Seal-forming structure, positioning and stabilization structure, and diffuser vent for patient interface

Abstract

To provide a seal-forming structure for an improved patient interface. [Solution] A patient interface that delivers an airflow to the entrance of a patient's airway at a positive pressure relative to the ambient air pressure in order to improve sleep-disordered breathing includes a frame assembly and a cushion assembly that is removable and repeatably connected thereto. The frame assembly and cushion assembly form part of a plenum chamber that can be pressurized up to a therapeutic pressure. The cushion assembly includes a one-piece structure that includes a seal-forming structure that seals against the patient's facial area surrounding the entrance to the patient's airway and a frame-connecting structure that removablely connects the cushion assembly to the frame assembly. The seal-forming structure includes a first elastomer material, and the frame-connecting structure includes a second elastomer material, wherein the first elastomer material has a lower durometer or hardness than the second elastomer material.

Description

Technical Field

[0001] Part of the disclosure of this patent document contains content that is protected by copyright. The copyright owner has no objection if someone reproduces this patent document or this patent disclosure by fax, as long as it is what is described in the patent file or record of the Patent Office and for the purpose, but retains all copyrights for other purposes.

[0002] 1 Cross - reference to related applications This application claims the benefit of U.S. Provisional Patent Application No. 62 / 830,745 (filing date: April 8, 2019), and U.S. Provisional Patent Application No. 62 / 830,764 (filing date: April 8, 2019). The entire content of the same is incorporated herein by reference.

Background Art

[0003] 2 Background of the technology 2.1 Field of the technology This technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory - related diseases. This technology also relates to medical devices or apparatuses and their use.

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

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

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

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

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by the onset of closure or obstruction of the upper airway during sleep. This results from a combination of an abnormally small upper airway, normal loss of muscle tone in the tongue region, and normal loss of the soft palate and posterior oropharyngeal wall during sleep. As a result of this condition, respiratory cessation in affected patients typically lasts 30 to 120 seconds, sometimes as many as 200 to 300 times a night. Consequently, excessive daytime sleepiness occurs, which can lead to cardiovascular disease and brain injury. This condition is common, particularly prevalent in overweight middle-aged men, although patients often have no subjective symptoms. See Patent Document 1 (U.S. Patent No. 4,944,310: Sullivan).

[0009] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, characterized by alternating, cyclical increases and decreases in ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. Due to recurrent hypoxia, CSR can be harmful. In some patients, CCR is accompanied by recurrent sleep-wake cycles, which cause severe insomnia, increased sympathetic activity, and increased afterload. See Patent Document 2 (U.S. Patent No. 6,532,959: Berthon-Jones).

[0010] Respiratory failure is a general term for respiratory disorders in which the lungs are unable to produce enough oxygen inhalation or CO2 exhalation to meet the patient's needs. Respiratory failure may encompass some or all of the following conditions:

[0011] Patients with respiratory failure (a type of respiratory failure) may experience abnormal shortness of breath during exercise.

[0012] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia while awake, in the absence of other clearly identifiable causes of hypoventilation. Symptoms include shortness of breath, morning headache, and excessive daytime sleepiness.

[0013] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics. These include increased resistance to air movement, prolonged expiratory phase of respiration, and reduced normal elasticity in the lungs. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational radiation exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0014] Neuromuscular diseases (NMDs) are a broad term encompassing numerous illnesses and diseases that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage, which can lead to inability to walk, wheelchair confinement, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified into rapidly progressive and slowly progressive types: (i) Rapidly progressive disorders: characterized by muscle damage that worsens over several months and leads to death within several years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: characterized by muscle damage that worsens over several years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increased general weakness, dysphagia, dyspnea at exertion and rest, fatigue, drowsiness, morning headache, and difficulty concentrating and changing mood.

[0015] Chest wall disorders are a group of thoracic deformities that cause dysfunction in the connection between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive disorders and share the potential for long-term excess carbon dioxide respiratory failure. Scoliosis and / or kyphosis can develop into severe respiratory failure. Symptoms of respiratory failure include: exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0016] A range of treatments are used to treat or improve such conditions. Furthermore, otherwise healthy individuals can also take advantage of preventive treatments for respiratory diseases. However, these have several drawbacks.

[0017] 2.2.2 Treatment A variety of therapies (e.g., continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), and invasive ventilation (IV)) are used to treat one or more of the respiratory diseases mentioned above.

[0018] Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action involves, for example, pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, allowing CPAP to function as an air splint, thereby preventing upper airway obstruction. Since CPAP treatment for OSA can be voluntary, patients may choose not to adhere to treatment if they notice one or more of the following regarding the device used to deliver the treatment: discomfort, difficulty of use, high cost, or lack of aesthetic appeal.

[0019] Non-invasive ventilation (NIV) provides ventilatory support to the patient through the upper airway to assist with breathing and / or maintain adequate oxygen levels throughout the body by performing some or all of the respiratory function. Ventilation support is provided through a non-invasive patient interface. NIV is used to treat forms of respiratory failure and pulmonary stenosis, such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0020] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0021] 2.2.3 Treatment System These treatments may be provided by treatment systems or devices. Such systems and devices may also be used for screening, diagnosing, or monitoring diseases without treating them.

[0022] The treatment system may include a respiratory pressure therapy device (RPT device), air circuitry, humidifier, patient interface, and data management.

[0023] Another form of treatment system is the mandibular repositioning device.

[0024] 2.2.3.1 Patient Interface The patient interface can be used to provide an interface to the wearer to the breathing apparatus, for example by providing an air flow to the airway inlet. The air flow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can form a seal with the area of the patient's face, thereby promoting gas delivery at a sufficient distributed pressure together with the atmospheric pressure for therapy execution (e.g., at a positive pressure of about 10 cmH2O relative to the atmospheric pressure). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to promote delivery of gas supply to the airway at a positive pressure of about 10 cmH2O.

[0025] Certain other mask systems may be functionally inappropriate in the art. 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 swimming or diving underwater can be configured to protect against water intrusion from higher external pressures and not maintain internal air at a pressure higher than the ambient.

[0026] Certain masks may be clinically unfavorable in the present technology (e.g., when the mask blocks the air flow through the nose and only allows air flow through the mouth).

[0027] In certain masks, it may be uncomfortable or impractical in the present technology when the patient has to insert a part of the mask structure into the mouth and create and maintain a seal through the lips.

[0028] Certain masks may be impractical for use during sleep (e.g., when sleeping on the bed on the side with the head on the pillow).

[0029] There are several challenges in designing 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. Because the head contains bone, cartilage, and soft tissue, different areas of the face respond differently 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 treatment period.

[0030] Due to these challenges, some masks, especially when worn for extended periods or when the patient is unfamiliar with the system, may be intrusive, aesthetically undesirable, expensive, poorly fitting, difficult to use, and uncomfortable for one or more reasons. Using an incorrectly sized mask can lead to decreased compliance, reduced comfort, and a poorer patient outcome. While pilot-specific masks, personal protective equipment (e.g., filter masks), masks designed as part of a SCUBA mask, or masks used for anesthesia may be tolerable for their original purpose, they can be undesirable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient compliance with treatment, especially if the mask needs to be worn during sleep.

[0031] CPAP therapy is highly effective in treating certain respiratory conditions, provided the patient consents to the treatment. Patients may refuse treatment if the mask is uncomfortable or difficult to use. Since patients are often advised to wash their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may be unable to clean the mask, which can affect patient compliance.

[0032] Masks designed for other purposes (e.g., pilot use) may be unsuitable for treating sleep-disordered breathing, while masks designed for treating sleep-disordered breathing may be suitable for other purposes.

[0033] For these reasons, the patient interface for CPAP delivery during sleep forms a distinct field.

[0034] 2.2.3.1.1 Seal-forming structure 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.

[0035] Patient interfaces can be partially characterized according to the design intent of where the seal-forming structure engages with the face during use. In one form of patient interface, the seal-forming structure may include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and nasal bridge region of the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the oral region by forming a seal, for example, on the lower lip region of the face during use. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the oral region during use. These different types of patient interfaces may be known by various names such as nasal masks, full-face masks, nasal pillows, nasal puffs, and mouth-nasal masks, depending on their manufacturer.

[0036] A sealing structure that may be effective in one area of ​​a patient's face may be unsuitable in another area due to, for example, different facial shapes, structures, variability, and sensitive areas of the patient's face. For instance, the sealing portion of swimming goggles that rests on a patient's forehead may be unsuitable for use over the patient's nose.

[0037] A specific seal-forming structure can be designed for mass production so that a single design fits a wide range of different face shapes and sizes, ensuring comfort and effectiveness. To form the sealing portion, one or both the patient's face shape and the mass-produced patient interface seal-forming structure must be adapted to a certain extent, even if there is some mismatch between them.

[0038] One type of seal-forming structure extends around the periphery 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 with the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or it may include a molded or formed surface of an elastic sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will form between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0039] Another type of seal-forming structure uses a thin flap seal positioned around the perimeter of the mask to provide a self-airtight seal against the patient's face when positive pressure is applied inside the mask. Similar to the previously mentioned types of seal-forming structures, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or leakage may occur from the mask. Furthermore, if the shape of the seal-forming structure does not conform to the patient's shape, creases or buckling may occur in the seal-forming portion during use, leading to leakage.

[0040] Other types of seal-forming structures may include, for example, friction-fitting elements inserted into the nostrils, but some patients may find these seal-forming parts uncomfortable.

[0041] Another form of seal-forming structure may use adhesive to achieve a seal. Some patients may find it inconvenient to constantly attach or remove the adhesive to their face.

[0042] The technology for forming a patient interface seal within a certain range is disclosed in the following patent applications (assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785).

[0043] 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.), which was transferred to Puritan-Bennett Corporation.

[0044] 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 examples of nose pillow masks: International Patent Application WO2004 / 073, 778 (in particular, describing the features of ResMed Limited's SWIFT® nose pillow); U.S. Patent Application 2009 / 0044808 (in particular, describing the features of ResMed Limited's SWIFT® LT nose pillow); International Patent Applications WO2005 / 063, 328 and WO2006 / 130, 903 (in particular, describing the features of ResMed Limited's MIRAGE LIBERTY® full-face mask); International Patent Application WO2009 / 052, 560 (in particular, describing the features of ResMed Limited's SWIFT® FX nose pillow).

[0045] 2.2.3.1.2 Positioning and Stabilization The seal-forming structures of patient interfaces used in positive pressure air therapy are subjected to corresponding forces from the air pressure that can disrupt the seal. Therefore, various techniques are employed to position the seal-forming structures and maintain a seal over the appropriate portion of the face.

[0046] In one technology, adhesive joints are used. For example, see U.S. Patent Application Publication US2010 / 0000534. However, the use of adhesive joints can sometimes cause discomfort.

[0047] In other technologies, one or more straps and / or stabilization harnesses are used. In many such harnesses, one or more of the following apply: poor fit, bulkiness, discomfort, and difficulty of handling.

[0048] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices can be used individually or as part of a system for the delivery of one or more of the above-mentioned therapies, for example, by activating the device to generate an air delivery flow to the airway interface. This air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0049] Pneumatic generators are well known in a wide range of applications (e.g., industrial-scale ventilation systems). However, pneumatic generators for medical applications have specific requirements that cannot be satisfied by more general pneumatic generators (e.g., reliability, size, and weight requirements for medical devices). In addition, even devices designed for medical treatment may not be free from defects related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0050] One example of a specific requirement for a particular RPT device is acoustic noise.

[0051] Table of noise output levels of conventional RPT devices (measured using only one sample in CPAP mode at 10 cmH2O using the test method specified in ISO 3744). [Table 1]

[0052] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another embodiment of an RPT device is the ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can provide assistance for invasive and non-invasive independent breathing for a range of patients for the treatment of multiple conditions (e.g., NMD, OHS, and COPD).

[0053] The ResMed Elis Accent Aigu ee® 150 ventilators and ResMed VSIII® ventilators can provide invasive and non-invasive dependent respiratory support suitable for adult or pediatric patients for the treatment of multiple conditions. These ventilators provide volumetric and pneumatic ventilation modes using single or dual limb circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) and are configured to supply airflow to the patient's airway. In some cases, the airflow may be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface as described above via an air circuit.

[0054] Device designers may be presented with countless options. Because design criteria often conflict, certain design choices may be far removed from convention, or even unavoidable. Furthermore, the comfort and effectiveness of a particular design can be significantly affected by even minor changes in one or more parameters.

[0055] 2.2.3.3 Humidifier Delivering airflow without humidification can lead to airway dryness. Using a humidifier with the RPT device and patient interface generates humidifying gas, minimizing nasal mucosal dryness and increasing patient airway comfort. Additionally, in cooler climates, adding warm air to the facial area around the patient interface generally provides greater comfort than cool air.

[0056] While a certain range of artificial humidification devices and systems are publicly known, they do not meet the specific requirements of medical humidifiers.

[0057] Medical humidifiers are typically used to increase the humidity and / or temperature of an airflow relative to the ambient air as needed, when a patient is sleeping or at rest (e.g., in a hospital). Medical humidifiers placed by the bedside may be small in size. They may be configured to humidify and / or heat only the airflow delivered to the patient, and not the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can humidify the air inhaled into the patient's body through breathing, but these systems also humidify and / or heat the entire room, which can be uncomfortable for the occupant. Furthermore, medical humidifiers may have stricter safety constraints than industrial humidifiers.

[0058] Although numerous medical humidifiers are publicly known, these humidifiers may suffer from one or more defects. Specifically, some medical humidifiers may not humidify properly, or they may be difficult or inconvenient for patients to use.

[0059] 2.2.3.4 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant" (for example, whether the patient is using their RPT device in accordance with one or more "compliance rules"). For example, a compliance rule for CPAP therapy might require a patient to use their RPT device for at least four hours per night for at least 21 consecutive days out of a 30-day period in order to be considered compliant. To determine patient compliance, an RPT device provider (e.g., a healthcare provider) may manually collect data describing the patient's treatment with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. Once a healthcare provider determines that a patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify third parties that the patient is compliant.

[0060] In patient treatment, there may be other ways in which communication of treatment data to third parties or external systems may be beneficial.

[0061] Existing processes for communicating and managing such data can be costly, time-consuming, and prone to errors.

[0062] 2.2.3.5 Repositioning of the mandible Mandibular repositioning devices (MRDs) or mandibular anterior fixation devices (MADs) are one of the treatment options for sleep apnea and snoring. These are adjustable oral appliances available from dentists or other suppliers that hold the mandible (lower jaw) in an anterior position during sleep. MRDs are removable devices, inserted into the patient's mouth before sleep and removed after sleep. Therefore, MRDs are not designed for continuous wear. MRDs may be custom-made or manufactured in standard forms and include an occlusal impression site designed to fit the patient's teeth. This mechanical projection from the mandible expands the space behind the tongue, adds tension to the pharyngeal wall, reduces airway collapse, and reduces palatal vibration.

[0063] In certain embodiments, the mandibular anterior fixation device may include an upper splint intended to engage with or interlock with teeth on the maxilla or maxilla, and a lower splint intended to engage with or interlock with teeth on the maxilla or mandible. The upper and lower splints are connected laterally to each other via a pair of connecting rods. This pair of connecting rods is fixed symmetrically on the upper and lower splints.

[0064] In this design, the length of the connecting rod is selected so that the mandible is held in an anterior position when the MRD is placed in the patient's oral cavity. The length of the connecting rod can be adjusted to change the level of mandibular protrusion. The dentist can determine the level of protrusion to match the mandible, and the length of the connecting rod is determined accordingly.

[0065] Some MRDs are configured to push the mandible forward relative to the maxilla, while others, like other MADs such as the ResMed Narval CC® MRD, are designed to hold the mandible in an anterior position. This device also reduces or minimizes dental and temporal / mandibular joint (TMJ) side effects. Therefore, the device is configured to minimize or avoid any movement of one or more teeth.

[0066] 2.2.3.6 Ventilation Technology Some forms of treatment systems may include vents to expel exhaled carbon dioxide. These vents may allow gas to 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).

[0067] These vents may include orifices, through which gas can flow when the mask is in use. In the case of numerous such vents, noise is generated. In other cases, they may become blocked during use, resulting in insufficient airflow. In some cases, the sleep of the patient 1000 and the person sharing the bed 1100 may be disturbed, for example, due to noise or concentrated airflow.

[0068] ResMed Limited has developed several improved mask ventilation technologies. See below: International Patent Application Publication WO1998 / 034,665; International Patent Application Publication WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication US2009 / 0050156; U.S. Patent Application Publication 2009 / 0044808.

[0069] Table of noise levels for conventional masks (ISO 17510-2:2007, 10 cmH2O pressure at 1 m) [Table 2]

[0070] (*Only one sample was measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744.)

[0071] The sound pressure values ​​of various objects are listed below. [Table 3]

[0072] 2.2.4 Screening, diagnostic, and monitoring systems Polysomnography (PSG) is a conventional system for the diagnosis and monitoring of cardiopulmonary disorders, and typically requires specialized clinical staff for system application. PSG typically involves placing 15-20 tactile sensors on the body to record various bodily signals (e.g., electroencephalography (EEG), electrocardiogram (ECG), electrooculography (EOG), and electromyography (EMG)). For PSG of sleep-disordered breathing, patients needed to be observed over two nights in a specialized hospital; the first night was purely for diagnosis, and the second night was necessary for clinicians to titrate treatment parameters. Therefore, PSG is costly and inconvenient. Screening / diagnosis / monitoring of sleep-disordered breathing is particularly unsuitable for home use.

[0073] Generally, screening and diagnosis involve identifying a disease based on its signs and symptoms. Screening typically yields true / false results indicating whether a patient's SDB warrants further investigation, while diagnosis often provides clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the course of a disease can continue indefinitely. Some screening / diagnostic systems are designed solely for screening / diagnosis, while others can also be used for monitoring.

[0074] Clinical professionals can appropriately screen, diagnose, or monitor patients based on visual observation of PSG signals. However, there are situations where clinical professionals are unavailable or cannot be paid. Clinical professionals may have differing opinions regarding a patient's condition. Furthermore, a particular clinical professional may apply different criteria over time. [Prior art documents] [Patent Documents]

[0075] [Patent Document 1] U.S. Patent No. 4,944,310 [Patent Document 2] U.S. Patent No. 6,532,959 [Overview of the Initiative] [Means for solving the problem]

[0076] 3. A brief explanation of the technology This technology relates to the provision of medical devices used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases, which have one or more of the following advantages: improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0077] A first aspect of this technology relates to a device used for screening, diagnosing, monitoring, improving, treating or preventing respiratory diseases.

[0078] Another aspect of this technology relates to a method used in screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0079] One aspect of a particular form of this technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0080] Another aspect of the present technology relates to a patient interface which may include: a plenum chamber, a seal-forming structure, and a positioning and stabilizing structure. The patient interface may further include a ventilation structure. The patient interface may be further configured to leave the patient's oral cavity exposed, or, if the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface may be further configured to allow the patient to breathe from the atmosphere through their oral cavity when there is no pressurized airflow through the plenum chamber inlet port.

[0081] Another aspect of the present technology relates to a patient interface which may include: a plenum chamber pressurized to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's respiration; a seal-forming structure constructed and positioned to seal against a region of the patient's face surrounding an inlet to the patient's airway, the seal-forming structure having a hole therein, thereby allowing airflow at the therapeutic pressure to be delivered at least to the inlet to the patient's nostrils, and the seal-forming structure constructed and positioned to maintain the therapeutic pressure within the plenum chamber for the entire respiratory cycle of the patient during use; and a position configured to hold the seal-forming structure in a therapeutically effective position on the patient's head. A positioning and stabilizing structure, the positioning and stabilizing structure includes a tie, the tie being constructed and positioned so that at least a portion of the tie rests on a region of the patient's head above the superior base of the patient's head when in use; and a ventilation structure configured to allow gas exhaled by the patient to flow continuously from inside the plenum chamber outwards, the ventilation structure being sized and shaped to maintain therapeutic pressure within the plenum chamber when in use; wherein the patient interface is further configured to leave the patient's oral cavity exposed, or, if a seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface is configured to allow the patient to breathe out of the atmosphere through their oral cavity when there is no pressurized airflow through the plenum chamber inlet port.

[0082] Aspects of this technology relate to a patient interface including a frame assembly and a cushion assembly configured to be removable and repeatably connected to the frame assembly. The cushion assembly includes a one-piece structure including a seal-forming structure constructed and positioned to form a seal against the patient's facial region surrounding the entrance to the patient's airway, and a frame-connecting structure constructed and positioned to allow the cushion assembly to be removable and repeatably connected to the frame assembly. The seal-forming structure comprises a first elastomer material, and the frame-connecting structure comprises a second elastomer material, wherein the first elastomer material comprises a lower durometer or hardness than the second elastomer material.

[0083] In one example, the first elastomer material and the second elastomer material may each include TPE or a silicone material.

[0084] One aspect of the present technology relates to a patient interface for improving sleep-disordered breathing by delivering an airflow at positive pressure relative to ambient air pressure to the entrance to the patient's airway, including at least the patient's nostril inlet, during the patient's sleep. The patient interface includes a frame assembly and a cushion assembly configured to be removable and repeatably connected to the frame assembly. The frame assembly and cushion assembly form at least a portion of a plenum chamber pressurized to a therapeutic pressure. The cushion assembly includes a one-piece structure including a seal-forming structure constructed and positioned to form a seal against the patient's facial region surrounding the entrance to the patient's airway, and a frame-connecting structure constructed and positioned to allow the cushion assembly to be removable and repeatably connected to the frame assembly. The seal-forming structure comprises a first elastomer material, and the frame-connecting structure comprises a second elastomer material, wherein the first elastomer material comprises a lower durometer or hardness than the second elastomer material. The frame-connecting structure includes an undercut that functions as an interface or catch adapted for connection to the frame assembly. The frame connection structure is positioned along the inner surface or inner circumference of the seal-forming structure such that the frame connection structure and its undercuts are positioned or oriented toward the inside of the cushion assembly that forms at least a portion of the plenum chamber.

[0085] In one example, the seal-forming structure may include a nasal cradle cushion adapted to form a seal at least to the underside of the patient's nose. In one example, the seal-forming structure and the frame connection structure may include an overmolded structure for forming a one-piece integrated component. In one example, the frame connection structure may include a base mold, and the seal-forming structure may include an overmolded portion provided on the base mold. In one example, the first elastomer material and the second elastomer material may each include TPE or a silicone material. In one example, the frame connection structure may include one or more interface surfaces structured to be joined to the seal-forming structure. In one example, the durometer of the first elastomer material may be in the range of 30 to 50 Shore A, and the durometer of the second elastomer material may be in the range of 60 to 90 Shore A. In one example, the patient interface may further include a sealing lip provided on the seal-forming structure of the first elastomer material, the sealing lip being structured and positioned to form a seal with the frame assembly. In one example, the frame assembly may be relatively more rigid than the frame connection structure. In another example, the frame connection structure and its undercuts may extend around the entire periphery and inner surface of the seal-forming structure.

[0086] Another aspect of the present technology relates to a patient interface including a positioning and stabilizing structure that provides a force to hold a seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes a first strap including an elastic material, a second strap including an elastic material, and a buckle. The buckle is constructed and arranged to connect the first strap to the second strap and to allow length adjustment in addition to the length adjustment provided by the elasticity of the first and second straps.

[0087] Another aspect of the present technology relates to a patient interface for improving sleep-disordered breathing by delivering an airflow at positive pressure relative to ambient air pressure to the entrance to the patient's airway, including at least the patient's nostril inlets, during the patient's sleep. The patient interface includes a seal-forming structure constructed and positioned to form a seal with a region of the patient's face surrounding the entrance to the patient's airway, and a positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes a first strap including an elastic woven material, a second strap including an elastic woven material, and a buckle. The buckle is constructed and positioned to connect the first strap to the second strap and to allow length adjustment in addition to the length adjustment provided by the elasticity of the first and second straps. The first strap includes a side strap portion. The side strap portion branches into two back strap portions. The second strap includes a side strap portion. The side strap portion of the second strap includes an end connected to a buckle in an immovable manner, and the two back strap portions of the first strap are threaded through the buckle to allow the first strap to be adjusted to the buckle and to be length adjusted. The buckle includes a first opening and a pair of second openings, and the buckle includes a crossbar that demarcates the first opening from the pair of second openings. The two back strap portions of the first strap are threaded through the first opening around the crossbar and through one of each of the pair of second openings to allow the two back strap portions of the first strap to be adjusted to the buckle. The side strap portions of each first and second strap are fitted to extend along the side of the patient's head, and the two back strap portions of the first strap are fitted to extend along the back of the patient's head.

[0088] In one example, the first strap may be longer than the second strap when it is at its original length in a neutral, unstretched state. In one example, one of the two back strap portions may be fitted to be positioned above the patient's occipital lobe, and the other of the two back strap portions may be fitted to be positioned below the patient's occipital lobe. In one example, the buckle may include a first end and a second end, the second end being connected to the end of the side strap portion of the second strap, and the first end may be curved or angled upward relative to the second end. In one example, each of the pair of second openings may include an angled edge or surface positioned to withstand adjustment during use. In one example, the buckle may include a locked position to withstand accidental adjustments resulting from friction between the two backstrap portions and the angled edges or surfaces within each second opening when the buckle extends generally parallel to the two backstrap portions, and an unlocked position when the buckle is raised or swiveled to allow adjustments resulting from reduced friction between the two backstrap portions and the angled edges or surfaces within each second opening. In one example, the positioning and stabilizing structure may further include a pair of rigidizer arms, with the side strap portions of the first and second straps provided on each of the pair of rigidizer arms. In one example, each side strap portion may include a tubular configuration adapted to receive each of the rigidizer arms. In one example, each end of the first strap may include a reinforcement, and the second strap may include the opposite end to the end connected to the buckle containing the reinforcement, and the material of each reinforcement may be different from the material of the first and second straps.

[0089] Aspects of this technology relate to a patient interface that includes a ventilator structured and arranged to improve the diffusion rate of airflow in order to minimize noise during use.

[0090] Aspects of this technology relate to a patient interface that includes a ventilation section together with a flow divider that splits the airflow.

[0091] Aspects of this technology relate to a patient interface that includes a ventilation section equipped with one or more venting members for dispersing an airflow, and a flow divider for dividing the airflow into spaced-out ventilation channels around the patient interface.

[0092] Aspects of this technology relate to a patient interface for improving sleep-disordered breathing by delivering an airflow at positive pressure relative to ambient air pressure to the entrance to the patient's airway, including at least the entrance to the patient's nostrils, during the patient's sleep. The patient interface is a seal-forming structure constructed and positioned to form a seal with a region of the patient's face surrounding the entrance to the patient's airway, the seal-forming structure comprising the seal-forming structure forming at least a portion of a plenum chamber pressurized to a therapeutic pressure, and a ventilation assembly configured to provide a gas airflow to discharge gas exhaled by the patient from the plenum chamber to the surroundings. The ventilation assembly comprises a body including a plurality of orifices extending through the body to allow gas to be released from the plenum chamber into the ambient atmosphere, a venting member configured and positioned such that the plurality of orifices are covered by the venting member so that the ventilation gas flow passes through the venting member, and a plurality of ribs. The multiple ribs are configured and arranged to support venting members that are spaced apart from the outlet ends of each of the multiple orifices, and to divide the aeration gas flow into spaced aeration channels downstream of the venting members around the main body.

[0093] In one example, the diffusion member may include a filter material. In one example, the multiple orifices may be arranged in an arc or U shape. In one example, the multiple ribs may be arranged along the outer circumference of the multiple orifices to support the outer edge of the diffusing member. In one example, the ventilation assembly may further include a spacer provided in the main body, the spacer being arranged along the inner circumference of the multiple orifices to support the diffusing member. In one example, the patient interface may further include a cover that holds the diffusing member in the main body. In one example, the main body and cover may form a diffusing section including a diffusing section inlet and a diffusing section outlet, and the multiple ribs may be arranged within the diffusing section between the diffusing section inlet and outlet to divide the ventilation gas flow. In one example, the diffusing section inlet may be provided by the outlet ends of each of the multiple orifices. In one example, the multiple ribs and the diffusing member may be provided within a recessed area of ​​the main body, and the diffusing section outlet may be provided by a gap formed between the cover and the periphery of the recessed area. In one example, the outlet of the venting section may be spaced outward in the radial direction from the inlet of the venting section. In one example, the ribs may be structured and arranged in such a way that they divide the turbulent kinetic energy at the inlet of the venting section into portions toward the outlet of the venting section. In one example, the ribs may be structured and arranged in such a way that they divide the turbulent kinetic energy into substantially equal portions. In one example, one or more of the ribs may be provided on the cover. In one example, one or more of the ribs may include a one-piece structure together with the cover. In one example, each of the ribs may extend in a direction generally perpendicular to the main surface of the body. In one example, the orifices may include a first porous ventilation configuration, and the ventilation assembly may further include a second porous ventilation configuration spaced apart from the first porous ventilation configuration, the second porous ventilation configuration including multiple orifices extending through the body. In one example, the ventilation assembly may further include a second radiating member configured and positioned to cover a plurality of orifices of the second porous ventilation configuration, and the plurality of ribs may include ribs configured and positioned to support the second radiating member.In one example, the patient interface may further include a frame assembly, and a seal-forming structure may be provided on the frame assembly. In one example, the body of the ventilation assembly may be provided by the frame assembly. In one example, the frame assembly may include connection ports adapted to connect to an air delivery conduit. In one example, multiple orifices may be configured and arranged to avoid cross-flow. In one example, one or more of multiple ribs may be provided on the body. In one example, one or more of multiple ribs may include a one-piece structure together with the body.

[0094] Aspects of this technology relate to a patient interface for improving sleep-disordered breathing by delivering an airflow at positive pressure relative to ambient air pressure to the entrance to the patient's airway, including at least the patient's nostril inlet, during the patient's sleep. The patient interface is a seal-forming structure constructed and positioned to form a seal with a region of the patient's face surrounding the entrance to the patient's airway, the seal-forming structure comprising the seal-forming structure forming at least a portion of a plenum chamber pressurized to therapeutic pressure, and a vent configured to provide a gas airflow to expel gas exhaled by the patient from the plenum chamber to the surroundings. The vent comprises a body including a plurality of orifices extending through the body to allow gas to be released from the plenum chamber into the ambient atmosphere. The body includes at least one protrusion or rib providing a surface area, the outlet end of each of the plurality of orifices being positioned along the surface area.

[0095] In one example, the body may include a plurality of raised or ribs that provide spaced-apart surface areas, and the exit end of each of the plurality of orifices may be positioned along each of the spaced-apart surface areas. In one example, the plurality of raised or ribs may be positioned to provide a stepped arrangement of surface areas. In one example, the spaced-apart surface areas may be generally parallel to each other. In one example, the plurality of orifices may be positioned in rows, and each of these rows may be positioned along each of the spaced-apart surface areas. In one example, the plurality of orifices may include a first porous ventilation arrangement, and the ventilation may further include a second porous ventilation arrangement positioned spaced apart from the first porous ventilation arrangement, and the second porous ventilation arrangement may include a plurality of orifices extending through the body. In one example, the patient interface may further include a frame assembly, and a seal-forming structure may be provided on the frame assembly. In one example, the main body of the ventilation section may be provided by a frame assembly.

[0096] Aspects of this technology relate to a CPAP system that provides a patient with positively pressurized gas for respiratory therapy. The CPAP system includes an RPT device configured to supply a gas flow at therapeutic pressure, a patient interface, and an air delivery conduit configured to deliver a gas flow from the RPT device to the patient interface at therapeutic pressure.

[0097] Another aspect of one form of this technology is a patient interface molded or otherwise constructed together with a peripheral shape that is complementary to the shape of the intended wearer.

[0098] One embodiment of this technology is a method for manufacturing an apparatus.

[0099] One particular aspect of this technology is a medical device that is easy to use for, for example, a person who has not received medical training, a person who is not very dexterous or lacks insight, or a person who has limited experience using this type of medical device.

[0100] One embodiment of this technology is a patient interface that can be cleaned at the patient's home, for example, with soapy water, and does not require any special cleaning equipment.

[0101] Of course, some of the above embodiments may form sub-embodiments of the present technology. Furthermore, various combinations of sub-embodiments and / or various other embodiments may constitute even further embodiments or sub-embodiments of the present technology.

[0102] Other features of this technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims.

[0103] 4. Brief Description of the Drawings This technology is illustrated in the attached drawings as a non-limiting embodiment. In the drawings, similar reference numerals include the following similar elements: [Brief explanation of the drawing]

[0104] [Figure 1A] 4.1 Treatment System: The system includes a patient 1000 wearing a patient interface 3000. This system takes the form of a nasal pillow and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device 4000 is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. A bedmate 1100 is also illustrated. The patient is sleeping in a supine sleeping position. [Figure 1B] The system includes a patient 1000 wearing a patient interface 3000. This system takes the form of a nasal mask and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. [Figure 1C]The system includes a patient 1000 wearing a patient interface 3000. The patient interface 3000 removes a full face mask and receives positive pressure air from an RPT device 4000. The air from the RPT device is humidified by a humidifier 5000 and travels to the patient 1000 along an air circuit 4170. The patient is sleeping in a lateral sleeping position. 4.2 Respiratory system and facial anatomy [Figure 2A] This diagram outlines the human respiratory system, including the nasal and oral cavities, larynx, vocal cord folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] This is a diagram of the human upper respiratory tract, including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cord folds, esophagus, and trachea. [Figure 2C] This is a frontal view of the face including several features of surface anatomical structures, including the upper lip, upper lip robe, lower lip robe, lower lip, width of the mouth, medial canthus, nasal wings, nasolabial folds, and corners of the mouth. The superior, inferior, radially medial, and radially lateral directions are also indicated. [Figure 2D] This is a lateral view of the head, including several features of surface anatomical structures, such as the glabella, therion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, ala apex, superior and inferior base of the ear. The superior and inferior, and anterior and posterior directions are also indicated. [Figure 2E] This is a further lateral view of the head. The approximate positions of the Frankforth horizontal and nasolabial angles are indicated. The coronal plane is also shown. [Figure 2F] This is a pedicle view of the nose, including several features such as the nasolabial folds, lower lip, upper lip red, nostrils, subnasal point, columella, nasal tip, main axis of the nostrils, and median sagittal plane. [Figure 2G] This is a lateral view of the surface features of the nose. [Figure 2H] This shows the subcutaneous structure of the nose, including the lateral nasal cartilage, nasal septal cartilage, greater alar cartilage, lesser alar cartilage, nasal sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibrous adipose tissue. [Figure 2I]This shows a mid-nasal incision located approximately a few millimeters from the midline sagittal plane, particularly the medial crura of the nasal septum cartilage and the greater alar cartilage. [Figure 2J] This is a frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae are shown together with the maxilla and mandible. [Figure 2K] This is a lateral view of the skull showing the external shape of the head surface and several muscles. The following bones are illustrated: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is illustrated. The following muscles are illustrated: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle. [Figure 2L] An anterior lateral view of the nose is shown. 4.3 Patient Interface [Figure 3A] This shows a patient interface in the form of a nasal mask, which is one embodiment of this technology. [Figure 3B] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively large compared to the magnitude of curvature shown in 3C. [Figure 3C] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively small compared to the magnitude of curvature shown in Figure 3B. [Figure 3D] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature value at this point is zero. [Figure 3E] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively small compared to the magnitude of curvature shown in Figure 3F. [Figure 3F] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively large compared to the curvature shown in Figure 3E. [Figure 3G]A mask cushion containing two pillows is shown. The outer surface of the cushion is illustrated. The edges of the surface are illustrated. The dome region and saddle region are illustrated. [Figure 3H] A mask cushion is shown. The outer surface of the cushion is illustrated. The edges of the surface are illustrated. The path on the surface between point A and point B is illustrated. The straight-line distance between A and B is illustrated. Two saddle-shaped regions and a dome-shaped region are illustrated. [Figure 3I] The surface of the structure is shown, and one-dimensional holes are present within this surface. The planar curves in the illustration form the boundaries of the one-dimensional holes. [Figure 3J] This is a cross-sectional view through the structure in Figure 3I. The illustrated surface defines the two-dimensional hole in the structure in Figure 3I. [Figure 3K] Figure 3I is a perspective view of the structure including two-dimensional and one-dimensional holes. The surfaces that define the two-dimensional holes in the structure of Figure 3I are also shown. [Figure 3L] This shows a mask with an inflatable bladder that acts as a cushion. [Figure 3M] Figure 3L is a cross-sectional view of the mask, showing the inner surface of the bladder. The inner surface defines the two-dimensional holes within the mask. [Figure 3N] Figure 3L shows a further cross-section through the mask. The inner surface is also illustrated. [Figure 3O] This demonstrates the left-hand rule. [Figure 3P] I will demonstrate the right-hand rule. [Figure 3Q] Shows the left ear, including the left ear spiral. [Figure 3R] Shows the right ear, including the right ear spiral. [Figure 3S] The right hand shows a spiral. [Figure 3T] This is a diagram of a mask that includes a sign of the twist of the spatial curve defined by the edges of the sealing membrane in different regions of the mask. [Figure 3U] This is a diagram of the plenum chamber 3200, showing the median sagittal plane and the central contact surface. [Figure 3V]Figure 3U is a rear view of the plenum chamber. The directions in the figure are perpendicular to the central contact surface. In Figure 3V, the plenum chamber is divided into left-hand and right-hand sides by the median sagittal plane. [Figure 3W] Figure 3V is a cross-sectional view through the plenum chamber, taken in the median sagittal plane shown in Figure 3V. The "central contact" surface is illustrated. The central contact surface is perpendicular to the median sagittal plane. The orientation of the central contact surface corresponds to the orientation of tendon 3210. Tendon 3210 rests on the median sagittal plane and contacts the cushion of the plenum chamber only at two points on the median sagittal plane (i.e., upper point 3220 and lower point 3230). Depending on the geometry of the cushion in this region, the central contact surface may contact both the upper and lower points. [Figure 3X] Figure 3U shows the plenum chamber 3200 in the position for use on the face. The median sagittal plane of the plenum chamber 3200 generally coincides with the median sagittal plane of the face when the plenum chamber is in the position for use. The central contact surface generally corresponds to the "face plane" when the plenum chamber is in the position for use. In Figure 3X, the plenum chamber 3200 is a nasal mask, with the upper point 3220 resting approximately on the serion and the lower point 3230 resting on the upper lip. 4.4 Patient Interface with This Technology [Figure 4] This is a perspective view of a patient interface shown on the patient's head according to one embodiment of this technology. [Figure 5] Figure 4 is a perspective view of a patient interface according to one embodiment of this technology. [Figure 6] Figure 5 is a side view of the patient interface. [Figure 7] Figure 5 is a perspective view of the patient interface according to one embodiment of this technology, and the patient interface is shown with the headgear strap assembly removed. [Figure 8] Figure 7 is a front view of the patient interface. [Figure 9] This is a cross-sectional view taken through line 9-9 in Figure 8. [Figure 10]This is a cross-sectional view taken through line 10-10 in Figure 8. [Figure 11] This is an enlarged view of the cross-section shown in Figure 10. [Figure 12] This is a cross-sectional view taken through line 12-12 in Figure 8. [Figure 13] This is an enlarged view of the cross-section shown in Figure 12. [Figure 14] Figure 7 is a front view of the patient interface showing the airflow path of the ventilation section according to one embodiment of this technology. [Figure 15] Figure 7 is an exploded view of the patient interface as seen from the front. [Figure 16] Figure 7 shows another exploded view of the patient interface as seen from the front. [Figure 17] Figure 7 is an exploded view of the patient interface as seen from the rear. [Figure 18] Figure 7 is an exploded view of the patient interface as seen from below. [Figure 19] Figure 7 is a cross-sectional view of the main body of the patient interface frame assembly. [Figure 20] Figure 19 is a top view of the main body of the frame assembly shown. [Figure 21] Figure 19 is a front view of the main body of the frame assembly shown. [Figure 22] This is a magnified view of the main body of the frame assembly shown in Figure 21. [Figure 23] Figure 7 is a cross-sectional view of the cover of the patient interface frame assembly shown in Figure 7. [Figure 24] Figure 23 is a top view of the frame assembly cover. [Figure 25] Figure 7 is a perspective view of the cover of the patient interface cushion assembly shown in Figure 7. [Figure 26] Figure 25 shows another perspective view of the cushion assembly. [Figure 27] Figure 25 shows another perspective view of the cushion assembly. [Figure 28]Figure 25 is a top view of the cushion assembly shown. [Figure 29] This is a cross-sectional view taken through line 29-29 in Figure 28. [Figure 30] This is an enlarged view of the cross-section shown in Figure 29. [Figure 31] Figure 7 is a perspective view of the cover of the patient interface cushion assembly shown in Figure 7. [Figure 32] Figure 31 is a front view of the cushion assembly. [Figure 33] Figure 7 is a perspective view of the cover of the patient interface cushion assembly shown in Figure 7. [Figure 34] Figure 33 is another perspective view of the cushion assembly shown. [Figure 35] Figure 33 is a rear view of the cushion assembly shown. [Figure 36] Figure 33 is a side view of the cushion assembly shown. [Figure 37] Figure 33 is a bottom view of the cushion assembly. [Figure 38] This is a top view of a cushion assembly for a patient interface according to one embodiment of this technology. [Figure 39] Figure 38 is a side view of the cushion assembly. [Figure 40] This is a top view of a cushion assembly for a patient interface according to one embodiment of this technology. [Figure 41] Figure 40 is a side view of the cushion assembly. [Figure 42] This is a top view of a cushion assembly for a patient interface according to one embodiment of this technology. [Figure 43] Figure 42 is a side view of the cushion assembly. [Figure 44A] Figure 4 is a schematic perspective view showing a headgear strap assembly of a patient interface according to one embodiment of this technology. [Figure 44B] This is a cross-sectional view taken through line 44B-44B in Figure 44A. [Figure 45]Figure 4 is a top view of the headgear strap assembly of the patient interface according to one embodiment of this technology. [Figure 46] Figure 45 is an exploded view of the headgear strap assembly. [Figure 47] Figure 45 is a close-up view of the end of the strap portion of the headgear strap assembly. [Figure 48] Figure 45 is a perspective view of the buckle of the headgear strap assembly. [Figure 49] Figure 48 is a front view of the buckle. [Figure 50] Figure 48 is a top view of the buckle. [Figure 51] This is a cross-sectional view of the buckle shown in Figure 48. [Figure 52] This is an enlarged view of the cross-section shown in Figure 51. [Figure 53] This is a cross-sectional view showing strap adjustment of a headgear strap assembly according to an example of this technology. [Figure 54] This is a cross-sectional view showing strap adjustment of a headgear strap assembly according to an example of this technology. [Figure 55] This is a side view of a patient interface shown on a patient's head according to one embodiment of this technology, showing the patient interface with the patient headgear strap assembly in a first adjustment position. [Figure 56] This is a side view of a patient interface shown on a patient's head according to one embodiment of this technology, showing the patient interface with the patient headgear strap assembly in a second adjustment position. [Figure 57] This is a perspective view showing the cover of a patient interface frame assembly according to one embodiment of this technology. [Figure 58] This is a perspective view showing the main body of a patient interface frame assembly according to one embodiment of this technology. [Figure 59] This is a perspective view of a cushion assembly for a patient interface according to one embodiment of this technology. [Figure 60]This is a perspective view showing the main body of a patient interface frame assembly according to one embodiment of this technology. [Figure 61] This is a cross-sectional view showing the alignment function of the main body and cushion assembly of a patient interface frame assembly according to one embodiment of this technology. [Figure 62] This is a top view of a cushion assembly for a patient interface according to one embodiment of this technology. [Figure 63] Figure 62 is a bottom view of the cushion assembly. [Figure 64] Figure 62 is a perspective view of the cushion assembly. [Figure 65] Figure 62 is another perspective view of the cushion assembly. [Figure 66] Figure 62 is a cross-sectional view of the cushion assembly. [Figure 67] Figure 62 is another cross-sectional view of the cushion assembly. [Figure 68] This is a top view of a cushion assembly for a patient interface according to one embodiment of this technology. [Figure 69] Figure 68 is a bottom view of the cushion assembly. [Figure 70] Figure 68 is a perspective view of the cushion assembly. [Figure 71] Figure 68 shows another perspective view of the cushion assembly. [Figure 72] This is a perspective view of a cushion assembly for a patient interface according to one embodiment of this technology. [Figure 73] Figure 72 is a front view of the cushion assembly. [Figure 74] A perspective view showing the cushion assembly in Figure 72 connected to the main body of a frame assembly according to one embodiment of this technology. [Figure 75] Figure 74 is an exploded view of the main body and cushion assembly of the frame assembly shown. [Figure 76]This is a perspective view of a patient interface according to another embodiment of this technology, showing the patient interface with the headgear strap assembly removed. [Figure 77] Figure 76 is an exploded view of the patient interface as seen from the front. [Figure 78] Figure 76 is an exploded view of the patient interface as seen from the rear. [Figure 79] Figure 76 shows a perspective view of the patient interface frame assembly according to one embodiment of this technology. [Figure 80] Figure 79 is a front view of the frame assembly. [Figure 81] Figure 79 is a top view of the frame assembly. [Figure 82A] This is an enlarged view of the frame assembly shown in Figure 79. [Figure 82B] Figure 82A is a cross-sectional view of the frame assembly. [Figure 82C] Figure 79 is a cross-sectional view of the patient interface. [Figure 83A] These are various diagrams showing a patient interface attached according to one embodiment of this technology. [Figure 83B] These are various diagrams showing a patient interface attached according to one embodiment of this technology. [Figure 83C] These are various diagrams showing a patient interface attached according to one embodiment of this technology. [Figure 83D] These are various diagrams showing a patient interface attached according to one embodiment of this technology. [Figure 84A] These are various diagrams illustrating the adjustment of the headgear strap assembly of a patient interface according to one embodiment of this technology. [Figure 84B] These are various diagrams illustrating the adjustment of the headgear strap assembly of a patient interface according to one embodiment of this technology. [Figure 85] This figure shows the removal of the patient interface frame assembly according to one embodiment of this technology. [Figure 86A]These are various diagrams illustrating the adjustment of the patient interface buckle according to one embodiment of this technology. [Figure 86B] These are various diagrams illustrating the adjustment of the patient interface buckle according to one embodiment of this technology. [Modes for carrying out the invention]

[0105] 5. Detailed Description of Examples of the Technology Before describing the technology in further detail, it should be understood that the technology is not limited to the specific embodiments which may differ as described herein. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0106] The following description is provided in relation to a variety of embodiments that may share one or more common properties 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 any other embodiment. In addition, any single feature or combination of features in any of these embodiments may constitute a further embodiment.

[0107] 5.1 Treatment In one embodiment, the technology includes a method for treating respiratory diseases. The method includes the step of applying positive pressure to the airway entrance of 1000 patients.

[0108] In certain embodiments of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0109] In certain embodiments of this technology, mouth breathing is restricted, limited, or prevented.

[0110] 5.2 Treatment System In one embodiment, the 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 (see, for example, Figures 1A to 1C).

[0111] 5.3 Patient Interface Referring to Figures 4 to 18, a non-invasive patient interface 3000 according to one aspect of the present technology is shown. The non-invasive patient interface includes a frame assembly 3500, a cushion assembly 3075 including a seal-forming structure 3100, a frame connection structure 3150, and a positioning and stabilization structure 3300. In some embodiments, the functional mode may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional modes. When in use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airway to facilitate positive pressure air supply to the airway.

[0112] In the illustrated example, the frame assembly 3500 includes a vent 3400 and a connection port 3600 for connecting the air circuit 4170 to the short pipe 4180. The frame assembly 3500 also functions as a central hub to which the cushion assembly 3075, the positioning and stabilizing structure 3300, and the short pipe 4180 are connected, the connections being made, for example, in a removable manner or in a more permanent manner. The frame assembly 3500 is constructed such that sealing forces are transferred from the positioning and stabilizing structure 3300 to the cushion assembly 3075.

[0113] In one embodiment of this technology, the frame assembly 3500 and the cushion assembly 3075 are repeatedly and detachably engaged with each other (for example, to allow cleaning and / or replacement of the cushion assembly 3075). When the frame assembly 3500 and the cushion assembly 3075 are engaged, they form a plenum chamber 3200. The plenum chamber 3200 can receive a pressurized gas flow from the short tube 4180 of the air circuit 4170, which can then be moved into the patient's airway for inspiration through the seal-forming structure 3100.

[0114] If a patient interface cannot comfortably deliver the minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0115] A patient interface 3000 in one form of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 6 cmH2O relative to the surroundings.

[0116] A patient interface 3000 in one embodiment of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 10 cmH2O relative to the surroundings.

[0117] A patient interface 3000 in one form of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 20 cmH2O relative to the surroundings.

[0118] 5.3.1 Seal-forming structure In one embodiment of this technology, the seal-forming structure 3100 may provide a target seal-forming region and further provide a cushioning function. The target seal-forming region is the region in the seal-forming structure 3100 where sealing can occur. The region where sealing actually occurs (i.e., the actual sealed surface) may vary from patient to patient in a given treatment session, depending on a range of factors (e.g., the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face).

[0119] In one embodiment, the target seal formation region is located on the outer surface of the seal formation structure 3100.

[0120] In a specific embodiment of this technology, the seal-forming structure 3100 is made of a biocompatible material (e.g., silicone rubber).

[0121] The seal-forming structure 3100 produced by this technology may be made of a soft, flexible, and elastic material (e.g., silicone).

[0122] In certain embodiments of this technology, a system is provided comprising more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate different size and / or shape ranges. For example, the system may include one form of seal-forming structure 3100 suitable for large heads rather than small heads, and another suitable for small heads rather than large heads.

[0123] 5.3.1.1 Sealing mechanism In one embodiment, the seal-forming structure includes a sealing flange using a pressure-assisted sealing mechanism. During use, the sealing flange can readily respond to the positive system pressure within the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface. The pressure-assisted mechanism may work in conjunction with elastic tension in the positioning and stabilizing structure.

[0124] In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than approximately 1 mm (e.g., approximately 0.25 mm to approximately 0.45 mm). This member extends around the perimeter length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is positioned between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the perimeter length. The support flange is or includes a spring-like element and functions to support the sealing flange so as not to buckle during use.

[0125] In one embodiment, the seal-forming structure may include a compression sealing portion or a gasket sealing portion. During use, the compression sealing portion or gasket sealing portion is constructed and positioned such that it is compressed due, for example, elastic tension in the positioning and stabilizing structure.

[0126] In one embodiment, the seal-forming structure includes a tensioning portion. During use, the tensioning portion is held taut by, for example, an adjacent region of the sealing flange.

[0127] In one embodiment, the seal-forming structure includes a region having an adhesive surface or bonding surface.

[0128] In certain embodiments of this technology, the seal-forming structure may include one or more of the following: a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or bonding surface.

[0129] 5.3.1.2 Nasal bridge or nasal ridge region In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the nasal bridge region or nasal ridge region of the patient's face when in use.

[0130] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the nasal bridge region or nasal ridge region of the patient's face when in use.

[0131] 5.3.1.3 Upper lip area In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal when in use on the upper lip region (i.e., the upper lip) of the patient's face.

[0132] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the upper lip area of ​​the patient's face when in use.

[0133] 5.3.1.4 Jaw region In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the jaw region of the patient's face when in use.

[0134] In one embodiment, the seal-forming structure includes a saddle-shaped region constructed to form a seal on the jaw region of the patient's face when in use.

[0135] 5.3.1.5 Frontal area In one embodiment, the seal-forming structure forms a seal on the forehead area of ​​the patient's face when the seal is in use. In this embodiment, the plenum chamber can cover the eye when in use.

[0136] 5.3.1.6 Nasal pillow In one embodiment, 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 positioned to form a seal with each nostril of the patient's nose.

[0137] A nasal pillow according to one aspect of this technology includes a frustum of a cone. At least a portion of the frustum of the cone forms a seal on the underside of the patient's nose, on the stalk, and on a flexible region on the underside of the frustum of the cone, connecting the frustum of the cone to the stalk. In addition, the structure to which the nasal pillow of this technology is connected includes a flexible region adjacent to the base of the stalk. The flexible region may function to facilitate a flexible connection structure. The flexible connection structure accommodates both the displacement and angle of the frustum of the cone and the mutual movement between the nasal pillow and the structure to which it is connected. For example, the frustum of the cone may be displaced axially toward the structure to which the stalk is connected.

[0138] 5.3.1.7 Nose Cradle Figures 25 to 37 show a seal-forming structure 3100 according to an example of the present technology. In the illustrated embodiment, as can be seen, for example, from Figures 4, 55, and 56, the seal-forming structure 3100 can be considered a nasal cradle cushion and is intended to provide pressurized gas flow to the patient's nostrils by sealing at least the underside of the patient's nose. The exemplary seal-forming structure 3100 engages with the patient's face below the bridge of the nose and, in some examples, may engage with the patient's nose below the nasal tip, depending on the size and shape of the patient's nose. The exemplary seal-forming structure 3100 also engages with the patient's face above at least the upper lip. Therefore, the exemplary seal-forming structure 3100 can seal the patient's upper lip when in use. Furthermore, since the patient's mouth may remain exposed by the seal-forming structure 3100 of the described example, the patient may be able to breathe freely (i.e., breathe directly from the surroundings) (without interference from the seal-forming structure 3100).

[0139] An exemplary nasal cradle cushion may include an upper saddle-shaped or concave region with positive curvature across the cushion. Furthermore, in contrast to a nasal cradle cushion which may be understood as having a single target seal-forming region or surface, a pillow cushion may have two target seal-forming regions (one for each nostril). The cradle cushion may also have a posterior wall that contacts the patient's upper lip and an upper central surface that contacts the underside of the patient's nose. These two surfaces on the patient's face create a nasolabial angle between them (see Figure 2E). The cradle cushion may be shaped to have a nasolabial angle ranging from 90 to 120 degrees.

[0140] Furthermore, the exemplary seal-forming structure 3100 may be shaped and sized such that no part of the seal-forming structure 3100 enters the patient's nostril during use.

[0141] As best shown in Figures 33 to 37, the exemplary seal-forming structure 3100 may include at least two regions of different thicknesses (i.e., a lateral support region 3108 and an intermediate region 3114). In a further example, a third region (in addition to the lateral support region 3108 and the intermediate region 3114) may be provided, which is a positive lateral region 3110 of a different thickness. In a further example, there may be one or more additional regions of different thicknesses (in addition to the lateral support region 3108, the positive lateral region 3110, and the intermediate region 3114). As can be seen from the figures, different thicknesses can be generated by extending regions of different thicknesses and distances into the interior of the seal-forming structure 3100, thereby smoothing the outer surface of the seal-forming structure 3100. This outer surface may not be irregular in the transition regions between regions of different thicknesses. Thus, the exterior of the exemplary seal-forming structure 3100 is continuous and smooth.

[0142] In the illustrated example, the nasal openings 3102 may be formed through an intermediate region 3114. The nasal openings 3102 are positioned to generally align with the patient's corresponding nostrils so that a pressurized gas flow is provided to the patient's nostrils for inhalation and exhalation is returned to the seal-forming structure 3100 (for release into the atmosphere via the vent 3400). Within the intermediate region 3114, a bridge portion 3104 may be provided between the nasal openings 3102.

[0143] In one example, since these different examples of seal-forming structures 3100 differ in size and shape, each modified example may provide an optimal fit for patients with different nose and facial shapes and sizes.

[0144] In one example, the seal-forming structure 3100 may include two or more different sizes / shapes. For example, Figures 38-39 show an exemplary small seal-forming structure 3100, Figures 40-41 show an exemplary narrow-width seal-forming structure 3100, and Figures 42-43 show an exemplary medium-sized seal-forming structure 3100. As shown, the size dimensions and / or shape of the seal-forming structure may be modified to provide different seal-forming surfaces for different patients.

[0145] In one example, adding one or more thickened sections (e.g., silicone thickened sections) to one or more regions of the seal-forming structure 3100 provides support and stability in one or more regions (e.g., to ensure cushioning stability and sealing performance). In one example, one or more thickened sections may be created by increasing the thickness of the seal-forming structure 3100 in one or more regions within the seal-forming structure 3100, such that the outer surface of the seal-forming structure 3100 is kept continuous and smooth. The one or more thickened sections may include similar or different thicknesses to one another. In one example, the thickness of one or more thickened sections and / or the specific positioning of one or more thickened sections along the seal-forming structure 3100 may depend at least on the size of the seal-forming structure 3100.

[0146] For example, Figures 62 to 67 show an exemplary narrow-width seal-forming structure 3100 that includes a thickened portion 3120 along the upper side of the seal-forming structure 3100 (closer to the bridge of the nose) and a thickened portion 3121 along the lower side of the seal-forming structure 3100 (closer to the upper lip) (for example, thickened portions 3120 and 3121 provided along the lower side of the seal-forming structure 3100 in the intermediate region 3114 of the seal-forming structure 3100, near the frame connection structure 3150).

[0147] In contrast, Figures 68 to 71 show an exemplary medium-sized seal-forming structure 3100 that includes a thickened portion 3122 along the underside of the seal-forming structure 3100 (closer to the upper lip) (for example, a thickened portion 3122 provided along the underside of the seal-forming structure 3100 near the frame connection structure 3150 within each lateral support region 3108 of the seal-forming structure 3100). In this example, it is not necessary to add a thickened portion to the medium-sized seal-forming structure 3100 along the upper side of the seal-forming structure 3100 (closer to the bridge of the nose).

[0148] However, in other examples, it should be understood that the thickness and / or positioning of the thickened portion may be possible in one or more regions of the seal-forming structure 3100.

[0149] 5.3.2 Frame connection structure As shown in Figures 25 to 30, the frame connection structure 3150 is constructed and arranged to allow the cushion assembly 3075 to be removably and repeatedly connected to the frame assembly 3500 (for example, to facilitate cleaning, replacement, and / or modification for different cushion assemblies 3075 having different sized seal forming structures 3100 as described above in relation to Figures 38 to 43).

[0150] The frame connection structure 3150 includes a seal connection portion 3160 adapted for connection to a seal forming structure 3100 and a frame connection portion 3170 adapted for connection to a frame assembly 3500.

[0151] The frame connection structure 3150 may be permanent (e.g., overmolded) or it may be removablely connected to the seal forming structure 3100 (e.g., a press-fit assembly).

[0152] Overmolded structure In the illustrated example, the frame connection structure 3150 and the seal forming structure 3100 include an overmolded structure for forming a one-piece integrated component.

[0153] For example, the frame connection structure 3150 includes a first part or base mold, and the seal forming structure 3100 includes a second part or overmolding provided on the first part (for example, by an overmolding).

[0154] In one example, the frame connection structure 3150 includes a material with higher rigidity than the seal forming structure 3100. In one example, the frame connection structure 3150 and the seal forming structure 3100 may include similar materials (e.g., thermoplastic elastomer (TPE) or silicone), and since the frame connection structure 3150 has a higher durometer (e.g., a higher Shore A hardness) than the seal forming structure 3100, a dual-durometer component is obtained.

[0155] In one example, the cushion assembly 3075 may be formed by a two-shot continuous overmolding process in which different materials are injected into the same molding machine to form the cushion assembly 3075. For example, in a first step, the molding machine injects a first material into a closed cavity (i.e., a first shot) to form the frame connection structure 3150 (i.e., a first part or base mold) into shape. In a second step, the molding machine injects a second material into the remaining space of the closed cavity (i.e., a second shot) to form the seal forming structure 3100 (i.e., a second part or overmolde) into shape (as an overmolde onto the frame connection structure 3150). In one example, the frame connection structure 3150 may include an insert after the first shot, and the molding machine may move the mold core and / or insert (i.e., the frame connection structure 3150) to generate a second cavity for forming the seal-forming structure 3100 in a second shot.

[0156] In one example, the seal-forming structure 3100 may be overmolded onto the frame-connecting structure 3150 from a material capable of chemical bonding or self-adhesion to the material of the frame-connecting structure 3150. For example, as shown in Figure 30, the seal connection portion 3160 of the frame-connecting structure 3150 may include one or more interface surfaces 3615 (e.g., land areas) that are structured to bond with the seal-forming structure 3100. Such a bond can be made stronger by increasing the land area. In one example, the seal connection portion 3160 may provide a chemical bond without mechanical interlock. As a result, cracks are eliminated in the connection, an airtight seal is obtained, and the interface can be cleaned.

[0157] As a result, the entire cushion assembly 3075 may contain silicone material with varying hardness ranges. For example, the frame connection structure 3150 (i.e., the first shot or base mold) may contain a higher durometer silicone material (e.g., Shore A hardness above 60 Shore A (e.g., 65 Shore A, 60-70 Shore A, 60-90 Shore A, up to 70 Shore A, up to 90 Shore A)), and the seal forming structure 3100 (i.e., the second shot or overmold) may contain a lower durometer silicone material than the frame connection structure 3150 (e.g., Shore A hardness above 30 Shore A (e.g., 40 Shore A, 30-50 Shore A, less than 50 Shore A)).

[0158] In one example, the frame connection structure 3150 (i.e., the first shot or base mold) may contain a higher durometer LSR material, and the seal-forming structure 3100 (i.e., the second shot or overmolde) may contain a lower durometer LSR material. However, it should be understood that other suitable materials may be used.

[0159] The higher the durometer, the more rigid the material the frame connection structure 3150 is adapted to connect to the frame assembly 3500. As shown in the figure, the frame connection portion 3170 of the frame connection structure 3150 forms a curved end or undercut 3175 that functions as an interface or catch adapted to connect to the frame assembly 3500. By using silicone material and an overmolding process for forming the frame connection structure 3150, the curved end or undercut can be demolded, which allows the cushion assembly to have a smaller size and shape (e.g., smaller and easier to manufacture than when the seal is overmolded on a rigid plastic clip). Using a higher durometer silicone material for the frame connection structure 3150 also provides the advantage of greater robustness against physical impact from external forces (e.g., crush resistance in contrast to a rigid plastic clip) and reduces high manufacturing costs.

[0160] In the illustrated example, the frame connection structure 3150 is positioned along the inner or inner circumferential surface of the seal forming structure 3100, so that the frame connection structure 3150 is positioned or oriented toward the interior of the cushion assembly (i.e., the frame connection structure 3150 protrudes inward from the inner or inner circumferential surface of the seal forming structure 3100 toward the cavity of the seal forming structure 3100, forming at least a portion of the plenum chamber 3200). This positioning configuration allows the frame connection structure 3150 and its undercut 3175 to be extended on the frame assembly 3500 for mounting.

[0161] In one example, the frame connection structure 3150 and its undercut 3175 extend around the entire periphery or the entire inner surface of the seal-forming structure 3100. In another example, the frame connection structure 3150 and its undercut 3175 may extend along one or more selected portions around the seal-forming structure 3100 (for example, along a portion of the inner surface of the seal-forming structure 3100).

[0162] In one example, the frame connection structure 3150 may provide an outline that forms a smooth and continuous curve along the periphery of the cavity of the seal-forming structure 3100 (e.g., the frame connection structure 3150 that interlocks with the seal-forming structure 3100). In one example, the length of the frame connection structure 3150 protruding into the cavity may be the same along the entire periphery of the seal-forming structure 3100. In another example, it should be understood that the outline of the frame connection structure 3150 may differ along one or more parts around the seal-forming structure 3100. For example, the length of the frame connection structure 3150 may differ along one or more parts around the seal-forming structure 3100.

[0163] The lower the durometer, the more flexible and comfortable the material of the seal-forming structure 3100 is that is adapted to sealing the patient's face. In addition, the sealing lip 3850 is formed along the seal-forming structure 3100 of a lower durometer material. As described below, the sealing lip 3850 is positioned along the inner or inner circumferential surface of the seal-forming structure 3100 and is adapted to form a seal with the frame assembly 3500 (for example, when the pressure inside the plenum chamber 3200 increases), thereby increasing therapeutic effectiveness and patient satisfaction, for example, by preventing leakage.

[0164] In the illustrated example, the frame connection structure 3150 is provided along the cavity edge of the seal forming structure 3100, and the sealing lip 3850 is positioned inside the frame connection structure 3150 within the cavity. The frame connection structure 3150 and the sealing lip 3850 form a space between them to receive a portion of the frame assembly 3500 when the cushion assembly 3075 is attached to the frame assembly 3500, as described below.

[0165] In one example, the frame connection structure 3150 (i.e., the first shot or base mold) may have a similar or different color to the seal forming structure 3100 (i.e., the second shot or over mold), for example, both the frame connection structure 3150 and the seal forming structure 3100 may have a transparent or generally transparent color.

[0166] In one example, the frame connection structure 3150 (i.e., the first shot or base mold) may include a surface finish similar to or different from that of the seal forming structure 3100 (i.e., the second shot or overmolding), for example, the frame connection structure 3150 may include a highly polished surface finish, and the seal forming structure 3100 may include a textured surface finish.

[0167] Figures 31 and 32 are further diagrams of the cushion assembly 3075, illustrating the difference between the frame connection structure 3150 and the seal forming structure 3100 according to an example of the present technology.

[0168] 5.3.3 Frame Assembly As best shown in Figures 15 to 24, the frame assembly 3500 includes a main body 3510 and a cover 3580 provided on the front side of the main body 3510.

[0169] In one example, the main body 3510 and the cover 3580 may be constructed (e.g., molded) from a relatively rigid material (e.g., polypropylene, polycarbonate).

[0170] The main body 3510 includes a body portion 3520, a cushion connection portion 3530, and a cover connection portion 3540. Furthermore, as will be described in more detail below, the main body 3510 and the cover 3580 cooperate to form a ventilation portion 3400 and maintain a radiating member 3450 (for example, a filter material for the ventilation portion 3400) within the frame assembly 3500.

[0171] In the illustrated example, each of the pair of rigidizer arms 3302 of the positioning and stabilizing structure 3300 is connected to each side of the main body 3510 by each of the pair of flexible joints 3305. In one example, the flexible joints 3305 may be permanently connected to the main body 3510 and may be permanently connected to each rigidizer arm 3302 (for example, via an overmolded interference fit assembly). However, the rigidizer arms 3302 may be connected to the main body 3510 in other suitable manner.

[0172] The cover 3580 includes a front wall portion 3585 and a tubular portion 3590. The tubular portion 3590 includes a connection port 3600 for connecting the air circuit 4170 to a short pipe 4180. In one example, the cover 3580 may also be called a pipe connector.

[0173] In the illustrated example, the short pipe 4180 may be directly connected to the connection port 3600, or it may be connected to the connection port 3600 (without using an elbow or swivel elbow). For example, the short pipe 4180 may be directly connected to the front of the tubular section 3590 of the cover 3580. The short pipe 4180 may be permanently or removablely connected to the connection port 3600. Permanent connections may be made by overmolding or a compression fit assembly. In another example, the short pipe 4180 may be connected to the connection port 3600 via an elbow or swivel elbow. In yet another example, the air circuit 4170 may be connected to the connection port 3600 (for example, directly or via an elbow) without using the short pipe 4180.

[0174] In the illustrated example, a surface with an outer shape that conforms to the front of the tube portion 3590 is provided on the front side of the front wall portion 3585 (for example, for aesthetic reasons on the front wall portion), and the front side of the tube portion 3590 provides the front side of the patient interface 3000.

[0175] In the illustrated example, the rear of the tube section 3590 protrudes from the rear of the front wall section 3585. The cover connector 3540 of the body 3510 takes the shape of a tube adapted to receive the rear of the tube section 3590 (e.g., in a nested manner) for alignment and connection between the cover 3580 and the body 3510. As shown, the tube section 3590 and the cover connector 3540 include a snap or interlocking assembly. For example, on the rear of the tube section 3590, a peripheral groove 3595 is provided, adapted to engage with a peripheral bead 3545 along the interior of the cover connector 3540 (see, for example, Figure 13). However, it should be understood that the connection of the cover 3580 to the body 3510 may be in other suitable manner (e.g., in a removable or more permanent manner).

[0176] In the illustrated example, the rear side of the front wall portion 3585 provides a stop portion to prevent the pipe portion 3590 from being excessively inserted into the cover connection portion 3540 of the main body 3510. In another example, in the recessed area 3550 on the front side of the main body 3510, a step 3562 can be obtained in which a plurality of ribs 3560 are provided along the periphery forming part of the ventilation portion 3400, and such ribs 3560 are structured and arranged to provide a stop portion on the outer edge of the front wall portion 3585. Such a stop portion maintains a space between the front wall portion 3585 and the sides and bottom of the recessed area 3550 (which forms the ventilating portion of the ventilation portion 3400 including the ventilating member 3450), as will be described in more detail below.

[0177] In one example, the cover 3580 and the body 3510 may each include alignment features to ensure that the cover 3580 and the body 3510 are precisely aligned or oriented for assembly. For example, as best shown in Figures 57 and 58, the cover 3580 may include a projection 3581 (e.g., a male alignment feature) adapted to receive a corresponding recess 3511 (e.g., a female alignment feature) in the body 3510. However, other suitable alignment features are possible.

[0178] In one example, the curvature of the frame assembly 3500 (see, for example, the front wall portion of the main body 3510 and cover 3580) (as viewed from above, as shown in Figures 20 and 24) is intended to follow the inherent curvature of the patient's upper lip, thereby avoiding the concentration of contact pressure on any particular point on the patient's upper lip, and thus the contact pressure from the headgear tension is evenly distributed over the patient's upper lip to minimize or eliminate, for example, skin breakdown caused by prolonged concentration of contact pressure. Another advantage of this curvature is that it requires less material, leading to a reduction in the overall weight of the patient interface 3000. The curvature also minimizes any protrusions of the patient interface 3000 in the forward direction from the patient's face, thus improving the inconspicuousness of the patient interface 3000.

[0179] For example, the frame assembly 3500 may be manufactured in one size, while the cushion assembly 3075 may be manufactured in multiple sizes that can be attached to a single frame assembly 3500 by common-size connecting features. For example, cushion sizes may include different-sized seal-forming structures using common-size frame connecting structures for attachment to a common frame assembly 3500.

[0180] 5.3.4 Connection between the cushion assembly and the frame assembly In the illustrated example, the frame connection portion 3170 of cushion assembly 3075 and the cushion connection portion 3530 of frame assembly 3500 include interference fit assemblies.

[0181] For example, the frame connector 3170 of the cushion assembly 3075 forms a curved end or undercut 3175, and the cushion connector 3530 of the frame assembly 3500 includes a channel with an undercut 3535 along the rear wall of the channel. As shown in Figure 13, the curved end or undercut 3175 of the frame connector 3170 is constructed and positioned to engage with the rear side of the undercut 3535 of the cushion connector 3530 so as to cover it, thereby allowing the cushion assembly 3075 to be removably connected to the frame assembly 3500. In one example, the curved end of the frame connector 3170 and the channel of the frame assembly 3500 form a tongue-and-groove arrangement configuration so that the cushion assembly 3075 can be removably and repeatedly connected to the frame assembly 3500.

[0182] In one example, since the cushion assembly 3075 is made of a relatively flexible material, the frame connection structure 3150 and its frame connection 3170 can extend on the cushion connection 3530 until the curved end or undercut 3175 of the frame connection 3170 can capture or interface with the undercut 3535 of the cushion connection 3530. For example, the relatively flexible ring formed by the frame connection structure 3150 can extend on a relatively rigid frame assembly 3500 for mounting.

[0183] As shown in Figure 30, the frame connection portion 3170 of the frame connection structure 3150 may be provided with a tapered or angled end face 3171 to guide and promote outward deflection of the frame connection portion 3170 so as to cover the rear side of the cushion connection portion 3530 of the frame assembly 3500. For example, the tapered or angled end face 3171 may be adapted to engage with the cushion connection portion 3530 of the frame assembly 3500 to facilitate assembly.

[0184] In one example, the higher the durometer, the more the frame connection structure 3150 may be or function as a “cushion clip” structured and arranged to removably and repeatedly clip the cushion assembly 3075 to the frame assembly 3500. For example, the increased hardness made possible by the higher durometer material of the frame connection structure 3150 may allow it to function as a clip structure structured to reduce deformation of the frame connection structure 3150, thereby enabling the frame connection structure 3150 to maintain engagement between the cushion assembly 3075 and the frame assembly 3500 and preventing the cushion assembly 3075 from coming off the frame assembly 3500.

[0185] Disconnection of the cushion assembly 3075 and the frame assembly 3500 can be performed by applying sufficient force to extend the frame connection structure 3150 of the cushion assembly 3075 and detach it from the channel (to relieve or remove the undercut 3535 of the cushion connection portion 3530 of the frame assembly 3500).

[0186] Sealing lip As described above, the sealing lip 3850 is formed along the seal-forming structure 3100 of a lower durometer material. As best shown in Figures 29 to 30, the sealing lip 3850 takes the form of a flexible flap positioned along the inner surface or inner circumferential surface of the seal-forming structure 3100. The sealing lip 3850 protrudes into the cavity of the seal-forming structure 3100, which forms at least a portion of the plenum chamber 3200.

[0187] In one example, as shown in FIG. 13, the sealing lip 3850 is structured and arranged to form a pneumatic seal with the cushion connection portion 3530 (e.g., the rear wall of the channel) of the frame assembly 3500 by engaging with the frame assembly 3500. In one example, the sealing lip 3850 can be structured and arranged to engage with the frame assembly 3500 when the cushion assembly 3075 is initially connected to the frame assembly 3500. For example, the sealing lip 3850 is arranged to flex by interference against the cushion connection portion 3530 of the frame assembly 3500. When the pressure in the plenum chamber 3200 is increased beyond atmospheric pressure for sleep disorder treatment, the pneumatic seal is strengthened, and as the force applied to the frame assembly 3500 increases and biases the sealing lip 3850, the sealing force increases.

[0188] In another example, the sealing lip 3850 may be spaced from or adjacent to the frame assembly 3500 when the cushion assembly 3075 is initially connected to the frame assembly 3500, and when the pressure in the plenum chamber 3200 increases, a seal with the frame assembly 3500 is formed by the sealing lip 3850.

[0189] The sealing lip 3850 is sufficiently long so that (when the frame connection structure 3150 of the cushion assembly 3075 extends onto the cushion connection portion 3530 of the frame assembly 3500 during assembly) the sealing lip 3850 is not caught or trapped within the frame assembly 3500.

[0190] In one example, the length of the sealing lip 3850 can be the same along the entire perimeter of the seal formation structure 3100. In another example, the length of the sealing lip 3850 can be different along one or more portions of the perimeter of the seal formation structure 3100.

[0191] For example, as shown in the examples of FIGS. 72 and 73, by making the sealing lip 3850 longer than the two lateral ends or sides of the seal forming structure 3100, when the cushion assembly 3075 is assembled onto the frame assembly 3500, a situation where the sealing lip 3850 is caught or confined when the cushion assembly 3075 is laterally extended and released is avoided. This configuration is best shown in FIG. 73. FIG. 73 shows that the portion of the sealing lip 3850 at the two lateral ends or sides of the seal forming structure 3100 is longer than the portions of the sealing lip 3850 at the upper (above) and lower (below) sides of the seal forming structure 3100 (i.e., it protrudes further into the cavity of the seal forming structure 3100).

[0192] Furthermore, the curvature of the sealing lip 3850 can vary along one or more portions of the periphery of the seal forming structure 3100. For example, as best shown in FIG. 72, the longer sealing lip 3850 at the two lateral ends or sides of the seal forming structure 3100 can also include a curvature such that the sealing lip 3850 at the two lateral ends or sides of the seal forming structure 3100 protrudes or is curved further away from the frame connection structure 3150 (than the portions of the sealing lip 3850 at the upper (above) and lower (below) sides of the seal forming structure 3100). Such an arrangement can also make it possible to facilitate the assembly of the cushion assembly 3075 onto the lateral ends of the frame assembly 3500 without the sealing lip 3850 being caught or confined. For example, since sufficient space is obtained between the frame connection structure 3150 and the sealing lip 3850, it becomes possible to connect the frame connection structure 3150 without the sealing lip 3850 being confined within the frame assembly 3500 during assembly.

[0193] Alignment feature In one example, the patient interface 3000 may include visual and / or tactile indicators to avoid or minimize mis-orientation and improper assembly / disassembly. This can ensure proper assembly / disassembly, avoid unintended damage to the patient interface 3000, and mitigate any user frustration associated with assembly / disassembly.

[0194] In one example, the cushion assembly 3075 and the frame assembly 3500 may each include alignment features to ensure that the cushion assembly 3075 and the frame assembly 3500 are accurately aligned or oriented during assembly.

[0195] For example, as best shown in Figures 16 to 18, the cushion connection portion 3530 of the frame assembly 3500 may include one or more protrusions 3537 (e.g., male alignment features) within the channel. These protrusions 3537 are adapted to receive one of one or more recesses 3177 (e.g., female alignment features) along the frame connection portion 3170 of the cushion assembly 3075. As shown, the protrusions 3537 / recesses 3177 are provided only on one side (e.g., the upper side) of the frame assembly 3500 / cushion assembly 3500 to ensure proper orientation of the cushion assembly 3075 when connected to the frame assembly 3500.

[0196] In another example, as shown in Figures 59 to 61, the cushion connection portion 3530 of the frame assembly 3500 may include a single projection 3537 on the lateral side of the frame assembly 3500, which is adapted to receive a corresponding recess 3177 along the lateral side of the frame connection portion 3170 of the cushion assembly 3075.

[0197] In another example, as shown in Figures 72 to 75, the cushion connection portion 3530 of the frame assembly 3500 may include a single projection 3577 on the upper center of the frame assembly 3500, which is adapted to receive a corresponding notch 3179 along the upper center of the cushion assembly 3075.

[0198] In the examples in Figures 16-18 and 59-61, the recess(s) 3177 are located on the inside of the frame connection structure 3150. In the examples in Figures 72-75, the notch 3179 includes a complete cut-through around the frame connection structure 3150, so a separate recess is located on the edge of the cushion assembly 3075. In contrast to the examples in Figures 16-18 and 59-61, the notch configuration and its position on the upper center of the cushion assembly 3075 in Figures 72-75 provide a clearer visual indication for the patient, making it easier to align the cushion assembly 3075 to the frame assembly 3500.

[0199] It should be understood that alignment features may include different shapes and locations. For example, alignment features may be provided along any one or more locations around the cushion assembly and frame assembly, and alignment features may include any suitable shape (e.g., an internal or external notch or recess of the frame connection structure 3150). Furthermore, it should be understood that any suitable number of alignment features may be provided (e.g., any suitable number of notches and / or recesses), and alternative examples of alignment features may be combined with each other (see, for example, Figure 75, which includes a frame assembly 3500 in which both projections 3577 and 3537 are adapted to receive internal notches 3179 and recesses 3177 (not shown) of the frame connection structure 3150). In each example, the alignment features are positioned to reduce misalignment and incorrect assembly of the cushion assembly 3075 to the frame assembly 3500. In one example, assembly may be avoided unless the alignment features of the cushion assembly 3075 and the frame assembly 3500 are aligned with each other.

[0200] 5.3.5 Plenum Chamber The plenum chamber 3200 has edges that are shaped to complement the surface contour of an average human face in the area where a seal is formed during use. During use, the peripheral edges of the plenum chamber 3200 are positioned close to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire edge of the plenum chamber 3200 during use. In some embodiments, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material.

[0201] In some forms of this technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized space defined by the plenum chamber. In such forms, the pressure is often reduced and / or the wearer's comfort is increased, which can improve treatment compliance.

[0202] In certain forms of this technology, the plenum chamber 3200 is constructed from a transparent material (e.g., transparent polycarbonate). The use of transparent materials can reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of transparent materials may also help clinicians confirm the placement and function of the patient interface.

[0203] In a specific form of this technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the intrusiveness of the patient interface, thereby helping to improve compliance with treatment.

[0204] 5.3.6 Positioning and stabilization structure The seal-forming structure 3100 of the patient interface 3000 of this technology can be held in a sealed position by the positioning and stabilizing structure 3300 during use.

[0205] In one embodiment, the positioning and stabilizing structure 3300 provides at least sufficient holding force to overcome the effect of positive pressure in the plenum chamber 3200 that causes the face to lift away from the face.

[0206] In one embodiment, the positioning and stabilizing structure 3300 provides sufficient holding force to overcome the attractive force on the patient interface 3000.

[0207] In one form, the positioning and stabilization structure 3300 provides a holding force as a safety margin to eliminate the possibility of a destructive action on the patient interface 3000 (e.g., caused by tubing rubbing or accidental interference with the patient interface).

[0208] 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 an unobtrusive outer shape or cross-sectional thickness 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.

[0209] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured not to be overly large or bulky so as not to interfere with a patient lying in a supine sleep position with the patient's head resting on the back region of the head.

[0210] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured not to be overly large or bulky so as not to interfere with a patient lying in a lateral sleep position with the patient's head resting on the side region of the head.

[0211] In one form of the present technology, the positioning and stabilization structure 3300 includes a decoupling site disposed between a front portion of the positioning and stabilization structure 3300 and a rear portion of the positioning and stabilization structure 3300. This decoupling site is not resistant to compression and can be, for example, a flexible or flimsy strap. The decoupling site is constructed and arranged so that when the patient lies with the head on the pillow, the presence of the decoupling site can avoid a situation where the force to the rear portion is transmitted along the positioning and stabilization structure 3300 and the seal is obstructed.

[0212] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap composed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam material is porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the fabric outer layer includes a loop material that engages with a hook material portion.

[0213] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., extendable with elasticity) strap. For example, the strap may be configured to be taut when in use, directing the force that brings the seal-forming structure into contact with a portion of the patient's face. In one embodiment, the strap may be configured as a tie.

[0214] In one embodiment of this technology, the positioning and stabilizing structure includes a first tie, which is constructed and positioned such that, during use, at least a portion of its lower edge passes over the patient's head to the superior base of the ear and covers a portion of the parietal bone without covering the occipital bone.

[0215] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a second tie. The second tie is constructed and positioned such that, when in use, at least a portion of its upper edge passes below the inferior foot of the patient's head and covers or rests on the occipital bone of the patient's head.

[0216] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a third tie constructed and positioned to interconnect the first tie and the second tie to reduce the tendency of the first tie and the second tie to move apart in different directions.

[0217] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. An advantage of this embodiment is that the strap is more comfortable when the patient lies down while sleeping.

[0218] In a particular embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap configured to be breathable, allowing water vapor to pass through its interior.

[0219] In certain embodiments of this technology, a system is provided comprising more than one positioning and stabilizing structure 3300. Each positioning and stabilizing structure is configured to provide holding force to accommodate different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for a large head rather than a small head, and for another small head rather than a large head.

[0220] An example of a positioning and stabilization structure 3300 according to the present technology is illustrated with reference to Figures 4 to 7 and 44 to 56. In the illustrated example, the positioning and stabilization structure 3300 includes a pair of rigidizer arms 3302 and a headgear strap assembly 3330 provided on the pair of rigidizer arms 3302. The rigidizer arms 3302 and the headgear strap assembly 3330 work together to hold the patient interface 3000 of the present technology in a sealed position when in use. For example, the rigidizer arms 3302 direct the tension vector generated by the headgear strap assembly 3330 so that the seal-forming structure 3100 is sealed to the base of the patient's nose.

[0221] As described above, each pair of rigidizer arms 3302 is connected to each side of the main body 3510 of the frame assembly 3500 by each pair of flexible joints 3305. However, the rigidizer arms 3302 may be connected to the main body 3510 in other suitable manner.

[0222] In the illustrated example, the headgear strap assembly 3330 includes a pair of straps 3340 and 3350 (each, for example, constructed of an elastic fabric). These straps 3340 and 3350 are connected to each other by an adjustment mechanism (e.g., a buckle 3360), allowing for length adjustments in addition to those made possible by the elasticity of the straps 3340 and 3350, as described below.

[0223] As shown in the figure, the pair of straps includes a first longer strap 3340 and a second shorter strap 3350, wherein the first strap 3340 is longer than the original length of the second strap 3350 (when it is in a neutral, unextended state).

[0224] Each strap 3340, 3350 may be made of an elastic material and may be elastic. In other words, each strap may elastically stretch to increase its length by an tensile force applied, for example, by a patient, and when this tensile force is released, it may return to its original length in a neutral state or contract. Each strap may be made of or contain any elastomer material such as elastane, TPE, or silicone. The material of each strap may also represent a combination of any of the above materials with other materials. Each strap may be a single-layer or multi-layer strap. Each strap may be knitted, knitted, braided, molded, extruded, or formed by other means. Each strap may contain or be made of a woven material such as a woven fabric. On the other hand, such a material may contain artificial or natural fibers, thereby providing desired useful surface properties (e.g., tactile properties and skin comfort). On the other hand, the material of each strap may contain an elastomer material that provides desired elastomer properties. In the illustrated example, each strap is stretchable. This allows for extension of the overall length of each strap, resulting in a comfortable force displacement profile.

[0225] The first strap 3340 includes a side strap portion 3342 and a back strap portion 3344. As shown in the figure, the back strap portion 3344 includes a dividing region. This dividing region divides the back strap portion 3344 into two back strap portions 3344a and 3344b. That is, the side strap portion 3342 branches into two back strap portions 3344a and 3344b. The second strap 3350 includes a side strap portion 3352.

[0226] In the illustrated example, one end of the side strap portion 3352 is connected to the buckle 3360 in an immovable manner, while the two back strap portions 3344a and 3344b of the back strap portion 3344 are either wound around the buckle 3360 or threaded to be adjustable relative to the buckle 3360.

[0227] The insertion of the rigidizer arms 3302 stiffens the headgear strap assembly 3330 in certain areas (for example, from the frame assembly 3500 to a location near the patient's cheekbone). Each strap 3340 and 3350 of the headgear strap assembly 3330 may take the form of a hollow ribbon structured to receive each of the rigidizer arms 3302 internally. Each strap may be considered to be threaded on each of the rigidizer arms 3302 (as it slips onto each rigidizer arm 3302) and fixed at one end of each rigidizer arm 3302 near the frame assembly 3500.

[0228] In the illustrated example, as can be seen from the schematic diagram in Figure 44A showing an elliptical or circular shape, or from the exemplary cross-sectional view in Figure 44B, each strap 3340 and 3350 has a tubular configuration. However, it is understood that the positioning and stabilizing structure 3300 may take any other shape (e.g., a flat or sheet-like shape, a single structure, a multi-layered structure, or a laminated structure).

[0229] The side strap portions 3342 and 3352 of each strap 3340 and 3350 include buttonholes 3343 and 3353 (e.g., slit-shaped configurations). The buttonholes 3343 and 3353 may be provided on the outer surface of each strap 3340 and 3350 (i.e., the surface facing away from the patient when worn) and are adapted to receive each rigidizer arm 3302 for insertion into or removal from the tubular or sleeve-shaped strap 3340 and 3350. Alternatively, the buttonholes 3343 and 3353 may be located on the inner surface of each strap 3340 and 3350. In one example, each side strap portion 3342 and 3352 may include a bagged end adapted to receive the end of each neighboring rigidizer arm 3302 of the frame assembly 3500.

[0230] In the illustration, reinforcing sections or finger tabs 3345 and 3347 are provided at each end of the first strap 3340, and a reinforcing section or finger tab 3355 is provided at the end of the second strap 3350 opposite the buckle 3360. In one example, each reinforcing section or finger tab 3345, 3347 and 3355 is made of a different material (e.g., TPE material) than the straps 3340 and 3350. In one example, each reinforcing section or finger tab 3345, 3347 and 3355 may be overmolded onto the ends of the straps 3340 and 3350, but each reinforcing section or finger tab 3345, 3347 and 3355 may be connected to the straps in other suitable manner.

[0231] Each reinforcement or finger tab 3345, 3347, and 3355 provides reinforcement to each end of straps 3340 and 3350 (for example, to avoid or reduce the possibility of the patient tearing or ripping the straps 3340 and 3350). Furthermore, the reinforcements or finger tabs 3345 and 3355 may also help provide visual and tactile notifications to the patient about how to slip straps 3340 and 3350 onto each rigidizer arm 3302 or remove straps 3340 and 3350 from each rigidizer arm 3302, and may also help locate the buttonholes 3343 and 3353. Furthermore, to prevent the strap 3340 from becoming detached from the buckle 3360, the two backstrap sections 3344a and 3344b are wound around or threaded through the buckle 3360, after which the reinforcement or finger tab 3347 is provided at the ends of the two backstrap sections 3344a and 3344b (for example, by overmolding). In addition, the reinforcement or finger tab 3347 provides visual and tactile guidance for adjusting the backstrap section 3344 relative to the buckle 3360.

[0232] As shown in Figures 4, 55, and 56, the side strap portions 3342 and 3352 of each strap 3340 and 3350 are fitted to extend along the sides of the patient's head when worn, while the back strap portion 3344 of strap 3340 is fitted to extend along the back of the patient's head.

[0233] To extend the headgear strap assembly 3330 during use, the length of the headgear strap assembly 3330 may be less than the average small head circumference of a patient. For example, the length of the headgear strap assembly 3330 (for example, the length of the headgear assembly when the back strap portion 3340 is fully retracted from the buckle 3360 as shown in Figure 45) may be less than 600 mm in one example and less than 500 mm in another. However, depending on the patient's sex, different lengths of headgear strap assemblies 3330 may be provided to the patient.

[0234] In the illustrated example, straps 3340 and 3350 are joined by a buckle 3360 (which allows for length adjustment made possible by the elasticity of straps 3340 and 3350 and additional length adjustment). As shown, the buckle 3360 includes a body 3362 together with a first end 3364 and a second end 3366. In the illustrated example, the first end 3364 is curved or angled upward relative to the second end 3366. The second end 3366 is connected to the end of strap 3350, for example, via overmolding. The body 3362 includes openings for receiving back strap portions 3344a and 3344b (i.e., a first opening 3370 configured to receive both back strap portions 3344a and 3344b, and a pair of second openings 3372a and 3372b configured for back strap portions 3344a and 3344b, respectively). Crossbar 3380 borders the first opening 3370 from the second openings 3372a and 3372b, and crossbar 3382 borders opening 3372a from opening 3372b.

[0235] As shown in the figure, the backstrap portions 3344a and 3344b are threaded upward around the crossbar 3380 through the first opening 3370 and threaded downward through the second openings 3372a and 3372b, respectively. The second openings 3372a and 3372b each include an angled edge or surface 3375 positioned to withstand adjustment during use.

[0236] In one example, the buckle 3360 comprises a relatively rigid material (e.g., polypropylene, polyethylene) and an overmolding (e.g., one comprising TPE material). For example, in the exemplary cross-sectional views of the buckle 3360 in Figures 51 and 52, the buckle 3360 comprises a relatively rigid base 3390 (e.g., polypropylene, polyethylene with a more flexible overmolding 3391 (e.g., TPE)). In the illustrated example, the overmolding 3391 is not provided along the openings 3370, 3372a and 3372b. In one example, one or more portions may be polished (e.g., areas surrounding the openings 3370, 3372a and 3372b, as shown in the shaded area in Figure 50) for purposes such as friction reduction and to facilitate the sliding or adjustment of the backstrap portions 3344a and 3344b relative to the buckle 3360. However, other suitable materials are also possible.

[0237] Figures 53 to 56 are illustrative diagrams showing strap adjustment of the headgear strap assembly 3330 according to an example of this technology. The headgear strap assembly 3330 enables high-precision tension adjustment, thus ensuring improved sealing of the cushion assembly 3075, especially after repeated use and / or washing of the headgear strap assembly 3330 (which can lead to loss of elasticity of the straps). Appropriate tension application from the headgear strap assembly 3330 may be particularly important in the nose cradle type seal forming structure 3100 of this technology compared to, for example, a pillow type seal forming structure where the tension required for sealing is low.

[0238] An adjustment mechanism (e.g., buckle 3360) can be operated to allow the patient to adjust the (effective) length of the elastic straps 3340 and 3350 (to maintain the required stretch and fit over time). For example, the elastic straps 3340 and 3350 may be joined by buckle 3360 in a first adjustment position (e.g., with the back strap portion 3340 substantially retracted from buckle 3360 as shown in Figures 45 and 55), or may be joined by buckle 3360 in one or more second adjustment positions (e.g., with the back strap portion 3340 overlapping to a different range than the first adjustment position as shown in Figure 56). At each adjustment position, the headgear strap assembly 3330 may include (1) a neutral or unextended state in which the headgear strap assembly 3330 includes a neutral or unextended length (i.e., a state in which no stretching force is applied to the elastic straps 3340 and 3350 to elastically stretch them), and (2) one or more extended or extended states in which the headgear strap assembly 3330 includes one or more extended or extended lengths (i.e., a state in which stretching force is applied to the elastic straps 3340 and 3350 to elastically stretch and increase the length of the straps 3340 and 3350). At each adjustment position, the material of the straps 3340 and 3350 limits the extended or extended length at the extended position to a certain range (i.e., the maximum length or effective length of the headgear strap assembly 3330 at each adjustment position). When the elastic strap 3340 is adjusted relative to the buckle 3360 (for example, from a first adjustment position to a second adjustment position), the neutral or non-extended length of the headgear strap assembly 3330 changes (for example, the length shortens when adjusted from the first adjustment position to the second adjustment position). When the length shortens in the neutral or non-extended state in this way, the extended length or extended length also shortens (for example, the maximum or effective length of the headgear strap assembly 3330 at the second adjustment position shortens). This configuration allows for adjustment of the maximum length or effective extendable length (for example, to accommodate the loss of strap elasticity in order to maintain a comfortable force displacement shape).Therefore, the elasticity of straps 3340 and 3350 provides an adjustment mechanism that allows length adjustment at a given adjustment position, and buckle 3360 provides a further adjustment mechanism that allows length adjustment beyond the range of length adjustment made possible by the elasticity of straps 3340 and 3350.

[0239] As shown in Figure 53, when the buckle extends generally parallel to the back strap portions 3344a and 3344b, the buckle 3360 is in the locked position and can withstand accidental adjustments caused by friction between the back strap portions 3344a and 3344b, the free ends of the back strap portions 3344a and 3344b, and the angled edges or surfaces 3375 of the second openings 3372a and 3372b. As shown in Figure 54, the buckle 3360 can be raised or swung to the unlocked position, so when the buckle extends across the back strap portions 3344a and 3344b, it becomes adjustable due to reduced friction between the back strap portions 3344a and 3344b, the free ends of the back strap portions 3344a and 3344b, and the angled edges or surfaces 3375 of the second openings 3372a and 3372b. In other words, in the unlocked position, the buckle 3360 is angled so that the back strap portions 3344a and 3344b slide relative to the buckle 3360 for length adjustment. This configuration is achieved by multiple forward and backward bends of the back strap portions 3344a and 3344b that surround the crossbar 3380 within the buckle 3360 (e.g., the operating principle of the capstan effect).

[0240] This configuration provides a simple and user-friendly buckle adjustment mechanism for the patient (especially when the patient interface is worn by the patient). In one example, such an adjustment configuration may be performed with one hand and may include a one-step adjustment (for example, the buckle 3360 can be tightened and swung by simply pulling the free ends of the back strap portions 3344a and 3344b relative to the buckle 3360 (e.g., via the reinforcement portion or finger tab 3347) and the buckle 3360 can be pulled out relative to the back strap portions 3344a and 3344b to loosen it).

[0241] Figure 55 is a side view of a patient interface shown on a patient's head according to one embodiment of the present technology, showing the patient interface in a first adjustment position, for example, a looser position. Figure 56 is a side view of a patient interface shown on a patient's head according to one embodiment of the present technology, showing the patient interface in a second adjustment position, for example, a tighter position.

[0242] Figures 83A to 86B show various diagrams illustrating the attachment, adjustment, and removal of the patient interface 3000 according to one embodiment of this technology.

[0243] For example, in Figure 83A, the patient begins wearing the patient interface 3000 by holding the patient interface 3000 away from the patient's nose so that the positioning and stabilizing structure 3300 is reliably curved upward or oriented. This facilitates the orientation and engagement of the seal-forming structure 3100 with respect to the patient's nose, and facilitates the orientation and engagement of the positioning and stabilizing structure 3300 on the patient's head.

[0244] Figure 83B shows how the patient positions the cushion assembly 3075 and its seal-forming structure 3100 below the patient's nose, ensuring that it is comfortably positioned against the patient's face. This figure also shows how the patient begins to wear the positioning and stabilizing structure 3300 (i.e., by holding the frame assembly 3500 / cushion assembly 3075 with one hand and pulling out the lower part of the back strap portion 3344a with the other hand, thereby extending the headgear strap assembly 3330 over the patient's head). Figures 83C and 83D show how the headgear strap assembly 3330 is extended around the back of the patient's head to hold the patient interface 3000 against the patient's nose (for example, by comfortably positioning the upper part of the back strap portion 3344b over the patient's head).

[0245] As shown in the illustration, one of the split backstrap sections 3344b is positioned above the patient's occipital lobe and the other of the split backstrap section 3344a is positioned below the patient's occipital lobe, for example, to provide cup-shaped support for the back of the patient's head for support and stability. However, it should be understood that the backstrap sections 3344a and 3344b may be positioned at different locations along the back of the patient's head (for example, to adjust tension or position for the patient's preference and / or comfort). For example, as shown in Figures 55 and 56, both backstrap sections 3344a and 3344b may be positioned higher above the patient's head and closer to each other (for example, both generally above the patient's occipital lobe). Figures 84A and 84B are illustrative diagrams showing the adjustment of the divided back straps 3344a and 3344b to achieve a comfortable fit (for example, by adjusting the divided back straps 3344a and 3344b by separating them to loosen them or bringing them closer together to tighten them).

[0246] If further adjustment of the headgear strap assembly 3330 is required, the adjustment can be made via the buckle 3360 as described above. For example, the headgear strap assembly 3330 can be tightened by pulling the free ends of the back strap portions 3344a and 3344b away from the buckle 3360 (e.g., via the reinforcing portion or finger tab 3347) as shown in Figure 86A. The headgear strap assembly 3330 can be loosened by grasping and pulling the strap portion on either side of the buckle 3360 or by pulling the buckle 3360 relative to the strap portion, as shown in Figure 86B.

[0247] It should be understood that the assembly of the headgear strap assembly 3330 to the patient interface 3000 may be carried out in such a way that the buckle 3360 can be positioned on either the right or left side of the patient's head, depending on the patient's preference, for example, to facilitate adjustment during wear. For example, in the case of a right-handed patient, positioning the buckle 3360 on the right side of the patient's head may be preferable because it facilitates the patient adjusting the buckle 3360 with their right hand.

[0248] At this point, the patient interface 3000 is ready to be installed and used. Specifically, the short tube 4180 of the patient interface 3000 can be connected to the air circuit 4170 to deliver pressurized gas from the air circuit 4170 to the patient interface 3000.

[0249] As shown in Figure 85, to remove the patient interface 3000, the frame assembly 3500 / cushion assembly 3075, along with the back straps 3344a and 3344b, should be pulled upward over the patient's head.

[0250] 5.3.7 Ventilation In one embodiment, the patient interface 3000 includes a vent 3400 configured and positioned to allow the expulsion of exhaled gases (e.g., carbon dioxide).

[0251] In a specific configuration, the vent 3400 is configured to allow a continuous airflow from the inside of the plenum chamber 3200 to the atmosphere when the pressure inside the plenum chamber is positive relative to the atmosphere. The vent 3400 is configured to maintain the therapeutic pressure inside the plenum chamber during use, while ensuring that the airflow is large enough to reduce patient rebreathing of exhaled CO2.

[0252] One form of the ventilation section 3400 according to this technology includes a plurality of holes (for example, about 2 or more holes, about 5 to about 50 holes, about 10 to about 40 holes, about 10 to about 20 holes, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0253] The ventilation section 3400 may be located within the plenum chamber 3200. Alternatively, the ventilation section 3400 may be located within a release structure (e.g., a swivel).

[0254] Figures 4 to 24 show a vent 3400 according to one embodiment of the present technology. In the illustrated example, the vent 3400 is provided on a frame assembly 3500 and includes a ventilating member 3450 (e.g., filter material) together with the vent passage. The vent passage is constructed and arranged to ventilate the exhaust airflow to reduce noise generation. The ventilated airflow also reduces or eliminates jets, so that the airflow does not jet onto the bed and / or neighboring partners of the patient interface.

[0255] As shown in the figure, the body 3510 includes an inner surface 3512 (along the rear side) adapted to be directed towards the interior of the plenum chamber 3200 during use (i.e., a pressurizable volume), and an outer surface 3514 (along the front side) adapted to be directed towards the atmosphere during use. A porous ventilation configuration 3515 is provided on the body 3510 at each side of the cover connection 3540. Each porous ventilation configuration 3515 includes a plurality of ventilation orifices 3516 extending from the inner surface 3512 to the outer surface 3514 through the body 3510 (to allow gas release into the atmosphere). The outer surface 3514 forms the lower part of a recessed region 3550 on the front side of the body 3510.

[0256] In the illustrated example, as best shown in Figures 21-22, each perforated ventilation configuration 3515 is configured in an arc or U-shape, with its open end oriented toward the cover connection portion 3540. Spacers 3518 (e.g., U-shaped projections) are provided on the outer surface 3514 and extend along the inner circumferential surface of each perforated ventilation configuration 3515 (to support each ventilating member 3450). The spacers 3518 support the ventilating members 3450 (spaced from the outlet ends of the outer surface 3514 and the ventilation orifice 3516, respectively) (see, for example, Figure 9).

[0257] Furthermore, since multiple ribs 3560 are provided along the outer periphery of the recessed region 3550, spaced-out ribs 3560 are obtained along the outer periphery of each porous ventilation configuration 3515. In the illustrated example, each spaced-out rib 3560 along the outer periphery of each porous ventilation configuration 3515 includes a stepped configuration comprising a first lower stage 3561 and a second upper stage 3562.

[0258] In the illustrated example, the first lower section 3561 of each spaced rib 3560 is structured and positioned to support the outer edge of each radiating member 3450. Thus, the spacer 3518, together with the first step 3561 of the spaced rib 3560, forms a raised platform. This raised platform supports the radiating member 3450 (spaced from the outer surface 3514 and the respective outlet ends of the ventilation orifice 3516) for, for example, noise minimization. Furthermore, by spacing or offsetting the radiating member 3450 from the respective outlet ends of the ventilation orifice 3516 in this way, an air gap is created, thereby always preventing the ventilation orifice 3516 from being blocked by the radiating member 3450.

[0259] As described above, the second upper section 3562 of each spaced rib 3560 is constructed and positioned to provide a stop portion on the outer edge of the front wall 3585 (when the cover 3580 is connected to the main body 3510). In another example, the second upper section 3562 of each spaced rib may not be provided. See, for example, Figure 58, in which each rib 3560 is provided only with the first step 3561.

[0260] When the cover 3580 is connected to the main body 3510, the front wall portion 3585 is supported in such a manner that it is spaced apart from the outer surface 3514 or lower part of the recessed area 3550, so that the radiating member 3450 is housed and held between the front wall portion 3585 and the spacer 3518 / first step 3561 (i.e., the main body 3510 and the cover 3580 form a casing or cartridge for the radiating member 3450). Furthermore, as described below, the outer edge or periphery of the front wall portion 3585 is spaced apart from the outer edge or periphery of the recessed area 3550, and such spacing or gap between the front wall portion 3585 and the periphery of the recessed area 3550 forms the vent outlet 3420 of the vent 3400.

[0261] As shown in the figure, each radiating member 3450 is positioned to cover each porous ventilation configuration 3515, so that the flow exiting the ventilation orifice 3516 of the porous ventilation configuration 3515 flows into the radiating member 3450. In one example, the radiating member 3450 may be made of a porous material that allows gas to pass through and radiates any jets or other flow formations exiting the ventilation orifice 3516 (e.g., nonwoven fiber material, woven fiber material). In one example, the radiating member 3450 may include a radiating material that is similar to or identical to a filter material or filter medium. In one example, the thickness of the radiating member 3450 may be about 0.1 to 10 mm (e.g., 3 to 8 mm, 5 to 7 mm), 6 to 8 mm (e.g., 7 mm), but other suitable thicknesses are also possible. In the illustrated example, the radiating member 3450 includes a single layer, but it should be understood that the radiating member 3450 may include two or more layers (for example, a lamination of similar or different radiating materials).

[0262] In one example, the cover 3580 is removably connected to the main body 3510 to allow, for example, cleaning and / or replacement of the radiating members 3450. Alternatively, instead of replacing the individual radiating members 3450, the entire frame assembly 3500 may be replaced.

[0263] The main body 3510 and the cover 3580 work together to form a ventilator that includes a ventilator inlet 3410 (i.e., the respective outlet ends of the ventilation orifices 3516) and a ventilator outlet 3420 (i.e., the gap between the front wall 3585 and the periphery of the recessed area 3550), the ventilator outlet 3420 corresponding to the ventilation outlet of the ventilation section 3400. As shown in the figure, spaced ribs 3560 are positioned within the ventilator between the ventilator inlet 3410 and the ventilator outlet 3420 to divide the ventilation flow around the frame assembly 3500.

[0264] In the illustrated example, spaced ribs 3560 are positioned to support each radiating member 3450 and to divide the airflow. In the illustrated example, additional ribs 3565 may be provided along the upper and lower sides of the cover connection 3540. Such ribs 3565 work in cooperation with ribs 3560 to divide the airflow, but are not positioned to support each radiating member 3450. In another example, such ribs 3565 may not be provided.

[0265] In another example, one or more ribs may be provided on the cover 3580. For example, one or more ribs on the cover 3580 may work in conjunction with one or more ribs provided on the body 3510 to divide the airflow. In yet another example, one or more ribs may be provided on the cover 3580 (instead of the body 3510) to divide the airflow.

[0266] In one example, one or more ribs may include a one-piece structure integral with the body 3510, and / or one or more ribs may include a one-piece structure integral with the cover 3520 (e.g., one or more ribs molded as one piece with the body 3510 and / or cover 3520). In another example, one or more ribs may be formed separately from the body 3510 and assembled to the body 3510 in a separate process, and / or one or more ribs may be formed separately from the cover 3520 and assembled to the cover 3520 in a separate process (e.g., one or more ribs may be molded separately and assembled individually to the body 3510 and / or cover 3520). However, it should be understood that one or more ribs may be provided in the ventilation in other suitable manner.

[0267] In the illustrated example (see, for example, Figure 14), spaced ribs 3560 and 3565 function as flow dividers, establishing spaced vent channels V. These vent channels V divide or allocate the exhaust vent flow around the frame assembly 3500 over the entire treatment pressure. That is, spaced ribs 3560 and 3565 are positioned and oriented relative to the vent inlet 3410 and vent outlet 3420 to divide the turbulent kinetic energy at the vent inlet 3410 (i.e., the respective outlet ends of the vent orifices 3516) in parts (for optimization of the exhaust vent flow and noise minimization). In one example, spaced-apart ribs 3560 and 3565 may divide the turbulent kinetic energy into substantially uniform portions, thereby allowing the energy to be directed evenly towards the discharge outlet 3420 (i.e., the vent outlet of the vent 3400). However, it should be understood that spaced-apart ribs 3560 and 3565 may also divide the energy into uneven portions and / or uniform portions.

[0268] The front wall portion 3585 forms the outlet 3420 (i.e., the outlet of the ventilation section 3400). It should be understood that this outlet 3420 is radially spaced outside the ventilation inlets 3517 (i.e., the respective inlet ends of the ventilation orifices 3516) and the outlet 3410 (i.e., the respective outlet ends of the ventilation orifices 3516) of the ventilation section 3400. In other words, the ventilation flow cannot flow directly through the ventilation orifices 3516 to the outlet 3420 (i.e., the ventilation outlet), but must flow at least partially radially from the ventilation inlets 3517 to the outlet 3420.

[0269] During use, the ventilation section 3400 is provided in the patient interface 3000, enabling gas flow from inside the patient interface (e.g., plenum chamber 3200) to outside the patient interface 3000 (e.g., the atmosphere). The structure and arrangement of the ventilation section 3400 are such that the flow moves into the venting section through multiple ventilation orifices 3516 of each porous ventilation configuration 3515, passes through each venting member 3450, and then provides a ventilation channel to the ventilation section outlet 3420 through divided ventilation channels V provided by spaced-apart ribs 3560 and 3565. In one example, not all of the flow necessarily needs to pass through the venting member 3450. For example, at least a portion of the flow may bypass the venting member 3450 and flow directly from the ventilation orifice into the divided ventilation channels provided by spaced-apart ribs, and then flow to the ventilation section outlet 3420.

[0270] For example, to improve the quality of a patient's sleep, the ventilation section 3400 is structured and arranged in such a way as to improve the diffusion rate of the ventilation flow in order to reduce turbulent kinetic energy and thus noise. The diffusion rate depends at least partially on the airflow through the ventilation section and along the ventilation channel, and on the wind velocity throughout the ventilation channel. Higher wind velocity results in higher turbulent kinetic energy, and turbulent kinetic energy is an indicator of noise.

[0271] In the illustrated example, the ventilation section 3400 provides several features for reducing turbulent kinetic energy. For example, the ventilation orifices 3516 included in each porous ventilation configuration 3515 are structured and arranged to prevent cross-flow and to allow for substantially equal distribution of airflow into the venting section. Spacers 3518 and spaced ribs 3560 support the venting member 3450 in a manner that is spaced apart from the ventilation orifices 3516, for example, to minimize noise and prevent blockage caused by the venting member 3450. Furthermore, spaced ribs 3560 and 3565 function as flow dividers, separating the exhaust flow to reduce turbulent kinetic energy.

[0272] The configuration of the vent 3400 can be adjusted or optimized to obtain a desired flow-pressure curve within the therapeutic pressure range. For example, one or more characteristics of the configuration of the vent 3400 can be adjusted based on, for example, ventilation requirements, acoustic requirements, therapeutic requirements, etc.

[0273] For example, the shape, size, number, orientation, and spacing of the ribs 3560 and 3565 can be optimized for flow regulation.

[0274] In one example, the number of ribs 3560 and 3565 along the recessed area may also change, for example, along with changes in the size of the ventilation assembly and / or the number and size of the ventilation orifices. In one example, the spacing between ribs may be approximately 7 to 9 mm. In one example, the frame assembly 3500 may include 5 to 30 ribs, but other appropriate numbers of ribs are also possible. For example, the frame assembly 3500 may include 10 to 20 ribs, or 8 to 15 ribs. In one example, 3 to 15 ribs (e.g., 5 to 10 ribs) may be associated with each porous ventilation configuration 3515.

[0275] In one example, ribs 3560 and 3565 may extend generally orthogonal / tangential to the main body 3510 of the frame assembly 3500. For example, ribs 3560 and 3565 may extend generally orthogonal to the main surface of the main body 3510 (e.g., the outer surface 3514). Orienting the ribs in this manner can minimize any dead space in the vent compared to, for example, ribs oriented at an acute angle to the main body 3510. Furthermore, orienting the ribs in this manner can also assist in the exit of airflow from the vent outlet 3420 (i.e., the gap between the front wall 3585 and the periphery of the recessed area) in a direction generally orthogonal to the main plane of the main body 3510, so that the airflow during use is directed away from the patient's face.

[0276] In one example, ribs 3560 and 3565 each have a generally thin thickness (e.g., associated with 1-2 mm (e.g., 1.2 mm)). This thinness allows for a wider airflow channel, thus maximizing the airflow space. However, other suitable thicknesses are also possible.

[0277] In one example, the shape, size, orientation, and number of ventilation orifices 3516 in each porous ventilation configuration 3515 may be adjustable. In one example, each ventilation orifice is generally circular and may have a diameter in the range of approximately 0.7 to 1.2 mm (e.g., 1 mm). In one example, each ventilation orifice may include a taper or draft angle, for example, the diameter of each ventilation orifice may decrease as it approaches the inlet end on the inner surface and the outlet end on the outer surface. In the illustrated example, each porous ventilation configuration 3515 includes 8 orifices, but other appropriate numbers of orifices are possible. For example, each porous ventilation configuration 3515 may include 2 to 30 orifices (e.g., 5 to 20 orifices, 5 to 10 orifices, 6 to 8 orifices).

[0278] In one example, the axes of the flow paths through each of the vent orifices 3516 can be parallel to each other or angled in a divergent direction, thereby avoiding cross-flow and thus avoiding increased noise.

[0279] In one example, the size of the front wall 3585 can be adjusted to accommodate the size of the ventilation outlet 3420 (i.e., the gap between the front wall 3585 and the periphery of the recessed area).

[0280] In one example, the thickness, material, and shape of each radiating member 3450 can be adjusted. In one example, each radiating member 3450 is shaped to cover the ventilation orifice 3516 of each porous ventilation configuration.

[0281] In one example, it should be understood that adjusting one or more parameters in conjunction with one or more other parameters of the vent 3400 leads to optimization of diffusion and reduction of turbulent kinetic energy, which in turn leads to noise reduction. For example, adjusting a specific ratio between parameters may optimize diffusion. In one example, the size / number of ribs 3560 and 3565 may be adjusted together with the size / number of ventilation orifices 3516. For example, an exemplary ratio of rib number to orifice number is 0.5 to 1.0 (e.g., 0.6 to 0.8), but other appropriate ratios are also possible. In another example, the size / number of ribs 3560 and 3565 may be adjusted together with the overall dimensions of the patient interface 3000.

[0282] Although the ventilation section 3400 is described in relation to a nasal cradle-type patient interface, it should be understood that one or more embodiments of the ventilation section 3400 may be applied to other types of patient interfaces (e.g., nasal-type patient interfaces, full-face-type patient interfaces, nasal prong-type patient interfaces).

[0283] In one example, the frame assembly 3500 and its ventilator 3400 shown in Figures 4 to 24 may include a frame / ventilator configuration for single-patient / multipurpose (SPMU) use (e.g., home use). In another example, a separate frame assembly may be provided for a patient interface for multi-patient / multipurpose (MPMU) use (e.g., sleep lab or hospital use).

[0284] The patient interface 6000 shown in Figures 76 to 82C includes an MPMU frame assembly 6500 according to an example of this technology. In the illustrated example, the patient interface 6000 is substantially similar to the patient interface 3000, except that the frame assembly 3500 is replaced with the frame assembly 6500 for MPMU applications. As shown, the frame assembly 6500 also functions as a central hub, to which the cushion assembly 3075, positioning and stabilization structure 3300 and short tube 4180 are connected (e.g., in a removable or more permanent manner).

[0285] In this example, the frame assembly 6500 is similar to the frame assembly 3500 but includes a different ventilation configuration. As shown in the figure, the ventilation section 6400 included in the frame assembly 6500 does not include a ventilator, in contrast to the ventilation section 3400, and only the porous ventilation configuration 6515 is provided on the main body 6510 on each side of the connection port 3600. Such a frame assembly 6500 provides a structure that may be able to accommodate a wider range of MPMU applications and requirements (e.g., easier cleaning / decontamination between uses, reduced number of parts, and higher rigidity / durability to withstand frequent use).

[0286] Each porous ventilation configuration 6515 includes multiple ventilation orifices 6516 extending from an inner surface 6512 (adapted to be directed towards the interior of the plenum chamber 3200 during use (i.e., a pressurized volume)) through the body 6510 to an outer surface 6514 (adapted to be directed towards the atmosphere during use), thereby enabling gas release into the atmosphere.

[0287] In the illustrated example, the ventilation orifices 6516 of each porous ventilation configuration 6515 may be arranged in rows. As shown in Figures 81, 82A, and 82B, the outer surface 6514 of the main body may provide spaced (e.g., generally parallel) surface areas 6525 with a stepped layout, and the outlet ends of the ventilation orifices 6516 of each row are positioned along each of the surface areas 6525. That is, such a stepped arrangement of surface areas 6525 can be provided by ridges or ribs 6524 that may be included in the outer surface 6514 of the main body. In the illustrated example, the ridges 6524 are positioned on each side of the connection port 3600 such that the surface area 6525 gradually decreases as it moves away from the connection port 3600 (e.g., the ridges of the surface area 6525 gradually decrease as it moves away from the connection port 3600). This arrangement directs the axes of the flow paths through each of the ventilation orifices 6516 to be either parallel to each other or angled away from each other, thereby avoiding cross-flow and noise. In one example, the raised portion or rib 6524 may facilitate the manufacturing (e.g., molding) of the frame assembly 6500 and its ventilation portion 6400.

[0288] It should be understood that each porous ventilation configuration 6515 may include any appropriate number of rows (e.g., 2 to 10 rows, 3 to 5 rows), and each row may include any appropriate number of ventilation orifices (e.g., 1 to 20 ventilation orifices, 2 to 10 orifices, 2 to 5 orifices). It should also be understood that each porous ventilation configuration 6515 may include ventilation orifices arranged in other ways (e.g., as rows, randomly arranged in the radial direction).

[0289] The shape, size, orientation, and number of ventilation orifices 6516 in each perforated ventilation configuration 6515 can be adjusted. In one example, each ventilation orifice is generally circular in shape, and its diameter may be in the range of approximately 0.7 to 1.2 mm (e.g., 1 mm). In one example, each ventilation orifice may include a taper or draft angle, for example, the diameter of each ventilation orifice may decrease as it approaches the inlet end on the inner surface and the outlet end on the outer surface. In the illustrated example, each perforated ventilation configuration 6515 is provided with 18 orifices, but other appropriate numbers of orifices are possible. For example, each perforated ventilation configuration 6515 may be provided with 2 to 40 orifices (e.g., 5 to 25 orifices, 10 to 20 orifices).

[0290] The short pipe 4180 may be permanently or removablely connected to the connection port 3600. In one example, as shown in Figure 82C, the short pipe 4180 and the connection 3600 may include a snap or interlocking fit assembly. For example, the cuff 4185 of the short pipe 4180 includes a peripheral groove 4186 adapted to engage with a peripheral bead 3605 along the interior of the connection port 3600. However, it should be understood that the connection of the short pipe 4180 to the connection port 3600 may be made in other suitable manners (e.g., removable or more permanent).

[0291] Similar to the frame assembly 3500, the pair of rigidizer arms 3302 of the positioning and stabilizing structure 3300 are connected to each side of the frame assembly 6500 by a pair of flexible joints 3305, respectively. The headgear strap assembly 3330 may be connected to the rigidizer arms 3302 as described above.

[0292] Furthermore, the frame assembly 6500 includes a cushion connection portion 6530 similar to the cushion connection portion 3530 of the frame assembly 3500 (which is structured and arranged to connect the cushion assembly 3075 to the frame assembly 6500 in a manner that allows it to be released, as described above).

[0293] 5.3.8 Decoupled Structures (Multiple or Single) In one embodiment, the patient interface 3000 includes at least one decoupling structure (e.g., a swivel or bulbolar fovea).

[0294] 5.3.9 Connection Ports Connection port 3600 allows connection to the air circuit 4170.

[0295] 5.3.10 Forehead support In one embodiment, the patient interface 3000 includes a forehead support 3700. For example, Figure 3A shows a non-invasive patient interface 3000 according to one aspect of the Art, which includes a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 in one form for connection to an air circuit 4170, and a forehead support 3700.

[0296] 5.3.11 Suffocation prevention valve In one embodiment, the patient interface 3000 includes an asphyxiation prevention valve.

[0297] 5.3.12 Ports In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one embodiment, this enables a clinician to supply supplemental oxygen. In one embodiment, this enables direct measurement of the gas (e.g., pressure) within the plenum chamber 3200.

[0298] 5.4 Air Circuit An air circuit 4170 according to one aspect of this technology is a conduit or tube constructed and positioned so that airflow moves between two components (e.g., an RPT device 4000 and a patient interface 3000) during use.

[0299] In detail, the air circuit 4170 may be fluidly connected to the patient interface and the outlet of the pneumatic block of the RPT device 4000. The air circuit may be called an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0300] In some embodiments, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (for example, to maintain or raise the air temperature). The heating elements may take the form of a heating wire circuit and may include one or more transducers (e.g., temperature sensors). In one embodiment, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating elements may communicate with a controller (e.g., a central controller). One embodiment of the air circuit 4170 including a heating wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety.

[0301] 5.4.1 Oxygen Delivery In one embodiment of this technology, supplemental oxygen can be delivered to one or more points in the pneumatic pathway (e.g., upstream of the pneumatic block), the air circuit 4170, and / or the patient interface 3000.

[0302] 5.5 Glossary For the purposes of disclosing this technology, one or more of the following definitions may apply in certain forms of this technology. Other definitions may also apply in other forms of this technology.

[0303] 5.5.1 General 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 oxygen-rich atmosphere).

[0304] Atmosphere: In certain forms of this technology, the term “atmosphere” should be understood to mean (i) the area outside the treatment system or patient, and (ii) the area directly surrounding the treatment system or patient.

[0305] For example, ambient humidity for a humidifier can be the humidity of the air directly surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). This ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0306] In another embodiment, the ambient pressure may be the pressure directly surrounding or outside the body.

[0307] In certain forms, ambient (e.g., acoustic) noise can be considered the background noise level in the patient's room, excluding noise originating from, for example, RPT devices or masks or patient interfaces. Ambient noise may originate from sources outside the room.

[0308] Automatic positive airway pressure (APAP) therapy: CPAP therapy that can automatically adjust the therapeutic pressure between minimum and maximum limits between breaths, for example, depending on the presence or absence of signs of SDB onset.

[0309] Continuous positive airway pressure (CPAP) therapy: Respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway entrance increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure fluctuates between different respiratory cycles of the patient (e.g., increased in response to the detection of signs of partial upper airway obstruction and decreased in the absence of such indications).

[0310] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, when flow rate is mentioned, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, when flow rate is mentioned, it refers to a vector quantity (i.e., a quantity that has both magnitude and direction). Flow rate may be denoted by the sign Q. Flow rate is sometimes simply called "flow" or "airflow."

[0311] In the patient's respiratory embodiment, the flow rate can be negative relative to the expiratory portion of the patient's respiratory cycle, as it can be nominally positive relative to the inspiratory portion of the patient's respiratory cycle. Total flow rate Qt is the flow rate of air exiting the RPT device. Vent flow rate Qv is the flow rate of air exiting the vents to allow the exhaled gas to escape. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or other locations. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0312] Humidifier: The term "humidifier" is interpreted as a humidifying device that is constructed, positioned, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor into the airflow to improve a patient's medical respiratory condition.

[0313] Leakage: The term "leakage" is taken to mean unintended airflow. In one embodiment, leakage may occur due to an incomplete seal between the mask and the patient's face. In another embodiment, leakage may occur at the swivel elbow relative to the surroundings.

[0314] Conducted Noise (Acoustics): In this document, conducted noise refers to noise transmitted to a patient via pneumatic pathways (e.g., air circuits and patient interfaces and the air within them). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0315] Noise Radiation (Acoustic): In this document, radiated noise refers to noise transmitted to the patient by the surrounding air. In one form, radiated noise can be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO 3744.

[0316] Noise from ventilation (acoustics): In this document, ventilation noise refers to noise generated by airflow through any ventilation (e.g., ventilation holes in a patient interface).

[0317] Patient: A person who has or does not have a respiratory illness.

[0318] Pressure: Force per unit area. Pressure can be expressed in various units (e.g., cmH2O, gf / cm²). 2 , and hectopascals). 1 cmH2O is 1 g-f / cm 2 This is equal to approximately 0.98 hectopascals. In this specification, unless otherwise specified, pressure is given in units of cmH2O.

[0319] The pressure within the patient interface is denoted by the symbol Pm, and the therapeutic pressure, which represents the target value that the mask pressure Pm should currently achieve, is denoted by the symbol Pt.

[0320] Respiratory pressure therapy (RPT): Addition of air supply to the airway inlet at therapeutic pressure, which is typically positive pressure relative to the atmosphere.

[0321] Ventilator: A mechanical device that provides pressure assistance to help a patient perform some or all of the breathing motion.

[0322] 5.5.1.1 Materials Silicone or silicone elastomer: synthetic rubber. In this specification, when silicone is referred to, it refers to liquid silicone rubber (LSR) or compression-molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the product line sold under this registered trademark), manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified, the Shore A (or Type A) indentation hardness of exemplary forms of LSR, as measured by ASTM D2240, is approximately 35 to approximately 45.

[0323] Polycarbonate is a thermoplastic polymer of bisphenol A carbonate.

[0324] 5.5.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0325] Resilient: Releases virtually all energy upon unloading. Includes, for example, certain silicones and thermoplastic elastomers.

[0326] Hardness: The ability of a material to resist deformation (described, for example, by Young's modulus or indentation hardness scale measured on a standardized sample size). • "Flexible" materials may include silicone or thermoplastic elastomer (TPE) and can be easily deformed, for example, under finger pressure. "Hard" materials may include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0327] 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, extension, bending, or torsion). A structure or component may provide different resistance in different directions.

[0328] Floppy structure or component: A structure or component that changes shape (e.g., bends) within a relatively short period of time (e.g., 1 second) when subjected to its own weight.

[0329] Rigid structure or component: A structure or component that remains substantially unchanged in shape when subjected to loads typically encountered during use. An example of such an application might be setting up and maintaining a patient interface in a sealed state against the patient's airway inlet under a pressure load of, for example, approximately 20-30 cmH2O.

[0330] In one embodiment, an I-beam may have different bending stiffnesses (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another embodiment, a structure or component may be floppy in the first direction and rigid in the second direction.

[0331] 5.5.2 Respiratory cycle Apnea: According to some definitions, apnea is said to occur when airflow falls below a certain threshold for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when airflow is not permitted due to some airway obstruction despite the patient's exertion. Central apnea is said to refer to a condition in which apnea is detected due to decreased or absent respiratory effort, even though the airway is open. Mixed apnea is said to refer to a condition in which decreased or absent respiratory effort occurs simultaneously with airway obstruction.

[0332] Respiratory rate: This is the patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0333] Load cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0334] Exercise (breathing): Breathing effort is said to refer to the movements performed by a person's spontaneous breathing.

[0335] The exhalation portion of the respiratory cycle: the period from the start of the exhalation flow to the start of the inhalation flow.

[0336] Flow limitation: Flow limitation is interpreted as a situation in a patient's respiration where increased exertion by the patient does not result in a corresponding increase in flow rate. If flow limitation occurs during the inspiratory portion of the respiratory cycle, it may be called inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, it may be called expiratory flow limitation.

[0337] Types of flow-restricted intake waveforms: (i) Flattening: A period of rising followed by a relatively flat section, after which a descent occurs. (ii) M-shaped: It has two local peaks, one at the rise and one at the fall, with a relatively flat area between these two peaks. (iii) Chair-shaped: It has a single localized peak, which rises up and is followed by a relatively flat section. (iv) Inverted chair shape: A relatively flat area is followed by a single localized peak, which occurs in a sloping section.

[0338] Respiratory depression: According to some definitions, respiratory depression refers to a decrease in flow, rather than an interruption of flow. In one morphology, respiratory depression is said to have occurred if a decrease in flow below a threshold velocity persists for a period of time. If respiratory depression is detected due to a decrease in respiratory effort, it is said to have occurred. In one morphology of an adult, respiratory depression may be considered if any of the following occurs: (i) A 30% decrease in patient respiration lasting at least 10 seconds + associated 4% desaturation, or (ii) The patient's respiration decreases by less than 50% for at least 10 seconds, and associated desaturation is at least 3% or awakening occurs.

[0339] Hyperventilation: A condition in which blood flow increases to a level higher than normal.

[0340] The inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0341] Airway patency: The degree to which the airway is open or the extent to which the airway is open. Airway patency is defined as opening. Airway patency can be quantified, for example, using a value of (1) indicating patency and a value of (0) indicating closure (obstruction).

[0342] Positive end-respiratory pressure (PEEP): This is the pressure in the lungs that exceeds the atmospheric pressure, and is present at the end of exhalation.

[0343] Peak flow rate (Qpeak): The maximum flow rate in the inspiratory portion of the respiratory flow waveform.

[0344] Respiratory airflow, airflow, patient airflow, respiratory airflow (Qr): These terms may be understood to refer to the estimation of respiratory airflow by an RPT device and are used in contrast to "true respiratory flow" or "true respiratory airflow," which is the patient's actual respiratory flow, usually expressed in liters / minute.

[0345] Tidal volume (Vt): This is the amount of air inhaled or exhaled during normal breathing without extra effort. In principle, since inspiratory volume Vi (amount of air inhaled) is equal to expiratory volume Ve (amount of air exhaled), a single tidal volume Vt can be defined as being equal to either of these amounts. In practice, tidal volume Vt is estimated as some combination (for example, the average of inspiratory volume Vi and expiratory volume Ve).

[0346] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0347] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0348] (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.

[0349] Typical recent ventilation: Ventilation values ​​where recent ventilation values ​​tend to cluster together over a given time scale (i.e., the degree of clustering of recent ventilation values).

[0350] Upper airway obstruction (UAO): Includes both partial and total upper airway obstruction. It may be associated with flow-limiting conditions in which flow rate may slightly increase or decrease with increasing pressure differences over the upper airway (Stirling register behavior).

[0351] Ventilation: A measurement of the rate of gas exchange performed by a patient's respiratory system. Ventilation measurements may include either or both inspiratory and expiratory airflow per unit time. When expressed as volume per minute, this volume is often called "minute ventilation." Minute ventilation may also simply be given as volume and understood as volume per minute.

[0352] 5.5.3 Ventilation Adaptive servo ventilators (ASVs): Servo ventilators that have a variable target ventilation rather than a fixed target ventilation. The variable target ventilation can be learned from some characteristic of the patient (e.g., the patient's respiratory characteristics).

[0353] Backup rate: A ventilator parameter that establishes the minimum respiratory rate (typically respiratory rate per minute) delivered from the ventilator to the patient (when not triggered by spontaneous respiratory effort).

[0354] Cycle: The end of the inspiratory phase of a ventilator. When a ventilator delivers air to a patient who is breathing spontaneously, it is said that the ventilator cycles to stop delivering air at the end of the inspiratory portion of the respiratory cycle.

[0355] Positive expiratory airway pressure (EPAP): The base pressure to which varying pressures within respiration are added in order for a ventilator to generate the desired mask pressure that it attempts to achieve at a given time.

[0356] End-of-Expiratory Pressure (EEP): The desired mask pressure that the ventilator aims to achieve at the end of the expiratory portion of respiration. When the pressure waveform template Π(Φ) is zero at the end of exhalation (i.e., Π(Φ)=0 when Φ=1), EEP is equal to EPAP.

[0357] Positive Inspiratory Airway Pressure (IPAP): The maximum desired mask pressure that a ventilator attempts to achieve during the inspiratory portion of breathing.

[0358] Pressure assist: A number indicating the pressure increase during exhalation of a ventilator from the inspiratory phase, primarily representing the pressure difference between the maximum inspiratory pressure and the baseline pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure assist refers to the difference the ventilator aims to achieve (rather than the difference it actually achieves).

[0359] Servo ventilator: A ventilator that has both patient ventilation and target ventilation, and adjusts the pressure support level to bring patient ventilation closer to the target ventilation.

[0360] Spontaneous / Timing (S / T): A mode of a ventilator or other device that attempts to detect the start of breathing in a patient who is breathing spontaneously. However, if the device fails to detect breathing within a predetermined period, the device automatically initiates respiratory delivery.

[0361] Swing: A term equivalent to pressure assistance.

[0362] Trigger: When a ventilator delivers air to a patient who is breathing spontaneously, the ventilator is said to be triggered to deliver air when the patient initiates the respiratory portion of the respiratory cycle.

[0363] 5.5.4 Anatomy 5.5.4.1 Anatomical structure of the face Wing (Ala): The "wing" of the outer wall or each nostril (plural: alar)

[0364] Wing angle:

[0365] Alare: The outermost point on the nasal ala.

[0366] Wing curvature (or nostril apex) point: The furthest point on the curved reference line of each wing, found at the fold formed by the joining of the wing and cheek.

[0367] Auricle: The entire visible part of the ear.

[0368] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0369] (Nasal) cartilage: The cartilage of the nose includes the septal cartilage, lateral cartilage, macrocartilage, and microcartilage.

[0370] Columella: A piece of skin that separates the nostrils, extending from the tip of the nose to the upper lip.

[0371] Columella angle: The angle between a line drawn through the midpoint of the nostrils and a line drawn perpendicular to the Frankfurt horizontal while intersecting the subnasal point.

[0372] Frankfort horizontal plane: A line extending from the lowest point of the orbital rim to the left auricle. The auricle is the deepest point from the upper side of the notch to the tragus of the auricle.

[0373] Glabella: Located in soft tissue, it is the most prominent point in the midline sagittal direction of the forehead.

[0374] Lateral nasal cartilage: A generally triangular plate of cartilage. Its upper margin is attached to the nasal bone and the frontal process of the maxilla, and its lower margin is connected to the greater alar cartilage.

[0375] Lip, lower side (lower lip: labrale inferius):

[0376] Lip, upper side (upper lip: labrale superius):

[0377] Greater alar cartilage: A plate of cartilage located beneath the lateral nasal cartilage. It curves around the anterior portion of the nostril. Its posterior end connects to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.

[0378] Nostrils: Generally, ellipsoidal pterygoides form the entrance to the nasal cavity. The singular form of nostril (nares) is nostril (naris). These nostrils are separated by the nasal septum.

[0379] Nasolabial fold or groove: A fold or groove in the skin that extends from each side of the nose to the corners of the mouth, separating the cheek from the upper lip.

[0380] Nasolabial angle: The angle between the columella and the upper lip, which intersects with the subnasal point.

[0381] Inferior basement point: The lowest point where the auricle attaches to the skin of the face.

[0382] Superior basement point: The highest point where the auricle attaches to the skin of the face.

[0383] Nasal tip: The most prominent point or tip of the nose, which can be seen in a lateral view of the rest of the head.

[0384] Philtrum: The midline groove extending from the lower boundary of the nasal septum to the upper part of the lip in the upper lip region.

[0385] Pogonion: The anterior midpoint of the jaw, located on soft tissue.

[0386] Nasal ridge: The nasal ridge is the midline elevation of the nose, extending from the therion to the nasal tip.

[0387] 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 the plane into the right and left halves.

[0388] Serion: The most concave point located on soft tissue within the region of the frontonasal suture.

[0389] Septal cartilage (nose): The nasal septum cartilage is part of the septum and divides the anterior part of the nasal cavity.

[0390] The lowest point of the nasal ala: This is a point on the lower periphery of the wing base, where the wing base joins the skin of the upper lip.

[0391] Subnasal point: Located on soft tissue, this is the point where the columella merges with the upper lip in the midline sagittal direction.

[0392] Supramenton: The most concave point on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue pogonion.

[0393] 5.5.4.2 Anatomical structure of the skull Frontal bone: The frontal bone includes the frontal squama, a large vertical portion that corresponds to the area known as the forehead.

[0394] Mandible: The mandible forms the lower jaw. The mental protuberance is a bony protuberance in the jaw and forms the jawbone.

[0395] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the orbit. The frontal process of the maxilla projects upward from the side of the nose, forming its lateral boundary.

[0396] Nasal bones: The nasal bones are two small rectangular bones that vary in size and shape from person to person. The nasal bones are located side by side in the middle and upper parts of the face, and their joint forms the "bridge" of the nose.

[0397] Nasal root point: The intersection of the frontal bone and the two nasal bones, a concave area directly located between the upper part of the bridge between the eye and the nose.

[0398] Occipital bone: The occipital bone is located in the posterior and inferior part of the skull. The occipital bone contains the foramen magnum, an oval opening through which the intracranial cavity is connected to the vertebral canals. The curved plate on the posterior side of the foramen magnum is the occipital squama.

[0399] Orbit: A bony cavity within the skull that contains the eyeball.

[0400] Parietal bone: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0401] 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.

[0402] Cheekbones: The two cheekbones in the face are located in the upper and lateral parts of the face, forming the cheekbones.

[0403] 5.5.4.3 Anatomical structure of the respiratory system The diaphragm is a sheet of muscle that extends over the lower part of the rib cage. It 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, drawing air into the lungs.

[0404] Larynx: The larynx or vocal organ that houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0405] Lungs: The respiratory organ in humans. The conductive zone of the lungs includes the trachea, bronchi, terminal bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchi, alveolar ducts, and alveoli.

[0406] Nasal cavity: The nasal cavity (or nasal fossa) is a large, air-filled space located in the center of the face, above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called nasal conchae (singular "concha") or nasal bones. The nose is located anterior to the nasal cavity, and posteriorly it connects to the nasopharynx via the posterior nostrils.

[0407] Pharynx: The part of the throat located directly below the nasal cavity and above the esophagus and larynx. The pharynx is traditionally divided into the following three parts: nasopharynx (upper pharynx) (the nasal part of the pharynx), oropharynx (oropharynx) (the oral part of the pharynx), and pharynx (lower pharynx).

[0408] 5.5.5 Patient Interface Anti-choking valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to the atmosphere in a fail-safe manner.

[0409] Elbow: An elbow is an embodiment of a structure that directs the axis of airflow moving within, changing its direction through an angle. In one embodiment, the angle may be approximately 90 degrees. In another embodiment, the angle may be greater than or less than 90 degrees. An elbow may have a substantially circular cross-section. In another embodiment, an elbow may have an elliptical or rectangular cross-section. In certain embodiments, an elbow may be rotatable, for example, about 360 degrees relative to a mating component. In certain embodiments, an elbow may be detachable from a mating component, for example, via a snap connection. In certain embodiments, an elbow may be assembled to a mating component via a one-time snap during manufacturing, but cannot be detached by the patient.

[0410] Frame: The term "frame" is taken to mean a mask structure that supports tensile loads between two or more points connecting the headgear. The mask frame can be an airtight load-supporting structure within the mask. However, some forms of mask frames may be airtight.

[0411] Functional dead space:

[0412] Headgear: Headgear is taken to mean a form of positioning and stabilization structure designed for use on the head. For example, headgear may include a collection of one or more struts, ties, and stiffeners configured to position and hold a patient interface in place on the patient's face for the delivery of respiratory therapy. Some ties may be formed from a soft, flexible, elastic material (e.g., a layered composite of foam and fabric).

[0413] Membrane: The term "membrane" is typically used to mean a thin-walled element, preferably one that offers little resistance to bending and little resistance to stretching.

[0414] Plenum Chamber: The term "mask plenum chamber" is taken to mean a part of the patient interface having a wall that at least partially encloses the volume of space, where the air in the volume is pressurized to exceed atmospheric pressure when in use. A shell may form part of the wall of the mask plenum chamber.

[0415] Seal: When used as a noun ("seal"), it can refer to a structure; when used as a verb ("to seal"), it can refer to the effect of sealing. Two elements can be constructed and / or arranged to "seal" or achieve a "sealing" effect between them without requiring a separate "seal" element itself.

[0416] Shell: The term "shell" is used to mean a curved, relatively thin-walled structure with bending, tensile, and compressive rigidity. For example, the curved structural walls of a mask can be a shell. In some forms, a shell can be faceted. In some forms, a shell can be airtight. In some forms, a shell may not be airtight.

[0417] Stiffener: The term "stiffener" is understood to mean a structural component designed to increase the rigidity of another component in at least one direction.

[0418] Support: The term "support" is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0419] Swivel (noun): A subassembly of components configured to rotate preferably independently and preferably under low torque around a common axis. In one embodiment, the swivel may be configured to rotate at an angle of at least 360 degrees. In another embodiment, the swivel may be configured to rotate at an angle of less than 360 degrees. When used in the context of air delivery conduits, the subassembly of components preferably includes a pair of cylindrical conduits. During use, there is little to no leakage of airflow from the swivel.

[0420] Thai (noun): A structure designed to resist tension.

[0421] Ventilation (noun): A structure that allows air to flow into the surrounding air inside a mask or conduit, enabling clinically effective flushing of exhaled gases. For example, clinically effective flushing may involve flow rates of approximately 10 liters / minute to 100 liters / minute, depending on the mask design and treatment pressure.

[0422] 5.5.6 Structure Shape Products based on this technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or an impeller). The three-dimensional structure may be limited by two-dimensional surfaces. These surfaces may be distinguished using labels to describe the orientation, position, function or any other characteristic of the associated surface. For example, the structure may include one or more of a front surface, a back surface, an inner surface, and an outer surface. In another embodiment, the seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., lower or inner) surface. In another embodiment, the structure may include a first surface and a second surface.

[0423] To facilitate the description of the shape and surface of the three-dimensional structure, we first consider the cross-section at point p through the surface of the structure. Please refer to Figures 3B to 3F. Figures 3B to 3F show examples of cross-sections at point p on the surface and examples of the resulting planar curves. Figures 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 hypothetical small person standing upright on the surface.

[0424] 5.5.6.1 Curvature in one dimension The curvature of a plane curve at p can be described as having a sign (e.g., positive, negative) and magnitude (e.g., 1 / radius of a circle tangent to the curve at p).

[0425] Positive curvature: When a curve at point p curves toward the outward normal, the curvature at that point is taken to have a positive value (if this hypothetical little person were to leave point p, they would need to walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such a curve is often called concave.

[0426] Zero curvature: If the curve at point p is a straight line, the curvature is taken as zero (if this hypothetical small person leaves point p, they can walk on a horizontal plane that is neither upward nor downward). See Figure 3D.

[0427] Negative curvature: When a curve at point p curves away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (if this hypothetical little person were to walk away from point p, they would need to walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F) and Figure 3F (relatively large negative curvature compared to Figure 3E). Such curves are often called convex.

[0428] 5.5.6.2 Curvature of a two-dimensional surface The description of the shape at a given point on a two-dimensional surface using this technique may include multiple perpendicular cross-sections. These cross-sections can cut the surface in a plane containing an outward normal ("normal plane"), and each cross-section may be taken in a different direction. Each cross-section results in a planar curve with a corresponding curvature. The different curvatures at that point may have the same or different signs. Each curvature at that point has a magnitude (e.g., relatively small). The planar curves in Figures 3B to 3F may be examples of such multiple cross-sections at a particular point.

[0429] Major curvature and direction: The direction of the normal plane in which the curvature of a curve takes its maximum and minimum values ​​is called the major direction. In the examples in Figures 3B to 3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F; therefore, Figures 3B and 3F are cross-sections in the major direction. The major curvature at p is the curvature in the major direction.

[0430] A region of a surface: A set of connected points on a surface. These points within a region may share similar properties (e.g., curvature or sign).

[0431] Saddle region: A region where the principal curvatures at each point have opposite signs (i.e., one positive sign and the other negative sign), depending on the direction a hypothetical person walking uphill or downhill is facing.

[0432] Dome region: A region where the main curvatures at each point have the same sign (both are positive ("concave dome") or both are negative ("convex dome")).

[0433] Cylindrical region: A region where one major curvature is zero (or, for example, zero within manufacturing tolerances) and the other major curvature is non-zero.

[0434] Planar region: A region of a surface where both major curvatures are zero (or zero, for example, within a manufacturing tolerance).

[0435] Surface edge: The boundary or limit of a surface or area.

[0436] Path: In certain forms of this technology, “path” is taken to mean a path in a mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of this technology, “path” can be described, for example, as a route or course containing a set of points on a surface. (A hypothetical person’s path is the places they walk on the surface, similar to a path in a garden).

[0437] Path Length: In certain forms of this technology, "path length" refers 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 they walk along the path on the surface).

[0438] Straight-line distance: Straight-line distance is the distance between two points on a surface, but the surface itself is not considered. On a planar region, there exists a distance on the surface edge with the same path length as the straight-line distance between two points on the surface. On a non-planar surface, no path with the same path length as the straight-line distance between two points can exist. (For a hypothetical person, straight-line distance corresponds to the distance a crow "flies".)

[0439] 5.5.6.3 Space curve Spatial curves: Unlike plane curves, spatial curves do not necessarily exist within any given plane. Spatial curves can be closed; that is, they have no endpoints. Spatial curves can be considered as one-dimensional pieces of three-dimensional space. A hypothetical person walking along a DNA helix would walk along a spatial 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 edges of structures (e.g., the edges of a membrane or impeller) can follow spatial curves. In general, spatial curves can be described by their curvature and torsion at each point on the curve. Torsion is a measure of the nature of a curve originating from a plane. Torsion has a sign and magnitude. Torsion at a point on a spatial curve can be characterized with respect to the tangent, normal, and binormal vectors at that point.

[0440] 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. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a fictional character is flying along a curve and falls from their vehicle at a certain point, the direction of the tangent vector would be the direction in which the character would have been moving.

[0441] Unit Normal Vector: When a fictional character is moving along a curve, the tangent vector itself changes. The unit vector that points in the same direction as the changing tangent vector is called the unit principal normal vector. This is perpendicular to the tangent vector.

[0442] 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, Figure 3P) or the left-hand rule (Figure 3O).

[0443] Contact plane: The plane containing the unit tangent vector and the unit principal normal vector. See Figures 3O and 3P.

[0444] Torsion of a spatial curve: Torsion of a spatial curve at a point is the magnitude of the rate of change of the binormal unit vector at that point. This measures the degree of deviation of the curve from the tangent plane. Torsion of a spatial curve in a plane is zero. If the deviation of a spatial curve from the tangent plane is relatively small, the magnitude of the torsion of that spatial curve is relatively small (e.g., a gently sloping helical path). If the deviation of a spatial curve from the tangent plane is relatively large, the magnitude of the torsion of that spatial curve is relatively large (e.g., a steeply sloping helical path). Referring to Figure 3S, since T2 > T1, the magnitude of the torsion in the neighborhood of the uppermost coil of the helix in Figure 3S is greater than the magnitude of the torsion of the lowermost coil of the helix in Figure 3S.

[0445] Referring to the right-hand rule in Figure 3P, a spatial curve curving toward the direction of the right-hand binormal can be considered to have a positive twist in the right-hand direction (e.g., a right-hand spiral as shown in Figure 3S). A spatial curve pointing away from the direction of the right-hand binormal can be considered to have a negative right-hand twist (e.g., a left-hand spiral).

[0446] Similarly, referring to the left-hand rule (see Figure 3O), a spatial curve pointing in the direction of the left-hand binormal can be considered to have a positive left-hand twist (e.g., a left-hand spiral). Thus, the positive direction of the left hand corresponds to the negative direction of the right hand. See Figure 3T.

[0447] 5.5.6.4 Hole A surface may have one-dimensional holes (e.g., holes bounded by planar or spatial curves). In the case of a thin-walled structure containing holes (e.g., a film), this structure can be described as having one-dimensional holes. See, for example, the one-dimensional holes in the surface of the structure shown in Figure 3I, bounded by planar curves.

[0448] The structure may have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the inner surface of the tire. In another embodiment, a bladder with a cavity for air or gel may have a two-dimensional hole. See, for example, the cushion in Figure 3L, and the exemplary cross-section of Figure 3L in Figures 3M and 3N, where the inner surface bounding the two-dimensional hole is shown. In yet another embodiment, a conduit may include a one-dimensional hole (e.g., at its inlet or outlet) and a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole that passes through the structure shown in Figure 3K and is bounded by a surface as shown.

[0449] 5.6 Other Notes Unless otherwise clearly indicated by the context or provided for a range of values, it is understood that 1 / 10 of the lower limit, the interval between the upper and lower limits of the range, and each intervention value for any other stated values ​​or intervention values ​​within the stated range are included in this technique. Even if the upper and lower limits of these intervention ranges, independently included within the intervention range, specifically exceed the limits within the stated range, they are also included in this technique. If the stated range includes one or both of these limits, the range exceeding either or both of these stated limits is also included in this technique.

[0450] Furthermore, where values ​​(one or more) are embodied in this specification as part of the Art, unless otherwise specified, it is understood that such values ​​may be approximated and used to any appropriate number of significant figures as permitted or required by the practical technical implementation.

[0451] Unless otherwise specified, all technical and scientific terms in this specification have the same meaning as those commonly understood by those skilled in the art. Any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this art, but only a limited number of exemplary methods and materials are described herein.

[0452] While certain materials are described as suitably used in constructing components, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are understood to be manufacturable and therefore can be manufactured collectively or individually.

[0453] Note that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0454] All published documents cited herein are used for disclosure and description of the methods and / or materials covered by those documents, and are incorporated for reference only. The published documents cited herein are provided solely for their disclosures prior to the filing date of this application. Nothing in this specification should be construed as indicating that the present technology is not prior to such published documents for the purpose of prior patents. Furthermore, the dates of the published documents cited may differ from the actual publication dates and may require individual verification.

[0455] The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that the elements, components, or steps described may exist, be used, or be combined with other elements, components, or steps not explicitly stated.

[0456] The headings used in the detailed descriptions are for the convenience of the reader and should not be used to limit the content found in this disclosure or the claims as a whole. These headings should not be used in the interpretation of the scope of the claims or the limitations of the claims.

[0457] While the techniques described herein have been referred to with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may indicate specific details that are not necessary for carrying out the techniques. For example, terms such as "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any arbitrary order and are used to distinguish separate elements. Furthermore, while the descriptions or examples of process steps in the methods may be given in order, such order is not required. Those skilled in the art will recognize that such order is changeable and / or that such actions can be performed simultaneously or even synchronously.

[0458] Therefore, it should be understood that numerous modifications are possible in the exemplary embodiments, and other configurations may be devised, without deviating from the intent and scope of this technology. [Explanation of symbols]

[0459] patient 1000 Bedmate: 1100 Patient Interface 3000 Cushion assembly 3075 nostril opening 3102 Bridge section 3104 Lateral support area 3108 Positive lateral area 3110 Intermediate area 3114 Thick cut of meat 3120 Thick cut of meat 3121 Thick cut of meat 3122 Frame connection structure 3150 Sealing connection part 3160 Frame connection part 3170 Undercut 3175 Recess 3177 Notch 3179 Plenum Chamber 3200 Tendon 3210 Top score 3220 Lower point 3230 Positioning and stabilization structure 3300 Rigidizer Arm 3302 flexible joint 3305 Headgear strap assembly 3330 Strap 3340 Side strap area 3342 Buttonhole 3343 Rear strap area 3344 Finger Tab 3345 Finger Tab 3347 Strap 3350 Side strap area 3352 Buttonhole 3353 Finger Tab 3355 Buckle 3360 Main unit 3362 First end 3364 Second end 3366 First opening 3370 surface 3375 Crossbar 3380 Crossbar 3382 Base 3390 Overmolding 3391 Ventilation section 3400 Discharge area entrance 3410 Discharge outlet / Ventilation outlet 3420 Diffusion member 3450 Frame assembly 3500 Main unit 3510 Recess 3511 Internal 3512 Exterior 3514 Porous ventilation arrangement configuration 3515 Ventilation orifice 3516 Ventilation inlet 3517 Spacer 3518 Main unit 3520 Cushion connection part 3530 Undercut 3535 Protrusion 3537 Cover central connection part 3540 Bead 3545 Concave area 3550 Rib 3560 Step 1 3561 Step 2 3562 Rib 3565 Protrusion 3577 Cover 3580 Protrusion 3581 Front wall 3585 Tube area 3590 Groove section 3595 Connection port 3600 Bead 3605 Interfacing surface 3615 Forehead support part 3700 Sealing Lip 3850 RPT device 4000 Air circuit 4170 Short pipe 4180 Cuff 4185 Groove section 4186 Humidifier 5000 Rear strap area 3344a Rear strap area 3344b Opening 3372a Opening 3372b Patient Interface 6000 Ventilation section 6400 Frame assembly 6500 Main unit 6510 Inner surface 6512 Exterior 6514 Porous ventilation arrangement configuration 6515 Ventilation orifice 6516 Ridge 6524 Surface area 6525 Cushion connection part 6530

Claims

1. A patient interface for improving sleep-disordered breathing by delivering an airflow at positive pressure relative to ambient air pressure to at least the entrance to the patient's airway, including the entrance to the patient's nostrils, during the patient's sleep, Frame assembly and, A cushion assembly configured to be removably and repeatedly connected to the frame assembly, The frame assembly and the cushion assembly form at least a portion of a plenum chamber that can be pressurized up to therapeutic pressure. The cushion assembly includes a one-piece structure comprising: a seal-forming structure constructed and positioned to form a seal against the patient's facial region surrounding the entrance to the patient's airway; and a frame-connecting structure constructed and positioned to removably and repeatedly connect the cushion assembly to a frame assembly. The seal-forming structure comprises a first elastomer material, and the frame-connecting structure comprises a second elastomer material. The first elastomer material has a lower durometer or hardness than the second elastomer material. The frame connection structure includes an undercut that functions as an interface or catch adapted for connection to the frame assembly. A patient interface in which the frame connection structure is positioned along the inner surface or inner circumference of the seal-forming structure such that the frame connection structure and its undercut are positioned or oriented toward the inside of the cushion assembly forming at least a portion of the plenum chamber.

2. The patient interface according to claim 1, wherein the seal-forming structure includes a nasal cradle cushion adapted to form a seal at least on the underside of the patient's nose.

3. The patient interface according to any one of claims 1 to 2, wherein the seal-forming structure and frame connection structure include an overmolded structure for forming a one-piece integrated component.

4. The patient interface according to claim 3, wherein the frame connection structure includes a base mold, and the seal forming structure includes an overmold provided on the base mold.

5. The patient interface according to any one of claims 1 to 4, wherein the first elastomer material and the second elastomer material each comprise a TPE or a silicone material.

6. The patient interface according to any one of claims 1 to 5, wherein the frame connection structure includes one or more interface surfaces that are structured to be joined to the seal forming structure.

7. The patient interface according to any one of claims 1 to 6, wherein the durometer of the first elastomer material is in the range of 30 to 50 Shore A, and the durometer of the second elastomer material is in the range of 60 to 90 Shore A.

8. The patient interface according to any one of claims 1 to 7, further comprising a sealing lip provided on the seal-forming structure of the first elastomer material, wherein the sealing lip is structured and arranged to form a seal with the frame assembly.

9. The patient interface according to any one of claims 1 to 8, wherein the frame assembly is relatively more rigid than the frame connection structure.

10. The patient interface according to any one of claims 1 to 9, wherein the frame connection structure and its undercut extend around the entire periphery or the inner circumferential surface of the seal forming structure.

11. A CPAP system for providing a patient with positive pressure gas for respiratory therapy, wherein the CPAP system is: An RPT device configured to supply gas flow at therapeutic pressure, A patient interface according to any one of claims 1 to 10, A CPAP system comprising: an air delivery conduit configured to pass the gas flow at the therapeutic pressure from the RPT device to the patient interface.

12. A patient interface for improving sleep-disordered breathing by delivering an airflow at positive pressure relative to ambient air pressure to at least the entrance to the patient's airway, including the entrance to the patient's nostrils, during the patient's sleep, A seal-forming structure constructed and positioned to form a seal over the patient's facial area surrounding the entrance to the patient's airway, A positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head, comprising: A first strap containing an elastic woven material, The first strap includes a side strap portion that branches into two back strap portions; A second strap containing elastic woven material, A second strap including the side strap portion; and A positioning and stabilizing structure includes a buckle constructed and arranged to connect the first strap to the second strap, and to allow length adjustment provided by the elasticity of the first strap and the second strap, and additional length adjustment, The side strap portion of the second strap includes an end connected to the buckle in an immovable manner, and the two back strap portions of the first strap are threaded through the buckle to allow the first strap to be adjustably connected to the buckle and to allow the length to be adjusted. The buckle includes a first opening and a pair of second openings, and the buckle includes a crossbar that demarcates the first opening from the pair of second openings. The two back strap portions of the first strap are threaded around the crossbar through the first opening and through one of each of the pair of second openings, thereby adjusting the connection of the two back strap portions of the first strap to the buckle. A patient interface in which the side strap portions of the first strap and the second strap are fitted to extend along the side of the patient's head, and the two back strap portions of the first strap are fitted to extend along the back of the patient's head.

13. The patient interface according to claim 12, wherein the first strap is longer than the second strap when it is at its original length in a neutral, unstretched state.

14. The patient interface according to any one of claims 12 to 13, wherein one of the two backstrap portions is adapted to be positioned above the occipital lobe of the patient, and the other of the two backstrap portions is adapted to be positioned below the occipital lobe of the patient.

15. The patient interface according to any one of claims 12 to 14, wherein the buckle includes a first end and a second end, the second end being connected to the end of the side strap portion of the second strap, and the first end being curved upward or angled relative to the second end.

16. The patient interface according to any one of claims 12 to 15, wherein each of the pair of second openings includes an angled edge or surface positioned to withstand adjustment during use.

17. The patient interface according to claim 16, wherein the buckle may include a locked position to withstand accidental adjustments resulting from friction between the two back strap portions and the angled edges or surfaces within each second opening when the buckle extends generally parallel to the two back strap portions, and the buckle may include an unlocked position when the buckle is raised or swung so that adjustments are possible due to reduced friction between the two back strap portions and the angled edges or surfaces within each second opening, with the buckle extending transversely to the two back strap portions.

18. The patient interface according to any one of claims 12 to 17, wherein the positioning and stabilizing structure further includes a pair of rigidizer arms, and the side strap portions of the first strap and the second strap are provided on each of the pair of rigidizer arms.

19. The patient interface according to claim 18, wherein each side strap portion includes a tubular configuration adapted to receive each of the rigidizer arms.

20. The patient interface according to any one of claims 12 to 19, wherein each end of the first strap includes a reinforcing portion, and the second strap includes an opposite end opposite to the end connected to the buckle which includes the reinforcing portion, and each reinforcing portion includes a different material from the first strap and the second strap.

21. A CPAP system for providing a patient with positive pressure gas for respiratory therapy, wherein the CPAP system is: An RPT device configured to supply gas flow at therapeutic pressure, The patient interface according to any one of claims 12 to 20; A CPAP system comprising: an air delivery conduit configured to pass the gas flow at the therapeutic pressure from the RPT device to the patient interface.

22. A patient interface for improving sleep-disordered breathing by delivering an airflow at positive pressure relative to ambient air pressure to at least the entrance to the patient's airway, including the nostrils, during the patient's sleep, is: A seal-forming structure constructed and positioned to form a seal with a portion of the patient's face surrounding the entrance to the patient's airway, the seal-forming structure forming at least a portion of a plenum chamber pressurized to therapeutic pressure, The ventilation assembly includes a ventilation gas flow configured to release the gas exhaled by the patient from the plenum chamber into the ambient atmosphere, wherein the ventilation assembly is configured A body including a plurality of orifices extending through the body to allow gas to be released from the plenum chamber into the ambient atmosphere; The venting member is configured and arranged such that the plurality of orifices are covered by the venting member so that the aforementioned venting gas flow passes through the venting member; It includes multiple ribs, A patient interface wherein the plurality of ribs are configured and arranged to support the dissipation members, which are spaced apart from the outlet ends of each of the plurality of orifices, and to divide the aeration gas flow into spaced-apart aeration channels downstream of the dissipation members around the main body.

23. The patient interface according to claim 22, wherein the radiating member includes a filter material.

24. The patient interface according to any one of claims 22 to 23, wherein the plurality of orifices are arranged in an arc shape or a U shape.

25. The patient interface according to any one of claims 22 to 24, wherein the plurality of ribs are arranged along the outer circumference of the plurality of orifices so as to support the outer edge of the radiating member.

26. The patient interface according to any one of claims 22 to 25, wherein the ventilation assembly further includes a spacer provided on the main body, the spacer being arranged along the inner circumference of the plurality of orifices to support the ventilating member.

27. The patient interface according to any one of claims 22 to 26, further comprising a cover for holding the radiating member to the main body.

28. The patient interface according to claim 27, wherein the main body and the cover form a dispersion section including a dispersion section inlet and a dispersion section outlet, and the plurality of ribs are arranged in the dispersion section between the dispersion section inlet and the dispersion section outlet so as to divide the ventilation gas flow.

29. The patient interface according to claim 28, wherein the inlet of the emission section is provided by the outlet end of each of the plurality of orifices.

30. The patient interface according to any one of claims 28 to 29, wherein the plurality of ribs and the radiating member are provided within a recessed region of the main body, and the outlet of the radiating portion is provided by a gap formed between the cover and the periphery of the recessed region.

31. The patient interface according to any one of claims 28 to 30, wherein the discharge outlet is arranged at a distance from the discharge inlet in the radial direction.

32. The patient interface according to any one of claims 28 to 31, wherein the plurality of ribs are structured and arranged in such a way that they divide the turbulent kinetic energy at the inlet of the radiating section into portions that are directed toward the outlet of the radiating section.

33. The patient interface according to claim 32, wherein the plurality of ribs are structured and arranged such that the turbulent kinetic energy is divided into substantially equal portions.

34. The patient interface according to any one of claims 27 to 33, wherein one or more of the plurality of ribs are provided on the cover.

35. The patient interface according to claim 34, wherein one or more of the plurality of ribs include a one-piece structure together with the cover.

36. The patient interface according to any one of claims 22 to 35, wherein each of the plurality of ribs extends generally perpendicular to the main surface of the body.

37. The patient interface according to any one of claims 22 to 36, wherein the plurality of orifices comprises a first porous ventilation configuration, and the ventilation assembly further comprises a second porous ventilation configuration spaced apart from the first porous ventilation configuration, the second porous ventilation configuration comprising a plurality of orifices extending through the body.

38. The patient interface according to claim 37, wherein the ventilation assembly further includes a second radiating member configured and positioned to cover the plurality of orifices of the second porous ventilation configuration, and the plurality of ribs include ribs configured and positioned to support the second radiating member.

39. The patient interface according to any one of claims 22 to 38, further comprising a frame assembly, wherein the seal-forming structure is provided on the frame assembly.

40. The patient interface according to claim 39, wherein the body of the ventilation assembly is provided by the frame assembly.

41. The patient interface according to any one of claims 39 to 40, wherein the frame assembly includes a connection port adapted for connection to an air delivery conduit.

42. The patient interface according to any one of claims 22 to 41, wherein the plurality of orifices are configured and arranged to avoid crossflow.

43. The patient interface according to any one of claims 22 to 42, wherein one or more of the plurality of ribs are provided on the main body.

44. The patient interface according to claim 43, wherein one or more of the plurality of ribs include a one-piece structure together with the main body.

45. A CPAP system for providing a patient with positive pressure gas for respiratory therapy, wherein the CPAP system is: An RPT device configured to supply gas flow at therapeutic pressure, The patient interface according to any one of claims 22 to 44; A CPAP system comprising: an air delivery conduit configured to pass the gas flow at the therapeutic pressure from the RPT device to the patient interface.

46. A patient interface for improving sleep-disordered breathing by delivering an airflow at positive pressure relative to ambient air pressure to at least the entrance to the patient's airway, including the nostrils, during the patient's sleep, is: A seal-forming structure constructed and positioned to form a seal with a portion of the patient's face surrounding the entrance to the patient's airway, the seal-forming structure forming at least a portion of a plenum chamber pressurized to therapeutic pressure, The system includes a ventilation section configured to provide a vent gas flow for releasing the gas exhaled by the patient from the plenum chamber into the surrounding atmosphere, The ventilation section includes a body which includes a plurality of orifices extending through the body to allow gas to be released from the plenum chamber to the ambient atmosphere. The main body includes at least one raised portion or rib that provides surface area, Each of the multiple orifice exit ends is positioned along the surface area, forming a patient interface.

47. The patient interface according to claim 46, wherein the body includes a plurality of raised portions or ribs that provide spaced surface areas, and the exit end of each of the plurality of orifices is positioned along each of the spaced surface areas.

48. The patient interface according to claim 47, wherein the plurality of raised portions or ribs are arranged to provide a stepped arrangement of surface area.

49. The patient interface according to any one of claims 47 to 48, wherein the spaced surface areas are generally parallel to one another.

50. The patient interface according to any one of claims 47 to 49, wherein the plurality of orifices are arranged in rows, and each row is arranged along each of the spaced surface areas.

51. The patient interface according to any one of claims 47 to 50, wherein the plurality of orifices comprises a first porous ventilation configuration, the ventilation portion further comprises a second porous ventilation configuration disposed at intervals from the first porous ventilation configuration, and the second porous ventilation configuration comprises a plurality of orifices extending through the body.

52. The patient interface according to any one of claims 46 to 51, further comprising a frame assembly, wherein the seal-forming structure is provided on the frame assembly.

53. The patient interface according to claim 52, wherein the body of the ventilation section is provided by the frame assembly.

54. A CPAP system for providing a patient with positive pressure gas for respiratory therapy, wherein the CPAP system is: An RPT device configured to supply gas flow at therapeutic pressure, The patient interface according to any one of claims 46 to 53; A CPAP system comprising: an air delivery conduit configured to pass the gas flow at the therapeutic pressure from the RPT device to the patient interface.

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