Patient interface, and positioning and stabilising structure for patient interface

Abstract

To provide a positioning and stabilising structure for a patient interface.SOLUTION: A positioning and stabilising structure for a patient interface comprises a headband which is formed at least partly from a textile material and has an upper textile portion movably connected to a first lower textile portion, the headband comprising one or more sensors provided in or on the upper textile portion and / or the first lower textile portion. The headband is wearable on a patient's head in a first configuration in which the first lower textile portion is adjacent to the upper textile portion and a second configuration in which the first lower textile portion is separated from the upper textile portion and provides a force to hold a seal-forming structure of the patient interface at a therapeutically effective position on the patient's head.SELECTED DRAWING: Figure 4B

Description

[Technical Field]

[0001] 1 Cross-reference to related applications This application claims the benefit of Singapore Patent Application No. 10202006315, filed on June 30, 2020, the entire contents of which are incorporated by reference. [Background technology]

[0002] 2. Technical Background 2.1 Technology field The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatus and uses thereof. 2.2 Description of Related Art 2.2.1 The human respiratory system and its diseases

[0003] The body's respiratory system facilitates gas exchange. The nose and oral cavity form the entrance to a patient's airways.

[0004] These airways comprise a series of branching tubes that become narrower, shorter, and more numerous the deeper they go into the lungs. The lungs' primary function is gas exchange, allowing oxygen to enter the venous blood from the air and carbon dioxide to leave. The trachea divides into the right and left main bronchi, which further divide into the terminal bronchioles. The bronchi constitute the conducting airways and are not involved in gas exchange. The airways further divide into the respiratory bronchioles and ultimately the alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory zone. See, e.g., (Non-Patent Document 1).

[0005] A range of respiratory diseases exists, and particular diseases can be characterized by particular episodes (e.g., apnea, hypopnea, and hyperpnea).

[0006] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall diseases.

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes of upper airway closure or obstruction during sleep. This is the result of an abnormally small upper airway combined with a normal loss of muscle tone in the tongue, soft palate, and posterior oropharyngeal wall region during sleep. This condition causes affected individuals to pause breathing, typically for 30 to 120 seconds, sometimes 200 to 300 times per night. This can result in excessive daytime sleepiness, which can contribute to cardiovascular disease and brain damage. This condition is common, particularly among middle-aged, overweight men, but patients often experience no symptoms. See U.S. Pat. No. 4,944,310 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory control in which rhythmic alternating periods of increased and decreased ventilation, known as CSR cycles, are present. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with recurrent sleep arousals, which can cause severe insomnia, increased sympathetic nervous activity, and increased afterload. See U.S. Patent No. 5,929,499 (Berthon-Jones).

[0009] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following disorders:

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

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

[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics, including increased resistance to air movement, prolonged expiratory phase of breathing, and a decrease in normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0013] Neuromuscular disease (NMD) is a broad term encompassing numerous diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle impairment, resulting in the inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be categorized as rapidly progressive or slowly progressive: (i) rapidly progressive disorders, characterized by muscle impairment that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders, characterized by muscle impairment that worsens over years and only modestly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophies). Symptoms of respiratory failure in NMD include: increasing general weakness, difficulty swallowing, difficulty breathing on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0014] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive obstruction and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can lead to severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0015] A range of treatments are available to treat or ameliorate these conditions, and preventative treatments for respiratory disease are also available to benefit otherwise healthy individuals. However, these suffer from several deficiencies. 2.2.2 Therapy

[0016] A variety of respiratory therapies (e.g., continuous positive airway pressure (CPAP) therapy, noninvasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) are used to treat one or more of the above-mentioned respiratory disorders. 2.2.2.1 Respiratory pressure therapy

[0017] Respiratory pressure therapy is the application of air supply to the entrance of the airways at a controlled target pressure that is nominally positive relative to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapies such as tank ventilators or cuirasses).

[0018] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that CPAP therapy acts as a pneumatic splint, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, thereby preventing closure of the upper airway. Because treatment of OSA with CPAP therapy can be voluntary, patients may choose not to adhere to treatment if they perceive one or more of the following about the device used to deliver treatment: it is uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0019] Noninvasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist the patient in breathing and / or maintain adequate oxygen levels in the body by performing some or all of the respiratory functions. Ventilatory support is provided through a noninvasive patient interface. NIV is used to treat CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0020] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments may be improved. 2.2.2.2 Flow Therapy

[0021] Not all respiratory therapies are intended to deliver a prescribed therapeutic pressure. Some respiratory therapies aim to deliver a prescribed respiratory volume by delivering an inspiratory flow profile (perhaps superimposed on a positive baseline pressure) for a targeted duration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy with a flow of conditioned or concentrated gas may be used only to support the patient's spontaneous breathing. In one example, high-flow therapy (HFT) involves providing a continuous, heated, humidified airflow through an unsealed or open patient interface to the airway entrance at a "therapeutic flow" that remains nearly constant throughout the respiratory cycle. The therapeutic 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. One mechanism of action is that providing a high flow of air to the airway entrance improves ventilation efficiency by allowing the patient's anatomical dead space to be washed away or flushed with exhaled CO2. Therefore, HFT is sometimes referred to as dead space therapy (DST). Other benefits may include improved warmth and humidification (possibly through the benefit of secretory control) and a gradual increase in airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate may follow a profile that varies over the respiratory cycle.

[0022] Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy, in which a physician may prescribe a continuous flow of oxygen-enriched air at a specified oxygen concentration (between 21% and 100% of the oxygen fraction in ambient air) to be delivered to a patient's airways at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, or 3 LPM). 2.2.2.3 Supplemental oxygen

[0023] For certain patients, a combination of oxygen therapy and respiratory pressure therapy or HFT can be achieved by adding supplemental oxygen to the pressurized air stream. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is referred to as HFT with supplemental oxygen. 2.2.3 Respiratory Treatment Systems

[0024] These respiratory therapies may be provided by respiratory treatment systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor disease without treating it.

[0025] The respiratory treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management. 2.2.3.1 Patient Interface

[0026] A patient interface may be used to provide a wearer with an interface to a respiratory appliance, for example, by providing airflow to the airway entrance. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy being applied, the patient interface may form a seal with, for example, an area of ​​the patient's face, thereby facilitating gas delivery at a pressure with sufficient dispersion (e.g., at a positive pressure of about 10 cmH2O relative to atmospheric pressure) with ambient pressure for therapy implementation. In other forms of therapy, such as oxygen delivery, the patient interface may not include a sufficient seal to facilitate delivery of a gas supply to the airways at a positive pressure of about 10 cmH2O. In the case of flow therapy, such as nasal HFT, the patient interface is configured to insufflate the nares (and specifically avoid a complete seal). One example of such a patient interface is a nasal cannula.

[0027] Certain other mask systems may be functionally inadequate in this field. For example, masks intended for purely decorative purposes may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures and not maintain internal air at pressures higher than ambient.

[0028] Certain masks may be clinically unsuitable for this technology (for example, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0029] In certain masks, the patient must insert part of the mask structure into their mouth and create and maintain a seal via their lips, which may be uncomfortable or impractical in this technology.

[0030] Certain masks may be impractical for use while sleeping (eg, when sleeping on your side in bed with your head resting on a pillow).

[0031] There are multiple challenges in designing a patient interface. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. That is, the chin or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory treatment period.

[0032] These challenges can lead to one or more of the following: some masks can be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if worn for extended periods or if the patient is unfamiliar with the system. If the wrong size mask is used, this can lead to reduced compliance, reduced comfort, and poor patient outcomes. While masks specifically designed for aviators, personal protective equipment (e.g., filter masks), SCUBA masks, or anesthesia administration masks may be durable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods (e.g., several hours). Such discomfort can reduce patient compliance with treatment. This is especially true if the mask must be worn while sleeping.

[0033] CPAP therapy is highly effective in treating certain respiratory conditions when patients comply with the therapy. However, if the mask is uncomfortable or difficult to use, patients may not comply. Patients are often encouraged to clean their masks regularly, but if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean the mask, which may affect patient compliance.

[0034] Masks for other uses (e.g., aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

[0035] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field. 2.2.3.1.1 Seal-forming structure

[0036] The patient interface may include a seal-forming structure. Because the patient interface is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may have a direct impact on the effectiveness and comfort of the patient interface.

[0037] Patient interfaces can be characterized in part according to the design intent of where the seal-forming structure engages with the face during use. In one form of patient interface, the seal-forming structure can include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nostrils during use. Such a single element can be designed, for example, to rest on the upper lip region and nose bridge region of the face. In one form of patient interface, the seal-forming structure can include an element that surrounds the oral cavity region during use, for example, by forming a seal on the lower lip region of the face. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces can be known by various names depending on their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0038] A seal-forming structure that may be effective in one area of ​​a patient's face may be inappropriate in another area due to, for example, different shapes, structures, variability, and sensitive areas of the patient's face. For example, the sealing portion of swim goggles that rests on the patient's forehead may be inappropriate for use on the patient's nose.

[0039] A particular seal-forming structure can be designed for mass production so that one design is compatible, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-manufactured patient interface, one or both must be adapted to form the seal.

[0040] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure engaging against the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or may include a molded or formed surface of a resilient sealing element constructed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will form between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0041] Another type of seal-forming structure uses a thin flap seal positioned around the periphery of the mask to provide a self-sealing seal against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming portion, poor fit between the face and mask can require additional force to achieve a seal or cause the mask to leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming portion can fold or buckle during use, causing leakage.

[0042] Other types of seal-forming structures may include friction-fit elements that are inserted into the nostrils, for example, but some patients find these seal-forming parts uncomfortable.

[0043] Another form of seal-forming structure may use adhesives to achieve a seal, as some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0044] A range of patient interface seal forming structures are disclosed in the following patent applications (assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

[0045] One form of nasal pillow is found in the Adam line manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0046] ResMed Limited manufactures the following products that use nasal pillows: SWIFT® Nasal Pillows Mask, SWIFT® II Nasal Pillows Mask, SWIFT® LT Nasal Pillows Mask, SWIFT® FX Nasal Pillows Mask, and MIRAGE LIBERTY® Full Face Mask. Embodiments of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: International Patent Application No. WO 2004 / 073,778 (which describes, among other things, aspects of ResMed Limited's SWIFT® Nasal Pillows); U.S. Patent Application No. 2009 / 0044808 (which describes, among other things, aspects of ResMed Limited's SWIFT® LT Nasal Pillows); International Patent Applications Nos. WO 2005 / 063,328 and WO 2006 / 130,903 (which describe, among other things, aspects of ResMed Limited's MIRAGE LIBERTY® Full Face Mask); and International Patent Application No. WO 2009 / 052,560 (which describes, among other things, aspects of ResMed Limited's SWIFT® FX Nasal Pillows). 2.2.3.1.2 Positioning and stabilization

[0047] The seal-forming structures of patient interfaces used in positive air pressure therapy are subjected to corresponding forces of air pressure that disrupt the seal, and therefore a variety of techniques are used to position the seal-forming structures and maintain a seal against the appropriate portion of the face.

[0048] One technique involves the use of adhesives, see, for example, U.S. Patent Application Publication No. US2010 / 0000534, but adhesives can be uncomfortable.

[0049] Another technique involves the use of one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following problems: poor fit, bulky, uncomfortable, and cumbersome.

[0050] A further difficulty with known positioning and stabilization arrangements for respiratory therapy is that they can be complicated for a patient to attach and correctly position on their head for effective treatment. Additionally, for someone new to respiratory therapy, wearing an unfamiliar device that may cover a large portion of the head can be an unfamiliar and confronting experience, which may discourage patient compliance. 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0051] Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to deliver one or more of the therapies described above, for example, by activating the device to generate an air delivery flow to an interface with the airway. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). As such, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0052] Air pressure generators are known for a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical applications have specific requirements that cannot be met by more common air pressure generators (e.g., the reliability, size, and weight requirements of medical equipment). In addition, even devices designed for medical treatment may suffer from deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0053] One example of a special requirement for a particular RPT device is acoustic noise.

[0054] Table of noise output levels of conventional RPT devices (measured on one sample only at 10cmH2O in CPAP mode using the test method specified in ISO3744).

[0055] [Table 1]

[0056] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can provide invasive and non-invasive independent respiratory support for patients for a range of conditions, including, but not limited to, NMD, OHS, and COPD.

[0057] The ResMed Elisee® 150 ventilator and ResMed VSIII® ventilators can provide invasive and non-invasive dependent respiratory support suitable for adult or pediatric patients for the treatment of multiple conditions. These ventilators offer volumetric and pressure ventilation modes using single or dual limb circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) and are configured to deliver airflow to the patient's airway. In some cases, the airflow can be delivered to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface, as described above.

[0058] A device designer may be presented with a myriad of choices. Often, conflicting design criteria may make certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular implementation may be significantly affected by minor changes in one or more parameters. 2.2.3.3 Air Circuit

[0059] An air circuit is a conduit or tube constructed and arranged so that, in use, airflow travels between two components of a respiratory therapy system (e.g., an RPT device and a patient interface). In some cases, there may be separate limbs of the air circuit for inspiration and expiration. In other cases, a single limb air circuit is used for both inspiration and expiration. 2.2.3.4 Humidifier

[0060] Delivery of airflow without humidification can lead to dryness of the airway. When a humidifier is used with an RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort of the patient's airway. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air.

[0061] A range of artificial humidification devices and systems are known, but do not meet the special requirements of medical humidifiers.

[0062] Medical humidifiers are typically used when a patient is sleeping or resting (e.g., in a hospital) to increase the humidity and / or temperature of an air stream relative to the ambient air when needed. Bedside medical humidifiers may be compact. Medical humidifiers may be configured to only humidify and / or heat the air stream delivered to the patient, not the patient's surroundings. For example, while room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed into the patient's body, these systems also humidify and / or heat the entire room, which may be uncomfortable for occupants. Additionally, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0063] Although many medical humidifiers are known, such medical humidifiers may suffer from one or more deficiencies, such that some provide inadequate humidification or are difficult or inconvenient for the patient to use. 2.2.3.5 Oxygen Source

[0064] Experts in the field recognize that exercise for patients with respiratory failure can provide long-term benefits, slowing disease progression, improving quality of life, and extending the patient's lifespan. However, many stationary forms of exercise, such as treadmills and exercise bikes, are too strenuous for these patients. As a result, the need for mobility has long been recognized. Until recently, this mobility has been facilitated by the use of small compressed oxygen tanks or cylinders mounted on carts with trolley wheels. The drawbacks of these tanks are that they contain a limited amount of oxygen and are heavy, weighing approximately 50 pounds when attached.

[0065] Oxygen concentrators have been used to provide oxygen for respiratory therapy for approximately 50 years. Traditional oxygen concentrators are bulky and heavy, making normal ambulatory activities difficult and impractical. Recently, companies that manufacture large stationary oxygen concentrators have begun developing portable oxygen concentrators (POCs). The advantage of POCs is that they can generate a theoretically infinite supply of oxygen. To make these devices small enough to be portable, the various systems required to generate oxygen-enriched gas are condensed. POCs attempt to utilize the generated oxygen as efficiently as possible to minimize weight, size, and power consumption. This can be achieved by delivering oxygen as a series of pulses, or "boluses," with each bolus timed to coincide with the start of inhalation. This mode of therapy is known as pulsed oxygen delivery (POD) or demand mode, as opposed to traditional continuous-flow delivery, which is more suited to stationary oxygen concentrators. 2.2.3.6 Data Management

[0066] For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant," e.g., whether the patient adheres to one or more "compliance rules" for their RPT device. An example compliance rule for CPAP treatment may require a patient to use the RPT device for at least four hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

[0067] There may be other aspects of patient treatment that benefit from communication of treatment data to third parties or external systems. For example, it may be useful to have performance data, such as data indicating the effect of treatment on the patient and / or data indicating the functionality of the patient interface, allowing greater control over the treatment.

[0068] Existing processes for communicating and managing such data can be costly, time consuming, and / or error prone. 2.2.3.7 Ventilation technology

[0069] Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., ambient).

[0070] The vent may include an orifice through which gas can flow when the mask is in use. Many such vents are noisy. Others may become blocked during use, resulting in insufficient pumping. Some vents may disrupt sleep for the patient 1000 and bed companion 1100, for example, due to noise or concentrated airflow.

[0071] ResMed Limited has developed several improved mask ventilation technologies, see International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0072] Conventional mask noise table (ISO17510-2:2007, 10cmH2O pressure at 1m)

[0073] [Table 2]

[0074] (*Measured using only one sample at 10cmH2O in CPAP mode using the test method specified in ISO3744)

[0075] The sound pressure values ​​of various objects are listed below

[0076] [Table 3]

[0077] 2.2.4 Screening, diagnostic, and surveillance systems

[0078] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, but it typically requires specialized clinical staff for system application. PSG typically involves placing 15–20 contact sensors on the patient to record various body signals (e.g., electroencephalography (EEG), electrocardiogram (ECG), electrooculogram (EOG), and electromyography (EMG)). PSG for sleep-disordered breathing requires patients to be observed for two nights at a specialized hospital: the first night for pure diagnosis and the second night for clinician-directed titration of treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it requires complex equipment that is difficult or even impossible for patients to properly install for proper evaluation, making it unsuitable for home screening, diagnosis, and monitoring of sleep-disordered breathing.

[0079] In general, screening and diagnosis involve identifying disease through signs and symptoms. Screening typically produces a true / false result indicating whether a patient's SDB warrants further investigation, while diagnosis often produces clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the progression of disease can continue indefinitely. Some screening / diagnostic systems are only suitable for screening / diagnosis, while some can also be used for monitoring.

[0080] A clinical expert may adequately screen, diagnose, or monitor a patient based on visual observation of the PSG signal. However, there are situations where a clinical expert is not available or cannot be paid for. Different clinical experts may have different opinions about a patient's condition. Furthermore, some clinical experts may apply different criteria at different times. [Prior art documents] [Patent documents]

[0081] [Patent Document 1] U.S. Patent No. 6,532,959 [Non-patent literature]

[0082] [Non-Patent Document 1] “Respiratory Physiology”, by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012. ” Summary of the Invention [Means for solving the problem]

[0083] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory diseases, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0084] A first aspect of the present technology relates to a device for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disease.

[0085] Another aspect of the present technology relates to methods used to screen for, diagnose, monitor, ameliorate, treat or prevent respiratory disorders.

[0086] An aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.

[0087] One form of the present technology includes a patient interface that includes: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; 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 airways, said seal-forming structure having holes therein so that a flow of air at said therapeutic pressure is delivered to at least the entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle; A positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0088] One form of the present technology includes a positioning and stabilizing structure for a patient interface that is convertible between a first, pre-treatment configuration that may be worn by the patient as a headband, and a second configuration that may be used to apply force to maintain the seal-forming structure in position on the patient's face for effective respiratory therapy.

[0089] Another form of the present technology includes a patient interface having one or more sensors embedded, attached, or otherwise positioned therein and / or thereon to measure patient and / or device-related data for screening, monitoring, and / or diagnostic purposes.

[0090] One form of the present technology involves a positioning and stabilizing structure for a patient interface including: an upper fabric portion including a resilient circumferential band for fitting to a patient's head in use, and at least one lower fabric portion movably (e.g., hingedly) connected to the upper fabric portion, wherein at least a first lower fabric portion is stretchable relative to the upper fabric portion and constructed and arranged to provide a force that holds the seal-forming structure of the patient interface in a therapeutically effective position on the patient's head.

[0091] One form of the present technology includes a patient interface that includes: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; 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 airways, said seal-forming structure having holes therein so that a flow of air at said therapeutic pressure is delivered to at least the entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle; A positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. wherein the positioning and stabilizing structure comprises: an upper fabric portion including an elastic circumferential band for fitting to the patient's head during use; and at least one lower fabric portion movably connected to the upper fabric portion. Also herein, at least a first lower fabric portion is constructed and arranged to be stretchable relative to the upper fabric portion and to provide a force to hold the seal-forming structure of the patient interface in a therapeutically effective position on the patient's head.

[0092] One form of the present technology involves a positioning and stabilizing structure for a patient interface including: anterior and posterior sections forming a continuous loop of material, the anterior section forming a first bifurcated section having a first portion and a second portion; an upper fabric portion formed from the posterior section and the first portion and including a resilient circumferential band for fitting to a patient's head in use; and at least one lower fabric portion movably connected to the upper fabric portion, wherein the at least first lower fabric portion is stretchable relative to the upper fabric portion and constructed and arranged to provide a force to hold the seal-forming structure of the patient interface in a therapeutically effective position on the patient's head, and wherein the first lower fabric portion is movable between a first position and a second position, configured to rest on the patient's frontal bone at a first position proximal to the first portion and configured to rest on the patient's cheek at a second position distal to the first portion.

[0093] One form of the present technology includes a patient interface that includes: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; 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 airways, said seal-forming structure having holes therein so that a flow of air at said therapeutic pressure is delivered to at least the entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle; A positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. wherein the positioning and stabilizing structure comprises: a front section and a rear section forming a continuous loop of material, the front section forming a first branch section having a first portion and a second portion; an upper fabric portion including a resilient circumferential band for fitting to a patient's head in use, the upper fabric portion being formed from the rear section and the first portion; and at least one lower fabric portion movably connected to the upper fabric portion. Also herein, at least a first of the at least one lower fabric portion is constructed and arranged to be stretchable relative to the upper fabric portion and to provide a force to hold the seal-forming structure of the patient interface in a therapeutically effective position on the patient's head. Also herein, the first lower fiber portion is movable between a first position and a second position and configured to rest on the patient's frontal bone at the first position proximal to the first portion and configured to rest on the patient's cheek at the second position distal to the first portion.

[0094] In examples of the foregoing embodiments, (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 portion of the upper fabric portion, further includes a first lower fabric portion, and includes a first bifurcated section located at a front portion of the headband; (d) the headband includes a second portion of the upper fabric portion, further includes a second lower fabric portion, and includes a second bifurcated section located at a rear portion of the headband; (e) the first lower fabric portion is a resiliently stretchable seal retaining band along at least a portion of its length and adapted to engage an outer surface of a patient interface to retain the seal-forming structure in a therapeutically effective position; (f) the seal retaining band is more stretchable than the upper fabric portion, and the seal retaining band is adapted to be received in a channel of the patient interface; (g) the channel is formed in a plenum chamber of the patient interface; and / or (h) the seal retaining band includes a port for coupling the seal-forming structure to an air circuit for supplying pressurized air to the patient.

[0095] In examples of the foregoing embodiments, (a) the positioning and stabilizing structure comprises a pair of lower fabric portions adapted to couple to each other and / or to couple to the intermediate structure to provide force; (b) the intermediate structure is a harness that holds the seal-forming structure in a therapeutically effective position in use; (c) the intermediate structure comprises 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 resilient hooks or straps.

[0096] In examples of the foregoing embodiments, (a) at least one lower fabric portion includes one or more stiff sections, and / or (b) at least one lower fabric portion has a higher stiffness in its middle section than at its ends.

[0097] In examples of the aforementioned embodiments, (a) the positioning and stabilizing structure includes one or more sensors disposed in or on the upper textile portion and / or one or more lower textile portions; (b) the positioning and stabilizing structure includes one or more actuators disposed in or on the upper textile portion and / or one or more lower textile portions; (c) the at least one sensor or the at least one actuator is partially exposed to the environment on an outer surface of the upper textile portion or one or more lower textile portions, or partially exposed on a patient-contacting surface of the upper textile portion or one or more lower textile portions so as to contact the patient's skin in use; (d) the at least one sensor or the at least one actuator is 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; and (e) the at least one sensor and / or the at least one actuator is formed by one or more conductive yarns and / or one or more conductive inks. (f) the positioning and stabilizing structure includes one or more sensor holding structures for mounting each one of the sensors and / or actuators; (g) the one or more sensor holding structures include one or more pockets for accommodating one or more respective sensors or actuators; (h) the positioning and stabilizing structure includes a wireless communication interface for transmitting data from the one or more sensors to one or more external computing devices and / or 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 the 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.

[0098] In examples of the foregoing embodiments, (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 portion of the upper fabric portion, further includes a first lower fabric portion, and includes a first bifurcated section located at a front portion of the headband; (d) the headband includes a second portion of the upper fabric portion, further includes a second lower fabric portion, and includes a second bifurcated section located at a rear portion of the headband; (e) the first lower fabric portion is a resiliently stretchable seal retaining band along at least a portion of its length and adapted to engage an outer surface of the plenum chamber or the seal-forming structure to retain the seal-forming structure in a therapeutically effective position; (f) the seal retaining band is more stretchable than the upper fabric portion; (g) the seal retaining band is received in a channel of a patient interface; (h) the channel is formed in the outer surface of the plenum chamber; and / or (i) the seal retaining band includes a port for coupling the plenum chamber inlet port to an air circuit for supplying pressurized air to the patient.

[0099] In examples of the aforementioned embodiments, (a) the positioning and stabilizing structure includes a pair of lower fabric portions adapted to couple to each other or to the intermediate structure to provide force; (b) the intermediate structure is a harness that, in use, engages with the outer surface of the plenum chamber or the outer surface of the seal-forming structure; (c) the intermediate structure includes the plenum chamber and / or the seal-forming structure, or a portion thereof; (d) the plenum chamber and / or the seal-forming structure includes one or more protrusions or recesses for coupling to resilient hooks located on the lower fabric portions; (e) the lower fabric portions are coupled to each other and / or to the intermediate structure by one or more resilient hooks or straps; (f) at least one lower fabric portion includes one or more rigid sections; and / or (g) at least one lower fabric portion has higher rigidity at its intermediate section than at its ends.

[0100] In examples of the aforementioned embodiments, (a) the patient interface includes one or more sensors disposed in or on the upper fabric portion, and / or at least one lower fabric portion, and / or the plenum chamber, and / or the seal-forming structure; (b) the patient interface includes one or more actuators disposed in or on the upper fabric portion, and / or at least one lower fabric portion, and / or the plenum chamber, and / or the seal-forming structure; (c) the at least one sensor and / or the at least one actuator are partially exposed to the environment at an outer surface of the upper fabric portion or at least one lower fabric portion and / or are partially exposed at a patient-contacting surface of the upper fabric portion or at least one lower fabric portion so as to contact the patient's skin in use; (d) the at least one sensor or the at least one actuator is at least partially embedded between an outer layer of the upper fabric portion or at least one lower fabric portion and a patient-contacting layer; (e) the at least one sensor and / or the at least one actuator are partially exposed to the environment at an outer surface of the upper fabric portion or at least one lower fabric portion and / or are partially exposed at a patient-contacting surface of the upper fabric portion or at least one lower fabric portion so as to contact the patient's skin in use; (f) the patient interface includes one or more sensor holding structures for mounting the respective sensors and / or actuators; (g) the one or more sensor holding structures include one or more pockets for accommodating the one or more respective 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 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 the 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.

[0101] In examples of the foregoing embodiments, (a) the plenum chamber includes a shell, having an inner shell surface and an outer shell surface, the inner shell surface being arranged to be at therapeutic pressure during use and the outer shell surface being arranged to be at atmospheric pressure during use; (b) the at least one lower fabric portion engages at least a portion of the outer shell surface to hold the seal-forming structure in a therapeutically effective position; (c) the channel is formed in the outer shell surface; (d) the shell is constructed of a hard plastic material; and / or (e) the shell is constructed of a transparent material.

[0102] One form of the present technology includes a positioning and stabilizing structure for a patient interface including: A headband formed at least in part from a textile material, having an upper textile portion movably connected to a first lower textile portion, and including one or more sensors disposed in or on the upper textile portion and / or the first lower textile portion. wherein the headband is wearable on a patient's head in a first configuration in which the first lower fabric portion is adjacent to the upper fabric portion, and in a second configuration in which the first lower fabric portion is separated from the upper fabric portion to provide a force to hold the seal-forming structure of the patient interface in a therapeutically effective position on the patient's head.

[0103] In examples of the aforementioned embodiments, (a) the positioning and stabilizing structure includes one or more actuators provided in or on the upper textile portion and / or the first lower textile portion; (b) the at least one sensor and / or the at least one actuator is partially exposed to the environment on an outer surface of the upper textile portion or the first lower textile portion and / or is partially exposed on a patient-contacting surface of the upper textile portion or the first lower textile portion so as to contact the patient's skin during use; and (c) the at least one sensor and / or the at least one actuator is at least partially embedded between the outer layer of the upper textile portion or the first lower textile portion and the patient-contacting layer. (d) the at least one sensor and / or the 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 one or more sensor holding structures for mounting each one of the sensors and / or actuators; (f) the one or more sensor holding structures include one or more pockets for accommodating one or more respective sensors or actuators; (g) the positioning and stabilizing structure 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 at the one or more actuators from the one or more external computing devices; and / or (h) the one or more sensors and / or the 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.

[0104] In an example of the foregoing embodiment, (a) the first lower fabric portion is integral with the upper fabric portion; (b) the headband includes a first portion of the upper fabric portion, further includes a first lower fabric portion, and includes a first bifurcated section disposed at a front portion of the headband; (c) the headband includes a second portion of the upper fabric portion, further includes a second lower fabric portion, and includes a second bifurcated section disposed at a rear portion of the headband; and (d) the first lower fabric portion is a seal retaining band that is resiliently stretchable along at least a portion of its length and engages with an outer surface of the patient interface to seal in a therapeutically effective position. (e) the seal retaining band is adapted to retain the forming structure; (f) the seal retaining band is adapted to be received in a channel of the patient interface; (g) the channel is formed in a plenum chamber of the patient interface; (h) the seal retaining band includes a port for coupling the seal forming structure to an air circuit for supplying pressurized air to the patient; (i) the first lower fabric portion includes one or more rigid sections; and / or (j) the first lower fabric portion has a higher rigidity at its midsection than at its ends.

[0105] One form of the present technology includes a patient interface that includes: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; 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 airways, said seal-forming structure having holes therein so that a flow of air at said therapeutic pressure is delivered to at least the entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle; 10. A positioning and stabilizing structure according to any of the preceding aspects or examples.

[0106] In example embodiments of the foregoing, (a) the patient interface further includes one or more sensors positioned in or on the interior surface of the plenum 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.

[0107] One form of the present technology includes a system for diagnosing and / or monitoring a respiratory disorder including: 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.

[0108] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a peripheral shape that is complimentary to the shape of the intended wearer.

[0109] One aspect of the present technology is a method for manufacturing a device.

[0110] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or acumen, or individuals with limited experience using such medical devices.

[0111] One aspect of one form of the present technology is a portable RPT device that can be carried by a person, for example, around a person's home.

[0112] One aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.One aspect of one form of the present technology is a humidification tank that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0113] The described methods, systems, devices, and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor of a special purpose computer, a respiratory monitor, and / or a respiratory treatment device). Further, the described methods, systems, devices, and apparatus enable advancements in the art of automated management, monitoring, and / or treatment of respiratory conditions (e.g., sleep-disordered breathing).

[0114] Of course, some of the above aspects may form sub-aspects of the present technology, and various sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0115] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawings]

[0116] 4 Brief description of the drawings The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include like elements: 4.1 Respiratory Treatment Systems [Figure 1A] The system is shown including a patient 1000 wearing a patient interface 3000 in the form of nasal pillows that receives air at positive pressure supplied from an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. A bed companion 1100 is also shown. The patient is sleeping in a supine sleeping position. [Figure 1B] The system is shown to include a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C]The system includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask that receives a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 Respiratory System and Facial Anatomy [Figure 2A] An outline of the human respiratory system, including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] 1 is a diagram of the human upper respiratory tract, including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, esophagus, and trachea. [Figure 2C] A front view of a face including several features of the surface anatomy including upper lip, vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and corners of the mouth. The superior, inferior, radially inward, and radially outward directions are also noted. [Figure 2D] A lateral view of the head including several features of the surface anatomy, including the glabella, serrion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior ear base, and inferior ear base. The superior and inferior, and anterior and posterior directions are also indicated. [Figure 2E]

[0023] Figure 1 is a further lateral view of the head, showing the approximate locations of the Frankfort horizontal and nasolabial angle. The coronal view is also shown. [Figure 2F] A bottom view of the nose including several features including the nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, major axis of the nostril, and midsagittal plane. [Figure 2G] FIG. 1 is a side view of the surface features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose, including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibro-adipose tissue. [Figure 2I]The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention paid to the nasal septum cartilage and the medial crus of the greater alar cartilage. [Figure 2J] FIG. 1 is a frontal bony view of the skull, including the frontal, nasal, and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 2K] This is a side view of the skull, showing the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius. [Figure 2L] Shows the anterolateral side of the nose. 4.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C is a schematic cross-sectional view of the structure taken at a point, showing the outward normal at this point, where the curvature at this point has a positive sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3C] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] A schematic cross-section of a structure cut at a point, showing the outward normal at this point, and the curvature value at this point is zero. [Figure 3E] 3F is a schematic cross-sectional view of the structure taken at a point, with the outward normal at this point shown, and the curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3F] 3B is a schematic cross-sectional view of the structure taken at point 1. The outward normal at this point is shown. The curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. 3E. [Figure 3G]1 shows a mask cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome region and saddle region are shown. [Figure 3H] 1 shows a cushion for a mask. The outer surface of the cushion is shown. The edge of the surface is shown. The path on the surface between points A and B is shown. The linear distance between A and B is shown. Two saddle regions and a dome region are shown. [Figure 3I] The surface of a structure is shown, with a one-dimensional hole drilled into the surface. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] 3B is a cross-sectional view through the structure of Figure 3I. The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. 3I are also shown. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] 3L is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left-hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] The right ear is shown, including the right ear helix. [Figure 3S] Shows a right-handed spiral. [Figure 3T] 1 is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] A diagram of the plenum chamber 3200 showing the sagittal and medial contact planes. [Figure 3V]A posterior view of the plenum chamber of Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 3V, a sagittal plane bisects the plenum chamber into a left-hand side and a right-hand side. [Figure 3W] 3V is a cross-sectional view through the plenum chamber of FIG. 3V, where the cross-section is taken in the sagittal plane shown in FIG. 3V. The "central contact" plane is shown. The central contact plane is perpendicular to the sagittal plane. The orientation of the central contact plane corresponds to the orientation of the tendon 3210. The tendon 3210 rests on the sagittal plane and only contacts the cushion of the plenum chamber at two points on the sagittal plane: superior point 3220 and inferior point 3230. Depending on the geometry of the cushion in this region, the central contact plane may contact both the superior and inferior points. [Figure 3X] The plenum chamber 3200 of Figure 3U is shown in a use position on the face. The sagittal plane of the plenum chamber 3200 generally coincides with the mid-sagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face plane" when the plenum chamber is in the use position. In Figure 3X, the plenum chamber 3200 is that of a nasal mask, with the upper point 3220 resting approximately on the selion and the lower point 3230 resting on the upper lip. [Figure 4A] FIG. 10 is a front perspective view of a positioning and stabilizing structure for a patient interface in accordance with one form of the present technology. [Figure 4B] FIG. 4B is a side view of a patient interface in accordance with one form of the present technology incorporating the positioning and stabilizing structure of FIG. 4A, shown in an in-use position above the patient's head. [Figure 4C] FIG. 4C is a front perspective view of the patient interface of FIG. 4B shown in an in-use position on the patient's head. [Figure 4D] FIG. 4B is an enlarged view showing the support zone of the positioning and stabilizing structure of FIG. 4A. [Figure 4E] FIG. 4B is a side view of the positioning and stabilizing structure of FIG. 4A worn by a patient in a first configuration. [Figure 4F] FIG. 4B is a side view of the positioning and stabilizing structure of FIG. 4A worn by a patient in a second configuration. [Figure 5A]FIG. 10 is a side view of a patient interface in accordance with one form of the present technology shown in an in-use position above a patient's head. [Figure 5B] FIG. 5B is a schematic illustration of a mechanism for coupling a seal-forming structure to a positioning and stabilising structure for the patient interface of FIG. 5A; [Figure 6] FIG. 10 is a front perspective view of a patient interface in accordance with one form of the present technology, shown in an in-use position above a patient's head. [Figure 7A] FIG. 10 is a side view of a patient interface in accordance with one form of the present technology shown in an in-use position above a patient's head. [Figure 7B] FIG. 7B is a schematic illustration of a mechanism for coupling a seal-forming structure to a positioning and stabilising structure for the patient interface of FIG. 7A; [Figure 7C] FIG. 7B is a front perspective view of the patient interface of FIG. 7A shown in an in-use position on a patient's head. [Figure 8A] FIG. 10 is a front perspective view of a patient interface in accordance with one form of the present technology, shown in an in-use position above a patient's head. [Figure 8B] FIG. 8B is an enlarged side view of the plenum chamber of the patient interface of FIG. 8A. [Figure 9A] 14 shows a positioning and stabilizing structure for a patient interface in accordance with one form of the present technology in an initial use position on a patient's head. [Figure 9B] 9B shows the positioning and stabilizing structure of FIG. 9A in a second use position on the patient's head as part of a patient interface. [Figure 9C] 9B is a schematic cross-sectional view through a portion of the positioning and stabilizing structure of FIG. 9A. 4.4 RPT Device [Figure 10A] 1 shows an RPT device in accordance with one form of the present technology. [Figure 10B]1 is a schematic diagram of an air pressure path of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are shown relative to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items located in the air pressure path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 10C] FIG. 10 is a schematic diagram of electrical components of an RPT device in accordance with one form of the present technology. [Figure 10D] FIG. 10 is a schematic diagram of an algorithm implemented in an RPT device in accordance with one form of the present technology. [Figure 10E] 10D in accordance with one form of the present technology. [Figure 11A]

[0023] Fig. 1 shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 11B] FIG. 5 shows an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 11C]

[0023] Fig. 1 shows a schematic diagram of a humidifier in accordance with one form of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0117] 5. Detailed Description of the Embodiments of the Present Technology Before describing the present technology in further detail, it is to be understood that the present technology is not limited to the specific embodiments described herein, which may vary. It is also to be understood that the terminology used in the present disclosure is for the purpose of describing the specific embodiments described herein, and is not intended to be limiting.

[0118] The following description is provided in connection with various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these embodiments may constitute an additional embodiment. 5.1 Treatment

[0119] In one form, the present technology includes a method of treating a respiratory disorder that involves applying positive pressure to the entrance of the airways of a patient 1000.

[0120] In certain embodiments of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0121] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented. 5.2 Respiratory Treatment Systems

[0122] In one form, the present technology includes a respiratory treatment system for the treatment of respiratory disorders. The respiratory treatment system may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 and a patient interface 3000. 5.3 Patient Interface

[0123] 3A , a non-invasive patient interface 3000 in accordance with one aspect of the present technology includes the following functional features: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional features may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional features. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's 1000 airway so as to maintain positive pressure at the entrance to the patient's 1000 airway. Thus, the sealed patient interface 3000 is suitable for delivery of positive pressure therapy.

[0124] Other examples of non-invasive patient interfaces 6000, 7000, 8000, 9000, 10000, and 11000 are also shown in Figures 4A-4F, 5A-5C, 6, 7A-7C, 8A-8B, and 9A-9C, and are described in more detail below.

[0125] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0126] A patient interface in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.

[0127] A patient interface in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.

[0128] A patient interface in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient. 5.3.1 Seal formation structure

[0129] In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further provide a cushioning function. The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient in a given treatment session from day to day, depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0130] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0131] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0132] A seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material (eg, silicone).

[0133] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, where each seal-forming structure 3100 is configured to accommodate a different size and / or shape range. For example, the system may include one form of seal-forming structure 3100 that is suitable for large head sizes but not small head sizes, and another that is suitable for small head sizes but not large head sizes. 5.3.1.1 Sealing mechanism

[0134] In one form, the seal-forming structure includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum chamber 3200 by acting on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0135] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the periphery of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the periphery. The support flange is or includes a spring-like element that functions to support the sealing flange so that it buckles during use.

[0136] In one form, the seal-forming structure may include a compressive or gasket sealing portion that is constructed and arranged to be in compression in use due to, for example, elastic tension in the positioning and stabilizing structure.

[0137] In one form, the seal-forming structure includes a tensioning portion that, in use, is held taut by, for example, an adjacent region of the sealing flange.

[0138] In one form, the seal-forming structure includes an area having a sticky or adhesive surface.

[0139] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or adhesive surface. 5.3.1.2 Nasal bridge or nasal ridge area

[0140] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal on the nasal bridge or nasal ridge region of the patient's face.

[0141] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the nasal bridge or nasal ridge region of the patient's face in use. 5.3.1.3 Upper lip area

[0142] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the upper lip region (ie, upper lip) of the patient's face.

[0143] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face in use. 5.3.1.4 Jaw area

[0144] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the chin area of ​​the patient's face.

[0145] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the chin region of the patient's face in use. 5.3.1.5 Frontal Area

[0146] In one form, the seal-forming structure forms a seal on the forehead region of the patient's face when in use, and in such a form, the plenum chamber may cover the eyes when in use. 5.3.1.6 Nasal pillow

[0147] In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

[0148] Nasal pillows according to one aspect of the present technology include a truncated cone. At least a portion of the truncated cone forms a seal over the underside of the patient's nose, the stem, and a flexible region on the underside of the truncated cone, connecting the truncated cone to the stem. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the base of the stem. The flexible region can function to facilitate a universal joint structure. The universal joint structure accommodates both the displacement and angle of the truncated cone and the relative movement of the structure to which the nasal pillows are connected. For example, the truncated cone can be displaced axially toward the structure to which the stem is connected. 5.3.2 Plenum chamber

[0149] The plenum chamber 3200 has edges shaped to complement the surface contours of an average human face in the area where a seal is formed in use. In use, the periphery of the plenum chamber 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire periphery of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single, homogenous piece of material.

[0150] In certain forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes when in use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. Such a form tends to be less intrusive and / or more comfortable for the wearer and may improve compliance with treatment.

[0151] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material, such as clear polycarbonate. The use of a transparent material may reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of a transparent material may help the clinician see the placement and function of the patient interface.

[0152] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material, which can make the patient interface less intrusive and help improve compliance with treatment. 5.3.3 Positioning and stabilizing structures

[0153] The seal-forming structures 3100, 6100, 7100, 8100, 9100, 10100, 11100 of the patient interface 3000, 6000, 7000, 8000, 9000, 10000, 11000 of the present technology may be held in a sealed position by the positioning and stabilising structures 3300, 6300, 7300, 8300, 9300, 10300, 11300 in use.

[0154] In one form, the positioning and stabilizing structure 3300, 6300, 7300, 8300, 9300, 10300, 11300 provides at least sufficient retention force to overcome the effect of positive pressure in the plenum chamber 3200, 6200, 7200, 8200, 10200, 11200 to lift off the face.

[0155] In one form, the positioning and stabilizing structure provides a holding force sufficient to overcome the attractive force on the patient interface.

[0156] In one form, the positioning and stabilizing structure provides a holding force as a safety margin to eliminate potentially destructive effects on the patient interface, such as tube drag or inadvertent interference with the patient interface.

[0157] In one form of the present technology, there is provided a positioning and stabilizing structure configured to be worn by a patient while sleeping. In one embodiment, the positioning and stabilizing structure has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilizing structure includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilizing structure includes at least one flat strap.

[0158] In one form of the present technology, a positioning and stabilizing structure is provided that is configured so that it does not have an excessively large or bulky size that would interfere with a patient sleeping in a supine sleep position with the posterior region of the patient's head resting on a pillow.

[0159] In one form of the present technology, a positioning and stabilizing structure is provided that is configured so that it does not have an excessively large or bulky size that would interfere with a patient sleeping in a lateral sleeping position with the side region of the patient's head resting on a pillow.

[0160] In one form of the present technology, the positioning and stabilizing structure includes a strap constructed from a laminate of a fabric patient-contacting 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 additionally, the strap may include fiberfill (e.g., polyester fiberfill), nonwoven padding, foam padding, high-density upholstery foam, compressed polyester, medium-density polyurethane antibacterial foam, high-density polyurethane foam, quick-drying open-cell foam, or combinations thereof. As a result, the strap is not too large or bulky and does not interfere with the patient's sleep in a lateral sleep position. Additionally, the strap is stretchy and soft.

[0161] In certain forms of the present technology, the positioning and stabilizing structure includes an extensible (e.g., elastically extensible) strap, For example, the strap may be configured to be tensioned in use to direct a force that urges the seal-forming structure into intimate contact with a portion of the patient's face.

[0162] 4A-4F, the patient interface 6000 includes a positioning and stabilizing structure or headgear 6300 including an upper textile portion 6310 including a circumferential band for fitting to the patient's head in use. A first lower textile portion 6320 is movably (e.g., articulatably, hingedly, pivotally, etc.) connected to the upper textile portion 6310. For example, the first lower textile portion 6320 may be integral with the upper textile portion 6310. Alternatively, the first lower textile portion 6320 may be joined to the upper textile portion 6310 by, for example, stitching, ultrasonic welding, or other techniques. For example, respective ends of the first lower textile portion 6320 may be joined at respective seams 6322 and 6324 near bifurcation points 6312 and 6314 located on opposite sides of the positioning and stabilizing structure 6300. The textile portions 6310, 6320 are stretchable so that the length of each portion in use is equal to or greater than its corresponding rest length, thus avoiding wrinkling of the textile material of the portions 6310, 6320.

[0163] The positioning and stabilising 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 plenum chamber 6200 and a connection port 6600 for connecting the plenum chamber 6200 to the air circuit 4170.

[0164] In this example, the positioning and stabilizing structure 6300 is formed as a band having an anterior or front section 6302 and a posterior or back section 6304, the anterior section 6302 being bifurcated (at points 6312, 6314) such that a first fork forms a first portion of an upper fabric portion 6310 and a second fork forms a first lower fabric portion 6320. Thus, as shown in FIG. 4B , the upper fabric portion 6310 forms a first band or strap that may encircle the patient's forehead in use, while the first lower fabric portion 6320 forms a second band or strap that is stretchable downwardly and directly or indirectly engages the seal-forming structure 6100 to provide a force to hold the seal-forming structure 6100 in a therapeutically effective position on the patient's head.

[0165] In some forms, the front section 6302 may have substantially the same width as the back section 6304. In other words, the width across both the first portion of the upper fabric portion 6310 and the first lower fabric portion 6320 is substantially equal to the width of the back section 6304. This may allow the positioning and stabilizing structure 6300 to have a substantially constant width of material at any point along the positioning and stabilizing structure 6300.

[0166] 4A-4F , the positioning and stabilizing structure 6300 can be worn as a headband with both fabric portions 6310, 6320 surrounding the patient's forehead, allowing the patient to become familiar with the feel of the structure 6300 before beginning treatment. The upper fabric portion 6310 can be configured to surround the patient's forehead such that the front section (or front portion) of the upper fabric portion 6310 is configured to engage with the front portion of the patient's head, and the back section (or rear portion) of the upper fabric portion 6310 is configured to engage with the rear portion of the patient's head. Similarly, the lower fabric portion 6320 can be configured to surround the patient's forehead such that the back section (or rear portion) of the first lower fabric portion 6320 is configured to engage with 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 one another (e.g., adjacent, close together, etc.) on the patient's forehead. During use, the front section (or front portion) of the first lower fabric portion 6320 is configured to move to a second position and overlap the cheek region, preferably the upper cheek region, of the patient's face, extending between the patient's ear and the top of the patient's eye. Furthermore, prior to initiating treatment, the first lower fabric portion 6320 can be easily pulled down (as shown by the dotted lines in FIGS. 4E and 4F ) to engage and apply tension to the plenum chamber 6200 (as shown in FIGS. 4B-4D ), for example, by nesting within an external groove or channel 6210 of the plenum chamber 6200. In the second position, the first lower fabric portion 6320 can be positioned proximate the patient's mouth (e.g., resting on the patient's upper lip), while the upper fabric portion 6310 can remain in substantially the same position (e.g., above the patient's forehead) such that the first lower fabric portion 6320 is at least partially spaced from the upper fabric portion. For example, the branched portions of the front section 6302 may be spaced apart from one another (eg, to avoid clamping against the patient's head and obstructing the patient's eyes).However, the anterior section 6302 and the posterior section 6304 remain formed contiguously in the second position, and the combined width of the spaced-apart anterior section 6302 remains substantially equal to the width of the posterior section 6304. The positioning and stabilizing structure 6300 may be worn without the air circuit 4170 being connected and / or the pressure generator 4140 of the RPT device 4000 being switched on prior to initiating treatment. This allows the patient to become accustomed to wearing the patient interface 6000 without experiencing discomfort from the positive pressure provided by the pressure generator 4140. Thus, the patient can be gradually transitioned to respiratory therapy, improving the likelihood of compliance once treatment actually begins.

[0167] Thus, the positioning and stabilizing structure 6300 can be easily transformed between a first position or non-treatment configuration (e.g., for monitoring and / or diagnostic purposes when sensors are provided on the positioning and stabilizing structure 6300, as described below) and a second position or treatment or pre-treatment configuration by a simple pivoting movement.

[0168] Some forms of the present technology may include a padding structure attached to or integrated with either or both of the upper and lower fabric portions 6310, 6320. The padding structure may include a layer of soft foam or soft woven and / or knitted or nonwoven fabric integrated within or attached to the upper and / or lower fabric portions 6310, 6320. Alternatively, the padding structure may include one or more sleeves of such padding material provided around the outside of the upper and / or lower fabric portions 6310, 6320. The padding structure may provide improved comfort to the wearer.

[0169] In some forms of the present technology, the lower textile portion 6320 may be more stretchable than the upper textile portion 6310, thereby allowing the lower textile portion 6320 to more easily stretch downward to engage with the plenum chamber 6200, as shown in FIG. 4F. For example, the stretch properties of the portions 6310, 6320 may be tailored by employing different types of knitting, such as warp knitting, weft knitting, or a combination of both. In one example, a narrow double knitting machine bar warp knit may be used to form the lower textile portion 6320, or at least a portion thereof, to provide extra stretch and length to the upper textile portion 6310 for engagement with the plenum chamber 6200.

[0170] The upper and lower textile portions 6310 and 6320 may be made from the same fabric (or fiber). The fabric may be nylon, polyester, polypropylene (PP), elastane, or a combination of any two or more thereof. Elasticity may be varied by changing the combination of textile materials (i.e., blend ratio), yarn count, yarn density, yarn size, and / or by changing the steps and conditions of the textile manufacturing process.

[0171] The fabric may include a core yarn comprising a core and a cover. The core yarn may include polyurethane fibers and / or elastomeric fibers (such as rubber fibers and silicone fibers) to achieve desired stretchability, while the cover may be made from nylon, polyester, and / or polypropylene. The filaments used in the cover may also be continuous filaments processed to achieve better softness, durability, better insulation, high permeability, and better moisture transport (i.e., moisture absorption).

[0172] The width of each of the upper and lower fiber portions 6310, 6320 can be less than 40 mm. In some forms, the width is less than 30 mm. The width may be greater than 3 mm. The fiber portions 6310 and 6320 may be of different widths. For example, the upper fiber portion 6310 may be wide (e.g., greater than 10 mm and less than 30 mm, or greater than 15 mm and less than 25 mm) to accommodate sensors and circuitry, and the lower fiber portion 6320 may be narrower (e.g., less than 10 mm or less than 15 mm) to avoid visual obstruction.

[0173] The upper fabric portion 6310 may be arranged to be less stretchy and thicker than the lower fabric portion 6320 to ensure that the upper fabric portion 6310 retains its shape, while the lower fabric portion 6320 is arranged to be more easily stretched downward (where the plenum chamber 6200 is held for use). For example, the fabric thickness of the upper fabric portion 6310 may range from about 0.30 mm to about 1.50 mm, and the fabric thickness of the lower fabric portion 6320 may range from about 0.20 mm to about 1.00 mm.

[0174] The positioning and stabilizing structure 6300 may be constructed by weaving strips of material having branch points 6312, 6314, and then the ends of the strips of material may be attached (at joints 6332, as shown in FIG. 4A) to form the positioning and stabilizing structure 6300.

[0175] In some embodiments, after two separate portions are knitted, they may be attached together by any suitable means. For example, a first (upper) circumferential band may be joined to a second (lower) circumferential band by a joining section or seam extending partially around their respective circumferences, leaving at least one unjoined section where the two bands are separable (e.g., extending between bifurcation points 6312 and 6314 or between seams 6322 and 6324). The first and second circumferential bands may be formed from different textile materials and / or may have different degrees of stretchability. The bond between the two portions may be formed by knitting, stitching, adhesive (including rigid or elastically deformable adhesive patches), ultrasonic bonding, heat sealing, or a combination of any two of these.

[0176] In some forms of the present technology, the stretch or stiffness of the first lower fabric portion 6320 may vary along its length. For example, as depicted in FIG. 4D , the middle section 6326 of the first lower fabric portion 6320 positioned for direct engagement with the plenum chamber 6200 (e.g., within its groove 6210) may be stiffer 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 may be stiffened to increase the stability of the headgear 6300 during use and / or to change the direction of tension to prevent the first lower fabric portion 6320 from riding up on the patient's cheekbones and covering their eyes.

[0177] In some forms of the present technology, one or more rigidizers may be provided to selectively modify the stiffness of the first lower fabric portion 6320. These may be attached to the first lower fabric portion 6320 or inserted between layers thereof. For example, the middle section 6326 may include a rigidizer laminated or embedded between layers of the lower fabric portion 6320. Alternatively, a thermosetting thread may be used to provide selective stiffening to the middle section 6326. The fabric may be stiffened in other portions of the lower fabric portion 6320, for example along the side sections that contact the patient's face in use, using, for example, coatings, laminations, stiffening threads sewn into the fabric, or any similar means.

[0178] In some forms, the positioning and stabilizing structure may include a patient-contacting structure having one or more resilient straps extending therefrom for engaging a harness that holds the seal-forming structure in place.

[0179] 5A, the patient interface 7000 includes a positioning and stabilizing structure 7300, which also includes a patient-contacting structure 7301 that provides tension to the seal-forming structure 7100, which cooperates with a harness 7329 to maintain the seal-forming structure 7100 in a therapeutically effective position on the patient's head. The patient interface 7000 also includes a plenum chamber 7200 having a connection port 7600 for connecting the patient interface 7000 to the air circuit 4170.

[0180] In one form of the present technology, the positioning and stabilizing structure 7300 includes an upper fabric portion 7310 and two lower fabric portions movably connected (e.g., articulatably, hingedly, pivotably, etc.) to the upper fabric portion 7310. The positioning and stabilizing structure 7300 also includes a posterior section 7304 configured to secure against the posterior surface of the patient's neck. The upper fabric portion 7310, in use, is adapted to surround the patient's head in an area above the superior-ear base of the patient's head.

[0181] The lower fabric portion may include a first arm 7326 and a second arm 7328. Each arm may have a hook, for example, a hook 7349 extending from the second arm 7328 (FIG. 5B), for engaging a corresponding catch 7330 located on the harness 7329. For example, the hook 7349 may be formed from a length of elastic thread material, the ends 7346, 7348 of which are located within respective channels 7342, 7344 on the second arm 7328. By forming the hook 7349 from an elastic material, the hook 7349 may be easily extended to engage the catch 7330, yet also be able to retract 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 specifically shown in Figures 5A and 5B, it will be understood that the same structure (or a similar structure) may be provided on the first arm 7326 for engaging a further catch on the opposite side of the harness 7329 so that the two hook-catch pairs cooperate to hold the harness 7329, and therefore the seal-forming structure 7100, in place on the patient's head.

[0182] 5A and 5B as extending from the exterior (non-patient-contacting) surface of the second arm 7328. It will be understood that in some forms of the present technology, the hook 7349 may instead extend from a channel located on the interior (patient-contacting) surface of the second arm 7328, but generally for greater patient comfort it will be desirable to use the exterior arrangement as shown in FIGS.

[0183] The first arm 7326 and the second arm 7328 may have different stiffness along at least a portion of their length relative to the upper fabric portion 7310 and the rear portion 7304 of the patient-contacting structure 7301. For example, each of the first and second arms 7326, 7328 may be stiffer than the upper fabric portion 7310 and the rear portion 7304 at least in its midsection. By increasing the stiffness of at least the midsections of the two arms 7326, 7328, the positioning and stabilizing structure 7300 provides increased support to the seal-forming structure 7100, reducing movement and providing better dynamics during respiratory therapy. Furthermore, similar to the stiffening described above with respect to the positioning and stabilizing structure 6300, selectively increasing the stiffness of the arms 7326, 7328 helps direct tension vectors away from the patient's eyes during use. In some embodiments, the arms 7326, 7328 may be formed using thermosetting yarn to provide the desired stiffness.

[0184] In one form, one or more rigidizers may be provided on the arms 7326, 7328. The rigidizers may be semi-rigid. In other words, the rigidizers may be stiffer than the fiber material used to form the arms 7326, 7328 and / or upper fiber portion 7310, but not completely rigid. In this way, they can provide structure to the arms 7326, 7328, but are flexible and therefore bendable. The patient and / or medical professional may adjust or bend the rigidizers to provide support tailored to the individual patient. The rigidizers may also start out semi-rigid (in other words, they may be semi-rigid at the start or initially) and become rigid after a period of time. For example, a medical professional may adjust the shape of the rigidizers so that the positioning and stabilizing structure 7300 is adapted to the individual patient's face. The rigidizers may then be treated (e.g., heat treated) to set them in their shape. In other words, the rigidizer's stiffness is variable. As a result, the stiffness of the arms 7326, 7328 may also be varied and selectively increased to provide tailored support for an individual patient (or patients).

[0185] 6, a patient interface 8000 includes a seal-forming structure 8100 that includes one or more catches 8220 that can engage with corresponding hooks on a positioning and stabilizing structure 7300 to hold 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 cooperates with such a seal-forming structure 8100 to form a patient interface 8000 that also includes a plenum chamber 8200 and a connection port 8600 for connection to the air circuit 4170. Thus, the patient-contacting structure 7301 may be used with an intermediate structure, such as a harness as shown in FIGS. 5A and 5B, to hold the seal-forming structure, or may directly engage the seal-forming structure (the seal-forming structure including a suitable engagement mechanism, such as the catch 8220 of structure 8100). The harness-type configuration is advantageous in that it can be used with a variety of existing seal-forming structures 7100, while the configuration of Figure 6 is advantageous in that direct engagement with the seal-forming structure 8100 can provide more stable support for the seal-forming structure 8100.

[0186] In some embodiments, multiple catches 8220 may be provided at multiple different locations on the seal-forming structure 8100 or another structure connected to the seal-forming structure, such as the plenum chamber 8200, and tension within the positioning and stabilizing structure 7300 may be adjusted by attaching the hooks 7349 to the catches 8220 at different locations. Similarly, multiple catches 7330 may be provided at multiple different locations on the harness 7329 of FIGS. 5A and 5B for this purpose.

[0187] 7A-7C , a patient interface 9000 includes a positioning and stabilizing structure 9300 which also includes a patient contacting structure 9301 that provides tension to the seal-forming structure 9100, which cooperates with a harness 9329 to maintain the seal-forming structure 9100 in a therapeutically effective position on the patient's head. The patient interface 9000 also includes a plenum 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 harness 9329 to the patient contacting structure 9301.

[0188] In one form of the present technology, the positioning and stabilizing structure 9300 includes an upper fabric portion 9310 and two lower fabric portions movably (e.g., articulatably, hingedly, pivotably, etc.) connected to (e.g., integral with) and extending from the upper fabric portion 9310. The positioning and stabilizing structure 9300 also includes a posterior section 9304 configured to secure against the posterior surface of the patient's neck or occipital bone. The upper fabric portion 9310, in use, is adapted to surround the patient's head in a region above the superior-basal point of the patient's head.

[0189] The lower fiber portion can include a first arm 9326 and a second arm 9328. Each arm can have a hook, e.g., hook 9349, extending from the second arm 9328 (FIG. 7B), to engage with a corresponding catch (not shown) located on the harness 9329. For example, the hook 9349 can be an elastic strap that can be received in a channel 9342 on the exterior (non-patient-contacting) surface of the second arm 9328 and extended from the channel 9342 to engage with a catch on the harness 9329. When the strap 9349 is released, it at least partially returns to the channel 9342.

[0190] The strap 9349 may be attached to the harness 9329 via a hook-and-loop arrangement. For example, a first patch bearing hooks (or loops) on its surface may be provided on the strap 9349, and a second patch bearing loops (or hooks) on its surface may be provided on the harness 9329, so that the patient can attach the strap 9349 to the harness 9329 by contacting the first patch with the second patch. Furthermore, tension may be adjusted by changing the relative positions of the first and second patches upon contact. The hook-and-loop arrangement may include a hook component including nanoscale protrusions and a loop component including a nanofiber pile fabric. One such hook-and-loop system is sold by Teijin Limited under the trademark FASTENANO. In another possible arrangement, the strap 9349 may include an array of spikes or similar protrusions that may be embedded in the material of the harness 9329 to attach the harness.

[0191] Although not specifically shown in Figures 7A-7C, it will be understood that the same structure (or a similar structure) may be provided on the first arm 9326 for engaging a further catch on the opposite side of the harness 9329 so that the two hook-catch pairs cooperate to hold the harness 9329, and thus the seal-forming structure 9100, in place on the patient's head.

[0192] The first arm 9326 and the second arm 9328 may have different stiffness along at least a portion of their length relative to the first resilient fiber portion 9310 and the rear portion 9304 of the patient-contacting structure 9301. For example, each of the first and second arms 9326, 9328 may be stiffer than the first resilient fiber portion 9310 and the rear portion 9304 at least in its midsection. By increasing the stiffness of at least the midsections of the two arms 9326, 9328, the positioning and stabilizing structure 9300 provides increased support to the seal-forming structure 9100 and reduces movement during respiratory therapy. Advantageously, the arms 9326, 9328 may be formed using thermosetting yarn to provide the desired stiffness. Alternatively, or additionally, similar stiffening mechanisms as discussed above may be employed, such as the provision of rigidizers attached to or embedded between layers of the arms 9326, 9328.

[0193] 8A and 8B , a patient interface 10000 includes a positioning and stabilizing structure 10300 and a plenum chamber 10200 having a connection port 10600 for connecting the patient interface 10000 to an air circuit 4170. The positioning and stabilizing structure 10300 is constructed and arranged to provide a force that maintains the seal-forming structure 10100 of the patient interface in a therapeutically effective position on the patient's head.

[0194] In one form of the present technology, the positioning and stabilizing structure 10300 includes an upper fabric portion 10310 and two lower fabric portions movably (e.g., articulatable, hinged, pivotable, etc.) connected to (e.g., integral with) and extending from the first resilient fabric portion 10310. The positioning and stabilizing structure 10300 also includes a posterior section 10304 configured to secure against the posterior surface of the patient's neck. The first resilient fabric portion 10310 is adapted to encircle the patient's head in use, for example, the area above the superior-ear base of the patient's head.

[0195] 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 may be resiliently coupled with the plenum chamber 10200 in use to maintain the seal-forming structure 10100 in place. For example, the plenum chamber 10200 may have a first wing (not shown) and a second wing 10220 extending therefrom, each adapted to couple to each of the arms 10326, 10328. For example, each wing may carry part of a fastener, such as a button, clip, or the like, adapted to mate with a corresponding part 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) may 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, 9300. Additionally, the wings may carry spikes or similar structures that may penetrate the arms 10326 and 10328 for attachment. If the wings are formed from a textile material or have a textile outer layer, the spikes or similar structures may be carried on the exterior or interior (patient-facing) surfaces of the arms 10326 and 10328 for embedding into the fibers of the textile material of the wings for attachment.

[0196] The wings 10220 may be formed from a variety of materials, such as fibers, polymers, elastomers, or combinations thereof.

[0197] The first arm 10326 and the second arm 10328 may have different stiffness along at least a portion of their length relative to the upper fabric portion 10310 and the rear section 10304, respectively. For example, each of the first and second arms 10326, 10328 may be stiffer than the upper fabric portion 10310 and the rear section 10304, at least in its mid-section. The arms 10326, 10328 may be formed using thermoset yarns to provide the desired stiffness and / or using one or more rigidizers provided in or on the arms 10326, 10328. The ends of each of the arms 10326, 10328 that connect to the wings 10220 may be relatively more elastic than the mid-section to provide the necessary tension to keep the seal-forming structure 10100 in place when connected to the wings.

[0198] In some forms of the present technology, a humidity exchanger 10230 may be provided within the plenum chamber 10200. The humidity exchanger 10230 is a passive component positioned in the flow path to absorb moisture and heat from the exhaled air flow and donate it to the inlet. One advantage of including a humidity exchanger 10230 in the plenum chamber is that the need for active humidification (such as by a humidifier 5000) may be reduced or eliminated. The humidity exchanger 10230 reduces the likelihood of dry mouth, which may be particularly important for patients who tend to breathe through their mouths and may find this uncomfortable. It will be understood that a similar humidity exchanger may be provided in the plenum chamber of any of the other forms of the technology described herein.

[0199] In one form of the present technology, as shown in FIGS. 9A and 9B, the positioning and stabilizing structure 11300 of the patient interface 11000 may have a connection port 11600 integrated therein to facilitate conversion from a first position or non-treatment configuration in which the positioning and stabilizing structure is worn as a headband, as in FIG. 9A, to a second position or treatment (or pre-treatment) configuration in which the positioning and stabilizing structure 11300 is connectable via the connection port 11600 to an air circuit 4170 in communication with the plenum chamber 11200, as in FIG. 9B.

[0200] While many different connection configurations between the air circuit 4170 and the connection port 11600 are possible, a substantially airtight seal is formed to substantially prevent pressure leakage during treatment. For example, the port 11600 may include a magnetic element 11610 located on its interior surface for connecting to a corresponding magnetic element located on a connector on one end of the air circuit 4170. In another example, the connector of the air circuit may attach to the connection port 11600 by a snap fit (which may be either rigid-to-rigid or rigid-to-resilient, such as an annular snap fit or a cantilever snap fit) or a friction fit.

[0201] As shown in FIG. 9A , the positioning and stabilizing structure 11300 includes an upper fabric portion 11310 including a resilient circumferential band for conforming to a patient's head during use. A first lower fabric portion 11320 is movably (e.g., articulatably, hingedly, pivotally, etc.) connected to (e.g., integral with) and extends from the upper fabric portion 11310. The positioning and stabilizing structure 11300 is used to apply force to the seal-forming structure 11100, as shown in FIG. 9B . The seal-forming structure 11100 may be a nasal mask having a plenum chamber 11200. Other types of masks, such as full face masks and oronasal masks, may also be used with the positioning and stabilizing structure 11300 as part of a patient interface.

[0202] In this example, the positioning and stabilizing structure 11300 is formed as a band having a front (anterior) section 11302 and a back (posterior) section 11304, the front section 11302 having a first bifurcated section (extending between bifurcations 11312, 11314) such that a first fork forms a first portion of the upper fabric portion 11310 and a second fork forms the first lower fabric portion 11320. Thus, as shown in FIG. 9A , the upper fabric portion 11310 forms a first band or strap that may encircle the patient's forehead in use, while the first lower fabric portion 11320 forms a second band or strap that is stretchable downwardly and directly or indirectly engages the seal-forming structure 11100 to provide a force to hold the seal-forming structure 11100 in a therapeutically effective position on the patient's head.

[0203] In some forms of the present technology, the posterior section 11304 may also include a bifurcated section that includes a first posterior portion 11306, which is a second portion of the upper fiber portion 11310, and a second posterior portion 11308, which is a second lower fiber portion, as shown in FIG. 9B. The bifurcation of the posterior section 11304 allows for a greater degree of support as tension can be applied at spaced locations behind, at the back of, or adjacent to the occipital bone of the patient's head, and also provides a greater degree of adjustability so that the patient may more comfortably position the positioning and stabilizing structure 11300. It will be understood that the posterior sections 6304, 7304, 9304, 10304 of any of the other forms of the present technology disclosed herein may also be bifurcated in a manner similar to the posterior section 11304 of the positioning and stabilizing structure 11300 of FIG. 9B.

[0204] In some forms, the rear section 11304 may be similar to the front or anterior section described above (e.g., the anterior section 6302). For example, the rear section 11304 may include a width that combines the measured widths of the first anterior portion 11306 and the second anterior portion 11308. This combined width may be substantially similar to the combined width of the first lower fabric portion 11320 and the first portion of the upper fabric portion 11310 (e.g., which together form the anterior section 11302).

[0205] The rear section 11304 may also be movable between a first position and a second position. As above, the rear section 11304 may be in a first position when the first rear portion 11306 and the second rear portion 11308 are positioned close to each other. The rear section 11304 may be in a second position when the first rear portion 11306 and the second rear portion 11308 are spaced apart from each other.

[0206] In certain configurations (see, e.g., FIG. 9A ), the posterior section 11304 can be in the first position when the first and second posterior portions 11306, 11308 are positioned on a lower portion of the patient's head (e.g., resting on the occipital bone, adjacent to the patient, etc.). Alternatively, the first and second posterior portions 11306, 11308 can be positioned slightly higher on the patient's head such that at least one rests on the parietal bone.

[0207] In certain configurations (see, e.g., FIG. 9B ), the posterior section 11304 can be in a second position when the first and second posterior portions 11306, 11308 are spaced apart from one another. When the entire positioning and stabilizing structure 11300 is in the second position, the anterior section 11304 and the posterior section 11306 can combine to form an X-shape when viewed from the side of the patient's head.

[0208] In certain forms, the first posterior portion 11306 can be moved relative to the second posterior portion 11308 from a first position to a second position (e.g., upward to rest on the parietal bone). In other forms, the second posterior portion 11308 can be moved relative to the first posterior portion 11306 from a first position to a second position (e.g., downward). In yet other forms, both the first posterior portion 11306 and the second posterior portion 11308 can be moved away from each other relative to the second posterior portion 11308 from a first position to a second position (e.g., upward to rest on the parietal bone).

[0209] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps that are bendable, e.g., non-rigid. An advantage of this embodiment is that the straps are more comfortable when the patient lies down to sleep.

[0210] In certain forms of the present technology, the positioning and stabilizing structure includes straps configured to be breathable to allow water vapor to pass therethrough.

[0211] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large sized heads but not for small sized heads, and another form of positioning and stabilizing structure 3300 that is suitable for small sized heads but not for large sized heads. 5.3.3.1 Patient Interface Sensor and Actuator Placement

[0212] In some forms of the present technology, the patient interface may have one or more sensors and / or actuators provided therein for measuring the patient's physiological and sleep data. The one or more sensors and one or more actuators may be embedded within the patient interface, for example, between fabric layers of the patient interface's headgear, or may be attached to the interior and / or exterior surfaces of the headgear or other components of the patient interface. For example, the one or more sensors and / or actuators may be integrated into the positioning and stabilizing structure and / or into another component such as a seal-forming structure or a plenum chamber.

[0213] In some forms, the headgear may include one or more leads, cables, or other conductive elements extending therefrom and in electrical communication with one or more of the sensors or actuators. Each such conductive element may include a terminal end capable of contacting the skin of a wearer of the headgear to provide one or more suitable signal ground points on the wearer's face or head, such as behind the ear or below the eye socket. This may be useful for implementing an EEG, EMG, or EOG system within the headgear.

[0214] Sensors embedded in the patient interface can help collect physiological indicators, such as sleep-related data and vital data, which can be used to determine improvements in sleep and health by comparing data before and after treatment begins. This data can be processed to inform the patient of how the treatment is improving their sleep. For example, before starting treatment, the patient can wear a positioning and stabilizing structure 11300 with integrated sensors as a headband, as shown in FIG. 9A, and physiological and sleep data can be recorded while the patient is sleeping (and during the day, in the case of physiological data). After treatment begins, using the positioning and stabilizing structure 11300 in the treatment configuration shown in FIG. 9B, further physiological and sleep data can be recorded and compared with the data recorded before treatment began. The physiological and sleep data can be communicated to an external computing device, such as the patient's smartphone, and / or to a monitoring server operated or accessible by a clinician or other healthcare provider.

[0215] Patient compliance is more likely because the patient can wear the positioning and stabilizing structure 11300 as a headband, facilitating adaptation, and because they receive data-based feedback on how the treatment is actually helping them (e.g., via an application running on their smartphone). The collected data may also be useful in determining population-level sleep and / or physiological characteristics of one or more groups of patients receiving respiratory therapy, potentially allowing for better customization of treatment to specific categories of patients, as well as other optimizations of the operation of the RPT device 4000.

[0216] In some forms of the present technology, measurement of functional parameters at the patient side using sensors integrated into and / or attached to the mask may 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 (FIG. 10B).

[0217] 9B and 9C, the upper fiber portion 11310 of the positioning and stabilizing structure 11300 may have multiple electronic modules (actuators and / or sensors) 11354, 11356, 11358, and 11360 integrated therein. A processor module 11350 may also be integrated into the positioning and stabilizing structure 11300, typically into the upper fiber portion 11310, although it will be understood that the processor module 11350 may be located elsewhere within the positioning and stabilizing structure 11300. The processor module 11350 may have an integrated transceiver for transmitting data to and receiving data 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 processor module 11350).

[0218] 9C , sensors and associated electronics may be at least partially integrated between the fabric layers of the upper textile portion 11310. For example, various sensor / actuator modules and / or associated circuitry, a processor module 11350, and a battery module 11352 may be placed between an inner, patient-contacting fabric layer 11370 and an outer, non-patient-contacting fabric layer 11372.

[0219] The sensor and / or actuator modules integrated into the positioning and stabilizing structure 11300 may be in electrical communication with the processor 11350 and the battery 11352, for example, via a bus 11365. The bus 11365 may be provided between two insulating layers 11366 that provide electrical insulation and prevent the ingress of moisture, such as sweat absorbed by the inner fabric layer 11370. The insulating layer 11366 may be, for example, a non-conductive polymer or elastomeric film, although it will be understood that other electrically insulating materials may also be used.

[0220] In some forms of the present technology, an insulating layer may be provided between at least some of the electronic components of the positioning and stabilizing structure 11300; however, it should be noted that these components tend to generate heat during use. The insulating layer therefore serves to improve patient comfort. For example, the layer 11366 closest to the inner layer 11370 that contacts the patient may be insulating as well as electrically insulating, or an additional insulating layer may be sandwiched between the electrically insulating layer 11366 and the inner layer 11370. In some examples, the inner layer 11370 itself may be insulating.

[0221] In some forms of the present technology, the sensor and / or actuator modules 11354-11360 and their associated circuitry, as well as other modules including the processor 11350 and battery 11352, may be received within sensor holding structures 11380-11390 attached to the insulating layer 11366 and / or inner fabric layer 11370. Each sensor holding structure 11380-11390 is in electrical communication with, for example, the bus 11365 and may include electrical contacts, for example, for electrically connecting the sensor module's (or associated) circuitry 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 traces and / or conductive yarns woven into or otherwise integrated with the fabric layers 11370 and / or 11372. In some embodiments, electrical contacts and / or circuit traces may be contained only on the outer layer 11372 so as not to be affected by sweat from the patient during use.

[0222] In some examples, the modules 11350-11360 may be removable from the sensor holding structures 11380-11390 so that a particular module can be switched out for another module with different functionality or to replace a module that has ceased to function or has reached end of life. For example, the modules 11350-11360 (and / or, if applicable, the circuit modules 11355, 11357, 11359, and 11361 to which they are electrically coupled) may be releasably attached to the sensor holding structures 11380-11390. To this end, the outer surfaces of the modules may form a friction fit with the interior surfaces of the walls of the sensor holding structures 11380-11390, or may form a snap fit, such as an annular snap fit or a cantilever snap fit, with the walls or other interior or exterior portions of the sensor holding structures. In some embodiments, a non-mechanical coupling, such as a magnetic coupling, may be used to retain the modules 11350-11360 within their respective sensor holding structures 11380-11390.

[0223] In some forms of the present technology, the sensor holding structures 11380-11390 may comprise pockets formed in the upper fabric portion 11310 (e.g., by cutting an incision in the outer layer 11372 or the inner layer 11370), into which the modules 11350-11360 (or their associated circuitry) can be inserted for electrical coupling with the bus 11365.

[0224] The battery module 11352 may include a rechargeable battery. The battery may be recharged, for example, by connecting to an external power source via a micro USB or USB-C port of the battery module 11352 (e.g., a port exposed through the outer fabric layer 11372) or by inductive charging. In some embodiments, the battery 11352 may be a disposable battery, for example, located within the pocket 11382 of the upper fabric portion 11310 and removable by the patient for replacement with a new battery.

[0225] 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 an associated circuit 11361 that is received in a sensor retention structure 11390. Both the actuator module 11360 and the circuit 11361 are located completely between the fabric layers 11370, 11372. In another example, the sensor module 11356 and the associated circuit 11357 may be located completely between the fabric layers 11370, 11372. One example of a sensor module 11356 that may be completely embedded is an accelerometer or gyroscope.

[0226] In some forms of the present technology, the sensor module or actuator module may be at least partially exposed. For example, a humidity sensor 11358 coupled to the circuit 11359 may be at least partially exposed to the surroundings through the outer fabric layer 11372 to measure the humidity of the patient's environment. To this end, the outer fabric layer 11372 may include an opening through which a surface of the humidity sensor 11358 may be exposed. In another example, a sensor 11354 coupled to the circuit 11355 may have its surface exposed through the inner fabric layer 11370 (e.g., through an opening formed therein) so that the sensor surface can contact the patient's skin when the positioning and stabilizing structure 11300 is worn by the patient. The sensor 11354 may be, for example, a pulse oximeter.

[0227] While the electronic components are described above as being modular and, in at least some cases, switchable for other components, in some forms of the present technology, one or more electronic components (such as sensors or actuators) may be woven or otherwise integrated into the material of the upper textile portion 11310, for example, into the outer textile layer 11372 or inner textile layer 11370, and / or into another portion of the positioning and stabilizing structure 11300, such as the lower textile portion 11320, and / or either or both of the rear portions 11306, 11308. This may allow sensors to be distributed over a wider area to provide more informative and / or accurate measurements.

[0228] In some forms of the present technology, the sensor may include a touch sensor, such as a capacitance or resistance sensor or a tactile switch, and may have associated circuitry that allows the sensor to function as a "pause" button. For example, the touch sensor may be incorporated into the positioning and stabilizing structure 11300, or an exposed area of ​​the seal-forming structure 11100. In one example, the touch sensor 11358 may be positioned in the upper fabric portion 11310 in the manner shown in FIG. 9C . The touch sensor 11358 may communicate with the processor / transceiver 11350, as described above, so that signals recorded by the touch sensor 11358 and the circuitry 11359 may be transmitted by the processor / transceiver 11350 to an external device, such as the pressure generator 4140 of the RPT device 4000.

[0229] For example, if the patient wants to leave the patient interface 11000 in place and talk, or if they wake up in the middle of the night and are feeling uncomfortable due to the positive pressure in the plenum chamber 11200, the patient may activate the "pause" sensor 11358 by light, continuous contact. The circuit 11359 may detect this contact and send a pause signal to the pressure generator 4140 (e.g., via FIG. 10C , data communication interface 4280) to immediately reduce the flow to a very low value (e.g., just enough to avoid a choking sensation). When the pause sensor 11358 is released (or reset or restarted), this is detected by the circuit 11359 and a further signal is sent to the pressure generator 4140 to reset the ramp-up algorithm implemented by the RPT device 4000.

[0230] Some forms of the present technology may include one or more sensors for determining the patient's sleep position and movement before and / or during respiratory therapy. In some forms, the determined sleep position and movement may be used to adjust the operation of the pressure generator 4140 and / or provide sensory stimuli to the patient to change their position. For example, if a number of apnea and / or hypopnea events and / or a decrease in blood oxygenation above a certain threshold is detected by one or more sensors (regardless of whether the pressure generator 4140 is currently operating), this may indicate supine sleeping. One or more actuators may receive an activation signal based on the detection, which causes the one or more actuators to generate a vibration or other tactile stimulus to sufficiently stimulate the patient to switch to a different sleep position.

[0231] For example, the positioning and stabilizing structure 11300 or the seal-forming structure 11100 may incorporate an accelerometer and / or gyroscope. The accelerometer and / or gyroscope may be fully encapsulated between the fabric layers 11370 and 11372 of the upper textile portion 11310, for example, as shown at 11360 in FIG. 9C . Both the accelerometer and gyroscope are in communication with the processor / transceiver 11350, and data recorded by them may be transmitted to the RPT device 4000 to adjust the operation of the pressure generator 4140.

[0232] Measurements recorded by the accelerometer can be used to determine the patient's sleeping position and adjust therapy accordingly. If the patient is detected sleeping on their back, therapy pressure can be slowly increased by pressure generator 4140 to prevent a sleep apnea event. If side sleeping is detected, therapy pressure can be decreased. If an upright position (e.g., reading before sleep with a mask on) is detected, the flow and pressure can be just enough to avoid a choking sensation.

[0233] Measurements recorded by the gyroscope can be used to determine patient movement and adjust therapy accordingly. If a lot of movement is detected, indicating the patient is likely waking up, therapy pressure can be kept low enough to avoid choking. When movement subsides, therapy pressure can be increased very slowly to avoid discomfort.

[0234] In some forms of the present technology, accelerometer and / or gyroscope measurements may be used to determine the patient's sleep stage and turn the pressure generator 4140 on or off accordingly. For example, starting therapy while the patient is still awake may make it difficult for the patient to fall asleep. Thus, the pressure generator 4140 may remain "off" or paused if the accelerometer and / or gyroscope measurements indicate an awake or light sleep stage, and then be switched on (typically with a gentle ramp-up) when the measurements indicate the patient is in a deep sleep stage. Conversely, if therapy has already begun and it is detected that the patient has switched from deep sleep to light sleep, such that therapy may wake the patient, the pressure generator 4140 may be paused, for example, until the patient enters deep sleep again.

[0235] In some forms of the present technology, a pulse oximeter integrated into the positioning and stabilizing structure 11300 can be used to assess sleep health. For example, a pulse oximeter 11354 and associated circuitry 11355 can be integrated into the upper fabric portion 11310 of the positioning and stabilizing structure 11300, as shown in FIG. 9C . The pulse oximeter 11354 is exposed through an opening in the inner fabric layer 11370 so that it can contact the skin on the patient's forehead. Measurements recorded by the pulse oximeter 11354 can be used to determine blood oxygen saturation levels and heart rate during the period 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 integrated to provide feedback to the patient regarding their level of health and follow-up recommendations (e.g., by a clinician).

[0236] In one example, the apnea-hypopnea index (AHI), a measure used by clinicians to classify 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 level and heart rate (e.g., measured by a PPG sensor), and chest movement (e.g., measured by an accelerometer and / or gyroscope). The AHI value can be used to determine when an "apnea" occurs.

[0237] Therefore, by tracking the AHI over time, clinicians can 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 can not only correlate apnea frequency with specific sleep positions (e.g., sleeping on their back or side), but also 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 inside the plenum chamber of the patient interface, and a nasal or full-face mask prescribed accordingly. Additionally, pressure generator 4140 settings that generate the most appropriate flow rate for the patient can be recommended based on the sensor measurements. For example, a clinician may prescribe a higher pressure setting (or equivalently, a higher flow rate) for a patient with a higher rate of apnea or hypopnea events. The prescribed flow rate may also depend on the patient's anatomy, such as if the patient's upper airway is more collapsible.

[0238] In some forms of the present technology, an EEG sensor may be provided in the positioning and stabilizing structure 11300, for example, in the upper fabric portion 11310. The EEG sensor may be partially exposed in the manner shown in module 11354 of FIG. 9C so that it can contact the skin on 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 may be transmitted (via the transceiver 11350) to an external device such as the patient's smartphone, and sleep stage, cycle, and duration information may provide feedback to the patient on how well their sleep therapy is progressing, as well as health promotion recommendations. For example, EEG sensor measurements may be used to accurately measure sleep progress, for example, to enable more accurate determination of when apneas or arousals from sleep occur during a sleep study.

[0239] In some forms of the present technology, sleep stage information may be transmitted to the RPT device 4000 so that it may be used by the pressure generator 4140 to adjust the therapy pressure to avoid arousals or disturbance events.

[0240] In some forms of the present technology, sleep stage information may be used to activate sleep-enhancing white / pink noise and / or binaural beats. These may 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 may be incorporated into the temple region of the upper fiber portion 11310.

[0241] In some forms of the present technology, the positioning and stabilizing structure 11300 may incorporate electromyogram (EMG) and / or electrooculogram (EOG) sensors. EMG and EOG sensor signals may be analyzed to determine the occurrence of REM sleep stages. As with examples incorporating EEG sensors, sleep stage information determined by EMG / EOG sensors may be used to provide feedback to the patient on how well their sleep therapy is progressing, to adjust the pressure generator 4140 to avoid arousals or disruptive events, or to activate one or more audio devices to generate sleep-enhancing noise.

[0242] At least some of the EMG / EOG sensors may be incorporated into the upper textile portion 11310. For example, a ground electrode and a reference electrode may be provided on the upper textile portion 11310, e.g., on its front section, and exposed through respective openings in the inner layer 11370 so as to be able to contact the patient's forehead. In another example, a ground electrode may be provided on the rear section 11306 of the upper textile portion 11310, or on the second lower textile portion 11308, so that the ground electrode is located behind the patient's ear in use. Additional electrodes may be provided, each having a cable attached to and / or extending through the upper textile portion 11310, the first lower textile portion 11320, or the second lower textile portion 11308, at one end and attached to an electrode patch at the other end, which can be positioned by the patient on the temple and under the eye, providing two additional measurement channels.

[0243] In some forms of the present technology, a microphone, such as a MEMS microphone or electret microphone, may be incorporated into the patient interface 11000 to detect snoring. For example, the microphone may be located in or on the interior surface of the plenum chamber 11200 adjacent the patient's nares, or on its exterior surface. The microphone may be coupled to a communication interface that enables data communication to the pressure generator 4140 of the RPT device 4000, thereby adjusting the generated pressure. For example, if a light snoring noise pattern is detected, the treatment pressure may be gradually increased to prevent a disturbance event. If the snoring noise pattern subsides, the treatment pressure may be decreased.

[0244] In some forms of the present technology, the patient interface 11000 may incorporate humidity and temperature sensors, for example on the interior surface of the plenum chamber 11200, to monitor the temperature and humidity inside the plenum chamber 11200. The sensors may be coupled to a communication interface to send humidity and temperature data to the RPT device 4000 and the humidifier 5000 to regulate their operation. The power of the pressure generator 4140 and the humidifier 5000 may be adjusted to prevent condensation buildup. For example, the humidifier 5000 may be activated in stages and / or the heater power level controlled to follow a normal air flush and still maintain a sufficient moisture level (as measured by the humidity sensor) to prevent dry mouth.

[0245] In some forms of the present technology, a pressure sensor may be provided inside the plenum chamber 11200, for example on its inner surface. This allows the air pressure inside the plenum chamber 11200 to be monitored and a signal sent to the pressure generator 4140 to dynamically adjust the pressure and flow. This may optimize the response of the pressure generator 4140 to the patient's breathing pattern.

[0246] In some forms of the present technology, a CO2 sensor may be provided inside the plenum chamber 11200. For example, the CO2 level inside the plenum chamber 11200 may be monitored. If a slight increase in CO2 level is detected, an electromechanical vent (not shown in FIGS. 9A-9C) may be opened to allow a higher flushing of air from the plenum chamber 11200. Additionally, a signal may be sent to the pressure generator 4140 to slightly increase the flow to flush out the CO2 when the CO2 level rises slightly. This may be done dynamically to minimize patient discomfort.

[0247] In some forms of the present technology, a combination of sensors and actuators may be provided to effect localized temperature changes to improve patient comfort. For example, an EEG sensor and / or pulse oximeter may be provided in the upper fabric portion 11310 (e.g., as shown at 11354 in FIG. 9C ), and a temperature sensor and / or humidity sensor may also be provided in the upper fabric portion 11310 (e.g., as shown at 11358 in FIG. 9C ). Signals from the EEG and / or PPG sensors may be analyzed to detect sleep states, and signals from the temperature and / or humidity sensors may be used to assess ambient comfort levels. One or more Peltier elements may be provided, for example, in a form wearable on a wristband, and coupled to circuitry that communicates with the EEG / PPG and temperature / humidity sensors to receive signals indicative of sleep states and ambient comfort levels, and that activates the Peltier elements to locally heat or cool the body (e.g., wrist) to help the patient maintain a comfortable sleep state.

[0248] In some forms of the present technology, a tactile feedback element (such as a small vibration motor) may be incorporated into the patient interface 11000, for example, in the temple region of the positioning and stabilizing structure 11300 (e.g., upper fiber portion 11310). The tactile feedback element may deliver vibrations to the patient to create a calming effect. For example, the processor 11350 may monitor heart rate data from a pulse oximeter 11354 and, if this exceeds a threshold, send a trigger signal to the tactile feedback element to vibrate at a heart rate a few beats lower than the patient's current heart rate to help slow it down. In another example, as described above, the tactile feedback element may be used to affect a patient's sleep position if the patient is detected to be in a sleep position that correlates with apnea or hypopnea events.

[0249] In some forms of the present technology, one or more miniature thermoelectric generators (TEGs) may be incorporated into the patient interface 11000 such that the difference between the patient's body temperature and the ambient temperature generates a potential difference that is then used to power various electronic components (sensors, actuators, processors, etc.) of the patient interface 11000. For example, the miniature TEG may be located in the top fabric portion 11310 and exposed through an opening in the inner layer 11370 so as to contact the patient's forehead.

[0250] In some forms of the present technology, multiple sensors may be combined into a single module, for example, an accelerometer and a gyroscope may be combined into a single package.

[0251] While the various sensors and actuators are described as being incorporated into the patient interface 11000 shown in Figures 9A-9C, it will be understood that they may be incorporated in a similar manner into any of the other patient interfaces 3000, 6000, 7000, 8000, 9000, 10000 disclosed herein. 5.3.4 Ventilation

[0252] In one form, the patient interface 3000 includes a vent 3400, 10400 constructed and arranged to allow for the expulsion of exhaled gases (eg, carbon dioxide).

[0253] In certain forms, the vent 3400, 10400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 3200 to the ambient when the pressure within the plenum chamber is positive relative to the ambient. The vent 3400 is configured such that the magnitude of the ventilation flow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining therapeutic pressure within the plenum chamber in use.

[0254] The ventilation section 3400, 10400 in one form according to the present technology includes a plurality of holes (eg, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0255] The vent 3400, 10400 may be located within the plenum chamber 3200, 10200. Alternatively, the vent 3400, 10400 may be located within a decoupling structure (e.g., a swivel).

[0256] In some forms, the vent 10400 may be a clear mesh with built-in vent holes.

[0257] Although not explicitly shown in Figures 4B-4D, 5A-5B, 6, 7A-7C, and 8B, it will be understood that the plenum chambers in each of the examples shown in these figures also typically include vents to allow for the flushing of CO2 and other exhaled gases.

[0258] In some forms of the present technology, the vent 3400, 10400 may be an active vent and may be activated according to sensor measurements from one or more sensors in the patient interface (e.g., the patient interface 10000). For example, in some forms, the plenum chamber 10200 may include one or more of a CO2 sensor, a temperature sensor, and a humidity sensor, and detecting one or more of these quantities above their respective thresholds may trigger the opening of the vent. 5.3.5 Decoupling Structures (Singular or Plural)

[0259] In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or a bulb). 5.3.6 Connection Port

[0260] The connection ports 3600, 6600, 7600, 8600, 9600, 10600, 11600 allow for connection to the air circuit 4170. In some examples, the connection port 11600 may be integrated with the positioning and stabilizing structure 11300, as shown, for example, in FIG.

[0261] While many different connection configurations between the air circuit 4170 and the connection ports 3600, 6600, 7600, 8600, 9600, 10600, 11600 are possible, a substantially airtight seal is formed to substantially prevent pressure leakage during treatment. As noted in connection with port 11600, a magnetic element may be located on an inner surface of the connection port for connecting to a corresponding magnetic element located on a connector on one end of the air circuit 4170. In another example, the connector of the air circuit may attach to the connection port by a snap fit (which may be either rigid-to-rigid or rigid-to-resilient, such as an annular snap fit or a cantilever snap fit) or a friction fit. 5.3.7 Forehead support

[0262] In one form, the patient interface 3000 includes a forehead support 3700 . 5.3.8 Anti-asphyxiation valve

[0263] In one form, the patient interface 3000 includes an anti-asphyxiation valve. 5.3.9 Ports

[0264] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows a property of the gas (e.g., pressure) within the plenum chamber 3200 to be directly measured. 5.4 RPT Device

[0265] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300 (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 can be configured to generate an airflow that is delivered to a patient's airway for treatment of, for example, one or more of the respiratory conditions described anywhere herein.

[0266] In one form, the RPT device 4000 is constructed and arranged to deliver airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0267] The RPT device may have an outer housing 4010. The outer housing 4010 is formed by two portions, an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0268] The air pressure path of the RPT device 4000 may include one or more air path items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) and one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0269] One or more of the air path items may be disposed within a removable, unitary structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0270] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative, the RPT device 4000 can include more than one PCBA 4202. 5.4.1 RPT Device Mechanical and Pneumatic Components

[0271] The RPT device may include one or more of the following components in an integral unit: In an alternative, one or more of the following components may be arranged as their own separate units. 5.4.1.1 Air filters

[0272] An RPT device in accordance with one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0273] In one form, the inlet air filter 4112 is located at the beginning of the air pressure path upstream of the pressure generator 4140 .

[0274] In one form, an outlet air filter 4114 (eg, an antibacterial filter) is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000. 5.4.1.2 Muffler

[0275] An RPT device in accordance with one form of the present technology may include a muffler 4120 or multiple mufflers 4120.

[0276] In one form of the present technology, an inlet muffler 4122 is located in the pneumatic path upstream of a pressure generator 4140 .

[0277] In one form of the present technology, the outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000. 5.4.1.3 Pressure generator

[0278] In one form of the present technology, the pressure generator 4140 that generates the air flow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impellers may be located within a volute. The blower may deliver the air supply at a rate of, for example, up to about 120 liters / minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O, when administering respiratory pressure therapy. The blower may be one of those described in any one of the following patents or patent applications, the contents of each of which are incorporated by reference herein 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 WO 2013 / 020167.

[0279] The pressure generator 4140 may be under the control of the therapy device controller 4240 .

[0280] In other forms, pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows. 5.4.1.4 Converters

[0281] The transducer may be internal to the RPT device or external to the RPT device. An external transducer may be located on the air circuit, for example, or may form part of the air circuit (e.g., the 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 forwards data to the RPT device.

[0282] In one form of the present technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal indicative of a characteristic of the airflow (e.g., flow rate, pressure, or temperature at that point in the pneumatic path).

[0283] In one form of the present technology, one or more transducers 4270 may be located proximate the patient interface 3000.

[0284] In one form, the signal from the converter 4270 may be filtered, for example, by low-pass, high-pass, or band-pass filtering. 5.4.1.4.1 Flow Sensor

[0285] A flow sensor 4274 according to the present technology may be based on a differential pressure transducer, for example, an SDP600 series differential pressure transducer from Sensirion Corporation.

[0286] In one form, a signal generated by the flow sensor 4274 and representative of the flow rate is received by the central controller 4230. 5.4.1.4.2 Pressure Sensor

[0287] A pressure sensor 4272 according to the present technology is located in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a Honeywell ASDX series transducer. An alternative suitable pressure sensor is a General Electric NPA series transducer.

[0288] In one form, a signal generated by the pressure sensor 4272 and representative of the pressure is received by the central controller 4230. 5.4.1.4.3 Motor Speed ​​Converter

[0289] In one form of the present technology, a motor speed transducer 4276 may be used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed transducer 4276 may be provided to the therapy device controller 4240. The motor speed transducer 4276 may be, for example, a speed sensor such as a Hall effect sensor. 5.4.1.5 Anti-spillback valves

[0290] In one form of the present technology, the anti-spillback valve 4160 may be located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000, for example, to the blower motor 4144. 5.4.2 RPT Device Electrical Components 5.4.2.1 Power supply

[0291] The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.

[0292] In one form of the present technology, the power supply 4210 powers only 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. 5.4.2.2 Input Devices

[0293] 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 or software devices accessible via a touchscreen. The buttons, switches, or dials may be physically connected to the external housing 4010 in one form, or may communicate wirelessly with a receiver in electrical communication with the central controller 4230 in another form.

[0294] In one form, the input device 4220 may be constructed and arranged to allow a person to select values ​​and / or menu options. 5.4.2.3 Central Controller

[0295] In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0296] Suitable processors may include x86 INTEL processors, such as STMicroelectronics' STM32 series microcontrollers, processors based on ARM Holdings' ARM® Cortex®-M processors, etc. In certain alternative forms of the present technology, 32-bit RISC CPUs, such as STMicroelectronics' STR9 series microcontrollers, or 16-bit RISC CPUs, such as processors in the MSP430 family of microcontrollers manufactured by Texas Instruments, are also suitable.

[0297] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0298] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0299] 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.

[0300] The central controller 4230 may be configured to provide output signals to one or more of the output device 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0301] In some forms of the present technology, the central controller 4230 is configured to implement one or more methodologies described herein, such as one or more algorithms 4300 that may be implemented in processor control instructions and expressed as a computer program stored on 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 methodologies may be performed by a remote device. For example, the remote device may determine ventilator control settings or detect respiratory-related events by analysis of stored data, such as from any of the sensors described herein. 5.4.2.4 Clock

[0302] The RPT device 4000 may include a clock 4232 connected to the central controller 4230 . 5.4.2.5 Therapy Device Controller

[0303] In one form of the present technology, the therapy device controller 4240 is a therapy control module 4330 that forms part of the algorithm 4300 executed by the central controller 4230.

[0304] In one form of the present technology, the therapy 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. 5.4.2.6 Protection circuit

[0305] The one or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits. 5.4.2.7 Memory

[0306] In accordance with one form of the present technology, the RPT device 4000 includes memory 4260, e.g., non-volatile memory. In some forms, the memory 4260 may include battery-powered static RAM. In some forms, the memory 4260 may include volatile RAM.

[0307] Memory 4260 may be located on PCBA 4202. Memory 4260 may be in the form of EEPROM or NAND flash.

[0308] Additionally or alternatively, the RPT device 4000 includes memory 4260 in a removable form, such as, for example, a memory card made in accordance with the Secure Digital (SD) standard.

[0309] In one form of the present technology, the memory 4260 functions as a non-transitory computer-readable storage medium on which are stored computer program instructions that represent one or more methodologies described herein, such as one or more algorithms 4300. 5.4.2.8 Data communication systems

[0310] In one form of the present technology, a data communications interface 4280 is provided and connected to the central controller 4230. The data communications interface 4280 may be connectable to a remote external communications network 4282 and / or a local external communications network 4284. The remote external communications network 4282 may be connectable to a remote external device 4286. The local external communications network 4284 may be connectable to a local external device 4288.

[0311] 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.

[0312] In one form, the remote external communications network 4282 is the Internet. The data communications interface 4280 connects to the Internet using wired communications (e.g., via Ethernet or fiber optics) or wireless protocols (e.g., CDMA, GSM, LTE).

[0313] In one form, the local external communications network 4284 utilizes one or more communications standards such as Bluetooth® or consumer infrared protocols.

[0314] In one form, the remote external device 4286 is one or more computers, such as, for example, a cluster of networked computers. In one form, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible to appropriately authorized personnel, such as a clinician.

[0315] The local external device 4288 may be a personal computer, a mobile phone, a tablet, or a remote control. 5.4.2.9 Any display or output device, including alarms

[0316] An output device 4290 in accordance with the present technology may take the form of one or more of a visual, auditory, and tactile unit. The visual display may be a liquid crystal display (LCD) or a light emitting diode (LED) display. 5.4.2.9.1 Display Driver

[0317] The display driver 4292 receives as input characters, symbols, or images to be displayed on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols, or images. 5.4.2.9.2 Display

[0318] Display 4294 is configured to visually display characters, symbols, or images in response to commands received from display driver 4292. For example, display 4294 may be an eight-segment display where display driver 4292 converts each letter or symbol, such as the digit "0," into eight logic signals indicating whether eight respective segments are activated to display a particular character or symbol. 5.4.3 RPT Device Algorithm

[0319] As mentioned above, in some forms of the present technology, the central controller 4230 may be configured to implement one or more algorithms 4300 expressed as a computer program stored on a non-transitory computer-readable storage medium, such as memory 4260. The algorithms 4300 are generally grouped into groups called modules.

[0320] In other forms of the present technology, part 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 such a format, data representing input signals and / or intermediate algorithm outputs necessary for the portion of the algorithm 4300 to be executed on the external device may be communicated to the external device via a local external communications network 4284 or a remote external communications network 4282. In such a format, the portion of the algorithm 4300 executed on the external device may be represented as a computer program stored on 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 the portion of the algorithm 4300.

[0321] In such a configuration, treatment parameters generated by the external device via the treatment engine module 4320 (if such form part of the portion of the algorithm 4300 executed by the external device) may be communicated to the central controller 4230 to be passed to the treatment control module 4330. 5.4.3.1 Preprocessing Module

[0322] A pre-processing module 4310 according to 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 process steps to calculate one or more output values ​​that are used as inputs to another module, e.g., a therapy engine module 4320.

[0323] In one form of the present technology, the output values ​​include interface pressure Pm, ventilation flow Qv, respiratory flow Qr, and leak flow Ql.

[0324] 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. 5.4.3.1.1 Interface Pressure Estimation

[0325] In one form of the present technology, an interface pressure estimation algorithm 4312 receives as inputs a signal from a pressure sensor 4272 indicating the pressure in the pneumatic path proximal to the outlet of the pneumatic block (device pressure Pd), and a signal from a flow sensor 4274 representing the flow rate of airflow exiting the RPT device 4000 (device flow Qd). The device flow Qd without any auxiliary gas 4180 may be used as the total flow Qt. The interface pressure algorithm 4312 estimates the pressure drop ΔP from the air circuit 4170. The dependence of the pressure drop ΔP on the total flow Qt may be modeled for a particular air circuit 4170 by a pressure drop characteristic ΔP(Q). The interface pressure estimation algorithm 4312 then provides as an output an estimated pressure Pm at the patient interface 3000. The pressure Pm at the patient interface 3000 may be estimated as the device pressure Pd minus the air circuit pressure drop ΔP. 5.4.3.1.2 Airflow rate estimation

[0326] In one form of the present technology, an airflow estimation algorithm 4314 receives as input the estimated pressure Pm of the patient interface 3000 from the interface pressure estimation algorithm 4312 and estimates the airflow Qv of air through the vent 3400 of the patient interface 3000. The dependence of the airflow Qv on the interface pressure Pm of the particular vent 3400 in use may be modeled by an airflow characteristic Qv(Pm). 5.4.3.1.3 Estimation of leakage flow rate

[0327] In one form of the present technology, a leak flow estimation algorithm 4316 receives as inputs the total flow Qt and the ventilation flow Qv and provides as an output an estimate of the leak flow Ql, hi one form, the leak flow estimation algorithm estimates the leak flow Ql by calculating the average of the difference between the total flow Qt and the ventilation flow Qv over a period long enough to include several respiratory cycles, for example, about 10 seconds.

[0328] In one form, the leak flow estimation algorithm 4316 receives as input the total flow Qt, ventilation flow Qv, and estimated pressure Pm of the patient interface 3000, calculates the leak conductance, and provides as an output the leak flow Ql by determining the leak flow Ql as a function of the leak conductance and the pressure Pm. The leak conductance is calculated as the quotient of a low-pass filtered untventilated flow equal to the difference between the total flow Qt and the ventilation flow Qv, and the low-pass filtered square root of the pressure Pm. The time constant of the low-pass filter is a value long enough to include several respiratory cycles, for example, approximately 10 seconds. The leak flow Ql may be estimated as the product of the leak conductance and a function of the pressure Pm. 5.4.3.1.4 Respiratory flow estimation

[0329] In one form of the present technology, the respiratory flow estimation algorithm 4318 receives as inputs the total flow Qt, the ventilation flow Qv, and the leak flow Ql, and estimates the respiratory flow Qr of air to the patient by subtracting the ventilation flow Qv and the leak flow Ql from the total flow Qt. 5.4.3.2 Treatment Engine Module

[0330] In one form of the present technology, the therapy engine module 4320 receives as inputs one or more of the pressure Pm at the patient interface 3000 and the respiratory flow rate Qr of air to the patient and provides one or more therapy parameters as outputs.

[0331] In one form of the present technology, the treatment parameter is the treatment pressure Pt.

[0332] In one form of the present technology, the treatment parameters are one or more of the amplitude of pressure fluctuations, base pressure, and target ventilation.

[0333] 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. 5.4.3.2.1 Phase Determination

[0334] In one form of the present technology, the RPT device 4000 does not determine the phase.

[0335] In one form of the present technology, a phase determination algorithm 4321 receives as an input a signal indicative of respiratory flow Qr and provides as an output the phase Φ of the patient's 1000 current respiratory cycle.

[0336] In some forms known as discrete phase determination, the phase output Φ is a discrete variable. One implementation of discrete phase determination provides a binary phase output Φ having a value of either inspiration or expiration, represented as values ​​of 0 and 0.5 revolutions, for example, upon detecting the onset of spontaneous inspiration and expiration, respectively. The RPT device 4000 that "triggers" and "cycles" effectively performs discrete phase determination because the trigger point and cycle point are the instants at which the phase changes from expiration to inspiration and from inspiration to expiration, respectively. In one implementation of binary phase determination, the phase output Φ is determined to have a discrete value of 0 (thereby "triggers" the RPT device 4000) when respiratory flow Qr has a value greater than a positive threshold, and a discrete value of 0.5 revolutions (thereby "cycles" the RPT device 4000) when respiratory flow Qr has a value more negative than a negative threshold. The inspiration time Ti and expiration time Te can be estimated as typical values ​​over many respiratory cycles of the time spent in phase Φ equal to 0 (indicating inspiration) and 0.5 (indicating expiration), respectively.

[0337] Another implementation of discrete phase determination provides a three-valued phase output Φ having one of the following values: inhalation, inhalation pause, and exhalation.

[0338] In another form known as continuous phase determination, the phase output Φ is a continuous variable, varying, for example, from 0 to 1 revolution, or from 0 to 2π radians. An RPT device 4000 performing continuous phase determination may trigger and cycle when the continuous phase reaches 0 revolutions and 0.5 revolutions, respectively. In one implementation of continuous phase determination, continuous values ​​of phase Φ are determined using fuzzy logic analysis of respiratory flow Qr. Continuous values ​​of phase determined in this implementation are often referred to as "fuzzy phase." In one implementation of the fuzzy phase determination algorithm 4321, the following rules are applied to respiratory flow Qr: 1. If respiratory flow is zero and increases rapidly, the phase is 0 revolutions. 2. If respiratory flow is large, positive, and stable, the phase is 0.25 revolutions. 3. If respiratory flow is zero and falls rapidly, the phase is 0.5 revolutions. 4. If respiratory flow is large and stable, the phase is 0.75 revolutions. 5. If respiratory flow is stable at zero and the 5-second low-pass filtered absolute value of respiratory flow is large, the phase is 0.9 revolutions. 6. If respiratory flow is positive and the phase is exhalation, the phase is 0 revolutions. 7. If respiratory flow is negative and the phase is inspiration, the phase is 0.5 revolutions. 8. If the 5-second low-pass filtered absolute value of respiratory flow is large, the phase is increasing at a steady rate equal to the patient's respiratory rate, low-pass filtered with a 20-second time constant.

[0339] The output of each rule can be represented as a vector where the phase is the result of the rule and the magnitude is the fuzzy range for which the rule is true. The fuzzy ranges for respiratory flow, such as "high" or "stable," are determined by appropriate membership functions. Rule results, represented as vectors, are combined with some function, such as taking the center of gravity. In such combinations, the rules may be weighted equally or differently.

[0340] In another implementation of continuous phase determination, like the inspiration time Ti and expiration time Te, the phase Φ is first discretely estimated from the respiratory flow Qr as described above. The continuous phase Φ at any time point can be determined as half the fraction of the inspiration time Ti that has elapsed since the previous trigger time point, or 0.5 revolutions plus half the fraction of the expiration time Te that has elapsed since the previous cycle time point (whichever is more recent). 5.4.3.2.2 Waveform judgment

[0341] In one form of the present technology, the therapy parameter determination algorithm 4329 provides a nearly constant therapy pressure throughout the patient's respiratory cycle.

[0342] In another form of the present technology, a therapy control module 4330 controls a 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).

[0343] In one form of the present technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ) having values ​​in the range [0, 1] on the domain of the phase value Φ provided by the phase determination algorithm 4321 for use by the treatment parameter determination algorithm 4329.

[0344] In one form suitable for either discrete or continuous-valued 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 suitable for continuous-valued phases, the waveform template Π(Φ) includes two smoothly curved sections: a smoothly curved (e.g., raised cosine) rise from 0 to 1 for phase values ​​up to 0.5 revolutions, and a smoothly curved (e.g., exponential) decay from 1 to 0 for phase values ​​greater than 0.5 revolutions. In one form suitable for continuous-valued phases, the waveform template Π(Φ) is based on a square wave having a smooth rise from 0 to 1 for phase values ​​up to a "rise time" less than 0.5 revolutions, and a smooth fall from 1 to 0 for phase values ​​within a "fall time" after 0.5 revolutions, including a "fall time" less than 0.5 revolutions.

[0345] In some forms of the present technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a library of waveform templates depending on the settings of the RPT device. Each waveform template Π(Φ) in the library is provided as a lookup table of values ​​Π versus 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, perhaps parameterized in some way by one or more parameters (e.g., the time constant of the exponential curve portion). The parameters of the functional form may be pre-determined or dependent on the current state of the patient 1000.

[0346] In some forms of the present technology, suitable for a discrete binary phase of either inspiration (Φ=0 revolutions) or expiration (Φ=0.5 revolutions), the waveform determination algorithm 4322 calculates the waveform template "on the fly" as a function of both the discrete phase Φ and the time t measured from the most recent trigger instant. In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ) in two parts (inspiration and expiration) as follows:

[0347]

number

[0348] Here, Π i (t) and Π e (t) are the inspiratory and expiratory portions of the waveform template Π(Φ,t). In one such embodiment, i (t) is the smooth rise from 0 to 1 parameterized by the rise time, and the expiratory portion of the waveform template, Π e (t) is a smooth transition from 1 to 0. 5.4.3.2.3 Ventilation assessment

[0349] In one form of the present technology, a ventilation determination algorithm 4323 receives an input of respiratory flow, Qr, and determines a measure indicative of the current patient ventilation, Vent.

[0350] In some implementations, the ventilation determination algorithm 4323 determines a measure of ventilation, Vent, that is an estimate of actual patient ventilation. In one such implementation, half the absolute value of the respiratory flow, Qr, is taken and optionally filtered with a low-pass filter, such as a second-order Bessel low-pass filter with a corner frequency of 0.11 Hz.

[0351] In other embodiments, the ventilation determination algorithm 4323 determines a measure of ventilation Vent that is broadly proportional to actual patient ventilation. One such embodiment estimates the peak respiratory flow Qpeak over the inspiratory portion of the cycle. This procedure, along with many other procedures that involve sampling the respiratory flow Qr, produces quantities that are broadly proportional to ventilation. Note that the shape of the flow waveform does not vary much (here, two breaths are considered to have a similar shape if the respiratory flow waveforms, normalized by time and amplitude, are similar). Some simple examples include the positive median respiratory flow, the median of the absolute value of the respiratory flow, and the standard deviation of the flow. Any linear combination of any order statistics of the absolute value of the respiratory flow using positive coefficients, and even those using both positive and negative coefficients, are approximately proportional to the ventilation volume. Another example is the average of the respiratory flow at the K ratio (by time) in the middle of the inspiratory portion, where 0 < K < 1. When the flow shape is constant, there are any number of quantities that are exactly proportional to ventilation. 5.4.3.2.4 Inspiratory Flow Limitation Determination

[0352] In one aspect of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 to determine the degree of inspiratory flow limitation.

[0353] In one embodiment, the inspiratory flow limitation determination algorithm 4324 receives the respiratory flow signal Qr as an input and provides, as an output, a measure of the degree to which the inspiratory portion of the breath indicates an inspiratory flow limitation.

[0354] In one form of this technology, the inspiration portion of each breath is identified by a zero-crossing detector. A number of equally spaced points (e.g., 65) representing points in time are interpolated by an interpolator along each breath's inspiration flow-time curve. The curve described by the points is then scaled by a scalar so that its length (duration / period) and area equals unity to remove the effects of changes in breathing rate and depth. The scaled breath is then compared by a comparator to a pre-stored template representing a normal, undisturbed breath, similar to the inspiration portion of the breath shown in FIG. 6A. Breaths that deviate from this template at any point during inspiration by more than a specified threshold (typically 1 scaling unit), such as those due to a cough, sigh, swallow, or hiccup, are determined by a test element and rejected. For non-rejected data, a running average of the first such scaled point is calculated by the central controller 4230 for several preceding inspiration events. This is repeated across the same inspiration event for the second such point, and so on. Thus, for example, 65 scaled data points may be generated by the central controller 4230, representing a moving average of several preceding inspiratory events, e.g., three events. This moving average of continuously updated values ​​of (e.g., 65) points is referred to hereafter as the "scaled flow rate," denoted as Qs(t). Alternatively, a single inspiratory event may be utilized rather than a moving average.

[0355] From the scaled flow rate, two shape factors relevant to determining partial blockage can be calculated.

[0356] The shape factor 1 is the ratio of the mean of the central (e.g., 32) scaled flow points to the mean of the global (e.g., 65) scaled flow points. If this ratio exceeds 1, the breath is normally occurring. If the ratio is less than or equal to 1, the breath is obstructed. A ratio of approximately 1.17 is taken as the threshold between partially obstructed and unobstructed breathing, and is equivalent to the degree of obstruction that allows the maintenance of adequate oxygenation in a typical patient.

[0357] Shape factor 2 is calculated as the RMS deviation from a scaled unit flow taken over the center (e.g., 32) points. An RMS deviation of approximately 0.2 units is considered normal. An RMS deviation of zero is considered a completely flow-limited breath. The closer the RMS deviation is to zero, the more flow-limited the breath is considered to be.

[0358] Shape factors 1 and 2 may be used alternatively or in combination. In other forms of the present technology, the number of sampled points, breaths, and midpoints may differ from those described above. Additionally, thresholds may be other than those described. 5.4.3.2.5 Apnea and hypopnea determination

[0359] In one form of the present technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 to determine the presence of apnea and / or hypopnea.

[0360] In one form, the apnea / hypopnea determination algorithm 4325 receives as an input the respiratory flow signal Qr and provides as an output a flag indicating that an apnea or hypopnea has been detected.

[0361] In one form, apnea is said to be detected when a 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 a flow intermediate between the relatively short-term average flow and the peak flow, e.g., RMS flow. The flow threshold may be a relatively long-term measure of flow.

[0362] In one embodiment, hypopnea is said to be detected if the function of respiratory flow Qr falls below a second flow threshold for a predetermined period of time. The function can determine peak flow, a relatively short-term average flow, or a flow intermediate between the relatively short-term average flow and the peak flow, e.g., RMS flow. The second flow threshold can be a relatively long-term measure of flow. The second flow threshold is greater than the flow threshold used to detect apnea. 5.4.3.2.6 Snoring detection

[0363] In one form of the present technology, the central controller 4230 executes one or more snore determination algorithms 4326 to determine the severity of snoring.

[0364] In one form, the snore determination algorithm 4326 receives as an input the respiratory flow signal Qr and provides as an output a metric of the extent to which snoring is present.

[0365] The snore determination algorithm 4326 may include determining the strength of the flow signal in the range of 30-300 Hz. Additionally, the snore determination algorithm 4326 may include filtering the respiratory flow signal Qr to reduce background noise, for example, the sound of airflow in the system from the blower. 5.4.3.2.7 Determination of airway patency

[0366] In one form of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 to determine the degree of airway patency.

[0367] In one form, the airway patency determination algorithm 4327 receives as input the respiratory flow signal Qr and determines the power of the signal in the frequency range of about 0.75 Hz to about 3 Hz. The presence of a peak in this frequency range is considered to indicate a patent airway. The absence of a peak is considered to indicate a closed airway.

[0368] In one form, the frequency range in which the peak is sought is the frequency of a small forced oscillation at the treatment pressure Pt. In one implementation, the forced oscillation has an amplitude of about 1 cmH2O and a frequency of 2 Hz.

[0369] In one form, the airway patency determination algorithm 4327 receives as input the respiratory flow signal Qr and determines the presence or absence of a cardiogenic signal, the absence of which is considered to be indicative of an obstructed airway. 5.4.3.2.8 Determining target ventilation

[0370] In one form of the present technology, the central controller 4230 runs one or more target ventilation determination algorithms 4328 to take as input the current measure of ventilation, Vent, and determine a target value for the measure of ventilation, Vtgt.

[0371] In some forms of the present technology, there is no target ventilation determination algorithm 4328, and the target value Vtgt is pre-determined, for example, by hard-coding in the configuration of the RPT device 4000 or by manual entry via the input device 4220.

[0372] In other forms of the present technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates a target value Vtgt from a value Vtyp indicative of the patient's typical recent ventilation.

[0373] In some forms of adaptive servo-ventilation, the target ventilation Vtgt is calculated to be lower than the typical current ventilation Vtyp but at a high percentage. The high percentage in such forms can be in the range (80%, 100%), or (85%, 95%), or (87%, 92%).

[0374] In other forms of adaptive servo-ventilation, the target ventilation, Vtgt, is calculated as slightly more than one time the typical recent ventilation, Vtyp.

[0375] Typical recent ventilation Vtyp is the value around which the distribution of current ventilation Vent over multiple time points over a given timescale tends to converge, i.e., it is a measure of central tendency for the current ventilation Vent over recent history. In one implementation of the target ventilation determination algorithm 4328, the recent history is on the order of minutes, but in any event should be longer than the timescale of a Cheyne-Stokes cycle. The target ventilation determination algorithm 4328 may use any of a variety of well-known measures of central tendency to determine a typical recent ventilation Vtyp from the current ventilation Vent. One such measure is the output of a low-pass filter on the current ventilation Vent with a time constant equal to 100 seconds. 5.4.3.2.9 Determination of Treatment Parameters

[0376] In some forms of the present technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 to determine one or more treatment parameters using values ​​returned by one or more of the other algorithms of the treatment engine module 4320.

[0377] 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:

[0378]

number

[0379] Here, A is the amplitude, Π(Φ,t) is the waveform template value (range 0-1) at the current value of phase Φ and time value t, ·P0 is the base pressure.

[0380] If the waveform determination algorithm 4322 provides the 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 lookup table entry closest to the current value Φ of the phase returned by the phase determination algorithm 4321, or by interpolating between two entries that span the current value Φ of the phase.

[0381] The values ​​of amplitude A and base pressure P0 may be set by the therapy parameter determination algorithm 4329 depending on the respiratory pressure therapy mode selected, in a manner described below. 5.4.3.3 Treatment Control Module

[0382] A therapy control module 4330 in accordance with one aspect of the present technology receives therapy parameters as input from a 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.

[0383] 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 an airflow such that the interface pressure Pm at the patient interface 3000 is equal to the therapy pressure Pt. 5.4.3.4 Fault Condition Detection

[0384] 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: Power failure (no power or insufficient power), Converter failure detection, -Detection failure of the presence of components, Operating parameters outside the recommended ranges (e.g., pressure, flow, temperature, PaO2), · Test alarm failure to generate a detectable alarm signal.

[0385] Upon detecting a fault condition, the corresponding algorithm 4340 signals the presence of the fault by one or more of the following: Triggering an audible, visual, and / or kinetic (e.g., vibration) alarm; Sending messages to external devices, · Recording of accidents. 5.5 Air Circuit

[0386] The air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged to allow air flow to travel between two components, such as the RPT device 4000 and the patient interface 3000, when in use.

[0387] In particular, the air circuit 4170 may be fluidly connected to the pneumatic block 4020 and the outlet of the patient interface. The air circuit may also be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0388] 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 air temperature. The heating elements may be in the form of a heated wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller, such as the central controller 4230. An example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated by reference herein in its entirety. 5.5.1 Auxiliary gas supply

[0389] In one form of the present technology, a supplemental gas 4180, e.g., oxygen, is delivered to one or more points in the pneumatic pathway, e.g., upstream of the pneumatic block 4020, the air circuit 4170, and / or the patient interface 3000. 5.6 Humidifier 5.6.1 Humidifier Overview

[0390] In one form of the present technology, a humidifier 5000 is provided (for example as shown in FIG. 11A) for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of the air stream before delivery to the patient's airways.

[0391] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 that receives an airflow, and a humidifier outlet 5004 that delivers a humidified airflow. In some forms, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively, as shown in Figures 11A and 11B. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and include a heating element 5240. 5.6.2 Humidifier components 5.6.2.1 Water reservoir

[0392] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to hold or reserve a volume of liquid (e.g., water) to evaporate for humidifying the airflow. The water reservoir 5110 is configured to hold a predetermined maximum amount of water to provide adequate humidification for at least the duration of a respiratory therapy session, such as a night's sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml. In another form, the humidifier 5000 may be configured to receive a supply of water from an external water source, such as a building's water system.

[0393] According to one embodiment, the water reservoir 5110 is configured to add humidity to the air flow as it travels therethrough from the RPT device 4000. In one form, the water reservoir 5110 may be configured to encourage the air flow to travel a tortuous path through the reservoir 5110 while in contact with the volume of water therein.

[0394] According to one form, the reservoir 5110 may be laterally removable from the humidifier 5000, for example, as shown in Figures 11A and 11B.

[0395] The reservoir 5110 may also be configured to discourage the escape of liquid therefrom, such as when the reservoir 5110 is displaced and / or rotated from its normal working orientation, such as through any openings and / or between its subcomponents. Because the air stream to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent loss of air pressure due to leakage and / or flow impedance. 5.6.2.2 Conductive parts

[0396] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the volume of liquid within the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, although other shapes may be suitable. All or part of the conductive portion 5120 may be made of a thermally conductive material such as aluminum (e.g., approximately 2 mm thick, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastic. In some cases, a less conductive material in an appropriate shape may be used to achieve adequate thermal conductivity. 5.6.2.3 Humidifier Reservoir Dock

[0397] In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in FIG. 11B ) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may include a locking feature, such as a locking lever 5135 configured to retain the reservoir 5110 within the humidifier reservoir dock 5130. 5.6.2.4 Water Level Indicator

[0398] The humidifier reservoir 5110 may include a water level indicator 5150, as shown in Figures 11A-11B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as the patient 1000 or a caregiver, regarding the amount of volume of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of a maximum predetermined amount of water, any fraction thereof, such as 25%, 50%, or 75%, or a volume, such as 200 ml, 300 ml, or 400 ml. 5.6.2.5 Humidifier Converter

[0399] The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of, or in addition to, the transducer 4270 described above. The humidifier transducer 5210 may include one or more of an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218, as shown in FIG. 11C . The humidifier transducer 5210 may generate one or more output signals that may be communicated to a controller, such as the central controller 4230 and / or the humidifier controller 5250. In some forms, the humidifier transducer may be located external to the humidifier 5000 (such as in the air circuit 4170) while communicating the output signal to the controller. 5.6.2.5.1 Pressure Transducers

[0400] In addition to, or instead of, the pressure sensor 4272 provided in the RPT device 4000, one or more pressure transducers 5212 may be provided in the humidifier 5000. 5.6.2.5.2 Flow Converter

[0401] In addition to, or instead of, the flow sensor 4274 provided in the RPT device 4000, one or more flow transducers 5214 may be provided in the humidifier 5000. 5.6.2.5.3 Temperature Converter

[0402] The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures, such as the heating element 5240 and / or the airflow downstream of the humidifier outlet 5004. In some forms, the humidifier 5000 may further include a temperature sensor 5216 that detects the temperature of the ambient air. 5.6.2.5.4 Humidity Converter

[0403] In one form, the humidifier 5000 may include one or more humidity sensors 5218 to detect the humidity of a gas, such as ambient air. The humidity sensor 5218 may be mounted toward the humidifier outlet 5004 in some forms 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. 5.6.2.6 Heating elements

[0404] A heating element 5240 may optionally be provided in the humidifier 5000 to provide heat input to one or more of the volume of water in the humidifier reservoir 5110 and / or the airflow. The heating element 5240 may include a heat-generating component such as an electrical resistive heating track. One suitable example of a heating element 5240 is a layered heating element such as that described in WO 2012 / 171072, the entire contents of which are incorporated herein by reference.

[0405] In some forms, the heating element 5240 may be provided within the humidifier base 5006, where heat may be provided to the humidifier reservoir 5110 primarily by conduction, as shown in FIG. 11B. 5.6.2.7 Humidifier Controller

[0406] According to one arrangement of the present technology, the humidifier 5000 may include a humidifier controller 5250, as shown in Figure 11C. In one form, the humidifier controller 5250 may be part of the central controller 4230. In another form, the humidifier controller 5250 may be a separate controller that may be in communication with the central controller 4230.

[0407] In one form, the humidifier controller 5250 may receive as inputs, for example, measures of airflow, water in the reservoir 5110, and / or characteristics of the humidifier 5000 (such as temperature, humidity, pressure, and / or flow rate). The humidifier controller 5250 may also be configured to run or implement a humidifier algorithm and / or deliver one or more output signals.

[0408] As shown in FIG. 11C , 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 configured to control the temperature of the heating element 5240. 5.7 Screening, diagnostic, and surveillance systems 5.7.1 Overview

[0409] At least some forms of the present technology enable screening, diagnosing, and / or monitoring sleep health using sensors integrated into the patient interface. The sensors may be provided in the positioning and stabilizing structure of the patient interface, such as the positioning and stabilizing structure 11300 of Figures 9A and 9B, and / or in the plenum chamber of the patient interface.

[0410] For example, as mentioned, a sensor-enabled positioning and stabilizing structure in the form of a headband, such as positioning and stabilizing structure 6300 or 11300, may be worn by the patient before initiating treatment, and sensor measurements may be recorded during sleep. The sensor measurements may be used to accurately monitor sleep stages and sleep position, track vital signs and other physiological indicators, and detect apnea and / or hypopnea events. The sleep and physiological data may be used by clinicians to diagnose sleep disorders and recommend appropriate treatments. Furthermore, the same parameters may be monitored by sensors during treatment and compared to those before treatment began (or in the early stages of treatment) to enable the patient and clinician to evaluate the effectiveness of the treatment.

[0411] As mentioned, physiological and sleep data may be recorded by one or more sensors in the patient interface and communicated to an external computing device, such as the patient's smartphone and / or a monitoring server operated by or accessible by a clinician or other healthcare provider.

[0412] In some forms of the present technology, a pulse oximeter integrated into the positioning and stabilizing structure 11300 can be used to determine blood oxygen saturation levels and heart rate during the period the patient interface 11000 is worn, and this data can be transmitted to an external computing device such as the patient's smartphone, other mobile computing device, or the patient's laptop or desktop computing system. The data can include time series data that can be integrated to provide the patient with feedback regarding their health level and follow-up recommendations (e.g., by a clinician). This can be based on the AHI determination described above, which can be used in combination with other sensor measurements to determine, for example, when and how frequently apneic events are occurring. The data can further be used to devise optimal treatments for the patient.

[0413] Other sensors that may be incorporated into a screening, diagnostic, and / or monitoring system that includes a sensor-enabled patient interface include, without limitation: EEG sensors for detecting sleep stages, EMG and EOG sensors for determining the occurrence of REM sleep stages, microphones for detecting snoring or other sounds indicative of sleep disturbances, humidity sensors, temperature sensors, pressure sensors, and / or CO2 sensors each located inside the plenum chamber 11200 of the patient interface.

[0414] Several applications of sensor-enabled patient interfaces are described. 5.7.2 Polysomnography

[0415] Polysomnography (PSG) is a monitoring process that typically requires a variety of different sensors and associated equipment and can be difficult to set up, even for experts. A typical PSG system includes a headbox that receives and records signals from the following sensors: EOG electrodes, EEG electrodes, ECG electrodes, submental EMG electrodes, a snoring sensor, a chest band respiratory inductance plethysmogram (respiratory effort sensor), an abdominal band respiratory inductance plethysmogram (respiratory effort sensor), an oronasal cannula with an oral thermistor, a photoplethysmograph (pulse oximeter), and a body position sensor. The electrical signal is referenced to a ground electrode (ISOG) positioned in the center of the forehead.

[0416] A sensor-enabled patient interface such as patient interface 11000 may replace some or all of the functionality of an existing PSG system, and as described above, some or all of the sensors used by the PSG system may be provided in the positioning and stabilizing structure (e.g., 11300) and / or plenum chamber (e.g., 11200). For example, EOG, EEG, ECG, and EMG electrodes, a microphone (acting as a snoring sensor), a PPG sensor, and an accelerometer and / or gyroscope (acting as a position sensor) may all be provided in the upper fabric portion 11310 and / or the lower fabric portions 11308, 11320 of the positioning and stabilizing structure 11300. A ground electrode may also be provided (e.g., in the lower fabric portion 11308 for placement behind the patient's ear, as described above).

[0417] Integrating the sensors with the patient interface 11000 makes implementing PSG much easier, as, at least in some instances, the patient can simply wear the patient interface 11000 in the manner they have been treated up to this point, with no or minimal additional configuration required (e.g., without the need to manually place various electrodes for the sensors). 5.7.3 Unintrusive monitoring system

[0418] 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 representative of the patient's bodily movements, from which a signal representative of the patient's respiratory movements can be derived. 5.7.4 Respiratory polygraphy

[0419] Respiratory polygraphy (RPG) is a term used to describe a simplified form of PSG without electrical signal (EOG, EEG, EMG) sensors, snoring sensors, or body position sensors. Typically, an RPG includes at least a chest motion signal from a respiratory inductance plethysmogram (motion sensor) on a chest band, a nasal pressure signal sensed via a nasal cannula, and an oxygen saturation signal from a pulse oximeter, e.g., a pulse oximeter. Three RPG signals, or channels, are received by the RPG headbox.

[0420] A sensor-enabled patient interface, such as the patient interface 11000, may replace some or all of the functionality of an existing RPG system. For example, accelerometer and / or gyroscope measurements from sensors attached to the headgear 11300 may be used as a proxy for the chest motion signal. The nasal pressure signal may be measured by a pressure sensor attached inside the plenum chamber, e.g., to the interior surface of the plenum chamber, so as to be placed adjacent to the patient's nares during use. The oxygen saturation signal may be measured by a PPG sensor attached to the headgear 11300, for example, as shown at 11355 in FIG. 9C. The proxy chest motion signal, nasal pressure signal, and oxygen saturation signal may be received by the on-board processor 11350 of the patient interface 11000 and / or transmitted to an external computing device for analysis in the same manner as conventional RPG signals.

[0421] In certain configurations, the nasal pressure signal is a sufficient proxy for the nasal flow signal generated by a sealed nasal mask and an in-line flow transducer in that the nasal pressure signal is similar in shape to the nasal flow signal. Similarly, nasal flow is equal to the respiratory flow rate when the patient's mouth remains closed, i.e., there is no mouth leakage. 5.8 Portable Oxygen Concentrators (POC)

[0422] Portable oxygen concentrators may utilize pressure swing adsorption (PSA). In pressure swing adsorption, one or more compressors may be used to increase the gas pressure within a canister containing particles of a gas separation adsorbent contained within a "sieve bed." As the pressure increases, certain molecules in the gas may be adsorbed onto the gas separation adsorbent. When a portion of the gas in the canister is removed under pressurized conditions, the non-adsorbed molecules are separated from the adsorbed molecules. The gas separation adsorbent may be regenerated by reducing the pressure, thereby reversing the molecular adsorption from the adsorbent. Further details regarding oxygen concentrators may be found, for example, in U.S. Patent Application Publication No. 2009-0065007, entitled "Oxygen Concentrator and Method," published March 12, 2009, which is incorporated herein by reference.

[0423] Ambient air typically contains approximately 78% nitrogen and 21% oxygen, with the balance being argon, carbon dioxide, water vapor, and other trace gases. When a gas mixture, such as air, is passed under pressure through a canister containing a gas separation adsorbent bed that adsorbs nitrogen more than oxygen, some or all of the nitrogen remains in the bed, and the gas exiting the canister is oxygen-enriched. When the bed reaches the limit of its nitrogen adsorption capacity, the bed can be regenerated by reducing the pressure, thereby releasing the adsorbed nitrogen. The system is then ready for another oxygen-enriched air generation cycle. By alternating between canisters in a two-canister system, oxygen is separated through one canister while the other is purged (resulting in continuous oxygen separation from nitrogen). In this manner, oxygen-enriched air can be accumulated, for example, in a storage container or other pressurizable vessel or conduit connected to the canister for a variety of uses, such as providing supplemental oxygen to patients. 5.9 Respiratory Therapy Mode

[0424] A variety of respiratory therapy modes can be implemented by the disclosed respiratory therapy system. 5.9.1 CPAP therapy

[0425] In some implementations of respiratory pressure therapy, the central controller 4230 sets the therapy pressure Pt according to the therapy pressure equation (1) as part of the therapy parameter determination algorithm 4329. In one such implementation, the amplitude A is equal to zero, so that the therapy pressure Pt (which represents the target value currently achieved by the interface pressure Pm) is exactly equal to the base pressure P0 for the entire 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 waveform template Π(Φ).

[0426] In CPAP therapy, the base pressure P0 may be a constant value hard-coded or manually entered into the RPT device 4000. Alternatively, the central controller 4230 may iteratively calculate the base pressure P0 as a function of a sleep disordered breathing index or measure returned by the respective algorithm of the therapy engine module 4320, such as one or more of flow limitation, apnea, hypopnea, patency, and snoring. This alternative is sometimes referred to as APAP therapy.

[0427] FIG. 10E is a flow chart illustrating a method 4500 executed by the central controller 4230 for continuously calculating the base pressure P0 as part of an APAP therapy implementation of the therapy parameter determination algorithm 4329 when pressure support A is equal to zero.

[0428] Method 4500 begins at step 4520, in which the central controller 4230 compares the measure of the presence of apnea / hypopnea to a first threshold to determine whether the measure of the presence of apnea / hypopnea exceeds the first threshold for a predetermined period of time, indicating that apnea / hypopnea is occurring. If so, method 4500 proceeds to step 4540; if not, 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 a patent airway, the detected apnea / hypopnea is deemed to be central and method 4500 proceeds to step 4560; otherwise, the apnea / hypopnea is deemed to be obstructive and method 4500 proceeds to step 4550.

[0429] The central controller 4230 compares the measure of flow limitation to a third threshold in step 4530. If the measure of flow limitation exceeds the third threshold, which indicates that the inspiratory flow is limited, the method 4500 proceeds to step 4550;

[0430] In step 4550, the central controller 4230 increases the base pressure P by a predetermined pressure increment ΔP, but the resulting therapeutic pressure P does not exceed the maximum therapeutic pressure P. In one implementation, the predetermined pressure increment ΔP and the maximum therapeutic pressure P are 1 cmH2O and 25 cmH2O, respectively. In other implementations, the pressure increment ΔP may be as low as 0.1 cmH2O and as high as 3 cmH2O, or as low as 0.5 cmH2O and as high as 2 cmH2O. In other implementations, the maximum therapeutic pressure P may be as low as 15 cmH2O and as high as 35 cmH2O, or as low as 20 cmH2O and as high as 30 cmH2O. The method 4500 then returns to step 4520.

[0431] In step 4560, the central controller 4230 decreases the base pressure P by a decrement, but the decreased base pressure P does not fall below the minimum therapeutic pressure P. The method 4500 then returns to step 4520. In one implementation, the decrement is proportional to the value of P minus P, so that the decrease in P to the minimum therapeutic pressure P when no events are detected is exponential. In one implementation, the proportionality constant is set so that the time constant τ of the exponential decrease in P is 60 minutes and the minimum therapeutic pressure P is 4 cmH2O. In other implementations, the time constant τ may be as low as 1 minute, as high as 300 minutes, or as low as 5 minutes, or as high as 180 minutes. In other implementations, the minimum therapeutic pressure P may be as low as 0 cmH2O, as high as 8 cmH2O, or as low as 2 cmH2O, or as high as 6 cmH2O. Alternatively, the decrement of P0 can be predetermined so that the decrease of P0 to the minimum therapeutic pressure Pmin is linear if no event is detected. 5.9.2 Bilevel therapy

[0432] In other implementations of the present technology, the value of the amplitude A in equation (1) can be positive. When equation (1) with a positive amplitude A is used to determine the therapeutic pressure Pt, such implementations are known as bilevel therapy because the therapy parameter determination algorithm 4329 varies the therapeutic pressure Pt between two values ​​or levels in synchronization with the spontaneous breathing efforts of the patient 1000. That is, based on the exemplary waveform template Π(Φ,t) described above, the therapy parameter determination algorithm 4329 increases the therapeutic pressure Pt to P0+A (known as IPAP) at the beginning of or during inspiration and decreases the therapeutic pressure Pt to the base pressure P0 (known as EPAP) at the beginning of or during expiration.

[0433] In some forms of bilevel therapy, IPAP is the therapeutic pressure with the same purpose as the therapeutic pressure in CPAP therapy mode, and EPAP is IPAP minus amplitude A, which has a "small" value (a few cmH2O) sometimes referred to as expiratory pressure relief (EPR). Such forms are sometimes referred to as CPAP therapy with EPR and are generally considered more comfortable than straight CPAP therapy. In CPAP therapy with EPR, either or both of IPAP and EPAP may be constant values ​​hard-coded into the RPT device 4000 or manually entered. Alternatively, the therapy parameter determination algorithm 4329 may iteratively calculate IPAP and / or EPAP during CPAP with EPR. In this alternative, the therapy parameter determination algorithm 4329 iteratively calculates EPAP and / or IPAP as a function of the sleep disordered breathing index or measure returned by the respective algorithm in the therapy engine module 4320, in a manner similar to the calculation of base pressure P0 in APAP therapy described above.

[0434] In other forms of bilevel therapy, the amplitude A is large enough that the RPT device 4000 performs some or all of the work of breathing for the patient 1000. In these forms, known as pressure support ventilation, the amplitude A is referred to as pressure support or swing. In pressure support ventilation, IPAP is a base pressure P0 plus pressure support A, and EPAP is the base pressure P0.

[0435] In some forms of pressure support ventilation therapy, known as fixed pressure support ventilation therapy, the pressure support A is fixed at a predetermined value, for example, 10 cmH 0. The predetermined pressure support value is a setting of the RPT device 4000 and may be set, for example, by hard coding during configuration of the RPT device 4000 or by manual entry via the input device 4220.

[0436] In another form of pressure-support ventilation, commonly known as servo-ventilation, the therapy parameter determination algorithm 4329 receives as input some currently measured or estimated parameter of the respiratory cycle (e.g., the current measurement of ventilation, Vent) and a target value for that respiratory parameter (e.g., the target value of ventilation, Vtgt), and iteratively adjusts the parameters of equation (1) to bring the current measurement of the respiratory parameter to the target value. In a form of servo-ventilation known as adaptive servo-ventilation (ASV), which has been used to treat CSR, the respiratory parameter is ventilation, and the target ventilation, Vtgt, is calculated by the target ventilation determination algorithm 4328 from the typical recent ventilation, Vtyp, described above.

[0437] In some forms of servo-ventilation, the therapy parameter determination algorithm 4329 applies a control methodology to iteratively calculate pressure support A to bring the current measurement of the respiratory parameter to the target value. One such control method is proportional-integral (PI) control. In one implementation of PI control suitable for ASV mode, where the target ventilation Vtgt is set slightly lower than the typical recent ventilation Vtyp, pressure support A is iteratively calculated as follows:

[0438]

number

[0439] where G is the gain of the PI control. Larger values ​​of gain G may result in positive feedback in the therapy engine module 4320. Smaller values ​​of gain G may result in 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 may vary between treatment sessions, starting small and increasing with each session until it reaches a value that substantially eliminates CSR. Conventional means for retrospectively analyzing parameters of a treatment session to assess the severity of CSR during the treatment session may be applied in such implementations. In yet other implementations, gain G may vary depending on the difference between the current measured ventilation, Vent, and the target ventilation, Vtgt.

[0440] Other servo-ventilation control methodologies that may be applied by the therapy parameter determination algorithm 4329 include proportional (P), proportional-derivative (PD), and proportional-integral-derivative (PID).

[0441] The value of pressure support A calculated via equation (2) may be limited to a range defined as [Amin, Amax]. In this implementation, pressure support A defaults to the minimum pressure support Amin until the current ventilation Vent is measured below the target ventilation Vtgt, at which point A begins to increase, returning to Amin only when Vent again exceeds Vtgt.

[0442] The pressure assist limits Amin and Amax are settings of the RPT device 4000 and are set, for example, by hard coding during configuration of the RPT device 4000 or by manual entry via the input device 4220.

[0443] In pressure support ventilation therapy mode, the EPAP is the base pressure P0. Similar to the base pressure P0 in CPAP therapy, the EPAP can be a constant value defined or determined during titration. 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. Titration of the EPAP for a particular patient can be performed by a clinician during a titration session with the aid of PSG to prevent obstructive apnea, thereby maintaining an open airway for pressure support ventilation therapy in a manner similar to titrating the base pressure P0 in constant CPAP therapy.

[0444] Alternatively, the therapy parameter determination algorithm 4329 may repeatedly calculate the base pressure P during pressure support ventilation therapy. In such an implementation, the therapy parameter determination algorithm 4329 repeatedly calculates EPAP as a function of a sleep-disordered breathing index or measure returned by each algorithm of the therapy engine module 4320, such as one or more of flow limitation, apnea, hypopnea, patency, and snoring. Because the continuous calculation of EPAP is similar to the clinician's manual adjustment of EPAP during EPAP titration, this process is also referred to as auto-titration of EPAP, and the therapy mode is known as auto-titration EPAP pressure support ventilation therapy or automatic EPAP pressure support ventilation therapy. 5.10 Glossary

[0445] For purposes of this disclosure, in certain aspects of the technology, one or more of the following definitions may apply. In other aspects of the technology, other definitions may apply. 5.10.1 General

[0446] Air: In certain forms of the present technology, air may refer to atmospheric air; in other forms of the present technology, air may refer to combinations of other breathable gases (e.g., oxygen-enriched air).

[0447] Atmosphere: In certain forms of the present technology, the term "atmosphere" should be taken to mean (i) that which is external to the treatment system or patient, and (ii) that which immediately surrounds the treatment system or patient.

[0448] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping), which may differ from the humidity outside the room where the patient is sleeping.

[0449] In another example, the ambient pressure may be the pressure immediately surrounding or external to the body.

[0450] In certain embodiments, ambient (e.g., acoustic) noise can be considered the background noise level in the room the patient is in, other than noise emanating from, for example, the RPT device or from the mask or patient interface. Ambient noise can originate from sources outside the room.

[0451] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy that can automatically adjust the therapeutic pressure between minimum and maximum limits, for example, between breaths, depending on the presence or absence of signs of an SDB episode.

[0452] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airways increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to the detection of an indication of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0453] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, reference to flow rate refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, reference to flow rate refers to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be given the symbol Q. "Flow rate" may also be called "flow" or "airflow" for shorthand.

[0454] In the example of patient breathing, the flow rate may be nominally positive for the inspiratory portion of the patient's respiratory cycle, and therefore negative for the expiratory portion of the patient's respiratory cycle. The device flow rate Qd is the flow rate of air exiting the RPT device. The total flow rate Qt is the flow rate of air and any auxiliary gases that reach the patient interface via the air circuit. The ventilator flow rate Qv is the flow rate of air exiting the vent to allow for the expulsion of exhaled gases. The leakage flow rate Ql is the flow rate of leakage 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.

[0455] Flow Therapy: Respiratory therapy that involves delivering airflow to the airway entrance at a controlled flow rate, referred to as therapeutic flow, that is usually positive throughout the patient's respiratory cycle.

[0456] Humidifier: The word "humidifier" is construed to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air stream to improve the medical respiratory condition of a patient.

[0457] Leakage: The term "leakage" refers to unintended airflow. In one example, a leak can occur due to an imperfect seal between the mask and the patient's face. In another example, a leak can occur at the swivel elbow to the perimeter.

[0458] Noise Conduction (Acoustic): In this document, conducted noise refers to noise that is carried to the patient by the pneumatic pathway (e.g., 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.

[0459] Noise Emission (Acoustic): In this document, radiated noise refers to noise carried by the ambient air to the patient. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the target in accordance with ISO 3744.

[0460] Ventilation noise (acoustic): In this document, ventilation noise refers to the noise generated by airflow through any ventilation (eg, vents in the patient interface).

[0461] Oxygen-enriched air: Air having an oxygen concentration higher than that of atmospheric air (21%) (e.g., 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-enriched air" may also be simply referred to as "oxygen."

[0462] Medical Oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or greater.

[0463] Patient: A person with or without a respiratory disease.

[0464] Pressure: Force per unit area. Pressure can be expressed in a variety of units (e.g., cmH2O, gf / cm 2 , and hectopascals). 1cmH2O is 1g-f / cm 2 is equal to approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m 2= 1 millibar to 0.001 atm). In this specification, pressures are given in units of cmH2O unless otherwise specified.

[0465] The pressure in the patient interface is designated by the symbol Pm, and the therapeutic pressure, which represents the target value that the interface pressure Pm should reach at this time, is designated by the symbol Pt.

[0466] Respiratory pressure therapy: the application to the airway entrance of an air supply at a therapeutic pressure that is typically positive relative to the atmosphere.

[0467] Ventilator: A mechanical device that provides pressure support to a patient while they perform some or all of the work of breathing. 5.10.1.1 Materials

[0468] Silicone or silicone elastomer: Synthetic rubber. References to silicone herein refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (in a family of products sold under this registered trademark) manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness of about 35 to about 45, as measured by ASTM D2240-15e1.

[0469] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0470] Fiber: A flexible material formed from a network of fibers, which may be natural, artificial, or a combination thereof. Fibers (e.g., wool, flax, cotton, hemp, and / or man-made fibers) may be woven, knitted, crocheted, knotted, tatted, felted, and / or spun into yarns to form fabrics. As used herein, the terms "fiber" and "fabric" are interchangeable. 5.10.1.2 Mechanical properties

[0471] Resilience: The ability of a material to absorb energy during elastic deformation and to release the energy upon unloading.

[0472] Resilient: Releases substantially all of its energy upon unloading. Examples include certain silicone and thermoplastic elastomers.

[0473] 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). "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may easily deform under finger pressure, for example. "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and do not easily deform under finger pressure, for example.

[0474] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment, e.g., compression, extension, bending, or torsion. A structure or component may offer different resistance in different directions. The antonym of stiffness is flexibility.

[0475] Floppy structure or component: A structure or component that changes shape, e.g., flexes, when forced to support its own weight over a relatively short period of time, e.g., within one second.

[0476] 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 an application would be setting up and maintaining a patient interface in a sealed manner against a patient airway entrance under a pressure load of, for example, approximately 20-30 cmH2O.

[0477] As an example, an I-beam may have a different bending stiffness (resistance to bending load) in a first direction compared to a second, orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction. 5.10.2 Breathing Cycle

[0478] Apnea: According to some definitions, apnea is said to occur when flow below a predetermined threshold continues for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when some airway obstruction does not allow airflow despite patient effort. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0479] Respiratory rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0480] Duty cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0481] Exercise (Respiration): Respiratory effort is said to refer to the movement made by the spontaneous breathing of a person trying to breathe.

[0482] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0483] Flow limitation: Flow limitation is understood to be a condition in a patient's breathing where an increase in patient effort does not result in a corresponding increase in flow. If flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0484] Flow-limited inspiration waveform types: (i) Flattening: An upswing followed by a relatively flat area, followed by a downswing. (ii) M-shaped: has two local peaks, one at the rising edge and one at the falling edge, with a relatively flat region between these two peaks. (iii) Chair-like: has a single local peak that occurs at the rising edge and is followed by a relatively flat region. (iv) Inverted chair: A relatively flat region followed by a single local peak, which occurs at the trailing edge.

[0485] Hypopnea: By some definitions, hypopnea refers to a reduction in flow, rather than an interruption of flow. In one form, hypopnea is said to occur when a reduction in flow below a threshold rate continues for a sustained period. When hypopnea is detected due to a decrease in respiratory effort, central hypopnea is said to occur. In one form in adults, any of the following may be considered hypopnea: (i) A 30% decrease in patient respiration for at least 10 seconds plus an associated 4% desaturation, or (ii) A reduction in patient respiration (less than 50%) lasting at least 10 seconds and associated desaturation of at least 3% or arousal occurs.

[0486] Hyperventilation: An increase in flow to a level higher than normal.

[0487] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0488] Patency (Airway): The degree to which the airway is open or the extent to which it is open. Airway patency is an opening. Airway patency can be quantified, for example, with a value of 1 indicating open and a value of 0 indicating closed (obstructed).

[0489] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.

[0490] Peak flow (Q peak): The maximum value of the flow rate during the inspiratory portion of the respiratory flow waveform.

[0491] Respiratory airflow, patient airflow, respiratory airflow (Qr): These terms may be understood to refer to the RPT device's estimate of respiratory airflow, and are used in contrast to "true respiratory flow" or "true respiratory airflow," which is the patient's actual respiratory flow, usually expressed in liters per minute.

[0492] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without extra effort. In principle, the inhaled volume Vi (volume of air inhaled) is equal to the exhaled volume Ve (volume of air exhaled), so a single tidal volume Vt can be defined as equal to either volume. In practice, the tidal volume Vt is estimated as some combination (e.g., the average of the inhaled volume Vi and the exhaled volume Ve).

[0493] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0494] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0495] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0496] Typical Recent Ventilation: The ventilation value around which recent values ​​of ventilationVent over a given timescale tend to cluster (i.e., the degree to which recent values ​​of ventilation tend to be central).

[0497] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. May be associated with a state of flow limitation in which flow may increase or decrease slightly with increasing pressure differential across the upper airway (Starling resistor behavior).

[0498] Vent: A measure of the rate of gas exchange performed by a patient's respiratory system. Measurements of ventilation may 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 as volume per minute. 5.10.3 Ventilation

[0499] Adaptive Servo Ventilator (ASV): A servo ventilator that does not have a fixed target ventilation but is variable. The variable target ventilation can be learned from some characteristics of the patient (e.g., the patient's breathing characteristics).

[0500] Backup Rate: A ventilator parameter that establishes the minimum respiratory rate (typically in breaths per minute) that will be delivered to the patient by the ventilator (when not triggered by spontaneous breathing efforts).

[0501] Cycle: The end of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop breath delivery.

[0502] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressures are added within a breath to produce the desired interface pressure that the ventilator attempts to achieve at a given moment.

[0503] End Expiratory Pressure (EEP): The desired interface pressure that the ventilator attempts to achieve at the end of the expiratory portion of the breath. If the pressure waveform template Π(Φ) has a value of zero at the end of expiration (i.e., Π(Φ)=0 when Φ=1), then EEP is equal to EPAP.

[0504] Inspiratory Positive Airway Pressure (IPAP): The maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0505] Pressure Support: A number indicating the increase in pressure during ventilator inspiration compared to the corresponding ventilator expiration, and refers primarily to the pressure difference between the maximum inspiratory pressure and the base pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure support refers to the difference the ventilator attempts to achieve (rather than the difference it actually achieves).

[0506] Servo-ventilator: A ventilator that measures patient ventilation and has a target ventilation, adjusting the level of pressure support to bring patient ventilation closer to the target ventilation.

[0507] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath in a spontaneously breathing patient. However, if the device fails to detect a breath within a predetermined period of time, the device automatically begins breath delivery.

[0508] Swing: A term equivalent to pressure assistance.

[0509] Triggered: When a ventilator or other respiratory treatment 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 occurs when, before, or after the patient initiates the breathing portion of the respiratory cycle. 5.10.4 Anatomy 5.10.4.1 Facial Anatomy

[0510] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0511] Wing angle:

[0512] Alare: The outermost point on the ala of the nose.

[0513] Alar curvature (or alar crest) point: The most posterior point on the curved baseline of each alar, found in the crease formed by the union of the alar and cheek.

[0514] Pinna: the entire visible part of the ear.

[0515] (Nasal) skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0516] (Nasal) cartilaginous rami: The cartilaginous rami of the nose include the septal cartilage, lateral cartilage, greater cartilage, and lesser cartilage.

[0517] Columella: The piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0518] Columella angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort horizontal and crossing the subnasal point.

[0519] Frankfort horizontal plane: A line extending from the most inferior point of the orbital rim to the left auricular point, which is the deepest point of the auricle from the superior side of the notch to the tragus.

[0520] Glabellar: Located in the soft tissue, the most prominent point in the midsagittal plane of the forehead.

[0521] Lateral nasal cartilage: a generally triangular plate of cartilage whose upper margin is attached to the nasal bone and the frontal process of the maxilla, and whose lower margin is connected to the greater alar cartilage.

[0522] Lip, lower side (lower lip: labrale inferius):

[0523] Lip, upper side (upper lip: labrale superius):

[0524] Greater alar cartilage: a cartilaginous plate beneath the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is attached to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.

[0525] Nostrils (nares): Generally ellipsoidal alar openings that form the entrance to the nasal cavity. The singular form of nostrils is naris (nose hole). These nostrils are separated by the nasal septum.

[0526] Nasolabial fold or nasolabial crease: a fold or groove of skin that extends from each side of the nose to the corners of the mouth, separating the cheek from the upper lip.

[0527] Nasolabial angle: the angle between the columella and upper lip, crossing the subnasal point.

[0528] Inferior ear point: The lowest point where the auricle attaches to the facial skin.

[0529] Superior auricular point: the highest point of attachment of the pinna to the facial skin.

[0530] Nasal tip: The most prominent point or tip of the nose, which can be seen in a lateral view of the rest of the head.

[0531] Philtrum: midline groove extending from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0532] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0533] Nasal ridge: The nasal ridge is the midline prominence of the nose, extending from the serion to the apex.

[0534] Sagittal plane: A vertical plane running from anterior (front) to posterior (rear). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0535] Therion: It is the most concave point on the area of ​​the frontonasal suture, located on the soft tissue.

[0536] Septal cartilage (nose): The nasal septum cartilage is part of the septum, which divides the anterior part of the nasal cavity.

[0537] Nasal alar nasal basin: the point on the lower periphery of the alar base where it joins with the skin of the upper (top) lip.

[0538] Subnasal point: Located on the soft tissue, the point where the columella joins the upper lip in the midsagittal plane.

[0539] Supramenton: The most concave point in the midline of the lower lip between the lower lip midpoint and the soft tissue pogonion. 5.10.4.2 Skull anatomy

[0540] Frontal bone: The frontal bone contains the squama frontalis, a large vertical portion that corresponds to the area known as the forehead.

[0541] Mandible: The mandible forms the lower jaw. The mental protuberance is a bony protuberance in the jaw, forming the chin.

[0542] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the orbit. The frontal process of the maxilla projects upward by the sides of the nose and forms part of its lateral border.

[0543] Nasal bones: The nasal bones are two small, rectangular bones that vary in size and shape from person to person. They lie side by side in the middle and upper parts of the face, and their junction forms the "bridge" of the nose.

[0544] Nasion: the intersection of the frontal bone and the two nasal bones, a concave area directly between the eyes and the upper side of the bridge of the nose.

[0545] Occipital bone: The occipital bone is the rear and lower part of the skull. It contains the foramen magnum, an oval hole through which the intracranial cavity connects with the vertebral canal. The curved plate posterior to the foramen magnum is the squama occipitalis.

[0546] Orbit: the bony cavity in the skull that houses the eyeball.

[0547] Parietal bones: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0548] Temporal bone: The temporal bone is located on the base and sides of the skull and supports parts of the face known as the temples.

[0549] Cheekbones: The two cheekbones in the face are located in the upper and outer parts of the face and form the cheek ridges. 5.10.4.3 Respiratory System Anatomy

[0550] Diaphragm: A sheet of muscle that runs over the lower rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, it increases the volume of the thoracic cavity and draws air into the lungs.

[0551] Larynx: The larynx or voice box that houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0552] Lung: respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0553] Nasal Cavity: The nasal cavity (or nasal fossa) is a large, air-filled space in the center of the face above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. The sides of the nasal cavity contain three horizontal extensions called turbinates or nasal conchae. The nasal cavity opens anteriorly into the nose and posteriorly into the nasopharynx via the choanae.

[0554] Pharynx: The part of the throat located immediately below (inferior to) the nasal cavity and above the esophagus and larynx. The pharynx is traditionally divided into three sections: the nasopharynx (upper pharynx) (nasal part of the pharynx), the oropharynx (mid pharynx) (oral part of the pharynx), and the hypopharynx (low pharynx). 5.10.5 Patient Interface

[0555] Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that vents to atmosphere in a fail-safe manner to reduce the risk of excessive CO2 rebreathing by the patient.

[0556] Elbow: An elbow is an example of a structure that directs the axis of airflow moving therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a generally circular cross section. In another form, the elbow may have an oval or rectangular cross section. In certain forms, the elbow may be rotatable relative to the mating component, for example, approximately 360 degrees. In certain forms, the elbow may be detachable from the mating component, for example, via a snap connection. In certain forms, the elbow may be assembled to the mating component via a one-time snap during manufacturing, but cannot be removed by the patient.

[0557] Frame: Frame is taken to mean the mask structure that supports the tension load between two or more points that connect the headgear. A mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of mask frames may be airtight.

[0558] Headgear: Headgear is taken to mean a form of positioning and stabilizing structure designed for use on the head. For example, the headgear may include a collection of one or more posts, ties, and stiffeners configured to position and hold a patient interface in place on a patient's face for delivery of respiratory therapy. Some ties are formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).

[0559] Membrane: Membrane is taken to mean a typically thin-walled element, preferably offering substantially no resistance to bending and resistance to extension.

[0560] Plenum Chamber: Mask plenum chamber is taken to mean a part of a patient interface having walls that at least partially enclose a volume of space, the air in the volume being pressurized to above atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.

[0561] Seal: When used as a noun ("seal"), it can refer to a structure, and when used as a verb ("to seal"), it can refer to an effect. Two elements can be constructed and / or arranged to "seal" or achieve a "sealing" effect between them without the need for a separate "sealing" element itself.

[0562] Shell: A shell is taken to mean a curved, relatively thin structure that has bending, tensile, and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0563] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0564] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0565] Swivel (noun): A subassembly of components configured to rotate, preferably independently, about a common axis, 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 less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a mating cylindrical conduit. In use, there is little leakage of air flow from the swivel.

[0566] Tie (noun): A structure designed to resist tension.

[0567] Vent: (noun): A structure that allows airflow to the ambient atmosphere inside a mask or conduit, allowing for a clinically effective push of exhaled gases. For example, for clinically effective push, flow rates of about 10 liters / minute to about 100 liters / minute may be used depending on mask design and treatment pressure. 5.10.6 Structural Shape

[0568] Products of the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or impeller). The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be distinguished using labels to describe the orientation, location, function, or some other characteristic of the associated surfaces. For example, the structure may include one or more of a front surface, a back surface, an interior surface, and an exterior surface. In another example, the seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or interior) surface. In another example, the structure may include a first surface and a second surface.

[0569] To facilitate the description of the shape and surface of a three-dimensional structure, we first consider a cross section at a point p through the surface of the structure. See Figures 3B-3F. Figures 3B-3F show an example cross section at point p on the surface and an example of the resulting planar curve. Figures 3B-3F also show the outward normal vector at p. The outward normal vector at p points away from the surface. In some examples, the surface is described from the perspective of a fictitious little person standing upright on the surface. 5.10.6.1 Curvature in one dimension

[0570] The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, 1 / radius of the circle tangent to the curve at p).

[0571] Positive curvature: If the curve at p bends toward the outward normal, the curvature at that point is taken to have a positive value (if our fictitious little person were to walk away from point p, they would have to walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such curves are often called concave.

[0572] Zero curvature: If the curve at p is a straight line, the curvature is taken as zero (if this imaginary little person walks away from point p, they can walk on a horizontal plane that is neither pointing up nor pointing down). See Figure 3D.

[0573] Negative curvature: If the curve at p bends away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if this imaginary little person were to walk away from point p, they would have to walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F) and Figure 3F (relatively large negative curvature compared to Figure 3E). Such curves are often called convex. 5.10.6.2 Two-dimensional surface curvature

[0574] A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple perpendicular cross sections. The multiple cross sections may cut the surface in a plane containing the outward normal (the "normal plane"), and each cross section may be taken in a different direction. Each cross section results in a plane curve with a corresponding curvature. The different curvatures at the point may have the same or different signs. Each curvature at the point has a (e.g., relatively small) magnitude. The plane curves in Figures 3B-3F may be examples of such multiple cross sections at a particular point.

[0575] Principal curvatures and directions: The directions of the normal planes along which the curvature of a curve reaches its maximum and minimum values ​​are called principal directions. In the example of Figures 3B-3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F, so Figures 3B and 3F are cross sections in the principal directions. The principal curvature at p is the curvature in the principal direction.

[0576] Surface region: A set of connected points on a surface. This set of points within a region may have similar properties (e.g., curvature or sign).

[0577] Saddle region: A region where the principal curvatures at each point have opposite signs (i.e., one positive sign and the other negative sign) (depending on the direction a hypothetical person who could be walking uphill or downhill is facing).

[0578] Dome area: An area where the principal curvatures at each point have the same sign: either both positive ("concave dome") or both negative ("convex dome")

[0579] Cylindrical region: A region in which one principal curvature is zero (or zero, for example, in a manufacturing tolerance) and the other principal curvature is non-zero.

[0580] Planar region: A region of a surface where both principal curvatures are zero (or are zero within a manufacturing tolerance, for example).

[0581] Surface Edge: The boundary or limit of a surface or area.

[0582] Path: In certain forms of the present technology, a "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of the present technology, a "path" may be described as a route or course that includes, for example, a set of points on a surface. (A hypothetical person's path is a place they walk on a surface, similar to a path in a garden.)

[0583] Path Length: In certain forms of the present technology, "path length" is taken to refer to 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 a fictional person is the distance walked along the path on the surface.)

[0584] Straight-line distance: Straight-line distance is the distance between two points on a surface, but does not take the surface into account. On a planar area, there is a path on the surface that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there cannot be a path that has the same path length as the straight-line distance between two points. (For a fictional person, straight-line distance corresponds to the distance "as the crow flies.") 5.10.6.3 Space curve

[0585] Space Curve: Unlike a plane curve, a space curve does not necessarily exist within any particular plane. A space curve may be closed, i.e., it has no endpoint. A space curve may be considered a one-dimensional piece of three-dimensional space. A fictional character walking on a strand of DNA helix walks along a space curve. A typical human left ear contains a left-handed helix (see Figure 3Q). A typical human right ear contains a right-handed helix (see Figure 3R). Figure 3S shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or impeller) may trace a space curve. In general, a space curve can be described by the curvature and twist at each point on the space curve. Torsion is a measure of the way the curve emanates from the plane. Twist has a sign and a magnitude. The twist at a point on a space curve can be characterized with respect to the tangent, normal, and binormal vectors at that point.

[0586] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional character were flying along a curve and fell off their vehicle at a particular point, the direction of the tangent vector would be the direction they would be traveling.

[0587] Unit normal vector: As the fictional character moves along the curve, this tangent vector itself changes. The unit vector that points in the same direction as the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0588] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P) or the left-hand rule (Figure 3O).

[0589] Oscillating plane: A plane containing a unit tangent vector and a unit principal normal vector. See Figures 3O and 3P.

[0590] Torsion of a Space Curve: The torsion at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures the degree of deviation of the curve from the tangential plane. A space curve that lies within a plane has zero torsion. If the space curve deviates from the tangential plane by a relatively small amount, the magnitude of torsion of the space curve is relatively small (e.g., a gently sloping spiral path). If the space curve deviates from the tangential plane by a relatively large amount, the magnitude of torsion of the space curve is relatively large (e.g., a steeply sloping spiral path). Referring to Figure 3S, because T2 > T1, the magnitude of torsion near the top coil of the spiral in Figure 3S is greater than the magnitude of torsion of the bottom coil of the spiral in Figure 3S.

[0591] Referring to the right-hand rule in Figure 3P, a space curve that bends toward the right-hand binormal can be considered to have a positive right-hand twist (e.g., a right-hand spiral as shown in Figure 3S). A space curve that bends away from the right-hand binormal can be considered to have a negative right-hand twist (e.g., a left-hand spiral).

[0592] Similarly, with reference to the left-hand rule (see Figure 3O), a space curve oriented in a left-handed binormal direction can be considered as having a positive left-handed twist (e.g., a left-handed spiral). Thus, a positive left-handed direction corresponds to a negative right-handed direction. See Figure 3T. 5.10.6.4 Holes

[0593] A surface may have one-dimensional holes (e.g., holes bounded by a planar or space curve). In the case of a thin structure (e.g., a membrane) that contains holes, the structure may be described as having one-dimensional holes. See, for example, how the one-dimensional holes in the surface of the structure shown in Figure 3I are bounded by a planar curve.

[0594] A structure can have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the tire's inner surface. In another example, a bladder with a cavity for air or gel can have a two-dimensional hole. See, for example, the cushion in FIG. 3L and the exemplary cross-sections in FIGS. 3M and 3N, where the inner surface bounding the two-dimensional hole is shown. In yet another example, a conduit can include a one-dimensional hole (e.g., at its inlet or its outlet) and can include a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole through the structure shown in FIG. 3K and bounded by a surface as shown. 5.11 Other Notes

[0595] A portion of the disclosure of this patent document contains material that is entitled to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of this patent document or this patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but reserves all copyright rights therefor for all other purposes.

[0596] Unless otherwise clearly indicated from the context and unless a range of values ​​is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limits of the range, and for any other stated or intervening value in the stated range, is encompassed by the technology. The upper and lower limits of these intervening ranges, independently included in the intervening range, are also encompassed by the technology if they specifically exceed the limits in the stated range. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed by the technology.

[0597] Furthermore, when values ​​are embodied herein as part of the present technology, unless otherwise specified, it is understood that such values ​​may be approximated and may be used to any appropriate significant figures to the extent practical technical practice permits or requires.

[0598] 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 be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0599] Although particular materials are described as being suitable for use in the construction of components, obvious alternative materials having similar properties may be substituted. Furthermore, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.

[0600] It should be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0601] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of these publications. The publications mentioned herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology does not antedate such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.

[0602] The terms "comprises" and "comprising" should be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that a described element, component, or step may be present in, utilized with, or combined with other elements, components, or steps not specifically described.

[0603] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the claim limitations.

[0604] Although the technology herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details unnecessary for the practice of the technology. For example, although the terms "first" and "second" (etc.) are used, unless otherwise specified, these terms are not intended to indicate any order but are used to distinguish between separate elements. Furthermore, although the process steps in the method may be described or illustrated in an ordered manner, such an order is not required. Those skilled in the art will recognize that such an order can be changed and / or aspects thereof can be performed simultaneously or even synchronously.

[0605] It is therefore to be understood that numerous modifications may be made in the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0606] 6000 Patient Interface 6300 Positioning and stabilizing structures (headgear) 6310 Upper fiber part 6320 First lower fiber part

Claims

1. 1. 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 branch section having a first portion and a second portion; an upper fabric portion formed from the rear section and the first portion, the upper fabric portion including a resilient circumferential band for fitting to a patient's head in use; at least one lower fabric portion formed from the second portion and movably connected to the upper fabric portion; at least a first lower fabric portion of the at least one lower fabric portion is stretchable relative to the upper fabric portion and constructed and arranged to provide a force to hold a seal-forming structure of the patient interface in a therapeutically effective position on the patient's head; a positioning and stabilizing structure, the first lower fiber portion being movable between a first position and a second position, the positioning and stabilizing structure being configured to rest on the patient's frontal bone at the first position proximal to the first portion and to rest on the patient's cheek at the second position distal to the first portion.

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

3. 3. The positioning and stabilising structure of claim 1 or claim 2, wherein the positioning and stabilising structure is in the form of a headband.

4. 4. The positioning and stabilising structure of claim 1, wherein the rear section of the headband includes a second branch section including a second portion of the upper fabric portion and further including a second lower fabric portion.

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

6. 6. The positioning and stabilising structure of claim 4 or claim 5, wherein the anterior section and the posterior section combine to form an X-shape in the second position.

7. 7. The positioning and stabilising structure of any one of claims 1 to 6, wherein the first lower fabric portion is a seal retaining band that is resiliently stretchable along at least a portion of its length and adapted to engage an outer surface of the patient interface to hold the seal-forming structure in the therapeutically effective position.

8. The positioning and stabilizing structure of claim 7 , wherein the seal retaining band is more elastic than the upper fabric portion.

9. The positioning and stabilising structure of claim 7 or claim 8, wherein the seal retaining band is adapted to be received within a channel of the patient interface.

10. The positioning and stabilizing structure of claim 9 , wherein the channel is formed in a plenum chamber of the patient interface.

11. A positioning and stabilising structure according to any one of claims 7 to 10, wherein the seal retaining band includes a port for coupling the seal-forming structure to an air circuit for supplying pressurised air to the patient.

12. 3. The positioning and stabilising structure of claim 1 or claim 2, comprising a pair of lower fabric portions adapted to couple to each other and / or to an intermediate structure to provide said force.

13. The positioning and stabilising structure of claim 12 , wherein the intermediate structure is a harness that holds the seal-forming structure in the therapeutically effective position in use.

14. The positioning and stabilizing structure of claim 12 , wherein the intermediate structure comprises the seal-forming structure or a portion thereof.

15. The positioning and stabilising structure according to any one of the preceding claims, wherein at least one said lower textile portion comprises one or more stiff sections.

16. 16. The positioning and stabilizing structure of claim 15, wherein said at least one lower fabric portion is stiffer in its mid-section than at its ends.

17. A positioning and stabilising structure according to any one of the preceding claims, comprising at least one sensor provided in or on the upper fabric part and / or one or more lower fabric parts.

18. 18. The positioning and stabilizing structure of claim 17, comprising at least one actuator provided in or on the upper fabric portion and / or one or more lower fabric portions.

19. 20. The positioning and stabilizing structure of claim 18, wherein the at least one sensor and / or the at least one actuator are partially exposed to the environment on an outer surface of the upper fabric portion or the one or more lower fabric portions and / or are partially exposed on a patient-contacting surface of the upper fabric portion or the one or more lower fabric portions so as to contact the patient's skin in use.

20. 20. The positioning and stabilizing structure of claim 18 or claim 19, wherein the at least one sensor and / or the at least one actuator is at least partially embedded between an outer layer of the upper fabric portion or one or more lower fabric portions and a patient-contacting layer.

21. 21. The positioning and stabilising structure of any one of claims 18 to 20, wherein the at least one sensor and / or the at least one actuator comprises a circuit formed at least in part by one or more conductive threads and / or one or more conductive ink traces.

22. A positioning and stabilising structure according to any one of claims 18 to 21, comprising at least one sensor holding structure for mounting each of said at least one sensor and / or said at least one actuator.

23. The positioning and stabilizing structure of claim 22 , wherein the at least one sensor holding structure includes at least one pocket that houses the at least one sensor and / or the at least one actuator.

24. 24. The positioning and stabilising structure of any one of claims 18 to 23, comprising a wireless communication interface for transmitting data from said at least one sensor to one or more external computing devices and / or for receiving data from said one or more external computing devices at said at least one actuator.

25. The positioning and stabilizing structure of any one of claims 18 to 24, 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. 1. A patient interface comprising: At least 6 cmH above ambient pressure ２ a plenum chamber pressurizable to an elevated therapeutic pressure and including a plenum chamber inlet port sized and configured to receive a flow of air at said therapeutic pressure for breathing by the patient; 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 airways, the seal-forming structure having holes therein so that the flow of air at the therapeutic pressure is delivered to at least the entrances to the patient's nares, the seal-forming structure being constructed and arranged to, in use, maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head; the positioning and stabilizing structure comprising: a front section and a rear section forming a continuous loop of material, the front section forming a first branch section having a first portion and a second portion; an upper fabric portion including a resilient circumferential band for fitting to the patient's head in use, the upper fabric portion being formed from the rear section and the first portion; at least one lower fabric portion formed from the second portion and movably connected to the upper fabric portion; at least a first lower fabric portion of the at least one lower fabric portion is stretchable relative to the upper fabric portion and constructed and arranged to provide a force to hold a seal-forming structure of the patient interface in a therapeutically effective position on the patient's head; a patient interface, the first lower fiber portion being movable between a first position and a second position, the first lower fiber portion being configured to rest on the patient's frontal bone at the first position proximal to the first portion and configured to rest on the patient's cheek at the second position distal to the first portion.

27. 27. A patient interface according to claim 26, wherein the first lower fabric portion is unitary with the upper fabric portion.

28. 28. A patient interface according to claim 26 or claim 27, wherein the positioning and stabilising structure is in the form of a headband.

29. 29. A patient interface according to any one of claims 26 to 28, wherein the rear section of the headband includes a second branch section including a second portion of the upper fabric portion and further including a second lower fabric portion.

30. 30. The positioning and stabilizing structure of claim 29, wherein the second portion of the upper fiber portion and the second lower fiber portion are configured to rest on the patient's occipital bone at the first position, and the second portion of the upper fiber portion is movable away from the second lower fiber portion to rest on the patient's parietal bone at the second position.

31. 31. The positioning and stabilising structure of claim 29 or claim 30, wherein the anterior section and the posterior section combine to form an X-shape in the second position.

32. 32. A patient interface according to any one of claims 26 to 31, wherein the first lower fabric portion is a seal retaining band that is resiliently stretchable along at least a portion of its length and adapted to engage an outer surface of the plenum chamber or the seal-forming structure to retain the seal-forming structure in the therapeutically effective position.

33. 33. A patient interface according to claim 32, wherein the seal retaining band is more elastic than the upper fabric portion.

34. 34. A patient interface according to claim 32 or claim 33, wherein the seal retaining band is received within a channel of the patient interface.

35. 35. A patient interface according to claim 34, wherein the channel is formed in an outer surface of the plenum chamber.

36. A patient interface according to any one of claims 32 to 35, wherein the seal retaining band includes a port for coupling the plenum chamber inlet port to an air circuit for supplying pressurised air to the patient.

37. 28. A patient interface according to claim 26 or claim 27, wherein the positioning and stabilising structure comprises a pair of lower textile sections adapted to couple to each other and / or to an intermediate structure to provide the force.

38. 38. A patient interface according to claim 37, wherein the intermediate structure is a harness that, in use, engages an outer surface of the plenum chamber or an outer surface of the seal-forming structure.

39. 38. A patient interface according to claim 37, wherein the intermediate structure includes the plenum chamber and / or the seal-forming structure, or portions thereof.

40. A patient interface according to any one of claims 26 to 39, wherein at least one pair of lower fabric portions comprises one or more stiff sections.

41. 41. A patient interface according to claim 40, wherein the at least one of the pair of lower fabric portions is stiffer at its mid section than at its ends.

42. 42. A patient interface according to any one of claims 26 to 41, comprising at least one sensor provided in or on the upper fabric portion, and / or at least one pair of lower fabric portions, and / or the plenum chamber, and / or the seal-forming structure.

43. 43. A patient interface according to claim 42, comprising at least one actuator provided in or on the upper fabric portion, and / or the at least pair of lower fabric portions, and / or the plenum chamber, and / or the seal-forming structure.

44. 44. A patient interface according to claim 43, wherein at least one sensor and / or at least one actuator is partially exposed to the environment on an outer surface of the upper fabric portion or the at least pair of lower fabric portions and / or partially exposed on a patient contacting surface of the upper fabric portion or the at least pair of lower fabric portions so as to contact the patient's skin in use.

45. 45. A patient interface according to claim 43 or claim 44, wherein 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 at least pair of lower fabric portions and a patient contacting layer.

46. 46. ​​A patient interface according to any one of claims 43 to 45, wherein at least one sensor and / or the at least one actuator comprises a circuit formed at least in part by one or more conductive threads and / or one or more conductive ink traces.

47. A patient interface according to any one of claims 43 to 46, comprising at least one sensor retaining structure for mounting each of the sensors and / or actuators.

48. 48. A patient interface according to claim 47, wherein the at least one sensor retention structure includes one or more pockets that accommodate the at least one sensor and / or the at least one actuator.

49. 49. A patient interface according to any one of claims 43 to 48, comprising a wireless communication interface for transmitting data from the at least one sensor to at least one external computing device and / or receiving data from the at least one external computing device at the at least one actuator.

50. The at least one sensor and / or the at least one actuator may be 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 CO ２ 50. A patient interface according to any one of claims 43 to 49, comprising one or more of a sensor, a vibration device, and an audio output device.

51. 51. A patient interface according to claim 50, wherein the at least one sensor includes at least one pressure sensor in fluid communication with a plenum chamber.

52. 52. A patient interface according to any one of claims 26 to 51, wherein the plenum chamber comprises a shell, having an inner shell surface and an outer shell surface, the inner shell surface being arranged to be at the therapeutic pressure in use and the outer shell surface being arranged to be at atmospheric pressure in use.

53. 53. A patient interface according to claim 52, wherein at least one pair of lower fabric portions engages at least a portion of the shell outer surface to retain the seal-forming structure in the therapeutically effective position.

54. 54. A patient interface according to claim 53 when associated with claim 34, wherein the channel is formed in the shell outer surface.

55. A patient interface according to any one of claims 52 to 54, wherein the shell is constructed from a hard plastic material.

56. A patient interface according to any one of claims 52 to 54, wherein the shell is semi-rigid and / or resilient.

57. A patient interface according to any one of claims 52 to 56, wherein the shell is constructed from a transparent material.

58. A patient interface according to any one of claims 52 to 57, wherein the shell is coupled to the seal-forming structure.

59. 1. A positioning and stabilizing structure for a patient interface, comprising: a headband formed at least in part from a textile material, having an upper textile portion movably connected to a first lower textile portion, and including at least one sensor disposed in or on the upper textile portion and / or the first lower textile portion; a positioning and stabilizing structure, the headband wearable on a patient's head in a first configuration in which the first lower fabric portion is adjacent to the upper fabric portion and configured to rest on the patient's forehead, and a second configuration in which the first lower fabric portion is separated from the upper fabric portion and provides a force to hold the seal-forming structure of the patient interface in a therapeutically effective position on the patient's head and configured to rest on the patient's cheek.

60. 60. The positioning and stabilizing structure of claim 59, comprising at least one actuator disposed in or on said upper fabric portion and / or said first lower fabric portion.

61. 61. The positioning and stabilizing structure of claim 60, wherein at least one sensor and / or at least one actuator is partially exposed to the surroundings on an outer surface of the upper fabric portion or the first lower fabric portion and / or partially exposed on a patient-contacting surface of the upper fabric portion or the first lower fabric portion so as to contact the patient's skin in use.

62. 62. The positioning and stabilizing structure of claim 60 or claim 61, wherein 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-contacting layer.

63. 63. The positioning and stabilising structure of any one of claims 60 to 62, wherein at least one sensor and / or at least one actuator comprises a circuit formed at least in part by one or more conductive threads and / or one or more conductive ink traces.

64. A positioning and stabilising structure according to any one of claims 60 to 63, comprising at least one sensor retaining structure for attachment to said at least one sensor and / or said at least one actuator.

65. 65. The positioning and stabilising structure of claim 64, wherein the one or more sensor holding structures include one or more pockets that house one or more respective sensors or actuators.

66. 66. The positioning and stabilising structure of any one of claims 60 to 65, comprising a wireless communication interface for transmitting data from said at least one sensor to at least one external computing device and / or for receiving data from said at least one external computing device at said at least one actuator.

67. 67. The positioning and stabilizing structure of any one of claims 60 to 66, 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.

68. 68. The positioning and stabilising structure of any one of claims 60 to 67, wherein the first lower fabric portion is integral with the upper fabric portion.

69. 69. The positioning and stabilizing structure of any one of claims 60 to 68, wherein the headband includes a first portion of the upper fabric portion, further includes the first lower fabric portion, and includes a first branch section located at a front of the headband.

70. 70. The positioning and stabilizing structure of claim 69, wherein the headband includes a second portion of the upper fabric portion, further includes a second lower fabric portion, and includes a second branch section located at a rear of the headband.

71. 71. The positioning and stabilising structure of any one of claims 59 to 70, wherein the first lower fabric portion is a seal retaining band that is resiliently stretchable along at least a portion of its length and adapted to engage an outer surface of the patient interface to retain the seal-forming structure in the therapeutically effective position.

72. 72. The positioning and stabilizing structure of claim 71, wherein said seal retaining band is more elastic than said upper fabric portion.

73. 73. The positioning and stabilising structure of claim 71 or claim 72, wherein the seal retaining band is adapted to be received within a channel of the patient interface.

74. 74. The positioning and stabilising structure of claim 73, wherein the channel is formed in a plenum chamber of the patient interface.

75. 75. The positioning and stabilising structure of any one of claims 71 to 74, wherein the seal retaining band includes a port for coupling the seal-forming structure to an air circuit for supplying pressurised air to the patient.

76. 76. The positioning and stabilising structure of any one of claims 59 to 75, wherein the first lower fabric portion comprises one or more stiff sections.

77. 77. The positioning and stabilizing structure of claim 76, wherein the first lower fabric portion is stiffer at its midsection than at its ends.

78. 78. The positioning and stabilizing structure of any one of claims 59 to 77, wherein at least one resilient hook is located on the first lower fabric portion and configured to connect to one or more protrusions or recesses in the plenum chamber and / or seal-forming structure.

79. 1. A patient interface comprising: At least 6 cmH above ambient pressure ２ a plenum chamber pressurizable to an elevated therapeutic pressure and including a plenum chamber inlet port sized and configured to receive a flow of air at said therapeutic pressure for breathing by the patient; 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 airways, the seal-forming structure having holes therein so that a flow of air at said therapeutic pressure is delivered to at least the entrances to the patient's nares, the seal-forming structure being constructed and arranged to, in use, maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle; A positioning and stabilising structure according to any one of claims 58 to 78; a patient interface including:

80. 80. A patient interface according to claim 79, further comprising one or more sensors positioned in or on an interior surface of the plenum chamber.

81. The one or more sensors may include a pressure sensor, a humidity sensor, a temperature sensor, and a CO ２ 81. A patient interface according to claim 80 comprising one or more of the sensors.

82. 82. A system for diagnosing and / or monitoring a respiratory disorder, the system comprising: a patient interface according to any one of claims 42-58 or 79-81; and at least one computing device in communication with the patient interface to receive data from one or more sensors of the patient interface.

83. 1. A system for treating a respiratory disorder in a patient, comprising: A patient interface according to any one of claims 42 to 58 or 79 to 81; a pressure generator configured to generate an airflow to the patient interface to treat the respiratory disorder; a controller configured to control the pressure generator to adjust the airflow based on at least one signal received from the at least one sensor of the patient interface; A system including:

84. 84. The system of claim 83, wherein the at least one sensor of the patient interface includes an EMG and / or EOG sensor, and wherein the controller is configured to analyze the at least one signal to detect a sleep stage of the patient, control the pressure generator to adjust the airflow based on the sleep stage, and / or activate one or more audio devices to generate sleep-enhancing noises.

85. 85. The system of claim 83 or claim 84, wherein the at least one sensor of the patient interface includes a microphone, and the controller is configured to analyze a signal from the microphone to detect snoring and to control the pressure generator to adjust the airflow based on the detected signal.

86. 86. The system of any one of claims 83 to 85, wherein the at least one sensor includes a humidity sensor and a temperature sensor in the plenum chamber, and the controller is configured to control the pressure generator to adjust the air flow according to signals from the humidity sensor and the temperature sensor to reduce or prevent condensation buildup.

87. 87. The system of claim 86, further comprising a humidifier, wherein the controller is configured to control the humidifier according to signals from the humidity sensor and temperature sensor to reduce or prevent condensation buildup.

88. The at least one sensor detects CO in a plenum chamber. ２ a CO sensor, and the controller ２ CO measured by the sensor ２ detecting whether the level exceeds a threshold, and controlling the patient interface and / or the pressure generator to determine whether the CO 2 concentration exceeds a threshold based on the detected signal. ２ 89. A system according to any one of claims 83 to 88, configured to reduce the level.

89. 90. The system of claim 88, wherein the controller is configured to send a signal to the patient interface to open an electromechanical vent in communication with the plenum chamber, thereby allowing for greater flushing of air from the plenum chamber.

90. The controller controls the pressure generator to increase the flow rate to reduce CO ２ 90. The system of claim 88 or claim 89, configured to flush away

91. 91. A system according to any one of claims 83 to 90 when appended to claim 44, wherein one or more actuators of the patient interface include a tactile feedback element.

92. 92. The system of claim 91, wherein the tactile feedback element is located in an area of ​​a positioning and stabilizing structure that overlies the temple region of the patient's head in use.

93. 93. The system of claim 91 or claim 92, wherein the at least one sensor includes a pulse oximeter, and the controller is configured to receive a heart rate measurement from the pulse oximeter and, in response to detecting that the heart rate measurement exceeds a threshold, control the tactile feedback element to deliver vibrations to the patient at a rate slower than the heart rate measurement.

94. 94. The system of claim 91, wherein the controller is configured to analyze the at least one signal to detect a sleep position and / or whether a number of apnea and / or hypopnea events of the patient exceeds a threshold, and based on the detection, to send a control signal to the tactile feedback element to deliver a tactile stimulus to the patient.

95. 95. The system of any one of claims 83 to 94, wherein the at least one sensor includes an accelerometer, and the controller is configured to analyze signals from the accelerometer to detect a position of the patient, and to control the pressure generator to adjust the airflow based on the detection of the position.

96. slowly increasing pressure if the detected signal indicates that the patient is lying supine; reducing pressure if the detected signal indicates that the patient is lying on their side; 96. The system of claim 95, wherein the flow and pressure are reduced below therapeutic pressure if the detected signal indicates that the patient is in an upright position.

97. 97. The system of any one of claims 83 to 96, wherein the at least one sensor includes a gyroscope, and the controller is configured to analyze signals from the gyroscope to detect movement of the patient, and to control the pressure generator to adjust the airflow based on the detection of the movement.

98. If the motion detected signal indicates a high degree of motion, the controller is configured to control the pressure generator to adjust the pressure below a therapeutic pressure; 98. The system of claim 97, wherein when the movement detected signal indicates a low degree of movement, the controller is configured to control the pressure generator to gradually adjust pressure toward the therapeutic pressure.

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