Positioning and stabilising structure with textile sleeve

Abstract

To provide a medical device used in screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders, the medical device having one or more of improved comfort, cost, effectiveness, ease of use, and manufacturability.SOLUTION: A positioning and stabilising structure of the present disclosure includes a gas delivery tube to deliver a flow of air to an entrance of a patient's airways via a seal-forming structure, and an elongate textile sleeve provided around the gas delivery tube and arranged to be in contact, in use, with the patient's face. The sleeve includes a wall with an opening, which allows the patient to view a portion of the gas delivery tube. A strap engaging portion is configured to protrude through the opening of the textile sleeve in use. A clearance exists in a longitudinal direction between an edge of the opening and the strap engaging portion. The clearance allows the gas delivery tube to stretch, in use, without the strap engaging portion contacting the edge of the opening.SELECTED DRAWING: Figure 11

Description

[Technical Field]

[0001] The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatus, and uses thereof. [Background technology]

[0002] 1.2.1 Human respiratory system and its disorders The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways.

[0003] These airways contain a series of branches that become narrower, shorter, and more numerous the deeper they travel into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into venous blood and carbon dioxide to move in the opposite direction. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and ultimately into alveoli. Gas exchange occurs in the alveolar region of the lung, known as the respiratory zone. See Respiratory Physiology, 9th Edition, by John B. West, Lippincott Williams & Wilkins, 2012.

[0004] There are a variety of respiratory disorders, and particular disorders can be characterized by particular episodes (e.g., apnea, hypopnea, and hyperpnea).

[0005] Respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall disorders.

[0006] Obstructive sleep apnea (OSA), a form of sleep-disordered breathing (SDB), is characterized by events involving the obstruction or closure of the upper airway during sleep. This is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the area of ​​the tongue, soft palate, and posterior oropharyngeal wall during sleep. Due to this condition, affected patients typically stop breathing for periods lasting 30 to 120 seconds, sometimes 200 to 300 times per night. This often results in excessive daytime sleepiness, which can contribute to cardiovascular disease and brain damage. This syndrome is common, particularly among middle-aged, overweight men, but patients often experience no symptoms. See U.S. Pat. No. 4,944,310 (Sullivan).

[0007] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory control system that results in alternating periods of waxing and waning ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with recurrent sleep arousals, which can cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0008] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following disorders:

[0009] Patients with respiratory insufficiency (a type of respiratory failure) may experience abnormal shortness of breath during exercise.

[0010] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0011] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics. These include increased resistance to air movement, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD can be caused by long-term smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0012] Neuromuscular disease (NMD) is a broad term encompassing numerous diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle impairment, resulting in inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disease characterized by muscle impairment that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and teenage Duchenne muscular dystrophy (DMD)). (ii) degenerative or slowly progressive disease characterized by muscle impairment that worsens over years but only mildly shortens life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, difficulty swallowing, difficulty breathing on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0013] Chest wall disorders are a group of thoracic deformities that result in ineffective connections between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive obstruction and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0014] A range of treatments are available to treat or ameliorate such diseases, and otherwise healthy individuals can also benefit from such treatments to prevent respiratory failure. However, these treatments suffer from several deficiencies.

[0015] 1.2.2 Treatment A variety of respiratory therapies (e.g., Continuous Positive Airway Pressure (CPAP) therapy, Non-invasive ventilation (NIV), Invasive ventilation (IV), and High Flow Therapy (HFT)) are used to treat one or more of the above-mentioned respiratory disorders.

[0016] 1.2.2.1 Respiratory Pressure Therapy Respiratory pressure therapy is the application of air to the entrance of the airways at a target pressure controlled to be nominally positive relative to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy, e.g., a tank ventilator or positive-negative pressure extracorporeal ventilator (cuirass)).

[0017] Continuous positive airway pressure (CPAP) has been used to treat obstructive sleep apnea (OSA). Its mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and may prevent closure of the upper airway by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall. Because treatment of OSA with CPAP therapy can be voluntary, patients may choose not to adhere to treatment if they find the devices used to deliver such treatment to be one or more of the following: uncomfortable, difficult to use, expensive, or aesthetically unappealing.

[0018] Noninvasive ventilation (NIV) provides ventilatory support to a patient via the upper airways to assist the patient in breathing and / or maintain adequate oxygen levels in the body by completing some or all of the work of breathing. Ventilatory support is provided via a noninvasive patient interface. NIV is used to treat CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0019] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments may be improved.

[0020] 1.2.2.2 Flow treatment Not all respiratory therapies are intended to deliver a prescribed therapeutic pressure. Some respiratory therapies aim to deliver a predetermined respiratory volume by delivering an inspiratory flow profile that overlaps a positive baseline pressure as closely as possible for a targeted duration. In other cases, the interface to the patient's airway is "open" (not sealed), and respiratory therapy with a flow of conditioned or concentrated gas may be used solely to support the patient's spontaneous breathing. In one example, high-flow therapy (HFT) involves providing a continuous, heated, humidified airflow to the airway through an unsealed or open patient interface at a "therapeutic flow" that remains nearly constant throughout the respiratory cycle. The therapeutic flow is nominally set to exceed the patient's peak inspiratory flow. HFT is used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that a high flow of air at the airway entrance improves ventilation efficiency by flushing or washing out exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes called deadspace therapy (DST). Other benefits may include improved warmth and humidification (possibly due to the benefit of secretion control) and a gradual increase in airway pressure. Instead of a constant flow rate, the therapeutic flow rate may follow a varying profile over the respiratory cycle.

[0021] 1.2.2.3 Supplemental oxygen Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. A physician may prescribe a continuous flow of oxygen-enriched gas to be delivered to a patient's airways at a specified oxygen concentration (between 21% and 100% of the oxygen fraction in ambient air) at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, or 3 LPM).

[0022] 1.2.3 Respiratory Treatment Systems These respiratory therapies may be provided by respiratory treatment systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor disease without treating it.

[0023] The respiratory therapy system may include a Respiratory Pressure Therapy Device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0024] Another form of treatment system is the mandibular repositioning device.

[0025] 1.2.3.1 Patient Interface A patient interface can be used to provide a wearer with an interface to a respiratory prosthesis, for example, by providing airflow to an entrance to the airway. Airflow can 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 treatment being applied, the patient interface can facilitate gas delivery at a pressure sufficiently different from ambient pressure, e.g., a positive pressure of at least 6 cmH2O, e.g., approximately 10 cmH2O, above ambient pressure, by forming a seal with a portion of the patient's face to effectively implement the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not provide a seal sufficient to facilitate delivery of a gas supply to the airway at a positive pressure of approximately 10 cmH2O. For flow treatments, such as nasal HFT, the patient interface insufflates the nares but is particularly positioned to not provide a complete seal. One example of such a patient interface is a nasal cannula.

[0026] Certain other mask systems may be functionally inadequate in this field. For example, masks intended for purely decorative purposes may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures, but not to maintain internal air at pressures higher than ambient.

[0027] For example, a particular mask may not be clinically suitable for this technology if it blocks airflow through the nose and only allows airflow through the mouth.

[0028] In certain masks, the patient must insert part of the mask structure into their mouth to create and maintain a seal with their lips, which can be uncomfortable or impractical in this technology.

[0029] Certain masks may be impractical for use while sleeping (e.g., when sleeping on your side in bed with your head resting on a pillow).

[0030] Designing a patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head contains bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. That is, the jaw or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory treatment period.

[0031] As a result of these challenges, some masks suffer from one or more of the following: intrusiveness, aesthetic undesirability, high cost, poor fit, difficulty to use, and discomfort, especially if worn for extended periods or if the patient is unfamiliar with the system. Using the wrong size mask can lead to reduced compliance, reduced comfort, and poor patient outcomes. While masks specifically designed for aviators, personal protective equipment (e.g., filter masks), masks designed as part of SCUBA masks, or masks for anesthesia administration may be durable for their intended use, such masks may be undesirably uncomfortable to wear for extended periods (e.g., several hours). Such discomfort can reduce patient compliance with treatment. This is especially true if the mask is required to be worn while sleeping.

[0032] CPAP therapy is highly effective in treating certain breathing disorders when patients comply with the therapy. If the mask is uncomfortable or difficult to use, patients may not comply with the therapy. Because patients are often encouraged to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean the mask, which may affect patient compliance.

[0033] Masks for other uses (e.g., aviators) may be unsuitable for use in treating sleep-disordered breathing, and masks designed for use in treating sleep-disordered breathing may be suitable for other uses.

[0034] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0035] 1.2.3.1.1 Seal formation structure The patient interface may include a seal-forming structure. Because the seal-forming structure is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

[0036] Patient interfaces may be characterized in part according to the design intent of the seal-forming structure when it is intended to engage the face in use. In one form of patient interface, the seal-forming structure may include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils in use. Such a single element may be designed to rest, for example, on the upper lip region and nose bridge region of the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth region in use, for example, by forming a seal on the lower lip region of the face. In one form of patient interface, the seal-forming structure may include a single element that surrounds both the nostril and mouth regions in use. These different types of patient interfaces may be known by various names depending on their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0037] A seal-forming structure that may be effective in one area of ​​a patient's face may be inappropriate in another area, for example, due to different shapes, structures, variability, and sensitive areas of the patient's face. For example, the seal of swimming goggles that rests on the patient's forehead may be inappropriate for use over the patient's nose.

[0038] A particular seal-forming structure can be designed for mass production so that one design is compatible, comfortable, and effective for a wide range of different face shapes and sizes. To the extent that there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-produced patient interface, one or both must be adapted to form a seal.

[0039] Some types of seal-forming structure extend around the periphery of the patient interface and are intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure engaging against the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or may include a molded or shaped surface of a resilient sealing element constructed of an elastomer such as rubber. With this type of seal-forming structure, an improper fit can result in gaps between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0040] Another type of seal-forming structure uses a thin flap seal positioned around the periphery of the mask to provide a self-sealing seal against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming portion, poor conformance between the face and the mask can require additional force to achieve a seal or cause the mask to leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming structure may wrinkle or buckle during use, causing leakage.

[0041] Other types of seal-forming structures may include friction-fit elements that are inserted into the nostrils, for example, but some patients find these uncomfortable.

[0042] Another form of seal-forming structure may use adhesives to achieve the seal, as some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0043] A range of patient interface seal forming construction techniques are disclosed in patent applications WO1998 / 004,310, WO2006 / 074,513 and WO2010 / 135,785 assigned to ResMed Limited.

[0044] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Pat. No. 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0045] ResMed Limited manufactures the following products that use nasal pillows: SWIFT® Nasal Pillows Mask, SWIFT® II Nasal Pillows Mask, SWIFT® LT Nasal Pillows Mask, SWIFT® FX Nasal Pillows Mask, and MIRAGELIBERTY™ Full Face Mask. Examples of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: International Patent Application WO 2004 / 073,778 (which describes, among other things, aspects of ResMed Limited's SWIFT® Nasal Pillows); U.S. Patent Application No. 2009 / 0044808 (which describes, among other things, aspects of ResMed Limited's SWIFT® LT Nasal Pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe, among other things, aspects of ResMed Limited's MIRAGE LIBERTY™ Full Face Mask); and International Patent Application WO 2009 / 052,560 (which describes, among other things, aspects of ResMed Limited's SWIFT® FX Nasal Pillows).

[0046] 1.2.3.1.2 Positioning and Stabilization The seal-forming structures of patient interfaces used in positive pressure therapy are subject to the corresponding forces of air pressure, which can compromise their seal. Therefore, various techniques have been used to position and maintain the seal-forming structures in sealing relationship with the appropriate portion of the face.

[0047] One technique involves the use of adhesives. See, for example, U.S. Patent Application Publication No. 2010 / 0000534. However, adhesives can be uncomfortable.

[0048] Another technique uses one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following: poor fit, bulk, discomfort, and cumbersomeness.

[0049] One form of the positioning and stabilizing structure includes a pair of gas delivery tubes for receiving airflow from a connection port on the top of the patient's head and for delivering the airflow through the seal-forming structure to the entrance of the patient's airways. In embodiments, the gas delivery tubes may be fabricated from silicone.

[0050] A fabric sleeve may be placed over the gas delivery tube to prevent contact between the tube surface and the patient's face. However, because the sleeve is typically opaque, its use may prevent the patient from visually verifying the cleanliness of the gas delivery tube. The inability to verify the cleanliness of the device, particularly the components within the airflow path, can cause discomfort to the patient when using the device.

[0051] When a woven sleeve is deployed, it may be desirable for the sleeve to be permanently connected to the gas delivery tube so that the sleeve does not bunch (bundle or wrinkle), curl, or move away from its correct position on the tube. However, the presence of the sleeve should not affect the elastic extensibility of the tube, and the sleeve (when deployed) should fit comfortably against the patient's skin.

[0052] 1.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to deliver one or more of the therapies described above, for example, by actuating the device to generate a flow of air delivery to an interface to the airway. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). As such, RPT devices can also function as flow therapy devices. RPT devices include CPAP devices and mechanical ventilators.

[0053] Air pressure generators are known for a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical applications have specific requirements that are not met by more common air pressure generators, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical treatment may suffer from shortcomings including one or more of comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0054] One example of a special requirement for a particular RPT device is acoustic noise.

[0055] Table of noise output levels for conventional RPT devices (measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744, one sample only)

[0056] [Table 1]

[0057] A known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed Stellar™ series of adult and pediatric ventilators) can provide invasive and non-invasive independent ventilation support for a range of patients to treat many conditions (e.g., including, but not limited to, NMD, OHS, and COPD).

[0058] The ResMed Elis Accent-Aiguée® 150 ventilator and ResMed VS III™ ventilator can provide invasive and non-invasive dependent ventilatory support suitable for adult or pediatric patients for the treatment of multiple medical conditions. These ventilators offer volumetric and pressure ventilation modes using single or dual limb circuits. RPT devices typically include a pressure generator, such as an electric blower or compressed gas reservoir, and are configured to deliver airflow to the patient's airway. In some cases, the airflow can be delivered to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface, as described above.

[0059] A device designer may be presented with a myriad of choices. Often, conflicting design criteria may make certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of a particular implementation may be significantly affected by small changes in one or more parameters.

[0060] 1.2.3.3 Air Circuit An air circuit is a conduit or tube constructed and arranged so that, in use, airflow travels between two components of a respiratory treatment system (e.g., an RPT device and a patient interface). In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb of the air circuit is used for both inhalation and exhalation.

[0061] 1.2.3.4 Humidifier Delivery of airflow without humidification can lead to dryness of the airway. When a humidifier is used with an RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing patient airway comfort. In cooler climates, the additional application of warm air to the entire facial area around the patient interface can provide greater comfort than cool air. Therefore, humidifiers often have the ability to humidify the airflow in addition to heating it.

[0062] Although various artificial humidification devices and systems are known, these may not meet the special requirements of a medical humidifier.

[0063] Medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to the ambient air when needed, typically while a patient is sleeping or resting (e.g., in a hospital). Bedside medical humidifiers may be small. Medical humidifiers may be configured to only humidify and / or heat the airflow delivered to a patient without humidifying and / or heating the patient's ambient environment. For example, while room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can humidify the air inhaled by a patient, these systems may also humidify and / or heat the entire room, which may cause discomfort to the occupant. Furthermore, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0064] Although many medical humidifiers are known, these humidifiers suffer from one or more drawbacks: some medical humidifiers provide insufficient humidification, while others are difficult or inconvenient for the patient to use.

[0065] 1.2.3.5 Ventilation technology Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., ambient).

[0066] The vent may include an orifice through which gas can flow when the mask is in use. Many such vents are noisy. Others may become blocked during use, resulting in insufficient pumping. Some vents may disrupt the sleep of the patient's bed companion 1100, for example, due to noise or concentrated airflow.

[0067] ResMed Limited has developed several improved mask ventilation technologies, see International Patent Application Publication No. WO 1998 / 034,665, International Patent Application Publication No. WO 2000 / 078,381, U.S. Patent No. 6,581,594, U.S. Patent Application Publication No. 2009 / 0050156, U.S. Patent Application Publication No. 2009 / 0044808.

[0068] Conventional mask noise table (ISO17510-2:2007, 10cmH2O pressure at 1m)

[0069] [Table 2]

[0070] [Table 3]

[0071] (*Measured using only one sample at 10cmH2O in CPAP mode using the test method specified in ISO3744)

[0072] The sound pressure values ​​for various subjects are listed below. [Table 4] Summary of the Invention [Means for solving the problem]

[0073] The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0074] A first aspect of the present technology relates to devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders.

[0075] Another aspect of the present technology relates to methods for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders.

[0076] An aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.

[0077] One form of the present technology involves a patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway and to seal and deliver airflow at the therapeutic pressure; and a positioning and stabilizing structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0078] 10. One form of the present technology includes a patient interface, the patient interface comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an airflow at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways, so as to, in use, sealingly deliver an airflow at a therapeutic pressure of at least 6 cmH2O above ambient pressure, throughout the patient's respiratory cycle, the seal-forming structure having an aperture for delivering the airflow at said therapeutic pressure to an entrance of at least one of the patient's nares, the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure in the pressure chamber throughout the patient's respiratory cycle; and a positioning and stabilizing structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airways, so as to, in use, sealingly deliver an airflow at a therapeutic pressure of at least 6 cmH2O above ambient pressure to at least the patient's nares, throughout the patient's respiratory cycle.

[0079] One form of the present technology comprises a positioning and stabilizing structure that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head.

[0080] One form of the present technology includes an elongated woven sleeve that is placed around a gas delivery tube and that is positioned to contact the patient's face in use, and that includes a wall with an opening that allows the patient to observe a portion of the gas delivery tube when the positioning and stabilizing structure is not in use.

[0081] One aspect of the present technology provides a positioning and stabilizing structure that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways to sealingly deliver a flow of pressurized air to at least the patient's nares at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle, the positioning and stabilizing structure receiving an airflow from a connection port on the top of the patient's head and delivering the airflow through the seal-forming structure to the entrance of the patient's airways, the positioning and stabilizing structure including a gas delivery tube constructed and arranged to contact at least one area of ​​the patient's head above an upper ear base point in use, and an elongated textile sleeve disposed around the gas delivery tube and arranged to contact the patient's face in use, the elongated textile sleeve including a wall having an opening that allows a portion of the gas delivery tube to be observed by the patient when the positioning and stabilizing structure is not in use.

[0082] In some embodiments, a) the fabric sleeve is elastic and flexible (can bend elastically) in the axial direction; b) the fabric sleeve is elastic and flexible (can bend elastically) in the circumferential direction; c) the fabric sleeve is more flexible in the axial direction than in the circumferential direction; d) the opening is substantially elliptical, oval, or stadium-shaped; e) the gas delivery tube includes a corrugated portion and a non-corrugated portion, the non-corrugated portion being located opposite the connection port of the corrugated portion, and the fabric sleeve is positioned such that the entire edge of the opening is located over the non-corrugated portion of the gas delivery tube; f) the sleeve extends to the end of the non-corrugated portion of the gas delivery tube opposite the corrugated portion; g) the gas delivery tube includes a strap-engaging portion that engages with a strap, and the fabric sleeve is positioned such that the strap-engaging portion protrudes through the opening; h) the strap-engaging portion includes a tab; i) a gap exists between the edge of the opening and the strap-engaging portion; and j) the gap is in the longitudinal direction. k) The gap allows the gas delivery tube to expand and contract in use without the strap-engaging portion contacting the edge of the opening. 1) The length of the opening is approximately 65 mm. m) The length of the opening is less than 65 mm. n) There is a lateral gap of less than 5 mm between the tab and each side edge of the opening. o) The width of the opening is less than 50% of the circumference of the gas delivery tube when measured at the same longitudinal position on the opening and the tube. p) The positioning and stabilizing structure includes a second strap-engaging portion, and the woven sleeve includes a second opening, and the woven sleeve is positioned such that the second strap-engaging portion protrudes through the second opening. q) The positioning and stabilizing structure includes a second gas delivery tube, and the woven sleeve extends across the two gas delivery tubes. r) The woven sleeve includes a first material located on the patient-contacting side of the sleeve and a second material located on the non-patient-contacting side of the sleeve. s) The first material is connected to the second material via a seam, the seam configured to allow expansion and contraction in the circumferential direction. t) the first material comprises a moisture-wicking core knit material; u) the second material has a smooth surface; v) a seam tape is disposed on the edge of the opening to reduce or eliminate abrasion on the fabric; and w) the fabric sleeve comprises a connection port opening configured to allow an air circuit or elbow to be connected to the connection port during use.x) the textile sleeve includes a seam tape disposed on the edge of the connection port opening, and / or y) the seam tape disposed on the edge of the connection port opening is disposed on the inner surface of the textile sleeve.

[0083] Another aspect of the present technology includes a positioning and stabilizing structure that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airways to sealingly deliver a flow of pressurized air to at least the patient's nares at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle, the positioning and stabilizing structure receiving an airflow from a connection port on the top of the patient's head and delivering the airflow through the seal-forming structure to the entrance of the patient's airways, the positioning and stabilizing structure including a gas delivery conduit constructed and arranged to contact at least one area of ​​the patient's head above the supra-ear base point in use, and the positioning and stabilizing structure further including an elongated woven sleeve disposed around the gas delivery conduit and arranged to contact the patient's face in use, the elongated woven sleeve comprising a flexible single-piece knitted and / or woven structure that is resiliently and flexibly configured in both circumferential and axial directions.

[0084] In some examples, a) the woven sleeve includes a body structure and one or more functional regions knitted and / or woven into the body structure, each functional region having one or more fabric characteristics different from the body structure; b) at least one of the functional regions is a transparent or translucent region that allows at least a portion of the gas delivery tube to be visible; c) the one or more fabric characteristics include one or more of knit density, weave, number of loops in a predetermined knit pattern, knit or weave pattern, yarn density, yarn type, and fiber cross-section; d) at least a portion of the woven sleeve is coated or impregnated with at least one material that imparts functional and / or aesthetic properties; e) at least one of the materials is one or more of a phosphorescent material, a fluorescent material, or an antimicrobial composition; f) the woven sleeve is more flexible axially than circumferentially; g) the gas delivery tube includes a strap-engaging portion, the woven sleeve having a first opening, at least a portion of the strap-engaging portion being available for engagement with a strap through the first opening; and h) the strap-engaging portion includes a tab. i) the positioning and stabilizing structure includes a second strap-engaging portion, and the woven sleeve includes a second opening, through which the second strap-engaging portion is available for engagement with a strap; j) the positioning and stabilizing structure includes a second gas delivery tube, and the woven sleeve extends across the two gas delivery tubes; k) the woven sleeve includes a connection port opening configured to allow an air circuit or elbow to be connected to the connection port in use; l) the first opening is substantially oval, elliptical, or stadium-shaped, and / or the second opening, if present, is substantially oval, elliptical, or stadium-shaped; m) at least one of the first opening, the second opening, and the connection port opening includes an edge reinforcement structure to reduce or eliminate abrasion of the fabric; and / or n) the edge reinforcement structure includes one or more of seam tape, stitching, thermal seal, thickened area, and end cap.

[0085] Another form of the present technology includes a woven sleeve of a positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure including a gas delivery tube that receives an airflow from a connection port on the top of the patient's head and delivers the airflow through the seal-forming structure to an entrance to the patient's airway, the woven sleeve fitting around the gas delivery tube and positioned to contact the patient's face in use, the woven sleeve comprising a single piece knit and / or woven structure that is elastic and flexible both circumferentially and axially.

[0086] In some examples, (a) the woven sleeve includes a body structure and one or more functional regions knitted and / or woven into the body structure, each functional region having one or more fabric characteristics different from the body structure; (b) at least one of the functional regions is a transparent or translucent region that allows at least a portion of the gas delivery tube to be visible when the woven sleeve is attached to the positioning and stabilizing structure; (c) the one or more fabric characteristics include one or more of knit density, weave density, number of loops in a predetermined knit pattern, knit or weave pattern, yarn density, yarn type, and fiber cross-section; (d) at least a portion of the woven sleeve is coated or impregnated with at least one material that imparts functional and / or aesthetic properties; (e) the at least one material is a phosphorescent material, a fluorescent material, or an antimicrobial composition; and (f) the woven sleeve is more flexible axially than circumferentially. g) the woven sleeve has a first opening, such that when the woven sleeve is attached to the gas delivery tube, at least a portion of the strap-engaging portion of the gas delivery tube is accessible for engagement with the strap through the first opening; h) the strap-engaging portion includes a tab; i) the woven sleeve includes a second opening, such that when the woven sleeve is attached to the gas delivery tube, a second strap-engaging portion of the gas delivery tube is accessible for engagement with the strap through the second opening; j) the woven sleeve is constructed to extend across the gas delivery tube and the second gas delivery tube of the positioning and stabilizing structure; k) the woven sleeve includes a connection port opening configured to allow an air circuit or elbow to be connected to the connection port in use; l) the first opening is substantially oval, elliptical, or stadium-shaped, and / or the second opening, if present, is substantially oval, elliptical, or stadium-shaped; m) at least one of the first opening, the second opening, and the connection port opening includes an edge reinforcement structure to reduce or eliminate abrasion of the fabric. and / or n) the edge reinforcement structure comprises one or more of seam tape, stitching, thermal bonds, thickened areas, and end caps.

[0087] Another aspect of the present technology includes a positioning and stabilizing structure that provides a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airways to sealingly deliver a flow of pressurized air to at least the patient's nares at a therapeutic pressure of at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle, the positioning and stabilizing structure receiving the airflow from a connection port on the top of the patient's head and delivering the airflow through the seal-forming structure to the entrance of the patient's airways, the positioning and stabilizing structure comprising: at least one gas delivery conduit constructed and arranged to contact at least one area of ​​the patient's head above the supra-ear base point in use; and at least one elongated woven sleeve disposed around at least a portion of said at least one gas delivery conduit and arranged to contact the patient's face in use, the at least one woven sleeve secured to the at least one gas delivery conduit proximal to an end of the at least one gas delivery conduit that is proximal to the seal-forming structure.

[0088] In some examples, a) the textile sleeve is secured to the at least one gas delivery tube by an adhesive; b) a seam tape layer is disposed on an end of the textile sleeve adjacent the gas delivery tube; c) the seam tape is connected to the textile sleeve by an adhesive; d) the at least one textile sleeve is secured to the at least one gas delivery tube by an end cap; e) the end cap extends from an outer surface of the at least one textile sleeve, beyond an end of the at least one textile sleeve, and beyond at least a portion of a rim of the at least one gas delivery tube; f) the end cap includes an annular sidewall and an end flange extending radially inward from the sidewall; g) the sidewall includes at least one adhesive recess; h) the at least one adhesive recess is annular; i) the at least one adhesive recess is offset from an end of the sidewall distal from the end flange; j) the at least one adhesive recess is offset from the end flange; and k) the sidewall includes at least one axial recess extending from an end of the sidewall toward the end flange. l) at least one seam of the woven sleeve is received within the at least one axial recess; m) the at least one seam of the woven sleeve includes a first seam and a second seam, and the at least one axial recess includes a first axial recess and a second axial recess, the first seam being received in the first axial recess and the second seam being received in the second axial recess; n) the end cap includes at least one visual indicator that indicates one or more of an alignment of a connection of the at least one gas delivery tube with respect to the seal-forming structure and a size of the positioning and stabilizing structure; o) the at least one woven sleeve is secured to the at least one gas delivery tube via a localized high-friction interface; p) the localized high-friction interface is provided by a polymer layer between the woven sleeve and the at least one gas delivery tube; q) the polymer layer is a polymer tape; r) the polymer tape is a thermoplastic polyurethane tape; s) the polymer tape is a silicone tape; or t) the polymer layer is a silicone layer. u) the at least one woven sleeve is secured to the at least one gas delivery tube by double sided tape between the at least one woven sleeve and the at least one gas delivery tube;v) the double-sided tape has a silicone adhesive applied to a first side and a non-silicone adhesive applied to a second side; w) the non-silicone adhesive is an acrylic adhesive; x) the at least one woven sleeve is secured to the at least one gas delivery tube by an overmolded end portion; y) the overmolded end portion extends from an outer surface of the at least one woven sleeve, beyond the end of the at least one woven sleeve, and beyond at least a portion of the edge of the at least one gas delivery tube; z) the overmolded end portion includes at least one visual indicator that indicates one or more of the alignment of the connection between the at least one gas delivery tube and the seal-forming structure and the size of the positioning and stabilizing structure; aa) the at least one gas delivery tube is made of an elastomeric material; bb) the at least one gas delivery tube includes a pair of gas delivery tubes, and the woven sleeve extends across two of the gas delivery tubes. cc) at least one woven sleeve is secured to two gas delivery tubes proximal to their respective ends proximal to the seal-forming structure, and / or dd) at least one woven sleeve is also secured to at least one gas delivery tube proximal to the connection port.

[0089] Another form of the present technology includes a patient interface, the patient interface including: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an airflow at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, and to sealedly deliver an airflow at the therapeutic pressure of at least 6 cmH2O above ambient pressure, throughout the patient's respiratory cycle, in use, the seal-forming structure having an aperture for delivering the airflow at said therapeutic pressure to an entrance of at least one of the patient's nostrils, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the pressure chamber throughout the patient's respiratory cycle, in use; and a positioning and stabilizing structure as described in one form of the above technology.

[0090] Another aspect of one form of the present technology is a patient interface that is molded or otherwise constructed with a peripheral shape that is complimentary to the shape of the intended wearer.

[0091] One aspect of the present technology is a method for manufacturing a device.

[0092] One aspect of certain forms of the present technology is a medical device that is easy to use, for example, by individuals without medical training, individuals with limited dexterity or acumen, or individuals with limited experience using such medical devices.

[0093] An aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, for example with soapy water, without the need for special cleaning equipment.An aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0094] Of course, some of the above aspects may form sub-aspects of the present technology, and sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0095] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.

[0096] The present technology is illustrated by way of example and not limitation in the accompanying drawings in which like reference numerals include like elements as follows: [Brief explanation of the drawings]

[0097] [Figure 1A]3.1 Respiratory Treatment System, showing a system including a patient 1000 wearing a patient interface 3000, which takes the form of nasal pillows and receives positively pressurized air supplied by an RPT device 4000. Air from the RPT device 4000 is conditioned in a humidifier 5000 and delivered to the patient 1000 through an air circuit 4170. A bed companion 1100 is also shown. The patient is sleeping in a supine sleeping position. [Figure 1B] A system is shown including a patient 1000 wearing a patient interface 3000. The system takes the form of a nasal mask and receives positively pressurized air supplied by an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 through an air circuit 4170. [Figure 1C] The system is shown to include a patient 1000 wearing a patient interface 3000. The system takes the form of a full face mask and receives positively pressurized air supplied by an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 through an air circuit 4170. The patient is sleeping in a lateral sleeping position. 3.2 Respiratory System and Facial Anatomy [Figure 2A] 1 shows an outline of the human respiratory system, including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] 1 is a diagram of the human upper respiratory tract, including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. [Figure 2C] FIG. 1 is a front view of a face including several features of the surface anatomy, including upper lip, vermilion, lower lip, mouth width, medial canthus, ala of the nose, nasolabial folds, and cheilion. The superior, inferior, radially medial, and radially lateral directions are also indicated. [Figure 2D] A side view of the head including several features of the surface anatomy including the glabella, serrion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior ear base points. The directions of superior and inferior, anterior and posterior are also indicated. [Figure 2E]

[0023] Figure 1 is a further lateral view of the head, showing the approximate locations of the Frankfort horizontal and nasolabial angle. The coronal view is also shown. [Figure 2F] A bottom view of the nose including several features including the nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, major axis of the nostrils and midsagittal plane. [Figure 2G] FIG. 1 is a side view of the surface features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose, including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibro-adipose tissue. [Figure 2I] The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention paid to the septal cartilage and the medial crus of the greater alar cartilage. [Figure 2J] FIG. 1 is a frontal bony view of the skull, including the frontal, nasal, and cheekbones, showing the nasal turbinates along with the maxilla and mandible. [Figure 2K] This is a side view of the skull, showing the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius. [Figure 2L] Shows the anterolateral aspect of the nose. 3.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C is a schematic cross-sectional view of the structure taken at a point, with the outward normal at this point shown, and the curvature at this point having a positive sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3C] 3B is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point has a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D]A schematic cross-section of a structure cut at a point, showing the outward normal at this point, and the curvature value at this point is zero. [Figure 3E] 3F is a schematic cross-sectional view of the structure taken at a point, with the outward normal at this point shown, and the curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3F] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. 3E. [Figure 3G] 1 shows a mask cushion including two pillows, the outer surface of the cushion, the edge of the surface, and the dome and saddle regions. [Figure 3H] Shown is a mask cushion. Shown is the outer surface of the cushion. Shown is the edge of the surface. Shown is the path on the surface between points A and B. Shown is the linear distance between A and B. Shown are the two saddle regions and the dome region. [Figure 3I] The surface of a structure is shown, with a one-dimensional hole drilled into the surface. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J] 3B is a cross-sectional view through the structure of Figure 3I. The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. 3I are also shown. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] 3L is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left-hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] The right ear is shown, including the right ear helix. [Figure 3S] Shows a right-handed spiral. [Figure 3T] 1 is a diagram of a mask including the signature of the twist of the space curve defined by the edge of the sealing membrane in different regions of the mask. [Figure 3U] FIG. 32 is a view of the plenum chamber 3200 showing the sagittal and medial contact planes. [Figure 3V] A posterior view of the plenum chamber of Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 3V, a sagittal plane bisects the plenum chamber into a left-hand side and a right-hand side. [Figure 3W] 3V is a cross-sectional view through the plenum chamber of FIG. 3V, where the cross-section is taken in the sagittal plane shown in FIG. 3V. The "central contact" plane is shown. The central contact plane is perpendicular to the sagittal plane. The orientation of the central contact plane corresponds to the orientation of the chord 3210. The chord 3210 rests on the sagittal plane and contacts only the cushion of the plenum chamber at two points on the sagittal plane (i.e., upper point 3220 and lower point 3230). Depending on the geometry of the cushion in this region, the central contact plane may contact both the upper and lower points. [Figure 3X] The plenum chamber 3200 of Figure 3U is shown in a use position on the face. The sagittal plane of the plenum chamber 3200 generally coincides with the mid-sagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face plane" when the plenum chamber is in the use position. In Figure 3X, the plenum chamber 3200 is that of a nasal mask, with the upper point 3220 located approximately on the selion and the lower point 3230 located on the upper lip. [Figure 4] 3.4 An example of a patient interface according to the present technology. [Figure 5] FIG. 10 is a perspective view of a patient interface including a woven sleeve in accordance with one form of the technology, positioned in an orientation of use; [Figure 6]FIG. 134 is a top view of a positioning and stabilizing structure with a woven sleeve in accordance with one form of the present technology. [Figure 7] FIG. 134 is a bottom view of a positioning and stabilizing structure with a woven sleeve in accordance with one form of the present technology. [Figure 8] 1 shows an enlarged top view of a gas delivery tube of a positioning and stabilizing structure, showing the opening edge of a woven sleeve in accordance with one embodiment of the present invention, with the remainder of the woven sleeve omitted for clarity. [Figure 9] FIG. 13 is a close-up view of a connection port opening of a woven sleeve in accordance with one form of the present technology. [Figure 10] FIG. 134 is a bottom view of a woven sleeve in accordance with one form of the present technology. [Figure 11] FIG. 10 is a perspective view of a patient interface including a pair of woven sleeves in accordance with one form of the present technology. [Figure 12] FIG. 10 is a perspective view of a woven sleeve in accordance with one form of the present technology. [Figure 13A] 1 is a schematic diagram of an exemplary weave pattern for a woven sleeve in accordance with aspects of the present technology; [Figure 13B] 1 is a schematic diagram of an exemplary weave pattern for a woven sleeve in accordance with aspects of the present technology; [Figure 13C] 10 is a schematic diagram of another exemplary weave pattern for a woven sleeve in accordance with aspects of the present technology; [Figure 14A] FIG. 10 is a first rear perspective view of an end cap for a positioning and stabilizing structure in accordance with one form of the present technology. [Figure 14B] FIG. 14B is a second rear perspective view of the end cap of FIG. 14A. [Figure 14C] FIG. 14B is a rear view of the end cap of FIG. 14A. [Figure 14D] FIG. 14B is a front view of the end cap of FIG. 14A. [Figure 14E] FIG. 14B is a front perspective view of the end cap of FIG. 14A. [Figure 14F] FIG. 14B is a side view of the end cap of FIG. 14A. [Figure 14G] FIG. 14B is an enlarged cross-sectional side view of the end cap of FIG. 14A. [Figure 15]13 shows a cross section of a gas delivery tube and woven sleeve end cap applied to a positioning and stabilizing structure in accordance with one form of the present technology. [Figure 16A] FIG. 144 is a top perspective view of an end cap for a positioning and stabilizing structure in accordance with one form of the present technology; [Figure 16B] FIG. 16B is a top view of the end cap of FIG. 16A. [Figure 17A] 1 is a cross-sectional schematic illustration of an overall positioning and stabilization structure having a high friction interface between a gas delivery tube and a woven sleeve in accordance with one form of the present technology; [Figure 17B] 12 is a cross-sectional schematic diagram of an overall alternative positioning and stabilization structure having a high friction interface between a gas delivery tube and a woven sleeve, in accordance with one form of the present technology; [Figure 18] FIG. 10 is a cross-sectional schematic diagram of an overall positioning and stabilizing structure with double-sided tape applied between a gas delivery tube and a woven sleeve in accordance with one form of the present technology; [Figure 19] 1 is a cross-sectional schematic illustration of an overall positioning and stabilizing structure having a shaped end portion applied to a gas delivery tube and a woven sleeve in accordance with one form of the present technology; [Figure 20] FIG. 10 is a cross-sectional schematic illustration of another form of end cap for a gas delivery tube and woven sleeve applied in a positioning and stabilizing structure in accordance with one form of the present technology, where the gas delivery tube is connected to a plenum chamber of a patient interface; [Figure 21] FIG. 13 is a cross-sectional schematic diagram of an overall positioning and stabilizing structure with a seam tape disposed on the end of a woven sleeve in accordance with one form of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0098] Before describing the present technology in further detail, it is to be understood that the present technology is not limited to the specific examples described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein, and is not intended to be limiting.

[0099] 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 may 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 may be arranged into additional examples.

[0100] 4.1 Treatment In one form, the present technology includes a method of treating disordered breathing, the method including applying positive pressure to the entrance of the airways of a patient 1000.

[0101] In a particular example of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0102] In certain instances of the present technology, mouth breathing is restricted, limited, or prevented.

[0103] 4.2 Respiratory Treatment Systems In one form, the present technology includes a respiratory treatment system for treating respiratory disorders. The respiratory treatment system may include an RPT device 4000 for supplying airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0104] 4.3 Patient Interface A non-invasive patient interface 3000 in accordance with one aspect of the present technology includes as functional aspects a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's 1000 airway so as to maintain positive pressure at the entrance to the patient's 1000 airway. As such, the sealed patient interface 3000 is suitable for delivery of positive pressure therapy.

[0105] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0106] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.

[0107] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.

[0108] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient, for example up to 30 cmH2O.

[0109] 4.3.1 Seal formation structure In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may also provide a cushioning function. The target seal-forming area is the area where sealing may occur in the seal-forming structure 3100. The area where sealing actually occurs (i.e., the actual sealing surface) may vary from patient to patient during a given treatment session and from day to day, depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0110] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0111] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0112] A seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material (eg, silicone).

[0113] In certain forms of the present technology, a system is provided that includes a plurality of seal-forming structures 3100, each configured to accommodate a range of different sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 that is suitable for large head sizes but not small head sizes, and another that is suitable for small head sizes but not large head sizes.

[0114] 4.3.1.1 Sealing mechanism In one form, the seal-forming structure includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure in the plenum chamber 3200 acting on its underside to form a tight sealing engagement with the face. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0115] 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., about 0.25 mm to about 0.45 mm) that extends around the periphery 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 periphery of the plenum chamber 3200 and extends around at least a portion of the periphery. The support flange is or includes a spring-like element that functions to support the sealing flange to prevent it from buckling during use.

[0116] In one form, the seal-forming structure may include a compression sealing portion or a gasket sealing portion constructed and arranged to be in compression in use due to, for example, elastic tension in the positioning and stabilizing structure.

[0117] In one form, the seal-forming structure includes a tensioning portion that, in use, is held taut by, for example, an adjacent region of the sealing flange.

[0118] In one form, the seal-forming structure includes an area having a sticky or adhesive surface.

[0119] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension section, and a section having an adhesive or adhesive surface.

[0120] 4.3.1.2 Nasal pillow In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

[0121] Nasal pillows according to one aspect of the present technology include a frustum cone, at least a portion of which forms a seal under the patient's nose, a handle, and a flexible region below the frustum cone that connects the frustum to the handle. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent the base of the handle. The flexible regions can work together to facilitate a universal joint structure that accommodates relative movement (both displacement and angle) between the frustum cone and the structure to which the nasal pillows are connected. For example, the frustum cone can be displaced axially toward the structure to which the handle is connected.

[0122] 4.3.2 Plenum chamber The plenum chamber 3200 has a periphery shaped to be complementary to the surface contours of an average human face in the area where a seal is formed in use. In use, the periphery of the plenum chamber 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire periphery of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single, homogenous piece of material.

[0123] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eye when in use. In other words, the eye is outside the pressurized volume defined by the plenum chamber. Such forms may improve treatment compliance, often resulting in less intrusiveness and / or greater wearer comfort.

[0124] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). The use of a transparent material may reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of a transparent material may help the clinician see the placement and function of the patient interface.

[0125] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material, which can make the patient interface less intrusive and help improve compliance with treatment.

[0126] 4.3.3 Positioning and stabilization structures The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealing position during use by a positioning and stabilising structure 3300.

[0127] In one form, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the effect of the positive pressure of the plenum chamber 3200 separating it from the face.

[0128] In one form, the positioning and stabilising structure 3300 provides a holding force sufficient to overcome the effects of attractive forces on the patient interface 3000.

[0129] In one form, the positioning and stabilizing 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 tube drag or inadvertent interference with the patient interface).

[0130] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0131] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a supine sleeping position with the posterior region of the patient's head resting on a pillow.

[0132] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleeping position with the side region of the patient's head resting on a pillow.

[0133] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a decoupling located between a front portion of the positioning and stabilizing structure 3300 and a rear portion of the positioning and stabilizing structure 3300. The decoupling does not resist compression and can be a flexible or soft strap, for example. The decoupling is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling prevents a posterior force from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0134] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient-contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes loop material that engages with portions of hook material.

[0135] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) strap. For example, the strap can be configured to be tensioned in use to direct a force that urges the seal-forming structure into contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0136] In one form of the present technology, the positioning and stabilizing structure includes a first tie constructed and arranged such that, in use, at least a portion of its lower edge passes over and moves to a superior-auricular point on the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0137] In one form of the present technology, suitable for a nasal-only or full face mask, the positioning and stabilizing structure includes a second tie constructed and arranged such that, in use, at least a portion of its upper edge passes under the inferior ear base point on the underside of the patient's head and covers or rests under the occipital bone of the patient's head.

[0138] In one form of the present technology suitable for a nasal or full face mask, the positioning and stabilizing structure includes a third tie constructed and arranged to interconnect the first tie and the second tie in a manner that reduces the tendency of the first tie and the second tie to move away from one another.

[0139] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps that are bendable, e.g., non-rigid. An advantage of this embodiment is that the straps are more comfortable when the patient is lying down while sleeping.

[0140] In a particular form of the present technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow water vapor to pass therethrough.

[0141] In certain forms of the present technology, a system is provided that includes a plurality of positioning and stabilizing structures 3300. Each positioning and stabilizing structure 3300 is configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large sized heads but not for small sized heads, and another form that is suitable for small sized heads but not for large sized heads.

[0142] In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more gas delivery conduits 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example as shown in FIG.

[0143] In some examples, the positioning and stabilizing structure 3300 includes two 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 stabilizing structure 3300 of the patient interface 3000 and position and stabilize the seal-forming structure 3100 of the patient interface over the appropriate portion of the patient's face (e.g., nose or nose and mouth). This allows the conduit of the air circuit 4170 that provides the flow of pressurized air to be connected to the connection port 3600 of the patient interface at a location other than the front and anterior of the patient's face. While the use of a pair of tubes 3350 has several advantages, in some examples the positioning and stabilizing structure 3300 includes only a single tube 3350 configured to cover one side of the patient's head. A strap or other stabilizing member may be provided between the tip of the single tube 3350 and the seal-forming structure 3100 on the other side of the patient's head to provide a counterbalancing force on the seal-forming structure 3100. Unless otherwise specified, any of the examples of positioning and stabilizing structures described below with reference to FIGS. 5-21 may include a single tube 3350 or two tubes 3350.

[0144] In certain forms of the present technology, at least one of the gas delivery tubes 3350 is constructed and arranged to contact at least one region of the patient's head above the superior ear base point when in use.

[0145] The patient interface 3000 may include a connection port 3600 located proximal to the top, side, or back of the patient's head. For example, in the form of the present technology shown in FIG. 4 , the connection port 3600 is located on the top of the patient's head over the parietal bone. In some examples, the patient interface 3000 includes an elbow 3610 at which the connection port 3600 is located. The elbow 3610 is rotatable relative to the positioning and stabilizing structure 3300 to isolate movement of the conduit connected to the connection port 3600 from the positioning and stabilizing structure 3300. The elbow 3610 may be connected to a fluid connection opening 3360 in a headgear tube 3350 or in a member to which the headgear tube 3350 is connected. Additionally or alternatively, the conduit connected to the connection port 3600 is rotatable relative to the elbow 3610. In the example shown, the elbow 3610 includes a rotating conduit connector including a connection port 3600 connectable such that a conduit of the air circuit 4170 can rotate about its longitudinal axis relative to the elbow 3610. In some examples, the air circuit 4170 can be connected to a fluid connection opening 3360. The elbow 3610 can be rotatably connected to the fluid connection opening 3360 or to a ring housed within the fluid connection opening 3360.

[0146] 4, the two tubes 3350 are integrally formed and include a fluid connection opening 3360 to which a rotating elbow is connected. In other examples, when separate tubes are used, they may be indirectly connected, for example, each tube may be connected to a T-shaped conduit having two conduit arms fluidly connectable to the tube 3350. The crown connector may include a third conduit arm. The connection port 3600 may include an elbow 3610 that is received in the center of the crown connector 3360. The elbow 3610 may be configured to rotate.

[0147] In some examples of the present technology, the tube 3350 is configured to receive the strap 3310 at a position above and proximal to the patient's ear (eg, by providing a strap engaging portion such as a tab 3320).

[0148] In some examples, at least one of the gas delivery tubes 3350 includes a variable length section 3352. The variable length section 3352 is extendable, compressible, or both extendable and compressible from its "rest" or natural length. In some examples, the variable length section 3352 includes at least one undulating or corrugated section 3354. In some examples, the gas delivery tube includes a generally constant length section 3356 extending between the variable length section 3352 and an end 3358 of the gas delivery tube 3350 connected to the plenum chamber connectors 3204, one connector located on each side of the plenum chamber 3200.

[0149] The example shown in FIG. 4 includes a prior art sleeve 3363 .

[0150] 4.3.3.1 Woven sleeve 5-21 , in one form of the present technology at least one elongated woven sleeve 3650 is disposed over the or each gas delivery conduit 3350. The sleeve 3650 is disposed over the gas delivery conduit 3350 such that, in use, at least a portion of the sleeve 3650 contacts the patient's face (e.g., the patient's cheek). In some examples, the sleeve 3650 is configured to cover two gas delivery conduits of the positioning and stabilizing structure 3300, although in other forms of the present technology (not shown), a separate sleeve 3650 may be disposed for each gas delivery conduit 3350.

[0151] In some examples, the sleeve 3650 is positioned over the gas delivery tube 3350 such that a portion 3652 of the sleeve overlaps the generally fixed length portion 3356 of the gas delivery tube 3350 and a portion 3654 of the sleeve overlaps the variable length portion 3352 of the gas delivery tube 3350. This allows portions 3356 and 3352 of the gas delivery tube 3350 to be visible in Figure 4 but hidden by the sleeve 3650 in Figures 5-21.

[0152] 5, in some instances, an opening 3668 is disposed in the wall 3666 of the sleeve 3650. In some instances, the opening 3668 is sized to allow a patient to observe a portion of the gas delivery tube 3350 through the opening.

[0153] In one form of the present technology, a sleeve 3650 is configured for use with a gas delivery tube 3350 that includes a strap engagement portion 3320 (typically formed integrally with the gas delivery tube) for engaging a strap (e.g., a strap), such as in the form of a tab with a loop or hook. The tab 3320 may have a hole 3322 through which a tape can pass for engagement.

[0154] In some examples, the sleeve 3650 is resilient and flexible in an axial direction, where axial direction refers to the direction of a centerline CL of the sleeve 3650, a portion of which is shown in FIG. 6. In some examples, the sleeve 3650 is resilient and flexible in a circumferential direction C. In one form of the present technology, the sleeve 3650 is flexible in both the axial and circumferential directions, and is more flexible in the axial direction than in the circumferential direction C.

[0155] The sleeve 3650 may include a first material 3670 and a second material 3672. The first material 3670 may form a patient-contacting side 3674 of the sleeve 3650, and the second material 3672 may form a non-patient-contacting side 3676 of the sleeve 3650. The first and second materials 3670, 3672 may be connected via stitches 3678. In some examples, at least one of the stitches 3678 is configured to allow for circumferential extension. Examples of suitable stitches include pull-out stitches, overlock stitches, and / or encasement stitches.

[0156] The first material 3670 may be selected to provide good moisture wicking and / or a soft feel. In one example, the first material 3670 includes a knit structure. In various examples, the first material 3670 is dark in color. One example of a suitable material is Merwei JC1937a. The first material 3670 may be, for example, 0.6 mm thick.

[0157] The second material 3672 may be selected to be lubricious to reduce friction when sliding on the bed during use. One example of a suitable material is Gemmaknits IAP 027 AA. The second material 3672 may be, for example, 0.5 mm thick. In examples, both the first and second materials include nylon and spandex.

[0158] In some forms, the woven sleeve 3650 covers the entire length of the gas delivery tube 3350. This may be desirable to improve the aesthetic appearance of the positioning and stabilizing structure 3300 and therefore improve patient compliance with respiratory therapy. In other forms, the woven sleeve 3650 covers only the portion of the gas delivery tube 3350 that typically comes into contact with the patient's skin during use, which may improve patient comfort (by avoiding direct contact with the material of the gas delivery tube 3350, which is typically made of silicone or a similar material).

[0159] In some forms, the woven sleeve 3650 is a substantially tubular structure comprising a single piece knit and / or woven construction that is elastic and flexible in both the circumferential direction C and the axial direction A (these directions are shown in FIG. 11 ). The woven sleeve 3650 may comprise a single layer or more layers. The woven sleeve 3650 may be manufactured in a single knitting operation. If the woven sleeve comprises multiple layers, these layers may be interconnected in a single knitting operation.

[0160] The circumferential elastic flexibility (across the width of the elongated woven sleeve 3650) allows the woven sleeve 3650 to form a tight fit with the gas delivery tube 3350, even though the width of the gas delivery tube 3350 varies along its length. For example, in some forms of the present technology, the gas delivery tube 3350 may be narrower at the proximal end of the fluid connection opening 3360 than at the distal end of the fluid connection opening 3360 and the proximal end of the plenum chamber connector 3204. In this case, when the woven sleeve 3650 is attached to the gas delivery tube 3350, the woven sleeve 3650 contracts to "hugging" the tube 3350 at the proximal portion 3654 and the distal portion 3652. Additionally, the circumferential elastic flexibility allows the sleeve 3650 to stretch over strap-engaging portions of the gas delivery tube 3350, such as the hook tabs 3320.

[0161] In some forms of the present technology, the elasticity of the sleeve 3650 may vary along its length. For example, areas of the sleeve intended to accommodate wider portions of the gas delivery conduit 3350, such as the sleeve portion 3654 or tab 3320 that overlap the variable length portion, may be more elastic than areas intended to accommodate narrower portions of the gas delivery conduit 3350, such as the sleeve portion 3652. Elasticity may be varied, for example, by varying the knit density, weave density, number of loops in the knit, and / or the knit or weave pattern itself.

[0162] When the positioning and stabilizing structure 3300 is worn on a patient and the gas delivery tube 3350 bends as the patient moves, the axial elastic flexibility (along the length of the elongated woven sleeve 3650) tends to reduce or eliminate the possibility of wrinkling of the sleeve 3650.

[0163] Forming the woven sleeve 3650 using a single piece knit and / or woven construction can provide a seamless, more comfortable construction without sharp edges, and minimize or eliminate post-processing steps that are required when the sleeve is manufactured by cutting and joining pieces of material used to form the sleeve.

[0164] The woven sleeve 3650, such as that shown in any of Figures 15-12, can be formed using a programmable knitting or loom machine, such as an electronic twin-needle bed warp knitting machine or needle loom. The use of such machines allows for the woven sleeve 3650 to be imparted with a variety of aesthetic and functional properties in a single manufacturing process.

[0165] For example, when using a loom, the weave can be programmed to provide various pattern configurations, such as twill rearrangements of warp and weft threads, providing comfort against the skin and a more aesthetically pleasing finish.

[0166] When using a knitting machine, different knit patterns can be programmed to change the elasticity, flexibility, and other physical properties of the woven sleeve 3650. This can be done for both single layer and multi-layer sleeves 3650. For multi-layer sleeves 3650, the knitting machine can be programmed to use different yarn parameters, such as different yarn types, yarn densities, yarn compositions, etc., to create texture, texture, or stretch for each layer. For example, for a single layer sleeve 3650, the yarn parameters may be varied in different regions along the length of the woven sleeve 3650.

[0167] In some forms, the fabric sleeve 3650 is at least partially formed from a first synthetic yarn, which may include fibers such as nylon 66, polyester, acrylic, and / or polyolefin.

[0168] The yarn specifications may be selected to obtain various advantages, such as flexibility, surface smoothness and flatness, stretchability, and / or translucency. For example, a relatively low denier yarn may have increased translucency to allow the patient to see through the woven sleeve 3650. Alternatively, a relatively low denier yarn may have flexibility to provide greater patient comfort. Alternatively, the use of a relatively high denier yarn may facilitate ease of manufacturing. The denier of the first composite yarn may be within the range of about 20D to 80D, or about 25D to 75D, or about 30D to 70D, or about 35 to 65D, or about 40 to 60D, or about 45 to 55D.

[0169] Alternatively or additionally, the woven sleeve 3650 may be at least partially formed from a second synthetic yarn, such as a yarn formed from elastane, Lycra™ fiber, Spandex™ fiber, or ROICA™ fiber. The second synthetic yarn may be a high-draw elastomeric yarn having a denier ranging from about 50D to 140D, about 55D to 135D, about 60D to 130D, about 65D to 125D, about 70D to 120D, about 75D to 115D, about 80D to 110D, about 85D to 105D, or about 90D to 100D. The high-draw yarn may contribute to the circumferential elastic flexibility and / or the axial elastic flexibility of the woven sleeve 3650.

[0170] Alternatively or additionally, the textile sleeve may be at least partially formed from a second synthetic yarn, such as a yarn formed from elastane, Lycra™ fiber, Spandex™ fiber, or ROICA™ fiber. The second synthetic yarn may be a high-draw elastomeric yarn having a denier ranging from about 50D to 140D, about 55D to 135D, about 60D to 130D, about 65D to 125D, about 70D to 120D, about 75D to 115D, about 80D to 110D, about 85D to 105D, or about 90D to 100D. The high-draw yarn may contribute to the circumferential elastic flexibility and / or the axial elastic flexibility of the textile sleeve 3650.

[0171] In some forms, the woven sleeve 3650 may be formed at least in part from one or a combination of any two or more of a double jersey construction as shown in FIG. 13A, a plain weave 1×1 construction as shown in FIG. 13B, and a plain weave 2×2 construction as shown in FIG. 13C.

[0172] The woven sleeve 3650 can have a stretch (or elasticity) greater than 100% of its rest length or width (e.g., about 120%-300%). In some forms, the stretch can be about 130% to about 190%, 140% to 180%, or 150% to 170%. The stretch can be greater in some directions than in others. For example, the stretch in the circumferential direction C can be greater than the stretch in the axial direction A.

[0173] In some forms, the woven sleeve 3650 may be stretchable to contract to less than 100% of its rest length (e.g., about 80% of the rest length) or less than 100% of its rest width (e.g., 80% of the rest width). For example, when the woven sleeve 3650 is stretched to more than 100% of its rest length, its rest width may straighten and contract due to tension in the loops within the knit.

[0174] In some forms, the woven sleeve 3650 includes a main body structure and one or more functional regions knitted and / or woven into the main body structure. Each functional region may have one or more textile characteristics that differ from the main body structure. For example, as shown in FIG. 11 , the sleeve 3650 may include a functional region 3660 extending partially along the non-patient-contacting side 3676 of the woven sleeve 3650 and having different textile characteristics than the remainder of the non-patient-contacting side 3676 and patient-contacting side 3674 of the sleeve 3650.

[0175] In some forms, the functional area 3660 may be a transparent or translucent area that allows at least a portion of the gas delivery conduit 3350 to be visible. This allows the patient to observe portions of the gas delivery conduit 3350 when the positioning and stabilizing structure is not in use and can prompt the patient to clean the gas delivery conduit 3350 if dust or other particulate matter is observed within the gas delivery conduit 3350.

[0176] The transparent or translucent region 3660 may be formed by knitting or weaving portions of the sleeve 3650 with a low density yarn or combination of yarns, a low density knit or weave pattern, or yarns formed from certain fiber types (e.g., synthetic monofilament or multifilament yarns formed from fibers having a flattened cross section) during the manufacturing process of the sleeve 3650. Suitable types of yarns are described in U.S. Patent Publication No. 20040168479, the entire contents of which are incorporated herein by reference.

[0177] 11 does not show a single transparent or translucent region 3660, it should be understood that multiple such regions may be formed along the length of the woven sleeve 3650. In some instances, the entire non-patient-contacting side 3676 of the woven sleeve 3650 may be transparent or translucent.

[0178] In some forms of the present technology, one or more functional regions may be reinforced comfort regions to improve patient comfort. For example, a majority (e.g., the portion of the sleeve 3650 that contacts the patient during normal use) or all of the patient-contacting side 3674 of the woven sleeve 3650 may be formed as an reinforced comfort region. To this end, the reinforced comfort region may include one or more textured yarns that provide softness, thermal comfort, and breathability. The textured yarn may, for example, be a flat-lay construction made up of multiple fibers of different cross-sections.

[0179] In some forms, at least one area of ​​enhanced friction in one or more functional areas may include a twill weave for localized grip in the at least one area of ​​enhanced friction.

[0180] In some configurations, one or more areas may be formed with a woven pattern to achieve a particular aesthetic effect, such as a woven ribbon with full but offset blinds, or a V-woven velvet ribbon for a smooth appearance.

[0181] In some forms, the woven sleeve 3650 may be formed as a low friction structure to facilitate attachment to the gas delivery tube 3350. For example, the thread density and fiber cross section may be selected to provide a low friction surface for the sleeve 3650.

[0182] In some forms, the woven sleeve 3650 may be provided to the patient as a separate item (e.g., as part of a kit or as a replacement item) to be attached to the gas delivery tube 3350. The woven sleeve 3650 may have markings to inform the patient of the correct orientation for attaching the sleeve 3650 to the tube 3350. Such markings may take the form of text or graphics, and / or a color and / or pattern, indicating that one side is the patient-contacting surface 3674 and the other side is the non-patient-contacting surface 3676.

[0183] In some examples, at least a portion of the woven sleeve 3650 is coated or impregnated with at least one material that imparts functional and / or aesthetic properties. For example, the woven sleeve 3650 may be coated or impregnated (e.g., by printing or impregnating the yarn fibers prior to knitting or weaving the woven sleeve 3650) with a "glow in the dark" material (e.g., a phosphorescent or fluorescent material). In some examples, the woven sleeve 3650 may be coated or impregnated with an antimicrobial composition to reduce or eliminate odors or discoloration caused by absorbing sweat or other contaminants during use.

[0184] In one form of the present technology, the sleeve 3650 is configured to allow the strap engaging portion 3320 to extend through the opening 3668. The opening 3668 may expose the entire strap engaging portion 3320 or only the hole 3322 in the strap engaging portion 3320, as shown in FIGS.

[0185] In some forms, the sleeve 3650 may include one or more such openings, for example, when a single sleeve 3650 is positioned to extend over two gas delivery tubes 3350. In this case, the sleeve 3650 may further include a connection port opening 3680 configured to allow an air circuit 4170 or elbow 3600 to be connected to the connection port 3360, as best shown in FIG.

[0186] 8 , in some examples, the opening 3668 has a length L that is greater than a length B of the base of the strap-engaging portion 3320 measured parallel to the longitudinal or central axis of the gas delivery conduit 3350. In some examples, the width of the opening 3668 is greater than a width of the base of the strap-engaging portion 3320 measured perpendicular to the longitudinal or central axis of the gas delivery conduit 3350. In some examples, the gap CB between the base of the strap-engaging portion 3320 and the edge 3669 of the opening 3668 is at least sufficient to allow a patient to grasp the fabric material around the opening 3668 (e.g., between a finger and thumb in a pinching motion) and at least pull the material at the edge 3669 of the opening 3668 away from the gas delivery conduit 3350 to allow observation of a portion of the tubing 3350 that would otherwise be covered by the sleeve 3650. This allows the patient to visually check the cleanliness of the gas delivery tubing 3350 without removing the fabric sleeve from the tubing.

[0187] The opening 3668 may have sufficient clearance CB from the base of the strap engaging portion 3320 to allow the gas delivery tube 3350 to move within the sleeve 3650 without being restricted by the strap engaging portion 3320 abutting the edge 3669 of the opening 3668 (e.g., when the variable length portion is extended).

[0188] In one form of the present technology, such gaps CB are located on either end of opening 3668.

[0189] In one example, the opening 3668 is generally rectangular. In one example, the generally rectangular opening 3668 has arcuate corners. In another example, the opening 3668 is substantially stadium-shaped, i.e., has a pair of parallel sides connected at each end by an arc or semicircle.

[0190] In one form of the present technology, the width of the opening 3668 is less than 50% of the circumference of the gas delivery tube 3350 when two measurements are taken at the same longitudinal location (e.g., the same location on the centerline CL). This ensures that material at the edge of the opening 3668 remains in contact with the gas delivery tube 3350. A wider opening could cause material at the edge 3669 of the opening 3668 to peel away from the gas delivery tube 3350.

[0191] In one example, the opening 3668 is configured to extend a distance D of substantially 7 mm to 8 mm from the edge 3351 of the gas delivery tube 3350 from which the strap engaging portion 3320 extends, as shown in FIG. 8. This edge 3351 may be the bottom edge of the tube 3350 if a positioning and stabilizing structure is used. In various examples, the opening is located substantially entirely on the non-patient-contacting side of the textile sleeve 3650 to avoid or prevent contact between the patient's skin and the surface of the gas delivery tube 3350.

[0192] In one example, the opening 3668 may have a length L of substantially 65 mm. The axial gap distance CB may be substantially 5 mm. The width of the opening may be selected to fit snugly against the side of the base of the strap-engaging portion, such that the gap distance D is less than 5 mm, such as less than 2 mm, such as close to or equal to zero. This narrow gap D can provide a more complete appearance and also helps ensure that the sleeve 3650 does not wrinkle, fold, or become baggy over time.

[0193] In other examples, the length L and distance CB may differ from the values ​​provided above. For example, these values ​​may be changed to accommodate strap joints of different lengths and / or widths, or to increase or decrease the gap. In examples, the length L may be less than 65 mm.

[0194] In one form of the present technology, the sleeve 3650 extends substantially the entire length of the positioning and stabilizing structure, for example over two gas delivery conduits 3350 (shown in FIGS. 5-7 ). In some examples, the positioning and stabilizing structure includes two strap engaging portions 3320, and the sleeve 3650 includes two of the openings 3668 described above. In examples where the sleeve 3650 extends substantially the entire length of the positioning and stabilizing structure, the sleeve 3650 may further include a connection port opening 3680 configured to allow an air circuit 4170 or an elbow 3600 to be connected to a fluid connection opening 3360 of the gas delivery conduit 3350 in use. The connection port opening 3680 may be a substantially circular opening and may be sized to provide clearance around the fluid connection opening 3360 so that an air circuit or elbow can be connected to the fluid connection opening 3360 without interfering with the sleeve 3650.

[0195] In some examples, the material surrounding the end of the sleeve 3650 and / or the edges of each opening 3668, 3680 may be provided with seam tape to reduce or eliminate abrasion of the material.

[0196] In some examples, the openings 3668 can be formed as part of the single piece knit and / or woven construction of the sleeve 3650 in a single manufacturing step so that no post-processing is required to create the openings 3668.

[0197] 11, in some forms, the opening 3668 may include an edge reinforcement structure 3902 to reduce or eliminate abrasion of the fabric sleeve 3650 in the area of ​​the opening 3668 and the connection port opening 3680. The edge reinforcement structure 3902 may be formed by ultrasonic welding, laser cutting, using reinforced seam tape, sewing, heat bonding, or depositing additional material (e.g., a thermoplastic material).

[0198] In one example, the seam tape is bonded by a suitable technique, such as by gluing, to the outer surface of the fabric sleeve 3650. The openings 3668 can then be formed in the seam tape and fabric sleeve 3650 simultaneously.

[0199] A similar technique can be used to apply seam tape around the connection port opening 3680. In some examples, the seam tape is applied to the inner surface of the fabric sleeve 3650. However, in alternative examples, the seam tape is applied to the outer surface of the sleeve 3650.

[0200] 4.3.3.2 Fixing the Fabric Sleeve to the Gas Delivery Pipe 11 , in some examples, the woven sleeve 3650 may further include an edge reinforcement structure 3800 located at a first end proximal to the plenum chamber 3200 and an edge reinforcement structure 3900 located at a second end opposite the first end distal to the plenum chamber 3200. The edge reinforcement structure 3800 and / or the edge reinforcement structure 3900 may be formed by ultrasonic welding, laser cutting, use of reinforced seam tape, stitching, thermal bonding, or deposition of additional material (e.g., a thermoplastic material).

[0201] In examples, the woven sleeve 3650 may be secured to the gas delivery tube 3350 near the connection port 3600, i.e., at or near the fluid connection opening 3360. In such examples, the edge reinforcement structure 3800 may be an end cap, as shown in Figures 14A-14G.

[0202] In some forms of the present technology, the woven sleeve 3650 may be secured to the gas delivery tube 3350 at a position near the end 3358 .

[0203] Securing the sleeve in this manner can help provide stability to the relationship between the woven sleeve 3650 and the gas delivery conduit 3350, particularly during dynamic movements in which the patient forces the woven sleeve 3650 in one direction and the seal-forming structure 3100 or plenum chamber 3200 in another. In this case, it is desirable for the woven sleeve 3650 to be held in place and not dislodged (e.g., rolled or stepped on) from the connection between the gas delivery conduit 3350 and the plenum chamber 3200. While the relative sizes of the woven sleeve 3650 and the gas delivery conduit 3350 can be used to provide a tight fit that resists such movement, the introduction of lubricants (e.g., cleaning detergents) can disrupt this fit, and for at least that reason, it is desirable for a more secure connection to be provided.

[0204] In accordance with one aspect of the present technology, an end cap 3800 is placed on an end 3358 of a gas delivery tube 3350, which end 3358 connects the woven sleeve 3650 to the gas delivery tube 3350. Figure 5 shows such an example.

[0205] 14A-14G illustrate an exemplary end cap 3800. The end cap 3800 includes an annular side wall 3802. As used herein, the term "annular" should be understood to mean a general ring shape, rather than necessarily strictly adherent to a link. That is, the side wall 3802 may have an irregular annular shape. An end flange 3804 extends radially inward from the side wall 3802 and defines an end cap opening 3806 that can receive the plenum chamber connector 3204 in use.

[0206] In some examples, the sidewall 3802 has an end 3808 distal from the end flange 3804 and an inner surface 3810 located between the end 3808 and the end flange 3804. The sidewall 3802 may have at least one annular adhesive recess 3812 disposed on the inner surface 3810. The adhesive recess 3812 may be used to help distribute adhesive around the end cap 3800 and control adhesive spreading before application to the woven sleeve 3650 and the gas delivery tube 3350. In the example of FIGS. 14A-14G, the adhesive recess 3812 is offset from both the end 3808 of the sidewall 3802 and the end flange 3804. In an alternative example, the adhesive recess 3812 may extend all the way to the end 3808 of the sidewall 3802. In another alternative, the adhesive recess 3812 may extend all the way to the end flange 3804.

[0207] In some examples, the side wall 3802 may have at least one axial recess 3814 extending from the end 3808 of the side wall 3802 toward the end flange 3804. The axial recess 3814 may be used to accommodate a seam 3678 of the woven sleeve 3650. In the example of FIGS. 14A-14G, the end cap 3814 includes opposing axial recesses 3814 to accommodate the two seams 3678 of the woven sleeve 3650 shown in FIG. 5.

[0208] In some examples, the end cap 3800 may be secured to the woven sleeve 3650 and the gas delivery tube 3350 using an adhesive, such as silicone. As shown in FIG. 15 , the woven sleeve 3650 may be disposed around the gas delivery tube 3350 proximate the end 3358 of the gas delivery tube 3350. Adhesive is applied to the adhesive recess 3812, and the end cap 3800 is attached to the end 3358 of the gas delivery tube 3350. When attached, the exemplary end cap 3800 extends from the outer surface of the woven sleeve 3650, past the end of the woven sleeve 3650, and past a portion of the rim 3359 of the gas delivery tube 3350 (i.e., the end face of the gas delivery tube 3350). The overlapping portion of the end flange 3804 may help control the spread of the adhesive. The overlapping portion of the end flange 3804 may act as a stop to aid in alignment during installation of the end cap 3800.

[0209] 16A and 16B, the end cap 3800 may have at least one visual indicator 3816 to indicate, for example, the expected alignment of the gas delivery tube 3350 relative to the plenum chamber connector 3204 or the size of the positioning and stabilizing structure 3300. In the illustrated example, the visual indicator 3816 is formed in a side wall 3802 of the end cap 3800. The side wall 3802 may have an extension tab 3818 to accommodate the visual indicator 3816.

[0210] 20, an end cap is provided that does not have an end flange 3804. In some examples, the woven sleeve 3650 extends only up to the adhesive recess 3812, but does not extend beyond the adhesive recess 3812 towards the rim 3359 (i.e., the end of the tube 3350).

[0211] The inner surface 3810 has a first inner surface portion 3810A that extends between the adhesive recess 3812 and the end of the tube 3350, and a second inner surface portion 3810B that extends between the end 3808 and the adhesive recess.

[0212] The first inner surface portion 3810A is sized to fit snugly against the tube 3350, and the second inner surface portion 3810B is sized wider as it is designed to accommodate the sleeve 3650.

[0213] The fit between the inner surface portion 3810a and the tube 3350 prevents adhesive from leaking out the end of the end cap 3800 during the manufacturing process.

[0214] In this example, adhesive provided in adhesive recess 3812 bonds sleeve 3650 to tube 3350 and bonds end cap 3800 to tube 3350 and sleeve 3650 .

[0215] According to another aspect of the present technology, the woven sleeve 3650 is secured to the gas delivery tube 3350 via a localized high-friction interface. At the localized high-friction interface, relative movement between the woven sleeve 3650 and the gas delivery tube 3350 is limited by an increased degree of friction therebetween. This is envisioned to be achieved by providing localized regions with different material properties on the woven sleeve 3650, although in alternative examples, the localized regions may be located on the gas delivery tube 3350. In the example of FIG. 17A , the localized high-friction interface is provided by a discrete polymer layer 3850 between the woven sleeve 3650 and the gas delivery tube 3350. In some examples, the discrete polymer layer 3850 may be provided by a thermoplastic polyurethane (TPU) tape or a silicone tape. In some examples, the silicone tape may be applied to the inner and outer surfaces of the woven sleeve 3650.

[0216] In an alternative example, the discrete polymer layer 3850 may be provided by applying an uncured silicone layer onto the woven sleeve 3650 (e.g., by screen printing) and curing the silicone to achieve the desired properties. In the example shown in Figure 17B, the woven sleeve 3650 may have a silicone layer 3852 printed on both the inner and outer surfaces.

[0217] According to another aspect of the present technology, as shown in FIG. 18 , the woven sleeve 3650 may be secured to the gas delivery tube 3350 by double-sided tape 3854 between the woven sleeve 3650 and the gas delivery tube 3350. In various examples, the double-sided tape 3854 may have a silicone adhesive applied to a first side facing the gas delivery tube 3350 and a non-silicone adhesive (e.g., an acrylic adhesive) applied to a second side facing the woven sleeve 3650. One example of a suitable double-sided tape is "Silicone Rubber Adhesive Double-Sided Tape No. 5303W" available from Knitdenco. Another example of a suitable double-sided tape is "adt-x" tape available from VVB-Birzer Fla(ar-umlaut)chenschutz GmbH. It is envisioned that the double-sided tape 3854 is applied to the gas delivery tube 3350 before the woven sleeve 3650 is pulled or reeled into place.

[0218] 19 , the woven sleeve 3650 may be secured to the gas delivery tube 3350 by an overmolded end portion 3860. The overmolded end portion 3860 includes an annular sidewall 3862 extending along the outer surface of the woven sleeve 3650 and an end flange 3864 extending radially inward from the sidewall 3862 over the end of the woven sleeve 3650 and a portion of the rim 3359 of the gas delivery tube 3350. In alternative examples, the overmolded end portion 3860 extends beyond the rim 3359 into the interior of the gas delivery tube 3350. In various examples, the overmolded end portion 3860 may be formed of a highly durable silicone.

[0219] 21 , the woven sleeve 3650 may extend to the end of the tube 3350 and may be connected to the end of the tube 3350 by an adhesive layer 3813. A layer of seam tape 3920 may be placed on the woven sleeve 3650 at the end of the tube 3350. The seam tape 3920 may be secured to the woven sleeve 3650 by a second layer of adhesive 3813.

[0220] In some examples, a notch (not shown) can be provided in the end of the woven sleeve 3650. The notch makes it easier to roll up the end of the sleeve 3650 before depositing the adhesive layer onto the tube 3350. However, in alternative examples, a notch is not required.

[0221] 4.3.4 Ventilation section In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow the expulsion of exhaled gases, for example carbon dioxide.

[0222] In certain forms, the vent 3400 is configured to allow continuous airflow from the interior of the plenum chamber 3200 to the ambient while the pressure within the plenum chamber is positive relative to the ambient. The vent 3400 is configured such that the magnitude of the airflow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining therapeutic pressure within the plenum chamber in use.

[0223] Ventilation section 3400 in one embodiment according to the present technology includes a plurality of holes (eg, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0224] The vent 3400 may be located on the plenum chamber 3200. Alternatively, the vent 3400 is located within a decoupling structure, such as a swivel.

[0225] 4.3.5 Decoupling structure(s) In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0226] 4.3.6 Connection Port The connection port 3600 allows connection to the air circuit 4170 .

[0227] 4.3.7 Forehead support In one form, the patient interface 3000 includes a forehead support 3700 .

[0228] 4.3.8 Anti-asphyxiation valve In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0229] 4.3.9 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows a property (e.g., pressure) of the gas within the plenum chamber 3200 to be measured directly.

[0230] 4.4RPT Device An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical arrangement elements and is configured to execute one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, for example, to treat one or more of the respiratory conditions described elsewhere herein.

[0231] In one form, the RPT device 4000 is constructed and arranged to be capable of delivering an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0232] 4.5 Air Circuit The air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged to allow airflow to travel between two components of a respiratory treatment system (e.g., the RPT device 4000 and the patient interface 3000) when in use.

[0233] In particular, the air circuit 4170 may be fluidly connected to the outlet of the air block and the patient interface. The air circuit may also be referred to as an air delivery tube. In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb is used.

[0234] In some forms, the air circuit 4170 may include one or more heating elements arranged to heat the air in the air circuit, for example, to maintain or increase the temperature of the air. The heating elements may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. The heating wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller, such as a central controller. One example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent No. 8,733,349, which is incorporated herein by reference in its entirety.

[0235] 4.6 Humidifier 4.6.1 Humidifier Overview In one form of the present technology, there is provided a humidifier 5000 that alters the absolute humidity of air or gas delivered to a patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of the air stream before delivery to the patient's airways.

[0236] The humidifier 5000 can include a humidifier container, a humidifier inlet that receives an air flow, and a humidifier outlet that delivers a humidified air flow.

[0237] 4.7 Respiratory Therapy Mode The disclosed respiratory treatment system is capable of providing a variety of respiratory treatment modes, including CPAP and dual level therapy.

[0238] 4.8 Terminology For purposes of this disclosure, in certain aspects of the technology, one or more of the following definitions may apply. In other aspects of the technology, alternative definitions may apply.

[0239] 4.8.1 General Air: In certain forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, for example, oxygen-enriched atmospheric air.

[0240] Surrounding: In certain forms of the present technology, the term surrounding is considered to mean (i) external to the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.

[0241] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier, such as the humidity of the room the patient is sleeping in. Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0242] In another example, ambient pressure can be the pressure immediately surrounding or external to the body.

[0243] In certain embodiments, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room in which the patient is located, other than noise generated by the RPT device or emanating from the mask or patient interface, for example. Ambient noise may be generated by sources outside the room.

[0244] Automatic Positive Airway Pressure (APAP) Therapy: A CPAP therapy in which the therapy pressure is automatically adjustable, eg, breath-to-breath, between minimum and maximum limits, depending on the presence or absence of signs of an SDB episode.

[0245] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout a patient's respiratory cycle. In some forms, the pressure at the entrance to the airways is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure varies during different respiratory cycles of the patient, for example, increasing in response to the detection of an indication of partial upper airway obstruction and decreasing in the absence of an indication of partial upper airway obstruction.

[0246] Flow Rate: The amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, a reference to flow rate is to a scalar quantity, i.e., a quantity that has only magnitude. In other cases, a reference to flow rate is to a vector quantity, i.e., a quantity that has both magnitude and direction. Flow rate may be given the symbol Q. "Flow rate" may also be written simply as "flow" or "air flow."

[0247] In the example of a patient breath, the flow rate may be nominally positive for the inspiratory portion of the patient's respiratory cycle and negative for the expiratory portion of the patient's respiratory cycle. Device flow rate Qd is the flow rate of air leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gases that arrives at the patient interface via the air circuit. Vent flow rate Qv is the flow rate of air leaving the vent to allow for the pushing out of exhaled gases. Leak flow rate Ql is the flow rate of leakage from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air admitted to the patient's respiratory system.

[0248] Flow Therapy: Respiratory therapy that involves delivering airflow to the entrance of the airways at a controlled flow rate, called the therapeutic flow rate, that is typically positive throughout the patient's respiratory cycle.

[0249] Humidifier: The word humidifier is taken to mean a humidifying device positioned, installed, or physically constructed to provide a therapeutically beneficial amount of water (H2O) vapor to an air stream to improve the medical respiratory condition of a patient.

[0250] Leak: The word leak refers to unintentional airflow. In one example, a leak can occur as a result of an imperfect seal between the mask and the patient's face. In another example, a leak can occur at the swivel elbow around the area.

[0251] Conducted (acoustic) noise: Conducted noise, as used herein, refers to noise carried to the patient by pneumatic pathways, such as the air circuit and patient interface, and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0252] Radiated (acoustic) noise: Radiated noise herein refers to noise carried to the patient by the surrounding air. In one form, radiated noise can be quantified by measuring the volume / pressure level of the object in question according to ISO 3744.

[0253] Ventilation (acoustic) noise: Ventilation noise herein refers to noise generated by airflow through any vents, such as the vents of a patient interface.

[0254] Patient: A human being, whether or not suffering from a respiratory condition.

[0255] Pressure: Force per unit area. Pressure is measured in cmH2O or gf / cm 2 , and hectopascals. 1 cmH2O is 1 g-f / cm 2 is equal to approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m 2 = 1 mbar to 0.001 atm). In this specification, pressures are given in units of cmH2O unless otherwise stated.

[0256] The pressure in the patient interface is given the symbol Pm, and the treatment pressure, which represents the target value achieved by the interface pressure Pm at the current moment, is given the symbol Pt.

[0257] Respiratory Pressure Therapy (RPT): The application of air supply to the entrance of the airways at a treatment pressure that is typically positive relative to the atmosphere.

[0258] Ventilator: A mechanical device that provides pressure support to a patient and performs some or all of the work of breathing.

[0259] 4.8.1.1 Material Silicone or silicone elastomer: Synthetic rubber. In this specification, reference to silicone is a reference to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the line of products sold under this trademark) manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45, measured using ASTM D2240.

[0260] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0261] 4.8.1.2 Mechanical properties Elasticity: the ability of a material to absorb energy when elastically deformed and release energy when released

[0262] Elastic: Releases substantially all of the energy upon unloading. Examples include certain silicone and thermoplastic elastomers.

[0263] Hardness: The material's inherent resistance to deformation (as described by Young's modulus, indentation hardness scale, etc., measured on a standardized sample size). "Soft" materials may include silicone or thermoplastic elastomers (TPEs), and may easily deform under finger pressure, for example. "Hard" materials may include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed under finger pressure, for example.

[0264] 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 offer different resistance in different directions. The opposite of rigidity is flexibility.

[0265] Soft structure or part: A structure or part that changes shape (bends, etc.) in a relatively short time (such as 1 second) when supporting its own weight.

[0266] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such an application might be setting up and maintaining a patient interface in a sealed manner at a patient airway entrance under a pressure load of, for example, approximately 20-30 cmH2O.

[0267] As an example, an I-beam may have a different bending stiffness (resistance to bending load) in a first direction 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.

[0268] 4.8.2 Respiratory cycle Apnea: According to some definitions, apnea occurs when flow rate falls below a predetermined threshold for a period of time, e.g., 10 seconds. Obstructive apnea occurs when a partial obstruction of the airway prevents airflow despite the patient's efforts. Central apnea occurs when apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea occurs when reduced or absent respiratory effort coincides with an obstructed airway.

[0269] Respiratory rate: The patient's rate of spontaneous breathing, usually measured in breaths per minute.

[0270] Duty cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0271] Effort (breathing): The effort required by a spontaneous breather to breathe.

[0272] Expiratory portion of the respiratory cycle: the period from the start of the expiratory flow to the start of the inspiratory flow.

[0273] Flow limitation: Flow limitation is considered to be a condition in a patient's breathing where an increase in the patient's effort does not result in a corresponding increase in flow. When flow limitation occurs during the inspiratory portion of the respiratory cycle, it can be described as inspiratory flow limitation. When flow limitation occurs during the expiratory portion of the respiratory cycle, it can be described as expiratory flow limitation.

[0274] Flow-limited inspiratory waveform types: (i) Flattening: A rise followed by a relatively flat section, followed by a decline. (ii) M-shaped: It has two local peaks, one at the leading edge and one at the trailing edge, and has a relatively flat area between the two peaks. (iii) Chair shape: has a single local peak at the leading edge followed by a relatively flat portion. (iv) Reverse chair shape: A relatively flat section followed by a single local peak, which is at the trailing edge.

[0275] Hypopnea: By some definitions, hypopnea is considered a reduction in flow but not a cessation of flow. In one form, hypopnea may be said to have occurred when flow is reduced below a threshold rate for a period of time. Central hypopnea is said to have occurred when hypopnea is detected due to a reduction in respiratory effort. In one form in adults, any of the following may be considered hypopnea: (i) A 30% decrease in patient breathing for at least 10 seconds and an associated 4% desaturation; or (ii) A decrease in patient respiration (but less than 50%) for at least 10 seconds and associated desaturation or agitation of at least 3%.

[0276] Hyperventilation: An increase in airflow to a higher than normal level.

[0277] Inspiratory Portion of the Respiratory Cycle: The period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0278] Patency (Airway): The degree to which the airway is open, or the extent to which the airway is open. A patent airway is open. Airway patency may be quantified, for example, as a value of one (1) for an open state and a value of zero (0) for a closed (occluded) state.

[0279] Positive end-expiratory pressure (PEEP): The pressure in the lungs above atmosphere that exists at the end of expiration.

[0280] Peak flow (Q peak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0281] Respiratory flow, patient airflow rate, respiratory airflow rate (Qr): These terms may be understood to refer to the estimate of respiratory flow by an RPT device, as distinct from "true respiratory flow" or "true respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0282] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing when no extra effort is exerted. In principle, the inhalation volume Vi (volume of air inhaled) is equal to the exhalation volume Ve (volume of air exhaled), so a single tidal volume Vt can be defined as equal to either volume. In practice, the tidal volume Vt is estimated as some combination, e.g., average, of the inhalation volume Vi and the exhalation volume Ve.

[0283] Inspiration Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0284] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0285] (Total) Time (Ttot): The total time from the start of one inspiratory portion of the respiratory flow waveform to the start of the next inspiratory portion of the respiratory flow waveform.

[0286] Typical Recent Ventilation: The ventilation value around which recent ventilation values, Vent, over a given timescale tend to cluster, i.e., a measure of central tendency for recent ventilation values.

[0287] Upper Airway Obstruction (UAO): Includes both partial and complete upper airway obstruction. This can be associated with a state of flow limitation in which flow increases slightly or may even decrease as the pressure difference across the upper airway increases (Starling resistance behavior).

[0288] Ventilation (Airflow): A measure of the amount of gas exchanged by a patient's respiratory system. Measures of ventilation may include either or both of the inspiratory and expiratory flow rates per unit time. When expressed as volume per minute, this amount is often called "minute ventilation." Minute ventilation is sometimes given simply as volume and is understood as volume per minute.

[0289] 4.8.3 Respirator Adaptive servo-ventilator (ASV): A servo-ventilator with a variable, rather than fixed, target ventilation that can learn from some characteristics of the patient, such as the patient's breathing characteristics.

[0290] Backup Rate: A ventilator parameter that sets the minimum number of breaths (typically breaths per minute) that the ventilator will deliver to the patient if not triggered by spontaneous breathing effort.

[0291] Cycled: The end of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, at the end of the inspiratory portion of the breathing cycle, the ventilator is said to be cycled to stop delivering breaths.

[0292] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressures are applied within a breath to produce the desired interface pressure that the ventilator attempts to achieve at a given time.

[0293] End-Expiratory Pressure (EEP): The desired interface pressure that the ventilator attempts to achieve at the end of the expiratory portion of exhalation.

number

number

[0294] Inspiratory Positive Airway Pressure (IPAP): The maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0295] Pressure Support: A numerical value indicating the increase in ventilator pressure during inspiration over that during expiration, generally referring to the difference in pressure between peak and base pressure during inspiration (e.g., PS = IPAP - EPAP). In some situations, pressure support refers to the difference the ventilator attempts to achieve, rather than the difference it actually achieves.

[0296] Servo-ventilator: a ventilator that measures patient ventilation, has a target ventilation, and adjusts the level of pressure support to move patient ventilation toward the target ventilation.

[0297] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath in a spontaneously breathing patient. If the device does not detect a breath within a predetermined period, the device automatically begins delivering a breath.

[0298] Swing: A term equivalent to pressure support.

[0299] Triggered: When a ventilator delivers breathing air to a spontaneously breathing patient, it is said to do so by being triggered at the start of the respiratory portion of the breathing cycle by the patient's effort.

[0300] 4.8.4 Anatomy 4.8.4.1 Facial Anatomy Alar: outer wall or "wing" of each nostril (complex number: alar)

[0301] Outermost point on the ala: The outermost point on the nostril.

[0302] Alar curvature (or alar tip) point: The last point on the base line of the bend of each nostril, found in the crease formed when the nostril joins the cheek.

[0303] Pinna: the entire part of the ear that is visible externally.

[0304] (Nasal) skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0305] (Nasal) Cartilaginous Skeleton: The cartilaginous skeleton of the nose includes the nasal septum, lateral cartilages, major cartilages, and minor cartilages.

[0306] Columella: The strip of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0307] Columellar angle: The angle at which a line passing through the midpoint of the nostril and a line perpendicular to the Frankfort horizontal intersect with the subnasal point.

[0308] Frankfort horizontal plane: A line extending from the lowest point of the orbital rim to the left tragus point, which is the deepest point of the notch above the tragus of the external ear.

[0309] Glabella: Located on the soft tissue, the most prominent point in the forehead in the sagittal plane.

[0310] Lateral nasal cartilage: A roughly triangular cartilage plate whose upper edge is attached to the nasal bone and the frontal process of the maxilla, and whose lower edge is connected to the greater alar cartilage.

[0311] Lip, lower side (lower lip: labrale inferius):

[0312] Lip, upper side (upper lip: labrale superius):

[0313] Greater alar cartilage: A plate of cartilage located below the lateral nasal cartilage. The greater alar cartilage curves around the anterior part of the nostril. Its posterior end is connected to the frontal process of the maxilla via a tough fibrous membrane containing three or four alar cartilages.

[0314] Nostrils: Roughly oval openings that form the entrance to the nasal cavity. The singular form of nostrils is naris (nostril). The nostrils are separated by the nasal septum.

[0315] Naso-labial sulcus or naso-labial fold: a fold or groove of skin that separates the cheek from the upper lip and runs from either side of the nose to the corners of the mouth.

[0316] Nasolabial angle: the angle between the bridge of the nose and the upper lip, where it intersects with the subnasal point.

[0317] Inferior ear point: The lowest point where the pinna attaches to the facial skin.

[0318] The uppermost point of attachment of the auricle to the skin of the upper ear base and face.

[0319] Nasal tip: the most prominent point or tip of the nose, discernible in a lateral view with the rest of the head.

[0320] Philtrum: midline groove from the lower edge of the nasal septum to the apex of the lip in the upper lip region.

[0321] Most concave point: Located on the soft tissue at the most anterior midpoint of the jaw.

[0322] Nasal ridge (nose): The nasal ridge is a midline protrusion of the nose, extending from the selion to the apex.

[0323] Sagittal plane: A vertical plane from the front (anterior) to the back (posterior). The midsagittal plane is the sagittal plane that divides the body into left and right halves.

[0324] Therion: The most concave point located on the soft tissue and covering the frontonasal suture area.

[0325] Septal cartilage (nose): The nasal septum cartilage forms part of the nasal septum, separating the front of the nasal cavity.

[0326] Alar sinus: point on the lower edge of the base of the nasal alar where it joins the skin of the upper lip.

[0327] Subnasal point: Located in the soft tissue, the point in the midsagittal plane where the columella meets the upper lip.

[0328] The most concave point on the midline of the lower lip between the supraminal point, the midpoint of the lower lip, and the soft tissue pogonion.

[0329] 4.8.4.2 Skull anatomy Frontal bone: The frontal bone includes a large vertical portion, the scales frontalis, which corresponds to the area known as the forehead.

[0330] Mandible: The mandible forms the underside of the jaw. The mental prominence is the protuberance of the jaw and forms the jaw.

[0331] Maxilla: The maxilla forms the upper jaw and is located superior to the mandible and inferior to the orbit. The frontal process of the maxilla projects upward through the side of the nose and forms part of its lateral border.

[0332] The nasal bones are two small, oval bones that vary in size and shape in different individuals. They are positioned side by side in the mid and lower parts of the face and their junction forms the "bridge" of the nose.

[0333] Nasion: the area at the intersection of the frontal bone and the two nasal bones, the depression between the eyes and just above the bridge of the nose.

[0334] Occipital bone: The occipital bone is located at the lower back of the skull. The nasion contains an oval opening, the foramen magnum, through which the cranial cavity opens into the spinal canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0335] Orbit: the bony cavity within the skull that houses the eyeball.

[0336] Parietal bones: Parietal bones are bones that, when connected, form the top and sides of the skull.

[0337] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the areas of the face called the temples.

[0338] Cheekbones: The face includes two cheekbones that are located on the top and sides of the face and form the cheek ridges.

[0339] 4.8.4.3 Respiratory system structure Diaphragm: A piece of muscle that stretches across the base of the rib cage. It separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, it increases the volume of the thoracic cavity and draws air into the lungs.

[0340] The larynx, or voice box, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) with the trachea.

[0341] Lungs: Human respiratory system. The conducting region of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory region includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0342] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space in the center of the face above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On either side of the nasal cavity are three horizontal extensions called nasal conchae (singular "concha") or turbinates. At the front of the nasal cavity is the nose, which merges dorsally into the nasopharynx via the choanae.

[0343] Pharynx: part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is usually divided into three parts: the epipharynx (nasal part of the pharynx), the mesopharynx (oral part of the pharynx), and the hypopharynx.

[0344] 4.8.5 Patient Interface Anti-Asphyxiation Valve (AAV): A component or subassembly of a mask system that reduces the risk of the patient rebreathing excess carbon monoxide2 by venting to the atmosphere in a fail-safe manner.

[0345] Elbow: An elbow is a structure that guides the airflow axis to change 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 generally circular cross-section. In another form, the elbow can have an oval or rectangular cross-section. In certain forms, the elbow can be rotatable relative to the mating component, for example, approximately 360 degrees. In certain forms, the elbow can be detachable from the mating component, for example, via a snap connection. In certain forms, the elbow can be assembled to the mating component via a one-time snap during manufacturing, but cannot be removed by the patient.

[0346] Frame: Frame is taken to mean the mask structure that supports the tensile load between two or more points that connect the headgear. A mask frame can be a non-airtight load-bearing structure in the mask. However, some forms of mask frames may be airtight.

[0347] Headgear: Headgear refers to any form of positioning and stabilizing structure designed for the head. For example, headgear can include one or more sets of struts, ties, and stiffeners configured to position and hold a patient interface in the proper position on the patient's face for respiratory therapy. Some ties are formed from a flexible, resilient material, such as a laminated composite of foam and fabric.

[0348] Membrane: Membrane is taken to mean a typically thin-walled element, preferably substantially non-resistant to bending and resistant to stretching.

[0349] Plenum Chamber: Mask plenum chamber is taken to mean a part of a patient interface having walls that at least partially enclose a volume of space, the air in the volume being pressurized to exceed atmospheric pressure in use. The shell may form part of the wall of the mask plenum chamber.

[0350] Seal: When used as a noun ("seal"), it can refer to a structure, and when used as a verb ("to seal"), it can refer to an effect. Two elements can be constructed and / or arranged to achieve a "seal" or "seal" between them, but not require a separate "seal" element per se.

[0351] Shell: A shell is a relatively thin, curved structure that has bending, tensile, and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some embodiments, the shell may be faceted. In some embodiments, the shell may be airtight. In some embodiments, the shell may not be airtight.

[0352] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0353] Strut: A strut is considered a structural component designed to increase the compression resistance of another component in at least one direction.

[0354] Swivel (noun): A subassembly of components configured to rotate, preferably independently, about a common axis, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in connection with an air delivery conduit, the subassembly of components preferably includes a mating cylindrical conduit. In use, there may be little or no leakage of air flow from the swivel.

[0355] Tie (noun): A structure designed to resist tension.

[0356] Vent: (noun): A structure that allows air to flow from the interior of the mask or conduit to the ambient air, providing a clinically effective flush of exhaled air. For example, for clinically effective flushing, flow rates of about 10 liters / minute to about 100 liters / minute may be used depending on mask design and treatment pressure.

[0357] 4.8.6 Shape of structure Products of the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or impeller). The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be distinguished using labels to describe the orientation, location, function, or some other characteristic of the associated surfaces. For example, the structure may include one or more of a front surface, a back surface, an interior surface, and an exterior surface. In another example, the seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or interior) surface. In another example, the structure may include a first surface and a second surface.

[0358] To facilitate describing the shape of three-dimensional structures and surfaces, first consider a cross section across the surface of the structure at point p. Referring to Figures 3B-3F, examples of cross sections at point p on the surface and the resulting planar curves are shown. Figures 3B-3F also show the outward normal vector at p. The outward normal vector of p points away from the surface. In some examples, the surface is described from the perspective of a fictitious little person standing upright on the surface.

[0359] 4.8.6.1 Curvature in one dimension The curvature of a plane curve at p can be described by its sign (positive, negative, etc.) and magnitude (e.g., 1 / radius of the circle tangent to the curve at p).

[0360] Positive curvature: If the curve at p bends outward toward the normal, the curvature at that point is considered positive (when the hypothetical little person leaves point p, they have to walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such curves are commonly called concave curves.

[0361] Zero curvature: If the curve at p is a straight line, the curvature is considered to be zero (when the virtual little person leaves point p, they can walk horizontally, neither up nor down). See Figure 3D.

[0362] Negative curvature: If the curve at p moves away from the outer normal, the curvature in that direction at that point is considered negative (when a hypothetical little person leaves point p, they have to walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F) and Figure 3F (relatively large negative curvature compared to Figure 3E). Such curves are commonly called convex curves.

[0363] 4.8.6.2 Curvature of two-dimensional surfaces A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple perpendicular cross sections. The multiple cross sections may cut the surface in a plane containing the outward normal (the "normal plane"), and each cross section may be taken in a different direction. Each cross section results in a plane curve with a corresponding curvature. The different curvatures at the point may have the same sign or different signs. Each curvature at the point has a (e.g., relatively small) magnitude. The plane curves in Figures 3B-3F may be examples of such multiple cross sections at a particular point.

[0364] Principal curvatures and directions: The directions of the normal plane along which the curvature of a curve reaches its maximum and minimum values ​​are called the principal directions. In the example of Figures 3B-3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F, so Figures 3B and 3F are cross sections in the principal directions. The principal curvatures at p are the curvatures in the principal directions.

[0365] Surface region: A set of connected points on a surface. A set of points within a region may have similar properties, such as curvature or sign.

[0366] Saddle region: A region where, at each point, the principal curvatures have opposite signs, one positive and the other negative. (Depending on the direction the hypothetical person is facing, they may be walking uphill or downhill.)

[0367] Dome region: A region in which the principal curvatures at each point have the same sign, e.g., both positive (a "concave dome") or negative (a "convex dome").

[0368] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0369] Planar Region: The region of a surface where both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0370] Surface Edge: The boundary or limit of a surface or area.

[0371] Path: In certain forms of the present technology, a "path" is taken to mean a path in the mathematical, topological sense, e.g., a continuous space curve from f(0) to f(1) on a surface. In certain forms of the present technology, a "path" may be described as a route or course, e.g., including a set of points on a surface. (A hypothetical person's path is a place they walk on a surface, similar to a path in a garden.)

[0372] Path Length: In certain forms of the present technology, "path length" is taken to mean the distance along the surface from f(0) to f(1), i.e., the distance along a path on the surface. There may be more than one path between two points on the surface, and such paths may have different path lengths. (The path length of a hypothetical person is the distance they must walk on the surface along the path.)

[0373] Straight-line distance: Straight-line distance is the distance between two points on a surface, regardless of the surface. On a planar area, there is a distance on the surface edge that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there cannot be a path that has the same path length as the straight-line distance between two points. (To a hypothetical person, straight-line distance corresponds to the "as the crow flies" distance.)

[0374] 4.8.6.3 Space curve Space Curve: Unlike a plane curve, a space curve does not necessarily lie on a particular plane. A space curve can be closed, i.e., it has no endpoint. A space curve can be considered a one-dimensional piece of three-dimensional space. A fictional character walking on a strand of DNA helix walks along a space curve. A typical human left ear contains a left-handed helix (see Figure 3Q). A typical human right ear contains a right-handed helix (see Figure 3R). Figure 3S shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or impeller) can trace a space curve. In general, a space curve can be described by the curvature and twist at each point on the space curve. Twist is a measure of the way the curve emanates from the plane. Twist has a sign and a magnitude. The twist at a point on a space curve can be characterized by reference to the tangent, normal, and binormal vectors at that point.

[0375] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and amplitude from that point. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a hypothetical person were flying along the curve and fell off the car at a particular point, the direction of the tangent vector would be the direction the person would be traveling.

[0376] Unit normal vector: As our hypothetical person moves along the curve, this tangent vector itself changes. The unit vector that points in the same direction as the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0377] Binormal unit vector: The binormal unit vector is perpendicular to the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P) or the left-hand rule (see Figure 3O).

[0378] Oscillating plane: the plane containing the unit tangent vector and the unit principal normal vector. See Figures 3O and 3P.

[0379] Torsion of a Space Curve: The torsion of a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. It measures the degree of deviation of the curve from the tangent plane. A space curve that lies within a plane has zero torsion. If the space curve deviates from the tangent plane by a relatively small amount, the magnitude of torsion of the space curve is relatively small (e.g., a gently sloping spiral path). If the space curve deviates from the tangent plane by a relatively large amount, the magnitude of torsion of the space curve is relatively large (e.g., a steeply sloping spiral path). Referring to Figure 3S, the amount of torsion near the top coil of the spiral in Figure 3S is greater than the amount of torsion near the bottom coil of the spiral in Figure 3S because T2>T1.

[0380] Referring to the right-hand rule in Figure 3P, a space curve that bends toward the right-hand binormal can be considered to have a positive right-hand twist (e.g., a right-hand spiral as shown in Figure 3S). A space curve that bends away from the right-hand binormal can be considered to have a negative right-hand twist (e.g., a left-hand spiral).

[0381] Similarly, with reference to the left-hand rule (see Figure 3O), a space curve oriented in a left-handed binormal direction can be considered as having a positive left-handed twist (e.g., a left-handed spiral). Thus, a positive left-handed direction corresponds to a negative right-handed direction. See Figure 3T.

[0382] 4.8.6.4 holes A surface may have one-dimensional holes (e.g., holes bounded by a planar or spatial curve). In the case of a thin structure (e.g., a membrane) that contains holes, the structure may be described as having one-dimensional holes. See, for example, how the one-dimensional holes in the surface of the structure shown in Figure 3I are bounded by a planar curve.

[0383] A 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 tire's inner surface. In another example, a bladder with a cavity for air or gel may have a two-dimensional hole. See, for example, the cushion in FIG. 3L and the exemplary cross-section of FIG. 3L in FIGS. 3M and 3N, where the inner surface bounding the two-dimensional hole is shown. 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. See also the two-dimensional hole through the structure shown in FIG. 3K and bounded by a surface as shown.

[0384] 4.9 Other Notes A portion of the disclosure of this patent document contains material that is entitled to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of this patent document or this patent disclosure, as it appears in the Patent and Trademark Office patent file or records, but reserves all copyright rights therefor for all other purposes.

[0385] Unless the context clearly dictates otherwise, when a range of values ​​is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limits of that range, and any other stated or intervening value within that range, is encompassed within the technology. The upper and lower limits of these intervening ranges, which may be independently included in the intervening ranges, are also encompassed within the technology, subject to any explicitly excluded limit in the stated range. When the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also encompassed within the technology.

[0386] Furthermore, when one or more values ​​are described herein as being implemented as part of the present technology, unless otherwise specified, it is understood that such values ​​may be approximated and that such values ​​may be utilized to any appropriate significant digit to the extent that a practical technical implementation may permit or require it.

[0387] 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. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present technology, a limited number of exemplary methods and materials are described herein.

[0388] When a particular material is identified as being used to deploy a deployment element, obvious alternative materials having similar properties may be substituted. Furthermore, unless specified to the contrary, any and all deployment elements described herein are understood to be manufacturable and may be manufactured together or separately.

[0389] It should be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0390] All publications mentioned herein are incorporated by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein should be construed as an admission that the present technology is not entitled to antedate such publication by virtue of prior invention. Further, the publication dates provided may be different from the actual publication dates, which may need to be independently confirmed.

[0391] The terms "comprise" and "comprising" should be construed to refer to elements, arrangements, or steps in a non-exclusive manner, indicating that a referenced element, arrangement, or step can be present or combined with other elements, arrangements, or steps that are not explicitly referenced.

[0392] The subject headings used in the detailed description are included solely for the reader's ease of reference and should not be used to limit the subject matter found throughout this disclosure or the claims. The subject headings should not be used in construing the scope of the claims or the limitations of the claims.

[0393] Although the technology herein has been described with reference to particular 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 imply specific details that are not required to practice the technology. For example, the terms "first" and "second" may be used, but unless otherwise specified, they are not intended to indicate an order and may be utilized to distinguish between different elements. Furthermore, while process steps in a methodology may be described or illustrated in a sequence, such ordering is not required. Those skilled in the art will recognize that such ordering may be modified and / or aspects may occur simultaneously or synchronously.

[0394] It is therefore to be understood that numerous modifications may be made to the illustrative examples and other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0395] 1000 patients 1100 Bedmate 3000 Patient Interface 3100 Seal forming structure 3200 Plenum Chamber 3204 Plenum Chamber Connector 3300 Positioning and Stabilizing Structures 3310 Strap 3320 Strap engagement part 3322 Strap engagement hole 3350 Gas delivery pipe 3351 Pipe edge 3352 variable length portion 3354 bellows-shaped part 3356 Fixed length part 3358 End 3359 Rim 3360 Fluid Connection Opening 3363 Sleeve 3400 Ventilation section 3600 connection port 3610 Elbow 3650 Woven Sleeve 3652 Sleeve part 3654 Sleeve part 3660 functional area 3666 Wall 3668 Opening 3669 Perimeter 3670 1st material 3672 2nd material 3674 First (patient-contacting) side of sleeve 3676 Second (non-patient contact) side of sleeve 3678 seams 3680 Connection port opening 3700 Forehead Support 3800 End Cap 3802 Side wall 3804 End flange 3806 Opening 3808 End 3810 Inner surface 3812 Adhesive recess 3813 Adhesives 3814 Axial recess 3816 Visual Indicators 3818 tabs 3850 Discrete Polymer Layers 3852 Silicone layer 3854 double-sided tape 3860 overmolded end section 3862 side wall 3864 End flange 3900 Edge reinforcement structure 3902 Edge reinforcement structure 3920 Seam tape 4000 RPT devices 4170 Air Circuit 5000 humidifier L Opening length B. Base length of connecting means CB gap CL sleeve center line C Circumferential direction D distance

Claims

1. a positioning and stabilizing 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 has a pressure of at least 6 cmH above ambient pressure throughout the patient's respiratory cycle in use. ２ O constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway to sealingly deliver a flow of air at an elevated therapeutic pressure to at least the patient's nostrils; the positioning and stabilizing structure includes a gas delivery tube for receiving the air flow from a connection port on the top of the patient's head and delivering the air flow through the seal-forming structure to an entrance of the patient's airway; the gas delivery tube is constructed and arranged to contact, in use, at least a region of the patient's head above the superior ear base point; the positioning and stabilizing structure further includes an elongated fabric sleeve disposed about the gas delivery tube and positioned to contact the patient's face in use; The positioning and stabilizing structure, wherein the textile sleeve comprises a single piece knit and / or woven structure that is resilient and flexible in both the circumferential and axial directions.

2. the textile sleeve includes a body structure and one or more functional regions knitted and / or woven into the body structure; 10. The positioning and stabilizing structure of claim 1, wherein the functional region has one or more fabric characteristics that are different from the fabric characteristics of the body structure.

3. 3. The positioning and stabilizing structure of claim 2, wherein at least one of the functional areas is a transparent or translucent area through which at least a portion of the gas delivery tube is visible.

4. 3. The positioning and stabilizing structure of claim 2, wherein the one or more fabric characteristics include one or more of knit density, weave density, number of loops in a given knit pattern, knit or weave pattern, yarn density, yarn type, and fiber cross-section.

5. 10. The positioning and stabilizing structure of claim 1, wherein at least a portion of the fabric sleeve is coated or impregnated with at least one material that imparts functional and / or aesthetic properties.

6. 6. The positioning and stabilizing structure of claim 5, wherein the at least one material is one or more of a phosphorescent material, a fluorescent material, or an antimicrobial composition.

7. 10. The positioning and stabilizing structure of claim 1, wherein the fabric sleeve has greater flexibility in the axial direction than in the circumferential direction.

8. the gas delivery tube includes a strap engaging portion; the fabric sleeve has a first opening; 10. The positioning and stabilizing structure of claim 1, wherein through said first opening, at least a portion of said strap-engaging portion is available for engagement with a strap.

9. 10. The positioning and stabilizing structure of claim 8, wherein the strap engaging portion comprises a tab.

10. the positioning and stabilizing structure includes a second strap-engaging portion; the fabric sleeve has a second opening; 9. The positioning and stabilizing structure of claim 8, wherein through said second opening, said second strap-engaging portion is available for engagement with a strap.

11. the positioning and stabilizing structure includes a second gas delivery conduit; 2. The positioning and stabilizing structure of claim 1, wherein the woven sleeve extends across both the gas delivery tube and the second gas delivery tube.

12. 2. The positioning and stabilizing structure of claim 1, wherein the fabric sleeve includes a connection port opening configured to allow an air circuit or elbow to be connected to the connection port in use.

13. the first opening has a generally oval, elliptical or stadium shape; and / or 10. The positioning and stabilizing structure of claim 8, wherein the second opening, if present, has a generally elliptical, oval, or stadium shape.

14. 11. The positioning and stabilizing structure of claim 10, wherein at least one of the first opening, the second opening, and the connection port opening includes an edge reinforcement structure to reduce or eliminate fabric abrasion.

15. 15. The positioning and stabilizing structure of claim 14, wherein the edge reinforcement structure comprises one or more of seam tape, stitching, thermal bonds, thickened areas, and end caps.

16. 2. The positioning and stabilizing structure of claim 1, wherein the elongated woven sleeve is secured to the gas delivery tube at a location proximal to the end of the gas delivery tube adjacent the seal-forming structure.

17. 17. The positioning and stabilizing structure of claim 16, wherein the elongated woven sleeve is secured to the at least one gas delivery tube by an adhesive.

18. 17. The positioning and stabilizing structure of claim 16, wherein the elongated woven sleeve is secured to the at least one gas delivery tube by an end cap.

19. 20. The positioning and stabilizing structure of claim 18, wherein the end cap extends from an outer surface of the elongated woven sleeve, beyond an end of the elongated woven sleeve, and beyond at least a portion of a rim of the gas delivery tube.

20. 20. The positioning and stabilizing structure of claim 18, wherein the end cap includes an annular sidewall and an end flange extending radially inward from the annular sidewall.

21. 20. The positioning and stabilizing structure of claim 18, wherein the end cap includes at least one visual indicator that indicates one or more of the alignment of the gas delivery tube connection to the seal-forming structure and the size of the positioning and stabilizing structure.

22. 10. The positioning and stabilizing structure of claim 1, wherein the at least one fabric sleeve is secured to the at least one gas delivery tube via a localized high friction interface.

23. 10. The positioning and stabilizing structure of claim 1, wherein at least one of the woven sleeves is secured to at least one of the gas delivery tubes by an overmolded end portion.

24. 1. A patient interface comprising: At least 6 cmH above ambient pressure ２ a plenum chamber pressurizable to an elevated therapeutic pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at said therapeutic pressure for breathing by a patient; When in use, the pressure must be at least 6 cmH above ambient pressure throughout the patient's breathing cycle. ２ a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway to hermetically deliver an airflow at an elevated therapeutic pressure, the seal-forming structure having an aperture for delivering said airflow at therapeutic pressure to an entrance to at least one of the patient's nostrils, the seal-forming structure constructed and arranged to maintain said therapeutic pressure within said plenum chamber throughout the patient's respiratory cycle in use; A positioning and stabilising structure according to any one of claims 1 to 23; A patient interface comprising:

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