Elastomeric seal-forming structure with multiple curvatures

Abstract

To provide a medical device for use in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders having one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.SOLUTION: The patient interface may comprise a seal-forming structure comprising an elastomeric membrane with holes such that the flow of air is delivered to the entrance of the patient's nares / mouth at therapeutic pressures. The seal-forming structure is arranged to maintain a treatment pressure within the cavity of the plenum chamber throughout the patient's respiratory cycle in use. The elastomeric membrane includes a first portion held in a relaxed state and a second portion held in a tensioned state. The elastomeric membrane is molded to include a three dimensional shape having a plurality of curvatures. The hole includes arches on its lateral sides and is in a relaxed state prior to use. The arch portion is configured to be substantially taut during use.SELECTED DRAWING: Figure 60

Description

[Technical Field]

[0001] 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.

[0002] 1 Cross-reference to related applications This application claims priority to International Patent Application No. PCT / AU2020 / 051109, filed October 15, 2020, which claims priority to Australian Provisional Application No. 2020902371, filed July 9, 2020, and to U.S. Patent Application No. 16 / 850,803, filed April 16, 2020, which is a continuation-in-part of International Patent Application No. PCT / IB2019 / 058832, filed October 16, 2019, all of which are incorporated by reference in their entireties herein. [Background technology]

[0003] 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.

[0004] 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 oral cavity form the entrance to a patient's airways.

[0005] 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.

[0006] There is a range of respiratory diseases. Particular diseases can be characterized by particular manifestations such as apnea, hypopnea and hyperpnea.

[0007] 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.

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes of upper airway closure or obstruction during sleep. It results from an abnormally small upper airway combined with a normal loss of muscle tone in the tongue, soft palate, and posterior oropharyngeal wall region 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. Pat. No. 4,944,310 (Sullivan).

[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 disorders:

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

[0011] 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.

[0012] 2.2.2 Therapy A variety of respiratory therapies (e.g., continuous positive airway pressure (CPAP) therapy, noninvasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) are used to treat one or more of the above-mentioned respiratory disorders.

[0013] 2.2.2.1 Respiratory Pressure Therapy Respiratory pressure therapy is the application of a supply of air to the entrance of the airways at a controlled target pressure, usually a positive pressure relative to the atmosphere, throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as a tank ventilator or cuirass).

[0014] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that CPAP therapy 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.

[0015] 2.2.2.2 Flow Therapy Not all respiratory therapies are intended to deliver a prescribed therapeutic pressure. Some respiratory therapies aim to deliver a prescribed tidal volume by delivering an inspiratory flow profile (perhaps superimposed on a positive baseline pressure) for a targeted duration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy with a flow of conditioned or concentrated gas may be used only to support the patient's spontaneous breathing. In one example, high-flow therapy (HFT) involves providing a continuous, heated, humidified airflow through an unsealed or open patient interface to the airway entrance at a "therapeutic flow" that remains nearly constant throughout the respiratory cycle. The therapeutic flow is nominally set to exceed the patient's peak inspiratory flow. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that providing a high flow of air to the airway entrance improves ventilation efficiency by allowing exhaled CO2 to be flushed or swept away from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as dead space therapy (DST). Other benefits may include improved warmth and humidification (possibly through the benefit of secretory control) and a gradual increase in airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate may follow a profile that varies over the respiratory cycle.

[0016] Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy, in which a physician may prescribe a continuous flow of oxygen-enriched air at a specified oxygen concentration (between 21% and 100% of the oxygen fraction in ambient air) to be delivered to a patient's airways at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, or 3 LPM).

[0017] 2.2.2.3 Supplemental oxygen For certain patients, a combination of oxygen therapy and respiratory pressure therapy or HFT can be achieved by adding supplemental oxygen to the pressurized air stream. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplemental oxygen.

[0018] 2.2.3 Respiratory Treatment Systems These respiratory therapies may be provided by respiratory treatment systems or devices. Such systems and devices may also be used to screen, diagnose, or monitor disease without treating it.

[0019] The respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0020] 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 the gas supply to the airway at atmospheric pressure (e.g., at a positive pressure of approximately 10 cmH2O relative to atmospheric pressure) with sufficient dispersion for therapy to be performed. In other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of the gas supply to the airway at a positive pressure of approximately 10 cmH2O. For flow therapy, such as nasal HFT, the patient interface is configured to insufflate the nares (and specifically avoid a complete seal). One example of such a patient interface is a nasal cannula.

[0021] 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.

[0022] 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).

[0023] 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.

[0024] Certain masks may be impractical for use while sleeping (eg, when sleeping on one's side in bed with one's head resting on a pillow).

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0030] 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.

[0031] 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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 cause the mask to leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming portion can wrinkle or buckle during use, causing leakage.

[0036] 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.

[0037] 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.

[0038] 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).

[0039] 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.

[0040] 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 MIRAGE LIBERTY® Full Face Mask. Embodiments of nasal pillow masks are described in the following patent applications assigned to ResMed Limited: International Patent Application No. 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 Nos. 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 No. WO 2009 / 052,560 (which describes, among other things, aspects of ResMed Limited's SWIFT® FX Nasal Pillows).

[0041] 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.

[0042] One technique involves the use of adhesives, see, for example, U.S. Patent Application Publication No. US2010 / 0000534, but adhesives can be uncomfortable.

[0043] 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.

[0044] 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 therapies described above, for example, by activating the device to generate an air delivery flow to an interface with the airway. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). As such, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and mechanical ventilators.

[0045] 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., reliability, size, and weight requirements of medical devices). 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.

[0046] One example of a special requirement for a particular RPT device is acoustic noise.

[0047] 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]

[0048] 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.

[0049] The ResMed Elis Accent-Aiguée® 150 ventilator and ResMed VSIII® ventilator 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.

[0050] 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.

[0051] 2.2.3.3 Air Circuit An air circuit is a conduit or tube constructed and arranged so that, in use, airflow travels between two components of a respiratory therapy system (e.g., an RPT device and a patient interface). In some cases, there may be separate limbs of the air circuit for inspiration and expiration. In other cases, a single limb air circuit is used for both inspiration and expiration.

[0052] 2.2.3.4 Humidifier

[0053] 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.

[0054] A range of artificial humidification devices and systems are known, but do not meet the special requirements of medical humidifiers.

[0055] 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.

[0056] 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.

[0057] 2.2.3.5 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.

[0058] There may be other aspects of patient care that benefit from communication of treatment data to third parties or external systems.

[0059] Existing processes for communicating and managing such data can be costly, time consuming, and / or error prone.

[0060] 2.2.3.6 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 permanent 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.

[0061] In certain examples, 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 lower jaw or mandible, the upper and lower splints being laterally connected to each other via a pair of connecting rods that are fixed symmetrically on the upper and lower splints.

[0062] 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 then determined.

[0063] 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.

[0064] 2.2.3.7 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).

[0065] 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.

[0066] ResMed Limited has developed several improved mask ventilation technologies, see International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0067] Conventional mask noise table (ISO17510-2:2007, 10cmH2O pressure at 1m) [Table 2]

[0068] (*Measured using only one sample at 10cmH2O in CPAP mode using the test method specified in ISO3744)

[0069] The sound pressure values ​​of various objects are listed below [Table 3]

[0070] 2.2.4 Screening, diagnostic, and surveillance 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 patient to record various body signals (e.g., electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), and electromyography (EMG)). PSG for sleep-disordered breathing requires two nights of observation 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, diagnosis, and monitoring of sleep-disordered breathing are particularly unsuitable for home use.

[0071] 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. Some screening / diagnostic systems are adapted solely for screening / diagnosis, while some can also be used for monitoring.

[0072] 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 inexpensive. Different clinical experts may have different opinions about a patient's condition. Furthermore, a given clinical expert may apply different criteria at different times. Summary of the Invention [Means for solving the problem]

[0073] 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.

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

[0075] Another aspect of the present technology relates to methods used to screen for, diagnose, monitor, ameliorate, treat or prevent respiratory disorders.

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

[0077] One form of the present technology is a seal-forming structure for use with a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, the seal-forming structure comprising: The device has an elastomeric membrane connected to a flexible support structure in a relaxed state, with the bridge portions of the elastomeric membrane being held at a higher tension than the remainder of the elastomeric membrane.

[0078] One form of the present technology is a seal-forming structure for use with a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, the seal-forming structure comprising: The device has a woven membrane coupled to a flexible support structure in a relaxed state, with the bridge portions of the woven membrane held under higher tension than the remainder of the woven membrane.

[0079] One form of the present technology is a seal-forming structure for use with a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, the seal-forming structure comprising: Includes membranes cut from a sheet of material using ultrasonic cutting so that there is substantially no fraying around the periphery of the membrane, and constructed from woven and / or impermeable materials (e.g., silicone).

[0080] One form of the present technology is a seal-forming structure for use with a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, the seal-forming structure comprising: It includes a fabric layer that forms an air impermeable layer through which air can flow and that is configured to wick moisture away from the patient's skin.

[0081] One form of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrances to the patient's nares, configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to ameliorate sleep-disordered breathing, the patient interface including: a plenum chamber at least partially defining a cavity 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 the flow of air at the therapeutic pressure for breathing by the patient; and a seal-forming structure.

[0082] One form of the present technology includes a woven seal-forming structure with a bridge region between a first hole and a second hole, the bridge region being crimped such that it is held with a higher tension than the remainder of the woven membrane.

[0083] One form of the present technology includes an elastomeric seal-forming structure with a bridge region between the first hole and the second hole, the bridge region being crimped such that it is held with a higher tension than the remainder of the elastomeric membrane.

[0084] One form of the present technology includes a woven seal-forming structure with a bridge region between a first hole and a second hole, the bridge region being crimped such that it is held with a higher tension than the remainder of the woven membrane.

[0085] One form of the present technology includes an elastomeric seal-forming structure with a bridge region between a first hole and a second hole, the bridge region being substantially planar, and the bridge may be in tension greater than, less than, or equal to the remainder of the elastomeric membrane.

[0086] One form of the present technology is a seal-forming structure constructed from woven and / or elastomeric materials.

[0087] In some embodiments, a) the seal-forming structure is cut from the sheet of material using ultrasonic cutting; and / or b) the periphery of the seal-forming structure is configured to be substantially free of fraying due to the ultrasonic cutting.

[0088] In some embodiments, a) the seal-forming structure includes an air-impermeable layer; b) the air-impermeable layer is constructed from an elastomeric material; c) the seal-forming structure includes an air-permeable layer exposed around at least a portion of the periphery of the hole in the seal-forming structure; d) the air-permeable layer is configured to receive a portion of the air flow exiting the plenum chamber through at least one hole in the woven material; e) the first layer is configured to be disposed between the patient's skin and the air-impermeable layer; f) the air-permeable layer is configured to reflect the air flow between the patient's skin and the air-impermeable layer; and / or g) the air-permeable layer is configured to allow moisture wicking of the patient's skin due to air flow through the air-permeable layer.

[0089]

[0006] In accordance with another aspect of one form of the present technology, a seal-forming structure includes a woven membrane connected to a flexible support structure in a relaxed state, with bridge portions of the woven membrane held under higher tension than the remainder of the woven membrane.

[0090] A seal-forming structure according to another aspect of one form of the present technology includes an elastomeric membrane coupled to a flexible support structure in a relaxed state, with bridge portions of the elastomeric membrane held at a higher tension than the remainder of the elastomeric membrane.

[0091] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping, to improve sleep disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; A seal-forming structure, a textile membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway below a nasal bridge region of the patient's face, the textile membrane having a portion, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the cavity in use throughout the patient's respiratory cycle; where: The textile membrane is held in a relaxed state; The portion includes a seal-forming structure that is held at a higher tension than the remainder of the textile membrane.

[0092] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping, to improve sleep disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; A seal-forming structure, a seal-forming structure having an elastomeric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway below a nasal bridge region of the patient's face, said elastomeric membrane having a portion, said seal-forming structure constructed and arranged to maintain said therapeutic pressure within the cavity in use throughout the patient's respiratory cycle; where: The elastomeric membrane is held in a relaxed state; The portion includes a seal-forming structure that is held at a higher tension than the remainder of the elastomeric membrane.

[0093] In some embodiments, the elastomeric membrane has at least one hole or two holes formed therein such that a flow of air at said therapeutic pressure is delivered to at least the entrance to the patient's airways.

[0094] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping, to improve sleep disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; A seal-forming structure, a textile membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airways below a nasal bridge region of the patient's face, the textile membrane having at least one aperture such that airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the cavity in use throughout the patient's respiratory cycle; where: The woven membrane includes a first region held in a relaxed state and a second region held in a tensioned state, the tensioned state of the second region being configured such that the seal-forming structure includes a three-dimensional shape having multiple curvatures.

[0095] In some embodiments, a) a region of the first region is larger than a region of the second region; b) the at least one hole includes a first hole and a second hole, each configured to be positioned adjacent to one of the patient's nostrils in use, and a bridge region is positioned between the first hole and the second hole; c) the bridge region is the second region and is held in tension; d) the bridge region is crimped so as to be held at a higher tension than the first region of the textile membrane; e) the bridge region includes a first section and a second section, the first section is substantially flat and configured to contact the patient in use, and the second section extends into the plenum chamber; f) the bridge region is crimped using ultrasonic welding and / or adhesive; and / or g) ultrasonic welding and / or adhesive is applied to the second section.

[0096] In some embodiments, a) the seal-forming structure further comprises a flexible support structure for holding the woven membrane in a three-dimensional shape; b) the seal-forming structure comprises a single wall, and an end of the flexible support structure contacts the woven membrane; c) the seal-forming structure comprises a pair of walls, and the flexible support structure comprises a free end, and the woven membrane is connected to the flexible support structure distal to the free end, and the free end is spaced from the woven membrane such that the woven membrane is positioned radially outward of the free end; d) the flexible support structure is connected to the woven membrane by injection molding; and / or e) the bridge portion becomes a positioning spigot after being crimped.

[0097] In some embodiments, a) the woven membrane includes a first curvature about a first axis intersecting the first hole and the second hole, and prior to being crimped, the bridge region includes the bridge curvature in an opposite direction from the remainder of the woven membrane about the first axis; b) a second axis extends along the bridge region transverse to the first axis, and the woven membrane includes a quadratic curvature about the second axis; c) the quadratic curvature has one of a dome region and a saddle region, and the first curvature has the other of the dome region and the saddle region; d) the quadratic curvature is , configured to contact the patient's subnasal point in use; e) a third axis extends transverse to the second axis and is tilted relative to the first axis, the woven membrane comprising a third-order curvature about the third axis; f) the third-order curvature is configured to contact the patient's upper lip in use; g) a fourth axis extends transverse to the second axis to the third axis and is parallel to the first axis, the woven membrane comprising a fourth-order curvature about the fourth axis; h) the fourth-order curvature comprises a variable radius of curvature; and / or i) the fourth-order curvature extends into the first-order curvature near an edge of the woven membrane.

[0098] In some embodiments, a) a portion of the first hole distal to the bridge portion is movable between a first position and a second position; b) the first position is a natural state, and the textile membrane moves to the second position due to an external force; c) a portion of the first hole extends into the plenum chamber in the second position; d) the first hole comprises a generally teardrop shape in the second position; e) in the second position, the first hole is configured to contact a periphery of an entrance to one of the patient's nares adjacent to the nostril edge; and / or f) a portion of the second hole distal to the bridge portion is movable between the first position and the second position.

[0099] In some embodiments, a) the woven membrane comprises a woven layer and a silicone layer coupled to the woven layer, wherein the silicone layer is impermeable; b) the silicone layer has a thickness of approximately 0.5 mm; c) the silicone layer is disposed within the cavity and is configured not to contact the patient's skin during use; and / or d) the silicone layer has low durometer properties, and the woven membrane has high stretch capability when coupled to a flexible support structure.

[0100] In some embodiments, a) the length of the bridge region is directly related to the size of the first hole and the size of the second hole; b) the textile membrane is configured to curve about at least two non-parallel axes due to tension in the second region, thereby forming a three-dimensional shape; c) the textile membrane comprises a multilayer textile material and a silicone layer coupled to the multilayer textile material; d) the multilayer textile material comprises a first layer, a second layer, and a third layer, wherein the silicone layer contacts only the first layer and the third layer is configured to contact the patient's face in use; e) the first layer and the third layer are constructed of nylon and the second layer is constructed of spandex; f) the thickness of the textile membrane is approximately 0.35 mm to approximately 0.45 mm; and / or g) the patient's nose and upper lip are configured to contact only the textile membrane in use.

[0101] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping, to improve sleep disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; A seal-forming structure, an elastomeric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway below a nasal bridge region of the patient's face, the elastomeric membrane having at least one aperture such that airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the cavity in use throughout the patient's respiratory cycle; where: and a seal-forming structure, wherein the elastomeric membrane includes a first portion that is maintained in a relaxed state and a second portion that is maintained in a tensioned state, the tensioned state of the second portion being configured such that the seal-forming structure includes a three-dimensional shape having multiple curvatures.

[0102] In some embodiments, a) the area of ​​the first region is larger than the area of ​​the second region; b) the at least one hole comprises a first hole and a second hole, each configured to be positioned adjacent one of the patient's nostrils in use, and the bridge region is positioned between the first hole and the second hole; c) the bridge region is the second region and is held in tension; and / or d) the bridge region comprises a first section and a second section, the first section being substantially flat and configured to contact the patient in use, and the second section extending into the plenum chamber.

[0103] In some embodiments, a) the seal-forming structure further comprises a flexible support structure; b) the seal-forming structure comprises a single wall, and an end of the flexible support structure contacts the elastomeric membrane; c) the seal-forming structure comprises a pair of walls, and the flexible support structure comprises a free end, and the elastomeric membrane is coupled to the flexible support structure distal to the free end, and the free end is spaced from the elastomeric membrane such that the elastomeric membrane is positioned radially outward from the free end; and / or d) the flexible support structure is coupled to the elastomeric membrane by injection molding.

[0104] In some embodiments, a) the elastomeric membrane includes a first curvature about a first axis that intersects the first hole and the second hole; b) the second axis extends along the bridge portion transverse to the first axis, and the elastomeric membrane includes a secondary curvature about the second axis; c) the secondary curvature has one of a dome region and a saddle region, and the first curvature has the other of the dome region and the saddle region; d) the secondary curvature is configured to contact a subnasal point of the patient in use; e) the third curvature has a dome region and a saddle region; a) extending transversely to the second axis and tilted relative to the first axis, the elastomeric membrane including a third-order curvature about the third axis; b) the third-order curvature configured to contact the patient's upper lip in use; c) the fourth axis extending transversely to the second axis and parallel to the first axis, the elastomeric membrane including a fourth-order curvature about the fourth axis; d) the fourth axis extending transversely to the second axis and parallel to the first axis, the elastomeric membrane including a fourth-order curvature about the fourth axis; h) the fourth-order curvature including a variable radius of curvature; and / or i) the fourth-order curvature extends into the first-order curvature near the edge of the elastomeric membrane.

[0105] In some embodiments, a) a portion of the first hole distal to the bridge portion is movable between a first position and a second position; b) the first position is a natural state, and the elastomeric membrane moves to the second position due to an external force; c) a portion of the first hole extends into the plenum chamber in the second position; d) the first hole comprises a generally teardrop shape in the second position; e) in the second position, the first hole is configured to contact a periphery of an entrance to one of the patient's nares adjacent to the nostril edge; and / or f) a portion of the second hole distal to the bridge portion is movable between the first position and the second position.

[0106] In some embodiments, a) the elastomeric membrane comprises an impermeable silicone layer; b) the silicone layer has a thickness of (between) about (or approximately) 0.25 mm to about (or approximately) 0.3 mm; c) the silicone layer has low durometer properties; d) the silicone layer has a durometer hardness of 40 Shore A; e) the silicone layer is molded from a lower durometer silicone (e.g., 20 Shore A); f) the elastomeric membrane comprises a crimp for selectively applying localized tension; and / or g) the elastomeric membrane comprises a textile layer coupled to the silicone layer.

[0107] In some embodiments, a) the length of the bridge region is directly related to the size of the first hole and the size of the second hole; and / or b) the elastomeric membrane is configured to curve about at least two non-parallel axes due to the tension in the second region to form a three-dimensional shape.

[0108] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping, to improve sleep disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; A seal-forming structure, a textile membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airways below a nasal bridge region of the patient's face, the textile membrane having first and second holes with a bridge region disposed between the first and second holes, the first and second holes formed therein such that airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle in use; a flexible support structure for holding the textile membrane in a predefined shape; where: the textile membrane is coupled to a flexible support structure in a relaxed state; The bridge region includes a seal-forming structure that is crimped so that it is held at a higher tension than the remainder of the textile membrane.

[0109] In some embodiments, a) the woven membrane is configured to include being curved around at least two non-parallel axes due to a crimped bridge region; b) the bridge region is crimped using ultrasonic welding and / or adhesive; c) the length of the bridge region is directly related to the size of the first hole and the size of the second hole; d) the bridge region includes a first section and a second section; e) the first section is substantially flat and configured to contact the patient in use, and the second section extends into the plenum chamber; and / or f) ultrasonic welding and / or adhesive is applied to the second section.

[0110] In some embodiments, a) the seal-forming structure comprises a single wall; b) an end of the flexible support structure contacts the woven membrane; c) the seal-forming structure comprises a pair of walls; d) the flexible support structure comprises a free end; e) the woven membrane is connected to the flexible support structure distal to the free end; f) the free end is spaced from the woven membrane such that the woven membrane is positioned radially outward of the free end; g) the flexible support structure is connected to the woven membrane by injection molding; and / or h) the bridge portion becomes a positioning spigot after being crimped.

[0111] In some embodiments, a) the woven membrane comprises a woven layer and a silicone layer coupled to the woven layer; b) the silicone layer is impermeable; c) the silicone layer has a thickness of (between) about (or approximately) 20 microns to about (or approximately) 100 microns; d) the woven membrane comprises a multi-layer woven material and a silicone layer coupled to the multi-layer woven material; e) the multi-layer woven material comprises a first layer, a second layer, and a third layer, wherein the silicone layer contacts only the first layer and the third layer is configured to contact the patient's face during use; f) the first layer and the third layer are constructed of nylon and the second layer is constructed of spandex; and / or g) the silicone layer is disposed within the cavity and is configured not to contact the patient's skin during use.

[0112] In some embodiments, a) the silicone layer has low durometer properties; b) the woven membrane comprises high stretch capability when coupled to a flexible support structure; and / or c) the thickness of the woven membrane is approximately 0.6 mm to approximately 0.8 mm.

[0113] In some embodiments, a) the woven membrane includes a first curvature about a first axis intersecting the first opening and the second opening; b) prior to crimping, the bridge region includes a bridge curvature about the first axis in an opposite direction from the remainder of the woven membrane; c) a second axis extends along the bridge region transverse to the first axis; d) the woven membrane includes a secondary curvature about the second axis; e) the secondary curvature has a concavity opposite to the first curvature; and f) the secondary curvature contacts the patient's subnasal point in use. g) the third axis extends transverse to the second axis and is tilted relative to the first axis; h) the woven membrane includes a third order curvature about the third axis; i) the third order curvature is configured to contact the patient's upper lip in use; j) the fourth axis extends transverse to the second axis to the third axis and is parallel to the first axis; k) the woven membrane includes a fourth order curvature about the fourth axis; l) the fourth order curvature includes a variable radius of curvature; and / or m) the fourth order curvature extends into the first order curvature near an edge of the woven membrane.

[0114] In some embodiments, a) a portion of the first hole distal to the bridge portion is movable between a first position and a second position; b) the first position is a natural state, and the woven membrane moves to the second position due to an external force; c) a portion of the first hole extends into the plenum chamber in the second position; d) the first hole comprises a generally teardrop shape in the second position; e) in the second position, the first hole is configured to contact a periphery of an entrance to one of the patient's nares adjacent to the nostril edge; f) a portion of the second hole distal to the bridge portion is movable between the first position and the second position; g) the patient's nose and upper lip are configured to contact only the woven membrane in use; and / or h) the patient interface is a nasal cushion, a nasal cradle, an oral-nasal cushion, a mini full face mask, or a full face mask.

[0115] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping, to improve sleep disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; A seal-forming structure, an elastomeric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airways below a nasal bridge region of the patient's face, the elastomeric membrane having first and second holes with a bridge region disposed between the first and second holes, the first and second holes formed therein such that an airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle in use; a flexible support structure for holding the textile membrane in a predefined shape; where: the elastomeric membrane is molded into a flexible support structure in a relaxed state; The bridge region includes a seal-forming structure that is molded at a higher tension than the remainder of the elastomeric membrane.

[0116] Another aspect of the present technology is a patient interface for delivering a flow of air at a continuous positive pressure relative to ambient air pressure to the entrance of a patient's nares and to the entrance of the patient's mouth in a sealed manner, the patient interface configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to ameliorate sleep disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; 1. A seal-forming structure including an elastomeric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​a patient's face surrounding an entrance to the patient's nostrils and an entrance to the patient's mouth, said seal-forming structure comprising: a nasal region configured to at least partially surround an entrance to the patient's nostrils; and a mouth region configured to at least partially surround an entrance to the patient's mouth; the elastomeric membrane having at least one hole such that airflow at said therapeutic pressure is delivered to at least an entrance to the patient's nostrils and / or to an entrance to the patient's mouth, and the seal-forming structure has an elastomeric membrane constructed and arranged to maintain said therapeutic pressure within the cavity in use throughout the patient's respiratory cycle; The elastomeric membrane includes a first region that is held in a relaxed state and a second region that is held in a tensioned state, the tensioned state of the second region including a seal-forming structure configured such that the seal-forming structure includes a three-dimensional shape having multiple curvatures.

[0117] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; A seal-forming structure, an elastomeric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway below a nasal bridge region of the patient's face, the elastomeric membrane having at least one aperture such that airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the cavity in use throughout the patient's respiratory cycle; the elastomeric membrane includes a three-dimensional shape having multiple curvatures; The at least one hole includes an arch portion on a lateral side of the at least one hole, the arch portion being in a relaxed state prior to use, and the arch portion including a seal-forming structure configured to be in a substantially tensed state during use.

[0118] In some embodiments, a) the elastomeric membrane comprises a first layer and a second layer connected to the first layer; b) the first layer is adhesively connected to the second layer; c) the first layer is substantially uniform and the second layer is formed from a non-uniform matrix structure configured to render the elastomeric membrane anisotropic; and / or d) the second layer is formed from a plurality of spaced apart spherical or cylindrical structures.

[0119] In some embodiments, a) at least one opening is partially positioned in a common plane with the bridge portion configured to contact the patient's nose bridge region; and b) at least one opening is partially positioned completely out of plane with the bridge portion configured to contact the patient's nose bridge region.

[0120] In some embodiments, a) the at least one aperture portion includes a nostril opening configured to be positioned adjacent a nostril of the patient and a mouth portion opening configured to be positioned adjacent a mouth of the patient in use; b) the bridge portion extends across the nostril opening and divides the nostril opening into a first aperture portion and a second aperture portion, each of the first aperture portion and the second aperture portion configured to be positioned adjacent one of the patient's nostrils in use; and / or c) the bridge portion is the second portion and is held in tension.

[0121] In some embodiments, a) the first region at least partially comprises the mouth region; b) the first region comprises sections of the mouth region and the nose region; c) the seal-forming structure further comprises a flexible support structure for holding the elastomeric membrane in a three-dimensional shape; d) the flexible support structure comprises at least one support rib that engages with the mouth region within the cavity of the plenum chamber; e) the flexible support structure further comprises a secondary rib disposed within the cavity, the support rib extending between the secondary rib and the mouth region; f) the mouth region is curved around at least two non-parallel axes; and / or h) the elastomeric membrane comprises an impermeable silicone layer.

[0122] In some embodiments, a) the seal-forming structure is constructed from an elastomeric membrane, the elastomeric membrane having a first subsection and a second subsection spaced apart from the first subsection; b) the seal-forming structure further includes a flexible support region constructed with a thickness greater than the elastomeric membrane, the flexible support region being disposed between the first and second subsections; c) the second subsection is disposed above the first subsection in use; d) the second subsection is disposed at least partially between ends of the first subsection; and e) the at least one hole portion includes a nostril opening configured to be disposed adjacent to a patient's nostril and a hole opening configured to be disposed adjacent to a patient's mouth. and a mouth-site opening configured to completely define a perimeter of the mouth-site opening, the first subsection completely defining the perimeter of the mouth-site opening; the second subsection completely defining the perimeter of the nostril opening; f) the at least one opening portion includes a nostril opening configured to be positioned adjacent a patient's nostril and a mouth-site opening configured to be positioned adjacent a patient's mouth, the perimeter of the nostril opening being defined by the second subsection; the perimeter of the mouth-site opening being at least partially defined by a combination of the first subsection and the second subsection; g) the first subsection forms at least a portion of the mouth site and includes an annular shape; and / or h) the second subsection forms at least a portion of the mouth site and includes a U-shaped shape.

[0123] In some embodiments, a) the length of the bridge portion is directly related to the size of the first hole and the size of the second hole; b) the seal-forming structure includes a single wall; c) the end of the flexible support structure contacts the elastomeric membrane; d) the seal-forming structure includes a pair of walls; e) the flexible support structure includes a free end, and the elastomeric membrane is connected to the flexible support structure distal to the free end; and / or f) the free end is spaced from the elastomeric woven membrane such that the elastomeric membrane is positioned radially outward of the free end.

[0124] In some embodiments, a) the flexible support structure is coupled to the elastomeric membrane by injection molding; and / or b) the thickness of the elastomeric membrane is (between) about (or approximately) 20 microns to about (approximately) 100 microns.

[0125] In some embodiments, a) the elastomeric membrane includes a first curvature about a first axis that intersects the first opening and the second opening; b) the second axis extends along the bridge portion transverse to the first axis; c) the elastomeric membrane includes a quadratic curvature about the second axis; d) the second axis is tilted relative to the first axis; e) the elastomeric membrane includes a quadratic curvature about the second axis; f) the quadratic curvature is configured to contact the patient's upper lip in use; g) a third axis extends transverse to the second axis and parallel to the first axis, and the elastomeric membrane includes a cubic curvature about the third axis; h) the cubic curvature includes a variable radius of curvature; and / or i) the cubic curvature extends into the primary curvature adjacent the edge of the elastomeric membrane.

[0126] In some embodiments, a) a portion of the first hole distal to the bridge portion is movable between a first position and a second position; b) the first position is a natural state, and the elastomeric membrane moves to the second position due to an external force; c) a portion of the first hole extends into the plenum chamber in the second position; d) the first hole includes a generally teardrop shape in the second position; e) in the second position, the first hole is configured to contact a periphery of an entrance to one of the patient's nares adjacent to the nostril margin; f) a portion of the second hole distal to the bridge portion is movable between the first position and the second position; g) the first hole is further movable to a third position due to an additional external force; and / or h) the substantially sharp corners of the teardrop-shaped first hole are expanded and rounded in the third position.

[0127] In some embodiments, the patient interface is a nasal cushion, a nasal cradle, an oral-nasal cushion, a miniature full face mask, or a full face mask.

[0128] In some embodiments, a) the at least one hole includes an arch portion on a lateral side of the at least one hole; b) the arch portion is a saddle region; c) the arch portion is in a relaxed state before use; d) the arch portion is configured to invert into the cavity after contacting the patient's nostril; e) the arch portion remains in a relaxed state after inverting into the cavity; f) the arch portion is teardrop-shaped after inverting into the cavity; g) corners of the teardrop shape expand into a rounded shape during use; and / or h) the rounded shape is substantially taut.

[0129] In some embodiments, a) the elastomeric membrane comprises a crimp for selectively applying localized tension; b) the elastomeric membrane comprises a woven layer coupled to a silicone layer; c) the woven layer is configured to be cut from a sheet of material using ultrasonic cutting; d) the woven layer is a breathable material and configured to allow airflow therethrough to contact the patient's skin and provide cooling and / or moisture absorption; e) the elastomeric membrane forming the periphery of the at least one hole forms a saddle-shaped region in a relaxed state; f) the elastomeric membrane forming the periphery of the at least one hole forms a saddle-shaped region in a tensioned state; and / or g) the orientation of the saddle-shaped region in the relaxed state is substantially the same as the orientation of the saddle-shaped region in the tensioned state.

[0130] In some forms, a) the elastomeric membrane forming the perimeter immediately adjacent the at least one hole forms a dome region or a saddle region in the non-use state of the patient interface; b) the elastomeric membrane forming the perimeter immediately adjacent the at least one hole forms a saddle region in the non-use state; c) the elastomeric membrane forming the perimeter immediately adjacent the at least one hole forms a dome region or a saddle region in the actuated state of the patient interface; d) the elastomeric membrane forming the perimeter of the at least one hole forms a saddle region in the actuated state; and / or e) the orientation of the saddle region in the non-use state is substantially the same as the orientation of the saddle region in the actuated state.

[0131] In some embodiments, a) the arch portion of the first hole is movable between a first position and a second position; b) the first position is a natural state; c) the elastomeric membrane moves to the second position due to an external force; d) the arch portion of the first hole extends into the plenum chamber at the second position; e) the first hole includes a generally teardrop shape at the second position; f) the arch portion of the first hole is further movable to a third position due to an additional external force; and g) the generally teardrop shape has an edge. the portion expands to a substantially rounded periphery in the third position; h) in the second position, the first hole portion is configured to contact a periphery of an entrance to one of the patient's nostrils adjacent the nostril edge; i) the arch portion of the second hole portion is movable between the first and second positions; j) the first hole portion includes a generally teardrop shape in the first position prior to contact with the patient's face; and / or k) the corners of the generally teardrop shape expand to a substantially rounded periphery in the second position during use.

[0132] In some embodiments, a) the elastomeric membrane includes an impermeable silicone layer; b) the elastomeric membrane includes a woven layer coupled to the silicone layer; c) the woven layer is configured to be cut from a sheet of material using ultrasonic cutting; d) the woven layer is configured to allow airflow therethrough to provide cooling and / or wicking to the patient; e) the silicone layer includes a first sublayer and a second sublayer; f) the first sublayer is substantially uniform and the second sublayer is non-uniform; and / or g) the second sublayer is formed of a plurality of spaced apart structures configured to provide anisotropic properties to the elastomeric membrane.

[0133] Some embodiments include a method of constructing a patient interface, the method comprising: providing a mold having a shape corresponding to the elastomeric membrane of any one of the above forms; introducing a liquid material into the mold to form a three-dimensional shape of the elastomeric membrane; and separating the mold.

[0134] In some embodiments, the method further includes applying a fabric layer to at least a portion of the elastomeric membrane after separating the molds.

[0135] In some embodiments, the method further includes providing a sheet of woven material and cutting the sheet of woven material into a shape corresponding to the elastomeric membrane using ultrasonic cutting to form the woven layer.

[0136] In some embodiments, the method further includes crimping bridge portions of the elastomeric membrane after applying the fabric layer to form the fabric layer into a three-dimensional shape that substantially corresponds to the shape of the elastomeric membrane.

[0137] In another aspect of the invention, there is provided a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure including an elastomeric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airways below a nasal bridge region of the patient's face, the elastomeric membrane having a first hole and a second hole with a bridge region disposed between the first hole and the second hole formed therein such that an airflow 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 within the cavity throughout the patient's respiratory cycle in use; where: an elastomeric membrane molded to the flexible support structure of the seal-forming structure in a predetermined curved shape, the elastomeric membrane including a first curvature about a first axis and a second curvature about a second axis generally transverse to the first axis, the first axis configured to be generally transverse to a sagittal plane of the patient's head such that the first curvature has an apex in a posterior direction, whereby the first curvature passes around the nasolabial fold of the patient's nose, and the second axis configured to be generally parallel to the sagittal plane such that the second curvature has an apex in a inferior direction, whereby the second curvature is a saddle-like region having a generally positive curvature relative to the patient's upper lip in use; the bridge portion has a third curvature opposite to the first curvature; the elastomeric membrane is molded into a flexible support structure in a relaxed state; In use, the elastomeric membrane is configured to be pressed against the patient's face such that the patient's nose is not received in the cavity; The elastomeric membrane is attached to a flexible support structure along the periphery of the woven fabric membrane, causing the woven fabric membrane to extend radially inward beyond the support structure.

[0138] In some embodiments, the elastomeric membrane is substantially impermeable to air

[0139] In some embodiments, the elastomeric membrane comprises an impermeable silicone layer and / or a TPE layer.

[0140] In some embodiments, the thickness of the silicone layer and / or the TPE layer is (between) about (or approximately) 0.25 mm to about (or approximately) 0.3 mm.

[0141] In some embodiments, the silicone layer and / or the TPE layer have low durometer properties.

[0142] In some embodiments, the seal-forming structure comprises a single wall and an end of the flexible support structure contacts the elastomeric membrane.

[0143] In some embodiments, the seal-forming structure includes a pair of walls, the flexible support structure includes a free end, and the elastomeric membrane is coupled to the flexible support structure distal to the free end, the free end being spaced apart from the elastomeric membrane such that the elastomeric membrane is positioned radially outward from the free end.

[0144] In some embodiments, the first cavity includes a first arcuate portion, the first arcuate portion generally having a first curvature, and the first arcuate portion is configured to be positioned within a first nostril of the patient.

[0145] In some embodiments, the first arcuate portion is configured to invert from the generally first curvature to a generally third curvature after being placed within the patient's first nostril, and the arcuate portion is configured to surround a periphery of an entrance to the first nostril.

[0146] In some embodiments, the second cavity includes a second arcuate portion, the second arcuate portion generally having a first curvature, and the second arcuate portion is configured to be positioned within a second nostril of the patient.

[0147] In some embodiments, the first hole comprises a generally circular shape and is configured to comprise a generally teardrop shape after contact with the patient's face.

[0148] In some embodiments, the flexible support is coupled to the elastomeric membrane by injection molding.

[0149] In some embodiments, the elastomeric membrane includes a fourth curvature about a fourth axis, the fourth curvature being generally a saddle-shaped region with a positive curvature relative to the patient's subnasal point in use, and the fourth axis generally transverse to the first axis and the second axis.

[0150] In some embodiments, the second curvature affected area is formed by a generally rectangular area encompassing the first hole and the second hole, the generally rectangular area having a generally tangent relationship to the first hole and the second hole, the generally tangent relationship limiting wrinkling in the elastomeric membrane.

[0151] In another aspect of the present technology, there is provided a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure including an elastomeric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airways below a nasal bridge region of the patient's face, the elastomeric membrane having a first hole and a second hole with a bridge portion disposed between the first hole and the second hole, the first hole and the second hole formed therein such that an airflow 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 within the cavity throughout the patient's respiratory cycle in use; where: an elastomeric membrane molded to the flexible support structure of the seal-forming structure in a predetermined curved shape, the elastomeric membrane including a first curvature about a first axis and a second curvature about a second axis generally transverse to the first axis, the first axis configured to be generally transverse to a sagittal plane of the patient's head such that the first curvature has an apex in a posterior direction, whereby the first curvature is a generally negative dome curvature relative to the patient's upper lip in use; and the second axis configured to be generally parallel to the sagittal plane such that the second curvature has an apex in a inferior direction, whereby the second curvature is a generally saddle-shaped region having a positive curvature relative to the patient's nasal tip in use; the bridge portion has a third curvature opposite to the first curvature; the elastomeric membrane is molded into a flexible support structure in a relaxed state; In use, the elastomeric membrane is configured to be pressed against the patient's face such that the patient's nose is not received in the cavity; The woven elastomeric membrane is attached to the flexible support structure along the periphery of the elastomeric membrane, causing the elastomeric membrane to extend radially inward beyond the support structure.

[0152] In some embodiments, the elastomeric membrane includes a fourth curvature about a fourth axis configured to be generally parallel to the first axis such that the fourth curvature includes an apex in the posterior direction, whereby the fourth curvature passes around the nasolabial fold of the patient's nose.

[0153] In some embodiments, the elastomeric membrane is substantially impermeable to air

[0154] In some embodiments, the elastomeric membrane comprises an impermeable silicone layer and / or a TPE layer.

[0155] In some embodiments, the thickness of the silicone layer and / or the TPE layer is (between) about (or approximately) 0.25 mm to about (or approximately) 0.3 mm.

[0156] In some embodiments, the silicone layer and / or the TPE layer have low durometer properties.

[0157] In some embodiments, the seal-forming structure comprises a single wall and an end of the flexible support structure contacts the elastomeric membrane.

[0158] In some embodiments, the seal-forming structure includes a pair of walls, the flexible support structure includes a free end, and the elastomeric membrane is coupled to the flexible support structure distal to the free end, the free end being spaced apart from the elastomeric membrane such that the elastomeric membrane is positioned radially outward from the free end.

[0159] In some embodiments, the first cavity includes a first arcuate portion, the first arcuate portion generally having a first curvature, and the first arcuate portion is configured to be positioned within a first nostril of the patient.

[0160] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping, to improve sleep disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; A seal-forming structure, a seal-forming structure having an elastomeric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airway below a nasal bridge region of the patient's face, said elastomeric membrane having a portion, said seal-forming structure constructed and arranged to maintain said therapeutic pressure within the cavity in use throughout the patient's respiratory cycle; Here, the elastomeric membrane is held in tension.

[0161] One form of the present technology involves a woven seal-forming structure with a bridge region between a first hole and a second hole, with the entire elastomeric seal-forming structure being held in tension.

[0162] Another aspect of one form of the present technology is a seal-forming structure that includes an elastomeric membrane coupled to a flexible support structure in a taut state, where a bridge portion of the elastomeric membrane substantially flattens due to the tension.

[0163] Another aspect of one form of the present technology is a seal-forming structure that includes an elastomeric membrane coupled to a flexible support structure in a taut state prior to use, the elastomeric membrane having a substantially flat surface in at least one direction in the taut state prior to use.

[0164] In another aspect of the invention, there is provided a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a woven fabric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airways below a nasal bridge region of the patient's face, the woven fabric membrane having first and second holes with a bridge region disposed between the first and second holes, the first and second holes formed therein such that an airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle in use; where: the seal-forming structure includes a flexible support structure for holding the textile membrane in a predetermined curved shape, the textile membrane having a first curvature about a first axis and a second curvature about a second axis generally transverse to the first axis, the first axis configured to be generally transverse to a sagittal plane of the patient's head such that the first curvature has an apex in a posterior direction, whereby the first curvature passes around the nasolabial fold of the patient's nose, and the second axis configured to be generally parallel to the sagittal plane such that the second curvature has an apex in a inferior direction, whereby the second curvature is a saddle-like region and has a generally positive curvature relative to the patient's upper lip in use; the bridge regions have a third curvature opposite the first curvature, the third curvature of the bridge regions limiting wrinkling along a surface of the textile membrane; the textile membrane is coupled to a flexible support structure in a relaxed state; In use, the textile membrane is configured to be pressed against the patient's face such that the patient's nose is not received in the cavity; The textile membrane is attached to a flexible support structure along the periphery of the textile membrane, thereby extending radially inward beyond the support structure.

[0165] In some embodiments, a) the bridge region is crimped to maintain the third curvature and limit overturning to the first curvature; and / or b) the bridge region is crimped using ultrasonic welding and / or adhesive.

[0166] In some embodiments, a) the woven membrane is substantially impermeable to air; b) the woven membrane comprises a woven layer and a silicone layer coupled to the woven layer, wherein the silicone layer is impermeable; c) the silicone layer has a thickness of (between) about (or approximately) 20 microns to about (or approximately) 100 microns; and / or d) the silicone layer is disposed within the cavity and is configured not to contact the patient's skin during use.

[0167] In some embodiments, a) the silicone layer has low durometer properties; b) the textile layer comprises high stretch capability when coupled to a support structure; and / or c) the thickness of the textile membrane is approximately 0.6 mm to approximately 0.8 mm.

[0168] In some embodiments, a) the seal-forming structure comprises a single wall; b) an end of the flexible support structure contacts the woven membrane; c) the seal-forming structure comprises a pair of walls; d) the flexible support structure comprises a free end, and the woven membrane is connected to the flexible support structure distal to the free end; and / or e) the free end is spaced from the woven membrane such that the woven membrane is positioned radially outward from the free end.

[0169] In some embodiments, a) the first hole comprises a first arch portion, the first arch portion having a generally first curvature, the first arch portion configured to be placed within a first nostril of the patient; b) the first arch portion is configured to invert from the generally first curvature to a generally third curvature after being placed within the first nostril of the patient; c) the arch portion is configured to surround a periphery of an entrance to the first nostril; d) the second hole comprises a second arch portion; e) the second arch portion has generally the first curvature; f) the second arch portion is configured to be placed within a second nostril of the patient; and / or g) the first hole comprises a generally circular shape and is configured to comprise a generally teardrop shape after contacting the patient's face.

[0170] In some embodiments, a) the woven membrane is configured to contact only the patient's upper lip, subnasal point, and nasal tip when in use; b) the flexible support is connected to the woven membrane by injection molding; c) the woven membrane includes a fourth curvature about a fourth axis; d) the fourth curvature is generally a saddle-shaped region with a positive curvature relative to the patient's subnasal point when in use; e) the fourth axis generally intersects the first axis and the second axis; f) the region affected by the second curvature is formed by a generally rectangular region that encompasses the first hole and the second hole; g) the generally rectangular region has a generally tangent relationship to the first hole and the second hole; and / or h) the generally tangent relationship limits wrinkling in the woven membrane.

[0171] In another aspect of the present technology, there is provided a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a woven fabric membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airways below a nasal bridge region of the patient's face, the woven fabric membrane having first and second holes with a bridge region disposed between the first and second holes, the first and second holes formed therein such that an airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle in use; where: the seal-forming structure includes a flexible support structure for holding the textile membrane in a predetermined curved shape, the textile membrane having a first curvature about a first axis and a second curvature about a second axis generally transverse to the first axis, the first axis being configured to be generally transverse to a sagittal plane of the patient's head such that the first curvature has an apex in a posterior direction, whereby the first curvature is a generally negative dome curvature relative to the patient's upper lip in use, and the second axis being configured to be generally parallel to the sagittal plane such that the second curvature is a generally saddle-shaped region and has a positive curvature relative to the patient's nasal tip in use; the bridge regions have a third curvature opposite the first curvature, the third curvature of the bridge regions limiting wrinkling along a surface of the textile membrane; the textile membrane is coupled to a flexible support structure in a relaxed state; In use, the textile membrane is configured to be pressed against the patient's face such that the patient's nose is not received in the cavity; The textile membrane is attached to a flexible support structure along the periphery of the textile membrane, thereby extending radially inward beyond the support structure.

[0172] In some embodiments, a) the woven membrane includes a fourth curvature about a quarter axis configured to be generally parallel to the first axis such that the fourth curvature includes a posterior apex, whereby the fourth curvature extends around the nasolabial fold of the patient's nose; b) the bridge region is crimped to maintain the third curvature and limit overturning to the first curvature; and / or c) the bridge region is crimped using ultrasonic welding and / or adhesive.

[0173] In some embodiments, a) the woven membrane is substantially impermeable to air; b) the woven membrane comprises a woven layer and a silicone layer coupled to the woven layer, wherein the silicone layer is impermeable; c) the silicone layer has a thickness of (between) about (or approximately) 20 microns to about (or approximately) 100 microns; and / or d) the silicone layer is disposed within the cavity and is configured not to contact the patient's skin during use.

[0174] In some embodiments, a) the silicone layer has low durometer properties; b) the woven layer comprises high stretch capability when coupled to the support structure; c) the thickness of the woven membrane is approximately 0.6 mm to approximately 0.8 mm; d) the seal-forming structure comprises a single wall, and an end of the flexible support structure contacts the woven membrane; e) the seal-forming structure comprises a pair of walls; f) the flexible support structure comprises a free end, and the woven membrane is coupled to the flexible support structure distal to the free end; and / or g) the free end is spaced from the woven membrane such that the woven membrane is positioned radially outward of the free end.

[0175] In some embodiments, a) the first cavity comprises a first arcuate portion; b) the first arcuate portion generally has a first curvature; and / or c) the first arcuate portion is configured to be placed within a first nostril of the patient.

[0176] In another aspect of the present technology, the seal-forming structure comprises: a textile membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airways below a nasal bridge region of the patient's face, the textile membrane having first and second holes with a bridge region disposed between the first and second holes, the first and second holes formed therein such that airflow at the therapeutic pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle in use; a flexible support structure for holding the textile membrane in a predefined shape; where: the textile membrane is coupled to a flexible support structure in a relaxed state; The bridge sections are crimped so that they are held at a higher tension than the rest of the textile membrane.

[0177] Another aspect of the present technology is a woven fabric membrane for use as a seal-forming structure in a patient interface configured to provide sealed delivery of airflow at a continuously positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nares, the patient interface configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping, to improve sleep-disordered breathing, the woven fabric membrane comprising: A textile material; an elastomeric material connected to the woven material, the elastomeric material forming an air impermeable layer; Here, at least the periphery of the woven material is formed using ultrasonic cutting.

[0178] Another aspect of the present technology is a woven fabric membrane for use as a seal-forming structure in a patient interface configured to provide sealed delivery of airflow at a continuously positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nares, the patient interface configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping, to improve sleep-disordered breathing, the woven fabric membrane comprising: a textile material configured to contact the patient's skin; an elastomeric material connected to the woven material, the elastomeric material configured to form a surface of the pressurized volume of the patient interface; Here, the elastomeric material is configured to be an air impermeable layer, and the woven material is configured to allow airflow therethrough.

[0179] Another aspect of the present technology is a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrance to the patient's nostrils, configured to maintain a therapeutic pressure in use in a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle while the patient is sleeping to improve sleep-disordered breathing, the patient interface comprising: a plenum chamber at least partially defining a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; A seal-forming structure, a textile membrane constructed and arranged to form a pressure-assisted seal with an area of ​​the patient's face surrounding an entrance to the patient's airways below a nasal bridge region of the patient's face, the textile membrane having at least one aperture such that airflow 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 within the cavity in use throughout the patient's respiratory cycle, the textile membrane comprising: a first layer constructed from a textile material and configured to contact the patient's face; and a second layer connected to the first layer, the second layer being constructed from an elastomeric material and forming a wall of the cavity; wherein the textile membrane includes a seal-forming structure including a three-dimensional shape having multiple curvatures; wherein the elastomeric material of the second layer is configured to block air flow; The fabric material is configured to allow air flow therethrough to provide a cooling effect to the patient's skin in contact with the first layer.

[0180] In some embodiments, a) at least the woven material of the woven membrane is cut from the sheet of material using ultrasonic cutting; b) the entire woven membrane is cut from the sheet of material using ultrasonic cutting; and / or c) the peripheral edge of the first layer is configured to be substantially free of fraying due to the ultrasonic cutting.

[0181] In some embodiments, a) the second layer is an air-impermeable layer; b) the first layer is an air-permeable layer; c) the first layer is exposed around at least a portion of the periphery of at least one hole in the woven membrane; d) the first layer is configured to receive a portion of the air flow exiting the plenum chamber through the at least one hole in the woven membrane; e) the first layer is configured to be positioned between the patient's skin and the second layer; f) the first layer is configured to bounce the air flow between the patient's skin and the second layer; and / or g) the first layer is configured to allow moisture wicking of the patient's skin due to the air flow through the first layer.

[0182] In some embodiments, a) the thickness of the second layer is between about (or approximately) 20 microns and about (or approximately) 100 microns; b) the thickness of the first layer is between about (or approximately) 0.6 mm and about (or approximately) 0.8 mm; c) the woven membrane comprises a first region held in a relaxed state and a second region held in a tensioned state; d) the tensioned state of the second region is configured such that the seal-forming structure comprises a three-dimensional shape having multiple curvatures; e) the second region is a bridge region formed between a first hole and a second hole of the at least one hole in the elastomeric membrane; and / or f) the bridge region is crimped.

[0183] In some embodiments, a) the at least one hole includes an arch portion on a lateral side of the at least one hole; b) the arch portion is in a relaxed state prior to use; c) the arch portion is configured to move to a substantially taut state during use; and / or d) the patient interface is a nasal cushion, a nasal cradle, an oral-nasal cushion, a mini full face mask, or a full face mask.

[0184] In some embodiments, a) the second layer comprises a first sublayer and a second sublayer coupled to the first sublayer; b) the first sublayer is coupled to the second sublayer with an adhesive; c) the first sublayer is substantially uniform and the second sublayer is formed from a non-uniform matrix structure configured to render the elastomeric material anisotropic; and / or d) the second sublayer is formed from a plurality of spaced apart spherical or cylindrical structures.

[0185] In some embodiments, a) the thickness of the first sublayer is between about (or approximately) 0.01 mm and about (or approximately) 0.05 mm; b) the thickness of the second sublayer is approximately equal to the thickness of the first sublayer; c) the thickness of the second sublayer is less than the thickness of the first sublayer; d) the porosity of the first sublayer is between about (or approximately) 30 gsm and about (or approximately) 50 gsm; and / or e) the porosity of the second sublayer is less than the porosity of the first sublayer.

[0186] 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.

[0187] One aspect of the present technology is a method for manufacturing a device.

[0188] 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.

[0189] 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).

[0190] One 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.One aspect of one form of the present technology is a humidification tank that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0191] One aspect of one form of the present technology is a method of constructing a patient interface, the method including providing a mold having a three-dimensional shape, introducing a liquid material into the mold to form an elastomeric membrane having the three-dimensional shape, and separating the molds.

[0192] Some embodiments further include applying a fabric layer to at least a portion of the elastomeric membrane after separating the molds.

[0193] Some embodiments further include crimping the bridge portions of the elastomeric membrane after applying the fabric layer to form a three-dimensionally shaped fabric layer that substantially corresponds to the shape of the elastomeric membrane.

[0194] The described methods, systems, devices, and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor of 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).

[0195] 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.

[0196] Other features of the present technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawings]

[0197] 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: 4.1 Respiratory Treatment Systems

[0198] [Figure 1A] A system is shown including a patient 1000 wearing a patient interface 3000, which 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] 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 diagram of the plenum chamber 3200 showing the sagittal and medial contact planes. [Figure 3V]A posterior view of the plenum chamber of Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 3V, a sagittal plane bisects the plenum chamber into a left-hand side and a right-hand side. [Figure 3W] 3V is a cross-sectional view through the plenum chamber of FIG. 3V, where the cross-section is taken in the sagittal plane shown in FIG. 3V. The "central contact" plane is shown. The central contact plane is perpendicular to the sagittal plane. The orientation of the central contact plane corresponds to the orientation of the tendon 3210. The tendon 3210 rests on the sagittal plane and contacts only the cushion of the plenum chamber at two points on the sagittal plane (i.e., superior point 3220 and inferior point 3230). 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 sagittal plane of the plenum chamber 3200 generally coincides with the mid-sagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face plane" when the plenum chamber is in the use position. In Figure 3X, the plenum chamber 3200 is that of a nasal mask, with the upper point 3220 resting approximately on the selion and the lower point 3230 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] 4.5 Respiratory Waveforms [Figure 5] A model of a typical human breathing waveform during sleep is shown. 4.6 Patient interface using this technology [Figure 6]FIG. 10 is a perspective view of a patient interface according to an embodiment of the present technology as worn by a patient, illustrating force vectors when the patient is in an upright position; [Figure 6-1] FIG. 7 is a perspective view of the patient interface according to FIG. 6, showing force vectors when the patient is lying supine. [Figure 6-2] FIG. 7 is a perspective view of the patient interface according to FIG. 6, showing force vectors when the patient is lying on his or her side. [Figure 7] FIG. 10 is a perspective view of a patient interface according to another embodiment of the present technology as it is being worn by a patient; [Figure 8] FIG. 8 is a cross-sectional view of the positioning and stabilizing structure taken along line 8-8 of FIG. 7. [Figure 9] FIG. 9 is an enlarged view of a portion of the positioning and stabilizing structure of FIG. 8. [Figure 10] FIG. 9 is an enlarged view of a portion of the positioning and stabilizing structure of FIG. 8. [Figure 11] FIG. 7 is a front view of the cushion assembly of FIG. 6 positioned on a patient's face. [Figure 12] FIG. 10 is a front perspective view of a cushion assembly according to an embodiment of the present technology. [Figure 13] FIG. 13 is a front view of the cushion assembly of FIG. 12. [Figure 14] FIG. 13 is a top perspective view of the cushion assembly of FIG. 12. [Figure 15] FIG. 13 is a top view of the cushion assembly of FIG. 12. [Figure 16] FIG. 16 is a cross-sectional view taken along line 16-16 of FIG. [Figure 17] FIG. 17 is a cross-sectional view taken along line 17-17 of FIG. [Figure 18] 17 is an enlarged detail taken from FIG. 16. [Figure 19] FIG. 10 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane according to an example of the present technology. [Figure 20] FIG. 10 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane according to an example of the present technology. [Figure 21] FIG. 10 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane according to an example of the present technology. [Figure 22] FIG. 10 is a perspective view of a patient interface according to another embodiment of the present technology. [Figure 23] FIG. 23 is a perspective view of the patient interface of FIG. 22 as worn by a patient. [Figure 24] FIG. 24 is a side view of the patient interface of FIG. 23. [Figure 25] FIG. 24 is a front perspective view of the patient interface of FIG. 23. [Figure 26] FIG. 13 is a front view of a cushion assembly of a patient interface according to an embodiment of the present technology. [Figure 27] FIG. 27 is a top view of the cushion assembly of FIG. 26. [Figure 28] FIG. 27 is a bottom view of the cushion assembly of FIG. 26. [Figure 29] FIG. 27 is a front perspective view of the cushion assembly of FIG. 26. [Figure 30] FIG. 27 is a rear perspective view of the cushion assembly of FIG. 26. [Figure 31] FIG. 27 is a side perspective view of the cushion assembly of FIG. 26. [Figure 32] FIG. 27 is a front perspective view of the cushion assembly of FIG. 26 showing an inner portion of the cushion assembly. [Figure 33] FIG. 27 is a front view of the cushion assembly of FIG. 26 showing an inner portion of the cushion assembly. [Figure 33-1] FIG. 10 is a rear perspective view of a cushion assembly according to an embodiment of the present technology. [Figure 33-2] FIG. 10 is a rear perspective view of a cushion assembly according to an embodiment of the present technology. [Figure 33-3] FIG. 10 is a rear perspective view of a cushion assembly according to an embodiment of the present technology, where the closure is constructed from a single piece of woven material. [Figure 33-4]FIG. 33-4 is a rear perspective view of the cushion assembly of FIG. 33-3, illustrating how the sealing portion has a more positive dome curvature at the location configured to contact the patient's upper lip. [Figure 33-5] FIG. 33-5 is a top view of the cushion assembly of FIG. [Figure 33-6] FIG. 33-4 is a side perspective view of the cushion assembly of FIG. 33-3 showing the support ribs. [Figure 33-7] FIG. 33-3 is a side perspective view of the cushion assembly of FIG. 33-3, showing larger support ribs compared to FIG. 33-6. [Figure 33-8] FIG. 33-4 is a rear perspective view of the cushion assembly of FIG. 33-3 with a thicker corner nose region to provide a smaller space to accommodate the patient's nose. [Figure 33-9] FIG. 33-8 is a top view of the cushion assembly. [Figure 33-10] 33-3 is a front view of the cushion assembly of FIG. 33-3, showing the conduit connector portion elevated compared to the patient interface of FIG. 24. [Figure 33-11] FIG. 33-4 is a rear perspective view of the cushion assembly of FIG. 33-3, showing a foam insert configured to contact the corners of the patient's nasal region. [Figure 34] FIG. 23 is a rear view of a cushion assembly for use with the patient interface of FIG. 22. [Figure 35] FIG. 35 is a front view of the cushion assembly of FIG. 34. [Figure 36] FIG. 36 is a cross-sectional view of the cushion assembly of FIG. 34 taken along line 36-36. [Figure 37] FIG. 10 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane according to an example of the present technology. [Figure 38] FIG. 10 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane according to an example of the present technology. [Figure 39] FIG. 10 is a front perspective view of a cushion assembly with a grip pad disposed on a textile membrane according to an example of the present technology. [Figure 40]1 is a schematic diagram of a process for applying an air impermeable layer to a textile material, according to one embodiment of the present technology; [Figure 40-1] FIG. 10 is a schematic diagram of a process for applying an air impermeable layer to a textile material, according to another example of the present technology. [Figure 41] FIG. 1 is a schematic diagram of a patient's face being placed against a woven membrane with low tension before use. [Figure 42] FIG. 1 is a schematic diagram illustrating the force exerted by the textile membrane on the patient's face due to tensile stress in the textile membrane. [Figure 43] FIG. 10 is a schematic diagram of a tension force applied to a seal of a cushion assembly according to an embodiment of the present technology. [Figure 44] 1 is a schematic diagram illustrating the force exerted by the fabric membrane on the patient's face due to air pressure within the cavity formed by the cushion assembly. FIG. [Figure 45] 1 shows the knitting process. [Figure 46] 1 shows the knitting process. [Figure 47] 1 shows a warp knitted fabric according to one embodiment of the present technology. [Figure 48] 1 shows a weft knit fabric according to one embodiment of the present technology. [Figure 49] FIG. 1 is a perspective view of a woven material curved or folded about a first axis. [Figure 50] FIG. 50 is a perspective view of the woven material of FIG. 49 curved or folded about a first axis and a second axis, the second axis not being parallel to the first axis and causing the woven material to be curved or folded about the second axis to create wrinkles and / or creases. [Figure 51] 1 is a perspective view of a woven material for use as a seal-forming structure, the woven material being curved or folded about three non-parallel axes and processed to limit the formation of wrinkles and / or creases. [Figure 52] FIG. 50 is a perspective view of the woven material of FIG. 49 with a pair of openings cut into the material and a bridge region located between the two openings. [Figure 53]53 is a perspective view of the woven material of FIG. 52 with the bridge region inverted about a second axis and parallel to the first axis. FIG. [Figure 54] FIG. 54 is a perspective view of the woven material of FIG. 53 showing the bridge region under tension from the crimping process. [Figure 55] FIG. 54 is a perspective view of the woven material of FIG. 53 curved or folded about non-parallel axes. Curving or folding the bridge regions limits the occurrence of wrinkles and / or creases in the woven material. [Figure 56] 56 is a detailed view of the woven material of FIG. 55 showing curvature about different axes. [Figure 57a] Detail of the woven material showing the perimeter of the opening, which can vary depending on the length of the crimped bridge section. [Figure 57b] FIG. 10 is a detailed view of a woven material showing the perimeter of an opening according to another embodiment. [Figure 57-1a] 58 is a detailed view of the elastomeric material showing the perimeter of the opening. The elastomeric material may be molded to resemble the shape of the woven material of FIG. 57. [Figure 57-1b] FIG. 10 is a detailed view of the elastomeric material showing the perimeter of an opening according to another embodiment. [Figure 57-1c] FIG. 10 is a detailed view of the elastomeric material showing the perimeter of an opening according to another embodiment. [Figure 58] 55 is a cross-sectional view of a cushion assembly formed with the woven material of FIG. 54. A flexible support structure contacts the woven material to form a single wall portion. [Figure 58-1] FIG. 55 is a cross-sectional view of an alternative cushion assembly formed from the woven material of FIG. 54. The woven material includes an arcuate portion that partially surrounds the opening. [Figure 58-2] FIG. 58-2 is a cross-sectional view of the cushion assembly of FIG. 58-1 moved to an activated position. [Figure 59] FIG. 55 is a cross-sectional view of a cushion assembly formed from the woven material of FIG. 54, with a portion of the flexible support structure spaced apart from the woven material to form two walls. [Figure 60] FIG. 55 is a perspective view of a cushion assembly formed from the woven material of FIG. 54. The woven material includes an arcuate portion that partially surrounds an opening. [Figure 60-1] FIG. 61 is a side perspective view of the cushion assembly of FIG. 60 with the nostril openings oriented substantially vertically. [Figure 61] FIG. 61 is a perspective view of the cushion assembly of FIG. 60 with the arcuate portion inwardly inverted so that the opening comprises a generally teardrop shape. [Figure 61-1] FIG. 61 is a rear perspective view of the cushion assembly of FIG. 60 with the arches of both nostril openings inwardly inverted so that the openings comprise a generally teardrop shape. [Figure 61-2] FIG. 61 is a perspective view of the cushion assembly of FIG. 60, with the arcuate portion expanded from a teardrop shape to form a rounded periphery. [Figure 62] 57-2 is a perspective view of a cushion assembly formed from the elastomeric material of FIG. 57-1, the elastomeric material including an arcuate portion partially surrounding an opening. [Figure 62-1] FIG. 63 is a side perspective view of the cushion assembly of FIG. 62 with the nostril openings oriented substantially vertically. [Figure 63] FIG. 63 is a perspective view of the cushion assembly of FIG. 62 with the arcuate portion inwardly inverted so that the opening comprises a generally teardrop shape. [Figure 63-1] FIG. 61 is a rear perspective view of the cushion assembly of FIG. 60 with the arches of both nostril openings inwardly inverted so that the openings comprise a generally teardrop shape. [Figure 64] FIG. 64 is a perspective view of the cushion assembly of FIG. 63, in which the arcuate portion has been expanded from a teardrop shape to form a rounded periphery. [Figure 65] FIG. 64 is a perspective view of the cushion assembly of FIG. 63 in which the arches of both nostril openings have been expanded from a teardrop shape to form rounded peripheries. [Figure 66] FIG. 61 is a perspective view of a patient wearing the cushion assembly of FIG. 60, with the arch portion of the cushion assembly shown in a first position. [Figure 67]61 is a perspective view of a patient without the cushion assembly of FIG. 60, showing the arch portion in the second position before returning to the first position. [Figure 68] FIG. 61 is a perspective view of a patient wearing the cushion assembly of FIG. 60. [Figure 69] FIG. 63 is a schematic diagram of a mold for making the cushion assembly of FIG. 62. [Figure 70] 10 is a schematic cross-sectional view of a seal-forming structure according to another embodiment showing a multi-layer impermeable portion connected to a woven material. [Figure 70-1] 10 is a schematic cross-sectional view of a seal-forming structure according to another embodiment showing a multi-layer impermeable portion without a woven material. [Figure 71] FIG. 71 is a plan view of one layer of the multi-layer impermeable portion of FIG. 70. [Figure 72] FIG. 71 is a plan view of two layers of the multi-layer impermeable portion of FIG. 70. [Figure 73] 1 is a schematic illustration of a patient wearing a cushion assembly having breathable and / or absorbent fabric. DETAILED DESCRIPTION OF THE INVENTION

[0199] 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.

[0200] 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.

[0201] 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.

[0202] 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.

[0203] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.

[0204] 5.2 Respiratory Treatment Systems In one form, the present technology includes a respiratory treatment system for the treatment of respiratory disorders. The respiratory treatment system may include an RPT device 4000 that delivers airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0205] 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 an entrance to the patient's 1000 airway so as to maintain positive pressure at the entrance to the patient's 1000 airway. Thus, the sealed patient interface 3000 is suitable for delivery of positive pressure therapy.

[0206] 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.

[0207] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.

[0208] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.

[0209] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient.

[0210] 5.3.1 Seal formation structure In one form of the present technology, the seal-forming structure 3100 provides a target seal-forming area and may further provide a cushioning function. The target seal-forming area is the area where a seal may occur in the seal-forming structure 3100. The area where a seal actually occurs (i.e., the actual sealing surface) may vary from patient to patient in a given treatment session and from day to day, depending on a range of factors (e.g., placement of the patient interface on the face, tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0211] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0212] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0213] A seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material (eg, silicone).

[0214] In some embodiments, such as those shown in Figures 6-39, the seal-forming structures 3100, 6100, and 9100 have a seal comprising a woven material, which may cover all or part of the seal-forming structures 3100, 6100, and 9100. In some embodiments, the woven material may comprise a material formed by a fiber network and may be adapted to be impermeable to air. For example, the woven material may have an air-impermeable film on at least one surface thereof, thereby forming a woven membrane or woven seal.

[0215] While the following description relates to seal-forming structures constructed at least in part from woven fabric, the description is equally applicable to elastomeric-only (e.g., silicone, TPE, etc.) seal-forming structures. All of the shapes and properties of the woven seal-forming structures described below may be applicable to elastomeric-only seal-forming structures. Some similarities and differences may be specified in this description.

[0216] In some embodiments, the woven membrane can be constructed to be elastically stretchable in at least one dimension. For example, if the woven membrane is constructed from a fiber network, the woven membrane can be stretchable in the longitudinal direction (warp) and / or the transverse direction (weft) across the woven membrane. In some embodiments, the woven membrane is constructed to be elastically stretchable to a range beyond that achievable with conventional silicone seal-forming structures.

[0217] In some embodiments, the woven membrane is constructed to be substantially inelastic in at least one dimension. For example, if the woven membrane is constructed from a woven material, the woven membrane may be capable of substantially withstanding elongation in one or both of the longitudinal warp direction or the transverse weft direction across the woven membrane.

[0218] The woven membrane may include a single layer or multiple layers. In configurations where multiple layers are used, the individual layers may be formed using the same material or a variety of different materials, each with unique material properties.

[0219] In some embodiments, the textile membrane may include at least one layer that exhibits substantially air-impermeable properties (while maintaining the material properties necessary to provide comfort and minimize pressure points to the patient). For example, as shown in FIG. 40 , in some embodiments, the textile membrane may include an air-impermeable material 10131 (e.g., a silicone layer, a polyurethane coating or film, etc.) formed on one side of the textile material 10133. In some embodiments, the air-impermeable material 10131 and the textile material 10133 may be laminated onto the textile material 10133. In some embodiments, the air-impermeable material 10131 and the textile material 10133 may be selected so that the resulting textile membrane 10135 exhibits a predetermined overall elasticity or elastic resistance as desired. In some embodiments, a force of about (or approximately) 2 N to about (or approximately) 15 N may result in approximately 50% of the maximum displacement of the textile membrane 10135. In some forms, an application of approximately 5 N to approximately 40 N can result in approximately 100% of the maximum displacement of the woven membrane 10135. The air impermeable material 10131 can also have low durometer properties so that the elasticity of the woven material 10133 is not impeded. In other words, the woven membrane 10135 has substantially the same elasticity as the woven material 10133 alone, so that the addition of the air impermeable material 10131 does not substantially reduce the elasticity (or extensibility) of the woven material 10133.

[0220] The air impermeable material 10131 may have a thickness less than the thickness of the woven material 10133. For example, the thickness of the air impermeable material 10131 may be between about (or approximately) 1 micron and about (or approximately) 1 mm. In some forms, the thickness of the air impermeable material may be between about (or approximately) 5 microns and about (or approximately) 0.5 mm. In some forms, the thickness of the air impermeable material 10131 may be between about (or approximately) 20 microns and about (or approximately) 100 microns. Thus, the relatively small thickness of the air impermeable material 10131 does not significantly increase the weight of the woven material 10133, which may help maintain a substantially lightweight woven membrane 10135. A patient interface including a woven membrane 10135 that includes the air impermeable material 10131 may not feel significantly heavier than a patient interface including only the woven material 10133.

[0221] In some examples, the thickness of the woven material 10133 is between about (or approximately) 0.1 mm and about (or approximately) 2 mm. In some examples, the thickness of the woven material 10133 is between about (or approximately) 0.25 mm and about (or approximately) 1 mm. In some examples, the thickness of the woven material 10133 is between about (or approximately) 0.4 mm and about (or approximately) 0.9 mm. In some examples, the thickness of the woven material 10133 is between about (or approximately) 0.6 mm and about (or approximately) 0.8 mm.

[0222] In some examples, the thickness of the air impermeable membrane 10131 is between about (or approximately) 0.01 mm and about (or approximately) 0.10 mm. In some examples, the thickness of the air impermeable membrane 10131 is between about (or approximately) 0.02 mm and about (or approximately) 0.8 mm. In some examples, the thickness of the air impermeable membrane 10131 is between about (or approximately) 0.03 mm and about (or approximately) 0.7 mm. In some examples, the thickness of the air impermeable membrane 10131 is between about (or approximately) 0.04 mm and about (or approximately) 0.6 mm. In some examples, the thickness of the air impermeable membrane 10131 is about (or approximately) 0.05 mm. The air impermeable membrane 10131 may be substantially thin so that the thickness of the woven membrane 10135 (e.g., the combined thickness of the air impermeable membrane 10131 and the woven material 10133) is substantially similar to the thickness of the woven material 10133 alone.

[0223] In some embodiments, the woven material 10133 may be formed as a multi-layer woven fabric. The woven material 10133 may be knitted in a single process (e.g., using double-face, double-knit, and / or double-jersey fabric). As shown in FIG. 40-1 , the woven material 10133 may be constructed from two layers (although any number of layers may be used). The second layer 10133b of the woven material 10133 may be sandwiched between the first layer 10133a and the third layer 10133c. In the illustrated example, the second layer 10133b (i.e., the middle layer) is constructed from spandex, and the first layer 10133a and the third layer 10133c (i.e., the inner and outer layers) are constructed from nylon. However, other materials may be used without departing from the scope and intent of these embodiments (e.g., the material may be any combination of spandex, nylon, and polyester). Additionally, the first layer 10133a and the third layer 10133c may be formed from different materials (ie, not the same materials).

[0224] In some forms, the overall composition of the woven material 10133 can be at least 50% nylon and up to 50% spandex. In some forms, the overall composition of the woven material 10133 can be between about (or approximately) 60% to about (or approximately) 90% nylon and between about (or approximately) 10% to about (or approximately) 40% spandex. In some forms, the overall composition of the woven material 10133 can be between about (or approximately) 70% to about (or approximately) 85% nylon and between about (or approximately) 15% to about (or approximately) 30% spandex. In some forms, the overall composition of the woven material 10133 can be about (or approximately) 82% nylon and approximately 18% spandex.

[0225] In some forms, the laminated structure may provide the woven material 10133 with a spongy feel. In other words, the woven material 10133 may be compliant and capable of deforming upon contact with the patient's face. In particular, the thickness of the woven material 10133 may be capable of thinning when a force is applied and returning to its original shape when the force is removed. Thus, the woven material 10133 may be able to function like a sponge because it can at least partially absorb the applied force. In particular, the spandex layer 10133b (e.g., elasticity) of the woven material 10133 may provide a spongy feel. The spongy feel of the woven material 10133 may assist in providing improved comfort to the patient's skin (e.g., because the woven material 10133 can conform to a variety of facial contours). The spongy feel of the woven material 10133 may also assist in providing an improved seal against the patient's face. In particular, the woven material 10133 may be able to conform to crevices on the patient's face (e.g., the area between the ala of the nose and the nasolabial folds) due to the application of force (e.g., via the positioning and stabilizing structure 3300), but not wrinkle or form a site where air leakage can occur. This may assist the patient in establishing a seal between the skin and the woven membrane 10135 without having to contact the woven membrane 10135 in the same location (which may result in, for example, easier donning of the seal-forming structure 3100). It may also allow the seal-forming structures 3100, 6100, and 9100 to move and / or shift (without leaking) while being worn, because the sponge-like properties assist in maintaining the necessary contact with the patient's skin.

[0226] In some forms, the woven material 10133 is coated (e.g., laminated) with an air impermeable layer 10131 (e.g., liquid silicone rubber) to form the impermeable woven membrane 10135. In the illustrated example, the air impermeable layer 10131 is applied to a single side of the woven material 10133. In other words, the air impermeable layer 10131 may be applied to the first layer 10133a but not to the second layer 10133b or the third layer 10133c. When the woven membrane 10135 is constructed as a seal-forming structure 3100, 6100, 9100, the first layer 10133a is configured to be disposed within the cavity 3101, 6001, 9001, such that the third layer 10133c is configured to face and contact the patient.

[0227] In one form, the textile material 10133 is formed from a finely knitted textile. Specifically, the first layer 10133a and the third layer 10133c are constructed with a fine knit. This may be a textile of less than approximately 100 denier. This may be a textile of less than approximately 50 denier. This may be a textile of approximately 20 denier. This may be a textile of approximately 15 denier. The fine knit of the textile (particularly in the third layer 10133c) may impart a smooth feel to the patient's skin and promote patient compliance (e.g., by improving comfort).

[0228] As shown in FIG. 70, the woven membrane may include multiple layers that exhibit substantially air-impermeable properties (while maintaining the material properties necessary to provide comfort and minimal pressure points to the patient). For example, the woven membrane may include two air-impermeable layers 10131 (e.g., silicone layers, polyurethane coatings or films, etc.) formed on one side of the woven material 10133. In other examples not shown, any number of air-impermeable layers 10131 may be used. The air-impermeable material 10131, in some forms, may be attached to the woven material 10133 using any number of methods (e.g., using an adhesive, using a laminate, etc.).

[0229] In some forms, the air impermeable layers 10131 may be constructed from the same material. In other words, separate layers of the same material may be connected to each other to form the multi-layer air impermeable material 10131. In certain forms, each layer of the air impermeable material 10131 may be substantially identical in shape. In other words, there may be no discernible difference between different layers of the air impermeable material 10131.

[0230] In other embodiments, at least one layer of the air impermeable material 10131 may be different from the other layers. For example, FIGS. 71 and 72 show a first impermeable layer 10137 that is substantially solid and / or uniform and a second impermeable layer 10139 that is segmented or discontinuous. The second layer 10139 may be formed from a plurality of structures 10140. The structures 10140 may be equally spaced (see, e.g., FIG. 71 ) or unequally spaced (not shown). In the illustrated example, the second impermeable layer 10139 may be formed from a plurality of spaced apart spherical or cylindrical structures 10140 (e.g., dots). In other examples (not shown), the structures 10140 may be formed from different shapes (e.g., triangular, rectangular, elliptical, or having other similar cross sections). Yet another example may include a second impermeable layer 10139 having structures 10140 with varying cross-sections (eg, only partially circular).

[0231] In some forms, the first impermeable layer 10137 may have a thickness measured in a direction from the interior of the plenum chamber 3200 (e.g., cavity 3101 in FIG. 16 ) to the second impermeable layer 10139 (e.g., vertically as shown in FIGS. 70 and 70-1 ). In some forms, the thickness of the first impermeable layer 10137 may be between about (or approximately) 0.0001 mm and about (or approximately) 10 mm. In some forms, the thickness of the first impermeable layer 10137 may be between about (or approximately) 0.001 mm and about (or approximately) 1 mm. In some forms, the thickness of the first impermeable layer 10137 may be between about (or approximately) 0.005 mm and about (or approximately) 0.1 mm. In some forms, the thickness of the first impermeable layer 10137 may be between about (or approximately) 0.01 mm and about (or approximately) 0.05 mm.

[0232] In some forms, the density of the first impermeable layer 10137 can be between about (or approximately) 0.1 grams per square meter (gsm) and about (or approximately) 1000 gsm. In some forms, the density of the first impermeable layer 10137 can be between about (or approximately) 1 gsm and about (or approximately) 100 gsm. In some forms, the density of the first impermeable layer 10137 can be between about (or approximately) 10 gsm and about (or approximately) 75 gsm. In some forms, the density of the first impermeable layer 10137 can be between about (or approximately) 30 gsm and about (or approximately) 50 gsm.

[0233] In some forms, the second impermeable layer 10139 may have a thickness measured in a direction substantially parallel to the first thickness direction from the first impermeable layer 10137 to the textile material 10133 (see, e.g., FIG. 70) or to the third impermeable layer 10141 (see, e.g., FIG. 70-1). In some forms, the thickness of the second impermeable layer 10139 may be (between) about (or approximately) 0.0001 mm to about (or approximately) 10 mm. In some forms, the thickness of the second impermeable layer 10139 may be (between) about (or approximately) 0.001 mm to about (or approximately) 1 mm. In some forms, the thickness of the second impermeable layer 10139 may be (between) about (or approximately) 0.005 mm to about (or approximately) 0.1 mm. In some forms, the thickness of the second impermeable layer 10139 may be (between) about (or approximately) 0.01 mm to about (or approximately) 0.05 mm.

[0234] In some forms, the first impermeable layer 10137 can be thicker than the second impermeable layer 10139 (see, e.g., FIG. 70 ). In other forms, the first impermeable layer 10137 and the second impermeable layer 10139 can have the same thickness. In yet other forms, the second impermeable layer 10139 can be thicker than the first impermeable layer 10137.

[0235] In some forms, the density of the second impermeable layer 10139 can be between about (or approximately) 0.1 gsm and about (or approximately) 1000 gsm. In some forms, the density of the second impermeable layer 10139 can be between about (or approximately) 1 gsm and about (or approximately) 100 gsm. In some forms, the density of the second impermeable layer 10139 can be between about (or approximately) 10 gsm and about (or approximately) 75 gsm. In some forms, the density of the second impermeable layer 10139 can be between about (or approximately) 30 gsm and about (or approximately) 50 gsm.

[0236] In some forms, the width of each structure 10140 of the plurality of structures 10140 (e.g., the spherical or cylindrical structures 10140 illustrated in FIGS. 71 and 72) can be between about (or approximately) 0.001 mm and about (or approximately) 10 mm. In some forms, each structure 10140 can be between about (or approximately) 0.005 mm and about (or approximately) 1 mm. In some forms, each structure 10140 can be between about (or approximately) 0.01 mm and about (or approximately) 0.5 mm.

[0237] In some forms, the spacing between each structure 10140 can be between about (or approximately) 0.001 mm and about (or approximately) 10 mm. In some forms, the spacing between each structure 10140 can be between about (or approximately) 0.005 mm and about (or approximately) 1 mm. In some forms, the spacing between each structure 10140 can be between about (or approximately) 0.01 mm and about (or approximately) 0.5 mm.

[0238] In some forms, the density of the second impermeable layer 10139 may be lower than the first impermeable layer 10137 due to discontinuities (e.g., spacing) between the multiple structures 10140 of the second layer 10139.

[0239] As shown in FIG. 71 , the rows of structures 10140 may be offset from one another. For example, the second air impermeable layer 10139 may be formed from a varying (e.g., alternating) pattern of structures 10140 (although in other embodiments, the pattern need not be alternating). The varying pattern may create different spacing between the structures 10140 (e.g., structures 10140 in adjacent rows may be closer together than adjacent structures 10140 in the same row). The varying pattern may make the second air impermeable layer anisotropic. As shown in FIG. 70 , the cross section is not uniform along the length of the woven membrane 10135. A cross section taken along another direction may also be non-uniform and may not be identical to the cross section shown in FIG. 70 . An anisotropic woven membrane 10135 may provide varying material properties along the length of the woven membrane 10135. For example, the woven membrane 10135 may have greater flexibility in one direction and be stiffer in another (e.g., perpendicular) direction. Alternatively or additionally, the woven membrane 10135 may have varying curvature along one direction. For example, the length of the woven membrane 10135 may be less pliable or flexible (i.e., stiffer) around its edges and more pliable or flexible in the center (or vice versa).

[0240] In certain configurations, the shape of the structures 10140 can affect the flexibility of the woven membrane 10135. For example, a similar pattern with rounded shapes (e.g., as in FIG. 71) can be more flexible than angled shapes.

[0241] As shown in FIG. 72 , first and second air impermeable layers 10137 and 10139 (or any other number of layers in another example) are connected together to form air impermeable material 10131. In the illustrated example, second air impermeable layer 10139 may be an adhesive layer. For example, an adhesive layer may be applied to a surface of structure 10140. This adhesive may allow engagement between first and second air impermeable layers 10137 and 10139. Adhesive may also be applied to the opposite side of structure 10140 (i.e., the side opposite the side attached to first air impermeable layer 10137). Adhesive on the opposite side may be used to connect second air impermeable layer 10137 to textile material 10133 (e.g., having any of the described properties). The woven membrane 10135 may be formed of all three (or any other number) layers (i.e., the woven material 10133, the first air impermeable material 10137, and the second air impermeable material 10139).

[0242] As shown in FIG. 70-1 , the air-impermeable material 10133 (e.g., the first layer 10137 and the second layer 10139) may not be connected to the woven material 10133 and may itself form an impermeable or elastomeric membrane. The matrix configuration of the second air-impermeable layer 10139 may still provide anisotropic properties. In this example, the first air-impermeable layer 10137 and the second air-impermeable layer 10139 may be connected to a third impermeable layer 10141 such that the second air-impermeable layer 10139 is an intermediate layer. Alternatively, the air-impermeable material 10133, and therefore the impermeable membrane, may be composed only of the first air-impermeable layer 10137 and the second air-impermeable layer 10139.

[0243] 73, the fabric material 10133 may be a breathable fabric that may allow airflow to reach the patient's skin to improve cooling comfort for the patient.

[0244] In some embodiments, the breathable woven material 10133 may have sufficient porosity to allow pressurized air to pass through to provide a cooling effect. In some embodiments, the porosity may be between about (or approximately) 0.01 L / min and about (or approximately) 10 L / min. In some embodiments, the porosity may be between about (or approximately) 0.05 L / min and about (or approximately) 8 L / min. In some embodiments, the porosity may be between about (or approximately) 0.1 L / min and about (or approximately) 5 L / min. In some embodiments, the porosity may be between about (or approximately) 0.5 L / min and about (or approximately) 2 L / min.

[0245] In some forms, this porosity may be achievable at a positive pressure of at least approximately 4 cmH2O, or at least approximately 6 cmH2O, or at least approximately 10 cmH2O, or at least approximately 20 cmH2O.

[0246] As described above, the woven membrane 10135 may be constructed from an air impermeable material 10131 and a woven material 10133. The air impermeable material 10131 may face the cavity 3101. The air impermeable material 10131 may block the formation of pressurized air exiting the cavity 3101 and may direct the pressurized air back into the cavity 3101. This may create a seal 3130 that seals the cushion assembly 3105 against the patient's face.

[0247] The woven material 10133 may not be impermeable and may allow pressurized air to flow through the material. Because the woven material 10133 is coated with the air-impermeable material 10131, the pressurized air is generally not in contact with the woven material 10133 and cannot escape the cavity 3101. In other words, the rear wall of the cavity 3101 may be at least partially formed by the air-impermeable material 10131 forming part of the woven membrane 11035, and the woven material 10133 may be external to the cavity 3101. However, as shown in FIG. 73 , the airflow may not be completely straight (i.e., vertical) through either nostril opening 3102 (alternatively referred to as nasal openings and / or holes). The vapor lines may move toward the periphery of the nostril opening 3102 (and / or around the mouth-site opening 6104 in FIG. 26 ). This allows the pressurized air to come into contact with the fabric material 10133 instead of entering the patient's nostrils. Once within the fabric material 10133, the pressurized air may be able to escape into the surrounding environment.

[0248] In the illustrated example, pressurized air may enter the woven material 10133 at an angle (i.e., not perpendicular to the thickness of the woven material 10133). The airflow may pass through the woven material 10133 and come into contact with the patient's nose. A solid surface may redirect the airflow back into the woven material 10133, traveling until it reaches the air impermeable membrane 10131. Just as the air impermeable membrane 10131 may restrict air from escaping the cavity 3101, the air impermeable membrane 10131 may also restrict air from entering the cavity 3101. The airflow may alternate between contact with the patient's nose and with the air impermeable material 10131 until the air flows out of the patient's nose and escapes to the environment.

[0249] In some forms, the woven material 10133 backed with the air impermeable material 10131 as described in Figure 70 may provide improved breathability. For example, the second impermeable layer 10139 may be formed with discontinuities between structures 10140, thereby reducing seepage of the impermeable material into the woven material 10133.

[0250] As air travels between the patient's nose and the air impermeable material 10131, the airflow may provide cooling and / or breathability to the patient. For example, the patient may experience airflow across their skin, which may make wearing the cushion assembly 3105 more comfortable. Additionally, the patient may sweat while wearing the cushion assembly 3105. The airflow through the woven material 10133 may provide forced convection and cooling to the patient. Instead of allowing sweat or other moisture to soak into the woven material 10133, which may irritate the patient, the airflow (in conjunction with the woven material 10133) may assist in wicking moisture from the patient's skin to the surroundings. In other words, the airflow through the woven material 10133 may simulate evaporative cooling and remove moisture from the patient's skin to cool the patient. This improves patient comfort and provides a more breathable and / or absorbent cushion assembly 3105.

[0251] Additionally, the fine weave of the fabric may prevent seepage of the air impermeable layer 10131 through the fabric layers 10133 (e.g., during the manufacturing process). For example, the fine weave of the first layer 10133a may limit all seepage or may allow some seepage, but may also substantially limit seepage into the other layers 10133b and 10133c. In other words, the first layer 10133a acts as a barrier, substantially limiting the air impermeable layer 10131 from contacting and / or coating the second layer 10133b or the third layer 10133c. Because the first layer 10133a does not contact the patient, some seepage may be tolerated because the relative stiffness of the first layer 10133a is less important to patient comfort than the firmness of the third layer 10133c (i.e., which directly contacts the patient's skin). Thus, the elasticity of the spandex may not be lost due to contact with the air impermeable layer 10131. Furthermore, the smooth texture of the third layer 10133c may not be lost due to penetration into the air impermeable layer 10131. Because only one side of the woven material 10133 needs to be coated with air impermeable material 10131 (i.e., to make the woven membrane 10135 impermeable), an impermeable membrane 10135 may be constructed that does not substantially restrict patient comfort.

[0252] In some embodiments, when the woven material 10133 is coated with an air-impermeable material, the material properties of the woven membrane 10133 are not substantially affected. For example, because the air-impermeable material 10131 is substantially inaccessible to the second layer 10133b, the elasticity of the spandex forming the second layer 10133b is not substantially reduced. As a result, the entire woven membrane 10135 is able to continue to stretch due to the application of force. Furthermore, if the air-impermeable layer 10131 is permeated, the third layer 10133c may lose its drapeability, potentially causing the third layer 10133c to become stiff. This may reduce the third layer 10133c's ability to form a seal against the patient's face. Therefore, in addition to comfort, isolating the air-impermeable layer 10131 from the third layer 10133c keeps the third layer 10133c substantially relaxed, allowing it to seal against the patient's face.

[0253] In some embodiments, the thickness TI1 of the air impermeable layer 10131 does not exceed approximately 500 microns. In some embodiments, the thickness TI1 of the air impermeable layer 10131 is between about (or approximately) 4 microns and about (or approximately) 400 microns. In some embodiments, the thickness TI1 of the air impermeable layer 10131 is between about (or approximately) 8 microns and about (or approximately) 300 microns. In some embodiments, the thickness TI1 of the air impermeable layer 10131 is between about (or approximately) 12 microns and about (or approximately) 200 microns. In some embodiments, the thickness TI1 of the air impermeable layer 10131 is between about (or approximately) 16 microns and about (or approximately) 100 microns. In some embodiments, the thickness TI1 of the air impermeable layer 10131 is between about (or approximately) 20 microns and about (or approximately) 70 microns. In some embodiments, the thickness TI1 of the air impermeable layer 10131 is about (or approximately) 40 microns.

[0254] In some embodiments, the actual thickness TI2 of the air impermeable layer 10131 in the woven membrane 10135 can be (but is not always) less than the thickness TI1 of the air impermeable layer 10131 before it is coated onto the woven material 10133. In other words, when the air impermeable material 10131 penetrates into the first layer 10133a, the thickness TI1 of the air impermeable layer 10131 partially overlaps with the thickness of the first layer 10133a, so that the thickness TI2 measured from the outer surface (i.e., the surface facing the cavity) of the first layer 10133a to the exposed surface (i.e., the surface facing the cavity) of the air impermeable layer 10131 is less than the overall thickness TI1 of the air impermeable layer 10131.

[0255] Even if the thickness TI2 of the air impermeable layer 10131 is lower (e.g., due to leaching), the density remains substantially the same. In some embodiments, the density of the air impermeable layer 10131 does not exceed approximately 500 grams per square meter (GSM). In some embodiments, the density of the air impermeable layer 10131 is between about (or approximately) 5 GSM and about (or approximately) 400 GSM. In some embodiments, the density of the air impermeable layer 10131 is between about (or approximately) 50 GSM and about (or approximately) 300 GSM. In some embodiments, the density of the air impermeable layer 10131 is between about (or approximately) 100 GSM and about (or approximately) 200 GSM. In some embodiments, the density of the air impermeable layer 10131 is between about (or approximately) 110 GSM and about (or approximately) 130 GSM. In some embodiments, the density of the air impermeable layer 10131 is about (or approximately) 120 GSM.

[0256] Maintaining separation between the air impermeable layer 10131 and the second 10133b (i.e., middle layer) and third 10133c (i.e., patient-contacting layer) layers provides a variety of benefits to the woven membrane 10135. As noted above, the material properties of the woven material 10133 are not substantially sacrificed to achieve the impermeable membrane 10135. Specifically, the third layer 10133 maintains a smooth surface texture for patient comfort, and the second layer 10133b does not substantially lose its elasticity. The first 10133a, third 10133c, and air impermeable layer 10131 may all be elastic, allowing them to stretch along with the second layer 10133b. In particular, the airtight layer may have a low durometer (e.g., between about (or approximately) 20 and about (or approximately) 40, e.g., approximately 30), and therefore may have greater extensibility (e.g., not substantially limit the extensibility of the woven material 10133) compared to a higher durometer airtight layer 10131.

[0257] In other examples, the woven membrane 10135 is constructed entirely from woven material 10133. The woven material 10133 may include air-impermeable threads that impart impermeability onto the woven membrane 10135. Because an additional layer of air-impermeable material 10131 may not be necessary, the woven membrane 10135 may be able to be thinner (i.e., just the thickness of the woven material). The air-impermeable threads may have similar elasticity as threads that are not air-impermeable, so a woven membrane 10135 that includes air-impermeable threads will not lose its extensibility.

[0258] In yet other examples, the membrane is constructed entirely from an elastomeric material (e.g., silicone and / or TPE). An elastomeric-only membrane may be constructed with similar properties and / or structure as any of the woven membranes 10135 described above. For example, the total thickness of the elastomeric-only membrane may be substantially similar to the thickness, hardness, and / or compliance of the woven membrane 10135.

[0259] In some embodiments, the thickness of the elastomer-only film is between about (or approximately) 0.1 mm and about (or approximately) 0.55 mm. In some embodiments, the thickness of the elastomer-only film is between about (or approximately) 0.15 mm and about (or approximately) 0.45 mm. In some embodiments, the thickness of the elastomer-only film is between about (or approximately) 0.2 mm and about (or approximately) 0.35 mm. In some embodiments, the thickness of the elastomer-only film is between about (or approximately) 0.25 mm and about (or approximately) 0.3 mm.

[0260] In some embodiments, the elastomer-only membrane has a durometer hardness of at least 20 Shore A. In some embodiments, the elastomer-only membrane has a durometer hardness of at least 35 Shore A. In some embodiments, the elastomer-only membrane has a durometer hardness of 40 Shore A. This hardness may give the elastomer-only membrane flexibility and drape (e.g., a low drape coefficient) to form complex curvatures and seal against the patient's face. In some embodiments, the elastomer-only membrane may have a lower drape coefficient than the woven membrane 10135.

[0261] In certain configurations, an elastomer-only membrane can be coupled (e.g., molded) to a lower durometer silicone. For example, a 40 Shore A durometer silicone can be molded to a 20 Shore A durometer silicone. This can further increase the drape of the elastomer-only membrane (e.g., compared to an elastomer-only membrane constructed solely from 40 Shore A durometer silicone).

[0262] In some embodiments, the woven membrane 10135 may exhibit a low spring constant (i.e., high compliance) in both warp and weft directions. In some embodiments, a load of about (or approximately) 0.5 N to about (or approximately) 10 N may result in approximately 50% of the maximum displacement of the woven membrane 10135. In some embodiments, a load of about 2 N to about 25 N may result in approximately 100% of the maximum displacement of the woven membrane 10135. In such embodiments, in contrast to conventional designs in which a fixed cushion may cause distortion of the skin of the patient's face 1300 (to form an effective seal), the woven material 10133 and / or the resulting woven membrane 10135 may have a material spring constant and spring length such that the woven membrane 10135 is more compliant than the patient's skin engaging the woven membrane 10135. This may advantageously improve mask comfort and reduce the formation of localized pressure "hot spots" or areas of potential irritation due to contact with the seal-forming structures 3100, 6100, 9100.

[0263] In some forms, the surface of the woven material 10133 that contacts the patient's face 1300 can have low-friction characteristics. This can advantageously increase the surface texture comfort of the woven membrane 10135 and reduce friction against the patient's face 1300. The surface (e.g., herringbone) of the woven material 10133 can have a first coefficient of friction in a first direction. The first coefficient of friction is different (e.g., higher or lower) than the coefficient of friction in a second direction. In contrast, a higher-friction woven material can cause the woven membrane 10135 to snag or rub in the contact area with the patient's face during use. Such rubbing or snagging can cause the woven membrane 10135 to distort or deform, leading to reduced sealing effectiveness and potential undesirable air leakage from the device.

[0264] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate a different size and / or shape range. For example, the system may include one form of seal-forming structure 3100 that is suitable for large head sizes but not small head sizes, and another that is suitable for small head sizes but not large head sizes.

[0265] It should be noted that although reference may be made herein (e.g., using reference numerals) to particular illustrated examples or features of particular illustrated examples (e.g., seal-forming structure 3100), such discussion may also apply to other examples and / or features (e.g., seal-forming structures 6100, 9100).

[0266] 5.3.1.1 Sealing mechanism In one form, the seal-forming structure includes a sealing flange that employs a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to positive system pressure within the plenum chamber 3200 by acting on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0267] In one form, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the periphery of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the periphery. The support flange is or includes a spring-like element that functions to support the sealing flange against buckling during use.

[0268] In one form, a woven membrane 3130 (e.g., comprising nylon, polyester, a blend of nylon and polyester, microfiber, or polyurethane) is used as the face-contacting portion of the seal-forming structure 3100 for a CPAP mask. The woven membrane 3130 may be biocompliant and may provide a substantially smooth and comfortable surface for the patient, which may lead to improved patient compliance (e.g., by eliminating the need for irritating devices). The woven membrane 3130 may have properties that allow it to stretch in at least one dimension. Prior to use, the woven membrane 3130 may be permanently attached (e.g., molded) or may be attached as a removable module to a support structure (e.g., the flexible support structure 3120).

[0269] In one form, the woven membrane 3130 can be formed into a complex three-dimensional predetermined shape so that it is not under tension (e.g., loose, relaxed, and / or wrinkle-free) before and / or during use, yet is substantially free of leakage that can cause wrinkles. The woven membrane 3130 can include one or more curvatures when attached to the support structure 3120, which can assist in conforming to a variety of patient face contours. Before the patient's face (e.g., nose) approaches and presses against the woven membrane 3130, the woven membrane 3130 is adapted to form a consistent surface without obstructions (e.g., wrinkles, folds, or wrinkles). In some forms, this can be achieved by shaping the woven membrane 3130 so that it is substantially free of leakage that can cause wrinkles. This can be advantageous because it ensures that the woven membrane 3130 forms a smooth, continuous seal around and around the patient's face. As a result, improved respiratory pressure therapy may be possible due to reduced occurrence of folds or wrinkles in sections of the seal-forming structure 3100 that may be sources of therapeutic air leakage.

[0270] In some forms, regions of the woven membrane 3130 can be pre-tensioned (e.g., tensioned prior to contact with the patient's face) to stretch slightly, while other regions of the woven membrane 3130 can remain relaxed. In other words, the entire woven membrane 3130 cannot be pre-tensioned. Varying tension on the woven membrane 3130 can advantageously allow for improved sealing efficiency while reducing pressure (i.e., "hot spots") on areas where facial anthropometric elements protrude longer distances into or into the cavity 3101. In some examples, the sides of the nose region (e.g., the lateral sides 3250 and / or corner regions 3252) can remain untensioned and / or relaxed prior to use to provide additional material to accommodate the facial contours of these sensitive facial regions. The lateral sides 3250 and / or corner regions 3252 may intersect a plane substantially perpendicular to the sagittal plane (e.g., substantially parallel to the coronal plane) when the cushion assembly 3105 contacts the patient's face in the use position. In some examples, the bridge region 3104 may extend between the two nostril openings 3102 and may be tensioned, for example, as shown in FIGS. 12-21 . Tensioning the bridge region 3104 may provide one possible way to impart complex shapes (e.g., multiple curvatures) to the woven membrane 3130 (to better contour the shape of the patient's face) and significantly reduce tension throughout the remainder of the woven membrane 3130 (e.g., compared to the bridge region 3104). Using extensive untensioned woven membrane 3130 may provide greater comfort in some configurations because untensioned textiles exert less pressure on the patient's face.

[0271] Continually maintaining the woven membrane 3130 in a wrinkle-free state before and during use allows the woven membrane 3130 to conform to the profile of the patient's face while minimizing wrinkling and / or rupture of the seal-forming structure. This may also allow for improved sealing performance in some forms by maximizing the contact area of ​​the woven membrane 3130 on the patient's face. This may also allow for improved performance of the CPAP device when impacted by external lateral or longitudinal forces (e.g., tubing drag) in some forms.

[0272] In some forms, when the plenum chamber 3200 is pulled a short distance away from the patient's face, the application of air pressure from within the plenum chamber 3200 can assist in maintaining an effective seal at the woven membrane 3130. The application of air pressure can be sufficient to cause the woven membrane 3130 to elastically stretch in at least one dimension, forming a "hovercraft"-like balloon effect over the anthropometric contours of the patient's face 1300, thereby maintaining an effective seal over the anthropometric contours of the patient's face 1300.

[0273] In some embodiments, the woven membrane 3130 may be held by a relatively rigid support structure 3120. In various embodiments, the support structure 3120 may be formed from, for example, silicone, PU foam, PU solid material, or another suitable material. The support structure 3120 may be more rigid than the woven membrane 3130 but may also be described as flexible and may be able to flex or bend under tension. In some embodiments, the support structure 3120 may be relatively rigid than the shell or frame of the plenum chamber 3200 (e.g., formed from a rigid plastic). In other embodiments, the plenum chamber 3200 does not include a shell or frame and is constructed entirely of the woven membrane 3130 and support structure 3120.

[0274] In some forms, the magnitude of the tensile stress may be varied across the seal-forming structure 3100 woven membrane 3130 as desired. The bridge regions 3104 may be held in tension, and the remainder of the woven membrane 3130 may be understood as not stretched in contrast to the bridge regions 3104. While the bridge regions 3104 are shown in the center of the woven membrane 3130, the bridge regions 3104 (or any similar feature that is selectively tensioned) may be located anywhere throughout the woven membrane 3130. However, different locations on the woven membrane 3130 may have different levels of tension (i.e., all lower than the bridge regions 3104). For example, areas of stress concentration may exist near one or more holes (e.g., nostril openings 3102) in the woven membrane 3130 where treatment is applied, or in more stretched material. In some examples, the area of ​​the woven membrane 3130 directly connected to the support structure 3120 (e.g., the periphery) may be held under higher tension than the radial interior of the woven membrane 3130, except for the bridge region 3104, which may contain the highest tension.

[0275] In some forms, the seal-forming structure 3100 may use a number of different cushion configurations (e.g., a single air-assisted woven membrane 3130, a double air-assisted woven membrane 3130, a woven membrane 3130 with a compression support, or a woven membrane 3130 with a TPU / TPE / Si support). In some forms, the cushion configuration of the seal-forming structure 3100 may be configured to advantageously provide a "one size fits most" solution.

[0276] In examples, the seal-forming structure 3100 and plenum chamber 3200 may be applied to nasal cushions, nasal cradles, oral-nasal cushions, miniature full face masks, full face masks, and other suitable cushion arrangements.

[0277] In some forms, the woven membrane 3130 can be configured to create an effective seal against the subnasal point of the patient's nose, so that the woven membrane 3130 does not engage the nasal tip, as shown, for example, in Figure 23. In some forms, the woven membrane can be configured to create an effective seal over the patient's nasal tip (not shown).

[0278] In some forms, as the air pressure within the cavity 3101 applies a load against the interior surface of the textile membrane (e.g., air impermeable layer 10131) creating additional tensile stress, the textile membrane 3130 substantially fills the compressed contours of the patient's face 1300 (e.g., around the alar area, near the nostril edges). In some forms, the elasticity of the textile membrane 3130, combined with the applied load of the internal air pressure, causes the textile membrane 3130 to elastically stretch, creating a larger sealing contact area on the patient's face. This can also be advantageous in some forms for providing a continuous seal even when the mask is partially displaced from its optimal interface with the patient's face because the textile membrane 3130 can partially expand due to the opposing force from the internal air pressure (i.e., the "hovercraft effect").

[0279] In some configurations, such as those shown in FIGS. 19-21 and 37-39, one or more grip pads 3150, 9150 may be disposed on the woven membrane 3130, 9130. In one example, the grip pad 3150, 9150 may be configured to be substantially flat along the patient-facing surface of the woven membrane 3130, 9130. In another example, the grip pad 3150, 9150 may be embossed to form a bead or rim on the grip pad 3150, 9150 that protrudes slightly above the surface of the woven membrane 3130, 9130. In some configurations, the grip pad 3150, 9150 may have a high coefficient of friction. In some configurations, the grip pad 3150, 9150 may have a predetermined shape (e.g., oval (see FIGS. 19, 21, 37, and 39), circular, square, etc.). In some forms, the grip pads 3150, 9150 may be elongated (see FIGS. 19 and 37). In some forms, the grip pads 3150, 9150 may be linear. In some forms, the grip pads 3150, 9150 may be arranged in a pattern across the surface of the seal-forming structure 3100, 9100. In some forms, the grip pads 3150, 9150 may be arranged so as to be scattered across the surface of the seal-forming structure 3100, 9100 (see FIGS. 21 and 39). In some forms, the grip pads 3150, 9150 may be arranged to form a perimeter near the periphery of the textile membrane 3130, 9130 (see FIGS. 19, 20, 37, and 38). In some forms, the grip pads 3150, 9150 forming the perimeter may take the form of a dotted line (see FIGS. 19 and 37). In some forms, the grip pads 3150, 9150 forming the perimeter can take the form of solid lines (see FIGS. 20 and 38). In some forms, the grip pads 3150, 9150 forming the perimeter can take the form of multiple lines (dotted or solid) or a combination thereof. In some forms, the grip pads 3150, 9150 can assist the fabric membrane 3130, 9130 in gripping against the patient's face.In one example, the grip pad 3150, 9150 may be formed as a relatively thin silicone layer added to the surface 3130, 9130 of the woven membrane. In any of the above configurations, the grip pad 3150, 9150 may provide additional material (e.g., textile and silicone) that contacts the patient's face. While not providing the level of comfort that would be obtained from an entire textile surface (e.g., if only the textile material of the woven membrane were in contact with the patient's nose), providing the grip pad 3150, 9150 on the woven membrane 3130, 9130 may provide the benefit of helping to securely hold the seal-forming structure 3100, 9100 in place (e.g., for delivery of therapeutic pressure to the patient). Furthermore, because only a small area is covered with silicone (or other gripping material) (compared to a relatively large area of ​​textile (or entirely made of silicone)), it may be more comfortable for the patient than if the entire seal-forming structure 3100, 9100 were formed from silicone (or other similar material).

[0280] In some forms, the textile membrane 3130 may be integral with the support structure 3120 by attaching (e.g., molding) the outer edge (e.g., perimeter) of the textile membrane 3130 around the lip (e.g., inner edge) of the curved edge of the support structure 3120. In one example, the textile membrane 3130 is attached to provide a front surface of the seal-forming structure 3100. Because the textile membrane 3130 also extends in the anterior direction, the textile membrane 3130 is curved away from the anterior surface. In other words, the textile membrane 3130 is curved to extend beyond the anterior surface, providing additional surface area of ​​textile material exposed to the patient. This arrangement may be advantageous in that substantially the entirety of the patient's face in contact with the seal-forming structure 3100 is in contact with the textile membrane 3130. This may be useful in improving patient compliance, as patients may be more likely to wear the patient interface 3000 using the woven membrane 3130 (rather than patient interfaces 3000 using at least certain other materials in the face-contacting areas, such as silicone) because contact with the woven membrane 3130 may be more comfortable for the patient.

[0281] In one example, the attachment of the woven membrane 3130 to the support structure 3120 is performed by a specific process (described below) that may result in the formation of a curved region without the occurrence of folds, wrinkles, creases, or buckling in the woven membrane surface 3130. As will be appreciated, in some examples, at the transition region 36, both the support structure 3120 and the woven membrane 3130 may have a radius of curvature (e.g., the same or similar radius of curvature) along the curved portion 35 in the direction from the front side of the seal-forming structure 3100 to the rear side of the seal-forming structure (see FIGS. 16-18). The woven membrane 3130 may be imparted with a predefined curvature such that the portion of the woven membrane 3130 that is not directly supported by the support structure 3120 extends along the curved portion 35 (FIGS. 16-18). Although the woven membrane 3130 may be held at low tension relative to the support structure 3120, because the woven membrane 3130 is not directly supported by (e.g., not in direct contact with) the support structure 3120, the support structure 3120 may be considered to be substantially relaxed (e.g., under less tension than the bridge region 3104). This may assist in creating a dome shape (e.g., a convex dome) in certain regions of the woven membrane 3130 (e.g., the lateral sides 3250 and / or corner regions 3252), which may assist in sealing the woven membrane 3130 against the contours of the patient's face (e.g., the alar region of the patient's face (i.e., the corners of the nasal region (i.e., the region where the alar terminates on the upper lip adjacent the nasolabial fold))), as shown, for example, in FIG. 12 . The dome shape may assist in avoiding the formation of wrinkles, fine lines, folds, and buckling in the woven membrane 3130, which may assist in the development of leak paths. The dome shape may also assist the woven membrane 3130 in reaching areas of the patient's face that are difficult to seal, such as the corners of the nose. The woven membrane 3130 may have a saddle shape in the mid-subnasal point region 3260 configured to seal against the patient's subnasal point, thereby conforming to the saddle shape formed by the patient's nasolabial angle and upper lip, as shown in Figure 12. Similarly, the nasal tip point region 3270 may also have a saddle shape configured to seal against a conforming profile presented at or below the patient's nasal tip.The curvature (e.g., the curvature and / or the magnitude of the radius of curvature) of the woven membrane 3130 in the direction of the curved portion 35 may be different in different regions of the cushion assembly along the periphery 3130 of the woven membrane. For example, as shown in FIG. 16 , the woven membrane 3130 in the mid-nasal tip region 3270 may have a different curvature in the direction of the curved portion 35 than the woven membrane 3130 in the mid-subnasal point region 3260. In one example, the curvature (e.g., the curvature and / or the magnitude of the radius of curvature) at the lateral sides 3250 of the woven membrane 3130 may be different from the curvature in the mid-nasal tip region 3270 and / or the mid-subnasal point region 3260.

[0282] In some forms, the woven membrane 3130 may be angled or curved slightly inward (e.g., a positive dome curvature in the left-right direction) as it approaches the interior of the mask, as shown, for example, in Figures 12-21. In some forms, the woven membrane 3130 may form a dome shape on the support structure 3120, as shown, for example, in Figures 26-33. It should be noted that any of the cushion assemblies 6105, 9105 disclosed herein may have a textile membrane 6130, 9130 attached to the outer edge of the support structure 6120, 9120 such that the textile membrane 6130, 9130 forms part of the portion of the seal-forming structure 6100, 9100 that extends from the front to the rear, face-contacting side of the seal-forming structure along curved portion 35 as described above with reference to FIG. 12, e.g., such that the textile membrane 6130 of the cushion assembly 6105 may have more of a dome shape with a negative curvature from one lateral side to the other (e.g., along the side-to-side direction as shown in FIG. 26). In other words, the textile membrane 6130 may be attached to the support structure 6120 with curvatures in different directions and / or about different axes such that the textile membrane 6130 may be formed with both an inward curve and a dome shape. In one example, the majority of the woven membrane 6130 includes a positive (e.g., inward) curvature that can cradle a portion of the patient's face, and only the periphery (e.g., the area adjacent the support structure) is dome-shaped (e.g., includes a negative curvature).

[0283] In some forms, the central portion of the woven membrane 3130 has a saddle-like shape. In other words, the periphery of the woven membrane 3130 may be shaped to have a negative dome curvature (e.g., relative to a patient's face in use) and the central portion includes a positive dome curvature (e.g., around the bridge portions 3104), such that the central portion (e.g., near the bridge portions 3104) may be considered a minimax point and thus a saddle (e.g., relative to a patient's face in use).

[0284] In some configurations where the woven membrane 3130 is not under continuous tension or is inelastic (before and / or during use), the woven membrane 3130 may form an improved air-assisted seal on the patient's face that dynamically adapts to changes / movements (i.e., a "hovercraft" effect), for example, due to the woven membrane 3130 being thinner and having less structural stiffness than the support structure 3120 (e.g., a silicone membrane).

[0285] In some configurations, the woven membrane 3130 may be supported by a secondary or tertiary support structure that may function as a cushion support. The cushion support may provide additional flexibility and may be suitable for use with most patient faces (one size fits most). The second or third support layer may be formed using a woven membrane, a woven including a PU / Si membrane, laminated open-cell foam, laminated PU foam, molded PU, TPU / TPE, or silicone. In some configurations, the additional support layer may itself be supported by a structural / rigid plastic (e.g., PP / PC / PA / PET or other suitable material).

[0286] In some forms, 3D printing the fabric membrane and / or cushion support section as a "skeleton" can reduce thickness and, consequently, mask weight.

[0287] In some configurations, different layers of the mask layer can be printed with different stiffness, hardness, or thickness. For example, the "skeleton" section can be made using Si, PU foam, PU solid material, or any suitable plastic material.

[0288] In one form, the seal-forming structure may include a compression seal or gasket seal that is constructed and arranged to be in compression in use due to, for example, elastic tension in the positioning and stabilizing structure.

[0289] In one form, the seal-forming structure includes tensioning portions, which may be located in any number of distinct locations throughout the seal-forming structure, and in use, the tensioning portions are held taut by, for example, adjacent regions of the sealing flange.

[0290] In one form, the seal-forming structure includes an area having a sticky or adhesive surface.

[0291] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension section, and a section having a sticky or adhesive surface.

[0292] 5.3.1.2 Nasal bridge or nasal ridge area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal on the nasal bridge or nasal ridge region of the patient's face.

[0293] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the nasal bridge or nasal ridge region of the patient's face in use.

[0294] 5.3.1.3 Upper lip area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the upper lip region (ie, upper lip) of the patient's face.

[0295] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face in use.

[0296] 5.3.1.4 Jaw area In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the chin area of ​​the patient's face.

[0297] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the chin region of the patient's face in use.

[0298] 5.3.1.5 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 may cover the eyes when in use.

[0299] 5.3.1.6 Nasal pillow In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each constructed and arranged to form a seal with a respective nostril of the patient's nose.

[0300] 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.

[0301] 5.3.2 Nasal cushion 6-21, a patient interface 3000 having a cushion assembly 3105 including a seal-forming structure 3100 and a plenum chamber 3200 is shown in accordance with a first embodiment of the present technology.

[0302] The example seal-forming structure 3100 described in the above paragraph can be considered a nasal cradle cushion and is intended to provide a flow of pressurized gas to the patient's nares by sealing at least below the patient's nose. The example seal-forming structure 3100 engages the patient's face below the bridge of the nose, and in some instances, depending on the size and shape of the patient's nose, below the nasal tip. The example seal-forming structure 3100 can also engage the patient's face at least above the upper vermilion lip. Thus, the example seal-forming structure 3100 can seal against the patient's upper lip during use. Furthermore, because the patient's mouth can remain exposed by the example seal-forming structure 3100 described, the patient can breathe freely (i.e., breathe directly into the atmosphere) (unobstructed by the seal-forming structure 3100). The under-nose nasal cradle can be configured without an aperture sized to receive the patient's nose within its cavity. Additionally, the height of the cushion 3105 from the lower edge of the woven membrane in the mid-subnasal point region to the upper edge of the woven membrane 3130 in the mid-nasal point region may be less than the width of the cushion 3105 in the left-right direction from one lateral edge of the woven membrane 3130 to the other lateral edge of the woven membrane 3130 (see, e.g., FIG. 12).

[0303] An example of a nasal cradle cushion 3105 (e.g., the exemplary seal-forming structure 3100 disclosed herein) may include a suprasellar or concave region with a positive curvature across the cushion. Additionally, the nasal cradle cushion 3105 may be understood as having a single target seal-forming area or surface, while the pillow cushion may have two target seal-forming areas (one for each nostril). The cradle cushion 3105 may also have a posterior wall that contacts the patient's upper lip, and an upper central surface that contacts the underside of the patient's nose (e.g., the patient's subnasal point and / or bridge of the nose). These two surfaces on the patient's face may form a nasolabial angle between them (see FIG. 2E). The cradle cushion 3105 may be shaped to have a nasolabial angle between 90 degrees and 120 degrees.

[0304] Additionally, the exemplary seal-forming structure 3100 may be shaped and dimensioned such that no portion of the seal-forming structure 3100 substantially penetrates into the patient's nares during use. In other words, although portions of the seal-forming structure 3100 may contact the rim of the nostrils and may extend slightly inward in some orientations, the seal-forming structure 3100 does not substantially seal within the nasal passages (e.g., in contrast to a nasal pillows-style mask).

[0305] 5.3.2.1 Plenum chamber 6-21, the plenum chamber 3200 has an edge shaped to be complimentary to the surface contours of an average human face in the area where a seal will be formed in use. In use, the periphery of the plenum chamber 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around any portion of the edge of the plenum chamber 3200 in use (e.g., around the entire edge, around a majority of the edge, etc.).

[0306] In certain forms of the present technology, the plenum chamber 3200 may be constructed from a flexible material (e.g., silicone) and may be formed as a one-piece structure with the support structure 3120 (e.g., from any of the materials described herein as suitable for the support structure 3120 and / or plenum chamber 3200). In some examples, the seal-forming structure 3100 may be an extension of the plenum chamber 3200 such that the plenum chamber 3200 includes the seal-forming structure 3100, or may be formed as part of the plenum chamber 3200. In such examples, the support structure 3120 and the woven membrane 3130 may be considered part of the plenum chamber 3200 (e.g., the seal-forming structure 3100 at least partially forms the interior volume of the plenum chamber 3200). In some examples, the plenum chamber 3200 may be constructed from a transparent material (e.g., clear silicone). The utilization of a transparent material may reduce the intrusiveness of the patient interface 3000 and may help improve compliance with treatment. The use of a transparent material may assist the clinician (or patient) in verifying the placement and function of the patient interface (e.g., to ensure a proper seal) and in verifying the cleanliness of the patient interface 3000. Using a transparent material may allow the clinician or patient to observe debris (e.g., dirt, mold) buildup within the plenum chamber 3200, allowing for cleaning or replacement of the patient interface 3000. This may provide a sense of cleanliness to the patient when wearing the patient interface and may help ensure the patient is not inhaling harmful materials, both of which may lead to improved patient compliance. A translucent material may be used instead of or in addition to a transparent material and may provide similar benefits to the patient. Alternatively, the plenum chamber 3200 is constructed from a relatively rigid material (e.g., polycarbonate) compared to the seal-forming structure 3100. To achieve similar benefits of a flexible transparent material (eg, to allow for viewing), the rigid material may be constructed from a transparent and / or translucent material (eg, clear polycarbonate).In configurations in which the seal-forming structure 3100 is an elastomeric-only membrane, the plenum chamber 3200 and the seal-forming structure 3100 may be constructed from the same or similar materials (e.g., both may be constructed at least in part from silicone). However, because the plenum chamber 3200 is not in direct contact with the patient's face and does not need to be as flexible, the thickness of the plenum chamber 3200 may exceed the thickness of the seal-forming structure 3100.

[0307] In some forms, the seal-forming structure 3100 may include a plenum chamber 3200 connecting opening where the seal-forming structure 3100 is sealingly joined to the plenum chamber 3200. The seal-forming structure 3100 and the plenum chamber 3200 may at least partially form a cavity 3101 that is pressurized by the airflow. In the illustrated embodiment, the seal-forming structure 3100 and the plenum chamber 3200 together form the cavity 3101. At least one opening (e.g., a pair of nostril openings 3102) may be used in the seal-forming structure to allow fluid communication between the cavity 3101 and the patient's nares. However, the nostril openings 3102 are not large enough to accommodate the patient's nose (e.g., the tip of the nose) within the cavity 3101.

[0308] The connection between the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening 3106 may be a permanent connection. The connection between the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening 3106 may be a chemical bond. The joining of the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber 3200 connection opening may be made without a mechanical connection. Alternatively, the joining of the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening may be made with a mechanically detachable connection.

[0309] At each lateral side of the plenum chamber 3200 (e.g., left and right sides as shown in FIG. 13 ), the plenum chamber lateral ends 3202 may be in the form of a hollow passageway forming a plenum chamber inlet port sized and configured to receive airflow. A plenum chamber connector 3204 may also be provided on each lateral side of the plenum chamber 3200 outwardly of the plenum chamber lateral ends 3202. The plenum chamber connector 3204 may connect to each end 3314 of the positioning and stabilizing structure 3300. The connection between the plenum chamber connector 3204 and each end 3314 of the positioning and stabilizing structure 3300 may be releasable on both sides. In other examples, a permanent connection may be provided on one side and a releasable connection on the other side. In a further example, the connection between the plenum chamber connector 3204 and each end 3314 of the positioning and stabilizing structure 3300 may be permanent on both sides.

[0310] The plenum chamber lateral end 3202 may receive a pressurized gas flow from a positioning and stabilizing structure 3300 (e.g., conduit headgear). The pressurized gas flow may then pass through the plenum chamber 3200, then through the seal-forming structure 3100, and into the patient's airway for inspiration.

[0311] The ends 3314 (e.g., openings in each conduit) of the positioning and stabilizing structure 3300 may be connected to the plenum chamber lateral ends 3202. In these embodiments, each plenum chamber connector 3204 may include a slot 3209, a chamfered edge 3208, and a notch 3206 that may be removably connected to a clip on the positioning and stabilizing structure with a snap fit.

[0312] 5.3.2.2 Seal formation structure of this technology The seal-forming structures 3100 may each include a support structure 3120 that supports a sealing portion 29130 (e.g., a fabric membrane) that creates a seal with the patient's face. The sealing portion 29130 is configured to sealingly engage the patient's face (e.g., when pressurized air is supplied to the plenum chamber 3200). Alternatively, or in addition, the support structure 3120 may be molded into the elastomeric-only membrane. The support structure 3120 may have a different thickness (e.g., be thicker) than the elastomeric-only membrane to support the elastomeric-only membrane in its molded position.

[0313] In one example, the seal-forming structure 3100 may include a support structure having at least two regions (e.g., two, three, four, etc. regions) of different thicknesses (e.g., the seal-forming structure 3100 includes a support structure 3120 (having a wall structure with a lateral support region 3122 of greater thickness relative to other portions of the wall structure). For example, as shown in FIGS. 58 and 59, some portions 3123 of the support structure 3120 may be thicker than portions 3124, 3126 of the support structure 3120. For example, the thicker portion 3123 may be adjacent to or connect to the plenum chamber 3200, and the portions 3124, 3126 may be adjacent to or connect to the woven membrane 3130 to provide structural stability in connection with the plenum chamber 3200 and flexibility in the interface with the patient. Alternatively, thicker lateral support regions 3122 may be positioned, for example, at the corners of the nasal region of the seal-forming structure (e.g., directly connected to the fabric membrane) to ensure proper sealing in the alar region of the patient's face.

[0314] Additionally, in the described embodiment, each woven membrane (e.g., seal) may include two separate nostril openings 3102, each corresponding to one of the patient's nostrils, to provide airflow to both of the patient's nostrils. A bridge region 3104 may be provided between the nostril openings 3102. The bridge region 3104 may help the woven membrane maintain a desired shape before and / or during use.

[0315] The seal 3130 may be less rigid than the support structure 3120 and may be constructed, for example, from a woven material (e.g., nylon, polyester, a blend of nylon and polyester, microfiber, or polyurethane) as described in more detail below. The seal 3130 described in any of the examples of the present disclosure may be referred to as a woven seal or woven membrane and may include a woven material that is air impermeable (e.g., a material that has been laminated, coated, or otherwise added to it).

[0316] The support structure 3120 may have an aperture formed therein, thereby providing an inner edge of the support structure 3120. Along this inner edge, the sealing portion 3130 (e.g., the outer periphery of the sealing portion 3130) is attached to the support structure 3120, extending radially inward of the seal-forming structure 3100 (beyond or further than the support structure), as shown, for example, in FIGS. 12-21 . For example, the sealing portion 3130 may be molded around the inner edge of the support structure 3120, or may be connected to the support structure 3120 in other suitable manners, as described below.

[0317] 12-15, the wall structure of the seal-forming structure 3100 may include lateral support regions 3122 that are thicker relative to the remainder of the wall structure of the support structure 3120. A lateral support region 3122 may be provided on each lateral-most side of the seal-forming structure 3100. The seal-forming structure 3100 may include two lateral support regions 3122. Each of the two lateral support regions 3122 is spaced distally from a plane that bisects the seal-forming structure 3100, the plane being parallel to the patient's sagittal plane in use. The lateral support regions 3122 may be the thickest portions of the seal-forming structure 3100, thereby providing resistance to lateral displacement (such as may occur when a patient rests their head on a pillow and presses laterally against the seal-forming structure) and robust engagement with the patient's wings. The thickness of the lateral support regions 3122 may be from about 0.9 mm to about 1.5 mm, or from about 1.3 mm to about 1.4 mm, or from about 1.3 mm, or from about 1 mm to about 1.5 mm. Because the lateral support regions 3122 are the thickest regions in the seal-forming structure 3100 in the depicted figures, the lateral support regions 3122 may also provide the greatest resistance to deformation.

[0318] The woven membrane 3130 may be configured such that it forms a portion of the seal-forming structure 3100 that extends in a curved manner from the anterior portion to the posterior, face-contacting side of the seal-forming structure 3100, as described above. That is, as the woven membrane 3130 contacts the support structure 3120 in the transition region 36, the woven membrane portion 3130 may be configured to engage with the alar region of the patient's face (i.e., the region where the alar terminates at the upper lip near the nasolabial fold), an area of ​​particularly complex geometry. The alar region of the patient's face has particularly complex geometry because at least three facial surfaces (the alar, upper lip, and cheek) converge in this region. As a result, the seal-forming structure 3100 may be more flexible and compliant (e.g., not under tension near the periphery of the woven membrane 3130) so that it can more easily conform to the contours of the patient's face.

[0319] As mentioned above, Figures 19-21 show grip pads 3150 on the surface 3130 of the textile membrane.

[0320] 5.3.2.3 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.

[0321] 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.

[0322] In one form, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the attractive force on the patient interface 3000.

[0323] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate any potential destructive effects on the patient interface 3000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0324] 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.

[0325] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a supine sleeping position with the posterior region of the patient's head resting on a pillow.

[0326] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleeping position with the side region of the patient's head resting on a pillow.

[0327] 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 forces from being transmitted along the positioning and stabilizing structure 3300 to the posterior section, disrupting the seal.

[0328] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient-contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes loop material that engages with portions of hook material.

[0329] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a stretchable (e.g., stretchable with elasticity) strap. For example, the strap can be configured to be tensioned in use to direct a force that forces the seal-forming structure 3100 into intimate contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0330] 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.

[0331] 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.

[0332] 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.

[0333] 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.

[0334] 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.

[0335] 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.

[0336] 5.3.2.3.1 Positioning and stabilizing structures of the technology 6 shows an example of the present technology including a positioning and stabilizing structure 3300. In this example, the positioning and stabilizing structure 3300 includes a lateral portion 3302 and an upper portion 3304 in the form of a conduit that directs pressurized gas flow from a hub 3306 to an end portion 3314. The positioning and stabilizing structure 3300 may be positioned such that, in use, the hub 3306 and decoupling structure 3500 are positioned above the patient's head. As described below, the decoupling structure 3500 may be rotatable within the hub 3306 such that when the patient is wearing the patient interface 3000, for example during treatment, the hub 3306 and decoupling structure 3500 are positioned above the patient's head, allowing the patient greater freedom of movement (without entanglement with the air circuit 4170).

[0337] The positioning and stabilizing structure 3300 may be constructed from silicone. For example, the lateral portion 3302, upper portion 3304, hub 3306 and lateral ends 3314 may be constructed or molded from a single piece of silicone.

[0338] The upper portion 3304 of the positioning and stabilizing structure 3300 has peaks and valleys (or bellows) that allow the upper portion 3304 to conform to the shape of corresponding portions of a patient's head during use. The peaks and valleys of the upper portion 3304 allow the upper portion 3304 to expand or contract along a longitudinal axis to accommodate larger or smaller heads. The peaks and valleys of the upper portion 3304 allow the upper portion 3304 to flex to different radii of curvature to accommodate different shapes and sizes of patient heads.

[0339] The lateral portions 3302 of the positioning and stabilizing structure 3300 may not be formed with the peaks and valleys of the upper portion 3304. As such, the lateral portions 3302 may be able to be less extensible and flexible than the upper portion 3304, which may be advantageous as it reduces the shape and size variability of the sides of the patient's head.

[0340] The end 3314 may connect to each plenum chamber lateral end 3202. As described above, the plenum chamber lateral ends 3202 receive the flow of pressurized gas from the positioning and stabilizing structure 3300. This flow of pressurized gas passes through the plenum chamber 3200 and the seal-forming structure 3100 to the patient's airway. As described above, the end 3314 may connect to a plenum chamber connector 3204 of each plenum chamber lateral end 3202.

[0341] The positioning and stabilizing structure 3300 may be constructed and arranged to direct the force / tension provided by the lateral portion 3302 into a partially superior and partially posterior force vector that is applied to the plenum chamber 3200. Specifically, this partially superior and partially posterior force vector causes the fabric membrane of the seal-forming structure 3100 to make sealing contact below the patient's nose (e.g., at or below the nasal tip and at least above the upper vermilion lip).

[0342] Additionally, the lateral portions 3302 may each include a tab 3308 that receives a rear strap end 3311 of the rear strap 3310. The rear strap 3310 may be adjustable in length, for example, by a hook and loop material arrangement so that one of the rear strap ends 3311 and the remainder of the rear strap 3310 has the hook material on the exterior and the other has the loop material on the exterior. In this manner, the rear strap 3310 is adjustable in length so that tension on the lateral portions 3302 can be increased to draw the seal-forming structure 3100 into sealing engagement with the patient's face at a desired amount of pressure (i.e., tight enough to avoid leakage but not so tight as to cause discomfort).

[0343] The lateral portion 3302 may also be provided with a sleeve 3312 to cushion the patient's face from the lateral portion 3302. The sleeve 3312 may be constructed of a soft feeling, breathable fabric material. After the end 3314 is detached from the plenum chamber lateral end 3202, the sleeve 3312 may be able to be removed from the lateral portion 3302.

[0344] As shown in FIGS. 6-6-2, the positioning and stabilizing structure 3300 provides a force F conduit that maintains the plenum chamber 3200 in a sealing position on the patient's face. The positioning and stabilizing force F conduit may be a resultant force from various force vectors of different elements of the positioning and stabilizing structure 3300. For example, each lateral portion 3302 may provide a rearwardly and respective laterally directed force F conduit to hold the seal-forming structure 3100 against the patient's face (sealing into the upper lip and under the nose) and counter the effect of the positive pressure in the plenum chamber 3200 (i.e., F plenum ) to lift it off the face. The directed force F conduit may also be directed at least partially upwardly to overcome the gravitational force F g . While the gravitational force F g is shown in detail with respect to the seal-forming structure 3100 and the plenum chamber 3200, gravity acts on the entire patient interface 3000 (i.e., in the same direction as the illustrated gravitational force F g ).

[0345] The attractive force Fg may be opposed by a frictional force Ff, which may act in the opposite direction to the attractive force Fg. Then, when gravity pulls the seal-forming structure 3100 and plenum chamber 3200 downward (as shown in FIG. 6), the frictional force Ff acts upward. For example, the patient may experience a frictional force Ff against their upper lip (and / or other surfaces of the patient's face in contact with the seal-forming structure 3100) to oppose the downward movement (which may help stabilize the cushion in place). While the frictional force Ff opposing the attractive force Fg of the seal-forming structure 3100 and plenum chamber 3200 is shown in detail, components of the overall frictional force (not shown) will also oppose the attractive force Fg associated with the positioning and stabilizing structure 3300 (e.g., the lateral portion 3302) and any other portions of the patient interface 3000. The frictional force may act along any location where the patient interface 3000 comes into contact with the patient's skin (or hair). A friction force Ff extends along the patient's skin (or hair) in the opposite direction to the attractive force Fg.

[0346] There may also be an additional component of frictional force (not shown) that opposes the tensional force applied by the positioning and stabilizing structure 3300. When tension is applied to each individual element of the positioning and stabilizing structure 3300 (e.g., each lateral portion 3302, upper portion 3304, rear strap 3310, etc.), friction may counter the tension at the location of the individual element. In other words, the patient may experience these tensional forces in a direction that is directly opposite the tensional forces along the skin (or hair). The frictional force may be directed anteriorly and / or downwardly, or posteriorly and / or upwardly opposite the tensional force of the lateral portions 3302. The frictional force may be directed upwardly and / or anteriorly, or downwardly and / or posteriorly opposite the tensional force of the rear strap 3310.

[0347] In some forms, the lateral portion 3302 can provide a force FTP that is directed toward the patient's head when the lateral portion 3302 is configured as an air delivery conduit. The force FTP aids in gripping the patient's head. This force can be generated by expansion of the conduit during normal use. In some forms, the force FTP can provide a cushioning effect to the patient's head. The lateral portion 3302 can be designed to limit expansion of the conduit to prevent excessive gripping of the patient's head.

[0348] The position of the patient's head can also change the force FTP. For example, if the patient is lying on their side (as in FIG. 6-2), the weight of the patient's head will compress one conduit, causing the other conduit (e.g., the lateral portion 3302 that is not between the patient's head and a sleeping surface such as a pillow) to expand more (and cause a greater FTP) in order to keep the flow rate of pressurized air substantially the same.

[0349] In some forms, an air delivery conduit (not shown) attached to the decoupling structure 3500 can provide the tube drag FTD. Because the decoupling structure 3500 can be pivotable and the patient's position can change during sleep (e.g., tossing and turning), the orientation of the tube drag FTD can change throughout the night or from night to night.

[0350] In some forms, the sum of the various forces may be equal to zero so that the patient interface 3000 is in equilibrium (e.g., not moving along the patient's face during use). Specifically, the attractive force Fg and the ejection force Fplenum tend to retract the seal-forming structure 3100 from the desired sealing position. The positioning and stabilizing force FPSS is added to counteract the attractive force Fg and the ejection force Fplenum (as well as any frictional force Ff) and keep the seal-forming structure 3100 properly positioned. The positioning and stabilizing force FPSS may exceed the sum of the other forces and still maintain the seal-forming structure 3100 in the proper sealing position, although patient comfort may be sacrificed. Maximum patient comfort may be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilizing force FPSS is large enough to achieve this. As described below, various positions of the patient's head while using the patient interface 3000 may determine the positioning and stabilizing force FPSS required to achieve equilibrium.

[0351] 6, the attractive force Fg of the patient interface 3000 may be oriented substantially perpendicular to the plenum chamber force Fplenum and / or the positioning and stabilizing force FPSS. In this orientation, the patient may be in an upright position (e.g., sitting in bed). As noted above, the positioning and stabilizing force FPSS may have to counteract both the attractive force Fg and the plenum chamber force Fplenum.

[0352] As shown in FIG. 6-1 , the attractive force Fg of the patient interface 3000 may be directed substantially parallel to the plenum chamber force Fplenum and / or the positioning and stabilizing force FPS. In this orientation, the patient may be in a reclining position (e.g., lying on their back). In this case, the attractive force Fg may be directed toward the patient's face (e.g., upper lip) and may counteract the plenum chamber force Fplenum. In other words, the positioning and stabilizing force FPS and the attractive force Fg may be directed toward the patient's face and counteract the plenum chamber force Fplenum. In other words, because the attractive force Fg acts as a complement to counteract the plenum chamber force Fplenum, a lower positioning and stabilizing force FPS may be required to hold the seal-forming structure 3100 in a sealed position (and achieve equilibrium).

[0353] As shown in FIG. 6-2, the attractive force Fg of the patient interface 3000 may be directed substantially perpendicular to the plenum chamber force Fplenum and / or the positioning and stabilizing force FPSS. In this orientation, the patient may be lying on their side. As noted above, the positioning and stabilizing force FPSS may have to counteract both the attractive force Fg and the plenum chamber force Fplenum. Also, the plenum chamber 3200 and / or the positioning and stabilizing structure 3300 may tend to be in compression on the underside, but in tension on the upper side.

[0354] In some forms (see, e.g., FIGS. 7 and 8 ), the positioning and stabilizing structure 6300 may include a woven tube 6350 having a left arm 6305 and a right arm 6307. The woven tube 6350 may be formed with a first side configured to contact the patient, which may be referred to as the inner layer 6352. The woven conduit may also include a second side, which is attached to the inner layer 6352 but faces away from the patient and may be referred to as the outer layer 6354. The inner and outer layers 6352 and 6354 may be secured to one another along their edges, respectively, such that a flow path or passageway is formed between the seams of the inner and outer layers 6352 and 6354. That is, the space between the seams remains unattached, forming the air passageway 6372. The inner layer 6352 and the outer layer 6354 may be joined using various techniques to impart specific attributes to the seam or joint. For example, in some embodiments, the seam is formed using ultrasonic welding, radio frequency welding, and cutting and welding techniques. The application of heat to specific areas activates thermosetting or thermoplastic materials used in the tube 6350. This heat may be used not only to bond the layers to one another, but also to thermoform layers, such as the outer layer 6354. Additionally, in some embodiments, bonding, such as stitching or adhesives, may be used to bond the layers to one another. In some embodiments, stitching is not used. In further embodiments, no material beyond that disposed within the layers is used to bond the inner layer 6352 and the outer layer 6354 of the tube. For example, in some embodiments, the inner layer 6352 and the outer layer 6354 may be formed such that no additional material, such as adhesives or stitching, is required to bond the inner layer 6352 and the outer layer 6354.

[0355] The inner layer 6352 and the outer layer 6354 can each include an inner surface and an outer surface. The inner surface of the inner layer 6352 is the surface facing the outer layer 6354. The inner surface of the outer layer 6354 is the surface facing the inner layer 6352. Similarly, the outer surface of the outer layer 6354 faces away from the inner layer 6352, and the outer surface of the inner layer 6352 faces away from the outer layer 6354. Furthermore, in embodiments including a single sheet, the inner surface is the surface of the sheet that is disposed inwardly or toward itself.

[0356] In some embodiments, the sheet or tube sheet may include an air impermeable layer or membrane. In some embodiments, the inner surface of both layers includes a membrane configured to restrict or inhibit air from passing through the layer from the inner surface to the outer surface. The impermeable layer may be a thin layer less than the thickness of the fabric sheet of the inner or outer layer. In other embodiments, the impermeable layer may exceed the thickness of the fabric sheet of either layer. The impermeable layer or membrane or film may be completely impermeable to air movement, or may be configured to allow a predetermined velocity or air movement and a specific pressure.

[0357] The membrane may be formed from a thermoplastic or thermosetting material such that when exposed to a particular temperature, the membrane material can be molded or formed into a particular shape and then hardened or solidified by cooling. In some forms, the membrane may be formed from silicone or polyurethane. In some forms, the outer layer 6354 is pre-formed such that, in an unpressurized or supported state, the outer layer 6354 is pre-positioned and pre-formed to extend away from the inner layer 6352 between opposing joints 6312. That is, the outer layer 6354 can support its own weight, so that the outer layer 6354 remains spaced apart from the inner layer 6352 between the joints 6312 even when not supported by pressurized air or other support mechanism.

[0358] In contrast, the inner layer 6352 can be a flexible component. When the inner layer 6352 is attached and secured to the edge of the outer layer 6354, the inner layer 6352 becomes a substantially planar layer.

[0359] As shown in Figure 8, and particularly as shown in Figure 9, the inner layer 6352 includes a fabric sheet 6360 with a membrane 6362. The fabric sheet 6360 may be formed from felt, foam, woven, knitted, or nonwoven material or other fibrous network.

[0360] The outer layer 6354 includes a tube sheet 6364 and an outer covering 6366. In some forms, both sides of the tube sheet 6364 can be covered with a membrane. As shown in FIG. 10 , the tube sheet 6364 includes a membrane 6368 exposed to the chamber of the tube 6350 and a membrane 6370 along the opposite side of the tube sheet 6364. The membrane 6368 can assist in providing a seal between the inner layer 6352 and the outer layer 6354 and forming an airtight tube. The membrane 6370 can assist in bonding the tube sheet 6364 to the outer covering 6366.

[0361] 5.3.2.4 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).

[0362] In certain forms, the vent 3400 is configured to allow continuous vent flow from the interior of the plenum chamber 3200 to the ambient when the pressure within the plenum chamber is positive relative to the ambient. 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.

[0363] 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).

[0364] The vent 3400 may be disposed within the plenum chamber 3200. The vent 3400 may include a plurality of holes as described above. The holes in the vent 3400 may be divided into two laterally spaced groups. The axes of the flow paths through each of the holes in the vent 3400 may be parallel, thereby avoiding cross-flow and further noise generation. The vent holes may be circular.

[0365] The radius of the holes in the vent 3400 may decrease from the inside to the outside of the plenum chamber 3200. Each vent hole has a draft angle. The diameter of each hole is smaller at the front end than at the rear end. The draft angle helps provide effective carbon dioxide extrusion at high humidification levels because the cross section of the hole does not decrease throughout the entire chassis thickness. Additionally, a larger draft angle may make the plenum chamber 3200 easier to manufacture (especially if the plenum chamber 3200 is formed from an injection-molded plastic material). The draft angle allows for the use of thicker vent pins in the mold and easier injection.

[0366] The holes in the vent 3400 may be provided in two sets towards the middle of the plenum chamber 3200, and the sets may be symmetrical across the centerline of the plenum chamber 3200. Providing multiple vent patterns may allow for noise reduction and may allow for dispersion of flow crowding.

[0367] The holes in the vent 3400 may be positioned an optimal distance away from the centerline of the plenum chamber 3200. Positioning the holes in the vent 3400 toward the centerline may be advantageous as it may reduce the likelihood of the vent becoming blocked when the patient is lying down. However, placing the holes too close to the middle of the plenum chamber 3200 may cause the plenum chamber 3200 to become excessively weak in the center, since the cross-section of the plenum chamber 3200 in the example described is smallest in the center (due to the overall shape of the plenum chamber 3200). The location of the holes in the vent 3400 may avoid blocking of the holes during lying down while still allowing the mid-section of the chassis to remain sufficiently rigid.

[0368] The size of each vent and the number of vents can be optimized to achieve a balance between noise reduction while achieving the necessary carbon dioxide push, even under extreme humidification. In the example shown, the vents in the vent 3400 do not provide the entire system's airflow. The decoupling structure 3500 can include a decoupling structure vent 3402. The decoupling structure vent 3402 can include one or more holes through the decoupling structure 3500. The decoupling structure vent 3402 can function to bleed off excess pressure generated by the RPT device 4000 (before it reaches the patient), while the vent 3400 can push out carbon dioxide exhaled by the patient during treatment.

[0369] In some examples, a vent insert (not shown) is removably or permanently attached to the plenum chamber 3200 at the vent insert opening. The vent insert may be constructed of a more flexible material than the material of the plenum chamber 3200. In one example, a heat and moisture exchange (HME) material (e.g., foam) is housed in the removable vent to humidify the air the patient inhales (without the need for a separate humidifier). The vent insert may be removable to allow the patient to replace the HME material (after a period of time) with a new, clean sheet of HME material. Additionally, the entire vent structure can be replaced (e.g., as opposed to the HME material alone).

[0370] 5.3.2.5 Uncoupling structure In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0371] The hub 3306 as described above is connected to a decoupling mechanism 3500, which in these examples is a rotatable elbow. The decoupling mechanism 3500 may be rotatable 360° within the hub 3306 in use. The decoupling mechanism 3500 may be removable from the hub 3306 by manually depressing a button 3504 which releases a catch (not shown) from within the hub 3306.

[0372] The decoupling structure 3500 may also include a swivel 3502 that allows for a rotatable connection to the air circuit 4170 .

[0373] The decoupling structure 3500 being rotatable, the decoupling structure 3500 taking the form of an elbow, and allowing the swivel 3502 to rotate on the decoupling structure 3500 can all lead to increased degrees of freedom, resulting in reduced tubing drag and torque on the patient interface 3000 due to connection to the air circuit 4170.

[0374] 5.3.2.6 Connection Port The connection port 3600 allows connection to the air circuit 4170 .

[0375] 5.3.2.7 Forehead support In one form, the patient interface 3000 includes a forehead support 3700 .

[0376] 5.3.2.8 Anti-asphyxiation valves In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0377] 5.3.2.9 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.

[0378] 5.3.3 Full face cushion 26-33, a patient interface 6000 includes a cushion assembly 6105 having a seal-forming structure 6100. The seal-forming structure 6100 is configured to separately seal around the patient's nares and mouth (e.g., an oral-nasal cushion assembly or a miniature full face mask). The cushion assembly 6105 is at least partially formed by the seal-forming structure 6100 and a plenum chamber 6200 attached to the plenum chamber according to an example of the present technology.

[0379] 22-25 and 34-39, a cushion assembly 9105 is illustrated. The cushion assembly 9105 is similar to the cushion assembly 6105 and has a seal-forming structure 9100. The seal-forming structure 9100 is configured to separately seal around the patient's nares and mouth (e.g., an oral-nasal cushion assembly or a miniature full face mask). The cushion assembly 9105 is at least partially formed by the seal-forming structure 9100 attached to a plenum chamber and a plenum chamber 9200 according to an example of the present technology.

[0380] The cushion assembly 9105 includes a nose region 9101, nose region holes 9103, a mouth region 9102, a mouth region hole 9104, a cavity 9001, a support structure 9120, a sealing portion 9130, and a vent portion 9400, which are similar to the features shown in Figures 26-33. The description of Figures 26-33 generally applies to Figures 22-25 and 34-39, and many of the similarities and differences will not be discussed separately. A pair of plenum chamber holes are configured to receive airflow.

[0381] The cushion assembly 9105 (e.g., in particular the nasal region 9101) may include at least one curved surface due to its connection to the support structure 9120. This curved surface may extend from the anterior to the posterior side of the cushion assembly 9105 (see, e.g., FIG. 24). A similar curvature may be provided to the cushion assembly 6105 (see, e.g., FIGS. 30 and 31). However, in contrast to the cushion assembly 6105, the cushion assembly 9105 (e.g., in particular the nasal region 9101) may include at least one curved surface. This may be obtained by crimping in the nasal region 9101, as will be described in more detail below (although the curved surface may also be formed without crimping using an elastomeric-only membrane). When the cushion assembly 9105 is in use, the curved surface of the cushion assembly 9105 resulting from the crimping may extend laterally (e.g., side-to-side) along the patient's face. For example, the curved surface of the cushion assembly 9105 resulting from the crimp may extend curvedly about an axis perpendicular to an axis passing through the cross-section line 36-36 (see, e.g., FIG. 34) and / or about a third axis 13000 (discussed in more detail below). The curved surface resulting from the crimp may also have a positive curvature relative to the patient's face.

[0382] As described with reference to FIGS. 23-24 , the positioning and stabilizing structure 9300 provides a force F PSS that maintains the cushion assembly 9105 in a sealing position on the patient's face. The positioning and stabilizing force F PSS can be a resultant force from various force vectors of different elements of the positioning and stabilizing structure 9300. For example, each conduit 9900 can provide a rearwardly and respective laterally directed force F conduit to hold the seal-forming structure 9100 against the patient's face and counter the effect of positive pressure in the plenum chamber 9200 (e.g., F plenum ) to lift the seal-forming structure 9100 off the face. The directed force F conduit can also be directed at least partially upwardly to overcome the gravitational force F g . The positioning and stabilizing force F PSS can also include a force F L S from the lower strap 9303 (e.g., directed substantially rearward) and / or a force F US from the upper strap 9302 (e.g., directed substantially rearward and downward).

[0383] The generation of the attractive force Fg within the patient interface 9000 may similarly vary depending on the orientation of the patient wearing the patient interface 9000, as shown in Figures 6-6-2. As described with respect to Figures 6-6-2, the positioning and stabilizing force FPSS may be set so that the patient interface 9000 has a net zero force (i.e., so that all forces cancel out). The tightness of the lower strap force FLS and / or upper strap force FUS may depend on the patient's preferred sleeping orientation.

[0384] As noted above, the patient may experience frictional forces due to contact with various components of the patient interface 9000. As shown in Figures 23 and 24, a frictional force Ff is shown opposing the attractive force Fg of the seal-forming structure 9100 and plenum chamber 9200. Other components of the overall frictional force are not shown, but they oppose other forces acting on the patient interface 9000. Because the patient interface 9000 is a full-face cushion, the frictional force Ff, which opposes the attractive force Fg of the seal-forming structure 9100 and plenum chamber 9200, is exerted over a larger surface area. For example, in addition to the upper lip, the illustrated frictional force Ff may act on the lower lip and / or nasolabial fold, among other areas.

[0385] As noted above, Figures 37-39 show grip pads 9150 on the surface of the textile membrane. The grip pads 9150 may be provided on the first sealing portion 9131 and / or the second sealing portion 9132. Although shown with the cushion assembly 9105, the grip pads 9150 may also be used within the cushion assembly 6105.

[0386] 33-1 , the patient interface 21000 includes a cushion assembly 21105 with a seal-forming structure 21100. The seal-forming structure 21100 is configured to seal around the patient's nares and mouth (e.g., an oral-nasal cushion assembly or a miniature full face mask). The cushion assembly 21105 is similar to cushion assemblies 6105 and 9105. The cushion assembly 21105 is at least partially formed by the seal-forming structure 21100 attached to a plenum chamber and a plenum chamber 21200 according to an example of the present technology. The seal-forming structure 21100 may also include a contoured surface, such as the nasal region 9101.

[0387] 33-2, the patient interface 23000 includes a cushion assembly 23105 with a seal-forming structure 23100. The seal-forming structure 23100 is configured to seal around the patient's nares and mouth (e.g., an oral-nasal cushion assembly or a miniature full face mask). The cushion assembly 23105 is similar to cushion assemblies 6105 and 9105. The cushion assembly 23105 is at least partially formed by the seal-forming structure 23100 attached to a plenum chamber and a plenum chamber 23200 according to an example of the present technology. The seal-forming structure 23100 may also include a contoured surface such as the nasal region 9101.

[0388] 33-3 to 33-11, the patient interface 25000 includes a cushion assembly 25105 with a seal-forming structure 25100. The seal-forming structure 25100 is configured to seal around the patient's nares and mouth (e.g., an oral-nasal cushion assembly or a miniature full face mask). The cushion assembly 25105 is similar to cushion assemblies 6105 and 9105. The cushion assembly 25105 is at least partially formed by the seal-forming structure 25100 attached to a plenum chamber and a plenum chamber 25200 according to an example of the present technology. The seal-forming structure 25100 may also include a contoured surface, such as the nasal region 9101.

[0389] The full face cushion of Figures 22-39 may bear certain similarities to the nasal cushion 3000 described above. For example, the seal-forming structure, described in more detail below, may have tension selectively applied to assist in the formation of a resulting shape (e.g., a two-dimensional or three-dimensional shape). Various similarities and differences between the full face cushion and the nasal cushion 3000 are described below. Additionally, various features of the woven full face cushion described below are applicable to full face cushions with elastomer-only membranes.

[0390] 5.3.3.1 Plenum chamber The plenum chamber 6200 has edges shaped to complement the surface contours of an average human face in the area where a seal is formed in use. In use, the periphery of the plenum chamber 6200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 6100. The seal-forming structure 6100 may extend around the entire periphery of the plenum chamber 6200 in use.

[0391] In certain forms of the present technology, the plenum chamber 6200 is constructed from a relatively stiff material (e.g., polycarbonate) compared to the seal-forming structure 6100. In another example, the plenum chamber 6200 may be constructed from a flexible material (e.g., silicone, woven fabric) and have a similar stiffness to the seal-forming structure 6100. In another example, the plenum chamber 6200 may be constructed from a transparent material (e.g., clear polycarbonate). The use of a transparent material may reduce the intrusiveness of the patient interface 6000 and may assist in improving compliance with treatment. The use of a transparent material may assist the clinician in verifying the placement and function of the patient interface 6000 and / or observing the accumulation of debris (e.g., dust, dirt, mold, etc.).

[0392] In certain forms of the present technology, the plenum chamber 6200 is constructed from a translucent material. The use of a translucent material can make the patient interface 6000 less intrusive and can help improve compliance with treatment.

[0393] The plenum chamber 6200 according to examples of the present technology may include a plenum chamber hole on each lateral side (e.g., to the left and right of the bridge portion 6106 in FIG. 26 ). The plenum chamber holes may provide pneumatic communication between the conduit connector 6800 (described in more detail below) and the cavity 6001. A connecting rim around each plenum chamber hole may facilitate a mechanical connection (e.g., a snap or friction fit) with the respective conduit connector. The plenum chamber 6200 may be constructed of a sufficiently rigid material to provide auditory and / or tactile feedback to the patient when the conduit connector 6800 is connected to or disconnected from the plenum chamber 6200.

[0394] The seal-forming structure 6100 may be sealingly connected to the plenum chamber 6200. The connection may be permanent, or the seal-forming structure 6100 may be removable from the plenum chamber 6200. The seal-forming structure 6100 may be molded (e.g., overmolded, injection molded, etc.) to the plenum chamber 6200. The seal-forming structure 6100 and the plenum chamber 6200 are joined by a mechanical connection. In a mechanical connection, no chemical bond is formed between the plenum chamber 6200 and the seal-forming structure 6100.

[0395] 5.3.3.2 Seal formation structure 26-33, the seal-forming structure 6100 may include a nose portion 6101 having at least one aperture (e.g., a pair of nostril openings 6103) for sealing against and delivering pressurized air to the patient's nares. In the illustrated embodiment, two separate apertures 6103 are provided, each corresponding to one of the patient's nares, to provide airflow to both of the patient's nares. A bridge portion 6106 may be provided between the nostril openings 6103. In an alternative embodiment, a single aperture may be used to provide airflow to both of the patient's nares. In a further alternative embodiment, three or more apertures may be provided. In contrast to the bridge portion 3104, the bridge portion 6106 cannot be selectively tensioned. For example, rather than tensioning only the bridge portion 6106, the surrounding material of the bridge portion 6106 and the nose portion 6101 may both be held under tension.

[0396] 22-25 and 34-39, bridge region 9106 may be selectively tensioned in a manner similar to bridge region 3104. For example, bridge region 9106 may be in more tension than the surrounding first seal portion 9131.

[0397] 26-33, the seal-forming structure 6100 can include a mouth region 6102 having a mouth region aperture 6104 for sealing against a patient's mouth. In some examples, the mouth region 6102 is at least partially tensioned (e.g., in any number of discrete locations) when not in use (i.e., when not in contact with a patient's face). For example, the mouth region can be tensioned at the junction with the support structure 6120, while being relaxed on exposed sealing edges (e.g., the inner edge adjacent the opening of the cavity 6001). In some examples, the entire mouth region 6102 is relaxed when not in use. In any of these examples, contact with a patient's face can cause the mouth region 6102 to stretch and be under tension when in use.

[0398] The seal-forming structure 6100 may at least partially form a cavity 6001 that is pressurized by the air flow. The plenum chamber 6200 may join with the seal-forming structure 6100 to further form the cavity 6001.

[0399] The seal-forming structure 6100 may include a support structure 6120 that provides support to a sealing portion 6130 (e.g., a woven membrane). The sealing portion is configured to sealingly engage with the patient's face. The sealing portion 6130 is sufficiently large (e.g., curved a sufficient amount in the anterior direction) so that only the sealing portion 6130 (e.g., only the woven membrane) contacts and sealingly engages with the patient's face. Alternatively, the support structure 6120 may be constructed of a woven material.

[0400] In one example, the seal-forming structure 6100 may include a support structure 6120 having at least two regions (e.g., two, three, or four regions) of different thicknesses (e.g., the seal-forming structure 6100 has a wall structure with thicker lateral support regions (compared to other portions of the wall structure)) (see, e.g., 3122 in FIGS. 58 and 59). For example, as shown in FIGS. 58 and 59, some portions 3123 of the support structure 3120 may be thicker than portions 3124, 3126 of the support structure 3120. For example, the thicker portion 3123 may be adjacent to or connect to the plenum chamber, and portions 3124, 3126 may be adjacent to or connect to the woven membrane 3130, thereby providing structural stability at the connection with the plenum chamber 3200 and flexibility at the interface with the patient. Alternatively, the thicker portions of the lateral support region 3122 may be positioned, for example, at the corners of the nasal region of the seal-forming structure (e.g., directly connected to the fabric membrane) to ensure proper sealing in the alar region of the patient's face.

[0401] As described above, the seal-forming structure 6100 may be sealingly connected to the plenum chamber 6200. The support structure 6120 may be less rigid than the plenum chamber 6200 and may be constructed from silicone, foam (e.g., polyurethane foam), polyurethane solid material, thermoplastic elastomer (e.g., thermoplastic polyurethane), suitable plastic, or other suitable material as described below. Additionally, the seal 6130 may be less rigid than the support structure 6120 and may be constructed from a woven material 6130 (e.g., nylon, polyester, nylon and polyester blends, microfiber, or polyurethane, for example, as described in more detail below).

[0402] In the example of FIG. 32, the support structure 6120 may extend into the cavity 6001 forming a lower cushion 6121 that provides support to the sealing portion 14130. The lower cushion 6121 and the sealing portion 6130 may form a double-wall structure around the sealing portion. In alternative examples, a second or third lower cushion layer may be provided to form a triple- or quadruple-wall structure. In the example of FIG. 32, the lower cushion is constructed of a foam material (e.g., polyurethane foam). In alternative examples, the lower cushion 6122 may be constructed of silicone as shown in FIG. 33. However, it will be appreciated that the lower cushion may be constructed of other suitable materials (e.g., fabric).

[0403] The sealing portion 6130 may be constructed from two different pieces of textile membrane (or alternatively, an elastomeric-only membrane). For example, one piece 6131 may be used to seal around the patient's nose, while a separate piece 6132 may be used to seal around the patient's mouth. The sealing portions 6131, 6132 may be used to seal around each orifice independently. In other words, the first or upper sealing portion 6131 may not contact the area around the patient's mouth, and the second or lower sealing portion 6132 may not contact the area around the patient's nose.

[0404] As shown in Figures 26-33, the first sealing portion 6131 is located at the top (i.e., in use) of the patient interface 6000 relative to the second sealing portion 6132. The first sealing portion 6131 forms a rounded (e.g., generally triangular oval) perimeter to seal around the patient's nares in use.

[0405] In some forms, the first sealing portion 6131 may contact the area between the ala of the nose and the upper lip, leaving the nasal tip exposed (see, for example, FIGS. 23-25, which show a similar first sealing portion 9131). The fabric membrane of the first sealing portion 6131 may be the only material of the seal-forming structure 6100 that contacts the patient in this area. In other words, the second sealing portion 6132 and the support structure 6120 do not contact the patient in this area. This may assist in improved patient compliance, as the patient may only come into contact with a fabric layer (of the patient's more proximal bedding (rather than the medical device)) in this area of ​​their face.

[0406] The second sealing portion 6132 is positioned underneath (i.e., relative to the first sealing portion 6131 of the patient interface 6000 in use). In the illustrated example, the second sealing portion 6132 forms a generally U-shape and seals around a portion of the patient's mouth. The fabric membrane forming the second sealing portion 6132 does not extend all the way around the patient's mouth. In other words, when forming a seal around the patient's mouth, material other than the fabric membrane may come into contact with the patient. In this example, to complete the mouth area opening 6104, a support structure 6120 (e.g., a silicone material) is molded between the free ends of the second sealing portion 6132. The fabric membrane of the second sealing portion 6132 may contact the patient's lower lip, the area outside the corners of the patient's mouth, and a portion of the patient's upper lip, but may not contact the center of the patient's upper lip (e.g., near the patient's philtrum). The support structure 6120 extends across the patient's philtrum between the ends of the second sealing portion 6132. The combination of the fabric membrane of the sealing portion 6130 and the silicone material of the support structure 6120 may function to create a seal around the patient's mouth.

[0407] The support structure 6120 extends from the underside of the first sealing portion 6131 to the opening of the cavity 6001. In other words, the first sealing portion 6131 is separated from the second sealing portion 6132 by the support structure 6120. The material of the support structure 6120 (e.g., silicone) also assists in interconnecting the first sealing portion 6131 and the second sealing portion 6132 during the manufacturing process.

[0408] As shown in FIG. 33-1 , the second sealing portion 21130b extends around the entire periphery of the patient's mouth. In other words, the fabric membrane contacts the philtrum, in contrast to the support structure 21120. The support structure 21120 (e.g., a silicone material) is disposed in an inferior / superior direction between the first sealing portion 21130a and the second sealing portion 21130b (e.g., between the first subsection and the second subsection). While the support structure 21120 may make some contact with the patient's upper lip, sealing is achieved primarily or exclusively through the fabric membranes in the first sealing portion 21130a and the second sealing portion 21130b. In other words, the location where the support structure 21120 contacts the patient's skin may not be under pressure and / or may be exposed to the environment during treatment. Extending the second support structure 21130b around the patient's mouth may provide increased patient comfort (e.g., because the patient may find the woven membrane more comfortable than silicone) compared to a U-shaped second sealing structure 21130b, which may result in improved patient compliance. However, a thin, elastomer-only membrane may substantially replicate the comfort of a woven membrane, so patient compliance is not substantially altered while using a substantially thin membrane.

[0409] In another example of the patient interface 23000, as shown in FIG. 33-2, the second sealing portion 23132 is U-shaped. However, the philtrum and central portion of the upper lip contact the fabric membrane. In this example, the first sealing portion 23131 extends downward to the edge of the mouth opening 23104. In other words, the first sealing portion 23131 functions to form a seal around the patient's nose and also partially functions to form a seal around the patient's mouth. The U-shaped second sealing portion 23132 extends substantially around the remainder of the patient's mouth (although a small portion of the support structure 23120 is disposed laterally left and right between the first sealing portion 23131 and the second sealing portion 23132). This example may provide similar comfort benefits as those described above for FIG. 33-1 (e.g., because substantially all of the contact between the patient interface 23000 and the patient's nose and mouth is through the fabric membrane). However, the example of FIG. 33-2 may be easier to manufacture because the support material 23120 between the first sealing portion 23131 and the second sealing portion 23132 has been removed in the superior / inferior direction. A small portion of the support structure 23120 between the sealing portions 23131 and 23132 may assist in creating a pressurized volume around the patient's mouth.

[0410] In other examples of the patient interface 25000, as shown in FIG. 33-3 , the sealing portions 25131, 25132 are formed from a single piece of woven material. In other words, the first sealing portion 25131 and the second sealing portion 25132 are not constructed from separate pieces of material. The single piece of material forming the sealing portions 25131, 25132 functions to form a seal around both the patient's nose and the patient's mouth. The sealing portions 25131, 25132 may have perimeters similar to those described above (e.g., in the example of the patient interface 25000 having first and second sealing portions 25131, 25132). In some examples, the sealing portions 25131, 25132 may be sealed only at the perimeter, as failure to seal against the patient's upper lip may lead to air leakage from the seal-forming structure 25100. However, the seals 25131, 25132 may seal against the patient's upper lip so that pressurized air is delivered more directly to the patient's airway. By using a single woven membrane piece to form the seals 25131, 25132, the support structure 25120 does not have to come into contact with the patient's upper lip. Furthermore, the patient interface may be easier to manufacture because a thin strip of support structure 25120 does not need to be formed between and connect two woven membrane pieces. This simplifies the molding process and also eliminates the need for a small amount of material, such as silicone, to be poured between and cover the woven layer 10133.

[0411] As shown in Figures 22-25 and 31-1-39, each seal-forming structure may have a three-dimensional shape. Specifically, each first sealing portion may have a curved surface (e.g., in the left-right direction) as opposed to the flat surface (e.g., in the left-right direction) shown in Figures 26-33. The three-dimensional shape may be formed at least in part by selectively tensioning the bridge portion of each first sealing portion. The first sealing portion material surrounding the bridge portion on each seal-forming structure is not tensioned such that the first sealing portion includes a curved shape.

[0412] In all of these embodiments (e.g., FIGS. 22-39), the seal strength against the patient's face is substantially the same. For example, using a fabric material alone or a combination of fabric and silicone materials does not substantially affect the quality of the seal (i.e., increase or decrease the leakage area). Different patients (e.g., different face geometries) may be more suitable in one particular example than in another (e.g., due to comfort, fit). Furthermore, while greater fabric coverage may provide additional patient comfort, the increase in comfort may be minimal (e.g., in the case of the support structure 6120, due to minimal contact with both the first sealing portion 6131 and the second sealing portion 6132).

[0413] 5.3.3.3 Positioning and stabilizing structures The seal-forming structure 9100 of the patient interface 9000 of the present technology may be held in a sealed position during use by the positioning and stabilizing structure 9300. In particular, although the positioning and stabilizing structure 9300 is illustrated with the patient interface 9000, the positioning and stabilizing structure 9300 may be used with any of the full face cushions (e.g., any of the examples in Figures 22-39). The positioning and stabilizing structure 9300 may also be similar to the positioning and stabilizing structure 3300.

[0414] In one form, the positioning and stabilizing structure 9300 provides at least enough holding force to overcome the effect of positive pressure in the cavity 9001 to lift off the face.

[0415] In one form, the positioning and stabilizing structure 9300 provides a holding force sufficient to overcome the attractive force on the patient interface 9000.

[0416] In one form, the positioning and stabilizing structure 9300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 9000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0417] In one form of the present technology, there is provided a positioning and stabilizing structure 9300 configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure 9300 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 9300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilizing structure 9300 includes at least one flat strap.

[0418] In one form of the present technology, a positioning and stabilizing structure 9300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a supine sleeping position with the posterior region of the patient's head resting on a pillow.

[0419] In one form of the present technology, a positioning and stabilizing structure 9300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleeping position with the side regions of the patient's head resting on pillows.

[0420] In one form of the present technology, the positioning and stabilizing structure 9300 comprises a decoupling site located between an anterior section of the positioning and stabilizing structure 9300 and a posterior section of the positioning and stabilizing structure 9300. 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 with their head on a pillow, the presence of the decoupling site prevents forces from being transmitted along the positioning and stabilizing structure 9300 to the posterior section, disrupting the seal.

[0421] In one form of the present technology, the positioning and stabilizing structure 9300 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 is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion. In one form, a conduit 9900 for air delivery to the cushion assembly 9105 can also comprise the positioning and stabilizing structure 9100.

[0422] In certain forms of the present technology, the positioning and stabilizing structure 9300 includes a stretchable (e.g., stretchable with elasticity) strap. For example, the strap can be configured to be tensioned in use to direct a force that forces the seal-forming structure into intimate contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0423] In one form of the present technology, the positioning and stabilizing structure may include a first tie (e.g., upper strap 9302 (FIG. 24)) constructed and arranged such that in use at least a portion of its lower edge passes over and moves to a superior-ear-base point on the patient's head.

[0424] In one form of the present technology that is suitable for a full face mask, the positioning and stabilizing structure includes a second tie (e.g., lower strap 9303 (FIG. 24)) that is constructed and arranged such that, in use, at least a portion of its upper edge passes under the inferior ear base point on the underside of the patient's head and covers or rests under the occipital bone of the patient's head.

[0425] 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 (e.g., strap connector 9304 (FIG. 22)) constructed and arranged to interconnect the first tie and second tie in a manner that reduces the tendency of the first tie and second tie to move apart.

[0426] In certain forms of the present technology, the positioning and stabilizing structure 9300 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.

[0427] In a particular form of the present technology, the positioning and stabilizing structure 9300 includes straps configured to be breathable to allow water vapor to pass therethrough.

[0428] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 9300. Each positioning and stabilizing structure is configured to provide a holding force to accommodate a different size and / or shape range. For example, the system may include one form of positioning and stabilizing structure 9300 that is suitable for large sized heads but not small sized heads, and another form that is suitable for small sized heads but not large sized heads.

[0429] The positioning and stabilizing structure 9300 may include a clip 9301 for securing each tie to the conduit connector 9800, for example as shown in Figure 22. The clip 9301 and the conduit connector 9800 each have magnets disposed thereon with opposite polarities to facilitate connection therebetween.

[0430] 5.3.3.4 Ventilation In one form, the patient interface 6000 includes a vent 6400 constructed and arranged to allow the expulsion of exhaled gases (eg, carbon dioxide), as shown in FIG.

[0431] In certain forms, the vent 6400 is configured to allow continuous vent flow from the interior of the plenum chamber 6200 to atmosphere when the pressure in the plenum chamber is positive relative to atmosphere. The vent 6400 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 in the plenum chamber in use.

[0432] Ventilation section 6400 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).

[0433] The vent 6400 may be located within the plenum chamber 6200. Alternatively, the vent 9404 is located within a decoupling structure, such as a swivel (see FIG. 22).

[0434] The conduit connector 6800, described in more detail below, may also include a venting feature.

[0435] 5.3.3.5 Uncoupling structure In one form, the patient interface 9000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0436] 5.3.3.6 Connection Port The connection port 6600 allows for connection to the tube 6348 of the air circuit 4170 (see FIG. 7). A connection port 9600 in accordance with an embodiment of the present technology may be connected to a connection port housing 9903 (see FIG. 22). The connection port 9600 may be swivelable relative to the connection port housing 9903, and the connection to the air circuit 4170 may also be swivelable.

[0437] The connection port 9600 and connection port housing 9903 may be positioned above the patient's head in use.

[0438] 5.3.3.7 Forehead support 22-39 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.

[0439] 5.3.3.8 Conduit A patient interface 9000 according to embodiments of the present technology may include a conduit 9900 for supplying pressurized air flow from the connection port 9600 to a cavity 9001 in the plenum chamber 9200. The conduit 9900 may be similar to the lateral and upper portions 3302 and 3304 of FIG. 6 and the tube 6350 of FIG. 7. The conduit 9900 may be joined above the patient's head at the connection port housing 9903 and may pass along the side of the patient's head between corresponding ones of the patient's eyes and ears. The conduit 9900 may be connected to the cushion assembly 9105 (e.g., plenum chamber 9200) via a conduit connector 9800 to provide pressurized air flow to the cavity 9001, as described below.

[0440] The conduit 9900 may also allow for stabilization and positioning of the seal-forming structure 9100 on the patient's face. Thus, the conduit 9900 may function similarly to a tie in the positioning and stabilizing structure 9300. Thus, the mechanical connection from the conduit 9900 to the conduit connector 9800 may be sufficient to transfer tensile forces in the conduit 9900 through the conduit connector 9800 to the seal-forming structure 9100.

[0441] The conduit 9900 may include features of similar conduits disclosed in International Application Publication No. WO 2017 / 124155 A1, which is incorporated herein by reference in its entirety. For example, the conduit 9900 of the present technology may include features of the headgear tube 3350 described in Figures 3A-3L and related description of that document.

[0442] The conduit 9900 may be provided with a sleeve 9901 to cushion and protect the patient's face from the conduit 9900. The sleeve 9901 may be removable. The sleeve 9901 may be made of a breathable material.

[0443] The conduit 9900 may also include a tie connector 9902 to facilitate connection with a tie of the positioning and stabilizing structure 9300.

[0444] 5.3.3.9 Conduit Connectors 26-33, the patient interface 6000 may include several views of conduit connectors 6800 of the patient interface 6000 in accordance with embodiments of the present technology. The conduit connectors may connect a conduit to the cushion assembly 6105 to provide pressurized air flow to the cavity 6001. These conduit connectors 6800 may be similar to the conduit connectors 9800 (see, for example, FIGS. 22-25), and the following description may apply equally to the conduit connectors 9800.

[0445] Each conduit connector 6800 may be formed with a conduit connector housing 6801. The conduit connectors 6800 may provide other functions as described below (e.g., venting the plenum chamber 6200, connection to positioning and stabilizing structures, and preventing asphyxiation through the inclusion of an anti-asphyxiation valve 6850).

[0446] 26-33 illustrate conduit connectors 6800 attached to the plenum chamber 6200 at plenum chamber apertures (see, e.g., similar plenum chamber aperture 9210). As can be appreciated, one conduit connector 6800 is provided on each lateral side of the cushion assembly 6105, with each conduit connector 6800 connected to a plenum chamber aperture on a corresponding lateral side of the cushion assembly 6105. Each of the conduit connectors 6800 can include conduit connector mounting structure for connecting each of the conduit connectors 6800 to a respective plenum chamber aperture at a connecting rim (not shown). This connection can be mechanical (e.g., snap-fit ​​or friction-fit). This connection can also be detachable. The materials of the conduit connectors 6800 and the plenum chamber 6200 can each be selected to facilitate the desired connection features. For example, the material of the conduit connector 6800 and the material of the plenum chamber 6200 may each be relatively rigid to enable auditory and / or tactile feedback in connection with the snap fit. The material of the conduit connector 6800 and the material of the plenum chamber 6200 may be different in at least one embodiment, or the materials may be the same. The conduit connector 6800 may be permanently connected to the plenum chamber at the plenum chamber hole. For example, the conduit connector 6800 may be ultrasonically welded to the plenum chamber 6200. The connection between the conduit connector 6800 and the plenum chamber 6200 may be removable or permanent and may also be designed to be robust enough to transmit tension from the conduit to the plenum chamber 6200 (without disturbing the connection). This is because, as described above, the conduit connector 6800 may facilitate positioning and stabilizing the seal-forming structure 6100 on the patient's head.

[0447] The conduit connector 6800 may be attached to a lateral side of the plenum chamber 6200 to improve the aesthetics of the patient interface 6000. As noted above, constructing the plenum chamber 6200 from a transparent or translucent material may allow for visibility of the patient's facial features. For example, by positioning the conduit connector 6800 laterally of the plenum chamber as shown in the illustrated embodiment, a greater view of the patient's face is achieved, and this arrangement allows for improved aesthetics of the patient interface 6000. This is in contrast to alternative designs where the elbow and air circuit may be joined to the center of the plenum chamber 6200, thereby obstructing the patient's face.

[0448] Each conduit connector 6800 may also include a conduit connection end 6802 that connects to a respective conduit (e.g., similar to conduit 9900 in FIG. 22 ). The connection between the conduit and the conduit connector 6800 at the conduit connection end 6802 may be removable or permanent. A conduit connector inlet hole 6803 may be formed in the conduit connector housing 6801 at the conduit connection end 6802 to receive a flow of pressurized air. The conduit connector 6800 may include structure (e.g., an undercut) to facilitate a removable snap-fit ​​connection with a corresponding conduit. Each conduit may include a relatively rigid structure at its end that connects to the conduit connector 6800 to facilitate such a connection. The conduit connector 6800 may mate to the conduit by a friction fit, a snap fit, or any similar fit. Again, as described above, the conduit provides positioning and stabilizing functions for placing the seal-forming structure at a therapeutically effective sealing position on the patient's face, thereby ensuring a sufficiently secure connection between the conduit and the conduit connector 6800 at the conduit connection end 6802 to allow the transmission of tensile forces from the conduit to the conduit connector 6800 (without interfering with the connection between the conduit and the conduit connector 6800 at the conduit connection end 6802).

[0449] 29, the conduit connector 6800 may also provide a venting function for the patient interface 6000. The conduit connector housing 6801 may include a vent inlet that is in pneumatic communication with the cavity 6001 when the patient interface 6000 is assembled. The conduit connector housing 6801 may also include at least one conduit connector vent 6831. As can be seen in the illustrated embodiment, each conduit connector housing 6801 includes multiple conduit connector vents 6831. This allows for proper mixing of newly introduced air with the air already in the plenum chamber 6200, which can improve carbon dioxide displacement and increase the amount of fresh air provided to the patient for breathing.

[0450] As shown in Figures 22-24, a similar conduit connector 9800 may provide connection to the ties of the positioning and stabilizing structure 9300. The lower tie may be joined to the conduit connector 9800 by a clip 9301. The clip 9301 and conduit connector 9800 may include magnets of opposite polarity to facilitate connection. The connection between the tie of the positioning and stabilizing structure 9300 and the conduit connector 9800 may be releasable. Tension from the lower tie of the positioning and stabilizing structure 9300 may urge a lower portion of the seal-forming structure 9100 into sealing engagement with the patient's face (e.g., around the mouth). Alternatively, the connection structure to the clip 9301 may be formed directly on the conduit connector housing.

[0451] 5.3.3.10 Anti-asphyxiation valve In one form, the patient interface 6000 includes an anti-asphyxiation valve. As best shown in FIGS. 30 and 31, each conduit connector 6800 may include an anti-asphyxiation valve assembly 6850. Thus, the patient interface 6000 may include two anti-asphyxiation valve assemblies 6850. Each anti-asphyxiation valve assembly 6850 may operate independently of the other (i.e., in response to cessation of pressurized air flow). For example, if the pressurized air flow is stopped while the patient is sleeping on their side and one anti-asphyxiation valve assembly 6850 is blocked (e.g., by a pillow), the other anti-asphyxiation valve assembly 6850 can function to prevent the patient from asphyxiating. Although not explicitly shown, the patient interfaces of FIGS. 22-25 and 33-1-39 may also include at least one anti-asphyxiation valve.

[0452] 5.3.3.11 Port In one form of the present technology, the patient interface 6000 includes one or more ports that allow access to the volume within the plenum chamber 6200. In one form, this allows a clinician to provide supplemental oxygen. In one form, this allows direct measurement of a property of the gas (e.g., pressure) within the plenum chamber 6200. While not explicitly shown, the patient interfaces of FIGS. 22-25 and 33-1-39 may also include at least one port.

[0453] 5.3.4 Support structure and enclosure arrangement The support structures and closures of the above examples can have a number of different configurations and arrangements.

[0454] In use, sealing contact between the seal 3130 (e.g., textile membrane) and the patient's face may be maintained by: 1) the reaction stress of the support structure 3120; 2) the pre-formed state of the textile membrane 3130, which is untensioned and formed as a substantially constant surface without leaks that could cause obstructions in the textile membrane 3130 (e.g., wrinkles, folds, buckling, or fine lines); and / or 3) air pressure within the cavity against the interior surface of the seal 3130. Each of these factors may contribute to the seal 3130 conforming to the anthropometric contours of the patient's face, thereby minimizing wrinkles or ruptures and maximizing the contact area of ​​the seal 3130. Tension in the seal 3130 may increase due to any of these factors, but if the associated factor is removed, the seal 3130 may return to a relaxed state.

[0455] In some examples, the sealing portion 3130 may comprise a relatively thin, compliant, and extensible elastic material (e.g., a woven membrane comprising a suitable woven material (e.g., nylon, polyester, nylon and polyester blends, microfiber, or polyurethane)). The sealing portion 3130 may be molded or otherwise attached (e.g., glued, adhesively) to the support structure 3120, thereby eliminating wrinkles in the sealing portion 3130 material. This may be advantageous because it ensures that the sealing portion forms a smooth, continuous seal on the patient's face (without any folded sections that could cause air leaks). Additionally, the sealing portion 3130 may be shaped or imparted with curvature. Curvature may also be imparted to the sealing portion 3130 from the support structure 3120. In the illustrated example, the sealing portion 3130 may include curvature about multiple axes. This may assist the sealing portion 3130 in contouring to the complex facial anatomy of different patients.

[0456] 12-21, the sealing portion 3130 may have a concave curved profile (e.g., a positive dome curvature in the left-to-right direction) from one lateral side (right) to the opposite lateral side (left) to cradle the patient's nose when the patient interface 3000 is worn. In other words, the curvature of the sealing portion 3130 is positive relative to where the patient's bridge of the nose and / or subnasal point contacts the sealing portion 3130.

[0457] In some configurations, as shown in FIGS. 11-39, for example, the patient's nose is not intended to be received within the cavity 3101 formed by the plenum chamber 3200 and the seal-forming structure 3100. Instead, in contrast to conventional masks, the patient's nose is intended to be pressed against the woven membrane 3130, so that the woven membrane 3130 conforms to the contours of the patient's face and comfortably forms a reliable seal with the patient's airway. The woven membrane 3130 may stretch to conform to the patient's face. Specifically, the woven membrane 3130 in FIGS. 11-21 and in FIGS. 31-1-39 may be held in a relatively relaxed state (i.e., untensioned) prior to contact with the patient. When the patient contacts the woven membrane 3130 (e.g., through their nose), the compliant and compliant nature of the membrane causes the seal-forming structure 3100 to form against the patient's face (e.g., the patient's nose). In other words, as tension is applied to the woven membrane 3130 upon contact with the patient's face, it forms a complimentary shape to the patient's nose. Allowing the seal-forming structure 3100 to relax in its initial configuration may allow for improved contouring to the patient's face (than if the seal-forming structure 3100 were initially under tension) due to fewer areas that must undergo shape change. In some examples, the bridge regions 3104 may function to eliminate a central opening in the woven membrane 3130, thereby assisting in providing a seal that presses against the patient's nose instead of receiving it within the cavity 3101. The bridge regions 3104 may provide areas where tension applied from the patient to the woven membrane 3130 allows the seal-forming structure 3100 to conform and / or fit snugly against the patient's facial features (e.g., to limit and / or prevent leakage). This may also provide a different sealing experience as opposed to traditional masks. Such a sealing experience may provide greater comfort due to contact with the compliant textile membrane 3130 than conventional masks made of stiffer materials (where the sealing portion 3130 has a smaller contact area around the nose and / or mouth) or conventional sealing arrangements.The bridge region 3104 (or any region that is selectively tensioned) may provide a location where tensioning from the patient to the woven membrane 3130 may occur (regardless of whether the bridge region 3104 is positioned adjacent to at least one hole).

[0458] The woven membrane 6130 (e.g., the first sealing portion 6131) may be held in a relatively taut state (e.g., the first sealing portion 6131 may be under continuous tension) prior to contact with the patient. When the patient contacts the woven membrane 6130 (e.g., via their nose), the compliant, extensible properties cause the seal-forming structure 6100 to form against the patient's face (e.g., the patient's nose). In other words, contact with the patient's face applies additional tension to the woven membrane 6130, forming a complementary shape to the patient's nose. The entire first sealing portion 6131 may function in a manner similar to the bridge region 3104 described above, in that application of tension from the patient to the woven membrane 6130 (e.g., to limit and / or prevent leakage) may provide a location where the seal-forming structure 6100 will snug and / or fit snugly against the patient's facial features. While the woven membrane 6130 is in a taut state, the material may be sufficiently compliant or extensible that further tensioning may allow the material to conform to the patient's facial features. The combination of pre-tensioning at the first sealing portion 6131 and the pressurized seal obtained from the pressurized air flow may result in a stronger seal compared to a seal using only the pressure obtained from the pressurized air flow (e.g., as in patient interfaces 3000, 9000, 21000, 23000, 25000).

[0459] Compared to conventional silicone membranes and compressed foam seals, the seal 3130 in some of the present examples has a more flexible structural stiffness, which provides dynamic springback properties, allowing the seal 3130 to recover more quickly (when disturbed by an external force). Additionally, due to the lower structural stiffness, less sealing force is required, making the seal 3130 more comfortable and reducing facial scarring during use.

[0460] The woven membrane 3130 may exhibit variable tension across the material (e.g., lower tension near the nostril openings 3102 or more stretched material). The center of the woven membrane 6130 may be unsupported or slightly relaxed compared to the periphery of the woven membrane 6130, so the woven membrane 6130 may be under less tension near the nostril openings 6103. In some forms, the material surface of the seal that contacts the patient's face (e.g., 3130) may have low friction characteristics (e.g., a low friction finish), which may be advantageous as it may lead to improved material conformance with the patient's face while improving patient comfort.

[0461] The woven membrane 3130 may exhibit a variable tensile force across the material (e.g., a higher tensile force near the bridge region 3104). The woven membranes 9130, 21130, 23131, 23132, 25131, 25132 may exhibit a similar variable tensile force. In some forms, the material surface of the woven membrane 3130 that contacts the patient's face may advantageously have low friction characteristics (e.g., a low friction finish), which may lead to improved material conformance with the patient's face while improving patient comfort.

[0462] In some instances, the lower cushioning layer (e.g., a portion or second wall portion 3126) may help optimize the contact surface area of ​​the seal 3130 with the patient's face. Additionally, in instances where the seal 3130 is constructed from a breathable material (e.g., a breathable fabric), the lower cushioning layer may provide sufficient contact area at the rear of the seal so that the seal with the patient's face seals properly and avoids leaks.

[0463] The lower cushion layer may provide additional flexibility, making the cushion suitable for use with most patient faces (e.g., one size fits most). For example, the seal may be constructed as a double air-assisted seal (e.g., a double woven membrane), a seal including a compression support layer (e.g., open-cell foam, polyurethane foam, gel), a seal with a TPU, TPE, or silicone support layer, or a double air-assisted seal with an additional support layer (e.g., a double woven membrane with an inner membrane provided with a foam laminate layer (e.g., open-cell, polyurethane) or topped with a TPU, TPE, polyurethane, or silicone molded layer).

[0464] In use, engagement of the patient's face 1000 with the sealing portion 10130 generates a temporary deflection force that attempts to pull the walls of the support structure 10120 toward each other, as shown in FIGURE 43. The support structure 10120 responds to this deflection force with a counter force that pulls it outward. The counter force causes the more compliant sealing portion to preferentially stretch, transferring more tension to the sealing portion 10130 by applying the spring force generated within the sealing portion to the patient's face.

[0465] The sealing portion 10130 may be integral with the support structure by molding the sealing portion 10130 to the inner edge of the support structure 10120 or by otherwise attaching the sealing portion 10130 to the inner edge of the support structure 10120. Thus, for example, when the periphery of the sealing portion 10130 is attached to the inner edge of the support structure 10120, the sealing portion 10130 may extend radially inward of the seal-forming structure, extending beyond or wider than the support structure 10120. The inner edge of the support structure 10120 may be curved, such that the sealing portion 10130 is angled slightly inward toward the interior of the mask. Attaching the sealing portion 10130 along the inner edge of the support structure 10120 eliminates the need to crease or cut the sealing portion 10130 to fit around corners of the support structure 10120. This may advantageously reduce the occurrence of prominent folds or wrinkles in the sealing portion 10130 (which may cause leakage), which may improve sealing performance.

[0466] 5.3.4.1 Textile membrane According to an example of the technology of the present disclosure, the seal-forming structure 3100 may include a woven membrane 3130 comprising a woven material (see, e.g., 10133). The woven material may be coated or otherwise applied with an airtight membrane / film or layer to obtain an air-retaining woven composite. The woven composite may be cut (e.g., die-cut, ultrasonic, laser, or RF) to a desired shape and then attached to the support structure 3120. The resulting woven sealant 3130 (or woven membrane) may be attached to the support structure 3120 (e.g., silicone, TPE) by, for example, overmolding or injection molding. In another example, the woven sealant 3130 may be heat-welded at its edge (periphery) onto the material of the support structure 3120 (e.g., silicone, TPE). In another example, the woven sealant 3130 may not be connected to the support structure 3120, and the cushion interface 3105 may be substantially constructed of the woven material.

[0467] In some examples, ultrasonic cutting may be used to produce a woven membrane 3130 with minimal fraying. For example, using an ultrasonic cutting process, the edges of the cut material may melt, limiting fraying (e.g., compared to other cutting processes). This may increase the durability of the woven membrane 3130 and limit instances of leaks or other defects.

[0468] In certain configurations, a sheet of woven membrane 10...

Claims

1. 1. A patient interface for delivering a flow of air at a continuous positive pressure relative to ambient air pressure to an entrance to a patient's airways, including at least the entrances to the patient's nares, in a sealed manner, said patient interface being configured to deliver a flow of air at a pressure 4 cmH above ambient air pressure in use throughout the patient's respiratory cycle while the patient is asleep. ２ 0 to 30cmH ２ It is configured to maintain a high range of therapeutic pressure and improve sleep-disordered breathing. The patient interface includes: At least 6 cmH above ambient air pressure ２ a plenum chamber at least partially defining a cavity pressurizable to an elevated therapeutic pressure, said plenum chamber including a plenum chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for breathing by a patient; a seal-forming structure; Including, The seal-forming structure includes: a silicone support structure; a woven membrane attached to the support structure along its outer periphery such that the woven membrane extends radially inward beyond the support structure; and It has the textile membrane is constructed and arranged to form a seal against an area of ​​the patient's face surrounding the entrance to the patient's airway below a nasal bridge region of the patient's face; the textile membrane having two holes and a bridge region formed between the two holes such that the air flow at the treatment pressure is delivered to at least the entrance to the patient's nostrils; the seal-forming structure constructed and arranged to, in use, maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle; The woven membrane is a first layer constructed from a textile material and configured to contact the patient's face; a second layer coated directly onto the first layer, the second layer being constructed from an elastomeric material and forming a portion of the interior wall of the cavity; Including, In use, the woven membrane comprises: a predetermined lateral curvature in the up-down direction that is curved in a negative direction; a predetermined longitudinal curvature portion in the left-right direction that is curved in the positive direction; have Patient interface.

2. The patient interface of claim 1 , wherein the first layer is an air permeable layer.

3. 3. The patient interface of claim 1, wherein the first layer is exposed around at least a portion of a periphery of the at least one hole in the textile membrane.

4. 4. A patient interface according to claim 1, wherein the first layer is configured to receive a portion of the air flow that exits the plenum chamber through the two holes in the textile membrane.

5. A patient interface according to any preceding claim, wherein the textile membrane has a lateral curvature on each lateral side of the seal-forming structure.

6. A patient interface according to any preceding claim, wherein the elastomeric material of the second layer is air impermeable.

7. A patient interface according to any preceding claim, wherein the longitudinal curvature forms a saddle region.

8. A patient interface according to any preceding claim, wherein the lateral curvature forms a dome shape.

9. A patient interface according to any preceding claim, wherein the longitudinal curvature defines a positively curved shape configured to cradle the patient's nose in use.

10. the textile membrane includes an arch portion on each side of the two holes; A patient interface according to any preceding claim, wherein each of the arches is in a relaxed state prior to use and each of the arches is configured to be in a taut state during use.

11. The patient interface of any one of claims 1 to 10, wherein the patient interface is a nasal cushion, a nasal cradle, an oral-nasal cushion, a miniature full face mask, or a full face mask.

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