Seal forming structure and positioning and stabilizing structure for patient interface

Abstract

The utility model relates to a seal forming structure and a positioning and stabilizing structure for a patient interface. A seal-forming structure for a patient interface includes a seal-forming region formed of a cushioning material, wherein the cushioning material has a patient-facing elastomeric non-woven material. A positioning and stabilizing structure for a patient interface includes a cushioning material, where the cushioning material includes an elastomeric non-woven material.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Application No. 63 / 527,658, filed July 19, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] This technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses. Background Technology

[0004] Human respiratory system and its disorders

[0005] The human respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airway.

[0006] The airways consist of a series of branching tubes that become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into the venous blood, and carbon dioxide to move in the opposite direction. The trachea divides into the right main bronchus and the left main bronchus, which eventually further divide into the terminal bronchioles. The bronchi form the conduction airways and do not participate in gas exchange. Further branches of the airways lead to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory region. See John B. West's *Respiratory Physiology*, 9th edition, Lippincott Williams & Wilkins, 2012.

[0007] There are a range of breathing disorders. Some disorders may be characterized by specific events (e.g., apnea, hypoventilation, and hyperventilation).

[0008] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0009] 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 an abnormally small upper airway and a normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often causes excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. This syndrome is a common disorder, particularly prevalent in middle-aged overweight men, but those affected may not be aware of the problem, see, for example, U.S. Patent No. 4,944,310 (Sullivan).

[0010] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Due to the repetitive hypoxia, CSR can be harmful. In some patients, CSR is associated with repetitive micro-arousals from sleep, which cause severe sleep disruption, increased sympathetic activity, and increased afterload, see, for example, U.S. Patent No. 6,532,959 (Berthon-Jones).

[0011] 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 can cover some or all of the following disorders.

[0012] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0013] Obesity-induced hypoventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0014] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These include increased airflow resistance, prolonged expiratory phase, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0015] Neuromuscular disease (NMD) is a broad term encompassing many diseases and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath at exercise and rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0016] Chest wall disorders are a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0017] A range of therapies have been used to treat or improve these conditions. Furthermore, other healthy individuals can utilize these therapies to prevent respiratory distress. However, these therapies have many drawbacks.

[0018] therapy

[0019] Various respiratory therapies, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), have been used to treat one or more of the aforementioned respiratory disorders.

[0020] Respiratory pressure therapy

[0021] Respiratory pressure therapy is the application of supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy such as canister ventilators or thoracic ventilators).

[0022] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction, for example, by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary, and therefore patients may choose not to adhere to the therapy if they find the device used to deliver such therapy uncomfortable, difficult to use, expensive, or unsightly, among other things.

[0023] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the breathing work. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat forms of chronic respiratory failure (CSR) such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0024] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively and can be delivered using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0025] Flow therapy

[0026] Not all respiratory therapies are designed to deliver a prescribed therapeutic pressure. Some respiratory therapies are designed to deliver a prescribed respiratory volume by delivering an inspiratory flow rate profile (possibly superimposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and the respiratory therapy may supplement only the patient's own spontaneous breathing with a regulated or enriched flow of gas. In one instance, high-flow-rate therapy (HFT) can be a continuous, heated, humidified flow of air to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that remains substantially constant throughout the respiratory cycle. This therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow rate of air at the airway inlet improves ventilation efficiency by flushing or washing away exhaled CO2 from the patient's anatomical dead zone. Therefore, HFT is sometimes referred to as dead-zone therapy (DST). Other benefits may include increased warmth and humidity (which may be beneficial in secretion management) and the possibility of appropriately increasing airway pressure. As an alternative to constant flow, therapeutic flow can follow a curve that varies throughout the respiratory cycle.

[0027] Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. Doctors can prescribe a continuous flow of oxygen-enriched air into the patient's airway at a specific oxygen concentration (from 21% to 100% of the oxygen fraction in ambient air) and at a specific flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0028] Respiratory therapy system

[0029] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.

[0030] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0031] Patient Interface

[0032] Patient interfaces can be used to attach breathing equipment to their wearer, for example, by providing an airflow into the airway inlet. The airflow can be provided to the patient's nose and / or mouth via a mask, to the patient's mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy applied, the patient interface can, for example, form a seal with an area of ​​the patient's face to facilitate the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of about 10 cmH2O relative to ambient pressure). For other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply to the airway at a positive pressure of about 10 cmH2O. For flow-through therapies such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0033] Some mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems designed for underwater swimming or diving may be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient.

[0034] For this technology, certain masks may be clinically disadvantageous, such as those that block airflow through the nose and only allow airflow through the mouth.

[0035] If some masks require the patient to insert a portion of the mask structure into their mouth to create and maintain a seal through their lips, these masks may be uncomfortable or impractical for this technology.

[0036] Some face masks may not be very practical to use while sleeping, for example, when the head is resting on a pillow and the person is sleeping on their side in bed.

[0037] Some masks may cause claustrophobia, anxiety and / or may feel too abrupt to some patients.

[0038] The design of the patient interface presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head comprises bones, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jawbone or mandible can move relative to the other bones of the skull. The entire head can move during respiratory therapy sessions.

[0039] Therefore, some masks have disadvantages such as being obtrusive, unsightly, expensive, poorly fitted, difficult to use, and / or uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized mask can lead to reduced adherence, decreased comfort, and poorer patient outcomes. Masks designed solely for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for administering anesthetics are acceptable for their original application, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment, especially if the mask is worn during sleep.

[0040] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing difficulties. Patients may not adhere to therapy if the mask is uncomfortable or difficult to use. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean it, which could affect patient adherence.

[0041] 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.

[0042] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0043] Sealing Formation Structure

[0044] Patient interfaces may include seal-forming structures. Because the seal-forming structures come into direct contact with the patient's face, their shape and configuration can directly affect the effectiveness and comfort of the patient interface.

[0045] Patient interfaces can be characterized in part by their design intent regarding where the sealing structure will 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 that surrounds both nostrils during use. This single element may be designed, for example, to cover the upper lip and bridge of the nose area of ​​the face. In another form of patient interface, the sealing structure may include an element that surrounds the mouth area during use, for example, by forming a seal on the lower lip area of ​​the face. In yet another form of patient interface, the sealing structure may include a single element that surrounds both nostrils and the mouth area during use. These different types of patient interfaces may be named by their manufacturers under various names, including nasal masks, full-face masks, nasal pillows, nasal puffs, and oronasal masks.

[0046] For example, due to the different shapes, structures, variability, and sensitive areas of a patient's face, a sealing structure that may be effective in one area of ​​the patient's face may not be suitable in another area. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0047] Certain seal-forming structures can be designed for mass production, allowing a design to fit comfortably and effectively for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the patient's facial shape and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0048] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface during face-to-face engagement of the seal-forming structure. The seal-forming structure may include an air- or fluid-filled gasket, or a molded or shaped surface of an elastic sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0049] Another type of seal-forming structure incorporates a wing seal of thin material positioned around the periphery of the mask to provide a self-sealing effect against the patient's face when positive pressure is applied inside the mask. Similar to the previous type of seal-forming section, additional force may be required to achieve a seal if the fit between the face and the mask is poor; otherwise, 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.

[0050] Another type of sealing structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0051] Another form of sealing can be achieved using adhesives. Some patients may find it inconvenient to frequently apply and remove adhesives from their face.

[0052] A series of patient interface sealing structure technologies are disclosed in the following patent applications: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0053] One form of nasal pillow was found in the 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.

[0054] ResMed Inc. has manufactured the following products that incorporate a nose pillow: SWIFT TM Nose pillow cover, SWIFT TM II Nose pillow cover, SWIFT TM LT nose pillow cover, SWIFT TM FX nose pillow and MIRAGE LIBERTY TM Full-face mask. The following patent application describes an example of a nose pillow mask: International Patent Application WO 2004 / 073778 (describes SWIFT). TM Other aspects of the nose pillow cover), U.S. Patent Application 2009 / 0044808 (describes SWIFT) TM Other aspects of the LT nose pillow cover); International patent applications WO 2005 / 063328 and WO 2006 / 130903 (describe MIRAGE LIBERTY) TM Other aspects of the full-face mask); International Patent Application WO 2009 / 052560 (describes SWIFT) TM Other aspects of the FX nose pillow cover).

[0055] Positioning and stabilizing structure

[0056] The seal-forming structure of a patient interface used in positive pressure therapy is subjected to a force corresponding to the air pressure that would disrupt the seal. Therefore, various techniques have been used to position the seal-forming structure and maintain its seal with the appropriate portion of the face. When comparing different positioning and stabilization techniques, many factors can be considered. These include: the effectiveness of the technique in maintaining the seal-forming structure in the desired position and sealing it with the face during use of the patient interface; the comfort of the interface for the patient; whether the patient experiences invasiveness and / or claustrophobia while wearing the patient interface; and aesthetic appeal.

[0057] One technique involves using adhesives, see, for example, U.S. Patent Application Publication No. 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0058] Another technique involves using one or more straps and / or stabilizing straps. Many of these straps suffer from one or more problems, such as poor fit, bulkiness, discomfort, and inconvenience of use.

[0059] pressurized air duct

[0060] In one type of treatment system, pressurized airflow is supplied to the patient interface via a conduit in an air circuit. When the patient interface is positioned over the patient's face during use, the air circuit is fluidly connected to the patient interface at a location anterior to the patient's face. The conduit may extend forward from the patient interface away from the patient's face.

[0061] Pressurized air ducts used for positioning / stabilizing sealing structures

[0062] Another type of treatment system includes a patient interface in which the tubing that delivers pressurized air to the patient's airway also acts as part of a headgear to position and stabilize a sealing portion of the patient interface at the appropriate location on the patient's face. This type of patient interface may be referred to as having a "catheter headgear" or "headgear tubing." Such patient interfaces allow a catheter in the air circuit that provides a flow of pressurized air from a respiratory pressure therapy (RPT) device to be connected to the patient interface at a location other than the front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication No. US2007 / 0246043, the contents of which are incorporated herein by reference, wherein the catheter is connected to the tubing in the patient interface via a port positioned on the top of the patient's head during use.

[0063] Ideally, the patient interface with a head sleeve should allow the patient to feel comfortable during prolonged wear while asleep, forming an airtight and stable seal with the patient's face, while also conforming to a certain range of the patient's head shape and size.

[0064] Respiratory Pressure Therapy (RPT) device

[0065] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned therapies, such as by operating the device to generate an airflow for delivery to an interface in the airway. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow-based therapies such as HFT). Therefore, RPT devices can also be used as flow-based therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0066] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that more general air pressure generators cannot meet, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical treatment may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0067] An example of a specific requirement for certain RPT devices is acoustic noise.

[0068] Noise output level table for existing RPT devices (only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0069]

[0070] One known RPT device for treating sleep-disordered breathing is the ResMed S9 Sleep Therapy System. Another example of an RPT device is a ventilator. ResMed Stellar ventilators, such as those for adults and pediatrics, are also available. TM The series can provide invasive and non-invasive non-dependent ventilation support for a range of patients to treat a variety of conditions, such as, but not limited to, NMD, OHS and COPD.

[0071] Elisée TM 150 ventilator and ResMed VSIII TM Ventilators can provide invasive and non-invasive ventilation support for adult or pediatric patients to treat a variety of conditions. These ventilators offer volumetric and pressure ventilation modes with single or dual-branch circuits. RPT devices typically include a pressure generator, such as an electric motor-driven blower or a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, the airflow can be supplied to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0072] Device designers may face countless choices. Design standards often conflict, meaning some design choices are unconventional or unavoidable. Furthermore, comfort and efficiency in certain aspects may be highly sensitive to minute variations in one or more parameters.

[0073] Ventilation technology

[0074] Some forms of therapeutic systems may include a vent to allow the flushing of exhaled carbon dioxide. The vent may allow gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the outside of the patient interface (e.g., to the surrounding environment).

[0075] Ventilation ports may include openings through which air can flow during mask use. Many such ventilation ports are noisy. Other ventilation ports may become clogged during use and therefore not flushed adequately. Some ventilation ports may, for example, disturb the sleep of the patient's bed partner through noise or concentrated airflow.

[0076] ResMed has developed many improved mask ventilation technologies, see, for example, International Patent Application Publication No. WO 1998 / 034665; International Patent Application Publication No. WO 2000 / 078381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0077] The noise level of the existing face mask (ISO 17510-2:2007, pressure at 1m and 10cmH2O)

[0078]

[0079] (*Only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744)

[0080] The sound pressure levels for each object are listed below.

[0081]

[0082] Screening, diagnosis and monitoring systems

[0083] Polysomnography (PSG) is a routine system used for diagnosing and monitoring cardiopulmonary disorders, and its application typically involves a clinical specialist. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalograms (EEG), electrocardiograms (ECG), electrooculograms (EOG), and electromyograms (EMG). For sleep-disordered breathing, PSG involves two nights of observation in a clinic: one night for pure diagnosis, and the second night for titration of treatment parameters by a clinician. Therefore, PSG is both expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0084] Screening and diagnosis are generally described as identifying a condition based on its signs and symptoms. Screening typically provides a true / false result indicating whether a patient's SDB is severe enough to require further investigation, while diagnosis provides clinically actionable information. Screening and diagnosis tend to be one-off processes, while monitoring disease progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0085] Clinicians can adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where clinicians lack the time or cannot afford the fees. Different clinicians may have differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. Utility Model Content

[0086] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0087] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0088] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0089] One aspect of certain forms of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0090] One form of this technology includes a positioning and stabilizing structure configured to provide forces that hold the sealing structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes at least one band.

[0091] One form of this technology includes a patient interface comprising an inflation chamber, a sealing formation structure, and a positioning and stabilizing structure.

[0092] One form of this technology includes a patient interface comprising an inflatable chamber pressurizable to a treatment pressure at least 4 cmH2O above ambient air pressure. The inflatable chamber includes at least one inflatable chamber inlet port, the size and configuration of which are determined to receive an airflow at the treatment pressure for patient breathing. The patient interface also includes a sealing structure configured and arranged to seal with an inlet region of the patient's face surrounding the patient's airway. The sealing structure has an opening therein, such that an airflow at the treatment pressure is delivered at least to the inlet of the patient's nostrils. The sealing structure is configured and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's respiratory cycle in use. The patient interface also includes positioning and stabilizing structures to provide forces to hold the sealing structure in a therapeutically effective position on the patient's head.

[0093] Another aspect of this technology is a series of modular elements that can be interconnected to form different types of patient interfaces.

[0094] In one form, each modular element has at least two styles or types. These styles or types can be used interchangeably to form different modular components.

[0095] One form of this technology includes a sealing structure for a patient interface, the sealing structure including a sealing region formed of a cushioning material, wherein the cushioning material includes a patient-facing elastomeric nonwoven material.

[0096] Another aspect of this technology includes a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure including a cushioning material, wherein the cushioning material includes an elastomeric nonwoven material.

[0097] Another aspect of this technology is a positioning and stabilizing structure for a patient interface, the positioning and stabilizing structure including a cushioning material, wherein the cushioning material includes an elastomeric nonwoven material, wherein the elastomeric nonwoven material is combined with a flexible and / or elastic material, wherein the flexible and / or elastic material is a fabric material or a composite material.

[0098] Another aspect of this technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0099] One aspect of this technology is a method for manufacturing equipment.

[0100] Another aspect of this technology is a method for assembling a modular system, including selecting positioning and stabilizing structures and connecting the positioning and stabilizing structures to a first liner or a second liner.

[0101] One aspect of certain forms of this technology is an easy-to-use medical device, for example, easy to use by a person without medical training, a person with limited dexterity and vision, or a person with limited experience in using this type of medical device.

[0102] One aspect of this technology is a portable RPT device that can be carried by a person (e.g., a member of that person's household).

[0103] One aspect of this technology is a patient interface that can be cleaned at the patient's home, for example, in soapy water, without the need for specialized cleaning equipment. Another aspect of this technology is a humidifier water tank that can be cleaned at the patient's home, for example, in soapy water, without the need for specialized cleaning equipment.

[0104] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors (such as processors in dedicated computers, respiratory monitors, and / or respiratory therapy devices). Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0105] Of course, the various parts of these aspects can form sub-aspects of this technology. Furthermore, sub-aspects and / or aspects of each aspect can be combined in various ways and also constitute additional aspects or sub-aspects of this technology.

[0106] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description

[0107] The technology is illustrated by way of example and not limitation in the various figures of the accompanying drawings, wherein similar reference numerals refer to similar elements, including:

[0108] Respiratory therapy system

[0109] Figure 1A A system including a patient 1000 is shown, who wears a patient interface 3000 in the form of a nose pillow and 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 is sleeping in a supine position.

[0110] Figure 1B A system including 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.

[0111] Figure 1C A system including a patient 1000 wearing a full-face mask-like patient interface 3000 receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a side-lying position.

[0112] Respiratory system and facial anatomy

[0113] 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.

[0114] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0115] Figure 2C It is a frontal view of a face with many recognizable surface anatomical features, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the lips. It also indicates the directions of up, down, radially inward, and radially outward.

[0116] Figure 2D It is a side view of the head with many recognizable surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal point, upper lip, lower lip, supramental point, nasal ridge, alar ridge, supraauricular base, and subauricular base. The vertical and horizontal directions are also indicated.

[0117] Figure 2E This is another side view of the head. It indicates the approximate location of the Frankfort horizontal plane and the nasolabial angle. The coronal plane is also indicated.

[0118] Figure 2F A bottom view of the nose with many recognizable features is shown, including the nasolabial groove, lower lip, vermilion border of the upper lip, nostrils, subnasal point, columella, nasal protuberance, long axis of the nostrils, and midsagittal plane.

[0119] Figure 2GA side view showing the surface features of the nose.

[0120] 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.

[0121] Figure 2I An anatomical view of the medial part of the nose is shown, approximately a few millimeters from the midsagittal plane, with particular emphasis on the medial crus of the septal cartilage and the greater alar cartilage.

[0122] Figure 2J A frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone, is shown. The nasal conchae, as well as the maxilla and mandible, are also indicated.

[0123] Figure 2K This diagram shows a side view of the skull, including the surface contours 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 indicated. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0124] Figure 2L The frontal lateral view of the nose is shown.

[0125] Patient Interface

[0126] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0127] Figure 3B A schematic diagram of a cross-section passing through the structure at a single 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.

[0128] Figure 3C A schematic diagram of a cross-section passing through the structure at a single 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.

[0129] Figure 3D A schematic diagram of a cross-section passing through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a zero value.

[0130] Figure 3E A schematic diagram of a cross-section passing through 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 3FThe curvature amplitude shown has a relatively small amplitude compared to that shown.

[0131] Figure 3F A schematic diagram of a cross-section passing through 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.

[0132] Figure 3G The padding for a face mask comprising two pillows is shown. The outer surface of the padding is indicated. The edges of the surface are indicated. The vaulted and saddle-shaped areas are indicated.

[0133] Figure 3H The padding used for the face mask is shown. The outer surface of the padding is indicated. The edge of the surface is indicated. The path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle-shaped areas and one dome area are indicated.

[0134] Figure 3I The diagram shows a surface with a structure having a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.

[0135] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface shown in the figure is... Figure 3I The structure defines a two-dimensional hole.

[0136] Figure 3K It shows Figure 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is... Figure 3I The surface of the two-dimensional hole is defined in the structure.

[0137] Figure 3L A face mask with an inflatable air bladder as padding is shown.

[0138] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the bladder is also shown. This inner surface defines a two-dimensional aperture in the mask.

[0139] Figure 3N It shows crossing Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0140] Figure 3O The diagram illustrates the left-hand rule.

[0141] Figure 3P The right-hand rule is illustrated.

[0142] Figure 3Q The left ear is shown, including the left ear spiral.

[0143] Figure 3R The right ear is shown, including the right ear spiral.

[0144] Figure 3S A right-handed spiral is shown.

[0145] Figure 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the face mask.

[0146] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0147] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The direction of this view is perpendicular to the central contact plane. Figure 3V The sagittal plane in the middle divides the air chamber into two equal parts: the left-hand side and the right-hand side.

[0148] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, which is in Figure 3V A section is shown at the radial plane. The "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of chord 3210, which lies in the sagittal plane and contacts the gasket of the inflation chamber only at two points (upper point 3220 and lower point 3230) in the sagittal plane. Depending on the geometry of the gasket in this area, the intermediate contact plane can be a section at the upper and lower points.

[0149] Figure 3X The location shown is for use on the face. Figure 3U The air chamber 3200. When the air chamber is in the use position, the sagittal plane of the air chamber 3200 substantially coincides with the central sagittal plane of the face. When the air chamber is in the use position, the intermediate contact plane generally corresponds to the "plane of the face". Figure 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is roughly located on the bridge of the nose, while the lower point 3230 is located on the upper part of the lip.

[0150] Figure 3Y A patient interface in the form of a nasal cannula according to the present technology is shown.

[0151] Figure 3Z A patient interface with a catheter tip cap, according to this technology, is shown.

[0152] RPT device

[0153] Figure 4AAn RPT device of one form according to the present technology is shown.

[0154] Figure 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface as downstream of the blower, regardless of the actual flow direction at any given moment. Objects located within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0155] humidifier

[0156] Figure 5A An isometric view of one form of humidifier according to the present technology is shown.

[0157] Figure 5B An isometric view of a humidifier according to the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0158] Textile coverings

[0159] Figure 6A A cross-sectional view of a type of cushioning material according to the present technology is shown.

[0160] Modularity

[0161] Figure 7A A perspective view of the padding of a patient interface is shown, which is configured to be worn by a patient and deliver pressurized air to the patient's nose and mouth.

[0162] Figure 7B A perspective view of the padding of a patient interface is shown, which is configured to be worn by a patient and deliver pressurized air to the patient's nose.

[0163] Figure 7C It shows that it can be used with Figure 7A padding or Figure 7B A perspective view of the tube used with the liner.

[0164] Figure 7D It shows that it can be used with Figure 7A padding or Figure 7B A perspective view of the hardener arm used with the padding.

[0165] Figure 7E It shows that it can be used with Figure 7A A perspective view of the headgear strap used with padding.

[0166] Figure 7F It shows that it can be used with Figure 7BA perspective view of the headgear strap used with padding.

[0167] Figure 7G It shows removable assembly to Figure 7C pipe or Figure 7D Front view of a pair of sleeves on the hardener arm.

[0168] Figure 7H It shows removable assembly to Figure 7D Front view of the complete sleeve of the hardener arm.

[0169] Figure 7I It shows removable assembly to Figure 7D A front perspective view of another alternative form of the complete sleeve of the hardener arm.

[0170] Figure 7J It is worn connected to Figure 7C pipe, Figure 7E headgear and Figure 7G The sleeve Figure 7A A front view of the patient with the padding.

[0171] Figure 7K It is worn connected to Figure 7D hardener arm, Figure 7E headgear and Figure 7H The sleeve Figure 7A A front view of the patient with the padding.

[0172] Figure 7L It is worn connected to Figure 7C catheter head cover and Figure 7F The headgear Figure 7B A front view of the patient with the padding.

[0173] Figure 7M It is worn connected to Figure 7D hardener arm, Figure 7F headgear and Figure 7I The sleeve Figure 7B A front view of the patient with the padding.

[0174] Figure 7N yes Figure 7L A perspective view of the vent.

[0175] Figure 7O yes Figure 7M A separate perspective view of a portion of the air circuit.

[0176] Figure 7P This is a schematic diagram illustrating possible combinations of the patient interface. Detailed Implementation

[0177] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific instances described herein, and the specific instances described herein may vary. It should also be understood that the terminology used in this invention is for the purpose of describing the specific instances discussed herein and is not intended to be limiting.

[0178] The following description is provided for 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. Furthermore, any single feature or combination of features in any instance may constitute another instance.

[0179] therapy

[0180] In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the inlet of the airway of a patient 1000.

[0181] In some instances of this technology, positive pressure air is supplied to the patient’s nasal passages via one or both nostrils.

[0182] In some instances of this technology, mouth breathing is restricted, constrained, or prevented.

[0183] Respiratory therapy system

[0184] In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0185] Patient Interface

[0186] According to one aspect of this technology, such as Figure 3A The illustrated noninvasive patient interface 3000 includes the following functional aspects: a seal-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connecting to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the inlet of the patient's airway to maintain positive pressure at the airway inlet of the patient 1000. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0187] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, then the patient interface may not be suitable for respiratory pressure therapy.

[0188] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure higher than that of the ambient environment, for example, at least 2, 4, 6, 10 or 20 cmH2O relative to the ambient environment.

[0189] Sealing Formation Structure

[0190] 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 sealing may occur. The actual area where sealing occurs—the actual sealing surface—can vary over time and from patient to patient within a given treatment session, depending on a range of factors, including, for example, the placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0191] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0192] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material, such as silicone rubber.

[0193] The sealing structure 3100 according to this technology can be made of a soft, flexible, elastic material (such as silicone).

[0194] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each sealing formation structure 3100 being configured to correspond to a different range of sizes and / or shapes. For example, the system may include one type of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, while another sealing formation structure is suitable for small-sized heads but not for large-sized heads.

[0195] Sealing mechanism

[0196] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to the positive system pressure acting on its underside within the inflation chamber 3200, causing it to achieve a tight, sealed engagement with the face. The pressure-assisted mechanism can function in conjunction with elastic tension in the positioning and stabilizing structure.

[0197] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends at least partially around the periphery. The support flange is a spring-like element or includes a spring-like element and serves to support the sealing flange and prevent it from bending during use.

[0198] 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.

[0199] In one form, the sealing structure includes a tensioning portion. In use, this tensioning portion is maintained tension, for example, by a region adjacent to the sealing flange.

[0200] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0201] 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 tensioning portion, and a portion having an adhesive or bonding surface.

[0202] bridge or ridge of the nose

[0203] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the bridge or ridge of the nose of the patient's face during use.

[0204] In one form, the seal-forming structure includes a saddle-shaped area configured to form a seal on the bridge of the nose or the ridge of the nose of a patient's face during use.

[0205] upper lip area

[0206] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face during use.

[0207] In one form, the seal-forming structure includes a saddle-shaped area configured to form a seal on the upper lip area of ​​a patient's face during use.

[0208] Chin area

[0209] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the chin area of ​​the patient's face during use.

[0210] In one form, the seal-forming structure includes a saddle-shaped area configured to form a seal on the chin area of ​​a patient's face during use.

[0211] Forehead area

[0212] 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.

[0213] nose pillow

[0214] In one form, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal flaps or nasal pillows, each of which is constructed and arranged to form a seal with the corresponding nostril of the patient's nose.

[0215] A nasal pillow according to one aspect of the present invention includes: a truncated cone, at least a portion of which forms a seal on the underside of the patient's nose; a handle; and a flexible region located on the underside of the truncated cone and 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 the base of the handle. These flexible regions can work together to facilitate a universal joint structure that accommodates relative displacement and angular movement of the truncated cone and the structure to which the nasal pillow is connected. For example, the truncated cone can be axially displaced toward the structure to which the handle is connected.

[0216] Pure nose mask

[0217] In one form, the patient interface 3000 includes a sealing structure 3100 configured to seal around the inlet of the patient's nasal airway rather than around the patient's mouth. The sealing structure 3100 can be configured to seal against the patient's upper lip. The patient interface 3000 allows the patient's mouth to remain uncovered. This patient interface 3000 can deliver a supply of air or breathable gas to both nostrils of the patient 1000 without delivering it to the mouth. This type of patient interface can be identified as a nasal mask only.

[0218] One form of the pure nasal mask according to the present technology is one conventionally recognized as a nasal mask, having a sealing forming structure 3100 configured to surround the nose on the patient's face and seal over the bridge of the nose. The shape of the nasal mask may be generally triangular. In one form, the non-invasive patient interface 3000 includes the sealing forming structure 3100, which, in use, forms a seal against the upper lip region (e.g., the upper lip), against the patient's bridge of the nose or at least a portion of the nasal ridge above the nasal protuberance, and against the patient's face on each lateral side of the nose (e.g., near the patient's nasolabial fold). Figure 1B The patient interface 3000 shown has this type of sealing structure 3100. The patient interface 3000 can deliver a supply of air or breathable gas to the two nostrils of the patient 1000 through a single orifice.

[0219] Another form of a pure nasal mask can seal around the lower periphery of a patient's nose without engaging the user's nasal ridge. For example, this type of patient interface 3000 can be identified as a "nose pad" mask, and the sealing forming structure 3100 can be identified as a "nose pad". In one form, the sealing forming structure 3100 is configured to form a seal with the lower surface of the nose surrounding the nostrils during use. The sealing forming structure 3100 can be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including sealing the lower and / or anterior surfaces of the nasal protuberance region of the patient's nose and sealing the patient's nasal wings. The sealing forming structure 3100 can seal to the upper part of the patient's lips. The shape of the sealing forming structure 3100 can be configured to match or closely fit the lower side of the patient's nose and may not contact the nasal bridge region of the patient's nose or any part of the patient's nose above the nasal protuberance. In one form of nose pad, the sealing forming structure 3100 includes a bridging portion that divides the opening into two orifices, each orifice supplying air or breathable gas to a corresponding patient nostril during use. The bridging portion can be configured to contact or abut against the patient's columella during use for sealing. Alternatively, the seal-forming structure 3100 may include a single opening to provide airflow or breathable gas to both of the patient's nostrils.

[0220] In some forms, a simple nasal mask may include a nasal pillow as described above.

[0221] Nose and mouth mask

[0222] In one embodiment, the patient interface 3000 includes a sealing structure 3100 configured to seal around an inlet to the patient's nasal airway and around the patient's mouth. The sealing structure 3100 may be configured to seal against the patient's face near the chin area. The patient interface 3000 can deliver a supply of air or breathable gas to the nostrils and mouth of the patient 1000. This type of patient interface can be identified as a nasogastric mask.

[0223] One form of the nose and mouth mask according to the present technology is conventionally recognized as a full-face mask, having a sealing formation 3100 configured to seal around the nose, below the mouth, and above the bridge of the nose on the patient's face. The nose and mouth mask may be generally triangular in shape. In one form, the patient interface 3000 includes the sealing formation 3100, which, in use, forms a seal over the patient's chin area (which may include the patient's lower lip and / or the area directly below the lower lip), at least a portion of the patient's bridge or ridge of the nose above the nasal protuberance, and the cheek area of ​​the patient's face. Figure 1C The patient interface 3000 shown belongs to this type. This patient interface 3000 can deliver a supply of air or breathable gas to the nostrils and mouth of the patient 1000 through a single orifice. This type of sealing structure 3100 can be referred to as a nose / mouth liner.

[0224] In another form, the patient interface 3000 includes a sealing structure 3100 that, in use, forms a seal on the lower and / or anterior surface of the nasal projection portion of the patient's nose, the nasal alae of the patient's nose, and the patient's face on each lateral side of the patient's nose (e.g., near the nasolabial fold) in the patient's chin area (which may include the patient's lower lip and / or the area directly below the lower lip). The sealing structure 3100 may also form a seal against the patient's upper lip. A patient interface 3000 of this type may have a single opening configured to deliver an airflow or breathable gas to the patient's two nostrils and mouth; may have an orifice configured to deliver air or breathable gas to the mouth and nostrils configured to deliver air or breathable gas to the nostrils; or may have an orifice for delivering air to the patient's mouth and two nostrils for delivering air to the corresponding nostrils. This type of patient interface 3000 may have a nasal portion and a mouth portion, the nasal portion being sealed to the patient's face in a location similar to a nose pad.

[0225] In another form of the nasal mask, the patient interface 3000 may include a sealing formation 3100 having a nasal portion including a nasal pillow and an oral portion configured to form a seal on the patient's face around the patient's mouth.

[0226] In some forms, the sealing structure 3100 may have a nasal portion that is separate from and distinct from the mouth portion. In other forms, the sealing structure 3100 may form a continuous seal around the patient's nose and mouth.

[0227] It should be understood that the above instances of different forms of patient interface 3000 do not constitute an exhaustive list of possible configurations. In some forms, patient interface 3000 may include combinations of different features of the above instances of pure nasal mask and naso-oral mask.

[0228] Inflation chamber

[0229] The inflation chamber 3200 has a periphery whose shape is configured to complement the surface contour of a typical face in the area where a seal will be formed during use. In use, the boundary edges of the inflation chamber 3200 are positioned close to the adjacent surface of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 may extend around the entire periphery of the inflation chamber 3200 during use. In some forms, the inflation chamber 3200 and the sealing structure 3100 are formed from a single sheet of homogeneous material.

[0230] In some forms of this technology, the air chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the air chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve adherence to therapy.

[0231] In some forms of this technology, the air chamber 3200 is made of a transparent material (e.g., transparent polycarbonate). Using a transparent material reduces the obtrusiveness of the patient interface and helps improve adherence to the therapy. Using a transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0232] In some forms of this technology, the air chamber 3200 is made of a translucent material. Using a translucent material can reduce the obtrusiveness of the patient interface and help improve adherence to the therapy.

[0233] In some configurations, the air chamber 3200 is made of a rigid material such as polycarbonate. This rigid material can provide support for the sealing structure.

[0234] In some forms, the air chamber 3200 is made of a flexible material (e.g., a soft, flexible, elastic material such as silicone, textiles, foam, etc.). For example, in one instance, it could then be formed of a material with a Young's modulus of 0.4 GPa or lower (e.g., foam). In some forms of this technology, the air chamber 3200 can be made of a material with a Young's modulus of 0.1 GPa or lower (e.g., rubber). In other forms of this technology, the air chamber 3200 can be made of a material with a Young's modulus of 0.7 MPa or less, for example, a material between 0.7 MPa and 0.3 MPa. An example of such a material is silicone.

[0235] Multiple openings

[0236] like Figure 7A and Figure 7B As shown, different air chambers 3200-1, 3200-2 can be formed as part of multi-opening liners 3050-1, 3050-2. In the illustrated example, liners 3050-1, 3050-2 each include three openings, although alternative liners can be formed with more or fewer openings.

[0237] In some forms, different openings can serve different purposes. For example, some openings may be simply entrance openings, while others may be simply exit openings.

[0238] In other forms, at least one opening can provide two different functions. For example, during the same respiratory cycle, an opening can function as both an inlet and an outlet.

[0239] These multiple openings allow for various configurations of air delivery into the inflation chambers 3200-1, 3200-2. For example, depending on patient needs and / or patient comfort, a given liner 3050-1, 3050-2 may be used in an “upper tube” configuration (e.g., using a catheter head cap as described below) or a “lower tube” configuration (e.g., using a single catheter positioned in front of the patient’s face).

[0240] Nose and mouth mask

[0241] like Figure 7A As shown, the inflation chamber 3200-1 includes a pair of inflation chamber inlet ports 3254-1, which can be used to deliver gas into and / or out of the inflation chamber 3200-1. The inflation chamber inlet ports 3254-1 can be located on opposite sides of the inflation chamber 3200-1 (e.g., left and right sides).

[0242] In some forms, the inflation chamber 3200-1 may also include at least one ventilation opening 3402-1 (see example...) Figure 7AThe vent opening 3402-1 can be located at the center of the inflation chamber 3200-1. For example, the vent opening 3402-1 can be located between the inlet ports 3254-1 of the inflation chamber.

[0243] In some forms, the inflation chamber 3200-1 may include a pair of recesses 3266-1. Each recess 3266-1 may be located near one of the inflation chamber inlet ports 3254-1. Each recess 3266-1 may form a partially recessed surface.

[0244] Pure nose mask

[0245] The air chamber 3200-2 of the pure nasal liner 3050-2 can be similar to the air chamber 3200-1 of the mouth and nose liner 3050-1. The following describes only some similarities and differences between the air chambers 3200-1 and 3200-2.

[0246] like Figure 7B As shown, the inflation chamber 3200-2 includes a pair of inflation chamber inlet ports 3254-2, which can be used to deliver gas into and / or out of the inflation chamber 3200-2. The inflation chamber inlet ports 3254-2 can be located on opposite sides of the inflation chamber 3200-2 (e.g., left and right sides).

[0247] In some forms, the air chamber 3200-2 may also include at least one vent opening 3402-2 (see example...) Figure 7B The vent opening 3402-2 can be located at the center of the inflation chamber 3200-2. For example, the vent opening 3402-2 can be located between the inlet ports 3254-2 of the inflation chamber.

[0248] In some forms, the inflation chamber 3200-2 may include a pair of recesses 3266-2. Each recess 3266-2 may be located near one of the inflation chamber inlet ports 3254-2. Each recess 3266-2 may form a partially recessed surface.

[0249] Positioning and stabilizing structure

[0250] The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by a positioning and stabilizing structure 3300. The positioning and stabilizing structure 3300 may include and function as a "headgear" because the "headgear" engages with the patient's head to hold the patient interface 3000 in a sealed position. Figure 3A An example of a positioning and stabilizing structure is shown in the figure.

[0251] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure in the inflation chamber 3200 to lift the face away (i.e., F). 充气 ).

[0252] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the effects of gravity on the patient interface 3000.

[0253] In some forms, the sum of all forces can equal zero, so that the patient interface 3000 is in equilibrium (e.g., does not move along the patient's face during use). Specifically, gravity F g and blowing force F 充气 The tendency is to move the seal-forming structure 3100 away from the desired sealing position. Positioning and stabilizing forces FPSS are applied to counteract the gravitational force F. g and blowing force F 充气 (and any frictional force F) f And maintain the proper positioning of the sealing structure 3100. Despite the positioning and stabilizing force F PSS Possibly exceeding gravity F g and blowing force F 充气 The sum of (where any additional positioning and stabilizing forces F) PSS The reaction force from the patient's head acting on a portion of the patient interface 3000 balances the seal (and still maintains the sealing structure 3100 in the proper sealing position), but this may sacrifice patient comfort. Maximum patient comfort can be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilizing force FPSS is just strong enough to achieve this. In some instances, the positioning and stabilizing structure 3300 can be adjustable such that, when assembled, the positioning and stabilizing force FPSS is greater than the precise balancing gravity F. g and blowing force F 充气 The required force is sufficient to hold the patient interface 3000 firmly against the patient's head so that destructive forces that may be experienced during use (such as tube resistance or lateral shunting of the inflation chamber 3200 during lateral recumbency) do not break the seal. As described below, various positions of the patient's head when using the patient interface 3000 determine the positioning and stabilizing force FPSS required to achieve balance.

[0254] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential impact of disturbance forces on the patient interface 3000, such as those from tube resistance or unintended interference with the patient interface.

[0255] In one form of this technology, a positioning and stabilizing structure 3300 is provided, configured to be worn by a patient while sleeping. In one instance, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one instance, the positioning and stabilizing structure 3300 includes at least one strip with a rectangular cross-section. In one instance, the positioning and stabilizing structure 3300 includes at least one flat strip.

[0256] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured not to be too large or too bulky to prevent the patient from lying in a supine sleeping position, wherein the back area of ​​the patient's head rests on a pillow.

[0257] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured not to be too large or too bulky to prevent the patient from lying in a side-lying position, wherein the side area of ​​the patient's head rests on a pillow.

[0258] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a disengaging connection portion located between the front portion and the rear portion of the positioning and stabilizing structure 3300. The disengaging connection portion does not resist compression and may be, for example, a flexible band or soft band. The disengaging connection portion is constructed and arranged such that when the patient rests their head on the pillow, the presence of the disengaging connection portion prevents forces on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0259] In one form of this technology, the positioning and stabilizing structure 3300 includes a strip constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strip. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0260] In some forms of this technology, the positioning and stabilizing structure 3300 includes an extendable band, such as a resiliently extendable band. For example, the band can be configured to be tensioned during use, and the guiding force causes the sealing structure to make sealing contact with a portion of the patient's face. In an example, the band can be configured as a tie.

[0261] In one form of the technology, the positioning and stabilizing structure includes a first frenulum that is constructed and arranged such that, in use, at least a portion of its lower edge passes over the supraauricular base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0262] In one form of this technology applicable to a pure nasal mask or a full face mask, the positioning and stabilizing structure includes a second strap that is configured and arranged such that, in use, at least a portion of its upper edge passes below the subauricular base of the patient's head and covers or is located below the occipital bone of the patient's head.

[0263] In one form of the technology applicable to nasal masks only or to full-face masks, the positioning and stabilizing structure includes a third strap that is configured and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.

[0264] In some forms of this technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. An advantage of this is that the strap is more comfortable for the patient when they are sleeping.

[0265] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strip configured to be breathable to allow moisture to pass through it.

[0266] In some forms of this technology, a system is provided comprising 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 type of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, while another positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0267] catheter head cover

[0268] catheter head sleeve

[0269] In some forms of this technology, the positioning and stabilization structure 3300 includes one or more head tubes 3350 that deliver pressurized air from the RPT device to the patient's airway, for example, through an inflation chamber 3200 and a sealing formation 3100. Figure 3Z In the illustrated form of the present technology, the positioning and stabilizing structure 3300 includes two tubes 3350 for delivering air from the air circuit 4170 to the inflation chamber 3200. The tubes 3350 are configured to, in use, position and stabilize the sealing formation 3100 of the patient interface 3000 at an appropriate portion of the patient's face (e.g., the nose and / or mouth). This allows the conduit of the air circuit 4170, which provides pressurized airflow, to connect to the connection port 3600 of the patient interface at a location other than in front of the patient's face (e.g., on the top of the patient's head).

[0270] exist Figure 3Z In the illustrated form of the present technology, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 positioned on a different side of the patient's head during use, and extending above the corresponding ear (above an auricular base point above the patient's head) across the corresponding cheek area to a curved tube 3610 on the top of the patient's head. This form of the technology may be advantageous because if the patient sleeps with their head turned to the side, and one tube 3350 is compressed to block or partially block the gas flow along that tube 3350, the other tube 3350 remains open to supply pressurized gas to the patient. In other instances of the technology, the patient interface 3000 may include a different number of tubes, such as one tube, or two or more tubes.

[0271] In one example where the patient interface has a tube 3350, the single tube 3350 is positioned on one side of the patient's head during use (e.g., across a cheek area), and the band forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head during use (e.g., across another area) to help secure the patient interface 3000 to the patient's head. For example, the tube 3350 and the band may each be under tension during use to help maintain the sealing structure 3100 in a sealed position.

[0272] In one embodiment, the tube 3350 may be at least partially extendable, allowing the tube 3350 and the band to be adjusted to approximately equal lengths when worn by a patient. This allows for substantially symmetrical adjustment between the tube 3350 and the band, ensuring that the sealing structure remains substantially centered.

[0273] exist Figure 3Z In the illustrated embodiment, two tubes 3350 are fluidly connected to each other at their upper ends and to a connection port 3600. In some instances, the two tubes 3350 are formed integrally, while in others, the tubes 3350 are formed separately but connected in use and can be disconnected, for example, for cleaning or storage. When using separate tubes, they can be indirectly connected together, for example, each can be connected to a T-connector. The T-connector may have two arms / branches, each fluidly connected to a corresponding one of the tubes 3350. Additionally, the T-connector may have a third arm or opening providing a connection port 3600 for fluid connection to the air circuit 4170 in use. This opening may be an inlet 3332 for receiving a pressurized airflow (see, for example, 7C).

[0274] In some forms, the third arm of a T-connector can be substantially perpendicular to each of the first two arms.

[0275] In some forms, the third arm of a T-connector can be formed at an angle relative to each of the first two arms.

[0276] In some forms, a Y-shaped connector can be used instead of a T-shaped connector. The first two arms can be tilted relative to each other, and the third arm can be tilted relative to the first two arms. The angled first two arms can resemble the shape of the patient's head to conform to that shape.

[0277] In some forms, at least one arm of the T-connector (or Y-connector) can be flexible. This allows the connector to bend based on the shape of the patient's head and / or the forces in the positioning and stabilizing structure 3300.

[0278] In some forms, at least one arm of a T-connector (or Y-connector) can be at least partially rigidified. This helps maintain the shape of the connector so that bending of the connector does not block the airflow path.

[0279] Tube 3350 may be formed from a flexible material (such as an elastomer, e.g., silicone or TPE), and / or from one or more textile and / or foam materials. Tube 3350 may have a pre-formed shape and be able to bend or move into another shape when a force is applied, but can return to the original pre-formed shape when the force is not applied. Tube 3350 may be generally arched or curved, its shape approximating the contour of a patient's head between the top of the head and the nasal or oral region.

[0280] In some instances, the one or more tubes 3350 are compression-resistant to prevent blockage if compressed during use (e.g., if pressed between a patient's head and a pillow, especially if only one tube 3350 is present). The tube 3350 may be configured to have sufficient structural rigidity to resist compression, or may be as described in U.S. Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0281] Each tube 3350 can be configured to receive an airflow from a connection port 3600 on the top of the patient's head and deliver that airflow to a sealing structure 3100 at the entrance to the patient's airway. Figure 3ZIn the example shown, each tube 3350 is positioned in use along a path extending from the inflation chamber 3200 across the patient's cheek area and above the patient's ear to the curved tube 3610. For example, the portion of each tube 3350 near the inflation chamber 3200 may cover the maxillary region of the patient's head in use. Another portion of each tube 3350 may cover the area of ​​the patient's head above the supraacular base point. Each tube 3350 may also be positioned over any or both of the patient's sphenoid and / or temporal bones, and the patient's frontal and parietal bones. The curved tube 3610 may be positioned in use above the patient's parietal bone, above the frontal bone, and / or above the junction between them (e.g., the coronal suture).

[0282] In some forms of this technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned across the top of the patient's head, allowing the patient interface 3000 to be positioned to suit the comfort or fit of an individual patient. In some instances, the headgear 3350 is configured to allow the upper portion of the patient interface 3000 (e.g., the connection port 3600) to move relative to the lower portion of the patient interface 3000 (e.g., the inflation chamber 3200). That is, the connection port 3600 can be at least partially disengaged from the inflation chamber 3200. Thus, the sealing structure 3100 can form an effective seal with the patient's face, regardless of the position of the connection port 3600 on the patient's head (at least within a predetermined position range).

[0283] As described above, in some embodiments of this technology, the patient interface 3000 includes a sealing-forming structure 3100 in the form of a pad, which is typically located below the nose and seals to the lower periphery of the nose (e.g., a liner under the nose). A positioning and stabilizing structure 3300, including a tube 3350, can be configured and arranged to pull the sealing-forming structure 3100 below the nose into the patient's face using a rearward and upward (e.g., posterosuperior) sealing force. The posterosuperior sealing force allows the sealing-forming structure 3100 to form a good seal against the lower periphery of the patient's nose and the forward-facing surfaces of the patient's face, such as on either side of the patient's nose and above the patient's lips.

[0284] The catheter, such as the headband, which forms part of the positioning and stabilizing structure 3300, can provide forces that help position and stabilize the FPSS.

[0285] In some forms, when the catheter is filled with pressurized air, it can provide a force directed towards the patient's head. This force helps to clamp the patient's head. This force can be caused by the inflation of the catheter during normal use. In some forms, this force can provide cushioning for the patient's head. The catheter can be designed to limit expansion to prevent excessive clamping of the patient's head.

[0286] The position of the patient's head can also change the clamping force of the catheters. For example, if the patient is lying on their side, the weight of the patient's head may compress one catheter, and another catheter (e.g., the outer portion not between the patient's head and the sleeping surface, such as a pillow) may additionally expand in order to maintain substantially the same pressurized airflow.

[0287] Gravity F g It can be related to frictional force F f Conversely, this frictional force can be directly related to gravity F. g The forces act in the opposite direction. When gravity pulls the sealing structure 3100 and the air chamber 3200 downwards, the frictional force F... f It will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F on the upper part of their lips (and / or other surfaces of the patient's face that are in contact with the seal-forming structure 3100). f This is to counteract downward movement (which helps stabilize the pad in place). Despite the frictional force F... f Specifically shown as the gravity F of the sealing structure 3100 and the inflation chamber 3200 g Conversely, but the component of the total frictional force (not shown) will also be associated with the gravitational force F of any other part of the positioning and stabilizing structure 3300 and the patient interface 3000. g Relatively speaking, friction can act at any point along the patient interface 3000 where it contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair).

[0288] In some forms, the sum of all forces can equal zero, so that the patient interface 3000 is in equilibrium (e.g., does not move along the patient's face during use). Specifically, gravity F g and blowing force F 充气 The tendency is to move the seal-forming structure 3100 away from the desired sealing position. Positioning and stabilizing forces FPSS are applied to counteract the gravitational force F. g and blowing force F 充气 (and any frictional force F) f And maintain the seal forming structure 3100 correctly positioned. Although the positioning and stabilizing force FPSS may exceed the gravitational force F g and blowing force F 充气The sum of the forces (where any additional positioning and stabilizing forces FPSS are balanced by the reaction forces from the patient's head acting on the portion of the patient interface 3000) still maintains the seal-forming structure 3100 in the proper sealed position, but may sacrifice patient comfort. Maximum patient comfort can be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilizing forces FPSS are just strong enough to achieve this. In some instances, the positioning and stabilizing structure 3300 can be adjustable such that, when assembled, the positioning and stabilizing forces FPSS are greater than the precisely balancing gravity F. g and blowing force F 充气 The required force is sufficient to hold the patient interface 3000 firmly against the patient's head so that destructive forces that may be experienced during use (such as tube resistance or lateral shunting of the inflation chamber 3200 during lateral recumbency) do not break the seal. As described below, various positions of the patient's head when using the patient interface 3000 determine the positioning and stabilizing force FPSS required to achieve balance.

[0289] Extendable and non-extendable tube sections

[0290] In some embodiments of this technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tubes 3350 may include one or more extendable tube segments (e.g., formed by an extendable accordion-like structure). In some forms, the patient interface 3000 may include a positioning and stabilizing structure 3300 comprising at least one gas delivery tube having a tube wall having an extendable accordion-like structure. Figure 3Z The patient interface 3000 shown includes a tube 3350, the upper portion of which includes extendable tube sections, each in the form of an extendable accordion structure 3362.

[0291] In some forms, the extendable accordion structure 3328 can be formed as a series of ridges and grooves on the surface of the tube 3350. The accordion structure 3328 can be biased toward a constricted position and can move to an extended position when the patient wears the positioning and stabilizing structure 3300. Because portions of the tube 3350 can be substantially non-extendable (e.g., non-extendable tube segment 3363), the accordion structure 3328 allows the positioning and stabilizing structure 3300 to stretch to fit different head sizes. This allows a single-size tube 3350 to be used with multiple head sizes. For example, because of the accordion structure 3328, the positioning and stabilizing structure 3300 can be “universal.” Alternatively, the tube 3350 can be manufactured in multiple sizes (e.g., small, medium, large). The patient can choose the length that best fits their head, and the accordion structure 3328 can be slightly adjusted to accommodate a fit for an individual patient.

[0292] In some configurations, inlet 3332 may be located in the middle of conduit 6320. For example, conduit 3350 may be symmetrical about inlet 3332 via at least one axis.

[0293] The cross-sectional shape of the non-extendable tube segment 3363 of tube 3350 can be circular, elliptical, oval, D-shaped, or rounded rectangular, for example, as described in U.S. Patent No. 6,044,844. A cross-sectional shape that presents a flattened surface of the tube on the side facing and contacting the patient's face or other parts of the head may be more comfortable to wear than, for example, a tube with a circular cross-section.

[0294] In some embodiments of this technology, the non-extendable tube segment 3363 connects to the inflation chamber 3200 at a low angle. The headgear tube 3350 may extend downwards along both sides of the patient's head and then bend forward and inwards to connect to the inflation chamber 3200 in front of the patient's face. Before connecting to the inflation chamber 3200, the tube 3350 may extend to the same vertical position as the connection point with the inflation chamber 3200 (or, in some embodiments, below the connection point with the inflation chamber 3200). That is, the tube 3350 may protrude at least partially upwards before connecting to the inflation chamber 3200. A portion of the tube 3350 may be located below the inflation chamber 3200 and / or the sealing forming structure 3100. The tube 3350 may contact the patient's face below the cheekbone, which may be more comfortable than contacting the patient's cheekbone and may avoid excessively obscuring the patient's peripheral vision.

[0295] catheter head connection port

[0296] In some forms of this technology, the patient interface 3000 may include a connection port 3600 located near the upper, outer, or rear portion of the patient's head. For example, in Figure 3Z In the illustrated form of the present technology, the connection port 3600 is located on top of the patient's head (e.g., at an overhead position relative to the patient's head). In this example, the patient interface 3000 includes a bend 3610 forming the connection port 3600. The bend 3610 can be configured to be in fluid connection with a conduit of the air circuit 4170. The bend 3610 can be configured to rotate relative to the positioning and stabilizing structure 3300 to at least partially disengage the conduit from the positioning and stabilizing structure 3300. In some instances, the bend 3610 can be configured to rotate by rotating about a substantially vertical axis, and in some specific instances, by rotating about two or more axes. In some instances, the bend can include a tube 3350 or be connected to the tube 3350 via a ball-and-socket joint. In use, the connection port 3600 can be located in the sagittal plane of the patient's head.

[0297] Patient interfaces with a connection port not positioned in front of the patient's face may be advantageous because some patients may find catheters connected to a patient interface in front of the patient's face unsightly and / or obtrusive. For example, a catheter connected to a patient interface in front of the patient's face may easily interfere with bedding or linens, especially if the catheter extends downward from the patient interface during use. Forms of this technology that include patient interfaces with a connection port positioned above the patient's head during use can make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: lateral position, supine position (e.g., on their back, typically facing upward), or prone position (e.g., on their front, typically facing downward). Furthermore, connecting the catheter to the front portion of the patient interface may exacerbate a problem known as tube resistance, where the catheter exerts undesirable forces on the patient interface during movement of the patient's head or the catheter, causing displacement away from the face. Tube resistance may not be a problem when forces are received in a position above the patient's head rather than in front of the patient's face, where tube resistance is more likely to disrupt the seal.

[0298] Head sleeve fluid connection

[0299] Two tubes 3350 are fluidly connected at their lower ends to an inflation chamber 3200. In some forms of this technology, the connection between the tubes 3350 and the inflation chamber 3200 is achieved through the connection of two rigid connectors. The tubes 3350 and the inflation chamber 3200 can be configured to allow the patient to easily and reliably connect the two components together. The tubes 3350 and the inflation chamber 3200 can be configured to provide tactile and / or auditory feedback in the form of a reassuring click or similar sound, allowing the patient to easily know that each tube 3350 has been correctly connected to the inflation chamber 3200. In one form, the tubes 3350 are formed of silicone or textile material, and the lower end of each silicone tube 3350 is overmolded to a rigid connector made of, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector on each tube 3350 may include a concave mating feature configured to engage with a convex mating feature on the inflation chamber 3200. Alternatively, the rigid connector on each tube 3350 may include a convex mating feature configured to connect to a concave mating feature on the inflation chamber 3200. In other instances, each tube 3350 may include a convex or concave connector formed of a flexible material, such as silicone or TPE, for example, the same material forming the tube 3350.

[0300] In other instances, compression seals are used to connect each tube 3350 to the inflation chamber 3200. For example, a resilient flexible (e.g., silicone) tube 3350 without a rigid connector can be configured to be compressed to reduce its diameter, such that the resilient flexible tube 3350 can be compressed into a port in the inflation chamber 3200, and the inherent resilience of the silicone pushes the tube 3350 outward to seal the tube 3350 in the port in an airtight manner. Alternatively, in a hard-on-hard engagement between the tube 3350 and the inflation chamber 3200, each tube 3350 and / or inflation chamber 3200 may include a pressure-activated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange can be pushed against the junction between the tube and the circumferential surface of the port or connector surrounding the inflation chamber 3200 to form or reinforce a seal between the tube 3350 and the inflation chamber 3200.

[0301] Headband

[0302] In some forms, the positioning and stabilizing structure 3300 may include a headgear 3302 having at least one strap that can be worn by a patient to help properly orient the sealing structure 3100 against the patient's face (e.g., to limit or prevent leakage).

[0303] As described above, some forms of the headgear 3302 may be made of a textile material that can comfortably conform to the patient's skin. The textile can be flexible to conform to various facial contours. While the textile may include a hardener along a selected length, this can limit the bending, flexing, and / or stretching of the headgear 3302.

[0304] In some forms, the hood 3302 may be at least partially stretchable. For example, the hood 3302 may comprise an elastic or similarly stretchable material. For example, the entire hood 3302 may be stretchable, or selected portions may be stretchable (or more stretchable than the surrounding portions). This allows the hood 3302 to stretch under tension, which can help provide a sealing force for the seal-forming structure 3100.

[0305] Two types of headgear, the four-point headgear 3302-1 and the two-point headgear 3302-2, are discussed in more detail below as illustrative examples.

[0306] Four points connected

[0307] like Figure 7E As shown, some forms of the headgear 3302-1 can be a four-point connection headgear. This means that the headgear 3302-1 can be connected to four separate locations on the inflation chamber 3200, to the frame of the inflation chamber 3200, and / or to the arm of the inflation chamber 3200. The headgear 3302-1 may include four different straps that provide tension to help maintain the sealing formation 3100 in the sealed position. Figure 3A The positioning and stabilizing structure of the 3300 can also be considered as a four-point connection headgear.

[0308] In some forms, the headgear 3302-1 may include a lower band 3304-1, which may be attached to the lower portion of the padding 3050-1. The lower band 3304-1 may extend along the patient's cheek toward the back of the patient's head. For example, the lower band 3304-1 may cover the masseter muscle on either side of the patient's face. Therefore, the lower band 3304-1 may contact the patient's head below the ear. The lower band 3304-1 may meet at the back of the patient's head and may cover the occipital bone and / or trapezius muscle.

[0309] The headgear 3302-1 may also include an upper band 3305-1 that can cover the temporal bone, parietal bone, and / or occipital bone. The upper band 3305-1 may also be connected to the tube 3350 (e.g., by abutting against the flap 3320).

[0310] The posterior strap 3307-1 can extend between the upper strap 3305-1 and the lower strap 3304-1. The lower strap 3304-1 and upper strap 3305-1 on a given side (e.g., left or right) are also connected to the adjacent posterior strap 3307-1. Therefore, the height of the posterior strap 3307-1 can be approximately the combined height of the lower strap 3304-1 and upper strap 3305-1. When in use, the posterior strap 3307-1 can cover the occipital and / or parietal bones. This allows the posterior strap 3307-1 to help anchor the headgear 3302-1 to the patient's head.

[0311] In the illustrated example, the headband 3302-1 can be formed in a generally X shape. The lower band 3304-1 and the upper band 3305-1 can be attached to the rear band 3307-1 using stitching, ultrasonic welding, or any similar process.

[0312] In some configurations, the lower band 3304-1 is connected to the magnetic member 3306-1. For example, each lower band 3304-1 may pass through the magnetic member 3306-1, allowing the length of each lower band 3304-1 to be adjusted. The magnetic member 3306-1 may be removably connected to the magnet 3370-1 (described below), allowing the lower band 3304-1 to be disconnected from the inflation chamber 3200, without affecting the length of the lower band 3304-1.

[0313] In some configurations, the top band 3305-1 can be directly connected to the tab 3320 of the tube 3350. The top band 3305-1 can pass through the tab 3320 to adjust the length and control the tension of each top band 3305-1.

[0314] In some configurations, the headgear 3302-1 can be used only with the nose and mouth liner 3050-1 (e.g., because the nose liner 3050-1 alone does not have four connection points). However, the headgear 3302-1 can be used interchangeably with the tube 3350 and the hardener arm 3340.

[0315] Two points connected

[0316] like Figure 7F As shown, some forms of the headgear 3302-2 can be two-point connected headgears. This means that the headgear 3302-2 can be connected to two separate locations.

[0317] In some forms, the headgear 3302-2 may be formed from a continuous sheet of material. In other words, the headgear 3302-2 may not be formed from multiple straps connected (e.g., sewn) together. This may be comfortable for the patient, as they will not come into contact with any seams or joints connecting the different straps. In other forms, the headgear 3302-2 may be formed from multiple straps (e.g., two upper straps, a back strap, etc.) connected together (e.g., by sewing, ultrasonic welding, etc.).

[0318] In some forms of this technology, the positioning and stabilizing structure 3300, in addition to the tube 3350, includes at least one headband for positioning and stabilizing the sealing structure 3100 at the entrance to the patient's airway. Figure 3Z As shown, the patient interface 3000 includes a strap 3307-2 forming part of a positioning and stabilizing structure 3300. For example, the strap 3307-2 may be referred to as a back strap or a posterior headband. The posterior strap 3307-2 may cover the temporal bone, parietal bone, and / or occipital bone. In other embodiments of the present technology, one or more additional straps may be provided. For example, a patient interface 3000 with a nose and mouth pad according to an embodiment of the present technology may have a second lower strap configured to abut against the patient's head near the patient's neck and / or against the posterior surface of the patient's neck.

[0319] exist Figure 3Z In the example shown, the positioning and stabilizing structure 3300 has a band 3310 connected between two tubes 3350 positioned on each side of the patient's head and around the back of the patient's head, for example, covering the occipital bone of the patient's head in use or located below the occipital bone of the patient's head. The band 3310 is connected to each tube above the patient's ear. Reference Figure 3Z The positioning and stabilizing structure 3300 includes a pair of tabs 3320. In use, a strap 3310 can be attached between the tabs 3320. Even when under tension during use, the strap 3310 has sufficient flexibility to wrap around the back of the patient's head and comfortably rest against the patient's head.

[0320] like Figure 7F As shown, some forms of the headgear 3302-2 may be at least partially bifurcated. For example, the rear band 3307-2 of the headgear 3302-2 (e.g., configured to contact the rear portion of the patient's head) may be wider than the surrounding portion of the headgear 3302-2. The middle section 3308-2 of the rear band 3307-2 may include a slit 3309-2. Thus, due to the slit 3309-2, the upper section of the rear band 3307-2 can move relative to the lower section. This allows for greater band coverage over the rear region of the patient's head, which can help to better anchor the headgear 3302-2 to the patient's head, since there is no lower band (e.g., 3304-1).

[0321] In some configurations, the headgear 3302-2 may be used only with the nose pad 3050-2 (e.g., because the nose and mouth pads 3050-1 do not have four connection points). However, the headgear 3302-2 may be used interchangeably with the tube 3350 and the hardener arm 3340.

[0322] hardener arm

[0323] like Figure 7D As shown, the hardening arm 3340 may be an elongated rigid member that helps hold the pad (e.g., nasal and mouth pad 3050-1 or nasal pad 3050-2) in the operating position. The hardening arm 3340 may contact one side of the patient's head and provide force to limit the sliding of the seal-forming structure 3100 from the patient's nose and / or mouth.

[0324] In some forms, the hardening arm 3340 is made of a rigid material (e.g., plastic). A rigid material may not allow the hardening arm 3340 to stretch. Additionally, the hardening arm 3340 may be substantially inflexible and may not be able to bend. The hardening arm 3340 can be pre-molded into a desired shape to conform to the patient's head. For example, the hardening arm 3340 can be molded into a curved shape to roughly correspond to the shape of one side of the patient's head (e.g., covering the masseter muscle and / or temporal bone).

[0325] In some forms, the hardener arm 3340 can be molded to fit the head of a specific patient (e.g., a custom hardener arm 3340).

[0326] In some forms, the hardening arm 3340 may be flexible in at least one direction. For example, the hardening arm 3340 may be flexible about its width and not flexible along its length. In other words, the hardening arm 3340 may bend about an axis along its width, but may not bend about an axis perpendicular to its width. This allows individual patients to adjust the hardening arm 3340 for a better fit to their individual head.

[0327] In some forms, the hardening arm 3340 can remain in its new position after bending. This allows patients to adjust the shape of the hardening arm 3340 to suit their specific head shape, and then the hardening arm 3340 will maintain the desired shape during use to improve patient comfort.

[0328] In some forms, the first end 3342 of the hardening arm 3340 may be a free end, and the second end 3344 of the hardening arm 3340 (e.g., opposite the first end 3342) may be fixed. The first end 3342 may be curved to minimize sharp edges that could cause patient discomfort. In use, the first end 3342 may also cover the patient's head near the temporal bone. The second end 3344 may be fixed to the arm connection structure 3504.

[0329] In some forms, the arm connection structure 3504 can be similar to the conduit connection structure 3500. For example, the arm connection structure 3504 and the conduit connection structure 3500 can have substantially the same shape. This allows the conduit connection structure 3500 or the arm connection structure 3504 to fit into a recess (e.g., 3266-1 or 3266-2) and connect to the inflation chamber inlet port 3254. The arm connection structure 3504 can be connected to the nose liner 3050-1 or the pure nose liner 3050-2 in substantially the same manner as the conduit connection structure 3500 (e.g., via snap-fit, press-fit, friction fit, etc.).

[0330] In some configurations, the arm connection 3504 can serve as a plug for the inflation chamber inlet port 3254 (e.g., 3254-1 and / or 3254-2). Unlike the tube 3350, the hardener arm 3340 does not deliver pressurized air to the inflation chamber 3200. The hardener arm 3340 can be used with a “lower tube” configuration, where a hose connects to a vent opening 3402 (e.g., 3402-1 and / or 3402-2) and delivers air to the inflation chamber 3200 through the vent opening 3402. In this example, air does not need to travel into or out of the inflation chamber inlet opening 3254. Therefore, the arm connection 3504 can form a seal with the inflation chamber inlet opening 3254 to restrict airflow into or out of the inflation chamber 3200.

[0331] Vent

[0332] In one embodiment, the patient interface 3000 includes a ventilation port 3400 that is configured and arranged to allow flushing of exhaled gas (e.g., carbon dioxide).

[0333] In some configurations, the ventilation port 3400 is configured to allow continuous airflow from the interior of the inflation chamber 3200 to the environment, while the pressure within the inflation chamber is positive relative to the environment. The ventilation port 3400 is configured such that the ventilation flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining the therapeutic pressure within the inflation chamber during use.

[0334] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0335] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a disconnected structure (e.g., a rotating shaft).

[0336] like Figure 7NAs shown, the ventilation port 3450 can be used with the patient interface 3000. The ventilation port 3450 may have a shape substantially similar to that of the ventilation opening 3402-1 (e.g., a generally circular shape).

[0337] The vent 3450 can be connected to the mouth and nose inflation chamber 3200-1 (e.g., Figure 7A (as illustrated) or a pure nasal inflatable chamber 3200-2 (e.g., Figure 7B Used together (as shown in the diagram).

[0338] Continue to refer Figure 7A The vent 3450 may include a vent housing 3404, which may be configured to engage with the vent opening 3402. The vent housing 3404 may be made of a rigid or semi-rigid material. For example, the vent housing 3404 may be made of plastic, metal, or any similar material. The vent housing 3404 may increase the rigidity of the patient interface 3000 (e.g., to limit undesirable bending that could affect the position of the seal-forming structure 3100 on the patient's face).

[0339] The vent housing 3404 may include a front surface 3408, a rear surface 3412, and a recess 3416. The front surface 3408 faces away from the patient's face during use and can be positioned outside the pressurized volume of the inflation chamber 3200. The rear surface 3412 is positioned opposite the front surface 3408. During use, the rear surface 3412 can face the patient and can be disposed within the pressurized volume of the inflation chamber 3200. The recess 3416 may be formed between the front surface 3408 and the rear surface 3412. A portion of the inflation chamber 3200 may be received within the recess 3416 to hold the vent 3400 in place.

[0340] In some configurations, the diffuser 3448 can be used in conjunction with the vent housing 3404. The diffuser 3448 can help limit the decibel output from any patient interface 3000 (or any other patient interface). Specifically, the diffuser 3448 can help limit the decibel level associated with air output (e.g., exhaled air) from the patient interface 3000, although the diffuser 3448 can limit the decibel level at any point within the patient interface.

[0341] In some forms, the diffuser 3448 can diffuse and thus slow down the exhaust gases exiting the inflation chamber 3200 and through the vent housing 3404. The diffuser 3448 can help avoid jetting and associated discomfort to the patient and / or bed partner (e.g., noise caused by jetting onto pillows, sheets, bedding, etc.).

[0342] In some forms, the diffuser may include a front surface 3456 that faces away from the patient during use. The outer diameter of the front surface 3456 may be smaller than the inner diameter of the vent housing 3404 adjacent to the front surface 3408. This can create a gap 3464 through which air can travel.

[0343] Disconnection structure

[0344] In one form, the patient interface 3000 includes at least one disconnection structure, such as a swivel or a ball socket.

[0345] Connection port

[0346] Connection port 3600 allows connection to air circuit 4170.

[0347] Forehead support

[0348] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0349] Anti-suffocation valve

[0350] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0351] port

[0352] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to a volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In another embodiment, this allows direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0353] Modularity

[0354] As mentioned above, the pads, headgear, and sleeves can be of different types, corresponding to different uses (e.g., mouth breathing, nasal breathing, etc.). Patients or clinicians can choose certain combinations of pads, headgear, and sleeves to optimize the effectiveness of the therapy and / or the comfort of the individual patient. An example of such a modular design is described in PCT / SG2022 / 050777, filed on 28 October 2022, the entire contents of which are incorporated herein by reference.

[0355] In some forms, different types of pads, caps, and sleeves can be used interchangeably to create different combinations of patient interfaces. This can be advantageous from a manufacturing perspective, as fewer parts can be used to create a variety of patient interfaces. Additionally or alternatively, these combinations can allow patients to change the type of patient interface without altering each component.

[0356] Air can be delivered to the patient in one of two main ways. In one instance, the patient can be delivered through a head cannula 3350 (see example...). Figure 3Z This receives a pressurized airflow. This can be referred to as an "upper tube" configuration, and the connection port can be positioned at the top of the patient's head. In other instances, the patient can be connected via a catheter to the inflation chamber 3200 (e.g., via connection port 3600 (see example)). Figure 3A This receives a pressurized airflow. This can be referred to as a "lower tube" configuration, where the airflow duct is positioned in front of the patient's face. Different patients may be more comfortable with one type of air delivery (compared to other types) (e.g., due to the patient's sleeping posture). Therefore, it may be beneficial to allow the use of a single type of patient interface in either an "upper tube" or "lower tube" configuration.

[0357] The patient interface can be part of a modular component with various interchangeable parts, which patients and / or clinicians can replace for different types of one or more parts. The following describes the various combinations that can be achieved by assembling the different parts together.

[0358] The modular design is described in more detail below and in PCT application No. PCT / SG2022 / 050777, the entire contents of which are incorporated herein by reference.

[0359] sleeve

[0360] In some configurations, to allow for modularity, the sleeve can be used with tube 3350 and / or hardener arm 3340. The sleeve can at least partially surround tube 3350 and / or hardener arm 3340. For example... Figures 7G to 7I As shown, sleeves of different shapes can be used, corresponding to different types of positioning and stabilization structures 3300. In some forms, the sleeve can be configured to fit the face of a particular user. For example, the sleeve can be configured in a relatively posterior region of the patient's head.

[0361] In some forms, the sleeve can be made of comfort materials. For example, the sleeve can be made of textile materials, foam materials, or a combination of both. Comfort materials can come into contact with the patient during use and feel soft when against the patient's skin, thereby improving patient compliance.

[0362] The material can also be flexible to facilitate the donning or removal of the sleeve from the tube 3350 or the hardener arm 3340. For example, the material may allow the sleeve to bend to conform to the shape of the tube or catheter head cap 3350 or the hardener arm 3340, which can be adapted to the shape of an individual patient's head.

[0363] In some forms, the sleeve may also be at least partially elastic (e.g., the material may allow the sleeve to stretch). The elastic material can help the sleeve stretch to fit around the tube 3350 or hardener arm 3340. The elastic material can then return to its initial position, which rests against the tube 3350 or hardener arm 3340, to limit sleeve slippage during use.

[0364] As described in more detail below, some forms of sleeves can be specifically designed for hardening elements (e.g., tube 3350 and / or hardener arm 3340). However, sleeves can facilitate interchangeable connection of hardening elements with gasket styles or types (e.g., mouth and nose gasket 3050-1, pure nose gasket 3050-2, etc.).

[0365] catheter sleeve

[0366] like Figure 7G As shown, one example of a sleeve is a catheter sleeve 3351, which can be used with the aforementioned tube 3350.

[0367] like Figure 7G As shown, the catheter sleeve 3351 may include similar components. Figure 7C The tube 3350 shown is in a curved shape. The flexible material used to construct the catheter sleeve 3351 allows the catheter sleeve 3351 to be further bent to correspond to the shape of the tube 3350 (e.g., when worn by a patient).

[0368] In some forms, the catheter sleeve 3351 may include a first opening or an upper opening 3352. The upper opening 3352 may be located at one end of the catheter sleeve 3351. The upper opening 3352 may be an opening of a channel extending along at least a portion of the catheter sleeve 3351.

[0369] like Figure 7G As shown, some forms of the catheter sleeve 3351 may also include a lower extension 3354. The lower extension 3354 may be positioned on the end of the catheter sleeve 3351 opposite to the upper opening 3352. The catheter sleeve 3351 may be customized to fit the face of a particular user. For example, the lower extension 3354 of the catheter sleeve 3351 may be configured in a relatively posterior or relatively anterior region of the patient's head.

[0370] Some forms of the lower extension 3354 may include a rigid or semi-rigid member (e.g., within the sleeve 3351). The rigid or semi-rigid member may be made of a plastic material or a similar material. Alternatively, the lower extension 3354 may be reinforced using manufacturing processes (e.g., stitching hardened threads, plain knitting, using a thicker material).

[0371] like Figure 7GAs shown, some forms of the lower extension 3354 may include a connecting member 3356. In the illustrated example, the connecting member 3356 may be a magnet, although in other examples, the connecting member 3356 may be different types of connectors (e.g., mechanical fasteners, adhesives, hook and ring materials, etc.). The connecting member 3356 may also be positioned at one end of the lower extension 3354, although the connecting member 3356 may also be positioned anywhere along the lower extension 3354.

[0372] In some forms, the connecting member 3356 (e.g., a magnet) can be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the conduit sleeve 3351 is connected to the tube 3350 (see, for example, see...) Figure 7J When connected to the lower band 3304-1, the magnet 3370-1 can be removably connected to the connecting member 3356 to provide tension.

[0373] Four-point arm sleeve

[0374] like Figure 7H As shown, another example of the sleeve is the four-point arm sleeve 3380, which can be used in conjunction with the hardener arm 3340 described above.

[0375] like Figure 7H As shown, the four-point arm sleeve 3380 may include similar components. Figure 7D The curvature arm 3340 shown is in a curved shape. The flexible material used to construct the four-point arm sleeve 3380 allows the four-point arm sleeve 3380 to be further bent to correspond to the shape of the curvature arm 3340 (e.g., when worn by a patient and / or bent by a patient).

[0376] like Figure 7H As shown, some forms of the four-point arm sleeve 3380 may include a lower extension 3384. The lower extension 3384 may be positioned at one end of the four-point arm sleeve 3380.

[0377] In the illustrated example, the shape and / or structure of the lower extension 3384 is substantially the same as that of the lower extension 3354. For example, the lower extension 3384 may be more rigid than the rest of the four-point arm sleeve 3380 (e.g., due to hardening of the wire or rigid material).

[0378] like Figure 7HAs shown, some forms of the lower extension 3384 may include a connecting member 3386. In the illustrated example, the connecting member 3386 may be a magnet, although in other examples, the connecting member 3386 may be different types of connectors (e.g., mechanical fasteners, adhesives, hook and ring materials, etc.). The connecting member 3386 may also be positioned at one end of the lower extension 3384, although the connecting member 3386 may also be positioned anywhere along the lower extension 3384.

[0379] In some forms, the connecting member 3386 (e.g., a magnet) can be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the four-point arm sleeve 3380 is connected to the hardener arm 3340 (see, for example...) Figure 7K When connected to the lower band 3304-1, the magnet 3370-1 can be removably connected to the connecting member 3386 to provide tension.

[0380] like Figure 7H As shown, the four-point arm sleeve 3380 may include a pair of tabs 3394, which may be similar to the tabs 3320 on the tube 3350. When the four-point arm sleeve 3380 is worn by a patient, the tabs 3394 may be positioned on the patient's head in substantially the same location as the tabs 3320 are positioned when the patient wears the tube 3350.

[0381] Two-point arm sleeve

[0382] like Figure 7I As shown, another example of a sleeve is the two-point arm sleeve 3380-1, which can be used with the aforementioned hardener arm 3340.

[0383] In some forms, the two-point arm sleeve 3380-1 can be similar to the four-point arm sleeve 3380 described above. Only some similarities and differences are described below.

[0384] like Figure 7I As shown, the two-point arm sleeve 3380-1 may include a lower opening 3388-1 located at one end of the two-point arm sleeve 3380-1. The lower opening 3388-1 may form an opening for a channel through the two-point arm sleeve 3380-1. In the illustrated example, the lower opening 3388-1 may lead to the surface of the conduit sleeve 3380-1.

[0385] like Figure 7IAs shown, the two-point arm sleeve 3380-1 may include a pair of tabs 3394-1, which may resemble the tabs 3320 on the tube 3350. When the two-point arm sleeve 3380-1 is worn by a patient, the tabs 3394-1 may be positioned on the patient's head in substantially the same location as the tabs 3320 are positioned when the patient wears the tube 3350.

[0386] Assembled patient interface

[0387] like Figures 7J to 7M As illustrated, the various components described above can be combined to form four different patient interfaces. Different patient interfaces allow patients to use different types based on their individual comfort levels. The modularity of the different components (e.g., the ability to use multiple types of patient interfaces) simplifies manufacturing and / or allows patients to switch more easily between multiple types of patient interfaces.

[0388] upper tube configuration of nose and mouth mask

[0389] like Figure 7J As illustrated, a patient can wear a pad 3050-1 with a tube 3350 and a four-point head covering 3302-1 in an upper tube configuration. This assembly can form the upper tube's nose and mouth patient interface 3000-1.

[0390] In some configurations, the catheter sleeve can be used with the tube 3350 to allow the patient to experience an "upper tube" air delivery method with the mouth and nose pads 3050-1. As described below, the catheter sleeve provides additional connection points for attaching the four-point headgear 3302-1. However, other types of connectors, besides the catheter sleeve or as an add-on to it, can be used.

[0391] In the illustrated example, the conduit sleeve can be connected to the tube 3350 of the positioning and stabilizing structure 3300. The tube 3350 (via the conduit connection structure 3500) can be used to connect the tube 3350 to the gasket 3050-1. The conduit sleeve provides a magnet for connection to the magnet 3370-1 of the four-point sleeve 3302-1 (see example). Figure 7E Alternatively, different connection methods can be used.

[0392] like Figure 7J As illustrated, the four-point headgear 3302-1 can be connected at four separate locations to provide tension for maintaining the padding 3050-1 in a sealed position on the patient's head.

[0393] For example, the lower band 3304-1 (e.g., via magnetic member 3306-1) can be removably attached to a magnet on the catheter sleeve. In use, each lower band 3304-1 can contact the patient's cheek (e.g., cover the masseter muscle). The lower band 3304-1 can also extend below the patient's ear.

[0394] Nose and mouth mask lower tube configuration

[0395] like Figure 7K As illustrated, the patient can wear a pad 3050-1 with a hardener arm 3340 and a four-point headgear 3302-1 in the lower tube configuration. This assembly can form the lower tube's nasal and mouth patient interfaces 3000-2.

[0396] In some configurations, the catheter sleeve can be used in conjunction with the sclerosing arm 3340 to allow the patient to experience a “lower tube” air delivery method with the mouth and nasal pad 3050-1. As described below, the catheter sleeve provides additional connection points for attaching the four-point headgear 3302-1. However, other types of connectors besides the catheter sleeve or as an add-on to the catheter sleeve can be used.

[0397] In the illustrated example, the conduit sleeve can be connected to the hardener arm 3340 of the positioning and stabilizing structure 3300. The hardener arm 3340 (via conduit connection structure 3504) can be used to connect the hardener arm 3340 to the gasket 3050-1. The conduit sleeve provides a magnet for connection to the magnet 3370-1 of the four-point head sleeve 3302-1 (see example). Figure 7E Alternatively, different connection methods can be used.

[0398] like Figure 7K As illustrated, the four-point headgear 3302-1 can be connected at four separate locations to provide tension for maintaining the padding 3050-1 in a sealed position on the patient's head.

[0399] For example, the lower band 3304-1 (e.g., via magnetic member 3306-1) can be removably attached to a magnet on the catheter sleeve. In use, each lower band 3304-1 can contact the patient's cheek (e.g., cover the masseter muscle). The lower band 3304-1 can also extend below the patient's ear.

[0400] Nose mask upper tube configuration

[0401] like Figure 7L As illustrated, the patient can wear a pad 3050-2 with a tube 3350 and a two-point head cover 3302-2 in an upper tube configuration. This assembly can form an upper tube, nasal patient interface 3000-3 only.

[0402] The catheter sleeve can be used with the tubing 3350 and can provide additional comfort to the patient. The sleeve can be connected to the positioning and stabilizing structure 3300 on the liner 3050-2 without adding an additional connection point. In the illustrated example, the tubing 3350 of the positioning and stabilizing structure 3300 can be directly connected to the liner 3050-2.

[0403] like Figure 7L As shown, the two-point headgear 3302-2 can be connected to the tab 3320 on the tube 3350 to provide tension for maintaining the pad 3050-2 in a sealed position on the patient's head.

[0404] Nasal mask lower tube configuration

[0405] like Figure 7M As illustrated, the patient can wear a pad 3050-2 with a hardener arm 3340 and a two-point headgear 3302-2 in the upper tube configuration. This assembly can form the lower tube nasal-only patient interface 3000-4.

[0406] The catheter sleeve can be used with the sclerosing arm 3340 and can provide additional comfort to the patient. The sleeve can be connected to the positioning and stabilizing structure 3300 on the liner 3050-2 without adding additional connection points. In the illustrated example, the sclerosing arm 3340 of the positioning and stabilizing structure 3300 can be directly connected to the liner 3050-2.

[0407] like Figure 7M As illustrated, the two-point headgear 3302-2 can be connected to the tab 3320 on the sleeve to provide tension for maintaining the pad 3050-2 in a sealed position on the patient's head.

[0408] Modular components

[0409] Figure 7P The diagram illustrates how to combine different components to form the four different patient interfaces described above. As shown, different components can be reused for different types of patient interfaces. This allows for easier manufacturing and assembly because large quantities of the same components can be produced and used in various types. The only component not used in multiple types could be the sleeve. However, the sleeve is easier to manufacture. Figure 7O A portion of the air circuit 4170 that can interface with the patient is shown, while Figure 7N This demonstrates interchangeable replacements based on the type of patient interface. Figure 7O The air vent 3404 of the air circuit shown.

[0410] cushioning material for patient interfaces

[0411] To improve the patient experience when using respiratory pressure therapy devices, the user interface should provide a comfortable experience. In this regard, careful selection of materials or fabrics that come into contact with the patient is necessary.

[0412] Elastomer nonwovens have been found to provide a soft, airtight surface and can be introduced as materials for forming seal-forming structures and / or positioning and stabilizing structures. Elastomer nonwovens can also be used as cushioning materials. Furthermore, they can be incorporated into a variety of materials commonly used in patient interfaces. Additionally, elastomeric nonwovens can be layered onto foam to provide patients with an even better soft touch and comfort during use. Elastomer nonwovens also offer better elastic recovery for patient interfaces, resulting in lower deformation and longer service life.

[0413] In one form of this technology, a patient interface including a cushioning material is provided. The cushioning material comprises a patient-facing elastomeric nonwoven material. This elastomeric nonwoven material is soft and flexible. It is soft because it can bend under pressure. It is flexible because it can bend or flex without breaking. The patient-facing side is the outer surface that can come into contact with the patient's skin during use.

[0414] Elastomer nonwoven materials can be used as is without the need for any additional support provided by adding other, more resilient materials. It has been found that elasomer nonwoven materials can be configured to provide sufficient structural support when used alone. Alternatively, the cushioning material can be a cushioning composite material, also including flexible and / or resilient materials. For further structural support, elasomer nonwoven materials can be combined with flexible and / or resilient materials.

[0415] In one form of this technology, a seal-forming structure is provided. This seal-forming structure includes a seal-forming region formed of a cushioning material comprising a patient-facing elastomeric nonwoven material. The seal-forming region may not contain the elastic material. Alternatively, the seal-forming region may include a cushioning composite comprising an elastomeric nonwoven material and an elastic material. The elastic material is capable of springing back or returning to its original shape after being bent, stretched, or compressed. The elastic material may be a foam. The elastic material may be selected from silicone, polycarbonate, polyethylene, polypropylene, polystyrene, polyurethane, nylon, thermoplastic elastomers, polycarbonate-acrylonitrile butadiene styrene (PC-ABS), polyethylene terephthalate (PET), or combinations thereof. The cushioning material may be configured to be taut to maintain a tight seal with the user's face.

[0416] In one form of this technology, the cushioning material comprises a patient-facing elastomeric nonwoven material bonded to a flexible and / or elastic material. The flexible and / or elastic material may be a foam selected from silicone, polycarbonate, polyethylene, polypropylene, polystyrene, polyurethane, or combinations thereof. The elastomeric nonwoven material may be bonded to the flexible and / or elastic material. In particular, the elastomeric nonwoven material may be ultrasonically bonded to the flexible and / or elastic material. In one form of this technology, the seal-forming structure further includes one or more of a sealing flange, a support flange, a compression-sealing portion, and a tension portion, wherein at least one of the sealing flange, support flange, compression-sealing portion, and tension portion is formed of the cushioning material. In one form of this technology, the seal-forming structure is entirely formed of the cushioning material.

[0417] In one form of this technology, a positioning and stabilizing structure is provided. This positioning and stabilizing structure may include a cushioning material, wherein the cushioning material comprises an elastomeric nonwoven material. The elastomeric nonwoven material may be patient-facing. The elastomeric nonwoven material may be incorporated into a flexible and / or elastic material. The flexible and / or elastic material may be a fabric material or a composite material. The flexible and / or elastic material may be sandwiched between elastomeric nonwoven materials on its two sides. Alternatively, the elastomeric nonwoven material may be sandwiched between flexible and / or elastic materials on its two sides. The positioning and stabilizing structure may be as follows: Figure 7C The catheter tip shown. In this case, cushioning material may wrap around one or more tip tubes, or cushioning material may be present at least on the patient-facing side of one or more tip tubes.

[0418] Elastomer nonwovens are elastomeric materials formed into a woven fabric. This elastomer is a polymer exhibiting rubber-like elasticity. It possesses viscosity and elastic properties, weak intermolecular forces, and a low Young's modulus. Nonwoven fabrics are woven materials made of short and long fibers, bound together by chemical, mechanical, or solvent treatments to entangle the fibers. Nonwoven fabrics are neither woven nor knitted.

[0419] Elastomer polymers consist of hard segments and soft segments. Hard segments provide strength and stiffness, while soft segments provide elasticity but can produce a sticky feel in fabrics. A balance between hard and soft segments is needed to maximize the desired properties of both.

[0420] In one form of this technology, the elastomeric nonwoven fabric is made of a nonwoven fabric. Nonwoven fabrics are often desirable due to their fibrous structure and high total surface area. The nonwoven fabric can be a stapled nonwoven fabric, a spunlace nonwoven fabric, a spunbond nonwoven fabric, a flash-spun nonwoven fabric, an air-laid nonwoven fabric, or a meltblown nonwoven fabric. The nonwoven fabric can be made of polypropylene, polyester, viscose fiber, and / or cotton.

[0421] Elastomer nonwovens can be meltblown. Meltblown nonwovens are produced by extruding molten polymer fibers through a spinning web or die consisting of up to 40 holes per inch to form long, fine fibers. As the fibers fall from the die, they are stretched and cooled by passing hot air over them. The resulting web is collected and woven into a fabric-like material. Fibers used in the meltblowing process can be made extremely fine. Meltblown fibers can also be combined with other types of elastomeric nonwovens, such as staple fibers, spunbond, and / or flash-spun fibers, to form fabric-like materials with different properties.

[0422] In one embodiment of this technology, the elastomeric nonwoven layer is formed of a thermoplastic elastomer. In another embodiment of this technology, the elastomeric nonwoven layer is selected from polyolefin-based elastomers, copolyester elastomers, thermoplastic polyurethane elastomers, styrene block copolymers, or combinations thereof. The elastomeric nonwoven layer may have a hard segment:soft segment ratio of 1:0.1 to approximately 1:10.

[0423] In one form of this technology, the elastomeric nonwoven fabric is selected from polyether block amide (Pebax), thermoplastic elastomer ether ester (Hytrel), thermoplastic polyurethane (Elastolan), styrene-rubber block copolymer (Kraton), or combinations thereof. For example, Pebax includes nylon 11 as a hard segment, while Hytrel includes polybutylene terephthalate as a hard segment.

[0424] In one form of the present invention, the elastomeric nonwoven fabric is characterized by a thickness of about 0.3 mm to about 2 mm. In another form of the present invention, the elastomeric nonwoven fabric is characterized by a thickness of about 0.5 mm to about 1.5 mm.

[0425] In one form of this technology, the elastomeric nonwoven fabric is characterized by a fiber diameter of about 1 μm to about 50 μm.

[0426] In one form of this technology, the elastomeric nonwoven fabric is characterized by a fiber denier of about 1 to about 20.

[0427] In one form of this technology, the elastomeric nonwoven fabric is characterized by fiber lengths of about 1 cm to about 10 cm.

[0428] In one form of this technology, the elastomer nonwoven fabric is characterized by a total fiber surface area of ​​approximately 10 m². 2 Approximately 60m 2 .

[0429] In one form of this technology, the elastomer nonwoven fabric is characterized by an areal density of about 0.5 g / cm³. 3 Approximately 2g / cm 3 .

[0430] In one form of the present technology, the elastomeric nonwoven fabric is characterized by interfiber spacing of about 0.1 μm to about 10 μm, about 1 μm to about 10 μm, about 5 μm to about 10 μm, about 0.1 μm to about 8 μm, about 0.1 μm to about 5 μm, about 0.5 μm to about 8 μm, or about 0.5 μm to about 5 μm.

[0431] In one form of the present technology, the elastomeric nonwoven fabric is characterized by a pore size or mesh size of about 0.1 μm to about 10 μm, about 1 μm to about 10 μm, about 5 μm to about 10 μm, about 0.1 μm to about 8 μm, about 0.1 μm to about 5 μm, about 0.5 μm to about 8 μm, or about 0.5 μm to about 5 μm.

[0432] In one form of the present technology, the elastomeric nonwoven fabric is characterized by a porosity of about 50% to about 90%, about 50% to about 80%, about 60% to about 90%, or about 65% to about 85%.

[0433] Pilling is a surface defect that occurs when fibers migrate from a fabric and form tangled fiber balls or beads, which are anchored to the fabric surface by protruding fibers. The tendency of a fabric to pill is influenced by many factors, such as the type of fiber or blend, fiber size, fiber structure, and fabric finishing treatments. Pilling can impair the user's acceptability of the textile. Pilling resistance can be graded on a scale of 1 (very severe pilling) to 5 (no pilling). This can be assessed using ISO 12945-1 / 2. In one form of this technology, the elastomeric nonwoven fabric is characterized by a pilling resistance of at least grade 3. In another form of this technology, the elastomeric nonwoven fabric is characterized by a pilling resistance of at least grade 4.

[0434] Snagging is a defect caused by fibers being pulled or stretched from the fabric surface. Snagging degrades the appearance and durability of the fabric. Factors affecting snagging include fabric tightness, tear strength, fiber elongation and elasticity, and fabric thickness. Snagging resistance can be graded on a scale from 1 (very severe snagging) to 5 (no snagging). This can be evaluated using ASTM D3939-13. In one form of this technology, the elastomeric nonwoven fabric is characterized by a snagging resistance of at least 4. In another form of this technology, the elastomeric nonwoven fabric is characterized by a snagging resistance of at least 5.

[0435] In one form of this technology, the elastomeric nonwoven fabric is characterized by a shrinkage rate of less than 10%. In another form of this technology, the elastomeric nonwoven fabric is characterized by a shrinkage rate of less than 5%. This can be evaluated using ISO 5077-2007 and AATCC 135.

[0436] In one form of this technology, the elastomeric nonwoven fabric is characterized by a tear resistance of about 1N to about 10N, about 2N to about 10N, about 3N to about 10N, about 4N to about 10N, about 5N to about 10N, about 6N to about 10N, about 7N to about 10N, or about 8N to about 10N. Tear resistance is a measure of the extent to which a material can withstand tearing. Tear resistance can be measured using the tongue / single tear ASTM D2261 method.

[0437] In one form of this technology, the elastomeric nonwoven fabric is characterized by a tensile strength of about 10 N to about 50 N, about 12 N to about 50 N, 14 N to about 50 N, 16 N to about 50 N, 18 N to about 50 N, 20 N to about 50 N, 22 N to about 50 N, 24 N to about 50 N, 26 N to about 50 N, 28 N to about 50 N, or 30 N to about 50 N. The tensile properties of the elastomeric nonwoven fabric can be measured using ASTM D5035 strips. The elastomeric nonwoven fabric can also be highly flexible, with no wrinkles in the bending region.

[0438] In one form of this technology, the elastomeric nonwoven fabric is calendered. Fabric calendering is a finishing process used to smooth, coat, or thin materials. The fabric passes between rollers under high temperature and pressure. This process flattens the rounded fibers on the surface and reduces the inter-fiber distance and the fabric's pore size. This polishes the fabric surface and makes the fabric smoother and shinier.

[0439] In one form of this technology, an elastomeric nonwoven fabric is bonded to a flexible and / or elastic material. The flexible and / or elastic material may be a foam. The flexible and / or elastic material may be selected from silicone, polycarbonate, polyethylene, polypropylene, polystyrene, polyurethane, nylon, thermoplastic elastomers, polycarbonate-acrylonitrile butadiene styrene (PC-ABS), polyethylene terephthalate (PET), or combinations thereof. Bond strength can be measured using ASTM S1876-08. In one form of this technology, the elastomeric nonwoven fabric is ultrasonically bonded to the flexible material. Alternatively, the elastomeric nonwoven fabric may be bonded to the flexible material via adhesives, lamination, heat sealing, mechanical bonding, chemical bonding, and / or welding.

[0440] In one form of this technology, the elastomer nonwoven fabric is biocompatible.

[0441] When an elastomeric nonwoven fabric is formed as a cushioning material in a sealing or positioning and stabilizing structure, the elastomeric nonwoven fabric can form a surface facing the patient. In this way, the patient can directly feel the softness and airtightness of the fabric.

[0442] Alternatively, cushioning materials can be used as components for positioning and stabilizing the structure. For example, elastomeric nonwoven fabrics can be used as layers forming the cushioning material. Figure 6A An example of a cushioning composite material 6000 is shown, wherein an elastomeric nonwoven fabric 6020 is sandwiched as a layer between two flexible materials 6010. The elastomeric nonwoven fabric 6020 may be incorporated into one flexible material 6010 or into two flexible materials 6010. This can provide greater elastic recovery for positioning and stabilizing the structure and can achieve flat force. Although not shown, embodiments in which flexible materials are sandwiched between two layers of elastomeric nonwoven fabric are also possible.

[0443] In one form of this technology, the positioning and stabilizing structure includes a cushioning material comprising an elastomeric nonwoven material sandwiched between two flexible and / or elastic materials on either side. The flexible and / or elastic materials can be woven fabrics or composite materials. The elastomeric nonwoven material can be incorporated into at least one of the flexible and / or elastic materials. The cushioning material can be formed as a sleeve for use with a hardener and / or conduit.

[0444] RPT device

[0445] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to perform one or more algorithms 4300, such as any methods, in whole or in part, described herein. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0446] In one embodiment, the RPT device 4000 is configured and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0447] The RPT device may have an outer housing 4010, which is formed in two parts: an upper portion 4012 and a lower portion 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0448] The pneumatic path of the RPT device 4000 may include one or more air path objects, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying positive pressure air, an outlet silencer 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0449] One or more of the air path objects may be located within a removable integral structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be located within an outer housing 4010. In one form, pneumatic block 4020 is supported by or formed as part of chassis 4016.

[0450] Mechanical and pneumatic components of the RPT device

[0451] The RPT device may include one or more of the following components in an overall unit. In an alternative form, one or more of the following components may be positioned as respective individual units.

[0452] air filter

[0453] One form of RPT device according to the present technology may include an air filter 4110 or a plurality of air filters 4110.

[0454] exist Figure 4B In one embodiment of the illustration, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0455] exist Figure 4B In one embodiment illustrated, an outlet air filter 4114, such as an antibacterial filter, is located between the outlet of pneumatic block 4020 and patient interface 3000 or 3800.

[0456] silencer

[0457] One form of RPT device according to the present technology may include one or more mufflers 4120.

[0458] In one form of this technology (see, for example, see...) Figure 4B The inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0459] In one embodiment of this technology, the outlet silencer 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800.

[0460] pressure generator

[0461] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. The blower may deliver an air supply at a rate up to about 120 liters per minute, for example, when delivering respiratory pressure therapy, and at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013 / 020167.

[0462] The pressure generator 4140 can be controlled by the therapy device controller 4240.

[0463] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator or bellows connected to a high-pressure source (such as a compressed air reservoir).

[0464] transducer

[0465] The transducer can be inside or outside the RPT device. An external transducer can be located on, for example, an air circuit (e.g., a patient interface) or form part of an air circuit. The external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or sends data to or to the RPT device.

[0466] In one form of this technology (see example) Figure 4B One or more transducers 4270 are located upstream and / or downstream of pressure generator 4140. One or more transducers 4270 may be configured and arranged to generate signals representing characteristics of airflow, such as flow rate, pressure, or temperature at that point in the pneumatic path.

[0467] In one form of this technology, one or more transducers 4270 may be located near the patient interface 3000 or 3800.

[0468] In one embodiment, the signal from transducer 4270 can be filtered, for example, by low-pass filtering, high-pass filtering, or band-pass filtering.

[0469] Anti-overflow valve

[0470] like Figure 4BAs shown, in one form of this technology, an anti-backflow valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., towards the motor 4144).

[0471] RPT device electrical components

[0472] power supply

[0473] The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.

[0474] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of this technology, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.

[0475] Input device

[0476] In one form of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow human interaction with the device. The buttons, switches, or dials can be physical devices or software devices accessible via a touchscreen. In one form, the buttons, switches, or dials can be physically connected to an external housing 4010, or in another form, they can communicate wirelessly with a receiver electrically connected to a central controller 4230.

[0477] In one form, the input device 4220 may be configured and arranged to allow a person to select values ​​and / or menu options.

[0478] air circuit

[0479] According to one aspect of the art, the air circuit 4170 is a conduit or tube that is constructed and arranged to allow airflow to travel between two components (such as the RPT device 4000 and the patient interface 3000 or 3800) during use.

[0480] Specifically, the air circuit 4170 can be fluidly connected to the outlet and patient interface of the pneumatic block 4020. This air circuit may be referred to as an air delivery tube. In some cases, separate branches may be present for the inhalation and exhalation circuits. In other cases, a single branch is used.

[0481] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example, to maintain or raise the temperature of the air. The heating element may be in the form of a heated wire loop and may include one or more transducers, such as temperature sensors. In one form, the heated wire loop may be helically wound around the axis of the air circuit 4170. The heating element may be communicated with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heated wire loop is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0482] humidifier

[0483] Humidifier Overview

[0484] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 5A (As shown), to change the absolute humidity of the air or gas delivered to the patient relative to ambient air. Typically, a humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0485] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering the humidified airflow. In some forms, such as Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which is adapted to accommodate the humidifier reservoir 5110 and includes a heating element 5240.

[0486] Humidifier components

[0487] Water storage tank

[0488] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or retain a volume of liquid to be evaporated (e.g., water) to humidify the airflow. The water reservoir 5110 may be configured to hold a predetermined maximum volume of water to provide adequate humidification at least for the duration of a respiratory therapy session, such as an overnight sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 ml, 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply system.

[0489] According to one aspect, the water reservoir 5110 is configured to increase the humidity of an airflow from the RPT device 4000 as airflow passes through it. In one form, the water reservoir 5110 may be configured to facilitate the airflow's travel in a curved path through the reservoir 5110 while in contact with the water contained therein.

[0490] According to one form, the storage 5110 can, for example, be along such a path. Figure 5A and Figure 5B The lateral direction shown is removed from the humidifier 5000.

[0491] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any orifice and / or between its sub-components, when the reservoir 5110 is displaced and / or rotated from its normal operating direction. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent loss of pneumatic pressure due to leakage and / or flow resistance.

[0492] conductive part

[0493] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume within the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes are equally applicable. All or part of the conductive portion 5120 may be made of a thermally conductive material such as aluminum (e.g., with a thickness of about 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastic. In some cases, suitable thermal conductivity can be achieved using materials with appropriate geometries and lower thermal conductivity.

[0494] Humidifier storage base

[0495] In one embodiment, the humidifier 5000 may include a humidifier reservoir base 5130 (e.g., Figure 5B As shown, the humidifier reservoir base 5130 is configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include locking features, such as a locking lever 5135 configured to retain the reservoir 5110 in the humidifier reservoir base 5130.

[0496] Water level indicator

[0497] The humidifier storage unit 5110 may include, for example: Figures 5A to 5BThe water level indicator 5150 is shown. In some forms, the water level indicator 5150 can provide a user (such as a patient 1000 or a caregiver) with one or more indications about the volume of water in the humidifier reservoir 5110. One or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof (such as 25%, 50%, 75%), or a volume such as 200 ml, 300 ml, or 400 ml.

[0498] pressure transducer

[0499] As an addition to or replacement of the pressure sensor 4272 provided in the RPT device 4000, one or more pressure transducers 5212 may be provided to the humidifier 5000.

[0500] Flow transducer

[0501] As an addition to or replacement of the flow sensor 4274 provided in the RPT device 4000, one or more flow transducers 5214 may be provided to the humidifier 5000.

[0502] Temperature transducer

[0503] The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures, such as the temperature of the heating element 5240 and / or the temperature of the airflow downstream of the humidifier outlet 5004. In some forms, the humidifier 5000 may also include a temperature sensor 5216 for detecting the ambient air temperature.

[0504] Humidity transducer

[0505] In some forms, the humidifier 5000 may include one or more humidity sensors 5218 to detect the humidity of a gas, such as ambient air. In some forms, the humidity sensor 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.

[0506] Heating element

[0507] In some cases, a heating element 5240 may be provided to the humidifier 5000 to provide heat input to one or more volumes of water in the humidifier reservoir 5110 and / or to an airflow. The heating element 5240 may include a heating component, such as a resistance-heated rail. A suitable example of the heating element 5240 is a layered heating element, such as the layered heating element described in PCT patent application publication number WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0508] In some configurations, the heating element 5240 may be housed in the humidifier base 5006, where heat can be supplied primarily to the humidifier reservoir 5110 via conduction, such as... Figure 5B As shown.

[0509] Breathing therapy mode

[0510] Various breathing therapy modalities can be implemented through the publicly available breathing therapy system.

[0511] High-flow therapy

[0512] In other forms of respiratory therapy, the pressure of the airflow is not controlled as in respiratory pressure therapy. Instead, a central controller 4230 controls a pressure generator 4140 to deliver an airflow at a device flow rate Qd controlled as a therapeutic flow rate or target flow rate Qtgt, which is typically positive throughout the patient's respiratory cycle. Such forms are often grouped under the heading of flow therapy. In flow therapy, the therapeutic flow rate Qtgt can be a constant value, either hard-coded or manually entered into the RPT device 4000. If the therapeutic flow rate Qtgt is sufficient to exceed the patient's peak inspiratory flow rate, the therapy is often referred to as high-flow therapy (HFT). Alternatively, the therapeutic flow rate can be a curve Qtgt(t) that varies with the respiratory cycle.

[0513] Glossary

[0514] For the purposes of this disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0515] generally

[0516] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-enriched air.

[0517] Environment: In some forms of this technology, the term environment will be considered to mean (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0518] For example, the environment relative to a humidifier humidity This could be the humidity of the air directly surrounding the humidifier, such as the humidity in the room where the patient sleeps. This type of environmental humidity can differ from the humidity outside the patient's room.

[0519] In another instance, environmental stress can be stress that is either close to or outside the body.

[0520] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the room where the patient is located, rather than noise generated, for example, by the RPT device or emanating from the mask or patient interface. Ambient noise can be generated by sources outside the room.

[0521] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjustable (e.g., varies with each breath) between the minimum and maximum, depending on the presence of an indication of an SDB event.

[0522] Continuous positive airway pressure (CPAP) therapy: a respiratory pressure therapy in which the treatment pressure remains substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles, for example, increasing in response to the detection of signs of partial upper airway obstruction and decreasing when signs of partial upper airway obstruction are not present.

[0523] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be a scalar quantity, i.e., a quantity that only has magnitude. In other cases, the reference to flow rate will be a vector quantity, i.e., a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. "Flow rate" is sometimes simply abbreviated as "flow" or "airflow".

[0524] In the context of patient breathing, flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Device flow rate Qd is the flow rate of air leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. Ventilation flow rate Qv is the flow rate of air leaving the vent to allow flushing of exhaled gas. Leakage flow rate Ql is the leakage flow rate from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received from the patient's respiratory system.

[0525] Flow therapy: Breathing therapy involves delivering a controlled flow of air to the entrance of the airway at a rate known as therapeutic flow, which is typically positive throughout the patient’s respiratory cycle.

[0526] Humidifier: The term humidifier will be considered to mean a humidifying device that is constructed and arranged or configured to have a physical structure that enables it to deliver a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve a patient’s medical respiratory condition.

[0527] Leakage: The term leakage is considered to refer to unintended airflow. In one instance, leakage might occur due to an incomplete seal between the mask and the patient's face. In another instance, leakage might occur in a swivel bend leading to the environment.

[0528] Conducted noise (acoustic): In this document, conducted noise refers to noise transmitted to the patient through pneumatic paths, such as air circuits and patient interfaces, and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0529] Radiated noise (acoustics): In this document, radiated noise refers to noise transmitted to the patient by ambient air. In one form, radiated noise can be quantified according to ISO 3744 by measuring the sound power / sound pressure level of the object in question.

[0530] Ventilation noise (acoustic): Ventilation noise in this document refers to the noise generated by the flow of air through any ventilation opening (such as the ventilation port of the patient interface).

[0531] Oxygen-enriched air: Air with an oxygen concentration greater than that of atmospheric air (21%), for example, at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. “Oxygen-enriched air” is sometimes simply referred to as “oxygen”.

[0532] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0533] Patient: A person, regardless of whether they have a respiratory illness.

[0534] Pressure: Force per unit area. Pressure can be expressed in units of area, including cmH2O and gf / cm². 2 1000 Pascals. 1 cmH2O equals 1 g-f / cm³ 2 And it is approximately 0.98 hPa (1 hPa = 100 Pa = 100 N / m). 2= 1 millibar to 0.001 atmospheres. In this specification, unless otherwise stated, pressure is given in cmH2O.

[0535] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained through the interface pressure Pm at the current moment.

[0536] Respiratory pressure therapy: Applying an air supply to the airway entrance at a therapeutic pressure that is normally positive relative to the atmosphere.

[0537] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0538] Materials and their properties

[0539] Hardness: refers to the hardness of a hardness tester or indentation hardness, which is a material property measured by indentation through an indenter (e.g., as measured according to ASTM D2240).

[0540] "Soft" materials can include silicone resins or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0541] "Hard" materials can include polycarbonate, polypropylene, and are not easily deformed, for example, under finger pressure.

[0542] Silicone resin or silicone elastomer: synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or compression-molded silicone rubber (CMSR). One commercially available form of LSR is SILASTIC, manufactured by Dow Corning (included in the product range sold under this trademark). Another manufacturer of LSR is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45, as measured using ASTM D2240.

[0543] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0544] Mechanics

[0545] axis:

[0546] Neutral axis: The axis in the cross-section of a beam or slab where there is no longitudinal stress or strain.

[0547] Longitudinal axis: An axis that extends along the length of the shape. This axis typically passes through the center of the shape.

[0548] Circumferential axis: An axis oriented perpendicularly to the longitudinal axis. This axis can specifically exist in pipes, tubes, cylinders, or similar shapes with circular and / or elliptical cross-sections.

[0549] Deformation: The process by which the original geometry of a component changes when subjected to a force (e.g., a force in a direction relative to an axis). This can include stretching or compression, bending, and twisting.

[0550] Elasticity: The ability of a material to return to its original geometry after deformation.

[0551] Flexible structures or components: structures or components that will change shape (e.g., bend) when subjected to a relatively short period of time, such as 1 second, to support their own weight.

[0552] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0553] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain silicone resins and thermoplastic elastomers.

[0554] Rigid structures or components: Structures or components that do not substantially change shape when subjected to loads typically encountered in use. An example of this use is, for instance, establishing and maintaining a seal between the patient interface and the inlet of the patient's airway under a load of approximately 20 to 30 cmH2O.

[0555] For example, an I-beam can have a different bending stiffness (resistance to bending loads) along the first direction compared to the second orthogonal direction. In another instance, a structure or component can be flexible along the first direction and rigid along the second direction.

[0556] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. This load can be a force or moment, such as compression, tension, bending, or torsion. The structure or component can provide different resistance in different directions. The reciprocal of stiffness is flexibility.

[0557] Viscosity: The ability of a material to resist flow.

[0558] Viscoelasticity: The ability of a material to exhibit both elastic and viscous behavior during deformation.

[0559] Yield: The condition where a material, after being deformed, no longer returns to its original geometry.

[0560] Structural components

[0561] Compression component: A structural element that resists compressive forces.

[0562] A bend: A bend is an example of a structure that guides airflow across its axis of travel by changing direction at an angle. In one form, this angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. A bend can have an approximately circular cross-section. In another form, a bend can have an oval or rectangular cross-section. In some forms, the bend can rotate relative to the mating component, for example, approximately 360 degrees. In some forms, the bend can be removed from the mating component, for example, via a snap-fit ​​connection. In some forms, the bend can be assembled to the mating component during manufacturing via a disposable snap-fit, but cannot be removed by the patient.

[0563] Frame: The frame is generally considered to refer to the mask structure that bears the tensile load between two or more connection points to the hood. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0564] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0565] Lacing (noun): A structure designed to resist tension.

[0566] Thin structure:

[0567] Liang,

[0568] i. Compared to the other two dimensions, the beam can be relatively long in one dimension, making the smaller dimension relatively thinner compared to the longer dimension.

[0569] membrane,

[0570] i. Relatively long in two dimensions and relatively thin in one dimension. Easily deforms in response to bending forces. Resistant to stretching (and possibly compression).

[0571] Plates and shells

[0572] i. They can be relatively long in two directions and relatively thin in one dimension. They can have bending, tensile, and / or compressive stiffness.

[0573] Thick structure: solid

[0574] Sealing: can be the noun form referring to a structure ("seal") or the verb form referring to an effect ("seal"). Two elements can be constructed and / or arranged to "seal" or to achieve "seal" between them without the need for a separate "seal" element itself.

[0575] Shell: A shell is generally considered to refer to a curved, relatively thin structure with bending, tensile, and compressive stiffness. For example, the curved structural walls of a face mask can be 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.

[0576] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0577] Column: A column will be considered a structural component designed to increase the compressive strength of another component in at least one direction.

[0578] Rotary shaft (noun): A sub-assembly of a component configured to rotate, preferably independently, about a common axis, preferably under low torque. In one form, the rotary shaft may be configured to rotate at least 360 degrees. In another form, the rotary shaft may be configured to rotate less than 360 degrees. When used in the case of air delivery conduits, the sub-assembly of the component preferably comprises a pair of mating cylindrical conduits. In use, little or no airflow leaks from the rotary shaft.

[0579] respiratory cycle

[0580] Apnea: According to some definitions, apnea is considered to occur when airflow drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction in the airway prevents airflow despite the patient's efforts. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0581] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0582] Duty cycle: The ratio of inhalation time Ti to total breathing time Ttotal.

[0583] Effort (breathing): The work that a person who breathes spontaneously tries to do while breathing.

[0584] The expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0585] Flow restriction: Flow restriction is considered a state of breathing in which increased effort by the patient does not result in a corresponding increase in flow. Flow restriction occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow restriction. Flow restriction occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow restriction.

[0586] Types of flow-limited inhalation waveforms:

[0587] (i) Flattening: First rises, then a relatively flat section, then falls.

[0588] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.

[0589] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.

[0590] (iv) Inverted chair shape: has a relatively flat section followed by a single local peak located at the trailing edge.

[0591] Insufficient breathing: By some definitions, insufficient breathing is considered a reduction in flow, not a cessation of flow. In one form, insufficient breathing can be considered to have occurred when the flow rate decreases below a threshold rate for a sustained period of time. Central insufficient breathing is considered to have occurred when insufficient breathing is detected due to reduced respiratory effort. In one form for adults, any of the following can be considered insufficient breathing:

[0592] (i) The patient's breathing decreases by 30% for at least 10 seconds, plus an associated 4% desaturation; or

[0593] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% associated desaturation or arousal.

[0594] Hyperventilation: Increased airflow to above normal levels.

[0595] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0596] Patentity (airway): The degree to which the airway is open or the extent to which the airway is open. A patent airway is open. Airway patentness can be quantified, for example, a value (1) for patent and a value of zero (0) for closed (obstructed).

[0597] Positive end-expiratory pressure (PEEP): The pressure above atmospheric pressure present in the lungs at the end of expiration.

[0598] Peak flow (Q peak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0599] Respiratory flow rate, patient airflow rate, and respiratory airflow rate (Qr): These terms can be understood as the RPT device's estimate of respiratory flow rate, as opposed to "true respiratory flow rate" or "real respiratory flow," which is the actual respiratory flow rate experienced by the patient, usually expressed in liters per minute.

[0600] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, the inspiratory volume Vi (volume of air inhaled) equals the expiratory volume Ve (volume of air exhaled), and therefore a single tidal volume Vt can be defined as equal to either volume. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, such as an average.

[0601] Inhalation time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0602] Exhalation time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0603] Total time (Ttotal): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0604] Typical recent ventilation: The recent values ​​of ventilation (Vent) tend to converge at a predetermined time scale, which is a measure of the central tendency of recent ventilation values.

[0605] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or even decreases as the pressure differential across the upper airway increases (Starling resistor behavior).

[0606] Ventilation: A measurement of the rate at which gases are exchanged by a patient's respiratory system. A ventilation measurement may include one or both of inspiratory flow rate and expiratory flow rate (per unit time). When expressed as volume per minute, this amount is often referred to as "minute ventilation."

[0607] anatomy

[0608] Facial Anatomy

[0609] Alar: The outer wall or "wing" of each nostril (plural: alar)

[0610] Alar angle: The angle formed between the alae of each nostril.

[0611] Alar tip: the outermost point on the ala of the nose.

[0612] Alar curvature (or alar ridge) point: the last point in the curvature baseline of each alar, found in the crease formed by the connection between the alar and the cheek.

[0613] Auricle: The entire visible external part of the ear.

[0614] (Nasal) Bone framework: The bony framework of the nose includes the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0615] (Nasal) Cartilaginous Framework: The cartilaginous framework of the nose includes the septal cartilage, lateral cartilage, major cartilage, and minor cartilage.

[0616] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0617] Columellar angle: The angle between a line drawn through the midpoint of the nasal cavity and a line drawn perpendicular to the Frankfurt horizontal plane that intersects the lower point of the nasal septum.

[0618] Frankfurt plane: A line extending from the lowest point of the orbital rim to the left tragus point. The tragus point is the deepest point in the notch above the tragus of the auricle.

[0619] The glabella is the most prominent point in the midsagittal plane of the forehead, located on the soft tissue.

[0620] Lateral nasal cartilage: a roughly triangular cartilaginous plate. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0621] Lower lip (lower lip margin point): The lip extending between the lower nasal septum and the mouth.

[0622] Upper lip (upper lip border point): The lip that extends between the mouth and the mentagrophytes.

[0623] Greater alar cartilage: A cartilaginous plate located beneath the lateral nasal cartilage. It curves around the front of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four small cartilages of the alar.

[0624] Nostrils (Nares / Nostrils): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils (nares) is nasal nasal (naris) (nostril). Nostrils are separated from the nasal septum.

[0625] Nasolabial folds or nasolabial grooves: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lips.

[0626] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0627] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0628] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0629] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0630] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0631] Prechin point: Located on the soft tissue, at the very front midpoint of the chin.

[0632] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0633] Sagittal plane: A vertical plane running from the front (anterior part) to the back (posterior part). The median sagittal plane is the sagittal plane that divides the body into left and right halves.

[0634] The bridge of the nose point is located on the soft tissue and is the most concave point in the area covering the nasolabial fold.

[0635] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0636] Lower edge of the nasal ala: The point at the lower edge of the base of the nasal ala, where the base of the nasal ala connects with the skin of the upper (upper) lip.

[0637] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0638] Supramental point: The point with the greatest concavity located on the midline of the lower lip, between the midpoint of the lower lip and the premental point of the soft tissue.

[0639] Skull Anatomy

[0640] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0641] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0642] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw and below the orbit. The frontal process of the maxilla protrudes upward from one side of the nose and forms part of the lateral border.

[0643] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary among individuals; they are placed side by side in the middle and upper part of the face and form the "bridge" of the nose through their intersection.

[0644] Nasal root: The indentation between the frontal bone and the two nasal bones, located directly between the eyes and above the bridge of the nose.

[0645] Occipital bone: The occipital bone is located in the dorsal and lower parts of the skull. It includes the foramen magnum (oval foramen), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0646] The eye socket is the bony cavity in the skull that houses the eyeball.

[0647] Parietal bone: The parietal bone is the skeleton that forms the top and sides of the skull when they are joined together.

[0648] 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.

[0649] Cheekbones: The face consists of two cheekbones, located on the upper and outer parts of the face and forming the protruding part of the cheek.

[0650] Respiratory system anatomy

[0651] Diaphragm: A muscular sheet that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0652] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0653] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0654] 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 either side of the nasal cavity are three horizontal branches called nasal conchae (singular "concha") or nasal bones. The anterior part of the nasal cavity is the nasal part, while the posterior part connects to the nasopharynx through the posterior nasal aperture.

[0655] Pharynx: The part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three segments: the nasopharynx (hyperpharynx), the oropharynx (middle pharynx), and the laryngopharynx (hypopharynx).

[0656] Patient Interface

[0657] Anti-asphyxiation valve (AAV): A component or sub-assembly of a mask system that reduces the risk of a patient rebreathing excessive CO2 by opening to the atmosphere in a safe manner.

[0658] Headgear: Headgear will be considered to refer to a form of positioning and stabilizing structure designed to hold devices (such as masks) on the head.

[0659] Inflation chamber: The mask inflation chamber is considered to refer to a portion of the patient interface having a wall that at least partially surrounds a volume containing air pressurized to above atmospheric pressure during use. A shell may form part of the wall of the mask inflation chamber.

[0660] Sealing: can be the noun form referring to a structure ("seal") or the verb form referring to an effect ("seal"). Two elements can be constructed and / or arranged to "seal" or to achieve "seal" between them without the need for a separate "seal" element itself.

[0661] Ventilation port: (noun): A structure that allows air to flow from the inside of a mask or conduit into ambient air for clinically effective flushing of exhaled gases. For example, depending on the mask design and treatment pressure, clinically effective flushing can involve a flow rate from approximately 10 liters per minute to approximately 100 liters per minute.

[0662] The shape of the structure

[0663] Products according to this technology may include one or more three-dimensional mechanical structures, such as mask liners or impellers. The three-dimensional structure may be defined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe associated surface orientation, location, function, or some other characteristic. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, the seal-forming structure may include a face-contact (e.g., external) surface and separate non-face-contact (e.g., underside or internal) surfaces. In yet another example, the structure may include a first surface and a second surface.

[0664] To facilitate the description of the shape of the three-dimensional structure and surface, we first consider the cross-section through the surface of the structure at point p. See [link to documentation]. Figures 3B to 3F The diagram illustrates an example of a cross-section at point p on the surface, and the resulting planar curve. Figures 3B to 3F The diagram also illustrates the outward normal vector at point p. The outward normal vector at p points away from the surface. In some instances, we describe the surface from the perspective of an imaginary tiny person standing upright on it.

[0665] One-dimensional curvature

[0666] The curvature of a plane curve at point p can be described with a sign (e.g., positive, negative) and a magnitude (e.g., 1 / radius of the circle that just touches the curve at point p).

[0667] Positive curvature: If the curve at point p turns outward toward the normal, then the curvature at that point will be positive (if you imagine the little people leaving point p, they must walk uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to relatively small positive curvature). Such curves are usually called concave curves.

[0668] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if you imagine a little person leaving point p, they could walk horizontally without going up or down). See also Figure 3D .

[0669] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if you imagine a little person leaving point p, they must be going 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 usually called convex curves.

[0670] Curvature of a two-dimensional plane

[0671] A description of the shape at a given point on a two-dimensional surface according to this technique 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, for example, a relatively small magnitude. Figures 3B to 3F A planar curve can be an instance of such multiple cross-sections at a specific point.

[0672] Principal curvature and principal direction: The direction of the normal plane to which 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, the minimum curvature appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross-section along the principal direction. The principal curvature at point p is the curvature along the principal direction.

[0673] A region of a surface: a set of points connected on the surface. These points within a region can have similar characteristics, such as curvature or sign.

[0674] Saddle-shaped region: A region where the principal curvature has opposite signs at each point, i.e., one is positive and the other is negative (depending on the direction the imagined person is turning, they can be going uphill or downhill).

[0675] Vaulted region: A region where the principal curvature has the same sign at each point, such as both being positive ("concave vault") or both being negative ("convex vault").

[0676] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is not zero.

[0677] Planar region: A region of surface in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0678] Edge of a surface: the boundary or limit of a surface or area.

[0679] Path: In some forms of this technique, "path" will be considered to mean a path in a mathematical-topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, "path" can be described as a route or distance, including, for example, a set of points on a surface. (The path of an imagined person is the place where they walk on the surface, and is similar to a garden path).

[0680] Path length: In some forms of this technique, "path length" will be considered to mean the distance along the surface from f(0) to f(1), i.e., the distance along a path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length of an imagined person would be the distance they walk along the path on the surface).

[0681] Straight-line distance: Straight-line distance is the distance between two points on a surface, but it is independent of the surface itself. On a planar surface, there will exist a path with the same length as the straight-line distance between the two points. On a non-planar surface, there may not be a path with the same length as the straight-line distance between the two points. (For the imaginary reader, straight-line distance will correspond to distance "along a straight line".)

[0682] Space curves

[0683] 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 segment of three-dimensional space. Imagine a person walking along a space curve on one strand of a DNA helix. The typical human left ear contains the helix, which is a left-handed helix; see [link to relevant documentation]. Figure 3QThe typical human right ear includes a spiral, which is a right-handed spiral; see [link / reference]. Figure 3R . Figure 3S A right-handed helix is ​​shown. The edges of a structure, such as the edges of a membrane or impeller, can follow a space curve. Typically, a space curve can be described by the curvature and torsion at each point on the space curve. Torque is a measure of how the curve turns out of the plane. Torque has a sign and magnitude. The torsion at a point on a space curve can be characterized by reference to the tangent vector, normal vector, and double normal vector at that point.

[0684] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. The tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If you imagine a person flying along a curve and falling off their vehicle at a specific point, the direction of the tangent vector is the direction they would have traveled.

[0685] Unit normal vector: When an imagined person moves along a curve, the tangent vector itself also changes. The unit vector that changes in the same direction as the tangent vector is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0686] A double-normal unit vector is a vector that is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, [link to relevant documentation]). Figure 3P ) or optionally by left-hand rule ( Figure 3O To determine.

[0687] Oscillating plane: A plane containing both a unit tangent vector and a unit principal normal vector. See also Figure 3O and Figure 3P .

[0688] Torque of a space curve: Torque at a point on a space curve is the magnitude of the rate of change of the unit vector of the two normals at that point. It measures the degree to which the curve deviates from the osculating plane. A space curve lying in the osculating plane has zero torque. A space curve deviating relatively small from the osculating plane will have a relatively small torque magnitude (e.g., a gently sloping spiral path). A space curve deviating relatively large from the osculating plane will have a relatively large torque magnitude (e.g., a sharply sloping spiral path). See also Figure 3S Since T2 > T1, the amount of twist near the top coil of the spiral in Figure 3 is greater than that of the spiral in Figure 3. Figure 3S The twisting amplitude of the bottom coil of the spiral.

[0689] refer to Figure 3P According to the right-hand rule, a space curve oriented towards the right-hand binormal direction can be considered to have a right-hand positive twist (e.g., Figure 3S(The right-handed spiral is shown). A space curve that turns away from the direction of the right-hand double normal can be considered to have a right-handed negative twist (e.g., a left-handed spiral).

[0690] Similarly, refer to the left-hand rule (see...) Figure 3O A space curve oriented towards the left-hand double normal direction can be considered to have a left-hand positive twist (e.g., a left-hand spiral). Therefore, left-hand positive is equivalent to right-hand negative. See also Figure 3T .

[0691] hole

[0692] 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, [example missing]. Figure 3I The structure shown has a one-dimensional hole in the surface bounded by a planar curve.

[0693] The structure can have two-dimensional pores, such as pores defined by a surface. For example, an inflatable tire has two-dimensional pores defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have two-dimensional pores. See, for example, [link to relevant documentation]. Figure 3L padding and through Figure 3M and Figure 3N The example cross-section shows the inner surface defining the two-dimensional orifice. In yet another example, the conduit may include a one-dimensional orifice (e.g., at its inlet or outlet) and a two-dimensional orifice defined by a surface inside the conduit. See also Through Figure 3K The structure shown has a two-dimensional hole defined by the surface shown.

[0694] Other notes

[0695] This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of this patent document or patent disclosure by any person in the form it appears in the patent office documents or records, but otherwise reserves all copyright rights.

[0696] 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 stated or intermediate value within the stated range are included within this technology. The upper and lower limits of these intermediate ranges may be independently included within the intermediate range and also within this technology, but are subject to any express exclusions within the stated range. Where the stated range includes one or two limitations, the range excluding any one or both of those included limitations is also included within this technology.

[0697] Furthermore, where one or more values ​​described herein are implemented as part of this technology, it should be understood that, unless otherwise stated, such values ​​may be approximate and may be used for any suitable significant number to the extent that actual technical implementation may allow or require them.

[0698] Furthermore, as used herein, “approximately,” “substantially,” “about,” or any similar terms mean + / - 5% to 10% of the stated value.

[0699] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology pertains. While any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0700] When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0701] It must be noted that, unless the context clearly specifies otherwise, as used herein and in the appended claims, the singular forms “a”, “an” and “the” include their plural equivalents.

[0702] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. This document should not be construed as an admission that the art is not entitled to any earlier disclosure due to prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0703] The terms “comprises” and “comprising” should be understood as referring to elements, components or steps in a non-exclusive manner, indicating the possible presence or use of the mentioned elements, components or steps, or their combination with other elements, components or steps not expressly mentioned.

[0704] The headings used in the detailed embodiments are for convenience of the reader only and should not be used to limit the topics that can be found in this disclosure or the full text of the claims. The headings should not be used to interpret the claims or limit their scope.

[0705] Although the techniques described herein have been illustrated with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may imply specific details that are not required for practicing the techniques. For example, although the terms “first” and “second” may be used, they are not intended to indicate any order unless otherwise stated, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects thereof can be performed simultaneously or even concurrently.

[0706] Therefore, it should be understood that various modifications can be made to the illustrative examples and other devices can be designed without departing from the spirit and scope of this technology.

[0707] List of reference numerals

[0708]

Claims

1. A sealing structure for a patient interface, comprising a sealing region, wherein the sealing region is formed of a cushioning material, characterized in that, The cushioning material includes a patient-oriented elastomeric nonwoven material.

2. The sealing structure according to claim 1, wherein the sealing region has no elastic material.

3. The sealing structure according to claim 1, wherein the cushioning material is tensioned.

4. The sealing structure according to claim 1, wherein the elastomeric nonwoven material is incorporated into a flexible and / or elastic material.

5. The sealing structure according to claim 4, wherein the elastomeric nonwoven material is ultrasonically bonded to the flexible and / or elastic material.

6. The sealing structure according to claim 1, wherein the elastomeric nonwoven material is calendered.

7. The sealing structure according to claim 1, wherein the elastomeric nonwoven material is characterized in that its thickness is from 0.3 mm to 2 mm.

8. The sealing structure according to claim 1, wherein the elastomeric nonwoven material is characterized in that the fiber diameter is from 1 μm to 50 μm.

9. The sealing structure according to claim 1, wherein the elastomeric nonwoven material is characterized by a pilling resistance of at least level 3.

10. The sealing structure according to claim 1, wherein the elastomeric nonwoven material is characterized by a snag resistance of at least level 4.

11. The sealing structure according to claim 1, wherein the elastomeric nonwoven material is characterized by a tear resistance of 1N to 10N.

12. The sealing structure according to claim 1, wherein the elastomeric nonwoven layer is characterized by a tensile strength of 10 N to 50 N.

13. The sealing structure according to claim 1, wherein the elastomeric nonwoven layer is characterized by a pore size of 0.1 μm to 10 μm.

14. The sealing structure according to claim 1, wherein the elastomeric nonwoven layer is characterized in that the interfiber distance is 0.1 μm to 10 μm.

15. The sealing structure according to claim 1, wherein the elastomeric nonwoven layer is biocompatible.

16. The sealing structure according to claim 1, wherein the sealing structure further comprises one or more of a sealing flange, a supporting flange, a compression sealing portion, and a stretching portion, wherein at least one of the sealing flange, the supporting flange, the compression sealing portion, and the stretching portion is formed of the cushioning material.

17. The sealing structure according to claim 1, wherein the sealing structure is a pad.

18. The sealing structure according to claim 1, wherein the sealing structure is entirely formed of the cushioning material.

19. A positioning and stabilizing structure for a patient interface, comprising a cushioning material, characterized in that, The cushioning material includes an elastomer nonwoven material.

20. The positioning and stabilizing structure for a patient interface according to claim 19, wherein the elastomeric nonwoven material is incorporated into a flexible and / or elastic material, wherein the flexible and / or elastic material is a fabric material or a composite material.

21. The positioning and stabilizing structure of claim 20, wherein the flexible and / or elastic material is sandwiched between the elastomeric nonwoven material on both sides thereof.

22. The positioning and stabilizing structure of claim 20, wherein the elastomeric nonwoven material is sandwiched between the flexible and / or elastic materials on both sides thereof.

23. The positioning and stabilizing structure according to claim 19, characterized in that, The positioning and stabilizing structure also includes one or more head tubes, wherein cushioning material is present at least on the patient-facing side.

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