Forehead cooling system

Abstract

This technology relates to a forehead cooling system configured for use with a patient interface to assist in the treatment of sleep and respiratory disorders. Embodiments of this technology include fluid cooling systems such as air cooling and water cooling. Other embodiments utilize phase change materials and thermoelectric coolers. In some embodiments, the forehead cooling system may be mounted on a positioning and stabilization structure.

Description

Technical Field

[0001] [Cross - Reference to Related Applications] This application claims the priority of Australian Provisional Patent Application No. 2023902322, filed on July 21, 2023, the entire content of which is incorporated herein by reference.

[0002] 2.1 Technical Field This technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory - related diseases. This technology also relates to medical devices or apparatuses and their use.

Background Art

[0003] 2.2 Description of Related Technologies 2.2.1 The Human Respiratory System and Its Diseases

[0004] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0005] These airways include a series of bronchial tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to move from inhaled air to venous blood and carbon dioxide to move in the opposite direction. The trachea divides into the right and left main bronchi, which further divide and ultimately become terminal bronchioles. The bronchioles constitute the airways for conduction and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory region. See "Respiratory Physiology", 9th Edition, published in 2012 by John B. West, Lippincott Williams & Wilkins.

[0006] There are various respiratory diseases. Certain diseases can be characterized by specific events, such as apnea, hypopnea, and hyperpnea.

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

[0008] Obstructive sleep apnea syndrome (OSA), a type of sleep-disordered breathing (SDB), is characterized by events involving the closure or obstruction of the upper airway during sleep. This results from an abnormal narrowing of the upper airway combined with a normal decrease in muscle tone in the areas of the tongue, soft palate, and posterior oropharynx during sleep. As a result, affected individuals experience respiratory cessation typically lasting 30 to 120 seconds, sometimes as many as 200 to 300 times per night. Consequently, excessive daytime sleepiness is often present, and it can contribute to cardiovascular disease and brain injury. This syndrome is a common disorder, particularly prevalent in overweight middle-aged men, although patients may not be aware of any symptoms (see, for example, U.S. Patent No. 4,944,310 (Sullivan)).

[0009] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, characterized by alternating, cyclical increases and decreases in ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CSR is associated with repeated awakenings from sleep, leading to severe sleep disturbances, increased sympathetic nervous system activity, and increased afterload (see, for example, U.S. Patent No. 6,532,959 (Berthon-Jones)).

[0010] Respiratory failure is a general term for 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 encompass some or all of the following conditions:

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

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

[0013] Chronic obstructive pulmonary disease (COPD) encompasses a group of lower respiratory tract diseases that share certain common characteristics. These include increased resistance to airflow, prolonged expiratory phase of breathing, and reduced normal elasticity in the lungs. 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 shortness of breath on exertion, chronic cough, and sputum production.

[0014] Neuromuscular diseases (NMDs) are a broad term encompassing numerous illnesses and diseases that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of walking ability, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular diseases can be classified into rapidly progressive and slowly progressive types: (i) rapidly progressive diseases: 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 teenagers); (ii) variable or slowly progressive diseases: characterized by muscle damage that worsens over years and only slightly shorten life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of NMD respiratory failure include worsening general weakness, dysphagia, shortness of breath during exertion and at rest, fatigue, drowsiness, morning headache, and difficulty with attention and emotional changes.

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

[0016] A range of therapies have been used to treat or improve this condition. Furthermore, individuals who are otherwise healthy may utilize such therapies to prevent the onset of respiratory illness. However, these therapies have many shortcomings. 2.2.2 Therapy

[0017] A variety of respiratory therapies, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), have been used to treat one or more of the aforementioned respiratory disorders. 2.2.2.1 Respiratory pressure therapy

[0018] Respiratory pressure therapy (which differs from negative pressure therapy, such as tank ventilators or positive / negative pressure external ventilators (cuirass)) involves supplying air to the airway entrance at a controlled target pressure that is nominally positive pressure relative to the atmosphere throughout the patient's entire respiratory cycle.

[0019] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action involves, for example, the continuous positive airway pressure therapy acting as an air splint by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, thereby preventing upper airway obstruction. Because CPAP therapy for OSA is sometimes optional, patients may choose not to undergo such therapy for one or more reasons, such as discomfort, difficulty of use, high cost, or unattractiveness of the device.

[0020] Non-invasive ventilation (NIV) provides ventilatory support to a patient via the upper airway to assist the patient's breathing and / or maintain adequate oxygen levels in the body by completing some or all of the respiratory work. Ventilation support is provided through a non-invasive patient interface. NIV is used in the treatment of OHS, COPD, NMD, and forms of CSR and respiratory failure such as chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

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

[0022] Not all respiratory therapies are intended to deliver a prescribed therapeutic pressure. Some respiratory therapies aim to deliver a prescribed tidal volume by delivering an inspiratory flow profile over a target duration, and in some cases superimposed with positive baseline pressure. In other cases, the patient's airway interface is "open" (unsealed), and the respiratory therapy may supplement only the patient's own spontaneous breathing with a controlled or concentrated gas flow. For example, high-flow therapy (HFT) delivers a continuous flow of heated, humidified air at a "therapeutic flow rate" that can be maintained nearly constant throughout the entire respiratory cycle at the airway inlet through an unsealed or open patient interface. The therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT is used for the treatment of OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow 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 called dead space therapy (DST). Other advantages include improved thermal and humidification effects (perhaps due to secretion control), as well as a gradual increase in airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate may follow a profile that fluctuates throughout the respiratory cycle.

[0023] Another form of flow therapy is long-term oxygen therapy (LTOT) or oxygen supplementation therapy. The physician may specify a continuous flow of oxygen-enriched air at a specified oxygen concentration (oxygen fraction of ambient air, 21% to 100%) to be delivered to the patient's airways at a specified flow rate (e.g., 1 liter / minute (LPM), 2 LPM, 3 LPM, etc.). 2.2.3 Respiratory Therapy System

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

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

[0026] The patient interface can be used to connect the breathing apparatus to the wearer, for example, by providing a flow of air to the entrance to the airway. The flow of air can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can, for example, promote gas delivery at a pressure sufficiently different from the ambient pressure, such as a positive pressure of about 10 cmH2O relative to the ambient pressure, by forming a seal with a certain area of the patient's face, and can effectively perform the therapy. In the case of other forms of therapy such as oxygen delivery, the patient interface may not include a seal sufficient to promote the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O. In the case of flow therapy such as nasal HFT, the patient interface delivers air to the nostrils and is configured to avoid a particularly complete seal. An example of such a patient interface is a nasal cannula.

[0027] Certain other mask systems may be functionally inappropriate in this field. For example, a purely decorative mask may not be able to maintain an appropriate pressure. A mask system used in underwater swimming or diving protects against water intrusion from higher external pressures but can be configured not to maintain the internal air at a pressure higher than the ambient.

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

[0029] In certain masks, it can be uncomfortable or impractical in this technology when the patient has to insert a part of the mask structure into the mouth and create and maintain a sealed state through the lips.

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

[0031] Certain masks may trigger claustrophobia, anxiety, and / or make individuals feel excessively conspicuous.

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

[0033] Due to these challenges, some masks, especially when worn for extended periods or when the patient is unfamiliar with the system, have problems such as being uncomfortably conspicuous, aesthetically undesirable, expensive, poorly fitting, difficult to use, and causing discomfort. Incorrect mask dimensions can lead to decreased compliance, reduced comfort, and worsened patient outcomes. Masks designed specifically for pilots, masks designed as part of personal protective equipment (such as filter masks), scuba masks, or masks designed for administering anesthetics may be durable for their intended use, but even so, such masks can become uncomfortable when worn for extended periods, such as several hours. This discomfort can lead to decreased patient compliance with therapy.

[0034] CPAP therapy is highly effective in treating certain respiratory conditions, provided that patients adhere to the therapy regimen. Patients may not follow the treatment if the mask is uncomfortable or difficult to use. Since patients are often advised to wash their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may be unable to clean it, which can affect their compliance.

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

[0036] For these reasons, patient interfaces that deliver CPAP during sleep occupy a unique domain. 2.2.3.1.1 Seal-forming structure

[0037] The patient interface may include a seal-forming structure. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0038] Patient interfaces can be partially characterized according to their design intent to engage a seal-forming structure with the face during use. In one form of a patient interface, the seal-forming structure may include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of a patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and the nasal bridge region of the face. In one form of a patient interface, the seal-forming structure may include an element that surrounds the mouth region during use by forming a seal, for example, on the lower lip region of the face. In one form of a patient interface, the seal-forming structure may include a single element that surrounds both the nostril and mouth regions during use. These various types of patient interfaces may be known by a variety of names by their manufacturers, such as nasal masks, full-face masks, nasal pillows, nasal puffs, and mouth-nasal masks.

[0039] For example, due to the different shapes, structures, variability, and sensitive areas of a patient's face, a seal-forming structure that may be effective in one area of ​​the patient's face may be unsuitable in another. For instance, a seal on swimming goggles that covers the patient's forehead may be unsuitable for use over the patient's nose.

[0040] A particular seal-forming structure can be designed for mass production so that one design fits a wide range of different face shapes and sizes, and is comfortable and effective. To form a seal, one or both the patient's face shape and the mass-produced patient interface seal-forming structure must be adapted to a certain extent, even if there is some mismatch between them.

[0041] A certain type of seal-forming structure extends around the patient interface and is designed to engage with the patient's face relative to it when force is applied to the patient interface, thereby sealing the patient's face. The seal-forming structure may include an air or fluid-filled cushion, or it may include a formed or formed surface of an elastic seal element made of an elastomer such as rubber. In this type of seal-forming structure, if the fit is insufficient, a gap exists between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0042] Another type of seal-forming structure uses a thin flap seal positioned around the perimeter of the mask to provide a self-airtight seal against the patient's face when positive pressure is applied inside the mask. Similar to the previously mentioned types of seal-forming structures, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or leakage may occur from the mask. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or buckle during use, potentially causing leakage.

[0043] Another type of seal-forming structure may include a friction-fitting element, for example, a friction-fitting element. However, some patients may find this uncomfortable.

[0044] Another form of seal-forming structure may use an adhesive portion to obtain a seal. Some patients may find it inconvenient to constantly attach or remove the adhesive portion from their face.

[0045] A series of patient interface seal formation structures are disclosed in patent applications WO 1998 / 004310, WO 2006 / 074513, and WO 2010 / 135785.

[0046] One form of nasal pillow is found in the Adam circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.), which is assigned to Puritan-Bennett Corporation.

[0047] ResMed Inc. manufactures products incorporating nasal pillows, including the SWIFT® nasal pillow mask, SWIFT® II nasal pillow mask, SWIFT® LT nasal pillow mask, SWIFT® FX nasal pillow mask, and MIRAGE LIBERTY® full-face mask. The following patent applications describe embodiments of nose pillow masks: International Patent Application WO2004 / 073778 (in particular describing embodiments of the SWIFT® nose pillow), U.S. Patent Application 2009 / 0044808 (in particular describing embodiments of the SWIFT® LT nose pillow), International Patent Applications WO2005 / 063328 and WO2006 / 130903 (in particular describing embodiments of the MIRAGE LIBERTY full-face mask), and International Patent Application WO2009 / 052560 (in particular describing embodiments of the SWIFT® FX nose pillow). 2.2.3.1.2 Positioning and stabilization structure

[0048] The seal-forming structure of the patient interface used in positive pressure air therapy is subjected to a corresponding force from the air pressure that interferes with the seal. Therefore, various techniques are used to position the seal-forming structure and maintain a seal relationship with the appropriate part of the face. When comparing various positioning and stabilization techniques, several factors can be considered. These include the effectiveness of the technique in maintaining the seal-forming structure in place and sealing it with the face during patient interface use, the comfort of the interface for the patient, whether the patient feels invaded and / or claustrophobic when wearing the patient interface, and its aesthetic appeal.

[0049] One technique involves the use of adhesives; see, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, the use of adhesives may be unpleasant for some people.

[0050] In other technologies, one or more straps and / or stabilization harnesses are used. Such harnesses often suffer from one or more problems, including poor fit, bulkiness, discomfort, and cumbersome handling. 2.2.3.1.3 Pressurized air conduit

[0051] In one type of treatment system, a flow of pressurized air is supplied to the patient interface through a conduit in an air circuit that is fluidly connected to the patient interface at a position in front of the patient's face when the patient interface is positioned on the patient's face during use. This conduit may extend forward so as to move away from the patient interface and away from the patient's face. 2.2.3.1.4 Pressurized air conduits for positioning and stabilizing seal-molded structures

[0052] Another type of treatment system includes a patient interface, and a tube that delivers pressurized air to the patient's airway is also used as part of the headgear to position and stabilize the sealing portion of this patient interface in the appropriate part of the patient's face. This type of patient interface is sometimes referred to as having a “conduit-type headgear” or “headgear tube.” Such a patient interface allows a conduit in an air circuit that supplies a flow of pressurized air from a respiratory pressure therapy (RPT) device to be connected to the patient interface at a position other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication 2007 / 0246043, which is incorporated herein by reference, and the conduit is connected to a tube in the patient interface through a port positioned above the patient's head when in use.

[0053] The patient interface incorporating the headgear tube should ideally be comfortable for the patient to wear for extended periods during sleep, provide a highly airtight and stable seal to the patient's face, and be adaptable to various patient head shapes and sizes. 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0054] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the above-mentioned therapies, for example, by operating the device to generate an airflow that can be delivered to the airway interface. The airflow can be pressure-controlled (in the case of respiratory pressure therapy) or flow-controlled (in the case of flow therapy such as HFT). Therefore, RPT devices can also function as flow therapy devices. Examples of RPT devices include PAP devices and ventilators.

[0055] Pneumatic generators are well known in a wide range of applications (e.g., industrial-scale ventilation systems). However, pneumatic generators for medical applications have specific requirements that are not met by more general-purpose pneumatic generators (e.g., reliability, size, and weight requirements for medical devices). In addition, even devices designed for medical treatment may have deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0056] One example of a specific requirement for a particular RPT device is acoustic noise.

[0057] [Table 1]

[0058] One known RPT device used in the treatment of sleep-disordered breathing is the S9 sleep therapy system from ResMed Inc. Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed STella® series of adult and pediatric ventilators) can treat a number of conditions, including, but not limited to, NMD, OHS, and COPD, by providing assistance for invasive and non-invasive, independent ventilation in a variety of patients.

[0059] The ResMed Elisee® 150 ventilator and the ResMed VSIII® ventilator can provide invasive and non-invasive dependent ventilation assistance suitable for adult or pediatric patients for the treatment of multiple diseases. These ventilators provide volumetric ventilation and pneumatic ventilation modes via single-limb or double-limb circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) and are configured to supply airflow to the patient's airway. In some cases, the airflow may be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0060] Device designers may be presented with countless options. Since design criteria are often contradictory, a particular design choice is never routine or inevitable. Furthermore, the comfort and effectiveness of a particular aspect can be highly sensitive to even slight changes in one or more parameters. 2.2.3.3 Air Circuit

[0061] An air circuit is a conduit or tube constructed and positioned so that, during use, airflow moves between two components of a respiratory therapy system (e.g., an RPT device and a patient interface). In some cases, there may be separate limbs of the air circuit for inspiration and expiration. In other cases, a single-limb air circuit is used for both inspiration and expiration. 2.2.3.4 Humidifier

[0062] Delivering airflow without humidification can lead to airway dryness. When a humidifier is used with the RPT device and patient interface, humidifying gas is produced, minimizing nasal mucosal dryness and increasing patient airway comfort. Additionally, in cooler climates, warm air applied to the facial area within and around the patient interface is generally more comfortable than cold air. 2.2.3.5 Ventilation Technology

[0063] Some forms of treatment systems may include a ventilator for washing out exhaled carbon dioxide. This ventilator may allow gas to flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings).

[0064] This ventilation section may include an orifice, through which gas can flow when the mask is in use. Many such ventilation sections generate noise. In other cases, they may become blocked during use, resulting in insufficient airflow. In some ventilation sections, noise or concentrated airflow may disrupt the sleep of 1100 people sharing a bed with 1000 patients.

[0065] ResMed Inc. has developed numerous improved mask ventilation technologies; see, for example, International Patent Application Publication No. 1998 / 034665, International Patent Application Publication No. 2000 / 078381, U.S. Patent No. 6,581,594, U.S. Patent Application Publication No. 2009 / 0050156, and U.S. Patent Application Publication No. 2009 / 0044808.

[0066] [Table 2]

[0067] [Table 3] [Overview of the project]

[0068] This technology relates to providing medical devices used in screening, diagnosing, monitoring, improving, treating, or preventing respiratory diseases, wherein these medical devices have one or more of the following advantages: improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0069] A first aspect of this technology relates to a device used for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0070] Another aspect of this technology relates to a method used in screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0071] One particular embodiment of this technology is to provide a method and / or apparatus for improving respiratory therapy compliance in patients.

[0072] One embodiment of this technology comprises a positioning and stabilizing structure configured to provide a force that holds a seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes at least one strap.

[0073] One embodiment of this technology includes a patient interface comprising a plenum chamber, a seal-forming structure, and a positioning and stabilizing structure.

[0074] One aspect of this technology comprises a patient interface including a plenum chamber capable of pressurizing to a therapeutic pressure at least 4 cmH2O higher than ambient air pressure. The plenum chamber includes at least one plenum chamber inlet port having a size and structure that accepts an airflow at therapeutic pressure for the patient to breathe. The patient interface includes a seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway. The seal-forming structure has holes in it so that the airflow at the therapeutic pressure is directed at at least the entrance to the patient's nostrils. The seal-forming structure is constructed and positioned to maintain therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use. The patient interface also includes a positioning and stabilizing structure to provide force for holding the seal-forming structure in a therapeutically effective position on the patient's head.

[0075] Another aspect of one form of this technology is a set of modular elements that can be interconnected to form different types of patient interfaces.

[0076] In one configuration, each module element has at least two versions or forms. These versions or forms can be used interchangeably to form various modular assemblies.

[0077] One embodiment of the present technology includes a patient interface configured to deliver a breathable gas stream to a patient for the treatment of a respiratory disease, the patient interface including a plenum chamber that can be pressurized to a therapeutic pressure at least 4 cmH2O higher than ambient atmospheric pressure throughout the patient's entire respiratory cycle during use, the plenum chamber including a seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding at least one entrance to the patient's airway, a positioning and stabilizing structure configured to hold the seal-forming structure at the position of the patient's face during use, and a forehead cooling system configured to cool the patient's forehead during use.

[0078] In embodiments of this technology, the patient interface may be configured to be connected to an air circuit to receive a flow of breathable gas from a flow generator.

[0079] In embodiments of this technology, the forehead cooling system may be configured to direct a portion of the breathable gas flow to the patient's forehead when in use.

[0080] In embodiments of this technology, the forehead cooling system may be a conduit configured to direct a portion of the breathable gas flow to the patient's forehead when in use.

[0081] In embodiments of this technology, the conduit may be configured to be fluidly connected to a plenum chamber and to guide breathable gas from the plenum chamber toward the patient's forehead.

[0082] In embodiments of this technology, the conduit may be connected to an air circuit configured to connect to a connection port on the patient interface.

[0083] In embodiments of this technology, the conduit may be provided within a positioning and stabilization structure.

[0084] In embodiments of this technology, the first conduit can be fluidly connected to the first side of the positioning and stabilizing structure in a region above the patient's eyeball.

[0085] In embodiments of this technology, the second conduit can be positioned on the second opposing side of the positioning and stabilizing structure in a region above the patient's eyeball.

[0086] In embodiments of this technology, the first conduit may be fluidly connected to the second conduit by a semipermeable material configured to ventilate a breathable gas flow to the patient's forehead.

[0087] In embodiments of this technology, the forehead cooling system may be positioned to contact the patient's forehead during use.

[0088] In embodiments of this technology, the forehead cooling system may include a fluid reservoir.

[0089] In the embodiments of this technology, the fluid reservoir may contain one or more of the following: water, oil, gel, or sodium polyacrylate.

[0090] In embodiments of this technology, the patient interface may further include a pump configured to generate a fluid flow within a fluid reservoir.

[0091] In embodiments of this technology, the forehead cooling system may include a thermoelectric cooler.

[0092] In embodiments of this technology, the forehead cooling system may include a thermal interface material positioned to contact the patient's forehead during use.

[0093] In embodiments of this technology, the forehead cooling system may include a heat sink.

[0094] Another aspect of a certain form of the present technology is a method for controlling a forehead cooling system, the method comprising: A) monitoring the temperature of a patient's forehead; B) activating a forehead cooler if the temperature of the forehead exceeds a first predetermined threshold; and C) deactivating the forehead cooler if the temperature of the forehead is below a second predetermined threshold.

[0095] In the embodiment of this technology, the first predetermined threshold can be 20 to 30°C.

[0096] In the embodiment of this technology, the first predetermined threshold may be substantially equal to 25°C.

[0097] In the embodiment of this technology, the second predetermined threshold can be 15 to 20°C.

[0098] In embodiments of this technology, the second predetermined threshold may be substantially equal to 18°C.

[0099] In embodiments of this technology, the frontal cooler may include a first active mode and a second active mode, the first active mode providing a first cooling rate, and the second active mode providing a second cooling rate lower than that of the first active mode.

[0100] In an embodiment of this technology, the forehead cooling system may be configured to switch from a first active mode to a 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 exceeds the third predetermined threshold.

[0101] In the embodiment of this technology, the third predetermined threshold can be 20 to 22 degrees.

[0102] In this embodiment of the technology, the forehead cooling system can be activated only during the sleep onset phase and becomes inactive when the patient is detected to be asleep.

[0103] In embodiments of this technology, the forehead cooling system may be configured to raise the temperature of the patient's forehead as part of an awakening routine.

[0104] Another aspect of one embodiment of this technology is a patient interface configured to deliver a breathable gas stream to a patient for the treatment of a respiratory disease, the patient interface comprising a plenum chamber pressurized to a therapeutic pressure at least 4 cmH2O higher than ambient atmospheric pressure throughout the patient's entire respiratory cycle during use, the plenum chamber comprising a seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding at least one inlet to the patient's airway, a positioning and stabilizing structure configured to hold the seal-forming structure at the position of the patient's face during use, and a ventilation section configured to ventilate gas from the plenum chamber to the surroundings. This ventilation unit is fluidically connected to a conduit, which directs the ventilation gas through the conduit towards the forehead area of ​​the patient in use.

[0105] In the embodiment, the conduit may be adjustablely connected to the ventilation unit to control the amount and / or direction of the ventilation gas directed towards the patient's forehead region.

[0106] In the embodiment, the patient interface may include a shell made of a material having higher rigidity than the seal-forming structure, and the conduit is fluidly connected to the shell.

[0107] In one embodiment, the conduit may be formed into a shell. In another embodiment, the conduit may be attached to a shell, for example, in a detachable manner.

[0108] In the embodiment, the conduit may be connected to a seal-forming structure.

[0109] In the embodiment, the ventilation unit may include a central component and an outer housing, the central component being rotatable relative to the outer housing and capable of adjusting the airflow directed towards the patient's forehead.

[0110] In another embodiment of one form of this technology, an air circuit is provided which is configured to deliver a breathable gas flow to a patient interface for the treatment of a respiratory disease, and this air circuit is An air tube configured to receive a breathable gas flow, comprising a first end configured to connect to a flow generator and a second end configured to connect to a patient interface, At least one ventilation unit configured to discharge at least a portion of the breathable gas and / or gas stream exhaled by the patient during use into the surrounding environment, It includes at least one conduit configured to direct the expelled gas toward the patient's forehead during use.

[0111] In the embodiment, the first end of the air tube may include a connector or cuff configured to assist in connecting the air circuit to a flow generator.

[0112] In the embodiment, the second end of the air tube may include a connector or cuff to assist in connecting the air circuit to the flow generator.

[0113] In the embodiment, the second end of the air tube may include a separation structure. For example, the separation structure may have a patient interface side and an air tube side.

[0114] In the embodiment, the conduit may be connected to the patient interface side of the separation structure.

[0115] In the embodiment, the air circuit may include one or more heating elements configured to heat the air in the air tube.

[0116] In the embodiment, the heating element may be a heated wire circuit and may include one or more transducers, such as a temperature sensor.

[0117] In the embodiment, the heated wire circuit may be wound helically around the longitudinal axis of the air circuit.

[0118] According to another aspect of one embodiment of the present technology, a ventilation unit is provided for a respiratory pressure therapy system, which is configured to deliver a flow of pressurized breathable gas to the airway of a patient in use, the ventilation unit is configured to allow at least a portion of the pressurized breathable gas to pass from the respiratory pressure therapy system, the ventilation unit is fluidically coupled to a conduit, thereby directing the portion of the pressurized breathable gas that has passed through the ventilation unit toward the patient's forehead.

[0119] In the embodiment, the ventilation unit may be configured to allow at least a portion of the pressurized breathable gas to pass from the plenum chamber of the patient interface to the surrounding environment.

[0120] In the embodiment, the ventilation unit may be configured to allow at least a portion of the gas exhaled by the patient to pass from the plenum chamber to the surrounding environment.

[0121] In the embodiment, the ventilation unit may be adjustable to control the amount of pressurized, breathable gas directed toward the patient's forehead.

[0122] In the embodiment, the ventilation unit may include a central component and an outer housing, the central component being rotatable relative to the outer housing and capable of adjusting the airflow directed towards the patient's forehead.

[0123] In the embodiment, the conduit can be attached to the ventilation section.

[0124] According to another aspect of one embodiment of the present technology, a forehead cooling system is provided, which includes a positioning and stabilizing structure configured to hold a forehead cooler in contact with the user's forehead.

[0125] In the embodiment, the frontal cooler may be a thermoelectric cooler.

[0126] In the embodiment, the frontal cooler may be a fluid cooler.

[0127] In the embodiment, the forehead cooling system may further include a pump that circulates a fluid through the forehead cooling device. For example, the fluid may be a liquid or a gas.

[0128] In the embodiment, the forehead cooler may be configured to direct airflow to the patient's forehead.

[0129] In the embodiment, the forehead cooling system may include one or more sensors configured to measure the user's moisture level, temperature, heart rate, or provide electroencephalogram (EEG) information.

[0130] In the embodiment, the forehead cooling system may be configured to actively cool the user's forehead to a preset temperature.

[0131] In this embodiment, the forehead cooling system may be configured to detect when the user falls asleep.

[0132] In the embodiment, the forehead cooling system may be configured to reduce cooling of the forehead when sleep is detected.

[0133] In the embodiment, the forehead cooling system may be configured to notify the user when it is time to wake up. For example, the forehead cooling system may raise the temperature of the user's forehead when it is time to wake up.

[0134] According to another aspect of one embodiment of this technology, a method for controlling a forehead cooling system is provided, and this method is A) A step of acquiring patient information from one or more sensors, B) A step of comparing the acquired information with one or more predefined rules, C) The step of executing an action if the rule conditions are met.

[0135] In the embodiment, the method may further include the step of determining whether the patient is awake or asleep.

[0136] In one embodiment, predefined rules may include whether the patient is awake and whether the forehead temperature is above, within, or below a predefined threshold. In another embodiment, predefined rules may include whether the patient is asleep and whether the forehead cooling system should be deactivated, activated in a low-power state, or configured to target a predefined sleep temperature range.

[0137] In the embodiment, the actions performed include one or more of the following: controlling the temperature of the patient's forehead, generating auditory stimuli, changing the fluid flow rate in the cooling system, and activating or deactivating the cooling system.

[0138] Another embodiment of the technology includes a patient interface configured to deliver a breathable gas stream to a patient for the treatment of a respiratory disease, the patient interface comprising a plenum chamber pressurized to a therapeutic pressure at least 4 cmH2O higher than ambient atmospheric pressure throughout the patient's entire respiratory cycle during use, the plenum chamber comprising a seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding at least one entrance to the patient's airway, a positioning and stabilizing structure configured to hold the seal-forming structure at the position of the patient's face during use, and a forehead cooling system configured to cool the patient's forehead during use, and a processor configured to detect the patient's sleep state, the forehead cooling system being controlled according to the detected sleep state of the patient.

[0139] Another aspect of one form of this technology is a patient interface molded or otherwise constructed together with a peripheral shape that complements the shape of the intended wearer.

[0140] One embodiment of this technology is a method for manufacturing an apparatus.

[0141] Another aspect of one embodiment of this technology is a method for assembling a modular system, the method comprising selecting a positioning and stabilizing structure and connecting the positioning and stabilizing structure to either a first cushion or a second cushion.

[0142] One particular form of this technology is a medical device that is easy to use for, for example, a person who has not received medical training, is not very dexterous, lacks insight, or has limited experience using this type of medical device.

[0143] One embodiment of this technology is, for example, a portable RPT device that can be carried by the user at the user's home.

[0144] One embodiment of this technology is a patient interface that can be cleaned at the patient's home with, for example, soapy water, without the need for special cleaning equipment. Another embodiment of this technology is a humidifier tank that can be cleaned at the patient's home with, for example, soapy water, without the need for special cleaning equipment.

[0145] The methods, systems, devices, and apparatus described may be implemented to improve the functionality of processors, such as dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the above methods, systems, devices, and apparatus can provide improvements in the field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0146] Of course, some aspects of this technology may form subordinate aspects of this technology. Furthermore, sub-aspects and / or various aspects of this technology may be combined in various ways to constitute additional aspects or sub-aspects of this technology.

[0147] Other features of this technology will become apparent when considering the information contained in the following detailed description, overview, drawings, and claims. [Brief explanation of the drawing]

[0148] This technology is illustrated in the attached drawings as a non-limiting embodiment. In the drawings, similar reference numerals include the following similar elements. 4.1 Respiratory Therapy System

[0149] [Figure 1A]The system includes a patient 1000 wearing a nasal pillow-shaped patient interface 3000 and receiving positive pressure air from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to patient 1000 through an air circuit 4170. A roommate 1100 is also illustrated. The patient is sleeping in a supine position. [Figure 1B] The system includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives positive-pressure air supplied 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. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000 in the form of a full-face mask that receives positive-pressure air supplied 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. 4.2 Anatomy of the Respiratory System and Face [Figure 2A] This diagram outlines the human respiratory system, including the nostrils and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] This diagram shows the human upper respiratory tract, including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cord folds, esophagus, and trachea. [Figure 2C] This is a frontal view of the face, including several features of the surface anatomical structures, such as the upper lip, upper lip red, lower lip red, lower lip, width of the mouth, medial canthus, nasal wings, nasolabial folds, and corners of the mouth. The superior, inferior, radially medial, and radially lateral directions are also indicated. [Figure 2D] This is a lateral view of the head, including several features of surface anatomical structures, such as the glabella, root of the nose, tip of the nose, subnasal point, upper lip, lower lip, supramenton, nasal ridge, apex of the nasal ala, superior and inferior base of the ear. The superior and inferior, and anterior and posterior directions are also indicated. [Figure 2E]Further lateral view of the head. The approximate locations of the Frankfort horizontal and nasolabial angles are indicated. The coronal plane is also shown. 4.3 Patient Interface [Figure 3A] This shows a patient interface in the form of a nasal mask according to one embodiment of this technology. [Figure 3A-1] This shows the forces acting on the patient interface in Figure 3A during use. [Figure 3Z] This shows a patient interface having a conduit headgear according to one embodiment of this technology. [Figure 3Z-1] This shows the forces acting on the patient interface in Figure 3Z during use. 4.4 RPT Device [Figure 4A] This shows an RPT device relating to one embodiment of this technology. [Figure 4B] This is a schematic diagram of the pneumatic path of an RPT device according to one embodiment of this technology. The upstream and downstream directions are indicated with reference to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items in the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface. 4.5 Humidifier [Figure 5A] An isometric view of a humidifier relating to one embodiment of this technology is shown. [Figure 5B] This shows an isometric view of a humidifier according to one embodiment of this technology, and the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. 4.6 Respiratory waveform [Figure 6A] This shows a typical respiratory waveform model of a human during sleep. 4.7 Modularity [Figure 7A] This shows a perspective view of a patient interface cushion, which is configured to be worn by a patient and delivers pressurized air to the patient's nose and mouth. [Figure 7B] This shows a perspective view of a patient interface cushion that is configured to be worn by a patient and transmits pressurized air to the patient. [Figure 7C]Figure 7A shows a perspective view of a tube that can be used in conjunction with either the cushion in Figure 7A or the cushion in Figure 7B. [Figure 7D] Figure 7A shows a perspective view of a rigid arm that can be used in conjunction with either the cushion in Figure 7A or the cushion in Figure 7B. [Figure 7E] Figure 7A shows a perspective view of a headgear strap that can be used in conjunction with the cushion. [Figure 7F] Figure 7B shows a perspective view of a headgear strap that can be used in conjunction with the cushion. [Figure 7G] Figure 7C shows a front view of a pair of sleeves that are detachably attached to either the tube or the rigid arm shown in Figure 7D. [Figure 7H] Figure 7D shows a front view of the full sleeve that is detachably attached to the rigid arm. [Figure 7I] Figure 7D shows a front perspective view of yet another alternative form of the full sleeve, which is detachably attached to the rigid arm. [Figure 7J] This is a front view of a patient wearing a patient interface with a nasal and oral cushion in a tube-up configuration. [Figure 7K] This is a front view of a patient wearing a patient interface with a nasal and oral cushion in a tube-down configuration. [Figure 7L] This is a front view of a patient wearing a patient interface with a nasal cushion in a tube-up configuration. [Figure 7M] This is a front view of a patient wearing a nasal cushion patient interface in a tube-down configuration. [Figure 7N] Figure 7L is a perspective view of the ventilation section alone. [Figure 7O] Figure 7M is a standalone perspective view of a portion of the air circuit. [Figure 7P] Figure 7P shows how different elements can be combined to form the four different patient interfaces described above. 4.8 Forehead Cooling [Figure 8A] An embodiment of a positioning and stabilization structure 3300, including a patient interface 3000 and a forehead cooling system 2000, is shown. [Figure 8B] A perspective view of an air circuit according to one embodiment of this technology is shown. [Figure 8C] A perspective view of an air circuit according to another embodiment of this technology is shown. [Figure 9] A schematic diagram of a forehead cooling system using fluid is shown. [Figure 10] An embodiment of a respiratory therapy system, including a forehead cooling system, is shown. [Figure 11] This document presents an example of an active cooling system in the form of a thermoelectric cooler, along with an interface for extracting heat from a fluid. [Figure 12A] A block diagram of an air-assisted thermoelectric cooling system is shown. [Figure 12B] This shows one embodiment of a combined PAP therapy system that directs exhausted air toward a forehead cooling system. [Figure 13] This document shows a cooling control state machine according to one embodiment of this technology. [Figure 14] This describes a simultaneous heating and cooling system configured to heat or humidify the breathable gas that the patient should breathe, while simultaneously cooling the patient's forehead. [Figure 15A] This shows one embodiment of an air circuit configured to direct airflow to the patient's forehead. [Figure 15B] Further embodiments of the air circuit, configured to direct airflow to the patient's forehead, are shown. [Figure 15C] An embodiment of a patient interface in use is shown, in which the air circuit is configured to direct airflow to the patient's forehead. [Figure 16A] This document illustrates one embodiment of a cushion module / patient interface that includes a conduit configured to guide airflow to the patient's forehead. [Figure 16B] This document illustrates one embodiment of a cushion module / patient interface that includes an adjustable conduit configured to direct airflow to the patient's forehead. [Figure 16C] Figure 16A shows a rear view of the cushion module / patient interface. [Figure 17A] This shows a front view of a patient interface used in a forehead cooling system according to one embodiment of this technology. [Figure 17B] This shows a front view of a patient interface used in a forehead cooling system according to another embodiment of this technology. [Figure 17C] This shows a front view of a patient interface used in a forehead cooling system according to another embodiment of this technology. [Figure 18A] This shows a front view of a patient interface used in a ventilation unit configured to direct airflow towards the patient's forehead. [Figure 18B] Figure 18A shows a perspective view of the ventilation section. [Figure 18C] Figure 18A shows a perspective view of the central component of the ventilation unit. [Figure 19A] A side view of a patient interface according to another embodiment of this technology is shown. [Figure 19B] This shows a side view of another patient interface relating to another embodiment of this technology. [Figure 20A] A perspective view of a patient interface according to another embodiment of this technology is shown. [Figure 20B] A perspective view of a forehead cooling system according to another embodiment of this technology is shown. [Figure 20C] This shows a top-down view of a forehead cooling system according to another embodiment of this technology. [Figure 21A] This shows a side view of a VR device equipped with a patient interface. [Figure 21B] Figure 21A shows a cross-sectional view of the VR device, cut in the sagittal plane of the patient. [Figure 22A] This diagram illustrates an exemplary system for monitoring sleep and providing insights and / or recommendations, which includes computing devices. [Figure 22B] Figure 22A shows a diagram of the components of an example computing device. [Figure 23] This is a flowchart illustrating the control method for automatic sleep detection and cooling control. [Figure 24] This is one embodiment of a user interface for receiving feedback on sleep ability and / or controlling the operation of one or more forehead cooling systems. [Modes for carrying out the invention]

[0150] Before describing the technology in further detail, please understand that the technology is not limited to the specific examples described herein and is subject to change. Also, please understand that the terms used in this disclosure are intended to illustrate only the specific examples described herein and are not intended to limit them.

[0151] The following description is provided in relation to a variety of embodiments that may share one or more common properties and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these examples may constitute further examples. 5.1 Therapy

[0152] In one embodiment, the technology includes a method for treating respiratory diseases, which involves applying positive pressure to the airway entrance of 1000 patients.

[0153] In a specific example of this technology, a positive pressure air supply is provided to the patient's nasal pathway through one or both nostrils.

[0154] In certain applications of this technology, mouth breathing is restricted, limited, or prevented. 5.2 Respiratory Therapy Systems

[0155] In one embodiment, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may comprise an air circuit 4170 and an RPT device 4000 for supplying airflow to a patient 1000 via a patient interface 3000 or 3800. 5.3 Patient Interface

[0156] As shown in Figure 3A, a non-invasive patient interface 3000 according to one aspect of the present technology includes, as functional aspects, a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a ventilation section 3400, a connection port 3600 in one form for connecting to an air circuit 4170, and a forehead support section 3700. In some embodiments, the functional aspects may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional modes. When in use, the seal-forming structure 3100 is positioned to surround the patient's airway inlet(s) to maintain positive pressure at the patient's airway inlet(s). Thus, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy.

[0157] As shown in Figure 3Z, a non-invasive patient interface 3000 according to another aspect of the present technology includes, in the following functional aspects, a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation section 3400, and a form of connection port 3600 for connecting to an air circuit (e.g., an air circuit 4170 as shown in Figures 1A-1C). The plenum chamber 3200 may be formed from one or more modular components (e.g., a cushion module 3150 integrated with the seal-forming structure 3100) in the sense that they can be replaced with different components, e.g., components of different sizes.

[0158] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, that patient interface may not be suitable for respiratory pressure therapy.

[0159] A patient interface 3000 according to one embodiment of this technology is constructed and arranged to provide a positive pressure higher than the surroundings, for example, an air supply of at least 2, 4, 6, 10, or 20 cmH2O relative to the surroundings. 5.3.1 Seal-forming structure

[0160] In one embodiment of this technology, the seal-forming structure 3100 provides a target seal-forming region and can further provide a cushioning function. The target seal-forming region is the region on the seal-forming structure 3100 where a seal can occur. The region where sealing actually occurs (i.e., the actual seal surface) may vary from patient to patient in a given treatment session depending on a range of factors (e.g., the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0161] In one embodiment, the target seal-forming region is located on the outer surface of the seal-forming structure 3100.

[0162] In a particular form of this technology, the seal-forming structure 3100 is made of a biocompatible material (e.g., silicone rubber).

[0163] The seal-forming structure 3100 related to this technology can be constructed from a soft, flexible, and elastic material (for example, silicon).

[0164] In a particular embodiment of this technology, a system is provided comprising two or more seal-forming structures 3100, each seal-forming structure 3100 configured to accommodate different size and / or shape ranges. For example, the system may include one form of seal-forming structure 3100 suitable for large heads rather than small heads, and another form suitable for small heads rather than large heads. 5.3.1.1 Sealing mechanism

[0165] In one embodiment, the seal-forming structure includes a sealing flange that uses a pressure-assisted sealing mechanism. During use, the sealing flange can readily respond to the positive system pressure within the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism may work in conjunction with elastic tension in the positioning and stabilizing structure.

[0166] In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than approximately 1 mm (e.g., approximately 0.25 mm to approximately 0.45 mm), which extends around the perimeter length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is positioned between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of its perimeter length. The support flange is or includes a spring-like element and functions to support the sealing flange so as not to buckle during use.

[0167] In one embodiment, the seal-forming structure may include a compression sealing portion or a gasket sealing portion. During use, the compression sealing portion or gasket sealing portion is constructed and positioned so that it is compressed, for example, due to elastic tension in the positioning and stabilizing structure.

[0168] In one embodiment, the seal-forming structure includes a tensioning portion. During use, the tensioning portion is held under tension by, for example, an adjacent region of the sealing flange.

[0169] In one embodiment, the seal-forming structure includes a region having an adhesive surface or bonding surface.

[0170] In certain embodiments of this technology, the seal-forming structure may include one or more of the following: a pressure-assisted sealing flange, a compression sealing section, a gasket sealing section, a tension section, and a section having an adhesive or bonding surface. 5.3.1.2 Nasal bridge or ridge area

[0171] In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the nasal bridge region or nasal ridge region of the patient's face when in use.

[0172] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the nasal bridge region or nasal ridge region of the patient's face when in use. 5.3.1.3 Upper lip area

[0173] In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal when in use on the upper lip region (i.e., the upper lip) of the patient's face.

[0174] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the upper lip area of ​​the patient's face when in use. 5.3.1.4 Jaw region

[0175] In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the jaw region of the patient's face when in use.

[0176] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the jaw area of ​​the patient's face when in use. 5.3.1.5 Frontal Area

[0177] In one embodiment, the seal-forming structure forms a seal on the forehead area of ​​the patient's face when the seal is in use. In this embodiment, the plenum chamber may cover the eye when in use. 5.3.1.6 Nasal pillow

[0178] In one embodiment, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each of which is constructed and positioned to form a seal with each nostril of the patient's nose.

[0179] A nasal pillow according to one aspect of this technology includes a frustocone, at least a portion of which forms a seal on the underside of the patient's nose; a handle; and a flexible region connecting the lower part of the frustocone to the handle. Furthermore, the structure to which the nasal pillow of this technology is connected includes a flexible region adjacent to the base of the handle. The flexible regions work together to create a universal joint structure that allows relative movement of both displacement and angle between the frustocone and the structure to which the nasal pillow is connected. For example, the frustocone can be displaced axially toward the structure to which the handle is connected. 5.3.1.7 Nasal Mask

[0180] In one embodiment, the patient interface 3000 includes a seal-forming structure 3100 configured to seal around the entrance to the patient's nasal airway but not around the patient's mouth. The seal-forming structure 3100 may be configured to seal the patient's upper lip. The patient interface 3000 may not cover the patient's mouth. The patient interface 3000 may deliver air or breathable gas to the patient's two nostrils rather than to the oral cavity. This type of patient interface may be identified as a nasal mask only.

[0181] The nasal mask-only form of this technology is the form conventionally considered to be a "nasal mask" and has a seal-forming structure 3100 configured to seal around the nose and above the nasal bridge of the patient's face. The nasal mask may also be triangular in shape. In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, when in use, forms a seal with the upper lip region (e.g., the upper lip), at least a portion of the nasal ridge above the patient's nasal bridge or anterior nostrils, and the patient's face on each side of the patient's nose (e.g., the nasolabial folds near the patient). The patient interface 3000 shown in Figure 1B has this type of seal-forming structure 3100. The patient interface 3000 can supply air or breathable gas to both nostrils of the patient 1000 through a single opening.

[0182] Another form of nasal mask may seal around the area below the patient's nose without engaging with the patient's nasal bridge. For example, this type of patient interface 3000 may be identified as a “nasal cradle” mask, and the seal-forming structure 3100 may be identified as a “nasal cradle cushion.” In one embodiment, for example as shown in Figure 3Z, the seal-forming structure 3100 is configured to form a seal with the underside of the nose around the nostrils when in use. The seal-forming structure 3100 may be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including the underside and / or anterior surface of the nasal tip region of the patient's nose and the patient's nasal wings. The seal-forming structure 3100 may seal the patient's upper lip. The shape of the seal-forming structure 3100 may be configured to conform to the underside of the patient's nose, or to adhere closely to the underside of the patient's nose, and further, not to contact the nasal bridge region of the patient's nose or any part above the anterior part of the patient's nose. In one embodiment of the nasal cradle cushion, the seal-forming structure 3100 includes a bridge portion that divides an opening into two holes, each opening supplying air or a breathable gas to each of the patient's nostrils during use. The bridge portion may be configured to contact or seal the patient's trabeculae during use. Alternatively, the seal-forming structure 3100 may include a single opening that supplies airflow or air or a breathable gas to both of the patient's nostrils.

[0183] In some configurations, as described above, only the nasal mask may include a nasal pillow. 5.3.1.8 Mouth and nose mask

[0184] In one embodiment, the patient interface 3000 includes a seal-forming structure 3100 configured to seal around the entrance to the patient's nasal airway but not around the patient's mouth. The seal-forming structure 3100 may be configured to fit tightly to the jaw region of the patient's face. The patient interface 3000 can deliver air or breathable gas to both nostrils and the mouth of the patient 1000. This type of patient interface may be identified as an oro-nasal mask.

[0185] One form of the mouth-nose mask relating to this technology is what has conventionally been recognized as a "full-face mask" and has a seal-forming structure 3100 configured to seal the entire area around the nose, below the mouth, and above the nasal bridge on the patient's face. The mouth-nose mask may generally be triangular in shape. In one embodiment, the patient interface 3000 includes a seal-forming structure 3100 that, when in use, forms a seal between the patient's jaw area (which may include the patient's lower lip and / or the area directly below the lower lip), at least a portion of the nasal bridge or the nasal ridge above the anterior nostrils of the patient, and the cheek area of ​​the patient's face. The patient interface 3000 shown in Figure 1C is of this type. The patient interface 3000 can supply air or breathable gas to both nostrils and the mouth of the patient 1000 through a single orifice. This type of seal-forming structure 3100 may be called a "mouth-nose cushion".

[0186] In one embodiment, the patient interface 3000 includes a seal-forming structure 3100 that, when in use, forms a seal between the patient's jaw region (which may include the patient's lower lip and / or the region directly below the lower lip), the lower surface and / or front surface of the anterior portion of the patient's nose, the alae of the patient's nose, and each side of the patient's nose, for example, the part of the patient's face adjacent to the nasolabial fold. The seal-forming structure 3100 may also form a seal against the patient's upper lip. The patient interface 3000 having this type of seal-forming structure may have a single opening configured to deliver a gas flow or breathable gas to the patient's nostrils and oral cavity, or it may have an oral opening configured to deliver air or breathable gas to the oral cavity and nostrils configured to deliver air or breathable gas to the nostrils, or it may have an oral opening for delivering air to the patient's oral cavity and two nostrils for delivering air to the corresponding nostrils. The patient interface 3000 may have a nasal portion and an oral portion that are sealed to the patient's face in a similar position to a nasal cradle mask.

[0187] In a further form of the mouth-nasal mask, the patient interface 3000 may include a seal-forming structure 3100 having a nasal portion including a nasal pillow and an oral portion configured to form a seal to the patient's face around the patient's mouth.

[0188] In some embodiments, the seal-forming structure 3100 may have a nasal portion that is separate from and clearly distinguishable from the oral portion. In other embodiments, the seal-forming structure 3100 may form adjacent seals around the patient's nose and mouth.

[0189] It should be understood that the above embodiments of different forms of the patient interface 3000 do not constitute a detailed list of possible configurations. In some forms, the patient interface 3000 may include different combinations of features from the above-described examples of nasal-only and mouth-nasal mask only. 5.3.2 Plenum Chamber

[0190] The plenum chamber 3200 has a perimeter shape that complements the surface contour of an average human face in the area where a seal is formed during use. During use, the periphery of the plenum chamber 3200 is positioned close to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 can extend substantially around the entire circumference of the plenum chamber 3200 during use. In some embodiments, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous sheet of material.

[0191] In certain forms of this technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. In such forms, treatment compliance may be improved because it is less noticeable to the wearer and / or often increases wearer comfort.

[0192] In certain forms of this technology, the plenum chamber 3200 is constructed from a transparent material (e.g., transparent polycarbonate). The use of a transparent material can make the patient interface less conspicuous, which may help improve compliance with treatment. The use of a transparent material may also help clinicians confirm the position, shape, and function of the patient interface.

[0193] In a specific form of this technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the intrusiveness of the patient interface, thereby helping to improve compliance with treatment.

[0194] In some forms, the plenum chamber 3200 is made of a rigid material such as polycarbonate. The rigid material may support the seal-forming structure.

[0195] In some embodiments, the plenum chamber 3200 is constructed of a flexible material (e.g., made from a soft, flexible, and resilient material such as silicon, textile, or foam). For example, in some cases, they may be formed from a material having a Young's modulus of 0.4 GPa or less, such as foam. In some embodiments of the art, the plenum chamber 3200 may be formed from a material having a Young's modulus of 0.1 GPa or less, such as rubber. In other embodiments of the art, the plenum chamber 3200 may be formed from a material having a Young's modulus of 0.7 MPa or less, for example, 0.7 MPa to 0.3 MPa. One example of such a material is silicon. 5.3.2.1.1 Mouth and nose mask

[0196] As shown in Figure 7A, the plenum chamber 3200-1 includes a pair of plenum chamber inlet ports 3254-1, which may be used to transport gas to and from the plenum chamber 3200-1. The plenum chamber inlet ports 3254-1 may be located on opposite sides of the plenum chamber 3200-1 (e.g., left and right sides).

[0197] In some configurations, the plenum chamber 3200-1 may also include at least one ventilation opening 3402-1 (see, for example, Figure 7A). The ventilation opening 3402-1 may be located in the center of the plenum chamber 3200-1. For example, the ventilation opening 3402-1 may be located between the plenum chamber inlet ports 3254-1.

[0198] In some embodiments, the plenum chamber 3200-1 may include a pair of grooves 3266-1. Each groove 3266-1 may be located adjacent to one of the plenum chamber inlet ports 3254-1. Each groove 3266-1 may form a partially recessed surface. 5.3.2.1.2 Nasal Mask

[0199] The plenum chamber 3200-2 of the nasal cushion 3050-2 may be similar to the plenum chamber 3200-1 of the oral-nasal cushion 3050-1. Below, only some of the similarities and differences between the plenum chamber 3200-1 and the plenum chamber 3200-2 will be described.

[0200] As shown in Figure 4B, the plenum chamber 3200-2 includes a pair of plenum chamber inlet ports 3254-2, which may be used to transport gas to and from the plenum chamber 3200-2. The plenum chamber inlet ports 3254-2 may be located on opposite sides of the plenum chamber 3200-2 (e.g., left and right sides).

[0201] In some configurations, the plenum chamber 3200-2 may also include at least one ventilation opening 3402-2 (see, for example, Figure 7B). The ventilation opening 3402-2 may be located in the center of the plenum chamber 3200-2. For example, the ventilation opening 3402-2 may be located between the plenum chamber inlet ports 3254-2.

[0202] In some embodiments, the plenum chamber 3200-2 may include a pair of grooves 3266-2. Each groove 3266-2 may be located adjacent to one of the plenum chamber inlet ports 3254-2. Each groove 3266-2 may form a partially recessed surface. 5.3.3 Positioning and stabilization structure

[0203] The seal-forming structure 3100 of the patient interface 3000 of this technology may be held in the sealing position during use by a positioning and stabilization structure 3300. The positioning and stabilization structure 3300 may be configured and function as a "headgear" to engage with the patient's head in order to hold the patient interface 3000 in the sealing position. Examples of the positioning and stabilization structure are shown in Figures 3A and 3A-1.

[0204] In one embodiment, the positioning and stabilizing structure 3300 provides at least sufficient holding force to overcome the positive pressure effect of the plenum chamber 3200 (i.e., Fplenum) rising from the face.

[0205] In one configuration, the positioning and stabilizing structure 3300 provides sufficient holding force to overcome the attractive force on the patient interface 3000.

[0206] Continuing to refer to Figure 3A-1, the positioning and stabilizing structure 3300 provides a force FPSS that helps hold the plenum chamber 3200 in a sealing position on the patient's face. The positioning and stabilizing force FPSS may be the resultant force from various forces of various elements of the positioning and stabilizing structure 3300. For example, the headgear strap may individually supply a strap force Fstrap to press the seal-forming structure 3100 against the patient's face. The force Fstrap may be directed at least partially upward to counteract the attractive force Fg. The attractive force Fg may be specifically shown for the seal-forming structure 3100 and the plenum chamber 3200, but the attractive force should act on the entire patient interface 3000 (i.e., in the same direction as the illustrated attractive force Fg).

[0207] A frictional force Ff acts on the attractive force Fg, and this frictional force may act in the opposite direction to the attractive force Fg. As the attractive force pulls the seal-forming structure 3100 and the plenum chamber 3200 downward (as seen in Figure 3A-1), the frictional force Ff should act upward (for example, relative to the patient's face). For example, the patient may experience a frictional force Ff against their upper lip (and / or other surfaces of the patient's face in contact with the seal-forming structure 3100) to counteract the downward movement (this may help stabilize the cushion in place). Although the frictional force Ff is shown specifically to counteract the attractive force Fg of the seal-forming structure 3100 and the plenum chamber 3200, the overall frictional force component (not shown) should also counteract the attractive force Fg associated with the positioning and stabilizing structure 3300 and other parts of the patient interface 3000. Frictional forces may act along any point where the patient interface 3000 contacts the patient's skin (or hair). The frictional force Ff acts along the patient's skin (or hair) in the opposite direction to the attractive force Fg. In some forms, the attractive force Fg may also be offset by the vertical component of the reaction force from the patient's face acting on the seal-forming structure 3100, for example, at the bridge of the nose and chin of the patient's face.

[0208] In some configurations, the resultant force of various forces may be zero, causing the patient interface 3000 to reach a state of equilibrium (e.g., not moving along the patient's face during use). Specifically, the attractive force Fg and the outward force Fplenum attempt to move the seal-forming structure 3100 away from its predetermined sealing position. The positioning and stabilizing force FPSS is applied to counteract the attractive force Fg and the outward force Fplenum (and any frictional forces Ff) and to hold the seal-forming structure 3100 in the correct position. The positioning and stabilizing force FPSS may exceed the resultant force of the attractive force Fg and the outward force Fplenum (the additional positioning and stabilizing force FPSS is counteracted by the reaction force from the patient's head acting on the portion of the patient interface 3000), and the seal-forming structure 3100 may still be able to be held in the correct sealing position, but patient comfort may be compromised. 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, the comfort felt by the patient may be maximized. In some embodiments, the positioning and stabilization structure 3300 may be adjustable so that, when fitted, the positioning and stabilization force FPSS is greater than the force required to precisely balance the attractive force Fg and the blowing force Fplenum, and so that the seal is securely fixed to the patient interface 3000 on the patient's head so that the seal is not broken by destructive forces that may occur during use (such as the dragging of the tube when lying on one's side, or the lateral movement of the plenum chamber 3200). As described below, various positions of the patient's head while using the patient interface 3000 can determine the positioning and stabilization FPSS required to achieve equilibrium.

[0209] In one embodiment, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive forces affecting the patient interface 3000 (for example, those resulting from tube dragging or accidental interference with the patient interface).

[0210] In one embodiment of this technology, a positioning and stabilization structure 3300 is provided, configured to be worn by a patient while sleeping. In one embodiment, the positioning and stabilization structure 3300 has a thin profile or cross-sectional thickness to reduce the apparent or actual bulkiness of the device. In one embodiment, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilization structure 3300 includes at least one flat strap.

[0211] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a supine position with the posterior region of the patient's head resting on a pillow.

[0212] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a lateral position with the side of the patient's head resting on a pillow.

[0213] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a separation portion positioned between the front portion and the rear portion of the positioning and stabilizing structure 3300. This separation portion is not compressible and may be, for example, a flexible or pliable strap. The separation portion is constructed and positioned so as to prevent the seal from being disrupted when a patient lies down with their head on a pillow, due to the presence of the separation portion, by which force is transmitted along the positioning and stabilizing structure 3300 to the rear.

[0214] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam is porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the fabric outer layer includes a loop material that engages with a hook material portion.

[0215] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) strap. For example, the strap may be configured to be taut when in use, directing the force that seals the seal-forming structure into sealing contact with a portion of the patient's face. In one embodiment, the strap may be configured as a tie.

[0216] In one embodiment of this technology, the positioning and stabilizing structure includes a first tie, which is constructed and positioned such that, during use, at least a portion of its lower edge passes over the patient's head to the upper base of the ear and covers a portion of the parietal bone without covering the occipital bone.

[0217] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a second tie, which is constructed and positioned such that, in use, at least a portion of its upper edge passes below the lower earlobe on the underside of the patient's head and covers the occipital bone of the patient's head or rests on the underside of the occipital bone of the patient's head.

[0218] In one embodiment of this technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a third tie constructed and positioned to interconnect the first and second ties in order to reduce the tendency of the first and second ties to move away from each other.

[0219] In a particular embodiment of this technology, the positioning and stabilizing structure 3300 includes a flexible, and for example, non-rigid, strap. An advantage of this embodiment is that the strap is more comfortable when the patient lies down while sleeping.

[0220] In a particular embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap constructed to ensure breathability, allowing water vapor to pass through the strap.

[0221] In certain embodiments of this technology, a system is provided comprising two or more positioning and stabilizing structures 3300, each positioning and stabilizing structure 3300 configured to provide holding forces to accommodate different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for a large head rather than a small head, and another form that is suitable for a small head rather than a large head. 5.3.3.1 Conduit-type headgear 5.3.3.1.1 Conduit-type headgear tube

[0222] In some embodiments of this technology, the positioning and stabilization structure 3300 includes one or more headgear 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 a plenum chamber 3200 and a seal-forming structure 3100. In the embodiment of this technology shown in Figure 3Z, the positioning and stabilization structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the plenum chamber 3200. During use, the tubes 3350 position and stabilize the seal-forming structure 3100 of the patient interface 3000 in an appropriate part of the patient's face (e.g., nose and / or mouth). This makes it possible to connect the conduit of the air circuit 4170, which provides the flow of pressurized air, to a location other than the front of the patient's face, for example, to a connection port 3600 of the patient interface at the top of the patient's head.

[0223] In the embodiment of the technology shown in Figure 3Z, the positioning and stabilizing structure 3300 includes two tubes 3350, each positioned on a different side of the patient's head during use, extending across the entire cheek area, over each ear (above the earlobes on the patient's head), to the elbow 3610 at the top of the patient's head 1000. This embodiment of the technology may be advantageous because when the patient lies down with their head on their side, if one of the tubes 3350 is compressed to block or partially block the gas flow along the tube 3350, the other tube 3350 remains open, supplying pressurized gas to the patient. In other embodiments of the technology, the patient interface 3000 may include a different number of tubes, for example, one tube or three or more tubes.

[0224] In an embodiment where the patient interface has a single tube 3350, the single tube 3350 is positioned on one side of the patient's head (e.g., across the cheek area) during use, and a strap forms part of a positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head (e.g., across another area) during use to help secure the patient interface 3000 to the patient's head. For example, the tube 3350 and the strap may each be subjected to tension during use to help maintain the seal-forming structure 3100 in a sealing position.

[0225] In one embodiment, the tube 3350 may be at least partially stretchable so that the tube 3350 and the strap are adjusted to substantially equal lengths when worn by the patient. This may allow for substantially symmetrical adjustment between the tube 3350 and the strap, such that the seal-forming structure remains substantially central.

[0226] In the embodiment of the technology shown in Figure 3Z, two tubes 3350 are fluidly connected to each other at their upper ends and to a connecting port 3600. In some embodiments, the two tubes 3350 are integrally formed, and in other embodiments, the tubes 3350 are individually formed but connected in use and can be disconnected, for example, for cleaning or storage. When separate tubes are used, they may be indirectly connected integrally, for example, each connected to a T-connector. The T-connector has two arms / branchs, each of which is fluidly connectable to one of the tubes 3350. Furthermore, the T-connector may have a third arm or opening that provides a connecting port 3600 for fluidly connecting to an air circuit 4170 in use. The opening may be an inlet 3332 (see, for example, 7C) for receiving a flow of pressurized air.

[0227] In some configurations, the third arm of the T-connector may be substantially perpendicular to each of the first two arms.

[0228] In some configurations, the third arm of the T-shaped connector may be formed at an angle to each of the first two arms.

[0229] In some configurations, a Y-shaped connector may be used instead of a T-shaped connector. The first two arms may be angled relative to each other, and the third arm may be angled relative to the first two arms. The angled formation of the first two arms may resemble the shape of the patient's head in order to conform to the shape of the patient's head.

[0230] In some configurations, at least one of the arms of the T-shaped connector (or Y-shaped connector) may be flexible. This may allow the connector to be bent based on the shape of the patient's head and / or the forces in the positioning and stabilizing structure 3300.

[0231] In some forms, at least one of the arms of the T-shaped connector (or Y-shaped connector) may be at least partially cured. This can help maintain the shape of the connector so that the bend in the connector does not close the airflow path.

[0232] The tube 3350 can be formed from a flexible material, such as an elastomer such as silicon or TPE, and / or one or more fabrics and / or foamed materials. The tube 3350 may have a preformed shape and can be bent or moved into other shapes when a force is applied, but can return to its original preformed shape when no force is applied. The tube 3350 can have a generally arcuate or curved shape that approximates the contour of the patient's head between the crown and the nose or oral region.

[0233] In some embodiments, one or more tubes 3350 have crush resistance to prevent clogging when pushed in during use, such as when pushed between the patient's head and the pillow, particularly when there is only one tube 3350. The tube 3350 can be formed to have sufficient structural rigidity against crushing and can be configured as in U.S. Patent No. 6,044,844, the content of which is incorporated herein by reference.

[0234] Each tube 3350 may be configured to receive airflow from a connection port 3600 at the top of the patient's head and deliver airflow to a sealing structure 3100 at the entrance to the patient's airway. In the embodiment shown in Figure 3Z, each tube 3350, when in use, extends from the plenum chamber 3200 across the patient's cheek region and is positioned along a path from above the patient's ear to the elbow 3610. For example, the portion of each tube 3350 adjacent to the plenum chamber 3200 may cover the maxillary region of the patient's head during use. Other portions of each tube 3350 may cover the head region of the patient above the base of the ear at the top of the patient's head. Each of one or more tubes 3350 may also be positioned over the patient's sphenoid bone and / or temporal bone, as well as over one or both of the patient's frontal and parietal bones. The elbow 3610 may be positioned over the patient's parietal bone, frontal bone, or the junction between them (e.g., coronal suture) during use.

[0235] In certain embodiments of this technology, the patient interface 3000 is configured such that the connection ports 3600 are positioned at a series of locations across the top of the patient's head, thereby positioning the patient interface 3000 to suit the comfort or fit of an individual patient. In some embodiments, the headgear tube 3350 is configured such that the upper part of the patient interface 3000 (e.g., the connection ports 3600) can move relative to the lower part of the patient interface 3000 (e.g., the plenum chamber 3200). That is, the connection ports 3600 can be at least partially separated from the plenum chamber 3200. In this way, the seal-forming structure 3100 can form an effective seal with the patient's face regardless of the position of the connection ports 3600 on the patient's head (at least within a predetermined positional range).

[0236] As described above, in some embodiments of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle cushion that is typically positioned under the nose and sealed around the perimeter of the nose. A positioning and stabilization structure 3300, including a tube 3350, can be constructed and arranged to draw the seal-forming structure 3100 into the patient's face under the nose by a rearward and upward (e.g., posterior-upper) sealing force. Due to the posterior-upper sealing force, the seal-forming structure 3100 can form a good seal under the lower edge of the patient's nose and on the forward-facing surface of the patient's face, e.g., on either side of the patient's nose and on the patient's upper lip.

[0237] A conduit forming part of the positioning and stabilization structure 3300, such as a headgear strap, can provide a force that contributes to the positioning and stabilization force FPSS. As illustrated in FIG. 3Z-1, the positioning and stabilization force FPSS can be the resultant force from various forces of various elements of the positioning and stabilization structure 3300. For example, each conduit can supply a force Fconduit directed rearward and in respective lateral directions to hold the seal-forming structure 3100 against the patient's face (pushing it into the upper lip and sealing under the nose) and to counter the effect of the positive pressure (i.e., Fplenum) in the plenum chamber 3200 that would cause it to lift away from the face. The directed force can be at least partially upwardly directed to counteract the gravitational force Fg.

[0238] In some forms, the conduit can supply a force toward the patient's head when the conduit is filled with pressurized air. This force can assist in gripping the patient's head. This force can result from the conduit expanding during normal use. In some forms, this force can provide a cushioning effect on the patient's head. The conduit can be designed to limit expansion so as not to overly constrict the patient's head.

[0239] The gripping force of the conduits can also change depending on the position of the patient's head. For example, if the patient is lying on their side, the weight of the patient's head may compress one conduit, causing the other conduit (e.g., a lateral portion not located between the patient's head and the sleeping surface, such as a pillow) to expand further to maintain a substantially equal flow rate of pressurized air.

[0240] A frictional force Ff acts on the attractive force Fg, and this frictional force may act in the opposite direction to the attractive force Fg. As the attractive force pulls the seal-forming structure 3100 and the plenum chamber 3200 downward (as seen in Figure 3A-1), the frictional force Ff should act upward (for example, relative to the patient's face). For example, the patient may experience a frictional force Ff against their upper lip (and / or other surfaces of the patient's face in contact with the seal-forming structure 3100) to counteract the downward movement (this may help stabilize the cushion in place). Although the frictional force Ff is shown specifically to counteract the attractive force Fg of the seal-forming structure 3100 and the plenum chamber 3200, the overall frictional force component (not shown) should also counteract the attractive force Fg associated with the positioning and stabilizing structure 3300 and other parts of the patient interface 3000. Frictional forces may act along any point where the patient interface 3000 comes into contact with the patient's skin (or hair). The frictional force Ff acts along the patient's skin (or hair) in the opposite direction to the attractive force Fg.

[0241] In some configurations, the resultant force of various forces may be zero, causing the patient interface 3000 to reach a state of equilibrium (e.g., not moving along the patient's face during use). Specifically, the attractive force Fg and the outward force Fplenum attempt to move the seal-forming structure 3100 away from its predetermined sealing position. The positioning and stabilizing force FPSS is applied to counteract the attractive force Fg and the outward force Fplenum (and any frictional forces Ff) and to hold the seal-forming structure 3100 in the correct position. The positioning and stabilizing force FPSS may exceed the resultant force of the attractive force Fg and the outward force Fplenum (the additional positioning and stabilizing force FPSS is counteracted by the reaction force from the patient's head acting on the portion of the patient interface 3000), and the seal-forming structure 3100 may still be able to be held in the correct sealing position, but patient comfort may be compromised. 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, the comfort felt by the patient may be maximized. In some embodiments, the positioning and stabilization structure 3300 may be adjustable so that, when fitted, the positioning and stabilization force FPSS is greater than the force required to precisely balance the attractive force Fg and the blowing force Fplenum, and so that the seal is securely fixed to the patient interface 3000 on the patient's head so that the seal is not broken by destructive forces that may occur during use (such as the dragging of the tube when lying on one's side, or the lateral movement of the plenum chamber 3200). As described below, various positions of the patient's head while using the patient interface 3000 can determine the positioning and stabilization FPSS required to achieve equilibrium. 5.3.3.1.2 Extendable and non-extendable tube sections

[0242] In some embodiments of this technology, the length of one or two tubes 3350 is not extendable. However, in some embodiments, the tube 3350 may include one or more extendable tube portions formed, for example, by an extendable bellows structure. In some embodiments, the patient interface 3000 may include a positioning and stabilizing structure 3300 that includes at least one gas delivery tube having a tube wall having an extendable bellows structure. The patient interface 3000 shown in Figure 3Z includes a tube 3350 whose upper part has an extendable tube portion, and each tube portion is in the form of an extendable bellows structure 3362.

[0243] In some configurations, the expandable bellows structure 3328 may be formed as a series of ridges and grooves on the surface of the tube 3350. The bellows structure 3328 may be biased to a contracted position and may move to an expanded position when the patient wears the positioning and stabilizing structure 3300. Since a portion of the tube 3350 may be substantially immobile (e.g., an immobile tube portion 3363), the bellows structure 3328 allows the positioning and stabilizing structure 3300 to stretch to accommodate various head sizes. This may make it possible to use a single-size tube 3350 for multiple head sizes. For example, the positioning and stabilizing structure 3300 may be "universal" due to the bellows structure 3328. Alternatively, the tube 3350 may be manufactured in multiple sizes (e.g., small, medium, large). The patient may choose the length that best fits their head, and the bellows structure 3328 may be made to make small adjustments to fit individual patients.

[0244] In some configurations, the inlet 3332 may be located in the center of the conduit 6320. For example, the tube 3350 may be symmetrical with respect to the inlet 3332 via at least one axis.

[0245] The cross-sectional shape of the non-stretchable segment 3363 of tube 3350 may be circular, elliptical, oblong, D-shaped, or a rounded rectangle, for example, as described in U.S. Patent No. 6,044,844. A cross-sectional shape that presents a flat surface on the side of the tube that is in contact with the patient's face or other part of the head may be proportionally more comfortable to wear, as a tube with a circular cross-section.

[0246] In some embodiments of this technology, a non-extendable tube segment 3363 is connected to the plenum chamber 3200 at a low angle. The headgear tube 3350 may extend downward along both sides of the patient's head and then curve forward and in the middle to connect to the plenum chamber 3200 in front of the patient's face. The tube 3350 may extend to the same (or, in some embodiments, lower) vertical position as the connection to the plenum chamber 3200 before connecting to it. That is, the tube 3350 may project at least partially upward before connecting to the plenum chamber 3200. A portion of the tube 3350 may be located below the plenum chamber 3200 and / or the seal-forming structure 3100. The tube 3350 may contact the patient's face below the patient's cheekbones, which is more comfortable than contacting above the patient's cheekbones and can avoid excessive blurring of the patient's peripheral vision. 5.3.3.1.3 Conduit-type headgear connection port

[0247] In certain embodiments of this technology, the patient interface 3000 may include a connection port 3600 located near the top, side, or rear of the patient's head. For example, in the embodiment of this technology shown in Figure 3Z, the connection port 3600 is located at the top of the patient's head (e.g., higher relative to the patient's head). In this embodiment, the patient interface 3000 includes an elbow 3610 that forms the connection port 3600. The elbow 3610 may be configured to fluidly connect to a conduit of the air circuit 4170. The elbow 3610 may be configured to pivot relative to the positioning and stabilizing structure 3300 in order to at least partially isolate the conduit from the positioning and stabilizing structure 3300. In some embodiments, the elbow 3610 may be configured to rotate by rotating around a substantially vertical axis, and in some specific embodiments, it may be configured to rotate by rotating around two or more axes. In some embodiments, the elbow may include a tube 3350 or be connected to the tube 3350 via a ball joint. The connection port 3600 may be located in the sagittal plane of the patient's head during use.

[0248] A patient interface in which the connection port is not positioned in front of the patient's face may be advantageous because some patients may find the connection of the conduit to the patient interface in front of their face to be visually distracting and / or intrusive. For example, a conduit connecting to the patient interface in front of the face may be prone to entanglement in bedding or bed linens (especially if the conduit extends downward from the patient interface during use). Embodiments of this technology include a patient interface having a connection port positioned above the patient's head during use, enabling the patient to sleep more easily or comfortably in one or more positions, such as lateral, supine (e.g., supine, substantially upward), or prone (e.g., prone, substantially downward). Furthermore, if the conduit is connected in front of the patient interface, the conduit may exert undesirable force on the patient interface during movement of the patient's head or the conduit, thereby exacerbating a problem known as tube drag, which can cause the conduit to detach from the face. Tube resistance may not be a problem if the force is applied at a position above the patient's head rather than in front of the patient's face, which is closer to the seal formation structure (tube resistance is more likely to break the seal). 5.3.3.1.4 Fluid connection of the headgear tube

[0249] Two tubes 3350 are fluidly connected to a plenum chamber 3200 at their lower ends. In certain embodiments of the art, the connection between the tubes 3350 and the plenum chamber 3200 is achieved by the connection of two rigid connectors. The tubes 3350 and the plenum chamber 3200 may be configured to allow a patient to easily and reliably connect the two components. The tubes 3350 and the plenum chamber 3200 may be configured to provide tactile and / or auditory feedback in the form of a “reassurance click” or similar sound, so that the patient can easily know that each tube 3350 is properly connected to the plenum chamber 3200. In one embodiment, the tubes 3350 are formed of silicone, and the lower end of each silicone tube 3350 is overmolded onto a rigid connector, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector on each tube 3350 may include a male mating shape configured to connect to a female mating shape on the plenum chamber 3200. Alternatively, the rigid connector on each tube 3350 may include a female mating portion configured to connect to a male mating portion on the plenum chamber 3200. In other embodiments, each tube 3350 may include a male or female connector formed from a flexible material such as silicon or TPE, the same material that forms the tube 3350.

[0250] In other embodiments, compression seals are used to connect each tube 3350 to the plenum chamber 3200. For example, an elastically flexible (e.g., silicone) tube 3350 without a rigid connector may be configured to be compressed to reduce its diameter so that it can be compressed into a port in the plenum chamber 3200, with the inherent elasticity of silicone pushing the tube 3350 outward to hermetically seal it to the port. Alternatively, in a hard-to-hard type engagement between the tube 3350 and the plenum chamber 3200, each tube 3350 and / or the plenum chamber 3200 may include a pressure-operated seal, such as a periphery sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange can press the joint between the tubes against the outer circumferential surface around the port or connector of the plenum chamber 3200 to form or reinforce a seal between the tube 3350 and the plenum chamber 3200. 5.3.3.2 Headgear Straps

[0251] In some forms, the positioning and stabilizing structure 3300 may include a headgear 3302 that can be worn by a patient 1000, which includes at least one strap to help properly orient the seal-forming structure 3100 toward the patient's face (for example, to limit or prevent leakage).

[0252] As described above, several forms of the headgear 3302 may be composed of a woven material that can be comfortable against the patient's skin. The fibers may be flexible to conform to various facial contours. However, the fabric may include rigidity along a selected length, which can limit the bending, flexing, and / or stretching of the headgear 3302.

[0253] In certain embodiments, the headgear 3302 may be at least partially extensible. For example, the headgear 3302 may include elastic or similar stretchable materials. For example, the entire headgear 3302 may be stretchable, or selected portions may be stretchable (or more stretchable than surrounding portions). This may allow the headgear 3302 to stretch while under tension, making it easier to supply a sealing force to the seal-forming structure 3100.

[0254] Two forms of the headgear, namely, the four-point headgear 3302-1 and the two-point headgear 3302-2, will be described in detail below as examples. 5.3.3.2.1 Four-point connection

[0255] As shown in FIG. 7E, some forms of the headgear 3302-1 can be four-point connection headgears. This means that the headgear 3302-1 can be connected at four separate locations on the plenum chamber 3200, on a frame connected to the plenum chamber 3200, and / or on an arm connected to the plenum chamber 3200. The headgear 3302-1 may include four different straps that provide a tensile force to assist in maintaining the seal-forming structure 3100 in a sealing position. The positioning and stabilization structure 3300 of FIG. 3A can also be regarded as a four-point connection headgear.

[0256] In some embodiments, the headgear 3302-1 may include a lower strap 3304-1 that can be connected to the lower portion of the cushion 3050-1. The lower strap 3304-1 may extend along the patient's cheek towards the rear region of the patient's head. For example, the lower strap 3304-1 may overlap the masseter muscles on both sides of the patient's face. Thus, the lower strap 3304-1 can contact the patient's head under the patient's ear. The lower strap 3304-1 may converge at the rear of the patient's head and overlap the occipital bone and / or the trapezius muscle.

[0257] The headgear 3302-1 may also include an upper strap 3305-1 which may be positioned to cover the temporal bone, parietal bone, and / or occipital bone. The upper strap 3305-1 may also be connected to a tube 3350 (for example, by interface with a tab 3320).

[0258] The posterior strap 3307-1 may extend between the upper straps 3305-1 and between the lower straps 3304-1. The lower and upper straps 3304-1 and 3305-1 on a given side (e.g., left or right) may be adjacent to each other and connected to the posterior strap 3307-1. The height of the posterior strap 3307-1 may therefore be approximately the combined height of the lower straps 3304-1 and the upper straps 3305-1. The posterior strap 3307-1 may overlap the occipital and / or parietal bones when in use. This allows the posterior strap 3307-1 to assist in securing the headgear 3302-1 to the patient's head.

[0259] In the illustrated embodiment, the headgear 3302-1 may be formed substantially in an X shape. The lower and upper straps 3304-1, 3305-1 can be connected to the rear strap 3307-1 by sewing, ultrasonic welding, or a similar process.

[0260] In some configurations, the lower straps 3304-1 are connected to the magnetic members 3306-1. For example, each lower strap 3304-1 may be passed through the magnetic member 3306-1 so that the length of each lower strap 3304-1 can be adjusted. The magnetic member 3306-1 may be detachably connected to a magnet 3370-1 (described later), thereby allowing the lower straps 3304-1 to be disconnected from the plenum chamber 3200 without affecting the length of the lower straps 3304-1.

[0261] In some configurations, the upper straps 3305-1 may be directly connected to the tabs 3320 of the tube 3350. To adjust the length of each upper strap 3305-1 and control its tensile force, the upper straps 3305-1 may be passed through the tabs 3320.

[0262] In some configurations, the headgear 3302-1 can be used in conjunction with only the nose-mouth cushion 3050-1 (for example, because the nose-specific cushion 3050-1 does not have four connection points). However, the headgear 3302-1 can be used interchangeably with the tube 3350 and the rigid arm 3340. 5.3.3.2.2 Two-point connection

[0263] As shown in Figure 7F, some forms of the headgear 3302-2 may be a two-point connecting headgear. This means that the headgear 3302-2 can be connected to two separate locations.

[0264] In some forms, the headgear 3302-2 may be formed from a continuous material. In other words, the headgear 3302-2 may not be formed from multiple straps that are integrally connected (e.g., sutured). This may be more comfortable for the patient because it avoids contact with seams or joints connecting different straps. In other forms, the headgear 3302-2 may be formed from multiple straps that are integrally connected (e.g., two upper straps, a posterior strap, etc.) (e.g., sutured, ultrasonically welded, etc.).

[0265] In certain embodiments of the technology, the positioning and stabilizing structure 3300 includes at least one headgear strap acting in addition to the tube 3350 to position and stabilize the seal-forming structure 3100 at the entrance to the patient's airway. As shown in Figure 3Z, the patient interface 3000 includes a posterior strap 3307-2 that forms part of the positioning and stabilizing structure 3300. The posterior strap 3307-2 may be known, for example, as a back strap or posterior head strap. The posterior strap 3307-2 may overlap the temporal bone, parietal bone, and / or occipital bone. In other embodiments of the technology, one or more further straps may be provided. For example, the patient interface 3000 according to an embodiment of the technology having a nasal cushion may have a second lower strap configured to rest against the patient's head, which is close to the patient's neck, and / or against the posterior surface of the patient's neck.

[0266] In the embodiment shown in Figure 3Z, the straps 3310 of the positioning and stabilizing structure 3300 are positioned on each side of the patient's head and connected between two tubes 3350 that wrap around the back of the patient's head, for example, overlapping with or below the occipital bone of the patient's head during use. The straps 3310 are connected to each tube above the patient's ears. Referring to Figure 3Z, the positioning and stabilizing structure 3300 includes a pair of tabs 3320. During use, the straps 3310 can be connected between the tabs 3320. The straps 3310 have sufficient flexibility to bypass the back of the patient's head and comfortably rest against the patient's head, even when tension is applied during use.

[0267] As shown in Figure 7F, several forms of the headgear 3302-2 may be branched at least partially. For example, the rear strap 3307-2 of the headgear 3302-2 (e.g., configured to contact the back of the patient's head) may be wider than the periphery of the headgear 3302-2. The middle portion 3308-2 of the rear strap 3307-2 may include a slit 3309-2. Thus, the upper portion of the rear strap 3307-2 may be movable relative to the lower portion as a result of the slit 3309-2. This may allow the patient to have a wider strap coverage in the posterior region of their head, which may help to secure the headgear 3302-2 better to the patient's head because there is no lower strap (e.g., 3304-1).

[0268] In some configurations, the headgear 3302-2 may be used in conjunction with only the nose cushion 3050-2 (for example, because the nose and mouth cushion 3050-1 does not have four connection points). However, the headgear 3302-2 may be used in the same sense as the tube 3350 and the rigid arm 3340. 5.3.3.3 Rigid Arm

[0269] As shown in Figure 7D, the rigid arm 3340 may be an elongated rigid member that assists in maintaining the cushion (e.g., nose-mouth cushion 3050-1 or nose cushion 3050-2) in its working position. The rigid arm 3340 may contact the side of the patient's head and supply a force that limits the slippage of the seal-forming structure 3100 from the patient's nose and / or mouth.

[0270] In some forms, the rigid arm 3340 is made of a rigid material (e.g., plastic). The rigid material may not allow the rigid arm 3340 to stretch. Furthermore, the rigid arm 3340 may be substantially inflexible and impossible to bend. The rigid arm 3340 can be pre-molded into a desired shape to conform to the patient's head. For example, the rigid arm 3340 may be molded into a curved shape that substantially corresponds to the shape of the side of the patient's head (e.g., covering the masseter muscle and / or temporal bone).

[0271] In certain configurations, the rigid arm 3340 can be molded to fit the head of a particular patient (for example, the rigid arm 3340 is customized).

[0272] In some configurations, the rigid arm 3340 may be flexible along at least one direction. For example, the rigid arm 3340 may be flexible with respect to its width, but not along its length. In other words, the rigid arm 3340 may be bent about an axis along its width, but not about an axis perpendicular to it. This may allow individual patients to adjust the rigid arm 3340 to better suit their individual heads.

[0273] In certain configurations, the rigid arm 3340 can remain in its new position after being bent. This allows the patient to adjust the shape of the rigid arm 3340 to their specific head, and the rigid arm 3340 then maintains the desired shape during use to promote patient comfort.

[0274] In some configurations, the first end 3342 of the rigid arm 3340 may be a free end, and the second end 3344 of the rigid arm 3340 (e.g., opposite the first end 3342) may be fixed. The first end 3342 may be curved to minimize any sharp edges that could cause discomfort to the patient. The first end 3342 may also cover the patient's head in close proximity to the temporal bone during use. The second end 3344 may be fixed to an arm connection structure 3504.

[0275] In some forms, the arm connection structure 3504 may be similar to 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 may allow either the conduit connection structure 3500 or the arm connection structure 3504 to be fitted into a groove (e.g., 3266-1 or 3266-2) and connected to the plenum chamber inlet port 3254. The arm connection structure 3504 may be connected to the mouth-nasal cushion 3050-1 or the nose-only cushion 3050-2 in substantially the same manner as the conduit connection structure 3500 (e.g., by snap-fit, press-fit, friction fit, etc.).

[0276] In some embodiments, the arm connection structure 3504 may function as a plug for the plenum chamber inlet port 3254 (e.g., either 3254-1 and / or 3254-2). Unlike the tube 3350, the rigid arm 3340 does not transport pressurized air to the plenum chamber 3200. The rigid arm 3340 may be used in a “tube-down” configuration in which a hose is connected to a ventilation opening 3402 (e.g., either 3402-1 and / or 3402-2) to transport air through the ventilation opening 3402 to the plenum chamber 3200. In this embodiment, air does not need to enter or exit the plenum chamber inlet opening 3254. Thus, the arm connection structure 3504 may form a seal with the plenum chamber inlet opening 3254 to restrict airflow between it and the plenum chamber 3200. 5.3.4 Ventilation

[0277] In one embodiment, the patient interface 3000 includes a ventilation unit 3400 constructed and positioned to allow the washout of exhaled gases, such as carbon dioxide.

[0278] In a particular configuration, the ventilator 3400 is configured to allow a continuous ventilator flow from inside the plenum chamber 3200 to the environment, while simultaneously maintaining a positive pressure within the plenum chamber relative to the surroundings. The ventilator 3400 is configured to have a ventilator flow rate large enough to reduce rebreathing of CO2 exhaled by the patient while maintaining therapeutic pressure within the plenum chamber during use.

[0279] One embodiment of the ventilation unit 3400 relating to this 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).

[0280] The ventilation unit 3400 may be located in the plenum chamber 3200. Alternatively, the ventilation unit 3400 may be located within a separate structure such as a swivel unit.

[0281] As shown in Figure 7N, the ventilation unit 3450 may be used in conjunction with the patient interface 3000. The ventilation unit 3450 may have a shape substantially similar to that of the ventilation opening 3402-1 (for example, substantially circular).

[0282] The ventilation unit 3450 can be used in combination with either the oral-nasal plenum chamber 3200-1 (for example, shown in Figure 7A) or the nasal-only plenum chamber 3200-2 (for example, shown in Figure 7B).

[0283] Continuing to refer to Figure 7A, the ventilation unit 3450 may include a ventilation unit housing 3404, which may be configured to engage with the ventilation opening 3402. The ventilation unit housing 3404 may be made of a rigid or semi-rigid material. For example, the ventilation unit housing 3404 may be made of plastic, metal, or a similar material. The ventilation unit housing 3404 may add rigidity to the patient interface 3000 (for example, to limit unwanted bending that may affect the position of the seal-forming structure 3100 on the patient's face).

[0284] The ventilation housing 3404 may include a front surface 3408, a rear surface 3412, and a groove 3416. The front surface 3408 may face away from the patient's face during use and be located outside the pressurized volume of the plenum chamber 3200. The rear surface 3412 is located opposite the front surface 3408. During use, the rear surface 3412 may face the patient and be located within the pressurized volume of the plenum chamber 3200. The groove or side wall 3416 may be formed between the front surface and the rear surfaces 3408, 3412. To hold the ventilation unit 3400 in place, a portion of the plenum chamber 3200 may be received within the groove / side wall 3416.

[0285] In some configurations, the diffuser 3448 may be used in conjunction with the ventilation housing 3404. The diffuser 3448 may help limit the decibel output from any of the patient interfaces 3000 (or any other patient interfaces). Specifically, the diffuser 3448 may help limit the decibel level associated with the air output from the patient interface 3000 (e.g., exhalation), but the diffuser 3448 may limit the decibel level at any point in the patient interface.

[0286] In certain configurations, the diffuser 3448 can diffuse and, consequently, delay the exhaust gases exiting the plenum chamber 3200 and passing through the ventilation housing 3404. 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.).

[0287] In some forms, the diffuser may include a central component 3456 having an outer surface facing away from the patient during use. The outer diameter of the central component 3456 may be smaller than the inner diameter of the ventilation housing 3404 adjacent to the front surface 3408. This may create a gap 3464 through which air can pass.

[0288] 5.3.5 Separation structure (multiple structures possible) In one embodiment, the patient interface 3000 includes at least one separation structure to allow at least a portion of the patient interface to move relative to other portions of the patient interface. For example, the separation structure may be configured to separate a connection port from a seal-forming structure. In some embodiments, the separation structure may be a swivel or a ball joint. 5.3.6 Connection Ports

[0289] Connection port 3600 allows connection to the air circuit 4170. 5.3.7 Forehead support

[0290] In one embodiment, the patient interface 3000 includes a forehead support portion 3700. 5.3.8 Suffocation prevention valve

[0291] In one configuration, the patient interface 3000 includes an asphyxiation prevention valve. 5.3.9 Ports

[0292] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In another embodiment, this allows for direct measurement of the properties of the gas (e.g., pressure) within the plenum chamber 3200. 5.3.10 Modularity

[0293] As described above, cushions, headgear, and sleeves may be provided in various forms and may accommodate various applications (mouth breathing, nasal breathing, etc.). Patients or clinicians may select specific combinations of cushions, headgear, and sleeves to optimize the effectiveness of the therapy and / or the comfort of the individual patient. An example of this type of modular design is described in PCT / SG2022 / 050777, filed on 28 October 2022, which is incorporated herein by reference in its entirety.

[0294] In some forms, various types of cushions, headgears, and sleeves may be used interchangeably to form various combinations of patient interfaces. This may be beneficial from a manufacturing standpoint, as it allows for the creation of more diverse patient interfaces using fewer components. Additionally or alternatively, the various combinations may allow the patient to change the type of patient interface without changing all components. This modular design is described in more detail below and in Singapore Patent Application No. 10202112048R, the entirety of which is incorporated herein by reference.

[0295] Air is delivered to the patient in one of two main ways. In one embodiment, the patient may receive a flow of pressurized air through a headgear tube 3350 (see, for example, Figure 3Z). This may be referred to as a “tube-up” configuration, and the connection port may be located at the top of the patient’s head. In another embodiment, the patient may receive a flow of pressurized air through a conduit connected to a plenum chamber 3200, for example, through a connection port 3600 (see, for example, Figure 3A). This may be referred to as a “tube-down” configuration, where the airflow conduit is located in front of the patient’s face. For various patients, one mode of air delivery may be more comfortable than the other (for example, depending on the patient’s sleeping style). Therefore, it may be beneficial to allow the use of a single patient interface mode in either the “tube-up” or “tube-down” configuration.

[0296] A patient interface may be part of a modular assembly comprising various interchangeable components that allow the patient and / or clinician to swap one or more components of different types. The following description describes the various combinations that can be created by assembling different components together. 5.3.10.1 Sleeves

[0297] In some configurations, the sleeve may be used in conjunction with the tube 3350 and / or rigid arm 3340 to enable modularization. The sleeve may at least partially surround the tube 3350 and / or rigid arm 3340. Different shaped sleeves may be used, as shown in Figures 7G to 7I, which may correspond to different types of positioning and stabilization structures 3300. In some configurations, the sleeve configuration may be customized to suit the face of a particular user. For example, the sleeve may be configured in a relatively posterior region of the patient's head.

[0298] In some forms, the sleeve may be made of a comfortable material. For example, the sleeve may be made of a fibrous material, a foamed material, or a combination of both. The comfortable material may come into contact with the patient during use and may provide a soft feel to the patient's skin to improve patient compliance.

[0299] The material may also be flexible to assist in attaching and detaching the sleeve from the tube 3350 or the rigid arm 3340. For example, the material may allow the sleeve to be bent to conform to the shape of the tube 3350 or the conduit headgear or rigid arm 3340, which may vary depending on the shape of the individual patient's head.

[0300] In some forms, the sleeve may also be at least partially elastic (for example, the material may allow the sleeve to stretch). The elastic material may help the sleeve stretch to fit around the tube 3350 or the rigid arm 3340. The elastic material may then return to its initial tight-fitting position against the tube 3350 or the rigid arm 3340 to limit the sleeve from slipping during use.

[0301] As will be described in more detail below, some forms of sleeves may be specific to the rigid element (e.g., tube 3350 and / or rigid arm 3340). However, sleeves may be useful for connecting the rigid element to the corresponding version or style of cushion (e.g., mouth-nose cushion 3050-1, nose-only cushion 3050-2, etc.) in a compatible manner. 5.3.10.1.1 Conduit sleeve

[0302] As shown in Figure 7G, one embodiment of the sleeve is a conduit sleeve 3351 that can be used in combination with the tube 3350 described above.

[0303] As shown in Figure 7G, the conduit sleeve 3351 may include a curved shape that may resemble the shape of the tube 3350 shown in Figure 7C. The flexible material used to construct the conduit sleeve 3351 may allow the conduit sleeve 3351 to bend further to conform to the shape of the tube 3350 (for example, when fitted by a patient).

[0304] In some embodiments, the conduit sleeve 3351 may include a first or upper opening 3352. The upper opening 3352 may be located at one end of the conduit sleeve 3351. The upper opening 3352 may be an opening to a passage extending along at least a portion of the conduit sleeve 3351.

[0305] As shown in Figure 7G, some forms of the conduit sleeve 3351 may also include a lower extension 3354. The lower extension 3354 may be positioned at the opposite end from the upper opening 3352 of the conduit sleeve 3351. The conduit sleeve 3351 may be customized to fit the face of a particular user. For example, the lower extension 3354 of the conduit sleeve 3351 may be configured in a relatively posterior or anterior region of the patient's head.

[0306] Some forms of the lower extension 3354 may include a rigid or semi-rigid piece (for example, within the conduit sleeve 3351). The rigid or semi-rigid piece may be made of a plastic material or a similar material. Alternatively, the lower extension 3354 may be made rigid using a manufacturing process (e.g., stiff thread stitching, plain knitting, use of thicker material).

[0307] As shown in Figure 7G, some forms of the lower extension 3354 may include a connecting member 3356. In the illustrated embodiment, the connecting member 3356 may be a magnet, but in other embodiments, the connecting member 3356 may be a different type of connector (e.g., a mechanical fastener, adhesive, hook and loop material, etc.). The connecting member 3356 may also be located at the end of the lower extension 3354, but alternatively, the connecting member 3356 may be positioned anywhere along the lower extension 3354.

[0308] In some configurations, the connecting member 3356 (e.g., a magnet) may be detachably 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, for example, Figure 7J), the magnet 3370-1 connected to the lower strap 3304-1 may be detachably connected to the connecting member 3356 in order to provide tensile force. 5.3.10.1.2 4-point arm sleeve

[0309] As shown in Figure 7H, another embodiment of the sleeve is a four-point arm sleeve 3380 which can be used in conjunction with the rigid arm 3340 described above.

[0310] As shown in Figure 7H, the four-point arm sleeve 3380 may include a curved shape that may resemble the shape of the rigid arm 3340 shown in Figure 7D. The flexible material used to construct the four-point arm sleeve 3380 may allow the four-point arm sleeve 3380 to bend further to correspond to the shape of the rigid arm 3340 (for example, when fitted by a patient and / or bent by a patient).

[0311] As shown in Figure 7H, some forms of the four-point arm sleeve 3380 may include a lower extension 3384. The lower extension 3384 may be positioned at the end of the four-point arm sleeve 3380.

[0312] In the illustrated embodiment, the shape and / or structure of the lower extension 3384 is substantially the same as the shape of the lower extension 3354. For example, the lower extension 3384 may be more rigid (e.g., by hardened yarn or rigid material) than the rest of the four-point arm sleeve 3380.

[0313] As shown in Figure 7H, some forms of the lower extension 3384 may include a connecting member 3386. In the illustrated embodiment, the connecting member 3386 may be a magnet, but in other embodiments, the connecting member 3386 may be a different type of connector (e.g., a mechanical fastener, adhesive, hook and loop material, etc.). The connecting member 3386 may also be positioned at the end of the lower extension 3384, but alternatively, the connecting member 3386 may be positioned anywhere along the lower extension 3384.

[0314] In some configurations, the connecting member 3386 (e.g., a magnet) may be detachably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the four-point arm sleeve 3380 is connected to the rigid arm 3340 (see, for example, Figure 7K), the magnet 3370-1 connected to the lower strap 3304-1 may be detachably connected to the connecting member 3386 in order to provide tensile force.

[0315] As shown in Figure 7H, 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 the four-point arm sleeve 3380 is fitted by the patient, the tabs 3394 may be positioned on the patient's head at substantially the same location where the tabs 3320 are positioned when the patient fits the tube 3350. 5.3.10.1.3 Two-point arm sleeve

[0316] As shown in Figure 7I, yet another embodiment of the sleeve is a two-point arm sleeve 3380-1, which can be used in conjunction with the rigid arm 3340 described above.

[0317] In some configurations, the two-point arm sleeve 3380-1 may be similar to the four-point arm sleeve 3380 described above. Below, only some of the similarities and differences will be explained.

[0318] As shown in Figure 7I, the two-point arm sleeve 3380-1 may include a lower opening 3388-1 positioned at the end of the two-point arm sleeve 3380-1. The lower opening 3388-1 may form an opening to a passage that penetrates the two-point arm sleeve 3380-1. In the illustrated embodiment, the lower opening 3388-1 may open to the surface of the conduit sleeve 3380-1.

[0319] As shown in Figure 7I, 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 the two-point arm sleeve 3380-1 is fitted by the patient, the tabs 3394-1 may be positioned on the patient's head at substantially the same location where the tab 3320 is positioned when the patient fits the tube 3350. 5.3.10.2 Patient Interface After Assembly

[0320] As shown in Figures 7J to 7M, the various elements described above may be combined into four different patient interfaces. The various patient interfaces may allow patients to use different styles based on their individual comfort. The modularity of the various elements (e.g., usability in multiple styles of patient interfaces) may allow for simplified manufacturing and / or allow patients to switch between styles of patient interfaces more easily. 5.3.10.2.1 Oral and Nasal Mask Tube Up Configuration

[0321] As shown in Figure 7J, the patient may wear the cushion 3050-1 in a tube-up configuration with the tube 3350 and the four-point headgear 3302-1. This assembly can form a tube-up nasopharyngeal patient interface 3000-1.

[0322] In some configurations, a conduit sleeve may be used with tube 3350 to allow the patient to utilize a “tube-up” air supply mode with the oral-nasal cushion 3050-1. As described later, the conduit sleeve provides an additional connection point for connecting the four-point headgear 3302-1. However, other forms of connectors may be used in addition to or in addition to the conduit sleeve.

[0323] In the illustrated embodiment, the conduit sleeve may be connected to the tube 3350 of the positioning and stabilizing structure 3300. The tube 3350 may be used to connect the tube 3350 to the cushion 3050-1 (via the conduit connection structure 3500). The conduit sleeve provides a magnet for connection to the magnet 3370-1 of the four-point headgear 3302-1 (see, for example, Figure 7E). Alternatively, another connection configuration may be used.

[0324] As shown in Figure 7K, the four-point headgear 3302-1 can be connected at four separate points to provide tensile force to maintain the cushion 3050-1 in a sealed position on the patient's head.

[0325] For example, the lower strap 3304-1 may be detachably connected to the magnet of the conduit sleeve (e.g., via the magnetic member 3306-1). When in use, each lower strap 3304-1 may come into contact with the patient's cheek (e.g., overlapping the masseter muscle). The lower strap 3304-1 may also extend below the patient's ear. 5.3.10.2.2 Oral-nasal mask tube-down configuration

[0326] As shown in Figure 7K, the patient may wear the cushion 3050-1 in a tube-down configuration with a rigid arm 3340 and a four-point headgear 3302-1. This assembly may form a tube-down nasopharyngeal patient interface 3000-2.

[0327] In some configurations, a conduit sleeve may be used in conjunction with the rigid arm 3340 to allow the patient to utilize a “tube-down” air supply mode with the oral-nasal cushion 3050-1. As described later, the conduit sleeve provides an additional connection point for connecting the four-point headgear 3302-1. However, other forms of connectors may be used in addition to or instead of the conduit sleeve.

[0328] In the illustrated embodiment, the conduit sleeve may be connected to a rigid arm 3340 of the positioning and stabilizing structure 3300. The rigid arm 3340 may be used to connect the rigid arm 3340 to the cushion 3050-1 (via the conduit connection structure 3504). The conduit sleeve provides a magnet for connection to the magnet 3370-1 of the four-point headgear 3302-1 (see, for example, Figure 7E). Alternatively, another connection configuration may be used.

[0329] As shown in Figure 7K, the four-point headgear 3302-1 can be connected at four separate points to provide tensile force to maintain the cushion 3050-1 in a sealed position on the patient's head.

[0330] For example, the lower strap 3304-1 may be detachably connected to the magnet of the conduit sleeve (e.g., via the magnetic member 3306-1). When in use, each lower strap 3304-1 may come into contact with the patient's cheek (e.g., overlapping the masseter muscle). The lower strap 3304-1 may also extend below the patient's ear. 5.3.10.2.3 Nasal Mask Tube Up Configuration

[0331] As shown in Figure 7L, the patient may wear the cushion 3050-2 in a tube-up configuration with the tube 3350 and the two-point headgear 3302-2. This assembly may form a dedicated patient interface 3000-3 for the tube-up nose.

[0332] The conduit sleeve may be used in conjunction with the tube 3350 to provide further comfort to the patient. The sleeve may not add any additional connection points for connecting the positioning and stabilization structure 3300 on the cushion 3050-2. In the illustrated embodiment, the tube 3350 of the positioning and stabilization structure 3300 may be directly connected to the cushion 3050-2.

[0333] As shown in Figure 7L, the two-point headgear 3302-2 may be connected to a tab 3320 on the tube 3350 to provide tensile force to maintain the cushion 3050-2 in a sealed position on the patient's head. 5.3.10.2.4 Nasal Mask Tube Down Configuration

[0334] As shown in Figure 7M, the patient may wear the cushion 3050-2 in a tube-up configuration with a rigid arm 3340 and a two-point headgear 3302-2. This assembly may form a tube-down nasal-specific patient interface 3000-4.

[0335] The conduit sleeve may be used in conjunction with the rigid arm 3340 to provide further comfort to the patient. The sleeve may not add any additional connection points for connecting the positioning and stabilization structure 3300 on the cushion 3050-2. In the illustrated embodiment, the rigid arm 3340 of the positioning and stabilization structure 3300 may be directly connected to the cushion 3050-2.

[0336] As shown in Figure 7M, the two-point headgear 3302-2 may be connected to a tab 3320 on the sleeve to provide tensile force to maintain the cushion 3050-2 in a sealed position on the patient's head. 5.3.10.2.5 Modularity of Elements

[0337] Figure 7P shows how different elements can be combined to form the four different patient interfaces described above. As illustrated, various components can be reused in various types of patient interfaces. This can facilitate manufacturing and assembly by producing a large number of identical components that can be reused in various types. The only component that may not be used in multiple types is the sleeve. However, sleeves can be manufactured more easily. Figure 7O shows a portion of the air circuit 4170 that can interface with the patient interface, and Figure 7N shows a ventilation unit 3404 that can interchangeably replace the air circuit shown in Figure 7O depending on the type of patient interface. 5.4 RPT Devices

[0338] An RPT device 4000 according to one aspect of this technology includes mechanical, pneumatic, and / or electrical components and is configured to perform one or more algorithms 4300 (e.g., any of the methods described herein, either whole or in part). The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway and may be configured, for example, to treat one or more respiratory conditions described elsewhere herein.

[0339] In one embodiment, the RPT device 4000 is constructed and positioned to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH2O, at least 10 cmH2O, or at least 20 cmH2O. 5.5 Air Circuit

[0340] An air circuit 4170 according to one aspect of this technology is a conduit or tube (referred to herein as an air tube) constructed and positioned so that, when in use, the airflow can move between two components of a respiratory therapy system (e.g., an RPT device 4000 and a patient interface 3000 or 3800).

[0341] Specifically, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface, for example, by connecting to the connection port 3600 of the patient interface. In some embodiments, the air circuit may include a cuff or connector to assist in connecting the air circuit to the RPT device 4000 or flow generator and the patient interface. For example, the first end of the conduit / air tube may include a connector or cuff configured to assist in connecting the air circuit to the flow generator, and the second end of the conduit / air tube may include a connector or cuff configured to assist in connecting the air circuit to the flow generator.

[0342] In some embodiments, the air circuit may include a separation structure, such as a swivel or ball joint, that allows a portion of the air circuit to swivel or rotate relative to another portion of the air circuit.

[0343] The air circuit may be called an air delivery tube. In some cases, there may be separate limbs for inhalation and exhalation. In other cases, a single limb is used.

[0344] In some embodiments, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (for example, to maintain or raise the air temperature). The heating elements may include a heating wire circuit and one or more transducers (e.g., temperature sensors). In one embodiment, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating elements are communicable to a processor for their control. One embodiment of the air circuit 4170 including the heating wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety. 5.6 Humidifier 5.6.1 Overview of Humidifiers

[0345] In one embodiment of this technology, a humidifier 5000 is provided (for example, as shown in Figure 5A) to alter the absolute humidity of the air or gas delivered to the patient relative to the surrounding air. Typically, the humidifier 5000 is used to increase the absolute humidity and raise the temperature of the airflow (compared to the ambient air) before delivery to the patient's airway.

[0346] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a flow of humidified air. In some embodiments, as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006 which may be adapted to house the humidifier reservoir 5110 and may include a heating element 5240. 5.7 Respiratory waveform

[0347] Figure 6A shows a typical respiratory waveform model of a human during sleep. The horizontal axis represents time, and the vertical axis represents respiratory flow rate. Although parameter values ​​can vary, typical respiration can approximate the following values: 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 respiratory time Ttot is approximately 4 seconds. Typically, a human breathes at a rate of approximately 15 breaths per minute (BPM), and ventilation vent is approximately 7.5 L / min. The ratio of the typical duty cycle, Ti to Ttot, is approximately 40%. 5.8 Forehead cooling

[0348] Patients with OSA are far more likely to suffer from comorbid insomnia than the average patient. Forehead cooling has been shown to shorten the time to fall asleep in patients with insomnia. Therefore, one aspect of this technology is to provide a forehead cooling system 2000 configured to lower the temperature of the patient's forehead when in use.

[0349] In some embodiments, the forehead cooling system 2000 may be incorporated into a treatment system for sleep-disordered breathing and / or insomnia. For example, the forehead cooling system may be incorporated into or configured to be attached to a patient interface 3000, a positioning and stabilization structure 3300 for the patient interface 3000, and / or an air circuit 4170 configured to supply a breathable gas flow to the patient interface 3000.

[0350] In some embodiments of the technology discussed herein, these forehead cooling systems can use, for example, an airflow from an RPT device 4000 or exhaled air from the patient's airway as a means of cooling the patient's forehead. For example, this airflow can be directed toward or across the surface of the patient's forehead to remove heat from the patient's forehead, for example by utilizing convection.

[0351] In an embodiment of this technology using the humidifier 5000, humidifying the airflow makes it possible to further promote a decrease in the temperature of the patient's forehead.

[0352] In another embodiment of this technology, a liquid-type forehead cooling system 2000 can be provided. Such a system is configured to facilitate heat transfer from the patient's forehead, for example, by utilizing conductive cooling.

[0353] In a further embodiment of this technology, the active forehead cooling system 2000 may be provided using, for example, a Peltier condenser.

[0354] In one embodiment of this technology, the system may include components such as active components including a heat exchanger, an evaporative cooler, or a Peltier cooler. Several embodiments of heat and / or humidity exchangers that may be used in conjunction with this technology are described in PCT Publication WO / 2013 / 067592, which is incorporated herein by reference in its entirety.

[0355] It should be understood that in the embodiments described herein, one or more of these techniques may be used alone or in combination to provide a forehead cooling function.

[0356] Although this technology is primarily described in relation to supporting the treatment of insomnia, it is believed that it may also be beneficial in supporting the treatment of other conditions such as dyspnea, menopausal symptoms, hypertension, anxiety, hyperthyroidism, anhidrosis, diabetes, migraines, and chronic pain. In other embodiments, this technology may provide advantages in terms of sleep comfort, such as during pregnancy and the luteal phase of the menstrual cycle. 5.8.1 Forehead cooling technology 5.8.1.1 Air Cooling

[0357] Referring to Figure 8A, the patient interface 3000 is provided with a forehead cooling system 2000. The forehead cooling system 2000 is connected to and supported by a positioning and stabilization structure 3300. For example, the forehead cooling system may include a first end 2002 connected to and supported by a first side 4171 of the positioning and stabilization structure 3300, and a second end 2004 connected to and supported by a second side 4172 of the positioning and stabilization structure 3300.

[0358] In the illustrated embodiment, the forehead cooling system 2000 is connected to a positioning and stabilization structure 3300 located above the patient's eyes to minimize the risk of obstructing the patient's field of vision. The forehead cooling system 2000 is positioned such that a gap 2006 is provided between the forehead cooling system 2000 and a connection port 3600 located on the top of the patient's head. This gap has the advantage of allowing the patient's hair to pass through, enhancing comfort and reducing irritation.

[0359] The forehead cooling system 2000 can be positioned and attached to a positioning and stabilizing structure using any suitable method, such as attachment to one or more straps, as described herein.

[0360] The forehead cooling system 2000 may be configured to be attached to the positioning and stabilization structure 3300, for example, by being detachably attached using one or more fasteners such as clips, buckles, or hook-and-loop fasteners. In some embodiments, the forehead cooling system 2000 may be detachably attached to one side of the positioning and stabilization structure 3300 and non-detachably attached to the other side. In other embodiments of the Art, the forehead cooling system may be non-detachably bonded to the positioning and stabilization structure 3300.

[0361] In some embodiments, the forehead cooling system 2000 is attached to the positioning and stabilizing structure 3300 by an adjustment mechanism such as a hook-and-loop fastener or buckle (not shown), allowing the patient to adjust the force applied to the patient's forehead during use. Furthermore, the forehead cooling system may include a flexible material (e.g., elastic or elastane material) to ensure that the forehead cooling system 2000 remains in contact with the patient's forehead in various sleeping positions.

[0362] In some embodiments, the forehead cooling system 2000 may be configured to be fluidly connected to a patient interface 3000 or an air circuit 4170. For example, airflow through the patient interface 3000 and / or the air circuit 4170 may be used to cool the patient's forehead when in use, as described herein. In the embodiment of Figure 8A, 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, so that airflow received through the connection port 3600 passes through the forehead cooling system 2000 or (for example, by utilizing the Venturi effect) generates airflow within the forehead cooling system 2000 to remove heat from the patient's forehead region.

[0363] For example, the forehead cooling system 2000 may be fluidly connected at a first end 2002 to a first side 4171 of the positioning and stabilizing structure 3000, such that the airflow from the connection port 3600 to the patient interface is fluidly coupled to the forehead cooling system 2000. The second end 2004 may be configured to draw in air from the ambient environment (e.g., using the Venturi effect). This can advantageously draw in cooler and / or drier air than that which may be provided by the RPT device 4000, especially if a heated / humidified air supply or air circuit 4170 is used. To prevent air from being ventilated from the second end 2004, a one-way valve may be used that allows air to be drawn in but does not allow ventilation. Examples of suitable valves will be well known to those skilled in the art.

[0364] For example, Figure 8B shows a cross-sectional view of the forehead cooling system 2000, which takes the form of a fluid conduit 8005 that can be fluidly coupled to the patient interface 3000 and / or the RPT device 4000. For example, as described herein, the positioning and stabilizing structure 3300 may include a conduit headgear that is supplied with a flow of pressurized breathable gas during use. For example, a flow of pressurized breathable gas generated by the RPT device 4000 may be delivered through the fluid conduit of the forehead cooling system 2000 to cool the patient's forehead during use.

[0365] In one embodiment, the fluid conduit 8005 may include a fibrous material or be composed entirely of a fibrous material. An embodiment of the fibrous conduit is described in detail in PCT Publication WO2012167327A1, published on December 13, 2012, which is incorporated herein by reference in its entirety.

[0366] The use of fibers may offer advantages such as improved patient comfort and, consequently, better compliance with respiratory therapy.

[0367] In some embodiments of this technology, the breathable gas flow passing through the forehead cooling system 2000 may be sufficient to cool the patient's forehead region, for example, by convective cooling. In some embodiments 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 silicon, such as carbon-impregnated silicon, or one or more metals, such as thin, flexible metal strands or layers.

[0368] In some embodiments of this technology, the fluid conduit 8005 may include a semipermeable material configured to release an airflow received from the connection port 3600 onto the patient's forehead to cool this forehead. For example, the fluid conduit 8005 material may be configured such that a portion of the breathable gas flow passes through the conduit and reaches the patient's forehead region. For example, the fluid conduit 8005 may be configured to allow an airflow to pass through. For example, the fluid conduit 8005 may include one or more holes 8007 configured to allow a breathable gas flow to pass through. The holes 8007 may allow for more precise control over what is being cooled and the cooling rate (for example, by controlling the number and size of the holes). For example, the fluid conduit 8005 may have 3 to 100 holes 8007 along its length, for example, about 10 to 50 holes 8007.

[0369] In other embodiments, the fluid conduit 8005 may be made of a breathable material that allows some airflow to pass through. For example, the fluid conduit 8005 may be made of a fabric, through which airflow may be provided in the gaps between the fibers or threads of the fabric, and / or through which some airflow may pass.

[0370] In other embodiments of this technology, the forehead cooling system 2000 may be configured to remove heat from the forehead by transferring heat from the forehead to an airflow while in contact with the patient's forehead, and then delivering the heated air to the patient's respiratory airway. As is well known to those skilled in the art, heating the breathable gas / airflow before the patient inhales can improve the comfort and compliance of the respiratory pressure therapy system.

[0371] In one embodiment shown in Figure 8C, 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 remove heat from the patient's forehead during use. For example, the patient contact layer 8009 may be composed of a thermally conductive material as described herein.

[0372] In some embodiments of the present technology described herein, the patient contact layer 8009 may be a thermoelectric cooler 5005.

[0373] The patient contact layer is fitted with a fluid conduit 8005 configured to receive a fluid flow, such as a flow of breathable gas. In some embodiments, this fluid flow may be a liquid such as water, and in other embodiments, a breathable gas such as air / oxygen. By advantageously utilizing this fluid flow, heat can be removed from the patient contact layer, thereby cooling the patient's forehead.

[0374] In some embodiments, the patient contact layer 8009 may form one of the walls of the fluid conduit 8005, and in other embodiments, such as those shown in Figure 8C, the patient contact layer 8009 may adhere to an interface layer 8011 between the patient contact layer 8009 and the fluid flow 'F' through the fluid conduit 8005. For example, it may be 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 embodiment, the interface layer 8011 functions as one of the walls of the fluid conduit 8005. The interface layer 8011 may further be more porous (i.e., having more pores, or pores of a larger diameter 8007) or have a higher thermal conductivity than other materials (such as fibrous materials) used in the fluid conduit 8005, and in some embodiments described herein, this interface layer 8011 may be a thermal interface material 6002, which is described in more detail in relation to Figure 12A.

[0375] In some embodiments of this technology, it may be beneficial to monitor and / or control the temperature of the forehead cooling system 2000 and / or the temperature of the patient's forehead. Therefore, in some embodiments of this technology, the forehead cooling system 2000 may include one or more sensors 8013, such as temperature, humidity, heart rate, or electroencephalogram (EEG) sensors. These sensors 8013 may be used to provide information regarding the effectiveness of the forehead cooling system 2000 or to provide feedback on whether forehead cooling is necessary. It should be understood that these sensors 8013 may be communicatively coupled to a processor, such as via a wired or wireless connection. For example, the processor may be provided in the RPT4000 or a personal computing device such as a smartphone or computer. Further embodiments of the monitoring system are described below. 5.8.1.2 Fluid cooling

[0376] As an embodiment of the technology shown in Figure 9, a forehead cooling system 2000 is provided, which includes a fluid transfer system 3001 configured to transfer heat from the patient's forehead 1000, for example, using thermal conduction. Although this system is shown schematicly for simplification, it should be understood that it may be mounted on the patient interface 3000, such as being attached to a positioning and stabilization structure 3300, or otherwise attached as described herein.

[0377] 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, when in use. The reservoir 3002 may include an inlet 3004 configured to receive the fluid flow and an outlet 3006 configured to transfer the fluid from the reservoir, for example, for cooling or recirculation via a pump 3008.

[0378] In some embodiments of this technology, pump 3008 may be a peristaltic pump or other suitable fluid pump, and for example, if the fluid is air, pump 3008 may be a blower. In some embodiments of this technology, the blower may be a blower housed within an RPT device 4000, configured to generate a flow of breathable air into the patient's airway for the treatment of sleep apnea syndrome.

[0379] In some embodiments of this technology, the reservoir 3002 may be flexible so as to conform to the patient's forehead, i.e., such as a flexible fluid bladder, such as a plastic bladder made from a flexible material such as polyvinyl chloride or thermoplastic urethane. In other embodiments, the reservoir may be configured to be thermally connected to the patient's forehead via a thermal interface material 6002, as will be discussed later in relation to Figure 12A.

[0380] In some embodiments 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 other suitable gels. 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 a fluid such as oil or water alone, or by increasing the heat capacity of the heat transfer medium (compared to oil or water alone).

[0381] In some embodiments of this technology, for example, in embodiments in which the forehead cooling system is removable, the reservoir 3002 may be cooled in a refrigerator before use to provide a rapid temperature drop to aid in falling asleep. Thus, one aspect of this technology is to provide a forehead cooling system 2000 that can be removed from the positioning and stabilizing structure 3300 and cooled before use to aid in falling asleep.

[0382] In some embodiments of this technology, the reservoir 3002 may contain a phase-change material (PCM), such as sodium acetate trihydrate. Upon use, this phase-change material changes to a liquid state upon heating and is activated during use by a bending process or by snapping a metal disc within the reservoir, converting the PCM from a liquid to a solid state, thereby providing a cooling effect. The PCM material can then be prepared for the next sleep session by heating the liquid and converting it back from solid to liquid. In embodiments of this technology using PCM material, the pump 3008 is not required, and the forehead cooling system 2000 may simply include a reservoir of PCM material held in a fixed position on the patient's forehead.

[0383] Figure 10 shows an embodiment in which the forehead cooling technology of Figure 9 engages with the forehead of patient 1000. In this embodiment, the reservoir 3002 is supported when engaged with the forehead of patient 1000 using a positioning and stabilization structure 3300. For example, the reservoir may be attached to one or more straps or conduits on either side of the patient's head.

[0384] Therefore, by combining the forehead cooling system 2000 with the patient interface, it may be possible to utilize the positioning and stabilizing structure 3300 used to position and stabilize the patient interface in an engaged state with the patient's face. Similarly, it may be possible to treat comorbid insomnia and sleep apnea syndrome simultaneously with a single system. 5.8.1.3 Thermoelectric cooling

[0385] Figure 11 shows one embodiment of the present technology in which a radiator 5000 is provided to transfer heat between the fluid in the forehead cooling system 2000 and the surrounding ambient air. In one embodiment, a heat sink 5006 is attached to a fluid conduit 5002 to transfer or radiate heat from the fluid conduit to the surrounding environment. In a previous embodiment, the fluid conduit may also include an inlet 3004 and an outlet 3006, which may be connected to a pump 3008 or a blower to circulate the fluid.

[0386] In some embodiments of this technology, a thermoelectric cooler 5005, such as a Peltier cooler, may be provided. The thermoelectric cooler 5005 enables simultaneous heating and cooling. When a voltage is applied to the cooler 5005, the temperature of the first side 5005A decreases, and 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 polarity.

[0387] As one embodiment of this technology, the thermoelectric cooler 5005 may have a first side 5005A configured to engage with the fluid conduit 5002 to cool the fluid conduit 5002 when in use, and a second side 5005B configured to be attached to a heat sink 5006 that is in contact with the ambient air, or optionally in fluid communication with the ambient air, in order to dissipate heat from the thermoelectric cooler.

[0388] In some embodiments, a fan or other blower may be provided to improve air circulation over one or more of the fluid conduits 5002, thermoelectric coolers 5005, and / or heat sinks 5006. For example, the fan or blower may be an axial fan, a radial fan, or a piezo blower. In some embodiments, the blower may be provided by, for example, an RPT device 4000, and air circulation may be provided by, for example, an airflow drawn into the RPT device 4000 from an intake port, while in other embodiments, the airflow may be provided by air discharged through a ventilation section 3450 or other similar structure such as an anti-choking valve.

[0389] In the exemplary embodiment shown in Figure 11, the fluid conduit 5002 may be configured to expand from the inlet 3004 or outlet 3006 to increase the surface area for heat transfer, as described herein. 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 sloping taper 5010 to minimize or reduce fluid turbulence within the fluid conduit 5002.

[0390] In other embodiments of this technology, the heat sink 5006 and / or thermoelectric cooler 5005 may be configured to be directly attached to the reservoir during use or to be attached to the patient's forehead, as shown in Figure 8.

[0391] In the embodiment shown in Figure 12A, the thermoelectric cooler 5005 is configured to be thermally connected to the patient's forehead, and in some embodiments, is connected via a thermal interface material 6002. For example, the thermal interface material 6002 may be a gel or elastomer such as biocompatible silicone. Using a gel or elastomer can advantageously improve the rate of heat transfer from the patient's forehead to the reservoir or thermoelectric cooler 5005. In some embodiments, the thermal interface material may further function as a cushioning element that can at least partially conform to the shape of the patient's head, thereby improving patient comfort.

[0392] A heat sink is positioned opposite the thermoelectric cooler 5005, and this heat sink is connected to the thermoelectric cooler 5005 by an additional thermal interface material 6002, if necessary. It should be understood that the thermal interface material 6002 used for the heat sink does not need to meet the same comfort and biocompatibility requirements as the thermal interface material that comes into contact with the patient. For example, this thermal interface material may contain a metal oxide. 5.8.1.4 Air-assisted heat dissipation

[0393] In some embodiments, the airflow may be directed towards the patient's forehead. For example, this airflow may be provided by exhaust from the patient interface, supply air from the RPT device 4000, or air drawn into the RPT device through an intake port, for example. In other embodiments, the thermal interface material 6002 may be positioned on the patient's forehead, and the airflow (or a portion of the airflow) from the ventilation unit 3400 may be directed towards the outer surface (not in contact with the patient) of the thermal interface material 6002.

[0394] The thermal interface material 6002 can conduct heat to the airflow exhausted from the front and into the atmosphere. In some embodiments, the peripheral side of the thermal interface material 6002 may include design features that increase the surface area exposed to the flow path, for example, these design features may take the form of protrusions or fins within the material. Thus, the thermal interface material 6002 can function as a heat sink.

[0395] In some embodiments, the thermal conductive material may be formed from a composite of various materials, for example, the conductive material may be designed in a layered arrangement so that the layer in contact with the forehead has different properties from the layer exposed to the atmosphere. In this way, the contact layer material may be selected to be particularly biocompatible with the forehead, and the material properties may be designed to enhance comfort, for example, the hardness of the material in the layer in contact with the forehead may be set significantly lower than that of other layers of the conductive material.

[0396] In some embodiments of this technology, it may be beneficial to pass a fluid across the surface of the heat sink to further remove heat from the system. For example, the fluid may be supplied from a reservoir as described herein, or, if the forehead cooling technology is used in combination with a positive pressure (PAP) system, the airflow from the PAP system may be used to transfer heat from the heat sink.

[0397] For example, the flow of pressurized air from the RPT device 4000 may be configured to pass through the entire heatsink, removing heat from the heatsink and thereby removing heat from the patient's forehead. In other embodiments, the air ventilated from the patient interface may be configured to draw heat from the heatsink and, consequently, from the patient's forehead. For example, referring to Figure 12B, the patient interface 3000 may be configured to ventilate air "A" from the patient interface 3000 toward the patient's forehead, for example, by directing the airflow exhausted from the patient interface 3000 upward toward the forehead. As described herein, this exhausted air may be used to cool the forehead cooler 2000, such as a thermoelectric cooler 5005.

[0398] Similarly, referring to Figure 8A, the forehead cooling system 2000 may be configured to draw air from one or more of the air circuits 4170 for cooling the forehead and / or heatsink as described herein.

[0399] Therefore, one aspect of this technology utilizes the airflow from the ventilation section of the patient interface 3000 to drive or support a system that supplies forehead cooling to the patient.

[0400] The present invention, as described in any of the embodiments described above, can be adapted for use without PAP therapy by replacing the PAP airflow with an alternative airflow source such as an alternative blower or fan, or a compressed air source. In some embodiments, the amount of heat exchange can be controlled by controlling the flow rate. As in the previous embodiments, this can be used as a means to achieve a specific temperature profile over time, or as part of a control loop targeting a specific physiological effect. 5.8.1.5 Evaporative Cooling

[0401] In some embodiments, improved cooling performance can be achieved by employing the principle of evaporative cooling. In some embodiments, the layer of conductive medium exposed to the airflow may be made of a porous or absorbent material, so that water (or other fluid) can be soaked in it before bedtime, and when exposed to the airflow, the water begins to evaporate, and in this way, heat can be removed from the layer at a faster rate because the liquid molecules absorb energy during the phase change from liquid to solid. In some embodiments, the system may be equipped with a reservoir for replenishing the liquid as it evaporates. In some embodiments, there may be a wick material connecting the layer exposed to the reservoir to the reservoir, allowing the liquid to be transported from the reservoir. 5.8.2 Cooling Control

[0402] Figure 13 shows an embodiment of a state machine for controlling the temperature of a patient's forehead. In the exemplary embodiment, the state machine is associated with a thermoelectric cooler 5005, but this should not be considered limiting, as the logic for activating and deactivating the thermoelectric cooler could instead be applied to control fluid flow or to ventilate air toward the patient's forehead.

[0403] Referring to Figure 13, when the RPT device 4000 is activated, the thermoelectric cooler 5005 may be configured to transition from an off state, where the thermoelectric cooler is inactive, to an operating state, where the thermoelectric cooler actively cools the forehead of the patient 1000.

[0404] If the ambient temperature or the patient's forehead temperature is below a predetermined set temperature, such as 18-25°C, for example, about 20°C, the thermoelectric cooler 5005 may be configured to stop or otherwise become inactive until the ambient temperature is reached or the forehead temperature rises above the predetermined set temperature again. For example, the system may include a temperature sensor 8013 configured to provide a temperature measurement of the patient's forehead or an area adjacent to the patient's forehead.

[0405] In some embodiments, the thermoelectric cooler 5005 may be configured to have a second predetermined set temperature at which the operation of the thermoelectric cooler decreases and the cooling rate decreases, for example, the second predetermined set temperature being about 20 to 22°C, thereby causing the thermoelectric cooler 5005 to operate at a reduced rate between the first predetermined set temperature and the second predetermined set temperature. If the temperature is higher than the second predetermined set temperature, the thermoelectric cooler 5005 may be configured to operate normally in full power mode.

[0406] While the temperature of a patient's forehead can typically be 33-37°C, this technology can be configured to lower the temperature of the forehead to 14-18°C, or more preferably to a temperature in the mid-to-late teens, such as about 14°C or 15°C.

[0407] In some embodiments of this technology, lowering the forehead temperature to 14–18°C may not be practical, for example, due to reaching the thermodynamic limits of the cooling method used, or due to constraints of power, noise, size, or cost. Therefore, it may be advantageous to lower the forehead temperature below body temperature, including, for example, around 20–30°C.

[0408] In one embodiment, the technology is configured to lower the temperature of the forehead only during the period leading up to sleep. In other embodiments, the technology may be used throughout or for part of the patient's sleep period.

[0409] In some embodiments of this technology, for example, in a low-temperature environment, heat can be transferred to the forehead or other body parts using heat transfer technology.

[0410] In some embodiments of this technology, the cooling techniques described herein may be used to transfer heat from other parts of a patient's body or to cool them in other ways, for example, as a treatment for injuries or pain such as muscle soreness caused by overuse.

[0411] In some embodiments, a temperature sensor or sensor array (e.g., thermocouple) can be embedded in, in contact with, or in contact with the forehead to detect the forehead temperature. In some embodiments, a control loop can be established to target a specific temperature or temperature profile. For example, the airflow rate can be automatically increased or decreased to achieve the target temperature or temperature profile.

[0412] In some embodiments, the device may include a sensor 8013 that includes EEG, ECG, and / or EMG detection, and parameters from these signals may be used as control targets, for example, forehead cooling may be applied to reduce prefrontal cortical brain activity or heart rate. In some embodiments, cooling may be increased or decreased in response to the occurrence of rapid eye movements.

[0413] In other embodiments, the system designed herein may be configured to analyze the patient's respiratory waveform to determine sleep onset, and further to control the forehead cooling system, such as disabling the cooling function or lowering the target cooling temperature, once sleep onset is detected.

[0414] In some embodiments, the system can be used as part of a broader relaxation procedure, for example, while a patient practices meditation or deep breathing (or other relaxation techniques) before falling asleep, or synchronized with a guided relaxation procedure such as guided deep breathing or pharmacotherapy. 5.8.3 Humidification and Cooling

[0415] In another embodiment of this technology, a thermoelectric cooler 5005 can be used to raise the temperature of the fluid supply for humidification purposes while simultaneously lowering the temperature of the fluid supply for forehead cooling purposes. For example, referring to Figure 14, the thermoelectric cooler 5005 may have a first side 5005A that thermally engages with a first fluid 8002 and a second side 5005B that thermally engages with a second fluid 8004. For example, the first fluid may be configured to be in thermal contact with the patient's forehead, and the second fluid may be intended to be inhaled by the patient during use.

[0416] In this embodiment, the first fluid may be supplied to a first chamber or conduit, and the second fluid may be supplied to a second chamber or conduit.

[0417] In one embodiment, the first supply of fluid 8002 may be an airflow between the patient's forehead and the fluid. For example, the first supply of fluid may be configured to cool the patient's forehead directly, or to cool indirectly, such as by cooling a heat sink attached to the patient's forehead. In another embodiment, the first supply of fluid may be water or oil configured to cool the patient's forehead via the fluid transfer system described herein.

[0418] In one embodiment, the second fluid supply 8004 may be a breathable gas passing through one or more air circuits 4170. In another embodiment, the second fluid supply may include water used to humidify the airflow for the patient to breathe, and in yet another embodiment, the second fluid supply may include a humidified breathable gas. 5.8.4 Examples of exhausted airflow

[0419] In some embodiments of this technology, the air circuit 4170 may include a ventilation section 3400 or ventilation section opening 3402 configured to ventilate exhaled gas from the PAP system. Figure 70 shows one embodiment of the air circuit with a ventilation section. An improved version of this air circuit 4170 is shown in Figure 15A, in which a conduit 15000 is provided in the ventilation section, configured to direct the airflow (indicated by arrow A) upward towards the patient's forehead. In other words, the air circuit 4170 includes a conduit 15000 configured to direct a portion of the airflow towards the patient's forehead during use.

[0420] In the exemplary embodiments, the conduit 15000 is formed of rigid plastic and includes a curved outlet 15002 that is angled with respect to the longitudinal axis "L" of the conduit 15000. The curved outlet 15002 provides some directional control to the exhausted airflow, allowing the airflow to be returned towards the patient's face or forehead. In some embodiments, the air circuit 4170 may include an asphyxiation prevention valve (AAV) configured to selectively control the ventilation of air through the conduit 15000. Embodiments of the AAV are described in U.S. Patent Publication 2006 / 0076017A1, published April 13, 2006, and U.S. Patent Publication 2009 / 0065729A1, published March 13, 2009, which are incorporated herein by reference in their entirety.

[0421] For example, the AAV may be configured to ventilate air through the conduit 15000 only during the patient's exhalation. In other embodiments, the air circuit 4170 may be configured to continuously ventilate air through the conduit 15000 during use.

[0422] Figure 15B shows a further version of the air circuit 4170 configured to direct airflow toward the patient's forehead. In this embodiment, the conduit is located on the patient interface side of the isolation structure 15004, so that the positioning of the conduit remains substantially fixed relative to the patient interface, while the isolation structure 15004 allows the air circuit to pivot or rotate around the isolation structure 15004. Other forms of isolation structures, such as swivels or ball joints, should also be well known to those skilled in the art.

[0423] Figure 15C shows an embodiment of the air circuit of Figure 15A or 15B used in conjunction with a patient interface 3000 equipped with a nasal seal-forming structure 3100. It will be understood that the same air circuit 4170 can be used in the same way as the patient interface 3000 equipped with a seal-forming structure 3100 configured to deliver a breathable gas flow to both the patient's mouth and nasal airways when in use.

[0424] As shown in the figure, the conduit 15000 extends vertically from the air circuit 4170 toward the patient's forehead. In the recommended embodiment, the end of the conduit 15000 is positioned higher than the anterior part of the patient's nose so that the airflow does not disturb or irritate sensitive areas of the patient's nose and / or limit the amount of airflow passing over the patient's eyeballs.

[0425] In the illustrated embodiment, the conduit 15000 is positioned substantially centrally with respect to the patient's sagittal plane, thereby advantageously preventing or limiting dryness or irritation of the patient's eyes during use, i.e., the exhaust airflow is directed from between the patient's eyes towards the forehead region (in the direction generally shown by arrow A).

[0426] Figures 16A and 16B illustrate another embodiment of the present technology, in which a conduit 15000 is provided in the patient interface 3000 to guide air ventilated from the patient interface toward the patient's forehead. As in the previous embodiment, the conduit 15000 may include a curved outlet 15002 configured to provide some directional control of the exhausted airflow, thereby allowing the airflow to be returned toward the patient's face and forehead (in the direction indicated by arrow A). In each embodiment, it should be understood that the airflow through the conduit 15000 may be controlled by the ventilation unit 3400 as described herein.

[0427] Figure 16B shows an alternative design for the patient interface 3000, including a conduit 15000 configured to direct airflow to the patient's forehead. In this embodiment, the conduit 15000 is adjustablely connected to the patient interface, for example, via a support structure 15006 including a pivot 15008. This configuration allows for advantageous adjustment of the airflow direction to accommodate differences in patient physique.

[0428] In Figure 16B, the conduit is also spaced apart from the patient interface 3000. This allows for easy adjustment of the flow rate by changing the direction of the conduit to adjust the amount of airflow taken in from the ventilation unit 3450 (not shown in this example). This spatial relationship can also promote air mixing from the ambient air, resulting in an airflow delivered to the patient's forehead that is a mixture of exhausted air and ambient air. Since the exhausted air may be heated by the patient's exhalation and / or the RPT device 4000, mixing it with ambient air has the advantage of providing a cooler airflow, further promoting cooling of the patient's forehead.

[0429] Figure 16C shows a rear view of either the patient interface in Figure 16A or 16B, in which each of these embodiments the patient interface 3000 includes a shell 3210 which may be made of a plastic such as polycarbonate. The shell 3210 is connected to a seal-forming structure 3100 configured to deliver a breathable gas flow to the patient's nasal and oral airways.

[0430] The seal-forming structure 3100 in this embodiment includes a nasal portion 3230 which, when in use, is configured to engage with the surface of the underside of the patient's nose, for example, the anterior nasal portion, the nasal wings and upper lip on either side, and an oral portion 3260 which is configured to seal around the patient's oral airway when in use.

[0431] Further examples of this type of patient interface are described in PCT Publication No. WO2019183680A1, published on 3 October 2019, the entire contents of which are incorporated herein by reference.

[0432] In the exemplary embodiments, the conduit 15000 extends from the shell 3210 of the patient interface 3000 via a direct connection to the shell 3210 (including attachment to the shell, a detachable connection, or being molded as part of the shell) or at a distance from the shell 3210. In these embodiments, the shell 3210 may similarly be constructed from a rigid plastic such as polycarbonate or other suitable plastic material. This may favorably provide an airflow path between the plenum chamber 3200 and the patient's forehead.

[0433] Figure 17A illustrates a further embodiment of a “tube-up” system substantially identical to the system described in relation to Figure 7L. However, in this embodiment, the flow diverter 17000 is attached to the connection port 3600 to guide the airflow in a forward-downward direction toward the patient’s forehead (the direction generally indicated by arrow A). The flow diverter includes a conduit 15000 that curves along the contour of the patient’s head and guides the airflow in a forward-downward direction toward the patient’s forehead when in use.

[0434] In some embodiments, the flow diverter 17000 may be a detachable component that is detachably attached to the connection port 3600. For example, the flow diverter 17000 may be positioned between the connection port 3600 and an air circuit 4170 (not shown in Figure 17A) to receive the airflow from the RPT device 4000 and direct the airflow to the patient's forehead.

[0435] In other embodiments, the flow diverter 17000 may be provided as part of the connection port 3600. That is, the connection port 3600 may include a conduit 15000 configured to direct the airflow toward the patient's forehead.

[0436] Figure 17B shows a further embodiment of the flow diverter 17000, which may be connected to the connection port 3600. In this embodiment, the conduit 15000 is a flexible tube and may be repositioned as needed to direct airflow to a desired area of ​​the patient's forehead. In some embodiments, it may be advantageous for the conduit 15000 to retain its shape after being bent into a desired configuration; in other words, the material of the conduit may be selected to provide shape-retaining properties. For example, this may be provided by a flexible metal tube such as a bendable copper or aluminum tube, or the conduit may include a bellows or gooseneck portion, as commonly found in plastic straws, and in other embodiments, one or more swivel connectors may be provided on the conduit, thereby allowing one or more portions of the conduit to be manipulated relative to other portions.

[0437] In this embodiment, the positioning and stabilizing structure 3300 may include one or more attachments 17002 for holding the conduit 15000. For example, the attachments 17002 may be clips having receptacles configured to receive the conduit 15000, or they may provide other suitable fastening configurations such as hook-and-loop fasteners, domes and buckles.

[0438] Figure 17C shows a further embodiment of a tube-up configuration having an overall structure similar to that of Figures 17 and 7L. However, in this embodiment, the positioning and stabilizing structure 3300 includes a pair of opposing conduits 15000 configured to direct airflow inward (in the direction generally indicated by arrow A) toward the patient's forehead from the opposing sides 4171, 4172 of the positioning and stabilizing structure 3300. It will be understood that in some embodiments, only a single conduit may be used, for example, the positioning and stabilizing structure 3300 may be configured to direct airflow from one side of the positioning and stabilizing structure. 5.8.4.1 Compact ventilation design

[0439] Figures 18A to 18C show one embodiment of a compact ventilation unit 3450 with adjustable flow rate, configured to direct airflow from the patient interface 3000 to the patient's forehead.

[0440] In this embodiment, the ventilation unit 3450 includes a central component 3456 and an outer housing 3466. A primary ventilation path is provided in the gap 3464 between the central component 3456 and the outer housing 3466. By appropriately setting the size of this gap, a flow through this gap can be configured.

[0441] An aperture 18002 is provided in the side wall or groove 3416 of the outer component, so that when connected to the patient interface, the aperture 18002 faces the patient's forehead and functions as a conduit that directs a portion of the exhausted airflow passing through the side wall 3416 toward the patient's forehead during use.

[0442] In some embodiments, the central component 3456 may be rotatably connected to the outer housing 3466 and may include one or more flow control apertures 18000, of which various sizes may exist, as illustrated in Figure 18C, for example. During use, rotation of the central component 3456 adjusts the flow control apertures 18000 aligned with the aperture 18002 of the outer housing 3466, with larger apertures resulting in increased airflow and smaller apertures (or rotating the central component to a position where the aperture is not aligned) resulting in decreased or restricted airflow. Thus, by rotating the central component relative to the outer housing 3466, it may be possible to adjust the airflow directed towards the patient's forehead, as illustrated in Figure 18A. 5.8.5 Other Examples

[0443] Figure 19A shows an embodiment of system 19000, which includes a patient interface 3000 and a positioning and stabilizing structure 3300 configured to operate as an independent unit for delivering a breathable gas flow to the 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 seal-forming structure 3100. Further information relating to these types of systems is contained in PCT application PCT / AU2024 / 050419, filed 2 May 2024, which is incorporated herein by reference in its entirety.

[0444] In this embodiment, the system 19000 includes a conduit 15000 that is fluidly connected to a flow generator 6400 and configured to direct the airflow from the flow generator 6400 toward the patient's forehead in an upward and backward direction (the overall direction indicated by arrow A).

[0445] In another embodiment, the conduit 15000 may function as an air intake, drawing ambient air into the airflow generator 6400. By angling this conduit toward the user's forehead, the air intake can draw in air flowing forward and downward from the patient's forehead region, thereby cooling the patient's forehead during use.

[0446] In other embodiments, the airflow may be directed toward or drawn from the forehead region of the patient using any of the methods described herein, including, for example, using one or more conduits attached to the positioning and stabilizing structure 3300, as illustrated in Figure 19B. For example, the conduits may be fluidly connected to the flow generator 6400 via one or more air circuits (such as fiber air circuits) provided within or attached to the positioning and stabilizing structure.

[0447] Figure 20A shows another embodiment of the technology, which may incorporate a flow generator 6400 configured to generate a breathable gas flow, a seal-forming structure 3100 for delivering the breathable gas flow to the patient's airway, and a positioning and stabilizing structure 3300 configured to support these components on the patient's head during use. In this embodiment, the power supply 6020 is supplied via a cable from a power source such as an external battery, a USB port, or a plug pack.

[0448] In this embodiment of the technology, the positioning and stabilizing structure 3300 comprises a headband, a hoop 8378, or a ring configured to extend around the patient's head from the patient's frontal bone to the patient's occipital bone. In the exemplary embodiment, the hoop 8378 may be a continuous piece of material, but in other embodiments, the hoop 8378 may include a plurality of pieces that allow for adjustment of the length of the hoop 8378.

[0449] When in use, this hoop structure is configured to rest on the patient's forehead and therefore may comprise any of the forehead cooling systems 2000 described herein, including, but not limited to, an air cooling system, a fluid cooling system, a PCM material, and a thermoelectric cooling system.

[0450] In some embodiments, the hoop 8378 may include one or more sensors 8013 configured to measure one or more characteristics of a patient. For example, this may include temperature, humidity, heart rate, or electroencephalogram (EEG) sensors. Such sensors 8013 may be configured to relay patient information to a controller to control one or more operating parameters of the system, such as active cooling of the forehead region or flow characteristics.

[0451] Although not an essential component of the present invention, the apparatus in this embodiment also comprises an audio system 6800, which includes a pair of output devices 6804. Each output device 6804 can output sound to one of the patient's ears. In the exemplary embodiment, the output devices 6804 are formed as earmuffs and can be placed on and / or enclosed in each of the patient's ears. In other embodiments (not shown), the output devices 6804 may be earphones that fit into the patient's ears. These audio systems can be integrated with the control systems described herein to provide auditory stimuli that aid in falling asleep, such as white noise, and auditory stimuli that aid in waking the patient, such as alarms or nature sounds, at appropriate times or at appropriate parts of the patient's sleep cycle (such as during light sleep).

[0452] Detailed information relating to these types of systems and devices is contained in PCT application PCT / AU2024 / 050419, filed on 2 May 2024, the entire contents of which are incorporated herein by reference.

[0453] Figure 20B shows another embodiment of the technology that may provide the forehead cooling system 2000 described herein in the absence of respiratory therapy technology. For example, one or more of the forehead cooling systems 2000 may be mounted on a positioning and stabilizing structure 3300, such as a headband or hoop 8378.

[0454] Figure 20C shows a top-down view of a forehead cooling system 2000 provided in engagement with the forehead of a patient 1000. In this embodiment, the forehead cooling system includes a housing 20002 mounted on a positioning and stabilization structure 3300. The housing includes a blower 20004 configured to circulate an airflow through the housing to cool the user's forehead when in use. The blower 20004 may be an axial-flow blower, a piezo-flow blower, or another form of blower well known to those skilled in the art.

[0455] The housing is provided with an inlet 20006 through which airflow passes during use, and one or more outlets 20008A, 20008B. This airflow can be in any direction, namely, drawn in across the patient's forehead and discharged upward or forward outward relative to the patient's head, or drawn in from the front of the patient's forehead, crosses the forehead, and discharged laterally relative to the forehead.

[0456] In some embodiments, the forehead cooling system may further include one or more sensors 8013 configured to measure the user's moisture level, temperature, heart rate, or provide electroencephalogram (EEG) information. For example, the sensors may include thermocouples, EEG electrodes, and / or electrooculogram (EOG) electrodes.

[0457] The control of the forehead cooling system 2000 may be carried out using any of the methods described herein. For example, in one embodiment, the forehead cooling system 2000 may adjust the flow of the blower 20004 to maintain a target forehead temperature.

[0458] In some embodiments, it may be beneficial to determine the patient's sleep state and set the target temperature control accordingly. For example, it may be advantageous to provide a low target temperature, such as approximately 15°C, and an appropriate blower speed 20004 to reach this temperature before the patient falls asleep. For example, the blower speed 20004 may be determined based on the ambient temperature and the user's forehead temperature, so that a higher blower speed 20004 is used when the difference between the target temperature and the measured temperature is maximum, and a lower speed is used when the difference from the target temperature is small, such as within 0-3 degrees.

[0459] If sleep is detected, it may be beneficial to target a second temperature different from the first target temperature. For example, the second temperature may be higher than the temperature used before falling asleep. For example, the second temperature may be approximately 20°C. Furthermore, it may be beneficial to limit the speed of the blower 20004 to reduce the noise and vibration generated.

[0460] In some embodiments of this technology, it may be beneficial to set the target temperature and / or blower speed based on the depth of the user's sleep. For example, a lower set temperature may be used if it is detected that the forehead is warm, or if it is detected that the brain activity level is high. Furthermore, it may be beneficial to set the target temperature and fan speed based on the detection of one or more sleep states, such as wakefulness, N1, N2, N3, or REM sleep. For example, a first target temperature in the wakeful sleep state, a second target temperature in the N1 sleep state, a third target temperature in the N2 sleep state, a fourth target temperature in the N3 sleep state, and a fifth target temperature in the REM sleep state.

[0461] In some embodiments of this technology, it may be beneficial to control the cooling force based on the blower speed, or, in the case of a thermoelectric cooler, the ambient temperature in the environment.

[0462] In some embodiments, it may also be beneficial to estimate the heat transfer coefficient based on the measured or estimated forehead temperature, and the changes in these temperatures in response to the target temperature change and / or the change in blower speed. The estimated heat transfer coefficient can then be used to adjust the blower speed, or, in the case of a thermoelectric cooler, to adjust the cooling capacity based on the estimated heat transfer coefficient / efficiency of the forehead cooling system 2000.

[0463] In some embodiments, the blower speed can be adjusted by adjusting the power or control (such as PWM control) to the blower 20004. In other embodiments, the flow path can be modified using a flow diverter. That is, the inlet 20006 and / or outlets 20008A, 20008B can be modified to control the effective cooling of the forehead during use.

[0464] Figures 21A and 21B illustrate another embodiment of the technology in which the forehead cooling system 2000 described herein may be applied to other applications such as virtual reality (VR), augmented reality (AR), and mixed reality (XR) systems (referred to herein as VR devices for ease of explanation). In this embodiment, the VR device 12000 includes a flow generator 6400 configured to generate a breathable gas flow into the patient's airway via a seal-forming structure 3100, along with typical VR device features such as a display 12070 configured to present images or video feeds for the patient to view during treatment.

[0465] The VR device 12000 includes a forehead support 12100, which can 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 condition / temperature of the forehead during use. Since the VR device 12000 is already positioned in the area in contact with the patient's forehead, the forehead can be cooled simultaneously by incorporating the forehead cooling system 2000 described herein.

[0466] In another embodiment, a portion of the airflow generated by or drawn into the flow generator 6400 may be directed / drawn out to the patient's forehead region using the conduit 15000, as described herein. In yet another embodiment, the cushion 12100 that contacts the patient's forehead may be provided with the PCM material or thermoelectric cooler described herein.

[0467] In Figures 21A and 21B, the VR device 12000 includes a patient interface 3000, but this is not essential to the present technology. For example, the VR device 12000 may include a forehead cooling system 2000 without requiring a patient interface.

[0468] This specification describes several forehead cooling systems 2000, and it should be understood that one or more of these systems 2000 can be combined with any of the other systems 2000 described herein. For example, a contact forehead cooling system described in relation to any of Figures 8A to 814, 20A, or 20B may be combined with a non-contact forehead cooling system in any of Figures 15A to 19B. In other embodiments, multiple contact coolers may be combined, for example, with a thermoelectric cooler 5005 and a fluid cooler, such as the one described in relation to Figures 8A to 10. In further embodiments, multiple non-contact forehead cooling systems can be combined, for example, with an airflow in any of Figures 15A to 16C or any of Figures 18A to 19B and an airflow from an air circuit 4170 or connection port 3600 described in relation to Figures 17A to 17C.

[0469] Therefore, one aspect of this technology relates to an RPT system that combines two or more forehead cooling systems 2000 described herein. 5.8.6 Control System

[0470] Figure 22A shows an exemplary system 9000 that may be implemented to monitor sleep, provide insights and / or recommendations, and / or control the operation of the forehead cooling system described herein. System 9000 may generally include one or more servers 9010, one or more communication networks 9030, and one or more computing devices 9040. The servers 9010 and computing devices 9040 may also communicate with one or more respiratory therapy devices (e.g., RPT device 4000, sensor 8013, and forehead cooling system 2000, but not limited to those described herein) via one or more communication networks 9030.

[0471] One or more communication networks 9030 may include, for example, the Internet, a local area network, a wide area network, and / or a personal area network implemented via a wired communication network(s) 9032, a wireless communication network(s) 9034, or a combination thereof (e.g., a wired network with a wireless link). In one embodiment, the local communication network may utilize one or more communication standards such as Bluetooth, Near Field Communication (NFC), or Consumer Infrared Protocol.

[0472] The server 9010 may comprise processing equipment such as one or more processors 9012, memory 9014, and other configuration elements typically present in such computing environments. The processing power of the processor 9012 may be provided, for example, by one or more general-purpose processors, one or more dedicated processors, or by a cloud computing service that provides access to a shared pool of computing resources configured according to desired characteristics, service models, and deployment models. In the exemplary embodiment, the memory 9014 stores information accessible by the processor 9012, which includes instructions 9016 that can be executed by the processor 9012 and data 9018 that can be retrieved, manipulated, or stored by the processor 9012. The memory 9014 may be any preferred means known in the art that can store information in a manner accessible to the processor 9012, including computer-readable media or other media that store data that can be read with the help of electronic devices. Although the processor 9012 and memory 9014 are illustrated as being located within a single unit, this is not intended to be restrictive. It should be understood that each function described herein may be performed by multiple processors and memories, and that these processors and memories may or may not be separated from each other or from the rest of the system 9000.

[0473] 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 in accordance with instruction 9016. Data 9018 may also be formatted in any suitable computer-readable format. Again, although the data is illustrated as being stored in a single location, it should be noted that this is not intended to be restrictive; that is, data may be stored in multiple memories or locations. Data 9018 may include one or more databases 9020.

[0474] In some embodiments, the server 9010 can communicate unidirectionally with one or more computing devices 9040 by providing information to one or more of the computing devices 9040, or vice versa. In other embodiments, the server 9010 and the computing devices 9040 can communicate bidirectionally with each other and share information and / or processing tasks. 5.8.6.1 Computing Devices

[0475] The computing device(s) 9040 may be any suitable processing device, but is 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 tablet 9046. Figure 22B shows an exemplary general architecture 9100 of the computing device 9040. The foregoing description concerns components of the computing device that are equivalent to, or could be identical to, the server components described in relation to Figure 22A, but different reference numbers are used for the computing device components for ease of understanding.

[0476] The computing device 9040 may include one or more processors 9110. The computing device 9040 may also include memory / data storage 9120, input / output (I / O) devices 9130, and communication interfaces 9150.

[0477] One or more processors 9110 may include functional placement elements used for executing instructions, such as functional placement elements for fetching control instructions from a location such as memory / data storage 9120, decoding program instructions, executing program instructions, and writing the results of executed instructions.

[0478] The memory / data storage 9120 may be the internal memory of a computing device, such as RAM, flash memory, or ROM. In some embodiments, the memory / data storage 9120 may also be external memory linked to the computing device 9040, such as an SD card, USB flash drive, optical disc, or remotely located memory (accessed via a server, such as server 9010). In other embodiments, the memory / data storage 9120 may be a combination of external and internal memory.

[0479] The memory / data storage 9120 includes processor control instructions 9122 and stored data 9124 that instruct the processor 9110 to perform a particular task, as described herein. As described above, in the embodiment, the instructions may be executed by a resource associated with a server 9010 that communicates with a computing device 9040, and the data may be stored by and / or accessed from such resource.

[0480] In the embodiment, the input / output (I / O) device 9130 may include one or more displays 9132. In the embodiment, the display 9132 may be a touch-sensitive screen that allows user input in addition to outputting visible information to the user of the computing device 9040. In the embodiment, the I / O device may include other output devices, including one or more speakers 9134 and a haptic feedback device 9136. In the embodiment, the input / output (I / O) device 9130 may include input devices such as a physical input device 9138 (such as a button or switch), a sensor 8013 including, for example, an optical sensor 9140 (such as one or more imaging devices such as a camera), a sound sensor or audio input device (such as a microphone that allows a patient to control the device using their voice or sound), and an inertial sensor 9142 (especially in embodiments where the computing device 9040 is a mobile computing device). It will be understood that other I / O devices 9130 may be included or may be accessed separately through the I / O interface 9150 (for example, by interfacing with peripheral devices connected to the computing device 9040). The communication interface 9160 allows the computing device 9040 to communicate through one or more networks 9030. 5.8.6.2 Computer-implementable methods

[0481] Computer-readable instructions may implement the exemplary methods described herein. In embodiments, computer-readable instructions include one or more algorithms executed by one or more of the processors 9012 described herein. Instructions for performing these functions are optionally contained in a non-transient computer-readable storage medium, e.g., memory 9014, or other computer program products configured to be executed by one or more processors 9012. The computer-readable storage medium may be a tangible device capable of holding and storing instructions for use by an instruction execution device. The computer-readable storage medium may be, but is 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 preferred combination thereof. As used herein, the computer-readable storage medium is not construed as transient signals themselves, such as freely propagating electromagnetic waves like radio waves, electromagnetic waves propagating through a transmission medium like a waveguide, or electrical signals transmitted through a wire.

[0482] However, it will be readily apparent to those skilled in the art that the entire algorithm and / or parts thereof can be implemented by devices other than the processor and / or can be included in firmware or dedicated hardware in known ways (e.g., 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 components may 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 exemplary algorithm has been described with reference to the illustrated flowchart, it will be readily apparent to those skilled in the art that many other methods can be used as alternatives to implement the exemplary processor-readable instructions. For example, the execution order of blocks can be changed and / or some of the described blocks can be modified, deleted, or combined.

[0483] As used herein, the terms “component,” “module,” and “system” generally mean entities relating to a computer, hardware (e.g., circuits), combinations of hardware and software, software, or entities relating to an operable machine having one or more specific functions. For example, a component may be, but is not limited to, a process running on a processor, a processor, an object, an executable file, an execution thread, a program, and / or a computer. Exemplarily, both an application running on a controller and a controller may be components. One or more components may reside within a running process and / or thread, components may be localized on one computer and / or distributed across two or more computers. Furthermore, “device” may be in the form of specially designed hardware, generalized hardware in which the hardware is specialized by the execution of software capable of performing a specific function, software stored on a processor-readable medium, or a combination thereof. 5.8.6.3 Support for circadian rhythms

[0484] In embodiments of this technology, the forehead cooling system 2000 described herein may be controlled to support an individual's healthy sleep cycle. For example, in the early stages of the sleep cycle, the forehead may be actively cooled to aid in falling asleep. Then, once sleep is detected, the cooling may be temporarily paused (or reduced).

[0485] There are several methods for detecting sleep onset, including, but not limited to, monitoring of the patient's biosignals (i.e., using one or more sensors 8013, such as heart rate or electroencephalogram sensors) or monitoring of the patient's respiratory waveform.

[0486] In some embodiments, the system may be configured to detect situations in which the patient wakes up at night, and in these embodiments, the system may detect this event and perform a process of cooling the forehead again to assist in falling asleep.

[0487] In the early morning, a forehead cooling system can be used to assist in awakening the patient, for example, according to an alarm set on a mobile device, or as a natural part of the patient's sleep cycle. For example, if a thermoelectric cooling system is used, the polarity of the voltage can be reversed to warm the patient's head in order to assist in awakening.

[0488] Figure 23 shows an embodiment of a control system configured to control the forehead cooling system described herein. As shown, the system is powered on or activated by the patient. This may be when the device is first operated, or, in the case of an RPT device, when the delivery of pressurized breathable gas is activated.

[0489] Once activated, the system is configured to begin collecting patient information from one or more sensors 8013. For example, this may include forehead temperature measurement, heart rate measurement, respiratory waveform, and so on.

[0490] Next, this information is compared against a set of predefined rules for control. For example, this could include detecting: Whether the patient is awake, and whether the forehead temperature is above, within, or below a predefined threshold.

[0491] Whether the patient is asleep, and whether the forehead cooling system should be deactivated, activated at low power, or configured to target a predefined sleep temperature range.

[0492] The control system is configured to perform an operation if any of the predefined rule conditions are met. For example, it controls the forehead cooling system according to a predefined rule.

[0493] Predefined rules are available to the user from a list of pre-configured settings; for example, a setting to keep cooling active at night may be provided, and an alternative setting to disable cooling when sleep is detected may be provided.

[0494] In other embodiments, predefined rules may be automatically adjusted over time. For example, if higher quality sleep is detected under certain conditions (e.g., by monitoring respiration, heart rate, body temperature, and / or EEG data), those conditions may be automatically learned and repeated in subsequent nights. Conversely, if sleep deprivation is detected, the system may be configured to activate a forehead cooling system, such as by cooling the forehead to better regulate the patient's sleep.

[0495] In some embodiments, predefined rules can be automatically adjusted in response to environmental changes such as ambient temperature or ambient noise levels. For example, on a night when the ambient temperature is 27°C, the system may be configured to set the cooling temperature to 15°C and the sleep temperature to 20-25°C. On a night when the ambient temperature is 22°C, the system may be configured to set the cooling temperature to 15°C and the sleep temperature to 18-22°C.

[0496] In another embodiment, the target temperature profile may change during the night, for example, to match the patient's detected sleep stage. This allows for appropriate target temperature and lamp settings as needed. 5.8.6.4 User Control and Feedback

[0497] Figure 24 shows an embodiment of a personal computing device 9040, such as a smartphone. The computing device 9040 may be configured to allow a patient to monitor and control their preferred sleep profile by, for example, adjusting predefined rules as described herein. In some embodiments, this control function may instead be provided by a user interface on the RPT device 4000.

[0498] In the exemplary embodiment, the computing device 9040 is configured to present the patient / user with a list of configurable settings, which can be adjusted as needed to modify the predefined rules considered by the cooling system described herein. For example, the user may configure setting a target sleep duration, a sleep temperature, configuring automatic sleep onset detection, enabling wake-up alarms including auditory and preheating options, whether cooling is needed during sleep, whether to provide white noise to aid sleep, and whether to automatically adapt settings during use. The above is not intended to be an exhaustive list, and in some embodiments, an advanced settings menu may be provided to allow the user to set advanced parameters such as a target temperature range and heating and cooling ramp settings.

[0499] In some embodiments, the computing device 9040 may also provide the patient / user with detailed information regarding the quality, duration, and effectiveness of the forehead cooling system 2000 described herein. For example, to determine the effectiveness of one or more of the provided settings for the system described herein, it may be beneficial to capture user sleep information under various conditions, such as the presence or absence of forehead cooling, auditory stimulation, or respiratory pressure therapy.

[0500] Embodiments of this technology provide a forehead cooling system 2000 that can be manually adjusted / controlled by a patient 1000. For example, with respect to Figures 18A-18C, manual adjustment may be performed by rotating the central component 3456 relative to the outer housing 3466. However, in other embodiments of this technology, cooling control may be performed using one or more of the following: for example, by closing or restricting a portion of the conduit or by diverting a portion of the flow through the conduit 15000; by directing the flow through the conduit 15000 (i.e., by changing the direction of the airflow or adjusting the cooling or heating force (if a thermoelectric cooler 5005 is used)); for example, by controlling the flow velocity or flow rate using an RPT device 4000 or flow generator, or a personal computing device communicating with the RPT device 4000 or flow generator.

[0501] In other embodiments, the systems described herein include control devices such as sliders, knobs, dials, and proximity or contact-sensing interfaces, through which patient 1000 can control the device, for example, by increasing or decreasing a temperature setpoint or adjusting the flow rate.

[0502] In some embodiments of this technology, the forehead cooling system 2000 may be controlled using one or more voice commands such as “lower temperature,” “stop cooling,” or “increase flow rate.” For example, as described herein, the forehead cooling system or associated processor 9012 (such as an RPT device 4000, a flow generator, or a processor in a personal computer) may be connected to a microphone-type sensor 8013 configured for voice capture. This voice is processed by the processor 9012, which may perform control operations, such as controlling the operation of the forehead cooling system 2000 in response to the instructions.

[0503] By allowing the patient to directly control the forehead cooling system 2000, this technology is more comfortable for the patient 1000 and can increase compliance with all therapies offered by the forehead cooling system 2000. When manual control is provided, the patient can easily make adjustments, for example, while lying in bed, without having to navigate complex menus, which further enhances the ease of use of the system described herein.

[0504] In some embodiments of this technology, manual control may function to override pre-configured therapeutic settings. For example, these manual settings may replace existing settings, or the system may be configured to revert to pre-configured settings when a change in sleep state is detected. For example, the system may be configured to revert to a pre-configured state after falling asleep or when the patient enters N1, N2, N3, or REM sleep.

[0505] In some embodiments, override settings may only affect settings that are active while the patient is awake.

[0506] If users can adjust their settings, it can be advantageous to make these settings persistent, meaning they are maintained across sessions.

[0507] Each control device may be used in conjunction with one or more of the forehead cooling systems described herein. For example, when a thermoelectric cooler 5005 is used, these settings may be used to adjust cooling setpoints, temperature ramp rates, etc. In embodiments where a fluid flow (such as water or airflow) is used, the control device may be configured to adjust the flow velocity, flow rate, temperature, direction, or timing.

[0508] 5.9 Glossary For the purposes of disclosing this technology, one or more of the following definitions may apply in certain forms of this technology. In other forms of this technology, alternative definitions may apply. 5.9.1 Overview

[0509] Air: In certain forms of this technology, air may be considered to mean the atmosphere, and in other forms of this technology, air may be considered to mean any other combination of some breathable gases, such as oxygen-enriched air.

[0510] Surroundings: In certain forms of this technology, the term surroundings is considered to mean (i) outside the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0511] For example, the ambient humidity for a humidifier could be the humidity of the air directly surrounding the humidifier, such as the humidity of the room where the patient is sleeping. Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0512] In another embodiment, ambient pressure may be pressure directly surrounding the body or outside the body.

[0513] In certain contexts, ambient (e.g., acoustic) noise can be considered the background noise level of the room in which the patient is located, excluding noise generated by, for example, an RPT device, or noise originating from a mask or patient interface. Ambient noise may originate from sound sources outside the room.

[0514] Automatic positive airway pressure (APAP) therapy: This is a type of CPAP therapy that can automatically adjust the therapeutic pressure between the minimum and maximum limits between breaths, for example, depending on the presence or absence of signs of SDB onset.

[0515] Continuous positive airway pressure (CPAP) therapy is a respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway entrance increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure fluctuates between different respiratory cycles of the patient (for example, increasing in response to the detection of signs of partial upper airway obstruction and decreasing if signs of partial upper airway obstruction are not present).

[0516] Flow rate: The amount (or mass) of air discharged per unit time. Flow rate can refer to an instantaneous quantity. In some cases, when flow rate is mentioned, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, a reference to flow rate is a reference to a vector quantity (i.e., a quantity that has both magnitude and direction). The symbol Q may be assigned to flow rate. "Flow rate" may be simply written as "flow" or "airflow".

[0517] In the case of patient respiration, 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 exiting the RPT device. Total flow rate Qt is the flow rate of air reaching the patient interface via the air circuit, plus any supplemental gases. Ventilation flow rate Qv is the flow rate of air exiting the ventilation unit to wash out expiratory gases. Leakage flow rate Ql is the flow rate leaking from the patient interface system, etc. Respiratory flow rate Qr is the flow rate of air received by the patient's respiratory system.

[0518] Flow therapy is a respiratory therapy that involves delivering air to the airway entrance at a controlled flow rate called therapeutic flow rate, which is typically positive throughout the patient's entire respiratory cycle.

[0519] Humidifier: The term humidifier is interpreted as a humidifying device that has a physical structure capable of supplying a therapeutically beneficial amount of water (H2O) vapor to the airflow in order to improve a patient's medical respiratory condition.

[0520] Leakage: The term "leakage" refers to an unintended airflow. In one embodiment, leakage may occur as a result of an incomplete seal between the mask and the patient's face. In another embodiment, leakage may occur in a swirling elbow.

[0521] Conducted noise (acoustics): In this document, conducted noise refers to noise transmitted to a patient via an air pressure path (e.g., air circuits and patient interfaces and the air within them). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0522] Radiated noise (acoustics): In this specification, radiated noise refers to noise transmitted to the patient by the surrounding air. In one embodiment, radiated noise can be quantified by measuring the acoustic power / pressure level of the object in question in accordance with ISO 3744.

[0523] Ventilation (acoustic) noise: In this specification, ventilation noise refers to noise generated by airflow passing through any ventilation opening, such as a vent in the patient interface.

[0524] Oxygen-enriched air: Air with a higher oxygen concentration than the atmosphere (21%), such as at least approximately 50%, at least approximately 60%, at least approximately 70%, at least approximately 80%, at least approximately 90%, at least approximately 95%, at least approximately 98%, or at least approximately 99% oxygen. "Oxygen-enriched air" is sometimes abbreviated as "oxygen."

[0525] Medical oxygen: Medical oxygen refers to oxygen-enriched air with an oxygen concentration of 80% or higher.

[0526] Patient: A person, regardless of whether they have a respiratory illness or not.

[0527] Pressure: Force per unit area. Pressure is expressed as cmH2O, gf / cm². 2 It can be expressed in a variety of units, including hectopascals. 1 cmH2O is 1 g-f / cm³. 2 This is equivalent to approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m³). 2 (=1 millibar to 0.001 atm). Unless otherwise specified, pressure is given in cmH2O.

[0528] The pressure at the patient interface is denoted with Pm, and the therapeutic pressure, which indicates the target value to be achieved at the current interface pressure Pm, is denoted with Pt.

[0529] Respiratory pressure therapy: This involves supplying air to the airway opening at a therapeutic pressure that is usually positive relative to atmospheric pressure.

[0530] Ventilator: A mechanical device that provides pressure assistance to a patient to perform some or all of the breathing function. 5.9.1.1 Materials and their properties

[0531] (Durometer hardness (indentation hardness): A material property measured by the indentation of an indenter (measured according to ASTM D2240).

[0532] • The "soft" material may include silicone or thermoplastic elastomer (TPE), which can be easily deformed, for example, under finger pressure.

[0533] "Hard" materials may include polycarbonate and polypropylene, for example, materials that cannot be easily deformed under finger pressure.

[0534] Silicone or silicone elastomer: synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of approximately 35 to approximately 45, as measured using ASTM D2240.

[0535] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate. 5.9.1.2 Mechanics

[0536] shaft: a. Neutral axis: The axis of a cross-section of a beam or plate in which there is no stress or strain in the longitudinal direction.

[0537] b. Vertical axis: An axis that extends along the length of a figure. The axis usually passes through the center of the figure.

[0538] c. Circumferential axis: An axis perpendicular to the vertical axis. The axis may exist in particular in pipes, tubes, cylinders, or similar shapes having a circular and / or elliptical cross-section.

[0539] Deformation: The process by which a member's original shape changes when a force, such as a force applied in the direction of its axis, is applied. This process may include stretching or compression, bending, and twisting.

[0540] Elasticity: The ability of a material to return to its original shape after deformation.

[0541] Floppy structure or component: A structure or component whose shape changes (e.g., curves) within a relatively short period of time (e.g., 1 second) when it is able to support its own weight.

[0542] Elasticity: The ability of a material to absorb energy during elastic deformation and release energy when the load is released.

[0543] Elasticity: When unloaded, virtually all energy is released. This includes, for example, certain silicon and thermoplastic elastomers.

[0544] Rigid structure or component: A structure or component whose shape does not substantially change when subjected to loads typically encountered during use. In one embodiment of such use, for example, a patient interface can be installed and maintained in a sealing relationship with the entry point to the patient's airway at a load pressure of about 20-30 cmH2O.

[0545] In one embodiment, an I-beam may have different bending stiffness (resistance to bending load) in the first direction compared to a second orthogonal direction. In another embodiment, a structure or component may be flexible in the first direction and rigid in the second direction.

[0546] 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 may be a force or moment (e.g., compression, tension, bending, or torsion). A structure or component may provide different resistances in different directions. The opposite of stiffness is flexibility.

[0547] Viscosity: The ability of a material to resist flow.

[0548] Viscoelasticity: The ability of a material to exhibit both elastic and viscous behavior during deformation.

[0549] Yield: The condition in which a material cannot return to its original shape after deformation. 5.9.1.3 Structural elements

[0550] Compression member: A structural element that is subjected to compressive force.

[0551] Elbow: An elbow is an example of a structure that guides the axis of airflow to change direction at an angle. In one embodiment, the angle may be approximately 90 degrees. In another embodiment, the angle may be greater than or less than 90 degrees. An elbow may have a substantially circular cross-section. In another embodiment, an elbow may have an elliptical or rectangular cross-section. In a particular embodiment, an elbow may be rotatable, for example, about 360 degrees relative to a meshing component. In a particular embodiment, an elbow may be detachable from a meshing component, for example, via a snap connection. In a particular embodiment, an elbow may be assembled to a meshing component via a one-time snap during manufacturing, but cannot be detached.

[0552] Frame: A frame is a mask structure that receives tensile loads between two or more connection points with the headgear. The mask frame can be an airtight load-bearing structure within the mask. However, some forms of mask frames can be airtight.

[0553] Membrane: A membrane is interpreted to mean a typically thin element that preferably has virtually no resistance to bending but does have resistance to stretching.

[0554] Thai (noun): A structure designed to withstand tension.

[0555] Thin structure: a. Beam: i. In a beam, one dimension may be relatively long compared to the other two dimensions, in which case the smaller dimension will be relatively thin compared to the longer dimension. b. Membrane: i. Relatively long in two dimensions, with one dimension being thin. Easily deforms in response to bending forces. Resists stretching (and may also resist compression).

[0556] c. Plates and shells i. These may be relatively long in two directions and narrower in one direction. They may have bending, tensile, and / or compressive stiffness.

[0557] Thick structure: solid Seal: When used as a noun ("seal"), it can refer to a structure; when used as a verb ("to seal"), it can refer to its effect. Two elements can be constructed and / or arranged to "seal" each other or produce a "sealing" effect without requiring a separate "seal" element itself.

[0558] Shell: The term "shell" is used to mean a curved, relatively thin-walled structure with bending, tensile, and compressive rigidity. For example, the curved structural walls of a mask can be a shell. In some forms, the shell can be faceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0559] Stiffener: A stiffener can be understood as a structural component designed to increase the bending resistance of another component in at least one direction.

[0560] Support: A support can be understood as a structural component designed to increase the compressive strength of another component in at least one direction.

[0561] Swivel section (noun): A subassembly of components configured to rotate preferably independently around a common axis, preferably under low torque. In another embodiment, the swivel section may be configured to rotate at an angle of 360 degrees or more. In another embodiment, the swivel section may be configured to rotate at an angle of less than 360 degrees. When used in conjunction with an air delivery conduit, the subassembly of components preferably includes a matched pair of cylindrical conduits. During use, there may be little to no leakage of airflow from the swivel section. 5.9.2 Anatomy 5.9.2.1 Facial Anatomy

[0562] Alar: The outer wall of each nostril or "wing" (plural: alar).

[0563] Wing angle: The angle formed between the wings of each nostril.

[0564] Outermost point of the nasal ala: The outermost point of the nasal ala.

[0565] Alar bend (or ala apex) point: The last point on the baseline of the bend of each ala, located within the fold formed by the junction of the ala and cheek.

[0566] Auricle: The entire part of the ear that is visible from the outside.

[0567] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0568] (Nasal) cartilage skeleton: The cartilage skeleton of the nose includes the nasal septum cartilage, lateral nasal cartilage, greater nasal cartilage, and lesser nasal cartilage.

[0569] Columella: A strip of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0570] Columella angle: The angle between a line drawn through the midpoint of the nostril opening and a line drawn perpendicular to the Frankfort horizontal plane, intersecting the area below the nose.

[0571] Frankfort horizontal plane: A line extending from the lowest point of the orbital rim to the left tragus point. The tragus point is the deepest point of the depression above the tragus of the atrial appendage.

[0572] Nasal root: Located on soft tissue, it is the point where the midline sagittal plane of the forehead protrudes the most.

[0573] Lateral nasal cartilage: This is a cartilaginous plate that usually has a triangular shape. Its upper edge connects to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the cartilage of the large nasal ala.

[0574] Lower lip (lower lip dot): The lip that extends between the nose and the mouth.

[0575] Upper lip (upper lip point): The lip that extends between the mouth and the nasal alar cartilage.

[0576] Greater alar cartilage: A plate of cartilage located beneath the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is connected to the premaxillary process of the maxilla by a tough fibrous membrane containing three or four small cartilages of the alar cartilage.

[0577] Nostrils: The nearly elongated oval openings that form the entrance to the nasal cavity. The singular form of nostril is nostril. The nostrils are separated by the nasal septum.

[0578] Nasolabial folds or laugh lines: Wrinkles or grooves of skin that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0579] Nasolabial angle: The angle between the columella and the upper lip, where it intersects with the area below the nose.

[0580] Infraauricular point: The lowest point where the auricle attaches to the facial skin.

[0581] Superior basement point: The highest point where the auricle meets the skin of the face.

[0582] Nasal tip: The most prominent point or tip of the nose, which can be identified when viewed from the side of the rest of the head.

[0583] Philtrum: The groove along the midline of the upper lip, extending from the lower edge of the nasal septum to the upper part of the lip.

[0584] Mental point: A point located in the soft tissue at the very front center of the jaw.

[0585] Nasal ridge: The nasal ridge is a projection along the midline of the nose, extending from the alae of the nose to the tip of the nose.

[0586] Sagittal plane: The vertical plane from front (forward) to back (backward). The mesosagittal plane is the sagittal plane that divides the body into left and right halves.

[0587] Nasal root point: The most indented point located on soft tissue, covering the frontonasal suture region.

[0588] Nasal septal cartilage (nose): The nasal septal cartilage forms part of the nasal septum and separates the anterior part of the nasal cavity.

[0589] Lowest point of the nasal ala: The point on the lower edge of the nasal ala, where the base of the nasal ala meets the skin of the upper lip.

[0590] Infranasal point: Located on soft tissue, this is the point where the columella connects to the upper lip in the midline sagittal plane.

[0591] Splamenton: The largest depression in the midline of the lower lip, between the lower lip and the soft tissue process. Skull Anatomy Frontal bone: The frontal bone contains a large vertical section called the frontal squamous region, which corresponds to the area known as the forehead.

[0592] Mandible: The mandible forms the lower jaw. The mental protuberance is a protrusion on the jawbone that forms the jaw.

[0593] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbit. The frontal process of the maxilla projects upward on the side of the nose and forms part of its lateral boundary.

[0594] Nasal bones: The nasal bones are two small rectangular bones that vary in size and shape from individual to individual. They are positioned side by side in the upper center of the face, and their joint forms the "beam" of the nose.

[0595] Nasal root point: The indented area where the frontal bone and the two nasal bones intersect, located between the eyes and just above the bridge of the nose.

[0596] Occipital bone: The occipital bone is located at the back and base of the skull. The skull has an oval-shaped opening called the foramen magnum, through which the cranial cavity and the spinal canal are connected. The curved plate behind the foramen magnum is the occipital squama.

[0597] Orbit: The cavity in the skull that houses the eyeball.

[0598] Parietal bone: The parietal bones are connected bones that, when fused together, form the top and sides of the skull.

[0599] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the temples of the face.

[0600] Cheekbones: The face contains two cheekbones, located on the upper and sides of the face, forming the cheek protrusions. 5.9.2.2 Anatomy of the Respiratory System

[0601] Diaphragm: A sheet of muscle that spans the bottom of the thoracic cavity. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases, and air is drawn into the lungs.

[0602] Larynx: The larynx, or vocal organ, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0603] Lungs: The human respiratory system. The conduction zone of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory region includes respiratory bronchioles, alveolar ducts, and alveoli.

[0604] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space located in the center of the face, above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On either side of the nasal cavity are three horizontal projections called the nasal conchae (singular "concha") or nasal turbinates. The nose is located anterior to the nasal cavity, and it connects posteriorly to the nasopharynx via the nostrils.

[0605] The pharynx is the part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is usually divided into three parts: the nasopharynx (the nasal part of the pharynx), the mesopharynx (the oral part of the pharynx), and the hypopharynx. 5.9.3 Patient Interface

[0606] Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that reduces the risk of a patient rebreathing carbon monoxide (CO2) by releasing into the atmosphere in a fail-safe manner.

[0607] Headgear: Headgear can be understood as a form of positioning and stabilizing structure designed to hold devices such as masks on the head.

[0608] Plenum Chamber: A mask plenum chamber is understood as part of a patient interface having walls that at least partially occupy a spatial volume of air that is pressurized to a pressure higher than atmospheric pressure when in use. The shell may form part of the walls of the mask plenum chamber.

[0609] Seal: When used as a noun ("seal"), it can refer to a structure; when used as a verb ("to seal"), it can refer to its effect. Two elements can be constructed and / or arranged to "seal" each other or produce a "sealing" effect without requiring a separate "seal" element itself.

[0610] Ventilation section (noun): A structure that allows airflow from inside the mask or conduit to the surrounding air, clinically effective in washing out exhaled gases. For example, in clinically effective exhalation, flow rates of approximately 10 liters / min to 100 liters / min may be used, depending on the mask design and treatment pressure. 5.10 Other Notes

[0611] Some of the disclosures in this patent document are protected by copyright. The copyright holder retains all copyright to any copies made by anyone in this patent document or disclosure, except for those intended for inclusion in the patent files or records of the Japan Patent Office.

[0612] Unless otherwise explicitly indicated by the context, if a range of values ​​is provided, it is understood that each intervening value up to one-tenth of the lower limit unit between the upper and lower limits of that range, and any other stated values ​​or intervening values ​​within that range, are included in this technique. Even if the upper and lower limits of these intervention ranges, independently included within the intervention range, specifically exceed the limits in the stated range, they are also included in this technique. If the stated range includes one or both of these limits, the range exceeding either or both of these stated limits is also included in this technique.

[0613] Furthermore, where one or more values ​​are described herein as being implemented as part of the Technology, unless otherwise stated, it will be understood that such values ​​may be approximations and may be used with any appropriate significant figures to the extent that a practical technical implementation may permit or require it.

[0614] Furthermore, as used herein, “approximately,” “substantially,” “about,” or similar terms mean ±5 to 10% of the value mentioned.

[0615] Unless otherwise defined, all technical and scientific terms used herein have the same meanings as those generally understood by those skilled in the art. Any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this art, but only a limited number of exemplary methods and materials are described herein.

[0616] While certain materials are described as suitably used for constructing components, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise specified, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or individually.

[0617] Note that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents unless the context clearly indicates otherwise.

[0618] All publications referenced herein are incorporated herein by reference to disclose and describe the methods and / or materials that are the subject matter of those publications. The published documents mentioned herein are provided solely for their disclosures prior to the filing date of this application. Nothing in this specification should be construed as acknowledging that the present art does not precede such published documents for the purpose of prior patents. Furthermore, the dates of the published documents mentioned herein may differ from the actual publication dates and may require individual verification.

[0619] The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that the elements, components, or steps described may exist, be used, or be combined with other elements, components, or steps not explicitly stated.

[0620] The headings used in the detailed descriptions are for the convenience of the reader and should not be used to limit the content found in this disclosure or the claims as a whole. These headings shall not be used in the interpretation of the scope of the claims or the limitations of the claims.

[0621] While the techniques described herein have been referred to with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may indicate specific details that are not necessary for carrying out the techniques. For example, the terms “first” and “second” are used, but unless otherwise specified, these terms are not intended to indicate any arbitrary order and are used to distinguish separate elements. Furthermore, while the descriptions or examples of process steps in the methods may be given in order, such order is not mandatory. Those skilled in the art will understand that such order is changeable and / or that these actions can be performed simultaneously or even synchronously.

[0622] Therefore, it should be understood that many modifications can be made to the exemplary examples, and other configurations can be designed without deviating from the spirit and scope of the technology.

Claims

1. A patient interface configured to deliver a breathable gas stream to a patient for the treatment of a respiratory disease, During use, the patient's respiratory cycle should be maintained at least 4 cmH above ambient atmospheric pressure throughout the entire respiratory cycle. ２ A plenum chamber pressurized to high therapeutic pressure, comprising a seal-forming structure constructed and positioned to form a seal with the area of ​​the patient's face surrounding at least one entrance to the patient's airway, A positioning and stabilizing structure configured to hold the seal-forming structure at the patient's face position during use, A forehead cooling system configured to cool the patient's forehead during use, A patient interface comprising the above.

2. The patient interface according to claim 1, wherein the forehead cooling system includes a conduit configured to direct airflow to the patient's forehead when in use.

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

4. The patient interface according to claim 2 or 3, wherein the conduit is connected to the plenum chamber and configured to guide the airflow from the plenum chamber toward the patient's forehead.

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

6. The patient interface according to claim 2 or 3, wherein the conduit is provided in the positioning and stabilizing structure.

7. The patient interface according to claim 6, wherein the first conduit is fluidly connected to the first side of the positioning and stabilizing structure in a region above the patient's eyeball.

8. The patient interface according to claim 6 or 7, further comprising a second conduit positioned on the second opposing side of the positioning and stabilizing structure in a region above the patient's eyeball.

9. The patient interface according to claim 8, wherein the first conduit is fluidly connected to the second conduit by a semipermeable material configured to ventilate an airflow over the patient's forehead.

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

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

12. The patient interface according to claim 11, wherein the fluid reservoir comprises one or more of water, oil, gel, or sodium polyacrylate.

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

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

15. The patient interface according to any one of claims 1 to 14, wherein the forehead cooling system includes a thermal interface material positioned to contact the patient's forehead during use.

16. The patient interface according to any one of claims 1 to 15, wherein the forehead cooling system includes a heat sink.

17. A method for controlling a forehead cooling system, A) A step of monitoring the temperature of the patient's forehead, B) If the temperature of the forehead exceeds a first predetermined threshold, the step of activating the forehead cooler, C) If the temperature of the forehead portion is below a second predetermined threshold, the step of deactivating the forehead cooler, A method that includes the following:

18. The method according to claim 17, wherein the frontal cooler includes a thermoelectric cooler.

19. The method according to claim 17 or 18, wherein the first predetermined threshold is 20 to 30°C.

20. The method according to any one of claims 17 to 19, wherein the first predetermined threshold is substantially equal to 25°C.

21. The method according to any one of claims 17 to 20, wherein the second predetermined threshold is 15 to 20°C.

22. The method according to any one of claims 17 to 21, wherein the second predetermined threshold is substantially equal to 18°C.

23. The method according to any one of claims 17 to 22, wherein the frontal cooler may include a first active mode and a second active mode, the first active mode providing a first cooling rate, and the second active mode providing a second cooling rate lower than that of the first active mode.

24. The method according to 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 less than a third predetermined threshold, and to switch from the second active mode to the first active mode when the forehead temperature exceeds the third predetermined threshold.

25. The method according to claim 24, wherein the third predetermined threshold is 20 to 22°C.

26. The method according to any one of claims 17 to 25, wherein the forehead cooling system is activated only during the sleep onset phase and becomes inactive when the patient is detected to be in a sleep state.

27. The method according to any one of claims 17 to 26, wherein the forehead cooling system is configured to raise the temperature of the patient's forehead as part of an awakening routine.

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