Patient interface and positioning and stabilizing structure for patient interface

Abstract

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

Description

[0001] This application is a divisional application of patent application No. 202180052398.1, filed on June 29, 2021, entitled "Patient Interface and Positioning and Stabilization Structure for Patient Interface". Patent application No. 202180052398.1 is the Chinese national phase application of PCT application No. PCT / SG2021 / 050378.

[0002] 1. Cross-references to related applications This application claims the benefit of U.S. Patent Application No. 10202006315Y, filed June 30, 2020, the entire contents of which are incorporated herein by reference. Background Technology 2.1 Technical Field This technology relates to one or more of the following: screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses.

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

[0004] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from inhaled air and carbon dioxide to be expelled in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, published in 2012 by John B. West, Lippincott Williams & Wilkins.

[0005] A range of respiratory disorders exist. Some disorders may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

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

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. The condition causes affected individuals to stop breathing, typically for periods ranging from 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can contribute to cardiovascular disease and brain damage. Concomitant symptoms are common, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Due to the repetitive hypoxia, CSR can be harmful. In some patients, CSR is associated with repetitive awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0009] Respiratory failure is a broad term encompassing respiratory disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure may cover some or all of the following disorders.

[0010] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormally rapid breathing during exercise.

[0011] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These diseases include increased airflow resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0013] Neuromuscular disease (NMD) is a broad term encompassing many diseases and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens within months and leads to death within years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over many years and only slightly reduces life expectancy (e.g., limb girdle, scapular humerus, and myotonic dystrophy). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood changes.

[0014] The chest wall is a group of thoracic wall disorders that lead to inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0015] A range of treatments have been used to treat or alleviate these conditions. Furthermore, other healthy individuals may utilize these treatments to prevent respiratory distress. However, these treatments have many drawbacks.

[0016] 2.2.2 Treatment Various respiratory therapies, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), have been used to treat one or more of the aforementioned respiratory disorders.

[0017] 2.2.2.1 Respiratory pressure therapy Respiratory pressure therapy involves supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy such as canister ventilators or duct ventilators).

[0018] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary, so patients may choose not to adhere to treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0019] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-invasive respiratory disease (NMD), and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0020] Noninvasive ventilation (IV) provides ventilatory support for patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0021] 2.2.2.2 Flow Therapy Not all respiratory therapies are designed to deliver a prescribed therapeutic pressure. Some respiratory therapies are designed to deliver a prescribed respiratory volume by delivering an inspiratory flow rate profile (possibly superimposed on a positive baseline pressure) over a target duration. In others, the interface to the patient's airway is "open" (unsealed), and the respiratory therapy may supplement only the patient's own spontaneous breathing with a regulated or enriched flow of gas. In one example, high-flow therapy (HFT) delivers a continuous, heated, humidified flow of air to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that remains approximately constant throughout the respiratory cycle. This therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow rate of air at the airway inlet improves ventilation efficiency by flushing or washing out exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as deadspace therapy (DST). Other benefits may include increased warmth and humidity (which may be beneficial in secretion management) and the possibility of appropriately increasing airway pressure. As an alternative to constant flow, therapeutic flow can follow a curve that varies throughout the respiratory cycle.

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

[0023] 2.2.2.3 Supplementing oxygen For some patients, oxygen therapy can be combined with respiratory pressure therapy (RPT) or high-pressure airflow (HFT) by adding supplemental oxygen to the pressurized airflow. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting treatment is called HFT with supplemental oxygen.

[0024] 2.2.3 Respiratory Therapy System These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.

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

[0026] 2.2.3.1 Patient Interface Patient interfaces can be used to attach breathing equipment to their wearer, for example, by providing an airflow into the airway inlet. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal (e.g., a seal) with the area of ​​the patient's face to facilitate the delivery of gas at a pressure sufficiently varied with ambient pressure at a positive pressure of about 10 cmH2O relative to ambient pressure. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of about 10 cmH2O to the airway. For flow-based treatments such as nasal HFT, the patient interface is configured to blow through the nostrils, but a complete seal is specifically avoided. An example of such a patient interface is a nasal cannula.

[0027] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain suitable pressure. Mask systems for underwater swimming or diving may be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient.

[0028] Some masks may be clinically disadvantageous for this technology, such as those that block airflow through the nose and only allow it through the mouth.

[0029] If some masks require patients to insert a portion of the mask structure into their mouths to form and maintain a seal through their lips, they may be uncomfortable or not feasible for this technology.

[0030] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on a pillow.

[0031] The design of the patient interface presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head comprises bones, cartilage, and soft tissues, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during respiratory therapy sessions.

[0032] Due to these challenges, some face shields suffer from one or more of the following problems: obtrusive, unattractive, expensive, mismatched, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized face shield can lead to reduced adherence, decreased comfort, and poorer patient outcomes. Face shields designed solely for pilots, those designed as part of personal protective equipment (e.g., filtering face shields), SCUBA face shields, or those designed for administering anesthetics are acceptable for their original applications, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment, especially if the face shield is worn during sleep.

[0033] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing difficulties. Patients may not adhere to treatment if the mask is uncomfortable or difficult to use. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may be unable to clean it, which could affect adherence.

[0034] While masks designed for other applications (e.g., pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0035] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0036] 2.2.3.1.1 Sealing Formation Structure Patient interfaces may include sealing structures. Because they come into direct contact with the patient's face, the shape and configuration of the sealing structure can directly affect the effectiveness and comfort of the patient interface.

[0037] The patient interface is characterized in part by the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils during use. Such a single element may be designed, for example, to cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0038] A sealing structure that works effectively in one area of ​​a patient's face may not be suitable for another, for example, due to the different shapes, structures, variations, and sensitive areas of the patient's face. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0039] Certain seal-forming structures can be designed for mass production, allowing a design to be suitable, comfortable, and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0040] One type of seal-forming structure extends around the periphery of a patient interface and, when force is applied to the patient interface while the seal-forming structure engages face-to-face with the patient's face, serves to seal the patient's face. The seal-forming structure may include an air or fluid-filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0041] Another type of seal-forming structure incorporates a sheet-like seal of thin material surrounding the perimeter of the mask to provide a self-sealing effect on the patient's face when positive pressure is applied within the mask. Similar to the previous type of seal-forming section, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or deform during use, leading to leaks.

[0042] Another type of sealing structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0043] Another form of sealing can be achieved using adhesives. Some patients may find it inconvenient to constantly apply and remove adhesives from their face.

[0044] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0045] One form of nasal pillow is found in Adam Circuit, manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett.

[0046] ResMed Ltd. manufactures the following products that combine nose pillows: SWIFT TM Nose pillow mask, SWIFT TM II Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and MIRAGELIBERTY TM Full-face mask. The following patent application assigned to ResMed Ltd. describes an example of a nose pillow mask: International Patent Application WO2004 / 073,778 (which describes a ResMed Ltd. SWIFT mask). TM Other aspects of the nose pillow); U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc.'s SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO 2005 / 063328 and WO 2006 / 130,903 (which describe other aspects of ResMed's MIRAGE LIBERTY™ full-face mask); International patent application WO2009 / 052,560 (which describes ResMed's SWIFT TM Other aspects of the FX nose pillow).

[0047] 2.2.3.1.2 Positioning and Stabilization The sealing structure of the patient interface used in positive pressure therapy is subject to a force corresponding to the air pressure that would disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain it in a sealed relationship with the appropriate part of the face.

[0048] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0049] Another technique involves using one or more straps and / or stabilizing straps. Many of these straps suffer from one or more of the following problems: ill-fitting, bulky, uncomfortable, and inconvenient to use.

[0050] Another known difficulty in the positioning and stabilization of devices used for respiratory therapy is that they can be complex for patients, requiring attachment and proper positioning on the head for effective treatment. Additionally, for those new to respiratory therapy, wearing an unfamiliar device that may cover a large portion of the head can be an unfamiliar and challenging experience, potentially hindering patient compliance.

[0051] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned treatments, such as by operating the device to generate an airflow for delivery to an airway interface. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Therefore, RPT devices can also be used as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0052] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0053] One example of a specific requirement for certain RPT devices is noise.

[0054] Noise output level table for existing RPT devices (only one sample, measured in CPAP mode using the test method specified in ISO 3744 at 10 cmH2O).

[0055]

[0056] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed. Another example of an RPT device is a ventilator. Ventilators, such as the ResMedStellar™ series of adult and pediatric ventilators, can provide invasive and non-invasive non-dependent ventilatory support for a range of patients to treat a variety of conditions, including but not limited to NMD, OHS, and COPD.

[0057] The ResMed Elisée™ 150 and ResMed VS III™ ventilators provide support for invasive and non-invasive dependent ventilation in adult and pediatric patients for the treatment of a variety of conditions. These ventilators offer volume-based and pressure-based ventilation modes with single-limb or dual-limb circuits. RPT devices typically include a pressure generator, such as a motor-driven blower or a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, airflow can be supplied to the patient's airway under positive pressure. The RPT device outlet is connected via an air circuit to a patient interface such as those described above.

[0058] This provides designers with countless options. Design standards often conflict, meaning that some design choices are far from conventional or unavoidable. Furthermore, certain aspects of comfort and efficiency can be highly sensitive to small and subtle changes in one or more parameters.

[0059] 2.2.3.3 Air Circuit An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, an air circuit with separate branches may be used for inhalation and exhalation. In other cases, a single-branch air circuit is used for both inhalation and exhalation.

[0060] 2.2.3.4 Humidifier Delivering an unhumidified airflow can lead to airway dryness. Using a humidifier with an RPT device and patient interface produces humidified gas, minimizing dryness of the nasal mucosa and increasing patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air.

[0061] Many artificial humidification devices and systems are known, however, they do not meet the specific requirements of medical humidifiers.

[0062] When needed, typically in areas where patients may sleep or rest (e.g., in hospitals), medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to ambient air. Medical humidifiers for bedside placement can be very small. Medical humidifiers can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (e.g., saunas, air conditioners, evaporative coolers, etc.) can also humidify the air inhaled by the patient; however, these systems also humidify and / or heat the entire room, which may make the occupant uncomfortable. Furthermore, medical humidifiers may have stricter safety restrictions than industrial humidifiers.

[0063] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide insufficient humidification, and some may be difficult or inconvenient for patients to use.

[0064] 2.2.3.5 Oxygen Source Experts in this field have recognized the long-term benefits of exercise for patients with respiratory failure, slowing disease progression, improving quality of life, and extending lifespan. However, most stationary forms of exercise, such as treadmills and stationary bikes, are too strenuous for these patients. Therefore, the need for mobility has long been recognized. Until recently, this mobility was facilitated by using small compressed oxygen cylinders or tanks mounted on a handcart with wheels. The disadvantages of these cylinders are that they contain a limited amount of oxygen and are heavy, weighing approximately 50 pounds when mounted.

[0065] Oxygen concentrators have been used for approximately 50 years to provide oxygen for respiratory therapy. Traditional oxygen concentrators are bulky and cumbersome, making routine rescue operations 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 produce a theoretically unlimited supply of oxygen. To make these devices smaller and more mobile, the various systems used to produce oxygen-enriched gas need to be condensed. POCs aim to utilize the oxygen they produce as efficiently as possible while minimizing weight, size, and power consumption. This can be achieved by delivering oxygen in a series of pulses, or “boli,” each pulse timed to coincide with the start of inspiration. This treatment mode is called pulsed oxygen delivery (POD) or demand mode, in contrast to the traditional continuous flow delivery more suited to stationary oxygen concentrators.

[0066] 2.2.3.6 Data Management There are many clinical reasons to obtain data to determine whether a patient is “adhering” to a prescription treatment for respiratory therapy, such as if the patient has used their RPT device according to one or more “adherence rules.” One example of an adherence rule for CPAP therapy is to require the patient to use their RPT device for at least four hours each night for at least 21 or 30 consecutive days to be considered adherent. To determine patient adherence, RPT device providers, such as healthcare providers, can manually obtain data describing the patient’s treatment with the RPT device, calculate usage over the predetermined time period, and compare it to the adherence rules. Once the healthcare provider has determined that the patient has used their RPT device according to the adherence rules, the healthcare provider can inform the patient of the third part of adherence.

[0067] Patient treatment can benefit from other aspects of communication between treatment data and third-party or external systems. For example, performance data with functions such as indicating the impact of treatment on the patient and / or instructing the patient interface would be useful, enabling greater control over treatment.

[0068] Existing methods for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0069] 2.2.3.7 Vent technology Some forms of therapeutic systems may include a vent to allow the removal of exhaled carbon dioxide. The vent allows gas to flow from the internal space of the patient interface (e.g., a pneumatic chamber) to the external space of the patient interface, such as into the environment.

[0070] The vent may include an opening through which gas can flow during mask use. Many such vents are noisy. Others may become blocked during use, thus providing insufficient flushing. Some vents can, for example, disrupt the sleep of the patient's bed partner by causing noise or congested airflow.

[0071] ResMed has developed numerous improved mask vent technologies. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. US 2009 / 0044808.

[0072] The noise meter for the existing face mask (ISO 17510-2:2007, pressure of 10 cmH2O at 1 m)

[0073] (*Only one sample, measured in CPAP mode using the test method specified in ISO 3744 at 10 cmH2O) The sound pressure levels for various objects are listed below.

[0074] 2.2.4 Screening, Diagnosis and Monitoring System Polysomnography (PSG) is a routine system used for the diagnosis and monitoring of cardiopulmonary diseases and typically involves a clinical specialist in its application. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), and electromyography (EMG). PSG for sleep-disordered breathing has involved two nights of observation of the patient in the clinic: one night for pure diagnosis and a second night for the clinician to determine treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, due to the complex equipment required, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing, which is difficult or even impossible for the patient to properly attach for appropriate evaluation.

[0075] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically yields a true / false result, indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis provides clinically actionable information. Screening and diagnosis tend to be one-off processes, while monitoring disease progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0076] Clinicians may be able to adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where clinicians may not be available or may not be able to afford them. Different clinicians may have differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. Summary of the Invention This technology relates to providing medical devices for diagnosing, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0077] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0078] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0079] One aspect of this technology in certain forms is used to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0080] One form of this technology includes a patient interface, which includes: A pneumatic chamber capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the inlet port being sized and structured to receive airflow for patient respiration at the treatment pressure. A sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, the sealing structure having an opening therein such that an airflow under the therapeutic pressure is delivered at least to the inlet of the patient's nostrils, the sealing structure being configured and arranged to maintain the therapeutic pressure in the pneumatic chamber throughout the patient's respiratory cycle during use. The positioning and stabilizing structure is configured to provide forces that hold the sealing structure in a therapeutically effective position on the patient's head; One form of this technology includes a positioning and stabilizing structure for a patient interface, which can be switched between a first pre-treatment configuration and a second configuration. In the first pre-treatment configuration, the positioning and stabilizing structure can be worn by the patient as a headband. In the second configuration, the positioning and stabilizing structure can be used to apply force to hold the sealing structure in the proper position on the patient's face for effective respiratory therapy.

[0081] Another form of this technology includes a patient interface having one or more sensors embedded, attached, or otherwise arranged therein and / or on it for measuring patient data and / or device-related data for screening, monitoring, and / or diagnostic purposes.

[0082] One form of this technology includes a positioning and stabilizing structure for a patient interface, comprising: an upper fabric portion including an elastic circumferential band for engaging with 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 one first lower fabric portion is stretchable relative to the upper fabric portion and is configured and arranged to provide forces for holding the sealing structure of the patient interface in a therapeutically effective position on the patient's head.

[0083] One form of this technology includes a patient interface, which includes: A pneumatic chamber capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the inlet port being sized and structured to receive airflow for patient respiration at the treatment pressure. A sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, the sealing structure having an opening therein such that an airflow under therapeutic pressure is delivered at least to the inlet of the patient's nostrils, the sealing structure being configured and arranged to maintain therapeutic pressure in the pneumatic chamber throughout the patient's respiratory cycle during use. The positioning and stabilizing structure is configured to provide forces that hold the sealing structure in a therapeutically effective position on the patient's head; The positioning and stabilizing structures include: Includes the upper fabric portion of the elastic circumferential band used to fit onto the patient's head during use; and At least one lower fabric portion is movably connected to the upper fabric portion; At least one of the first lower fabric portions is stretchable relative to the upper fabric portion and is configured and arranged to provide force for holding the sealing structure of the patient interface in a therapeutically effective position on the patient's head.

[0084] One form of the technology includes a positioning and stabilizing structure for a patient interface, comprising: a front segment and a rear segment of a continuous ring of forming material, the front segment forming a first bifurcation segment having a first portion and a second portion; an upper fabric portion including an elastic circumferential band for adapting to a patient's head in use, the upper fabric portion being formed by the rear segment and the first portion; and at least one lower fabric portion of the at least one lower fabric portion movably connected to the upper fabric portion; wherein at least the first lower fabric portion is stretchable relative to the upper fabric portion and is configured and arranged to provide force to hold the sealing 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, the first lower fabric portion being configured in the first position to be close to the first portion and cover the patient's frontal bone, and the first lower fabric portion being configured in the second position to be away from the first portion and cover the patient's cheek.

[0085] One form of this technology includes a patient interface, which includes: A pneumatic chamber capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the inlet port being sized and structured to receive airflow for patient respiration at the treatment pressure. A sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, the sealing structure having an opening therein such that an airflow under therapeutic pressure is delivered at least to the inlet of the patient's nostrils, the sealing structure being configured and arranged to maintain therapeutic pressure in the pneumatic chamber throughout the patient's respiratory cycle during use. The positioning and stabilizing structure is configured to provide forces that hold the sealing structure in a therapeutically effective position on the patient's head; The positioning and stabilizing structures include: A front section and a rear section forming a continuous ring of material, wherein the front section forms a first bifurcation section having a first portion and a second portion; The upper fabric portion includes an elastic circumferential band for fitting onto a patient's head in use, the upper fabric portion being formed by the rear segment and the first portion; and At least one lower fabric portion is movably connected to the upper fabric portion; At least one first lower fabric portion of the at least one lower fabric portion is stretchable relative to the upper fabric portion and is configured and arranged to provide a force for holding the sealing structure of the patient interface in a therapeutically effective position on the patient's head; and The first lower fabric portion is movable between a first position and a second position. The first lower fabric portion is configured to be close to the first portion and cover the patient's frontal bone in the first position, and the first lower fabric portion is configured to be away from the first portion and cover the patient's cheek in the second position.

[0086] In the examples of the foregoing aspects: (a) the first lower fabric portion is integral with the upper fabric portion; (b) the positioning and stabilizing structure is in the form of a headband; (c) the headband includes a first bifurcated section, which includes a first portion of the upper fabric portion and also includes the first lower fabric portion, the first bifurcated section being located at the front of the headband; (d) the headband includes a second bifurcated section, which includes a second portion of the upper fabric portion and also includes a second lower fabric portion, the second bifurcated section being located at the rear of the headband; (e) the first The lower fabric portion is a sealing retainer strip that is elastically stretchable along at least a portion of its length and adapted to engage with the outer surface of the patient interface to retain the sealing structure in the therapeutically effective position; (f) the sealing retainer strip is more stretchable than the upper fabric portion; the sealing retainer strip is adapted to be received in a channel of the patient interface; (g) the channel is formed in a pneumatic chamber of the patient interface; and / or (h) the sealing retainer strip includes a port for connecting the sealing structure to an air circuit for supplying pressurized air to the patient.

[0087] In the examples of the foregoing aspects: (a) the positioning and stabilizing structure includes a pair of lower fabric portions adapted to be connected to each other and / or connected to an intermediate structure to provide the force; (b) the intermediate structure is a carrying strap that holds the sealing-forming structure in the therapeutically effective position during use; (c) the intermediate structure includes the sealing-forming structure or a portion thereof; and / or (d) the lower fabric portions are connected to each other or connected to the intermediate structure by one or more elastic hooks or straps.

[0088] In the examples of the foregoing aspects: (a) at least one lower fabric portion includes one or more rigid sections; and / or (b) at least one of the lower fabric portions has higher rigidity in its middle section than at its ends.

[0089] In examples of the foregoing aspects: (a) the positioning and stabilizing structure includes one or more sensors disposed in or above the upper fabric portion and / or one or more lower fabric portions; (b) the positioning and stabilizing structure includes one or more actuators disposed in or above the upper fabric portion and / or one or more lower fabric portions; (c) at least one sensor or at least one actuator is partially exposed to the environment on the outer surface of the upper fabric portion or the one or more lower fabric portions; or partially exposed at the patient contact surface of the upper fabric portion or the one or more lower fabric portions for contact with the patient's skin during use; (d) at least one sensor or at least one actuator is at least partially embedded between the outer layer of the upper fabric portion or the one or more lower fabric portions and the patient contact layer; (e) at least one sensor and / or at least one actuator includes at least partially formed by one or more conductive wires and / or one or more conductive... (f) The positioning and stabilizing structure includes one or more sensor holding structures for attaching a corresponding sensor and / or actuator among these sensors and / or actuators; (g) The one or more sensor holding structures include one or more pockets for receiving one or more corresponding 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 for receiving data from the one or more external computing devices at the one or more actuators; and / or (i) The one or more sensors and / or one or more actuators include one or more of the following: accelerometer; gyroscope; humidity sensor; temperature sensor; microphone; camera; pulse oximeter; EEG sensor; EMG sensor; EOG sensor; touch sensor; vibration device; and audio output device.

[0090] In the examples of the foregoing aspects: (a) the first lower fabric portion is integral with the upper fabric portion; (b) the positioning and stabilizing structure is in the form of a headband; (c) the headband includes a first bifurcated section, which includes a first portion of the upper fabric portion and also includes the first lower fabric portion, the first bifurcated section being located at the front of the headband; (d) the headband includes a second bifurcated section, which includes a second portion of the upper fabric portion and also includes a second lower fabric portion, the second bifurcated section being located at the rear of the headband; (e) the first lower fabric portion (a) a sealing retainer band, at least a portion of which is elastically stretchable along its length and adapted to engage with the outer surface of the pneumatic chamber or the sealing structure to retain the sealing structure in the therapeutically effective position; (f) the sealing retainer band is more stretchable than the upper fabric portion; (g) the sealing retainer band is received in a channel in the patient interface; (h) the channel is formed in the outer surface of the pneumatic chamber; and / or (i) the sealing retainer band includes a port for connecting the pneumatic chamber inlet to an air circuit for supplying pressurized air to the patient.

[0091] In the examples of the foregoing aspects: (a) the positioning and stabilizing structure includes a pair of lower fabric portions adapted to be coupled to each other or to an intermediate structure to provide the force; (b) the intermediate structure is a strap that engages with the outer surface of the pneumatic chamber or the outer surface of the sealing structure during use; (c) the intermediate structure includes the pneumatic chamber and / or the sealing structure, or a portion thereof; (d) the pneumatic chamber and / or the sealing structure includes one or more protrusions or recesses for coupling one or more protrusions or recesses; (e) the lower fabric portions are coupled to each other and / or to the intermediate structure by one or more elastic hooks or straps; (f) at least one lower fabric portion includes one or more rigid portions; and / or (g) at least one lower fabric portion has higher rigidity in its intermediate section than at its ends.

[0092] In the examples of the foregoing aspects: (a) the patient interface includes one or more sensors provided in or on the upper fabric portion, and / or the at least one lower fabric portion, and / or the pneumatic chamber, and / or the sealing structure; (b) the patient interface includes one or more actuators provided in or on the upper fabric portion, and / or the at least one lower fabric portion, and / or the pneumatic chamber, and / or the sealing structure; (c) at least one sensor and / or at least one actuator is partially exposed to the surrounding environment at the outer surface of the upper fabric portion or the at least one lower fabric portion; and / or partially exposed at the patient contact surface of the upper fabric portion or the at least one lower fabric portion for contact with the patient's skin during use; (d) at least one sensor or at least one actuator is at least partially embedded between the outer layer of the upper fabric portion or the at least one lower fabric portion and the patient contact layer; (e) at least one sensor and / or at least one actuator includes at least a portion (f) The patient interface includes one or more sensor holding structures for attaching corresponding sensors and / or actuators; (g) The one or more sensor holding structures include one or more pockets for receiving one or more corresponding sensors or actuators; (h) The patient interface includes a wireless communication interface for transmitting data from the one or more sensors to one or more external computing devices, and / or for receiving data from the one or more external computing devices at the one or more actuators; and / or (i) The one or more sensors and / or one or more actuators include one or more of the following: accelerometer; gyroscope; humidity sensor; temperature sensor; microphone; camera; pulse oximeter; EEG sensor; EMG sensor; EOG sensor; touch sensor; pressure sensor; CO2 sensor; vibration device; and audio output device.

[0093] In the examples of the foregoing aspects: (a) the pneumatic chamber includes a housing and has an inner surface and an outer surface, wherein the inner surface is arranged to be under the treatment pressure during use, and the outer surface is arranged to be under ambient pressure during use; (b) at least one lower fabric portion engages with at least a portion of the outer surface to retain the sealing structure in the effective treatment position; (c) the channel is formed in the outer surface; (d) the housing is made of a rigid plastic material; and / or (e) the housing is made of a transparent material.

[0094] One form of this technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure comprising: A headband, which is at least partially formed of a fabric material and has an upper fabric portion movably connected to a first lower fabric portion, the headband including one or more sensors provided in or above the upper fabric portion and / or the first lower fabric portion; The headband can be worn on the patient's head in a first configuration and a second configuration. In the first configuration, the first lower fabric portion is adjacent to the upper fabric portion. In the second configuration, the first lower fabric portion is separated from the upper fabric portion and provides force to hold the sealing structure of the patient interface in a therapeutically effective position on the patient's head.

[0095] In the examples of the foregoing aspects: (a) the positioning and stabilizing structure includes one or more actuators disposed in or above the upper fabric portion and / or the first lower fabric portion; (b) at least one sensor and / or at least one actuator is partially exposed to the surrounding environment at the outer surface of the upper fabric portion or the first lower fabric portion; and / or partially exposed at the patient contact surface of the upper fabric portion or the first lower fabric portion so as to contact the patient's skin in use; (c) at least one sensor and / or at least one actuator is at least partially embedded between the outer layer of the upper fabric portion or the first lower fabric portion and the patient contact layer; (d) at least one sensor and / or at least one actuator includes circuitry at least partially formed by one or more conductive wires and / or one or more conductive ink lines; (e) the positioning and stabilizing structure includes attachment... (f) One or more sensor holding structures for corresponding sensors and / or actuators in these sensors and / or actuators; (g) The one or more sensor holding structures include one or more pockets to accommodate one or more corresponding sensors or actuators; (h) The positioning and stabilization 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 from the one or more external computing devices at the one or more actuators; and / or (h) The one or more sensors and / or one or more actuators include one or more of the following: accelerometer; gyroscope; humidity sensor; temperature sensor; microphone; camera; pulse oximeter; EEG sensor; EMG sensor; EOG sensor; touch sensor; vibration device; and audio output device.

[0096] In the examples of the foregoing aspects: (a) the first lower fabric portion is integral with the upper fabric portion; (b) the headband includes a first bifurcation segment, which includes a first portion of the upper fabric portion and also includes the first lower fabric portion, the first bifurcation segment being located at the front of the headband; (c) the headband includes a second bifurcation segment, which includes a second portion of the upper fabric portion and also includes a second lower fabric portion, the second bifurcation segment being located at the rear of the headband; (d) the first lower fabric portion is a sealing retaining band, the sealing retaining band being elastically stretchable along at least a portion of its length, and (e) The sealing retainer is more stretchable than the upper fabric portion; (f) The sealing retainer is adapted to be received in a channel of the patient interface; (g) The channel is formed in a pneumatic chamber of the patient interface; (h) The sealing retainer includes a port for connecting the sealing structure to an air circuit for supplying pressurized air to the patient; and / or (i) The first lower fabric portion includes one or more rigid portions; and / or (j) The first lower fabric portion has greater rigidity in its middle section than at its ends.

[0097] One form of this technology includes a patient interface, which includes: A pneumatic chamber capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the inlet port being sized and structured to receive airflow for patient respiration at the treatment pressure. A sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, the sealing structure having an opening therein such that an airflow under the therapeutic pressure is delivered at least to the inlet of the patient's nostrils, the sealing structure being configured and arranged to maintain the therapeutic pressure in the pneumatic chamber throughout the patient's respiratory cycle during use. Positioning and stabilizing structures according to any of the foregoing aspects or embodiments.

[0098] In the example of the foregoing aspect: (a) the patient interface further includes one or more sensors located in or above the inner surface of the pneumatic chamber; and / or (b) the one or more sensors include one or more of the following: a pressure sensor; a humidity sensor; a temperature sensor; and a CO2 sensor.

[0099] One form of this technology includes a system for diagnosing and / or monitoring respiratory disorders, the system comprising: a patient interface according to any of the foregoing aspects or examples; and at least one computing device communicating with the patient interface to receive data from one or more sensors of the patient interface.

[0100] Another aspect of this technology is a patient interface, which is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0101] One aspect of this technology is a method for manufacturing equipment.

[0102] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for people without medical training, those who are clumsy, have limited vision, or have limited experience in using this type of medical device.

[0103] One aspect of this technology is a portable RPT device that can be carried by an individual (e.g., around a personal home).

[0104] One aspect of this technology is a patient interface that can be cleaned at home, for example, in soapy water, without requiring specialized cleaning equipment. Another aspect of this technology is a humidifier tank that can be cleaned at home (e.g., in soapy water) without requiring specialized cleaning equipment.

[0105] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors, such as processors for dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0106] Of course, the parts of each aspect can form sub-aspects of the present invention. Sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of the present invention.

[0107] Other features of the invention will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims. Attached Figure Description This technology is illustrated in the accompanying drawings by way of example rather than limitation, wherein the same reference numerals denote similar elements, including: 4.1 Respiratory Therapy System Figure 1A A system is shown in which a patient 1000, wearing a patient interface 3000 via a nose pillow, receives a positive-pressure air supply from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient sleeps in a supine position.

[0108] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0109] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying position.

[0110] 4.2 Respiratory System and Facial Anatomy Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0111] Figure 2B This diagram shows a view of the human upper airway, including the nasal chambers, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper and lower lips, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0112] Figure 2C It is a front view of the face with several marked surface anatomical features, including the upper lip, upper vermilion border, lower vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0113] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, lower nasal septum, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, upper auricular base, and lower auricular base. The vertical and anteroposterior directions are also marked.

[0114] Figure 2E This is another side view of the head. The approximate locations of the Frankfurt plane and the nasolabial angle are indicated. The coronal plane is also shown.

[0115] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial groove, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and midsagittal plane.

[0116] Figure 2G A side view showing the surface features of the nose is shown.

[0117] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0118] Figure 2I The diagram shows the medial anatomy of the nose a few millimeters from the midsagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0119] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal turbinate bones, as well as the maxilla and mandible, are also labeled.

[0120] Figure 2K A side view of the skull showing the surface contours of the head and several muscles is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0121] Figure 2L The frontal lateral view of the nose is shown.

[0122] 4.3 Patient Interface Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0123] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0124] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0125] Figure 3D A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a zero value.

[0126] Figure 3E A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0127] Figure 3FA schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0128] Figure 3G The padding of a face mask including two pillows is shown. The outer surface of the padding is indicated. The edges of the surface are indicated. The dome-shaped and saddle-shaped areas are indicated.

[0129] Figure 3H The padding used for the face mask is shown. The outer surface of the padding is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle-shaped areas and one dome-shaped area are indicated.

[0130] Figure 3I The diagram shows a surface with a structure having a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.

[0131] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface shown is in Figure 3I The structure defines a two-dimensional hole.

[0132] Figure 3K It shows Figure 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is... Figure 3I The surface of the two-dimensional hole is defined in the structure.

[0133] Figure 3L A face mask with an inflatable airbag as padding is shown.

[0134] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the airbag is also shown. This inner surface defines a two-dimensional aperture in the mask.

[0135] Figure 3N It shows crossing Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0136] Figure 3O The left-hand rule is illustrated.

[0137] Figure 3P The right-hand rule is illustrated.

[0138] Figure 3Q The left ear is shown, including the left helix.

[0139] Figure 3R The right ear is shown, including the right earlobe.

[0140] Figure 3S A right-handed spiral is shown.

[0141] Figure 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the face mask.

[0142] Figure 3U A view of the pneumatic chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0143] Figure 3V It shows Figure 3U This is a view of the rear of the pneumatic chamber. The direction of this view is perpendicular to the intermediate contact plane. Figure 3V The sagittal plane in the middle divides the pneumatic chamber into two equal parts, left and right.

[0144] Figure 3W It shows crossing Figure 3V The cross-section of the pneumatic chamber, which is in Figure 3V The image shows a section taken at the sagittal plane. An "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The direction of the intermediate contact plane corresponds to the direction of chord 3210, which lies in the sagittal plane and contacts the pneumatic chamber liner at the following two points in the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the liner in this region, the intermediate contact plane can be a tangent at the upper and lower points.

[0145] Figure 3X It shows Figure 3U The pneumatic chamber 3200 is positioned on the face during use. When the pneumatic chamber is in the use position, the sagittal plane of the pneumatic chamber 3200 approximately coincides with the mid-sagittal plane of the face. When the pneumatic chamber is in the use position, the intermediate contact plane generally corresponds to the 'facial plane'. Figure 3X In the middle, the air chamber 3200 is the air chamber of the nasal mask, and the upper point 3220 is roughly located on the bridge of the nose, while the lower point 3230 is located on the upper part of the lips.

[0146] Figure 4A This is a front perspective view of a form of positioning and stabilizing structure for a patient interface, according to this technology.

[0147] Figure 4B This is a side view of a patient interface according to one form of the present technology, which incorporates... Figure 4A The positioning and stabilizing structure is shown, illustrating its use on the patient's head.

[0148] Figure 4C yes Figure 4B The front perspective view of the patient interface shows its usage location on the patient's head.

[0149] Figure 4D It's a diagram. Figure 4A A close-up view of the positioning and support area of ​​the stabilizing structure.

[0150] Figure 4E yes Figure 4A The positioning and stabilizing structure is shown in the side view of the patient wearing the device in the first configuration.

[0151] Figure 4F yes Figure 4A The positioning and stabilizing structure is shown in the side view of the patient wearing the device in the second configuration.

[0152] Figure 5A This is a side view of a form of patient interface according to the present technology, showing its usage position on the patient's head.

[0153] Figure 5B It is used to connect the sealing element to the structure. Figure 5A A schematic diagram of the patient interface positioning and stabilizing structure mechanism.

[0154] Figure 6 This is a front perspective view of a form of patient interface according to the present technology, showing the usage location on the patient's head.

[0155] Figure 7A This is a side view of a form of patient interface according to the present technology, showing its usage position on the patient's head.

[0156] Figure 7B It is used to connect the sealing element to the structure. Figure 7A A schematic diagram of the patient interface positioning and stabilizing structure mechanism.

[0157] Figure 7C yes Figure 7A The front perspective view of the patient interface shows its usage location on the patient's head.

[0158] Figure 8A This is a front perspective view of a form of patient interface according to the present technology, showing the usage location on the patient's head.

[0159] Figure 8B yes Figure 8A A close-up side view of the pneumatic chamber of the patient interface.

[0160] Figure 9A The positioning and stabilization structure of a patient interface in a first use position on a patient's head according to the present technology is shown.

[0161] Figure 9B It shows Figure 9AThe positioning and stabilizing structure, which serves as part of the patient interface, is located in a second usage position on the patient's head.

[0162] Figure 9C Is it through Figure 9A A schematic cross-section of a part of the positioning and stabilizing structure.

[0163] 4.4 RPT device Figure 10A An RPT device of one form according to the present technology is shown.

[0164] Figure 10B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface as downstream of the blower, regardless of the actual flow direction at any given moment. Articles within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0165] Figure 10C This is a schematic diagram of the electrical components of one form of RPT device according to the present technology.

[0166] Figure 10D This is a schematic diagram of an algorithm implemented in an RPT device according to one form of this technology.

[0167] Figure 10E The illustration shows a form according to this technology. Figure 10D The flowchart shows the method executed by the treatment engine module.

[0168] 4.5 Humidifier Figure 11A An isometric view of one form of humidifier according to the present technology is shown.

[0169] Figure 11B An isometric view of one form of humidifier according to the present technology is shown, illustrating the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0170] Figure 11C A schematic diagram of one form of humidifier according to the present technology is shown. Detailed Implementation Before describing this technology in more detail, it should be understood that this technology is not limited to the specific examples that may vary as described herein. It should also be understood that the terminology used in this invention is for the purpose of describing the specific examples discussed herein and is not intended to be limiting.

[0171] The following description provides various examples of items that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. Furthermore, in any example, any single feature or combination of features can form another example.

[0172] 5.1 Treatment In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0173] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0174] In some examples of this technology, mouth breathing is restricted, constrained, or prevented.

[0175] 5.2 Respiratory Therapy System In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0176] 5.3 Patient Interface refer to Figure 3A According to one aspect of the present technology, the noninvasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, a pneumatic chamber 3200, a positioning and stabilizing structure 3300, an airway 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the airway inlet of the patient 1000. The sealed patient interface 3000 is therefore suitable for the delivery of positive pressure therapy.

[0177] Other examples of non-invasive patient interfaces 6000, 7000, 8000, 9000, 10000, and 11000 are also available. Figures 4A-4F The figures are shown in 5A-5B, 6, 7A-7C, 8A-8B and 9A-9C, and will be described in further detail below.

[0178] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0179] One form of patient interface according to this technology is constructed and arranged to provide air at a positive pressure of at least 6 cmH2O relative to the environment.

[0180] One form of patient interface according to this technology is constructed and arranged to provide air at a positive pressure of at least 10 cmH2O relative to the environment.

[0181] One form of patient interface according to this technology is constructed and arranged to provide air at a positive pressure of at least 20 cmH2O relative to the environment.

[0182] 5.3.1 Sealing Formation Structure In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The area where a seal actually occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0183] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0184] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material (e.g., silicone rubber).

[0185] The sealing structure 3100 according to this technology can be constructed from a soft, flexible and resilient material such as silicone.

[0186] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each of which is configured to correspond to a different size and / or shape range. For example, the system may include one type of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0187] 5.3.1.1 Sealing Mechanism In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure within the pneumatic chamber 3200, acting on its underside to induce a tight seal between the sealing flange and the face. This pressure-assisted mechanism can work in conjunction with elastic tension within the positioning and stabilizing structure.

[0188] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the pneumatic chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the pneumatic chamber 3200 and extends for at least a portion of the path around the circumference. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from bending during use.

[0189] In one form, the sealing structure may include a compression seal or a gasket seal. In use, the compression seal or the gasket seal is constructed and positioned in a compressed state, for example, as a result of elastic tension in the positioning and stabilizing structure.

[0190] In one form, the sealing structure includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by adjacent areas of the sealing flange.

[0191] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0192] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tensioning portion, and a portion having an adhesive or bonding surface.

[0193] 5.3.1.2 Nasal bridge or nasal ridge area In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the bridge or ridge of the nose of the patient's face during use.

[0194] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the bridge or ridge of the nose of a patient's face.

[0195] 5.3.1.3 Upper lip area In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face during use.

[0196] In one embodiment, the sealing structure includes a saddle-shaped region configured to form a seal on the upper lip region of a patient's face during use.

[0197] 5.3.1.4 Chin area In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the chin region of the patient's face during use.

[0198] In one form, the sealing structure includes a saddle-shaped region configured to form a seal on the chin area of ​​the patient's face during use.

[0199] 5.3.1.5 Forehead area In one form, the sealing structure forms a seal on the forehead area of ​​the patient's face during use. In this form, the pneumatic chamber can cover the eyes during use.

[0200] 5.3.1.6 Nasal pillow In one embodiment, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is configured and arranged to form a seal with the corresponding nostril of the patient's nose.

[0201] A nasal pillow according to one aspect of the present technology includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Furthermore, the nasal pillow-connecting structure of the present technology includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of the truncated cone and the nasal pillow-connecting structure in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the handle-connecting structure.

[0202] 5.3.2 Pneumatic Chamber In the area forming a seal during use, the pneumatic chamber 3200 has a periphery whose shape complements the surface contour of a typical human face. During use, the boundary edges of the pneumatic chamber 3200 are positioned very close to the adjacent surface of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 can extend around the entire periphery of the pneumatic chamber 3200 during use. In some forms, both the pneumatic chamber 3200 and the sealing structure 3100 are formed from a single, uniform sheet of material.

[0203] In some forms of this technology, the pneumatic chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the pneumatic chamber. Such forms tend to be less conspicuous and / or more comfortable for the wearer, which can improve treatment adherence.

[0204] In some forms of this technology, the pneumatic chamber 3200 is made of a transparent material, such as transparent polycarbonate. The use of transparent materials can reduce obstruction of the patient interface and help improve treatment adherence. Using transparent materials can help clinicians observe how the patient interface is positioned and functions.

[0205] In some forms of this technology, the pneumatic chamber 3200 is made of a translucent material. The use of a translucent material can reduce the protrusion of the patient interface and help improve treatment adherence.

[0206] 5.3.3 Positioning and Stabilizing Structure The patient interfaces of this technology 3000, 6000, 7000, 8000, 9000, 10000, and 11000 are sealed by structures 3100, 6100, 7100, 8100, 9100, 10100, and 11100, which can be kept in a sealed position during use by positioning and stabilizing structures 3300, 6300, 7300, 8300, 9300, 10300, and 11300.

[0207] In one configuration, the positioning and stabilizing structures 3300, 6300, 7300, 8300, 9300, 10300, and 11300 provide a holding force that is at least sufficient to overcome the positive pressure in the pneumatic chambers 3200, 6200, 7200, 8200, 10200, and 11200 to lift the face away.

[0208] In one form, positioning and stabilizing structures provide holding forces to overcome the gravitational effects at the patient interface.

[0209] In one form, the positioning and stabilizing structure provides holding forces as a safety margin to overcome the potential effects of destructive forces at the patient interface, such as from tube drag or accidental interference with the patient interface.

[0210] In one form of this technology, a positioning and stabilizing structure is provided, configured in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilizing structure has a small side or cross-sectional thickness to reduce the sensing or actual volume of the device. In one example, the positioning and stabilizing structure includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilizing structure includes at least one flat strap.

[0211] In one form of this technology, a positioning and stabilizing structure is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a supine sleeping position, wherein the back area of ​​the patient's head rests on a pillow.

[0212] In one form of this technology, a positioning and stabilizing structure is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a side-sleeping position, wherein the lateral area of ​​the patient's head is on the pillow.

[0213] In one form of this technology, the positioning and stabilizing structure comprises a strap constructed from a laminate consisting of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. Alternatively or additionally, the strap may include fibrous fillers (e.g., polyester fiber fillers), nonwoven fillers, foam fillers, high-density interior decorating foam, compressed polyester, medium-density polyurethane antimicrobial foam, high-density polyurethane foam, quick-drying open-cell foam, or combinations thereof. Therefore, the strap is not too large or bulky to prevent the patient from lying in a lateral position. Furthermore, the strap is stretchable and flexible.

[0214] In some forms of this technology, the positioning and stabilizing structure includes a strap that is extendable, for example, elastically extendable. For instance, the strap may be configured to be taut during use and to guide forces to create a seal-forming structure that makes suffocating contact with a portion of the patient's face.

[0215] For example, refer to Figures 4A-4F The patient interface 6000 includes a positioning and stabilizing structure or headband 6300, which includes an upper fabric portion 6310 having a peripheral band for fitting to a patient's head in use. A first lower fabric portion 6320 is movably (e.g., hinged, pivotally, etc.) connected to the upper fabric portion 6310. For example, the first lower fabric portion 6320 may be integral with the upper fabric portion 6310. Alternatively, the first lower fabric portion 6320 may be connected to the upper fabric portion 6310, for example, by stitching, ultrasonic welding, or other techniques. For example, the respective ends of the first lower fabric portion 6320 may be joined at corresponding seams 6322 and 6324 near bifurcation points 6312 and 6314 on opposite lateral sides of the positioning and stabilizing structure 6300. Because the fabric portions 6310 and 6320 are stretchable, the length of each portion in use is equal to or greater than its respective rest length. Therefore, some wrinkles in the fabric materials of 6310 and 6320 are avoided.

[0216] Positioning and stabilizing structure 6300 is used to apply force to sealing forming structure 6100. Sealing forming structure 6100 may be a gasketed mask having a pneumatic chamber 6200 and a connection port 6600 for connecting the pneumatic chamber 6200 to an air circuit 4170.

[0217] In this example, the positioning and stabilizing structure 6300 is formed as a band having a front or anterior segment 6302 and a rear or posterior segment 6304, wherein the front segment 6302 forks (at points 6312, 6314), such that the first fork forms a first portion of the upper fabric portion 6310 and the second fork forms a first lower fabric portion 6320. Therefore, the upper fabric portion 6310 forms a first band or strap that can be wrapped around the patient's forehead during use, such as... Figure 4B As shown, the first lower fabric portion 6320 forms a downwardly stretchable second strap or bandage to engage directly or indirectly with the sealing structure 6100, thereby providing a force to hold the sealing structure 6100 in a therapeutically effective position on the patient's head.

[0218] In some forms, the front section 6302 may have substantially the same width as the rear section 6304. In other words, the width of 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 allows the positioning and stabilizing structure 6300 to have a substantially constant material width at any point along the positioning and stabilizing structure 6300.

[0219] Figures 4A-4F The configuration allows for the positioning and stabilization of structure 6300 as a headband, wherein both fabric portions 6310 and 6320 surround the patient's forehead, allowing the patient to become accustomed to the feel of structure 6300 before treatment begins. 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 the front portion of the patient's head, and the rear section (or rear portion) of the upper fabric portion 6310 is configured to engage the rear portion of the patient's head. Similarly, the lower fabric portion 6320 can be configured to surround the patient's forehead such that the rear section (or rear portion) of the first lower fabric portion 6320 is configured to engage the rear portion of the patient's head. In this first position, the front section of the upper fabric portion 6310 (i.e., forming part of the front section 6302) and the lower fabric portion 6320 can be positioned on the patient's forehead close to each other (e.g., adjacent, close together, etc.). In use, the front section (or front portion) of the first lower fabric portion 6320 is configured to move to a second position and cover the cheek area of ​​the patient's face, preferably the upper cheek area, and extend between the top of the patient's ear and the patient's eye. Furthermore, before treatment begins, the first lower fabric portion 6320 can be easily pulled down (e.g., Figure 4E and Figure 4F (as depicted by the dashed outline in the image), thus it can engage with the pneumatic chamber 6200, for example, by being nested within the external groove or channel 6210 of the pneumatic chamber 6200, and provide tension to the pneumatic chamber 6200 (e.g., Figure 4B-4D(As depicted). In the second position, the first lower fabric portion 6320 can be positioned close to the patient's mouth (e.g., covering the upper part of the patient's lips), while the upper fabric portion 6310 can be held in substantially the same position (e.g., on the patient's forehead), such that the first lower fabric portion 6320 is at least partially spaced apart from the upper fabric portion. For example, the bifurcated segments of the front section 6302 can be spaced apart from each other (e.g., to allow the patient's head to retract and avoid obstructing the patient's eyes). However, the front section 6302 and the rear section 6304 remain continuously formed in the second position, and the combined width of the spaced-apart front section 6302 remains substantially equal to the width of the rear section 6304. Before treatment begins, the positioning and stabilizing structure 6300 can be worn without connecting the air circuit 4170 and / or without activating the pressure generator 4140 of the RPT device 4000. This allows the patient to become accustomed to wearing the patient interface 6000 without experiencing any discomfort from the positive pressure provided by the pressure generator 4140. Therefore, patients can gradually transition to respiratory therapy, which increases the likelihood of compliance once treatment actually begins.

[0220] Therefore, the positioning and stabilization structure 6300 can be easily switched between a first part or non-therapeutic configuration (e.g., for monitoring and / or diagnostic purposes when sensors are provided in the positioning and stabilization structure 6300, as will be discussed below) and a second position or therapeutic or pre-therapeutic configuration by simple pivoting movements.

[0221] Some forms of this technology may include a padding structure attached to or integrated with either or both of the upper fabric portion 6310 and the lower fabric portion 6320. This padding structure may include soft foam or soft woven and / or knitted fabric or nonwoven fabric integrated into or secured 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 exterior of the upper fabric portion 6310 and / or the lower fabric portion 6320. This padding structure provides improved comfort for the wearer.

[0222] In some forms of this technology, the lower fabric portion 6320 can be more stretchable than the upper fabric portion 6310, thus making it easier for the lower fabric portion 6320 to be stretched downwards, such as... Figure 4F As illustrated, this is for engagement with the pneumatic chamber 6200. For example, the tensile properties of portions 6310 and 6320 can be adjusted by employing different types of knitting, such as warp knitting, weft knitting, or a combination of both. In one example, a narrow double-knit warp-knitted fabric may be used to form the lower fabric portion 6320 or at least a portion thereof to provide additional stretch and length relative to the upper fabric portion 6310 for engagement with the pneumatic chamber 6200.

[0223] The upper fabric portion 6310 and the lower fabric portion 6320 can be made of the same fabric (or woven material). The fabric can be nylon, polyester, polypropylene (PP), elastic fiber, or any combination of two or more thereof. The elasticity can be changed by altering the combination of fabric materials (i.e., the blending ratio), yarn count, yarn density, yarn size, and / or the steps and conditions of the process used to manufacture the fabric.

[0224] The fabric may include a core yarn comprising a core and a covering layer. The core yarn may contain polyurethane fibers and / or elastomer fibers (such as rubber fibers and silicone fibers) to achieve the desired tensile strength, while the covering layer may be made of nylon, polyester, and / or polypropylene. Furthermore, the filaments used for the covering layer may be textured continuous filaments to achieve better softness, durability, better thermal insulation, high permeability, and good moisture transport (i.e., moisture wicking).

[0225] The width of both the upper fabric portion 6310 and the lower fabric portion 6320 can be less than 40 mm. In some forms, the width is less than 30 mm. The width can be greater than 3 mm. Fabric portions 6310 and 6320 can have different widths. For example, the upper fabric portion 6310 can be wider to accommodate the sensor and circuitry (e.g., greater than 10 mm and less than 30 mm, or greater than 15 mm and less than 25 mm), and the lower fabric portion 6320 can be narrower to avoid visual obstruction (e.g., less than 10 mm, or less than 15 mm).

[0226] The upper fabric portion 6310 can be arranged to have lower stretchability and greater thickness than the lower fabric portion 6320 to ensure that the upper fabric portion 6310 maintains its shape, while the lower fabric portion 6320 is arranged to be more easily stretched downwards (wherein the pneumatic chamber 6200 is held in place for use). For example, the thickness of the fabric used for the upper fabric portion 6310 can be in the range of about 0.30 mm to about 1.50 mm, and the thickness of the fabric used for the lower fabric portion 6320 can be in the range of about 0.20 mm to about 1.00 mm.

[0227] The positioning and stabilizing structure 6300 can be constructed by weaving a strip of material with bifurcations at 6312 and 6314, and the ends of the strip can be attached (as shown in the image). Figure 4A (as shown at the joint 6332) to form a positioning and stabilizing structure 6300.

[0228] In some embodiments, two separate portions may be woven together and then attached together by any suitable means. For example, a first (upper) peripheral band may be joined to a second (lower) peripheral band by a joining section or seam extending partially around its respective circumference, leaving at least one unjoined section of the two bands separable (e.g., spanning between bifurcation points 6312 and 6314, or between seams 6322 and 6324). The first and second peripheral bands may be formed of different textile materials and / or may have different degrees of stretch. The joining between the two portions may be formed by knitting, sewing, adhesives (including adhesive patches, which may be rigid or elastically deformable), ultrasonic bonding, heat sealing, or any combination of two of these.

[0229] In some forms of this technology, the degree of tension or rigidity of the first lower fabric portion 6320 can vary along its length. For example, as Figure 4D As depicted, the middle section 6326 of the first lower fabric portion 6320, arranged to directly engage with the pneumatic chamber 6200 (e.g., within its recess 6210), can be more rigid than the rest of the first lower fabric portion 6320 to provide greater support at the direct engagement point. The other portions of the first lower fabric portion 6320 can be rigid to provide greater stability to the headband 6300 during use and / or to change the direction of tension to prevent the first lower fabric portion 6320 from traveling upwards over the patient's cheekbone and covering the eyes.

[0230] In some forms of this technology, one or more rigid elements may be provided to selectively alter the rigidity of the first lower fabric portion 6320. These may be attached to the first lower fabric portion 6320 or inserted between its layers. For example, the intermediate segment 6326 may include rigid elements laminated to or embedded between the layers of the lower fabric portion 6320. Alternatively, thermosetting yarns may be used to provide selective rigidification in the intermediate segment 6326. The fabric may also be rigidified at other portions of the lower fabric portion 6320, such as along lateral segments that will come into contact with the patient's face during use, for example, using coatings, laminations, rigidification threads sewn into the fabric, or any similar means.

[0231] In some forms, the positioning and stabilizing structure may include a patient contact structure having one or more elastic straps extending therefrom to engage with a strap that holds the sealing-forming structure in place.

[0232] For example, such as Figure 5AAs shown, the patient interface 7000 includes a positioning and stabilizing structure 7300, which in turn includes a patient contact structure 7301 that cooperates with a shoulder strap 7329 to provide tension to a seal-forming structure 7100 to hold the seal-forming structure 7100 in a therapeutically effective position on the patient's head. The patient interface 7000 also includes a pneumatic chamber 7200 having a connection port 7600 for connecting the patient interface 7000 to an air circuit 4170.

[0233] In one form of this technology, the positioning and stabilizing structure 7300 includes an upper fabric portion 7310 and two lower fabric portions movably (e.g., hinged, pivotally connected, etc.) connected to the upper fabric portion 7310. The positioning and stabilizing structure 7300 also includes a rear section 7304 configured to anchor against the posterior surface of the patient's neck. The upper fabric portion 7310 is adapted to wrap around the patient's head in use in an area above an ear-based point on the patient's head.

[0234] The lower fabric portion may include a first arm 7326 and a second arm 7328. Each arm may have a hook, such as a hook 7349 extending from the second arm 7328. Figure 5B This allows it to engage with a corresponding clip 7330 located on the carrying strap 7329. For example, the hook 7349 can be formed from a section of elastic yarn material, with its opposite ends 7346, 7348 located within corresponding channels 7342 and 7344 on the second arm 7328. By forming the hook 7349 from an elastic material, it can easily extend to engage with the clip 7330, while also being able to retract into the channels 7342, 7344 when the patient interface 7000 is not in use and the attached sealing structure 7100 is not required. Although not in Figure 5A and 5B As specifically shown, but will be understood, the same (or similar) structure may be provided on the first arm 7326 to engage with additional clips on the opposite side of the carrying strap 7329, such that the two hook-and-clip pairs cooperate to hold the carrying strap 7329 and thus the sealing-forming structure 7100 in the proper position on the patient's head.

[0235] Hook 7349 Figure 5A and Figure 5B The second arm 7328 is shown extending from its outer (non-patient contact) surface. It should be understood that in some forms of this technology, the hook 7349 may alternatively extend from a channel located on the inner (patient contact) surface of the second arm 7328, although it is generally desirable to use a channel such as... Figure 5A and Figure 5B The external layout shown is designed to make the patient more comfortable.

[0236] The first arm 7326 and the second arm 7328 may each vary in stiffness relative to at least a portion of the upper fabric portion 7310 and the rear portion 7304 of the patient contact structure 7301 along its length. For example, each of the first arm 7326 and the second arm 7328 may be stiffer than the upper fabric portion 7310 and the rear portion 7304, at least in its middle section. By providing increased stiffness in at least the middle sections of the two arms 7326, 7328, the positioning and stabilizing structure 7300 provides increased support for the seal-forming structure 7100, making it less prone to movement during respiratory therapy and providing a better dynamic seal. Furthermore, similar to the stiffening of the positioning and stabilizing structure 6300 described above, selectively increasing the stiffness in the arms 7326, 7328 helps to guide the tension vector away from the patient's eye during use. In some embodiments, the arms 7326, 7328 may be formed using thermosetting yarns to provide the desired stiffness.

[0237] In one embodiment, one or more rigid members may be provided in the arms 7326, 7328. The rigid members may be semi-rigid. In other words, the rigid members may be stiffer than, but not completely stiff, than the fabric material used to form the arms 7326, 7328 and / or the upper fabric portion 7310. This allows them to provide structure for the arms 7326, 7328, but they are flexible enough to bend. Patients and / or medical professionals can adjust or bend the rigid members to provide customized support for individual patients. The rigid members may also begin as semi-rigid (in other words, the rigid members may be semi-rigid at the beginning or initially) and may become rigid after a period of time. For example, medical professionals may adjust the shape of the rigid members so that the positioning and stabilizing structure 7300 is adapted to the face of an individual patient. The rigid members may then be treated (e.g., heat-treated) to set them to their shape. In other words, the rigidity of the rigid members can be changed. Therefore, the rigidity of the arms 7326, 7328 also changes and can be selectively increased to provide customized support for individual patients (or multiple patients).

[0238] In one form of this technology, such as Figure 6 As shown, the patient interface 8000 includes a sealing formation structure 8100, which includes one or more clips 8220 that can engage with corresponding hooks on the positioning and stabilizing structure 7300 to hold the sealing formation structure 8100 in a therapeutically effective position on the patient's head. For example, a patient contact structure 7301 of the positioning and stabilizing structure 7300 can cooperate with this sealing formation structure 8100 to form the patient interface 8000, which also includes a pneumatic chamber 8200 and a connection port 8600 for connection to an air circuit 4170. Therefore, the patient contact structure 7301 can be coupled with intermediate structures such as... Figure 5A and Figure 5B The strap shown is used in conjunction with the sealing structure to maintain the sealing structure, or it can be directly engaged with the sealing structure (wherein the sealing structure includes a suitable engagement mechanism, such as the clip 8220 of structure 8100). The advantage of the strap-type configuration is that it can be used with many types of existing sealing structures 7100, while... Figure 6 The advantage of the structure is that, due to its direct engagement with the sealing structure 8100, it can provide more stable support for the sealing structure 8100.

[0239] In some embodiments, a plurality of clips 8220 may be provided at multiple different locations on the sealing forming structure 8100, or on another structure (such as a pneumatic chamber 8200) attached thereto, such that the tension in the positioning and stabilizing structure 7300 can be adjusted by attaching hooks 7349 to the clips 8220 at different locations. Similarly, for this purpose, [the following can be done / contained / etc.]. Figure 5A and 5B Multiple clips 7330 are provided at multiple different locations on the shoulder strap 7329.

[0240] In another form of this technology, such as Figures 7A-7C As shown, the patient interface 9000 includes a positioning and stabilizing structure 9300, which in turn includes a patient contact structure 9301 that cooperates with a shoulder strap 9329 to provide tension to a sealing structure 9100 to hold the sealing structure 9100 in a therapeutically effective position on the patient's head. The patient interface 9000 also includes a pneumatic chamber 9200 having a connection port 9600 for connecting the patient interface 9000 to an 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 shoulder strap 9329 to the patient contact structure 9301.

[0241] In one form of this technology, the positioning and stabilizing structure 9300 includes an upper fabric portion 9310 and a lower fabric portion, the lower fabric portion being movably (e.g., hinged, pivotally connected, etc.) to (e.g., integral with) and extending from the upper fabric portion 9310. The positioning and stabilizing structure 9300 also includes a rear portion 9304 configured to anchor against the posterior surface of the patient's neck or occipital bone. The upper fabric portion 9310 is adapted to wrap around the patient's head in the region of the supraaural abutment above the patient's head during use.

[0242] The lower fabric portion may include a first arm 9326 and a second arm 9328. Each arm may have a hook, for example, from the second arm 9328 ( Figure 7BThe extended hook 9349 engages with a corresponding hook (not shown) located on the carrying strap 9329. For example, the hook 9349 may be an elastic band that is received in a channel 9342 on the outer (non-patient contact) surface of the second arm 9328, and it may extend from the channel 9342 to engage with a clip on the carrying strap 9329. When the band 9349 is released, it retracts at least partially into the channel 9342.

[0243] The strap 9349 can be attached to the carrier 9329 via a hook-and-loop arrangement. For example, a first patch with hooks (or loops) on its surface can be provided on the strap 9349, and a second patch with loops (or hooks) on its surface can be provided on the carrier 9329, allowing the patient to attach the strap 9349 to the carrier 9329 by contacting the first patch with the second patch. Furthermore, tension can be adjusted by changing the relative positions of the first and second patches upon contact. The hook-and-loop arrangement may include hook components comprising nanoscale protrusions and loop components comprising nanofiber stacked fabric. One such hook-and-loop system is marketed by Teijin under the trademark FASTENANO. In another possible arrangement, the strap 9349 may include an array of spikes or similar protrusions that can be embedded in the material of the carrier 9329 for attachment to the carrier.

[0244] Although not in Figures 7A-7C As specifically shown, but it should be understood that the same (or similar) structure may be provided on the first arm 9326 to engage with another clip on the opposite side of the carrying strap 9329, such that the two hook clips cooperate to hold the carrying strap 9329 and the sealing forming structure 9100 in the proper position on the patient's head.

[0245] The first arm 9326 and the second arm 9328 may each vary in rigidity relative to at least a portion of the first elastic fabric portion 9310 and the rear portion 9304 of the patient contact structure 9301 along its length. For example, each of the first arm 9326 and the second arm 9328 may be more rigid than the first elastic fabric portion 9310 and the rear portion 9304, at least in its intermediate section. By providing increased rigidity in at least the intermediate sections of the two arms 9326, 9328, the positioning and stabilizing structure 9300 provides increased support for the sealing-forming structure 9100, making it less prone to movement during respiratory therapy. Advantageously, the arms 9326, 9328 may be formed using thermosetting yarns to provide the desired rigidity. Alternatively or additionally, similar rigidification mechanisms as discussed above may be employed, such as providing rigid elements attached to or embedded between the layers of the arms 9326, 9328.

[0246] In another form of this technology, such as Figure 8A and 8BAs shown, the patient interface 10000 includes a positioning and stabilizing structure 10300 and a pneumatic chamber 10200 having a connection port 10600 for connecting the patient interface 10000 to an air circuit 4170. The positioning and stabilizing structure 10300 is configured and arranged to provide force to hold the sealing formation structure 10100 of the patient interface in a therapeutically effective position on the patient's head.

[0247] In one form of this technology, the positioning and stabilizing structure 10300 includes an upper fabric portion 10310 and a lower fabric portion, the lower fabric portion being movably (e.g., hinged, pivotally connected, etc.) connected (e.g., integral with and extending from the first elastic fabric portion 10310). The positioning and stabilizing structure 10300 also includes a rear portion 10304 configured to anchor against the posterior surface of the patient's neck. The first elastic fabric portion 10310 is adapted to wrap around the patient's head in use, for example, in the area above the ear base point on the patient's head.

[0248] 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 to a pneumatic chamber 10200 in use to hold the sealing formation 10100 in place. For example, the pneumatic chamber 10200 may have a first wing (not shown) and a second wing 10220 extending therefrom, each wing adapted to be coupled to a corresponding arm 10326, 10328. For example, each wing may carry a portion of a fastener, such as a button, clip, etc., adapted to mate with a corresponding portion on the corresponding 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 for reference positioning and stabilizing structures 7300 and 9300. In addition, the wings may have spikes or similar structures that can be inserted into arms 10326 and 10328 for attachment. If the wings are formed of textile material or have a textile outer layer, spikes or similar structures may be carried on the outer or inner surface (facing the patient) of arms 10326 and 10328 to be embedded in the fibers of the textile material of the wings for attachment.

[0249] Wing 10220 can be formed from various materials, such as fabrics, polymers, elastomers, or combinations thereof.

[0250] The first arm 10326 and the second arm 10328 may each vary in stiffness relative to at least a portion of the upper fabric portion 10310 and the rear section 10304 along their length. For example, each of the first arm 10326 and the second arm 10328 may be more rigid than the upper fabric portion 10310 and the rear section 10304, at least in its middle section. The arms 10326, 10328 may be formed using thermosetting yarns to provide the desired stiffness, and / or using one or more rigid elements disposed in or on the arms 10326, 10328. The respective ends of the arms 10326, 10328 that connect to the wing 10220 may have relatively greater elasticity than the middle sections, such that when connected to the wing, they provide the necessary tension to hold the sealing structure 10100 in place.

[0251] In some forms of this technology, a humidity exchanger 10230 may be disposed within the pneumatic chamber 10200. The humidity exchanger 10230 is a passive component located in the flow path for absorbing moisture and heat from the exhaled airflow and transferring it to the inflow airflow. One benefit of including a humidity exchanger 10230 in the pneumatic chamber is that it can reduce or eliminate the need for active humidification, such as by a humidifier 5000. The humidity exchanger 10230 reduces the likelihood of dry mouth, which may be particularly important for patients who are prone to mouth breathing and may therefore suffer discomfort. It should be understood that similar humidity exchangers may be disposed in any other form of pneumatic chamber of the technology described herein.

[0252] In one form of this technology, such as Figure 9A and 9B As shown, the positioning and stabilization structure 11300 of the patient interface 11000 may have an integrated connection port 11600 to facilitate access from, for example, Figure 9A The positioning and stabilizing structures shown are used as the primary position for headband wearing or for switching to a non-therapeutic configuration, as described above. Figure 9B The second position or treatment (or pre-treatment) configuration shown, wherein the positioning and stabilization structure 11300 can be connected via connection port 11600 to an air circuit 4170 communicating with a pneumatic chamber 11200.

[0253] Many different forms of connection are possible between the air circuit 4170 and the connection port 11600, as long as a substantially airtight seal is formed to substantially prevent pressure leakage during treatment. For example, port 11600 may include a magnetic element 11610 located on its inner surface for connection to a corresponding magnetic element on a connector located at one end of the air circuit 4170. In another example, the connector of the air circuit may be attached to the connection port 11600 by a snap-fit ​​engagement (such as a ring snap-fit ​​engagement or a cantilever snap-fit ​​engagement, either of which may be rigid-to-rigid or rigid-to-elastic) or a friction engagement.

[0254] like Figure 9A As shown, the positioning and stabilizing structure 11300 includes an upper fabric portion 11310, which includes an elastic circumferential band for fitting into the patient's head during use. A first lower fabric portion 11320 is movably (e.g., hinged, pivotally, etc.) connected to the upper fabric portion 11310 (e.g., integral with the upper fabric portion 11310) and extends from the upper fabric portion 11310. The positioning and stabilizing structure 11300 is used to apply forces to the sealing forming structure 11100, such as... Figure 9B As shown. The sealing structure 11100 can be a nasal mask with a pneumatic chamber 11200. Other types of masks, such as full-face masks and oronasal masks, can also be used as part of the patient interface along with the positioning and stabilization structure 11300.

[0255] In this example, the positioning and stabilizing structure 11300 is formed as a band having a front (anterior) segment 11302 and a rear (posterior) segment 11304, wherein the front portion 11302 has a first bifurcation segment (spanning between bifurcation points 11312 and 11314), such that the first bifurcation forms a first portion of the upper fabric portion 11310, and a second bifurcation forms a first lower fabric portion 11320. Therefore, the upper fabric portion 11310 forms a first band or strap that can be wrapped around the patient's forehead during use, such as... Figure 9A As shown, the first lower fabric portion 11320 forms a downwardly stretchable second strap or bandage to engage directly or indirectly with the sealing structure 11100, thereby providing a force to hold the sealing structure 11100 in a therapeutically effective position on the patient's head.

[0256] In some forms of this technology, the rear section 11304 may further include a bifurcated section comprising a first rear section 11306 as a second part of the upper fabric portion 11310 and a second rear section 11308 as a second lower fabric portion, such as... Figure 9B As shown. The bifurcation of the posterior segment 11304 enables greater support because it provides tension at a septum location behind or near the patient's head or occipital bone, and also provides greater adjustability, allowing the patient to better position and stabilize structure 11300 for greater comfort. It should be understood that any other form of the posterior segment 6304, 7304, 9304, 10304 of the present technology disclosed herein may also be used with... Figure 9B The positioning and stabilizing structure 11300's rear section 11304 bifurcates in a similar manner.

[0257] In some forms, the rear section 11304 may resemble the previously described front section or front section (e.g., front section 6302). For example, the rear section 11304 may include a width that combines the measured widths of the first rear portion 11306 and the second rear portion 11308. This combined width may be substantially similar to the combined width of a first portion of the first lower fabric portion 11320 and the upper fabric portion 11310 (e.g., together they form the front section 11302).

[0258] The rear section 11304 can move between a first position and a second position. Similarly, when the first rear portion 11306 and the second rear portion 11308 are positioned close to each other, the rear section 11304 can be in the first position. When the first rear portion 11306 and the second rear portion 11308 are spaced apart from each other, the rear section 11304 can be in the second position.

[0259] In some forms (see example) Figure 9A When the first posterior portion 11306 and the second posterior portion 11308 are positioned in the lower part of the patient's head (e.g., covering the occipital bone, near the next part of the patient's head, etc.), the posterior segment 11304 may be in a first position. Alternatively, the first posterior portion 11306 and the second posterior portion 11308 may be positioned slightly higher on the patient's head, such that at least one covers the parietal bone.

[0260] In some forms (see example) Figure 9B When the first rear portion 11306 and the second rear portion 11308 are spaced apart from each other, the rear segment 11304 can be in the second position. When the entire positioning and stabilizing structure 11300 is in the second position, the anterior segment 11304 and the rear portion 11306 can combine to form an X shape when viewed from the side of the patient's head.

[0261] In some forms, the first rear portion 11306 can be moved from a first position to a second position (e.g., over the parietal bone) relative to the second rear portion 11308. In other forms, the second rear portion 11308 can be moved from the first position (e.g., downwards) to the second position relative to the first rear portion 11306. In yet another form, both the first rear portion 11306 and the second rear portion 11308 can be moved away from each other from the first position (e.g., over the parietal bone) to the second position relative to the second rear portion 11308.

[0262] In some forms of this technology, the positioning and stabilizing structure 3300 includes straps that are flexible, for example, non-rigid. An advantage of this is that the straps make it more comfortable for the patient to lie on them while sleeping.

[0263] In some forms of this technology, the positioning and stabilizing structure includes straps configured as breathable to allow moisture to be transferred through the straps. In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide a holding force corresponding to a range of sizes and / or shapes. For example, the system may include one form suitable for large-sized heads but not for small-sized heads, and another form suitable for small-sized heads but not for large-sized heads.

[0264] 5.3.3.1 Arrangement of sensors and actuators for the patient interface In some forms of this 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 actuators may be embedded within the patient interface, for example, between fabric layers of the headband of the patient interface, or may be attached to the inner and / or outer surfaces of the headband or other components of the patient interface. For example, the one or more sensors and / or actuators may be integrated into a positioning and stabilization structure, and / or another component such as a sealing formation structure or a pneumatic chamber.

[0265] In some forms, the headband may include one or more leads, cables, or other conductive elements extending therefrom and electrically connected to one or more sensors or actuators. Each such conductive element may include terminals that can contact the wearer's skin to provide one or more suitable signal grounding points on the wearer's face or head, such as behind the ears or below the eye sockets. This is useful for implementing EEG, EMG, or EOG systems within the headband.

[0266] Sensors embedded in the patient interface help collect sleep-related data and physiological indicators, such as vital signs; this can be used to determine improvements in sleep and health by comparing data before and after treatment. This data can be processed to inform the patient how the treatment improves sleep. For example, the patient can wear a positioning and stabilization structure 11300 with integrated sensors as a headband before starting treatment. Figure 9A As shown, physiological and sleep data can be recorded during the patient's sleep (and during the day, in the case of physiological data). After the start of treatment, the localization and stabilization structure 11300 is in... Figure 9B The treatment configuration shown can record further physiological and sleep data and compare it with data recorded before treatment began. The physiological and sleep data can be transmitted to external computing devices, such as the patient's smartphone, and / or to a monitoring server operated or accessible by a clinician or other healthcare provider.

[0267] Because patients are able to wear the positioning and stabilizing structure 11300 as a headband and receive data-based feedback on how the treatment actually helps (e.g., via an application executed on the patient's smartphone), patient compliance is more likely, resulting in a smoother adaptation. The collected data can also be used to determine group-level sleep and / or physiological characteristics of one or more groups of patients undergoing respiratory therapy, potentially enabling better treatment customization for patients belonging to specific categories or allowing for optimization of the operation of the RPT device 4000.

[0268] In some forms of this technology, the measurement of patient-side functional parameters using sensors integrated in and / or attached to the mask can provide improved, active, feedback-based control of the RPT device 4000 to which the patient interface is connected, such as improved feedback control of the pressure generator 4140 of the RPT device 4000. Figure 10B ).

[0269] For example, refer to Figure 9B and 9C The upper fabric portion 11310 of the positioning and stabilization 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 stabilization structure 11300, typically also within the upper fabric portion 11310; however, it is understood that the processor module 11350 may be located elsewhere within the positioning and stabilization structure 11300. The processor module 11350 may have an integrated transceiver for sending 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 stabilization structure 11300 (sensors / actuators 11354-11360 and processor module 11350).

[0270] like Figure 9C As shown, sensors and associated electronics can be at least partially integrated between the fabric layers of the upper fabric portion 11310. For example, various sensor / actuator modules and / or associated circuitry, processor module 11350, and battery module 11352 can be located between the inner patient contact fabric layer 11370 and the outer non-patient contact fabric layer 11372.

[0271] For example, sensor and / or actuator modules integrated in the positioning and stabilization structure 11300 can electrically communicate with the processor 11350 and battery 11352 via bus 11365. Bus 11365 can be disposed between two insulating layers 11366, which provide electrical insulation and also prevent moisture ingress, such as from sweat absorbed by the inner fabric layer 11370. Insulating layer 11366 can be, for example, a non-conductive polymer or elastomer film, but it should be understood that other electrically insulating materials may also be used.

[0272] In some forms of this technology, a thermally insulating layer may be provided between at least some electronic components of the positioning and stabilizing structure 11300, noting that these components will tend to generate heat during use. Therefore, the thermal insulation layer helps improve patient comfort. For example, layer 11366, which is closest to the patient in contact with inner layer 11370, may be both thermally and electrically insulating, or an additional thermally insulating layer may be inserted between the electrically insulating layer 11366 and inner layer 11370. In some examples, inner layer 11370 itself may be thermally insulating.

[0273] In some forms of this technology, sensor and / or actuator modules 11354-11360 and their associated circuitry, as well as other modules including processor 11350 and battery 11352, can be housed within sensor holding structures 11380-11390 fixed to insulating layer 11366 and / or inner fabric layer 11370. Each sensor holding structure 11380-11390 is electrically in communication with bus 11365, for example, and may include electrical contacts to electrically connect the circuitry of the sensor module (or the circuitry associated with the sensor module) to bus 11365, and thus also electrically to battery 11352 and processor 11350. In some examples, communication between modules 11350-11360 and bus 11365 may be via conductive ink and / or conductive wires woven into or otherwise integrated with fabric layers 11370 and / or 11372. In some embodiments, electrical contacts and / or circuit traces may be contained only in the outer layer 11372 so as to be unaffected by sweat from the patient during use.

[0274] In some examples, modules 11350-11360 may be detachable from sensor holding structures 11380-11390, allowing a particular module to be used for other modules with different functions, or to replace modules that have ceased operation or are at the end of their lifespan. For example, modules 11350-11360 (and / or the circuit modules 11355, 11357, 11359, and 11361 to which they are electrically connected, if applicable) may be releasably attached to sensor holding structures 11380-11390. For this purpose, the outer surface of the module may form a frictional engagement with the inner surface of the wall of sensor holding structures 11380-11390, or may form a snap-fit ​​engagement with the wall or other internal or external portion of the sensor holding structure, such as a ring snap-fit ​​or a cantilever snap-fit. In some embodiments, non-mechanical connections such as magnetic connections may be used to hold modules 11350-11360 in the respective sensor holding structures 11380-11390.

[0275] In some forms of this technology, the sensor holding structure 11380-11390 may include a pocket formed in the upper fabric portion 11310 (e.g., by forming a cut in the outer layer 11372 or the inner layer 11370), into which modules 11350-11360 (or their associated circuitry) may be inserted for electrical connection to bus 11365.

[0276] Battery module 11352 may include a rechargeable battery. The battery can be recharged by connecting it to an external power source, such as via a micro-USB or USB-C port of battery module 11352 (e.g., via a port exposed in the outer fabric layer 11372), or by inductive charging. In some embodiments, battery 11352 may be a disposable battery, for example, disposed within pocket 11382 of the upper fabric portion 11310, and can be removed by the patient for replacement with a new battery.

[0277] In some forms of this technology, one or more sensor modules and / or actuator modules can be completely encapsulated between fabric layers 11370, 11372, such that no part of the one or more sensor modules is exposed. For example, actuator module 11360 can be coupled to associated circuitry 11361 housed in sensor holding structure 11390. Both actuator module 11360 and circuitry 11361 are entirely located between fabric layers 11370, 11372. In another example, sensor module 11356 and associated circuitry 11357 can be entirely located between fabric layers 11370, 11372. An example of a fully embedded sensor module 11356 is an accelerometer or gyroscope.

[0278] In some forms of this technology, the sensor module or actuator module may be at least partially exposed. For example, a humidity sensor 11358 coupled to circuit 11359 may be at least partially exposed to the surrounding environment through an outer fabric layer 11372 to measure the humidity of the patient's environment. For this purpose, the outer fabric layer 11372 may include holes through which the surface of the humidity sensor 11358 may be exposed. In another example, a sensor 11354 coupled to circuit 11355 may have a surface exposed through an inner fabric layer 11370 (e.g., through holes formed therein), such that the sensor surface can contact the patient's skin when the patient wears the positioning and stabilization structure 11300. For example, sensor 11354 may be a pulse oximeter.

[0279] Although the electronic components are described above as having a modular construction and being able to be switched out for other components in at least some cases, in some forms of this technology, one or more electronic components (e.g., sensors or actuators) may be woven or otherwise integrated into the material of the upper fabric portion 11310, such as into the outer fabric layer 11372 or the inner fabric layer 11370, and / or integrated into another portion of the positioning and stabilizing structure 11300, such as the lower fabric portion 11320, and / or one or both of the rear portions 11306, 11308. This allows sensors to be distributed over a larger area for more information and / or more accurate measurements.

[0280] In some forms of this technology, the sensor may include a touch sensor, such as a capacitive or resistive sensor or a tactile switch, and may have associated circuitry enabling the sensor to function as a "pause" button. For example, the touch sensor may be integrated into an exposed area of ​​the positioning and stabilization structure 11300 or the sealing formation structure 11100. In one example, the touch sensor 11358 may be... Figure 9C The touch sensor 11358 is positioned on the upper fabric portion 11310 as shown. The touch sensor 11358 can communicate with the processor / transceiver 11350 as previously described, so that the signals recorded by the touch sensor 11358 and the circuit 11359 can be transmitted by the processor / transceiver 11350 to an external device, such as the pressure generator 4140 of the RPT device 4000.

[0281] For example, if a patient is in the appropriate position with the patient interface 11000 and wishes to speak, or wakes up at night and feels uncomfortable due to the positive pressure in the pneumatic chamber 11200, the patient can activate the "pause" sensor 11358 by light, continuous touches. Circuit 11359 can detect this touch and send a pause signal to the pressure generator 4140 (e.g., via the data communication interface 4280). Figure 10CThis causes the flow rate to immediately decrease to a very low value (e.g., just enough to avoid the feeling of suffocation). When the pause sensor 11358 is released (or reset or reactivated), this is detected by circuit 11359, and another signal is sent to pressure generator 4140 to reset the ramp-up algorithm implemented by RPT device 4000.

[0282] Some forms of this technology may include one or more sensors for determining a patient's sleep position and movement before and / or during respiratory therapy. In some forms, the determined sleep position and movement can be used to regulate the operation of the pressure generator 4140 and / or to provide sensory stimulation to the patient to change position. For example, this could indicate back sleeping if one or more sensors detect that the number of apnea and / or hypopnea events exceeds a certain threshold, and / or that blood oxygenation is reduced (regardless of whether the pressure generator 4140 is operational at this time). One or more actuators may receive an activation signal based on this detection, and this activation signal may cause the one or more actuators to generate vibrations or other tactile stimuli to sufficiently stimulate the patient to cause them to switch to another sleep position.

[0283] For example, the positioning and stabilizing structure 11300 or the sealing forming structure 11100 may include an accelerometer and / or a gyroscope. The accelerometer and / or gyroscope may be completely enclosed between fabric layers 11370 and 11372 of the upper fabric portion 11310, for example... Figure 9C As shown in 11360. Both the accelerometer and gyroscope communicate with the processor / transceiver 11350, so that the data recorded by them can be sent to the RPT device 4000 to regulate the operation of the pressure generator 4140.

[0284] Measurements recorded by the accelerometer can be used to determine the patient's sleep position and adjust treatment accordingly. When the patient is detected to be supine, the pressure generator 4140 can slowly increase the treatment pressure to prevent sleep apnea events. When lateral sleep is detected, the treatment pressure can be decreased. When an upright position is detected (e.g., pre-sleep reading, mask open), the flow and pressure are just sufficient to avoid a feeling of suffocation.

[0285] Measurements recorded by a gyroscope can be used to determine the patient's movement and adjust treatment accordingly. When significant movement is detected, it indicates the patient may be awake, and the treatment pressure can be kept low enough to avoid a feeling of suffocation. As the movement subsides, the treatment pressure can be increased very slowly to avoid discomfort.

[0286] In some forms of this technology, accelerometer and / or gyroscope measurements can be used to determine the patient's sleep stage and accordingly turn the pressure generator 4140 on or off. For example, if treatment begins while the patient is still awake, the patient may have difficulty falling asleep. Therefore, if the accelerometer and / or gyroscope measurements indicate a wakeful or light sleep stage, the pressure generator 4140 can remain "off" or paused, and once the measurements indicate the patient is in a deep sleep stage, the pressure generator 4140 is turned on (typically, with a gradual increase). Conversely, for example, if treatment has begun and it is detected that the patient has switched from deep sleep to light sleep, where the treatment may cause the patient to breathe, the pressure generator 4140 can be paused until the patient is back in deep sleep.

[0287] In some forms of this technology, a pulse oximeter incorporated in the positioning and stabilization structure 11300 can be used to assess sleep health. For example, as... Figure 9C As shown, the pulse oximeter 11354 and associated circuitry 11355 can be integrated into the upper fabric portion 11310 of the positioning and stabilization structure 11300. The pulse oximeter 11354 is exposed through perforations in the inner fabric layer 11370, allowing it to contact the skin of 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 wearing of the patient interface 11000, 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 on-lap or desktop computing system. Time-series data can be used to provide the patient with feedback on their health level and, for example, recommendations for follow-up (by a clinician).

[0288] In one example, the apnea-hypopnea index (AHI) can be determined based on sensor measurements. The AHI is a measure clinicians use to classify the severity of sleep apnea. AHI calculation can use a combination of data from different sensors, such as blood oxygen levels and heart rate (e.g., measured by a PPG sensor), and chest movements (e.g., measured by an accelerometer and / or gyroscope). The AHI value can be used to determine when “apnea” occurs.

[0289] Therefore, by tracking AHI over time, clinicians will be able to tell patients whether they have sleep apnea and provide details of its severity. Furthermore, by analyzing AHI data and other sensor data, clinicians can not only correlate the frequency of apnea with specific sleep positions (e.g., supine or lateral sleep), but also adjust CPAP therapy according to the patient's specific needs. For example, the amount of mouth breathing can be detected using temperature and / or humidity sensors located in the pneumatic chamber at the patient interface, along with a correspondingly prescribed nasal or full-face mask. Additionally, a pressure generator 4140 setting that produces the most suitable flow rate for the patient can be recommended based on sensor measurements. For example, for patients with a high rate of detected apnea or hypopnea events, clinicians can prescribe a higher pressure setting (or equivalently, a higher flow rate). The prescribed flow rate can also depend on the patient's anatomy, such as if the patient has a more collapsible upper airway.

[0290] In some forms of this technology, the EEG sensor can be disposed within the positioning and stabilization structure 11300, for example, in the upper fabric portion 11310. The EEG sensor can be... Figure 9C The module 11354 is partially exposed in a manner shown, allowing contact with the skin of the patient's forehead. Typically, the EEG sensor includes multiple EEG electrodes that generate signals that can be analyzed to detect sleep stages. These signals can be transmitted (via transceiver 11350) to an external device, such as the patient's smartphone, and information on sleep stages, cycles, and durations can be used to provide the patient with feedback on how well sleep therapy is progressing, as well as recommendations for improving health. For example, EEG sensor measurements can be used for accurate sleep staging, enabling more precise determination of when apnea or sleep awakening occurs, such as during sleep studies.

[0291] In some forms of this technology, sleep stage information can be transmitted to the RPT device 4000, so that the pressure generator 4140 can use the sleep stage information to adjust the therapeutic pressure to avoid awakening or blocking events.

[0292] In some forms of this technology, sleep stage information can be used to activate sleep-enhancing white / pink noise and / or binaural beats. These can be generated by an audio device embedded in the patient interface 11000 itself, or by an external device that receives a trigger signal from the patient interface 11000 via a transceiver 11350. For example, one or more miniature bone conduction speakers can be incorporated into the temple area of ​​the upper fabric portion 11310.

[0293] In some forms of this technology, the positioning and stabilization structure 11300 may incorporate electromyography (EMG) and / or electrooculography (EOG) sensors. EMG and EOG sensor signals can be analyzed to determine the occurrence of REM sleep stages. In a manner similar to the example incorporating EEG sensors, the sleep stage information determined by the EMG / EOG sensors can be used to provide feedback to the patient on how well sleep therapy is progressing, and can also be used to adjust the pressure generator 4140 to avoid awakening or blocking events, or to activate one or more audio devices to generate sleep-enhancing noise.

[0294] At least some EMG / EOG sensors can be incorporated into the upper fabric portion 11310. For example, a ground electrode and a reference electrode can be disposed in the upper fabric portion 11310, for example, at its front, and exposed through corresponding holes in the inner layer 11370 to allow contact with the patient's forehead. In another example, the ground electrode can be disposed in the rear portion 11306 of the upper fabric portion 11310, or in the second lower fabric portion 11308, such that the ground electrode is located behind the patient's ear during use. Additional electrodes can be provided, each having a cable attached at one end to the upper fabric portion 11310, the first lower fabric portion 11320, or the second lower fabric portion 11308, and at the other end to an electrode patch that can be positioned by the patient on the temples and below their eyes to provide two additional measurement channels.

[0295] In some forms of this technology, a microphone, such as a MEMS microphone or an electret microphone, can be incorporated into the patient interface 11000 to detect snoring. For example, the microphone may be located in or on the inner surface of the pneumatic chamber 11200, or on its outer surface, adjacent to the patient's nostrils. The microphone may be coupled to a communication interface to transmit data to the pressure generator 4140 of the RPT device 4000 to adjust the resulting pressure. For example, when a light snoring noise pattern is detected, the treatment pressure may be gradually increased to prevent obstruction events. When the snoring noise pattern subsides, the treatment pressure may be decreased.

[0296] In some forms of this technology, the patient interface 11000 may include humidity and temperature sensors, for example, on the inner surface of the pneumatic chamber 11200, to monitor the temperature and humidity within the pneumatic chamber 11200. The sensors may be coupled to a communication interface for transmitting humidity and temperature data to the RPT device 4000 and humidifier 5000 to regulate their operation. The power of the pressure generator 4140 and 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 may be controlled, followed by flushing with normal air while still maintaining a sufficient humidity level (measured by the humidity sensor) to prevent dry mouth.

[0297] In some forms of this technology, a pressure sensor may be disposed within the pneumatic chamber 11200, for example, on its inner surface. This causes the air pressure within the pneumatic chamber 11200 to be adjusted, and sends a signal to the pressure generator 4140 to dynamically regulate the pressure and flow rate. This can optimize the response of the pressure generator 4140 to the patient's breathing pattern.

[0298] In some forms of this technology, a CO2 sensor can be provided within the pneumatic chamber 11200. For example, the CO2 level within the pneumatic chamber 11200 can be monitored. When a slight increase in the CO2 level is detected, the electromechanical vent can be opened. Figures 9A-9C (Not shown) to allow for higher flushing of air from the pneumatic chamber 11200. Additionally, a signal can be sent to the pressure generator 4140 to slightly increase the flow rate of flushing CO2 when the CO2 level increases slightly. This can be done dynamically to minimize patient discomfort.

[0299] In some forms of this technology, a combination of sensors and actuators can be provided to achieve localized temperature changes to improve patient comfort. For example, an EEG sensor and / or pulse oximeter can be disposed in the upper fabric portion 11310 (e.g., with...). Figure 9C (as shown in 11354), and a temperature sensor and / or a humidity sensor may also be disposed in the upper fabric portion 11310 (e.g., to...). Figure 9C (As shown in 11358). Signals from EEG and / or PPG sensors can be analyzed to detect sleep state, and signals from temperature and / or humidity sensors can be used to assess environmental comfort level. One or more Peltier elements can be provided, for example in a wearable form on a wristband, and can be coupled to circuitry communicating with the EEG / PPG and temperature / humidity sensors to receive signals indicating sleep state and environmental comfort level, and to activate the Peltier elements to locally heat or cool the body (e.g., at the wrist) to help the patient maintain a comfortable sleep state.

[0300] In some forms of this technology, haptic feedback elements (such as miniature vibration motors) can be incorporated into the patient interface 11000, for example, in the temple region of the positioning and stabilization structure 11300 (e.g., the upper fabric portion 11310). The haptic feedback elements can deliver vibrations to the patient to produce a calming effect. For example, the processor 11350 can monitor heart rate data from the pulse oximeter 11354 and, if the heart rate data exceeds a threshold, send a trigger signal to the haptic feedback element to cause it to vibrate at a rate several beats lower than the patient's current heart rate, thereby helping to slow the heart rate. In another example, as described above, if the patient is detected to be in a sleep position associated with an apnea or hypopnea event, the haptic feedback element can be used to influence the patient's sleep position.

[0301] In some forms of this technology, one or more miniature thermoelectric generators (TEGs) can be incorporated into the patient interface 11000, such that the difference between the patient's body temperature and the ambient temperature can be used to generate a potential difference and thus provide power to various electronic components (sensors, actuators, processors, etc.) of the patient interface 11000. For example, the miniature TEGs can be located in the upper fabric portion 11310 and exposed through holes in the inner layer 11370, allowing them to contact the patient's forehead.

[0302] In some forms of this technology, multiple sensors can be combined into a single module. For example, an accelerometer and a gyroscope can be combined into a single package.

[0303] Although various sensors and actuators have been described as being combined in Figures 9A-9C The patient interfaces shown are 11000, but it should be understood that they can be incorporated in a similar manner into any other patient interfaces 3000, 6000, 7000, 8000, 9000, 10000 disclosed herein.

[0304] 5.3.4 Vent In one form, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0305] In some configurations, vents 3400 and 10400 are configured to allow continuous ventilation flow from the interior of the pneumatic chamber 3200 to the surrounding environment, while the pressure within the pneumatic chamber is positive relative to the surrounding environment. Vent 3400 is configured such that the vent flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the treatment pressure within the pneumatic chamber during use.

[0306] One form of the vent 3400 or 10400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0307] Vents 3400 and 10400 may be located in pneumatic chambers 3200 and 10200. Alternatively, vents 3400 and 10400 may be located in a decoupling structure (e.g., a rotary joint).

[0308] In some forms, the vent 10400 can be a transparent mesh with a built-in vent.

[0309] Despite Figure 4B-4D Not explicitly shown in 5A-5B, 6, 7A-7C and 8B, but it should be understood that the pneumatic chamber of each example shown in these figures typically also includes a vent capable of flushing CO2 and other exhaled gases.

[0310] In some forms of this technology, vents 3400 and 10400 may be active vents and can be activated based on sensor measurements from one or more sensors from a patient interface (e.g., patient interface 10000). For example, in some forms, pneumatic 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 a corresponding threshold may trigger the opening of the vent.

[0311] 5.3.5 Decoupling Structure In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball head and a ball socket.

[0312] 5.3.6 Connection Port Connection ports 3600, 6600, 7600, 8600, 9600, 10600, and 11600 allow connection to air loop 4170. In some examples, connection port 11600 can be integrated with positioning and stabilization structure 11300, for example... Figure 9A As shown.

[0313] Various forms of connection between air circuit 4170 and connection ports 3600, 6600, 7600, 8600, 9600, 10600, and 11600 are possible, as long as a substantially airtight seal is formed to substantially prevent pressure leakage during treatment. As described with respect to port 11600, a magnetic element may be located on the inner surface of the connection port for connection to a corresponding magnetic element on the connector located at one end of air circuit 4170. In another example, the connector of the air circuit may be attached to the connection port via a snap-fit ​​engagement (such as a ring snap-fit ​​engagement or a cantilever snap-fit ​​engagement, either of which can be rigid-to-rigid or rigid-to-elastic) or a friction engagement.

[0314] 5.3.7 Forehead Stent In one configuration, the patient interface 3000 includes a forehead support 3700.

[0315] 5.3.8 Anti-suffocation valve In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0316] Port 5.3.9 In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the pneumatic chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In another embodiment, this enables direct measurement of the properties of the gas within the pneumatic chamber 3200, such as pressure.

[0317] 5.4 RPT device An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to perform one or more algorithms 4300, such as all or part of any of the methods described herein. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0318] In one embodiment, the RPT device 4000 is configured and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0319] The RPT device may have an outer housing 4010, which is composed of two parts: an upper part 4012 and a lower part 4014. Furthermore, 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.

[0320] The pneumatic path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying positive pressure air, an outlet silencer 4124, and one or more converters 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0321] One or more air path components may be housed within a detachable, separate structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be housed within an outer casing 4010. In one embodiment, pneumatic block 4020 is supported by, or forms part of, a chassis 4016.

[0322] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a converter 4270, a data communication interface 4280, and one or more output devices 4290. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. Alternatively, the RPT device 4000 may include more than one PCBA 4202.

[0323] 5.4.1 Mechanical and pneumatic components of the RPT device The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be configured as separate units.

[0324] 5.4.1.1 Air Filter One form of RPT device according to the present technology may include one air filter 4110, or multiple air filters 4110.

[0325] In one configuration, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0326] In one configuration, an outlet air filter 4114, such as an antibacterial filter, is positioned between the pneumatic block 4020 and the patient interface 3000.

[0327] 5.4.1.2 Muffler One form of RPT device according to the present technology may include one or more mufflers 4120.

[0328] In one embodiment of this technology, the inlet silencer 4122 is disposed in the pneumatic path upstream of the pressure generator 4140.

[0329] In one embodiment of this technology, the outlet silencer 4124 is disposed in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0330] 5.4.1.3 Pressure Generator In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. When delivering respiratory pressure therapy, the blower is capable of delivering an air supply, for example, at a rate 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. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. 2013 / 020167.

[0331] The pressure generator 4140 can be controlled by the treatment device controller 4240.

[0332] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

[0333] 5.4.1.4 Converter The transducer can be located inside or outside the RPT device. An external transducer can be located on, for example, an air circuit such as a patient interface or form part of it. An external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.

[0334] In one form of this technology, one or more converters 4270 are disposed upstream and / or downstream of pressure generator 4140. The one or more converters 4270 may be configured and arranged to generate signals representing characteristics of airflow, such as flow rate, pressure, or temperature, at that point in the pneumatic path.

[0335] In one form of this technology, one or more converters 4270 may be located adjacent to the patient interface 3000.

[0336] In one embodiment, the signal from converter 4270 may be filtered, for example, by low-pass filtering, high-pass filtering, or band-pass filtering.

[0337] 5.4.1.4.1 Flow Sensor The flow sensor 4274 according to this technology can be based on a differential pressure converter, such as the SDP600 series differential pressure converter from SENSIRION.

[0338] In one configuration, a signal generated by flow sensor 4274 and representing flow rate is received by central controller 4230.

[0339] 5.4.1.4.2 Pressure Sensor The pressure sensor 4272 according to this technology is positioned in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a converter from the HONEYWELL ASDX series. An optional suitable pressure sensor is a converter from the GENERALELECTRIC NPA series.

[0340] In one configuration, the signal generated by pressure sensor 4272, which represents pressure, is received by central controller 4230.

[0341] 5.4.1.4.3 Motor Speed ​​Converter In one form of this technology, a motor speed converter 4276 is used to determine the rotational speed of motor 4144 and / or blower 4142. The motor speed signal from the motor speed converter 4276 can be provided to the treatment device controller 4240. The motor speed converter 4276 can be, for example, a speed sensor, such as a Hall effect sensor.

[0342] 5.4.1.5 Anti-overflow valve In one embodiment of this technology, an anti-backflow valve 4160 is disposed between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0343] 5.4.2 Electrical components of RPT device 5.4.2.1 Power Supply The power supply 4210 can be located inside or outside the outer casing 4010 of the RPT device 4000.

[0344] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of the invention, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.

[0345] 5.4.2.2 Input Device In one embodiment of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow personnel to interact with the device. The buttons, switches, or dials can be physical devices or software devices accessed via a touchscreen. In one embodiment, the buttons, switches, or dials can be physically connected to an external housing 4010, or in another embodiment, the buttons, switches, or dials can wirelessly communicate with a receiver electrically connected to a central controller 4230.

[0346] In one form, the input device 4220 may be configured or arranged to allow a person to select values ​​and / or menu options.

[0347] 5.4.2.3 Central Controller In one form of this technology, the central controller 4230 is one or more processors adapted to control the RPT device 4000.

[0348] Suitable processors may include x86 Intel processors, processors based on ARM® Cortex®-M processors from ARM Holdings, and microcontrollers such as the STM32 series from STMicroelectronics. In some alternative forms of this technology, a 32-bit RISC CPU such as the STR9 series microcontrollers from STMicroelectronics, or a 16-bit RISC CPU such as the MSP430 series microcontrollers from Texas Instruments, may also be applicable.

[0349] In one form of this technology, the central controller 4230 is a dedicated electronic circuit.

[0350] In one form, the central controller 4230 is an application-specific integrated circuit (ASIC). In another form, the central controller 4230 includes discrete electronic components.

[0351] The central controller 4230 can be configured to receive input signals from one or more converters 4270, one or more input devices 4220, and humidifier 5000.

[0352] The central controller 4230 can be configured to provide output signals to one or more output devices 4290, treatment device controller 4240, data communication interface 4280, and humidifier 5000.

[0353] In some forms of this technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 that can be implemented using processor control instructions, which are represented as a computer program stored in a non-transitory computer-readable storage medium such as memory 4260. In some forms of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of this technology, some methods may be performed by a remote positioning device. For example, a remote positioning device may determine the control settings of a ventilator or detect respiratory-related events by analyzing stored data from any of the sensors described herein.

[0354] 5.4.2.4 Clock RPT device 4000 may include a clock 4232 connected to central controller 4230.

[0355] 5.4.2.5 Treatment device controller In one form of this technology, the treatment device controller 4240 is a treatment control module 4330, which constitutes part of the algorithm 4300 executed by the central controller 4230.

[0356] In one embodiment of this technology, the treatment device controller 4240 is a dedicated motor control integrated circuit. For example, in one embodiment, an MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0357] 5.4.2.6 Protection Circuit One or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0358] 5.4.2.7 Memory According to one embodiment of the present technology, the RPT device 4000 includes a memory 4260, such as non-volatile memory. In some embodiments, the memory 4260 may include battery-powered static RAM. In some embodiments, the memory 4260 may include volatile RAM.

[0359] The memory 4260 can be located on PCBA 4202. The memory 4260 can be in the form of EEPROM or NAND flash memory.

[0360] Alternatively or alternatively, the RPT device 4000 includes a removable memory 4260, such as a memory card made according to the Secure Digital (SD) standard.

[0361] In one form of the present technology, memory 4260 is used as a non-transitory computer-readable storage medium storing computer program instructions representing one or more methods described herein, such as one or more algorithms 4300.

[0362] 5.4.2.8 Data Communication System In one embodiment of this technology, a data communication interface 4280 is provided and connected to a central controller 4230. The data communication interface 4280 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.

[0363] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or a processor.

[0364] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 can connect to the Internet using wired communication (e.g., via Ethernet or fiber optic) or wireless protocols (e.g., CDMA, GSM, LTE).

[0365] In one form, the local external communication network 4284 utilizes one or more communication standards, such as Bluetooth or consumer infrared protocols.

[0366] In one form, the remote external device 4286 can be one or more computers, such as a cluster of networked computers. In another form, the remote external device 4286 can be a virtual computer rather than a physical computer. In either case, this remote external device 4286 can be accessed by appropriately authorized personnel, such as clinicians.

[0367] The local external device 4288 can be a personal computer, mobile phone, tablet, or remote control device.

[0368] 5.4.2.9 Includes optional display and alarm output devices. The output device 4290 according to this technology can take the form of one or more of visual, audio, and tactile units. The visual display can be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0369] 5.4.2.9.1 Display Driver The display driver 4292 receives characters, symbols, or images as input for display on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols, or images.

[0370] 5.4.2.9 Monitor 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, in which case display driver 4292 converts each character or symbol (such as the number "0") into eight logic signals that indicate whether the eight corresponding segments will be activated to display a specific character or symbol.

[0371] 5.4.3 RPT Device Algorithm As described above, in some forms of this technology, the central controller 4230 may be configured to implement one or more algorithms 4300 represented as computer programs stored in a non-transitory computer-readable storage medium such as memory 4260. Algorithms 4300 are typically grouped into groups called modules.

[0372] In other forms of this technology, some or all of the algorithm 4300 may be implemented by the controller of an external device, such as a local external device 4288 or a remote external device 4286. In this form, data representing input signals and / or intermediate algorithm outputs required for the portion of algorithm 4300 executed at the external device may be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In this form, the portion of algorithm 4300 to be executed at the external device may be represented as a computer program stored in a non-transitory computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute that portion of algorithm 4300.

[0373] In this form, treatment parameters generated by an external device via the treatment engine module 4320 (if thus forming part of the algorithm 4300 executed by the external device) can be transmitted to the central controller 4230 to be passed to the treatment control module 4330.

[0374] 5.4.3.1 Preprocessing Module According to one form of the present technology, a preprocessing module 4310 receives a signal from a transducer 4270 (e.g., a flow sensor 4274 or a pressure sensor 4272) as input and performs one or more processing steps to calculate one or more output values ​​that will be used as input to another module (e.g., a treatment engine module 4320).

[0375] In one form of this technology, the output values ​​include interface pressure Pm, ventilation flow rate Qv, breathing flow rate Qr, and leakage flow rate Ql.

[0376] In various forms of this technology, the preprocessing module 4310 includes one or more of the following algorithms: interface pressure estimation 4312, ventilation flow estimation 4314, leakage flow estimation 4316, and breathing flow estimation 4318.

[0377] 5.4.3.1.1 Interface stress estimation In one form of this technology, the interface pressure estimation algorithm 4312 receives signals from a pressure sensor 4272 and a flow sensor 4274 as inputs, namely, the device pressure Pd and the flow rate Qd representing the airflow leaving the RPT device 4000 from the flow sensor 4274. In the absence of any supplemental gas 4180, the device flow rate Qd can be used as the total flow rate Qt. The interface pressure algorithm 4312 estimates the pressure drop P through the air circuit 4170. The dependence of the pressure drop P on the total flow rate Qt can be modeled for a specific air circuit 4170 using the pressure drop characteristic P(Q). The interface pressure estimation algorithm 4312 then provides an estimated pressure Pm as output in the patient interface 3000. The pressure Pm in the patient interface 3000 can be estimated as the device pressure Pd minus the air circuit pressure drop P.

[0378] 5.4.3.1.2 Ventilation flow rate estimation In one form of this technology, the vent flow estimation algorithm 4314 receives the estimated pressure Pm in the patient interface 3000 as input from the interface pressure estimation algorithm 4312, and estimates the air vent flow rate Qv from the vent 3400 in the patient interface 3000. For a specific vent 3400 in use, the correlation between the vent flow rate Qv and the interface pressure Pm can be simulated by the vent feature Qv(Pm).

[0379] 5.4.3.1.3 Leakage Flow Estimation In one form of this technology, the leakage flow estimation algorithm 4316 receives the total flow rate Qt and the ventilation flow rate Qv as inputs and provides an estimate of the leakage flow rate Ql as output. In another form, the leakage flow estimation algorithm estimates the leakage flow rate Ql by calculating the average of the differences between the total flow rate Qt and the ventilation flow rate Qv over a sufficiently long time period (e.g., approximately 10 seconds).

[0380] In one form, the leakage flow estimation algorithm 4316 receives the total flow rate Qt, ventilation flow rate Qv, and estimated pressure Pm from the patient interface 3000 as input, and provides the leakage flow rate Q1 as output by calculating the leakage conductivity and determining the leakage flow rate Q1 as a function of the leakage conductivity and pressure Pm. The leakage conductivity is calculated as the quotient of the low-pass filtered non-ventilation flow rate (the difference between the total flow rate Qt and the ventilation flow rate Qv) and the square root of the low-pass filtered pressure Pm, where the low-pass filtered time constant has a sufficiently long value to encompass several respiratory cycles, for example, approximately 10 seconds. The leakage flow rate Q1 can be estimated as the product of the leakage conductivity and the pressure Pm.

[0381] 5.4.3.1.4 Respiratory Flow Estimation In one form of this technology, the respiratory flow estimation algorithm 4318 receives total flow rate Qt, ventilatory flow rate Qv, and leakage flow rate Ql as inputs, and estimates the patient's air respiratory flow rate Qr by subtracting the ventilatory flow rate Qv and leakage flow rate Ql from the total flow rate Qt.

[0382] 5.4.3.2 Healing Engine Module In one form of this technology, the treatment engine module 4320 receives one or more of the pressure Pm in the patient interface 3000 and the breathing flow rate Qr of the air to the patient as input, and provides one or more treatment parameters as output.

[0383] In one form of this technique, the treatment parameter is the treatment pressure Pt.

[0384] In one form of this technique, the treatment parameters are one or more of the following: pressure variation range, baseline pressure, and target ventilation.

[0385] In various forms, the treatment engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow restriction determination 4324, apnea / insufficiency determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and treatment parameter determination 4329.

[0386] 5.4.3.2.1 Phase Determination In one form of this technology, the RPT device has an uncertain phase of 4000.

[0387] In one form of this technology, the phase determination algorithm 4321 receives a signal indicating respiratory flow Qr as input and provides the phase of the patient's current respiratory cycle. As output.

[0388] In some forms, phase output It is a discrete variable, called discrete phase determination. One implementation of discrete phase determination provides a dual-valued phase output with either the inspiratory or expiratory value at the start of spontaneous inspiration and expiration, respectively. For example, these can be represented as values ​​of 0 and 0.5 revolutions, respectively. The "trigger" and "cycle" RPT device 4000 effectively performs discrete phase determination because the trigger point and cycle point are the moments when the phase changes from expiration to inspiration and from inspiration to expiration, respectively. In one implementation of dual-value phase determination, the phase output is triggered when the respiratory flow Qr has a value exceeding a positive threshold. It is determined to have a discrete value of 0 (thus "triggering" the RPT device 4000), and the phase output is determined when the respiratory flow Qr has a value more negative than the negative threshold. It was determined to have a discrete value of 0.5 revolutions (thus “cycled” the RPT device 4000). The inspiratory time Ti and expiratory time Te can be estimated as phases. Typical values ​​over multiple respiratory cycles, equal to 0 (representing inhalation) and 0.5 (representing exhalation), respectively.

[0389] Another implementation of discrete phase determination provides a three-valued phase output with values ​​for inhalation, intermediate inspiratory pause, and exhalation. .

[0390] In other forms known as continuous phase determination, the phase output... It is a continuous variable, such as a change from 0 to 1 revolution, or from 0 to 2 radians. The RPT device 4000 performing continuous phase determination can be triggered and cycled when the continuous phase reaches 0 and 0.5 revolutions, respectively. In one implementation of continuous phase determination, fuzzy logic analysis of the respiratory flow rate Qr is used to determine the phase. The continuous values ​​of the phase determined in this implementation are often referred to as the "fuzzy phase". In one implementation of the fuzzy phase determination algorithm 4321, the following rule is applied to the respiratory flow rate Qr: 1. If the respiratory flow is zero and increases rapidly, the phase is 0 revolutions.

[0391] 2. If the respiratory flow is positive and stable, the phase is 0.25 revolutions.

[0392] 3. If the respiratory flow is zero and decreases rapidly, the phase is 0.5 revolutions.

[0393] 4. If the respiratory flow is a large negative value and stable, the phase is 0.75 revolutions.

[0394] 5. If the respiratory flow is zero and stable, and the absolute value of the 5-second low-pass filter for the respiratory flow is large, then the phase is 0.9 revolutions.

[0395] 6. If the respiratory flow is positive and the phase is expiration, then the phase is 0 revolutions.

[0396] 7. If the respiratory flow is negative and the phase is inspiration, then the phase is 0.5 revolutions.

[0397] 8. If the absolute value of the 5-second low-pass filter for respiratory flow is large, the phase increases at a steady rate equal to the patient's respiratory rate, with a 20-second time constant low-pass filter.

[0398] The output of each rule can be represented as a vector, with phase representing the result of the rule and amplitude representing the degree of ambiguity of the rule being true. The degree of ambiguity for respiratory flow such as "large" or "stable" is determined using appropriate membership functions. The results of the rules are represented as vectors and then combined using a function such as centroid. In such combinations, rules can be weighted equally or differently.

[0399] In another implementation of continuous phase determination, the phase is first estimated discretely from the respiratory flow rate Qr as described above. The same applies to inhalation time Ti and exhalation time Te. Continuous phase at any given moment. It can be determined as half of the inhalation time Ti that has elapsed since the previous trigger moment, or 0.5 revolutions plus half of the exhalation time Te that has elapsed since the previous cycle moment (whichever moment is more recent).

[0400] 5.4.3.2.2 Waveform Determination In one form of this technology, the treatment parameter determination algorithm 4329 provides an approximately constant treatment pressure throughout the patient's respiratory cycle.

[0401] In other forms of this technology, the treatment control module 4330 controls the pressure generator 4140 according to a waveform template. Provides phases as part of the patient's respiratory cycle The therapeutic pressure Pt changes as a function of the function.

[0402] In one form of this technology, waveform determination algorithm 4322 provides the phase value provided by phase determination algorithm 4321. Waveform template of values ​​in the range [0, 1] over the domain The algorithm 4329 is used to determine the treatment parameters.

[0403] In a form applicable to discrete or continuous phases, the waveform template It is a square wave template that has 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 a form suitable for continuous phase values, the waveform template... It includes two smoothly curved sections: for phase values ​​up to 0.5 revolutions, the smooth curve (e.g., raised cosine) rises from 0 to 1, while for phase values ​​greater than 0.5 revolutions, the smooth curve (e.g., exponential) decays from 1 to 0. In a form suitable for continuous phases, the waveform template... Based on square waves, but for the "rise time" during which the phase value smoothly rises from 0 to 1 until it is less than 0.5 revolutions, and for the "fall time" during which the phase value smoothly falls from 1 to 0 after 0.5 revolutions, where the "fall time" is less than 0.5 revolutions.

[0404] In some forms of this technology, the waveform determination algorithm 4322 selects a waveform template from a waveform template library according to the settings of the RPT device. Each waveform template in the library It can be provided as a relative phase value value The lookup table. In other forms, waveform determination algorithm 4322 uses a predetermined function form, possibly parameterized by one or more parameters (e.g., the time constant of the exponentially curved portion), to calculate the waveform template "in operation". The parameters of the functional form can be predetermined or depend on the current status of patient 1000.

[0405] In some forms of this technology, it is suitable for inhalation ( = 0 turns) or call out ( = 0.5 revolutions) discrete two-valued phase, waveform determination algorithm 4322 is based on the discrete phase measured from the most recent trigger time. and time t To calculate waveform templates "instantly" In one such form, waveform determination algorithm 4322 calculates the waveform template in two parts (inhalation and exhalation) as follows. :

[0406] in and It is a waveform template The inhalation and exhalation portions. In one such form, the inhalation portion of the waveform template... It is a smooth rise from 0 to 1 parameterized by the rise time, while the expiratory portion of the waveform template... It is a smooth descent from 1 to 0 parameterized by the descent time.

[0407] 5.4.3.2.3 Ventilation Measurement In one form of this technology, the ventilation determination algorithm 4323 receives input of respiratory flow Qr and determines a metric indicating the current patient ventilation Vent.

[0408] In some implementations, the ventilation determination algorithm 4323 determines a measure of the ventilation volume Vent as an estimate of the actual patient ventilation volume. One such implementation is to filter the ventilation volume using half the absolute value of the respiratory flow rate Qr (which has a second-order Bessel low-pass filter with a corner frequency of 0.11 Hz).

[0409] In other implementations, the ventilation determination algorithm 4323 determines a measure of ventilation (Vent) that is approximately proportional to the actual patient ventilation. One such implementation estimates the peak respiratory flow (Qpeak) on the inspiratory portion of the cycle. If the flow waveform shape does not vary significantly (here, the shapes of two breaths are considered similar when the flow waveforms of breaths normalized in time and amplitude are similar), then many other processes involving respiratory flow (Qr) are involved to produce measurements that are approximately proportional to ventilation. Some simple examples include the median of positive respiratory flow, the median of the absolute value of respiratory flow, and the standard deviation of the flow. Any linear combination of statistics of any order using the absolute value of respiratory flow with positive coefficients, and even some linear combinations of statistics of any order using both positive and negative coefficients, are approximately proportional to ventilation. Another example is the average of the respiratory flow at the median K proportion (over time) of the inspiratory portion, where 0 < K < 1. If the flow shape is constant, then there are any number of measurements that are precisely proportional to ventilation.

[0410] 5.4.3.2.4 Determine the inspiratory flow rate limit In one embodiment of this technology, the central controller 4230 executes an inspiratory flow rate limitation determination algorithm 4324 to determine the degree of inspiratory flow rate limitation.

[0411] In one form, the inspiratory flow limitation determination algorithm 4324 receives the respiratory flow signal Qr as input and provides a measure of the degree to which the inspiratory portion of the breath exhibits inspiratory flow limitation as output.

[0412] In one form of this technique, the inspiratory portion of each breath is identified by a zero-crossing detector. Multiple evenly spaced points (e.g., 65) representing time points are interpolated along the inspiratory flow-time curve for each breath by an interpolator. The curve described by these points is then scalar-scaled to have a uniform length (duration / cycle) and a uniform area to eliminate the effects of variations in respiratory rate and depth. The scaled breath is then compared in a comparator to a pre-stored template representing normal unobstructed breathing, similar to... Figure 6The breathing shown represents the inspiratory portion of the breath. At any time during the inspiratory period from this template, breaths deviating beyond a specified threshold (typically 1 scaling unit) are rejected, such as those caused by coughing, sighing, swallowing, and hiccups as determined by the test element. For non-rejected data, the central controller 4230 calculates a moving average of the first such scaling point of the preceding few inspiratory events. For the second such point, this is repeated on the same inspiratory event, and so on. Thus, for example, 65 scaling data points are generated by the central controller 4230 and represent the moving average of the preceding few inspiratory events (e.g., three events). The moving average of the continuously updated values ​​of the sixty-five points is referred to below as the “scaling flow”, denoted as... Qs(t) Alternatively, a single inspiratory event can be used instead of a moving average.

[0413] Based on the scaled flow rate, two shape factors can be calculated to determine the partial blockage.

[0414] The shape factor 1 is the ratio of the average of intermediate (e.g., 32) scaled flow points to the total average (e.g., 65) scaled flow points. A ratio greater than 1 indicates normal breathing. A ratio of 1 unit or less indicates obstructed breathing. A ratio of approximately 1.17 is used as the threshold between partially obstructed and unobstructed breathing, and is equal to the degree of obstruction that allows for adequate oxygenation in a typical patient.

[0415] The shape factor 2 is calculated as the RMS deviation per unit scaled flow rate at the midpoint (e.g., 32). An RMS deviation of approximately 0.2 units is considered normal. Zero RMS deviation is considered fully flow-limited breathing. The closer the RMS deviation is to zero, the more airflow is restricted during breathing.

[0416] Shape factors 1 and 2 can be used interchangeably or in combination. In other forms of this technique, the number of sampling points, breaths, and intermediate points can differ from those described above. Furthermore, the threshold can differ from the threshold described.

[0417] 5.4.3.2.5 Measurement of Apnea and Insufficiency In one form of this technology, the central controller 4230 executes an apnea / hypoventricular dysfunction determination algorithm 4325 to determine the presence of apnea and / or hypoventricular dysfunction.

[0418] In one form, the apnea / insufficiency determination algorithm 4325 receives the respiratory flow signal Qr as input and provides a flag indicating that apnea or insufficiency has been detected as output.

[0419] In one form, apnea is considered detected when a function of respiratory flow Qr falls below a flow threshold within a predetermined time period. This function can determine peak flow, relatively short-term average flow, or an intermediate flow between relatively short-term average and peak flow, such as RMS flow. The flow threshold can be a relatively long-term measure of flow.

[0420] In one form, insufficiency is considered detected when a function of respiratory flow Qr falls below a second flow threshold within a predetermined time period. This function can determine peak flow, a relatively short-term average flow, or an intermediate flow between a relatively short-term average and peak flow, such as RMS flow. The second flow threshold can be a relatively long-term flow measurement. The second flow threshold is greater than the flow threshold used to detect apnea.

[0421] 5.4.3.2.6 Measurement of snoring In one form of this technology, the central controller 4230 executes one or more snoring determination algorithms 4326 for determining the degree of snoring.

[0422] In one form, the snoring determination algorithm 4326 receives the respiratory flow signal Qr as input and provides a measure of the degree of snoring as output.

[0423] The snoring determination algorithm 4326 may include the step of determining the intensity of the flow signal in the range of 30-300 Hz. Furthermore, the snoring determination algorithm 4326 may include the step of filtering the respiratory flow signal Qr to reduce background noise (e.g., airflow noise from a blower system).

[0424] 5.4.3.2.7 Determination of airway patency In one form of this technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 to determine the degree of airway patency.

[0425] In one form, the airway patency determination algorithm 4327 receives the respiratory flow signal Qr as input and determines the power of the signal in a frequency range of approximately 0.75 Hz and approximately 3 Hz. A peak in this frequency range indicates an open airway. The absence of a peak is considered an indication of a closed airway.

[0426] In one form, the frequency range for seeking the peak is the frequency of a small forced oscillation in the therapeutic pressure Pt. In one implementation, the forced oscillation frequency is 2 Hz and the amplitude is approximately 1 cmH2O.

[0427] In one form, the airway patency determination algorithm 4327 receives the respiratory flow signal Qr as input and determines whether a cardiac signal is present. The absence of a cardiac signal is considered an indication of a closed airway.

[0428] 5.4.3.2.8 Determination of target ventilation rate In one form of this technology, the central controller 4230 takes the measured value of the current ventilation volume Vent as input and executes one or more target ventilation volume determination algorithms 4328 to determine a target value Vtgt of the ventilation volume measurement.

[0429] In some forms of this technology, there is no target ventilation determination algorithm 4328, and the target value Vtgt is predetermined, for example, by hard coding during the configuration of the RPT device 4000 or by manual input via the input device 4220.

[0430] In other forms of this technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates the target value Vtgt from a value Vtyp that indicates the patient's typical recent ventilation.

[0431] In some forms of adaptive servo ventilation, the target ventilation volume Vtgt is calculated as a high proportion of the typical recent ventilation volume Vtyp, but less than the typical recent ventilation volume Vtyp. This high proportion in these forms can be in the range of (80%, 100%), (85%, 95%), or (87%, 92%).

[0432] In other forms of adaptive servo ventilation, the target ventilation volume Vtgt is calculated as an integer multiple slightly larger than the typical recent ventilation volume Vtyp.

[0433] A typical recent ventilation volume, Vtyp, is a value around which the distribution of current ventilation volume (Vent) measurements at multiple moments on a predetermined time scale tends to cluster; that is, it is a measure of the central tendency of the current ventilation volume measurement in recent history. In one implementation of the target ventilation volume determination algorithm 4328, the most recent historical record is on the order of several minutes, but should in any case be longer than the time range of the Cheyne-Stokes breathing growth and decay cycles. The target ventilation volume determination algorithm 4328 can use any of the various known measures of central tendency to determine the typical recent ventilation volume Vtyp based on the current ventilation volume (Vent) measurement. One such measurement is the output of a low-pass filter on the measurement of the current ventilation outlet, where the time constant is equal to one hundred seconds.

[0434] 5.4.3.2.9 Determination of Treatment Parameters In some forms of this 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 other algorithms in the treatment engine module 4320.

[0435] In one form of this technique, the treatment parameter is the instantaneous treatment pressure Pt. In one implementation of this form, the treatment parameter determination algorithm 4329 uses the following equation to determine the treatment pressure Pt.

[0436] in: A is the amplitude. It is the phase of time and the current value of t. The waveform template value (in the range of 0 to 1), and P0 is the base pressure.

[0437] If waveform determination algorithm 4322 provides a waveform template As a result of phase index value If the lookup table is correct, then the treatment parameter determination algorithm 4329 locates the nearest lookup table entry to the current phase value returned by the phase determination algorithm 4321. Or by crossing the current phase value Interpolation is performed between the two entries to apply equation (1).

[0438] The values ​​of amplitude A and baseline pressure P0 can be determined by treatment parameter algorithm 4329 and set in the following manner according to the selected respiratory pressure treatment mode.

[0439] 5.4.3.3 Treatment Control Module According to one aspect of the present technology, the treatment control module 4330 receives treatment parameters from the treatment parameter determination algorithm 4329 of the treatment engine module 4320 as input, and controls the pressure generator 4140 to deliver airflow according to the treatment parameters.

[0440] In one form of this technology, the treatment parameter is the treatment pressure Pt, and the treatment control module 4330 controls the pressure generator 4140 to deliver an airflow at an interface pressure Pm at the patient interface 3000 equal to the treatment pressure Pt.

[0441] 5.4.3.4 Fault Status Detection In one form of this technology, the central controller 4230 executes one or more methods 4340 for detecting fault conditions. The fault conditions detected by the one or more methods 4340 may include at least one of the following: Power failure (no power or insufficient power). Converter fault detection Unable to detect the existence of the component Operating parameters are outside the recommended range (e.g., pressure, flow rate, temperature, PaO2).

[0442] The test alarm failed to generate a detectable alarm signal.

[0443] When a fault condition is detected, the corresponding algorithm 4340 notifies the existence of the fault by signaling one or more of the following: Activate auditory, visual, and / or dynamic (e.g., vibration) alarms. Send messages to external devices Event Log 5.5 Air Circuit According to one aspect of the present technology, the air circuit 4170 is a conduit or tube that is constructed and arranged in use to allow airflow between two components such as the RPT device 4000 and the patient interface 3000.

[0444] Specifically, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, it may have separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.

[0445] 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 raise the temperature of the air. The heating elements may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating elements may be communicated with a controller, such as a central controller 4230. An embodiment of an air circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0446] 5.5.1 Auxiliary Gas Delivery In one form of the technology, supplemental gas (e.g., oxygen) 4180 is delivered to one or more points in the pneumatic path, such as upstream of pneumatic block 4020, to air circuit 4170, and / or to patient interface 3000 or 3800.

[0447] 5.6 Humidifier 5.6.1 Humidifier Overview In one form of this technology, a humidifier 5000 is provided (e.g., as in...). Figure 11A (As shown) to change the absolute humidity of the air or gas delivered to the patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0448] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering the humidified airflow. In some forms, such as Figure 11A and 11B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which is adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.

[0449] 5.6.2 Humidifier Components 5.6.2.1 Water Storage Tank According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to maintain or retain a liquid (e.g., water) capacity for evaporation to humidify the airflow. The water reservoir 5110 may be configured to maintain a predetermined maximum water capacity to provide adequate humidification for at least the duration of a respiratory treatment, such as an overnight sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 ml, 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply system.

[0450] According to one aspect, the water reservoir 5110 is configured to humidify the airflow from the RPT device 4000 when an airflow passes through it. In one form, the water reservoir 5110 may be configured to facilitate the airflow in a curved path through the reservoir 5110 when in contact with the water volume therein.

[0451] According to one form, the storage 5110 can, for example, be along such a path. Figure 11A and Figure 11B Remove from humidifier 5000 in the lateral direction shown.

[0452] The reservoir 5110 may also be configured to prevent liquid from flowing out through any orifice and / or from its sub-assemblies when the reservoir 5110 is displaced and / or rotated from its normal operating direction. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent loss of pneumatic pressure through leakage and / or flow resistance.

[0453] 5.6.2.2 Conductive Component According to one arrangement, the reservoir 5110 includes a vent 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume within the reservoir 5110. In one form, the vent 5120 may be arranged as a plate, but other shapes are equally applicable. All or part of the vent 5120 may be made of a thermally conductive material, such as aluminum (e.g., with a thickness of about 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity may be achieved using materials with appropriate geometries and lower thermal conductivity.

[0454] 5.6.2.3 Humidifier reservoir dock In one embodiment, the humidifier 5000 may include a humidifier reservoir base 5130 (e.g., Figure 11B As shown, it is configured to receive a humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include a locking mechanism, such as a locking lever 5135 configured to hold the reservoir 5110 in the humidifier reservoir base 5130.

[0455] 5.6.2.4 Water level indicator Humidifier reservoir 5110 may include, for example Figure 11A-11B The water level indicator 5150 is shown. In some forms, the water level indicator 5150 may provide a user (such as a patient 1000 or a caregiver) with one or more indications regarding the amount of water in the humidifier reservoir 5110. One or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined capacity of water, any portion thereof, such as 25%, 50%, 75%, or a capacity such as 200 ml, 300 ml, or 400 ml.

[0456] 5.6.2.5 Humidifier Converter The humidifier 5000 may include one or more humidifier converters (sensors) 5210, alternative to or in addition to the converter 4270 described above. The humidifier sensor 5210 may include one or more air pressure sensors 5212, air flow sensors 5214, temperature sensors 5216, or humidity sensors 5218, such as... Figure 11CAs shown. The humidifier converter 5210 can generate one or more output signals that can be sent to a controller (such as a central controller 4230 and / or a humidifier controller 5250). In some forms, the humidifier converter can be located outside the humidifier 5000 (such as in the air circuit 4170) when sending the output signal to the controller.

[0457] 5.6.2.5.1 Pressure Transmitter In addition to the pressure sensor 4272 provided in the RPT device 4000, the humidifier 5000 may be provided with one or more pressure transducers 5212.

[0458] 5.6.2.5.2 Flow Converter In addition to the flow sensor 4274 provided in the RPT device 4000, the humidifier 5000 may be provided with one or more flow converters 5214.

[0459] 5.6.2.5.3 Temperature Converter The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures, such as the temperature of the heating element 5240 and / or the temperature of the airflow downstream of the humidifier outlet 5004. In some forms, the humidifier 5000 may also include a temperature sensor 5216 for detecting the ambient air temperature.

[0460] 5.6.2.5.4 Humidity Converter In some forms, the humidifier 5000 may include one or more humidity sensors 5218 for detecting the humidity of a gas, such as ambient air. In some forms, the humidity sensor 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.

[0461] 5.6.2.6 Heating element In some cases, heating element 5240 may be provided to humidifier 5000 to provide heat input to one or more of the water capacity in humidifier reservoir 5110 and / or to airflow. Heating element 5240 may include heat-generating components, such as resistive electric heating rails. A suitable example of heating element 5240 is a layered heating element, such as the layered heating element described in PCT patent application publication number WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0462] In some forms, the heating element 5240 may be provided in the humidifier base 5006, wherein, for example Figure 11BThe heat shown can be supplied to the humidifier reservoir 5110 primarily through conduction.

[0463] 5.6.2.7 Humidifier Controller According to one arrangement of the present technology, the humidifier 5000 may include, for example: Figure 11C The humidifier controller 5250 is shown. In one embodiment, the humidifier controller 5250 may be part of the central controller 4230. In another embodiment, the humidifier controller 5250 may be a standalone controller that can communicate with the central controller 4230.

[0464] In one embodiment, the humidifier controller 5250 may receive, for example, measurements of airflow and water properties (such as temperature, humidity, pressure, and / or flow rate) in the reservoir 5110 and / or humidifier 5000 as inputs. The humidifier controller 5250 may also be configured to execute or implement humidifier algorithms and / or deliver one or more output signals.

[0465] like Figure 11C As shown, 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.

[0466] 5.7 Screening, Diagnosis, and Monitoring System 5.7.1 Overview At least some forms of this technology allow for the use of sensors integrated into a patient interface to screen, diagnose, and / or monitor sleep health. The sensors can be positioned within the positioning and stabilization structures of the patient interface, such as... Figure 9A and 9B The positioning and stabilization structure 11300, and / or located in the pneumatic chamber of the patient interface.

[0467] For example, as described above, a headband-type sensor positioning and stabilization structure, such as the Positioning and Stabilization Structure 6300 or 11300, can be worn by the patient as a headband before the start of treatment, and sensor measurements can be recorded during sleep. Sensor measurements can be used to precisely monitor sleep stages and sleep positions, track vital signs and other physiological indicators, and detect apnea and / or hypopnea events. Clinicians can use the sleep and physiological data to diagnose sleep disorders and recommend appropriate treatment. Furthermore, the same parameters can be monitored by the sensors during treatment and compared with parameters before the start of treatment (or at an earlier stage of treatment) to allow patients and clinicians to assess the effectiveness of the treatment.

[0468] As described above, physiological and sleep data can be recorded by one or more sensors on the patient interface and transmitted to external computing devices, such as the patient's smartphone, and / or to a monitoring server operated or accessible by a clinician or other healthcare provider.

[0469] In some forms of this technology, a pulse oximeter integrated into the positioning and stabilization structure 11300 can be used to determine blood oxygen saturation levels and heart rate during patient wearing of the patient interface 11000, and this data can be transmitted to an external computing device, such as a smartphone, other mobile computing device, or the patient's on-lap or desktop computing system. The data may include time-series data, which can be combined to provide the patient with feedback on their health level and, for example, recommendations for follow-up (e.g., by a clinician). For example, this can be based on the determination of AHI as described above, which can be used in conjunction with other sensor measurements to determine when and how frequently apnea events occur. This data can also be used to design optimal treatment plans for the patient.

[0470] Other sensors that can be incorporated into a screening, diagnostic, and / or monitoring system that includes a sensor-enabled patient interface include, but are not limited to: an EEG sensor for detecting sleep stages; EMG and EOG sensors for determining REM sleep stage events; a microphone for detecting snoring or other sounds that indicate disturbed sleep; and humidity, temperature, pressure, and / or CO2 sensors, all located within the pneumatic chamber 11200 of the patient interface.

[0471] The following describes some example applications of the sensor-enabled patient interface.

[0472] 5.7.2 Polysomnography Polysomnography (PSG) is a monitoring procedure that typically involves a variety of different sensors and associated devices, and can be challenging to install even for experts. A typical PSG system includes a pressure head box that receives and records signals from the following sensors: EOG electrodes; EEG electrodes; ECG electrodes; submedial EMG electrodes; snoring sensors; respiratory inductance plethysmography (respiratory effort sensors) on a chest strap; respiratory inductance plethysmography (respiratory effort sensors) on an abdominal strap; a cannula with an oral thermistor; photoplethysmography (pulse oximeter); and a body position sensor. The electrical signal is referred to as the grounded electrode (ISOG) located at the center of the forehead.

[0473] A sensor-enabled patient interface, such as patient interface 11000, can replace some or all of the functions of an existing PSG system because, as described above, some or all of the sensors used in the PSG system can be housed in the positioning and stabilization structure (e.g., 11300) and / or the pneumatic chamber (e.g., 11200). For example, EOG, EEG, ECG, and EMG electrodes, a microphone (used as a snoring sensor), a PPG sensor, and an accelerometer and / or gyroscope (used as a body position sensor) can be housed in the upper fabric portion 11310 and / or the lower fabric portions 11308, 11320 of the positioning and stabilization structure 11300. A grounding electrode (e.g., in the lower fabric portion 11308, for placement behind the patient's ear, as described above) can also be provided.

[0474] By integrating the sensor with the patient interface 11000, PSG becomes more straightforward in at least some examples, as patients can simply wear the patient interface 11000 in the manner they would use it for treatment, without requiring or requiring minimal additional configuration (e.g., no need to manually place the various electrodes for the EEG / EMG / EOG sensor).

[0475] 5.7.3 Non-intrusive monitoring system 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 stabilization structure 11300. The motion sensors are configured to generate one or more signals representing the patient's body movements, from which signals representing the patient's respiratory movements can be obtained.

[0476] 5.7.4 Polysomnography Polysomnography (RPG) is a simplified form of PSG without electrical signals (EOG, EEG, EMG), snoring, or body position sensors. Typically, RPG includes at least chest motion signals from a respiratory-sensing plethysmography (motion sensor) on a chest strap, nasal pressure signals sensed via a nasal cannula, and oxygen saturation signals from a pulse oximeter (e.g., a pulse oximeter). These three RPG signals or channels are received by an RPG pressure head chamber.

[0477] A sensor-enabled patient interface, such as patient interface 11000, can replace some or all of the functions of an existing RPG system. For example, accelerometer and / or gyroscope measurements from sensors mounted in headband 11300 can be used as proxies for chest motion signals. Nasal pressure signals can be measured by pressure sensors mounted in the pneumatic chamber, for example, mounted on the inner surface of the pneumatic chamber so that they are located near the patient's nostrils during use. Oxygen saturation signals can be measured by PPG sensors mounted in headband 11300, such as... Figure 9CAs shown in 11355, the agent chest movement signal, nasal pressure signal, and oxygen saturation signal can be received by the on-board processor 11350 of the patient interface 11000, and / or can be transmitted to an external computing device for analysis in the same manner as conventional RPG signals.

[0478] In some configurations, the nasal pressure signal is a satisfactory representative of the nasal flow signal generated by a flow sensor aligned with the sealed nasal mask, as the nasal pressure signal is similar in shape to the nasal flow signal. If the patient's mouth remains closed, i.e., there is no mouth leakage, then the nasal flow is equal to the respiratory flow.

[0479] 5.8 Portable Oxygen Concentrator (POC) Portable oxygen concentrators can utilize pressure swing adsorption (PSA). PSA can involve using one or more compressors to increase the gas pressure within a canister containing gas-separating adsorbent particles arranged in a “sieve bed.” As the pressure increases, some molecules in the gas may be adsorbed onto the gas-separating adsorbent. Removing a portion of the gas from the canister under pressurized conditions allows non-adsorbed molecules to separate from the adsorbed molecules. The gas-separating adsorbent can be regenerated by reducing the pressure, which reverses the molecular adsorption from the adsorbent. Further details regarding oxygen concentrators can be found, for example, in U.S. Patent Application Publication No. 2009-0065007, entitled “Oxygen Concentrator Apparatus and Method,” published March 12, 2009, which is incorporated herein by reference.

[0480] Ambient air typically comprises approximately 78% nitrogen and 21% oxygen, with the remainder consisting of argon, carbon dioxide, water vapor, and other trace gases. If a gas mixture, such as air, is passed under pressure through a canister containing a bed of gas-separating adsorbent, which attracts nitrogen more strongly than oxygen, some or all of the nitrogen will remain in the bed, and the gas exiting the canister will be oxygen-rich. When the bed's ability to adsorb nitrogen ends, it can be regenerated by reducing the pressure, thereby releasing the adsorbed nitrogen. This prepares the canisters for another cycle of producing oxygen-enriched air. By alternating canisters in a dual-canister system, one canister can separate oxygen while the other is purified (resulting in continuous separation of oxygen and nitrogen). In this way, oxygen-enriched air can be accumulated, such as in storage containers or other pressurized containers or conduits connected to the canisters, for a variety of uses, including providing supplemental oxygen to patients.

[0481] 5.9 Breathing Therapy Mode Various respiratory therapy modes can be achieved through the disclosed respiratory therapy system.

[0482] 5.9.1 CPAP Therapy In some implementations of respiratory pressure therapy, the central controller 4230 sets the treatment pressure Pt according to a treatment pressure equation as part of the treatment parameter determination algorithm 4329. In one such implementation, the amplitude A is also zero, so the treatment pressure Pt (which represents the target value achieved by the interface pressure Pm at the current moment) is also equal to the baseline pressure P0 throughout the respiratory cycle. Such implementations are typically grouped under the heading of CPAP therapy. In such implementations, the treatment engine module 4320 does not need to determine the phase. or waveform template .

[0483] In CPAP therapy, the basal pressure P0 can be a constant value, either hard-coded or manually input into the RPT device 4000. Alternatively, the central controller 4230 can repeatedly calculate the basal pressure P0 as a function of indicators or measures of sleep-disordered breathing returned by a corresponding algorithm in the therapy engine module 4320, such as flow restriction, apnea, hypopnea, patency, and snoring, or more of these indicators or measures. This type of selection is sometimes referred to as APAP therapy.

[0484] Figure 10E The diagram illustrates a flowchart of method 4500 executed by the central controller 4230, which continuously calculates the basal pressure P0 as part of the APAP treatment implementation of the treatment parameter determination algorithm 4329 when the pressure support A equals zero.

[0485] Method 4500 begins at step 4520, where the central controller 4230 compares a measurement of the presence of apnea / insufficiency with a first threshold and determines whether the measurement has exceeded the first threshold for a predetermined time period, thereby indicating that apnea / insufficiency is occurring. If so, method 4500 proceeds to step 4540; otherwise, method 4500 proceeds to step 4530. In step 4540, the central controller 4230 compares a measurement of airway patency with a second threshold. If the airway patency measurement exceeds the second threshold, indicating that the airway is patent, the detected apnea / insufficiency is considered central, and method 4500 proceeds to step 4560; otherwise, the apnea / insufficiency is considered obstructive, and method 4500 proceeds to step 4550.

[0486] In step 4530, the central controller 4230 compares the measured value of the flow restriction with a third threshold. If the measurement of the flow restriction exceeds the third threshold, indicating that the inspiratory flow is restricted, then method 4500 proceeds to step 4550; otherwise, method 4500 proceeds to step 4560.

[0487] In step 4550, the central controller 4230 increases the base pressure P0 by a predetermined pressure increment P, provided that the resulting treatment pressure Pt does not exceed the maximum treatment pressure P. max In one implementation, the predetermined pressure increment P and the maximum therapeutic pressure P max These are 1 cmH2O and 25 cmH2O, respectively. In other implementations, the pressure increment P can be as low as 0.1 cmH2O and as high as 3 cmH2O, or as low as 0.5 cmH2O and as high as 2 cmH2O. In other implementations, the maximum therapeutic pressure P... max The range can be as low as 15 cmH2O and as high as 35 cmH2O, or as low as 20 cmH2O and as high as 30 cmH2O. Method 4500 then returns to step 4520.

[0488] In step 4560, the central controller 4230 reduces the baseline pressure P0 by a certain amount, provided that the reduced baseline pressure P0 does not fall below the minimum treatment pressure Pmin. Method 4500 then returns to step 4520. In one implementation, the reduction amount is proportional to the value of P0-pmin, such that the reduction of P0 to the minimum treatment pressure Pmin is exponential in the absence of any detected event. In one implementation, the proportionality constant is set such that the time constant for the exponential reduction of P0 is 60 minutes, and the minimum treatment pressure Pmin is 4 cmH2O. In other implementations, the time constant can be as low as 1 minute and as high as 300 minutes, or as low as 5 minutes and as high as 180 minutes. In other implementations, the minimum treatment pressure Pmin can be as low as 0 cmH2O and as high as 8 cmH2O, or as low as 2 cmH2O and as high as 6 cmH2O. Alternatively, the reduction of P0 can be predetermined, so that the reduction of P0 to the minimum treatment pressure Pmin is linear in the absence of any detected event.

[0489] 5.9.2 Bilevel therapy In other implementations of this form of the technique, the value of amplitude A in equation (1) can be positive. Such an implementation is called bilevel therapy because, when determining the treatment pressure Pt using equation (1) with a positive amplitude A, the treatment parameter determination algorithm 4329 oscillates the treatment pressure Pt between two values ​​or levels in sync with the patient's spontaneous respiratory effort. That is, based on the aforementioned typical waveform template. The treatment parameter determination algorithm 4329 increases the treatment pressure Pt to P0+A (called IPAP) at the beginning or during the inhalation or exhalation, and decreases the treatment pressure Pt to the baseline pressure P0 (called EPAP) at the beginning or during the exhalation.

[0490] In some forms of bilevel therapy, IPAP is the therapeutic pressure with the same purpose as the therapeutic pressure in CPAP therapy mode, while EPAP is IPAP minus amplitude A, which has a "small" value (a few cmH2O), sometimes referred to as expiratory pressure release (EPR). This type of therapy is sometimes referred to as CPAP therapy using EPR, and it is generally considered more comfortable than direct CPAP therapy. In CPAP therapy using EPR, both IPAP and EPAP can be constant values ​​hard-coded or manually entered into the RPT device 4000. Alternatively, the treatment parameter determination algorithm 4329 can repeatedly calculate IPAP and / or EPAP during CPAP with EPR. In this alternative, the treatment parameter determination algorithm 4329 repeatedly calculates EPAP and / or IPAP in a manner similar to the calculation of the basal pressure P0 in APAP therapy described above, as a function of an indicator or measure of sleep apnea returned by the corresponding algorithm in the treatment engine module 4320.

[0491] In other forms of bilevel therapy, the amplitude A is large enough that the RPT device 4000 performs some or all of the patient's work of breathing (1000). In this type of therapy, known as pressure support ventilation, the amplitude A is referred to as pressure support or oscillation. In pressure support ventilation, IPAP is the baseline pressure P0 plus pressure support A, and EPAP is the baseline pressure P0.

[0492] In some forms of pressure support therapy, known as fixed pressure support therapy, pressure support A is fixed at a predetermined value, such as 10 cmH2O. The predetermined pressure support value is the setting of the RPT device 4000 and can be set, for example, by hard decoding during the configuration of the RPT device 4000 or by manual input via the input device 4220.

[0493] In other forms of pressure support ventilation therapy, widely referred to as servo ventilation, the treatment parameter determination algorithm 4329 takes some currently measured or estimated parameters of the respiratory cycle (e.g., the current measurement of ventilation, Vent) and the target value of that respiratory parameter (e.g., the target value of ventilation, Vtgt) as input, and repeatedly adjusts the parameters of equation (1) to steer the current measurement of the respiratory parameter toward the target value. In a form of servo ventilation known as adaptive servo ventilation (ASV), which has been used to treat CSR, the respiratory parameter is the tidal volume, and the target tidal volume value Vtgt is calculated by the target tidal volume determination algorithm 4328 from the typical recent tidal volume Vtyp, as described above.

[0494] In some forms of servo ventilation, the treatment parameter determination algorithm 4329 applies a control method to repeatedly calculate the pressure support A so as to orient the current measurement of the respiratory parameters toward the target value. One such control method is proportional-integral (PI) control. In one implementation of PI control, suitable for an ASV mode where the target tidal volume Vtgt is set slightly less than the typical recent tidal volume Vtyp, the pressure support A is repeatedly calculated as:

[0495] Here, G is the gain controlled by PI. A larger gain G value can lead to positive feedback in the treatment engine module 4320. A smaller gain G value can allow some residual untreated CSR or central sleep apnea. In some implementations, the gain G is fixed at a predetermined value, such as -0.4 cmH2O / (L / min) / sec. Alternatively, the gain G can be varied between treatment sessions, decreasing at the beginning of one session and increasing from one session to another until a value is reached that substantially eliminates the CSR. In such implementations, conventional methods for retrospectively analyzing parameters of treatment sessions to assess the severity of CSR during the treatment session can be employed. In other implementations, the gain G can be varied based on the difference between the current measurement of ventilation (Vent) and the target ventilation (Vtgt).

[0496] Other servo ventilation control methods that can be applied by the treatment parameters include proportional (P), proportional-derivative (PD), and proportional-integral-derivative (PID).

[0497] The pressure support value A calculated via Equation 2 can be limited to a range defined as [Amin, Amax]. In this implementation, pressure support A is at the minimum pressure support Amin by default until the measured value of the current ventilation volume Vent drops below the target ventilation volume Vtgt, at which point A begins to increase and only decreases back to Amin when Vent exceeds Vtgt again.

[0498] The pressure support limits Amin and Amax are settings of the RPT device 4000, for example, by hard coding during the configuration of the RPT device 4000 or by manual input via the input device 4220.

[0499] In pressure support ventilation therapy, EPAP is the baseline pressure P0. Similar to the baseline pressure P0 in CPAP therapy, EPAP can be a constant value specified or determined during titration. Such a constant EPAP can be set, for example, through hard coding during RPT device 4000 configuration or through manual input via input device 4220. This alternative is sometimes referred to as fixed-EPAP pressure support ventilation therapy. Patient EPAP titration can be performed by the clinician during titration using a PSG to prevent obstructive apnea, thereby maintaining an open airway for pressure support ventilation therapy in a manner similar to the titration of baseline pressure P0 in constant CPAP therapy.

[0500] Alternatively, the treatment parameter determination algorithm 4329 can repeatedly calculate the basal pressure P0 during pressure support ventilation therapy. In such an implementation, the treatment parameter determination algorithm 4329 repeatedly calculates EPAP as a function of an index or metric of sleep-disordered breathing returned by the corresponding algorithm in the treatment engine module 4320, such as flow restriction, apnea, hypopnea, patency, and snoring, or one or more of these. Because the continuous calculation of EPAP is similar to the manual adjustment of EPAP by a clinician during EPAP titration, this process is sometimes referred to as automatic EPAP titration, and the treatment mode is referred to as automatic titration EPAP pressure support ventilation therapy or automatic EPAP pressure support ventilation therapy.

[0501] 5.10 Glossary For the purposes of this disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0502] 5.10.1 Overview Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-enriched air.

[0503] Environment: In some forms of this technology, the term environment may have the following meanings: (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0504] For example, the ambient humidity relative to the humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity in the patient's sleeping room. This type of ambient humidity can differ from the humidity outside the patient's sleeping room.

[0505] In another example, environmental stress can be stress that is directly around the body or outside the body.

[0506] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room, excluding noise generated by, for example, the RPT device or from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0507] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between minimum and maximum, for example from breathing to exhalation, depending on the presence or absence of an SDB event.

[0508] Continuous positive airway pressure (CPAP) therapy: In this therapy, the treatment pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in response to the absence of such an indication.

[0509] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be a scalar quantity, i.e., a quantity that has only magnitude. In other cases, the reference to flow rate will be a vector quantity, i.e., a quantity that has both magnitude and direction. Flow rate can be given the symbol Q. "Flow rate" is sometimes shortened to simply "flow" or "airflow".

[0510] In the example of patient breathing, the flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Device flow rate Qd is the air flow rate leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. Ventilation flow rate Qv is the air flow rate leaving the vent to allow flushing of exhaled gas. Leakage flow rate Ql is the leakage flow rate from the patient interface system or elsewhere. Respiratory flow rate (Qr) is the air flow rate received into the patient's respiratory system.

[0511] Flow therapy: Breathing therapy involves delivering a flow of air to the airway inlet at a controlled flow rate known as the therapeutic flow rate, which is generally positive throughout the patient’s respiratory cycle.

[0512] Humidifier: The term humidifier will be understood as a humidification device that is constructed and arranged, or has a physical structure, to provide a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve a patient’s medical respiratory condition.

[0513] Leakage: The term "leakage" will be understood as undesirable airflow. In one example, a leak could occur due to an incomplete seal between the mask and the patient's face. In another example, a leak could occur in a bend in the conduit leading to the surrounding environment.

[0514] Noise, conducted (acoustic): In this document, conducted noise refers to noise delivered to the patient through pneumatic pathways, such as air circuits and patient interfaces, 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.

[0515] Noise, radiated (acoustic): Radiated noise in this document refers to noise transmitted to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object under discussion according to ISO 3744.

[0516] Noise, ventilation (acoustic): Ventilation noise in this document refers to the noise generated by the flow of air through any ventilation opening, such as the ventilation port of the patient interface.

[0517] Oxygen-enriched air: Air with an oxygen concentration greater than that of atmospheric air (21%), such as at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. “Oxygen-enriched air” is sometimes simply referred to as “oxygen”.

[0518] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0519] Patient: A person, whether or not they have a respiratory illness.

[0520] Pressure: Force per unit area. Pressure can be expressed in units, including cmH2O and gf / cm². 2 And hectopascal (hectopascal). 1 cmH2O equals 1 gf / cm³ 2 And approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m) 2 =1 mbar to 0.001 atm). In this specification, unless otherwise stated, pressure is given in cmH2O.

[0521] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained through the interface pressure Pm at the current moment.

[0522] Respiratory pressure therapy (RPT): Applying an air supply to the airway inlet at a therapeutic pressure that is typically positive relative to the atmosphere.

[0523] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of their breathing.

[0524] 5.10.1.1 Materials Silicone or silicone elastomer: Synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0525] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0526] Fabric: A flexible material formed from a web of fibers, which may be natural, man-made, or a combination thereof. Fibers (e.g., wool, flax, cotton, hemp, and / or synthetic fibers) may be spun into yarns, which may be woven, knitted, crocheted, knotted, woven, felted, and / or braided to form a fabric. As used herein, the terms “fabric” and “woven fabric” are used interchangeably.

[0527] 5.10.1.2 Mechanical Properties Elasticity: The ability of a material to absorb energy when it undergoes elastic deformation and to release energy when it is unloaded.

[0528] Resilient: When decelerated, it releases virtually all of its energy. This includes, for example, certain silicones and thermoplastic elastomers.

[0529] Hardness: The ability of a material to resist deformation (e.g., described by Young's modulus or an indentation hardness scale measured on a standardized sample size).

[0530] "Soft" materials can include silicone resins or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0531] "Hard" materials can include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0532] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. The structure or component can provide different resistance in different directions. The reciprocal of stiffness is flexibility.

[0533] Soft structures or components: Structures or components that will change shape (e.g., bend) within a relatively short period of time (such as 1 second) when made to support their own weight.

[0534] Rigid structures or components: Structures or components that do not substantially change shape when subjected to loads typically encountered in use. An example of such use could be setting up and maintaining a patient interface in a sealed relationship with the inlet of the patient's airway, for example, under a load of approximately 20 to 30 cmH2O.

[0535] As an example, an I-beam may have different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, a structure or component may be flexible in the first direction and rigid in the second direction.

[0536] 5.10.2 Respiratory and Circulatory Systems Apnea: According to some definitions, apnea is considered to occur when the flow rate drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway prevents airflow even with patient effort. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0537] Respiratory rate: The patient’s spontaneous respiratory rate, usually measured in breaths per minute.

[0538] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0539] Effort (breathing): The effort made by a person who is spontaneously trying to breathe.

[0540] The expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0541] Flow limitation: Flow limitation is considered an event state in a patient's breathing where increased effort does not result in a corresponding increase in flow. Flow limitation occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow limitation. Flow limitation occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow limitation.

[0542] Types of flow-limited inhalation waveforms: (i) Flattened: It has an upward movement, followed by a relatively flat part, and then a downward movement.

[0543] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.

[0544] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.

[0545] (iv) Inverted chair shape: with a relatively flat section followed by a single local peak at the trailing edge.

[0546] Insufficient breathing: By some definitions, insufficient breathing is considered a reduction in flow, rather than a cessation of flow. In one form, insufficient breathing can be considered to have occurred when the flow rate drops below a threshold and persists for a period of time. Central insufficient breathing is considered to have occurred when insufficient breathing is detected due to a reduction in respiratory effort. In one form in adults, any of the following can be considered insufficient breathing: (i) A 30% reduction in the patient's respiration lasting for at least 10 seconds, plus a corresponding 4% reduction in saturation; or (ii) The patient’s breathing is reduced (but at least 50%) for at least 10 seconds, accompanied by a decrease in saturation of at least 3% or arousal.

[0547] Hyperventilation: Increased airflow to above normal levels.

[0548] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0549] Airway openness: The degree to which the airway is open, or the extent to which the airway is open. An open airway is an open airway. Airway openness can be quantified, for example, with a value (1) for open and a value of zero (0) for closed (obstructed).

[0550] Positive end-expiratory pressure (PEEP): The pressure above atmospheric pressure present in the lungs at the end of expiration.

[0551] Peak flow (Qpeak): The maximum flow rate during the expiratory portion of the respiratory flow waveform.

[0552] Respiratory flow, patient air flow, respiratory air flow (Qr): These terms can be understood as the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0553] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, the inspiratory volume Vi (the volume of air inhaled) equals the expiratory volume Ve (the volume of air exhaled), so a single tidal volume Vt can be defined as equal to any quantity. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, such as the average value.

[0554] (Inspiratory) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0555] (Exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0556] (Total) Time (Ttot): The total duration between the start of an inspiratory portion of the respiratory flow waveform and the start of a subsequent inspiratory portion of the respiratory flow waveform.

[0557] Typical recent ventilation: The recent ventilation values ​​(Vent) tend to cluster around their respective values ​​within a predetermined time range, which is a measure of the central tendency of recent ventilation values.

[0558] Upper airway obstruction (UAO): This includes both partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or even decreases as the pressure gradient across the upper airway increases (Starling resistance behavior).

[0559] Ventilation: A measurement of the flow rate of gases exchanged by a patient's respiratory system. A measurement of ventilation can include one or both of inspiratory and expiratory flow rates (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.

[0560] 5.10.3 Ventilation Adaptive Servo Ventilator (ASV): A type of servo ventilator with a variable rather than a fixed target ventilation. The variable target ventilation can be determined from some characteristics of the patient, such as the patient's respiratory characteristics.

[0561] Standby rate: A parameter of the ventilator that determines the minimum rate of breathing (usually measured in breaths per minute) that the ventilator will deliver to the patient if not triggered by spontaneous breathing effort.

[0562] Cyclic: Termination of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, the ventilator cycle is considered to end at the end of the inspiratory portion of the respiratory cycle.

[0563] Positive expiratory airway pressure (EPAP): The base pressure to which the ventilator will attempt to achieve the desired mask pressure at a given time, by adding pressure changes within the respiratory tract.

[0564] End-expiratory pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory phase. (If pressure waveform template...) It is zero at the end of exhalation, that is, when When = 1, If = 0, then EEP equals EPAP.

[0565] Positive inspiratory airway pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory phase of breathing.

[0566] Pressure support: A number indicating the increase in pressure during inspiration that exceeds the pressure during expiration, and generally refers to the pressure difference between the maximum pressure during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference the ventilator is designed to achieve, rather than the difference it actually achieves.

[0567] Servo ventilator: A ventilator that measures a patient’s ventilation volume, has a target ventilation volume, and adjusts the level of pressure support to enable the patient to achieve the target ventilation volume.

[0568] Spontaneous / Timed (S / T): A mode of operation for a ventilator or other device that attempts to detect the initiation of spontaneous breathing in a patient. However, if the device fails to detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.

[0569] Oscillation: A term equivalent to pressure support.

[0570] Triggering: This is said to occur when a ventilator or other respiratory therapy device (such as an RPT device or portable oxygen concentrator) delivers a volume of breathable gas to a patient who is breathing spontaneously. Triggering typically occurs when or near the patient is trying to initiate a breathing portion of the respiratory cycle.

[0571] 5.10.4 Anatomy 5.10.4.1 Facial Anatomy Ala: The outer wall or "wing" of each nostril (plural: alar) Wing angle: Alar tip: the outermost point on the ala of the nose.

[0572] The nasal wing curve (or nasal wing tip) point: the last point on the curve baseline of each nasal wing, which is found in the wrinkle formed by the junction of the nasal wing and the cheek.

[0573] Auricle: The entire visible external part of the ear.

[0574] (Nose) Skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0575] (Nasal) Cartilaginous framework: The cartilaginous framework of the nose includes the septal cartilage, lateral cartilage, major cartilage and minor cartilage.

[0576] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0577] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt plane (the two lines intersect at the lower point of the nasal septum).

[0578] Frankfurt plane: A line extending from the lowest point of the orbital edge to the left oblique region. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0579] The glabella (between the eyebrows): Located on the soft tissue, it is the most prominent point in the sagittal plane at the midline of the forehead.

[0580] Lateral nasal cartilage: generally a triangular cartilaginous plate. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0581] Lower lip (midpoint of lower lip): Upper lip (midpoint of upper lip): Greater alar cartilage: A cartilaginous plate located beneath the lateral nasal cartilage. It curves around the front of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four small cartilages.

[0582] Nostrils (or nasal eyes): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostril (nare) is nasal nasal (naris). The nostrils are separated by the nasal septum.

[0583] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, thus separating the cheeks from the upper lip.

[0584] Nasolabial angle: The angle between the columella and the upper lip (which intersect at the subnasal point).

[0585] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0586] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0587] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0588] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0589] Anterior chin point: Located on the soft tissue, at the anterior midpoint of the chin.

[0590] The nasal ridge (nose): The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal prominence.

[0591] Sagittal plane: A vertical plane running from front to back. The median sagittal plane is the sagittal plane that divides the body into the right and left halves.

[0592] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0593] Septal cartilage (nose): The nasal septum cartilage forms part of the nasal septum and separates the anterior part of the nasal cavity.

[0594] Below the nasal ala: The point at the lower edge of the base of the nasal ala, where the base of the nasal ala joins the skin of the upper (superior) lip.

[0595] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0596] Mandibular alveolar point: The point of maximum concavity located on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue anterior mental point. 5.10.4.2 Anatomical Structure of the Skull Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0597] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0598] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw and below the orbit. The frontal process of the maxilla extends upward from the side of the nose and forms part of the lateral boundary.

[0599] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary among individuals; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0600] Nasal root: the intersection of the frontal bone and the two nasal bones, located directly between the eyes and in the upper part of the bridge of the nose.

[0601] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval foramen (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0602] The eye socket is the bony cavity in the skull that houses the eyeball.

[0603] Parietal bone: The parietal bone is the top and sides of the skull that, when joined together, form the top of the skull.

[0604] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0605] Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the protruding parts of the cheeks.

[0606] 5.10.4.3 Anatomical Structure of the Respiratory System Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0607] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0608] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0609] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular: "nasal conchae"). The front of the nasal cavity is the nasal part, while the back connects to the nasopharynx via the internal nasal openings.

[0610] Pharynx: The part of the throat located below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three segments: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0611] 5.10.5 Patient Interface Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0612] Bend: A bend is an example of a structure that directs the axis of an airflow traveling through it by an angle. In one form, this angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. A bend can have an approximately circular cross-section. In another form, a bend can have an elliptical or rectangular cross-section. In some forms, the bend can rotate relative to the mating component, for example, by approximately 360 degrees. In some forms, the bend can be removed from the mating component, for example, via a snap fastener. In some forms, the bend can be assembled to the mating component during manufacturing via a disposable snap fastener, but cannot be removed by the patient.

[0613] Frame: The frame is generally considered to refer to the mask structure that bears the tensile load between two or more points of connection with the head strap. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0614] Headband: A headband is considered to refer to a form of positioning and stabilizing structure designed for use on the head. For example, a headband may include an assembly of one or more supports, straps, and reinforcements configured to position and hold the patient interface on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, resilient materials, such as laminated composites of foam and fabric.

[0615] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0616] Pneumatic chamber: A mask pneumatic chamber will be understood as part of a patient interface having a wall that at least partially surrounds a volume of space, which, in use, is inflated to a pressure exceeding atmospheric pressure. An outer shell may form part of the wall of the mask pneumatic chamber.

[0617] Sealing: can refer to the noun form of a structure ("seal") or the verb form of the effect ("seal"). Two elements can be constructed and / or arranged to 'seal' or to achieve 'seal' between them, without the need for a separate 'seal' element itself.

[0618] Shell: The shell is considered to be a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural wall of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0619] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0620] Support: A support is considered to be a structural component designed to increase the compressibility of another component in at least one direction.

[0621] Rotary shaft (noun): A sub-assembly of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotary shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the rotary shaft may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery conduits, the sub-assembly of the component preferably comprises a pair of mating cylindrical conduits. During use, there may be little or no airflow leakage from the rotary shaft.

[0622] Lacing (noun): A structure designed to resist tension.

[0623] Ventilation port (noun): A structure that allows airflow from inside a mask or cannula to ambient air for clinically effective flushing of exhaled gases. For example, clinically effective flushing can involve a flow rate from about 10 liters per minute to about 100 liters per minute, depending on the mask design and treatment pressure.

[0624] 5.10.6 Shape of the structure Products according to this technology may include one or more three-dimensional mechanical structures, such as mask pads or thrusters. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a surface that contacts the face (e.g., the outer surface) and separate surfaces that do not contact the face (e.g., the underside or inner surface). In another example, a structure may include a first surface and a second surface.

[0625] To aid in describing the shape of three-dimensional structures and surfaces, first consider the cross-section of the surface passing through the structure at point p. See also Figures 3B to 3F These examples show a cross-section at point p on the surface and the resulting planar curve. The resulting plane is curved on the surface. Figures 3B to 3F The diagram also illustrates the outward normal vector at point p. The outward normal vector at point p is located away from the surface. In some examples, the surface is depicted from the viewpoint of an imaginary figure standing upright on the surface.

[0626] 5.10.6.1 Curvature in one dimension The curvature of a plane curve at P can be described with a sign (e.g., positive, negative) and a quantity (e.g., the reciprocal of the radius of the circle that only touches the curve at P).

[0627] Positive curvature: If the curve turns outwards towards the normal at point p, then the curvature at that point is positive (if the figures were to leave point p, they would have to walk uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to relatively small positive curvature). Such curves are often referred to as concave surfaces.

[0628] Zero curvature: If the curve is a straight line at point p, then the curvature will be zero (if the imaginary figures left point p, they could walk horizontally, neither up nor down). See also Figure 3D .

[0629] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if you imagine little people leaving point p, they must go downhill). See also Figure 3E (and Figure 3F Compared to relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to relatively large negative curvature). Such curves are often referred to as convex surfaces.

[0630] 5.10.6.2 Curvature of Two-Dimensional Surfaces A description of the shape at a given point on a two-dimensional surface according to the present invention may include multiple normal cross sections. These cross sections may cut through the surface in a plane including an outward normal (“normal plane”), and each cross section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has a quantity, for example, a relatively small quantity. Figures 3B to 3F A planar curve in a diagram can be an example of multiple cross sections at a specific point.

[0631] Principal curvature and direction: The normals to the curves where the curvature reaches its maximum and minimum values ​​are called principal directions. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, the minimum curvature appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross-section along the principal direction. The principal curvature at p is the curvature along the principal direction.

[0632] Surface region: A set of connected points on a curved surface. The points in this region may have similar characteristics, such as curvature or sign.

[0633] Saddle-shaped region: a region in which the principal curvature has opposite signs at each point, i.e., one sign is positive and the other sign is negative (which may be going up or down depending on the direction the imagined individual is turning).

[0634] Vault region: A region in which the principal curvature has the same sign at each point, such as two positive ("concave vault") or two negative ("convex vault").

[0635] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is not zero.

[0636] Planar region: A surface region where both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0637] Surface edge: The boundary or limit of a surface or region.

[0638] Path: In some forms of this technique, 'path' will mean a path in a mathematical-topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, 'path' can be described as a route or process, including, for example, a set of points on a surface. (Imagined individual paths are those in which they travel on a surface and resemble garden paths).

[0639] Path length: In some forms of this technique, 'path length' will be considered to represent the distance along the surface from f(0) to f(1), i.e., the distance along a path on the surface. There can be more than one path between two points on the surface and such paths can have different path lengths. (The path length of an imagined individual would be the distance they walk along the path on the surface).

[0640] Straight-line distance: Straight-line distance is the distance between two points on a surface, but it is independent of the surface itself. In a planar region, a path with the same length as the straight-line distance between two points on the surface can exist on the surface. In a non-planar surface, a path with the same length as the straight-line distance between two points may not exist. (For an imaginary individual, straight-line distance will correspond to the distance as a 'straight line'.)

[0641] 5.10.6.3 Space Curves Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, that is, without endpoints. A space curve can be thought of as a one-dimensional segment of three-dimensional space. An imaginary human walking along one strand of a DNA helix travels along a space curve. The typical human left ear contains the helix, which is a left-handed helix; see [link to relevant documentation]. Figure 3Q The typical human right ear includes a spiral, which is a right-handed spiral; see [link / reference]. Figure 3R . Figure 3S A right-handed helix is ​​shown. The edges of a structure, such as the edges of a membrane or impeller, can follow a space curve. Typically, a space curve can be described by the curvature and torsion at each point on the space curve. Torque is a measure of how the curve deviates from the plane. Torque has a sign and magnitude. The torsion at a point on a space curve can be characterized by reference to the tangent vector, normal vector, and double normal vector at that point.

[0642] 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. The tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If a hypothetical person were flying along the curve and falling from their aircraft at a specific point, the direction of the tangent vector would be the direction they would have traveled.

[0643] Unit normal vector: This is the vector that changes as an imaginary person moves along the curve. The unit vector pointing in the direction of the change of the tangent vector is called the principal normal vector. It is perpendicular to the tangent vector.

[0644] A double-normal unit vector is a unit vector that 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, [reference needed]). Figure 3P ) or optionally by left-hand rule ( Figure 3O To determine.

[0645] Sagittal plane: The plane containing the unit tangent vector and the unit principal normal vector. See Appendix. Figure 3O and 3P .

[0646] Torsion of a space curve: The torsion of a space curve at a point is the magnitude of the rate of change of the unit binormal vector at that point. It measures the degree to which the curve deviates from the sagittal plane. A space curve lying in the plane has zero torsion. A space curve deviating relatively small from the plane will have a relatively small amount of torsion (e.g., a gently sloping spiral path). A space curve deviating relatively large from the sagittal plane will have a relatively large amount of torsion (e.g., a sharply sloping spiral path). See also Figure 3S Since T2 > T1, the amount of twist near the top coil of the spiral in Figure 3 is greater than that of T1. Figure 3S The amount of twist of the bottom coil of the spiral.

[0647] Reference Figure 3P According to the right-hand rule, a space curve oriented towards the right-hand side of the double normal direction can be considered to have a right-hand positive twist (e.g., Figure 3S (The right-handed spiral shown). A space curve that turns away from the direction of the right-hand double normal can be considered to have a right-handed negative twist (e.g., a left-handed spiral).

[0648] Similarly, refer to the left-hand rule (see...) Figure 3O A space curve pointing towards the left-hand double normal direction can be considered to have a left-hand positive twist (e.g., a left-hand spiral). Therefore, left-hand positive is equivalent to right-hand negative. See also Figure 3T .

[0649] 5.10.6.4 Hole Surfaces can have one-dimensional pores, for example, pores defined by planar or spatial curves. Thin structures with pores (e.g., films) can be described as having one-dimensional pores. See, for example, [example missing]. Figure 3I The structure shown has a one-dimensional hole in the surface bounded by a planar curve.

[0650] The structure can have two-dimensional pores, such as pores defined by a surface. For example, an inflatable tire has two-dimensional pores defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have two-dimensional pores. See, for example, [link to relevant documentation]. Figure 3L padding and through Figure 3M and Figure 3N An exemplary cross-section is shown, illustrating the inner surface defining a two-dimensional orifice. In yet another example, a conduit may include a one-dimensional orifice (e.g., at its inlet or outlet) and a two-dimensional orifice defined by the inner surface of the conduit. See also Figure 3K The structure shown has a two-dimensional hole whose boundary is defined by the surface shown.

[0651] 5.11 Other Remarks This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of these patent documents or patent disclosures by any person in the form they appear in the patent office documents or records, but otherwise reserves all copyright rights.

[0652] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other value or intermediate value within the range are broadly included within this technique. The upper and lower limits of these intermediate ranges may be included independently within the intermediate range and within the scope of this technique, but are subject to any explicitly excluded boundaries within the range. Where the range includes one or both of the extreme values, this technique also includes ranges that exclude any one or both of those included extreme values.

[0653] Furthermore, in cases where one or more values ​​described herein are implemented as part of this technique, it should be understood that such values ​​may be approximate unless otherwise stated, and the extent to which such values ​​may be used in practical technical implementations is permitted or required for any appropriate number of digits.

[0654] 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 pertains. While any methods and materials similar to or equivalent to those described herein may also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0655] When a particular material is determined to be used for constructing a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0656] It must be noted that, unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” used herein and in the appended claims include their plural equivalents.

[0657] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. This document should not be construed as an admission that the present technology is not entitled to any prior disclosure due to a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0658] The terms “comprising” and “including” should be interpreted as meaning that an element, component, or step referenced in a non-exclusive manner may be presented together, used together, or combined with other elements, components, or steps that are not explicitly referenced.

[0659] The headings used in the detailed description are for convenience of the reader only and should not be used to limit the subjects that can be found throughout the invention or the claims. These headings should not be used to interpret or limit the scope of the claims.

[0660] Although the techniques described herein have been illustrated with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may imply specific details not required for the practice of the techniques. For example, although the terms “first” and “second” may be used, they are not intended to indicate any order unless otherwise stated, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects may be performed simultaneously or even concurrently.

[0661] Therefore, it should be understood that many modifications can be made to the illustrative examples and other arrangements can be designed without departing from the spirit and scope of this technology.

Claims

1. A positioning and stabilization structure for a patient interface, comprising: A front section and a rear section are formed to form a continuous material ring, wherein the front section forms a first bifurcation section having a first portion and a second portion; The upper fabric portion includes an elastic circumferential band for fitting onto a patient's head during use, the upper fabric portion being formed by the rear section and the first portion; as well as At least one lower fabric portion is formed by the second portion and is movably connected to the upper fabric portion; At least one first lower fabric portion of the at least one lower fabric portion is stretchable relative to the upper fabric portion and is configured and arranged to provide a force for holding the sealing structure of the patient interface in a therapeutically effective position on the patient's head. as well as The first lower fabric portion is movable between a first position and a second position, the first lower fabric portion being configured to be close to the first portion and covering the patient's frontal bone in the first position, and the first lower fabric portion being configured to be away from the first portion and covering the patient's cheek in the second position.

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

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

4. The positioning and stabilizing structure according to any one of claims 1 to 3, wherein the rear section of the headband includes a second bifurcated section, the second bifurcated section including a second portion of the upper fabric portion and further including a second lower fabric portion.

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

6. The positioning and stabilizing structure according to claim 4 or 5, wherein the front portion and the rear portion combine to form an X shape at the second position.

7. The positioning and stabilizing structure according to any one of claims 1 to 6, wherein the first lower fabric portion is a sealing retainer band, the sealing retainer band being elastically stretchable along at least a portion of its length and adapted to engage with the outer surface of the patient interface to retain the sealing structure in the therapeutically effective position.

8. The positioning and stabilizing structure according to claim 7, wherein the sealing retaining strip is more stretchable than the upper fabric portion.

9. The positioning and stabilizing structure according to claim 7 or 8, wherein the sealing retaining strip is adapted to be received in the channel of the patient interface.

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

11. The positioning and stabilizing structure according to any one of claims 7 to 10, wherein the sealing retaining strip includes a port for connecting the sealing forming structure to an air circuit for supplying pressurized air to the patient.

12. The positioning and stabilizing structure according to claim 1 or 2, comprising a pair of lower fabric portions adapted to be coupled to each other and / or coupled to an intermediate structure to provide the force.

13. The positioning and stabilizing structure according to claim 12, wherein the intermediate structure is a strap that holds the sealing structure in the effective therapeutic position during use.

14. The positioning and stabilizing structure according to claim 12, wherein the intermediate structure includes the sealing forming structure or a portion thereof.

15. The positioning and stabilizing structure according to any one of claims 1 to 14, wherein at least one of the lower fabric portions comprises one or more rigid portions.

16. The positioning and stabilizing structure of claim 15, wherein the stiffness of at least one of the lower fabric portions is higher in its middle section than in its end section.

17. The positioning and stabilizing structure according to any one of claims 1 to 16, comprising at least one sensor disposed in or on the upper fabric portion and / or one or more lower fabric portions.

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

19. The positioning and stabilizing structure of claim 18, wherein the at least one sensor and / or the at least one actuator is partially exposed to the surrounding environment at the outer surface of the upper fabric portion or the one or more lower fabric portions; and / or partially exposed at the patient contact surface of the upper fabric portion or the one or more lower fabric portions to contact the patient's skin in use.

20. The positioning and stabilization structure according to claim 18 or 19, wherein the at least one sensor and / or the at least one actuator is at least partially embedded between the outer layer of the upper fabric portion or one or more lower fabric portions and the patient contact layer.

21. The positioning and stabilizing structure according to 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 partially by one or more conductive lines and / or one or more conductive ink lines.

22. The positioning and stabilizing structure according to any one of claims 18 to 21, comprising at least one sensor holding structure for attaching the at least one sensor and / or a corresponding sensor in the at least one actuator.

23. The positioning and stabilization structure of claim 22, wherein the at least one sensor holding structure includes at least one pocket for receiving the at least one sensor and / or the at least one actuator.

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

25. The positioning and stabilization structure according to 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 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.

26. A patient interface, comprising: A pneumatic chamber, capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the inlet port being sized and structured to receive airflow for patient respiration at the treatment pressure. A sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet. The sealing structure has an opening therein, allowing airflow at the therapeutic pressure to be delivered at least to the inlet of the patient's nostrils. The sealing structure is configured and arranged to maintain the therapeutic pressure in the pneumatic chamber throughout the patient's respiratory cycle during use. The positioning and stabilizing structure is configured to provide forces that hold the sealing structure in a therapeutically effective position on the patient's head; The positioning and stabilizing structures include: A front section and a rear section forming a continuous ring of material, wherein the front section forms a first bifurcation section having a first portion and a second portion; The upper fabric portion includes an elastic circumferential band for fitting onto a patient's head in use, the upper fabric portion being formed by the rear segment and the first portion; and At least one lower fabric portion is formed by the second portion and is movably connected to the upper fabric portion; At least one first lower fabric portion of the at least one lower fabric portion is stretchable relative to the upper fabric portion and is configured and arranged to provide a force for holding the sealing structure of the patient interface in a therapeutically effective position on the patient's head. The first lower fabric portion is movable between a first position and a second position, the first lower fabric portion being configured to be close to the first portion and covering the patient's frontal bone in the first position, and the first lower fabric portion being configured to be away from the first portion and covering the patient's cheek in the second position.

27. The patient interface of claim 26, wherein the first lower fabric portion is integral with the upper fabric portion.

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

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

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

31. The positioning and stabilizing structure according to claim 29 or 30, wherein the front portion and the rear portion combine to form an X shape at the second position.

32. The patient interface according to any one of claims 26 to 31, wherein the first lower fabric portion is a sealing retainer band, at least a portion of which is elastically stretchable along its length and adapted to engage with the outer surface of the pneumatic chamber or the sealing formation to retain the sealing formation in the therapeutically effective position.

33. The patient interface of claim 32, wherein the sealing retainer is more stretchable than the upper fabric portion.

34. The patient interface according to claim 32 or 33, wherein the sealing retaining strip is received in the channel of the patient interface.

35. The patient interface of claim 34, wherein the channel is formed in the outer surface of the pneumatic chamber.

36. The patient interface according to any one of claims 32 to 35, wherein the sealing retainer includes a port for connecting the pneumatic chamber inlet port to an air circuit for supplying pressurized air to the patient.

37. The patient interface of claim 26 or 27, wherein the positioning and stabilizing structure comprises a pair of lower fabric portions adapted to be coupled to each other and / or coupled to an intermediate structure to provide the force.

38. The patient interface of claim 37, wherein the intermediate structure is a strap that engages with the outer surface of the pneumatic chamber or the outer surface of the sealing structure during use.

39. The patient interface of claim 37, wherein the intermediate structure comprises the pneumatic chamber and / or the sealing formation structure or a portion thereof.

40. The patient interface according to any one of claims 26 to 39, wherein at least one of the pair of lower fabric portions comprises one or more rigid portions.

41. The patient interface of claim 40, wherein the at least one pair of lower fabric portions has higher rigidity in its middle section than at its ends.

42. The patient interface according to any one of claims 26 to 41, comprising at least one sensor disposed in or on the upper fabric portion, and / or at least one of the pair of lower fabric portions, and / or the pneumatic chamber, and / or the sealing formation.

43. The patient interface of claim 42, comprising at least one actuator disposed in or above the upper fabric portion, and / or the at least one pair of lower fabric portions, and / or the pneumatic chamber, and / or the sealing formation.

44. The patient interface of claim 43, wherein at least one sensor and / or at least one actuator is partially exposed to the surrounding environment at the outer surface of the upper fabric portion or the at least one pair of lower fabric portions; and / or partially exposed at the patient contact surface of the upper fabric portion or the at least one pair of lower fabric portions to contact the patient's skin in use.

45. The patient interface according to claim 43 or 44, wherein at least one sensor and / or at least one actuator is at least partially embedded between the outer layer of the upper fabric portion or the at least one pair of lower fabric portions and the patient contact layer.

46. ​​The patient interface according to any one of claims 43 to 45, wherein at least one sensor and / or the at least one actuator comprises circuitry at least partially formed of one or more conductive lines and / or one or more conductive ink lines.

47. The patient interface according to any one of claims 43 to 46, comprising at least one sensor holding structure for attaching a corresponding sensor and / or actuator.

48. The patient interface of claim 47, wherein the at least one sensor holding structure includes one or more pockets for receiving the at least one sensor and / or the at least one actuator.

49. The 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 for receiving data from the at least one external computing device at the at least one actuator.

50. The patient interface according to any one of claims 43 to 49, wherein the at least one sensor and / or the at least one actuator comprises 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.

51. The patient interface of claim 50, wherein the at least one sensor comprises at least one pressure sensor in fluid communication with the pneumatic chamber.

52. The patient interface according to any one of claims 26 to 51, wherein the pneumatic chamber comprises a housing and has an inner surface and an outer surface, wherein the inner surface is configured to be at the treatment pressure during use, and the outer surface is configured to be at ambient pressure during use.

53. The patient interface of claim 52, wherein at least one of the pair of lower fabric portions engages with at least a portion of the outer surface of the housing to retain the sealing structure in the therapeutically effective position.

54. The patient interface according to claim 53, which is dependent on claim 34, wherein the channel is formed in the outer surface of the housing.

55. The patient interface according to any one of claims 52 to 54, wherein the housing is made of a hard plastic material.

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

57. The patient interface according to any one of claims 52 to 56, wherein the housing is made of a transparent material.

58. The patient interface according to any one of claims 52 to 57, wherein the housing is coupled to the sealing formation.

59. A positioning and stabilization structure for a patient interface, comprising: A headband, at least partially formed of a fabric material and having an upper fabric portion movably connected to a first lower fabric portion, the headband including at least one sensor provided in or above the upper fabric portion and / or the first lower fabric portion; The headband is wearable on a patient's head in a first configuration and a second configuration. In the first configuration, the first lower fabric portion is adjacent to the upper fabric portion and is configured to cover the patient's forehead. In the second configuration, the first lower fabric portion is separated from the upper fabric portion and provides force to hold the sealing structure of the patient interface in a therapeutically effective position on the patient's head. The first lower fabric portion is configured to cover the patient's cheeks in the second configuration.

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

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 surrounding environment at the outer surface of the upper fabric portion or the first lower fabric portion; and / or partially exposed at the patient contact surface of the upper fabric portion or the first lower fabric portion so as to contact the patient's skin in use.

62. The positioning and stabilization structure according to claim 60 or 61, wherein at least one sensor and / or at least one actuator is at least partially embedded between the outer layer of the upper fabric portion or the first lower fabric portion and the patient contact layer.

63. The positioning and stabilizing structure according to any one of claims 60 to 62, wherein at least one sensor and / or at least one actuator comprises a circuit formed at least partially by one or more conductive lines and / or one or more conductive ink lines.

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

65. The positioning and stabilization structure of claim 64, wherein the one or more sensor holding structures include one or more pockets to accommodate one or more respective sensors or actuators.

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

67. The positioning and stabilization structure according to 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 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.

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

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

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

71. The positioning and stabilizing structure according to any one of claims 59 to 70, wherein the first lower fabric portion is a sealing retainer band, the sealing retainer band being elastically stretchable along at least a portion of its length and adapted to engage with the outer surface of the patient interface to retain the sealing structure in the therapeutically effective position.

72. The positioning and stabilizing structure of claim 71, wherein the sealing retaining strip is more stretchable than the upper fabric portion.

73. The positioning and stabilizing structure according to claim 71 or 72, wherein the sealing retaining strip is adapted to be received in the channel of the patient interface.

74. The positioning and stabilizing structure according to claim 73, wherein the channel is formed in the pneumatic chamber of the patient interface.

75. The positioning and stabilizing structure according to any one of claims 71 to 74, wherein the sealing retaining strip includes a port for connecting the sealing forming structure to an air circuit for supplying pressurized air to the patient.

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

77. The positioning and stabilizing structure of claim 76, wherein the first lower fabric portion has higher rigidity in its middle section than at its ends.

78. The positioning and stabilizing structure according to any one of claims 59 to 77, wherein at least one elastic hook is located on the first lower fabric portion, said at least one elastic hook being configured to connect to one or more protrusions or recesses on the pneumatic chamber and / or sealing forming structure.

79. A patient interface, comprising: A pneumatic chamber, capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pneumatic chamber including a pneumatic chamber inlet port, the inlet port being sized and structured to receive airflow for patient respiration at the treatment pressure. A sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet. The sealing structure has an opening therein, allowing airflow at the therapeutic pressure to be delivered at least to the inlet of the patient's nostrils. The sealing structure is configured and arranged to maintain the therapeutic pressure in the pneumatic chamber throughout the patient's respiratory cycle during use. The positioning and stabilizing structure according to any one of claims 58 to 78.

80. The patient interface of claim 79, further comprising one or more sensors located in or on the inner surface of the pneumatic chamber.

81. The patient interface of claim 80, wherein the one or more sensors include one or more of the following: a pressure sensor; a humidity sensor; a temperature sensor; and a CO2 sensor.

82. A system for diagnosing and / or monitoring respiratory disturbances, comprising: Patient interface according to any one of claims 42 to 58 or 79 to 81; And at least one computing device that communicates with the patient interface to receive data from the one or more sensors of the patient interface.

83. A system for treating a patient's respiratory disorder, the system comprising: Patient interface according to any one of claims 42 to 58 or 79 to 81; A pressure generator is configured to generate an airflow to the patient interface in order to treat the breathing disorder; and The controller is configured to control the pressure generator to regulate the airflow based on at least one signal received from at least one sensor of the patient interface.

84. The system of claim 83, wherein the at least one sensor of the patient interface comprises an EMG and / or an EOG sensor, and wherein the controller is configured to: analyze the at least one signal to detect the patient's sleep stage; and 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 noise.

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

86. The system according to any one of claims 83 to 85, wherein the at least one sensor comprises a humidity sensor and a temperature sensor inside the pneumatic chamber; and wherein the controller is configured to control the pressure generator to adjust the airflow based on signals from the humidity sensor and the temperature sensor, thereby reducing or preventing condensation buildup.

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

88. The system according to any one of claims 83 to 88, wherein the at least one sensor includes a CO2 sensor inside the pneumatic chamber; and wherein the controller is configured to: detect whether the CO2 level measured by the CO2 sensor is higher than a threshold; and control the patient interface and / or pressure generator based on the detected signal to reduce the CO2 level.

89. The system of claim 88, wherein the controller is configured to send a signal to the patient interface to open an electromechanical vent communicating with the pneumatic chamber, thereby allowing for higher flushing of air from the pneumatic chamber.

90. The system of claim 88 or 89, wherein the controller is configured to control the pressure generator to increase the flow rate of flushing CO2.

91. The system according to any one of claims 83 to 90, which are dependent on claim 44, wherein: One or more actuators in the patient interface include haptic feedback elements.

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

93. The system of claim 91 or claim 92, wherein the at least one sensor comprises a pulse oximeter; and wherein 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 lower than that of the heart rate measurement.

94. The system according to any one of claims 91 to 93, wherein the controller is configured to: analyze the at least one signal to detect whether the number of sleep positions and / or apnea and / or hypopnea events of the patient exceeds a threshold; and based on the detection, send a control signal to the tactile feedback element to deliver tactile stimulation to the patient.

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

96. The system according to claim 95, wherein: The pressure increases slowly when the detected signal indicates that the patient should lie supine; When the detected signal indicates that the patient is in a lateral decubitus position, reduce the pressure; as well as When the detected signal indicates that the patient is in an upright position, the flow rate and pressure are reduced below the treatment pressure.

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

98. The system according to claim 97, wherein: When a detected motion signal indicates high motion, the controller is configured to control the pressure generator to adjust the pressure below the treatment pressure; as well as When the detected motion signal indicates a low level of motion, the controller is configured to control the pressure generator to gradually adjust the pressure toward the therapeutic pressure.

Images