Textile seal-forming structure with multiple curvatures

Abstract

To provide a textile seal-forming structure with multiple curvatures.SOLUTION: A patient interface includes a seal-forming structure with a textile membrane which has at least one hole so that the flow of air at a therapeutic pressure is delivered to at least an entrance to the patient's nares and or the patient's mouth. The seal-forming structure is constructed and arranged to maintain the therapeutic pressure in a cavity of a plenum chamber throughout the patient's respiratory cycle in use. The textile membrane includes a first portion that is held in a relaxed state and a second portion that is held in a taut state. The taut state of the second portion is configured to allow the seal-forming structure to include a three-dimensional shape that has multiple curvatures.SELECTED DRAWING: Figure 12

Description

Technical Field

[0001] 1 Cross - reference to related applications This application claims priority to Australian Provisional Application No. 2020902371, filed on July 9, 2020, and U.S. Patent Application No. 16 / 850,803, filed on April 16, 2020 (which is a continuation - in - part of International Patent Application No. PCT / IB2019 / 058832, filed on October 16, 2019), and the entire contents of each of these documents are incorporated herein by reference in their entirety for all purposes.

[0002] International Patent Application No. PCT / IB2019 / 058832 claims the benefit of U.S. Provisional Application No. 62 / 805,147, filed on March 13, 2019, and also claims the benefit of Australian Provisional Application No. AU2018904886, filed on December 21, 2018, and Australian Provisional Application No. AU2018903752, filed on October 16, 2018. The entire contents of each of these documents are incorporated herein by reference in their entirety for all purposes.

Background Art

[0003] 2 Background of the technology 2.1 Field of the technology This technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and ameliorating respiratory - related diseases. This technology also relates to medical devices or apparatuses and their use.

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

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

[0006] A range of respiratory diseases exist. Certain diseases can be characterized by specific manifestations (e.g., apnea, hypopnea, and hyperventilation).

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

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by manifestations such as closure or obstruction of the upper airway during sleep. This is the result of a combination of an abnormally small upper airway and the normal loss of muscle tone in the tongue region, and the normal loss of the soft palate and posterior oropharyngeal wall during sleep. Due to such a condition, the breathing cessation of affected patients typically lasts for 30 - 120 seconds, and sometimes the breathing stops 200 - 300 times a night. As a result, excessive daytime sleepiness occurs, which can cause cardiovascular diseases and brain damage. This syndrome is a common disease, especially common in middle-aged overweight men, but patients may have no awareness of the symptoms. See U.S. Patent No. 4,944,310 (Sullivan).

[0009] Respiratory insufficiency is a general term for respiratory disorders, indicating that the lungs are unable to perform sufficient oxygen inhalation or sufficient CO2 exhalation to meet the patient's needs. Respiratory insufficiency may include some or all of the following diseases.

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

[0011] To treat or improve such conditions, a certain range of treatments are being used. Furthermore, in other aspects, even healthy individuals can advantageously utilize preventive and therapeutic treatments for respiratory diseases. However, there are several drawbacks in these.

[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 being used for the treatment of one or more of the above-mentioned respiratory diseases.

[0013] 2.2.2.1 Respiratory pressure therapy Respiratory pressure therapy is the application of supplying air to the entrance of the airway at a controlled target pressure that is normally positive pressure with respect to the atmosphere over the entire respiratory cycle of the patient.

[0014] Nasal continuous positive airway pressure (CPAP) therapy is being used in the treatment of obstructive sleep apnea (OSA). As its mechanism of action, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, the continuous positive airway pressure therapy functions as an air sprint, thereby preventing the closure of the upper airway. Since the treatment of OSA by CPAP therapy can be spontaneous, if such a patient notices one or more of the following regarding the device used for treatment provision, the patient may choose not to comply with the treatment: discomfort, difficulty in use, high cost, lack of aesthetic appeal.

[0015] 2.2.2.2 Flow therapy In all respiratory therapies, the delivery of a defined therapeutic pressure is not necessarily intended. In some respiratory therapies, the delivery of a defined tidal volume is intended by delivering an inspiratory flow profile (possibly superimposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy by the flow of conditioned or high-concentration gas can only be used as an adjunct to the patient's own spontaneous breathing. In one embodiment, high-flow therapy (HFT) is the provision of a continuous, heated, humidified air flow at a "therapy flow rate" that is maintained substantially constant throughout the respiratory cycle through an unsealed or open patient interface. The therapy flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT is used for the treatment of OSA, CSR, respiratory insufficiency, COPD, and other respiratory disorders. As one mechanism of action, providing high-flow air to the airway inlet improves ventilation efficiency because it enables the flushing or washing out of CO2 exhaled from the patient's anatomic dead space. For this reason, HFT is sometimes referred to as dead space therapy (DST). Other benefits include improved warmth and humidification (possibly due to the benefits of secretion control) and the possibility of a gentle increase in airway pressure. As an alternative to a constant flow rate, the therapy flow rate can follow a profile that varies over the respiratory cycle.

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

[0017] 2.2.2.3 Supplemental Oxygen In the case of a particular patient, a combination of oxygen therapy and respiratory pressure therapy or HFT can be obtained by adding supplemental oxygen to a pressurized air flow. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is referred to as HFT with supplemental oxygen.

[0018] 2.2.3 Respiratory Therapy System These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used for screening, diagnosing, or monitoring without treating a disease.

[0019] A respiratory therapy system can 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 can be used to provide an interface to a breathing apparatus to a wearer, for example, by providing an air flow to the airway inlet. The air flow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can, for example, form a seal with the area of the patient's face, thereby facilitating gas delivery at a sufficient distributed pressure together with the atmospheric pressure for therapy execution (e.g., at a positive pressure of about 10 cmH2O relative to the atmospheric pressure). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate delivery of the gas supply to the airway at a positive pressure of about 10 cmH2O. In the case of flow therapy such as nasal HFT, the patient interface is configured to deliver air to the nostrils (and clearly avoid a complete seal). An example of such a patient interface is a nasal cannula.

[0021] Certain other mask systems may be functionally inappropriate in this field. For example, in the case of a mask for purely decorative purposes, it may not be possible to maintain an appropriate pressure. A mask system used for underwater swimming or diving can be configured to protect against water ingress from higher external pressures and not maintain internal air at a pressure higher than the surroundings.

[0022] Certain masks may be clinically unfavorable in this technology (for example, when the mask blocks airflow through the nose and only allows airflow through the mouth).

[0023] In certain masks, it may be uncomfortable or impractical in this technology when the patient has to insert part of the mask structure into the mouth and create and maintain a seal through the lips.

[0024] Certain masks may be impractical for use during sleep (for example, when sleeping on the side in bed with the head on a pillow).

[0025] There are multiple challenges in the design of a patient interface. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout the respiratory therapy period.

[0026] Due to these problems, in some cases, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more reasons such as being overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of the wrong size is used, it can lead to a decrease in compliance, comfort, and patient prognosis. Masks designed for pilots, personal protective equipment (e.g., filter masks), masks designed as part of a SCUBA mask, or masks for anesthesia administration can withstand their original uses, but in such cases, they may be unacceptably uncomfortable for long-term (e.g., several hours) wear. Due to such discomfort, the patient's compliance with treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0027] CPAP treatment is extremely effective in the treatment of certain respiratory diseases when the patient is committed to the treatment. If the mask is uncomfortable or difficult to use, the patient may not commit to the treatment. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect the patient's compliance.

[0028] Masks for other uses (e.g., pilots) may not be suitable for use in the treatment of sleep apnea, so masks designed for use in the treatment of sleep apnea 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-forming structure The patient interface may include a seal-forming structure. Since the patient interface directly contacts the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0031] The patient interface may be partially characterized according to the design intent of where the seal-forming structure engages the face during use. In one form of the patient interface, the seal-forming structure may include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to be placed, for example, on the upper lip region and nasal bridge region of the face. In one form of the patient interface, the seal-forming structure may include an element that surrounds the mouth region by forming a seal, for example, on the lower lip region of the face during use. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces may be known by various names such as nasal masks, full-face masks, nasal pillows, nasal puffs, and oro-nasal masks by their manufacturers.

[0032] A seal-forming structure that may be effective in one region of the patient's face may be inappropriate in another region, for example, due to different shapes, structures, variability, and sensitive regions of the patient's face. For example, the seal of a swimming goggle placed on the patient's forehead may be inappropriate for use on the patient's nose.

[0033] A particular seal-forming structure can be designed for mass production to fit one design for a wide range of different face shapes and sizes and be comfortable and effective. To form a seal, it may be necessary to conform one or both of the patient's face shape and the seal-forming structure of the mass-produced patient interface to the extent of the mismatch between them.

[0034] One type of seal-forming structure extends around the perimeter of the patient interface and is intended to seal the patient's face when a force is applied to the patient interface while the seal-forming structure is engaged against the patient's face. This seal-forming structure can include an air or fluid-filled cushion or can include a formed or shaped surface of an elastic sealing element composed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inappropriate, a gap can occur between the seal-forming structure and the face, and additional force is required to press the patient interface against the face to achieve a seal.

[0035] Another type of seal-forming structure uses a thin flap seal disposed around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previously described type of seal-forming portion, if the alignment between the face and the mask is not good, additional force may be required to achieve a seal or leakage may occur from the mask. Further, if the shape of the seal-forming structure does not conform to the shape of the patient, creases or buckling can occur in the seal-forming portion during use, causing leakage.

[0036] Another type of seal-forming structure can include friction fit elements that are inserted, for example, into the nostrils, although there are patients who find these seal-forming portions uncomfortable.

[0037] Another form of seal-forming structure can use an adhesive portion to achieve a seal. There are also patients who always find it inconvenient to attach or remove the adhesive portion to their face.

[0038] Disclosures of a range of patient interface seal-forming structure technologies are available 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 circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.) assigned to the Puritan-Bennett Corporation.

[0040] ResMed Limited manufactures the following products using nasal pillows: SWIFT® Nasal Pillow Mask, SWIFT® II Nasal Pillow Mask, SWIFT® LT Nasal Pillow Mask, SWIFT® FX Nasal Pillow Mask and MIRAGELIBERTY® Full Face Mask. The following patent applications assigned to ResMed Limited describe embodiments of nasal pillow masks: International Patent Application WO2004 / 073,778 (describing in particular the aspect of ResMed Limited's SWIFT® nasal pillow), U.S. Patent Application No. 2009 / 0044808 (describing in particular the aspect of ResMed Limited's SWIFT® LT nasal pillow); International Patent Applications WO2005 / 063,328 and WO2006 / 130,903 (describing in particular the aspect of ResMed Limited's MIRAGE LIBERTY® Full Face Mask); International Patent Application WO2009 / 052,560 (describing in particular the aspect of ResMed Limited's SWIFT® FX nasal pillow).

[0041] 2.2.3.1.2 Positioning and Stabilization The seal-forming structure of the patient interface used in positive pressure air therapy is subject to the corresponding forces of air pressure that interfere with the seal. Therefore, various techniques are used to position the seal-forming structure and maintain the seal against the appropriate part of the face.

[0042] In one technique, an adhesive part is used. See, for example, U.S. Patent Application Publication US2010 / 0000534. However, when an adhesive part is used, there may be discomfort.

[0043] In another technique, one or more straps and / or stabilization harnesses are used. In the case of a number of such harnesses, one or more of the following apply: poor fit, bulky, uncomfortable and difficult to handle.

[0044] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device The Respiratory Pressure Therapy (RPT) device can be used individually for the delivery of one or more of the above-mentioned treatments, or as part of a system, for example by operating the device to generate an air delivery flow to the interface to the airway. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Therefore, the RPT device can also function as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0045] Air pressure generators are known in a wide range of applications (for example, industrial scale ventilation systems). However, air pressure generators for medical use have specific requirements that cannot be satisfied by more general air pressure generators (for example, the reliability requirements, size requirements and weight requirements of medical devices). In addition, even a device designed for medical treatment may not be free from defects related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost and reliability.

[0046] An example of a special requirement for a specific RPT device is acoustic noise.

[0047] Table of noise output levels of conventional RPT devices (measured at 10 cmH2O in CPAP mode using the test method specified in ISO3744 for only 1 sample).

[0048] [Table 1]

[0049] As one known RPT device used for the treatment of sleep apnea, there is the S9 sleep therapy system (manufacturer: ResMed Limited). Another example of an RPT device is a ventilator. In the case of a ventilator (for example, the ResMed Stellar® series of adult and pediatric ventilators), it can provide assistance for invasive and non-invasive independent breathing for patients within a certain range for the treatment of multiple conditions (non-limiting examples include NMD, OHS, and COPD).

[0050] The ResMed Elisee® 150 ventilator and the ResMed VSIII® ventilator can provide assistance for invasive and non-invasive dependent breathing suitable for adult or pediatric patients for the treatment of multiple conditions. With these ventilators, volume ventilation mode and pressure ventilation mode using single or double limb circuits can be obtained. The RPT device typically includes a pressure generator (for example, an electric blower or a compressed gas reservoir) and is configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway with positive pressure. The outlet of the RPT device is connected to the patient interface as described above via an air circuit.

[0051] Numerous options can be presented to the device designers. Since design criteria often conflict with each other, certain design options may be far from convention or unavoidable. Furthermore, the comfort and effectiveness of a particular aspect can also be greatly affected by minor changes in one or more parameters.

[0052] 2.2.3.3 Air Circuit The air circuit is a conduit or tube constructed and arranged such that during use, an air flow moves between two components of the respiratory therapy system (for example, the RPT device and the patient interface). In some cases, there can be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation.

[0053] 2.2.3.4 Humidifier When the delivery of the air flow is carried out without humidification, it may lead to the drying of the airway. When a humidifier is used together with an RPT device and a patient interface, humidified gas is generated, so the drying of the nasal mucosa is minimized and the comfort of the patient airway is increased. In addition, in a cooler climate, generally adding warm air to the facial area around the patient interface increases comfort more than in the case of cold air.

[0054] Although a certain range of artificial humidifying devices and systems are known, they do not meet the special requirements of medical humidifiers.

[0055] Medical humidifiers are typically used to increase the humidity and / or temperature of the air flow relative to the ambient air when the patient is asleep or at rest (e.g., in a hospital), if necessary. A medical humidifier placed beside the pillow may be small. A medical humidifier may be configured to only humidify and / or heat the air flow delivered to the patient and not humidify and / or heat the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air taken into the patient's body by breathing, but in the case of these systems, since they also humidify and / or heat the entire room, it can be uncomfortable for the occupants. Furthermore, in the case of medical humidifiers, there may be more stringent safety constraints than industrial humidifiers.

[0056] Although many medical humidifiers are known, such medical humidifiers may suffer from one or more defects. That is, in the case of such medical humidifiers, some may have inappropriate humidification, while others may be difficult or inconvenient for patients to use.

[0057] 2.2.3.5 Data Management For clinical reasons, it may be necessary to obtain data to determine whether a patient for whom respiratory therapy has been prescribed is "compliant" (e.g., whether the patient is following one or more "compliance rules" with their RPT device). As an example of a compliance rule for CPAP therapy, for a patient to be considered compliant, the patient must use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days. To determine a patient's 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 the usage rate over a given period, and compare this to the compliance rule. If a healthcare provider determines that a patient has used their RPT device in accordance with the compliance rule, the healthcare provider may notify a third party that the patient is compliant.

[0058] In a patient's treatment, there may be other ways to benefit from communication of treatment data to a third party or an external system.

[0059] In the case of existing processes for communicating and managing such data, one or more of high cost, time consumption, and susceptibility to errors may occur.

[0060] 2.2.3.6 Mandibular repositioning A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from dentists or other providers that holds the mandible (lower jaw) in a forward position during sleep. The MRD is a removable device that is inserted into the mouth before the patient goes to sleep and removed after sleep. Therefore, the MRD is not designed for continuous wear applications. The MRD may be custom-made or manufactured in a standard form and includes an occlusal impression site designed to fit the patient's teeth. This mechanical protrusion from the mandible expands the space behind the tongue and applies tension to the pharyngeal wall, reducing airway collapse and reducing palatal vibration.

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

[0062] In such a design, the length of the connecting rod is selected such 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 vary the level of protrusion of the mandible. The dentist can determine the level of protrusion according to the mandible, and as a result, the length of the connecting rod is determined.

[0063] There are also MRDs configured to push the mandible forward relative to the maxilla, and there are also those designed to hold the mandible in a forward position, such as other MADs like the ResMed Narval CC (registered trademark) MRD. This device also reduces or minimizes dental side effects and side effects of the temporomandibular joint (TMJ) between the temple and the mandible. Therefore, this device is configured to minimize or avoid any movement of one or more of the teeth.

[0064] 2.2.3.7 Ventilation technology Some forms of treatment systems may include a ventilation portion for expelling the exhaled carbon dioxide. This ventilation portion may enable a gas flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings).

[0065] This ventilation portion may include an orifice, and during mask use, gas may flow through the orifice. In the case of a number of such ventilation portions, it may be noisy. In other cases, it may become blocked during use, resulting in insufficient extrusion. In the case of some ventilation portions, for example, due to noise or airflow concentration, it may interfere with the sleep of patient 1000 and co - sleeper 1100.

[0066] ResMed Limited has developed a number of improved mask ventilation technologies. See the following: 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; U.S. Patent Application Publication No. 2009 / 0044808.

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

[0068] [Table 2]

[0069] (*Measured at 10 cmH2O in CPAP mode using the test method specified in ISO3744 for only 1 sample)

[0070] List the sound pressure values of various subjects as follows

[0071] [Table 3]

[0072] 2.2.4 Screening, Diagnostic System, and Monitoring System

[0073] A polysomnogram (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and typically requires expert clinical staff for system application in many cases. In a PSG, typically 15 to 20 contact sensors are placed on the human body to record various body signals (e.g., electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyography (EMG)). For PSG of sleep disordered breathing, it was necessary to observe the patient in a specialized hospital for two nights. That is, the first night was for pure diagnosis, and the second night was necessary for titration of treatment parameters by a clinician. Therefore, PSG is costly and has low convenience. Screening / diagnosis / monitoring of sleep disordered breathing is particularly unsuitable at home.

[0074] Generally, screening and diagnosis are to identify a disease based on the signs and symptoms of the disease. Usually, screening gives a true / false result indicating whether the patient's SDB requires further investigation, while diagnosis often gives clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the course of a disease can be continued indefinitely. Some screening / diagnostic systems are only suitable for screening / diagnosis, while some can also be used for monitoring.

[0075] A clinical expert can appropriately perform screening, diagnosis, or monitoring of a patient based on visual observation of PSG signals. However, there are situations where there is no clinical expert or payment to a clinical expert is not possible. Opinions of clinical experts may differ regarding the patient's condition. Furthermore, some clinical experts may apply different criteria depending on the time.

Prior Art Documents

Patent Documents

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

[0077] 3 Brief Description of the Technology The present technology relates to the provision of medical devices used in the screening, diagnosis, monitoring, improvement, treatment or prevention of respiratory diseases, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0078] The first aspect of the present technology relates to a device used in the screening, diagnosis, monitoring, improvement, treatment or prevention of respiratory diseases.

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

[0080] One aspect of a specific form of the present technology is to provide a method and / or device for improving patient compliance with respect to respiratory therapy.

[0081] One form of the present technology is a patient interface for delivering an air flow in a sealed manner to an inlet of a patient's airway including at least the patient's nostril inlet at a continuous positive pressure with respect to the ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure during use throughout the patient's respiratory cycle during the patient's sleep so that sleep disordered breathing is improved, and the patient interface is: A plenum chamber that at least partially forms a cavity capable of being pressurized to a treatment pressure of at least 6 cmH2O above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's respiration, the plenum chamber and including a seal forming structure.

[0082] One form of the present technology includes a fabric seal forming structure together with a bridge portion between a first hole portion and a second hole portion, the bridge portion being crimped so as to be held with a higher tension than the remaining portion of the fabric film.

[0083] The seal forming structure according to another aspect of one form of the present technology has a fabric film connected to a flexible support structure in a relaxed state, and the bridge portion of the fabric film is crimped so as to be held with a higher tension than the remaining portion of the fabric film.

[0084] Another form of the present technology is a patient interface for delivering an air flow in a sealed manner to an inlet to a patient's airway including at least the patient's nostril inlet at a continuous positive pressure with respect to the ambient air pressure. This patient interface is configured to maintain a treatment pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure during use throughout the patient's respiratory cycle during the patient's sleep so as to improve sleep disordered breathing, the patient interface comprising: A plenum chamber that at least partially forms a cavity capable of being pressurized to a treatment pressure of at least 6 cmH2O above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's respiration, the plenum chamber and a seal forming structure, A fabric membrane constructed and arranged to form a pressure assist seal against an area of the patient's face surrounding the patient's airway inlet below the nasal bridge area of the patient's face, the fabric membrane having a portion, the seal-forming structure having a fabric membrane constructed and arranged to maintain the treatment pressure within the cavity throughout the patient's respiratory cycle during use. where: the fabric membrane is held in a relaxed state, the portion being held at a higher tension (e.g., selectively tensioned) than the remainder of the fabric membrane, and including a seal-forming structure.

[0085] In some embodiments, the fabric membrane has at least one or two holes formed such that airflow at the treatment pressure is delivered at least to the inlet of the patient's airway.

[0086] In some embodiments, the tensioning of the portion is performed via various techniques (e.g., crimping at one or more sites of the fabric membrane, such as the central and / or bridge sites). Instead of or in addition to the central or bridge sites, one or more other sites of the fabric membrane may be tensioned (e.g., crimped or other techniques). As an alternative or additional example of selective tensioning of one or more sites of the fabric membrane, the fabric membrane may be supported by a flexible support that may receive selective tensioning.

[0087] Another form of the technology is a patient interface for delivering airflow in a sealed manner to the inlet of a patient's airway, including at least the patient's nostril inlet, at a continuously positive pressure relative to ambient air pressure. This patient interface is configured to maintain a treatment pressure in the range of about 4 cmH2O to about 30 cmH2O higher than ambient air pressure during use throughout the patient's respiratory cycle during the patient's sleep, such that sleep disordered breathing is improved, the patient interface comprising: A plenum chamber that at least partially forms a cavity that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's respiration, a plenum chamber, A seal-forming structure, A fabric membrane constructed and arranged to form a pressure assist seal against an area of the patient's face surrounding an inlet to the patient's airway below the nasal bridge area of the patient's face, the fabric membrane having at least one hole such that an air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, the seal-forming structure having a fabric membrane constructed and arranged to maintain the treatment pressure within the cavity throughout the patient's respiratory cycle. Here: The fabric membrane includes a first portion held in a relaxed state and a second portion held in a tensioned state, the tensioned state of the second portion being configured such that the seal-forming structure includes a three-dimensional shape having a plurality of curvatures.

[0088] In some aspects, a) a region of the first portion is larger than a region of the second portion; b) the at least one hole includes a first hole and a second hole each configured to be disposed adjacent to one of the patient's nostrils in use, with a bridge portion disposed between the first hole and the second hole; c) the bridge portion is the second portion and is held in a tensioned state; d) the bridge portion is crimped to be held at a higher tension than the first portion of the fabric membrane; e) 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; f) the bridge portion is crimped using ultrasonic welding and / or an adhesive; and / or g) the ultrasonic welding and / or the adhesive is applied to the second member.

[0089] In some embodiments, a) the seal-forming structure further includes a flexible support structure for holding the fabric membrane in a three-dimensional shape; b) the seal-forming structure includes a single wall portion, and the ends of the flexible support structure contact the fabric membrane; c) the seal-forming structure includes a pair of wall portions, the flexible support structure includes a free end, the fabric membrane is connected to the flexible support structure provided distally with respect to the free end, and by arranging the free end spaced apart from the fabric membrane, the fabric membrane is arranged radially outside the free end; d) the flexible support structure is connected to the fabric membrane by injection molding; and / or e) the bridge site becomes a positioning spigot after being crimped.

[0090] In some embodiments, a) the fabric membrane includes a first curvature around a first axis intersecting a first hole and a second hole, and before being crimped, the bridge site includes a bridge curvature in a direction opposite to the rest of the fabric membrane around the first axis; b) a second axis extends along the bridge site transverse to the first axis, and the fabric membrane includes a secondary curvature around the second axis; c) the secondary 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 secondary curvature is configured to contact the subnasal point of the patient during use; e) a third axis extends transverse to the second axis and is skewed with respect to the first axis, and the fabric membrane includes a tertiary curvature around the third axis; f) the tertiary curvature is configured to contact the upper lip of the patient during use; g) a fourth axis extends transverse to the second axis to the third axis and is parallel to the first axis, and the fabric membrane includes a quaternary curvature around the fourth axis; h) the quaternary curvature includes a variable radius of curvature; and / or i) the quaternary curvature extends into the primary curvature near the edge of the fabric membrane.

[0091] In some embodiments, a) a portion of the first aperture 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 fabric membrane moves to the second position due to an external force; c) a portion of the first aperture extends into the plenum chamber at the second position; d) the first aperture includes a generally drip shape at the second position; e) at the second position, the first aperture is configured to contact the periphery of an inlet to one of the patient's nostrils adjacent to the nostril rim; and / or f) a portion of the second aperture distal to the bridge portion is movable between a first position and a second position.

[0092] In some embodiments, a) the fabric membrane includes a fabric layer and a silicone layer coupled to the fabric layer, the silicone layer being impermeable; b) the thickness of the silicone layer is approximately 0.5 mm; c) the silicone layer is disposed within a cavity and configured not to contact the patient's skin during use; and / or d) the silicone layer has low durometer properties, and the fabric membrane has a high stretch ability when coupled to a flexible support structure.

[0093] In some embodiments, a) the length of the bridge portion is directly related to the size of the first aperture and the size of the second aperture; b) the fabric membrane is configured to be curved about at least two non-parallel axes due to the tension state of the second portion, thereby forming a three-dimensional shape; c) the fabric membrane includes a multi-layer fabric material and a silicone layer coupled to the multi-layer fabric material; d) the multi-layer fabric material includes a first layer, a second layer, and a third layer, the silicone layer contacts only the first layer, and the third layer is configured to contact the patient's face during 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 fabric 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 fabric membrane during use.

[0094] Another form of this technology is a patient interface for delivering an air flow in a sealed manner to an inlet to a patient's airway, including at least the patient's nostril inlets, at a continuously positive pressure relative to the ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure during use throughout the patient's breathing cycle during the patient's sleep, so as to improve sleep disordered breathing, and the patient interface comprises: A plenum chamber that at least partially forms a cavity that can be pressurized to a therapeutic pressure of at least 6 cmH2O above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive the air flow at the therapeutic pressure for the patient's breathing, the plenum chamber, and A seal-forming structure, A fabric membrane constructed and arranged to form a pressure assist seal against an area of the patient's face that surrounds an inlet to the patient's airway below the nasal bridge area of the patient's face, the fabric membrane having a first hole and a second hole, a bridge portion being disposed between the first hole and the second hole, the first hole and the second hole being formed therein such that the air flow at the therapeutic pressure is delivered at least to the inlet to the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's breathing cycle during use, the fabric membrane, and A flexible support structure for holding the fabric membrane in a pre-defined shape, having wherein: The fabric membrane is connected to the flexible support structure in a relaxed state, The bridge portion is crimped so as to be held at a higher tension than the rest of the fabric membrane, the seal-forming structure.

[0095] Another form of the present technology is a patient interface for delivering an air flow continuously at a positive pressure relative to the ambient air pressure to the entrance of the patient's nostrils and to the entrance of the patient's mouth in a sealed manner. This patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure during use throughout the patient's breathing cycle during the patient's sleep, so that sleep disordered breathing is improved, and the patient interface comprises: A plenum chamber that at least partially forms a cavity that can be pressurized to a therapeutic pressure of at least 6 cmH2O above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive the air flow at the therapeutic pressure for the patient's breathing, a plenum chamber, and A seal forming structure including a fabric membrane constructed and arranged to form a pressure assist seal against the patient's face region surrounding the entrance to the patient's nostrils and the entrance to the patient's mouth, the seal forming structure comprising: A nasal portion configured to at least partially surround the entrance to the patient's nostrils, and A mouth portion configured to at least partially surround the entrance to the patient's mouth, including The fabric membrane has at least one hole such that the air flow at the therapeutic pressure is delivered to at least the entrance to the patient's nostrils and / or the entrance to the patient's mouth, and the seal forming structure is constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's breathing cycle during use, having a fabric membrane, The fabric membrane includes a first portion held in a relaxed state and a second portion held in a tense state, and the tense state of the second portion is configured such that the seal forming structure includes a three-dimensional shape having a plurality of curvatures.

[0096] In some embodiments, a) at least one aperture includes a nostril opening configured to be disposed adjacent to a patient's nostril and an oral site configured to be disposed adjacent to a patient's mouth in use; b) the bridge portion extends across the nostril opening, dividing the nostril opening into a first aperture and a second aperture, the first aperture and the second aperture each being configured to be disposed adjacent to one of the patient's nostrils in use; c) the bridge portion is a second portion and is held in a tensioned state; and / or d) the bridge portion is crimped using ultrasonic welding and / or an adhesive.

[0097] In some embodiments, a) the first portion at least partially includes the oral site; b) the first portion includes members of the oral site and the nasal site; c) the seal-forming structure further includes a flexible support structure for holding the fabric membrane in a three-dimensional shape; d) the flexible support structure includes at least one support rib that engages the oral site within the cavity of the plenum chamber; e) the flexible support structure further includes secondary ribs disposed within the cavity, the support rib extending between the secondary rib and the oral site; f) the fabric membrane of the seal-forming structure is curved about at least two non-parallel axes due to the tensioned state of the second portion, thereby forming a three-dimensional shape; g) the oral site is curved about at least two non-parallel axes; and / or h) the fabric membrane includes a fabric layer and a silicone layer coupled to the fabric layer, the silicone layer being impermeable. In some embodiments, a) the seal-forming structure is constructed of a fabric membrane, the fabric 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 portion constructed of a material other than the fabric membrane, the flexible support portion 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 at least partially disposed between the ends of the first sub-member; e) at least one aperture includes a nostril opening configured to be disposed adjacent to a patient's nostril and a mouth portion configured to be disposed adjacent to a patient's mouth, the perimeter of the mouth portion being completely formed by the first sub-member; the perimeter of the nostril opening being completely formed by the second sub-member; f) at least one aperture includes a nostril opening configured to be disposed adjacent to a patient's nostril and a mouth portion configured to be disposed adjacent to a patient's mouth, the perimeter of the nostril opening being formed by the second sub-member; the perimeter of the mouth portion being 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 portion and includes an annular shape; and / or h) the second sub-member forms at least a portion of the mouth portion and includes a U-shaped configuration.

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

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

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

[0101] In some embodiments, the length of the bridge portion 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 is substantially flat and configured to contact the patient in use, and the second member extends into the plenum chamber.

[0103] In some embodiments, ultrasonic welding and / or an adhesive is added to the second member.

[0104] In some embodiments, the seal-forming structure includes a single wall portion, and the end of the flexible support structure contacts the fabric membrane.

[0105] In some embodiments, the seal-forming structure includes a pair of wall portions, the flexible support structure includes a free end, the fabric membrane is connected to the flexible support structure provided distally with respect to the free end, and by arranging the free end spaced apart from the fabric membrane, the fabric membrane is arranged radially outside the free end.

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

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

[0108] In some embodiments, the fabric membrane includes a fabric layer and a silicone layer connected to the fabric layer, and the silicone layer has impermeability.

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

[0110] In some embodiments, the fabric membrane includes a multi-layer fabric material and a silicone layer connected to the multi-layer fabric material.

[0111] In some embodiments, the multilayer fabric material includes a first layer, a second layer, and a third layer, the silicone layer contacts only the first layer, and the third layer is configured to contact the patient's face during use.

[0112] In some embodiments, the first layer and the third layer 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 fabric membrane includes high stretch capabilities when connected to a flexible support structure.

[0115] In some embodiments, the thickness of the fabric membrane is approximately 0.35 mm to approximately 0.45 mm.

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

[0117] In some embodiments, a second axis extends along the bridge portion transverse to the first axis, and the fabric membrane includes a secondary curvature around the second axis.

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

[0119] In some embodiments, the secondary curvature is configured to contact the subnasale of the patient during use.

[0120] In some embodiments, a third axis extends transverse to the second axis and is skewed with respect to the first axis, and the fabric membrane includes a tertiary curvature around the third axis.

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

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

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

[0124] In some embodiments, the fourth curvature extends into a first curvature near an edge of the fabric membrane.

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

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

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

[0128] In some embodiments, the first aperture includes a substantially drooping shape at the second position.

[0129] In some embodiments, at the second position, the first aperture is configured to contact the periphery of an entrance to one of the patient's nostrils near the nostril edge.

[0130] In some embodiments, a portion of the second aperture distal to the bridge site 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 fabric membrane during use.

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

[0133] In another aspect of the present invention, it is a patient interface for delivering an air flow in a sealed manner to an inlet to a patient's airway including at least the patient's nostril inlets at a continuous positive pressure relative to the ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than the ambient air pressure during use throughout the patient's respiratory cycle during the patient's sleep so as to improve sleep disordered breathing, and the patient interface comprises: A plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the therapeutic pressure for the patient's respiration, the plenum chamber; A fabric membrane constructed and arranged to form a pressure assist seal against an area of the patient's face surrounding an inlet to the patient's airway below the nasal bridge region of the patient's face, the fabric membrane having a first hole and a second hole, a bridge portion being disposed between the first hole and the second hole, the first hole and the second hole being formed therein such that an air flow at the therapeutic pressure is delivered at least to the inlet to the patient's nostrils, the seal forming structure including the fabric membrane constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use; wherein: The seal-forming structure includes a flexible support structure for holding the fabric film in a pre-defined curved shape, the fabric film including a first curvature around a first axis and a second curvature around a second axis generally transverse to the first axis, the first axis being configured to generally transverse the sagittal plane of the patient's head (such that the first curvature includes a vertex in the posterior direction), whereby the first curvature extends around the nasolabial groove of the patient's nose, and the second axis being configured to be generally parallel to the sagittal plane (such that the second curvature includes a vertex in the downward direction), whereby the second curvature forms a saddle region and has a generally positive curvature relative to the patient's upper lip in use, The bridge portion has a third curvature opposite to the first curvature, and the third curvature of the bridge portion limits the occurrence of wrinkles along the surface of the fabric film. The fabric film is connected to the flexible support structure in a relaxed state. In use, the fabric film is configured to be pressed against the patient's face so that the patient's nose is not received into the cavity. The fabric film is attached to the flexible support structure along the outer periphery of the fabric film, thereby extending radially inwardly beyond the support structure.

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

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

[0136] In some embodiments, the fabric film is substantially impermeable to air.

[0137] In some embodiments, the fabric film includes a fabric layer and a silicone layer connected to the fabric layer, the silicone layer being 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 configured to not contact the patient's skin during use.

[0140] In some embodiments, the silicone layer has low durometer properties and the fabric layer includes high stretch capabilities when connected to the support structure.

[0141] In some embodiments, the thickness of the fabric membrane is from approximately 0.35 mm to approximately 0.45 mm.

[0142] In some embodiments, the seal-forming structure includes a single wall portion and the end of the flexible support structure contacts the fabric membrane.

[0143] In some embodiments, the seal-forming includes a pair of wall portions, the flexible support structure includes a free end, the fabric membrane is connected to the flexible support structure provided distally to the free end, and by disposing the free end spaced apart from the fabric membrane, the fabric membrane is disposed radially outside the free end.

[0144] In some embodiments, the first aperture includes a first arcuate portion, the first arcuate portion generally has a first curvature, and the first arcuate portion is configured to be disposed within the patient's first nostril.

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

[0146] In some embodiments, the second aperture includes a second arcuate portion, the second arcuate portion generally has a first curvature, and the second arcuate portion is configured to be disposed within the patient's second nostril.

[0147] In some embodiments, the first aperture includes a generally circular shape and is configured to include a generally drooping shape after contacting the patient's face.

[0148] In some embodiments, the fabric membrane is configured to contact only the patient's upper lip, subnasal point, and nasal tip point during use.

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

[0150] In some embodiments, the fabric membrane includes a fourth curvature about a fourth axis, the fourth curvature being a saddle-shaped region generally having a positive curvature with respect to the patient's subnasal point during use, and the fourth axis generally transverse to the first and second axes.

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

[0152] In another aspect of the technology, a patient interface for delivering an airflow in a sealed manner to an inlet to a patient's airway, including at least the patient's nostril inlets, at a continuous positive pressure relative to ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O higher than ambient air pressure during use throughout the patient's respiratory cycle during the patient's sleep, so as to improve sleep disordered breathing, and the patient interface includes: A plenum chamber at least partially forming a cavity pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an airflow at the therapeutic pressure for the patient's breathing, the plenum chamber, and A fabric membrane constructed and arranged to form a pressure assist seal against an area of the patient's face surrounding the patient's airway inlet below the nasal bridge area of the patient's face, the fabric membrane having a first hole and a second hole, with a bridge portion disposed between the first hole and the second hole, the first hole and the second hole being formed therein such that airflow at the treatment pressure is delivered at least to the inlet of the patient's nostrils, the seal-forming structure including the fabric membrane constructed and arranged to maintain the treatment pressure within the cavity throughout the patient's respiratory cycle. where: The seal-forming structure includes a flexible support structure for holding the fabric membrane in a pre-defined curved shape, the fabric membrane including a first curvature about a first axis and a second curvature about a second axis generally transverse to the first axis, the first axis configured to include an apex in the rearward direction in the first curvature by generally traversing the sagittal plane of the patient's head, whereby the first curvature is generally a negative dome curvature with respect to the patient's upper lip in use, and the second axis configured to include an apex in the downward direction in the second curvature by being generally parallel to the sagittal plane, whereby the second curvature is generally a saddle-shaped region and is a positive curvature with respect to the patient's nasal tip point in use. The bridge portion has a third curvature opposite to the first curvature, and the third curvature of the bridge portion limits the occurrence of wrinkles along the surface of the fabric membrane. The fabric membrane is connected to the flexible support structure in a relaxed state. In use, the fabric membrane is configured to be pressed against the patient's face so that the patient's nose is not received into the cavity. The fabric membrane extends radially inwardly beyond the support structure by being attached to the flexible support structure along the outer periphery of the fabric membrane.

[0153] In some embodiments, the fabric membrane includes a fourth curvature around a fourth axis configured to have a rearward apex by being generally parallel to a first axis, such that the fourth curvature extends around the nasolabial groove of the patient's nose.

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

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

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

[0157] In some embodiments, the fabric membrane includes a fabric layer and a silicone layer coupled to the fabric layer, the silicone layer being 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 configured not to contact the patient's skin during use.

[0160] In some embodiments, the silicone layer has low durometer properties and the fabric layer includes high stretchability when coupled to the support structure.

[0161] In some embodiments, the thickness of the fabric membrane is approximately 0.35 mm to approximately 0.45 mm.

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

[0163] In some embodiments, the seal formation includes a pair of wall portions, the flexible support structure includes a free end, the fabric membrane is connected to the flexible support structure provided distally to the free end, and by disposing the free end at a distance from the fabric membrane, the fabric membrane is disposed radially outside the free end.

[0164] In some embodiments, the first hole includes a first arcuate portion, the first arcuate portion generally has a first curvature, and the first arcuate portion is configured to be disposed within a first nostril of a patient.

[0165] In another aspect of the present technology, the seal formation structure is: A fabric membrane constructed and arranged to form a pressure assist seal against an area of the patient's face surrounding an inlet to the patient's airway below the nasal bridge area of the patient's face, the fabric membrane having a first hole and a second hole, a bridge portion being disposed between the first hole and the second hole, the first hole and the second hole being formed therein such that airflow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, the seal formation structure being constructed and arranged to maintain the treatment pressure within the cavity throughout the patient's respiratory cycle during use. A flexible support structure for holding the fabric membrane in a pre-defined shape. Here: The fabric membrane is connected to the flexible support structure in a relaxed state. The bridge portion is crimped so as to be held at a higher tension than the rest of the fabric membrane.

[0166] Another form of the present technology is a patient interface for delivering airflow in a sealed manner to an inlet to a patient's airway including at least the patient's nostril inlet at a continuous positive pressure relative to ambient air pressure. This patient interface is configured to maintain a treatment pressure in the range of about 4 cmH2O to about 30 cmH2O higher than ambient air pressure during use throughout the patient's respiratory cycle during the patient's sleep, such that sleep disordered breathing is improved. The patient interface includes: A plenum chamber that at least partially forms a cavity capable of being pressurized to a treatment pressure of at least 6 cmH2O exceeding the ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's respiration, a plenum chamber, A seal forming structure, A fabric membrane constructed and arranged to form a pressure assist seal against an area of the patient's face surrounding an inlet to the patient's airway below the nasal bridge area of the patient's face, the fabric membrane having a portion, the seal forming structure having a fabric membrane constructed and arranged to maintain the treatment pressure within the cavity throughout the patient's respiratory cycle during use, The fabric membrane is held in a tensioned state, including a seal forming structure.

[0167] One form of the present technology includes a fabric seal forming structure with a bridge portion between a first hole and a second hole, and the entire fabric seal forming structure is held in a tensioned state.

[0168] Another aspect of the seal forming structure of one form of the present technology has a fabric membrane connected to a flexible support structure in a tensioned state, and the bridge portion of the fabric membrane becomes substantially flat due to the tension.

[0169] Another aspect of the seal forming structure of one form of the present technology has a fabric membrane connected to a flexible support structure in a tensioned state prior to use, and the fabric membrane has a substantially flat surface in at least one direction in the tensioned state prior to use.

[0170] In some aspects, the application of tension to the fabric membrane is performed via various techniques (e.g., non-use of crimps at one or more portions of the fabric membrane (e.g., the central portion and / or the bridge portion)). The central portion and / or the bridge portion can be in a tensioned state and substantially flat prior to use by the patient. The fabric membrane can be supported by a flexible support portion and can be stretched or otherwise tensioned prior to connection to the flexible support portion.

[0171] Another aspect of one form of the present technology is a patient interface molded or otherwise constructed with a peripheral shape that is complementary to the intended wearer's shape.

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

[0173] One aspect of a particular form of the present technology is an easy-to-use medical device for, for example, people who have not received medical training, people who are not very dexterous or lack insight, or people with limited experience using this type of medical device.

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

[0176] The described methods, systems, devices, and apparatuses can be embodied to improve functions in a processor (e.g., the functions of a processor of a special-purpose computer, a respiratory monitor, and / or a respiratory therapy device). Further, the described methods, systems, devices, and apparatuses enable improvements in the technical field of automatic management, monitoring, and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0177] Of course, some of the above aspects can form sub-aspects of the present technology. Also, various combinations of various ones of the sub-aspects and / or aspects can be made, which can also constitute further aspects or sub-aspects of the present technology.

[0178] Other features of the technology will become apparent in light of the information contained in the following detailed description, the summary, the drawings, and the claims.

Brief Description of the Drawings

[0179] 4 Brief Description of the Drawings The technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals refer to the following like elements: 4.1 Respiratory Therapy System

Figure 1A

Figure 1B

Figure 1C

Figure 2A

Figure 2B

Figure 2C

Figure 2D

Figure 2E

Figure 2F

Figure 2G

Figure 2H

Figure 2I

Figure 2J

Figure 2K

Figure 2L

Figure 3A

Figure 3B

Figure 3C

Figure 3D

Figure 3E

Figure 3F

Figure 3G

Figure 3H

Figure 3I

Figure 3J

Figure 3K

Figure 3L

Figure 3M

Figure 3N

Figure 3O

Figure 3P

Figure 3Q

Figure 3R

Figure 3S

Figure 3T

Figure 3U

Figure 3V

Figure 3W

Figure 3X

Figure 4A

Figure 4B

[0180]

Figure 5

Figure 6

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Figure 14

Figure 15

Figure 16

Figure 17

Figure 18

Figure 19

Figure 20

Figure 21

Figure 22

Figure 23

Figure 24

Figure 25

Figure 26

Figure 27

Figure 28

Figure 29

Figure 30

Figure 31

Figure 32

Figure 33

Figure 33-1

Figure 33-2

Figure 33-3

Figure 33-4

Figure 33-5

Figure 33-6

Figure 33-7

Figure 33-8

Figure 33-9

Figure 33-10

Figure 33-11

Figure 34

Figure 35

Figure 36

Figure 37

Figure 38

Figure 39

Figure 40

Figure 40-1

Figure 41

Figure 42

Figure 43

Figure 44

Figure 45

Figure 46

Figure 47

Figure 48

Figure 49

Figure 50

Figure 51

Figure 52

Figure 53

Figure 54

Figure 55

Figure 56

Figure 57

Figure 58

Figure 59

Figure 60

Figure 61

[0181] 5 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY Before describing the technology in more detail, it should be understood that the technology is not limited to the specific examples that may be described herein. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific examples described herein and are not limiting.

[0182] The following description is provided in relation to various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. Additionally, any single feature or combination of features in any of these examples may constitute a further example.

[0183] 5.1 Treatment Method In one form, the technology includes a method of treating a respiratory disease. The method includes applying positive pressure to the inlet of the airway of patient 1000.

[0184] In certain examples of the technology, an air supply at positive pressure is provided to the nasal passages of the patient via one or both of the nostrils.

[0185] In certain examples of the technology, mouth breathing is restricted, limited, or impeded.

[0186] 5.2 Respiratory Therapy System In one form, the present technology includes a respiratory therapy system for the treatment of respiratory diseases. The respiratory therapy system may include an RPT device 4000 that supplies an air flow 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 according to one aspect of the present technology includes the following functional modalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation section 3400, a form of connection port 3600 for connection to the air circuit 4170, and a forehead support 3700. In some forms, the functional modalities may be provided by one or more physical components. In some forms, one physical component may provide one or more functional modalities. In use, the seal-forming structure 3100 is arranged to surround the inlet(s) to the patient's airway 1000 so as to maintain a positive pressure at the inlet to the patient's airway. Thus, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy.

[0188] If the patient interface cannot comfortably deliver the lowest level of positive pressure to the airway, the patient interface may be inappropriate for respiratory pressure therapy.

[0189] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to the ambient.

[0190] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to the ambient.

[0191] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to the ambient. 5.3.1 Seal-Forming Structure

[0192] In one form of the present technology, the seal formation structure 3100 can provide a target seal formation region and further provide a cushioning function. The target seal formation region is a region where sealing can occur in the seal formation structure 3100. The region where sealing actually occurs (i.e., the actual sealing surface) can vary daily by the patient in a given treatment session depending on a range of factors (e.g., the placement position of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face).

[0193] In one form, the target seal formation region is disposed on the outer surface of the seal formation structure 3100.

[0194] In a particular form of the present technology, the seal formation structure 3100 is composed of a biocompatible material (e.g., silicone rubber).

[0195] The seal formation structure 3100 according to the present technology can be composed of a soft, flexible and elastic material (e.g., silicone).

[0196] In some forms, such as those shown in FIGS. 6 to 39, the seal formation structures 3100, 6100 and 9100 have a sealing portion including a fabric material. The fabric material can cover all or part of the seal formation structures 3100, 6100 and 9100. In some forms, the fabric can include a material formed by a fiber network and can be adapted to be impermeable to air. For example, the fabric can have an air-impermeable film on at least one of its surfaces, thereby forming a fabric film or a fabric sealing portion.

[0197] In some forms, the fabric membrane can be constructed to elastically stretch in at least one dimension. For example, if the fabric membrane is constructed from a fiber web, the fabric membrane may be able to stretch in the longitudinal warp direction and / or the transverse weft direction across the fabric membrane. In some forms, the fabric membrane is constructed to elastically stretch to a range beyond what can be achieved by conventional silicone seal forming structures.

[0198] In some forms, the fabric membrane is constructed to be substantially inelastic in at least one dimension. For example, if the fabric membrane is constructed from a fabric material, the fabric membrane may be able to substantially withstand elongation in one or both of the longitudinal warp direction or the transverse weft direction across the fabric membrane.

[0199] The fabric membrane can include a single layer or multiple layers. In forms where multiple layers are used, the individual layers can be formed using the same material or a variety of different materials each having unique material properties.

[0200] In some forms, the fabric membrane can 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 fabric membrane can include an air-impermeable material 10131 (e.g., a silicone layer) formed on one side of the fabric material 10133. The air-impermeable material 10131 can be laminated onto the fabric material 10133 in some forms. In some forms, the air-impermeable material 10131 and the fabric material 10133 can be selected such that the resulting fabric membrane 10135 can exhibit a predetermined overall elasticity or elastic resistance as needed. For example, the addition of the air-impermeable material 10131 (or membrane layer) can provide elasticity (or stretchability) to the fabric material 10133, thereby increasing the stretchability of the resulting fabric membrane 10135. The air-impermeable material 10131 can also have low durometer properties so as not to interfere with the elasticity of the fabric material 10133. In other words, since the fabric membrane 10135 has substantially the same elasticity as the sole elasticity of the fabric material 10133, the elasticity (or stretchability) of the fabric material 10133 does not substantially decrease even when the air-impermeable material 10131 is added.

[0201] The air-impermeable material 10131 can have a thickness that is less than the thickness of the fabric material 10133. Thus, since the thickness of the air-impermeable material 10131 is relatively small, the weight of the fabric material 10133 is not significantly increased either, which can help maintain a substantially lightweight fabric membrane 10135. In the case of a patient interface comprising the fabric membrane 10135 including the air-impermeable material 10131, it may no longer feel significantly heavier than a patient interface that includes only the fabric material 10133.

[0202] In some examples, the thickness of the fabric membrane 10135 is approximately 0.25 mm to approximately 0.55 mm. In some examples, the thickness of the fabric membrane 10135 is approximately 0.30 mm to approximately 0.50 mm. In some examples, the thickness of the fabric membrane 10135 is approximately 0.35 mm to approximately 0.45 mm. In some examples, the thickness of the fabric 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 forms, the fabric material 10133 can be formed as a multilayer fabric. In other words, by combining a plurality of fabric pieces together, the overall fabric material 10133 can be formed. As shown in FIG. 40-1, the fabric material 10133 can be constructed from three layers (however, any number of layers can be used). The second layer 10133b of the fabric material 10133 can 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 layer and the outer layer) are constructed from nylon. However, other materials can be used without departing from the scope and intent of these forms. Further, the first layer 10133a and the third layer 10133c can be formed from different materials (i.e., not the same material).

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

[0206] In some forms, a laminated structure can provide a sponge-like feel in the fabric material 10133. In other words, the fabric material 10133 can be compliant and deform when contacting the patient's face. Specifically, the thickness of the fabric material 10133 can become thinner when a force is applied and return to its original shape when the force is removed. Thus, the fabric material 10133 can function like a sponge because it can at least partially absorb the applied force. Specifically, the spandex layer 10133b of the fabric material 10133 (e.g., elasticity) can enable a sponge-like feel. The sponge-like feel of the fabric material 10133 can assist in improving comfort for the patient's skin (e.g., because the fabric material 10133 can conform to various shaped faces). Also, the sponge-like feel of the fabric material 10133 can assist in improving the seal against the patient's face. In particular, the fabric material 10133 can deform to fit the gaps on the patient's face (e.g., the area between the nose wing and the nasolabial groove) due to the applied force (e.g., via the positioning and stabilization structure 3300), without wrinkles and without creating locations where air leakage can occur. This can assist in establishing a seal between the patient's skin and the fabric membrane 10135 without the need to keep the fabric membrane 10135 in contact with the same location (as a result, for example, wearing the seal forming structure 3100 can become easier). Also, it can be possible to move and / or displace the seal forming structures 3100, 6100, and 9100 (without wrinkle formation) when worn. This is because the sponge-like properties assist in maintaining the necessary contact with the patient's skin.

[0207] In some forms, to form the impermeable fabric membrane 10135, the fabric material 10133 is coated (e.g., laminated) with an air-impermeable layer 10131 (e.g., liquid silicone rubber). In the illustrated example, the air-impermeable layer 10131 is added to a single side of the fabric material 10133. In other words, the air-impermeable layer 10131 can be added to the first layer 10133a, while it cannot be added to the second layer 10133b or the third layer 10133c. When the fabric membrane 10135 is constructed as the seal-forming structure 3100, 6100, 9100, the first layer 10133a is configured to be disposed within the cavities 3101, 6001, 9001, so that the third layer 10133c is configured to face and contact the patient.

[0208] In one form, the fabric material 10133 is formed from a fine knitted fabric. Specifically, the first layer 10133a and the third layer 10133c are constructed by fine knitting. This can be a fabric of less than approximately 100 denier. This can be a fabric of less than approximately 50 denier. This can be a fabric of less than approximately 20 denier. The fine knitting of the fabric (especially that in the third layer 10133c) provides a smooth feel to the patient's skin and can promote patient adaptability (e.g., by improving comfort). Also, the fine knitting of the fabric can avoid the leaching of the air-impermeable layer 10131 through the fabric layer 10133 (e.g., during the manufacturing process). For example, the fine knitting of the first layer 10133a can limit all leaching or allow some leaching, but can also substantially limit leaching into the other layers 10133b and 10133c. In other words, the first layer 10133a functions as a barrier and substantially limits the air-impermeable layer 10131 from contacting and / or coating the second layer 10133b or the third layer 10133c. Since the first layer 10133a does not contact the patient, some leaching can be tolerated. Because the relative rigidity of the first layer 10133a is not as important for patient comfort as the third layer 10133c (which directly contacts the patient's skin). Thus, the spandex elasticity may be lost due to contact with the air-impermeable layer 10131. Further, the smooth texture of the third layer 10133c may be lost due to penetration into the air-impermeable layer 10131. Since the coating of the air-impermeable material 10131 (i.e., making the fabric film 10135 impermeable) is required only on one side of the fabric material 10133, an impermeable film 10135 can be constructed that does not substantially limit patient comfort.

[0209] In some embodiments, when the fabric material 10133 is coated with an air-impermeable material, the material properties of the fabric film 10133 are not substantially affected. For example, since the air-impermeable material 10131 cannot substantially reach the second layer 10133b, the elasticity of the spandex forming the second layer 10133b does not substantially decrease. As a result, the entire fabric film 10135 can continuously stretch due to the applied force. Further, if there is penetration into the air-impermeable layer 10131, the drapability of the third layer 10133c may be lost, and as a result, the third layer 10133c may become hard. In that case, the ability of the third layer 10133c to form a seal against the patient's face may decrease. Therefore, in addition to comfort, by blocking the air-impermeable layer 10131 from the third layer 10133c, the third layer 10133c is substantially maintained in a relaxed state, enabling a seal against the patient's face.

[0210] In some embodiments, the thickness T of the air-impermeable layer 10131 I1 does not exceed approximately 500 microns. In some embodiments, the thickness T of the air-impermeable layer 10131 I1 is approximately 4 microns to approximately 400 microns. In some embodiments, the thickness T of the air-impermeable layer 10131 I1 is approximately 8 microns to approximately 300 microns. In some embodiments, the thickness T of the air-impermeable layer 10131 I1 is approximately 12 microns to approximately 200 microns. In some embodiments, the thickness T of the air-impermeable layer 10131 I1 is approximately 16 microns to approximately 100 microns. In some embodiments, the thickness T of the air-impermeable layer 10131 I1 is approximately 20 microns to approximately 70 microns. In some embodiments, the thickness T of the air-impermeable layer 10131 I1 is approximately 40 microns.

[0211] In some embodiments, the actual thickness T of the air-impermeable layer 10131 in the fabric film 10135 I2is the thickness T of the air-impermeable layer 10131 before being coated onto the textile material 10133 I1 may be less (but not always) than. In other words, when the air-impermeable material 10131 penetrates into the first layer 10133a, the thickness T of the air-impermeable layer 10131 I1 partially overlaps with the thickness of the first layer 10133a, so the thickness T measured from the outer surface of the first layer 10133a (i.e., the surface facing the cavity) to the exposed surface of the air-impermeable layer 10131 (i.e., the surface facing the cavity) I2 is the overall thickness T of the air-impermeable layer 10131 I1 is less than.

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

[0213] As a result of the separation between the air-impermeable layer 10131 and the second 10133b (i.e., the intermediate layer) and the third layer 10133c (i.e., the patient contact layer) being maintained, various benefits are brought to the fabric film 10135. As described above, for the achievement of the impermeable film 10135, the material properties of the fabric material 10133 are not substantially sacrificed. Specifically, the third layer 10133 maintains a smooth surface texture for patient comfort, and the second layer 10133b does not substantially lose its elasticity. Since the first layer 10133a, the third layer 10133c, and the air-impermeable layer 10131 can all have elasticity, they can stretch together with the second layer 10133b. Specifically, since the air-impermeable layer can have a low durometer (e.g., approximately 20 to approximately 40), it can have higher stretchability compared to the higher durometer air-impermeable layer 10131 (e.g., does not substantially limit the stretching ability of the fabric material 10133).

[0214] In other examples, the fabric film 10135 is entirely constructed from the fabric material 10133. The fabric material 10133 may include air-impermeable yarns that impart impermeability onto the fabric film 10135. Since an additional layer of the air-impermeable material 10131 may not be required, it may be possible to make the fabric film 10135 thinner (i.e., just the thickness of the fabric material). Since the air-impermeable yarns can have the same elasticity as non-air-impermeable yarns, the fabric film 10135 including the air-impermeable yarns does not lose its stretchability.

[0215] In some forms, the fabric membrane 10135 can exhibit a low spring constant (i.e., high compliance) in both the warp and weft directions. In such forms, in contrast to conventional designs where distortion of the patient's face 1300 can occur due to a fixed cushion (for the formation of an effective seal), the fabric material 10133 and / or the resulting fabric membrane 10135 can have a material spring constant and spring length such that the fabric membrane 10135 is more compliant than the patient's skin with which it engages. This can improve mask comfort and reduce the formation of areas where local pressure "hot spots" or irritation due to contact with the seal formation structures 3100, 6100, 9100 may occur, which is advantageous.

[0216] In some forms, the surface of the fabric material 10133 that contacts the patient's face 1300 can have low friction characteristics. This can improve the surface texture comfort of the fabric membrane 10135 and reduce friction against the patient's face 1300, which is advantageous. The surface of the fabric material 10133 (e.g., herringbone) can have a first coefficient of friction in a first direction. The first coefficient of friction is different (e.g., higher or lower) from the coefficient of friction in a second direction. In contrast, in the case of a higher friction fabric, it can cause snagging or friction of the fabric membrane 10135 in the contact area of the patient's face during use. Such friction or snagging can cause distortion or deformation of the fabric membrane 10135, which in turn can lead to a decrease in seal effectiveness and the possibility of unwanted air leakage from the device.

[0217] In certain forms of the present technology, a system is provided that includes more than one seal formation structure 3100. Each seal formation structure 3100 is configured to accommodate different size and / or shape ranges. For example, the system can include one form of the seal formation structure 3100 suitable for a large-sized head rather than a small-sized head and another suitable for a small-sized head rather than a large-sized head.

[0218] Although in this specification a particular example illustration or a feature of a particular example illustration (e.g., the seal formation structure 3100) may be referred to (e.g., using reference numerals), it should be noted that such discussion may also apply to other examples and / or features (e.g., the seal formation structures 6100, 9100).

[0219] 5.3.1.1 Sealing mechanism In one form, the seal formation structure includes a sealing flange that uses a pressure assist sealing mechanism. In use, the sealing flange can easily respond to the system positive pressure within the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface. The pressure assist mechanism can act together with the elastic tension in the positioning and stabilizing structure.

[0220] In one form, the seal formation 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). This member extends around the edge length of the plenum chamber 3200. The support flange can 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 a spring-like element or includes a spring-like element and functions to support the sealing flange so that it does not buckle during use.

[0221] In one form, a fabric membrane 3130 (e.g., including nylon, polyester, a mixture of nylon and polyester, microfiber, or polyurethane) is used as the face contact portion of a seal-forming structure 3100 for a CPAP mask. The fabric membrane 3130 can be biocompatible and can provide a substantially smooth and comfortable surface to the patient, which can lead to improved patient compliance (e.g., eliminating the need to wear irritating devices). The fabric membrane 3130 can have properties such that it can be stretched in at least one dimension. Prior to use, the fabric membrane 3130 may be permanently attached (e.g., molded), or may be attached as a removable module to a support structure (e.g., a flexible support structure 3120).

[0222] In one form, the fabric membrane 3130 can be formed in a complex three-dimensional predetermined shape such that no tension is applied (e.g., loose, relaxed and / or without small wrinkles) before and / or during use, and there is substantially no leakage that would cause small wrinkles. Since the fabric membrane 3130 can include one or more curvatures when attached to the support structure 3120, it can assist in conforming to the faces of patients with various profiles. Before the patient's face (e.g., nose) approaches and presses against the fabric membrane 3130, the fabric membrane 3130 is conformed to form a flat surface without obstructions (e.g., wrinkles, creases or small wrinkles). In some forms, this can be achieved by molding the fabric membrane 3130 such that there is substantially no leakage that would cause small wrinkles in the fabric membrane 3130. This can be advantageous as it ensures that the fabric membrane 3130 forms a smooth and continuous seal around the patient's face and its surroundings. As a result, it may be possible to improve respiratory pressure therapy by reducing the occurrence of folds or small wrinkles in the members of the seal-forming structure 3100 that can be sources of leakage of therapeutic air.

[0223] In some configurations, regions of the fabric membrane 3130 can be pre-tensioned (e.g., tensioned prior to contact with the patient's face) and slightly stretched, while other regions of the fabric membrane 3130 can remain relaxed. In other words, it may not be possible to apply pre-tension across the entire fabric membrane 3130. Applying various tensions to the fabric membrane 3130 can be advantageous in that it can improve seal efficiency while reducing pressure (i.e., "hot spots") on regions of the anthropometric features of the face that protrude into or over longer distances into the cavity 3101. In some examples, the sides of the nasal region (e.g., the lateral sides 3250 and / or the corner regions 3252) can remain unstretched and / or relaxed prior to use when providing additional material to conform to the facial profile of these sensitive facial regions. In some examples, the bridge site 3104 can extend between the two nostril openings 3102 and can be tensioned, for example, as shown in FIGS. 12-21. Applying tension to the bridge site 3104 can provide one possible way to give the fabric membrane 3130 a complex shape (e.g., multiple curvatures) to better map the shape of the patient's face and can significantly reduce the tension across the remainder of the fabric membrane 3130 (compared to, for example, the bridge site 3104). Using a wide area of the fabric membrane 3130 that is not tensioned can be more comfortable in some arrangements because using an untensioned fabric also results in less pressure on the patient's face.

[0224] By continuously holding the fabric membrane 3130 wrinkle-free both before and during use, the fabric membrane 3130 can be conformed to the profile of the patient's face while minimizing wrinkles and / or ruptures in the seal-forming structure. This can also enable, in some configurations, improvement of the seal performance by maximizing the contact area of the fabric membrane 3130 on the patient's face. This can also enable, in some configurations, improvement of the performance of the CPAP device (when subjected to impacts by external lateral or longitudinal forces (e.g., tube drag)).

[0225] In some forms, when the plenum chamber 3200 is pulled away from the patient's face by a short distance, the addition of air pressure from within the plenum chamber 3200 can assist in maintaining an effective seal in the fabric membrane 3130. The addition of air pressure can be sufficient to elastically stretch the fabric membrane 3130 in at least one dimension to form a "hovercraft"-like balloon effect over the anthropometric profile of the patient's face 1300, whereby an effective seal is maintained over the anthropometric profile of the patient's face 1300.

[0226] In some forms, the fabric membrane 3130 can be held by a relatively high-rigidity support structure 3120. In various forms, the support structure 3120 can be formed from any of, for example, silicone, PU foam, PU solid material, or another suitable material. The support structure 3120 is harder than the fabric membrane 3130, but can also be described as flexible and can bend or flex with the addition of tension. In some forms, the support structure 3120 can be relatively harder than the shell or frame of the plenum chamber 3200 (e.g., formed from rigid plastic). In other forms, the plenum chamber 3200 does not include a shell or frame and is entirely constructed by the fabric membrane 3130 and the support structure 3120.

[0227] In some forms, the magnitude of the tensile stress can be varied across the seal forming structure 3100 and the fabric membrane 3130 as needed. The bridge portion 3104 can be held in a tensioned state, and the remainder of the fabric membrane 3130 can be understood as not being stretched in contrast to the bridge portion 3104. Although an illustration shows the bridge portion 3104 provided at the center of the fabric membrane 3130, the bridge portion 3104 (or any similar feature to which tension is selectively applied) can be at any location throughout the fabric membrane 3130. However, if the location on the fabric membrane 3130 is different, the tension level can also be different (i.e., lower than either of the bridge portions 3104). For example, a stress concentration region can be present in the vicinity of one or more holes (e.g., nostril openings 3102) in the fabric membrane 3130 as a passage for therapeutic application in a more stretched material. In some examples, the region of the fabric membrane 3130 directly contiguous to the support structure 3120 (e.g., the outer periphery) can be held by a higher tension than the radial interior of the fabric membrane 3130, excluding the bridge portion 3104 which can include the highest tension.

[0228] In some forms, the seal forming structure 3100 can use a plurality of different cushion configurations (e.g., a single air assist type fabric membrane 3130, a double air assist type fabric membrane 3130, a fabric membrane 3130 including a compression support, or a fabric membrane 3130 including a TPU / TPE / Si support). In some forms, the cushion configuration of the seal forming structure 3100 can be formed to advantageously provide a "one size fits most" solution.

[0229] In an example, the seal forming structure 3100 and the plenum chamber 3200 can be applied to nasal cushions, nasal cradles, oro-nasal cushions, ultra-small full face masks, full face masks, and other suitable cushion arrangement configurations.

[0230] In some forms, the fabric membrane 3130 can be configured to create an effective seal against the subnasal point region of the patient's nose, such that the fabric membrane 3130 does not engage the apex point as shown, for example, in FIG. 23. In some forms, the fabric membrane can be configured to generate an effective seal over the apex point (not shown) of the patient's nose.

[0231] In some forms, when a load is applied to the inner surface of the fabric membrane (e.g., the air-impermeable layer 10131) due to the air pressure within the cavity 3101, creating additional tensile stress, the fabric membrane 3130 substantially fills the pressed outer contour of the patient's face 1300 (e.g., around the nasal wings, in the vicinity of the nostril edges). In some forms, the elasticity of the fabric membrane 3130, in combination with the load of the internal air pressure, elastically stretches the fabric membrane 3130 to form a larger seal contact area on the patient's face. This can be advantageous in providing a continuous seal in some forms, even if the mask is partially displaced from an optimal interface with the patient's face. This is because the fabric membrane 3130 can partially expand due to the reaction force from the internal air pressure (i.e., the "hovercraft effect").

[0232] In some forms, such as those shown in FIGS. 19-21 and FIGS. 37-39, one or more grip pads 3150, 9150 may be placed on the fabric membranes 3130, 9130. In one example, the grip pads 3150, 9150 may be configured such that either is substantially flat along the surface of the fabric membranes 3130, 9130 facing the patient. In other examples, by embossing the grip pads 3150, 9150, beads or rims may be formed in the grip pads 3150, 9150 that protrude slightly above the surfaces 3130, 9130 of the fabric membranes. In some forms, the grip pads 3150, 9150 may have a high coefficient of friction. In some forms, the grip pads 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 stretchable (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 disposed within a pattern across the surface of the seal-forming structures 3100, 9100. In some forms, the grip pads 3150, 9150 may be disposed so as to be scattered across the surface of the seal-forming structures 3100, 9100 (see FIGS. 21 and 39). In some forms, the grip pads 3150, 9150 may be disposed so as to form a perimeter adjacent to the periphery of the fabric membranes 3130, 9130 (see FIGS. 19, 20, 37, and 38). In some forms, the grip pads 3150, 9150 forming the perimeter may be in the form of a dotted line (see FIGS. 19 and 37). In some forms, the grip pads 3150, 9150 forming the perimeter may be in the form of a solid line (see FIGS. 20 and 38). In some forms, the grip pads 3150, 9150 forming the perimeter may be in the form of a plurality of lines (dotted or solid) or combinations thereof. In some forms, the grip pads 3150, 9150 may assist the fabric membranes 3130, 9130 in gripping the patient's face.In one example, the grip pads 3150, 9150 can be formed as relatively thin silicone layers added to the surfaces 3130, 9130 of the fabric membranes. In any of the above configurations, the grip pads 3150, 9150 can provide additional materials (e.g., fabric and silicone) that contact the patient's face. Although the comfort level obtained from the entire fabric surface (e.g., when only the fabric material of the fabric membrane contacts the patient's nose) cannot be obtained, by providing the grip pads 3150, 9150 on the fabric membranes 3130, 9130, the benefit can be obtained that the seal-forming structures 3100, 9100 are reliably held in place (e.g., for delivering treatment pressure to the patient). Further, since only a small area (rather than a relatively large area of fabric (or entirely silicone)) is coated with silicone (or other gripping material), the comfort for the patient can be increased compared to the case of the entire seal-forming structures 3100, 9100 formed from silicone (or other similar materials).

[0233] In some forms, the fabric membrane 3130 can be integrated with the support structure 3120 by attaching (e.g., molding) the outer edge (e.g., outer perimeter) of the fabric membrane 3130 around the curved edge lip (e.g., inner edge) of the support structure 3120. In one example, the fabric membrane 3130 is attached to provide the front surface of the seal-forming structure 3100. Since the fabric membrane 3130 also extends forward, the fabric membrane 3130 is curved in a direction away from the front surface. In other words, the fabric membrane 3130 is curved to extend beyond the front surface and provides an additional surface area of fabric material that is exposed to the patient. In this arrangement, it can be advantageous in that substantially the entire face of the patient in contact with the seal-forming structure 3100 is in contact with the fabric membrane 3130. By doing so, since contact with the fabric membrane 3130 can be more comfortable for the patient, the likelihood that the patient wears the patient interface 3000 using the fabric membrane 3130 (compared to at least some other patient interfaces 3000 that use other materials (e.g., silicone) in the face contact area) can be increased, which can be useful in improving patient adaptability.

[0234] In one example, the attachment of the fabric membrane 3130 to the support structure 3120 is performed by a specific process (as described later) that can form a portion that is curved without the occurrence of folds, wrinkles, creases, or buckling on the fabric membrane surface 3130. As will be understood, in some examples, at the transition site 36, both the support structure 3120 and the fabric membrane 3130 can have a radius of curvature (e.g., the same or a similar radius of curvature) in the direction from the front side portion to the rear side portion of the seal formation structure 3100 along the curved portion 35 (see FIGS. 16 to 18). Since a pre-specified curvature can be imparted to the fabric membrane 3130, a portion of the fabric membrane 3130 that is not directly supported by the support structure 3120 extends along the curved portion 35 (FIGS. 16 to 18). The fabric membrane 3130 can be held at a low tension with respect to the support structure 3120, but since the fabric membrane 3130 is not directly supported by the support structure 3120 (e.g., not in direct contact with the support structure 3120), the support structure 3120 can be considered to be substantially relaxed (e.g., under a lower tension than the bridge portion 3104). Thereby, the generation in a specific region (e.g., the lateral side portion 3250 and / or the corner region 3252) of the fabric membrane 3130 having a dome shape (e.g., a convex dome) can be assisted, and thereby, as shown in FIG. 12, the seal of the fabric membrane 3130 to the outer shape of the patient's face (e.g., the lowest point region of the alae nasi of the patient's face (i.e., the corner of the nasal region (i.e., the region where the wing terminates on the upper lip in the vicinity of the nasolabial groove))) can be assisted. The dome shape can assist in avoiding the formation of wrinkles, creases, folds, and buckling in the fabric membrane 3130, and thereby the occurrence of leakage paths can be assisted. Also, the dome shape can assist the fabric membrane 3130 in reaching a region where it is difficult to seal the patient's face (e.g., the corner of the nasal region). Since the fabric membrane 3130 can have a saddle shape in the intermediate subnasal point region 3260 configured to seal the subnasal point of the patient, it conforms to the saddle shape formed by the nasolabial angle and the upper lip of the patient as shown in FIG. 12. Similarly, the nasal tip point region 3270 can also have a saddle shape configured to seal the conforming profile shown at or below the nasal tip point of the patient.The curvature in the direction of the curved portion 35 of the fabric film 3130 (e.g., the magnitude of the curvature and / or the radius of curvature) can vary in different regions of the cushion assembly along the outer periphery 3130 of the fabric film. For example, as shown in FIG. 16, the fabric film 3130 in the intermediate nasal tip point region 3270 can have a curvature in the direction of the curved portion 35 that is different from that of the fabric film 3130 in the intermediate nasal subpoint region 3260. In one example, the curvature (e.g., the magnitude of the curvature and / or the radius of curvature) of the lateral side portion 3250 of the fabric film 3130 can be different from the curvature in the intermediate nasal tip point region 3270 and / or the intermediate nasal subpoint region 3260.

[0235] In some forms, the fabric film 3130 can be angled slightly inward or curved (e.g., having a positive dome curvature in the left-right direction) as it approaches the inside of the mask, as shown, for example, in FIGS. 12 - 21. In some forms, the fabric film 3130 can form a dome shape on the support structure 3120, as shown, for example, in FIGS. 26 - 33. Since any of the cushion assemblies 6105, 9105 disclosed herein can have a fabric film 6130, 9130 attached to the outer edge of the support structure 6120, 9120, a part of the seal-forming structure 6100, 9100 is formed by the fabric films 6130, 9130 and extends from the front side to the rear face contact side of the seal-forming structure along the curved portion 35 as described above with respect to FIG. 12. For example, note that the fabric film 6130 of the cushion assembly 6105 can have a greater portion of a dome shape (due to a negative curvature from one lateral side portion to the other). In other words, since the fabric film 6130 is attached to the support structure 6120 with curvatures in different directions and / or around different axes, the fabric film 6130 can be formed with both an inward curve and a dome shape. In one example, most of the fabric film 6130 includes a positive (e.g., inward) curvature that can cradle a part of the patient's face, and only the peripheral portion (e.g., the region near the support structure) is made into a dome shape (e.g., includes a negative curvature).

[0236] In some forms, the central portion of the fabric membrane 3130 has a saddle shape. In other words, the peripheral portion of the fabric membrane 3130 can be shaped to have a negative dome curvature (e.g., relative to the patient's face during use), and the central portion includes a positive dome curvature (e.g., around the bridge site 3104), so that the central portion (e.g., in the vicinity of the bridge site 3104) can be considered a minimax point and thus a saddle (e.g., relative to the patient's face during use).

[0237] In some forms where the fabric membrane 3130 is not under continuous tension (before and / or during use) or is non - elastic, the fabric membrane 3130 can form an improved air - assist seal on the patient's face. This improved air - assist seal dynamically conforms to changes / movements (i.e., a "hovercraft" effect), for example, because the fabric membrane 3130 is thinner and has lower structural rigidity than the support structure 3120 (e.g., a silicone membrane).

[0238] In some forms, the fabric membrane 3130 can be supported by a secondary or tertiary support structure that can function as a cushion support. The cushion support can provide additional flexibility and can be suitable for use on most patient faces (a one - size - fits - most). The second or third support layer can be formed using a fabric membrane, a fabric containing a PU / Si membrane, a laminated open - cell foam, a laminated PU foam, a PU molding, a TPU / TPE, or silicone. In some forms, the additional support layer itself can be supported by a structural / rigid plastic (e.g., PP / PC / PA / PET or other suitable materials).

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

[0240] In some forms, multiple 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, solid PU material, or any suitable plastic material.

[0241] In one form, the seal-forming structure can include a compression seal or a gasket seal. In use, the compression seal or gasket seal is constructed and arranged to be in a compressed state, for example, due to the elastic tension in the positioning and stabilization structure.

[0242] In one form, the seal-forming structure includes a tension portion. The tension portion can be disposed at any number of distinct locations throughout the seal-forming structure. In use, the tension portion is held in a taut state, for example, by an adjacent region of the sealing flange.

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

[0244] In certain forms of the technology, the seal-forming structure can include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension portion, and a site having an adhesive surface or an adherent surface.

[0245] 5.3.1.2 Nasal bridge or nasal sill region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the nasal bridge region or the nasal sill region of the patient's face during use.

[0246] In one form, the seal-forming structure includes a saddle-shaped region constructed to form a seal over the nasal bridge region or the nasal sill region of the patient's face during use.

[0247] 5.3.1.3 Upper lip region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the upper lip region (i.e., the upper lip) of the patient's face during use.

[0248] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over the upper lip region of the patient's face during use.

[0249] 5.3.1.4 Jaw Region In one form, the non-invasive patient interface 3000 includes a seal-forming structure configured to form a seal over the jaw region of the patient's face during use.

[0250] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over the jaw region of the patient's face during use.

[0251] 5.3.1.5 Forehead Region In one form, the seal-forming structure forms a seal over the forehead region of the patient's face when the seal is in use. In such a form, the plenum chamber may cover the eyes during use.

[0252] 5.3.1.6 Nasal Pillows In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows. Each nasal puff or nasal pillow is configured and arranged to form a seal with each nostril of the patient's nose.

[0253] A nasal pillow according to one aspect of the present technology includes a frustum of a cone. At least a portion of the frustum of the cone forms a seal over the lower side of the patient's nose, the stem, and a flexible region on the lower side of the frustum of the cone, connecting the frustum of the cone to the stem. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the stem. The flexible region may function to facilitate a self-aligning structure. The self-aligning structure accommodates the displacement and angle of the frustum of the cone and the relative movement between the frustum of the cone and the structure to which the nasal pillow is connected. For example, the frustum of the cone may be displaced axially towards the structure to which the stem is connected.

[0254] 5.3.2 Nasal Cushion Referring to FIGS. 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 technique.

[0255] The example of the seal forming structure 3100 described in the above paragraph can be regarded as a nasal cradle cushion and is intended to provide a pressurized gas flow to the patient's nostrils by sealing at least the lower side of the patient's nose. The exemplary seal forming structure 3100 engages the patient's face below the bridge of the nose and, in some examples, can engage the patient's nose below the tip of the nose depending on the size and shape of the patient's nose. The exemplary seal forming structure 3100 can also engage the patient's face at least above the upper lip. Thus, the exemplary seal forming structure 3100 can seal the patient's upper lip during use. Further, since the patient's mouth can remain exposed by the seal forming structure 3100 of the described example, the patient can breathe freely (i.e., directly from the surroundings) without interference from the seal forming structure 3100. The nasal cradle on the lower side of the nose can be configured not to have an aperture sized to receive the patient's nose within the cavity. Further, the height of the cushion 3105 from the lower edge of the fabric membrane in the middle subnasal point region to the upper edge of the fabric membrane 3130 in the middle tip of the nose region can be less than the width of the cushion 3105 in the left-right direction from one lateral edge of the fabric membrane 3130 to the other lateral edge of the fabric membrane 3130 (see, for example, FIG. 12).

[0256] An example of the nasal cradle cushion 3105 (e.g., the exemplary seal-forming structure 3100 disclosed herein) may include a superior saddle or concave region having a positive curvature across the cushion. Also, while the nasal cradle cushion 3105 may be understood as having a single target seal-forming region or surface, the pillow cushion may have two target seal-forming regions (one for each nostril). The cradle cushion 3105 may also have a rear wall portion that contacts the patient's upper lip, and the upper central surface contacts the lower side of the patient's nose (e.g., the patient's subnasale and / or columella). These two surfaces on the patient's face can form a nasolabial angle therebetween (see FIG. 2E). The cradle cushion 3105 may be shaped to have the nasolabial angle within the range of 90 degrees to 120 degrees.

[0257] Furthermore, the exemplary seal-forming structure 3100 may be shaped and sized such that no portion of the seal-forming structure 3100 substantially enters the patient's nostrils during use. In other words, a portion of the seal-forming structure 3100 may contact the nostril rim and may extend slightly inward in some orientations, but the seal-forming structure 3100 does not substantially seal the nasal passage (in contrast to, for example, a nasal pillow mask).

[0258] 5.3.2.1 Prenum Chamber Referring to FIGS. 6-21, the prenum chamber 3200 has an edge shaped complementary to the surface contour of an average person's face in the region where a seal is formed during use. During use, the peripheral edge of the prenum chamber 3200 is positioned proximate to the adjacent surface of the face. The actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around any portion of the edge of the prenum chamber 3200 during use (e.g., around the entire edge, around most of the edge, etc.).

[0259] In certain forms of the technology, the plenum chamber 3200 can be constructed of a flexible material (e.g., silicone) and 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 the plenum chamber 3200). In some examples, the seal-forming structure 3100 can be an extension of the plenum chamber 3200 such that the seal-forming structure 3100 is included in the plenum chamber 3200, or alternatively, formed as part of the plenum chamber 3200. In such examples, the support structure 3120 and the fabric membrane 3130 can be considered part of the plenum chamber 3200 (e.g., the seal-forming structure 3100 at least partially forms the internal volume of the plenum chamber 3200). In some embodiments, the plenum chamber 3200 can be constructed from a transparent material (e.g., transparent silicone). Use of a transparent material can reduce the constrictiveness of the patient interface 3000 and assist in improving compliance with treatment. Use of a transparent material can assist a clinician (or patient) in viewing the placement and function of the patient interface and in viewing the cleanliness of the patient interface 3000. Use of a transparent material enables a clinician or patient to observe accumulation of debris (e.g., dirt, mold) within the plenum chamber 3200, allowing for cleaning or replacement of the patient interface 3000. This can enable a patient to be more conscious of cleanliness when wearing the patient interface and can assist in verifying that the patient is not inhaling harmful materials, both of which can lead to improved patient acceptance. A translucent material can be used instead of or in addition to the transparent material to provide similar benefits to the patient. Alternatively, the plenum chamber 3200 can be constructed from a material that is relatively more rigid than the seal-forming structure 3100 (e.g., polycarbonate). To achieve similar benefits of a flexible transparent material (e.g., to enable viewing), the rigid material can be constructed from a transparent and / or translucent material (e.g., transparent polycarbonate).

[0260] In some forms, the seal forming structure 3100 may include a plenum chamber connection opening 3106 where the seal forming structure 3100 is hermetically joined to the plenum chamber 3200. The seal forming structure 3100 and the plenum chamber 3200 may at least partially form a cavity 3101 pressurized by an air flow. In the illustrated embodiment, the seal forming structure 3100 and the plenum chamber 3200 together form the cavity 3101. Using at least one opening (e.g., a pair of nose openings 3102) within the seal forming structure may enable fluid communication between the cavity 3101 and the patient's nostrils. However, the nose openings 3102 are not large enough to receive the patient's nose (e.g., the nasal tip point) into the cavity 3101.

[0261] The connection at the plenum chamber connection opening 3106 between the seal forming structure 3100 and the plenum chamber 3200 may be a permanent connection. The connection at the plenum chamber connection opening 3106 between the seal forming structure 3100 and the plenum chamber 3200 may be a chemical bond. The joining of the seal forming structure 3100 and the plenum chamber 3200 at the plenum chamber 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 removable connection.

[0262] On each side of the plenum chamber 3200, a hollow path can be provided as a plenum chamber inlet port formed with a size and structure such that the plenum chamber lateral end 3202 receives an air flow. The plenum chamber connector 3204 can also be provided at each lateral end of the plenum chamber 3200 outside and to the side of the plenum chamber lateral end 3202. The plenum chamber connector 3204 can 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 can be removable on both sides. In other examples, a permanent connection can 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 can be permanent on both sides.

[0263] The lateral end 3202 of the plenum chamber can receive a pressurized gas flow from the positioning and stabilizing structure 3300 (e.g., the conduit headgear). The pressurized gas flow can then pass through the plenum chamber 3200 and then through the seal forming structure 3100 and be sent into the patient's airway for inhalation.

[0264] The ends 3314 of the positioning and stabilizing structure 3300 (e.g., the openings in each conduit) can be connected to the plenum chamber lateral end 3202. In these examples, each plenum chamber connector 3204 can include a slot 3209, a chamfered edge 3208, and a notch 3206 that can be removably snap - fitted to a clip of the positioning and stabilizing structure.

[0265] 5.3.2.2 Seal - forming structure of the present technology Each seal - forming structure 3100 can 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 seal - engage with 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 of different thicknesses (e.g., two, three, four, etc. regions). For example, the seal-forming structure 3100 may include a support structure 3120 (having a wall structure having 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 portions 3123 may be adjacent to or connected to the plenum chamber 3200, and the portions 3124, 3126 may be adjacent to or connected to the fabric membrane 3130 such that structural stability in connection with the plenum chamber 3200 and flexibility in the interface with the patient are obtained. Alternatively, the thicker lateral support region 3122 may be disposed, for example, at a corner of the nasal region of the seal-forming structure (e.g., may be directly connected to the fabric membrane), so as to ensure proper sealing in the alar lowest point region of the patient's face.

[0267] Further, in the described embodiments, each fabric membrane (e.g., the seal) may include two separate nostril openings 3102, each corresponding to one of the patient's nostrils, to provide air flow to both of the patient's nostrils. A bridge portion 3104 may be provided between the nostril openings 3102. The bridge portion 3104 may assist in maintaining the desired shape of the fabric membrane 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 fabric material (e.g., nylon, polyester, a mixture of nylon and polyester, microfiber, or polyurethane) as will be described in more detail hereinafter. The sealing portion 3130 described in any of the examples of the present disclosure may be referred to as a fabric sealing portion or a fabric membrane and may include a fabric material having air impermeability (e.g., with addition applied to the material by lamination, coating, or other means).

[0269] Since the support structure 3120 may have an aperture formed therein, an inner edge of the support structure 3120 is obtained. Along this inner edge, a sealing portion 3130 (e.g., the outer periphery of the sealing portion 3130) is attached to the support structure 3120 as shown in FIGS. 12 to 21, for example, to extend the sealing portion 3130 inward in the radial direction of the seal forming structure 3100 (beyond the support structure or to an even further range than the support structure). For example, the sealing portion 3130 may be formed around the inner edge of the support structure 3120, or may be connected to the support structure 3120 by other suitable methods as described later.

[0270] Referring to FIGS. 12 to 15, the wall structure of the seal forming site 3100 may include a lateral support region 3122. The lateral support region 3122 is thicker compared to other parts of the wall structure of the support structure 3120. A lateral support region 3122 may be provided at the outermost side of each seal forming structure 3100. The seal forming structure 3100 may include two lateral support regions 3122. These two lateral support regions 3122 are respectively spaced distally from the plane that bisects the seal forming structure 3100 and is parallel to the sagittal plane of the patient during use. Since these lateral support regions 3122 may be the thickest parts of the seal forming structure 3100, resistance to lateral displacement (e.g., when a patient sleeping with their head sideways presses the pillow against the seal forming structure laterally) is obtained, and a strong engagement with the patient's wings is obtained. The thickness of the lateral support region 3122 may be approximately 0.9 mm to approximately 1.5 mm or approximately 1.3 mm to approximately 1.4 mm or approximately 1.3 mm or approximately 1 mm to approximately 1.5 mm. Since the lateral support region 3122 is the thickest region in the seal forming structure 3100 in the described figures, the lateral support region 3122 may also provide the highest resistance to deformation.

[0271] As described above, the fabric membrane 3130 can be formed such that the fabric membrane 3130 forms a part of the seal formation structure 3100 that extends curvilinearly from the front side of the seal formation structure 3100 to the rear face contact side. That is, since the fabric membrane 3130 contacts the support structure 3120 in the transition site 36, the fabric membrane site 3130 can be configured to engage the lowest alar point region of the patient's face (i.e., the region where the ala terminates at the upper lip in the vicinity of the nasolabial groove), which is a region with particularly complex geometry. The geometry of the lowest alar point region of the patient's face is particularly complex because at least three facial surfaces (ala, upper lip, and cheek) converge in this region. As a result, the seal formation structure 3100 can be made more flexible and compliant (e.g., not under tension in the vicinity of the outer periphery of the fabric membrane 3130) so that it can more easily conform to the patient's facial profile.

[0272] As described above, FIGS. 19 to 21 show the grip pads 3150 on the surface 3130 of the fabric membrane.

[0273] 5.3.2.3 Positioning and Stabilization Structure The seal formation structure 3100 of the patient interface 3000 of the present technology can be held in the sealed position by the positioning and stabilization structure 3300 during use.

[0274] In one form, the positioning and stabilization structure 3300 provides at least sufficient holding force to overcome the effect of the positive pressure in the plenum chamber 3200 that causes it to lift off the face.

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

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

[0277] In one aspect of the present technology, a positioning and stabilization structure 3300 configured to be worn by a patient during sleep is provided. In one embodiment, the positioning and stabilization structure 3300 has a non - obtrusive outer shape or cross - sectional thickness so as to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross - section. In one embodiment, the positioning and stabilization structure 3300 includes at least one flat strap.

[0278] In one aspect of the present technology, a positioning and stabilization structure 3300 is provided that is configured such that when a patient lies in a supine sleep position with the patient's head resting on a pillow in the posterior region of the head, it does not have an overly large or bulging size that would interfere.

[0279] In one aspect of the present technology, a positioning and stabilization structure 3300 is provided that is configured such that when a patient lies in a lateral sleep position with the patient's head resting on a pillow in the lateral region of the head, it does not have an overly large or bulging size that would interfere.

[0280] In one aspect of the present technology, the positioning and stabilization structure 3300 includes a release site disposed between a front portion of the positioning and stabilization structure 3300 and a rear portion of the positioning and stabilization structure 3300. This release site is not resistant to compression and can be, for example, a flexible or flimsy strap. The release site is constructed and arranged such that when the patient lies with the head on the pillow, the presence of the release site can avoid a situation where the force to the rear portion is transmitted along the positioning and stabilization structure 3300 and the seal is interfered with.

[0281] In one form of the present technology, the positioning and stabilization structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous such that moisture (e.g., sweat) can pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0282] In a particular form of the present technology, the positioning and stabilization structure 3300 includes a strap that is stretchable (e.g., stretchable with elasticity). For example, the strap can be configured to be taut during use and direct a force that causes the seal forming structure 3100 to adhere to a portion of the patient's face. In one embodiment, the strap can be configured as a tie.

[0283] In one form of the present technology, the positioning and stabilization structure includes a first tie, and the first tie is constructed and arranged such that at least a portion of its lower edge moves upward and covers a portion of the parietal bone without covering the occipital bone and reaches the upper ear base point of the patient's head during use.

[0284] In one form of the present technology suitable for a nasal mask or a full face mask, the positioning and stabilization structure includes a second tie. The second tie is constructed and arranged such that at least a portion of its upper edge passes below the lower ear base point on the lower side of the patient's head and covers the occipital bone of the patient's head or is placed below the occipital bone of the patient's head during use.

[0285] In one form of the present technology suitable for a nasal mask or a full face mask, the positioning and stabilization structure includes a third tie that is constructed and arranged to interconnect the first tie and the second tie so as to reduce the tendency of the first tie and the second tie to move in a divergent direction.

[0286] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a strap that is bendable and for example non-rigid. An advantage of this aspect is that the strap is more comfortable when the patient lies on their side during sleep.

[0287] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a strap configured to be breathable such that water vapor can pass through the interior thereof.

[0288] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilization structure 3300. Each positioning and stabilization structure 3300 is configured to provide a holding force for accommodating different sizes and / or ranges of shapes. For example, the system may include a form of the positioning and stabilization structure 3300 that is suitable for a large-sized head rather than a small-sized head and another form that is suitable for a small-sized head rather than a large-sized head.

[0289] 5.3.2.3.1 Positioning and Stabilization Structure of the Present Technology FIG. 6 shows an example of the present technology including the positioning and stabilization structure 3300. In this example, the positioning and stabilization structure 3300 includes a lateral portion 3302 and an upper portion 3304 in the form of conduits that direct the flow of pressurized gas from the hub 3306 towards the end 3314. The positioning and stabilization structure 3300 can be arranged such that the hub 3306 and the release structure 3500 are positioned above the patient's head during use. As described below, the release structure 3500 can be rotatable within the hub 3306, and when the patient is wearing the patient interface 3000, for example during treatment, the hub 3306 and the release structure 3500 are positioned above the patient's head, allowing the patient to move more freely (without getting entangled with the air circuit 4170).

[0290] The positioning and stabilization structure 3300 can be constructed of silicone. For example, the lateral portion 3302, the upper portion 3304, the hub 3306, and the lateral ends 3314 can be constructed or molded from a single piece of silicone.

[0291] Since the upper portion 3304 of the positioning and stabilization structure 3300 has peaks and valleys (or bellows), the shape of the upper portion 3304 can be made to correspond to the shape of the corresponding part of the patient's head during use. The peaks and valleys of the upper portion 3304 allow the upper portion 3304 to be extended or contracted along the longitudinal axis so as to correspond to larger or smaller heads. The peaks and valleys of the upper portion 3304 allow the upper portion 3304 to be bent to different radii of curvature so as to correspond to patient heads of different shapes and sizes.

[0292] The lateral portion 3302 of the positioning and stabilization structure 3300 need not be formed with the peaks and valleys of the upper portion 3304. Therefore, it may be advantageous to make the extensibility and flexibility of the lateral portion 3302 lower than that of the upper portion 3304, since the shape and size variability of the sides of the patient's head is reduced.

[0293] The ends 3314 can be connected to each plenum chamber lateral end 3202. As described above, the plenum chamber lateral end 3202 receives a pressurized gas flow from the positioning and stabilization structure 3300. This pressurized gas flow reaches the patient's airway through the plenum chamber 3200 and the seal forming structure 3100. As described above, the ends 3314 can be connected to the plenum chamber connectors 3204 of each plenum chamber lateral end 3202.

[0294] The positioning and stabilization structure 3300 can be structured and arranged to direct the force / tension provided from the lateral portion 3302 into a partially upward and partially rearward force vector that is applied to the plenum chamber 3200. Specifically, this partially upward and partially rearward force vector causes the fabric membrane of the seal forming structure 3100 to make a sealed contact under the patient's nose (e.g., at or below the tip of the nose and at least above the upper lip vermilion).

[0295] Also, each of the lateral portions 3302 can include a tab 3308 that receives the rear strap end 3311 of the rear strap 3310. The rear strap 3310 can be length adjustable, for example, by a hook and loop material arrangement configuration, such that hook material is provided externally at one of the rear strap ends 3311 and the remainder of the rear strap 3310, and loop material is provided externally at the other. Thus, since the rear strap 3310 is length adjustable, the tension on the lateral portion 3302 can be increased to pull on the seal forming structure 3100 to seal - engage it with the patient's face at a desired amount of pressure (i.e., tightly enough to avoid leakage and not so tightly as to cause discomfort).

[0296] By providing a sleeve 3312 on the lateral portion 3302, the patient's face can also be cushioned and protected from the lateral portion 3302. The sleeve 3312 can be constructed of a soft - feeling breathable fabric material. After removing the end 3314 from the plenum chamber lateral end 3202, the sleeve 3312 can be removable from the lateral end 3302.

[0297] In some forms (see FIG. 7), the positioning and stabilization structure 6300 can include a fabric tube 6350 having a left arm 6305 and a right arm 6307. The fabric tube 6350 can be formed with a first side configured to contact the patient. This can be referred to as the inner layer 6352. The fabric conduit can also include a second side. This second side is attached to the inner layer 6352, faces in the opposite direction from the patient, and can be referred to as the outer layer 6354. The inner layer 6352 and the outer layer 6354 can be fixed to each other along the edges of the inner layer 6352 and the outer layer 6354, respectively, such that a flow path or passageway is formed between the seams of the inner layer 6352 and the outer layer 6354. That is, the space between the seams remains unfilled and forms the air passage 6372. The inner layer 6352 and the outer layer 6354 can be joined using various techniques that impart specific attributes to the seams or joints. For example, in some forms, ultrasonic welding, high-frequency welding, as well as cutting and welding techniques are used to form the seams. Adding heat to a specific area activates the thermosetting or thermoplastic material used in the tube 6350. This heat can be used not only for joining the layers to each other but also for thermoforming layers such as the outer layer 6354. Further, in some forms, adhesion such as stitching or an adhesive can be used to join the layers to each other. In some forms, stitching is not used. In further forms, materials beyond those disposed within the layers are not used in joining the inner layer 6352 and the outer layer 6354 of the tube. For example, in some forms, the inner layer 6352 and the outer layer 6354 can be formed such that additional materials such as adhesives or stitching are not required in joining the inner layer 6352 and the outer layer 6354.

[0298] The inner layer 6352 and the outer layer 6354 may 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 in the opposite direction from the inner layer 6352, and the outer surface of the inner layer 6352 faces in the opposite direction from the outer layer 6354. Further, in a form including a single sheet, the inner surface is the surface of the sheet and is disposed inwardly or disposed toward itself.

[0299] In some forms, the sheet or the sheet of the tube may include an air-impermeable layer or membrane. In some forms, the inner surfaces of both layers include a membrane configured to limit or inhibit the passage of air 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 woven sheet of the inner layer or the outer layer. In other forms, the impermeable layer may exceed the thickness of the woven sheet of either layer. The impermeable layer or membrane or film may be made completely impermeable to air movement, or may be formed to allow a predetermined rate or air movement and a specific pressure.

[0300] Since the membrane can be formed of a thermoplastic or thermosetting material, when exposed to a specific temperature, after shaping or forming the membrane material into a specific form, it can be cured or solidified or solidified by cooling. In some forms, the membrane can be formed of silicone or polyurethane. In some forms, by pre-forming the outer layer 6354, in an unpressurized or supported state, the outer layer 6354 is pre-positioned and pre-formed to extend in a direction away from the inner layer 6352 between the opposing joints 6312. That is, since the outer layer 6354 can support its own weight, even without being supported by pressurized air or other support mechanisms, the outer layer 6354 remains spaced from the inner layer 6352 between the joints 6312.

[0301] In contrast, the inner layer 6352 can be a flexible component. When the inner layer 6352 is attached and fixed to the edge of the outer layer 6354, the inner layer 6352 becomes a substantially planar layer.

[0302] As shown in FIG. 8 and particularly as shown in FIG. 9, the inner layer 6352 includes a fabric sheet 6360 together with a membrane 6362. The fabric sheet 6360 can be formed of felt, foam material, woven fabric, knitting, or non-woven fabric material or other fiber mesh.

[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 by 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 surface 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 in forming an airtight tube. The membrane 6370 can assist in joining the tube sheet 6364 to the outer covering 6366.

[0304] 5.3.2.4 Ventilation part In one form, the patient interface 3000 includes a ventilation part 3400 configured and arranged to allow the extrusion of exhaled gas (e.g., carbon dioxide).

[0305] In a particular form, the ventilation 3400 is configured to allow a continuous ventilation flow from the inside of the plenum chamber 3200 to the atmosphere when the pressure in the plenum chamber is positive with respect to the atmosphere. The ventilation part 3400 is configured such that, while maintaining the treatment pressure in the plenum chamber during use, the magnitude of the ventilation flow rate is large enough to reduce the rebreathing by the patient of the exhaled CO2.

[0306] One form of the ventilation part 3400 according to the present technology includes a plurality of holes (e.g., about 20 to about 80 holes or about 40 to about 60 holes or about 45 to about 55 holes).

[0307] The ventilation part 3400 can be arranged inside the plenum chamber 3200. The ventilation part 3400 can include a plurality of holes as described above. The holes of the ventilation part 3400 can be divided into two groups arranged at intervals in the lateral direction. Since the axes of the flow paths passing through each of the holes of the ventilation part 3400 can be parallel, cross flow is avoided, and further noise generation is avoided. The ventilation holes can be circular.

[0308] The radius of the holes of the ventilation part 3400 may be such that it becomes smaller from the inside to the outside of the plenum chamber 3200. A draft gradient is provided for each ventilation hole. The diameter of each hole is smaller at the front end than at the rear end. The draft gradient helps to provide an effective carbon dioxide wash flow at high humidity levels because the cross-section of the hole does not become smaller across the entire chassis thickness. Furthermore, as the draft gradient increases, the manufacture of the plenum chamber 3200 can become easier (especially when the plenum chamber 3200 is formed from an injection-molded plastic material). The draft gradient enables the use of relatively thick ventilation pins in the mold and easier injection.

[0309] The holes of the ventilation part 3400 can be provided as two sets toward the middle part of the plenum chamber 3200, and these sets can be symmetric across the center line of the plenum chamber 3200. Providing a pattern of a plurality of ventilation holes can enable noise reduction and dispersion of flow concentration.

[0310] The hole portion of the ventilation part 3400 can be arranged at an optimal distance in the direction away from the center line of the plenum chamber 3200. Arranging the hole portion of the ventilation part 3400 toward the center line may reduce the possibility of the ventilation hole being blocked when the patient is sleeping in a lying position, which may be advantageous. However, if the ventilation hole is placed too close to the middle part of the plenum chamber 3200, the cross-section of the plenum chamber 3200 in the example described is minimized at the center (due to the overall shape of the plenum chamber 3200), so the plenum chamber 3200 may become excessively weak at the center. Depending on the location of the hole portion of the ventilation part 3400, it is possible to avoid blocking of the hole portion during lying-down sleep while keeping the middle member of the chassis sufficiently strong.

[0311] Regarding the optimization of the size and number of each ventilation hole, optimization can be performed so as to achieve a balance between noise reduction while achieving the necessary carbon dioxide flushing even in extreme humidification. In the example described, the overall ventilation volume of the system cannot be obtained from the ventilation holes of the ventilation part 3400. The decoupling structure 3500 may include a decoupling structure ventilation part 3402. The decoupling structure ventilation part 3402 may include one hole portion or a plurality of hole portions through the decoupling structure 3500. The decoupling structure ventilation part 3402 can perform a function of bleeding off excessive pressure generated by the RPT device 4000 (before reaching the patient), while the ventilation part 3400 can perform a function of flushing 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 can be constructed of a material that is more flexible than the material of the plenum chamber 3200. In one example, a heat and moisture exchange (HME) material (e.g., foam) is housed within a removable vent to humidify the air the patient inhales (without the need for a separate humidifier). The vent insert can be removable to allow the patient to replace the HME material with a fresh clean sheet of HME material (after a period of time). Additionally, the entire vent structure can be replaced (as opposed to, for example, just the HME material alone).

[0313] 5.3.2.5 Disengagement structure(s) In one form, the patient interface 3000 includes at least one disengagement structure (e.g., a swivel or ball and socket).

[0314] The hub 3306 described above is connected to a disengagement structure 3500. The disengagement structure 3500 is a rotatable elbow in these examples. The disengagement structure 3500 can be rotatable 360° within the hub 3306 during use. The disengagement structure 3500 can be removable from the hub 3306 by manually pressing a button 3504 that releases a catch (not shown) from within the hub 3306.

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

[0316] The disengagement structure 3500 being rotatable, the disengagement structure 3500 being in the form of an elbow, and the swivel 3502 being rotatable on the disengagement structure 3500 can all lead to an increase in degrees of freedom, which in turn can lead to a reduction in tube resistance and torque on the patient interface 3000 due to the connection to the air circuit 4170.

[0317] 5.3.2.6 Connection Port The connection port 3600 enables 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 Valve In one form, the patient interface 3000 includes an anti - asphyxiation valve.

[0320] 5.3.2.9 Port In one form of the present technology, the patient interface 3000 includes one or more ports that enable access to the volume within the plenum chamber 3200. In one form, this enables a clinician to supply supplemental oxygen. In one form, this enables direct measurement of the characteristics (e.g., pressure) of the gas within the plenum chamber 3200.

[0321] 5.3.3 Full - Face Mask Cushion Referring to FIGS. 26 - 33, the 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 nostrils and mouth (e.g., an oro - nasal cushion assembly or a sub - miniature full - face mask). The cushion assembly 6105 is at least partially formed by the seal - forming structure 6100 attached to a plenum chamber and the plenum chamber 6200 according to an example of the present technology.

[0322] Referring to FIGS. 22-25 and FIGS. 34-39, cushion assembly 9105 is illustrated. Cushion assembly 9105 is similar to cushion assembly 6105 and has a seal forming structure 9100. Seal forming structure 9100 is configured to separately seal around a patient's nostrils and mouth (e.g., an oro-nasal cushion assembly or a sub-miniature full face mask). Cushion assembly 9105 is at least partially formed by a seal forming structure 9100 and a plenum chamber 9200 attached to a plenum chamber according to an example of the present technology.

[0323] Cushion assembly 9105 includes a nose portion 9101, a nose portion aperture 9103, a mouth portion 9102, a mouth portion 9104, a cavity 9001, a support structure 9120, a sealing portion 9130, and a ventilation portion 9400, which are similar to the features shown in FIGS. 26-33. The description of FIGS. 26-33 generally applies to FIGS. 22-25 and FIGS. 34-39, and numerous similarities and differences will not be discussed separately. A pair of plenum chamber apertures are configured to receive an air flow.

[0324] The cushion assembly 9105 (e.g., specifically the nasal portion 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 side to the back side of the cushion assembly 9105 (e.g., see FIG. 24). A similar curvature may be provided to the cushion assembly 6105 (e.g., see FIGS. 30 and 31). However, in contrast to the cushion assembly 6105, the cushion assembly 9105 (e.g., specifically the nasal portion 9101) may include at least one curved surface. This may be obtained by crimping in the nasal portion 9101. This will be described in more detail below. When the cushion assembly 9105 is in use, the curved surface of the cushion assembly 9105 obtained from crimping 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 obtained from crimping may curve around an axis perpendicular to the axis passing through section line 36--36 (e.g., see FIG. 34) and / or around a third axis 13000 (detailed later). The curved surface obtained from crimping may also have a positive curvature with respect to the patient's face.

[0325] As described above, FIGS. 37 - 39 show the grip pad 9150 on the surface of the fabric film. The grip pad 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 pad 9150 may also be used within the cushion assembly 6105.

[0326] Referring to FIG. 33-1, the patient interface 21000 includes a cushion assembly 21105 having a seal-forming structure 21100. The seal-forming structure 21100 is configured to seal around the patient's nostrils and mouth (e.g., an oro-nasal cushion assembly or a subminiature full-face mask). The cushion assembly 21105 is similar to the cushion assemblies 6105 and 9105. The cushion assembly 21105 is at least partially formed by a seal-forming structure 21100 and a plenum chamber 21200 attached to a plenum chamber according to an example of the present technology. The seal-forming structure 21100 may also have a curved surface such as the nasal site 9101.

[0327] Referring to FIG. 33-2, the patient interface 23000 includes a cushion assembly 23105 having a seal-forming structure 23100. The seal-forming structure 23100 is configured to seal around the patient's nostrils and mouth (e.g., an oro-nasal cushion assembly or a subminiature full-face mask). The cushion assembly 23105 is similar to the cushion assemblies 6105 and 9105. The cushion assembly 23105 is at least partially formed by a seal-forming structure 23100 and a plenum chamber 23200 attached to a plenum chamber according to an example of the present technology. The seal-forming structure 23100 may also include a curved surface such as the nasal site 9101.

[0328] Referring to FIGS. 33-3 to 33-11, the patient interface 25000 includes a cushion assembly 25105 having a seal-forming structure 25100. The seal-forming structure 25100 is configured to seal around the patient's nostrils and mouth (e.g., an oral-nasal cushion assembly or a subminiature full-face mask). The cushion assembly 25105 is similar to the cushion assemblies 6105 and 9105. The cushion assembly 25105 is at least partially formed by a seal-forming structure 25100 and a plenum chamber 25200 attached to a plenum chamber according to an example of the present technology. The seal-forming structure 25100 may also include a curved surface such as the nose portion 9101.

[0329] The full-face cushions of FIGS. 22 to 39 may have a certain similarity to the nasal cushion 3000 described above. For example, the seal-forming structure, described in more detail later, may have a selectively applied tension to assist in forming the resulting shape (e.g., a two-dimensional shape or a three-dimensional shape). Various similarities and differences between the full-face cushion and the nasal cushion 3000 are described below.

[0330] 5.3.3.1 Plenum Chamber The plenum chamber 6200 has an edge shaped to be complementary to the surface contour of an average person's face in the region where a seal is formed during use. During use, the peripheral edge of the plenum chamber 6200 is positioned close to the adjacent surface of the face. The 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 during use.

[0331] In certain forms of the present technology, the plenum chamber 6200 is constructed from a relatively high-rigidity material (e.g., polycarbonate) compared to the seal-forming structure 6100. In another example, the plenum chamber 6200 is constructed from a flexible material (e.g., silicone, fabric) and may have a rigidity similar to that of the seal-forming structure 6100. In another embodiment, the plenum chamber 6200 may be constructed from a transparent material (e.g., transparent polycarbonate). The use of a transparent material can reduce the pressing force of the patient interface 6000 and can assist in improving compliance with treatment. The use of a transparent material can assist a clinician in viewing the placement and function of the patient interface 6000 and / or observing the accumulation of debris (e.g., dust, mud, mold, etc.).

[0332] In certain forms of the present technology, the plenum chamber 6200 is composed of a translucent material. By using a translucent material, the pressing force of the patient interface 6000 can be reduced, and improvement in compliance with treatment can be assisted.

[0333] The plenum chamber 6200 according to an embodiment of the present technology may include plenum chamber holes on each side surface. The plenum chamber holes can provide pneumatic communication between the conduit connector 6800 (described in more detail below) and the cavity 6001. The connection rim portion around each plenum chamber hole can facilitate mechanical connection (e.g., snap fit or friction fit) with each conduit connector. Since the plenum chamber 6200 can be composed of a material with sufficient rigidity, when the conduit connector 6800 is connected to or removed from the plenum chamber 6200, auditory and / or tactile feedback can be delivered to the patient.

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

[0335] 5.3.3.2 Seal Forming Structure Referring to FIGS. 26-33, the seal forming structure 6100 may include a nose portion 6101 having at least one hole (e.g., a pair of nose site holes 6103) for sealing a patient's nostril and transferring pressurized air to the patient's nostril. In the described embodiment, two separate holes 6103 are provided, each corresponding to one of the patient's nostrils, to provide an air flow to both of the patient's nostrils. A bridge portion 6106 may be provided between the nostril openings 6103. In another example, a single hole may be used to provide a pressurized flow to both of the patient's nostrils. In a further alternative, more than three holes may be provided. In contrast to the bridge portion 3104, tension cannot be selectively applied to the bridge portion 6106. For example, rather than applying tension only to the bridge portion 6106, the surrounding material of the bridge portion 6106 and the nose portion 6101 may be held under tension together.

[0336] Referring briefly to FIGS. 22-25 and 34-39, the bridge portion 9106 may be selectively tensioned in a manner similar to the bridge portion 3104. For example, the bridge portion 9106 may be in a more tense state than the surrounding first sealing portion 9131.

[0337] Continuing with reference to FIGS. 26 - 33, the seal - forming structure 6100 may include an oral site 6102 having an oral site aperture 6104 for sealing the patient's mouth. In some examples, the oral site 6102 is at least partially under tension when not in use (i.e., when not in contact with the patient's face) (e.g., at any number of separate locations). For example, the oral site may be under tension at its junction with the support structure 6120 while being relaxed on the exposed sealing edge (e.g., the inner edge near the opening of the cavity 6001). In some examples, the entire oral site 6102 is in a relaxed state when not in use. In any of these examples, contact with the patient's face can cause the oral site 6102 to stretch and be under tension during use.

[0338] The seal - forming structure 6100 may at least partially form a cavity 6001 that is pressurized by an 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 fabric membrane). The sealing portion is configured to seal - engage with the patient's face. The sealing portion 6130 is large enough (e.g., curved forward by a sufficient amount) such that only the sealing portion 6130 (e.g., only the fabric membrane) contacts and seal - engages with the patient's face. Alternatively, the support structure 6120 may be constructed of a fabric material.

[0340] In one example, the seal-forming structure 6100 can include a support structure 6120 having at least two regions of different thicknesses (e.g., two, three, or four regions) (e.g., the seal-forming structure 6100 has a wall structure having a laterally supporting region that is thicker (compared to other portions of the wall structure)) (e.g., see 3122 in FIGS. 58 and 59). For example, as shown in FIGS. 58 and 59, some portions 3123 of the support structure 3120 can be thicker than portions 3124, 3126 of the support structure 3120. For example, the thicker portion 3123 can be adjacent to or connected to the plenum chamber, and portions 3124, 3126 can be adjacent to or connected to the fabric membrane 3130, so as to obtain structural stability in the connection to the plenum chamber 3200 and flexibility in the interface with the patient. Alternatively, the thicker portion of the laterally supporting region 3122 can be arranged, for example, at the corner of the nasal region of the seal-forming structure (e.g., can be directly connected to the fabric membrane), so as to ensure proper sealing in the region of the lowest point of the alae nasi of the patient's face.

[0341] As described above, the seal-forming structure 6100 may be hermetically connected to the plenum chamber 6200. The support structure 6120 can be less rigid than the plenum chamber 6200 and can be constructed from silicone, foam (e.g., polyurethane foam), polyurethane solid material, thermoplastic elastomer (e.g., thermoplastic polyurethane), a suitable plastic, or other suitable materials as described later. Further, the sealing portion 6130 can be less rigid than the support structure 6120 and can be constructed from a fabric material 6130 (e.g., nylon, polyester, nylon and polyester mixture, microfiber, or polyurethane as described in more detail later, for example).

[0342] In the example of FIG. 32, the support structure 6120 can extend into a cavity 6001 that forms 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 foamed material (e.g., polyurethane foam). In another example, the lower cushion 6122 can be constructed of silicone as shown in FIG. 33. However, it is recognized that the lower cushion can be constructed of other suitable materials (e.g., fabric).

[0343] The sealing portion 6130 can be constructed of two different pieces of fabric film. For example, one piece 6131 can be used to seal around the patient's nose while a separate piece 6132 can be used to seal around the patient's mouth. The sealing portions 6131, 6132 can be used to independently seal around each orifice. In other words, the first or upper sealing portion 6131 can contact the area around the patient's mouth while the second or lower sealing portion 6132 cannot contact the area around the patient's nose.

[0344] As shown in FIGS. 26 - 33, the first sealing portion 6131 is disposed at the upper portion (i.e., in use) of the patient interface 6000 as compared to the second sealing portion 6132. The first sealing portion 6131 forms a generally oval (e.g., generally triangular oval) perimeter to seal around the patient's nostrils in use.

[0345] In some forms, the first sealing portion 6131 can contact the area between the nasal wing and the upper lip while leaving the nasal tip point exposed (see FIGS. 23-25 showing a similar first sealing portion 9131 for example). The fabric film of the first sealing portion 6131 can 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. Thereby, the patient can contact only the fabric layer of the bedding (which is closer to the patient than the medical device) in this area of the patient's face, so that the improvement of patient adaptability can be supported.

[0346] The second sealing portion 6132 is disposed at a lower position (i.e., relative to the first sealing portion 6131 of the patient interface 6000 during use). In the illustrated example, the second sealing portion 6132 generally forms a U-shaped configuration and a seal around a portion of the patient's mouth. The fabric film forming the second sealing portion 6132 does not extend over the entire perimeter of the patient's mouth. In other words, when forming the seal around the patient's mouth, materials other than the fabric film can contact the patient. In this example, to complete the mouth site 6104, a support structure 6120 (e.g., a silicone material) is molded between the free ends of the second sealing portion 6132. The fabric film of the second sealing portion 6132 can contact the lower lip of the patient, the area outside the commissure points of the patient, and a portion of the upper lip of the patient, and cannot contact the central portion of the upper lip of the patient (e.g., in the vicinity of the philtrum of the patient). The support structure 6120 extends between the ends of the second sealing portion 6132 across the philtrum of the patient. The combination of the fabric film of the sealing portion 6130 and the silicone material of the support structure 6120 can have the function of generating a seal around the patient's mouth.

[0347] The support structure 6120 extends from the lower surface 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 aids in the interconnection of 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 across the entire perimeter of the patient's mouth. In other words, the fabric membrane contacts the philtrum, in contrast to the support structure 21120. The support structure 21120 (e.g., silicone material) is disposed in the lower / upper 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). The support structure 21120 may contact the patient's upper lip slightly, but the sealing is mainly or exclusively achieved through the fabric membrane within the first sealing portion 21130a and the second sealing portion 21130b. In other words, the location where the support structure 21120 contacts the patient's skin is not pressurized and / or may be exposed to the atmosphere during treatment. By extending the second support structure 21130b to the perimeter of the patient's mouth, the comfort of the patient may be increased (e.g., since the patient may find the fabric membrane more comfortable than silicone) compared to the U-shaped second sealing structure 21130b, which may result in an increase in the patient's treatment compliance.

[0349] In another example of the patient interface 23000, as shown in FIG. 33-2, the second sealing portion 23130b is in a U-shaped configuration. However, the philtrum and the central portion of the upper lip contact the fabric membrane. In this example, the first sealing portion 23130a extends downward to the edge of the mouth site 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 horizontally in the left-right direction between the first sealing portion 23130a and the second sealing portion 23130b). This example may provide a comfort benefit similar to that 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 by contact with the fabric membrane). However, in the case of the example of FIG. 33-2, manufacturing may be easier because the support material 23120 between the first sealing portion 23130a and the second sealing portion 23130b is removed in the up / down direction. The small portion of the support structure 23120 between the first sealing portion 23130a and the second sealing portion 23130b may assist in forming a pressurized volume around the patient's mouth.

[0350] In other examples of the patient interface 25000, as shown in FIGS. 33-3, the sealing portion 25130 is formed by a single piece of fabric material. In other words, the first sealing portion 25130a and the second sealing portion 25130b are not constructed by 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 an outer perimeter similar to that described above (e.g., as in the example of the patient interface 25000 having the first and second sealing portions 25130). In some examples, if the patient's upper lip is not sealed, it can lead to air leakage from the seal formation structure 25100, so the sealing portion 25130 may be sealed only at the outer perimeter. However, the sealing portion 25130 may seal the patient's upper lip so that pressurized air is delivered more directly to the patient's airway. By using a single piece of fabric membrane to form the sealing portion 25130, the support structure 25120 does not have to contact the patient's upper lip. Further, since it is not necessary to form the thin elongated strips of the support structure 25120 between two pieces of fabric membrane to connect these fabric membrane pieces, the manufacture of the patient interface can be made easier. Thus, by simplifying the molding process, it is not necessary to flow a small amount of a material such as silicone in between, and the fabric layer 10133 is also not coated.

[0351] As shown in FIGS. 22-25 and FIGS. 31-1 to 39, each seal formation structure may all have a three-dimensional shape. Specifically, each first sealing portion may have a curved surface (e.g., in the left-right direction) symmetrically with respect to the flat surface (e.g., in the left-right direction) shown in FIGS. 26-33. The three-dimensional shape may be formed by at least partially applying selective tension to the bridge portion of each first sealing portion. Tension is not applied to the material of the first sealing portion surrounding the bridge portion on each seal formation structure so that the first sealing portion includes a curved shape.

[0352] In any of these embodiments (e.g., FIGS. 22 - 39), the seal strength against the patient's face is substantially the same. For example, using the fabric material alone or in combination with fabric and silicone materials has substantially no effect on the quality of the seal (i.e., increase or decrease in the leakage area). Different patients (e.g., different face geometries) may be more suitable in one of the specific examples than in other examples (e.g., due to comfort, fit). Further, in cases where the fabric covering is larger, although the patient's further comfort may increase, 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 Stabilization Structure The seal - forming structure 9100 of the patient interface 9000 of the present technology can be held in the sealed position by the positioning and stabilization structure 9300 during use. Specifically, although the positioning and stabilization structure 9300 is illustrated with the patient interface 9000, the positioning and stabilization structure 9300 can be used with any of the full - face cushions (e.g., any of the examples in FIGS. 22 - 39). The positioning and stabilization structure 9300 may also be similar to the positioning and stabilization structure 3300.

[0354] In one form, the positioning and stabilization structure 9300 provides at least sufficient holding force to overcome the effect of the positive pressure in the cavity 9001 for lifting off the face.

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

[0356] In one form, the positioning and stabilization structure 9300 provides holding force as a safety margin to eliminate the possibility of destructive actions on the patient interface 9000 (e.g., caused by tubing drag or accidental interference with the patient interface).

[0357] In one aspect of the present technology, a positioning and stabilization structure 9300 configured to be worn by a patient during sleep is provided. In one embodiment, the positioning and stabilization structure 9300 has a low profile or cross-sectional thickness so as to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilization structure 9300 includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilization structure 9300 includes at least one flat strap.

[0358] In one aspect of the present technology, a positioning and stabilization structure 9300 is provided that is configured to not be overly large or bulky such that it would interfere with a patient sleeping in a supine sleep position with the patient's head resting on the rear region of the patient's head on a pillow.

[0359] In one aspect of the present technology, a positioning and stabilization structure 9300 is provided that is configured to not be overly large or bulky such that it would interfere with a patient sleeping in a lateral sleep position with the patient's head resting on the side region of the patient's head on a pillow.

[0360] In one aspect of the present technology, the positioning and stabilization structure 9300 includes a release site disposed between a front portion of the positioning and stabilization structure 9300 and a rear portion of the positioning and stabilization structure 9300. This release site is not resistant to compression and can be, for example, a flexible or flimsy strap. The release site is constructed and arranged such that when the patient lies with their head on a pillow, the presence of the release site can avoid a situation where the force to the rear portion is transmitted along the positioning and stabilization structure 9300 and the seal is interfered with.

[0361] In one form of the present technology, the positioning and stabilization structure 9300 includes a strap composed of a laminate of a fabric patient contact layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous such that moisture (e.g., sweat) can 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 delivering air to the cushion assembly 9105 can also constitute the positioning and stabilization structure 9100.

[0362] In a particular form of the present technology, the positioning and stabilization structure 9300 includes a strap that is stretchable (e.g., stretchable with elasticity). For example, the strap can be configured to be taut when in use and direct a force that causes the seal-forming structure to adhere to a portion of the patient's face. In one embodiment, the strap can be configured as a tie.

[0363] In one form of the present technology, the positioning and stabilization structure can include a first tie (e.g., the upper strap 9302 (FIG. 24)). The first tie is constructed and arranged such that at least a portion of its lower edge moves upward and passes over to the upper ear base point of the patient's head during use.

[0364] In one form of the present technology suitable for a full-face mask, the positioning and stabilization structure includes a second tie (e.g., the lower strap 9303 (FIG. 24)). The second tie is constructed and arranged such that at least a portion of its upper edge passes below the lower ear base point on the lower side of the patient's head and covers the occipital bone of the patient's head or is placed below the occipital bone of the patient's head during use.

[0365] In one form of the present technology suitable for a nasal-only mask or a full-face mask, the positioning and stabilization structure includes a third tie (e.g., the strap connector 9304 (FIG. 22)) constructed and arranged to interconnect the first tie and the second tie so as to reduce the tendency of the first tie and the second tie to move in a separating direction.

[0366] In certain forms of the technology, the positioning and stabilization structure 9300 includes a strap that is bendable and, for example, non-rigid. An advantage of this aspect is that the strap is more comfortable when the patient lies on their side during sleep.

[0367] In certain forms of the technology, the positioning and stabilization structure 9300 includes a strap configured to be breathable such that water vapor can pass through it.

[0368] In certain forms of the technology, a system is provided that includes more than one positioning and stabilization structure 9300. Each positioning and stabilization structure is configured to provide a holding force for accommodating different sizes and / or ranges of shapes. For example, the system can include one form of the positioning and stabilization structure 9300 suitable for a large-sized head rather than a small-sized head and another form suitable for a small-sized head rather than a large-sized head.

[0369] The positioning and stabilization structure 9300 can include a clip 9301 for securing each tie to the conduit connector 9800, as shown, for example, in FIG. 22. The clip 9301 and the conduit connector 9800 each have magnets with opposite polarities disposed thereon to facilitate the connection therebetween.

[0370] 5.3.3.4 Ventilation In one form, the patient interface 6000 includes a ventilation portion 6400 configured and arranged to allow the expulsion of exhaled gas (e.g., carbon dioxide), as shown in FIG. 30.

[0371] In certain forms, the ventilation 6400 is configured to allow a continuous flow of ventilation from the interior of the plenum chamber 6200 to the atmosphere when the pressure within the plenum chamber is positive relative to the atmosphere. The ventilation 6400 is configured such that, during use, while maintaining the therapeutic pressure within the plenum chamber, the magnitude of the ventilation flow rate is large enough to reduce rebreathing of exhaled CO2 by the patient.

[0372] One form of the vent 6400 according to the present technology includes a plurality of holes (e.g., about 20 to about 80 holes or about 40 to about 60 holes or about 45 to about 55 holes).

[0373] The vent 6400 can be disposed within the plenum chamber 6200. Alternatively, the vent 9404 is disposed within a disconnect structure (e.g., a swivel (see FIG. 22)).

[0374] The conduit connector 6800, which will be described in more detail below, may also include a vent feature.

[0375] 5.3.3.5 Disconnect Structure(s) In one form, the patient interface 9000 includes at least one disconnect structure (e.g., a swivel or ball and socket).

[0376] 5.3.3.6 Connection Port The connection port 6600 enables connection to the tube 6348 of the air circuit 4170 (see FIG. 7). The connection port 9600 according to an embodiment of the present technology can be connected to a connection port housing 9903 (see FIG. 22). The connection port 9600 can be rotatable relative to the connection port housing 9903, and the connection to the air circuit 4170 can also be rotatable.

[0377] The connection port 9600 and the connection port housing 9903 can be disposed above the patient's head during use.

[0378] 5.3.3.7 Forehead Support The embodiments of the patient interface of the present technology shown in FIGS. 22 - 39 do not include a forehead support. Variations of the patient interface of the present technology may include a forehead support.

[0379] 5.3.3.8 Conduit The patient interface 9000 according to an embodiment of the present technology may include a conduit 9900 for supplying a pressurized air flow from a connection port 9600 to a cavity 9001 within a plenum chamber 9200. The conduit 9900 may be similar to the lateral portion 3302 and the 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 a connection port housing 9903 and may pass between corresponding ones of the patient's eyes and ears along the lateral side of the patient's head. The conduit 9900 may be connected via a conduit connector 9800 to a cushion assembly 9105 (e.g., a plenum chamber 9200) to provide a pressurized air flow to the cavity 9001, as described below.

[0380] The conduit 9900 may also enable stabilization and positioning of the seal-forming structure 9100 on the patient's face. Thus, the conduit 9900 may function similarly to the tie of the positioning and stabilization structure 9300. Thus, the mechanical connection from the conduit 9900 to the conduit connector 9800 may be sufficient to conduct the tensile force 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 WO2017 / 124155A1. The entire content of this document is incorporated herein by reference for all purposes. For example, the conduit 9900 of the present technology may include the features of the headgear tube 3350 described in FIGS. 3A - 3L of this document and the related description.

[0382] By providing a sleeve 9901 on the conduit 9900, the patient's face can also be protected from the conduit 9900 like a cushion. The sleeve 9901 may be removable. The sleeve 9901 may be composed of a breathable material.

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

[0384] 5.3.3.9 Conduit Connector As shown in FIGS. 26-33, patient interface 6000 may include some views of conduit connector 6800 of patient interface 6000, according to an embodiment of the present technology. The conduit connector may connect a conduit to cushion assembly 6105 to provide a flow of pressurized air to cavity 6001. These conduit connectors 6800 may be similar to conduit connector 9800 (see, e.g., FIGS. 22-25), and the following description may apply equally to conduit connector 9800.

[0385] Each of the conduit connectors 6800 may be formed with a conduit connector housing 6801. The conduit connectors 6800 may provide other functions as described below (e.g., ventilation of the plenum chamber 6200, connection to a positioning and stabilization structure, and prevention of asphyxiation by inclusion of an asphyxiation prevention valve 6850).

[0386] In FIGS. 26 - 33, the state where the conduit connector 6800 is attached to the plenum chamber 6200 at the plenum chamber holes (for example, refer to similar plenum chamber holes 9210) is illustrated. As can be understood, one conduit connector 6800 is provided on each side of the cushion assembly 6105, and each conduit connector 6800 is connected to the plenum chamber hole at each corresponding side of the cushion assembly 6105. Each of the conduit connectors 6800 may include a conduit connector attachment structure for connecting each of the conduit connectors 6800 to each plenum chamber hole at a connection rim (not shown). This connection can be mechanical (for example, snap fit or friction fit). This connection can also be removable. The material of the conduit connector 6800 and the material of 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 can each be relatively rigid so as to enable audible feedback and / or tactile feedback in relation to 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 aspect, 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 can be ultrasonically welded to the plenum chamber 6200. The connection between the conduit connector 6800 and the plenum chamber 6200 is designed to be either removable or permanent and sufficiently robust so as to be able to send the tension from the conduit to the plenum chamber 6200 (without interfering with the connection). Because, as described above, the conduit connector 6800 can facilitate the positioning and stabilization of 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 so as to improve the aesthetics of the patient interface 6000. As described above, by configuring the plenum chamber 6200 with a transparent or translucent material, visual recognition of the patient-facing features may be enabled. For example, by providing the conduit connector 6800 on the side of the plenum chamber as shown in the illustrated embodiment, a larger view of the patient's face can be obtained, and with this arrangement configuration, improvement in the aesthetics of the patient interface 6000 becomes possible. This is in contrast to alternative designs where the elbow and air circuit can be joined to the center of the plenum chamber 6200 and the patient's face is obstructed.

[0388] Each conduit connector 6800 may also include a conduit connection end 6802 for connecting to each conduit (e.g., similar to the conduit 9900 of FIG. 22). The connection between the conduit and the conduit connector 6800 at the conduit connection end 6802 may be removable or may be permanent. The conduit connector inlet hole 6803 may be formed in the conduit connector housing 6801 at the conduit connection end 6802 so as to receive the pressurized air flow. The conduit connector 6800 may include a structure (e.g., an undercut) to facilitate a removable snap-fit connection with the corresponding conduit. Each conduit may include, at its end, a relatively high-rigidity structure for connecting to the conduit connector 6800 so as to facilitate such a connection. The conduit connector 6800 may be joined to the conduit by friction fit, snap fit, or any similar fit. Here too, as described above, since the conduit provides a positioning and stabilization function for installing a seal-forming structure at a therapeutically effective sealing position on the patient's face, the connection between the conduit and the conduit connector 6800 at the conduit connection end 6802 can be made sufficiently secure to transmit the tensile force 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] As shown in FIG. 29, the ventilation function of the patient interface 6000 can also be obtained by the conduit connector 6800. The conduit connector housing 6801 may include a ventilation inlet that is in pneumatic communication with the cavity 6001 during the assembly of the patient interface 6000. The conduit connector housing 6801 may also include at least one conduit connector vent hole 6831. As can be seen from the illustrated embodiment, each conduit connector housing 6801 includes a plurality of conduit connector vent holes 6831. As a result, it becomes possible to appropriately mix the newly introduced air and the existing air in the plenum chamber 6200, thereby improving the extrusion of carbon dioxide and increasing the amount of fresh air provided to the patient for breathing.

[0390] As shown in FIGS. 22 to 24, the connection of the positioning and stabilization structure 9300 to the tie can also be obtained by a similar conduit connector 9800. The lower tie can be joined to the conduit connector 9800 by a clip 9301. The clip 9301 and the conduit connector 9800 may include magnets having opposite polarities for facilitating connection. The connection between the tie of the positioning and stabilization structure 9300 and the conduit connector 9800 may be releasable. The tension from the lower tie of the positioning and stabilization structure 9300 can urge the lower part of the seal forming structure 9100 to make a sealed 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 of the conduit connectors 6800 may include an anti-asphyxiation valve assembly 6850. Thus, the patient interface 6000 may include two anti-asphyxiation valve assemblies 6850. The anti-asphyxiation valve assemblies 6850 may each operate independently of one another (i.e., in response to a cessation of pressurized air flow). For example, if the pressurized air flow stops and one of the anti-asphyxiation valve assemblies 6850 is blocked (e.g., by a pillow) when the patient is lying on their side, the other anti-asphyxiation valve assembly 6850 can function to avoid asphyxiation of the patient. Although not explicitly shown, the patient interfaces of FIGS. 22-25 and 33-1 to 39 may also include at least one anti-asphyxiation valve.

[0392] 5.3.3.11 Ports 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 enables a clinician to supply supplemental oxygen. In one form, this enables direct measurement of the properties (e.g., pressure) of the gas within the plenum chamber 6200. Although not explicitly shown, the patient interfaces of FIGS. 22-25 and 33-1 to 39 may also include at least one port.

[0393] 5.3.4 Support Structure and Sealing Port Arrangement The support structure and sealing portion of the above example may have a plurality of different configurations and arrangements.

[0394] In use, the sealing contact between the sealing portion 3130 (e.g., a fabric membrane) and the patient's face can be maintained by: 1) the reaction stress of the support structure 3120; 2) the pre-formed state of the fabric membrane 3130 that is not tensioned and is formed as a substantially flat surface without leaks that cause obstructions (e.g., wrinkles, folds, buckles or creases) in the fabric membrane 3130; and / or 3) the air pressure within the cavity against the inner surface of the sealing portion 3130. Each of these elements can contribute to the sealing portion 3130 conforming to the anthropometric profile of the patient's face, thereby achieving minimization of wrinkles or ruptures and maximization of the contact area of the sealing portion 3130. The tension in the sealing portion 3130 can increase due to any of these elements, but if the relevant elements are removed, the sealing portion 3130 can return to a relaxed state.

[0395] In some examples, the sealing portion 3130 can include a relatively thin, compliant and stretchable elastic material (e.g., a fabric membrane including a suitable fabric material such as nylon, polyester, nylon and polyester mixtures, microfibers or polyurethane). Since the sealing portion 3130 can be formed onto the support structure 3120 or otherwise attached (e.g., by adhesion, use of an adhesive) to the support structure 3120, wrinkles in the material of the sealing portion 3130 are eliminated. This can be advantageous as it ensures the formation of a smooth continuous seal by the sealing portion onto the patient's face (without using any bending sections that could cause air leakage). Additionally, the sealing portion 3130 can be shaped or have curvature imparted to it. Curvature can also be imparted to the sealing portion 3130 from the support structure 3120. In the illustrated example, the sealing portion 3130 can include curvature about multiple axes. This can assist in shaping the outer profile by the sealing portion 3130 to complex face structures of different patients.

[0396] For example, as shown in FIGS. 12 to 21, the sealing portion 3130 may have a concave curved profile (e.g., a positive dome curvature in the left-right direction) from one lateral side (right) to the opposite lateral side (left) in order to cradlingly support the patient's nose when the patient interface 3000 is worn. In other words, the curvature of the sealing portion 3130 is positive with respect to the location where the patient's nasal column and / or subnasal point contacts the sealing portion 3130.

[0397] In some forms, for example as shown in FIGS. 11 - 39, the patient's nose is not intended to be received within cavity 3101 formed by plenum chamber 3200 and seal - forming structure 3100. Instead, in contrast to conventional masks, the patient's nose is intended to be pressed against fabric membrane 3130, and as a result, fabric membrane 3130 comfortably forms a reliable seal against the patient's airway corresponding to the outer shape of the patient's face. The fabric membrane 3130 can stretch to conform to the patient's face. Specifically, the fabric membrane 3130 in FIGS. 11 - 21 and the fabric membranes in FIGS. 31 - 1 - 39 can be held in a relatively relaxed state (i.e., without added tension) prior to contact with the patient. When the patient contacts the fabric membrane 3130 (e.g., via their nose), due to the compliant and stretchable nature, a seal - forming structure 3100 is formed against the patient's face (e.g., the patient's nose). In other words, upon contact with the patient's face, when tension is applied to the fabric membrane 3130, a complementary shape is formed against the patient's nose. By relaxing the seal - forming structure 3100 in its initial form, the locations that can withstand shape changes are reduced, and thus an improvement in conforming to the patient's face (compared to when the seal - forming structure 3100 is initially under tension) can be achieved. By way of example, the bridge site 3104 can function to assist in providing a sealing portion that presses against the patient's nose rather than receiving the patient's nose within cavity 3101 by eliminating a central opening within the fabric membrane 3130. According to the bridge site 3104, upon addition of tension from the patient to the fabric membrane 3130, locations can be obtained where the seal - forming structure 3100 fits snugly and / or closely against the features of the patient's face (e.g., for limiting and / or avoiding leakage). Also, a different sealing experience compared to conventional masks can be obtained. Such a sealing experience can result in improved comfort due to contact with the compliant fabric membrane 3130 compared to conventional masks of stiffer materials or conventional sealing arrangements where the contact area of the sealing portion 3130 with the nose and / or around the mouth is small.The bridge portion 3104 (or any optionally tensioned region) provides a location where tension can be applied from the patient to the fabric membrane 3130 (regardless of whether the bridge portion 3104 is located adjacent to at least one hole).

[0398] The fabric membrane 6130 (e.g., the first sealing portion 6131) can be held in a relatively tense state before contact with the patient (e.g., the first sealing portion 6131 can be under continuous tension). When the patient contacts the fabric membrane 6130 (e.g., via their nose), due to its compliant and stretchable properties, the seal-forming structure 6100 is formed against the patient's face (e.g., the patient's face). In other words, contact with the patient's face adds additional tension to the fabric membrane 6130 and forms a complementary shape against the patient's nose. The first sealing portion 6131 provides a location where the seal-forming structure 6100 can be made to fit and / or be tight against the features of the patient's face due to the addition of tension from the patient to the fabric membrane 6130 (e.g., for limiting and / or avoiding leakage), so the entire first sealing portion 6131 can function in a manner similar to the above-described bridge portion 3104. While the fabric membrane 6130 is taut, the material can have sufficient flexibility or stretchability such that additional tension can cause the material to conform to the features of the patient's face. The combination of pre-tensioning in the first sealing portion 6131 and the pressurized seal obtained from the pressurized air flow can result in a more robust seal compared to a seal using only the pressure obtained from the pressurized air flow (such as in patient interfaces 3000, 9000, 21000, 23000, 25000).

[0399] Compared to conventional silicone membrane pressed compression foam seals, the sealing portions 3130 in some of the present examples have a higher flexibility structural rigidity, and thus have dynamic spring-back characteristics, which enables the sealing portions 3130 to recover more quickly when obstructed by an external force. Further, due to the lower structural rigidity, the required seal force is also reduced, making the sealing portions 3130 more comfortable and reducing facial scarring during use.

[0400] The fabric membrane 3130 can exhibit variable tension across the material (for example, it can exhibit lower tension near the nostril opening 3102 or in the vicinity of more stretched material). Since the central portion of the fabric membrane 6130 may be unsupported or somewhat relaxed compared to the periphery of the fabric membrane 6130, the fabric membrane 6130 may be under lower tension near the nostril opening 6103. In some forms, the material surface of the sealing portion that contacts the patient's face (for example, 3130) can have low friction characteristics (for example, a low friction finish), which is advantageous because it can improve patient comfort and lead to improved material adaptability to the patient's face.

[0401] The fabric membrane 3130 can exhibit variable tension across the material (for example, it can exhibit higher tension near the bridge site 3104). The fabric membranes 9130, 21130, 23130, 21530 can exhibit similar variable tension. In some forms, the material surface of the fabric membrane 3130 that contacts the patient's face can have low friction characteristics (for example, a low friction finish), which is advantageous because it can improve patient comfort and lead to improved material adaptability to the patient's face.

[0402] In some examples, the lower cushion layer(s) (for example, part or the second wall portion 3126) can assist in optimizing the contact surface area of the sealing portion 3130 with the patient's face. Further, in an example where the sealing portion 3130 is constructed from a breathable material (for example, a breathable fabric), the lower cushion layer(s) can provide a sufficient contact area at the rear side of the sealing portion, so that the sealing portion with the patient's face is properly sealed and leakage is avoided.

[0403] The lower cushion layer(s) can provide additional flexibility and make the cushion suitable for use on the face of most patients (e.g., it can fit most in one size). For example, the sealing portion can be constructed as follows: a double air assist type sealing portion (e.g., a double fabric film), a sealing portion including a compression support layer(s) (e.g., open cell foam, polyurethane foam, gel), a sealing portion provided with a TPU, TPE or silicone support layer(s), or a double air assist type sealing portion provided with an additional support layer(s) (e.g., a double fabric film with a foam laminate layer (e.g., open cell, polyurethane) provided on the inner membrane or a TPU, TPE, polyurethane or silicone molding layer placed thereon).

[0404] During use, the engagement between the patient's face 1000 and the sealing portion 10130 generates a temporary distortion force that attempts to pull the wall portions of the support structure 10120 towards each other as shown in FIG. 43. The support structure 10120 responds to this distortion force with an outward pulling reaction force. Due to the reaction force, by preferentially stretching the more compliant sealing portion, the spring force generated within the sealing portion is applied to the patient's face, causing more tension to move to the sealing portion 10130.

[0405] By forming the sealing part 10130 on the inner edge of the support structure 10120 or in other cases attaching the sealing part 10130 to the inner edge of the support structure 10120, the sealing part 10130 can be integrated with the support structure. Thus, for example, when attaching the outer periphery of the sealing part 10130 to the inner edge of the support structure 10120, the sealing part 10130 can be extended inward in the radial direction of the seal forming structure so as to extend beyond the support structure 10120 or over a wider range than the support structure 10120. Since the inner edge of the support structure 10120 can be curved, the sealing part 10130 can be slightly angled inward toward the inside of the mask. By attaching the sealing part 10130 along the inner edge of the support structure 10120, it becomes unnecessary to crease or cut the sealing part 10130 to conform to the corners of the support structure 10120. Thereby, the occurrence of protruding creases or wrinkles (which may cause leakage) in the sealing part 10130 can be advantageously reduced, and thereby the seal performance can be improved.

[0406] 5.3.4.1 Woven fabric film According to an example of the technology of the present disclosure, the seal forming structure 3100 may include a woven fabric film 3130 including a woven fabric material (see, for example, 10133). An airtight film / film or layer may be coated on the woven fabric material or added in other cases to obtain an air-retaining woven fabric composite. After cutting (for example, die cutting, ultrasonic, laser or RF) the woven fabric composite into a desired shape, it can be attached to the support structure 3120. The obtained woven fabric sealing part 3130 (or woven fabric film) can be attached to the support structure 3120 (for example, silicone, TPE) by, for example, overmolding or injection molding. In another example, the woven fabric sealing part 3130 can be heat welded onto the material (for example, silicone, TPE) of the support structure 3120 at its own edge (outer periphery). In another example, the woven fabric sealing part 3130 is not connected to the support structure 3120, and the cushion interface 3105 can be substantially constructed of a woven fabric material.

[0407] In one example, the fabric material 10133 is a stretchable fabric. By way of example, there is a knitted material, a fabric material or any other suitable material. A knitted material may be preferred because using a knitted material can provide elasticity (e.g., stretchability) in the fabric (especially as compared to a fabric material). This can be advantageous as comfort for the patient is obtained as described below. The elasticity can be obtained in all directions (e.g., four-way stretch / elasticity (e.g., substantially equal elasticity in all directions)), and can be obtained at least in the lateral left-right direction of the fabric membrane. The fabric material can have, for example, a weft-knit structure or a warp-knit structure. The fabric material 10133 can also have any other suitable knitting structure. A weft-knit structure is more desirable because the elasticity of a weft-knit fabric is higher than that of a warp-knit fabric.

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

[0409] 5.3.4.1.1 Manufacturing The various outer shapes included in the human face can be described as having positive or negative curvature and as dome regions or saddle regions. To enhance patient comfort, the seal-forming structure 3100 ideally or substantially matches these outer shapes. However, as described above, the seal-forming structure 3100 needs to be smooth and continuous on the patient's face without any need for bending sections that can be a path for air leakage. Therefore, it is necessary to form a seal-forming structure 3100 with a complex geometry with multiple curvatures to complement the patient's face without generating surfaces where leakage is likely to occur.

[0410] As shown in FIG. 49, a fabric material (e.g., fabric film 3130) can be bent about a single axis 11000 (e.g., a horizontal axis as shown in FIG. 49). In this state, the fabric material 3130 has a negative dome curvature (e.g., is substantially convex), as shown in FIG. 49. The fabric material 3130 is substantially smooth in this orientation (e.g., the curvature has a constant radius R). In other words, when the fabric material 3130 is oriented with a fold about a single axis 11000, there are substantially no small wrinkles and / or creases. This is true regardless of the axis of bending or the direction in which the fabric material 3130 is bent. In other words, the fabric 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 fabric material 3130 remains substantially free of small wrinkles and / or creases. Further, even if the magnitude of the curvature is changed, no small wrinkles and / or creases are generated in the fabric material. In other words, a single fold in the fabric material can include a large radius of curvature or a small radius of curvature without the generation of small wrinkles and / or creases in the fabric material. Thus, different positive and negative curvatures (e.g., as shown in FIGS. 3B - 3C and 3E - 3F) can be applied to the fabric material without the generation of small wrinkles and / or creases.

[0411] To account for the complex surface orientations of patients (and differences between individual patients), a seal-forming structure 3100 including a plurality of folds for increased contact with the patient's face is more desirable. Since the curvature on the patient's face exists around various axes oriented in multiple directions, it is ideal for these curves to be around different non-parallel axes. However, as shown in FIG. 50, providing additional (e.g., second, third, fourth) folds to the fabric material can cause creases and / or wrinkles. Creases and / or wrinkles can occur when two or more folds occur along non-parallel axes 11000, 11500. In other words, not all of the multiple folds along parallel axes cause creases and / or wrinkles, but they also do not generate an optimal three-dimensional shape for sealing with the patient's face (e.g., because it does not conform to the contour of the patient's face). By providing curvature along non-parallel axes, the surface may not be able to be maintained as smooth and continuous. Thus, for any seal-forming structure 3100 generated from a fabric including two or more folds, there is a low likelihood of forming an effective seal against the patient's face.

[0412] One way to effectively generate curvature in the material along a plurality of non-parallel axes is to apply tension to at least a portion of the fabric material 3130. By applying tension, the formation of creases and / or wrinkles can be restricted and / or avoided while assisting in maintaining shapes with various curvatures.

[0413] As one method of applying tension, there is a method of stretching the stretchable textile material 3130 and applying a plurality of curvatures onto the textile material under tension (e.g., along a plurality of non-parallel axes). Next, a process (e.g., thermoforming) is applied to the textile material 3130 so that the textile material 3130 can be permanently held in a distorted state (i.e., with a plurality of curvatures). As shown in FIG. 51, the textile material 3130 includes a plurality of curvatures and its surface remains relatively smooth. Therefore, this textile material 3130 can be employed within the patient interface 3000 as the seal-forming structure 3100 to provide a seal to the patient's face without substantially causing any leakage of pressurized air from the plenum chamber 3200 to the atmosphere. In this example, substantially the entire textile material 3130 is under tension.

[0414] However, after the textile material 3130 is stretched and thermoformed (or a similar process is applied), the textile material 3130 substantially loses its free-state characteristics. For example, the elasticity that the textile material 3130 may naturally have is substantially lost after the thermoforming is completed. The textile material 3130 after being stretched once becomes relatively stiff while including a plurality of curvatures. The free-state (i.e., before thermoforming) characteristics of the textile material 3130 (e.g., drape, flexibility, elasticity) are also important in determining the sealing ability of the final textile seal-forming structure 3100. Therefore, when the textile material 3130 is no longer in its free state, the quality of the seal produced by the textile material 3130 may also decrease in the case of some patients. In other words, the curved textile material 3130 formed using thermoforming may fit more comfortably against the patient's face (e.g., compared to a textile film 3130 formed with only a single bend), and when the free-state characteristics of the curved textile material 3130 are lost, the ability of the patient interface 3000 to effectively seal some patients' faces may be impaired. Although there are no creases and / or wrinkles, in the case of the seal-forming structure 3100 formed in this way, leakage may still occur (e.g., because the textile film 3130 is too stiff to fit some patients' faces). In the case of other patients, a seal sufficient to prevent leakage may be obtained.

[0415] In the case of the fabric material 6130 of FIGS. 26 to 33, since the material includes free state characteristics, the above does not apply. Since the first sealing portion 6131 is intended to be substantially flat before use, there is no need to thermoform the material for shape retention. Nevertheless, the material can stretch and conform to the patient's face. Thus, the fabric material 6130 can limit leakage, in contrast to the examples described above. Since the fabric material 6130 cannot include complex curvatures, the patient interface 6000 can also be easier to manufacture.

[0416] FIGS. 52 to 61 show another method of applying tension to only a portion of the fabric membrane 3130. For example, less than half of the fabric membrane 3130 can be placed under tension while the remaining portion of the fabric membrane 3130 can be loose or in a relaxed state. Thus, tension is selectively applied to different locations of the fabric membrane 3130. Tension can be applied to different locations (e.g., central portion, lateral portions) of the fabric membrane 3130 to assist in imparting different shaped curvatures. Further, more than one location within a single fabric membrane 3130 can be placed under tension. Selective application of tension to the fabric membrane 3130 can be performed using any number of techniques. Some of such techniques are described below.

[0417] One exemplary technique for selective application of tension to only a portion of the fabric membrane 3130 can be achieved by adding crimps to a portion of the fabric membrane 3130. By the crimps, local tension can be applied without placing the entire fabric membrane 3130 under tension. The crimps can be added to any site(s) of the fabric membrane 3130. In some examples, the crimps are not applied to most of the fabric membrane 3130. In other words, the region of the fabric membrane 3130 that is crimped is smaller than the region of the fabric membrane 3130 that is not crimped. In some examples, a member of the fabric material 3130 can be removed on at least one side of at least one of the crimped sites. In some examples, holes or other discontinuities are not required for the formation of the crimped sites.

[0418] In some examples, the crimp can be added to the central portion of the fabric membrane 3130. The crimp addition can be achieved by removing a member of the fabric material 3130 when the fabric is in a free state (i.e., when it has not yet been thermoformed) (e.g., for the formation of the holes 3102). Thereafter, the fabric material 3130 can be manipulated around the generated holes 3102 to limit the formation of creases and / or wrinkles. These holes 3102 can later be used as nostril openings (as a delivery passage for pressurized air to the patient's nostrils).

[0419] As shown in FIG. 52, the fabric material 3130 used in the nasal patient interface 3000 is illustrated. Two holes 3102 are cut out (e.g., by hand, laser, etc.) in the fabric material, and each hole 3102 corresponds to a single nostril of the patient. However, depending on the end use of the fabric material, any number of holes 3102 can be cut out (e.g., a single opening for both nostrils, additional openings for the oral cavity). The cutting out of these holes 3102 within the fabric material 3130 is performed either before or after the creation of the first fold. The order of the formation of the single (i.e., first) fold and the cutting out does not substantially affect the presence of wrinkles and / or creases.

[0420] With particular reference to the textile material used in a nose-only mask as shown in FIG. 52, the apertures 3102 are each elongated and generally formed in a rectangular shape, although other shapes (e.g., circular, triangular) may be used in other examples. These apertures 3102 can be separated by a strip of elongate material that can be formed as the bridge portion 3104. The bridge portion 3104 may be formed independently of the apertures 3102. When more than two apertures 3102 are cut out in the textile material 3130, multiple bridge portions 3104 can be obtained. Generating more bridge portions 3104 can be useful when additional apertures are needed and / or when the textile material 3130 is larger (e.g., so that the textile material 3130 does not buckle even when the bridge portion 3104 is single). As described above, the patient's nose (e.g., the tip of the nose) can contact the bridge portion 3104, and the bridge portion 3104 can limit the situation where the patient's nose extends into the plenum chamber 3200.

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

[0422] In some forms, after the bridge portion 3104 is bent, a space 3180 is created between the holes 3102. Specifically, the holes 3102 can be oriented vertically (as shown, for example, in FIG. 53), and the space 3180 is oriented along a first axis 11000. In other words, each of these holes 3102 is substantially perpendicular to the first axis 11000, and the space 3180 exists between the openings of each of the holes 3102. The width of the space 3180 substantially corresponds to the width between the patient's nasal wings or between the nasal wing ridges. In other words, the width of the space 3180 is large enough to be able to receive the patient's nose and generally align the patient's nostrils with these holes. When the nose is placed within the above space, the apex of the fabric material 3130 (i.e., that created by the first fold) contacts the patient in the vicinity of the nasolabial groove.

[0423] As shown in FIG. 54, after bending the bridge portion 3104 around a second axis 12000, the material is crimped to maintain the "inverted" orientation. Crimping can be one way to selectively apply tension to a portion of the fabric membrane 3130 (without applying tension to the entire fabric membrane 3130). Other selective tensioning techniques can also be used with or instead of crimping. The bridge portion 3104 is maintained such that there is no longer a first curvature 10000 around the first axis 11000. For example, the bridge portion 3104 may not explicitly have a positive dome curvature (e.g., the magnitude of the curvature of the bridge portion 3104 can be smaller in FIG. 54 than in FIG. 53, the curvature of the bridge portion 3104 can be zero, etc.). However, the bridge portion 3104 does not have a negative dome curvature with the remaining portion of the fabric material 3130 (e.g., when the cushion assembly 3105 is in use). In other words, after the crimping is performed, the curvature of the bridge portion 3104 is different (e.g., in magnitude and / or orientation) compared to the remaining portion of the fabric material 3130.

[0424] In some examples, the crimping of the bridge site 3104 is done such that only the material forming the bridge site is placed under tension (i.e., the tension due to crimping is not imparted to the remainder of the fabric membrane 3130). Specifically, the length of the bridge site 3104 is refolded to reduce the overall exposed length. The tension in the fabric including the crimped bridge site 3104 is higher than the tension in the surrounding uncrimped fabric. Thus, the surface of the bridge site 3104 can be substantially flat and / or can have a minimal curvature (e.g., the curvature around the first axis 11000 is retained through the remainder of the fabric material 3130). The crease in the bridge site 3104 can be provided substantially centrally, such that the lengths of the material on either side of the crease line are substantially equal, although one side may be made longer than the other. Tension is generated by the crimp, but the bridge site 3104 can flex relative to the aperture 3102 (e.g., due to the fabric free state characteristics). The crimped bridge site 3104 can be similar to the uncrimped bridge site 6106 (since both are under tension), but retains the free state material characteristics.

[0425] In other examples, other tensioning methods can be used to create the tensioned bridge site 3104 and / or tension can be applied to other locations on the fabric membrane 3130.

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

[0427] In some examples, the bridge portion 3104 is held in the crimped state by ultrasonic welding and / or adhesive addition (e.g., an adhesive), but any suitable method can be used. Any of these methods can be applied to the unusable length 3184 of the bridge portion 3104. For example, an adhesive can be applied to selected portions of the fabric layer of the fabric membrane 3130 and these selected portions are folded together. In other words, the available length of the bridge portion 3104 is substantially free of all added materials. The crimped region of the bridge portion 3104 can have the positive dome curvature described above even after one of the above fixation methods is applied.

[0428] In one example, a portion of the unusable portion 3184 of the bridge portion 3104 can be trimmed or cut out after application of the above fixation method. After the fabric membrane 3130 is fully assembled as the seal forming structure 3100, the unusable portion 3184 can be disposed within the plenum chamber 3200 and can obstruct the airflow (e.g., generate noise). Thus, if the unusable portion 3184 is trimmed, all obstructions can be reduced or eliminated.

[0429] As shown in FIGS. 55-57, after the crimping is completed, further curvatures around different axes can be applied to the fabric material 3130. By crimping the bridge portion 3104, the total area 3188 affected by the further curvatures can be reduced. In other words, the affected area 3188 (i.e., the shaded portion shown) and the crimped bridge portion 3104 in FIG. 55 are smaller than the affected area 3190 in FIG. 51 where no crimping has been performed. The affected areas 3188, 3190 are related to regions where wrinkles and / or small wrinkles are likely to occur (due to multiple curvatures in the fabric material 3130). When the bridge portion 3104 is crimped, the affected area 3188 comes substantially adjacent to the hole portion 3102. For example, the affected area 3188 can form a substantially rectangular shape, and the edges are substantially tangent to the hole portion 3102. Thus, by disposing the affected area 3188 adjacent to the hole portion 3102, the occurrence of wrinkles and / or small wrinkles when further curvatures are used in the fabric material 3130 is substantially avoided.

[0430] In some examples, the third curvature 30000 is formed around the third axis 13000 in the fabric material 3130. The third axis may extend in a direction substantially perpendicular to the first axis 11000 and the second axis 12000 (although it may be an oblique direction). 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 fabric material 3130 and extends along the bridge site 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 curved in a positive direction and may cradle the patient's nose after the patient wears the patient interface 3000. That is, the fabric layer 10133 is a saddle-shaped region around the third axis 13000, particularly 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 extend around substantially perpendicular axes and may 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 being applied, the first curvature 10000 and the second curvature 20000 remain at the previously curved positions. In other words, when the third curvature 30000 (or an additional curvature) is applied, there is substantially no effect on the magnitude and / or direction of the previous curvature.

[0431] In some examples, the fourth curvature 40000 may be formed about a fourth axis 14000 in the fabric material 3130. The fourth axis 14000 may extend along a direction that is 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 the bridge site 3104. The fourth curvature 40000 may extend toward the center of the fabric material 3130 and may be a saddle-like 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 wears the patient interface 3000.

[0432] In some examples, a fifth curvature 50000 may be formed in the fabric material 3130 around a fifth axis 15000. The fifth axis 15000 extends along a direction that is substantially parallel to and offset from the first axis 11000 and the second axis 12000 (however, the fifth axis 15000 may 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 site 3104. The fifth curvature 50000 may include an orientation similar to the first curvature 10000 and may be a negative dome curvature (e.g., as shown in FIG. 56). The first curvature 10000 and the fifth curvature 50000 may have different magnitudes of curvature (e.g., the magnitude of the first curvature 10000 may be in a more negative direction than the fifth curvature 50000). The fifth curvature 50000 may have a variable curvature because the radius of curvature may not be constant along the length of the axis 15000. For example, since the fifth curvature 50000 and the first curvature 10000 are along substantially parallel axes, changing the radius of curvature of the fifth curvature 50000 may combine the two curvatures 10000 and 50000 (e.g., they may be mixed into one curvature). The fifth curvature 50000 may have a smaller radius of curvature near the center (e.g., near the intersection with the third axis 13000) and a larger radius of curvature near the edge of the fabric material 3130. Here, the larger radius of curvature of the fifth curvature 50000 may be mixed with the first curvature 10000 (e.g., near the edge of the fabric material 3130). In other words, as the radius of curvature in the fifth curvature 50000 increases, the fifth curvature 50000 may extend into the first curvature 10000. The mixing of the curvatures may assist in providing a smooth surface and limiting the possibility of the formation of wrinkles and / or creases in the bent fabric material 3130.

[0433] In some examples, both the fourth curvature 40000 and the fifth curvature 50000 are included on the fabric material 3130. In other words, the intermediate subnasal point region 3260 of the final seal-forming structure 3100 constructed from the fabric material 3130 can include both the fourth curvature 40000 and the fifth curvature 50000. These curvatures 40000 and 50000 can cooperate to seal a compound curvature (e.g., multiple curvatures in multiple directions) on the patient's upper lip. In the illustrated example, when both the fourth curvature 40000 and the fifth curvature 50000 are provided on the fabric material 3130, the fourth curvature 40000 is the primary curvature of the intermediate subnasal point region 3260. For example, a human head has a natural curvature as it approaches either lateral side. In other words, the upper lip curves and extends from the philtrum to the commissure points on the left and right sides of the patient's face. The upper lip can also include a curvature around a substantially horizontal axis that extends perpendicular to the sagittal plane. However, this curvature extends over a smaller distance (i.e., the distance between the subnasal point and the upper vermilion is shorter than the width of the mouth) and can vary more greatly among different patients (e.g., some patients may have a more defined curve that is larger than that of other patients).

[0434] The fourth curvature 40000 is a greater curvature compared to the fifth curvature 50000. By way of example, there is a fabric material 3130 that extends around the fourth axis 14000, and the lower edge of the fabric material 3130 is bent around the fifth axis 15000, so the total area of the fourth curvature 40000 is larger on the fabric material 3130. However, the crimped bridge site 3104 enables both curvatures 40000 and 50000 to be maintained within the overlapping region (without the formation of wrinkles and / or creases). Thus, in some examples, the fifth curvature 50000 can extend along a curved path because it does not entirely follow the fifth axis 15000 but instead follows the length of the fourth curvature 40000.

[0435] In some patients, since they may have a substantially vertical upper lip between the subnasale and the upper vermilion, there may be substantially no curvature along a substantially horizontal axis perpendicular to the sagittal plane. In the case of these patients, the fifth curvature 50000 does not include the curvilinear lip region to be sealed. However, the material of the fifth curvature 50000 can be deformed into a substantially vertical (e.g., flat) region, and even when deformed, it can maintain an effective seal against the patient's face. Further, the height between the subnasale and the upper vermilion can vary from patient to patient. For example, this distance can be extremely small. In this example, the fabric material of the fifth curvature 50000 can be deformed into a tight region and can function as an introduction for forming an effective seal at any height. In other examples, the fabric material can be customizable for individual patients, and the curvature and radius of curvature are selected based on the geometry of a particular patient's face (e.g., something that can be determined using scanning).

[0436] Applying any number of these curvatures to a single seal-forming structure 3100 can assist in improving the fit of the patient interface 3000 to the patient's face. For example, all five of these curvatures can be applied to a single seal-forming structure 3100. In other examples, only several of these curvatures can be applied to the seal-forming structure 3100. In other examples, more than five curvatures can be applied to the seal-forming structure 3100. The magnitude and / or direction of these curvatures can be variable across the individual cushion assemblies 3105 (e.g., the fabric film 3130 can be made individually for each patient).

[0437] In some examples, the shape of the fabric membrane 3130 can be formed and the fabric membrane 3130 can be connected to the lateral support region 3122. In the illustrated example, the fabric membrane 3130 and the lateral support region 3122 are connected by injection molding so as to be integrally formed with each other. In other examples, the fabric membrane 3130 and the lateral support region 3122 can be coupled to each other in different ways (e.g., overmolding). In still other examples, the fabric membrane 3130 may not be connected to the lateral support region 3122.

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

[0439] As shown in FIGS. 58 and 59, a material (e.g., silicone) can be molded onto the fabric membrane 3130. The material can be added to the inner layer 3194 of the fabric membrane 3130 (e.g., a layer coated with an air-impermeable material 10131) so as to avoid covering a portion of the fabric on the back surface (and the possibility of contact with the patient's face during use). However, in other examples, the material can be added to the outer layer 3196 of the fabric membrane 3130. The material can extend into the plenum chamber 3200 beyond the ends of the fabric membrane 3130 (e.g., the material can be shaped such that a portion of the lateral support region 3122 does not contact the fabric membrane 3130). When the material is molded onto the fabric membrane 3130, the resulting support structure 3120 can have substantially the same curvature (i.e., size and direction) as the adjacent fabric membrane 3130 (e.g., for the production of a substantially smooth and continuous surface). The thickness of the material (i.e., the lateral support region) can vary along its length. For example, the lateral support region 3122 can become thicker distally from the fabric membrane 3130. Further, the overall thickness of the overlapping fabric membrane and material can be thinner than an adjacent region that includes only the molded material (i.e., the lateral support region 3122).

[0440] As shown in FIG. 58, some examples of the patient interface 3000 may include a single wall lateral support region coupled to the fabric membrane 3130. A single wall of silicone material may be formed onto the fabric membrane 3130 for forming the support structure 3120 that connects the seal forming structure 3100 to the plenum chamber 3200. The outer surface 3195 of the support structure 3120 substantially aligns with the outer surface 3196 (i.e., the fabric layer) of the fabric membrane 3130 to form a smooth continuous surface. The inner surface 3197 may have a thickness different from the aforementioned thickness. The silicone material overlaps a portion of the fabric membrane 3130 for forming a robust connection, but there is no unnecessary weight addition to the patient interface 3000. The silicone material may be tapered to be thinnest at the ends of the overlapping region 3199 (e.g., in the vicinity of the end 3124). The ends of the overlapping region 3199 are spaced from the nostril openings 3102 to avoid the possibility of interference with pressurized air into the patient's nostrils (e.g., causing noise). The overlapping region 4000 is substantially on the first curvature 10000 and may provide additional support for maintaining an appropriate size with respect to the first curvature 10000.

[0441] As shown in FIG. 59, some examples of patient interfaces may include a double-wall support structure 3120 coupled to a fabric membrane 3130. To connect the seal-forming structure 3100 to the plenum chamber 3200, a single wall portion of silicone material may be formed onto the fabric membrane 3130. As described above, the outer surface 3195 substantially aligns with the outer surface 3196 of the fabric membrane 3130, and the inner surface 3197 includes different thicknesses along its length. However, the overlap region 3199 may extend a different length along the inner surface 3194 of the fabric membrane 3130. Specifically, the overlap region 3199 may contact the length of the fabric membrane 3130 (which is shortened in the single wall portion support structure 3120 as described above). Alternatively, a portion of the silicone wall portion 3126 may be continuous along the length of the fabric membrane 3130, but may be spaced from the inner surface 3194. This second wall portion 3126 of the support structure 3120 may extend cantilever-style from the remainder of the lateral support region (i.e., from the end 3124). The support structure 3120 may include the second wall portion 3126 and extend along an overall overlap length similar to the support structure 3120 in the example of the single wall portion. The second wall portion 3126 may specifically be positioned in the vicinity of the apex of the first curvature 10000 for providing additional support. The second wall portion 3126 is more rigid than the fabric membrane 3130 and may assist in maintaining the shape of the first curvature 10000 when the fabric membrane 3130 contacts the patient's face. When additional force is applied, both the fabric membrane 3130 and the second wall portion 3126 may deform together.

[0442] After assembling the fabric membrane 3130 to the support structure 3120, the resulting cushion assembly 3105 may be used in the patient interface 3000. Specifically, 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 positioning the cushion assembly 3105, the patient can align the bridge portion 3104 with their nose. Specifically, the bridge portion 3104 can be oriented in the anterior / posterior direction when the cushion assembly 3105 is worn (e.g., the fabric membrane 3130 can be oriented substantially upward). When the patient moves the bridge portion 3104 into contact with their nose, the taut material of the bridge portion 3104 is pressed against the patient's nose (e.g., pressed against the patient's nose in the subnasale region and can contact the nasal septum). The bridge portion 3104 restricts the patient's nose from moving into the cavity 3101, but since the patient's nose is pressed against the taut material, tension can be applied to the surrounding region on the fabric membrane 3130. In other examples, the patient can move their face to another region of the fabric membrane 3130 under tension (e.g., when the entire region of the fabric membrane is under tension as shown in FIGS. 26 - 33).

[0444] While the patient is in contact with the bridge site 3104, the patient may also be in contact with the lateral sides 3250 and / or the corner regions 3252 of the fabric membrane. The lateral sides 3250 pressing the corner regions are disposed on a region of a third curvature 30000 near the apex of the first curvature 10000. In other words, the lateral sides 3250 and the corner regions 3252 are disposed on a surface having a saddle-shaped region and face towards the center of the cushion assembly 3105. A positive curvature may be provided between the opposing lateral sides 3250. The lateral sides 3250 and the corner regions 3252 are also disposed in the vicinity of where the fabric membrane transition moves to a negative dome curvature (i.e., that formed by the first curvature 10000) and may be understood to be 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 the corner regions 3252 contact the outer surface of the sealing portion 3130 (e.g., in the vicinity of the patient's nasal wings) and may terminate in the vicinity of the apex points of the nasal wings on either side of the patient's nose. In this orientation, the nostril openings 3102 are aligned with the patient's nostrils and can effectively deliver pressurized air to the patient's airway. Since the lateral sides 3250 and / or the corner regions 3252 are generally loose, these regions of the fabric membrane 3130 can be better formed to the diverse outer shapes of the patient's face. For example, the lateral sides 3250 and / or the corner regions 3252 can be adjusted to a shape that can conform to the region around the patient's nostrils for forming a tight seal. When the patient's nose engages with the bridge site 3104, tension (for maintaining an appropriate shape from the patient) may be generated in the lateral sides 3250 and / or the corner regions 3252.

[0445] As shown in FIG. 60, the fabric membrane 3130 may include arch portions 60000 adjacent to each of the nostril openings 3102. These arch portions 60000 are also disposed in the vicinity of the lateral sides 3250 and / or the corner regions 3252. The arch portions 60000 have a saddle region in the same direction as the first curvature 10000 (and also around 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 the opposing lateral sides 3250 and / or the 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), and the inner surfaces of each nostril contact each of the arch portions 60000. In other words, each arch portion 60000 is configured to contact the inner surface of each alar wing. Since the patient's nose also contacts the bridge portion 3104 of the fabric membrane 3130, each nostril opening 3102 surrounds the entire nostril.

[0447] As shown in FIG. 61, after each arch portion 60000 contacts the inner surface of each nostril, the arch portion 60000 reverses in the concave direction (i.e., has a positive dome curvature with respect to the inner surface of each nostril). This is similar to what occurs at the bridge portion 3104, but the curvature of the arch portions 60000 may be oriented in different directions. For example, each arch portion 60000 may move along the first axis 11000 towards each plenum chamber connector 3204. In this orientation, each nostril opening may have a generally drip shape.

[0448] When the arch portion 60000 reverses (i.e., from a negative dome curvature to a positive dome curvature), the arch portion 60000 may surround the perimeter of the nostril edge of each nostril. In other words, each arch portion 60000 surrounds the outer perimeter of each nostril. Since the fabric membrane 3130 is compliant, the arch portions 60000 can be adjusted to conform to the shape of the patient's nostril edge to form a sufficient seal to maintain the treatment pressure within the plenum chamber 3200.

[0449] After the cushion assembly 3105 is properly positioned, the patient can supply pressurized air. The fabric membrane 3130 is compliant and the exterior is slack in the initial state (as opposed to a tense state such as a bridge site), so that the seal forming structure 3100 can form a dynamic seal as the cavity 3101 is filled with pressurized air. This dynamic seal allows the cushion assembly to be slightly displaced on the patient's nose while maintaining the pressurized cavity 3101, and deliver the pressurized air to the patient airway. For example, the arch portion 60000 may be able to move slightly relative to the nostril edge without losing its own seal.

[0450] Furthermore, the third curvature 30000, the fourth curvature 40000, and / or the fifth curvature 50000 may further assist in maintaining the position of the seal formation structure 3100 and improving patient comfort. For example, the third curvature 30000 may have a saddle region for the patient and may contact the patient's subnasal region along the nasal column (e.g., via a positive curvature). The third curvature 30000 may not extend to the patient's apex point and may leave the apex point exposed. The third curvature 30000 may be disposed within the apex point region 3270 of the fabric membrane 3130. The fourth curvature 40000 may have a saddle region for the patient and may contact the patient's upper lip (e.g., via a positive curvature). Thus, the fourth curvature 40000 extends in the lateral (left / right) direction while being worn by the patient, but may extend substantially along the width of the mouth. The fifth curvature 50000 may have a negative dome curvature with respect 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 region of the patient's face and one or both may be provided on a given fabric membrane 3130. The fourth curvature 40000 and / or the fifth curvature 50000 may be disposed within the intermediate subnasal point region 3260 of the fabric membrane 3130. The fifth curvature 50000 may impart a "pillow" and / or "airbag" effect to the patient. In other words, when the negative dome curvature of the fifth curvature is used with respect to the patient's upper lip during use, additional cushioning and / or comfort may be provided to the patient due to the pressurized air that inflates the fabric membrane 3130.

[0451] The above description relates in particular to the nasal cradle, but the above description is equally applicable to the patient interfaces 9000, 21000, 23000, and 25000 described above. Further description specific to the full face cushion will be described below.

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

[0453] The assembly of the patient interfaces shown in FIGS. 22-39 is performed by placing two pieces of the fabric membrane 10135 into a molding die and molding a flexible material (e.g., silicone) onto the fabric membrane 10135 to form the patient interfaces 6000, 9000, 21000, 23000, and 25000. In these examples, the two fabric membranes 10135 are of different shapes (although a single fabric membrane 10135 can also be used) to seal specific regions on the patient's face. As described above, the first fabric membrane 10135 (i.e., the one used to form the first sealing portion 6131) has a curved shape, and the second fabric membrane 10135 includes a U-shaped or C-shaped (e.g., see FIG. 33) or a ring-shaped or circular shape (e.g., see FIG. 33-1). The fabric membranes 10135 are substantially flat (e.g., have a two-dimensional shape) before being placed in the die. After these fabric membranes 10135 are placed in the die, these two fabric membranes 10135 are spaced slightly apart from each other (e.g., via the gap 21190). In some examples, when the flexible material (e.g., silicone) is introduced into the die (e.g., the patient interface 6000) by this die, the fabric membranes 10135 are maintained in a partially flat position. In some examples, when the flexible material (e.g., silicone) is introduced into the die (e.g., the patient interfaces 9000, 21000, 23000, and 25000) by this die, curvature is introduced into the fabric membranes 10135 and the fabric membranes 10135 are held in a curved shape. When the curvature is introduced into the fabric membranes 10135 from this die, the bridge site (e.g., 9106) itself can be folded. When the flexible material is introduced into the die and cured, the two flexible fabric membranes 10135 are fixed together. After the molding process is completed, the bridge site 9106 can be crimped to remove the relaxation of the fabric membranes 10135. Alternatively, the bridge site 9106 can be crimped before placing the fabric membranes 10135 in the die. Doing so can lead to pre-deformation of the fabric membranes 10135 (e.g., the fabric membranes 10135 are deformed and then placed in the die, and additional curvature is imparted to the remaining portion of the fabric membranes 10135).The fabric membrane 10135 can be held in a tensioned position by the mold and can generally be flat along the lateral direction, so crimping of the bridge site 6106 may not be necessary. The bridge site 6106 can be placed under tension without crimping and can provide substantially the same benefits as a crimped bridge site. As described above, since the first sealing structure 6131 cannot include complex curvatures, it may be easier to manufacture the fabric membrane 10135 within the first sealing structure 6131 as compared to a first sealing structure (e.g., 9000) on another patient interface.

[0454] By using two separate pieces of the fabric membrane 10135 to form a patient interface (e.g., 9000, 21000), overlap of the fabric material 10135 can be avoided. Specifically, overlap can be a problem when attempting to impart complex curvatures onto a large piece of the fabric membrane 10135. This is because longer curvatures may become possible, and as a result, the fabric membrane 10135 itself may be more likely to fold. Since the patient interface 6000 does not include complex curvatures, the likelihood of the fabric material 10135 overlapping can also be reduced. However, when using two separate pieces of the fabric material 10135, 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, due to the patient interface 6000 being constructed by separate fabric membranes 10135, the separate pieces of the fabric membrane 10135 can be arranged in different directions to better conform to the patient's face.

[0455] One way to solve this duplication problem is to stack multiple pieces of the fabric membrane 10135 on top of each other (e.g., by creating a few millimeters of overlap with two or more fabric membranes 10135) to generate a complex curvature while reducing the stress generated in each fabric membrane 10135 (e.g., compared to a single fabric membrane 10135). However, leakage can occur in the overlapping region, which can lead to a decrease in sealing performance in the final patient interfaces 9000 and 21000, etc.

[0456] If two separate pieces of the fabric membrane 10135 are used without overlap, the length of each individual curve is shortened, reducing the likelihood that a single piece of the fabric membrane 10135 will fold on itself. Additionally, in an example where the fabric membranes 10135 overlap, the overlapping interfaces of the fabric membranes 10135 are eliminated, potentially reducing the likelihood of leakage.

[0457] Two spaced-apart pieces of the fabric membrane 10135 can be used, and the flexible material can be formed within the space between the two fabric membranes 10135. As shown, this space can be made relatively small (e.g., to reduce contact between the patient's skin and the support structures 9120 and 21120). As a result, forming this member of the patient interface (e.g., 9000, 21000) can be difficult (e.g., because it is necessary to position the fabric membrane 10135 with high precision and fill the space with the flexible material without covering the fabric layer 10133), but it is also more likely that wrinkles formed due to the complex curvature imparted to the fabric membrane 10135 will not be included in the patient interface (e.g., 9000, 21000). The same principle can apply to the patient interface 6000 even if there is no complex curvature in the first sealing portion 6131.

[0458] In this example, there is a direct trade-off between ease of manufacture and overall fabric contact. For example, the patient interface 9000 shown in FIG. 35 (or the patient interface 6000 in FIG. 33) may be easier to manufacture than the patient interface 21000 shown in FIG. 33-1 (e.g., because a liquid material may not be moldable in a small space). However, in the example shown in FIG. 35, the upper lip of the patient (e.g., in the vicinity of the philtrum) contacts a larger surface area of the support structure 9120 (i.e., a location that is not the fabric layer 10133), resulting in a lower level of patient comfort than the patient interface 21000 of FIG. 33-1.

[0459] The example of the patient interface 23000 shown in FIG. 33-2 may attempt to balance the problems 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 fabric membrane 10133 may include a U-shaped or C-shaped configuration (e.g., similar to the examples shown in FIGS. 33 and 35). The U-shaped fabric membrane 10135 includes an outer edge 23180 that forms a portion of the outer periphery of the lower sealing portion 23130b and an inner edge 23182 that forms a portion of the mouth site 23104. The first fabric membrane 10135 forms the upper sealing portion 23130a of FIG. 33-2 and is larger than the first fabric membrane 10135 that forms the upper sealing portion 21130a of FIG. 33-1, so the lower edge 23184 of the first fabric membrane 10135 may be aligned with the inner edge 23182 of the second fabric membrane 10135. In other words, in contrast to the support structure 23120, substantially the entire perimeter of the mouth site 23104 includes the fabric membrane 10135. Since the fabric membranes 10135 are separate pieces, gaps 23190 filled with a 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 in the longitudinal (e.g., left / right) direction and extend at least between the outer edge 23180 and the inner edge 23182. These gaps 23190 may be made small enough such 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 the area around their mouth). In some examples, the gaps 23190 are substantially small such that the patient cannot detect their presence.

[0460] Within the mold, the fabric membrane 10135 is arranged in the manner described above, and a flexible material is introduced into the mold to form the patient interface 23000. Since the lower edge 23184 of the first fabric membrane 10135 extends to the inner edge 23182 of the second fabric membrane, in the region that comes between the nostril opening 23103 and the mouth region 23104, the flexible material is not introduced into the mold. In other words, the fabric membrane 11035 is the only material configured to contact the upper lip in this region (e.g., relative to the philtrum). Although the flexible material can bend and move, using the combination of the fabric membrane 10135 and the flexible material can lead to a reduction in the elasticity of the patient interface 23000. For example, during the molding process, the flexible material can solidify on the inner surface of the fabric membrane 10135 (i.e., within the cavity 23001), resulting in an increase in the thickness of this region. During use, when the patient's upper lip contacts this region, it can become more difficult for the patient interface 23000 to flex, and as a result, the seal can become incomplete (i.e., can lead to leakage). By eliminating the need to provide a support region between the nostril opening 23103 and the mouth region 23104, there is no need to flow the flexible material into this region, and the increase in the thickness of the fabric membrane 10135 can also be substantially eliminated. When the fabric membrane 10135 is not substantially supported by the flexible material (e.g., as in FIG. 33-1), the fabric membrane 10135 can stretch like a patient interface entirely composed of silicone (e.g., silicone with a thickness of 0.3 mm), so the fabric membrane 10135 can achieve a sealability that is substantially the same or similar to that of the entire silicone membrane against the patient's face.

[0461] For the manufacture of this patient interface 23000, the fabric membrane 10135 can be substantially flat (e.g., two-dimensional shape) before being placed into the mold, and as a result of being placed into the mold, it can accept complex curvatures. A liquid flexible material can be added to form the three-dimensional patient interface 23000 (e.g., to maintain complex curvatures in the fabric membrane 10135 after being removed from the mold). As described above, the addition of any crimps can be performed before or after the placement of the fabric membrane 10135 into the mold.

[0462] As shown in FIG. 33-3, the patient interface 25000 can be formed using a single fabric membrane 10135 during the construction of the sealing portion 25130. In other words, one fabric membrane 10135 is used to seal around both the patient's nostrils and the patient's mouth. The sealing portion 25000 includes an upper sealing portion 25130a and a lower sealing portion 25130b. The outer periphery of the sealing portion 25130 is substantially the same as in the above-described example. However, in this example, when arranging the first and second fabric membranes 10135 at intervals and when connecting the first and second fabric membranes 10135 together, there is no need to form the support structure 25120 between the first and second fabric membranes 10135. Therefore, since it is not necessary to appropriately space the fabric membranes and appropriately fill them with a liquid-type material, manufacturing can be made easier. Further, the entire region of the patient interface 25000 that contacts the patient in the vicinity of the mouth and / or nose is constructed by the fabric layer 10133. As a result, since the support structure 25120 does not contact the patient in the vicinity of the upper lip, improvement in patient comfort can be supported.

[0463] Using the above-described crimping method, even when using a larger piece of fabric membrane 10135, it may be possible to reduce or eliminate the possibility that the single fabric membrane 10135 itself is folded (for example, as compared with the examples shown in FIGS. 33-1 and 33-2). Specifically, the crimping can reduce or eliminate the overlap in the nasal region (where more curvatures are applied).

[0464] Furthermore, there may be no significant reduction in the sealing performance of the resulting patient interface (e.g., as compared to interfaces 21000 and 23000 in FIGS. 33-1 and 33-2). The fabric membrane 10135 in FIG. 33-3 may include a fabric layer 10133 supported by an impermeable layer 10131, but the overall fabric membrane 10135 may not need to be supported (e.g., may not be supported by the flexible material of support structure 25120). The fabric membrane 10135 may be able to stretch by an amount similar to silicone alone (e.g., the impermeable layer 10131 may not significantly reduce the stretchability of the fabric membrane 10135), and thus can accommodate various contours along the patient's face (e.g., in the vicinity of the patient's nasal wings), and as a result, seal formation may be assisted.

[0465] To reduce and / or eliminate leakage during the wearing of patient interface 25000, the shape of the fabric membrane 10135 can be changed so as to better accommodate a wider range of patient faces and limit leakage (see, e.g., FIGS. 33-4 to 33-5). In one example, the modification of the fabric membrane 10135 can include reducing the radius of curvature at the upper sealing portion 25130a. Reducing the radius of curvature results in a deeper pocket or nasal radius for receiving the patient's face. For example, the portion of the upper sealing portion 25130a that receives the patient's nose can be made narrower, in which case when the patient's nose contacts the fabric layer 10133 of the sealing portion 25130, the fabric membrane 10135 becomes tighter against the patient's nose. This can be particularly useful for patients with smaller and / or narrower noses (where a sealing portion 25130 with a larger radius of curvature is too loose to fit). Since the fabric membrane 10135 can bend and deform, even patients with slightly larger noses may be able to use patient interface 25000 and obtain a tight fit (e.g., for leakage reduction).

[0466] Furthermore, even if the radius of curvature of the upper sealing portion 25130a is reduced, a similar shape can be obtained in the joining between the sealing portion 25130 and the support structure 25120. Since 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] By reducing the radius of curvature of the upper sealing portion 25130a, since the upper sealing portion 25130a and the lower sealing portion 25130b are formed from a one-piece of the same fabric film 10135, a similar shape can be obtained in the lower sealing portion 25130b. Specifically, as described above, this can lead to a reduction in the curvature at the lower end of the lower sealing portion 25130b (for example, in the region configured to contact the patient's jaw), and a similar benefit from the deeper pocket described above can also be obtained.

[0468] In some examples, the radius of curvature can be adjusted around the third axis 13000. In other words, the lateral side portions 25250 and / or the corner regions 25252 of the patient interface 25000 can be close to each other, and the patient may need to further accommodate their nose into the cushion assembly 25105 in order to contact the bridge site 25106. Furthermore, the radius of curvature around the fifth axis 15000 can be increased, thereby reducing the curvature. Increasing the radius of curvature around the fifth axis 15000 supports the maintenance of the deep curvature around the third axis 13000 because the fifth curvature 50000 does not flatten the third curvature 30000 (for example, because the third curvature 30000 and the fifth curvature 50000 are around non-parallel axes).

[0469] In some examples, the radius of curvature around the third axis can be less than approximately 40 mm. In some examples, the radius of curvature around the third axis can be less than approximately 30 mm. In some examples, the radius of curvature around the third axis can be from approximately 25 mm to approximately 15 mm. In some examples, the radius of curvature around the third axis can be approximately 20 mm. This radius of curvature can be present only in the fabric membrane 10135. By reducing the radius of curvature, the patient's nose can be fixed with a tighter fit within the sealing portion and leakage can be reduced. By reducing the radius of curvature, the space in which the patient's nose can move laterally (e.g., slide and / or displace) relative to the patient interface 25000 is reduced, so the patient is also assisted in positioning their nose more accurately relative to the patient interface 25000 (e.g., for the patient to more accurately align their nostrils with each nostril opening 25103).

[0470] Reinforcement of the sealing portion 25130 and / or the support structure 25120 can also make it possible to avoid and / or reduce leakage. As shown in FIG. 33-6, support ribs 25186 can be added within the cavity 25001 for increasing the local rigidity of the patient interface and improving the sealing property against the patient's skin. In some examples, the support ribs 25186 can be arranged and / or enlarged for increasing the local rigidity. 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 an increase in width. In some examples, the support ribs 25186 are enlarged by an increase in length.

[0471] In one example, the support rib 25186 is formed onto the patient interface 25000 within the cavity 25001, and the secondary rib 25188 is formed onto the 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 formed onto the other end of the support rib 25186. The support rib 25186 and the secondary rib 25188 may together form an L-shaped configuration. The support rib 25816 may cross 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 may be 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 the airflow passing through the nostril opening 25103. A single secondary rib 25188 may extend between the two support ribs 25186. The ends of the secondary rib 25188 may connect to the impermeable layer 10131 of the sealing portion 25130 such that the secondary rib 25186 follows an exact pattern. In other examples, the secondary rib 25188 may not extend beyond the most distal support rib 25186. In other words, the distance between the support ribs 25186 may generally be the length of the secondary rib 25188.

[0472] By providing the secondary rib 25188, the sealing of the patient interface 25000 when worn by the patient can be improved. Specifically, the rigidity of the sealing portion 25130 can be increased. For example, the portion of the sealing portion 25130 configured to contact the upper lip can have increased rigidity due to the support rib 25186 and / or the secondary rib 25188. The distance between the support ribs 25186 and the number of support ribs 25186 can affect the overall increase in rigidity. In other words, increasing the number of support ribs 25186 and / or reducing the distance between adjacent support ribs 25186 increases the rigidity of the sealing portion 25130. The secondary rib 25188 can function as a backstop and assist in limiting the compression of the support rib 25186 (e.g., by contact with the patient's face). Increasing the rigidity can assist in maintaining the shape of different curvatures and can provide an ideal fit for the patient. For example, the ribs 25186 and 25188 assist in maintaining the various radii of curvature of the sealing portion 25130, and the occurrence of wrinkles or creases is limited to limit the occurrence of leakage.

[0473] In one example (see, e.g., FIG. 33-7), the support rib 25186 is formed onto the patient interface 25000 within the cavity 25001 and has a length that is longer than the length shown in FIG. 33-6. A support rib 25186 of greater width can be formed with or without the secondary rib 25188. As the width of the support rib 25186 increases, the likelihood that the support rib 25186 will buckle when the patient wears the patient interface 25000 decreases. As a result, the rigidity of the support rib 25186 increases, and thus the likelihood that wrinkles and / or creases will form in the sealing portion 25130 decreases. Providing the secondary rib 25188 with the wider support rib 25186 can increase the rigidity of the sealing portion 25130 (more than if only one of these changes were used). However, increasing the thickness of the support rib 25186 can particularly increase the rigidity at the location where the support rib 25186 is attached to the sealing portion 25130 (i.e., a local increase in rigidity). This is in contrast to the case of the secondary rib 25188 where the rigidity increases around a larger area of the sealing portion 25130.

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

[0475] Changes in the shape of the patient interface 25000 may also enable avoidance and / or reduction of leakage (see, for example, FIGS. 33-8 and 33-9). For example, the shape and / or outer profile of the lateral side portions 25250 and / or the corner regions 25252 of the sealing portion 25130 can be adjusted so as to be conformable to the patient's face (e.g., in the vicinity of the corners of the nose or alar regions). The change in the shape of the sealing portion 25130 can be effected by a change in the shape of the support structure 25120. Since the support structure 25120 assists in determining the location of the sealing portion 25130, the shape of the support structure 25120 changes together with the shape of the sealing portion 25130.

[0476] In some examples, the first curvature 10000 can be adjusted to assist in improving the seal for the patient. Specifically, the magnitude of the first curvature 10000 can be more negative around the first axis 11000 (i.e., more negative than in the above example). As described above, the lateral side portions 25250 and / or the corner regions 25252 are disposed on the sealing portion 25130 in the vicinity of the transition between the positive curvature around the third axis 13000 (i.e., the third curvature) and the first curvature 10000. By increasing the magnitude of the first curvature 10000, the positive dome shape can be made more prominent (e.g., the curvature becomes steeper). Thereby, the width between the opposing lateral side por...

Claims

1. A patient interface for delivering an air flow continuously at a positive pressure relative to the ambient air pressure to the inlet of the patient's nostrils and in a sealed manner to the inlet of the patient's mouth, wherein the patient interface, during the patient's sleep, during the entire breathing cycle of the patient, uses a treatment pressure in the range of about 4 cmH ２ O to about 30 cmH ２ O and is configured to maintain a treatment pressure in the range of, and to improve sleep disordered breathing, the patient interface comprising: At least 6 cmH exceeding the ambient air pressure ２ A plenum chamber that at least partially forms a cavity capable of being pressurized to a treatment pressure of O, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's respiration, a plenum chamber, and A seal-forming structure including a fabric membrane constructed and arranged to form a pressure assist seal against a patient's facial region surrounding an inlet to the patient's nostrils and an inlet to the patient's mouth, the seal-forming structure comprising: a nasal portion configured to at least partially surround an inlet to the patient's nostrils, and an oral portion configured to at least partially surround an inlet to the patient's mouth, the fabric membrane having at least one hole such that airflow at the treatment pressure is delivered to at least the patient's nostrils and / or the inlet to the patient's mouth, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the cavity throughout the patient's respiratory cycle, the fabric membrane including a first portion held in a relaxed state and a second portion held in a tensioned state, the tensioned state of the second portion being configured such that the seal-forming structure includes a three-dimensional shape having a plurality of curvatures, a patient interface including the seal-forming structure.

2. The patient interface according to claim 1, wherein the at least one aperture includes a nostril opening configured to be disposed adjacent to the patient's nostrils and an oral portion configured to be disposed adjacent to the patient's mouth in use.

3. The patient interface according to claim 2, wherein a bridge portion extends across the nostril opening, dividing the nostril opening into a first aperture and a second aperture, the first aperture and the second aperture each being configured to be disposed adjacent to one of the patient's nostrils in use.

4. The patient interface according to claim 3, wherein the bridge portion is the second portion and is held in a tensioned state.

5. The patient interface according to claim 4, wherein the bridge portion is crimped using ultrasonic welding and / or an adhesive.

6. The patient interface according to any one of claims 1 to 5, wherein the first portion at least partially includes the oral portion.

7. The patient interface according to claim 6, wherein the first portion includes members of the oral portion and the nasal portion.

8. The patient interface according to any one of claims 1 to 7, wherein the seal-forming structure further includes a flexible support structure for holding the fabric membrane in a three-dimensional shape.

9. The patient interface according to claim 8, wherein the flexible support structure includes at least one support rib that engages with the oral region within the cavity of the plenum chamber.

10. The patient interface according to claim 9, wherein the flexible support structure further includes secondary ribs disposed within the cavity, and the at least one support rib extends between the secondary ribs and the oral region.

11. The patient interface according to any one of claims 1 to 10, wherein the fabric film of the seal-forming structure is curved around at least two non-parallel axes due to the tension state of the second region, thereby forming a three-dimensional shape.

12. The patient interface according to claim 11, wherein the oral region is curved around at least two non-parallel axes.

13. The patient interface according to any one of claims 1 to 12, wherein the fabric film includes a fabric layer and a silicone layer connected to the fabric layer, and the silicone layer is impermeable.

14. The patient interface according to any one of claims 1 to 13, wherein the seal-forming structure is constructed of a fabric film, and the fabric film has a first sub-member and a second sub-member spaced apart from the first sub-member.

15. The patient interface according to claim 14, wherein the seal-forming structure further includes a flexible support portion constructed of a material other than the fabric film, and the flexible support portion is disposed between the first sub-member and the second sub-member.

16. The patient interface according to claim 15, wherein the second sub-member is disposed above the first sub-member during use.

17. The patient interface according to claim 15, wherein the second sub-member is at least partially disposed between the ends of the first sub-member.

18. At least one hole portion includes a nostril opening configured to be disposed adjacent to a patient's nostril and an oral region configured to be disposed adjacent to a patient's mouth. The first sub-member completely forms around the oral region; The second sub-member completely forms around the nostril opening. The patient interface according to claim 14.

19. At least one aperture portion includes a nostril opening configured to be disposed adjacent to a patient's nostril and an oral site configured to be disposed adjacent to a patient's mouth. The periphery of the nostril opening is formed by a second sub-member; The patient interface according to claim 14, wherein the periphery of the oral site is at least partially formed by a combination of a first sub-member and a second sub-member. **Claim 20** The patient interface according to claim 14, wherein the first sub-member forms at least a part of the oral site and includes an annular shape. **Claim 21** The patient interface according to claim 14, wherein the second sub-member forms at least a part of the oral site and includes a U-shaped configuration. **Claim 22** The patient interface according to any one of claims 1 to 13, wherein a single continuous piece of the fabric film is used for constructing the oral site and the nasal site. **Claim 23** The patient interface according to claim 22, wherein the patient's nose and upper lip are configured to contact only the fabric film during use. **Claim 24** The patient interface according to any one of claims 1 to 23, further comprising a foam insert connected to the seal-forming structure and configured to contact a patient's nasal ala during use. **Claim 25** A patient interface for delivering an air flow in a sealed manner to an inlet of a patient's airway including at least the patient's nostril inlet at a continuous positive pressure with respect to the ambient air pressure, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH ２ O to about 30 cmH ２ O during the patient's sleep to improve sleep disordered breathing during the entire respiratory cycle of the patient when in use, the patient interface comprising: At least 6 cmH exceeding the ambient air pressure ２ A plenum chamber that at least partially forms a cavity capable of being pressurized to a treatment pressure of at least 6 cmH O, the plenum chamber including a plenum chamber inlet port sized and structured to receive an air flow at the treatment pressure for the patient's respiration, a plenum chamber, and A seal-forming structure, a fabric film constructed and arranged to form a pressure assist seal against an area of the patient's face surrounding an entrance to the patient's airway below the nasal bridge region of the patient's face, the fabric film having at least one aperture such that airflow at the treatment pressure is delivered at least to an entrance to the patient's nostrils, the seal-forming structure having a fabric film constructed and arranged to maintain the treatment pressure within the cavity throughout the patient's breathing cycle during use, The patient interface including a seal-forming structure, wherein the fabric film includes a first portion held in a relaxed state and a second portion held in a tensioned state, and the tensioned state of the second portion is configured such that the seal-forming structure includes a three-dimensional shape having a plurality of curvatures. **Claim 26** At least one of the hole portions includes a first hole portion and a second hole portion each configured to be disposed adjacent to one of the patient's nostrils during use, and a bridge portion is disposed between the first hole portion and the second hole portion. The patient interface according to claim 25.

27. The bridge portion is a second portion and is held in a tensioned state. The patient interface according to claim 26.

28. The bridge portion is crimped so as to be held at a higher tension than the first portion of the fabric film. The patient interface according to claim 27.

29. The area of the bridge portion is smaller than the remaining area of the fabric film. The patient interface according to claim 28.

30. The bridge portion includes a first member and a second member. The first member is substantially flat and is configured to contact the patient during use. The second member extends into the plenum chamber. The patient interface according to any one of claims 28 to 29.

31. The bridge portion is crimped using ultrasonic welding and / or an adhesive. The patient interface according to any one of claims 28 to 30.

32. When ultrasonic welding and / or an adhesive is added to the second member and is not dependent on claim 30, the patient interface according to claim 31.

33. The length of the bridge portion is directly related to the size of the first hole portion and the size of the second hole portion. The patient interface according to any one of claims 26 to 32.

34. The seal-forming structure further includes a flexible support structure for holding the fabric film in a three-dimensional shape. The patient interface according to any one of claims 28 to 31.

35. The seal-forming structure includes a single wall portion, and the end of the flexible support structure contacts the fabric film. The patient interface according to claim 34.

36. The seal-forming structure includes a pair of wall portions. The flexible support structure includes a free end. The fabric film is connected to the flexible support structure provided distally with respect to the free end, and the free end is spaced from the fabric film so that the fabric film is disposed radially outside the free end. The patient interface according to claim 34.

37. The flexible support structure is connected to the fabric film by injection molding, the patient interface according to any one of claims 34 to 36.

38. The bridge portion becomes a positioning spigot after being crimped, the patient interface according to claim 37.

39. The fabric film includes a first curvature around a first axis that intersects the first hole and the second hole, and before being crimped, the bridge portion includes a bridge curvature around the first axis in a direction opposite to the rest of the fabric film, the patient interface according to any one of claims 28 to 38.

40. A second axis extends along the bridge portion transverse to the first axis, and the fabric film includes a secondary curvature around the second axis, the patient interface according to claim 39.

41. The secondary 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, the patient interface according to claim 40.

42. The secondary curvature is configured to contact the subnasal point of the patient during use, the patient interface according to any one of claims 40 to 41.

43. A third axis extends transverse to the second axis and is distorted with respect to the first axis, and the fabric film includes a tertiary curvature around the third axis, the patient interface according to any one of claims 40 to 42.

44. The tertiary curvature is configured to contact the upper lip of the patient during use, the patient interface according to claim 43.

45. A fourth axis extends transverse to the second axis to the third axis and is parallel to the first axis, and the fabric film includes a quaternary curvature around the fourth axis, the patient interface according to any one of claims 43 to 44.

46. The quaternary curvature includes a variable radius of curvature, the patient interface according to claim 45.

47. The quaternary curvature extends into the first curvature near the edge of the fabric film, the patient interface according to any one of claims 45 to 46.

48. The portion of the first hole distal to the bridge portion is movable between a first position and a second position, the patient interface according to claim 28.

49. The patient interface according to claim 48, wherein the first position is a natural state, and the fabric membrane moves to a second position due to an external force.

50. The patient interface according to any one of claims 48 to 49, wherein a portion of the first hole extends into the plenum chamber at the second position.

51. The patient interface according to any one of claims 48 to 50, wherein the first hole includes a substantially drip shape at the second position.

52. The patient interface according to any one of claims 48 to 51, wherein at the second position, the first hole is configured to contact the periphery of an inlet to one of the patient's nostrils near the nostril edge.

53. The patient interface according to any one of claims 48 to 52, wherein a portion of the second hole distal to the bridge site is movable between the first position and the second position.

54. The patient interface according to claim 25, wherein the fabric membrane is configured to be curved around at least two non-parallel axes due to the tension state of the second portion, thereby forming a three-dimensional shape.

55. The patient interface according to any one of claims 25 to 54, wherein the fabric membrane includes a fabric layer and a silicone layer connected to the fabric layer, and the silicone layer has impermeability.

56. The patient interface according to claim 55, wherein the thickness of the silicone layer is approximately 0.5 mm.

57. The patient interface according to any one of claims 55 to 56, wherein the silicone layer is disposed within the cavity and is configured not to contact the patient's skin during use.

58. The patient interface according to any one of claims 55 to 57, wherein the silicone layer has low durometer characteristics, and the fabric membrane has a high stretch ability when connected to a flexible support structure.

59. The patient interface according to any one of claims 25 to 54, wherein the fabric membrane includes a multi-layer fabric material and a silicone layer connected to the multi-layer fabric material.

60. The multi-layer fabric material includes a first layer, a second layer, and a third layer, the silicone layer contacts only the first layer, and the third layer is configured to contact the patient's face during use. The patient interface according to claim 59.

61. The first layer and the third layer are constructed of nylon, and the second layer is constructed of spandex. The patient interface according to claim 60.

62. The thickness of the fabric film is approximately 0.35 mm to approximately 0.45 mm. The patient interface according to any one of claims 25 to 61.

63. The patient's nose and upper lip are configured to contact only the fabric film during use. The patient interface according to any one of claims 25 to 62.

64. The patient interface is a nasal cushion, a nasal cradle, an oro-nasal cushion, an ultra-small full-face mask, or a full-face mask. The patient interface according to any one of claims 25 to 63.

Images