Therapeutic system for respiratory-related conditions and headgear for use therewith

Abstract

The present technology relates to a patient interface for delivering a flow of pressurized air to an entrance of a patient’s airways, the patient interface comprising a mask having a seal-forming structure and one or more positioning and stabilising structures configured to provide a force to maintain the mask in a therapeutically effective position on a patient’s head in use. The mask and the one or more positioning and stabilising structures include connection ports to receive an end of an air circuit. Pressurized air is delivered from the air circuit to the seal-forming structure. In use, a patient connects the air circuit to a selected connection port depending on whether they prefer to arrange the patient interface so that the end of the air circuit is above or below the patient’s ear level point.

Description

[0001] 1. Cross-references to related applications

[0002] This application claims the benefit of Australian Provisional Application No. 2019903366, filed on 10 September 2019; and Australian Provisional Application No. 2019903364, filed on 10 September 2019, each of which is incorporated herein by reference in its entirety. 2 Background Technology 2.1.1 Technical Field

[0005] 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.

[0006] 2.2 Description of related technologies

[0007] 2.2.1 Human Respiratory System and Its Diseases

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

[0009] The airways consist of a series of branching 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 carbon dioxide to move in the opposite direction. The trachea divides into the left and right main bronchi, which eventually branch into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, by John B. West, Lippincott Williams & Wilkins, 2012.

[0010] There are a range of respiratory diseases. Some diseases can be characterized by specific events, such as sleep apnea, hypoventilation, and hyperventilation.

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

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

[0013] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is an impairment of the patient's respiratory control, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and reoxidation of arterial blood. CSR can be harmful due to repetitive hypoxia. In some patients, CSR is associated with recurrent awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

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

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

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

[0017] Chronic obstructive pulmonary disease (COPD) 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.

[0018] 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 diseases can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive diseases: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive diseases: 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.

[0019] Chest wall disorders are a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and 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.

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

[0021] 2.2.2 Treatment

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

[0023] 2.2.2.1 Respiratory pressure therapy

[0024] Respiratory pressure therapy is the application of supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy such as canister ventilators or thoracic brachial tubes).

[0025] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or unsightly, among other things.

[0026] 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 forms such as OHS, COPD, NMD, and chest wall diseases. In some forms, it can improve the comfort and effectiveness of these treatments.

[0027] Noninvasive ventilation (IV) provides ventilatory support for patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0028] 2.2.2.2 Flow Therapy

[0029] Not all respiratory therapies are designed to deliver a prescribed therapeutic pressure. Some respiratory therapies are designed to deliver a prescribed volume of air by delivering an inspiratory flow distribution (potentially superimposed on a positive baseline pressure) over a target duration. In others, 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 substantially constant throughout the respiratory cycle. The 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 removing 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 for secretion management) and the possibility of a moderate increase in airway pressure. As an alternative to constant flow, therapeutic flow can follow a curve that varies with respiratory cycles.

[0030] Another form of mobile therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. Doctors can prescribe a continuous flow of oxygen-enriched gas to the patient's airway at a specific oxygen concentration (from 21% to 100% of the oxygen fraction in ambient air) and at a specific flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0031] 2.2.2.3 Supplementing oxygen

[0032] For some patients, oxygen therapy can be combined with respiratory pressure therapy (RPT) or high-pressure airflow (HFT) by adding supplemental oxygen to the pressurized airflow. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplemental oxygen.

[0033] 2.2.3 Respiratory Therapy System

[0034] 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.

[0035] 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.

[0036] Another type of treatment system is the mandibular repositioning device.

[0037] 2.2.3.1 Patient Interface

[0038] 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 treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cmH2O to the airway. For flow treatments 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.

[0039] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems 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 pressure.

[0040] Certain masks may be clinically disadvantageous for this technique, for example, if they block airflow through the nose and only allow it through the mouth.

[0041] If patients need to insert part of the mask structure into their mouths to create and maintain a seal through their lips, some masks may be uncomfortable or impractical for this technique.

[0042] 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.

[0043] 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 bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jawbone or mandible can move relative to other bones of the skull. The entire head can move during respiratory therapy.

[0044] As a result of these challenges, some masks suffer from one or more protrusions, aesthetically undesirable features, high cost, poor fit, difficulty in use, and discomfort, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized mask can lead to reduced adherence, decreased comfort, and poorer patient outcomes. Masks designed solely for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks used for the administration of anesthetics may be tolerable for their original application; however, such masks can still be undesirably 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 mask is worn during sleep.

[0045] CPAP therapy is highly effective for treating certain respiratory conditions, provided the patient adheres to the treatment. Patients may not adhere to treatment 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.

[0046] While masks designed for other applications (such as navigators) may not be suitable for treating sleep-disordered breathing, masks designed for treating sleep-disordered breathing may be suitable for other applications.

[0047] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0048] 2.2.3.1.1 Sealing Formation Structure

[0049] The patient interface may include a seal-forming structure. Since the seal-forming structure comes into direct contact with the patient's face, its shape and configuration can directly affect the effectiveness and comfort of the patient interface.

[0050] Patient interfaces can be characterized in part by their design intent to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element that surrounds both nostrils during use. This single element may be designed, for example, to cover the supralipal and nasal bridge regions of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both the nostrils and mouth regions during use. These different types of patient interfaces may be known by their manufacturers under various names, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0051] A sealing structure that works in one area of ​​a patient's face may be unsuitable in another, for example, due to the different shapes, structures, variability, and sensitive areas of the patient's face. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0052] Certain seal-forming structures can be designed for mass production, making a design suitable and comfortable and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the patient's facial shape and the seal-forming structure of the mass-produced patient interface, one or both must be modified to form a seal.

[0053] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface during face-to-face engagement. This seal-forming structure may include an air- or fluid-filled gasket, or a molded or formed surface of an elastic sealing element made of an elastomer, such as rubber. With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0054] Another type of seal-forming structure incorporates a sheet-like seal of thin material surrounding the periphery of the mask to provide a self-sealing effect on the patient's face when positive pressure is applied within the mask. Similar to the previous type of seal-forming section, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or buckle during use, causing leakage.

[0055] Another type of sealing structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0056] Another form of seal formation can be achieved using adhesives. Some patients may find it inconvenient to frequently apply and remove adhesives from their face.

[0057] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0058] One form of nasal pillow is found in the Adam circuitry manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0059] ResMed Limited manufactures the following products that combine nose pillows: SWIFT TM Nose pillow cover, SWIFT TM II Nose pillow cover, SWIFT TM LT nose pillow cover, SWIFT TM FX nose pillow and MIRAGE LIBERTY TM Full-face mask. The following patent application assigned to ResMedLimited describes an example of a nose pillow mask: International Patent Application WO2004 / 073,778 (described by ResMedLimited SWIFT) TM Other aspects of the nose pillow), U.S. Patent Application 2009 / 0044808 (describes ResMed Limited SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (describe ResMed Limited MIRAGE LIBERTY) TMOther aspects of the full-face mask); International Patent Application WO 2009 / 052,560 (describes ResMed Limited SWIFT) TM Other aspects of the FX nose pillow).

[0060] Understandably, patients have a wide range of options for patient interfaces and sealing structures. However, switching between these options can be a significant investment for patients, especially since they may be designed to wear specially designed positioning and stabilization structures.

[0061] 2.2.3.1.2 Positioning and Stabilizing Structure

[0062] The sealing structure of the patient interface used in positive pressure therapy is subject to the corresponding force of air pressure, which can disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain a sealing relationship with the appropriate part of the face.

[0063] A widely used technique for positioning a sealing structure on a patient's face is to provide one or more straps and / or stabilizing straps as positioning and stabilizing structures. These structures are often referred to as headgear.

[0064] The headgear may include multiple straps and buckles that engage with the patient interface. Some examples of headgear are characterized by one or more of the following: ill-fitting, bulky, uncomfortable, and inconvenient to use.

[0065] 2.2.3.2 Pressurized air duct

[0066] In one type of treatment system, pressurized airflow is supplied to the patient interface via a conduit or tube in an air circuit fluidly connected to the front of the patient interface, such that when the patient interface is positioned over the patient's face during use, the conduit extends forward from the patient's face out of the patient interface. Typically, the conduit is not connected to the patient interface at any other location, and thus hangs vertically downwards from the interface under gravity. This type of interface is sometimes referred to as a "tube-down" or "elephant trunk" type interface.

[0067] 2.2.3.2.1 Pressurized air duct used for positioning / stabilizing the sealing structure

[0068] An alternative type of treatment system includes a patient interface in which a tube or substantially hollow elongated structure for delivering pressurized air to the patient's airway also serves as part of a structure for positioning and stabilizing a sealing portion of the patient interface to an appropriate part of the patient's face (e.g., a headgear). This means that the headgear forms part of an air circuit. For the purposes of this specification, the terms "tube" and "catheter" should be considered to have the same meaning unless the context clearly indicates otherwise.

[0069] This type of patient interface may be referred to as a combination of a “headband tube” or “catheter headband,” these terms are to be understood as interchangeable for the purposes of this specification unless the context otherwise indicates. Such a patient interface allows a catheter in an air circuit providing pressurized airflow from a respiratory pressure therapy device to be connected to the patient interface at a location other than in front of the patient’s face. An example of such a treatment system is disclosed in U.S. Patent Publication No. 2007 / 0246043, the contents of which are incorporated herein by reference, wherein the catheter is connected to the patient interface via a port positioned on the top of the patient’s head during use. This may be referred to as a “tube-up” configuration.

[0070] The Philips DreamWear™ face mask includes this catheter headgear / headgear cannula. The length of the DreamWear™ headgear cannula is not adjustable. Therefore, three different sizes of DreamWear™ headgear are offered to accommodate patients with different face sizes. Offering more different sizes increases the complexity and cost of manufacturing the headgear and could result in larger packaging. Additionally, the availability of discrete-size face masks may limit the extent to which different sized patients' heads can be accommodated. If forced to choose between discrete sizes with non-adjustable lengths, some patients may have a greater chance of not achieving what they perceive as a comfortable fit.

[0071] Some patients may prefer an interface with a headpiece cannula because this allows for an upward-facing cannula configuration, avoiding a catheter connected to the patient interface in front of the patient's face. This can be considered unsightly and unpleasant. However, other patients may not find a "cannula-down" interface a problem.

[0072] 2.2.3.3 Respiratory Pressure Therapy (RPT) Device

[0073] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned treatments, for example, by operating the device to generate an airflow for delivery to an airway interface. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Therefore, RPT devices can also be used as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0074] Pneumatic generators are known in a variety of applications, such as industrial-scale ventilation systems. However, pneumatic generators for medical applications have specific requirements that more general pneumatic generators cannot meet, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical treatment may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0075] One example of a specific requirement for certain RPT devices is noise.

[0076] A table showing the noise output levels of an existing RPT device (only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0077]

[0078] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators, such as the ResMedStellar™ series of adult and pediatric ventilators, can provide invasive and non-invasive non-dependent ventilatory support for a range of patients to treat a variety of conditions, including but not limited to NMD, OHS, and COPD.

[0079] Therapeutic ResMed Elisée™ 150 and Therapeutic ResMed VS III™ ventilators provide invasive and non-invasive dependent ventilation support for adults and pediatric patients to treat a variety of conditions. These ventilators offer volumetric and pressure ventilation modes with single-limb or dual-limb circuits. RPT devices typically include a pressure generator, such as a motor-driven blower or a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, the airflow can be supplied to the patient's airway at positive pressure. The RPT device outlet is connected via an air circuit to a patient interface such as those described above.

[0080] The designer of the device is presented with an infinite number of options to make. Design standards often conflict, meaning that some design choices are unconventional or unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to minute, subtle changes in one or more parameters.

[0081] 2.2.3.4 Air Circuit

[0082] 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 inspiratory and expiratory breathing. In other cases, a single branch air circuit is used for both inspiratory and expiratory breathing.

[0083] The air circuit can engage with the patient interface and / or sealing structure, or optionally, when using a catheter tip, with a connection port that is in fluid communication with or connected to the catheter tip.

[0084] 2.2.3.5 Ventilation technology

[0085] Some forms of therapeutic systems may include vents to allow for the flushing of exhaled carbon dioxide. Vents can allow gas to flow from the internal space of the patient interface, such as an inflation chamber, to the outside of the patient interface, such as the surrounding environment.

[0086] The vent may include an opening through which gas can flow during the use of the mask. Many such vents are noisy. Others may become clogged during use and therefore provide insufficient flushing. Some vents may, for example, disrupt the sleep of the patient's bed partner by causing noise or concentrated airflow.

[0087] 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.

[0088] The noise level of the existing face mask (ISO 17510-2:2007, 10 cmH2O pressure 1m)

[0089]

[0090] ( (Single sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744)

[0091] The sound pressure levels for various objects are listed below:

[0092] 3. Summary of the Invention

[0094] 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.

[0095] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0096] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0097] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0098] One aspect of this technology includes a patient interface for delivering a pressurized airflow to the patient's airway inlet.

[0099] One aspect of this technology relates to a patient interface for delivering a pressurized airflow from an air circuit to an inlet of a patient's airway, the patient interface comprising:

[0100] Inflation chamber;

[0101] A sealing structure is provided to the inflation chamber;

[0102] One or more connection ports configured to receive airflow from the air circuit and deliver the airflow via the sealing structure to the inlet of the patient's airway; and

[0103] One or more positioning and stabilizing structures are configured to provide, during use, a force that holds the sealing structure in a therapeutically effective position on the patient's head.

[0104] The patient interface is configured and arranged to be worn by a patient in both a first and a second use configuration.

[0105] In this first usage configuration, the air circuit is connected to one or more connection ports positioned above the patient's supra-auricular point, and

[0106] In this second usage configuration, the air circuit is connected to one of the one or more connection ports positioned below the patient's supra-auricular point.

[0107] In one example, the one or more positioning and stabilizing structures include first and second positioning and stabilizing structures configured to be interchangeably provided as part of the patient interface, wherein a) the first positioning and stabilizing structure is configured to be used with the patient interface in a first usage configuration, and b) the second positioning and stabilizing structure is configured to be used with the patient interface in a second usage configuration.

[0108] In this example, the first positioning and stabilizing structure includes at least one gas delivery tube configured and arranged to contact, in use, at least a region of the patient's head above the supraaural point, wherein the portion of the gas delivery tube above the supraaural point is provided to the connection port.

[0109] In this example, the second positioning and stabilizing structure includes one or more straps configured and arranged to contact at least a region of the patient's head above the supraaural point. Furthermore, in this example, in the second usage configuration, a connection port to which the air circuit is connected is provided to the front side of the inflation chamber. In this example, the one or more connection ports may include first and second connection ports, wherein the first connection port is provided to the first positioning and stabilizing structure, wherein the portion of the gas delivery tube above the supraaural point of the patient's head is provided with the first connection port, and wherein the second connection port is provided to the front side of the inflation chamber; and wherein a) when the air circuit is connected to the first connection port in the first usage configuration, the second connection port receives a ventilation structure or a stop; and b) when the air circuit is connected to the second connection port in the second usage configuration, the first connection port receives a ventilation structure or a stop.

[0110] In another example, the one or more positioning and stabilizing structures include a positioning and stabilizing structure comprising at least one gas delivery tube configured and arranged to contact, in use, at least a region of the patient's head above the supraaural point, and the one or more connection ports include a first connection port and a second connection port, the first connection port being disposed on a portion of the gas delivery tube above the supraaural point of the patient's head, and the second connection port being disposed on the front side of the inflation chamber, wherein the patient interface further includes one or more ventilation structures or stops, each ventilation structure or stop being configured to connect to the first and / or second connection ports, and wherein in a first usage configuration, the air circuit is connected to the first connection port and one of these ventilation structures or stops is connected to the second connection port, and in a second usage configuration, the air circuit is connected to the second connection port and one of these ventilation structures or stops is connected to the first connection port.

[0111] In some examples: (a) the first and second connection ports are provided with closures; (b) the closure is configured to be movable from a closed state to an open state; (c) the closure includes an opening and at least one closure cover that covers at least a portion of the opening when in the closed state; (d) the closure includes a ring structure surrounding the opening; (e) the closure cover is pivotally hinged to the ring structure via an outer edge; (f) the closure cover is slidably mounted to the ring structure, wherein the ring structure is provided with a track, and the closure cover is configured to slide along the track; (g) the closure includes an opening and at least one closure flap that covers the opening when in the closed state. At least a portion of the opening is provided and is arranged to be biased from the closed state to the open state through the end of the air circuit; (h) the closure includes a ring structure surrounding the opening; (i) the at least one closure flap is pivotally hinged to the ring structure via its outer edge; (j) the at least one closure flap is pivotally hinged to a support spanning the opening of the ring; (k) at least one closure cover spans the opening or ring structure and is provided with a central orifice, the size of which increases when the closure is biased from the closed state to the open state by the end of the air circuit; (l) the end of the air circuit includes an actuation mechanism arranged to act on The closure includes: (m) an air vent in the form of one or more openings on the closure cover or closure flap; (n) two or more closure flaps, wherein the air vent is a slit formed by the distance between adjacent closure flaps; (o) four closure flaps attached to the inner surface of the closure, wherein the air vent is two intersecting slits formed by the distance between adjacent closure flaps; and (p) when in the open state, the closure allows airflow to be delivered to the inlet of the patient's airway, wherein when in the first use configuration, the closure of the first connection port... The closure is in the open state and the closure of the second connection port is in the closed state, and wherein when in the second use configuration, the closure of the first connection port is in the closed state and the closure of the second connection port is in the open state; (q) the patient interface includes more than one inflatable chamber, wherein each inflatable chamber is configured to be interchangeably included as part of the patient interface; (r) the patient interface includes more than one sealing formation, wherein each sealing formation is configured to be interchangeably included as part of the patient interface; and / or the inflatable chamber and / or the sealing formation is configured as one or more of the following: a nasal mask, a nasal pad, a nasal pillow, or a full-face mask.

[0112] In yet another example, the one or more positioning and stabilizing structures include first and second positioning and stabilizing structures, wherein a) the first positioning and stabilizing structure includes at least one gas delivery tube, and b) the second positioning and stabilizing structure includes one or more straps, and the one or more connection ports include a connection port disposed to the first positioning and stabilizing structure, wherein in the first usage configuration, the first positioning and stabilizing structure is worn to contact a region of the patient's head at least above the supraaural point of the patient's head, and the connection port receives airflow from the air circuit, and in the second usage configuration, the second positioning and stabilizing structure is worn to contact a region of the patient's head at least above the supraaural point of the patient's head, and the connection port receives airflow from the air circuit.

[0113] In this example, the gas delivery pipe has a lower end configured to connect to the side of the inflation chamber, wherein the connection between the gas delivery pipe and the side of the inflation chamber is configured such that the first positioning and stabilizing structure can move between a first connection position in a first use configuration and a second connection position in a second use configuration.

[0114] In one example, the one or more positioning and stabilizing structures include a positioning and stabilizing structure comprising at least one gas delivery tube configured and arranged to contact, in use, at least a region above the supraaural point on the patient's head, and the one or more connection ports including a first connection port and a second connection port, the first connection port being disposed on a portion of the gas delivery tube above the supraaural point on the patient's head, and the second connection port being disposed on the front side of the inflation chamber, wherein the first and second connection ports are provided with closures, wherein the closures are configured to be movable from a closed state to an open state, wherein when in the open state, the closures allow airflow to be delivered to the inlet of the patient's airway, and wherein when in a first use configuration, the closure of the first connection port is in the open state and the closure of the second connection port is in the closed state, and wherein when in a second use configuration, the closure of the first connection port is in the closed state and the closure of the second connection port is in the open state.

[0115] It should be understood that the downstream end of the air circuit is interchangeably connected to the first and second connection ports such that, in the first use configuration, the downstream end of the air circuit is higher than the patient's supraauricular point, while in the second use configuration, the downstream end of the air circuit is lower than the patient's supraauricular point.

[0116] In the example, the patient interface includes more than one air chamber, wherein each air chamber is configured to be interchangeably included as part of the patient interface.

[0117] In the example, the patient interface includes more than one sealing formation structure, wherein each sealing formation structure is configured to be interchangeably included as part of the patient interface.

[0118] In the example, the inflatable chamber and / or sealing structure is configured as one or more of the following: a nose mask, a nose pad, a nose pillow, or a full-face mask.

[0119] One aspect of this technology relates to a patient interface for delivering a pressurized airflow from an air circuit to an inlet of a patient's airway, the patient interface comprising:

[0120] Inflation chamber;

[0121] A sealing structure is provided to the inflation chamber;

[0122] A first positioning and stabilizing structure configured to provide force to hold the sealing structure in a therapeutically effective position on the patient's head during use, wherein the first positioning and stabilizing structure includes at least one gas delivery tube configured and arranged to contact at least a region above the supraaural point of the patient's head in a first use configuration, wherein the portion of the gas delivery tube above the supraaural point of the patient's head is provided with a first connection port for receiving airflow from the air circuit and, in the first use configuration, delivering the airflow via the sealing structure to the inlet of the patient's airway; and

[0123] A second positioning and stabilizing structure is configured to provide force to hold the sealing structure in a therapeutically effective position on the patient's head during use, wherein in a second use configuration, the second positioning and stabilizing structure is constructed and arranged to contact at least a region on the patient's head above the ear point.

[0124] A second connection port for receiving airflow from the air circuit, wherein the second connection port is provided to the front side of the inflation chamber, and wherein, in the second usage configuration, the second connection port receives airflow from the air circuit to deliver the airflow to the sealing structure; and

[0125] A ventilated structure or stop is configured to connect to the second connection port in the first usage configuration.

[0126] It should be understood that the air circuit is interchangeably connected to the first and second connection ports such that, in the first usage configuration, the downstream end of the air circuit is higher than the patient's supra-auricular point, while in the second usage configuration, the downstream end of the air circuit is lower than the patient's supra-auricular point.

[0127] In several examples, the patient interface includes a ventilation structure, which is provided for: a) an inflation chamber; b) a hermetically sealed structure; or c) a gas delivery tube.

[0128] In the example, the patient interface includes more than one air chamber, wherein each air chamber is configured to be interchangeably included as part of the patient interface.

[0129] In the example, the patient interface includes more than one sealing formation structure, wherein each sealing formation structure is configured to be interchangeably included as part of the patient interface.

[0130] In the example, the inflatable chamber and / or sealing structure is configured as one or more of the following: a nose mask, a nose pad, a nose pillow, or a full-face mask.

[0131] Another aspect of this technology relates to a patient interface for delivering a pressurized airflow to an inlet of a patient's airway, the patient interface comprising:

[0132] Inflation chamber;

[0133] A sealing structure is provided to the inflation chamber; and

[0134] A positioning and stabilizing structure configured to provide force to hold the sealing structure in a therapeutically effective position on the patient's head during use, wherein the positioning and stabilizing structure includes at least one gas delivery tube constructed and arranged to contact at least a region above the supraaural point on the patient's head, wherein the portion of the gas delivery tube above the supraaural point on the patient's head is provided with a first connection port to receive airflow from the air circuit in a first use configuration and to deliver the airflow via the sealing structure to the inlet of the patient's airway.

[0135] The front side of the inflation chamber is provided with a second connection port to receive airflow from the air circuit in the second usage configuration and to deliver the airflow to the inlet of the patient's airway via the sealing structure.

[0136] The patient interface further includes one or more ventilation structures or stops, each ventilation structure or stop being configured to connect to the first and / or second connection port, and wherein in the first usage configuration, the air circuit is connected to the first connection port and one of the ventilation structures or stops is connected to the second connection port, and in the second usage configuration, the air circuit is connected to the second connection port and one of the ventilation structures or stops is connected to the first connection port.

[0137] It should be understood that the air circuit is interchangeably connected to the first and second connection ports such that, in the first usage configuration, the downstream end of the air circuit is higher than the patient's supra-auricular point, while in the second usage configuration, the downstream end of the air circuit is lower than the patient's supra-auricular point.

[0138] In several examples, the patient interface includes a ventilation structure, which is provided for: a) an inflation chamber; b) a hermetically sealed structure; or c) a gas delivery tube.

[0139] In one example, one or more venting structures or stops include a venting structure configured to connect to a second connection port in a first usage configuration and to a first connection port in a second usage configuration. In another example, the one or more venting structures or stops include a stop configured to connect to the second connection port in the first usage configuration and to the first connection port in the second usage configuration.

[0140] In the example, the inflatable chamber and / or sealing structure is configured as one or more of the following: a nose mask, a nose pad, a nose pillow, or a full-face mask.

[0141] Another aspect of this technology relates to a patient interface for delivering a pressurized airflow from an air circuit to an inlet of a patient's airway, the patient interface comprising:

[0142] Inflation chamber;

[0143] A sealing structure is provided to the inflation chamber; and

[0144] A first positioning and stabilizing structure, configured to provide force to hold the sealing structure in a therapeutically effective position on the patient's head during use, wherein the first positioning and stabilizing structure includes at least one gas delivery tube configured and arranged to contact at least a region above the supraaural point of the patient's head in a first use configuration, wherein in the first use configuration, the portion of the gas delivery tube above the supraaural point of the patient's head is provided to the connection port for receiving airflow from the air circuit and delivering the airflow via the sealing structure to the inlet of the patient's airway, and wherein the gas delivery tube has a lower end configured to connect to one side of the inflation chamber; and

[0145] A second positioning and stabilizing structure, configured to provide force to hold the sealing structure in a therapeutically effective position on the patient's head during use, includes at least one band constructed and arranged to contact, in a second use configuration, at least a region on the patient's head above the supraacular point.

[0146] The lower end of the gas delivery pipe is connected to the side of the inflation chamber in a manner that allows the first positioning and stabilizing structure to be movably connected between the first usage configuration and the second usage configuration.

[0147] In the second usage configuration, the connection port is below the ear tip.

[0148] Another aspect of this technology relates to a patient interface for delivering a pressurized airflow to an inlet of a patient's airway, the patient interface comprising:

[0149] Inflation chamber;

[0150] A sealing structure is provided to the inflation chamber; and

[0151] A positioning and stabilizing structure configured to provide force to hold the sealing structure in a therapeutically effective position on the patient's head during use, wherein the positioning and stabilizing structure includes at least one gas delivery tube constructed and arranged to contact at least a region above the supraaural point on the patient's head, wherein the portion of the gas delivery tube above the supraaural point on the patient's head is provided with a first connection port to receive airflow from the air circuit in a first use configuration and to deliver the airflow via the sealing structure to the inlet of the patient's airway.

[0152] The front side of the inflation chamber is provided with a second connection port to receive airflow from the air circuit in the second usage configuration and to deliver the airflow to the inlet of the patient's airway via the sealing structure.

[0153] The first connection port and the second connection port are each configured to have a closure, wherein the closure is arranged to be movable from a closed state to an open state, wherein when in the open state, the closure allows airflow to be delivered to the inlet of the patient's airway, and wherein when in the first use configuration, the closure of the first connection port is in the open state and the closure of the second connection port is in the closed state, and wherein when in the second use configuration, the closure of the first connection port is in the closed state and the closure of the second connection port is in the open state.

[0154] It should be understood that the downstream end of the air circuit is interchangeably connected to the first and second connection ports such that, in the first use configuration, the downstream end of the air circuit is higher than the patient's supraauricular point, while in the second use configuration, the downstream end of the air circuit is lower than the patient's supraauricular point.

[0155] In the examples, the closure includes an opening and at least one closure cover that covers at least a portion of the opening when in a closed state. In these examples, the closure further includes a ring structure surrounding the opening, and the closure cover a) is pivotally hinged to the ring structure via its outer edge; or b) is slidably mounted to the closure, wherein the closure is provided with a track along which the closure cover is configured to slide.

[0156] In other examples, the closure includes an opening and at least one closing flap that covers at least a portion of the opening when in a closed state and is arranged to be biased from a closed state to an open state via a downstream end of the air circuit. In these examples, the closure further includes a ring structure surrounding the opening, and the at least one closing flap a) is pivotally hinged to the ring structure via an outer edge; or b) is pivotally hinged to a strut spanning the opening of the ring structure; or c) spans the opening and is provided with a central orifice whose size increases when the closure is biased from the closed state to the open state by the downstream end of the air circuit.

[0157] In another example, the actuation mechanism may be located at or near the downstream end of the air circuit to act on the closure in response to the establishment of a connection between the air circuit and the connection port. In this example, the actuation mechanism may be configured as a protrusion or multiple protrusions that abut against the surface of the closure to move it from a closed state to an open state. In this example, the closure may be temporarily deformable or biased, so that the closure can return to a closed state once the downstream end of the air circuit has been removed.

[0158] In the examples, the closure also includes a vent. In these examples, the vent is in the form of one or more openings provided in the closure cover or fold. In other examples, where the closure includes two or more closure folds, the vent is in the form of a slit formed by the distance between adjacent closure folds.

[0159] One aspect of this technology relates to a patient interface for delivering a pressurized airflow to an inlet of a patient's airway, the patient interface comprising:

[0160] Inflation chamber;

[0161] A sealing structure is provided to the inflation chamber; and

[0162] A positioning and stabilizing structure configured to provide force to hold the sealing structure in a therapeutically effective position on the patient's head during use, wherein the positioning and stabilizing structure includes at least one gas delivery tube constructed and arranged to contact at least a region above the supraaural point on the patient's head, wherein the portion of the gas delivery tube above the supraaural point on the patient's head is provided with a first connection port to receive airflow from the air circuit in a first use configuration and to deliver the airflow via the sealing structure to the inlet of the patient's airway.

[0163] The front side of the inflation chamber is provided with a second connection port to receive airflow from the air circuit in the second usage configuration and to deliver the airflow to the inlet of the patient's airway via the sealing structure.

[0164] The first connection port and the second connection port are each configured to have a closure, wherein the closure is arranged to be movable from a closed state to an open state, wherein when in the open state, the closure allows airflow to be delivered to the inlet of the patient's airway, and wherein when in the first use configuration, the closure of the first connection port is in the open state and the closure of the second connection port is in the closed state, and wherein when in the second use configuration, the closure of the first connection port is in the closed state and the closure of the second connection port is in the open state.

[0165] It should be understood that the air circuit can be interchangeably connected to the connection port such that, in the first use configuration, the downstream end of the air circuit is higher than the patient's supra-auricular point, while in the second use configuration, the downstream end of the air circuit is lower than the patient's supra-auricular point.

[0166] In the example, the inflatable chamber and / or sealing structure is configured as one or more of the following: a nose mask, a nose pad, a nose pillow, or a full-face mask.

[0167] Another aspect of this technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0168] One aspect of this technology is a method for manufacturing equipment.

[0169] 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, vision, or by a person with limited experience in using this type of medical device.

[0170] One aspect of this technology is a patient interface that can be used in a patient's home, for example, by washing it in soapy water, without the need for specialized cleaning equipment.

[0171] Of course, some of these aspects can form sub-aspects of this technology. Furthermore, sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0172] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. 4. Attached Figure Descriptions

[0174] The technology is illustrated in the accompanying drawings by way of example and not limitation, and the same reference numerals in the drawings denote similar elements, including:

[0175] 4.1 Respiratory Therapy System

[0176] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure airflow or 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 partner 1100 is also shown. The patient sleeps in a supine position.

[0177] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive pressure airflow or 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.

[0178] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face mask receives a positive-pressure airflow or air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying position.

[0179] 4.2 Facial Anatomy

[0180] Figure 2 It is a side view of the head with several features of the surface anatomy, including the identified supraauricular and subauricular points. The up-down and front-back directions are also indicated.

[0181] 4.3 Patient Interface

[0182] Figure 3AA patient interface in the form of a full-face mask in a first use configuration is shown according to the present technology.

[0183] Figure 3B An example of a second usage configuration according to the present technology is shown. Figure 3A The patient interface.

[0184] Figure 4A A patient interface in the form of a nasal pad in a first use configuration is shown according to the present technology.

[0185] Figure 4B An example of a second usage configuration according to the present technology is shown. Figure 4A The patient interface.

[0186] Figure 5A It shows Figure 4A and Figure 4B A close-up view of the nasal pad at the patient interface.

[0187] Figure 5B It shows Figure 4A and Figure 4B A close-up view of the coronal connector of the patient interface.

[0188] Figure 6 An alternative second usage configuration according to the present technology is shown. Figure 4A The patient interface.

[0189] Figure 7 A rigid connector for a tube in one form of catheter head sleeve according to the present technology is shown.

[0190] Figure 8A It shows the use of with Figure 6 The adapter for the catheter head sleeve is used in the form of this technology.

[0191] Figure 8B It shows the use of with Figure 6 This technology is used in the form of a catheter head sleeve as a replacement adapter for the tube.

[0192] Figure 9 Another form of patient interface according to this technology is shown.

[0193] Figure 10 Another form of patient interface according to this technology is shown.

[0194] Figure 11 A first example of a closure for a patient interface of another form according to the present technology is shown.

[0195] Figure 12AAnother example of a closure for a patient interface, according to another form of the present technology, is shown.

[0196] Figure 12B It shows that it is in the open state. Figure 12A The closure component.

[0197] Figure 13A Another example of a closure for a patient interface, according to another form of the present technology, is shown.

[0198] Figure 13B A bend with an air circuit is shown. Figure 13A The cross-section of the closed component.

[0199] Figure 13C It shows that it is in the open state. Figure 13A and Figure 13B The cross-section of the closed component.

[0200] Figure 14A Another example of a closure for a patient interface, according to another form of the present technology, is shown.

[0201] Figure 14B The screen is shown as closed. Figure 14A The cross-section of the closed component.

[0202] Figure 14C It shows that it is in the open state. Figure 14A and Figure 14B The cross-section of the closed component.

[0203] Figure 14D It shows Figures 14A-14C The cross-section of the closure includes the hinges used to close the fold.

[0204] Figure 15 Another example of a closure for a patient interface, according to another form of the present technology, is shown. 5. Detailed Implementation

[0206] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0207] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any example may be combined with one or more features of another example or other examples. In addition, in any example, any single feature or combination of features may constitute another example.

[0208] 5.1 Treatment

[0209] In one form, the technology includes a method for treating respiratory disorders, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0210] In some examples of this technique, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0211] In some examples of this technique, mouth breathing is limited, restricted, or prevented.

[0212] 5.2 Respiratory Therapy System

[0213] In one form, this technology includes a respiratory therapy system for treating respiratory disorders. For example... Figures 1A to 1C As shown, the respiratory therapy system may include an RPT device 4000 for supplying a pressurized airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0214] 5.2.1 Air Circuit

[0215] The air circuit includes a conduit that delivers a pressurized airflow to the patient interface. It is typically a section of tubing made of biocompatible plastic material, fluidly connected upstream to the RPT device 4000 and downstream to the patient interface 3000. In some examples, the downstream end of the air circuit 4170 is configured as a connector that engages with the patient interface 3000. This engagement can be via a snap-lock fit, complementary threads, or a similar arrangement.

[0216] 5.2.2 Patient Interface

[0217] According to one aspect of the present technology, the non-invasive patient interface 3000 includes the following functional aspects: a sealing forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, a ventilation structure 3400, and a connection port 3600A or 3600B for connection to the downstream end of the air circuit 4170.

[0218] In some forms, functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the inlet of the patient's airway 1000. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0219] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0220] In one embodiment of the present invention, the patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 6 cmH2O relative to the environment. In another embodiment of the present invention, the patient interface is constructed and arranged to supply air at a positive pressure of at least 10 cmH2O relative to the environment. In yet another embodiment of the present invention, the patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 20 cmH2O relative to the environment.

[0221] 5.2.3 Sealing Formation Structure

[0222] In one form of this technology, the patient interface includes a seal-forming structure 3100 that provides a target seal-forming area and may additionally provide cushioning functionality. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The area where a seal actually 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 position of the patient interface on the face, the tension in the positioning and stabilizing structures, and the shape of the patient's face.

[0223] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0224] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material such as silicone rubber.

[0225] The sealing structure 3100 according to this technology can be made of a soft, flexible, elastic material, such as silicon.

[0226] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each sealing formation structure 3100 being configured to correspond to a different range of sizes and / or shapes. For example, the system may include one type of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0227] 5.2.3.1 Sealing Mechanism

[0228] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure acting on its bottom surface within the inflation chamber 3200, thereby forming a tight seal with the face. This pressure-assisted mechanism can work in conjunction with the elastic tension in the positioning and stabilizing structure.

[0229] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends for at least a portion of the path around the periphery. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from buckling during use.

[0230] In one form, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and arranged in a compressed state, for example, as a result of elastic tension in the positioning and stabilizing structure.

[0231] In one form, the sealing structure includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by adjacent areas of the sealing flange.

[0232] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0233] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having an adhesive or bonding surface.

[0234] 5.2.4 Inflation Chamber

[0235] The patient interface 3000 includes an inflatable chamber 3200 having a periphery shaped to complement the surface contours of a typical person's face in an area that will form a seal during use. In one form of the technology, the inflatable chamber may be part of a full-face mask, mouth and nose, nasal mask, nasal pillow, or nasal pad.

[0236] In use, the boundary edge of the inflation chamber 3200 is positioned very close to the adjacent surface of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 may extend along 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.

[0237] The inflatable chamber has a front side, which should be understood as the outer surface of the inflatable chamber facing away from the patient during use. In some forms of this technology, the inflatable chamber may include two or more components. In one example, the front surface may include a portion of a rigid housing, to which other portions of the inflatable chamber are permanently attached or mounted, either by means of appropriate bonding or overmolding techniques or by means of complementary or snap-locking fasteners.

[0238] In some examples, the inflatable chamber and / or sealing structure can be configured to be removed from the patient interface and replaced by another inflatable chamber and / or sealing structure, such as those structurally different in some way, for example, those of different sizes, types, or shapes. This allows the patient to exchange, for example, between an inflatable chamber and a sealing structure configured as a nasal mask, full-face mask, nasal pad, and nasal pillow, or between small, medium, and large masks of the same type. The inflatable chamber and sealing structure can be formed as sub-components or modules to make this interchangeability more convenient for the patient.

[0239] The inflation chamber has a rear side, which should be understood as the inner surface of the inflation chamber. The rear side of the inflation chamber provides a sealing structure that receives the patient's nose and / or mouth during use.

[0240] 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 a form tends to be less conspicuous and / or more comfortable for the wearer, which can improve treatment adherence.

[0241] In some forms of this technology, the air chamber 3200 is made of a transparent material, such as transparent polycarbonate. Using a transparent material reduces the prominence of the patient interface and helps improve treatment adherence. The transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0242] In some forms of this technology, the air chamber 3200 is made of a translucent material. The use of a translucent material can reduce the protrusion of the patient interface and help improve treatment adherence.

[0243] 5.2.5 Positioning and Stabilizing Structure

[0244] When worn by a patient, the sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position by using the positioning and stabilizing structure 3300. The positioning and stabilizing structure 3300 may be referred to as a "headgear" because it contacts and engages with the patient's head to hold the patient interface 3000 in a sealed position.

[0245] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure in the inflation chamber 3200 to lift the face away.

[0246] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the gravitational effects on the patient interface 3000.

[0247] 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.

[0248] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with that worn by a patient 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 the device.

[0249] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying down in a supine sleeping position, wherein the back area of ​​the patient's head rests on a pillow.

[0250] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying on the pillow in a side-sleeping position with the side of the patient's head on the pillow.

[0251] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. This decoupling portion does not resist compression and may be, for example, a flexible band or soft band. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, its presence prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0252] 5.2.5.1 Headgear

[0253] In one form of this technology, the positioning and stabilizing structure 3300 is in the form of a headband arrangement 3300B, such as... Figure 3B As shown. The headband arrangement 3300B includes one or more straps 3330 arranged to form a cup for the back of the patient's head. These straps work together to hold the patient interface in proper position on the patient's face.

[0254] The band 3330 may be composed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the band 3330. The band 3330 may be breathable to allow moisture to permeate through the band. In one form, the fabric outer layer includes a loop material for engagement with the hook material portion.

[0255] In some forms of this technology, the strap 3330 of the positioning and stabilizing structure 3300B is configured to be extendable, for example, elastically extendable. For example, the strap may be configured to be tensioned during use and to guide the sealing-forming structure into a sealing contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0256] In some forms of this technology, the strap 3330 of the positioning and stabilizing structure 3300B is included as flexible and, for example, non-rigid. The advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping. The strap 3330 has sufficient flexibility to wrap around the back of the patient's head and rest comfortably against the patient's head, even under tension during use.

[0257] In some examples of this technology, the positioning and stabilizing structure 3300B is configured to receive the band 3330 at a location above and near the patient's ear. If the band 3330 is connected to the positioning and stabilizing structure too high relative to the patient's head, the band 3330 may tend to drape upwards over the back of the patient's head. Additionally, the band 3330 may form too large an angle relative to the upper part of the positioning and stabilizing structure 3300B, causing the patient to need to excessively tighten the band 3330, which could result in excessive tension in the positioning and stabilizing structure 3300B and make the band 3330 more likely to drape over the back of the patient's head. Therefore, it is advantageous that the connection between the band 3330 and the positioning and stabilizing structure 3300B is provided as low as possible but spaced sufficiently from the top of the patient's ear so that when the band 3330 is tightened, the positioning and stabilizing structure is not pulled into contact with the patient's ear, as this could cause discomfort.

[0258] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300B, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300B suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0259] 5.2.5.2 Gas delivery pipe

[0260] In some forms of this technology, for example Figure 3A and Figure 4A The form, positioning, and stabilizing structure 3300A includes one or more gas delivery pipes 3310, 3320, which, for example, pass through an inflation chamber 3200 and a sealing structure (in Figure 3A(Not visible in the image) Pressurized air received from the air circuit 4170 is delivered from the RPT device to the patient's airway. In these forms, the positioning and stabilizing structure 3300 may be referred to as the catheter head 3300A, and in addition to delivering pressurized air to the airway, it is used to position and stabilize the sealing forming structure 3100 of the patient interface to the appropriate portion of the patient's face (the terms tube and catheter should be understood to be interchangeable). In these forms, the catheter head contacts at least the area above the ear point on the patient's head. Figure 2 As shown, the supra-auricular point is the point on the side of the patient's head where the upper part of the ear is located.

[0261] In one example, tubes 3310 and 3320 can be substantially cylindrical. However, in other examples, the tubes can be formed with various cross-sectional shapes. For example, a substantially D-shaped cross-sectional profile can be used; the flat side of this profile can contact the patient's face when worn and can be more comfortable than a semi-circular profile.

[0262] In some forms of this technology, the conduit head includes a pair of tubes 3310, 3320 that deliver pressurized air from the downstream end of the air circuit to the sealing structure. As an example, in Figure 4A In the middle section, tubes 3310 and 3320 are connected at their upper ends to a coronal connector 3360 with a connection port 3600A for fluid engagement with the downstream end of the air circuit, forming an integral part of the positioning and stabilization structure of the patient interface. At their lower ends, the tubes are connected to the patient interface 3000 via air inlet ports 3210 and 3220. The tubes can be disconnected, for example, for cleaning or storage.

[0263] In some forms of this technology, such as Figure 4A As shown, the catheter head 3300A includes left and right tubes 3310, 3320, which are fluidly engaged or otherwise connected at their lower ends to a patient interface 3000, in this form, a full-face shield 3010, to deliver pressurized air to the sealed structure. A connection port 3600A, engaging with the downstream end of an air circuit 4170, is provided at the upper part of the catheter head 3300A, where the two arms 3310, 3320 of the tubes meet. At their lower ends, the arms are connected to the patient interface 3000 through air inlet ports near the ends of the tubes 3210, 3220. In this example, the catheter head is essentially a single-piece structure.

[0264] exist Figure 3A and Figure 4AIn the example shown, when the catheter tip 3300A is worn, the connection port 3600A is typically located on the patient's coronal region. However, it should be understood that the connection port 3600A can be provided in different locations depending on the shape of the catheter tip. For example, tubes 3310 and 3320 could be arranged to meet further posteriorly against the back of the patient's head, rather than across the coronal region. This would place the connection port closer to a portion of the back of the patient's head rather than the coronal region. Alternatively, the connection port 3600A could be provided elsewhere, such as to one of the two tubes 3310 and 3320 instead of where they meet.

[0265] In some instances of this technology, the catheter tip 3300A is formed of a suitable elastic material that provides sufficient stabilizing force to properly position the patient interface in a sealed arrangement on the patient's head. In some other examples, the positioning and stabilizing structure includes mechanisms for attaching the tip band 3390 or other stabilizing components to the tip cannula. The tip band can supplement the stabilizing force provided by the catheter tip and help to properly position the patient interface in a sealed arrangement on the patient's head.

[0266] In these examples, the headgear strap can be directly or indirectly connected to the headgear tubes 3310 and 3320. Figure 4A and Figure 4B In the case of the patient interface shown, for example, a tab 3380 configured to attach to a shoulder strap 3390 protrudes from tubes 3310 and 3320 in a generally rearward direction. The tab 3380 has a slit to receive the end of the strap 3390.

[0267] The carrying strap 3390 can be secured to itself, for example, using a hook-and-loop fastening material, after passing through a slit in the tab 3380. Therefore, the carrying strap 3390 can be adjusted to fit different head sizes. In some forms of this technology, more than one tab can be provided on the tubes 3310 and 3320 to provide the patient with a range of placement options for the carrying strap 3390. This helps ensure that a proper seal is applied to the face.

[0268] In some examples, the tubes 3310 and 3320 of the catheter tip 3300A may be formed of textiles, spacer fabrics, and / or foam materials. The portions of the tubes 3310 and 3320 that contact the patient may be formed of textiles or fabrics for patient comfort. In some examples, the tubes may be formed of semi-rigid materials, such as elastic materials like silicone. In these examples, the tubes may include thin sleeves of fabric or textiles wrapped around them. Sleeves can provide greater comfort against the patient's face compared to tubes without any covering.

[0269] like Figure 3A and Figure 4AAs shown, in some examples, the tubes 3310, 3320 of the catheter head 3300A may have a natural, pre-shaped form that conforms to the overall shape of the patient's head. In some examples, the tubes 3310, 3320 may have at least some deformability if force is applied to the tube or conforms to the patient's head. For example, the tubes may typically be arched or curved, with a shape approximating the head contour between the top of the patient's head and the nasal or oral region.

[0270] Because air can be contained and passed through the tubes 3310, 3320 of the catheter headgear 3300A to deliver pressurized air from the air circuit 4170 to the patient's airway, the catheter headgear can be described as inflatable. It is understood that an inflatable catheter headgear does not require all its components to be inflatable. For example, when the positioning and stabilization structure includes the headgear tubes 3310, 3320 and the carrying strap 3390, the headgear tubes are inflatable while the carrying strap is not.

[0271] 5.2.6 Ventilation Structure

[0272] In one form, the patient interface 3000 includes a ventilation structure 3400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide. Figure 5A An example is shown where the patient interface is in the form of a nasal pad 3020 (see [link]). Figure 4A and Figure 3A The plug structure 3500 in the middle can be replaced by the vent structure 3400.

[0273] In some configurations, the ventilation structure 3400 is configured to allow continuous ventilation flow from the interior of the inflation chamber 3200 to the surrounding environment, while the pressure within the inflation chamber is positive relative to the surrounding environment. The ventilation structure 3400 is configured such that the ventilation flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the therapeutic pressure within the inflation chamber during use.

[0274] One form of the ventilation structure 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0275] In one embodiment of this technology, the ventilation structure 3400 may be configured as an integral part of the inflation chamber and / or sealing structure. In another embodiment, the ventilation structure may be an integral part of the connection ports 3600A, 3600B. In yet another embodiment, the ventilation structure may be an integral part of the positioning and stabilization structure. In other embodiments of this technology, the ventilation structure 3400 may be a separate component of the inflation chamber, sealing structure, connection port, and / or positioning and stabilization structure, but may also be provided for one of these components. The ventilation structure may be removable for cleaning and replacement. In some embodiments of this technology, the patient interface may be provided with more than one ventilation structure.

[0276] In one form of this technology, the ventilation structure 3400 is formed from a rigid medical-grade plastic material. In an alternative form, the ventilation structure is formed from a soft woven mesh. In these forms, the mesh can be defined by a rigid or semi-rigid frame to give the ventilation structure some structural integrity. In other forms, it can be formed from a rigid plastic material as a molded part.

[0277] like Figure 5A As shown, the venting structure 3400 can be configured to connect to the connection port 3600B in the inflation chamber 3200. For example, the venting structure 3400 may be generally circular in plan view, or may include a generally circular connector for connecting to the connection port 3600B.

[0278] In one form, it can be found in nose pad 3020 (see...) Figure 4A and Figure 4B One or more additional ventilation structures 3400A are provided in the full face mask 3010 and / or the full face mask 3010. For example... Figure 4A As shown, venting structures 3400 and / or 3400A can be configured as part of the inflation chamber 3200. For example, venting structure 3400A can be a slot or a circle in the plan view. Alternatively, or in addition to venting structures in the inflation chamber, the venting structure can be configured as follows: Figure 4B Part of the coronal connector 3360 of the catheter head 3300A shown.

[0279] 5.2.7 Connection Port

[0280] Connection ports 3600A and 3600B allow the patient interface 3000 to be connected to the downstream end of the air circuit 4170.

[0281] In some examples, for example Figure 3A and Figure 4AIn the example shown, connection ports 3600A and 3600B may include a bend 3610 received in a fluid connection opening of the patient interface 3000. This bend may be received in a ring within the fluid connection opening and may be configured to rotate within the ring. The fluid connection opening may also be considered as the connection port itself.

[0282] When using this technology, the location of the connection ports 3600A and 3600B, and therefore the location of the downstream end of the air circuit 4170 connected to the patient interface 3000, depends on whether the patient has selected to wear the patient interface in the first or second use configuration.

[0283] 5.2.8 Enclosure

[0284] In one embodiment, the connection ports 3600A and 3600B of the patient interface 3000 and the catheter tip 3300A include a closure 3786. This closure is arranged to be movable between a closed state where the connection port is substantially sealed and an open state where pressurized air from the air circuit can flow into the connection port. When the air circuit is not connected, the closure allows the patient to seal or substantially close the connection port. The closure may be a separate component, inserted by the patient as needed, or integrally formed as part of the connection port.

[0285] In one form of this technology, the closure 3786 is formed from a rigid medical-grade plastic material. In an alternative form, the closure is formed from a softer, semi-rigid material such as silicone. In these forms, the closure may be defined by a rigid or semi-rigid frame or ring to impart some structural integrity to the closure.

[0286] In some examples, the closure 3786 can be constructed and arranged to allow the washout of exhaled gases, such as carbon dioxide. Figures 11 to 15 The diagram shows non-limiting examples of closures used in these technical forms.

[0287] 5.2.9 First Use Configuration / Second Use Configuration

[0288] In this technology, when wearing the patient interface, the patient can choose between a first usage configuration and a second usage configuration.

[0289] The first usage configuration should be understood as an arrangement in which, when the patient interface 3000 is worn together with the positioning and stabilizing structure 3300 in the form of a catheter tip 3300A, the air circuit 4170 engages with the patient interface at a point higher than the patient's supra-auricular point, i.e., the connection port is higher than the patient's supra-auricular point. In this configuration, Figure 3A and Figure 4AAn example is shown, where the connection port 3600A is provided to the catheter head or configured as part of the catheter head.

[0290] This first configuration places the downstream end of the connection port 3600A and the air circuit 4170 approximately away from the patient's face. Instead, the downstream end of the air circuit is positioned near the upper side of the patient's head before the rest of the air circuit extends downwards or falls along the patient's side or back. The informal term used for this configuration may be "tube up".

[0291] The second usage configuration should be understood as an arrangement in which, when the patient interface 3000 is worn, the downstream end of the air circuit 4170 engages with the patient interface 3000 at a point below the patient's earlobe, i.e., the connection port 3600A is below the patient's earlobe. Figure 3B , Figure 4B and Figure 6 An example of the patient interface 3000 in the second usage configuration is shown.

[0292] In this second usage configuration, the connection port 3600B can be provided to the front of the inflation chamber 3200 or configured as part of the front of the inflation chamber 3200, such as Figure 3B and Figure 4B As shown. In Figure 6 In an alternative example of the second usage configuration shown, the connection port 3600A may be positioned on or configured as part of a positioning and stabilizing structure 3300 in the form of a catheter tip 3300A. In this alternative example, the catheter tip 3300A may have been reversed or otherwise rotated from a first usage configuration (where the catheter tip 3300A contacts an area at least above the supraaural point of the patient's head) to a second usage configuration where the catheter tip 3300A does not contact the head above the supraaural point. In this alternative example, a second positioning and stabilizing structure 3300 may be required, such as multiple headbands included in a headband arrangement 3300B, to ensure that the sealing formation structure 3100 is held in place.

[0293] In these examples, the second usage configuration places the connection port (3600A when part of the catheter headgear, 3600B when part of the inflatable chamber) and the downstream end of the air circuit 4170 near the patient's face or neck. The downstream end of the air circuit is located in front of or below the patient's head, in front of the face or around the chin or neck, before the rest of the air circuit extends or falls down. The informal term for this configuration may be "tube down".

[0294] Patient interfaces where the connection port is not positioned in front of the patient's face may be advantageous for patients who find air circuits connected to front-face patient interfaces unsightly and / or inconspicuous. For example, air circuits connected to front-face patient interfaces may tend to get tangled in bedding or sheets, especially if the air circuit extends downwards from the patient interface during use. This technology features a patient interface with a connection port positioned near the top of the patient's head during use, allowing the patient to lie or sleep more easily or comfortably in one or more of the following positions: in a lateral or sideways position; in a supine position (i.e., with their back facing upwards); and in a prone position (i.e., with their front facing downwards). Furthermore, connecting a catheter to the front of the patient interface can exacerbate a problem known as tube resistance, where the catheter can provide undesirable resistance at the patient interface, causing the patient interface to shift away from the face and jeopardizing treatment during sleep.

[0295] Conversely, patient interfaces where the connection port is positioned in front of the patient's face may be advantageous for some patients, particularly those who are not aware of the air circuit in their line of sight and are being used with this type of patient interface. Some patients may wear the patient interface while awake and when their upper body is roughly upright. The presence of the air circuit to the front of its body can be less prominent and / or easier to manage.

[0296] This technology relates to a patient interface (e.g., a modular patient interface) that allows a patient to choose between a first usage configuration and a second usage configuration, i.e., between "pipe-up" and "pipe-down" configurations. In some cases, trade-offs may exist between these pipe-up and pipe-down configurations.

[0297] For example, an upward-facing tube configuration when wearing a catheter hood can provide increased freedom of movement and less interference. By avoiding the need to connect the air circuit to the patient's front, more freedom of choice is given to the patient. This allows the patient to move more freely or easily face their bed partner during treatment. However, an upward-facing tube configuration is not stable when maintaining a sealed contact between the patient interface and the patient's face, as there may be relatively more limitations when designing a catheter hood that serves dually as both a hood and a tube delivering pressurized air compared to a hood strap design. In cases where the catheter hood is less stable, a more robust seal-forming structure can be provided for the patient interface to compensate for the reduced system stability. In this case, the seal-forming structure can protrude slightly more to achieve a stronger seal compared to a relatively less robust seal-forming structure.

[0298] During treatment, patients can choose to alternate between tube-up or tube-down configurations based on their preference for the increased freedom of movement and less protrusion provided by the catheter shroud, versus the increased stability of a shroud with straps and buckles. Other benefits include the ability to easily switch between the two configurations. For example, a patient can try the initial first "tube-up" configuration because it offers more freedom of movement, and if insufficient seal formation occurs, simply switch the catheter shroud to a standard shroud strap. Another benefit of modular patient interface systems, where the air circuit connection port is located in the patient interface or on top of the catheter shroud, is the reduction in stock units, and therefore lower manufacturing costs and fewer choices between systems.

[0299] In some forms of this technology, the patient interface 3000 can be provided to a patient as a treatment system comprising multiple components that are assembled, connected to each other, and interchangeable according to personal preference. The patient selects the desired patient interface 3000 and positioning and stabilization structure 3300 based on their preference for a "tube-up" or "tube-down" usage configuration. In these forms, the treatment system may include at least: the patient interface 3000, comprising one or more of the following mask types: full face mask 3010, nasal mask, and nasal pad 3020; and the positioning and stabilization structure 3300, comprising a catheter headgear 3300A and optionally a headband arrangement 3300B.

[0300] In some forms of this technology, in addition to the components described above, the treatment system may also include one or more of the following: a connection port 3600; a ventilation structure 3400; a plug structure 3500; and an adapter / connector to facilitate the engagement of the various components, thereby assembling the complete treatment system according to the patient's personal preferences.

[0301] In some forms of this technology, additional vents may be provided. In one example, if present, the catheter head 3300A may include a series of small openings serving as vents. In another example, the sealing structure 3100 may include a series of small openings serving as vents.

[0302] The technique will now be described with reference to certain non-restrictive examples.

[0303] 5.2.9.1 First Example

[0304] An example of this technology is... Figure 3A As shown, the patient interface 3000 is in the first usage configuration.

[0305] The patient interface includes an inflatable chamber and a sealing structure in the form of a full-face mask 3010, which, when worn by the patient, covers and forms a seal around the nose and mouth, as well as a positioning and stabilizing structure 3300 in the form of a catheter head cap 3300A, which has left and right tubes 3310 and 3320. The upper ends of these two tubes are fluidly connected to each other and fluidly connected to a connection port 3600.

[0306] Connection port 3600A is used in conjunction with bend 3610, which receives the downstream end of air circuit 4170. When the catheter tip is worn by the patient, the connection port is positioned above the patient's ear (see [link]). Figure 2 ).

[0307] In this example of the technology, the side of the inflation chamber 3200 of the full-face mask 3010 is provided with left and right air inlet ports 3210 and 3220. The left and right air inlet ports 3210 and 3220 are configured to be in fluid communication with the lower ends 3310A and 3320A of the tubing of the catheter head shroud 3300A. This allows pressurized air to be delivered from the air circuit 4170 to the sealing structure of the patient interface 3000 in the first use configuration. Figure 3A (Not visible in the middle).

[0308] The portions of the air inlet ports 3210, 3220 and the pipes 3310A, 3320A that engage with them are configured to have appropriate attachment mechanisms, such as in the form of complementary convex and concave fittings, such as interlocking grooves and bolts.

[0309] exist Figure 7 An example of an attachment mechanism for connecting the tube to the air inlet port is shown relative to the left tube 3310. The lower end 3310A is provided with a rigid connector 3370 made of, for example, polypropylene, polycarbonate, nylon, etc. This rigid connector engages with the air inlet port 3210 in a sealing arrangement. Alternatively, the attachment mechanism for connecting the left and right tubes to the air inlet ports can be configured as a snap-lock fitting, threaded, or similar.

[0310] In a hard-on-hard connection between tubes 3310, 3320 and the air inlet ports 3210, 3220 of the patient interface 3000, a pressure-activated seal, such as a peripheral sealing flange, can be used. When pressurized gas is supplied through tubes 3310, 3320, the sealing flange is pushed against the joint between the inner circumferential surface of the tube and the air inlet port of the inflation chamber to enhance the seal between them. If the air inlet port is flexible and a rigid connector is provided to the tube, a pressure-activated seal as previously described can also be used to ensure the connection is airtight, although it may not be necessary.

[0311] The full-face mask 3010 also has a connection port 3600B on the front of its inflation chamber. (The last sentence appears to be incomplete and unrelated to the preceding text.) Figure 3A In the first usage configuration of the patient interface shown, the connection port uses either a plug structure 3500 or a ventilation structure 3400. Figure 5A Example 3400 is shown in the diagram. The use of the ventilation structure allows exhaled air to be exhausted to the outside of the patient interface.

[0312] The ventilation structure 3400 can be configured as a ventilation module to be inserted into or otherwise engaged with a suitably configured opening, such as connection port 3600B in the patient interface 3000. In this form, the ventilation structure may include flanges or similar structures that engage interlockingly with complementary structures in the patient interface or connection port. Pressure-activated seals, such as peripheral sealing flanges, may also be used to facilitate a adequate seal. It should be understood that additional ventilation structures may be present; these may also be configured to be removable or alternatively integrally formed with other components of the patient interface 3000.

[0313] In order to convert the patient interface 3000 to a second-use configuration, such as Figure 3B As shown, the patient removes the tubes 3310 and 3320 of the catheter head cover 3300A from the full face mask 3010. The catheter head cover is then placed to one side, as it is not required in the second use configuration of this example. It is replaced by a positioning and stabilizing structure in the form of a headband arrangement 3300B.

[0314] In the second usage configuration, the air inlet ports 3210 and 3220 of the patient interface are closed to prevent leakage of pressurized air. The air inlet ports 3210 and 3220 can be closed using the ventilation structure 3400 as described above, or sealed with a plug structure 3500 or a stop. The plug structure 3500 can be formed of medical-grade plastic material and can be configured with flanges or similar structures that interlock with complementary structures in the air inlet ports 3210 and 3220. Similar to the ventilation structure, the plug module can be provided with pressure-actuated seals, such as peripheral sealing flanges. In the form incorporating a plug module or stop, air exhaled by the patient can be discharged through a ventilation structure located in another portion of, for example, an integrally formed patient interface 3000.

[0315] In this example of the technology, the full-face mask 3010 is configured with headband attachment points 3350 for the headband 3300B. For example... Figure 3A and Figure 3B As shown, the attachment point can take various forms, including loops, but depending on the configuration of the headband, it can also be a lug or a buckle.

[0316] exist Figure 9Another example of this technology is shown in a second usage configuration of a patient interface in the form of a nose pillow 3030. In this example, a plug structure 3500 is disposed at the end of a headband 3300B for holding the sealing formation structure 3100 in proper position on the patient's face in the second usage configuration. The end of the headband is inserted into the air inlet ports 3210, 3320 of the inflation chamber 3200. Alternatively, Figure 9 The patient interface can be configured for a first use configuration in which the headband 3300B is interchangeably used for the catheter headgear, and the connection port in the front of the inflation chamber (in...) Figure 9 The middle bend (connected to it) is blocked by a plug or venting structure.

[0317] In some examples, the patient interface 3000 may be provided with a pair of head cover attachment points 3350; these masks may be masks with a two-point head cover attachment device. In other examples, the patient interface 3000 may be provided with two pairs of opposing head cover attachment points 3350; these masks may be masks with, for example, Figure 3A and Figure 3B The mask shown is equipped with a four-point headgear attachment device.

[0318] Figure 10 Another example is shown. In this example, the patient interface is in the form of a 3040 oronasal mask. Similar to... Figure 9 For example, in the second usage configuration, the air inlet ports 3210, 3220 of the inflation chamber 3200 are closed by plugs 3500 provided to the ends of the headband 3300B. However, the frame extension 3800 is also provided with arms 3810, which have additional attachment points 3350 at their respective ends. The frame extension 3800 allows the headband 3300B to be used in the form of a four-point headband attachment device, instead of... Figure 9 Two-point headgear attachment device.

[0319] Attached point 3350 is Figure 10 The headband 3300B can be a push-in button, but in other examples it can be a slit through which the strap of the headband 3300B passes and is secured using hook and loop materials. Alternatively, attachment point 3350 can be configured to attach to the headband 3300B via a buckle or clip.

[0320] exist Figure 10In one example, the frame extension 3800 is positioned and held in place by the bend 3610 of the air circuit 4170. However, in some examples, it may be held in place at the front of the inflation chamber 3200 by a snap-fit ​​or other connecting mechanism. In other examples, the frame extension 3800 may be provided with means for adjusting the length of these arms, or alternatively as part of an interchangeable set in which each frame extension has arms of different lengths. This allows the patient to better adjust the force vector applied to the sealing structure when switching from a positioning and stabilizing structure in the form of a catheter headband, if desired.

[0321] In the second usage configuration, the downstream end of the air circuit 4170 is inserted Figure 3A and Figure 3B Full face mask 3010 Figure 9 nose pillow cover or Figure 10 The connection port 3600B is located on the front side of the air chamber 3200 of the mouth and nose mask. This allows the downstream end of the air circuit 4170 to be close to the lower part of the patient's face and neck, a configuration that some patients may prefer for first use.

[0322] This arrangement places the connection port 3600B below the supra-auricular point, close to the patient's face and chin. In some examples, the band 3330 of the positioning and stabilization structure 3300B worn in the second use configuration can be used to seal the air inlet port. In these examples, a portion of the band may include an integrated plug complementary to the air inlet port and configured to connect to the air inlet port during use.

[0323] By swapping the corresponding positioning and stabilizing structures 3300A and 3300B and engaging the air circuit 4170 with the appropriate connection ports 3600A or 3600B respectively, the patient can switch between a first usage configuration and a second usage configuration. Figure 3A and Figure 3B , Figure 9 and Figure 10 The patient interface 3000 is shown in the figure.

[0324] The patient interface can also be interchanged if needed. An advantage of this technology is its relative modularity; by using universal connectors and fittings for the tubing, air inlet port, and connection port of the catheter head, the patient interface can be easily interchanged between, for example, full-face masks, nasal pads, nasal pillows, and nasal masks.

[0325] For some examples of the patient interface 3000, such as full-face or nasal masks, when in the first-use configuration, the lower ends of the tubes 3310, 3320 of the catheter tip can be directly engaged with the inflation chamber 3200, such as... Figure 3A and Figure 3BAs shown. The relative dimensions of these examples of patient interfaces help to provide a sufficiently large area for the tube to engage, while still allowing a large enough area for the connection port to be provided to the front surface of the inflation chamber.

[0326] However, in some other examples of patient interfaces, such as nose pads that typically have an inflation chamber and a relatively small overall surface area, connectors or adapters may be needed to allow the connection of these tubes to facilitate the delivery of pressurized air to the inflation chamber and to seal the structure. In such an example, the tubes engage with an air inlet port in an adapter, which in turn engages with an air inlet port of the inflation chamber 3200.

[0327] 5.2.9.2 Second Example

[0328] Unlike the swapping of positioning and stabilizing structures in the first example, some patients may prefer to simply swap the location of the air circuit relative to the patient interface.

[0329] In the second example of this technique, such as Figure 4A In the first usage configuration shown, the patient interface 3000 includes an inflation chamber 3200 and a sealing-forming structure 3100 in the form of a nasal pad 3020, to which tubes 3310, 3320 are connected. These tubes deliver pressurized air from an air circuit 4170 to the sealing-forming structure 3100, which is connected to a bend in the tube 3610 of a connection port 3600A, which provides access to a catheter tip 3300A forming a positioning and stabilizing structure 3300. Although the example shown illustrates a nasal pad 3020, in other examples, the patient interface may optionally include a full face mask, a nasal mask, or a nasal pillow.

[0330] Tubes 3310 and 3320 are each provided with tabs 3380, which are configured to engage with the carrying strap 3390. The carrying strap 3390 is flexible enough to wrap around the back of the patient's head and rest comfortably against the patient's head, even under tension during use.

[0331] The tab 3380 protrudes from the tube in a generally rearward direction. The tab has a slit therein to receive the end of the strap. The strap can be secured to itself, for example, with a hook-and-loop fastening material after passing through the slit in the tab. Therefore, the strap can be adjusted to fit different head sizes. In some forms of this technology, more than one tab can be provided to offer the patient a range of optional strap placement options. This helps ensure that a proper seal is applied to the face.

[0332] exist Figure 4A and Figure 4BIn the example, tubes 3310 and 3320 are connected to crown connector 3360 at their upper ends. This allows each tube to be removed separately from the others for cleaning or replacement. The connection to the crown connector can be made using... Figure 7 The rigid connector 3370, as previously described with respect to the first example, but other examples of achieving this connection may include interlocking grooves and bolts, snap-lock fittings, threads, etc. In other examples, the catheter head may be Figure 3A As shown in the figure, the catheter head 3300A is an integral structure, in which the left and right catheters 3310 and 3320 meet at their upper ends, where the connection port 3600A can be located.

[0333] The nasal mask 3020 also has a connection port 3600B on its front side, such as... Figure 5A As shown in the enlarged image. Figure 5B As shown, the crown connector 3360 also includes a connection port 3600A. The corresponding connection ports 3600A and 3600B can be configured and arranged with the same or similar engagement mechanisms, such as snap-locking or push-in mating fittings, which complement the fittings provided to the downstream end of the air circuit 4170. This allows the air circuit to be inserted and sealably engaged with one or the other of the two connection ports 3600A and 3600B. Figure 5A and Figure 5B In the examples shown, the engagement mechanisms of connection ports 3600A and 3600B are complementary to the end of bend 3160. In these examples, the downstream end of the air circuit is connected to bend 3160, which in turn inserts into and seals one or the other of the two connection ports 3600A and 3600B.

[0334] When one of the two connection ports 3600A and 3600B receives the air circuit 4170, the other connection port is open. This could impair the delivery of pressurized air to the patient. To prevent this, a ventilation structure 3400 or a plug 3500 is inserted into the open connection port. In one configuration, when one of the two connection ports 3600A and 3600B receives the air circuit 4170, the other connection port is substantially sealed with a closure.

[0335] In the first usage configuration, when the air circuit delivers pressurized air to the patient interface via bend 3610 and tubes 3310, 3320, ventilation structure 3400 or plug 3500 is inserted into connection port 3600B in the inflation chamber 3200 of nasal mask 3020 to ensure minimal or no loss of pressurized air from the patient interface (other than loss through the ventilation structure).

[0336] In the second usage configuration, when the air circuit delivers pressurized air to the patient interface through the nasal mask, the ventilation structure 3400 or plug 3500 is inserted into the connection port 3600A at the coronal connector 3360.

[0337] As previously described, the corresponding connection ports 3600A and 3600B can be configured and arranged with the same engagement mechanism to facilitate connection to the air circuit. In some examples, the ventilation structure or plug is provided with complementary engagement mechanisms. This allows the same ventilation structure 3400 or plug 3500 to be interchangeable between connection ports 3600A and 3600B, advantageously reducing the number of components that need to be manufactured and supplied as part of the patient interface 3000.

[0338] In order to convert the patient interface 3000 into Figure 4B In the second usage configuration shown, the patient simply removes the bend 3610 from the coronal connector 3360 and replaces it with the ventilation structure 3400 or the plug 3500. The bend 3610 then engages with the connection port 3600B of the nasal pad 3020.

[0339] 5.2.9.3 Third Example

[0340] exist Figure 6 In the third example shown, the tubes 3310 and 3320 of the catheter tip 3300A can be engaged with the patient interface 3000 in the form of a nasal pad 3020, allowing these tubes to be rearranged between a first and a second use configuration. This can be advantageous because the patient may not need to completely disengage the air circuit 4170 from the connection port 3600A of the patient interface.

[0341] In this example, when the catheter tip 3300A is... Figure 4A When wearing the first usage configuration shown, in Figure 6 In the second usage configuration shown, the cannula head cover, although still in use for delivering pressurized air to the sealing formation 3100 of the nasal pad 3020, is essentially inverted.

[0342] In this example, the tubes 3310 and 3320 of the catheter head 3300A are engaged with the inflation chamber 3200 in such a way that these tubes can rotate relative to the nose pad 3020 or otherwise rotate.

[0343] For example, in Figure 8AIn this embodiment, the air inlet port of the patient interface may be provided with an adapter 3700 including a rotating ring 3710. The ring is inserted into and locked into the air inlet port of the patient interface via a suitable interlocking mechanism. The adapter includes a bent tube 3722 with a receiving portion 3730 into which the lower end of a connector can be fitted. Once the ring is positioned and locked in place within the air inlet port, the tube can rotate within the ring.

[0344] In another example, Figure 8B In this design, the engagement of the catheter tip tube with the inflation chamber allows for two or more discrete positions to be achieved, for example, by detaching and reattaching the catheter tip tube to the inflation chamber. For instance, the adapter 3700 can be configured as a single-piece bend 3722 having an end configured to insert and lock into an air inlet port provided with a series of axially aligned slots 3742. These slots engage with mating plugs provided on the inner surface of the air inlet port of the patient interface. Other methods of engaging these tubes with the interface are conceivable; for example, the tube may carry a plug and a slotted patient interface. This provides a series of positions for positioning the tube relative to the patient interface. Depending on the desired orientation of the catheter tip, the patient inserts the tube into the patient interface at the desired position, aligning the corresponding interlocking parts. In this example, there may only be two positions, corresponding to two sets of slots / plugs respectively for a "tube-up" configuration and a "tube-down" configuration. However, other positions may be provided in other examples. This can help optimize the fit of the catheter tip when it is worn in a tube-up configuration.

[0345] It should be understood that in this example, the catheter tip 3300A is the primary positioning and stabilizing structure. However, when in the second usage configuration, force is still required to ensure that the seal-forming structure 3100 remains in the proper position on the patient's face. Therefore, when the catheter tip 3300 is in... Figure 6 When the headband is in the inverted position, a second positioning and stabilizing structure in the form of headband arrangement 3300B is required to ensure that the sealing structure 3100 remains in sealed contact with the patient's face.

[0346] The headband arrangement 3300B includes one or more straps 3330 that are worn around the patient's head at the ear points. Figure 3B In contrast to the embodiment of the headband arrangement, in Figure 6 In the middle, the headband arrangement 3300B is attached to the nose pad 3020 only at the two headband connection points 3350.

[0347] In this second usage configuration, the connection port 3600A has been moved from its original position above the supraorbital point to a position below the supraorbital point. In this second usage configuration, the connection port 3600A and the air circuit 4170 are adjacent to the patient's chin and neck.

[0348] 5.2.9.4 Example of a closure

[0349] In the first usage configuration, when the air circuit delivers pressurized air to the patient interface via bend 3610 and tubes 3310, 3320, the connection port 3600B in the inflation chamber 3200 of the nasal mask 3020 is closed (e.g., using ventilation structure 3400, plug structure 3500, or closure 3786) to ensure minimal or no loss of pressurized air from the patient interface (except for loss, if any, that leaves through the ventilation structure).

[0350] In the second usage configuration, when the air circuit delivers pressurized air to the patient interface via the nasal mask, the connection port 3600A at the coronal connector 3360 is closed (e.g., using the ventilation structure 3400, plug structure 3500, or closure 3786) to ensure minimal or no loss of pressurized air from the patient interface (other than loss, if any, from leaving through the ventilation structure).

[0351] As mentioned above, the corresponding connection ports 3600A and 3600B can be configured and arranged with the same or similar engagement mechanisms to facilitate connection to the air circuit.

[0352] These engagement mechanisms (such as snap-lock or push-in fittings) complement the fittings provided to the downstream end of the air circuit 4170, thereby allowing the air circuit to be inserted and sealably engaged with one or the other of the two connection ports 3600A, 3600B. Figure 4A and Figure 4B In the examples shown, the engagement mechanisms of connection ports 3600A and 3600B are complementary to the end of bend 3160. In these examples, the downstream end of the air circuit is connected to bend 3160, which in turn inserts into and seals one or the other of the two connection ports 3600A and 3600B.

[0353] Connection ports 3600A and 3600B may include a closure 3786 covering an opening into which the downstream end of the air circuit can be inserted. This closure may be moved by the patient or by the downstream end (or bend) of the air circuit, allowing it to change from a substantially sealed closed state (in some examples, possibly having some functionality for expelling exhaled carbon dioxide) to an open state, in which pressurized air is delivered to the tube of the catheter head and into the patient's airway. The closure can be configured in various ways.

[0354] exist Figure 11In the first example of the closure 3786 shown in the open state, it can be in the form of a rigid ring 3788 defining a mouth for the closure. This ring is made, for example, of polypropylene, polycarbonate, nylon, etc. In use, the lower portion 3715 of the ring 3788 is arranged within the connection port. The ring 3788 can be a separate structure, such as... Figure 11 As shown, it can be inserted by the patient as needed, or optionally it can be integrated with a connection port (e.g., connection port 3600A, 3600B).

[0355] Surrounding the rigid ring 3788 is a ring 3716, to which the cap closure 3720 is connected via a hinge portion 3789. The hinge portion 3789 may be formed of a soft, deformable plastic material, allowing the closure to be positioned in the closed state. The patient can simply mate the inner surface 3721 of the cap with the rigid ring 3788 of the closure 3786. In some examples, the cap may be a separate structure not connected to the ring. In this example, the ring 3788 may not have the hinge portion 3789. In some examples, the hinge portion 3789 may be removably attached to the cap closure 3720 and / or the ring 3788.

[0356] The cover is provided with multiple orifices; these orifices serve as vents 3799 to expel carbon dioxide exhaled by the patient, but without allowing excessive loss of pressurized air volume. The number and size of the orifices can be varied depending on the required volume of exhaled gas to be expelled. They need to be sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining the therapeutic pressure in the inflation chamber during use.

[0357] Figure 12A and Figure 12B Further examples of a closure 3786 suitable for the present technology, in both a closed and open state, are shown. In this example, the closure 3786 is in the form of an elongated body 3740, which includes at one end an opening 3745 defined by a raised spout 3746. The elongated body 3740 may be formed of, for example, polypropylene, polycarbonate, nylon, etc. The closure 3786 also includes a circular cap closure 3720 having a downwardly extending flange 3747, similarly formed of polypropylene, polycarbonate, nylon, etc. Tracks 3750 or guides may be configured on the sides of the body, and the flange 3747 of the cap engages with the track 3750 or guide. In this example, the patient simply slides the cap along the track to... Figure 12A The closed component is placed in its closed state. Figure 12B The open state shown. The lower side of the cover 3720 (in...) Figure 12A and Figure 12B (Not visible in the middle) may include a silicone layer or the like to help seal the mouth 3745 of the closure 3786.

[0358] Although Figure 12A and Figure 12B The mouth 3745 shown is oriented favorably at one end of the body 3740, but the mouth 3745 could be more centrally oriented. This might require the body itself to be larger to ensure sufficient clearance for the cover 3720 when it slides from the closed to the open position. In some examples, the mouth 3745 could be provided at the center of the body 3740, allowing the cover 3720 to be moved to either side of the mouth 3745. Alternatively, the cover 3720 could be formed of two halves, each favoring one end of the body. The patient slides the two halves together to meet in the mouth.

[0359] In some examples, the end of track 3750 may include a stop in the form of a molded bolt or the like to ensure that the cover 3720 does not become disengaged from the body if it moves too far along track 3750.

[0360] In some examples, the cap 3720 may be provided with multiple orifices arranged and sized for ventilation purposes. In other examples, the raised opening of the ring may form a series of notches extending behind the top surface of the mouth. In this example, although the cap is able to form a seal with the top surface of the mouth, the notches are used to allow exhaled gas to escape. It is understood that the flange of the cap may be arranged to ensure sufficient clearance when the cap moves from a closed to an open state. The size of the notches needs to be sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining therapeutic pressure in the inflation chamber during use.

[0361] exist Figure 11 , Figure 12A and Figure 12B In some examples, the closure 3786 is manipulated by the patient to place it in a desired closed or open state. In some examples, inserting the downstream end of the air circuit into the connection port can move the closure from a closed state to an open state. Figures 13A to 13C An example of this is shown.

[0362] In this example, the closure 3786 is in the form of a ring 3788, such as Figure 13A As best shown, it is either integrally formed with the connection port or as a separate component inserted by the patient. A pair of closure flaps 3760 are arranged inside the ring 3788. These closure flaps are pivotally hinged to a strut 3770 spanning the ring. This strut can be arranged to assist in the direction of pressurized air; for example, the strut can act as a diverter, helping to guide separate flow paths of pressurized air to the left and right tubes of the catheter head. In these examples, the strut can be aligned to optimally achieve this separation of airflow. For example, the strut can be arranged to divide the opening of the closure into a left and right portion, corresponding to the left and right tubes of the catheter head.

[0363] However, in other examples, the closed fold 3760 may be pivotally hinged or otherwise mounted to the periphery of the ring 3788, such as... Figures 14A to 14C As shown. Furthermore, the number of closing flaps can vary. In one example, there can be a single, essentially circular closing flap that is hinged to the periphery of the ring via an edge. In other examples, for example... Figures 14A to 14C The example shown ( Figure 14B and Figure 14C yes Figure 14A The cross-section of the closure element may have four (or more) closure folds 3760, which are arranged equidistantly around the perimeter of the ring 3788.

[0364] In one example, as Figure 14B In the closed state shown, the closure folds 3760 are arranged to provide small slits or gaps 3765 between adjacent folds. These provide some ventilation. The closure folds 3760 can be mounted on a ring 3788, such that the thin portion serves as a hinge 3761, as... Figure 14D As shown, this allows the closed flap to move from the closed state to the open state.

[0365] In such Figure 14C In the open state shown, the closure flap is biased to the open state by the bend 3610 of the air circuit 4170. This creates a channel 3766 therebetween to allow airflow into the left and right tubes of the catheter head at therapeutically effective pneumatic pressure. The flow of pressurized air can be optimized by aligning the channel 3766 created by the open closure flap 3760 with the direction of airflow in the tubes of the catheter head to minimize flow resistance. In another example, the orientation of the channel can be determined relative to one or more of the following: (1) the downstream end of the air circuit ( Figure 14B and Figure 14C (1) the axial direction of the bend in the conduit, (2) the axial direction of the left and right tubes of the conduit head, and (3) the airflow direction in the tube of the conduit head. In another example, the orientation of the baffle can be manually adjusted. For example, ring 3788 can be configured to be rotatable within the connection port to change the axial orientation of the closing baffle 3760.

[0366] exist Figure 13A In this configuration, the closing fold 3760 is arranged such that the closure is in a closed state. For ventilation purposes, in one example, an opening may be provided for the closing fold. Figures 13A to 13C(Not shown in the image). As illustrated in the examples of the aforementioned closures, the number and size of the orifices can vary depending on the required volume of exhaled gas to be expelled. In another example, the closure flaps can be mounted to the rings such that a gap or slit (not shown) exists between adjacent flaps and / or rings 3788 and / or struts 3770. This gap or slit serves as an outlet for exhaled carbon dioxide.

[0367] exist Figure 13B and Figure 13C In the diagram, the interaction between the closing fold 3760 and the downstream end portion of the air circuit (in this example, the bend 3610) can be seen. The orifice of the bend includes an actuation mechanism in the form of a pair of wedges 3780 arranged across the orifice. In this example, the wedges are separated to ensure clearance of the strut 3770 as the bend 3610 advances into the closure 3786. The wedges 3780 rest against the closing fold 3760 and, as the bend 3610 advances further into the closure, pivot about the strut 3770 and bias them from a closed state to an open state, as shown. Figure 13C As shown, this allows pressurized air to pass through and enter the connection port.

[0368] The closed folding plate is installed through its outer edge to, for example... Figures 13A-13C In the example of the ring, the hole of the bend 3610 does not necessarily need to be equipped with a wedge. Instead, the actuation mechanism is the periphery of the hole, which contacts the closing baffle 3760 and biases the closing baffle 3760 to open as the bend advances.

[0369] While the ring 3788 itself can be formed from polypropylene, polycarbonate, nylon, etc., in some examples, the closure flap can be formed from a less rigid plastic material, such as liquid silicone rubber with appropriate Shore hardness. The way the closure flap is attached to the support (or the periphery of the ring) allows the connecting portion of the closure flap to function as a movable hinge. In alternative forms, the closure flap can be more rigid but attached to the support (or the periphery of the ring) via a specific hinge structure.

[0370] Figure 15 Another example is shown where the action of inserting the downstream end of the air circuit into the connection port can move the closure from a closed state to an open state. In this example, the closure is in the form of a ring 3788, as described with respect to the previous example. However, the interior of the closure is spanned by a seal 3790 in the form of a layer of stretchable elastic material, such as rubber or silicone with a suitably low Shore hardness.

[0371] Figure 10The seal 3790 is shown in the closed state. At its center, the seal includes a central orifice 3795. When the downstream end of the air circuit (e.g., a bend) is inserted into the closure 3786, the seal expands and stretches. This increases the overall size of the central orifice 3795 sufficiently to receive the downstream end of the air circuit and / or allow a sufficient amount of pressurized air into the connection port for therapeutic purposes. This biases the closure 3786 from an open state to a closed state. When the downstream end of the circuit is removed, the seal returns to its initial closed state. The stretchable elastic material layer may also include additional vents 3799 around the central orifice 3795 for venting a desired volume of carbon dioxide. However, the size of the central orifice 3795 itself is sufficient for this purpose.

[0372] exist Figures 11 to 15 In the example, in order to transfer patient interface 3000 from Figure 4A The first use configuration is converted to, for example Figure 4B In the second usage configuration shown, the patient simply removes the bend 3610 from the connection port 3600A or the coronal connector 3360 and then engages it with the connection port 3600B of the nasal pad 3020. For this, the patient may need to move the closure 3786 of the nasal pad 3020 from the closed state to the open state. Since the connection port 3600A of the coronal connector 3360 is now open, the closure of the coronal connector needs to be moved from the open state to the closed state. Alternatively, the act of inserting the bend 3610 can adjust the closure from the closed state to the open state. Removing the bend from the connection port allows the closure to self-adjust to the closed state.

[0373] It should be understood that connection ports that can provide patient interfaces may have different types of closures for each port. For example, the connection port 3600A provided to the catheter tip may have a closure such as... Figure 13A-14D The closure described herein, and the connection port 3600B of the inflation chamber is provided with, as described above. Figure 11 and 12A The closure described herein. When the patient interface is worn, the patient may find it easier to manipulate the closure on the inflation chamber than the closure provided to the catheter tip.

[0374] 6. Glossary

[0375] 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.

[0376] 6.1 Overview

[0377] 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.

[0378] Environment: In some forms of this technology, the term environment may have the following meanings: (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0379] Automated positive airway pressure (APAP) therapy: CPAP therapy in which 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: respiratory pressure therapy in which the treatment pressure remains substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In some forms, the pressure will vary between the patient's different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in response to the absence of an indication of partial upper airway obstruction.

[0381] Flow therapy: Breathing therapy involves delivering a controlled flow of air to the inlet of the airway at a rate known as the therapeutic flow, which is generally positive throughout the patient’s respiratory cycle.

[0382] Patient: A person, regardless of whether they have a respiratory illness.

[0383] Pressure: Force per unit area. Pressure can be expressed in units of area, including cmH2O and gf / cm². 2 1000 Pascals. 1 cmH2O equals 1 gf / cm³ 2 And it is approximately 0.98 hPa (1 hPa = 100 Pa = 100 N / m). 2 =1 millibar to 0.001 atmospheres. In this specification, unless otherwise stated, pressure is given in cm H2O.

[0384] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained through the interface pressure Pm at the current moment.

[0385] Respiratory pressure therapy (RPT): Applying an air supply to the airway inlet at a therapeutic pressure that is typically positive relative to the atmosphere.

[0386] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0387] 6.2 Materials

[0388] Silicone or silicone elastomer: Synthetic rubber. In this specification, the reference to silicone refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0389] Polycarbonate: is a thermoplastic polymer of bisphenol A carbonate.

[0390] 6.3 Mechanical properties

[0391] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0392] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain siloxanes and thermoplastic elastomers.

[0393] Hardness: The ability of a material to resist deformation (e.g., described by Young's modulus or by an indentation hardness scale measured on a standardized sample size).

[0394] "Soft" materials can include silicone or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0395] "Hard" materials can include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0396] 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 reciprocal of stiffness is flexibility.

[0397] Flexible structures or components: structures or components that will change shape (e.g., bend) when subjected to a relatively short period of time, such as 1 second, to support their own weight.

[0398] Rigid structures or components: Structures or components that do not substantially change shape when subjected to the loads typically encountered in use. An example of such use could be, for instance, setting up and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway under a pressure of approximately 20 to 30 cmH2O.

[0399] 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 example, the structure or component may be flexible in the first direction and rigid in the second direction.

[0400] 6.4 Facial Anatomy

[0401] Auricle: The entire visible external part of the ear.

[0402] (Nose) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0403] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0404] Frankfurt Plane: A line extending from the lowest point of the eye socket margin to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0405] Lip, lower lip (midpoint of the lower lip):

[0406] Lip, upper (midpoint of upper lip):

[0407] Nostrils (Nares (Nostrils)): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils (nares) is nasal (naris) (nostril). Nostrils are separated by the nasal septum.

[0408] The lowest point on the face where the auricle attaches to the skin.

[0409] The highest point on the face where the auricle attaches to the skin.

[0410] Sagittal plane: A vertical plane running from front to back. The central sagittal plane is the sagittal plane that divides the body into the right and left halves.

[0411] 6.5 Skull Anatomy

[0412] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0413] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0414] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the orbit. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral boundary.

[0415] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary from individual to individual; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0416] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the upper part of the bridge of the nose.

[0417] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval foramen (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0418] The eye socket is the bony cavity in the skull that houses the eyeball.

[0419] Parietal bone: The parietal bone is the top and sides of the skull when joined together.

[0420] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0421] Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the prominent part of the cheek.

[0422] 6.6 Patient Interface

[0423] Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0424] Bend: A bend is an example of a structure that directs the axis of an airflow traveling 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 an approximately 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 removable from the mating component, for example, via a snap-fit ​​connection. In some forms, the bend can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0425] Frame: The frame is generally considered to refer to the mask structure that bears tensile loads between two or more connection points to the hood. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0426] Headgear: A headgear is considered to refer to a form of positioning and stabilization structure designed for use on the head. For example, a headgear may include an assembly of one or more struts, straps, and reinforcements configured to position and hold the patient interface on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, elastic materials, such as laminated composites of foam and fabric. Alternatively, the headband may take the form of one or two gas delivery tubes that may slightly conform to the shape of the head.

[0427] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0428] Inflation chamber: The mask inflation chamber is considered to refer to a portion of the patient interface having walls that at least partially enclose a volume of space, which, in use, contains air pressurized therein to above atmospheric pressure. A housing may form part of the wall of the mask inflation chamber.

[0429] Sealing: can be the noun form of a structure ("seal") or the verb form of the effect ("seal"). Two elements can be constructed and / or arranged to 'seal' or to achieve 'seal' between them, without the need for a separate 'seal' element itself.

[0430] Shell: A shell is considered to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0431] Rotary shaft (noun): A sub-assembly of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotary shaft can be configured to rotate through an angle of at least 360 degrees. In another form, the rotary shaft can be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assembly of the component preferably comprises a pair of mating cylindrical ducts. During use, there can be little or no airflow leakage from the rotary shaft.

[0432] Lacing (noun): A structure used to resist tension.

[0433] Ventilation port (noun): A structure that allows airflow from inside the mask or tubing to ambient air for clinically effective flushing of exhaled gases. For example, clinically effective flushing can involve a flow rate from about 10 liters per minute to about 100 liters per minute, depending on the mask design and treatment pressure.

[0434] 7 Other comments

[0435] This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of this patent document or patent disclosure by any person in the form it appears in the patent office documents or records, but otherwise reserves all copyright rights.

[0436] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other value or intermediate value within the range are broadly included within this technique. The upper and lower limits of these intermediate ranges (which may be independently included in the intermediate range) are also covered within this technique, subject to any specific exclusions within the stated range. Where the range includes one or two limitations, the range excluding any one or both of those included limitations is also included within this technique.

[0437] Furthermore, where one or more values ​​are stated herein as part of the implementation of the technology, it should be understood that, unless otherwise stated, such values ​​may be approximate and may be used with any suitable significant figure to the extent that the actual implementation of the technology may allow or require.

[0438] 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 also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0439] When a particular material is set for use in constructing a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise specified, any and all components described herein should be understood as capable of being manufactured, and therefore can be manufactured together or separately.

[0440] 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.

[0441] 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.

[0442] The terms “comprises” and “comprising” should be understood as referring to each element, component, or step in a non-exclusive manner, indicating the marked element, component, or step that may be present or utilized, or a combination with other unmarked elements, components, or steps.

[0443] The subject headings included in the detailed description are for the reader's convenience only and should not be used to limit the subject matter found throughout the disclosure or claims. Subject headings should not be used to interpret the claims or limit their scope.

[0444] 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 described. 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 shown 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.

[0445] Therefore, it should be understood that numerous modifications can be made to the exemplary examples, and that other arrangements can be designed without departing from the spirit and scope of this technology.

[0446] 8. List of Reference Symbols

[0447]

[0448]

[0449]

Claims

1. A patient interface for delivering a pressurized airflow from an air circuit to an inlet of a patient's airway, the patient interface comprising: Inflation chamber; A sealing structure is provided to the inflation chamber; Multiple connection ports configured to receive airflow from the air circuit and deliver the airflow via the sealing structure to the inlet of the patient's airway, the multiple connection ports including a first connection port and a second connection port; as well as One or more positioning and stabilizing structures are configured to provide, during use, a force that holds the sealing structure in a therapeutically effective position on the patient's head. The patient interface is configured and arranged to be worn by a patient in both a first and a second use configuration. In the first usage configuration, the air circuit is connected to the first connection port, which is configured to be positioned above the patient's supraauricular point during use and fluidly connected to a port on the side of the inflation chamber via first and second gas delivery tubes. The first and second gas delivery tubes are constructed and arranged to contact, during use, a region of the patient's head at least above the patient's supraauricular point to position and stabilize the sealing structure in the effective treatment position. In the second usage configuration, the air circuit is connected to the second connection port and configured to provide airflow to the second connection port, which is positioned in use on the anterior side of the inflation chamber below the patient's supraauricular point. In the second usage configuration, the first and second gas delivery tubes are arranged to contact, during use, a region of the patient's head at least above the patient's supraauricular point to position and stabilize the sealing structure in the effective treatment position. And wherein when the air circuit is connected to the first connection port in the first usage configuration, the second connection port is positioned on the front side of the inflation chamber to receive a ventilation structure or a stop.

2. The patient interface of claim 1, wherein the one or more positioning and stabilizing structures include a first positioning and stabilizing structure.

3. The patient interface of claim 2, wherein the first positioning and stabilization structure is configured to be used with the patient interface in both the first use configuration and the second use configuration.

4. The patient interface of claim 2, wherein the first positioning and stabilizing structure includes first and second gas delivery tubes configured and arranged to contact, in use, at least a region above the patient's ear on the patient's head, wherein portions of the first and second gas delivery tubes configured in use to be positioned above the patient's ear are disposed at the first connection port.

5. The patient interface of claim 1, wherein the air circuit is connected to the second connection port in the second use configuration, the first connection port receiving a ventilation structure or a stop.

6. The patient interface of claim 2, wherein the first connection port is disposed to the first positioning and stabilizing structure, wherein the first connection port is disposed on the portion of the first and second gas delivery tubes configured to be positioned above the patient's supra-auricular point during use.

7. The patient interface of claim 1, wherein the first connection port is disposed on a portion of the first and second gas delivery tubes configured to be positioned above the patient's supra-auricular point during use.

8. The patient interface as claimed in any one of claims 1 to 7, wherein the patient interface further comprises one or more ventilation structures or stops.

9. The patient interface of claim 8, wherein each ventilation structure or stop is configured for connection to the first and / or second connection port.

10. The patient interface of claim 9, wherein in the first usage configuration, the air circuit is connected to the first connection port and one of the one or more ventilation structures or stops is connected to the second connection port, and in the second usage configuration, the air circuit is connected to the second connection port and one of the one or more ventilation structures or stops is connected to the first connection port.

11. The patient interface as claimed in any one of claims 1 to 7, wherein the first connection port and the second connection port are configured to be provided with first and second closures, respectively.

12. The patient interface of claim 11, wherein the first and second closures are configured to move from a closed state to an open state.

13. The patient interface of claim 12, wherein each of the first and second closures includes an opening and at least one closure cover, the closure cover covering at least a portion of the opening when in the closed state.

14. The patient interface of claim 13, wherein each of the first and second closures includes a ring structure surrounding the corresponding opening.

15. The patient interface of claim 14, wherein the at least one closure cap of the first closure and / or the at least one closure cap of the second closure are respectively pivotally hinged to a corresponding one of the ring structures via their outer edges.

16. The patient interface of claim 14, wherein the at least one closure cover of the first closure and / or the at least one closure cover of the second closure are slidably mounted to a corresponding one of the ring structures, wherein each ring structure is provided with a track, and the at least one closure cover is configured to slide along the track.

17. The patient interface of claim 12, wherein the first closure and / or the second closure comprises an opening and at least one closure flap, the closure flap covering at least a portion of the opening when in the closed state, and arranged to be biased from the closed state to the open state through an end of the air circuit.

18. The patient interface of claim 17, wherein the first closure and / or the second closure includes a ring structure surrounding the opening.

19. The patient interface of claim 18, wherein the at least one closure flap of the first closure and the at least one closure flap of the second closure are pivotally hinged to the ring structure via their outer edges.

20. The patient interface of claim 18, wherein the at least one closure flap of the first closure and the at least one closure flap of the second closure are pivotally hinged to a strut spanning an opening of the ring.

21. The patient interface of claim 18, wherein the at least one closing flap of the first closure and the at least one closing flap of the second closure span a corresponding opening or ring structure and are provided with a central orifice, the size of which increases when the first closure and / or the second closure is biased from the closed state to the open state by the end of the air circuit.

22. The patient interface of claim 17, wherein the end of the air circuit includes an actuation mechanism arranged to act on the first closure and the second closure.

23. The patient interface of claim 11, wherein the first closure and / or the second closure includes a vent.

24. The patient interface of claim 23, wherein the vent is in the form of one or more openings provided on the at least one closure cover of the first closure and / or the at least one closure cover of the second closure.

25. The patient interface of claim 23, wherein the at least one closure cover of the first closure and / or the at least one closure cover of the second closure comprises two or more closure flaps, and wherein the vent is in the form of a slit formed by the distance between adjacent closure flaps.

26. The patient interface of claim 23, wherein the at least one closure cover of the first closure and / or the at least one closure cover of the second closure comprises four closure flaps attached to the inner surface of a corresponding one of the first closure or the second closure, and wherein the vent is in the form of two intersecting slits formed by the distance between adjacent closure flaps.

27. The patient interface of claim 11, wherein when in the open state, the first closure and the second closure are configured to allow the airflow to be delivered to the inlet of the patient's airway. When in the first usage configuration, the first closure of the first connection port is in the open state and the second closure of the second connection port is in the closed state. When in the second usage configuration, the first closure of the first connection port is in the closed state, and the second closure of the second connection port is in the open state.

28. The patient interface of any one of claims 1 to 7, wherein the patient interface comprises more than one air chamber, wherein each air chamber is configured to be interchangeably included as part of the patient interface.

29. The patient interface of any one of claims 1 to 7, wherein the patient interface comprises more than one sealing formation, wherein each sealing formation is configured to be interchangeably included as part of the patient interface.

30. The patient interface as described in claim 29, wherein, The patient interface includes a plurality of single-inflation chambers, wherein each inflation chamber is configured to be interchangeably included as part of the patient interface, and The plurality of the aforementioned inflatable chambers and / or sealing structures are configured as one or more of the following: a nose mask, a nose pad, a nose pillow, or a full-face mask.

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