Patient interface

Abstract

To provide new medical equipment used for screening, diagnosis, monitoring, improvement, treatment, or prevention of a respiratory disease.SOLUTION: A patient interface can include: a plenum chamber having a mouth region and a nose region; and a positioning and stabilizing structure configured for generating force to support a seal forming structure above the head of a patient. The plenum chamber can include: a seal forming structure constructed and disposed so as to form the face of the patient and the seal, wherein the nose region thereof includes at least one hole for the nose and the mouth region thereof includes a hole for the mouth; and a shell for supporting the seal forming structure, including one or more plenum chamber inlet ports sized and structured so as to receive an air flow in the treatment pressure for respiration by the patient in the entire respiration cycle of the patient when in use.SELECTED DRAWING: Figure 8

Description

Technical Field

[0001] The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and amelioration of respiratory-related diseases. The present technology also relates to a medical device or apparatus and its use.

[0002] 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 that it is as described in the patent file or record of the Patent Office and for the purpose intended, but retains all copyrights for other purposes.

[0003] (Cross - reference to related applications)

[0004] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 649,376 (filing date: March 28, 2018), and U.S. Provisional Patent Application No. 62 / 731,456 (filing date: September 14, 2018). The entire disclosures of these documents are incorporated herein by reference.

Background Art

[0005] 2.2.1 The human respiratory system and its diseases

[0006] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0007] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The primary function of the lungs is gas exchange, taking oxygen from the air into the venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchi constitute the airways for conduction and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory region. See the following: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0008] A range of respiratory diseases exist. Certain diseases can be characterized by specific occurrences (e.g., apnea, hypopnea, and hyperventilation).

[0009] 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.

[0010] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by occurrences such as closure or obstruction of the upper airway during sleep. This is the result of a combination of an abnormally small upper airway and the normal loss of muscle tone in the tongue region, and the normal loss of the soft palate and posterior oropharyngeal wall during sleep. Due to such a condition, the breathing cessation of affected patients typically lasts for 30 to 120 seconds, and sometimes the breathing stops 200 to 300 times a night. As a result, excessive daytime sleepiness occurs, which can cause cardiovascular diseases and brain damage. This syndrome is a common disease, especially common in middle-aged overweight men, but patients have no awareness of the symptoms. See U.S. Patent No. 4,944,310 (Sullivan).

[0011] 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, CSR 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).

[0012] Respiratory insufficiency is a general term for respiratory disorders and refers to the inability of the lungs to perform adequate oxygen inhalation or adequate CO 2 exhalation. Respiratory insufficiency can include some or all of the following diseases.

[0013] Patients with respiratory insufficiency (a type of respiratory disorder) may experience abnormal shortness of breath during exercise.

[0014] Obesity hypoventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia during wakefulness in the absence of other clear causes of hypoventilation. Symptoms include dyspnea, headache upon waking, and excessive daytime sleepiness.

[0015] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that have certain common characteristics. These include an increased 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.

[0016] Neuromuscular diseases (NMDs) are a broad term encompassing a number of disorders 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 eventually 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 NMDs include increased general debility, swallowing disorders, dyspnea during exertion and at rest, fatigue, drowsiness, headache upon waking, and difficulty with concentration and mood changes.

[0017] 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 kyphoscoliosis 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.

[0018] To treat or improve such conditions, a range of treatments are being used. Additionally, in other aspects, healthy individuals can also benefit from preventive treatment for respiratory diseases. However, these have several drawbacks.

[0019] 2.2.2 Treatment methods

[0020] A variety of therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV)) are used for the treatment of one or more of the above respiratory diseases.

[0021] 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, continuous positive pressure ventilation therapy functions as an air sprint, thereby preventing the closure of the upper airway. Since the treatment of OSA by CPAP therapy can be spontaneous, if such a patient notices one or more of the following regarding the device used for treatment delivery, the patient may choose not to comply with the treatment: discomfort, difficulty in use, high cost, lack of aesthetic appeal.

[0022] Non-invasive ventilation (NIV) provides ventilatory 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 ventilatory 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.

[0023] Invasive ventilation (IV) provides ventilatory 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.

[0024] 2.2.3 Treatment system

[0025] These treatments can be provided by a treatment system or device. Such systems and devices can also be used for screening, diagnosing, or monitoring without treating the disease.

[0026] The treatment system may include a respiratory pressure treatment device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0027] As another form of treatment system, there is a mandibular repositioning device.

[0028] 2.2.3.1 Patient Interface

[0029] The patient interface can be used, for example, to provide an interface to the 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 providing a gas delivery at a sufficient distributed pressure together with the atmospheric pressure for the execution of the therapy (e.g., at a positive pressure of about 10 cmH 2 O). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to promote the delivery of gas supply to the airway at a positive pressure of about 10 cmH 2 O.

[0030] 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 intrusion from higher external pressures and not maintain the internal air at a pressure higher than the ambient.

[0031] Certain masks may not be clinically preferred in this technology (e.g., when the mask blocks the air flow through the nose and only allows the air flow through the mouth).

[0032] In certain masks, it may be uncomfortable or impractical in the present technology when the patient has to insert part of the mask structure into the mouth and create and maintain a seal through the lips.

[0033] Certain masks may be impractical for use during sleep (e.g., when sleeping on the side in bed with the head on a pillow).

[0034] There are multiple challenges in the design of patient interfaces. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout the respiratory therapy period.

[0035] 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 being overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of the wrong size is used, it can lead to a decrease in compliance, comfort, and patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic mask, although tolerable for their original uses, may be unacceptably uncomfortable for wearing over a long period (e.g., several hours). Due to such discomfort, the patient's compliance with the treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0036] CPAP therapy is extremely effective in the treatment of certain respiratory diseases when the patient has consented to the treatment. If the mask is uncomfortable or difficult to use, the patient may not consent to the treatment. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (for example, if it is difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect patient compliance.

[0037] In the case of masks for other uses (for example, pilots), since they may not be suitable for use in the treatment of sleep apnea, masks designed for use in the treatment of sleep apnea may be suitable for other uses.

[0038] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0039] 2.2.3.1.1 Seal-forming structure

[0040] The patient interface may include a seal-forming structure. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0041] The patient interface can be partially characterized according to the design intent of where the seal-forming structure engages the face during use. In one form of the patient interface, the seal-forming structure can include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure can include a single element that surrounds both nostrils during use. Such a single element can be designed to be placed, for example, on the upper lip region and nasal bridge region of the face. In one form of the patient interface, the seal-forming structure can 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 structure can 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.

[0042] A seal-forming structure that may be effective in one region of a patient's face may be inappropriate in another region, for example, due to different shapes, structures, variabilities, and sensitive regions 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.

[0043] A particular seal-forming structure can be designed for mass production such that one design fits a wide range of different face shapes and sizes and is comfortable and effective. To form a seal, it may be necessary to conform one or both of the patient's face shape and the seal-forming structure of the mass-produced patient interface to the extent of any mismatch between them.

[0044] One type of seal-forming structure extends around the perimeter of the patient interface and is intended to seal the patient's face when force is applied to the patient interface while the seal-forming structure is engaged against the patient's face. This seal-forming structure may include an air or fluid-filled cushion or may include a shaped or formed surface of an elastic sealing element composed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inappropriate, a gap may occur between the seal-forming structure and the face, and additional force is required to press the patient interface against the face to achieve a seal.

[0045] Another type of seal-forming structure uses a thin flap seal disposed around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previously described type of seal-forming portion, if the alignment between the face and the mask is not good, additional force may be required to achieve a seal or leakage may occur from the mask. Further, if the shape of the seal-forming structure does not conform to the shape of the patient, creases or buckling may occur in the seal-forming portion during use, causing leakage.

[0046] Another type of seal-forming structure may include friction fit elements inserted into the nostrils, for example, although there are patients who find these seal-forming portions uncomfortable.

[0047] Another form of seal-forming structure may use an adhesive portion to achieve a seal. There are also patients who always find it inconvenient to attach or remove the adhesive portion to their face.

[0048] Disclosures of a range of patient interface seal-forming structure technologies are available in the following patent applications assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785.

[0049] 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.

[0050] ResMed Limited manufactures the following products using nasal pillows: SWIFT® Nasal Pillow Mask, SWIFT® II Nasal Pillow Mask, SWIFT® LT Nasal Pillow Mask, SWIFT® FX Nasal Pillow Mask and MIRAGELIBERTY® Full Face Mask. The following patent applications assigned to ResMed Limited describe embodiments of nasal pillow masks: International Patent Application WO2004 / 073,778 (particularly describing the appearance of ResMed Limited's SWIFT® nasal pillow), U.S. Patent Application No. 2009 / 0044808 (particularly describing the appearance of ResMed Limited's SWIFT® LT nasal pillow); International Patent Applications WO2005 / 063,328 and WO2006 / 130,903 (particularly describing the appearance of ResMed Limited's MIRAGE LIBERTY® Full Face Mask); International Patent Application WO2009 / 052,560 (particularly describing the appearance of ResMed Limited's SWIFT® FX nasal pillow).

[0051] 2.2.3.1.2 Positioning and stabilization

[0052] The seal-forming structure of a patient interface used in positive pressure air therapy is subject to the corresponding forces of air pressure that interfere with the seal. Therefore, various techniques are used to position the seal-forming structure and maintain the seal against the appropriate part of the face.

[0053] In one technique, an adhesive part is used. See, for example, U.S. Patent Application Publication US2010 / 0000534. However, when using an adhesive part, there may be discomfort.

[0054] In another technique, one or more straps and / or stabilization harnesses are used. In the case of a number of such harnesses, one or more of the following apply: poor fit, bulky, uncomfortable and difficult to handle.

[0055] 2.2.3.2 Respiratory Pressure Therapy (RPT) device

[0056] A Respiratory Pressure Therapy (RPT) device can be used individually for the delivery of one or more of the above treatments, or as part of a system, for example by operating the device to generate an air delivery flow to an interface to the airway. This air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0057] 2.2.3.3 Humidifier

[0058] 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 an RPT device and a patient interface, a humidified gas is generated, thus 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 compared to cold air.

[0059] 2.2.3.4 Data management

[0060] For clinical reasons, it may be necessary to obtain data to determine whether a patient for whom respiratory therapy has been prescribed is "compliant" (e.g., whether the patient is following one or more "compliance rules" with their RPT device). As an example of a compliance rule for CPAP therapy, for a patient to be considered compliant, the patient must use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days. To determine a patient's compliance, the 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.

[0061] 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.

[0062] 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.

[0063] 2.2.3.5 Mandibular repositioning

[0064] 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.

[0065] In certain embodiments, the mandibular advancement device may include an upper splint intended to engage or fit with the teeth on the maxilla or maxilla bone and a lower splint intended to engage or fit with the 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.

[0066] 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 change the level of protrusion of the mandible. The dentist can determine the protrusion level according to the mandible, and as a result, the length of the connecting rod is determined.

[0067] There are also MRDs configured to push the mandible forward relative to the maxilla bone, such as ResMed Narval Some MADs, such as the CC (registered trademark) MRD, are designed to hold the mandible in a forward position. This device also reduces or minimizes dental side effects and side effects of the temporomandibular joint (TMJ). Therefore, this device is configured to minimize or avoid any movement of one or more of the teeth.

[0068] 2.2.3.6 Ventilation technology

[0069] Some forms of treatment systems may include a ventilation portion for expelling the exhaled carbon dioxide. This ventilation portion may allow gas flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings).

[0070] This ventilation portion may include an orifice through which gas can flow when the mask is in use. In the case of a number of such ventilation portions, the sound is noisy. In other cases, it may become blocked during use, resulting in insufficient extrusion. In the case of some ventilation portions, for example due to sound or airflow concentration, it may interfere with the sleep of the patient 1000 and the co - sleeper 1100.

[0071] 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.

[0072] Table of noise of conventional masks (ISO17510 - 2:2007, 10 cmH 2 O pressure)

[0073] [Table 1]

[0074] (* Measure only 1 sample at 10 cmH₂O in CPAP mode using the test method specified in ISO3744 2 (measurement)

[0075] List the sound pressure values of various subjects as follows

[0076] [Table 2]

[0077] 2.2.4 Screening, Diagnosis, and Monitoring Systems

[0078] A polysomnogram (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary diseases and typically requires expert clinical staff for system application in many cases. In a PSG, typically 15 to 20 contact sensors are placed on the human body to record various body signals (e.g., electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyography (EMG)). For PSG of sleep disordered breathing, 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 the titration of treatment parameters by a clinician. Therefore, PSG is costly and has low convenience. Screening / diagnosis / monitoring of sleep disordered breathing is particularly unsuitable at home.

[0079] Generally, screening and diagnosis are to identify a disease based on the signs and symptoms of the disease. Usually, screening gives a true / false result indicating whether the patient's SDB requires further investigation, while diagnosis often gives clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the course of a disease can be continued indefinitely. Some screening / diagnosis systems are only suitable for screening / diagnosis, while some can also be used for monitoring.

[0080] Clinical experts can appropriately perform patient screening, diagnosis, or monitoring 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, certain clinical experts may apply different criteria depending on the time.

Summary of the Invention

Means for Solving the Problems

[0081] 3 Brief Description of the Technology

[0082] This technology is related to the provision of medical devices used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0083] The first aspect of this technology is related to a device used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases.

[0084] Another aspect of this technology is related to a method used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory disorders.

[0085] One aspect of a specific form of this technology is to provide a method and / or device for improving patient compliance regarding respiratory treatment.

[0086] Aspects of this technology relate to a patient interface including a plenum chamber comprising a seal-forming structure, a shell, and a positioning and stabilization structure. At least a partially forward wall of the nasal portion of the seal-forming structure includes two lateral support sites, the lateral support sites are each spaced apart laterally, and each lateral support site has a higher resistance to deformation relative to an adjacent portion of the seal-forming structure.

[0087] One aspect of the present technology relates to a patient interface: The patient interface is a plenum chamber that can be pressurized to a therapeutic pressure of at least 6 cmH 2 O exceeding the ambient air pressure throughout the patient's respiratory cycle during use. The plenum chamber has an oral portion and a nasal portion, and the plenum chamber is a seal-forming structure constructed and arranged to form a seal against the area of the patient's face surrounding the entrance to the patient's airway. The nasal portion of the seal-forming structure has at least one nasal aperture configured to deliver the airflow at the therapeutic pressure to the entrance of the patient's nostrils during use. The oral portion of the seal-forming structure has an oral aperture configured to deliver the airflow at the therapeutic pressure to the entrance of the patient's mouth during use. The seal-forming structure is constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use. It includes a seal-forming structure and one or more plenum chamber inlet ports sized and structured to receive the airflow at the therapeutic pressure for the patient's respiration throughout the patient's respiratory cycle during use, and a shell supporting the seal-forming structure. The plenum chamber includes a positioning and stabilization structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The shell is joined to the oral portion of the plenum chamber. The seal-forming structure forms substantially the entire nasal portion. The nasal portion of the plenum chamber includes a rear corner configured to engage the patient's face in the vicinity of the nasolabial groove. At least a partially front wall of the nasal portion of the seal-forming structure includes two lateral support sites, which are spaced apart laterally and each has a higher resistance to deformation relative to the adjacent portion of the seal-forming structure.

[0088] In examples of the two aspects described above, (a) the lateral support portions may each be thicker than the adjacent portions of the seal-forming structure, (b) the lateral support portions may each have a curved upper boundary and may each be substantially fin-shaped, (c) the nose portion of the seal-forming structure may include a central portion configured to seal against the lower peripheral portion of the patient's nose around the patient's nostrils and the patient's upper lip during use, and the central portion may be thinner than the lateral support portions, (d) the nose portion of the seal-forming structure may include an intermediate portion provided between the central portion and the lateral support portions, and the intermediate portion may be thicker than the central portion, (e) the intermediate portion may be thinner than the lateral support portions, (f) the shell may include a rear projection configured to reinforce the seal-forming structure at the base of the nose portion during use, and / or (g) the seal-forming structure may be configured not to engage the patient's face below the chin during use.

[0089] Aspects of the present technology relate to a patient interface that includes a plenum chamber including a seal-forming structure, a shell, and a positioning and stabilization structure. The shell includes two lateral support portions that project upward into at least a portion of the front wall of the nose portion of the seal-forming structure, and the lateral support portions are each spaced apart laterally.

[0090] One aspect of the present technology relates to a patient interface: the patient interface has at least 6 cmH that exceeds ambient air pressure throughout the patient's respiratory cycle during use 2A plenum chamber capable of being pressurized up to a therapeutic pressure of O, the plenum chamber having an oral portion and a nasal portion, the plenum chamber being a seal-forming structure constructed and arranged to form a seal against a region of the patient's face surrounding an inlet to the patient's airway, the nasal portion of the seal-forming structure having at least one nasal aperture configured to deliver an airflow at the therapeutic pressure to an inlet to the patient's nostrils during use, the oral portion of the seal-forming structure having an oral aperture configured to deliver an airflow at the therapeutic pressure to an inlet to the patient's mouth during use, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use, a seal-forming structure, and a shell configured to support the seal-forming structure, the shell having one or more plenum chamber inlet ports sized and structured to receive an airflow at the therapeutic pressure for the patient's respiration throughout the patient's respiratory cycle during use, a plenum chamber including, and a positioning and stabilization structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the shell including two lateral support portions projecting upwardly into at least a partially forward wall of the nasal portion of the seal-forming structure, the lateral support portions being spaced apart laterally from each other.

[0091] In examples of the two above aspects, (a) each of the lateral support portions may have a curved upper boundary, (b) the curvature of the curved upper boundary may substantially match or substantially follow the curvature of the upper peripheral portion of the seal-forming structure, (c) the shell may include two plenum chamber inlet ports, and / or (d) the upper boundary of each of the two plenum chamber inlet ports may be formed by each of the lateral support portions.

[0092] Aspects of the present technology relate to a patient interface including a plenum chamber having one or more walls, a seal-forming structure, one or more plenum chamber inlet ports, and a positioning and stabilization structure. The seal-forming structure includes a central portion configured to seal around the lower periphery of the patient's nose during use, and the seal-forming structure includes an intermediate portion configured to contact the patient's nasal wings during use, the intermediate portion being more rigid than the central portion.

[0093] One aspect of the present technology relates to a patient interface: The patient interface is a plenum chamber for a patient interface, the plenum chamber being pressurizable to a treatment pressure of at least 6 cmH 2 O exceeding ambient air pressure throughout the patient's respiratory cycle during use, the plenum chamber comprising one or more walls at least partially enclosing a constant volume of space, and a seal-forming structure constructed and arranged to form a seal against a region of the patient's face surrounding an inlet to the patient's airway, the seal-forming structure comprising a nasal portion having at least one nasal aperture configured to deliver an air flow at the treatment pressure to an inlet to the patient's nostrils during use, the seal-forming structure comprising an oral portion having an oral aperture configured to deliver an air flow at the treatment pressure to an inlet to the patient's mouth during use, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, a seal-forming structure, and one or more plenum chamber inlet ports sized and structured to receive an air flow at the treatment pressure for the patient's respiration throughout the patient's respiratory cycle during use, a plenum chamber, and a positioning and stabilization structure configured to generate a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, the seal-forming structure including a central portion configured to seal around the lower periphery of the patient's nose during use, the seal-forming structure including an intermediate portion configured to contact the patient's nasal wings during use, the intermediate portion being more rigid than the central portion.

[0094] In examples of the above two aspects, (a) the intermediate portion may include a pair of outer walls of a seal-forming structure that face partially in the intermediate direction and partially upward, (b) the intermediate portion may be configured to withstand folds, (c) the intermediate portion may be configured to limit the formation of a leakage path from the lower peripheral portion of the patient's nose to the surroundings due to folds, (d) the intermediate portion may be thicker than the central portion, and / or (e) the seal-forming structure may be configured not to engage the patient's face under the chin during use.

[0095] Aspects of the present technology relate to a patient interface that includes a plenum chamber including one or more walls, a seal-forming structure, one or more plenum chamber inlet ports sized and structured to receive an airflow at a treatment pressure for the patient's respiration throughout the patient's respiratory cycle, and a positioning and stabilization structure. The seal-forming structure includes a laterally peripheral support site provided at an opposing lateral portion of the oral cavity, the laterally peripheral support site is adjacent to the periphery of the oral aperture, and the laterally peripheral support site is more rigid than the periphery of the oral aperture.

[0096] One aspect of the present technology relates to a patient interface: The patient interface is a plenum chamber for a patient interface, and the plenum chamber has at least 6 cmH exceeding the ambient air pressure throughout the patient's respiratory cycle during use 2It is possible to pressurize up to the therapeutic pressure of O. The plenum chamber includes one or more walls that at least partially enclose a space of a certain volume, and a seal-forming structure that is constructed and arranged to form a seal against the area of the patient's face surrounding the entrance to the patient's airway. The seal-forming structure includes a nasal portion having at least one nasal aperture configured to deliver the airflow at the therapeutic pressure to the entrance of the patient's nostrils during use. The seal-forming structure includes an oral portion having an oral aperture configured to deliver the airflow at the therapeutic pressure to the entrance of the patient's mouth during use. The seal-forming structure is constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use. The plenum chamber further includes one or more plenum chamber inlet ports sized and structured to receive the airflow at the therapeutic pressure for the patient's breathing throughout the patient's respiratory cycle during use. The seal-forming structure includes a peripheral portion of the oral aperture that surrounds at least a majority of the oral aperture configured to surround the patient's mouth during use. The seal-forming structure includes a lateral peripheral support portion provided at opposite lateral sides of the oral aperture. The lateral peripheral support portion is adjacent to the peripheral portion of the oral aperture and is more rigid than the peripheral portion of the oral aperture. The patient interface.

[0097] In examples of the above two aspects, (a) the lateral peripheral support portion may be thicker than the peripheral portion of the oral aperture; (b) the seal-forming structure may include a rearward-facing lateral portion that surrounds a majority of the peripheral portion of the oral aperture, and the rearward-facing lateral portion is thicker than the peripheral portion of the oral aperture; (c) the rearward-facing lateral portion may extend in an intermediate direction to the outermost lateral edge of the oral cavity to form the lateral peripheral support portion, and / or (d) the seal-forming structure may be configured not to engage with the patient's face below the jaw during use.

[0098] Aspects of the present technology relate to a plenum chamber for a patient interface, including one or more walls, one or more plenum chamber inlet ports, a seal-forming structure, and a positioning and stabilization structure. The seal-forming structure includes a nasal portion configured to seal around the lower side of the patient's nose during use. The nasal portion has a central portion configured to be disposed below the patient's nasal tip point during use and an intermediate portion configured to contact the corresponding nasal ala of the patient during use, and the intermediate portion is more rigid than the central portion.

[0099] One aspect of the present technology relates to a plenum chamber for a patient interface, the plenum chamber having at least 6 cmH above ambient air pressure throughout the patient's respiratory cycle during use 2It is possible to pressurize up to the therapeutic pressure of O. The plenum chamber includes one or more walls that at least partially enclose a space of a constant volume, and one or more plenum chamber inlet ports sized and structured to receive an air flow at the therapeutic pressure for the patient's breathing throughout the patient's respiratory cycle. It is a seal-forming structure constructed and arranged to form a seal against the area of the patient's face surrounding the inlet to the patient's airway. The seal-forming structure includes a nasal portion having at least one nasal hole configured to deliver the air flow at the therapeutic pressure to the inlet to the patient's nostrils during use. The seal-forming structure includes an oral portion having an oral hole configured to deliver the air flow at the therapeutic pressure to the inlet to the patient's mouth during use. The seal-forming structure includes a seal-forming structure constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle. The plenum chamber includes a positioning and stabilization structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure includes a nasal portion configured to seal around the lower side of the patient's nose during use. The nasal portion has a central portion configured to be disposed below the tip of the patient's nose during use and an intermediate portion configured to contact the corresponding alar of the patient during use. The intermediate portion is more rigid than the central portion.

[0100] In examples of the above two aspects, (a) the intermediate portion of the seal-forming structure may be thicker than the central portion, (b) the central portion of the seal-forming structure may include a forward-facing central portion and an upward-facing central portion, (c) each of the intermediate portions may include an upward-facing intermediate portion and a forward-facing intermediate portion, and the forward-facing central portion may be thinner than the forward-facing intermediate portion, (d) the side portions of the nasal portion may be configured to be pulled inward toward the alar of the patient when a downward force is applied from the patient's nose to the central portion, and / or (e) the seal-forming structure may be configured not to engage with the patient's face below the chin during use.

[0101] Aspects of the present technology relate to a patient interface including a plenum chamber including one or more walls, one or more plenum chamber inlet ports, a seal forming structure, and a positioning and stabilizing structure. The seal forming structure includes a nasal portion configured to seal around the lower side of the patient's nose. The nasal portion of the seal forming structure has a pair of nasal holes configured to deliver an air flow to the corresponding nostrils of the patient in use. The seal forming structure includes a bridge portion between the pair of nasal holes. The bridge portion is provided between a central portion of the nasal portion configured to be disposed below the tip point of the patient's nose in use and an upper lip portion of the nasal portion configured to seal the patient's upper lip in use. The bridge portion is flexible so as to be movable in a direction away from the upper lip portion with respect to the central portion in use.

[0102] Aspects of the present technology relate to a patient interface: The patient interface is a plenum chamber for a patient interface, and the plenum chamber has at least 6 cmH exceeding the ambient air pressure throughout the patient's breathing cycle in use. 2It is possible to pressurize up to the treatment pressure of O. The plenum chamber includes one or more walls that at least partially enclose a space of a constant volume, and one or more plenum chamber inlet ports sized and structured to receive an air flow at the treatment pressure for the patient's breathing throughout the patient's respiratory cycle. It is a seal-forming structure constructed and arranged to form a seal against the area of the patient's face surrounding the inlet to the patient's airway. The seal-forming structure includes a nasal portion having at least one nasal hole configured to deliver the air flow at the treatment pressure to the inlet to the patient's nostrils during use. The seal-forming structure includes an oral portion having an oral hole configured to deliver the air flow at the treatment pressure to the inlet to the patient's mouth during use. The seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use. The plenum chamber includes a seal-forming structure and a positioning and stabilization structure configured to generate a force for holding the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure includes a nasal portion configured to seal the periphery under the patient's nose. The nasal portion of the seal-forming structure has a pair of nasal holes configured to deliver an air flow to the corresponding nasal cavity of the patient during use. The seal-forming structure includes a bridge portion between the pair of nasal holes. The bridge portion is provided between a central portion of the nasal portion configured to be disposed under the tip of the patient's nose during use and an upper lip portion of the nasal portion configured to seal the patient's upper lip during use. The bridge portion is loose so that the central portion can move away from the upper lip portion during use.

[0103] In examples of the two above-described aspects, (a) the bridge portion includes a curved portion configured to be linear when the central portion moves in a direction away from the upper lip, (b) in use, the curved portion may be configured to extend in a direction away from the patient's nose in an undeformed state and to be linear when the central portion moves in a direction away from the upper lip, and / or (c) in use, the bridge portion allows the central portion to move forward with respect to the patient to receive the patient's nasal tip point and to be able to accommodate different nasal lengths when the patient wears the patient interface (without the upper lip being disengaged from the patient's upper lip).

[0104] Aspects of the technology relate to a plenum chamber for a patient interface that includes one or more plenum chamber inlet ports and a seal-forming structure. A first surface of a nasal portion configured to engage the patient's face has a first surface finish, and a second surface of an oral portion has a second surface finish different from the first surface finish.

[0105] One aspect of the technology relates to a plenum chamber for a patient interface, the plenum chamber having, in use, at least 6 cmH above ambient air pressure throughout the patient's respiratory cycle 2It is possible to pressurize up to the treatment pressure of O. The plenum chamber has one or more plenum chamber inlet ports sized and structured to receive an air flow at the treatment pressure for the patient's breathing, and a seal-forming structure constructed and arranged to form a seal against the area of the patient's face surrounding the inlet to the patient's airway. The seal-forming structure includes a nasal portion having at least one nasal aperture configured to deliver the air flow at the treatment pressure to the inlet to the patient's nostrils during use, the seal-forming structure includes an oral portion having an oral aperture configured to deliver the air flow at the treatment pressure to the inlet to the patient's mouth during use, and the seal-forming structure includes a seal-forming structure constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use. The first surface of the nasal portion configured to engage the patient's face has a first surface finish, and the second surface of the oral portion has a second surface finish different from the first surface finish.

[0106] In examples of the above two aspects, (a) the first surface finish and the second surface finish may differ such that the coefficient of friction between the seal-forming structure and the patient's face is higher at the oral portion than at the nasal portion, (b) the first surface finish may be configured to impart a smooth feel on the patient's face to the nasal portion, (c) the second surface finish may be configured to impart an improved grip feel on the patient's face to the oral portion, (d) the first surface finish may be a matte surface finish, (e) the second surface finish may be a polished surface finish, (f) the boundary between the first surface finish and the second surface finish may be disposed on a part of the seal-forming structure configured to contact the patient's cheeks during use, and / or (e) the seal-forming structure is configured not to engage the patient's face under the chin during use.

[0107] Aspects of the present technology relate to a patient interface: The patient interface includes a plenum chamber as described in any of the foregoing aspects or embodiments thereof, and a positioning and stabilization structure configured to generate a force for holding the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilization structure includes a tie, and the tie is constructed and arranged such that at least a portion thereof is disposed on a region of the patient's head above the superior auricular point of the patient's head during use. The patient interface further includes a ventilation structure configured to move a continuous gas flow exhaled by the patient from the interior of the plenum chamber to the atmosphere. The ventilation structure is sized and shaped such that it can maintain a therapeutic pressure within the plenum chamber during use. The patient interface is configured to allow the patient to breathe from the atmosphere through their own mouth when there is no pressurized air flow through one or more plenum chamber inlet ports.

[0108] According to one aspect of the present technology, a plenum chamber for a patient interface is provided. The plenum chamber has a pressure of at least 6 cmH above ambient air pressure. 2It is possible to pressurize up to the therapeutic pressure of O. The plenum chamber has an oral part and a nasal part. The plenum chamber is: a seal-forming structure constructed and arranged to form a seal against the area of the patient's face surrounding the entrance to the patient's airway. The seal-forming structure has one or more holes therein such that the airflow at the therapeutic pressure is delivered through the one or more holes to the entrance to the patient's nostrils and to the patient's mouth. The seal-forming structure is constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use. It includes a seal-forming structure, one or more plenum chamber inlet ports sized and structured to receive the airflow at the therapeutic pressure for the patient's breathing, and a shell that supports the seal-forming structure. The shell is provided at the oral part of the plenum chamber. Substantially the entire nasal part is formed by the seal-forming structure. The seal-forming structure includes a lateral support part located on at least a partially forward-facing side portion spaced laterally in the nasal part. The lateral support part has a higher resistance to deformation than one or more adjacent parts of the seal-forming structure.

[0109] According to another aspect of the present technology, a plenum chamber for a patient interface, wherein the plenum chamber is at least 6 cmH above ambient air pressure 2It is possible to pressurize up to the treatment pressure of O. The plenum chamber has an oral part and a nasal part. The plenum chamber includes a seal-forming structure constructed and arranged to form a seal against the area of the patient's face surrounding the entrance to the patient's airway. The seal-forming structure has one or more holes therein such that the airflow at the treatment pressure is delivered through the one or more holes to the entrance to the patient's nostrils and to the patient's mouth. The seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use. Substantially the entire nasal part is formed by the seal-forming structure. The seal-forming structure includes a lateral support part located on at least a partially forward-facing side spaced laterally of the nasal part. The lateral support part has a higher resistance to deformation than one or more adjacent parts of the seal-forming structure. A plenum chamber is provided.

[0110] In an example, the lateral support part is a part of the seal-forming structure that is relatively more rigid than one or more adjacent parts of the seal-forming structure. The lateral support part is a part of the seal-forming structure supported by a support structure. The support structure is part of a frame or a clip-type support part. The lateral support part includes a part of the seal-forming structure that is relatively thicker than one or more adjacent parts of the seal-forming structure. The lateral support part is provided substantially directly above the part of the shell. Each lateral support part has a substantially flat lower boundary provided adjacent to the upper edge of the shell. Each lateral support part has a curved upper boundary. The curvature of the upper boundary substantially matches or follows the curvature of the upper periphery of the seal-forming structure. The lateral support part is substantially in a fin-like shape.

[0111] In an example, the seal-forming structure includes a central portion configured to form a seal against the lower peripheral portion of the patient's nose and the patient's upper lip around the patient's nostrils during use. The central portion is thinner than the lateral support portions. The seal-forming structure includes an intermediate portion provided between the central portion and the lateral support portions. The seal-forming structure is thicker in the intermediate portion than in the central portion. The seal-forming structure is thinner in the intermediate portion than in the lateral support portions. The seal-forming structure includes a rearward-facing portion provided between each intermediate portion and the lateral support portions on each side of the nose portion. The thickness of the seal-forming structure is thicker at a rearward-facing portion further rearward than the intermediate portion. At least a part of each intermediate portion is provided above and in front of each lateral support portion. At least a part of each rearward-facing portion is provided above and behind each lateral support portion.

[0112] In an example, on each lateral side of the nose portion, the seal-forming structure includes a junction between each lateral support portion, the intermediate portion, and the rearward-facing portion. The junction is disposed close to the uppermost point of the lateral support portion. The junction is disposed in front of the uppermost point of the lateral support portion.

[0113] In an example, the central portion of the seal-forming structure includes a forward-facing central portion and an upward-facing central portion. The upward-facing central portion and the forward-facing central portion are interconnected by a central saddle region of the nose portion of the seal-forming structure. The upward-facing central portion has a positive curvature in the lateral direction. The sides of the upward-facing central portion partially face in the intermediate direction.

[0114] In an example, each intermediate portion includes an upward-facing central portion and a forward-facing central portion. The upward-facing central portion and the forward-facing central portion are interconnected across the upper peripheral portion of the seal-forming structure. The nose portion includes an upper lip portion configured to seal the patient's upper lip during use. The upper lip portion has a rigidity similar to that of the central portion. The upper lip portion has a wall thickness substantially equal to the thickness of the central portion. The upper lip portion includes a wall thickness smaller than the wall thickness of the intermediate portion.

[0115] In an example, the nasal portion includes a rear corner configured to be disposed on the patient's face proximate to the nasolabial fold on the patient's face, the rear corner being configured to contact the patient's face on each lateral portion on the upper lip, the rear corner being configured to contact the lateral and lower regions of the patient's face proximate to the ala, and the rear corner being configured to be adapted between the patient's ala and the nasolabial line of the patient.

[0116] In an example, the rear corner is more rigid than the nasal portion at the center of the seal-forming structure, the wall thickness of the rear corner is greater than the middle portion of the nasal portion, the wall thickness of the rear corner is less than the wall thickness of the rear portion facing the lateral direction of the nasal portion, the rear corner is substantially in a dome shape, and the transition between the rear corner and the upper lip portion is configured to be disposed under the ala of the patient during use.

[0117] In an example, the shell includes a rear protrusion that strengthens the seal-forming structure at the base of the nasal portion, the rear protrusion is provided at the upper lateral corner of the shell, the rearward-directed portion is provided under the lateral support portion, the rearward-directed portion has a flat upper edge, and the flat lower boundary of each lateral support portion is provided adjacent to each rearward-directed portion.

[0118] In an example, the oral portion includes a lower lip portion configured to form a seal against the patient's lower lip, the wall thickness of the lower lip portion is substantially equal to the wall thickness of the upper lip portion, the oral portion includes a periphery portion around the oral aperture, the wall thickness of the periphery portion around the oral aperture is substantially equal to the wall thickness of the upper lip portion, the periphery portion around the oral aperture is adjacent to one or both of the upper lip portion and the lower lip portion, the oral portion includes a laterally-directed rearward portion provided to either lateral side of the periphery portion around the oral aperture configured to seal the patient's cheeks during use, the wall thickness of the laterally-directed rearward portion is greater than the wall thickness of the periphery portion around the oral aperture, the laterally-directed rearward portion is curved in a direction away from contact with the patient's face, the lower lip portion is approximately half the width of the oral opening, the transition between the lower lip portion and the laterally-directed rearward portion on either lateral side of the lower lip portion is configured to be disposed at or near the mental fold of the patient's face, and the lower lip portion is wider at the periphery of the oral cavity than at the lower peripheral portion of the seal-forming structure.

[0119] In an example, the mouth portion includes a lateral portion at a lateral peripheral portion of the seal-forming structure, the wall thickness of the lateral portion is greater than the wall thickness of the rearward-facing lateral portion, the mouth portion includes a forward-facing lateral portion on the front side portion of the seal-forming structure, the wall thickness of the forward-facing lateral portion is greater than the wall thickness of the lateral portion, the mouth portion includes a forward support portion on the front side portion of the seal-forming structure, the wall thickness of the forward support portion is greater than the wall thickness of the forward-facing lateral portion, the mouth portion includes two forward support portions adjacent to the upper lateral corner of the shell, and the mouth portion includes two forward support portions adjacent to the lower lateral corner of the shell.

[0120] In an example, the plenum chamber includes a single plenum chamber inlet port, the single plenum chamber inlet port is provided centrally in the shell, the plenum chamber inlet port is configured to connect to the frame, and the plenum chamber inlet port is substantially circular.

[0121] According to another aspect of the present technology, a plenum chamber for a patient interface is provided, the plenum chamber is pressurizable to a therapeutic pressure of at least 6 cmH 2 O above ambient air pressure, the plenum chamber has a mouth portion and a nose portion, and the plenum chamber comprises: a seal-forming structure constructed and arranged to form a seal against a region of the patient's face surrounding an inlet to the patient's airway, the seal-forming structure having one or more holes therein such that airflow at the therapeutic pressure is delivered through the holes to an inlet to the patient's nostrils and to the patient's mouth, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use; and a shell configured to support the seal-forming structure, the shell having one or more plenum chamber inlet ports sized and structured to receive airflow at the therapeutic pressure for the patient's breathing, the shell including a lateral support portion that projects upwardly towards the nose portion of the patient interface and is located on at least a partially forward-facing side portion spaced laterally from the nose portion.

[0122] In an example, each of the lateral support portions has a curved upper boundary, and the curvature of the upper boundary substantially matches or follows the curvature of the upper peripheral portion of the seal formation structure, and the lateral support portions are substantially fin-shaped.

[0123] In an example, the plenum chamber includes two plenum chamber inlet ports, the plenum chamber inlet ports are provided on the lateral sides of the shell, the plenum chamber inlet ports are configured to connect to conduits, the plenum chamber inlet ports are approximately elliptical, and the upper peripheral portions of each of the two plenum chamber inlet ports are formed by one of the lateral support portions respectively.

[0124] According to another aspect of the present technology, a plenum chamber for a patient interface is provided, the plenum chamber being pressurizable to a treatment pressure of at least 6 cmH 2 O above ambient air pressure, the plenum chamber comprising: one or more walls at least partially enclosing a space of a constant volume; a seal formation structure constructed and arranged to form a seal against a region of the patient's face surrounding an inlet to the patient's airway, the seal formation structure having one or more holes therein such that an air flow at the treatment pressure is delivered through the one or more holes to an inlet to the patient's nostrils and to the patient's mouth; the seal formation structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use; and one or more plenum chamber inlet ports sized and structured to receive an air flow at the treatment pressure for respiration by the patient, the seal formation structure including a central portion configured to form a seal against the patient's upper lip and the lower peripheral portion of the patient's nose during use, and an intermediate portion configured to contact or be adjacent to the alae nasi of the patient's nose during use, the intermediate portion being more rigid than the central portion.

[0125] In an example, one or more walls may include some or all of the seal-forming structure, one or more walls may be separate from the seal-forming structure, the intermediate portion includes a pair of outer walls of the seal-forming structure that are partially oriented in the intermediate direction and partially upward, the intermediate portion is configured to withstand wrinkles, and the intermediate portion may be configured to limit the formation of leakage paths from the lower peripheral portion of the patient's nose to the surroundings due to wrinkles.

[0126] According to another aspect of the present technology, a plenum chamber for a patient interface is provided, the plenum chamber being pressurizable to a therapeutic pressure of at least 6 cmH 2 O above ambient air pressure, the plenum chamber comprising: one or more walls that at least partially enclose a space of constant volume; a seal-forming structure constructed and arranged to form a seal against a region of the patient's face surrounding an inlet to the patient's airway, the seal-forming structure having at least one hole therein such that air flow at the therapeutic pressure is delivered through the at least one hole to an inlet to the patient's nostrils and to the patient's mouth, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use; one or more plenum chamber inlet ports sized and structured to receive air flow at the therapeutic pressure for respiration by the patient, the seal-forming structure including a perioral aperture perimeter that surrounds at least a majority of a perioral aperture configured to surround the patient's mouth during use and a lateral perimeter support site provided at an opposing lateral side of the perioral aperture, the lateral perimeter support site being more rigid than the perioral aperture perimeter.

[0127] In an example, the wall thickness of the lateral peripheral support portion is greater than the wall thickness of the peripheral portion of the oral aperture, and the seal formation structure includes a rearward-facing lateral portion that surrounds most of the peripheral portion of the oral aperture. The rearward-facing lateral portion is thicker than the peripheral portion of the oral aperture, and the rearward-facing lateral portion forms the lateral peripheral support portion. The rearward-facing lateral portion extends in an intermediate direction toward the outermost edge of the oral cavity to form the lateral peripheral support portion, and the lateral support portion provides resistance to buckling of the seal formation structure.

[0128] According to another aspect of the present technology, a plenum chamber for a patient interface is provided. The plenum chamber is pressurizable to a treatment pressure of at least 6 cmH 2 O above ambient air pressure. The plenum chamber includes: one or more walls that at least partially enclose a space of a constant volume; one or more plenum chamber inlet ports sized and configured to receive an air flow at a treatment pressure for breathing by a patient; and a seal formation structure constructed and arranged to form a seal against a region of the patient's face surrounding an inlet to the patient's airway. The seal formation structure has one or more holes therein such that an air flow at the treatment pressure is delivered through the one or more holes to an inlet to the patient's nostrils and to the patient's mouth. The seal formation structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout a patient's respiratory cycle during use. The seal formation structure includes a nasal portion configured to form a seal against a lower peripheral portion of the patient's nose during use. The nasal portion has a central portion configured to be disposed below a tip point of the patient's nose during use and an intermediate portion configured to be disposed adjacent to a nasal wing of the patient during use. The seal formation structure has a higher rigidity in the intermediate portion than in the central portion.

[0129] In an example, the wall thickness of the middle part of the seal-forming structure is greater than the wall thickness of the central part. Each middle part may include a wall facing in the middle direction configured to be disposed adjacent to or near the patient's nasal wing during use. The central part of the seal-forming structure includes a front-facing central part and an upward-facing central part. The upward-facing central part and the front-facing central part are interconnected by the central saddle region of the nasal part of the seal-forming structure. The upward-facing central part includes a positive curvature in the lateral direction. The side parts of the upward-facing central part face partially in the middle direction. Each middle part includes the upward-facing central part and the front-facing central part. The upward-facing central part and the front-facing central part are interconnected throughout the upper peripheral part of the seal-forming structure. The wall thickness of the central saddle part is equal to the wall thickness of the central part. The wall thickness of the front-facing central part is smaller than the wall thickness of the front-facing middle part. When a downward force is applied from the patient's nose to the central part, the side parts of the nasal part are pulled inward toward the patient's nasal wing, and the middle parts are pulled inward toward the patient's nasal wing or its vicinity. The nasal part includes an upper lip part configured to seal the patient's upper lip during use. The upper lip part includes a rigidity similar to that of the central part. The wall thickness of the upper lip part is substantially equal to the wall thickness of the central part. The upper lip part includes a wall thickness smaller than the wall thickness of the middle part.

[0130] According to another aspect of the present technology, a plenum chamber for a patient interface is provided, and the plenum chamber has at least 6 cmH exceeding the ambient air pressure. 2It is possible to pressurize up to the treatment pressure of O, and the plenum chamber includes: one or more walls that at least partially enclose a space of a certain volume, and one or more plenum chamber inlet ports sized and structured to receive an air flow at the treatment pressure for breathing by the patient, and a seal-forming structure constructed and arranged to form a seal against the region of the patient's face surrounding the inlet to the patient's airway, the seal-forming structure having a plurality of holes therein such that the air flow at the treatment pressure is delivered through the plurality of holes to the inlet to the patient's nostrils and to the patient's mouth, and the seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, and the plenum chamber includes a nasal portion, and the seal-forming structure at the nasal portion is configured to seal the peripheral portion under the patient's nose, and the seal-forming structure defines a pair of nasal holes configured to deliver an air flow to the patient's nasal airway during use, and the seal-forming structure includes a bridge portion between the pair of nasal holes, and the bridge portion is provided at the center between the upper lip portion and the central portion of the seal-forming structure at the nasal portion, and the bridge portion is loose so that the central portion can move in a direction away from the rear region.

[0131] In an example, the bridge portion includes a curved portion configured to be linear when the central portion moves in a direction away from the upper lip portion, the curved portion includes a single curve, the curved portion includes two curves, the curved portion is approximately S-shaped when viewed laterally, the curved portion includes a serrated shape, the curved portion includes one or more folds, the bridge portion is suspended below the central portion and can be made linear when the central portion moves in a direction away from the upper lip portion, and due to the bridge portion, it is possible for the central portion to move to receive the patient's nose when the patient wears the patient interface, and due to the bridge portion, it is possible for the central portion to move forward to receive the patient's nasal tip point when the patient wears the patient interface.

[0132] According to another aspect of the present technology, a plenum chamber for a patient interface is provided, the plenum chamber being pressurizable to a treatment pressure of at least 6 cmH 2 O above ambient air pressure, the plenum chamber comprising: one or more plenum chamber inlet ports sized and configured to receive an air flow at a treatment pressure for breathing by a patient; and a seal-forming structure constructed and arranged to form a seal against a region of the patient's face surrounding an inlet to the patient's airway, the seal-forming structure having one or more holes therein such that the air flow at the treatment pressure is delivered through the one or more holes to an inlet to the patient's nostrils and to the patient's mouth, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, the seal-forming structure including a nasal portion configured to form a seal against the patient's nose or a region of the patient's face adjacent thereto, and an oral portion configured to form a seal against the patient's face around the patient's mouth, the seal-forming structure including a first surface finish within the nasal portion and a second surface finish different from the first surface finish within the oral portion.

[0133] In an example, the first surface finish and the second surface finish are different such that the coefficient of friction between the seal-forming structure and the patient's face is higher in the oral portion than in the nasal portion, the first surface finish being configured to impart a smooth feel on the patient's face to the nasal portion (e.g., for comfort), the second surface finish being configured to impart a gripping contact with the patient's face to the oral portion (e.g., for a more robust seal), the first surface finish may be a matte surface finish, the second surface finish may be a polished surface finish, the boundary between the first surface finish and the second surface finish is disposed on a portion of the seal-forming structure that contacts the patient's cheeks during use, the nasal portion may include an upper lip having the first surface finish, a surface of the nasal portion that does not contact the patient may include a surface finish other than the first surface finish, and a surface of the nasal portion that does not contact the patient may include the second surface finish.

[0134] According to another aspect of the present technology, a patient interface is provided: The patient interface includes a plenum chamber according to the aspect of the present technology described above, and a positioning and stabilization structure that provides a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilization structure including ties, the ties being constructed and arranged such that at least a portion thereof is disposed over a region of the patient's head above the upper ear base point of the patient's head during use, a positioning and stabilization structure, and a ventilation structure that moves a continuous gas flow exhaled by the patient from the inside of the plenum chamber to the atmosphere, the ventilation structure being sized and shaped such that it can maintain a therapeutic pressure within the plenum chamber during use, the patient interface being configured to allow the patient to breathe from the atmosphere through their own mouth when there is no pressurized air flow through the plenum chamber inlet port.

[0135] 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.

[0136] One aspect of one form of the present technology is a method of manufacturing the device.

[0137] One aspect of a particular form of the present technology is an easy-to-use medical device for, for example, people who have not received medical training, people who are not very dexterous or lack insight, or people with limited experience using this type of medical device.

[0138] One aspect of one form of the present technology is a portable RPT device that can be carried by a human (e.g., around their home).

[0139] One aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, for example, with soapy water, without the need for special cleaning equipment. One aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home, for example, with soapy water, without the need for special cleaning equipment.

[0140] The described methods, systems, devices, and apparatuses can be embodied to improve the functions in a processor (e.g., the functions of a processor of a special-purpose computer, a respiratory monitor, and / or a respiratory therapy device). Further, the described methods, systems, devices, and apparatuses enable improvements in the technical field of automatic management, monitoring, and / or treatment of respiratory conditions (e.g., sleep disordered breathing).

[0141] Of course, some of the above aspects can form sub-aspects of the present technology. Also, various combinations of one of the diverse sub-aspects and / or aspects can be made, which can also constitute further aspects or sub-aspects of the present technology.

[0142] Other features of the present technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

[0143] The present technology is illustrated by way of a non-limiting example in the accompanying drawings. In the drawings, like reference numerals include the following like elements. [Appended Claim 1] A patient interface comprising: A plenum chamber capable of pressurizing to a treatment pressure of at least 6 cmH 2 O exceeding the ambient air pressure throughout the patient's respiratory cycle during use, the plenum chamber having an oral site and a nasal site, the plenum chamber A seal-forming structure constructed and arranged to form a seal against a region of the patient's face surrounding an inlet to the patient's airway, the nasal site of the seal-forming structure having at least one nasal hole configured to deliver an air flow at the treatment pressure to an inlet to the patient's nostrils during use, the oral site of the seal-forming structure having an oral hole configured to deliver an air flow at the treatment pressure to an inlet to the patient's mouth during use, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's respiratory cycle during use, a seal-forming structure, and It has one or more plenum chamber inlet ports sized and structured to receive an airflow at a treatment pressure for breathing by a patient throughout the patient's respiratory cycle, and a shell that supports the seal-forming structure, a plenum chamber, a positioning and stabilization structure configured to generate a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, the shell is joined to the mouth portion of the plenum chamber, the seal-forming structure forms substantially the entire nasal region, the nasal region of the plenum chamber includes a rear corner configured to engage the patient's face in the vicinity of the nasolabial fold, at least a partially forward wall of the nasal region of the seal-forming structure includes two lateral support sites, the lateral support sites are each spaced laterally apart, and the lateral support sites are each of the seal-forming structure. A patient interface with higher resistance to deformation relative to the adjacent part. [Additional item 2] The lateral support sites are each thicker than the adjacent part of the seal-forming structure, the patient interface of additional item 1. [Additional item 3] The lateral support sites each have a curved upper boundary, the patient interface of additional item 1 or additional item 2. [Additional item 4] The lateral support sites are each substantially fin-shaped, the patient interface according to any one of additional items 1 to 3. [Additional item 5] The nasal region of the seal-forming structure includes a central portion configured to seal against the lower peripheral portion of the patient's nose around the patient's nostrils and the patient's upper lip, and the central portion is thinner than the lateral support sites. The patient interface according to any one of additional items 1 to 4. [Additional item 6] The nasal portion of the seal forming structure includes an intermediate portion provided between the central portion and the lateral support portion, and the intermediate portion is thicker than the central portion. The patient interface according to any one of appended claims 1 to 5. [Appended claim 7] The intermediate portion is thinner than the lateral support portion. The patient interface according to any one of appended claims 1 to 6. [Appended claim 8] The shell includes a rear protrusion configured to reinforce the seal forming structure at the base of the nasal portion during use. The patient interface according to any one of appended claims 1 to 7. [Appended claim 9] The seal forming structure is configured not to engage with the face of the patient with the jaw closed during use. The patient interface according to any one of appended claims 1 to 8. [Appended claim 10] A patient interface comprising: A plenum chamber capable of being pressurized to a therapeutic pressure of at least 6 cmH 2 O exceeding the ambient air pressure throughout the patient's respiratory cycle during use, the plenum chamber having an oral portion and a nasal portion, and the plenum chamber A seal forming structure constructed and arranged to form a seal against a region of the patient's face surrounding the patient's airway inlet, the nasal portion of the seal forming structure having at least one nasal hole configured to deliver the air flow at the therapeutic pressure to the inlet of the patient's nostrils during use, the oral portion of the seal forming structure having an oral hole configured to deliver the air flow at the therapeutic pressure to the inlet of the patient's mouth during use, and the seal forming structure being constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use. A seal forming structure, and A shell configured to support the seal-forming structure and having one or more plenum chamber inlet ports sized and structured to receive an airflow at a therapeutic pressure for breathing by a patient throughout the patient's respiratory cycle, the shell, including a plenum chamber. A positioning and stabilization structure configured to generate a force for holding the seal-forming structure in a therapeutically effective position on the patient's head, including. The shell includes two lateral support portions that project upward into at least a portion of the front wall of the nasal portion of the seal-forming structure, and the lateral support portions are each spaced laterally apart. The patient interface according to any one of claims 1 to 7. [Claim 11] Each of the lateral support portions has a curved upper boundary. The patient interface of claim 10. [Claim 12] The curvature of the curved upper boundary substantially matches or substantially follows the curvature of the upper peripheral portion of the seal-forming structure. The patient interface of claim 10 or 11. [Claim 13] The shell includes two plenum chamber inlet ports. The patient interface according to any one of claims 10 to 12. [Claim 14] The upper boundary of each of the two plenum chamber inlet ports is formed by one of the lateral support portions respectively. The patient interface according to any one of claims 10 to 13. [Claim 15] A patient interface comprising: A plenum chamber for a patient interface, the plenum chamber being pressurizable to a therapeutic pressure of at least 6 cmH 2 O exceeding the ambient air pressure throughout the patient's respiratory cycle, and the plenum chamber One or more walls that at least partially enclose a space of a constant volume, A seal-forming structure constructed and arranged to form a seal against a region of the patient's face surrounding the patient's airway inlet, the seal-forming structure including a nasal portion having at least one nasal aperture configured to deliver an airflow at the treatment pressure to an inlet to the patient's nostrils during use, the seal-forming structure including an oral portion having an oral aperture configured to deliver an airflow at the treatment pressure to an inlet to the patient's mouth during use, the seal-forming structure being constructed and arranged to maintain the treatment pressure within a plenum chamber throughout the patient's respiratory cycle during use, the seal-forming structure and, A plenum chamber including one or more plenum chamber inlet ports sized and structured to receive an airflow at the treatment pressure for the patient's respiration throughout the patient's respiratory cycle during use. A positioning and stabilization structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure includes a central portion configured to seal around the lower periphery of the patient's nose during use. The seal-forming structure includes an intermediate portion configured to contact the patient's nasal wings during use, the intermediate portion being more rigid than the central portion, the patient interface. [Claim 16] The intermediate portion of the patient interface of claim 15 includes a pair of outer walls of the seal-forming structure that are oriented partially in an intermediate direction and partially in an upward direction. [Claim 17] The intermediate portion of the patient interface of claim 15 or 16 is configured to withstand folds. [Claim 18] The intermediate portion of the patient interface according to any one of claims 15 to 17 is configured to limit a situation in which a leakage path is formed from the lower periphery of the patient's nose to the surroundings due to folds. [Claim 19] The intermediate portion of the patient interface according to any one of claims 15 to 18 is thicker than the central portion. [Additional item 20] The seal formation structure is configured not to engage with the face of the patient with jaws during use, and is the patient interface according to any one of additional items 15 to 19. [Additional item 21] A patient interface comprising: A plenum chamber for a patient interface, the plenum chamber being pressurizable to at least 6 cmH 2 O of therapeutic pressure exceeding the ambient air pressure throughout the patient's breathing cycle during use, and the plenum chamber One or more walls that at least partially enclose a constant volume space, A seal formation structure constructed and arranged to form a seal against a region of the patient's face surrounding an entrance to the patient's airway, the seal formation structure including a nasal portion having at least one nasal hole configured to deliver an air flow at the therapeutic pressure to an entrance to the patient's nostrils during use, the seal formation structure including an oral portion having an oral hole configured to deliver an air flow at the therapeutic pressure to an entrance to the patient's mouth during use, the seal formation structure being constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's breathing cycle during use, the seal formation structure; One or more plenum chamber inlet ports sized and structured to receive an air flow at a therapeutic pressure for breathing by the patient throughout the patient's breathing cycle during use, and a plenum chamber; A positioning and stabilization structure configured to generate a force for holding the seal formation structure in a therapeutically effective position on the patient's head. The seal formation structure includes a peripheral portion of the oral hole that surrounds at least a majority of the oral hole configured to surround the patient's mouth during use. The seal-forming structure includes a laterally peripheral support portion provided at a laterally opposing portion of the oral cavity hole, the laterally peripheral support portion is adjacent to the peripheral portion of the oral cavity hole, and the laterally peripheral support portion is higher in rigidity than the peripheral portion of the oral cavity hole, patient interface. [Appended Claim 22] The laterally peripheral support portion of the patient interface according to appended claim 21 is thicker than the peripheral portion of the oral cavity hole. [Appended Claim 23] The seal-forming structure includes a rearward-facing lateral portion that surrounds most of the peripheral portion of the oral cavity hole, and the rearward-facing lateral portion is thicker than the peripheral portion of the oral cavity hole, the patient interface according to appended claim 21 or 22. [Appended Claim 24] The rearward-facing lateral portion extends in an intermediate direction toward the outermost lateral edge of the oral cavity to form the laterally peripheral support portion, the patient interface according to any one of appended claims 21 to 23. [Appended Claim 25] The seal-forming structure is configured not to engage with the face of a patient with the jaw closed during use, the patient interface according to any one of appended claims 21 to 24. [Appended Claim 26] A patient interface comprising: A plenum chamber for a patient interface, the plenum chamber being pressurizable to a treatment pressure of at least 6 cmH 2 O that exceeds the ambient air pressure throughout the patient's respiratory cycle during use, and the plenum chamber One or more walls that at least partially enclose a space of a constant volume, and One or more plenum chamber inlet ports sized and structured to receive an air flow at a treatment pressure for the patient's respiration throughout the patient's respiratory cycle during use, and A seal-forming structure constructed and arranged to form a seal against a region of the patient's face surrounding the entrance to the patient's airway, the seal-forming structure including a nasal portion having at least one nasal aperture configured to deliver airflow at the treatment pressure to an entrance to the patient's nostrils during use, the seal-forming structure including an oral portion having an oral aperture configured to deliver airflow at the treatment pressure to an entrance to the patient's mouth during use, the seal-forming structure including a seal-forming structure constructed and arranged to maintain the treatment pressure within a plenum chamber throughout the patient's respiratory cycle during use, and a plenum chamber. A positioning and stabilization structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure includes a nasal portion configured to seal around the lower periphery of the patient's nose during use, the nasal portion having a central portion configured to be disposed below the tip of the patient's nose during use and an intermediate portion configured to contact the corresponding nasal ala of the patient during use, the intermediate portion being more rigid than the central portion, a patient interface. [Claim 27] The intermediate portion of the seal-forming structure is thicker than the central portion, the patient interface of claim 26. [Claim 28] The central portion of the seal-forming structure includes a front-facing central portion and an upward-facing central portion. Each of the intermediate portions includes an upward-facing intermediate portion and a front-facing intermediate portion. The front-facing central portion is thinner than the front-facing intermediate portion, the patient interface of claim 26 or 27. [Claim 29] The side portions of the nasal portion are configured to be pulled inwardly toward the patient's nasal ala when a downward force is applied from the patient's nose to the central portion, the patient interface according to any one of claims 26 to 28. [Claim 30] The seal-forming structure is configured not to engage with the face of the patient with jaws closed during use, the patient interface according to any one of appended claims 26 to 29. [Appended claim 31] A patient interface comprising: A plenum chamber for a patient interface, the plenum chamber being pressurizable to at least 6 cmH 2 O of therapeutic pressure exceeding ambient air pressure throughout the patient's respiratory cycle during use, the plenum chamber One or more walls at least partially enclosing a space of constant volume, One or more plenum chamber inlet ports sized and configured to receive an air flow at a therapeutic pressure for respiration by the patient throughout the patient's respiratory cycle during use, A seal-forming structure constructed and arranged to form a seal against a region of the patient's face surrounding an inlet to the patient's airway, the seal-forming structure including a nasal portion having at least one nasal aperture configured to deliver an air flow at the therapeutic pressure to an inlet to the patient's nostrils during use, the seal-forming structure including an oral portion having an oral aperture configured to deliver an air flow at the therapeutic pressure to an inlet to the patient's mouth during use, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use, the seal-forming structure, and a plenum chamber; A positioning and stabilization structure configured to generate a force for holding the seal-forming structure in a therapeutically effective position on the patient's head. The seal-forming structure includes a nasal portion configured to seal the area around the lower side of the patient's nose. The nasal portion of the seal-forming structure has a pair of nasal holes configured to deliver an air flow to the corresponding nostrils of the patient during use. The seal-forming structure includes a bridge portion between the pair of nasal holes. The bridge portion is provided between a central portion of the nasal portion configured to be disposed below the tip point of the patient's nose during use and an upper lip portion of the nasal portion configured to seal the patient's upper lip during use. The bridge portion is loose so that the central portion can move in a direction away from the upper lip portion during use, patient interface. [Appendix 32] The patient interface according to Appendix 31, wherein the bridge portion includes a curved portion configured to be linear when the central portion moves in a direction away from the upper lip portion. [Appendix 33] The patient interface according to Appendix 31 or 32, wherein the curved portion is configured to extend in a direction away from the patient's nose in an undeformed state during use and to be linear when the central portion moves in a direction away from the upper lip portion. [Appendix 34] During use, the bridge portion allows the central portion to move forward with respect to the patient to receive the tip point of the patient's nose, so that when the patient wears the patient interface, it is possible to correspond to different nose lengths without the upper lip portion being disengaged from the patient's upper lip. The patient interface according to any one of Appendices 31 to 33. [Appendix 35] A patient interface comprising: A plenum chamber for a patient interface, the plenum chamber being pressurizable to at least 6 cmH 2 O of therapeutic pressure exceeding the ambient air pressure throughout the patient's respiratory cycle, and the plenum chamber One or more plenum chamber inlet ports sized and structured to receive an air flow at a therapeutic pressure for the patient's breathing, and A seal-forming structure constructed and arranged to form a seal against a region of the patient's face surrounding the entrance to the patient's airway, the seal-forming structure including a nasal portion having at least one nasal aperture configured to deliver an airflow at the treatment pressure to an entrance to the patient's nostrils during use, the seal-forming structure including an oral portion having an oral aperture configured to deliver an airflow at the treatment pressure to an entrance to the patient's mouth during use, the seal-forming structure being constructed and arranged to maintain the treatment pressure within a plenum chamber throughout the patient's respiratory cycle during use, a plenum chamber, and a seal-forming structure, a positioning and stabilization structure configured to generate a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, A patient interface, wherein a first surface of the nasal portion configured to engage the patient's face has a first surface finish, and a second surface of the oral portion has a second surface finish different from the first surface finish. [Appendix 36] The patient interface according to Appendix 35, wherein the first surface finish and the second surface finish are different such that a coefficient of friction between the seal-forming structure and the patient's face is higher at the oral portion than at the nasal portion. [Appendix 37] The patient interface according to Appendix 35 or 36, wherein the first surface finish is configured to impart a smooth feel on the patient's face to the nasal portion. [Appendix 38] The patient interface according to any one of Appendices 35 to 37, wherein the second surface finish is configured to impart an improved grip feel on the patient's face to the oral portion. [Appendix 39] The patient interface according to any one of Appendices 35 to 38, wherein the first surface finish is a matte surface finish. [Appendix 40] The patient interface according to any one of Appendices 35 to 39, wherein the second surface finish is a polished surface finish. [Additional item 41] The boundary between the first surface finish and the second surface finish is disposed in a part of the seal forming structure configured to contact both cheeks of the patient during use, and the patient interface according to any one of claims 35 to 40. [Additional item 42] The seal forming structure is configured not to engage with the face of the patient with the jaw closed, and the patient interface according to any one of claims 35 to 41.

Brief Description of the Drawings

[0144]

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[0145] 5 DETAILED DESCRIPTION OF THE EXAMPLES OF THE PRESENT TECHNOLOGY

[0146] Before further elaborating on the present technology, 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.

[0147] 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.

[0148] Terms indicating anatomical directions are used in the description of aspects and examples of the present technology (e.g., "front", "rear", "upper", "lower", "lateral", "medial"), and these directions are applied in the context of the present technology during use by a patient. For example, the front portion of a patient interface refers to the side of the patient interface that is in front of the patient when the patient wears the patient interface in the intended manner.

[0149] When describing the orientation of a surface or site in any direction (e.g., "facing upward", "facing forward"), unless it is clear from the context, the surface or site is understood to be at least partially oriented in a particular direction. If a site generally faces upward, the site can be said to "face upward" even if it is partially oriented in another direction.

[0150] 5.1 Treatment

[0151] In one form, the present technology includes a method of treating a respiratory disease. The method includes the step of applying positive pressure to the inlet of the airway of patient 1000.

[0152] In certain embodiments of the present technology, air supply at positive pressure is provided to the patient's nasal passages via one or both of the nostrils.

[0153] In certain embodiments of the present technology, mouth breathing is restricted, limited, or prevented.

[0154] 5.2 Treatment System

[0155] In one form, the present technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device may include an RPT device 4000 that supplies pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000.

[0156] 5.3 Patient Interface

[0157] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional modalities: a plenum chamber 3200 including a seal-forming structure 3100, a positioning and stabilization structure 3300, a ventilation portion 3400, one form of a 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.

[0158] In some examples of the present technology, the plenum chamber 3200 is at least partially formed by a shell 3210 and a seal-forming structure 3100. The plenum chamber 3200 may include, for example, a cushion module or a cushion assembly. The shell 3210 may function as a chassis for the seal-forming structure 3100.

[0159] In some examples of the present technology, the patient interface 3000 is an oro-nasal patient interface. That is, the patient interface 3000 is configured to seal both the patient's nasal airway and oral airway. In some examples, the patient interface 3000 includes separate seals around each of the nasal airway and oral airway. For example, as shown in FIGS. 7-14, FIGS. 49-56, FIGS. 119-125, and FIGS. 126-157, the patient interface 3000 may include a plenum chamber 3200 having a nasal portion 3230 and an oral portion 3260. The seal-forming structure may be configured to surround the nasal airway at the nasal portion 3230 and seal around the patient's mouth at the oral portion 3260. Thus, the seal-forming structure 3100 may be regarded as having a nasal portion and an oral portion, and the nasal portion and oral portion of the seal-forming structure include portions that seal around the patient's nasal airway and oral cavity, respectively.

[0160] In the examples shown in FIGS. 7-14, FIGS. 49-56, FIGS. 119-125, and FIGS. 126-157, the seal-forming structure 3100 at the nasal portion 3230 seals the lower surface of the patient's nose rather than being disposed on the bridge or nasal sill region of the patient's face. The nasal portion 3230 may seal the upper lip, alae nasi, and the front and / or lower surface of the nasal tip point. The actual sealing position may vary depending on the patient. The nasal portion 3230 may also be configured to make contact and / or seal with the region of the patient's face between the alae nasi and nasolabial groove and the lateral portion of the upper lip adjacent to the nasolabial groove.

[0161]

[0162] The seal-forming structure 3100 at the oral portion 3260 may be configured to form a seal against the periphery of the patient's mouth during use. The oral portion 3260 may be configured to form a seal against the patient's face, for example, at the upper lip, nasolabial groove, cheek, lower lip, and chin.One or more holes may be provided inside the seal forming structure 3100, and through these holes, the air flow of the treatment pressure is delivered to the patient's nostrils and the patient's mouth through one or more holes. The seal forming structure may define a mouth hole and one or more nose holes for delivering the air flow to the patient. In the examples shown in FIGS. 7-14, FIGS. 49-56, FIGS. 119-125, and FIGS. 126-157, the plenum chamber 3200 includes a seal forming structure 3100 that includes a mouth hole 3271 and two nose holes 3272. Each of the nose holes 3272 may be positioned on the plenum chamber 3200 to be substantially aligned with the patient's nostrils during use so as to deliver the air flow to the patient's nostrils.

[0163] If the patient interface cannot comfortably deliver the lowest level of positive pressure to the airway, the patient interface may be inappropriate for respiratory pressure therapy.

[0164] The patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH 2 O.

[0165] The patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH 2 O.

[0166] The patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH 2 O.

[0167] 5.3.1 Plenum Chamber

[0168] The plenum chamber 3200 has a perimeter of a shape that is complementary to the surface profile of an average person's face in the region where a seal is formed during use. In the examples shown in FIGS. 7-14, FIGS. 49-56, FIGS. 119-125 and FIGS. 126-157, the plenum chamber includes a shell 3210 and a seal-forming structure 3100. In these embodiments, the peripheral edge of the plenum chamber 3200 is positioned proximate to the adjacent surface of the face. The actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 can extend around the entire perimeter of the plenum chamber 3200 during use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material.

[0169] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside of the pressurized space defined by the plenum chamber. In such forms, treatment compliance can be improved because the pressure is often reduced and / or the comfort of the wearer is increased.

[0170] In certain forms of the present technology, a portion of the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). In the examples shown in FIGS. 7-14, FIGS. 49-56, FIGS. 119-125 and FIGS. 126-157, the shell 3210 is made of clear polycarbonate. The use of a transparent material can reduce the harshness of the pressure of the patient interface and can assist in improving compliance with treatment. The use of a transparent material can assist the clinician in verifying the placement and function of the patient interface. In some examples, the shell 3210 can be formed from silicone.

[0171] In certain forms of the present technology, the plenum chamber 3200 is composed of a translucent material. By using a translucent material, the harshness of the pressure of the patient interface can be reduced and compliance with treatment can be assisted.

[0172] Figures 7 to 47, Figures 49 to 75, and Figures 119 to 183 show a plenum chamber 3200 according to an example of the present technology, which is partially formed by a shell 3210. Further, the plenum chamber 3100 is partially formed by a seal-forming structure 3200. In some examples, the seal-forming structure 3100 is overmolded onto the shell 3210. Alternatively, the seal-forming structure 3100 may be formed separately from the shell 3210 and configured to be permanently or removably connected to the shell 3210. The seal-forming structure 3100 and the shell 3210 may be integrally formed.

[0173] In the examples shown in Figures 7 to 47, Figures 49 to 75, and Figures 119 to 183, the shell 3210 is formed from polycarbonate and the seal-forming structure 3100 is formed from silicone. The Shore A hardness of the silicone can be 30 or 40 durometers. In the case of this highly formulated silicone or similar materials, it is advantageous in terms of conforming to the patient's face and comfort and flexibility in the seal. Using polycarbonate (or other more rigid materials) with higher hardness and rigidity than silicone is advantageous in that a site with higher resistance to deformation is obtained (with less material than would be required to obtain the same resistance using silicone). Reducing the materials used can be advantageous in maintaining a reduction in overall bulk and weight, and the pressing on the user can be reduced. In another example, the shell 3210 can be formed from nylon or polypropylene. Alternatively, the seal-forming structure 3100 can be formed from silicone, a suitable foam, or any suitable thermoplastic elastomer.

[0174] As shown in FIGS. 40 to 46, the shell 3210 may have a rear protrusion 3215 at the upper lateral corner of the shell 3210. The rear protrusion 3215 may strengthen the base of the nasal portion and support the stabilization of the seal formation structure 3100. The rear protrusion 3215 also supports the strengthening of the position of the rear corner 3131 close to the seal formation structure (such as those shown in FIGS. 10 and 52), thereby supporting the nasal portion of the plenum chamber on the patient's face and also fitting advantageously into the patient's nasolabial groove. The rear protruding portion 3215 may protrude from the shell 3210 towards the position of the patient's nasolabial groove or both cheeks of the patient along the nasolabial groove. The rear protruding portion 3215 may be provided below the lateral support portion 3151 (described below).

[0175] 5.3.1.1 Lateral support portion

[0176] In some examples of the present technology, as shown in FIGS. 18, 19, 32, 35, and 38, the plenum chamber 3200 includes a lateral support portion 3151 on the front side of the nasal portion 3230 of the plenum chamber 3200. The lateral support portion 3151 may have a higher resistance to deformation than one or more adjacent portions 3100 of the seal formation structure. The lateral support portion 3151 may be more rigid than the region of the plenum chamber 3200 above the lateral support portion 3151. Additionally or alternatively, the lateral support portion 3151 may be more rigid than the central region of the plenum chamber 3200. The relatively higher-rigidity region may take the form of a fin shape configured to provide a relatively higher-rigidity region than the peripheral region of the plenum chamber. The seal formation structure 3100 shown in FIGS. 34 to 38 includes the lateral support portion 3151 therein. Further, the plenum chamber 3200 shown in FIGS. 49 to 56 includes the lateral support portion 3151 within the shell 3210. The state where the shell 3210 of the plenum chamber 3200 in FIGS. 49 to 56 is in an isolated state in FIGS. 81 to 86 is illustrated. As shown, the lateral support portion 3151 is formed by the upper lateral portion of the shell 3210 itself.

[0177] The lateral support portion 3151 can assist in the lateral stability of the nasal portion 3230 of the plenum chamber 3200. In the examples of FIGS. 7-38, the lateral support portion 3151 is provided to at least partially forward-facing side portions spaced laterally of the plenum chamber 3200. Specifically, the lateral support portion 3151 is provided to the side of the nasal portion 3230 that does not face the patient (e.g., the front side portion or at least partially forward-facing side portion). In these examples, one lateral support portion 3151 is provided to a wall that at least partially faces forward on each lateral side portion of the plenum chamber 3200. The plenum chamber 3200 is configured such that the lateral support portion 3151 is disposed within the seal-forming structure 3100 generally opposite the patient's nasal alae during use.

[0178] The lateral support portion 3151 can include a region of the plenum chamber 3200 having a greater material thickness than the surrounding or adjacent regions. Alternatively or additionally, the lateral support portion 3151 can be formed of a material having a higher rigidity than the material in the surrounding or adjacent regions.

[0179] The lateral support portion 3151 can be substantially fin-shaped (e.g., having a curved upper boundary and a flatter lower boundary). As shown in FIGS. 34-38, the lateral support portion 3151 of the seal forming structure 3100 includes a curved upper boundary 3153 and a flatter lower boundary 3152. Similarly, the lateral support portion 3151 of the shell 3210 as shown in FIGS. 49-56 has a curved upper boundary 3153 (however, in this example, there is no separate lower boundary of the lateral support portion 3151). Using a fin-shaped configuration (specifically, providing a curved upper boundary or edge) is advantageous because the upper edge or boundary of the lateral support portion 3151 follows the curvature of the upper peripheral portion 3232 of the nose portion 3230. This results in a consistent height of the nose portion 3230 above the shell 3210 and can be advantageous in that the rigidity of the structure of the nose portion 3230 is made consistent or controlled as described below. Further, the curved upper boundary 3153 rather than a flat boundary around the entire front portion of the nose portion 3230 allows the portion facing forward of the center of the nose portion to retain flexibility, thus avoiding excessive force on the patient's nasal tip point.

[0180] The collapsibility of the front portion of the plenum chamber 3200 can be controlled by the lateral support portion 3151. The height of the lateral support portion 3151 (e.g., the amount of the upper extension) can be selected such that a balance between collapsibility and structural rigidity is obtained. It is desirable to have a certain amount of flexibility in the structure of the seal forming structure 3100 because this allows the seal forming structure 3100 to accommodate a wide range of nasal shapes and sizes. However, if the lateral support portion 3151 extends upward too much, the accommodation or comfort of the seal forming structure 3100 may become insufficient. Alternatively, if the lateral support portion 3151 does not extend upward sufficiently, the seal forming structure 3100 may be prone to collapse, making it impossible to avoid rupture of the hermetic engagement with the patient's face.

[0181] Furthermore, providing a certain flexibility to the overall structure of the seal-forming structure 3100 can be advantageous in accommodating long and / or narrow noses. When the seal-forming structure 3100 is moved upward to contact the underside of a narrow nose, a certain amount of flexibility in the overall structure of the nose portion 3230 is undesirable. This is because, due to such flexibility, as a downward force from the patient's nose is added to the center of the seal-forming structure 3100, the lateral portions of the seal-forming structure 3100 can be pulled inward. FIGS. 112 and 113 show the seal-forming structure 1000 before and after being moved to a sealed position with the patient's nose. As shown in FIG. 113, when the seal-forming structure 3100 in the nose portion 3230 is brought into contact with the patient's nose, the lateral portions facing outward of the seal-forming structure 3100 are pulled inward, assisting the lateral portions facing inward of the seal-forming structure 3100 to conform to the peripheral portion under the patient's nose. If the flexibility of the lateral portions of the seal-forming structure 3100 is insufficient, when the patient needs to tighten the headgear for compensation, the adaptation of the seal-forming structure 3100 to the narrow nose and / or the comfort may decrease. If the flexibility becomes excessive, the seal-forming structure 3100 may not be able to maintain its shape and maintain an effective seal.

[0182] The height of the lateral support portion 3151 needs to be appropriate to provide sufficient structural rigidity to the nose portion 3230 while maintaining sufficient flexibility to enable the seal-forming structure 3100 to comfortably seal a wide range of noses. The lateral support portion 3151 can extend upward by approximately 35% to 65% of the height of the nose portion 3230 (for example, in an example, 40% to 60% or 50% of the distance between the base 3230 of the nose portion on the front side of the plenum chamber 3200 and the uppermost point of the plenum chamber 3200).

[0183] In other examples, instead of the lateral support portion 3151, other stiffening / hardening structures or features may be used. In some examples, for imparting structural rigidity to the nasal portion 3230, ribs are provided inside or outside the nasal portion 3230 of the seal forming structure 3100 generally at the location of the lateral support portion 3151. In other examples, the lateral support portion 3151 may be hardened. The seal forming structure 3100 may include a support insert (e.g., a hardening agent element) provided to the lateral support portion 3151. In one example, for imparting rigidity to the lateral support portion 3151, the seal forming structure 3100 may be overmolded onto one or more hardening agent elements.

[0184] In other examples, the plenum chamber 3200 may include an undercushion that provides the necessary support to the structure of the nasal portion 3230. Since the undercushion may be thicker than the face contact portion of the seal forming structure 3100, it is possible to thin the patient contact wall for comfort and conform it to the patient's nose and face.

[0185] Furthermore, in some examples, a separate component is provided for supporting the structure of the nasal portion 3230 of the seal forming structure 3100. For example, the frame to which the plenum chamber 3200 is connected may have a portion that strengthens the seal forming structure 3100 within the region of the lateral support portion 3151.

[0186] 5.3.1.1.1 Lateral Support Portion Formed by Seal Forming Structure

[0187] The plenum chamber 3200 shown in FIGS. 7 - 40 includes a lateral support portion 3151 provided by the seal forming structure 3100. The lateral support portion 3151 is provided to the front side of the plenum chamber 3200 and on each lateral side of the nasal portion 3230. In this example, the lateral support portion 3151 is provided in the lower region of each lateral side of the nasal portion 3230.

[0188] In this example, at least a majority of the nasal portion 3230 is formed by the seal-forming structure 3100. A majority of the nasal portion 3230 of the plenum chamber 3200 is formed from a soft, flexible elastomeric material. In this example, a majority of the nasal portion 3230 is formed from silicone. In the examples of FIGS. 7-33, substantially the entire nasal portion is formed by the seal-forming structure 3100. In the examples of FIGS. 49-75, the portion of the nasal portion is formed by the shell 3210.

[0189] In these examples, the lateral support portion 3151 is a region of the seal-forming structure 3100 and is of relatively higher stiffness than one or more adjacent regions of the seal-forming structure 3100. Specifically, the lateral support portion 3151 has a thicker material than the region of the seal-forming structure 3100 above the lateral support portion 3151. Such a thicker material thickness imparts a certain amount of stiffness or structural rigidity to the structure of the seal-forming structure 3100 and in particular to the nasal portion 3230. Since the majority of the posterior side of the nasal portion 3230 has a thin wall thickness for comfort and can seal against the patient's face, it does not lead to a significant structural rigidity of the shape of the nasal portion 3230. The lateral support portion 3151 compensates for the lack of structural rigidity obtained from the patient contact wall and increases the overall structural rigidity with respect to the nasal portion 3230.

[0190] As shown in FIGS. 35 and 38, each of the lateral support portions 3151 includes a substantially flat lower boundary 3152. Although the substantially flat lower boundary 3152 is generally flat, it may have a small amount of curvature due to, for example, a certain curvature necessary for the base of the nasal portion to transition into the mouth portion 3260 of the plenum chamber 3200. Each flat lower boundary 3152 may be adjacent to each posterior protrusion 3215 of the shell 3210. In this example, each of the lateral support portions 3151 includes a curved upper boundary 3153. Further, the curvature of the curved upper boundary 3153 may substantially match or follow the curvature of the upper peripheral portion 3232 of the seal-forming structure 3100 at the nasal portion 3230.

[0191] 5.3.1.1.2 Lateral support portion formed by the shell

[0192] The plenum chambers 3200 shown in FIGS. 49 to 75 and FIGS. 126 to 157 each include a lateral support portion 3151 provided by the shell 3210 of the plenum chamber 3200. FIGS. 81 to 86 show the shell 3210 of the plenum chamber 3200 in an isolated state among FIGS. 49 to 75. In these examples, the lateral support portion 3151 includes the upper portion of the shell 3210. The lateral support portion 3151 extends upward into the nose portion 3230 of the plenum chamber 3200. In these examples, the lateral support portion 3151 includes the portion of the shell 3210 provided to the nose portion 3230. In the examples shown in FIGS. 7 to 33, the shell 3210 generally has a flat upper edge, but the shell 3210 in the examples shown in FIGS. 49 to 75 and FIGS. 81 to 86 includes a curved upper edge 3211 including the lateral support portion 3151. The lateral support portion 3151 extends upward over a wider range than the central portion of the upper edge 3211 to form two lateral support portions 3151. In these examples, each lateral support portion 3151 includes a curved upper edge or boundary. The curvature of each upper edge substantially matches or follows the curvature of the upper peripheral portion 3232 of the seal formation structure. The lateral support portion 3151 of the shell 3210 occupies the regions of the side portion facing forward and the side portion facing laterally of the nose portion 3230 and is approximately in the opposite direction to the patient's nasal wings during use.

[0193] The lateral support portion 3151 in the examples shown in FIGS. 49 to 75 and FIGS. 81 to 86 provides the same function as the lateral support portion 3151 shown in the examples of FIGS. 7 to 33. The lateral support portion 3151 imparts structural rigidity to the nose portion 3230 of the seal formation structure 3100. Since the patient contact (rear) side of the seal formation structure 3100 includes a relatively thin and flexible wall, a certain level of structural rigidity is imparted to the nose portion 3230 by the flexible wall and the lateral support portion 3151.

[0194] 5.3.1.2 Plenum Chamber Inlet Port

[0195] The shell 3210 may include one or more plenum chamber inlet ports 3240. The one or more plenum chamber inlet ports 3240 may enable connection to other components (e.g., a frame, a decoupling structure, a ventilation arrangement, a heat and moisture exchanger (HMX), a constant flow vent (CFV), an anti-asphyxiation valve (AAV), and / or connection ports to conduits in various examples).

[0196] In the examples shown in FIGS. 7-14, the plenum chamber 3200 includes a single inlet port 3240. The inlet port 3240 is provided substantially centrally within the shell 3210. In this example, the inlet port 3240 may be configured to connect to a frame that can connect a headgear or other positioning and stabilization structure components. In this exemplary form of the technology, the inlet port 3240 is substantially circular.

[0197] In the examples shown in FIGS. 49-56 and FIGS. 126-183, the plenum chamber 3200 includes two inlet ports 3240. The inlet ports 3240 are provided to the lateral sides 3210 of the shell. In these examples, the inlet ports 3240 are configured to connect to conduits that connect to a decoupling component disposed above the head of a patient where the conduit is connected to an air circuit. These conduits may form part of a positioning and stabilization structure 3300 (i.e., may be "headgear conduits"). In some examples, for providing multiple functions (e.g., ventilation, supply of air flow, and headgear attachment points), the inlet ports 3240 may receive a combined headgear and conduit connection assembly. The combined headgear and conduit connection assembly may also include an AAV. In these examples, the inlet ports 3240 are approximately elliptical in shape (e.g., oval).

[0198] In some examples, the plenum chamber 3200 shown in FIGS. 7-14 may include one or two inlet ports 3240 on the lateral side 3210 of the shell for connection to the conduit headgear. It is understood that any of the features described herein of the seal forming structure 3100 (e.g., those of the plenum chamber 3200 shown in FIGS. 7-48) may be employed within a patient interface including the conduit headgear.

[0199] In the examples shown in FIGS. 49-56, the upper peripheral portion of each inlet port 3240 is formed by the lateral support portion 3151 of the nose portion 3230. In an example where the inlet port 3240 connects to the headgear conduit, it is advantageously possible to make the connection from the plenum chamber 3200 to the headgear conduit at an upper location of the plenum chamber 3200. This allows for a shorter conduit, a more favorable force vector and / or a smaller conduit footprint on the patient's face compared to an inlet port 3240 provided at a lower location of the plenum chamber 3200.

[0200] In one example, the plenum chamber 3200 is connected to a frame and supported in front of the patient's face via a positioning and stabilization structure 3300 (e.g., a headgear). The connection to the frame may be a snap-fit connection. Alternatively, this connection may be a press-fit, bayonet connection or other suitable connection.

[0201] In one example, the frame 3350 includes snap-fit hooks 3351 that are fitted via the rim of the shell 3210. In some examples, two snap-fit hooks 3351 are provided to the frame snap via a rim 3218 provided to the air inlet port 3240 of the plenum chamber 3200. FIG. 87 is a cross-sectional view of the connection in a horizontal plane between the frame 3350 and the plenum chamber 3200, showing the horizontal snap-fit hooks 3351 snapped via the rim 3218 of the air inlet port 3240. In this example, the two snap-fit hooks 3351 face horizontally opposite on the air inlet port 3240. In other examples, the arms face vertically opposite. (For example, at the 9 o'clock and 3 o'clock positions around the air inlet 3240) Providing snap-fit arms corresponding horizontally provides an advantage in resistance to disengagement when a lateral force is applied on the plenum chamber 3200 or the frame 3350. FIG. 88 is a cross-sectional view of the connection in a vertical plane between the frame 3350 and the plenum chamber 3200, showing the lack of a snap-fit connection on the side vertically opposite the connection. Since the patient may sleep with their head turned sideways, the plenum chamber 3200 is more likely to receive lateral forces than vertical forces during use. The horizontally opposing snap-fit connection allows the patient to rotate the plenum chamber 3200 upward or downward relative to the frame 3350 to disassemble it, but the likelihood that the plenum chamber 3200 will become disengaged from the frame due to lateral forces on the plenum chamber 3200 during use is low.

[0202] 5.3.1.3 Seal forming structure

[0203] In one aspect of the present technology, the seal forming structure 3100 can provide a target seal forming area and further provide a cushioning function. The target seal forming area is an area where sealing can occur in the seal forming structure 3100. The area where sealing actually occurs (i.e., the actual sealing surface) can vary daily by the patient in a given treatment session depending on a range of factors (e.g., the placement position of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face).

[0204] In one aspect, the target seal forming area is disposed on the outer surface of the seal forming structure 3100.

[0205] In a particular aspect of the present technology, the seal forming structure 3100 is composed of a biocompatible material (e.g., liquid silicone rubber (LSR)).

[0206] The seal forming structure 3100 according to the present technology can be composed of a soft, flexible, and elastic material (e.g., liquid silicone (LSR)).

[0207] In a particular aspect of the present technology, a system is provided that includes more than one seal forming structure 3100. Each seal forming structure 3100 is configured to accommodate different sizes and / or ranges of shapes. For example, the system can include one form of the seal forming 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.

[0208] 5.3.1.3.1 Sealing mechanism

[0209] In one aspect, the seal forming structure 3100 includes a sealing flange that uses a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to the system positive pressure within the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilization structure.

[0210] In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm (e.g., from about 0.25 mm to about 0.45 mm). This member extends around the peripheral length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral portion of the plenum chamber 3200 and extends around at least a portion of the peripheral length. The support flange is a spring-like element or includes a spring-like element and functions to support the sealing flange so that it does not buckle during use.

[0211] In one form, the seal forming structure may include a compression seal or a gasket seal. During use, the compression seal or the gasket seal is constructed and arranged to be in a compressed state, for example, due to elastic tension in a positioning and stabilizing structure.

[0212] In one form, the seal forming structure includes a tension portion. During use, the tension portion is held in a taut state, for example, by an adjacent region of the sealing flange.

[0213] In one form, the seal forming structure includes a region having an adhesive surface or an adherent surface.

[0214] In certain forms of the technology, the seal forming structure may include one or more of a pressure assist sealing flange, a compression seal, a gasket seal, a tension portion, and a site having an adhesive surface or an adherent surface.

[0215] 5.3.1.3.2 Nasal Region

[0216] In certain forms of the technology, the seal forming structure 3100 includes a central portion configured to form a seal against the lower surface of a patient's nose. The central portion may seal the lower peripheral portion of the patient's nose (e.g., around the patient's nostrils and the patient's upper lip). In an example, the seal forming structure 3100 may be configured to contact the patient's face below the nasal bridge or below the tip of the nose.

[0217] As shown in FIGS. 34 to 80 and FIGS. 158 to 183, the seal forming structure 3100 includes a central portion configured to seal the periphery of the lower side of the patient's nose during use, and an intermediate portion configured to be disposed adjacent to or on the patient's nasal wings during use. More specifically, the central portion includes an upward-facing central portion 3111 and a forward-facing central portion 3115. Most or all of the contact between the central portion and the patient's nose is made by the upward-facing central portion 3111. Further, the intermediate portion includes an upward-facing intermediate portion 3121 and a forward-facing intermediate portion 3125. Most or all of the contact between the intermediate portion and the patient's nose is made by the upward-facing intermediate portion 3121.

[0218] It is understood that the actual amount of contact of the seal forming structure 3100 with the patient's face depends on the particular implementation of the technology and the anatomical structure of the particular patient. The seal forming structure 3100 of the plenum chamber 3200 shown in FIGS. 158 to 164 (small plenum chamber 3200) and FIGS. 165 to 171 (medium plenum chamber 3200) is configured for use by patients with long noses and narrow noses. In contrast, the seal forming structure 3100 of the plenum chamber 3200 shown in FIGS. 172 to 176 (small wide plenum chamber 3200) and FIGS. 177 to 183 (wide plenum chamber 3200) is configured for use by patients with relatively short noses and relatively wide noses. In the small and medium plenum chambers 3200 shown in FIGS. 158 to 171, the upward-facing intermediate portion results in more contact with the lateral lower surface 3121 of the patient's nose (than in the case of the small wide and wide plenum chambers 3200 shown in FIGS. 172 to 183). This is because patients using the small and medium plenum chambers 3200 may generally have narrower noses, and the small and medium plenum chambers 3200 may have a larger recess in the nose portion 3230 of the seal forming structure 3100. In each of these particular examples of the technology, the upward-facing central portion 3111 enables contact between most of the lower surface of the patient's nose.

[0219] The upper lip portion 3116 can also significantly contact the lower surface of the patient's nose together with the patient's upper lip. In some examples, most of the seal formed by the lower peripheral portion of the patient's nose from the seal forming surface 3100 can be constituted by the upward-facing central portion 3111 and the upper lip portion 3116. The upward-facing central portion 3111 and the upper lip portion 3116 can each be less rigid than other portions 3100 of the seal forming structure, which is provided by a thinner wall thickness than other portions of the seal forming structure 3100 in some examples of the present technology. The lower surfaces of the patient's nose and upper lip can have a complex geometry and can also be highly sensitive to pressure. Therefore, it is advantageous to make the regions of the plenum chamber 3200 that contact or are sealed against these positions flexible and compliant, and excessive pressure generation on the face in these regions is avoided. In these examples, the low rigidity enabled by the thin wall thickness in the central portion of the nose portion 3230 of the seal forming structure 3100 near the nose hole 3272 allows the cushion to easily deform to seal the lower surface of the patient's nose (e.g., the front tip point, the lateral sides, and the alae nasi of either the upper lip). FIG. 110 is a cross-sectional view of the plenum chamber 3200 in sealing contact with the lower peripheral portion of the patient's nose 1000. While the overall shape and structure of the outward-facing regions of the nose portion 3230 (e.g., the rear corner portion 3131, the forward-facing intermediate portion 3125, and the forward-facing central portion 3115) are generally maintained during use, the more flexible upward-facing central portion 3111 can conform to the lower peripheral portion of the patient's nose.

[0220] The thin wall thickness of the upward-facing central portion 3111 and the upper lip portion 3116 enables the seal forming structure to expand at these sites to conform to the geometry of the lower surface and the peripheral portion of the patient's nose. As shown in FIG. 110, thinning the walls of the seal forming structure 3100 within the upward-facing central portion 3111 and the upper lip portion 3116 is advantageous in generating a good seal against the complex geometry in the lower and surrounding areas of the nose. This thin wall can deform and expand under pressure and conform to the surface of the patient's face to generate an effective and comfortable seal.

[0221] The central region 3111 facing upward and forward above the nasal cavity 3272 of the seal-forming structure is intended to seal the lower side and partially the front of the patient's nasal tip point. Since the nasal tip point can be a relatively sensitive area in many patients, the wall thickness of this region of the seal-forming structure 3100 can be made thinner. The central part can extend from the central part 3111 facing upward behind the cushion (i.e., facing the patient) side through the central saddle part 3112 and the peripheral edge into the central part 3115 facing forward on the front side (i.e., not facing the patient) of the seal-forming structure. By thinning the wall thickness of this region, excessive pressure application on the sensitive nasal tip point region is avoided.

[0222] The upper lip part 3116 of the seal-forming structure 3100 is intended to seal the upper lip. The upper lip part 3116 is provided in the center and below and behind the nasal cavity 3272. The upper lip part 3116 can include low wall rigidity. In some examples, the low wall rigidity is obtained by a thin wall thickness. Similar to the region of the seal-forming structure 3100 intended to seal the nasal tip point, since the upper lip can be a sensitive area, the thin wall thickness extends across the central lower / rear region of the nasal part 3230 of the seal-forming structure 3100. Due to the thin wall thickness, a lower force can be applied to the upper lip than when applied from a relatively thick wall thickness.

[0223] Maintaining a thin wall thickness in the regions configured to contact the sensitive nasal tip point and upper lip regions results in comfort and is advantageous. However, in the examples of the present technology, the wall thickness in these regions is not reduced to the extent that the seal-forming structure 3100 cannot maintain a stable seal to the patient's face. If the wall thickness in these regions is too thin, folds are likely to occur in the seal-forming structure, leading to seal failure and the generation of leakage paths, and air can flow to the surroundings between the patient's face and the cushion.

[0224] The upward-facing intermediate portion 3121 can be disposed around some or all of the periphery of the lower side of the patient's nose during use. For example, the upward-facing intermediate portion 3121 can be configured to be disposed immediately outside the patient's nose (e.g., adjacent to or in contact with the nasal wing) at the base of the nose. The upward-facing intermediate portion 3121 of the seal-forming structure 3100 can include a pair of outer walls that face partially in the intermediate direction and partially in the upward direction (e.g., having outer surfaces and outer faces that face in the intermediate direction and the upward direction) and, in some examples, partially in the rearward direction. As shown in FIG. 113, the upward-facing intermediate portion 3121 of the nasal region 3230 is disposed adjacent to the periphery of the lower side of the patient's nose 1000. The rigidity of the seal-forming structure 3100 is higher in the upward-facing intermediate portion 3121 than in the central portions 3111 and 3115. In these examples, the wall thickness of the seal-forming structure 3100 is thicker in the intermediate portions 3121 and 3125 than in the central portions 3111 and 3115 and the upper lip portion 3116.

[0225] In various examples of the present technology, generally, to make the rigidity of a region of the seal-forming structure 3100 higher than the rigidity of other regions of the seal-forming structure 3100, a greater wall thickness, a higher-rigidity material (e.g., a higher durometer silicone or other material), a reinforcement structure (e.g., a tie or rib, an under-cushion, a site or chassis, etc.) can be used.

[0226] In the examples of FIGS. 34-38 and FIGS. 76-80, the nasal region has a central saddle portion 3112 that can seal a region in front of or below the tip of the patient's nose in addition to the upward-facing central portion 3111. In these examples, these intermediate portions are provided on the lateral sides of the nasal region 3230 of the seal-forming structure 3100 on either side of the upward-facing central portion 3111, but are not provided on the central saddle portion 3112. The central saddle portion 3112 includes the same low rigidity as the upward-facing central portion 3111 and the forward-facing central portion 3115 in these examples of the present technology.

[0227] The wall thickness of the central portion 3111 facing upward, the central portion 3115 facing forward, and / or the upper lip portion 3116 of the seal formation structure 3100 can be 0.15 to 0.4 mm (for example, 0.2 mm to 0.3 mm (for example, 0.25 mm)). The wall thickness of the intermediate portion 3121 facing upward and the intermediate portion 3125 facing forward can be 0.5 mm to 1 mm (for example, 0.6 mm to 0.9 mm (for example, 0.75 mm)).

[0228] In some examples, the intermediate portion 3121 facing upward of the seal formation structure 3100 strengthens the central portion 3111 facing upward of the seal formation structure 3100. In a further example, the intermediate portion 3121 facing upward provides a barrier against the folds, avoiding a situation where a leakage path is formed within the seal formation structure 3100. Further, the intermediate portion 3121 facing upward provides flexibility and support against lateral loading onto the plenum chamber 3200, which can assist in avoiding seal breakage under lateral forces.

[0229] Since the central portion 3111 facing upward has a thin wall thickness and is thus extremely flexible, folds are likely to occur depending on the conditions. The intermediate portion 3121 facing upward has a larger wall thickness and is thus more rigid than the central portion 3111 facing upward, and thus the likelihood of folds occurring is also lower. In some examples, in the case of the nose portion 3230 of the seal formation structure 3100, folds are particularly likely to occur in the vicinity of the lateral side of the patient's nose. If a fold begins to form in the seal formation surface and continues outside the seal formation surface, a leakage path can occur due to the fold, and gas can leak from the inside of the plenum chamber 3200 through the fold to the surroundings and pass through the patient's face.

[0230] In some examples, the upwardly facing intermediate portion 3121 resists the folds of the seal forming structure 3100 due to its high wall rigidity. When a fold occurs within the upwardly facing central portion 3111 of the seal forming structure 3100, the fold size may be limited due to the upwardly facing intermediate portion 3121 and / or the thicker rear corner region 3131, thereby avoiding a situation where the fold continuously moves upward the side facing the patient of the nose portion 3230 and passes through the seal forming surface (e.g., a part of the periphery of the patient's nose). Therefore, by being disposed at or near the edge of the patient's nasal ala around the base of the nose, the upwardly facing intermediate portion 3121 functions as a barrier against folds that closely follow the shape of the patient's nose. FIG. 116 shows the plenum chamber 3200 together with various portions of the seal forming structure 3100 described in various ways. As shown, the fold 3110 is formed within the upwardly facing central portion 3111, but the upwardly facing intermediate portion 3121 and the rear corner portion 3131 effectively provide a barrier to avoid a situation where the fold 3110 propagates outward and forms a leakage path through the seal formed with the patient's face. The rear corner portion 3131 may provide a barrier to the downward and lateral fold 3110 relative to the upwardly facing central portion 3111. The upwardly facing intermediate portion 3121 may provide a barrier to the upward and lateral fold 3110 relative to the upwardly facing central portion 3111.

[0231] Furthermore, the intermediate portion 3121 or 3125 may assist in resisting or avoiding a situation where a fold is formed within the thinner central portion 3111 or 3115. When the patient wears the patient interface 3000, the intermediate portion may extend the thinner central portion onto the base of the nose (e.g., to the lower peripheral portion). Due to the increased deformation resistance by the intermediate portion near the patient's nasal ala, extending the central portion onto the base of the nose may enable resistance to or avoidance of a situation where a fold is formed within the central portion.

[0232] The seal forming structure 3100 may also include a laterally facing rear portion 3141 on a region of the nasal portion 3230 of the seal forming structure 3100 that does not face the patient laterally. The laterally facing rear portion 3141 of the nasal portion 3230 may be more rigid than the upward facing intermediate portion 3121 and the forward facing intermediate portion 3125. The laterally facing rear portion 3141 may have a greater wall thickness than the intermediate portion, the central portion, and / or the upper lip portion 3116.

[0233] The upward facing intermediate portion 3121 is arranged to contact the sides of the patient's nose when the patient wears the patient interface 3000, but also has flexibility such that it can be deformed laterally due to the patient's nose. In use, the seal forming structure 3100 is biased at the upward facing intermediate portion 3121 to contact the patient's nasal alae. When the patient wears the patient interface 3000, an outward force is applied from the patient's nose onto the side portion of the seal forming structure 3100. As a result, the side portion of the seal forming structure 3100 in the nasal portion 3230 conforms to the periphery of the patient's nose to form a stable and robust seal. FIGS. 112 and 113 show the nasal portion 3230 before and after the patient 1000 wears the patient interface 3000. As shown, the seal forming structure 3100 is shaped within the nasal portion 3230 to conform to the lower peripheral portion of the patient's nose when the patient 1000 wears the patient interface 3000. FIG. 113 shows the seal forming structure 3100 in the upward facing central portion 3111 adjacent to the upward facing intermediate portion 3121 conforming to the periphery of the patient 1000's nose to form a good seal. The rigidity of the seal forming structure 3100 within the upward facing intermediate portion 3121 is advantageously large enough for the nasal portion 3230 to conform to and produce a robust seal with a narrow nose and is not so highly rigid as to be uncomfortable for a wider nose.

[0234] Furthermore, the forward load on the side of the nose provided by the upwardly facing intermediate portion 3121 enables decoupling between the patient's nose and the remainder of the plenum chamber 3200 and the patient interface 3000, and enables the plenum chamber 3200 to withstand a certain lateral movement of some parts (e.g., the shell 3210) during use without interfering with the seal. FIG. 114 shows the seal forming structure 3100 in sealing contact with the patient 1000's nose without lateral displacement of the plenum chamber 3200. FIG. 115 shows the same view as FIG. 114, but after the seal forming structure 3100 has been laterally displaced (e.g., by tube traction). As shown in FIG. 115, by biasing the seal forming structure 3100 into contact with the patient 1000's nose, the state where the seal forming structure 3100 is in sealing contact with both sides of the nose is maintained even when the plenum chamber 3200 is displaced relatively greatly.

[0235] In these examples, as shown in FIGS. 7-8, FIGS. 49-50, FIGS. 128-129, FIGS. 138-139, FIGS. 146-147, FIGS. 154-155, the nose portion 3230 of the seal forming structure 3100 includes two lateral portions 3231. Each lateral portion 3231 of the nose portion 3230 may include a side facing the patient and a side not facing the patient. The side facing the patient may face in the intermediate and rear directions, and the side not facing the patient may face in the lateral and front directions. Both the side facing the patient and the side not facing the patient may partially face upward. The side facing the patient of the lateral portion 3231 of the nose portion 3230 may include a part of the upwardly facing central surface 3111 and an adjacent upwardly facing intermediate portion 3121. The side not facing the patient of the lateral portion 3231 of the nose portion 3230 may include a forwardly facing intermediate portion 3125 and a laterally facing rear portion 3134.

[0236] In some examples of the present technology, the lateral portion 3231 of the nasal portion 3230 of the seal-forming structure 3100 can be higher in height than in other examples of the present technology. That is, the lateral portion 3231 can protrude from the oral portion 3260 by a greater distance upward during use. The plenum chambers 3200 shown in FIGS. 7-8 and FIGS. 49-50 include a tall lateral portion 3231 within the nasal portion 3230. These plenum chambers 3200 can fit well to patients including those with a relatively long nose, a narrow nose, and / or a nose with longer alae than nasal septum. The plenum chambers 3200 shown in FIGS. 128-129 and FIGS. 138-139 include the lateral portion 3231 within the nasal portion 3230. These lateral portions 3231 are not as tall as the examples shown in FIGS. 7-8 and FIGS. 49-50, but are of medium height. These lateral portions 3231 can also fit well to patients with long and narrow noses. The lateral portions 3231 shown in FIGS. 146-147 and FIGS. 154-155 have a shorter lateral portion 3231 within the nasal portion 3230. These plenum chambers 3200 can fit well to patients with a wider nose, a shorter nose, and / or a flatter nose.

[0237] The anterior region of the nasal portion 3230 is configured to be comfortable while being able to form a stable seal against the patient's nose.

[0238] In some examples, the thickness of the front-facing central portion 3115 is approximately 0.15 to 0.4 mm (e.g., 0.2 to 0.3 mm), and in the illustrated example, the wall thickness is approximately 0.25 mm. The front-facing intermediate portion 3125 may include a wall thickness greater than the wall thickness in the front-facing central portion 3115, and may be 0.5 mm to 1 mm (e.g., 0.65 mm to 0.85 mm) or approximately 0.75 mm in the illustrated example. In some examples, the thickness of the seal-forming structure 3100 is tapered between regions having different thicknesses. In other examples, the thickness changes relatively abruptly (e.g., stepwise). The front region of the nose portion 3230 is configured to be somewhat compliant, so it is not as thick and highly rigid as other regions of the nose portion 3230 (e.g., the rear corner portion 3131 of the nose portion 3230 (where the thickness is in the range of 1 to 1.5 mm)). The front region of the nose portion 3230 may have a sufficient thickness to be highly rigid enough to maintain its overall shape when worn by a patient.

[0239] By making the front portion of the nose portion 3230 flexible, the seal-forming structure 3100 can be somewhat deformed when receiving the patient's nose (especially a long nose). FIG. 117 shows the plenum chamber 3200 in sealing contact with the face of a patient 1000 with a short nose. FIG. 118 shows the plenum chamber 3200 in sealing contact with the face of a patient 1000 with a long nose. In this example, the seal-forming structure 3100 can be deformed over a wider range to accommodate a longer nose. This can be achieved without adversely affecting the patient's comfort. The tip of the patient's nose can be a particularly sensitive area, and the flexibility of the front portion of the nose portion 3230 can assist in reducing the force applied from the seal-forming structure 3100 to the patient's nose. This flexibility is particularly advantageous at the position of the tip of the nose, so the central portion is less rigid than the front-facing intermediate portion 3125. The upward-facing central portion 3111 and the front-facing central portion 3115 may have a thickness of about 0.25 mm, and the front-facing intermediate portion 3125 may have a wall thickness of about 0.75 mm. By reducing the thickness of the central portion, the pressure on the tip of the nose is reduced, and the thicker intermediate portion 3125 provides a certain support to the overall structure of the nose portion 3230.

[0240] As a further advantage of the flexible central region of the nasal portion 3230, when a patient wears the patient interface 3000 and a downward force is applied onto the central portion 3111 facing upward from the patient's nose above the seal-forming structure, it is possible to pull the side portions of the nasal portion 3230 inward (e.g., in the intermediate direction). By pulling the side portions of the nasal portion 3230 inward toward the sides of the patient's nose, the seal-forming structure 3100 is pulled into and around the lower peripheral portion of the patient's nose, enabling seal improvement. FIG. 113 shows the seal-forming structure 3100 conforming to the periphery of the patient's nose.

[0241] Although the lateral sides of the nasal portion 3230 are pulled inward, the forward-facing intermediate portion 3125 on either side of the front portion and in particular the more flexible forward-facing central portion 3115 retains sufficient structural rigidity for maintaining the overall shape of the seal-forming structure 3100 and avoiding the occurrence of leakage paths due to folds. In another example, since the forward-facing central portion 3115 can have a thickness similar to that of the forward-facing intermediate portion 3125, further fold resistance is obtained at the central saddle portion 3112 of the nasal portion 3230.

[0242] The nose portion 3230 of the seal formation structure 3100, and in particular the area between the nasal hole 3272 and the central saddle region 3112 of the nose portion 3230, is advantageously relatively long in the front and rear directions. This portion of the nose portion 3230 of the seal formation structure 3100 is not as well supported as other regions. The elongated region in this portion of the seal formation structure 3100 provides sufficient space for deformation of the nose portion 3230 of the seal formation structure 3100, which is advantageous when the seal formation structure 3100 receives the nose. If the seal formation structure 3100 has a more rigid structure in this region, excessive force can be applied onto the patient's nasal tip point (especially for a longer nose). Since the nasal tip point can be a particularly sensitive area, avoiding such excessive force is advantageous in terms of comfort. However, there are also patients with noses that can be shorter and relatively wider. The plenum chambers 3200 shown in FIGS. 142 - 149 and FIGS. 150 - 157 are suitable for patients with shorter noses. These plenum chambers 3200 include a nose portion 3230 with a shorter length between the upper lip portion 3116 and the central saddle region 3112. These plenum chambers 3200 also have a surface within the upward-facing central portion 3111 between the aperture 3272 and the central saddle region 3112, and can receive the nasal tip point in a comfortable manner for the patient, but are not as long as between the upper lip portion 3116 and the central saddle region 3112. This is because the plenum chambers 3200 shown in FIGS. 126 - 133 or FIGS. 134 - 141 are more suitable for patients with longer noses. The plenum chambers 3200 shown in FIGS. 126 - 133 and FIGS. 134 - 141 also include a central saddle region 3112 that is disposed forward of the chassis 3210 compared to the central saddle region 3112 of the plenum chamber 3112 shown in FIGS. 142 - 149 and FIGS. 150 - 157.

[0243] The central portion 3111 facing upward above the nose portion 3230 of the seal forming structure 3100 has a bridge portion 3113 that connects the front region of the upward-facing central portion 3111 to the upper lip portion 3116 of the nose portion. Therefore, the bridge portion 3113 is disposed below the nasal column of the patient during use and partially defines two nasal apertures 3272 (one on either lateral side). Through these nasal apertures 3272, air supply to the patient can be performed.

[0244] The bridge portion 3113 is flexible and curved so as to be loose when the patient is not wearing the patient interface 3000. Due to the looseness of the bridge portion 3113, when the patient wears the patient interface 3000, the front portion of the central portion 3111 (the front of the bridge that contacts the nasal tip point of the patient during use) can move in a direction away from the upper lip portion 3116.

[0245] Advantageously, this also enables the seal forming structure 3100 to comfortably accommodate a nose of a longer length. A longer and / or narrower nose can comfortably push out the front portion of the upward-facing central portion 3111 forward. By deforming the nose portion 3230 in this way, it becomes possible to hold the force reapplied from the seal forming structure 3100 onto the patient's nasal tip point (which is generally extremely sensitive) to a significant level. FIGS. 117 and 118 show a plenum chamber 3200 having a bridge portion 3113 and a seal forming structure 3100. The bridge portion 3113 is formed to be relaxed and is worn by patients 1000 having both short and long noses. As shown in FIG. 117, since the front portion of the upward-facing central portion 3111 is not pushed out forward to a significant extent by the nose of patient 1000, the bridge portion 3113 is generally curved and relaxed. However, as shown in FIG. 118, with a longer nose, the front portion of the upward-facing central portion 3111 is pushed out forward to the extent that the bridge portion 3113 extends into a more linear configuration. Therefore, the bridge portion 3113 is advantageous in that it enables the seal forming structure to accommodate a range of nose sizes while maintaining comfort and achieving a good seal.

[0246] Since the bridge portion 3113 can be S-shaped, it can withstand the movement in the separation direction from the upper lip portion 3116 of the central portion 3111 that becomes linear and faces upward of the seal forming structure 3100. The bridge portion 3113 may be arcuate, may be curved, or may be folded. The bridge portion 3113 may have a bellows or a bellows. The bridge portion 3113 may include only one curve so that the bridge is C-shaped, or may include two bows so that it is S-shaped to obtain more relaxation. The bridge portion 3113 may be in a sling shape (for example, a portion suspended between ends). The bridge portion 3113 is longer and includes more material than the material necessary to fill the gap between the front portion and the rear portion of the central portion 3111 that faces upward of the nose portion 3230. By using such extra material, it becomes possible to extend the bridge portion 3113 from being linear until it is taut. The more such extra material there is, the more the bridge portion 3113 can be extended until it is taut due to the force applied to the front portion of the central portion 3111 facing upward. Since the bridge portion 3113 does not need to seal the patient's nasal column to completely seal the patient's nose, even when the bridge portion 3113 is in a slightly relaxed state, it is possible to provide a good seal for a small nose.

[0247] The thickness of the bridge portion 3113 can be about 0.2 mm to 0.45 mm or 0.3 to 0.4 mm (for example, 0.35 mm). Since the material thickness of the bridge portion 3113 is larger than the material thickness of the central portion 3111 facing upward around the seal forming structure 3100, resistance to breakage of the bridge portion 3113 or avoidance of breakage of the bridge portion 3113 is assisted. Alternatively, the bridge portion 3113 may be made wider and thinner. In one example, a thicker and narrower bridge portion 3113 is provided so that the nasal hole 3272 becomes relatively large.

[0248] The bridge portion 3113 can also be used for other purposes. For example, the bridge portion 3113 can maintain the integrity in the thin-walled zone of the central portion 3111. If there is a single nasal aperture instead of the bridge portion 3113, due to the relatively thin wall thickness of the central portion, when the seal-forming structure is reattached under pressure (e.g., via face pulling and repositioning) or when the seal-forming structure undergoes rapid dynamic loading, rupture may occur in the upward-facing central portion 3111. By fastening the upward-facing central portion 3111 to the upper lip portion 3116 by the bridge portion 3113, the possibility of rupture in the upward-facing central portion 3111 is reduced.

[0249] Furthermore, the bridge portion 3113 can assist in avoiding situations where the patient inaccurately sets the patient interface 3000. If there is a single nasal aperture instead of the bridge portion 3113 being provided, there is a possibility that the patient may accidentally insert their nose into the nasal aperture. In some examples, since the seal-forming structure 3100 is configured to seal around the lower side of the patient's nose, if the patient inserts their nose into the nasal aperture, the seal-forming structure may not be able to achieve an appropriate seal.

[0250] Despite the advantages of the bridge portion 3113 in some forms of the present technology, in some alternative examples, the bridge portion 3113 is not provided, and only a single hole is provided within the nose portion 3230 of the seal forming structure 3100. This allows the central portion 3111 facing upward of the nose portion 3230 to move relative to the lower portion, facilitating the cleaning of the seal forming structure 3100. However, if the central portion 3111 facing upward of the seal forming structure 3100 is not fastened to the upper lip portion 3116, there may be an increased risk of rupture for some patients. Additionally, there is a possibility that the patient may insert their own nose into the single hole. (For example, by providing the seal forming structure with a thicker, smaller or more closely fitting membrane around the hole), steps are taken to mitigate these risks. Thereafter, a single hole (i.e., without a bridge) may be provided in some examples of the present technology. The seal forming structure 3100 of the patient interface 3000 according to an example of the present technology may include one or two apertures for providing an air flow to the patient's nasal passage.

[0251] Within the region of the seal forming structure 3100 described above, while it is advantageous to be able to comfortably conform to a complex geometry by thinning the wall thickness of the seal forming structure 3100, in some regions of the seal forming structure 3100, a relatively larger wall thickness is advantageous in other forms of the present technology.

[0252] For example, the nose portion 3230 of the seal forming structure 3100 includes rear corners 3131 configured to seal the patient's face in the vicinity of the nasolabial groove. These rear corners 3131 have a greater wall thickness compared to the central portion of the nose portion 3230 of the seal forming structure 3100. By making the wall thickness greater in this way, the structural rigidity of the seal forming structure 3100 within these regions can be made significant, and a plurality of advantages can be obtained.

[0253] The rear corner portion 3131 needs to have sufficient structural rigidity so as not to collapse and compromise the seal achieved by the central portion (e.g., the upward-facing central portion 3111 and / or the upper lip portion 3116) of the seal-forming structure 3100 in order to support the seal-forming structure on the patient's face. In another example, the rear corner portion 3131 includes an under-cushion for reinforcement. In the illustrated example where a single-wall seal-forming structure 3100 is provided, the structural rigidity is provided by a sufficiently large wall thickness, and the thickness in one example can be about 0.8 to 1.6 mm (e.g., 1.1 mm to 1.45 mm or 1.25 mm). The rear corner portion 3131 is configured to be disposed in the region of the patient's face and the lower and laterally outward side of the patient's nose within the region below the patient's nasal wing (e.g., between the nasolabial groove and the region of the upper lip disposed below the nasal wing).

[0254] As shown in FIGS. 27, 34, 69, and 76, there is a sharp transition (e.g., a sharp taper or step) between the greater wall thickness in the rear corner portion 3131 and the thin wall thickness in the upper lip portion 3116 of the seal-forming structure 3100 (i.e., the region sealing the upper lip). When support is necessary / advantageous in the state where the upper lip portion 3116 is disposed in a sealed state with respect to the patient's upper lip, the thick rear corner portion 3131 provides support for the seal-forming structure, and this rear corner portion 3131 can be significantly flexible to conform to the outer shape of the patient's face while minimizing the force. Since the facial geometry can vary greatly from patient to patient, the sharp transition can be disposed almost directly from below to the nasal wing on the upper lip.

[0255] In some examples of the present technology, the seal-forming structure 3100 includes a lateral corner region 3114 that forms a central portion. These lateral corner regions 3114 are configured to contact and seal the nasal wings. As shown in FIGS. 34, 76, 160, 161, 164, 168, and 170, above the position of the joint between the thicker one of the rear corner portions 3131 and the thinner wall thickness in the upper lip portion 3116 of the nose portion 3230 of the seal-forming structure 3100, there is a lateral corner region 3114 of the upward-facing central portion 3111, which extends to either side of the target seal-forming region in the lateral, rearward, and upward directions (for example, extends upward on the side facing the intermediate direction of the seal-forming structure 3100). The nasal wings can be significantly curved, and in many patients, in a largely sunken pocket or recess, the nasal wings may be connected to the face. These pocket portions can be due to the nasal wings that curve back in the intermediate direction (for example, toward the sagittal plane) between the widest part of the nose and the junction of the nasal wings and the face. By providing the low rigidity achieved by the thin wall thickness in these lateral corner regions 3114, the seal-forming structure 3100 can be deformed to conform to the curvature of the nasal wings. Such flexibility and the ability to conform can assist in filling the recesses that may be present in the lower corner portion of the patient's nose with the seal-forming structure 3100.

[0256] The seal forming structure 3100 can be configured such that each transition between the thick rear corner portion 3131 and the thin upper lip portion 3116 is disposed adjacent to the nasal wing on the patient's face in the lateral direction of the nasal wing. The region of the seal forming structure 3100 that contacts the patient's face on any lower lateral portion of the nose can be part of the thick rear corner portion 3131 so as to provide good support and stability to the seal forming structure 3100. FIG. 111 shows a sectional view of a plenum chamber 3200 according to an example of the present technology in a sealed position on the patient's face. The upward-facing central portion 3111 seals the lower peripheral portion of the patient 1000's nose, and the upper lip portion 3116 seals the patient's upper lip. The upward-facing intermediate portion 3121 is disposed adjacent to the side portion of the patient's nose (e.g., adjacent to the nasal wing). Further, the lateral corner region 3114 of the upward-facing central portion 3111 can be deformed to receive the patient's nasal wing. For example, the lateral corner region 3114 can cup the patient's nasal wing. The lateral corner region 3114 can create a shelf in the cushion to support the adjacent area of the patient's nasal wing during use, enabling the seal forming structure 3100 to fit well to the lower peripheral portion of the patient's nose (especially in the vicinity of the upper lip) during use.

[0257] As shown in FIG. 111, the boundary between the thick wall forming the rear corner portion 3131 and the intermediate adjacent portion of the seal forming structure 3100 can be traced upward, outward, and then inward, whereby the curvature of the patient's nose can be followed in the upward direction starting from below the patient's nasal wing. The intermediate boundary of the wall forming the thick rear corner portion 3131 can follow the path above the patient's face along the curvature on either side of the nose. This enables the thinner portions (e.g., the upward-facing central portion 3111 and the upper lip portion 3116) to fit and seal to the nasal wing and the lower side of the patient's nose, while being able to support well (e.g., the patient's face immediately below the patient's nose and the patient's face on either side of the patient's nose) when necessary.

[0258] As shown in the side views illustrated in, for example, FIGS. 18, 19, 30, 31, 32, 38, 58, and 80, the seal forming structure 3100 becomes even thicker toward the front side portion proximate to the shell 3210 (the shell 3210 shown in FIGS. 9 and 51 but not shown in FIGS. 38 or 80). As described above, the seal forming structure 3100 includes a lateral support portion 3151 that takes the form of a thickened region on a laterally facing portion that is partially forward facing on the nose portion 3230 of the seal forming structure 3100. The thicker region of the seal forming structure 3100 proximate to the shell 3210 provides good support and structural rigidity of the seal forming structure 3100.

[0259] Although the thickened region proximate to the shell 3210 is advantageous for obtaining structural rigidity, the nose portion 3230 of the seal forming structure 3100 also retains a certain level of flexibility to allow the sides of the seal forming structure 3100 to be pressed outwardly or pulled inwardly to accommodate noses of different widths.

[0260] For example, the side or region of the nose portion 3230 of the seal forming structure 3100 that does not face the patient (e.g., the front side portion, the side portion that is at least partially forward facing) (in particular, the region that does not contact the patient on either side of the nose portion 3230 of the seal forming structure 3100) is thick enough to impart sufficient structural rigidity to the seal forming structure 3100 and is thin enough such that when a patient with a long and narrow nose wears the seal forming structure 3100, the downward force acting on the central region 3111 that faces upward from the patient's nose slightly pulls the side portions of the nose portion 3230 inwardly to enable good contact between the patient contact surface of the seal forming structure 3100 on either side of the patient's nose and the patient's nose. Similarly, since the structure of the nose portion 3230 of the seal forming structure 3100 is sufficiently flexible, when a patient with a wider nose wears the seal forming structure 3100, excessive inward force on the sides of the patient's nose (which may occur if the rigidity of the seal forming structure is too high to withstand a wider nose) is eliminated. It is also possible to provide a plurality of seal forming structures 3100 of different sizes to accommodate different ranges of nose widths.

[0261] As shown in FIGS. 7, 8, 49, 55, 126, 129, 138-139, 146, 147, 154, and 155, for example, in the oro-nasal transition 3275 in the vicinity of the plenum chamber 3200, the nasal region 3230 and the oral region 3260 are connected. The periphery of the seal-forming structure 3100 varies at this location among the examples of the present technology. As shown in FIG. 7, the oro-nasal transition 3275 is relatively abrupt, and there is a relatively large positive curvature at the periphery of the seal-forming structure 3100 between the nasal region 3230 and the oral region 3260. In contrast, as shown in FIG. 49, the oro-nasal transition 3275 is relatively gradual, and there is a relatively small positive curvature at the periphery of the seal-forming structure 3100 between the nasal region 3230 and the oral region 3260. In either case, the oro-nasal transition 3275 includes a saddle region. The plenum chambers 3200 shown in FIGS. 128, 138, 146, and 154 include a distinct and gradual oro-nasal transition 3275.

[0262] Since it is preferable that the periphery of the seal-forming structure 3100 be sufficiently highly rigid to support the overall shape of the seal-forming structure 3100 and avoid large wrinkles and buckling, the shape of the periphery can vary more than the regions that contact the patient's face and adjacent regions (i.e., the thin zones and the thicker zones that avoid the occurrence of leakage paths through the patient's face due to wrinkles). In either case, the oro-nasal transition 3275 between the nasal and oral regions of the seal-forming structure 3100 is relatively more rigid (e.g., relatively thicker) compared to the low-rigidity portions (e.g., the upward-facing central portion 3111) of the seal-forming structure 3100 in order to avoid the occurrence and generation of leakage between these regions due to wrinkles or buckling. Alternatively, the oro-nasal transition 3275 can be strengthened by any suitable means (e.g., an under-cushion, ribs, a portion of the shell, or a frame).

[0263] In some examples, the oral cavity portion 3260 of the seal-forming structure 3100 includes features for avoiding the folds. In the case of the lateral periphery of the oral cavity hole 3271, due to the downward force on the nasal portion of the cushion and the wide elliptical shape of the oral cavity opening, folds or buckling are more likely to occur above and below the oral cavity hole 3271.

[0264] In the examples shown in FIGS. 34 to 80, the seal-forming structure 3100 includes a thinner oral cavity hole peripheral portion 3117 than other portions of the seal-forming structure 3100 at the periphery of the oral cavity hole 3271. Further, the seal-forming structures in these examples include a laterally facing rear portion 3135. These laterally facing rear portions 3135 are thicker than the oral cavity hole peripheral portion 3117 and resist the folds and buckling in the cushion that can cause the formation of leakage paths. In some examples of the present technology, the seal-forming structure 3100 shown in FIGS. 126 to 157 may also include an oral cavity hole peripheral portion having a lower rigidity than the laterally facing rear portion of the oral cavity portion 3260.

[0265] In some examples, such as the plenum chamber 3200 shown in FIG. 48, the seal-forming structure includes a laterally peripheral support portion 3136 at the opposing lateral sides of the oral cavity hole 3271. In this example, the laterally peripheral support portion 3136 is formed by the laterally facing rear portion 3135. The laterally facing rear portion 3135 extends in an intermediate direction toward the most lateral edge of the oral cavity hole 3271 to provide the laterally peripheral support portion 3136. The laterally peripheral support portion 3136 further provides resistance to buckling. In some examples of the present technology, the seal-forming structure 3100 shown in FIGS. 126 to 157 may also include the laterally peripheral support portion 3136.

[0266] 5.3.1.3.3 Oral cavity region

[0267] In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that forms a seal during use on the upper lip region (i.e., the upper lip) of the patient's face. The seal-forming structure 3100 may include an upper lip portion 3116 configured to form a seal against the patient's upper lip.

[0268] In one form, the seal-forming structure 3100 includes a saddle-shaped region configured to form a seal over the upper lip region of the patient's face in use.

[0269] In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that forms a seal around the patient's mouth at the oral site 3260 in use. The seal-forming structure 3100 may form a seal over the jaw region of the patient's face.

[0270] In one form, the seal-forming structure 3100 includes a saddle-shaped region configured to form a seal over the jaw region of the patient's face in use.

[0271] As shown in FIGS. 34-80 and FIGS. 126-183, the seal-forming structure 3100 includes a lower lip portion 3118 that forms a seal against the patient's jaw region. In one example, the seal-forming structure 3100 including the lower lip portion 3118 does not extend below (i.e., inferior to) the patient's jaw or engage the patient's face below the jaw (i.e., inferior to the gonion) in use. The lower lip portion 3118 of the seal-forming structure may seal the patient's lower lip and chin. Further, in these examples, the seal-forming structure 3100 includes a perioral aperture perimeter portion 3117. The lower lip portion 3118 may be connected (e.g., adjacent) to the upper lip portion 3116 via the perioral aperture perimeter portion 3117. The seal-forming structure 3100 includes a relatively small wall thickness at the perioral aperture perimeter portion 3117 and at the lower lip portion 3118 of the seal-forming structure 3100 disposed against the jaw region (compared to other regions). Thinning the wall thickness at these locations aids in achieving an effective and comfortable seal. The seal-forming structure 3100 in these regions can readily conform to any complex geometry (e.g., the submandibular fold).

[0272] In these examples, the oral site 3260 includes a laterally extending portion 3135 that faces rearward on the side that contacts the patient of the seal-forming structure 3100. As described above, the wall thickness immediately around the oral aperture 3271 in the oral aperture peripheral portion 3117 is thinner compared to other regions of the seal-forming structure 3100. However, in these examples, in any lateral side of the oral aperture peripheral portion 3117, there is a laterally extending portion 3135 that faces rearward and is thicker than the oral aperture peripheral portion 3117. The wall thickness of these regions can be about 1 mm to 1.5 mm (e.g., 1.15 mm to 1.35 mm (e.g., a thickness of about 1.25 mm)). Since the regions that come into contact with these regions during use (i.e., the patient's cheeks) are often not as sensitive as other regions of the face, patients can often tolerate the seal-forming structure 3100 with a greater wall thickness / rigidity in these regions. Further, the laterally extending portion 3135 that faces rearward of the oral site 3260 is curved in a direction away from the contact portion with the patient's face, thereby reducing the contact area on the patient's face in these regions. In another example, instead of making the laterally extending portion 3135 that faces rearward of the oral site 3260 thicker, it may be made highly rigid by other means (e.g., a reinforcing structure (e.g., a rib), a material with higher rigidity, an under-cushion)).

[0273] The laterally extending portion 3135 that faces rearward provides resistance to the folds that may be formed in the vicinity of the oral aperture 3271, thereby avoiding the generation of leakage paths. The laterally extending portion 3135 that faces rearward provides a barrier to the folds formed in the thinner oral aperture peripheral portion 3117, thereby restricting the range of the folds in the direction away from the oral aperture 3271. This function of the laterally extending portion 3135 that faces rearward may be similar to the fold resistance function obtained by the intermediate portion 3121 that faces upward of the nasal site 3230 described above.

[0274] The lower lip portion 3118 of the oral portion 3260 is approximately half the width of the oral portion 3260 and is centered below the oral aperture 3271. As described above, the lower lip portion 3118 can be relatively thin. The transition between the thinner lower lip portion 3118 and the thicker laterally-directed portion 3135 facing rearward in either lateral side can be configured to be disposed at or near the patient's mandibular fold. The lower lip portion 3118 is wider at the periphery of the oral aperture 3271 than at the lower peripheral portion of the seal-forming structure 3100. Therefore, the width of the lower lip portion 3118 is tapered downward from the oral aperture 3271. In the examples shown in FIGS. 49 to 80, the lower lip portion 3118 extends from the side facing rearward of the seal-forming structure 3100 to the peripheral portion facing downward. The actual amount of the lower lip portion 3118 that contacts the patient's face can depend on the shape of the patient's jaw. In the case of a patient with a more forward-projecting jaw, the contact with the lower lip portion 3118 can increase. In the plenum chamber 3200 shown in FIGS. 158 to 183, the lower peripheral portion of the shell 3210 is not as low as the lower peripheral portion of the shell 3210 of the plenum chamber 3200 shown in FIGS. 49 to 80 and the seal-forming structure 3100 and the lower lip portion 3118 around the lower peripheral portion of the seal-forming structure 3100, thereby forming a portion of the lower lip portion 3118 that faces forward.

[0275] The lateral portion 3145 of the oral site 3260 is distal (e.g., closer to the shell 3210) from contact with the patient than the laterally oriented rearward portion 3135 in the lateral peripheral portion of the oral site 3260. In these examples, the lateral portion 3145 is thicker than the laterally oriented rearward portion 3135 of the oral site. In some examples, the thickness of the lateral portion 3145 of the oral site is in the range of 1.5 to 2.2 mm (e.g., 1.7 to 2 mm). Since most or all of the lateral portion 3145 has a low likelihood of contacting the patient's face during use, patient comfort is not as important a design consideration for these regions, and the wall thickness can be made greater in these regions than in the patient contact regions. Increasing the wall thickness in this way can provide structural rigidity in the overall shape of the oral site 3260 of the seal-forming structure 3100. In some examples, the more distal from the patient's face, a particular region of the seal-forming structure 3100 is thicker than that region, unless there is a reason to make that region flexible (e.g., to deform the side portion of the nasal site of the seal-forming structure 3100). The lateral portion 3145 defines the lateral peripheral portion of the seal-forming structure 3100 within the oral site 3260.

[0276] On the front side of the seal forming structure 3100, the wall thickness is generally greater than these examples, except for the front side of the nasal portion and the central lower region of the mouth portion of the seal forming structure 3100. In these examples, the seal forming structure 3100 includes a laterally directed forward portion 3155. In these examples, the wall thickness of the laterally directed forward portion 3155 is greater than that of the lateral portion 3145 (and the laterally directed rearward portion 3135). The wall thickness of the laterally directed forward portion can be in the range of 1.7 to 2.7 mm (e.g., in the range of 2.0 to 2.5 mm). These thicker regions provide substantial support and structural configuration to the overall shape of the seal forming structure 3100. The laterally directed forward portion 3155 cooperates with other portions of the seal forming structure having a thick wall thickness (e.g., the lateral portion 3145) so that the overall shape of the seal forming structure 3100 is maintained and can resist wrinkles and / or buckling, etc. The thinner region provided on the side of the seal forming structure 3100 facing the patient is pressed against the patient's face and deformed under the force applied from the positioning and stabilizing structure 3300 to the plenum chamber 3200.

[0277] On the front side of the seal forming structure 3100, a front support portion 3161 of the mouth portion 3260 is also provided. The front support portion 3161 is an even thicker zone of the seal forming structure 3100 at the base of the nasal portion on the front side (where the nasal portion is joined to the mouth portion adjacent to the frame) and at the lower lateral corner of the mouth portion 3260. The wall thickness in these regions can be in the range of 2 to 3 mm (e.g., 2.5 to 3 mm). These regions can provide additional structural rigidity to the seal forming structure. The front support portion 3165 can have a wall thickness greater than that of the laterally directed forward portion 3155. Generally, the cushion has an even greater wall thickness in a more distal direction from the seal forming region, but at the immediate position of the shell 3210, the thickness can be the same as that of the laterally directed forward portion 3155 even if the front support portion 3165 is thicker. In some examples, the silicone at the immediate position of the shell 3210 can be reinforced by the peripheral edge of the shell 3210, so the wall thickness can be small.

[0278] 5.3.1.3.4 Frontal Region

[0279] In one form, the seal-forming structure forms a seal on the frontal region of the patient's face when the seal is in use. In such a form, the plenum chamber may cover the eyes during use.

[0280] 5.3.1.3.5 Nasal Pillows

[0281] In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows. Each nasal puff or nasal pillow is configured and arranged to form a seal with each nostril of the patient's nose.

[0282] The nasal pillow according to one aspect of the present technology includes a frustum of a cone. At least a portion of the frustum of the cone forms a seal on the lower side of the patient's nose, the stem, and a flexible region on the lower side of the frustum of the cone, connecting the frustum of the cone to the stem. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the stem. The flexible region may function to facilitate a freely jointed structure. The freely jointed structure corresponds to the mutual movement of both the displacement and the angle of the frustum of the cone and the structure to which the nasal pillow is connected. For example, the frustum of the cone may be displaced axially toward the structure to which the stem is connected.

[0283] 5.3.1.3.6 Surface Finish

[0284] In some examples, different regions of the seal-forming structure 3100 include different surface finishes.

[0285] Referring to FIG. 47, the plenum chamber 3200 includes a seal-forming structure 3100 that includes a nasal portion 3230 and an oral portion 3260. The seal-forming structure includes a first surface finish within the nasal portion and a second surface finish different from the first surface finish within the oral portion. In the illustrated example, region 3101 has the first surface finish and region 3103 has the second surface finish. The boundary between the first surface finish and the second surface finish is defined by a line 3102 that may contact the patient's cheeks during use.

[0286] The coefficient of friction between the seal formation structure 3100 and the patient's face is higher in the oral region 3260 than in the nasal region 3230. The first surface finish in the region 3101 can be configured to impart a smooth feel on the patient's face to the nasal region, so it can be more comfortable. The second surface finish in the region 3103 can be configured to impart a grip contact on the patient's face to the oral region, so a more robust seal becomes possible. In some examples, the first surface finish in the region 3101 can be a matte surface finish. In some embodiments, the second surface finish in the region 3103 can be a polished surface finish. In this example, the nasal region 3230 includes the upper lip portion 3116 having the first surface finish.

[0287] Since the polished surface finish can be slippery and have a sticky feel, higher friction occurs when the seal formation structure 3100 moves relative to the patient's face. By doing so, when the patient wears the plenum chamber 3200, the avoidance of the movement of the plenum chamber 3200 is assisted, so the seal maintenance is assisted, which is generally desirable. However, the patient may consider that the feel of the polished surface finish on the face is not as comfortable as that of the low-friction surface finish that feels smoother. Since the nose is often a more sensitive area, the patient may be able to tolerate the feel of the polished finish on both sides of their cheeks and under the mouth, while not being able to tolerate the feel of the polished surface on the nose and its surroundings. Therefore, in this example, a polished finish is provided around the oral region 3260, while a matte finish is provided on the nasal region 3230 of the seal formation structure 3100. When a matte finish is provided on the nasal region 3230, the matte finish conforms to the surface around the nose, so it may be possible to assist the relative movement of the seal formation structure 3100 to the nose and also assist the seal formation.

[0288] Further, by increasing the friction within the region of the second surface finish in region 3103 to improve the grip feeling, the seal maintenance by the oral region 3260 when the patient's lower jaw is moving is supported. The jaw can move relative to the head and may tend to move downward (to be described in detail later). By improving the grip feeling, the maintenance of the seal position around the patient's mouth when the jaw is moving is supported.

[0289] The boundary 3102 between the polished finish in 3103 and the matte finish in 3101 is close to the boundary between the nasal region 3230 and the oral region 3260 of the seal forming structure 3100 (slightly closer to the oral region 3260 than the nasal region 3230). The boundary 3102 is disposed across the seal forming structure 3100 approximately perpendicular to the path on the oral region 3260 surrounding the oral hole 3271. At the periphery of the oral hole 3271, the boundary 3102 may be disposed on the upper lip. At the periphery of the oral region 3260 of the seal forming structure 3100, the boundary may be disposed close to the patient's cheekbone.

[0290] 5.3.2 Positioning and Stabilization Structure

[0291] The seal forming structure 3100 of the patient interface 3000 of the present technology can be held in the sealed position by the positioning and stabilization structure 3300 during use.

[0292] 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 for lifting off the face.

[0293] In one form, the positioning and stabilization structure 3300 provides a holding force sufficient to overcome the gravitational force on the patient interface 3000.

[0294] In one form, the positioning and stabilization structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive action on the patient interface 3000 (e.g., due to tubing snagging or accidental interference with the patient interface).

[0295] In one form 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 non - obtrusive outer shape or cross - sectional thickness so as to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross - section. In one embodiment, the positioning and stabilization structure 3300 includes at least one flat strap.

[0296] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured such that it does not have an overly large or bulky size that would interfere with a patient lying in a supine sleep position with the patient's head resting on the rear region of the patient's head on a pillow.

[0297] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured such that it does not have an overly large or bulky size that would interfere with a patient lying in a lateral sleep position with the patient's head resting on the side region of the patient's head on a pillow.

[0298] In one form of the present technology, the positioning and stabilization structure 3300 includes a decoupling portion disposed between the front portion of the positioning and stabilization structure 3300 and the rear portion of the positioning and stabilization structure 3300. This decoupling portion is not resistant to compression and can be, for example, a flexible or flimsy strap. The decoupling portion is constructed and arranged such that when the patient lies with the head on the pillow, the presence of the decoupling portion can avoid a situation where the force to the rear is transmitted along the positioning and stabilization structure 3300 and the seal is obstructed.

[0299] In one form of the present technology, the positioning and stabilization structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam material inner layer, and a fabric outer layer. In one form, the foam material is porous such that moisture (e.g., sweat) can pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0300] In a particular form of the present technology, the positioning and stabilization structure 3300 includes a strap that is stretchable (e.g., stretchable with elasticity). For example, the strap can be configured to be taut when in use and direct a force to bring the seal-forming structure into close contact with a part of the patient's face. In one embodiment, the strap can be configured as a tie.

[0301] In one form of the present technology, the positioning and stabilization structure includes a first tie, and the first tie is constructed and arranged such that at least a part of its lower edge moves upward and passes over to reach the upper ear base point of the patient's head during use, covering a part of the parietal bone without covering the occipital bone.

[0302] In one form of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a second tie. The second tie is constructed and arranged such that at least a part of its upper edge passes below the lower ear base point on the lower side of the patient's head during use and covers the occipital bone of the patient's head or is placed below the occipital bone of the patient's head.

[0303] In one form of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a third tie that is constructed and arranged to interconnect the first tie and the second tie so as to reduce the tendency of the first tie and the second tie to move away from each other in a separation direction.

[0304] 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.

[0305] 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 the interior.

[0306] Figures 89-95 illustrate a patient interface 3000 according to an example of the technology. The patient interface 3000 has a positioning and stabilization structure 3300 and a plenum chamber 3200 having a seal-forming structure 3100. In this example, the positioning and stabilization structure 3300 includes a frame 3350 and a plurality of headgear straps connected to the frame 3350.

[0307] The plenum chamber 3200 of the patient interface 3000 is connected to the frame 3350. The plenum chamber 3200 of the exemplary patient interface 3000 shown in Figures 89-95 is the plenum chamber 3200 shown in Figures 7-14, but the positioning and stabilization structure 3300 may be used with other plenum chambers 3200 in other examples of the technology. The plenum chamber 3200 may be connected to the frame 3350 via a snap-fit connection. In one example, the plenum chamber 3200 may be connected to the frame 3350 in the manner described with reference to Figures 87-88. In other examples, the plenum chamber 3200 may form a different type of removable connection to the frame 3350, such as a snap-fit, a removable press-fit, or others, or may be permanently connected to the frame 3350.

[0308] The positioning and stabilization structure 3300 may include a plurality of straps or strap portions. These straps or strap portions connect to the frame 3350 and pass around the patient's head to support the plenum chamber 3200 in a sealed position against the patient's face. It is understood that a single "strap" may be formed by a plurality of lengths of material (s) joined at the ends after being separately cut or formed to produce a longer length, or alternatively, a single "strap" may be a single length of material (s).

[0309] In the example shown in FIGS. 89 - 95, the positioning and stabilization structure 3300 includes a pair of upper straps 3310. Each upper strap 3310 is configured to pass between each of the patient's eyes and ears. Further, the positioning and stabilization structure 3300 includes a pair of lower straps 3320 configured to be disposed below the patient's cheekbones on both cheeks of the patient. In this example, the plenum chamber 3200 is held in place via a four - point connection to a headgear strap via the frame 3350.

[0310] Figures 103 - 108 show the frame 3350 in isolation. The frame 3350 includes a frame inlet connection port 3354. The frame inlet connection port 3354 can be configured to connect to a source of pressurized breathable gas (e.g., air). For example, in one example such as the patient interface shown in FIGS. 89 - 95, the frame inlet connection port 3354 can be configured to enable connection to a swivel elbow assembly 3610 that provides a connection port 3600 for connection to the air circuit 4170. In this example, the frame inlet connection port 3354 includes a connection rim 3355. The connection rim 3355 can include a flange that extends radially outward. The swivel elbow assembly 3610 can form a releasable snap fit with the connection rim 3355, thereby creating a fluid connection between the swivel elbow assembly and the frame 3350. As shown in FIGS. 87 - 88 and 90A, the opposite side of the frame inlet connection port 3354 is configured to provide a fluid connection to the plenum chamber. Thus, the frame 3350 enables a fluid connection between the swivel elbow assembly 3610 and the interior of the plenum chamber 3200.

[0311] The frame 3350 also includes a pair of opposing upper strap connection points 3315 that are the connection points for the upper straps 3310. In this example, each upper strap connection point 3315 includes an aperture formed in the frame 3350. Each upper strap 3310 can pass through the aperture, loop back on itself, and then be secured to itself to connect to each upper strap connection point 3315. Each upper strap 3310 can be secured to itself via hook and loop material configured to releasably couple when contacted. In another example, each upper strap 3310 can pass through each aperture, loop back on itself, and then be secured to itself by a band, clip, etc. In yet another example, the upper strap 3310 can be connected to the frame via a side release buckle connection.

[0312] Frame 3350 also includes a pair of opposing lower strap attachment points 3325 that are the attachment destinations of the lower straps 3320. In this example, each lower strap attachment point 3325 includes a magnet. Each lower strap 3320 includes a lower strap clip 3326 that includes a magnet or material. This magnet or material is attached to the magnet at the lower strap attachment point 3325. In this example, each lower strap clip 3326 includes an aperture. Through this aperture, after passing the end of each lower strap 3320, it can be looped back and fixed to itself (for example, by hook and loop material, a band, a clip, etc.). In another example, the lower strap 3320 is connected to the frame 3350 via a side release buckle connection and can be connected to a hook or any other suitable connection.

[0313] In one example, the frame 3350 and the upper strap attachment points 3315 are structured and arranged to direct the force / tension provided from the upper strap 3310 to a partially upward and partially rearward force vector that is applied to the plenum chamber 3200. Specifically, due to this partially upward and partially rearward force vector, the nose portion 3230 of the seal forming structure 3100 is brought into sealing contact with the peripheral portion under the patient's nose and the patient's upper lip.

[0314] Each of the upper straps 3310 can be selectively adjustable. For example, to change the effective length of each upper strap 3310, the component of the upper strap 3310 that loops back to itself after passing through the aperture at each upper strap attachment point 3315 can be changed. Increasing the component of the upper strap 3310 passing through the aperture effectively reduces the length of the upper strap 3310, thereby enabling the change of the force vector and the adjustment of the fit of the patient interface 3000.

[0315] In one example, the frame 3350 and the lower strap attachment point 3325 are structured and arranged to direct the force / tension provided from the lower strap 3320 into a partially rearward and partially downward force vector that is applied to the plenum chamber 3200. Specifically, due to the partially rearward and partially downward force vector, the oral site 3260 is sealingly contacted with the patient's face around the perimeter of the patient's mouth. The partially downward force applied from the lower strap 3320 to the frame 3350 can balance the partially upward force applied from the upper strap 3310 and any downward-directed force that may be applied from the patient's nose to the seal-forming structure 3100.

[0316] The lower strap 3320 can be selectively adjustable. For example, changing the effective length of each lower strap 3320 can be done by changing the component of each lower strap 3310 that loops back on itself after passing each lower strap 3310 through the aperture in each lower strap clip 3326. Increasing the component of each lower strap 3320 that passes through the aperture effectively reduces the length of the lower strap 3320, thereby enabling a change in the force vector and adjustment of the fit of the patient interface 3000.

[0317] The positioning and stabilization structure 3300 may also include one or more of a top crown strap 3330, a pair of lateral crown straps 3332, and a neck strap 3334. In the examples shown in FIGS. 89-95, the upper strap 3310 and the lower strap 3320 are connected to the ends of the top crown strap 3330. The top crown strap 3330 is configured to pass around the patient's head and be disposed against surfaces facing upward and rearward. The top crown strap 3330 may be configured to be disposed on the parietal bone of the patient's skull. Each end of the top crown strap 3330 is also connected to each of the upper straps 3310 and each of the pair of lateral crown straps 3332. Each of the lateral crown straps 3332 is connected between the upper strap 3310 and the lower strap 3320 at each side of the patient's head. The lower ends of the lateral crown straps 3332 are interconnected by the neck strap 3334. The neck strap 3334 may be configured to pass through the sagittal plane and be disposed against a surface facing downward and / or rearward of the patient's head or be disposed behind the patient's neck. The neck strap 3334 may be disposed above or below the occipital bone of the patient's skull.

[0318] The length of the top crown strap 3330 can be selectively adjusted. In the examples shown in FIGS. 89-95, the top crown strap 3330 is formed by two strap portions connected by a link having a pair of apertures. These two strap portions forming the top crown strap 3330 can loop back after passing through each of the apertures and secure to themselves via, for example, hook and loop material, additional clips, bands, and / or others. The amount of each upper strap portion sent through the link can be varied for adjustment of the length of the top crown strap 3330 and thus the fit of the positioning and stabilization structure 3300.

[0319] After adjustment of all headgear straps and achievement of the desired fit of the patient interface 3000, the lower strap 3320 can be quickly disengaged from the lower strap connection point 3325 on the frame 3350 by the magnetic clip connection provided by the lower strap clip 3326, thereby enabling removal of the patient interface 3000 from the patient without strap adjustment. Similarly, when the patient re-wears the patient interface, the lower strap clip 3326 can be quickly disengaged at the lower strap connection point 3325 to fit the patient interface 3000 without the need for strap adjustment. Further advantages and features of the positioning and stabilization structure including the magnetic clip are described in WO2014 / 110622. This document is hereby incorporated by reference in its entirety.

[0320] 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 one form of the positioning and stabilization structure 3300 that is suitable for a large-sized head rather than a small-sized head and another form that is suitable for a small-sized head rather than a large-sized head.

[0321] Figures 184 and 185 show a patient interface 3000 including a plenum chamber 3200 shown in FIGS. 134-141. In this example, the patient interface 3000 also includes a positioning and stabilization structure 3300 for holding the plenum chamber 3200 in a sealed position on the patient's face during use. In this example, the positioning and stabilization structure 3300 includes a pair of headgear tubes 3340. The pair of headgear tubes 3340 are interconnected at their upper ends and are each configured to be disposed on the upper and lateral surfaces of the patient's head during use. The headgear tubes 3340 are each configured to be disposed between the patient's eye and ear during use. The lower end of each headgear tube 3340 is configured to fluidly connect to the plenum chamber 3300. In this example, the lower end of each headgear tube 3340 connects to a headgear tube connector 3344 configured to connect to the shell 3210 of the plenum chamber 3200. The positioning and stabilization structure 3300 includes a conduit headgear inlet 3390 at the junction of the two headgear tubes 3340. The conduit headgear inlet 3390 is configured to receive a pressurized gas flow, for example, via an elbow including a connection port 3600, and to flow this gas flow into the hollow interior of the headgear tubes 3340. By these headgear tubes 3340, a pressurized gas flow is supplied to the plenum chamber 3200.

[0322] The positioning and stabilization structure 3300 may include one or more straps in addition to these headgear tubes 3340. In this example, the positioning and stabilization structure 3300 includes a pair of upper straps 3310 and a pair of lower straps 3320. The rear ends of the upper straps 3310 and the lower straps 3320 are joined to each other. The joint between the upper strap 3310 and the lower strap 3320 is configured to be disposed on the rear surface of the patient's head, enabling the upper strap 3310 and the lower strap 3320 to be anchored. The front end of the upper strap 3310 is connected to the headgear tube 3340. In this example, each headgear tube 3340 includes a tab 3342 having an opening. Through this opening, after each upper strap 3310 is sent through and looped back and fixed to itself, the upper headgear strap 3310 can be fixed to the headgear tube 3340. The positioning and stabilization structure 3300 also includes lower strap clips 3326 provided at the front end of each of the lower straps 3320. Each of the lower strap clips 3326 is configured to be connected to a lower connection point 3325 on the plenum chamber 3200. In this example, the lower strap clip 3326 is magnetically fixed to the lower connection point 3325. In some examples, a mechanical engagement is also provided between the lower strap clip 3326 and the lower connection point 3325.

[0323] The headgear tube connector 3344 can be configured to allow a patient to breathe ambient air when there is no pressure in the plenum chamber 3200. Each headgear tube connector 3344 may include an anti-asphyxiation valve (AAV). The AAV in each headgear tube connector 3344 can be configured to open when there is no pressure in the plenum chamber 3200 to allow air flow between the interior and the surroundings of the plenum chamber 3200. Each AAV can be biased into a configuration that blocks air flow from the interior of the plenum chamber 3200 into each headgear tube 3340 and allows air exchange between the plenum chamber 3200 and the surroundings. When the headgear tube 3340 is pressurized, the AAV in each headgear tube connector 3344 can prevent air exchange between the interior and the surroundings of the plenum chamber 3200 and allow air flow from each headgear tube 3340 into the plenum chamber 3204 for the patient's breathing.

[0324] 5.3.3 Ventilation section

[0325] In one form, the patient interface 3000 includes a ventilation section 3400 configured and arranged to allow expulsion of exhaled gas (e.g., carbon dioxide).

[0326] In a particular form, the ventilation section 3400 is configured to allow a continuous ventilation flow from the interior of the plenum chamber 3200 to the atmosphere when the pressure in the plenum chamber is positive relative to the atmosphere. The ventilation section 3400 is configured such that, during use, while maintaining the therapeutic pressure in the plenum chamber, the magnitude of the ventilation flow is large enough to reduce rebreathing by the patient of exhaled CO 2 to a sufficient extent.

[0327] One form of the ventilation section 3400 according to the present technology includes a plurality of holes (e.g., about 20 to about 80 holes or about 40 to about 60 holes or about 45 to about 55 holes).

[0328] The ventilation part 3400 can be arranged inside the plenum chamber 3200. Alternatively, the ventilation part 3400 is arranged inside a disconnection structure (for example, a swivel).

[0329] In the examples shown in FIGS. 89 to 95, the patient interface 3000 includes the ventilation part 3400. In this example, the ventilation part 3400 includes passages inside the frame 3350 and the swivel elbow assembly 3610. Through these passages, air can flow from the inside to the outside of the plenum chamber 3200. As shown in FIGS. 91, 95 and 103 to 105, the frame 3350 includes four holes that form part of the ventilation part 3400 around the periphery of the frame inlet connection port 3354. In other examples, any number of ventilation holes (for example, a single ventilation hole) can be provided in the frame 3350. As shown in FIG. 90, after air flows into the swivel elbow assembly 3610, it can flow to the outside through the external holes of the swivel elbow assembly 3610 that form part of the ventilation part 3400. The swivel elbow assembly 3610 can be substantially the same as that described in International Publication No. WO2017 / 049357A1. The entire content of this document is incorporated herein by reference.

[0330] The plenum chamber 3200 shown in FIGS. 126 to 157 includes a ventilation portion 3400. In this example, the ventilation portion 3400 includes a plurality of holes. In these examples, the ventilation portion 3400 is provided on the shell 3210. In this example, the holes of the ventilation portion 3400 are formed in the shell 3210. In other examples of the present technology, the patient interface 3000 may include a ventilation module permanently or removably connected to the plenum chamber 3200. In some examples of the present technology, the patient interface 3000 includes a ventilation diffuser configured to diffuse air passing through the ventilation portion 3400. In the plenum chamber 3400 shown in FIGS. 126 to 157, the ventilation portion 3400 is provided at the center. In the case of the ventilation portion 3400 provided at the center with respect to the plenum chamber 3200, it is advantageous because the possibility of being blocked when lying on the side is reduced. Further, in these examples, the ventilation portion 3400 is provided at a lower position of the shell 3210. Due to the lower position on the shell 3210, the ventilation portion 3400 is substantially aligned with the patient's mouth. Since most of the exhaled air from the patient comes from the patient's mouth, the ventilation portion 3400 disposed on the opposite side of the patient's mouth may enable good flushing of the gas. Further, since the inlet port 3240 of the plenum chamber 3200 is provided at an upper position of the plenum chamber 3200, the biasing air flow received from the inlet port 3240 can flow through a large volume (for example, from the upper position to the lower position), so that efficient gas flushing can be achieved, and the possibility of the biasing flow bypassing the stagnant air pocket portion can be reduced.

[0331] 5.3.4 Disengagement Structure(s)

[0332] In one form, the patient interface 3000 includes at least one disengagement structure (e.g., a swivel or ball and socket).

[0333] 5.3.5 Connection Port

[0334] The connection port 3600 enables connection to the air circuit 4170.

[0335] 5.3.6 Frontal support part

[0336] In one form, the patient interface 3000 includes a frontal support part 3700 as shown in FIG. 3A. For example, in other examples as shown in FIGS. 7 to 125, the patient interface 3000 may exclude the frontal support site. Further, the patient interface 3000 may be configured not to contact the patient's forehead at all.

[0337] 5.3.7 Anti-asphyxia valve

[0338] In one form, the patient interface 3000 includes an anti-asphyxia valve.

[0339] As described above, the patient interface 3000 may include one or more headgear tubes 3340 connected to the plenum chamber 3200 via a headgear tube connector 3344 including an anti-asphyxia valve. Alternatively or additionally, the patient interface 3000 may include a swivel elbow configured to connect to a supply conduit. The swivel elbow includes an anti-asphyxia valve. In other examples, the anti-asphyxia valve may be incorporated into the plenum chamber 3200, for example, by being provided on the shell 3210 of the plenum chamber 3200.

[0340] 5.3.8 Ports

[0341] In one form of the present technology, the patient interface 3000 includes one or more ports that enable access to the amount 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 of the gas (e.g., pressure) within the plenum chamber 3200.

[0342] 5.4 RPT device

[0343] 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 (e.g., any of the methods described herein, in whole or in part). The RPT device 4000 can 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 in any one of the paragraphs herein, for example.

[0344] In one form, the RPT device 4000 is constructed and arranged to be able to deliver an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH 2 O or at least 10 cmH 2 O or at least 20 cmH 2 O. The RPT device algorithm

[0345] The RPT device can have an external housing 4010. The external housing 4010 is formed by two parts, an upper part 4012 and a lower part 4014. Further, the external housing 4010 can include one or more panels 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 can include a handle 4018.

[0346] The pneumatic path of the pneumatic RPT device 4000 can include one or more air circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) as well as one or more transducers 4270 (e.g., a pressure sensor and a flow sensor).

[0347] As described above, in some forms of the present technology, the central control device may be configured to embody one or more algorithms expressed as a computer program recorded in a non-temporary computer-readable recording medium (e.g., memory). These algorithms are generally grouped into groups called modules.

[0348] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller, a treatment device controller, a pressure generator 4140, one or more protection circuits, a memory, a converter 4270, a data communication interface, and one or more output devices 4290. The electrical components 4200 can be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 can include more than one PCBA 4202.

[0349] The RPT device according to one form of the present technology can include an air filter 4110 or a plurality of air filters 4110.

[0350] In one form, the outlet air filter 4114 (e.g., antibacterial factor) is disposed between the outlet of the air pressure block 4020 and the patient interface 3000.

[0351] The RPT device according to one form of the present technology can include a muffler 4120 or a plurality of mufflers 4120.

[0352] In one form of the present technology, the anti-spillback valve 4160 can be disposed between the humidifier 5000 and the air pressure block 4020. The anti-spillback valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 (e.g., to the blower motor 4144).

[0353] 5.5 Air Circuit

[0354] An air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged such that, in use, an air flow moves between two components (e.g., an RPT device 4000 and a patient interface 3000).

[0355] 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 legs of the circuit for inhalation and exhalation. In other cases, a single leg is used.

[0356] 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.

[0357] 5.5.1 Oxygen Delivery

[0358] In one form of the present technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic path (e.g., upstream of the pneumatic block 4020), the air circuit 4170, and / or the patient interface 3000.

[0359] 5.6 Humidifier

[0360] 5.6.1 Overview of the Humidifier

[0361] In one form of the present 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., as shown in FIG. 5A). 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 the patient airway.

[0362] 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 forms, such as shown in FIGS. 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.

[0363] As shown in FIG. 5C, the humidifier controller 5250 may include one or more controllers (e.g., a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240).

[0364] 5.6.2 Humidifier Components

[0365] 5.6.2.1 Water Reservoir

[0366] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a certain 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 the 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 forms, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building water supply system).

[0367] 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 form, the water reservoir 5110 may be configured to facilitate the movement of the air flow in a serpentine path through the reservoir 5110 while the air flow contacts a certain amount of water in the reservoir 5110.

[0368] According to one form, the reservoir 5110 may be removable from the humidifier 5000 in the lateral direction as shown, for example, in FIGS. 5A and 5B.

[0369] The reservoir 5110 may also be configured to inhibit the release of liquid from the reservoir 5110 when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any apertures and / or between its sub-components). Since the air flow to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent air pressure loss through leakage and / or flow impedance.

[0370] 5.6.2.2 Conductive sites

[0371] According to one arrangement, the reservoir 5110 includes a conductive site 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 site 5120 can be arranged as a plate, although other shapes may also be suitable. All or part of the conductive site 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.

[0372] 5.6.2.3 Humidifier Reservoir Dock

[0373] In one form, the humidifier 5000 can include a humidifier reservoir dock 5130 configured to receive the humidifier reservoir 5110 (as shown in FIG. 5B). 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).

[0374] 5.6.2.4 Water Level Indicator

[0375] The humidifier reservoir 5110 can include a water level indicator 5150 as shown in FIGS. 5A - 5B. In some forms, the water level indicator 5150 can provide one or more indications to a user such as the 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 can include notification of a maximum predetermined amount of water, any portion thereof (e.g., 25%, 50%, or 75% or an amount (e.g., 200 ml, 300 ml, or 400 ml)).

[0376] 5.6.2.5 Humidifier Converter(s)

[0377] The humidifier 5000 may include one or more humidifier converters (sensors) 5210 instead of or in addition to the above-described converter 4270. The humidifier converter 5210 may include one or more of a pneumatic sensor 5212, an air flow converter 5214, a temperature sensor 5216, or a humidity sensor 5218 as shown in FIG. 5C. The humidifier converter 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., a central controller and / or a humidifier controller 5250). In some forms, the humidifier converter may be disposed outside the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signal to the controller.

[0378] 5.7 Respiratory waveform

[0379] FIG. 6A shows a typical respiratory waveform of a model of a person during sleep. The horizontal axis is time and the vertical axis is respiratory flow. Since the parameter values can vary, a typical respiration may have the following approximate values: tidal volume, Vt, 0.5 L, inspiratory time, Ti, 1.6 s, peak inspiratory flow, Qpeak, 0.4 L / s, expiratory time, Te, 2.4 s, peak expiratory flow, Qpeak, -0.5 L / s. The total duration of respiration Ttot is about 4 seconds. A person typically breathes about 15 times per minute (BPM), and the ventilation Vent is about 7.5 L / min. The ratio of a typical duty cycle, Ti to Ttot, is about 40%.

[0380] 5.8 Respiratory pressure therapy mode

[0381] Depending on the values of the parameters A and P in the treatment pressure equation (error! Reference source not found) used by the treatment parameter determination algorithm in one form of the present technology, various respiratory pressure therapy modes may be performed by the RPT device 4000. 0

[0382] 5.9 Glossary

[0383] For the purposes of the disclosure of this technology, in certain forms of this technology, one or more of the following definitions may apply. In other forms of this technology, other definitions may also apply.

[0384] 5.9.1 General

[0385] Air: In certain forms of this technology, air may mean the atmosphere, and in other forms of this technology, air may mean a combination of other breathable gases (e.g., an atmosphere rich in oxygen).

[0386] Atmosphere: In certain forms of this 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.

[0387] For example, the atmosphere for a humidifier Humidity may be the humidity of the air that directly surrounds the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such atmospheric humidity may be different from the humidity outside the room where the patient is sleeping.

[0388] In another example, the atmospheric pressure may be the pressure directly around or outside the body.

[0389] In certain forms, atmospheric (e.g., acoustic) noise can be considered the background noise level in the room where the patient is located, for example, other than the noise generated from the RPT device or from the mask or patient interface. Atmospheric noise can be generated from sources outside the room.

[0390] Automated positive airway pressure (APAP) therapy: A CPAP therapy that can automatically adjust the treatment pressure, for example, between a minimum and a maximum limit during the breathing cycle, depending on the presence or absence of a notification of the occurrence of SDB.

[0391] Continuous Positive Airway Pressure (CPAP) therapy: A respiratory pressure therapy in which the therapeutic pressure is substantially constant throughout the patient's respiratory 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 respiratory cycles of the patient (e.g., increases in response to detection of signs of partial upper airway obstruction and decreases in the absence of notification of partial upper airway obstruction).

[0392] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to the instantaneous amount. In some cases, when referring to flow rate, it refers to a scalar quantity (i.e., a quantity having only magnitude). In other cases, when referring to flow rate, it refers to a vector quantity (i.e., a quantity having both magnitude and direction). Flow rate may be assigned the symbol Q. The "flow rate" may be abbreviated as "flow" in some cases.

[0393] 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 (H 2 O) vapor to an air stream to improve the patient's medical respiratory condition.

[0394] Leakage: The term "leakage" is taken as an unintended air flow. In one embodiment, leakage can occur due to an incomplete seal between the mask and the patient's face. In another embodiment, leakage can occur at a swivel elbow to the surroundings.

[0395] Noise conduction (acoustic): In this document, conduction noise refers to noise conveyed to the patient by 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.

[0396] Noise emission (acoustic): In this document, emitted noise refers to noise conveyed to the patient by the surrounding air. In one form, emitted noise can be quantified by measuring the acoustic power / pressure level of the object according to ISO3744.

[0397] Noise ventilation (acoustic): In this document, ventilation noise refers to noise generated by an air flow through any ventilation (e.g., ventilation holes in a patient interface).

[0398] Patient: A person with or without a respiratory disease.

[0399] Pressure: Force per unit area. Pressure can be expressed in various units (e.g., cmH 2 O, g-f / cm 2 , and hectopascal). 1 cmH 2 O is equal to 1 g-f / cm 2 , and is approximately 0.98 hectopascal. In this specification, unless otherwise specified, pressure is given in the unit of cmH 2 O.

[0400] The pressure in the patient interface is given the symbol Pm, and the therapeutic pressure representing the target value to be achieved by the mask pressure Pm at the current time is given the symbol Pt.

[0401] Respiratory pressure therapy (RPT): Addition of an air supply to the airway inlet at a therapeutic pressure that is typically positive pressure with respect to the atmosphere.

[0402] Ventilator: A mechanical device that provides pressure assistance when a patient performs part or all of the breathing motion.

[0403] 5.9.1.1 Materials

[0404] Silicone or silicone elastomer: A synthetic rubber. In this specification, when silicone is mentioned, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). As one form of commercially available LSR, Dow There is SILASTIC manufactured by Corning (included in the product groups sold under this registered trademark). Another LSR manufacturer is Wacker. Unless otherwise specified, the Shore A (or Type A) indentation hardness of the LSR in the exemplary form, when measured by ASTM D2240, is about 35 to about 45.

[0405] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0406] 5.9.1.2 Mechanical Properties

[0407] Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0408] Elastic: Substantially all energy is released during unloading. For example, it includes certain silicones and thermoplastic elastomers.

[0409] Hardness: The ability of a material to resist deformation by itself (e.g., as described by the Young's modulus or an indentation hardness scale measured on a standardized sample size).

[0410] · "Soft" materials can include silicones or thermoplastic elastomers (TPE), and can be easily deformed, for example, under finger pressure.

[0411] · "Hard" materials can include polycarbonate, polypropylene, steel, or aluminum, and cannot be easily deformed, for example, under finger pressure.

[0412] 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 can provide different resistances in different directions.

[0413] Flabby structure or component: A structure or component that changes (e.g., bends) its shape within a relatively short period (e.g., 1 second) when supporting its own weight.

[0414] 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 the patient airway inlet at a pressure load of, for example, approximately 20 - 30 cmH 2 O.

[0415] As an 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 flabby in a first direction and rigid in a second direction.

[0416] 5.9.2 Respiratory cycle

[0417] 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 allowed due to some airway obstruction. Central apnea refers to the state where apnea is detected due to a decrease or absence of respiratory effort despite the airway being open. Mixed apnea refers to the state where a decrease or absence of respiratory effort occurs simultaneously with airway obstruction.

[0418] Respiratory rate: The patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0419] Duty cycle: The ratio of the inspiratory time Ti to the total respiratory time Ttot.

[0420] Effort (respiratory): Respiratory effort is said to refer to the movement performed by the spontaneous breathing of a person trying to breathe.

[0421] Expiratory portion of the respiratory cycle: The period from the start of the expiratory flow to the start of the inspiratory flow.

[0422] Flow limitation: Flow limitation is construed as a situation in a patient's respiration where an increase in the patient's effort does not cause a corresponding increase in flow. If flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0423] Hypopnea: According to some definitions, hypopnea means a decrease in flow rather than an interruption of flow. In one form, hypopnea is said to have occurred if a decrease in flow below a threshold velocity persists over a period of time. If 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 be considered hypopnea:

[0424] (i) A 30% decrease in patient respiration for at least 10 seconds + associated 4% desaturation, or,

[0425] (ii) A decrease (less than 50%) in patient respiration that persists for at least 10 seconds and is associated with at least 3% desaturation or arousal occurs.

[0426] Hyperpnea: An increase in flow to a level higher than the normal flow rate.

[0427] 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.

[0428] Patency (airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency is an opening. Quantification of airway patency can be done, for example, with a value (1) indicating patency and a value (0) indicating closure (obstruction).

[0429] Positive end-expiratory pressure (PEEP): A pressure above the atmosphere in the lungs that exists at the end of exhalation.

[0430] Peak flow (Qpeak): The maximum flow value in the inspiratory portion of the respiratory flow waveform.

[0431] Respiratory airflow, air flow, patient air flow, respiratory 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 airflow", which is the actual respiratory flow of the patient, usually expressed in liters per minute.

[0432] Tidal volume (Vt): The amount of air inhaled or exhaled during normal breathing without extra effort. In principle, the inspiratory volume V i (the amount of inhaled air) is equal to the expiratory volume V e (the amount of exhaled air), so a single tidal volume V t can be defined as equal to either amount. In practice, the tidal volume V t is estimated as some combination (e.g., the average of the inspiratory volume V i and the expiratory volume V e ).

[0433] Inspiratory time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0434] Expiratory time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0435] 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.

[0436] 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 tend to cluster over a given time scale.

[0437] Upper airway obstruction (UAO): Includes both partial upper airway obstruction and total upper airway obstruction. It may be associated with a state of flow limitation in which flow may increase slightly or decrease with an increase in the pressure difference across the upper airway (Starling resistor behavior).

[0438] Ventilation (Vent): Measurement of the rate of gas exchange performed by a patient's respiratory system. 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.

[0439] 5.9.3 Anatomical Structures

[0440] 5.9.3.1 Facial Anatomical Structures

[0441] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0442] Alare: The outermost point on the alar.

[0443] Alar curvature (or alar summit) point: The most posterior point on the curvilinear reference line of each ala, seen at the fold formed by the junction of the ala and the cheek.

[0444] Pinna: The entire visible part of the ear.

[0445] (Nasal) Skeleton: The nasal skeleton includes the nasal bones, the frontal processes of the maxillae, and the nasal part of the frontal bone.

[0446] (Nasal) Cartilage Skeleton: The nasal cartilage skeleton includes the septal cartilage, the lateral cartilages, the major cartilages, and the minor cartilages.

[0447] Columella: A skin flap that separates the nostrils and extends from the tip of the nose to the upper lip.

[0448] 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.

[0449] Frankfurt horizontal plane: A line extending from the lowest point of the orbital margin to the auricular point. The auricular point is the deepest point from the upper notch to the tragus of the auricle.

[0450] Glabella: A point located in the soft tissue and most prominent on the mid-sagittal plane of the forehead.

[0451] 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.

[0452] Lower lip (labrale inferius):

[0453] Upper lip (labrale superius):

[0454] Major alar cartilage: A plate of cartilage located below the lateral nasal cartilage. It curves around the front part of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar minor cartilages.

[0455] Nostril (nasal cavity): Generally an oval wing-shaped cavity that forms the entrance to the nasal cavity. The singular form of nostril (nares) is nostril (naris) (nasal cavity). These nostrils are separated by the nasal septum.

[0456] 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 and separates the cheek from the upper lip.

[0457] Nasolabial angle: The angle between the nasal columella and the upper lip, which intersects with the subnasale point.

[0458] Lower ear attachment point: The lowest point of attachment of the auricle to the facial skin.

[0459] Upper ear attachment point: The highest point of attachment of the auricle to the facial skin.

[0460] Nasal tip: 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.

[0461] Philtrum: A midline groove extending from the lower border of the nasal septum to the upper lip in the upper lip region.

[0462] Pogonion: The most anterior midpoint on the jaw, located on the soft tissue.

[0463] Nasal (ridge): The nasal ridge is a midline elevation of the nose that extends from the sellion to the nasal tip.

[0464] Sagittal plane: A vertical plane that extends from the front (anterior) to the back (posterior). The median sagittal plane is the sagittal plane that divides into a right half and a left half.

[0465] Sellion: The most concave point on the soft tissue, located on the region of the fronto-nasal suture.

[0466] Septal cartilage (nose): The septal cartilage is part of the septum and divides the front part of the nasal cavity.

[0467] 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.

[0468] Subnasale: Located on the soft tissue, the point where the columella joins the upper lip in the median sagittal plane.

[0469] Supramenton: The most concave point in the midline of the lower lip between the midpoint of the lower lip and the soft tissue pogonion.

[0470] 5.9.3.2 Anatomical Structure of the Skull

[0471] Frontal bone: The frontal bone includes the frontal squama, which is a large vertical part corresponding to the region known as the forehead.

[0472] Mandible: The mandible forms the lower jaw. The gonial eminence is a bony prominence of the jaw that forms the jaw.

[0473] Maxilla: The maxilla forms the upper jaw and is located below the upper jaw and below the eye socket. The frontal process of the maxilla protrudes upward by the side of the nose and forms the part of its outer boundary.

[0474] Nasal bone: The nasal bones are two small rectangular bones, and their size and shape vary 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.

[0475] 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.

[0476] Occipital bone: The occipital bone is located on the back and lower part of the skull. The occipital bone contains the foramen magnum, which is an elliptical hole. Through this hole, the cranial cavity is connected to the spinal canal. The curved plate on the posterior side of the foramen magnum is the occipital squama.

[0477] Eye socket: A bony cavity in the skull that contains the eyeball.

[0478] Parietal bone: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0479] Temporal bone: The temporal bone is located on the base and sides of the skull and supports the part of the face known as the temple.

[0480] Zygomatic bone: The two zygomatic bones contained in the face are located in the upper and outer parts of the face and form the cheek prominences.

[0481] 5.9.3.3 Anatomical Structure of the Respiratory System

[0482] Diaphragm: A sheet-like 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.

[0483] Larynx: The larynx or voice box that houses the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0484] 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.

[0485] 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 conchae or turbinate bones on the sides of the nasal cavity. There is a nose at the front of the nasal cavity, and it connects to the nasopharynx through the posterior nares at the back.

[0486] Pharynx: The part of the throat located directly below (inferior) the nasal cavity and above the esophagus and larynx. The pharynx has conventionally 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).

[0487] 5.9.4 Patient Interface

[0488] Anti-asphyxia valve (AAV): A component or sub-assembly of the mask system that reduces the risk of rebreathing excessive CO 2 by the patient through an opening to the atmosphere in a fail-safe manner.

[0489] Elbow: An 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 with respect 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.

[0490] 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-bearing structure in the mask. However, some forms of the mask frame can be airtight.

[0491] 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 set of one or more struts, ties, and supplementary stiffeners configured to position and hold a patient interface at a predetermined position on the patient's face for the delivery of respiratory therapy. Some ties are formed of a soft, flexible elastic material (e.g., a laminated composite of a foam material and a fabric).

[0492] Membrane: The membrane is taken to typically mean a thin element, preferably substantially resistant to bending and resistant to stretching and contracting.

[0493] Pleural Chamber: The mask pleural chamber is taken to mean a part of the patient interface having a wall that at least partially encloses the volume of space, and the air in the volume is pressurized to exceed atmospheric pressure during use. The shell can form part of the wall of the mask pleural chamber.

[0494] Seal: When used as a noun (the "seal"), it can refer to the structure, and when used as a verb (to "seal"), it can refer to its effect. The two elements can be constructed and / or arranged such that they "seal" or obtain a "sealing" effect between them without requiring separate "seal" elements themselves.

[0495] Shell: The shell is taken to mean a relatively thin-walled, curved structure having bending, tensile, and compressive rigidity. For example, the curved structure 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.

[0496] Reinforcing member: The reinforcing member is taken to mean a structural component designed to increase the stiffness or softness of another component in at least one direction.

[0497] Strut: The strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0498] Swiivel (noun): A subassembly of components configured to rotate preferably independently and preferably under low torque about a common axis. In one form, the swivel can be configured to rotate at an angle of at least 360 degrees. In another form, the swivel can be configured to rotate at an angle less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably includes a pair of cylindrical conduits in combination. In use, there is little leakage of air flow from the swivel.

[0499] Tie (noun): A structure designed to resist tension.

[0500] Ventilation: (noun): A structure that allows air flow to the ambient air inside a mask or conduit, enabling clinically effective flushing of the exhaled gas. For example, in clinically effective flushing, a flow rate of about 10 liters / minute to about 100 liters / minute can be used depending on the mask design and treatment pressure.

[0501] 5.9.5 Shape of the structure

[0502] The product according to the present technology may include one or more three-dimensional mechanical structures (for example, a mask cushion or an impeller). The three-dimensional structure may be limited by a two-dimensional surface. These surfaces may be distinguished using labels for describing the direction, position, function, or some other property of the associated surface. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another embodiment, the seal-forming structure may include a face contact (for example, outer) surface and a separate non-face contact (for example, lower or inner) surface. In another embodiment, the structure may include a first surface and a second surface.

[0503] To facilitate the description of the shape of the three-dimensional structure and the surface, first consider the cross-section at a point p through the surface of the structure. See FIGS. 3B to 3F. FIGS. 3B to 3F show an example of a cross-section at a 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.

[0504] 5.9.5.1 Curvature in one dimension

[0505] The curvature of the planar curve at p can be described as having a sign (for example, positive, negative) and a magnitude (for example, 1 / radius of the circle tangent to the curve at p).

[0506] Positive curvature: When the curve at p bends towards the outward normal, the curvature at that point is taken to have a positive value (if this imaginary little person walks away from point p, they need to walk uphill). See FIGS. 3B (relatively large positive curvature compared to FIG. 3C) and 3C (relatively small positive curvature compared to FIG. 3B). Such curves are often called concave.

[0507] Zero curvature: When the curve at p is a straight line, the curvature is taken to be zero (if this imaginary little person walks away from point p, they can walk on a horizontal plane that is neither uphill nor downhill). See FIG. 3D.

[0508] Negative curvature: When the curve at p bends in a direction away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if this imaginary little person walks away from point p, they need to walk downhill). See FIGS. 3E (relatively small negative curvature compared to FIG. 3F) and 3F (relatively large negative curvature compared to FIG. 3E). Such curves are often called convex.

[0509] 5.9.5.2 Curvature of a two - dimensional surface

[0510] The description of the shape at a given point on a two - dimensional surface according to this technique can include a plurality of vertical cross - sections. The plurality of cross - sections can cut the surface in a plane containing the outward normal (the "normal plane"), and each cross - section can 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 can have the same sign or different signs. Each curvature at that point has a magnitude (e.g., relatively small). The planar curves in FIGS. 3B - 3F can be examples of such a plurality of cross - sections at a specific point.

[0511] Principal curvature and direction: The directions of the normal planes at which the curvature of a 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 in FIG. 3F, FIGS. 3B and 3F are cross-sections in the principal directions. The principal curvature at p is the curvature in the principal direction.

[0512] Region of a surface: A set of connected points on a surface. This set of points within the region can have similar properties (e.g., curvature or sign).

[0513] Saddle region: A region where the principal curvatures have opposite signs (i.e., one positive and the other negative) at each point (depending on the direction in which an imaginary person walking uphill or downhill would face).

[0514] Dome region: A region where the principal curvatures have the same sign (both positive for a "concave dome" or both negative for a "convex dome") at each point.

[0515] Cylindrical region: A region where one principal curvature is zero (or zero within manufacturing tolerances, for example) and the other principal curvature is non-zero.

[0516] Plane region: A region of a surface where both principal curvatures are zero (or zero within manufacturing tolerances, for example).

[0517] Edge of a surface: The boundary or limit of a surface or region.

[0518] Path: In a particular form of the present technology, a "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 a particular form of the present technology, a "path" can be described as a route or course that includes, for example, a set of points on a surface. (The path of an imaginary person is where one walks on the surface and is similar to a garden path).

[0519] Path length: In certain forms of the present technology, "path length" is taken to refer to the distance from f(0) to f(1) along the surface (i.e., the distance along the path on the surface). There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length of a hypothetical person is the distance walked along the path on the surface).

[0520] Straight-line distance: The straight-line distance is the distance between two points on the surface, without considering the surface. On a planar region, there is a distance on the edge of the surface 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 be a path that has the same path length as the straight-line distance between two points. (For a hypothetical person, the straight-line distance corresponds to the "distance a crow flies").

[0521] 5.9.5.3 Space curve

[0522] Space curve: Unlike a planar curve, a space curve does not necessarily exist within any particular plane. A space curve can be closed. That is, it has no endpoints. A space curve can be considered a one-dimensional piece of three-dimensional space. A hypothetical 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 Figure 3Q). A typical human right ear contains a right-handed helix (see Figure 3R). Figure 3S shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or an impeller) 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.

[0523] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a person in mid-air is flying along a curve and falls from their vehicle at a specific point, the direction of the tangent vector is the direction in which the person should be moving.

[0524] Unit normal vector: When a person in mid-air 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.

[0525] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Fig. 3P) or, alternatively, the left-hand rule (Fig. 3O).

[0526] Contact plane: The plane containing the unit tangent vector and the unit principal normal vector. See Figs. 3O and 3P.

[0527] 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 contact plane of the curve. The torsion of a space curve lying in a plane is zero. When the deviation from the contact 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 contact 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.

[0528] Referring to the right - hand rule of FIG. 3P, a space curve that bends in the direction of the right - hand normal line can be regarded as having a positive twist in the right - hand direction (for example, a right - hand helix as shown in FIG. 3S). A space curve that faces away from the right - hand normal line direction can be regarded as having a negative twist of the right - hand (for example, a left - hand helix).

[0529] Similarly, referring to the left - hand rule (see FIG. 3O), a space curve that faces in the left - hand normal line direction can be regarded as having a positive twist of the left - hand (for example, a left - hand helix). Thus, the positive direction of the left - hand corresponds to the negative direction of the right - hand. See FIG. 3T.

[0530] 5.9.5.4 Holes

[0531] A surface can have one - dimensional holes (for example, holes bounded by a planar curve or a space curve). In the case of a thin - walled structure (for example, a membrane) that contains 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.

[0532] A structure can have two - dimensional holes (for example, holes bounded by a surface). For example, an inflatable tire has two - dimensional holes bounded by the inner surface of the tire. In another embodiment, a bladder with a cavity for air or gel can have two - dimensional holes. For example, refer to the cushion of FIG. 3L and the exemplary cross - sections of FIG. 3L in FIGS. 3M and 3N where the inner surface bounding the two - dimensional hole is shown. In yet another embodiment, a conduit can include one - dimensional holes (for example, at its inlet or its outlet) and can include two - dimensional holes bounded by the inner surface of the conduit. Also refer to the two - dimensional hole passing through the structure shown in FIG. 3K and bounded by the surface as shown.

[0533] 5.10 Other Considerations

[0534] Unless otherwise clearly apparent from the context and unless a range of values is provided, it is understood that each intervening value between the lower limit unit of 1 / 10, between the upper and lower limits of the range, and any other recited value or intervening value within the recited range is encompassed by the present technology. Even if the upper and lower limits of these intervening ranges independently included within the intervening range particularly exceed the limits in the recited range, they are still encompassed by the present technology. If the recited range includes one or both of these limits, ranges exceeding either or both of these recited limits are also encompassed by the present technology.

[0535] Furthermore, when values (singular or plural) are embodied as part of the present technology herein, unless otherwise specified, it is understood that such values can be approximated and used to any appropriate significant digits to the extent permitted or required by the actual technical implementation.

[0536] Unless otherwise noted, all technical and scientific terms used herein have the same meaning as commonly understood by one of ...

Claims

1. A patient interface comprising: A plenum chamber, the plenum chamber being configured to, in use, provide a pressure of at least 6 cmH above ambient air pressure throughout a patient's breathing cycle. ２ and the plenum chamber is pressurizable to a therapeutic pressure of O. One or more walls; a seal-forming structure constructed and arranged to form a seal against an area of ​​the patient's face surrounding an entrance to the patient's airways, said seal-forming structure including a nose region having at least one nasal hole configured, in use, to deliver an air flow at said therapeutic pressure to an entrance to the patient's nares, said seal-forming structure including a mouth region having a mouth hole configured, in use, to deliver an air flow at said therapeutic pressure to an entrance to the patient's mouth, said seal-forming structure constructed and arranged, in use, to maintain said therapeutic pressure in a plenum chamber throughout the patient's respiratory cycle; one or more plenum chamber inlet ports sized and configured to, in use, receive a flow of air at a therapeutic pressure for breathing by a patient throughout the patient's breathing cycle; a plenum chamber including: a positioning and stabilizing structure configured to generate a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head; Including, The seal forming structure includes: a rearwardly facing lateral portion defining a lateral peripheral support area on either lateral side of the mouth hole; each of said rearwardly facing lateral portions extends medially to form a portion of a peripheral edge of said mouth opening on a corresponding lateral side of said mouth opening; the lateral peripheral support portion is adjacent to the mouth hole periphery at the periphery of the mouth hole, A patient interface wherein the lateral peripheral support regions are stiffer than the peripheral portions of the oral cavity.

2. 2. A patient interface according to claim 1, wherein the lateral peripheral support regions are thicker than the oral aperture perimeter regions.

3. 3. A patient interface according to claim 1 or 2, wherein the seal-forming structure further includes a lower lip that forms a seal against a chin area of ​​a patient, the lower lip being thinner than the rearwardly facing lateral portions.

4. A patient interface according to claim 3, wherein the lower lip is wider at a periphery of the oral aperture than at a lower periphery of the seal-forming structure.

5. A patient interface according to any preceding claim, wherein the seal-forming structure is a single wall seal-forming structure.

6. 6. A patient interface according to any one of claims 1 to 5, wherein the plenum chamber comprises a vent comprising a plurality of holes and constructed and arranged to allow washing out of exhaled gases.

7. 7. A patient interface according to any one of claims 1 to 6, wherein the seal-forming structure comprises a central portion configured to seal against an inferior periphery of the patient's nose in use.

8. 8. A patient interface as described in claim 7, wherein the seal-forming structure comprises a laterally facing rear portion at a non-patient facing lateral region of the nasal region, the laterally facing rear portion having a greater wall thickness than the central portion.

9. 9. A patient interface according to claim 7 or 8, wherein the central portion comprises an upwardly facing central portion and a forwardly facing central portion.

10. A patient interface according to claim 9, wherein the upwardly facing central portion and the forwardly facing central portion have a wall thickness of 0.15 to 0.4 mm.

11. 11. A patient interface according to any preceding claim, wherein the seal-forming structure is configured, in use, not to engage under the chin of the patient's face.

12. 12. A patient interface according to any one of claims 1 to 11, wherein the plenum chamber comprises a single inlet port.

13. 13. A patient interface according to any one of claims 1 to 12, wherein the plenum chamber comprises a shell, and the seal-forming structure is connected to the shell.

14. 14. A patient interface according to claim 13, wherein the shell is constructed from polycarbonate and the seal-forming structure is formed from silicone.

15. the positioning and stabilizing structure comprises a frame and a number of headgear straps connected to the frame; 15. A patient interface according to any one of claims 1 to 14, wherein the plenum chamber is connected to the frame via a snap-fit ​​connection.

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