Fabric catheter with window

Abstract

A patient interface positioning and stabilizing structure includes a gas delivery tube having a tube wall with an internal passage for a flow of pressurized air. A portion of the tube wall includes a patient-contacting portion and a non-patient-contacting portion. The patient contact includes a layer of fabric material or foam material configured to rest on the head of the patient. At least one section of the non-patient-contacting portion comprises a transparent and / or translucent material. A layer of textile material or foam material is bonded to the transparent and / or translucent material such that the tube wall is formed in a one-piece configuration. A plane extending generally transverse to the longitudinal axis comprises both (1) a layer of textile material or foam material and (2) a transparent and / or translucent material such that a patient can view the internal passage along the transverse axis extending through the plane.

Description

[0001] Divisional application statement

[0002] This application is a divisional application of Chinese invention patent application filed on October 30, 2020, entitled "Fabric Conduit with Window", with application number 2020800766902.

[0003] This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of these patent documents or patent disclosures by any person in the form they appear in the patent office documents or records, but otherwise reserves all copyright rights.

[0004] Cross-references to related applications

[0005] This application claims the benefit of Australian Provisional Patent Application No. 2019902272, filed on October 31, 2019, the entire contents of which are incorporated herein by reference. Background Technology 2.1 Technical Field

[0007] This technology relates to one or more of the following: detection, diagnosis, treatment, prevention, and improvement of respiratory-related conditions. This technology also relates to medical devices or equipment and their uses.

[0008] 2.2 Description of relevant technologies

[0009] 2.2.1 The human respiratory system and its disorders

[0010] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0011] 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 enter the venous blood from inhaled air and carbon dioxide to be expelled in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the airway tubes and 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.

[0012] A range of breathing disorders exist. Some conditions may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0013] 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.

[0014] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. The condition causes the affected patient to stop breathing, typically for periods ranging from 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can contribute to cardiovascular disease and brain damage. Concomitant symptoms are common, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0015] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a dysregulation of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Due to the repetitive hypoxia, CSR can be harmful. In some patients, CSR is associated with repetitive awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0016] Respiratory failure is a term for a respiratory disorder in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can encompass some or all of the following disorders.

[0017] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0018] 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.

[0019] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These diseases include increased airflow resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0020] Neuromuscular disease (NMD) is a broad term encompassing many diseases and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0021] The chest wall is 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.

[0022] A range of treatments have been used to treat or improve these symptoms. Furthermore, other healthy individuals may utilize these treatments to prevent respiratory distress. However, these treatments have many drawbacks.

[0023] 2.2.2 Treatment

[0024] Various treatments, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), and invasive ventilation (IV), have been used to treat one or more of the above-mentioned respiratory disorders.

[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 help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-invasive respiratory disease (NMD), and chest wall disorders. 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] 2.2.3 Treatment System

[0029] These therapies can be provided by treatment systems or devices. Such systems and devices can also be used to diagnose conditions without treating them.

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

[0031] 2.2.3.1 Patient Interface

[0032] A patient interface can be used to attach a breathing device to its wearer, for example, by providing an airflow into the airway. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to deliver gas at a positive pressure of approximately 10 cmH2O into the airway.

[0033] 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 may be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient.

[0034] Some masks may be clinically disadvantageous for this technique, such as those that block airflow through the nose and only allow it through the mouth.

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

[0036] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0037] The design of the patient interface presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head comprises bones, cartilage, and soft tissues, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during respiratory therapy sessions.

[0038] Due to these challenges, some masks suffer from one or more of the following problems: obtrusive, unattractive, expensive, mismatched, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. Wrongly sized masks can lead to decreased compliance, reduced comfort, and adverse patient outcomes. Masks designed solely for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for administering anesthetics are acceptable for their original purpose, but are not ideally comfortable for prolonged wear (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.

[0039] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing difficulties. Patients may not adhere to treatment if the mask is uncomfortable or difficult to use. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may be unable to clean it, which could affect adherence.

[0040] While masks designed for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0041] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0042] 2.2.3.1.1 Sealing Formation Structure

[0043] Patient interfaces may include seal-forming structures. Because they come into direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0044] The patient interface can be partially characterized based on the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part and a second sub-part, the first sub-part forming a seal around the left nostril and the second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils during use. This single element may be designed, for example, to cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0045] A sealing structure that works effectively in one area of ​​a patient's face may not be suitable for another, for example, because the shape, structure, variability, and sensitive areas of a patient's face differ. For instance, a seal on swimming goggles that cover a patient's forehead may not be suitable for use on a patient's nose.

[0046] Certain seal-forming structures can be designed for mass production, making a design suitable, comfortable, and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0047] 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 and the seal-forming portion engages face-to-face with the patient's face. The seal-forming structure may include an air- or fluid-filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer (e.g., rubber). With this type of seal-forming 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.

[0048] 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 inside 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.

[0049] Another type of seal-forming structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0050] 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.

[0051] 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; and WO 2010 / 135,785.

[0052] One form of nasal pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0053] ResMed has manufactured the following products incorporating nasal pillows: SWIFT™ Nasal Pillow Mask, SWIFT™ II Nasal Pillow Mask, SWIFT™ LT Nasal Pillow Mask, SWIFT™ FX Nasal Pillow Mask, and MIRAGE LIBERTY™ Full Face Mask. The following patent application assigned to ResMed describes an example of a nasal pillow mask: International Patent Application WO2004 / 073,778 (which describes ResMed's SWIFT...). TM Other aspects of the nose pillow), U.S. Patent Application 2009 / 0044808 (which describes ResMed SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe ResMed's MIRAGE LIBERTY) TM (Regarding full-face masks); International Patent Application WO 2009 / 052,560 (which describes ResMed's SWIFT...) TM Other aspects of the FX nose pillow).

[0054] 2.2.3.1.2 Positioning and Stability

[0055] The sealing structure of the patient interface used in positive pressure therapy is subject to the corresponding force of the air pressure that would disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain it in a sealed relationship with the appropriate part of the face.

[0056] One technique involves using adhesives. See, for example, U.S. Patent Application Publication US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0057] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following problems: unsuitability, bulkiness, discomfort, and inconvenience of use.

[0058] 2.2.3.1.3 Pressurized air duct

[0059] In one type of treatment system, pressurized airflow is supplied to the patient interface via a conduit in an air circuit fluidly connected to the patient interface, such that the conduit extends forward from the patient's face when the patient interface is positioned over the patient's face during use. This can sometimes be referred to as an "elephant trunk" type interface.

[0060] Some patients find the interface unsightly and are therefore reluctant to wear it, thus reducing patient compliance. Furthermore, the catheter connected to the interface in front of the patient's face can easily get tangled in bedding.

[0061] 2.2.3.1.4 Pressurized air ducts used for positioning / stabilizing the sealing structure

[0062] Alternative types of treatment systems seeking to address these problems include patient interfaces in which the tubing that delivers pressurized air to the patient's airway also serves as part of the structure to position and stabilize a sealed portion of the patient interface to the appropriate part of the patient's face, also known as a "headband." This type of patient interface may be referred to as a combination of a 'headband tube' or a 'catheter headband.' Such a patient interface allows a catheter in the air circuit providing a flow of pressurized air 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. One example of such a treatment system disclosed in U.S. Patent Publication 2007 / 0246043, the contents of which are incorporated herein by reference, involves a catheter connected to the tubing in the patient interface via a port positioned on the top of the patient's head during use.

[0063] The Philips DreamWear™ face mask includes a headband tube. The length of the DreamWear™ headband tube is not adjustable. Therefore, three different sizes of DreamWear™ headbands are offered to accommodate patients with different face sizes. Offering more different sizes increases the complexity and cost of manufacturing the headbands and can result in larger packages. 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 “perfect” fit.

[0064] Patient interfaces with headbands offer several advantages, such as avoiding the need for catheters that connect to the patient's face in front, which can be unsightly and protruding. Furthermore, patient interfaces with headbands allow for extended wear while the patient sleeps, creating an effective seal against the face and enhancing patient comfort.

[0065] 2.2.3.2 Respiratory Pressure Therapy (RPT) Equipment

[0066] Respiratory pressure therapy (RPT) devices can be used to deliver one or more of the aforementioned treatments, for example, by generating an airflow for delivery to the airway inlet. This airflow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0067] Pneumatic generators are known in 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 use may suffer from drawbacks related to one or more of comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0068] This provides device designers with countless options. Design standards often conflict, meaning that some design choices deviate from the norm or are unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to minute variations in one or more parameters.

[0069] 2.2.3.3 Humidifier

[0070] Delivering an unhumidified airflow can lead to airway dryness. Using a humidifier with an RPT device and patient interface to generate humidified gas minimizes dryness of the nasal mucosa and increases patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air.

[0071] Many artificial humidification devices and systems are known, however, they do not meet the specific requirements of medical humidifiers.

[0072] Medical humidifiers are used to increase the humidity, temperature (or both) of an airflow relative to ambient air, typically when the patient is asleep or resting (e.g., in a hospital). Bedside medical humidifiers can be small. Medical humidifiers can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (e.g., saunas, air conditioners, evaporative coolers, etc.) can also humidify the air inhaled by the patient; however, these systems also humidify and / or heat the entire room, which can make the occupant uncomfortable. Furthermore, medical humidifiers can have more stringent safety constraints than industrial humidifiers.

[0073] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide insufficient humidification, and some may be difficult or inconvenient for patients to use.

[0074] 2.2.3.4 Ventilation port technology

[0075] Some forms of therapeutic systems may include vents to allow the flushing of exhaled carbon dioxide. Vents allow gas to flow from the internal space of the patient interface (e.g., a pressurization chamber) to the external space of the patient interface, such as into the environment.

[0076] The vent may include an opening through which gas can flow during mask use. Many such vents are noisy. Others may become blocked during use, thus providing insufficient flushing. Some vents can, for example, disturb the sleep of the patient's bed partner by causing noise or congested airflow. Summary of the Invention

[0077] This technology relates to providing medical devices for diagnosing, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0078] The first aspect of this technology relates to devices for diagnosing, improving, treating, or preventing respiratory disorders.

[0079] Another aspect of this technology relates to methods for diagnosing, improving, treating, or preventing respiratory disorders.

[0080] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0081] One aspect of this technology includes a patient interface for delivering a supply of pressurized breathable gas to the inlet of a patient's airway.

[0082] Another aspect of this technology relates to a patient interface including a sealing-forming structure configured and arranged to form a seal with an area of ​​the patient's face surrounding an inlet to the patient's airway, for sealing and delivering a pressurized airflow at a therapeutic pressure at least 6 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle during use; a pressurization chamber capable of being pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure; and a positioning and stabilizing structure providing forces to hold the sealing-forming structure in a therapeutically effective position on the patient's head.

[0083] Another aspect of this technology relates to a patient interface comprising: an air delivery chamber; a sealing formation; an air vent structure; and a positioning and stabilizing structure that provides forces to hold the sealing formation in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes at least one gas delivery tube to receive an airflow from a connection port and deliver the airflow via the sealing formation to an inlet of the patient's airway. The gas delivery tube is configured and arranged to contact, in use, a region of the patient's head at least above an ear-based point.

[0084] According to one aspect of the present technology, there is a positioning and stabilizing structure that provides forces to hold a sealing-forming structure in a therapeutically effective position on a patient's head. The sealing-forming structure is configured and arranged to form a seal around the inlet of the patient's airway in the area of ​​the patient's face for sealing and delivering an airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use. The positioning and stabilizing structure includes:

[0085] At least one gas delivery tube receives the airflow from a connection port at the top of the patient's head and delivers the airflow to the inlet of the patient's airway via the sealing structure. The gas delivery tube is configured and arranged to contact, in use, a region of the patient's head at least above the supraaural base of the patient's head. The gas delivery tube includes a tube wall defining a hollow interior through which air can flow to the sealing structure. The tube wall includes:

[0086] The patient contact area includes a first outer layer comprising a fabric or foam material configured to rest against the patient's head during use; and

[0087] The non-patient contact portion includes a second outer layer comprising a fabric or foam material on the side of the gas delivery tube opposite to the first outer layer.

[0088] According to one aspect of the present technology, there is a positioning and stabilizing structure that provides forces to hold a sealing-forming structure in a therapeutically effective position on a patient's head. The sealing-forming structure is configured and arranged to form a seal around the inlet of the patient's airway in the area of ​​the patient's face for sealing and delivering an airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use. The positioning and stabilizing structure includes:

[0089] At least one gas delivery tube receives the airflow from a connection port at the top of the patient's head and delivers the airflow to the inlet of the patient's airway via the sealing structure. The gas delivery tube is configured and arranged to contact, in use, a region of the patient's head at least above the supraaural base of the patient's head. The gas delivery tube includes a tube wall defining a hollow interior through which air can flow to the sealing structure, wherein at least a portion of the tube wall includes:

[0090] A patient contact portion comprising a fabric or foam layer configured to rest against the patient's head during use; and

[0091] A non-patient contact portion, wherein at least one section of the non-patient contact portion is made of a transparent material.

[0092] According to one aspect of this technology, the patient interface includes:

[0093] A sealing-forming structure is constructed and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, so as to deliver a pressurized airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use.

[0094] A pressurization chamber, capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure.

[0095] A positioning and stabilizing structure provides forces to hold a sealing-forming structure in a therapeutically effective position on a patient's head, the sealing-forming structure being configured and arranged to form a seal around an inlet to the patient's airway in a region of the patient's face for sealing and delivering an airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use, the positioning and stabilizing structure comprising:

[0096] At least one gas delivery tube, coupled to the pressurization chamber and configured to receive a pressurized airflow from a connection port on the top of the patient's head and deliver the pressurized airflow through the pressurization chamber to the inlet of the patient's airway, the at least one gas delivery tube being constructed and arranged to contact at least one region of the patient's head above an ear-base point during use, the at least one gas delivery tube including a tube wall having an internal passage for allowing pressurized air to flow along the longitudinal axis of the tube to the sealing structure, wherein at least a portion of the tube wall includes:

[0097] The patient contact portion includes a first outer layer comprising a fabric or foam material configured to rest against the patient's head during use; and

[0098] A non-patient contact portion, wherein at least one section of the non-patient contact portion is made of a transparent and / or translucent material to allow the channel to be observed from the outside;

[0099] The fabric material layer is bonded to the transparent and / or translucent material, such that the tube wall is formed as a single piece; and

[0100] The plane, which extends approximately transversely to the longitudinal axis, contains (1) a fabric or foam material and (2) a transparent and / or translucent material, allowing the patient to observe the passage along the transverse axis extending through the plane.

[0101] In the examples, the patient contact portion may include more than one layer. In these examples, the patient contact portion may include an outer layer of fabric or foam material configured to rest against the patient's head in use; and at least a first inner layer of thermoplastic material forming at least a portion of the air path within the at least one gas delivery conduit. The first inner layer is bonded to the outer layer.

[0102] In the examples, the patient contact portion comprises a single layer of fabric material or foam material. In these examples, (a) the material properties of the fabric material or foam material are impermeable; and / or (b) the fabric material or foam material is coated with an impermeable substance along at least one surface, the at least one surface forming the inner surface of the at least one gas delivery tube, the inner surface being configured to contact the pressurized gas flow.

[0103] In the example, the fabric or foam material may comprise: (a) a blend of polyamides, such as nylon, polyester, and / or spandex; and (b) a laminate of a blend of polyamides, such as nylon, polyester, and / or spandex, and one or more siloxanes. In this example, the thickness of each silicone laminate may be between 5 and 75 micrometers. In another example, each silicone laminate may be 20 to 30 micrometers thick, preferably 25 micrometers thick.

[0104] In the examples, the patient contact area may include segments of transparent and / or translucent material, wherein a portion of the transparent and / or translucent material segment is configured to receive a fabric material or foam material. In these examples, segments of transparent and / or translucent material in non-patient contact areas may include an adhesive layer configured to bond to a fabric material or foam material.

[0105] In the example, the non-patient contact portion may include a segment configured to receive the transparent and / or translucent material segment. In this example of the technology, the fabric or foam material of the non-patient contact portion may include: (a) an adhesive layer configured to bond to the transparent and / or translucent material segment; or (b) a hook-and-loop material layer configured to cooperatively bond with a complementary layer of hook-and-loop material bonded to the transparent and / or translucent material segment.

[0106] In the example, one of the patient contact portion or the non-patient contact portion is configured to receive: (a) an adhesive layer to which the other of the patient contact portion or the non-patient contact portion may be bonded; or (b) a hook and loop material layer configured to cooperatively bond with a complementary layer of hook and loop material bonded to the other of the patient contact portion or the non-patient contact portion.

[0107] In the examples, the non-patient contact portion may include two or more layers. In these examples, the non-patient contact portion may include an outer layer of transparent and / or translucent material and a first inner layer of at least thermoplastic material, the first inner layer defining at least a portion of an air path within at least one gas delivery conduit.

[0108] In the example, at least a portion of the transparent and / or translucent material segment: (a) is configured as a rigid element; and / or (b) includes an accordion-like segment; and / or (c) includes a series of corrugations. In this example, (a) a fabric or foam material is overmolded onto the accordion-like segment; (b) the fabric or foam material is located on the patient contact area and is configured to contact the patient; and / or (c) the fabric or foam material is on the non-patient contact area.

[0109] In one example of this technology, segments of transparent and / or translucent material may substantially extend the length of at least one gas delivery tube. In another example of this technology, segments of transparent and / or translucent material may extend a portion of the length of at least one gas delivery tube. In yet another example of this technology, transparent and / or translucent material may be arranged in discrete segments along the length of at least one gas delivery tube, each segment being separated by segments of opaque and / or translucent material (e.g., fabric or foam material).

[0110] In one example, the patient contact portion and the non-patient contact portion may each be elongated and each include sides facing forward (in front of at least one gas delivery tube during use) and rearward (behind at least one gas delivery tube during use), respectively. The front and rear sides of the patient contact portion and the non-patient contact portion are connected along the length of at least one gas delivery tube. In this example, at least one or both sides of the front and rear sides of the non-patient contact side are made of transparent and / or translucent material.

[0111] In this example, the front side of the non-patient contact may have a different stiffness than the rear side; (a) the front side of the non-patient contact may have a greater stiffness than the rear side of the non-patient contact; (b) the front side and / or the rear side of the non-patient contact may have a stiffness that varies along the length of at least one gas delivery tube; (c) the stiffness of the front side and / or the rear side of the non-patient contact at the lower part of the at least one gas delivery tube may be greater than the stiffness at the upper part of the at least one gas delivery tube.

[0112] In the example, the transparent and / or translucent material segments of the second outer layer may be formed of an elastomer, wherein the elastomer is one or more of the following: a) silicone; b) thermoplastic elastomer; or c) thermoplastic polyurethane (TPU).

[0113] In further examples: (a) the patient contact portion and / or the non-patient contact portion may be thermoformed; (b) at least one gas delivery tube may include a substantially D-shaped cross-section; (c) at least one gas delivery tube may include a generally rectangular cross-section having two or more rounded corners; (d) the width of at least one gas delivery tube may vary between 34 mm and 18 mm along the length of at least one gas delivery tube; (e) the height of at least one gas delivery tube may vary between 8 mm and 6 mm along the length of at least one gas delivery tube; and / or (f) the non-patient contact portion comprises only transparent material. In these examples, (i) the D-shaped cross-section includes a generally flat surface and an arcuate surface, the flat surface forming the patient contact portion and the arcuate surface forming the non-patient contact portion; (ii) the arcuate surface includes a first segment and a second segment, the first segment being constructed of a transparent and / or translucent material and the second segment being constructed of a fabric or foam material; and / or (iii) the first segment is directly coupled to the flat surface, and the second segment is positioned opposite the flat surface.

[0114] In examples, the manufacturing method includes positioning a fabric material or a foam material in a mold; introducing the transparent and / or translucent material into the mold; bonding the transparent and / or translucent material to the fabric material and / or the foam material to form the at least one gas delivery tube; and connecting the at least one gas delivery tube to the pressurization chamber and / or the sealing formation structure. In these examples, (a) the mold includes a semi-circular protrusion, and the transparent and / or translucent material flows around the semi-circular protrusion and forms a semi-circular recess along the hollow interior; and / or (b) the semi-circular protrusion guides the transparent and / or translucent material to the fabric material or the foam material to allow bonding between the transparent and / or translucent material and the fabric material or the foam material prior to forming the non-patient contact portion.

[0115] According to one aspect of the present technology, there is a positioning and stabilizing structure that provides forces to hold a sealing-forming structure in a therapeutically effective position on a patient's head. The sealing-forming structure is configured and arranged to form a seal around the inlet of the patient's airway in the area of ​​the patient's face for sealing and delivering an airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use. The positioning and stabilizing structure includes:

[0116] At least one gas delivery tube receives the airflow from a connection port at the top of the patient's head and delivers the airflow to the inlet of the patient's airway via the sealing structure. The at least one gas delivery tube is configured and arranged to contact, in use, a region of the patient's head at least above the supraacus aponeurosis. The at least one gas delivery tube includes a tube wall defining a hollow interior through which air can flow to the sealing structure, and at least a portion of the tube wall comprises:

[0117] A patient contact portion comprising a fabric material layer or a foam material outer layer configured to rest against the patient's head during use; and

[0118] Non-patient contact area, which includes at least a section of transparent material;

[0119] A rigid element, wherein the rigid element is a segment of transparent material. In one example, the transparent material of the non-patient contact portion may be an elastomer, wherein the elastomer is one or more of the following: a) silicone; sb) thermoplastic elastomer; or c) thermoplastic polyurethane (TPU).

[0120] In one example of this technology, the transparent section may substantially extend the length of at least one gas delivery pipe. In another example of this technology, the transparent section extends a portion of the length of at least one gas delivery pipe. In yet another example of this technology, the transparent sections are arranged at regular intervals along the length of at least one gas delivery pipe.

[0121] In one example, the patient contact portion and the non-patient contact portion may each be elongated and each include sides facing forward (in front of at least one gas delivery tube during use) and rearward (behind at least one gas delivery tube during use), respectively. The front and rear sides of the patient contact portion and the non-patient contact portion are connected along the length of at least one gas delivery tube. In this example, at least one or both sides of the front and rear sides of the non-patient contact side are made of a transparent material.

[0122] In one example, a rigid element may be provided on one of the front edge and the rear side of at least one gas delivery pipe.

[0123] In this example, the front side of at least one gas delivery pipe may have a different stiffness than the rear side of at least one gas delivery pipe; (a) the front side of at least one gas delivery pipe may have a greater stiffness than the rear side of at least one gas delivery pipe; (b) the front side of at least one gas delivery pipe and / or the rear side of at least one gas delivery pipe may have a stiffness that varies along the length of at least one gas delivery pipe; (c) the stiffness of the front side of at least one gas delivery pipe and / or the rear side of at least one gas delivery pipe at the lower part of at least one gas delivery pipe may be greater than the stiffness at the upper part of at least one gas delivery pipe.

[0124] In the examples, the rigid element is formed by: a) the thickness of the transparent material segment being greater at a first portion of at least one gas delivery pipe than at a second portion of at least one gas delivery pipe; and b) the width of the transparent material segment being greater at the first portion of at least one gas delivery pipe than at the second portion of at least one gas delivery pipe. In these examples, the first portion is the lower part of at least one gas delivery pipe, and the second portion is the upper part of at least one gas delivery pipe. In other examples, the first portion is the upper part of at least one gas delivery pipe, and the second portion is the lower part of at least one gas delivery pipe. In further examples, the first portion is the front side of at least one gas delivery pipe, and the second portion is the rear side of at least one gas delivery pipe, or the first portion is the rear part of at least one gas delivery pipe, and the second portion is the front part of at least one gas delivery pipe.

[0125] In the examples, the non-patient contact side includes a front side and a rear side, which are configured to face forward and backward, respectively, during use. In these examples, (a) both the front and rear sides are made of transparent and / or translucent material; and / or (b) the lateral axis extends generally from the front to the rear and includes only the transparent and / or translucent material.

[0126] In the example, at least one gas delivery tube is selectively connected to the pressurization chamber and is configured to be removed to allow the patient to clean the inside of the tube.

[0127] According to another aspect of the present technology, there is a positioning and stabilizing structure that provides force to hold the sealing-forming structure in a therapeutically effective position on the patient's head. The sealing-forming structure is configured and arranged to form a seal around the inlet of the patient's airway in the area of ​​the patient's face for sealing and delivering an airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use. The positioning and stabilizing structure includes:

[0128] At least one gas delivery tube receives the airflow from a connection port at the top of the patient's head and delivers the airflow to the inlet of the patient's airway via the sealing structure. The at least one gas delivery tube is configured and arranged to contact, in use, a region of the patient's head at least above the supraaural base. The at least one gas delivery tube includes a tube wall defining a hollow interior through which air can flow to the sealing structure. In use, the at least one gas delivery tube includes:

[0129] Upper and lower pipe sections

[0130] The upper tube wall includes a patient contact portion containing an elastomer and a non-patient contact portion containing an elastomer.

[0131] Furthermore, the lower tube wall includes a patient contact portion and a non-patient contact portion. The patient contact portion includes a first layer of fabric or foam material configured to rest against the patient's head during use. The non-patient contact portion includes a second outer layer, wherein at least a portion of the second outer layer is made of a transparent material.

[0132] In the example, the first layer of the fabric material is one or more of the following fabric materials: a) nylon; b) polyester; c) spandex.

[0133] In the example, the first layer of fabric material a) is bonded to the second outer layer by an adhesive; b) is bonded to the second outer layer by a hook and loop material.

[0134] In one example, the first layer of fabric material is also provided to the upper tube.

[0135] In one example, the transparent material of the second outer layer may be an elastomer, wherein the elastomer is one or more of the following: a) silicone; sb) thermoplastic elastomer; or c) thermoplastic polyurethane (TPU).

[0136] According to one aspect of the present technology, a patient interface is provided, which includes...

[0137] A pressurization chamber, capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the pressurization chamber including a pressurization chamber inlet port, the size and structure of which are configured to receive airflow for patient respiration at the treatment pressure.

[0138] A sealing structure is configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet. The sealing structure has an opening therein, allowing airflow at the therapeutic pressure to be delivered at least to the inlet of the patient's nostrils. The sealing structure is configured and arranged to maintain the therapeutic pressure in the pressurization chamber throughout the patient's respiratory cycle during use.

[0139] Based on the positioning and stable structure of any of the above aspects; and

[0140] A ventilation structure configured to allow continuous flow of exhaled air from the interior of the pressurization chamber to the surrounding environment, the size and shape of which are set to maintain therapeutic pressure in the pressurization chamber during use.

[0141] The patient interface is configured to allow the patient to breathe from the environment through their mouth without pressurized airflow passing through the inlet port of the pressurization chamber, or the patient interface is configured not to cover the patient's mouth.

[0142] Another aspect of certain forms of this technology is a system for treating respiratory disorders, which includes a patient interface, an air circuit, and a positive pressure air source according to any one or more other aspects of this technology.

[0143] According to one aspect of the present technology, there is a method for manufacturing a positioning and stabilizing structure, providing forces to hold the sealing-forming structure in a therapeutically effective position on a patient's head. The sealing-forming structure is configured and arranged to form a seal around the inlet of the patient's airway in a region of the patient's face for sealing and delivering an airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use. The positioning and stabilizing structure includes:

[0144] At least one gas delivery tube receives the airflow from a connection port at the top of the patient's head and delivers the airflow to the inlet of the patient's airway via the sealing structure. The gas delivery tube is configured and arranged to contact, in use, a region of the patient's head at least above the supraaural base of the patient's head. The gas delivery tube includes a tube wall defining a hollow interior through which air can flow to the sealing structure, wherein at least a portion of the tube wall includes:

[0145] A patient contact portion comprising a fabric material layer or a foam material outer layer configured to rest against the patient's head during use; and

[0146] A non-patient contact portion, wherein at least one section of the non-patient contact portion is made of a transparent material.

[0147] Another aspect of this technology is a patient interface, which is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0148] One aspect of this technology is a method for manufacturing equipment.

[0149] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for people without medical training, those who are clumsy, have limited vision, or have limited experience in using this type of medical device.

[0150] One aspect of this technology is a portable RPT device that can be carried by a person (e.g., a person in their household).

[0151] 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.

[0152] According to one aspect of this technology, the patient interface includes:

[0153] A sealing-forming structure is constructed and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, so as to deliver a pressurized airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use.

[0154] A pressurization chamber, capable of being pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure.

[0155] And positioning and stabilizing structures that provide the force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0156] According to one aspect of the present technology, at least one gas delivery tube is coupled to the pressurization chamber and configured to receive a flow of pressurized air from a connection port on the top of the patient's head and deliver the pressurized air flow through the pressurization chamber to an inlet of the patient's airway, the at least one gas delivery tube being constructed and arranged to contact at least one region of the patient's head above an ear-base point during use, the at least one gas delivery tube including a tube wall having an internal passage for allowing pressurized air to flow along the longitudinal axis of the tube to the sealing structure, wherein at least a portion of the tube wall includes:

[0157] A patient contact portion comprising a fabric or foam layer configured to rest against the patient's head during use; and

[0158] A non-patient contact portion, wherein at least one section of the non-patient contact portion is made of a transparent and / or translucent material to allow the channel to be observed from the outside;

[0159] The fabric material layer is bonded to the transparent and / or translucent material, such that the tube wall is formed as a single piece; and

[0160] The plane, which extends approximately transversely to the longitudinal axis, contains (1) a fabric or foam material and (2) a transparent and / or translucent material, allowing the patient to observe the passage along the transverse axis extending through the plane.

[0161] Of course, some of these aspects can form sub-aspects of this technology. 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.

[0162] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description

[0163] This technology is illustrated by way of example and not limitation in the figures, and similar reference numerals in the figures refer to similar elements, including:

[0164] 4.1 Treatment System

[0165] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient sleeps in a supine position.

[0166] Figure 1BA system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0167] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying position.

[0168] 4.2 Respiratory System and Facial Anatomy

[0169] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0170] Figure 2B It is a front view of the face with several marked surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0171] Figure 2C It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal septum, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, supraauricular base, and subauricular base. The vertical and anteroposterior directions are also marked.

[0172] Figure 2D This is another side view of the head. The approximate locations of the Frankfurt plane and the nasolabial angle are indicated. The coronal plane is also shown.

[0173] 3.3 Patient Interface

[0174] Figure 3 A patient interface in the form of a nasal mask and catheter headband according to the present technology is shown.

[0175] Figure 4 Another form of catheter headband according to this technology is shown.

[0176] Figure 5 A cross-sectional view of an example of a gas delivery pipe according to the present technology is shown.

[0177] Figure 6 It shows Figure 5 A perspective view of the gas delivery pipe.

[0178] Figure 7 An end view of another example of a gas delivery pipe according to this technology is shown.

[0179] Figure 8 A side view of another example of a gas delivery pipe according to this technology is shown.

[0180] Figure 9 A perspective view of the lower part of another form of gas delivery pipe according to the present technology is shown.

[0181] Figure 10 A front view of one form of a catheter headband according to this technology is shown.

[0182] Figure 11 A perspective view of the upper part of another form of gas delivery pipe according to the present technology is shown.

[0183] Figure 12 It shows Figure 11 A perspective view of the lower part of the gas delivery pipe. Detailed Implementation

[0184] 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.

[0185] 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.

[0186] 5.1 Treatment

[0187] In one form, the technology includes a method for treating respiratory disorders, the method comprising the step of applying positive pressure to the airway inlet of a patient 1000.

[0188] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0189] In some examples of this technique, mouth breathing is limited, restricted, or prevented.

[0190] 5.2 Treatment System

[0191] In one form, the technology includes a device or apparatus for treating respiratory disorders. The device or apparatus may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000.

[0192] 5.3 Patient Interface

[0193] refer to Figure 3 According to one aspect of the present technology, the non-invasive patient interface 3000 includes the following functional aspects: a sealing forming structure 3100, a pressurization chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, and a connection for connecting to an air circuit (e.g., air circuit 4170, such as...). Figure 1A-1C A connection port 3600 (as shown) is one form. In this example, the sealing formation 3100 and the pressurization chamber 3200 are provided by a cushion module 3150. The cushion module 3150 in this example is a support cushion module. In other examples, it could be a nasal pillow cushion assembly or other types of cushion assemblies.

[0194] 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.

[0195] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 6 cm H2O relative to the environment.

[0196] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 10 cm H2O relative to the environment.

[0197] According to one form of the present technology, a patient interface 3000 is constructed and arranged to supply air at a positive pressure of at least 20 cm H2O relative to the environment.

[0198] 5.3.1 Sealing Formation Structure

[0199] In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual sealing surface—can vary 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 structure, and the shape of the patient's face.

[0200] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0201] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material, such as silicone rubber.

[0202] The sealing structure 3100 according to this technology can be constructed from a soft, flexible and resilient material such as silicone.

[0203] In some forms of this technology, a system is provided comprising more than one sealing formation structure 3100, each sealing formation structure being configured to correspond to a different size and / or shape range. For example, the system may include one type of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0204] 5.3.1.1 Sealing Mechanism

[0205] In one embodiment, the sealing structure includes a pressure-activated auxiliary sealing flange utilizing a pressure-assisted sealing mechanism. In use, the pressure-assisted sealing flange readily responds to the system positive pressure acting on its bottom surface within the pressurization chamber 3200, thereby forming a tight seal with the face surface. This pressure-assisted mechanism can work in conjunction with the elastic tension in the positioning and stabilizing structure.

[0206] 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 pressure 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 pressure chamber 3200 and extends for at least a portion of the path around the circumference. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from bending during use.

[0207] 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 positioned in a compressed state, for example, as a result of elastic tension in the positioning and stabilizing structure.

[0208] 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.

[0209] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0210] 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.

[0211] In one form, the non-invasive patient interface 3000 includes a sealing structure that, during use, forms a seal in the bridge of the patient's nose or the nasal ridge region of the face and the upper lip region of the patient's face. In these forms, the sealing structure may be referred to as a nasal mask. This is, for example... Figure 1B The patient interface 3000 is shown. The sealing formation supplies air or breathable gas to both nostrils of the patient 1000 through a single orifice. This type of sealing formation can be referred to as a "nasal pad" or "nasal mask." In some examples of this technology, Figure 3 Alternatively, the positioning and stabilizing structure 3300 shown in Figure 4 can be used to hold the nose pad in a sealed position on the patient's face.

[0212] In one form, for example, Figure 3 As shown, the sealing forming structure 3100 is configured to form a seal around the nostrils with the underside of the nose during use, and optionally with the upper lip of the patient 1000. This type of sealing forming structure may be referred to as a "bracket pad" or "subnasal mask". The shape of the sealing forming structure can be configured to match or closely follow the underside of the patient's nose; that is, the contour and angle of the sealing forming structure can be substantially parallel to the patient's nasolabial angle. In one form of nasal support pad, the sealing forming structure includes a nasal portion defining two orifices, each orifice supplying air or breathable gas to a different one of the patient's nostrils during use. The nasal portion can be configured to contact or seal the patient's columella during use. In some forms of the technology, the sealing forming structure 3100 is configured to form a seal on the underside of the patient's nose without contacting the bridge region of the patient's nose. In some examples, the patient interface may include a seal-forming structure 3100 in the form of a stent liner as described in PCT application No. PCT / AU2018 / 050289 filed on March 29, 2018, the entire contents of which are incorporated herein by reference.

[0213] In one embodiment, the patient interface 3000 includes a sealing forming portion that, during use, forms a seal on the chin region, bridge of the nose region, and cheek region of the patient's face. This is, for example... Figure 1C The patient interface 3000 is shown. The sealing portion supplies air or breathable gas to the patient 1000's two nostrils and mouth through a single orifice. This sealing structure can be referred to as a "full-face mask." In some examples of this technology, Figure 3Alternatively, the positioning and stabilizing structure 3300 shown in diagram 4 can be used to hold the full-face pad in a sealed position on the patient's face. Alternatively, Figure 3 and 4 The positioning and stabilizing structure 3300 can be used with the patient interface 3000, which includes a nasal seal-forming structure in the form of a nasal pad or nasal support pad and an oral seal-forming structure, the oral seal-forming structure being configured to form a seal around the patient's mouth (which may be referred to as a "mouth pad" or "mask") during use. In such a mask, air or breathable gas is supplied to the patient's nostrils and mouth during use through orifices. This type of seal-forming structure 3100 may be referred to as a "naso-oral pad" where separate seals exist around the mouth and nose, or as an "ultra-compact full-face pad" where the nasal seal surrounds or is close to the patient's nostrils. In one form, the nasal seal-forming structure and the oral seal-forming structure are integrally formed as a single component. In some examples, the patient interface may include a seal-forming structure 3100 in the form of a support pad as described in U.S. Patent Application No. 62 / 649,376, the entire contents of which are incorporated herein by reference.

[0214] 5.3.2 Pressurization Chamber

[0215] In the area forming a seal during use, the pressurization chamber 3200 has a periphery shaped to complement the surface contours of a typical human face. During use, the boundary edges of the pressurization chamber 3200 are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 may extend along the entire periphery of the pressurization chamber 3200 during use. In some forms, both the pressurization chamber 3200 and the sealing structure 3200 are formed from a single sheet of homogeneous material.

[0216] In some forms of this technology, for example in Figure 3 In the patient interface 3000, the pressurization chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the pressurization chamber. This form tends to be less conspicuous and / or more comfortable for the wearer, which can improve treatment compliance.

[0217] In some forms of this technology, the pressurization 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 compliance. The use of a transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0218] In some forms of this technology, the pressure 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 compliance.

[0219] 5.3.3 Positioning and Stabilization Structure

[0220] The sealing structure 3100 of the patient interface 3000 of this technology can be kept in a sealed state during use by the positioning and stabilizing structure 3300. The positioning and stabilizing structure 3300 may be referred to as a "headband" because it engages with the patient's head to hold the patient interface 3000 in a sealed position.

[0221] 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 pressurization chamber 3200 to lift the face away.

[0222] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the gravitational effects on the patient interface 3000.

[0223] 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.

[0224] In one form of this technology, a positioning and stabilization structure 3300 is provided, constructed in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilization structure 3300 has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one example, the positioning and stabilization structure 3300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0225] 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 in a supine sleeping position, wherein the back area of ​​the patient's head is on a pillow.

[0226] 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 in a side-sleeping position, wherein the lateral area of ​​the patient's head is on the pillow.

[0227] 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 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 disrupting the seal.

[0228] In one form of this technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In another form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0229] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For example, the strap may be configured to be taut during use and to guide forces to bring the sealing structure into sealed contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0230] The frenulum will be understood as a structure designed to resist tension. In use, the frenulum can be part of the positioning and stabilizing structure 3300 under tension. As will be described, some frenulums will exert elasticity due to tension. The frenulum can be used to hold the sealing formation structure 3100 in a therapeutically effective position on the patient's head.

[0231] In one form of this technology, the positioning and stabilizing structure includes a first frenulum, which is constructed and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the supraacular base of the patient's head and covers a portion of the parietal bone but not the occipital bone. The first frenulum may be provided as, for example, part of a patient interface, including a support pad, nasal pillow, nasal pad, full-face pad, or oronasal pad. For example, Figure 3 The positioning and stabilizing structure 3300 includes a first tether in the form of a gas delivery tube 3350 located above the patient's head. The gas delivery tube 3350 may also be referred to as a headband tube 3350, as it provides the function of a headband.

[0232] In one form of this technology applicable to nasal masks only or to full-face masks, the positioning and stabilizing structure includes a second strap configured and arranged such that, in use, at least a portion of the upper edge of the second strap passes below the base of the lower ear on the patient's head and covers or is located below the occipital bone of the patient's head. The second strap may be provided as, for example, part of a patient interface, including a support pad, nasal pillow, full-face pad, nasal pad, or oronasal pad. For example, Figure 3 The positioning and stabilizing structure 3300 includes a second frenulum in the form of a strap 3310 resting against the posterior surface of the patient's head.

[0233] In one form of this technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap configured and arranged to interconnect the first and second straps to reduce the tendency for the first and second straps to separate from each other. Additionally, in some forms, the positioning and stabilizing structure includes a fourth strap configured and arranged to interconnect with the second and third straps to reduce the tendency for the second and third straps to move away from each other.

[0234] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is flexible and, for example, non-rigid. An advantage of this is that the strap makes it more comfortable for the patient to lie on it while sleeping. Figure 3 The positioning and stabilizing structure 3300 includes a flexible strap 3310. The strap 3310 can be considered a rear strap. The strap 3310 is flexible enough to wrap around the back of the patient's head and rest comfortably against the patient's head, even when it is under tension during use.

[0235] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0236] 5.3.3.1 Headband

[0237] In some forms of this technology, the positioning and stabilizing structure 3300 includes one or more tubes 3350 that deliver pressurized air received from a conduit forming part of an air circuit 4170 from the RPT device to the patient's airway, for example through a pressure chamber 3200 and a sealing structure 3100. Figure 3In the illustrated form of this technology, the positioning and stabilizing structure 3300 includes two separate gas delivery tubes 3350 that deliver air from the air circuit 4170 to the sealing-forming structure 3100. The tubes 3350 are integral parts of the positioning and stabilizing structure 3300 of the patient interface 3000 to position and stabilize the sealing-forming structure 3100 of the patient interface to an appropriate portion of the patient's face (e.g., nose and / or mouth). This allows the conduit of the air circuit 4170, which provides pressurized airflow, to connect to the connection port 3600 of the patient interface at a location other than in front of the patient's face, which may be unsightly for some individuals. While a pair of tubes 3350 has some advantages (described below), in some examples, the positioning and stabilizing structure 3300 includes only a single tube 3350 configured to cover one side of the patient's head. A strap or other stabilizing component may be positioned on the other side of the patient's head between the tip of the single tube 3350 and the sealing-forming structure 3100 to provide balancing forces on the sealing-forming structure 3100.

[0238] Because air can be included and passed through the headband tube 3350 to deliver pressurized air from the air circuit 4170 to the patient's airway, the positioning and stabilizing structure 3300 can be described as inflatable. It is understood that an inflatable positioning and stabilizing structure 3300 does not require all components of the positioning and stabilizing structure 3300 to be inflatable. For example, in Figure 3 In the example shown, the positioning and stabilizing structure 3300 includes an inflatable headband tube 3350 and a non-inflatable strap 3310.

[0239] In some forms of this technology, the patient interface 3000 may include a connection port 3600 located near the top, side, or rear of the patient's head. For example, in Figure 3 In the form of the present technology shown, the connection port 3600 is located at the top of the patient's head. In this example, the patient interface 3000 includes a bend 3610 to which the connection port 3600 is disposed. The bend 3610 is rotatable relative to the positioning and stabilizing structure 3300 to isolate the movement of the catheter connected to the connection port 3600 from the positioning and stabilizing structure 3300. Figure 4 As shown, the connection port can be configured as a fluid connection opening 3390 in the headband tube 3350, or as... Figure 3 The component connected to the headband tube 3350 is shown. Alternatively or alternatively, the conduit connected to the connection port 3600 can rotate relative to the bend 3610. In the example shown, the bend 3610 includes a rotating conduit connector, which includes the connection port 3600, to which the conduit of the air circuit 4170 can be connected, allowing the conduit to rotate about its longitudinal axis relative to the bend 3610. Figure 4In the example, air circuit 4170 can be connected to a fluid connection opening. Bend 3610 can be rotatably connected to the fluid connection opening or to a ring received in the fluid connection opening.

[0240] The connection port 3600 is not positioned in a way that would make the catheter connected to the patient interface 3000 in front of the face unsightly and / or protruding. For example, the catheter connected to the patient interface 3000 in front of the face may easily become tangled in bedding or sheets, especially if the catheter extends downward from the patient interface during use. The use of a patient interface with a connection port could make it easier or more comfortable for the patient to be in one or more of the following positions: lying on their side or supine; supine (i.e., lying on their back with their face up); and prone (i.e., lying face down). Furthermore, connecting the catheter to the front of the patient interface could exacerbate a problem known as tube drag, where the catheter may provide an undesirable dragging force on the patient interface, causing it to move away from the face.

[0241] exist Figure 3 and 4 In the form of the present technology shown, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 being positioned on a different side of the patient's head during use and extending across the corresponding cheek area, above the corresponding ear (above the supraaural base point of the patient's head, such as...). Figure 2C (As shown) a curved tube 3610 extending to the top of the patient's head. This form of technology can be advantageous because if the patient sleeps with their head turned to the side, and one tube is compressed to block or partially block the flow of gas along that tube, the other tube remains open to supply pressurized gas to the patient. In other examples of the technology, the patient interface 3000 may include a different number of tubes, such as one tube, or three or more tubes. In one example, the patient interface has a tube 3350, which is positioned on one side of the patient's head during use (e.g., across a cheek area), and a strap forms part of the positioning and stabilization structure 3300 and is positioned on the other side of the patient's head during use (e.g., across another area) to help secure the patient interface 3000 to the patient's head.

[0242] like Figure 4 As shown, the positioning and stabilizing structure can alternatively be configured as a single gas delivery tube with a left arm and a right arm. In the example shown, the connection port 3600 is located on the upper side of the positioning and stabilizing structure, instead of as... Figure 3 The example shows a separate connection module.

[0243] In one form of this technology, the patient interface 3000 is configured such that the connection port 3600 is positioned approximately at the top of the patient's head. The connection port 3600 can be positioned in the sagittal plane and aligned with a supraacus base point in a plane parallel to the coronal plane. Figure 2C The base point on the ear is marked in the middle. In some forms of the technology, the positioning and stabilizing structure 3300 is configured to be worn in different positions, the effect of which is that the connection port 3600 can be positioned near the top of the patient's head in the sagittal plane, up to about 20 mm in front of or about 20 mm behind the base point on the ear.

[0244] As described above, in some examples of this technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a support pad, which is typically located below the nose and seals to the lower periphery of the nose. A positioning and stabilizing structure 3300 can be configured and arranged to pull the seal-forming structure 3100 into the patient's face below the nose using a sealing force vector having a posterior and superior direction (e.g., posterosuperior direction). A sealing force vector having a posterosuperior direction can help the seal-forming structure 3100 form a good seal against the lower periphery of the patient's nose and the forward-facing surfaces of the patient's face on either side of the nose or upper lip.

[0245] In some examples, the positioning and stabilizing structure 3300 can apply a sealing force vector during use, the sealing force vector having a posterosuperior direction at approximately 35° relative to the patient's Frankfurt horizontal plane (in Figure 2D (Identified in the middle). The upper portion of tube 3350 (e.g., the portion of tube 3350 above strap 3310) may be vertically oriented, and the posterior headband strap 3310 may extend from tube 3350 in a rearward direction at an angle of approximately 35° relative to the patient's Frankfurt plane. In this particular configuration, an angle θ of approximately 125° is formed between strap 3310 and the upper portion of tube 3350, wherein strap 3310 is connected to tube 3350. In other examples, θ may be greater than or less than 125°.

[0246] exist Figure 3 and 4 In the form of the technology shown, two tubes 3350 are fluidly connected to each other at their upper ends and fluidly connected to a connection port 3600. Figure 3 In this configuration, tube 3350 is a separate tube connected to crown connector 3360. Tubes 3350 are indirectly connected to each other via crown connector 3360 and can be disconnected, for example, for cleaning, storage, or replacement. Figure 4In this configuration, two tubes are integrally formed and a connection port 3600 is included as a fluid connection opening 3390, to which a swivel elbow is connected. In other examples using separate tubes, they may be indirectly connected together, for example, each may be connected to a T-shaped catheter with two catheter arms, each catheter arm being fluidly connected to tube 3350. The coronal connector 3360 may include a third catheter arm. The connection port 3600 may include a bend 3610 received in the fluid connection opening 3390 at the center of the coronal connector 3360. The bend 3610 may be received in a ring within the fluid connection opening 3390 and may be configured to rotate within the ring. The fluid connection opening 3390 itself may also be considered as the connection port 3600.

[0247] Figure 3 and 4 The tube 3350 in the illustrated technical form has a length between 15 and 30 cm, for example, between 20 and 27 cm. The tube length is chosen to suit the size of a typical patient's head, for example, the area near the top of the head where the upper end of the tube 3350 is located, and when it descends along a roughly arc-shaped path along both sides of the head and passes through the patient's cheek area (such as...). Figure 3 and 4 The distance between the area near the patient's airway opening (the arcuate path taken by the tube 3350 shown), where the lower end of the tube 3350 connects to the pressurization chamber 3200 at that opening. In some examples, the patient interface 3000 may be configured such that the length of the tube 3350 can be varied. It should be understood that the length of the tube 3350 will depend on the length of other components in the patient interface 3000, such as the length of the coronal connector 3360 to which the upper end of the tube 3350 is connected and / or the size of the pressurization chamber 3200.

[0248] The gas delivery tube 3350 may have a circular, elliptical, oval, D-shaped, trapezoidal, or rounded rectangular cross-sectional shape, such as that described in U.S. Patent No. 6,044,844, the contents of which are incorporated herein by reference. A cross-sectional shape that presents a flat surface of the tube on the side facing and in contact with other parts of the patient's face or head may be more comfortable to wear than, for example, a tube with a circular cross-section.

[0249] The cross-sectional width and / or height of tube 3350 can be in the range of 8-35 mm. In some forms where the tube has a generally D-shaped cross-section, the tube can have a width in the range of 15-25 mm and a height in the range of 6-15 mm. The height can be considered as the dimension of the tube extending away from the patient's face during use, i.e., the distance between the outermost portions of the patient contact portion 3348 and the non-patient contact portion 3349, while the width can be considered as the dimension spanning the surface of the patient's head. The cross-sectional thickness of the material forming tube 3350 can be in the range of 0.8-1.6 mm, for example, 1.0-1.5 mm.

[0250] 5.3.3.1.1 Gas delivery pipe structure

[0251] In the example of this technology, Figure 5 A cross-section of a gas delivery tube 3350 with a generally D-shaped profile is shown. In use, the flat side of the profile contacts the patient's face and head and should be understood as the patient contact portion of the gas delivery tube. The convex or arcuate side of the profile should be understood as the non-patient contact portion of the gas delivery tube. In some examples, the gas delivery tube may have a more square or rectangular profile, configured with slightly rounded corners for patient comfort.

[0252] The gas delivery tube 3350 is constructed of at least substantially a fabric material and / or a foam material, and at least substantially a transparent material of elasticity. The transparency of the elastic material, i.e., its light transmittance, is such that it is translucent. In some examples, the transparency may be high, with minimal or no deflection of transmitted light, making the transparency of the elastomeric material similar to that of glass or a film. In other examples, the transparent material may have some limited deflection of transmitted light, making the transparent elastomeric material somewhat blurred but sufficient for the patient to detect noticeable dirt and mold.

[0253] In use, the gas delivery tube is configured such that the patient contact portion of the gas delivery tube, i.e., the part that contacts the patient's face and head, is primarily made of fabric material. A transparent material is included in at least a portion of the non-patient contact side of the gas delivery tube.

[0254] This design provides a gas delivery tube that serves as part of a positioning and stabilizing structure for patient comfort while also allowing for inspection of the tube's interior. This likely means that build-up of dirt or mold inside the gas delivery tube can be visually detected. The patient can disconnect the gas delivery tube 3350 from the pressurization chamber 3200 to remove any debris detected inside. When the gas delivery tube is cleaned, the transparent material allows the patient to confirm that any dirt and mold have been removed.

[0255] In some forms of this technology, the gas delivery pipe 3350 is made of a translucent material. The use of a translucent material can function in substantially the same way as a transparent material, and can be used in any embodiment in addition to or in place of a transparent material.

[0256] Another advantage of this construction is that the fabric and elastic materials can be combined to achieve an overall look and feel, providing a potentially higher quality feel compared to traditional gas delivery tubes made entirely of fabric or elastic materials. Furthermore, the integrated construction allows for lower cost and lighter weight compared to traditional gas delivery tubes.

[0257] 5.3.3.1.2 Fabrics / Foam Materials

[0258] The flat side 3351 of the gas delivery tube 3350 forms the patient contact side of the gas delivery tube. It is composed of a fabric material. In this example, the fabric material may have at least two layers: an inner layer 3352 consisting of an impermeable layer, such as a film or laminate of silicone or another elastomeric plastic material (e.g., TPE); and an outer fabric layer 3353 forming the exterior of the gas delivery tube 3350. The inner layer 3352 is bonded to the outer fabric layer 3353. In some other examples, an additional layer may be provided between the impermeable layer and the outer fabric layer, such as an intermediate adhesive layer bonding the impermeable layer to the outer fabric layer 3353. In yet another example, the fabric material may comprise a single layer. In these examples, the fabric material may be inherently impermeable, such that no additional film or laminate is required.

[0259] In some examples of this technology, such as Figure 3 and 4 In the example shown, the headband tube 3350 includes a patient contact side formed at least partially of the fabric material as described above. Additionally or alternatively, the patient contact side of the gas delivery tube 3350 may be formed of a foam material. In some examples, the tube 3350 includes a combination of fabric and foam materials. The fabric and / or foam material comprising the patient contact side of the gas delivery tube may: retain air under pressure, be biocompatible and suitable / approved for forming a medical air path, be lighter than silicone tubing, be soft and flexible, generally maintain a predetermined shape, be cleanable, and be durable for a predetermined lifespan, such as one month, three months, six months, one year, or longer.

[0260] As previously described, the arched side 3354 of the D-shaped profile forms the non-patient contact portion of the gas delivery tube. In one example, at least a section of the non-patient contact portion comprises, in the same manner as the patient contact side, at least two layers of fabric material; an inner layer comprising an airtight layer formed of an elastomeric plastic material bonded to the outer fabric layer. However, in other examples, the fabric material that may include a portion of the non-patient contact portion may be sufficiently airtight, eliminating the need for an inner layer, and the non-patient contact portion may comprise a single layer of fabric material and a transparent material. The fabric material of the non-patient contact side 3354 may be reinforced (e.g., by the airtight layer, by additional reinforcements, etc.) to help maintain the sharp shape. Alternatively, reinforcements may be omitted, and the arched D-shape may be formed only when pressurized air flows through the gas delivery tube 3350.

[0261] In one example, the fabric material constituting the gas delivery pipe can be a mixture of polyamides, such as nylon, polyester, and / or spandex, with a weight of 50 g / m². 2 Up to 250g / m 2 Between. In another example, the fabric material could weigh up to 120g / m². 2 The material. In some examples, the inner layer of the fabric material may include two or more silicone laminates. In one example, each silicone laminate may be 5 to 75 micrometers thick. In another example, each silicone laminate may be 20 to 30 micrometers thick, preferably 25 micrometers thick.

[0262] Having fabric on the outside of the gas delivery tube on both the patient contact side and the non-patient contact side is advantageous. On the patient contact side, it is more comfortable when in contact with the face, while on the non-patient contact side, when the patient interface is worn in bed, there is less friction when the gas delivery tube comes into contact with other fabrics, such as pillows or sheets. It also feels more aesthetically pleasing.

[0263] 5.3.3.1.3 Transparent Material – Window Section

[0264] exist Figure 5 and 6 In the example, the front and rear sides 3355, 3356 of the D-shaped profile where the patient contact side and the non-patient contact side of the gas delivery tube 3350 meet are formed of a transparent material. This transparent material forms window segments in the profile of the gas delivery tube 3350, allowing the user to visually inspect its interior. This allows for easier detection of mold and / or dirt buildup and facilitates better cleaning of the interior while still maintaining the comfort of the essentially fabric exterior.

[0265] exist Figure 5 and 6In the example, the patient contact side 3351 and the non-patient contact side 3354 of the gas delivery tube 3350 are both formed from a single strip of fabric material. Furthermore, Figure 5 and 6 The gas delivery tube is configured with two window sections, one along each of the front side 3355 and the rear side 3356 of the gas delivery tube. In the example shown, a transverse axis TA may extend through both the front side 3355 and the rear side 3356 in a direction transverse to the longitudinal axis LA, which generally extends along at least a portion of the gas delivery tube 3350 in the direction of pressurized airflow (e.g., along the interface between the pressurization chamber 3200 and the positioning and stabilization structure 3300). The transverse axis may not intersect either fabric strip. For example, the transverse axis may extend along the fabric strip forming the patient contact side 3351 in the front / back direction, but does not intersect the fabric strip forming the non-patient contact side 3354. A patient observing along the transverse axis TA can see completely through the gas delivery tube 3350. In other words, when viewed along the transverse axis TA, the gas delivery tube 3350 does not include opaque material. The patient can more clearly identify debris within the gas delivery tube 3350 because such debris may obstruct a clear view along the transverse axis TA. However, the periphery of the gas delivery pipe 3350 includes both fabric and transparent material, such that the transverse plane relative to the longitudinal axis LA (i.e., the plane including the transverse axis TA) (i.e., in) Figure 5 The cross-section observed includes both transparent and fabric materials in the direction exposed to the patient (e.g., for visual examination).

[0266] Each strip of fabric material has opposing edges along its elongated dimension; the transparent material of the window segment is bonded to the corresponding edges of the patient contact side 3351 and the non-patient contact side 3354 using adhesive or thermal welding techniques. In other examples, the window segment may be overlaid onto the edges of the fabric material molded to the patient contact side 3351 and the non-patient contact side 3354.

[0267] In other examples, the non-patient contact side 3354 may be formed by two or more strips of fabric material dispersed with a transparent material. For example, the non-patient contact side 3354 may be formed by two strips of fabric material separated by a single transparent material strip, joined or overmolded to the respective edges of the fabric material. This places the window segments at the center of the arcuate side of the D-shaped profile, except for window segments 3355, 3356 on either side of the D-shaped profile. In yet another example, the patient contact side and non-patient contact side of the gas delivery tube are formed by a single strip of fabric material, with the edges of the fabric material positioned substantially centrally on the non-patient contact side 3354 of the D-shaped profile or alternatively on one side. The window segments in this example are located between the elongated edges of the fabric material. In other words, the transparent material is positioned (e.g., overmolded) between the elongated edges of the fabric material such that the edges are not fully joined. In this example, the patient will have only a single viewing window and will not be able to see completely through the gas delivery tube 3350.

[0268] In these examples, the transparent material forming window segments 3355 and 3356 is an elastomeric material. In one such example, the transparent material is medical-grade silicone. In some examples, the silicone may be selected from silicones having Shore A hardness tester measurements in the range of 35 to 45; that is, from soft to medium soft. In other examples, the silicone has a Shore A hardness tester measurement between 38 and 42. In one such example, the silicone has a Shore A hardness tester measurement of 40.

[0269] In some cases, a harder hardness tester can be used to measure greater structural integrity for the gas delivery tubing. However, this could also mean a greater likelihood of increased pressure if the non-patient contact side unintentionally comes into contact with the patient's face when the positioning and stabilizing structure is worn. This could potentially cause patient discomfort.

[0270] In other examples, the transparent material can be a TPE or TPU with appropriate flexibility. The advantages of TPE are its relatively low cost and the lower operating temperature. For example, TPE can be molded at temperatures below 50°C with a shorter cycle time than elastomer materials such as silicone.

[0271] In one example, window segments 3355 and 3356 are formed by overmolding silicone onto strips of fabric material, forming the patient contact side 3351 and the non-patient contact side 3354, respectively. In some examples, the fabric material may be laminated or coated to form an impermeable layer before being cut into strips, but in other examples, the strips may be laminated after manufacturing, for example, by plain knitting.

[0272] In one manufacturing example, a strip of fabric material is inserted into a mold, and window segments 3355 and 3356 are molded onto the fabric material. This allows for the formation of an integral structure between the fabric material and the transparent material. Figure 5 and 6 In this design, window sections 3355 and 3356 include a semi-circular profile 3357 within the hollow interior of the gas delivery tube, which may have a shape complementary to profile 3357. These facilitate the flow of silicone during molding, thereby promoting adhesion to the fabric tape before the portion forming the window section is filled. This causes the fabric tape on either side of the window section to face each other for a more secure bond. Conversely, forming the window section first would cause the fabric tape to shift, thus affecting the quality and appearance of the gas delivery tube.

[0273] In some examples, a portion of the gas delivery pipe may be configured with one or more window segments, while in other examples, the entire length of the gas delivery pipe 3350 may be configured with one or more window segments 3355, 3356. In still other examples, the length of the gas delivery pipe may be configured to have a series of window segments arranged at intervals and / or at key locations. For example, in some forms, the lower portion of the gas delivery pipe 3350 near the pressurization chamber 3200 has one or more window segments, while the upper portion of the gas delivery pipe near the connection port of the air supply does not. In some of these examples, at least some individual window segments may be separated from adjacent window segments by segments of fabric or foam material.

[0274] 5.3.3.1.4 Transparent material – non-patient contact side

[0275] In another example, Figure 7 A gas delivery tube 3350 with a generally D-shaped profile is shown. The curved portion of the profile is the non-patient contact side 3354 of the gas delivery tube 3350 and may be entirely formed of a transparent material, while the flat portion of the profile is the patient contact side 3351 of the gas delivery tube and is entirely made of fabric or foam material. The patient contact 3351 and the non-patient contact 3354 are joined at their respective flanges, which, in use, form the front and rear sides of the gas delivery tube 3350, respectively.

[0276] In other examples, the gas delivery pipe may have a substantially square or rectangular outline, rather than... Figure 7 The D-shaped profile may include rounded corners for patient comfort. In contrast to sharp corners, rounded corners help reduce potential failure locations (e.g., locations where the gas delivery tube 3350 may fail due to repeated pressurization and depressurization).

[0277] Figure 7The arrangement described in the example may be advantageous because it will provide a comfortable catheter headband, but will also allow at least a portion of the interior of the gas delivery tube (if not its entire length) to be visible to the patient. Inspection and cleaning of the gas delivery tube can be performed more easily. In other examples, only a portion of the length of the non-patient contact side may be made of a transparent material. For example, only the non-patient contact side of the lower end of the gas delivery tube may be made of a transparent material. In another example, the non-patient contact side of the upper end of the gas delivery tube may be made of a transparent material.

[0278] In these examples, the transparent material forming the non-patient contact side 3354 is an elastomeric material. In one such example, the transparent material is medical-grade silicone. In some examples, the silicone may be selected from silicones having a Shore A hardness tester measurement value in the range of 35 to 45; that is, from soft to medium soft. In other examples, the silicone has a Shore A hardness tester measurement value in the range of 38 to 42. In one such example, the silicone has a Shore A hardness tester measurement value of 40.

[0279] In other examples, the transparent material can be TPE or TPU with appropriate softness. The harder the hardness measured by the hardness tester, the greater the likelihood of increased pressure if the non-patient contact side 3354 unintentionally comes into contact with the patient's face when the positioning and stabilization structure of the patient interface is worn. This could lead to patient discomfort.

[0280] In this example, for patient comfort, the patient contact side 3351 of the gas delivery tube 3350 is made of an opaque fabric material as described above. Figure 7 In this embodiment, the fabric layer comprises an inner layer in the form of an impermeable layer 3352 of silicone or similar laminated material. In some examples, an additional adhesive layer or additional laminated layer may be provided. As described for this example, a flow path is formed between the internal gas-impermeable layer 3352 and the non-patient contact side 3354, which is entirely composed of an elastomeric material and is therefore medically compatible with clean gas flow.

[0281] Alternatively or alternatively, the patient contact side 3351 may be formed of or may include a foam material. In some examples, the tube 3350 may include a combination of fabric and foam material. The fabric and / or foam material of the patient contact side 3351, which includes the gas delivery tube, may: retain air under pressure, be biocompatible and suitable / approved for forming a medical air path, be lighter than silicone tubing, be soft and flexible, generally maintain a predetermined shape, be cleanable, and be durable for a predetermined lifespan, such as one month, three months, six months, one year, or longer.

[0282] In some examples, the non-patient contact side 3354 of the gas delivery tube 3350 may at least partially include one or more accordion-style sections 3358, such as... Figure 8 As shown. Each accordion-shaped section 3358 may include a portion of a gas delivery tube 3350 having one or more folds, pleats, corrugations, or bends as described in PCT application No. PCT / AU2019 / 050874, the contents of which are incorporated herein by reference.

[0283] In some examples, the accordion-style section can extend a portion of the length of the gas delivery tube beyond the patient contact side, such as... Figure 8 As shown, however, in other examples, the accordion-shaped segment may extend the entire length of the gas delivery tube on the non-patient contact side. In another example, the accordion-shaped segment 3358 may be located at key points along the length of the gas delivery tube. For example, the accordion-shaped segment may be located at points corresponding to the curves of the patient's head (such as the top of the head and around the jaw, below the line of the mouth), but not on the generally flat parts of the head (such as the sides of the head, between the supraauricular and subauricular base points), to help locate and stabilize structures conforming to the shape of the patient's head.

[0284] In other examples, the accordion-shaped section may extend partially around the circumference of the non-patient contact side of the gas delivery tube. In one example, the accordion-shaped section may extend to include both the rear and front sides of the gas delivery tube. In yet another example, the accordion-shaped section may extend completely around the circumference of the gas delivery tube. In this example, the accordion-shaped section may surround both the patient contact side and the non-patient contact side of the gas delivery tube. Compared to other examples where the accordion-shaped section extends only around the circumference or a portion of the circumference of the non-patient contact side, this example can have a greater extension capability to increase the length of the gas delivery tube.

[0285] exist Figure 11 and 12 In the examples, the accordion-style section 3358 of the gas delivery tube 3350 is at least partially constructed of a fabric or foam material, and at least partially of a transparent material, such as silicone, TPE, or TPU as previously described in the previous examples. In some examples, the fabric or foam material may be provided only on the patient contact side of the gas delivery tube, while the non-patient contact side is partially or entirely constructed of a transparent material. The fabric and transparent materials may have similar tensile properties, allowing the patient and non-patient sides to stretch together (e.g., the accordion shape does not bend when stretched). However, in Figure 11 and 12In this example, the non-patient contact side comprises an elongated strip of fabric material in the form of a fabric pad 3308 extending along the length of the gas delivery tube. In this example, the gas delivery tube 3350 is entirely made of a transparent material, and the fabric pad 3308 has been bonded (e.g., by overmolding, adhesive, etc.) to the non-patient contact side of the gas delivery tube 3350. In other words, the fabric material in this example does not come into contact with the compressed air as it flows through the gas delivery tube 3350.

[0286] In some further examples, an accordion-style section is provided on both the non-patient contact side and the patient contact side. In this example, the accordion-style section on the patient contact side may also be made of fabric or foam material for patient comfort.

[0287] The use of a gas delivery tube 3350 with one or more accordion-style sections gives the gas delivery tube 3350 some elongation and bending capabilities, which is advantageous in providing a catheter headband that can better conform to the shape of the patient's head. For example, in Figure 10 In the positioning and stabilizing structure 3300, the upper part of the gas delivery tube 3350 is provided with an accordion-style section 3358. This is advantageous because it allows the gas delivery tube to have a certain degree of extension and / or flexibility to conform to the upper part of the patient's head.

[0288] like Figure 8 As shown, the accordion-style section 3358 may include a series of alternating external ridges 3359A and grooves 3359B formed along at least a portion of the non-patient contact side 3351 of the gas delivery tube 3350. In some examples, the corresponding ridges and grooves may be provided inside the gas delivery tube, but this would compromise the cost efficiency of manufacturing.

[0289] In some examples, the alternating ridges 3359A and grooves 3359B can act like pleats or bellows that can be folded and unfolded independently or uniformly to shorten or lengthen the accordion-like segment 3358 and thus the corresponding gas delivery tube 3350. A greater groove depth (or ridge height) can provide a more extendable or more flexible tube 3350. When tension is applied to the tube 3350, the ridges 3359A and grooves 3359B of the extendable accordion-like segment 3358 can pull away from each other, straightening the tube walls and thus lengthening the tube 3350. In this example, the accordion-like segment 3358 is biased to its original (e.g., unextended) length. When the headband tension is released, the ridges 3359A and grooves 3359B are biased back to their initial structure, where the accordion-like segment 3358 and the tube 3350 have their initial length. This can help the gas delivery tube conform to the shape of the patient's head. The stretching or extension of the accordion-shaped section on the gas delivery pipe 3350 can be substantially elastic, so that it provides a similar force to the pressurization chamber 3200 each time the pressurization chamber is used continuously.

[0290] In other examples, the alternating ridges 3359A and grooves 3359B of the accordion-like segment can be formed as corrugations, allowing the gas delivery tube to deform and bend. In this example, the accordion-like segment may have only limited or no function to shorten or lengthen. The ridges 3359A and grooves 3359B can help change the shape of the accordion-like segment 3358 of the gas delivery tube 3350, which helps to align the gas delivery tube with the patient's head.

[0291] 5.3.3.1.5 Rigidity

[0292] In some examples of this technology, the gas delivery pipe 3350 or a portion of the gas delivery pipe of the positioning and stabilizing structure 3300 can be configured to resist bending more strongly than in other directions or along axes or around some directions or axes. A pipe 3350 including relatively rigid portions on both the front and rear sides can advantageously have a higher resistance to bending towards the front and rear sides of the pipe 3350 during use. However, in some examples, a rigid portion is provided only on one of the front or rear sides of the pipe 3350, because, depending on the rigidity, a rigid portion on only one side can provide sufficient resistance to bending in both directions. In other examples, the rigid portion can be provided along the entire length of the gas delivery pipe 3350, while in other examples, the rigid portion is provided only to a portion of the length of the gas delivery pipe 3350. For example, the rigid portion can be provided on one of the lower or upper parts of the pipe. For example, compared to the orthogonal direction, Figure 3 and 4The upper portion of each tube 3350 of the positioning and stabilizing structure 3300 shown can be more flexible in a particular direction. For example, making the upper portion of the gas delivery tube more flexible can help position and stabilize structures that conform to the shape of the patient's skull, particularly the curvature around the top of the head.

[0293] Each gas delivery tube 3350 of the positioning and stabilizing structure 3300 may include an upper tube portion 3304 in use, which extends, for example, from the top of the patient's head backwards around a base point above the ear and is configured to cover the upper region of the patient's head in use. Conversely, Figure 3 and 4 The lower portion 3306 of each tube 3350 of the positioning and stabilizing structure 3300 shown, which extends backward from the base point above the ear on the patient's head during use, can be more flexible in a particular direction compared to the orthogonal direction.

[0294] In some examples of this technology, the upper tube portion 3304 may also include one or more reinforcements relative to the lower tube portion 3306. The reinforcements may be configured to provide higher resistance in the forward and / or rearward directions than in the upward and / or downward directions. This may be advantageous when dealing with any resistance, such as that caused by the air circuit. In some examples, the reinforcement may be provided along the entire length of the tube 3350, and in some examples, different stiffness may be provided along the length of the tube 3350.

[0295] In the example, the reinforcement of the gas delivery pipe can be provided by a window section. Because the window section is formed of an elastic material, it inherently has greater rigidity than at least most of the fabric or foam material forming the rest of the gas delivery pipe.

[0296] In some examples, the relative stiffness of the gas delivery pipe can be determined by the construction of the window section. For example, in Figure 5 In one implementation, the stiffness of the gas delivery pipe 3350 can be increased by increasing the thickness of one or both of the window segments 3355 and 3356. In another example, the stiffness of the gas delivery pipe can be increased by decreasing the thickness of one of the window segments 3355 relative to the other window segment 3356. Depending on the desired stiffness, the thickness of the window segments can be increased or decreased along the length of the gas delivery pipe 3350. This can give different stiffness to the lower portion 3306 and the upper portion 3304 of the gas delivery pipe.

[0297] A similar increase in the stiffness of the gas delivery tube can be achieved by increasing the relative width of one or both of the window segments 3355 and 3356, i.e., reducing the amount of fabric material present and increasing the amount of silicone present in the window segments, i.e., increasing the ratio of the surface area of ​​the window segments to the fabric material on the non-patient contact side of the gas delivery tube. The ratio of the window segments to the fabric material can be from 1:10 to 1:1. For example, in Figure 5 In this configuration, window sections 3355 and 3356 are approximately one-eighth the width of the fabric strip forming the non-patient contact side 3354, a ratio of 1:8. Doubling the width of window sections 3355 and 3356 while correspondingly reducing the width of the fabric material forming the non-patient contact side 3354 increases the stiffness of the gas delivery tube. The width of the window sections can be increased or decreased along the length of the gas delivery tube 3350, thereby providing different stiffnesses for the lower part 3306 and the upper part 3304 of the gas delivery tube.

[0298] Rigidity can also be increased in the gas delivery tube 3350 by adding (e.g., stitching) stiffening threads to the fabric material. Stiffening threads can provide stiffness to the fabric material without substantially increasing its weight. Stiffening threads can be used to replace window segments with increased width to reduce weight and improve patient compliance.

[0299] In embodiments where window sections 3355 and 3356 are positioned along the rear and front sides of the gas delivery pipe (e.g., in...), Figure 5 and 6 In the middle section, one or more of the window segments can be configured to have greater stiffness than the other. For example, the window segment on the front side of the gas delivery tube can be configured to have greater stiffness than the window segment on the rear side of the gas delivery tube. This may mean that the gas delivery tube 3350 is more resistant to forces applied from the rear (such as that that may occur when the gas circuit is dragged or gripped on bedding or the like). In another example, the window segment on the rear side of the gas delivery tube can be configured to have greater stiffness than the window segment on the front side of the gas delivery tube. This may mean that the gas delivery tube 3350 is more resistant to forces applied from the front.

[0300] 5.3.3.1.6 Replaceable gas delivery pipe construction

[0301] In another example of this technique, Figure 9The lower portion 3306 of the gas delivery tube 3350 is shown when the gas delivery tube has been separated from the pressurization chamber 3200. In contrast to the previous embodiment, the patient contact side 3351 and the non-patient contact side 3354 of the gas delivery tube 3360 are primarily constructed of a transparent material in the form of an elastomer. This means that the flow path within the gas delivery tube 3350 (or its main portion) is entirely defined by the elastomer. In this example, the elastomer is silicone, which is impermeable and medically suitable for defining a hygienic flow path. Other examples of elastomers could be TPE or TPU.

[0302] The patient contact side 3351 is configured to permanently or temporarily receive a fabric pad 3308, which provides a comfortable, soft surface for contact with the patient's face during use. In other words, the fabric pad 3308 does not form part of a channel through which pressurized air flows. In this example, the fabric pad 3308 may be added during manufacturing or alternatively provided separately to the gas delivery tube for the patient to attach to when needed. This could allow for the provision of non-woven catheter headbands, allowing the patient to place the fabric pad on certain areas of the patient contact side of the gas delivery tube according to their preference. For example, the fabric pad could be applied to the upper part of the gas delivery tube 3350, which contacts the top of the patient's head.

[0303] Since the fabric pad 3308 does not need to be configured as a surface forming part of the flow path of the gas delivery tube 3350, this function is achieved entirely by a transparent material forming at least the main portion of the flow path within the gas delivery tube, thus eliminating the need for a fabric with a gas-impermeable layer. The fabric pad 3308 can be made of one or more fabrics, such as nylon, polyester, or elastic fibers, or mixtures thereof. In some examples, the fabric pad 3308 can be made of a sufficiently stretchable and elastic material such that it does not restrict the flexibility of the catheter headband 3300, for example, to allow… Figures 10 to 12 The accordion-style section 3358 of the catheter headband is ready for movement.

[0304] In these examples, the fabric pad 3308 is bonded to the transparent material using an adhesive or similar bonding agent. In other examples, the fabric pad 3308 can be secured to the transparent material, for example, using a hook-and-loop material such as VELCRO™. In still other examples, the transparent material can be overmolded onto the fabric pad 3308.

[0305] In some examples, to aid in positioning the fabric pad 3308, the patient contact side 3351 of the gas delivery tube 3350 may be molded or otherwise formed to include partial recesses or depressions. This is advantageous in providing a highly integrated appearance and feel for the gas delivery tube 3350, which can make it more appealing to consumers. In some examples, the recesses may be provided with one type of hook-and-loop material, and the reverse side of the fabric pad 3308 may be provided with another type of hook-and-loop material. This allows the fabric pad to be removed for cleaning to remove skin oils and dirt accumulated from contact with the patient's face.

[0306] exist Figure 9 In this configuration, the fabric pad 3308 extends upward from the lower end of the gas delivery tube 3350 as far as the tab 3312 extending rearward from the gas delivery tube. In some examples, the fabric pad 3308 may be configured to have a corresponding tab such that the tab covers the tab 3312 of the gas delivery tube 3350. This can improve comfort when the protrusion 3312 of the gas delivery tube comes into contact with the patient's face and / or hair during the wearing positioning and stabilization structure.

[0307] Figure 9 Only the lower portion 3306 of the gas delivery pipe is shown with a fabric pad 3308, but in other examples, the upper portion 3304 of the gas delivery pipe 3350 may also be configured with a fabric pad 3308. This can be a fabric pad separate from the lower portion 3306 of the gas delivery pipe, or as... Figure 10 As shown, a single fabric pad can cover the upper portion 3304 and the lower portion 3306 of the gas delivery tube 3350. The fabric material covering the upper portion 3304 and the lower portion 3306 may be particularly beneficial for patients with little or no hair on their scalp or sides of the head and who dislike contact between the elastomeric material and their skin. The risk of the elastomeric material clamping and pulling on the patient's hair is also minimal should the positioning and stabilizing structure move unintentionally over the patient's head.

[0308] In some examples, for example Figure 11 and 12 In one example, the patient contact side of the gas delivery tube 3350 includes a fabric pad 3308. This fabric pad can also be applied to the non-patient contact side of the gas delivery tube 3350 without covering the window sections 3355 and 3356. In this example, a transparent material forms at least a majority of the flow path within the gas delivery tube. The use of the fabric pad 3350, bonded using adhesives, molding techniques, or hook-and-loop materials such as VELCRO™, can provide a smooth finish to the non-patient contact side of the gas delivery tube, which is aesthetically pleasing and comfortable to the touch if the patient requires it (e.g., when putting on and taking off positioning and stabilizing structures).

[0309] 5.3.4 Vent

[0310] In one form, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0311] In some configurations, the vent 3400 is configured to allow continuous ventilation flow from the interior of the pressurization chamber 3200 to the surrounding environment, while the pressure within the pressurization chamber is positive relative to the surrounding environment. The vent 3400 is configured such that the vent flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the treatment pressure within the pressurization chamber during use.

[0312] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0313] Vent 3400 may be located in pressurization chamber 3200. Alternatively, vent 3400 may be located in decoupling structure (e.g., bend rotator).

[0314] 5.3.5 Decoupling Structure

[0315] In one form, the patient interface 3000 includes at least one decoupling structure, such as a spindle or ball head and ball socket.

[0316] 5.3.6 Connection Port

[0317] Connection port 3600 allows connection to air circuit 4170.

[0318] 5.3.7 Anti-asphyxiation valve

[0319] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0320] Port 5.3.8

[0321] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the pressurization chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the properties of the gas within the pressurization chamber 3200, such as pressure.

[0322] 5.4RPT equipment

[0323] According to one aspect of the present invention, an RPT device 4000 includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300. The RPT device 4000 can be configured to generate an airflow for delivery to a patient's airway, for example, for treating one or more respiratory conditions described elsewhere in this document.

[0324] In one configuration, the RPT device 4000 is constructed and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0325] 5. Glossary

[0326] 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. 5

[0328] 5.1 General Rules

[0329] 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.

[0330] 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.

[0331] For example, the environment relative to a humidifier humidity This could be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's bedroom. This ambient humidity can differ from the humidity outside the patient's bedroom.

[0332] In another example, environmental stress can be stress that is directly around the body or outside the body.

[0333] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room, excluding noise generated by, for example, RPT devices or from masks or patient interfaces. Ambient noise can be generated by sound sources outside the room.

[0334] 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.

[0335] Continuous positive airway pressure (CPAP) therapy: In this therapy, the treatment pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in response to the absence of such an indication.

[0336] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be a scalar quantity, that is, a quantity that only has a magnitude. In other cases, the reference to flow rate will be a vector quantity, that is, a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated as 'flow' or 'airflow'.

[0337] In the example of patient breathing, the flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Total flow rate Qt is the flow rate of air leaving the RPT device. Tidal flow rate Qv is the flow rate of air leaving the exhaust port to allow flushing of exhaled gas. Leakage flow rate Ql is the leakage flow rate from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0338] Humidifier: The term humidifier will be considered to refer to a humidifying device that is constructed and arranged or configured with a physical structure that provides a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve the patient’s medical respiratory condition.

[0339] Leakage: The word leakage is considered to be undesirable airflow. In one example, leakage could occur due to an incomplete seal between the mask and the patient's face. In another example, leakage could occur in a swivel bend leading to the surrounding environment.

[0340] Patient: A person, regardless of whether they have a respiratory illness.

[0341] 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 It is approximately 0.98 hectopascals. In this specification, unless otherwise stated, pressure is given in cmH2O.

[0342] 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 at the current moment through the mask pressure Pm.

[0343] Respiratory pressure therapy (RPT): Applying air supply to the airway inlet at a therapeutic pressure that is typically positive relative to the atmosphere.

[0344] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0345] 5.1.1 Materials

[0346] 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.

[0347] Polycarbonate: a transparent thermoplastic polymer of bisphenol A carbonate.

[0348] 5.1.1.1 Mechanical properties

[0349] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0350] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain siloxanes and thermoplastic elastomers.

[0351] Hardness: The ability of a material to resist deformation (e.g., described by Young's modulus or an indentation hardness scale measured on a standardized sample size).

[0352] "Soft" materials can include silicone or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0353] "Hard" materials can include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0354] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. A structure or component can provide different resistance in different directions.

[0355] 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.

[0356] 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 and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway at a pressure of approximately 20 to 30 cmH2O.

[0357] 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.

[0358] 5.1.2 Respiratory and Circulatory Systems

[0359] Apnea: According to some definitions, apnea is considered to occur when the flow rate drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway prevents airflow even with patient effort. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0360] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0361] The expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0362] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0363] Openness (airway): The degree to which the airway is open or the degree to which the airway is open. An open airway is an open airway. Airway openness can be quantified, for example, with a value (1) for open and a value of zero (0) for closed (obstructed).

[0364] Ventilation: A measurement of the rate at which gases are exchanged by a patient's respiratory system. A measurement of ventilation can include one or both of inspiratory and expiratory flow rates (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.

[0365] 5.1.3 Anatomy

[0366] 5.1.3.1 Facial Anatomy

[0367] Auricle: The entire visible external part of the ear.

[0368] (Nose) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0369] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0370] 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.

[0371] The glabella (between the eyebrows): Located on the soft tissue, it is the most prominent point in the sagittal plane at the midline of the forehead.

[0372] Lower lip (midpoint of the lower lip): A point on the face between the mouth and the suprachin, located in the midsagittal plane.

[0373] Upper lip (midpoint of the upper lip): A point on the face between the mouth and nose, located in the midsagittal plane.

[0374] Nostrils (or nasal eyes): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostril (nare) is nasal nasal (naris). The nostrils are separated by the nasal septum.

[0375] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0376] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0377] 5.1.3.2 Anatomical Structure of the Skull

[0378] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0379] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0380] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw 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.

[0381] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary among individuals; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0382] 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.

[0383] 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.

[0384] The eye socket is the bony cavity in the skull that houses the eyeball.

[0385] Parietal bone: The parietal bone is the top and sides of the skull when joined together.

[0386] 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.

[0387] 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.

[0388] 5.1.3.3 Anatomical Structure of the Respiratory System

[0389] Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0390] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0391] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0392] Nasal chambers: The nasal chambers (or nasal fossae) are large, air-filled spaces located in the middle of the face above and behind the nose. The nasal chambers are divided into two parts by vertical wings called the nasal septum. On the sides of the nasal chambers are three horizontal branches called nasal conchae (singular "concha"). The front of the nasal chambers is the nose, while the back connects to the nasopharynx via the internal nasal openings.

[0393] Pharynx: The part of the throat located below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three segments: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0394] 5.1.4 Patient Interface

[0395] 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.

[0396] Elbow: An elbow is an example of a structure that guides the axis of an airflow traveling through it to change direction 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. An elbow can have an approximately circular cross-section. In another form, an elbow can have an elliptical or rectangular cross-section. In some forms, the elbow can rotate relative to the mating component, for example, about 360 degrees. In some forms, the elbow can be removable from the mating component, for example, via a snap-fit ​​connection. In some forms, the elbow can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0397] Frame: The frame is generally considered to refer to the mask structure that bears the tensile load between two or more points of connection with the head strap. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0398] Headband: A headband is considered to refer to a form of positioning and stabilization structure designed for use on the head. For example, a headband may include an assembly of one or more support bars, straps, and 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, resilient materials, such as laminated composites of foam and fabric.

[0399] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0400] Pressure chamber: A mask pressure 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 pressure chamber.

[0401] Sealing: can be the noun form referring to a structure (sealant) or the verb form referring to the effect (seal). Two elements can be constructed and / or arranged to 'seal' or to achieve 'sealing' between them, without the need for a separate 'sealing' element itself.

[0402] 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.

[0403] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0404] Support: The support will be considered as a structural component designed to increase the compressibility of another component in at least one direction.

[0405] Rotary shaft: (noun) a sub-component of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotating shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the rotating shaft may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assemblies of the component preferably comprise a pair of mating cylindrical ducts. During use, there may be little or no airflow leakage from the rotating shaft.

[0406] Lacing (noun: a structure used to resist tension).

[0407] Ventilation port: (noun): A structure that allows airflow from inside the mask or tubing to ambient air, for example, to effectively flush out exhaled gases. For example, clinically effective flushing can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute, depending on the mask design and treatment pressure.

[0408] 5.1.5 Shape of the structure

[0409] Products according to this technology may include one or more three-dimensional mechanical structures, such as mask pads or thrusters. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a surface that contacts the face (e.g., the exterior) and separate surfaces that do not contact the face (e.g., the underside or interior). In another example, a structure may include a first surface and a second surface.

[0410] To aid in describing the shape of three-dimensional structures and surfaces, we first consider a cross-section through a point p on the surface of the structure. The outward normal vector at point p is directed away from the surface. In some examples, the surface is described from the viewpoint of an imaginary little person standing upright on the surface.

[0411] 5.1.5.1 One-dimensional curvature

[0412] The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and a quantity (e.g., the reciprocal of the radius of the circle that only touches the curve at p).

[0413] Positive curvature: If the curve at point p turns outward toward the normal, then the curvature at that point will be positive (if you imagine little people leaving point p, they must walk uphill). Such curves are often called concave.

[0414] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if you imagine the little people leaving point p, they can walk horizontally without going up or down).

[0415] Negative curvature: If the curve at point p turns away from the outward normal, then the curvature in that direction at that point will be negative (if you imagine little people leaving point p, they must go downhill). Such curves are usually called convex curves.

[0416] 5.1.5.2 Curvature of Two-Dimensional Surfaces

[0417] A description of the shape at a given point on a two-dimensional surface according to the present invention may include multiple normal sections. These sections may cut through the surface in a plane including an outward normal (“normal plane”), and each section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has a quantity, for example, a relatively small quantity.

[0418] Principal curvature and principal direction: The direction of the normal plane where the curvature of the curve reaches its maximum and minimum values ​​is called the principal direction.

[0419] A region of a surface: a connected set of points on the surface. This set of points in a region can have similar characteristics, such as curvature or sign.

[0420] Saddle-shaped region: a region in which the principal curvature has opposite signs at each point, i.e., one sign is positive and the other sign is negative (which may be going up or down depending on the direction the imagined individual is turning).

[0421] Dome region: A region in which the principal curvature has the same sign at each point, such as two positive ("concave dome") or two negative ("convex dome").

[0422] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is not zero.

[0423] Planar region: A surface region in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0424] Surface edge: The boundary or limit of a surface or region.

[0425] Path: In some forms of this technique, 'path' will be considered to mean a path in a mathematical-topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, 'path' can be described as a route or distance, including, for example, a set of points on a surface. (The path of an imaginary person is the place where they walk on the surface, and is similar to a garden path).

[0426] Path length: In some forms of this technique, 'path length' will be considered as the distance along the surface from f(0) to f(1), i.e., the distance along the path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length for an imaginary person would be the distance they must walk along the path on the surface.)

[0427] Straight-line distance: Straight-line distance is the distance between two points on a surface, but without considering the surface itself. On a planar region, there will exist a path on the surface with the same path length as the straight-line distance between the two points on the surface. On a non-planar surface, there may not be a path with the same path length as the straight-line distance between the two points. (For an imaginary individual, straight-line distance will correspond to the distance as a 'straight line'.)

[0428] 5.1.5.3 Hole

[0429] Surfaces can have one-dimensional pores, such as pores defined by planar curves or spatial curves. Thin structures with pores (e.g., films) can be described as having one-dimensional pores.

[0430] The structure can have two-dimensional pores, such as pores defined by a surface. For example, an inflatable tire has two-dimensional pores defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have two-dimensional pores. In yet another example, a conduit can include a one-dimensional pore (e.g., at its inlet or outlet) and a two-dimensional pore defined by the inner surface of the conduit.

[0431] 5.2 Other Remarks

[0432] This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of these patent documents or patent disclosures by any person in the form they appear in the patent office documents or records, but otherwise reserves all copyright rights.

[0433] 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 may be included independently within the intermediate range and also within the scope of this technique, but are subject to any explicitly excluded boundaries within the range. Where a range includes one or both of the limit values, this technique also includes ranges that exclude any one or both of those included limit values.

[0434] Furthermore, where one or more values ​​described herein are implemented as part of this technique, it should be understood that such values ​​may be approximate unless otherwise stated, and such values ​​may be used to the extent permitted or required by the practical implementation of the technique for any appropriate valid digits.

[0435] Furthermore, as used herein, “about,” “substantially,” “approximately,” or any similar terms mean + / - 5 to + / - 10% of the stated value.

[0436] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While any methods and materials similar to or equivalent to those described herein may also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0437] When a particular material is determined to be used for constructing a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0438] It must be noted that, unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” used herein and in the appended claims include their plural equivalents.

[0439] 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.

[0440] 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.

[0441] The headings used in the detailed description are for the convenience of the reader only and should not be used to limit the subject matter found throughout this disclosure or the claims. These headings should not be used to interpret or limit the scope of the claims.

[0442] 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 not required for the practice of the techniques. For example, although the terms “first” and “second” may be used, they are not intended to indicate any order unless otherwise stated, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects may be performed simultaneously or even concurrently.

[0443] Therefore, it should be understood that many modifications can be made to the illustrative examples and other arrangements can be designed without departing from the spirit and scope of this technology.

[0444] 5.3 List of Reference Symbols

[0445]

Claims

1. A patient interface comprising: A sealing-forming structure is constructed and arranged to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, so as to deliver a pressurized airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use. The pressurization chamber can be pressurized to a treatment pressure at least 6 cmH2O higher than the ambient air pressure; as well as A positioning and stabilizing structure that provides forces to hold the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising: At least one gas delivery tube, connected to the pressurization chamber via an inlet port and configured to receive a pressurized airflow from a connection port on the top of the patient's head and deliver the pressurized airflow through the pressurization chamber to the inlet of the patient's airway, the at least one gas delivery tube being constructed and arranged to contact at least one region of the patient's head above a supraacus base point during use. The at least one gas delivery pipe includes a pipe wall forming an internal passage for delivering pressurized air along the longitudinal axis of the pipe to the sealing structure, wherein at least a portion of the pipe wall comprises: A patient contact portion includes an inner fabric material configured to contact the patient's head during use, the inner fabric material having a first elongated edge portion and a second elongated edge portion extending along the length of the inner fabric material; The non-patient contact portion includes an outer fabric material configured to be away from the patient's skin during use, the outer fabric material having a first elongated edge portion and a second elongated edge portion extending along the length of the outer fabric material; A first side portion, comprising silicone and disposed between the patient contact portion and the non-patient contact portion; The silicone on the first side is overmolded onto the first elongated edge portion of the inner fabric material and the first elongated edge portion of the outer fabric material, such that the silicone connects and spans the patient contact portion and the non-patient contact portion; and The silicone is transparent and / or translucent, thereby forming a first window segment to allow observation of the internal pathways through the silicone.

2. The patient interface of claim 1, wherein the silicone is configured as a rigid element to provide rigidity to the gas delivery tube.

3. The patient interface according to claim 1 or claim 2, wherein each gas delivery tube has a D-shaped profile.

4. The patient interface according to any one of claims 1 to 3, wherein in use, the first side is arranged along the front or rear side of the gas delivery tube.

5. The patient interface according to any one of claims 1 to 4, wherein each tube wall further comprises a second side portion comprising silicone and disposed between the patient contact portion and the non-patient contact portion.

6. The patient interface of claim 5, wherein the silicone on the second side is transparent and / or translucent, thereby forming a second window segment to allow observation of the internal pathways through the silicone on the second side.

7. The patient interface of claim 5, wherein the silicone on the second side is overmolded onto the second elongated edge portion of the inner fabric material and the second elongated edge portion of the outer fabric material, such that the silicone on the second side connects and spans the patient contact portion and the non-patient contact portion.

8. The patient interface according to claim 7, wherein in use, the first side is disposed along the front side of the gas delivery tube, and the second side is disposed along the rear side of the gas delivery tube.

9. The patient interface of claim 7, wherein the first side and the second side are configured such that the first side and the second side do not come into contact with the patient's face during use.

10. The patient interface of claim 7, wherein the wall of each gas delivery tube has a single-piece construction, the single-piece construction including the patient contact portion, the non-patient contact portion, the first side portion, and the second side portion.

11. The patient interface of claim 1, wherein the at least one gas delivery tube comprises a single gas delivery tube having a left arm and a right arm configured to extend along both sides of the patient's face in use.

12. The patient interface of claim 11, wherein the left arm and the right arm each have a tab configured to receive a corresponding end of a post-tracing bandage.

13. The patient interface of claim 11, wherein at least one inlet port comprises two inlet ports respectively disposed on opposite sides of the pressurization chamber.

14. The patient interface of claim 13, wherein each inlet port is configured to be connected to one of the left and right arms of the gas delivery tube.

15. The patient interface of claim 1, wherein the silicone on the first side has an inner surface forming a portion of an internal gas passage, the inner surface having a recess formed therein extending along the length of the gas delivery tube.

16. The patient interface of claim 15, wherein the recess is formed in the overlapping region of the gas delivery tube, and in the overlapping region, the silicone on the first side overlaps with the first elongated edge portion of the inner fabric material.

17. The patient interface of claim 1, wherein the inner fabric material and the outer fabric material each have an airtight layer applied thereon.

18. The patient interface of claim 1, wherein the first side portion includes an accordion-style section configured to extend the length of the gas delivery tube.

19. The patient interface of claim 1, wherein the thickness of the silicone on the first side varies along the length of the gas delivery tube.

20. The patient interface according to claim 1, wherein the sealing structure is a stent pad module.

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