Textile conduit including window

Abstract

To provide a medical device for diagnosing, improving, treating or preventing a respiratory disturbance, having one or more of improved comfort, improved cost, efficacy, ease of use and production possibility.SOLUTION: A positioning and stabilizing structure of a patient interface includes a gas delivery pipe comprising a pipe wall having an internal passage for flowing compressed air. A part of the pipe wall has a patient contact part and a non-patient contact part. The patient contact part includes a layer of a textile material or a foamed material which is mounted so as to face the head of the patient. The non-patient contact part includes a transparent / translucent material. A layer of the textile material or the foamed material is joined to the transparent / translucent material so that the pipe wall is formed as a one-piece structure. A plane extending in a traverse direction substantially to a longitudinal axis, includes both of (1) the textile material or the foamed material and (2) the transparent and / or translucent materials, therefore the patient may visually confirm the internal passage along a lateral axis extending through the plane.SELECTED DRAWING: Figure 3

Description

Technical Field

[0001] Part of the disclosure of this patent document contains content protected by copyright. The copyright owner has no objection if anyone reproduces this patent document or this patent disclosure by fax, provided that it is as described in the patent file or record of the Patent Office and for the intended purpose. However, for other purposes, all copyrights are retained.

[0002] 1 Cross - reference to related applications This application claims the benefit of Australian Provisional Patent Application No. 2019902272, filed on October 31, 2019. The entire content of this document is incorporated herein by reference in its entirety.

Background Art

[0003] 2 Background of the technology 2.1 Field of the technology This technology relates to one or more of the detection, diagnosis, treatment, prevention, and improvement of respiratory - related disorders. This technology also relates to medical devices or apparatuses and their use.

[0004] 2.2 Description of related technologies 2.2.1 The human respiratory system and its disorders The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0005] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The primary function of the lungs is gas exchange, which involves taking oxygen from the air into the venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchi make up the conducting airways and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory zone. See, e.g., "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0006] There are a range of respiratory disorders. Certain disorders can be characterized by specific events (e.g., apnea, hypopnea, and hyperpnea).

[0007] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events such as closure or obstruction of the upper airway during sleep. This is the result of a combination of an abnormally small upper airway and the normal loss of muscle tone in the tongue region, and the normal loss of the soft palate and posterior oropharyngeal wall during sleep. As a result of such a disorder, apneas in affected patients typically last from 30 to 120 seconds and sometimes occur 200 to 300 times per night. As a result, excessive daytime sleepiness can occur and it can cause cardiovascular disease and brain damage. This syndrome is a common disorder, particularly common in middle-aged overweight men, and patients are often asymptomatic. See U.S. Patent No. 4,944,310 (Sullivan).

[0009] Cheyne-Stokes respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of the patient's respiratory controller, in which alternating periods of increasing and decreasing ventilation, known as the CSR cycle, occur periodically. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to the repeated hypoxia, CSR can be harmful. In some patients, CSR is associated with repetitive sleep arousals that can cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0010] Respiratory insufficiency is a general term for respiratory disorders and refers to the inability of the lungs to perform adequate inspiration of oxygen or adequate CO 2 expiration. Respiratory insufficiency can include some or all of the following disorders.

[0011] Patients with respiratory insufficiency (a type of respiratory disorder) may experience abnormal shortness of breath during exercise.

[0012] Obesity hypoventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia during wakefulness in the absence of any other clearly identified cause of hypoventilation. Symptoms include dyspnea, headache upon waking, and excessive daytime sleepiness.

[0013] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These include an increased resistance to the movement of air, an extended expiratory phase of respiration, and a decrease in normal elasticity in the lungs. Examples of COPD are emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0014] Neuromuscular disorders (NMDs) are a broad term encompassing a number of diseases and conditions that impair muscle function either directly through intrinsic muscle pathology or indirectly through neuropathy. Among NMD patients, some are characterized by progressive muscle damage, which ultimately leads to inability to walk, wheelchair confinement, dysphagia, reduced respiratory muscle strength, and finally death due to respiratory failure. Neuromuscular disorders can be classified into the following rapidly progressive and slowly progressive types: (i) rapidly progressive disorders: characterized by muscle damage worsening over several months and leading to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in the 10s); (ii) variable or slowly progressive disorders: characterized by muscle damage worsening over several years and having a minor reduction in life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Respiratory insufficiency symptoms in NMDs include: increased general weakness, dysphagia, dyspnea during exertion and at rest, fatigue, drowsiness, headache upon waking, and difficulty with concentration and mood changes.

[0015] Chest wall disorders are a group of chest wall deformities that cause ineffectiveness of the connection between the respiratory muscles and the chest wall. These disorders are mainly characterized by restrictive disorders and share the possibility of long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis may develop severe respiratory failure. Respiratory insufficiency symptoms include: dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, headache upon waking, fatigue, reduced quality of sleep, and loss of appetite.

[0016] To treat or improve such diseases, a range of therapies are being used. Furthermore, in other aspects, even healthy individuals can advantageously utilize preventive therapies for respiratory disorders. However, these have several drawbacks.

[0017] 2.2.2 Therapies A variety of therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV)) are being used for the treatment of one or more of the above respiratory disorders.

[0018] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). As its mechanism of action, for example, by pushing the soft palate and tongue to move forward or backward against the posterior oropharyngeal wall, continuous positive airway pressure functions as an air pressure sprint, thereby preventing upper airway closure. Since the treatment of OSA by CPAP therapy can be spontaneous, if such a patient notices one or more of the following about the device used to provide the therapy, the patient may choose not to comply with the therapy: discomfort, difficulty of use, high cost, lack of aesthetic appeal.

[0019] Non-invasive ventilation (NIV) provides ventilatory assistance to a patient through the upper airway and performs part or all of the respiratory function to provide respiratory assistance to the patient and / or maintain an appropriate oxygen level in the body. The ventilatory assistance is provided via a non-invasive patient interface. NIV is used in the treatment of CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0020] Invasive ventilation (IV) provides ventilatory assistance to a patient who is unable to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0021] 2.2.3 Treatment System These therapies can be provided by a treatment system or device. Such systems and devices can also be used to diagnose a disease without treatment.

[0022] The treatment system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0023] 2.2.3.1 Patient Interface A patient interface may be used to provide an interface to a breathing apparatus to a wearer, for example, by providing an airflow to an airway inlet. The airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy applied, the patient interface may, for example, form a seal with the area of the patient's face, thereby providing a sufficient distributed pressure together with the ambient pressure for therapy execution (e.g., at a positive pressure that is about 10 cmH 2 O higher than the ambient pressure) to facilitate gas delivery. In other therapy modalities such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of gas supply to the airway at a positive pressure of about 10 cmH 2 O.

[0024] Certain other mask systems may be functionally inappropriate in the art. For example, in the case of a mask for purely decorative purposes, it may not be possible to maintain an appropriate pressure. A mask system used for underwater swimming or diving may be configured to protect against water ingress from higher external pressures and not maintain internal air at a pressure higher than the ambient.

[0025] Certain masks may be clinically unfavorable in the present technology (e.g., when the mask blocks airflow through the nose and only allows airflow through the mouth).

[0026] In certain masks, it may be uncomfortable or impractical in the present technology when the patient has to insert a part of the mask structure into the mouth and create and maintain a seal through the lips.

[0027] Certain masks may be impractical for use during sleep (e.g., when sleeping on the side in bed with the head on a pillow).

[0028] There are several challenges in the design of patient interfaces. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout a respiratory therapy session.

[0029] Due to these challenges, in some cases of masks, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more of the following reasons: overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of the wrong size is used, it can lead to a decrease in compliance, comfort, and patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic administration mask can withstand their original uses, but in such cases of masks, they can be unacceptably uncomfortable for long-term (e.g., several hours) wearing. Due to such discomfort, the patient's compliance with therapy may decrease. This is especially true when the mask needs to be worn during sleep.

[0030] CPAP therapy is extremely effective in the treatment of certain respiratory disorders when the patient is committed to the therapy. If the mask is uncomfortable or difficult to use, the patient may not commit to the therapy. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which can affect the patient's compliance.

[0031] Masks designed for the treatment of sleep apnea may be suitable for other uses in some cases, as masks for other uses (e.g., pilots) may not be suitable for the treatment of sleep apnea.

[0032] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0033] 2.2.3.1.1 Seal-forming structure The patient interface may include a seal-forming structure. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the seal-forming structure can have a direct impact on the effectiveness and comfort of the patient interface.

[0034] The patient interface can be characterized in part according to the design intent of where the seal-forming structure engages the face during use. In one form of the patient interface, the seal-forming structure can include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure can include a single element that surrounds both nostrils during use. Such a single element can be designed to rest, for example, on the upper lip region and nasal muscle region of the face. In one form of the patient interface, the seal-forming structure can include an element that surrounds the oral region by forming a seal, for example, on the lower lip region of the face during use. In one form of the patient interface, the seal-forming structure can include a single element that surrounds both nostrils and the oral region during use. These different types of patient interfaces may be known by various names such as nasal masks, full-face masks, nasal pillows, nasal puffs, and oro-nasal masks by their manufacturers.

[0035] A seal-forming structure that may be effective in one region of the patient's face may be inappropriate in another region, for example, due to different shapes, structures, variabilities, and sensitive regions of the patient's face. For example, the seal of a swimming goggle placed on the patient's forehead may be inappropriate for use on the patient's nose.

[0036] A particular seal-forming structure can be designed for mass production such that one design is suitable for a wide range of different face shapes and sizes and is comfortable and effective. To form a seal, it is necessary to conform one or both of the shape of the patient's face and the seal-forming structure of the mass-produced patient interface to the extent of any mismatch between them.

[0037] One type of seal-forming structure extends around the perimeter of the patient interface and is intended to seal the patient's face when a force is applied to the patient interface with the seal-forming structure engaged against the patient's face. This seal-forming structure can include an air or fluid-filled cushion or can include a shaped or formed surface of an elastic sealing element composed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inappropriate, a gap can occur between the seal-forming structure and the face, and additional force is required to press the patient interface against the face to achieve a seal.

[0038] Another type of seal-forming structure uses a thin flap seal positioned around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previously described type of seal-forming portion, if the alignment between the face and the mask is not good, additional force may be required to achieve a seal or leakage may occur from the mask. Further, if the shape of the seal-forming structure does not conform to the patient's shape, creases or buckling can occur during use, causing leakage.

[0039] Another type of seal-forming structure can include friction fit elements that are inserted, for example, into the nostrils, although there are patients who find these uncomfortable.

[0040] Another form of seal-forming structure can use an adhesive portion to achieve a seal. There are also patients who always find it inconvenient to attach or remove the adhesive portion to their face.

[0041] Regarding the technology of a patient interface seal formation structure within a certain range, there is a disclosure in the following patent applications assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; and WO2010 / 135,785.

[0042] One form of nasal pillows can be found in the Adam circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.) assigned to Puritan-Bennett Corporation.

[0043] ResMed Limited manufactures the following products using nasal pillows: SWIFT® Nasal Pillow Mask, SWIFT® II Nasal Pillow Mask, SWIFT® LT Nasal Pillow Mask, SWIFT® FX Nasal Pillow Mask and MIRAGELIBERTY™ Full Face Mask. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: International Patent Application WO2004 / 073,778 (describing in particular the appearance of ResMed Limited's SWIFT® nasal pillow), U.S. Patent Application No. 2009 / 0044808 (describing in particular the appearance of ResMed Limited's SWIFT® LT nasal pillow); International Patent Applications WO2005 / 063,328 and WO2006 / 130,903 (describing in particular the appearance of ResMed Limited's MIRAGE LIBERTY™ Full Face Mask); International Patent Application WO2009 / 052,560 (describing in particular the appearance of ResMed Limited's SWIFT® FX nasal pillow).

[0044] 2.2.3.1.2 Positioning and Stabilization The seal formation structure of the patient interface used in positive pressure air therapy is subject to the corresponding forces of air pressure that interfere with the seal. Therefore, various techniques are used to position the seal formation structure and maintain the seal against the appropriate parts of the face.

[0045] In one technique, an adhesive portion is used. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, when using an adhesive portion, there may be discomfort.

[0046] In another technique, one or more straps and / or a stabilization harness are used. In the case of a number of such harnesses, one or more of the following may apply: poor fit, bulky, uncomfortable, and difficult to handle.

[0047] 2.2.3.1.3 Pressurized air conduit In one type of treatment system, a pressurized air flow is provided to a patient interface through a conduit in an air circuit that is fluidly connected to the patient interface. When the patient interface is positioned on the patient's face during use, the conduit extends forward from the patient interface in a direction away from the patient's face. This may also be referred to as an "elephant trunk" type interface.

[0048] Some patients consider such an interface to be unsightly, and as a result, they stop wearing the interface, leading to reduced patient compliance. Further, when connecting the conduit to the interface in front of the patient's face, there is a high possibility of it getting caught in bedding.

[0049] 2.2.3.1.4 Pressurized air conduit used for positioning / stabilizing a seal-forming structure Another type of treatment system attempting to address these problems includes a patient interface. Within this patient interface, a tube for delivering pressurized air to the patient's airway also functions as part of a structure (also called a "headgear") that positions and stabilizes the seal-forming portion of the patient interface against an appropriate part of the patient's face. This type of patient interface can be referred to as one that employs "headgear tubing" or "tubing headgear". Such a patient interface enables a conduit within an air circuit that provides a pressurized air flow from a respiratory pressure therapy device to be connected to the patient interface at a location other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication No. 2007 / 0246043, which is incorporated herein by reference. In that document, the conduit is connected to a tube within the patient interface through a port positioned at the top of the patient's head.

[0050] In Philips' DreamWear™ mask, such headgear tubing is included. The length of this DreamWear™ headgear tube is non-adjustable. Therefore, the DreamWear™ headgear is supplied in three different sizes to accommodate different-sized patient faces. Providing a larger number of different sizes can increase the complexity and cost in headgear manufacturing and may lead to larger packaging. Further, when supplying masks of different sizes, the range capable of accommodating different-sized patient heads may be narrowed. If a patient can only choose from separate sizes with non-adjustable lengths, there is a high likelihood that the patient may not be able to achieve what the patient considers to be a "perfect" fit.

[0051] In the case of a patient interface employing headgear tubing, there can be several advantages (for example, the state where the conduit is connected to the patient interface in front of the patient's face, which state may be unsightly and too conspicuous, is avoided). However, when the patient is asleep, it is desirable for the patient to wear a patient interface employing headgear tubing more comfortably for a longer period (while forming an effective seal against the patient's face).

[0052] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device The respiratory pressure therapy (RPT) device can be used for the delivery of one or more of the above-described treatments, for example, by generating an air flow delivered to an inlet to the airway. This air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0053] Air pressure generators are known in a wide range of applications (for example, industrial-scale ventilation systems). However, air pressure generators for medical use have specific requirements that cannot be satisfied by more general air pressure generators (for example, the reliability requirements, size requirements, and weight requirements of medical devices). In addition, even a device designed for medical treatment may not be free from defects related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0054] The device designer can be presented with countless options. Since the design criteria often conflict with each other, certain design options may be far from convention or unavoidable. Furthermore, the comfort and effectiveness of a particular aspect can also be greatly affected by minor changes in one or more parameters.

[0055] 2.2.3.3 Humidifier When delivering an air flow without humidification, it can lead to drying of the airway. When a humidifier is used with an RPT device and a patient interface, humidified gas is generated, minimizing drying of the nasal mucosa and increasing patient airway comfort. Additionally, in a cooler climate, generally adding warm air to the facial area around the patient interface increases comfort compared to cold air.

[0056] A range of artificial humidification devices and systems are known, but they do not meet the special requirements of medical humidifiers.

[0057] Medical humidifiers are typically used to increase the humidity and / or temperature of an air flow relative to the ambient air when the patient is asleep or at rest (e.g., in a hospital), if necessary. A medical humidifier placed near the patient's head may be small. A medical humidifier may be configured to humidify and / or heat only the air flow delivered to the patient, and not humidify and / or heat the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air taken into the patient's body by breathing, but in the case of these systems, since they also humidify and / or heat the entire room, it can be uncomfortable for the occupants. Additionally, in the case of medical humidifiers, safety constraints may be more stringent than those of industrial humidifiers.

[0058] Although many medical humidifiers are known, such medical humidifiers can suffer from one or more defects. That is, in the case of such medical humidifiers, some may have inappropriate humidification, while others may be difficult or inconvenient for patients to use.

[0059] 2.2.3.4 Ventilation technology Some forms of treatment systems may include a ventilation section for pushing out exhaled carbon dioxide. This ventilation section can enable gas flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside (e.g., the surroundings) of the patient interface.

[0060] This vent may include an orifice through which gas can flow during mask use. In the case of a large number of such vents, it can be noisy. In other cases, it may become blocked during use, resulting in insufficient extrusion. In the case of some vents, for example due to noise or airflow concentration, it may interfere with the sleep of patient 1000 and co-sleeper 1100.

Summary of the Invention

Means for Solving the Problems

[0061] 3 Brief Description of the Technology This technology is related to the provision of medical devices used in the diagnosis, improvement, treatment, or prevention of respiratory disorders, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0062] The first aspect of this technology is related to a device used in the diagnosis, improvement, treatment, or prevention of respiratory disorders.

[0063] Another aspect of this technology is related to a method used in the diagnosis, improvement, treatment, or prevention of respiratory disorders.

[0064] One aspect of a specific form of this technology is to provide a method and / or device for improving patient compliance with respiratory therapy.

[0065] One aspect of this technology includes a patient interface for delivering a supply of pressurized breathable gas to the entrance of a patient's airway.

[0066] Another aspect of this technology relates to a patient interface. This patient interface is constructed and arranged to form a seal with the region of the patient's face that surrounds the entrance to the patient's airway for delivering a pressurized air flow at a treatment pressure that is at least 6 cmH 2 O higher than ambient air pressure during the entire patient breathing cycle; at least 6 cmH higher than ambient air pressure 2A plenum chamber capable of pressurizing up to a high treatment pressure; and a positioning and stabilization structure that provides a force for holding the seal formation structure in a therapeutically effective position on the patient's head.

[0067] Another aspect of the present technology relates to a patient interface. This patient interface includes a plenum chamber; a seal formation structure; a ventilation structure; a positioning and stabilization structure that provides a force for holding the seal formation structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including at least one gas delivery tube that receives an air flow from a connection port and delivers the air flow to the inlet of the patient's airway through the seal formation structure, the gas delivery tube being constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head during use.

[0068] According to one aspect of the present technology, there is provided a positioning and stabilization structure that provides a force for holding the seal formation structure in a therapeutically effective position on the patient's head. The seal formation structure is constructed and arranged to form a seal with a region of the patient's face that surrounds the inlet to the patient's airway at a treatment pressure that is at least 6 cmH 2 higher than the ambient air pressure throughout the patient's respiratory cycle, and the positioning and stabilization structure includes at least one gas delivery tube that receives an air flow from a connection port on the patient's head and delivers the air flow to the inlet of the patient's airway through the seal formation structure, the gas delivery tube being constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head during use, the gas delivery tube including a tube wall that defines a hollow interior through which air flows into the seal formation structure, the tube wall including: a patient contact portion including a first outer layer including a textile material or a foamed material configured to be placed facing the patient's head during use; and a non-patient contact portion including a second outer layer including a textile material or a foamed material on the opposite side of the first outer layer of the gas delivery tube.

[0069] According to one aspect of the present technology, a positioning and stabilization structure is provided that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure is constructed and arranged to form a seal with the area of the patient's face that surrounds the entrance to the patient's airway at a therapeutic pressure of at least 6 cmH 2 O higher than ambient air pressure for delivering air flow in a sealed manner throughout the patient's respiratory cycle. The positioning and stabilization structure includes at least one gas delivery tube for receiving air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to the entrance of the patient's airway. The gas delivery tube is constructed and arranged to contact at least one area of the patient's head above the upper ear base point of the patient's head during use. The gas delivery tube includes a tube wall that defines a hollow interior through which air flows into the seal-forming structure. At least a portion of the tube wall includes: a patient contact portion including a layer of textile material or foam material configured to be placed facing the patient's head during use; and a non-patient contact portion, at least a portion of which includes a transparent material.

[0070] According to one aspect of the present technology, the patient interface includes a seal-forming structure constructed and arranged to form a seal with the area of the patient's face that surrounds the entrance to the patient's airway for delivering pressurized air flow at a therapeutic pressure of at least 6 cmH 2 O higher than ambient air pressure throughout the patient's respiratory cycle; a plenum chamber capable of being pressurized up to a therapeutic pressure of at least 6 cmH 2 O higher than ambient air pressure; and a positioning and stabilization structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure is configured to deliver air flow at a therapeutic pressure of at least 6 cmH 2Constructed and arranged to form a seal with an area of the patient's face that surrounds the entrance to the patient's airway for delivery at high therapeutic pressures, the positioning and stabilization structure is Connected to a plenum chamber and configured to receive a pressurized air flow from a connection port above the patient's head and to deliver the pressurized air flow through the plenum chamber to the entrance of the patient's airway, at least one gas delivery tube, the at least one gas delivery tube being constructed and arranged to contact at least one area of the patient's head above the upper ear base point of the patient's head in use, the at least one gas delivery tube including a tube wall having an internal passage for moving the pressurized air flow along the longitudinal axis of the tube to the seal-forming structure, at least a portion of the tube wall being A patient contact portion including a layer of textile material or foam material configured to be placed opposite the patient's head in use; and A non-patient contact portion, at least a portion of the non-patient contact portion including a transparent and / or translucent material that allows visual inspection of the passage from the outside, the non-patient contact portion, The layer of textile material is joined to the transparent and / or translucent material such that the tube wall is formed as a one-piece structure; A plane generally extending transverse to the longitudinal axis includes both (1) the textile material or foam material and (2) the transparent and / or translucent material, whereby the patient can visually inspect the passage along a transverse axis extending through the plane.

[0071] In an example, the patient contact portion may include more than one layer. In these examples, the patient contact portion may include an outer layer of textile material or foam material configured to be placed opposite the patient's head in use and at least a first inner layer of thermoplastic material that forms at least a portion of the air passage within the at least one gas delivery tube. The first inner layer is joined to the outer layer.

[0072] In an example, the patient contact portion includes a single layer of a textile material or a foam material. In these examples, (a) the material properties of the textile material or its foam material are impermeable; and / or (b) the textile material or the foam material is coated with an impermeable substance along at least one surface to form the inner surface of at least one gas delivery tube configured to contact a pressurized gas flow.

[0073] In an example, the textile material or the foam material may include: (a) a blend of polyamides (e.g., nylon, polyester, and / or spandex); (b) a blend of polyamides (e.g., one or more laminate coats of nylon, polyester, and / or spandex and silicone). In this example, the thickness of each laminate coat of silicone may be from 5 to 75 microns. In a further example, the thickness of each laminate coat of silicone may be from 20 to 30 microns, and preferably may be 25 microns.

[0074] In an example, the patient contact portion may include a portion of a transparent and / or translucent material, and a part of the portion of the transparent and / or translucent material is configured to receive the textile material or the foam material. In these examples, the portion of the transparent and / or translucent material of the non-patient contact portion includes an adhesive layer configured to be joined to the textile material or the foam material.

[0075] In an example, the non-patient contact portion may include a portion configured to receive a portion of a transparent and / or translucent material. In an example of the present technology, the textile material or the foam material of the non-patient contact portion may include: (a) an adhesive layer configured to be joined to the portion of the transparent and / or translucent material; or (b) a layer of hook-and-loop material configured to cooperate and engage with a complementary layer of hook-and-loop material joined to the portion of the transparent and / or translucent material.

[0076] In an 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 can be joined; or (b) a layer of hook-and-loop material configured to cooperate and engage with a complementary layer of hook-and-loop material joined to the other of the patient contact portion or the non-patient contact portion.

[0077] In an example, the non-patient contact portion can include two additional layers. In these examples, the non-patient contact portion can include an outer layer of a transparent and / or translucent material and at least a first inner layer of a thermoplastic material that defines at least a portion of an air path within at least one gas delivery tube.

[0078] In an example, at least a portion of the transparent and / or translucent material is configured as: (a) a stiffening element; and / or (b) includes a concertina portion; and / or (c) includes a series of corrugated structures. In this example, (a) a textile material or a foam material is overmolded onto the concertina portion; (b) a textile material or a foam material is provided on the patient contact portion and configured to contact the patient; and / or (c) a textile material or a foam material is provided on the non-patient contact portion.

[0079] In one example of the present technology, the portion of the transparent and / or translucent material can extend substantially at least the length of one gas delivery tube. In another example of the present technology, the portion of the transparent and / or translucent material can extend only a portion of the length of one gas delivery tube. In yet another example of the present technology, the transparent and / or translucent material can be arranged as separate portions, each portion being separated along the length of at least one gas delivery tube by a portion of a non-transparent and / or translucent material (e.g., a textile material or a foam material).

[0080] In one example, the patient contact portion and the non-patient contact portion can each be elongate in shape and include a front-facing side (the front side of at least one gas delivery tube during use) and a rear-facing side (the rear side of at least one gas delivery tube during use) when in use. The front and rear sides of each of the patient contact portion and the non-patient contact portion are joined along the length of at least one gas delivery tube. In this example, at least one or both of the front and rear sides of the non-patient contact side include a transparent and / or translucent material.

[0081] In this example, the front side of the non-patient contact portion can have a different rigidity than the rear side; (a) the front side of the non-patient contact portion can be more rigid than the rear side of the non-patient contact portion; (b) the rigidity of the front side of the non-patient contact portion and / or the rear side of the non-patient contact portion can vary along the length of at least one gas delivery tube; (c) the rigidity of the front side of the non-patient contact portion and / or the rear side of the non-patient contact portion can be higher at the lower part of at least one gas delivery tube than at the upper part of at least one gas delivery tube.

[0082] In an example, the transparent and / or translucent material portion of the second outer layer can be formed from an elastomer, and the elastomer can be one or more of the following: a) silicone; b) thermoplastic elastomer (TPE); or c) thermoplastic polyurethane (TPU).

[0083] In further examples: (a) the patient contact portion and / or the non-patient contact portion may be shaped by thermoforming; (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 substantially rectangular cross-section with two or more curved corners; (d) the width of at least one gas delivery tube may vary from 34 mm to 18 mm along the length of at least one gas delivery tube; (e) the height of at least one gas delivery tube may vary from 8 mm to 6 mm along the length of at least one gas delivery tube, and / or (f) the non-patient contact portion may include only a transparent material. In these examples, (i) the D-shaped cross-section includes a substantially flat surface and an arcuate surface, the flat surface forms the patient contact portion, and the arcuate surface forms the non-patient contact portion; (ii) the arcuate surface includes a first portion and a second portion, the first portion is constructed from a transparent and / or translucent material, and the second portion is constructed from a textile material or a foam material; and / or (iii) the first portion is directly connected to the flat surface, and the second portion is disposed on the side opposite the flat surface.

[0084] In an example, the manufacturing method includes positioning a textile material or a foam material within a mold; introducing a transparent and / or translucent material into the mold; joining the transparent and / or translucent material to the textile material and / or the foam material to form at least one gas delivery tube; and connecting at least one gas delivery tube to a plenum chamber and / or a seal-forming structure. In these examples, (a) the mold includes a semi-circular protrusion, the transparent and / or translucent material flows around the semi-circular protrusion, and a semi-circular recess is generated along the hollow interior; and / or (b) the semi-circular protrusion directs the transparent and / or translucent material towards the textile material or the foam material, enabling joining between the transparent and / or translucent material and the textile material or the foam material, after which the non-patient contact portion is formed.

[0085] According to one aspect of the present technology, a positioning and stabilization structure is provided that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head. The seal-forming structure is constructed and arranged to form a seal with the region of the patient's face that surrounds the entrance to the patient's airway during use to deliver air flow at a therapeutic pressure that is at least 6 cmH 2 higher than the ambient air pressure throughout the patient's respiratory cycle, and the positioning and stabilization structure includes at least one gas delivery tube for receiving air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to the entrance of the patient's airway. The at least one gas delivery tube is constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head during use. The at least one gas delivery tube includes a tube wall that defines a hollow interior through which air is adapted to flow into the seal-forming structure. At least a portion of the tube wall includes: a patient contact portion including an outer layer of a textile material or a foam material configured to be placed facing the patient's head during use; and a non-patient contact portion including at least a portion of a transparent material; a stiffening element that is a portion of the transparent material. In one example, the transparent material of the non-patient contact portion can be an elastomer, and the elastomer can be one or more of the following: a) silicone; b) thermoplastic elastomer (TPE); or c) thermoplastic polyurethane (TPU).

[0086] In one example of the present technology, the transparent portion can extend substantially at least the length of the at least one gas delivery tube. In another example of the present technology, the transparent portion extends only a portion of the length of the at least one gas delivery tube. In yet another example of the present technology, the transparent portions are arranged at regular intervals along the length of the at least one gas delivery tube.

[0087] In one example, the patient contact portion and the non-patient contact portion may each be in an elongated shape and include a side portion facing forward (the front side portion of at least one gas delivery tube during use) and a side portion facing backward (the rear side portion of at least one gas delivery tube during use) when in use. Each of the front side portions and the rear side portions of the patient contact portion and the non-patient contact portion are joined along the length of at least one gas delivery tube. In this example, at least one or both of the front side portion and the rear side portion on the non-patient contact side include a transparent material.

[0088] In one example, the stiffening element may be provided at one of the front edge portion and the rear side portion of at least one gas delivery tube.

[0089] In this example, the front side portion of at least one gas delivery tube may have a stiffness different from that of the rear side portion of at least one gas delivery tube; (a) the front side portion of at least one gas delivery tube may include a higher stiffness than the rear side portion of at least one gas delivery tube; (b) the stiffness of the front side portion of at least one gas delivery tube and / or the rear side portion of at least one gas delivery tube may vary along the length of at least one gas delivery tube; (c) the stiffness of the front side portion of at least one gas delivery tube and / or the rear side portion of at least one gas delivery tube may be made higher at the lower portion of at least one gas delivery tube than at the upper portion of at least one gas delivery tube.

[0090] In the example, the rigidity-imparting element is formed by: a) the thickness of the portion of the transparent material is thicker compared to the first portion of at least one gas delivery tube than the second portion of at least one gas delivery tube; b) the width of the portion of the transparent material is larger compared to the first portion of at least one gas delivery tube than the second portion of at least one gas delivery tube. In these examples, the first portion is the lower part of at least one gas delivery tube, and the second portion is the upper part of at least one gas delivery tube. In other examples, the first portion is the upper part of at least one gas delivery tube, and the second portion is the lower part of at least one gas delivery tube. In a further example, the first portion is the front side portion of at least one gas delivery tube, and the second portion is the rear side portion of at least one gas delivery tube, or the first portion is the rear side portion of at least one gas delivery tube, and the second portion is the front side portion of at least one gas delivery tube.

[0091] In the example, the non-patient contact side includes a front-facing side portion and a rear-facing side portion configured to face the front direction and the rear direction respectively during use. In these examples, (a) the front-facing side portion and the rear-facing side portion are each constructed from a transparent and / or translucent material; and / or (b) the transverse axis generally extends from the front direction to the rear direction and includes only the transparent and / or translucent material.

[0092] In one embodiment, at least one gas delivery tube is selectively connected to the plenum chamber and configured to be removable to enable the patient to clean the inside of the tube.

[0093] According to another aspect of the present technology, a positioning and stabilization structure is provided that provides a force for holding the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure is constructed and arranged to form a seal with the region of the patient's face surrounding the entrance to the patient's airway for delivering airtight at a therapeutic pressure that is at least 6 cmH 2 O higher than the ambient air pressure throughout the patient's breathing cycle, and the positioning and stabilization structure is Including at least one gas delivery tube for receiving an air flow from a connection port on a patient's head and delivering the air flow to an inlet of the patient's airway via a seal-forming structure, the at least one gas delivery tube being constructed and arranged to contact at least one region of the patient's head above the upper ear base point of the patient's head during use, the at least one gas delivery tube including a tube wall defining a hollow interior through which air is adapted to flow to the seal-forming structure, the at least one gas delivery tube, during use, Including an upper tube portion and a lower tube portion, The tube wall of the upper tube portion includes a patient contact portion including an elastomer and a non-patient contact portion including an elastomer, The tube wall of the lower tube portion includes a patient contact portion including a first layer of a textile material or a foam material configured to be placed facing the patient's head during use and a non-patient contact portion including a second outer layer, at least a part of the second outer layer including a transparent material.

[0094] In an example, the first layer of the textile material is one or more fabric materials of a) nylon; b) polyester; c) spandex.

[0095] In an example, the first layer of the textile material is a) joined to the second outer layer by adhesion; b) joined to the second outer layer by hook and loop material.

[0096] In one example, the first layer of the textile material is also provided on the upper tube portion.

[0097] In one example, the transparent material of the second outer layer can be an elastomer, and the elastomer is one or more of the following: a) silicone; b) thermoplastic elastomer (TPE); or c) thermoplastic polyurethane (TPU).

[0098] According to one aspect of the present technology, At least 6 cmH higher than the ambient air pressure 2A plenum chamber capable of being pressurized to a high treatment pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for breathing by a patient; A seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding the inlet to the patient's airway, the seal-forming structure having holes therein such that air flow is delivered at the treatment pressure to at least the inlet to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle; A positioning and stabilization structure according to any one of the above aspects; and A ventilation structure enabling a continuous gas flow exhaled by the patient to pass from the interior of the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use, a patient interface including the ventilation structure is provided, The patient interface is configured to allow the patient to breathe through the mouth from the surroundings when there is no pressurized air flow through the plenum chamber inlet port, or the patient interface is configured to leave the patient's mouth exposed.

[0099] Another aspect of some forms of the present technology is a system for the treatment of a respiratory disorder including a patient interface according to any one or more of the other aspects of the present technology, an air circuit, and a source of positive pressure air.

[0100] According to one aspect of the present technology, a method of manufacturing a positioning and stabilization structure that provides a force for holding a seal-forming structure in a therapeutically effective position on a patient's head is provided. The seal-forming structure maintains an air flow at least 6 cmH above ambient air pressure throughout the patient's breathing cycle during use 2Constructed and arranged to form a seal with the area of the patient's face that surrounds the entrance to the patient's airway for delivery at high therapeutic pressures, the positioning and stabilization structure is Including at least one gas delivery tube for receiving an air flow from a connection port on the patient's head and delivering the air flow through the seal-forming structure to the entrance of the patient's airway, the gas delivery tube being constructed and arranged to contact at least one area of the patient's head above the upper ear base point of the patient's head during use, the gas delivery tube including a tube wall that defines a hollow interior through which air is adapted to flow to the seal-forming structure, at least a portion of the tube wall including: A patient contact portion including an outer layer of a textile material or a foam material configured to be placed facing the patient's head during use; and A non-patient contact portion, at least a portion of the non-patient contact portion including a transparent material.

[0101] Another aspect of one form of the present technology is a patient interface molded or otherwise constructed with a peripheral shape that is complementary to the shape of the intended wearer.

[0102] An aspect of one form of the present technology is a method of manufacturing the device.

[0103] An aspect of a particular form of the present technology is an easy-to-use medical device for, for example, people who have not received medical training, people who are not very dexterous or lack insight, or people with limited experience using this type of medical device.

[0104] An aspect of one form of the present technology is a portable RPT device that is portable by a human (e.g., around the home).

[0105] An aspect of one form of the present technology is a patient interface that can be cleaned, for example, with soap and water in the patient's home, and no special cleaning equipment is required.

[0106] According to one aspect of the present technology, the patient interface includes: During use, a pressurized air flow is at least 6 cmH higher than the ambient air pressure throughout the patient's respiratory cycle 2 A seal-forming structure constructed and arranged to form a seal with an area of the patient's face that surrounds the entrance to the patient's airway in order to deliver it at a therapeutic pressure that is at least 6 cmH2O higher than the ambient air pressure; At least 6 cmH2O higher than the ambient air pressure 2 A plenum chamber that can be pressurized up to a therapeutic pressure that is at least 6 cmH2O higher than the ambient air pressure; and A positioning and stabilization structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0107] According to one aspect of the present technology, at least one gas delivery tube connected to the plenum chamber and configured to receive a pressurized air flow from a connection port above the patient's head and deliver the pressurized air flow through the plenum chamber to the entrance 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 the upper ear base point of the patient's head during use, the at least one gas delivery tube including a tube wall having an internal passage for moving the pressurized air flow along the longitudinal axis of the tube to the seal-forming structure, at least a portion of the tube wall including A patient contact portion including a layer of textile material or foam material configured to be placed opposite the patient's head during use; and A non-patient contact portion, at least a portion of the non-patient contact portion including a transparent and / or translucent material that allows visual inspection of the passage from the outside, The layer of textile material is joined to the transparent and / or translucent material such that the tube wall is formed as a one-piece structure; A plane extending generally transverse to the longitudinal axis includes both (1) the textile material or foam material and (2) the transparent and / or translucent material, whereby the patient can visually inspect the passage along a transverse axis extending through the plane.

[0108] Of course, some of the above aspects may form lower-level aspects of the present technology. Also, various combinations of various ones of the lower-level aspects and / or aspects can be made, which may also constitute further aspects or lower-level aspects of the present technology.

[0109] Other features of the present technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

Brief Description of the Drawings

[0110] 4 Brief Description of the Drawings The present technology is illustrated by way of non-limiting example in the accompanying drawings. In the drawings, like reference numerals include the following like elements:

[0111]

Figure 1A

Figure 1B

Figure 1C

Figure 2A

Figure 2B

Figure 2C

Figure 2D

Figure 3

Figure 4

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Mode for Carrying Out the Invention

[0112] 5 Detailed Description of Examples of the Present Technology Before further describing the present technology in detail, it should be understood that the present technology is not limited to the specific examples that may be described herein. It should also be understood that the terms used in the present disclosure are for the purpose of describing the specific examples described herein and are not limiting.

[0113] The following description is provided in connection with various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. Additionally, any single feature or combination of features in any of these examples can constitute a further example.

[0114] 5.1 Therapy In one form, the present technology includes a method for treating a respiratory disorder. The method includes the step of applying positive pressure to the entrance of the airway of patient 1000.

[0115] In a particular example of the present technology, an air supply at positive pressure is provided to the nasal passage of the patient via one or both of the nostrils.

[0116] In a particular example of the present technology, mouth breathing is restricted, limited, or prevented.

[0117] 5.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of a respiratory disorder. The apparatus or device can include an RPT device 4000 that supplies pressurized air to patient 1000 via an air circuit 4170 to a patient interface 3000.

[0118] 5.3 Patient Interface Referring to FIG. 3, a non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation portion 3400, and a form of a connection port 3600 for connection to an air circuit (e.g., the air circuit 4170 shown in FIGS. 1A - 1C). In this example, the seal-forming structure 3100 and the plenum chamber 3200 are provided by a cushion module 3150. In this example, the cushion module 3150 is a cradle cushion module. In other examples, the cushion module can be a nasal pillow cushion module or another type of cushion module.

[0119] If the patient interface cannot comfortably deliver the lowest level of positive pressure to the airway, the patient interface may be inappropriate for respiratory pressure therapy.

[0120] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH 2 2O higher than the ambient.

[0121] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH 2 2O higher than the ambient.

[0122] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH 2 2O higher than the ambient.

[0123] 5.3.1 Seal-forming structure In one aspect of the present technology, the seal forming structure 3100 can provide a target seal forming area and further provide a cushioning function. The target seal forming area is an area where sealing can occur in the seal forming structure 3100. The area where sealing actually occurs (i.e., the actual sealing surface) can vary daily by the patient in a given treatment session depending on a range of factors (e.g., the placement location of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face).

[0124] In one aspect, the target seal forming area is disposed on the outer surface of the seal forming structure 3100.

[0125] In a particular aspect of the present technology, the seal forming structure 3100 is composed of a biocompatible material (e.g., silicone rubber).

[0126] The seal forming structure 3100 according to the present technology can be composed of a soft, flexible, and elastic material (e.g., silicone).

[0127] In a particular aspect of the present technology, a system is provided that includes more than one seal forming structure 3100. Each seal forming structure 3100 is configured to accommodate different sizes and / or ranges of shapes. For example, the system can include one form of the seal forming structure 3100 suitable for a large-sized head rather than a small-sized head and another suitable for a small-sized head rather than a large-sized head.

[0128] 5.3.1.1 Sealing mechanism In one aspect, the seal forming structure includes a pressure-activated seal flange using a pressure assist sealing mechanism. In use, the pressure assist seal flange can readily respond to the system positive pressure within the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface. The pressure assist mechanism can act in conjunction with the elastic tension in the positioning and stabilization structure.

[0129] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., from about 0.25 mm to about 0.45 mm). This member extends around the peripheral length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral portion of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is a spring-like element or includes a spring-like element and functions to support the sealing flange so that it does not buckle during use.

[0130] In one form, the seal-forming structure may include a compression seal or a gasket seal. In use, the compression seal or the gasket seal is constructed and arranged to be in a compressed state, for example, due to elastic tension in a positioning and stabilizing structure.

[0131] In one form, the seal-forming structure includes a tension portion. In use, the tension portion is held in a taut state, for example, by an adjacent region of the sealing flange.

[0132] In one form, the seal-forming structure includes a region having an adhesive surface or an adherent surface.

[0133] In certain forms of the technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension portion, and a portion having an adhesive surface or an adherent surface.

[0134] In one form, the non-invasive patient interface 3000 includes a seal-forming structure. This seal-forming structure forms a seal on the bridge region or nasal sill region of the patient's face and on the upper lip region of the patient's face during use. In these forms, the seal-forming structure may be referred to as a nasal mask. This applies, for example, to the patient interface 3000 shown in FIG. 1B. By this seal-forming portion, the supply of air or breathable gas is delivered to both nostrils of the patient 1000 through a single orifice. This type of seal-forming structure may be referred to as a "nasal cushion" or "nasal mask". In some examples of the present technology, the positioning and stabilization structure 3300 shown in FIG. 3 or FIG. 4 may be used to hold the nasal cushion in a sealed position on the patient's face.

[0135] In one form, as shown, for example, in FIG. 3, the seal-forming structure 3100 is configured to form a seal around the nostrils and optionally against the upper lip of the patient 1000 during use. This type of seal-forming structure may be referred to as a "cradle cushion" or "subnasal mask". The shape of the seal-forming structure may be configured to conform to or closely follow the underside of the patient's nose (i.e., the outer shape and angle of the seal-forming structure may be substantially parallel to the nasolabial angle of the patient). In one form of the nasal cradle cushion, the seal-forming structure includes a bridge portion that defines two orifices. By each of these two orifices, air or breathable gas is supplied to a different one of the patient's nostrils during use. The bridge portion may be configured to contact or seal the columella of the patient during use. In some forms of the present technology, the seal-forming structure 3100 is configured to form a seal on the underside of the patient's nose (without contact with the nasal muscle region of the patient's nose). In some examples, the patient interface may include a seal-forming structure 3100 in the form of a cradle cushion as described in PCT Application No. PCT / AU2018 / 050289 (filing date: March 29, 2018). This document is incorporated herein by reference.

[0136] In one form, the patient interface 3000 includes a seal-forming portion. This seal-forming portion forms a seal over the patient's jaw region, nasolabial region, and cheek regions of the face during use. This applies, for example, to the patient interface 3000 shown in FIG. 1C. By this seal-forming portion, the supply of air or breathable gas is delivered to both the patient's nostrils and mouth through a single orifice. This type of seal-forming structure may be referred to as a "full-face mask". In some examples of the present technology, the positioning and stabilization structure 3300 shown in FIG. 3 or FIG. 4 may be used to hold the full-face cushion in a sealed position on the patient's face. Alternatively, the positioning and stabilization structure 3300 of FIG. 3 or FIG. 4 may be used with the patient interface 3000. The patient interface 3000 includes a nasal seal-forming structure in the form of a nasal cushion or nasal cradle cushion, and an oral seal-forming structure (which may be referred to as an "oral cushion" or "oral mask") configured to form a seal around the patient's mouth during seal use. In such a mask, air or breathable gas is supplied to the patient's nostrils and the patient's mouth through the orifice during use. This type of seal-forming structure 3100 may be referred to as an "oral-nasal cushion" in which separate seals are provided around the mouth and nose, or as an "ultra-small full-face cushion" in which nasal sealing occurs around or adjacent to the patient's nostrils. In one form, the nasal seal-forming structure and the oral seal-forming structure are formed as a single component. In some examples, the patient interface may include a seal-forming structure 3100 in the form of a cradle cushion as described in U.S. Patent No. 62 / 649,376. The entire content of this document is incorporated herein by reference for all purposes.

[0137] 5.3.2 Plenum Chamber The plenum chamber 3200 has a perimeter of a shape that is complementary to the surface profile of an average person's face in the region where a seal is formed during use. In use, the peripheral edge of the plenum chamber 3200 is positioned proximate to the adjacent surface of the face. The actual contact with the face is provided by the seal forming structure 3100. The seal forming structure 3100 can extend around the entire edge of the plenum chamber 3200 during use. In some forms, the plenum chamber 3200 and the seal forming structure 3200 are formed from a single homogeneous piece of material.

[0138] In certain forms of the technology, such as the patient interface 3000 of FIG. 3, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside of the pressurized volume defined by the plenum chamber. In such forms, therapy compliance can be improved because the pressure is often reduced and / or the comfort of the wearer is increased.

[0139] In certain forms of the technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). The use of a transparent material can reduce the constriction of the patient interface and can assist in improving compliance with therapy. The use of a transparent material can assist a clinician in verifying the placement and function of the patient interface.

[0140] In certain forms of the technology, the plenum chamber 3200 is composed of a translucent material. By using a translucent material, the constriction of the patient interface can be reduced and compliance with therapy can be assisted.

[0141] 5.3.3 Positioning and Stabilization Structure The seal formation structure 3100 of the patient interface 3000 of the present technology can be held in the sealed position by the positioning and stabilization structure 3300 during use. The positioning and stabilization structure 3300 can be referred to as a "headgear" because it engages with the patient's head to hold the patient interface 3000 in the sealed position.

[0142] In one form, the positioning and stabilization structure 3300 provides a holding force sufficient to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0143] In one form, the positioning and stabilization structure 3300 provides a holding force sufficient to overcome the gravitational force on the patient interface 3000.

[0144] In one form, the positioning and stabilization structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tubing drag or accidental interference with the patient interface).

[0145] In one form of the present technology, a positioning and stabilization structure 3300 configured to be worn by the patient during sleep is provided. In one example, the positioning and stabilization structure 3300 has a non - obtrusive outer shape or cross - sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross - section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0146] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured not to be overly large or bulky so as not to interfere with the patient when sleeping in the supine sleep position with the back of the patient's head resting on a pillow.

[0147] In one aspect of the present technology, a positioning and stabilization structure 3300 is provided that is configured not to be overly large or bulky such that it would be an impediment when a patient lies in a lateral sleeping position with the patient's head resting on the side region of the patient's head on a pillow.

[0148] In one aspect of the present technology, the positioning and stabilization structure 3300 includes a release portion disposed between a front side portion of the positioning and stabilization structure 3300 and a rear side portion of the positioning and stabilization structure 3300. This release portion is not resistant to compression and can be, for example, a flexible or flimsy strap. The release portion is constructed and arranged such that when a patient lies with the head on the pillow, the presence of the release portion can prevent a situation where force to the rear side portion is transmitted along the positioning and stabilization structure 3300 and the seal is obstructed.

[0149] In one aspect of the present technology, the positioning and stabilization structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one aspect, the foam is porous such that moisture (e.g., sweat) can pass through the strap. In one aspect, the fabric outer layer includes a loop material that engages with a hook material portion.

[0150] In a particular aspect of the present technology, the positioning and stabilization structure 3300 includes a strap that is stretchable (e.g., stretchable with elasticity). For example, the strap can be configured such that, during use, it is taut and directs a force to bring a seal-forming structure into close contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0151] It is understood that the tie is a structure designed to withstand tension. During use, the tie can be part of the positioning and stabilization structure 3300 under tension. As described below, elasticity is added to some ties due to this tension. The tie can have a function of maintaining the seal-forming structure 3100 in a therapeutically effective position on the patient's head.

[0152] In one aspect of the present technology, the positioning and stabilization structure includes a first tie. The first tie is constructed and arranged such that, in use, at least a portion of its lower edge moves upward and passes over the upper ear base point of the patient's head, covering a portion of the parietal bone without covering the occipital bone. The first tie may be provided as part of a patient interface that includes, for example, a cradle cushion, a nasal pillow, a nasal cushion, a full face cushion, or an oro-nasal cushion. For example, the positioning and stabilization structure 3300 of FIG. 3 includes the first tie in the form of a gas delivery tube 3350 placed on top of the patient's head. The gas delivery tube 3350 may also be known as a headgear tube 3350 to provide the function of a headgear.

[0153] In one aspect of the present technology suitable for a nasal mask or a full face mask, the positioning and stabilization structure includes a second tie. The second tie is constructed and arranged such that, in use, at least a portion of its upper edge passes below the lower ear base point on the lower side of the patient's head and covers the occipital bone of the patient's head or is placed below the occipital bone of the patient's head. The second tie may be provided as part of a patient interface that includes, for example, a cradle cushion, a nasal pillow, a full face cushion, a nasal cushion, or an oro-nasal cushion. For example, the positioning and stabilization structure 3300 of FIG. 3 includes the second tie in the form of a strap 3310 placed opposite the back of the patient's head.

[0154] In one aspect of the present technology suitable for a nasal mask or a full face mask, the positioning and stabilization structure includes a third tie constructed and arranged to interconnect the first tie and the second tie so as to reduce the tendency of the first tie and the second tie to move away from each other in a separating direction. Further, in some aspects, the positioning and stabilization structure includes a fourth tie. The fourth tie is constructed and arranged to interconnect the second tie and the third tie so as to reduce the tendency of the second tie and the third tie to move away from each other in a separating direction.

[0155] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a strap that is bendable and for example non-rigid. An advantage of this aspect is that the strap is more comfortable when the patient lies on their side during sleep. The positioning and stabilization structure 3300 of FIG. 3 includes a bendable strap 3310. The strap 3310 can be regarded as a back strap. The strap 3310 has sufficient flexibility to pass around the back of the patient's head (even under tension during use) and to be comfortably placed opposite the patient's head.

[0156] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilization structure 3300. Each positioning and stabilization structure 3300 is configured to provide a holding force for accommodating different sizes and / or ranges of shapes. For example, the system can include one form of the positioning and stabilization structure 3300 that is suitable for a large-sized head rather than a small-sized head and another form that is suitable for a small-sized head rather than a large-sized head.

[0157] 5.3.3.1 Headgear Tubing In some forms of the present technology, the positioning and stabilization structure 3300 includes one or more tubes 3350. These one or more tubes 3350 deliver pressurized air received from a conduit forming part of the air circuit 4170 to the patient's airway from the RPT device (e.g., through the plenum chamber 3200 and the seal-forming structure 3100). In the form of the present technology shown in FIG. 3, the positioning and stabilization structure 3300 includes two separate gas delivery tubes 3350 that deliver air from the air circuit 4170 to the seal-forming structure 3100. The tubes 3350 are an integral part of the positioning and stabilization structure 3300 of the patient interface 3000 and position and stabilize the seal-forming structure 3100 of the patient interface to the appropriate part of the patient's face (e.g., the nose and / or mouth). This enables the conduit of the air circuit 4170 that provides the pressurized air flow to be connected 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 people). Although the pair of tubes 3350 has several advantages (described below), in some examples, the positioning and stabilization structure 3300 includes only a single tube 3350 configured to be placed on one side of the patient's head. Straps or other stabilizing components may be provided on the other side of the patient's head between the upper end of the single tube 3350 and the seal-forming structure 3100 to balance the forces on the seal-forming structure 3100.

[0158] To deliver pressurized air from the air circuit 4170 to the patient's airway, air may be included and since the air can be sent through the headgear tubing 3350, the positioning and stabilization structure 3300 may be described as inflatable. In an inflatable positioning and stabilization structure 3300, it is understood that not all components of the positioning and stabilization structure 3300 need to be inflatable. For example, in the example shown in FIG. 3, the positioning and stabilization structure 3300 includes inflatable headgear tubing 3350 and non-inflatable straps 3310.

[0159] In certain forms of the technology, the patient interface 3000 may include a connection port 3600. The connection port 3600 is disposed adjacent to the upper, side, or rear portion of the patient's head. For example, in the form of the technology shown in FIG. 3, the connection port 3600 is disposed at the upper portion of the patient's head. In this example, the patient interface 3000 includes an elbow 3610 provided with the connection port 3600. Since the elbow 3610 can pivot relative to the positioning and stabilization structure 3300, the movement of the conduit connected to the connection port 3600 is decoupled from the positioning and stabilization structure 3300. The connection port may be configured as a fluid connection opening 3390 as shown in FIG. 4, within the headgear tubing 3350 or to a component to which the headgear tubing 3350 is connected as shown in FIG. 3. Additionally or alternatively, the conduit connected to the connection port 3600 may pivot relative to the elbow 3610. In the illustrated example, the elbow 3610 includes a swivel conduit connector. This swivel conduit connector includes a connection port 3600 to which the conduit of the air circuit 4170 can be connected, thereby enabling the conduit to rotate about its longitudinal axis relative to the elbow 3610. In the example of FIG. 4, the air circuit 4170 can be connected to the fluid connection opening. The elbow 3610 can be rotatably connected to the fluid connection opening or to a ring received within the fluid connection opening.

[0160] A patient interface in which the connection port 3600 is not positioned in front of the patient's face may be advantageous if it is considered that the patient would look unsightly and / or too conspicuous when the conduit is connected to the patient interface 3000 in front of the face. For example, when connecting the conduit to the patient interface 3000 in front of the face, there is a high possibility of entanglement with bedding or bed linen (especially when the conduit extends downward from the patient interface during use). By a form of technology using a patient interface in which the connection port is positioned in the vicinity of the upper part of the patient's head during use, it may be easier or more comfortable for the patient to lie down or sleep in one or more of the following positions: a lateral position or a transverse position; a supine position (i.e., a position in which the face is generally upward); and a prone position (i.e., a position in which the face is generally downward). Further, connecting the conduit in front of the patient interface can exacerbate a problem known as tubing drag, in which case undesirable resistance can occur on the patient interface from the conduit, which can cause the face to become dislodged.

[0161] In the form of the present technology shown in FIGS. 3 and 4, the positioning and stabilization structure 3300 includes two tubes 3350. Each tube 3350 is positioned on different sides of the patient's head during use and extends to the elbow 3610 at the upper part of the patient 1000's head across each cheek region above each ear (above the upper ear base point of the patient's head as shown in FIG. 2C). The reason why this form of technology can be advantageous is that when one of the tubes is compressed and the gas flow along the tube is blocked or partially blocked while the patient is sleeping in a lying position, the other tube remains open, so there is a point of supplying pressurized gas to the patient. In other examples of the present technology, the patient interface 3000 may include a different number of tubes (e.g., one tube, or three or more tubes). In one example, one tube 3350 is provided in the patient interface, and the single tube 3350 is positioned on one side of the patient's head (e.g., across one cheek region) during use, and the strap forms part of the positioning and stabilization structure 3300 and is positioned on the other side of the patient's head (e.g., across the other region) during use to assist in fixing the patient interface 3000 on the patient's head.

[0162] Alternatively, the positioning and stabilization structure may be provided as a single gas delivery tube having a left arm and a right arm as shown in FIG. 4. In the illustrated example, the connection port 3600 is provided on the upper side of the positioning and stabilization structure rather than being a separate connection module as in the example of FIG. 3.

[0163] In a particular form of the present technology, the patient interface 3000 is configured such that the connection port 3600 is generally positioned at the upper point of the patient's head. The connection port 3600 can be positioned in the sagittal plane and aligned with the upper ear base point in a plane parallel to the coronal plane. The upper ear base point is defined in FIG. 2C. In some forms of the present technology, the positioning and stabilization structure 3300 can be configured to be worn at different positions, whereby the connection port 3600 can be positioned in the vicinity of the upper part of the patient's head in the sagittal plane, 20 mm in front or 20 mm behind the upper ear base point.

[0164] As described above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle cushion. The seal-forming structure 3100 is generally placed under the nose and seals around the underside of the nose. The positioning and stabilization structure 3300 can be structured and arranged to pull the seal-forming structure 3100 against the patient's face under the nose by a rearward and upward (e.g., posterior superior) sealing force vector. By adding the sealing force vector in the posterior superior direction, a seal-forming structure 3100 can be facilitated that forms a good seal against both the underside of the patient's nose and the surface facing forward on the patient's face on either side of the patient's nose and upper lip.

[0165] In some examples, the positioning and stabilization structure 3300 can add a sealing force vector in the posterior superior direction at an angle of approximately 35° relative to the Frankfort horizontal of the patient (shown in FIG. 2D) during use. The upper portion of the tube 3350 (e.g., the portion of the tube 3350 above the strap 3310) can be oriented vertically, and the rear headgear strap 3310 can extend from the tube 3350 at an angle of approximately 35° relative to the Frankfort horizontal of the patient in the posterior inferior direction. In this particular setup, an angle θ of 125° is formed between the strap 3310 and the upper portion of the tube 3350 (where the strap 3310 connects to the tube 3350). In other examples, θ can be greater than 125° or less than 125°.

[0166] In the configurations of the technology shown in FIGS. 3 and 4, these two tubes 3350 are fluidly connected to each other and to the connection port 3600 at their upper ends. In FIG. 3, these tubes 3350 are separate tubes and are connected to the crown connector 3360. These tubes 3350 are indirectly connected to each other by the crown connector 3360 and can be disconnected, for example, for cleaning, storage, or replacement. In FIG. 4, these two tubes are integrally formed, and the connection port 3600 is provided as a fluid connection opening 3390 that is the connection destination of the circumferential elbow. In other examples where separate tubes that are indirectly connected are used, for example, each tube can be connected to a T-shaped conduit having two conduit arms that can each be connected to the tube 3350. The crown connector 3360 can include a third conduit arm. The elbow 3610 that can be included in the connection port 3600 is received within the fluid connection opening 3390 at the center of the crown connector 3360. The elbow 3610 can be received within a ring within the fluid connection opening 3390 and can be configured to pivot within this ring. The fluid connection opening 3390 can also be regarded as the connection port 3600 itself.

[0167] The length of each of the tubes 3350 taking the configuration of the technology shown in FIGS. 3 and 4 is 15 - 30 cm (for example, 20 - 27 cm each). The length of the tube is selected to be appropriate for the dimensions of a typical patient's head when following a generally arcuate path that extends downward from the head side portion and across the patient's cheek region (for example, the arcuate path taken by the tubes 3350 shown in FIGS. 3 and 4) (for example, the distance between the region near the upper part of the head (where the upper end of the tube 3350 is located) and the region near the opening to the patient's airway (where the lower end of the tube 3350 connects to the plenum chamber 3200)). In some examples, the patient interface 3000 can be configured such that the length of the tube 3350 is variable. It is understood that the length of the tube 3350 depends on the lengths of other components within the patient interface 3000 (for example, the length of the crown connector 3360 which is the connection destination of the upper end of the tube 3350 and / or the size of the plenum chamber 3200).

[0168] The cross-sectional shape of the gas delivery tube 3350 can be circular, elliptical, oval, D-shaped, trapezoidal, or rounded rectangular, such as described in U.S. Patent No. 6,044,844. This document is incorporated herein by reference. The cross-sectional shape showing the flat side of the tube facing and contacting the patient's face or other parts of the head may be more comfortable to wear than, for example, a tube with a circular cross-section.

[0169] The width and / or height of the cross-section of the tube 3350 can be in the range of 8 to 35 mm. In some forms, these tubes can have an approximately D-shaped cross-section, where the width of the tube can be in the range of 15 to 25 mm and the height can be in the range of 6 to 15 mm. This height can be considered the dimension of the tube extending away from the patient's face during use (i.e., the distance between the outermost parts of the patient contact portion 3348 and the non-patient contact portion 3349), and this width can be considered the dimension across the surface of the patient's head. The cross-sectional thickness of the material forming the tube 3350 can be in the range of 0.8 to 1.6 mm (e.g., 1.0 to 1.5 mm).

[0170] 5.3.3.1.1 Structure of the Gas Delivery Tube In an example of this technology, FIG. 5 shows a cross-section through a gas delivery tube 3350 having a substantially D-shaped outer profile. During use, the flat side of the outer profile contacts the patient's face and head and should be understood as the patient contact portion of the gas delivery tube. The raised or arcuate side of the outer profile should be understood as the non-patient contact portion of the gas delivery tube. In some examples, the gas delivery tube can have a more square or rectangular outer profile configured with slightly curved corners for patient comfort.

[0171] The gas delivery tube 3350 is at least substantially constructed of a textile material and / or a foamed material and a transparent material that at least substantially includes an elastomeric material. The transparency (i.e., light transmittance) of the elastomeric material enables see-through. In some examples, the transparency can be enhanced such that transmitted light is minimal or undeflected, whereby the transparency of the elastomeric material is similar to that of glass or a film. In other examples, the transparency can limit the deflection of transmitted light to a certain extent, and the transparency of the elastomeric material is slightly cloudy but sufficient for the patient to clearly detect dirt and mold.

[0172] In use, the gas delivery tube is constructed such that the patient contact portion of the gas delivery tube (i.e., the portion that contacts the patient's face and head) substantially includes a textile material. The transparent material includes at least a portion of the non-patient contact side of the gas delivery tube.

[0173] This structure makes it comfortable for the patient to wear the gas delivery tube as part of a positioning and stabilization structure and also enables inspection inside the gas delivery tube. That is, it may be possible to visually detect accumulations such as dirt or mold inside the gas delivery tube. The patient can disconnect the gas delivery tube 3350 from the plenum chamber 3200 to remove all of the detected residues inside. The transparent material enables the patient to confirm whether all dirt and mold have been removed when the gas delivery tube is being cleaned.

[0174] In a particular form of the present technology, the gas delivery tube 3350 is constructed of a translucent material. The use of a translucent material can function substantially the same as a transparent material and can be used in addition to or in place of a transparent material in any embodiment.

[0175] As a further advantage of this structure, since the textile material and the elastomeric material can be combined for an integrated appearance and feel, there is a high likelihood that a higher quality will be recognized compared to conventional gas delivery tubes constructed entirely of textile material or elastomeric material. Further, this integrated structure can enable cost reduction and weight reduction compared to conventional gas delivery tubes.

[0176] 5.3.3.1.2 Textile / Foam Material The flat side 3351 of the gas delivery tube 3350 forms the patient contact side of the gas delivery tube. This includes a textile material. In this example, the textile material can have at least two layers (i.e., an inner layer 3352 that includes a gas-impermeable layer (e.g., formed from a film or laminate of silicone or another elastomeric plastic material (e.g., TPE or TPE)) and an outer textile layer 3353 that forms the exterior of the gas delivery tube 3350). The inner layer 3352 is joined to the outer textile layer 3353. In some other examples, a further layer can be provided between the gas-impermeable layer and the outer textile layer (e.g., an intermediate adhesive layer that joins the gas-impermeable layer to the outer textile layer 3353). In a further example, the textile material can include a single layer. In these examples, since the textile material can be essentially gas-impermeable, a further film or laminate layer is not required.

[0177] In some examples of the present technology, such as the examples shown in FIGS. 3 and 4, the headgear tube 3350 includes a patient contact side that is at least partially formed of a textile material as described above. Additionally or alternatively, the patient contact side of the gas delivery tube 3350 can be formed from a foamed material. In some examples, the tube 3350 includes a combination of textile and foamed materials. By providing a textile and / or foamed material on the patient contact side of the gas delivery tube, the following can be enabled: air retention under pressure, suitability / approval for biocompatibility and use in forming a medical air pathway, being lighter than a silicone tube, having flexibility and flexibility, generally maintaining a predetermined shape, being cleanable and durable over a predetermined lifespan (e.g., 1 month, 3 months, 6 months, 1 year or more).

[0178] As described above, the non-patient contact portion of the gas delivery tube is formed by the arcuate side portion 3354 of the D-shaped outer shape. In one example, at least a portion of the non-patient contact portion is provided in the same manner as the patient contact side (i.e., a textile material having at least two layers (i.e., an inner layer including a gas-impermeable layer in which an elastomeric plastic material is joined to the outer textile layer)). However, in other examples, if the textile material that may include a part of the non-patient contact portion is made sufficiently gas-impermeable, the inner layer becomes unnecessary, and a single layer of textile material and a transparent material is included in the non-patient contact portion. To assist in maintaining the sharp shape, the textile material on the non-patient contact side 3354 can be stiffened (e.g., by adding a gas-impermeable layer, a stiffening material). Alternatively, a stiffening material may not be included, and an arcuate D-shaped shape can be formed only when pressurized air passes through the gas delivery tube 3350.

[0179] In one example, the textile material including the gas delivery tube can be a blend of polyamides (e.g., nylon, polyester, and / or spandex), and can have a weight of 50 g / m2 to 250 g / m2. In a further example, the textile material can be a material with a weight of 120 g / m2. In some examples, the inner layer of the textile material can include two or more laminate coats of silicone. In one example, the thickness of each laminate coat of silicone can be 5 to 75 microns. In a further example, the thickness of each laminate coat of silicone can be 20 to 30 microns, and preferably can be 25 microns.

[0180] It is advantageous to provide the textile on the outside of both the patient contact side and the non-patient contact side of the gas delivery tube. 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 the bed, the friction when the gas delivery tube contacts other textiles (e.g., pillow or bed linen) is reduced. By doing so, the feel and aesthetics are also more comfortable.

[0181] 5.3.3.1.3 Transparent Material - Window In the examples of FIGS. 5 and 6, the front side portion 3355 and the rear side portion 3356 of the D-shaped outer shape, where the patient contact side of the gas delivery tube 3350 and the non-patient contact side of the gas delivery tube 3350 meet, are formed of a transparent material. This transparent material forms a window in the outer shape of the gas delivery tube 3350, enabling the user to visually inspect the inside. This makes it easier to detect the accumulation of mold and / or dirt, promotes internal cleaning, and substantially maintains the comfort due to the outside of the textile.

[0182] In the examples of FIGS. 5 and 6, both the patient contact side 3351 and the non-patient contact side 3354 of the gas delivery tube 3350 are each formed from a single elongated strip of textile material. Further, the gas delivery tubes of FIGS. 5 and 6 are configured with two windows, one window being provided along each of the front side portion 3355 and the rear side portion 3356 of the gas delivery tube. In the illustrated example, the transverse axis TA can extend transversely with respect to the longitudinal axis LA through both the front side portion 3355 and the rear side portion 3356, generally extending along at least a portion of the gas delivery tube 3350 (e.g., along the interface between the plenum chamber 3200 and the positioning and stabilization structure 3300) in the flow direction of the pressurized air. The transverse axis may not pass through any of the elongated strips of the textile material. For example, the transverse axis can extend along the elongated strip of textile material forming the patient contact side 3351 in the forward / rearward direction, but does not intersect the elongated strip of textile material forming the non-patient contact side 3354. When the patient looks along the transverse axis TA, it may be possible to view the entirety through the gas delivery tube 3350. In other words, the gas delivery tube 3350 does not include an opaque material when viewed along the transverse axis TA. Since a clear line of sight along the transverse axis TA can be blocked by residue within the gas delivery tube 3350, the patient may be able to more clearly identify the residue. However, by providing both the textile and the transparent material along the perimeter of the gas delivery tube 3350, both the transparent material and the textile material are provided in a direction that is exposed to the patient (e.g., for visual inspection) from the transverse plane (i.e., the plane including the transverse axis TA) to the longitudinal axis LA (i.e., the cross-section shown in FIG. 5).

[0183] In each elongated strip of the textile material, opposing edges are provided along the long dimension; that is, the windows of the transparent material are joined to each edge of the patient contact side 3351 and the non-patient 3354 contact side by an adhesive technique or a heat welding technique. In other examples, the windows can be overmolded onto the edges of the textile material of the patient contact side 3351 and the non-patient 3354 contact side.

[0184] In other examples, the non-patient contact side 3354 can be formed from two or more elongate strips of a textile material with a transparent material dispersed therein. For example, the non-patient contact side 3354 can be formed from two elongate strips of textile material, which are separated by a single elongate strip of transparent material and joined or overmolded to each edge of the textile material. In addition to the windows 3355 and 3356 on either side of the D-shaped outer profile, a window is disposed at the center of the arcuate side of the D-shaped outer profile. In yet another example, the patient contact side and the non-patient contact side of the gas delivery tube are formed from a single elongate strip of textile material, and the edges of the textile material are positioned substantially at the center or alternatively on one side of the non-patient contact side 3354 of the D-shaped outer profile. In this example, the window is positioned between the long and narrow edges of the textile material. In other words, the transparent material is positioned (e.g., overmolded) between the long and narrow edges of the textile material, whereby the edges are not completely connected. In this example, the patient has only a single viewing window and cannot view completely through the gas delivery tube 3350.

[0185] In these examples, the transparent material forming the windows 3355 and 3356 is an elastomeric material. In one such example, the transparent material is a medical grade silicone. In some examples, the silicone can be selected from silicones having a Shore A durometer measurement range of 35 to 45 (i.e., soft to moderately soft). In a further example, the Shore A durometer measurement of the silicone is 38 to 42. In one such example, the Shore A durometer measurement of the silicone is 40.

[0186] In some examples, a harder durometer measurement can be used to increase the structural integrity of the gas delivery tube. However, in that case, there is also a higher possibility of an increase in pressure when the non-patient contact side unexpectedly contacts the patient's face during wearing of the positioning and stabilization structure. As a result, it can be uncomfortable for the patient.

[0187] In other examples, the transparent material can be a TPE or TPU of appropriate softness. The advantages of TPE are relatively low cost and a lower operating temperature. For example, the molding of TPE can be performed at a temperature below 50 °C with a shorter cycle time compared to elastomeric materials such as silicone.

[0188] In one example, the formation of the window portions 3355 and 3356 is performed by overmolding silicone onto an elongate piece of textile material, thereby forming the patient contact side 3351 and the non-patient contact side 3354, respectively. In some examples, after a gas-impermeable layer is formed by laminating or coating the textile material, the gas-impermeable layer becomes a cut elongate piece, but in other examples, these elongate pieces can be laminated after being knitted, for example, by warp knitting.

[0189] In one example of manufacture, an elongate piece of textile material is inserted into a mold and the window portions 3355 and 3356 are molded onto the textile material. Thereby, a one-piece structure can be formed between the textile material and the transparent material. In FIGS. 5 and 6, since the window portions 3355 and 3356 include a semi-circular outer shape 3357 on the hollow interior of the gas delivery tube, they can have a complementary shape to the outer shape 3357. This can assist in directing the flow of silicone during molding, thus facilitating bonding to the textile elongate piece, and then the portion forming the window is filled. Thereby, the textile elongate pieces on either side of the window are biased towards each other, resulting in a stronger bond. Conversely, the formation of the window can first bias the textile elongate pieces in the separating direction, which can affect the quality and appearance of the gas delivery tube.

[0190] In some examples, a portion of the length of the gas delivery tube can be configured with one or more windows, and in other examples, the entire length of the gas delivery tube 3350 can be configured with one or more windows 3355 and 3356. In further examples, the length of the gas delivery tube can be configured with a series of windows arranged at specific intervals and / or strategic positions. For example, in a particular configuration, one or more windows are provided at the lower part of the gas delivery tube 3350 near the plenum chamber 3200, while none are provided at the upper part of the gas delivery tube near the connection port to the air supply. In some of these examples, at least some of the individual windows can be separated from adjacent windows by portions of textile material or foam material.

[0191] 5.3.3.1.4 Transparent Material - Non-Patient Contact Side In a further example, FIG. 7 shows a gas delivery tube 3350 having a substantially D-shaped outer profile. The curved portion of the profile is the non-patient contact side 3354 of the gas delivery tube 3350 and can be entirely formed from a transparent material, and the flat portion of the profile is the patient contact side 3351 of the gas delivery tube and entirely includes a textile material or a foam material. The patient contact portion 3351 and the non-patient contact portion 3354 are joined at each flange, and these flanges form the front side portion and the rear side portion by the gas delivery tube 3350 during use, respectively.

[0192] In other examples, instead of the D-shaped outer profile of FIG. 7, the gas delivery tube can have a substantially square or rectangular outer profile (including curved corners for patient comfort). The curved corners can assist in reducing potential failure locations (e.g., locations where a failure can occur in the gas delivery tube 3350 due to repeated pressurization and depressurization) as opposed to sharp corners.

[0193] The arrangement configuration and the described example of FIG. 7 can be advantageous because the provided conduit headgear can be worn comfortably and at least a part of the interior of the gas delivery tube is visible to the patient (even if not the entire length). Inspection and cleaning of the gas delivery tube can be made easier. In other examples, only a part of the length on the non-patient contact side can be formed of a transparent material. For example, the transparent material can be included only on the non-patient contact side at the lower end of the gas delivery tube. In another example, the non-patient contact side at the upper end of the gas delivery tube can include a transparent material.

[0194] 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 can be selected from silicones having a Shore A durometer measurement range of 35 to 45 (i.e., from soft to moderately soft). In a further example, the Shore A durometer measurement of the silicone is 38 to 42. In one such example, the Shore A durometer measurement of the silicone is 40.

[0195] In other examples, the transparent material can be a TPE or TPU of appropriate softness. The harder the durometer measurement, the higher the likelihood of an increase in pressure when the non-patient contact side 3354 unexpectedly contacts the patient's face during wearing of the patient interface positioning and stabilization structure. As a result, it can be uncomfortable for the patient.

[0196] In this example, for patient comfort, the patient contact side 3351 of the gas delivery tube 3350 is constructed from an opaque textile material as described above. In FIG. 7, the textile layer includes an inner layer in the form of, for example, a gas-impermeable layer 3352 of a silicone laminate. In some examples, an additional layer of adhesive or an additional laminate layer can be provided. A flow path is formed between the inner gas-impermeable layer 3352 and the non-patient contact side 3354 which is medically compatible with a clean gas flow because it entirely includes an elastomeric material as described above in this example.

[0197] Additionally or alternatively, the patient contact side 3351 may be formed from or include a foamed material. In some examples, the tube 3350 may include a combination of a textile material and a foamed material. The textile and / or foamed material including the patient contact side 3351 of the gas delivery tube may enable the following: air retention under pressure, suitability / approval for biocompatibility and use in forming a medical air pathway, being lighter than a silicone tube, having flexibility and flexibility, generally maintaining a predetermined shape, and being cleanable and durable over a predetermined lifespan (e.g., 1 month, 3 months, 6 months, 1 year or more).

[0198] In some examples, the non-patient contact side 3354 of the gas delivery tube 3350 may at least partially include one or more concertina portions 3358 as shown in FIG. 8. Each concertina portion 3358 may include a part of the gas delivery tube 3350 having one or more fold portions, pleats, corrugated structures or bellows as described in PCT application No. PCT / AU2019 / 050874. This document is incorporated herein by reference for reference purposes.

[0199] In some examples, the concertina portion may extend only a part of the length of the non-patient contact side of the gas delivery tube as shown in FIG. 8, but in other examples, the concertina portion may extend the entire length of the non-patient contact side of the gas delivery tube. In a further example, the concertina portion 3358 may be disposed at strategic points along the length of the gas delivery tube. For example, the concertina portion may be disposed at points corresponding to the curves of the patient's head (e.g., around the crown and jaw, below the line of the mouth), but not on the substantially flat portion of the head (e.g., the side of the head between the upper and lower auricular points), thereby assisting in a positioning and stabilization structure that conforms to the shape of the patient's head.

[0200] In other examples, the concertina portion can extend partially around the non-patient contact side perimeter of the gas delivery tube. In an example, the concertina portion can extend to include the rear and front sides of the gas delivery tube. In a further example, the concertina portion can extend to surround the entire perimeter of the gas delivery tube. In this example, the concertina portion can include both the patient contact side and the non-patient contact side of the gas delivery tube. In this case, compared to other examples where the concertina portion extends only around or only a part of the non-patient contact side perimeter, the elongation function for increasing the length of the gas delivery tube can be higher.

[0201] In the examples of FIGS. 11 and 12, the concertina portion 3358 of the gas delivery tube 3350 comprises at least partially a textile material or a foam material and at least partially a transparent material (e.g., silicone, TPE or TPU as described above in the previous examples). In some examples, the textile material or the foam material can be provided only on the patient contact side of the gas delivery tube, so the non-patient contact side remains partially or entirely included of the transparent material. Since the stretch characteristics of the textile material and the transparent material can be similar, it becomes possible for both the patient side and the non-patient side to stretch together (e.g., the concertina does not become curved during stretching). However, in the examples of FIGS. 11 and 12, the non-patient contact side includes an elongate strip of textile material in the form of a textile pad 3308 that extends only the length of the gas delivery tube. In this example, the gas delivery tube 3350 is entirely included of the transparent material, and the textile pad 3308 is joined to the non-patient contact side of the gas delivery tube 3350 (e.g., by overmolding, adhesion). In other words, in this example, the textile material does not come into contact with the pressurized air as the pressurized air passes through the gas delivery tube 3350.

[0202] In some further examples, the concertina portion comprises both a non-patient contact side and a patient contact side. In this example, the patient contact side of the concertina portion can also include a textile material or a foam material for patient comfort.

[0203] The use of the gas delivery tube 3350 having one or more concertina portions enables a constant elongation and bending function in the gas delivery tube 3350, which can be advantageous in providing a conduit headgear that can better conform to the shape of the patient's head. For example, in FIG. 10, the upper portion of the gas delivery tube 3350 of the positioning and stabilization structure 3300 includes a concertina portion 3358. The advantage of this is that a certain degree of extensibility and / or bendability can be obtained in the gas delivery tube for fitting to the upper part of the patient's head.

[0204] As can be seen from FIG. 8, the concertina portion 3358 may include a series of external ridges 3359A and grooves 3359B. These external ridges 3359A and grooves 3359B are alternately formed along at least a part of the non-patient contact side 3351 of the gas delivery tube 3350. In some examples, corresponding ridges and grooves may be provided inside the gas delivery tube, but this may result in a compromise in manufacturing cost efficiency.

[0205] In some examples, the ridges 3359A and grooves 3359B provided alternately may function like a crease or bellows, and can be bent and unfolded independently or in cooperation, shortening or lengthening the concertina portion 3358 and thus each gas delivery tube 3350. Increasing the groove depth (or ridge height) can result in a more extensible or more bendable tube 3350. When tension is applied to the tube 3350, the ridges 3359A and grooves 3359B of the extensible concertina portion 3358 can be pulled in a direction away from each other, so that the tube wall becomes straight and the tube 3350 is lengthened. In this example, the concertina portion 3358 is biased to return to its original (e.g., non-extended) length. When the tension of the headgear is released, the ridges 3359A and grooves 3359B are biased to return to their original configuration. In this original configuration, the concertina portion 3358 and the tube 3350 have their original lengths. Thereby, the adaptation of the gas delivery tube to the shape of the patient's head can be assisted. Since the stretch or elongation of the concertina portion on the gas delivery tube 3350 can be substantially elastic, a similar force is provided to the plenum chamber 3200 each time of continuous use.

[0206] In other examples, the alternately provided ridges 3359A and grooves 3359B of the concertina portion can be formed as a corrugated structure, enabling deformation and bending of the gas delivery tube. In this example, the concertina portion may have a limited or no function of shortening or lengthening. The ridges 3359A and grooves 3359B can assist in changing the shape of the concertina portion 3358 of the gas delivery tube 3350, thereby assisting the adaptation of the gas delivery tube to the patient's head.

[0207] 5.3.3.1.5 Rigidity In some examples of the present technology, the gas delivery tube 3350 or a part of the gas delivery tube of the positioning and stabilization structure 3300 can be configured to have higher resistance in some directions or axes or around them than in other directions or axes. Providing relatively rigid portions at both the front and rear portions of the tube 3350 can be advantageous because it increases the resistance to bending of both the front and rear portions of the tube 3350 during use. However, in some examples, depending on the rigidity, sufficient resistance to bending in both directions can be obtained with only a rigid portion on one side, so the rigid portion is provided on only one of the front or rear portions of the tube 3350. In other examples, the rigid portion can be provided along the entire length of the gas delivery tube 3350, while in further examples, the rigid portion is provided on only a part of the length of the gas delivery tube 3350. For example, the rigid portion can be provided on one of the lower or upper parts of the tube. For example, the upper part of each tube 3350 of the positioning and stabilization structure 3300 shown in FIGS. 3 and 4 can be more bendable in a specific direction than in the orthogonal direction. For example, making the upper part of the gas delivery tube more bendable can assist in fitting the positioning and stabilization structure to the shape of the patient's skull (especially around the curvature of the crown).

[0208] Each gas delivery tube 3350 of the positioning and stabilization structure 3300 can include an upper tube portion 3304. This upper tube portion 3304 extends, for example, around the line of the upper ear base point in the rearward direction from the upper part of the patient's head during use and is configured to be placed on the upper region of the patient's head during use of the patient's head. Conversely, the lower part 3306 of each tube 3350 of the positioning and stabilization structure 3300 shown in FIGS. 3 and 4 (this lower part extends rearward from the upper ear base point of the patient's head during use) can be more bendable in a specific direction than in the orthogonal direction.

[0209] In some examples of the present technology, the upper tube portion 3304 may also include one or more stiffening portions relative to the lower tube portion 3306. These stiffening portion(s) may be configured to provide higher resistance to relative movement in the forward and / or rearward directions rather than in the upward and / or downward directions. This can be advantageous, for example, when dealing with all the dragging generated from the air circuit. The stiffening portion may, in some examples, be provided throughout the length of the tube 3350 and, in some examples, may provide different rigidities along the length of the tube 3350.

[0210] In an example, the stiffening portion(s) of the gas delivery tube may be provided by the window portion. Since it is formed of an elastomeric material, the window portion may inherently have a higher rigidity than the textile material or the foamed material forming at least a substantial portion of the rest of the gas delivery tube.

[0211] In some examples, the relative rigidity of the gas delivery tube may be determined by the configuration of the window portion. In the embodiment of FIG. 5, for example, an increase in the rigidity of the gas delivery tube 3350 may be enabled by an increase in the thickness of one or both of the window portions 3355 and 3356. In another example, an increase in the rigidity of the gas delivery tube may be enabled by reducing the thickness of one of the window portions 3355 to be lower than that of the other window portion 3356. Depending on the desired rigidity, the thickness of the window portion(s) may be increased or decreased along the length of the gas delivery tube 3350. Thereby, different rigidities may be imparted to the lower portion 3306 and the upper portion 3304 of the gas delivery tube.

[0212] Increasing the relative width of one or both of the window portions 3355 and 3356 (i.e., reducing the existing textile material and increasing the silicone material present in the window portion (i.e., increasing the ratio of the surface area of the window portion relative to the textile material on the non-patient contact side of the gas delivery tube)) can similarly increase the rigidity of the gas delivery tube. The ratio of the window portion to the textile material can be in the range of 1:10 to 1:1. For example, in FIG. 5, the window portions 3355 and 3356 are about one-eighth of the width of the textile elongate piece forming the non-patient contact side 3354 (i.e., a ratio of 1:8). Doubling the width of the window portions 3355 and 3356 by a corresponding reduction in the width of the textile material forming the non-patient contact side 3354 can lead to an increase in the rigidity of the gas delivery tube. Since the width of the window portion can increase or decrease along the length of the gas delivery tube 3350, different rigidities are provided to the lower portion 3306 and the upper portion 3304 of the gas delivery tube.

[0213] Increasing the rigidity of the gas delivery tube 3350 by rigidity can also be achieved by adding a rigidifying screw to the textile material (e.g., by sewing). The rigidifying screw enables imparting rigidity to the textile material (substantially without increasing the weight of the textile material). For weight reduction and improved patient compliance, the rigidifying screw can be used instead of a wider window portion.

[0214] In embodiments where the window portions 3355 and 3356 are positioned along the rear and front sides of the gas delivery tube (e.g., those shown in FIGS. 5 and 6), one or the other of these window portions can be configured to be more rigid than the other. For example, the window portion on the front side of the gas delivery tube can be configured to be more rigid than the window portion on the rear side of the gas delivery tube. That is, the gas delivery tube 3350 has a higher resistance to forces applied from the rearward direction (e.g., those generated when the air circuit is dragged or caught on bedding). In another example, the window portion on the rear side of the gas delivery tube can be configured to be more rigid than the window portion on the front side of the gas delivery tube. That is, the gas delivery tube 3350 has a higher resistance to forces applied from the forward direction.

[0215] 5.3.3.1.6 Another Gas Delivery Tube Structure In another example of the present technology, FIG. 9 shows the lower portion 3306 of the gas delivery tube 3350 when decoupled from the plenum chamber 3200. In contrast to the above example, both the patient contact side 3351 and the non-patient contact side 3354 of the gas delivery tube 3360 are mainly constructed from a transparent material in the form of an elastomer. That is, the flow path (or a substantial portion thereof) within the gas delivery tube 3350 is entirely defined by the elastomer. In the example, since the elastomer is silicone, it is gas-impermeable and medically suitable for defining a hygienic flow path. Other examples of elastomers can be TPE or TPU.

[0216] The patient contact side 3351 is configured to permanently or temporarily receive the textile pad 3308, whereby a comfortable and softer surface contacts the patient's face during use. In other words, the textile pad 3308 does not form part of the passage through which pressurized air flows internally. In the example, the textile pad 3308 may be added during manufacture or, if desired, provided separately on the gas delivery tube for attachment by the patient to the gas delivery tube. This may enable the conduit headgear to be provided in a non-textile form, and the patient can place the textile pad on a specific area of the patient contact side of the gas delivery tube according to their preference. For example, the textile pad may be added to the upper portion of the gas delivery tube 3350 that contacts the crown of the patient's head.

[0217] Since it is not necessary to configure the textile pad 3308 together with the surface forming a part of the flow path of the gas delivery tube 3350, this function can be entirely achieved by a transparent material forming at least a substantial part of the flow path within the gas delivery tube, and the textile including the gas-impermeable layer may become unnecessary. The textile pad 3308 may include one or more fabrics (e.g., nylon, polyester, or spandex or blends thereof). In some examples, the textile pad 3308 may include a material that is sufficiently stretchable and elastic so that the flexibility of the conduit headgear 3300 (e.g., to accommodate the movement of the concertina portion 3358 of the conduit headgear in FIGS. 10-12) is not hindered.

[0218] In these examples, the textile pad 3308 is joined to the transparent material through the use of an adhesive or a similar bonding agent. In other examples, the textile pad 3308 can be fixed to the transparent material by, for example, hook and loop material (e.g., VELCRO®). In a further example, the transparent material can be overmolded onto the textile pad 3308.

[0219] In some examples, for the support of the placement of the textile pad 3308, the patient contact side 3351 of the gas delivery tube 3350 can be shaped to include a partial recess or depression or formed in other ways. Doing so can be advantageous in terms of improving the unity of the appearance and feel of the gas delivery tube 3350 and can lead to an improvement in attractiveness to consumers. In some examples, the recess can be provided with one of the hook and loop materials, and the other of the hook and loop materials is provided on the opposite side of the textile pad 3308. This makes it possible to remove the textile pad for cleaning to remove skin oils and dirt generated due to contact with the patient's face.

[0220] In FIG. 9, the textile pad 3308 extends as far upward as possible from the lower end of the gas delivery tube 3350, similar to the tab 3312 that extends rearward from the gas delivery tube. In some examples, the textile pad 3308 can be configured with the corresponding tab so as to cover the tab 3312 of the gas delivery tube. Thereby, the comfort when the tab 3312 of the gas delivery tube contacts the patient's face and / or hair (when the positioning and stabilization structure is worn) can be improved.

[0221] In FIG. 9, only the lower portion 3306 of the gas delivery tube is shown with the textile pad 3308 provided thereon. However, in other examples, the upper portion 3304 of the gas delivery tube 3350 may be additionally or alternatively configured with the textile pad 3308. This may be a textile pad different from the textile pad provided on the lower portion 3306 of the gas delivery tube, or alternatively, as shown in FIG. 10, a single textile pad may cover both the upper portion 3304 and the lower portion 3306 of the gas delivery tube 3350. Covering both the upper portion 3304 and the lower portion 3306 with the textile material may be particularly useful for patients with little hair on the scalp or sides of the head and patients who dislike the elastomeric material contacting the skin. There is also a low risk of the elastomeric material catching on the patient's hair if the positioning and stabilization structure unexpectedly moves on the patient's head.

[0222] In some examples, such as those shown in FIGS. 11 and 12, the patient contact side of the gas delivery tube 3350 includes a textile pad 3308, which can also be added to the non-patient contact side of the gas delivery tube 3350, and windows 3355 and 3356 are exposed. In this example, at least a substantial portion of the flow path within the gas delivery tube is formed by a transparent material. By using a textile pad 3350 joined through the use of an adhesive, a molding technique, or a hook and loop material (e.g., VELCRO®), the finish of the non-patient contact side of the gas delivery tube can be made aesthetically pleasing and tactilely comfortable when the patient needs to touch it (e.g., during attachment and detachment of the positioning and stabilization structure).

[0223] 5.3.4 Ventilation part In one form, the patient interface 3000 includes a ventilation part 3400 configured and arranged to allow the expulsion of exhaled gas (e.g., carbon dioxide).

[0224] In a particular form, the ventilation part 3400 is configured to allow a continuous ventilation flow from the inside of the plenum chamber 3200 to the surroundings when the pressure in the plenum chamber is positive relative to the surroundings. The ventilation part 3400 is configured such that, while maintaining the therapeutic pressure in the plenum chamber during use, the magnitude of the ventilation flow rate is sufficient to reduce rebreathing by the patient of the exhaled CO 2 to a sufficient size.

[0225] One form of the ventilation part 3400 according to the present technology includes a plurality of holes (e.g., about 20 to about 80 holes or about 40 to about 60 holes or about 45 to about 55 holes).

[0226] The ventilation part 3400 can be disposed within the plenum chamber 3200. Alternatively, the ventilation part 3400 is disposed within a disconnect structure (e.g., an elbow joint).

[0227] 5.3.5 Disconnect structure(s) In one form, the patient interface 3000 includes at least one release structure (e.g., a swivel or ball and socket).

[0228] 5.3.6 Connection Port The connection port 3600 enables connection to the air circuit 4170.

[0229] 5.3.7 Anti - asphyxiation Valve In one form, the patient interface 3000 includes an anti - asphyxiation valve.

[0230] 5.3.8 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that enable access to the volume within the plenum chamber 3200. In one form, this enables a clinician to supply supplemental oxygen. In one form, this enables direct measurement of the characteristics (e.g., pressure) of the gas within the plenum chamber 3200.

[0231] 5.4 RPT Device The RPT device 4000 according to one aspect of the present technology includes mechanical components, pneumatic components, and / or electrical components and is configured to execute one or more algorithms 4300. The RPT device 4000 can be configured to generate an air flow that is delivered to a patient's airway, for example, for the treatment of one or more of the respiratory diseases described anywhere in this document.

[0232] In one form, the RPT device 4000 is constructed and arranged to deliver an air flow in the range of - 20 L / min to + 150 L / min while maintaining a positive pressure of at least 6 cmH 2 O or at least 10 cmH 2 O or at least 20 cmH 2 O.

[0233] 5 Glossary For the purposes of the disclosure of the present technology, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, other definitions may also apply.

[0234] 5.1 General Air: In certain forms of the present technology, air may mean the atmosphere, and in other forms of the present technology, air may mean a combination of other breathable gases (e.g., an atmosphere rich in oxygen).

[0235] Ambient: In certain forms of the present technology, the term "ambient" should be taken to mean (i) outside the treatment system or the patient, and (ii) that which directly surrounds the treatment system or the patient.

[0236] For example, the ambient humidity for a humidifier may be the humidity of the air that directly surrounds the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may be different from the humidity outside the room where the patient is sleeping.

[0237] In another example, the ambient pressure may be the pressure directly surrounding or outside the body.

[0238] In certain forms, ambient (e.g., acoustic) noise can be considered the background noise level in the room where the patient is located, for example, other than the noise generated from the RPT device or from the mask or patient interface. Ambient noise can be generated from sources outside the room.

[0239] Automatic Positive Airway Pressure (APAP) Therapy: A form of CPAP therapy that can automatically adjust the treatment pressure between a minimum and a maximum, for example, in response to the presence or absence of signs of SDB onset during respiration.

[0240] Continuous Positive Airway Pressure (CPAP) therapy: A respiratory pressure therapy in which the treatment pressure is substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet rises slightly during exhalation and drops slightly during inhalation. In some forms, the pressure varies between different respiratory cycles of the patient (e.g., increased in response to detection of signs of partial upper airway obstruction and reduced in the absence of notification of partial upper airway obstruction).

[0241] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous amount. In some cases, when referring to flow rate, it refers to a scalar quantity (i.e., a quantity having only magnitude). In other cases, when referring to flow rate, it refers to a vector quantity (i.e., a quantity having both magnitude and direction). Flow rate may be given the symbol Q. The "flow rate" may also be abbreviated as "flow" for simplicity.

[0242] In an example of patient breathing, the flow rate can be nominally positive during the inhalation portion of the patient's respiratory cycle and negative during the exhalation portion of the patient's respiratory cycle. The total flow rate Qt is the flow rate of air exiting the RPT device. The vent flow rate, Qv, is the flow rate of air exiting the vent for exhalation washout. The leak flow rate Ql is the flow rate of leakage from the patient interface system or another location. The respiratory flow rate Qr is the flow rate of air received within the patient's respiratory system.

[0243] Humidifier: The term "humidifier" is interpreted to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H 2 O) vapor to an air flow for improving the patient's medical respiratory condition.

[0244] Leakage: The term "leakage" is taken as an unintended air flow. In one example, leakage can occur due to an incomplete seal between the mask and the patient's face. In another example, leakage can occur at the ambient elbow.

[0245] Patient: A person with or without a respiratory disease.

[0246] Pressure: Force per unit area. Pressure can be expressed in various units (e.g., cmH 2 O, g-f / cm 2 , and hectopascal). 1 cmH 2 O is equal to 1 g-f / cm 2 and is approximately 0.98 hectopascal. In this specification, unless otherwise specified, pressure is given in the unit of cmH 2 O.

[0247] The pressure in the patient interface is denoted by the symbol Pm, and the therapeutic pressure representing the target value to be achieved by the mask pressure Pm at the current time is denoted by the symbol Pt.

[0248] Respiratory pressure therapy (RPT): The addition of an air supply to the airway inlet at a therapeutic pressure that is typically positive pressure with respect to the atmosphere.

[0249] Ventilator: A mechanical device that provides pressure assistance when a patient performs part or all of the breathing motion.

[0250] 5.1.1 Materials Silicone or silicone elastomer: A synthetic rubber. In this specification, when silicone is mentioned, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). As one form of commercially available LSR, there is SILASTIC manufactured by Dow Corning (included in the product group sold under this trademark). Another LSR manufacturer is Wacker. Unless otherwise specified, the Shore A (or Type A) indentation hardness of the exemplary form of LSR as measured by ASTM D2240 is in the range of about 35 to about 45.

[0251] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0252] 5.1.1.1 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0253] Elastic: Releases substantially all energy during unloading. Includes, for example, certain silicones and thermoplastic elastomers.

[0254] Hardness: The ability of a material to resist deformation of itself (e.g., as described by Young's modulus or an indentation hardness scale measured on a standardized sample size). ● "Soft" materials may include silicones or thermoplastic elastomers (TPE) and can be easily deformed, for example, under finger pressure. ● "Hard" materials may include polycarbonate, polypropylene, steel, or aluminum and cannot be easily deformed, for example, under finger pressure.

[0255] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, extension, bending, or torsion). A structure or component may provide different resistance in different directions.

[0256] Floppy structure or component: A structure or component that changes shape (e.g., bends) within a relatively short period (e.g., 1 second) when supported under its own weight.

[0257] Rigid structure or component: A structure or component that undergoes substantially no shape change when subjected to loads typically encountered during use. An example of such an application may be to set up and maintain a patient interface in a sealed manner against the patient's airway inlet at a pressure load of, for example, approximately 20 - 30 cmH 2 O.

[0258] As an example, an I-beam may include different bending rigidities (resistance to bending loads) in a first direction as compared to a second orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.

[0259] 5.1.2 Respiratory cycle Apnea: According to some definitions, apnea is said to occur when a flow below a predetermined threshold persists for a continuous period, for example, for 10 seconds. Obstructive apnea is said to occur when airflow is not permitted due to some airway obstruction despite the patient's efforts. Central apnea refers to a state in which apnea is detected due to a decrease or absence of respiratory effort even though the airway is open. Mixed apnea refers to a state in which a decrease or absence of respiratory effort occurs simultaneously with airway obstruction.

[0260] Respiratory rate: The patient's spontaneous respiratory rate, usually measured as the number of breaths per minute.

[0261] Expiratory portion of the respiratory cycle: The period from the start of the expiratory flow to the start of the inspiratory flow.

[0262] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0263] Patency (airway): The degree to which the airway is open or the extent to which the airway is open. The open airway is, well, open. Quantification of airway patency can be performed, for example, using a value (1) indicating patency and a value (0) indicating closure (obstruction).

[0264] Ventilation: Measurement of the gas exchange rate performed by the patient's respiratory system. Measurement of ventilation may include one or both of the inspiratory and expiratory flows per unit time. When expressed as a volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation may simply be given as a volume and is understood as a volume per minute.

[0265] 5.1.3 Anatomical Structure 5.1.3.1 Anatomical Structure of the Face Auricle: The entire visible part of the ear.

[0266] (Nasal) Skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0267] (Nasal) Cartilage Skeleton: The nasal cartilage skeleton includes the septal cartilage, lateral cartilage, major cartilage, and minor cartilage.

[0268] Frankfort Horizontal Plane: A line extending from the lowest point of the orbital margin to the auricular point of the left ear. The auricular point is the deepest point from the upper notch to the tragus of the auricle.

[0269] Glabella: A point located in the soft tissue and most prominent in the mid-sagittal plane of the frontal region.

[0270] Lower Lip (labrale inferius): A point on the face between the mouth and the supramenton, placed within the mid-sagittal plane.

[0271] Upper Lip (labrale superius): A point on the face between the mouth and the nose, placed within the mid-sagittal plane.

[0272] Nostrils (Nasal Cavities): Generally elliptical wing-shaped cavities that form the entrance to the nasal cavity. The singular form of the nostrils is nostril (nasal cavity). These nostrils are separated by the nasal septum.

[0273] Lower Auricular Attachment Point: The lowest point of attachment of the auricle to the facial skin.

[0274] Upper Auricular Attachment Point: The highest point of attachment of the auricle to the facial skin.

[0275] 5.1.3.2 Anatomical Structure of the Skull Frontal Bone: The frontal bone includes the frontal squama, which is a large vertical part corresponding to the region known as the forehead.

[0276] Mandible: The mandible forms the lower jaw part. The mental eminence is a bony prominence of the jaw and forms the jaw.

[0277] Maxilla: The maxilla forms the upper jaw part and is located below the lower part of the mandible and below the eye socket. The frontal process of the maxilla projects upward by the side of the nose and forms the part of its outer boundary.

[0278] Nasal bone: The nasal bone consists of two small rectangular bones, and its size and shape vary from person to person. The nasal bones are arranged side by side in the middle and upper parts of the face, and their junction forms the "bridge" of the nose.

[0279] Nasion: It is the intersection of the frontal bone and the two nasal bones, and is a concave area directly provided between the upper part of the eye and the bridge of the nose.

[0280] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes the foramen magnum which is an elliptical hole, and through this hole, the cranial cavity communicates with the spinal canal. The curved panel behind the foramen magnum is the occipital squama.

[0281] Eye socket: It is a bony cavity in the skull and contains the eyeball.

[0282] Parietal bone: The parietal bones are bones that form the top and sides of the skull when joined together.

[0283] Temporal bone: The temporal bone is located on the base and sides of the skull and supports the part of the face known as the temple.

[0284] Zygomatic bone: The two zygomatic bones contained in the face are located in the upper and outer parts of the face and form the cheek prominences.

[0285] 5.1.3.3 Anatomical Structure of the Respiratory System Diaphragm: It is a sheet-like muscle that extends over the lower part of the chest cavity. The diaphragm separates the thoracic cavity containing the heart, lungs and ribs from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0286] Larynx: The larynx, or voice box, that houses the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0287] Lungs: The respiratory organs in humans. The conductive zone of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0288] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the center of the face. The nasal cavity is divided into two by a vertical fin called the nasal septum. There are three horizontal extensions on the sides of the nasal cavity called turbinates (singular "concha") or nasal conchae. In front of the nasal cavity is the nose, and behind it connects to the nasopharynx through the posterior nares.

[0289] Pharynx: The part of the throat located directly below (inferior) the nasal cavity and above the esophagus and larynx. The pharynx has traditionally been divided into the following three parts: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (mesopharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0290] 5.1.4 Patient interface Anti-asphyxia valve (AAV): A component or sub-assembly of the mask system that reduces the risk of rebreathing excessive CO 2 by the patient through an opening to the atmosphere in a fail-safe manner.

[0291] Elbow: An elbow is an example of a structure that directs the axis of the airflow moving inside and changes the direction through 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. The elbow can have a substantially circular cross-section. In another form, the elbow can have an elliptical or rectangular cross-section. In a particular form, the elbow can be rotatable, for example, about 360 degrees relative to the mating component. In a particular form, the elbow can be removable from the mating component, for example, via a snap connection. In a particular form, the elbow can be assembled to the mating component via a one-time snap during manufacture, while being non-removable by the patient.

[0292] Frame: The frame is taken to mean a mask structure that supports the tensile load between two or more points connecting the headgear. The mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of the mask frame can be airtight.

[0293] Headgear: The headgear is taken to mean a form of positioning and stabilization structure designed to be used on the head. For example, the headgear can include a collection of one or more struts, ties, and supplementary stiffeners configured to position and hold a patient interface at a predetermined position on the patient's face for the delivery of respiratory therapy. Some ties are formed of a soft, flexible elastic material (e.g., a laminated composite of foam and fabric).

[0294] Membrane: The membrane is taken to typically mean a thin element, preferably substantially resistant to bending and resistant to stretching and contraction.

[0295] Pleural Chamber: The mask pleural chamber is taken to mean a part of the patient interface having a wall that at least partially encloses the volume of the space, and the air in the volume is pressurized to exceed atmospheric pressure during use. The shell can form part of the wall of the mask pleural chamber.

[0296] Seal: When used as a noun (the "seal"), it can refer to the structure, and when used as a verb (to "seal"), it can refer to the effect. The two elements can be constructed and / or arranged such that they "seal" between them or achieve a "sealing" effect without requiring separate "seal" elements themselves.

[0297] Shell: The shell is taken to mean a relatively thin-walled, curved structure having bending, tensile, and compressive rigidity. For example, the curved structural wall of a mask can be a shell. In some forms, the shell can be faceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0298] Reinforcing member: A reinforcing member is taken to mean a structural component designed to increase the stiffness or softness of another component in at least one direction.

[0299] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0300] Swing (noun): A sub-assembly of components configured to rotate preferably independently and preferably under low torque about a common axis. In one form, the swing can be configured to rotate at an angle of at least 360 degrees. In another form, the swing can be configured to rotate at an angle less than 360 degrees. When used in the context of an air delivery conduit, the sub-assembly of components preferably includes a pair of cylindrical conduits in combination. In use, there is little leakage of the air flow from the swing.

[0301] Tie (noun): A structure designed to resist tension.

[0302] Ventilation: (noun): A structure that allows an air flow to the ambient air inside a mask or conduit, enabling a clinically effective flushing of the exhaled gas. For example, in a clinically effective flushing, a flow rate of about 10 liters / min to about 100 liters / min can be used depending on the mask design and the treatment pressure.

[0303] 5.1.5 Shape of the structure The product according to the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or an impeller). The three-dimensional structure may be bounded by two-dimensional surfaces. These surfaces may be distinguished using labels for describing the direction, position, function, or some other property of the associated surface. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a face contact (e.g., outer) surface and a separate non-face contact (e.g., lower or inner) surface. In another example, the structure may include a first surface and a second surface.

[0304] To simplify the description of the shape of the three-dimensional structure and the surface, consider a cross-section through the surface of the structure at point p. The outward normal vector at p points in the direction away from the surface. In some examples, this surface is described from the perspective of a fictional small person standing upright on the surface.

[0305] 5.1.5.1 Curvature in one dimension The curvature of a planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., 1 / radius of the circle tangent to the curve at p).

[0306] Positive curvature: When the curve at p bends towards the outward normal, the curvature at that point is taken to have a positive value (when this fictional small person walks away from point p, they need to walk uphill). Such a curve is often called concave.

[0307] Zero curvature: When the curve at p is a straight line, the curvature is taken as zero (if this imaginary little person leaves point p, they can walk on a horizontal plane that is neither upward nor downward).

[0308] Negative curvature: When the curve at p bends in a direction away from the outward normal, the curvature at that point and in that direction is taken as having a negative value (if this imaginary little person leaves point p, they need to walk downhill). Such a curve is often called convex.

[0309] 5.1.5.2 Curvature of a two-dimensional surface The description of the shape at a given point on a two-dimensional surface according to this technology may include a plurality of vertical cross-sections. The plurality of cross-sections may cut the surface in a plane containing the outward normal ("normal plane"), and each cross-section may be taken in a different direction. As a result of each cross-section, a planar curve with a corresponding curvature is obtained. The different curvatures at that point may have the same sign or different signs. The curvatures at that point each have a magnitude (for example, relatively small).

[0310] Principal curvatures and directions: The directions of the normal planes in which the curvature of the curve takes its maximum and minimum values are called the principal directions.

[0311] Region of the surface: A set of connected points on the surface. This set of points within the region may have similar characteristics (for example, curvature or sign).

[0312] Saddle region: A region where the principal curvatures at each point have opposite signs (i.e., one has a positive sign and the other has a negative sign) depending on the direction in which an imaginary person who can walk uphill or downhill faces.

[0313] Dome region: A region where the principal curvatures at each point have the same sign (both positive ("concave dome") or both negative ("convex dome")).

[0314] Cylindrical region: A region where one principal curvature is zero (or zero within manufacturing tolerances, for example), and the other principal curvature is non-zero.

[0315] Flat region: A region of a surface where both principal curvatures are zero (or zero within manufacturing tolerances, for example).

[0316] Edge of a surface: The boundary or limit of a surface or region.

[0317] Path: In certain embodiments of the present technology, a "path" is taken to mean a path in the mathematical - topological sense (e.g., a continuous space curve on a surface from f(0) to f(1)). In certain embodiments of the present technology, a "path" can be described as a route or course that includes, for example, a set of points on a surface. (The path of a fictional person is where one walks on a surface and is similar to a path in a garden).

[0318] Path length: In certain embodiments of the present technology, "path length" is taken to refer to the distance from f(0) to f(1) along a surface (i.e., the distance along a path on a surface). There can be more than one path between two points on a surface, and such paths can have different path lengths. (The path length of a fictional person is the distance walked along a path on a surface).

[0319] Straight - line distance: The straight - line distance is the distance between two points on a surface without considering the surface. On a flat region, there is a distance along the surface edge that has the same path length as the straight - line distance between two points on the surface. On a non - flat surface, there may not be a path that has the same path length as the straight - line distance between two points. (For a fictional person, the straight - line distance corresponds to the "distance a crow flies").

[0320] 5.1.5.3 Hole A surface can have one - dimensional holes (e.g., holes bounded by a planar curve or a space curve). In the case of a thin - walled structure (e.g., a membrane) that contains holes, this structure can be described as having one - dimensional holes.

[0321] The structure may have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the inner surface of the tire. In another example, a bladder with a cavity for air or gel may have a two-dimensional hole. In yet another example, a conduit may include a one-dimensional hole (e.g., at its inlet or its outlet) and may include a two-dimensional hole bounded by the inner surface of the conduit.

[0322] 5.2 Other Considerations Part of the disclosure of this patent document includes content that is given copyright protection. The copyright owner has no objection if anyone reproduces this patent document or this patent disclosure by fax, provided it is for the purpose of what is described in the patent file or record of the Patent Office, but retains all copyrights for other purposes.

[0323] Unless otherwise clear from the context and unless a range of values is provided, it is understood that each intervening value between the lower limit of one-tenth of the unit of the lower limit, between the upper and lower limits of the range, and any other stated value or intervening value in the stated range is encompassed by the technology. Even if the upper and lower limits of these intervening ranges independently included within the intervening range particularly exceed the limitations in the stated range, they are encompassed by the technology. If the stated range includes one or both of these limitations, ranges exceeding either or both of these stated limitations are also encompassed by the technology.

[0324] Furthermore, when a value (singular or plural) is embodied as part of the technology in this specification, unless otherwise specified, it is understood that such a value may be approximated and such a value can be used to any appropriate significant digit up to the range permitted or required by the actual technical implementation.

[0325] Furthermore, "about", "substantially", "approximately" or any similar term used in this specification means + / -5 to + / -10% of the stated value.

[0326] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present technology, only a limited number of exemplary methods and materials are described herein.

[0327] Although specific materials are described as being preferably used in the construction of components, obvious alternative materials with similar properties can be used as substitutes. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and can be manufactured either collectively or individually.

[0328] As used herein and in the appended claims, note that the singular forms "a", "an", and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0329] All of the published documents described herein are incorporated by reference for the disclosure and description of the methods and / or materials that are the subject of these published documents. The published documents described herein are provided only for their disclosure prior to the filing date of the present application. Nothing in this specification should be construed as an admission that the present technology does not antedate such published documents by virtue of prior invention. Further, the dates of the published documents described may be different from the actual publication dates and may need to be individually verified.

[0330] The terms "comprises" and "comprising" are to be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that the recited elements, components, or steps can be present, utilized, or combined with other elements, components, or steps not expressly recited.

[0331] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found throughout the present disclosure or the claims. These headings should not be used in the interpretation of the claims or the scope of the limitations of the claims.

[0332] Although the techniques in this specification have been described with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details that are unnecessary for the implementation of the technology. For example, terms such as "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any order and are used to distinguish separate elements. Further, when describing or exemplifying the process steps in this method, they may be presented in an ordered manner, but such an order is not necessary. One skilled in the art will recognize that such an order can be changed and / or that the aspects can be performed simultaneously or even synchronously.

[0333] Therefore, it should be understood that numerous variations are possible in the exemplary examples without departing from the spirit and scope of the technology, and other arrangements can be devised.

Description of Reference Numerals

[0334] 1000 Patients 1100 Roommate 3000 Patient Interface 3100 Sealing or Seal - Forming Structure 3150 Cushion Module 3200 Plenum Chamber 3300 Positioning and Stabilization Structure / Headgear 3304 Upper Tube Portion 3306 Lower Tube Portion 3308 Textile Pad 3310 Strap 3312 Tabs (for straps) 3350 Headgear tube 3351 (Patient contact side of the headgear tube) 3352 Inner non-gas permeable layer 3353 Outer textile layer 3354 (Non-patient contact side of the headgear tube) 3355 Window part (front side part) 3356 Window part (rear side part) 3357 Semi-circular outer shape (of the window part) 3358 Concertina part (of the headgear tube) 3359A Ridge (of the concertina part) 3359B Groove part (of the concertina part) 3360 Crown connector 3390 Fluid connection opening 3400 Ventilation part 3600 Connection port 3610 Elbow 4000 RPT device 4170 Air circuit LA Longitudinal axis TA Transverse axis θ Angle

Claims

1. 1. A patient interface for delivering a pressurized flow of air to a patient for treatment of sleep disordered breathing, comprising: At least 6 cmH above ambient air pressure ２ a cushion module at least partially defining an interior space pressurizable to an elevated therapeutic pressure; at least one gas delivery tube connected to the cushion module; It is equipped with The cushion module includes: at least one inlet port sized and configured to receive air flow at said treatment pressure; a seal-forming structure configured to, in use, form a seal with a facial area of ​​a patient for delivering airflow to an airway of the patient for treating sleep disordered breathing; Equipped with at least one of the gas delivery conduits is configured to extend, in use, from at least a region of the patient's head above an upper ear-base point of the patient's head along at least one side of the patient's head to a location adjacent the cushion module; the gas delivery tube having a tube wall defining an interior passage for moving the air stream; The pipe wall is a patient-contacting portion including an inner textile material configured to contact the patient's head in use, the inner textile material having a first elongated edge and a second elongated edge extending along a length of the inner textile material; a non-patient-contacting portion comprising an outer textile material configured to be positioned away from the patient's skin in use, the outer textile material having a first elongate edge and a second elongate edge extending along a length of the outer textile material; a first side comprising silicone and disposed between the patient contacting portion and the non-patient contacting portion; Equipped with the silicone of the first side is overmolded onto the first elongated edge of the inner textile material and onto the first elongated edge of the outer textile material, whereby the silicone connects and extends between the patient-contacting portion and the non-patient-contacting portion; A patient interface, wherein the silicone is transparent and / or translucent to form a first window for permitting viewing of the internal passageway through the silicone.

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

3. The patient interface of claim 1 , wherein the gas delivery tube has a D-shaped cross-section.

4. The patient interface of claim 1 , wherein, in use, the first side is disposed along a front or rear side of the gas delivery tube.

5. 10. The patient interface of claim 1, wherein the tube wall further comprises a second side comprising silicone and disposed between the patient contacting portion and the non-patient contacting portion.

6. 6. A patient interface as described in claim 5, wherein the silicone of the second side is transparent and / or translucent to form a second window to allow viewing of the internal passageway through the silicone of the second side.

7. 6. A patient interface as described in claim 5, wherein the silicone of the second side is overmolded onto the second elongated edge of the inner textile material and onto the second elongated edge of the outer textile material, whereby the silicone of the second side connects and extends between the patient-contacting portion and the non-patient-contacting portion.

8. 8. A patient interface as described in claim 7, wherein, in use, the first side is disposed along a front side of the gas delivery tube and the second side is disposed along a rear side of the gas delivery tube.

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

10. 8. The patient interface of claim 7, wherein the wall of the gas delivery tube has a unitary sided construction including the patient contacting portion, the non-patient contacting portion, the first side, and the second side.

11. 10. The patient interface of claim 1, wherein the at least one gases delivery conduit comprises a single gases delivery conduit having left and right arms configured to extend along respective sides of the patient's face in use.

12. 12. A patient interface according to claim 11, wherein the left and right arms each include a tab configured to receive a respective end of a rear strap.

13. 12. The patient interface of claim 11, wherein the inlet port comprises two inlet ports each located on opposite sides of the cushion module.

14. 14. A patient interface according to claim 13, wherein each of the inlet ports is connected to one of the left and right arms of the gas delivery tube, respectively.

15. 2. A patient interface as described in claim 1, wherein the silicone of the first side has an inner surface forming a portion of a surface of the internal passage, the inner surface having a concave depression formed therein and extending along a length of the gas delivery tube.

16. 16. The patient interface of claim 15, wherein the concave recess is formed in an overlap area of ​​the gas delivery tube where the silicone on the first side overlaps the first elongated edge of the inner textile material.

17. 10. The patient interface of claim 1, wherein the inner and outer textile materials each have a gas impermeable layer applied thereto.

18. 10. The patient interface of claim 1, wherein the first side portion comprises a concertina portion configured to extend along a length of the gas delivery tube.

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

20. 10. The patient interface of claim 1, wherein the cushion module is a cradle cushion module.

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