pressure Pm at this moment) is exactly equal to the base pressure P0 for the entire respiratory cycle. Such implementations are generally grouped under the title of CPAP therapy. In such implementations, the therapeutic engine module 4320 does not need to determine the phase Φ or the waveform template Π(Φ).

[0444] In CPAP therapy, the base pressure P0 may be a constant value hardcoded in the RPT device 4000 or manually entered. Alternatively, the central controller 4230 may iteratively calculate the base pressure P0 as a function of an index or measure of sleep-disordered breathing returned by each algorithm of the treatment engine module 4320, such as flow limitation, apnea, hypopnea, patency, or snoring. This alternative is sometimes called APAP therapy.

[0445] Figure 4E is a flowchart showing how method 4500 is performed by the central controller 4230 to continuously calculate the base pressure P0 as part of the implementation form of APAP treatment of the treatment parameter determination algorithm 4329 when pressure assist A is equal to zero.

[0446] Method 4500 begins in step 4520, in which the central controller 4230 compares a measure of the presence of apnea / hypopnea to a first threshold and determines whether the measure of the presence of apnea / hypopnea has exceeded the first threshold indicating that apnea / hypopnea has occurred for a given period of time. If so, Method 4500 proceeds to step 4540; otherwise, Method 4500 proceeds to step 4530. In step 4540, the central controller 4230 compares a measure of airway patency to a second threshold. If the measure of airway patency exceeds the second threshold indicating that the airway is patent, the detected apnea / hypopnea is considered central and Method 4500 proceeds to step 4560; otherwise, the apnea / hypopnea is considered obstructive and Method 4500 proceeds to step 4550.

[0447] In step 4530, the central controller 4230 compares the flow limiting measure to a third threshold. If the flow limiting measure exceeds the third threshold indicating that the inspiratory flow is limited, method 4500 proceeds to step 4550; otherwise, method 4500 proceeds to step 4560.

[0448] In step 4550, the central controller 4230 increases the base pressure P0 by a predetermined pressure increment ΔP, but the resulting therapeutic pressure Pt does not exceed the maximum therapeutic pressure Pmax. In one implementation, the predetermined pressure increment ΔP and the maximum therapeutic pressure Pmax are 1 cmH2O and 25 cmH2O, respectively. In other implementations, the pressure increment ΔP may be as low as 0.1 cmH2O and as high as 3 cmH2O, or as low as 0.5 cmH2O and as high as 2 cmH2O. In other implementations, the maximum therapeutic pressure Pmax may be as low as 15 cmH2O and as high as 35 cmH2O, or as low as 20 cmH2O and as high as 30 cmH2O. Method 4500 then returns to step 4520.

[0449] In step 4560, the central controller 4230 reduces the base pressure P0 by a certain amount, but the reduced base pressure P0 does not fall below the minimum therapeutic pressure Pmin. Method 4500 then returns to step 4520. In one implementation, since the reduction is proportional to the value of P0-Pmin, the decrease of P0 to the minimum therapeutic pressure Pmin when no event is detected is exponential. In one implementation, the proportionality constant is set such that the time constant τ for the exponential decrease of P0 is 60 minutes and the minimum therapeutic pressure Pmin is 4 cmH2O. In other implementations, the time constant τ may be as low as 1 minute and as high as 300 minutes, or as low as 5 minutes and as high as 180 minutes. In other implementations, the minimum therapeutic pressure Pmin may be as low as 0 cmH2O and as high as 8 cmH2O, or as low as 2 cmH2O and as high as 6 cmH2O. Alternatively, since the decrease in P0 can be determined in advance, the decrease in P0 to the minimum therapeutic pressure Pmin when no events are detected is linear. 5.10.2 Bilevel Therapy

[0450] In other implementations of this technology, the value of amplitude A in equation (1) can be positive. When determining the therapeutic pressure Pt using equation (1) with a positive amplitude A, the therapeutic parameter determination algorithm 4329 varies the therapeutic pressure Pt between two values ​​or levels in synchronization with the spontaneous respiratory effort of patient 1000, and this implementation is known as bilevel therapy. That is, based on the typical waveform template Π(Φ,t) described above, the therapeutic parameter determination algorithm 4329 increases the therapeutic pressure Pt to P0+A (known as IPAP) at the start of inspiration or during inspiration, and decreases the therapeutic pressure Pt to the base pressure P0 (known as EPAP) at the start of expiration or during expiration.

[0451] In some forms of bilevel therapy, IPAP is a therapeutic pressure with the same purpose as the therapeutic pressure in CPAP therapy mode, while EPAP is IPAP minus amplitude A, and has a “smaller” value (a few cmH2O) sometimes called expiratory pressure reduction (EPR). Such forms are sometimes called CPAP therapy with EPR and are generally considered more comfortable than straight CPAP therapy. In CPAP therapy with EPR, either or both IPAP and EPAP can be constant values ​​hardcoded in the RPT device 4000 or manually entered. Alternatively, the therapy parameter determination algorithm 4329 may iteratively calculate IPAP and / or EPAP during CPAP with EPR. In this alternative, the therapy parameter determination algorithm 4329 iteratively calculates EPAP and / or IPAP as a function of the exponential or measure of sleep-disordered breathing returned by the respective algorithms in the therapy engine module 4320, in a manner similar to the calculation of base pressure P0 in APAP therapy described above.

[0452] In other forms of bilevel therapy, the amplitude A is large enough for the RPT device 4000 to perform some or all of the patient's breathing work. In such forms known as pressure-assisted ventilation, the amplitude A is called pressure assist or swing. In pressure-assisted ventilation, IPAP is the base pressure P0 plus pressure assist A, while EPAP is the base pressure P0.

[0453] In some forms of pressure-assisted ventilation, known as fixed-pressure assisted ventilation, the pressure assist A is fixed to a predetermined value, for example, 10 cmH2O. The predetermined pressure assist value is a setting of the RPT device 4000, which can be set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input via the input device 4220.

[0454] In other forms of pressure-assisted ventilation therapy, widely known as servo ventilation, the treatment parameter determination algorithm 4329 takes as input some of the currently measured or estimated respiratory cycle parameters (e.g., current measurement of ventilation Vent) and the target value of that respiratory parameter (e.g., target value of ventilation Vtgt), and iteratively adjusts the parameters of equation (1) to bring the current measurement of the respiratory parameter to the target value. In a form of servo ventilation known as adaptive servo ventilation (ASV), which has been used to treat CSR, the respiratory parameter is ventilation, and the target ventilation value Vtgt is calculated by the target ventilation determination algorithm 4328 from the typical recent ventilation Vtyp described above.

[0455] In some forms of servo ventilation, the treatment parameter determination algorithm 4329 applies a control methodology to iteratively calculate pressure assist A to bring the current measurement of respiratory parameters to target values. One such control method is proportional-integral (PI) control. In one implementation of PI control suitable for ASV mode where the target ventilation Vtgt is set slightly lower than a typical recent ventilation Vtyp, pressure assist A is iteratively calculated as follows:

[0456]

number

[0457] Here, G is the gain of PI control. A larger gain G may result in positive feedback in the treatment engine module 4320. A smaller gain G may leave some untreated CSR or central sleep apnea. In some implementations, the gain G is fixed at a predetermined value, such as -0.4 cmH2O / (L / min) / sec. Alternatively, the gain G may vary between treatment sessions, starting small and increasing session by session until it reaches a value that substantially eliminates CSR. Conventional methods for retrospectively analyzing treatment session parameters to assess the severity of CSR during a treatment session may be applied in such implementations. In yet other implementations, the gain G may vary depending on the difference between the current measured ventilation Vent and the target ventilation Vtgt.

[0458] Other servo ventilation control methodologies that can be applied by the treatment parameter determination algorithm 4329 include proportional (P), proportional-derivative (PD), and proportional-integral-derivative (PID).

[0459] The value of pressure assist A calculated via equation (2) may be limited to a range defined as [Amin, Amax]. In this implementation, pressure assist A remains at the minimum pressure assist Amin by default until the current ventilation measurement Vent falls below the target ventilation Vtgt, at which point A begins to increase, returning to Amin only when Vent again exceeds Vtgt.

[0460] The pressure assist limits Amin and Amax are settings of the RPT device 4000, which are set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input via the input device 4220.

[0461] In pressure-assisted ventilation therapy mode, EPAP is the base pressure P0. Similar to the base pressure P0 in CPAP therapy, EPAP can be a constant value defined or determined during titration. Such a constant EPAP can be set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input via the input device 4220. This alternative is sometimes called fixed EPAP pressure-assisted ventilation therapy. Titration of EPAP for a specific patient may be performed by a clinician during a titration session with the help of PSG for the purpose of preventing obstructive apnea, thereby maintaining airway openness for pressure-assisted ventilation therapy in a manner similar to titration of the base pressure P0 in constant CPAP therapy.

[0462] Alternatively, the treatment parameter determination algorithm 4329 may iteratively calculate the base pressure P0 during pressure-assisted ventilation therapy. In this implementation, the treatment parameter determination algorithm 4329 iteratively calculates EPAP as a function of an index or measure of sleep-disordered breathing returned by each algorithm of the treatment engine module 4320, such as one or more of flow limitation, apnea, hypopnea, patency, and snoring. Because the continuous calculation of EPAP is similar to the manual adjustment of EPAP by a clinician during EPAP titration, this process is also called automated titration of EPAP, and the treatment mode is known as automated titrated EPAP pressure-assisted ventilation therapy or automated EPAP pressure-assisted ventilation therapy. 5.10.3 High-flow therapy

[0463] In other forms of respiratory therapy, the pressure of the airflow is not controlled as in respiratory pressure therapy. Rather, the central controller 4230 controls the pressure generator 4140 to deliver an airflow controlled to a therapeutic or target flow rate Qtgt, where the device flow rate Qd is typically positive throughout the patient's respiratory cycle. Such forms are generally grouped under the heading of flow therapy. In flow therapy, the therapeutic flow rate Qtgt may be a constant value hardcoded or manually entered in the RPT device 4000. If the therapeutic flow rate Qtgt is sufficient to exceed the patient's maximum inspiratory flow rate, the therapy is generally called high-flow therapy (HFT). Alternatively, the therapeutic flow rate may be a profile Qtgt(t) that changes over the respiratory cycle. 5.11 Glossary

[0464] For the purposes of disclosing this technology, one or more of the following definitions may apply in certain forms of this technology. Other definitions may also apply in other forms of this technology. 5.11.1 General

[0465] Air: In certain forms of this technology, air may mean the atmosphere, and in other forms of this technology, air may mean a combination of other breathable gases (e.g., oxygen-enriched air).

[0466] Atmosphere: In certain forms of this technology, the term “atmosphere” should be understood to mean (i) the area outside the treatment system or patient, and (ii) the area directly surrounding the treatment system or patient.

[0467] For example, ambient humidity for a humidifier can be the humidity of the air directly surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). This ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0468] In another embodiment, the ambient pressure may be the pressure directly surrounding or outside the body.

[0469] In certain forms, ambient (e.g., acoustic) noise can be considered the background noise level in the patient's room, excluding noise originating from, for example, RPT devices or masks or patient interfaces. Ambient noise may originate from sources outside the room.

[0470] Automatic positive airway pressure (APAP) therapy: CPAP therapy that can automatically adjust the therapeutic pressure between minimum and maximum limits between breaths, for example, depending on the presence or absence of signs of SDB onset.

[0471] Continuous positive airway pressure (CPAP) therapy: Respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway entrance increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure fluctuates between different respiratory cycles of the patient (e.g., increased in response to the detection of signs of partial upper airway obstruction and decreased in the absence of such indications).

[0472] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, when flow rate is mentioned, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, when flow rate is mentioned, it refers to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be denoted by the sign Q. Flow rate is sometimes simply called "flow" or "airflow."

[0473] In the patient's respiratory embodiment, the flow rate can be negative relative to the expiratory portion of the patient's respiratory cycle, as it can be nominally positive relative to the inspiratory portion of the patient's respiratory cycle. Device flow rate Qd is the flow rate of air exiting the RPT device. Total flow rate Qt is the flow rate of air and any auxiliary gases reaching the patient interface through the air circuit. Vent flow rate Qv is the flow rate of air exiting the vent to allow for the expulsion of exhaled gases. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or other locations. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0474] Flow therapy: Respiratory therapy that involves delivering airflow to the airway inlet at a controlled flow rate, usually positive, called therapeutic flow rate, throughout the patient's entire respiratory cycle.

[0475] Humidifier: The term "humidifier" is interpreted as a humidifying device that is constructed, positioned, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor into the airflow to improve a patient's medical respiratory condition.

[0476] Leakage: The term "leakage" is taken to mean an unintended flow of air. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in a swivel elbow relative to the surroundings.

[0477] Conducted Noise (Acoustics): In this document, conducted noise refers to noise transmitted to a patient via pneumatic pathways (e.g., air circuits and patient interfaces and the air within them). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0478] Noise, Radiation (Acoustic): In this document, radiated noise refers to noise transmitted to the patient by the surrounding air. In one form, radiated noise can be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO 3744.

[0479] Noise, Ventilation (Acoustics): In this document, ventilation noise refers to noise generated by airflow through any ventilation (e.g., ventilation holes in a patient interface).

[0480] Oxygen-enriched air: Air with an oxygen concentration higher than the oxygen concentration of the atmosphere (21%) (for example, at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99%). Sometimes "oxygen-enriched air" is simply referred to as "oxygen."

[0481] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0482] Patient: A person who has or does not have a respiratory illness.

[0483] Pressure: Force per unit area. Pressure can be expressed in various units (e.g., cmH2O, gf / cm²). 2 , and hectopascals). 1 cmH2O is 1 g-f / cm 2 This is equivalent to approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m³). 2 (=1 millibar to 0.001 atm). In this specification, unless otherwise specified, pressure is given in units of cmH2O.

[0484] The pressure within the patient interface is denoted by the symbol Pm, and the therapeutic pressure, which represents the target value that the interface pressure Pm should achieve at the current moment, is denoted by the symbol Pt.

[0485] Respiratory pressure therapy: Addition of air supply to the airway inlet at therapeutic pressure, which is typically positive relative to the atmosphere.

[0486] Ventilator: A mechanical device that provides pressure assistance to help a patient perform some or all of the breathing motion. 5.11.1.1 Materials

[0487] Silicone or silicone elastomer: synthetic rubber. In this specification, when silicone is referred to, it means liquid silicone rubber (LSR) or compression-molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the product line sold under this registered trademark), manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified, the Shore A (or Type A) indentation hardness of exemplary forms of LSR, as measured by ASTM D2240, is approximately 35 to approximately 45.

[0488] Polycarbonate is a thermoplastic polymer of bisphenol A carbonate.

[0489] As used herein, “composite material” is a material made from two or more constituent materials. The constituent materials may have very different physical or chemical properties when combined, resulting in a material with properties different from those of the individual components. The individual components remain separated within the finished structure. For example, a composite material may be a multilayer material composed of two or more layers, each layer being a constituent material. Adjacent constituent materials may have different physical or chemical properties, or they may have the same or similar physical or chemical properties. In a further embodiment, each adjacent constituent material has a particle orientation, and the particle orientations of adjacent constituent materials are offset from each other by an angle.

[0490] Fibers: Flexible materials formed from a network of fibers, which may be natural, artificial, or a combination thereof. Fibers (e.g., wool, flax, cotton, hemp, and / or synthetic fibers) are woven, knitted, crocheted, knotted, tatted, felted, and / or knitted into yarns that form fibers. The terms “fiber” and “fabric” as used herein are interchangeable. 5.11.1.2 Mechanical properties

[0491] Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0492] Resilient: Releases virtually all energy upon unloading. Includes, for example, certain silicones and thermoplastic elastomers.

[0493] Hardness: The ability of a material to resist deformation (described, for example, by Young's modulus or indentation hardness scale measured on a standardized sample size). "Flexible" materials may include silicone or thermoplastic elastomer (TPE) and can be easily deformed, for example, under finger pressure. "Hard" materials may include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0494] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation when subjected to a load. The load can be a force or moment, such as compression, extension, bending, or torsion. A structure or component may provide different resistance in different directions. The opposite of stiffness is flexibility.

[0495] Floppy structure or component: A structure or component that changes shape for a relatively short period of time, for example, within one second, when supported by its own weight, such as bending.

[0496] Rigid structure or component: A structure or component that remains substantially unchanged in shape when subjected to loads typically encountered during use. An example of such an application might be setting up and maintaining a patient interface in a sealed state against the patient's airway inlet under a pressure load of, for example, approximately 20-30 cmH2O.

[0497] In one embodiment, an I-beam may have different bending stiffnesses (resistance to bending loads) in the first direction compared to a second orthogonal direction. In another embodiment, a structure or component may be floppy in the first direction and rigid in the second direction.

[0498] Flexural modulus (also called bending modulus): A property calculated as the ratio of stress to strain in bending deformation, or as the tendency of a material to resist bending. The flexural modulus is inversely proportional to deflection; the smaller the deflection, the higher the modulus.

[0499] Young's modulus: A mechanical property used to measure the stiffness of solid materials. It defines the relationship between stress (force per unit area) and strain (proportional deformation) of a material in the linear elastic region of uniaxial deformation. In other words, it is under tensile (expansion) or compressive (compression) stress. 5.11.2 Respiratory cycle

[0500] Apnea: According to some definitions, apnea is said to occur when airflow falls below a certain threshold for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when airflow is not permitted due to some airway obstruction despite the patient's exertion. Central apnea is said to refer to a condition in which apnea is detected due to decreased or absent respiratory effort, even though the airway is open. Mixed apnea is said to refer to a condition in which decreased or absent respiratory effort occurs simultaneously with airway obstruction.

[0501] Respiratory rate: This is the patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0502] Load cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0503] Exercise (breathing): Breathing effort is said to refer to the movements performed by a person's spontaneous breathing.

[0504] The exhalation portion of the respiratory cycle: the period from the start of the exhalation flow to the start of the inhalation flow.

[0505] Flow limitation: Flow limitation is interpreted as a situation in a patient's respiration where increased exertion by the patient does not result in a corresponding increase in flow rate. If flow limitation occurs during the inspiratory portion of the respiratory cycle, it may be referred to as inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, it may be referred to as expiratory flow limitation.

[0506] Types of waveforms for flow-restricted inspiratory air: (i) Flattening: A period of rising followed by a relatively flat section, after which a descent occurs. (ii) M-shaped: It has two local peaks, one at the rising edge and one at the falling edge, with a relatively flat area between these two peaks. (iii) Chair-shaped: Has a single localized peak, which rises and develops at the edge, followed by a relatively flat area. (iv) Inverted chair shape: A relatively flat area is followed by a single localized peak, which then slopes down and develops at the edge.

[0507] Hypopnea: According to some definitions, hypopnea refers to a decrease in flow, rather than an interruption of flow. In a given morphology, hypopnea is said to have occurred if a decrease in flow below a threshold velocity persists for an extended period. If hypopnea is detected due to a decrease in respiratory effort, it is said to have occurred. In a given morphology of an adult, hypopnea may be considered to have occurred if any of the following occurs: (i) A 30% decrease in patient respiration lasting at least 10 seconds + associated 4% desaturation, or (ii) The patient's respiration decreases by less than 50% for at least 10 seconds, and associated desaturation is at least 3% or awakening occurs.

[0508] Hyperventilation: A condition in which blood flow increases to a level higher than normal.

[0509] The inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0510] Airway patency: The degree to which the airway is open or the extent to which the airway is open. Airway patency is defined as opening. Airway patency can be quantified, for example, using a value of (1) indicating patency and a value of (0) indicating closure (obstruction).

[0511] Positive end-expiratory pressure (PEEP): This is the pressure that exceeds the atmospheric pressure in the lungs and is present at the end of exhalation.

[0512] Peak flow rate (Qpeak): The maximum value of the flow rate during the inspiratory portion of the respiratory flow waveform.

[0513] Respiratory airflow, patient airflow rate, respiratory airflow rate (Qr): These terms may be understood to refer to the estimation of respiratory airflow by an RPT device and are used in contrast to "true respiratory flow rate" or "true respiratory airflow rate," which is the patient's actual respiratory flow rate, usually expressed in liters / minute.

[0514] Tidal volume (Vt): This is the amount of air inhaled or exhaled during normal breathing without extra effort. In principle, since inspiratory volume Vi (amount of air inhaled) is equal to expiratory volume Ve (amount of air exhaled), a single tidal volume Vt can be defined as being equal to either of these amounts. In practice, tidal volume Vt is estimated as some combination (for example, the average of inspiratory volume Vi and expiratory volume Ve).

[0515] Inhalation time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0516] Expiratory time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0517] Total time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0518] Typical recent ventilation: Ventilation values ​​where recent ventilation values ​​tend to cluster together over a given timescale (i.e., the degree of the clustering of recent ventilation values).

[0519] Upper airway obstruction (UAO): Includes both partial and total upper airway obstruction. It may be associated with flow-limiting conditions in which flow rate may slightly increase or decrease with increasing pressure differences over the upper airway (Stirling register behavior).

[0520] Ventilation: Measurement of the rate of gas exchange performed by the patient's respiratory system. Ventilation measurements may include either or both of the inspiratory and expiratory airflow per unit time. When expressed as volume per minute, this amount is often called "minute ventilation." Minute ventilation may also simply be given as a volume and understood as volume per minute. 5.11.3 Ventilation

[0521] Adaptive servo ventilators (ASVs): Servo ventilators with a changeable target ventilation rather than a fixed target ventilation. The changeable target ventilation can be learned from some patient characteristic (e.g., the patient's respiratory characteristics).

[0522] Backup rate: A ventilator parameter that establishes the minimum respiratory rate (typically respiratory rate per minute) delivered from the ventilator to the patient (when not triggered by spontaneous respiratory effort).

[0523] Cycle: The end of the inspiratory phase of a ventilator. When a ventilator delivers air to a patient who is breathing spontaneously, it is said that the ventilator cycles to stop delivering air at the end of the inspiratory portion of the respiratory cycle.

[0524] Positive expiratory airway pressure (EPAP): Base pressure to which varying pressures within respiration are added in order to generate the desired interface pressure that the ventilator attempts to achieve at a given time.

[0525] End-of-Expiratory Pressure (EEP): The desired interface pressure that the ventilator aims to achieve at the end of the expiratory portion of respiration. When the pressure waveform template Π(Φ) is zero at the end of exhalation (i.e., Π(Φ)=0 when Φ=1), EEP is equal to EPAP.

[0526] Positive inspiratory airway pressure (IPAP): The maximum desired interface pressure that a ventilator attempts to achieve during the inspiratory portion of breathing.

[0527] Pressure assist: A number indicating the pressure increase during exhalation of a ventilator from the inspiratory phase, primarily representing the pressure difference between the maximum inspiratory pressure and the baseline pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure assist refers to the difference the ventilator aims to achieve (not the difference the ventilator actually achieves).

[0528] Servo ventilator: A ventilator that measures patient ventilation and has a target ventilation level, and adjusts the pressure support level to bring patient ventilation closer to the target ventilation.

[0529] Spontaneous / Timing (S / T): A mode of a ventilator or other device that attempts to detect the start of breathing in a patient who is breathing spontaneously. However, if the device fails to detect breathing within a predetermined period, the device automatically initiates respiratory delivery.

[0530] Swing: A term equivalent to pressure assistance.

[0531] Triggered: When a ventilator, or other respiratory therapy device such as an RPT device or portable oxygen concentrator, delivers a certain volume of breathable gas to a spontaneously breathing patient, the device is said to be triggered to do so. Triggering occurs when the patient initiates the respiratory portion of the respiratory cycle, or before or after initiating it. 5.11.4 Anatomy 5.11.4.1 Anatomical structure of the face

[0532] Wing (Ala): The "wing" of the outer wall or each nostril (plural: alar)

[0533] Wing angle:

[0534] Wing (Alare): The outermost point on the nasal wing.

[0535] Wing curvature (or nostril apex) point: The furthest point on the curved reference line of each wing, found in the wrinkles formed by the junction of the wing and cheek.

[0536] Auricle: The entire visible part of the ear.

[0537] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0538] (Nasal) cartilage: The cartilage of the nose includes the septal cartilage, lateral cartilage, macrocartilage, and microcartilage.

[0539] Columella: A piece of skin that separates the nostrils, extending from the tip of the nose to the upper lip.

[0540] Columella angle: The angle between a line drawn through the midpoint of the nostrils and a line drawn perpendicular to the Frankfort horizontal, crossing the subnasal point.

[0541] Frankfort horizontal plane: A line extending from the lowest point of the orbital rim to the left auricle. The auricle is the deepest point from the upper side of the notch to the tragus of the auricle.

[0542] Glabella: Located in soft tissue, it is the most prominent point in the midline sagittal plane of the forehead.

[0543] Lateral nasal cartilage: A generally triangular plate of cartilage. Its upper margin is attached to the nasal bone and the frontal process of the maxilla, and its lower margin is connected to the greater alar cartilage.

[0544] Lip, lower side (lower lip: labrale inferius):

[0545] Lip, upper side (upper lip: labrale superius):

[0546] Greater alar cartilage: A cartilaginous plate located beneath the lateral nasal cartilage. It curves around the anterior portion of the nostril. Its posterior end connects to the frontal process of the maxilla by a tough fibrous membrane containing three or four wing cartilages.

[0547] Nostrils: Generally, ellipsoidal pterygoides form the entrance to the nasal cavity. The singular form of nostril (nares) is nostril (naris). These nostrils are separated by the nasal septum.

[0548] Nasolabial fold or groove: A fold or groove of skin that extends from each side of the nose to the corners of the mouth, separating the cheek from the upper lip.

[0549] Nasolabial angle: The angle between the columella and the upper lip, which crosses the subnasal point.

[0550] Inferior fundus point: The lowest point where the auricle attaches to the skin of the face.

[0551] Superior basement point: The highest point where the auricle attaches to the skin of the face.

[0552] Nasal tip: The most prominent point or tip of the nose, which can be seen in a lateral view of the rest of the head.

[0553] Philtrum: The midline groove extending from the lower boundary of the nasal septum to the upper part of the lip in the upper lip region.

[0554] Pogonion: The anterior midpoint of the jaw, located on soft tissue.

[0555] Ridge (nose): The nasal ridge is the midline elevation of the nose, extending from the selion to the nasal tip.

[0556] Sagittal plane: A vertical plane that extends from the front (anterior) to the back (posterior). The median sagittal plane is the sagittal plane that divides the plane into the right and left halves.

[0557] Serion: The most concave point located on soft tissue within the region of the frontonasal suture.

[0558] Septal cartilage (nose): The nasal septum cartilage is part of the septum and divides the anterior part of the nasal cavity.

[0559] The lowest point of the nasal ala: This is a point on the lower periphery of the wing base, where the wing base joins the skin of the upper lip.

[0560] Subnasal point: Located on soft tissue, this is the point where the columella merges with the upper lip in the midline sagittal plane.

[0561] Supramenton: The most concave point on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue pogonion.

[0562] Skull Anatomy

[0563] Frontal bone: The frontal bone includes the frontal squama, a large vertical portion that corresponds to the area known as the forehead.

[0564] Mandible: The mandible forms the lower jaw. The mental protuberance is a bony protuberance in the jaw and forms the jaw.

[0565] Maxilla: The maxilla forms the upper jaw and is located above the mandible, below the orbit. The frontal process of the maxilla protrudes upward from the side of the nose, forming its lateral boundary.

[0566] Nasal bones: The nasal bones are two small rectangular bones that vary in size and shape from person to person. The nasal bones are located side by side in the middle and upper parts of the face, and their joint forms the "bridge" of the nose.

[0567] Nasal root point: The intersection of the frontal bone and the two nasal bones, a concave area directly located between the upper part of the bridge between the eye and the nose.

[0568] Occipital bone: The occipital bone is located in the posterior and inferior part of the skull. The occipital bone contains the foramen magnum, an oval-shaped opening through which the intracranial cavity connects to the vertebral canals. The curved plate on the posterior side of the foramen magnum is the occipital squama.

[0569] Orbit: The cavity in the skull that houses the eyeball.

[0570] Parietal bone: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0571] Temporal bone: The temporal bone is located on the base and sides of the skull and supports the part of the face known as the temple.

[0572] Cheekbones: The two cheekbones in the face are located in the upper and outer parts of the face, forming the cheekbones. 5.11.4.2 Anatomical structure of the respiratory system

[0573] The diaphragm is a sheet of muscle that extends over the lower part of the rib cage. It separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases, drawing air into the lungs.

[0574] Larynx: The larynx or vocal organ that houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0575] Lungs: The respiratory organ in humans. The conductive zone of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0576] Nasal cavity: The nasal cavity (or nasal fossa) is a large, air-filled space located in the center of the face, above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called the nasal conchae or nasal bones. The nose is located anterior to the nasal cavity, and posteriorly it connects to the nasopharynx via the posterior nostrils.

[0577] Pharynx: The part of the throat located directly below the nasal cavity and above the esophagus and larynx. The pharynx is traditionally divided into the following three sections: nasopharynx (upper pharynx) (the nasal part of the pharynx), oropharynx (oropharynx) (the oral part of the pharynx), and pharynx (lower pharynx). 5.11.5 Patient Interface

[0578] Anti-choking valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to the atmosphere in a fail-safe manner.

[0579] Elbow: An elbow is an embodiment of a structure that directs the axis of airflow moving within, changing its direction through an angle. In one embodiment, the angle may be approximately 90 degrees. In another embodiment, the angle may be greater than or less than 90 degrees. An elbow may have a substantially circular cross-section. In another embodiment, an elbow may have an elliptical or rectangular cross-section. In certain embodiments, an elbow may be rotatable, for example, about 360 degrees relative to a mating component. In certain embodiments, an elbow may be detachable from a mating component, for example, via a snap connection. In certain embodiments, an elbow may be assembled to a mating component via a one-time snap during manufacturing, but cannot be detached by the patient.

[0580] Frame: The term "frame" is taken to mean a mask structure that supports the tensile load between two or more points connecting the headgear. The mask frame may be an airtight load-supporting structure within the mask. However, some forms of mask frames may be airtight.

[0581] Headgear: Headgear is taken to mean a form of positioning and stabilization structure designed for use on the head. For example, headgear may include a collection of one or more struts, ties, and stiffeners configured to position and hold a patient interface in place on the patient's face for the delivery of respiratory therapy. Some ties are formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).

[0582] Membrane: The term "membrane" is typically used to mean a thin-walled element, preferably one that offers virtually no resistance to bending and resistance to stretching.

[0583] Plenum Chamber: The term "mask plenum chamber" is taken to mean a part of the patient interface having a wall that at least partially encloses the volume of space, where the air in the volume is pressurized to exceed atmospheric pressure when in use. A shell may form part of the wall of the mask plenum chamber.

[0584] Seal: When used as a noun ("seal"), it can refer to a structure; when used as a verb ("to seal"), it can refer to the effect of sealing. Two elements can be constructed and / or arranged to "seal" or achieve a "sealing" effect between them without requiring a separate "seal" element itself.

[0585] Shell: The term "shell" is taken to mean a curved, relatively thin-walled structure with bending, tensile, and compressive stiffness. For example, the curved structural walls of a mask can be a shell. In some forms, a shell can be faceted. In some forms, a shell can be airtight. In some forms, a shell may not be airtight.

[0586] Stiffener: The term "stiffener" is understood to mean a structural component designed to increase the rigidity of another component in at least one direction.

[0587] Support: The term "support" is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0588] Swivel (noun): A subassembly of components configured to rotate preferably independently and preferably under low torque around a common axis. In one embodiment, the swivel may be configured to rotate at an angle of at least 360 degrees. In another embodiment, the swivel may be configured to rotate at an angle of less than 360 degrees. When used in the context of air delivery conduits, the subassembly of components preferably includes a pair of cylindrical conduits. During use, there is little to no leakage of airflow from the swivel.

[0589] Thai (noun): A structure designed to resist tension.

[0590] Ventilation section (noun): A structure that allows airflow into the surrounding air inside a mask or conduit, enabling clinically effective extrusion of the exhaled gas. For example, clinically effective extrusion may involve flow rates of approximately 10 liters / min to 100 liters / min, depending on the mask design and treatment pressure. 5.11.6 Shape of the structure

[0591] Products based on this technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or an impeller). The three-dimensional structure may be limited by two-dimensional surfaces. These surfaces may be distinguished using labels to describe the orientation, position, function or any other characteristic of the associated surface. For example, the structure may include one or more of a front surface, a back surface, an inner surface, and an outer surface. In another embodiment, the seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or inner) surface. In another embodiment, the structure may include a first surface and a second surface.

[0592] To facilitate the description of the shape and surface of the three-dimensional structure, we first consider the cross-section at point p through the surface of the structure. Please refer to Figures 3B to 3F. Figures 3B to 3F show examples of cross-sections at point p on the surface and examples of the resulting planar curves. Figures 3B to 3F also show the outward normal vector at p. The outward normal vector at p extends in the direction away from the surface. In some embodiments, this surface is described from the perspective of a hypothetical small person standing upright on the surface. 5.11.6.1 Curvature in one dimension

[0593] The curvature of a plane curve at p can be described as having a sign (e.g., positive, negative) and magnitude (e.g., 1 / radius of a circle tangent to the curve at p).

[0594] Positive curvature: When a curve at point p curves toward the outward normal, the curvature at that point is taken to have a positive value (if this hypothetical little person were to leave point p, they would need to walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such a curve is often called concave.

[0595] Zero curvature: If the curve at point p is a straight line, the curvature is taken as zero (if this hypothetical small person leaves point p, they can walk on a horizontal plane that is neither upward nor downward). See Figure 3D.

[0596] Negative curvature: When a curve at point p curves away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if this hypothetical little person were to walk away from point p, they would need to walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F) and Figure 3F (relatively large negative curvature compared to Figure 3E). Such curves are often called convex. 5.11.6.2 Curvature of a two-dimensional surface

[0597] The description of the shape at a given point on a two-dimensional surface using this technique may include multiple perpendicular cross-sections. These cross-sections can cut the surface in a plane containing an outward normal ("normal plane"), and each cross-section may be taken in a different direction. Each cross-section results in a planar curve with a corresponding curvature. The different curvatures at that point may have the same or different signs. Each curvature at that point has a magnitude (e.g., relatively small). The planar curves in Figures 3B to 3F may be examples of such multiple cross-sections at a particular point.

[0598] Major curvature and direction: The direction of the normal plane in which the curvature of a curve takes its maximum and minimum values ​​is called the major direction. In the examples in Figures 3B to 3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F; therefore, Figures 3B and 3F are cross-sections in the major direction. The major curvature at p is the curvature in the major direction.

[0599] A region of a surface: A set of connected points on a surface. These points within a region may share similar properties (e.g., curvature or sign).

[0600] Saddle region: A region where the principal curvatures at each point have opposite signs (i.e., one positive sign and the other negative sign), depending on the direction a hypothetical person walking uphill or downhill is facing.

[0601] Dome region: A region where the main curvatures at each point have the same sign (both are positive ("concave dome") or both are negative ("convex dome")).

[0602] Cylindrical region: A region where one major curvature is zero (or zero within a manufacturing tolerance, for example) and the other major curvature is non-zero.

[0603] Planar region: A region of a surface where both major curvatures are zero (or zero, for example, within a manufacturing tolerance).

[0604] Surface edge: The boundary or limit of a surface or area.

[0605] Path: In certain forms of this technology, “path” is taken to mean a path in a mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of this technology, “path” can be described, for example, as a route or course containing a set of points on a surface. (A hypothetical person’s path is the places they walk on the surface, similar to a path in a garden).

[0606] Path Length: In certain forms of this technology, "path length" refers to the distance from f(0) to f(1) along the surface (i.e., the distance along the path on the surface). There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length of a hypothetical person is the distance they walk along the path on the surface).

[0607] Straight-line distance: Straight-line distance is the distance between two points on a surface, but the surface itself is not considered. On a planar domain, there exists a path on the surface with the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there cannot be a path with the same path length as the straight-line distance between two points. (For a hypothetical person, straight-line distance corresponds to the distance a crow "flies".) 5.11.6.3 Space curve

[0608] Spatial curves: Unlike plane curves, spatial curves do not necessarily exist within any given plane. Spatial curves can be closed; that is, they have no endpoints. Spatial curves can be considered as one-dimensional pieces of three-dimensional space. A hypothetical person walking along a DNA helix would be walking along a spatial curve. A typical human left ear contains a left-handed helix (see Figure 3Q). A typical human right ear contains a right-handed helix (see Figure 3R). Figure 3S shows a right-handed helix. The edges of structures (e.g., the edges of a membrane or impeller) can follow spatial curves. In general, spatial curves can be described by their curvature and torsion at each point on the curve. Torsion is a measure of the nature of a curve originating from a plane. Torsion has a sign and magnitude. Torsion at a point on a spatial curve can be characterized with respect to the tangent, normal, and binormal vectors at that point.

[0609] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional character is flying along a curve and falls from their vehicle at a certain point, the direction of the tangent vector would be the direction in which the character would have been moving.

[0610] Unit Normal Vector: When a fictional character is moving along a curve, the tangent vector itself changes. The unit vector that points in the same direction as the changing tangent vector is called the unit principal normal vector. This is perpendicular to the tangent vector.

[0611] Binormal Unit Vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P) or the left-hand rule (Figure 3O).

[0612] Contact plane: The plane containing the unit tangent vector and the unit principal normal vector. See Figures 3O and 3P.

[0613] Torsion of a spatial curve: Torsion of a spatial curve at a point is the magnitude of the rate of change of the binormal unit vector at that point. This measures the degree of deviation of the curve from the tangent plane. Torsion of a spatial curve in a plane is zero. If the deviation of a spatial curve from the tangent plane is relatively small, the magnitude of the torsion of that spatial curve is relatively small (e.g., a gently sloping helical path). If the deviation of a spatial curve from the tangent plane is relatively large, the magnitude of the torsion of that spatial curve is relatively large (e.g., a steeply sloping helical path). Referring to Figure 3S, since T2 > T1, the magnitude of the torsion in the neighborhood of the uppermost coil of the helix in Figure 3S is greater than the magnitude of the torsion of the lowermost coil of the helix in Figure 3S.

[0614] Referring to the right-hand rule in Figure 3P, a spatial curve curving toward the direction of the right-hand binormal can be considered to have a positive twist in the right-hand direction (e.g., a right-hand spiral as shown in Figure 3S). A spatial curve pointing away from the direction of the right-hand binormal can be considered to have a negative right-hand twist (e.g., a left-hand spiral).

[0615] Similarly, referring to the left-hand rule (see Figure 3O), a spatial curve pointing in the direction of the left-hand binormal can be considered to have a positive left-hand twist (e.g., a left-hand spiral). Thus, the positive direction of the left hand corresponds to the negative direction of the right hand. See Figure 3T. 5.11.6.4 Hole

[0616] A surface may have one-dimensional holes (e.g., holes bounded by planar or spatial curves). In the case of a thin-walled structure containing holes (e.g., a film), this structure can be described as having one-dimensional holes. See, for example, the one-dimensional holes in the surface of the structure shown in Figure 3I, bounded by planar curves.

[0617] The structure may have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the inner surface of the tire. In another embodiment, a bladder with a cavity for air or gel may have a two-dimensional hole. See, for example, the cushion in Figure 3L, and the exemplary cross-sections in Figures 3M and 3N, where the inner surface bounding the two-dimensional hole is shown. In yet another embodiment, a conduit may include a one-dimensional hole (e.g., at its inlet or outlet) and a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole through the structure shown in Figure 3K and bounded by a surface as shown. 5.12 Other Notes

[0618] Some of the disclosures in this patent document include content that is protected by copyright. The copyright holder retains all copyrights to any other purpose, except that any reproduction of this patent document or this patent disclosure by fax by any person is permitted if it is included in the patent files or records of the Japan Patent Office.

[0619] Unless otherwise clearly indicated by the context or provided for a range of values, it is understood that 1 / 10 of the lower limit, the interval between the upper and lower limits of the range, and each intervention value for any other stated values ​​or intervention values ​​within the stated range are included in this technique. Even if the upper and lower limits of these intervention ranges, independently included within the intervention range, specifically exceed the limits within the stated range, they are also included in this technique. If the stated range includes one or both of these limits, the range exceeding either or both of these stated limits is also included in this technique.

[0620] Furthermore, where values ​​are embodied in this specification as part of the Art, unless otherwise specified, it is understood that such values ​​may be approximated and used to any appropriate number of significant figures as permitted or required by the practical technical implementation.

[0621] Furthermore, “approximately,” “substantially,” “about,” or any similar terms used herein mean + / - 5 to 10% of the stated values.

[0622] Unless otherwise specified, all technical and scientific terms in this specification have the same meaning as those commonly understood by those skilled in the art. Any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this art, but only a limited number of exemplary methods and materials are described herein.

[0623] While certain materials are described as suitably used in constructing components, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are understood to be manufacturable and therefore can be manufactured collectively or individually.

[0624] Note that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0625] All published documents cited herein are used for disclosure and description of the methods and / or materials covered by those documents, and are incorporated for reference only. The published documents cited herein are provided solely for the purposes of their disclosure prior to the filing date of this application. Nothing in this specification should be construed as indicating that the present technology is not prior to such published documents for the purpose of prior patents. Furthermore, the dates of the published documents cited herein may differ from the actual dates of the published documents and may require individual verification.

[0626] The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that the elements, components, or steps described may exist, be used, or be combined with other elements, components, or steps not explicitly stated.

[0627] The headings used in the detailed descriptions are for the convenience of the reader and should not be used to limit the content found in this disclosure or the claims as a whole. These headings should not be used in the interpretation of the scope of the claims or the limitations of the claims.

[0628] While the techniques described herein have been referred to with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may indicate specific details that are not necessary for carrying out the techniques. For example, terms such as “first” and “second” (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any arbitrary order and are used to distinguish separate elements. Furthermore, while the descriptions or examples of process steps in the methods may be given in order, such order is not required. Those skilled in the art will recognize that such order is changeable and / or that such embodiments can be performed simultaneously or even synchronously.

[0629] Therefore, it should be understood that numerous modifications are possible in the exemplary embodiments, and other arrangements may be devised, without departing from the intent and scope of this technology. [Explanation of Symbols]

[0630] 5.13 List of reference codes 8000 Patient Interfaces 8010 Headgear 8020 Stabilizing Structure 8030 Air outlet 8040 Air Inlet 8050 Conduit 8060 Headgear Tubing 8070 Inner layer 8080 film 8090 film 8100 Seal-forming structure 8110 Airflow 8120 Seam Tape 9000 Patient Interface 9010 Headgear 9020 Tension structure 9030 Exit 9040 Air Inlet 9050 Fastening part 9060 Headgear Tubing 9070 Inner 9080 Ventilation section 9090 Seal-forming structure 9100 Sealing flange 9110 Plenum Chamber 9112 Entrance Port 9120 First air-retaining material 9120a Outer surface of the first air-retaining material 9125 End-to-end connection 9130 Second air-retaining material 9130a Outer surface of the second air-retaining material 9140 Conduit / Cavity 9150 First fabric layer 9160 Second fabric layer 9170 Foam 9180 Vertical 9190 First horizontal axis 9200 Second horizontal axis 10000 patient interfaces 10010 Headgear 10030 Tensile structure 10040 Retention structure 10050 Exit 10060 Fastening part 10070 Inner surface of double-walled film 11000 Patient Interface 11010 Headgear 11020 Tensile structure 11030 Exit 11040 Entrance 11050 First fabric layer 11060 Second fabric layer 11050a First Fabric Layer 11050b First Fabric Layer 4170 Pneumatic Tubing 11100 Seal-forming structure 12000 Patient Interface 12010 Headgear 12020 Tensile structure 12030 Orifice 12040 Retention structure 12050 First fabric layer 12060 Second fabric layer 4170 Tubing 12100 Seal-forming structure 13000 Composite materials 13010 First fabric layer 13020 First air-retaining material 13030 Second air-retaining material 13040 Second fabric layer 13050 Foam 13060 Cavity 13070 First Aspect 13080 Second Aspect 13090 Third Fabric Layer 14000 Headgear 14010 Headgear Tubing 14020 Kink 14000a Headgear 15000 Headgear Tubing 15020 First Aspect 15030 Second Aspect 15040 Second fabric layer 15100 First fabric layer 15220 Rigidizer 15230 Spine 15240 Protrusion 15250 Color 16000 Headgear Tubing 16020 First Aspect 16030 Second side 16040 Second fabric layer 16100 First fabric layer 16220 Rigidizer 16230 Spine 16240 Protrusion 16250 Color 16260 tabs 16270 Spine width 16280 Rigidizer width 17220 Rigidizer 17230 Spine 17250 Color 17260 tabs 18000 Headgear Tubing 18030 Second Aspect 18220 Rigidizer 18230 Spine 18240 Protrusion 18250 Color 18260 tabs 19220 Rigidizer 19240 Protrusion 20000 residizer 20240a Opposing protrusions 20240b Alternating protrusions 20240c Alternating protrusions 20230 Spine 20230a Spine 21010 Rigidizer 21020 Second air-retaining material 21030 First fabric layer 21040 Second fabric layer 21050 Foam 21060 Foam 23000 Plenum Chamber 23010 Frame 23020 Brada 23030 Seal-forming structure 23040 Valve Socket 23050 Elbow Ring 23060 Rib

Claims

1. Throughout the patient's entire respiratory cycle, the patient's air pressure is at least 6 cmH higher than ambient pressure. ２ A headgear for providing a force to hold a seal-forming structure, constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, in a therapeutically effective position on the patient's head for the delivery of airflow at high therapeutic pressure, At least one air inlet, The headgear includes at least one air outlet that can be positioned in fluid communication with the seal-forming structure when in use, A headgear tubing extending between the air inlet and the air outlet, At least one rigidizer positioned within the headgear tubing, Includes a tension structure for providing a force to maintain the seal-forming structure during use, The headgear tubing is expandable in one direction from a compressed state to an expanded state in order to form a passage for supplying pressurized air to the patient. A headgear in which the headgear tubing is foldable on its own when the headgear tubing is in a compressed state.

2. The headgear according to claim 1, wherein the headgear tubing includes fastening portions that fluidly connect at least two material pieces that form at least partially the headgear tubing.

3. The headgear according to claim 2, wherein the fastening portion is movable between a first position in which the interior of the passage is exposed to the surroundings and a second position in which the passage is configured to carry the airflow between the at least one air inlet and the at least one air outlet.

4. The headgear according to claim 3, wherein the fastening portion is a zipper, tape, or hook-and-loop fastener.

5. The headgear according to any one of claims 3 to 4, wherein the fastening portion is formed as part of a double-walled film and is configured to expose the inner surface of the double-walled film at the first position.

6. The headgear according to any one of claims 3 to 5, wherein the fastening portion extends at least partially between the at least one air inlet and the at least one air outlet.

7. The headgear according to any one of claims 3 to 6, wherein the fastening portion is located in the first position adjacent to the at least one air outlet and in the second position adjacent to the at least one air inlet.

8. The headgear according to any one of claims 3 to 7, wherein the fastening portion is located on the non-patient contact side of the headgear tubing.

9. Throughout the patient's entire respiratory cycle, the patient's air pressure is at least 6 cmH higher than ambient pressure. ２ A headgear for providing a force to hold a seal-forming structure, constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, in a therapeutically effective position on the patient's head for the delivery of airflow at high therapeutic pressure, At least one air inlet, When the headgear is in use, at least one air outlet is in fluid communication with the seal-forming structure, A headgear tubing extending along the length between the air inlet and the air outlet, formed from a composite material, Includes a tension structure for providing a force to maintain the seal-forming structure at the point of use, The aforementioned composite material is A double-wall film defines the internal cavity between each wall, Including an outer surface having a first side and a second side, The aforementioned double-walled film does not allow pressurized air to pass through, A first fabric layer is connected to the first side surface, and a second fabric layer is connected to the second side surface. The headgear tubing has a first transverse axis that extends generally laterally along the length of the headgear tubing, and a second transverse axis that extends generally laterally with respect to the first transverse axis. The headgear tubing is more expandable in the first direction along the first horizontal axis than in the second direction along the second horizontal axis.

10. The bending modulus of the composite material is 15 N / mm². ２ The headgear according to claim 9, which is less than [amount missing].

11. The headgear according to claim 9 or 10, wherein the headgear tubing is made of a stretchable material.

12. The headgear according to any one of claims 9 to 11, wherein the headgear tubing is more elastic along at least a portion of its length than the second horizontal axis.

13. The Young's modulus of the headgear tubing along the aforementioned length is approximately 15 N / mm². ２ ~Approx. 150N / mm ２ The headgear according to any one of claims 9 to 12.

14. The headgear according to any one of claims 9 to 13, wherein the first fabric layer further includes a fastening portion that can be opened to expose the double-walled film.

15. The headgear according to claim 14, wherein the fastening portion contacts the headgear tubing along the length.

16. The headgear according to claim 14 or 15, wherein the fastening portion extends from a first position adjacent to the at least one air inlet to a second position adjacent to the at least one air outlet.

17. The headgear according to any one of claims 9 to 16, wherein the headgear tubing is flat when compressed.

18. The headgear according to any one of claims 9 to 17, wherein the headgear tubing further includes a vent near the at least one air outlet of the headgear.

19. The headgear according to any one of claims 9 to 18, wherein when inflated, the headgear tubing is positioned to conform to the contour of the patient's head.

20. The bending modulus of the headgear tubing is 15 N / mm². ２ The headgear according to any one of claims 9 to 19, wherein the headgear is less than [amount missing].

21. The headgear according to any one of claims 9 to 20, wherein the second fabric layer is annealed to the first fabric layer.

22. The headgear according to any one of claims 9 to 21, wherein the total transmittance of the double-walled film exceeds 90%.

23. The headgear according to any one of claims 9 to 22, wherein the double-walled film is selected from thermoplastic polyurethane.

24. The headgear according to any one of claims 9 to 23, wherein the first fabric layer is laminated to the first side surface via heat bonding or adhesive bonding.

25. The headgear according to any one of claims 9 to 24, wherein the second fabric layer is laminated to the second side via heat bonding or adhesive bonding.

26. The headgear according to any one of claims 9 to 25, wherein the first fabric layer is a mesh fabric layer, and the mesh fabric layer has a knit structure selected from single jersey, rib, interlock, raschel, or jacquard.

27. The headgear according to any one of claims 9 to 26, wherein the second fabric layer is selected from microfiber yarn, nylon 6,6, peach skin finish, elastic knit fabric, bidirectional stretch fabric, non-stretch fabric, circular knit fabric, woven fabric, or warp knit fabric.

28. The headgear according to any one of claims 9 to 27, wherein the second fabric layer is surface-treated with a hydrophobic coating.

29. The headgear according to any one of claims 9 to 28, wherein the composite material further comprises a foam sandwiched between the second fabric layer and the second side of the double-wall film.

30. The headgear according to any one of claims 9 to 29, wherein the composite material further comprises a foam sandwiched between the first fabric layer and the first side surface of the double-wall film.

31. The headgear according to any one of claims 9 to 30, wherein the headgear tubing is formed from at least two composite materials to provide different rigidities and / or flexibility.

32. The headgear according to any one of claims 1 to 31, wherein the tension structure is positionable to overlap the posterior region of the patient's head.

33. The headgear according to any one of claims 1 to 32, wherein the tension structure is made of an elastic material.

34. The tension structure is formed from the composite material described in claim 9, the headgear according to any one of claims 1 to 26.

35. The headgear according to any one of claims 1 to 34, wherein the air inlet can be positioned to overlap the cranial region of the patient's head when in use.

36. It is a patient interface, A headgear according to any one of claims 1 to 35, The headgear and the at least one air outlet are integrated with or attachable to it, and are at least 6 cmH higher than ambient air pressure. ２ A patient interface comprising a seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway in order to deliver airflow at high pressure.

37. It is a patient interface, At least 6 cmH higher than the ambient pressure. ２ A plenum chamber, including a plenum chamber inlet port that can be pressurized to high therapeutic pressures and is sized and constructed to receive the airflow at said therapeutic pressures for the patient's breathing, During the entire breathing cycle of the patient in use, at least 6 cmH ２ For delivering an air flow at a therapeutic pressure higher than ambient pressure, it is constructed and arranged to form a seal with the area of the patient's face surrounding the inlet to the patient's airway, has holes therein so that the air flow at the therapeutic pressure is delivered to at least an inlet to the patient's nostrils, and is constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the breathing cycle of the patient in use, the patient interface being configured to allow the patient to breathe ambient air through the mouth when there is no flow of pressurized air through the plenum chamber inlet port, or the patient interface being configured to leave the patient's mouth uncovered, a seal-forming structure A headgear for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, At least one air inlet, At least one air outlet that can be positioned in fluid communication with the seal-forming structure when the headgear is in use, A headgear tubing made of a composite material extends along the length between the air inlet and the air outlet, and Includes a tension structure for providing a force to maintain the seal-forming structure at the point of use, The aforementioned composite material is A double-wall film defines the internal cavity between each wall, Including an outer surface having a first side and a second side, The aforementioned double-walled film does not allow pressurized air to pass through, A first fabric layer is connected to the first side surface, and a second fabric layer is connected to the second side surface. The headgear tubing has a first transverse axis that extends generally laterally along the length of the headgear tubing, and a second transverse axis that extends generally laterally with respect to the first transverse axis. The headgear tubing is more expandable in the first direction along the first transverse axis than in the second direction along the second transverse axis. The plenum chamber is adjacent to and in fluid communication with the at least one air outlet of the headgear. The seal-forming structure is a patient interface adjacent to the inner surface of the at least one air outlet of the headgear.

38. The patient interface according to claim 37, further comprising a ventilation structure sized and shaped to allow gas exhaled by the patient to flow continuously from the inside of the plenum chamber outwards and to maintain the therapeutic pressure within the plenum chamber during use.

39. Throughout the patient's entire respiratory cycle, the patient's air pressure is at least 6 cmH higher than ambient pressure. ２ A headgear for providing a force to hold a seal-forming structure, constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, in a therapeutically effective position on the patient's head for the delivery of airflow at high therapeutic pressure, At least one air inlet, The headgear has at least one air outlet that is in fluid communication with the seal-forming structure when in use, A headgear tubing extending along the length between the air inlet and the air outlet, formed from a composite material, At least one rigidizer positioned within the headgear tubing, Includes a tension structure for providing a force to maintain the seal-forming structure at the point of use, The aforementioned composite material is A double-wall film defines the internal cavity between each wall, Including an outer surface having a first side and a second side, The aforementioned double-walled film does not allow pressurized air to pass through, A first fabric layer is connected to the first side surface, and a second fabric layer is connected to the second side surface via the rigidizer. The headgear tubing has a first transverse axis that extends generally laterally along the length of the headgear tubing, and a second transverse axis that extends generally laterally with respect to the first transverse axis. The headgear tubing is more expandable in the first direction along the first horizontal axis than in the second direction along the second horizontal axis.

40. The headgear according to claim 39, wherein the rigidizer is bonded to the second side of the outer surface of the double-walled film.

41. The headgear according to claim 39 or 40, wherein the width of the rigidizer is about 1 / 3 to about 1 / 2 of the width of the headgear tubing along the second horizontal axis.

42. The headgear according to any one of claims 39 to 41, wherein the thickness of the rigidizer is approximately 200 μm to approximately 2 mm.

43. The headgear according to claim 39 or 42, wherein the rigidizer includes a spine that extends at least partially along the headgear tubing.

44. The headgear according to claim 43, wherein the spine has a tapered profile.

45. The headgear according to claim 43 or 44, wherein the spine has an elongated structure, a zigzag structure, a square wave structure, or a sinusoidal wave structure.

46. The headgear according to any one of claims 43 to 45, wherein the rigidizer includes a plurality of projections extending from at least one side of the spine.

47. The headgear according to claim 46, wherein the plurality of protrusions are spaced apart from each other at intervals along the length of the spine.

48. The headgear according to claim 46 or 47, wherein the protrusions are formed on both sides of the spine.

49. The headgear according to any one of claims 46 to 48, wherein a projection on one side of the spine has a projection facing the other side.

50. The headgear according to any one of claims 46 to 49, wherein a projection on one side of the spine is spaced laterally apart from an opposing projection.

51. The headgear according to any one of claims 46 to 50, wherein the contact angle of each of the protrusions is approximately 20° to approximately 60° with respect to the spine.

52. The headgear according to any one of claims 46 to 51, wherein the spine and the protrusion each comprise different materials.

53. The headgear according to any one of claims 46 to 52, wherein the spine and the protrusion each have different elasticity and / or flexibility.

54. The headgear according to any one of claims 46 to 53, wherein the thickness of the spine and the protrusion are different.

55. The headgear according to any one of claims 46 to 54, wherein the spine and the projection are formed from different materials.

56. The headgear according to any one of claims 46 to 55, wherein the spine comprises an elastomer.

57. The headgear according to claim 39, wherein the rigidizer comprises a collar structure for supporting the region of the headgear tubing adjacent to the air inlet.

58. The headgear according to claim 39 or 57, wherein the collar structure is a C-ring structure.

59. The headgear according to claim 39, wherein the rigidizer includes at least one tab for connecting to a tension structure.

60. The headgear according to claim 39 or 59, wherein the tab is connected to the spine.

61. The headgear according to any one of claims 39 to 60, further comprising a foam positioned between the rigidizer and the second fabric layer.

62. The headgear according to any one of claims 39 to 61, further comprising a foam that sandwiches the rigidizer.

63. It is a patient interface, A headgear according to any one of claims 1 to 8 or 39 to 62, The headgear is integrated with or attachable to the aforementioned air outlet, and is at least 6 cmH higher than ambient air pressure. ２ A patient interface comprising a seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway in order to deliver airflow at high pressure.

64. It is a patient interface, At least 6 cmH higher than the ambient pressure. ２ A plenum chamber, including a plenum chamber inlet port that can be pressurized to high therapeutic pressures and is sized and constructed to receive the airflow at said therapeutic pressures for the patient's breathing, Throughout the patient's entire respiratory cycle, the patient's air pressure is at least 6 cmH higher than ambient pressure. ２ A seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway for the delivery of airflow at high therapeutic pressure, having a hole therein so that the airflow at therapeutic pressure is delivered to at least the entrance to the patient's nostrils, and constructed and positioned to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle in use, wherein the patient interface is configured to allow the patient to breathe through their mouth from the surroundings when there is no pressurized airflow through the plenum chamber entrance port, or the patient interface is configured to leave the patient's mouth uncovered. A headgear constructed and positioned to provide a force that holds the seal-forming structure in a therapeutically effective position on the patient's head, At least one air inlet, At least one air outlet that can be positioned in fluid communication with the seal-forming structure when the headgear is in use, Headgear tubing extending along the length between the air inlet and the air outlet, formed from a composite material, At least one rigidizer positioned adjacent to the headgear tubing, and A headgear including a tension structure for providing a force to maintain the seal-forming structure in the position of use, The aforementioned composite material is A double-wall film defines the internal cavity between each wall, Including an outer surface having a first side and a second side, The aforementioned double-walled film does not allow pressurized air to pass through, A first fabric layer is connected to the first side surface, and a second fabric layer is connected to the second side surface via the rigidizer. The headgear tubing has a first transverse axis that extends generally laterally along the length of the headgear tubing, and a second transverse axis that extends generally laterally with respect to the first transverse axis. The headgear tubing is more expandable in the first direction along the first transverse axis than in the second direction along the second axis. The plenum chamber is adjacent to and in fluid communication with the at least one air outlet of the headgear. The seal-forming structure is a patient interface adjacent to the inner surface of the at least one air outlet of the headgear.

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