Gas purge vent for patient interface

Abstract

A gas flush vent includes a housing having a first wall having one or more channels therethrough configured to be in fluid communication with a portion of a patient interface system exposed to a treatment pressure. The channels include respective first openings on the first surface of the first wall. The housing at least partially defines a second opening in communication with the ambient atmosphere. A diffusive material is located at least partially within the housing adjacent the first surface. A surface of the diffusing material facing the first surface is spaced apart from the first surface by a gap extending to provide fluid communication between all the first openings and between all the first openings and the second openings. The housing is configured such that air is prevented from flowing out of the housing at all regions directly opposite each of the first openings.

Description

[0001] This application is a divisional application of patent application No. 202210128752.0, filed on November 9, 2017, entitled "Gas Flushing Vent for Patient Interface". Patent application No. 202210128752.0 is a divisional application of patent application No. 201780079694.4, filed on November 9, 2017, entitled "Gas Flushing Vent for Patient Interface".

[0002] This application claims the benefit of U.S. Provisional Application No. 62 / 420,678, filed November 11, 2016, the entire contents of which are incorporated herein by reference. Background Technology 1.1 Technical Field This technology relates to one or more of the following: detection, diagnosis, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses.

[0003] 1.2 Description of relevant technologies 1.2.1 The Human Respiratory System and Its Disorders The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0004] 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 expelling carbon dioxide 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 *Physiology of the Respiratory System*, published in 2012 by John B. West, Lippincott Williams & Wilkins. Respiratory Physiology ( ), 9th edition.

[0005] There are a range of breathing disorders. Some disorders can be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

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

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

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. 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 (Berthon-Jones).

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

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

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

[0012] Chronic obstructive pulmonary disease (COPD) 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.

[0013] 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.

[0014] 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.

[0015] 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.

[0016] 1.2.2 Treatment Various treatments, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), and invasive ventilation (IV), have been used to treat one or more respiratory disorders.

[0017] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as an air splint and prevents upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. OSA treatment with CPAP can be voluntary, so patients may choose not to comply if they find the device used to provide such treatment uncomfortable, difficult to use, expensive, or unsightly.

[0018] 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 orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-malignant tumors (NMD), and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0019] 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.

[0020] 1.2.3 Treatment System These treatments can be provided by treatment systems or devices. Such systems and devices can also be used to diagnose conditions without treating them.

[0021] The treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0022] Another type of treatment system is the mandibular repositioning device.

[0023] 1.2.3.1 Patient Interface 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.

[0024] 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 configured to prevent water from flowing in from external high pressure, rather than maintaining air at a pressure higher than the environment inside.

[0025] 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.

[0026] 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.

[0027] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0028] 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.

[0029] Due to these challenges, some face shields suffer from one or more of the following problems: protrusion, unsightly appearance, high cost, mismatch, difficulty in use, and discomfort, especially when worn for extended periods or when the patient is unfamiliar with the system. Incorrectly sized face shields lead to decreased compliance, reduced comfort, and poorer 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 may be 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. This is especially true if the face shield is worn during sleep.

[0030] 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.

[0031] 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.

[0032] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0033] 1.2.3.1.1 Sealing Formation Structure Patient interfaces may include sealing structures. Because they come into direct contact with the patient's face, the shape and configuration of the sealing structure can directly affect the effectiveness and comfort of the patient interface.

[0034] The patient interface is characterized in part by the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils during use. Such a single element may be designed, for example, to cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0035] A sealing structure that works effectively in one area of ​​a patient's face may not be suitable for another, for example, due to the different shapes, structures, variations, and sensitive areas of the patient's face. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0036] Certain seal-forming structures 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 structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0037] One type of seal-forming structure extends around the periphery of a patient interface and, when force is applied to the patient interface while the seal-forming structure engages with the patient's facial face, it seals the patient's face. The seal-forming structure may include an air- or fluid-filled buffer, or a molded or shaped surface of an elastic sealing element made of an elastomer (e.g., rubber). With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the surface, and additional force will be required to force the patient interface against the face to achieve a seal.

[0038] Another type of seal-forming structure 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 within the mask. Similar to the previous type of seal-forming structure, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or bend during use, leading to leakage.

[0039] Another type of sealing structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0040] Another form of sealing can be achieved using adhesives. Some patients may find it inconvenient to constantly apply and remove adhesives from their face.

[0041] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785.

[0042] 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.

[0043] 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 TMLIBERTY™ Full Face Mask. The following patent application, assigned to ResMed Ltd., describes an example of a nose pillow mask: International Patent Application WO2004 / 073,778 (which describes a ResMed Ltd. SWIFT...). 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).

[0044] 1.2.3.1.2 Positioning and Stabilization The sealing structure of the patient interface used in positive air pressure therapy is subjected to the corresponding force of air pressure that could disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain it in a sealed relationship with the appropriate part of the face.

[0045] 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.

[0046] 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.

[0047] 1.2.3.2 Respiratory Pressure Therapy (RPT) Device Respiratory pressure therapy (RPT) devices can be used to deliver one or more of the many treatments described above, such as by generating an airflow for delivery to the airway inlet. The airflow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0048] 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.

[0049] One example of a specific requirement for certain RPT devices is noise.

[0050] 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).

[0051]

[0052] 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.

[0053] The ResMed Elisée™ 150 and ResMed VS III™ ventilators provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients to treat a variety of conditions. These ventilators offer volumetric and pressure-based ventilation modes with single-channel or dual-channel circuits. RPT devices typically include a pressure generator, such as an electric blower or 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 the one described above.

[0054] 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.

[0055] 1.2.3.3 Humidifier Delivering an unhumidified airflow can lead to airway dryness. Using a humidifier with an RPT device and patient interface produces humidified gas, minimizing dryness of the nasal mucosa and increasing patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air.

[0056] A range of artificial humidification devices and systems are known, however they may not meet the specific requirements of medical humidifiers.

[0057] 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.

[0058] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers provide insufficient humidification, while others may be difficult or inconvenient for patients to use.

[0059] 1.2.3.4 Ventilation port technology Some forms of patient interface systems may include ventilation ports to allow the flushing of exhaled carbon dioxide. Ventilation ports 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.

[0060] Ventilation vents may include orifices through which air can flow when a mask is used. 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.

[0061] 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.

[0062] The noise level of the existing face mask (ISO17510-2:2007, pressure of 10 cmH2O at 1m).

[0063] ( (Measured at 10 cmH2O using the test method specified in ISO 3744 in CPAP mode, for a single sample only) The sound pressure levels of various objects are shown below. Summary of the Invention 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.

[0064] The first aspect of this technology relates to devices for diagnosing, improving, treating, or preventing respiratory disorders.

[0065] Another aspect of this technology relates to methods for diagnosing, improving, treating, or preventing respiratory disorders.

[0066] One aspect of this technology in certain forms is used to provide methods and / or devices for improving patient compliance with respiratory therapy.

[0067] One aspect of the technology includes a gas flushing vent for a patient interface system, the gas flushing vent comprising: a housing including a first wall having one or more channels penetrating the first wall, the one or more channels being configured to be in fluid communication with a portion of the patient interface system configured to be exposed to therapeutic pressure, the housing at least partially defining a second opening in communication with the ambient atmosphere; and a diffuse material at least partially located within the housing.

[0068] One aspect of this technology includes a gas flushing vent for a patient interface system, configured to maintain a treatment pressure within a range of about 4 cmH2O to about 30 cmH2O above ambient pressure during use throughout the patient's respiratory cycle, while the patient is sleeping, to improve breathing or sleep apnea conditions. The gas flushing vent includes: a housing comprising a first wall having one or more channels extending through the first wall, the channels configured to be in fluid communication with a portion of the patient interface system configured to be exposed to the treatment pressure, the channels including corresponding first openings on a first surface of the first wall, the housing at least partially defining a second opening in communication with the ambient atmosphere; and a diffusing material at least partially located within the housing adjacent to the first surface, the surface of the diffusing material facing the first surface spaced apart by a gap extending to provide fluid communication between all the first openings and between all the first openings and the second opening; wherein the housing is configured to prevent air from escaping from the housing at all areas directly opposite each of the first openings.

[0069] In the example, (a) the housing further includes a third opening communicating with the ambient atmosphere, wherein the third opening does not overlap with the outlet region of any channel projecting along the central axis of the respective channel, and is positioned such that at least part of the diffuse material is located between each first and third opening; (b) the third opening is oriented such that the central axis passing through the third opening is angled relative to the central axis of any channel; (c) the third opening is sized such that complete blockage of the third opening does not significantly reduce the airflow through the gas flushing vent when a portion of the patient interface is exposed to treatment pressure; (d) the airflow through the gas flushing vent does not (e) The third opening is one of several third openings; (f) The third opening is configured to remove water; (g) The second opening includes several second openings; (h) At least one of one or more channels is sized such that when a portion of the patient interface is exposed to treatment pressure, at least a portion of the air leaving the corresponding first opening permeates into the diffuser material; (i) The gas flushing vent is configured to allow a portion of the air permeated into the diffuser material to leave the diffuser material and re-enter the gap before flowing out from the second opening; (j) The gas flushing vent is configured to allow a portion of the air leaving the corresponding first opening to leave the diffuser material and re-enter the gap before flowing out from the second opening; (k) A portion of the air in the opening permeates through the surface and exits the diffuser material; (l) When the air exits the second opening, a noise of no more than 28 dB(A) is generated due to a portion of the patient interface being exposed to treatment pressure; (m) The diffuser material comprises uncompressed fibers; (n) The diffuser material comprises a hygroscopic material; (o) The hygroscopic material is a sintered plastic; (p) The diffuser material comprises a hydrophobic material; (q) The diffuser material has antibacterial properties; (r) The first wall is fixed within the housing in a non-releasable manner; (s) The gap is at least partially defined by the first wall from the first opening to the second opening; (v) The gap extends from the position opposite the first opening to... A portion of the diffuse material closest to the second opening is formed on the surface; (t) the gap narrows radially; (u) the gap gradually narrows radially outward; (v) the surface of the diffuse material is parallel to the first surface; (x) the surface of the diffuse material is inclined to the first surface; (z) a portion of the housing is removable to allow replacement of the diffuse material; (aa) the dimensions of the second opening and the gap are configured such that most of the pressure drops before the air leaves the channel as air flows through the channel, the gap, and the second opening; and / or (bb) the gas flushing vent includes a separate device for engaging with a patient interface or air circuit.

[0070] Another aspect of the technology includes a system for treating a patient’s respiratory disorder, the system comprising a respiratory pressure therapy device; a humidifier; an air circuit; and a patient interface, wherein at least one of the air circuit and the patient interface includes a gas flushing vent according to any of the foregoing aspects or examples.

[0071] Of course, the parts of each aspect can form sub-aspects of this technology. In addition, the sub-aspects and / or the aspects within the aspects can be combined in any way and also constitute other aspects or sub-aspects of the present invention.

[0072] Other features of the invention will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims. Attached Figure Description This technology is illustrated in the accompanying drawings by way of example rather than limitation, wherein the same reference numerals denote similar elements, including: 3.1 Treatment System Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 in a nasal pillow manner receives a positive pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient sleeps in a supine sleeping position.

[0073] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0074] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying sleeping position.

[0075] 3.2 Respiratory System and Facial Anatomy Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0076] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, external nasal cartilage, greater alaural cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, pharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0077] Figure 2CIt 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 groove, and corners of the mouth. It also indicates the directions of up, down, radially inward, and radially outward.

[0078] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal septum, upper lip, lower lip, supramental point, bridge of the nose, apex of the nostrils, supraauricular base, and subauricular base. It also indicates the vertical and horizontal directions.

[0079] Figure 2E This is another side view of the head. It indicates the approximate location of the Frankfurt plane and the nasolabial angle. The coronal plane is also indicated.

[0080] 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.

[0081] Figure 2G A side view showing the surface features of the nose.

[0082] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0083] 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.

[0084] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal turbinate bones, as well as the maxilla and mandible, are also indicated.

[0085] Figure 2K A side view of the skull is shown, showing the surface outline of the head and several muscles. 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 indicated. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0086] Figure 2L The frontal lateral view of the nose is shown.

[0087] 3.3 Patient Interface Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0088] 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.

[0089] 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.

[0090] 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.

[0091] 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.

[0092] Figure 3F 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 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0093] Figure 3G A buffer for a face mask comprising two pillows is shown. The outer surface of the buffer is indicated. The edge of the surface is indicated. The dome-shaped and saddle-shaped areas are indicated.

[0094] Figure 3H The buffer used for the face mask is shown. The outer surface of the buffer is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle-shaped areas and one dome-shaped area are indicated.

[0095] Figure 3I A surface with a one-dimensional hole is shown. The planar curve shown forms the boundary of the one-dimensional hole.

[0096] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface constraint shown. Figure 3I Two-dimensional holes in the structure.

[0097] 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 3IThe surface of a two-dimensional hole in a structure.

[0098] Figure 3L A face mask with an inflatable airbag as a buffer is shown.

[0099] Figure 3M It shows crossing Figure 3L The cross-section of the mask is shown, along with the inner surface of the airbag. The inner surface restricts the two-dimensional perforations in the mask.

[0100] Figure 3N It shows crossing Figure 3L The cross-section of the mask. The inner surface is also indicated.

[0101] Figure 3O The left-hand rule is shown.

[0102] Figure 3P The right-hand rule is shown.

[0103] Figure 3Q The left ear is shown, including the left ear spiral.

[0104] Figure 3R The right ear is shown, including the right ear spiral.

[0105] Figure 3S A right-handed spiral is shown.

[0106] Figure 3T A view of the face mask is shown, including torque markers for spatial curves defined by the edges of sealing membranes in different areas of the face mask.

[0107] 3.4 Ventilation port Figure 4A An air vent of one form according to the present technology is shown.

[0108] Figure 4B Another form of ventilation port according to this technology is shown.

[0109] Figure 4C Another form of ventilation port according to this technology is shown.

[0110] Figure 4D Another form of ventilation port according to this technology is shown.

[0111] Figure 4E Another form of ventilation port according to this technology is shown.

[0112] Figure 4F Another form of ventilation port according to this technology is shown.

[0113] Figure 4G Another form of ventilation port according to this technology is shown.

[0114] Figure 4H It shows Figure 4G The top of the ventilation opening has been removed to reveal the internal structure.

[0115] Figure 4I It shows Figure 4H The cross-section, but including the top.

[0116] Figure 4J It shows the inclusion of additional components. Figure 4H The first alternative to the cross-section.

[0117] Figure 4K An alternative form including additional components is shown. Figure 4H The second alternative to the cross-section. Detailed Implementation Before describing the present technology in further detail, it should be understood that the present invention is not limited to the specific instances described herein, and the specific instances 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 instances described herein only and is not intended to be limiting.

[0118] 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.

[0119] 4.1 Treatment 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.

[0120] In some embodiments of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0121] In some embodiments of this technology, mouth breathing is defined, restricted, or prevented.

[0122] 4.2 Treatment System In one form, the technology includes a device or apparatus for treating respiratory disorders. The device or apparatus 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.

[0123] 4.3 Patient Interface According to one aspect of the present technology, a non-invasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air exchange 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 the supply of positive pressure air to the airway.

[0124] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0125] 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.

[0126] 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.

[0127] 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.

[0128] 4.3.1 Sealing Formation Structure In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual sealing surface—can vary daily throughout a given treatment course depending on the patient and a range of factors, including, for example, the placement of the patient's interface on the face, the tension of the positioning and stabilizing structures, and the shape of the patient's face.

[0129] In one embodiment, the target sealing area is located on the outer surface of the sealing structure 3100.

[0130] In some forms of this technology, the sealing structure 3100 is constructed from a biocompatible material, such as silicone rubber.

[0131] The sealing structure 3100 according to this technology can be constructed from a soft, flexible, and elastic material such as silicone.

[0132] In some forms of this technology, a system is provided that includes more than one sealing formation 3100, each configured to correspond to a different size and / or shape range. For example, the system may include one form of sealing formation 3100 suitable for large-sized heads but not for small-sized heads, and another form of sealing formation 3100 suitable for small-sized heads but not for large-sized heads.

[0133] 4.3.1.1 Sealing Mechanism In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange responds rapidly to the positive system pressure within the inflation chamber 3200, acting on the underside of the inflation chamber to create a tight seal with the face. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0134] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the circumference of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the boundary edges of the sealing flange and the inflation chamber 3200 and extends around at least a portion of the circumference. The support flange is or includes spring-like elements and functions to support the sealing flange against buckling during use.

[0135] In one form, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or gasket seal portion is constructed and arranged in a compressed state, for example, due to elastic tension in the positioning and stabilizing structure.

[0136] In one form, the sealing structure includes a tension section. During use, the tension section, for example, is maintained under tension through an adjacent area of ​​the sealing flange.

[0137] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0138] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or bonding surface.

[0139] 4.3.1.2 Nasal bridge or nasal ridge area In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the bridge or ridge of the nose of the patient's face during use.

[0140] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the bridge or ridge of the nose of a patient's face during use.

[0141] 4.3.1.3 Upper lip area In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face during use.

[0142] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip region of a patient's face during use.

[0143] 4.3.1.4 Chin region In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the chin region of the patient's face during use.

[0144] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the chin area of ​​a patient's face during use.

[0145] 4.3.1.5 Forehead area In one form, the sealing structure forms a seal on the forehead area of ​​the patient's face during use. In this form, the inflatable chamber can cover the eyes during use.

[0146] 4.3.1.6 Nasal pillow In one form, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is configured and arranged to form a seal with the corresponding nostril of the patient's nose.

[0147] A nasal pillow according to one aspect of the present invention includes: a truncated cone forming a seal on at least a portion of the underside of the patient's nose, a handle, a flexible region on the underside of the truncated cone, and a region connecting the truncated cone to the handle. Additionally, the structure to which the nasal pillow of the present invention is connected includes a flexible region adjacent to a base of the handle. The flexible region can work synergistically to facilitate a universal joint structure that accommodates the displacement and angle of the truncated cone relative to the structure to which the nasal pillow is connected. For example, the truncated cone can be axially displaced toward the structure connected to the handle.

[0148] 4.3.2 Inflation Chamber In the sealed area formed during use, the air chamber 3200 has a perimeter whose shape complements the surface contour of a typical human face. During use, the boundary edges of the air chamber 3200 are in close proximity to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 can extend along the entire perimeter of the air chamber 3200 during use. In some forms, both the air chamber 3200 and the sealing structure 3100 are composed of a single homogeneous material.

[0149] In some forms of this technology, the inflation chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the inflation chamber. This form tends to be less obtrusive and / or more comfortable for the wearer, which can improve treatment adherence.

[0150] In some forms of this technology, the air chamber 3200 is constructed of a transparent material (e.g., transparent polycarbonate). Using transparent materials reduces patient interface inconvenience and helps improve treatment adherence. Transparent materials also help clinicians observe how the patient interface is positioned and functions.

[0151] In some forms of this technology, the air chamber 3200 is constructed of a translucent material. Using a translucent material reduces inconvenience to the patient interface and helps improve treatment adherence.

[0152] 4.3.3 Positioning and Stabilization Structure 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.

[0153] In one configuration, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the effect of positive pressure opening the face in the inflation chamber 3200.

[0154] In one configuration, the positioning and stabilizing structure 3300 provides a holding force to overcome the effects of gravity on the patient interface 3000.

[0155] In one form, the positioning and stabilizing structure 3300 provides a retaining force as a safety boundary to overcome the potential effects of destructive forces (such as those from tube resistance or accidental interference from the use of the patient interface) on the patient interface 3000.

[0156] 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 instance, 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.

[0157] 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 sleeping in a supine position with the back of the patient's head resting on the pillow.

[0158] 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 sleeping in a side-lying position with the patient's head side area resting on the pillow.

[0159] In one form of this technology, the positioning and stabilizing structure 3300 has a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible or loose band. The decoupling portion is constructed and arranged such that when the patient's head is resting on the pillow, the presence of the decoupling portion prevents forces at the rear from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0160] In one form of this technology, the positioning and stabilizing structure 3300 includes a band constructed of 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 band. In another form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0161] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For instance, the strap may be configured in use to withstand tensile forces and guide forces to bring the sealing structure into sealed contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0162] In one form of this technology, the positioning and stabilizing structure includes a first frenulum, which is constructed and arranged such that, in use, at least a portion of its lower edge passes over to the supraaural base of the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0163] In one form of this technology applicable to a single nasal mask or a full-face mask, the positioning and stabilizing structure includes a second strap, which is configured and arranged such that, in use, at least a portion of its upper edge passes under the patient's head to the subauricular base and covers or is located under the occipital bone of the patient's head.

[0164] In one form of this technology applicable to single nose masks or full-face masks, the positioning and stabilizing structure includes a third strap, which is configured and arranged such that the first and second straps are interconnected to reduce the tendency of the first and second straps to move apart from each other.

[0165] 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.

[0166] In some forms of this technology, the positioning and stabilizing structure 3300 includes a breathable strip configured to allow the transport of moist vapor through the strip.

[0167] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, and another form of positioning and stabilizing structure suitable for small-sized heads but not for large-sized heads.

[0168] 4.3.4 Ventilation port In one form, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0169] In some configurations, the ventilation port 3400 is configured to allow continuous ventilation from within the inflation chamber 3200 to the environment, while the pressure within the inflation chamber is positive relative to the environment. The ventilation port 3400 is configured such that the airflow rate is sufficient to reduce the rebreathing of exhaled CO2 from the patient, while maintaining the therapeutic pressure of the inflation chamber in use.

[0170] The ventilation port 3400 can take various forms. In one form, the ventilation 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. The size of each hole can be between 0.5 mm and 1 mm, preferably between 0.6 mm and 0.9 mm, more preferably between 0.7 mm and 0.8 mm. Although the holes are generally formed with circular openings, other shapes are also possible. Some smaller holes can be replaced by one or more larger holes. Some larger holes can be in the form of slits.

[0171] The vent 3400 may be located on or integrated into the inflation chamber 3200 or within the bend 3600. Alternatively, the vent 3400 may be formed separately as a decoupled structure, for example, it may be configured as a pivot of the air circuit 4170 or the portion between the air circuit 4170 and the inflation chamber 3200.

[0172] Figure 4A One implementation of the vent 3400 is shown (e.g., gas flushing vent). Figure 4A The cross-section shown is a cross-section passing through channel 3402, wall 3404, diffuser material 3406, and housing 3408, each of which surrounds the central airway 3410. Airway 3410 may be part of the inlet of inflation chamber 3200 (e.g., part of a decoupling structure) or may be part of air circuit 4170. The illustrated cross-section includes some symmetry about the central airway 3410, but symmetry is not required.

[0173] The diffuse material 3406 is separated from the wall 3404 by a gap 3412, thereby providing a channel with uninterrupted fluid communication between 3402 and the opening 3416. This is provided by positioning the diffuse material at least partially within the housing, such that the surface 3414 of the diffuse material 3406 faces the surface of the opening 3420. The surface 3414 of the diffuse material is a substantially flat surface and is spaced apart from the surface of the opening 3420 by the gap 3412. This configuration allows the gap to extend to provide fluid communication between all openings 3420 and between all openings 3420 and the opening 3416.

[0174] Opening 3416 provides communication with the ambient atmosphere. The dimensions of the gap should allow for the removal of any dust accumulated within the gap and for any accumulated water to dry out. Therefore, the depth of gap 3412 can be between 1 mm and 3 mm, preferably between 1.5 mm and 2.5 mm, and even more preferably, approximately 2 mm. As will be discussed later herein, this arrangement allows at least some of the pressurized air (e.g., a jet or pressure wave) exiting channel 3402 to bridge gap 3412 and enter diffuser material 3406 during standard operation of the patient interface. Once the airflow enters the diffuser material, the properties of the material force the airflow to flow along a curved path. Even if there is a path with lower resistance through gap 3412, air can enter diffuser material 3406 if an air jet, possibly at or near the speed of sound, applies sufficient momentum to the air so that at least some molecules enter the diffuser material.

[0175] The properties of the diffuser material 3412, such as its thickness or density, and the size of the opening 3424, are chosen such that the effect of the opening 3424 on the overall airflow is negligible. Furthermore, the second wall 3428 is directly opposite the channel 3402 relative to the diffuser material 3406. Therefore, the housing 3408 is essentially closed for airflow on the opposite side. Because of this, the airflow entering the diffuser material 3406 is forced to eventually return to the gap 3412 and exit into the ambient air via the opening 3416. The curved path imposed on the airflow by the aforementioned vent configuration significantly reduces the jetting effect and / or noise associated with the vent. Alternatively or additionally, because the diffuser material 3406 defines at least one side of the gap 3412, any sound waves propagating through this gap are able to extend into the diffuser material 3406 and reduce the sound level, even with little or no clear airflow through the diffuser material 3406 itself.

[0176] As shown, the gap 3412 extends along the surface 3414 of the diffuse material 3406 all the way to the opening 3416, but the gap 3412 does not need to extend along its entire length. For example, there may be no gap at portion 3418 (e.g., inside the channel 3402 closest to the air passage 3410, radially inward in the illustrated embodiment). Other configurations of the gap 3412 may also be provided, which provide an uninterrupted path from the channel 3402 to the channel 3416.

[0177] The gap 3412 improves the performance characteristics of the vent 3400 compared to a vent without a gap. For example, some materials suitable for the diffuser material 3406 may be difficult to manufacture with consistent density and permeability. This can lead to undesirable variations in the flushing airflow at vents for different patient interfaces. The introduction of the gap provides a permanent escape path and results in a more consistent and / or predictable flushing flow. The gap offers another advantage when airflow through the diffuser material 3406 is reduced or blocked for any reason, such as if the material 3406 has become wet. In this case, the gap 3412 provides an escape path for air to reach the ambient atmosphere.

[0178] Wall 3404 separates the diffuse material 3406 from the interior of the patient interface 3000, which is exposed to therapeutic pressure during use. Channel 3402 is shown as passing through wall 3404 and including a corresponding opening 3420 adjacent to and facing the diffuse material 3406. Channels 3402 can be of any number and any geometric configuration providing the desired flow characteristics of the vent 3400. For example, channels can be cylindrical channels, truncated conical channels, and / or any other three-dimensional shape (such as a slot) that provides the desired performance characteristics of the vent 3400. Although in Figure 4AIn this configuration, the channel is a truncated cone with a tapering downward opening toward the diffuser material, but this is not always the case, and the tapering downward opening of the truncated cone may point in the opposite direction. Any or all of these configurations can provide fluid communication with the interior of the patient interface 3000, which is configured to be exposed to treatment pressure. A single channel 3402 or multiple channels may be provided, but providing multiple channels may reduce any audible noise generated. The channel 3402 may be a passive or part of a valve system (not shown) that regulates airflow through the channel based on conditions such as treatment pressure. The dimensions of the opening 3420 and / or the channel 3402 are determined, and the opening 3420 and the diffuser material 3406 are oriented such that when the interior of the patient interface 3000 is exposed to treatment pressure, air exiting the opening 3420 may impinge on the diffuser material 3406 at surface 3414. Air exiting the opening 3420 may also impinge when the interior is exposed to pressures below the treatment pressure. With this configuration, when the internal portion of the patient interface 3000 is exposed to treatment pressure, at least a portion of the air leaving the opening 3420 is permeable to the diffuser material 3406 and then exits from the surface 3414 before leaving the vent via the opening 3416. Any portion of the air permeates the diffuser material 3406 but does not exit the surface 3414, and may exit elsewhere due to leakage in the housing 3408. This flow configuration can result in a more tortuous overall flow path for gas exiting the vent 3400, thus making it more likely to suppress or eliminate generated noise. If the velocity is low enough and the porosity of the surface 3414 prevents air permeation due to surface effects, air may impinge but not permeate. In this scenario, the diffuser material 3406 can still reduce the jetting effect and reduce noise by allowing sound waves to propagate into and dissipate within the diffuser material 3406.

[0179] When air passes through the material, the diffuser 3406 can cause air diffusion, which can absorb energy and / or reduce air velocity. Reduced flow velocity decreases associated noise, typically caused by turbulent flow or air jets colliding with hard surfaces. The diffuser 3406 can be a fibrous material similar to those used in filter media (e.g., uncompressed fibers such as polyester) or open-cell foam. Any material that at least partially allows airflow and provides a curved path for the air flowing through the material can be used for the diffuser 3406. The diffuser can be a hygroscopic material, such as sintered plastic. The diffuser can also be hydrophobic and can be processed to have antimicrobial properties. One or more of these configurations may help remove moisture, which can be beneficial during the cleaning process.

[0180] The housing 3408 can have any shape that helps hold the diffuse material 3406 in place while also providing the desired flow characteristics for the vent 3400. The housing 3408 is illustrated as including a wall configuration that prevents air from exiting the housing in all areas directly opposite each of the openings 3420. The housing 3408 may include all structural components surrounding the diffuse material 3406, such as walls 3404 and 3428. A centerline 3430 is shown along the central axis of each of the channels 3402 and extends to the second wall 3428. If the channels are sufficiently long relative to the inlet flow conditions, a fully extended flow will occur, and arrow 3422 will be an approximation of the flow vectors passing through and leaving the channels 3402. The turbulent nature of fluid flow can cause actual flow divergence and dissipation as the airflow moves away from the channels 3402. However, vectors (e.g., amplitude and direction) can be used to characterize the flow at a given point. If these vectors extend, they will eventually intersect a portion of the housing 3408 without openings. However, this is not simply a flow vector that typically extends along the central axis of its respective opening, which would encounter a solid wall if these vectors extended in the flow direction. If the cross-sectional area of ​​each of the openings 3420 extends along the corresponding centerline 3430, the image of that area would extend over the solid portion of the wall 3428 rather than over the opening in the wall 3428. Therefore, no opening in the housing 3408 or vent 3400 (e.g., the second opening 3424) is aligned with the outlet vector or overlaps with the extended area from any of the channels 3402, and air leaving the channel 3402 cannot exit the vent 3400 from a portion of the second wall 3428 directly opposite the channel 3402. Instead, the outlet 3416 extends along an angle relative to the airflow vector of the channel 3402. This angle can be acute, but in some instances it is a right angle (e.g., perpendicular to the outlet vector) or even an obtuse angle. This configuration increases the possibility that air leaving channel 3402 will exit vent 3400 via opening 3416 through diffuser material 3406 along a curved path. As previously mentioned, outlet 3416 may be defined by one or more of the following: the wall of housing 3408, the surface of diffuser material, or the surface of another component. Outlet 3416 can be directed in any direction as long as it releases air into the environment along a path that does not pass through diffuser material 3406. In an alternative instance, the airflow exiting outlet 3416 may be parallel to arrow 3422, but may be deviated from it.

[0181] As shown, housing 3408 partially defines opening 3416, and wall 3404 also partially defines opening 3416, but opening 3416 may be completely defined by housing 3408 or not defined at all by housing 3408. For example, in the latter case, opening 3416 may be defined by a component rather than housing 3408. Any configuration and location of opening 3416, providing a suitable flow path, including gap 3412, can be utilized. As shown, opening 3416 is an annular gap surrounding the periphery of vent 3400, but opening 3416 can be any number of openings. For example, it may be desirable to divide opening 3416 into several openings to increase the stability of the resulting opening. As shown, opening 3416 can be described as an outlet directly to the environment, but opening 3416 may be a less direct or more curved path to the environment. For example, there may be additional structural elements that create a flow path containing one or more loops before exiting the path to the environment. Furthermore, compared to the illustration, the opening 3416 can be in a different direction relative to the gap 3412 or wall 3404. As shown, the flow path through the opening 3416 is substantially perpendicular to the channel 3402 and / or arrow 3422, but the opening can be at other angles or directions. For example, the flow path through the opening can be at an obtuse or acute angle to the channel 3402, or it can be parallel to and offset from the channel 3402.

[0182] The housing 3408 may also include an opening 3424 that is not aligned with the channel 3402. The opening 3424 is shown with a centerline 3432 on its central axis to visually clarify its orientation. The centerline 3430 of the channel 3402 is not aligned with the centerline 3432 of the opening 3424. Optionally, openings 3424 (0, 1, or more) may be included to allow for water removal after cleaning the vent 3400. The openings 3424 may allow water to vibrate out of the vent 3400 and / or allow water to evaporate and exit the vent 3400 more likely, where both vibration and evaporation contribute to drying the vent 3400. If openings 3424 are included, preferably, their position and size are configured in conjunction with the diffuser material 3406, the opening 3416, and the gap 3412 such that substantially no air leaves the openings 3424 when therapeutic pressure is applied to the patient interface 3000. To determine the outflow from opening 3424, pressure can be applied to the patient interface 3000 and the flow rate through the ventilation port 3400 can be measured. Opening 3424 can then be completely blocked and the flow rate measured again. If the flow rate decreases by less than a predetermined percentage, the airflow through the ventilation port 3400 is substantially not reduced. Preferably, the flow rate decrease is no more than 5%, more preferably no more than 3%. In practice, blocking opening 3424 should not cause a change in the flow rate through the ventilation port 3400. The ventilation port 3400 is designed such that completely blocking opening 3424 will substantially not change the flow rate through the ventilation port 3400, and even if the diffuser material 3406 is completely blocked due to the accumulation of water or mucus, the ventilation port 3400 should provide adequate gas flushing.

[0183] An opening 3424 may be formed in a region adjacent to one side of the diffuser material 3406, opposite the side facing the opening 3424. However, the size and location of the opening 3424 can vary. The opening 3424 can serve at least two purposes—allowing for cleaning and drying the vent. First, the opening 3424 allows a user to clean the diffuser material 3406 by placing the entire vent 3400 under running water. For effective cleaning, the opening 3424 is preferably large enough to allow liquid water (e.g., droplets) to enter the housing. Second, the opening 3424 allows for the removal of accumulated liquid (e.g., sludge, water, etc.) after cleaning or unintentionally accumulating during use of the vent. The size of each individual opening 3424 relates to the ability to allow liquids such as water to enter and exit the vent. The combined size of all openings determines the washing and drying efficiency of the vent. 20 mm 2 and 80 mm 2 The combined area is considered to allow for thorough cleaning and drying. In some instances, the total opening area is preferably 30 mm. 2 and 60 mm2 Between, or even more preferably at 50 mm 2 The location of the opening may also be important. Preferably, opening 3424 is spaced apart from and at least partially opposite to opening 3416 relative to the diffuse material 3406. This provides a path for water or liquid flow between opening 3416 and opening 3424, improving the ability to clean and dry the diffuse material 3406. At least in Figure 4A In the embodiment shown, water can be removed at least through the second opening 3424 by shaking or applying centripetal force to the vent 3400.

[0184] The housing 3408 may contain the diffuse material 3406 by any suitable method. For example, the housing 3408 and the diffuse material 3406 may be bonded together (e.g., glued or melted together) or mechanically fixed (e.g., by friction, interference, braking, etc.).

[0185] The housing 3408 can be a single integral piece or multiple pieces joined together to form a single piece. The wall 3404 can be permanently attached to the housing 3408 or integrally formed with the housing 3408. The housing can be attached to the vent 3400 in a non-releasable manner, an attachment not intended to be removed without damage. Non-releasable attachments can include adhesive, ultrasonic welding, hot ironing, one-time snap-fit ​​(e.g., snap-fit ​​designed to break upon separation), initially formed as a single piece, etc. Several benefits can be achieved if the housing 3408 is formed such that the housing 3408 and / or the diffuser 3406 cannot be removed. For example, if the housing 3408 and / or the diffuser 3406 cannot be removed, incorrect user installation or accidental detachment of the vent can be prevented.

[0186] Figure 4B Another configuration of the ventilation port 3400 is shown. (Compared to...) Figure 4A The relevant descriptions of the reference figures also apply here, so they will not be repeated. This configuration of the 3400 ventilation port is similar to... Figure 4A The configuration shown is different except that the air passage 3410 is omitted. Therefore, the gap 3412 extends from one side of the air vent 3400 to the other side.

[0187] Figure 4C Another configuration of the ventilation port 3400 is shown. (Compared to...) Figure 4A The descriptions related to the reference figures also apply here, and therefore will not be repeated. Here, the air passage 3410 is omitted, and instead, component 3426 is shown, which can fix the diffuse material 3406 and / or the housing 3408.

[0188] Figure 4DAnother configuration of the ventilation port 3400 is shown. (Compared to...) Figure 4A The descriptions related to the reference figures also apply here, so they will not be repeated. This figure and... Figure 4A The difference lies in the location of the opening 3424. The figure also shows that the opening 3416 can be a continuous opening surrounding the periphery of the ventilation port 3400. The opening 3424 can also be continuous, but preferably it is discontinuous with each other and / or discontinuous with the opening 3416.

[0189] Figure 4E Another configuration of the ventilation port 3400 is shown. (Compared to...) Figure 4A The description related to the reference figures also applies here, and therefore will not be repeated. In this configuration, channel 3402 communicates with and is arranged around air channel 3410, causing air vent 3400 to be connected to... Figures 4A-4D Compared to a planar structure, it has an overall ring structure. In other words, Figures 4A-4D The channel 3402 is located in a wall 3404 that is planar or near-planar, while Figure 4E The wall 3404 is cylindrical, and the gas leaving the vent 3400 leaves along the cylindrical axis indicated by the dashed line.

[0190] Figure 4F Another configuration of the ventilation port 3400 is shown. (Compared to...) Figure 4A The descriptions related to the reference figures also apply here, so they will not be repeated. Figure 4F and Figure 4E Similar, except in Figure 4F The diffuse material 3406 has openings 3416 at both ends, but in Figure 4E The opening 3416 is provided only at one end.

[0191] exist Figures 4A-4F In each of these diagrams, the arrows shown through the diffuser 3406 represent a conceptual diagram of airflow through the diffuser 3406 and may not represent actual airflow through the diffuser 3406. Typically, each of these arrows illustrates a concept of air leaving the channel 3402, entering the diffuser 3406 via the surface 3414, leaving the diffuser 3406 via the surface 3414, flowing through the gap 3412, and then flowing into the environment via the opening 3416.

[0192] Figure 4G-Figure 4I Another configuration of the ventilation port 3400 is shown. (Compared to...) Figure 4A The descriptions related to the reference figures also apply here, and therefore will not be repeated unless otherwise stated. Figure 4G An example of a ventilation port 3400 is shown in perspective, wherein the ventilation port 3400 is an insertable and / or removable component. Figure 4H This is a top view, in which the top cover 3440 is omitted, making the internal structure visible. Figure 4I yes Figure 4H The cross-sectional view is shown, but the top cover is included. This configuration of the vent 3400 is similar to... Figure 4B The configuration shown omits air passage 3410 (but it can be included if needed). Figure 4I The most visible part of the support 3434 is the contact surface 3414, which supports the diffuse material 3406. For example... Figure 4H and Figure 4I As shown, support 3434 is depicted as a continuous wall that bisects gap 3412, extending uninterruptedly from one side to the other. However, support 3434 need not be continuous and can be formed by one or more discontinuous supports (one or more gaps can be provided in support 3434).

[0193] Another difference is the location of the opening 3416. The opening 3416 is offset away from the surface including the opening 3420, rather than being substantially in a straight line with the gap 3412. This results in the second portion 3412A of the gap 3412 surrounding the periphery of the diffuse material 3406. With this arrangement, air can flow into the surface 3414 and out of the side surface 3436 of the diffuse material 3406 before flowing out of the opening 3416. Air can also flow through the gap 3412 and the second portion 3412A without passing through the diffuse material 3406. Due to the chaotic and unpredictable nature of individual molecular flows, the actual airflow can be a combination of two flow paths. However, by providing two flow paths, the vent 3400 can provide sufficient flow even if the diffuse material 3406 is blocked.

[0194] Figure 4G and Figure 4I A groove 3438 is shown around the perimeter of the vent 3400. This groove allows the vent 3400 to remain within a mating hole, preferably in a replaceable manner. For example, if the hole is made of a relatively flexible material (such as silicone), the vent 3400 can be easily removed for cleaning or replacement in a simple manner.

[0195] Figure 4J and Figure 4K It shows something similar to Figure 4I In that respect, but a deflector 3442 was added. Figure 4J In the diagram, deflector 3442 is shown as a solid, flat barrier that prevents air from flowing directly through diffuser material 3406 to wall 3428 (e.g., from the opposite side of surface 3414). Figure 4K In the middle, the deflector 3442 is bent in such a way that it can produce a similar effect to... Figure 4JThe flat deflector shown has a smoother transition compared to the sides extending beyond the diffuse material 3406. Although in Figure 4K Multiple deflectors 3442 are shown, but any number of pieces, including single pieces, can be used as needed to achieve the desired flow characteristics. For both forms of deflectors 3442, any suitable method can be used to create the deflectors 3442 within the diffuser material 3406. For example, appropriately shaped cutouts in the side of the diffuser material 3406 can allow the insertion of the deflectors 3442. Alternatively, the diffuser material 3406 can consist of multiple pieces, which are then connected around the diffuser material 3406.

[0196] In one respect, the diffuse material 3406 may be removable. For example, if the cover 3440 is attached in a releasable manner, the diffuse material 3406 may be held in place by mechanical retention via the cover 3440. Removing the cover 3440 will also remove the diffuse material 3406. However, in another respect, the diffuse material 3406 may be non-removable. For example, if the cover 3440 is attached to the vent 3400 such that the cover can only be removed by damaging the vent 3400, the diffuse material 3406 may be considered non-removable. Alternatively, the diffuse material 3406 may be permanently attached to the vent 3400, for example, by an adhesive, such that the diffuse material 3406 is damaged during removal. Even if the cover 3440 is removable without causing damage, the diffuse material 3406 may be secured in a manner that would damage or destroy it, thus making the diffuse material 3406 non-removable.

[0197] Although the boundary of the diffuse material 3406 is described as surface 3414, it may differ from the surface of a solid. The diffuse material 3406 may have many openings or gaps to allow a tortuous flow through it. Therefore, surface 3414 can also be considered as the boundary of the diffuse material 3406.

[0198] Ventilation vent 3400 can generate relatively low noise levels or suppress noise generated before sound waves reach the user. Preferably, the generated sound level is less than 28 dB(A). For example, the sound level can be 20-28 dB(A), 22-26 dB(A), or about 24 dB(A). These sound levels are low enough that neither the user nor their bed partner will be disturbed.

[0199] 4.3.5 Decoupling Structure In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball-and-socket joint.

[0200] 4.3.6 Connection Port Connection port 3600 allows connection to air circuit 4170.

[0201] 4.3.7 Forehead stent In one configuration, the patient interface 3000 includes a forehead support 3700.

[0202] 4.3.8 Anti-asphyxiation valve In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0203] Port 4.3.9 In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the 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.

[0204] 4.4 Glossary 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.

[0205] 4.4.1 General Rules 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.

[0206] 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.

[0207] For example, the ambient humidity relative to a 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.

[0208] In another instance, environmental stress can be stress that is directly around the body or outside the body.

[0209] 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.

[0210] 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.

[0211] 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.

[0212] 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' or 'air flow'.

[0213] 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 ventilation opening to allow exhaled air to flush the airway. Ql ) is the leakage flow from the patient interface system. Respiratory flow ( Qr ( ) is the airflow received into the patient's respiratory system.

[0214] humidifier: The word "humidifier" will be used to refer to a humidifying device that is constructed, arranged, or configured to provide a therapeutically beneficial amount of water (H2O) vapor to the airflow to alleviate a patient's medical respiratory symptoms.

[0215] 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.

[0216] 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.

[0217] 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.

[0218] Noise, ventilation (acoustic): In this article, ventilation noise refers to the noise generated by the flow of air through any ventilation port (such as a ventilation port in a patient interface).

[0219] patient: People, regardless of whether they have respiratory illnesses.

[0220] pressure: Force per unit area. Pressure can be expressed in units (including cm²H₂O, gf / cm²). 2 Measured within the range of (and hectopascals). 1 cm H2O equals 1 gf / cm³. 2 And it is approximately 0.98 hectopascals. In this specification, unless otherwise stated, pressure is given in cm H2O.

[0221] Pressure in the patient interface is represented by symbols Pm Give, and treat stress with symbols Pt The treatment pressure is given as the target value obtained at the current moment through the mask pressure Pm.

[0222] Respiratory pressure therapy (RPT): Air is supplied to the airway inlet at a therapeutic pressure that is typically positive relative to atmospheric pressure.

[0223] Ventilator: Mechanical devices that provide pressure support to patients to perform some or all of their breathing tasks.

[0224] 4.4.1.1 Materials 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.

[0225] Polycarbonate: Thermoplastic polymer of bisphenol A carbonate.

[0226] 4.4.1.2 Mechanical properties Resilience: The ability of a material to absorb energy during elastic deformation and release energy during venting.

[0227] Rebounding:When vented, it releases virtually all of its energy. This includes certain silicones and thermoplastic elastomers.

[0228] hardness: The material’s own ability to resist deformation (e.g., by Young’s modulus, or by indentation hardness scale measured on a standard sample size).

[0229] • 'Soft' materials may include silicone or thermoplastic elastomers (TPEs) and may be easily deformed, for example, under finger pressure.

[0230] · 'Hard' materials can include polycarbonate, polypropylene, steel or aluminum, and can be, for example, not easily deformed under finger pressure.

[0231] The hardness (or stiffness) 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.

[0232] Soft structures or components: A structure or component that will change shape, such as a bent structure, when subjected to a relatively short period of time, such as 1 second, to support its own weight.

[0233] Rigid structures or components: Structures or components that will not change shape substantially when subjected to the loads typically encountered during use. One example of this use is to set up and maintain a sealed relationship with the inlet of the patient's airway, for example, under a load of approximately 20 to 30 cm H2O pressure.

[0234] 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.

[0235] 4.4.2 Respiratory and Circulatory Systems Sleep apnea: According to some definitions, apnea is considered to have occurred when the flow rate drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Apnea is also considered to have occurred when, despite the patient's efforts, some obstruction of the airway prevents airflow. Central apnea is considered to have occurred when respiratory arrest is detected due to reduced or absent respiratory effort, even though the airway is open. Mixed apnea is considered to have occurred when reduced or absent respiratory effort occurs simultaneously with an obstructed airway.

[0236] Respiratory rate: A patient’s spontaneous respiratory rate is usually measured in breaths per minute.

[0237] Duty cycle: The ratio of inspiratory time (Ti) to total respiratory time (Ttot).

[0238] Trying to breathe: Spontaneous breathing involves the act of trying to breathe.

[0239] The expiratory portion of the respiratory cycle: The time period from the start of exhalation to the start of inhalation.

[0240] Traffic limit: Flow restriction is considered a state of mind in a patient's breathing where increased effort 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.

[0241] Inspiratory waveforms with flow rate type limitations: (i) Flat: It has a rising section followed by a relatively flat section, and then a falling section.

[0242] (ii) M-shape: It has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.

[0243] (iii) Chair shape: It has a single local peak at the leading edge, followed by a relatively flat portion.

[0244] (iv) Reverse chair shape: It has a relatively flat portion, followed by a single local peak at the trailing edge.

[0245] 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 described as having occurred when flow drops below a threshold for an extended period. Central inadequacy is described as having occurred when inadequacy is detected due to reduced respiratory effort. In one form for adults, any of the following can be considered inadequacy: (i) A 30% reduction in the patient's respiration lasting for at least 10 seconds, plus a corresponding 4% reduction in saturation; or (ii) The patient’s breathing is reduced (but at least 50%) for at least 10 seconds, accompanied by a decrease in saturation of at least 3% or arousal.

[0246] Hyperventilation: Traffic increased to levels higher than normal.

[0247] The inspiratory portion 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.

[0248] Openness (airway): The degree to which the airway is open, or the degree to which the airway is open. An open airway is open. Airway openness can be quantified, for example, by using a value of -1 for open and a value of zero (0) for closed (obstructed).

[0249] Positive end-expiratory pressure (PEEP): The pressure above atmospheric pressure in the lungs present at the end of exhalation.

[0250] Leakage flow (Qpeak): The maximum flow rate during the expiratory portion of the respiratory flow waveform.

[0251] 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 flow, as opposed to "true respiratory flow" or "real respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0252] Tidal volume (Vt) The volume of air inhaled or exhaled during normal breathing without additional effort.

[0253] (Inhalation) Time (Ti) :: The duration of the inspiratory portion of the respiratory flow waveform.

[0254] (Exhalation) Time (Te) The duration of the expiratory portion of the respiratory flow waveform.

[0255] (Total) Time (Ttot) 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.

[0256] Typical recent ventilation: Recent values ​​on some predetermined time scales tend to cluster around the ventilation volume values; that is, a measure of the central tendency of recent ventilation volume values.

[0257] 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).

[0258] Ventilation rate (Vent): The measure of the flow rate of gases exchanged by a patient's respiratory system. Measurements of ventilation volume 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.

[0259] 4.4.3 Ventilation rate 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.

[0260] Backup 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.

[0261] Cyclic: 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 2020 to stop delivering breaths at the end of the inspiratory portion of the respiratory cycle.

[0262] Positive expiratory airway pressure (EPAP): Base pressure, which is the pressure that varies during breathing to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0263] End-expiratory pressure (EEP): The ventilator will attempt to achieve the desired mask pressure at the end of the expiratory phase of the breath. If the pressure waveform template ( The value is zero at the end of expiration, that is, when =1 ( If ) = 0, then EEP equals EPAP.

[0264] Inspiratory Positive Airway Pressure (IPAP): The ventilator will attempt to achieve the maximum desired mask pressure during the inspiratory phase of breathing.

[0265] Stress support: Pressure support indicates the pressure increase during inspiratory breathing that exceeds the pressure increase during expiratory breathing, and typically refers to the pressure difference between the maximum inspiratory pressure and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference the ventilator is planned to achieve, rather than the difference it actually achieves.

[0266] 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.

[0267] Spontaneous / Timed (S / T): It attempts to detect the pattern of spontaneous breathing in patients who are initiating breathing with 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.

[0268] Swing difference: Equivalent term for stress support.

[0269] Caused by: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 through the patient's effort.

[0270] Typical recent ventilation: Typical recent ventilation (Vtyp) is a value around which recent measurements of ventilation on a predetermined time scale tend to cluster. For example, a measurement of the central tendency of recent historical ventilation measurements can be a suitable value for typical recent ventilation.

[0271] 4.4.4 Anatomical Structure 4.4.4.1 Facial Anatomy Nose wings: The outer walls or "wings" of each nostril (plural: nasal wings) Nasal alar angle: Nasal alar tip: The outermost point on the wing of the nose.

[0272] Point of nasal wing curvature (or nasal wing tip): The last point in the curved baseline of each nasal ala is found in the fold formed by the junction of the nasal ala and the cheek.

[0273] Ear Kuo: The entire visible external portion of the ear.

[0274] (Nose) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0275] (Nose) cartilage: The nasal cartilage includes the septum, lateral septum, and major and minor cartilages.

[0276] Nose columella: Separate the skin strip from the nostrils and extend it from the nasal protuberance to the upper lip.

[0277] Nasal columellar angle: The angle between the line drawn through the midpoint of the nostril and the line drawn perpendicular to the Frankfurt plane (the two lines intersect at the lower point of the nasal septum).

[0278] Frankfurt floor plan: A line extending from the lowest point of the eye socket edge to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0279] Between the eyebrows: Located on the soft tissue, it is the most prominent point in the midsagittal plane of the forehead.

[0280] External nasal cartilage: It is generally a triangular cartilage 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.

[0281] Greater alar cartilage:The cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four small cartilages, including the alar.

[0282] 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.

[0283] Nasolabial folds or nasolabial folds: The skin folds or grooves that extend from each side of the nose to the corners of the mouth separate the cheeks from the upper lip.

[0284] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0285] Base point under the ear: The auricle is attached to the lowest point of the facial skin.

[0286] Base point on the ear: The auricle is attached to the highest point of the facial skin.

[0287] Nasal protrusion: The most prominent point or tip of the nose can be identified in a side view of the rest of the head.

[0288] 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.

[0289] Anterior chin point: Located on the soft tissue, at the midpoint of the front part of the chin.

[0290] Back (nose): The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0291] Sagittal plane: The vertical plane that divides the body into the right and left halves passes from the front to the back.

[0292] Bridge of the nose point: Located on the soft tissue, it is the most concave point covering the frontonasal suture area.

[0293] Septal cartilage (nose): The nasal septum cartilage forms part of the septum and divides the anterior part of the nasal cavity.

[0294] Rear upper side panel: The point at the lower edge of the base of the nostril, where the base of the nostril connects to the skin of the upper (upper) lip.

[0295] Subnasal point: Located on soft tissue, at the point where the columella meets the upper lip in the midsagittal plane.

[0296] 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.

[0297] 4.4.4.2 Anatomical Structure of the Skull Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0298] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0299] 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.

[0300] Nasal bone: The 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.

[0301] Root of the nose: The intersection of the frontal bone and the two nasal bones is located directly between the eyes and in the depression on the upper part of the bridge of the nose.

[0302] 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.

[0303] Eye socket: The bony cavity in the skull that houses the eyeball.

[0304] Parietal bone: The parietal bone is the top and sides of the skull that, when joined together, form the top of the skull.

[0305] 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.

[0306] 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.

[0307] 4.4.4.3 Anatomical Structure of the Respiratory System Diaphragm: A muscular plate extending across the base of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0308] throat: The larynx or larynx houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0309] lung: The human respiratory system. The conduction zone of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0310] 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.

[0311] pharynx: The pharynx is located just below the nasal cavity and above the esophagus and larynx. It is conventionally divided into three parts: the nasopharynx (hyperpharynx) (the nasal portion of the pharynx), the oropharynx (middle pharynx) (the oral portion of the larynx), and the laryngopharynx (hypopharynx).

[0312] 4.4.5 Patient Interface Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0313] 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.

[0314] frame: The frame is 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.

[0315] 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.

[0316] membrane: The membrane will be considered to refer to a typically thin element that preferably has essentially no resistance to bending but has resistance to tension.

[0317] Inflation chamber: A mask inflation chamber is considered to refer to part of a patient interface having walls that surround a volume of space, which, during use, contains air pressurized to above atmospheric pressure. A housing may form part of the walls of the mask inflation chamber.

[0318] seal: It can be the noun form indicating the structure ("seal") or the verb form indicating the action ("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.

[0319] 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.

[0320] 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.

[0321] Support: The support is considered to be a structural component designed to increase the compressibility of another component in at least one direction.

[0322] Rotation axis (noun): Sub-assemblies of an assembly configured to rotate about a common axis are preferably independent, 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-assemblies of the assembly preferably comprise a pair of mating cylindrical ducts. During use, there may be little or no airflow leakage from the shaft.

[0323] Lace-up (noun):Designed to resist tension.

[0324] Ventilation port (noun): Structures that allow airflow from inside the mask or tubing to ambient air to enable clinically effective flushing of exhaled gases. 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.

[0325] 4.4.6 Shape of the structure Products according to this technology may include one or more three-dimensional mechanical structures, such as mask buffers or thrusters. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a surface that contacts the face (e.g., the exterior) and separate surfaces that do not contact the face (e.g., the underside or interior). In yet another example, a structure may include a first surface and a second surface.

[0326] To aid in describing the shape of three-dimensional structures and surfaces, we first consider a point on the surface of the structure. p The cross-section. See also Figures 3B to 3F They show points on the surface. p Examples of cross-sections at the location and the resulting planar profile. Figures 3B to 3F It also shows in p The outward normal vector at that location. p The outward normal vector at a point is away from the surface. In some instances, the surface is described from the observation point of an imaginary little person standing upright on the surface.

[0327] 4.4.6.1 Curvature in one dimension 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).

[0328] 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.

[0329] Zero curvature: If inp 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 .

[0330] 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.

[0331] 4.4.6.2 Curvature of Two-Dimensional Surfaces A description of the shape at a given point on a two-dimensional surface according to the present 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.

[0332] 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.

[0333] Surface area: A set of points connected on a surface. The points in the region may have similar characteristics, such as curvature or sign.

[0334] Saddle-shaped region: The region at each point has the principal curvature with opposite signs, i.e., one sign is positive and the other sign is negative (depending on the direction the imagined individual is turning, they can walk up or down).

[0335] 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").

[0336] 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.

[0337] Planar area: Surface regions where both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0338] Surface edge: The boundary or limit of a surface or area.

[0339] 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).

[0340] Path length: In some forms of this technique, the 'path length' will be along the surface from f (0) to f (1) The distance, i.e., 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 imagined individual would be the distance they walk along the path on the surface).

[0341] 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'.) 4.4.6.3 Space Curves Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, meaning they have no endpoints. A space curve can be thought of as a one-dimensional sheet of three-dimensional space. Imagine an imaginary individual walking along a space curve on a DNA helix. A typical human left ear includes a helix, and its left side also includes a helix; see [link to image]. Figure 3Q A typical human right ear includes a spiral, and its right spiral, see [link to relevant documentation]. Figure 3R . Figure 3S A right-handed helix is ​​shown. The edges of a structure, such as a membrane or thruster, can follow a space curve. Generally, a space curve can be described by the curvature and torque at each point on the space curve. Torque is a measure of how the curve deviates from the surface. Torque has a sign and a quantity. The torque at a point on a space curve can be characterized by reference to the tangent, normal, and binormal vector at that point.

[0342] 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.

[0343] 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.

[0344] 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.

[0345] Close plane: A plane containing a unit tangent vector and a unit principal normal vector. See also Figure 3O and 3P .

[0346] Torque of the space curve: The torque 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 oscillating plane. A space curve lying on the plane has zero torque. A space curve deviating slightly from the oscillating plane will have a relatively small amount of torque (e.g., a slightly inclined spiral path). A space curve deviating significantly from the oscillating plane will have a relatively large amount of torque (e.g., a sharply inclined spiral path). Reference Figure 3S Although T2 > T1, in Figure 3S The amount of torque near the top helical coil is greater than Figure 3S The amount of torque of the bottom spiral coil.

[0347] 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 torque (e.g., as...). Figure 3S (As shown in the right-handed helix). A space curve deviating from the direction of the right-handed binormal can be considered to have a right-handed negative torque (e.g., a left-handed helix).

[0348] Similarly, and referring to the left-hand rule (see...) Figure 3O A space curve that deviates towards the left-hand secondary normal can be considered to have a left-hand positive torque (e.g., a left-hand spiral). Therefore, a left-hand positive torque is equivalent to a right-hand negative torque. See also Figure 3T .

[0349] 4.4.6.4 Hole 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.

[0350] 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 buffer and Figure 3M and Figure 3N An exemplary cross-section passing through it is shown, wherein the inner surface defines the indicated 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.

[0351] 4.5 Other Notes 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 person making a copy of this patent document or the patent disclosure, but otherwise retains all copyright rights.

[0352] 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 such 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.

[0353] Furthermore, in cases where one or more values ​​of 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.

[0354] 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.

[0355] When a particular material is identified for use in a component, a clearly alternative material with similar properties is used as its substitute. Furthermore, unless otherwise stated, all components herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0356] It must be noted that, unless the context clearly specifies otherwise, the singular forms “a (an)” and “the” as used herein and in the appended claims include their plural equivalents.

[0357] 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.

[0358] The terms “comprises” and “comprising” 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.

[0359] 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.

[0360] 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.

[0361] 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.

[0362] 4.6 List of Figure Labels 1000 patients 1100 bed partners 3000 patient interface 3100 sealing structure 3200 air chamber 3300 structure 3400 air exchanger Channel 3402 3404 wall 3406 diffuse material 3408 housing 3410 air passage 3412 gap 3412A Part 2 3414 surface 3416 opening Part 3418 3420 opening 3422 arrow 3424 opening 3426 components 3428 wall 3430 center line 3432 center line 3434 support component 3436 side surface 3438 Groove 3440 cover 3442 deflector 3600 connection port 3700 Forehead Brake 4000RPT device 4170 air circuit 5000 Humidifier.

Claims

1. A gas flushing vent for a patient interface system, configured to maintain a treatment pressure within a range of about 4 cmH2O to about 30 cmH2O above ambient pressure during use throughout the patient's respiratory cycle, while the patient is asleep, to improve respiratory or sleep-disordered breathing, said gas flushing vent comprising: A housing, the housing including a first wall having one or more channels extending through the first wall, the one or more channels being configured to be in fluid communication with a portion of the patient interface system, the portion of the patient interface system being configured to be exposed to the treatment pressure, the channels including corresponding first openings on a first surface of the first wall, the housing at least partially defining a second opening in communication with the ambient atmosphere; as well as A diffuse material, at least partially located within the housing adjacent to the first surface, the surface of the diffuse material facing the first surface being spaced apart from the first surface by a gap extending to provide fluid communication between all the first openings and between all the first openings and the second opening; The housing is configured to prevent air from flowing out of the housing in all areas directly opposite each of the first openings.

2. The gas flushing vent of claim 1, wherein the housing further comprises a third opening communicating with the ambient atmosphere, wherein the third opening does not overlap with the outlet area of ​​any channel projecting along the central axis of the respective channel, and is positioned such that at least a portion of the diffuse material is located between each first opening and the third opening.

3. The gas flushing vent according to claim 2, wherein the third opening is oriented such that the central axis passing through the third opening is angled relative to the central axis of any channel.

4. The gas flushing vent according to claim 2 or 3, wherein the third opening is sized such that when a portion of the patient interface is exposed to the treatment pressure, completely blocking the third opening does not significantly reduce the airflow through the gas flushing vent.

5. The gas flushing vent according to claim 4, wherein the airflow through the gas flushing vent does not decrease by more than three percent.

6. The gas flushing vent according to any one of claims 2 to 5, wherein the third opening is one of a plurality of third openings.

7. The gas flushing vent according to any one of claims 2 to 6, wherein, The third opening is configured to remove water.

8. The gas flushing vent according to any one of claims 1 to 6, wherein the second opening comprises a plurality of second openings.

9. The gas flushing vent according to any one of claims 1 to 8, wherein at least one of the one or more channels is sized such that when a portion of the patient interface is exposed to the treatment pressure, at least a portion of the air leaving the corresponding first opening permeates into the diffuser material.

10. The gas flushing vent of claim 9, wherein the gas flushing vent is configured such that a portion of the air that has permeated into the diffuser material leaves the diffuser material and re-enters the gap before flowing out from the second opening.

11. The gas flushing vent according to any one of claims 9 or 10, wherein the gas flushing vent is configured such that a portion of the air leaving the respective first opening permeates through the surface and exits the diffuser material.

12. The gas flushing vent according to any one of claims 1 to 11, wherein when air leaves the second opening, noise of no more than 28 dB(A) is generated due to a portion of the patient interface being exposed to the treatment pressure.

13. The gas flushing vent according to any one of claims 1 to 12, wherein the diffuser material comprises uncompressed fibers.

14. The gas flushing vent according to any one of claims 1 to 12, wherein the diffuser material comprises a moisture-absorbing material.

15. The gas flushing vent according to claim 14, wherein the moisture-absorbing material is sintered plastic.

16. The gas flushing vent according to any one of claims 1 to 12, wherein the diffuser material comprises a hydrophobic material.

17. The gas flushing vent according to any one of claims 1 to 16, wherein the diffuser material has antibacterial properties.

18. The gas flushing vent according to any one of claims 1 to 17, wherein the first wall is fixed within the housing in a non-releasable manner.

19. The gas flushing vent according to any one of claims 1 to 18, wherein the gap is at least partially defined by the first wall from the first opening to the second opening.

20. The gas flushing vent of claim 19, wherein the gap is formed by a portion of the diffuse material extending from a position opposite the first opening to the portion closest to the second opening.

21. The gas flushing vent according to any one of claims 1 to 20, wherein the gap narrows in the radial direction.

22. The gas flushing vent according to claim 21, wherein the gap gradually narrows in the radially outward direction.

23. The gas flushing vent according to any one of claims 1 to 22, wherein the surface of the diffuser material is parallel to the first surface.

24. The gas flushing vent according to any one of claims 1 to 22, wherein the surface of the diffused material is inclined to the first surface.

25. The gas flushing vent according to any one of claims 1 to 22, wherein a portion of the housing is removable to allow replacement of the diffuser material.

26. The gas flushing vent according to any one of claims 1 to 25, wherein the dimensions of the second opening and the gap are configured such that as air flows through the channel, the gap and the second opening, most of the pressure decreases before the air leaves the channel.

27. The gas flushing vent according to any one of claims 1 to 26, wherein the gas flushing vent includes a separate device for engaging with a patient interface or air circuit.

28. The gas flushing vent according to claim 1, wherein the second opening is spaced apart from the first surface in a direction perpendicular to the first surface.

29. The gas flushing vent according to claim 1 or 28, wherein the second opening faces the side surface of the diffuse material.

30. The gas flushing vent according to claim 29, wherein the side surface of the diffuse material is transverse to the surface of the diffuse material facing the first surface.

31. The gas flushing vent according to any one of claims 28 to 30, wherein the gap is adjacent to two surfaces of the diffuse material that are laterally opposite to each other.

32. The gas flushing vent according to any one of claims 1 to 31, further comprising a deflector within the diffuser material, the deflector being configured to prevent air entering the surface of the diffuser material facing the first surface from flowing directly through the diffuser material and exiting from the opposite side of the diffuser material.

33. A system for treating respiratory disturbances in patients, comprising: Respiratory pressure therapy device; humidifier; Air circuit; as well as Patient interface At least one of the air circuit and the patient interface includes a gas flushing vent according to any one of claims 1 to 32.

34. A gas flushing vent for a patient interface system, configured to maintain a treatment pressure within a range of about 4 cmH2O to about 30 cmH2O above ambient pressure during use throughout the patient's respiratory cycle, while the patient is sleeping, to improve respiratory or sleep-disordered breathing, said gas flushing vent comprising: Inflation chamber; and Gas flushing vents, including: A housing comprising a first wall having one or more channels through the first wall, the one or more channels being configured to provide fluid communication with the patient interface system configured to be exposed to therapeutic pressure, each of the one or more channels including a corresponding first opening on a first surface of the first wall, the housing at least partially defining a second opening in communication with the ambient atmosphere; and A diffuse material, which is at least partially located within the housing to be adjacent to the first surface, the surface of the diffuse material facing the first surface being spaced apart from the first surface by a gap extending to provide fluid communication between all the first openings, and fluid communication between all the first openings and the second opening; The housing is configured to prevent air from exiting the housing in all areas directly opposite each of the first openings; and The gap extends from one side of the air vent to the other side.

35. A gas flushing vent for a patient interface system, configured to maintain a treatment pressure within a range of about 4 cmH2O to about 30 cmH2O above ambient pressure during use throughout the patient's respiratory cycle, while the patient is sleeping, to improve respiratory or sleep-disordered breathing, said gas flushing vent comprising: Inflation chamber; and Gas flushing vents, including: A housing comprising a first wall having one or more channels through the first wall, the one or more channels being configured to provide fluid communication with the patient interface system configured to be exposed to therapeutic pressure, each of the one or more channels including a corresponding first opening on a first surface of the first wall, the housing at least partially defining a second opening in communication with the ambient atmosphere; and A diffuse material, which is at least partially located within the housing to be adjacent to the first surface, the surface of the diffuse material facing the first surface being spaced apart from the first surface by a gap extending to provide fluid communication between all the first openings, and fluid communication between all the first openings and the second opening; The housing is configured to prevent air from exiting the housing in all areas directly opposite each of the first openings; and It also includes components that support the diffuse material and / or the housing in the working position.

36. A gas flushing vent for a patient interface system, configured to maintain a treatment pressure within a range of about 4 cmH2O to about 30 cmH2O above ambient pressure during use throughout the patient's respiratory cycle, while the patient is sleeping, to improve respiratory or sleep-disordered breathing, said gas flushing vent comprising: Inflation chamber; and Gas flushing vents, including: A housing comprising a first wall having one or more channels through the first wall, the one or more channels being configured to provide fluid communication with the patient interface system configured to be exposed to therapeutic pressure, each of the one or more channels including a corresponding first opening on a first surface of the first wall, the housing at least partially defining a second opening in communication with the ambient atmosphere; and A diffuse material, which is at least partially located within the housing to be adjacent to the first surface, the surface of the diffuse material facing the first surface being spaced apart from the first surface by a gap extending to provide fluid communication between all the first openings, and fluid communication between all the first openings and the second opening; The housing is configured to prevent air from escaping from the housing in all areas directly opposite each of the first openings; and The housing also includes a plurality of third openings communicating with the ambient atmosphere; The plurality of third openings are discontinuous with each other and / or discontinuous with the second opening.

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