Patient interface with blowout preventer for seal-forming portion

Abstract

One form of this technology includes a sealing structure for sealing around the user's airway against the user's face. The sealing structure includes a sheet or membrane extending inward toward the user's airway and includes a structure that prevents the inner boundary of the sheet or membrane from being ejected outward due to internal pressure (e.g., folded back onto itself).

Description

[0001] This application is a divisional application of patent application number 201680028551.6, filed on March 24, 2016, entitled "Patient Interface with Spray-Proof Component for Sealing Formation". Patent application 201680028551.6 is the application for entry into the Chinese national phase of PCT international application PCT / AU2016 / 050228.

[0002] 1. Cross-references to related applications

[0003] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 138,009, filed March 25, 2015, and U.S. Provisional Patent Application No. 62 / 222,503, filed September 23, 2015, the entire contents of which are incorporated herein by reference. Background Technology 2.1 Technical Field

[0005] This technology relates to the detection, diagnosis, treatment, prevention, and improvement of one or more respiratory-related disorders. This technology also relates to medical devices or equipment and their uses.

[0006] 2.2 Description of relevant technologies

[0007] 2.2.1 The Human Respiratory System and Its Disorders

[0008] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0009] The airways consist of a series of branching tracheae, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from inhaled air and carbon dioxide to be expelled in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually branch into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Other branches of the airways lead to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, by John B. West, Lippincott Williams & Wilkins, 2012.

[0010] A range of breathing disorders are present. Some disorders can be characterized by specific events, such as respiratory arrest, insufficiency, and hyperventilation.

[0011] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disease.

[0012] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. This condition causes the affected patient to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can result in cardiovascular disease and brain damage. Concomitant symptoms are common, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0013] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Because of the repetitive oxygen deprivation, CSR can be harmful. In some patients, CSR is associated with repetitive microarousing from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Sullivan).

[0014] Respiratory failure is a broad term encompassing respiratory disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure may include some or all of the following disorders.

[0015] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0016] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0017] Chronic obstructive pulmonary disease (COPD) includes any of a group of lower airway diseases that share certain common characteristics. These diseases include increased airflow resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include shortness of breath during exercise, chronic cough, and sputum production.

[0018] Neuromuscular disease (NMD) is a broad term encompassing many diseases and disorders that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage lasting more than several months and leading to death within a few years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD)); (ii) variable or slowly progressive diseases: characterized by worsening muscle damage lasting more than several years and only slightly shortening life expectancy (e.g., limb-girdle muscular dystrophy, facial-shoulder-arm muscular dystrophy, and myotonic dystrophy). Symptoms of respiratory failure in NMD include: progressive general weakness, difficulty swallowing, shortness of breath during exercise and at rest, fatigue, drowsiness, morning headache, difficulty concentrating, and mood changes.

[0019] Chest wall disorders are a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and carry the potential for chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0020] A range of treatments have been used to treat or alleviate these conditions. Furthermore, these treatments can be used by other healthy individuals to prevent respiratory distress. However, these treatments have many drawbacks.

[0021] 2.2.2 Treatment

[0022] Various therapies, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), and invasive ventilation (IV), have been used to treat one or more of the above-mentioned respiratory disorders.

[0023] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and prevents upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to comply if they find the device used to provide this treatment uncomfortable, difficult to use, expensive, or unsightly.

[0024] Non-invasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is delivered via a non-invasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as OHS, COPD, NMD, and chest wall diseases. In some forms, it can improve the comfort and effectiveness of these treatments.

[0025] Invasive ventilation (IV) provides ventilatory support for patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0026] 2.2.3 Treatment System

[0027] These treatments can be provided by treatment systems or devices. Such systems and devices can also be used to diagnose conditions without treating them.

[0028] The treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0029] Another type of treatment system is the mandibular repositioning device.

[0030] 2.2.3.1 Patient Interface

[0031] A patient interface can be used to attach a breathing device to its wearer, for example, by providing an airflow into the airway. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to deliver gas at a positive pressure of approximately 10 cmH2O into the airway.

[0032] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain suitable pressure. Masks for underwater swimming or diving may be constructed to prevent water from flowing in from external high pressure, rather than maintaining air at a pressure higher than the environment inside.

[0033] Some masks may be clinically disadvantageous for this technology, for example, because they block airflow through the nose and only allow it to pass through the mouth.

[0034] If certain masks require patients to insert a portion of the mask structure into their mouths to form and maintain a seal through their lips, they may be uncomfortable or not feasible for this technology.

[0035] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0036] The design of the patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly from person to person. Because the head comprises bones, cartilage, and soft tissues, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during the duration of respiratory therapy.

[0037] Due to these challenges, some face shields suffer from one or more of the following problems: protrusion, unsightly appearance, high cost, mismatched size, difficulty in use, and discomfort, especially when worn for extended periods or when the patient is unfamiliar with the system. Wrongly sized face shields can lead to decreased compliance, reduced comfort, and adverse patient outcomes. Face shields designed solely for pilots, designed as part of personal protective equipment (e.g., filtering face shields), SCUBA face shields, or face shields designed for administering anesthetics are acceptable for their original purpose, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient compliance with treatment, especially if the face shield is worn during sleep.

[0038] Assuming patient compliance, CPAP therapy is very effective in treating certain breathing difficulties. Patients may not comply if the mask is uncomfortable or difficult to use. Since patients are generally advised to wash their masks regularly, they may not wash their masks if they are difficult to clean (e.g., difficult to assemble or disassemble), which could affect patient compliance.

[0039] While masks designed for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0040] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0041] 2.2.3.1.1 Sealing Formation Part

[0042] The patient interface may include a seal-forming portion. Because it comes into direct contact with the patient's face, the shape and construction of the seal-forming portion can directly affect the effectiveness and comfort of the patient interface.

[0043] The patient interface is partially characterized according to the design intent of the sealing portion to engage with the face during use. In one form of patient interface, the sealing portion may include a first sub-part to form a seal around the left nostril and a second sub-part to form a seal around the right nostril. In another form of patient interface, the sealing portion may include a single element surrounding both nostrils during use. Such a single element may be designed, for example, to cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing portion may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing portion may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0044] A seal that works effectively in one area of ​​a patient's face may not be suitable for another, for example, due to the different shapes, structures, variations, and sensitive areas of the patient's face. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0045] Certain seal-forming components can be designed for mass production, making a design suitable, comfortable, and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the shape of the patient's face and the seal-forming components of the mass-produced patient interface, one or both must be adapted to form a seal.

[0046] One type of seal-forming portion extends around the periphery of a patient interface and, when force is applied to the patient interface while the seal-forming portion engages face-to-face with the patient's face, serves to seal the patient's face. The seal-forming portion may include an air or fluid-filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer (e.g., rubber). With this type of seal-forming portion, if the fit is insufficient, a gap will exist between the seal-forming portion and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0047] Another type of seal-forming part includes a sheet-like seal of thin material positioned around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied inside the mask. Similar to the previous type of seal-forming part, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming part does not match the patient's shape, it may wrinkle or bend during use, leading to leakage.

[0048] Another type of sealing component may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0049] Another form of sealant can be achieved using adhesives. Some patients may find it inconvenient to constantly apply and remove adhesives from their face.

[0050] A series of patient interface sealing technologies are disclosed in the following patent applications assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785.

[0051] One form of nasal pillow is found in Adam Circuit, manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett.

[0052] ResMed Limited has manufactured the following products, including nose pillows: SWIFT TM Nose pillow mask, SWIFT TM II Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX nose pillow mask and SWIFT TM LIBERTY TMFull-face mask. The following patent application assigned to ResMed Ltd. describes an example of a nose pillow mask: International Patent Application WO2004 / 073,778 (which describes a ResMed Ltd. SWIFT mask). TM Other aspects of the nose pillow), U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc.'s SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO2005 / 063,328 and WO2006 / 130,903 (which describe ResMed Ltd. MIRAGE LIBERTY) TM Other aspects of full-face masks); International Patent Application WO2009 / 052,560 (which describes ResMed Ltd.'s SWIFT...) TM Other aspects of the FX nose pillow).

[0053] 2.2.3.1.2 Positioning and Stability

[0054] The sealing portion of the patient interface used in positive air pressure therapy is subjected to the corresponding force of air pressure to disrupt the seal. Therefore, various techniques have been used to position the sealing portion and maintain it in a sealed relationship with the appropriate part of the face.

[0055] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, using adhesives may be uncomfortable for some people.

[0056] Another technique involves using one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following problems: unsuitability, bulkiness, discomfort, and difficulty in use.

[0057] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0058] Respiratory pressure therapy (RPT) devices can be used to deliver one or more of the many therapies mentioned above, such as by generating an airflow for delivery to the airway inlet. This airflow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0059] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, medical air pressure generators have specific requirements that are not met by more general air pressure generators, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0060] One example of a specific requirement for certain RPT devices is noise.

[0061] Noise output level table for existing RPT devices (only one sample, measured in CPAP mode using the test method specified in ISO 3744 at 10 cmH2O).

[0062]

[0063] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed. Another example of an RPT device is a ventilator. Ventilators such as the ResMed Stellar™ series of adult and pediatric ventilators can provide invasive and non-invasive, non-dependent ventilation support for a range of patients to treat various conditions, including but not limited to NMD, OHS, and COPD.

[0064] The ResMed Elisée™ 150 and ResMed VS III™ ventilators provide support for invasive and non-invasive air-dependent ventilation (RTP) suitable for adult or pediatric patients for the treatment of a variety of conditions. These ventilators offer volumetric and pressure-dependent ventilation modes with single-channel or dual-channel circuits. RPT devices typically include a pressure generator, such as an electric blower or a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, airflow to the patient's airway can be supplied under positive pressure. The RPT device outlet is connected via an air circuit to a patient interface such as those described above.

[0065] The designer of the device may have provided an almost limitless number of options to make. Design standards often conflict, meaning that some design choices are far from conventional or unavoidable. In addition, certain aspects of comfort and efficiency may be highly sensitive to small and subtle changes in one or more parameters.

[0066] 2.2.3.3 Humidifier

[0067] Delivering an unhumidified airflow can lead to airway dryness. Using a humidifier with an RPT device and patient interface produces humidified gas, minimizing dryness of the nasal mucosa and increasing patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air.

[0068] A range of artificial humidification devices and systems are known, however they may not meet the specific requirements of medical humidifiers.

[0069] Medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to ambient air when needed, typically in areas where patients may sleep or rest (e.g., in hospitals). Medical humidifiers intended for bedside placement can be very small. Medical humidifiers can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed by the patient; however, these systems also humidify and / or heat the entire room, which can cause discomfort to the occupant. Furthermore, medical humidifiers may have stricter safety restrictions than industrial humidifiers.

[0070] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers provide insufficient humidification, and some may be difficult or inconvenient for patients to use.

[0071] 2.2.3.4 Data Management

[0072] There are many clinical reasons to obtain data to determine whether a patient is “compliant” with a prescription for respiratory therapy, such as if the patient has been using their RPT device according to certain “compliance rules.” One example of a compliance rule for CPAP therapy is that, in order to ensure patient compliance, the patient is required to use the RPT device for at least four hours each night for at least 21 or 30 consecutive days. To determine patient compliance, RPT device providers, such as healthcare providers, can manually obtain data describing the patient’s use of the RPT device, calculate usage over the predetermined time period, and compare it to the compliance rules. Once the healthcare provider has determined that the patient has been using their RPT device according to compliance criteria, the healthcare provider can inform the patient of the third part of the compliance process.

[0073] Patient treatment can benefit from other aspects of communication of treatment data to third parties or external systems.

[0074] Existing methods for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0075] 2.2.3.5 Mandibular repositioning

[0076] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance, available from a dentist or other vendor, that holds the lower jaw (mandible) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes after falling asleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom-made or manufactured in standard form and include occlusal impression portions designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, applies tension to the pharyngeal walls to reduce airway constriction, and reduces vibration of the hard palate.

[0077] In some instances, a mandibular advancement device may include an upper splint designed to engage or engage with teeth in the maxilla or mandible, and a lower splint designed to engage or engage with teeth in the maxilla or mandible. The upper and lower splints are laterally connected together by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper and lower splints.

[0078] In this design, the length of the connecting rod is chosen so that the mandible remains in an advanced position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the degree of mandibular protrusion. The dentist can determine the degree of mandibular protrusion, which will then determine the length of the connecting rod.

[0079] Some MRDs are configured to push the mandible forward relative to the maxilla, while others (such as ResMed NarvalCC™ MRDs) are designed to keep the mandible in an anterior position. The device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. Therefore, it is constructed to minimize or prevent any movement of one or more teeth.

[0080] 2.2.3.6 Exhaust Port Technology

[0081] Some forms of patient interface systems may include vents to allow the flushing of exhaled carbon dioxide. Vents allow gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the external space of the patient interface, such as into the environment.

[0082] Exhaust vents may include orifices through which gas can flow when a mask is in use. Many such vents are noisy. Others may become blocked during use, thus providing insufficient flushing. Some vents can, for example, disrupt the sleep of the patient's bed partner by causing noise or congested airflow.

[0083] ResMed has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; and U.S. Patent Application Publication No. US2009 / 0044808.

[0084] The noise level of the existing face mask (ISO17510-2:2007, pressure of 10 cmH2O at 1m).

[0085]

[0086] (*This is a single sample only, measured in CPAP mode using the test method specified in ISO 3744 at 10 cmH2O).

[0087] The sound pressure levels of various objects are shown below.

[0088]

[0089] 2.2.4 Diagnostic and Monitoring System

[0090] Polysomnography (PSG) is a routine system used for the diagnosis and monitoring of cardiopulmonary diseases and typically involves specialized clinical healthcare professionals applying the system. PSG usually involves placing 15 to 20 contact sensors on the body to record various bodily signals, such as electroencephalograms (EEG), electrocardiograms (ECG), electrooculograms (EOG), and electromyograms (EMG). PSG for sleep-disordered breathing has involved two nights of observation of the patient in the clinic: one night for pure diagnosis and a second night for the clinician to determine treatment parameters. PSG is therefore expensive and inconvenient. Specifically, it is not suitable for home sleep testing.

[0091] Clinicians can appropriately diagnose or monitor patients based on visual observation of PSG signals. However, there are situations where clinicians may be unavailable or unaffordable. Different clinicians may have differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. Summary of the Invention

[0092] This technology aims to provide medical devices for diagnosing, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0093] The first aspect of this technology relates to devices for diagnosing, improving, treating, or preventing respiratory disorders.

[0094] Another aspect of this technology relates to methods for diagnosing, improving, treating, or preventing respiratory disorders.

[0095] One aspect of this technology in certain forms is used to provide methods and / or devices for improving patient compliance with respiratory therapy.

[0096] One aspect of this technology relates to a patient interface comprising: an inflatable chamber pressurizable to a therapeutic pressure exceeding ambient pressure by at least 6 cmH2O, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an airflow for patient respiration at the therapeutic pressure; a sealing structure configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, such that the airflow is delivered to an inlet at least the patient's nostrils at the therapeutic pressure, the seal being formed to prevent air from escaping from the inflatable chamber between the sealing structure and the region of the patient's face, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflatable chamber during use throughout the patient's respiratory cycle; and a positioning and stabilizing structure for use when the patient is in a lateral sleeping position and in… When the patient is in a supine sleeping position, the sealing structure is held in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes low-profile sides and a low-profile rear. A flushing and venting structure is configured to allow a continuous flow of exhaust gas from the interior of the inflatable chamber to the environment when the pressure within the chamber is positive relative to the environment. The venting structure is configured such that the exhaust flow rate has an amount sufficient to help reduce rebreathing of exhaled CO2 during both patient inhalation and exhalation, while maintaining the therapeutic pressure within the inflatable chamber in use. The sealing structure includes a sealing surface that forms a seal against the patient's face during use. The sealing structure includes a tether extending between a first inner surface region of the sealing structure opposite the sealing surface and a second inner surface region of the patient interface, such that the tether resists deformation of the sealing structure.

[0097] In the example, (a) the sealing structure may include a second inner surface region spaced apart from the first inner surface region; (b) the inflation chamber may include a second inner surface region spaced apart from the first inner surface region; (c) the tether and the sealing structure may comprise an integral structure formed of a homogeneous material; (d) the homogeneous material may be silicone rubber; (e) the silicone rubber may be liquid silicone rubber or compression-molded silicone rubber; (f) the sealing structure may include a sealing strip at an edge region, the sealing strip being shaped and positioned to seal at least one side of the patient's nose in use, and the sealing strip being thinner than adjacent areas of the sealing structure; (g) the first inner surface region may be adjacent to the sealing strip such that the tether and the sealing strip are inwardly aligned. (h) The frenulum may extend continuously from the sealing structure at the edge region such that the frenulum forms an extension of the sealing surface; (i) The frenulum may include an inner surface, and the sealing structure may include an inner surface; (j) The inner surface of the frenulum is adjacent to and separate from the inner surface of the sealing structure; (k) The air chamber may be made of a transparent material; (l) The patient interface may be configured such that no part of the patient interface structure enters the mouth during use; (m) The sealing structure may be configured such that it does not extend inside the patient's airway during use; (n) The sealing structure may be configured such that it does not extend below the mental protuberance region during use; and / or (o) The air chamber may be configured such that it does not cover the eyes during use.

[0098] Another aspect of this technology relates to a component for a patient interface, the component comprising: an inflation chamber pressurizable to a therapeutic pressure exceeding ambient pressure by at least 6 cmH2O, the inflation chamber including an inflation chamber inlet port sized and configured to receive an airflow for patient breathing at the therapeutic pressure; and a sealing structure configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, such that the airflow is delivered to an inlet of at least the patient's nostrils at the therapeutic pressure, the seal being formed to prevent air from escaping from the inflation chamber between the sealing structure and the region of the patient's face, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use; wherein the sealing structure includes a sealing surface that forms the seal against the patient's face during use, wherein the sealing structure includes a connecting portion extending between a first inner surface region of the sealing structure opposite the sealing surface and a second inner surface region of the component, such that the connecting portion resists deformation of the sealing structure.

[0099] In the example, (a) the sealing structure may include a second inner surface region spaced apart from the first inner surface region; (b) the inflation chamber may include a second inner surface region spaced apart from the first inner surface region; (c) the connecting portion and the sealing structure may include an integral structure formed of a homogeneous material; (d) the homogeneous material may be silicone rubber; (e) the silicone rubber may be liquid silicone rubber or compression molded silicone rubber; (f) the sealing structure may include a sealing strip at an edge region, the sealing strip being shaped and positioned to seal at least one side of the patient's nose in use, and the sealing strip being thinner than adjacent areas of the sealing structure; (g) the first inner surface region may be adjacent to the sealing strip such that the connecting portion and the sealing structure... The sealing strips are spaced inwards; (h) the connecting portion may extend continuously from the sealing structure at the edge region such that the connecting portion forms an extension of the sealing surface; (i) the connecting portion may include an inner surface, and the sealing structure may include an inner surface, the inner surface of the connecting portion being adjacent to and separate from the inner surface of the sealing structure; (j) the inflation chamber may be made of a transparent material; (k) the assembly may be configured such that no part of the assembly enters the mouth during use; (l) the sealing structure may be configured such that it does not extend inside the patient's airway during use; (m) the sealing structure may be configured such that it does not extend below the mental protuberance region during use; and / or (n) the inflation chamber is configured such that it does not cover the eyes during use.

[0100] One form of this technology includes a sealing structure for sealing around the user's airway against the user's face. The sealing structure includes a sheet or membrane extending inward toward the user's airway and includes an attachment structure that prevents the inner boundary of the sheet or membrane from being blown outward due to internal pressure (e.g., folded back onto itself).

[0101] In an example, the attachment structure may include: one or more ribs / straps / connecting portions / connecting structures, a sheet extending from the membrane and folded inward to attach to another structure to form a tube or ring, or a tube under the membrane and attached to the membrane.

[0102] Another aspect of this technology is a sealing structure for a patient interface for sealingly delivering an airflow to the inlet of the patient's airway (including at least the inlet of the patient's nostrils) under a continuous positive pressure relative to ambient atmospheric pressure. The patient interface is configured to, when used, maintain a therapeutic pressure within a range of approximately 3 cmH2O to approximately 40 cmH2O above ambient atmospheric pressure throughout the patient's respiratory cycle during sleep, to improve sleep-disordered breathing. The sealing structure includes: a sealing surface configured to form a seal around the periphery of the inlet of the patient's airway; and a ring that folds the sealing structure inward from its outer periphery to form a substantially tubular structure such that the ring is continuous, the ring including a portion of the sealing surface.

[0103] In an embodiment, (a) the sealing structure further includes a sealing tab projecting toward the inner periphery of the sealing structure; (b) the sealing tab is configured to form a seal against the sides of the nose above the nasal bone of a patient; (c) the sealing tab is configured to avoid sealing against the alar; (d) a portion of the sealing surface has increased flexibility relative to the remainder of the ring, the portion of the sealing surface including a wall segment thinner than the remainder of the ring; (e) the portion of the sealing surface including a wall segment thicker than the remainder of the ring; (f) the ring is positioned to contact the sidewall of the nose including the alar; (g) the ring provides a continuous surface configured to maintain contact with the sides of the nose above the nasal bone of a patient; (h) the ring includes at least one closed end; and (i) the ring folds the sealing structure inward. (j) A connection point is formed on the inner surface of the sealing structure; (k) the connection point is positioned relative to the sealing surface to provide sufficient tension to the ring to counteract outward ejection of the sealing surface when therapeutic pressure is applied to the inner surface of the ring; (l) the ring forms a predetermined angle at the connection point, and the predetermined angle determines the tension in the ring when therapeutic pressure is applied; (m) the connection point is adjustable; (n) the connection point is a releasable connector; (o) the sealing structure further includes a second connection point; (p) the sealing surface includes a friction-reducing region to reduce adhesion to the patient's face; (q) the friction-reducing region is a frosted surface; and (r) the friction-reducing region is adapted to allow the sides of the patient's nose to slide freely against the sealing surface; and / or (r) the ring provides a rimless sealing surface.

[0104] Another aspect of this technology is a patient interface for sealingly delivering an airflow to the inlet of the patient's airway (including at least the inlet of the patient's nostrils) under a continuous positive pressure relative to ambient atmospheric pressure. The patient interface is configured to maintain a therapeutic pressure within a range of approximately 3 cmH2O to approximately 40 cmH2O above ambient atmospheric pressure throughout the patient's respiratory cycle during sleep, in order to improve sleep-disordered breathing. The patient interface includes a sealing structure to seal the patient interface against the patient's face. The sealing structure includes a sealing surface configured to form a seal around the periphery of the inlet of the patient's airway; and a ring that folds the sealing structure inward from its outer periphery to form a substantially tubular structure such that the ring is continuous, the ring including a portion of the sealing surface. The patient interface also includes a positioning and stabilizing structure for maintaining a sealed contact between the sealing structure and the area surrounding the inlet of the patient airway, while maintaining a therapeutic pressure at the inlet of the patient airway; an inflation chamber pressurized during use at a pressure exceeding ambient pressure; and a gas flushing vent configured to allow exhaled CO2 from the patient to flow to the outside of the patient interface to minimize rebreathing of exhaled CO2.

[0105] In the example, (a) the sealing strip protrudes toward the inner periphery of the sealing structure, (b) the sealing strip is configured to form a seal against the sides of the nose above the nasal bone and adjacent to the sides of the nose above the maxilla in a recess near the patient's inner canthus, (c) the sealing strip is configured to avoid sealing against the alar, (d) the portion of the sealing surface has increased flexibility relative to the remainder of the ring, (e) the portion of the sealing surface includes a wall section thinner than the remainder of the ring, (f) the portion of the sealing surface includes a wall section thicker than the remainder of the ring, (g) the sealing surface includes a friction-reducing region to reduce adhesion to the patient's face, (h) the friction-reducing region is a frosted surface, (i) the friction-reducing region is adapted to allow the sides of the patient's nose to slide freely against the sealing surface, (j) the first ring defines the The sealing structure is adapted to contact the patient's face, (k) the first and second portions are part of the area of ​​the sealing structure adapted to contact the patient's face, (1) the first ring is continuous, (m) the second ring is positioned to contact the patient's nose or adjacent to the patient's nose; (n) the second ring is positioned such that the substantially tubular structure is adapted to contact the patient's nose or is positioned adjacent to the patient's nose, (o) the substantially tubular structure is adapted to be positioned substantially parallel to one side of the patient's nose, (p) the sealing structure further includes a second of the second ring, (g) the substantially tubular structure includes a hollow interior adapted to communicate with a pressure fluid exceeding ambient pressure, (r) the substantially tubular structure includes two open ends, and / or (s) the second ring is adapted to prevent the second ring from being ejected when the patient interface is pressurized internally and adjusted by the patient.

[0106] Another aspect of this technology is a patient interface for sealingly delivering an airflow to the inlet of a patient's airway (including at least the inlet of the patient's nostrils) under a continuous positive pressure relative to ambient air pressure. The patient interface is configured to maintain a therapeutic pressure within a range of approximately 3 cmH2O to approximately 40 cmH2O above ambient air pressure throughout the patient's respiratory cycle during sleep, in order to improve sleep-disordered breathing. The patient interface includes a sealing structure for sealing the patient interface against the patient's face. The sealing structure includes a facial contact portion adapted to make peripheral contact around the inlet of the patient's airway; and at least a first substantially cylindrical region having an uninterrupted circumference, a portion of which includes a portion of the facial contact portion. The patient interface also includes a positioning and stabilizing structure for maintaining a sealed contact between the sealing structure and the area surrounding the inlet of the patient airway, while maintaining a therapeutic pressure at the inlet of the patient airway; an inflation chamber pressurized during use at a pressure exceeding ambient pressure; and a gas flushing vent configured to allow exhaled CO2 from the patient to flow to the outside of the patient interface to minimize rebreathing of exhaled CO2.

[0107] In the example, (a) the sealing structure includes an unrestricted edge adjacent to the end of the first substantially cylindrical region, (b) the sealing structure includes an unrestricted edge surrounding the periphery of the inlet of the patient's airway except at the first substantially cylindrical region, (c) the portion of the face contact portion forms a convex surface adapted to contact the patient's face, (d) the first substantially cylindrical region is positioned to contact or adjacent to the patient's nasal alae, (e) the first substantially cylindrical region is positioned substantially parallel to the patient's nasal alae, (f) the patient interface further includes a second of the cylindrical region, (g) the cylindrical region includes a second substantially cylindrical region having a second uninterrupted circumference, wherein a portion of the second cylindrical region includes a second portion of the face contact portion, (h) wherein the first substantially cylindrical region includes a hollow interior adapted to communicate with a pressure fluid exceeding ambient pressure, (i) the first substantially cylindrical region includes two open ends, and / or (j) the first substantially cylindrical region is adapted to prevent the face contact portion from being ejected when the patient interface is pressurized internally and adjusted by the patient.

[0108] Another aspect of this technology is a patient interface for sealingly delivering an airflow to the inlet of a patient's airway (including at least the inlet of the patient's nostrils) under a continuous positive pressure relative to ambient atmospheric pressure. The patient interface is configured to maintain a therapeutic pressure within the range of approximately 3 cmH2O to approximately 40 cmH2O above ambient atmospheric pressure throughout the patient's respiratory cycle during sleep, in order to improve sleep-disordered breathing. The patient interface includes a sealing structure comprising a material folded over itself to form an uninterrupted tubular shape, wherein only a portion of the circumference of the tubular shape is configured to contact the patient's face; a positioning and stabilizing structure for maintaining a sealed contact between the sealing structure and an area surrounding the inlet of the patient's airway while maintaining the therapeutic pressure at the inlet of the patient's airway; an inflation chamber pressurized in use at a pressure exceeding ambient pressure; and a gas flushing vent configured to allow exhaled CO2 to flow to the outside of the patient interface to minimize rebreathing of exhaled CO2, wherein the outside of the tubular shape is adapted to be in fluid communication with a pressure exceeding ambient pressure.

[0109] In the example, (a) the uninterrupted tubular shape has an inner surface and an outer surface of the tube, the inner surface of the tube being adapted to be exposed to pressures exceeding ambient pressure during use, a first portion of the outer surface of the tube being adapted to be exposed to ambient pressure during use, and a second portion of the outer surface of the tube being adapted to be exposed to pressures exceeding ambient pressure during use; (b) the sealing structure further includes a surface that contacts the periphery of the patient's airway, and the portion of the uninterrupted tubular shape is part of the surface; (c) the uninterrupted tubular shape is open at at least one end. (d) The uninterrupted tubular shape is open at both ends; (e) The uninterrupted tubular shape is adapted to be next to the patient's nasal ala; (f) The uninterrupted tubular shape is adapted to contact the patient's nasal ala; (g) The material is folded to form a second uninterrupted tubular shape, wherein only a portion of the circumference of the second uninterrupted tubular shape is configured to contact the patient's face; (h) The uninterrupted tubular shape is adapted to be on the opposite side of the patient's nose; and / or (i) The uninterrupted tubular shape is adapted to prevent the material from being ejected when the patient interface is pressurized internally and adjusted by the patient.

[0110] Another aspect of this technology is a patient interface for sealingly delivering an airflow to the inlet of a patient's airway (including at least the inlet of the patient's nostrils) under a continuous positive pressure relative to ambient air pressure. The patient interface is configured to maintain a therapeutic pressure within a range of approximately 3 cmH2O to approximately 40 cmH2O above ambient air pressure throughout the patient's respiratory cycle during sleep, in order to improve sleep-disordered breathing. The patient interface includes a sealing structure to seal the interface against the patient's face. The sealing structure includes a first face contact portion having an unconnected edge at the inner boundary of the sealing structure, a second face contact portion being part of a tubular structure, and the first and second face contact portions each forming part of a continuous membrane configured to contact the patient's face around the periphery of the inlet of the patient's airway. The patient interface also includes a positioning and stabilizing structure for maintaining a sealed contact between the sealing structure and the area surrounding the inlet of the patient airway, while maintaining a therapeutic pressure at the inlet of the patient airway; an inflation chamber pressurized during use at a pressure exceeding ambient pressure; and a gas flushing vent configured to allow exhaled CO2 from the patient to flow to the outside of the patient interface to minimize rebreathing of exhaled CO2.

[0111] In the example, (a) the patient interface further includes a plurality of second facial contact portions, (b) the second facial contact portions are adapted to contact the patient’s face adjacent to or on the patient’s nasal ala, and / or (c) the tubular structure is adapted to prevent the continuous membrane from being ejected when the patient interface is internally pressurized and adjusted by the patient.

[0112] Another aspect of this technology is a patient interface for sealingly delivering an airflow to an inlet (including at least the inlet of the patient's nostrils) under a continuous positive pressure relative to ambient air pressure. The patient interface is configured to maintain a therapeutic pressure within a range of approximately 3 cmH2O to approximately 40 cmH2O above ambient air pressure throughout the patient's respiratory cycle during sleep, thereby improving sleep-disordered breathing. The patient interface includes a sealing structure to seal the interface against the patient's face. The sealing structure includes a sealing membrane and a sheet attached to the sealing membrane at a first end and to another structure at a second end to prevent the sealing membrane from being ejected outwards due to therapeutic pressure. The patient interface also includes a positioning and stabilizing structure for maintaining a sealed contact between the sealing structure and the area surrounding the inlet of the patient airway, while maintaining a therapeutic pressure at the inlet of the patient airway; an inflation chamber pressurized during use at a pressure exceeding ambient pressure; and a gas flushing vent configured to allow exhaled CO2 from the patient to flow to the outside of the patient interface to minimize rebreathing of exhaled CO2.

[0113] In the example, (a) the sealing membrane and the sheet form part of a tubular structure, and / or (b) the sealing membrane is adapted to make peripheral contact all around the entrance of the patient's airway, and the sheet is provided only for a portion of the periphery.

[0114] Another aspect of this technology is a patient interface for sealingly delivering an airflow to the inlet of a patient's airway (including at least the inlet of the patient's nostrils) under a continuous positive pressure relative to ambient air pressure. The patient interface is configured to maintain a therapeutic pressure within a range of approximately 3 cmH2O to approximately 40 cmH2O above ambient air pressure throughout the patient's respiratory cycle during sleep, in order to improve sleep-disordered breathing. The patient interface includes a sealing structure for sealing the patient interface against the patient's face. The sealing structure includes a sealing membrane adapted to contact the patient's face around the periphery of the inlet of the patient's airway; and a cylindrical region located below and attached to the sealing membrane. The patient interface also includes a positioning and stabilizing structure for maintaining a sealed contact between the sealing structure and the area surrounding the inlet of the patient airway, while maintaining a therapeutic pressure at the inlet of the patient airway; an inflation chamber pressurized during use at a pressure exceeding ambient pressure; and a gas flushing vent configured to allow exhaled CO2 from the patient to flow to the outside of the patient interface to minimize rebreathing of exhaled CO2.

[0115] In the example, (a) the cylindrical region is positioned adjacent to the patient's nasal ala, (b) the cylindrical region includes an axis substantially parallel to the patient's nasal ala, (c) the cylindrical region is adapted to prevent the sealing membrane from being ejected away from the inlet of the patient's airway when the inflation chamber is pressurized at a pressure exceeding ambient pressure, and / or (d) the sealing membrane includes an unconnected edge that surrounds the periphery of the inlet of the patient's airway.

[0116] Another aspect of this technology is a patient interface for sealingly delivering an airflow to the inlet of a patient's airway (including at least the inlet of the patient's nostrils) under a continuous positive pressure relative to ambient atmospheric pressure. The patient interface is configured to maintain a therapeutic pressure within a range of approximately 3 cmH2O to approximately 40 cmH2O above ambient atmospheric pressure throughout the patient's respiratory cycle during sleep, in order to improve sleep-disordered breathing. The patient interface includes a sealing structure to seal the interface against the patient's face. The sealing structure includes a sealing membrane comprising an inner surface and an outer surface, the outer surface being adapted to contact the patient's face around the periphery of the inlet of the patient's airway; and ribs located below and attached to the inner surface such that the ribs resist deformation of the sealing membrane when pressure is applied to the inner surface. The patient interface also includes a positioning and stabilizing structure for maintaining a sealed contact between the sealing structure and the area surrounding the inlet of the patient airway, while maintaining a therapeutic pressure at the inlet of the patient airway; an inflation chamber pressurized during use at a pressure exceeding ambient pressure; and a gas flushing vent configured to allow exhaled CO2 from the patient to flow to the outside of the patient interface to minimize rebreathing of exhaled CO2.

[0117] In the example, (a) the outer surface includes a convex portion, (b) the inner surface has a concave portion, (c) the concave portion and the convex portion are respectively positioned directly opposite each other on the outer and inner surfaces, and the rib is attached to the inner surface at the concave portion, (d) the rib is easily crushed by a force applied to the patient interface to hold the patient interface to the patient, (e) the patient interface also includes a plurality of ribs, (f) the ribs are adapted to be adjacent to the patient's nose, (g) the ribs are adapted to prevent the sealing film from being ejected when the patient interface is pressurized internally and adjusted by the patient, and / or (h) the ribs are substantially orthogonal to the inner surface.

[0118] Another aspect of this technology is a patient interface that is cast or otherwise constructed using a peripheral shape that complements the shape of the intended wearer.

[0119] One aspect of this technology is a method for manufacturing equipment.

[0120] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for use by an untrained individual, by an individual with limited sensitivity or vision, or by an individual with limited experience in using this type of medical device.

[0121] One aspect of this technology is a portable RPT device that can be carried by an individual (e.g., around a personal home).

[0122] One aspect of this technology is a patient interface that can be cleaned at home (e.g., in soapy water) without requiring specialized cleaning equipment. Another aspect of this technology is a humidifier tank that can be cleaned at home (e.g., in soapy water) without requiring specialized cleaning equipment.

[0123] The methods, systems, apparatuses, and devices described herein can provide improved functionality in processors, such as processors for dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, apparatuses, and devices can provide improvements in the field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep apnea.

[0124] Of course, the parts of each aspect can form sub-aspects of the present invention. In addition, the sub-aspects and / or aspects of the aspects can be combined in any way and also constitute other aspects or sub-aspects of the present invention.

[0125] Other features of the invention will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims. Attached Figure Description

[0126] This technology is illustrated in the accompanying drawings by way of example rather than limitation, wherein the same reference numerals denote similar elements, including:

[0127] 4.1 Processing System

[0128] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient is sleeping in a supine position.

[0129] Figure 1BA system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0130] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a side-lying sleeping position.

[0131] 4.2 Respiratory System and Facial Anatomy

[0132] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0133] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, external nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, pharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0134] Figure 2C It is a frontal view of the face with several marked surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0135] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, lower nasal septum, upper lip, lower lip, supramental point, bridge of the nose, apex of the nostrils, lower base of the ear, and upper base of the ear. The vertical and anteroposterior directions are also marked.

[0136] Figure 2E This is another side view of the head. The approximate locations of the Frankfurt plane and the nasolabial angle are indicated. The coronal plane is also shown.

[0137] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial groove, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and sagittal plane.

[0138] Figure 2G A side view showing the surface features of the nose.

[0139] Figure 2HThe subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0140] Figure 2I The diagram shows the medial anatomy of the nose from the sagittal plane, approximately a few millimeters in diameter, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0141] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also labeled.

[0142] Figure 2K A side view of the skull showing the surface contours of the head and several muscles is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0143] Figure 2L The frontal lateral view of the nose is shown.

[0144] 4.3 Patient Interface

[0145] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0146] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0147] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0148] Figure 3D A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point is zero.

[0149] Figure 3E A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0150] Figure 3FA schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0151] Figure 3G A cushion for a face mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome-shaped and saddle-shaped areas are indicated.

[0152] Figure 3H The pad used for the face mask is shown. The outer surface of the pad is indicated. The edge of the surface is indicated. The path on the surface between points A and B is indicated. The straight-line distance between points A and B is indicated. Two saddle-shaped areas and one dome-shaped area are indicated.

[0153] Figure 3I The surface of the structure is shown, in which a one-dimensional hole is present. The planar curve shown forms the boundary of the one-dimensional hole.

[0154] Figure 3J It shows the way Figure 3I The cross-section of the structure. The surface constraint shown. Figure 3I Two-dimensional holes in the structure.

[0155] Figure 3K Show Figure 3I A perspective view of the structure, which includes two-dimensional holes and one-dimensional holes. A restraint is also shown. Figure 3I The surface of a two-dimensional hole in a structure.

[0156] Figure 3L A face mask with an inflatable airbag as a cushion is shown.

[0157] Figure 3M It shows the way Figure 3L The cross-section of the mask is shown, and the inner surface of the airbag is also shown. The inner surface restricts two-dimensional holes in the mask.

[0158] Figure 3N It shows the way Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0159] Figure 3O The left-hand rule is shown.

[0160] Figure 3P The right-hand rule is shown.

[0161] Figure 3Q The left ear is shown, including the left ear spiral.

[0162] Figure 3R The right ear is shown, including the right ear spiral.

[0163] Figure 3S The right-hand spiral is shown.

[0164] Figure 3T A view of the face mask is shown, which includes torsion marks of spatial curves defined by the edges of sealing membranes in different areas of the face mask.

[0165] 4.4RPT device

[0166] Figure 3U An RPT device of one form according to the present technology is shown.

[0167] 4.5 Humidifier

[0168] Figure 3V An isometric view of one form of humidifier according to the present technology is shown.

[0169] Figure 3W An isometric view of one form of humidifier according to the present technology is shown, illustrating the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0170] 4.6 Sealing structure and patient interface

[0171] Figure 4 A perspective view depicting the sealing structure.

[0172] Figure 5 A perspective view depicting the sealing structure.

[0173] Figure 5A A perspective view depicting the sealing structure, wherein the ring includes a closed end.

[0174] Figure 6 Draw a plan view of the sealing structure.

[0175] Figure 7 Depicting along Figure 6 The cross-sectional view taken by line 7-7.

[0176] Figure 7A Describing and Figure 7 The same cross-sectional view, but the angle of the structure is changed.

[0177] Figure 7B-7I Depicting Figure 7 Mechanical attachment at the cross-sectional view.

[0178] Figures 8A to 8G Depicting along Figure 6 A cross-sectional view taken from the corresponding line.

[0179] Figure 9 Draw a plan view of the sealing structure.

[0180] Figure 10 A perspective view depicting the sealing structure.

[0181] Figure 11 A simplified representation depicting tubular structures and sheets.

[0182] Figure 12 A simplified representation of tubular structures and sheets attached to a sealing structure.

[0183] Figure 13 A simplified representation of the compliance of the sealing structure.

[0184] Figure 14 A perspective view depicting the sealing structure.

[0185] Figure 15 A cross-sectional view depicting the ribs forming the sealing structure is shown.

[0186] Figure 16 A cross-sectional view depicting a rib under compression.

[0187] Figure 17 A cross-sectional view depicting a rib under tension.

[0188] Figure 18 and 19 The cross-section of the sealing structure is shown.

[0189] Figure 20 Describe the different regions of the seal-forming structure.

[0190] Figure 21 Describe the sealing structure attached to the mask housing.

[0191] Figure 22 Depict an exploded view of the sealing structure and the two clips.

[0192] Figure 23 Depict the views of the mat and clips.

[0193] Figure 23A Draw the section intercepted along line 23A-23A Figure 23 A cross-sectional view.

[0194] Figure 24 A perspective view depicting the sealing structure.

[0195] Figure 25A Depicting Figure 24 Front view of the sealing structure.

[0196] Figure 25B-25G Depicting along Figure 25A Different cross sections are cut from the corresponding lines in the diagram.

[0197] Figure 26 Depicting Figure 24 Rear view of the sealing structure.

[0198] Figure 27 Depicting Figure 24 The sealing forms different areas of the structure.

[0199] Figure 27 Describe the different regions of the seal-forming structure.

[0200] Figure 28A This is a top perspective view of a sealing formation structure for a comprehensive patient interface, according to an example of this technology.

[0201] Figure 28B This is a front view of a sealing formation structure for a comprehensive patient interface, according to an example of this technology.

[0202] Figure 28C This is a rear view of a sealing formation structure for a comprehensive patient interface, according to an example of this technology.

[0203] Figure 28D This is a top view of a sealing formation structure for a comprehensive patient interface, according to an example of the present technology.

[0204] Figure 28E This is a bottom view of a sealing formation structure for a comprehensive patient interface, according to an example of this technology.

[0205] Figure 28F This is a side view of a sealing formation structure for a comprehensive patient interface, according to an example of this technology.

[0206] Figure 28G This is a bottom perspective view of a sealing formation structure for a comprehensive patient interface, according to an example of this technology.

[0207] Figure 28H This is another top perspective view of a sealing formation structure for a comprehensive patient interface, according to an example of this technology.

[0208] Figure 28I This is another bottom view of a sealing formation structure for a comprehensive patient interface, according to an example of this technology.

[0209] Figure 28J This is an example of a sealing formation structure for a comprehensive patient interface according to the present technology. Figure 28B A cross-sectional view taken from line 28J-28J.

[0210] Figure 28K This is an example of a sealing formation structure for a comprehensive patient interface according to the present technology. Figure 28BA cross-sectional view taken from line 28K-28K.

[0211] Figure 28L This is an example of a sealing formation structure for a comprehensive patient interface according to the present technology. Figure 28B A cross-sectional view taken from line 28L-28L.

[0212] Figure 28M yes Figure 28L The diagram shows a perspective view of the sealing structure for a comprehensive patient interface.

[0213] Figure 29A This is a top perspective view of a component of a sealing formation structure and an inflation chamber for a comprehensive patient interface, according to an example of the present technology.

[0214] Figure 29B This is a front perspective view of a sealing formation structure and an inflation chamber assembly for a comprehensive patient interface, according to an example of the present technology.

[0215] Figure 29C This is an example of a component for a comprehensive patient interface sealing structure and an inflation chamber, based on the present technology. Figure 29B A cross-sectional view taken from line 29C-29C.

[0216] Figure 29D This is an example of a component for a comprehensive patient interface sealing structure and an inflation chamber, based on the present technology. Figure 29B A cross-sectional view taken from line 29D-29D.

[0217] Figure 29E This is an example of a component for a comprehensive patient interface sealing structure and an inflation chamber, based on the present technology. Figure 29B A cross-sectional view taken from line 29E-29E.

[0218] Figure 30A This is a top perspective view of the full patient interface based on an example of this technology.

[0219] Figure 30B This is a top perspective view of the full patient interface based on an example of this technology.

[0220] Figure 31A This is a top perspective view of a sealing formation structure for a nasal patient interface according to an example of the present technology.

[0221] Figure 31B This is a front view of a sealing structure for a nasal patient interface, according to an example of the present technology.

[0222] Figure 31CThis is a rear view of a sealing structure for a nasal patient interface, according to an example of the present technology.

[0223] Figure 31D This is a top view of a sealing formation structure for a nasal patient interface according to an example of the present technology.

[0224] Figure 31E This is a bottom view of a sealing formation structure for a nasal patient interface according to an example of this technology.

[0225] Figure 31F This is a side view of a sealing structure for a nasal patient interface, according to an example of the present technology.

[0226] Figure 31G This is a bottom perspective view of a sealing formation structure for a nasal patient interface according to an example of the present technology.

[0227] Figure 31H This is another top perspective view of a sealing formation structure for a nasal patient interface, according to an example of the present technology.

[0228] Figure 31I This is another bottom view of a sealing formation structure for a nasal patient interface, according to an example of the present technology.

[0229] Figure 31J This is an example of a sealing structure for a nasal patient interface according to the present technology. Figure 31B The cross-sectional view taken from line 31J-31J.

[0230] Figure 31K This is an example of a sealing structure for a nasal patient interface according to the present technology. Figure 31B A cross-sectional view taken from line 31K-31K.

[0231] Figure 31L This is an example of a sealing structure for a nasal patient interface according to the present technology. Figure 31B A cross-sectional view taken from line 31L-31L.

[0232] Figure 31M yes Figure 31L The diagram shows a perspective view of the sealing structure for a comprehensive patient interface.

[0233] Figure 32A This is a top perspective view of a sealing formation structure and an air chamber assembly for a nasal patient interface, according to an example of the present technology.

[0234] Figure 32B This is a front perspective view of a sealing formation structure and an air chamber assembly for a nasal patient interface, according to an example of the present technology.

[0235] Figure 32C This is an example of a sealing structure and an air chamber assembly for a nasal patient interface according to an embodiment of the present technology. Figure 32B A cross-sectional view taken from line 32C-32C.

[0236] Figure 32D This is an example of a sealing structure and an air chamber assembly for a nasal patient interface according to an embodiment of the present technology. Figure 32B A cross-sectional view taken from line 32D-32D.

[0237] Figure 32E This is an example of a sealing structure and an air chamber assembly for a nasal patient interface according to an embodiment of the present technology. Figure 32B A cross-sectional view taken from line 32E-32E.

[0238] Figure 32F This is a cross-sectional view of a sealing structure and an air chamber assembly for a nasal patient interface, according to an example of the present technology.

[0239] Figure 33A This is a top perspective view of a nasal patient interface according to an example of this technology.

[0240] Figure 33B This is a top perspective view of a nasal patient interface according to an example of this technology.

[0241] Figure 34A This is a detailed side view of a sealing structure for a comprehensive patient interface, based on related technologies for applying therapeutic pressure.

[0242] Figure 34B This is a detailed side view of a sealing structure for a comprehensive patient interface, based on another related technology that applies therapeutic pressure. Detailed Implementation

[0243] Before describing the invention in further detail, it should be understood that the invention is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein and is not intended to be limiting.

[0244] The following description is provided in relation to various instances that may share one or more common features and / or characteristics. It should be understood that one or more features of any instance may be combined with one or more features of another instance or other instances. In addition, in any instance, any single feature or combination of features may form further instances.

[0245] 5.1 Treatment

[0246] In one form, the technology includes a method for treating respiratory distress, the method comprising the step of applying positive pressure to the inlet of the airway of a patient 1000.

[0247] In some embodiments of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0248] In some embodiments of this technology, mouth breathing is defined, restricted, or prevented.

[0249] 5.2 Treatment System

[0250] In one form, the technology includes an instrument or device for treating respiratory disorders. The instrument or device may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 leading to a patient interface 3000.

[0251] 5.3 Patient Interface

[0252] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an exhaust port 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is configured to surround an inlet to the patient's airway to facilitate a positive pressure air supply to the airway.

[0253] The inventors have discovered that if the patient interface 3000 cannot deliver even the minimum level of positive pressure comfortably into the airway, treatment may be ineffective.

[0254] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to the environment.

[0255] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to the environment.

[0256] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to the environment.

[0257] 5.3.1 Sealing Formation Structure

[0258] In one form of this technology, the sealing forming structure 3100 provides a sealing forming surface and may additionally provide a cushioning function.

[0259] The sealing structure 3100 according to this technology can be constructed from a soft, flexible and elastic material such as silicone.

[0260] In one embodiment, the non-invasive patient interface 3000 includes a sealing forming portion that, during use, forms a seal on the upper lip region (i.e., the upper lip) of the patient's face.

[0261] In one embodiment, the non-invasive patient interface 3000 includes a sealing forming portion that forms a seal on the chin region of the patient's face during use.

[0262] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each sealing formation structure being configured to correspond to a different size and / or shape range. For example, the system may include one form of sealing formation structure 3100 suitable for a large-sized head rather than a small-sized head; and another form of sealing formation structure suitable for a small-sized head rather than a large-sized head.

[0263] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material, such as silicone rubber.

[0264] Figure 4 A perspective view shows a seal-forming structure 3100 separated from the rest of the patient interface 3000. The seal-forming structure includes a sealing surface 3105 configured to form a seal around the periphery of the patient's airway. The seal may be formed around the patient's nose or around the patient's nose and mouth.

[0265] The sealing structure 3100 includes a strap, connecting portion, or loop 3110 that folds the sealing structure 3100 inward from its outer periphery 3115 (e.g., towards the patient's face in use). The outer periphery 3115 can generally be defined as a wall that supports the sealing surface 3105 and / or is continuously formed with said sealing surface. In this way, the strap 3110 can be formed into a substantially tubular structure 3120 such that the strap 3110 forms a continuous structure (e.g., a continuous circumference) with the sealing surface 3105 and the outer periphery 3115. Therefore, the strap 3110 can include a portion of the sealing surface 3105, a portion of the outer periphery 3115, and a portion that is neither a portion of the sealing surface 3105 nor the outer periphery 3115. The portion that is neither a portion of the sealing surface 3105 nor the outer periphery 3115 can be in the form of a sheet or plate attached or continuous at one end to said sealing surface and at the other end to the outer periphery 3115. The frenulum 3110 can be positioned beside the patient's nose, such as along the nasal ala, above or between the nasal bones. Two frenulum 3110s can be provided on opposite sides of the patient's nose. The frenulum 3110 can be internally opened, including one or both ends, such that the frenulum 3110 is internally pressurized (e.g., in fluid communication) with the patient's treatment pressure during use.

[0266] In one form of this technology, the tether 3110 may extend only partially around the periphery of the seal forming structure 3100.

[0267] In one embodiment, the tether 3110 and the sealing structure 3100 do not form a closed pressurized structure (e.g., an airbag) such that the space between the tether 3110 and the sealing structure 3100 opens into the pressure opening in the interior of the patient interface 3000.

[0268] In one form, the sealing structure 3100 has an edge, and the strap 3110 holds the edge to prevent ejection at the edge.

[0269] The area of ​​the sealing surface 3105, excluding the frenulum 3110, may include a sealing tab 3125 that protrudes inward toward the inner periphery of the sealing structure 3100. The sealing tab 3125 may have unconnected edges at or near a radially inner portion of the sealing surface 3105. The sealing tab 3125 may include a portion 3125a configured to form a seal against the sides of the nose above the nasal bone of a patient. The sealing tab 3125 may be configured to avoid sealing against the alar, for example, by being sufficiently far outwardly spaced relative to the alar to avoid or minimize contact with the alar.

[0270] Figure 5 Show Figure 4The image shows a substantially opposing perspective view of the sealing structure 3100. The substantially tubular structure 3120 can be more easily seen from the view. Figure 5A The figure shows a tether 3110 with a closed end 3111. The figure also shows a seal forming structure 3100 without a lower gasket, and therefore the seal forming structure 3100 can be referred to as a single-layer gasket.

[0271] Figure 6 A plan view of the sealing structure 3100 is shown, and it is used as a... Figure 7 The basis for the two cross-sectional views shown in Figure 8.

[0272] Figure 7 This is a cross-section taken through the tie 3110. The substantially tubular structure 3120 can be more easily identified from this view. The tie 3110 includes a relatively thick portion 3130 and a relatively thin portion 3135. The thickness of the relatively thick portion 3130 may be between 1 mm and 2 mm, or between 1.3 mm and 1.7 mm, or about 1.5 mm. The thickness of the relatively thin portion 3135 may be between 0.2 mm and 0.8 mm, or between 0.4 mm and 0.6 mm, or about 0.5 mm. Alternatively, the thickness of the relatively thick portion 3130 may be about 2.5 to 5 times that of the relatively thin portion 3135, or about 2.8 to 3.3 times that of the relatively thin portion 3135, or three times that of the relatively thin portion 3135. The relatively thick portion 3130 is shown as including an outer periphery 3115 and a majority of the sealing surface 3105 at the tie 3110. The relatively thin portion 3135 folds the sealing structure inward and connects back to the sealing forming structure 3100 at connection point 3165, which is located at or near the hinge structure 3140. The hinge structure 3140 is shown as a localized, relatively thin strip or line that can provide preferential bending or flexing at a predetermined location, which can provide flexibility to the sealing forming structure 3100 to conform to the patient's face. The relatively thick portion 3130 can provide sufficient elasticity to provide an effective seal against the patient's face. The relatively thin portion 3135 can provide resistance to ejection of the sealing surface 3105 under pressure without causing the sealing surface 3105 to have too much stiffness and be too hard to form an effective seal. Alternatively, the thicknesses of the relatively thick portion 3130 and the relatively thin portion 3135 can be... Figure 7 The opposite is shown in the diagram. Alternatively, a relatively thin portion 3135 may be extended to surround the sealing surface 3105. Any combination of thicknesses can be used to achieve the desired combination of sealing capability and anti-ejection properties.

[0273] The connection point 3165 can be determined based on the required force applied by the tie 3110 or the required elasticity of the tie. For example, as Figure 7AAs shown, the angle 3170 formed by the relatively thin portion 3135 is variable. When the angle 3170 changes, the tension in the relatively thin portion 3135 also changes. Therefore, the angle 3170 can be optimized to prevent ejection and / or for patient comfort.

[0274] Angle 3170 can be predetermined in several ways. For example, if the sealing structure 3100 is a single molded part, the mold used to form the sealing structure 3100 will determine angle 3170. Different angles can be achieved using different molds. Alternatively, the relatively thin portion 3135 can be manufactured in an unattached state so that the connection point 3165 is formed in a later assembly step. The connection point 3165 can be a mechanical connection or an adhesive bond. If an adhesive bond is used, the connection point 3165 can vary continuously within an acceptable range of attachment. Alternatively, a mechanical attachment can be used. Figure 7B-7I An exemplary mechanical attachment is shown. Figures 7B-7E In this context, connection point 3165 is keyed so that different angles can be achieved in a single connection point 3165. Figure 7B and 7C The first connection orientation of the keyed connection is shown, and Figure 7D and Figure 7E This illustrates a second connection orientation for keyed connections. Figure 7F-7I In this context, multiple discrete connection points 3165 are provided. The selected connection point 3165 will determine the angle 3170. Figure 7F and 7G The first discrete connection of discrete connection points is shown, and Figure 7H and Figure 7I The second discrete connection is shown, where the discrete connection points are discrete. Figure 7B-7I The specific geometries shown are merely illustrative and should not be considered limiting. Other keyed or discrete connection geometries may be used.

[0275] If possible Figure 7 It is understood that the frenulum 3110 can be positioned to contact the sidewalls of the nose, including the alar. The frenulum 3110 can also provide a continuous surface to maintain lateral contact with the patient's nose above the nasal bone.

[0276] Figure 8A Showing through Figure 6 A cross-section taken from a vertical plane. For example, it can be... Figure 8AAs is most readily apparent, the frenulum 3110 is attached at the attachment portion 3145 to the wall forming the outer periphery 3115. As shown, the attachment portion 3145 is a continuous portion of the frenulum 3110, which can be achieved by molding the sealing forming structure 3100 into a single piece. However, the attachment portion 3145 can also be achieved in any other convenient manner, for example, by securing the free end of the frenulum 3110 using some form of mechanical or chemical fastening (such as an adhesive). The entire length of the attachment portion 3145, together with the frenulum 3110, can be selected such that when pressure (e.g., therapeutic pressure) is applied to the inner surface of the frenulum 3110 and the sealing forming structure 3100 is pulled away from the patient's face and / or when insufficient headband tension is present, sufficient tension is provided to the frenulum 3110 to counteract the ejection of the sealing surface 3105.

[0277] Some or all of the sealing surface 3105 may be areas of (relative) reduced friction. This can be achieved by providing a so-called abrasive surface. In areas of reduced friction, the sealing surface may adhere less to the patient's face than in areas without reduced friction. Areas of reduced friction may be provided as part of the frenulum 3110 to allow the sides of the patient's nose to slide freely along the sealing surface 3105 and / or the frenulum 3110.

[0278] Figure 8A-8G It also shows Figure 6 The various cross sections, wherein the intersection of the cross sections illustrates that the sealing forming structure 3100 includes various saddles and domes. For simplicity, the intersection of the various cross sections is referred to herein by their acronym combination. For example, the intersection of the cross section taken along line 8A-8A and the cross section taken along line 8B-8B is referred to as intersection AB.

[0279] Cross AB is obtained at a first dome region configured to contact the patient's nasal ridge below the point of the patient's nasal bridge. Cross AC is obtained at a first saddle-shaped region configured to contact the patient's nasal ridge at a location below the point of cross AB. Cross AD is obtained at a second saddle-shaped region configured to contact the patient's lower lip and / or supramental point. Cross EF is obtained at a second dome-shaped region configured to contact the patient's mouth near the corner of the mouth, outside the patient's mouth but close to the patient's mouth. Cross EG is obtained at a third saddle-shaped region configured to contact the patient's cheek adjacent to the patient's nasal ala. Relative to each other, the first dome region has a relatively large curvature along both cross sections, and the second dome region has a relatively small curvature along both cross sections. The first saddle-shaped region has a relatively large curvature along both cross sections, and the third saddle-shaped region has a relatively small curvature along line 8E-8E and a relatively large curvature along line 8G-8G. The second saddle-shaped region has a curvature along line 8D-8D that is between the first and third saddle-shaped regions, and line 8A-8A is similar to the curvature along line 8G-8G.

[0280] Figure 9 This illustrates another aspect of the technology. For example, instead of the tether 3110 which is continuous with the sealing surface 3105, Figure 9 The tie 3110 is shown below the sealing surface 3105. The tie 3110 is mainly shown as a dashed line. This construction can be achieved by attaching or forming a strip or tube of material below the sealing surface 3105. The tie 3110 below can... Figure 10 It's easier to see in the middle.

[0281] Figure 9 Also shown is a sheet 3150 that can extend from the sealing surface 3105 generally near the frenulum 3110 and / or the patient's nose. This sheet 3150 can aid in sealing and / or comfort associated with the patient's nose, which is located above the maxilla and adjacent to the inner canthus. This area of ​​the patient's face may be difficult to seal with some known devices. Alternatively, the sheet 3150 can extend from the frenulum 3110, which can fix the position of the sheet 3150 relative to the frenulum 3110. Figure 11 A simplified representation of the ties 3110, which is a generally tubular structure 3120, is shown, from which the sheet 3150 extends.

[0282] Figure 12 The attachment to the sealing structure 3100 is shown. Figure 11 The simplified representation of the essentially tubular structure 3120 shown is based on... Figure 12 Basically, the tubular structure 3120 can be manufactured separately and fastened to form a sealed structure 3100.

[0283] Figure 13This illustrates how the essentially tubular structure 3120 provides compliance to allow the sealing formation structure 3100 to fit the patient's face. Even in compliance, this technology prevents ejection.

[0284] Ejection can be understood as deformation of the seal-forming structure 3100, caused at least in part by a pressure difference resulting from pressure applied during treatment, causing the sealing surface 3105 to displace from its sealing contact with the patient's face. For example, the patient may pull the patient interface 3000 away from the face during treatment (i.e., while pressure is applied), and the force of the treatment pressure can cause deformation of the seal-forming structure 3100 as the patient interface 3000 is displaced from the patient's face. When the patient interface 3000 is then reapplied to the patient's face by the patient, the sealing surface 3105 of the seal-forming structure 3100 may be displaced due to deformation, resulting in an invalid seal and leakage of pressurized gas from the seal-forming structure 3100. During this repositioning of the seal-forming structure 3100, the internal pressurization of the inflation chamber 3200 may be disturbed, resulting in a pressure gradient near the sealing strip 3125. This pressure gradient can provide force, which may ultimately lead to ejection of the sealing strip. Displacement of the sealing disc during ejection can move it to a position that interrupts the seal by creating a leakage path when the sealing structure is repositioned onto the face. When ejection of the seal-forming structure 3100 occurs in an area close to the patient's eyes (e.g., when the sealing surface 3105 near the frontal process of the maxilla is displaced), pressurized gas may flow toward the patient, which can be particularly disruptive and troublesome. Therefore, it is advantageous to reduce ejection.

[0285] The ejection deformation can cause the sealing structure 3100 to be positioned in an outward direction, such as away from the patient's face. In fact, under extreme conditions of high internal pressure, the ejection may involve the sealing structure 3100 folding backward on itself.

[0286] The contours of the nasal side (including the area above the nasal bone, the frontal process near the maxilla, and the lateral cartilages) can be highly variable between users. Furthermore, to seal this area, the inner edge of the sealing strip 3125 can be bent inward (e.g., into the inflation chamber and perpendicular to the Frankfurt horizontal) and deformed to conform to the contours of the nasal side. Therefore, this area may be particularly prone to seal interruption after dispensing. That is, if the sealing strip 3125 shifts outward during dispensing (e.g., away from the patient's face), it is generally difficult to return the sealing strip to the sealed position due to resistance from the forces of the pressurized gas.

[0287] However, ejection can also occur in other areas, such as the cheek region or the upper or lower lip region where seal interruption is less likely, but these areas have a generally flat profile that runs substantially along the coronal plane. During ejection, the seal may not move significantly from the position required for sealing along this plane, and the sealing force provided by the headgear vector is usually sufficient to reposition the seal to the orientation required to regain a seal.

[0288] The sealing strip provides a larger surface area on the sides of the nose area and the rear surface below the bottom corner of the seal, making it easier to shift under internal pressure.

[0289] While double-walled seal-forming structures 3100 may be prone to ejection, single-walled seal-forming structures 3100 (such as those disclosed in embodiments of this technology) may be particularly prone to ejection.

[0290] The absence of an additional base pad structure to support the outer seal wall can be understood as allowing the outer seal wall to deform and deflect more easily. Furthermore, when repositioning the patient interface 3000, the base pad in a double-wall pad can help reposition the outer seal wall to the patient's face, but this assistance may not be available in a single-wall pad.

[0291] Figure 34A and 34B An example of a patient interface 3000 related to the technology that has already been used to induce an ejection is shown. Figure 34A In this process, deformation of the sealing structure 3100 can be observed, such that the sealing surface 3105 at the ejection region BR1 is displaced from the patient's nose. Furthermore, deformation of the sealing structure 3100 can be observed, such that the sealing surface 3105 at another ejection region BR2 is displaced from the side of the patient's nose (e.g., near the frontal process of the maxilla) (see [link to other document]). Figure 2H Similarly, Figure 34B Describe the displacement of the sealing surface 3105 of the sealing structure 3200 at the ejection area BR2 on the side of the patient's nose (e.g., near the frontal process of the maxilla).

[0292] In the two examples of ejection described above, the patient interface 3000 is a full-body patient interface that seals around the nose and mouth. Such patient interfaces may be particularly prone to ejection because the relatively elongated lateral portions may have less support in the central region, and ejection can occur in these areas. Furthermore, the force vectors of the positioning and stabilizing structures 3300 may generally be parallel to the Frankfurt horizontal plane or the sagittal plane. Therefore, these force vectors may not be directed to exert force on the sealing-forming structure 3100 of the frontal process of the maxilla, which is generally perpendicular to the inward direction, in order to resist deformation of the sealing-forming structure 3100 that leads to ejection. In other words, the force of the therapeutic pressure causing deformation of the sealing-forming structure 3100 may have a magnitude and direction that are not sufficiently opposite to the force vectors from the positioning and stabilizing structures 3100. While ejection may be particularly relevant for full-body patient interfaces, it should also be understood that nasal patient interfaces can also be prone to ejection based on the same principles. Therefore, the frenulum 3110 disclosed herein can be incorporated into both nasal and full-body patient interfaces to resist ejection.

[0293] Furthermore, there are relevant distinctions regarding the context of sealing surface 3105. Sealing surface 3105 can be understood broadly to refer to the area on the sealing forming structure 3100 where a seal may be intended to occur. Because the anthropometry of each patient's head and face is different, the sealing forming structure 3100 can be shaped and sized to provide a comfortable fit and effective seal across a range of patients. Therefore, it should be understood that a seal may be intended to occur across various areas of the sealing forming structure 3100, and sealing surface 3105 can broadly refer to such areas. Once the sealing forming structure 3100 is actually applied to a particular patient in use, the seal may be formed at a specific portion of the wider area where a seal is intended to occur. The area where a seal actually occurs in use can also be understood as sealing surface 3105. The specific meaning of sealing surface 3105 can be understood as being limited by the specific context of the use of terminology as described above.

[0294] Referring back to the discussion of ejection above, ejection can be understood as a situation where the sealing surface 3105, intended to create a seal, shifts away from the patient's face. When such displacement occurs, at least an effective seal may be prevented, and more seriously, sealing contact may not occur at all.

[0295] Figure 14Another aspect of the present technology that can prevent the seal-forming structure 3100 from ejecting is shown. Here, two ribs 3155 are shown, but any number of ribs may be provided. For example, a single rib or three or more ribs may be provided. Similar to the frenulum 3110, each rib 3155 tends to prevent the seal-forming structure 3100 (e.g., sealing surface 3105) from ejecting. The ribs may have the same thickness or different thicknesses. For example, one or both ribs 3155 may be about 1 mm thick, and one or both ribs 3155 may be about 0.5 mm thick. Alternatively, the ribs may have variable thicknesses. When the ribs 3155 are attached, the sealing surface 3105 may be convex, and the opposite side may be concave when the ribs 3155 are attached. Thus, the convex and concave surfaces define the thickness of the material in the area. The ribs 3155 may be positioned adjacent to the patient's nose.

[0296] Figure 15 A cross-section of the seal-forming structure 3100, taken from a plane perpendicular to rib 3155, is shown. Rib 3155 can be relatively compliant under compression or easily crushed under sealing loads, thereby allowing the seal-forming structure 3100 and / or sealing surface 3105 to be adapted to the patient's face. This is in Figure 16 As shown in the image. However, as... Figure 17 As shown, rib 3155 can provide relatively large tensile resistance, which may occur inside the seal-forming structure 3100, for example, when pressure is applied inside the surface 3105a opposite the sealing surface 3105. In this way, rib 3155 may tend to resist ejection of the seal-forming structure 3100; for example, rib 3155 can become a tension member. For example, rib 3155 tends to hold the seal-forming structure 3100 in an ejected state or shape.

[0297] Figure 18 and 19 An extension strip 3160 is shown that allows for greater distances D1 and D2 to accommodate facial variations, where the distance between the sides of the nose and the sealing strip varies. The sealing surface 3105 of the extension strip 3160 also provides an effective seal against the cheeks. Arrows indicate areas of potential contact with the patient. This type of construction typically uses a membrane seal on conventional silicone masks and is prone to spraying when the mask is repositioned. Straps 3110 or ribs 3155 can prevent spraying while still allowing for an effective seal despite variations in distance due to facial differences.

[0298] Figure 20 Showing something similar Figure 6 The view, except that a pattern is included on the sealing structure 3100. The pattern represents a region 3175 of similar thickness of the sealing structure 3100.

[0299] Zone 3175A can be a relatively thin zone, for example, about 0.3 mm. This zone may be thin to achieve comfort and compliance at the bridge of the nose.

[0300] Region 3175B can be a very thin region, for example, about 0.2 mm. This reduction in thickness relative to region 3175A can significantly reduce tension, which may result in minimal to almost no facial markings at the bridge of the nose. The bridge of the nose is quite bony for most patients and can therefore be easily marked and / or uncomfortable.

[0301] Region 3175C can be a semi-thin region, for example, about 1 mm. This region can be semi-thin to prevent pinching pain on the side of the nose.

[0302] Region 3175D can be a semi-thick region, for example, about 1.5 mm. This region may be sealed on the cheek next to the nose. This region of the face usually has more fat than the sides of the nose or bridge of the nose, which allows for the application of a relatively large sealing force without discomfort. A semi-thick region can also provide more structural rigidity than a thinner region.

[0303] Region 3175E can be a thicker region, for example, about 2.0 mm. This thicker peripheral region can provide a more rigid outer wall to support the internal portion of the pad. Region 3175E can function like the base pad in existing dual-layer pad designs; for example, region 3175E can support a portion of the seal-forming structure 3100 that contacts the patient's face. For example, region 3175E can provide support for regions 3175D and / or 3175F (discussed below). The overall cross-sectional shape of the pad can be curved to provide an air (pressure) auxiliary spring for sealing and compliance. This construction can provide advantages over previously thicker base pads in existing masks because the disclosed construction with this thicker region can still be compressed to provide a degree of compliance to support the formation of a seal. This may increase the total range of distances the pad can be compressed compared to previous dual-layer designs.

[0304] Region 3175F can be a thin film region, for example, about 0.3-0.5 mm. The portion sealing below the lower lip can be thin, for example, about 0.3 mm, to allow for mandibular movement. This thin film region can also provide a lighter load on the patient's gums for comfort. The portion of region 3175F adjacent to region 3175D is the location where the frenulum 3110 is positioned. The portion of region 3175F can be thin, for example, about 0.5 mm, to allow for compression of the frenulum 3110. The portion of region 3175F configured to contact the side of the patient's mouth can be about 0.5 mm and can function as a sealing film layer of a double-layer pad, maintaining a seal against microscopic changes in facial contours and movement during sleep.

[0305] Although different lines are shown between regions 3175, the regions can transition smoothly from region to region in terms of relative thickness, and the boundaries between regions are approximate. This can be advantageous because it limits the ability to distinguish thick and thin regions by the naked eye, and it can also be more aesthetically pleasing. However, a more pronounced transition could also be provided.

[0306] International Patent Application Publication No. WO 2006 / 074513 discloses a mat, which is incorporated herein by reference in its entirety. In this type of mat, a thicker base pad and a thinner membrane layer are disclosed. The thinner membrane provides a light seal on the face under pressure (i.e., expansion), while the base pad provides structural support to maintain the seal. A curved cross-section provides a pressure-assisted spring for supporting the seal under headband tension.

[0307] In contrast, the seal-forming structure 3100 having one or more of the aforementioned regions 3175 can be a single layer, combining the functions of the membrane and the base pad of WO 2006 / 074513. The maximum thickness of the cross-section of region 3175 (e.g., region 3175E) can be thinner than the maximum thickness of the base pad of WO 2006 / 074513. However, combining the base pad and membrane into a single layer allows sufficient structural stiffness to maintain the shape of the pad and support the sealing effect. Furthermore, the reduced maximum thickness allows the single layer of the seal-forming structure 3100 to compress a greater distance compared to the previous double-layer design, thereby allowing increased compliance before bottoming out.

[0308] International patent application publication WO 2014 / 117227 discloses a system with a face mask in which a foam pad is supported by a flexible clip attached to a second, more rigid clip, the patent application of which is hereby incorporated by reference in its entirety. Figure 21 A similar system is disclosed, but with two ribs 3155 already incorporated, wherein the ribs are configured on opposite sides of the patient's nose. Figure 21 Only one rib is visible. These ribs act as straps to prevent the flexible clips and attached foam seals from being ejected. Although rib 3155 is shown, strap 3110 can be used instead of rib 3155.

[0309] Therefore, in another embodiment of this technology, the sealing structure 3100 may include a pad 3810 that can be made of foam. The pad is defined to circumferentially cover a single area of ​​the patient's nose in the case of a nasal mask and circumferentially cover a single area of ​​the nose and mouth in the case of a full-face mask. The foam pad may be made of, for example, any suitable material, such as one or more of the following exemplary materials: polyethylene, polyurethane, ethylene-vinyl acetate (EVA). In some cases, the foam pad may be a semi-open closed-cell foam, such as foam made of polyurethane. A semi-open-cell foam pad may have limited permeability, as described in more detail in International Patent Application Publication WO 2014 / 117227, wherein the permeability disclosed therein is incorporated herein by reference.

[0310] The pad 3810 may have a generally triangular or pear-shaped shape with a sealing surface that conforms to the contours of the user's face. The foam pad is designed to attach to a first support (e.g., flexible) clip 3812, which itself is attached to a second, more rigid clip 3814 (e.g., Figure 22 (As shown in the diagram) or directly attached to the mask housing 3816. In one embodiment, the first support clip 3812 may be a flexible clip that is more rigid than the foam pad, but softer or more flexible than the second clip 3814. It is the combination of the foam and the flexible clip that defines the physical properties of the overall sealed interface. The flexible clip allows the interface to adapt to major changes and successfully conform to the contours of the patient's face. The compliant nature of the foam pad provides micro-adjustments and forms a comfortable interface layer that interacts with the patient's skin.

[0311] Due to its flexible and compliant nature, the first support clip 3812 may be easily ejected. Figure 21 Another aspect of the present technology is shown, which can prevent the first support clip 3812 and the attached pad 3810 from ejecting. Here, the configuration shown includes two ribs 3155 (only one is visible due to the symmetrical nature and orientation of the figure), but any number of ribs can be provided. For example, a single rib or three or more ribs can be provided. Similar to the ties 3110, each rib 3155 tends to prevent the first support clip 3812 and the attached pad 3810 from ejecting by acting as a tension member. The ribs can have the same thickness or different thicknesses. For example, one or both ribs 3155 can be about 1 mm thick, and one or both ribs 3155 can be about 0.5 mm thick. Alternatively, the ribs can have variable thicknesses. The ribs 3155 can be positioned adjacent to the patient's nose.

[0312] Figure 21A side view of a pad assembly 3800 including a seal-forming structure 3100 is shown. The pad assembly includes a mask housing 3816, a permanently attached flexible first support clip 3812, and a foam pad 3810. As shown, the flexible first support clip can be secured to the mask housing 3816 via a pair of ribs 3155 acting as straps to prevent ejection. The ribs 3155 can be relatively compliant under compression or easily crushed under seal load, thereby allowing the seal-forming structure 3100 to adapt to the patient's face. The tension provided by the ribs 3155 can be adjusted by changing any one or more of their material composition, geometry, or location.

[0313] Figure 23 The foam pad 3810 and the flexible first support clip 3812 are shown, with the patient contact surface visible. Figure 23A Is along through Figure 23 The cross-section is taken from the vertically symmetrical plane and shows the foam pad, the flexible first support clip 3812 and the rib 3155.

[0314] In another embodiment of this technology, the sealing structure 3100 may include a pair of straps 3110 to prevent ejection of the first support clip 3812. Each strap 3110 is formed by folding inwards into the flexible support clip 3812 having an outer periphery to form a connection point 3165. In this way, the straps 3110 can form a substantially tubular structure 3120. The straps form a tether to resist ejection due to internal pressurization of the inflation chamber. The tension provided by the ribs 3155 can be adjusted by changing their material composition, the geometry or position of the connection points 3165 of the positioning ribs 3110, or any one or more other methods.

[0315] Figure 24-27 A sealing structure 6000 similar to the sealing structure 3100 is shown, except as otherwise herein. The same reference numerals are similar to those for the sealing structure 3100 described above, and therefore will not be repeated here. Figure 24-27 The sealing structure 6000 shown can have features typically applicable to nasal masks.

[0316] Figure 25B –25G also shows Figure 25A The various cross sections, wherein the intersection of the cross sections illustrates that the sealing forming structure 6000 includes various saddles and domes. For simplicity, the intersection of the various cross sections is referred to herein by their acronym. For example, the intersection of the cross section taken along line 25B-25B and the cross section taken along line 25C-25C is referred to as intersection BC.

[0317] A cross BC is obtained at a first saddle-shaped region configured to contact the patient's nasal ridge below the nasal bridge point. The curvature is relatively small along lines 25B-25B and relatively large along lines 25C-25C. The curvature along lines 25B-25B is large enough that the first saddle-shaped region is nearly cylindrical. The first saddle-shaped region may be cylindrical if desired. A cross BD is obtained at a second saddle-shaped region configured to contact the patient's upper lip. The curvature along lines 25B-25B is relatively small compared to that along lines 25D-25D. A cross CF is obtained at a first dome-shaped region configured to contact the patient's nose adjacent to the nasal ridge. The curvature is relatively similar along lines 25F-25F and along lines 25C-25C. A cross FG is obtained at a third saddle-shaped region formed by frenulum 3110, configured to contact the patient's nose adjacent to the nasal ridge. The curvature along lines 25F-25F is relatively small and close to zero. The curvature along lines 25G-25G is relatively large compared to lines 25F-25F. Therefore, the third saddle-shaped region is approximately cylindrical, and thus can be cylindrical if preferred. The cross EF is obtained at the second dome region, which is configured to contact the patient next to the nasal ala. The curvatures along lines 22E-22D and 22F-22F are relatively similar.

[0318] Figure 27 A view of the sealing structure 6000 is shown, except that a pattern is included on the sealing structure 6000. The pattern represents a region 6005 of the sealing structure 6000 with similar properties and / or thickness.

[0319] The region 6005A, referred to herein as the nose region, may have a thickness of approximately 0.5 mm, which can prevent wrinkling and / or creases in the sealing structure 6000 in this region.

[0320] The region 6005B, referred to herein as the base region, may have a thickness between approximately 2.9 mm and 3.45 mm. For example, the thickness may be 2.9 mm at 6005B2, 3.0 mm at 6005B1 and 6005B3, and 3.45 mm at 6005B4. Region 6005B may provide support or a base for the sealing sheet 3125 and may provide and maintain the overall shape of the sealing formation structure 6000.

[0321] Region 6005C (referred to herein as the base area) may have a thickness ranging from 0.95 mm to 2.1 mm. As shown, this region may be the main area of ​​the pad. For example, region 6005C may be approximately 50% of the pad. The thickness of the upper portion of region 6005C1 may be between 0.95 mm and 1.6 mm, while the thickness of the lower portion of region 6005C2 may be between 1.25 mm and 2.1 mm. The thickness may vary continuously between these values ​​to provide a smooth appearance.

[0322] The region 6005D, referred to herein as the membrane region, may form approximately one-third of the seal-forming structure 6000 and may include a tether 3110. The thickness may be approximately 0.35 mm. This region may be relatively thin to allow it to be used as an energized (e.g., pressure-activated) seal against the patient's face. The side portion 6005D1 may be substantially parallel to the patient's face, which can reduce the likelihood of wrinkling and thus leakage. Such wrinkling may be more likely to occur under dynamic conditions, such as when the seal is in motion.

[0323] The region 6005F referred to herein as the spring region can have a thickness ranging from 1.1 mm to 1.8 mm. This region can be used as a spring and allows compression on top to reduce the pressure on it. This region can gradually harden from the center of the upper lip where region 6005F is strongest to the center of the nasal corner (e.g., the apex of the nostril).

[0324] Region 6005G, referred to herein as the nasal collapse region, may be relatively deep to better accommodate patients with relatively high nasal bridges and / or provide a more comfortable seal. This region may have a similar thickness to region 6005D (e.g., approximately 0.35 mm) and may therefore be a subregion of region 6005D.

[0325] When used to describe the first support clip 3812 in this specification, the terms "soft" and "flexible," and their derivatives, are intended to mean "elastic," as specifically defined in the section "Terminology for Patient Interface Use." That is, the flexible support clip is capable of deforming substantially elastically and rapidly releasing substantially all of its energy upon unloading.

[0326] The seal-forming structure 3100 can have advantages in one or more forms of the present technology. For example, when designed for a seal for many facial variations, the human facial structure can include individual variations that present challenges. These variations can include different shapes of the facial structure (e.g., different shapes of the nose and / or different curvatures of the cheeks) and / or different tissue contents (e.g., more or less adipose tissue). These variations can result in a previous seal-forming structure that is very good for one person but poor for another. Furthermore, perceived comfort can vary from person to person independently of facial structure. Using the seal-forming structure 3100 described herein, a higher percentage of users can effectively use the seal-forming structure 3100 compared to existing seal-forming structures (e.g., a higher percentage of users can make the seal-forming structure 3100 form an effective seal and / or a higher percentage of users can perceive the seal-forming structure 3100 as comfortable).

[0327] Figures 28A to 28M An exemplary full-seal formation structure 3100 including a tie 3110 is depicted. (As can be seen in...) Figure 28K As can be seen, for example, the tether 3110 may extend between a first inner surface region 3180 and a second inner surface region 3185. The first inner surface region 3180 can be understood as being opposite to the sealing surface 3105 of the sealing structure. The second inner surface region 3185 can be understood as being located elsewhere. In the example shown in FIG. 28k, the second inner surface region 3185 is located inside the sealing structure 3100. In other examples, the second inner surface region 3185 may be located inside the inflation chamber 3200, such that the tether 3110 extends between the sealing structure 3100 and the inflation chamber 3200. The position of the second inner surface region 3185 may be selected based on the desired directional component of the tension vector of the tether 3100 resisting the ejection force.

[0328] Figure 28L and 28M A detailed cross-sectional view is shown, specifically at connection point 3165, where the tether 3110 extends from the second inner surface region 3165. In this example, connection point 3165 may be curved to reduce stress concentration in this region, thereby reducing the tendency of the tether 3110 to tear. Furthermore, the tether 3110 may extend from the second inner surface region 3185 at a distance from the bonding region 3190, where the seal-forming structure 3100 is bonded to the inflation chamber 3200 during formation. This prevents damage to the tether 3110 when the seal-forming structure 3100 is bonded to the inflation chamber 3200. Figures 29C to 29E It is also shown how the tether 3110 extends from the second inner surface region 3185 at a distance from the bonding region 3190 and the air chamber 3200.

[0329] Figures 28J to 28L The cross-sectional view also shows the location where the tether 3110 may extend from the first inner surface region 3180. As can be seen in these examples, the tether 3110 extends from the first inner surface region 3110 near the sealing strip 3125 rather than at the sealing strip itself. However, in alternative examples, the tether 3110 may extend from the first inner surface region 3180 closer to or at the edge of the sealing strip 3125.

[0330] Figure 30A and 30B An example of a full patient interface 3000 including a sealing formation structure 3100 having the features of this technology is depicted, but the positioning and stabilization structure 3300 is not depicted.

[0331] Figures 31A to 31M Another example of this technology is depicted as a nasal seal forming structure 3100. For example, it can be seen that... Figure 31K As can be seen, for example, the tether 3110 extends continuously from the sealing strip 3125. Therefore, there may be no defined edge in this area. Furthermore, it should be understood that, depending on the patient's facial anthropometrics, at least a portion of the tether 3110 in this arrangement may form part of the sealing surface 3105 in use.

[0332] Figures 32C to 32E As shown in the example of the nasal patient interface 3000, compared to the full patient interface 3000, the frenulum 3110 may extend from the second inner surface region 3185 at another distance from the bonding region 3190.

[0333] 5.3.2 Inflation Chamber

[0334] In the sealed area formed during use, the inflation chamber 3200 has a periphery whose shape complements the surface contour of a typical human face. During use, the boundary edge of the inflation chamber is extremely close to the adjacent surface of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 can extend along the entire periphery of the inflation chamber 3200 during use.

[0335] In some forms of this technology, the air chamber 3200 is made of a transparent material, such as transparent polycarbonate. Using transparent materials reduces barriers to the patient interface and helps improve treatment adherence. Transparent materials also help clinicians observe how the patient interface is positioned and functions.

[0336] In some forms of this technology, the air chamber 3200 is made of a translucent material. Using a transparent material can reduce barriers to the patient interface and help improve treatment adherence.

[0337] 5.3.3 Positioning and Stabilizing Structure

[0338] The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by positioning and stabilizing structure 3300.

[0339] In one configuration, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the effect of positive pressure on the peeling face in the air chamber 3200.

[0340] In one configuration, the positioning and stabilizing structure 3300 provides a holding force to overcome the effect of gravity on the patient interface 3000.

[0341] In one configuration, the positioning and stabilizing structure 3300 provides a retaining force as a safety boundary to overcome potential effects of disturbance forces on the patient interface 3000, such as from tube resistance or unintended interference with the patient interface.

[0342] In one form of this technology, a positioning and stabilization structure 3300 is provided, constructed in a manner consistent with that worn by a patient while sleeping. In one embodiment, the positioning and stabilization structure 3300 has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one embodiment, the positioning and stabilization structure 3300 includes at least one strip with a rectangular cross-section. In one embodiment, the positioning and stabilization structure 3300 includes at least one flat strip.

[0343] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured not to be too large or bulky to prevent the patient from lying in a supine position, wherein the posterior region of the patient's head is on a pillow.

[0344] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured not to be too large or bulky to prevent the patient from lying in a lateral position, wherein the lateral area of ​​the patient's head is on a pillow.

[0345] In one form of this technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminated material comprising a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In another form, the fabric outer layer includes a tie material for engagement with a hook material portion.

[0346] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For example, the strap may be configured to withstand tensile forces during use and to guide forces to ensure a sealed contact between the pad and a portion of the patient's face. In one embodiment, the strap may be configured as a tie.

[0347] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is flexible, for example, non-rigid. An advantage of this is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0348] In some forms of this technology, the positioning and stabilizing structure 3300 includes a belt configured to be breathable to allow moisture to pass through.

[0349] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide holding forces corresponding to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for a large-sized head rather than a small-sized head; and another form of positioning and stabilizing structure suitable for a small-sized head rather than a large-sized head.

[0350] 5.3.4 Exhaust Port

[0351] In one form, the patient interface 3000 includes an exhaust port 3400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0352] One form of the exhaust port 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0353] The exhaust port 3400 may be located in the inflation chamber 3200. Alternatively, the exhaust port 3400 may be located in a decoupling structure, such as a rotating shaft.

[0354] 5.3.5 Decoupling Structure

[0355] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball-and-socket joint.

[0356] 5.3.6 Connection Port

[0357] Connection port 3600 allows connection to air circuit 4170.

[0358] 5.3.7 Forehead Stent

[0359] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0360] 5.3.8 Anti-asphyxiation valve

[0361] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0362] Port 5.3.9

[0363] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to provide supplemental oxygen. In one embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0364] 5.4RPT device

[0365] According to one aspect of the present invention, an RPT device 4000 includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300. The RPT device 4000 can be configured to generate an airflow for delivery to a patient's airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0366] The RPT device may have an outer housing 4010, which is composed of two parts: an upper part 4012 and a lower part 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0367] The pneumatic path of the RPT device 4000 may include one or more air path components, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying positive pressure air, an outlet silencer 4124, and one or more converters 4270, such as a pressure sensor 4272 and a flow rate sensor 4274.

[0368] One or more air path components may be housed within a detachable, separate structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be housed within an outer housing 4010. In one embodiment, pneumatic block 4020 is supported by, or forms part of, a chassis 4016.

[0369] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a converter 4270, a data communication interface 4280, and one or more output devices 4290. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative embodiment, the RPT device 4000 may include more than one PCBA 4202.

[0370] 5.4.1 Mechanical & Pneumatic Components of the RPT Unit

[0371] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be configured as separate units.

[0372] 5.4.1.1 Air Filter

[0373] One form of RPT device according to the present technology may include one air filter 4110 or multiple air filters 4110.

[0374] In one configuration, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0375] In one configuration, an outlet air filter 4114, such as an antibacterial filter, is positioned between the pneumatic block 4020 and the patient interface 3000.

[0376] 5.4.1.2 Muffler

[0377] One form of RPT device according to the present technology may include one or more mufflers 4120.

[0378] In one embodiment of this technology, the inlet silencer 4122 is disposed in the pneumatic path upstream of the pressure generator 4140.

[0379] In one embodiment of this technology, the outlet silencer 4124 is disposed in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0380] 5.4.1.3 Pressure Generator

[0381] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers enclosed in a volute. The blower is capable of delivering an air supply, for example, at a rate up to about 120 liters per minute and at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be as described in any of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO2013 / 020167.

[0382] The pressure generator 4140 is controlled by the treatment device controller 4240.

[0383] In other words, the pressure generator 4140 can be a piston-driven pump, a pressure regulator (e.g., a compressed air reservoir) connected to a high-pressure source, or a bellows.

[0384] 5.4.1.4 Converter

[0385] The transducer can be located inside or outside the RPT device. An external transducer can be located on, for example, the air circuit, such as the patient interface, or be part of it. An external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.

[0386] 5.4.2 Electrical Components of the RPT Device

[0387] 5.4.2.1 Power Supply

[0388] The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.

[0389] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of the invention, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.

[0390] 5.4.2.2 Input Device

[0391] In one embodiment of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow personnel to interact with the device. The buttons, switches, or dials can be physical devices or software devices accessed via a touchscreen. In one embodiment, the buttons, switches, or dials can be physically connected to an external housing 4010, or in another embodiment, the buttons, switches, or dials can communicate wirelessly with a receiver electrically connected to a central controller.

[0392] 5.4.2.3 Includes optional display and alarm output devices.

[0393] The output device according to this technology can take the form of one or more visual, auditory, and tactile units. The visual display can be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0394] 5.5 Air Circuit

[0395] According to one aspect of the present technology, the air circuit 4170 is a conduit or tube that is constructed and arranged in use to allow airflow between two components, such as the RPT device 4000 and the patient interface 3000.

[0396] Specifically, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, a circuit with separate branches may be used for inhalation and exhalation. In other cases, a single branch is used.

[0397] In some forms, the air circuit 4170 may include one or more heating elements configured to heat air in the air circuit, for example, to maintain or raise the temperature of the air. The heating elements may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating elements may be connected to a controller, such as a central controller. An embodiment of a control circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0398] 5.6 Humidifier

[0399] 5.6.1 Overview of Humidifiers

[0400] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 3V and 3W As shown in the diagram, the humidifier 5000 is used to change the absolute humidity of the air or gas intended for delivery to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0401] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving airflow, and a humidifier outlet 5004 for delivering humidified airflow. In some forms, such as Figure 3V and Figure 3W As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which is adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.

[0402] 5.6.2 Humidifier Components

[0403] 5.6.2.1 Water Storage Tank

[0404] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to maintain or retain a liquid (e.g., water) volume for evaporation to humidify the airflow. The water reservoir 5110 may be configured to maintain a predetermined maximum water volume to provide adequate humidification for at least the duration of a respiratory therapy session, such as one night of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 ml, 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply system.

[0405] According to one aspect, the water reservoir 5110 is configured to add moisture to the airflow from the RPT device 4000 when airflow passes through it. In one form, the water reservoir 5110 may be configured to facilitate the airflow traveling in a curved path through the reservoir 5110 when in contact with the water volume therein.

[0406] According to one form, the storage 5110 can, for example, be along such a path. Figure 3V and Figure 3W Remove from humidifier 5000 in the lateral direction shown.

[0407] The reservoir 5110 may also be configured to prevent liquid from flowing out through any orifice and / or from its sub-assemblies when the reservoir 5110 is displaced and / or rotated from its normal operating direction. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to avoid loss of pneumatic pressure through leakage and / or flow resistance.

[0408] 5.6.2.2 Air Guide Section

[0409] According to one arrangement, the reservoir 5110 includes a vent 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume within the reservoir 5110. In one form, the vent 5120 may be a plate, but other shapes are equally applicable. All or part of the vent 5120 may be made of a thermally conductive material, such as aluminum (e.g., with a thickness of about 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity can be achieved using materials with appropriate geometries and lower thermal conductivity.

[0410] 5.6.2.3 Humidifier reservoir base

[0411] In one embodiment, the humidifier 5000 may include a humidifier reservoir base 5130 (e.g., Figure 3VAs shown, it is configured to receive humidifier reservoir 5110. In some arrangements, humidifier reservoir base 5130 may include a locking mechanism, such as a locking lever 5135 configured to hold reservoir 5110 in humidifier reservoir base 5130.

[0412] 5.6.2.4 Water level indicator

[0413] Humidifier reservoir 5110 may include, for example Figure 3V-3W The water level indicator 5150 is shown. In some forms, the water level indicator 5150 may provide one or more indications to a user (such as a patient 1000 or a caregiver) regarding the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0414] 5.6.2.5 Heating element

[0415] In some cases, heating element 5240 may be provided to humidifier 5000 to provide heat input to one or more of the water capacity in humidifier reservoir 5110 and / or to airflow. Heating element 5240 may include heat-generating components, such as resistive electric heating rails. A suitable example of heating element 5240 is a layered heating element, such as the layered heating element described in PCT patent application publication number WO2012 / 171072, which is incorporated herein by reference in its entirety.

[0416] In some forms, the heating element 5240 may be provided in the humidifier base 5006, wherein, for example Figure 3W The heat shown can be supplied to the humidifier reservoir 5110 primarily through conduction.

[0417] 5.7 Vocabulary

[0418] To achieve the purpose of disclosing the technology of this invention, one or more of the following definitions may be applied in certain forms of the invention. In other forms of the invention, alternative definitions may be applied.

[0419] 5.7.1 General Rules

[0420] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0421] environment:In certain forms of the present invention, the term "environment" may have the following meanings: (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0422] For example, the ambient humidity relative to the humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's sleeping room. This ambient humidity can differ from the humidity outside the patient's sleeping room.

[0423] In another instance, environmental stress can be stress that is directly around the body or outside the body.

[0424] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room, excluding noise generated by, for example, the RPT device or from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0425] Automated positive airway pressure (APAP) therapy: The treatment pressure is automatically adjustable between minimum and maximum for CPAP therapy, varying with each breath, depending on the presence of an indication of an SBD event.

[0426] Continuous positive airway pressure (CPAP) therapy: The treatment pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in the absence of such an indication.

[0427] flow: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be a scalar quantity, i.e., a quantity that has only quantity. In other cases, the reference to flow rate will be a vector quantity, i.e., a quantity that has both quantity and direction. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated as 'flow'.

[0428] In the context of patient breathing, flow rate can be nominally positive for the inspiratory portion of the respiratory cycle and therefore negative for the expiratory portion. Total flow rate ( Qt The airflow rate is the air volume leaving the RPT unit. (Air exchange rate) Qv Leakage flow rate is the airflow leaving the exhaust port to allow exhaled air to flush out the air. Ql ) is the leakage flow from the patient interface system. Respiratory flow ( Qr ( ) is the airflow received into the patient's respiratory system.

[0429] Humidifier The term humidifier is generally considered to refer to a humidification device that is constructed and arranged or configured with a physical structure to provide a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve a patient's medical respiratory symptoms.

[0430] leakage: A leak would be considered an unwanted airflow. In one instance, a leak could occur due to an incomplete seal between the mask and the patient's face. In another instance, a leak could occur in a bend in the conduit leading to the surrounding environment.

[0431] Noise, conducted (acoustic): Conducted noise in this article refers to noise delivered to the patient through pneumatic paths (such as 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.

[0432] Noise, radiated (acoustic): Radiated noise in this article refers to noise delivered to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object under discussion according to ISO 3744.

[0433] Noise, ventilation (acoustic): In this article, ventilation noise refers to the noise generated by the flow of air through any exhaust port (such as an exhaust port in a patient interface).

[0434] patient: People, regardless of whether they have respiratory symptoms.

[0435] pressure: Force per unit area. Pressure can be expressed in units (including cmH2O, gf / cm²). 2 Measured within the range of (and hectopascals). 1 cmH2O equals 1 gf / cm³. 2 It is approximately 0.98 hectopascals. In this specification, unless otherwise stated, pressure is given in cmH2O.

[0436] Pressure in the patient interface is represented by symbols Pm Give, and treat stress with symbols Pt The treatment pressure is given as the pressure exerted through the mask at the current moment. Pm The target value obtained.

[0437] Respiratory pressure therapy (RPT): Air is supplied to the airway inlet at a therapeutic pressure that is typically positive relative to atmospheric pressure.

[0438] Ventilator: Mechanical devices that provide pressure support to patients to perform some or all of their breathing tasks.

[0439] 5.7.1.1 Materials

[0440] Silicone resin or silicone elastomer: Synthetic rubber. In this specification, reference to silicone rubber refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0441] Polycarbonate: A typical transparent thermoplastic polymer of bisphenol A carbonate.

[0442] 5.7.1.2 Mechanical Properties

[0443] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during venting.

[0444] Resilient When vented, it releases virtually all of its energy. This includes certain silicones and thermoplastic elastomers.

[0445] hardness: The material’s own resistance to deformation (e.g., as described by Young’s modulus, or by an indentation hardness scale measured on a standard sample size).

[0446] 'Soft' materials may include silicone or thermoplastic elastomers (TPEs) and may deform easily, for example, under finger pressure.

[0447] 'Hard' materials can include polycarbonate, polypropylene, steel or aluminum, and can be, for example, not easily deformed under finger pressure.

[0448] The stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. A structure or component can provide different resistances in different directions.

[0449] Soft structures or components: Structures or components that will change shape, such as bending, when subjected to a relatively short period of time, such as 1 second, to support their own weight.

[0450] Rigid structures or components: A structure or component that will not change shape substantially when subjected to the loads typically encountered during use. One example of this use is setting and maintaining a patient interface in a sealed relationship with the inlet of the patient's airway, for example, under a load of approximately 20 to 30 cmH2O.

[0451] As an example, an I-beam can exhibit different flexural stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component is flexible in the first direction and rigid in the second direction.

[0452] 5.7.2 Respiratory and Circulatory Systems

[0453] Respiratory arrest: According to some definitions, respiratory arrest is said to have occurred when airflow drops below a predetermined threshold for a sustained period (e.g., 10 seconds). Respiratory arrest is also said to have occurred when, despite the patient's efforts, some obstruction of the airway prevents airflow. Central respiratory arrest is said to have occurred when respiratory arrest is detected due to reduced or absent respiratory effort, even though the airway is open. Mixed respiratory arrest occurs when a reduction or absence of respiratory effort coincides with airway obstruction.

[0454] respiratory rate The patient’s spontaneous respiratory rate is usually measured in breaths per minute.

[0455] Duty cycle Inhalation time ( Ti ) and total respiratory time ( Ttot The ratio of ).

[0456] Try to breathe. The work done by spontaneously breathing individuals as they attempt to breathe.

[0457] Expiratory phase of the respiratory cycle The time period from the start of exhalation to the start of inhalation.

[0458] Traffic limits Flow restriction is considered a state of breathing in which increased effort by the patient does not result in a corresponding increase in flow. Flow restriction occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow restriction. Flow restriction occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow restriction.

[0459] Inhalation waveforms limited by flow rate type:

[0460] (i) flat It has an upward section followed by a relatively flat section, and then a downward section.

[0461] (ii) M-shapedIt has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.

[0462] (iii) Chair-shaped It has a single local peak at the leading edge, followed by a relatively flat portion.

[0463] (iv) Reverse chair shape It has a relatively flat portion, followed by a single local peak at the trailing edge.

[0464] Insufficient breathing According to some definitions, inadequacy is considered a decrease in flow, but not a cessation of flow. In one form, inadequacy can be said to have occurred when flow drops below a threshold for a sustained period. Central inadequacy is said to have occurred when inadequacy is detected due to reduced respiratory effort. In one form for adults, any of the following can be considered inadequacy:

[0465] (i) A 30% reduction in the patient's respiration lasting for at least 10 seconds, plus a corresponding 4% reduction in saturation; or

[0466] (ii) The patient’s breathing is reduced (but at least 50%) for at least 10 seconds, accompanied by a decrease in saturation of at least 3% or arousal.

[0467] hyperventilation Traffic volume increases to levels higher than normal.

[0468] Inspiratory phase of the respiratory cycle The time period from the start of inhalation to the start of exhalation is considered the inhalation portion of the respiratory cycle.

[0469] Open airway : The degree to which the airway is open, or the degree to which the airway is open. The patient's airway is open. The openness of the airway can be quantified, for example, by using a value of -1 (1) for open and a value of zero (0) for closed (obstructed).

[0470] Positive end-expiratory pressure (PEEP) The pressure above atmospheric pressure present in the lungs at the end of exhalation.

[0471] Peak flow (Q peak) The maximum flow rate during the expiratory portion of the respiratory flow waveform.

[0472] Respiratory flow rate, patient air flow rate, respiratory air flow rate (Qr) These terms can be understood as referring to the RPT device's estimate of respiratory airflow, as opposed to "true respiratory flow" or "real respiratory airflow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0473] Tidal volume (Vt)The volume of air inhaled or exhaled during normal breathing without additional effort.

[0474] (Inhalation) Time (Ti) The duration of the inspiratory portion of the respiratory flow waveform.

[0475] (Exhalation) Time (Te) The duration of the expiratory portion of the respiratory flow waveform.

[0476] (Total) Time (T_total) The total duration between the start of the inspiratory portion of the respiratory flow waveform and the start of the subsequent inspiratory portion of the respiratory flow waveform.

[0477] Typical recent ventilation The central tendency of recent values ​​of ventilation volume on some predetermined time scales tends to cluster around them; that is, the measurement of the central tendency of recent values ​​of ventilation volume.

[0478] Upper airway obstruction (UAO) This includes both partial and complete upper airway obstruction. This can be associated with a state of flow restriction, where the flow rate increases only slightly or even decreases with an increase in the pressure gradient across the upper airway (Starling resistance behavior).

[0479] Ventilation volume (Vent) Ventilation volume is a measurement of the flow rate of gases exchanged by a patient's respiratory system. Measurements can include one or both of the inspiratory and expiratory flow rates per unit time. When expressed in volumes per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes given only in volume form and is understood as volumes per minute.

[0480] 5.7.3 Ventilation rate

[0481] Adaptive Servo Ventilator (ASV) A servo ventilator with a variable target ventilation volume instead of a fixed target ventilation volume. The variable target ventilation volume can be determined from some characteristics of the patient, such as the patient's respiratory characteristics.

[0482] spare frequency Establish the ventilator parameters that, if not caused by spontaneous breathing effort, will deliver the minimum respiratory rate (typically measured in breaths per minute) to the patient.

[0483] Looping Termination of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a patient who is breathing spontaneously, the ventilator is said to be in cycle 2000 to stop delivering breaths at the end of the inspiratory portion of the respiratory cycle.

[0484] Positive expiratory airway pressure (EPAP) Base pressure: The pressure that is added to the ventilator to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0485] End-expiratory pressure (EEP) The ventilator will attempt to achieve the desired mask pressure at the end of the expiratory phase of breathing. If the pressure waveform template Π(Φ) is zero at the end of expiration, i.e., Π(Φ) = 0 when Φ = 1, then EEP equals EPAP.

[0486] Inspiratory Positive Airway Pressure (IPAP) The maximum desired mask pressure that the ventilator will attempt to achieve during the inspiratory phase of breathing.

[0487] Pressure support: Indicates the pressure increase during inspiratory breathing that exceeds the pressure increase during expiratory breathing, and generally refers to the pressure difference between the maximum pressure during inspiration and the baseline pressure (e.g., PS = IPAP-EPAP In some cases, pressure support refers to the difference between the planned and actual ventilator support.

[0488] Servo ventilator: A ventilator that measures the patient’s ventilation volume, has a target ventilation volume, and adjusts the pressure support level to bring the patient’s ventilation volume toward the target ventilation volume.

[0489] Spontaneous / Timed (S / T) This device attempts to detect the pattern of spontaneous breathing in patients and initiate the operation of a ventilator or other device. However, if the device fails to detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.

[0490] Swing difference: an equivalent term for pressure support.

[0491] Caused When a ventilator delivers air to a patient who is breathing spontaneously, it is said to be initiated at the beginning of the respiratory phase of the respiratory cycle by the patient's effort.

[0492] Typical recent ventilation Typical recent ventilation (Vtyp) refers to recent measurements of ventilation over a predetermined time scale that tend to cluster around it. For example, a measurement of the central tendency of recent historical ventilation measurements could be a suitable value for typical recent ventilation.

[0493] 5.7.4 Anatomical Structure

[0494] 5.7.4.1 Facial Anatomy

[0495] nostrils The outer walls or "wings" of each nostril (plural: nasal wings)

[0496] Nasal alar tip The outermost point on the ala of the nose.

[0497] The point of the nasal wing curve (or the tip of the nasal wing)The last point in the curved baseline of each nasal ala, found in the fold formed by the junction of the nasal ala and the cheek.

[0498] auricle The entire visible external portion of the ear.

[0499] (Nose) skeleton The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0500] (Nose) Soft cartilage The nasal cartilage includes the septum, lateral septum, and major and minor cartilages.

[0501] columella : A strip of skin separating the nostrils and extending from the nasal protuberance to the upper lip.

[0502] columellar angle The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt plane (the two lines intersect at the lower point of the nasal septum).

[0503] Frankfurt Plan The line extending from the lowest point of the eye socket edge to the left cochlea. The cochlea is the deepest point in the notch on the upper part of the tragus of the auricle.

[0504] Between the eyebrows Located on the soft tissue, it is the most prominent point in the midsagittal plane of the forehead.

[0505] Nasal external cartilage It is generally a triangular cartilaginous plate. Its upper edge is attached to the nasal bone and the frontal process of the maxilla, and its lower edge is connected to the greater alar cartilage.

[0506] Greater nasal cartilage The nasal cartilage plate is located beneath the external nasal cartilage. It curves around the front of the nostrils. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four small cartilages.

[0507] Nostrils (eyes) The nostril is an approximately oval-shaped opening that forms the entrance to the nasal cavity. The singular form of the nostril is the nasal cavity (or nasal eye). The nostril is separated by the nasal septum.

[0508] Nasolabial folds or nasolabial folds The skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0509] Nasolabial angle The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0510] base point under ear The auricle is attached to the lowest point of the facial skin.

[0511] Ear base point The auricle is attached to the highest point of the facial skin.

[0512] Nasal protuberance The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0513] philtrum The midline groove extends from the lower border of the nasal septum to the top of the upper lip in the upper lip region.

[0514] Prechin Located on the soft tissue, at the midpoint of the front part of the chin.

[0515] Back (nose) The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0516] sagittal plane The vertical plane that divides the body into the right and left halves, passing from the front to the back.

[0517] bridge of the nose Located on the soft tissue, it is the most concave point covering the frontonasal suture area.

[0518] Septal cartilage (nose) The nasal septum cartilage forms part of the septum and divides the anterior part of the nasal cavity.

[0519] Rear upper side plate : The point at the lower edge of the base of the nasal ala, where the base of the nasal ala connects to the skin of the upper (superior) lip.

[0520] Subnasal point Located on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0521] Mandibular alveolar seat The point on the midline of the lower lip where the greatest concavity occurs between the midpoint of the lower lip and the premental point of the soft tissue.

[0522] 5.7.4.2 Anatomical Structure of the Skull

[0523] Frontal bone The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0524] mandible The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0525] maxilla The maxilla forms the upper jaw and lies above the lower jaw and below the eye socket. The frontal process of the maxilla extends upward from the side of the nose and forms part of the lateral boundary.

[0526] Nasal boneThe nasal bones are two oval-shaped bones whose size and shape vary among individuals; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0527] Root of the nose The point where the frontal bone intersects with the two nasal bones, located directly between the eyes and in the depression at the top of the bridge of the nose.

[0528] occipital bone The occipital bone is located at the back and lower part of the skull. It includes an oval foramen (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0529] eye socket The bony cavity in the skull that houses the eyeball.

[0530] parietal bone The parietal bone is the top and sides of the skull that, when joined together, form the top of the skull.

[0531] Temporal bone The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0532] cheekbones The face includes two cheekbones, which are located on the upper and side parts of the face and form the protruding parts of the cheeks.

[0533] 5.7.4.3 Anatomical Structure of the Respiratory System

[0534] diaphragm The diaphragm is a muscular plate that extends across the bottom of the ribcage. It separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0535] throat The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0536] lung The lungs are the human respiratory organs. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0537] nasal cavity The nasal cavity (or nasal socket) is a large, air-filled space located in the middle of the face above and behind the nose. It is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular: "nasal conchae"). The front of the nasal cavity is the nasal part, while the back connects to the nasopharynx via the internal nasal openings.

[0538] pharynxThe pharynx is a part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is routinely divided into three parts: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the larynx), and the laryngopharynx (hypopharynx).

[0539] 5.7.5 Patient Interface

[0540] Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0541] Bending pipe: A bend is an example of a structure in which the axis guiding airflow changes direction by an angle. In one form, this angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The bend can have an approximately circular cross-section. In another form, the bend can have an elliptical or rectangular cross-section. In some forms, the bend can rotate relative to the mating assembly, for example, by approximately 360 degrees. In some forms, the bend can be detachable from the mating assembly, for example, by a snap-fit ​​connection. In some forms, the bend can be assembled to the mating assembly during manufacturing using a one-time snap-fit, but cannot be removed by the patient.

[0542] Frame: The frame is generally considered to refer to a mask structure that bears tensile loads between two or more connection points with head straps. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0543] Headband: A headband is considered to refer to a form of positioning and stabilization structure designed for use on the head. For example, a headband may include an assembly of one or more support bars, straps, and reinforcing bars configured to position and hold the patient interface on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, and resilient materials, such as laminated composites of foam and fabric.

[0544] membrane The term "membrane" is to be understood as referring to a typically thin element that is preferably substantially non-flexural but tensile.

[0545] Inflation chamber: The mask inflation chamber is considered to be part of a patient interface having walls that surround a volume of space, which, when in use, contains air pressurized to above atmospheric pressure. A housing may form part of the walls of the mask inflation chamber.

[0546] seal: can be the noun form indicating structure ("seal") or the verb form indicating function ("to seal"). Two elements can be constructed and / or arranged to seal between them or to achieve a "seal" between them without the need for a separate "seal" element itself.

[0547] case The term "shell" is considered to refer to a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0548] Reinforcing components A reinforcement is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0549] support Supports are considered to be structural components designed to increase the compressibility of another component in at least one direction.

[0550] Rotary axis (Noun) A sub-assembly of an assembly configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the rotating element may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assembly of the assembly preferably comprises a pair of mating cylindrical ducts. During use, there may be little or no airflow leakage from the shaft.

[0551] Lace (Noun): A structure designed to resist tension.

[0552] exhaust port (Noun): A structure that allows airflow from inside the mask or tubing to ambient air, for example, to allow for effective flushing of exhaled air. For example, clinically effective flushing can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute, depending on the mask design and treatment pressure.

[0553] 5.7.6 Shape of the structure

[0554] Products according to this technology may include one or more three-dimensional mechanical structures, such as face mask pads or thrusters. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a pad structure may include a surface that contacts the face (e.g., the outer surface) and separate surfaces that do not contact the face (e.g., the underside or inner surface). In yet another example, a structure may include a first surface and a second surface.

[0555] To aid in describing the shape of three-dimensional structures and surfaces, we first consider a cross-section through a point p on the surface of the structure. See [link to documentation]. Figures 3B to 3F They show an example of a cross-section at point p on the surface and the resulting planar profile. Figures 3B to 3F The outward normal vector at point p is also shown. The outward normal vector at point p is away from the surface. In some instances, the surface is described from the viewpoint of an imaginary little person standing upright on the surface.

[0556] 5.7.6.1 Curvature in one dimension

[0557] Plane curves in p The curvature at a point can be described as having a sign (e.g., positive, negative) and a quantity (e.g., only at contact with) p (The reciprocal of the radius of the circle at the curve).

[0558] Positive curvature: If in p If the curve at a point turns towards the outward normal, then the curvature at that point will be positive (if the imagined figure leaves that point). p (Then they must go uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to relatively small positive curvature). Such curves are often referred to as concave surfaces.

[0559] Zero curvature: If in p If the curve at point is a straight line, then the curvature will be zero (if the imagined figure leaves point). p Then they can walk horizontally, without going up or down. (See also...) Figure 3D .

[0560] Negative curvature: If in p If the curve at a point deviates from the outward normal, then the curvature in that direction at that point will be negative (if the imagined figure leaves that point). p (Then they must go downhill). See also Figure 3E (and Figure 3F Compared to relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to relatively large negative curvature). Such curves are often referred to as convex surfaces.

[0561] 5.7.6.2 Curvature diagram of a two-dimensional surface depicts a cross-sectional view of a patient interface worn by a patient according to an example of this technology.

[0562] A description of the shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. These cross sections may cut through the surface in a plane including an outward normal (“normal plane”), and each cross section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has a quantity, for example, a relatively small quantity. Figures 3B to 3F A planar curve in a plane can be an instance of multiple cross-sections at a specific point.

[0563] Principal curvature and principal direction: The direction of the normal plane where the curvature of the curve reaches its maximum and minimum values ​​is called the principal direction. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, and the minimum value appears Figure 3F ,therefore Figure 3B and Figure 3F It is the cross-section in the principal direction. p The principal curvature at a point is the curvature in the principal direction.

[0564] Surface area: A set of points connected on a surface. The points in the region may have similar characteristics, such as curvature or sign.

[0565] Saddle-shaped region: The region at each point has the principal curvature with opposite signs, i.e., one sign is positive and the other is negative (depending on the direction the imagined individual is turning, they can walk up or down).

[0566] Dome area: The region has the same sign for the principal curvature at each point, such as two positive ("concave dome") or two negative ("convex dome").

[0567] Cylindrical region: A region where one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is not zero.

[0568] Planar area: Surface regions where both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0569] Surface edge: The boundary or limit of a surface or area.

[0570] path: In some forms of this technique, 'path' will mean a path in a mathematical-topological sense, such as a path on a surface from... f (0) to f (1) A continuous spatial curve. In some forms of this technique, a 'path' can be described as a route or process, including, for example, a set of points on a surface. (An imagined individual's path is a path in which they walk on a surface and resemble a garden path).

[0571] Path length: In some forms of this technique, the 'path length' will be along the surface from f (0) to f (1) The distance, that is, the distance along the path on the surface. There can be more than one path between two points on the surface and such paths can have different path lengths. (The path length of an imaginary individual would be the distance they walk along the path on the surface).

[0572] Straight-line distance: Straight-line distance is the distance between two points on a surface, but without considering the surface itself. In a planar region, a path with the same length as the straight-line distance between two points on the surface can exist on the surface. In a non-planar surface, a path with the same length as the straight-line distance between two points may not exist. (For an imagined individual, straight-line distance will correspond to the distance as a 'straight line'.)

[0573] 5.7.6.3 Space Curves

[0574] Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. A space curve can be thought of as a one-dimensional piece of three-dimensional space. Imagine an imaginary individual walking along a space curve on a DNA helix. The typical human left ear includes a helix, which is a left-handed helix; see [link to relevant documentation]. Figure 3Q A typical human right ear includes a spiral, which is a right-sided spiral; see [link / reference]. Figure 3R . Figure 3S The right-hand spiral is shown. The edges of structures, such as membranes or thrusters, can follow space curves. Generally, space curves can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of how the curve detaches from the surface. Torsion has a sign and a quantity. The torsion at a point on a space curve can be characterized by reference to the tangent, normal, and binormal vector at that point.

[0575] Tangent unit vector (or unit tangent vector):For each point on the curve, the vector at that point indicates both the direction and the amount of travel from that point. The tangent unit vector is the unit vector that points in the same direction as the curve at that point. If you imagine an individual flying along the curve and stopping at a specific point, the direction of the tangent vector is the direction it would have traveled.

[0576] Unit normal vector: As the imagined individual moves along the curve, the tangent vector itself changes. The unit vector pointing in the same direction in which the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0577] Two-normal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example...). Figure 3P Alternatively, it can be done via the left-hand rule ( Figure 3O To determine.

[0578] Close plane: A plane containing a unit tangent vector and a unit principal normal vector. See also Figure 3O and Figure 3P .

[0579] Twisting of space curves: The twist at a point on a space curve is the rate of change of the binormal vector at that point. It measures the degree to which the curve deviates from the osculating plane. A space curve lying on the plane has zero twist. A space curve deviating slightly from the osculating plane will have a relatively small amount of twist (e.g., a slightly inclined spiral path). A space curve deviating significantly from the osculating plane will have a relatively large amount of twist (e.g., a sharply inclined spiral path). Reference Figure 3S Although T2 > T1, in Figure 3S The number of twists near the top helical coil is greater than Figure 3S The number of twists in the bottom spiral coil.

[0580] refer to Figure 3P According to the right-hand rule, a space curve turning in the direction of the right-hand binormal can be considered to have a right-hand positive twist (e.g., as...). Figure 3S (As shown in the right-handed spiral). A space curve deviating from the direction of the right-handed binormal can be considered to have right-handed negative twist (e.g., a left-handed spiral).

[0581] Similarly, and referring to the left-hand rule (see...) Figure 3O A space curve that turns in the direction of the left-hand secondary normal can be considered to have a positive left-hand twist (e.g., a left-hand spiral). Therefore, a positive left-hand twist is equivalent to a negative right-hand twist. See also Figure 3T .

[0582] 5.7.6.4 holes

[0583] Surfaces can have one-dimensional pores, such as pores defined by planar curves or spatial curves. Thin structures with pores (e.g., films) can be described as having one-dimensional pores. See, for example, [link to relevant documentation]. Figure 3I The one-dimensional hole in the structural surface shown is defined by a planar curve.

[0584] The structure can have two-dimensional pores, such as pores defined by a surface. For example, an inflatable tire has two-dimensional pores defined by the inner surface of the tire. In another example, a capsule having a cavity for air or gel has two-dimensional pores. See, for example, [link to relevant documentation]. Figure 3L pads and Figure 3M and Figure 3N An exemplary cross-section passing through it indicates the inner surface of the confined two-dimensional orifice. In another instance, the conduit may include a one-dimensional orifice (e.g., at its inlet or outlet) and a two-dimensional orifice defined by the inner surface of the conduit. See also via Figure 3K The structure shown has a two-dimensional hole defined by the surface shown.

[0585] 5.8 Other Notes

[0586] This patent document contains a portion of copyrighted material. Because it appears in the patent office's patent documents or records, the copyright holder does not object to any reproduction of this patent document or a copy of the patent disclosure, but otherwise retains all copyright rights.

[0587] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other value or intermediate value within the range are broadly included within the scope of this invention. The upper and lower limits of these intermediate ranges may be included independently within the intermediate range and within the scope of this invention, but are subject to any explicitly excluded boundaries within the range. When the range includes one or both of these boundaries, the range excluding one or both of those included boundaries is also included within the scope of this invention.

[0588] Furthermore, in cases where one or more values ​​described in the present invention are implemented as part of the present invention, it should be understood that such values ​​may be approximate unless otherwise stated, and such values ​​may be used to the extent permitted or required by the practical implementation of the technology for any suitable valid number of digits.

[0589] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of the techniques of this invention, a limited number of exemplary methods and materials are described herein.

[0590] When a particular material is deemed preferably used for constructing a component, an obvious alternative material with similar properties is used as its substitute. Furthermore, unless otherwise stated, any and all components described herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0591] It must be noted that, unless the context clearly specifies otherwise, the singular forms “a” and “the” as used herein and in the appended claims include their plural equivalents.

[0592] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein provide only disclosures prior to the filing date of this application. None of this document should be construed as an admission by prior invention that the present invention was not entitled to pre-existing technology in such publications. Furthermore, the publication dates provided may differ from the actual publication dates, and independent verification may be required.

[0593] The terms “comprising” and “including” should be interpreted as meaning that an element, component or step referenced in a non-exclusive manner may be presented, used or combined with other elements, components or steps not explicitly referenced.

[0594] The main headings used in the detailed description are included for the reader's convenience only and should not be used to limit the subject matter of the invention as found throughout the disclosure or claims. These headings should not be used to interpret the scope or limitation of the claims.

[0595] Although the invention has been described with reference to specific embodiments, it should be understood that these examples are merely illustrative of the principles and applications of the invention. In some instances, proper nouns, terms, and symbols may imply specific details not required for practicing the invention. For example, although the terms "first" and "second" may be used, they are not intended to indicate any order unless otherwise specified, but rather to distinguish different elements. Furthermore, although the process steps in a method may be described or illustrated in a certain order, this order is not necessary. Those skilled in the art will recognize that this order can be modified, and / or aspects of the order can be performed simultaneously or even concurrently.

[0596] Therefore, it should be understood that various modifications can be made to the exemplary instances and other arrangements can be designed without departing from the spirit and scope of the present invention.

[0597] 5.9 List of Reference Symbols

[0598] 1000 patients

[0599] 1100 bed partners

[0600] 3000 patient interface

[0601] 3100 sealing structure

[0602] 3105 sealing surface

[0603] 3110 laces

[0604] 3111 end

[0605] 3115 surrounding area

[0606] 3120 tubular structure

[0607] 3125 sealing sheet

[0608] 3130 thick part

[0609] 3135 thin section

[0610] 3140 hinge structure

[0611] 3145 Attachment

[0612] 3150 pieces

[0613] 3155 ribs

[0614] 3160 pieces

[0615] 3165 connection point

[0616] 3170 degrees

[0617] Area 3175

[0618] Area 3175A

[0619] Area 3175B

[0620] 3175C area

[0621] Area 3175D

[0622] Area 3175E

[0623] 3175F area

[0624] 3200 air chamber

[0625] 3210 surrounding area

[0626] 3220 boundary edge

[0627] 3300 structure

[0628] 3400 exhaust port

[0629] 3600 connection port

[0630] 3700 Forehead Brake

[0631] 3800 pad assembly

[0632] 3810 pad

[0633] 3810 foam pad

[0634] 3812 Flexible Support Clip

[0635] 3814 Second Clip

[0636] 3816 Mask Housing

[0637] 4000RPT device

[0638] 4170 air circuit

[0639] 5000 Humidifier

[0640] 6000 structure

[0641] Area 6005

[0642] Area 6005A

[0643] Area 6005B

[0644] 6005C area

[0645] 6005D area

[0646] Area 6005F

[0647] 6005G area.

Claims

1. A patient interface for sealingly delivering an airflow to an inlet of the patient's airway, including an inlet at least the patient's nostrils, under a continuous positive pressure relative to ambient atmospheric pressure, wherein the patient interface is configured to maintain a therapeutic pressure within a range of 3 cmH2O to 40 cmH2O above ambient atmospheric pressure throughout the patient's respiratory cycle during sleep, to improve sleep-disordered breathing, the patient interface comprising: A sealing structure for sealing the patient interface against the patient's face, the sealing structure comprising: A sealing surface configured to form a seal around the periphery of the inlet of the patient's airway; and A ring, the ring including the sealing structure folded inward from the outer periphery of the sealing structure and attached to a portion of the inner surface of the sealing structure such that the inner surface of the sealing structure is continuous around the ring, and the outer portion of the ring opposite the inner surface of the sealing structure includes a portion of the sealing surface; Positioning and stabilizing the structure to maintain a sealed contact between the sealing structure and the area surrounding the inlet of the patient's airway, while maintaining therapeutic pressure at the inlet of the patient's airway; An inflation chamber, which is pressurized during use at a pressure exceeding ambient pressure; and A gas flushing exhaust port is configured to allow exhaled CO2 from the patient to flow to the outside of the patient interface, thereby minimizing the rebreathing of the exhaled CO2. The ring is formed in a hollow interior that is in fluid communication with the pressure exceeding ambient pressure in the inflation chamber during use.

2. The patient interface according to claim 1 further includes a sealing sheet protruding toward the inner periphery of the sealing structure.

3. The patient interface of claim 2, wherein the sealing strip is configured to form a seal in a recess adjacent to the inner canthus of the patient for the sides of the nose above the nasal bone and adjacent to the sides of the nose above the maxilla.

4. The patient interface of claim 3, wherein the sealing strip is configured to avoid sealing against the nasal ala.

5. The patient interface of claim 1, wherein the portion of the sealing surface has increased flexibility relative to the remainder of the ring.

6. The patient interface of claim 1, wherein the portion of the sealing surface includes a wall section that is thinner than the remainder of the ring.

7. The patient interface of claim 1, wherein the portion of the sealing surface includes a wall section that is thicker than the remainder of the ring.

8. The patient interface of claim 1, wherein the sealing surface includes a friction-reducing region to reduce adhesion to the patient's face.

9. The patient interface according to claim 8, wherein the area of ​​reduced friction is a frosted surface.

10. The patient interface of claim 8, wherein the friction-reduced area is adapted to allow the side of the patient's nose to slide freely against the sealing surface.

11. The patient interface of claim 1, wherein the sealing surface defines an area of ​​the sealing structure suitable for contacting the patient's face.

12. The patient interface of claim 11, wherein the portion is part of the area of ​​the sealing structure adapted to contact the patient's face.

13. The patient interface according to claim 1, wherein the seal is continuous.

14. The patient interface of claim 1, wherein the ring is positioned to contact or be adjacent to the patient's nasal ala.

15. The patient interface of claim 14, wherein the ring is positioned such that the outer portion of the ring is adapted to contact the patient's nasal ala or be positioned next to the patient's nasal ala.

16. The patient interface of claim 15, wherein the outer portion of the ring is adapted to be positioned substantially parallel to the patient's nasal ala.

17. The patient interface of claim 1, further comprising a second ring, the second ring including a second portion of the sealing structure folded inward from the outer periphery of the sealing structure and attached to the inner surface of the sealing structure such that the inner surface of the sealing structure is continuous around the second ring, the outer portion of the second ring opposite the inner surface of the sealing structure including the second portion of the sealing surface.

18. The patient interface of claim 17, wherein the second ring is formed in a hollow interior in which, during use, it is in fluid communication with the pressure exceeding ambient pressure in the inflation chamber.

19. The patient interface of claim 17, wherein the ring or both the ring and the second ring comprise two open ends.

20. The patient interface of claim 17, wherein the ring or the ring and the second ring are adapted to prevent the sealing surface from being ejected when the patient interface is internally pressurized and adjusted by the patient.

21. The patient interface according to claim 1, further comprising: A sealing sheet, the sealing sheet protruding toward the inner periphery of the sealing structure; and The second ring includes a second portion of the sealing structure that is folded inward from the outer periphery of the sealing structure and attached to the inner surface of the sealing structure, such that the inner surface of the sealing structure is continuous around the second ring, and the outer portion of the second ring opposite to the inner surface of the sealing structure includes the second portion of the sealing surface. The sealing strip is configured to form a seal in a recess adjacent to the patient's inner canthus for the sides of the nose above the nasal bone and adjacent to the sides of the nose above the maxilla. The sealing strip is configured to avoid sealing the nostrils. The sealing surface includes friction-reducing areas to minimize adhesion to the patient's face. The ring, or both the ring and the second ring, includes a hollow interior adapted for fluid communication with the pressure exceeding ambient pressure. The ring, or both the ring and the second ring, includes two open ends.

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