Woven fabric seal-forming structure with multiple curvatures

Abstract

The patient interface includes a seal-forming structure including a woven membrane having at least one aperture for delivering airflow at a therapeutic pressure to at least an inlet to the patient's nostril and / or an inlet to the patient's mouth. The seal-forming structure is constructed and arranged to maintain a therapeutic pressure within the cavity of the plenum chamber during the patient's entire respiratory cycle in use. The woven membrane includes a first region that is maintained in a relaxed state and a second region that is maintained in a taut state. The taut state of the second region is configured such that the seal-forming structure assumes a three-dimensional shape with multiple curvatures.

Description

[Technical Field]

[0001] 1 Cross-reference to related applications This application claims priority to Australian Provisional Application No. 2020902371, filed July 9, 2020, and 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.

[0002] International Patent Application No. PCT / IB2019 / 058832 claims the benefit of U.S. Provisional Application No. 62 / 805,147, filed March 13, 2019, and also claims the benefit of Australian Provisional Application No. AU2018904886, filed December 21, 2018, and Australian Provisional Application No. AU2018903752, filed October 16, 2018, each of which is incorporated by reference in its entirety. [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. This is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the tongue region, soft palate, and posterior oropharyngeal wall during sleep. This condition causes affected individuals to experience breathing pauses typically lasting 30 to 120 seconds, sometimes as many as 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 conditions:

[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, non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) are used to treat one or more of the above-mentioned respiratory disorders.

[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 atmosphere, throughout the patient's respiratory cycle.

[0014] Nasal continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action is that CPAP functions 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: it is 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 respiratory 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 the delivery of a continuous, heated, humidified airflow through an unsealed or open patient interface at a "therapeutic flow" that remains nearly constant throughout the respiratory cycle. The therapeutic flow is nominally set to exceed the patient's peak inspiratory flow. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that delivering a high flow of air to the airway inlet 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. 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 breathing 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 with sufficient dispersion (e.g., at a positive pressure of about 10 cmH2O relative to atmospheric pressure) with ambient pressure for therapy implementation. In other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of a gas supply to the airways at a positive pressure of about 10 cmH2O. For flow therapies, 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. If the mask is uncomfortable or difficult to use, patients may not comply with the therapy. Because patients are often encouraged to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean the mask, which may affect patient compliance.

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

[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 MIRAGELIBERTY® 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 air flow 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., the reliability, size, and weight requirements of medical equipment). In addition, even devices designed for medical treatment may suffer from deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[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).

[0048] [Table 1]

[0049] 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.

[0050] The ResMed Elisee® 150 ventilator and ResMed VSIII® ventilators can provide invasive and non-invasive dependent respiratory support suitable for adult or pediatric patients for the treatment of multiple conditions. These ventilators offer volumetric and pressure ventilation modes using single or dual limb circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) and are configured to deliver airflow to the patient's airway. In some cases, the airflow can be delivered to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface, as described above.

[0051] 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.

[0052] 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.

[0053] 2.2.3.4 Humidifier Delivery of airflow without humidification can lead to dryness of the airway. When a humidifier is used with an RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing 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 full-time wear. MRDs can be custom-made or manufactured in standard forms and include bite impression sections designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension on the pharyngeal walls, reducing airway collapse and palatal vibration.

[0061] In certain embodiments, the mandibular advancement device may include an upper splint intended to engage or mate with the maxilla or teeth on the maxilla, and a lower splint intended to engage or mate with the mandible or teeth on the mandible. The upper and lower splints are laterally connected to each other via a pair of connecting rods that are fixed symmetrically on the upper and lower splints.

[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)

[0068] [Table 2]

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

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

[0071] [Table 3]

[0072] 2.2.4 Screening, diagnostic and monitoring systems

[0073] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, but it typically requires specialized clinical staff for system application. PSG typically involves placing 15–20 contact sensors on the human body to record various body signals (e.g., electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), and electromyography (EMG)). PSG for sleep-disordered breathing requires patients to be observed for two nights in a specialized hospital: the first night for pure diagnosis and the second night for clinician-assisted titration of treatment parameters. Therefore, PSG is expensive and inconvenient. Screening, diagnosing, and monitoring sleep-disordered breathing is particularly unsuitable for home use.

[0074] In general, screening and diagnosis involve identifying disease through signs and symptoms. Screening typically produces a true / false result indicating whether a patient's SDB warrants further investigation, while diagnosis often produces clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the progression of disease can continue indefinitely. While some screening / diagnostic systems are adapted solely for screening / diagnosis, some can also be used for monitoring.

[0075] A clinical expert may adequately screen, diagnose, or monitor a patient based on visual observation of the PSG signal. However, there are situations where a clinical expert is unavailable or cannot be paid for. Different clinical experts may have different opinions about a patient's condition. Furthermore, some clinical experts may apply different criteria at different times. [Prior art documents] [Patent documents]

[0076] [Patent Document 1] U.S. Patent No. 4,944,310 Summary of the Invention [Means for solving the problem]

[0077] 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.

[0078] A first aspect of the present technology relates to devices used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disease.

[0079] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0080] An aspect of certain forms of the present technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.

[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 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; 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] According to 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, wherein bridge portions of the woven membrane are crimped such that they are held with a higher tension than the remainder of the woven membrane.

[0084] Another 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 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 (eg, selectively tensioned) than the remainder of the woven membrane.

[0085] In some embodiments, the woven membrane has at least one hole or two holes formed therein so that a flow of air at said therapeutic pressure is delivered to at least the entrance to the patient's airways.

[0086] In some embodiments, tensioning of the portions is achieved through various techniques (e.g., crimping at one or more regions of the woven membrane (e.g., the central portion and / or bridge regions)). Instead of or in addition to the central or bridge regions, one or more other regions of the woven membrane can be tensioned (e.g., crimping or other techniques). As an alternative or additional example to selective tensioning of one or more regions of the woven membrane, the woven membrane can be supported by a flexible support that can undergo selective tensioning.

[0087] Another 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 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 the nasal bridge region of the patient's face, the textile membrane having at least one hole 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, in use, maintain the therapeutic pressure within the cavity 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.

[0088] 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 one of the patient's nares 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 member and a second member, the first member being substantially flat and configured to contact the patient in use, and the second member extending 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 affixed to the second member.

[0089] 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.

[0090] In some embodiments, a) the woven membrane includes a first curvature about a first axis intersecting the first hole and the second hole, and before 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-shaped region and a saddle-shaped region, and the first curvature has the other of the dome-shaped region and the saddle-shaped 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 skewed 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.

[0091] 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.

[0092] 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 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.

[0093] 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.

[0094] Another 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 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 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 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.

[0095] Another form 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 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; 1. A seal-forming structure including a fabric 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 textile membrane having at least one hole such that a flow of air 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 a textile membrane constructed and arranged to, in use, maintain said therapeutic pressure within the cavity throughout the patient's respiratory cycle; 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 including a seal-forming structure configured such that the seal-forming structure includes a three-dimensional shape having multiple curvatures.

[0096] In some embodiments, a) the at least one hole portion includes a nostril opening configured to be positioned adjacent a patient's nostril and a mouth portion configured to be positioned adjacent a patient's mouth in use; b) the bridge portion extends across the nostril opening and divides the nostril opening into a first hole portion and a second hole portion, each of the first hole portion and the second hole portion configured to be positioned adjacent one of the patient's nares in use; c) the bridge portion is the second portion and is held in tension; and / or d) the bridge portion is crimped using ultrasonic welding and / or adhesive.

[0097] In some embodiments, a) the first region at least partially comprises the mouth region; b) the first region comprises members of the mouth region and the nose region; c) the seal-forming structure further comprises a flexible support structure for holding the woven 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 woven membrane of the seal-forming structure is curved about at least two non-parallel axes due to the tension in the second region to form the three-dimensional shape; g) the mouth region is curved about at least two non-parallel axes; and / or h) the woven membrane comprises a woven layer and a silicone layer coupled to the woven layer, the silicone layer being impermeable. In some embodiments, a) the seal-forming structure is constructed from a woven membrane, the woven membrane having a first sub-member and a second sub-member spaced apart from the first sub-member; b) the seal-forming structure further includes a flexible support region constructed from a material other than the woven membrane, the flexible support region being disposed between the first sub-member and the second sub-member; c) the second sub-member is disposed above the first sub-member in use; d) the second sub-member is disposed at least partially between ends of the first sub-member; and e) the at least one hole region 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. f) the at least one hole portion includes a nostril opening configured to be positioned adjacent a patient's nostril and a mouth region configured to be positioned adjacent a patient's mouth, the perimeter of the nostril opening being formed by the second sub-member; the perimeter of the mouth region is at least partially formed by a combination of the first sub-member and the second sub-member; g) the first sub-member forms at least a portion of the mouth region and includes an annular shape; and / or h) the second sub-member forms at least a portion of the mouth region and includes a U-shaped shape.

[0098] In some embodiments, a) a single continuous piece of fabric membrane is used to construct the mouth and nose regions; b) the patient's nose and upper lip are configured to contact only the fabric membrane in use; and / or c) a foam insert coupled to the seal-forming structure and configured to contact the patient's nasal ala in use.

[0099] In some embodiments, the woven membrane is configured to be curved about at least two non-parallel axes due to the bridge regions being crimped.

[0100] In some embodiments, the bridge region is crimped using ultrasonic welding and / or adhesive.

[0101] In some embodiments, the length of the bridge region is directly related to the size of the first hole and the size of the second hole.

[0102] In some embodiments, the bridge portion includes a first member and a second member, the first member being substantially flat and configured to contact the patient in use, and the second member extending into the plenum chamber.

[0103] In some embodiments, ultrasonic welding and / or adhesive is applied to the second component.

[0104] In some embodiments, the seal-forming structure comprises a single wall and an end of the flexible support structure contacts the textile membrane.

[0105] In some embodiments, the seal-forming structure includes a pair of walls, the flexible support structure includes a free end, and the woven membrane is coupled to the flexible support structure distal to the free end, the free end being spaced apart from the woven membrane such that the woven membrane is positioned radially outward from the free end.

[0106] In some embodiments, the flexible support structure is coupled to the woven membrane by injection molding.

[0107] In some embodiments, the bridge portion becomes a positioning spigot after being crimped.

[0108] In some embodiments, the textile membrane comprises a textile layer and a silicone layer coupled to the textile layer, wherein the silicone layer is impermeable.

[0109] In some embodiments, the thickness of the silicone layer is approximately 0.5 mm.

[0110] In some embodiments, the woven membrane comprises a multi-layer woven material and a silicone layer coupled to the multi-layer woven material.

[0111] In some embodiments, the multilayer textile material comprises a first layer, a second layer, and a third layer, wherein the silicone layer is in contact with only the first layer, and the third layer is configured to contact the patient's face during use.

[0112] In some embodiments, the first and third layers are constructed of nylon and the second layer is constructed of spandex.

[0113] In some embodiments, the silicone layer is disposed within the cavity and is configured not to contact the patient's skin during use.

[0114] In some embodiments, the silicone layer has low durometer properties and the textile membrane comprises high stretch capability when coupled to a flexible support structure.

[0115] In some embodiments, the thickness of the woven membrane is between approximately 0.35 mm and approximately 0.45 mm.

[0116] In some embodiments, the woven membrane includes a first curvature about a first axis that intersects the first opening and the second opening, and before being crimped, the bridge region includes a bridge curvature in an opposite direction from the remainder of the woven membrane about the first axis.

[0117] In some embodiments, 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.

[0118] In some embodiments, the secondary curvature has a concave shape opposite to the primary curvature.

[0119] In some embodiments, the secondary curvature is configured to contact the patient's subnasal point in use.

[0120] In some embodiments, a third axis extends transverse to the second axis and is distorted relative to the first axis, and the woven membrane comprises a third order curvature about the third axis.

[0121] In some embodiments, the cubic curvature is configured to contact the patient's upper lip in use.

[0122] In some embodiments, a fourth axis extends transverse to the second and third axes, and parallel to the first axis, the woven membrane comprises a fourth order curvature about the fourth axis.

[0123] In some embodiments, the fourth order curvature comprises a variable radius of curvature.

[0124] In some embodiments, the fourth order curvature extends into the first order curvature near the edge of the woven membrane.

[0125] In some embodiments, a portion of the first hole distal to the bridge portion is movable between a first position and a second position.

[0126] In some embodiments, the first position is a natural state and the woven membrane moves to the second position due to an external force.

[0127] In some embodiments, a portion of the first hole extends into the plenum chamber at the second location.

[0128] In some embodiments, the first hole comprises a generally teardrop shape at the second location.

[0129] In some embodiments, in the second position, the first hole portion is configured to contact the periphery of the entrance to one of the patient's nostrils adjacent the nostril rim.

[0130] In some embodiments, the portion of the second hole distal to the bridge portion is movable between a first position and a second position.

[0131] In some embodiments, the patient's nose and upper lip are configured to contact only the textile membrane during use.

[0132] In some embodiments, the patient interface is a nasal cushion, a nasal cradle, an oral-nasal cushion, a mini full face mask, or a full face mask.

[0133] In another aspect of the present 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 comprising: 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 a first hole and a second hole with a bridge region 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 the entrance to the patient's nares, the seal-forming structure being 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 predefined curved shape, the textile 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 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 extends around the nasolabial fold of the patient's nose, and the second axis configured 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 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.

[0134] In some embodiments, the bridge region is crimped to maintain the third curvature and limit reversal to the first curvature.

[0135] In some embodiments, the bridge region is crimped using ultrasonic welding and / or adhesive.

[0136] In some embodiments, the woven membrane is substantially impermeable to air.

[0137] In some embodiments, the textile membrane comprises a textile layer and a silicone layer coupled to the textile layer, wherein the silicone layer is impermeable.

[0138] In some embodiments, the thickness of the silicone layer is approximately 0.5 mm.

[0139] In some embodiments, the silicone layer is disposed within the cavity and is configured not to contact the patient's skin during use.

[0140] In some embodiments, the silicone layer has low durometer properties and the textile layer comprises high stretch capability when coupled to a support structure.

[0141] In some embodiments, the thickness of the woven membrane is between approximately 0.35 mm and approximately 0.45 mm.

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

[0143] In some embodiments, the seal formation includes a pair of walls, the flexible support structure includes a free end, and the woven membrane is coupled to the flexible support structure distal to the free end, the free end being spaced apart from the woven membrane such that the woven membrane is positioned radially outward of 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 have 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 textile membrane is configured to contact only the patient's upper lip, subnasal point, and nasal tip when in use.

[0149] In some embodiments, the flexible support is coupled to the textile membrane by injection molding.

[0150] In some embodiments, the woven 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.

[0151] In some embodiments, the region affected by the second curvature is formed by a generally rectangular region encompassing the first hole and the second hole, the generally rectangular region having a generally tangential relationship to the first hole and the second hole, the generally tangential relationship limiting wrinkling in the woven membrane.

[0152] 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 comprising: 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 a first hole and a second hole with a bridge region 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 the entrance to the patient's nares, the seal-forming structure being 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 predefined 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.

[0153] In some embodiments, the textile membrane includes a fourth curvature about a fourth 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.

[0154] In some embodiments, the bridge region is crimped to maintain the third curvature and limit reversal to the first curvature.

[0155] In some embodiments, the bridge region is crimped using ultrasonic welding and / or adhesive.

[0156] In some embodiments, the woven membrane is substantially impermeable to air.

[0157] In some embodiments, the textile membrane comprises a textile layer and a silicone layer coupled to the textile layer, wherein the silicone layer is impermeable.

[0158] In some embodiments, the thickness of the silicone layer is approximately 0.5 mm.

[0159] In some embodiments, the silicone layer is disposed within the cavity and is configured not to contact the patient's skin during use.

[0160] In some embodiments, the silicone layer has low durometer properties and the textile layer comprises high stretch capability when coupled to a support structure.

[0161] In some embodiments, the thickness of the woven membrane is between approximately 0.35 mm and approximately 0.45 mm.

[0162] In some embodiments, the seal-forming structure comprises a single wall and an end of the flexible support structure contacts the textile membrane.

[0163] In some embodiments, the seal formation includes a pair of walls, the flexible support structure includes a free end, and the woven membrane is coupled to the flexible support structure distal to the free end, the free end being spaced apart from the woven membrane such that the woven membrane is positioned radially outward of the free end.

[0164] 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.

[0165] 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 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 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.

[0166] Another 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 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; The fabric membrane includes a seal-forming structure that is held in tension.

[0167] One form of the present technology involves a woven seal-forming structure with a bridge region between a first hole and a second hole, the entire woven seal-forming structure being held in tension.

[0168] Another aspect of one form of the present technology is a seal-forming structure that includes a woven membrane connected in tension to a flexible support structure, where bridge portions of the woven membrane are substantially flattened due to the tension.

[0169] Another aspect of one form of the present technology is a seal-forming structure that includes a woven membrane connected to a flexible support structure in a taut state prior to use, the woven membrane having a substantially flat surface in at least one direction in the taut state prior to use.

[0170] In some embodiments, tensioning of the woven membrane is achieved through a variety of techniques (e.g., the absence of crimps in one or more regions of the woven membrane (e.g., the central portion and / or bridge regions)). The central portion and / or bridge regions may be taut and substantially flat prior to use by the patient. The woven membrane may be supported by a flexible support and may be stretched or otherwise tensioned prior to connection to the flexible support.

[0171] 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.

[0172] One aspect of the present technology is a method for manufacturing a device.

[0173] 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.

[0174] 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).

[0175] An aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.An aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, for example with soapy water, without the need for special cleaning equipment.

[0176] The described methods, systems, devices, and apparatus may be implemented to enable improved functionality in a processor (e.g., a processor in a special purpose computer, a respiratory monitor, and / or a respiratory treatment device). Further, the described methods, systems, devices, and apparatus enable advancements in the art of automated management, monitoring, and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0177] 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.

[0178] 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]

[0179] 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 [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] An outline of the human respiratory system including the nasal and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart and diaphragm. [Figure 2B]Diagram of the human upper respiratory tract including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, esophagus, and trachea. [Figure 2C] A front view of the face including several features of the surface anatomy including upper lip, vermilion, lower lip, mouth width, medial canthus, alae of the nose, nasolabial folds, and corners of the mouth. The superior, inferior, radially inward, and radially outward directions are also indicated. [Figure 2D] A lateral view of the head including several features of the surface anatomy, including the glabella, serrion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest, superior and inferior ear base points. The directions of superior and inferior, and anterior and posterior are also indicated. [Figure 2E]

[0023] Figure 1 is a further lateral view of the head, showing the approximate locations of the Frankfort horizontal and nasolabial angle. The coronal view is also shown. [Figure 2F] A bottom view of the nose including several features including the nasolabial fold, lower lip, upper lip vermilion, nostrils, subnasal point, columella, nasal tip, major axis of the nostrils and midsagittal plane. [Figure 2G] FIG. 1 is a side view of the surface features of the nose. [Figure 2H] Shown are the subcutaneous structures of the nose, including the lateral nasal cartilages, nasal septum cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibro-adipose tissue. [Figure 2I] The mid-nasal incision is shown approximately a few millimeters from the midsagittal plane, with particular attention paid to the nasal septum cartilage and the medial crus of the greater alar cartilage. [Figure 2J] FIG. 1 is a frontal bony view of the skull, including the frontal, nasal, and cheekbones, with the nasal turbinates shown along with the maxilla and mandible. [Figure 2K] This is a side view of the skull, showing the outline of the head surface and some muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius. [Figure 2L]Shows the anterolateral side of the nose. 4.3 Patient Interface [Figure 3A] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3B] 3C is a schematic cross-sectional view of the structure cut at a point, with the outward normal at this point shown, and the curvature at this point has a positive sign and a relatively large magnitude compared to the magnitude of the curvature shown in 3C. [Figure 3C] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a positive sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3D] Schematic cross-section of a structure cut at a point, where the outward normal at this point is shown and the curvature value at this point is zero. [Figure 3E] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point. The curvature at this point has a negative sign and a relatively small magnitude compared to the magnitude of the curvature shown in FIG. 3F. [Figure 3F] 3B is a schematic cross-sectional view of the structure cut at a point, showing the outward normal at this point, where the curvature at this point has a negative sign and a relatively large magnitude compared to the magnitude of the curvature shown in FIG. [Figure 3G] 1 shows a mask cushion including two pillows, the outer surface of the cushion is shown, the edge of the surface is shown, and the dome region and saddle region are shown. [Figure 3H] 1 shows a cushion for a mask. The outer surface of the cushion is shown. The edge of the surface is shown. The path on the surface between points A and B is shown. The linear distance between A and B is shown. Two saddle regions and a dome region are shown. [Figure 3I] The surface of a structure is shown, with a one-dimensional hole drilled into the surface. The planar curves shown form the boundary of the one-dimensional hole. [Figure 3J]3B is a cross-sectional view through the structure of Figure 3I. The surfaces shown bound a two-dimensional hole in the structure of Figure 3I. [Figure 3K] 3I includes a two-dimensional hole and a one-dimensional hole, and the surfaces bounding the two-dimensional hole in the structure of FIG. 3I are also shown. [Figure 3L] 1 shows a mask with an inflatable bladder as a cushion. [Figure 3M] 3L is a cross-sectional view of the mask of FIG. 3L showing the inner surface of the bladder, which bounds the two-dimensional hole in the mask. [Figure 3N] 3D shows a further cross section through the mask of FIG. 3L, with the interior surface also shown. [Figure 3O] Demonstrates the left-hand rule. [Figure 3P] Demonstrates the right-hand rule. [Figure 3Q] 1 shows the left ear including the left ear helix. [Figure 3R] The right ear is shown, including the right ear helix. [Figure 3S] Shows a right-handed spiral. [Figure 3T] 1 is a diagram of a mask including the signature of the twist of the space curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] A view of the plenum chamber 3200 showing the midsagittal plane and the central contact plane. [Figure 3V] A posterior view of the plenum chamber of Figure 3U. Directions in the figure are perpendicular to the central contact plane. In Figure 3V, the midsagittal plane bisects the plenum chamber into a left-hand side and a right-hand side. [Figure 3W] 3V is a cross-sectional view through the plenum chamber of FIG. 3V, where the cross-section is taken in the midsagittal plane shown in FIG. 3V. The "central contact" plane is shown. The central contact plane is perpendicular to the midsagittal plane. The orientation of the central contact plane corresponds to the orientation of the tendon 3210. The tendon 3210 rests on the midsagittal plane and contacts the cushion of the plenum chamber only at two points on the midsagittal plane (i.e., superior point 3220 and inferior point 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 midsagittal plane of the plenum chamber 3200 generally coincides with the midsagittal plane of the face when the plenum chamber is in the use position. The central contact plane generally corresponds to the "face plane" when the plenum chamber is in the use position. In Figure 3X, the plenum chamber 3200 is that of a nasal mask, with the upper point 3220 resting approximately on the selion and the lower point 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

[0180] [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 it is being worn by a patient; [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-like 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] 33-3 is a rear perspective view of the cushion assembly of Fig. 33-3, which has a thicker corner nose region to provide a smaller space to receive 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 tension 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] Shows the knitting process. [Figure 46] 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 folded about a first axis. [Figure 50] FIG. 49 is a perspective view of the woven material of FIG. 49 folded about a first axis and a second axis, where the second axis is not parallel to the first axis, and where the fold about the second axis causes wrinkles and / or creases to occur in the woven material. [Figure 51] 1 is a perspective view of a woven material for use as a seal-forming structure, the woven material being folded and processed about three non-parallel axes 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] 54 is a perspective view of the woven material of FIG. 53 folded about non-parallel axes. 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 57] Detail of the woven material showing the perimeter of the opening, which can vary depending on the length of the crimped bridge section. [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 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 61] 61 is a side perspective view of the cushion assembly of FIG. 60 with the arcuate portions folded inward so that the opening comprises a generally teardrop shape. DETAILED DESCRIPTION OF THE INVENTION

[0181] 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.

[0182] 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.

[0183] 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.

[0184] 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.

[0185] In certain embodiments of the present technology, mouth breathing is restricted, limited or prevented.

[0186] 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.

[0187] 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 airways so as to maintain positive pressure at the entrance(s) to the patient's 1000 airways. Thus, the sealed patient interface 3000 is suitable for delivery of positive pressure therapy.

[0188] 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.

[0189] 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.

[0190] 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.

[0191] 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. 5.3.1 Seal formation structure

[0192] 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).

[0193] In one form, the target seal-forming area is located on an exterior surface of the seal-forming structure 3100 .

[0194] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material (eg, silicone rubber).

[0195] A seal-forming structure 3100 according to the present technology may be constructed from a soft, flexible and resilient material (eg, silicone).

[0196] In some embodiments, such as those shown in Figures 6-39, the seal-forming structures 3100, 6100, and 9100 have sealing portions that include a woven material. The woven material may cover all or part of the seal-forming structures 3100, 6100, and 9100. In some embodiments, the woven material may include 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 to form a woven membrane or woven sealing portion.

[0197] 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.

[0198] 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.

[0199] 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.

[0200] In some forms, the woven membrane may include at least one layer that exhibits substantially air-impermeable properties (while maintaining the material properties necessary to provide comfort and minimal pressure points to the patient). For example, as shown in FIG. 40 , in some forms, the woven membrane may include an air-impermeable material 10131 (e.g., a silicone layer) formed on one side of the woven material 10133. The air-impermeable material 10131 may be laminated onto the woven material 10133 in some forms. In some forms, the air-impermeable material 10131 and the woven material 10133 may be selected so that the resulting woven membrane 10135 can exhibit a predetermined overall elasticity or elastic resistance, as desired. For example, the addition of the air-impermeable material 10131 (or membrane layer) may impart elasticity (or extensibility) to the woven material 10133, thereby increasing the extensibility of the resulting woven membrane 10135. The air impermeable material 10131 may also have low durometer properties so as not to interfere with the elasticity of the woven material 10133. In other words, the elasticity (or extensibility) of the woven material 10133 is not substantially reduced with the addition of the air impermeable material 10131, since the woven membrane 10135 has substantially the same elasticity as the woven material 10133 alone.

[0201] The air impermeable material 10131 may have a thickness that is less than the thickness of the woven material 10133. Thus, the relatively small thickness of the air impermeable material 10131 may not significantly increase the weight of the woven material 10133, which may assist in maintaining 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.

[0202] In some examples, the thickness of the woven membrane 10135 is between approximately 0.25 mm and approximately 0.55 mm. In some examples, the thickness of the woven membrane 10135 is between approximately 0.30 mm and approximately 0.50 mm. In some examples, the thickness of the woven membrane 10135 is between approximately 0.35 mm and approximately 0.45 mm. In some examples, the thickness of the woven membrane 10135 is approximately 0.40 mm.

[0203] In some examples, the thickness of the air impermeable membrane 10131 is approximately 0.01 mm to approximately 0.10 mm. In some examples, the thickness of the air impermeable membrane 10131 is approximately 0.02 mm to approximately 0.08 mm. In some examples, the thickness of the air impermeable membrane 10131 is approximately 0.03 mm to approximately 0.07 mm. In some examples, the thickness of the air impermeable membrane 10131 is approximately 0.04 mm to approximately 0.06 mm. In some examples, the thickness of the air impermeable membrane 10131 is approximately 0.05 mm.

[0204] In some embodiments, the woven material 10133 may be formed as a multi-layered fabric. In other words, multiple woven pieces may be combined together to form the overall woven material 10133. As shown in FIG. 40-1 , the woven material 10133 may be constructed from three 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 spirit of these embodiments. Additionally, the first layer 10133a and the third layer 10133c may be formed from different materials (ie, not the same materials).

[0205] In some embodiments, the overall composition of woven material 10133 can be at least 50% nylon and up to 50% spandex. In some embodiments, the overall composition of woven material 10133 can be approximately 60% to approximately 90% nylon and approximately 10% to approximately 40% spandex. In some embodiments, the overall composition of woven material 10133 can be approximately 70% to approximately 85% nylon and approximately 15% to approximately 30% spandex. In some embodiments, the overall composition of woven material 10133 can be approximately 82% nylon and approximately 18% spandex (e.g., JCD4018 from WeiMei Fabrics Limited).

[0206] 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 upon application of force and returning to its original shape when the force is removed. Thus, the woven material 10133 may be able to function like a sponge by at least partially absorbing 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 gaps 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 without wrinkling or creating potential air leak sites. 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, the seal-forming structure 3100 being easier to don). It may also allow the seal-forming structures 3100, 6100, and 9100 to move and / or shift (without wrinkling) as they are being worn, because the sponge-like properties assist in maintaining the necessary contact with the patient's skin.

[0207] 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.

[0208] 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 less than approximately 20 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). The fine knit of the textile may also prevent permeation of the air impermeable layer 10131 through the textile layers 10133 (e.g., during the manufacturing process). For example, the fine knit of the first layer 10133a may limit all permeation or allow some permeation, while substantially limiting permeation into the other layers 10133b and 10133c. In other words, the first layer 10133a functions 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 can be tolerated because the relative stiffness of the first layer 10133a is less critical to patient comfort than the third layer 10133c (which directly contacts the patient's skin). Thus, the elasticity of the spandex may be lost due to contact with the air-impermeable layer 10131. Furthermore, the smooth texture of the third layer 10133c may 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 can be constructed that does not substantially restrict patient comfort.

[0209] 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.

[0210] In some embodiments, the thickness T of the air impermeable layer 10131 I1 In some embodiments, the thickness T of the air impermeable layer 10131 is approximately no more than 500 microns. I1 In some embodiments, the thickness T of the air impermeable layer 10131 is between approximately 4 microns and approximately 400 microns. I1 In some embodiments, the thickness T of the air impermeable layer 10131 is between approximately 8 microns and approximately 300 microns. I1 In some embodiments, the thickness T of the air impermeable layer 10131 is between approximately 12 microns and approximately 200 microns. I1 In some embodiments, the thickness T of the air impermeable layer 10131 is between approximately 16 microns and approximately 100 microns. I1 In some embodiments, the thickness T of the air impermeable layer 10131 is between approximately 20 microns and approximately 70 microns. I1 is approximately 40 microns.

[0211] In some embodiments, the actual thickness T of the air impermeable layer 10131 in the woven membrane 10135 I2is the thickness T of the air impermeable layer 10131 before being coated onto the fabric material 10133. I1 In other words, if the air impermeable material 10131 penetrates into the first layer 10133a, the thickness T I1 partially overlaps with the thickness of the first layer 10133a, so that the thickness T I2 is the total thickness T of the air impermeable layer 10131 I1 is less than.

[0212] Thickness T of the air impermeable layer 10131 I2 Even if the density is lower (e.g., due to leaching), the density remains substantially the same. In some embodiments, the density of the airtight layer 10131 does not exceed approximately 500 grams per square meter (GSM). In some embodiments, the density of the airtight layer 10131 is between approximately 5 GSM and approximately 400 GSM. In some embodiments, the density of the airtight layer 10131 is between approximately 50 GSM and approximately 300 GSM. In some embodiments, the density of the airtight layer 10131 is between approximately 100 GSM and approximately 200 GSM. In some embodiments, the density of the airtight layer 10131 is between approximately 110 GSM and approximately 130 GSM. In some embodiments, the density of the airtight layer 10131 is approximately 120 GSM.

[0213] 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., approximately 20 to approximately 40) 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.

[0214] 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.

[0215] In some configurations, the woven membrane 10135 may exhibit a low spring constant (i.e., high compliance) in both warp and weft directions. In such configurations, in contrast to conventional designs that may result in distortion of the patient's face 1300 due to a fixed cushion (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 that makes the woven membrane 10135 more compliant than the patient's skin that engages it. 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 structure 3100, 6100, 9100.

[0216] 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.

[0217] 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.

[0218] 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).

[0219] 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.

[0220] 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 peripheral length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is or includes a spring-like element that functions to support the sealing flange against buckling during use.

[0221] 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., flexible support structure 3120).

[0222] 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, creases, 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 the members of the seal-forming structure 3100 that may be sources of therapeutic air leakage.

[0223] 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. 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 give the woven membrane 3130 a complex shape (e.g., multiple curvatures) (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 be more comfortable in some configurations, as the untensioned fabric places less pressure on the patient's face.

[0224] 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.

[0225] 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.

[0226] 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.

[0227] 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 as a passageway through which therapeutic application occurs in a more stretched material. In some examples, the area (e.g., the periphery) of the woven membrane 3130 that is directly connected to the support structure 3120 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.

[0228] 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.

[0229] 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.

[0230] 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).

[0231] 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 load of the internal air pressure causes the textile membrane 3130 to elastically stretch to create 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 reaction force from the internal air pressure (i.e., the "hovercraft effect").

[0232] 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 textile 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 textile 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 textile membrane surface 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 textile membrane were in contact with the patient's nose), providing the grip pad 3150, 9150 on the textile 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, having only a small area covered with silicone (or other gripping material) (rather than a relatively large area of textile (or entirely silicone)) may provide greater comfort to the patient than if the entire seal-forming structure 3100, 9100 were formed from silicone (or other similar material).

[0233] 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.

[0234] 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 T-woven membrane 3130 may be held at a 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 nasal alar nadir regions of the patient's face (i.e., the corners of the nose region (i.e., the region where the alar terminates at the upper lip adjacent the nasolabial fold))), as shown, for example, in FIG. 12 . The dome shape may help prevent wrinkles, fine lines, folds, and buckling in the woven membrane 3130, thereby helping prevent leak paths. The dome shape may also help the woven membrane 3130 reach into areas of the patient's face that are difficult to seal (e.g., 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 FIG. 12. Similarly, the nasal tip point region 3270 may 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.

[0235] 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 woven membrane 6130, 9130 attached to the outer edge of the support structure 6120, 9120, such that the woven membrane 6130, 9130 forms part of the seal-forming structure 6100, 9100 and extends from the front to the rear, face-contacting side of the seal-forming structure along curved portion 35 as described above with respect to Figure 12, so that, for example, the woven membrane 6130 of the cushion assembly 6105 may have a more dome-shaped portion (due to a negative curvature from one lateral side to the other). In other words, because the woven membrane 6130 is attached to the support structure 6120 with curvatures in different directions and / or about different axes, the woven membrane 6130 may be formed with both an inward curve and a dome-shaped portion. 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).

[0236] In some forms, the central portion of the woven membrane 3130 has a saddle 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).

[0237] 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 less structurally rigid than the support structure 3120 (e.g., a silicone membrane).

[0238] 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).

[0239] In some forms, 3D printing the fabric membrane and / or cushion support member as a "skeleton" can reduce thickness and, consequently, mask weight.

[0240] In some configurations, different layers of the mask layer can be printed with different stiffness, hardness, or thickness. For example, the "skeleton" member can be formed using Si, PU foam, PU solid material, or any suitable plastic material.

[0241] 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.

[0242] 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 which are held taut in use, for example, by adjacent regions of the sealing flange.

[0243] In one form, the seal-forming structure includes an area having a sticky or adhesive surface.

[0244] 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.

[0245] 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.

[0246] 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.

[0247] 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.

[0248] 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.

[0249] 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.

[0250] 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.

[0251] 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.

[0252] 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.

[0253] 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.

[0254] 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.

[0255] 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 from the environment) (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. Furthermore, 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-tip 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, for example, FIG. 12).

[0256] An example of a nasal cradle cushion 3105 (e.g., the exemplary seal-forming structure 3100 disclosed herein) may include an upper saddle 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 the upper central surface 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.

[0257] 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).

[0258] 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 peripheral edge of the plenum chamber 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 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.).

[0259] 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 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) accumulating 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 may be 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 (e.g., to allow for observation), the rigid material may be constructed from a transparent and / or translucent material (e.g., clear polycarbonate).

[0260] 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 nasal 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 nasal openings 3102 are not large enough to accommodate the patient's nose (e.g., the tip of the nose) within the cavity 3101.

[0261] 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.

[0262] On each side of the plenum chamber 3200, a plenum chamber lateral end 3202 may be provided as a hollow passageway forming a plenum chamber inlet port sized and configured to receive airflow. A plenum chamber connector 3204 may also be provided at each lateral end of the plenum chamber 3200, outwardly of the plenum chamber lateral end 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 removable 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 both be permanent.

[0263] The lateral ends 3202 of the plenum chamber 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, and then through the seal-forming structure 3100, and into the patient's airway for inspiration.

[0264] 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.

[0265] 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).

[0266] 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 lowest alar region of the patient's face.

[0267] 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.

[0268] The sealing portion 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 sealing portion 3130 described in any of the examples of this disclosure may be referred to as a woven sealing portion 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).

[0269] 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 any other suitable manner, as described below.

[0270] 12-15, the wall structure of the seal-forming structure 3100 may include lateral support regions 3122. The lateral support regions 3122 are thicker than other portions of the wall structure of the support structure 3120. Each seal-forming structure 3100 may include lateral support regions 3122 at its lateral-most side. The seal-forming structure 3100 may include two lateral support regions 3122, each spaced apart distally from a plane that bisects the seal-forming structure 3100, which plane is parallel to the sagittal plane of the patient in use. The lateral support regions 3122 may be the thickest portions of the seal-forming structure 3100, thereby providing resistance to lateral displacement (e.g., when a patient rests their head on a side and presses a pillow 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.

[0271] The woven membrane 3130 may be formed such that it forms a portion of the seal-forming structure 3100 that extends in a curved manner from the anterior side 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 the alar nadir 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 geometry of the alar nadir region of the patient's face is particularly complex because at least three facial surfaces (alas, upper lip, and cheeks) 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.

[0272] As mentioned above, Figures 19-21 show grip pads 3150 on the surface 3130 of the textile membrane.

[0273] 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.

[0274] 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.

[0275] In one form, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the attractive force on the patient interface 3000.

[0276] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0277] 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.

[0278] 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.

[0279] 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.

[0280] 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.

[0281] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient-contacting layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes loop material that engages with portions of hook material.

[0282] 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 seals the seal-forming structure 3100 against a portion of the patient's face. In one example, the strap can be configured as a tie.

[0283] 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.

[0284] 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.

[0285] 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.

[0286] 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.

[0287] 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.

[0288] 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.

[0289] 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 the flow of pressurized gas from the hub 3306 to the end 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).

[0290] 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.

[0291] 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 patient heads of different shapes and sizes.

[0292] 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.

[0293] 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.

[0294] 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 underneath the patient's nose (e.g., at or below the nasal tip and at least above the vermilion of the upper lip).

[0295] Additionally, each lateral portion 3302 may include a tab 3308 that receives a rear strap end 3311 of the rear strap 3310. The rear strap 3310 may be length adjustable, 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 length adjustable 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).

[0296] 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 end 3302.

[0297] In some forms (see FIG. 7 ), 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, which 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.

[0298] 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.

[0299] 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.

[0300] 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.

[0301] 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.

[0302] 8, and particularly as shown in FIG. 9, the inner layer 6352 includes a fabric sheet 6360 with a membrane 6362. The fabric sheet 6360 may be formed from a felt, a foam material, a woven, knitted, or nonwoven material, or other fiber network.

[0303] 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.

[0304] 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).

[0305] In certain forms, the vent 3400 is configured to allow continuous vent flow from the interior of the plenum chamber 3200 to atmosphere when the pressure within the plenum chamber is positive relative to atmosphere. The vent 3400 is configured such that the magnitude of the vent flow is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining therapeutic pressure within the plenum chamber in use.

[0306] 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).

[0307] 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.

[0308] 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 is provided with 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 flushing at high humidification levels because the cross section of the hole does not decrease across 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.

[0309] 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.

[0310] 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 because 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 because 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 blockage of the holes during lying down while still allowing the middle member of the chassis to remain sufficiently rigid.

[0311] 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 washout, even at extreme humidification. In the example shown, the vents in the vent 3400 do not provide the entire airflow for the system. 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 function to wash out carbon dioxide exhaled by the patient during treatment.

[0312] 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).

[0313] 5.3.2.5 Decoupling Structures (Singular or Plural) In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0314] 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.

[0315] The decoupling structure 3500 may also include a swivel 3502 that allows for a rotatable connection to the air circuit 4170 .

[0316] 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.

[0317] 5.3.2.6 Connection Port The connection port 3600 allows connection to the air circuit 4170 .

[0318] 5.3.2.7 Forehead support In one form, the patient interface 3000 includes a forehead support 3700 .

[0319] 5.3.2.8 Anti-asphyxiation valves In one form, the patient interface 3000 includes an anti-asphyxiation valve.

[0320] 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.

[0321] 5.3.3 Full face mask 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.

[0322] 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.

[0323] The cushion assembly 9105 includes a nose region 9101, nose region openings 9103, a mouth region 9102, a mouth region 9104, a cavity 9001, a support structure 9120, a sealing region 9130, and a vent region 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 separately discussed. A pair of plenum chamber openings are configured to receive airflow.

[0324] The cushion assembly 9105 (e.g., in particular the nose 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 front to the rear 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 nose region 9101) may include at least one curved surface. This may be obtained by a crimp in the nose region 9101, as will be described in more detail below. When the cushion assembly 9105 is in use, the curved surface of the cushion assembly 9105 resulting from the crimp may extend along the lateral direction of the patient's face (e.g., in the left-right direction). For example, the curved surface of the cushion assembly 9105 resulting from the crimp may extend curvedly about an axis perpendicular to the 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.

[0325] 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.

[0326] 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 have a curved surface like the nasal region 9101.

[0327] 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.

[0328] 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.

[0329] 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 discussed below.

[0330] 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 peripheral edges of the plenum chamber 6200 are 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.

[0331] 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.).

[0332] 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.

[0333] The plenum chamber 6200 according to embodiments of the present technology may include a plenum chamber hole on each side. 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.

[0334] 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 may be joined by a mechanical interlock. In the mechanical connection, no chemical bond is formed between the plenum chamber 6200 and the seal-forming structure 6100.

[0335] 5.3.3.2 Seal formation structure 26-33, the seal-forming structure 6100 may include a nose portion 6101 having at least one hole (e.g., a pair of nose portion openings 6103) for sealing against and transferring pressurized air to the patient's nares. In the illustrated embodiment, two separate openings 6103 are provided, each corresponding to one of the patient's nostrils, to provide airflow to both of the patient's nares. A bridge portion 6106 may be provided between the nostril openings 6103. In another example, a single opening may be used to provide pressurized flow to both of the patient's nares. In a further alternative, three or more openings 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.

[0336] 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 under more tension than surrounding first sealing portion 9131.

[0337] 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.

[0338] 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.

[0339] 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 the patient's face. The sealing portion 6130 is sufficiently large (e.g., curved anteriorly a sufficient amount) so that only the sealing portion 6130 (e.g., only the woven membrane) contacts and sealingly engages the patient's face. Alternatively, the support structure 6120 may be constructed of a woven material.

[0340] 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 lowest alar region of the patient's face.

[0341] 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 sealing portion 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).

[0342] In the example of FIG. 32, the support structure 6120 can extend into the cavity 6001 to form a lower cushion 6121 that provides support to the sealing portion 14130. The lower cushion 6121 and the sealing portion 6130 can form a double-wall structure around the sealing portion. In another example, a second or third lower cushion layer can 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 another example, the lower cushion 6122 can be constructed of silicone, as shown in FIG. 33. However, it will be appreciated that the lower cushion can be constructed of other suitable materials (e.g., fabric).

[0343] The sealing portion 6130 may be constructed from two different pieces of fabric 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 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.

[0344] 26-33, the first sealing portion 6131 is located at an upper portion (i.e., in use) of the patient interface 6000 compared 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.

[0345] 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.

[0346] 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-shaped shape and a seal around a portion of the patient's mouth. The woven membrane forming the second sealing portion 6132 does not extend all the way around the patient's mouth. In other words, materials other than the woven membrane may come into contact with the patient when forming a seal around the patient's mouth. In this example, to complete the mouth area 6104, a support structure 6120 (e.g., a silicone material) is molded between the free ends of the second sealing portion 6132. The woven 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.

[0347] 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.

[0348] As shown in FIG. 33-1 , the second sealing portion 21130b extends around the patient's entire 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 sub-member and the second sub-member). While the support structure 21120 may have some contact with the patient's upper lip, sealing is achieved primarily or exclusively through the fabric membranes within the first sealing portion 21130a and the second sealing portion 21130b. In other words, the area where the support structure 21120 contacts the patient's skin may not be under pressure and / or may be exposed to the atmosphere during treatment. Extending the second support structure 21130b around the patient's mouth may increase patient comfort compared to a U-shaped second sealing structure 21130b (e.g., because the patient may find the fabric membrane more comfortable than silicone), which may result in increased patient compliance with treatment.

[0349] In another example of the patient interface 23000, as shown in FIG. 33-2, the second sealing portion 23130b is U-shaped. However, the philtrum and center of the upper lip contact the fabric membrane. In this example, the first sealing portion 23130a extends downward to the edge of the mouth area 23104. In other words, the first sealing portion 23130a 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 23130b extends substantially around the remainder of the patient's mouth (although a small portion of the support structure 23120 is disposed laterally left to right between the first sealing portion 23130a and the second sealing portion 23130b). 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 23130a and the second sealing portion 23130b has been removed in the superior / inferior direction. A small portion of the support structure 23120 between the first sealing portion 23130a and the second sealing portion 23130b may assist in creating a pressurized volume around the patient's mouth.

[0350] In other examples of the patient interface 25000, as shown in FIG. 33-3 , the sealing portion 25130 is formed from a single piece of woven material. In other words, the first sealing portion 25130a and the second sealing portion 25130b are not constructed from separate pieces of material. The single piece of material forming the sealing portion 25130 functions to form a seal around both the patient's nose and the patient's mouth. The sealing portion 25130 may have a perimeter similar to that described above (e.g., in the example patient interface 25000 having first and second sealing portions 25130). In some examples, the sealing portion 25130 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 sealing portion 25130 may also seal against the patient's upper lip to more directly deliver pressurized air to the patient's airway. By using a single piece of textile membrane to form the sealing portion 25130, 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 two textile membrane pieces to connect them. This simplifies the molding process and eliminates the need to pour a small amount of material, such as silicone, between them, which also does not cover the textile layer 10133.

[0351] 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.

[0352] 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).

[0353] 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.

[0354] 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.

[0355] In one form, the positioning and stabilizing structure 9300 provides a holding force sufficient to overcome the attractive force on the patient interface 9000.

[0356] 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 accidental interference with the patient interface).

[0357] 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.

[0358] 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.

[0359] 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.

[0360] 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.

[0361] 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 material 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.

[0362] 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 seals the seal-forming structure against a portion of the patient's face. In one example, the strap can be configured as a tie.

[0363] 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 the superior-ear-base point of the patient's head.

[0364] 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.

[0365] 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.

[0366] 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.

[0367] 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.

[0368] 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.

[0369] 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.

[0370] 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.

[0371] 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.

[0372] 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).

[0373] 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).

[0374] The conduit connector 6800, described in more detail below, may also include a venting feature.

[0375] 5.3.3.5 Decoupling Structures (Singular or Plural) In one form, the patient interface 9000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0376] 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.

[0377] The connection port 9600 and connection port housing 9903 may be positioned above the patient's head in use.

[0378] 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.

[0379] 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 portion 3302 and upper portion 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 lateral 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.

[0380] 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.

[0381] The conduit 9900 may include features of similar conduits disclosed in International Application Publication No. WO 2017 / 124155 A1, which is incorporated 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 herein.

[0382] 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.

[0383] The conduit 9900 may also include a tie connector 9902 to facilitate connection with a tie of the positioning and stabilizing structure 9300.

[0384] 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 a flow of pressurized air 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.

[0385] 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).

[0386] 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 side of the cushion assembly 6105, with each conduit connector 6800 connected to a plenum chamber aperture on a corresponding 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.

[0387] The conduit connector 6800 may be attached to the 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 providing the conduit connector 6800 to the side of the plenum chamber as shown in the illustrated embodiment, greater visibility of the patient's face is achieved, and this arrangement may improve the 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.

[0388] 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 connection between the conduit and the conduit connector 6800 at the conduit connection end 6802 that is sufficiently reliable 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).

[0389] 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.

[0390] 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.

[0391] 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.

[0392] 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.

[0393] 5.3.4 Support structure and sealing arrangement The support structures and sealing portions of the above examples can have a number of different configurations and arrangements.

[0394] In use, sealing contact between the sealing portion 3130 (e.g., the woven 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 woven membrane 3130, which is untensioned and formed as a substantially constant surface without leaks that could cause obstructions in the woven membrane 3130 (e.g., wrinkles, folds, buckling, or fine lines); and / or 3) air pressure within the cavity against the interior surface of the sealing portion 3130. Each of these factors may contribute to the sealing portion 3130 conforming to the anthropometric contours of the patient's face, thereby minimizing wrinkles or ruptures and maximizing the contact area of the sealing portion 3130. Tension in the sealing portion 3130 may increase due to any of these factors, but if the associated factor is removed, the sealing portion 3130 may return to a relaxed state.

[0395] 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. The support structure 3120 may also impart curvature to the sealing portion 3130. In the illustrated example, the sealing portion 3130 may include curvature about multiple axes. This may assist in contouring by the sealing portion 3130 to the complex facial anatomy of different patients.

[0396] 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.

[0397] 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 help eliminate a central opening in the woven membrane 3130, thereby 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 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 result in improved 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).

[0398] The woven membrane 6130 (e.g., the first sealing portion 6131) may be held relatively taut prior to contact with the patient (e.g., the first sealing portion 6131 may be under continuous tension). 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 face). 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 application of further tension 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).

[0399] Compared to conventional silicone membrane press-compressed foam seals, the sealing portion 3130 in some of the present examples has a more flexible structural stiffness, which provides dynamic springback properties, allowing the sealing portion 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 sealing portion 3130 more comfortable and reducing facial scarring during use.

[0400] 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 central portion 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 sealing portion that contacts the patient's face (e.g., 3130) may have low friction characteristics (e.g., a low friction finish), which may advantageously lead to improved material conformance with the patient's face while improving patient comfort.

[0401] The woven membrane 3130 may exhibit variable tension across the material (e.g., higher tension near the bridge region 3104). The woven membranes 9130, 21130, 23130, 21530 may exhibit similar variable tension. 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.

[0402] In some examples, the lower cushioning layer(s) (e.g., a portion or second wall portion 3126) may help optimize the contact surface area of the sealing portion 3130 with the patient's face. Additionally, in examples where the sealing portion 3130 is constructed from a breathable material (e.g., a breathable fabric), the lower cushioning layer(s) may provide sufficient contact area behind the sealing portion to properly seal with the patient's face and avoid leakage.

[0403] The lower cushion layer(s) can provide additional flexibility, making the cushion suitable for use with most patient faces (e.g., one size fits most). For example, the sealing section can be constructed as a dual air-assisted sealing section (e.g., a dual woven membrane), a sealing section with a compression support layer(s) (e.g., open-cell foam, polyurethane foam, gel), a sealing section with a TPU, TPE, or silicone support layer(s), or a dual air-assisted sealing section with additional support layer(s) (e.g., a dual woven membrane with an inner membrane provided with a foam laminate layer (e.g., open-cell, polyurethane) or a TPU, TPE, polyurethane, or silicone molded layer).

[0404] 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 FIG. 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.

[0405] 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 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 such that it extends 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. By attaching the sealing portion 10130 along the inner edge of the support structure 10120, there is no need to crease or cut the sealing portion 10130 to fit around the corners of the support structure 10120. This may advantageously reduce the occurrence of prominent creases or wrinkles in the sealing portion 10130 (which may cause leakage), which may improve sealing performance.

[0406] 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, for example, 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) into a desired shape and then attached to the support structure 3120. The resulting woven sealing portion 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 sealing portion 3130 may be heat-welded at its edge (periphery) onto the material (e.g., silicone, TPE) of the support structure 3120. In another example, the woven sealing portion 3130 may not be connected to the support structure 3120, and the cushion interface 3105 may be substantially constructed of the woven material.

[0407] In one example, the textile material 10133 is a woven extensible fabric. Examples include knitted materials, woven materials, or any other suitable material. Knitted materials may be preferred because they can provide elasticity (e.g., extensibility) in textiles (especially compared to woven materials). This can be advantageous because it provides comfort for the patient, as described below. Elasticity can be provided in all directions (e.g., four-way stretch / elasticity (e.g., substantially equal elasticity in all directions)), at least in the transverse left-right direction of the textile membrane. The textile material may have, for example, a weft-knitted or warp-knitted structure. The textile material 10133 may also have any other suitable knitted structure. A weft-knitted structure is more desirable because the elasticity of a weft-knitted fabric is higher than that of a warp-knitted fabric.

[0408] Figure 45 shows the weft knit fabric fabric 70, or the direction in which loops of one yarn are joined to loops of another yarn. The path 80, or direction, of loops from a single yarn is shown in Figure 46. In the basic closed-loop warp knit 90 shown in Figure 47, the fabric and path run parallel to each other. In the weft knit 100 shown in Figure 48, the fabric 70 runs perpendicular to the path 80.

[0409] 5.3.4.1.1 Manufacturing The various contours contained within the human face can be described as positive or negative curvature and as dome or saddle regions. To enhance patient comfort, the seal-forming structure 3100 ideally or substantially matches these contours. However, as noted above, the seal-forming structure 3100 needs to be smooth and continuous on the patient's face without any folded sections that could serve as a pathway for air leakage. Therefore, the seal-forming structure 3100 must be formed with complex geometries and multiple curvatures to complement the patient's face without creating surfaces that are prone to leaks.

[0410] As shown in FIG. 49, a woven material (e.g., a woven membrane 3130) may be folded about a single axis 11000 (e.g., a horizontal axis as shown in FIG. 49). In this state, the woven material 3130 has a negative dome curvature (e.g., is substantially convex) as shown in FIG. 49. The woven material 3130 is substantially smooth in this orientation (e.g., the curvature has a constant radius R). In other words, the woven material 3130 is substantially free of wrinkles and / or wrinkles when oriented with folds about the single axis 11000. This is true regardless of the folding axis or the folding direction when the woven material 3130 is folded. In other words, the woven material 3130 may be creased about a vertical axis (i.e., not a horizontal axis) and / or may have a positive dome curvature (i.e., not a negative curvature), and the surface of the woven material 3130 remains substantially free of wrinkles and / or wrinkles. Furthermore, varying the amount of curvature does not result in wrinkles and / or wrinkles in the woven material. In other words, a single fold in the woven material may include a large or small radius of curvature without the occurrence of wrinkles and / or wrinkles in the woven material. Thus, different positive and negative curvatures (e.g., as shown in Figures 3B-3C and 3E-3F) can be applied to the woven material without the occurrence of wrinkles and / or wrinkles.

[0411] To accommodate complex patient surface orientations (and variations between individual patients), a seal-forming structure 3100 including multiple folds for increased contact with the patient's face is more desirable. Because curvatures on a patient's face exist around various axes oriented in multiple directions, ideally these curves would be around different, non-parallel axes. However, as shown in FIG. 50 , adding additional (e.g., second, third, or fourth) folds to the woven material can result in fine lines and / or wrinkles. Wrinkles and / or wrinkles can occur when two or more folds occur along non-parallel axes 11000, 11500. In other words, multiple folds along parallel axes may not all result in fine lines and / or wrinkles, but they also may not produce an optimal three-dimensional shape for sealing with the patient's face (e.g., because they do not match the contours of the patient's face). By adding curvatures along non-parallel axes, the surface may not be able to remain smooth and continuous. Thus, any seal-forming structure 3100 generated from a fabric containing more than two folds is unlikely to form an effective seal against the patient's face.

[0412] One way to effectively create curvature in a material along multiple, non-parallel axes is to apply tension to at least a portion of the woven material 3130. The tension can help maintain the shape of the various curvatures while limiting and / or avoiding the formation of wrinkles and / or wrinkles.

[0413] One method of tensioning is to stretch the extensible woven material 3130, imparting multiple curvatures (e.g., along multiple non-parallel axes) onto the woven material under tension. The woven material 3130 can then be subjected to a process (e.g., heat forming) to permanently hold the woven material 3130 in the strained state (i.e., with the multiple curvatures). As shown in FIG. 51 , the woven material 3130 includes multiple curvatures while its surface remains relatively smooth. This woven material 3130 can therefore be employed as a seal-forming structure 3100 in the patient interface 3000 to provide a seal against the patient's face without causing substantially any leakage of pressurized air from the plenum chamber 3200 to the atmosphere. In this example, substantially the entire woven material 3130 is under tension.

[0414] However, after the woven material 3130 is stretched and heat-formed (or subjected to a similar process), the woven material 3130 substantially loses its free-state properties. For example, any elasticity that the woven material 3130 may naturally have is substantially lost after heat-forming is complete. Once stretched, the woven material 3130 becomes relatively stiff while including multiple curvatures. The free-state (i.e., pre-heat-forming) properties (e.g., drape, flexibility, elasticity) of the woven material 3130 are also important in determining the sealing ability of the final woven seal-forming structure 3100. Therefore, if the woven material 3130 is no longer in its free state, the quality of the seal generated by the woven material 3130 may also be reduced in some patients. In other words, a curved woven material 3130 formed using heat forming may conform more comfortably to the patient's face (e.g., compared to a woven membrane 3130 formed with only a single bend), and if the free-state characteristics of the curved woven material 3130 were lost, the ability of the patient interface 3000 to effectively seal with some patients' faces may be hindered. Although free of wrinkles and / or creases, a seal-forming structure 3100 formed in this manner may still experience leakage (e.g., because the woven membrane 3130 is too stiff to conform to some patients' faces). For other patients, a sufficient seal may be obtained to prevent leakage.

[0415] This is not the case with the woven material 6130 of Figures 26-33, as the material includes free-state characteristics. Because the first sealing portion 6131 is intended to be substantially flat prior to use, there is no need to heat-form the material to retain its shape. The material can still stretch and conform to the patient's face. Thus, the woven material 6130 may limit leakage, in contrast to the examples above. The patient interface 6000 may also be easier to manufacture, as the woven material 6130 may not include complex curvatures.

[0416] 52-61 illustrate another method of tensioning only a portion of the woven membrane 3130. For example, less than half of the woven membrane 3130 may be under tension while the remainder of the woven membrane 3130 is in a slack or relaxed state. Thus, tension is selectively applied to distinct locations of the woven membrane 3130. Tension may be applied to different locations of the woven membrane 3130 (e.g., the center, the sides) to help impart different shapes of curvature. Additionally, more than one location within a single woven membrane 3130 may be under tension. Selective tensioning of the woven membrane 3130 may be accomplished using any number of techniques, some of which are described below.

[0417] One exemplary technique for selectively tensioning only a portion of the woven membrane 3130 can be achieved by crimping a portion of the woven membrane 3130. Crimping can provide localized tension without placing the entire woven membrane 3130 under tension. Crimps can be applied to any portion or portions of the woven membrane 3130. In some instances, most of the woven membrane 3130 is not crimped. In other words, the crimped areas of the woven membrane 3130 are smaller than the uncrimped areas of the woven membrane 3130. In some instances, a portion of the woven material 3130 can be removed on at least one side of the crimped area. In some instances, no holes or other discontinuities are required to form the crimped areas.

[0418] In some examples, a crimp may be applied to the center of the woven membrane 3130. The crimping may be achieved by removing a portion of the woven material 3130 (e.g., to form holes 3102) while the woven material is in a free state (i.e., not yet heat-formed). The woven material 3130 can then be manipulated around the created holes 3102 to limit the formation of wrinkles and / or wrinkle formation. These holes 3102 may later be used as nostril openings (for delivery pathways of pressurized air to the patient's nostrils).

[0419] As shown in Figure 52, the woven material 3130 used in the nasal-only patient interface 3000 is illustrated. Two holes 3102 are cut (e.g., by hand, laser, etc.) in the woven material, each hole 3102 corresponding to a single nostril of the patient. However, any number of holes 3102 may be cut (e.g., a single opening for both nostrils, an additional opening for the oral cavity) depending on the end use of the woven material. These holes 3102 are cut into the woven material 3130 before or after the first fold is made. The order of forming and cutting the single (i.e., first) fold does not substantially affect the presence of wrinkles and / or fine lines.

[0420] With particular reference to the woven material used in nasal masks such as that shown in FIG. 52 , the holes 3102 are each elongated and formed as a generally rectangular shape, although other shapes (e.g., circular, triangular) may be used in other examples. The holes 3102 may be separated by strips of material that may be formed as bridge regions 3104. The bridge regions 3104 may be formed independently of the holes 3102. If more than two holes 3102 are cut in the woven material 3130, multiple bridge regions 3104 may be obtained. Creating more bridge regions 3104 may be useful when additional holes are needed and / or when the woven material 3130 is larger (e.g., to prevent the woven material 3130 from buckling even with a single bridge region 3104). As described above, the patient's nose (eg, the tip of the nose) may contact the bridge portion 3104, which may limit the patient's nose from extending into the plenum chamber 3200.

[0421] As shown in FIG. 53 , after the initial fold is made about a first axis 11000 (e.g., a horizontal axis as shown in FIG. 53 ) and the holes 3102 are cut out, the bridge region 3104 can be folded (e.g., a second fold) about a second axis 12000 that is parallel to (or collinear with) the first axis 11000. In the illustrated example, flipping the bridge region 3104 downward (as shown in FIG. 53 ) creates a space between the pair of holes 3102. In other words, a positive dome curvature is imparted to the bridge region 3104 (e.g., as shown in FIG. 53 ), while the first fold results in a negative dome curvature.

[0422] In some forms, after the bridge region 3104 is folded, a space 3180 is created between the holes 3102. Specifically, the holes 3102 may be oriented vertically (e.g., as shown in FIG. 53 ), with the space 3180 oriented along the first axis 11000. In other words, each of the holes 3102 is substantially perpendicular to the first axis 11000, with the space 3180 existing between the openings of the holes 3102. The width of the space 3180 substantially corresponds to the width between the patient's alar or alar bridges. In other words, the width of the space 3180 is large enough to accommodate the patient's nose and to generally align the patient's nostrils with the spaces. When the nose is positioned within the space, the apex of the woven material 3130 (i.e., created by the first fold) contacts the patient near the nasolabial fold.

[0423] As shown in FIG. 54 , after the bridge regions 3104 are folded about the second axis 12000, the material is crimped to maintain the “inverted” orientation. Crimping can be one method for selectively tensioning portions of the woven membrane 3130 (without tensioning the entire woven membrane 3130). Other selective tensioning techniques can be used in conjunction with or instead of crimping. The bridge regions 3104 are maintained such that they lack the first curvature 10000 about the first axis 11000. For example, the bridge regions 3104 may not explicitly have a positive dome curvature (e.g., the magnitude of the curvature of the bridge regions 3104 may be smaller in FIG. 54 than in FIG. 53 , the curvature of the bridge regions 3104 may be zero, etc.). However, the bridge regions 3104 do not have a negative dome curvature (e.g., when the cushion assembly 3105 is in use) along with the remainder of the woven material 3130. In other words, after crimping occurs, the curvature of the bridge regions 3104 is different (e.g., in magnitude and / or direction) compared to the remainder of the woven material 3130.

[0424] In some examples, the bridge regions 3104 are crimped such that only the material forming the bridge regions is under tension (i.e., the crimping does not impart tension to the remainder of the woven membrane 3130). Specifically, the length of the bridge regions 3104 is re-folded to reduce the overall exposed length. The tension in the fabric comprising the crimped bridge regions 3104 is higher than the tension in the surrounding uncrimped fabric. Thus, the surface of the bridge regions 3104 may be substantially flat and / or have minimal curvature (e.g., curvature around the first axis 11000 is maintained through the remainder of the woven material 3130). The fold in the bridge regions 3104 may be substantially central, such that the lengths of material on either side of the fold line are substantially equal, although one side may be longer than the other. Although the crimp creates tension, the bridge regions 3104 may be able to flex (e.g., due to the woven fabric free state properties) relative to the holes 3102. The crimped bridge regions 3104 may resemble the uncrimped bridge regions 6106 (because both are under tension) but retain their free state material properties.

[0425] In other examples, other tensioning methods may be used to create the taut bridge regions 3104 and / or tension may be applied elsewhere on the textile membrane 3130.

[0426] In some examples, the length of the bridge region 3104 after crimping affects the size of the holes 3102. For example, if the available length remains large (i.e., the crimped length is small), the holes 3102 remain large. In other words, there is a direct relationship between the length of the crimped bridge region 3104 and the size of the holes 3102. If the length of the bridge region 3104 is shortened (i.e., shortened due to an increase in the crimped length), the size (e.g., circumference) of each hole 3102 will decrease due to tension in the crimped bridge region. The length of the bridge region 3104 can be adjusted based on the size of the patient's nose (e.g., the bridge region 3104 can be crimped to have small, medium, and large sizes to accommodate different sized nostrils).

[0427] In some examples, the bridge regions 3104 are held in the crimped state by ultrasonic welding and / or adhesive application (e.g., glue), although any suitable method may be used. Any of these methods may be applied to the unusable length 3184 of the bridge region 3104. For example, adhesive may be applied to selected portions of the fabric layer of the fabric membrane 3130, folding these selected portions toward each other. In other words, the usable length of the bridge region 3104 is substantially free of all of the added material. The crimped region of the bridge region 3104 may have the positive dome curvature described above, even after one of the above fixation methods has been applied.

[0428] In one example, a portion of the unusable portion 3184 of the bridge portion 3104 may be trimmed or cut out after application of the above-described fastening method. After fully assembling the textile membrane 3130 into the seal-forming structure 3100, the unusable portion 3184 may be located within the plenum chamber 3200 and obstruct airflow (e.g., generate noise). Thus, when the unusable portion 3184 is trimmed, all obstruction may be reduced or eliminated.

[0429] As shown in FIGS. 55-57, after crimping is complete, additional curvatures about different axes may be applied to the woven material 3130. Crimping the bridge region 3104 may reduce the total area 3188 affected by the additional curvature. In other words, the affected area 3188 (i.e., the shaded portion) and the crimped bridge region 3104 in FIG. 55 are smaller than the affected area 3190 in FIG. 51 where no crimping has occurred. The affected areas 3188, 3190 relate to regions where wrinkles and / or fine wrinkles are likely to occur (due to the multiple curvatures in the woven material 3130). When the bridge region 3104 is crimped, the affected area 3188 is substantially adjacent to the hole 3102. For example, the affected area 3188 may form a substantially rectangular shape, with edges that are substantially tangent to the hole 3102. Thus, by locating the affected area 3188 adjacent to the holes 3102, the occurrence of wrinkles and / or creases when additional curvature is used in the woven material 3130 is substantially avoided.

[0430] In some examples, the third curvature 30000 is formed in the woven material 3130 about a third axis 13000. The third axis may extend in a direction substantially perpendicular to (but may be oblique to) the first axis 11000 and the second axis 12000. In other words, the third axis 13000 may be a substantially horizontal axis (e.g., as shown in FIGS. 55-57). In the illustrated example, the third axis 13000 is centered on the woven material 3130 and extends along the bridge region 3104. The third curvature 30000 may have a substantially saddle-shaped region (e.g., as shown in FIGS. 55-57). In other words, the third curvature 30000 may be positively curved and may cradle the patient's nose after the patient dons the patient interface 3000. That is, the fabric layer 10133 is a saddle-shaped region, particularly about the third axis 13000, when the patient interface 3000 is worn. Thus, the second curvature 20000 and the third curvature 30000 may be curved in the same direction (e.g., both positive curvatures), but may extend about substantially perpendicular axes and define different regions (e.g., the second curvature 20000 is a dome and the third curvature 30000 is a saddle). While the third curvature 30000 is applied, the first curvature 10000 and the second curvature 20000 remain in their previously curved positions. In other words, when the third curvature 30000 (or further curvatures) is applied, there is substantially no effect on the magnitude and / or direction of the previous curvatures.

[0431] In some examples, the fourth curvature 40000 may be formed in the woven material 3130 about a fourth axis 14000. The fourth axis 14000 may extend along a direction substantially perpendicular to the first axis 11000, the second axis 12000, and the third axis 13000 (although the fourth axis 14000 may have any relationship to the other axes). In other words, the fourth axis 14000 may be a substantially perpendicular axis (e.g., as shown in FIG. 55). In the illustrated example, the fourth axis 14000 does not intersect with the bridge region 3104. The fourth curvature 40000 may extend toward the center of the woven material 3130 and may be a saddle-shaped region as shown in FIG. 55. In other words, the fourth curvature 40000 may cradle the patient's face (e.g., the patient's upper lip) after the patient dons the patient interface 3000.

[0432] In some examples, a fifth curvature 50000 can be formed in the woven material 3130 about a fifth axis 15000. The fifth axis 15000 extends along a direction substantially parallel to and offset from the first axis 11000 and the second axis 12000 (although the fifth axis 15000 can have any orientation). In other words, the fifth axis 15000 is a substantially horizontal axis (e.g., as shown in FIG. 56). In the illustrated example, the fifth axis 15000 does not intersect the bridge region 3104. The fifth curvature 50000 can have a similar orientation as the first curvature 10000 and can be a negative dome curvature (e.g., as shown in FIG. 56). The first curvature 10,000 and the fifth curvature 50,000 may have different magnitudes of curvature (e.g., the magnitude of the first curvature 10,000 may be in a more negative direction than the fifth curvature 50,000). The fifth curvature 50,000 may have a variable curvature because the radius of curvature may not be constant along the length of the axis 15,000. For example, because the fifth curvature 50,000 and the first curvature 10,000 are along substantially parallel axes, varying the radius of curvature of the fifth curvature 50,000 may combine (e.g., blend) the two curvatures 10,000 and 50,000 into one curvature. The fifth curvature 50,000 may have a smaller radius of curvature near the center (e.g., near the intersection with the third axis 13,000) and a larger radius of curvature near the edges of the woven material 3130. Here, the larger radius of curvature of the fifth curvature 50000 may blend with the first curvature 10000 (e.g., near the edges of the woven material 3130). In other words, as the radius of curvature of the fifth curvature 50000 increases, the fifth curvature 50000 may extend into the first curvature 10000. The blending of curvatures may help provide a smooth surface and limit the likelihood of wrinkles and / or wrinkles forming in the bent woven material 3130.

[0433] In some examples, both the fourth curvature 40,000 and the fifth curvature 50,000 are included on the woven material 3130. In other words, the mid-subnasal point region 3260 of the final seal-forming structure 3100 constructed from the woven material 3130 may include both the fourth curvature 40,000 and the fifth curvature 50,000. These curvatures 40,000 and 50,000 may cooperate to seal against compound curvatures (e.g., multiple curvatures in multiple directions) on the patient's upper lip. In the illustrated example, when both the fourth curvature 40,000 and the fifth curvature 50,000 are provided on the woven material 3130, the fourth curvature 40,000 is the dominant curvature of the mid-subnasal point region 3260. For example, the human head has a natural curvature as it approaches either lateral side. In other words, the upper lip curves to the left and right sides of the patient's face, extending from the philtrum to the corners of the mouth. The upper lip may also include curvature about a substantially horizontal axis extending perpendicular to the sagittal plane. However, this curvature spans a smaller distance (i.e., the distance between the subnasal point and the upper vermilion lip is less than the width of the mouth) and may vary more significantly among different patients (e.g., some patients may have a larger, more defined curve than others).

[0434] The fourth curvature 40000 is a larger curvature compared to the fifth curvature 50000. For example, there may be a woven material 3130 extending about the fourth axis 14000, with the lower edge of the woven material 3130 folded about the fifth axis 15000, so that the total area of the fourth curvature 40000 is greater on the woven material 3130. However, the crimped bridge portions 3104 allow both the curvatures 40000 and 50000 to be maintained within the overlap region (without the formation of wrinkles and / or creases). Thus, in some examples, the fifth curvature 50000 may extend along a curved path as it follows the length of the fourth curvature 40000, rather than entirely along the fifth axis 15000.

[0435] Some patients may have a substantially vertical upper lip between the subnasal point and the upper vermilion lip, resulting in substantially no curvature along a substantially horizontal axis perpendicular to the sagittal plane. For these patients, the fifth curvature 50,000 does not include the curved lip region to be sealed. However, the material of the fifth curvature 50,000 may deform into a substantially vertical (e.g., flat) region and still maintain an effective seal against the patient's face. Furthermore, the height between the subnasal point and the upper vermilion lip may vary from patient to patient. For example, this distance may be quite small. In this example, the woven material of the fifth curvature 50,000 may be deformed into a tight region and serve as a lead-in for forming an effective seal at any height. In another example, the woven material may be customizable for each individual patient, with the curvature and radius of curvature selected based on the specific patient's facial geometry (e.g., as may be determined using scanning).

[0436] Any number of these curvatures may be applied to a single seal-forming structure 3100 to help improve the fit of the patient interface 3000 to the patient's face. For example, all five of these curvatures may be applied to a single seal-forming structure 3100. In other examples, only a few of these curvatures may be applied to the seal-forming structure 3100. In other examples, more than five curvatures may be applied to the seal-forming structure 3100. The magnitude and / or direction of these curvatures may vary across individual cushion assemblies 3105 (e.g., the textile membrane 3130 may be custom made for individual patients).

[0437] In some examples, the shape of the textile membrane 3130 may be formed, and the textile membrane 3130 may be connected to the lateral support regions 3122. In the example shown, the textile membrane 3130 and the lateral support regions 3122 are connected by injection molding so that they are integrally formed with one another. In other examples, the textile membrane 3130 and the lateral support regions 3122 may be joined to one another in a different manner (e.g., overmolding). In yet other examples, the textile membrane 3130 may not be connected to the lateral support regions 3122.

[0438] In some examples, the three-dimensional shape of the woven membrane 3130 (i.e., resulting from multiple curvatures) may assist an injection molding tool in forming the flexible support structure 3120 and / or the plenum chamber 3200. For example, a bridge portion 3104 that is bent (e.g., crimped) about the second axis 12000 may be useful in loading the woven membrane 3130 into an injection molding tool. In particular, the crimped bridge portion 3104 may be used as a spigot in placing the woven membrane 3130 into the injection molding tool. In other examples, the woven material 3130 may be curved to completely form the plenum chamber 3200, thereby eliminating the need for injection molding material in the patient interface 3000. In other words, the plenum chamber 3200 and the seal-forming structure 3100 may be constructed from the woven material 3130 (rather than from silicone or other flexible molding material).

[0439] As shown in FIGS. 58 and 59 , a material (e.g., silicone) can be molded onto the textile membrane 3130. The material can be applied to the inner layer 3194 of the textile membrane 3130 (e.g., a layer coated with an air-impermeable material 10131) to avoid covering any portion of the textile on the posterior surface (and potential contact with the patient's face during use). However, in other examples, the material can be applied to the outer layer 3196 of the textile membrane 3130. The material can extend beyond the ends of the textile membrane 3130 into the plenum chamber 3200 (e.g., the material can be molded such that portions of the lateral support regions 3122 do not contact the textile membrane 3130). When the material is molded onto the textile membrane 3130, the resulting support structure 3120 can have substantially the same curvature (i.e., magnitude and direction) as the adjacent textile membrane 3130 (e.g., to create a substantially smooth and continuous surface). The thickness of the material (i.e., the lateral support regions) may vary along its length. For example, the lateral support regions 3122 may be thicker distal to the woven membrane 3130. Furthermore, the overall thickness of the overlapping woven membrane and material may be thinner than adjacent regions containing only the molding material (i.e., the lateral support regions 3122).

[0440] As shown in FIG. 58 , some examples of the patient interface 3000 may include a single wall lateral support region connected to the textile membrane 3130. To form the support structure 3120 that connects the seal-forming structure 3100 to the plenum chamber 3200, a single wall of silicone material may be molded to the textile membrane 3130. The outer surface 3195 of the support structure 3120 substantially matches the outer surface 3196 (i.e., textile layer) of the textile membrane 3130 to form a smooth, continuous surface. The inner surface 3197 may have a thickness different from those listed above. The silicone material overlaps a portion of the textile membrane 3130 to form a sturdy connection, but without adding unnecessary weight to the patient interface 3000. The silicone material may be tapered to be thinnest at the end of the overlap region 3199 (e.g., near the end 3124). The ends of the overlap region 3199 are spaced from the nostril openings 3102 to avoid potential interference with pressurized air into the patient's nares (e.g., causing noise). The overlap region 4000 substantially lies on the first curvature 10000 and may provide additional support to maintain proper size relative to the first curvature 10000.

[0441] As shown in FIG. 59 , some examples of patient interfaces may include a dual-walled support structure 3120 coupled to a woven membrane 3130. A single wall of silicone material may be molded into the woven membrane 3130 to connect the seal-forming structure 3100 to the plenum chamber 3200. As described above, the outer surface 3195 substantially matches the outer surface 3196 of the woven membrane 3130, and the inner surface 3197 includes a different thickness along the length. However, the overlap region 3199 may extend a different length along the inner surface 3194 of the woven membrane 3130. In particular, the overlap region 3199 may contact the length of the woven membrane 3130 (which shortens in the single-wall support structure 3120 as described above). Alternatively, a portion of the silicone wall 3126 may be continuous along the length of the woven membrane 3130 but spaced from the inner surface 3194. This second wall 3126 of the support structure 3120 may cantilever from the remainder of the lateral support region (i.e., from the end 3124). The support structure 3120, including the second wall 3126, may extend along a similar overall overlapping length as the support structure 3120 in the single-wall example. The second wall 3126 may be positioned near the apex of the first curvature 10000, particularly to provide additional support. The second wall 3126 may be stiffer than the woven membrane 3130 and may help the woven membrane 3130 maintain the shape of the first curvature 10000 upon contact with the patient's face. When additional force is applied, the woven membrane 3130 and the second wall 3126 may deform together.

[0442] After assembling the textile membrane 3130 to the support structure 3120, the resulting cushion assembly 3105 may be used in the patient interface 3000. In particular, the patient's face (e.g., the patient's nose) may be positioned within the space 3180 such that the nostril openings 3102 are positioned adjacent to each nostril.

[0443] When placing the cushion assembly 3105, the patient may align the bridge region 3104 with their nose. Specifically, the bridge region 3104 may be oriented in a front-to-back direction when the cushion assembly 3105 is being worn (e.g., the woven membrane 3130 may face substantially upward). As the patient moves the bridge region 3104 into contact with their nose, the taut material of the bridge region 3104 presses against the patient's nose (e.g., it may press against the patient's nose in the subnasal area and contact the bridge of the nose). The bridge region 3104 restricts movement of the patient's nose into the cavity 3101, but because the patient's nose is pressed against the taut material, tension may be applied to surrounding areas on the woven membrane 3130. In another example, the patient may move their face to another area of the woven membrane 3130 that is under tension (e.g., when the entire area of the woven membrane is under tension as in FIGS. 26-33).

[0444] While the patient is in contact with the bridge portion 3104, the patient may also come into contact with the lateral sides 3250 and / or corner regions 3252 of the textile membrane. The lateral side 3250 pressing corner regions are disposed on the region of the third curvature 30000 near the apex of the first curvature 10000. In other words, the lateral sides 3250 and corner regions 3252 are disposed on a surface having a saddle-shaped region and are opposed toward the center of the cushion assembly 3105. A positive curvature may be provided between the opposed lateral sides 3250. The lateral sides 3250 and corner regions 3252 may also be understood to be disposed near where the textile membrane transitions to a negative dome curvature (i.e., formed by the first curvature 10000) and are provided at the rear of the cushion assembly 3105. This transition region may be understood as the dome-shaped region of the sealing portion 3130. The lateral sides 3250 and / or corner regions 3252 may contact the outer surface of the sealing portion 3130 (e.g., near the patient's ala) and terminate near the apex of the ala on either side of the patient's nose. In this orientation, the nostril openings 3102 are aligned with the patient's nares, allowing for effective delivery of pressurized air to the patient's airways. The lateral sides 3250 and / or corner regions 3252 are generally loose, allowing these regions of the textile membrane 3130 to better conform to various contours of the patient's face. For example, the lateral sides 3250 and / or corner regions 3252 may be adjustable in shape to better conform to the areas around the patient's nares to form a tight seal. When the patient's nose engages the bridge portion 3104, tension (to maintain proper shape from the patient) may be exerted on the lateral sides 3250 and / or corner regions 3252.

[0445] As shown in FIG. 60 , the textile membrane 3130 can include arch portions 60000 adjacent each nostril opening 3102. These arch portions 60000 are also positioned near the lateral sides 3250 and / or corner regions 3252. The arch portions 60000 have saddle-shaped regions in the same direction as the first curvature 10000 (and also about the first axis 11000). The arch portions 60000 extend into the space 3180 such that the distance between the arch portions 60000 can be the shortest distance between opposing lateral sides 3250 and / or corner regions 3252.

[0446] When the patient wears the cushion assembly 3105, the nostril openings 3102 may have a generally vertical alignment (as described above), with the inner surface of each nostril contacting a respective arch portion 60000. In other words, each arch portion 60000 is configured to contact the inner surface of a respective ala of the nose. Because the patient's nose also contacts the bridge portion 3104 of the textile membrane 3130, each nostril opening 3102 completely surrounds a respective nostril.

[0447] As shown in FIG. 61 , after each arch portion 60000 contacts the inner surface of each nostril, the arch portion 60000 flips in a concave direction (i.e., a positive dome curvature relative to the inner surface of each nostril). This is similar to what occurs in the bridge region 3104, although the curvature of the arch portion 60000 may be oriented in a different direction. For example, each arch portion 60000 may move along the first axis 11000 toward each plenum chamber connector 3204. In this orientation, each nostril opening may have a generally teardrop shape.

[0448] When the arch portions 60000 are inverted (i.e., from a negative dome curvature to a positive dome curvature), the arch portions 60000 can wrap around the nostril edges of each nostril. In other words, each arch portion 60000 wraps around the periphery of each nostril. The compliant nature of the textile membrane 3130 allows the arch portions 60000 to adjust to the shape of the patient's nostril edges to form a seal sufficient to maintain treatment pressure within the plenum chamber 3200.

[0449] After the cushion assembly 3105 is properly positioned, the patient may apply pressurized air. The compliant nature of the textile membrane 3130, with its initially loose exterior (as opposed to being taut, e.g., at the bridge portion), allows the seal-forming structure 3100 to form a dynamic seal (as the cavity 3101 fills with pressurized air). This dynamic seal allows the cushion assembly to shift slightly over the patient's nose, delivering pressurized air to the patient's airway, while maintaining a pressurized cavity 3101. For example, the arch portion 60000 may be able to move slightly relative to the nares without losing its seal.

[0450] Additionally, the third curvature 30000, the fourth curvature 40000, and / or the fifth curvature 50000 may further assist in maintaining the position of the seal-forming structure 3100 and improving patient comfort. For example, the third curvature 30000 may have a saddle-like region with respect to the patient and may contact the patient's subnasal point region along the bridge of the nose (e.g., via a positive curvature). The third curvature 30000 may not extend to the patient's nasal tip, leaving the nasal tip exposed. The third curvature 30000 may be positioned within the nasal tip region 3270 of the textile membrane 3130. The fourth curvature 40000 may have a saddle-like region with respect to the patient and may contact the patient's upper lip (e.g., via a positive curvature). Thus, the fourth curvature 40000 may extend laterally (left / right) while worn by the patient, but may also extend substantially along the width of the mouth. The fifth curvature 50000 may have a negative dome curvature relative to the patient's upper lip. In other words, the fifth curvature 50000 curves away from the patient's upper lip and does not support the patient's upper lip cradle. The fourth curvature 40000 and the fifth curvature 50000 may contact substantially the same area of the patient's face, and one or both may be provided on a given textile membrane 3130. The fourth curvature 40000 and / or the fifth curvature 50000 may be positioned in the mid-subnasal point region 3260 of the textile membrane 3130. The fifth curvature 50000 may provide a "pillow" and / or "airbag" effect to the patient. In other words, when the negative dome curvature of the fifth curvature is used relative to the patient's upper lip during use, additional cushioning and / or comfort may be provided to the patient due to the pressurized air inflating the textile membrane 3130.

[0451] Although the above description relates specifically to the nasal cradle, the above description is equally applicable to the above-described patient interfaces 9000, 21000, 23000 and 25000. Further description specific to the full face cushion is provided below.

[0452] 5.3.4.1.1.1 Full face mask cushion In addition to the steps described above, the manufacture and assembly of a full face cushion differs from a nasal cushion because the full face cushion requires additional area to seal in the vicinity (i.e., around both the patient's nostrils and mouth). Thus, the overall size of the full face cushion is larger than the nasal cushion, requiring additional surface area in the fabric membrane 10135 and additional surface area (e.g., silicone material) in the support structure 6120.

[0453] 22-39 are assembled by placing two pieces of woven fabric 10135 into a mold and molding a flexible material (e.g., silicone) onto the woven fabric 10135 to form patient interfaces 6000, 9000, 21000, 23000, and 25000. In these examples, the two woven fabric membranes 10135 are different shapes to seal specific areas on the patient's face (although a single woven fabric membrane 10135 could also be used). As noted above, the first woven fabric membrane 10135 (i.e., the one used to form the first sealing portion 6131) has a curved shape, and the second woven fabric membrane 10135 may include a U- or C-shape (see, e.g., FIG. 33) or a ring- or annular shape (see, e.g., FIG. 33-1). The woven membranes 10135 are substantially flat (e.g., have a two-dimensional shape) before being placed in the mold. After the woven membranes 10135 are placed in the mold, the two woven membranes 10135 are spaced apart (e.g., by a gap 21190) slightly from one another. In some examples, the mold maintains the woven membrane 10135 in a partially flat position when a flexible material (e.g., silicone) is introduced into the mold (e.g., patient interface 6000). In some examples, the mold introduces curvature into the woven membrane 10135, holding the woven membrane 10135 in a curved shape when a flexible material (e.g., silicone) is introduced into the mold (e.g., patient interfaces 9000, 21000, 23000, and 25000). When the mold introduces curvature into the woven membrane 10135, the bridge regions (e.g., 9106) may fold over themselves. Once the flexible material is introduced into the mold and hardens, the two flexible woven membranes 10135 are secured together. After the molding process is complete, the bridge regions 9106 may be crimped to remove any slack in the woven membrane 10135. Alternatively, the bridge regions 9106 may be crimped before the woven membrane 10135 is placed in the mold. This may result in pre-deformation of the woven membrane 10135 (e.g., the woven membrane 10135 is deformed before being placed in the mold, imparting additional curvature to the remainder of the woven membrane 10135).Because the woven membrane 10135 is held in a taut position by a former and may be generally flat along the lateral direction, crimping of the bridge regions 6106 may be unnecessary. The bridge regions 6106 may be placed under tension without crimping and may provide substantially the same benefits as crimped bridge regions. As noted above, because the first sealing structure 6131 may not include complex curvatures, it may be easier to manufacture the woven membrane 10135 into the first sealing structure 6131, as opposed to a first sealing structure on another patient interface (e.g., 9000).

[0454] By using two separate pieces of woven membrane 10135 to form the patient interface (e.g., 9000, 21000), overlapping of the woven material 10135 can be avoided. In particular, overlapping can be problematic when attempting to impart complex curvatures onto a large piece of woven membrane 10135 because longer curvatures may be possible, resulting in a greater likelihood of the woven membrane 10135 folding over itself. Because the patient interface 6000 does not include complex curvatures, overlapping of the woven material 10135 can also be less likely. However, when two separate pieces of woven material 10135 are used, the patient interface 6000 can include a substantially planar surface of the first sealing structure 6131 oriented in a first direction and a substantially planar surface of the second sealing structure 6132 in a second direction. In other words, because the patient interface 6000 is constructed from separate woven membranes 10135, the separate pieces of woven membrane 10135 can be positioned in different orientations to better fit the patient's face.

[0455] One way to overcome this overlap problem has been to stack multiple pieces of woven membranes 10135 on top of each other (e.g., by creating an overlap of several millimeters between two or more woven membranes 10135) to create complex curvatures while reducing the stresses generated in each woven membrane 10135 (e.g., compared to a single woven membrane 10135). However, leakage can occur in the overlap areas, leading to a poor seal in the final patient interface 9000, 21000, etc.

[0456] When two separate but non-overlapping pieces of woven membrane 10135 are used, the length of each individual curve is reduced, reducing the likelihood of a single piece of woven membrane 10135 folding over itself. Additionally, in instances where the woven membranes 10135 overlap, the elimination of overlapping interfaces of the woven membranes 10135 may allow for a reduced likelihood of leakage.

[0457] Two spaced-apart pieces of the woven membrane 10135 may be used, and the flexible material may be molded into the space between the two woven membranes 10135. As shown, this space may be relatively small (e.g., to reduce contact between the patient's skin and the support structures 9120 and 21120). As a result, molding this component of the patient interface (e.g., 9000, 21000) may be difficult (e.g., due to the need for precision in positioning the woven membrane 10135, the need to fill the space with flexible material without covering the woven layer 10133, etc.), but it may also increase the likelihood that the patient interface (e.g., 9000, 21000) will not contain wrinkles that form due to complex curvatures imparted to the woven membrane 10135. Similar principles may apply to the patient interface 6000 even if the first sealing portion 6131 does not have a complex curvature.

[0458] In this example, there is a direct trade-off between manufacturability and overall textile contact. For example, the patient interface 9000 shown in Figure 35 (or the patient interface 6000 in Figure 33) may be easier to manufacture than the patient interface 21000 shown in Figure 33-1 (e.g., because liquid materials cannot be molded into small spaces). However, in the example shown in Figure 35, the patient's upper lip (e.g., near the philtrum) will come into contact with a larger surface area of the support structure 9120 (i.e., not the textile layer 10133), resulting in a lower patient comfort level than the patient interface 21000 of Figure 33-1.

[0459] The example of the patient interface 23000 shown in FIG. 33-2 may attempt to balance the issues seen in the patient interface 9000 of FIG. 34 (or 6000 of FIG. 33) and the patient interface 21000 of FIG. 33-1. In other words, the patient interface 23000 of FIG. 33-2 may attempt to reduce manufacturing complexity without sacrificing patient comfort. To that end, the second woven membrane 10133 may include a U-shaped or C-shaped shape (e.g., similar to the examples shown in FIGS. 33 and 35). The U-shaped woven membrane 10135 includes an outer edge 23180 that forms part of the periphery of the lower sealing portion 23130b and an inner edge 23182 that forms part of the mouth area 23104. The first woven membrane 10135 forms the upper sealing portion 23130a in FIG. 33-2 and may be larger than the first woven membrane 10135 forming the upper sealing portion 21130a in FIG. 33-1 such that the lower edge 23184 of the first woven membrane 10135 may be aligned with the inner edge 23182 of the second woven membrane 10135. In other words, in contrast to the support structure 23120, substantially the entire periphery of the mouth area 23104 includes the woven membrane 10135. Because the woven membrane 10135 is a separate piece, gaps 23190 filled with flexible material may exist between the individual pieces (i.e., between the upper sealing portion 23130a and the lower sealing portion 23130a). These gaps 23190 are generally longitudinal (e.g., left / right) and extend at least between the outer edge 23180 and the inner edge 23182. These gaps 23190 may be small enough that their presence does not affect patient comfort (e.g., the patient may not feel the support structure 23120 between the sealing portions 23130a and 23130b and may feel as if only the fabric material is in contact with their perioral area). In some examples, the gaps 23190 are substantially small so that the patient cannot detect their presence.

[0460] Within the mold, the woven membrane 10135 is positioned in the manner described above, and a flexible material is introduced into the mold to form the patient interface 23000. Because the lower edge 23184 of the first woven membrane 10135 extends to the inner edge 23182 of the second woven membrane, no flexible material is introduced into the mold in the region between the nostril openings 23103 and the mouth area 23104. In other words, the woven membrane 11035 is the only material configured to contact the upper lip (e.g., relative to the philtrum) in this region. Although the flexible material allows for flexion and movement, using a combination of the woven membrane 10135 and a flexible material may lead to a decrease in the resilience of the patient interface 23000. For example, during the molding process, the flexible material may solidify on the inner surface of the woven membrane 10135 (i.e., within the cavity 23001), resulting in an increase in thickness in this region. In use, when the patient's upper lip contacts this area, it may be more difficult for the patient interface 23000 to flex, which may result in an incomplete seal (i.e., leakage). By eliminating the need for a support area between the nostril openings 23103 and the mouth area 23104, the need for flexible material to flow in this area may be eliminated and the thickness of the woven membrane 10135 may be substantially eliminated. When the woven membrane 10135 is not substantially supported by a flexible material (e.g., as in FIG. 33-1 ), the woven membrane 10135 may stretch similarly to a patient interface constructed entirely from silicone (e.g., 0.3 mm thick silicone), allowing the woven membrane 10135 to achieve substantially the same or similar seal against the patient's face as an entire silicone membrane.

[0461] For the manufacture of this patient interface 23000, the woven membrane 10135 may be substantially flat (e.g., a two-dimensional shape) before being placed into a mold and may assume a complex curvature as a result of being placed into the mold. A liquid flexible material may be added to form the three-dimensional patient interface 23000 (e.g., to maintain the complex curvature in the woven membrane 10135 after being removed from the mold). As noted above, the addition of any crimps may occur before or after the woven membrane 10135 is placed into the mold.

[0462] As shown in FIG. 33-3 , the patient interface 25000 may be formed using a single woven membrane 10135 when constructing the sealing portion 25130. In other words, a single woven membrane 10135 is used to seal around both the patient's nares and the patient's mouth. The sealing portion 25000 includes an upper sealing portion 25130a and a lower sealing portion 25130b. The periphery of the sealing portion 25130 is substantially the same as in the above example. However, in this example, when spacing and connecting the first and second woven membranes 10135, it is not necessary to form a support structure 25120 between the first and second woven membranes 10135. This may make manufacturing easier because it is no longer necessary to properly space and fill the woven membranes with a liquid-type material. Additionally, the entire area of the patient interface 25000 that contacts the patient near the mouth and / or nose is constructed from the fabric layer 10133. As a result, the support structure 25120 does not contact the patient near the upper lip, which may help improve patient comfort.

[0463] The crimping methods described above may reduce or eliminate the possibility of a single woven membrane 10135 folding over itself (e.g., compared to the example shown in FIGS. 33-1 and 33-2), even when using larger pieces of woven membrane 10135. In particular, crimping may reduce or eliminate overlap in the nose region (where more curvature is applied).

[0464] Furthermore, there may be no significant reduction in the seal of the resulting patient interface (e.g., compared to interfaces 21000 and 23000 of FIGS. 33-1 and 33-2). While the woven membrane 10135 in FIG. 33-3 may include a woven layer 10133 supported by an impermeable layer 10131, the entire woven membrane 10135 may be unsupported (e.g., unsupported by the flexible material of the support structure 25120). Because the woven membrane 10135 may be able to stretch an amount similar to silicone alone (e.g., the impermeable layer 10131 may not significantly reduce the extensibility of the woven membrane 10135), it may be able to accommodate various contours along the patient's face (e.g., near the patient's alae of the nose), which may assist in seal formation.

[0465] To reduce and / or eliminate the occurrence of leakage when wearing the patient interface 25000, the shape of the woven membrane 10135 may be modified to better accommodate a wider range of patient faces and limit the occurrence of leakage (see, for example, FIGS. 33-4-33-5). In one example, the modification of the woven membrane 10135 may include reducing the radius of curvature of the upper sealing portion 25130a. Reducing the radius of curvature provides a deeper pocket or nose radius for receiving the patient's face. For example, the portion of the upper sealing portion 25130a that receives the patient's nose may be made narrower, such that when the patient's nose contacts the fabric layer 10133 of the sealing portion 25130, the woven membrane 10135 fits more snugly against the patient's nose. This may be particularly useful for patients with smaller and / or narrower noses (for whom a sealing portion 25130 with a larger radius of curvature would be too loose to fit). Because the woven membrane 10135 can flex and deform, patients with slightly larger noses may be able to use the patient interface 25000 and may be able to obtain a tighter fit (e.g., to reduce leakage).

[0466] Additionally, the radius of curvature of the upper sealing portion 25130a can be reduced while still achieving a similar shape at the junction between the sealing portion 25130 and the support structure 25120. Because the upper sealing portion 25130a and the support structure 25120 are connected, the support structure 25120 can be pulled in the direction of the deep pocket formed in the upper sealing portion 25130a.

[0467] The reduced radius of curvature of the upper sealing portion 25130a may result in a similar shape in the lower sealing portion 25130b since the upper sealing portion 25130a and the lower sealing portion 25130b are formed from one piece of the same textile membrane 10135. In particular, this may lead to a reduced curvature at the lower end of the lower sealing portion 25130b (e.g., in the area configured to contact the patient's chin), which may also result in similar benefits of the deeper pocket described above.

[0468] In some examples, the radius of curvature may be adjusted about the third axis 13000. In other words, the lateral sides 25250 and / or corner regions 25252 of the patient interface 25000 may be closer together and the patient may need to seat their nose further into the cushion assembly 25105 to contact the bridge portion 25106. Additionally, the radius of curvature about the fifth axis 15000 may be increased, thereby decreasing the curvature. Increasing the radius of curvature about the fifth axis 15000 helps maintain a deep curvature about the third axis 13000 because the fifth curvature 50000 does not flatten the third curvature 30000 (e.g., because the third curvature 30000 and the fifth curvature 50000 are about non-parallel axes).

[0469] In some examples, the radius of curvature about the third axis may be less than approximately 40 mm. In some examples, the radius of curvature about the third axis may be less than approximately 30 mm. In some examples, the radius of curvature about the third axis may be between approximately 25 mm and approximately 15 mm. In some examples, the radius of curvature about the third axis may be approximately 20 mm. This radius of curvature may be only in the textile membrane 10135. A reduced radius of curvature may secure the patient's nose with a tighter fit within the sealing portion, reducing leakage. A reduced radius of curvature may also assist the patient in more accurately positioning their nose relative to the patient interface 25000 (e.g., to more accurately align their nostrils with each nostril opening 25103) by reducing the space available for the patient's nose to move laterally (e.g., slide and / or shift) relative to the patient interface 25000.

[0470] Reinforcement of the sealing portion 25130 and / or support structure 25120 may also prevent and / or reduce leakage. As shown in FIG. 33-6 , support ribs 25186 may be added within the cavity 25001 to increase the localized stiffness of the patient interface and improve the seal against the patient's skin. In some examples, the support ribs 25186 may be positioned and / or enlarged to increase the localized stiffness. In some examples, the support ribs 25186 are enlarged by the addition of secondary ribs 25188. In some examples, the support ribs 25186 are enlarged by increasing their width. In some examples, the support ribs 25186 are enlarged by increasing their length.

[0471] In one example, the support rib 25186 is molded into the patient interface 25000 within the cavity 25001, and the secondary rib 25188 is molded to an end of the support rib 25186. One end of the support rib 25186 may contact the impermeable layer 10131 of the sealing portion 25130, and the secondary rib 25188 may be molded to the other end of the support rib 25186. The support rib 25186 and the secondary rib 25188 together may form an L-shape. The support rib 251816 may intersect the secondary rib in a generally perpendicular relationship. The secondary rib 25188 may be parallel to at least a portion of the sealing portion 25130. In the illustrated example, the patient interface may include two support ribs 25186 (any number is acceptable). Each support rib 25186 connects to the sealing portion 25130. The inner end of each support rib 25186 may extend approximately 2 mm to approximately 8 mm from the inner edge of the sealing portion 25130 (e.g., the free end adjacent the opening to the cavity 25001). Each secondary rib 25188 may not extend further so as not to block airflow through the nostril openings 25103. A single secondary rib 25188 may extend between two support ribs 25186. The ends of the secondary ribs 25188 may connect to the impermeable layer 10131 of the sealing portion 25130 so that the secondary ribs 25186 follow a precise pattern. In other examples, the secondary ribs 25188 may not extend beyond the farthest support rib 25186. In other words, the distance between the support ribs 25186 may be approximately the length of the secondary ribs 25188.

[0472] The provision of the secondary ribs 25188 may improve sealing of the patient interface 25000 when worn by a patient. Specifically, the stiffness of the sealing portion 25130 may be increased. For example, the portion of the sealing portion 25130 configured to contact the upper lip may have increased stiffness due to the support ribs 25186 and / or the secondary ribs 25188. The distance between the support ribs 25186 and the number of support ribs 25186 may affect the overall increase in stiffness. In other words, increasing the number of support ribs 25186 and / or decreasing the distance between adjacent support ribs 25186 increases the stiffness of the sealing portion 25130. The secondary ribs 25188 may act as a backstop and help limit compression of the support ribs 25186 (e.g., due to contact with the patient's face). The increased stiffness may help maintain the shape of different curvatures and provide an ideal fit for the patient. For example, ribs 25186 and 25188 help maintain a variable radius of curvature of sealing portion 25130, limiting the occurrence of wrinkles or creases in order to limit the occurrence of leaks.

[0473] In one example (see, e.g., FIG. 33-7), the support ribs 25186 are molded into the patient interface 25000 within the cavity 25001, and have a length greater than that shown in FIG. 33-6. Wider support ribs 25186 may be molded with or without secondary ribs 25188. Increasing the width of the support ribs 25186 reduces the likelihood of the support ribs 25186 buckling when the patient interface 25000 is worn by a patient. This increases the stiffness of the support ribs 25186, and therefore reduces the likelihood of wrinkles and / or creases in the sealing portion 25130. Providing the secondary ribs 25188 with wider support ribs 25186 may increase the stiffness of the sealing portion 25130 (more than with just one of these modifications). However, increasing the thickness of the support rib 25186 may specifically increase stiffness where the support rib 25186 is attached to the sealing portion 25130 (i.e., a localized increase in stiffness), as opposed to the secondary ribs 25188, which increase stiffness around a larger area of the sealing portion 25130.

[0474] In one example, the support ribs 25186, when molded into the patient interface 25000 within the cavity 25001, are longer in length than the length shown in FIG. 33-7. The longer support ribs 25186 may be molded with or without the secondary ribs 25188 and / or with or without the wider support ribs 25186. In some embodiments, the length of each of the support ribs 25186 may increase by approximately 0.1 mm to approximately 8 mm. In some embodiments, the length of each of the support ribs 25186 may increase by approximately 0.5 mm to approximately 5 mm. In some embodiments, the length of each of the support ribs 25186 may increase by approximately 1 mm to approximately 3 mm. In some embodiments, the length of each of the support ribs 25186 may increase by approximately 2.5 mm. Elongating the support rib 25186 may provide additional support to the portion of the sealing portion 25130 that may contact the patient's upper lip along the third curvature 30000.

[0475] Altering the shape of the patient interface 25000 may also avoid and / or reduce leakage (see, e.g., FIGS. 33-8 and 33-9). For example, the shape and / or contour of the lateral sides 25250 and / or corner regions 25252 of the sealing portion 25130 may be adjusted to better fit the patient's face (e.g., near the corners of the nose or alar region). Altering the shape of the sealing portion 25130 may be accomplished by altering the shape of the support structure 25120. The shape of the support structure 25120 changes along with the shape of the sealing portion 25130, as the support structure 25120 helps determine where to place the sealing portion 25130.

[0476] In some examples, the first curvature 10000 can be adjusted to help improve the seal against the patient. Specifically, the magnitude of the first curvature 10000 can be more negative about the first axis 11000 (i.e., more negative than in the example above). As noted above, the lateral sides 25250 and / or corner regions 25252 are disposed on the sealing portion 25130 near the transition between the positive curvature about the third axis 13000 (i.e., the third curvature) and the first curvature 10000. Increasing the magnitude of the first curvature 10000 can make the positive dome shape more pronounced (e.g., the curvature becomes steeper). This may reduce the width between opposing lateral sides 25250, which may result in a tighter fit to the patient wearing the patient interface 25000, thereby limiting the patient's nose from pressing against and displacing the sealing portion 25130.

[0477] The shape of the support structure 25120 can also be adjusted to limit and / or prevent leakage. Changing the shape of the support structure 25120 (e.g., molding a negative curvature with a larger magnitude) can also allow for a change in the shape of the sealing portion 25130 as the support structure 25120 is molded into the sealing portion 25130. This is shown in more detail in FIG. 33-9, which shows sealing portion 25130-1 after shape modification and sealing portion 25130 before shape modification. Creating a larger positive dome shape in the support structure 25120 can have a similar effect as that described above for sealing portion 25130.

[0478] As shown in FIG. 33-10, increasing the upper vector of the patient interface 25000 can prevent and / or limit leakage. Similar to the patient interface 9000 shown in FIG. 24, the positioning and stabilizing structure 9300 can engage the patient interface 25000 at four contact points (i.e., two points on either side) with the plenum chamber 25200 and / or the seal-forming structure 25100. For example, the clip 9301 and conduit 9900 (see, e.g., FIG. 24) connect on the left and right sides of the cushion assembly 25105. During wear, the patient can adjust the length of the upper strap 9302 and / or stretch the conduit 9900 (e.g., due to an elastomeric material, bellows, etc.) to pull the cushion assembly 25105 onto the patient's face. The pulling force from the positioning and stabilizing structure 9300 assists in forming a seal between the sealing portion 25130 (see, e.g., FIG. 33-3) and the patient's face.

[0479] Changing the location where the clip 9301 and / or conduit 9900 connect to the cushion assembly 25105 can allow for improved sealing from tension forces. For example, a patient may be able to achieve a tighter seal against their face by changing the vector position. This can be achieved by spacing the connection points of the clip 9301 and conduit 9900 farther apart (i.e., on either lateral side). In one example, the connection point of the conduit 9900 is elevated from the example position shown in FIG. 24 (e.g., positioned closer to the tip of the nose when worn). Elevating the location where the conduit 9900 connects to the cushion assembly 25105 allows the force provided by the conduit 9900 to act more directly on the nasal region of the cushion assembly 25105 (e.g., near the nostril openings 25103). Additionally, raising the conduit connection point may cause the force applied by the conduit to be more localized (e.g., a greater component of the force applied at that location) around the nostril opening 25103. Because patients' noses have varying geometries, concentrating a greater portion of the force from the conduit 9900 may allow the sealing portion 25130 to more precisely conform to the geometry of the patient's face.

[0480] As shown in FIG. 33-10, the upper vector can be raised from a first height H1 to a second height H2. The second height H2 is closer to the nostril opening 25103 than the first height H1. In some examples, the distance between the first height H1 and the second height H2 is at least approximately 0.5 mm. In some examples, the distance between the first height H1 and the second height H2 is between approximately 1 mm and approximately 10 mm. In some examples, the distance between the first height H1 and the second height H2 is between approximately 2 mm and approximately 8 mm. In some examples, the distance between the first height H1 and the second height H2 is between approximately 3 mm and approximately 5 mm. In some examples, the distance between the first height H1 and the second height H2 is approximately 4 mm.

[0481] As shown in FIG. 33-11 , adding an insert 25194 to the surface of the cushion assembly 25105 can prevent and / or limit leakage. In some examples, the insert 25194 can be constructed of a foam material and can be disposed on the outer surface of the sealing portion 25130 (e.g., in contact with the fabric layer 10133). The insert 25194 can be disposed on the surface of the support structure 25120 in addition to and / or instead of being disposed on the sealing portion 25130.

[0482] The inserts 25194 may be positioned anywhere along the cushion assembly 25105. In the illustrated example, the inserts 25194 may be positioned in discrete locations throughout the cushion assembly 25105, particularly in areas prone to leaks. For example, they may be positioned near the lateral sides 25150 and / or corner regions 25252 configured to contact the alar regions of the patient's face. These inserts may be able to conform to the complex facial geometry of the patient to form a tighter seal and reduce gaps that could serve as pathways for air escape. In some examples, when the cushion assembly 25105 is worn by a patient, the foam is not exposed to the atmosphere. As such, the inserts 25194 provide additional material for a tighter fit in some areas, but without providing pathways that could serve as a path for air leakage.

[0483] In some examples, the insert 25194 is permanently secured to the cushion assembly 25105. For example, the insert 25194 is glued or otherwise secured to the surface of the cushion assembly 25105, preventing the patient from removing the insert 25194 (without damaging the cushion assembly 25105). In other examples, the insert 25194 may be removable, allowing the patient to position the insert 25194 in various locations or to remove the insert 25194 entirely.

[0484] Any combination of the leakage prevention and / or reduction examples in FIGS. 33-1 through 33-11 described above may be used in a single cushion assembly 25105. Using several of the above examples may provide further improvements in preventing and / or limiting leakage. However, some patients may not experience substantial leakage of pressurized air and may not need any of the cushion assemblies 25105 described above. For example, patients with larger noses may have a more secure fit with the unmodified cushion assemblies 6105 and 9105, or their nose may fit too tightly with the modified cushion assembly 25105.

[0485] 5.3.4.1.2 Example of a woven membrane Exemplary properties and structural configurations of woven composites used as materials for woven membranes are described below.

[0486] 5.3.4.1.2.1 Textile composite structure Various combinations of textile materials and membrane / film layers can be used.In one example, a three-layer configuration is used, in which a thermoplastic polyurethane (TPU) film is placed between two textile layers (for example, nylon, a mixture of nylon and polyester, a mixture of nylon and spandex, a mixture of polyester and spandex, or a mixture of nylon / polyester / spandex).An additional textile layer is required to protect the TPU film from damage (for example, during cleaning).

[0487] In another example, a two-layer configuration is used that includes a fabric (e.g., nylon, a blend of nylon and polyester, a blend of nylon and spandex, a blend of polyester and spandex, or a blend of nylon / polyester / spandex) with a silicone layer (e.g., deposited as a coating). This composite material can be less expensive than the three-layer configuration described above because only one layer of fabric is required.

[0488] In another example, a woven material (eg, a microfiber or polyurethane material) may be coated with a polyurethane film to form a two-layer arrangement.

[0489] 5.3.4.1.2.2 Textile materials As noted above, multiple woven materials can be used to form the sealing portion (e.g., nylon, polyester, spandex, blends of nylon and polyester, blends of nylon and spandex, blends of polyester and spandex, blends of nylon / polyester / spandex, microfiber, or polyurethane).

[0490] In one example, a nylon material is used. Nylon is softer than polyester, which can provide comfort benefits to the patient. Nylon is also stronger than polyester, which can provide increased longevity and durability. Additionally, nylon has a higher melting temperature compared to polyester, allowing it to withstand higher temperature manufacturing conditions.

[0491] In another example, a nylon and polyester blend material is used. This material is more desirable because it is less irritating to the patient due to lower moisture absorption caused by the addition of polyester. The nylon and polyester blend is also less expensive than nylon.

[0492] 5.3.4.1.2.3 Overall thickness of the fabric composite Thicker woven membrane thicknesses (e.g., 0.5 mm) can be stronger and leave less residue. These woven membranes can be easier to handle during manufacturing because they are less likely to flap.

[0493] A mid-level thickness (e.g., 0.35 mm to 0.45 mm) may result in a flexible, lightweight structure that is relatively easy to handle during manufacturing and may provide greater comfort to the patient than thicker woven membranes.

[0494] Thinner woven membranes may result in a very lightweight construction and provide a soft, comfortable feel to the patient, but may be less durable than thicker woven membranes.

[0495] 5.3.4.1.2.4 Knitting structure The textile material of the textile membrane can have, for example, a weft-knitted or warp-knitted structure. Textile materials with weft-knitted and / or warp-knitted structures can be considered stretch-type textiles. Weft-knitted textiles are more desirable because they provide a material with greater elasticity than warp-knitted textiles. The knitted textile stretches when the patient's face engages with the textile membrane, reducing the force exerted by the textile membrane on the patient's face and providing greater comfort to the patient.

[0496] In one example, the weft direction (the direction of path 80) may extend across the width of the woven fabric membrane, as the weft direction may have higher elasticity or extensibility, or the weft direction may extend across the length of the nose (up and down).

[0497] Additionally, weft knitting is better suited to producing relatively thin materials, such as those disclosed herein, and is generally less expensive than warp knitting.

[0498] However, in some instances warp knitting is more desirable because it shrinks less than weft knitted materials.

[0499] In some examples, the textile membrane may include any braided structure that allows for stretching of the textile membrane.

[0500] In other examples, a woven membrane may include a different structure (eg, a woven fabric) but may also be considered an extended woven fabric.

[0501] 5.3.4.1.2.5 Knitting machines Weft-knitted textile materials can have a single jersey knit construction, providing technical and back technical faces with different appearances. The single jersey knit can be formed by a single set of needles, providing a knit stitch on the technical face (front) and a purl stitch on the back technical face. In one example, the technical face can form the outer surface of a textile membrane, and an air-impermeable membrane can be attached to the back technical face. Alternatively, the technical face can be oriented toward the inner surface of the textile membran...

Claims

1. 1. A cushion assembly for delivering a continuous positive pressure air flow relative to ambient air pressure to an inlet to a patient's nares and an inlet to a patient's mouth, comprising: The cushion assembly includes: at least 6 cmH above the ambient air pressure ２ a plenum chamber at least partially defining a cavity pressurizable to an elevated therapeutic pressure, said plenum chamber including at least one plenum chamber inlet port sized and configured to receive an air flow at said therapeutic pressure for breathing by a patient; a seal-forming structure including a silicone support structure and a textile membrane, the textile membrane constructed and arranged to form a pressure-assisted seal with a patient's face in use; Equipped with The woven membrane is a nose section configured to form the pressure-assisted seal in use with areas of the patient's face around entrances to the patient's nares, the nose section including two nostril openings and a bridge section located between the two nostril openings, the two nostril openings positioned to deliver airflow to the entrances to the patient's nares in use; a mouth section configured to form, in use, the pressure-assisted seal with an area of the patient's face about an entrance to the patient's mouth, the mouth section including a mouth section hole formed therein such that the mouth section surrounds the mouth section hole, the mouth section hole being arranged to deliver airflow to the entrance to the patient's mouth in use; Equipped with The cushion assembly, wherein the textile membrane is attached to the silicone support structure along a periphery of the textile membrane such that the textile membrane extends radially inward beyond the silicone support structure.

2. The cushion assembly of claim 1 , wherein the nose section is configured to form a seal, in use, only with the portion of the patient's face below the patient's nasal bridge region.

3. The cushion assembly of claim 2 , wherein the nasal region is configured to form a seal with the underside of the patient's nose at or below the patient's nasal tip in use.

4. The cushion assembly of claim 1 , wherein the bridge portion restricts entry of the patient's nose into the cavity during use.

5. The cushion assembly of claim 1 , wherein the textile membrane is air impermeable.

6. the textile membrane is connected to the silicone support structure at an overlap region; The cushion assembly of claim 1 , wherein the textile membrane comprises a textile material that overlaps an edge of the silicone support structure.

7. The woven membrane is A textile material; an air impermeable layer; The cushion assembly of claim 1 , comprising:

8. 8. The cushion assembly of claim 6 or 7, wherein the textile material is a single continuous piece of material and is used to form both the nose and mouth regions of the textile membrane.

9. The cushion assembly of claim 1 , wherein the at least one plenum chamber inlet port comprises two plenum chamber inlet ports formed on either side of the plenum chamber.

10. 10. The cushion assembly of claim 1, wherein each of the nostril openings is configured to be positioned adjacent one of the patient's nostrils in use.

11. The cushion assembly of claim 1 , wherein the textile membrane includes a first portion and a second portion, and the seal-forming structure has a three-dimensional shape with multiple curvatures.

12. The cushion assembly of claim 11 , wherein the bridge region is the second portion.

13. 13. The cushion assembly of claim 11 or 12, wherein the first portion comprises at least part of the mouth area.

14. 14. The cushion assembly of any one of claims 11 to 13, wherein the silicone support structure is configured to hold the textile membrane in the three-dimensional shape.

15. 15. The cushion assembly of claim 1, wherein the seal-forming structure includes a pair of ribs projecting inwardly into the cavity from an inner surface of a support structure on each side of the plenum chamber, the ribs configured to increase stiffness of the cushion assembly.

16. 16. The cushion assembly of claim 1, wherein the nose region is configured to press against the patient's face such that the patient's nose is not received within the cavity.

17. 17. The cushion assembly of claim 1, wherein only the textile membrane of the cushion assembly seals with the patient's face.

18. 1. A patient interface for delivering a positive pressure airflow to a patient for treating sleep disordered breathing, the patient interface comprising: A cushion assembly according to any one of claims 1 to 17; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head; a patient interface including:

19. the positioning and stabilising structure comprising a pair of conduits for delivering air flow to the cushion assembly in use; 20. A patient interface according to claim 18, wherein the pair of conduits are configured to extend along either side of the patient's head when the patient interface is worn.

20. the at least one plenum chamber inlet port includes two plenum chamber inlet ports formed on either side of the plenum chamber; 20. A patient interface according to claim 19, wherein the conduits are configured to connect to respective ones of the plenum chamber inlet ports.

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