Airway for respiratory system

Abstract

This invention relates to a ventilation structure for a respiratory therapy system. In one embodiment, the ventilation structure includes a ventilation housing. The ventilation housing may define a flow path for exhausting airflow from the respiratory therapy system, an air inlet configured to allow airflow into the flow path, and an air outlet configured to allow airflow out of the flow path into ambient air. The ventilation housing may be configured such that the flow path includes a bend and deflection region in which the flow path changes direction by at least 90°. The ventilation housing may include a guide configured to guide the exhaust air radially or laterally outward from the ventilation housing.

Description

Cross-reference to related applications

[0001] This application claims priority to Australian Patent Application No. 2023903278, filed on 13 October 2023, which is incorporated herein by reference in its entirety. Background Technology 2.1 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.

[0004] 2.2 Description of relevant technologies

[0005] 2.2.1 The human respiratory system and its disorders

[0006] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0007] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into the venous blood and allowing carbon dioxide to move in opposite directions. The trachea divides into the left and right main bronchioles, which eventually branch into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branches of the airways lead to the respiratory bronchioles and ultimately to the alveoli. The alveolar regions of the lungs are where gas exchange occurs and are called the respiratory zones. See John B. West's *Respiratory Physiology*, 9th edition, Lippincott Williams & Wilkins, 2012.

[0008] A range of breathing disorders exist. Some disorders may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0009] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0010] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. The condition causes affected individuals to stop breathing, typically for periods ranging from 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can potentially cause cardiovascular disease and brain damage. This syndrome is a common disorder, particularly among middle-aged overweight men, although affected individuals may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0011] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to repetitive oxygen deprivation, CSR can be harmful. In some patients, CSR is associated with repetitive micro-arousals from sleep, causing severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0012] Respiratory failure is a general term for respiratory disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following disorders.

[0013] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0014] Obesity hyperventilation 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.

[0015] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These include increased air resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0016] 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 during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0017] Chest wall disorders are a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0018] A range of therapies have been used to treat or improve these conditions. Furthermore, other healthy individuals can utilize these therapies to prevent respiratory distress. However, these have many drawbacks.

[0019] 2.2.2 Treatment

[0020] 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.

[0021] 2.2.2.1 Respiratory pressure therapy

[0022] Respiratory pressure therapy is the application of supplying air to the inlet of the airway 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).

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

[0024] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to assist breathing and / or maintain adequate oxygen levels by performing some or all of the work of breathing. Ventilation support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure, such as forms like OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these therapies.

[0025] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0026] 2.2.2.2 Flow Therapy

[0027] Not all respiratory therapies are designed to deliver a prescribed therapeutic pressure. Some respiratory therapies are designed to deliver a prescribed respiratory volume by delivering an inspiratory flow rate profile (possibly superimposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and the respiratory therapy may supplement only the patient's own spontaneous breathing with a regulated or enriched flow of gas. In one example, high-flow therapy (HFT) delivers a continuous, heated, humidified flow of air to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that remains approximately constant throughout the respiratory cycle. This therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow rate of air at the airway inlet improves ventilation efficiency by flushing or washing out exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as dead space therapy (DST). Other benefits may include increased warmth and humidification (which may be beneficial in secretion management) and the possibility of appropriately increasing airway pressure. As an alternative to constant flow, therapeutic flow can follow a curve that varies throughout the respiratory cycle.

[0028] Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. Doctors can prescribe a continuous flow of oxygen-enriched gas into the patient's airway at a specified oxygen concentration (from 21%, the oxygen fraction in ambient air, to 100%) and a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0029] 2.2.3 Respiratory Therapy System

[0030] 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.

[0031] 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.

[0032] 2.2.3.1 Patient Interface

[0033] 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 mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy to be applied, the patient interface can form a seal with an area such as 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.

[0034] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not maintain adequate pressure. Mask systems for underwater swimming or diving can be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient.

[0035] Some masks may be clinically disadvantageous for this technology, such as when they block airflow through the nose and only allow it through the mouth.

[0036] If some masks require the patient to insert a portion of the mask structure into their mouth to form and maintain a seal through their lips, then these masks may be uncomfortable or impractical for this technology.

[0037] Some face masks may be impractical to use while sleeping, such as when lying on your side in bed with your head on a pillow.

[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 considerably between individuals. Because the head comprises bones, cartilage, and soft tissues, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during the course of a breathing therapy session.

[0039] Due to these challenges, some face shields suffer from one or more of the following drawbacks: obtrusive, unsightly, expensive, poor fit, difficult to use, and / or uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized face shield can lead to reduced adherence, decreased comfort, and poorer patient outcomes. Face shields designed solely for pilots, those designed as part of personal protective equipment (e.g., filtering face shields), SCUBA face shields, or those used for administering anesthetics are tolerable for their original applications; however, such face shields can still be unintentionally uncomfortable when worn for extended periods (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment. This is especially true if the face shield 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. Because patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean it, and this can affect patient adherence.

[0041] While masks designed for other applications (such as pilots) may not be suitable for treating sleep-disorder breathing, masks designed for treating sleep-disorder breathing may be suitable for other applications.

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

[0043] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0044] 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, an RPT device can also function as a flow-based therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0045] 2.2.3.3 Air Circuit

[0046] An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation. In other cases, a single-branch air circuit is used for both inhalation and exhalation.

[0047] 2.2.3.4 Humidifier

[0048] Delivering airflow without humidification can lead to airway dryness. Using a humidifier with an RPT device and patient interface to generate humidified air minimizes dryness of the nasal mucosa and increases patient airway comfort. Additionally, in cooler climates, warm air applied to the area around the patient interface and face is generally more comfortable than cold air. Therefore, humidifiers typically have the ability to both heat and humidify the airflow.

[0049] 2.2.3.5 Ventilation technology

[0050] Some forms of therapeutic systems may include a vent to allow the removal of exhaled carbon dioxide. The vent allows gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the outside of the patient interface (e.g., into the environment).

[0051] The vent may include an opening through which gas can flow when a mask is used. Many such vents are noisy. Others may become blocked during use, thus providing insufficient clearance. Some vents may, for example, disturb the sleep of the patient's bed partner by causing noise or congested airflow. One object of this technology is to provide an improved vent to overcome one or more of the aforementioned disadvantages.

[0052] ResMed Limited has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; 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.

[0053] The noise level of the existing face mask (ISO 17510-2:2007, pressure of 10 cmH2O at 1m)

[0054] (*Only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0055] The sound pressure levels for each object are listed below.

[0056] Summary of the Invention

[0057] 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.

[0058] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0059] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0060] One aspect of certain forms of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0061] Certain aspects of this technology can provide a ventilation structure with lower noise than existing ventilation structures.

[0062] Certain aspects of this technology can be configured to provide a connection member that enables the connection between the patient interface and the RPT device.

[0063] Certain aspects of this technology can provide an aesthetically pleasing connecting member.

[0064] Certain aspects of this technology can provide a compact connector. In some forms of this technology, the compact connector may include a venting structure.

[0065] Certain aspects of this technology can be configured to provide a ventilation structure that discharges gases with low turbulence.

[0066] Some aspects of this technology may include providing an RPT system that reduces the weight and / or noise of components used with patient interfaces containing adhesive seals.

[0067] One aspect of this technology relates to a ventilation structure for a respiratory therapy system. In some forms, the ventilation structure may be part of a connecting member for the respiratory therapy system.

[0068] One form of this technology includes a ventilation structure for a respiratory therapy system, the ventilation structure including a ventilation housing that defines a flow path for exhausting airflow from the respiratory therapy system.

[0069] In some forms, the ventilation structure may include a ventilation inlet configured to allow airflow into the flow path and a ventilation outlet configured to allow airflow out of the flow path into ambient air, wherein the ventilation housing is configured such that the flow path includes a bend and turn region in which the flow path changes direction.

[0070] In some forms, the vent housing is configured such that the flow path includes a bend and turn region in which the flow path changes direction by at least 90°. In other forms, the vent housing is configured such that, through this turn region, the flow path changes direction to a substantially opposite direction. For example, the vent housing may be configured such that the flow path includes a bend and turn region in which the flow path changes direction by an angle substantially 180°.

[0071] In some forms, a ventilation structure is provided for use in respiratory therapy systems.

[0072] In some forms, the ventilation structure may include a ventilation housing that defines a flow path for exhausting airflow from the respiratory therapy system. In some forms, the ventilation structure may also include an air inlet configured to allow airflow into the flow path and an air outlet configured to allow airflow out of the flow path into ambient air.

[0073] In some forms, the vent housing can be configured such that the flow path includes a bend and turn region in which the flow path changes direction by at least 90°; and a guide is provided at or near the vent outlet, wherein the guide is configured to direct the airflow radially or laterally outward from the vent housing.

[0074] In some configurations, the flow guide can be located within or on the flow path upstream of the vent outlet, while in others, it can be located downstream of the vent outlet.

[0075] In some forms, the guide may include one or more of the following: a) a curved structure; b) a continuous curvature; c).

[0076] In some forms, the air guide may: a) be disposed on the outer surface of the outer connection portion; b) extend in a continuous annular shape around the outer surface of the outer connection portion; c) be configured to guide the airflow in a direction having a component perpendicular to the longitudinal axis and a component parallel to the longitudinal axis; d) be configured to guide the airflow at an angle of 5 degrees to 85 degrees relative to the longitudinal axis of the ventilation structure.

[0077] One form of this technology relates to a patient interface, which in some forms may include: an inflation chamber capable of being pressurized to a therapeutic pressure at least 6 cmH2O above ambient air pressure, the inflation chamber including an inflation chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for patient breathing; a sealing formation structure constructed and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet, the sealing formation structure having an opening therein such that an airflow at the therapeutic pressure is delivered to at least one inlet of the patient's nostril, the sealing formation structure being constructed and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use; and a ventilation structure as described above.

[0078] In some forms, the ventilation structure allows the patient's exhaled gases to flow continuously from the interior of the inflation chamber into the environment, and the size and shape of the ventilation structure are designed to maintain therapeutic pressure in the inflation chamber during use.

[0079] One form of this technology relates to a connecting member configured to fluidly connect an air circuit to a patient interface in a respiratory therapy system.

[0080] In some forms, the connecting member may include: a connecting housing comprising a first end configured for direct or indirect fluid connection to an air circuit and a second end configured for direct or indirect fluid connection to a patient interface; and a ventilation structure as described above.

[0081] In one embodiment, a connecting member is provided configured to directly or indirectly fluidly connect an air circuit to a patient interface in a respiratory system. The connecting member includes: a connecting housing configured to fluidly connect the air circuit to the patient interface, the connecting housing including: a first end configured to directly or indirectly fluidly connect to the air circuit; a second end configured to directly or indirectly fluidly connect to the patient interface; an outer connecting portion; and an inner connecting portion.

[0082] In some forms, the outer connecting portion can rotate relative to the inner connecting portion and the outer connecting portion about their respective longitudinal axes.

[0083] In some forms, the connecting member may further include: a venting structure for discharging air from the inner connecting portion into the ambient air, the venting structure including: a vent housing including at least a portion of the outer connecting portion, wherein the outer connecting portion defines only at least a portion of a flow path for discharging airflow, and wherein the vent housing defines: a vent inlet configured to allow airflow from inside the connecting member into the flow path; and a vent outlet configured to allow airflow to exit the vent housing into the ambient air, wherein the vent outlet includes a guide at or near the vent outlet, wherein the guide is configured to guide the airflow radially or laterally outward from the vent housing.

[0084] In some forms of this technology, the connecting member may include one or more inwardly tapering flow paths, thereby reducing the cross-sectional area of ​​the flow path between the vent inlet and the vent outlet.

[0085] One form of the technology includes a ventilation structure for a respiratory therapy system, the ventilation structure including a ventilation housing defining a flow path for exhausting an airflow from the respiratory therapy system, a ventilation inlet configured to allow the airflow to enter the flow path, and a ventilation outlet configured to allow the airflow to leave the flow path and enter ambient air, wherein the ventilation housing is configured such that the flow path includes a bend and turn region in which the flow path changes direction by at least 90°.

[0086] One form of the technology includes a ventilation structure for a respiratory therapy system, the ventilation structure including a ventilation housing defining a flow path for exhausting an airflow from the respiratory therapy system, a ventilation inlet configured to allow the airflow into the flow path, and a ventilation outlet configured to allow the airflow to leave the flow path and enter ambient air, wherein the ventilation housing is configured such that the flow path includes a bend and deflection region in which the flow path changes direction, and wherein the ventilation housing includes a guide adjacent to the ventilation outlet configured to guide the airflow away from the body of the ventilation housing.

[0087] In the example, the inner path surface in the turning area may have a curved cross-sectional shape, such as an arc shape.

[0088] In the example, the vent housing may include multiple partitions that form multiple flow paths therebetween.

[0089] One form of the technology includes a connecting member configured to directly or indirectly fluidly connect an air circuit to a patient interface of a respiratory therapy system. The connecting member includes a connecting housing comprising a first end configured to directly or indirectly fluidly connect to the air circuit and a second end configured to directly or indirectly fluidly connect to the patient interface, and a ventilation structure according to any of the above-described technologies, configured to allow a portion of the air in the connecting housing to exit into ambient air.

[0090] In the example: a) the connecting housing includes an outer connecting portion and an inner connecting portion; b) the outer connecting portion is rotatable relative to the inner connecting portion about a mutual longitudinal axis; and / or c) the outer connecting portion includes a first end portion, and the inner connecting portion includes a second end portion.

[0091] One form of the technology includes a connecting member configured to directly or indirectly fluidly connect an air circuit to a patient interface in a respiratory system. The connecting member includes a connecting housing configured to fluidly connect the air circuit to the patient interface. The connecting housing includes a first end configured to directly or indirectly fluidly connect to the air circuit, a second end configured to directly or indirectly fluidly connect to the patient interface, an outer connecting portion, and an inner connecting portion. The outer connecting portion is rotatable relative to the inner connecting portion and the outer connecting portion about a mutual longitudinal axis. The connecting member further includes a ventilation structure for discharging air from the inner connecting portion into ambient air. The ventilation structure includes a ventilation housing including at least a portion of the outer connecting portion. The outer connecting portion defines at least a portion of a flow path for discharging airflow. The ventilation housing defines a ventilation inlet configured to allow airflow from inside the connecting member into the flow path and a ventilation outlet configured to allow airflow out of the ventilation housing into ambient air. The ventilation structure further includes a noise attenuation structure for reducing noise generated by the airflow between the outer connecting portion and the inner connecting portion.

[0092] In the example: a) the flow path formed on the inner surface of the inner connection portion is substantially parallel to each other's longitudinal axes; b) the portion of the flow path defined by the outer connection portion is a first flow path portion, wherein the vent housing also includes a portion of the inner connection portion, wherein the inner connection portion and the outer connection portion define a second flow path portion therebetween, wherein the flow path includes the second flow path portion, and wherein the second flow path portion receives airflow from the first flow path portion and delivers the airflow to the vent outlet; c) the second flow path portion includes a bend turning region in which the flow path changes direction by at least 90°; d) through the turning region, the flow path changes direction to substantially opposite directions; e) through the turning region, the flow path changes direction by an angle of substantially 180°; f) a first end is configured to be directly fluidly connected to a first portion of the air circuit, and a second end is configured to be directly fluidly connected to a second portion of the air circuit; g) the outer connection portion includes the first end, and the inner connection portion includes the second end.

[0093] One form of the technology includes a connecting member configured to directly or indirectly fluidly connect an air circuit to a patient interface of a respiratory therapy system. The connecting member includes a connecting housing configured to fluidly connect the air circuit to the patient interface. The connecting housing includes a first end configured to directly or indirectly fluidly connect to the air circuit and a second end configured to directly or indirectly fluidly connect to the patient interface. The connecting member further includes a venting structure for discharging air from an internal volume of the connecting housing. The venting structure includes a venting housing, which includes at least a portion of the connecting housing, and a plurality of partitions within the venting housing that form a plurality of flow paths therebetween. Each flow path includes a venting inlet configured to receive an airflow and a venting outlet configured to allow airflow to exit into ambient air. The flow paths are curved around the connecting housing.

[0094] In the example: a) the vent inlet and vent outlet are circumferentially offset around the connecting housing; b) each in the flow path tapers inward from the vent inlet toward the vent outlet; c) the vent inlet is positioned closer to a first end of the connecting housing; d) the vent outlet is positioned closer to a second end of the connecting housing; e) the connecting housing includes an outer connecting portion and an inner connecting portion; f) the outer connecting portion is rotatable relative to the inner connecting portion about a mutual longitudinal axis; g) the vent housing includes at least a portion of the outer connecting portion; h) the vent housing includes at least a portion of the inner connecting portion; i) a separator is formed on the outer surface of the inner connecting portion; j) the first end is configured to be directly fluidly connected to a first portion of the air circuit, and the second end is configured to be directly fluidly connected to a second portion of the air circuit; k) the mushroom-shaped portion includes a deflection region configured to change the direction of the airflow to substantially opposite directions; and / or l) through the deflection region, the airflow changes direction by an angle of substantially 180°.

[0095] One form of this technology provides a system for treating respiratory disorders.

[0096] One form of this technology provides a system for treating respiratory disorders, the system including a patient interface and a connecting member including a ventilation structure.

[0097] In the example, the system may also include a first air circuit having a first end attached to a patient interface and a second end attached to a connecting member; a respiratory pressure therapy device (RPT device) configured to generate a positive pressure breathable gas flow; and a second air circuit having a first end attached to the connecting member and a second end attached to the RPT device.

[0098] In the example, the ventilation structure may include at least one flow path having a bend and turn region in which the flow path changes direction by at least 90°; and a guide configured to direct the ventilated airflow outward away from the connecting member.

[0099] In the example: a) a first air circuit may be detachably attached to the patient interface and / or the connecting member; b) a second air circuit may be detachably attached to the connecting member and / or the RPT device; c) the second air circuit may include a cuff; d) a flow guide may be configured to direct airflow outward around the cuff; e) the ventilation structure may include a ventilation inlet and a ventilation outlet, wherein the ventilation inlet is circumferentially offset relative to the ventilation outlet around the connecting housing; f) the ventilation inlet may be located closer to the second air circuit than the first air circuit; g) the ventilation outlet may be configured to direct exhaust airflow outward, and in a direction more towards the second air circuit than the patient interface; h) the connecting member may include an outer connecting portion and an inner connecting portion.

[0100] In the example, this technology can be used with a patient interface that includes an adhesive seal.

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

[0102] Of course, some of these aspects can form sub-aspects of this technology. Furthermore, these sub-aspects and / or individual sub-aspects and / or aspects can be combined in various ways and also constitute additional aspects or sub-aspects of this technology.

[0103] 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

[0104] This technology is illustrated by way of example rather than limitation in the various figures of the accompanying drawings, wherein similar reference numerals refer to similar elements, including:

[0105] 4.1 Breathing Therapy System

[0106] Figure 1A A system including a patient 1000 wearing a patient interface 3000 in the form of a nose pillow, which receives a positive pressure air supply from an RPT device 4000. The air from the RPT device 4000 is conditioned 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.

[0107] Figure 1B A system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask is shown, which receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0108] 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.

[0109] 4.2 Respiratory System and Facial Anatomy

[0110] Figure 2AA 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.

[0111] 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.

[0112] 4.3 Patient Interface

[0113] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0114] Figure 3B A patient interface in the form of a nasal cannula according to the present technology is shown.

[0115] 4.4RPT device

[0116] Figure 4A An RPT device of one form according to the present technology is shown.

[0117] 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.

[0118] 4.5 Humidifier

[0119] Figure 5A An isometric view of one form of humidifier according to the present technology is shown.

[0120] 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.

[0121] 4.6 Respiratory waveform

[0122] Figure 6A A typical breathing waveform model of a person sleeping is shown.

[0123] 4.7 Vent

[0124] Figure 7A A perspective view of one form of connecting member according to the present technology is shown.

[0125] Figure 7B It shows Figure 7A Exploded perspective view of the connecting components.

[0126] Figure 7C It shows Figure 7A Top view of the connecting components.

[0127] Figure 7D It shows Figure 7A A bottom view of the connecting components.

[0128] Figure 7E It shows Figure 7A The side view of the connecting member. The side view of the connecting member is the same from all sides.

[0129] Figure 7F It shows along Figure 7E A cross-sectional view of plane AA.

[0130] Figure 8A An exploded perspective view of one form of connecting member according to the present technology is shown.

[0131] Figure 9A An exploded perspective view of one form of connecting member according to the present technology is shown.

[0132] Figure 9B It shows Figure 9A The connecting components, wherein the inner connecting part is connected to the outer connecting part.

[0133] Figure 9C It shows Figure 9A A cross-sectional view of the inner connecting portion, the cross-section being cut through a plane labeled AA.

[0134] Figure 9D It shows Figure 9A A cross-sectional view of the outer connecting portion, which is cut through the plane labeled AA.

[0135] Figure 9E It shows Figure 9B A cross-sectional view of the assembled connecting components, the cross-section being cut through a plane marked BB.

[0136] Figure 9F A side view of the connection member connecting the connection port to the air circuit is shown in use.

[0137] Figure 9G A side view of the connecting member that connects the first air circuit to the second air circuit during use is shown.

[0138] Figure 9H The image shown is intercepted through the plane labeled CC. Figure 9F and 9GA partial cross-sectional side view of the connecting component.

[0139] Figure 9I It shows Figure 9H A close-up view of the area marked D.

[0140] Figure 10A A side view of one form of adhesive seal forming structure according to the present technology is shown.

[0141] Figure 10B A top view of one form of adhesive seal according to the present technology is shown.

[0142] Figure 10C A rear view of a patient interface with an adhesive seal, according to one form of the present technology, is shown.

[0143] Figure 10D An exploded view of a patient interface with an adhesive seal, according to one form of the present technology, is shown. Detailed Implementation

[0144] Before describing this technology in more detail, it should be understood that this technology is not limited to the specific examples that may vary as described herein. It should also be understood that the terminology used in this invention is for the purpose of describing the specific examples discussed herein and is not intended to be limiting.

[0145] The following description provides various examples of things that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. Furthermore, in any example, any single feature or combination of features can constitute another example.

[0146] 5.1 Therapy

[0147] 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.

[0148] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0149] In some examples of this technology, mouth breathing is restricted, constrained, or prevented.

[0150] 5.2 Respiratory Therapy System

[0151] 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.

[0152] 5.3 Patient Interface

[0153] According to one aspect of the present technology, the noninvasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component provides one or more functional aspects. In use, the sealing-forming structure 3100 is arranged to surround the inlet of the patient's airway to maintain positive pressure at the inlet of the patient's airway. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0154] The unsealed patient interface 3800 in the form of a nasal cannula includes nasal cannulas 3810a and 3810b, which deliver air to the individual nostrils of a patient 1000 via corresponding orifices in their tips. Such nasal cannulas typically do not form a seal with the inner or outer skin surface of the nostril. Air can be delivered to the nasal cannula 3800 via one or more air supply lumens 3820a and 3820b coupled to it. Lumens 3820a and 3820b guide air from the nasal cannula 3800 to a respiratory therapy device via an air circuit. The unsealed patient interface 3800 is particularly suitable for delivery of flow therapy, where the RPT device generates an airflow at a controlled flow rate rather than a controlled pressure. An excess airflow escapes into the environment through a “vent” at the unsealed patient interface 3800, which is a pathway between the end of cannula 3810a and 3810b of the cannula 3800 through the patient’s nostrils to the atmosphere.

[0155] 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.

[0156] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to the environment.

[0157] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to the environment.

[0158] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to the environment.

[0159] 5.3.1 Sealing Formation Structure

[0160] 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 region on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0161] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0162] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material (e.g., silicone rubber).

[0163] The sealing structure 3100 according to this technology can be made of a soft, flexible, elastic material (such as silicone).

[0164] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each sealing formation structure being configured to correspond to a different size and / or shape range. For example, the system may include one type of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, while another is suitable for small-sized heads but not for large-sized heads.

[0165] 5.3.1.1 Adhesive seals

[0166] Some forms of this technology include a seal-forming structure 3100 configured to be adhered to one or more areas of a patient's face by an adhesive to form a seal with an area of ​​the patient's face surrounding one or more inlets in the patient's airway. The seal-forming structure 3100 in Figure 10 is an example of a seal-forming structure configured to seal around the nasal airway of a patient 1000. However, in alternative forms of this technology (not shown in the figures), the seal-forming structure may be configured to seal around the mouth of the patient 1000. The seal-forming structure may also be configured to seal both the nasal airway and mouth of the patient 1000.

[0167] The adhesive-based attachment of the seal-forming structure 3100 to the patient's face allows for a highly airtight seal. It has been found that some forms of adhesive-based seals allow for significantly less leakage than conventional compression seals maintained on the face via a headgear. One reason for this is that the seal-forming structure 3100, when adhered to the patient's face, is flexible enough to maintain the seal even as the patient's face or skin moves, even with dynamic twisting of the face. Such movement would cause leakage in conventional compression seals. The shape of the face can change particularly when the patient moves from an upright position to a lying position, and between lying positions (e.g., on the back (supine), in front (prone), or on the side (lateral)).

[0168] Traditional compression seals present a trade-off between comfort and leakage. A greater holding force (typically applied by the tension of the headgear straps) that keeps the patient interface on the face reduces the risk of leakage but makes the interface less comfortable to wear and more likely to leave marks on the patient's face. However, if the holding force is too low, leakage will occur, especially under high therapeutic pressures. Furthermore, for any given patient interface, the appropriate level of interference to balance these considerations can vary around the perimeter of the seal and also between patients due to variations in individual facial shapes. Adhesive-based seals can avoid these difficulties because they can more effectively conform to the shape of the patient's face, especially if the seal-forming structure is sufficiently flexible and can adhere to the skin with a consistent holding force around its perimeter.

[0169] It was also observed that, compared to some other types of patient interfaces, the adhesive-based attachment of the seal-forming structure 3100 to the patient's face resulted in less occlusion of the patient's nostrils. As will be described, the exemplary form of the seal-forming structure 3100 of this technology is configured to adhere around the flange of the patient's nose. This means that essentially the entire nostril area is available to receive incoming gas. Furthermore, in the technical form where the seal-forming structure 3100 is capable of bending with the patient's face, the nose expands slightly freely due to the incoming pressurized gas, which further increases the area of ​​the nostrils. These effects make it easier for the patient to breathe when using the patient interface 3000 according to the technical aspects described herein, compared to some conventional patient interfaces. For example, patient interfaces using compression seals may push inward on the nostrils, making them more difficult to expand outward, and some patient interfaces are constructed such that both the inner and outer surfaces of the nose are contained within a pressurized inflation chamber. This means there is no pressure difference between the inner and outer surfaces of the nose, and therefore no inflation effect occurs. Conversely, some forms of the technology described in this article create a seal around the flange, resulting in a pressure difference between the inner and outer surfaces of the nostril, thus achieving this air-expansion effect. This benefit may be particularly significant for patients with narrow nostrils.

[0170] In a face mask system that includes adhesive seals, it is advantageous to have a relatively light weight for the patient interface 3000, the associated air circuit 4170, and the ventilation structure 6000 to reduce the force exerted on the wearer's face during use. For example, as Figure 10C As shown, it may be advantageous to provide a patient interface with a non-removable air circuit 4170. In this way, the patient interface can be constructed without the weight of decoupling structures such as the connection port 3600 or a rotating shaft. In other examples of this technology, it may be advantageous to provide a patient interface 3000 with a compact connection port 3600 configured to receive the air circuit 4170.

[0171] The mask system and patient interface, including the adhesive seal, may also have an air circuit 4170 with a smaller diameter than the conventional air circuit 4170, such as an inner bore or a conduit with a diameter of about 9 mm to about 13 mm (inclusive), such as about 11 mm. In contrast, the inner bore or diameter of the conventional air circuit 4170 is typically about 17 mm to about 21 mm (inclusive), such as about 19 mm; some slim air circuits may have an inner bore or diameter between about 13 mm and 17 mm, such as about 15 mm.

[0172] Using a smaller, lighter air circuit 4170 can advantageously further reduce the load or force on the patient interface 3000. In these examples of the art, the use of the connecting member 7000 can advantageously connect a smaller diameter, lighter air circuit 4170 to a standard, larger diameter air circuit 4170, such as the air circuit conventionally supplied with the RPT device 4000.

[0173] In examples of this technology using adhesive seals, it may be advantageous for the length of the air circuit 4170 attached to the patient interface 3000 to be between about 200 mm and about 400 mm, such as about 300 mm. In some examples, at one end of the air circuit (away from the patient interface), the air circuit may be configured to be attached to a connection member 7000 as described herein, which may provide, for example, a ventilation structure 6000, a decoupling structure, and / or a connection to a second air circuit that is attached in use to an RPT device 4000 configured to generate a breathable gas flow to one or more airways of a patient.

[0174] Other examples of adhesive seals are described in PCT Publication WO / 2023 / 015340, the contents of which are incorporated herein by reference in their entirety.

[0175] 5.3.1.1.1 Adhesive Surface

[0176] The sealing structure 3100 is configured to be fixed to a therapeutically effective location abutting the patient's face by an adhesive. In some forms of this technology, in addition to one or more adhesives, the sealing structure may also be configured to adhere to the patient's face by vacuum-induced attachment.

[0177] In one form, the sealing forming structure 3100 includes a region having at least one adhesive surface 3102. Figure 10C An exemplary adhesive surface 3102 is illustrated in one form of the present technology.

[0178] An adhesive is applied to an adhesive surface 3102, and in use, the adhesive surface 3102 contacts the patient’s face, such that the adhesive adheres the adhesive surface 3102 of the sealing structure 3100 to the patient’s face.

[0179] In a preferred form of this technology, the sealing-forming structure 3100 is configured such that the shape of the adhesive surface 3102 substantially matches or resembles the shape of the area of ​​the patient's face to which the sealing-forming structure 3100 is attached in use. As will be explained in more detail later, in some forms, the sealing-forming structure 3100 may be configured to substantially match / resemble the shape of an area of ​​a particular patient's face, i.e., the sealing-forming structure 3100 may be customized for an individual patient. Customizing the sealing-forming structure 3100 in a patient interface 3000 of the type described herein may be more commercially feasible than in other types of patient interfaces because the small coverage area of ​​the sealing-forming structure 3100 makes it a relatively small component, and the sealing-forming structure 3100 may be able to be cut from a flat sheet of material (such as adhesive tape), thereby reducing the relative manufacturing cost for an individual patient. Alternatively, the sealing-forming structure 3100 may be configured to substantially complement the shape of an appropriate area of ​​a general face, or the shape of a general face of a subgroup of people (e.g., based on the size or type of the face shape). Alternatively, the sealing structure 3100 may be formed of a material and be shaped to make the sealing structure 3100 flexible enough to take the shape of the area of ​​the patient’s face to which it is attached during use.

[0180] The sealing-forming structure 3100 and / or adhesive surface 3102 are shaped to substantially match / appear to the patient's facial area to which the sealing-forming structure 3100 is adhered, or are shaped to be flexible enough to deform. One advantage of doing so is that this avoids pulling of the adhesive surface 3102 onto the underlying skin when the patient interface 3000 is in use. This significantly improves patient comfort by eliminating uneven stress generated by the adhesive applying shear stress to the skin.

[0181] In addition, a smaller amount of adhesive can be used to provide the adhesive force required to hold the seal-forming structure 3100 against the patient’s face, rather than the adhesive force required in other cases, because the adhesive does not exert force when the skin is pulled laterally across the face.

[0182] The area of ​​the seal-forming structure 3100 to which the adhesive is applied can be considered the target seal-forming area. In one form, the adhesive is located on an annular area surrounding the outer edge of the seal-forming structure 3100. This minimizes the coverage area of ​​the seal-forming structure 3100 on the patient's face, thereby reducing the volume of the patient interface 3000 and its inconvenience to the patient 1000.

[0183] The close proximity of the sealing-forming structure 3100 and the presence of the adhesive on the skin surface may lead to the accumulation of sweat from the underlying skin and / or interaction with the adhesive. When the patient interface 3000 will be worn for extended periods, such as during sleep, the accumulation of sweat may be inconvenient. Therefore, the smaller the area of ​​the target sealing-forming region and / or the area covered by the sealing-forming structure 3100, the less inconvenience it will cause to the patient 1000.

[0184] 5.3.1.2 Adhesive Form

[0185] This technology provides a patient interface 3000 including a sealing formation structure 3100, the sealing formation structure 3100 including at least one adhesive surface configured to adhere to a region surrounding the patient's airway inlet on the patient's face in use to form a seal.

[0186] Any suitable adhesive can be used, and suitable properties of the adhesives used in certain forms of this technology are described in the following paragraphs. It should be understood that, unless otherwise expressly stated, the forms of this technology are not limited to certain adhesives. Furthermore, in some forms, the adhesive may comprise one or more constituent adhesive materials.

[0187] In some forms, the adhesive applied to the adhesive surface of the sealing structure 3100 is a skin-adhesive adhesive, whose adhesive strength is sufficient to maintain adhesion when forces of the direction and magnitude typically encountered during use of the patient interface 3000 are applied, so that the sealing structure 3100 does not become too easily detached during normal use. Similarly, the adhesive strength should not be so great that the patient interface 3000 cannot be removed without causing trauma to the skin after treatment is discontinued.

[0188] In some forms, the adhesive can be configured to maintain the desired level of adhesion to the facial skin, despite the presence of moisture (e.g., sweat) and / or heat on the patient's skin.

[0189] The expectation is that the adhesive will adhere to the skin, regardless of the contours of the patient's skin to which it adheres, such as whether there are wrinkles, ridges, or flat areas.

[0190] The adhesive is expected to be odorless (as far as the patient can normally perceive) and colorless or aesthetically pleasing in color. Furthermore, some forms of this technique utilize adhesives that leave little or no residue after removal from the skin. Adhesives lacking these properties may be used in some forms of this technique and may be effective, but may be undesirable for the patient.

[0191] Some adhesives require certain steps to treat the surface to which the adhesive will adhere in order to form an effective bond. For example, some adhesives require the patient's skin to be wiped with a cleaning fluid such as alcohol before use. This need for treatment can be undesirable because it requires an extra step from the patient, who may not be able to effectively treat their skin, especially when fatigued. Therefore, some forms of this technology use adhesives that do not require such surface preparation.

[0192] The desired outcome is the use of an adhesive that adheres effectively to the skin but not so well to the hair. This avoids patient discomfort when the sealant is removed along with the hair.

[0193] The adhesives used on 3M Nexcare™ tape and Leukoplast tape are examples of suitable adhesives that have one or more of the aforementioned properties and are used in some form of this technology. For example, a rubber zinc oxide adhesive can be used. In other forms, other adhesive tapes are used. The adhesive on the adhesive tape is provided on the substrate (i.e., the tape), which can advantageously be used as a seal forming structure 3100 or a part thereof, or can be readily attached to the seal forming structure 3100.

[0194] In other forms of this technology, the adhesive used to seal the forming structure 3100 can be deposited directly onto the adhesive surface 3102, for example, as described below. The adhesive can be deposited onto the adhesive surface as part of the manufacturing process. Alternatively, in some forms, the patient interface 3000 can be supplied in a manner where the adhesive has not yet been applied to the adhesive surface, and the patient (or clinician) applies the adhesive to the surface prior to use.

[0195] 5.3.1.2.1 Fluid Adhesives

[0196] In some forms of this technology, the patient interface 3000 includes a sealing formation structure 3100 having at least one surface to which a fluid adhesive can be applied to form an adhesive surface.

[0197] 5.3.1.2.2 Spraying Adhesive

[0198] In an alternative form of this technology, the patient interface 3000 includes a sealing formation structure 3100 having at least one surface on which a sprayable adhesive can be sprayed to form an adhesive surface.

[0199] 5.3.1.2.3 Adhesive tape section

[0200] In an alternative form of this technology, the patient interface 3000 includes one or more adhesive tape segments configured to provide at least one sealing surface of at least one sealing structure. Each adhesive tape segment may include a first adhesive on one side and a second adhesive on the other side. The first adhesive may be configured to secure the adhesive tape segment to the sealing structure 3100. The second adhesive may be configured to secure the sealing structure 3100 against the skin of the patient 1000. Thus, the second side of the adhesive tape segment provides an adhesive surface.

[0201] The adhesive tape section may be provided with a removable layer to protect the first and second adhesives from contamination and / or loss of adhesion before the sealed forming structure 3100 is assembled.

[0202] 5.3.1.2.4 Removable Layers

[0203] In some forms, the patient interface 3000 may also include a removable layer 3104 that is removably attached to and covers the adhesive surface 3102. The removable layer 3104 can be removed before the patient interface 3000 is positioned for a sealed contact with the patient's face.

[0204] The removable layer 3104 can be used to protect the adhesive on the adhesive surface 3102 from contamination, unintentional adhesion to other surfaces, and / or loss of adhesion when the patient interface 3000 is not in use. The removable layer 3104 can be attached to the adhesive surface 3102 by adhesive when the patient interface 3000 is transported, stored, or otherwise not in use, but can be configured to form a generally weak attachment to the adhesive surface 3102, for example, by having a smooth surface in contact with the adhesive surface 3102. The removable layer 3104 can be removed by the patient 1000 before the patient interface 3000 is put on. Figure 10D An example of a patient interface 3000 including a removable layer 3104 is shown.

[0205] In one embodiment, the removable layer 3104 may include tabs 3105T and 3106T that extend beyond the coverage area and / or periphery of the sealing structure 3100. The patient 1000 may peel off the removable layer 3104 by grasping the tabs 3104T and pulling the removable layer 3104 away from the sealing structure 3100.

[0206] In one form, the removable layer 3104 comprises two parts—a first part 3105 and a second part 3106, as shown below. Figure 10D As shown. A first portion 3105 of the removable layer 3104 can be configured to peel off toward a first side of the patient's face, and a second portion 3106 of the removable layer 3104 can be configured to peel off toward a second side (which may be opposite to the first side). The first portion 3105 may have a first tab 3105T, and the second portion 3106 may have a second tab 3106T. When the first portion 3105 and the second portion 3106 are attached to the adhesive surface 3102, the first tab 3105T and the second tab 3106T may extend in different, for example, opposite directions. The patient 1000 can peel off the first portion 3105 by grasping the first tab 3105T and pulling in the relevant direction. Similarly, the patient 1000 can peel off the second portion 3016 by grasping the second tab 3106T and pulling in the relevant direction.

[0207] The tabs 3104T, 3105T, and 3106T allow the corresponding removable layers 3104, 3105, and 3106 to be peeled off after the patient interface 3000 has been properly positioned against the patient's face. The ability to position the patient interface 3000 against the face without adhesive attachment (i.e., when the removable layers are in place) allows the patient to try different positions of the patient interface 3000 before it is adhered. This enables the patient to identify a comfortable and effective position for securing the seal-forming structure 3100 to the patient's face. This is particularly important when the shape of the seal-forming structure 3100 is configured to match / resemble a specific area of ​​the patient's face to which the seal-forming structure 3100 is adhered.

[0208] In the first step, the patient interface 3000, having removable layers 3104, 3105, and 3106, is placed against the patient's face until a suitable position is identified. In the second step, the patient 1000 may slide their fingers under the tabs 3105T or 3106T and / or slightly move the patient interface 3000 forward to provide a gap for the patient 1000 to grasp the tabs 3105T or 3106T. In the third step, the tabs 3105T or 3106T are peeled off to expose the underlying adhesive surface 3102. In the fourth step, the seal-forming structure 3100 is secured to the patient's face by pressing the adhesive surface against the patient's face.

[0209] In one configuration, the tabs 3105T or 3106T can be configured to move away from the patient's facial features when the patient interface 3000 is in the intended position. For example, if the patient interface 3000 is configured to attach to or around the nasal region, the tabs 3105T or 3106T can be positioned away from the nose so that the patient can grasp the tabs 3105T or 3106T without being obstructed by the nose.

[0210] Alternatively, when the patient interface is in the intended position, the flaps 3105T or 3106T can be configured to rest against soft tissue that can deform when a finger slides beneath the flaps 3105T or 3106T for grasping. For example, if the patient interface 3000 is configured to attach to or around the mouth region, the flaps 3105T or 3106T can be positioned against the cheek that can slightly deform to accommodate the patient's fingers when the flaps 3105T or 3106T are grasped.

[0211] 5.3.2 Inflation Chamber

[0212] 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 very close to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 can 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.

[0213] 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.

[0214] In some forms of this technology, the air chamber 3200 is constructed of a transparent material (e.g., transparent polycarbonate). Using a transparent material reduces the prominence 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.

[0215] In some forms of this technology, the air chamber 3200 is constructed of a translucent material. Using a translucent material can reduce the protrusion of the patient interface and help improve adherence to the therapy.

[0216] 5.3.3 Positioning and Stabilizing Structure

[0217] The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by the positioning and stabilizing structure 3300.

[0218] In one configuration, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the positive pressure effect in the inflation chamber 3200 to lift the face away.

[0219] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the effects of gravity on the patient interface 3000.

[0220] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0221] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with a patient wearing it while sleeping. In one example, the positioning and stabilization structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of a device, such as a patient interface 3000. In one example, the positioning and stabilization structure 3300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0222] In one form of this technology, the positioning and stabilizing structure is provided in the form of a headgear, which may include, for example, a collection of one or more straps, support bars, ties, and / or reinforcements, configured to position and hold the patient interface in place on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, elastic materials, such as laminated composites of foam and fabric.

[0223] In other forms of this technology, the positioning and stabilizing structure can be provided by an adhesive sealing forming structure as described herein. In other words, the adhesive can be configured to maintain the sealing forming structure 3100 of the patient interface 3000 in a sealed position during use.

[0224] 5.3.4 Decoupling Structure

[0225] In one form, the patient interface 3000 includes at least one decoupling structure, such as a spindle or a ball-and-socket joint.

[0226] 5.3.5 Connection Port

[0227] Connection port 3600 allows connection to air circuit 4170.

[0228] 5.3.6 Forehead Support

[0229] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0230] 5.3.7 Anti-asphyxiation valve

[0231] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0232] Port 5.3.8

[0233] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In another embodiment, this allows direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0234] 5.4RPT device

[0235] An RPT device 4000 according to one aspect of the present technology includes mechanical components, pneumatic components, and / or electrical components, and is configured to perform one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0236] 5.5 Air Circuit

[0237] According to one aspect of the technology, 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.

[0238] 5.6 Vent

[0239] 5.6.1 Overview of Ventilation Ports

[0240] 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).

[0241] In some configurations, the airway 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 airway 3400 is configured such that the airflow rate is sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining therapeutic pressure within the inflation chamber during use.

[0242] One form of the vent 3400 according to the present technology includes a plurality of holes, such as about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0243] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a decoupling structure, such as a rotating shaft.

[0244] In some forms, the airway is located in a part of the respiratory system other than the patient interface, such as the air circuit, between the air circuit and the patient interface, or between the positioning and stabilizing structures, as described below.

[0245] The following describes in more detail certain forms of vents according to this technology.

[0246] Exhausting gas from the respiratory therapy system may cause noise from the airflow through the ventilator 3400, which may disturb the patient 1000 and / or bed partner 1100.

[0247] The level and quality of noise generated by gas expulsion during inhalation may differ from those during exhalation. Noise is typically higher during exhalation because the exhaled air flows in the opposite direction to the air received from the RPT device 4000 and obstructs the air received from the RPT device 4000, creating turbulence and thus noise. The cyclical nature of the noise may be particularly undesirable.

[0248] Furthermore, the force of the airflow leaving the vent may disturb or make uncomfortable the patient 1000 and / or bed partner 1100. Airflow leaving the vent and directly entering the ambient air can also cause flow separation, especially at high speeds. Flow separation leads to increased turbulence in the airflow and thus generates noise. The faster the airflow leaving the vent, the greater the noise associated with the vent 3400. Therefore, slowing the airflow in the vent can reduce the noise associated with the vent 3400.

[0249] In some forms of this technology, the vent 3400 may be provided in the form of a ventilation structure 6000, which is provided to or included as part of a respiratory system. The vent 3400 may be configured to reduce noise generated by exhaust gases and / or reduce the velocity of airflow as it leaves the vent.

[0250] In some forms, the venting structure 6000 can be formed of a material with relatively high stiffness or a high Young's modulus (such as 1 GPa or higher, or 2 GPa or higher). For example, when using a plastic material (such as polycarbonate), the connecting shell can be constructed of a material with a Young's modulus of about 2.4 GPa. The venting structure can be formed entirely of plastic material, for example as an injection-molded part, but in other examples, the venting structure can be formed of a combination of different materials.

[0251] In some forms, the ventilation structure is rigid. For example, the ventilation structure can be constructed of a high-stiffness material, and its shape results in one or more rigid components, i.e., components that do not deform significantly during normal use.

[0252] In some configurations, the ventilation structure 6000 may have the advantage of omitting any diffuser material, as is present in some existing ventilation ports, to reduce airflow jetting. Diffuser material is an additional component of the patient interface, thus increasing the cost and complexity of manufacturing, assembly, and use, and may require periodic cleaning and / or replacement.

[0253] In some forms of this technology, in addition to including a ventilator 3400 for expelling exhaled air as part of the patient interface 3000, the respiratory system may also include an additional ventilation structure 6000. The additional ventilation structure 6000 can be used to reduce the flow rate of air delivered from the RPT device 4000 to the patient 1000. The additional ventilation structure 6000 may be in the form of a connecting member 7000 or included as part of the connecting member 7000, as described below, and may be positioned in a straight line with the air circuit 4170.

[0254] exist Figures 7A to 7F In the illustrated technical form, the ventilation structure can provide a significant reduction in the noise of the airflow through the vent and the force of the airflow leaving the vent under the following conditions: the airflow leaving the vent is between approximately 11 and 12 L / min; the mask pressure is 10 cm H2O; and the Reynolds number is approximately 1000. When designed for different conditions, the design of the ventilation structure, and particularly various aspects of its geometry, can be varied. The airflow leaving the vent is determined to be approximately one-third of the total airflow released from the respiratory system into the ambient air at approximately 36 L / min. This value is determined to balance maintaining a relatively low airflow through the vent to avoid significant noise with the requirement of air expelled from the mask to prevent CO2 buildup in the mask and patient rebreathing.

[0255] 5.6.2 Location of the ventilation structure

[0256] 5.6.2.1 Connecting Components

[0257] In some forms of this technology, the ventilation structure 6000 may be formed as part of the connecting member 7000. For example, the connecting member 7000 may be configured to fluidly connect the air circuit 4170 to the patient interface 3000, thereby allowing a pressurized breathable gas flow to be delivered from the RPT device 4000 to the patient interface 3000. For example, the connecting member 7000 may be a component attached to the connection port 3600 of the patient interface, thereby attaching the air circuit 4170 to the connection port 3600, such as... Figure 9FAs shown. In other examples, such as Figure 9G In the example shown, the connecting member 7000 may be a component located in the fluid passage between the patient interface and the RPT device 4000, and is configured to connect the first air circuit 4170 to the second air circuit 4170, thereby providing a fluid passage between the patient interface 3000 and the RPT device 4000.

[0258] Figures 7A to 7F A first example of a connection member 7000 according to certain forms of the present technology is illustrated. The connection member 7000 is configured to form part of a respiratory therapy system connecting the air circuit 4170 and the patient interface 3000. In some examples of the present technology, the connection member 7000 may be configured to connect directly to the patient interface 3000, such as by attaching to or otherwise engaging with the connection port 3600, as described herein.

[0259] In other examples of this technology, the connection member 7000 may be configured to be indirectly connected to the patient interface, such as by connecting to the patient interface via a first air circuit 4170. Similarly, the connection member 7000 may be configured to be directly connected to the RPT device 4000, such as by engaging with a connection port on the RPT device 4000. Alternatively, the connection member 7000 may be configured to be connected to the RPT device 4000 via a second air circuit 4170.

[0260] In some forms of this technology, the connecting member 7000 may be attached to the air circuit 4170. For example, at least a portion of the connecting member may be permanently or non-removably attached to the air circuit 4170, for example by using a molding process, such as overmolding at least a portion of the connecting member 7000 onto the air circuit. When the air circuit 4170 and the connecting member are non-removably attached, the connecting member may include the air circuit 4170.

[0261] In other examples, the connecting member 7000 may be a separate component of the air circuit 4170 and / or the patient interface 3000, and may be separable from the air circuit 4170 and / or the patient interface 3000. In one example, the end of the air circuit 4170 may be provided or configured with a permanently or non-removably attached mechanical connector having a threaded, snap-fit, or other suitably profiled surface that mates with a complementary surface on the connecting member 7000. This approach simplifies manufacturing because it eliminates the need for a permanent attachment method for the air circuit, such as overmolding.

[0262] In one embodiment, the connection member 7000 may include a connection housing 7100 configured to fluidly connect the air circuit 4170 to the patient interface 3000. The connection housing 7100 may have a substantially hollow cylindrical structure (i.e., a substantially circular or elliptical cross-section when its cross-section passes through a plane substantially perpendicular to the longitudinal axis of the connection housing 7100), or may otherwise be provided as an assembly forming a substantially cylindrical component. The connection housing 7100 provides an air path to deliver air directly or indirectly from the air circuit 4170 to the patient interface 3000. In other embodiments of the art, the connection housing 7100 may have different cross-sectional shapes, such as elliptical, D-shaped, or polygonal.

[0263] In an example of this technology, the connection housing 7100 may include a first end 7110 configured to receive a pressurized gas flow from the RPT device 4000, such as by receiving a pressurized gas flow from the air circuit 4170; and a second end 7120 configured to deliver the pressurized gas flow directly or indirectly to the patient interface 3000.

[0264] The connecting member 7000 may also include a venting structure 6000 configured to allow air in the connecting housing 7100 to exit and enter the ambient air. The following is about... Figures 7A to 7F A more detailed description of this type of ventilation structure 6000.

[0265] In one embodiment of this technology, the connecting housing 7100 includes an outer connecting portion 7130 and an inner connecting portion 7140. The outer connecting portion 7130 is rotatable relative to the inner connecting portion 7140 about a mutual longitudinal axis B. In other words, the outer connecting portion 7130 and the inner connecting portion 7140 together can provide a decoupling structure in the form of a rotating shaft.

[0266] In the example, at least a portion of the inner connection portion 7140 is located within at least a portion of the outer connection portion 7130. For example... Figure 7F As shown, the end stop 7150 can define the position of the inner connecting portion 7140 and the outer connecting portion 7130 relative to each other. The end stop 7150 can be in the form of a flange on one or both of the outer connecting portion 7130 and the inner connecting portion 7140. Other forms of the end stop 7150 can be provided in other forms of the present technology.

[0267] In one embodiment, the outer connection portion 7130 may include a first end 7110, i.e., the outer connection portion 7130 may be configured to connect to the air circuit 4170, and the inner connection portion 7140 may include a second end 7120, i.e., the inner connection portion 7140 may be configured to connect to the patient interface 3000. In other embodiments, the outer connection portion 7130 may include a second end 7120, and the inner connection portion 7140 includes a first end 7110. The connection of the first end 7110 and / or the second end 7120 to the air circuit 4170 and / or the patient interface 3000 or to intermediate components between them (e.g., other air circuits 4170 or catheters of a certain length) may be achieved via a decoupling arrangement including a ball-and-socket or swivel ring arrangement. For example, the inner connection portion 7140 may be configured to be rotatably connected to the outer connection portion 7130 to provide a decoupling arrangement in the form of a swivel connection.

[0268] In some examples, the inner connection portion 7140 can be removably connected to the outer connection portion 7130 via a clip arrangement, a screw and thread arrangement, or a snap-fit ​​arrangement. See, for example, [reference needed]. Figure 7B , Figure 7F , Figure 9C and Figure 9D The inner and outer connecting portions may include at least one complementary retaining feature, such as one or more channels 9006 and protrusions 9008. In the illustrated example, the outer connecting portion 7130 includes an inwardly projecting protrusion 9008 that engages with or is located therein with the channel 9006 on the outer surface of the inner connecting portion 7140 during use.

[0269] In some examples, the outer connection portion 7130 and / or the inner connection portion 7140 may be configured to be connected to corresponding components, such as the patient interface 3000, the air circuit 4170, and / or the RPT device 4000, using a decoupling structure such as a swivel. For example, the first end 7110 and / or the second end 7120 may be provided with a decoupling structure as described herein.

[0270] In other examples of this technology, the first end 7110 and / or the second end 7120 may be nonremovably connected to (or integrally formed with) another component, such as the air circuit 4170 or a portion of the patient interface 3000. For example, the first end 7110 and / or the second end 7120 may be molded to the patient interface 3000 or the air circuit 4170, or otherwise nonremovably attached, such as using adhesives or welding processes.

[0271] In this example of the technology, it may be advantageous for the vent 3400 to be located within the connecting member 7000, such as by forming the vent 3400 as part of the connecting housing 7100, rather than venting directly from the patient interface 3000. For example, in compact patient interfaces 3000, such as those that use adhesive to adhere to the face, including the vent 3400 within the patient interface increases the size and complexity of the patient interface 3000 structure, both of which can increase the volume of the interface 300 and increase manufacturing costs. Conversely, by positioning the vent 3400 within the connecting member 7000, the size and / or complexity of the patient interface 3000 can be reduced. Additionally, positioning the vent 3400 within the connecting member 7000 may help increase the distance between the patient 1000 and the vent 3400, which can help reduce the noise of the venting perceived by the patient, as well as the interference that the vented gas may cause as it flows over the patient's face.

[0272] In examples of this technology, the connecting housing 7100 is constructed of a material with relatively high stiffness or a high Young's modulus (such as a Young's modulus of 1 GPa or higher, or 2 GPa or higher). For example, the connecting housing 7100 may be constructed of a material with a Young's modulus of about 2.4 GPa (such as polycarbonate). For example, the inner connecting portion 7140 and / or the outer connecting portion 7130 may comprise a material with relatively high stiffness, such as polycarbonate.

[0273] In an example of this technology, the connecting housing 7100 has a substantially hollow cylindrical structure, the inner bore of which defines an airflow passage between the patient interface 3000 and the RPT device 4000.

[0274] 5.6.3 Ventilation Structure

[0275] 5.6.3.1 Ventilation housing

[0276] In some forms of this technology, the ventilation structure 6000 includes a ventilation housing 6100. In some examples, when the ventilation housing 6100 is disposed within the connecting member 7000, the ventilation housing may be provided by the connecting housing 7100. The ventilation housing 6100 may include one or more components that collectively define one or more flow paths 6110 for discharging an airflow from the respiratory system. The ventilation housing 6100 may also define a ventilation inlet 6120 and a ventilation outlet 6130, the ventilation inlet 6120 being configured to allow an airflow to be discharged into the flow path 6110, and the ventilation outlet 6130 being configured to allow an airflow to be discharged out of the flow path into ambient air. The flow path 6110 fluidly connects the ventilation inlet 6120 to the ventilation outlet 6130. The length of the flow path 6110 is generally substantially greater than the width or height of the flow path.

[0277] It should be understood that, in this technical form, the flow path 6110 is a space formed within or partially formed within the vent housing 6100 or the connecting housing 7100. Therefore, the shape and configuration of the flow path 6110 are determined by the shape and configuration of the corresponding vent housing 6100 and / or the connecting housing 7100, particularly those portions of the vent housing 6100 that contact the flow path 6110. In this specification, when referring to the shape and / or configuration of the flow path 6110, it should be understood that this shape / configuration is provided by the shape / configuration of the vent housing 6100 or the connecting housing 7100 that defines the flow path 6110.

[0278] In some forms of this technology, the vent housing 6100 includes a plurality of partitions 6115 that form a plurality of flow paths 6110 therebetween. In some examples, such as in Figure 9A In this context, the flow paths 6110 may all have similar forms, such as having substantially the same shape, width, and / or length. In some examples, the flow paths 6110 are substantially parallel. In some examples, the flow paths may be substantially symmetrical about the longitudinal axis of the connecting member. For example, Figures 7A to 7F The connecting member 7000 shown has cylindrical symmetry, and each of the flow paths 6110 is similarly symmetrical about the longitudinal axis of the cylindrical reference frame. For the purposes of the following description, while a single flow path 6110 will be described in detail, it should be understood that this description may also apply to other flow paths 6110 (if any).

[0279] In some forms of this technology, it may be advantageous for the flow path 6110 to include a taper, i.e., wider at a first end adjacent to the inlet and gradually narrowing toward the turning region 6200, which is described in more detail below. In other words, each of the flow paths can taper inward, thereby reducing the cross-sectional area of ​​the flow path between the vent inlet and the vent outlet.

[0280] The taper may make the corresponding parts easier to manufacture; for example, any part made using an injection molding process is easier to remove from the mold. Another potential advantage of providing a tapered flow path 6110 is that airflow resistance may increase along this path, thereby limiting the velocity of the exhaust air and allowing for better control over the speed at which air is exhausted through the venting structure. Another potential advantage of airflow restriction is that by limiting the size of the airflow path and thus reducing the total volume of exhaust air, the overall sound output can be further controlled or reduced.

[0281] In the technical form in which the ventilation structure 6000 forms part of the connecting member 7000, as described above, the separator can be formed as part of the inner connecting portion 7140 and / or the outer connecting portion 7130.

[0282] The vent housing 6100 may include one or more features, such as those described in later sections, that help reduce noise from airflow through the vent structure 6000.

[0283] 5.6.3.1.1 Connecting Components

[0284] In some forms of this technology, the ventilation structure 6000 may be included as part of the connecting member 7000, for example, Figures 7A to 7F As shown. For example, the ventilated structure of the connecting member 7000 can provide a flow path 6110 between the inner connecting portion 7140 and the outer connecting portion 7130.

[0285] In this form, the vent housing 6100 may be formed by, or included as part of, the connecting housing 7100. In some forms, the vent housing 6100 may be formed by, or included as part of, an outer connecting portion 7130 and an inner connecting portion 7140, wherein the outer and inner connecting portions are arranged coaxially with the outer connecting portion 7130 and are generally radially outside the inner connecting portion 7140. That is, these connecting portions can help define the flow path 6110 of the vent 3400. An advantage of the vent housing 6100 including the outer connecting portion 7130 and the inner connecting portion 7140 is that these two connecting portions can be arranged to be rotatable relative to each other, such that components attached to each end (e.g., different portions of the air circuit 4170) can rotate relative to each other about a longitudinal axis.

[0286] In this configuration, the vent inlet 6120 may be positioned closer to the first end 7110 of the connecting member 7000 than the vent outlet, and the vent outlet 6130 may be positioned closer to the second end 7120 of the connecting member 7000 than the vent inlet. In other configurations, the vent inlet 6120 may be positioned closer to the second end 7120 and the vent outlet 6130 may be positioned closer to the first end 7110.

[0287] exist Figures 7A to 7FIn the illustrated configuration, the vent housing 6100 is configured such that each flow path 6110 includes at least a portion oriented substantially parallel to the longitudinal axis B of the connecting member 7000. In the configuration where the connecting member 7000 includes an outer connecting portion 7130 and an inner connecting portion 7140, each flow path 6110 may have a portion arranged substantially parallel to the longitudinal axes of the two pipe portions (i.e., the mutual longitudinal axes B). In some configurations, the flow path 6110 may be entirely formed within the vent housing 6100, for example, entirely within the outer connecting portion 7130, entirely within the inner connecting portion 7140, or between the outer connecting portion 7130 and the inner connecting portion 7140. As will be discussed below, each flow path 6110 may additionally include at least one portion oriented at an angle not parallel to the longitudinal axis of the connecting member 7000.

[0288] Other features of the vent housing 6100 of this technical form will now be described with reference to the features of the vent structure 6000 in certain forms of this technology, wherein the vent housing 6100 is included as part of the connecting member 7000.

[0289] 5.6.3.1.2 Grip section

[0290] In some forms of this technology, such as Figure 9B , Figure 9F and Figure 9G As shown, the ventilation housing or connection housing may include a gripping portion 9012 configured to be engaged by the hand or fingers of a patient (or other user) to facilitate connection and / or disconnection of the inner connection portion 7140 with the outer connection portion 7130.

[0291] For example, the connecting member 7000 can be configured such that it slides apart in the longitudinal axis direction, thereby causing the inner connecting portion and the outer connecting portion to engage or disengage from each other. The gripping portion 9012 can advantageously allow such sliding engagement or disengagement to be performed more easily, including, for example, by a person with limited finger dexterity or strength.

[0292] 5.6.3.2 Exemplary Flow Path Shape

[0293] In some forms of this technology, the vent housing 6100 is configured such that each flow path 6110 includes a curved turning region 6200 in which the flow path 6110 changes direction by at least 90°. The turning region 6200 generally refers to the region of the flow path in which the change of direction occurs. The turning region 6200 is curved, such that the air flowing through this region smoothly changes direction. For example, in some forms, the turning region does not include any abrupt change of angle or direction. This can be mathematically described as the gradient of the wall of the curved turning region being a continuous function. For example, in… Figures 7A to 7F In the middle, the radius of curvature of the turning area 6200 can be between about 1 mm and about 4 mm, for example, the radius of curvature can be between about 1.3 mm and 1.4 mm, such as 1.345 mm.

[0294] The flow path 6110, including the deflection region 6200 that alters the direction of airflow through the vent, offers several advantages. Due to friction between the air and the walls of the flow path, the airflow velocity along the flow path is reduced. Therefore, generally speaking, the longer the flow path, the larger the surface area of ​​the flow path in contact with the airflow, and the greater the reduction in airflow velocity through friction. However, there are limitations to the length of flow paths that can be practically implemented in components within a respiratory therapy system without compromising the compactness and ease of use of the components. Changing the direction of the flow path 6110 allows it to be longer than in other cases without significantly increasing the length of the components including the vent housing 6100.

[0295] The amount of noise generated when air is expelled from the ventilation structure of a respiratory therapy system is related to the velocity of the expelled air. Generally, more noise is generated when air is expelled at a higher velocity. Therefore, reducing the velocity of the expelled air reduces the amount of noise generated by the ventilation opening.

[0296] The ability to increase the length of the flow path 6110 without increasing the length of the ventilation housing 6100 allows for a relatively compact ventilation design while also reducing noise generated by the airway. A compact ventilation design can be particularly advantageous when the ventilation structure 6000 forms part of a rigid component, for example, when the connecting member is rigid. Since the stiffness of a component depends in part on its physical dimensions and material properties, the ability to provide a compact ventilation structure can facilitate allowing for a lighter, less stiff connecting member 7100. A compact ventilation design can also reduce the weight of the airway and thus improve patient comfort, for example, by reducing the force 3000 applied to the patient interface.

[0297] In some forms of this technology, the turning angle in the turning region 6200 can be anywhere between substantially 90° and a turn that changes the direction of the flow path to substantially the opposite direction (such as substantially 180°). In some forms of this technology, the longitudinal cross-section of the flow path 6110 is substantially U-shaped due to the turning region 6200. For example, in some forms, the turning angle can be substantially 180°. Generally, the larger the turning angle, the greater the reduction in airflow velocity and the greater the kinetic energy consumed, resulting in less noise. The appropriate angle of the turning region 6200 can depend on the nature of the airflow through the flow path 6110. For example, if the flow rate or velocity of the air entering the flow path 6110 is low, a smaller angle of directional change is sufficient.

[0298] exist Figures 7A to 7F In the illustrated technical form, the ventilation structure is included as part of the connecting member 7000. In the exemplary illustrated form, each flow path is configured such that air enters the flow path through a ventilation inlet 6120 near a first end 7110 of the connecting member 7000 and flows in a direction parallel to the longitudinal axis B of the connecting member 7000 through a portion of the flow path 6110 upstream of the turning region 6200. Figure 7F In the illustrated technical form, this portion of each flow path 6110 is formed as a hole through the external connection portion 7130.

[0299] In the turning region 6200, there is a change in the direction of the flow path 6110, which causes the air flowing through this flow path to be diverted away from the central axis B of the connecting housing 7100. In some forms, the turning region 6200 is configured to continue to turn the airflow, and as... Figure 7F As shown, the flow path 6110 changes direction by approximately 180° before exhausting air through the ventilation outlet 6130. Therefore, the airflow exiting the ventilation outlet 6130 flows in a direction substantially parallel to the outer surface of the outer connecting portion 7130 and parallel to the longitudinal axis B of the connecting member 7000. In some forms, the deflection region 6200 is configured such that the direction of the air exiting the ventilation outlet 6130 forms an angle greater than 180° with the angle of the air passing through the ventilation inlet 6120, causing the air exiting the ventilation outlet 6130 to flow towards the outer surface of the outer connecting portion 7130. Exhausting the airflow exiting the ventilation structure 6000 in a direction parallel to or slightly towards the outer wall of the connecting member 7000 avoids exhausting air towards the patient 1000 or bed partner 1100 and causing discomfort. Due to the Coanda effect, the airflow leaving the ventilation structure 6000 can also be a small turbulence, which causes the airflow to remain close to the connecting housing 7100 after leaving the vent.

[0300] In some examples of this technology, where a compact connection member 7000 is desired, such as in a patient interface using an adhesive seal, the flow path may further include a guide member 9002, as described herein. Figures 9A to 9I As shown. This document describes the specific details of the flow guide structure; however, in general, the flow guide 9002 is configured to direct the airflow radially or laterally outward, away from the connecting housing 7100. Thus, in some forms of this art, the flow path includes the flow guide 9002 at or near the vent outlet 6130, for example, the flow guide may be positioned upstream or downstream of the vent outlet along the flow path, such as adjacent to the opening of the vent outlet 6130.

[0301] In some examples, the air guide is configured to guide airflow radially outward of the connecting housing 7100 (e.g., where the connecting member 7000 is typically cylindrical). In other examples, the air guide is configured to guide airflow laterally outward of the connecting housing 7100 (e.g., where the connecting member 7000 is of another shape, such as non-cylindrical). It should be understood that both radially outward and laterally outward refer to directions with at least one component perpendicular to the longitudinal axis of the connecting housing 7100. In some examples, the guided airflow may be directed at an angle substantially 90 degrees to the longitudinal axis of the connecting housing 7100. In other examples of the art, the air guide may be configured to guide airflow at an angle of 5 to 85 degrees relative to the longitudinal axis of the connecting housing 7100. For example, the air guide 9002 may be configured to guide airflow outward without necessarily being directly perpendicular to the longitudinal axis of the connecting housing. For example, the air guide may be configured to guide airflow at an angle of approximately 45 degrees. In other words, the direction of air discharge may have one component perpendicular to the longitudinal axis of the connecting member 7000, and another component parallel to the longitudinal axis of the connecting member 7000.

[0302] Therefore, the guide element 9002 can direct airflow away from the surface of the connecting member 7100, rather than causing airflow to flow along the surface of the connecting member according to the Coanda effect. This may be advantageous in technical examples where the air circuit 4170 is at least partially attached to the outer surface of the outer connecting portion 7130. For example, Figure 9H An example of the present technology is shown, wherein a bladder 9004 is disposed around the outer surface of the outer connection portion 7130. In this example, the guide 9002 is configured to guide the airflow outward, avoiding the bladder 9004, rather than allowing the airflow to directly impact the end of the bladder 9004, which would otherwise result in noise and / or turbulent airflow.

[0303] exist Figure 7FIn the illustrated embodiment, a portion of each flow path 6110 downstream of the turning region 6200 is formed between the outer surface of the outer connecting portion 7130 and the inner surface of the flange 7145, which is included as part of the inner connecting portion 7140. Although included as part of the inner connecting portion 7140, the flange 7145 extends radially outside the outer connecting portion 7130 from the perspective of the cylindrical geometry of the connecting member 7000. In the illustrated embodiment, the flange 7145 extends radially outward from the body of the inner connecting portion 7140, near the second end 7120 of the connecting housing 7100, and curves downward toward the first end 7110 of the connecting housing 7100, such that the distal end of the flange 7145 (and most of the flange body) is radially positioned outside the outer connecting portion 7130. This configuration means that the inner path surface 6300 on the inside of the curved flow path 6110 is the surface of the outer connecting portion 7130, and the outer path surface 6400 on the outside of the curved flow path 6110 is the surface of the inner connecting portion 7140.

[0304] 5.6.3.2.1 Cross-sectional shape of the turning area

[0305] In a technical embodiment where the vent housing includes a curved turning region 6200, the vent housing 6100 includes an inner path surface 6300 on the inner side of the curved flow path 6110 and an outer path surface 6400 on the outer side of the curved flow path 6110. In some embodiments of this technology, the inner path surface 6300 in the turning region 6200 has a cross-sectional shape in the form of an arc or curve. For example, the radius of curvature of the turning region can be between about 1 mm and about 4 mm, such as between about 1.3 mm and 1.4 mm, like 1.345 mm.

[0306] In some forms, only a portion of the inner path surface 6300 in the steering region 6200 may have this type of cross-sectional shape, i.e., a portion of the inner path surface 6300 in the steering region 6200 may also take another form, such as a curved segment of another shape. For example, the steering region may have a complex curvature comprising multiple regions, each with a different radius of curvature.

[0307] For example, in Figure 7F In the illustrated technical form, the portion 6210 of the turning region has a substantially continuous curvature, such as a cross-sectional shape in the form of an arc.

[0308] The use of this essentially continuous curvature helps prevent the airflow through the turning region 6200 from separating or detaching from the inner surface 6400 of the flow path 6110. Such flow separation / detachment can increase turbulence in the airflow through the flow path, which can result in additional noise generated by the vent during use.

[0309] In a relatively compact example of this technique, such as Figures 9A to 9I The ventilator structure 6000 shown has a radius of curvature in the turning region that can be between approximately 1 mm and approximately 1.5 mm, for example, a radius of curvature of approximately 1.35 mm. Using a smaller radius of curvature may be advantageous for providing a more compact ventilator structure. In other examples, a compact radius of curvature can help increase the additional resistance to airflow, thereby allowing for more precise control of the rate of air exhausted through the ventilator structure 6000 at a given air pressure within the air circuit 4170.

[0310] 5.6.3.2.2 Cross-sectional shape of the ventilation structure

[0311] 5.6.3.2.2.1 Aerodynamics

[0312] In some technical forms of the ventilator housing including the curved turning region 6200, the inner path surface 6300 of the ventilator housing 6100 may have an aerodynamic cross-sectional shape or be configured to reduce noise and / or turbulence of the air flowing therein. In some forms, the cross-sectional shape of the inner path surface 6300 of the ventilator housing 6100 may resemble a portion of an airfoil. An airfoil or wing surface is a cross-sectional shape with a curved surface, commonly used in the wings, flaps, and tails of aircraft to generate lift as it moves through a fluid. A typical characteristic of an airfoil is that air flows smoothly across its surface without generating turbulence or air separation. By configuring the inner path surface 6300 to have a cross-sectional shape resembling an airfoil, this characteristic can have beneficial effects on the ventilation structure in a respiratory therapy system. For example, this airfoil shape (specifically, the relatively high length-to-drag ratio of such a shape compared to other shapes) produces a low level of air separation as air flows through the surface or wall forming the flow path 6110. This reduces the turbulent flow generated in the airflow and reduces the noise generated by the airflow through the flow path 6110.

[0313] It should be understood that there are many different cross-sectional shapes that can be considered as wings. In some forms, the cross-sectional shape of the inner path surface 6300 may not have the exact shape of any particular wing, but may have a wing-like curved shape that provides the advantage of generating low-level turbulence, as described above. The shape of the inner path surface 6300 can be modified from some wing shapes, for example, having a shape that is easier to process and manufacture.

[0314] Furthermore, the wing shape forms a closed loop, meaning that a surface on one side of the wing intersects with a surface on the other side at the leading and trailing edges. In this embodiment, the inner path surface 6300 does not form such a closed loop. The inner path surface 6300 may include points equivalent to the wing's leading edge, which form a portion of the flexural turning region 6200. In some embodiments, the inner path surface 6300 does not include points equivalent to the wing's trailing edge. However, the shape of a portion of the wing-like inner path surface 6300 will be described with reference to wing terminology, as if a full wing profile were present.

[0315] By adjusting the cross-sectional shape of the ventilation structure 6000, for example by adjusting the airfoil shape, the point along the flow path 6110 where the airflow transitions from turbulent to laminar flow can be altered. In some configurations, it is desirable to configure the cross-sectional shape such that this transition point is as far away as possible from the ventilation outlet 6130. This helps to reduce the amount of noise generated within the flow path 6110 that propagates to the ventilation outlet 6130, and is therefore particularly audible. With this in mind, experiments with different cross-sectional shapes can be used to identify a suitable cross-sectional shape.

[0316] exist Figure 7F In the illustrated embodiment, the cross-sectional shape of the inner path surface 6300 includes a longitudinally flat region 6310 upstream of the turning region 6200. Downstream of the turning region 6200, the inner path surface 6300 includes a curved region 6320 having a smooth curvature without indentations. Figure 7F As shown, the curved region 6320 continues after the vent outlet 6130, but does not continue indefinitely to intersect with the longitudinally flat region 6310 to form a trailing edge like a typical wing shape. Therefore, the inner path surface 6300 does not form the entire wing shape, but rather a part of it.

[0317] like Figure 7F As shown, if the wing-shaped portion of the surface extends to form a closed loop, the wing-shaped portion of the inner path surface 6300 defines a chord C, i.e., the straight-line distance between the trailing and leading edges of the wing-shaped portion. The chord can have a chord length of at least 50 mm, for example, 54 mm. For the reasons discussed herein, a small chord length may be desired to provide a compact ventilation design. In some forms of this technology, an alternative way to describe the chord length is by a length defined by a straight-line distance, which, if the curved region 6320 extends along its trajectory to intersect with a straight line, begins at a first point 6330 on the inner path surface 6300 furthest from the ventilation inlet 6120 and extends to a second point 6340 furthest from the first point 6330. In technical forms where the ventilation structure 6000 is in the form of a connecting member 7000, such as... Figure 7FAs shown, the chord length can be substantially parallel to the longitudinal axis B of the tube section.

[0318] According to this technology, the wing-like shape of the inner path surface 6300 has a maximum thickness region 6350. This region is... Figure 7F The illustrated technical form is shown as being located along the chord C at a distance D from the leading edge of the wing. In some forms of this technology, the distance D is between 25% and 40% of the chord length. For example, in technical forms with a chord length of approximately 50 to 54 mm, the distance D along the chord to the maximum thickness region 6350 is in the range of 12.5 mm to 22 mm, and in some forms of this technology, this distance is 13.5 mm. It has been found that this effectively keeps the turbulence generated by the flow path at a low level and achieves a satisfactory balance between diffusivity and noise.

[0319] An alternative description of the region with the maximum thickness 6350 is the region on the inner path surface 6300, where the vertical distance between the longitudinally flat region 6310 and the curved region 6320 is the greatest.

[0320] like Figure 7F As shown, in some forms of this technology, the vent outlet 6130 is located downstream of the maximum thickness region 6350. Therefore, in these forms, the outer path surface 6400 covers the inner path surface 6300 to at least the maximum thickness region 6350. It has been found that this arrangement is effective in preventing flow separation when the flow leaves the flow path 6110, which can lead to turbulence and increase noise levels. In some forms of this technology, flow separation can occur at a point along the flow path 6110 adjacent to and downstream of the maximum thickness region 6350. The vent outlet 6130 can be located at a distance I passing through the point where flow separation occurs. Distance I can be a length between one and two times the width of the maximum thickness region 6350. In some forms of this technology, distance I can be in the range of 6 mm to 12 mm. Therefore, in these forms, the outer path surface 6400 covers the inner path surface 6300 at a distance I passing through the maximum thickness region 6350.

[0321] It should be understood that in the compact ventilation structure, or in technical examples where a bladder is disposed around the outer surface of the outer connecting portion 7130, at least a portion of the bladder may be configured to provide the wing structure described herein. In other examples, the ventilation structure may include a guide 9002 configured to first guide the exhaust airflow outward around the bladder, and the bladder may be configured to provide the wing structure.

[0322] 5.6.3.2.2.2 Alternative Ventilation Structure

[0323] In some examples of this technology, such as Figures 9A to 9I For example, alternative forms of connecting members may be beneficial, where the turning radius is reduced and / or the airfoil structure is removed. This can advantageously result in smaller, lower profile structures, better suited for use with adhesive seals as described herein.

[0324] In this example, the venting structure 6000 is configured to form one or more channels between the inner connecting portion 7140 and the outer connecting portion 7130. For example, the outer connecting portion 7140 includes a series of flow paths 6110 formed by a separator 6115 that extends radially around the inner circumference of the outer connecting portion 7130.

[0325] In a preferred embodiment of this technology, four to eight flow paths 6110 may be desired, such as six flow paths. Each of the flow paths may preferably be evenly spaced around the inner circumference of the outer connection portion 7130 and may include a taper as described herein.

[0326] Each of the flow paths can begin at the vent 6120 and travel along the longitudinal length of the inner connecting portion 7130. At one end of the outer connecting portion 7130, away from the vent 6120, the flow path can pass through the turning region 6200 as described herein, and the air flowing through the flow path can now be guided by the outer surface of the inner connecting portion 7130.

[0327] In the illustrated example, a guide element 9002 is positioned at or near the vent outlet 6130 to direct airflow outward from the vent structure, such as radially or laterally, away from the connecting member 7000. In this way, the airflow is directed above or around any structure attached to or around the outer surface of the inner connecting portion 7130, such as... Figures 9F to 9I The bladder 9004 is shown. This reduces any turbulence or disturbance that would otherwise be caused by the exhaust air contacting the bladder 9004.

[0328] 5.6.3.2.3 Width of the flow path

[0329] In some forms of this technology, the width E of the flow path 6110 at the turning region 6200 and in the region downstream of the turning region 6200 is large enough to prevent water droplets in the airflow from clogging the flow path 6110, while being small enough to regulate the flow rate. The width E is illustrated by way of example. Figure 7FThe technical form shown is labeled. The region downstream of the turning region is also described as the aforementioned curved region 6320. The region downstream of the turning region 6200, having the stated width, can be the region between the turning region 6200 and a point on a flow path aligned with the maximum thickness region 6350 of the airfoil shape. In some forms of this technology, the width of the flow path 6110 can be in the range of 0.75 mm to 1.5 mm. It has been found that a flow path 6110 width of at least 0.75 mm prevents water droplets in the airflow from clogging the flow path 6110. The flow rate can be adjusted using a maximum width of 1.5 mm for the flow path 6110. In some forms, the width of the flow path 6110 can be at least 0.85 mm, as it has been experimentally found that this width represents a particularly good balance between the competing considerations of the width of the flow path 6110 explained above.

[0330] In some forms of this technology, the width E of the flow path 6110 at the turning region 6200 can be the minimum width of the flow path 6110 along its length. Therefore, the width E of the flow path 6110 at the turning region 6200 can be described as the minimum distance of the gap between the inner path surface 6300 and the outer path surface 6400.

[0331] In some examples, the vent inlet 6120 may taper to a narrower flow path 6110 within the turning region 6200, for example, tapering to a width of approximately 0.85 mm. The smooth inner wall of the vent housing 6100 promotes low-turbulence flow through the flow path to maintain a low noise level. In this configuration, each flow path 6110 downstream of the turning region 6200 bends around the tapered vent inlet 6120, allowing air to exit from the vent outlet 6130 in a direction substantially opposite to the direction in which air flows into the vent inlet 6120.

[0332] 5.6.3.2.4 Opening angle at the vent outlet

[0333] 5.6.3.2.4.1 Aerodynamic perspective

[0334] In some forms of this technology, the inner path surface 6300 of the vent housing 6100 at the vent outlet 6130 and the outer path surface 6400 of the vent housing 6100 at the vent outlet 6130 define an opening angle. In these forms, the opening angle is the angle between these surfaces at the vent outlet 6130 when the flow path 6110 is viewed in cross-section along its length. Figure 7FIn the illustrated technical forms, the opening angle is denoted as angle F. In some forms, the opening angle is small enough to help reduce air detachment and turbulence leaving the vent outlet 6130, and thus reduce noise generation to a desired level. In some forms, the opening angle is substantially 10° or less. In some forms, such as the one illustrated, the opening angle is substantially 7° or less. It has been found that an opening angle of 7° or less helps reduce air detachment and turbulence leaving the vent outlet 6130, and thus reduces noise generation.

[0335] exist Figure 7F In the illustrated embodiment, if the outer path surface 6400 is oriented substantially parallel to the longitudinal axis B of the connecting housing 7100, the small opening angle between the inner path surface 6300 and the outer path surface 6400 at the ventilation outlet 6130 helps direct airflow leaving the ventilation outlet 6130 toward the inner path surface 6300. As previously explained, this helps reduce patient disturbance by maintaining airflow close to the air circuit 4170.

[0336] 5.6.3.2.4.2 Flow guide

[0337] exist Figures 9A to 9I In the example, the ventilation structure 6000 is provided with a guide 9002, which is configured to guide the airflow radially or laterally outward from the body of the outer connection portion 7130.

[0338] In the illustrated example, the airflow guide 9002 includes a curved airflow guide surface, such as a gently sloping surface 9010, configured to guide the exhaust air outward from the body of the outer connection portion 7130. For example, the curved airflow guide surface may have a continuous curvature, and in some examples of this art, the curved airflow guide surface may have a radius of curvature between about 1 mm and about 1.5 mm, such as about 1.35 mm. Using a curved surface can advantageously reduce turbulence in the exhaust air, thereby reducing noise and / or disturbance to the patient 1000 or bed companion 1100.

[0339] In some examples of this technology, the farthest end of the guide member extending radially outward from the longitudinal axis of the connecting member may be recessed relative to another surface of the connecting member (such as the outer surface of the inner connecting portion 7140). In other words, the inner connecting portion 7140 (such as the flange 7145) may be configured to extend radially outward from the longitudinal axis of the connecting member further than the guide member 9002. For example, since the connecting member 7000 is on bedding or clothing used by the patient, this may advantageously help prevent obstruction or blockage of the ventilation outlet.

[0340] In this example of the technology, the guide extends in a continuous annular shape around the outer surface of the outer connection portion 7130, such as... Figure 9A As shown. In other examples, multiple discrete flow guides 9002 can be provided around the circumference of the connecting member, their positions corresponding to the positions of each flow path 6110 between the outer connecting portion 7130 and the inner connecting portion 7140. For example, if multiple flow paths can be formed in the outer connecting portion 7130, a corresponding number of flow guides can be provided on the inner surface of the outer connecting portion 7130.

[0341] 5.6.3.3 Ventilation shell parameters and flow conditions

[0342] As already described, the ventilation housing 6100 may include one or more features that contribute to reducing noise from the airflow through the ventilation structure 6000. Various parameters relating to these features are mentioned by way of example. Features of the ventilation housing 6100 and parameters applied to these features can be selected to achieve a desired level of noise reduction for the types of flow conditions the device may encounter. Flow conditions can encompass, for example, the flow rate of air flowing through a respiratory therapy system (and therefore the ventilation structure 6000).

[0343] In other forms of this technology, including those operating under different flow conditions, one or more characteristics and / or parameters of the ventilation structure 6000 can be modified to provide the ventilation structure to achieve desired results, such as achieving a desired noise level while achieving a desired ventilation flow rate.

[0344] 5.6.3.4 Noise Attenuation Structure

[0345] In some forms of this technology, for example, Figures 7A to 7F As shown, the venting structure 6000 is included as part of the connecting member 7000 as described above. As described above, the connecting member may include a vent housing 6100. The vent housing 6100 may include an outer connecting portion 7130 and an inner connecting portion 7140 as previously described. In some forms, a portion of each of the flow paths 6110 may be formed by a portion of the gap 7220 between the outer connecting portion 7130 and the inner connecting portion 7140. However, in some forms, the airflow through this gap 7220 may be considered undesirable because it may be difficult to control the tolerances of the gap 7220 between the pipe portions to produce a flow path with the desired form. Therefore, in other forms, for example... Figures 7A to 7F As shown, the outer connection portion 7130 may define only a portion of the flow path 6110, such as a portion of the flow path 6110 upstream of the turning region 6200.

[0346] In this configuration, the outer connecting portion 7130 extends further at the first end 7110 of the connecting housing 7100 than the inner connecting portion 7140 at the same end. An air inlet 6120 is formed in the inner wall of a portion of the outer connecting portion 7130, which is flush with or extends further than the end of the inner connecting portion 7140, such that the air inlet 6120 is exposed within the connecting housing 7100 and allows airflow from within the inner connecting portion 7140 into the flow path 6110.

[0347] exist Figures 7A to 7F In the illustrated technical form, the portion of the flow path 6110 defined only by the outer connecting portion 7130 is the first flow path portion, and is formed in part by the longitudinally flat region 6310 of the inner path surface 6300 upstream of the turning region 6200 as described above. Therefore, the first flow path portion can be substantially parallel to the longitudinal axis B of the connecting member 7000.

[0348] Each flow path 6110 may further include a second flow path portion defined between the inner connection portion 7140 and the outer connection portion 7130. The second flow path portion is downstream of the first flow path portion, such that the second flow path portion receives airflow from the first flow path portion and delivers the airflow to the vent outlet 6130. Figure 7B Openings at the ends of the first flow path portion are shown, allowing the discharged gas to enter the second flow path portion. These openings may be formed in the end region of the inner connection portion 7140 near the second end 7120 of the connecting member. The second flow path portion may include a turning region 6200 and a portion of the flow path 6110 downstream of the turning region 6200, such as the curved region 6320 described above.

[0349] The gas to be discharged is expected to flow along the first flow path portion, along the second flow path portion, through the vent inlet 6120, and then out of the vent inlet 6130. However, a gap 7220 may exist between the outer connecting portion 7130 and the inner connecting portion 7140 (so that the outer connecting portion 7130 can rotate relative to the inner connecting portion 7140, as explained above), and the gap 7220 may be fluidly connected to the flow path 6110. Therefore, the second flow path portion may also receive air from the gap 7220 between the outer connecting portion 7130 and the inner connecting portion 7140.

[0350] The ventilation structure 6000 may also include a noise attenuation structure 7200 for reducing noise generated by the airflow through the gap 7220 between the outer connecting portion 7130 and the inner connecting portion 7140.

[0351] In one form, for example in Figure 7F In the illustrated technical embodiment, the noise attenuation structure 7200 includes portions of an inner connecting portion 7140 and / or an outer connecting portion 7130, which are configured to form a sound attenuation chamber 7210 in a gap 7220 between the inner connecting portion 7140 and the outer connecting portion 7130. The sound attenuation chamber 7210 may be a region of the gap 7220 having a larger cross-sectional area than adjacent regions of the gap 7220. The sound attenuation chamber 7210 is arranged to reflect sound waves during use and attenuate the sound of airflow passing through the gap 7220. Figures 7A to 7F In the illustrated embodiment, multiple sound attenuation chambers 7210 are located at different positions on the circumference of the gap 7220 surrounding the connecting member 7000. The sound attenuation chambers 7210 can possess the characteristics of a broadband silencer.

[0352] In some forms, the noise attenuation structure 7200 includes portions of an inner connecting portion 7140 and / or an outer connecting portion 7130, which are configured to form a stepped region 7230 in the gap 7220 between the inner connecting portion 7140 and the outer connecting portion 7130. The stepped region 7230 may be a region in which the flow path 6110 makes two turns of approximately 90°, one turn in the opposite direction to the other. The stepped region 7230 has the effect of reducing the kinetic energy of the airflow flowing through it, resulting in reduced velocity and less turbulent mixing as the airflow leaves the gap 7220, and thus generating less noise.

[0353] The stepped region 7230 may be located at the sound attenuation chamber 7210, such that the entrance of the sound attenuation chamber 7210 is offset from the exit of the sound attenuation chamber 7210. Alternatively, the stepped region 7230 may be separate from or replace the sound attenuation chamber 7210. Figures 7A to 7F In the illustrated embodiment, the noise attenuation structure 7200 is located near the end stop 7150. The stepped region 7230 may be partially formed by the corner portion of the end stop 7150.

[0354] 5.6.3.5 Curved airflow path

[0355] Figure 8AAnother embodiment of the present technology is illustrated, wherein the venting structure 6000 forms part of the connecting member 7000. The connecting member 7000 is configured to directly or indirectly fluidly connect the air circuit 4170 to the patient interface 3000 and includes several components, including a connecting housing 7100 and the venting structure 6000 for discharging air from the internal volume of the connecting housing 7100. The connecting housing 7100 includes a first end 7110 configured to be directly or indirectly fluidly connected to the air circuit 4170 and a second end 7120 configured to be directly or indirectly connected to the patient interface 3000. The tubing portion also includes an inner connecting portion 7140 and an outer connecting portion 7130. As in some embodiments of the present technology described above, the venting structure includes a venting housing 6100. The venting structure 6000 also includes a plurality of partitions 6115 forming a plurality of flow paths 6110 therebetween.

[0356] The vent housing 6100 includes at least a portion of the connecting housing 7100. Figure 8A In the illustrated embodiment, the flow path 6110 is essentially accommodated along the entire length of the connecting housing 7100, formed between the inner connecting portion 7140 and the outer connecting portion 7130. In other embodiments of the present invention, the ventilation housing 6100 may comprise only a portion of the connecting housing 7100; for example, the flow path may extend only along a portion of the length of the connecting housing 7100. In some embodiments of the present invention, the ventilation housing 6100 may include a central portion of the connecting housing 7100, with end portions of the connecting housing 7100 configured to connect to other components of a respiratory therapy system, such as an air circuit 4170 or a patient interface 3000. The ventilation housing 6100 may include one or more additional components that, together with a portion of the connecting housing 7100, form the ventilation housing 6100.

[0357] exist Figure 8A In the illustrated embodiment, the separator 6115 is formed as part of the inner connecting portion 7140. In other embodiments of the present invention, the separator may be formed on the inner surface of the outer connecting portion 7130. In other embodiments of the present invention, the separator may be formed as part of one or more separation components positioned between the inner connecting portion 7140 and the outer connecting portion 7130 to form a flow path 6110.

[0358] exist Figure 8A In the technical embodiment shown, the separators are evenly distributed around the tube portion 7110.

[0359] As described above, each of the flow paths 6110 includes a ventilation inlet 6120 configured to receive an airflow and a ventilation outlet 6130 configured to allow the airflow to exit into the surrounding ambient air. Figure 8AIn the illustrated configuration, each vent 6120 is formed as a space between an inner connecting portion 7140, an outer connecting portion 7130, and two separators 6115, and each vent is configured to receive air from within the connecting housing 7100. In other embodiments of the present technology, the vent 6120 may be formed entirely by the inner connecting portion 7140, for example, as an opening within the inner connecting portion 7140. Figure 8A In one embodiment, the vent inlet 6120 is located at the first end 7110 of the connecting housing 7100. In other embodiments, the vent inlet 6120 may be formed at the second end 7120 of the connecting housing 7100. In other embodiments, the vent inlet 6120 may be formed in the intermediate region of the connecting housing 7100 between the first and second ends. Figure 8A In the illustrated embodiment, the vent outlet 6130 is located at the end of the flow path 6110 opposite to the vent inlet 6120, and is formed by the outer connecting portion 7130 as described below. In other forms of the present technology, the vent outlet 6130 may be located between the inner connecting portion 7140 and the outer connecting portion 7130 and at the end of the connecting housing 7100 opposite to the vent inlet 6120.

[0360] In this technical form, a portion of the flow path 6110 is curved around the connecting housing 7100, meaning the flow path 6110 follows a curved path across a generally cylindrical surface (e.g., across the outer surface of the inner connecting portion 7140) of the connecting housing 7100. By making a portion of the flow path 6110 curved around the connecting housing 7100, the length of the flow path 6110 is increased compared to a flow path having a straight path in the longitudinal direction along the outer surface of the housing 7100, without significantly increasing the length of the connecting member 7000 to achieve this length. The advantages of increasing the length of the flow path 6110 have been discussed in detail above, but overall it helps to reduce noise generated by exhaust air.

[0361] exist Figure 8AIn this configuration, multiple separators 6115 are configured such that a first portion 6500 of the flow path 6110 bends around the circumference of the inner connecting portion 7140 and also extends longitudinally along the length of the inner connecting portion 7140 (but at an angle to the longitudinal axis of the pipe portion). The first portion 6500 of the flow path 6110 may have two ends 6510 and 6520, with the first end 6510 at the vent inlet 6120 and the second end 6520 located before the turning area, as will be described below. In other forms of this technology, the vent outlet 6130 may be located at the second end 6520, meaning the flow path 6110 may consist only of the first portion 6500 and not include the turning area. Each of the first portions 6500 of the flow path 6110 bends in the same direction and follows a similar shape. This ensures that the flow paths 6110 remain separate and do not overlap with adjacent flow paths 6110. Therefore, the first portion 6500 of the flow path can maintain a substantially constant distance between the separators 6115 along the entire length of the flow path 6110. This can also be described as a flow path 6110 or separator 6115 with a constant width. Figure 8A In this configuration, the first portion 6500 forms a spiral or substantially spiral shape around the connecting housing 7100. When viewed from the first end 7110, the flow path 6110 bends clockwise around the connecting housing 7100. In other forms of this technology, the flow path 6110 may bend in the opposite direction, i.e., bend counterclockwise when viewed from the first end 7110, or form a spiral shape around the connecting housing 7100. Figure 8A The different shapes shown, such as zigzag, serpentine, or other spiral shapes, result in an increase in the length of the flow path 6110 along the connecting housing 7100.

[0362] exist Figure 8A In this embodiment, due to the shape of the flow path 6110 surrounding the connecting housing 7100, the ends 6510, 6520 of the first portion 6500 of each flow path 6110 are circumferentially offset from each other around the connecting housing 7100. In other words, due to the curvature in the flow path 6110, the ends 6510, 6520 are located at different positions around the circumference of the connecting housing 7100. In other forms of this technology, the vent outlet 6130 is located at the second end 6520, which causes the vent inlet 6120 and the vent outlet 6130 to be circumferentially offset around the connecting housing 7100. In some forms of this technology, the first portion 6500 of the flow path 6110 may be curved around the connecting housing 7100, such that the ends 6510, 6520 are circumferentially aligned. In other words, the ends 6510, 6520 are located at the same position around the circumference of the connecting housing 7100.

[0363] In some forms (including) Figure 8A In the form shown, the connecting member 7000 may also include a deflection region 6200 to change the direction of the airflow to a substantially opposite direction and further lengthen the flow path 6110, as described above. The deflection region 6200 may include one or more of the various features discussed above in sections 4.6.3.2 (“Exemplary Flow Path Shape”) and 4.6.2.3.3 (“Width of Flow Path”).

[0364] The turning region 6200 can be located downstream of the first portion 6500 of the flow path 6110. Figure 8A In the illustrated configuration, there is no separator 6115 downstream of the first portion 6500, and this results in the second portion 6600 of the flow path 6110 being connected to form a single flow path for that portion of its length. In other forms of the art, the separator 6115 may continue along the entire length of the flow path 6110 from the vent inlet 6120 to the vent outlet 6130, thereby defining the first and second portions of the flow path.

[0365] exist Figure 8A In the illustrated technical form, the turning region 6200 is entirely formed by the outer connecting portion 7130, which is bent at one end to form a mushroom-shaped portion 7300. Figure 8A In this configuration, the outer connecting portion 7130 is bent into a U-shape, or essentially turned 180°, away from the central longitudinal axis of the connecting housing 7100. The outer connecting portion 7130 is configured to substantially reverse the airflow. In the first flow portion 6500, the airflow generally flows in a direction from the first end 7110 to the second end 7120. After the turning region 6200, the airflow generally flows in a direction from the second end 7120 to the first end 7110. In other forms of this technology, the turning region 6200 can change the direction of the airflow by different angles between 90° and 180°, as discussed above in section 4.6.3.2 (“Exemplary Flow Path Shape”).

[0366] exist Figure 8AIn the outer connecting portion 7130, a first region 7131 has a substantially hollow cylindrical shape. This hollow cylindrical shape is configured to mate around the inner connecting portion 7120, and a first portion 6500 of the flow path 6110 is formed therebetween. A second region 7132 of the outer connecting portion 7130 is formed closer to the second end 7120 of the connecting housing 7100 and includes a curved flange extending outwardly from the first region 7131. The second region 7132 includes a rearwardly extending surface on the outer surface of the first region 7131, and one or more flow paths 6110 are formed between the inner surface of the second region 7132 and the outer surface of the first region 7131. The second region 7132 also has a substantially hollow cylindrical shape. Figure 8A In the first region 7131, the second region 7132 has a smaller radius at the second end 7120 of the connecting housing 7100 compared to the end forming the vent outlet 6130. The second region 7132 forms a surface with a smooth curve between its opposite ends (i.e., from the second end 7120 to the vent outlet 6130). For reasons discussed above, this smooth curve helps direct the airflow leaving the vent towards the outer surface of the first region 7131, which helps reduce noise. In other forms of this technology, the second region 7132 can have different shapes, such as a shape without an increased radius, or a shape with a radius that increases and then decreases again between the second end 7120 and the vent outlet 6130.

[0367] In other forms of this technology, the turning region 6200 may be formed between the inner surface of the flange 7145, which is included as part of the inner connecting portion 7140, and the outer surface of the outer connecting portion 7130, as discussed in section 4.6.3.2 (“Exemplary Flow Path Shape”).

[0368] 5.7 Humidifier

[0369] 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 intended to be delivered to the patient relative to ambient air. Typically, a humidifier 5000 is used to increase the absolute humidity of the airflow (relative to ambient air) and increase the temperature of the airflow before it is delivered to the patient's airway.

[0370] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some forms, such as Figure 5A and Figure 5BAs shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which is adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.

[0371] 5.8 Glossary

[0372] To achieve the purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0373] 5.8.1 General Concepts

[0374] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0375] 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.

[0376] For example, the environment relative to a humidifier humidity This could be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's bedroom. This ambient humidity can differ from the humidity outside the patient's bedroom.

[0377] In another example, environmental stress can be stress that is either close to the body or outside the body.

[0378] 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 by, for example, the RPT device or emitted from the mask or patient interface. Ambient noise may be generated by sources outside the room.

[0379] Automated Positive Airway Pressure (APAP) therapy: In this type of CPAP therapy, the treatment pressure is automatically adjusted between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SBD event.

[0380] Continuous positive airway pressure (CPAP) therapy: In this therapy, the treatment pressure is kept approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet is slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing when no indication of partial upper airway obstruction is detected.

[0381] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, referring to flow rate will refer to a scalar, that is, a quantity that only has magnitude. In other cases, referring to flow rate will refer to a vector, that is, a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. "Flow rate" is sometimes simply abbreviated as "flow" or "airflow".

[0382] In the example of patient breathing, the flow rate may be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Device flow rate Qd is the flow rate of air leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. Ventilation flow rate Qv is the flow rate of air leaving the vent to allow for the clearance of exhaled gas. Leakage flow rate Ql is the flow rate leaking from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received from the patient's respiratory system.

[0383] Flow therapy: Breathing therapy involves delivering a flow of air to the inlet of the airway at a controlled flow rate known as the therapeutic flow rate, which is generally positive throughout the patient’s respiratory cycle.

[0384] Humidifier: The term humidifier will be considered to refer to a humidifying device that is constructed and arranged or configured with a physical structure to provide a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve a patient’s medical respiratory condition.

[0385] Leakage: The term "leakage" will be considered as an unintended flow of air. In one example, a leak might occur due to an incomplete seal between the mask and the patient's face. In another example, a leak might occur in a swivel bend leading to the environment.

[0386] 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.

[0387] Radiated noise (acoustics): In this document, radiated noise refers to noise transmitted to the patient by ambient air. In one form, radiated noise can be quantified according to ISO 3744 by measuring the sound power / sound pressure level of the object under discussion.

[0388] Vent noise (acoustic): Vent noise in this document refers to the noise generated by the airflow through any vent (such as the vent hole of a patient interface).

[0389] Patient: A person, regardless of whether they have a respiratory illness.

[0390] Pressure: Force per unit area. Pressure can be expressed in units, including cmH2O and gf / cm². 2 And hectopascals. 1 cmH2O equals 1 gf / cm³ 2 And it is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m). 2 = 1 millibar to 0.001 atm). In this specification, unless otherwise stated, pressure is given in cmH2O.

[0391] 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 achieved at the current moment through the interface pressure Pm.

[0392] Respiratory pressure therapy (RPT): Applying a therapeutic pressure, normally positive relative to the atmosphere, to the airway inlet.

[0393] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0394] 5.8.1.1 Materials

[0395] Silicone or silicone elastomer: a synthetic rubber. In this specification, reference to silicone refers to liquid silicone (LSR) or molding silicone (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0396] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0397] 5.8.1.2 Mechanical Properties

[0398] Resilience: The ability of a material to absorb energy when it deforms elastically and to release energy when it is unloaded.

[0399] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain silicones and thermoplastic elastomers.

[0400] Hardness: The ability of a material to resist deformation (e.g., described by Young's modulus or an indentation hardness scale measured on a standardized sample size).

[0401] "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0402] "Hard" materials can include polycarbonate, polypropylene, steel or aluminum, and can be resistant to deformation, for example, under finger pressure.

[0403] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. The structure or component can provide different resistance in different directions. The opposite of stiffness is flexibility.

[0404] Flexible structures or components: Structures or components that will change shape (e.g., bend) when made to support their own weight for a relatively short period of time, such as 1 second.

[0405] Rigid structure or component: A structure or component that will not substantially change shape when subjected to the loads typically encountered in use. An example of such use could be, for instance, setting and maintaining a seal between the patient interface and the inlet of the patient's airway at a pressure of approximately 20 to 30 cmH2O.

[0406] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another instance, the structure or component may be flexible in the first direction and rigid in the second direction.

[0407] 5.8.2 Patient Interface

[0408] Anti-asphyxiation valve (AAV): A component or sub-assembly of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0409] Bend: A bend is an example of a structure that directs the axis of an airflow through it by an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. A bend can have a generally circular cross-section. In another form, a bend can have an elliptical or rectangular cross-section. In some forms, the bend can rotate relative to the mating component, for example, approximately 360 degrees. In some forms, the bend can be removed from the mating component, for example, via a snap-fit ​​connection. In some forms, the bend can be assembled onto the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0410] Frame: The frame is generally considered to refer to the mask structure that bears the tensile load between two or more connection points with 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.

[0411] Headgear: A headgear is considered to refer to a form of positioning and stabilizing structure designed for use on the head. For example, a headgear may include an assembly of one or more support bars, straps, and reinforcements configured to position and hold a patient interface in place over the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, elastic materials, such as laminated composites of foam and fabric.

[0412] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0413] 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 volumetric space containing air pressurized therein to above atmospheric pressure. An outer shell may form part of the wall of the mask inflation chamber.

[0414] 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 "sealing" element itself.

[0415] Shell: The term "shell" is generally considered to refer to a curved, relatively thin structure with bending, tensile, and compressive stiffness. For example, the curved structural wall 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.

[0416] 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.

[0417] Support rod: The support rod will be considered as a structural component designed to increase the compressive strength of another component in at least one direction.

[0418] Rotary shaft (noun): A sub-assembly of a component configured to rotate about a common axis, preferably independently, and preferably under low torque. In one form, the rotary shaft may be configured to rotate by an angle of at least 360 degrees. In another form, the rotary shaft may be configured to rotate by an angle of 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, there may be little or no airflow leaking from the rotary shaft.

[0419] Lacing (noun): A structure designed to resist tension.

[0420] Ventilation port (noun): A structure that allows air to flow from inside the mask or tubing into ambient air to effectively clear exhaled gases in a clinical setting. For example, effective clearance in a clinical setting can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute, depending on the mask design and treatment pressure.

[0421] 5.9 Other Notes

[0422] This patent document contains a portion of copyrighted material. The copyright holder does not object to any fax reproduction of the patent document or patent disclosure appearing in the patent office's patent documents or records, but otherwise reserves all copyright rights.

[0423] Unless the context clearly indicates otherwise and where a range of values ​​is provided, it should be understood that every intermediate value between the upper and lower limits of the range (to one-tenth of the lower limit unit), and any other stated or intermediate value within the stated range, is included within this technology. The upper and lower limits of these intermediate ranges (which may be independently included in the intermediate range) are also included within this technology, subject to any specific exclusions within the stated range. Where the stated range includes one or both of these limitations, the range excluding any one or both of those included limitations is also included within this technology.

[0424] 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 the actual technical implementation may allow or require.

[0425] 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.

[0426] When a particular material is determined to be used for constructing a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise specified, any and all components described herein are to be understood as being capable of being manufactured, and therefore can be manufactured together or separately.

[0427] It must be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents, unless the context clearly indicates otherwise.

[0428] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. This document should not be construed as an admission that the present technology is not entitled to any prior disclosure due to a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0429] The terms “comprises” and “comprising” should be interpreted as referring to an element, component, or step in a non-exclusive manner, indicating that the mentioned element, component, or step may be present or used, or in combination with other elements, components, or steps not explicitly mentioned.

[0430] The headings used in the detailed description are for the convenience of the reader only and should not be used to limit the subjects that can be found throughout the invention or the claims. These headings should not be used to interpret the scope or limit of the claims.

[0431] 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 may be performed simultaneously or even concurrently.

[0432] Therefore, it should be understood that various modifications can be made to the exemplary examples and other arrangements can be designed without departing from the spirit and scope of this technology.

Claims

1. A ventilation structure for a respiratory therapy system, the ventilation structure comprising: Ventilation housing, the ventilation housing defining: Flow path for exhausting airflow from the respiratory therapy system; A ventilation inlet configured to allow the airflow into the flow path; as well as A ventilation outlet configured to allow the airflow to leave the flow path and enter the surrounding ambient air; The vent housing is configured such that the flow path includes a bend and turn region in which the flow path changes direction by at least 90°; The ventilation housing includes a flow guide at or near the ventilation outlet, wherein the flow guide is configured to direct the airflow radially or laterally outward from the ventilation housing.

2. The ventilation structure according to claim 1, wherein the flow guide is positioned upstream of the ventilation outlet along the flow path.

3. The ventilation structure according to claim 1, wherein the guide element is positioned downstream of the ventilation outlet.

4. The ventilation structure according to any one of the preceding claims, wherein the flow guide includes a curved flow guide surface.

5. The ventilation structure according to any one of the preceding claims, wherein the curved guide surface has a continuous curvature.

6. The ventilation structure according to any one of the preceding claims, wherein the ventilation structure is disposed in a connecting member configured to provide a connection between a patient interface and a respiratory pressure therapy device.

7. The ventilation structure according to claim 6, wherein the connecting member comprises an inner connecting portion and an outer connecting portion, wherein the ventilation structure is disposed between the inner connecting portion and the outer connecting portion.

8. The ventilation structure according to claim 7, wherein the flow guide is disposed on the outer surface of the outer connecting portion.

9. The ventilation structure according to claim 8, wherein the flow guide extends in a continuous annular shape around the outer surface of the outer connecting portion.

10. The ventilation structure according to any one of claims 7 to 9, wherein the connecting member has a longitudinal axis.

11. The ventilation structure according to claim 10, wherein the inner connecting portion extends radially outward from the longitudinal axis further than the flow guide.

12. The ventilation structure according to claim 10 or 11, wherein the air guide is configured to guide the airflow in a direction having a component perpendicular to the longitudinal axis and a component parallel to the longitudinal axis.

13. The ventilation structure of claim 12, wherein the air guide is configured to guide the airflow at an angle of 5 to 85 degrees relative to the longitudinal axis.

14. The ventilation structure according to any one of the preceding claims, wherein in the turning region, the inner path surface has an arcuate cross-sectional shape.

15. The ventilation structure according to any one of the preceding claims, wherein the flow path changes direction to substantially the opposite direction through the deflection region.

16. The ventilation structure of claim 15, wherein the flow path changes direction by an angle of substantially 180° through the deflection region.

17. The ventilation structure according to any one of the preceding claims, wherein the ventilation housing includes a plurality of partitions forming a plurality of flow paths therebetween, wherein the plurality of flow paths includes the flow path, and other flow paths among the plurality of flow paths are similar to the flow path.

18. A patient interface, the patient interface comprising: An inflation chamber capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflation chamber including an inflation chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for patient breathing. A sealing structure is configured and arranged to form a seal with the area of ​​the patient's face surrounding the patient's airway inlet, the sealing structure having an opening therein such that the airflow under the therapeutic pressure is delivered to at least one inlet of the patient's nostril, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle during use; as well as The ventilation structure according to any one of claims 1 to 17, wherein the ventilation structure allows the patient's exhaled gas to flow continuously from the interior of the inflatable chamber to the environment, and the size and shape of the ventilation structure are designed to maintain the therapeutic pressure in the inflatable chamber during use.

19. The patient interface of claim 18, wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of a pressurized airflow through the inlet port of the inflation chamber, or the patient interface is configured not to cover the patient's mouth.

20. A connecting member configured to fluidly connect an air circuit to a patient interface of a respiratory therapy system, the connecting member comprising: A connecting housing, the connecting housing including a first end configured to be fluidly connected directly or indirectly to the air circuit and a second end configured to be fluidly connected directly or indirectly to the patient interface; as well as The ventilation structure according to any one of claims 1 to 17 is configured to allow air in the connecting housing to leave and enter the ambient air.

21. The connecting member according to claim 20, wherein the connecting housing comprises: External join portion; as well as Inner join portion.

22. The connecting member of claim 21, wherein the outer connecting portion is rotatable relative to the inner connecting portion about a mutual longitudinal axis.

23. The connecting member according to any one of claims 21 or 22, wherein the outer connecting portion includes the first end, and the inner connecting portion includes the second end.

24. A connecting member configured to directly or indirectly fluidly connect an air circuit to a patient interface in a respiratory system, the connecting member comprising: A connection housing configured to fluidly connect the air circuit to the patient interface, the connection housing comprising: It is configured to be directly or indirectly fluidly connected to the first end of the air circuit; The second end of the patient interface is configured to be directly or indirectly fluidly connected to it. outer join portion; and Inner linker; The outer connecting portion is rotatable relative to the inner connecting portion and the outer connecting portion about their respective longitudinal axes. The connecting member further includes: A ventilation structure for discharging air from the inner connecting portion into the surrounding ambient air, the ventilation structure comprising: A vent housing including at least a portion of the external connection portion, wherein the external connection portion defines only a portion of a flow path for discharging airflow, and wherein the vent housing defines: A ventilation inlet configured to allow the airflow to enter the flow path from within the connecting member; and A vent outlet configured to allow the airflow to exit the vent housing and enter the surrounding ambient air. The ventilation outlet includes a guide at or near the ventilation outlet, wherein the guide is configured to direct the airflow radially outward from the ventilation housing.

25. The connecting member of claim 24, wherein the flow guide is positioned upstream of the vent outlet in the flow path.

26. The connecting member of claim 24, wherein the flow guide is positioned downstream of the vent outlet.

27. The connecting member according to any one of claims 24 to 26, wherein the flow guide includes a flow guiding surface.

28. The connecting member according to any one of claims 24 to 27, wherein the flow guiding surface has a continuous curvature.

29. The connecting member according to any one of claims 24 to 28, wherein the venting structure is formed between the inner connecting portion and the outer connecting portion.

30. The connecting member according to any one of claims 24 to 29, wherein the flow guide is disposed on the outer surface of the outer connecting portion.

31. The connecting member according to any one of claims 24 to 30, wherein the flow guide extends in a continuous annular shape around the outer surface of the outer connecting portion.

32. The connecting member according to any one of claims 24 to 31, wherein the inner connecting portion extends radially outward from the longitudinal axis further than the guide member.

33. The connecting member according to any one of claims 24 to 32, wherein the air guide is configured to guide the airflow in a direction having a component perpendicular to the longitudinal axis and a component parallel to the longitudinal axis.

34. The connecting member of claim 33, wherein the air guide is configured to guide the airflow at an angle of 5 to 85 degrees relative to the longitudinal axis.

35. The connecting member according to any one of claims 24 to 34, wherein the flow path is substantially parallel to the mutual longitudinal axes.

36. The connecting member according to any one of claims 24 to 35, wherein the portion of the flow path defined by the outer connecting portion is a first flow path portion, wherein the vent housing further includes a portion of the inner connecting portion, wherein the inner connecting portion and the outer connecting portion define a second flow path portion therebetween, wherein the flow path includes the second flow path portion, and wherein the second flow path portion receives the airflow from the first flow path portion and delivers the airflow to the vent outlet.

37. The connecting member according to any one of claims 24 to 36, wherein the second flow path portion includes a bending and turning region, wherein the flow path changes direction by at least 90° in the bending and turning region.

38. The connecting member of claim 37, wherein the flow path changes direction to substantially the opposite direction through the turning region.

39. The connecting member of claim 38, wherein the flow path changes direction by an angle of substantially 180° through the turning region.

40. The connecting member according to any one of claims 24 to 39, wherein the first end is configured to be directly fluidly connected to a first portion of the air circuit, and the second end is configured to be directly fluidly connected to a second portion of the air circuit.

41. The connecting member according to any one of claims 24 to 40, wherein the outer connecting portion includes the first end, and the inner connecting portion includes the second end.

42. A connecting member configured to directly or indirectly fluidly connect an air circuit to a patient interface of a respiratory therapy system, the connecting member comprising: A connection housing configured to fluidly connect the air circuit to the patient interface, the connection housing comprising: Configured to be directly or indirectly fluidly connected to the first end of the air circuit; and The second end of the patient interface is configured to be directly or indirectly fluidly connected. The connecting member further includes: A venting structure for discharging air from the internal volume of the connecting housing, the venting structure comprising: A ventilated housing, the ventilated housing including at least a portion of the connecting housing; and A plurality of partitions within the vent housing, the plurality of partitions forming a plurality of flow paths therebetween, each of the flow paths comprising: Ventilation inlets configured to receive airflow; and It is configured to allow the airflow to exit the vent that enters the ambient air. Each of the flow paths tapers inward, thereby reducing the cross-sectional area of ​​the flow path between the vent inlet and the vent outlet.

43. The connecting member of claim 42, wherein the vent inlet and the vent outlet are circumferentially offset around the connecting housing.

44. The connecting member according to claim 42 or 43, wherein each of the flow paths forms a spiral shape around the connecting housing.

45. The connecting member according to any one of claims 42 to 44, wherein the vent inlet is located closer to the first end of the connecting housing.

46. ​​The connecting member according to any one of claims 42 to 45, wherein the vent outlet is located closer to the second end of the connecting housing.

47. The connecting member according to any one of claims 42 to 46, wherein the connecting housing comprises: External join portion; as well as Inner join portion.

48. The connecting member of claim 47, wherein the outer connecting portion is rotatable relative to the inner connecting portion about a mutual longitudinal axis.

49. The connecting member according to any one of claims 47 or 48, wherein the vent housing includes at least a portion of the outer connecting portion.

50. The connecting member according to any one of claims 47 to 49, wherein the vent housing includes at least a portion of the inner connecting portion.

51. The connecting member according to any one of claims 47 to 50, wherein the separator is formed on the outer surface of the inner connecting portion.

52. The connecting member according to any one of claims 42 to 51, wherein the first end is configured to be directly fluidly connected to a first portion of the air circuit, and the second end is configured to be directly fluidly connected to a second portion of the air circuit.

53. The connecting member according to any one of claims 42 to 52, wherein the mushroom-shaped portion includes a deflection region configured to change the direction of the airflow to a substantially opposite direction.

54. The connecting member according to claim 53, wherein the airflow changes direction by an angle of substantially 180° through the deflection region.

55. A system for treating respiratory disorders, the system comprising: Patient interface The connecting component includes a ventilated structure. A first air circuit, the first air circuit having a first end attached to the patient interface and a second end attached to the connecting member. A respiratory pressure therapy device (RPT device) configured to generate a positive pressure flow of breathable gas. A second air circuit, the second air circuit having a first end connected to the connecting member and a second end connected to the RPT device. The ventilation structure includes at least one flow path having a bend and turn region in which the flow path changes direction by at least 90°; and a guide member configured to guide the airflow radially or laterally outward from the longitudinal axis of the connecting member.

56. The system of claim 55, wherein the first air circuit is detachably attached to the patient interface and / or connecting member.

57. The system of claim 55 or 56, wherein the second air circuit is detachably attached to the connecting member and / or the RPT device.

58. The system according to any one of claims 55 to 57, wherein the second air circuit comprises a bladder.

59. The system of claim 58, wherein the airflow guide is configured to direct the airflow outward around the bladder.

60. The system according to any one of claims 55 to 59, wherein the ventilation structure includes a ventilation inlet and a ventilation outlet, and wherein the ventilation inlet is circumferentially offset relative to the ventilation outlet around the connecting housing.

61. The system of claim 60, wherein the ventilation inlet is located closer to the second air circuit than the first air circuit.

62. The system according to any one of claims 55 to 61, wherein the connecting member comprises: External join portion; as well as Inner join portion.

63. The system of claim 62, wherein the outer connecting portion is rotatable relative to the inner connecting portion about a mutual longitudinal axis.

64. The system according to any one of claims 62 or 63, wherein the ventilation structure includes at least a portion of the external connection portion.

65. The system according to any one of claims 62 to 64, wherein the venting structure includes at least a portion of the inner connecting portion.

66. The system according to any one of claims 62 to 65, wherein one or more separators are formed on the outer surface of the inner connection portion.

67. The system according to any one of claims 55 to 66, wherein the airflow changes direction by an angle of substantially 180° through the turning region.

68. The system according to any one of claims 55 to 67, wherein the patient interface comprises an adhesive seal.

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