Seal-forming structure for patient interface including textile seal member

Abstract

To provide a novel patient interface.SOLUTION: A patient interface may have a frame and a seal-forming structure. The frame may at least partially form a plenum chamber pressurizable to a therapeutic pressure. The seal-forming structure may be constructed and arranged to form a seal on a region of a patient's face surrounding an entrance to the patient's airways, the seal-forming structure having a hole therein so that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle in use. The seal-forming structure may comprise a textile seal member adapted to sealingly engage the patient's face in use.SELECTED DRAWING: Figure 7-1

Description

[Technical Field]

[0001] 1 Cross-reference to related applications This application claims the benefit of Australian Provisional Patent Application No. 201902284, filed June 28, 2019, each of which is incorporated by reference in its entirety herein.

[0002] 2. Technical Background 2.1 Technology field 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]

[0003] 2.2 Description of Related Art 2.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways.

[0004] These airways contain a series of branching tubes 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 from the air to enter the venous blood and carbon dioxide to leave. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute 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, which is called the respiratory region. See: "Respiratory Physiology," by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0005] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

[0006] Examples of respiratory diseases 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 diseases.

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes of upper airway closure or obstruction during sleep. This is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the tongue region, soft palate, and posterior oropharyngeal wall during sleep. This condition causes affected individuals to experience breathing pauses typically lasting 30 to 120 seconds, sometimes 200 to 300 times per night. This can result in excessive daytime sleepiness, which can contribute to cardiovascular disease and brain damage. This condition is common, particularly among middle-aged, overweight men, but patients often experience no symptoms. See U.S. Patent No. 4,944,310 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory regulator, characterized by 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).

[0009] Respiratory failure is a general term for respiratory disorders that refers to the inability of the lungs to take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following conditions:

[0010] Patients with respiratory failure (a type of respiratory insufficiency) may experience unusual shortness of breath during exercise.

[0011] 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.

[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics, including increased resistance to air movement, prolonged expiratory phase of breathing, and a decrease in normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0013] 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 the inability to walk, wheelchair confinement, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be categorized as rapidly progressive or slowly progressive: (i) rapidly progressive disorders, characterized by muscle impairment that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders, characterized by muscle impairment that worsens over years and results in only a modest reduction in 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.

[0014] 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 lead to 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.

[0015] A range of treatments are available to treat or ameliorate these conditions. In addition, otherwise healthy individuals can benefit from preventative treatments for respiratory disease. However, these suffer from several deficiencies.

[0016] 2.2.2 Treatment A variety of therapies are used to treat one or more of the above respiratory disorders, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV).

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

[0018] Noninvasive ventilation (NIV) provides ventilatory support to a patient through the upper airway to assist the patient in breathing and / or maintain adequate oxygen levels in the body by performing some or all of the respiratory functions. Ventilatory support is provided through 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] 2.2.3 Treatment System These treatments may be provided by therapeutic systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor a disease without treating it.

[0021] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0022] Another form of treatment system is a mandibular repositioning device.

[0023] 2.2.3.1 Patient Interface A patient interface may be used to provide a wearer with an interface to a respiratory appliance, for example, by providing airflow to the airway entrance. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy being applied, the patient interface may form a seal with, for example, an area of ​​the patient's face, thereby facilitating gas delivery at a pressure sufficient to disperse with atmospheric pressure for therapy implementation (e.g., at a positive pressure of about 10 cmH2O relative to atmospheric pressure). In other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of a gas supply to the airways at a positive pressure of about 10 cmH2O.

[0024] 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 and not maintain internal air at pressures higher than ambient.

[0025] Certain masks may be clinically unsuitable for this technology (for example, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0026] In certain masks, the patient must insert part of the mask structure into their mouth and create and maintain a seal via their lips, which may be uncomfortable or impractical in this technology.

[0027] Certain masks may be impractical for use while sleeping (eg, when sleeping on your side in bed with your head resting on a pillow).

[0028] There are multiple challenges in designing a patient interface. 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 chin or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory treatment period.

[0029] These challenges can lead to one or more of the following: some masks can be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially if worn for extended periods or if the patient is unfamiliar with the system. If the wrong size mask is used, this can lead to reduced compliance, reduced comfort, and poor patient outcomes. While masks specifically designed for aviators, personal protective equipment (e.g., filter masks), SCUBA masks, or anesthesia administration masks 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 must be worn while sleeping.

[0030] CPAP therapy is highly effective in treating certain respiratory conditions when patients comply with the therapy. However, if the mask is uncomfortable or difficult to use, patients may not comply. Patients are often encouraged to clean their masks regularly, but 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.

[0031] 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.

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

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

[0034] Patient interfaces can be characterized in part according to the design intent of where the seal-forming structure engages with the face during use. In one form of patient interface, the seal-forming structure can 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 can include a single element that surrounds both nostrils during use. Such a single element can be designed, for example, to rest on the upper lip region and nose bridge region of the face. In one form of patient interface, the seal-forming structure can include an element that surrounds the mouth region during 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 can include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces can be known by various names depending on their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0035] A seal-forming structure that may be effective in one area of ​​a patient's face may be inappropriate in another area due to, for example, different shapes, structures, variability, and sensitive areas of the patient's face. For example, the seal of swim goggles that rests on the patient's forehead may be inappropriate for use on the patient's nose.

[0036] A particular seal-forming structure may 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 there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-manufactured patient interface, one or both may need to be adapted to form a seal.

[0037] One type of seal-forming structure extends around the periphery of the patient interface and is 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, if the fit is improper, a gap will form between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0038] Another type of seal-forming structure uses a thin flap seal positioned around the 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 fit between the face and the mask can require additional force to achieve a seal or the mask can leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming portion can fold or buckle during use, causing leakage.

[0039] Other types of seal-forming structures may include friction-fit elements that are inserted into the nostrils, for example, but some patients find these seal-forming parts uncomfortable.

[0040] Another form of seal-forming structure may use adhesives to achieve a seal, as some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0041] A range of patient interface seal forming structures are disclosed in the following patent applications (assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

[0042] One form of nasal pillow is found in the Adam line 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.

[0043] 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. Embodiments 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).

[0044] 2.2.3.1.2 Positioning and stabilization The seal-forming structures of patient interfaces used in positive air pressure therapy are subjected to corresponding forces of air pressure that disrupt the seal, and therefore a variety of techniques are used to position the seal-forming structures and maintain a seal against the appropriate portion of the face.

[0045] One technique involves the use of adhesives, see, for example, U.S. Patent Application Publication No. US2010 / 0000534, but adhesives can be uncomfortable.

[0046] Another technique involves the use of one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following problems: poor fit, bulky, uncomfortable, and cumbersome.

[0047] 2.2.3.2 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 above-mentioned therapies, for example, by actuating the device to generate a delivery flow of air to an interface with the airway. This air flow can be pressurized. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0048] 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 cannot be met by more common air pressure generators (e.g., the reliability, size, and weight requirements of medical equipment). In addition, even devices designed for medical treatment may suffer from deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0049] One example of a special requirement for a particular RPT device is acoustic noise.

[0050] Table of noise output levels of conventional RPT devices (measured on one sample only at 10cmH2O in CPAP mode using the test method specified in ISO3744). [Table 1]

[0051] One 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 respiratory support for patients for a range of conditions, including, but not limited to, NMD, OHS, and COPD.

[0052] The ResMed Elis Accent-Aiguée® 150 ventilator and ResMed VSIII® ventilators can provide invasive and non-invasive dependent respiratory support suitable for adult or pediatric patients for the treatment of multiple conditions. These ventilators offer volumetric and pressure ventilation modes using single or dual limb circuits. RPT devices typically include a pressure generator (e.g., 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.

[0053] 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 minor changes in one or more parameters.

[0054] 2.2.3.3 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 comfort of the patient's airway. Additionally, in cooler climates, the application of warm air to the facial area surrounding the patient interface generally provides more comfort than cool air.

[0055] A range of artificial humidification devices and systems are known, but do not meet the special requirements of medical humidifiers.

[0056] Medical humidifiers are typically used when a patient is sleeping or resting (e.g., in a hospital) to increase the humidity and / or temperature of an air stream relative to the ambient air when needed. Bedside medical humidifiers may be compact. Medical humidifiers may be configured to only humidify and / or heat the air stream delivered to the patient, not the patient's surroundings. For example, while room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed into the patient's body, these systems also humidify and / or heat the entire room, which may be uncomfortable for occupants. Additionally, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0057] Although many medical humidifiers are known, such medical humidifiers may suffer from one or more deficiencies, such that some provide inadequate humidification or are difficult or inconvenient for the patient to use.

[0058] 2.2.3.4 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant" (e.g., whether the patient adheres to one or more "compliance rules" with their RPT device). An example of a compliance rule for CPAP therapy may require a patient to use the RPT device for at least four hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's treatment with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. Once the healthcare provider determines that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

[0059] There may be other aspects of patient care that benefit from communication of treatment data to third parties or external systems.

[0060] Existing processes for communicating and managing such data can be costly, time consuming, and / or error prone.

[0061] 2.2.3.5 Mandibular repositioning A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one treatment option for sleep apnea and snoring. It is an adjustable oral appliance available from dentists or other suppliers that holds the mandible (lower jaw) in an anterior position during sleep. MRDs are removable devices that are inserted into the mouth before a patient goes to sleep and removed afterward. As such, MRDs are not designed for full-time wear. MRDs can be custom-made or manufactured in standard forms and include bite impression sections designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension on the pharyngeal walls, reducing airway collapse and palatal vibration.

[0062] In certain embodiments, the mandibular advancement device may include an upper splint intended to engage or mate with teeth on the upper jaw or maxilla, and a lower splint intended to engage or mate with teeth on the upper jaw or mandible. The upper and lower splints are laterally connected to each other via a pair of connecting rods that are fixed symmetrically on the upper and lower splints.

[0063] In such a design, the length of the connecting rod is selected so that the mandible is held in a forward position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the level of mandibular protrusion. The dentist can determine the level of protrusion required for the mandible, and the length of the connecting rod is determined accordingly.

[0064] Some MRDs are configured to push the mandible forward relative to the maxilla, while others, such as the ResMed Narval CC® MRD, are designed to hold the mandible in a forward position. The devices also reduce or minimize dental and temporomandibular joint (TMJ) side effects. As such, the devices are configured to minimize or prevent any movement of one or more teeth.

[0065] 2.2.3.6 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 vents may include orifices 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 sleep for the patient 1000 and 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. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

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

[0069] (*Measured using only one sample at 10cmH2O in CPAP mode using the test method specified in ISO3744)

[0070] The sound pressure values ​​of various objects are listed below [Table 3]

[0071] 2.2.4 Screening, diagnostic and monitoring systems Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, but it typically requires specialized clinical staff for system application. PSG typically involves placing 15–20 contact sensors on the human body to record various body signals (e.g., electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), and electromyography (EMG)). PSG for sleep-disordered breathing requires patients to be observed for two nights in a specialized hospital: the first night for pure diagnosis and the second night for clinician-assisted titration of treatment parameters. Therefore, PSG is expensive and inconvenient. Screening, diagnosing, and monitoring sleep-disordered breathing is particularly unsuitable for home use.

[0072] In general, screening and diagnosis involve identifying disease through signs and symptoms. Screening typically produces a true / false result indicating whether a patient's SDB warrants further investigation, while diagnosis often produces clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the progression of disease can continue indefinitely. While some screening / diagnostic systems are adapted solely for screening / diagnosis, some can also be used for monitoring.

[0073] A clinical expert may adequately screen, diagnose, or monitor a patient based on visual observation of the PSG signal. However, there are situations where a clinical expert is unavailable or cannot be paid for. Different clinical experts may have different opinions about a patient's condition. Furthermore, some clinical experts may apply different criteria at different times. [Prior art documents] [Patent documents]

[0074] [Patent Document 1] U.S. Patent No. 4,944,310 [Patent Document 2] U.S. Patent No. 6,532,959 Summary of the Invention [Problem to be solved by the invention]

[0075] 3. Brief description of the technology The present technology relates to the provision of medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory diseases, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0076] A first aspect of the present technology relates to devices used in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disease.

[0077] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0078] An aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.

[0079] One form of the present technology includes a patient interface, the patient interface comprising: a frame at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air 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 airways, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; the seal-forming structure includes a compliant section on the frame, a stiffening element within the compliant section, and a seal member adapted for sealing engagement with the patient's face in use; The frame and seal member are constructed at least in part from a woven material, and the compliant section is constructed from a resilient material different from the woven material.

[0080] One form of the present technology includes a patient interface, the patient interface comprising: a frame, the frame at least partially formed from a fabric, partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure; a seal-forming structure constructed and arranged to form a seal against an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle, said seal-forming structure including a fabric sealing member adapted for sealing engagement with the patient's face in use; a positioning and stabilizing structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure being formed at least in part from a textile; the frame includes a plenum chamber portion, the seal-forming structure is disposed on a rearwardly facing surface of the plenum chamber portion, the plenum chamber portion extending over the aperture in the seal-forming structure; the frame includes a side portion extending beyond the seal-forming structure in a direction away from the aperture in the seal-forming structure; The lateral sections connect the frame to the positioning and stabilizing structure via a one-piece woven structure.

[0081] One form of the present technology includes a patient interface, the patient interface comprising: a frame at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air 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 airways, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; The seal-forming structure comprises: a compliant portion provided on the frame; one or more stiffening elements disposed within the compliant section, the one or more stiffening elements being constructed from a different material than the compliant section; a fabric seal member provided on the compliant section and adapted for sealing engagement with the patient's face in use.

[0082] One form of the present technology includes a patient interface, the patient interface comprising: a frame at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air 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 airways, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; the seal-forming structure includes a compliant portion provided on the frame and a fabric sealing member that surrounds an entrance to the patient's airway and is adapted for sealing engagement with the patient's face in use; The frame and seal member are constructed at least in part from a woven material, and the compliant section is constructed from a resilient material different from the woven material.

[0083] One form of the present technology includes a patient interface, the patient interface comprising: a frame at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air 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 airways, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; The seal-forming structure comprises: a compliant section disposed on the frame, the width of the compliant section being greater than the thickness of the compliant section; a fabric seal member provided on the compliant section and adapted for sealing engagement with the patient's face in use, the fabric seal member having a cantilevered configuration relative to the compliant section, the frame extending generally parallel to the fabric seal member;

[0084] One form of the present technology includes a patient interface, the patient interface comprising: a frame at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air 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 airways, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use; The seal-forming structure comprises: a compliant portion provided on the frame; one or more stiffening elements disposed within the compliant section, the one or more stiffening elements being constructed from a different material than the compliant section; a fabric seal member provided on the compliant portion and adapted for sealing engagement with the patient's face in use, the fabric seal member including an overhang portion extending from the compliant portion.

[0085] In examples, an overhanging portion of the fabric seal member may extend radially inward from the compliant portion.

[0086] One form of the present technology includes a patient interface, the patient interface comprising: a frame at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the frame being at least partially formed from a woven material; 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, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle; the seal-forming structure includes a fabric sealing member adapted for sealing engagement with the patient's face in use; the fabric seal member includes at least one seal-enhancing feature on a rearward-facing surface of the fabric seal member; The frame extends generally parallel to the fabric seal member along the length of the seal-forming structure.

[0087] In an embodiment of the foregoing aspect: (a) the frame is flexible; (b) the frame is constructed of a flexible material; (c) the frame is constructed entirely of a textile material; (d) the frame includes a plenum chamber portion, and the seal-forming structure is disposed on a rearwardly facing surface of the plenum chamber portion, the plenum chamber portion extending over an aperture in the seal-forming structure through which airflow at therapeutic pressure is delivered to at least an entrance to the patient's nares; (e) the frame includes lateral portions extending beyond the seal-forming structure in a direction away from the aperture in the seal-forming structure; and (f) the stiffening element is exposed to the atmosphere.

[0088] In an embodiment of the foregoing aspect: (a) the seal-forming structure includes a woven seal member adapted for sealing engagement with the patient's face in use; (b) the woven seal member surrounds an entrance to the patient's airway and is adapted for sealing engagement with the patient's face in use; (c) the width of the woven seal member varies along its length; (d) the woven seal member is air impermeable; the woven seal member is air permeable; (e) the seal-forming structure includes a compliant section mounted to the frame, the woven seal member being mounted to the compliant section and adapted for sealing engagement with the patient's face in use; (f) the width of the compliant section is greater than the thickness of the compliant section; and (g) the thickness of the compliant section varies along different portions of the seal-forming structure. (h) the width of the compliant section varies between different regions of the seal-forming structure; the compliant section is constructed of a foam material; (i) the compliant section has a structure that provides the compliant characteristics; (j) the woven seal member includes an overhanging portion extending from the compliant section; (k) the overhanging portion of the woven seal member overhangs the compliant section in a radially inward direction; (l) the overhanging portion of the woven seal member provides a pressure-assisted seal; (m) the one or more stiffening elements are exposed to the atmosphere; and (n) the one or more stiffening elements limit compression of the compliant section and maintain a thickness between the frame and the woven seal member.

[0089] In embodiments of the foregoing aspects: (a) the woven seal member includes at least one seal-enhancing feature on the rear-facing surface of the woven seal member; (b) the seal-enhancing feature increases the adhesiveness of the woven seal member; (c) the seal-enhancing feature includes a layer of seal-enhancing material; (d) the seal-enhancing feature includes discontinuously disposed seal-enhancing material; (e) the seal-enhancing material is one or more of polyurethane and silicone; (f) the seal-enhancing feature is disposed in selected region(s) along the length of the woven seal member; (g) the seal-enhancing feature is more extensive in the selected region than in one or more other regions; (h) the seal-enhancing feature is more extensive in an area that contacts the nose or nasal bridge region or over the nasal bridge region of the patient's face in use; (i) the seal-enhancing feature is disposed along the entire length of the woven fabric.

[0090] In an embodiment of the above aspect: (a) the patient interface includes a positioning and stabilizing structure, the positioning and stabilizing structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head; (b) the positioning and stabilizing structure is provided on a frame; (c) the positioning and stabilizing structure is sewn, bonded, or integrally formed with the frame; and (d) at least a portion of the positioning and stabilizing structure is elastic.

[0091] In an embodiment of the above aspect: (a) the patient interface includes at least one conduit configured to deliver a flow of air at a therapeutic pressure to a plenum chamber for breathing by the patient; (b) the conduits are provided at intermediate and lower positions on the frame; (c) the first conduit and the second conduit are routed along the lateral sides of the patient's head between corresponding ones of the patient's eyes and ears; and (d) the first conduit and the second conduit form part of a positioning and stabilizing structure.

[0092] In an embodiment of the above aspect: (a) the patient interface includes a vent structure for allowing continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the vent structure being sized and shaped to maintain therapeutic pressure within the plenum chamber in use; (b) the vent structure includes a vent hole in the flexible material of the frame; (c) the vent structure includes a vent hole in a rigid insert provided in the frame; (d) the vent structure includes an air permeable portion of the frame; and (e) the vent structure is provided in a connection port provided in the frame.

[0093] In another embodiment of the above aspect: (a) the sealing member contacts the bridge of the patient's nose and the patient's chin in use; (b) the sealing member is configured to be positioned near the patient's nasal tip and adjacent the patient's lateral and / or greater alar cartilages in use; (c) the uppermost point of the sealing member is configured to be substantially aligned with the patient's Frankfurt horizontal plane in use; and (d) the sealing member forms a perimeter, and the patient's nasolabial folds are configured to be positioned within the perimeter in use.

[0094] One form of the present technology includes a patient interface, the patient interface comprising: a frame at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle, in use.

[0095] One form of the present technology includes a patient interface, the patient interface comprising: a frame partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airway; and a positioning and stabilizing structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0096] One form of the present technology includes a seal-forming structure comprising: a compliant portion provided on the frame; one or more stiffening elements disposed within the compliant section, the one or more stiffening elements being constructed of a different material than the compliant section; a fabric seal member provided on the compliant portion and adapted for sealing engagement with the patient's face in use, the fabric seal member including an overhang portion extending from the compliant portion.

[0097] One form of the present technology includes a seal-forming structure comprising: a compliant portion provided on the frame; one or more stiffening elements disposed within the compliant section, the one or more stiffening elements being constructed from a different material than the compliant section; a fabric seal member provided on the compliant section and adapted for sealing engagement with the patient's face in use.

[0098] One form of the present technology includes a seal-forming structure comprising: a compliant section disposed on the frame, the width of the compliant section being greater than the thickness of the compliant section; a fabric seal member provided on the compliant section and adapted for sealing engagement with the patient's face in use, the fabric seal member having a cantilevered configuration relative to the compliant section, the frame extending generally parallel to the fabric seal member;

[0099] One form of the present technology includes a patient interface, the patient interface comprising: A frame according to any of the preceding embodiments or examples thereof, the frame at least partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and configured to receive airflow at the therapeutic pressure for breathing by a patient; a seal-forming structure according to any of the preceding aspects or examples thereof, 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, the seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle in use; a positioning and stabilizing structure according to any of the preceding aspects or examples thereof, the positioning and stabilizing structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie, the tie constructed and arranged such that, in use, at least a portion of the tie rests on a region of the patient's head above a superior auricular point of the patient's head; a venting structure that allows continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the venting structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use; The patient interface is configured to allow the patient to breathe from the atmosphere through their oral cavity in the absence of pressurized air flow through the plenum chamber inlet port, or alternatively, the patient interface is configured to leave the patient's oral cavity exposed.

[0100] One form of the present technology includes a patient interface, the patient interface comprising: a frame, the frame at least partially formed from a fabric, partially defining a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure; a seal-forming structure constructed and arranged to form a seal against an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle, said seal-forming structure including a fabric sealing member adapted for sealing engagement with the patient's face in use; a positioning and stabilizing structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure being formed at least in part from a textile, the positioning and stabilizing structure including an upper strap configured to pass between the patient's eyes and ears; at least one conduit configured to deliver a flow of air at a therapeutic pressure to the plenum chamber for breathing by the patient; the frame, the seal-forming structure, the positioning and stabilizing structure, and the at least one conduit are connected together via a one-piece woven structure; At least one conduit is superimposed on the upper strap.

[0101] In an embodiment of the foregoing aspect: (a) the seal-forming structure is configured to form a seal around only the patient's nares or around the patient's nares and the patient's mouth; (b) the positioning and stabilizing structure forms at least a portion of the at least one conduit; (c) the at least one conduit includes a first conduit and a second conduit, each of which is routed along a lateral side of the patient's head between a corresponding one of the patient's eyes and ears; (d) the at least one conduit is translationally fixed relative to the positioning and stabilizing structure; (e) the at least one conduit includes at least one nasal opening configured to seal around the patient's nostril margins; and / or (f) the at least one conduit further includes an oral opening configured to deliver pressurized air to the patient's mouth.

[0102] In an embodiment of the above aspect: (a) a stiffening portion at least partially disposed on a forward-facing surface of the frame and connected to the frame via a one-piece structure; (b) the stiffening portion is constructed from a different material than the frame; (c) an upper portion extending along an upper strap of the positioning and stabilizing structure and a lower portion extending along a lower strap of the positioning and stabilizing structure; (d) the upper and lower portions are connected to the positioning and stabilizing structure via a one-piece structure; (e) the upper and lower portions extend laterally further than the at least one conduit; (f) the upper and lower portions extend substantially the same distance from the patient's head; and / or (g) the stiffening portion is constructed from foam.

[0103] 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.

[0104] One aspect of the present technology is a method for manufacturing a device.

[0105] 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.

[0106] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., around the home).

[0107] An aspect of one form of the present technology is a patient interface that can be cleaned at 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 at the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0108] The described methods, systems, devices, and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor in a special purpose computer, a respiratory monitor, and / or a respiratory treatment device). Further, the described methods, systems, devices, and apparatus enable advancements in the art of automated management, monitoring, and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0109] Of course, some of the above aspects may form sub-aspects of the present technology, and various sub-aspects and / or aspects may be combined in various ways to form further aspects or sub-aspects of the present technology.

[0110] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.

[0111] 4 Brief description of the drawings The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include like elements: [Brief explanation of the drawings]

[0112] [Figure 1A] 4.1 Treatment System: A system is shown including a patient 1000 wearing a patient interface 3000. The system takes the form of nasal pillows and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. 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, which takes the form of a nasal mask and receives air at positive pressure supplied by an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 takes the form of a full face mask and receives a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified by a humidifier 5000 and travels along an air circuit 4170 to the patient 1000. The patient is sleeping in a lateral sleep position. 4.2 Respiratory System and Facial Anatomy [Figure 2A] An outline of the human respiratory system including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B] 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 folds, esophagus, and trachea. [Figure 2C] A front view of the face including several features of the surface anatomy including upper lip, vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and corners of the mouth. The superior, inferior, radially inward, and radially outward directions are also indicated. [Figure 2D]A lateral 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, and 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 nasal septum 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, with the nasal turbinates shown 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 side of the nose. 4.3 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 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 large magnitude compared to the magnitude of the curvature shown in 3C. [Figure 3C]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 positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] Schematic cross-section of a structure cut at a point, where the outward normal at this point is shown and the curvature value at this point is zero. [Figure 3E] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point. The curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. 3F. [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. [Figure 3G] 1 shows a mask cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome region and saddle region are shown. [Figure 3H] 1 shows a cushion for a mask. The outer surface of the cushion is shown. The edge of the surface is shown. The path on the surface between points A and B is shown. The linear distance between A and B is shown. Two saddle regions and a dome region are shown. [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 edges of the sealing membrane in different regions of the mask. [Figure 3U] A view of the plenum chamber 3200 showing the midsagittal plane and the central contact plane. [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, the midsagittal 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, the cross-section being taken in the midsagittal plane shown in FIG. 3V. The "central contact" plane is shown. The central contact plane is perpendicular to the midsagittal plane. The orientation of the central contact plane corresponds to the orientation of the tendon 3210. The tendon 3210 rests on the midsagittal plane and contacts the cushion of the plenum chamber only at two points on the midsagittal plane (i.e., superior point 3220 and inferior point 3229). Depending on the geometry of the cushion in this region, the central contact plane may contact both the superior and inferior points. [Figure 3X] The plenum chamber 3200 of Figure 3U is shown in a use position on the face. The midsagittal plane of the plenum chamber 3200 generally coincides with the midsagittal 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 resting approximately on the selion and the lower point 3229 resting on the upper lip. 4.4 RPT Device [Figure 4A]1 shows an RPT device in accordance with one form of the present technology. [Figure 4B] 1 is a schematic diagram of an air circuit of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are indicated relative to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items located in the air pressure path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 4C] 4.5 Humidifier [Figure 5A]

[0023] Fig. 10 shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 5B] FIG. 5 shows an isometric view of a humidifier in accordance with one form of the present technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 5C] 4.6 Respiratory waveforms [Figure 6] A model of a typical human breathing waveform during sleep is shown. 4.7 Example of a patient interface for this technology [Figure 7-1] FIG. 60 shows a side view of a patient interface 6000 in accordance with an example of the present technology. [Figure 7-2] FIG. 7-2 is a front view of the patient interface of FIG. [Figure 7-3] FIG. 7-2 is a front view of a seal-forming structure 6200 of FIG. 7-1 according to an example of the present technology. [Figure 7-4] FIG. 7-2 is a perspective view of a seal-forming structure 6200 of the patient interface of FIG. 7-1. [Figure 7-5] FIG. 7-2 is a side view of the seal-forming structure of the patient interface of FIG. 7-1. [Figure 8-1] 62 shows a cross section of a seal-forming structure 6200 according to an example of the present technology. [Figure 8-2] 8-1 in accordance with an embodiment of the present technology. [Figure 8-3] 8-1 in accordance with another embodiment of the present technology. [Figure 9-1] FIG. 60 is a side view of a patient interface 6000 in accordance with another embodiment of the present technology. [Figure 9-2] FIG. 9-2 is a perspective view of the patient interface 6000 of FIG. 9-1, showing the connection port inserted into the frame. [Figure 9-3] 9-1 is a rear view of the patient interface 6000, showing the protrusions that hold the connection ports to the frame. [Figure 10-1] FIG. 60 is a front view of a patient interface 6000 in accordance with a further embodiment of the present technology. [Figure 10-2] FIG. 60 is a front view of a patient interface 6000 according to another embodiment of the present technology. [Figure 11] FIG. 60 is a side view of a patient interface 6000 in accordance with an additional embodiment of the present technology. [Figure 12-1] FIG. 90 is a perspective view of a patient interface 9000 according to an additional embodiment of the present technology. [Figure 12-2] FIG. 12-2 is a side view of the patient interface of FIG. 12-1. [Figure 12-3] FIG. 12-3 is a front view of the patient interface of FIG. [Figure 12-4] FIG. 12-2 is a side view of the seal-forming structure of the patient interface of FIG. 12-1. [Figure 12-5] 12-1 is a rear view of the patient interface of FIG. [Figure 13] FIG. 120 is a perspective view of a patient interface 12000 according to a further embodiment of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0113] 5 Detailed Description of the Embodiments of the Present Technology Before describing the present technology in further detail, it is to be understood that the present technology is not limited to the specific embodiments described herein, which may vary. It is also to be understood that the terminology used in the present disclosure is for the purpose of describing the specific embodiments described herein, and is not intended to be limiting.

[0114] The following description is provided in connection with various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. In addition, any single feature or combination of features in any of these embodiments may constitute an additional embodiment.

[0115] 5.1 Treatment In one form, the present technology includes a method of treating a respiratory disorder, the method including applying positive pressure to the entrance of the airways of a patient 1000.

[0116] In certain embodiments of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0117] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.

[0118] 5.2 Treatment System In one form, the present technology includes an apparatus or device for the treatment of disordered breathing. The apparatus or device may include an RPT device 4000 that supplies pressurized air to the patient 1000 via an air circuit 4170 to a patient interface 3000.

[0119] 5.3 Patient Interface A non-invasive patient interface 3000 in accordance with one aspect of the present technology includes the following functional features: 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 features may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional features. In use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airways to facilitate the delivery of air at positive pressure to the airways.

[0120] 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.

[0121] A patient interface 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.

[0122] A patient interface 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.

[0123] A patient interface 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.

[0124] A patient interface in accordance with one form of the present technology is configured to prevent intrusion of the patient interface structure into the mouth during use.

[0125] A non-invasive patient interface 6000 according to an example of the present technology shown in FIG. 7-1 includes a frame 6100 (which may also be called a fascia), a seal-forming structure 6200, and a positioning and stabilizing structure (e.g., headgear 6300).

[0126] FIG. 12-1 shows a non-invasive patient interface 9000 according to another example of the present technology, including a frame 9100 (which may also be called a fascia), a seal-forming structure 9200, and a positioning and stabilizing structure (e.g., headgear 9300).

[0127] A non-invasive patient interface 12000 according to an example of the present technology shown in FIG. 13 includes a frame 12100 (which may also be called a fascia), a seal-forming structure 12200, and a positioning and stabilizing structure (e.g., headgear 12300).

[0128] Patient interfaces 9000 and 12000 are substantially similar to patient interface 6000, and descriptions relating to patient interface 6000 generally apply to patient interfaces 9000 and 12000 unless otherwise specified. Below, only some similarities and differences between patient interfaces 6000, 9000, and 12000 are described. Similar features may have the same reference numeral plus "3000" or "6000," respectively.

[0129] 5.3.1 Frames In one form of the present technology, the frame 6100 of the patient interface 6000 is constructed from a flexible material. It is believed that this flexibility allows the frame to follow and conform to the curvature of the patient's face. In examples, the flexible material may have a relatively thin, sheet-like structure. It is believed that this may assist in providing a relatively low-profile profile on the patient's face, particularly in the anterior direction.

[0130] In certain examples, the flexible frame 6100 may be constructed from an airtight or impermeable woven material. The use of a woven material may help the patient interface look and feel more like clothing than a medical device, which may improve patient compliance with treatment.

[0131] In certain examples, a woven material may be used as a cover for the flexible frame 6100. The woven material is also flexible and does not interfere with the flexibility of the frame 6100. The appearance provided by the cover may be associated with a patient as an article of clothing as opposed to a medical device. To provide the feel of clothing, the woven material in the cover may also come into contact with the patient during use. For example, this may include a softer texture (e.g., as opposed to silicone), moisture-wicking capabilities, and other properties. Additional impermeability and / or structural support may be provided by providing an additional flexible material (e.g., silicone) underneath the woven material.

[0132] In certain examples, the flexible frame 6100 is constructed entirely from a woven material. The woven material may be slightly stiffened so that the flexible frame 6100 is strong enough to maintain its shape, but not so stiff that the flexible frame 6100 cannot bend or flex. The stiffening of the woven material may be achieved using coatings, laminates, stiffening threads woven into the woven material, or any similar means. Constructing the flexible frame 6100 entirely from a woven material may allow the flexible frame to be lighter than a flexible frame 6100 with a woven cover. A lighter frame 6100 may also reduce the weight placed on the patient's face, which may be beneficial to a patient wearing the patient interface 6000.

[0133] In certain examples, the flexible frame 6100 may be constructed from a foam material.

[0134] In one embodiment, one or both sides of the flexible frame material (i.e., the interior and / or exterior surfaces of the frame) are coated, layered, sealed, or otherwise provided with an impermeable surface (e.g., an impermeable silicone layer or membrane embedded within a woven material) to provide an airtight or impermeable structure. Such an arrangement results in an impermeable structure.

[0135] In certain instances, the flexible frame 6100 may be constructed from a flexible polymer. Examples of suitable flexible polymers may include silicone, thermoplastic elastomers, or other biocompatible polymers.

[0136] In certain examples, the patient interface 6000 may include one or more stiffening elements (i.e., stiffeners). In examples, the flexible frame 6100 may include stiffeners that are stiffer than the flexible material comprising the frame 6100. Such stiffeners may be used to provide one or more of support, shape, form, and / or strength to the frame 6100. By way of example, the frame 6100 may be shaped to provide clearance for the patient's nose, preventing the frame 6100 from contacting the patient's nose. Such stiffeners may include, for example, one or more of wire, polymer, fabric, thickened section, or folds. In examples, the stiffeners may be adjustable, for example, to adjust the frame 6100 to accommodate different face shapes. Adjustable stiffeners may be semi-rigid, allowing them to maintain a selected shape but are not limited to a single shape. The adjustment of the stiffener may be done once or repeatedly, depending on the material.

[0137] In one form, a flexible frame 6100 constructed entirely from a woven material may require additional support to maintain the desired shape of the frame. In other words, a frame 6100 constructed solely from woven fabric may sag or bend under gravity, preventing the desired shape of the frame 6100. Stiffeners may be added to the flexible frame 6100 to impart a three-dimensional shape to the fabric. These stiffeners may be lightweight so as not to substantially increase the weight of the flexible frame 6100. In this way, a patient may still achieve the benefits of a lightweight frame 6100, while also having the structural support of a stiffer material than woven fabric.

[0138] The stiffener may be semi-rigid. In other words, the stiffener may be stiffer than a woven material, but not completely rigid. In this way, the stiffener can provide structure to the frame 6100 while still being flexible and therefore capable of bending. The patient and / or medical professional may adjust or bend the stiffener to provide customized support for each individual patient. The stiffener may initially be semi-rigid and become rigid after a period of time. For example, a medical professional may adjust the stiffener shape so that the flexible frame 6100 fits the individual patient's face. The stiffener may then be treated (e.g., heat treated) to set the shape.

[0139] In certain forms of the present technology, the frame 6100, or portions thereof, are constructed from a transparent or at least translucent material. For example, the frame 6100 may be constructed from a thin woven fabric or a transparent polymer. The use of a transparent material may reduce the intrusiveness of the patient interface and aid in improved compliance with treatment. The use of a transparent material may aid the clinician in confirming the placement and function of the patient interface 6000. A transparent material may also aid patient compliance by allowing a patient wearing the patient interface 6000 to observe at least a portion of their oral-nasal region in a mirror, thereby allowing them to feel or wear an article of clothing rather than a medical device. Adding a transparent or translucent substance to a transparent material (e.g., coating, laminating) may provide an airtight surface without compromising the transparency of the fabric or other material. An opaque substance may be added to a small portion of the transparent material such that a portion of the transparent material remains transparent. Thus, the clinician and / or patient may be able to observe the placement of the patient interface 6000.

[0140]

[0071] In certain forms of the present technology, the frame 6100 at least partially forms the plenum chamber of the patient interface 6000. The plenum chamber may be pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure. As shown in FIG. 7-4, the seal-forming structure 6200 is constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways. The seal-forming structure 6200 has holes therein such that an airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nares. The airflow may also be delivered to the patient's mouth (i.e., if the seal-forming structure holes 6200 also surround the patient's mouth). The plenum chamber portion 6102 of the frame 6100 has a rearward-facing surface 6104 and a forward-facing surface 6106. The plenum chamber portion 6102 extends across the seal-forming structure holes 6200, and the plenum chamber portion 6102 and the seal-forming structure 6200 cooperate to form the plenum chamber. Although some contact may occur between the patient's face and the plenum chamber portion 6102 of the frame 6100, the seal-forming structure 6200 is intended to limit contact by spacing the frame 6100 away from the patient's face. The frame 6100 may also be shaped to help limit contact with the patient's face. The seal is provided by the seal-forming structure 6200.

[0141] In certain forms of the present technology, the flexible frame 6100 may extend beyond the seal-forming structure 6200 in a direction away from the hole in the seal-forming structure 6200 (i.e., away from the plenum chamber). More particularly, the side portions 6108 of the frame 6100 may extend rearward for connection to the headgear 6300 in use. In one form, the flexible frame 6100 and the headgear 6300 may be formed from a single piece of material (e.g., a woven sheet), such that the frame 6100 and the headgear 6300 are connected without a seam or other connector. The side portions 6108 may represent a transition to demarcate where the frame 6100 ends and the headgear 6300 begins. This may be indicated by a change (e.g., a tapered) in width and / or thickness of the side portions 6108 between the frame 6100 and the headgear 6300.

[0142] In some forms of the present technology, the frame 6100 (more specifically, the plenum chamber) does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized space defined by the plenum chamber. Such forms can often be less intrusive and / or more comfortable for the wearer, which can improve treatment compliance.

[0143] In certain forms of the present technology, the frame includes a plenum chamber 3200 in the form of a shell, having an inner shell surface and an outer shell surface. The inner shell surface is arranged to be at therapeutic pressure in use, and the outer shell surface is arranged to be at ambient pressure in use. Patient interfaces according to examples of the present technology are contemplated, wherein the frame is substantially rigid (e.g., as shown in FIG. 3A) and includes a seal-forming structure 6200 (e.g., as shown in FIGS. 7-3 to 8-1).

[0144] In certain forms of the present technology, the shell is constructed to be rigid when subjected to an internal pressure of less than about 30 cmH2O above atmospheric pressure.

[0145] In certain forms of the present technology, the shell is constructed from a hard plastic material (e.g., polycarbonate). One commercially available form of polycarbonate is Apec 1745 (part of a range of products sold under that trademark), manufactured by Covestro AG.

[0146] In certain forms of the present technology, the shell is constructed from a transparent material (eg, clear polycarbonate).

[0147] In certain forms of the present technology, the shell interior surface is constructed to include a concave dome-shaped region.

[0148] 5.3.2 Seal formation structure In one form of the present technology, the seal-forming structure 6200 provides a target seal-forming area and may further provide a cushioning function. The target seal-forming area is the area in the seal-forming structure where a seal may occur. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient during a given treatment session, 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). In other words, the actual seal-forming area may be larger or smaller than the target seal-forming area. Ideally, patients wish to minimize these factors from creating an actual seal-forming area that differs from the target seal-forming area. Making the actual seal-forming area smaller than the target seal-forming area may reduce treatment efficacy. Making the actual seal-forming area larger than the target seal-forming area may be painful for the patient, as treatment pressure may be applied to unintended areas of the patient's face.

[0149] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 6200 .

[0150] In certain forms of the present technology, the seal-forming structure 6200 is constructed from a biocompatible material. The biocompatible material can be any material that does not react negatively with the patient's skin. For example, the seal-forming structure 6200 can be constructed from a fabric that does not cause irritation of the patient's skin.

[0151] In one form, the seal-forming structure 6200 does not extend inside the patient's airway, in other words, the seal-forming structure 6200 does not extend into the patient's nares and / or the patient's mouth.

[0152] In one form, the seal-forming structure 6200 does not extend under the chin region in use, in other words the seal-forming structure 6200 is located entirely on the patient's face and does not extend from under the patient's chin to the patient's neck.

[0153] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 6200. Each seal-forming structure 6200 is configured to accommodate a different size and / or shape range. For example, a system may include one form of seal-forming structure 6200 that is suitable for large heads but not for small heads, and another that is suitable for small heads but not for large heads. An RPT device (described below) may assist the patient in identifying the appropriate seal-forming structure 6200 for the patient. For example, if the RPT device senses that the target seal-forming area for a particular patient has not been achieved with a particular size seal-forming structure 6200, the RPT device may provide an error to the patient, alerting the patient that they should change to a different size seal-forming structure 6200.

[0154] In one form, the seal-forming structure 6200 and the frame 6100 may be separate pieces connected together by the patient and / or clinician. The patient interface 6000 may be constructed modularly to customize the fit for each individual patient. In other words, the frame 6100 may be provided in multiple sizes (e.g., small, medium, large), and the seal-forming structure 6200 may be provided in a variety of sizes (e.g., small, medium, large). The patient and / or clinician may select one size frame 6100 and one size seal-forming structure 6200, although these may not necessarily be the same size. The selected seal-forming structure 6200 may then be connected to the selected frame 6100 with an adhesive or similar connector, thereby providing a substantially airtight interface between the frame 6100 and the seal-forming structure 6200. In other words, the frame 6100 and the seal-forming structure 6200 are connected to avoid or limit leakage through the connection interface.

[0155] In one form, the seal-forming structure 6200 and the frame 6100 may be permanently connected together. Both the frame 6100 and the seal-forming structure 6200 are provided in multiple sizes (e.g., small, medium, large). In other words, the frame 6100 and the seal-forming structure 6200 are the same size. However, in some examples, the patient interface 6000 may be customized, where the frame 6100 is formed in a different size than the seal-forming structure 6200 to provide a more precise fit for a given patient. In one example, the seal-forming structure 6200 and the frame 6100 are formed together during manufacture of the patient interface 6000, so the seal-forming structure 6200 is not separated from the frame 6100 and the patient and / or clinician do not need to assemble the patient interface 6000. If the selected size is inappropriate, the patient may change the entire patient interface 6000.

[0156] In one form, the seal-forming structure 6200 and the frame 6100 may be permanently connected together. The frame 6100 and the seal-forming structure 6200 may be provided in a single size (e.g., one size fits all or one size fits most), or in a combination of sizes to fit a wider range of patients (e.g., small-medium, medium-large). For example, a single size and / or style of patient interface 6000 may effectively seal against patients' faces with multiple sizes and shapes. In other words, a one-size-fits-all and / or one-size-fits-most patient interface 6000 may be used in place of a small / medium / large sized patient interface 6000 and still provide substantially the same effective seal against the patient's face. This may be because textiles are more flexible than other flexible materials used in the construction of seal-forming structures (e.g., silicone), allowing a single size seal-forming structure 6200 to fit a wide variety of patient faces. Alternatively and / or additionally, a combination of sizes (e.g., small-medium, medium-large) may allow for more customization to patients with different face sizes while providing similar sealing utility for a wider variety of patients. In either example, reducing the number of sizes of the patient interface 6000 may help simplify manufacturing while also improving assurance of a suitable patient interface 6000 for the patient (e.g., as the number of sizes that a patient may incorrectly select may be reduced).

[0157] In embodiments in which the frame includes the plenum chamber 3200 (i.e., the plenum chamber including the shell), 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 peripheral edge 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 6200. The seal-forming structure 6200 may extend around the entire edge of the plenum chamber 3200 in use.

[0158] 5.3.2.1 Sealing mechanism In one form of the present technology, the seal-forming structure 6200 includes a woven seal member 6202 positioned against the patient's face for sealing engagement with the patient's skin. When the frame 6100 is connected (e.g., removably or permanently) to the seal-forming structure 6200, the woven seal member 6202 enables the patient interface 6000 to maintain a positive pressure of at least 6 cmH2O.

[0159] In one of the illustrated examples, the woven fabric sealing member 6202 forms a perimeter that encompasses both the patient's mouth and the patient's nose, while in other examples, it may encompass only the nose or may partially seal the perimeter (see, for example, FIG. 13 ). When placed on the patient's face, the top of the woven fabric sealing member 6202 is positioned against the patient's nose bridge. In other words, the woven fabric sealing member 6202 contacts the patient's nose near the septum cartilage and between the patient's serrations and the tip of the nose. In the illustrated example, the woven fabric sealing member 6202 is positioned close to the tip of the nose and adjacent to the lateral cartilages and / or alar cartilages in the patient's nose. The top of the woven fabric sealing member 6202 may be substantially aligned with the Frankfurt horizontal plane of the patient's face. By placing the woven fabric sealing member 6202 close to the tip of the nose, the total volume required to form a seal is reduced because the top of the woven fabric sealing member 6202 is positioned closer to the patient's nostrils (rather than close to the serrations).

[0160] The lowest point of the fabric seal member 6202 is positioned against the chin. In other words, by positioning the fabric seal member 6202 below the patient's mouth, the patient's lower lip is contained within the pressurized volume. The patient's lower lip may move as the patient breathes, and if the fabric seal member 6202 were positioned on the lower lip, this movement could cause the fabric seal member 6202 to become obstructed (e.g., leakage could occur due to lower lip movement). Positioning the lowest point of the fabric seal member 6202 below the lower lip limits this occurrence, as it allows some freedom of movement for the lower lip without affecting the quality of the seal. Positioning the lowest point of the fabric seal member 6202 against the chin does not significantly increase the pressurized volume that needs to be generated by the fabric seal member 6202. In another example (not shown), the lowest point of the fabric seal member 6202 may be positioned against the lower lip.

[0161] The fabric seal member 6202 extends outside the patient's nose and mouth on either side of the patient's face, connecting the uppermost and lowermost points of the fabric seal member. To maintain a substantially small amount of pressurized air (i.e., avoiding including areas of the patient's cheeks significantly beyond the patient's nose or mouth), the fabric seal member 6202 may not extend significantly beyond the width of the patient's mouth. For example, because the nasolabial folds represent an area significantly wider than the width of the mouth, the fabric seal member 6202 is positioned adjacent to the patient's nasolabial folds on either side (i.e., the right and left sides) of the patient's face. In the illustrated example, the fabric seal member 6202 may be positioned outside each nasolabial fold so that each nasolabial fold is located within the pressurized volume. Like the lower lip, the nasolabial folds may represent a location of movement on the patient's face. In other words, the nasolabial folds are folds that result from movement of the patient's face. This movement may affect the quality of the seal created by the fabric seal member 6202. Because the nasolabial fold extends adjacent to the patient's nose, the fabric sealing member 6202 is positioned outside the nasolabial fold to avoid movement due to the nasolabial fold. In other examples (not shown), the fabric sealing member 6202 may contact the nasolabial fold.

[0162] In other configurations (see, e.g., FIG. 12-4 ), the woven seal member 9202 seals around the patient's nares and mouth. For example, the perimeter formed by the woven seal member 9202 encompasses the patient's mouth and at least a portion of the patient's nose (e.g., only a portion of the patient's nose). When positioned on the patient's face, the top of the woven seal member 9202 may contact the bridge of the patient's nose and be located between the patient's subnasal point and nasal tip. In the illustrated example, the top of the patient interface 9000 is positioned below the patient's nasal tip, thereby exposing the nasal tip when the patient interface 9000 is worn by the patient. The top of the woven seal member 9202 may also be substantially aligned with the Frankfurt horizontal plane of the patient's face. Positioning the woven seal member 9202 below the nasal tip further reduces the total volume required to form a seal (e.g., compared to the example above). This is because the upper end of the fabric sealing member 9202 is positioned closer to the patient's nostrils and does not seal against the bridge of the patient's nose.

[0163] The lowest point of the fabric seal member 9202 may be positioned around the chin prominence. In other words, the fabric seal member 9202 is positioned under the patient's chin, so that the patient's lower lip and chin are included in the pressurized volume. If the fabric seal member 9202 were positioned on the lower lip, the patient's lower lip may move as the patient breathes, and this movement may interfere with the fabric seal member 9202 (e.g., leakage may occur due to lower lip movement). Positioning the lowest point of the fabric seal member 9202 under the lower lip limits this occurrence by allowing some freedom of movement for the lower lip without affecting the quality of the seal. Positioning the lowest point of the fabric seal member 9202 around the chin prominence does not significantly increase the pressurized volume that needs to be generated by the fabric seal member 9202. However, it may provide an anchor point for the fabric seal member 9202 to seal and may assist in seal formation in patients of various sizes. In other words, patients of all face sizes may position the fabric seal member 9202 against their chin to create substantially the same sealing force across all face sizes (e.g., the fabric seal member 9202 may stretch around the chin prominence, and this tension may assist in proper placement of the fabric seal member 9202). In other examples (not shown), the lowest point of the fabric seal member 9202 may be positioned against the lower lip or chin (e.g., if a combination of sizes is used in the patient interface 9000 to provide a slightly more personalized fit for each individual patient).

[0164] The fabric seal member 9202 extends outside the patient's nose and mouth on either side of the patient's face, connecting the uppermost and lowermost points of the fabric seal member 9202. To maintain a substantially small amount of pressurized air (i.e., avoiding including areas of the patient's cheeks significantly beyond the patient's nose or mouth), the fabric seal member 9202 may not extend significantly beyond the width of the patient's mouth. For example, because the nasolabial folds represent areas not significantly wider than the mouth, the fabric seal member 9202 is positioned adjacent to the patient's nasolabial folds on either side (i.e., the right and left) of the patient's face. In the illustrated example, the fabric seal member 9202 may be positioned outside each nasolabial fold, thereby providing each nasolabial fold within the pressurized volume. Similar to the lower lip, the nasolabial folds may represent a location of movement on the patient's face. In other words, the nasolabial folds are folds resulting from movement of the patient's face. This movement can affect the quality of the seal created by the fabric seal member 9202. Because the nasolabial fold extends close to the patient's nose, the fabric seal member 9202 is positioned outside of the nasolabial fold to avoid movement created by the nasolabial fold. In other examples (not shown), the fabric seal member 9202 can contact the nasolabial fold.

[0165] The perimeter formed by the woven seal member 6202 may be curved along the path described above. In other words, the woven seal member 6202 may follow an arcuate path from the bridge of the nose toward the chin (or toward the patient's jaw protrusion) rather than simply a straight path. In particular, the corners of the woven seal member 6202 may be arcuate. This helps limit increased pressure concentration areas that may lead to failure (e.g., seal rupture) of the woven seal member 6202. Thus, providing an arcuate perimeter may increase the overall lifespan of the woven seal member 6202.

[0166] The fabric of the fabric seal member 6202 may be the same as the fabric used in the frame 6100, or it may be a different fabric than that used in the construction of the frame 6100. By being made from fabric, the tactile properties of the seal member 6202 may provide a soft and comfortable feel on the patient's face. Additionally, such materials may help provide a look and feel more similar to bedding than respiratory treatment equipment (e.g., constructed from plastic, silicone, etc.), increasing patient willingness to wear the patient interface and helping to improve treatment compliance.

[0167] Examples of fabric materials for the fabric seal member 6202 may include fabrics comprising polyester-polyurea copolymer fibers (ie, spandex or elastane fabrics).

[0168] In the example shown in FIGS. 7-3-8-3, the fabric seal member 6202 has a relatively thin, sheet-like structure. The fabric material may provide a relatively high level of elasticity, which assists the fabric seal member 6202 in conforming to the shape of the patient's face when forming a seal. The fabric seal member 6202 may be slightly smaller than the sealing area on the patient's face, allowing the fabric seal member 6202 to expand (e.g., stretch) when placed in a therapeutically effective position relative to the patient's face. The high level of elasticity in the fabric seal member 6202 allows the fabric seal member 6202 to expand upon contact with the patient's face and relax back to a resting position when no longer in contact with the patient's face. The width of the seal member 6202 is much greater than its thickness, which increases the surface area in contact with the patient's face and may assist in the distribution of forces imparted through the seal member 6202, thereby reducing the potential for discomfort.

[0169] In certain forms of the present technology, the woven seal member 6202 is air impermeable to avoid leakage therethrough. In examples, the woven seal member 6202 may comprise an air impermeable layer (e.g., polyurethane (e.g., thermoplastic polyurethane) or silicone). Such a layer may be provided, for example, by laminating a film or spraying a coating onto the woven seal member 6202. In other examples, the fabric used to construct the woven seal member 6202 may itself be impermeable, thereby eliminating the need for an additional impermeable layer.

[0170] In another form of the present technology, the woven seal member 6202 is made air permeable to allow for leakage control for ventilation purposes. Portions of the woven seal member 6202 may be made impermeable (e.g., coated with an impermeable layer) while other portions are not. This allows for leakage control at the portion of the woven seal member 6202 while leaving other portions impermeable. The location of the air permeable portion may be in a location that does not affect the quality of the seal between the woven seal member 6202 and the patient's skin.

[0171] 5.3.2.1.1 Compliant parts of seal-forming structures In certain forms of the present technology, the seal-forming structure 6200 includes a compliant section 6204 disposed on the rearward-facing surface 6104 of the frame 6100, with the fabric seal member 6202 disposed on the compliant section 6204. A compliant structure or component is one that deforms in response to an applied load to assume the shape of the surface against which it is placed (more particularly, the shape of the patient's face). This may assist in patient comfort through conformance points on the patient's face that may normally be subjected to excessive force when the patient interface 6000 is held in place. This may also facilitate achieving a seal by allowing the seal member 6202 freedom to conform to the curvature of the patient's face (particularly around the nose and mouth). The compliant section 6204 may be connected to the frame 6100 (e.g., by adhesive) or may be permanently formed with the frame 6100 (e.g., via a manufacturing process). In either case, the interface between the compliant section 6204 and the frame 6100 is substantially impermeable to limit leakage of pressurized air through the interface. The woven seal member 6202 may be permanently formed with the compliant section 6204. This helps create an impermeable interface between the compliant section 6204 and the woven seal member 6202 to substantially limit unintentional leakage of pressurized air through the seal-forming structure 6200.

[0172] In one example, the compliant portion 6204 may extend generally transversely or perpendicularly to the seal member 6202. When the frame 6100 and the compliant portion 6204 are connected together, at least a portion of the frame 6100 extends transversely or perpendicularly to the compliant portion 6204. As shown in FIG. 8-1 , the plenum chamber 6102 extends transversely or perpendicularly to the thickness direction such that a portion of the plenum chamber 6102 does not directly contact the compliant portion 6204 but is generally parallel to the seal member 6202. The plenum chamber 6102 may extend tangentially to the compliant portion 6204. The tangential angle may be small to approximate a parallel configuration to the seal member 6202 (see, for example, FIGS. 7-5 ). These configurations may help maintain a low profile for the patient interface 6000. Because the curvature of the center of the plenum chamber 6102 may be gradually curved toward the compliant portion 6204, the distance between the patient's face and the plenum chamber 6102 does not substantially exceed the thickness. In other words, the compliant portion 6204 may be concave relative to the patient's face, while the curvature of the compliant portion 6204 may approximate the contours of the patient's face so that the distance between the rearward-facing surface 6104 and the closest point on the patient's skin in the rearward direction remains substantially constant along the length of the compliant portion 6204. For example, because the compliant portion includes a curvature that approximates the curvature of the patient's nose, the distance between the rearward-facing surface 6104 and the tip of the patient's nose is substantially the same as the distance between the rearward-facing surface 6104 and the chin.

[0173] In one example (see, e.g., FIG. 12-4), the compliant portion 9204 may be substantially straight or may have a relatively small curvature (e.g., compared to the example in FIG. 7-5). Because the compliant portion 9204 does not need to extend around the patient's nasal tip, it may be possible to position it closer to the patient's face without curvature. Furthermore, because the compliant portion 9204 extends around the patient's chin, it needs to be in intimate contact with the patient's skin (e.g., for a low-profile appearance). Because a curvature would increase the amount of sealing, a curvature may not be necessary. The compliant portion 9204 may be spaced far enough away from the patient's mouth (as described for the compliant portion 6204) to allow the patient to breathe through their mouth with minimal impedance.

[0174] The compliant portion 6204 also allows the seal member 6202 to separate from the frame 6100, which may facilitate seal stabilization. By allowing some movement of the frame 6100 independent of the seal member 6202, forces experienced by the frame 6100 (e.g., from tube drag or from a pillow when lying down) are not fully transferred to the seal member 6202, preventing damage to the seal provided by the seal member 6202 when in use and preventing disruption of the seal necessary to maintain therapeutic pressure in the plenum chamber when the patient is sleeping. In other words, the flexibility of the plenum chamber portion 6102 may absorb at least a portion of the tensile force applied by the air circuit 4170, preventing the seal member 6202 from substantially moving onto the patient's face. This may be particularly useful when the connection port 3600 is used to connect the air circuit 4170 to the plenum chamber portion 6102 (see, e.g., FIGS. 9-2 and 9-3). Thus, because the seal member 6202 is separated from the frame 6100, there is substantially no obstruction of the seal member 6202 due to patient movement relative to the RPT device 4000 (eg, tossing and turning during sleep).

[0175] The compliant portion 6204 also functions as a spacer between the seal member 6202 and the frame 6100. This spacing may be necessary for room for the patient's nose and lips. In certain forms of the present technology, the frame 6100 may be formed or otherwise shaped to provide space for the patient's facial features (e.g., shaped to approximate the shape of the patient's face). However, it is believed that the configuration of the compliant portion 6204 may achieve this requirement while maintaining a low-profile appearance. In other words, the compliant portion 6204 shapes the frame 6100 away from the patient's face the shortest possible distance, substantially avoiding contact of the frame 6100 with the patient's skin. The positioning of the frame 6100 against the patient's face also creates a small volume within the plenum chamber. Because only the necessary space (e.g., to support a certain amount of pressurized air) is occupied by the plenum chamber, unnecessary space is eliminated, resulting in a low-profile appearance.

[0176] The low profile of the patient interface 6000 may also reduce the likelihood that any forces experienced by the frame 6100 (e.g., from tube drag or from a pillow when lying down) will be fully transferred to the seal member 6202. The low profile shape of the patient interface 6000 may improve dynamic stability (e.g., compared to a patient interface 6000 that is spaced further away from the patient's face). Dynamic stability may be particularly improved by reducing bulk on the patient's face (e.g., reducing weight closer to the patient's face) to reduce the likelihood that the patient interface 6000 will "lever off" from the patient's face during movement (e.g., turning over in sleep). In other words, a low profile may provide a fulcrum closer to the patient's face, making it less likely that the fabric seal member 6202 will disengage from the patient's face due to applied pulling forces (e.g., from the air circuit 4170).

[0177] The compliant portion 6204 is not constructed from a woven fabric. In certain forms of the present technology, the compliant portion 6204 may be made of a foam material. Examples of suitable foam materials include memory foams that return to a relaxed position when the force is removed (e.g., ResMed's UltraSoft® memory foam) or silicone foam. In examples, foam materials may be described in International Patent Application Publication No. WO 2014 / 117227, International Patent Application Publication No. WO 2016 / 054692, or International Patent Application Publication No. WO 2017 / 049359, which are incorporated herein by reference in their entirety. Thus, woven fabric, foam, and woven fabric may be used alternately in the patient interface 6000.

[0178] In another form of the present technology, the compliant portion 6204 can have another type of cellular structure that provides compliant properties (eg, a silicone honeycomb structure).

[0179] In another form of the present technology, the compliant portion 6204 can have another type of structure that provides compliant properties (eg, a silicone spring with a C-shaped or S-shaped cross section).

[0180] In certain forms of the present technology, the seal-forming structure 6200 includes one or more stiffeners. Such stiffeners may be used, for example, to provide one or more of support, shape, form, and / or strength to the seal-forming structure 6200 (and by extension, the frame 6100). In the example of FIG. 8-1 , the stiffener 6205 is disposed within the compliant section 6204, which may be formed (e.g., molded, sewn) around the stiffener 6205. In examples, the stiffener 6205 may be formed from a semi-rigid material to be adjustable, for example, to facilitate adjustment to accommodate different face shapes. In some examples, the stiffener 6205 may be repeatedly adjustable (e.g., adjustable as needed), allowing the patient and / or clinician to make multiple adjustments throughout the life of the patient interface 6000. In other examples, the stiffener 6205 may be adjustable once before setting it into a selected position. In other words, the stiffener 6205 may initially be a semi-rigid element, but may be made rigid after application of a treatment (e.g., heat). The stiffener 6205 may be customized for an individual patient and then secured in a position appropriate for the individual patient (e.g., to provide a good seal on the patient's face). In some examples, the stiffener 6205 may be exposed to the atmosphere upon connection to the seal-forming structure 6100 of the frame 6100 (see, e.g., FIG. 7-1 along the top and bottom).

[0181] The stiffener 6205 may reduce deformation of the seal-forming structure 6200 when an external force (e.g., a tensile force) is applied to the frame 6100 (e.g., via the positioning and stabilizing structure 6300). Such reduced deformation may assist in maintaining the seal-forming structure 6200 in a therapeutically effective position.

[0182] In a particular form of the present technology, the woven seal member 6202 includes an overlay portion covering at least a portion of the compliant portion 6204 and an overhanging portion extending from the compliant portion 6204, with an air gap being provided between the overhanging portion and the frame 6100. The overhanging portion of the woven seal member 6202 may be referred to herein as a flange 6206. In an example, the overhang of the woven seal member 6202 is such that the flange 6206 extends radially inward in a cantilevered manner. This arrangement may enable the seal-forming structure 6200 to utilize a pressure-assisted sealing mechanism. In use, the flange 6206 may readily respond to positive system pressure in the plenum chamber by acting on its underside to form a tight sealing engagement with a surface. A pressure-assisted seal may be less prone to leakage and may be more stable than a non-pressure-assisted seal. The pressure assist mechanism may work in conjunction with one or more other factors (eg, elastic tension in the headgear 6300, the adhesion of the seal member 6202 in contrast to the patient's face, the elasticity of the seal member 6202).

[0183] In certain forms of the present technology, the width of the woven seal member 6202 (more particularly, the width of the flange 6206) may vary along its length. While providing more width and thus surface area may be generally useful, this may be constrained in certain locations by facial features. Varying the width of the woven seal member 6202 along its length may help accommodate this. In one form, the woven seal member 6202 may be provided in a variety of sizes (e.g., small / medium / large), each with a different width that may be preselected based on the average size of a human face. In another form, the width of the woven seal member 6202 may be selected based on an individual patient. For example, the patient's face may be measured and pieces of fabric may be cut based on the measurements.

[0184] In certain forms of the present technology, the width of the compliant portion 6204 is greater than the thickness of the compliant portion 6204. When referring to the width of the compliant portion 6204, this should be understood to mean the radial dimension of the compliant portion 6204 when the patient interface 6000 is worn by a patient. When referring to the thickness of the compliant portion, this should be understood to mean the anterior-posterior dimension of the compliant portion when worn by a patient (i.e., the dimension of the compliant portion 6204 in the direction between the frame 6100 and the fabric seal member 6202).

[0185] Making the compliant portion 6204 thinner than its width may help maintain a low-profile appearance, promote lying down, and minimize bulk. Additionally, making the compliant portion 6204 thinner may aid in comfort by reducing relative movement between the frame 6100 and the woven seal member 6202, allowing the patient interface 6000 to feel comfortably snug (rather than loose). Reducing the spacing between the frame 6100 and the seal member 6202 may also reduce the impact of unsteady forces acting on the frame 6100 (e.g., due to tube drag or forces from the patient's pillow) on the seal member 6202. As noted above, this may be because the fulcrum (e.g., between the air circuit 4170 and the frame 6100) is closer to the patient's face, resulting in a smaller center of gravity. Because the stress center distance length (i.e., radius) is directly related to torque, reducing the stress center distance (e.g., by creating a patient interface with a less obtrusive appearance) reduces torque and minimizes tube drag (e.g., compared to spacing the frame 6100 away from the patient's skin).

[0186] In certain forms of the present technology, the thickness and / or width of the compliant portion 6204 may vary between different regions of the seal-forming structure 6200.

[0187] In certain forms of the present technology, at least a portion of the fabric seal member 6202 can be disposed directly on the rearward-facing surface 6104 of the plenum chamber portion 6102 of the flexible frame 6100. For example, the compliant portion 6204 may not be disposed within the nose or nasal bridge region or on the nasal bridge region of the patient's face. In other examples, the compliant portion 6204 may not be disposed proximate to the chin prominence. In another form, the compliant portion 6204 can be disposed along the entire seal-forming structure 6200.

[0188] In some forms, the frame 6100 and the compliant section 6204 can be formed from a single, similar piece of material. For example, if the frame 6100 is made of silicone and the compliant section 6204 is a silicone structure with the requisite properties, the frame 6100 and the compliant section 6204 can be manufactured as a single piece. A fabric cover can be later added around the frame and compliant section 6204 to reduce the appearance and feel of a hospital bed to the patient. In embodiments where these components are manufactured separately and then connected (e.g., when the frame 6100 is constructed from fabric), it is contemplated that using similar materials can aid in connecting the components (e.g., by welding or adhesive). These component connection methods can also be used to connect the compliant section 6204 to the fabric seal member 6202.

[0189] 5.3.2.1.2 Surface of seal-forming structure In one form, the seal-forming structure 6200 includes an area having a sticky or adhesive surface. This may be a material property of the fabric or may be separately applied to the fabric (e.g., via spraying, coating, laminating, printing, molding). In a particular form of the present technology, the woven seal member 6202 includes at least one seal-enhancing feature 6208 on the rear-facing surface (i.e., the target seal-forming area) of the woven seal member. The seal-enhancing feature 6208 may promote a good seal between the patient's face and the fabric material of the woven seal member 6202 and / or may assist in the grip of the patient's face by the woven seal member 6202. In an example, the seal-enhancing feature 6208 may increase the adhesiveness of the woven seal member 6202.

[0190] In one form, the seal-enhancing feature 6208 may include a layer of seal-enhancing material. By way of example, the coating may be polyurethane or silicone.

[0191] In another form, the seal-enhancing material of the seal-enhancing feature 6208 can be a foam material.

[0192] In one form, the seal-enhancing features 6208 may include discontinuously-distributed seal-enhancing material 6210 (i.e., gaps are formed to expose the woven seal member 6202). In such examples, the seal-enhancing material 6210 may be distributed in a variety of ways (e.g., randomly, in a pattern (e.g., stripes as shown in FIG. 8-2, dashes as shown in FIG. 8-3, or dots), spirals, spiral tracks, or combinations thereof). In locations where improved adhesion is needed or where an improved seal is possible, the woven seal member 6202 may have a higher concentration of seal-enhancing material 6210. These locations may be generalized to fit the average person, or these locations may be specific to each individual patient (e.g., based on measurements from the patient). These different patterns may provide different benefits and can be selected for a particular patient as a way to customize fit and feel for each individual patient.

[0193] In one form, the seal-enhancing features 6208 may be provided in selected region(s) along the length of the woven fabric seal member 6202. In one form, the seal-enhancing features 6208 may be provided to a greater extent (e.g., over a larger area or with a higher level of adhesion) in the selected region(s). By way of example, an area that contacts the nose or nose bridge region or is provided over the bridge of the nose region of the patient's face in use may be provided with higher seal enhancement. In one form, the seal-enhancing features 6208 may be provided along the length of the fabric.

[0194] 5.3.2.2 Nasal bridge or nasal ridge area In one form, the seal-forming structure forms a seal on the nasal bridge or nasal ridge region of the patient's face in use.

[0195] In an example, the seal-forming structure may be located on the bridge of the nose toward the patient's nasal tip. In an example, the seal-forming structure may be located on the bridge of the patient's nose below the bridge. Generally, it is desirable to reduce force applied to the nasal region because such force can cause blockage. However, reducing the retention force required for the seal-forming structure according to examples of the present technology may allow for positioning of the seal-forming structure in this region in a way that reduces the intrusiveness of the patient interface as viewed by the patient.

[0196] In another form, the seal-forming structure may be positioned entirely below the patient's nasal tip, thereby eliminating a seal formed with the bridge or ridge area of ​​the nose, which may further reduce the "intrusiveness" of the patient interface from the patient's perspective.

[0197] 5.3.2.3 Upper lip area In one form, the seal-forming structure forms a seal in use over the upper lip region (ie, upper lip) of the patient's face.

[0198] 5.3.2.4 Jaw area In one form, the seal-forming structure forms a seal over the chin area of ​​the patient's face when the seal is in use.

[0199] 5.3.2.5 Frontal area In one form, the seal-forming structure forms a seal on the forehead region of the patient's face when in use, and in such a form, the plenum chamber or frame may cover the eyes when in use.

[0200] 5.3.2.6 Nasal pillow In one form, the seal-forming structure 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.

[0201] Nasal pillows according to one aspect of the present technology include a truncated cone. At least a portion of the truncated cone forms a seal over the underside of the patient's nose, the stem, and a flexible region on the underside of the truncated cone, connecting the truncated cone to the stem. Additionally, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the base of the stem. The flexible region can function to facilitate a universal joint structure. The universal joint structure accommodates both the displacement and angle of the truncated cone and the relative movement of the structure to which the nasal pillows are connected. For example, the truncated cone can be displaced axially toward the structure to which the stem is connected.

[0202] 5.3.3 Positioning and stabilizing structures The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position by the positioning and stabilising structure 3300 in use.

[0203] In one form, the positioning and stabilizing structure 3300 provides at least enough holding force to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0204] In one form, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the attractive force on the patient interface 3000.

[0205] 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).

[0206] In one form, the holding force provided by the positioning and stabilizing structure 3300 in use is at least 6 gf / cm 2 ) x mask area (cm 2 )) is.

[0207] In one form, the force provided by the positioning and stabilizing structure 3300 in use is greater than or equal to (30(gf / cm 2) x mask area (cm 2 )) is less than.

[0208] In one form of the present technology, there is provided a positioning and stabilizing structure 3300 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 having a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0209] In one form of the present technology, there is provided a positioning and stabilizing structure 3300 that is configured so as not to be excessively large or bulky so as to interfere with a patient sleeping in a supine sleep position with the posterior region of the patient's head resting on a pillow, In one form of the present technology, the positioning and stabilizing structure 3300 provided includes a posterior portion that, in use, is no more than 2 cm thick.

[0210] 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 so as to interfere with a patient sleeping in a lateral sleeping position with the side regions of the patient's head resting on pillows. In one form of the present technology, the positioning and stabilizing structure 3300 provided includes unobtrusive side portions configured to be positioned under the patient's head when the patient is lying in a lateral sleeping position.

[0211] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that includes a tie, a portion of which is sized and configured to engage, in use, a portion of the patient's head in the region of the parietal bone (wherein the positioning and stabilizing structure has a non-rigid release portion).

[0212] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a decoupling site located between an anterior section of the positioning and stabilizing structure 3300 and a posterior section of the positioning and stabilizing structure 3300. The decoupling site does not resist compression and can be a flexible or flimsy strap, for example. The decoupling site is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling site prevents posterior forces from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0213] 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 material inner layer, and a fabric outer layer. In one form, the foam material 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.

[0214] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes stretchable (e.g., stretchable with elasticity) straps. For example, the straps can be configured to be tensioned in use to direct a force that seals the seal-forming structure against a portion of the patient's face. In one example, the straps can be configured as ties.

[0215] 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.

[0216] 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 below the inferior ear base point on the underside of the patient's head and covers or rests below the occipital bone of the patient's head.

[0217] In one form of the present technology suitable for a nasal-only 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 apart.

[0218] 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 lies down to sleep.

[0219] In certain forms of the present technology, a portion of the positioning and stabilizing structure is constructed of a breathable material that allows moisture vapor to escape and / or pass through.

[0220] 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.

[0221] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 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 of positioning and stabilizing structure 3300 that is suitable for small sized heads but not for large sized heads.

[0222] 7-1 shows a patient interface 6000 in accordance with an example of the present technology, having a positioning and stabilizing structure 6300 and a frame 6100. The positioning and stabilizing structure 6300 in this example includes a plurality of headgear straps connected to the sides 6108 of the frame 6100 to support the frame 6100 in a sealing position against the patient's face.

[0223] It is understood that a single "strap" may be formed by multiple lengths of material that are cut or formed separately and then joined at the ends to create longer lengths, or the single "strap" may be a single length of material. In examples, the various straps may be selectively adjustable (relative to one another and / or to the frame 6100). For example, connection points may be provided with apertures through which the straps may be routed and looped back on themselves to secure. For example, the straps may be releasably secured by hook-and-loop material configured to releasably couple to one another by contact, band, buckle connection, clip, or the like. In examples, one or more magnetic clips may be used to releasably secure the straps; further advantages and features of positioning and stabilizing structures including magnetic clips are described in WO2014 / 110622, which is incorporated herein by reference in its entirety. In examples of the present technology, the ability to independently adjust the left and right straps and / or the top and bottom straps can assist in shaping and adjusting the seal-forming structure 6300 to achieve a desired fit.

[0224] 7-1 , the positioning and stabilizing structure 6300 includes a pair of upper straps 6310. Each upper strap 6310 is configured to pass between a respective eye and ear of the patient. Additionally, the positioning and stabilizing structure 6300 includes a pair of lower straps 6320 configured to be positioned on each cheek of the patient below the patient's cheekbones.

[0225] In this example, the frame 6100 is held in place via a four-point connection to straps on the sides 6108 of the frame 6100. In examples, the straps may be sewn, bonded, or integrally formed with the frame 6100.

[0226] In some examples, each side portion 6108 is integrally formed with a pair of lower straps 6320. In other words, the side portions 6108 and the lower straps 6320 may be formed from a single piece of material. Each lower strap 6320 may extend into and connect to the frame 6100. The side portions 6108 may exhibit a transition to aid in coupling the pair of lower straps 6320 to the frame 6100. For example, the width of each side portion 6108 may be greater than the remainder of the lower strap 6320. The widest portion of the side portion 6108 may be coupled to the frame 6100 to more securely connect to the frame 6100 (e.g., due to an increased connection length). In other words, force from the side portions 6108 (via the upper straps 6310 and the lower straps 6320) may be applied along the entire vertical length of the frame 6100, which may help provide a sealing force around the entire periphery of the frame 6100. The frame 6100 and the side portions 6108 may be constructed from a single piece of material, and the width of the side portions 6108 may be tapered to substantially match (e.g., form a substantially smooth transition with) the shape of the frame 6100. Such a width variation may allow the upper and lower straps 6310, 6320 to be relatively narrow along the lateral sides of the patient's head (e.g., to minimize discomfort, limit contact with the patient's ears, etc.) and wider at the front of the patient's head.

[0227] In one example, the upper strap 6310 and the lower strap 6320 are each constructed as a single piece and connected at the side portion 6108. In other words, the upper strap 6310 and the lower strap 6320 on each side of the patient's head converge toward the side portion 6108 (which includes a width at least as large as the combined width of the upper strap 6310 and the lower strap 6320). The upper strap 6310 and the lower strap 6320 are each connected to the frame 6100 via the side portion 6108.

[0228] In one example (see, e.g., FIG. 11 ), each side portion 6108 can extend only from a respective lower strap 6320. In other words, each lower strap 6320 increases in width along each side portion 6108 as it approaches the frame 6100. The side portions 6108 are the transition between each lower strap 6320 and the frame 6100 and can be tapered to substantially match the shape of the frame 6100 (e.g., to form a substantially smooth transition).

[0229] The positioning and stabilizing structure 6300 may also include one or more of a parietal coronal strap 6330, a pair of lateral coronal straps 6332, and a neck strap 6334. The parietal coronal strap 6330 is configured to pass around the patient's head and be positioned against an upwardly and backwardly facing surface. The parietal coronal strap 6330 may be configured to be positioned on the parietal bone of the patient's skull. Each end of the parietal coronal strap 6330 also connects to a respective upper strap 6310 and a respective pair of lateral coronal straps 6332. Each lateral coronal strap 6332 is connected between the upper strap 6310 and the lower strap 6320 on each side of the patient's head. The lower ends of the lateral coronal straps 6332 are interconnected by a neck strap 6334. The neck strap 6334 may be configured to pass across the sagittal plane and be positioned against a downwardly and / or backwardly facing surface of the patient's head or behind the patient's neck. The neck strap 6334 may be placed above or below the occipital bone of the patient's skull.

[0230] In some forms, all of the straps that make up the positioning and stabilizing structure 6300 are constructed from a single piece of material. In other words, all of the individual straps are connected to each other without the use of fasteners (e.g., stitching, clips, magnets). This can simplify manufacturing and allow for seamless transitions between each strap.

[0231] In some forms, at least one strap of the positioning and stabilizing structure 6300 is not integrally formed with the other straps. For example, one strap may include an end that is not formed as a continuous piece of material with the additional strap. This end may be connected to the additional strap by a fastener (e.g., stitching, welding) for permanent fastening of the strap. Alternatively, the straps may be connected together by a removable fastener (e.g., mechanical latch, magnet), which allows for selective connection of the straps (e.g., for length adjustment, removal assistance).

[0232] In examples of the present technology, the positioning and stabilizing structure 6300, or at least components thereof, may be made of an elastic material. The positioning and stabilizing structure 6300 may be sufficiently stretchable that the patient interface 6000 may be attached and detached without having to detach or attach one or more of the straps. In accordance with examples of the present technology, the frame 6100 may be flexible and / or the seal-forming structure 6200 may require relatively little retention force, which may allow for the use of a positioning and stabilizing structure 6300 that stretches relatively easily compared to conventional patient interfaces.

[0233] 5.3.4 Ventilation In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow the expulsion of exhaled gases (eg, carbon dioxide).

[0234] In certain forms, the vent 3400 is configured to allow continuous vent flow from the interior of the plenum chamber 3200 to atmosphere when the pressure within the plenum chamber is positive relative to atmosphere. The vent 3400 is configured such that the magnitude of the vent flow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining therapeutic pressure within the plenum chamber in use.

[0235] Ventilation section 3400 in one form 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).

[0236] The vent 3400 may be located within the plenum chamber 3200. Alternatively, the vent 3400 is located within a decoupling structure (e.g., a swivel).

[0237] FIG. 9-1 shows an example of a vent 3400-1 provided on the connection port 3600. FIG. 9-1 also shows another example of a vent 3400-2 formed in an insert 6110 provided on the frame 6100, where the insert 6110 may be constructed of a material that is more rigid than the frame. The insert 6110 may be removably positioned within the frame 6100. The patient may be able to selectively remove the insert 6110 for cleaning. The insert 6110 may also be permanently connected to the frame 6100, in which case the insert 6110 cannot be removed without damaging the frame 6100.

[0238] FIG. 10-1 shows an example of a vent 3400-3 in which a portion of the frame 6100 is made of an air-permeable material. In certain examples, the vent 3400-3 can be made of a different material than the rest of the frame 6100 (e.g., mesh or an air-permeable woven material). In certain examples where the frame is made of a woven material, the vent 3400-3 can be provided by coating, laminating, sealing, or providing an air-impermeable surface on one or both sides of the woven material, while leaving a portion of the woven material without an air-impermeable surface. In other words, the vent 3400-3 is not coated, laminated, sealed, or provided with an air-impermeable surface, making this portion of the frame air-permeable. FIG. 10-2 shows an example of a vent 3400-4 formed directly in the frame 6100 (i.e., a hole drilled into the material of the frame 6100). The entire surface of the frame 6100 (e.g., the rear surface 6104 and the front surface 6106) may be laminated, sealed, or provided with an air impermeable surface. The holes in the vent 3400-4 extend entirely through the rear surface 6104 and the front surface 6106 to provide a flow path for fluid (e.g., exhaled air) to escape to the atmosphere.

[0239] 5.3.5 Decoupling Structures (Singular or Plural) In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0240] 5.3.6 Connection Port

[0241] The connection port 3600 allows connection to the air circuit 4170 .

[0242] 9-1 , the connection port 3600 takes the form of a ring member constructed and arranged to provide a releasable connection between the frame 6100 and the air circuit 4170. The connection port 3600 may be swivelable relative to the frame 6100 and / or the connection to the air circuit 4170 may also be swivelable. In embodiments, the connection port 3600 may include an elbow assembly configured to connect to the air circuit 4170 (e.g., via a swivel connector) and a ring member configured to connect to the frame 6100. Such an elbow assembly may be repeatedly engageable and releasably disengageable (i.e., connectable and disconnectable) from the ring member, thereby facilitating releasable or separable connectivity between the frame 6100 and the air circuit 4170.

[0243] In one example (see, e.g., FIGS. 9-2 and 9-3), the frame 6100 may include an opening 6112 (e.g., a circular opening). The opening 6112 (e.g., a circular opening) extends through the plenum chamber 6102 and provides fluid communication between a patient wearing the patient interface 6000 and the ambient environment. The connection port 3600 may have a similar shape to the opening. However, the connection port 3600 may include a protrusion 3602 that extends radially outward (e.g., from the circular connection port 3600). The connection port 3600 may be constructed of a flexible, resiliently deformable material (e.g., an impermeable fabric, silicone). When the patient compresses the connection port 3600, the protrusion 3602 may be positioned radially within the opening 6112 of the plenum chamber 6102. After the protrusion 3602 has moved through the opening 6112 (e.g., positioned adjacent the rear surface 6104), the patient may release the compression force, causing the connection port 3600 to return to its initial position. The protrusion 3602 may be positioned against the rear surface 6104 to prevent the connection port 3600 from becoming dislodged from the plenum chamber 6102 (until the connection port 3600 is again deformed). The connection port 3600 may also be tapered to form a substantially sealed interface between the frame 6100 and the connection port 3600.

[0244] 9-2 and 9-3 may also include a low-profile profile, so that tube drag due to the connection between the connection port 3600 and the frame 6100 may be similarly limited as described above.

[0245] In another example, the air circuit 4170 can be mounted directly to the frame 6100 .

[0246] 5.3.7 Forehead support In one form, the patient interface 3000 includes a forehead support 3700 (see, for example, FIG. 3A).

[0247] 7-1-11 show examples of patient interfaces of the present technology that do not include a forehead support. Variations of patient interfaces of the present technology may include a forehead support.

[0248] 5.3.8 Conduit A patient interface 3000 in accordance with embodiments of the present technology may include a conduit for obtaining pressurized flow from the connection port 3600 to the interior of the plenum chamber 3200.

[0249] In the example shown in FIG. 9-1, the patient interface 6000 includes a single conduit (shown in FIG. 9-1 as air circuit 4170) and associated connection to the frame 6100 via connection ports 3600. In the example of FIG. 9-1, the connection ports 3600 are provided at intermediate and lower positions on the frame 6100.

[0250] As shown in the examples of FIGS. 10-1 and 10-2, the patient interface 6000 may include conduits 6900 that extend along the lateral sides of the patient's head between corresponding ones of the patient's eyes and ears. For example, these conduits 6900 may extend as a pair of upper straps 6310 across similar areas of the patient's face. The conduits 6900 may be connected to a plenum chamber of the frame 6100 to provide a flow of pressurized air to the patient. These conduits 6900 may be constructed from an impermeable fabric (e.g., the same material as the frame), an elastomer (e.g., silicone), or other suitable material. For example, the conduits 6900 may be a thermoformed structure.

[0251] In the first example of FIG. 10-1, a first conduit 6900-1 is integrated into the upper strap 6310 of the positioning and stabilizing structure 6300, and a conduit connection 6902 extends from the upper strap 6310 to the plenum chamber of the frame 6100.

[0252] The first conduit 6900-1 may serve the dual functions of air delivery and force transmission. In other words, in addition to providing a flow of pressurized air to the patient, the first conduit 6900-1 may form part of the positioning and stabilizing structure 6300 and transmit associated forces to the frame 6100 to assist in sealing the fabric seal member 6202 against the patient's face.

[0253] In the illustrated example, the first conduit 6900-1 connects directly to the frame 6100 (i.e., not to the intermediate lateral portion 6108). Because the lower strap 6320 does not carry pressurized air and is connected to the frame 6100 external to the seal-forming structure 6200, the first conduit 6900-1 connects to the frame 6100 at a different location. In this case, the first conduit 6900-1 connects to the frame 6100 at a location that is proximate to the patient's nares when the patient interface 6000 is worn. In other words, the patient's nose is positioned proximate to the first conduit 6900-1, so that pressurized breathable gas is carried by the first conduit 6900-1 and directed to the patient's nares.

[0254] In one example, the first conduit 6900-1 is removably connected to the connecting portion 6902. The patient may disconnect the first conduit 6900-1 and the connecting portion 6902 to assist in cleaning the first conduit (e.g., by reducing tension applied from the positioning and stabilizing structure 6300) and / or to facilitate donning and / or doffing of the patient interface 6000. The connection between the first conduit 6900-1 and the connecting portion 6902 may be made via a snap or friction fit. The connecting portion 6902 may be removably connected to the frame 6100 in addition to or instead of the first conduit 6900-1 to provide similar utility (e.g., similar to the manner described above for the connection port 3600).

[0255] In one example, the first conduit 6900-1 and the connecting portion 6902 are permanently coupled together. The connecting portion 6902 and the frame 6100 are also permanently coupled together. In other words, the first conduit 6900-1 and the connecting portion 6902 are secured to the frame 6100 (e.g., via stitching, welding, adhesive), which may prevent the patient from removing the first conduit 6900-1 from the frame 6100.

[0256] Another example is also shown in FIG. 10-2. In this example, a second conduit 6900-2 is provided across the upper strap 6310 of the positioning and stabilizing structure 6300. The lower end of the conduit 6900-2 connects to a conduit connector 6800. The conduit connector 6800 provides a pneumatic connection within the frame 6100 to provide pressurized air flow to the plenum chamber. The conduit connector 6800 may permanently or releasably connect to an intermediate connector to the frame 6100 (e.g., via a mechanical fastener, magnet), or may connect directly to the frame 6100. The conduit connector 6800 may have a structure similar to the connection port 3600 and may be similarly detachable from the frame 6100. The conduit connector 6800 may be coupled together in any other suitable manner (e.g., to create a seal between the conduit connector 6800 and the frame 6100). For example, there may be a press fit or friction fit between the conduit connector 6800 and the frame 6100. A patient-activatable push button may be provided to release the connection between the conduit connector 6800 and the frame 6100. The conduit connector 6800 may provide other functions as described below (e.g., venting a plenum chamber, connection to the positioning and stabilizing structure 6300, and preventing asphyxiation through the inclusion of an anti-asphyxiation valve). The conduit connector 6800 may be constructed from an elastomeric material (e.g., silicone), a rigid material (e.g., plastic), and / or a woven material (e.g., the same material as the frame 6100).

[0257] The conduit 6900 may also allow for stabilization and positioning of the seal-forming structure 6200 on the patient's face. As such, the conduit 6900 may function similarly to a tie for the positioning and stabilizing structure 6300. The conduit 6900 may include features of similar conduits disclosed in International Application Publication WO 2017 / 124155 A1, which is incorporated herein by reference in its entirety. For example, the conduit 6900 of the present technology may include features of the headgear tube 3350 described in Figures 3A-3L and related description herein.

[0258] In the example of the patient interface 6000 shown in FIG. 11 , in this example, the positioning and stabilizing structure 6300 includes a pair of conduits 6900. The pair of conduits 6900 are interconnected at their upper ends and configured to be positioned on the upper and lateral surfaces of the patient's head, respectively, in use. Each of the conduits 6900 is configured to be positioned between the patient's eye and ear, respectively, in use. A lower end of each conduit 6900 is configured to fluidly connect to a plenum chamber of the frame 6100. In this example, the lower end of each conduit 6900 connects to a conduit connector 6800. The positioning and stabilizing structure 6300 includes a conduit headgear inlet 6390 at the junction of the conduits 6900. The conduit headgear inlet 6390 is configured to receive a pressurized gas flow, for example, via an elbow including the connection port 3600, and to direct the gas flow into the hollow interior of the conduit 6900. Conduit 6900 provides a pressurized gas flow to the plenum chamber of frame 6100 .

[0259] The positioning and stabilizing structure 6300 may include one or more straps in addition to the conduits 6900. In this example, the positioning and stabilizing structure 6300 includes a pair of lateral coronal straps 6332 and a pair of lower straps 6320. The rear ends of the lateral coronal straps 6332 and the lower straps 6320 are connected together by a neck strap 6334. The junction between the lateral coronal straps 6332 and the lower straps 6320 is configured to be positioned on the rear of the patient's head, thereby allowing the lateral coronal straps 6332 and the lower straps 6320 to be anchored. The front ends of the lateral coronal straps 6332 connect to the conduit 6900. In this example, each conduit 6900 includes a tab 6342 with an opening through which each lateral coronal strap 6332 can be passed and then looped back and secured to itself, thereby securing the lateral coronal straps 6332 to the conduit 6900.

[0260] In one form, the patient interface 3000 includes at least one anti-asphyxiation valve. In the example shown in FIG. 10-2, the conduit connector 6800 may include an anti-asphyxiation valve 6802. By way of example, the anti-asphyxiation valve 6802 may include an anti-asphyxiation valve flap that covers an anti-asphyxiation valve orifice in a closed position, such that the pressurized airflow entering the anti-asphyxiation valve 6802 is prevented by the anti-asphyxiation valve flap from escaping through the anti-asphyxiation valve orifice to the environment and is instead directed into the plenum chamber. The anti-asphyxiation valve flap may be configured to remain in a closed position throughout the patient's breathing cycle (i.e., inspiration and expiration). As such, the patient receives a pressurized airflow into their airway to ensure sufficient patency of the patient's airway during inspiration and expiration. When the pressurized air flow is stopped, the anti-asphyxiation valve flap is placed in an open position (with the anti-asphyxiation valve orifice uncovered), allowing the patient to breathe from the environment through the anti-asphyxiation valve orifice.

[0261] 5.3.8.1 Full Face Seal and Integral Conduit 12-1 through 12-5, the patient interface 9000 may be formed as a single piece (e.g., one-piece seamless connection), such that the frame 9100, the seal-forming structure 9200, and the positioning and stabilizing structure 9300 are integrally formed. The conduits 9900 may also be formed as a single piece along with the remainder of the patient interface 9000 (i.e., the frame 9100, the seal-forming structure 9200, and / or the positioning and stabilizing structure 9300). However, in some examples, at least one of the conduits 9900 may be disconnected from the frame 9100 (e.g., to aid in attachment / detachment, cleaning).

[0262] In some forms, the patient interface 9000 may be a full face seal or a miniature full face seal, both of which seal around both the patient's mouth and the patient's nares so that pressurized air can be inhaled through either orifice.

[0263] In some forms, the conduit 9900 is a separate structure from the positioning and stabilizing structure 9300. In other words, the strap and the conduit 9900 are not the same structure. As shown in FIG. 12-1 , the conduit 9900 is superimposed on the upper strap 9310. However, only the upper strap 9310 contacts the patient's head, and the upper strap 9310 extends wider than the conduit 9900.

[0264] In some forms, the conduit 9900 is fixed relative to the upper strap 9310. In other words, the conduit 9900 and the upper strap 9310 may be formed from a single piece, as described above. For example, the conduit 9900 may be constructed from the same woven material (e.g., a knit construction) as the positioning and stabilizing structure 9300. Being formed in one piece may prevent the conduit 9900 from moving laterally along the width of the upper strap 9310.

[0265] In one form, the upper straps 9310 may be connected to the conduits 9900 and may form part of the walls of the conduits 9900. In other words, each upper strap 9310 is connected to each conduit 9900 with a seamless connection (e.g., via heat sealing). A portion of the conduit 9900 prior to assembly may be substantially U-shaped, so that when the conduit 9900 is coupled to each upper strap 9310, the conduit 9900 is sealed. Because the upper straps 9310 form part of the interior passageway of the conduit 9900, the upper straps 9310 may be impermeable (e.g., coated with an air-impermeable material). For example, the upper straps 9310 may be impermeable only on the non-patient-contacting side (i.e., the side of the upper strap 9310 within the volume of each conduit 9900), so that the patient-contacting side includes textile properties (e.g., comfort for the patient's skin).

[0266] Because each upper strap 9310 and conduit 9900 are formed as a unitary structure, the conduit 9900 cannot move relative to the upper strap 9310. The upper strap 9310 may be configured to remain relatively static on the patient's head (e.g., to maintain a desired seal while the patient sleeps). Thus, the conduit 9900 may not be able to pull or apply force to the frame 6100, which may reduce and / or eliminate tube drag (or other forces received by the frame 6100).

[0267] In some forms, the patient interface 9000 may not include a conduit connection. Instead of the conduits 9900, the patient interface 9000 may extend directly into the compliant portion 9204 and / or the fabric sealing portion 9202. In the illustrated example, the conduits 9900 extend to an area proximate the patient's subnasal points to deliver pressurized air directly to the patient's nares. For example, the conduits 9900 may include openings (e.g., one for each nostril) that form a seal against the patient's nostril rims. Thus, the conduits 9900 directly contact at least a portion of the patient's face. This may further reduce the center of stress distance between the patient's face and each conduit 9900, thereby helping to further reduce the occurrence of tube drag.

[0268] In some forms, as shown in FIG. 12-5 , the conduit 9900 of the patient interface 9000 may include three separate openings for delivery of pressurized air to the patient's airways. For example, the first two openings 9910 (i.e., nasal openings) are nasal openings as described above, and the woven seal 9202 substantially seals around the patient's nostril edges for delivery of pressurized air to the patient's nares. The woven seal 9202 may be positioned to substantially limit overlap with the patient's nares (e.g., limit respiratory occlusion). The third opening 9920 (i.e., oral opening) may be directed substantially opposite the opening 9910 and may direct pressurized air into the cavity 9250 of the plenum chamber 9200. This air may be directed toward the patient's mouth, so that inhalation through the patient's mouth also introduces pressurized air into the patient's airways.

[0269] In some forms, the opening 9920 may not seal around the patient's mouth (e.g., similar to opening 9910) and may only redirect air toward the patient's mouth rather than directly delivering air into the patient's airway. In other words, the opening 9920 is located within the perimeter of the woven fabric sealing portion 9202. Air flowing through the opening 9920 does not flow directly into the patient's mouth. That is, the pressurized air flows into a volume pressurized by the woven fabric sealing portion 9202, which the patient may then inhale. This may allow the opening 9920 to be smaller than the size of the patient's mouth, which may improve the quality of the woven fabric sealing portion 9202 (e.g., limiting the occurrence of leaks).

[0270] In some forms, the openings 9910 and 9920 are positioned generally proximate to the center of the frame 6100. In other words, the openings 9910 and 9920 are all positioned proximate to the bridge of the patient's nose. The opening 9920 can be substantially aligned with the bridge of the nose, while the opening 9910 can be located outside the bridge of the nose and aligned with the patient's nostrils. The opening 9910 can at least partially overlap with the opening 9920.

[0271] The conduit 9900 may not include an impedance that directs the pressurized air into any one of the openings 9910 and 9920. In other words, the pressurized air may flow through all of the openings 9910 and 9920 to deliver the pressurized air to the patient's mouth and to the patient's nose.

[0272] In some forms, the patient interface 9000 may include an external stiffening portion 9350. The external stiffening portion 9350 may assist in maintaining the shape of the patient interface 9000 (e.g., particularly the conduit 9900 and / or frame 9100).

[0273] In some forms, the stiffening element may be formed from a flexible or semi-rigid material. In other words, the stiffening portion 9350 may be stiffer than the fabric sealing portion 9202, but the stiffening portion 9350 may not be formed from a rigid material (e.g., hard or semi-rigid plastic). In this manner, the patient interface 9000 may maintain a soft and / or compliant feel, which may encourage patient compliance and / or limit the use of extraneous materials (e.g., silicone).

[0274] In some forms, the stiffening element 9350 may be constructed from a woven material. For example, the stiffening element 9350 may be constructed from the same material as the rest of the patient interface 9000. This may facilitate one-piece construction of the patient interface 9000 since all of the materials are substantially identical. Additional stiffness may be imparted to the stiffening element 9350 by providing stiffening yarns within the stiffening element 9350 (e.g., before or after assembly of the patient interface 9000).

[0275] In some forms, the stiffening element 9350 may be constructed from a different material than the fabric material used in other portions of the patient interface 9000. For example, the stiffening element 9350 may be constructed from foam. The foam may be stiffer than the fabric used in other portions of the patient interface, but may also have a softer and / or more compliant feel. Furthermore, when the foam is integrated with the patient interface 9000, the fabric and foam material are formed as a unitary piece in a one-piece construction.

[0276] In some forms, the stiffening portion 9350 may extend across the patient's mouth. As shown in FIG. 12-3 , the area of ​​the patient's face from the upper lip to below the mental prominence may be covered by the stiffening portion 9350. The stiffening portion 9350 may cover the frame 9100, although in some instances the frame 9100 is constructed from the stiffening portion 9350. The stiffening portion 9350 may not completely cover the portion of the conduit 9900 that seals around the patient's nares. In other words, the top of the frame 9100 and / or the seal-forming structure 6200 are not covered by the stiffening portion 9350. This may allow for increased flexibility in the nose area, allowing the flexible material of the conduit 9900 to deform when the patient's nose comes into contact with the patient interface 9000. In particular, this may facilitate one size fits all or one size fits most patient interface 9000, as the nose portion of the patient interface 9000 may be able to deform to fit a wide variety of patient nose sizes.

[0277] In some forms, a stiffening element in front of the patient's face may help maintain the shape of the frame 9100 and / or cavity 9250. In other words, the pressurized air may apply a force to the frame 9100 as it is introduced into the cavity 9250. Because the frame 9100 may be constructed from a fabric (or other similar flexible material), the frame 9100 may have a tendency to deform (e.g., burst) due to this force. This deformation may eliminate the low-profile appearance of the patient interface 9000 and may also result in a potential increase in the center of gravity (i.e., increasing the likelihood of tube drag).

[0278] Thus, the stiffening portion 9350 maintains a substantially constant volume within the cavity 9250, thereby assisting in maintaining a low profile appearance for the patient interface 9000. Additionally, the stiffening portion 9350 may cause discomfort to the patient while sleeping, as a patient may be unable to sleep with their face in direct contact with a surface such as a pillow (due to difficulty or inability to breathe).

[0279] In some forms, the stiffening portion 9350 can extend along the upper strap 9310 and / or the lower strap 9320. The stiffening portion 9350 can be a continuous element, such that the stiffening portion 9350 extends without interruption from one upper strap 9310 to the other upper strap 9310 (and similarly from one lower strap 9320 to the other lower strap 9320).

[0280] In some forms, the lower portion 9352 of the stiffening portion 9350 may not cover the entire lower strap 9320. As shown in FIG. 12-2 , the lower portion 9352 may extend along the bottom of the lower strap 9320, while the remainder of the lower strap 9320 is left exposed by the lower portion 9352.

[0281] In some forms, the upper portion 9354 of the stiffening portion 9350 may not cover the entire upper strap 9310. As shown in FIG. 12-2 , the upper portion 9354 may extend adjacent to the conduit 9900. The upper portion 9354 may be spaced from the patient's ear, leaving the remainder of the upper strap 9310 exposed by the upper portion 9354.

[0282] In some forms, the upper portion 9354 may not extend to the coronal strap 9330 of the patient interface 9000. The upper portion 9354 may stop approximately at the junction between the upper strap 9310, the coronal strap 9330, and the lateral coronal straps 9332. This junction may be located above the helix of the ear.

[0283] In some forms, the lower portion 9352 and upper portion 9354 of the stiffening portion 9350 can form a substantially U-shaped or V-shaped shape along either side of the patient's head. The lower portion 9352 and upper portion 9354 can be positioned on either side of the patient's ears so as not to contact the patient's ears.

[0284] 12-3 , the lower portion 9352 and / or the upper portion 9354 may extend more laterally than the rest of the patient interface 9000. In other words, the lower portion 9352 and the upper portion 9354 may extend away from the patient's head (i.e., left to right) compared to the rest of the positioning and stabilizing structure 9300. For example, the upper portion 9354 may extend more laterally than the conduit 9900. This may be useful for patients who sleep in a recumbent position because the lower portion 9352 and / or the upper portion 9354 may come into contact with the sleep surface (e.g., bed, pillow) before the conduit 9900 or other portions of the positioning and stabilizing structure 9300 come into contact with the sleep surface. The lower portion 9352 and / or upper portion 9354 may act as a spacer between the conduit 9900 and the sleeping surface, which may reduce the likelihood of the conduit 9900 collapsing due to the patient's weight as a result of the patient lying down and sleeping. Because the lower portion 9352 and / or upper portion 9354 are less stiff, they may be less likely to compress and / or collapse under the patient's weight. In this way, the force of the patient's head may not be transferred to the conduit 9900.

[0285] In one form, the upper and lower portions 9354 and 9352 can extend a lateral distance away from the patient's head. In other words, a plane substantially parallel to the sagittal plane can contact the upper and lower portions 9354 and 9352. Thus, the patient's head can rest evenly on the sleep surface without tilting due to one portion 9352 extending away from the other portions 9354 and 9352.

[0286] In some forms, the lower portion 9352 and / or upper portion 9354 may be less stretchable than the remainder of the positioning and stabilizing structure 9300 (e.g., constructed from a non-rigidified fabric). Because the stiffening portion 9350 is coupled to the conduit 9900, at least a portion of the conduit 9900 (e.g., the portion proximate the patient's face) may also be less stretchable. This may further assist in reducing tube drag because it may limit the amount of stretch the conduit 9900 can undergo, and therefore the force the conduit 9900 can apply to the frame 9100.

[0287] 5.3.8.2 Integrated Conduit and Nose Seal Construction 13, the patient interface 12000 may be formed as a single piece (e.g., one-piece seamless connection), so that the frame 12100, the seal-forming structure 12200, and the positioning and stabilizing structure 12300 are integrally formed. The conduit 12900 may be formed as a single piece with the rest of the patient interface 12000.

[0288] In some forms, the patient interface 12000 may be a nasal-only seal that seals only around the patient's nostrils, which may be useful for patients who only breathe through their nose, as pressurized air is not delivered to the patient's mouth.

[0289] As shown in Figure 13, the patient interface 12000 is substantially similar to the patient interfaces of Figures 12-1 through 12-5. However, the patient interface 12000 of Figure 13 leaves the mouth exposed (i.e., the mouth is not sealed within the pressurized volume). This may lead to improved patient compliance as a lower proportion of the patient's face is covered by the patient interface 12000 and the patient may be more comfortable getting into bed wearing the patient interface 12000.

[0290] Because the patient interface 12000 delivers pressurized air only to the patient's nares, the patient interface 12000 only needs to seal around the patient's nose. In other words, because the woven fabric seal member 12202 only needs to seal around the rim of the patient's nostrils, the circumference of the woven fabric seal member 12202 can be shorter than in the patient interface 9000.

[0291] 5.3.9 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 of the gas (e.g., pressure) within the plenum chamber 3200 to be directly measured.

[0292] 5.4 RPT Device An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300 (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 can be configured to generate an airflow that is delivered to a patient's airway for treatment of, for example, one or more of the respiratory conditions described anywhere herein.

[0293] In one form, the RPT device 4000 is constructed and arranged to deliver airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0294] The RPT device may have an outer housing 4010. The outer housing 4010 is formed by two portions: an upper portion 4012 and a lower portion 4014. Additionally, the outer housing 4010 may include one or more panel(s) 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0295] The air pressure path of the pneumatic RPT device 4000 may include one or more air circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) and one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0296] One or more of the air path items may be disposed within a removable, unitary structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0297] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative, the RPT device 4000 can include more than one PCBA 4202.

[0298] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device may include one or more of the following components in an integral unit: In an alternative, one or more of the following components may be arranged as their own separate units.

[0299] 5.4.1.1 Air filter(s) An RPT device in accordance with one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0300] In one form, the inlet air filter 4112 is located at the beginning of the air pressure path upstream of the pressure generator 4140 .

[0301] In one form, an outlet air filter 4114 (eg, an antibacterial agent) is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0302] 5.4.1.2 Muffler(s) An RPT device in accordance with one form of the present technology may include a muffler 4120 or multiple mufflers 4120.

[0303] In one form of the present technology, an inlet muffler 4122 is positioned above a pressure generator 4140 in the pneumatic path.

[0304] In one form of the present technology, the outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0305] 5.4.1.3 Pressure generator In one form of the present technology, the pressure generator 4140 that generates the air flow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impellers may be disposed within a volute. The blower may deliver the air supply at a rate of, for example, up to about 120 liters / minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication WO 2013 / 020167.

[0306] The pressure generator 4140 is under the control of the therapy device controller 4240 .

[0307] In other forms, pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows.

[0308] 5.4.1.4 Transducer(s) The transducer may be internal to the RPT device or external to the RPT device. An external transducer may, for example, be located on the air circuit or form part of the air circuit (e.g., a patient interface). An external transducer may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that transmits or moves data RPT device).

[0309] In one form of the present technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal indicative of a characteristic of the airflow (e.g., flow rate, pressure, or temperature at that point in the pneumatic path).

[0310] In one form of the present technology, one or more transducers 4270 may be positioned proximate the patient interface 3000.

[0311] In one form, the signal from the converter 4270 may be filtered (eg, by low-pass, high-pass, or band-pass filtering).

[0312] 5.4.1.4.1 Flow Sensor A flow sensor 4274 according to the present technology may be based on a differential pressure transducer (eg, SDP600 series differential pressure transducers from SENSIRION).

[0313] In one form, a signal indicative of the flow rate from the flow sensor 4274 is received by the central controller 4230.

[0314] 5.4.1.4.2 Pressure Sensor A pressure sensor 4272 according to the present technology can be placed in fluid communication with the pneumatic path. One example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. Another suitable pressure sensor is a transducer from the NPA series from GENERAL ELECTRIC.

[0315] In one form, the signal from the pressure sensor 4272 is received by the central controller 4230.

[0316] 5.4.1.4.3 Motor Speed ​​Converter In one form of the present technology, a motor speed transducer 4276 may be used to determine the rotational speed of the motor 4144 and / or blower 4142. A motor speed signal from the motor speed transducer 4276 may be provided to the therapy device controller 4240. The motor speed transducer 4276 may be, for example, a speed sensor (e.g., a Hall effect sensor).

[0317] 5.4.1.5 Anti-spillback valves In one form of the present technology, an anti-spillback valve 4160 may be located between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the blower motor 4144).

[0318] 5.4.2 RPT Device Electrical Components 5.4.2.1 Power supply The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.

[0319] In one form of the present technology, the power supply 4210 powers only the RPT device 4000. In another form of the present technology, power is provided from the power supply 4210 to both the RPT device 4000 and the humidifier 5000.

[0320] 5.4.2.2 Input Devices In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow a human to interact with the device. The buttons, switches, or dials may be physical or software devices accessible via a touchscreen. The buttons, switches, or dials may be physically connected to the external housing 4010 in one form, or may communicate wirelessly with a receiver electrically connected to the central controller 4230 in another form.

[0321] In one form, input device 4220 may be constructed and arranged to allow a human to select values ​​and / or menu options.

[0322] 5.4.2.3 Central Controller In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0323] Suitable processors may include x86 INTEL processors, processors based on the ARM® Cortex®-M processor from ARM Holdings (e.g., the S®32 series of microcontrollers from ST Micro Electronics). In certain alternative forms of the present technology, 32-bit RISC CPUs (e.g., the STR9 series microcontrollers from ST Micro Electronics) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of microcontrollers manufactured by Texas Instruments) may also be suitable.

[0324] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0325] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0326] The central controller 4230 may be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220 and the humidifier 5000.

[0327] The central controller 4230 may be configured to provide output signal(s) to one or more of the output device 4290, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0328] In some forms of the present technology, the central controller 4230 is configured to implement one or more methods described herein (e.g., one or more algorithms 4300 expressed as a computer program stored in a non-transitory computer-readable recording medium (e.g., memory 4260)). In some forms of the present technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of the present technology, some methods may be performed by a remotely located device. For example, the remotely located device may determine ventilator control settings or detect respiratory-related events through analysis of recorded data (e.g., from any of the sensors described herein).

[0329] 5.4.2.4 Clock The RPT device 4000 may include a clock 4232 connected to the central controller 4230 .

[0330] 5.4.2.5 Therapy Device Controller In one form of the present technology, the therapy device controller 4240 is a therapy control module 4330 and forms part of the algorithm 4300 executed by the central controller 4230.

[0331] In one form of the present technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, the MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0332] 5.4.2.6 Protection circuit The one or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0333] 5.4.2.7 Memory In accordance with one form of the present technology, the RPT device 4000 includes memory 4260 (e.g., non-volatile memory). In some forms, the memory 4260 may include battery-powered static RAM. In some forms, the memory 4260 may include volatile RAM.

[0334] Memory 4260 may be located on PCBA 4202. Memory 4260 may take the form of EEPROM or NAND flash.

[0335] Additionally or alternatively, the RPT device 4000 includes removable memory 4260 (eg, a memory card made in accordance with the Secure Digital (SD) standard).

[0336] In one form of the present technology, the memory 4260 functions as a non-transitory computer-readable storage medium on which are recorded computer program instructions (e.g., one or more algorithms 4300) embodying one or more of the methods described herein.

[0337] 5.4.2.8 Data communication systems In one form of the present technology, a data communications interface 4280 is provided and connected to the central controller 4230. The data communications interface 4280 may be connectable to a remote external communications network 4282 and / or a local external communications network 4284. The remote external communications network 4282 may be connectable to a remote external device 4286. The local external communications network 4284 may be connectable to a local external device 4288.

[0338] In one form, the data communication interface 4280 is part of the central controller 4230. In another form, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.

[0339] In one form, remote external communications network 4282 is the Internet. Data communications interface 4280 may use wired communications (e.g., via Ethernet or fiber optics) or may use wireless protocols (e.g., CDMA, GSM, LTE) to connect to the Internet.

[0340] In one form, the local external communications network 4284 uses one or more communications standards (eg, Bluetooth or Consumer Infrared Protocol).

[0341] In one form, the remote external device 4286 is one or more computers (e.g., a cluster of networked computers). In one form, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible by an appropriately authorized person (e.g., a clinician).

[0342] The local external device 4288 may be a personal computer, a cell phone, a tablet or a remote control.

[0343] 5.4.2.9 Optional displays and output devices, including alarms Output devices 4290 according to the present technology may take the form of one or more of visual, audio and tactile units. The visual display may be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0344] 5.4.2.9.1 Display Driver The display driver 4292 receives as input characters, symbols or images to be displayed on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols or images.

[0345] 5.4.2.9.2 Display Display 4294 is configured to visually display characters, symbols, or images in response to commands received from display driver 4292. For example, display 4294 may be an eight-segment display, in which case display driver 4292 converts each character or symbol (e.g., the digit "0") into eight logic signals indicating which of the eight segments should be activated to display the particular character or symbol.

[0346] 5.5 Air Circuit An air circuit 4170, according to one aspect of the present technology, is a conduit or tube constructed and arranged such that, in use, air flow travels between two components (e.g., the RPT device 4000 and the patient interface 3000).

[0347] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0348] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating elements may take the form of a heated wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may be in communication with a controller (e.g., central controller 4230). One example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety.

[0349] 5.5.1 Oxygen delivery In one form of the present technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (e.g., upstream of the pneumatic block 4020), the air circuit 4170 and / or the patient interface 3000.

[0350] 5.6 Humidifier 5.6.1 Humidifier Overview In one form of the present technology, a humidifier 5000 is provided (for example as shown in FIG. 5A) for changing the absolute humidity of air or gas to be delivered to a patient relative to 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.

[0351] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some forms, such as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.

[0352] 5.6.2 Humidifier Components 5.6.2.1 Water reservoir According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a quantity of liquid (e.g., water) to be evaporated for humidifying the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum quantity of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., a night's sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In another form, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).

[0353] According to one embodiment, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one form, the water reservoir 5110 can be configured to encourage the air flow to travel a tortuous path through the reservoir 5110 while the air flow contacts a certain amount of water in the reservoir 5110.

[0354] According to one form, the reservoir 5110 may be laterally removable from the humidifier 5000, for example as shown in Figures 5A and 5B.

[0355] The reservoir 5110 may also be configured to inhibit liquid release from the reservoir 5110, for example, when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its subcomponents). Because the air stream to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent loss of air pressure through leakage and / or flow impedance.

[0356] 5.6.2.2 Conductive parts According to one arrangement, the reservoir 5110 includes a conductive region 5120 configured to allow efficient heat transfer from the heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conductive region 5120 may be arranged as a plate, although other shapes may be suitable. All or part of the conductive region 5120 may be constructed of a thermally conductive material such as aluminum (e.g., approximately 2 mm thick (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved with a less conductive material of appropriate geometry.

[0357] 5.6.2.3 Humidifier Reservoir Dock In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in FIG. 5B) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may include a locking feature (e.g., a locking lever 5135 configured to retain the reservoir 5110 within the humidifier reservoir dock 5130).

[0358] 5.6.2.4 Water Level Indicator The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 5A-5B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as the patient 1000 or a caregiver, about the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 may include an indication of a maximum predetermined amount of water, any fraction thereof (e.g., 25%, 50%, or 75% or an amount (e.g., 200 ml, 300 ml, or 400 ml)).

[0359] 5.6.2.5 Humidifier Transducer(s) The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of or in addition to the transducer 4270 described above. The humidifier transducer 5210 may include one or more of an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218 as shown in FIG. 5C . The humidifier transducer 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., the central controller 4230 and / or the humidifier controller 5250). In some forms, the humidifier transducer may be located external to the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signal to the controller.

[0360] 5.6.2.5.1 Pressure Transducers One or more pressure transducers 5212 may be provided to the humidifier 5000 in addition to or instead of the pressure sensor 4272 provided in the RPT device 4000.

[0361] 5.6.2.5.2 Flow Converter In addition to or instead of the flow sensor 4274 provided in the RPT device 4000, one or more flow transducers 5214 may be provided in the humidifier 5000.

[0362] 5.6.2.5.3 Temperature Converter The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures (e.g., the temperature of the heating element 5240 and / or the temperature of the air flow downstream of the humidifier outlet 5004). In some forms, the humidifier 5000 may further include a temperature sensor 5216 that detects the temperature of the ambient air.

[0363] 5.6.2.5.4 Humidity Converter In one form, the humidifier 5000 may include one or more humidity sensors 5218 that detect the humidity of a gas, such as ambient air. In some forms, the humidity sensor 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.

[0364] 5.6.2.6 Heating elements In some cases, a heating element 5240 may be provided to the humidifier 5000 to provide heat input to one or more of the volume of water in the humidifier reservoir 5110 and / or the volume of water to the airflow. The heating element 5240 may include a heat-generating component such as an electrical resistance heating track. One suitable example of the heating element 5240 is a layered heating element, for example, as described in PCT Patent Application Publication No. WO2012 / 171072, the entirety of which is incorporated herein by reference.

[0365] In some forms, the heating element 5240 may be mounted in the humidifier base 5006. In the humidifier base 5006, heat may be transferred to the humidifier reservoir 5110 primarily by conduction, as shown in Figure 5B.

[0366] 5.6.2.7 Humidifier Controller According to one arrangement of the present technology, the humidifier 5000 may include a humidifier controller 5250 as shown in FIG. 5C. In one form, the humidifier controller 5250 may be part of the central controller 4230. In another form, the humidifier controller 5250 may be a separate controller that may communicate with the central controller 4230.

[0367] In one form, the humidifier controller 5250 may receive measurements of properties (e.g., temperature, humidity, pressure, and / or flow rate) as inputs (e.g., measurements of airflow, water in the reservoir 5110 and / or in the humidifier 5000). The humidifier controller 5250 may also be configured to run or implement a humidifier algorithm and / or deliver one or more output signals.

[0368] As shown in FIG. 5C, the humidifier controller 5250 may include one or more controllers (e.g., a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240).

[0369] 5.7 Respiratory waveform Figure 6 shows a model of a typical human respiratory waveform during sleep. The horizontal axis is time, and the vertical axis is respiratory flow. Because parameter values ​​can vary, a typical breath may have the following approximate values: tidal volume, Vt, 0.5 L; inspiratory time, Ti, 1.6 seconds; peak inspiratory flow, Qpeak, 0.4 L / sec; expiratory time, Te, 2.4 seconds; peak expiratory flow, Qpeak, -0.5 L / sec. The total duration of the breath, Ttot, is approximately 4 seconds. Humans typically breathe at approximately 15 breaths per minute (BPM), with a ventilation, Vent, of approximately 7.5 L / min. A typical duty cycle, the ratio of Ti to Ttot, is approximately 40%.

[0370] 5.8 Glossary 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, other definitions may apply.

[0371] 5.8.1 General Air: In certain forms of the present technology, air may refer to atmospheric air, while in other forms of the present technology, air may refer to a combination of other breathable gases (e.g., oxygen-rich atmospheric air).

[0372] Atmosphere: In certain forms of the present technology, the term "atmosphere" should be taken to mean (i) that which is external to the treatment system or patient, and (ii) that which immediately surrounds the treatment system or patient.

[0373] For example, the ambient humidity for a humidifier may be the humidity of the air immediately surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0374] In another example, the ambient pressure may be the pressure immediately surrounding or external to the body.

[0375] In certain embodiments, ambient (e.g., acoustic) noise can be considered the background noise level in the room the patient is in, other than noise emanating from, for example, the RPT device or from the mask or patient interface. Ambient noise can originate from sources outside the room.

[0376] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy that is capable of automatically adjusting therapeutic pressure between minimum and maximum limits, for example, between breaths, depending on the presence or absence of signs of an SDB episode.

[0377] Continuous Positive Airway Pressure (CPAP) Therapy: Respiratory pressure therapy in which the therapeutic pressure is approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the entrance to the airways increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure varies during different respiratory cycles of the patient (e.g., increased in response to the detection of an indication of partial upper airway obstruction and decreased in the absence of notification of partial upper airway obstruction).

[0378] Flow Rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, reference to flow rate refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, reference to flow rate refers 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 simply called "flow."

[0379] In the example of a patient's breathing, the flow rate may be nominally positive for the inspiratory portion of the patient's breathing cycle, and therefore negative for the expiratory portion of the patient's breathing cycle. Total flow rate Qt is the flow rate of air exiting the RPT device. Vent flow rate Qv is the flow rate of air exiting the vent to allow for the outflow of exhaled gases. Leakage 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 received into the patient's respiratory system.

[0380] Humidifier: The word "humidifier" is construed to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air stream to improve the medical respiratory condition of a patient.

[0381] Leak: The term "leak" refers to unintended airflow. In one example, a leak can occur due to an imperfect seal between the mask and the patient's face. In another example, a leak can occur at the elbow to the perimeter.

[0382] Noise Conduction (Acoustic): In this document, conducted noise refers to noise that is carried to the patient by the pneumatic pathway (e.g., 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.

[0383] Noise Emission (Acoustic): In this document, radiated noise refers to noise carried by the ambient air to the patient. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the target in accordance with ISO 3744.

[0384] Ventilation noise (acoustic): In this document, ventilation noise refers to the noise generated by airflow through any ventilation (eg, vents in the patient interface).

[0385] Patient: A person with or without a respiratory disease.

[0386] Pressure: Force per unit area. Pressure can be expressed in a variety of units (e.g., cmH2O, gf / cm 2 , and hectopascals). 1cmH2O is 1g-f / cm 2 which is approximately 0.98 hectopascals. In this specification, pressures are given in units of cmH2O unless otherwise specified.

[0387] The pressure in the patient interface is designated by the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should achieve at this time, is designated by the symbol Pt.

[0388] Respiratory Pressure Therapy (RPT): The application to the airway entrance of an air supply at therapeutic pressure, typically positive pressure relative to atmosphere.

[0389] Ventilator: A mechanical device that provides pressure support to a patient while they perform some or all of the work of breathing.

[0390] 5.8.1.1 Materials Silicone or silicone elastomer: Synthetic rubber. References to silicone herein refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (in a family of products sold under this registered trademark) manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness of about 35 to about 45, as measured by ASTM D2240.

[0391] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0392] 5.8.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and to release the energy when unloaded.

[0393] Elastic: Releases substantially all of the energy upon unloading. Examples include certain silicone and thermoplastic elastomers.

[0394] Hardness: The ability of a material to resist deformation (e.g., as described by Young's modulus or the indentation hardness scale 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 do not easily deform under finger pressure, for example.

[0395] 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.

[0396] Floppy structure or component: A structure or component that changes shape (e.g., flexes) within a relatively short period of time (e.g., 1 second) when forced to support its own weight.

[0397] 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 would be setting up and maintaining a patient interface in a sealed manner against a patient airway entrance under a pressure load of, for example, approximately 20-30 cmH2O.

[0398] As one 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.

[0399] Tack or Stickiness: The tendency of a material to stick to another material (especially at room temperature) due to cohesion and / or adhesive forces between the materials in contact.

[0400] 5.8.2 Breathing cycle Apnea: According to some definitions, apnea is said to occur when flow below a predetermined threshold continues for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when some airway obstruction does not allow airflow despite patient effort. Central apnea is said to refer to a condition in which apnea is detected due to reduced or absent respiratory effort despite a patent airway. Mixed apnea is said to refer to a condition in which reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0401] Respiratory rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0402] Duty cycle: The ratio of inspiration time Ti to total breathing time Ttot.

[0403] Exercise (Respiration): Respiratory effort is said to refer to the movement made by the spontaneous breathing of a person trying to breathe.

[0404] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0405] Flow limitation: Flow limitation is understood to be a condition in a patient's breathing where an increase in patient effort does not result in a corresponding increase in flow rate. If flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0406] Flow-limited inspiration waveform types: (i) Flattening: An upswing followed by a relatively flat area, followed by a downswing. (ii) M-shaped: has two local peaks, one at the rise and one at the fall, with a relatively flat region between these two peaks. (iii) Chair-like: A single local peak occurs at the rising part, followed by a relatively flat region. (iv) Inverted chair: A relatively flat region is followed by a single local peak, which occurs on the trailing edge.

[0407] Hypopnea: By some definitions, hypopnea refers to a reduction in flow, rather than an interruption of flow. In one form, hypopnea is said to occur when flow is reduced below a threshold rate for a sustained period of time. When hypopnea is detected due to a decrease in respiratory effort, central hypopnea is said to occur. In one form, hypopnea may be considered when any of the following occur in adults: (i) A 30% decrease in patient respiration for at least 10 seconds plus an associated 4% desaturation, or (ii) A reduction in patient respiration (less than 50%) lasting at least 10 seconds and associated desaturation of at least 3% or arousal occurs.

[0408] Hyperventilation: An increase in flow to a level higher than normal.

[0409] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0410] Patency (Airway): The degree to which the airway is open or the extent to which it is open. Airway patency is an opening. Airway patency can be quantified, for example, with a value of 1 indicating open and a value of 0 indicating closed (obstructed).

[0411] Positive end-expiratory pressure (PEEP): The pressure above atmosphere in the lungs that exists at the end of expiration.

[0412] Peak flow (Qpeak): The maximum value of flow during the inspiratory portion of the respiratory flow waveform.

[0413] Respiratory airflow, airflow, patient airflow, respiratory airflow (Qr): These terms may be understood to refer to the RPT device's estimate of respiratory airflow, and are used in contrast to "true respiratory flow" or "true respiratory airflow," which is the patient's actual respiratory flow, usually expressed in liters / minute.

[0414] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without extra effort. In principle, the inhaled volume V i Since the volume of air inhaled is equal to the expiratory volume Ve (the volume of air exhaled), the single tidal volume V t can be defined as equal to either quantity. In practice, the tidal volume V t is some combination (e.g., intake volume V i and expiratory volume Ve).

[0415] (Inspiration) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0416] (Expiratory) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0417] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0418] Typical Recent Ventilation: The ventilation value around which recent values ​​of ventilationVent over a given time scale tend to cluster (i.e., the degree to which recent values ​​of ventilation tend to be centered).

[0419] Upper Airway Obstruction (UAO): Includes both partial and total upper airway obstruction. May be associated with a state of flow limitation in which flow may increase or decrease slightly with increasing pressure differential across the upper airway (Starling resistor behavior).

[0420] Vent: A measure of the rate of gas exchange performed by a patient's respiratory system. Measurements of ventilation may include either or both inspiratory and expiratory flow per unit time. When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes given simply as volume and is understood as volume per minute.

[0421] 5.8.3 Ventilation Adaptive servo-ventilator (ASV): A servo-ventilator that does not have a fixed target ventilation but is variable. The variable target ventilation can be learned from some characteristic of the patient (e.g., the patient's breathing characteristics).

[0422] Backup Rate: A ventilator parameter that establishes the minimum respiratory rate (typically in breaths per minute) that will be delivered to the patient by the ventilator (when not triggered by spontaneous breathing efforts).

[0423] Cycle: 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 breath delivery.

[0424] Expiratory Positive Airway Pressure (EPAP): The base pressure to which varying pressures are added during a breath to produce the desired mask pressure that the ventilator attempts to achieve at a given moment.

[0425] End Expiratory Pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory portion of the breath. If the pressure waveform template Π(Φ) has a value of zero at the end of expiration (i.e., Π(Φ)=0 when Φ=1), then EEP is equal to EPAP.

[0426] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0427] Pressure Support: A number indicating the increase in pressure during ventilator inspiration compared to the corresponding ventilator expiration, and refers primarily to the pressure difference between the maximum inspiratory pressure and the base pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure support refers to the difference the ventilator attempts to achieve (rather than the difference it actually achieves).

[0428] Servo-ventilator: A ventilator that has both patient ventilation and target ventilation, and adjusts the level of pressure support to bring the patient ventilation closer to the target ventilation.

[0429] 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. However, if the device fails to detect a breath within a predetermined period of time, the device automatically begins breath delivery.

[0430] Swing: A term equivalent to pressure assistance.

[0431] Triggered: When a ventilator delivers a breath of air to a spontaneously breathing patient, the ventilator is said to be triggered to deliver a breath when the patient himself initiates the breathing portion of the breathing cycle.

[0432] 5.8.4 Anatomy 5.8.4.1 Facial Anatomy Ala: The outer wall or "wing" of each nostril (plural: alar)

[0433] Alare: The outermost point on the ala of the nose.

[0434] Alar curvature (or alar crest) point: The most posterior point on the curved baseline of each alar, found in the crease formed by the union of the alar and cheek.

[0435] Pinna: the entire visible part of the ear.

[0436] (Nasal) skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0437] (Nasal) cartilaginous rami: The cartilaginous rami of the nose include the septal cartilage, lateral cartilage, greater cartilage, and lesser cartilage.

[0438] Columella: The piece of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0439] Columella angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt horizontal and intersecting the subnasal point.

[0440] Frankfort horizontal plane: A line extending from the most inferior point of the orbital rim to the left auricular point, which is the deepest point of the auricle from the superior side of the notch to the tragus.

[0441] Glabellar: Located in the soft tissue, the most prominent point in the midsagittal direction of the forehead.

[0442] Lateral nasal cartilage: a generally triangular plate of cartilage whose upper margin is attached to the nasal bone and the frontal process of the maxilla, and whose lower margin is connected to the greater alar cartilage.

[0443] Lower lip (labrale inferius): the point on the face between the mouth and chin, lying in the midsagittal plane.

[0444] Upper lip (labrale superioris): the point on the face between the mouth and nose, lying in the midsagittal plane.

[0445] Greater alar cartilage: a cartilaginous plate located beneath the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.

[0446] Nostrils (alar): Generally ellipsoidal alar openings that form the entrance to the nasal cavity. The singular form of nostrils is naris (nose hole). These nostrils are separated by the nasal septum.

[0447] Nasolabial fold or nasolabial crease: a fold or groove of skin that runs from each side of the nose to the corners of the mouth, separating the cheek from the upper lip.

[0448] Nasolabial angle: the angle between the bridge of the nose and the upper lip, intersecting with the subnasal point.

[0449] Inferior ear point: lowest point of attachment of the pinna to the facial skin.

[0450] Superior auricular point: the highest point of attachment of the pinna to the facial skin.

[0451] Nasal tip: The most prominent point or tip of the nose, which can be seen in a lateral view of the rest of the head.

[0452] Philtrum: midline groove extending from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0453] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0454] Nasal ridge: The nasal ridge is the midline prominence of the nose, extending from the serion to the apex.

[0455] Sagittal plane: A vertical plane running from anterior (front) to posterior (rear). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0456] Cerion: Located on the soft tissue, it is the most concave point on the area of ​​the frontonasal suture.

[0457] Septal cartilage (nose): The nasal septum cartilage is part of the septum, which divides the anterior part of the nasal cavity.

[0458] Nasal alar nasal basin: the point on the lower periphery of the alar base where it joins with the skin of the upper (top) lip.

[0459] Subnasal point: Located on the soft tissue, the point where the columella joins the upper lip in the midsagittal plane.

[0460] Supramenton: The most concave point in the midline of the lower lip between the lower lip midpoint and the soft tissue pogonion. 5.8.4.2 Skull anatomy

[0461] Frontal bone: The frontal bone contains the squama frontalis, a large vertical portion that corresponds to the area known as the forehead.

[0462] Mandible: The mandible forms the lower jaw. The mental protuberance is a bony protuberance in the jaw, forming the chin.

[0463] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the orbit. The frontal process of the maxilla projects upward by the sides of the nose and forms part of its lateral border.

[0464] Nasal bones: The nasal bones are two small, rectangular bones that vary in size and shape from person to person. They lie side by side in the middle and upper parts of the face, and their junction forms the "bridge" of the nose.

[0465] Nasion: the intersection of the frontal bone and the two nasal bones, a concave area directly between the eyes and the upper side of the bridge of the nose.

[0466] Occipital bone: The occipital bone is located at the back and underside of the skull. It contains the foramen magnum, an oval hole through which the intracranial cavity connects with the vertebral canal. The curved plate posterior to the foramen magnum is the squama occipitalis.

[0467] Orbit: bony cavity in the skull that contains the eyeball.

[0468] Parietal bones: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0469] Temporal bone: The temporal bone is located on the base and sides of the skull and supports parts of the face known as the temples.

[0470] Cheekbones: The two cheekbones in the face are located in the upper and outer parts of the face and form the cheek ridges.

[0471] 5.8.4.3 Respiratory system anatomy Diaphragm: A sheet of muscle that runs over the lower rib cage. The diaphragm 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.

[0472] Larynx: The larynx or voice box that houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0473] Lung: respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchi, and terminal bronchioles. The respiratory zone includes the respiratory bronchi, alveolar ducts, and alveoli.

[0474] 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 the sides of the nasal cavity are three horizontal extensions called nasal conchae (singular "concha") or turbinates. The nasal cavity is anteriorly connected to the nose, and posteriorly to the choanae, which open into the nasopharynx.

[0475] Pharynx: The part of the throat located immediately below (inferior to) the nasal cavity and above the esophagus and larynx. The pharynx is traditionally divided into three parts: the nasopharynx (upper pharynx) (nasal part of the pharynx), the oropharynx (mid pharynx) (oral part of the pharynx), and the hypopharynx (low pharynx).

[0476] 5.8.5 Patient Interface Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that vents to atmosphere in a fail-safe manner to reduce the risk of excessive CO2 rebreathing by the patient.

[0477] Elbow: An elbow is an example of a structure that directs the axis of airflow moving therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a generally circular cross section. In another form, the elbow may have an oval or rectangular cross section. In certain forms, the elbow may be rotatable relative to the mating component, for example, approximately 360 degrees. In certain forms, the elbow may be detachable from the mating component, for example, via a snap connection. In certain forms, the elbow may be assembled to the mating component via a one-time snap during manufacturing, but cannot be removed by the patient.

[0478] 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.

[0479] Functional Dead Space: (insert description here)

[0480] Headgear: Headgear is taken to mean a form of positioning and stabilizing structure designed for use on the head. For example, the headgear may include a collection of one or more posts, ties, and stiffeners configured to position and hold the patient interface in place on the patient's face for delivery of respiratory therapy. Some ties are formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).

[0481] Membrane: Membrane is taken to mean a typically thin-walled element, preferably substantially non-resistant to bending and resistant to stretching.

[0482] Plenum Chamber: Mask plenum chamber is taken to mean a portion 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. In some embodiments, the frame may form part of the wall of the mask plenum chamber. In some embodiments, the shell may form part of the wall of the mask plenum chamber.

[0483] 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 "seal" or achieve a "sealing" effect between them without the need for a separate "sealing" element itself.

[0484] Shell: A shell is taken to mean a curved, relatively thin structure that has bending, tensile, and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0485] Stiffener: A stiffener is taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0486] Strut: A strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0487] 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 less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a mating cylindrical conduit. In use, there is little leakage of air flow from the swivel.

[0488] Tie (noun): A structure designed to resist tension.

[0489] Venting: (noun): A structure that allows airflow into the ambient atmosphere inside a mask or conduit, allowing clinically effective flushing of exhaled gases. 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.

[0490] 5.8.6 Structural Shape 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.

[0491] To facilitate the description of the shape and surface of a three-dimensional structure, we first consider a cross section at a point p through the surface of the structure. See Figures 3B-3F. Figures 3B-3F show an example cross section at point p on the surface and an example of the resulting planar curve. Figures 3B-3F also show the outward normal vector at p. The outward normal vector at 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.

[0492] 5.8.6.1 Curvature in one dimension The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, 1 / radius of the circle tangent to the curve at p).

[0493] Positive curvature: If the curve at p bends toward the outward normal, the curvature at that point is taken to have a positive value (if our fictitious little person were to walk away from point p, they would 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 often called concave.

[0494] Zero curvature: If the curve at p is a straight line, the curvature is taken as zero (if this imaginary little person walks away from point p, they can walk on a horizontal plane that is neither pointing up nor pointing down). See Figure 3D.

[0495] Negative curvature: If the curve at p bends away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if this fictitious little person were to walk away from point p, they would 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 often called convex.

[0496] 5.8.6.2 Two-dimensional surface curvature 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 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.

[0497] Principal curvature and direction: The directions of the normal plane in 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 curvature at p is the curvature in the principal direction.

[0498] Surface region: A set of connected points on a surface. This set of points within a region may have similar properties (e.g., curvature or sign).

[0499] Saddle region: A region where the principal curvatures at each point have opposite signs (i.e., one positive sign and the other negative sign) (depending on the direction a hypothetical person who may be walking uphill or downhill is facing).

[0500] Dome area: an area where the principal curvatures at each point have the same sign: either both positive ("concave dome") or both negative ("convex dome")

[0501] Cylindrical region: A region in which one principal curvature is zero (or zero, for example, within a manufacturing tolerance) and the other principal curvature is non-zero.

[0502] Planar region: A region of a surface where both principal curvatures are zero (or are zero within a manufacturing tolerance, for example).

[0503] Surface Edge: The boundary or limit of a surface or area.

[0504] 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 that includes, for example, 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.)

[0505] Path Length: In certain forms of the present technology, "path length" is taken to refer to 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 fictional person is the distance walked along the path on the surface.)

[0506] Straight-line distance: Straight-line distance is the distance between two points on a surface, but does not take the surface into account. 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. (For a fictional person, straight-line distance corresponds to the distance as the crow flies.)

[0507] 5.8.6.3 Space curve Space Curve: Unlike a plane curve, a space curve does not necessarily exist within any particular plane. A space curve may be closed, i.e., it has no endpoint. A space curve may 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) may trace a space curve. In general, a space curve can be described by the curvature and twist at each point on the space curve. Torsion 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 with respect to the tangent, normal, and binormal vectors at that point.

[0508] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude 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 fictional character were flying along the curve and fell off their vehicle at a particular point, the direction of the tangent vector would be the direction they would be traveling.

[0509] Unit normal vector: As the fictional character 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.

[0510] Binormal unit vector: The binormal unit vector is perpendicular to both 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 (Figure 3O).

[0511] Oscillating plane: the plane containing the unit tangent vector and the unit principal normal vector. See Figures 3O and 3P.

[0512] Torsion of a Space Curve: The torsion at 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 tangential plane. A space curve that lies within a plane has zero torsion. If the space curve deviates from the tangential 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 tangential 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, because T2 > T1, the magnitude of torsion near the top coil of the spiral in Figure 3S is greater than the magnitude of torsion of the bottom coil of the spiral in Figure 3S.

[0513] 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).

[0514] 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.

[0515] 5.8.6.4 Holes A surface may have one-dimensional holes (e.g., holes bounded by a planar or space 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.

[0516] A structure can 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 can 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 can include a one-dimensional hole (e.g., at its inlet or its outlet) and can 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.

[0517] 5.9 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.

[0518] Unless otherwise clearly indicated from the context and unless 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 the range, and for any other stated or intervening value in the stated range, is encompassed by the technology. The upper and lower limits of these intervening ranges, independently included in the intervening range, are also encompassed by the technology if they specifically exceed the limits in the stated range. If the stated range includes one or both of these limits, then ranges exceeding either or both of these stated limits are also encompassed by the technology.

[0519] Furthermore, when a value or values ​​are embodied herein as part of the present technology, unless otherwise specified, it is understood that such values ​​may be approximated and may be used to any appropriate significant figures to the extent practical technical practice permits or requires.

[0520] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0521] Although particular materials are described as being suitable for use in the construction of components, obvious alternative materials having similar properties may be substituted. Furthermore, unless stated to the contrary, any and all components described herein are understood to be manufacturable and therefore may be manufactured collectively or separately.

[0522] Please note that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0523] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of these publications. The publications mentioned herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology does not antedate such publications by virtue of prior patents. Furthermore, the dates of publications mentioned may differ from the actual publication dates, which may require independent confirmation.

[0524] The terms "comprises" and "comprising" should be construed as referring to elements, components, or steps in a non-exclusive sense, indicating that a described element, component, or step may be present in, utilized with, or combined with other elements, components, or steps not specifically described.

[0525] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found in the disclosure or claims as a whole. These headings should not be used in interpreting the scope of the claims or the claim limitations.

[0526] Although the technology herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may indicate specific details unnecessary for the practice of the technology. For example, although the terms "first" and "second" (etc.) are used, unless otherwise specified, these terms are not intended to indicate any order but are used to distinguish between separate elements. Furthermore, although the process steps in the method may be described or illustrated in an ordered manner, such an order is not required. Those skilled in the art will recognize that such an order can be changed and / or aspects thereof can be performed simultaneously or even synchronously.

[0527] It is therefore to be understood that numerous modifications may be made in the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present technology. [Explanation of symbols]

[0528] 1000 patients 1100 Bedmate 3000 Patient Interface 3100 Seal forming structure 3200 Plenum Chamber 3210 Tendon 3220 Upper point 3229 Down 3300 Positioning and Stabilizing Structures 3400 Ventilation section 3600 connection port 3602 Protrusion 4000 RPT devices 4010 Outer Housing 4012 Upper 4014 Lower 4015 Panel 4016 chassis 4018 Handle 4020 Pneumatic Block 4110 Air Filter 4112 Inlet Air Filter 4114 Outlet air filter 4120 Muffler 4122 Inlet muffler 4124 Exit muffler 4140 Pressure Generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air Circuit 4180 Supplemental Oxygen 4200 Electrical Components 4202 Printed Circuit Board Assembly (PBCA) 4210 Power supply 4220 input devices 4230 Central Controller 4232 Clock 4240 Therapy Device Controller 4250 protection circuit 4260 memory 4270 Converter 4272 Pressure Sensor 4274 Flow Sensor 4276 Motor Speed ​​Converter 4280 data communications interface 4282 Remote External Communications Network 4284 Local External Communication Network 4286 Remote External Device 4288 Local Foreign Device 4290 output device 4292 display driver 4294 display 5000 humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier Base 5110 Humidifier Reservoir 5110 Reservoir 5120 Conductive parts 5130 Humidifier Reservoir Dock 5135 Lock lever 5150 Water Level Indicator 5210 Humidifier Converter 5212 Air pressure sensor 5214 Flow Converter 5216 Temperature Sensor 5218 Humidity Sensor 5240 heating element 5250 Humidifier Controller 5251 Central Humidifier Controller 5252 Heating Element Controller 5254 Air Circuit Controller 6000 Patient Interface 6100 frames 6102 Plenum chamber part 6104 Rear facing surface 6106 Front facing surface 6108 Lateral site 6110 Frame Insert 6112 Opening 6200 Seal forming structure 6202 Fabric sealing materials 6204 Compliant Section 6205 Rigidizer 6206 flange 6208 Seal Improvement Feature 6210 Seal Improvement Materials 6300 Positioning and Stabilizing Structure 6310 Upper strap 6320 Lower strap 6330 Crown Strap 6332 Lateral crown strap 6334 Cervical strap 6342 tabs 6390 Conduit Headgear Inlet 6800 Conduit Connector 6802 Anti-choking valve 6900 Conduit 6902 Pipe connection part 9000 Patient Interface 9100 frames 9102 Plenum chamber part 9104 Rear facing surface 9106 Front facing surface 9200 Seal forming structure 9202 Fabric sealing materials 9204 Compliant Department 9250 cavity 9300 Positioning and Stabilizing Structure 9310 Upper strap 9320 Lower Strap 9330 Crown Strap 9332 Lateral Crown Strap 9350 Stiffening part 9352 Lower 9354 Upper 9900 Conduit 9910 Nasal opening 9920 Oral opening 12000 Patient Interface 12100 frames 12102 Plenum chamber part 12200 Seal forming structure 12202 Fabric sealing material 12204 Compliant Section 12300 Positioning and Stabilizing Structures 12310 Upper strap 12320 Lower strap 12330 Crown Strap 12332 Lateral crown strap 12350 Stiffness imparting part 12352 Lower 12354 upper 12900 Catheter

Claims

1. A patient interface comprising: Frame with at least 6 cmH above ambient air pressure ２ a frame at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O; 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, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle; The seal-forming structure comprises: a compliant portion provided on the frame; one or more stiffening elements disposed within the compliant section, the one or more stiffening elements being constructed from a different material than the compliant section; a woven fabric seal member provided on the compliant portion and adapted for sealing engagement with a patient's face in use, the woven fabric seal member including an overhanging portion extending from the compliant portion.

2. 10. The patient interface of claim 1, wherein the frame includes a plenum chamber portion, the compliant portion being disposed on a rearwardly facing surface of the plenum chamber portion, the plenum chamber portion extending over an aperture in the seal-forming structure through which airflow at therapeutic pressure is delivered to at least an entrance to the patient's nares.

3. The patient interface of claim 1 or 2, wherein the one or more stiffening elements are exposed to the atmosphere.

4. 4. A patient interface according to claim 1, wherein the one or more stiffening elements limit compression of the compliant section and maintain a thickness between the frame and the fabric sealing member.

5. A patient interface according to any preceding claim, wherein the width of the fabric seal member varies along its length.

6. A patient interface according to any preceding claim, wherein the fabric seal member is air impermeable.

7. A patient interface according to any preceding claim, wherein the fabric seal member is air permeable.

8. A patient interface according to any preceding claim, wherein the width of the compliant section is greater than the thickness of the compliant section.

9. A patient interface according to any preceding claim, wherein the width of the compliant section is less than or equal to the thickness of the compliant section.

10. A patient interface according to any preceding claim, wherein the thickness of the compliant portion varies between different regions of the seal-forming structure.

11. A patient interface according to any preceding claim, wherein the thickness of the compliant portion varies between different regions of the seal-forming structure.

12. A patient interface according to any preceding claim, wherein the compliant portion comprises a foam material.

13. A patient interface according to any preceding claim, wherein the compliant portion has a structure that provides it with compliant properties.

14. A patient interface according to any preceding claim, wherein the overhanging portion of the fabric seal member extends in a radially inward direction from the compliant portion.

15. A patient interface according to any preceding claim, wherein an overhanging portion of the fabric seal member provides a pressure assisted seal.

16. A patient interface according to any preceding claim, wherein the fabric seal member includes at least one seal-enhancing feature on a rearward-facing surface thereof.

17. The patient interface of claim 16, wherein the seal-enhancing feature increases the tack of the fabric seal member.

18. 18. A patient interface according to claim 16 or 17, wherein the seal-enhancing feature comprises a layer of seal-enhancing material.

19. A patient interface according to any one of claims 16 to 18, wherein the seal-enhancing feature comprises discontinuously applied seal-enhancing material.

20. 20. A patient interface according to claim 18 or 19, wherein the seal enhancing material is one or more of polyurethane and silicone.

21. A patient interface according to any one of claims 16 to 20, wherein the seal-enhancing features are provided in selected area(s) along the length of the fabric seal member.

22. A patient interface according to any one of claims 16 to 20, wherein the seal-enhancing features are provided to a greater extent in selected areas than in one or more other areas.

23. 23. A patient interface according to claim 22, wherein the seal-enhancing features are provided to a greater extent in an area that, in use, contacts the nose or nose bridge area or over the bridge of the nose area of ​​the patient's face.

24. A patient interface according to any one of claims 16 to 20, wherein the seal-enhancing features are provided along the entire length of the fabric seal member.

25. A patient interface according to any preceding claim, wherein the frame is flexible.

26. A patient interface according to any preceding claim, wherein the frame is constructed from a flexible material.

27. A patient interface according to any preceding claim, wherein the frame is constructed from a woven material.

28. A patient interface comprising: Frame with at least 6 cmH above ambient air pressure ２ a frame formed at least in part from a fabric, the frame partially defining a plenum chamber pressurizable to a therapeutic pressure of O; a seal-forming structure constructed and arranged to form a seal against an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle, said seal-forming structure including a fabric sealing member adapted for sealing engagement with the patient's face in use; a positioning and stabilizing structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure being formed at least in part from a textile; the frame includes a plenum chamber portion, the seal-forming structure is disposed on a rearwardly facing surface of the plenum chamber portion, the plenum chamber portion extends over an aperture in the seal-forming structure; the frame includes a side portion extending beyond the seal-forming structure in a direction away from the hole in the seal-forming structure; A patient interface, wherein the lateral portions connect the frame to the positioning and stabilizing structure via a one-piece woven structure.

29. A patient interface comprising: Frame with at least 6 cmH above ambient air pressure ２ a frame at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O; 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, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle; The seal-forming structure comprises: a compliant portion provided on the frame; one or more stiffening elements disposed within the compliant section, the one or more stiffening elements being constructed from a different material than the compliant section; a fabric seal member provided on the compliant portion and adapted for sealing engagement with the patient's face in use.

30. A patient interface comprising: Frame with at least 6 cmH above ambient air pressure ２ a frame at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O; 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, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle; the seal-forming structure includes a compliant portion on the frame and a fabric sealing member that surrounds an entrance to the patient's airway and is adapted for sealing engagement with the patient's face in use; A patient interface wherein the frame and seal member are constructed at least in part from a woven material, and the compliant portion is constructed from a resilient material different from the woven material.

31. A patient interface comprising: Frame with at least 6 cmH above ambient air pressure ２ a frame at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O; 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, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle; The seal-forming structure comprises: a compliant section provided on the frame, the width of the compliant section being greater than the thickness of the compliant section; a fabric seal member provided on the compliant section and adapted for sealing engagement with the patient's face in use, the fabric seal member having a cantilevered configuration relative to the compliant section, the frame extending generally parallel to the fabric seal member.

32. A patient interface comprising: Frame with at least 6 cmH above ambient air pressure ２ a frame at least partially formed from a fabric, the frame at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O; 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, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle; the seal-forming structure includes a fabric sealing member adapted for sealing engagement with the patient's face in use; the fabric seal member includes at least one seal-enhancing feature on a rearward-facing surface of the fabric seal member; A patient interface wherein the frame extends generally parallel to the fabric seal member along the length of the seal-forming structure.

33. A patient interface comprising: Frame with at least 6 cmH above ambient air pressure ２ a frame at least partially defining a plenum chamber pressurizable to a therapeutic pressure of O; 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, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to, in use, maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle; the seal-forming structure includes a compliant section on the frame, a stiffening element within the compliant section, and a seal member adapted for sealing engagement with a patient's face in use; A patient interface wherein the frame and seal member are constructed at least in part from a woven material, and the compliant portion is constructed from a resilient material different from the woven material.

34. 34. A patient interface according to claim 33, wherein the frame is constructed entirely of a woven material.

35. 35. A patient interface according to any one of claims 33 to 34, wherein the frame includes a plenum chamber portion, the seal-forming structure being provided on a rearward facing surface of the plenum chamber portion, the plenum chamber portion extending over holes in the seal-forming structure through which airflow at therapeutic pressure is delivered to at least the entrance to the patient's nares.

36. 36. A patient interface according to claim 35, wherein the frame includes lateral portions that extend beyond the seal-forming structure in a direction away from the aperture in the seal-forming structure.

37. A patient interface according to any one of claims 33 to 36, wherein the stiffening element is exposed to the atmosphere.

38. A patient interface according to any one of claims 33 to 37, wherein the seal-forming structure comprises a fabric sealing member adapted for sealing engagement with the patient's face in use.

39. 39. A patient interface according to claim 38, wherein the fabric seal member surrounds an entrance to the patient's airway and is adapted for sealing engagement with the patient's face in use.

40. 40. A patient interface according to claim 38 or 39, wherein the width of the fabric seal member varies along its length.

41. A patient interface according to any one of claims 38 to 40, wherein the fabric seal member is air impermeable.

42. A patient interface according to any one of claims 38 to 40, wherein the fabric seal member is air permeable.

43. A patient interface according to any one of claims 33 to 42, wherein the width of the compliant section is greater than the thickness of the compliant section.

44. A patient interface according to any one of claims 33 to 43, wherein the thickness of the compliant portion varies between different regions of the seal-forming structure.

45. A patient interface according to any one of claims 33 to 44, wherein the thickness of the compliant portion varies between different regions of the seal-forming structure.

46. A patient interface according to any one of claims 33 to 45, wherein the compliant portion comprises a foam material.

47. A patient interface according to any one of claims 33 to 46, wherein the compliant portion has a structure that provides it with compliant properties.

48. A patient interface according to any one of claims 33 to 47, wherein the seal member includes an overhanging portion extending from the compliant portion.

49. 49. A patient interface according to claim 48, wherein the seal member overhang portion extends in a radially inward direction from the compliant portion.

50. 50. A patient interface according to claim 48 or 49, wherein an overhanging portion of the seal member provides a pressure assisted seal.

51. A patient interface according to any one of claims 33 to 50, wherein the seal member includes at least one seal-enhancing feature on a rearward-facing surface thereof.

52. 52. A patient interface according to claim 51, wherein the seal enhancing feature increases the adhesiveness of a fabric seal.

53. 53. A patient interface according to claim 51 or 52, wherein the seal-enhancing feature comprises a layer of seal-enhancing material.

54. A patient interface according to any one of claims 51 to 53, wherein the seal-enhancing feature comprises discontinuously applied seal-enhancing material.

55. 55. A patient interface according to claim 53 or 54, wherein the seal enhancing material is one or more of polyurethane and silicone.

56. A patient interface according to any one of claims 51 to 55, wherein the seal-enhancing features are provided in selected area(s) along the length of the fabric seal.

57. A patient interface according to any one of claims 51 to 55, wherein the seal-enhancing features are provided to a greater extent in selected areas than in one or more other areas.

58. 58. A patient interface according to claim 57, wherein the seal-enhancing features are provided to a greater extent in an area that, in use, contacts the nose or nose bridge area or over the bridge of the nose area of ​​the patient's face.

59. A patient interface according to any one of claims 51 to 55, wherein the seal enhancing feature is provided along the entire length of the seal member.

60. 60. A patient interface according to any one of claims 33 to 59, further comprising a positioning and stabilising structure, said positioning and stabilising structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

61. 61. A patient interface according to claim 60, wherein the positioning and stabilising structure is provided on the frame.

62. 62. A patient interface according to claim 61, wherein the positioning and stabilising structure is sewn, bonded or integrally formed with the frame.

63. A patient interface according to any one of claims 60 to 62, wherein at least some of the positioning and stabilising structures are resilient.

64. 64. A patient interface according to any one of claims 33 to 63, further comprising at least one conduit configured to deliver a flow of air at therapeutic pressure to the plenum chamber for breathing by the patient.

65. 65. A patient interface according to claim 64, wherein at least one of the conduits is provided at an intermediate and lower position on the frame.

66. 65. A patient interface according to claim 64, wherein the at least one conduit includes a first conduit and a second conduit, each of the first conduit and second conduit routed along a lateral side of the patient's head between a corresponding one of the patient's eyes and ears.

67. A patient interface according to claim 66 when dependent on any one of claims 60 to 63, wherein the first conduit and the second conduit form part of a positioning and stabilising structure.

68. 68. A patient interface according to any one of claims 33 to 67, further comprising a vent structure for allowing a continuous flow of gases exhaled by a patient from within the plenum chamber to the surroundings, the vent structure being sized and shaped to maintain a therapeutic pressure within the plenum chamber in use.

69. 69. A patient interface according to claim 68, wherein the vent structure includes vent holes in the flexible material of the frame.

70. 69. A patient interface according to claim 68, wherein the vent structure includes a vent hole in a rigid insert provided in the frame.

71. 69. A patient interface according to claim 68, wherein the vent structure comprises an air permeable portion of the frame.

72. 69. A patient interface according to claim 68, wherein the vent structure is provided in a connection port provided in the frame.

73. A patient interface according to any one of claims 33 to 72, wherein the sealing member, in use, contacts the bridge of the patient's nose and the patient's chin.

74. 74. A patient interface according to claim 73, wherein the sealing member is configured to be positioned near the patient's nasal tip and adjacent the patient's lateral and / or alar cartilages in use.

75. 75. A patient interface according to claim 73 or 74, wherein the uppermost point of the seal member is configured to be substantially aligned with Frankfurt horizontal of the patient in use.

76. A patient interface according to any one of claims 33 to 75, wherein the sealing member defines a perimeter and the patient's nasolabial fold is configured to be located within the perimeter in use.

77. A patient interface comprising: Frame with at least 6 cmH above ambient air pressure ２ a frame formed at least in part from a fabric, the frame partially defining a plenum chamber pressurizable to a therapeutic pressure of O; a seal-forming structure constructed and arranged to form a seal against an area of ​​a patient's face surrounding an entrance to the patient's airways, said seal-forming structure having holes therein whereby a flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, said seal-forming structure constructed and arranged to maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle, said seal-forming structure including a fabric sealing member adapted for sealing engagement with the patient's face in use; a positioning and stabilizing structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure being formed at least in part from a textile, the positioning and stabilizing structure including an upper strap; at least one conduit configured to deliver a flow of air at a therapeutic pressure to the plenum chamber for breathing by the patient; the frame, the seal-forming structure, the positioning and stabilizing structure, and the at least one conduit are connected together via a one-piece woven structure; A patient interface, wherein at least one of the conduits is superimposed on the upper strap.

78. 78. A patient interface according to claim 77, wherein the seal-forming structure is configured to form a seal around only the patient's nares or around the patient's nares and the patient's mouth.

79. A patient interface according to any one of claims 77 to 78, wherein the positioning and stabilising structure defines at least a portion of at least one of the conduits.

80. 80. A patient interface according to any one of claims 77 to 79, wherein the at least one conduit includes a first conduit and a second conduit, each of the first conduit and second conduit routed along a lateral side of the patient's head between a corresponding one of the patient's eyes and ears.

81. A patient interface according to any one of claims 77 to 80, wherein at least one of the conduits is translationally fixed relative to the positioning and stabilising structure.

82. 82. A patient interface according to any one of claims 77 to 81, wherein at least one of the conduits includes at least one nasal opening configured to seal around the patient's nostril edges.

83. 83. A patient interface according to claim 82, wherein at least one of the conduits further comprises an oral opening configured to deliver pressurized air to the patient's mouth.

84. 84. A patient interface according to any one of claims 77 to 83, further comprising a stiffening portion at least partially disposed on a forward facing surface of the frame and connected to the frame via a one-piece construction.

85. 85. A patient interface according to claim 84, wherein the stiffening portion is constructed from a different material than the frame.

86. The stiffness imparting portion is an upper portion extending along the upper strap of the positioning and stabilizing structure; a lower portion extending along the lower strap of the positioning and stabilizing structure; 86. A patient interface according to claim 84 or 85, wherein the upper and lower portions are connected to the positioning and stabilising structure via a one-piece structure.

87. 87. A patient interface according to claim 86, wherein the upper and lower portions extend laterally further than at least one of the conduits.

88. 88. A patient interface according to claim 87, wherein the upper and lower portions extend substantially the same distance from the patient's head.

89. A patient interface according to any one of claims 84 to 87, wherein the stiffening portion is constructed from foam.

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