Patient interface and positioning and stabilizing structure for a patient interface

Abstract

A positioning and stabilizing structure for a patient interface comprises: a headband formed at least in part from a fabric material and having an upper fabric portion movably connected to a first lower fabric portion, the headband including one or more sensors provided in or on the upper fabric portion and / or the first lower fabric portion; wherein the headband is wearable on the patient's head in a first configuration and a second configuration, wherein in the first configuration, the first lower fabric portion is adjacent to the upper fabric portion, and in the second configuration, the first lower fabric portion is separated from the upper fabric portion and provides a force to maintain the sealing-forming structure of the patient interface in a therapeutically effective position on the patient's head.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims the benefit of U.S. Patent Application No. 10202006315Y, filed on June 30, 2020, which is incorporated herein by reference in its entirety. Background Art 2.1 Technical Field

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

[0005] 2.2 Description of Related Technologies

[0006] 2.2.1 Human respiratory system and its disorders

[0007] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrances to a person's airways.

[0008] The airway comprises a series of branch tubes, and when the branch trachea penetrates deeper into the lungs, it becomes narrower, shorter and more numerous. The main function of the lungs is gas exchange, thereby allowing oxygen to enter the venous blood from the inhaled air and to expel carbon dioxide in the opposite direction. The trachea is divided into the left main bronchus and the right main bronchus, which are eventually divided into terminal bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Further branches of the airway lead to the respiratory bronchioles and eventually lead to the alveoli. The alveolar region of the lungs is the area where gas exchange occurs and is called the respiratory zone. Referring to " Respiratory Physiology (Respiratory Physiology)" published by John B.West, Lippincott Williams & Wilkins in 2012, the 9th edition.

[0009] There are a range of respiratory disorders. Some disorders can be characterized by specific events such as apnea, hypopnea, and hyperpnea.

[0010] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0011] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events including occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway and normal loss of muscle tone in the area of ​​the tongue, soft palate, and posterior oropharyngeal wall during sleep. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. Complications are common disorders, especially in middle-aged overweight men, but those affected may not be aware of this problem. Referring to U.S. Patent No. 4,944,310 (Sullivan).

[0012] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller in which there are rhythmic alternating cycles of boom-and-bust ventilation called CSR cycles. CSR is characterized by repeated hypoxia and reoxygenation of arterial blood. Due to the repeated lack of oxygen, CSR can be harmful. In some patients, CSR is associated with repeated arousals from sleep, which leads to severe sleep disruption, increased sympathetic nerve activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] Respiratory failure is an umbrella term for breathing disorders in which the lungs cannot take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following disorders.

[0014] People with respiratory insufficiency (a form of respiratory failure) may become abnormally short of breath during exercise.

[0015] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia during wakefulness, in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0016] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These conditions include increased resistance to air flow, a prolonged expiratory phase of breathing, and a loss of the lungs' normal elasticity. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: difficulty breathing on exertion, a chronic cough, and sputum production.

[0017] Neuromuscular disease (NMD) is a broad term that encompasses many diseases and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of the ability to walk, confinement to a wheelchair, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive types: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within a few years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over many years and only slightly reduces life expectancy (e.g., limb girdle, scapulohumeral and myotonic dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, dysphagia, dyspnea during exercise and at rest, fatigue, drowsiness, morning headaches, and difficulty concentrating and mood changes.

[0018] Chest wall disorders are a group of thoracic disorders that result in inefficient connections between the respiratory muscles and the thorax. These disorders are often characterized by restrictive defects and have the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0019] A range of treatments have been used to treat or alleviate these conditions. In addition, such treatments can be used to prevent breathing problems in otherwise healthy individuals. However, these treatments have a number of drawbacks.

[0020] 2.2.2 Treatment

[0021] Various respiratory therapies, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), and high flow therapy (HFT) have been used to treat one or more of the above-mentioned respiratory disorders.

[0022] 2.2.2.1 Respiratory pressure therapy

[0023] Respiratory pressure therapy is the supply of air to the airway entrance at a controlled target pressure that is nominally positive relative to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as cannulated or tube-based ventilators).

[0024] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treating OSA with CPAP therapy can be voluntary, so if the patient finds that the device used to provide such treatment is any one or more of: uncomfortable, difficult to use, expensive, and unsightly, the patient may choose not to comply with the treatment. Uncomfortable, difficult to use, expensive, and aesthetically unappealing.

[0025] Non-invasive ventilation (NIV) provides ventilation support to the patient through the upper airway to help the patient breathe and / or maintain appropriate oxygen levels in the body by completing some or all of the work of breathing. Ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, which is in the form of OHS, COPD, NMD and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0026] Non-invasive ventilation (IV) provides ventilation support to patients who are unable to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0027] 2.2.2.2 Flow treatment

[0028] Not all respiratory therapies are intended to provide prescribed treatment pressures. Some respiratory therapies are intended to deliver a prescribed respiratory volume by delivering an inspiratory flow curve (possibly superimposed on a positive baseline pressure) within a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy can only supplement the patient's own spontaneous breathing with a flow of regulated or enriched gas. In one example, high flow therapy (HFT) provides a continuous, heated, humidified air flow to the airway entrance through an unsealed or open patient interface at a "treatment flow" that remains roughly constant throughout the respiratory cycle. The treatment flow is nominally set to exceed the patient's peak inspiratory flow. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. A mechanism of action is that the high flow of air at the airway entrance improves ventilation efficiency by flushing or washing out exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as deadspace therapy (DST surgery). Other benefits may include increased warmth and humidity (possibly beneficial in secretion management) and the possibility of appropriately increasing airway pressure. As an alternative to a constant flow, the therapeutic flow may follow a curve that varies during the respiratory cycle.

[0029] Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. A physician can prescribe continuous oxygen-enriched flow of air at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.) and a specified oxygen concentration (the oxygen fraction of ambient air, ranging from 21% to 100%), delivered to the patient's airway.

[0030] 2.2.2.3 Supplemental oxygen

[0031] For some patients, oxygen therapy can be combined with respiratory pressure therapy, or HFT, by adding supplemental oxygen to the pressurized air flow. When oxygen is added to respiratory pressure therapy, it is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting treatment is called HFT with supplemental oxygen.

[0032] 2.2.3 Respiratory therapy system

[0033] These respiratory therapies can be provided by a respiratory therapy system or device.Such systems and devices can also be used to screen for, diagnose, or monitor a condition without treating it.

[0034] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0035] 2.2.3.1 Patient interface

[0036] The patient interface can be used to couple the respiratory apparatus to its wearer, for example by providing an air flow to the entrance of the airway. The air flow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal (e.g., a seal) with an area of ​​the patient's face to facilitate delivery of gas at a pressure that varies substantially from the ambient pressure at a positive pressure of about 10 cmH2O relative to the ambient pressure, thereby achieving treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of a gas supply at a positive pressure of about 10 cmH2O to the airway. For flow treatments such as nasal HFT, the patient interface is configured to insufflate the nostrils, but particularly to avoid complete sealing. An example of such a patient interface is a nasal cannula.

[0037] Certain other mask systems may not be functionally suitable for this application. For example, a purely decorative mask may not be able to maintain the appropriate pressure. A mask system for underwater swimming or diving may be configured to prevent the ingress of water from a higher external pressure, but not to maintain the internal air at a higher pressure than the ambient pressure.

[0038] Certain masks may be clinically unsuitable for this technology, for example if they block airflow through the nose and only allow it through the mouth.

[0039] Certain masks may be uncomfortable or impossible with the present technology if they require the patient to insert a portion of the mask structure into their mouth to form and maintain a seal through their lips.

[0040] Certain masks may not be feasible for use while sleeping, such as when sleeping on your side in bed with your head on a pillow.

[0041] Designing a patient interface presents many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly between individuals. Because the head is composed of bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. And the entire head can move during a respiratory therapy session.

[0042] Due to these challenges, some masks face one or more of the following problems: obtrusive, unsightly, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for a long time or when the patient is not familiar with the system. A mask of the wrong size may lead to reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for applying anesthetics are acceptable for their original applications, but for long periods of time (e.g., several hours), such masks are not as comfortable as ideal. This discomfort may lead to reduced patient compliance with treatment. This is even more true if the mask is worn during sleep.

[0043] CPAP therapy is very effective in treating certain breathing disorders, assuming patient compliance. If the mask is uncomfortable or difficult to use, patients may not comply with treatment. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean their mask, which may affect patient compliance.

[0044] While a mask used for other applications (eg, pilots) may not be suitable for treating sleep-disordered breathing, a mask designed for treating sleep-disordered breathing may be suitable for other applications.

[0045] For these reasons, patient interfaces for delivering CPAP during sleep have emerged as a distinct field.

[0046] 2.2.3.1.1 Sealing structure

[0047] The patient interface may include a seal-forming structure. Since it is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

[0048] The patient interface is characterized in part according to the design intent of the seal-forming structure to engage with the face when in use. In one form of the patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left nostril and a second sub-portion that forms a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils when in use. Such a single element may be designed to cover, for example, the upper lip area and the bridge of the nose area of ​​the face. In one form of the patient interface, the seal-forming structure may include an element that surrounds the mouth area when in use, for example, by forming a seal on the lower lip area of ​​the face. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth area when in use. These different types of patient interfaces may be referred to by various names by their manufacturers, including nasal masks, full face masks, nasal pillows, nasal sprays, and oronasal masks.

[0049] A seal-forming structure that is effective in one area of ​​a patient's face may not be suitable in another area, for example, because of the different shapes, structures, variations, and sensitive areas of the patient's face. For example, a seal on swimming goggles that covers the patient's forehead may not be suitable for use on the patient's nose.

[0050] Certain seal-forming structures can be designed for mass manufacturing so that one design can be appropriate, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-manufactured patient interface, one or both must adapt to form a seal.

[0051] One type of seal-forming structure extends around the periphery of the patient interface and is used to seal against the patient's face when a force is applied to the patient interface while the seal-forming structure is in facing engagement with the patient's face. The seal-forming structure may include an air or fluid-filled cushion, or a molded or formed surface of a resilient sealing element made of an elastomer, such as rubber. With this type of seal-forming structure, if the fit is inadequate, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0052] Another type of seal-forming structure incorporates a thin sheet of material around the perimeter of the mask to provide a self-sealing effect against the patient's face when positive pressure is applied within the mask. Similar to the previous types of seal-forming structures, if the fit between the face and the mask is poor, excessive force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or deform during use, causing leaks.

[0053] Another type of seal-forming structure may include friction-fit elements, such as for insertion into a nostril, however some patients find these uncomfortable.

[0054] Another form of seal-forming structure may use an adhesive to achieve the seal. Some patients may find it inconvenient to constantly apply and remove adhesive to their face.

[0055] A range of patient interface seal-forming structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; and WO 2010 / 135,785.

[0056] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan-Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0057] ResMed Ltd. manufactures the following products that incorporate nasal pillows: SWIFT TM Nasal pillow mask, SWIFT TM II nasal pillow mask, SWIFT TM LT nasal pillow mask, SWIFT TM FX Nasal Pillows Mask and MIRAGELIBERTY TM Full face mask. The following patent application assigned to ResMed Ltd. describes an example of a nasal pillow mask: International Patent Application WO 2004 / 073,778 (which describes the ResMed Ltd. SWIFT TM Other aspects of nasal pillows); U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc. SWIFT TM LT nasal pillows); International Patent Applications WO 2005 / 063328 and WO 2006 / 130,903 (which describe other aspects of the ResMed MIRAGE LIBERTY™ full face mask); International Patent Application WO 2009 / 052,560 (which describes other aspects of the ResMed SWIFTTM Other aspects of the FX Nasal Pillows).

[0058] 2.2.3.1.2 Positioning and stabilization

[0059] The seal-forming structure of the patient interface for positive air pressure therapy is subjected to the corresponding force of the air pressure that will destroy the seal. Therefore, various techniques have been used to position the seal-forming structure and maintain it in a sealing relationship with the appropriate part of the face.

[0060] One technique is to use adhesives. See, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0061] Another technique is to use one or more straps and / or stabilizing harnesses.Many of these harnesses suffer from one or more problems such as being ill-fitting, bulky, uncomfortable, and inconvenient to use.

[0062] Another difficulty with known positioning and stabilizing arrangements for respiratory therapy is that they can be complex for patients to attach and correctly position on their heads for effective therapy. Additionally, for those new to respiratory therapy, wearing an unfamiliar device that may cover a significant portion of the head can be an unfamiliar and confronting experience, which can hinder patient compliance.

[0063] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

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

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

[0066] An example of a special requirement for some RPT devices is noise.

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

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

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

[0070] ResMed Elisée TM 150 ventilator and ResMed VS III TM Respirators can provide support for invasive and non-invasive dependent ventilation for adult or pediatric patients for the treatment of a variety of conditions. These ventilators provide capacity ventilation mode and pressure ventilation mode with a single-limb circuit or a double-limb circuit. RPT devices typically include a pressure generator, such as a motor-driven blower or a compressed gas reservoir, and are configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface such as those described above via an air circuit.

[0071] Numerous options are available to the device designer. Design criteria often conflict, meaning that some design choices are far from conventional or unavoidable. Furthermore, certain aspects of comfort and efficacy may be highly sensitive to small and subtle changes in one or more parameters.

[0072] 2.2.3.3 Air circuit

[0073] An air circuit is a conduit or tube that is constructed and arranged to allow air flow, in use, between two components of a respiratory therapy system, such as an RPT device and a patient interface. In some cases, there may be separate branches of the air circuit for inspiration and expiration. In other cases, a single branch of the air circuit is used for inspiration and expiration.

[0074] 2.2.3.4 Humidifier

[0075] Delivering an air stream without humidification can lead to airway drying. Using a humidifier with an RPT device and a patient interface produces humidified gas, minimizing drying of the nasal mucosa and increasing patient airway comfort. Additionally, in colder climates, warm air, typically applied to the facial area in and around the patient interface, is more comfortable than cold air.

[0076] Many artificial humidification devices and systems are known, however they do not meet the special requirements of medical humidifiers.

[0077] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to ambient air when needed, typically where the patient may be asleep or resting (e.g., in a hospital). Medical humidifiers for bedside placement can be very small. A medical humidifier can be configured to only humidify and / or heat the air stream delivered to the patient, without humidifying and / or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, evaporative coolers, etc.) can also humidify the air inhaled by the patient, but these systems also humidify and / or heat the entire room, which may make the occupants uncomfortable. In addition, medical humidifiers may have stricter safety restrictions than industrial humidifiers.

[0078] Although many medical humidifiers are known, they may have one or more disadvantages. Some medical humidifiers may provide inadequate humidification, and some may be difficult or inconvenient to use by patients.

[0079] 2.2.3.5 Oxygen source

[0080] Experts in this area have recognized that exercising patients with respiratory failure provides long-term benefits, which slows the progression of the disease, improves quality of life and prolongs the patient's lifespan. However, most fixed forms of exercise, such as treadmills and stationary bicycles, are too strenuous for these patients. Therefore, it has long been recognized that mobility is needed. Until recently, this mobility has been facilitated by using small compressed oxygen tanks or cylinders mounted on a cart with small wheels. The disadvantage of these tanks is that they contain a limited amount of oxygen and are heavy, weighing about 50 pounds when installed.

[0081] Oxygen concentrators have been used for about 50 years to provide oxygen for respiratory therapy. Traditional oxygen concentrators are large and cumbersome, making ordinary life-saving activities difficult and impractical. Recently, companies that manufacture large, fixed oxygen concentrators have begun to develop portable oxygen concentrators (POCs). The advantage of POCs is that they can produce a theoretically unlimited supply of oxygen. In order to make these devices smaller for mobility, the various systems used to produce oxygen-rich gas need to be condensed. POCs seek to use the oxygen they produce as efficiently as possible to minimize weight, size, and power consumption. This can be achieved by delivering oxygen in a series of pulses or "boli", with each boli timed to coincide with the start of inspiration. This mode of treatment is called pulse oxygen delivery (POD) or demand mode, as opposed to traditional continuous flow delivery that is more suitable for fixed oxygen concentrators.

[0082] 2.2.3.6 Data Management

[0083] There may be many clinical reasons to obtain data to determine whether a patient being treated with a prescribed respiratory therapy is "compliant," such as that the patient has used their RPT device according to one or more "compliance rules." One example of a compliance rule for CPAP therapy is a requirement that the patient use the RPT device for at least four hours each night for at least 21 or 30 consecutive days in order for the patient to be considered compliant. To determine patient compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing the use of the RPT device for the patient's treatment, calculate usage over a predetermined time period, and compare it to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device according to the compliance rules, the healthcare provider may inform the patient of the third component of compliance.

[0084] There are other aspects of patient treatment that may benefit from the communication of treatment data to a third party or external system. For example, it would be useful to have performance data such as data indicating the effect of the treatment on the patient and / or data indicating the functionality of the patient interface to enable greater control over the treatment.

[0085] Existing methods of communicating and managing such data can be one or more of the following: expensive, time-consuming, and error-prone.

[0086] 2.2.3.7 Vent Technology

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

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

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

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

[0091]

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

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

[0094]

[0095] 2.2.4 Screening, diagnosis and monitoring systems

[0096] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and typically involves clinical specialists to apply the system. PSG typically involves placing 15 to 20 contact sensors on the patient to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep apnea has involved two nights of observation of the patient in the clinic, one night for pure diagnosis and a second night for the clinician to determine the treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep apnea due to the complex equipment required, which is difficult or even impossible for the patient to correctly attach for proper assessment.

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

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

[0099] The present technology is directed to providing medical devices for diagnosing, ameliorating, treating, or preventing breathing disorders with improved one or more of comfort, cost, efficacy, ease of use, and manufacturability.

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

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

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

[0103] One form of the present technology includes a patient interface comprising:

[0104] a pneumatic chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing,

[0105] a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that a flow of air at the treatment pressure is delivered at least to the entrance of the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the treatment pressure in the pneumatic chamber throughout the patient's breathing cycle,

[0106] a positioning and stabilizing structure configured to provide a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head;

[0107] One form of the present technology includes a positioning and stabilizing structure for a patient interface, which is convertible between a first pre-treatment configuration, in which the positioning and stabilizing structure can be worn by the patient as a headband, and a second configuration, in which the positioning and stabilizing structure can be used to apply a force to maintain the seal-forming structure in the proper position on the patient's face for effective respiratory therapy.

[0108] Another form of the present technology includes a patient interface having one or more sensors embedded, attached, or otherwise disposed therein and / or thereon for measuring patient data and / or device-related data for screening, monitoring, and / or diagnostic purposes.

[0109] One form of the present technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising: an upper fabric portion including an elastic circumferential band that is adapted to fit over a patient's head during use; and at least one lower fabric portion movably (e.g., hingedly) connected to the upper fabric portion; wherein at least one first lower fabric portion is stretchable relative to the upper fabric portion and is constructed and arranged to provide a force for maintaining a seal-forming structure of the patient interface in a therapeutically effective position on the patient's head.

[0110] One form of the present technology includes a patient interface comprising:

[0111] a pneumatic chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing,

[0112] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that a flow of air at a therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0113] a positioning and stabilizing structure configured to provide a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head;

[0114] The positioning and stabilization structures include:

[0115] an upper fabric portion comprising an elastic circumferential band for fitting over a patient's head in use; and

[0116] at least one lower fabric portion movably connected to the upper fabric portion;

[0117] At least one first lower fabric portion is stretchable relative to the upper fabric portion and is constructed and arranged to provide a force to maintain the seal-forming structure of the patient interface in a therapeutically effective position on the patient's head.

[0118] One form of the present technology includes a positioning and stabilizing structure for a patient interface comprising: a front section and a rear section forming a continuous loop of material, the front section forming a first bifurcated section having a first portion and a second portion; an upper fabric portion comprising an elastic circumferential band for fitting to a patient's head in use, the upper fabric portion being formed by the rear section and the first portion; and at least one lower fabric portion of the at least one lower fabric portion being movably connected to the upper fabric portion; wherein at least the first lower fabric portion is stretchable relative to the upper fabric portion and is constructed and arranged to provide a force to maintain a sealing-forming structure of the patient interface in a therapeutically effective position on the patient's head; and wherein the first lower fabric portion is capable of moving between a first position and a second position, the first lower fabric portion being configured to be proximal to the first portion and covering the patient's frontal bone in the first position, and the first lower fabric portion being configured to be distal to the first portion and covering the patient's cheek in the second position.

[0119] One form of the present technology includes a patient interface comprising:

[0120] a pneumatic chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing,

[0121] a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that a flow of air at a therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure in the pneumatic chamber throughout the patient's breathing cycle;

[0122] a positioning and stabilizing structure configured to provide a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head;

[0123] The positioning and stabilization structures include:

[0124] forming a front section and a rear section of a continuous loop of material, the front section forming a first bifurcated section having a first portion and a second portion;

[0125] an upper fabric portion comprising an elastic circumferential band for fitting to a patient's head in use, said upper fabric portion being formed from said rear section and said first portion; and

[0126] at least one lower fabric portion movably connected to the upper fabric portion;

[0127] wherein at least one first lower fabric portion of the at least one lower fabric portion is stretchable relative to the upper fabric portion and is constructed and arranged to provide a force to maintain the seal-forming structure of the patient interface in a therapeutically effective position on the patient's head; and

[0128] The first lower fabric portion is movable between a first position and a second position, the first lower fabric portion being configured to be proximal to the first portion and to cover the patient's forehead in the first position, and the first lower fabric portion being configured to be distal to the first portion and to cover the patient's cheek in the second position.

[0129] In examples of the foregoing aspects: (a) the first lower fabric portion is integral with the upper fabric portion; (b) the positioning and stabilizing structure is in the form of a headband; (c) the headband includes a first bifurcated section, the first bifurcated section including the first portion of the upper fabric portion and also including the first lower fabric portion, the first bifurcated section being located at the front of the headband; (d) the headband includes a second bifurcated section including the second portion of the upper fabric portion and also including the second lower fabric portion, the second bifurcated section being located at the rear of the headband; (e) the first The lower fabric portion is a seal retention band that is elastically stretchable along at least a portion of its length and is adapted to engage with an outer surface of the patient interface to maintain the seal-forming structure in the therapeutically effective position; (f) the seal retention band is more stretchable than the upper fabric portion; the seal retention band is adapted to be received in a channel of the patient interface; (g) the channel is formed in a pneumatic chamber of the patient interface; and / or (h) the seal retention band includes a port for connecting the seal-forming structure to an air circuit for supplying pressurized air to the patient.

[0130] In examples of the foregoing aspects: (a) the positioning and stabilizing structure includes a pair of lower fabric portions adapted to be coupled to each other and / or to an intermediate structure to provide the force; (b) the intermediate structure is a strap that, during use, holds the seal-forming structure in the therapeutically effective position; (c) the intermediate structure includes the seal-forming structure or a portion thereof; and / or (d) the lower fabric portions are coupled to each other or to the intermediate structure by one or more elastic hooks or straps.

[0131] In examples of the foregoing aspect: (a) at least one lower fabric portion includes one or more rigidified sections; and / or (b) at least one of the lower fabric portions has a higher rigidity in its middle section than at its ends.

[0132] In examples of the foregoing aspects: (a) the positioning and stabilizing structure includes one or more sensors disposed in or on the upper fabric portion and / or one or more lower fabric portions; (b) the positioning and stabilizing structure includes one or more actuators disposed in or on the upper fabric portion and / or one or more lower fabric portions; (c) at least one sensor or at least one actuator is partially exposed to the environment on an outer surface of the upper fabric portion or the one or more lower fabric portions; or partially exposed at a patient contact surface of the upper fabric portion or the one or more lower fabric portions so as to contact the patient's skin during use; (d) at least one sensor or at least one actuator is at least partially embedded between an outer layer of the upper fabric portion or the one or more lower fabric portions and a patient contact layer; (e) at least one sensor and / or at least one actuator includes at least partially a conductive layer formed by one or more conductive threads and / or one or more conductive threads. (f) the positioning and stabilizing structure includes one or more sensor holding structures for attaching corresponding sensors and / or actuators of the sensors and / or actuators; (g) the one or more sensor holding structures include one or more pockets to accommodate one or more corresponding sensors or actuators; (h) the positioning and stabilizing structure includes a wireless communication interface for sending data from the one or more sensors to one or more external computing devices, and / or for receiving data from the one or more external computing devices at the one or more actuators; and / or (i) the one or more sensors and / or one or more actuators include one or more of the following: an accelerometer; a gyroscope; a humidity sensor; a temperature sensor; a microphone; a camera; a pulse oximeter; an EEG sensor; an EMG sensor; an EOG sensor; a touch sensor; a vibration device; and an audio output device.

[0133] In examples of the foregoing aspects: (a) the first lower fabric portion is integral with the upper fabric portion; (b) the positioning and stabilizing structure is in the form of a headband; (c) the headband includes a first bifurcated section, the first bifurcated section including the first portion of the upper fabric portion and also including the first lower fabric portion, the first bifurcated section being located at the front of the headband; (d) the headband includes a second bifurcated section, the second bifurcated section including the second portion of the upper fabric portion and also including the second lower fabric portion, the second bifurcated section being located at the rear of the headband; (e) the first lower fabric portion (f) the seal retention band is more stretchable than the upper fabric portion; (g) the seal retention band is received in a channel of the patient interface; (h) the channel is formed in the outer surface of the pneumatic chamber; and / or (i) the seal retention band includes a port for connecting the pneumatic chamber inlet to an air circuit for supplying pressurized air to the patient.

[0134] In examples of the foregoing aspects: (a) the positioning and stabilizing structure includes a pair of lower fabric portions adapted to be coupled to each other or to an intermediate structure to provide the force; (b) the intermediate structure is a shoulder strap that, in use, engages with an outer surface of the pneumatic chamber or with an outer surface of the seal-forming structure; (c) the intermediate structure includes the pneumatic chamber and / or the seal-forming structure, or a portion thereof; (d) the pneumatic chamber and / or the seal-forming structure includes one or more protrusions or recesses for coupling one or more protrusions or recesses; (e) the lower fabric portions are coupled to each other and / or to the intermediate structure by one or more elastic hooks or straps; (f) at least one lower fabric portion includes one or more rigidified portions; and / or (g) at least one of the lower fabric portions has a higher rigidity in its middle section than at its ends.

[0135] In examples of the foregoing aspects: (a) the patient interface includes one or more sensors provided in or on the upper fabric portion, and / or the at least one lower fabric portion, and / or the pneumatic chamber, and / or the seal-forming structure; (b) the patient interface includes one or more actuators provided in or on the upper fabric portion, and / or the at least one lower fabric portion, and / or the pneumatic chamber, and / or the seal-forming structure; (c) at least one sensor and / or at least one actuator is partially exposed to the surrounding environment at an outer surface of the upper fabric portion or the at least one lower fabric portion; and / or is partially exposed at a patient contacting surface of the upper fabric portion or the at least one lower fabric portion so as to contact the patient's skin during use; (d) at least one sensor or at least one actuator is at least partially embedded between an outer layer of the upper fabric portion or the at least one lower fabric portion and a patient contacting layer; (e) at least one sensor and / or at least one actuator includes at least a portion of (f) the patient interface includes one or more sensor holding structures for attaching corresponding sensors and / or actuators; (g) the one or more sensor holding structures include one or more pockets to accommodate one or more corresponding sensors or actuators; (h) the patient interface includes a wireless communication interface for transmitting data from the one or more sensors to one or more external computing devices, and / or for receiving data from the one or more external computing devices at the one or more actuators; and / or (i) the one or more sensors and / or one or more actuators include one or more of the following: an accelerometer; a gyroscope; a humidity sensor; a temperature sensor; a microphone; a camera; a pulse oximeter; an EEG sensor; an EMG sensor; an EOG sensor; a touch sensor; a pressure sensor; a CO2 sensor; a vibration device; and an audio output device.

[0136] In examples of the foregoing aspects: (a) the pneumatic chamber includes a housing and has a housing inner surface and a housing outer surface, wherein the housing inner surface is arranged to be at the therapeutic pressure when in use and the housing outer surface is arranged to be at the ambient pressure when in use; (b) at least one lower fabric portion is engaged with at least a portion of the housing outer surface to maintain the seal-forming structure in the therapeutically effective position; (c) the channel is formed in the housing outer surface; (d) the housing is composed of a hard plastic material; and / or (e) the housing is composed of a transparent material.

[0137] One form of the present technology comprises a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising:

[0138] a headband formed at least in part from a fabric material and having an upper fabric portion movably connected to a first lower fabric portion, the headband including one or more sensors provided in or on the upper fabric portion and / or the first lower fabric portion;

[0139] The headband is wearable on the patient's head in a first configuration and a second configuration, wherein the first lower fabric portion is adjacent to the upper fabric portion and in the second configuration the first lower fabric portion is separated from the upper fabric portion and provides a force to maintain the sealing structure of the patient interface in a therapeutically effective position on the patient's head.

[0140] In examples of the foregoing aspects: (a) the positioning and stabilizing structure includes one or more actuators disposed in or on the upper fabric portion and / or the first lower fabric portion; (b) at least one sensor and / or at least one actuator is partially exposed to the surrounding environment at an outer surface of the upper fabric portion or the first lower fabric portion; and / or is partially exposed at a patient contact surface of the upper fabric portion or the first lower fabric portion so as to contact the patient's skin during use; (c) at least one sensor and / or at least one actuator is at least partially embedded between an outer layer of the upper fabric portion or the first lower fabric portion and a patient contact layer; (d) at least one sensor and / or at least one actuator includes a circuit formed at least in part by one or more conductive threads and / or one or more conductive ink traces; (e) the positioning and stabilizing structure includes a circuit for attaching one or more sensor retaining structures for corresponding ones of the sensors and / or actuators; (f) the one or more sensor retaining structures include one or more pockets to accommodate one or more corresponding sensors or actuators; (g) the positioning and stabilizing structure includes a wireless communication interface for sending data from the one or more sensors to one or more external computing devices, and / or for receiving data from the one or more external computing devices at the one or more actuators; and / or (h) the one or more sensors and / or one or more actuators include one or more of the following: an accelerometer; a gyroscope; a humidity sensor; a temperature sensor; a microphone; a camera; a pulse oximeter; an EEG sensor; an EMG sensor; an EOG sensor; a touch sensor; a vibration device; and an audio output device.

[0141] In examples of the foregoing aspects: (a) the first lower fabric portion is integral with the upper fabric portion; (b) the headband includes a first bifurcated section, the first bifurcated section including the first portion of the upper fabric portion and also including the first lower fabric portion, the first bifurcated section being located at the front of the headband; (c) the headband includes a second bifurcated section, the second bifurcated section including the second portion of the upper fabric portion and also including the second lower fabric portion, the second bifurcated section being located at the rear of the headband; (d) the first lower fabric portion is a sealing retention band that is elastically stretchable along at least a portion of its length, and adapted to engage with an outer surface of the patient interface to maintain the seal-forming structure in the therapeutically effective position; (e) the seal retention band is more stretchable than the upper fabric portion; (f) the seal retention band is adapted to be received in a channel of the patient interface; (g) the channel is formed in a pneumatic chamber of the patient interface; (h) the seal retention band includes a port for connecting the seal-forming structure to an air circuit for supplying pressurized air to the patient; and / or (i) the first lower fabric portion includes one or more rigidified portions; and / or (j) the first lower fabric portion has a higher rigidity in its middle section than at its ends.

[0142] One form of the present technology includes a patient interface comprising:

[0143] a pneumatic chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing,

[0144] a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that a flow of air at the treatment pressure is delivered at least to the entrance of the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the treatment pressure in the pneumatic chamber throughout the patient's breathing cycle,

[0145] The positioning and stabilising structure according to any of the preceding aspects or embodiments.

[0146] In examples of the foregoing aspects: (a) the patient interface also includes one or more sensors positioned in or on the inner surface of the pneumatic chamber; and / or (b) the one or more sensors include one or more of: a pressure sensor; a humidity sensor; a temperature sensor; and a CO2 sensor.

[0147] One form of the present technology includes a system for diagnosing and / or monitoring respiratory disorders, the system comprising: a patient interface according to any of the foregoing aspects or examples; and at least one computing device in communication with the patient interface to receive data from one or more sensors of the patient interface.

[0148] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that is complementary to the peripheral shape of the intended wearer.

[0149] One aspect of one form of the present technology is a method of manufacturing a device.

[0150] One aspect of some forms of the present technology is an easy-to-use medical device, for example for a person with no medical training, a person with clumsiness, limited vision, or a person with limited experience in using this type of medical device.

[0151] One aspect of one form of the present technology is a portable RPT device that can be carried by an individual (e.g., around the individual's home).

[0152] One aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, e.g., in soapy water, without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier canister that can be cleaned at the patient's home (e.g., in soapy water) without the need for specialized cleaning equipment.

[0153] The described methods, systems, apparatuses, and devices can be implemented to improve the functionality of a processor, such as a dedicated computer, a respiratory monitor, and / or a respiratory therapy device. Furthermore, the described methods, systems, apparatuses, and devices can provide improvements in the art of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0154] Of course, parts of each aspect may form sub-aspects of the present invention. Sub-aspects and / or aspects of each aspect may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

[0155] Other features of the inventive technology will become apparent by considering the information contained in the following detailed description, abstract, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0156] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals represent similar elements, including:

[0157] 4.1 Respiratory therapy system

[0158] Figure 1AA system is shown including a patient 1000 wearing a patient interface 3000 in the form of nasal pillows and receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient sleeps in a supine position.

[0159] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0160] Figure 1C A system is shown including a patient 1000 wearing a patient interface 3000 in the form of a full face mask, receiving a supply of air under positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying position.

[0161] 4.2 Respiratory system and facial anatomy

[0162] Figure 2A Shown is a schematic diagram of the human respiratory system including the nasal and oral chambers, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0163] Figure 2B A view of the human upper airway including the nasal chamber, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea is shown.

[0164] Figure 2C A front view of the face with several surface anatomical features labeled, including the upper lip, upper vermilion, lower vermilion, lower lip, mouth width, medial canthus, nasal ala, nasolabial folds, and corners of the mouth. The superior, inferior, radially inward, and radially outward directions are also labeled.

[0165] Figure 2D A side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge, nasal prominence, subseptal point, upper lip, lower lip, supramental point, nasal ridge, apex of the nose, and upper and lower ear bases. The superior-inferior and anterior-posterior directions are also labeled.

[0166] Figure 2E This is another lateral view of the head. The approximate locations of the Frankfurt horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0167] Figure 2FA bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermilion, nostrils, subseptal point, columella, pronasal point, long axis of the nostrils, and midsagittal plane.

[0168] Figure 2G A side view showing the surface features of the nose.

[0169] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0170] Figure 2I The medial anatomy of the nose is shown approximately a few millimeters from the midsagittal plane, showing, among other things, the septal cartilage and the medial crus of the greater alar cartilage.

[0171] Figure 2J Shown is a frontal view of the skull, including the frontal, nasal, and zygomatic bones. The nasal turbinates, as well as the maxilla and mandible, are also labeled.

[0172] Figure 2K A side view of the skull is shown, showing the outline of the head surface and several muscles. The following bones are shown: the frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also labeled. The following muscles are shown: the digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0173] Figure 2L An anterolateral view of the nose is shown.

[0174] 4.3 Patient Interface

[0175] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0176] Figure 3B A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and when compared to Figure 3C The curvature magnitude shown is relatively large in comparison.

[0177] Figure 3C A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and when compared to Figure 3B The curvature magnitude shown is of relatively small magnitude in comparison.

[0178] Figure 3D A schematic diagram of a cross section through a structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0179] Figure 3E A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and when compared to Figure 3F The curvature magnitude shown is of relatively small magnitude in comparison.

[0180] Figure 3F A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and when compared to Figure 3E The curvature magnitude shown is relatively large in comparison.

[0181] Figure 3G The cushion of a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome area and the saddle area are indicated.

[0182] Figure 3H A cushion for a face mask is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle regions and one dome region are indicated.

[0183] Figure 3I A surface having a structure with one-dimensional holes on the surface is shown. The plane curves shown form the boundaries of the one-dimensional holes.

[0184] Figure 3J Shown through Figure 3I The surface shown is in the cross section of the structure. Figure 3I A two-dimensional hole is defined in the structure.

[0185] Figure 3K Shown Figure 3I A perspective view of the structure of , including two-dimensional holes and one-dimensional holes. Also shown is the Figure 3I The surface defining the two-dimensional pores in the structure.

[0186] Figure 3L A mask is shown with an inflatable bladder as a cushion.

[0187] Figure 3M Shown through Figure 3L FIG. 1 is a cross-section of a mask of FIG. 1 and shows the inner surface of the airbag. The inner surface defines a two-dimensional hole in the mask.

[0188] Figure 3N Shown through Figure 3L Another cross section of the mask. The inner surface is also indicated.

[0189] Figure 3O The diagram illustrates the left-hand rule.

[0190] Figure 3P The diagram illustrates the right-hand rule.

[0191] Figure 3Q The left ear is shown, including the left helix.

[0192] Figure 3R The right ear is shown, including the right helix.

[0193] Figure 3S A right-handed helix is ​​shown.

[0194] Figure 3T A view of a mask is shown including symbols for the twisting of the spatial curve defined by the edge of the sealing membrane in different regions of the mask.

[0195] Figure 3U A view of the pneumatic chamber 3200 is shown, illustrating the sagittal plane and the medial contact plane.

[0196] Figure 3V Shown Figure 3U A view of the rear of the pneumatic chamber. The view is perpendicular to the middle contact plane. Figure 3V The sagittal plane in the middle divides the pneumatic chamber into two equal parts: left and right.

[0197] Figure 3W Shown through Figure 3V The cross section of the pneumatic chamber is Figure 3V The image is taken in the sagittal plane shown. A "mid-contact" plane is shown. This mid-contact plane is perpendicular to the sagittal plane. The direction of the mid-contact plane corresponds to the direction of a chord 3210, which lies in the sagittal plane and just contacts the liner of the pneumatic chamber at two points on the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the liner in this area, the mid-contact plane can be a tangent at the upper and lower points.

[0198] Figure 3X Shown Figure 3U The pneumatic chamber 3200 is in the position of use on the face. When the pneumatic chamber is in the use position, the sagittal plane of the pneumatic chamber 3200 roughly coincides with the mid-sagittal plane of the face. When the pneumatic chamber is in the use position, the median contact plane generally corresponds to the 'facial plane'. Figure 3X In FIG, the pneumatic chamber 3200 is the pneumatic chamber of the nasal mask, and the upper point 3220 is located approximately on the bridge of the nose, while the lower point 3230 is located on the upper part of the lip.

[0199] Figure 4A is a front perspective view of a positioning and stabilizing structure for a patient interface in accordance with one form of the present technology.

[0200] Figure 4Bis a side view of a patient interface in accordance with one form of the present technology incorporating Figure 4A The positioning and stabilizing structure of the device is shown in the position of use on the patient's head.

[0201] Figure 4C yes Figure 4B Front perspective view of a patient interface showing the use position on a patient's head.

[0202] Figure 4D It's a picture Figure 4A Close up view of the support area for positioning and stabilizing the structure.

[0203] Figure 4E yes Figure 4A Side view of the positioning and stabilizing structure worn by a patient in a first configuration.

[0204] Figure 4F yes Figure 4A Side view of the positioning and stabilizing structure worn by a patient in a second configuration.

[0205] Figure 5A is a side view of a patient interface according to one form of the present technology, shown in the position of use on a patient's head.

[0206] Figure 5B It is used to connect the seal to the structure Figure 5A Schematic diagram of the positioning and stabilizing structure of the patient interface.

[0207] Figure 6 is a front perspective view of a patient interface according to one form of the present technology, shown in a position of use on a patient's head.

[0208] Figure 7A is a side view of a patient interface according to one form of the present technology, shown in the position of use on a patient's head.

[0209] Figure 7B It is used to connect the seal to the structure Figure 7A Schematic diagram of the positioning and stabilizing structure of the patient interface.

[0210] Figure 7C yes Figure 7A Front perspective view of a patient interface showing the use position on a patient's head.

[0211] Figure 8A is a front perspective view of a patient interface according to one form of the present technology, shown in a position of use on a patient's head.

[0212] Figure 8B yes Figure 8A Close-up side view of the pneumatic chamber of the patient interface.

[0213] Figure 9A A positioning and stabilising structure of a patient interface according to one form of the present technology is shown in a first use position on a patient's head.

[0214] Figure 9B Shown Figure 9A The positioning and stabilizing structure of the patient interface is in a second use position on the patient's head as part of the patient interface.

[0215] Figure 9C It passes through Figure 9A Schematic cross section of a portion of a positioning and stabilizing structure.

[0216] 4.4RPT device

[0217] Figure 10A One form of RPT device according to the present technology is shown.

[0218] Figure 10B Schematic diagram of the pneumatic path of an RPT device according to one form of the present technology. Upstream and downstream directions are indicated with reference to the blower and the patient interface. The blower is defined as upstream of the patient interface and the patient interface is defined as downstream of the blower, regardless of the actual flow direction at any given moment. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0219] Figure 10C is a schematic diagram of the electrical components of an RPT device according to one form of the present technology.

[0220] Figure 10D is a schematic diagram of an algorithm implemented in an RPT device according to one form of the present technology.

[0221] Figure 10E is a diagram illustrating a form of the present technology Figure 10D A flowchart of a method performed by a treatment engine module.

[0222] 4.5 Humidifier

[0223] Figure 11A Shown is an isometric view of a humidifier according to one form of the present technology.

[0224] Figure 11B An isometric view of a humidifier in accordance with one form of the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0225] Figure 11C Shown is a schematic diagram of a humidifier according to one form of the present technology. DETAILED DESCRIPTION

[0226] Before describing the present technology in more detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terminology used in the present invention is only used to describe the specific examples discussed herein and is not intended to be limiting.

[0227] The following description is provided for various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. Additionally, in any one of the examples, any single feature or combination of features may constitute another example.

[0228] 5.1 Treatment

[0229] In one form, the present technology includes a method for treating a breathing disorder comprising applying positive pressure to an airway entrance of a patient 1000 .

[0230] In some examples of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0231] In some examples of the present technology, mouth breathing is limited, restricted, or prevented.

[0232] 5.2 Respiratory therapy system

[0233] In one form, the present technology includes a respiratory therapy system for treating respiratory disorders.The respiratory therapy system may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0234] 5.3 Patient Interface

[0235] refer to Figure 3A , a non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, a pneumatic chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to a form of air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance to the patient's airway so as to maintain a positive pressure at the airway entrance of the patient 1000. The sealed patient interface 3000 is therefore suitable for the delivery of positive pressure therapy.

[0236] Other examples of non-invasive patient interfaces 6000, 7000, 8000, 9000, 10000, and 11000 are also available at Figures 4A-4F, 5A-5C, 6, 7A-7C, 8A-8B and 9A-9C, and will be described in further detail below.

[0237] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0238] A patient interface according to one form of the present technology is constructed and arranged to provide air at a positive pressure of at least 6 cmH20 relative to ambient.

[0239] A patient interface according to one form of the present technology is constructed and arranged to provide air at a positive pressure of at least 10 cmH20 relative to ambient.

[0240] A patient interface according to one form of the present technology is constructed and arranged to provide air at a positive pressure of at least 20 cmH20 relative to ambient.

[0241] 5.3.1 Sealing structure

[0242] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where sealing is likely to occur. The area where sealing actually occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given course of treatment, depending on a number of factors, including, for example, where the patient interface is placed on the face, the tension in the positioning and stabilizing structures, and the shape of the patient's face.

[0243] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0244] In some forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0245] A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, and resilient material such as silicone.

[0246] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 that is suitable for large heads but not small heads, and another form of seal-forming structure that is suitable for small heads but not large heads.

[0247] 5.3.1.1 Sealing mechanism

[0248] In one form, the seal-forming structure includes a sealing flange that utilizes a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the pneumatic chamber 3200, acting on its underside to urge the sealing flange into tight sealing engagement with the face. The pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilizing structure.

[0249] In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange comprises a relatively thin member having a thickness of less than about 1 mm, for example, about 0.25 mm to about 0.45 mm, that extends around the periphery of the pneumatic chamber 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the pneumatic chamber 3200 and extends around at least a portion of the perimeter. The support flange is or comprises a spring-like element and functions to support the sealing flange and prevent it from bending during use.

[0250] In one form, the seal-forming structure may comprise a compression seal or a gasket seal that is constructed and arranged to be in a compressed state in use, for example as a result of elastic tension in the positioning and stabilising structure.

[0251] In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is maintained in tension, for example, by an adjacent area of ​​the sealing flange.

[0252] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0253] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tensioning portion, and a portion having a tacky or adhesive surface.

[0254] 5.3.1.2 Nose bridge or nasal ridge area

[0255] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the nasal bridge or nasal ridge region of the patient's face.

[0256] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over a nasal bridge or nasal ridge region of the patient's face.

[0257] 5.3.1.3 Upper lip area

[0258] In one form, the non-invasive patient interface 3000 includes a seal-forming structure, the seal-forming portion forming a seal on the upper lip region (ie, upper lip) of the patient's face when in use.

[0259] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal on an upper lip region of a patient's face in use.

[0260] 5.3.1.4 Chin area

[0261] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the chin region of the patient's face when in use.

[0262] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on a chin region of a patient's face in use.

[0263] 5.3.1.5 Forehead area

[0264] In one form, the seal-forming structure forms a seal on the forehead area of ​​the patient's face during use.In this form, the pneumatic chamber can cover the eyes during use.

[0265] 5.3.1.6 Nasal pillows

[0266] In one form, the seal-forming structure of the non-invasive patient interface 3000 comprises a pair of nasal puffs or pillows, each constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0267] A nasal pillow according to one aspect of the present technology includes: a frustoconical body, at least a portion of which forms a seal against the bottom surface of a patient's nose; a stem; and a flexible region on the bottom surface of the frustoconical body and connecting the frustoconical body to the stem. Furthermore, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the bottom of the stem. The flexible regions can cooperate to facilitate a universal joint structure that can adapt to relative movement of both the displacement and angle between the frustoconical body and the structure to which the nasal pillows are connected. For example, the position of the frustoconical body can be moved axially toward the structure to which the stem is connected.

[0268] 5.3.2 Pneumatic chamber

[0269] In the area where the seal is formed during use, the pneumatic chamber 3200 has a perimeter that is shaped to complement the surface contours of an average person's face. In use, the boundary edge of the pneumatic chamber 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 can extend around the entire perimeter of the pneumatic chamber 3200 during use. In some embodiments, the pneumatic chamber 3200 and the seal-forming structure 3100 are formed from a single, uniform piece of material.

[0270] In some forms of the present technology, the pneumatic chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the pneumatic chamber. Such forms tend to be less obtrusive and / or more comfortable to the wearer, which can improve compliance with treatment.

[0271] In some forms of the present technology, the pneumatic chamber 3200 is constructed of a transparent material, such as clear polycarbonate. The use of a transparent material can reduce obstructiveness of the patient interface and help improve compliance with treatment. The use of a transparent material can help the clinician observe how the patient interface is positioned and functioning.

[0272] In some forms of the present technology, the pneumatic chamber 3200 is constructed of a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.

[0273] 5.3.3 Positioning and stabilizing the structure

[0274] The seal-forming structure 3100, 6100, 7100, 8100, 9100, 10100, 11100 of the patient interface 3000, 6000, 7000, 8000, 9000, 10000, 11000 of the present technology may be maintained in a sealed position during use by the positioning and stabilising structure 3300, 6300, 7300, 8300, 9300, 10300, 11300.

[0275] In one form, the positioning and stabilising structure 3300, 6300, 7300, 8300, 9300, 10300, 11300 provides a retaining force that is at least sufficient to overcome the positive pressure in the pneumatic chamber 3200, 6200, 7200, 8200, 10200, 11200 to lift the face away.

[0276] In one form, the positioning and stabilising structure provides a retaining force to overcome the effects of gravity on the patient interface.

[0277] In one form, the positioning and stabilizing structure provides a retaining force as a safety margin to overcome the potential effects of damaging forces on the patient interface, such as from tube drag or accidental interference with the patient interface.

[0278] In one form of the present technology, a positioning and stabilizing structure is provided that is configured in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilizing structure has a small lateral or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure includes at least one flat strap.

[0279] In one form of the present technology, a positioning and stabilizing structure is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a supine sleeping position with the back area of ​​the patient's head on a pillow.

[0280] In one form of the present technology, a positioning and stabilizing structure is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a side sleeping position with the side area of ​​the patient's head on a pillow.

[0281] In one form of the present technology, the positioning and stabilizing structure comprises a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. Alternatively or in addition, the strap may comprise fiber filler (e.g., polyester fiber filler), non-woven filler, foam filler, high density upholstery foam, compressed polyester, medium density polyurethane antimicrobial foam, high density polyurethane foam, dry fast open cell foam, or a combination thereof. Thus, the strap is not too large and bulky to prevent the patient from lying in a side-lying position. Additionally, the strap is stretchable and flexible.

[0282] In some forms of the present technology, the positioning and stabilizing structure includes a strap that is extendable, such as elastically extendable. For example, the strap can be configured to be in a tensioned state when in use and to direct a force to cause the seal-forming structure to seal with a portion of the patient's face.

[0283] For example, reference Figures 4A-4F The patient interface 6000 includes a positioning and stabilizing structure or headband 6300, which includes an upper fabric portion 6310 including a peripheral band for fitting to a patient's head during use. A first lower fabric portion 6320 is movably connected (e.g., hingedly, articulatedly, pivotally, etc.) to the upper fabric portion 6310. For example, the first lower fabric portion 6320 can be integral with the upper fabric portion 6310. Alternatively, the first lower fabric portion 6320 can be connected to the upper fabric portion 6310, for example, by sewing, ultrasonic welding, or other techniques. For example, the respective ends of the first lower fabric portion 6320 can be joined at respective seams 6322 and 6324 located near bifurcation points 6312 and 6314 on opposite lateral sides of the positioning and stabilizing structure 6300. Because the fabric portions 6310 and 6320 are stretchable, the length of each portion during use is equal to or greater than its respective resting length. Thus, wrinkles in the fabric material of portions 6310, 6320 are avoided.

[0284] The positioning and stabilizing structure 6300 is used to apply force to the seal-forming structure 6100. The seal-forming structure 6100 may be a cushion mask having a pneumatic chamber 6200 and a connection port 6600 for connecting the pneumatic chamber 6200 to the air circuit 4170.

[0285] In this example, the positioning and stabilising structure 6300 is formed as a strap having a front or anterior section 6302 and a rear or posterior section 6304, wherein the front section 6302 is bifurcated (at points 6312, 6314) such that a first bifurcation forms a first portion of an upper fabric portion 6310 and a second bifurcation forms a first lower fabric portion 6320. Thus, the upper fabric portion 6310 forms a first strap or band that, in use, can be encircled around the patient's forehead, as shown. Figure 4B As shown, the first lower fabric portion 6320 forms a downwardly stretchable second strap or band to directly or indirectly engage with the seal-forming structure 6100 to provide a force to maintain the seal-forming structure 6100 in a therapeutically effective position on the patient's head.

[0286] In some forms, the front section 6302 may have substantially the same width as the back section 6304. In other words, the width of the first portion of the upper fabric portion 6310 and the first lower fabric portion 6320 may be substantially equal to the width of the back section 6304. This may allow the positioning and stabilizing structure 6300 to have a substantially constant material width at any point along the positioning and stabilizing structure 6300.

[0287] Figures 4A-4F The configuration allows positioning and stabilizing structure 6300 for wearing as a headband, with both fabric portions 6310, 6320 surrounding the patient's forehead, so that the patient can become accustomed to the feel of structure 6300 before commencing treatment. The upper fabric portion 6310 can be configured to encircle the patient's forehead, such that the front section (or front portion) of the upper fabric portion 6310 is configured to engage the front portion of the patient's head, and the rear section (or rear portion) of the upper fabric portion 6310 is configured to engage the rear portion of the patient's head. Similarly, the lower fabric portion 6320 can be configured to encircle the patient's forehead, such that the rear section (or rear portion) of the first lower fabric portion 6320 is configured to engage the rear portion of the patient's head. In this first position, the front section of the upper fabric portion 6310 (i.e., forming part of the front section 6302) and the lower fabric portion 6320 can be positioned proximate to each other (e.g., adjacent, close together, etc.) on the patient's forehead. In use, the front section (or front portion) of the first lower fabric portion 6320 is configured to move to the second position and cover the cheek area of ​​the patient's face, preferably the upper cheek area, and extend between the top of the patient's ears and the patient's eyes. In addition, before starting treatment, the first lower fabric portion 6320 can be easily pulled downward (such as Figure 4E and Figure 4F ), whereby it can engage with the pneumatic chamber 6200 and provide a tensioning force to the pneumatic chamber 6200 (e.g., by nesting within an external groove or channel 6210 of the pneumatic chamber 6200). Figures 4B-4D ). In the second position, the first lower fabric portion 6320 can be positioned proximate to the patient's mouth (e.g., covering the patient's upper lip), while the upper fabric portion 6310 can remain in substantially the same position (e.g., on the patient's forehead), such that the first lower fabric portion 6320 is at least partially spaced apart from the upper fabric portion. For example, the bifurcated sections of the front section 6302 can be spaced apart from each other (e.g., to tuck the patient's head and avoid obstructing the patient's eyes). However, the front section 6302 and the rear section 6304 remain continuously formed in the second position, and the combined width of the spaced-apart front sections 6302 remains substantially equal to the width of the rear section 6304. Prior to commencing treatment, the positioning and stabilizing structure 6300 can be worn without connecting the air circuit 4170 and / or turning on the pressure generator 4140 of the RPT device 4000. This allows the patient to become accustomed to wearing the patient interface 6000 without experiencing any discomfort from the positive pressure provided by the pressure generator 4140. Thus, the patient is able to gradually transition to respiratory therapy, thereby increasing the likelihood of compliance once therapy actually begins.

[0288] Thus, the positioning and stabilizing structure 6300 can be easily transformed by a simple pivoting motion between a first portion or non-therapeutic configuration (e.g., for monitoring and / or diagnostic purposes when sensors are provided in the positioning and stabilizing structure 6300, as will be discussed below) and a second position or therapeutic or pre-therapeutic configuration.

[0289] Some forms of the present technology may include a filling structure attached to or integrated with either or both of the upper fabric portion 6310 and the lower fabric portion 6320. The filling structure may include a soft foam or a soft woven and / or knitted fabric or non-woven fabric that is integrated into or secured to the upper and / or lower fabric portions 6310, 6320. Alternatively, the filling structure may include one or more sleeves of such cushioning material provided around the exterior of the upper fabric portion 6310 and / or the lower fabric portion 6320. The filling structure provides improved comfort for the wearer.

[0290] In some forms of the present technology, the lower fabric portion 6320 may be more stretchable than the upper fabric portion 6310, thereby enabling the lower fabric portion 6320 to be more easily stretched downward, such as Figure 4F, so as to engage with the pneumatic chamber 6200. For example, the stretch properties of portions 6310, 6320 can be adjusted by using different types of knitting, such as warp knitting, weft knitting, or a combination of both. In one example, a narrow double-woven warp knit fabric can be used to form the lower fabric portion 6320 or at least a portion thereof to provide additional stretch and length relative to the upper fabric portion 6310 for engagement with the pneumatic chamber 6200.

[0291] The upper fabric portion 6310 and the lower fabric portion 6320 can be made of the same fabric (or fabrics). The fabric can be nylon, polyester, polypropylene (PP), spandex, or a combination of any two or more thereof. The elasticity can be varied by changing the fabric material combination (i.e., blending ratio), yarn count, yarn density, yarn size, and / or the steps and conditions of the fabric manufacturing process.

[0292] The fabric may include a core yarn comprising a core and a covering layer. The core yarn may comprise polyurethane fibers and / or elastomeric fibers (such as rubber fibers and silicone fibers) to achieve the desired stretchability, while the covering layer may be made of nylon, polyester, and / or polypropylene. In addition, the filaments used for the covering layer may be textured continuous filaments to achieve better softness, durability, better thermal insulation, high permeability, and good moisture transport (i.e., moisture wicking).

[0293] The width of each of the upper fabric portion 6310 and the lower fabric portion 6320 can be less than 40 mm. In some embodiments, the width is less than 30 mm. The width can be greater than 3 mm. The fabric portions 6310 and 6320 can have different widths. For example, the upper fabric portion 6310 can be wider to accommodate sensors and circuitry (e.g., greater than 10 mm and less than 30 mm, or greater than 15 mm and less than 25 mm), and the lower fabric portion 6320 can be narrower to avoid visual obstruction (e.g., less than 10 mm, or less than 15 mm).

[0294] The upper fabric portion 6310 can be configured to have a lower stretchability and a greater thickness than the lower fabric portion 6320 to ensure that the upper fabric portion 6310 maintains its shape, while the lower fabric portion 6320 is configured to be more easily stretched downward (where the pneumatic chamber 6200 is maintained for use). For example, the thickness of the fabric used for the upper fabric portion 6310 can be in the range of about 0.30 mm to about 1.50 mm, and the thickness of the fabric used for the lower fabric portion 6320 can be in the range of about 0.20 mm to about 1.00 mm.

[0295] The positioning and stabilizing structure 6300 may be constructed by weaving a strip of material having bifurcations at 6312, 6314, and the ends of the strip of material may then be attached (e.g., Figure 4A) at the joint 6332 shown in ) to form a positioning and stabilizing structure 6300.

[0296] In some embodiments, two separate parts can be woven and then attached together by any suitable means. For example, a first (upper) peripheral band can be joined to a second (lower) peripheral band by a joining section or seam extending partially around their respective circumferences, leaving at least one unjoined section (e.g., spanning between bifurcation points 6312 and 6314, or between seams 6322 and 6324) where the two bands are separable. The first peripheral band and the second peripheral band can be formed from different textile materials and / or can have different degrees of stretch. The joint between the two parts can be formed by knitting, stitching, adhesive (including adhesive patches that can be rigid or elastically deformable), ultrasonic bonding, heat sealing, or a combination of any two of these.

[0297] In some forms of the present technology, the degree of stretch or stiffness of the first lower fabric portion 6320 may vary along its length. Figure 4D , the middle section 6326 of the first lower fabric portion 6320, which is arranged to directly engage the pneumatic chamber 6200 (e.g., within the groove 6210 thereof), can be more rigid than the remainder of the first lower fabric portion 6320 to provide greater support at the point of direct engagement. Other portions of the first lower fabric portion 6320 can be rigid to provide greater stability of the headband 6300 during use and / or to redirect tensioning forces to prevent the first lower fabric portion 6320 from traveling upward over the patient's cheekbones and covering the eyes.

[0298] In some forms of the present technology, one or more rigidifiers may be provided to selectively vary the rigidity of the first lower fabric portion 6320. These may be attached to the first lower fabric portion 6320, or inserted between its layers. For example, the middle section 6326 may include rigidifiers laminated to or embedded between the layers of the lower fabric portion 6320. Alternatively, thermosetting yarns may be used to provide selective rigidification in the middle section 6326. The fabric may also be rigidified at other portions of the lower fabric portion 6320, such as along the side sections that will contact the patient's face during use, for example using a coating, a laminate, a rigidizing thread sewn into the fabric, or any similar means.

[0299] In some forms, the positioning and stabilizing structure may include a patient contacting structure having one or more elastic straps extending therefrom to engage with a harness that holds the seal-forming structure in place.

[0300] For example, Figure 5AAs shown, the patient interface 7000 includes a positioning and stabilizing structure 7300, which in turn includes a patient contacting structure 7301 that cooperates with a back strap 7329 to provide tension to the seal-forming structure 7100 to maintain the seal-forming structure 7100 in a therapeutically effective position on the patient's head. The patient interface 7000 also includes a pneumatic chamber 7200 having a connection port 7600 for connecting the patient interface 7000 to the air circuit 4170.

[0301] In one form of the present technology, a positioning and stabilizing structure 7300 includes an upper fabric portion 7310 and two lower fabric portions movably (e.g., hingedly, articulatedly, pivotally, etc.) connected to the upper fabric portion 7310. The positioning and stabilizing structure 7300 also includes a rear section 7304 configured to be anchored against the posterior surface of the patient's neck. The upper fabric portion 7310 is adapted to wrap around the patient's head in a region above the supra-auricular base of the patient's head during use.

[0302] The lower fabric portion may include a first arm 7326 and a second arm 7328. Each arm may have a hook, such as hook 7349 ( Figure 5B ) to engage with corresponding clips 7330 located on the back strap 7329. For example, the hook 7349 can be formed from a length of elastic yarn material, with its opposite ends 7346, 7348 located within corresponding channels 7342 and 7344 on the second arm 7328. By forming the hook 7349 from an elastic material, it can be easily extended to engage with the clip 7330, while also being able to be retracted into the channels 7342, 7344 when the patient interface 7000 is not in use and the seal-forming structure 7100 does not need to be attached. Although not shown in FIG. Figure 5A and 5B , but it will be understood that the same structure (or a similar structure) can be provided on the first arm 7326 to engage with a further clip on the opposite side of the strap 7329 so that the two hook-clip pairs cooperate to hold the strap 7329, and therefore the seal-forming structure 7100, in position on the patient's head.

[0303] Hook 7349 Figure 5A and Figure 5B 7328 as extending from the exterior (non-patient contacting) surface of the second arm 7328. It should be understood that in some forms of the present technology, the hook 7349 may alternatively extend from a channel located on the interior (patient contacting) surface of the second arm 7328, although it is generally desirable to use a Figure 5A and Figure 5B External arrangement shown for greater patient comfort.

[0304] The first arm 7326 and the second arm 7328 can each vary in stiffness relative to the upper fabric portion 7310 and the rear portion 7304 of the patient contacting structure 7301 along at least a portion of their length. For example, each of the first arm 7326 and the second arm 7328 can be stiffer than the upper fabric portion 7310 and the rear portion 7304 at least in their midsection. By providing increased stiffness at least in the midsection of both arms 7326 and 7328, the positioning and stabilizing structure 7300 provides increased support for the seal-forming structure 7100, making it less prone to movement during respiratory therapy and providing a better dynamic seal. Furthermore, similar to the rigidification described above with respect to the positioning and stabilizing structure 6300, selectively increasing the stiffness in the arms 7326 and 7328 helps direct the tensioning force vector away from the patient's eyes during use. In some embodiments, the arms 7326 and 7328 can be formed using thermoset yarn to provide the desired stiffness.

[0305] In one form, one or more rigid members may be provided in the arms 7326, 7328. The rigid members may be semi-rigid. In other words, the rigid members may be stiffer than the fabric material used to form the arms 7326, 7328 and / or the upper fabric portion 7310, but not completely stiff. In this way, they can provide structure to the arms 7326, 7328, but be flexible so that they can bend. The patient and / or medical professional can adjust or bend the rigid members to provide customized support for an individual patient. The rigid members may also start out semi-rigid (in other words, the rigid members may be semi-rigid at the beginning or initially) and may become rigid after a period of time. For example, a medical professional may adjust the shape of the rigid members so that the positioning and stabilizing structure 7300 is adapted to the face of an individual patient. The rigid members may then be treated (e.g., heat treated) so that they are set to their shape. In other words, the rigidity of the rigid members can be changed. Thus, the stiffness of the arms 7326, 7328 also varies and can be selectively increased to provide customized support for a single patient (or multiple patients).

[0306] In one form of the present technology, Figure 6 As shown, the patient interface 8000 includes a seal-forming structure 8100 that includes one or more clips 8220 that can engage with corresponding hooks on the positioning and stabilizing structure 7300 to maintain the seal-forming structure 8100 in a therapeutically effective position on the patient's head. For example, the patient contacting structure 7301 of the positioning and stabilizing structure 7300 can cooperate with such a seal-forming structure 8100 to form a patient interface 8000 that also includes a pneumatic chamber 8200 and a connection port 8600 for connecting to the air circuit 4170. Thus, the patient contacting structure 7301 can be combined with an intermediate structure such as Figure 5A and Figure 5B The back strap arrangement may be used with the illustrated back strap to hold the seal-forming structure, or may be engaged directly with the seal-forming structure (where the seal-forming structure includes a suitable engagement mechanism, such as the clips 8220 of the structure 8100). The back strap arrangement is advantageous in that it may be used with many types of existing seal-forming structures 7100, and Figure 6 The advantage of the structure in is that, due to the direct connection with the sealing forming structure 8100, a more stable support can be provided for the sealing forming structure 8100.

[0307] In some embodiments, a plurality of clips 8220 may be provided at a plurality of different locations on the seal-forming structure 8100, or on another structure connected thereto (such as the pneumatic chamber 8200), so that the tension in the positioning and stabilizing structure 7300 can be adjusted by attaching the hooks 7349 to the clips 8220 at different locations. Figure 5A and 5B Multiple clips 7330 are provided at multiple different locations on the shoulder strap 7329.

[0308] In another form of the present technology, Figures 7A-7C As shown, the patient interface 9000 includes a positioning and stabilizing structure 9300, which in turn includes a patient contacting structure 9301 that cooperates with a back strap 9329 to provide tension to the seal-forming structure 9100 to maintain the seal-forming structure 9100 in a therapeutically effective position on the patient's head. The patient interface 9000 also includes a pneumatic chamber 9200 having a connection port 9600 for connecting the patient interface 9000 to the air circuit 4170. The positioning and stabilizing structure 9300 of the patient interface 9000 is similar to the positioning and stabilizing structure 7300 of the patient interface 7000, but has at least a different engagement mechanism for connecting the back strap 9329 to the patient contacting structure 9301.

[0309] In one form of the present technology, the positioning and stabilizing structure 9300 includes an upper fabric portion 9310 and a lower fabric portion that is movably (e.g., hingedly, articulatedly, pivotally, etc.) connected to (e.g., integral with) and extends from the upper fabric portion 9310. The positioning and stabilizing structure 9300 also includes a rear portion 9304 configured to anchor against the posterior surface of the patient's neck or occipital bone. The upper fabric portion 9310 is adapted to wrap around the patient's head in the region of the supra-auricular base point above the patient's head during use.

[0310] The lower fabric portion may include a first arm 9326 and a second arm 9328. Each arm may have a hook, such as from the second arm 9328 ( Figure 7B) to engage with a corresponding hook (not shown) located on the back strap 9329. For example, the hook 9349 can be an elastic strap that is received in the channel 9342 on the outer (non-patient contacting) surface of the second arm 9328, and it can extend from the channel 9342 to engage with a clip on the back strap 9329. When the strap 9349 is released, it at least partially retracts into the channel 9342.

[0311] The strap 9349 can be attached to the back strap 9329 by a hook and loop arrangement. For example, a first patch carrying a hook (or loop) on its surface can be provided on the strap 9349, and a second patch carrying a loop (or hook) on its surface can be provided on the back strap 9329, so that the patient can attach the strap 9349 to the back strap 9329 by bringing the first patch into contact with the second patch. In addition, the tension can be adjusted by changing the relative position of the first patch and the second patch when in contact. The hook and loop arrangement may include a hook component comprising nanoscale protrusions and a loop component comprising a nanofiber pile fabric. One such hook and loop system is sold by Teijin Corporation under the trademark FASTENANO. In another possible arrangement, the strap 9349 may include an array of spikes or similar protrusions that can be embedded in the material of the back strap 9329 for attaching the back strap.

[0312] Although not in Figures 7A-7C , but it will be appreciated that the same structure (or a similar structure) may be provided on the first arm 9326 to engage with another clip on the opposite side of the shoulder strap 9329 such that the two hook-clip pairs cooperate to hold the shoulder strap 9329 and the seal-forming structure 9100 in position on the patient's head.

[0313] The first arm 9326 and the second arm 9328 can each vary in stiffness relative to the first elastic fabric portion 9310 and the rear portion 9304 of the patient contacting structure 9301 along at least a portion of their lengths. For example, each of the first arm 9326 and the second arm 9328 can be more rigid than the first elastic fabric portion 9310 and the rear portion 9304 at least in their midsections. By providing increased stiffness at least in the midsections of the two arms 9326, 9328, the positioning and stabilizing structure 9300 provides increased support for the seal-forming structure 9100, making it less prone to movement during respiratory therapy. Advantageously, the arms 9326, 9328 can be formed using thermosetting yarns to provide the desired stiffness. Alternatively or in addition, similar rigidifying mechanisms as discussed above can be employed, such as providing a rigidizer attached to or embedded between the layers of the arms 9326, 9328.

[0314] In another form of the present technology, Figure 8A and 8BAs shown, the patient interface 10000 includes a positioning and stabilizing structure 10300 and a pneumatic chamber 10200 having a connection port 10600 for connecting the patient interface 10000 to the air circuit 4170. The positioning and stabilizing structure 10300 is constructed and arranged to provide a force to maintain the seal-forming structure 10100 of the patient interface in a therapeutically effective position on the patient's head.

[0315] In one form of the present technology, the positioning and stabilizing structure 10300 includes an upper fabric portion 10310 and a lower fabric portion that is movably (e.g., hingedly, articulatedly, pivotally, etc.) connected (e.g., integrally with) and extends from a first elastic fabric portion 10310. The positioning and stabilizing structure 10300 also includes a rear portion 10304 configured to be anchored against a posterior surface of a patient's neck. The first elastic fabric portion 10310 is adapted to wrap around the patient's head, such as in the area of ​​the supra-auricular base of the patient's head, during use.

[0316] The lower fabric portion may include a first arm 10326 and a second arm 10328. Each of the first arm 10326 and the second arm 10328 can be elastically coupled to the pneumatic chamber 10200 in use to hold the seal-forming structure 10100 in place. For example, the pneumatic chamber 10200 may have a first wing (not shown) and a second wing 10220 extending therefrom, each wing adapted to couple to a respective arm 10326, 10328. For example, each wing can carry a portion of a fastener, such as a button, clip, or the like, adapted to mate with a corresponding portion on the respective arm 10326 or 10328 to secure the wing to the arm 10326, 10328. Alternatively, a hook-and-loop arrangement (such as a nanofiber-based hook-and-loop arrangement) can be used to attach the first and second wings to the arms 10326, 10328 in a manner similar to that described above with reference to the positioning and stabilizing structures 7300 and 9300. Additionally, the wings may carry spikes or similar structures that can be inserted into the arms 10326 and 10328 for attachment. If the wings are formed of a textile material, or have a textile outer layer, the arms 10326 and 10328 may carry spikes or similar structures on their outer or inner surfaces (facing the patient) to embed into the fibers of the textile material of the wings for attachment.

[0317] Wings 10220 can be formed from a variety of materials, such as fabrics, polymers, elastomers, or combinations thereof.

[0318] The first arm 10326 and the second arm 10328 can each vary in stiffness relative to the upper fabric portion 10310 and the rear section 10304 along at least a portion of their lengths. For example, each of the first arm 10326 and the second arm 10328 can be stiffer than the upper fabric portion 10310 and the rear section 10304 at least in their midsections. The arms 10326, 10328 can be formed using thermoset yarns to provide the desired stiffness and / or using one or more stiffeners disposed in or on the arms 10326, 10328. The respective ends of the arms 10326, 10328 connected to the wings 10220 can be relatively more resilient than the midsections so that, when connected to the wings, they provide the necessary tension to hold the seal-forming structure 10100 in place.

[0319] In some forms of the present technology, a humidity exchanger 10230 may be disposed within the pneumatic chamber 10200. The humidity exchanger 10230 is a passive component located in the flow path that absorbs moisture and heat from the exhaled airflow and transfers it to the incoming airflow. One benefit of including a humidity exchanger 10230 in the pneumatic chamber is that it can reduce or eliminate the need for active humidification (such as by a humidifier 5000). The humidity exchanger 10230 reduces the likelihood of dry mouth, which may be particularly important for patients who are prone to mouth breathing and may therefore suffer from discomfort. It should be understood that a similar humidity exchanger may be disposed in the pneumatic chamber of any other form of the technology described herein.

[0320] In one form of the present technology, Figure 9A and 9B As shown, the positioning and stabilizing structure 11300 of the patient interface 11000 can have a connection port 11600 integrated therein to facilitate connection from, for example, Figure 9A The positioning and stabilizing structure shown is used as a first position or non-therapeutic configuration for wearing the headband to be converted to a Figure 9B A second position or treatment (or pre-treatment) configuration is shown in which the positioning and stabilizing structure 11300 is connectable to an air circuit 4170 in communication with the pneumatic chamber 11200 via a connection port 11600 .

[0321] Many different forms of connection between the air circuit 4170 and the connection port 11600 are possible, so long as a substantially airtight seal is formed to substantially prevent pressure leakage during treatment. For example, the port 11600 can include a magnetic element 11610 located on its inner surface for connecting to a corresponding magnetic element on a connector located at one end of the air circuit 4170. In another example, the connector of the air circuit can be attached to the connection port 11600 by a snap fit (such as an annular snap fit or a cantilever snap fit, either of which can be rigid to rigid or rigid to elastic) or a friction fit.

[0322] like Figure 9A As shown, the positioning and stabilizing structure 11300 includes an upper fabric portion 11310 including an elastic circumferential band for fitting to a patient's head during use. A first lower fabric portion 11320 is movably (e.g., hingedly, articulatedly, pivotally, etc.) connected to (e.g., integral with) the upper fabric portion 11310 and extends from the upper fabric portion 11310. The positioning and stabilizing structure 11300 is used to apply a force to the seal-forming structure 11100, such as Figure 9B The seal-forming structure 11100 can be a nasal mask having a pneumatic chamber 11200. Other types of masks, such as full-face masks and oronasal masks, can also be used as part of the patient interface in conjunction with the positioning and stabilizing structure 11300.

[0323] In this example, the positioning and stabilising structure 11300 is formed as a strap having a front (anterior) section 11302 and a rear (posterior) section 11304, wherein the front section 11302 has a first bifurcated section (spanning between bifurcation points 11312, 11314) such that the first bifurcation forms a first portion of an upper fabric portion 11310 and the second bifurcation forms a first lower fabric portion 11320. Thus, the upper fabric portion 11310 forms a first strap or band that, in use, can be encircled around the patient's forehead, as shown. Figure 9A As shown, the first lower fabric portion 11320 forms a downwardly stretchable second strap or band to directly or indirectly engage with the seal-forming structure 11100 to provide a force to maintain the seal-forming structure 11100 in a therapeutically effective position on the patient's head.

[0324] In some forms of the present technology, the rear section 11304 may also include a bifurcated section including a first rear portion 11306 as a second portion of the upper fabric portion 11310 and a second rear portion 11308 as a second lower fabric portion, as shown in FIG. Figure 9B The bifurcation of the posterior section 11304 enables a greater degree of support because tension can be provided at spaced locations on or near the back of the patient's head or occipital bone, and also provides a greater degree of adjustability so that the patient can better position the positioning and stabilizing structure 11300 for greater comfort. It should be understood that any other form of the posterior section 6304, 7304, 9304, 10304 of the present technology disclosed herein may also be used with Figure 9B The rear section 11304 of the positioning and stabilizing structure 11300 is bifurcated in a similar manner.

[0325] In some forms, rear section 11304 may be similar to the previously described front or anterior sections (e.g., anterior section 6302). For example, rear section 11304 may comprise a width that combines the measured widths of first rear portion 11306 and second rear portion 11308. This combined width may be substantially similar to the combined width of first lower fabric portion 11320 and the first portion of upper fabric portion 11310 (e.g., which together form anterior section 11302).

[0326] Rear section 11304 can move between a first position and a second position. Similar to the above, when first rear portion 11306 and second rear portion 11308 are positioned close to each other, rear section 11304 can be in the first position. When first rear portion 11306 and second rear portion 11308 are spaced apart from each other, rear section 11304 can be in the second position.

[0327] In some forms (see e.g. Figure 9A ), the rear section 11304 can be in a first position when the first rear portion 11306 and the second rear portion 11308 are positioned in a lower portion of the patient's head (e.g., covering the occipital bone, near the bottom of the patient, etc.). Alternatively, the first rear portion 11306 and the second rear portion 11308 can be positioned slightly higher on the patient's head so that at least one covers the parietal bone.

[0328] In some forms (see e.g. Figure 9B ), the rear section 11304 can be in a second position when the first rear portion 11306 and the second rear portion 11308 are spaced apart from each other. When the entire positioning and stabilizing structure 11300 is in the second position, the front section 11304 and the rear section 11306 can combine to form an X-shape when viewed from the side of the patient's head.

[0329] In some forms, first posterior portion 11306 can be moved from a first position to a second position (e.g., above and overlying the parietal bone) relative to second posterior portion 11308. In other forms, second posterior portion 11308 can be moved from a first position to a second position (e.g., in an inferior direction) relative to first posterior portion 11306. In yet another form, both first posterior portion 11306 and second posterior portion 11308 can be moved away from each other relative to second posterior portion 11308 from a first position (e.g., above and overlying the parietal bone) to a second position.

[0330] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a strap that is flexible, i.e., non-rigid. An advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0331] In some forms of the present technology, the positioning and stabilizing structure includes a strap configured to be breathable to allow moisture vapor to be transferred through the strap.

[0332] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each positioning and stabilizing structure configured to provide retention corresponding to a different range of sizes and / or shapes. For example, the system may include one form of the positioning and stabilizing structure 3300 that is suitable for large heads but not for small heads, and another form that is suitable for small heads but not for large heads.

[0333] 5.3.3.1 Sensor and Actuator Arrangement for Patient Interface

[0334] In some forms of the present technology, a patient interface may have one or more sensors and / or actuators provided therein for measuring physiological and sleep data of the patient. The one or more sensors and the one or more actuators may be individually embedded within the patient interface, such as between fabric layers of a headband of the patient interface, or may be attached to the inner and / or outer surfaces of the headband or other components of the patient interface. For example, the one or more sensors and / or actuators may be integrated into a positioning and stabilizing structure, and / or into another component such as a seal-forming structure or a pneumatic chamber.

[0335] In some forms, the headband may include one or more leads, cables, or other conductive elements extending therefrom and electrically communicating with one or more sensors or actuators. Each such conductive element may include a terminal that can contact the skin of the headband wearer to provide one or more suitable signal grounding points on the wearer's face or head, such as behind the ears or below the eye sockets. This is useful for implementing an EEG, EMG, or EOG system within the headband.

[0336] Sensors embedded in the patient interface can help collect sleep-related data and physiological indicators, such as vital signs; this can be used to determine improvements in sleep and health by comparing data before and after treatment begins. This data can be processed and used to inform the patient how treatment can improve sleep. For example, a patient can wear a positioning and stabilizing structure 11300 with integrated sensors as a headband before starting treatment, such as Figure 9A As shown, physiological and sleep data can be recorded while the patient is asleep (and during the day in the case of physiological data). After treatment is initiated, the positioning and stabilizing structure 11300 is in Figure 9B In the treatment configuration shown, further physiological and sleep data can be recorded and compared with the data recorded before the treatment began. The physiological and sleep data can be transmitted to an external computing device, such as the patient's smartphone, and / or a monitoring server operated or accessible by a clinician or other health care provider.

[0337] Because the patient is able to wear the positioning and stabilizing structure 11300 as a headband and obtain data-based feedback about how the therapy is actually helping (e.g., via an app executed on the patient's smartphone), patient compliance is more likely, resulting in a smoother adaptation. The collected data can also be used to determine population-level sleep and / or physiological characteristics for one or more groups of patients undergoing respiratory therapy, thereby potentially enabling better customization of therapy for patients belonging to a particular category, or enabling optimization of the operation of the RPT device 4000.

[0338] In some forms of the present technology, measurement of patient-side functional parameters using sensors integrated into and / or attached to the mask can provide improved, active, feedback-based control of the RPT device 4000 to which the patient interface is connected, for example, improved feedback control of the pressure generator 4140 of the RPT device 4000 ( Figure 10B ).

[0339] For example, reference Figure 9B and 9C , the upper fabric portion 11310 of the positioning and stabilizing structure 11300 can have a plurality of electronic modules (actuators and / or sensors) 11354, 11356, 11358, and 11360 integrated therein. A processor module 11350 can also be integrated into the positioning and stabilizing structure 11300, typically also integrated into the upper fabric portion 11310, but it will be appreciated that the processor module 11350 can be located elsewhere within the positioning and stabilizing structure 11300. The processor module 11350 can have an integrated transceiver for sending and receiving data to and from an external computing device. A battery 11352 is also included to power the various electronic components of the positioning and stabilizing structure 11300 (sensors / actuators 11354-11360 and the processor module 11350).

[0340] like Figure 9C As shown, sensors and associated electronics can be at least partially integrated between the fabric layers of upper fabric portion 11310. For example, various sensor / actuator modules and / or associated circuitry, processor module 11350, and battery module 11352 can be located between an inner, patient-contacting fabric layer 11370 and an outer, non-patient-contacting fabric layer 11372.

[0341] For example, the sensor and / or actuator modules integrated into the positioning and stabilizing structure 11300 can be in electrical communication with the processor 11350 and the battery 11352 via a bus 11365. The bus 11365 can be disposed between two insulating layers 11366, which provide electrical insulation and also prevent the ingress of moisture, such as from perspiration absorbed by the inner fabric layer 11370. The insulating layer 11366 can be, for example, a non-conductive polymer or elastomeric film, but it will be appreciated that other electrically insulating materials can also be used.

[0342] In some forms of the present technology, a thermal insulation layer may be provided between at least some of the electronic components of the positioning and stabilizing structure 11300, noting that these components will tend to generate heat during use. Thus, the thermal insulation layer may help improve patient comfort. For example, the layer 11366 closest to the patient contacting inner layer 11370 may be both thermally and electrically insulating, or an additional thermal insulation layer may be interposed between the electrically insulating layer 11366 and the inner layer 11370. In some examples, the inner layer 11370 itself may be thermally insulating.

[0343] In some forms of the present technology, sensor and / or actuator modules 11354-11360 and their associated circuitry, as well as other modules including a processor 11350 and a battery 11352, may be housed within sensor retention structures 11380-11390 secured to an insulating layer 11366 and / or an inner fabric layer 11370. Each sensor retention structure 11380-11390, for example, is in electrical communication with a bus 11365 and may include electrical contacts to electrically connect the circuitry of the sensor module (or circuitry associated with the sensor module) to the bus 11365, and thus also to the battery 11352 and processor 11350. In some examples, communication between the modules 11350-11360 and the bus 11365 may be via conductive ink and / or conductive thread woven into or otherwise integrated with the fabric layers 11370 and / or 11372. In some embodiments, the electrical contacts and / or circuit traces may be contained only in the outer layer 11372 so as to not be affected by sweat from the patient during use.

[0344] In some examples, the modules 11350-11360 can be separated from the sensor holding structures 11380-11390 so that a particular module can be used for other modules with different functions or to replace modules that have stopped working or are at the end of their life cycle. For example, the modules 11350-11360 (and / or the circuit modules 11355, 11357, 11359 and 11361 to which they are electrically connected, if applicable) can be releasably attached to the sensor holding structures 11380-11390. To this end, the outer surface of the module can form a friction fit with the inner surface of the wall of the sensor holding structure 11380-11390, or can form a snap fit, such as an annular snap fit or a cantilever snap fit, with the wall or other internal or external portion of the sensor holding structure. In some embodiments, non-mechanical couplings, such as magnetic couplings, can be used to retain the modules 11350-11360 in the corresponding sensor holding structures 11380-11390.

[0345] In some forms of the present technology, the sensor retention structure 11380-11390 may include a pocket formed in the upper fabric portion 11310 (e.g., by forming a cutout in the outer layer 11372 or the inner layer 11370) into which the modules 11350-11360 (or their associated circuitry) may be inserted to electrically connect to the bus 11365.

[0346] The battery module 11352 may include a rechargeable battery. The battery can be recharged by connecting the battery to an external power source, such as via a micro USB or USB-C port of the battery module 11352 (e.g., a port exposed via the outer fabric layer 11372), or by inductive charging. In some embodiments, the battery 11352 may be a disposable battery, such as provided in a pocket 11382 of the upper fabric portion 11310, and can be removed by the patient to be replaced with a new battery.

[0347] In some forms of the present technology, one or more sensor modules and / or actuator modules may be completely encapsulated between the fabric layers 11370, 11372, such that no portion of the one or more sensor modules is exposed. For example, the actuator module 11360 may be coupled to associated circuitry 11361 housed in the sensor retention structure 11390. Both the actuator module 11360 and the circuitry 11361 are completely located between the fabric layers 11370, 11372. In another example, the sensor module 11356 and associated circuitry 11357 may be completely located between the fabric layers 11370, 11372. An example of a sensor module 11356 that may be completely embedded is an accelerometer or a gyroscope.

[0348] In some forms of the present technology, a sensor module or actuator module can be at least partially exposed. For example, a humidity sensor 11358 coupled to circuit 11359 can be at least partially exposed to the surrounding environment through outer fabric layer 11372 to measure the humidity of the patient's environment. To this end, outer fabric layer 11372 can include holes through which a surface of humidity sensor 11358 can be exposed. In another example, a sensor 11354 coupled to circuit 11355 can have a surface exposed through inner fabric layer 11370 (e.g., through holes formed therein) such that the sensor surface can contact the patient's skin when the positioning and stabilizing structure 11300 is worn by the patient. For example, sensor 11354 can be a pulse oximeter.

[0349] While the electronic components are described above as being modular in construction and, in at least some cases, capable of being switched out for other components, in some forms of the present technology, one or more electronic components (e.g., sensors or actuators) may be woven or otherwise integrated into the material of the upper fabric portion 11310, such as into the outer fabric layer 11372 or the inner fabric layer 11370, and / or into another portion of the positioning and stabilizing structure 11300, such as the lower fabric portion 11320, and / or one or both of the rear portions 11306, 11308. This may allow the sensors to be distributed over a larger area, allowing for more information and / or more accurate measurements.

[0350] In some forms of the present technology, the sensor may include a touch sensor, such as a capacitive or resistive sensor or a tactile switch, and may have associated circuitry that enables the sensor to function as a "pause" button. For example, the touch sensor may be incorporated into an exposed area of ​​the positioning and stabilizing structure 11300 or the seal-forming structure 11100. In one example, the touch sensor 11358 may be in the form of a Figure 9C 11359 can be positioned on upper fabric portion 11310 in the manner shown. Touch sensor 11358 can communicate with processor / transceiver 11350 as previously described, such that signals recorded by touch sensor 11358 and circuitry 11359 can be sent by processor / transceiver 11350 to an external device, such as pressure generator 4140 of RPT device 4000.

[0351] For example, if a patient has the patient interface 11000 in place and wishes to speak, or wakes up during the night and is uncomfortable due to the positive pressure in the pneumatic chamber 11200, the patient may activate the "pause" sensor 11358 with a light, continuous touch. The circuit 11359 may detect the touch and send a pause signal to the pressure generator 4140 (e.g., via the data communication interface 4280). Figure 10C) to immediately reduce the flow rate to a very low value (e.g., just enough to avoid the feeling of choking). When pause sensor 11358 is released (or reset or reactivated), this is detected by circuit 11359 and another signal is sent to pressure generator 4140 to cause the ramp-up algorithm implemented by RPT device 4000 to be reset.

[0352] Some forms of the present technology may include one or more sensors for determining a patient's sleeping position and movement before and / or during respiratory therapy. In some forms, the determined sleeping position and movement may be used to adjust the operation of the pressure generator 4140, and / or provide sensory stimulation to the patient to cause the patient to change position. For example, if one or more sensors detect that the number of apnea and / or hypopnea events exceeds a certain threshold, and / or blood oxygenation is reduced (regardless of whether the pressure generator 4140 is operable at this time), this may indicate back sleeping. One or more actuators may receive an activation signal based on this detection, and the activation signal may cause the one or more actuators to generate vibrations or other tactile stimulations to sufficiently stimulate the patient to cause them to switch to another sleeping position.

[0353] For example, the positioning and stabilizing structure 11300 or the seal-forming structure 11100 may include an accelerometer and / or a gyroscope. The accelerometer and / or gyroscope may be completely enclosed between the fabric layers 11370 and 11372 of the upper fabric portion 11310, for example, as shown in FIG. Figure 9C The accelerometer and gyroscope are both in communication with the processor / transceiver 11350 so that data recorded by them can be sent to the RPT device 4000 to adjust the operation of the pressure generator 4140.

[0354] The measurements recorded by the accelerometer can be used to determine the patient's sleeping position and adjust the treatment accordingly. When the patient is detected as supine, the pressure generator 4140 can slowly increase the treatment pressure to prevent sleep apnea events. When side sleeping is detected, the treatment pressure can be reduced. When an upright position is detected (e.g., pre-sleep reading, mask open), the flow and pressure can be just enough to avoid the feeling of suffocation.

[0355] Measurements recorded by the gyroscope can be used to determine patient movement and adjust treatment accordingly. When significant movement is detected, indicating the patient may be awake, treatment pressure can be kept low enough to avoid a feeling of suffocation. As movement subsides, treatment pressure can be raised very slowly to avoid discomfort.

[0356] In some forms of the present technology, accelerometer and / or gyroscope measurements can be used to determine the patient's sleep stage and turn the pressure generator 4140 on or off accordingly. For example, if treatment is started while the patient is still awake, the patient may have difficulty falling asleep. Therefore, if the accelerometer and / or gyroscope measurements indicate an awake or light sleep stage, the pressure generator 4140 can remain in an "off" or paused state, and once the measurements indicate that the patient is in a deep sleep stage, the pressure generator 4140 is turned on (typically, with a gentle ramp-up). Conversely, for example, if treatment has begun and it is detected that the patient has switched from deep sleep to light sleep, where the treatment may cause the patient to breathe, the pressure generator 4140 can be paused until the patient is again in deep sleep.

[0357] In some forms of the present technology, a pulse oximeter incorporated into the positioning and stabilizing structure 11300 may be used to assess sleep health. For example, Figure 9C As shown, a pulse oximeter 11354 and associated circuitry 11355 can be incorporated into the upper fabric portion 11310 of the positioning and stabilizing structure 11300. The pulse oximeter 11354 is exposed through a hole in the inner fabric layer 11370 so that it can contact the skin on the patient's forehead. The measurements recorded by the pulse oximeter 11354 can be used to determine blood oxygen saturation levels and heart rate while the patient interface 11000 is worn, and this data can be transmitted to the RPT device 4000 or an external computing device, such as a smartphone, other mobile computing device, or the patient's laptop or desktop computing system. Time series data can be used to provide feedback to the patient regarding their health level and recommendations for follow-up (e.g., by a clinician).

[0358] In one example, an apnea-hypopnea index (AHI), a metric used by clinicians to categorize the severity of sleep apnea, can be determined based on sensor measurements. The AHI calculation can use a combination of data from different sensors, such as blood oxygen levels and heart rate (e.g., measured by a PPG sensor), as well as chest movement (e.g., measured by an accelerometer and / or gyroscope). The AHI value can be used to determine when an "apnea" occurs.

[0359] Thus, by tracking the AHI over time, clinicians will be able to tell whether a patient has sleep apnea and provide details on its severity. Furthermore, by analyzing the AHI data along with other sensor data, clinicians will not only be able to correlate the frequency of apneas with a specific sleeping position (e.g., supine or side sleeping), but will also be able to tailor CPAP therapy to the patient's specific needs. For example, the amount of mouth breathing can be detected using a temperature and / or humidity sensor located within the pneumatic chamber of the patient interface and a corresponding prescribed nasal or full-face mask. Additionally, a pressure generator 4140 setting that will produce the flow rate that best suits the patient can be recommended based on the sensor measurements. For example, for a patient with a high rate of detected apnea or hypopnea events, a clinician can prescribe a higher pressure setting (or equivalently, a higher flow rate). The prescribed flow rate can also depend on the patient's anatomy, such as if the patient has a more collapsible upper airway.

[0360] In some forms of the present technology, EEG sensors may be disposed in the positioning and stabilizing structure 11300, such as in the upper fabric portion 11310. The EEG sensors may be disposed in a manner similar to that described in the preceding text. Figure 9C 1354 is partially exposed in a manner shown in FIG136 so that it can contact the skin of the patient's forehead. Typically, the EEG sensor includes multiple EEG electrodes that generate signals that can be analyzed to detect sleep stages. The signals can be sent (via transceiver 11350) to an external device, such as the patient's smartphone, and the sleep stage, cycle, and duration information can be used to provide the patient with feedback on how well sleep therapy is proceeding, as well as suggestions for enhancing health. For example, EEG sensor measurements can be used for accurate sleep staging to enable more accurate determination of when apnea or sleep arousal occurs, such as during a sleep study.

[0361] In some forms of the present technology, sleep stage information may be communicated to the RPT device 4000 so that the pressure generator 4140 may use the sleep stage information to adjust the therapy pressure to avoid arousal or occlusion events.

[0362] In some forms of the present technology, sleep stage information can be used to activate sleep-enhancing white / pink noise and / or binaural beats. These can be generated by an audio device embedded in the patient interface 11000 itself, or by an external device that receives a trigger signal from the patient interface 11000 via the transceiver 11350. For example, one or more miniature bone conduction speakers can be incorporated into the temple area of ​​the upper fabric portion 11310.

[0363] In some forms of the present technology, the positioning and stabilizing structure 11300 may incorporate electromyography (EMG) and / or electrooculography (EOG) sensors. The EMG and EOG sensor signals may be analyzed to determine the onset of REM sleep stages. In a manner similar to the example incorporating EEG sensors, the sleep stage information determined by the EMG / EOG sensors may be used to provide feedback to the patient regarding how well sleep therapy is progressing, and may also be used to adjust the pressure generator 4140 to avoid arousal or obstruction events, or to activate one or more audio devices to generate sleep-enhancing noises.

[0364] At least some of the EMG / EOG sensors can be incorporated into the upper fabric portion 11310. For example, a ground electrode and a reference electrode can be disposed in the upper fabric portion 11310, such as at the front thereof, and exposed through corresponding holes in the inner layer 11370 so as to contact the patient's forehead. In another example, the ground electrode can be disposed in the rear portion 11306 of the upper fabric portion 11310, or in the second lower fabric portion 11308, such that the ground electrode is positioned behind the patient's ear during use. Additional electrodes can be provided, each having a cable attached at one end to the upper fabric portion 11310, the first lower fabric portion 11320, or the second lower fabric portion 11308, and at the other end to an electrode patch that the patient can position on their temple and under their eye to provide two additional measurement channels.

[0365] In some forms of the present technology, a microphone, such as a MEMS microphone or an electret microphone, can be incorporated into the patient interface 11000 to detect snoring. For example, the microphone can be located in or on the inner surface of the pneumatic chamber 11200, or on its outer surface, adjacent to the patient's nostrils. The microphone can be coupled to a communication interface to enable data to be transmitted to the pressure generator 4140 of the RPT device 4000 to adjust the pressure generated thereby. For example, when a light snoring noise pattern is detected, the treatment pressure can be gradually increased to prevent an obstruction event. When the snoring noise pattern subsides, the treatment pressure can be decreased.

[0366] In some forms of the present technology, the patient interface 11000 can include a humidity sensor and a temperature sensor, for example on an inner surface of the pneumatic chamber 11200, to monitor the temperature and humidity within the pneumatic chamber 11200. The sensors can be coupled to a communication interface for transmitting humidity and temperature data to the RPT device 4000 and the humidifier 5000 to adjust their operation. The power to the pressure generator 4140 and the humidifier 5000 can be adjusted to prevent condensation from accumulating. For example, the humidifier 5000 can be activated in stages, and / or the heater power level can be controlled, followed by a flush with normal air, still maintaining a sufficient humidity level (measured by the humidity sensor) to prevent dryness of the mouth.

[0367] In some forms of the present technology, a pressure sensor may be disposed within the pneumatic chamber 11200, such as on its inner surface. This allows the air pressure within the pneumatic chamber 11200 to be measured and sends a signal to the pressure generator 4140 to dynamically adjust the pressure and flow. This can optimize the response of the pressure generator 4140 to the patient's breathing pattern.

[0368] In some forms of the present technology, a CO2 sensor may be provided within the pneumatic chamber 11200. For example, the CO2 level within the pneumatic chamber 11200 may be monitored. When a slight increase in the CO2 level is detected, the electromechanical vent ( Figures 9A-9C ) to allow for a higher flush of air from the pneumatic chamber 11200. Additionally, a signal can be sent to the pressure generator 4140 to slightly increase the flow of flush CO2 when the CO2 level increases slightly. This can be done dynamically to minimize patient discomfort.

[0369] In some forms of the present technology, a combination of sensors and actuators may be provided to achieve localized temperature changes to improve patient comfort. For example, an EEG sensor and / or a pulse oximeter may be provided in the upper fabric portion 11310 (e.g., in the form of a Figure 9C 11354 in the embodiment), and the temperature sensor and / or humidity sensor may also be provided in the upper fabric portion 11310 (e.g., in the embodiment shown in FIG. Figure 9C Signals from the EEG and / or PPG sensors can be analyzed to detect sleep states, and signals from the temperature sensor and / or humidity sensor can be used to assess environmental comfort levels. One or more Peltier elements can be provided, for example in the form of a wearable wristband, and can be coupled to circuitry that communicates with the EEG / PPG and temperature / humidity sensors to receive signals indicating sleep states and environmental comfort levels, and to activate the Peltier elements to locally heat or cool the body (e.g., at the wrist) to help the patient maintain a comfortable sleep state.

[0370] In some forms of the present technology, tactile feedback elements (such as micro-vibrating motors) can be incorporated into the patient interface 11000, for example, in the temple area of ​​the positioning and stabilizing structure 11300 (e.g., the upper fabric portion 11310). The tactile feedback element can deliver vibrations to the patient to produce a calming effect. For example, the processor 11350 can monitor heart rate data from the pulse oximeter 11354 and, if the heart rate data exceeds a threshold, send a trigger signal to the tactile feedback element to cause the tactile feedback element to vibrate at a few beats lower than the patient's current heart rate, thereby helping to slow the heart rate. In another example, as described above, if the patient is detected to be in a sleeping position associated with an apnea or hypopnea event, the tactile feedback element can be used to influence the patient's sleeping position.

[0371] In some forms of the present technology, one or more micro-thermoelectric generators (TEGs) may be incorporated into the patient interface 11000 so that the difference between the patient's body temperature and the ambient temperature can be used to generate a potential difference and thereby provide power to the various electronic components (sensors, actuators, processors, etc.) of the patient interface 11000. For example, the micro-TEGs may be located in the upper fabric portion 11310 and exposed through holes in the inner layer 11370 so that they contact the patient's forehead.

[0372] In some forms of this technology, multiple sensors can be combined into a single module. For example, an accelerometer and a gyroscope can be combined into a single package.

[0373] Although various sensors and actuators have been described as being incorporated into Figures 9A-9C The patient interfaces 11000 are shown, but it will be appreciated that they may be incorporated in a similar manner into any other patient interface 3000, 6000, 7000, 8000, 9000, 10000 disclosed herein.

[0374] 5.3.4 Ventilation

[0375] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide.

[0376] In certain forms, the vents 3400, 10400 are configured to allow continuous ventilation flow from the interior of the pneumatic chamber 3200 to the ambient environment while the pressure within the pneumatic chamber is positive relative to the ambient environment. The vents 3400 are configured such that the vent flow rate has a sufficient amplitude to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure in the pneumatic chamber during use.

[0377] One form of a vent 3400, 10400 in accordance with the present technology includes a plurality of holes, for example, from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0378] The vent 3400, 10400 may be located in the pneumatic chamber 3200, 10200. Alternatively, the vent 3400, 10400 is located in a decoupling structure (eg, a rotary joint).

[0379] In some versions, vent 10400 may be a transparent mesh with built-in vents.

[0380] Despite Figures 4B-4D , 5A-5B, 6, 7A-7C and 8B are not explicitly shown, but it should be understood that the pneumatic chamber of each example shown in these figures typically also includes a vent that can flush CO2 and other exhaled gases.

[0381] In some forms of the present technology, the vents 3400, 10400 may be active vents and may be activated based on sensor measurements from one or more sensors of a patient interface, such as patient interface 10000. For example, in some forms, the pneumatic chamber 10200 may include one or more of a CO2 sensor, a temperature sensor, and a humidity sensor, and detection of one or more of these quantities above corresponding thresholds may trigger opening of the vent.

[0382] 5.3.5 Decoupling Structure

[0383] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0384] 5.3.6 Connection Port

[0385] Connection ports 3600, 6600, 7600, 8600, 9600, 10600, 11600 allow connection to air circuit 4170. In some examples, connection port 11600 can be integrated with positioning and stabilizing structure 11300, such as Figure 9A shown.

[0386] A variety of different connections are possible between the air circuit 4170 and the connection ports 3600, 6600, 7600, 8600, 9600, 10600, and 11600, so long as a substantially airtight seal is formed to substantially prevent pressure leakage during treatment. As described with respect to port 11600, a magnetic element can be located on the inner surface of the connection port for connecting to a corresponding magnetic element on a connector located at one end of the air circuit 4170. In another example, the connector of the air circuit can be attached to the connection port by a snap fit (such as an annular snap fit or a cantilever snap fit, either of which can be rigid to rigid or rigid to elastic) or a friction fit.

[0387] 5.3.7 Forehead support

[0388] In one form, the patient interface 3000 includes a forehead support 3700 .

[0389] 5.3.8 Anti-suffocation valve

[0390] In one form, patient interface 3000 includes an anti-asphyxia valve.

[0391] 5.3.9 Port

[0392] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the pneumatic chamber 3200. In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows for direct measurement of properties of the gas within the pneumatic chamber 3200, such as pressure.

[0393] 5.4RPT device

[0394] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300, such as all or part of any of the methods described herein. The RPT device 4000 can be configured to generate an air flow for delivery to a patient's airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0395] In one form, the RPT device 4000 is constructed and arranged to deliver air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0396] The RPT device 4000 can have an outer housing 4010 comprised of two parts: an upper portion 4012 and a lower portion 4014. Furthermore, the outer housing 4010 can include one or more panels 4015. The RPT device 4000 can include a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 can include a handle 4018.

[0397] The pneumatic path of the RPT device 4000 can include one or more air path items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 capable of supplying positive pressure air (e.g., a blower 4142), an outlet muffler 4124, and one or more converters 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0398] One or more air path items may be disposed within a removable, separate structure, which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by, or forms part of, the chassis 4016.

[0399] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a converter 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 alternative forms, the RPT device 4000 may include more than one PCBA 4202.

[0400] 5.4.1 Mechanical and pneumatic components of the RPT device

[0401] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be provided as separate units.

[0402] 5.4.1.1 Air filter

[0403] An RPT device according to one form of the present technology may include an air filter 4110, or multiple air filters 4110.

[0404] In one form, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140 .

[0405] In one form, an outlet air filter 4114 , such as an antimicrobial filter, is disposed between the pneumatic block 4020 and the patient interface 3000 .

[0406] 5.4.1.2 Silencer

[0407] An RPT device according to one form of the present technology may include a silencer 4120 or a plurality of silencers 4120 .

[0408] In one form of the present technology, an inlet muffler 4122 is disposed in the pneumatic path upstream of the pressure generator 4140 .

[0409] In one form of the present technology, an outlet muffler 4124 is disposed in the pneumatic path between the pressure generator 4140 and the patient interface 3000 .

[0410] 5.4.1.3 Pressure generator

[0411] In one form of the present technology, the pressure generator 4140 for generating a positive pressure air flow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. When delivering respiratory pressure therapy, the blower can deliver the air supply, for example, at a rate of up to about 120 liters per minute, at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower can be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. 2013 / 020167.

[0412] The pressure generator 4140 may be under the control of the treatment device controller 4240 .

[0413] 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.

[0414] 5.4.1.4 Converter

[0415] The transducer may be internal to the RPT device or external to the RPT device. An external transducer may be disposed on or form part of, for example, an air circuit such as 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.

[0416] In one form of the present technology, one or more transducers 4270 are positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be configured and arranged to generate a signal representative of a characteristic of the airflow, such as flow rate, pressure, or temperature, at that point in the pneumatic path.

[0417] In one form of the present technology, one or more transducers 4270 may be positioned adjacent to the patient interface 3000 .

[0418] In one form, the signal from converter 4270 may be filtered, such as by low pass filtering, high pass filtering, or band pass filtering.

[0419] 5.4.1.4.1 Flow sensor

[0420] A flow sensor 4274 according to the present technology may be based on a differential pressure transducer, such as the SDP600 series differential pressure transducers from SENSIRION.

[0421] In one form, a signal generated by the flow sensor 4274 and representative of the flow rate is received by the central controller 4230.

[0422] 5.4.1.4.2 Pressure sensor

[0423] A pressure sensor 4272 according to the present technology is positioned in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a transducer from the ASDX series from HONEYWELL. An alternative suitable pressure sensor is a transducer from the NPA series from GENERALELECTRIC.

[0424] In one form, a signal generated by the pressure sensor 4272 and representing pressure is received by the central controller 4230.

[0425] 5.4.1.4.3 Motor Speed ​​Converter

[0426] In one form of the present technology, a motor speed converter 4276 is used to determine the rotational speed of the motor 4144 and / or blower 4142. A motor speed signal from the motor speed converter 4276 may be provided to the treatment device controller 4240. The motor speed converter 4276 may be, for example, a speed sensor such as a Hall effect sensor.

[0427] 5.4.1.5 Anti-overflow valve

[0428] In one form of the present technology, an anti-spill back valve 4160 is provided between the humidifier 5000 and the pneumatic block 4020. The anti-spill back valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0429] 5.4.2 RPT device electrical components

[0430] 5.4.2.1 Power supply

[0431] The power source 4210 may be disposed inside or outside the outer housing 4010 of the RPT device 4000 .

[0432] In one form of the present technology, the power supply 4210 provides power only to the RPT device 4000. In another form of the present technology, the power supply 4210 provides power to both the RPT device 4000 and the humidifier 5000.

[0433] 5.4.2.2 Input device

[0434] In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow a person to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessed via a touch screen. In one form, the buttons, switches, or dials may be physically connected to the external housing 4010, or in another form, the buttons, switches, or dials may be in wireless communication with a receiver that is electrically connected to a central controller 4230.

[0435] In one form, input device 4220 may be constructed or arranged to allow a person to select values ​​and / or menu options.

[0436] 5.4.2.3 Central Controller

[0437] In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0438] Suitable processors may include x86 Intel processors, processors based on processors from ARM Holdings, In certain alternative forms of the present technology, a 32-bit RISC CPU such as the STR9 series of microcontrollers from STMicroelectronics, or a 16-bit RISC CPU such as the MSP430 series of microcontrollers from Texas Instruments may also be suitable.

[0439] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0440] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0441] The central controller 4230 may be configured to receive input signals from one or more transducers 4270 , one or more input devices 4220 , and the humidifier 5000 .

[0442] The central controller 4230 may be configured to provide output signals to one or more output devices 4290 , the therapy device controller 4240 , the data communication interface 4280 , and the humidifier 5000 .

[0443] In some forms of the present technology, the central controller 4230 is configured to implement one or more of the methods described herein, such as one or more algorithms 4300 that may be implemented using processor control instructions represented as a computer program stored in a non-transitory computer-readable storage medium such as memory 4260. In some forms of the present technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of the present technology, some of the methods may be performed by a remotely located device. For example, the remotely located device may determine ventilator control settings or detect respiratory-related events by analyzing stored data, such as from any of the sensors described herein.

[0444] 5.4.2.4 Clock

[0445] The RPT device 4000 may include a clock 4232 connected to a central controller 4230 .

[0446] 5.4.2.5 Treatment device controller

[0447] In one form of the present technology, the treatment device controller 4240 is a treatment control module 4330 that forms part of the algorithm 4300 executed by the central controller 4230.

[0448] In one form of the present technology, the treatment device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, the MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0449] 5.4.2.6 Protection circuit

[0450] One or more protection circuits 4250 in accordance with the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0451] 5.4.2.7 Memory

[0452] According to one form of the present technology, the RPT device 4000 includes memory 4260, such as non-volatile memory. In some forms, the memory 4260 may include battery-backed static RAM. In some forms, the memory 4260 may include volatile RAM.

[0453] Memory 4260 may be located on PCBA 4202. Memory 4260 may be in the form of EEPROM or NAND flash memory.

[0454] Additionally or alternatively, the RPT device 4000 includes memory 4260 in a removable form, such as a memory card made in accordance with the Secure Digital (SD) standard.

[0455] In one form of the present technology, the memory 4260 serves as a non-transitory computer-readable storage medium on which are stored computer program instructions representing one or more methods described herein, such as one or more algorithms 4300 .

[0456] 5.4.2.8 Data Communication System

[0457] In one form of the present technology, a data communication interface 4280 is provided and connected to the central controller 4230. The data communication interface 4280 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.

[0458] In one form, the data communication interface 4280 is part of the central controller 4230. In another form, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.

[0459] In one form, remote external communication network 4282 is the Internet. Data communication interface 4280 may connect to the Internet using wired communication (eg, via Ethernet or fiber optic) or wireless protocols (eg, CDMA, GSM, LTE).

[0460] In one form, the local external communication network 4284 utilizes one or more communication standards, such as Bluetooth or consumer infrared protocols.

[0461] In one form, the remote external device 4286 can be one or more computers, such as a cluster of network computers. In another form, the remote external device 4286 can be a virtual computer rather than a physical computer. In either case, the remote external device 4286 can be accessed by appropriately authorized personnel (such as a clinician).

[0462] The local external device 4288 may be a personal computer, a mobile phone, a tablet, or a remote control device.

[0463] 5.4.2.9 Output devices including optional displays and alarms

[0464] Output devices 4290 according to the present technology may take the form of one or more of visual, audio, and tactile units.The visual display may be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0465] 5.4.2.9.1 Display Driver

[0466] The display driver 4292 receives as input characters, symbols, or images for display on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols, or images.

[0467] 5.4.2.9 Display

[0468] The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an eight-segment display, in which case the display driver 4292 converts each character or symbol (such as the number "0") into eight logic signals indicating whether the eight corresponding segments are to be activated to display the particular character or symbol.

[0469] 5.4.3RPT device algorithm

[0470] As described above, in some forms of the present technology, central controller 4230 may be configured to implement one or more algorithms 4300 represented as computer programs stored in a non-transitory computer-readable storage medium such as memory 4260. Algorithms 4300 are generally grouped into groups called modules.

[0471] In other forms of the present technology, some or all of the algorithm 4300 may be implemented by a controller of an external device, such as a local external device 4288 or a remote external device 4286. In this form, data representing input signals and / or intermediate algorithm outputs required for the portion of the algorithm 4300 executed at the external device may be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In this form, the portion of the algorithm 4300 to be executed at the external device may be represented as a computer program stored in a non-transitory computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute that portion of the algorithm 4300.

[0472] In such forms, treatment parameters generated by the external device via the treatment engine module 4320 (if so forming part of the algorithm 4300 executed by the external device) may be transmitted to the central controller 4230 to be passed to the treatment control module 4330 .

[0473] 5.4.3.1 Preprocessing Module

[0474] A pre-processing module 4310 in accordance with one form of the present technology receives as input a signal from a transducer 4270 (e.g., a flow sensor 4274 or a pressure sensor 4272) and performs one or more processing steps to calculate one or more output values ​​to be used as input to another module (e.g., a therapy engine module 4320).

[0475] In one form of the present technology, the output values ​​include port pressure Pm, ventilation flow Qv, respiratory flow Qr, and leak flow Ql.

[0476] In various forms of the present technology, the pre-processing module 4310 includes one or more of the following algorithms: interface pressure estimation 4312 , ventilation flow estimation 4314 , leak flow estimation 4316 , and respiratory flow estimation 4318 .

[0477] 5.4.3.1.1 Interface pressure estimation

[0478] In one form of the present technology, an interface pressure estimation algorithm 4312 receives as input a signal from pressure sensor 4272 (device pressure Pd) and a signal from flow sensor 4274 representing the flow rate of airflow exiting the RPT device 4000 (device flow Qd). In the absence of any supplemental gas 4180, the device flow Qd can be used as the total flow Qt. The interface pressure estimation algorithm 4312 estimates the pressure drop P across the air circuit 4170. The dependence of the pressure drop P on the total flow Qt can be modeled for a particular air circuit 4170 by a pressure drop characteristic P(Q). The interface pressure estimation algorithm 4312 then provides as output an estimated pressure Pm in the patient interface 3000. The pressure Pm in the patient interface 3000 can be estimated as the device pressure Pd minus the air circuit pressure drop P.

[0479] 5.4.3.1.2 Ventilation Flow Estimation

[0480] In one form of the present technology, a vent flow estimation algorithm 4314 receives as input the estimated pressure Pm in the patient interface 3000 from the interface pressure estimation algorithm 4312 and estimates the vent flow rate Qv of air from the vent 3400 in the patient interface 3000. For the particular vent 3400 in use, the dependence of the vent flow rate Qv on the interface pressure Pm can be modeled by a vent characteristic Qv(Pm).

[0481] 5.4.3.1.3 Leakage flow estimation

[0482] In one form of the present technology, a leak flow estimation algorithm 4316 receives as input the total flow Qt and the ventilation flow Qv and provides as output an estimate of the leak flow Ql. In one form, the leak flow estimation algorithm estimates the leak flow Ql by averaging the difference between the total flow Qt and the ventilation flow Qv over a sufficiently long period of time (e.g., approximately 10 seconds).

[0483] In one form, the leak flow estimation algorithm 4316 receives as input the total flow Qt, ventilation flow Qv, and estimated pressure Pm in the patient interface 3000 and provides as output a leak flow Q1 by calculating a leak conductance and determining the leak flow Q1 as a function of the leak conductance and pressure Pm. The leak conductance is calculated as the quotient of the low-pass filtered non-ventilation flow, which is equal to the difference between the total flow Qt and ventilation flow Qv, and the low-pass filtered square root of the pressure Pm, where the low-pass filter time constant has a value long enough to encompass several respiratory cycles, for example, approximately 10 seconds. The leak flow Q1 can be estimated as the product of the leak conductance and the function of the pressure Pm.

[0484] 5.4.3.1.4 Respiratory flow estimation

[0485] In one form of the present technology, a respiratory flow estimation algorithm 4318 receives as input the total flow Qt, ventilation flow Qv, and leak flow Ql and estimates the respiratory flow Qr of air to the patient by subtracting the ventilation flow Qv and leak flow Ql from the total flow Qt.

[0486] 5.4.3.2 Treatment Engine Module

[0487] In one form of the present technology, therapy engine module 4320 receives as input one or more of pressure Pm in patient interface 3000 and respiratory flow Qr of air to the patient, and provides as output one or more therapy parameters.

[0488] In one form of the present technology, the treatment parameter is treatment pressure Pt.

[0489] In one form of the present technology, the therapy parameter is one or more of pressure amplitude, basal pressure, and target ventilation.

[0490] In various forms, the therapy engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow limitation determination 4324, apnea / hypopnea determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and therapy parameter determination 4329.

[0491] 5.4.3.2.1 Phase determination

[0492] In one form of the present technology, the RPT device 4000 is phase-indeterminate.

[0493] In one form of the present technology, phase determination algorithm 4321 receives as input a signal indicative of respiratory flow Qr and provides as output the phase Φ of the current respiratory cycle of patient 1000 .

[0494] In some forms, the phase output Φ is a discrete variable, referred to as discrete phase determination. One implementation of discrete phase determination provides a binary phase output Φ having inspiratory or expiratory values, e.g., values ​​of 0 and 0.5 revolutions, respectively, upon detecting the onset of spontaneous inspiration and expiration, respectively. A "triggered" and "cycled" RPT device 4000 effectively performs discrete phase determination because the trigger point and the cycle point are the moments when the phase changes from expiration to inspiration and from inspiration to expiration, respectively. In one implementation of binary phase determination, when respiratory flow Qr has a value exceeding a positive threshold, the phase output Φ is determined to have a discrete value of 0 (thereby "triggering" the RPT device 4000), and when respiratory flow Qr has a value more negative than a negative threshold, the phase output Φ is determined to have a discrete value of 0.5 revolutions (thereby "cycling" the RPT device 4000). The inspiratory time Ti and the expiratory time Te can be estimated as typical values ​​over a plurality of respiratory cycles for which the phase Φ is equal to 0 (indicating inspiration) and 0.5 (indicating expiration), respectively.

[0495] Another implementation of discrete phase determination provides a three-valued phase output Φ having a value of one of inspiration, mid-inspiratory pause, and expiration.

[0496] In other forms, referred to as continuous phase determination, the phase output Φ is a continuous variable, for example, varying from 0 to 1 revolution, or 0 to 2 radians. An RPT device 4000 performing continuous phase determination may trigger and cycle when the continuous phase reaches 0 and 0.5 revolutions, respectively. In one implementation of continuous phase determination, a fuzzy logic analysis of the respiratory flow Qr is used to determine continuous values ​​of the phase Φ. The continuous values ​​of the phase determined in this implementation are generally referred to as "fuzzy phase." In one implementation of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow Qr:

[0497] 1. If the respiratory flow is zero and increases rapidly, the phase is 0 revolutions.

[0498] 2. If respiratory flow is positive and stable, the phase is 0.25 turns.

[0499] 3. If the respiratory flow is zero and decreases rapidly, the phase is 0.5 turns.

[0500] 4. If the respiratory flow is large and stable, the phase is 0.75 turns.

[0501] 5. If the respiratory flow is zero and stable, and the absolute value of the 5-second low-pass filter of the respiratory flow is large, the phase is 0.9 turns.

[0502] 6. If the respiratory flow is positive and the phase is exhalation, the phase is 0 turns.

[0503] 7. If the respiratory flow is negative and the phase is inspiration, the phase is 0.5 turns.

[0504] 8. If the absolute value of the 5-second low-pass filtered respiratory flow is large, the phase increases at a steady rate equal to the patient's respiratory rate, low-pass filtered with a time constant of 20 seconds.

[0505] The output of each rule can be represented as a vector, whose phase is the result of the rule and whose magnitude is the degree of ambiguity regarding whether the rule is true. Appropriate membership functions are used to determine the degree of ambiguity regarding respiratory flow being "large," "stable," and so on. The results of the rules are represented as vectors and then combined using a function such as centroids. In such combinations, rules can be weighted equally or unequally.

[0506] In another implementation of continuous phase determination, the phase Φ is first discretely estimated from the respiratory flow Qr as described above, as are the inhalation time Ti and the exhalation time Te. The continuous phase Φ at any instant can be determined as half the fraction of the inhalation time Ti that has elapsed since the previous trigger instant, or as 0.5 revolutions plus half the fraction of the exhalation time Te that has elapsed since the previous cycle instant (whichever is more recent).

[0507] 5.4.3.2.2 Waveform determination

[0508] In one form of the present technology, the therapy parameter determination algorithm 4329 provides an approximately constant therapy pressure throughout the patient's breathing cycle.

[0509] In other forms of the present technology, the therapy control module 4330 controls the pressure generator 4140 to provide a therapy pressure Pt that varies as a function of the phase Φ of the patient's respiratory cycle according to a waveform template Π(Φ).

[0510] In one form of the present technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ) with values ​​in the range [0, 1] over the domain of phase values ​​Φ provided by the phase determination algorithm 4321 for use by the treatment parameter determination algorithm 4329.

[0511] In one form applicable to discrete or continuous phases, the waveform template Π(Φ) is a square wave template having a value of 1 for phase values ​​up to and including 0.5 revolutions and a value of 0 for phase values ​​greater than 0.5 revolutions. In one form applicable to continuous-valued phases, the waveform template Π(Φ) includes two smoothly curved portions, i.e., a smooth curve (e.g., raised cosine) rising from 0 to 1 for phase values ​​up to 0.5 revolutions and a smooth curve (e.g., exponential) decaying from 1 to 0 for phase values ​​greater than 0.5 revolutions. In one form applicable to continuous phases, the waveform template Π(Φ) is based on a square wave, but smoothly rises from 0 to 1 for phase values ​​up to a "rise time" of less than 0.5 revolutions, and smoothly falls from 1 to 0 for phase values ​​after 0.5 revolutions for a "fall time" less than 0.5 revolutions.

[0512] In some forms of the present technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a library of waveform templates based on the settings of the RPT device. Each waveform template Π(Φ) in the library can be provided as a lookup table of values ​​Π relative to phase values ​​Φ. In other forms, the waveform determination algorithm 4322 calculates the waveform template Π(Φ) "on the fly" using a predetermined functional form that may be parameterized by one or more parameters (e.g., the time constant of the exponential curvature). The parameters of the functional form may be predetermined or dependent on the current state of the patient 1000.

[0513] In some forms of the present technology, the waveform determination algorithm 4322 calculates the waveform template Π(Φ, t) "on the fly" based on the discrete phase Φ and time t measured since the most recent trigger moment, for a discrete two-valued phase for either inhalation (Φ = 0 revolutions) or exhalation (Φ = 0.5 revolutions). In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ, t) in both parts (inhalation and exhalation) as follows:

[0514]

[0515] where π i (t) and Π e (t) is the inspiratory and expiratory portion of the waveform template Π(Φ,t). In one such form, the inspiratory portion of the waveform template Π i (t) is a smooth rise from 0 to 1 parameterized by the rise time, while the exhalation part of the waveform template Π e (t) is a smooth decrease from 1 to 0 parameterized by the decrease time.

[0516] 5.4.3.2.3 Ventilation measurement

[0517] In one form of the present technology, a ventilation determination algorithm 4323 receives an input of respiratory flow Qr and determines a metric indicative of the current patient ventilation Vent.

[0518] In some implementations, the ventilation determination algorithm 4323 determines a measure of ventilation Vent as an estimate of actual patient ventilation. One such implementation is to take half the absolute value of the respiratory flow Qr filtered with a second-order Bessel low-pass filter having a corner frequency of 0.11 Hz.

[0519] In other implementations, the ventilation determination algorithm 4323 determines a measure of ventilation Vent that is approximately proportional to the actual patient ventilation. One such implementation estimates the peak respiratory flow Qpeak over the inspiratory portion of the cycle. If the flow waveform shape does not vary much (here, two breaths are considered similar in shape when the flow waveforms normalized in time and amplitude are similar), then many other processes related to respiratory flow Qr produce measures that are approximately proportional to ventilation. Some simple examples include the median of positive respiratory flow, the median of the absolute values ​​of respiratory flow, and the standard deviation of flow. Any linear combination of statistics of any order of absolute values ​​of respiratory flow using positive coefficients, and even some linear combinations of statistics of any order using positive and negative coefficients, are approximately proportional to ventilation. Another example is the average of K proportions (by time) of respiratory flow during the inspiratory portion, where 0 < K < 1. If the flow shape is constant, then there are arbitrarily many measurements that are exactly proportional to ventilation.

[0520] 5.4.3.2.4 Determining Inspiratory Flow Limitation

[0521] In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 for determining the degree of inspiratory flow limitation.

[0522] In one form, the inspiratory flow limitation determination algorithm 4324 receives as input the respiratory flow signal Qr and provides as output a measure of the extent to which the inspiratory portion of the breath exhibits inspiratory flow limitation.

[0523] In one form of the present technology, the inspiratory portion of each breath is identified by a zero crossing detector. A plurality of evenly spaced points (e.g., 65) representing time points are interpolated along the inspiratory flow-time curve for each breath by an interpolator. The curve described by the points is then scaled by a scalar to have uniform length (duration / cycle) and uniform area to eliminate the effects of changing breathing rate and depth. The scaled breath is then compared in a comparator to a pre-stored template representing a normal, unobstructed breath, similar to Figure 6 The inspiratory portion of the breath shown in A. At any time during inspiration from this template, breaths that deviate by more than a specified threshold (typically 1 scaled unit) are rejected, such as those due to coughing, sighing, swallowing, and hiccups as determined by the test element. For non-rejected data, a moving average of the first such scaled point of the first few inspiratory events is calculated by the central controller 4230. This is repeated on the same inspiratory event for the second such point, and so on. Thus, for example, 65 scaled data points are generated by the central controller 4230 and represent a moving average of the previous few inspiratory events (e.g., three events). The moving average of the continuously updated values ​​of the (e.g., sixty-five) points is hereinafter referred to as the "scaled flow" and is represented as Qs(t). Alternatively, a single inspiratory event can be used instead of a moving average.

[0524] From the scaled flow rates, two shape factors relevant to determining partial blockage can be calculated.

[0525] Shape Factor 1 is the ratio of the average of the intermediate (e.g., 32) scaled flow points to the overall average (e.g., 65) scaled flow points. In the event that this ratio exceeds one, the breath will be considered normal. In the event that this ratio is unity or less, the breath will be obstructed. A ratio of approximately 1.17 is used as the threshold between partially obstructed and unobstructed breaths and is equivalent to the degree of obstruction that allows adequate oxygenation in a typical patient.

[0526] Shape Factor 2 is calculated as the RMS deviation of unit scaled flow at the middle (e.g., 32) points. An RMS deviation of approximately 0.2 units is considered normal. A zero RMS deviation is considered a completely flow-limited breath. The closer the RMS deviation is to zero, the more flow-limited the breath is.

[0527] Shape factors 1 and 2 may be used as an alternative, or in combination. In other forms of the present technology, the number of sampling points, breaths, and intermediate points may be different from those described above. Furthermore, the thresholds may be different from those described.

[0528] 5.4.3.2.5 Determination of apnea and hypopnea

[0529] In one form of the present technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 for determining the presence of apnea and / or hypopnea.

[0530] In one form, the apnea / hypopnea determination algorithm 4325 receives as input the respiratory flow signal Qr and provides as output a flag indicating that apnea or hypopnea has been detected.

[0531] In one form, apnea is considered to have been detected when the function of respiratory flow Qr falls below a flow threshold for a predetermined period of time. The function may determine peak flow, a relatively short-term average flow, or an intermediate flow between the relatively short-term average and peak flow, such as RMS flow. The flow threshold may be a relatively long-term measure of flow.

[0532] In one form, hypopnea is considered to have been detected when the function of respiratory flow Qr falls below a second flow threshold over a predetermined period of time. The function may determine peak flow, a relatively short-term average flow, or an intermediate flow between the relatively short-term average and peak flow, such as RMS flow. The second flow threshold may be a relatively long-term flow measurement. The second flow threshold is greater than a flow threshold used to detect apnea.

[0533] 5.4.3.2.6 Determination of snoring

[0534] In one form of the present technology, the central controller 4230 executes one or more snore determination algorithms 4326 for determining the level of snoring.

[0535] In one form, the snore determination algorithm 4326 receives as input the respiratory flow signal Qr and provides as output a measure of the extent to which snoring is present.

[0536] The snore determination algorithm 4326 may include a step of determining the strength of the flow signal in the range of 30-300 Hz. Additionally, the snore determination algorithm 4326 may include a step of filtering the respiratory flow signal Qr to reduce background noise (eg, airflow sounds in the system from a blower).

[0537] 5.4.3.2.7 Determination of airway patency

[0538] In one form of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 for determining the degree of airway patency.

[0539] In one form, the airway patency determination algorithm 4327 receives as input the respiratory flow signal Qr and determines the power of the signal within a frequency range between approximately 0.75 Hz and approximately 3 Hz. The presence of a peak within this frequency range indicates an open airway. The absence of a peak is considered indicative of a closed airway.

[0540] In one form, the frequency range in which the peak is sought is the frequency of a small forced oscillation in the treatment pressure Pt. In one implementation, the frequency of the forced oscillation is 2 Hz and the amplitude is approximately 1 cmH2O.

[0541] In one form, the airway patency determination algorithm 4327 receives as input the respiratory flow signal Qr and determines whether a cardiogenic signal is present. The absence of a cardiogenic signal is considered indicative of a closed airway.

[0542] 5.4.3.2.8 Determination of target ventilation

[0543] In one form of the present technology, the central controller 4230 takes as input a measurement of current ventilation Vent and executes one or more target ventilation determination algorithms 4328 for determining a target value Vtgt for the ventilation measurement.

[0544] In some forms of the present technology, there is no target ventilation determination algorithm 4328 and the target value Vtgt is predetermined, for example, by hard coding during configuration of the RPT device 4000 or by manual entry via input device 4220 .

[0545] In other forms of the present technology, such as adaptive servo-ventilation (ASV), a target ventilation determination algorithm 4328 calculates a target value Vtgt from a value Vtyp indicative of the patient's typical recent ventilation.

[0546] In some forms of adaptive servo-ventilation, the target ventilation Vtgt is calculated as a high fraction of the typical recent ventilation Vtyp, but less than the typical recent ventilation Vtyp. The high fraction in these forms may be in the range of (80%, 100%), or (85%, 95%), or (87%, 92%).

[0547] In other forms of adaptive servo-ventilation, the target ventilation Vtgt is calculated as an integer multiple slightly larger than the typical recent ventilation Vtyp.

[0548] The typical recent ventilation Vtyp is a value around which the distribution of the measured values ​​of the current ventilation Vent at multiple moments in time on a predetermined time scale tends to cluster, that is, a measure of the central tendency of the measured values ​​of the current ventilation in the recent history. In one implementation of the target ventilation determination algorithm 4328, the recent history is on the order of a few minutes, but in any case should be longer than the time scale of the tidal breathing growth and decay cycle. The target ventilation determination algorithm 4328 can use any of a variety of well-known central tendency measures to determine the typical recent ventilation Vtyp based on the measured value of the current ventilation Vent. One such measure is the output of a low-pass filter on the measurement of the current ventilation outlet, where the time constant is equal to one hundred seconds.

[0549] 5.4.3.2.9 Determination of treatment parameters

[0550] In some forms of the present technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 for determining one or more treatment parameters using values ​​returned by one or more other algorithms in the treatment engine module 4320.

[0551] In one form of the present technology, the treatment parameter is the instantaneous treatment pressure Pt. In one implementation of this form, the treatment parameter determination algorithm 4329 determines the treatment pressure Pt using the following equation

[0552] Pt=AΠ(Φ,t)+P0 (1)

[0553] in:

[0554] A is the amplitude,

[0555] Π(Φ, t) is the waveform template value (in the range 0 to 1) for the current value of Φ at the phase at time and t, and

[0556] P0 is the base pressure.

[0557] If the waveform determination algorithm 4322 provides a waveform template Π(Φ, t) as a lookup table of values ​​Π indexed by phase Φ, the treatment parameter determination algorithm 4329 applies equation (1) by locating the closest lookup table entry to the current phase value Φ returned by the phase determination algorithm 4321, or by interpolating between two entries that span the current phase value Φ.

[0558] The values ​​of amplitude A and base pressure P0 can be set by therapy parameter determination algorithm 4329 in the following manner according to the selected respiratory pressure therapy mode.

[0559] 5.4.3.3 Treatment Control Module

[0560] The therapy control module 4330 according to one aspect of the present technology receives as input therapy parameters from the therapy parameter determination algorithm 4329 of the therapy engine module 4320 and controls the pressure generator 4140 to deliver airflow according to the therapy parameters.

[0561] In one form of the present technology, the therapy parameter is a therapy pressure Pt, and the therapy control module 4330 controls the pressure generator 4140 to deliver a flow of gas having an interface pressure Pm at the patient interface 3000 equal to the therapy pressure Pt.

[0562] 5.4.3.4 Detection of fault conditions

[0563] In one form of the present technology, the central controller 4230 executes one or more methods 4340 for detecting a fault condition. The fault condition detected by the one or more methods 4340 may include at least one of the following:

[0564] Power failure (no power or insufficient power)

[0565] Converter fault detection

[0566] Unable to detect the presence of components

[0567] Operating parameters are outside the recommended range (e.g., pressure, flow, temperature, PaO2).

[0568] The test alarm fails to generate a detectable alarm signal.

[0569] Upon detecting a fault condition, the corresponding algorithm 4340 signals the presence of a fault by one or more of the following:

[0570] Activate audible, visual, and / or dynamic (e.g., vibration) alarms

[0571] Send messages to external devices

[0572] Event log

[0573] 5.5 Air circuit

[0574] The air circuit 4170 according to one aspect of the present technology is a conduit or tube that, when in use, is constructed and arranged to allow air flow between two components, such as the RPT device 4000 and the patient interface 3000 .

[0575] In particular, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there can be separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.

[0576] In some forms, 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 temperature of the air. The heating element may be in the form of a heating wire loop and may include one or more transducers, such as a temperature sensor. In one form, the heating wire loop may be helically wound around the axis of the air circuit 4170. The heating element may be in communication with a controller, such as a central controller 4230. One embodiment of an air circuit 4170 including a heating wire loop is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0577] 5.5.1 Assisted Gas Delivery

[0578] In one form of the present technology, supplemental gas (e.g., oxygen) 4180 is delivered to one or more points in the pneumatic pathway, such as upstream of the pneumatic block 4020 , to the air circuit 4170 , and / or to the patient interface 3000 or 3800 .

[0579] 5.6 Humidifier

[0580] 5.6.1 Humidifier Overview

[0581] In one form of the present technology, a humidifier 5000 is provided (e.g., as in Figure 11A ) to change the absolute humidity of air or gas for delivery to a patient relative to ambient air. Typically, a humidifier 5000 is used to increase the absolute humidity of an air stream and increase the temperature of the air stream (relative to ambient air) before delivery to the patient's airway.

[0582] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering a humidified air flow. Figure 11A and 11B As shown, the inlet and outlet of the humidifier reservoir 5110 can be respectively a humidifier inlet 5002 and a humidifier outlet 5004. The humidifier 5000 can also include a humidifier base 5006, which can be adapted to receive the humidifier reservoir 5110 and include a heating element 5240.

[0583] 5.6.2 Humidifier components

[0584] 5.6.2.1 Water reservoir

[0585] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to hold or retain a volume of liquid (e.g., water) to evaporate for humidifying the air flow. The water reservoir 5110 may be configured to hold a predetermined maximum water volume so as to provide adequate humidification for at least the duration of a respiratory therapy session, such as one night of 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 other embodiments, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply.

[0586] According to one aspect, water reservoir 5110 is configured to humidify air flow from RPT device 4000 as the air flow passes therethrough. In one form, water reservoir 5110 may be configured to encourage air flow to travel in a tortuous path through reservoir 5110 when in contact with the water content therein.

[0587] According to one form, the reservoir 5110 may be arranged, for example, along Figure 11A and Figure 11B Lateral orientation shown removed from humidifier 5000.

[0588] The reservoir 5110 may also be configured to prevent liquid from flowing out of any of the apertures and / or between its subassemblies, such as when the reservoir 5110 is displaced and / or rotated from its normal operating orientation. Since the air flow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to avoid loss of pneumatic pressure through leakage and / or flow resistance.

[0589] 5.6.2.2 Conductive part

[0590] According to one arrangement, the reservoir 5110 includes an air guide 5120 that is configured to allow efficient transfer of heat from the heating element 5240 to the liquid volume in the reservoir 5110. In one form, the air guide 5120 can be arranged as a plate, but other shapes are also applicable. All or a portion of the air guide 5120 can be made of a thermally conductive material, such as aluminum (e.g., having a thickness of about 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity can be achieved using a material with a suitable geometric structure that has a lower conductivity.

[0591] 5.6.2.3 Humidifier reservoir dock

[0592] In one form, the humidifier 5000 may include a humidifier reservoir base 5130 (e.g., Figure 11B), which is configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include a locking structure, such as a locking rod 5135 configured to retain the reservoir 5110 in the humidifier reservoir base 5130.

[0593] 5.6.2.4 Water level indicator

[0594] The humidifier reservoir 5110 may include Figures 11A-11B Water level indicator 5150 is shown. In some forms, water level indicator 5150 may provide a user (such as patient 1000 or a caregiver) with one or more indications regarding the amount of water volume in humidifier reservoir 5110. The one or more indications provided by water level indicator 5150 may include an indication of a maximum predetermined capacity of water, any fraction thereof, such as 25%, 50%, 75%, or a capacity such as 200 ml, 300 ml, or 400 ml.

[0595] 5.6.2.5 Humidifier Converter

[0596] 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 sensor 5210 may include one or more air pressure sensors 5212, air flow sensors 5214, temperature sensors 5216, or humidity sensors 5218, such as Figure 11C The humidifier converter 5210 can generate one or more output signals that can be sent to a controller, such as the central controller 4230 and / or the humidifier controller 5250. In some forms, the humidifier converter can be located external to the humidifier 5000 (such as in the air circuit 4170) when sending the output signals to the controller.

[0597] 5.6.2.5.1 Pressure converter

[0598] The humidifier 5000 may be provided with one or more pressure transducers 5212 in place of or in addition to the pressure sensor 4272 provided in the RPT device 4000 .

[0599] 5.6.2.5.2 Flow Converter

[0600] The humidifier 5000 may be provided with one or more flow transducers 5214 in place of or in addition to the flow sensor 4274 provided in the RPT device 4000 .

[0601] 5.6.2.5.3 Temperature converter

[0602] 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 temperature of the heating element 5240 and / or the temperature of the air flow downstream of the humidifier outlet 5004. In some forms, the humidifier 5000 may also include a temperature sensor 5216 for detecting the ambient air temperature.

[0603] 5.6.2.5.4 Humidity Converter

[0604] In some forms, the humidifier 5000 may include one or more humidity sensors 5218 that detect the humidity of a gas (such as ambient air). In some forms, the humidity sensor 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.

[0605] 5.6.2.6 Heating elements

[0606] In some cases, a heating element 5240 can be provided to the humidifier 5000 to provide heat input to one or more of the water volumes in the humidifier reservoir 5110 and / or to the air flow. The heating element 5240 can include a heat generating component, such as a resistive electric heating rail. One suitable example of a heating element 5240 is a layered heating element, such as that described in PCT Patent Application Publication No. WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0607] In some forms, the heating element 5240 may be provided in the humidifier base 5006, where Figure 11B As shown in , heat can be provided to the humidifier reservoir 5110 primarily by conduction.

[0608] 5.6.2.7 Humidifier Controller

[0609] According to one arrangement of the present technology, the humidifier 5000 may include Figure 11C Humidifier controller 5250 is shown. In one form, humidifier controller 5250 may be part of central controller 4230. In another form, humidifier controller 5250 may be a standalone controller that may communicate with central controller 4230.

[0610] In one form, the humidifier controller 5250 may receive as input, for example, measurements of air flow, water properties (such as temperature, humidity, pressure, and / or flow) in the reservoir 5110 and / or the humidifier 5000. The humidifier controller 5250 may also be configured to execute or implement a humidifier algorithm and / or deliver one or more output signals.

[0611] 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 heating element controller 5252 constructed to control the temperature of the heating element 5240.

[0612] 5.7 Screening, Diagnosis, and Monitoring Systems

[0613] 5.7.1 Overview

[0614] At least some forms of the present technology allow for the use of sensors incorporated into a patient interface to screen, diagnose, and / or monitor sleep health. The sensors may be disposed within a positioning and stabilizing structure of the patient interface, such as a Figure 9A and 9B The positioning and stabilizing structure 11300 is provided in the pneumatic chamber of the patient interface.

[0615] For example, as described above, a sensor-enabled positioning and stabilizing structure in the form of a headband, such as positioning and stabilizing structure 6300 or 11300, can be worn by the patient as a headband before starting treatment, and sensor measurements recorded during sleep. The sensor measurements can be used to accurately monitor sleep stages and sleep positions, track vital signs and other physiological indicators, and detect apnea and / or hypopnea events. Clinicians can use the sleep data and physiological data to diagnose sleep disorders and recommend appropriate treatment. In addition, the same parameters can be monitored by sensors during treatment and compared with the parameters before starting treatment (or at an earlier stage of treatment) to enable the patient and clinician to evaluate the efficacy of the treatment.

[0616] As described above, physiological and sleep data may be recorded by one or more sensors of the patient interface and transmitted to an external computing device, such as the patient's smartphone, and / or a monitoring server operated or accessible by a clinician or other healthcare provider.

[0617] In some forms of the present technology, a pulse oximeter incorporated into the positioning and stabilizing structure 11300 can be used to determine blood oxygen saturation levels and heart rate while the patient interface 11000 is worn, and this data can be transmitted to an external computing device, such as a smartphone, other mobile computing device, or the patient's laptop or desktop computing system. The data can include time series data that can be combined to provide feedback to the patient about their health level and recommendations for follow-up (e.g., by a clinician). For example, this can be based on the determination of the AHI as described above, which can be used in conjunction with other sensor measurements to determine when apneic events occur and how often they occur. This data can also be used to design an optimal treatment plan for the patient.

[0618] Other sensors that may be incorporated into a screening, diagnostic and / or monitoring system that includes a sensor-enabled patient interface include, but are not limited to: an EEG sensor for detecting sleep stages; EMG and EOG sensors for determining REM sleep stage events; a microphone for detecting snoring or other sounds indicative of disturbed sleep; a humidity sensor, a temperature sensor, a pressure sensor and / or a CO2 sensor all disposed within the pneumatic chamber 11200 of the patient interface.

[0619] Some example applications of sensor-enabled patient interfaces will now be described.

[0620] 5.7.2 Polysomnography

[0621] Polysomnography (PSG) is a monitoring procedure that typically involves a variety of different sensors and associated devices, and can be challenging to install even for experts. A typical PSG system includes a head box that receives and records signals from the following sensors: EOG electrodes; EEG electrodes; ECG electrodes; sub-medial EMG electrodes; snoring sensor; respiratory inductance plethysmography (respiratory effort sensor) on a chest strap; respiratory inductance plethysmography (respiratory effort sensor) on an abdominal strap; an oral and nasal cannula with an oral thermistor; photoplethysmography (pulse oximeter); and a body position sensor. The electrical signals are referred to a ground electrode (ISOG) located in the center of the forehead.

[0622] A sensor-enabled patient interface, such as patient interface 11000, can replace some or all of the functionality of existing PSG systems because, as described above, some or all of the sensors used by a PSG system can be disposed in the positioning and stabilizing structure (e.g., 11300) and / or in the pneumatic chamber (e.g., 11200). For example, EOG, EEG, ECG, and EMG electrodes, a microphone (for use as a snoring sensor), a PPG sensor, and an accelerometer and / or gyroscope (for use as a body position sensor) can all be disposed in the upper fabric portion 11310 and / or the lower fabric portions 11308, 11320 of the positioning and stabilizing structure 11300. A ground electrode can also be provided (e.g., in the lower fabric portion 11308 for placement behind the patient's ear, as described above).

[0623] By integrating the sensors with the patient interface 11000, in at least some examples, implementing PSG becomes more straightforward because the patient is able to simply wear the patient interface 11000 in the manner they would do for therapy, with no or minimal additional configuration required (e.g., no need to manually place various electrodes for EEG / EMG / EOG sensors).

[0624] 5.7.3 Non-intrusive monitoring system

[0625] In one example, one or more accelerometers and / or one or more gyroscopes and / or one or more other motion sensors may be provided in the positioning and stabilizing structure 11300. The motion sensors are configured to generate one or more signals representing the patient's body motion, from which a signal representing the patient's respiratory motion may be derived.

[0626] 5.7.4 Respiratory polysomnography

[0627] Respiratory polysomnography (RPG) is a term for a simplified form of PSG without electrical signals (EOG, EEG, EMG), snoring, or body position sensors. Typically, an RPG includes at least a chest motion signal from a respiratory induction plethysmogram (motion sensor) on a chest strap, a nasal pressure signal sensed via a nasal cannula, and an oxygen saturation signal from a pulse oximeter (e.g., a pulse oximeter). The three RPG signals, or channels, are received by the RPG headbox.

[0628] A sensor-enabled patient interface, such as patient interface 11000, can replace some or all of the functionality of an existing RPG system. For example, accelerometer and / or gyroscope measurements from sensors mounted in headband 11300 can be used as a proxy for chest motion signals. A nasal pressure signal can be measured by a pressure sensor mounted within the pneumatic chamber, for example, mounted on an inner surface within the pneumatic chamber so as to be located near the patient's nostrils when in use. An oxygen saturation signal can be measured by a PPG sensor mounted in headband 11300, for example, Figure 9C The proxy chest motion signal, nasal pressure signal, and oxygen saturation signal may be received by the onboard processor 11350 of the patient interface 11000 and / or may be transmitted to an external computing device for analysis in the same manner as conventional RPG signals.

[0629] In some configurations, the nasal pressure signal is a satisfactory representation of the nasal flow signal generated by a flow sensor in line with the sealing nasal mask because the nasal pressure signal is comparable in shape to the nasal flow signal. If the patient's mouth remains closed, i.e., there is no mouth leak, then the nasal flow is equal to the respiratory flow.

[0630] 5.8 Portable Oxygen Concentrator (POC)

[0631] Portable oxygen concentrators can utilize pressure swing adsorption (PSA). Pressure swing adsorption can include using one or more compressors to increase the pressure of gas within a tank containing gas-separating adsorbent particles arranged in a "sieve bed." As the pressure increases, certain molecules in the gas may be adsorbed onto the gas-separating adsorbent. Removing a portion of the gas in the tank under pressurized conditions allows the non-adsorbed molecules to separate from the adsorbed molecules. The gas-separating adsorbent can be regenerated by reducing the pressure, which reverses the adsorption of molecules from the adsorbent. More details about oxygen concentrators can be found, for example, in U.S. Published Patent Application No. 2009-0065007, entitled "Oxygen Concentrator Apparatus and Method," published on March 12, 2009, which is incorporated herein by reference.

[0632] Ambient air typically consists of approximately 78% nitrogen and 21% oxygen, with the balance made up of argon, carbon dioxide, water vapor, and other trace gases. If a gas mixture, such as air, is passed under pressure through a tank containing a bed of a gas separation adsorbent that attracts nitrogen more strongly than oxygen, some or all of the nitrogen will remain in the bed, and the gas emerging from the tank will be enriched in oxygen. When the bed's ability to adsorb nitrogen has expired, it can be regenerated by reducing the pressure, thereby releasing the adsorbed nitrogen. Another cycle of producing oxygen-enriched air is then ready. By alternating the tanks in a dual tank system, one tank can separate oxygen while the other is being purged (resulting in a continuous separation of oxygen from nitrogen). In this way, oxygen-enriched air can be accumulated, such as in a storage container or other pressurizable container or conduit connected to the tank, for a variety of uses, including providing supplemental oxygen to a patient.

[0633] 5.9 Respiratory Therapy Mode

[0634] Various respiratory therapy modes can be achieved with the disclosed respiratory therapy system.

[0635] 5.9.1 CPAP therapy

[0636] In some implementations of respiratory pressure therapy, the central controller 4230 sets the therapy pressure Pt according to the therapy pressure equation as part of the therapy parameter determination algorithm 4329. In one such implementation, the amplitude A is also zero, so the therapy pressure Pt (which represents the target value achieved by the interface pressure Pm at the current moment) is also equal to the baseline pressure P0 throughout the respiratory cycle. Such implementations are generally grouped under the heading of CPAP therapy. In such implementations, the therapy engine module 4320 does not need to determine the phase Φ or the waveform template Π(Φ).

[0637] In CPAP therapy, the basal pressure P0 can be a constant value hard-coded or manually input into the RPT device 4000. Alternatively, the central controller 4230 can repeatedly calculate the basal pressure P0 as a function of an indicator or measure of sleep-disordered breathing, such as one or more of flow limitation, apnea, hypopnea, patency, and snoring, returned by a corresponding algorithm in the therapy engine module 4320. Such an option is sometimes referred to as APAP therapy.

[0638] Figure 10E is a flow chart illustrating a method 4500 performed by the central controller 4230 for continuously calculating a basal pressure P0 as part of an APAP therapy implementation of the therapy parameter determination algorithm 4329 when pressure support A is equal to zero.

[0639] Method 4500 begins at step 4520, where the central controller 4230 compares the 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 for a predetermined period of time, thereby indicating that apnea / hypopnea is occurring. If so, the method 4500 proceeds to step 4540; otherwise, the method 4500 proceeds to step 4530. At step 4540, the central controller 4230 compares the 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 the method 4500 proceeds to step 4560; otherwise, the apnea / hypopnea is considered obstructive and the method 4500 proceeds to step 4550.

[0640] At step 4530, central controller 4230 compares the measure of flow limitation to a third threshold. If the measure of flow limitation exceeds the third threshold, indicating that inspiratory flow is limited, method 4500 proceeds to step 4550; otherwise, method 4500 proceeds to step 4560.

[0641] At step 4550, the central controller 4230 increases the base pressure P0 by a predetermined pressure increment P, as long as the resulting treatment pressure Pt does not exceed the maximum treatment pressure P max In one implementation, the predetermined pressure increment P and the maximum treatment pressure P max In other implementations, the pressure increment P can 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 treatment pressure P max It can be as low as 15 cmH 2 O and as high as 35 cmH 2 O, or as low as 20 cmH 2 O and as high as 30 cmH 2 O. The method 4500 then returns to step 4520.

[0642] In step 4560, the central controller 4230 reduces the base pressure P0 by a decrement as long as the reduced base pressure P0 does not drop below the minimum treatment pressure Pmin. The method 4500 then returns to step 4520. In one implementation, the reduction amount is proportional to the value of P0-pmin, so that in the absence of any detected events, the reduction of P0 to the minimum treatment pressure Pmin is exponential. In one implementation, the proportionality constant is set so that the time constant of the exponential reduction of P0 is 60 minutes and the minimum treatment pressure Pmin is 4 cmH2O. In other implementations, the time constant can 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 treatment pressure Pmin can 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, the reduction of P0 can be predetermined so that in the absence of any detected events, the reduction of P0 to the minimum treatment pressure Pmin is linear.

[0643] 5.9.2 Bi-level treatment

[0644] In other implementations of this form of the present technology, the value of the amplitude A in equation (1) can be positive. Such implementations are referred to as bi-level therapy because, when determining the treatment pressure Pt using equation (1) with a positive amplitude A, the treatment parameter determination algorithm 4329 oscillates the treatment pressure Pt between two values ​​or levels in synchronization with the spontaneous respiratory effort of the patient 1000. That is, based on the above-described typical waveform template Π(Φ), the treatment parameter determination algorithm 4329 increases the treatment pressure Pt to P0+A (referred to as IPAP) at the beginning or during inspiration, and reduces the treatment pressure Pt to the base pressure P0 (referred to as EPAP) at the beginning or during expiration.

[0645] In some forms of bi-level therapy, IPAP is a treatment pressure that serves the same purpose as the treatment pressure in the CPAP therapy mode, while EPAP is IPAP minus Amplitude A, which has a "small" value (a few cmH2O), sometimes referred to as Expiratory Pressure Relief (EPR). This type of therapy is sometimes referred to as CPAP therapy with EPR, which is generally considered more comfortable than straight CPAP therapy. In CPAP therapy with EPR, both IPAP and EPAP can be constant values ​​that are hard-coded or manually entered into the RPT device 4000. Alternatively, the therapy parameter determination algorithm 4329 can repeatedly calculate IPAP and / or EPAP during CPAP with EPR. In this alternative, the therapy parameter determination algorithm 4329 repeatedly calculates EPAP and / or IPAP in a manner similar to the calculation of the basal pressure P0 in APAP therapy described above, as a function of an indicator or measure of sleep-disordered breathing returned by the corresponding algorithm in the therapy engine module 4320.

[0646] In other forms of bi-level therapy, Amplitude A is large enough to cause RPT device 4000 to perform some or all of the work of breathing for patient 1000. In such forms, known as pressure support ventilation therapy, Amplitude A is referred to as pressure support or oscillation. In pressure support ventilation therapy, IPAP is the base pressure P0 plus pressure support A, and EPAP is the base pressure P0.

[0647] In some forms of pressure support therapy, referred to as fixed pressure support therapy, pressure support A is fixed at a predetermined value, such as 10 cm HO. The predetermined pressure support value is a setting of the RPT device 4000 and can be set, for example, by hard coding during configuration of the RPT device 4000 or by manual entry through the input device 4220.

[0648] In other forms of pressure support ventilation therapy, broadly referred to as servo-ventilation, a therapy parameter determination algorithm 4329 takes as input some currently measured or estimated parameter of the respiratory cycle (e.g., a current measure of ventilation, Vent) and a target value for that respiratory parameter (e.g., a target value of ventilation, Vtgt), and repeatedly adjusts the parameters of equation (1) to move the current measure of the respiratory parameter toward 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, as described above.

[0649] In some forms of servo-ventilation, the therapy parameter determination algorithm 4329 applies a control method to repeatedly calculate the pressure support A in order to move the current measurement of the respiratory parameter toward the target value. One such control method is proportional-integral (PI) control. In one implementation of PI control, suitable for ASV mode in which the target ventilation Vtgt is set slightly less than the typical recent ventilation Vtyp, the pressure support A is repeatedly calculated as:

[0650] A=G∫(Vent-Vtgt)dt (2)

[0651] Where G is the gain of the PI control. Larger values ​​of gain G can result in positive feedback in the therapy engine module 4320. Smaller values ​​of gain G can allow for some residual untreated CSR or central sleep apnea. In some implementations, gain G is fixed at a predetermined value, such as -0.4 cmH2O / (L / min) / sec. Alternatively, gain G can vary between therapy sessions, starting smaller from one session and increasing from one session to another until a value is reached that substantially eliminates CSR. Conventional means for retrospectively analyzing parameters of therapy sessions to assess the severity of CSR during a therapy session can be employed in such implementations. In other implementations, gain G can vary based on the difference between a current measurement of ventilation, Vent, and a target ventilation, Vtgt.

[0652] Other servo-ventilation control methods that may be applied by the therapy parameter determination algorithm 4329 include proportional (P), proportional-derivative (PD), and proportional-integral-derivative (PID).

[0653] The value of pressure support A calculated via Equation 2 can be clipped to a range defined as [Amin, Amax]. In this implementation, pressure support A defaults to a minimum pressure support value, Amin, until the measured value of the current ventilation, Vent, falls below the target ventilation, Vtgt, at which point A begins to increase, and only falls back to Amin when Vent again exceeds Vtgt.

[0654] The pressure support limits Amin and Amax are settings of the RPT device 4000 , such as by hard coding during configuration of the RPT device 4000 or by manual entry through the input device 4220 .

[0655] In pressure support ventilation therapy mode, EPAP is the base pressure P0. As with the base pressure P0 in CPAP therapy, EPAP can be a constant value that is specified or determined during a titration period. Such a constant EPAP can be set, for example, by hard coding during configuration of the RPT device 4000 or by manual entry via the input device 4220. This alternative is sometimes referred to as fixed-EPAP pressure support ventilation therapy. Clinician Titration of a patient's EPAP can be performed by a clinician during titration with the aid of PSG with the goal of preventing obstructive apnea and thereby maintaining an open airway for pressure support ventilation therapy in a manner similar to the titration of the base pressure P0 in constant CPAP therapy.

[0656] Alternatively, the therapy parameter determination algorithm 4329 can repeatedly calculate the basal pressure P0 during pressure support ventilation therapy. In such an implementation, the therapy parameter determination algorithm 4329 repeatedly calculates EPAP as a function of an indicator or metric of sleep-disordered breathing, such as one or more of flow limitation, apnea, hypopnea, patency, and snoring, returned by a corresponding algorithm in the therapy engine module 4320. Because the continuous calculation of EPAP is similar to the manual adjustment of EPAP by a clinician during EPAP titration, this process is sometimes referred to as automatic titration of EPAP, and the therapy mode is referred to as automatically titrating EPAP pressure support ventilation therapy or automatic EPAP pressure support ventilation therapy.

[0657] 5.10 Glossary

[0658] For purposes of this technology disclosure, in some forms of the technology, one or more of the following definitions may apply. In other forms of the technology, alternative definitions may apply.

[0659] 5.10.1 Overview

[0660] Air: in some forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as oxygen-enriched air.

[0661] Environment: Environment: In certain forms of the present technology, the term environment can have the following meanings: (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0662] For example, the ambient humidity relative to the humidifier may be the humidity of the air immediately surrounding the humidifier, such as the humidity within a room that a patient is sleeping in. Such ambient humidity may be different from the humidity outside the room that the patient is sleeping in.

[0663] In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

[0664] In some forms, ambient (e.g., acoustic) noise can be considered to be the background noise level in the room the patient is in, in addition to noise generated, for example, by the RPT device or from a mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0665] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which therapy pressure is automatically adjusted between minimum and maximum limits, eg, from breath to breath, based on the presence or absence of an indication of an SDB event.

[0666] Continuous Positive Airway Pressure (CPAP) therapy: A respiratory pressure therapy in which the therapy pressure can be approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction and decreasing in the absence of an indication of partial upper airway obstruction.

[0667] Flow: The volume (or mass) of air delivered per unit time. Flow may refer to an instantaneous quantity. In some cases, reference to flow will be to a scalar quantity, i.e., a quantity having only magnitude. In other cases, reference to flow will be to a vector quantity, i.e., a quantity having both magnitude and direction. Flow may be given the symbol Q. "Flow" is sometimes shortened to simply "flow" or "airflow."

[0668] In the example of a patient breathing, the flow rate can be nominally positive for the inspiratory portion of the patient's breathing cycle and therefore negative for the expiratory portion of the patient's breathing cycle. The device flow rate, Qd, is the flow rate of air leaving the RPT device. The total flow rate, Qt, is the flow rate of air and any supplemental gas that reaches the patient interface via the air circuit. The ventilation flow rate, Qv, is the flow rate of air leaving the vent to allow for flushing of exhaled gases. The leakage flow rate, Ql, is the leakage flow from the patient interface system or elsewhere. The respiratory flow rate (Qr) is the flow rate of air received into the patient's respiratory system.

[0669] Flow Therapy: Respiratory therapy that involves delivering air flow to the airway entrance at a controlled flow rate, called the therapy flow, which is usually positive throughout the patient's respiratory cycle.

[0670] Humidifier: The term humidifier shall be understood as a humidifying device constructed and arranged, or constructed with a physical structure, capable of providing a therapeutically beneficial amount of water (H2O) vapor to a flow of air to improve a patient's medical respiratory condition.

[0671] Leakage: The term leakage is to be understood as undesirable air flow. 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 the return bend to the surrounding environment.

[0672] Noise, Conducted (Acoustic): Conducted noise in this document refers to the noise brought to the patient through the pneumatic path (such as the air circuit and patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0673] Noise, radiated (acoustic): Radiated noise in this document refers to the noise that is brought to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0674] Noise, ventilation (acoustic): Ventilation noise in this document refers to the noise generated by the flow of air through any ventilation aperture, such as the vent aperture of a patient interface.

[0675] Oxygen-enriched air: air with an oxygen concentration greater than that of atmospheric air (21%), such as 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% oxygen. "Oxygen-enriched air" is sometimes referred to simply as "oxygen."

[0676] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or greater.

[0677] Patient: A person, whether or not they have a respiratory illness.

[0678] Pressure: force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm 2 and hectopascal. 1 cmH2O is equal to 1 g-f / cm 2 And about 0.98 hectopascal (1 hectopascal = 100 Pa = 100 N / m 2 =1 mbar to 0.001 atm). In this specification, unless otherwise stated, pressure is given in cmH2O.

[0679] The pressure in the patient interface is given the symbol Pm, while the treatment pressure is given the symbol Pt, which represents the target value to be achieved by the interface pressure Pm at the current moment.

[0680] Respiratory Pressure Therapy (RPT): The application of a supply of air to the airway entrance at a therapeutic pressure that is typically positive relative to atmosphere.

[0681] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0682] 5.10.1.1 Materials

[0683] Silicone or Silicone Elastomer: A synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0684] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0685] Fabric: A flexible material formed from a web of fibers that can be natural, man-made, or a combination thereof. Fibers (e.g., wool, linen, cotton, hemp, and / or rayon) can be spun into yarns that are woven, knitted, crocheted, knotted, woven, felted, and / or braided to form a fabric. As used herein, the terms "fabric" and "textile" are interchangeable.

[0686] 5.10.1.2 Mechanical properties

[0687] Elasticity: The ability of a material to absorb energy when elastically deformed and release that energy when unloaded.

[0688] Resilient: Releases substantially all of its energy when deflated. Includes, for example, certain silicones and thermoplastic elastomers.

[0689] Hardness: The ability of a material to resist deformation (e.g., as described by Young's modulus or the indentation hardness scale measured on a standardized sample size).

[0690] • "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may deform easily, for example, under finger pressure.

[0691] • "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and may not deform easily, for example, under finger pressure.

[0692] Stiffness (or rigidity) of a structure or component: The ability of the structure or component to resist deformation in response to an applied load. The load can be a force or a moment, such as compression, tension, bending, or torsion. The structure or component can offer different resistance in different directions. The reciprocal of stiffness is compliance.

[0693] Floppy structure or component: A structure or component that will change shape (eg, bend) within a relatively short period of time (such as 1 second) when made to support its own weight.

[0694] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such use might be placing and maintaining a patient interface in sealing relationship with the entrance to a patient's airway, e.g., under a load of approximately 20 to 30 cmH2O pressure.

[0695] As an example, an I-beam may include different bending stiffness (resistance to bending loads) in a first direction compared to a second, orthogonal direction.In another example, a structure or component may be flexible in a first direction and rigid in a second direction.

[0696] 5.10.2 Respiratory cycle

[0697] Apnea: According to some definitions, apnea is considered to occur when flow drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway does not allow air flow despite the patient's efforts. Central apnea is considered to occur when apnea is detected due to a decrease or absence of respiratory effort despite a patent airway. Mixed apnea is considered to occur when a decrease or absence of respiratory effort occurs simultaneously with an obstructed airway.

[0698] Respiratory rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0699] Duty cycle: the ratio of inspiratory time Ti to total breathing time Ttot.

[0700] Effort (breathing): The effort made by a spontaneously breathing person trying to breathe.

[0701] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0702] Flow Limitation: Flow limitation is considered a state of event in a patient's breathing in which an increase in patient effort does not result in a corresponding increase in flow. When flow limitation occurs during the inspiratory portion of the respiratory cycle, it can be described as inspiratory flow limitation. When flow limitation occurs during the expiratory portion of the respiratory cycle, it can be described as expiratory flow limitation.

[0703] Types of flow-limited inspiratory waveforms:

[0704] (i) Flattened: having an ascent followed by a relatively flat section and then a descent.

[0705] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, with a relatively flat portion between the two peaks.

[0706] (iii) Chair shape: has a single local peak at the leading edge, followed by a relatively flat portion.

[0707] (iv) Reverse chair shape: has a relatively flat section followed by a single local peak located at the trailing edge.

[0708] Hypopnea: According to some definitions, hypopnea is considered a decrease in flow rather than a cessation of flow. In one form, hypopnea is considered to occur when flow decreases below a threshold for a sustained period of time. Central hypopnea is considered to occur when hypopnea is detected due to a decrease in respiratory effort. In one form in adults, any of the following may be considered hypopnea:

[0709] (i) A 30% decrease in the patient's breathing lasting at least 10 seconds with an associated 4% desaturation; or

[0710] (ii) A decrease (but at least 50%) in the patient's breathing lasting at least 10 seconds, with an associated desaturation or arousal of at least 3%.

[0711] Hyperpnea: Increased air flow to a higher than normal level.

[0712] Inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0713] Patency (airway): The degree to which the airway is open, or the degree to which the airway is open. An open airway is open. Airway patency can be quantified, for example with a value of (1) for open and a value of zero (0) for closed (obstructed).

[0714] Positive End-Expiratory Pressure (PEEP): The pressure above atmospheric pressure that exists in the lungs at the end of exhalation.

[0715] Peak flow (Qpeak): The maximum flow rate during the expiratory portion of the respiratory flow waveform.

[0716] Respiratory flow, patient air flow, respiratory air flow (Qr): These terms may be understood to refer to the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow," which is the actual respiratory flow experienced by the patient, typically expressed in liters per minute.

[0717] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing when no additional effort is exerted. In principle, the inspiratory volume Vi (the volume of air inhaled) is equal to the expiratory volume Ve (the volume of air exhaled), so a single tidal volume Vt can be defined as equal to either volume. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, such as an average.

[0718] (Inspiratory) Time (Ti): Duration of the inspiratory portion of the respiratory flow waveform.

[0719] (Expiratory) Time (Te): Duration of the expiratory portion of the respiratory flow waveform.

[0720] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of one respiratory flow waveform and the start of the inspiratory portion of the subsequent respiratory flow waveform.

[0721] Typical recent ventilation: The ventilation value around which recent ventilation values ​​Vent tend to cluster over some predetermined time scale, ie a measure of the central tendency of recent ventilation values.

[0722] Upper airway obstruction (UAO): includes both partial and total upper airway obstruction. This may be associated with a state of flow limitation, where flow increases only slightly, or even decreases, as the pressure differential across the upper airway increases (Starling impedance behavior).

[0723] Ventilation (Vent): A measurement of the flow of gases exchanged by a patient's respiratory system. Ventilation measurements can include either or both inspiratory and expiratory flow (per unit time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes given simply as volume and is understood to be the volume per minute.

[0724] 5.10.3 Ventilation volume

[0725] Adaptive Servo Ventilator (ASV): A servo ventilator with a variable rather than fixed target ventilation. The variable target ventilation may be derived from some characteristic of the patient (e.g., the patient's breathing characteristics).

[0726] Backup Rate: A parameter of a ventilator that determines the minimum rate of breaths (usually measured in breaths per minute) that the ventilator will deliver to the patient if not triggered by spontaneous respiratory effort.

[0727] Cycling: The termination of the inspiratory phase of a ventilator. When a ventilator is delivering a breath to a spontaneously breathing patient, at the end of the inspiratory portion of the respiratory cycle, the ventilator is considered to have cycled to stop delivering a breath.

[0728] Expiratory Positive Airway Pressure (EPAP): The base pressure to which intra-breath varying pressures are added to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0729] End-Expiratory Pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory portion. If the pressure waveform template Π(Φ) is zero at the end of exhalation, that is, when Φ=1, Π(Φ)=0, then EEP is equal to EPAP.

[0730] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of a breath.

[0731] Pressure Support: A number that indicates the increase in pressure during ventilator inspiration over the pressure during ventilator expiration, and usually refers to the difference between the maximum pressure during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference that the ventilator aims to achieve, rather than the difference that is actually achieved.

[0732] Servo ventilator: A ventilator that measures patient ventilation, has a target ventilation volume, and adjusts the level of pressure support to bring the patient's ventilation to the target ventilation volume.

[0733] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the initiation of a breath in a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined period of time, the device will automatically initiate the delivery of a breath.

[0734] Swing: A term equivalent to pressure support.

[0735] Triggering: When a ventilator or other respiratory therapy device (such as an RPT device or portable oxygen concentrator) delivers a volume of breathable gas to a spontaneously breathing patient, it is said to be triggered to do so. Triggering typically occurs at or near the time the patient is making an effort to initiate the breath portion of the breathing cycle.

[0736] 5.10.4 Anatomy

[0737] 5.10.4.1 Facial anatomy

[0738] Ala: The outer lining or "wing" of each nostril (plural: alar)

[0739] Wing angle:

[0740] Alar tip: The outermost point on the wing of the nose.

[0741] Alar inflection (or alar apex) point: The most posterior point in the base of the curvature of each ala, found in the wrinkle formed by the union of the ala and cheek.

[0742] Pinna: The entire external, visible part of the ear.

[0743] (Nose) Skeleton: The skeleton of the nose includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0744] (Nose) Cartilage framework: The cartilage framework of the nose includes septal cartilages, lateral cartilages, major cartilages and minor cartilages.

[0745] Columella: The strip of skin that separates the nostrils and extends from the protruding point of the nose to the upper lip.

[0746] Columellar angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt plane (where both lines intersect at the lower point of the nasal septum).

[0747] Frankfurt horizontal plane: A line extending from the lowest point of the orbital margin to the left oblique area. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0748] Glabella: The most prominent point on the forehead in the midsagittal plane located on the soft tissue.

[0749] Lateral nasal cartilage: A generally triangular plate of cartilage with its upper edge attached to the nasal bones and the frontal process of the maxilla and its lower edge connected to the greater alar cartilage.

[0750] Lower lip (midpoint of lower lip):

[0751] Upper lip (midpoint of upper lip):

[0752] The greater alar cartilage is a cartilaginous plate located beneath the lateral nasal cartilage. It curves around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane that contains three or four smaller cartilages of the alar.

[0753] Nostril: The roughly oval-shaped opening that forms the entrance to the nasal cavity. The singular form of "nare" is "naris." The nostrils are separated by the nasal septum.

[0754] Nasolabial folds or nasolabial wrinkles: Folds or grooves of skin that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0755] Nasolabial angle: the angle between the columella and the upper lip (which intersect at the subnasal point).

[0756] Auricular base: The lowest point where the auricle attaches to the facial skin.

[0757] Auricular base: The highest point where the auricle attaches to the facial skin.

[0758] Nasal protuberance: The most prominent point or tip of the nose that can be identified in a side view of the rest of the head.

[0759] Philtrum: The midline groove that extends from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0760] Chin point: The front midpoint of the chin located on the soft tissue.

[0761] Ridge (nose): The nasal ridge is the midline projection of the nose extending from the nasal bridge point to the nasal protuberance point.

[0762] Sagittal plane: A vertical plane running from front (anterior) to back (posterior). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0763] Nasal bridge point: The most concave point on the soft tissue covering the forehead and nasal suture area.

[0764] Septal Cartilage (Nose): The septal cartilage forms part of the nasal septum and divides the front of the nasal cavity.

[0765] Infraalar: The point at the lower edge of the ala base where the ala base joins the skin of the upper (superior) lip.

[0766] Subnasal point: The point on the soft tissue where the columella and upper lip meet in the midsagittal plane.

[0767] Mandibular alveolar seat: The point of maximum concavity on the midline of the lower lip between the midpoint of the lower lip and the premental point of the soft tissue

[0768] 5.10.4.2 Anatomy of the skull

[0769] Frontal Bone: The frontal bone includes a large vertical portion (the squama) that corresponds to the area called the forehead.

[0770] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0771] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye sockets. The frontal process of the maxilla projects upward from the sides of the nose and forms part of the lateral border.

[0772] Nasal bones: The nasal bones are two small, oval bones that vary in size and form among different individuals; they lie side by side in the middle and upper parts of the face and form the "bridge" of the nose at their junction.

[0773] Nasal root: The intersection of the frontal bone and the two nasal bones, the concave area directly between the eyes and on the upper part of the bridge of the nose.

[0774] Occipital bone: The occipital bone is located at the back and lower part of the skull. It contains the oval hole (foramen magnum) through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0775] Orbit: The bony cavity in the skull that houses the eyeball.

[0776] Parietal bones: The parietal bones are the bones that, when joined together, form the roof and sides of the skull.

[0777] Temporal bones: The temporal bones are located at the base and sides of the skull and support the part of the face called the temples.

[0778] Zygomatic bones: The face includes two zygomatic bones, which are located on the upper and side parts of the face and form the protrusions of the cheeks.

[0779] 5.10.4.3 Anatomy of the respiratory system

[0780] Diaphragm: A sheet of muscle that extends across the base of the rib cage. The diaphragm separates the thoracic cavity (which contains the heart, lungs, and ribs) from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0781] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0782] Lung: The respiratory organ of humans. The conducting zone of the lungs consists of the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone consists of the respiratory bronchioles, alveolar ducts, and alveoli.

[0783] Nasal Cavity: The nasal cavity (or nasal fossa) is a large, air-filled space in the middle of the face, above and behind the nose. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called the turbinates (singular "nasal conchae") or nasal conchae. The front of the nasal cavity is the nose, while the back connects to the nasopharynx via the internal nostrils.

[0784] Pharynx: The part of the throat located just below (underneath) the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (epipharynx) (the nasal portion of the pharynx), the oropharynx (mesopharynx) (the oral portion of the pharynx), and the hypopharynx (hypopharynx).

[0785] 5.10.5 Patient interface

[0786] Anti-Asphyxia Valve (AAV): A component or subcomponent of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to atmosphere in a fail-safe manner.

[0787] Elbow: An elbow is an example of a structure that redirects the axis of airflow traveling therethrough at an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater or less than 90 degrees. The elbow may have a cross-section that is approximately circular. In another form, the elbow may have an oval or rectangular cross-section. In some forms, the elbow may be rotatable relative to the mating component, for example, through approximately 360 degrees. In some forms, the elbow may be removable from the mating component, for example, via a snap connection. In some forms, the elbow may be assembled to the mating component during manufacturing via a disposable snap, but may not be removed by the patient.

[0788] Frame: The frame will be considered to mean the mask structure that carries the tensile load between two or more connection points to the headgear. A mask frame can be a non-airtight, load-bearing structure in the mask. However, some forms of mask frames can also be airtight.

[0789] Headgear: A headgear will be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, a headgear may include a collection of one or more supports, straps, and reinforcements configured to position and maintain a patient interface in position on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, resilient materials, such as laminated composites of foam and fabric.

[0790] Film: A film shall be taken to mean a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.

[0791] Pneumatic chamber: The mask pneumatic chamber will be understood to mean a portion of the patient interface having walls at least partially enclosing a volume of space that, in use, has air inflated therein to above atmospheric pressure. The housing may form part of the wall of the mask pneumatic chamber.

[0792] Seal: can be a noun referring to a structure ("seal") or a verb referring to that effect ("seal"). Two elements can be constructed and / or arranged to 'seal' or achieve a 'seal' between them without requiring a separate 'seal' element itself.

[0793] Shell: Shell will be understood to mean a curved, relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural wall of a mask can be the shell. In some forms, the shell can be multi-faceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0794] Reinforcement: A reinforcement will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0795] Bracing: Bracing will be taken to mean a structural component designed to increase the compression resistance of another component in at least one direction.

[0796] Swivel (noun): A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably comprises a pair of matching cylindrical conduits. There may be little or no air flow leakage from the swivel during use.

[0797] Tie (noun): A structure designed to resist tension.

[0798] Vent (noun): A structure that allows air flow from the interior of a mask or tube to the ambient air for clinically effective flushing of exhaled gases. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and the treatment pressure.

[0799] 5.10.6 Shape of the structure

[0800] Products according to the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or a thruster. The three-dimensional structures may be combined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe the relative surface orientation, position, function, or some other feature. For example, a structure may include one or more of a front surface, a back surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., underside or inner) surface. In another example, a structure may include a first surface and a second surface.

[0801] To help describe the shape of three-dimensional structures and surfaces, first consider a cross section through the surface of the structure at a point p. Figures 3B to 3F , they show examples of cross sections at a point p on the surface and the resulting plane curve. On the surface, the resulting plane is curved. Figures 3B to 3F Also illustrated is the outward normal vector at p. The outward normal vector at p away from the surface. In some examples, the surface is depicted from the point of view of an imaginary person standing upright on the surface.

[0802] 5.10.6.1 Curvature in One Dimension

[0803] The curvature of a planar curve at P can be described as having a sign (eg, positive, negative) and a magnitude (eg, the inverse of the radius of a circle that touches the curve only at P).

[0804] Positive curvature: If the curve turns toward the outward normal at p, then the curvature at that point will be positive (if an imaginary person leaves point p, they must be walking uphill). Figure 3B (and Figure 3C Compared with the relatively large positive curvature) and Figure 3C (and Figure 3B Such curves are often called concave.

[0805] Zero curvature: If the curve is a straight line at point p, then the curvature will be zero (if the imaginary person leaves point p, they can walk horizontally, neither up nor down). Figure 3D .

[0806] Negative curvature: If the curve at point p turns away from the outward normal, then the curvature in that direction at that point will be negative (if the imaginary person leaves point p, they must be walking downhill). Figure 3E (and Figure 3F Compared to the relatively small negative curvature) and Figure 3F (and Figure 3E Such curves are often called convex.

[0807] 5.10.6.2 Curvature of Two-Dimensional Surfaces

[0808] A description of the shape at a given point on a two-dimensional surface according to the present technology can include multiple normal cross-sections. The multiple cross-sections can cut the surface in a plane including the outward normal ("normal plane"), and each cross-section can be taken in a different direction. Each cross-section produces a planar curve with a corresponding curvature. The different curvatures at the point can have the same sign or different signs. Each curvature at the point has a magnitude, for example, a relatively small magnitude. Figures 3B to 3F The plane curve in can be an example of such multiple sections at specific points.

[0809] Principal curvature and direction: The normal directions along which the curvature of a curve takes its maximum and minimum values ​​are called principal directions. Figures 3B to 3F In the example, the maximum curvature occurs at Figure 3B The minimum curvature occurs in Figure 3F Therefore Figure 3B and Figure 3F is the cross section in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0810] Surface Region: A connected set of points on a surface. Points in a region can have similar characteristics, such as curvature or sign.

[0811] Saddle region: A region where at each point the principal curvatures have opposite signs, ie one sign is positive and the other negative (depending on the direction the imagined individual is turning, they can be walking up or down).

[0812] Dome region: The region where at every point the principal curvatures have the same sign, e.g. two positive ("concave dome") or two negative ("convex dome").

[0813] Cylindrical region: A region in which one of the principal curvatures is zero (or is zero within manufacturing tolerances, for example) and the other principal curvature is non-zero.

[0814] Planar region: A surface region where both principal curvatures are zero (or are zero within manufacturing tolerances, for example).

[0815] Surface edge: The boundary or limit of a surface or area.

[0816] Path: In some forms of this technology, 'path' will mean a path in the mathematical-topological sense, e.g., a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technology, a 'path' can be described as a route or course, comprising, for example, a set of points on a surface. (An imagined individual's path is one in which they walk on a surface and is similar to a garden path).

[0817] Path length: In some forms of this technology, 'path length' will be considered to mean the distance along the surface from f(0) to f(1), i.e., the distance along a path on the surface. There may be more than one path between two points on the surface and such paths may have different path lengths. (The path length of an imaginary individual would be the distance they walked along the path on the surface).

[0818] Straight-line distance: Straight-line distance is the distance between two points on a surface, but is independent of the surface. In a planar region, a path on the surface can have the same path length as the straight-line distance between two points on the surface. On a non-planar surface, a path with the same path length as the straight-line distance between two points can not exist. (For an imaginary individual, straight-line distance would correspond to a distance as a 'straight line'.)

[0819] 5.10.6.3 Space curve

[0820] Space curves: Unlike plane curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, i.e., have no endpoints. Space curves can be considered as one-dimensional segments of three-dimensional space. An imaginary person walking on one strand of a DNA helix walks along a space curve. A typical human left ear consists of a helix, which is a left-handed helix, see Figure 3QThe typical human right ear includes a helix that is a right-handed helix, see Figure 3R . Figure 3S A right-handed spiral is shown. The edge of a structure, such as a membrane or impeller, can follow a space curve. In general, a space curve can be described by the curvature and torsion at each point on the space curve. Torque is a measure of how the curve turns out of the plane. Torque has a sign and magnitude. The torsion at a point on a space curve can be characterized by reference to the tangent vector, normal vector, and binormal vector at that point.

[0821] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction from that point, as well as the magnitude. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If an imaginary person were flying along the curve and dropped from their aircraft at a specific point, the direction of the tangent vector would be the direction they would be traveling.

[0822] Unit Normal Vector: As an imaginary person moves along a curve, this tangent vector itself changes. The unit vector pointing in the direction of the tangent vector's change is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0823] 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 (e.g., see Figure 3P ) or optionally by the left-hand rule ( Figure 3O ) to confirm.

[0824] Sagittal plane: The plane containing the unit tangent vector and the unit principal normal vector. Figure 3O and 3P .

[0825] Torsion of a space curve: The torsion of a space curve at a point is the rate of change of the binormal unit vector at that point. It measures the degree to which the curve deviates from the sagittal plane. A space curve that lies within the plane has zero torsion. A space curve that deviates from the plane by a relatively small amount will have a relatively small amount of torsion (e.g., a gently inclined spiral path). A space curve that deviates from the sagittal plane by a relatively large amount will have a relatively large amount of torsion (e.g., a sharply inclined spiral path). See Figure 3S Since T2>T1, the twist near the top coil of the spiral in Figure 3 is greater than Figure 3S The amount of twist in the bottom coil of the helix.

[0826] Reference Figure 3P According to the right-hand rule, a space curve with a right-hand binormal can be considered to have a right-hand positive twist (e.g., Figure 3S A space curve that turns away from the right-handed binormal direction can be considered to have right-handed negative twist (e.g., a left-handed helix).

[0827] Likewise, referring to the left-hand rule (see Figure 3O ), a space curve oriented in the direction of the left-handed binormal can be considered to have a left-handed positive twist (e.g., a left-handed helix). Thus left-handed positive is equivalent to right-handed negative. See Figure 3T .

[0828] 5.10.6.4 Holes

[0829] A surface can have one-dimensional pores, for example, pores defined by a planar curve or a spatial curve. A thin structure (e.g., a membrane) having pores can be described as having one-dimensional pores. See, for example, Figure 3I A one-dimensional hole in the surface of the structure shown is bounded by a planar curve.

[0830] A structure can have a two-dimensional aperture, such as a aperture defined by a surface. For example, an inflatable tire has a two-dimensional aperture defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have a two-dimensional aperture. See, for example, Figure 3L The padding and the Figure 3M and Figure 3N , showing an exemplary cross-section of a conduit defining a two-dimensional aperture. In yet another example, a conduit can include a one-dimensional aperture (e.g., at its inlet or at its outlet) and a two-dimensional aperture defined by the conduit's inner surface. See also Figure 3K A two-dimensional hole in the shown structure is bounded by the shown surface.

[0831] 5.11 Other Notes

[0832] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent Office file or records, but otherwise reserves all copyright rights whatsoever.

[0833] Unless the context clearly indicates otherwise and a numerical range is provided, it is understood that each intervening value between the upper and lower limits of the range, to the tenth of the unit of the lower limit, and any other stated or intervening value in that stated range are broadly encompassed within the present technology. The upper and lower limits of these intermediate ranges may independently be included in the intermediate ranges and are also encompassed within the present technology, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the stated limits, ranges excluding either or both of those included limits are also encompassed within the present technology.

[0834] Furthermore, where a value or values ​​are described herein for implementation as part of the present technology, it should be understood that such values ​​may be approximate unless otherwise indicated, and that such values ​​may be used to any appropriate number of significant digits to the extent permitted or required by practical technical implementation.

[0835] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0836] When a particular material is identified as being used to construct a component, obvious alternative materials having similar properties may be used as substitutes. Furthermore, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus may be manufactured together or separately.

[0837] It must be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural equivalents unless the context clearly dictates otherwise.

[0838] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosures prior to the filing date of the present application. This paper should not be construed as admitting that the present technology is not entitled to disclose earlier than this type of disclosure due to prior invention. In addition, the publication date provided may be different from the actual publication date, which may require independent confirmation.

[0839] The terms “include” and “comprising” should be interpreted as meaning that the referenced elements, components or steps may be present, used or combined with other elements, components or steps that are not explicitly referenced in a non-exclusive manner.

[0840] The subject headings used in the detailed description are for the convenience of the reader and should not be used to limit the subject matter that can be found in the entire disclosure or claims. The subject headings should not be used to interpret the scope of the claims or claim limitations.

[0841] Although the technology herein has been described with reference to specific examples, it should be understood that these examples only illustrate the principles and applications of the technology. In some cases, terms and symbols may imply specific details that are not required for practical use of the technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to represent any order, but may be used to distinguish different elements. In addition, although the process steps in the method can be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects thereof can be performed simultaneously or even synchronously.

[0842] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology.

Claims

1. A positioning and stabilizing structure for a patient interface, comprising: forming a front section and a rear section of a continuous loop of material, the front section forming a first bifurcated section having a first portion and a second portion; an upper fabric portion comprising an elastic circumferential band for fitting to a patient's head in use, said upper fabric portion being formed by said rear section and said first portion; as well as at least one lower fabric portion formed from the second portion and movably connected to the upper fabric portion; wherein at least one first lower fabric portion of the at least one lower fabric portion is stretchable relative to the upper fabric portion and is constructed and arranged to provide a force to maintain a seal-forming structure of the patient interface in a therapeutically effective position on the patient's head; wherein the front section bifurcates into the first lower fabric portion and the upper fabric portion at a pair of bifurcation points, and When the patient wears the positioning and stabilizing structure, the first lower fabric portion is configured to be movable between 1) a first position and 2) a second position, wherein in the first position, the first lower fabric portion covers the patient's forehead and is in close proximity to the upper fabric portion at least along the portion of the front section between the bifurcation points, and in the second position, the first lower fabric portion covers the patient's cheek and is spaced apart from the upper fabric portion.

2. The positioning and stabilising structure of claim 1, wherein the first lower fabric portion is integral with the upper fabric portion.

3. The positioning and stabilising structure of claim 1 , wherein the positioning and stabilising structure is in the form of a headband.

4. The positioning and stabilizing structure of claim 3, wherein the rear section of the headband includes a second bifurcated section, the second bifurcated section including the second portion of the upper fabric portion and further including a second lower fabric portion.

5. The positioning and stabilizing structure of claim 4 , wherein the second portion of the upper fabric portion and the second lower fabric portion are configured to cover the patient's occipital bone in the first position, and wherein the second portion of the upper fabric portion is movable away from the second lower fabric portion to cover the parietal bone in the second position.

6. The positioning and stabilizing structure of claim 4, wherein the front section and the rear section combine to form an X-shape in the second position.

7. A positioning and stabilizing structure according to claim 1, wherein the first lower fabric portion is a sealing retention band, which is elastically stretchable along at least a portion of its length and is suitable for engaging with the outer surface of the patient interface to maintain the sealing forming structure in the therapeutically effective position.

8. A positioning and stabilising structure according to claim 7, wherein the seal retention strip is more stretchable than the upper fabric portion.

9. A positioning and stabilising structure according to claim 7, wherein the seal retention strip is adapted to be received in a channel of the patient interface.

10. A positioning and stabilising structure according to claim 9, wherein the channel is formed in a pneumatic chamber of the patient interface.

11. The positioning and stabilizing structure of claim 7, wherein the seal-retaining band includes a port for coupling the seal-forming structure to an air circuit for supplying pressurized air to the patient.

12. A positioning and stabilising structure according to claim 1, comprising a pair of lower fabric portions adapted to be coupled to each other and / or to an intermediate structure to provide said force.

13. A positioning and stabilising structure according to claim 12, wherein the intermediate structure is a harness for retaining the seal-forming structure in the therapeutically effective position during use.

14. A positioning and stabilising structure according to claim 12, wherein the intermediate structure comprises the seal-forming structure or a portion thereof.

15. The positioning and stabilising structure of claim 1, wherein at least one of the lower fabric portions comprises one or more rigidised sections.

16. A positioning and stabilising structure according to claim 15, wherein said at least one lower fabric portion is stiffer in a mid-section thereof than at its ends.

17. A positioning and stabilising structure according to claim 1, comprising at least one sensor arranged in or on the upper fabric portion and / or one or more lower fabric portions.

18. Positioning and stabilising structure according to claim 17, comprising at least one actuator arranged in or on the upper fabric portion and / or one or more lower fabric portions.

19. A positioning and stabilizing structure according to claim 18, wherein the at least one sensor and / or the at least one actuator are partially exposed to the surrounding environment at the outer surface of the upper fabric part or the one or more lower fabric parts; and / or are partially exposed at the patient contact surface of the upper fabric part or the one or more lower fabric parts so as to contact the patient's skin during use.

20. The positioning and stabilising structure of claim 18, wherein the at least one sensor and / or the at least one actuator are at least partially embedded between an outer layer of the upper textile portion or one or more lower textile portions and a patient contacting layer.

21. The positioning and stabilizing structure of claim 18, wherein the at least one sensor and / or the at least one actuator comprises an electrical circuit formed at least in part by one or more conductive wires and / or one or more conductive ink traces.

22. The positioning and stabilising structure of claim 18, comprising at least one sensor holding structure for attaching the at least one sensor and / or a corresponding sensor in the at least one actuator.

23. The positioning and stabilising structure of claim 22, wherein the at least one sensor holding structure comprises at least one pocket to accommodate the at least one sensor and / or the at least one actuator.

24. The positioning and stabilizing structure according to claim 18, comprising a wireless communication interface for sending data from the at least one sensor to one or more external computing devices and / or for receiving data from the one or more external computing devices at the at least one actuator.

25. The positioning and stabilizing structure of claim 18, wherein the at least one sensor and / or the at least one actuator comprises one or more of: an accelerometer; a gyroscope; a humidity sensor; a temperature sensor; a microphone; a camera; a pulse oximeter; an EEG sensor; an EMG sensor; an EOG sensor; a touch sensor; a vibration device; and an audio output device.

26. A patient interface comprising: a pneumatic chamber capable of being pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the pneumatic chamber comprising a pneumatic chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for patient breathing, a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that a flow of air at the treatment pressure is delivered at least to the entrance of the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the treatment pressure in the pneumatic chamber throughout the patient's breathing cycle, A positioning and stabilising structure according to any one of claims 1 to 25, the positioning and stabilising structure being configured to provide a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head.

27. A patient interface according to claim 26, wherein the first lower fabric portion is a seal retention strap, which is elastically stretchable along at least a portion of its length and is configured to engage with the outer surface of the pneumatic chamber or the seal-forming structure to maintain the seal-forming structure in the therapeutically effective position.

28. A patient interface according to claim 27, wherein the seal retention strip is received in a channel of the patient interface.

29. A patient interface according to claim 28, wherein the channel is formed in an outer surface of the pneumatic chamber.

30. A patient interface according to claim 27, wherein the seal retention band includes a port for connecting the pneumatic chamber inlet port to an air circuit for supplying pressurized air to the patient.

31. A patient interface according to claim 26, wherein the intermediate structure of the positioning and stabilising structure is a harness which, in use, engages with an outer surface of the pneumatic chamber or with an outer surface of the seal-forming structure.

32. A patient interface according to claim 31 , wherein the intermediate structure comprises the pneumatic chamber and / or the seal-forming structure or a portion thereof.

33. A patient interface according to claim 26, wherein the at least one lower fabric portion comprises at least one pair of lower fabric portions, the at least one pair of lower fabric portions comprising one or more rigidified portions.

34. The patient interface of claim 26, further comprising at least one sensor disposed in or on the upper fabric portion, and / or at least one of the pair of lower fabric portions, and / or the pneumatic chamber, and / or the seal-forming structure.

35. The patient interface according to claim 34 further comprises at least one actuator, which is arranged in or on the upper fabric portion, and / or the at least one pair of lower fabric portions, and / or the pneumatic chamber, and / or the seal-forming structure.

36. A patient interface according to claim 35, wherein the at least one sensor and / or the at least one actuator comprises one or more of: an accelerometer; a gyroscope; a humidity sensor; a temperature sensor; a microphone; a camera; a pulse oximeter; an EEG sensor; an EMG sensor; an EOG sensor; a touch sensor; a pressure sensor; a CO2 sensor; a vibration device; and an audio output device.

37. A patient interface according to claim 36, wherein the at least one sensor comprises at least one pressure sensor in fluid communication with the pneumatic chamber.

38. A patient interface according to claim 26, wherein the pneumatic chamber includes a housing and has an inner housing surface and an outer housing surface, and wherein the inner housing surface is configured to be at the treatment pressure in use and the outer housing surface is configured to be at the ambient pressure in use.

39. A patient interface according to claim 38, wherein the at least one lower fabric portion engages at least a portion of the outer surface of the housing to maintain the seal-forming structure in the therapeutically effective position.

40. A patient interface according to claim 39, wherein The first lower fabric portion is a seal retention band that is elastically stretchable along at least a portion of its length and is configured to engage with an outer surface of the pneumatic chamber or the seal-forming structure to maintain the seal-forming structure in the therapeutically effective position, wherein the seal retention band is received in a channel of the patient interface and wherein the channel is formed in the outer surface of the shell.

41. A patient interface according to claim 38, wherein the housing is constructed of a hard plastic material.

42. A patient interface according to claim 38, wherein the housing is semi-rigid and / or elastic.

43. A patient interface according to claim 38, wherein the housing is constructed of a transparent material.

44. A patient interface according to claim 38, wherein the housing is coupled to the seal-forming structure.

Images