Patient interface with seal-forming structure having varying thickness

Abstract

To provide a medical device used in the diagnosis, amelioration, treatment or prevention of respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use, and manufacturability.SOLUTION: A cushion assembly for a patient interface includes an elastomeric support portion and an elastomeric seal-forming structure supported by the elastomeric support portion that is more rigid than the elastomeric seal-forming structure. The elastomeric seal-forming structure includes a first compliant region and a second compliant region that is separated from the first compliant region by a support region that is more rigid than the first and second compliant regions. The more rigid support region extends to and is anchored by the elastomeric support portion. In addition, for every point in the rigid support region, the inner surface has a negative curvature when the outer surface has a positive curvature, and the inner surface has a positive curvature when the outer surface has a negative curvature.SELECTED DRAWING: Figure 27A

Description

Technical Field

[0001] 1 Cross - reference to related applications This application claims priority to U.S. Provisional Patent Application No. 62 / 222,503 (filing date: September 23, 2015), Published Patent Gazette / Australia 2016 / 050228 (filing date: March 24, 2016) and U.S. Provisional Patent Application No. 62 / 377,158 (filing date: August 19, 2016). The entire disclosures of these documents are incorporated herein by reference in their entireties.

[0002] 2 Background of the technology

[0003] 2.1 Field of the technology

[0004] This technology relates to one or more of the detection, diagnosis, treatment, prevention, and amelioration of respiratory - related diseases. This technology also relates to medical devices or apparatuses and their use.

Background Art

[0005] 2.2 Description of related technologies

[0006] 2.2.1 The human respiratory system and its diseases

[0007] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0008] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The main 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 form 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 zone. See the following: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0009] A range of respiratory diseases exist. Certain diseases can be characterized by specific presentations (e.g., apnea, hypopnea, and hyperpnea).

[0010] 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.

[0011] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by presentations such as closure or obstruction of the upper airway during sleep. This is due to an abnormally small upper airway during sleep and a normal deficit in muscle tone in the tongue region, a combination of the soft palate and the posterior oropharyngeal wall. 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 disease and brain damage. This syndrome is a common disease, particularly common in middle-aged overweight men, but patients may have no awareness of the symptoms. See U.S. Patent No. 4,944,310 (Sullivan).

[0012] Cheyne-Stokes respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of the patient's respiratory controller, in which alternating periods of increasing and decreasing ventilation, known as the CSR cycle, occur periodically. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to the repeated hypoxia, CSR can be harmful. In some patients, CCR is associated with repetitive sleep arousals that cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] Respiratory insufficiency is a general term for respiratory disorders, referring to the inability of the lungs 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.

[0014] Patients with respiratory insufficiency (a type of respiratory disorder) may experience abnormal shortness of breath during exercise.

[0015] Obesity hypoventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia during waking, in the absence of any other clearly identified cause of hypoventilation. Symptoms include dyspnea, headache upon waking, and excessive daytime sleepiness.

[0016] Chronic obstructive pulmonary disease (COPD) includes any of a group of lower airway diseases that have certain common characteristics. This includes an increase in resistance to the movement of air, an extended expiratory phase of breathing, and a decrease in normal elasticity in the lungs. Examples of COPD are emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0017] Neuromuscular disease (NMD) is a broad term encompassing a number of diseases and conditions that impair muscle function either directly through intrinsic muscle pathology or indirectly through neuropathy. Among NMD patients, some are characterized by progressive muscle impairment, which ultimately leads to inability to walk, confinement to a wheelchair, difficulty swallowing, reduced respiratory muscle strength, and finally death due to respiratory failure. Neuromuscular disorders can be classified into the following two categories: rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle impairment that worsens over several months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders: characterized by muscle impairment that worsens over several years and only slightly reduces the average life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include increased general debility, dysphagia, dyspnea during exertion and at rest, fatigue, drowsiness, headache upon waking, and difficulty with concentration and mood changes.

[0018] Chest wall disorders are a group of thoracic deformities that cause ineffectiveness of the connection between the respiratory muscles and the thoracic cage. These disorders are mainly characterized by restrictive disorders and share the possibility of long-term hypercapnic respiratory failure. Scoliosis and / or kyphosis may develop severe respiratory failure. Symptoms of respiratory failure include dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, headache upon waking, fatigue, reduced quality of sleep, and loss of appetite.

[0019] To treat or improve such conditions, a range of treatments are being used. Furthermore, in other respects, healthy individuals can also benefit from preventive treatment for respiratory diseases. However, these have several drawbacks.

[0020] 2.2.2 Treatment methods

[0021] A variety of therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV)) are being used for the treatment of one or more of the above respiratory diseases.

[0022] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). As its mechanism of action, for example, by pushing the soft palate and tongue to move forward or backward against the posterior oropharyngeal wall, CPAP therapy functions as an air pressure sprint, thereby avoiding upper airway closure. Since the treatment of OSA by CPAP therapy can be spontaneous, if such a patient notices one or more of the following about the device used for treatment delivery, the patient may choose not to comply with the treatment: discomfort, difficulty of use, high cost, lack of aesthetic appeal.

[0023] Non-invasive ventilation (NIV) provides ventilation assistance to the patient through the upper airway and performs part or all of the respiratory function to provide respiratory assistance to the patient and / or maintain an appropriate oxygen level in the body. The ventilation assistance is provided via a non-invasive patient interface. NIV is used in the treatment of CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0024] Invasive ventilation (IV) provides ventilation assistance to patients who are no longer able to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0025] 2.2.3 Treatment system

[0026] These treatments can be provided by a treatment system or device. Such systems and devices can also be used for diagnosis without treating the symptoms.

[0027] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0028] As another form of treatment system, there is a mandibular repositioning device.

[0029] 2.2.3.1 Patient Interface

[0030] The patient interface can be used, for example, to provide an interface to a breathing apparatus to the wearer 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 forms of treatment such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O.

[0031] Certain other mask systems may be functionally inappropriate in this field. For example, in the case of a purely decorative mask, 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.

[0032] Certain masks may be clinically unfavorable in this technology (e.g., when the mask blocks the air flow through the nose and allows only the air flow through the mouth).

[0033] In certain masks, it may be uncomfortable or impractical in this technology when the patient has to insert a part of the mask structure into the mouth and create and maintain a sealed state through the lips.

[0034] Certain masks may be impractical for use during sleep (e.g., when sleeping in bed on one's side with the head on a pillow).

[0035] In the design of patient interfaces, there are multiple challenges. 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 a respiratory therapy session.

[0036] Due to these challenges, in the case of some masks, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more of the reasons such as 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 adaptability, comfort, and patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic mask may be tolerable for their original uses, but in the case of such masks, they can be unacceptably uncomfortable for wearing over a long period (e.g., several hours). Due to such discomfort, the patient's commitment to treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0037] CPAP therapy 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 commitment.

[0038] In the case of a mask for other uses (e.g., aviators), since it may not be suitable for use in the treatment of sleep apnea, a mask designed for use in the treatment of sleep apnea may be suitable for other uses.

[0039] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0040] 2.2.3.1.1 Seal-forming portion

[0041] The patient interface may include a seal-forming portion. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the seal-forming portion can directly affect the effectiveness and comfort of the patient interface.

[0042] The patient interface can be characterized in part according to the design intent of where the seal-forming portion engages the face during use. In one form of the patient interface, the seal-forming portion may include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of the patient interface, the seal-forming portion may include a single element that surrounds both nostrils during use. Such a single element can be designed to rest, for example, on the upper lip region and nasal bridge region of the face. In one form of the patient interface, the seal-forming portion may include an element that surrounds the oral 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 portion may include a single element that surrounds both nostrils and the oral 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.

[0043] A seal-forming portion that may be effective in one area of a patient's face may be inappropriate in another area, for example, due to different shapes, structures, variabilities, and sensitivity areas of the patient's face. For example, the seal of a swimming goggle placed on a patient's forehead may be inappropriate for use on the patient's nose.

[0044] A particular seal-forming portion can be designed for mass production to fit and be comfortable and effective for a wide range of different face shapes and sizes. To form a seal, it is necessary to conform one or both of the patient's face shape and the seal-forming portion of the mass-produced patient interface to the extent of any mismatch between them.

[0045] One type of seal-forming portion 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 with the seal-forming portion engaged facing the patient's face. This seal-forming portion can include an air or fluid-filled cushion or can include a molded or formed surface of an elastic sealing element composed of an elastomer such as rubber. With this type of seal-forming portion, if the fit is inappropriate, a gap can occur between the seal-forming portion and the face, and additional force is required to press the patient interface against the face to achieve a seal.

[0046] Another type of seal-forming portion uses a thin flap seal placed around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied inside 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 portion does not match the patient's shape, creases or buckling can occur in the seal-forming portion during use, causing leakage.

[0047] Another type of seal-forming portion may include a friction fit element that is inserted into the nostrils, for example, although there are also patients who find these seal-forming portions uncomfortable.

[0048] Another form of seal-forming portion may use an adhesive portion to achieve a seal. Among patients, there are also those who always feel it inconvenient to attach or remove the adhesive portion to their face.

[0049] Regarding the technology of a range of patient interface seal-forming portions, there is a disclosure in the following patent applications assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785.

[0050] 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.

[0051] 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 MIRAGE LIBERTY® Full Face Mask. The following patent applications assigned to ResMed Limited describe embodiments of nasal pillow masks: International Patent Application WO2004 / 073,778 (in particular, describes the aspect of ResMed Limited's SWIFT® nasal pillow), US Patent Application No. 2009 / 0044808 (in particular, describes the aspect of ResMed Limited's SWIFT® LT nasal pillow); International Patent Applications WO2005 / 063,328 and WO2006 / 130,903 (in particular, describe the aspect of ResMed Limited's MIRAGE LIBERTY® Full Face Mask); International Patent Application WO2009 / 052,560 (in particular, describes the aspect of ResMed Limited's SWIFT® FX nasal pillow).

[0052] 2.2.3.1.2 Positioning and Stabilization

[0053] The seal-forming portion of a patient interface used for positive pressure air treatment is subject to the corresponding forces of air pressure that impede sealing. Therefore, various techniques are used to position the seal-forming portion and maintain the seal against the appropriate part of the face.

[0054] In one technique, an adhesive portion is used. See, for example, US Patent Application Publication US2010 / 0000534. However, when an adhesive portion is used, there may be discomfort.

[0055] In another technique, one or more straps and / or stabilization harnesses are used. In the case of many such harnesses, one or more of the following points apply: poor fit, bulky, uncomfortable and difficult to handle.

[0056] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0057] The Respiratory Pressure Therapy (RPT) device can be used for the delivery of one or more of the above-mentioned plurality of treatments, for example, by generating an air delivery flow to the airway inlet. This air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0058] Air pressure generators are known in a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical use have specific requirements that cannot be satisfied by more general air pressure generators (e.g., reliability requirements, size requirements, and weight requirements for medical devices). In addition, even devices designed for medical treatment may be defective in relation to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0059] An example of a special requirement for a specific RPT device is acoustic noise.

[0060] [Table 1]

[0061] One known RPT device used for the treatment of sleep apnea is the S9 Sleep Therapy System (manufacturer: ResMed Limited). Another example of an RPT device is a ventilator. In the case of a ventilator (e.g., the ResMed Stellar® series of adult and pediatric ventilators), it can provide assistance for invasive and non-invasive non-dependent breathing for patients for a certain range of treatments of multiple conditions (including, without limitation, NMD, OHS, and COPD).

[0062] The ResMed Elisee® 150 ventilator and the ResMed VSIII® ventilator can provide invasive and non-invasive assisted dependent breathing suitable for adult or pediatric patients for the treatment of multiple conditions. With these ventilators, volume ventilation modes and pressure ventilation modes using single or double limb circuits can be obtained. The RPT device typically includes a pressure generator (e.g., 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 at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface as described above.

[0063] The device designers can be presented with countless options. 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.

[0064] 2.2.3.3 Humidifier

[0065] If the delivery of the air flow is carried out without humidification, it can lead to drying of the airway. When a humidifier is used with the RPT device and the patient interface, humidified gas is generated, minimizing drying of the nasal mucosa and increasing the comfort of the patient airway. 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.

[0066] A range of artificial humidification devices and systems are known, but they do not meet the special requirements of medical humidifiers.

[0067] Medical humidifiers are typically used to increase the humidity and / or temperature of an air flow relative to the ambient air when a patient is asleep or at rest (e.g., in a hospital), if necessary. A medical humidifier placed at the head of a pillow may be small. A medical humidifier may be configured to perform only humidification and / or heating of the air flow delivered to the patient, and not humidification and / or heating around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air inhaled into the patient's body by breathing, but in the case of these systems, since the entire room is also humidified and / or heated, it can be uncomfortable for the occupants. Furthermore, in the case of medical humidifiers, there may be more stringent safety constraints than for industrial humidifiers.

[0068] Although a number of medical humidifiers are known, such medical humidifiers can 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.

[0069] 2.2.3.4 Data Management

[0070] 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 certain "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 the healthcare provider determines that the 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.

[0071] 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.

[0072] 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.

[0073] 2.2.3.5 Mandibular repositioning

[0074] 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.

[0075] In certain embodiments, the mandibular advancement device may include an upper splint intended to engage or fit with teeth on the maxilla or maxilla bone and a lower splint intended to engage or fit with teeth on the maxilla or 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.

[0076] 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.

[0077] There are also MRDs configured to push the mandible forward relative to the maxilla bone, and there are 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.

[0078] 2.2.3.6 Ventilation technology

[0079] Some forms of treatment systems may include a ventilation section for expelling the exhaled carbon dioxide. This ventilation section may enable the flow from the internal space (e.g., the plenum chamber) of the patient interface to the outside (e.g., the surroundings) of the patient interface.

[0080] This ventilation section may include an orifice through which gas can flow when using the mask. In the case of a number of such ventilation sections, it is noisy. In other cases, it may be blocked during use, resulting in insufficient extrusion. In the case of some ventilation sections, it may interfere with the sleep of the patient 1000 and the co - sleeper 1100, for example, due to noise or airflow concentration.

[0081] 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.

[0082] [Table 2]

[0083] [Table 3]

[0084] 2.2.4 Diagnostic systems and monitoring systems

[0085] A polysomnogram (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary diseases, and typically requires specialized 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 recording (EOG), electromyography (EMG)). For PSG of sleep disordered breathing, patients had to be observed 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. PSG is particularly unsuitable for sleep tests at home.

[0086] Clinical experts can appropriately diagnose or monitor patients 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. There may be differences in opinions among clinical experts regarding the patient's condition. Furthermore, some clinical experts may apply different criteria depending on the time.

Summary of the Invention

Problems to be Solved by the Invention

[0087] 3 Brief Description of the Technology

[0088] The present technology is related to the provision of medical devices used in the diagnosis, 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.

Means for Solving the Problems

[0089] The first aspect of the present technology is related to a device used in the diagnosis, improvement, treatment or prevention of respiratory diseases.

[0090] Another aspect of the present technology is related to a method used in the diagnosis, improvement, treatment or prevention of respiratory disorders.

[0091] One aspect of a particular form of the present technology is to provide a method and / or apparatus for improving patient compliance with respect to respiratory therapy.

[0092] One aspect of the present technology relates to a patient interface comprising: a plenum chamber that can be pressurized up to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port, the plenum chamber inlet port being sized and structured to receive an air flow at the treatment pressure for breathing by the patient, the plenum chamber; a sealing structure structured and arranged to have a shape for forming a seal with the region of the patient's face around the inlet to the patient's airway, whereby the air flow at the treatment pressure is delivered at least to the inlet to the patient's nasal cavity, the seal being formed to prevent air from exiting the plenum chamber between the sealing structure and the region of the patient's face, the sealing structure being structured and arranged to maintain the treatment pressure in the plenum chamber throughout the patient's respiratory cycle during use, the sealing structure; a positioning and stabilization structure for maintaining the sealing structure in a therapeutically effective position on the patient's head when the patient is lying in a lateral sleeping position and when the patient is lying in a supine sleeping position, the positioning and stabilization structure including a low-profile side portion and a low-profile rear portion, the positioning and stabilization structure; an exhalation ventilation structure configured to allow a continuous ventilation flow from inside the plenum chamber to the ambient while the pressure in the plenum chamber is positive relative to the ambient, the ventilation structure being configured to assist in reducing rebreathing by the patient of exhaled CO2 by the ventilation flow rate being large enough to be sufficient for both patient inhalation and patient exhalation while maintaining the treatment pressure in the plenum chamber during use. Here, the sealing structure includes a sealing surface that forms a seal against the patient's face during use, and the sealing structure includes a connecting member extending between a first inner surface region of the sealing structure on the opposite side of the sealing surface to withstand deformation of the sealing structure and a second inner surface region of the patient interface.

[0093] In an embodiment, (a) the sealing structure may include a second inner surface region that is spaced apart from the first inner surface region, (b) the plenum chamber may include a second inner surface region that is spaced apart from the first inner surface region, (c) the connector and the sealing structure may include an integral structure formed from a homogeneous material, (d) the homogeneous material may be silicone rubber, (e) the silicone rubber may be liquid silicone rubber or compression molded silicone rubber, (f) the sealing structure may include a sealing flap at the edge region, the sealing flap being shaped and arranged to at least seal the sides of the patient's nose during use, the sealing flap being thinner than the adjacent region of the sealing structure, (g) the first inner surface region may be adjacent to the sealing flap such that the connector is spaced inwardly from the sealing flap, (h) the connector may extend proximally from the sealing structure at the edge region such that the connector forms an extension of the sealing surface, (i) the connector may include an inner surface and the sealing structure may include an inner surface, (j) the inner surface of the connector is adjacent to and separated from the inner surface of the sealing structure, (k) the plenum chamber may be constructed from a transparent material, (l) the patient interface may be configured such that no part of the patient interface structure enters the oral cavity during use, (m) the sealing structure may be configured such that it does not extend into the patient's airway during use, (n) the sealing structure may be configured such that it does not extend below the ala nasi ridge region during use, and / or (o) the plenum chamber may be configured such that it does not cover the eyes during use.

[0094] Another aspect of the present technology relates to an assembly for a patient interface that includes: a plenum chamber 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, the plenum chamber inlet port being sized and structured to receive an air flow at the treatment pressure breathed by the patient; a sealing structure structured and arranged to form a seal with the region of the patient's face around the entrance to the patient's airway, whereby the air flow at the treatment pressure is delivered at least to the entrance to the patient's nasal cavity, the seal being formed to prevent air from escaping from the plenum chamber between the sealing structure and the region of the patient's face, the sealing structure being structured and arranged to maintain the treatment pressure in the plenum chamber throughout the patient's respiratory cycle during use, the sealing structure including a sealing surface that forms a seal against the patient's face during use, the sealing structure including a connection portion extending between a first inner surface region of the sealing structure on the opposite side of the sealing surface and a second inner surface region of the assembly such that the connection portion withstands deformation of the sealing structure.

[0095] In an embodiment, (a) the sealing structure may include a second inner surface region, the second inner surface region being spaced apart from the first inner surface region; (b) the plenum chamber may include a second inner surface region, the second inner surface region being spaced apart from the first inner surface region; (c) the connection portion and the sealing structure may include an integral structure formed from a homogeneous material; (d) the homogeneous material may be silicone rubber; (e) the silicone rubber may be liquid silicone rubber or compression molded silicone rubber; (f) the sealing structure may include a sealing flap in an edge region, the sealing flap being shaped and positioned to seal at least the side portions of the patient's nose during use, the sealing flap being thinner than an adjacent region of the sealing structure; (g) the first inner surface region may be disposed adjacent to the sealing flap such that the connection portion is spaced inwardly from the sealing flap; (h) the connection portion may extend proximally from the sealing structure in an edge region such that the connection portion forms an extension of the sealing surface; (i) the connection portion may include an inner surface, the sealing structure may include an inner surface, the inner surface of the connection portion being adjacent to and separated from the inner surface of the sealing structure; (j) the plenum chamber may be constructed from a transparent material; (k) the assembly may be configured such that no part of the assembly enters the oral cavity during use; (l) the sealing structure may be configured such that it does not extend into the patient's airway during use; (m) the sealing structure may be configured such that it does not extend below the tragus region during use, and / or; (n) the plenum chamber may be configured such that it does not cover the eyes during use.

[0096] One form of the present technology includes a sealing structure for sealing a user's face around the user's airway. The sealing structure includes a flap or membrane. The flap or membrane extends inwardly into the user's airway and includes an attachment structure to prevent a situation where an inner boundary line of the flap or membrane is blown outward (e.g., folded double rearward) due to internal pressurization.

[0097] In an embodiment, the attachment structure may include: one or more ribs / ties / connection portions / connection structures, a flap extending from the membrane, folded inwardly and attached to another structure to form a tube or loop, or a tube disposed below and attached to the membrane.

[0098] Another aspect of one form of the present technology is a sealing structure for a patient interface for performing a sealed delivery of an air flow to an inlet of a patient's airway including at least an inlet of the patient's nasal cavity at a positive pressure continuously with respect to the ambient air pressure. The patient interface is configured to maintain a therapeutic pressure in the range of about 3 cmH2O to about 40 cmH2O that exceeds the ambient air pressure during use throughout the patient's breathing cycle during the patient's sleep, whereby sleep disordered breathing is improved. The sealing structure includes a sealing surface configured to form a seal around the inlet to the patient's airway and a loop. The loop folds the sealing structure inwardly of the outer periphery of the sealing structure to form a substantially tubular structure such that the loop is continuous, and the loop includes a portion of the sealing surface.

[0099] In an embodiment, (a) the sealing structure further includes a sealing flap protruding into the inner circumference of the sealing structure, (b) the sealing flap is configured to form a seal against the side of the nose above the patient's nasal bone, (c) the sealing flap is configured to avoid sealing the wings, (d) a part of the sealing surface is more flexible relative to the remaining part of a part of the loop sealing surface and includes a thinner wall portion than the remaining part of the loop, (e) a part of the sealing surface includes a thicker wall portion than the remaining part of the loop, (f) the loop is arranged to contact the side wall of the nose including the wings, (g) the loop provides a continuous surface configured to maintain contact with the side of the nose above the patient's nasal bone, (h) the loop includes at least one closed end, (i) the loop folds the sealing structure inward to form a connection point on the inner surface of the sealing structure, (j) the connection point is arranged relative to the sealing surface to apply sufficient tension to the loop to neutralize outward rupture of the sealing surface when treatment pressure is applied to the inner surface of the loop, (k) the loop forms a predetermined angle at the connection point, the predetermined angle determining the tension in the loop during treatment pressure application, (l) the connection point is adjustable, (m) the connection point is a releasable connection, (n) the sealing structure further includes a second connection point, (o) the sealing surface includes a low-friction area to reduce adhesion to the patient's face, (p) the low-friction area is a matte surface, (q) the low-friction area is adapted to allow the patient's nasal side to slide freely against the sealing surface, and / or (r) the loop provides a seamless sealing surface.

[0100] Another aspect of one form of the present technology is a patient interface for delivering a stream of air in a continuous positive pressure relative to the ambient air pressure at the inlet to the patient's airway, where the inlet to the patient's airway includes at least the patient's nasal inlet. The patient interface is configured to maintain a therapeutic pressure in the range of about 3 cmH2O to about 40 cmH2O above the ambient air pressure during use throughout the patient's breathing cycle during sleep, whereby sleep disordered breathing is improved. The patient interface includes a sealing structure for sealing the patient interface against the patient's face. The sealing structure includes a sealing surface configured to form a seal around the inlet to the patient's airway and a loop that folds the sealing structure inwardly of the outer periphery of the sealing structure to form a substantially tubular structure such that the loop is continuous, and the loop includes a portion of the sealing surface. The patient interface further includes a positioning and stabilization structure for maintaining intimate contact between the sealing structure and the area around the inlet to the patient's airway while maintaining the therapeutic pressure at the inlet to the patient's airway; a plenum chamber that is pressurized at a pressure above the ambient pressure during use; and a gas exhaust ventilation portion configured to minimize rebreathing of exhaled CO2 by the patient by allowing the flow of exhaled CO2 to flow outside the patient interface.

[0101] In an embodiment, (a) the sealing flap projects into the inner periphery of the sealing structure, (b) the sealing flap is configured to form a seal adjacent to the side of the nose above the maxilla relative to the side of the nose above the nasal bone when the head portion of the patient is pressed, (c) the sealing flap is configured to avoid sealing of the wings, (d) a part of the sealing surface has higher flexibility than the remaining part of the loop, (e) a part of the sealing surface includes a thinner wall portion than the remaining part of the loop, (f) a part of the sealing surface includes a thicker wall portion than the remaining part of the loop, (g) the sealing surface includes a low friction area for reducing contact with the patient's face, (h) the low friction area is a matte surface, (i) the low friction area is adapted such that the side of the patient's nose can slide freely relative to the sealing surface, (j) the first loop defines an area of the sealing structure adapted to contact the patient's face, (k) the first site and the second site are part of the area of the sealing structure adapted to contact the patient's face, (l) the first loop is continuous, (m) the second loop is arranged in contact with or alongside the patient's nose, (n) the second loop is arranged such that a substantially tubular structure is arranged in contact with or alongside the patient's nose, (o) the substantially tubular structure is adapted to be arranged substantially parallel to the side of the patient's nose, (p) the sealing structure further includes a second one of the second loops, (g) the substantially tubular structure includes a hollow interior adapted to be in fluid communication with a pressure exceeding ambient pressure, (r) the substantially tubular structure includes two open end portions, and / or, (s) the second loop is adapted to prevent rupture of the second loop when the patient interface is internally pressurized or adjusted by the patient.

[0102] Another aspect of one 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 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 3 cmH2O to about 40 cmH2O, which is higher than the ambient air pressure, throughout the patient's breathing cycle during sleep when in use, so as to improve sleep-disordered breathing. The patient interface includes a sealing structure for sealing the patient interface against the patient's face. The sealing structure includes a face contact portion adapted to contact around the inlet to the patient's airway and a first substantially cylindrical region having at least a continuous circumference. A part of the cylindrical region includes a part of the face contact portion. The patient interface includes a positioning and stabilization structure for maintaining a sealed contact between the sealing structure and the region around the inlet to the patient's airway while maintaining the therapeutic pressure at the inlet to the patient's airway; a plenum chamber pressurized at a pressure exceeding the ambient pressure during use; and a gas discharge ventilation portion configured to minimize rebreathing of the exhaled CO2 by the patient by allowing the flow of the exhaled CO2 by the patient to flow outside the patient interface.

[0103] In an embodiment, (a) the sealed structure includes an unrestricted edge adjacent to an end of a first substantially cylindrical region, (b) the sealed structure includes an unrestricted edge around the entire perimeter of an inlet to a patient's airway except for the first substantially cylindrical region, (c) the site of the face contact site forms a convex surface adapted to contact the patient's face, (d) the first substantially cylindrical region is arranged in contact with or alongside a patient's ala, (e) the first substantially cylindrical region is arranged substantially parallel to a patient's ala, (f) the patient interface further includes a second one of the cylindrical regions, (g) the cylindrical region includes a second substantially cylindrical region having a second continuous circumference, and a portion of the second cylindrical region includes a second site of the face contact site, (h) the first substantially cylindrical region includes a hollow interior adapted to be in fluid communication with a pressure exceeding ambient pressure, (i) the first substantially cylindrical region includes two open ends, and / or (j) the first substantially cylindrical region is adapted to prevent rupture of the face contact portion when the patient interface is internally pressurized or adjusted by a patient.

[0104] Another aspect of one 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 positive pressure continuously with respect to ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 3 cmH2O to about 40 cmH2O, which is higher than the ambient air pressure, throughout the patient's breathing cycle during sleep, such that sleep disordered breathing is improved. The patient interface is a sealed structure including a material folded double to form a continuous tubular shape, configured such that only a portion of the circumference of the tubular shape contacts the patient's face; a positioning and stabilization structure for maintaining a sealed contact between the sealed structure and the nasal cavity around the inlet to the patient's airway while maintaining the therapeutic pressure at the inlet to the patient's airway; a plenum chamber pressurized at a pressure exceeding the ambient pressure during use; and a gas exhaust vent configured to minimize rebreathing of exhaled CO2 by the patient by allowing the patient's exhaled CO2 to flow outside the patient interface, wherein the interior of the tubular shape is adapted to be in fluid communication with a pressure exceeding the ambient pressure.

[0105] In an embodiment, (a) the continuous tubular shape has an inner surface of the tube and an outer surface of the tube, the inner surface of the tube is adapted to be exposed to a pressure exceeding the ambient pressure during use, a first portion of the outer surface of the tube is adapted to be exposed to the ambient pressure during use, and a second portion of the outer surface of the tube is adapted to be exposed to a pressure exceeding the ambient pressure during use, (b) the sealed structure further includes a surface that contacts the periphery of the patient's airway, and the continuous tubular shape portion is a part of the surface, (c) the continuous tubular shape is open at least at one end, (d) the continuous tubular shape is open at two ends, (e) the continuous tubular shape is adapted to align with the patient's wings, (f) the continuous tubular shape is adapted to contact the patient's wings, (g) the material is folded to form a second continuous tubular shape, wherein only a part of the circumference of the second continuous tubular shape is configured to contact the patient's face, (h) the continuous tubular shape is adapted to come on opposite sides of the patient's nose, and / or (i) the continuous tubular shape is adapted to prevent a situation where the material ruptures when the patient interface is internally pressurized or adjusted by the patient.

[0106] Another aspect of one form of the present technology is 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 positive pressure continuously with respect to the ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 3 cmH2O to about 40 cmH2O, which is higher than the ambient air pressure, throughout the patient's breathing cycle during sleep when in use, such that sleep disordered breathing is improved. The patient interface includes a sealing structure for sealing the patient interface to the patient's face. The sealing structure includes a first face contact portion having an edge that is not connected at the inner boundary line of the sealing structure, and a second face contact portion that is part of a tubular structure, and the first face contact portion and the second face contact portion each form a continuous membrane configured to contact the patient's face around the inlet to the patient's airway. The patient interface includes a positioning and stabilization structure for maintaining a sealed contact between the sealing structure and the area around the inlet to the patient's airway while maintaining the therapeutic pressure at the inlet to the patient's airway; a plenum chamber that is pressurized at a pressure exceeding the ambient pressure during use; and a gas discharge ventilation portion configured to minimize rebreathing of the exhaled CO2 by the patient by allowing the flow of the exhaled CO2 by the patient to flow outside the patient interface.

[0107] In an embodiment, (a) the patient interface further includes a plurality of second face contact portions, (b) the second face contact portions are adapted to contact the patient's face adjacent to or on the patient's wings, and / or (c) the tubular structure is adapted to prevent rupture of the continuous membrane when the patient interface is internally pressurized or adjusted by the patient.

[0108] Another aspect of one 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 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 3 cmH2O to about 40 cmH2O higher than the ambient air pressure throughout the patient's breathing cycle during the patient's sleep when in use, such that sleep disordered breathing is improved. The patient interface includes a sealing structure for sealing the patient interface to the patient's face. The sealing structure includes a sealing membrane and a flap. This flap is attached to the sealing membrane at a first end and to another structure at a second end to prevent a situation where the sealing membrane ruptures outwardly due to the therapeutic pressure. The patient interface includes a positioning and stabilization structure for maintaining a sealed contact between the sealing structure and the area around the inlet to the patient's airway while maintaining the therapeutic pressure at the inlet to the patient's airway; a plenum chamber that is pressurized at a pressure exceeding the ambient pressure during use; and a gas exhaust vent configured to minimize re-breathing of exhaled CO2 by the patient by allowing the flow of the patient's exhaled CO2 to flow outside the patient interface.

[0109] In an embodiment, (a) the sealing membrane and the flap form part of a tubular structure and / or (b) the sealing membrane is adapted to contact the entire perimeter around the inlet to the patient's airway and the flap is provided only to a part of the perimeter.

[0110] Another aspect of one form of the present technology is a patient interface for delivering an airflow in a sealed manner to an inlet of 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 3 cmH2O to about 40 cmH2O, which is higher than the ambient air pressure, throughout the patient's breathing cycle during sleep of the patient during use, so that sleep disordered breathing is improved. The patient interface includes a sealing structure for sealing the patient interface to the patient's face. The sealing structure includes a sealing membrane adapted to contact the patient's face around the inlet to the patient's airway and a cylindrical region attached to the underside of the sealing membrane. The patient interface includes a positioning and stabilization structure for maintaining a sealed contact between the sealing structure and the region around the inlet to the patient's airway while maintaining the therapeutic pressure at the inlet to the patient's airway; a plenum chamber pressurized at a pressure exceeding the ambient pressure during use; and a gas discharge ventilation section configured to minimize rebreathing of exhaled CO2 by the patient by allowing the flow of exhaled CO2 by the patient to flow outside the patient interface.

[0111] In an embodiment, (a) the cylindrical region is disposed adjacent to the patient's ala, (b) the cylindrical region includes an axis substantially parallel to the patient's ala, (c) the cylindrical region is adapted to prevent a situation where the sealing membrane is blown away in a direction away from the inlet to the patient's airway when the plenum chamber is pressurized at a pressure exceeding the ambient pressure, and / or (d) the sealing membrane includes a non-connected edge throughout the perimeter of the inlet to the patient's airway.

[0112] Another aspect of one form of the present technology is 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 the ambient air pressure. This patient interface is configured to maintain a therapeutic pressure in the range of about 3 cmH2O to about 40 cmH2O, which is higher than the ambient air pressure, throughout the patient's breathing cycle during sleep when in use, so as to improve sleep disordered breathing. The patient interface includes a sealing structure for sealing the patient interface against the patient's face. The sealing structure includes a sealing membrane having an inner surface and an outer surface adapted to contact the patient's face around the inlet to the patient's airway, and ribs attached to the lower side of the inner surface such that the ribs withstand deformation of the sealing membrane when pressure is applied to the inner surface. The patient interface further includes a positioning and stabilization structure for maintaining a sealed contact between the sealing structure and the area around the inlet to the patient's airway while maintaining the therapeutic pressure at the inlet to the patient's airway; a plenum chamber pressurized at a pressure exceeding the ambient pressure during use; and a gas discharge ventilation portion configured to minimize rebreathing of the exhaled CO2 by the patient by allowing the flow of the exhaled CO2 by the patient to flow outside the patient interface.

[0113] In an embodiment, (a) the outer surface includes a convex portion, (b) the inner surface has a concave portion, (c) the concave portion and the convex portion are disposed directly opposite each other on the outer surface and the inner surface, respectively, and the ribs are attached to the inner surface at the concave portion, (d) the ribs are easily crushed by the force applied to the patient interface when the patient holds the patient interface, (e) the patient interface further includes a plurality of ribs, (f) the ribs are adapted to be adjacent to the patient's nose, (g) the ribs are adapted to prevent rupture of the sealing membrane when the patient interface is internally pressurized or adjusted by the patient, and / or (h) the ribs are substantially perpendicular to the inner surface.

[0114] Another aspect of one form of the present technology relates to a cushion assembly for 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 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, which is higher than the ambient air pressure, throughout the patient's breathing cycle during sleep, such that sleep-disordered breathing is improved. The cushion assembly includes an elastomeric support portion. The cushion assembly also includes an elastomeric seal-forming structure. The elastomeric seal-forming structure is supported by the elastomeric support portion and is shaped to be bisected by a sagittal plane. The sagittal plane includes tangents to the elastomeric seal-forming structure at an upper contact point and a lower contact point. The elastomeric support portion is more rigid than the elastomeric seal-forming structure. Additionally, the elastomeric support portion and the elastomeric seal-forming structure define a chamber. The elastomeric seal-forming structure may include an inner surface that forms a boundary of the chamber and may include an outer surface on the opposite side of the inner surface. The elastomeric seal-forming structure may also include a first compliant region including an upper contact point and a second compliant region separated from the first compliant region by a support region. This support region is more rigid than the first compliant region and the second compliant region. The highly rigid support region may extend to or be anchored to the elastomeric support portion. Additionally, at each point within the rigid support region, when the outer surface has a positive curvature, the inner surface has a negative curvature, and when the outer surface has a negative curvature, the inner surface has a positive curvature.

[0115] Another aspect of one form of the present technology relates to a cushion assembly for 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, which is higher than the ambient air pressure, throughout the patient's breathing cycle during sleep, such that sleep disordered breathing is improved. The cushion assembly may include an elastomeric support portion and an elastomeric seal-forming structure. The elastomeric seal-forming structure may be supported by the elastomeric support portion and may be shaped to be bisected by a sagittal plane. The sagittal plane includes a tangent to the elastomeric seal-forming structure at an upper contact point and a lower contact point, and the elastomeric support portion is more rigid than the elastomeric seal-forming structure. The elastomeric seal-forming structure may include a first compliant region including the upper contact point and a second compliant region separated from the first compliant region by a spring region. The spring region has an elastomeric wall thickness that is greater than that of the first compliant region and the second compliant region. The spring region may be tapered such that the elastomeric wall thickness increases as it approaches the support portion. Additionally, the spring region may have a curvature that extends from the seal-forming structure to the support portion.

[0116] Another aspect of one form of the present technology relates to a cushion assembly for 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 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 throughout the patient's breathing cycle during sleep when in use, such that sleep disordered breathing is improved. The cushion assembly may include an elastomeric seal-forming structure shaped to be bisected by a sagittal plane. The sagittal plane has a tangent to the elastomeric seal-forming structure at an upper contact point and a lower contact point. The saddle-shaped upper region of the elastomeric seal-forming structure may straddle the sagittal plane and may include an upper contact point. The elastomeric seal-forming structure may move from a saddle-shaped region to a hemispherical upper region offset from the sagittal plane within a cylindrical upper region. The elastomeric wall thickness of the elastomeric seal-forming structure may be thicker within the cylindrical upper region than within the saddle-shaped upper region and the hemispherical upper region. Another aspect of one form of the present technology relates to a cushion assembly for 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 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 throughout the patient's breathing cycle during sleep when in use, such that sleep disordered breathing is improved. The cushion assembly may include an elastomeric seal-forming structure having an inner surface defining at least a portion of the boundary of the chamber, the elastomeric seal-forming structure having a rear central opening and a front central opening on the side opposite the rear central opening, and the elastomeric seal-forming structure including a plurality of closed paths coaxial with the rear central opening. The elastomeric wall thickness of the elastomeric seal-forming structure may vary along one of the plurality of closed paths. The inner surface of the thicker portion of the elastomeric wall along one of the plurality of closed paths may be curved in the direction of an open path extending from the rear central opening to the front central opening. The plurality of closed paths includes an innermost path.Along the innermost path, the elastomer wall thickness of the elastomer seal forming structure is invariant.

[0117] Another aspect of one form of the present technology relates to a cushion assembly for 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 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 the ambient air pressure throughout the patient's breathing cycle during sleep when in use, such that sleep disordered breathing is improved. The cushion assembly can include an elastomeric support portion and an elastomer seal forming structure. The elastomer seal forming structure can be supported by the elastomeric support portion, and the elastomeric support portion is more rigid than the elastomer seal forming structure. The elastomer seal forming structure can include a bridge region configured to seal the patient's nasal bridge when the cushion is attached to the patient's face, and a compliant region configured to seal the sides of the patient's nose when the cushion is attached to the patient's face. The elastomer seal forming structure can also include a support region separating the bridge surface from the compliant region, and the support region is thicker than the bridge region and the compliant region. The support region can be tapered such that the elastomer wall thickness of the support region increases as it approaches the support portion.

[0118] Another aspect of one form of the present technology relates to a cushion assembly for 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, which is higher than the ambient air pressure, throughout the patient's breathing cycle during sleep, and is configured to improve sleep apnea. The cushion assembly may include an elastomeric seal-forming structure having an outer surface configured to seal the patient's face when the cushion is attached to the patient's face, and the elastomeric seal-forming structure has an inner surface facing the outer surface and defining at least a portion of the chamber. There may be a central opening within the seal-forming structure configured to receive at least a portion of the patient's nose when the cushion is attached to the patient's face. The seal-forming structure may include a plurality of closed paths coaxial with the central opening. The elastomeric wall thickness of the elastomeric seal-forming structure may vary along one of the plurality of closed paths. A thicker portion of the elastomeric wall along one of the plurality of closed paths may have an inner surface facing the chamber. This inner surface is curved in the direction of the open path extending from the rear central opening to the front central opening. The plurality of closed paths may include an innermost path. Along the innermost path, the elastomeric wall thickness of the elastomeric seal-forming structure is invariant.

[0119] Another aspect of one form of the present technology relates to a cushion assembly for a patient interface for delivering a gas flow in a sealed manner to an inlet to a patient's airway, including at least the patient's nostril inlet, at a positive pressure continuously with respect 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, which is higher than the ambient air pressure, throughout the patient's breathing cycle during sleep when in use, such that sleep disordered breathing is improved. The cushion includes an elastomeric support portion and an elastomeric seal-forming structure that is more flexible than the elastomeric support portion. The elastomeric seal-forming structure may include a tubular structure with a continuous circumference. The cushion may also include a plenum chamber defined by the elastomeric support portion and the elastomeric seal-forming structure. The plenum chamber may be configured to receive positive pressure gas. Additionally, the tubular structure and the chamber may be bounded by a common inner surface of the elastomeric seal-forming structure.

[0120] Another aspect of one form of the present technology relates to a cushion assembly for a patient interface for delivering a gas flow in a sealed manner to an inlet to a patient's airway, including at least the patient's nostril inlets, at a positive pressure continuously with respect 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, which is higher than the ambient air pressure, throughout the patient's breathing cycle during sleep when in use, such that sleep disordered breathing is improved. The cushion assembly includes an elastomeric support portion and an elastomeric seal-forming structure that is more flexible than the elastomeric support portion. The elastomeric seal-forming structure is supported by the elastomeric support portion. Additionally, the elastomeric seal-forming structure may include a connection portion that extends from the inner surface of the elastomeric seal-forming structure to the inner surface of the elastomeric support portion. The cushion may also include a plenum chamber configured to receive positive pressure air. The plenum chamber may be defined by the elastomeric support portion and the elastomeric seal-forming portion. The connection portion may be arranged to withstand deformation of the seal-forming structure to prevent a situation where the sealing surface of the seal-forming structure is deformed outwardly by the pressurized gas in the plenum chamber.

[0121] Another aspect of one form of the present technology relates to a cushion assembly for a patient interface for delivering a gas flow in a sealed manner to an inlet to a patient's airway including at least the patient's nostril inlet at a positive pressure continuously 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 throughout the patient's breathing cycle during sleep, such that sleep disordered breathing is improved. The cushion assembly includes an elastomeric support portion and an elastomeric seal-forming structure that is more flexible than the elastomeric support portion. The elastomeric seal-forming structure extends from a first end to a second end, and the first end is fixed to the elastomeric support portion. The second end of the elastomeric seal-forming structure is a free end and is not attached to any structure except at the point where the elastomeric seal-forming structure is looped, and the second end is fixed at the location where the elastomeric seal-forming structure is looped.

[0122] Another aspect of one form of the present technology relates to a cushion assembly for a patient interface for delivering a gas flow in a sealed manner to an inlet to a patient's airway including at least the patient's nostril inlet at a positive pressure continuously 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 throughout the patient's breathing cycle during sleep, such that sleep disordered breathing is improved. The cushion assembly includes an elastomeric support portion and an elastomeric seal-forming structure that is more flexible than the elastomeric support portion. The plenum chamber is configured to receive positive pressure air. In addition, the plenum chamber is defined by the elastomeric support portion and the elastomeric seal-forming portion. The first cross-sectional shape of the elastomeric seal-forming structure is a closed loop, and the second cross-sectional shape of the elastomeric seal-forming structure is open.

[0123] 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 shape of the intended wearer.

[0124] One aspect of one form of the present technology is a method for manufacturing a device.

[0125] One aspect of a specific 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.

[0126] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., around their home).

[0127] One aspect of one form of the present technology is a patient interface that can be cleaned, for example, with soap 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 water in the patient's home, and no special cleaning equipment is required.

[0128] The methods, systems, devices, and apparatuses described herein may enable improvement of 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). Furthermore, the described methods, systems, devices, and apparatuses may enable improvement in the technical field of automatic management, monitoring, and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0129] Of course, some of the above aspects may form sub-aspects of the present technology. Also, various combinations of various ones of the sub-aspects and / or aspects can be made, which may also constitute further aspects or sub-aspects of the present technology.

[0130] Other features of the present technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

Brief Description of the Drawings

[0131] 4 Brief Description of the Drawings

[0132] This technology is illustrated as a non-limiting example in the accompanying drawings. In the drawings, like reference numerals include the following like elements:

[0133] 4.1 Treatment System

[0134]

Figure 1A

Figure 1B

Figure 1C

[0135] 4.2 Respiratory System and Facial Anatomical Structure

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[0136] 4.3 Patient Interface

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[0137] 4.4 RPT Device

Figure 3U

[0138] 4.5 Humidifier

Figure 3V

Figure 3W

[0139] 4.6 Seal Forming Structure and Patient Interface

Figure 4

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DETAILED DESCRIPTION OF THE INVENTION

[0140] 5 DETAILED DESCRIPTION OF THE EMBODIMENTS OF THE PRESENT TECHNOLOGY

[0141] Before further describing the present technology in detail, it should be understood that the present technology is not limited to the specific embodiments that may be described herein. It should also be understood that the terms used in the present disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0142] The following description is provided in relation to various embodiments that may share one or more common characteristics and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or other embodiments. Additionally, any single feature or combination of features in any of these embodiments may constitute a further embodiment.

[0143] 5.1 Treatment method

[0144] In one form, the present technology includes a method for treating a respiratory disease. The method includes the step of applying positive pressure to the entrance of the airway of patient 1000.

[0145] In certain embodiments of the present technology, an air supply at positive pressure is provided to the patient's nasal passage via one or both of the nostrils.

[0146] In certain embodiments of the present technology, mouth breathing is restricted, limited, or prevented.

[0147] 5.2 Treatment system

[0148] In one form, the present technology includes an apparatus or device for the treatment of a respiratory disorder. The apparatus or device may include an RPT device 4000 that supplies pressurized air to patient 1000 via an air circuit 4170 to a patient interface 3000.

[0149] 5.3 Patient interface

[0150] 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 vent hole 3400, a form of connection port 3600 for connection to an 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 entrance of the patient's airway so as to facilitate the supply of air at positive pressure to the airway.

[0151] According to the inventors' findings, if the patient interface 3000 cannot deliver the lowest level of positive pressure comfortably to the airway, there is a possibility that the treatment will be ineffective.

[0152] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH20 relative to the surroundings.

[0153] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH20 relative to the surroundings.

[0154] The patient interface 3000 according to one embodiment of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH20 relative to the surroundings.

[0155] 5.3.1 Seal formation structure

[0156] In one embodiment of the present technology, the seal formation structure 3100 provides a seal formation surface and may further provide a cushioning function.

[0157] The seal formation structure 3100 according to the present technology may be composed of a soft, flexible and elastic material (for example, silicone).

[0158] In one embodiment, the non-invasive patient interface 3000 includes a seal formation portion that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face during use.

[0159] In one embodiment, the non-invasive patient interface 3000 includes a seal formation portion that forms a seal on the jaw region of the patient's face during use.

[0160] In a particular embodiment of the present technology, a system including more than one seal formation structure 3100 is provided. Each seal formation structure 3100 is configured to correspond to a different size and / or shape range. For example, the system may 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.

[0161] In a particular form of the present technology, the seal-forming structure 3100 is composed of a biocompatible material (e.g., silicone rubber).

[0162] FIG. 4 is a perspective view of the seal-forming structure 3100 separated from the rest of the patient interface 3000. The seal-forming structure includes a sealing surface 3105 configured to form a seal around the patient's airway. The seal can be formed around the patient's nose or around the patient's nose and mouth.

[0163] The seal-forming structure 3100 includes a connecting member, connection portion, or loop 3110 that folds the seal structure 3100 inwardly (e.g., toward the patient's face during use) at the outer periphery 3115 of the seal structure 3100. The outer periphery 3115 can generally be defined as a wall that supports the sealing surface 3105 and / or is formed continuously with the sealing surface 3105. In this way, the connecting member 3110 can form a substantially tubular structure 3120 such that the connecting member 3110 forms a continuous structure (e.g., a continuous circumference) with the sealing surface 3105 and the outer periphery 3115. Thus, the connecting member 3110 can include a portion of the sealing surface 3105, a portion of the outer periphery 3115, and a portion that is neither the sealing surface 3105 nor the outer periphery 3115. The portion that is neither the sealing surface 3105 nor the outer periphery 3115 can take the form of a flap or sheet and is attached to the sealing surface at one end or is continuous with the sealing surface and attached to the outer periphery 3115 at the other end or is continuous with the outer periphery 3115. The connecting member 3110 can be disposed above the nasal bone or at any position therebetween along the patient's nose (e.g., along the ala). Two connecting members 3110 can be provided on opposite sides of the patient's nose. The connecting member 3110 can be open internally, including one or both ends, such that the connecting member 3110 is internally pressurized (e.g., fluidly communicated) by the patient's treatment pressure during use.

[0164] In one form of the present technology, the connecting member 3110 can extend only partially around the seal-forming structure 3100.

[0165] In one form, the connector 3110 and the seal-forming structure 3100 do not form a closed pressurizable structure (e.g., a bladder), such that the space between the connector 3110 and the seal-forming structure 3100 is open to the pressure inside the patient interface 3000.

[0166] In one form, the seal-forming structure 3100 has an edge and the connector 3110 holds the edge so as to prevent rupture at the edge.

[0167] The region of the sealing surface 3105 other than the connector 3110 may include a sealing flap 3125 that projects inwardly towards the inner circumference 3100 of the sealing structure. The sealing flap 3125 may have a free edge at or near the inner radial portion of the sealing surface 3105. The sealing flap 3125 may include a portion 3125a configured to form a seal against the side of the nose above the patient's nasal bone. The sealing flap 3125 may be configured to avoid sealing against the ala (e.g., by being spaced radially outwardly sufficiently away from the ala), thereby avoiding or minimizing contact with the ala.

[0168] FIG. 5 is a perspective view of the seal-forming structure 3100 on the substantially opposite side to FIG. 4. The substantially tubular structure 3120 may be more readily apparent from this figure. FIG. 5A shows the connector 3110 with a closed end 3111. This figure also shows the seal-forming structure 3100 without a cushion on the lower side, such that the seal-forming structure 3100 may be referred to as a single-layer cushion.

[0169] FIG. 6 is a plan view of the seal-forming structure 3100 and functions as a basis for the two cross-sectional views shown in FIGS. 7 and 8.

[0170] FIG. 7 is a cross-sectional view taken through the connecting member 3110. The substantially tubular structure 3120 can be more readily distinguished from this figure. The connecting member 3110 includes a relatively thick portion 3130 and a relatively thin portion 3135. The relatively thick portion 3130 can be 1 mm to 2 mm thick, or can be 1.3 mm to 1.7 mm thick, or can be about 1.5 mm thick. The relatively thin portion 3135 can be 0.2 mm to 0.8 mm thick, or can be 0.4 mm to 0.6 mm thick, or can be about 0.5 mm thick. Alternatively, the thickness of the relatively thick portion 3130 can be about 2.5 to 5 times the thickness of the relatively thin portion 3135, or can be about 2.8 to 3.3 times the thickness of the relatively thin portion 3135, or can be 3 times the thickness of the relatively thin portion 3135. A state is illustrated in which the relatively thick portion 3130 includes most of the outer periphery 3115 and the sealing surface 3105 in the connecting member 3110. The relatively thin portion 3135 folds the sealing structure inward at the hinge structure 3140 or a connection point 3165 in the vicinity thereof, and reconnects to the seal forming structure 3100. The hinge structure 3140 is illustrated as a locally relatively thin strip or line. Therefore, it can be preferably bent or deflected at a predetermined position, so that flexibility for conforming to the patient's face is obtained in the seal forming structure 3100. The relatively thick portion 3130 provides sufficient elasticity for providing an effective seal against the patient's face. The relatively thin portion 3135 can provide resistance to prevent the sealing surface 3105 from rupturing under pressure while preventing the rigidity of the sealing surface 3105 from becoming too high when forming an effective seal. Alternatively, the thicknesses of the relatively thick portion 3130 and the relatively thin portion 3135 can be the reverse of the content shown in FIG. 7. Alternatively, the relatively thin portion 3135 may be extended to include the sealing surface 3105. Any combination of thicknesses can be used to achieve the desired combination of sealing ability and burst resistance.

[0171] The connection point 3165 can be determined based on a desired force applied from the joining member 3110 or the desired elasticity of the joining member 3110. For example, as shown in FIG. 7A, the angle 3170 formed by the relatively thin portion 3135 can vary. As the angle 3170 varies, the tension in the relatively thin portion 3135 also varies. Therefore, the angle 3170 can be optimized for rupture prevention and / or patient comfort.

[0172] The angle 3170 can be predetermined in several ways. For example, if the seal-forming structure 3100 is a single molded piece, the angle 3170 is determined by the way in which the seal-forming structure 3100 is formed. Different angles can be achieved with different molds. Alternatively, the relatively thin portion 3135 may be manufactured in a non-connected state, whereby the connection point 3165 is formed in a subsequent assembly step. The connection point 3165 can be a mechanical connection or an adhesive. If an adhesive is used, the connection point 3165 can vary continuously within an acceptable attachment. Alternatively, a mechanical attachment may be used. FIGS. 7B-7I show exemplary mechanical attachments. In FIGS. 7B-7E, the connection point 3165 is keyed so that different angles can be achieved at a single connection point 3165. FIGS. 7B and 7C show a first connection orientation of the keyed connection, and FIGS. 7D and 7E show a second connection orientation of the keyed connection. In FIGS. 7F-7I, a plurality of separate connection points 3165 are illustrated. The selected connection point 3165 determines the angle 3170. FIGS. 7F and 7G show a first separate connection of the separate connection points, and FIGS. 7H and 7I show a second separate connection of the separate connection points. The specific geometries shown in FIGS. 7B-7I are exemplary only and should not be considered limiting. Other keyed or separate connection geometries may also be used.

[0173] As can be understood from FIG. 7, the joining member 3110 can be arranged to contact the side wall of the nose including the wings. The joining member 3110 can also provide a continuous surface for maintaining contact with the side of the nose above the patient's nasal bone.

[0174] FIG. 8A shows a cross-sectional view taken through the vertical plane in FIG. 6. As best understood from FIG. 8, the connecting member 3110 is attached to the wall forming the outer periphery 3115 at the attachment site 3145. As shown, the attachment site 3145 is a continuous portion of the connecting member 3110 and can be achieved by molding the seal forming structure 3100 in one piece. However, the attachment site 3145 can also be achieved by any other convenient method (e.g., by fastening the free end of the connecting member 3110 using some form of mechanical or chemical fastening such as adhesion). The attachment site 3145 can be selected along the entire length of the connecting member 3110 such that when pressure (e.g., treatment pressure) acts on the inner surface of the connecting member 3110 and the seal forming structure 3100 is pulled away from the patient's face and / or when sufficient headgear tension exists, sufficient tension is provided to the connecting member 3110 to neutralize the rupture of the sealing surface 3105.

[0175] Part or all of the sealing surface 3105 can be a (relatively) low friction region. This can be achieved by providing a so-called matte surface. With the low friction region, the sealing surface can adhere closer to the patient's face than it would without the low friction region. The low friction region can be provided as part of the connecting member 3110 that allows the side(s) of the patient's nose to slide freely along the sealing surface 3105 and / or the connecting member 3110.

[0176] FIGS. 8A - 8G also show various cross-sections of FIG. 6. In the figures, the intersections of the cross-sections indicate that the seal forming structure 3100 includes various saddles and hemispheres. For the sake of brevity, in this specification, the intersections of the various cross-sections are indicated by two-letter combinations. For example, the intersection of the cross-section taken along line 8A - 8A and the cross-section taken along line 8B - 8B is called intersection AB.

[0177] Intersection AB is taken in a first dome region configured to contact the nasal sill of the patient below the patient's septum. Intersection AC is taken in a first saddle region configured to contact the nasal sill of the patient at a position below intersection AB. Intersection AD is taken in a second saddle region configured to contact the lower lip and / or chin of the patient. Intersection EF is taken in a second dome region configured to contact the patient outside and adjacent to the oral cavity of the patient in the vicinity of the commissure point. Intersection EG is taken in a third saddle region configured to contact the patient's cheek adjacent to the patient's alar. In relation to each other, the first dome region has a relatively large curvature along both cross-sections, and the second hemispherical region has a relatively small curvature along both cross-sections. The first saddle region has a relatively large curvature along both cross-sections, the third saddle region has a relatively small curvature along line 8E-8E, and a relatively large curvature along line 8G-8G. The second saddle region has a curvature between the first saddle region and the third saddle region along line 8D-8D, and line 8A-8A is the same as that along line 8G-8G.

[0178] Figure 9 shows a further aspect of the present technique. For example, instead of making the connecting member 3110 continuous with the sealing surface 3105, Figure 9 shows the connecting member 3110 disposed below the sealing surface 3105. The connecting member 3110 is mainly shown as a dashed line. This configuration can be achieved by attaching or forming a strip or a tube of material below the sealing surface 3105. The lower connecting member 3110 can be more readily apparent from Figure 10.

[0179] Figure 9 also shows the flap 3150. The flap 3150 can extend mainly from the connecting member 3110 and / or the sealing surface 3105 in the vicinity of the patient's nose. Such a flap 3150 can assist in sealing the patient's nose adjacent to the upper part of the maxilla and the inner canthus region and / or the comfort related to the patient's nose. When using some known devices, it may be difficult to seal this area of the patient's face. Alternatively, the flap 3150 can extend from the connecting member 3110, whereby the position of the flap 3150 can be fixed relative to the connecting member 3110. FIG. 11 is a simple diagram of the connecting member 3110 as a substantially tubular structure 3120 with the flap 3150 extending therefrom internally.

[0180] FIG. 12 is a simple diagram of the substantially tubular structure 3120 shown in FIG. 11 attached to the seal forming structure 3100. According to FIG. 12, the substantially tubular structure 3120 can be separately fabricated and fastened to the seal forming structure 3100.

[0181] FIG. 13 shows a manner of obtaining compliance from the substantially tubular structure 3120 so that the seal forming structure 3100 can conform to the patient's face. Even when compliant, the present technology can prevent rupture.

[0182] The rupture can be understood as referring to a deformation of the seal-forming structure 3100 and is at least partially due to the pressure difference when pressure is applied during treatment to displace the sealing surface 3105 from sealing contact with the patient's face. For example, the patient can pull the patient interface 3000 away from the face during treatment (i.e., when pressure is applied), and if the patient interface 3000 is displaced from the patient's face by the patient, the seal-forming structure 3100 can be deformed due to the force of the treatment pressure. Next, when the patient interface 3000 is applied to the patient's face again, the sealing surface 3105 of the seal-forming structure 3100 can be displaced due to the deformation, and as a result, the seal can become ineffective and the pressurized gas can leak from the seal-forming structure 3100. When the seal-forming structure 3100 is repositioned, the internal pressurization of the plenum chamber 3200 can be obstructed, and the pressure gradient can approach the sealing flap 3125. A force can be generated due to the pressure gradient, and as a result, the sealing flap can ultimately rupture. When the sealing flap is displaced during rupture, the sealing flap can move, and a leakage path can be formed when the sealing structure is repositioned on the face, thus obstructing the seal. If the rupture of the seal-forming structure 3100 occurs in the vicinity of the patient's eye (e.g., the sealing surface 3105 near the frontal process of the maxilla is displaced), the pressurized gas can flow towards the patient and can be particularly destructive and troublesome for the patient. Therefore, it would be advantageous if rupture reduction were possible.

[0183] The rupture from the deformation in the seal-forming structure 3100 can occur outwardly (e.g., in the direction away from the patient's face). In fact, under extreme conditions where the internal pressurization is high, the seal-forming structure 3100 can be folded double backward by the rupture.

[0184] The nasal sides and the outer cartilages in the vicinity of the frontal process of the maxilla, including above the nasal bone, can vary greatly depending on the user's profile. Further, in order to seal this area, the inner edge of the sealing flap 3125 is bent inward (e.g., inward of the plenum chamber and perpendicular to the Frankfurt horizontal) and deformed to follow the profile of the nasal side. Therefore, in this area, a sealing interference that leads to rupture is particularly likely to occur. That is, when the sealing flap 3125 is displaced outward (e.g., displaced in a direction away from the patient's face) during rupture, it is often difficult to return the sealing flap to the sealing position due to the resistance from the pressurized gas force.

[0185] However, rupture can also occur in areas such as the cheek area, the upper lip area, or the lower lip area where the possibility of sealing interference is low. In the case of these areas, the profile substantially along the frontal plane is generally flatter. During rupture, the sealing flap can move greatly from the position required for sealing along this plane, and the sealing force applied from the headgear vector is often sufficient to reposition the sealing flap in the orientation required to regain sealing.

[0186] A larger surface area is obtained by the rear surface of the sealing flap that descends from the side of the nasal area to the lower corner of the sealing flap, so displacement is more likely to occur under internal pressure.

[0187] The double-wall seal-forming structure 3100 may be prone to rupture. For example, the single-wall seal-forming structure 3100 disclosed in an embodiment of the present technology is particularly prone to rupture. It can be understood that when there is no under-cushion structure to support the outer sealing wall, there is a possibility that the outer sealing wall can be more easily deformed and distorted. Further, providing an under-cushion in the double-wall cushion can assist in repositioning the outer sealing wall relative to the patient's face when repositioning the patient interface 3000, but this assistance may not be available in a single-wall cushion.

[0188] Figures 34A and 34B show examples of a related art patient interface 3000 that has ruptured internally. In Figure 34A, it can be seen that the seal - forming structure 3100 is deformable such that the sealing surface 3105 in the rupture region BR1 is displaced from the patient's nose. Further, it can be seen that the seal - forming structure 3100 can be deformed such that the sealing surface 3105 in another rupture region BR2 is displaced from the side of the patient's nose (e.g., those near the frontal process of the maxilla) (see Figure 2H). Similarly, Figure 34B shows the displacement of the sealing surface 3105 of the seal - forming structure 3200 in the rupture region BR2 at the side of the patient's nose (e.g., those near the frontal process of the maxilla).

[0189] In both of the above - described rupture examples, the patient interface 3000 is a full - face patient interface that seals around the nose and mouth. Such a patient interface has relatively weak support for the relatively elongated lateral portions in the intermediate region, and ruptures can occur within these regions, making it particularly prone to rupture. Further, the force vectors of the positioning and stabilization structure 3300 can be generally oriented parallel to the Frankfurt horizontal plane or the sagittal plane. Therefore, these force vectors may not be oriented to apply force to the seal - forming structure 3100. Since the seal - forming structure 3100 is generally directed inward in a direction perpendicular to the frontal process of the maxilla, it withstands the deformation of the seal - forming structure that causes rupture. In other words, the force of the treatment pressure that causes the deformation of the seal - forming structure 3100 can have a magnitude and direction that cannot adequately counteract the force vectors from the positioning and stabilization structure 3100. The rupture phenomenon can be particularly relevant to full - face patient interfaces, but it should also be understood that nasal patient interfaces are also prone to rupture by the same principle. Thus, by using the patch 3110 disclosed herein with nasal and full - face patient interfaces, resistance to rupture can be achieved.

[0190] Furthermore, there are related distinctions in the context of the sealing surface 3105. The sealing surface 3105 can be understood as broadly referring to the area on the seal formation structure 3100 where seal generation is intended. Since the anthropometry of each patient's head and face is different, the seal formation structure 3100 can be shaped and sized to provide a comfortable fit and an effective seal for a range of patients. Thus, it should be understood that the seal is intended to occur on various areas of the seal formation structure 3100, and the sealing surface 3105 can broadly refer to such areas. After the seal formation structure 3100 is actually added to a specific patient during use, a seal can be formed at a specific site in a wider area where seal generation is intended. The area where the seal actually occurs during use can also be understood as the sealing surface 3105. The specific meaning of the sealing surface 3105 can be understood as being exposed to the specific context in which the term is used as described above.

[0191] Returning to the rupture described above, the occurrence of rupture can be understood as referring to a situation where the sealing surface 3105 where seal generation is intended is displaced from the patient's face. When such displacement occurs, it can at least prevent an effective seal, and more simply put, the occurrence of sealed contact can be completely eliminated.

[0192] FIG. 14 shows another aspect of the present technology that can prevent the rupture of the seal formation structure 3100. Here, two ribs 3155 are shown, but any number of ribs can be provided. For example, a single rib or three or more ribs can be provided. Similar to the connecting member 3110, each rib 3155 tends to prevent the rupture of the seal formation structure 3100 (e.g., the sealing surface 3105). These ribs may have the same thickness or different thicknesses. For example, one or both of the ribs 3155 can be about 1 mm thick, and one or both of the ribs 3155 can be about 0.5 mm thick. Alternatively, these ribs may have a variable thickness. The sealing surface 3105 can be convex at the location where the rib 3155 is attached, and can be concave at the location where the opposite rib 3155 is attached. Therefore, the convex and concave surfaces define the thickness of the material in that region. The rib 3155 can be provided adjacent to the patient's nose.

[0193] FIG. 15 shows a cross-section of the seal formation structure 3100 taken perpendicular to the surface of the rib 3155. Since the rib 3155 can be made relatively compliant when compressed or can be easily crushed under the sealing load, the seal formation structure 3100 and / or the sealing surface 3105 can conform to the patient's face. This is shown in FIG. 16. However, as shown in FIG. 17, the rib 3155 can provide relatively high resistance to the tension that can occur when the inside of the seal formation structure 3100 (e.g., the surface 3105a facing the sealing surface 3105) is pressurized. In this way, the rib 3155 can tend to resist the rupture of the seal formation structure 3100 (e.g., the rib 3155 can be a tension member). For example, the rib 3155 tends to hold the seal formation structure 3100 in a "as-molded" state or the shape under the ruptured state.

[0194] With the extension flap 3160 shown in FIGS. 18 and 19, it may be possible to increase the distance D1vsD2 to accommodate facial variations when the distance between the nasal side and the sealing flap changes. The sealing surface 3105 of the extension flap 3160 can also provide an effective seal against the cheek. The arrows indicate areas where contact with the patient may occur. This main structure is mainly sealed using a film on a conventional silicone mask and is prone to rupture during readjustment of the mask position. The splice 3110 or rib 3155 can prevent rupture from occurring while allowing for distance changes due to facial differences that need to be effectively sealed.

[0195] FIG. 20 shows a view similar to FIG. 6, except that a pattern is included on the seal-forming structure 3100. These patterns indicate regions 3175 of similar thickness of the seal-forming structure 3100.

[0196] Region 3175A can be a relatively thin region (e.g., about 0.3 mm). This region can be made thin and compliant for comfort at the bridge of the nose.

[0197] Region 3175B can be an extremely thin region (e.g., about 0.2 mm). By reducing the thickness relative to region 3175A, the tension can be significantly reduced, and as a result, facial imprints at the bridge of the nose can be minimized. Since the bridge of the nose is a bony part in most patients, imprints and / or discomfort are likely to occur.

[0198] Region 3175C can be a semi-thin region (e.g., about 1 mm). This region can be made semi-thin to prevent pinching at the nasal side.

[0199] Region 3175D can be a semi-thick region (e.g., about 1.5 mm). This region can seal the cheek along the nose. This area on the face is typically fattier than the sides of the nose or the bridge of the nose, so a relatively large sealing force can be applied without discomfort. The semi-thick region can also provide a higher structural rigidity than the thinner regions.

[0200] Region 3175E can be a thick region (e.g., about 2.0 mm). This thicker peripheral region can provide a high-rigidity outer wall for supporting the inner part of the cushion. Region 3175E can function like an under-cushion in a conventional double-layer cushion design. For example, Region 3175E can support the site(s) of the seal-forming structure 3100 that contacts the patient's face. For example, Region 3175E can provide support to Region 3175D and / or 3175F (described later). The overall cross-sectional shape of the cushion can be curved to provide an air (pressure)-assisted spring for seal and compliance. In this configuration, the disclosed configuration including such a thick region can also be compressed to provide a certain level of compliance for assisting seal formation, which can be advantageous compared to the prior thick under-cushions of masks. As a result, it may be possible to increase the overall distance range within which the cushion can be compressed compared to a conventional double-layer design.

[0201] Region 3175F can be a thin film region (e.g., about 0.3 - 0.5 mm). The site that seals the lower lip underside can be thin (e.g., about 0.3 mm) to allow movement of the lower jaw. Such a thin film region can also reduce the load on the patient's gums for comfort. This site of Region 3175F adjacent to Region 3175D is where the connecting member 3110 is disposed. This site of Region 3175F is thin (e.g., about 0.5 mm), allowing compression of the connecting member 3110. The site of Region 3175F configured to contact the side of the patient's oral cavity can be about 0.5 mm and function like the sealing membrane layer of a double-layer cushion, thereby maintaining the seal with the fine changes in the facial profile and movement during sleep.

[0202] Although distinct lines are shown between Regions 3175, the boundaries between these regions are approximate because these regions can transition smoothly in terms of the relative thickness between regions. This can be advantageous because the ability to visually distinguish between thick and thin regions is limited, which can improve the aesthetics. However, distinct transitions can also be provided.

[0203] In International Patent Application Publication WO2006 / 074513, a cushion is disclosed. The entire document is incorporated herein by reference. In such a cushion, a thicker under-cushion and a thinner film layer are disclosed. The thinner film reduces the seal on the face under pressure (i.e., expands), and the under-cushion provides support for maintaining the seal. The curved cross-section provides a pressure assist spring for supporting the seal under headgear tension.

[0204] In contrast, the seal-forming structure 3100 having one or more of the above-described regions 3175 may have only a single layer. This single layer may combine the functions of the membrane and under-cushion of WO2006 / 074513. The maximum thickness of the cross-section of the region 3175 (e.g., region 3175E) may be thinner than the maximum thickness of the under-cushion of WO2006 / 074513. However, by combining the under-cushion and the membrane into a single layer, sufficient structural rigidity is obtained to maintain the cushion shape and the support and sealing functions. Further, due to the reduction in the maximum thickness, the compression of the single layer of the seal-forming structure 3100 can be carried out over a greater distance than in the case of a conventional double-layer design, thus increasing the compliance before bottoming out.

[0205] In a mask provided in a system disclosed in International Patent Application Publication WO2014 / 117227, a foam cushion is supported by a flexible clip attached to a second high-rigidity clip. The entire contents of each of these are incorporated herein by reference. In a similar system disclosed in FIG. 21, two ribs 3155 are employed. These ribs are configured to be provided on opposite sides of the patient's nose. Only one rib is illustrated in FIG. 21. These ribs function as a connecting member to prevent the rupture of the flexible clip and the attached foam seal. Although the rib 3155 is illustrated, a connecting member 3110 may be used instead of the rib 3155.

[0206] Thus, in another embodiment of the present technology, the seal forming structure 3100 includes a cushion 3810 that can be composed of a foam. This cushion defines a single area that covers the area around the patient's nose in the case of a nasal mask and covers the area around the nose and mouth in the case of a full face mask. The foam cushion can be composed of, for example, any suitable material (e.g., one or more of polyethylene, polyurethane, ethylene vinyl acetate (EVA)). In some cases, the foam cushion can be a semi-open closed cell foam (e.g., made of polyurethane). The cushion of the semi-open cell foam may have limited permeability (e.g., within the range described in more detail in International Patent Application Publication WO2014 / 117227). The permeability disclosed in the same document is incorporated herein by reference for reference purposes.

[0207] The cushion 3810 can have a substantially triangular or oval shape and has a sealing surface that follows the contour of the user's face. The foam cushion is designed to be attached to a first support (e.g., flexible) clip 3812. The first support clip 3812 itself is attached to a second high-rigidity clip 3814 (as shown in FIG. 22) or directly attached to the mask shell 3816. In one embodiment, the first support clip 3812 can be a flexible clip, which is more rigid than the foam cushion and more flexible than the second clip 3814. This is a combination of the foam and the flexible clip, which defines the physical properties of the overall sealing interface. The flexible clip enables the interface to accommodate large changes and fit well to the contour of the patient's face. The compliance of the foam cushion allows for fine adjustment and forms a comfortable interface layer that interacts with the patient's skin.

[0208] The first support clip 3812 may be prone to rupture due to flexibility and compliance. According to another aspect of the present technology shown in FIG. 21, rupture of the first support clip 3812 and the attached cushion 3810 can be prevented. Here, the illustrated configuration includes two ribs 3155 (only one of which is shown due to symmetry and orientation of the drawing), although any number of ribs may be provided. For example, a single rib or three or more ribs may be provided. Similar to the connecting member 3110, each rib 3155 tends to prevent rupture of the first support clip 3812 and the attached cushion 3810 by functioning as a tension member. These ribs may be of the same thickness or of different thicknesses. For example, one or both of the ribs 3155 may be about 1 mm thick, and one or both of the ribs 3155 may be about 0.5 mm thick. Alternatively, these ribs may have a variable thickness. The rib 3155 may be provided adjacent to the patient's nose.

[0209] FIG. 21 shows a side view of the cushion assembly 3800. The cushion assembly 3800 includes a seal-forming structure 3100. The seal-forming structure 3100 includes a mask shell 3816, a permanently attached flexible first support clip 3812, and a foam cushion 3810. As shown, the flexible first support clip can be fixed to the mask shell 3816 via a pair of ribs 3155 that function as connecting members to prevent rupture. These ribs 3155 can be relatively compliant when compressed or can be easily crushed under a sealing load, so that the seal-forming structure 3100 can conform to the patient's face. Adjustment of the tension provided by the ribs 3155 can be done by changing any one or more of its material composition, the geometry or position of the ribs 3155.

[0210] FIG. 23 shows the foam cushion 3810 and the flexible first support clip 3812, through which the patient contact surface can be viewed. FIG. 23A is a cross-section along a symmetric vertical plane taken through FIG. 23, showing the foam cushion, the flexible first support clip 3812, and the rib 3155.

[0211] In another embodiment of the present technology, the seal forming structure 3100 may include a pair of connecting members 3110 for preventing rupture of the first support clip 3812. Each connecting member 3110 is formed by an inner bending of the outer flexible support clip 3812, thereby forming a connection point 3165. In this way, the connecting member 3110 may form a substantially tubular structure 3120. The connecting member forms a connecting member that withstands rupture from internal pressurization of the plenum chamber. The tension provided by the rib 3155 can be adjusted by any one or more of changes in its material composition, the geometry or position of the connection point 3165 of the connecting member 3110.

[0212] Figures 24A - 27F show a cushion assembly 6000 that is similar to the seal forming structure 3100 except as described hereinabove. Since like reference numerals are the same as those described for the seal forming structure 3100, a further detailed description is omitted. The cushion assembly 6000 shown in Figures 24A - 27F may have features that are particularly suitable for use with a nasal mask.

[0213] FIG. 24A is a perspective view of one form of the cushion assembly 6000 separated from the remainder of the patient interface 3000. FIG. 24B is a perspective view of the cushion assembly 6000 including the shell 6005. Both the cushion assembly 6000 and the shell 6005 can form the plenum chamber 3200. The cushion assembly 6000 can be attached to the shell 6005 by any means (e.g., chemical bonding, mechanical connection, or adhesive). Additionally, the cushion 6000 may be removable from the shell 6005 or may be permanently attached to the shell 6005. Also, the cushion assembly 6000 can have a higher flexibility than the shell 6005. For example, the cushion assembly 6000 can be made of a silicone material and the shell 6005 can be made of a polycarbonate material. It is contemplated that part or all of the cushion assembly 6000 can be matte-finished and the shell 6005 can be transparent. Alternatively, the cushion assembly 6000 and the shell 6005 can be made entirely transparent.

[0214] The cushion assembly 6000 can include an elastomeric seal-forming structure 6010 and an elastomeric support structure 6015 that supports the seal-forming structure 6010. The seal-forming structure 6010 can have a higher flexibility than the support structure 6015, and the support structure 6015 can have a higher flexibility than the shell 6005.

[0215] The seal-forming structure 6010 can include a sealing flap 3125 and can be configured to form a seal around the patient's airway. The seal can be formed around the patient's nose or around the patient's nose and mouth. Additionally, the seal-forming structure 6010 can form a central opening (or rear central opening) 6020 on the rear side of the cushion assembly 6000, thereby allowing access to the inside of the plenum chamber 3200 through the cushion 6000.

[0216] In addition, as can be seen from FIGS. 24A and 24B, the connecting member 3110 is anchor-fixed to the support structure 6015 at the attachment point 3145. In addition, the interior of the plenum chamber 3200 and the tubular (or tube-shaped) structure 3120 formed by the connecting member 3110 and the cushion assembly 6000 can be bounded by the same inner surface of the seal-forming structure 6010. In other words, the tubular (or tube-shaped) structure 3120 and the plenum chamber 3200 can be bounded by a common surface of the cushion assembly 6000.

[0217] FIGS. 25B to 25G also show various cross-sections of FIG. 25A. Here, the intersection of the cross-sections indicates that the seal-forming structure 6010 includes various saddles and hemispheres. For the sake of brevity, in this specification, the intersections of the various cross-sections are indicated by two-letter combinations. For example, the intersection of the cross-section taken along line 25B-25B and the cross-section taken along line 25C-25C is called intersection BC.

[0218] Intersection BC is taken in a first saddle region configured to contact the patient's nasal sill below the patient's septum. Along line 25B-25B, the curvature is relatively small, and along line 25C-25C, the curvature is relatively large. The curvature along line 25B-25B is large enough such that the first saddle region approaches a cylindrical region. If desired, the first saddle region may be made a cylindrical region. Intersection BD is taken in a second saddle region configured to contact the patient's upper lip. When along line 25B-25B, the curvature is relatively smaller than when along line 25D-25D. Intersection CF is taken in a first dome region configured to contact the patient's nose adjacent to the nasal sill. Along lines 25F-25F and 25C-25C, the curvatures are relatively similar. Intersection FG is taken in a third saddle region formed by a connecting member 3110 configured to contact side-by-side on the patient's nose. The curvature along line 25F-25F is relatively small and approaches a zero curvature. The curvature along line 25G-25G is relatively large compared to line 25F-25F. Thus, the third saddle region is close to a cylindrical region and may be made a cylindrical region if suitable. Intersection EF is taken in a second dome region configured to contact the patient side-by-side on the patient's nasal ala. The curvatures along lines 22E-22D and 22F-22F are relatively similar.

[0219] Figures 27A and 27B show a view of the seal forming structure 6010 except that a pattern is provided on the seal forming structure 6010. These patterns specify similar characteristics and / or thicknesses of the seal forming structure 6010. Figure 27B shows the positional relationship between the connecting member 3110 and different regions.

[0220] When the patient interface 3000 is attached on the patient's face, a region 6010A (which may be referred to as the nasal bridge region) may engage with the patient's nasal bridge. Additionally, the region 6010A may extend from the central opening 6020 to the support structure 6015.

[0221] Since the elastomer wall thickness of the seal-forming structure 6010 is thinnest in the region 6010A, the seal-forming structure 6010 can be the most compliant on the patient's nasal bridge. For example, the elastomer wall thickness of the seal-forming structure 6010 in the region 6010A can be about 0.25 mm. As a result, reduction of red marks near the patient's nasal bridge can be promoted. However, since the seal-forming structure 6010 is thin within the region 6010A, the portion of the seal-forming structure 6010 within the region 6010A may not be able to maintain its shape when subjected to the forces that occur when the patient interface 3000 is pressed against the patient's face and may move relative to the patient's face (which can occur during a treatment session). Therefore, due to the thinness of the seal-forming structure 6010 in the region 6010A, wrinkles and / or folds are likely to occur at the portion of the seal-forming structure 6010 within the region 6010A, which can result in leakage and / or discomfort.

[0222] A pair of regions 6010B (which may be referred to as spring regions or nasal bridge support regions) can be located on the sides of the region 6010A. The regions 6010B can extend from the support structure 6015 such that they do not reach the central opening 6020, whereby the first end 6025 of each region 6010B can be anchored in place and the second end 6030 of each region 6010B can move freely in response to the compressive forces acting on the seal-forming structure 6010.

[0223] The elastomer wall thickness of each region 6010B can vary between the first end 6025 and the second end 6030. The elastomer wall thickness of region 6010B can be thickest at the first end 6025 and thinnest at the second end 6030. For example, the elastomer wall thickness of the first end 6025 can be about 1.35 mm, and the elastomer wall thickness of the second end 6030 can be about 0.9 mm. The elastomer wall thickness of the seal forming structure 6010 in each region 6010B may be tapered from the first end 6025 to the second end 6030, or it is contemplated that it may change abruptly from the first end 6025 towards the second end 6030. In any case, the elastomer wall thickness of the seal forming structure 6010 throughout each region 6010B can be thicker than the elastomer wall thickness of the seal forming structure 6010 in region 6010A.

[0224] Region 6010B can be separate from ribs structured to provide overall support for the cushion. For example, the curvature of the seal forming structure 6010 in region 6010B can be different from the curvature (or lack of curvature) of the ribs. For each point in region 6010B, the inner surface of the seal forming structure 6010 (the surface facing and bounding the plenum chamber 3200) and the outer surface of the seal forming structure 6010 (the surface facing the inner surface and facing away from the plenum chamber 3200) can have opposite types of curvatures. For example, if the inner surface of the seal forming structure 6010 at a particular point within region 6010B has a positive curvature, the outer surface of the seal forming structure 6010 at the same point within region 6010B has a negative curvature. The same can be said if the inner surface has a negative curvature. In other words, the curvature of the inner surface can follow the curvature of the outer surface.

[0225] The seal forming structure 6010 can be structured such that the radius of curvature of the curvature of the seal forming structure 6010 reduces from the "neutral radius of curvature" in response to the compressive force acting on the seal forming structure 6010. The seal forming structure 6010 in each region 6010B can "spring back" to the neutral radius of curvature when there is no compressive force.

[0226] Due to the "spring action" of region 6010B, support for region 6000A can be obtained, whereby wrinkles and / or folds in the portion of the seal-forming structure 3110 within region 6010A can be prevented or reduced. Specifically, by thinning the elastomer wall thickness within region 6010A, when the seal-forming structure 6010 is pressed against the patient's face and / or when the seal-forming structure 6010 is moved or rubbed on the patient's face due to the patient's movement during sleep, the seal-forming structure 6010 within region 6010A may not be able to provide resistance against wrinkles and / or folds. The "spring force" provided by region 6010B can act against the "surface of the patient's face" and / or against the side of the patient's nose. Since region 6010B is arranged alongside region 6010A, the "spring force" generated by region 6010B can provide sufficient support to region 6010A such that region 6010A can withstand wrinkles and / or folds at least partially. Region 6010B can also enable region 6010A to maintain a seal with the patient's face if there are any wrinkles and / or folds in region 6010A. As a result, while improving comfort, the cushion assembly 6000 can maintain a seal with the patient's face.

[0227] A pair of regions 6010C (which may be referred to as compliant regions) are arranged alongside region 6010B, such that each region 6010B is sandwiched between region 6010A and region 6010C. Similar to region 6010B, the elastomeric wall thickness of the seal forming structure 6010 within each region 6010C may vary such that region 6010C tapers from the support structure 6015 towards the central opening 6020. It should be understood that the elastomeric wall thickness of the seal forming structure 6010 within region 6010C may be thicker towards the support structure 6015 and thinner towards the central opening 6020. For example, the elastomeric wall thickness within region 6010C may vary from approximately 0.25 mm at a location adjacent to the central opening 6020 to approximately 1.30 mm at a location adjacent to the support structure 6015. At the location where region 6010B meets region 6010C, the elastomeric wall thickness within region 6010B may always be thicker than the elastomeric wall thickness within the corresponding region 6010C. Additionally, the change from the thickest elastomeric wall thickness to the thinnest elastomeric wall thickness may be abrupt or gradual.

[0228] A pair of regions 6010D (which may be referred to as membrane regions) may be directly adjacent to the central opening 6020. Additionally, since region 6010D may have the same thickness as region 6010A (i.e., approximately 0.25 mm), it may function as a biased (e.g., pressure activated) seal against the patient's face. The pair of regions 6010D may form approximately one third of the seal forming structure 6010 and may include the connecting member 3110.

[0229] (An area that may be referred to as the lip area) Area 6010E may be configured to engage the patient's face above the patient's upper lip. As shown, the cushion assembly 6000 within this area may be curved to avoid digging into the patient's upper lip. Additionally, area 6010E may have the same thickness (i.e., approximately 0.25 mm) as areas 6010A and 6010D. Thereby, the seal-forming structure 6010 can be made more compliant with respect to the area adjacent to the patient's upper lip. Additionally, similar to area 6010A, area 6010E may extend from the central opening 6020 to the support structure 6015. Therefore, areas 6010A, 6010D, and 6010E can together form a continuous membrane layer from the lower side to the upper side of the seal-forming structure 6010.

[0230] (An area that may be referred to as the "under-cushion" area) A pair of areas 6010F may be the main areas of the seal-forming structure 6010. Area 6010F may have the same function as the "single-wall" cushion assembly 6000, as the under-cushion layer has in a "double-wall" cushion (i.e., providing support for the membrane). In the case of the cushion assembly 6000, area 6010F may support areas 6010D and 6010E where the elastomer wall thickness is the thinnest.

[0231] The elastomer wall thickness of the seal-forming structure 6010 in area 6010F may vary. Specifically, the elastomer wall thickness may increase towards the support structure 6015. For example, the elastomer wall thickness of area 6010F may be approximately 1.0 mm adjacent to areas 6010D and 6010E and may be approximately 2.0 mm adjacent to the support site 3125. The change in the elastomer wall thickness may be abrupt or gradual.

[0232] (An area that may be referred to as the side support area) Area 6010G may have the maximum elastomer wall thickness in any area of the seal forming structure 6010. The elastomer wall thickness of the seal forming structure 6010 may be about 1.35 mm to 3.45 mm. For example, the elastomer wall thickness may be about 1.35 mm to about 2.00 mm. One or more sub-areas within area 6010G may have an elastomer wall thickness of about 0.90 mm to about 1.80 mm. It is contemplated that area 6010G may have a constant elastomer wall thickness or, alternatively, a variable elastomer wall thickness that increases as it approaches the support structure 6015. When the elastomer wall thickness changes, the change in thickness may be abrupt or gradual. Area 6010G may provide support or a base for the sealing flap 3125 and may provide or maintain the overall shape of the seal forming structure 6010.

[0233] As shown in FIGS. 27A-27D, the cushion assembly 6000 may be divided into a left side 6035 and a right side 6040 by a sagittal plane 6045. A line 6050 that may be included in the sagittal plane 6045 is tangent to the seal forming structure 6010 only at two points (i.e., the first contact point (upper contact point) 6055 and the second contact point (lower contact point) 6060).

[0234] Area 6010A may span the sagittal plane 6045 and may include the first contact point 6055. Also, comparing FIGS. 27A and 27B with FIGS. 25B-26G, it can be seen that a part of area 6010A including the first contact point 6055 may be saddle-shaped.

[0235] Area 6010B may be symmetric with respect to the sagittal plane 6045. In addition, each area 6010B may be most distant from the sagittal plane 6045 at the first end 6025 and may be closest to the sagittal plane 6045 at the second end 6030. In addition, at least a part of each area 6010B may be disposed within an area of the seal forming structure 6010 that changes from a saddle shape to a hemispherical shape. In addition, area 6010B may be disposed on the cylindrical portion of the seal forming structure 6010.

[0236] As can be seen by comparing FIGS. 25B to 25G with FIGS. 27A and 27B, the region 6010C can be hemispherical. A part of the regions 6010F and 6010G can also be hemispherical. The radius of the hemispherical curved portion in the region 6010C can be smaller than the radius of the hemispherical curved portion in the region 6010F. Also, a part of the regions 6010F and 6010G can be cylindrical.

[0237] The region 6010D can straddle the sagittal plane 6045 and can include the second contact point 6055. Also, as can be seen by comparing FIGS. 27A and 27B with FIGS. 25B to 26G, a part of the region 6010D including the second contact point 6055 can be made saddle-shaped. It is contemplated that the radius of the curved portion in the region 6010D can be larger than the radius of the curved portion in the region 6010A.

[0238] As shown in FIG. 27E, the seal formation structure 6010 can have a continuous surface around the central opening 6020. Therefore, the seal formation structure 6010 can have a plurality of closed paths 6065 coaxial with the central opening 6020. For the purposes of the present disclosure, a path coaxial with the central opening 6020 can substantially follow the shape of the central opening 6020 and can be a specific distance from the central opening 6020 throughout the path when viewed from the front (i.e., when viewed from the perspective shown in FIG. 27E). FIG. 27E also shows one of the plurality of open paths 6070 extending from the central opening 6020 to the support site 6015.

[0239] Figures 27F and 27L show an exemplary cushion assembly 6000 including a shell 6005. As will be understood, at certain points within the cushion assembly 6000, the seal-forming structure 6010 may project beyond the support structure 6015. In these regions, the seal-forming structure 6010 may have a "sickle" shape. This "sickle" shape is clearly illustrated by the cross-sections shown in FIGS. 27M-27R. It should be understood that the cross-section of the cushion along a line (e.g., a line extending through the central region of the cushion as shown in FIG. 27L) may have a closed-loop shape in some regions and an open shape in other regions. At the "closed-loop" sites, both edges of the cushion may be fixed in place. At the "open" sites, one end of the cushion may be fixed in place and the other end may be a free end, not fixed to anything and allowed to move freely.

[0240] The support structure 6015 may include a pair of flange portions 6075 on opposite sides of the sagittal plane 6045 facing downward of the cushion assembly 6000. The flange portions 6075 may extend radially outward from the support structure 6015. Additionally, the seal-forming structure 6010 may be attached to the outer edge of the flange portion 6075 such that when a compressive force acts on the seal-forming structure 6010, the flange portion 6075 pivots in a hinge-like manner around the base 6080 of each flange portion 6075. In this way, each flange portion 6075 may function as a shock absorber when the seal-forming structure 6010 receives a compressive force (e.g., due to the cushion assembly 6000 being compressed by a patient's head).

[0241] The flexibility of the support structure 6015 may be related to the distance between the front side and the rear side of the support structure 6015. For example, when the distance between the front side and the rear side is shorter, the flexibility of the support structure 6015 may be lower (FIGS. 27M and 27R). Conversely, when the distance between the front side and the rear side is longer, the flexibility of the support structure 6015 may be higher (FIGS. 27O and 27Q). In other words, since the distance changes between the front side and the rear side of the support structure 6015, the support structure 6015 may support the seal forming structure 6010 more greatly at the upper and / or lower portions of the cushion assembly 6000 than at other portions of the cushion assembly 6000.

[0242] FIGS. 28A to 28M show an exemplary full-face seal forming structure 3100 including a connecting member 3110. As can be seen from FIG. 28K, for example, the connecting member 3110 may extend between a first inner surface region 3180 and a second inner surface region 3185. The first inner surface region 3180 may be understood to be on the opposite side of the sealing surface 3105 of the seal forming structure. The second inner surface region 3185 may be understood to be elsewhere. In the embodiment shown in FIG. 28K, the second inner surface region 3185 is disposed on the inside of the seal forming structure 3100. In other embodiments, the second inner surface region 3185 may be disposed on the inside of the plenum chamber 3200 such that the connecting member 3110 extends between the seal forming structure 3100 and the plenum chamber 3200. The position of the second inner surface region 3185 may be selected based on the desired directional component of the tension vector of the connecting member 3100 that withstands the bursting force.

[0243] Figures 28L and 28M are detailed cross-sectional views, and in particular, show the connection point 3165 where the connecting member 3110 extends from the second inner surface region 3165. The connection point 3165 in this embodiment can be curved to reduce stress concentration in this region, thereby reducing the tendency for the connecting member 3110 to break. Further, the connecting member 3110 can extend from the second inner surface region 3185 at a certain distance from the joining region 3190 where the seal-forming structure 3100 is joined to the plenum chamber 3200 during manufacture. Thereby, damage to the connecting member 3110 when joining the seal-forming structure 3100 to the plenum chamber 3200 can be prevented. Figures 29C - 29E also show the manner in which the connecting member 3110 extends from the second inner surface region 3185 at the distance from the joining region 3190 and the plenum chamber 3200.

[0244] The cross-sectional views of FIGS. 28J - 28L also show the manner in which the connecting member 3110 can extend from the first inner surface region 3180. As can be seen from these embodiments, the connecting member 3110 extends from the first inner surface region 3110 which is adjacent to and not the seal flap 3125. However, in another embodiment, the connecting member 3110 can extend from the first inner surface region 3180 closer to or at the edge of the seal flap 3125.

[0245] Figures 30A and 30B show an embodiment of a full-face patient interface 3000 that includes the seal-forming structure 3100 incorporating the features of the present technology and does not include the described positioning and stabilization structure 3300.

[0246] Figures 31A - 31M show another embodiment of the present technology which is the nose seal-forming structure 3100. As can be seen from FIG. 31K, for example, the connecting member 3110 extends in proximity to the seal flap 3125. Therefore, there may be no defined edge in this region. Further, it should be understood that at least a portion of the connecting member 3110 in such an arrangement configuration can form a part of the sealing surface 3105 according to the anthropometry of the patient's face during use.

[0247] Figs. 32C - 32E show that in an embodiment of the nasal patient interface 3000, the bridging member 3110 can extend from the second inner surface region 3185 at a further distance from the junction region 3190 as compared to the full face patient interface 3000.

[0248] Figs. 33A - 33C show that the frame (or shroud) 6085 can function as a hub for the entire patient interface system. Specifically, the frame 6085 can be removably connected to the shell 6005 and is removably connected to the stabilization structure 3300. Additionally, the frame 6085 can be removably connected to the air circuit 4170. Additionally, the shell 6005 can include a flexible lip seal at the central opening. This flexible lip seal can seal the air path from the air circuit 4170 to the plenum chamber 3200. By focusing on the modular configuration using the frame 6085, the cushion assembly 6000 and the shell 6005 can be interchangeable with other cushion assemblies 6000 and shells 6005. Additionally, the modular configuration allows the patient interface system to be removed without the need to adjust the support structure 3300.

[0249] Fig. 35 shows another exemplary sealing structure 7000. Since the region 7005A, referred to herein as the nasal region, can be about 0.5 mm thick, wrinkles and / or folds of the sealing structure 7000 within this region can be prevented.

[0250] The region 7005B, referred to herein as the base region, can be about 2.9 mm - 3.45 mm thick. For example, the thickness can be 2.9 mm at 7005B2, 3.0 mm at 7005B1 and 7005B3, and 3.45 mm at 7005B4. The region 7005B can provide support or a base for the sealing flap 3125 and can provide and maintain the overall shape of the sealing structure 7000.

[0251] In this specification, the region 7005C, referred to as the under-cushion zone, can have a thickness of 0.95 mm to 2.1 mm. As shown in the figure, this region can be the main region of the cushion. For example, the region 7005C can be approximately 50% of the cushion. The thickness of the upper part of the region 7005C1 can be 0.95 mm to 1.6 mm, and the thickness of the lower part of the region 7005C2 can be 1.25 mm to 2.1 mm. This thickness can vary continuously between these values to provide a smooth appearance.

[0252] The region 7005D, referred to as the membrane region in this specification, can form approximately 1 / 3 of the seal formation structure 7000 and can include the connecting member 3110. The thickness can be approximately 0.35 mm. Since this region can be relatively thin, it can function as a seal biased (e.g., pressure-activated) against the patient's face. The side part 7005D1 can be substantially parallel to the patient's face, so the possibility of folds and the resulting leakage can be reduced. Such wrinkles are more likely to occur in dynamic situations (e.g., when the seal is moving).

[0253] The region 7005F, referred to as the spring zone in this specification, can have a thickness of 1.1 mm to 1.8 mm. This zone can function as a spring, allowing compression on the upper lip and reducing the pressure on the upper lip. This region can gradually increase in stiffness from the center of the upper lip (where the stiffness of 7005F is highest from the center of the region) to the corner of the nose (e.g., the apex of the ala).

[0254] The region 7005G, which can be referred to as the nasal depression region in this specification, can be made relatively deeper so as to better accommodate the patient when the patient's nasal bridge is relatively high and / or to make the seal more comfortable. Since this region can have a thickness similar to that of the region 6005D (e.g., approximately 0.35 mm), it can be a sub-region of the region 7005D.

[0255] The terms "soft" and "flexible" and their derivatives, as used herein to describe the first support clip 3812, are intended to have the meaning of the term "elastic", as specifically defined in the section "terms used in relation to the patient interface". That is, the flexible support clip is substantially elastically deformable and can substantially rapidly release all of the energy during unloading.

[0256] The seal-forming structure 3100 can have advantages in one or more forms of the present technology. For example, since the structure of the human face can vary from individual to individual, it can be a problem when designing seals for use with a number of different faces. Such differences include different shapes of the facial structure (e.g., different shaped noses and / or different curved cheeks) and / or different tissue contents (e.g., differences in the amount of adipose tissue). Due to these differences, in the case of conventional seal-forming structures, it may function well for some people while not functioning well for others. Also, the perception of comfort can vary from individual to individual independently of the facial structure. By using the seal-forming structure 3100 described herein, a higher proportion of users can effectively use the seal-forming structure 3100 compared to conventional seal-forming structures (e.g., a higher proportion of users can have the seal-forming structure 3100 to form an effective seal and / or a higher proportion of users can perceive the seal-forming structure 3100 as comfortable).

[0257] 5.3.2 Prenum Chamber

[0258] The prenum chamber 3200 has an edge shaped complementary to the surface contour of the 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 close 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 can extend around the entire edge of the prenum chamber 3200 during use.

[0259] In certain forms of the technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). The use of a transparent material can reduce the constrictiveness of the patient interface 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.

[0260] In certain forms of the technology, the plenum chamber 3200 is composed of a translucent material. By using a translucent material, the constrictiveness of the patient interface can be reduced and compliance with treatment can be assisted.

[0261] 5.3.3 Positioning and Stabilization Structure

[0262] The seal-forming structure 3100 of the patient interface 3000 of the technology can be held in a sealed position by a positioning and stabilization structure 3300 during use.

[0263] In one form, the positioning and stabilization structure 3300 provides a holding force sufficient to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0264] In one form, the positioning and stabilization structure 3300 provides a holding force sufficient to overcome the gravitational pull on the patient interface 3000.

[0265] In one form, the positioning and stabilization structure 3300 provides a holding force as a safety margin to eliminate the possibility of a destructive action on the patient interface 3000 (e.g., due to tubing drag or accidental interference with the patient interface).

[0266] In one aspect of the present technology, a positioning and stabilization structure 3300 is provided that is configured to be worn by a patient during sleep. In one embodiment, the positioning and stabilization structure 3300 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 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.

[0267] In one aspect of the present technology, a positioning and stabilization structure 3300 is provided that is configured so as not to be overly large or bulky such that it would interfere with a patient lying in a supine sleep position with the patient's head resting on a pillow in the posterior region of the patient's head.

[0268] In one aspect of the present technology, a positioning and stabilization structure 3300 is provided that is configured so as not to be overly large or bulky such that it would interfere with a patient lying in a lateral sleep position with the patient's head resting on a pillow in the lateral region of the patient's head.

[0269] In one aspect 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 aspect, the foam material is porous such that moisture (e.g., sweat) can pass through the strap. In one aspect, the fabric outer layer includes a tie material that engages with a hook material portion.

[0270] In a particular aspect 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 when in use and direct a force to keep a cushion in close contact with a portion of the patient's face. In one embodiment, the strap can be configured as a tie.

[0271] In certain forms of the technology, the positioning and stabilization structure 3300 includes straps that are bendable and, for example, non-rigid. An advantage of this aspect is that the straps are more comfortable when the patient lies on their side during sleep.

[0272] In certain forms of the technology, the positioning and stabilization structure 3300 includes straps configured to be breathable such that water vapor can pass through them.

[0273] In certain forms of the 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 can include a form of the positioning and stabilization structure 3300 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.

[0274] 5.3.4 Ventilation

[0275] In one form, the patient interface 3000 includes a ventilation portion 3400 configured and arranged to allow the expulsion of exhaled gas (e.g., carbon dioxide).

[0276] One form of the ventilation portion 3400 according to the technology includes a plurality of holes (e.g., from about 20 to about 80 holes or from about 40 to about 60 holes or from about 45 to about 55 holes).

[0277] The ventilation portion 3400 can be disposed within the plenum chamber 3200. Alternatively, the ventilation portion 3400 is disposed within a disconnect structure (e.g., a swivel joint).

[0278] 5.3.5 Disconnect Structure(s)

[0279] One form of the patient interface 3000 includes at least one disconnect structure (e.g., a swivel joint or a ball and socket).

[0280] 5.3.6 Connection Port

[0281] The connection port 3600 enables connection to the air circuit 4170.

[0282] 5.3.7 Frontal Support Portion

[0283] In one form, the patient interface 3000 includes a frontal support portion 3700.

[0284] 5.3.8 Anti - asphyxiation Valve

[0285] In one form, the patient interface 3000 includes an anti - asphyxiation valve.

[0286] 5.3.9 Port

[0287] 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.

[0288] 5.4 RPT Device

[0289] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300. The RPT device 4000 may be configured to generate an air flow that is delivered to a patient's airway for treatment of one or more of the respiratory conditions described anywhere in this document, for example.

[0290] The RPT device may have an external housing 4010 formed as two parts, an upper part 4012 and a lower part 4014. Further, the external housing 4010 may include one or more panel(s) 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0291] The pneumatic path of the pneumatic RPT device 4000 may include one or more pneumatic circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) as well as one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0292] One or more of the pneumatic circuit items may be arranged within a removable integrated structure herein referred to as a pneumatic block 4020. The pneumatic block 4020 may be arranged within the external housing 4010. In one form, the pneumatic block 4020 is supported by the chassis 4016 or formed as part of the chassis 4016.

[0293] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, transducers 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0294] 5.4.1 RPT device mechanical and pneumatic components

[0295] The RPT device may include one or more of the following components in an integrated unit. In an alternative form, one or more of the following components may be arranged as separate units.

[0296] 5.4.1.1 Air filter(s)

[0297] The RPT device according to one form of the present technology may include an air filter 4110 or a plurality of air filters 4110.

[0298] In one form, the inlet air filter 4112 is arranged at the beginning of the upstream of the air pressure path of the pressure generator 4140.

[0299] In one form, the outlet air filter 4114 (e.g., antibacterial factor) is arranged between the outlet of the air pressure block 4020 and the patient interface 3000.

[0300] 5.4.1.2 Muffler(s)

[0301] The RPT device according to one form of the present technology may include a muffler 4120 or a plurality of mufflers 4120.

[0302] In one form of the present technology, the inlet muffler 4122 is arranged above the pressure generator 4140 within the air pressure path.

[0303] In one form of the present technology, the outlet muffler 4124 is arranged between the pressure generator 4140 and the patient interface 3000 within the air pressure path.

[0304] 5.4.1.3 Pressure generator

[0305] In one aspect of the present technology, the pressure generator 4140 that generates an air flow or supply at a positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers housed within a volute. The blower can deliver an air supply at a speed of, for example, up to about 120 liters per minute, at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other aspects up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, which are hereby incorporated by reference in their entirety: U.S. Patent No. 7,866,944, U.S. Patent No. 8,638,014, U.S. Patent No. 8,636,479, and PCT Patent Application Publication WO2013 / 020167.

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

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

[0308] 5.4.1.4 Transducer(s)

[0309] The transducer may be provided inside or outside the RPT device. An external transducer may be arranged, for example, on the air circuit or may form part of the air circuit (e.g., the patient interface). The external transducer may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that sends or moves data to the RPT device).

[0310] 5.4.2 RPT Device Electrical Components

[0311] 5.4.2.1 Power Supply

[0312] The power supply 4210 may be disposed inside or outside the external housing 4010 of the RPT device 4000.

[0313] In one form of the present technology, the power supply 4210 supplies power only to the RPT device 4000. In another form of the present technology, power is provided from the power supply 4210 to both the RPT device 4000 and the humidifier 5000.

[0314] 5.4.2.2 Input Device

[0315] In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials that enable a human to interact with the device. The buttons, switches, or dials can be physical devices or software devices that can be accessed via a touch screen. The buttons, switches, or dials may be physically connected to the external housing 4010 in one form, or may wirelessly communicate with a receiver electrically connected to a central controller in another form.

[0316] 5.4.2.3 Optional Output Devices including Displays and Alarms

[0317] The output devices according to the present technology can take one or more forms of visual, audio, and tactile units. The visual display can be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0318] 5.5 Air Circuit

[0319] An air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged such that an air flow moves between two components (e.g., the RPT device 4000 and the patient interface 3000) during use.

[0320] Specifically, the air circuit 4170 can be in fluid connection with the outlet of the pneumatic block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there can be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0321] In some forms, the air circuit 4170 can include one or more heating elements configured to heat the air in the air circuit (e.g., for maintaining or increasing the air temperature). The heating element can take the form of a heating wire circuit and can include one or more transducers (e.g., a temperature sensor). In one form, the heating wire circuit can be wound helically around the axis of the air circuit 4170. The heating element can communicate with a controller (e.g., a central controller). An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent Application No. 8,733,349. The entire disclosure of this document is incorporated herein by reference.

[0322] 5.6 Humidifier

[0323] 5.6.1 Overview of the Humidifier

[0324] In one form of the technology, a humidifier 5000 is provided for varying the absolute humidity of air or gas to be delivered to a patient relative to ambient air (e.g., such as shown in FIGS. 3V and 3W). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and increase the temperature of an air flow before it is delivered to a patient airway.

[0325] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering a humidified air flow. In some configurations as shown in FIGS. 3V and 3W, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.

[0326] 5.6.2 Humidifier Components

[0327] 5.6.2.1 Water Reservoir

[0328] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a fixed amount of liquid (e.g., water) to be evaporated for humidifying the air flow. The water reservoir 5110 may be configured to contain a predetermined maximum amount of water to provide adequate humidification over at least a respiratory therapy session (e.g., overnight sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In other configurations, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building water supply system).

[0329] According to one aspect, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one configuration, the water reservoir 5110 may be configured to facilitate the movement of the air flow along a serpentine path within the reservoir 5110 while the air flow contacts a fixed amount of water within the reservoir 5110.

[0330] According to one configuration, the reservoir 5110 may be laterally removable from the humidifier 5000, for example as shown in FIGS. 3V and 3W.

[0331] The reservoir 5110 can also be configured to suppress liquid discharge from the reservoir 5110 when, for example, the reservoir 5110 is displaced and / or rotated from its normal operating direction (e.g., through any aperture and / or between its sub-components). Since the air flow to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 can also be configured to avoid air pressure loss through leakage and / or flow impedance.

[0332] 5.6.2.2 Conductive part

[0333] According to one arrangement, the reservoir 5110 includes a conductive part 5120 configured to enable efficient heat transfer from the heating element 5240 to a certain amount of liquid in the reservoir 5110. In one form, the conductive part 5120 can be arranged as a plate, although other shapes may also be suitable. All or part of the conductive part 5120 can be composed of a thermally conductive material such as aluminum (e.g., with a thickness of approximately 2 mm (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, appropriate thermal conductivity can be achieved with a lower conductivity material of appropriate geometry.

[0334] 5.6.2.3 Humidifier reservoir dock

[0335] In one form, the humidifier 5000 can include a humidifier reservoir dock 5130 configured to receive the humidifier reservoir 5110 (as shown in Figure 3V). In some arrangements, the humidifier reservoir dock 5130 can include a locking function (e.g., a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130).

[0336] 5.6.2.4 Water level indicator

[0337] The humidifier reservoir 5110 may include a water level indicator 5150 as shown in FIGS. 3V - 3W. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as patient 1000 or caregiver, regarding the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 may include notification of a maximum predetermined amount of water, any portion thereof (e.g., 25%, 50% or 75% or amount (e.g., 200 ml, 300 ml or 400 ml)).

[0338] 5.6.2.5 Heating Element

[0339] In some cases, the heating element 5240 may be provided to the humidifier 5000 that provides heat input to one or more of the amount of water in the humidifier reservoir 5110 and / or the amount of water to the air flow. The heating element 5240 may include a heat generating component such as an electrical resistance heating track. One suitable example of the heating element 5240 is, for example, the layered heating element described in PCT Patent Application Publication No. WO2012 / 171072. The entire content of this document is incorporated herein by reference for all purposes.

[0340] In some forms, the heating element 5240 may be provided into the humidifier base 5006. In the humidifier base 5006, heat may be sent to the humidifier reservoir 5110 mainly by conduction as shown in FIG. 5B.

[0341] 5.7 Glossary

[0342] For the purposes of the disclosure of the present technology, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, other definitions may also apply.

[0343] 5.7.1 General

[0344] Air: In certain forms of the present technology, air may mean the atmosphere, and in other forms of the present technology, air may mean a combination of other breathable gases (e.g., an oxygen-rich atmosphere).

[0345] Atmosphere: In certain forms of the present technology, the term "atmosphere" should be taken to mean (i) outside the treatment system or the patient, and (ii) that which directly surrounds the treatment system or the patient.

[0346] For example, the ambient humidity for a humidifier can be the humidity of the air that directly surrounds the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may be different from the humidity outside the room where the patient is sleeping.

[0347] In another example, the ambient pressure can be the pressure directly surrounding or outside the body.

[0348] In certain forms, the ambient (e.g., acoustic) noise can be considered the background noise level in the room where the patient is located, other than the noise generated from, for example, the RPT device or the mask or patient interface. The ambient noise can be generated from sources outside the room.

[0349] Auto Positive Airway Pressure (APAP) Therapy: A form of CPAP therapy that can automatically adjust the treatment pressure between a minimum and a maximum, for example, in response to the presence or absence of signs of SDB during the breathing cycle.

[0350] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the treatment pressure is substantially constant throughout the patient's breathing cycle. In some forms, the pressure at the airway inlet rises slightly during exhalation and drops slightly during inhalation. In some forms, the pressure varies between different breathing cycles of the patient (e.g., increased in response to detection of signs of partial upper airway obstruction and reduced in the absence of notification of partial upper airway obstruction).

[0351] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. The flow rate can refer to the instantaneous amount. In some cases, when referring to the flow rate, it may refer to a scalar quantity (i.e., a quantity having only magnitude). In other cases, when referring to the flow rate, it may refer to a vector quantity (i.e., a quantity having both magnitude and direction). The flow rate may be given the symbol Q. The "flow rate" may also be abbreviated as "flow" for simplicity.

[0352] In an example of a patient's breathing, the flow rate can be nominally positive pressure with respect to the inhalation portion of the patient's breathing cycle and thus negative with respect to the exhalation portion of the patient's breathing cycle. The total flow rate Qt is the flow rate of air exiting the RPT device. The ventilation flow rate Qv is the flow rate of air exiting through the ventilation holes to allow the outflow of the exhaled gas. The leakage flow rate Ql is the flow rate of leakage from the patient interface system or other locations. The breathing flow rate Qr is the flow rate of air received in the patient's respiratory system.

[0353] Humidifier: The term "humidifier" is construed to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H20) vapor to an air flow to improve a patient's medical breathing condition.

[0354] Leakage: The term "leakage" is taken as an unintended air flow. In one example, leakage can occur due to an incomplete seal between the mask and the patient's face. In another example, leakage can occur at the ambient elbow.

[0355] Noise conduction (acoustic): In this document, conduction noise refers to noise conveyed to the patient through an air pressure path (e.g., an air circuit and the patient interface and the air within it). In one form, conduction noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0356] Noise emission (acoustic): In this document, the emitted noise refers to the noise conveyed to the patient by the surrounding air. In one form, the emitted noise can be quantified by measuring the acoustic power / pressure level of the object according to ISO3744.

[0357] Noise ventilation (acoustic): In this document, the ventilation noise refers to the noise generated by the air flow through any ventilation (e.g., ventilation holes in the patient interface).

[0358] Patient: A person who has or does not have a respiratory disease.

[0359] Pressure: Force per unit area. Pressure can be expressed and measured in various units (e.g., cmH2O, g-f / cm 2 , and hectopascal). 1 cmH2O is equal to 1 g-f / cm 2 , and approximately 0.98 hectopascal. In this specification, unless otherwise specified, pressure is given in the unit of cmH2O.

[0360] The symbol Pm is assigned to the pressure in the patient interface, and the symbol Pt is assigned to the treatment pressure that represents the target value to be achieved by the mask pressure Pm at the current time.

[0361] Respiratory pressure therapy (RPT): The addition of an air supply to the airway inlet at a treatment pressure that is typically positive pressure with respect to the atmosphere.

[0362] Ventilator: A mechanical device that provides pressure assistance when the patient performs part or all of the breathing motion.

[0363] 5.7.1.1 Materials

[0364] Silicone or silicone elastomer: A synthetic rubber. As used herein, when referring to silicone, it refers to liquid silicone rubber (LSR) or compression molding silicone rubber (CMSR). As one form of commercially available LSR, there is SILASTIC manufactured by Dow Corning (included in the product group sold under this trademark). Another LSR manufacturer is Wacker. Unless otherwise stated, the Shore A (or Type A) indentation hardness of the exemplary form of LSR, when measured by ASTM D2240, is about 35 to about 45.

[0365] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0366] 5.7.1.2 Mechanical Properties

[0367] Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0368] Elastic: Substantially all energy is released during unloading. For example, it includes certain silicones and thermoplastic elastomers.

[0369] Hardness: The ability of a material to resist deformation of itself (e.g., as described by the Young's modulus or the indentation hardness scale measured on a standardized sample size). · "Soft" materials may include silicone or thermoplastic elastomer (TPE), and can be easily deformed, for example, under finger pressure. · "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and cannot be easily deformed, for example, under finger pressure.

[0370] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, tension, bending or torsion). A structure or component may provide different resistance in different directions.

[0371] Flaccid structure or component: A structure or component that changes (e.g., bends) its shape within a relatively short period (e.g., 1 second) when supported under its own weight.

[0372] Rigid structure or component: A structure or component that undergoes substantially no shape change when subjected to the loads typically encountered during use. As an example of such an application, a patient interface may be set up and maintained in a sealed manner against a patient airway inlet under a pressure load of, for example, approximately 20 to 30 cmH2O.

[0373] As one example, an I-beam may include different bending rigidities (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component may be flaccid in a first direction and rigid in a second direction.

[0374] 5.7.2 Respiratory cycle

[0375] Apnea: According to some definitions, apnea is said to occur when a flow below a predetermined threshold persists for a continuous period, for example, 10 seconds. Obstructive apnea is said to occur when, despite the patient's effort, airflow is not permitted due to some airway obstruction. Central apnea refers to a state in which apnea is detected due to a decrease or absence of respiratory effort despite the airway being open. Mixed apnea refers to a state in which a decrease or absence of respiratory effort occurs simultaneously with airway obstruction.

[0376] Respiratory rate: The patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0377] Duty cycle: The ratio of the inspiratory time Ti to the total respiratory time Ttot.

[0378] Effort (respiratory): Respiratory effort is said to refer to the movement performed by the spontaneous breathing of a person attempting to breathe.

[0379] Expiratory portion of the respiratory cycle: The period from the start of the expiratory flow to the start of the inspiratory flow.

[0380] Flow limitation: Flow limitation is interpreted as a situation in a patient's respiration where an increase in the patient's effort does not cause a corresponding increase in the flow. When flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. When flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0381] Types of waveforms of flow-limited inspiration: (i) Flattening: After an ascent, a relatively flat portion is followed by a descent. (ii) M-shaped: Having one local peak at the rise and one local peak at the fall, with a relatively flat portion between these two peaks. (iii) Chair-shaped: Having a single local peak that occurs in the rising portion, followed by a relatively flat portion. (iv) Inverse chair-shaped: A single local peak follows a relatively flat portion, and this peak occurs in the falling portion.

[0382] Hypopnea: According to some definitions, hypopnea means a decrease in flow rather than an interruption of flow. In one form, when a decrease in flow below a threshold velocity continues over a duration, it is said that hypopnea has occurred. When hypopnea is detected due to a decrease in respiratory effort, it is said that central hypopnea has occurred. In one form in adults, any of the following may occur and be regarded as hypopnea: (i) A 30% decrease in the patient's respiration for at least 10 seconds + associated 4% desaturation, or, (ii) A decrease in the patient's respiration (less than 50%) that continues for at least 10 seconds and is associated with at least 3% desaturation or arousal occurs.

[0383] Hyperpnea: The flow increases to a level higher than the normal flow.

[0384] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0385] Patency (airway): The degree to which the airway is open or the range over which the airway is open. Airway patency is an opening. Quantification of airway patency can be performed, for example, with a value (1) indicating patency and a value (0) indicating closure (obstruction).

[0386] Positive end-expiratory pressure (PEEP): A pressure that exceeds the atmosphere in the lungs and exists at the end of exhalation.

[0387] Peak flow (Qpeak): The maximum flow value in the inspiratory portion of the respiratory flow waveform.

[0388] Respiratory gas flow, air flow, patient air flow, respiratory gas air flow (Qr): These terms can be understood to refer to the estimation of the respiratory air flow of an RPT device and are used in contrast to the "true respiratory flow" or "true respiratory gas flow", which is the actual respiratory flow of the patient, usually expressed in liters per minute.

[0389] Tidal volume (Vt): The amount of air inhaled or exhaled during normal breathing without extra effort.

[0390] (Inspiration) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0391] (Expiration) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0392] (Total) time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0393] Typical recent ventilation: The ventilation value (i.e., the degree of tendency of the center of the most recent values of ventilation) for which the most recent values of ventilation Vent over a given time scale tend to cluster.

[0394] Upper airway obstruction (UAO): Includes both partial and total upper airway obstruction. It may be associated with a state of flow limitation where flow may increase slightly or decrease along with an increase in the pressure difference across the upper airway (Starling resistor behavior).

[0395] Ventilation (Vent): Measurement of the rate of gas exchange performed by a patient's respiratory system. The measurement of ventilation may include one or both of the inspiratory and expiratory flows per unit time. When expressed as volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation may simply be given as volume and is understood as volume per minute.

[0396] 5.7.3 Ventilation

[0397] Adaptive servo-ventilator (ASV): A servo-ventilator with a changeable rather than a fixed target ventilation. The changeable target ventilation can be learned from some characteristics of the patient (e.g., the patient's respiratory characteristics).

[0398] Backup rate: A parameter of the ventilator that establishes the minimum respiratory rate (typically, the number of breaths per minute) delivered from the ventilator to the patient (when not triggered by spontaneous breathing efforts).

[0399] Cycle: The end of the inspiratory phase of the ventilator. When delivering breaths from the ventilator to a patient who is breathing spontaneously, at the end of the inspiratory portion of the respiratory cycle, the ventilator is said to cycle to stop breath delivery.

[0400] Expiratory positive airway pressure (EPAP): The baseline pressure to which a pressure that varies within the breath is added for the generation of the desired mask pressure that the ventilator attempts to achieve at a given time.

[0401] End-expiratory pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory portion of a breath. If the pressure waveform template Π(Φ) has a value of zero at the end of expiration (i.e., Π(Φ) = 0 when Φ = 1), the EEP is equal to the EPAP.

[0402] Inspiratory positive airway pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of a breath.

[0403] Pressure assist: A number indicating the pressure increase during ventilator inspiration compared to ventilator expiration, mainly meaning the pressure difference between the maximum value during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure assist means the difference that the ventilator attempts to achieve (rather than the difference that the ventilator actually achieves).

[0404] Servo ventilator: A ventilator with patient ventilation and target ventilation that adjusts the pressure assist level to bring the patient ventilation closer to the target ventilation.

[0405] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the start of a breath of a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined period, the device automatically starts breath delivery.

[0406] Swing: A term corresponding to pressure assist.

[0407] Trigger: When a ventilator delivers a breath of air to a spontaneously breathing patient, the ventilator is said to be triggered to deliver the breath when the patient himself / herself starts the inspiratory portion of the breathing cycle.

[0408] Typical recent ventilation: The typical recent ventilation Vtyp is a range of values over a certain predetermined time scale where recent ventilation measurements tend to cluster. For example, a measurement of the central tendency of ventilation measurements over the recent history can be an appropriate value for the typical recent ventilation.

[0409] 5.7.4 Anatomical Structure

[0410] 5.7.4.1 Anatomical Structure of the Face

[0411] Alar: The outer wall or "wing" of each nostril (plural: alar)

[0412] Alare: The outermost point on the alar of the nose.

[0413] Alar curvature (or alar apex) point: The rearmost point on the curvilinear reference line of each alar, visible at the crease formed by the junction of the alar and the cheek.

[0414] Auricle: The entire visible part of the ear.

[0415] (Nasal) Skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0416] (Nasal) Cartilage Skeleton: The nasal cartilage skeleton includes the septal cartilage, the lateral cartilage, the major cartilage, and the minor cartilage.

[0417] Columella: A skin flap that separates the nostrils and extends from the tip of the nose to the upper lip.

[0418] Columella Angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt horizontal while intersecting the subnasal point.

[0419] Frankfurt Horizontal Plane: A line extending from the lowest point on the orbital margin to the auricular point on the left ear. The auricular point is the deepest point from the upper notch to the tragus of the auricle.

[0420] Glabella: Located in the soft tissue, the most prominent point on the mid-sagittal of the frontal region.

[0421] Lateral Nasal Cartilage: A generally triangular plate of cartilage. Its upper peripheral edge is attached to the nasal bone and the frontal process of the maxilla, and its lower peripheral edge is connected to the major alar cartilage.

[0422] Greater alar cartilage: A plate of cartilage that is located inferior to the lateral nasal cartilage. It curves around the anterior part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane that includes three or four alar minor cartilages.

[0423] Nostril (Naris): Generally an elliptical wing-shaped aperture that forms the entrance to the nasal cavity. The singular form of nostril is naris. These nostrils are separated by the nasal septum.

[0424] Nasolabial groove or nasolabial fold: A fold or groove in the skin that extends from each side of the nose to the corner of the mouth, separating the cheek from the upper lip.

[0425] Nasolabial angle: The angle between the columella and the upper lip, intersecting at the subnasale point.

[0426] Lower ear attachment point: The lowest point of attachment of the auricle to the facial skin.

[0427] Upper ear attachment point: The highest point of attachment of the auricle to the facial skin.

[0428] Tip of nose point: The most prominent point or tip of the nose, which can be identified in a side view of the remaining part of the head portion.

[0429] Philtrum: A midline groove that extends from the inferior border of the nasal septum to the upper part of the lip in the upper lip region.

[0430] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0431] (Nasal) Ridge: The nasal ridge is a midline elevation of the nose that extends from the sellion to the tip of nose point.

[0432] Sagittal plane: A vertical plane that extends from the front (anterior) to the back (posterior), dividing the body into a right and a left half.

[0433] Sellion: The most concave point on the soft tissue, located on the region of the fronto-nasal suture.

[0434] Septal cartilage (nose): The septal cartilage is part of the septum and divides the front part of the nasal cavity.

[0435] Lowest alar point: The point at the lower margin of the alar base, where the alar base joins the skin of the upper (superior) lip.

[0436] Subnasale: The point located on the soft tissue where the columella joins the upper lip in the median sagittal.

[0437] Sublabiale: The most concave point in the midline of the lower lip between the midpoint of the lower lip and the soft tissue pogonion.

[0438] 5.7.4.2 Anatomical structure of the skull

[0439] Frontal bone: The frontal bone includes the frontal squama, which is a large vertical part corresponding to the region known as the forehead.

[0440] Mandible: The mandible forms the lower jaw. The gonion is a bony prominence of the jaw and forms the jaw.

[0441] Maxilla: The maxilla forms the upper jaw and is located below the lower jaw and below the orbit. The frontal process of the maxilla projects upward by the side of the nose and forms part of its outer boundary.

[0442] Nasal bone: The nasal bones are two small rectangular bones, which vary in size and shape from person to person. The nasal bones are arranged side by side in the middle and upper parts of the face, and their junction forms the "bridge" of the nose.

[0443] Nasion: The intersection of the frontal bone and the two nasal bones, which is a concave area directly provided between the eyes and the upper side of the nose bridge.

[0444] Occipital bone: The occipital bone is located at the back and lower part of the skull. The occipital bone includes the foramen magnum, which is an elliptical hole. Through this hole, the intracranial cavity of the skull is connected to the spinal canal. The curved panel behind the foramen magnum is the occipital squama.

[0445] Orbit: A bony cavity in the skull that contains the eyeball.

[0446] Parietal bone: The parietal bones are the bones that, when joined together, form the top and sides of the skull.

[0447] Temporal bone: The temporal bones are located on the base and sides of the skull and support the part of the face known as the temple.

[0448] Zygomatic bone: The two zygomatic bones in the face are located in the upper and outer parts of the face and form the cheek prominences.

[0449] 5.7.4.3 Anatomical Structure of the Respiratory System

[0450] Diaphragm: A sheet of muscle that extends over the lower part of the thorax. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0451] Larynx: The larynx or voice box that houses the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0452] Lung: The respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0453] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the center of the face. The nasal cavity is divided into two by a vertical fin called the nasal septum. There are three horizontal extensions called nasal turbinates or nasal conchae on the sides of the nasal cavity. The nose is at the front of the nasal cavity, and the back connects to the nasopharynx through the posterior nares.

[0454] Pharynx: The part of the throat located directly below (inferior) the nasal cavity and above the esophagus and larynx. The pharynx has traditionally been divided into the following three parts: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (midpharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0455] 5.7.5 Patient Interface

[0456] Anti - asphyxia valve (AAV): A component or sub - assembly of the mask system that reduces the risk of excessive CO2 re - breathing by the patient through an opening to the atmosphere in a fail - safe manner.

[0457] Elbow: The elbow is an example of a structure that directs the axis of the air flow moving inside and changes the direction through an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The elbow can have a substantially circular cross - section. In another form, the elbow can have an elliptical or rectangular cross - section. In a particular form, the elbow can be rotatable, for example, about 360 degrees relative to an engaging component. In a particular form, the elbow can be removable from the engaging component, for example, via a snap connection. In a particular form, the elbow can be assembled to the engaging component via a one - time snap during manufacture while being non - removable by the patient.

[0458] Frame: The frame is taken to mean a mask structure that supports the tensile load between two or more points connecting the headgear. The mask frame can be a non - airtight load - supporting structure in the mask. However, some forms of the mask frame may be airtight.

[0459] Headgear: The headgear is taken to mean a form of positioning and stabilization structure designed to be used on the head. For example, the headgear can include a collection of one or more struts, ties, and supplementary stiffeners configured to position and hold the patient interface at a predetermined position on the patient's face for the delivery of respiratory therapy. Some ties can be formed of a soft, flexible elastic material (e.g., a laminated composite of foam material and fabric).

[0460] Membrane: The membrane is typically taken to mean a thin element and preferably offers substantially no resistance to bending and resistance to stretching and contraction.

[0461] Plenum chamber: The mask plenum chamber is taken to mean a part of the patient interface having a wall that at least partially encloses a volume of space, and the air in the volume is pressurized to exceed atmospheric pressure during use. The shell may form part of the wall of the mask plenum chamber.

[0462] Seal: When used as a noun ("seal"), it can refer to a structure, and when used as a verb ("seal"), it can refer to its effect. Two elements can be constructed and / or arranged such that they "seal" or achieve a "sealing" effect between them without the need for separate "seal" elements themselves.

[0463] Shell: The shell is taken to mean a relatively thin, curved structure having bending, tensile, and compressive rigidity. For example, the curved structural wall of a mask can be a shell. In some forms, the shell can be faceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0464] Reinforcing member: The reinforcing member is taken to mean a structural component designed to increase the stiffness or flexibility of another component in at least one direction.

[0465] Strut: The strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0466] A swivel joint is a sub-assembly of a component, configured to preferably rotate independently and preferably under low torque around a common axis. In one form, the swivel joint can be configured to rotate at an angle of at least 360 degrees. In another form, the swivel joint can be configured to rotate at an angle less than 360 degrees. When used in the context of an air delivery conduit, the sub-assembly of the component preferably includes a pair of combined cylindrical conduits. During use, there is little air leakage from the swivel joint.

[0467] Connector (noun): A structure designed to resist tension.

[0468] Ventilation (noun): A structure that enables air flow to the ambient air inside a mask or conduit, enabling a clinically effective washout of the exhaled gas. For example, in a clinically effective washout, a flow rate of about 10 liters / minute to about 100 liters / minute can be used depending on the mask design and treatment pressure.

[0469] 5.7.6 Shape of the structure

[0470] The product according to this technology can include one or more three-dimensional mechanical structures (e.g., a mask cushion or an impeller). The three-dimensional structure can be limited by a two-dimensional surface. These surfaces can be distinguished using labels to describe the direction, position, function, or some other characteristic of the associated surface. For example, the structure can include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, the cushion structure can include a surface that includes a face (e.g., an outer surface) and a surface that does not include a separate face (e.g., a lower or inner surface). In another example, the structure can include a first surface and a second surface.

[0471] To facilitate the description of the shape and surface of the three-dimensional structure, first consider the cross-section at point p through the surface of the structure. Refer to FIGS. 3B to 3F. FIGS. 3B to 3F show an example of a cross-section at point p on the surface and an example of the resulting planar curve. FIGS. 3B to 3F also show the outward normal vector at p. The outward normal vector at p extends in the direction away from the surface. In some embodiments, this surface is described from the perspective of a fictional small person standing upright on the surface.

[0472] 5.7.6.1 Curvature in One Dimension

[0473] The curvature of the planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., 1 / radius of the circle tangent to the curve at p).

[0474] Positive curvature: When the curve at p bends towards the outward normal, the curvature at that point is taken to have a positive value (when this fictional small person leaves point p, they need to walk uphill). Refer to FIG. 3B (relatively large positive curvature compared to FIG. 3C) and FIG. 3C (relatively small positive curvature compared to FIG. 3B). Such curves are often referred to as concave.

[0475] Zero curvature: When the curve at p is a straight line, the curvature is taken as zero (when this fictional small person leaves point p, they can walk on a horizontal plane that is neither upward nor downward). Refer to FIG. 3D.

[0476] Negative curvature: When the curve at p bends in the direction away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (when this fictional small person leaves point p, they need to walk downhill). Refer to FIG. 3E (relatively small negative curvature compared to FIG. 3F) and FIG. 3F (relatively large negative curvature compared to FIG. 3E). Such curves are often referred to as convex.

[0477] 5.7.6.2 Curvature of a Two-Dimensional Surface

[0478] The description of the shape at a given point on a two-dimensional surface according to this technique may include a plurality of vertical cross-sections. The plurality of cross-sections may cut the surface in a plane including the outward normal (the "normal plane"), and each cross-section may be taken in a different direction. As a result of each cross-section, a planar curve with a corresponding curvature is obtained. The different curvatures at that point may have the same sign or different signs. The curvatures at that point each have a magnitude (e.g., relatively small). The planar curves in FIGS. 3B-3F may be examples of such a plurality of cross-sections at a particular point.

[0479] Principal curvatures and directions: The directions of the normal planes in which the curvature of the curve takes its maximum and minimum values are called the principal directions. In the embodiments of FIGS. 3B-3F, since the maximum curvature occurs in FIG. 3B and the minimum occurs in FIG. 3F, FIGS. 3B and 3F are cross-sections in the principal directions. The principal curvatures at p are the curvatures in the principal directions.

[0480] Region of the surface: A set of connected points on the surface. This set of points within the region may have similar characteristics (e.g., curvature or sign).

[0481] Saddle region: A region in which the principal curvatures at each point have opposite signs (i.e., one positive and the other negative) depending on the direction in which an imaginary person walking on an uphill or downhill slope would face.

[0482] Dome region: A region in which the principal curvatures at each point have the same sign (both positive ("concave dome") or both negative ("convex dome")).

[0483] Cylindrical region: A region in which one principal curvature is zero (or zero within manufacturing tolerances, for example), and the other principal curvature is non-zero.

[0484] Planar region: A region of the surface in which both principal curvatures are zero (or zero within manufacturing tolerances, for example).

[0485] Edge of a surface: The boundary or limit of a surface or region.

[0486] Path: In certain embodiments of the present technology, "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve on a surface from f(0) to f(1)). In certain embodiments of the present technology, "path" can be described, for example, as a route or course that includes a set of points on a surface. (The path of a fictional person is where one walks on a surface and is similar to a garden path).

[0487] Path length: In certain embodiments of the present technology, "path length" is taken to refer to the distance from f(0) to f(1) along a surface (i.e., the distance along a path on a surface). There can be more than one path between two points on a surface, and such paths can have different path lengths. (The path length of a fictional person is the distance walked along a path on a surface).

[0488] Straight-line distance: The straight-line distance is the distance between two points on a surface without considering the surface. On a planar region, there is a distance on the surface edge that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there may not exist a path that has the same path length as the straight-line distance between two points. (For a fictional person, the straight-line distance corresponds to the "distance a crow flies").

[0489] 5.7.6.3 Space curve

[0490] Space curve: Unlike a plane curve, a space curve does not necessarily exist within any specific plane. A space curve can be regarded as a one-dimensional piece of three-dimensional space. A fictional person walking along the strand of a DNA helix is walking along a space curve. A typical human left ear contains a left-handed helix (see Fig. 3Q). A typical human right ear contains a right-handed helix (see Fig. 3R). Fig. 3S shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or a turbine blade) can follow a space curve. Generally, a space curve can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of the manner in which a curve deviates from a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized with respect to the tangent vector, normal vector, and binormal vector at that point.

[0491] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies a direction and a magnitude from that point. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional person is flying along a curve and falls out of their vehicle at a particular point, the direction of the tangent vector is the direction in which the person should be moving.

[0492] Unit normal vector: When a fictional person is moving along a curve, the tangent vector itself changes. The unit vector that points in the same direction as the direction in which the tangent vector is changing is called the unit principal normal vector. This is perpendicular to the tangent vector.

[0493] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (e.g., see Fig. 3P) or, alternatively, the left-hand rule (Fig. 3O).

[0494] Contact plane: The plane containing the unit tangent vector and the unit principal normal vector. See Figs. 3O and 3P.

[0495] Torsion of a space curve: The torsion at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. This measures the degree of deviation from the osculating plane of the curve. The torsion of a space curve lying in a plane is zero. When the deviation from the osculating plane of a space curve is relatively small, the magnitude of the torsion of that space curve is relatively small (e.g., a gently sloping helical path). When the deviation from the osculating plane of a space curve is relatively large, the magnitude of the torsion of that space curve is relatively large (e.g., a steeply sloping helical path). Referring to FIG. 3S, since T2 > T1, the magnitude of the torsion near the top coil of the helix in FIG. 3S is greater than the magnitude of the torsion of the bottom coil of the helix in FIG. 3S.

[0496] Referring to the right - hand rule of FIG. 3P, a space curve that bends in the direction of the right - hand binormal can be regarded as having a positive torsion in the right - hand direction (e.g., a right - hand helix as shown in FIG. 3S). A space curve that faces away from the right - hand binormal direction can be regarded as having a negative torsion of the right - hand (e.g., a left - hand helix).

[0497] Similarly, referring to the left - hand rule (see FIG. 3O), a space curve that faces in the direction of the left - hand binormal can be regarded as having a positive torsion of the left - hand (e.g., a left - hand helix). Thus, the positive direction of the left - hand corresponds to the negative direction of the right - hand. Refer to FIG. 3T.

[0498] 5.7.6.4 Holes

[0499] A surface can have one - dimensional holes (e.g., holes bounded by a planar curve or a space curve). In the case of a thin - walled structure (e.g., a membrane) containing holes, this structure can be described as having one - dimensional holes. For example, refer to the state where the one - dimensional holes in the surface of the structure shown in FIG. 3I are bounded by a planar curve.

[0500] The structure can have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the inner surface of the tire. In another embodiment, a bladder with a cavity for air or gel can have a two-dimensional hole. See, for example, the cushion of Figure 3L and the exemplary cross-sections of Figure 3L in Figures 3M and 3N where the inner surface bounding the two-dimensional hole is shown. In yet another embodiment, a conduit can include a one-dimensional hole (e.g., at its inlet or its outlet) and can include a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole bounded by a surface as shown through the structure of Figure 3K and as illustrated.

[0501] 5.8 Other Considerations

[0502] Part of the disclosure of this patent document contains content that is given copyright protection. The copyright owner has no objection if anyone reproduces this patent document or this patent disclosure by fax, provided it is for the purpose of what is described in the patent files or records of the Patent Office, but retains all copyrights for other purposes.

[0503] Unless otherwise clear from the context and unless a range of values is provided, it is understood that each intervening value between the lower limit of one-tenth of the unit of the lower limit, between the upper and lower limits of the range, and any other recited value or intervening value in the recited range of the technology is encompassed by the technology. Even if the upper and lower limits of these intervening ranges independently included within the intervening range particularly exceed the limitations in the recited range, they are still encompassed by the technology. If the recited range includes one or both of these limitations, ranges exceeding either or both of these recited limitations are also encompassed by the technology.

[0504] Furthermore, when a value (singular or plural) is embodied as part of the technology herein, unless otherwise specified, it is understood that such value can be approximated and such value can be used to any appropriate significant digit to the extent permitted or required by the practical technical implementation.

[0505] Unless otherwise noted, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described in this specification can be used in the practice or testing of this technology, only a limited number of exemplary methods and materials are described herein.

[0506] Although specific materials are described as being preferably used in the construction of components, obvious alternative materials with similar properties can be used as substitutes. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and can be manufactured either collectively or individually.

[0507] As used in this specification and the appended claims, note that the singular forms "a", "an", and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0508] All of the publications described herein are hereby incorporated by reference for their disclosure and description of the methods and / or materials that are the subject of these publications. The publications described herein are provided only for their disclosure prior to the filing date of this application. Nothing in this specification should be construed as an admission that the technology described herein is not prior art to such publications due to the priority of prior patents. Further, the dates of the publications described may be different from the actual publication dates and may need to be individually verified.

[0509] The terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that the recited elements, components, or steps can be present, utilized, or combined with other elements, components, or steps not expressly recited.

[0510] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found throughout the present disclosure or the claims. These headings should not be used in the interpretation of the claims or the scope of the limitations of the claims.

[0511] Although the techniques in this specification have been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, the terms and symbols may indicate specific details that are unnecessary for the implementation of the technology. For example, the terms "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any order and are used to distinguish separate elements. Further, when describing or exemplifying the process steps in this method, they may be presented in an ordered manner, but such an order is unnecessary. Those skilled in the art will recognize that such an order can be changed and / or that the actions can be performed simultaneously or even more synchronously.

[0512] Therefore, it should be understood that numerous variations are possible in the exemplary embodiments without departing from the spirit and scope of the technology, and other arrangements can be devised.

Description of Reference Signs

[0513] 5.9 List of Reference Signs 1000 Patient 1100 Roommate 3000 Patient Interface 3100 Seal Forming Structure 3105 Sealing Surface 3110 Connecting Member 3111 End 3115 Outer Periphery 3120 Tubular Structure 3125 Sealing Flap 3130 Thick Portion 3135 Thin Portion 3140 Hinge structure 3145 Mounting part 3150 Flap 3155 Rib 3160 Flap 3165 Connection point 3170 Angle 3175 Region 3175A Region 3175B Region 3175C Region 3175D Region 3175E Region 3175F Region 3200 Plenum chamber 3210 Edge 3220 Peripheral edge 3300 Structure 3400 Ventilation 3600 Connection port 3700 Forehead support part 3800 Cushion assembly 3810 Cushion 3810 Foam cushion 3812 Flexible support clip 3814 Second clip 3816 Mask shell 4000 RPT device 4170 Air circuit 5000 Humidifier 6000 Cushion assembly 6005 Shell 6010 Seal formation structure 6010A Region 6010B Region 6010C Region 6010D Region 6010E Region 6010F Region 6015 Support structure 6020 Central opening 6025 First end 6030 Second end 6035 Left side 6040 Right side 6045 Sagittal plane 6050 Line 6055 First contact point 6060 Second contact point 6065 Closed path 6070 Open path 6075 Flange part 6080 Base 6085 Frame

Claims

1. A cushion assembly for 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 positive pressure continuously with respect to ambient air pressure, the patient interface being configured to maintain a therapeutic pressure in the range of about 4 cmH ２ O to about 30 cmH ２ O during the entire patient breathing cycle during patient sleep in use, such that sleep disordered breathing is improved, the cushion assembly comprising an elastomeric support portion, an elastomeric seal-forming structure supported by the elastomeric support portion and shaped to be bisected by a sagittal plane including a tangent to the elastomeric seal-forming structure at an upper contact point and a lower contact point, wherein the elastomeric support portion is more rigid than the elastomeric seal-forming structure, a chamber defined by the elastomeric support portion and the elastomeric seal-forming structure, the elastomeric seal-forming structure includes an inner surface forming a boundary of the chamber and an outer surface opposite the inner surface, the elastomeric seal-forming structure includes a first compliant region including an upper contact point and a second compliant region separated from the first compliant region by a support region that is more rigid than the first and second compliant regions, the high-rigidity support region extends to the elastomeric support portion and is anchored by the elastomeric support portion, a cushion assembly, wherein at each point within the rigid support region, when the outer surface has a positive curvature, the inner surface has a negative curvature, and when the outer surface has a negative curvature, the inner surface has a positive curvature.

2. The cushion assembly according to claim 1, wherein the support region becomes more rigid as it approaches the elastomeric support portion.

3. The cushion assembly according to any one of claims 1 to 2, wherein the support region is configured to reduce wrinkles in the first compliant region when a compressive force is applied to the first compliant region.

4. The cushion assembly according to any one of claims 1 to 3, wherein the first compliant region extends to the elastomeric support portion.

5. The cushion assembly according to any one of claims 1 to 4, wherein the second compliant region extends to the elastomeric support portion.

6. The cushion assembly according to any one of claims 1 to 5, wherein the rigidity of the elastomeric seal-forming portion within the second compliant region increases as it approaches the elastomeric support portion.

7. The cushion assembly according to any one of claims 1 to 6, wherein the second compliant region transitions into a loop anchored to the elastomeric support portion.

8. The cushion assembly according to claim 7, wherein the elastomer wall thickness of the loop increases as it approaches the elastomer support portion.

9. The cushion assembly according to any one of claims 1 to 8, wherein the elastomer seal forming portion includes a third compliant region including the lower contact point.

10. The cushion assembly according to claim 9, wherein the first compliant region and the third compliant region have the same rigidity.

11. The cushion assembly according to any one of claims 9 and 10, wherein the rigidity of the elastomer seal forming portion is invariant within a continuous portion of the elastomer seal forming structure extending from the third compliant region to the first compliant region.

12. The cushion assembly according to claim 11, wherein the continuous portion of the elastomer seal forming structure includes a part of the second compliant region.

13. The cushion assembly according to any one of claims 9 to 12, wherein the elastomer seal forming structure further includes an intermediate support region and a side support region disposed between the second compliant region and the third compliant region.

14. The cushion assembly according to claim 13, wherein the intermediate support region and the side support region are more rigid than the first and third compliant regions.

15. The cushion assembly according to any one of claims 9 to 14, wherein the third compliant region is curved as it approaches the first compliant region.

16. The cushion assembly according to any one of claims 1 to 15, wherein the depth of the elastomer support portion varies such that the depth of the elastomer support portion is minimized in the first compliant region and the second compliant region.

17. The cushion assembly according to any one of claims 1 to 16, wherein the elastomer support portion includes a pair of pivotable flanges configured to pivot when the elastomer seal forming structure is compressed into the elastomer support portion.

18. The cushion assembly according to any one of claims 1 to 17, wherein the seal forming structure includes a single layer of elastomer material.

19. A patient interface, A cushion assembly according to any one of claims 1 to 18, A rigid shell removably connected to the cushion assembly, A headgear removably attached to the rigid shell, comprising a patient interface.

20. A CPAP system, The patient interface according to claim 19, A flow generator configured to pressurize a gas flow, An air delivery tube configured to deliver the pressurized gas to the patient interface, comprising a CPAP system.

21. A cushion assembly for 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 positive pressure continuously 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 entire patient's breathing cycle during sleep of the patient in use, such that sleep disordered breathing is improved, and the cushion assembly is An elastomeric support portion, An elastomeric seal forming structure supported by the elastomeric support portion and shaped to be bisected by a sagittal plane including a tangent to the elastomeric seal forming structure at an upper contact point and a lower contact point, wherein the elastomeric support portion is more rigid than the elastomeric seal forming structure, comprising an elastomeric seal forming structure, The elastomeric seal forming structure includes a first compliant region including an upper contact point, and a second compliant region separated from the first compliant region by a spring region having an elastomeric wall thickness higher than that of the first and second compliant regions, The spring region is tapered such that the elastomeric wall thickness increases as it approaches the support portion, The spring region has a curved portion extending from the seal forming structure to the support portion, a cushion assembly.

22. A chamber is defined by the elastomeric seal forming structure and the elastomeric support portion, the elastomeric seal forming structure includes an inner surface forming a boundary of the chamber, and the inner surface of the elastomeric seal forming structure is curved within the support region, the cushion assembly according to claim 20.

23. The support region has a positive curvature of the right hand, the cushion assembly according to any one of claims 21 to 22.

24. The support region is configured to reduce wrinkles in the first compliant region when the first compliant region receives a compressive force, the cushion assembly according to any one of claims 21 to 23.

25. The support region extends to and is anchor-fixed to the elastomeric support portion, the cushion assembly according to any one of claims 21 to 24. **Claim 26** The cushion assembly according to any one of claims 21 to 25, wherein the first compliant region extends to the elastomer support portion. **Claim 27** The cushion assembly according to any one of claims 21 to 26, wherein the second compliant region extends to the elastomer support portion. **Claim 28** The cushion assembly according to any one of claims 21 to 27, wherein the elastomer wall thickness of the elastomer seal forming portion in the second compliant region increases as it approaches the elastomer support portion. **Claim 29** The cushion assembly according to any one of claims 21 to 28, wherein the second compliant region changes to a loop anchored to the elastomer support portion. **Claim 30** The cushion assembly according to claim 29, wherein the elastomer wall thickness of the loop increases as it approaches the elastomer support portion. **Claim 31** The cushion assembly according to any one of claims 21 to 30, wherein the elastomer seal forming portion includes a third compliant region including the lower contact point. **Claim 32** The cushion assembly according to claim 31, wherein the first compliant region and the third compliant region have the same elastomer wall thickness. **Claim 33** The cushion assembly according to any one of claims 31 to 32, wherein the elastomer wall thickness of the elastomer seal forming structure is invariant within a continuous portion of the elastomer seal forming structure extending from the third compliant region to the first compliant region. **Claim 34** The cushion assembly according to claim 33, wherein the continuous portion of the elastomer seal forming structure includes a part of the second compliant region. **Claim 35** The cushion assembly according to any one of claims 31 to 34, wherein the elastomer seal forming structure further includes an intermediate support region and a side support region disposed between the second compliant region and the third compliant region. **Claim 36** The cushion assembly according to claim 35, wherein the elastomer wall thickness of the intermediate support region and the side support region is greater than the elastomer wall thickness in the first compliant region and the third compliant region. **Claim 37** The cushion assembly according to any one of claims 31 to 36, wherein the third compliant region is curved as it approaches the first compliant region.

38. The cushion assembly according to any one of claims 21 to 37, wherein the depth of the elastomer support portion varies such that the depth of the elastomer support portion is minimized in the first compliant region and the second compliant region.

39. The cushion assembly according to any one of claims 21 to 38, wherein the elastomer support portion includes a pair of pivotable flanges configured to pivot when the elastomer seal forming structure is compressed into the elastomer support portion.

40. A patient interface, a cushion assembly according to any one of claims 21 to 40, a rigid shell removably connected to the cushion assembly, and a headgear removably attached to the rigid shell.

41. A CPAP system, a patient interface according to claim 40, a flow generator configured to pressurize a gas flow, and an air delivery tube configured to deliver the pressurized gas to the patient interface.

42. A cushion assembly for 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 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 entire sleep breathing cycle during use, such that sleep disordered breathing is improved, and the cushion assembly comprises including an elastomer seal forming structure shaped to be bisected by a sagittal plane having a tangent to the elastomer seal forming structure at upper and lower contact points, a saddle-shaped upper region of the elastomer seal forming structure straddles the sagittal plane and includes an upper contact point, the elastomer seal forming structure transitions from a saddle-shaped region to a dome-shaped upper region offset from the sagittal plane within a cylindrical upper region, and the elastomer wall thickness of the elastomer seal forming structure is thicker within the cylindrical upper region than within the saddle-shaped upper region and the dome-shaped upper region.

43. The cushion assembly according to claim 42, wherein the thick elastomer wall within the cylindrical upper region is configured to reduce wrinkles in the saddle-shaped upper region when the saddle-shaped upper region receives a compressive force.

44. The cushion assembly according to any one of claims 42 to 43, wherein the elastomer wall thickness in the cylindrical upper region increases in the direction of the curvature of the cylindrical upper region.

45. The cushion assembly according to claim 44, wherein the elastomer wall thickness in the domed upper region increases in the same direction as the cylindrical upper region.

46. The cushion assembly according to any one of claims 42 to 45, wherein the elastomer seal forming structure includes a saddle-shaped lower region including the lower contact point.

47. The cushion assembly according to claim 46, wherein the saddle-shaped upper region and the saddle-shaped lower region have the same elastomer wall thickness.

48. The cushion assembly according to any one of claims 46 to 47, wherein the elastomer wall thickness of the elastomer seal forming structure is invariant within a continuous portion of the elastomer seal forming structure extending from the saddle-shaped lower region to the saddle-shaped upper region.

49. The cushion assembly according to any one of claims 46 to 48, wherein the elastomer seal forming structure further includes a domed lower region disposed between the saddle-shaped lower region and the domed upper region.

50. The cushion assembly according to claim 49, wherein the elastomer seal forming structure further includes a cylindrical side region connecting the domed lower region to the domed upper region.

51. The cushion assembly according to claim 50, wherein the elastomer wall thickness of the cylindrical side region and the domed lower region is greater than the elastomer wall thickness in the saddle-shaped upper region and the saddle-shaped lower region.

52. The cushion assembly according to any one of claims 50 to 51, wherein the domed upper region and the cylindrical side region transition to a loop structure that is curved in the direction of the curvature of the cylindrical side region.

53. The cushion assembly according to claim 52, wherein the elastomer wall thickness of the loop structure increases in a direction away from the cylindrical side region.

54. A patient interface, a cushion assembly according to any one of claims 42 to 54, and a rigid shell removably connected to the cushion assembly. A patient interface including a headgear removably attached to the rigid shell. **Claim 55** A CPAP system, comprising the patient interface according to claim 54, a flow generator configured to pressurize a gas flow, and an air delivery tube configured to deliver the pressurized gas to the patient interface. **Claim 56** A cushion assembly for 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 positive pressure continuously with respect to ambient air pressure, the patient interface being configured to maintain a therapeutic pressure in the range of about 4 cmH ２ O to about 30 cmH ２ O during the entire patient's breathing cycle during sleep of the patient in use, such that sleep disordered breathing is improved, the cushion assembly comprising An elastomeric seal forming structure having an inner surface defining at least a part of a boundary of a chamber, the elastomeric seal forming structure having a rear central opening and a front central opening on the side opposite to the rear central opening, the elastomeric seal forming structure including a plurality of closed paths coaxial with the rear central opening. The elastomeric wall thickness of the elastomeric seal forming structure varies along one of the plurality of closed paths. The inner surface of the thicker part of the elastomeric wall along one of the plurality of closed paths is curved in the direction of an open path extending from the rear central opening to the front central opening. The plurality of closed paths includes an innermost path, and along the innermost path, the elastomeric wall thickness of the elastomeric seal forming structure is invariant. **Claim 57** The cushion assembly according to claim 56, wherein the elastomeric seal forming structure includes a plurality of open paths extending from the rear central opening to the front opening, and the elastomeric wall thickness of the plurality of open paths varies. **Claim 58** The cushion assembly according to any one of claims 56 to 57, wherein the elastomeric seal forming structure includes a plurality of open paths extending from the rear central opening to the front opening, and the elastomeric wall thickness of the plurality of open paths is invariant. **Claim 59** The cushion assembly according to any one of claims 56 to 58, further including an elastomeric support portion supporting the elastomeric seal forming structure on the front side of the elastomeric seal forming structure. **Claim 60** The cushion assembly according to claim 59, wherein the elastomeric support portion is more rigid than the elastomeric seal forming structure. **Claim 61** The cushion assembly according to any one of claims 59 to 60, wherein the chamber is defined by the elastomeric support portion and the elastomeric seal forming portion. **Claim 62** The depth of the elastomeric support portion varies, the cushion assembly according to any one of claims 59 to 61.

63. The elastomeric support portion includes a pair of pivotable flanges configured to pivot when the elastomeric seal forming structure is compressed into the elastomeric support structure, the cushion assembly according to any one of claims 59 to 62.

64. A patient interface, The cushion assembly according to any one of claims 56 to 63, A rigid shell removably connected to the cushion assembly, A headgear removably attached to the rigid shell, a patient interface.

65. A CPAP system, The patient interface according to claim 64, A flow generator configured to pressurize a gas flow, An air delivery tube configured to deliver the pressurized gas to the patient interface, a CPAP system.

66. A cushion assembly for 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 positive pressure continuously 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 entire patient breathing cycle during patient sleep in use, such that sleep disordered breathing is improved, the cushion assembly comprising An elastomeric support portion, An elastomeric seal forming structure supported by the elastomeric support portion, wherein the elastomeric support portion is more rigid than the elastomeric seal forming structure, an elastomeric seal forming structure, The elastomeric seal forming structure, A nasal bridge region configured to seal the patient's nasal bridge when the cushion assembly is attached to the patient's face, A compliant region configured to seal the sides of the patient's nose when the cushion assembly is attached to the patient's face, A support region separating the nasal bridge surface from the compliant region, the support region being thicker than the nasal bridge region and the compliant region, a support region, The support region is tapered such that the elastomeric wall thickness of the support region increases as it approaches the support portion, a cushion assembly.

67. The elastomeric seal forming structure and the elastomeric support portion define a chamber, the elastomeric seal forming structure includes an inner surface forming a boundary of the chamber, and the inner surface within the support region is curved, the cushion assembly according to claim 66.

68. The cushion assembly according to any one of claims 66 to 67, wherein the support area is configured to reduce wrinkles in the nasal bridge area when the nasal bridge area receives a compressive force.

69. The cushion assembly according to any one of claims 66 to 68, wherein the support area extends to and is anchor-fixed to the elastomeric support portion.

70. The cushion assembly according to any one of claims 66 to 69, wherein the nasal bridge area extends to the elastomeric support portion.

71. The cushion assembly according to any one of claims 66 to 70, wherein the compliant area extends to the elastomeric support portion.

72. The cushion assembly according to any one of claims 66 to 71, wherein the elastomeric wall thickness of the elastomeric seal forming portion within the compliant area increases as it approaches the elastomeric support portion.

73. The cushion assembly according to any one of claims 66 to 72, wherein the compliant area changes to a loop that is anchor-fixed to the elastomeric support portion.

74. The cushion assembly according to claim 73, wherein the elastomeric wall thickness of the loop increases as it approaches the elastomeric support portion.

75. The cushion assembly according to any one of claims 66 to 74, wherein the elastomeric seal forming portion includes a lip area configured to engage the patient's face above the patient's lips when the cushion assembly is attached to the patient's face.

76. The cushion assembly according to claim 75, wherein the nasal bridge area and the lip area have the same elastomeric wall thickness.

77. The cushion assembly according to any one of claims 75 to 76, wherein the elastomeric wall thickness of the elastomeric seal forming structure is invariant within a continuous portion of the elastomeric seal forming structure extending from the lip area to the nasal bridge area.

78. The cushion assembly according to claim 77, wherein the continuous portion of the elastomeric seal forming structure includes a part of the compliant area.

79. The elastomeric seal forming structure further includes an intermediate support region and a side support region disposed between the compliant region and the lip region, the cushion assembly according to any one of claims 75 to 78.

80. The elastomeric wall thickness of the intermediate support region and the side support region is greater than the elastomeric wall thickness in the nasal bridge region and the lip region, the cushion assembly according to claim 79.

81. The depth of the elastomeric support portion varies such that the depth of the elastomeric support portion is minimized in the nasal bridge region, the cushion assembly according to any one of claims 66 to 80.

82. The elastomeric support portion includes a pair of pivotable flanges configured to pivot when the elastomeric seal forming structure is compressed into the elastomeric support portion, the cushion assembly according to any one of claims 66 to 81.

83. A patient interface, The cushion assembly according to any one of claims 66 to 83, A rigid shell removably connected to the cushion assembly, A headgear removably attached to the rigid shell, a patient interface.

84. A CPAP system, The patient interface according to claim 83, A flow generator configured to pressurize a gas flow, An air delivery tube configured to deliver the pressurized gas to the patient interface, a CPAP system.

85. A cushion assembly for 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 positive pressure continuously with respect to 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 entire patient's breathing cycle during sleep of the patient in use, such that sleep disordered breathing is improved, and the cushion assembly is An elastomeric seal forming structure having an outer surface configured to seal the patient's face when the cushion assembly is attached to the patient's face, the elastomeric seal forming structure having an inner surface facing the outer surface and defining at least a portion of a chamber, an elastomeric seal forming structure, Inside the seal forming structure, there is a central opening configured to receive at least a portion of the patient's nose when the cushion assembly is attached to the patient's face, The seal forming structure includes a plurality of closed paths coaxial with the central opening, The elastomeric wall thickness of the elastomeric seal forming structure varies along one of the plurality of closed paths, The thicker portion of the elastomeric wall along one of the plurality of closed paths has an inner surface facing a chamber that is curved in the direction of an open path extending from a rear central opening to a front central opening. The plurality of closed paths includes an innermost path, and along the innermost path, the elastomeric wall thickness of the elastomeric seal formation structure is invariant, cushion assembly.

86. A patient interface, The cushion assembly according to claim 85, A rigid shell removably connected to the cushion assembly, A headgear removably attached to the rigid shell, comprising a patient interface.

87. A CPAP system, The patient interface according to claim 86, A flow generator configured to pressurize a gas flow, An air delivery tube configured to deliver the pressurized gas to the patient interface, comprising a CPAP system.

88. A cushion assembly for 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 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 entire patient breathing cycle during patient sleep in use, such that sleep disordered breathing is improved, the cushion assembly comprising An elastomeric support portion, An elastomeric seal formation structure supported by the elastomeric support portion and shaped to be bisected by a sagittal plane including tangents to the elastomeric seal formation structure at upper and lower contact points, wherein the elastomeric support portion is more rigid than the elastomeric seal formation structure, an elastomeric seal formation structure, A chamber defined by the elastomeric support portion and the elastomeric seal formation structure, The elastomeric seal formation structure includes an inner surface forming a boundary of the chamber and an outer surface on the opposite side of the (said) inner surface, The elastomeric seal formation structure includes a first compliant region including an upper contact point and a second compliant region separated from the first compliant region by a support region that is more rigid than the first and second compliant regions, The high-rigidity support region extends to the elastomeric support portion and is anchored by the elastomeric support portion, The elastomeric wall thickness in the high-rigidity support region is invariant, cushion assembly.

89. A cushion assembly for 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 with respect to 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 entire patient's breathing cycle during sleep of the patient in use, such that sleep disordered breathing is improved, and the cushion assembly comprises An elastomeric support portion, An elastomeric seal-forming structure that is supported by an elastomeric support portion and is shaped to be bisected by a sagittal plane including a tangent to the elastomeric seal-forming structure at an upper contact point and a lower contact point, wherein the elastomeric support portion is more rigid than the elastomeric seal-forming structure, and the elastomeric seal-forming structure, A chamber defined by the elastomeric support portion and the elastomeric seal-forming structure, and The elastomeric seal-forming structure includes an inner surface that forms a boundary of the chamber and an outer surface on the opposite side of the (said) inner surface, The elastomeric seal-forming structure includes a first compliant region including an upper contact point and a second compliant region separated from the first compliant region by a support region that is more rigid than the first and second compliant regions, The high-rigidity support region extends to the elastomeric support portion and is anchor-fixed by the elastomeric support portion, A cushion assembly in which, at each point of the rigid support region, the curvature of the inner surface follows the curvature of the outer surface.

90. A cushion assembly for a patient interface for delivering a gas flow in a sealed manner to an inlet to a patient's airway, including at least the patient's nostril inlet, at a positive pressure continuously with respect to 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 entire patient breathing cycle during patient sleep in use, such that sleep disordered breathing is improved, and the cushion assembly comprises An elastomeric support portion, and An elastomeric seal-forming structure that is more flexible than the elastomeric support portion, the elastomeric seal-forming structure including a tubular structure having a continuous circumference, and the elastomeric seal-forming structure, A plenum chamber defined by the elastomeric support portion and the elastomeric seal-forming structure, the plenum chamber being configured to receive the positive-pressure pressurized gas, and the tubular structure and the chamber being bounded by a common inner surface of the elastomeric seal-forming structure, and a plenum chamber, and a cushion assembly including the same.

91. A sealing structure for 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 ambient air pressure, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 3 cmH ２ O to about 40 cmH ２ O during the entire patient's breathing cycle during sleep of the patient in use, such that sleep disordered breathing is improved, and the sealing structure is An elastomeric support portion, and An elastomeric seal-forming structure that is more flexible than the elastomeric support portion, the elastomeric seal-forming structure being supported by the elastomeric support portion and including a connection portion extending from an inner surface of the elastomeric seal-forming structure to an inner surface of the elastomeric support portion, and the elastomeric seal-forming structure, A plenum chamber configured to receive the positive-pressure air, the plenum chamber being defined by the elastomeric support portion and the elastomeric seal-forming portion, and a plenum chamber, and The connection part is a sealing structure arranged to withstand the deformation of the seal formation structure in order to prevent a situation where the sealing surface of the seal formation structure is deformed outward by the pressurized gas in the plenum chamber.

92. A cushion assembly for a patient interface for delivering a gas 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 relative to 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 entire patient's breathing cycle during sleep of the patient in use, such that sleep disordered breathing is improved, the cushion assembly comprising An elastomer support part, An elastomer seal formation structure that is more flexible than the elastomer support part, wherein the elastomer seal formation structure extends from a first end to a second end, and the first end is fixed to the elastomer support part, including the elastomer seal formation structure. The second end of the elastomer seal formation structure is a free end and is not attached to any structure except at the point where the elastomer seal formation structure is looped, and the second end is fixed at the location where the elastomer seal formation structure is looped, a cushion assembly.

93. A cushion assembly for a patient interface for delivering a gas 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 relative to ambient air pressure, the patient interface being 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 entire breathing cycle during sleep in use such that sleep disordered breathing is improved, the cushion assembly comprising An elastomer support part, An elastomer seal formation structure that is more flexible than the elastomer support part, A plenum chamber configured to receive the positive pressure air, wherein the plenum chamber is defined by the elastomer support part and the elastomer seal formation part, including the plenum chamber. The first cross-sectional shape of the elastomer seal formation structure is a closed loop, The second cross-sectional shape of the elastomer seal formation structure is open, a cushion assembly.

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