Forehead cooling system

Abstract

The present technology relates to a forehead cooling system configured for use with a patient interface to aid in the treatment of sleep and respiratory disorders. Examples of the present technology include fluid cooling systems, such as air cooling and water cooling. Other examples use phase change materials and thermoelectric coolers. In some examples, the forehead cooling system may be attached to a positioning and stabilizing structure.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of Australian Provisional Patent Application No. 2023902322, filed on 21 July 2023, the contents of which are incorporated herein by reference in their entirety. Background Technology 2.1 Technical Field

[0004] 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.

[0005] 2.2 Description of related technologies

[0006] 2.2.1 The human respiratory system and its disorders

[0007] The human respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airway.

[0008] 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 move from inhaled air into the venous blood and allowing carbon dioxide to move in opposite directions. The trachea divides into the left and right main bronchi, which eventually branch into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branches of the airways lead to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See John B. West's *Respiratory Physiology*, 9th edition, Lippincott Williams & Wilkins, 2012.

[0009] A range of breathing disorders exist. Some disorders may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

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

[0011] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It is caused by a combination of abnormally small loss of normal upper airway and muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can cause cardiovascular disease and brain damage. The syndrome is a common disorder, especially in middle-aged overweight men, but those affected may not be aware of the problem, see, for example, U.S. Patent No. 4,944,310 (Sullivan).

[0012] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as the CSR cycle. CSR is characterized by repeated deoxygenation and reoxidation of arterial blood. CSR can be harmful due to repetitive hypoxia. In some patients, CSR is associated with recurrent awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload, see, for example, U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] 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.

[0014] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0015] 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.

[0016] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These include increased air 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.

[0017] Neuromuscular disease (NMD) is a broad term encompassing many conditions 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 over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). 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 swings.

[0018] Chest wall disorders are a group of chest wall deformities that result in 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.

[0019] A range of therapies have been used to treat or improve these conditions. Furthermore, other healthy individuals can utilize these therapies to prevent respiratory distress. However, these have many drawbacks.

[0020] 2.2.2 Treatment

[0021] Various respiratory therapies, such as positive airway pressure (PAP) therapy including 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.

[0022] 2.2.2.1 Respiratory pressure therapy

[0023] Respiratory pressure therapy is the application of 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 chest tubes).

[0024] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure 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 therapy can be voluntary, and therefore patients may choose not to adhere to the therapy if they find the device used to provide such therapy to be uncomfortable, difficult to use, expensive, or unsightly.

[0025] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to assist breathing and / or maintain adequate oxygen levels by performing some or all of the work of breathing. Ventilation support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

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

[0027] 2.2.2.2 Flow Therapy

[0028] 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 other cases, 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 can be maintained substantially 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 dead space therapy (DST). Other benefits may include increased warmth and humidification (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.

[0029] 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 into the patient's airway at a specific oxygen concentration (from 21% to 100% of the oxygen fraction in ambient air) and at a specific flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0030] 2.2.3 Respiratory Therapy System

[0031] 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 a condition without treating it.

[0032] 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.

[0033] 2.2.3.1 Patient Interface

[0034] Patient interfaces can be used to attach breathing equipment to their wearer, for example, by providing an airflow to the airway inlet. The airflow can be provided to the patient's nose and / or mouth via a mask, to the patient's mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy to be applied, the patient interface can form a seal with, for example, an area of ​​the patient's face to facilitate the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure). For other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply to the airway at a positive pressure of approximately 10 cmH2O. For flow-through therapy such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0035] Some mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain proper 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 pressure.

[0036] Certain masks may be clinically disadvantageous for this technique, for example, if they block airflow through the nose and only allow it through the mouth.

[0037] If patients need to insert part of the mask structure into their mouths to create and maintain a seal through their lips, some masks may be uncomfortable or impractical for this technique.

[0038] Some face masks may be impractical to use while sleeping, such as when lying on your side in bed with your head on a pillow.

[0039] Some masks may cause some patients to experience claustrophobia, discomfort, and / or may feel excessively unpleasant.

[0040] 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 considerably between individuals. Because the head comprises bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jawbone or mandible can move relative to the other bones of the skull. The entire head can move during respiratory therapy.

[0041] Therefore, some masks have disadvantages such as protrusion, undesirable aesthetics, high cost, poor fit, difficulty in use, and / or discomfort, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized mask can lead to reduced adherence, decreased comfort, and poorer patient outcomes. Masks designed solely for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks used for the administration of anesthetics may be tolerable for their original application; however, such masks can still be undesirably uncomfortable when worn for extended periods (e.g., several hours). This discomfort can lead to decreased patient adherence to therapy, particularly if the mask is worn during sleep.

[0042] CPAP therapy is highly effective for treating certain respiratory conditions, provided the patient adheres to the regimen. Patients may not adhere to the regimen if the mask is uncomfortable or difficult to use. Because patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean it, and this can affect patient adherence.

[0043] While masks designed for other applications (such as navigators) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0044] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0045] 2.2.3.1.1 Sealing Formation Structure

[0046] Patient interfaces may include seal-forming structures. Because the seal-forming structures come into direct contact with the patient's face, their shape and configuration can directly affect the effectiveness and comfort of the patient interface.

[0047] The patient interface can be partially characterized based on 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. This single element may be designed, for example, to cover the upper lip region and the middle nasal 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 known by their manufacturers under various names, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0048] A seal that works in one area of ​​a patient's face may be unsuitable in another, for example, due to the different shapes, structures, variability, and sensitive areas of the patient's face. For instance, a seal on swimming goggles covering a patient's forehead may not be suitable for use on a patient's nose.

[0049] Certain seal-forming structures can be designed for mass production, allowing a design to fit comfortably and effectively for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the patient's facial shape and the seal-forming structure of the mass-produced patient interface, one or both must be modified to form a seal.

[0050] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface during face-to-face engagement. This seal-forming structure may include an air- or fluid-filled pad, or a molded or formed surface of an elastic sealing element made of an elastomer (e.g., 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.

[0051] Another type of seal-forming structure incorporates a valve seal made of a thin material located around the periphery 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 buckle during use, causing leakage.

[0052] Another type of sealing structure may include friction-fitting elements, such as those for insertion into the nostrils; however, some patients find these uncomfortable.

[0053] Another form of seal formation can be achieved using adhesives. Some patients may find it inconvenient to frequently apply and remove adhesives from their face.

[0054] A series of patient interface sealing structure technologies are disclosed in the following patent applications: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0055] One form of nasal pillow is found in the Adam circuitry manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0056] ResMed Inc. has manufactured the following products incorporating nasal pillows: SWIFT™ Nasal Pillow Cover, SWIFT™ II Nasal Pillow Cover, SWIFT™ LT Nasal Pillow Cover, SWIFT™ FX Nasal Pillow Cover, and MIRAGE LIBERTY™ Full Cover. Examples of nasal pillow covers are described in the following patent applications: International Patent Application WO 2004 / 073778 (particularly describing aspects of the SWIFT™ Nasal Pillow Cover); U.S. Patent Application 2009 / 0044808 (particularly describing aspects of the SWIFT™ LT Nasal Pillow Cover); International Patent Applications WO 2005 / 063328 and WO 2006 / 130903 (particularly describing aspects of the MIRAGE LIBERTY™ Full Cover); and International Patent Application WO 2009 / 052560 (particularly describing aspects of the SWIFT™ FX Nasal Pillow Cover).

[0057] 2.2.3.1.2 Positioning and Stabilizing Structure

[0058] The seal-forming structure of a patient interface used in pneumatic therapy is subject to the corresponding force of pneumatic pressure that can disrupt the seal. Therefore, various techniques have been used to position the seal-forming structure and maintain it in a sealed relationship with the appropriate portion of the face. Several factors can be considered when comparing different positioning and stabilization techniques. These include: how effective the technique is at holding the seal-forming structure in the desired position and sealing it against the face during patient interface use; how comfortable the interface is for the patient; whether the patient experiences invasiveness and / or claustrophobia while wearing the patient interface; and aesthetic appeal.

[0059] 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.

[0060] Another technique involves using one or more straps and / or stabilizing straps. Many of these straps suffer from one or more problems, such as poor fit, bulkiness, discomfort, and inconvenience of use.

[0061] 2.2.3.1.3 Pressurized air duct

[0062] In one type of treatment system, pressurized airflow is supplied to the patient interface via a conduit in an air circuit. When the patient interface is positioned over the patient's face during use, the air circuit is fluidly connected to the patient interface at a location in front of the patient's face. The conduit can extend forward from the patient interface away from the patient's face.

[0063] 2.2.3.1.4 Pressurized air ducts used for positioning / stabilizing the sealing structure

[0064] Another type of treatment system includes a patient interface in which the tubing that delivers pressurized air to the patient's airway also serves as part of a headgear to position and stabilize a sealing portion of the patient interface in the appropriate part of the patient's face. This type of patient interface may be referred to as having a "catheter headgear" or "headgear tubing." Such a patient interface allows a catheter in the air circuit providing a flow of pressurized air from a respiratory pressure therapy (RPT) device to be connected to the patient interface at a location other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication No. 2007 / 0246043, the contents of which are incorporated herein by reference, wherein the catheter is connected to the tubing in the patient interface via a port positioned on the top of the patient's head during use.

[0065] Ideally, when the patient is asleep, the patient interface with a head cannula should be comfortable for the patient to wear for an extended period of time, forming an airtight and stable seal with the patient's face, while also being adaptable to a range of patient head shapes and sizes.

[0066] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0067] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the various therapies described above, such as by operating the device to generate an airflow for delivery to an interface in the airway. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow-based therapies such as HFT). Therefore, an RPT device can also function as a flow-based therapy device. Examples of RPT devices include PAP devices and ventilators.

[0068] Pneumatic generators are known in a range of applications, such as industrial-scale ventilation systems. However, pneumatic generators for medical applications have specific requirements that more general pneumatic generators cannot meet, such as reliability, size, and weight requirements for medical devices. Furthermore, even devices designed for medical use may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.

[0069] One example of a specific requirement for certain RPT devices is acoustic noise.

[0070] Noise output level table for existing RPT devices (only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0071]

[0072] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Inc. Another example of an RPT device is a ventilator. Ventilators, such as the ResMed Stellar™ series of adult and pediatric ventilators, can provide invasive and non-invasive non-dependent ventilatory support for a range of patients to treat various conditions, including but not limited to NMD, OHS, and COPD.

[0073] The ResMed Elisée™ 150 and ResMed VS III™ ventilators provide support for invasive and non-invasive ventilation in adults and pediatric patients for the treatment of a variety of conditions. These ventilators offer volumetric and pressure-dependent ventilation modes via single- or dual-branch circuits. RPT devices typically include a pressure generator, such as a motor-driven blower or compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, the airflow can be supplied to the patient's airway at positive pressure. The RPT device outlet is connected via an air circuit to a patient interface such as those described above.

[0074] Device designers may face an infinite number of choices. Design standards often conflict, meaning that some design choices are unconventional or unavoidable. Furthermore, comfort and efficiency in certain aspects may be highly sensitive to minute variations in one or more parameters.

[0075] 2.2.3.3 Air Circuit

[0076] An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system, such as the RPT device and the patient interface, during use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation. In other cases, a single branch air circuit is used for both inhalation and exhalation.

[0077] 2.2.3.4 Humidifier

[0078] Delivering airflow without humidification can lead to airway dryness. Using a humidifier with an RPT device and patient interface generates humidified gas, which minimizes nasal mucosal dryness and increases patient airway comfort. Additionally, in colder climates, warm air applied to the area within and around the patient interface is generally more comfortable than cold air.

[0079] 2.2.3.5 Ventilation port technology

[0080] Some forms of therapeutic systems may include a vent to allow flushing of exhaled carbon dioxide. The vent may allow gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the outside of the patient interface (e.g., into the environment).

[0081] Ventilation ports may include orifices through which gas can flow during the use of the mask. Many such vents are noisy. Others may become clogged during use and therefore provide insufficient flushing. Some vents may, for example, disturb the sleep of the patient's bed partner by causing noise or concentrated airflow.

[0082] ResMed has developed many improved mask ventilation technologies, see, for example, International Patent Application Publication No. WO 1998 / 034665; International Patent Application Publication No. WO 2000 / 078381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0083] The noise meter for the existing face mask (ISO 17510-2:2007, pressure of 10 cmH2O at 1 m)

[0084]

[0085] (*Only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0086] The sound pressure levels for each object are listed below.

[0087] Summary of the Invention

[0088] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use, and manufacturability.

[0089] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0090] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0091] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0092] One form of this technology includes a positioning and stabilizing structure configured to provide forces that hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes at least one band.

[0093] One form of this technology includes a patient interface comprising an inflation chamber, a sealing formation structure, and a positioning and stabilizing structure.

[0094] One form of this technology includes a patient interface comprising an inflatable chamber pressurizable to a therapeutic pressure at least 4 cmH2O above ambient air pressure. The inflatable chamber includes at least one inflatable chamber inlet port, sized and configured to receive an airflow at the therapeutic pressure for patient breathing. The patient interface also includes a sealing structure 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 openings therein, such that the airflow at the therapeutic pressure is 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 inflatable chamber throughout the patient's respiratory cycle in use. The patient interface also includes positioning and stabilizing structures to provide force to hold the sealing structure in a therapeutically effective position on the patient's head.

[0095] Another aspect of this technology is a series of modular elements that can be interconnected to form different types of patient interfaces.

[0096] In one form, each modular element has at least two versions or types. These versions or types can be used interchangeably to form different modular components.

[0097] One form of this technology includes a patient interface configured to deliver a breathable gas stream to a patient for the treatment of respiratory distress. The patient interface includes: an inflation chamber capable of being pressurized to a therapeutic pressure at least 4 cmH2O above ambient pressure throughout the patient's respiratory cycle during use; the inflation chamber including: a sealing-forming structure configured and arranged to seal with a region of the patient's face surrounding at least one inlet of the patient's airway; a positioning and stabilizing structure configured to maintain the sealing-forming structure in an appropriate position on the patient's face during use; and a forehead cooling system configured to cool the patient's forehead during use.

[0098] In an example of this technology, the patient interface can be configured to connect to an air circuit to receive the breathable gas flow from a flow generator.

[0099] In an example of this technology, the forehead cooling system can be configured to direct a portion of the breathable gas flow to the patient's forehead during use.

[0100] In an example of this technology, the forehead cooling system may be a catheter configured to direct a flow of breathable gas to the patient's forehead during use.

[0101] In an example of this technology, the catheter can be fluidly connected to the inflation chamber and can be configured to guide breathable gas from the inflation chamber toward the patient's forehead.

[0102] In an example of this technology, the catheter can be connected to an air circuit configured to connect to a connection port on the patient interface.

[0103] In an example of this technology, the conduit can be positioned within the positioning and stabilizing structure.

[0104] In an example of this technique, a first catheter may be fluidly connected to a first side of the patient’s eye in the region above the positioning and stabilizing structure.

[0105] In an example of this technique, the second catheter may be positioned on the second opposite side in the region above the patient's eye where the positioning and stabilizing structure is located.

[0106] In an example of this technology, the first catheter may be fluidly connected to the second catheter via a semi-permeable material configured to allow a breathable gas flow to exit to the patient's forehead.

[0107] In an example of this technology, the forehead cooling system can be positioned to contact the patient's forehead during use.

[0108] In an example of this technology, the forehead cooling system may include a fluid reservoir.

[0109] In examples of this technology, the fluid reservoir may include any one or more of the following: water, oil, gel, or sodium polyacrylate.

[0110] In an example of this technology, the patient interface may also include a pump configured to allow fluid to flow within the fluid reservoir.

[0111] In an example of this technology, the forehead cooling system may include a thermoelectric cooler.

[0112] In an example of this technology, the forehead cooling system may include a thermal interface material positioned to contact the patient's forehead during use.

[0113] In an example of this technology, the forehead cooling system may include a radiator.

[0114] Another aspect of this technology is a method for controlling a forehead cooling system, the method comprising the steps of: A) monitoring the temperature of a patient's forehead; B) activating a forehead cooler if the forehead temperature is higher than a first predetermined threshold; and C) deactivating the forehead cooler if the forehead temperature is lower than a second predetermined threshold.

[0115] In an example of this technique, the first predetermined threshold may be between 20 degrees Celsius and 30 degrees Celsius.

[0116] In an example of this technique, the first predetermined threshold can be substantially equal to 25 degrees Celsius.

[0117] In an example of this technique, the second predetermined threshold may be between 15 degrees Celsius and 20 degrees Celsius.

[0118] In an example of this technique, the second predetermined threshold can be substantially equal to 18 degrees Celsius.

[0119] In an example of this technology, the forehead cooler may include a first active mode and a second active mode, wherein the first active mode provides a first cooling rate and the second active mode provides a second cooling rate that is less than that of the first active mode.

[0120] In an example of this technology, the forehead cooling system can be configured to switch from the first active mode to the second active mode when the forehead temperature is below a third predetermined threshold, and to switch from the second active mode to the first active mode when the forehead temperature is above the third predetermined threshold.

[0121] In an example of this technique, the third predetermined threshold may be between 20 degrees and 22 degrees.

[0122] In an example of this technology, the forehead cooling system may be active only during the sleep-in period and inactive when the patient is detected to be asleep.

[0123] In an example of this technology, the forehead cooling system can be configured to increase the temperature of the patient's forehead as part of the wake-up process.

[0124] Another aspect of this technology is a patient interface configured to deliver a breathable gas stream to a patient for the treatment of respiratory distress. The patient interface includes: an inflation chamber capable of being pressurized to a therapeutic pressure at least 4 cmH2O above ambient pressure throughout the patient's respiratory cycle during use; the inflation chamber including: a sealing structure configured and arranged to seal with a region of the patient's face surrounding at least one inlet of the patient's airway; a positioning and stabilizing structure configured to maintain the sealing structure in an appropriate position on the patient's face during use; and a vent configured to expel gas from the inflation chamber into the environment.

[0125] The vent is fluidly connected to a catheter, such that the exhausted gas is guided through the catheter toward the patient's forehead area during use.

[0126] In the example, the catheter can be adjusted to the ventilation port to allow control over the amount and / or direction of gas expelled toward the patient's forehead area.

[0127] In the example, the patient interface may include a housing made of a material that is more rigid than the sealing structure, and the catheter is fluidly connected to the housing.

[0128] In this example, the conduit can be molded into the housing. In other examples, the conduit can be attached (such as detachably attached) to the housing.

[0129] In the example, the conduit can be connected to the sealing structure.

[0130] In the example, the ventilation port may include a central component and a housing, wherein the central component may rotate relative to the housing to regulate the flow directed toward the patient's forehead.

[0131] In another aspect of this technology, an air circuit is provided, configured to deliver a breathable gas flow to a patient interface for treating respiratory distress, the air circuit comprising:

[0132] An airway is configured to receive the breathable gas flow, the airway including a first end and a second end, the first end being configured to be connected to a flow generator and the second end being configured to be connected to the patient interface.

[0133] At least one ventilation port, the at least one ventilation port being configured to, in use, discharge at least a portion of the breathable gas stream and / or the patient's exhaled gas to the surrounding environment; and

[0134] At least one catheter is configured to direct the emitted gas toward the patient's forehead when in use.

[0135] In the example, the first end of the air duct may include a connector or connecting sleeve configured to facilitate connection of the air circuit to the flow generator.

[0136] In the example, the second end of the air duct may include a connector or connecting sleeve for facilitating the connection of the air circuit to the flow generator.

[0137] In this example, the second end of the airway may include a decoupling structure. For instance, the decoupling structure may have a patient interface side and an airway side.

[0138] In the example, the catheter can be connected to the patient interface side of the decoupling structure.

[0139] In the example, the air circuit may include one or more heating elements configured to heat the air in the air duct.

[0140] In the example, the heating element may be a heating wire circuit and may include one or more transducers, such as a temperature sensor.

[0141] In the example, the heating wire circuit can be spirally wound around the longitudinal axis of the air circuit.

[0142] According to another aspect of one form of the present technology, an airway is provided for use in a respiratory pressure therapy system configured to deliver a pressurized breathable gas flow to a patient's airway during use, wherein the airway is configured to pass at least a portion of the pressurized breathable gas out of the respiratory pressure therapy system, and wherein the airway is fluidly coupled to a catheter such that the portion of the pressurized breathable gas passing through the airway is directed toward the patient's forehead.

[0143] In the example, the vent can be configured to deliver at least a portion of the pressurized breathable gas from the inflation chamber of the patient interface to the surrounding environment.

[0144] In the example, the airway can be configured to deliver at least a portion of the patient’s exhaled air from the inflation chamber to the surrounding environment.

[0145] In the example, the airway can be adjustable to control the amount of pressurized breathable gas directed toward the patient's forehead.

[0146] In the example, the ventilation port may include a central component and a housing, wherein the central component may rotate relative to the housing to regulate the flow directed toward the patient's forehead.

[0147] In the example, the conduit can be attached to the vent.

[0148] According to another aspect of one form of the present technology, a forehead cooling system is provided, the forehead cooling system including a positioning and stabilizing structure configured to keep the forehead cooler in contact with the user's forehead.

[0149] In the example, the forehead cooler could be a thermoelectric cooler.

[0150] In the example, the forehead cooler could be a fluid cooler.

[0151] In the example, the forehead cooling system may also include a pump for circulating fluid through the forehead cooler. For example, the fluid may be a liquid or a gas.

[0152] In the example, the forehead cooler can be configured to direct airflow to the user's forehead.

[0153] In the example, the forehead cooling system may include one or more sensors configured to measure humidity, temperature, heart rate, or provide electroencephalogram (EEG) information about the user.

[0154] In the example, the forehead cooling system can be configured to actively cool the user's forehead to a pre-configured temperature.

[0155] In the example, the forehead cooling system can be configured to detect when the user falls asleep.

[0156] In the example, the forehead cooling system can be configured to reduce forehead cooling when sleep is detected.

[0157] In this example, the forehead cooling system can be configured to alert the user when it's time to wake up. For instance, the forehead cooling system can raise the temperature of the user's forehead when it's time to wake up.

[0158] According to another aspect of one form of the present technology, a method for controlling a forehead cooling system is provided, the method comprising the following steps:

[0159] A) Acquire patient information from one or more sensors;

[0160] B) Compare the acquired information with one or more predefined rules;

[0161] C) If the rule conditions are met, then the action is executed.

[0162] In the example, the method may also include the following step: determining whether the patient is awake or asleep.

[0163] In one example, the predefined rules could include whether the patient is awake and whether the forehead temperature is above, within, or below a predefined threshold. In other examples, the predefined rules could include whether the patient is asleep and whether the forehead cooling system should be deactivated, activated at low power, or configured to achieve a predefined sleep temperature range.

[0164] In the example, the actions performed include one or more of the following: controlling the temperature of the patient's forehead, generating auditory stimulation, changing the fluid flow rate within the cooling system, or starting or stopping the cooling system.

[0165] Another form of the technology includes a patient interface configured to deliver a breathable gas stream to a patient for the treatment of respiratory distress. The patient interface includes: an inflation chamber capable of being pressurized to a therapeutic pressure at least 4 cmH2O above ambient pressure throughout the patient's respiratory cycle during use; the inflation chamber including: a sealing-forming structure configured and arranged to seal with a region of the patient's face surrounding at least one inlet of the patient's airway; a positioning and stabilizing structure configured to maintain the sealing-forming structure in an appropriate position on the patient's face during use; a forehead cooling system configured to cool the patient's forehead during use; and a processor configured to detect the patient's sleep state, wherein the forehead cooling system is controlled based on the detected sleep state of the patient.

[0166] Another aspect of this technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0167] One aspect of this technology is a method for manufacturing equipment.

[0168] Another aspect of this technology is a method for assembling a modular system, including selecting positioning and stabilizing structures and connecting the positioning and stabilizing structures to a first liner or a second liner.

[0169] One aspect of this technology is that it is an easy-to-use medical device, for example, for use by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using this type of medical device.

[0170] One aspect of this technology is a portable RPT device that can be carried by a person, for example, in a person's home.

[0171] One aspect of this technology is a patient interface that can be cleaned at the patient's home, for example, in soapy water, without requiring specialized cleaning equipment. Another aspect of this technology is a humidifier water tank that can be cleaned at the patient's home, for example, in soapy water, without requiring specialized cleaning equipment.

[0172] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors such as 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.

[0173] Of course, some of these aspects can form sub-aspects of this technology. Furthermore, sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0174] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description

[0175] The technology is illustrated in the accompanying drawings by way of example and not limitation, and the same reference numerals in the drawings denote similar elements, including:

[0176] 4.1 Breathing Therapy System

[0177] Figure 1A A system including a patient 1000 wearing a patient interface 3000 in the form of a nose pillow, which 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 partner 1100 is also shown. The patient is sleeping in a supine position.

[0178] Figure 1BA system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask is shown, which 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.

[0179] Figure 1C A system including a patient 1000 wearing a full-face mask-like patient interface 3000 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 is sleeping in a side-lying position.

[0180] 4.2 Respiratory System and Facial Anatomy

[0181] 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.

[0182] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0183] Figure 2C It is a front view of the face with several marked surface anatomical features, including the upper lip, upper vermilion, lower vermilion, lower lip, mouth width, inner canthus, nasal alae, nasolabial groove, and corners of the mouth. It also indicates the directions of up, down, radially inward, and radially outward.

[0184] 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, subnasal septum, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, supraauricular point, and subauricular point. It also indicates the vertical and horizontal directions.

[0185] Figure 2E This is another side view of the head. It indicates the approximate location of the Frankfurt plane and the nasolabial angle. The coronal plane is also indicated.

[0186] 4.3 Patient Interface

[0187] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0188] Figure 3A-1 It shows the effect when in use. Figure 3A The force on the patient interface.

[0189] Figure 3Z A patient interface with a catheter tip cap, according to this technology, is shown.

[0190] Figure 3Z-1 It shows the effect of use in Figure 3Z The force on the patient interface.

[0191] 4.4RPT device

[0192] Figure 4A An RPT device of one form according to the present technology is shown.

[0193] Figure 4B 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.

[0194] 4.5 Humidifier

[0195] Figure 5A An isometric view of one form of humidifier according to the present technology is shown.

[0196] Figure 5B An isometric view of a humidifier according to the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0197] 4.6 Respiratory waveform

[0198] Figure 6A A typical breathing waveform model of a person sleeping is shown.

[0199] 4.7 Modularization

[0200] Figure 7A A perspective view of the padding of a patient interface is shown, which is configured to be worn by a patient and deliver pressurized air to the patient's nose and mouth.

[0201] Figure 7B A perspective view of the padding of a patient interface is shown, which is configured to be worn by a patient and deliver pressurized air to the patient's nose.

[0202] Figure 7C It shows that it can be used with Figure 7A padding or Figure 7B A perspective view of the tube used with the liner.

[0203] Figure 7D It shows that it can be used with Figure 7A pad or Figure 7B A perspective view of the hardener arm used with the pad.

[0204] Figure 7E It shows that it can be used with Figure 7A A perspective view of the headgear strap used with padding.

[0205] Figure 7F It shows that it can be used with Figure 7B A perspective view of the headgear strap used with padding.

[0206] Figure 7G It shows removable assembly to Figure 7C pipe or Figure 7D Front view of a pair of sleeves on the hardener arm.

[0207] Figure 7H It shows removable assembly to Figure 7D Front view of the complete sleeve on the hardener arm.

[0208] Figure 7I It shows removable assembly to Figure 7D A front perspective view of the complete sleeve in another alternative form of the hardener arm.

[0209] Figure 7J This is a front view of a patient wearing a patient interface with nose and mouth pads, positioned with the tube facing upwards.

[0210] Figure 7K This is a front view of a patient wearing a patient interface with nose and mouth pads, positioned with the tube facing downwards.

[0211] Figure 7L This is a front view of a patient wearing a patient interface with a nose pad and the tube facing upwards.

[0212] Figure 7M This is a front view of a patient wearing a patient interface with a nose pad and the tube facing downwards.

[0213] Figure 7N yes Figure 7L An independent perspective view of the vent.

[0214] Figure 7O yes Figure 7M A separate perspective view of a portion of the air circuit.

[0215] 4.8 Forehead Cooling

[0216] Figure 8A An example is shown, including a patient interface 3000 of a forehead cooling system 2000 and a positioning and stabilizing structure 3300.

[0217] Figure 8BA perspective view of an air circuit according to an example of this technology is shown.

[0218] Figure 8C A perspective view of an air circuit according to another example of this technology is shown.

[0219] Figure 9 A schematic diagram of a fluid-based forehead cooling system is shown.

[0220] Figure 10 An example of a respiratory therapy system including a forehead cooling system is shown.

[0221] Figure 11 An example of an active cooling system is shown in the form of a thermoelectric cooler and an interface for extracting heat from a fluid.

[0222] Figure 12A A block diagram of an air-assisted thermoelectric cooling system is shown.

[0223] Figure 12B An example of a combined PAP therapy system is shown, in which exhaust air is directed toward a forehead cooling system.

[0224] Figure 13 A cooling control state machine according to an example of this technology is shown.

[0225] Figure 14 A simultaneous heating and cooling system is shown, which is configured to heat or humidify the breathable gas supply for the patient and cool the patient's forehead.

[0226] Figure 15A An example of an air circuit configured to direct airflow to a patient's forehead is shown.

[0227] Figure 15B Another example of an air circuit configured to direct airflow to a patient's forehead is shown.

[0228] Figure 15C An example of the patient interface in use is shown, where the air circuit is configured to direct airflow to the patient's forehead.

[0229] Figure 16A An example of a padding module / patient interface is shown, which includes a catheter configured to direct airflow to the patient's forehead.

[0230] Figure 16B An example of a padding module / patient interface is shown, which includes an adjustable catheter configured to direct airflow to the patient's forehead.

[0231] Figure 16C It shows that according to Figure 16A Rear view of the padding module / patient interface.

[0232] Figure 17A A front view of a patient interface used with a forehead cooling system, according to an example of this technology, is shown.

[0233] Figure 17B A front view of a patient interface used with a forehead cooling system, according to another example of this technology, is shown.

[0234] Figure 17C A front view of a patient interface used with a forehead cooling system, according to another example of this technology, is shown.

[0235] Figure 18A A front view of a patient interface used with a ventilation port configured to direct airflow toward the patient's forehead is shown.

[0236] Figure 18B It shows Figure 18A A perspective view of the vent.

[0237] Figure 18C It shows Figure 18A A perspective view of the central component of the vent.

[0238] Figure 19A A side view of a patient interface according to another example of this technology is shown.

[0239] Figure 19B A side view of another patient interface according to another example of this technology is shown.

[0240] Figure 20A A perspective view of a patient interface according to an example of this technology is shown.

[0241] Figure 20B A perspective view of a forehead cooling system according to another example of this technology is shown.

[0242] Figure 20C A top view of a forehead cooling system according to another example of this technology is shown.

[0243] Figure 21A A side view of the VR device, including the patient interface, is shown.

[0244] Figure 21B It shows Figure 21A A cross-sectional view of the VR device taken along the sagittal plane of the patient.

[0245] Figure 22A This is an illustration of an example system that includes a computing device for monitoring sleep and providing insights and / or suggestions.

[0246] Figure 22B It is based on Figure 22A A diagram illustrating the components of an example computing device.

[0247] Figure 23 This is a flowchart illustrating a control method for automatic sleep detection and cooling control.

[0248] Figure 24 This is an example of a user interface used to receive feedback on sleep performance and / or control the operation of one or more forehead cooling systems. Detailed Implementation

[0249] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0250] The following description provides various examples of features and / or characteristics that may share one or more common 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 constitute another example.

[0251] 5.1 Therapy

[0252] In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the inlet of the airway of a patient 1000.

[0253] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0254] In some examples of this technology, mouth breathing is restricted, heavily constrained, or prevented.

[0255] 5.2 Respiratory Therapy System

[0256] 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 an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0257] 5.3 Patient Interface

[0258] According to one aspect of this technology, such as Figure 3AThe illustrated noninvasive patient interface 3000 includes the following functional aspects: a seal-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connecting 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 seal-forming structure 3100 is arranged to surround the inlet of the patient's airway to maintain positive pressure at the inlet of the patient's airway. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0259] like Figure 3Z As shown, a non-invasive patient interface 3000 according to another aspect of the present technology includes the following functional aspects: a sealing forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, and a connection for connecting to an air circuit (such as...). Figures 1A to 1C The air circuit 4170 shown is a connection port 3600 in one form. The air chamber 3200 may be formed by one or more modular components (e.g., a gasket module 3150 together with a sealing forming structure 3100), in which sense, the one or more modular components may be replaced by different components (e.g., components of different sizes).

[0260] 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.

[0261] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure higher than that of the ambient environment, for example, at least 2, 4, 6, 10 or 20 cmH2O relative to the ambient environment.

[0262] 5.3.1 Sealing Formation Structure

[0263] 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 the 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, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0264] In one embodiment, the target sealing area is located on the outer surface of the sealing structure 3100.

[0265] In some forms of this technology, the sealing structure 3100 is constructed from a biocompatible material (e.g., silicone rubber).

[0266] The sealing structure 3100 according to this technology can be constructed from a soft, flexible, elastic material (such as silicone).

[0267] In some forms of this technology, a system is provided that includes more than one sealing formation 3100, each of which is configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of sealing formation 3100 suitable for large-sized heads but not for small-sized heads, and another of the same sealing formation 3100 suitable for small-sized heads but not for large-sized heads.

[0268] 5.3.1.1 Sealing Mechanism

[0269] 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 acting on its bottom surface within the inflation chamber 3200, thereby forming a tight seal with the face. This pressure-assisted mechanism can work in conjunction with the elastic tension in the positioning and stabilizing structure.

[0270] 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 (e.g., about 0.25 mm to about 0.45 mm) that extends around the periphery of the inflation 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 inflation chamber 3200 and extends at least a portion of the path around the periphery. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from buckling during use.

[0271] In one form, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and arranged in a compressed state, for example as a result of elastic tension in the positioning and stabilizing structure.

[0272] In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by adjacent areas of the sealing flange.

[0273] In one form, the sealing structure includes an area having an adhesive or bonding surface.

[0274] In some forms of this technology, the sealing structure may include one or more of the following: a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having an adhesive or bonding surface.

[0275] 5.3.1.2 Nasal bridge or nasal ridge area

[0276] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the nasal midline or nasal ridge region of the patient's face during use.

[0277] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal when used on the nasal midline or nasal ridge region of a patient's face.

[0278] 5.3.1.3 Upper lip area

[0279] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face during use.

[0280] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip region of a patient's face during use.

[0281] 5.3.1.4 Chin area

[0282] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the chin area of ​​the patient's face during use.

[0283] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal when used on the chin area of ​​a patient's face.

[0284] 5.3.1.5 Forehead area

[0285] In one form, the sealing structure forms a seal on the forehead area of ​​the patient's face during use. In this form, the inflatable chamber can cover the eyes during use.

[0286] 5.3.1.6 Nasal pillow

[0287] In one form, 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.

[0288] A nasal pillow according to one aspect of the present invention 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. Additionally, the nasal pillow connection structure of the present invention 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 connection structure in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the structure connected to the handle.

[0289] 5.3.1.7 Nose mask only

[0290] In one embodiment, the patient interface 3000 includes a sealing structure 3100 configured to seal around the inlet of the patient's nasal airway rather than around the patient's mouth. The sealing structure 3100 may be configured to seal the upper portion of the patient's lips. The patient interface 3000 allows the patient's mouth to remain uncovered. This patient interface 3000 can deliver an air or breathable gas supply to both nostrils of the patient 1000 without delivering it to the mouth. This type of patient interface can be identified as a nasal mask only.

[0291] One form of the nasal mask according to this technology is conventionally recognized as a nasal mask, having a sealing formation structure 3100 configured to surround the nose on the patient's face and seal above the bridge of the nose. The nasal mask is typically triangular in shape. In one form, the non-invasive patient interface 3000 includes the sealing formation structure 3100, which, in use, forms a seal against the upper lip region (e.g., the upper lip), against at least a portion of the bridge of the nose above the nasal protuberance, and against the patient's face on each side of the nose, such as near the nasolabial folds. Figure 1B The patient interface 3000 shown has this type of sealing structure 3100. This patient interface 3000 can supply air or breathable gas to both nostrils of the patient 1000 through a single orifice.

[0292] Another form of nose mask can seal around the lower periphery of the patient's nose without engaging the nasal ridge. For example, this type of patient interface 3000 can be identified as a "nose pad" mask, and the sealing forming structure 3100 can be identified as a "nose pad". In one form, for example, as... Figure 3ZAs shown, the sealing forming structure 3100 is configured to form a seal with the lower nasal surface surrounding the nostrils during use. The sealing forming structure 3100 can be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including sealing to the lower and / or anterior surfaces of the nasal protuberance region of the patient's nose and sealing to the patient's nasal ala. The sealing forming structure 3100 may seal the upper part of the patient's lips. The shape of the sealing forming structure 3100 can be configured to match or closely follow the lower side of the patient's nose and may not contact the mid-nasal region of the patient's nose or any portion of the patient's nose beyond the nasal protuberance. In one form of nasal pad, the sealing forming structure 3100 includes a bridge portion that divides the opening into two orifices, each orifice supplying air or breathable gas to a corresponding patient nostril during use. The bridge portion can be configured to contact or seal the patient's columella during use. Alternatively, the sealing forming structure 3100 may include a single opening providing airflow or air or breathable gas to both patient nostrils.

[0293] In some forms, the nasal mask alone may include a nasal pillow as described above.

[0294] 5.3.1.8 Nose and mouth mask

[0295] In one embodiment, the patient interface 3000 includes a sealing structure 3100 configured to seal around an inlet to the patient's nasal airway and around the patient's mouth. The sealing structure 3100 may be configured to seal against the patient's face near the chin area. The patient interface 3000 can deliver an air or breathable gas supply to both nostrils and the mouth of the patient 1000. This type of patient interface can be identified as a nose and mouth mask.

[0296] One form of the nasomask according to the present technology is conventionally recognized as a full-face mask, having a sealing formation structure 3100 configured to seal around the nose, below the mouth, and above the middle of the nose on the patient's face. The nasomask is typically triangular in shape. In one form, the patient interface 3000 includes the sealing formation structure 3100, which, in use, forms a seal on the patient's chin area (which may include the patient's lower lip and / or the area directly below the lower lip), the middle of the patient's nose or at least a portion of the bridge of the nose above the nasal protuberance, and the cheek area of ​​the patient's face. Figure 1C The patient interface 3000 shown belongs to this type. This patient interface 3000 can supply air or breathable gas to the two nostrils and mouth of the patient 1000 through a single orifice. This type of sealing structure 3100 can be referred to as a nasal / mouth pad.

[0297] In another form, the patient interface 3000 includes a sealing formation structure 3100 that, in use, forms a seal on the patient's chin region (which may include the lower part of the patient's lip and / or the area directly below the lower part of the lip), on the lower and / or anterior surface of the nasal projection portion of the patient's nose, on each side of the patient's nose, such as near the nasolabial fold, on the alar of the patient's nose, and on the patient's face. The sealing formation structure 3100 may also form a seal against the upper part of the patient's lip. A patient interface 3000 having this type of sealing formation structure may have a single opening configured to deliver an airflow or breathable gas to the patient's two nostrils and mouth; may have an oral cavity configured to deliver air or breathable gas to the mouth and nasal orifices configured to deliver air or breathable gas to the nostrils; or may have an oral cavity for delivering air to the patient's mouth and two nasal orifices for delivering air to the corresponding nostrils. This type of patient interface 3000 can have a nose and a mouth, with the nose sealed to the patient's face in a position similar to a nose pad.

[0298] In another form of the nose and mouth mask, the patient interface 3000 may include a sealing formation 3100 having a nose including a nasal pillow and an mouth configured to form a seal around the patient's mouth against the patient's face.

[0299] In some forms, the sealing structure 3100 may have a nose portion that is separate from and distinct from the mouth. In other forms, the sealing structure 3100 may form a continuous seal around the patient's nose and mouth.

[0300] It should be understood that the above examples of different forms of patient interface 3000 do not constitute an exhaustive list of possible configurations. In some forms, patient interface 3000 may include combinations of different features of the above examples of nasal mask only and nasal and mouth mask.

[0301] 5.3.2 Inflation Chamber

[0302] The air chamber 3200 has a periphery whose shape is designed to complement the surface contour of the area on a normal person's face that will form a seal during use. During use, the boundary edges of the air chamber 3200 are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 may extend around the entire periphery of the air chamber 3200 during use. In some forms, the air chamber 3200 and the sealing structure 3100 are formed from a single sheet of homogeneous material.

[0303] In some forms of this technology, the air chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the air chamber. Such forms tend to be less noticeable and / or more comfortable for the wearer, which can improve adherence to therapy.

[0304] In some forms of this technology, the air chamber 3200 is made of a transparent material, such as transparent polycarbonate. Using a transparent material reduces the prominence of the patient interface and helps improve adherence to the therapy. The transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0305] In some forms of this technology, the air 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 adherence to the therapy.

[0306] In some forms, the air chamber 3200 is made of a rigid material such as polycarbonate. The rigid material can provide support for the seal-forming structure.

[0307] In some forms, the air chamber 3200 is made of a flexible material (e.g., a soft, flexible, elastic material such as silicone, textiles, foam, etc.). For example, in one example, it may be formed of a material with a Young's modulus of 0.4 GPa or lower, such as foam. In some forms of this technology, the air chamber 3200 may be made of a material with a Young's modulus of 0.1 GPa or lower, such as rubber. In other forms of this technology, the air chamber 3200 may be made of a material with a Young's modulus of 0.7 MPa or less, such as a material between 0.7 MPa and 0.3 MPa. An example of such a material is silicone.

[0308] 5.3.2.1.1 Nose and mouth mask

[0309] like Figure 7A As shown, the inflation chamber 3200-1 includes a pair of inflation chamber inlet ports 3254-1, which can be used to transfer gas into and / or out of the inflation chamber 3200-1. The inflation chamber inlet ports 3254-1 may be arranged on opposite sides of the inflation chamber 3200-1 (e.g., left and right sides).

[0310] In some forms, the air chamber 3200-1 may also include at least one vent opening 3402-1 (see example...) Figure 7A Ventilation opening 3402-1 is located at the center of inflation chamber 3200-1. For example, ventilation opening 3402-1 may be located between inlet ports 3254-1 of the inflation chamber.

[0311] In some forms, the inflation chamber 3200-1 may include a pair of recesses 3266-1. Each recess 3266-1 may be located near one of the inflation chamber inlet ports 3254-1. Each recess 3266-1 may form a partially recessed surface.

[0312] 5.3.2.1.2 Nose mask only

[0313] Only the air chamber 3200-2 of the nasal liner 3050-2 can be similar to the air chamber 3200-1 of the oronasal liner 3050-1. The following describes only some similarities and differences between the air chambers 3200-1 and 3200-2.

[0314] like Figure 7B As shown, the inflation chamber 3200-2 includes a pair of inflation chamber inlet ports 3254-2, which can be used to deliver gas into and / or out of the inflation chamber 3200-2. The inflation chamber inlet ports 3254-2 may be arranged on opposite sides of the inflation chamber 3200-2 (e.g., left and right sides).

[0315] In some forms, the air chamber 3200-2 may also include at least one vent opening 3402-2 (see example...) Figure 7B Ventilation opening 3402-2 is located at the center of inflation chamber 3200-2. For example, ventilation opening 3402-2 can be located between inlet ports 3254-2 of the inflation chamber.

[0316] In some forms, the inflation chamber 3200-2 may include a pair of recesses 3266-2. Each recess 3266-2 may be arranged near one of the inflation chamber inlet ports 3254-2. Each recess 3266-2 may form a partially recessed surface.

[0317] 5.3.3 Positioning and Stabilization Structure

[0318] The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by the positioning and stabilizing structure 3300. Since the positioning and stabilizing structure 3300 engages with the patient's head to hold the patient interface 3000 in a sealed position, the positioning and stabilizing structure 3300 may include and serve as a "headgear". Figure 3A and 3A-1 An example of a positioning and stabilizing structure is shown in the figure.

[0319] In one form, the positioning and stabilizing structure 3300 provides a holding force (i.e., F-inflation) sufficient to overcome the positive pressure effect in the inflation chamber 3200 to lift away from the face.

[0320] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the gravitational effects on the patient interface 3000.

[0321] Continue to refer to Figure 3A-1The positioning and stabilizing structure 3300 provides a force FPSS that helps maintain the inflatable chamber 3200 in a sealed position on the patient's face. The positioning and stabilizing force FPSS can be the resultant force of various forces from different elements of the positioning and stabilizing structure 3300. For example, the headband can individually provide a band force Fband to hold the sealing structure 3100 on the patient's face. The force Fband can also be directed at least partially upwards to overcome gravity Fg. Gravity Fg can be specifically illustrated with respect to the sealing structure 3100 and the inflatable chamber 3200, but gravity will act across the entire patient interface 3000 (i.e., in the same direction as the illustrated gravity Fg).

[0322] Gravity Fg can be opposite to frictional force Ff, which can act in the direction directly opposite to gravity Fg. When gravity pulls the sealing structure 3100 and the inflation chamber 3200 downwards (e.g.) Figure 3A-1 As shown), the frictional force Ff will act in an upward direction (e.g., against the patient's face). For example, the patient may experience the frictional force Ff on the upper part of their lips (and / or other surfaces of the patient's face that contact the seal-forming structure 3100) to counteract movement in a downward direction (which can help stabilize the pad in place). Although the frictional force Ff is specifically shown as relative to the gravity Fg of the seal-forming structure 3100 and the inflation chamber 3200, a component of the total frictional force (not shown) will also be relative to the gravity Fg associated with the positioning and stabilizing structure 3300 of the patient interface 3000 and any other part. The frictional force can act anywhere along the patient interface 3000 that contacts the patient's skin (or hair). The frictional force Ff extends in the opposite direction of gravity Fg and along the patient's skin (or hair). In some forms, gravity Fg may also be counteracted by the vertical component of the reaction force from the patient's face acting on the seal-forming structure 3100, for example, in the bridge of the nose and chin area of ​​the patient's face.

[0323] In some forms, the sum of the various forces can be equal to zero, so that the patient interface 3000 is in equilibrium (e.g., does not move along the patient's face during use). Specifically, gravity Fg and the inflation force Ff tend to move the seal-forming structure 3100 away from the desired sealing position. A positioning and stabilizing force FPSS is applied to counteract gravity Fg and inflation force Ff (as well as any frictional force Ff) and keep the seal-forming structure 3100 properly positioned. While the positioning and stabilizing force FPSS may exceed the sum of gravity Fg and inflation force Ff (where any additional positioning and stabilizing force FPSS is balanced by reaction forces from the patient's head acting on the various parts of the patient interface 3000) and still keep the seal-forming structure 3100 in the proper sealing position, patient comfort may be sacrificed. Maximum patient comfort can be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilizing force FPSS is just strong enough to achieve this. In some examples, the positioning and stabilizing structure 3300 can be adjustable such that, during assembly, the positioning and stabilizing force FPSS is greater than the force required to precisely balance the gravity Fg and the inflation force F, so that the patient interface 3000 remains sufficiently close to the patient's head, preventing destructive forces that may be experienced during use (such as tube resistance or lateral shunting of the inflation chamber 3200 during lateral decubitus position) from breaking the seal. As described below, when using the patient interface 3000, the various positions of the patient's head can be determined to achieve the positioning and stabilizing force FPSS necessary for balance.

[0324] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0325] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with how a patient wears the device while sleeping. In one example, the positioning and stabilization structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilization structure 3300 includes at least one strip with a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strip.

[0326] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying down in a supine sleeping position, wherein the back area of ​​the patient's head rests on a pillow.

[0327] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying on the pillow in a side-sleeping position with the side of the patient's head on the pillow.

[0328] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible or loose band. This decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, its presence prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0329] In one form of this technology, the positioning and stabilizing structure 3300 includes a band constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the band. In another form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0330] In some forms of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) band. For example, the band may be configured to be tensioned during use and guide forces to bring the sealing structure into sealed contact with a portion of the patient's face. In an example, the band may be configured as a tie.

[0331] In one form of this technology, the positioning and stabilizing structure includes a first frenulum, which is constructed and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the supraauricular point of the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0332] In one form of the technology applicable to nasal masks or full-face masks, the positioning and stabilizing structure includes a second strap that is configured and arranged such that, in use, at least a portion of the upper edge of the second strap passes below the subauricular point of the patient's head and covers or is located below the occipital bone of the patient's head.

[0333] In one form of the technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap that is configured and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.

[0334] In some forms of this technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. An advantage of this is that the strap is more comfortable for the patient when they are sleeping.

[0335] In some forms of this technology, the positioning and stabilizing structure 3300 includes a belt configured to be breathable to allow moisture to be transported through the belt.

[0336] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0337] 5.3.3.1 Catheter head cover

[0338] 5.3.3.1.1 Catheter head sheath

[0339] In some forms of this technology, the positioning and stabilizing structure 3300 includes one or more head tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example through the inflation chamber 3200 and the sealing forming structure 3100. Figure 3Z In the illustrated form of this technology, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the inflation chamber 3200. The tubes 3350 are configured to position and stabilize the sealing formation 3100 of the patient interface 3000 at an appropriate portion of the patient's face (e.g., nose and / or mouth) during use. This allows the conduit of the air circuit 4170, which provides pressurized airflow, to connect to a connection port 3600 of the patient interface, located at a position other than the front of the patient's face, such as at the top of the patient's head.

[0340] exist Figure 3Z In the illustrated form of this technology, the positioning and stabilizing structure 3300 includes two tubes 3350, each located on a different side of the patient's head during use, and extending above the corresponding ear (above the supraacus point on the patient's head) through the corresponding cheek area to a curved tube 3610 at the top of the patient's head. This form of the technology may be advantageous because if the patient is sleeping with their head on their side and one of the tubes 3350 is compressed to block or partially block the flow of gas along the tube 3350, the other tube 3350 remains open to supply pressurized gas to the patient. In other examples of this technology, the patient interface 3000 may include a different number of tubes, such as one tube, or two or more tubes.

[0341] In one example where the patient interface has a tube 3350, the single tube 3350 is positioned on one side of the patient's head during use (e.g., across a cheek area), and a band forming part of the positioning and stabilizing structure 3300 is positioned on the other side of the patient's head during use (e.g., across another area) to help secure the patient interface 3000 to the patient's head. For example, the tube 3350 and the band may each be under tension during use to help hold the sealing structure 3100 in a sealed position.

[0342] In one embodiment, the tube 3350 may be at least partially extendable, such that the tube 3350 and the band can be adjusted to substantially equal lengths when worn by a patient. This allows for substantially symmetrical adjustment between the tube 3350 and the band, such that the sealing structure remains substantially centered.

[0343] exist Figure 3Z In the illustrated embodiment, two tubes 3350 are fluidly connected to each other at their upper ends and to a connection port 3600. In some examples, the two tubes 3350 are formed integrally, while in other examples, the tubes 3350 are formed separately but are connected during use and can be disconnected, for example, for cleaning or storage. When using separate tubes, they can be indirectly connected together, for example, each tube can be connected to a T-connector. The T-connector can have two arms / branches, each of which can be fluidly connected to a corresponding tube in the tubes 3350. Additionally, the T-connector can have a third arm or opening that provides a connection port 3600 for fluid connection with the air circuit 4170 during use. This opening can be an inlet 3332 for receiving a pressurized airflow (see, for example, 7C).

[0344] In some forms, the third arm of a T-connector can be substantially perpendicular to each of the first two arms.

[0345] In some forms, the third arm of a T-connector can be formed at an angle relative to each of the first two arms.

[0346] In some configurations, a Y-shaped connector can be used instead of a T-shaped connector. The first two arms can be tilted relative to each other, and the third arm can be tilted relative to the first two arms. The angled formation of the first two arms can resemble the shape of the patient's head to conform to that shape.

[0347] In some forms, at least one arm of the T-connector (or Y-connector) can be flexible. This allows the connector to bend based on the shape of the patient's head and / or the forces in the positioning and stabilizing structure 3300.

[0348] In some forms, at least one arm of a T-connector (or Y-connector) may be at least partially rigid. This helps maintain the shape of the connector so that bending of the connector does not close the airflow path.

[0349] Tube 3350 may be formed of a flexible material, such as an elastomer, like silicone or TPE, and / or of one or more fabrics and / or foam materials. Tube 3350 may have a pre-shaped form and be able to bend or move into another shape when a force is applied, but return to the original pre-shaped form when the force is not applied. Tube 3350 may typically be arched or curved, its shape approximating the head contour between the top of the patient's head and the nasal or oral region.

[0350] In some examples, the one or more tubes 3350 are compression-resistant to prevent blockage during use if they are flattened, for example, if squeezed between a patient's head and a pillow, especially if there is only one tube 3350. The tube 3350 may be formed to have sufficient structural rigidity to resist flattening, or may be as described in U.S. Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0351] Each tube 3350 can be configured to receive an airflow from a connection port 3600 on the top of the patient's head and deliver that airflow to a sealing structure 3100 at the patient's airway inlet. Figure 3Z In the example shown, each tube 3350, in use, is located on a path extending from the inflation chamber 3200 through the patient's cheek region and above the patient's ear to the curved tube 3610. For example, the portion of each tube 3350 near the inflation chamber 3200 may cover the maxillary region of the patient's head in use. Another portion of each tube 3350 may cover the area of ​​the patient's head above the supraauricular basal point. Each tube 3350 may also be located on one or both of the patient's sphenoid and / or temporal bones, and the patient's frontal and parietal bones. The curved tube 3610, in use, may be located on the patient's parietal bone, frontal bone, and / or the junction between them (e.g., the coronal suture).

[0352] In some forms of this technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned within a range spanning the top of the patient's head, thus allowing the patient interface 3000 to be positioned for the comfort or fit of an individual patient. In some examples, the headgear 3350 is configured to allow movement of the upper portion of the patient interface 3000 (e.g., the connection port 3600) relative to the lower portion of the patient interface 3000 (e.g., the inflation chamber 3200). That is, the connection port 3600 can be at least partially separated from the inflation chamber 3200. Thus, the sealing structure 3100 can form an effective seal with the patient's face, regardless of the position of the connection port 3600 on the patient's head (at least within a predetermined range of positions).

[0353] As described above, in some examples of this technology, the patient interface 3000 includes a sealing-forming structure 3100 in the form of a pad, which is generally located below the nose and seals to the lower periphery of the nose (e.g., a subnasal pad). A positioning and stabilizing structure 3300, including a tube 3350, can be configured and arranged to pull the sealing-forming structure 3100 under the nose into the patient's face using a posterior-superior (e.g., posterosuperior) sealing force. The posterosuperior sealing force allows the sealing-forming structure 3100 to form a good seal against the lower periphery of the patient's nose and the forward-facing surfaces of the patient's face, such as on either side of the patient's nose and above the patient's lips.

[0354] Catheters forming part of the positioning and stabilizing structure 3300, such as headbands, can provide forces that contribute to the positioning and stabilizing force FPSS. For example... Figure 3Z-1 As shown, the positioning and stabilizing force FPSS can be the resultant force of various forces from different elements of the positioning and stabilizing structure 3300. For example, each catheter can provide a force F catheter guided in a posterior and correspondingly lateral direction to keep the sealing forming structure 3100 against the patient's face (entering the upper lip and sealing below the nose) and to counteract the positive pressure in the inflation chamber 3200 that lifts the face away (i.e., F inflation). The force F catheter can also be guided at least partially in an upward direction to overcome gravity Fg.

[0355] In some forms, when the catheter is filled with pressurized air, it can provide a force directed towards the patient's head. This force can help grip the patient's head. This force can be caused by the expansion of the catheter during normal use. In some forms, this force can provide cushioning for the patient's head. The catheter can be designed to limit expansion to prevent excessive clamping of the patient's head.

[0356] The position of the patient's head can also change the clamping force of the catheter. For example, if the patient is lying on their side, the weight of the patient's head can compress one catheter, while another catheter (e.g., on the side not between the patient's head and the sleeping surface, such as a pillow) can expand further in order to maintain substantially the same pressurized airflow rate.

[0357] Gravity Fg can be opposite to frictional force Ff, which can act in the direction directly opposite to gravity Fg. When gravity pulls the sealing structure 3100 and the inflation chamber 3200 downwards (e.g.) Figure 3A-1 As shown), the frictional force Ff will act in an upward direction (e.g., against the patient's face). For example, the patient may experience the frictional force Ff on the upper part of their lips (and / or other surfaces of the patient's face that contact the seal-forming structure 3100) to counteract movement in a downward direction (which can help stabilize the pad in place). Although the frictional force Ff is specifically shown relative to the gravity Fg of the seal-forming structure 3100 and the inflation chamber 3200, a component of the total frictional force (not shown) will also be relative to the gravity Fg associated with the positioning and stabilizing structure 3300 of the patient interface 3000 and any other part. The frictional force can act anywhere along the patient interface 3000 that contacts the patient's skin (or hair). The frictional force Ff extends in the opposite direction to gravity Fg and along the patient's skin (or hair).

[0358] In some forms, the sum of the various forces can be equal to zero, so that the patient interface 3000 is in equilibrium (e.g., does not move along the patient's face during use). Specifically, gravity Fg and the inflation force Ff tend to move the seal-forming structure 3100 away from the desired sealing position. A positioning and stabilizing force FPSS is applied to counteract gravity Fg and inflation force Ff (as well as any frictional force Ff) and keep the seal-forming structure 3100 properly positioned. While the positioning and stabilizing force FPSS may exceed the sum of gravity Fg and inflation force Ff (where any additional positioning and stabilizing force FPSS is balanced by reaction forces from the patient's head acting on the various parts of the patient interface 3000) and still keep the seal-forming structure 3100 in the proper sealing position, patient comfort may be sacrificed. Maximum patient comfort can be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilizing force FPSS is just strong enough to achieve this. In some examples, the positioning and stabilizing structure 3300 can be adjustable such that, upon assembly, the positioning and stabilizing force FPSS is greater than the force required to precisely balance the gravity Fg and the inflation force F to hold the patient interface 3000 sufficiently close against the patient's head so that destructive forces that may be experienced during use (such as tube resistance or lateral shunting of the inflation chamber 3200 during lateral recumbency) do not break the seal. As described below, various positions of the patient's head when using the patient interface 3000 can determine the positioning and stabilizing force FPSS required to achieve balance.

[0359] 5.3.3.1.2 Extendable and non-extendable pipe sections

[0360] In some examples of this technology, one or both tubes of tube 3350 are not extendable in length. However, in some forms, tube 3350 may include one or more extendable tube segments, such as segments formed by an extendable accordion-like structure. In some forms, patient interface 3000 may include positioning and stabilizing structure 3300, which includes at least one gas delivery tube comprising a tube wall having an extendable accordion-like structure. Figure 3Z The patient interface 3000 shown includes a tube 3350, the upper part of which includes extendable tube segments, each in the form of an extendable accordion structure 3362.

[0361] In some forms, the extendable accordion-like structure 3328 can be formed as a series of ridges and grooves on the surface of the tube 3350. The accordion-like structure 3328 can be biased toward a retracted position and can be moved to an extended position when the patient is prone and the positioning and stabilizing structure 3300 is in place. Because portions of the tube 3350 can be substantially non-extendable (e.g., a non-extendable tube segment 3363), the accordion-like structure 3328 allows the positioning and stabilizing structure 3300 to extend to accommodate different head sizes. This allows a single-size tube 3350 to be used with multiple head sizes. For example, as a result of the accordion-like structure 3328, the positioning and stabilizing structure 3300 can be “single-size fit”. Alternatively, the tube 3350 can be manufactured in multiple sizes (e.g., small, medium, large). The patient can select a length that most closely matches their head, and the accordion-like structure 3328 can be slightly adjusted to fit an individual patient.

[0362] In some configurations, inlet 3332 may be located in the middle of conduit 6320. For example, conduit 3350 may be symmetrical about inlet 3332 via at least one axis.

[0363] The cross-sectional shape of the non-extendable segment 3363 of tube 3350 can be circular, elliptical, oval, D-shaped, or rounded rectangular, as described, for example, in U.S. Patent No. 6,044,844. A cross-sectional shape that presents a flat surface on the side of the tube facing and contacting other parts of the patient's face or head can be more comfortable to wear than a tube with, for example, a circular cross-section.

[0364] In some examples of this technology, the non-extendable tube segment 3363 connects to the inflation chamber 3200 at a low angle. The headgear tube 3350 may extend downward to the side of the patient's head and then bend forward and inward to connect to the inflation chamber 3200 in front of the patient's face. Before connecting to the inflation chamber 3200, the tube 3350 may extend to a position at the same vertical position as the connection to the inflation chamber 3200 (or, in some examples, below it). That is, before connecting to the inflation chamber 3200, the tube 3350 may protrude in at least a partially upward direction. A portion of the tube 3350 may be located below the inflation chamber 3200 and / or the sealing forming structure 3100. The tube 3350 may contact the patient's face below the cheekbone, which is more comfortable than contacting the patient's cheekbone and avoids excessively obscuring the patient's peripheral vision.

[0365] 5.3.3.1.3 Catheter head connection port

[0366] In some forms of this technology, the patient interface 3000 may include a connection port 3600 located near the upper, side, or rear portion of the patient's head. For example, in Figure 3Z In the illustrated form of the present technology, the connection port 3600 is located at the top of the patient's head (e.g., in a position relative to the patient's head). In this example, the patient interface 3000 includes a bend 3610 forming the connection port 3600. The bend 3610 may be configured to be in fluid connection with a conduit of the air circuit 4170. The bend 3610 may be configured to rotate relative to the positioning and stabilizing structure 3300 to at least partially disengage the conduit from the positioning and stabilizing structure 3300. In some examples, the bend 3610 may be configured to rotate by rotating about a substantially vertical axis, and in some specific examples, by rotating about two or more axes. In some examples, the bend may include a tube 3350 or be connected to a tube 3350 via a ball-and-socket joint. The connection portion 3600 may be located in the sagittal plane of the patient's head during use.

[0367] Patient interfaces with a connection port not located in front of the patient's face may be advantageous, as some patients may find catheters connected to patient interfaces in front of the patient's face unsightly and / or not prominent. For example, a catheter connected to a patient interface in front of the patient's face may easily disturb bedding or sheets, especially if the catheter extends downward from the patient interface during use. Forms of this technology that include patient interfaces with a connection port positioned above the patient's head during use can make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: a side-lying position, a supine position (e.g., on their back, generally up), or a prone position (e.g., on their front, generally down). Furthermore, connecting the catheter to the front of the patient interface exacerbates a problem known as tube resistance, where the catheter exerts undesirable forces on the patient interface during head or catheter movement, resulting in displacement away from the face. Tube resistance may be less of a problem when the force is received at the upper part of the patient's head than at the front of the patient's face, closer to the sealing structure (where tube drag forces are more likely to disrupt the seal).

[0368] 5.3.3.1.4 Fluid Connection of Head Sleeve

[0369] Two tubes 3350 are fluidly connected at their lower ends to an inflation chamber 3200. In some forms of this technology, the connection between the tubes 3350 and the inflation chamber 3200 is achieved through the connection of two rigid connectors. The tubes 3350 and the inflation chamber 3200 can be configured to allow the patient to easily and reliably connect the two components together. The tubes 3350 and the inflation chamber 3200 can be configured to provide tactile and / or auditory feedback in the form of a reassuring click or similar sound, allowing the patient to easily know that each tube 3350 has been correctly connected to the inflation chamber 3200. In one form, the tubes 3350 are formed of silicone or textile material, and the lower end of each silicone tube 3350 is overmolded to a rigid connector made of, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector on each tube 3350 may include a concave mating feature configured to engage with a convex mating feature on the inflation chamber 3200. Alternatively, the rigid connector on each tube 3350 may include a convex mating feature configured to connect to a concave mating feature on the inflation chamber 3200. In other examples, each tube 3350 may include a convex or concave connector formed of a flexible material (e.g., silicone or TPE), such as the same material formed of the tube 3350.

[0370] In other examples, compression seals are used to connect each tube 3350 to the inflation chamber 3200. For example, a resilient, flexible (e.g., silicone) tube 3350 without a rigid connector can be configured to be compressed to reduce its diameter, allowing it to be compressed into a port in the inflation chamber 3200, and the inherent elasticity of the silicone pushes the tube 3350 outward, thereby sealing the tube 3350 in the port in an airtight manner. Alternatively, in a hard-on-hard engagement between the tube 3350 and the inflation chamber 3200, each tube 3350 and / or the inflation chamber 3200 may include a pressure-activated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange can be pressed against the engagement between the tube and the circumferential surface of the port or connector surrounding the inflation chamber 3200 to form or reinforce a seal between the tube 3350 and the inflation chamber 3200.

[0371] 5.3.3.2 Headgear

[0372] In some forms, the positioning and stabilizing structure 3300 may include a headgear 3302 with at least one strap, which may be worn by the patient to assist in properly aligning the sealing structure 3100 relative to the patient's face (e.g., to limit or prevent leakage).

[0373] As described above, some forms of the headgear 3302 can be made of textile materials that can comfortably conform to the patient's skin. The fabric can be flexible to conform to various facial contours. Although the fabric may include a hardener along a selected length, it can limit the bending, flexing, and / or stretching of the headgear 3302.

[0374] In some forms, the hood 3302 may be at least partially stretchable. For example, the hood 3302 may comprise an elastic or similar stretchable material. For example, the entire hood 3302 may be stretchable, or selected portions may be stretchable (or more stretchable than the surrounding portions). This allows the hood 3302 to stretch under tension, which may help provide a sealing force for the seal-forming structure 3100.

[0375] The two types of hoods, the four-point hood 3302-1 and the two-point hood 3302-2, are discussed in more detail below as illustrative examples.

[0376] 5.3.3.2.1 Four-point connection

[0377] like Figure 7E As shown, some forms of the headgear 3302-1 can be a four-point connection headgear. This means that the headgear 3302-1 can be attached to four separate locations on the inflation chamber 3200, to the frame of the inflation chamber 3200, and / or to the arm of the inflation chamber 3200. The headgear 3302-1 may include four different straps that provide tension to help hold the sealing formation 3100 in the sealed position. Figure 3A The positioning and stabilizing structure of the 3300 can also be considered as a four-point connection headgear.

[0378] In some forms, the headgear 3302-1 may include a lower band 3304-1, which may be attached to the lower part of the padding 3050-1. The lower band 3304-1 may extend along the patient's cheek toward the back of the patient's head. For example, the lower band 3304-1 may cover the masseter muscle on either side of the patient's face. Therefore, the lower band 3304-1 may contact the patient's head below the ear. The lower band 3304-1 may meet at the back of the patient's head and may cover the occipital bone and / or trapezius muscle.

[0379] The headgear 3302-1 may also include an upper band 3305-1 that may cover the temporal bone, parietal bone, and / or occipital bone. The upper band 3305-1 may also be connected to the tube 3350 (e.g., by engaging with the flap 3320).

[0380] The posterior strap 3307-1 can extend between the upper strap 3305-1 and the lower strap 3304-1. The lower strap 3304-1 and upper strap 3305-1 on a given side (e.g., left or right) can also be connected adjacent to each other to the posterior strap 3307-1. Therefore, the height of the posterior strap 3307-1 can be approximated as the combined height of the lower strap 3304-1 and the upper strap 3305-1. In use, the posterior strap 3307-1 can cover the occipital and / or parietal bones. This allows the posterior strap 3307-1 to help anchor the headgear 3302-1 to the patient's head.

[0381] In the example shown, the headband 3302-1 can be formed into a generally X shape. The lower band 3304-1 and the upper band 3305-1 can be attached to the rear band 3307-1 by stitching, ultrasonic welding or any similar process.

[0382] In some configurations, the lower band 3304-1 is connected to the magnetic member 3306-1. For example, each lower band 3304-1 may pass through the magnetic member 3306-1, thereby allowing adjustment of the length of each lower band 3304-1. The magnetic member 3306-1 may be removably connected to the magnet 3370-1 (described below), such that the lower band 3304-1 can be disconnected from the inflation chamber 3200, but the length of the lower band 3304-1 may remain unaffected.

[0383] In some configurations, the top band 3305-1 can be directly connected to the tab 3320 of the tube 3350. The top band 3305-1 can pass through the tab 3320 to adjust the length and control the tension of each top band 3305-1.

[0384] In some forms, the headgear 3302-1 can be used only with the nose and mouth pads 3050-1 (e.g., because the nose pad 3050-1 alone does not have four connection points). However, the headgear 3302-1 can be used interchangeably with the tube 3350 and the hardener arm 3340.

[0385] 5.3.3.2.2 Two-point connection

[0386] like Figure 7F As shown, some forms of the headgear 3302-2 can be two-point connected headgears. This means that the headgear 3302-2 can be connected to two separate locations.

[0387] In some forms, the headgear 3302-2 may be formed from a continuous sheet of material. In other words, the headgear 3302-2 may not be formed from multiple straps connected (e.g., sewn) together. This may be comfortable for the patient, as they will not come into contact with any seams or joints connecting the different straps. In other forms, the headgear 3302-2 may be formed from multiple straps (e.g., two upper straps, a back strap, etc.) connected together (e.g., by sewing, ultrasonic welding, etc.).

[0388] In some forms of this technology, the positioning and stabilizing structure 3300 includes at least one headband that, in addition to the tube 3350, is used to position and stabilize the sealing forming structure 3100 at the patient's airway inlet. For example... Figure 3Z As shown, the patient interface 3000 includes a strap 3307-2 forming part of a positioning and stabilizing structure 3300. For example, the strap 3307-2 may be referred to as a back strap or a hood strap. The hood strap 3307-2 may cover the temporal bone, parietal bone, and / or occipital bone. In other examples of the present technology, one or more additional straps may be provided. For example, an example of a patient interface 3000 with a nose and mouth pad according to the present technology may have a second lower strap configured to abut against the patient's head near the patient's neck and / or against the posterior surface of the patient's neck.

[0389] exist Figure 3Z In the example shown, the band 3310 of the positioning and stabilizing structure 3300 is connected between two tubes 3350 located on each side of the patient's head and passing around the back of the patient's head, for example, covering or lying beneath the occipital bone of the patient's head during use. The band 3310 is connected to each tube above the patient's ear. (See reference...) Figure 3Z The positioning and stabilizing structure 3300 includes a pair of tabs 3320. In use, a strap 3310 can be attached between the tabs 3320. The strap 3310 can be flexible enough to wrap around the back of the patient's head and rest comfortably against the patient's head, even under tension during use.

[0390] like Figure 7F As shown, some forms of the headgear 3302-2 can be at least partially bifurcated. For example, the rear band 3307-2 of the headgear 3302-2 (e.g., configured to contact the back of the patient's head) can be wider than the surrounding portion of the headgear 3302-2. The middle section 3308-2 of the rear band 3307-2 may include a slit 3309-2. Thus, due to the slit 3309-2, the upper section of the rear band 3307-2 can move relative to the lower section. This can allow for greater band coverage over the back area of ​​the patient's head, which can help to better anchor the headgear 3302-2 to the patient's head, since there is no lower band (e.g., 3304-1).

[0391] In some configurations, the headgear 3302-2 can be used only with the nose pad 3050-2 (e.g., because the nose and mouth pads 3050-1 do not have four connection points). However, the headgear 3302-2 can be used interchangeably with the tube 3350 and the hardener arm 3340.

[0392] 5.3.3.3 Hardener Arm

[0393] like Figure 7DAs shown, the hardening arm 3340 may be an elongated, rigid member that helps hold the pad (e.g., nose and mouth pad 3050-1 or nose pad 3050-2) in the operating position. The hardening arm 3340 may contact one side of the patient's head and provide force to limit the sliding of the seal-forming structure 3100 from the patient's nose and / or mouth.

[0394] In some forms, the hardening arm 3340 is made of a rigid material (e.g., plastic). A rigid material may not allow the hardening arm 3340 to stretch. Additionally, the hardening arm 3340 may be inflexible and may be non-flexible. The hardening arm 3340 may be pre-molded into a desired shape to fit the patient's head. For example, the hardening arm 3340 may be molded into a curved shape to substantially correspond to the shape of the side of the patient's head (e.g., covering the masseter muscle and / or temporal bone).

[0395] In some forms, the hardener arm 3340 can be molded to fit a specific patient's head (e.g., a custom hardener arm 3340).

[0396] In some forms, the hardening arm 3340 may be flexible in at least one direction. For example, the hardening arm 3340 may be flexible in its width but inflexible in its length. In other words, the hardening arm 3340 may bend about an axis along its width, but not about an axis perpendicular to its length. This allows individual patients to adjust the hardening arm 3340 to better fit their individual head.

[0397] In some configurations, the hardening arm 3340 can remain in its new position after bending. This allows patients to adjust the shape of the hardening arm 3340 to suit their specific head shape, and then the hardening arm 3340 will maintain the desired shape during use to improve patient comfort.

[0398] In some forms, the first end 3342 of the hardening arm 3340 may be a free end, while the second end 3344 of the hardening arm 3340 (e.g., opposite the first end 3342) may be fixed. The first end 3342 may be curved to minimize sharp edges that could cause patient discomfort. In use, the first end 3342 may also cover the patient's head adjacent to the temporal bone. The second end 3344 may be fixed to the arm connection structure 3504.

[0399] In some forms, the arm connection structure 3504 may resemble the conduit connection structure 3500. For example, the arm connection structure 3504 and the conduit connection structure 3500 may have substantially the same shape. This allows the conduit connection structure 3500 or the arm connection structure 3504 to fit into a recess (e.g., 3266-1 or 3266-2) and connect to the inflation chamber inlet port 3254. The arm connection structure 3504 may connect to the nose and mouth pad 3050-1 or the nose pad 3050-2 in substantially the same manner as the conduit connection structure 3500 (e.g., via snap-fit, press-fit, friction fit, etc.).

[0400] In some forms, the arm connection structure 3504 can be used as a plug for the inflation chamber inlet port 3254 (e.g., 3254-1 and / or 3254-2). Unlike the tube 3350, the hardener arm 3340 does not deliver pressurized air to the inflation chamber 3200. The hardener arm 3340 can be used in a "tube-down" configuration, where the hose is connected to and delivers air to the inflation chamber 3200 through the vent opening 3402 (e.g., 3402-1 and / or 3402-2). In this example, air does not need to travel into or out of the inflation chamber inlet opening 3254. Therefore, the arm connection structure 3504 can form a seal with the inflation chamber inlet opening 3254 to restrict airflow into or out of the inflation chamber 3200.

[0401] 5.3.4 Vent

[0402] In one embodiment, the patient interface 3000 includes a ventilation port 3400 that is configured and arranged to allow flushing of exhaled gases (e.g., carbon dioxide).

[0403] In some configurations, the ventilation port 3400 is configured to allow continuous airflow from the interior of the inflation chamber 3200 to the environment, while the pressure within the inflation chamber is positive relative to the environment. The ventilation port 3400 is configured such that the airflow rate is sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining therapeutic pressure within the inflation chamber during use.

[0404] One form of the vent 3400 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.

[0405] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a decoupling structure (e.g., a rotation).

[0406] like Figure 7NAs shown, the ventilation port 3450 can be used with the patient interface 3000. The ventilation port 3450 may have a shape substantially similar to that of the ventilation opening 3402-1 (e.g., a substantially circular shape).

[0407] The vent 3450 can be connected to the mouth and nose inflation chamber 3200-1 (e.g., in...). Figure 7A (as shown in the diagram) or only the nasal inflation chamber 3200-2 (e.g., in...) Figure 7B (As shown in the image) used together.

[0408] See also Figure 7A The vent 3450 may include a vent housing 3404, which may be configured to engage with the vent opening 3402. The vent housing 3404 may be made of a rigid or semi-rigid material. For example, the vent housing 3404 may be made of plastic, metal, or any similar material. The vent housing 3404 may increase the rigidity of the patient interface 3000 (e.g., to limit undesirable bending that could affect the position of the seal-forming structure 3100 on the patient's face).

[0409] The ventilation housing 3404 may include a front surface 3408, a rear surface 3412, and a sidewall / recess 3416. The front surface 3408 faces away from the patient's face during use and may be positioned outside the pressurized volume of the inflation chamber 3200. The rear surface 3412 is arranged opposite the front surface 3408. During use, the rear surface 3412 may face the patient and may be positioned within the pressurized volume of the inflation chamber 3200. A recess or sidewall 3416 may be formed between the front surface 3408 and the rear surface 3412. A portion of the inflation chamber 3200 may be received within the recess / sidewall 3416 to hold the airway 3400 in place.

[0410] In some configurations, the diffuser 3448 can be used in conjunction with the ventilation housing 3404. The diffuser 3448 can help limit the decibel output from any patient interface 3000 (or any other patient interface). Specifically, the diffuser 3448 can help limit the decibel level associated with air output (e.g., exhaled air) from the patient interface 3000, although the diffuser 3448 can limit the decibel level at any point within the patient interface.

[0411] In some configurations, the diffuser 3448 can diffuse out of the inflation chamber 3200 and through the vent of the vent housing 3404, thus slowing it down. The diffuser 3448 can help avoid spraying and associated discomfort to the patient and / or bed partner (e.g., noise caused by spraying onto pillows, sheets, bedding, etc.).

[0412] In some forms, the diffuser may include a central component 3456 having an outer surface that faces away from the patient during use. The outer diameter of the central component 3456 may be smaller than the inner diameter of the vent housing 3404 adjacent to the front surface 3408. This can create a gap 3464 through which air can travel.

[0413] 5.3.5 Decoupling Structure

[0414] In one form, the patient interface 3000 includes at least one decoupling structure to allow at least a portion of the patient interface to move relative to another portion of the patient interface. For example, the decoupling structure may be configured to separate the connection port from the sealing formation structure. In some examples, the decoupling structure may be a swivel or a ball and socket.

[0415] 5.3.6 Connection Port

[0416] Connection port 3600 allows connection to air circuit 4170.

[0417] 5.3.7 Forehead Support

[0418] In one embodiment, the patient interface 3000 includes a forehead support 3700.

[0419] 5.3.8 Anti-suffocation valve

[0420] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0421] Port 5.3.9

[0422] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0423] 5.3.10 Modularization

[0424] As mentioned above, the pads, headgear, and sleeves can be of different types, which can correspond to different uses (e.g., mouth breathing, nose breathing, etc.). Patients or clinicians can choose certain combinations of pads, headgear, and sleeves to optimize the effectiveness of the therapy and / or the comfort of the individual patient. An example of such a modular design is described in PCT / SG2022 / 050777, filed on 28 October 2022, the entire contents of which are incorporated herein by reference.

[0425] In some forms, different types of pads, caps, and sleeves can be used interchangeably to form different combinations of patient interfaces. This can be advantageous from a manufacturing perspective, as more types of patient interfaces can be created using fewer parts. Additionally or alternatively, various combinations can allow patients to change the type of patient interface without altering each component. This modular design is described in more detail below and in Singapore Patent Application No. 10202112048R, the entire contents of which are incorporated herein by reference.

[0426] Air can be delivered to the patient in one of two primary ways. In one example, the patient can receive a pressurized airflow through a head cannula 3350 (see, for example, see...). Figure 3Z This can be referred to as a "tube-up" configuration, and the connection port can be positioned at the top of the patient's head. In another example, the patient can receive a flow of pressurized air through a catheter connected to the inflation chamber 3200, for example, through connection port 3600 (see example). Figure 3A This can be referred to as a "tube-down" configuration, where the airflow duct is positioned in front of the patient's face. Different patients may be more comfortable with one type of air delivery than another (e.g., due to the patient's sleep type). Therefore, it may be beneficial to allow the use of a single type of patient interface in either a "tube-up" or "tube-down" configuration.

[0427] The patient interface can be part of a modular component with various interchangeable parts, which patients and / or clinicians can swap out for one or more components of different types. The following description illustrates the various combinations that can be produced by assembling the different parts together.

[0428] 5.3.10.1 Sleeve

[0429] In some configurations, to achieve modularity, the sleeve can be used with the tube 3350 and / or the hardener arm 3340. The sleeve can at least partially surround the tube 3350 and / or the hardener arm 3340. For example... Figures 7G to 7I As shown, sleeves of different shapes can be used, corresponding to different types of positioning and stabilizing structures 3300. In some forms, the sleeve can be configured to fit a specific patient's face. For example, the sleeve can be configured in a relatively posterior region of the patient's head.

[0430] In some forms, the sleeve can be made of comfort materials. For example, the sleeve can be made of textile materials, foam materials, or a combination of both. Comfort materials can come into contact with the patient during use and can feel soft against the patient's skin in order to improve patient compliance.

[0431] The material can also be flexible to facilitate putting on or taking off the sleeve from the tube 3350 or the hardener arm 3340. For example, the material may allow the sleeve to bend to conform to the shape of the tube or catheter head cap 3350 or the hardener arm 3340, which can be modified according to the shape of an individual patient's head.

[0432] In some forms, the sleeve may also be at least partially elastic (e.g., the material may allow the sleeve to stretch). The elastic material can help the sleeve stretch to fit around the tube 3350 or hardener arm 3340. The elastic material can then return to its initial position, which is in close contact with the tube 3350 or hardener arm 3340, to limit sleeve slippage during use.

[0433] As described in more detail below, some forms of sleeves can be specifically designed for hardening elements (e.g., tube 3350 and / or hardener arm 3340). However, these sleeves can facilitate interchangeable connection of these hardening elements with versions or types of pads (e.g., mouth and nose pad 3050-1, nose pad only 3050-2, etc.).

[0434] 5.3.10.1.1 Catheter sleeve

[0435] like Figure 7G As shown, one example of a sleeve is a conduit sleeve 3351, which can be used with the tube 3350 described above.

[0436] like Figure 7G As shown, the catheter sleeve 3351 may include... Figure 7C The tube 3350 shown has a similar curved shape. The flexible material used to construct the catheter sleeve 3351 allows the catheter sleeve 3351 to be further bent to correspond to the shape of the tube 3350 (e.g., when worn by a patient).

[0437] In some forms, the catheter sleeve 3351 may include a first or upper opening 3352. The upper opening 3352 may be disposed at one end of the catheter sleeve 3351. The upper opening 3352 may be an opening of a channel extending along at least a portion of the catheter sleeve 3351.

[0438] like Figure 7G As shown, some forms of the catheter sleeve 3351 may also include a lower extension 3354. The lower extension 3354 may be positioned on the end of the catheter sleeve 3351 opposite to the upper opening 3352. The catheter sleeve 3351 may be customized to fit a particular user's face. For example, the lower extension 3354 of the catheter sleeve 3351 may be configured in a relatively posterior or anterior region of the patient's head.

[0439] Some forms of the lower extension 3354 may include a rigid or semi-rigid member (e.g., within the sleeve 3351). The rigid or semi-rigid member may be made of a plastic material or a similar material. Alternatively, the lower extension 3354 may be hardened using a manufacturing process (e.g., stitching hardened threads, plain knitting, using a thicker material).

[0440] like Figure 7G As shown, some forms of the lower extension 3354 may include a connecting member 3356. In the example shown, the connecting member 3356 may be a magnet, although in other examples, the connecting member 3356 may be different types of connectors (e.g., mechanical fasteners, adhesives, hook and ring materials, etc.). The connecting member 3356 may also be positioned at one end of the lower extension 3354, although the connecting member 3356 may also be positioned anywhere along the lower extension 3354.

[0441] In some forms, the connecting member 3356 (e.g., a magnet) can be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the conduit sleeve 3351 is connected to the tube 3350 (see example...) Figure 7J When connected to the lower band 3304-1, the magnet 3370-1 can be removably connected to the connecting member 3356 to provide tension.

[0442] 5.3.10.1.2 Four-point arm sleeve

[0443] like Figure 7H As shown, another example of a sleeve is the four-point arm sleeve 3380, which can be used with the hardener arm 3340 described above.

[0444] like Figure 7H As shown, the four-point arm sleeve 3380 may include similar components. Figure 7D The curvature arm 3340 is shown in a curved shape. The flexible material used to construct the four-point arm sleeve 3380 allows the four-point arm sleeve 3380 to be further bent to correspond to the shape of the curvature arm 3340 (e.g., when worn by a patient and / or bent by a patient).

[0445] like Figure 7H As shown, some forms of the four-point arm sleeve 3380 may include a lower extension 3384. The lower extension 3384 may be located at one end of the four-point arm sleeve 3380.

[0446] In the example shown, the shape and / or structure of the lower extension 3384 is substantially the same as that of the lower extension 3354. For example, the lower extension 3384 may be more rigid than the rest of the four-point arm sleeve 3380 (e.g., due to rigidification of the thread or rigid material).

[0447] like Figure 7HAs shown, some forms of the lower extension 3384 may include a connecting member 3386. In the example shown, the connecting member 3386 may be a magnet, although in other examples, the connecting member 3386 may be different types of connectors (e.g., mechanical fasteners, adhesives, hook and ring materials, etc.). The connecting member 3386 may also be positioned at one end of the lower extension 3384, although the connecting member 3386 may also be positioned anywhere along the lower extension 3384.

[0448] In some forms, the connecting member 3386 (e.g., a magnet) can be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the four-point arm sleeve 3380 is connected to the hardener arm 3340 (see example...) Figure 7K When connected to the lower band 3304-1, the magnet 3370-1 can be removably connected to the connecting member 3386 to provide tension.

[0449] like Figure 7H As shown, the four-point arm sleeve 3380 may include a pair of tabs 3394, which may be similar to the tabs 3320 on the tube 3350. When a patient wears the four-point arm sleeve 3380, the tabs 3394 may be positioned on the patient's head at a position substantially the same as the position of the tabs 3320 when the patient wears the tube 3350.

[0450] 5.3.10.1.3 Two-point arm sleeve

[0451] like Figure 7I As shown, another example of a sleeve is the two-point arm sleeve 3380-1, which can be used with the hardener arm 3340 described above.

[0452] In some forms, the two-point arm sleeve 3380-1 can be similar to the four-point arm sleeve 3380 described above. Only some similarities and differences are described below.

[0453] like Figure 7I As shown, the two-point arm sleeve 3380-1 may include a lower opening 3388-1 located at one end of the two-point arm sleeve 3380-1. The lower opening 3388-1 may form an opening for a channel through the two-point arm sleeve 3380-1. In the example shown, the lower opening 3388-1 may lead to a surface of the conduit sleeve 3380-1.

[0454] like Figure 7I As shown, the two-point arm sleeve 3380-1 may include a pair of tabs 3394-1, which may be similar to the tab 3320 on the tube 3350. When a patient wears the two-point arm sleeve 3380-1, the tabs 3394-1 may be positioned on the patient's head at a position substantially the same as the position of the tab 3320 when the patient wears the tube 3350.

[0455] 5.3.10.2 Assembled Patient Interface

[0456] like Figures 7J to 7M As shown, the various components described above can be combined to form four different patient interfaces. Different patient interfaces allow patients to use different types based on their individual comfort levels. The modularity of the different components (e.g., the ability to use multiple types of patient interfaces) simplifies manufacturing and / or allows patients to switch more easily between multiple types of patient interfaces.

[0457] 5.3.10.2.1 Nose and mouth mask tubes configured upwards

[0458] like Figure 7J As shown, the patient can wear padding 3050-1 in a tube-up configuration having tube 3350 and four-point headgear 3302-1. This assembly forms a tube-up nose and mouth patient interface 3000-1.

[0459] In some configurations, the catheter sleeve can be used with tube 3350 to allow the patient to experience a "tube-up" air delivery type with mouth and nose pad 3050-1. As described below, the catheter sleeve provides additional connection points for attaching the four-point headgear 3302-1. However, other types of connectors besides the catheter sleeve may be used.

[0460] In the example shown, the conduit sleeve can be connected to the tube 3350 of the positioning and stabilizing structure 3300. The tube 3350 (via the conduit connection structure 3500) can be used to connect the tube 3350 to the gasket 3050-1. The conduit sleeve provides a magnet for connection to the magnet 3370-1 of the four-point sleeve 3302-1 (see, for example, [link to example]). Figure 7E Alternatively, different connection methods can be used.

[0461] like Figure 7J As shown, the four-point headgear 3302-1 can be connected in four separate positions to provide tension for holding the pad-1 in a sealed position on the patient's head.

[0462] For example, the lower band 3304-1 (e.g., via magnetic member 3306-1) can be removably attached to a magnet on the catheter sleeve. In use, each lower band 3304-1 can contact the patient's cheek (e.g., covering the masseter muscle). The lower band 3304-1 can also extend below the patient's ear.

[0463] 5.3.10.2.2 Nose and mouth mask tubes configured downwards

[0464] like Figure 7KAs shown, the patient can wear the pad 3050-1 in a tube-down configuration with a hardening arm 3340 and a four-point headgear 3302-1. This assembly forms a tube-down nose and mouth patient interface 3000-2.

[0465] In some configurations, the catheter sleeve can be used with the sclerotherapy arm 3340 to allow the patient to experience a “tube-down” air delivery mode with the mouth and nose pad 3050-1. As described below, the catheter sleeve provides additional connection points for attaching the four-point headgear 3302-1. However, other types of connectors besides the catheter sleeve may be used.

[0466] In the example shown, the conduit sleeve can be connected to the hardener arm 3340 of the positioning and stabilizing structure 3300. The hardener arm 3340 (via the conduit connection structure 3504) can be used to connect the hardener arm 3340 to the liner 3050-1. The conduit sleeve provides a magnet for connection to the magnet 3370-1 of the four-point head sleeve 3302-1 (see, for example, [link to example]). Figure 7E Alternatively, different connection methods can be used.

[0467] like Figure 7K As shown, the four-point headgear 3302-1 can be connected in four separate positions to provide tension for holding the pad 3050-1 in a sealed position on the patient's head.

[0468] For example, the lower band 3304-1 (e.g., via magnetic member 3306-1) can be removably attached to a magnet on the catheter sleeve. In use, each lower band 3304-1 can contact the patient's cheek (e.g., covering the masseter muscle). The lower band 3304-1 can also extend below the patient's ear.

[0469] 5.3.10.2.3 The nasal mask tube is configured upwards.

[0470] like Figure 7L As shown, the patient can wear the pad 3050-2 in the tube-up configuration with the tube 3350 and the two-point headgear 3302-2. This assembly forms a tube-up nasal-only patient interface 3000-3.

[0471] The catheter sleeve can be used with the tube 3350 and can provide additional comfort to the patient. The sleeve can be used to connect the positioning and stabilizing structure 3300 to the liner 3050-2 without adding an additional connection point. In the example shown, the tube 3350 of the positioning and stabilizing structure 3300 can be directly connected to the liner 3050-2.

[0472] like Figure 7LAs shown, the two-point headgear 3302-2 can be attached to the tab 3320 on the tube 3350 to provide tension in a sealed position that holds the pad 3050-2 on the patient's head.

[0473] 5.3.10.2.4 Nasal mask tube configured downwards

[0474] like Figure 7M As shown, the patient can wear a tube-upward-configured pad 3050-2 with a hardening arm 3340 and a two-point headgear 3302-2. This assembly forms a tube-downward-facing nasal patient interface 3000-4.

[0475] The catheter sleeve can be used with the sclerosing arm 3340 and can provide additional patient comfort. The sleeve can be used to attach the positioning and stabilizing structure 3300 to the liner 3050-2 without adding additional connection points. In the example shown, the sclerosing arm 3340 of the positioning and stabilizing structure 3300 can be directly attached to the liner 3050-2.

[0476] like Figure 7M As shown, the two-point headgear 3302-2 can be attached to the tab 3320 on the sleeve to provide tension in a sealed position that holds the pad 3050-2 on the patient's head.

[0477] 5.3.10.2.5 Component Modularization

[0478] Figure 7P This illustrates how different components can be combined to form the four different patient interfaces described above. As shown, different parts can be reused for different types of patient interfaces. This allows for easier manufacturing and assembly because a large number of the same parts can be produced and used in multiple types. The only part not used in multiple types could be a sleeve. However, sleeves are easier to manufacture. Figure 7O A portion of an air circuit 4170 that can be connected to a patient interface is shown, while Figure 7N This demonstrates interchangeable replacements based on the type of patient interface. Figure 7O The air vent 3404 of the air circuit shown.

[0479] 5.4RPT device

[0480] An RPT device 4000 according to one aspect of the present technology includes mechanical components, pneumatic components, and / or electrical components, and is configured to perform one or more algorithms 4300, such as any of the methods described herein in whole or in part. 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.

[0481] 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 4 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0482] 5.5 Air Circuit

[0483] According to one aspect of the present technology, the air circuit 4170 is a conduit or tube (described herein as an air duct) that is constructed and arranged to allow airflow between two components (such as the RPT device 4000 and the patient interface 3000 or 3800) during use.

[0484] Specifically, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface, for example, via a connection port 3600 connected to the patient interface. In some examples, the air circuit may include a connecting sleeve or connector for facilitating connection of the air circuit to the RPT device 4000 or flow generator and the patient interface. For example, the first end of the catheter / air tube may include a connector or connecting sleeve configured to facilitate connection of the air circuit to the flow generator, and the second end of the catheter / air tube may include a connector or connecting sleeve for facilitating connection of the air circuit to the flow generator.

[0485] In some examples, the air circuit may include a decoupling structure, such as a swivel or ball joint, to allow one part of the air circuit to omnidirectionally rotate or rotate relative to another part of the air circuit.

[0486] This air circuit can be referred to as an air delivery tube. In some cases, there may be separate branches in the circuit for inhalation and exhalation. In other cases, a single branch is used.

[0487] 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 element 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 element may be connected to a controller for its control. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, the entire contents of which are incorporated herein by reference.

[0488] 5.6 Humidifier

[0489] 5.6.1 Overview of Humidifiers

[0490] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 5A As shown), it is used to change the absolute humidity of the air or gas intended to be delivered to the patient relative to the ambient air. Typically, a humidifier 5000 is used to increase the absolute humidity of the airflow (relative to the ambient air) and raise the temperature of the airflow before it is delivered to the patient's airway.

[0491] 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 5A and Figure 5B 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 accommodate the humidifier reservoir 5110 and includes a heating element 5240.

[0492] 5.7 Respiratory waveform

[0493] Figure 6A A typical breathing waveform model of a sleeping person is shown. The horizontal axis represents time, and the vertical axis represents respiratory flow. Although parameter values ​​can vary, typical breathing may have the following approximations: tidal volume Vt 0.5 L, inspiratory time Ti 1.6 s, peak inspiratory flow rate Qpeak 0.4 L / s, expiratory time Te 2.4 s, and peak expiratory flow rate Qpeak -0.5 L / s. The total duration of breathing, Ttot, is approximately 4 s. A person typically breathes at a rate of approximately 15 breaths per minute (BPM), with a tidal volume Vent of approximately 7.5 L / min. The typical duty cycle (the ratio of Ti to Ttot) is approximately 40%.

[0494] 5.8 Forehead cooling

[0495] Patients with OSA are more likely to suffer from comorbid insomnia than the general population. It has been shown that forehead cooling can shorten the time it takes for insomnia patients to fall asleep. Therefore, one aspect of this technology is to provide a forehead cooling system 2000 configured to reduce the temperature of a patient's forehead during use.

[0496] In some examples, the forehead cooling system 2000 may be incorporated into a system for treating sleep-disordered breathing and / or insomnia. For example, the forehead cooling system may be incorporated into or configured to be attached to the patient interface 3000, the positioning and stabilization structure 3300 of the patient interface 3000, and / or configured to deliver a breathable gas flow to the air circuit 4170 of the patient interface 3000.

[0497] In some examples of the technology discussed herein, these forehead cooling systems may use, for example, an airflow from the RPT device 4000 or exhaled air from the patient's airway as a means of cooling the patient's forehead. For example, the airflow may be directed to or flow across the surface of the patient's forehead to remove heat from the patient's forehead, for example, by using convection.

[0498] In the example of using a humidifier 5000 in this technology, the airflow can be humidified to further help lower the temperature of the patient's forehead.

[0499] In other examples of this technology, a liquid forehead cooling system 2000 may be provided. These systems are configured to facilitate heat transfer to the patient's forehead, for example, by using conductive cooling.

[0500] In yet another example of this technology, an active forehead cooling system 2000 can be provided, for example, by using a Peltier cooler.

[0501] In one example of this technology, the system may include components such as heat exchangers, evaporative coolers, or active components such as Peltier coolers. Examples of heat exchangers and / or humidity exchangers that can be used with this technology are described in PCT Publication WO / 2013 / 067592, the entire contents of which are incorporated herein by reference.

[0502] It should be understood that any one or more of these techniques may be used independently or in combination to provide forehead cooling in the examples described herein.

[0503] While this technique is primarily described as an adjunct treatment for insomnia, it is believed to also be beneficial in the adjunctive treatment of other disorders, such as difficulty breathing, menopausal symptoms, high blood pressure, anxiety, hyperthyroidism, anhidrosis, diabetes, migraines, and chronic pain. In other examples, this technique may provide benefits in terms of sleep comfort, such as during pregnancy and the luteal phase of the menstrual cycle.

[0504] 5.8.1 Forehead Cooling Technology

[0505] 5.8.1.1 Air Cooling

[0506] refer to Figure 8A The patient interface 3000 is equipped with a forehead cooling system 2000. The forehead cooling system 2000 is connected to and supported by a positioning and stabilizing structure 3300. For example, the forehead cooling system may include a first end 2002 and a second end 2004, the first end being connected to and supported by a first side 4171 of the positioning and stabilizing structure 3300, and the second end being connected to and supported by a second side 4172 of the positioning and stabilizing structure 3300.

[0507] In the illustrated example, the forehead cooling system 2000 is connected to the positioning and stabilizing structure 3300 at a location above the patient's eyes to minimize any potential obstruction to the patient's field of vision. The forehead cooling system 2000 is also positioned such that a gap 2006 exists between the connection port 3600 on the top of the patient's head and the forehead cooling system 2000, which advantageously allows the patient's hair to extend through the gap, thereby potentially improving comfort and reducing irritation.

[0508] The forehead cooling system 2000 can be positioned and attached to a positioning and stabilizing structure using any suitable method, such as mounting to one or more belts as described herein.

[0509] The forehead cooling system 2000 can be configured to be attached (e.g., detachably attached) to the positioning and stabilizing structure 3300 using one or more fasteners such as snap-fit, buckle, or hook-and-loop fasteners. In some examples, the forehead cooling system 2000 may be detachably attached to one side of the positioning and stabilizing structure 3300 and non-detachably attached to the other side. In other examples of the art, the forehead cooling system may be non-removably engaged with the positioning and stabilizing structure 3300.

[0510] In some examples, the forehead cooling system 2000 may be attached to the positioning and stabilizing structure 3300 using an adjustment mechanism (such as a hook-and-loop fastener or a buckle (not shown)) to allow the patient to adjust the force applied to the patient's forehead during use. Additionally, the forehead cooling system may include a stretchable material, such as an elastic material or spandex, to allow the forehead cooling system 2000 to remain in contact with the patient's forehead in a range of sleeping positions.

[0511] In some examples, the forehead cooling system 2000 can be configured to be fluidly connected to the patient interface 3000 or the air circuit 4170. For example, airflow through the patient interface 3000 and / or the air circuit 4170 can be used to cool the patient's forehead during use as described herein. Figure 8A In one example, the forehead cooling system 2000 may be fluidly connected to a first side 4171 and / or a second side 4172 of the positioning and stabilizing structure 3300, such that airflow received through the connection port 3600 passes through the forehead cooling system 2000 or otherwise generates airflow within the forehead cooling system 2000 (e.g., by using the Venturi effect) to remove heat from the patient's forehead region.

[0512] For example, the forehead cooling system 2000 can be fluidly connected at a first end 2002 to a first side 4171 of the positioning and stabilizing structure 3000, such that airflow from the connection port 3600 to the patient interface is fluidly coupled to the forehead cooling system 2000. The second end 2004 can be configured (e.g., using the Venturi effect) to draw in air from the ambient environment. This can advantageously draw in cooler and / or drier air than can be provided by the RPT device 4000, especially when using a heated / humidified air supply or air circuit 4170. To prevent air from escaping from the second end 2004, a one-way valve that allows air to be drawn in but not to be expelled can be used. Examples of suitable valves will be familiar to those skilled in the art.

[0513] For example, Figure 8B A cross-sectional view of a forehead cooling system 2000 in the form of a fluid conduit 8005 is shown, which can be fluidly coupled to a patient interface 3000 and / or an RPT device 4000. For example, as described herein, the positioning and stabilization structure 3300 may include a conduit cap through which a pressurized breathable gas flow is provided during use. For example, the pressurized breathable gas flow generated by the RPT device 4000 may be directed through the fluid conduit of the forehead cooling system 2000 to cool the patient's forehead during use.

[0514] In one example, the fluid conduit 8005 may include or be entirely composed of fabric. An example of a fabric conduit is described in more detail in PCT Publication WO2012167327A1, published on 13 December 2012, the entire contents of which are incorporated herein by reference.

[0515] The use of fabrics can effectively improve patient comfort and, consequently, increase adherence to respiratory therapy.

[0516] In one example of this technology, the flow of breathable gas through the forehead cooling system 2000 may be sufficient to cool the patient's forehead area, for example, through convection cooling. In some examples of this technology, the material used in the fluid conduit 8005 may be selected to include at least one material having a relatively high thermal conductivity (such as greater than 0.5 W / mK). For example, the fluid conduit may include thermally conductive silicone (such as carbon-impregnated silicone) or one or more metals (such as fine flexible metal wires or metal layers).

[0517] In some examples of this technology, the fluid conduit 8005 may include a semi-permeable material configured to discharge an airflow received from the connection port 3600 to the patient's forehead to cool the forehead. For example, the fluid conduit 8005 material may be configured to allow a certain amount of breathable gas flow through the conduit and to the patient's forehead region. For example, the fluid conduit 8005 may be configured to allow airflow to pass through. For example, the fluid conduit 8005 may include one or more orifices 8007 configured to allow a breathable gas flow to pass through them. By using the orifices 8007, airflow can be directed to specific areas of the forehead to better control the location and rate of cooling (e.g., by controlling the number and size of the orifices). For example, the fluid conduit 8005 may have between 3 and 100 orifices 8007 arranged along the length of the fluid conduit 8005, such as approximately between 10 and 50 orifices 8007.

[0518] In other examples, the fluid conduit 8005 may be made of a breathable material that allows some airflow to pass through it. For example, the fluid conduit 8005 may be made of fabric and may provide airflow between the gaps between the fibers or yarns of the fabric, and / or the fibers or yarns may allow some airflow to pass through it.

[0519] In other examples of this technology, the forehead cooling system 2000 can be configured to maintain contact with the patient's forehead and remove heat from the forehead by transferring forehead heat into an airflow, subsequently delivering heated air to the patient's airway for breathing. As will be appreciated by those skilled in the art, heating the breathable gas / airflow before the patient inhales can improve comfort and compliance with the respiratory pressure therapy system.

[0520] exist Figure 8C In one example shown, a forehead cooling system 2000 is provided, which includes a conduit 8005 having a patient contact layer 8009 configured to contact the patient's forehead during use and to absorb heat from the patient's forehead during use. For example, this patient contact layer 8009 may be made of a thermally conductive material as described herein.

[0521] In some examples of the technology described herein, the patient contact layer 8009 may be a thermoelectric cooler 5005.

[0522] Attached to the patient contact layer is a fluid conduit 8005 configured to receive a fluid flow, such as a breathable gas flow. In some examples, the fluid flow is a liquid, such as water, and in other examples, the fluid flow can be a breathable gas, such as air / oxygen. This fluid flow can advantageously be used to draw heat away from the patient contact layer and thus cool the patient's forehead.

[0523] In some examples, the patient contact layer 8009 may form one wall of the fluid conduit 8005; in other examples, such as Figure 8C As shown, the patient contact layer 8009 can be attached to an interface layer 8011 located between the patient contact layer 8009 and the fluid flow 'F' through the fluid conduit 8005. For example, it is preferable to manufacture the fluid conduit 8005 separately from the patient contact layer 8009 and attach the fluid conduit 8005 to the patient contact layer using one or more fasteners (such as adhesives). In this example, the interface layer 8011 acts as one of the walls of the fluid conduit 8005. The interface layer 8011 can be further configured to be more porous (i.e., having more pores or larger pore sizes 8007) or have higher thermal conductivity than other materials (such as fabric materials) used in the fluid conduit 8005. In some examples described herein, this interface layer 8011 can be as follows: Figure 12A The thermal interface material 6002 is described in more detail.

[0524] In some examples of this technology, monitoring and / or controlling the temperature of the forehead cooling system 2000 and / or the patient's forehead may be advantageous. Therefore, in some examples of this technology, the forehead cooling system 2000 may include one or more sensors 8013, such as a temperature sensor, humidity sensor, heart rate sensor, or EEG sensor. These sensors 8013 may be used to provide information about the effectiveness of the forehead cooling system 2000, or otherwise to provide feedback on whether forehead cooling is needed. It should be understood that these sensors 8013 may be coupled to a processor, such as via a wired or wireless connection. For example, the processor may be located in an RPT 4000 or a personal computing device, such as a smartphone or computer. Further examples of monitoring systems are described herein.

[0525] 5.8.1.2 Fluid Cooling

[0526] exist Figure 9 In one example of the present technology shown, a forehead cooling system 2000 is provided, which includes a fluid delivery system 3001 configured to transfer heat away from the forehead of a patient 1000, for example, using thermal conduction. While the system is shown schematically for simplification, it should be understood that the system can be attached to or otherwise mounted to the patient interface 3000, such as to the positioning and stabilization structure 3300 as described herein.

[0527] The fluid transfer system 3001 may include a reservoir 3002, such as a bladder, configured to receive a volume of fluid, such as water, oil, or air, during use. The reservoir 3002 may include an inlet 3004 configured to receive a fluid flow and an outlet 3006 configured to transfer the fluid from the reservoir via a pump 3008, for example, for cooling or recirculation.

[0528] In some examples of this technology, pump 3008 may be a peristaltic pump or any other suitable fluid pump; for example, if the fluid is air, pump 3008 may be a blower. In some examples of this technology, the blower may be a blower included in an RPT device 4000 configured to produce a breathable airflow into a patient's airway for the treatment of sleep apnea.

[0529] In some examples of this technology, the reservoir 3002 may be flexible to allow it to conform to the patient's forehead, i.e., a flexible fluid capsule, such as a plastic capsule made of a flexible material such as polyvinyl chloride or thermoplastic polyurethane. In other examples, the reservoir may be configured to be connected via, for example, later. Figure 12A The thermal interface material 6002 discussed is thermally connected to the patient's forehead.

[0530] In some examples of this technology, the reservoir 3002 may contain a gel 3010 material, such as one or more gel beads. For example, the gel may include sodium polyacrylate or any other suitable gel. The use of a gel can advantageously improve the heat transfer characteristics of the forehead cooling system 2000, for example, by providing a higher thermal conductivity than using a fluid such as oil or water alone, or by increasing the heat capacity of the heat transfer medium (relative to using oil or water alone).

[0531] In some examples of this technology (such as examples where the forehead cooling system is removable), the reservoir 3002 can be cooled in a refrigerator before use to quickly lower the temperature and thus aid sleep. Therefore, one aspect of this technology is to provide a forehead cooling system 2000 that can be removed from the positioning and stabilization structure 3300 and cooled before use to assist sleep.

[0532] In some examples of this technology, the reservoir 3002 may contain a phase change material (PCM), such as sodium acetate trihydrate. In use, the PCM can be heated to a liquid state, and during use, it can be triggered by a bending process or by pressing a metal plate inside the reservoir, causing the PCM to change from its liquid state to a solid state, thereby producing a cooling effect. Then, by reheating the liquid to change the PCM from solid to liquid, the PCM material can be prepared for the next sleep period. It should be understood that in examples of PCM material used in this technology, a pump 3008 is not required, and the forehead cooling system 2000 may simply consist of a reservoir of PCM material held in place on the patient's forehead.

[0533] Figure 10 It shows Figure 9 An example of a forehead cooling technique that engages with the forehead of patient 1000. In this example, a reservoir 3002 is supported to engage with the forehead of patient 1000 using a positioning and stabilizing structure 3300. For example, the reservoir may be attached to one or more straps or catheters on each side of the patient's head.

[0534] Therefore, by combining the forehead cooling system 2000 with the patient interface, the positioning and stabilizing structure 3300 can be used to position and stabilize the patient interface for engagement with the patient's face. Similarly, patients with comorbid insomnia and sleep apnea can be treated simultaneously in one system.

[0535] 5.8.1.3 Thermoelectric cooling

[0536] Figure 11 An example of the present technology is shown, wherein a radiator 5000 is provided to transfer heat between fluid within a forehead cooling system 2000 and ambient air. In one example, a radiator 5006 is mounted to a fluid conduit 5002 to transfer or dissipate heat from the fluid conduit to the surrounding environment. As in the previous example, the fluid conduit may also include an inlet 3004 and an outlet 3006, which may be connected to a pump 3008 or a blower for fluid circulation.

[0537] In some examples of this technology, a thermoelectric cooler 5005, such as a Peltier cooler, can be provided. The thermoelectric cooler 5005 allows for simultaneous heating and cooling. When a voltage is applied to the cooler 5005, the temperature of the first side 5005A decreases, while the temperature of the second side 5005B increases. The heating and cooling sides of the thermoelectric cooler can be switched by applying voltages of opposite polarities.

[0538] In one example of this technology, the thermoelectric cooler 5005 may have a first side 5005A and a second side 5005B, the first side being configured to engage a fluid conduit 5002 in use to cool the fluid conduit 5002, and the second side being configured to contact ambient air, or in some cases attached to a radiator 5006 in fluid communication with ambient air, in order to dissipate heat from the thermoelectric cooler.

[0539] In some examples, a fan or another blower may also be provided to improve air circulation in any one or more of the fluid conduit 5002, thermoelectric cooler 5005, and / or radiator 5006. For example, the fan or blower may be an axial fan, a radial fan, or a piezoelectric blower. In some examples, the blower may be provided by the RPT device 4000; for example, air circulation may be provided by airflow drawn into the RPT device 4000, for example, from an inlet. In other examples, the airflow may be provided by air exhausted through a vent 3450 or other similar structure, such as an anti-suffocation valve.

[0540] exist Figure 11 In the illustrated example, the fluid conduit 5002 can be configured to extend from the inlet 3004 or outlet 3006 as described herein to provide an increased surface area for heat transfer. For example, the fluid conduit 5002 may have a substantially rectangular central portion 5008, sized to accommodate a thermoelectric cooler 5005. Between the substantially rectangular central portion 5008 and the inlet 3004 or outlet 3006, the fluid conduit may include a gently tapered section 5010 to minimize or reduce fluid turbulence within the fluid conduit 5002.

[0541] In other examples of this technology, the radiator 5006 and / or the thermoelectric cooler 5005 may be configured to be directly mounted to the reservoir or mounted to the patient’s forehead when in use, as shown in Figure 8.

[0542] exist Figure 12A In some examples, the thermoelectric cooler 5005 is configured to be thermally connected to the patient's forehead via a thermal interface material 6002. For example, the thermal interface material 6002 may be a gel or elastomer, such as biocompatible silicone. The use of a gel or elastomer can advantageously increase the rate at which heat is transferred from the patient's forehead to the reservoir or thermoelectric cooler 5005. In some examples, the thermal interface material may further act as a cushioning element that can at least partially conform to the shape of the patient's head, thereby enhancing patient comfort.

[0543] On the opposite side of the thermoelectric cooler 5005 is a heat sink, which is optionally connected to the thermoelectric cooler 5005 via another thermal interface material 6002. It should be understood that the thermal interface material 6002 used for the heat sink does not need to have the same comfort and biocompatibility requirements as thermal interface materials used in patient contact. For example, the thermal interface material may include a metal oxide.

[0544] 5.8.1.4 Air-assisted heat dissipation

[0545] In some embodiments, airflow may be directed toward the patient's forehead. For example, this airflow may be provided by exhaust air from the patient interface, air supplied from the RPT device 4000, or air already drawn into the RPT device, for example, via an air inlet. In other examples, thermal interface material 6002 may be positioned on the patient's forehead, and airflow (or a portion of the airflow) from the vent 3400 may be directed toward the outward (non-patient contact) surface of the thermal interface material 6002.

[0546] The thermal interface material 6002 can conduct heat from the forehead to the exhaust airflow and into the atmosphere. In some embodiments, the environmental side of the thermal interface material 6002 may include design features to increase the surface area exposed to the flow path, for example, the design features may take the form of ribs or fins in the material. Therefore, this thermal interface material 6002 can act as a heat sink.

[0547] In some embodiments, the thermally conductive material can be composed of a composite of different materials. For example, the thermally conductive material can be designed as a layered structure, such that the layer in contact with the forehead has different properties compared to the layer exposed to the atmosphere. In this way, the contact layer material can be specifically selected to be biocompatible with the forehead, and the properties of the material can be designed to be more comfortable; for example, the hardness of the material in contact with the forehead can be significantly lower than that of the other layers of the conductive material.

[0548] In some forms of this technology, it may be advantageous to allow fluid to flow across the surface of a radiator to further remove heat from the system. For example, the fluid may originate from a reservoir as described herein, or alternatively, when the additional cooling technology is used in combination with a PAP system, an airflow from the PAP system may be used to transfer heat away from the radiator.

[0549] For example, pressurized airflow from the RPT device 4000 can be configured to flow over the radiator to draw heat away from it, and thus from the patient's forehead. In other examples, air exhausted from the patient interface can be configured to draw heat away from the radiator, and thus from the patient's forehead. For example, see reference... Figure 12BThe patient interface 3000 can be configured to discharge air 'A' from the patient interface 3000 toward the patient's forehead, for example, by guiding an upward flow of exhaust air from the patient interface 3000 toward the patient's forehead. As described herein, the discharged air can be used to cool the forehead cooler 2000, such as a thermoelectric cooler 5005.

[0550] Similarly, refer to Figure 8A The forehead cooling system 2000 can be configured to draw air from any one or more air circuits of the air circuit 4170 for cooling the forehead and / or radiator described herein.

[0551] Therefore, one aspect of this technology is to use airflow from the vent in the patient interface 3000 to drive or assist the system, thereby providing forehead cooling to the patient.

[0552] The invention described in any of the previously described embodiments can also be adapted for use without PAP therapy by replacing the PAP airflow with any alternative source (such as a blower from an alternative fan) or an airflow from a compressed air source. In some embodiments, the flow rate can be controlled to control the amount of heat exchange. As with the previous embodiments, this can be used as a way to achieve a specific temperature profile over time, or as part of a control loop to achieve a specific physiological effect.

[0553] 5.8.1.5 Evaporative Cooling

[0554] In some embodiments, improved cooling performance can be achieved by employing the principle of evaporative cooling. In some embodiments, the conductive dielectric layer exposed to the airflow can be made of a porous or absorbent material, allowing the conductive dielectric layer to be soaked in water (or other fluid) before bedtime. When exposed to the airflow, the water can begin to evaporate, thus removing heat from the layer more quickly as the liquid molecules absorb energy during the transition from a liquid to a solid phase. In some embodiments, the system may be equipped with a reservoir to replenish the liquid as it evaporates. In some embodiments, a wicking material may be present, connecting the reservoir to the layer exposed to the atmospheric path, which can transport the liquid from the reservoir.

[0555] 5.8.2 Cooling Control

[0556] Figure 13 An example of a state machine for controlling a patient's forehead temperature is shown. In the illustrated example, the state machine is associated with a thermoelectric cooler 5005; however, this should not be considered limiting, as the logic for starting and stopping the thermoelectric cooler could alternatively be applied to control the flow of fluid or the expulsion of air toward the patient's forehead.

[0557] refer to Figure 13 When the RPT device 4000 is turned on, the thermoelectric cooler 5005 can be configured to switch from a closed state to an operational state, wherein in the closed state the thermoelectric cooler is inactive, and in the operational state the thermoelectric cooler is actively cooling the forehead of the patient 1000.

[0558] If the ambient temperature or the patient's forehead temperature drops below a predetermined set temperature (such as between 18 and 25 degrees Celsius, e.g., approximately 20 degrees Celsius), the thermoelectric cooler 5005 can be configured to shut off or otherwise become inactive until the ambient temperature or forehead temperature rises back above the predetermined set temperature. For example, the system may include a temperature sensor 8013 configured to provide a measurement of the temperature of the patient's forehead or a region adjacent to the patient's forehead.

[0559] In some examples, the thermoelectric cooler 5005 may be configured to have a second predetermined set temperature at which the operation of the thermoelectric cooler is reduced to provide a reduced cooling rate. For example, the second predetermined set temperature may be between approximately 20 degrees Celsius and 22 degrees Celsius, such that the thermoelectric cooler 5005 operates at a reduced rate between the first predetermined set temperature and the second predetermined set temperature. When the temperature is above the second predetermined set temperature, the thermoelectric cooler 5005 may be configured to operate in a normal, full-power mode.

[0560] The patient's forehead temperature can typically be between 33 and 37 degrees Celsius, and this technology can be configured to reduce the forehead temperature to a few degrees Celsius, such as 14 to 18 degrees Celsius, or more preferably about 14 or 15 degrees Celsius.

[0561] In some examples of this technique, reducing the forehead temperature to 14 to 18 degrees Celsius may not be practical. This could be due to thermodynamic constraints of the cooling method used, or limitations in power, noise, size, or cost. Therefore, reducing the forehead temperature to below body temperature (including, for example, temperatures of approximately 20 to 30 degrees Celsius) may be advantageous.

[0562] In one example, this technique is configured to lower forehead temperature only for a period of time before falling asleep. In other examples, this technique can be used during the patient's sleep period or a portion thereof.

[0563] In some examples of this technology, such as in cold environments, heat transfer technology can be used to transfer heat to the forehead or any other part of the body.

[0564] In some examples of this technology, the cooling techniques described herein can be used to transfer heat away from other parts of a patient's body, or otherwise cool other parts of a patient's body. For example, it can be used to treat injuries or pain such as muscle pain caused by overuse.

[0565] In some embodiments, a temperature sensor or sensor array (such as a thermocouple) may be embedded in or in contact with one of the conductive material layers, or in contact with the forehead to sense forehead temperature. In some embodiments, a control loop may be established to achieve a specific temperature or a specific temperature profile. For example, ventilation flow rate may be automatically increased or decreased to achieve a target temperature or temperature profile.

[0566] In some embodiments, the device may include a sensor 8013 that includes EEG, ECG, and / or EMG sensing, and parameters of these signals may be used as control targets; for example, forehead cooling may be applied to reduce frontal cortical brain activity or heart rate. In some embodiments, cooling may be enhanced or diminished in the presence of rapid eye movements (REMs).

[0567] In other examples, the system designed in this paper can be configured to determine sleep by analyzing the patient's breathing waveform and, upon detecting sleep, control the forehead cooling system, such as disabling the cooling function or lowering the target cooling temperature.

[0568] In some embodiments, the system can be used as part of a broader relaxation procedure, for example, a patient can use the system while meditating or doing deep breathing exercises (or other relaxation techniques) before trying to sleep, or the system can be synchronized with guided relaxation procedures (such as guided deep breathing) or medication.

[0569] 5.8.3 Humidification and Cooling

[0570] In another example of this technology, the thermoelectric cooler 5005 can be used both to increase the temperature of the fluid supply for humidification purposes and simultaneously to decrease the temperature of the fluid supply for forehead cooling purposes. For example, see reference... Figure 14 The thermoelectric cooler 5005 may have a first side 5005A that is thermally bonded to a first fluid 8002 and a second side 5005B that is thermally bonded to a second fluid 8004. For example, the first fluid may be configured to make thermal contact with the patient's forehead, and the second fluid may be designed to be breathable by the patient during use.

[0571] In the example, the first fluid may be disposed in a first chamber or conduit, and the second fluid may be disposed in a second chamber or conduit.

[0572] In one example, the first fluid supply 8002 may be air flowing to or from the patient's forehead. For example, the first fluid supply may be configured to cool the patient's forehead directly or indirectly, such as by cooling a radiator attached to the patient's forehead. In other examples, the first fluid supply may be water or oil configured to cool the patient's forehead via a fluid delivery system as described herein.

[0573] In one example, the second fluid supply 8004 may be a breathable gas passing through one or more air circuits 4170. In another example, the second fluid supply may include water for humidifying an airflow intended for a patient to breathe; in yet another example, the second fluid supply may include humidified breathable gas.

[0574] 5.8.4 Example of exhaust airflow

[0575] In some examples of this technology, the air circuit 4170 may include a vent 3400 or a vent opening 3402 configured to expel exhaled air from the PAP system. Figure 7O An example of an air circuit including a vent is shown. Figure 15A An improved version of this air circuit 4170 is shown, wherein the air vent is provided with a conduit 15000, which is configured to direct an upward flow of air (generally indicated by arrow A) toward the patient's forehead. In other words, the air circuit 4170 includes a conduit 15000 configured to direct a portion of the airflow toward the patient's forehead during use.

[0576] In the illustrated example, the catheter 15000 is made of rigid plastic and includes a curved outlet 15002, which is angled relative to the longitudinal axis 'L' of the catheter 15000. This curved outlet 15002 provides directional control to the outgoing airflow, allowing the airflow to be directed back toward the patient's face and forehead. In some examples, the air circuit 4170 may include an anti-asphyxiation valve (AAV) configured to selectively control the outflow of air through the catheter 15000. Examples of AAVs can be found in U.S. Patent Publication No. 2006 / 0076017A1, published April 13, 2006, and U.S. Patent Publication No. 2009 / 0065729A1, published March 13, 2009, the entire contents of which are incorporated herein by reference.

[0577] For example, the AAV can be configured to expel air through catheter 15000 only during the patient's exhalation. In other examples, air circuit 4170 can be configured to continuously expel air through catheter 15000 during use.

[0578] Figure 15B Another version of the air circuit 4170 is shown, configured to direct airflow toward the patient's forehead. In this example, the catheter is positioned on the patient interface side of the decoupling structure 15004 such that the catheter's positioning relative to the patient interface remains substantially fixed, while the decoupling structure 15004 allows the air circuit to pivot or rotate about the decoupling structure 15004. Other forms of decoupling structures, such as swivel joints or ball-and-socket joints, will be well known to those skilled in the art.

[0579] Figure 15C It shows Figure 15A or Figure 15B An example of an air circuit used with a patient interface 3000, the patient interface including a nasal seal-forming structure 3100. It should be understood that the same air circuit 4170 can similarly be used with the patient interface 3000, the patient interface having a seal-forming structure 3100 configured to deliver a breathable gas flow to both the patient's oral and nasal airways during use.

[0580] As shown in the figure, the conduit 15000 extends from the air circuit 4170 in an upward direction toward the patient's forehead. In a preferred example, the end of the conduit 15000 is positioned higher than the nasal protuberance on the patient's face to ensure that the airflow does not interfere with or irritate sensitive areas of the patient's nose and / or restrict the airflow passing over the patient's eyes.

[0581] In the example shown, the catheter 15000 is positioned substantially centered relative to the patient's sagittal plane, which can advantageously prevent or limit dryness or irritation of the patient's eyes during use, i.e., the exhaust airflow is directed between the patient's eyes and (in the direction generally indicated by arrow A) to the forehead area.

[0582] Figure 16A and Figure 16B An alternative example of the present technology is shown, wherein a conduit 15000 is disposed in a patient interface 3000 to guide air exiting from the patient interface toward the patient's forehead. As in the previous example, the conduit 15000 may include a curved outlet 15002 configured to provide directional control to the exiting airflow, allowing the airflow (in a generally indicated direction by arrow A) to be directed back toward the patient's face and forehead. It should be understood that in each example, the airflow through the conduit 15000 may be controlled via a vent 3400 as described herein.

[0583] Figure 16BAn alternative design of the patient interface 3000 is shown, which includes a conduit 15000 configured to direct airflow to the forehead region of a patient. In this example, the conduit 15000 is adjustably connected to the patient interface, for example, via a support structure 15006 including a pivot 15008. This configuration can advantageously allow for adjustment of the airflow direction to accommodate differences in body shape between patients.

[0584] exist Figure 16B In this embodiment, the catheter is also positioned at a certain distance from the patient interface 3000. This allows for easy adjustment of the flow rate via the directional catheter, thereby regulating the airflow rate inhaled from the airway 3450 (not shown in this example). This spatial relationship also promotes the entrainment of air from the surrounding atmosphere, ensuring that the airflow delivered to the patient's forehead is a mixture of exhaust air and ambient air. Since the exhaust air may be heated by the patient's breathing and / or the RPT device 4000, the mixing of ambient air can advantageously generate a cooler airflow, further aiding in cooling the patient's forehead.

[0585] Figure 16C It shows Figure 16A or Figure 16B The patient interface 3000 is shown in a rear view in each of these examples. In each example, the patient interface 3000 includes a housing 3210, which may be made of a plastic such as polycarbonate. Attached to the housing 3210 is a sealing formation 3100 configured to deliver a breathable gas flow to the patient's nasal and oral airways.

[0586] In this example, the sealing structure 3100 includes a nasal portion 3230 and a mouth portion 3260. The nasal portion is configured to engage with a surface on the lower side of the patient's nose during use, for example, abutting against the nasal protuberance, the sides of the nose, and the upper part of the lips in a forward direction. The mouth portion is configured to seal around the patient's oral airway during use.

[0587] Another example of this type of patient interface is described in PCT Publication No. WO2019183680A1, published on October 3, 2019, the entire contents of which are incorporated herein by reference.

[0588] In the illustrated example, the catheter 15000 extends from the housing 3210 of the patient interface 3000, either via direct connection to the housing 3210 (including attachment to the housing, removable connection to the housing, or being molded into part of the housing) or by a distance relative to the housing 3210. In these examples, the housing 3210 may similarly be constructed of rigid plastic (such as polycarbonate) or other suitable plastic material. This can advantageously provide an airflow path between the inflation chamber 3200 and the patient's forehead.

[0589] Figure 17A Another example of a 'pipe-up' system is illustrated, which is combined with... Figure 7L The systems described are essentially the same. However, in this example, the airflow deflector 17000 is attached to the connection port 3600 to direct airflow in a forward-downward direction (approximately in the direction indicated by arrow A) to the patient's forehead. The airflow deflector includes a conduit 15000 that is bent to conform to the contours of the patient's head during use and directs airflow in a forward-downward direction to the patient's forehead.

[0590] In some examples, the airflow deflector 17000 may be a removable component that is removably attached to the connection port 3600. For example, the airflow deflector 17000 may be positioned at the connection port 3600 and the air circuit 4170 ( Figure 17A (not shown) to receive airflow from RPT device 4000 and direct that airflow to the patient’s forehead.

[0591] In other examples, the airflow deflector 17000 may be configured as part of the connection port 3600. In other words, the connection port 3600 may include a conduit 15000 configured to direct airflow toward the patient's forehead.

[0592] Figure 17B Another example of an airflow guide 17000 is shown, which can be connected to a connection port 3600. In this example, the catheter 15000 is a flexible tube that can be repositioned as needed to direct airflow to a desired area on the patient's forehead. In some examples, it may be advantageous for the catheter 15000 to retain its shape after being bent into a desired configuration; in other words, the material of the catheter can be chosen to provide shape-retention properties. For example, this can be achieved with a flexible metal tube (such as a bendable copper or aluminum tube), or the catheter may include accordion-style or gooseneck segments, which are common in plastic straws. In other examples, the catheter may be provided with one or more rotary connectors that allow one or more segments of the catheter to be manipulated relative to other segments.

[0593] In this example, the positioning and stabilizing structure 3300 may include one or more mounting elements 17002 for retaining the catheter 15000. For example, the mounting element 17002 may be a snap fastener having a receiving cavity configured to receive the catheter 15000, or may provide any other suitable form of fastening, such as using hook and loop fasteners, snaps, and buckles.

[0594] Figure 17C Another example of a tube-up configuration is shown, which has the same characteristics as in Figure 17 and Figure 7LA similar overall structure. However, in this example, the positioning and stabilizing structure 3300 includes a pair of opposing catheters 15000 configured to guide airflow from opposing sides 4171, 4172 of the positioning and stabilizing structure 3300 (in a direction generally indicated by arrow A) inward toward the patient's forehead. It should be understood that in some examples, only a single catheter may be used; for example, the positioning and stabilizing structure 3300 may be configured to guide airflow from one side of the positioning and stabilizing structure.

[0595] 5.8.4.1 Compact Vent Design

[0596] Figures 18A to 18C An example of a flow-adjustable compact airway 3450 is shown, which is configured to direct airflow from the patient interface 3000 toward the patient's forehead.

[0597] In this example, the vent 3450 includes a central component 3456 and a housing 3466. The main venting path is provided within a gap 3464 between the central component 3456 and the housing 3466. Flow through this gap is configured by appropriately dimensionalizing the gap.

[0598] The hole 18002 is provided in the side wall or recess 3416 of the outer component such that when connected to the patient interface, the hole 18002 faces the patient's forehead and acts as a conduit that guides part of the airflow that will be discharged through the side wall 3416 toward the patient's forehead during use.

[0599] In some examples, the central component 3456 may be rotatably connected to the housing 3466 and may include one or more flow control orifices 18000, for example, such as Figure 18C The illustrations show flow control orifices of different sizes. In use, rotating this central component 3456 adjusts which flow control orifice 18000 aligns with the orifice 18002 in the housing 3466. A larger orifice results in increased airflow, while a smaller orifice (or rotating the central component to a position where no orifice alignment occurs) results in reduced or restricted airflow. Therefore, by rotating the central component relative to the housing 3466, the flow control orifice aligns with the orifice 18002. Figure 18A The illustrated airflow is directed toward the patient's forehead.

[0600] 5.8.5 Other Examples

[0601] Figure 19AAn example of a system 19000 is shown, comprising a patient interface 3000 and a positioning and stabilization structure 3300, the patient interface and the positioning and stabilization structure being configured to operate as independent units for delivering a breathable gas flow to a patient's airway. The system includes a power source 6030 (such as a battery) and a flow generator 6400 configured to generate a breathable gas flow to the patient's airway via a sealing formation structure 3100. Further details regarding these types of systems can be found in PCT application No. PCT / AU2024 / 050419, filed May 2, 2024, the entire contents of which are incorporated herein by reference.

[0602] In this example, system 19000 includes catheter 15000 which is fluidly connected to flow generator 6400 and is configured to direct airflow from flow generator 6400 in an up-back direction (in the direction generally indicated by arrow A) toward the patient’s forehead.

[0603] In another example, the conduit 15000 can be configured to act as an air inlet and draw ambient air into the flow generator 6400. By angling the conduit toward the user's forehead, the air inlet allows incoming air to be drawn in from the patient's forehead area in a forward-downward direction, thereby cooling the patient's forehead during use.

[0604] In other examples, any of the methods described in this article can be used (including, for example, using installation to, e.g., ...). Figure 19B One or more catheters of the illustrated positioning and stabilizing structure 3300 are used to direct airflow toward or draw airflow from the patient's forehead region. For example, the catheters may be fluidly connected to the flow generator 6400 via one or more air circuits (such as fabric air circuits) located within or attached to the positioning and stabilizing structure.

[0605] Figure 20A Another example of the technology is shown, which may incorporate a flow generator 6400, a sealing formation 3100, and a positioning and stabilizing structure 3300. The flow generator is configured to generate a breathable gas flow, the sealing formation is used to deliver the breathable gas flow to the patient's airway, and the positioning and stabilizing structure is configured to support these components on the patient's head during use. In this example, the power source 6020 is supplied via a cable, such as from an external battery or power source (such as a USB interface or power adapter).

[0606] In this example of the technology, the positioning and stabilizing structure 3300 includes a headband, loop 8378, or annular element configured to extend around the patient's head from the patient's frontal bone to the patient's occipital bone. In the illustrated example, the loop 8378 may be a continuous material element, although in other examples, the loop 8378 may include multiple elements that allow adjustment of the length of the loop 8378.

[0607] In use, the ring structure is configured to be placed on the patient's forehead, and therefore can be equipped with any of the forehead cooling systems described herein in the forehead cooling system 2000, including but not limited to air or fluid cooling systems, PCM materials, and thermoelectric cooling systems.

[0608] In some examples, the ring 8378 may be equipped with one or more sensors 8013 configured to measure one or more characteristics of the patient. For example, the sensors may include a temperature sensor, a humidity sensor, a heart rate sensor, or an EEG sensor. These sensors 8013 may be configured to communicate patient information to a controller to control any one or more operating parameters of the system's operating parameters, such as active cooling or flow characteristics of the forehead region.

[0609] While not an essential component of the invention, in this example, the device also includes an audio system 6800 comprising a pair of output devices 6804. Each output device 6804 can output sound to one ear of the patient. In the illustrated example, the output devices 6804 are formed as earmuffs and can rest against and / or close each of the patient's ears. In other examples (not shown), the output devices 6804 may be earplugs fitted into the patient's ears. These audio systems can be integrated with the control systems described herein to provide auditory stimulation, such as white noise, to aid sleep at appropriate times or at appropriate stages of the patient's sleep cycle (such as during light sleep), and auditory stimulation, such as alarm clocks or natural sounds, to aid wakefulness.

[0610] Further details regarding these types of systems and apparatus can be found in PCT application No. PCT / AU2024 / 050419, filed on 2 May 2024, the entire contents of which are incorporated herein by reference.

[0611] Figure 20B Another form of the present technology is shown, in which the forehead cooling system 2000 described herein can be provided in the absence of respiratory therapy techniques. For example, any one or more forehead cooling systems of the forehead cooling system 2000 can be incorporated into the positioning and stabilizing structure 3300 (such as a headband or ring 8378).

[0612] Figure 20CA top view of a forehead cooling system 2000 configured to engage with the forehead of a patient 1000 is shown. In this example, the forehead cooling system includes a housing 20002 attached to a positioning and stabilizing structure 3300. The housing includes a blower 20004 configured to circulate airflow through the housing to cool the user's forehead during use. The blower 20004 may be an axial blower, a piezoelectric blower, or any other type of blower known to those skilled in the art.

[0613] The housing is provided with an inlet 20006 and one or more outlets 20008A, 20008B through which airflow passes during use. The airflow can be bidirectional, i.e., airflow is drawn in from above the patient's forehead and discharged outwards in an upward or forward direction relative to the patient's head; or airflow is drawn in from the front of the patient's forehead, flows across the forehead and is discharged in a lateral direction relative to the forehead.

[0614] In some examples, the forehead cooling system may also include one or more sensors 8013 configured to measure humidity, temperature, heart rate, or provide electroencephalogram (EEG) information about the user. For example, the sensors may include thermocouples, EEG electrodes, and / or electrooculogram (EOG) electrodes.

[0615] Control of the forehead cooling system 2000 can be performed using any of the methods described herein. For example, in one embodiment, the forehead cooling system 2000 can adjust the flow rate of the blower 20004 to maintain a target forehead temperature.

[0616] In some examples, it may be beneficial to determine the patient's sleep state and then set the target temperature control accordingly. For example, it may be advantageous to provide a lower target temperature (such as approximately 15 degrees Celsius) and an appropriate blower speed (20004) to achieve that temperature before falling asleep. For instance, the blower speed (20004) can be determined based on the ambient temperature and the user's forehead temperature, thus using a faster blower speed (20004) when the difference between the target temperature and the measured temperature is greatest, and a slower speed when the temperature difference is small (such as within 0 to 3 degrees of the target temperature).

[0617] Once sleep is detected, it may be beneficial to set a second target temperature, different from the first target temperature. For example, the second temperature could be higher than the temperature used before falling asleep. For instance, the second temperature could be approximately 20 degrees Celsius. Furthermore, limiting the blower speed (20004) may be beneficial to reduce noise and vibration.

[0618] In some examples of this technology, it may be beneficial to set the target temperature and / or fan speed based on the user's sleep depth. For example, a lower set temperature can be used when forehead heat is detected or, for example, a high level of brain activity is detected. Furthermore, it may be beneficial to set the target temperature and fan speed based on the detected sleep state (such as wakefulness, N1, N2, N3, or REM sleep states, or any one or more). For example, a first target temperature in wakefulness sleep, a second target temperature in N1 sleep, a third target temperature in N2 sleep, a fourth target temperature in N3 sleep, and a fifth target temperature in REM sleep.

[0619] In some examples of this technology, it may be beneficial to control the blower speed based on the ambient temperature in the environment or to control the cooling power when a thermoelectric cooler is used.

[0620] In some examples, it may be more advantageous to estimate the heat transfer rate based on the measured or estimated forehead temperature and its change in response to changes in the target temperature and / or blower speed. The estimated heat transfer rate can then be used to adjust the blower speed, or, in the case of a thermoelectric cooler, to adjust the cooling power based on the estimated heat transfer rate / efficiency of the forehead cooling system 2000.

[0621] In some examples, the blower speed can be adjusted by regulating the power or control method of blower 20004 (such as PWM control). In other examples, the flow path can be modified using airflow deflectors. In other words, inlet 20006 and / or outlet 20008A, 20008B can be modified to control effective cooling of the forehead during use.

[0622] Figure 21A and Figure 21B Another form of the present technology is illustrated, in which the forehead cooling system 2000 described herein can be applied to other applications such as virtual reality (VR) systems, augmented reality (AR) systems, and mixed reality (XR) systems (referred to herein as VR devices for brevity). In this example, the VR device 12000 includes a flow generator 6400 and typical features of VR devices (such as a display 12070), the flow generator being configured to generate a breathable gas flow to the patient's airway via a sealing formation 3100, and the display being configured to present images or video streams for the patient to view during therapy.

[0623] Since the VR device 12000 includes a forehead support 12100, the forehead support may be adapted to include one or more sensors 8013 or a forehead cooling system 2000 as described herein. For example, a thermoelectric cooler may be positioned in contact with the forehead, and one or more sensors may be used to monitor the forehead condition / temperature during use. Because the VR device 12000 is positioned in an area adjacent to the patient's forehead, the forehead cooling system 2000 described herein can be incorporated to simultaneously cool the patient's forehead.

[0624] In another example, a portion of the airflow generated by or drawn into the flow generator 6400 may be guided toward / from the patient's forehead region using a catheter 15000 as described herein. In other examples, a pad 12100 adjacent to the patient's forehead may be provided with PCM material or a thermoelectric cooler as described herein.

[0625] exist Figure 21A and Figure 21B In this embodiment, the VR device 12000 includes a patient interface 3000; however, this patient interface is not essential for this technology. For example, the VR device 12000 may be equipped with a forehead cooling system 2000 without requiring a patient interface.

[0626] It should be understood that multiple forehead cooling systems 2000 have been described herein, and any one or more of these systems 2000 can be combined with any other system among the other systems 2000 described herein. For example, combining Figures 8A to 14 , Figure 20A or Figure 20B The contact forehead cooling system described by any one of them can be with Figures 15A to 19B Any combination of non-contact forehead cooling systems in a non-contact forehead cooling system. In other examples, multiple contact coolers, such as thermoelectric cooler 5005, and such as combined... Figures 8A to 10 The fluid cooler described. In yet another example, multiple non-contact forehead cooling systems can be combined, such as Figures 15A to 16C or Figures 18A to 19B The airflow of any one of them and the combination of Figures 17A to 17C The airflow combination described in the air circuit 4170 or connection port 3600.

[0627] Therefore, one aspect of this technology relates to an RPT system that combines two or more forehead cooling systems 2000 as described herein.

[0628] 5.8.6 Control System

[0629] Figure 22AAn example system 9000 is described, which can be implemented to monitor sleep, provide insights and / or recommendations, and or control the operation of a forehead cooling system as described herein. System 9000 typically includes one or more servers 9010, one or more communication networks 9030, and one or more computing devices 9040. Servers 9010 and computing devices 9040 can also communicate via one or more communication networks 9030 with one or more respiratory therapy devices (e.g., but not limited to, the RPT device 4000, sensor 8013, and forehead cooling system 2000 described herein).

[0630] One or more communication networks 9030 may include, for example, the Internet, a local area network (LAN), a wide area network (WAN), and / or a personal area network (PAN) implemented via a wired communication network 9032, a wireless communication network 9034, or a combination thereof (e.g., a wired network with a wireless link). In one form, the local communication network may utilize one or more communication standards, such as Bluetooth, near field communication (NFC), or consumer infrared protocols.

[0631] Server 9010 may include a processing facility represented by one or more processors 9012, memory 9014, and other components typically present in such a computing environment. The processing power of processor 9012 may be provided, for example, by one or more general-purpose processors, one or more dedicated processors, or by cloud computing services that provide access to a pool of shared computing resources configured according to desired characteristics, service models, and deployment models. In the illustrated example, memory 9014 stores information accessible to processor 9012, including instructions 9016 executable by processor 9012 and data 9018 retrieved, manipulated, or stored by processor 9012. Memory 9014 may be any suitable means known in the art capable of storing information in a manner accessible to processor 9012, including computer-readable media or other media storing data readable by means of electronic devices. Although processor 9012 and memory 9014 are illustrated within a single unit, it should be understood that this is not intended to be limiting, and the functionality of each as described herein may be performed by multiple processors and memories, which may or may not be remote from each other and the rest of system 9000.

[0632] Instruction 9016 may include any set of instructions suitable for execution by processor 9012. For example, instruction 9016 may be stored as computer code on a computer-readable medium. Instructions may be stored in any suitable computer language or format. Data 9018 may be retrieved, stored, or modified by processor 9012 according to instruction 9016. Data 9018 may also be formatted in any suitable computer-readable format. Furthermore, although data is illustrated as being contained in a single location, it should be understood that this is not intended to be limiting—data may be stored in multiple memories or locations. Data 9018 may include one or more databases 9020.

[0633] In some instances, server 9010 can communicate unidirectionally with computing device 9040 by providing information to one or more of them, and vice versa. In other embodiments, server 9010 and computing device 9040 can communicate bidirectionally with each other and can share information and / or process tasks.

[0634] 5.8.6.1 Computing Device

[0635] The computing device 9040 can be any suitable processing device, such as, but not limited to, a personal computer such as a desktop or laptop computer 9042, or a mobile computing device such as a smartphone 9044 or a tablet 9046. Figure 22B An exemplary general architecture 9100 of a computing device 9040 is depicted. The foregoing discussion describes components of the computing device, which may be equivalent to a combination of Figure 22A The components of the server described are otherwise identical to those of the server; however, for clarity, the components of the computing device have been labeled with different reference numerals.

[0636] The computing device 9040 may include one or more processors 9110. The computing device 9040 may also include a memory / data storage device 9120, an input / output (I / O) device 9130, and a communication interface 9150.

[0637] The one or more processors 9110 may include functional components used in the execution of instructions, such as functional components for fetching control instructions from a location such as a memory / data storage device 9120, decoding program instructions, executing program instructions, and writing the results of the executed instructions.

[0638] The memory / data storage device 9120 may be the internal memory of the computing device, such as RAM, flash memory, or ROM. In some instances, the memory / data storage device 9120 may also be external memory linked to the computing device 9040, such as an SD card, USB flash drive, optical disc, or remote storage (e.g., accessed via a server such as server 9010). In other instances, the memory / data storage device 9120 may be a combination of external and internal memory.

[0639] As described herein, the memory / data storage device 9120 includes processor control instructions 9122 that instruct the processor 9110 to perform certain tasks and stored data 9124. As described above, in this example, the instructions may be executed by resources associated with the server 9010 communicating with the computing device 9040, and may be data stored in and / or accessed from resources associated with the server 9010 communicating with the computing device 9040.

[0640] In the example, input / output (I / O) device 9130 may include one or more displays 9132. In the example, display 9132 may be a touch-sensitive screen that allows user input in addition to outputting visual information to a user of computing device 9040. In the example, the I / O device may include other output devices, including one or more speakers 9134 and haptic feedback devices 9136. In the example, input / output (I / O) device 9130 may include input devices such as physical input devices 9138 (e.g., buttons or switches), sensors 8013 including, for example, optical sensors 9140 (e.g., one or more imaging devices such as cameras), sound sensors or audio input devices (such as microphones that allow patients to use their voice or voice control devices), and inertial sensors 9142 (particularly in the example where computing device 9040 is a mobile computing device). It should be understood that other I / O devices 9130 may be included, or accessed in other ways via I / O interface 9150 (e.g., interfacing with peripheral devices connected to computing device 9040). The communication interface 9160 enables the computing device 9040 to communicate via one or more networks 9030.

[0641] 5.8.6.2 Computer-Available Methods

[0642] Computer-readable instructions can implement the exemplary methods described herein. In the examples, computer-readable instructions include one or more algorithms for execution by one or more processors in the processor 9012 described herein. Instructions for performing these functions may optionally be included in a non-transitory computer-readable storage medium (e.g., memory 9014) or other computer program product configured for execution by one or more processors 9012. A computer-readable storage medium can be a tangible means capable of holding and storing instructions for use by an instruction execution device. A computer-readable storage medium can be, for example, but not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the foregoing. As used herein, a computer-readable storage medium should not be construed as a transient signal (such as radio waves or other freely propagating electromagnetic waves, electromagnetic waves propagating through waveguides or other transmission media, or electrical signals transmitted through wires) itself.

[0643] However, those skilled in the art will readily understand that the entire algorithm and / or parts thereof can alternatively be executed by means of devices other than a processor and / or embodied in firmware or dedicated hardware in a known manner. For example, the entire algorithm and / or parts thereof can be implemented by application-specific integrated circuits (ASICs), programmable logic devices (PLDs), field-programmable logic devices (FPLDs), field-programmable gate arrays (FPGAs), discrete logic, etc. For example, any or all of the components can be implemented by software, hardware, and / or firmware. Furthermore, some or all of the instructions represented by the flowchart can be implemented manually. Moreover, although the example algorithm is described with reference to the illustrated flowchart, those skilled in the art will readily understand that many other methods of implementing the example processor-readable instructions can be used alternatively. For example, the execution order of the boxes can be changed, and / or some of the boxes described can be modified, eliminated, or combined.

[0644] As used herein, the terms “component,” “module,” “system,” etc., generally refer to a computer-related entity, or hardware (e.g., circuitry), a combination of hardware and software, software, or an entity associated with an operating machine having one or more specific functions. For example, a component can be, but is not limited to: a process running on a processor, a processor, an object, an executable program, a thread of execution, a program, and / or a computer. For illustration, an application running on a controller and the controller itself can both be components. One or more components may reside within a process and / or a thread of execution, and components may be localized on a single computer and / or distributed across two or more computers. Furthermore, a “device” can take the form of: specially designed hardware; general-purpose hardware specialized by executing software thereon that enables the hardware to perform specific functions; software stored on a processor-readable medium; or a combination thereof.

[0645] 5.8.6.3 Circadian Rhythm Support

[0646] In an example of this technology, the forehead cooling system 2000 described herein can be controlled to support an individual's healthy sleep cycle. For example, the forehead can be actively cooled during the first stage of the sleep cycle to aid in falling asleep. Then, once sleep is detected, cooling can be paused (or the cooling power reduced).

[0647] There are multiple ways to detect falling asleep, including but not limited to monitoring the patient’s biometric signals (i.e., using one or more sensors 8013, such as a heart rate sensor or an EEG sensor) or by monitoring the patient’s respiratory waveform.

[0648] In some examples, the system can be configured to detect when a patient wakes up at night, and in these examples, the system can detect the event and cool the forehead again to help the patient fall back asleep.

[0649] In the morning, forehead cooling systems can be used to assist patients in waking up, for example, according to an alarm set on a mobile device or during the natural waking phase of a patient's sleep cycle. For example, in the case of a thermoelectric cooling system, the voltage polarity can be reversed, and the patient's head can be heated to assist in waking up.

[0650] Figure 23 An example of a control system configured to control the forehead cooling system described herein is shown. As shown, the system is turned on or activated by the patient. This can be done when the device is first turned on, or, in the case of an RPT device, when pressurized respirable gas delivery is initiated.

[0651] Once activated, the system is configured to begin collecting patient information from one or more sensors 8013. This patient information may include, for example, forehead temperature readings, heart rate readings, respiratory waveforms, etc.

[0652] This information is then compared to a set of predefined control rules. For example, this could include detection:

[0653] • Whether the patient is awake, and whether the forehead temperature is above, within, or below a predefined threshold.

[0654] Whether the patient falls asleep, and whether the forehead cooling system should be turned off, started at low power, or configured to achieve a predefined sleep temperature range.

[0655] If any of the predefined rule criteria are met, the control system is configured to perform the corresponding action. For example, controlling the forehead cooling system according to predefined rules.

[0656] The predefined rules can be selected by the user from a list of pre-configured settings. For example, a setting can be provided to keep cooling enabled at night, and an alternative setting can be provided to disable cooling once sleep is detected.

[0657] In other examples, predefined rules can be automatically adjusted over time. For instance, if better sleep quality is detected under certain conditions (e.g., by monitoring breathing, heart rate, temperature, and / or EEG data), these conditions can be automatically learned and repeated on subsequent nights. Conversely, if poor sleep is detected, a forehead cooling system can be configured to activate, such as by cooling the forehead to better regulate the patient's sleep.

[0658] In some examples, predefined rules can be automatically adjusted for environmental changes, such as ambient temperature or noise levels. For instance, on a night when the ambient temperature is measured at 27 degrees Celsius, the system can be configured to set the cooling temperature to 15 degrees and the sleep temperature between 20 and 25 degrees Celsius. On a night when the ambient temperature is measured at 22 degrees Celsius, the system can be configured to set the cooling temperature to 15 degrees Celsius and the sleep temperature between 18 and 22 degrees Celsius.

[0659] In another example, the target temperature curve can vary overnight, for example, to match the detected sleep stages of the patient. This can generate any suitable target temperature and slope setting as needed.

[0660] 5.8.6.4 User Control and Feedback

[0661] Figure 24 An example of a personal computing device 9040, such as a smartphone, is shown. The computing device 9040 can be configured to allow a patient to monitor and / or control their preferred sleep patterns, for example, by adjusting predefined rules described herein. In some examples, this control functionality may alternatively be provided by a user interface on the RPT device 4000.

[0662] In the illustrated example, the computing device 9040 is configured to present a list of configurable settings to the patient / user, which can be adjusted as needed to adapt to predefined rules considered by the cooling system described herein. For example, the user can set a target sleep duration, sleep temperature, configure automatic sleep detection, enable a wake-up alarm (including auditory cues and forehead heating options), configure whether cooling is needed during sleep, whether white noise should be provided to aid sleep, and whether settings should automatically adapt during use. The foregoing is intended to be a non-exhaustive list, and in some examples, advanced settings menus may be provided to allow the user to configure advanced parameters such as target temperature range, heating and cooling slope settings, etc.

[0663] In some examples, the computing device 9040 may also provide the patient / user with detailed information about the quality, duration, and effectiveness of the forehead cooling system 2000 described herein. For example, it may be advantageous for the system described herein to collect the user's sleep information in a range of situations, such as enabling and disabling forehead cooling, applying and disabling auditory stimulation, or using and not using respiratory pressure therapy, in order to determine the effectiveness of any one or more of the provided settings.

[0664] An example of this technology provides a forehead cooling system 2000 that can be manually adjusted / controlled by a patient 1000. For example, relative to... Figures 18A to 18C Manual adjustment can be performed by rotating the central component 3456 relative to the housing 3466. However, in other examples of this technology, cooling control can be performed using any one or more of the following: controlling the size of the conduit 15000, for example by closing or restricting a portion of the conduit or diverting a portion of the flow through the conduit 15000; directing the flow through the conduit 15000, i.e. by redirecting the airflow, by adjusting the cooling or heating power (in the case of using the thermoelectric cooler 5005); controlling the flow rate or volume, for example using the RPT device 4000 or a flow generator, or a personal computing device communicating with the RPT device 4000 or the flow generator.

[0665] In other examples, the system described herein may be equipped with controls such as sliders, knobs, dials, proximity or touch-sensitive interfaces, which the patient 1000 can use to control the device, such as raising or lowering the temperature setpoint or adjusting the flow rate.

[0666] In some examples of this technology, the forehead cooling system 2000 can be controlled using one or more voice commands, such as “lower temperature,” “stop cooling,” “increase flow,” etc. For example, as described herein, the forehead cooling system or any associated processor 9012 (such as the RPT device 4000, a flow generator, or a processor in a personal computer) can be connected to a sensor 8013 in the form of a microphone, configured to acquire audio. The processor 9012 can then process the audio to implement control actions, such as controlling the operation of the forehead cooling system 2000 in response to instructions.

[0667] By allowing the patient to directly control the forehead cooling system 2000, this technology can make the patient 1000 more comfortable and improve patient adherence to any therapy provided by the forehead cooling system 2000. When manual control is provided, this advantageously allows the patient to easily make adjustments, for example, while lying in bed, without having to navigate complex menus, thereby further enhancing the ease of use of the system described herein.

[0668] In some examples of this technology, manual controls can serve to override any pre-configured therapy settings. For example, these manual settings can replace any existing settings, or alternatively, the system can be configured to return to pre-configured settings once a change in sleep state is detected. For example, the system can be configured to return to pre-configured settings once sleep onset occurs or once the patient enters an N1, N2, N3, or REM sleep state.

[0669] In some examples, the overriding settings may only affect settings that are active when the patient is awake.

[0670] Where the settings can be adjusted by the user, it may be advantageous for these settings to remain consistent, allowing them to be maintained across different time periods.

[0671] Each of these controls can be used with any one or more forehead cooling systems described herein. For example, in the case of using thermoelectric cooler 5005, these settings can be used to adjust the cooling setpoint, temperature slope, etc., and in the example of using fluid flow (such as water or airflow), the control can be configured to adjust the flow rate, flow rate, temperature, directionality, or timing of the flow.

[0672] 5.9 Glossary

[0673] To achieve the purposes of this technical 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.

[0674] 5.9.1 General

[0675] 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.

[0676] Environment: In some forms of this technology, the term environment will be considered to mean (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0677] For example, the environment relative to a humidifier humidity This could be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's bedroom. This type of ambient humidity can differ from the humidity outside the patient's bedroom.

[0678] In another example, environmental stress can be stress that is either close to the body or outside the body.

[0679] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the room where the patient is located, rather than noise generated, for example, by the RPT device or emitted from the mask or patient interface. Ambient noise may be generated by sources outside the room.

[0680] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum (e.g., varying with each breath) depending on the presence of an indication of an SDB event.

[0681] Continuous positive airway pressure (CPAP) therapy: a respiratory pressure therapy in which the treatment pressure is kept substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet is 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 when no indication of partial upper airway obstruction is detected.

[0682] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, referring to flow rate will refer to a scalar, that is, a quantity that only has magnitude. In other cases, referring to flow rate will refer to a vector, that is, a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. "Flow rate" is sometimes simply abbreviated as "flow" or "airflow".

[0683] In the example of patient breathing, the flow rate may be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Device flow rate Qd is the flow rate of air 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 flow rate of air leaving the vent to allow flushing of exhaled gas. Leakage flow rate Ql is the flow rate leaking from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received from the patient's respiratory system.

[0684] Flow therapy: This includes respiratory therapy that delivers a controlled flow of air to the airway inlet at a rate known as therapeutic flow, which is typically positive throughout the patient’s respiratory cycle.

[0685] Humidifier: The term humidifier will be considered to refer to a humidifying device that is constructed and arranged or configured with a physical structure to provide a therapeutically beneficial amount of water (H2O) vapor to an airflow to alleviate a patient’s medical respiratory symptoms.

[0686] Leakage: The term "leakage" will be considered as an unintended flow of air. In one example, a leak might occur due to an incomplete seal between the mask and the patient's face. In another example, a leak might occur in a bend in the swivel tube leading to the environment.

[0687] Conducted noise (acoustic): In this document, conducted noise refers to noise transmitted to the patient through pneumatic paths, 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.

[0688] Radiated noise (acoustics): In this document, radiated noise refers to noise transmitted to the patient by ambient air. In one form, radiated noise can be quantified according to ISO 3744 by measuring the sound power / sound pressure level of the object under discussion.

[0689] Vent noise (acoustic): Vent noise in this document refers to the noise generated by the airflow through any vent (such as the vent hole of a patient interface).

[0690] Oxygen-enriched air: Air with an oxygen concentration greater than that of atmospheric air (21%), for example, at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "Oxygen-enriched air" is sometimes shortened to "oxygen".

[0691] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0692] Patient: A person, regardless of whether they have a respiratory illness.

[0693] Pressure: Force per unit area. Pressure can be expressed in units, including cmH2O and gf / cm². 2 And 1000 pascals. 1 cmH2O equals 1 g-f / cm 2 And it is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m). 2 =1 millibar to 0.001 atmospheres. In this specification, unless otherwise stated, pressure is given in cmH2O.

[0694] 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.

[0695] Respiratory pressure therapy: Applying an air supply to the airway entrance at a therapeutic pressure that is normally positive relative to the atmosphere.

[0696] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0697] 5.9.1.1 Materials and their properties

[0698] Hardness: refers to the hardness of a hardness tester or indentation hardness, which is a material property measured by indentation through an indenter (e.g., as measured according to ASTM D2240).

[0699] • "Soft" materials may include silicone resins or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0700] • "Hard" materials can include polycarbonate, polypropylene, and can be, for example, not easily deformed under finger pressure.

[0701] Silicone resin or silicone elastomer: a synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or compression-molded 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.

[0702] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0703] 5.9.1.2 Mechanics

[0704] axis:

[0705] a. Neutral axis: An axis in the cross-section of a beam or plate that has no longitudinal stress or strain.

[0706] b. Vertical axis: The axis that extends along the length of the shape. This axis usually passes through the center of the shape.

[0707] c. Circumferential axis: An axis oriented perpendicularly to the longitudinal axis. This axis can specifically exist in pipes, tubes, cylinders, or similar shapes with circular and / or elliptical cross-sections.

[0708] Deformation: The process by which the original geometry of a component changes when subjected to a force (e.g., a force in the direction relative to an axis). This process can include stretching or compression, bending, and twisting.

[0709] Elasticity: The ability of a material to return to its original geometry after deformation.

[0710] Flexible structures or components: structures or components that will change shape (e.g., bend) when made to support their own weight for a relatively short period of time, such as 1 second.

[0711] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0712] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain silicone resins and thermoplastic elastomers.

[0713] Rigid structures or components: Structures or components that will not substantially change shape when subjected to the loads typically encountered during use. An example of such use could be, for instance, setting and maintaining a seal between the patient interface and the inlet of the patient's airway at a pressure of approximately 20 to 30 cmH2O.

[0714] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component may be flexible in the first direction and rigid in the second direction.

[0715] 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 opposite of stiffness is flexibility.

[0716] Viscosity: The ability of a material to resist flow.

[0717] Viscoelasticity: The ability of a material to exhibit both elastic and viscous behavior during deformation.

[0718] Yield: The condition where a material, after being deformed, no longer returns to its original geometry.

[0719] 5.9.1.3 Structural Components

[0720] Compression component: A structural element that resists compressive forces.

[0721] Bend: A bend is an example of a structure that guides the axis of an airflow traveling through it to change direction at an angle. In one form, the 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, approximately 360 degrees. In some forms, the bend can be removable from the mating component, for example, via a snap-fit ​​connection. In some forms, the bend can be assembled onto the mating component during manufacturing via a disposable snap-fit, but cannot be removed by the patient.

[0722] Frame: The frame is generally considered to refer to the mask structure that bears the tensile load between two or more connection points to the hood. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0723] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0724] Lacing (noun): A structure designed to resist tension.

[0725] Thin structure:

[0726] a. beam,

[0727] i. Compared to the other two dimensions, the beam can be relatively long in one dimension, making the smaller dimension relatively thinner compared to the longer dimension.

[0728] b. membrane,

[0729] i. Relatively long in two dimensions and relatively thin in one dimension. Easily deforms in response to bending forces. Resistant to tension (and possibly compression).

[0730] c. Plates and casing

[0731] i. They can be relatively long in two directions and relatively thin in one dimension. They can have bending, tensile, and / or compressive stiffness.

[0732] Thick structure: solid

[0733] Sealing: can be the noun form referring to a structure ("sealing element") or the verb form referring to an effect ("sealing"). Two elements can be constructed and / or arranged to "seal" or to achieve "sealing" between them without requiring a separate "sealing element" element itself.

[0734] Shell: A shell is generally considered to refer to a curved, relatively thin structure with bending, tensile, and compressive stiffness. For example, the curved structural walls of a face mask can be an outer shell. In some forms, the outer shell can be multifaceted. In some forms, the outer shell can be airtight. In some forms, the shell may not be airtight.

[0735] 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.

[0736] Column: A column is considered a structural component designed to increase the compressive strength of another component in at least one direction.

[0737] Rotary shaft (noun): A sub-assembly of a component configured to rotate, preferably independently, about a common axis, 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 ducts, the sub-assembly of the component preferably comprises a pair of mating cylindrical ducts. In use, little or no airflow leaks from the rotary shaft.

[0738] 5.9.2 Anatomy

[0739] 5.9.2.1 Facial Anatomy

[0740] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0741] Nasal wing angle: The angle formed between the nasal wings of each nostril.

[0742] Alar tip: the outermost point on the ala of the nose.

[0743] Alar curvature (or alar ridge) point: the last point in the curvature baseline of each alar, found in the crease formed by the connection between the alar and the cheek.

[0744] Auricle: The entire visible external part of the ear.

[0745] (Nose) Skeletal framework: The skeletal framework of the nose includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0746] (Nasal) Soft cartilage: The nasal soft cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0747] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0748] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt horizontal plane that intersects the subnasal point.

[0749] Frankfurt Plane: A line extending from the lowest point of the eye socket margin to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0750] The glabella is located on the soft tissue at the most prominent point in the sagittal plane at the center of the forehead.

[0751] External nasal cartilage: a cartilaginous plate that is basically triangular in shape. 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.

[0752] Lower lip (midpoint of the lower lip): The lip that extends between the point below the nose and the mouth.

[0753] Upper lip (midpoint of the upper lip): The lip that extends between the mouth and the supramental point.

[0754] 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 comprising three or four smaller cartilages, including the alar.

[0755] Nostrils: Roughly oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils (nares) is nasal nasal (naris) (nostril). Nostrils are separated by the nasal septum.

[0756] Nasolabial folds or nasolabial creases: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0757] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0758] The lowest point on the face where the auricle attaches to the skin.

[0759] The highest point on the face where the auricle attaches to the skin.

[0760] 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.

[0761] The philtrum is a midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0762] Prechin point: Located on the soft tissue, at the very front midpoint of the chin.

[0763] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0764] Sagittal plane: A vertical plane running from front to back. The central sagittal plane divides the body into the right and left halves.

[0765] Nasal bridge point: Located on the soft tissue, it is the most concave point on the forehead-nasal suture area.

[0766] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0767] Posterosuperior lateral lamina: 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.

[0768] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the central sagittal plane.

[0769] Supramental point: The point on the midline of the lower lip where the greatest concavity occurs between the midpoint of the lower lip and the premental point of the soft tissue.

[0770] Skull Anatomy

[0771] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0772] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0773] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the orbit. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral border.

[0774] 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.

[0775] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the depression at the top of the bridge of the nose.

[0776] Occipital bone: The occipital bone is located on the back and lower part of the skull. It includes the foramen magnum, an oval-shaped opening through which the cranial cavity connects to the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0777] The eye socket is the bony cavity in the skull that houses the eyeball.

[0778] Parietal bone: The parietal bone is the top and sides of the skull when they are joined together.

[0779] 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.

[0780] Cheekbones: The face consists of two cheekbones, which are located on the upper side of the face and form the protrusions of the cheeks.

[0781] 5.9.2.2 Anatomy of the Respiratory System

[0782] 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.

[0783] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0784] 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.

[0785] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located in the middle of the face above and behind the nose. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular "concha") or nasal turbinates. The front of the nasal cavity is the nose, while the back connects to the nasopharynx via the internal nasal openings.

[0786] Pharynx: The part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0787] 5.9.3 Patient Interface

[0788] 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.

[0789] Headgear: A headgear is a form of positioning and stabilizing structure designed to hold a device (such as a mask) on the head.

[0790] Inflation chamber: The mask inflation chamber is considered to refer to a portion of the patient interface having walls that at least partially enclose a volume of space, which, in use, contains air pressurized therein to above atmospheric pressure. An outer shell may form part of the wall of the mask inflation chamber.

[0791] Sealing: can be the noun form referring to a structure ("seal") or the verb form referring to an effect ("seal"). Two elements can be constructed and / or arranged to "seal" or to achieve a "seal" between them without requiring a separate "seal" element itself.

[0792] Ventilation port (noun): A structure that allows airflow from inside the mask or tubing 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.

[0793] 5.10 Other Notes

[0794] This patent document contains a portion of copyrighted material. The copyright holder does not object to any fax reproduction of the patent document or patent disclosure appearing in the patent office's patent documents or records, but otherwise reserves all copyright rights.

[0795] Unless the context clearly indicates otherwise and where a range of values ​​is provided, it should be understood that every intermediate value between the upper and lower limits of the range (to one-tenth of the lower limit unit), and any other stated or intermediate value within the stated range, is included within this technology. The upper and lower limits of these intermediate ranges (which may be independently included in the intermediate range) are also included within this technology, but are subject to any express exclusions within the stated range. Where the stated range includes one or both of these limitations, the range excluding any one or both of those included limitations is also included within this technology.

[0796] Furthermore, where one or more values ​​are stated herein as part of the implementation of the technology, it should be understood that, unless otherwise stated, such values ​​may be approximate and may be used to any suitable significant number to the extent that the actual technical implementation allows or requires them.

[0797] Furthermore, as used herein, “approximately,” “basically,” “about,” or any similar terms mean + / - 5-10% of the stated value.

[0798] 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.

[0799] When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise specified, any and all components described herein should be understood as being capable of being manufactured, and therefore can be manufactured together or separately.

[0800] It must be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents, unless the context clearly indicates otherwise.

[0801] 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.

[0802] The terms “comprises” and “comprising” should be understood as referring to each element, component, or step in a non-exclusive manner, indicating the marked element, component, or step that may be present or utilized, or a combination with other unmarked elements, components, or steps.

[0803] The subject headings included in the detailed description are for the reader's convenience only and should not be used to limit the subject matter found throughout the disclosure or claims. Subject headings should not be used to interpret the claims or limit their scope.

[0804] 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 that are not required for practicing the techniques described. 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 shown 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.

[0805] Therefore, it should be understood that various modifications can be made to the exemplary examples and other arrangements can be designed without departing from the spirit and scope of this technology.

Claims

1. A patient interface configured to deliver a flow of breathable gas to a patient for treatment of a respiratory disorder, the patient interface comprising: a plenum chamber pressurisable, when in use, to a therapeutic pressure of at least 4 cmH20 above ambient pressure throughout a patient’s respiratory cycle, the plenum chamber including: a seal-forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding at least one entrance to the patient’s airways; a positioning and stabilising structure configured to maintain the seal-forming structure in place on the patient’s face when in use; and a forehead cooling system configured to cool the patient’s forehead when in use.

2. The patient interface of claim 1, wherein the forehead cooling system includes a conduit configured to direct a flow of air to the patient’s forehead when in use.

3. The patient interface of claim 3, wherein the flow of air includes at least a portion of the flow of breathable gas.

4. The patient interface of claim 2 or 3, wherein the conduit is connected to the plenum chamber and is configured to direct the flow of air out of the plenum chamber, towards the patient’s forehead.

5. The patient interface of claim 2 or 3, wherein the conduit is connected to an air circuit configured to be connected to a connection port on the patient interface.

6. The patient interface of claim 2 or 3, wherein the conduit is provided in the positioning and stabilising structure.

7. The patient interface of claim 6, wherein a first conduit is fluidly connected to a first side in a region of the positioning and stabilising structure above the patient’s eye.

8. The patient interface of claim 6 or 7, further comprising a second conduit positioned on a second, opposite side in the region of the positioning and stabilising structure above the patient’s eye.

9. The patient interface of claim 8, wherein the first conduit is fluidly connected to the second conduit by a semi-permeable material configured to expel a flow of air to the patient’s forehead.

10. The patient interface of claim 1, wherein the forehead cooling system is positioned to be in contact with the patient’s forehead when in use.

11. The patient interface of claim 10, wherein the forehead cooling system includes a fluid reservoir.

12. The patient interface of claim 11, wherein the fluid reservoir includes any one or more of: water, oil, gel or sodium polyacrylate.

13. The patient interface of claim 11 or 12, further comprising a pump configured to flow fluid within the fluid reservoir.

14. The patient interface of claim 10, wherein the forehead cooling system includes a thermoelectric cooler.

15. The patient interface of any one of the preceding claims, wherein the forehead cooling system includes a thermal interface material positioned to be in contact with the patient’s forehead when in use.

16. The patient interface of any one of the preceding claims, wherein the forehead cooling system comprises a heat sink.

17. A method of controlling a forehead cooling system, the method comprising the steps of: A) monitoring a temperature of a patient’s forehead; B) activating a forehead cooler if the forehead temperature is above a first predetermined threshold; C) deactivating the forehead cooler if the forehead temperature is below a second predetermined threshold.

18. The method of claim 17, wherein the forehead cooler comprises a thermoelectric cooler.

19. The method of claims 17-18, wherein the first predetermined threshold is between 20 degrees Celsius and 30 degrees Celsius.

20. The method of any one of claims 17-19, wherein the first predetermined threshold is substantially equal to 25 degrees Celsius.

21. The method of claims 17-20, wherein the second predetermined threshold is between 15 degrees Celsius and 20 degrees Celsius.

22. The method of any one of claims 17-21, wherein the second predetermined threshold is substantially equal to 18 degrees Celsius.

23. The method of any one of claims 17-22, wherein the forehead cooler can comprise a first active mode and a second active mode, wherein the first active mode provides a first cooling rate and the second active mode provides a second cooling rate that is less than the first active mode.

24. The method of claim 23, wherein the forehead cooling system is configured to switch from the first active mode to the second active mode when the forehead temperature is below a third predetermined threshold, and to switch from the second active mode to the first active mode when the forehead temperature is above the third predetermined threshold.

25. The method of claim 24, wherein the third predetermined threshold is between 20 degrees and 22 degrees.

26. The method of any one of claims 17-25, wherein the forehead cooling system is only active during a sleep onset period and is inactive when the patient is detected to be asleep.

27. The method of any one of claims 17-26, wherein the forehead cooling system is configured to increase the temperature of the patient’s forehead as part of a wake-up procedure.

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