Conduit headgear connector for patient interface

Abstract

To provide an improved patient interface.SOLUTION: The patient interface includes: a plenum chamber at least partly defining a patient interface chamber; a seal-forming structure constructed and arranged to form a seal with a region of the patient's face, at least one conduit; at least one conduit connector configured to pneumatically connect the at least one conduit to the plenum chamber to provide a flow of air at a therapeutic pressure to the patient interface chamber for breathing by the patient; and a positioning and stabilizing structure to provide a force to hold the seal-forming structure on the patient's head, the positioning and stabilizing structure including at least one tie.SELECTED DRAWING: Figure 7

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 anyone reproduces this patent document or this patent disclosure by fax, as long as it is as described in the patent file or record of the Patent Office and for the purpose intended, but retains all copyrights for other purposes.

[0002] 1 Cross - reference to related applications This application claims the benefit of U.S. Provisional Application No. 62 / 609,909 (filing date: December 22, 2017), and the above application is hereby incorporated by reference in its entirety for all purposes.

Background Art

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

[0004] 2.2 Description of related technologies 2.2.1 The human respiratory system and its diseases The 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 individuals 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 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 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 a 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 tracheotomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can, for example, form a seal with the area of the patient's face, thereby promoting gas delivery at a sufficient distributed pressure together with the ambient pressure for therapy execution (e.g., at a positive pressure of about 10 cmH2O relative to the ambient pressure). In other treatment modalities such as oxygen delivery, the patient interface may not include a seal sufficient to promote delivery of the 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 underwater swimming or diving can be configured to protect against water intrusion from higher external pressures and not maintain internal air at a pressure higher than the surroundings.

[0026] Certain masks may not be clinically preferred in the art (e.g., if the mask blocks the air flow through the nose and only allows air flow through the mouth).

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

[0028] Certain masks may be impractical for use during sleep (e.g., when sleeping on the side in bed with the head on a 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 seal-forming structure that may be effective in one area of ​​a patient's face may be unsuitable in another area due to, for example, different shapes, structures, variability, and sensitive areas of the patient's face. For instance, the seal of swimming goggles placed 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 one design fits a wide range of different face shapes and sizes, ensuring comfort and effectiveness. To form a seal, 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 / 004310; WO2006 / 074513; WO2010 / 135785).

[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 embodiments of nasal pillow masks: International Patent Application WO2004 / 073778 (in particular, describing the features of ResMed Limited's SWIFT® nasal pillow), U.S. Patent Application 2009 / 0044808 (in particular, describing the features of ResMed Limited's SWIFT® LT nasal pillow); International Patent Applications WO2005 / 063328 and WO2006 / 130903 (in particular, describing the features of ResMed Limited's MIRAGE LIBERTY® full-face mask); and International Patent Application WO2009 / 052560 (in particular, describing the features of ResMed Limited's SWIFT® FX nasal 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 to implement one or more of the above-mentioned therapies, for example, by activating the device to generate an airflow to the airway interface. This airflow 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 met 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 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 Elise'e® 150 ventilators and ResMedVSIII® 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 also humidify the air inhaled by the patient, 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 / 034665; International Patent Application Publication WO2000 / 078381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication US2009 / 0050156; U.S. Patent Application Publication 2009 / 0044808.

[0069] [Table 2]

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

[0071] [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. [Overview of the Initiative]

[0075] 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.

[0076] A first aspect of this technology relates to a device used for screening, diagnosing, monitoring, improving, treating or preventing respiratory diseases.

[0077] Another aspect of this technology relates to a method used in screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0078] One aspect of a particular form of this technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0079] Aspects of the present technology relate to a patient interface: the patient interface includes a plenum chamber that at least partially forms a patient interface chamber pressurized to a therapeutic pressure of at least 6 cmH2O, exceeding ambient air pressure; a seal-forming structure constructed and positioned to form a seal with the patient's face region surrounding an entrance to the patient's airway; a first conduit and a second conduit, each sized and constructed to receive an airflow at therapeutic pressure for the patient's breathing; a first conduit connector configured to pneumatically connect the first conduit to the plenum chamber to provide an airflow at therapeutic pressure to the patient interface chamber for the patient's breathing; a second conduit connector configured to pneumatically connect the second conduit to the plenum chamber to provide an airflow at therapeutic pressure to the patient interface chamber for the patient's breathing; a positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head and includes at least one tie; and a positioning and stabilizing structure that includes an asphyxiation prevention valve configured to allow the patient to breathe from the atmosphere through their oral cavity in the absence of pressurized airflow. In further embodiments, at least one of the first conduit connector and the second conduit connector may include an suffocation prevention valve.

[0080] Aspects of this technology relate to a patient interface: the patient interface comprises a plenum chamber that at least partially forms a patient interface chamber pressurized to a therapeutic pressure of at least 6 cmH2O, exceeding ambient air pressure, wherein the plenum chamber includes a first plenum chamber opening and a second plenum chamber opening, each of which is sized and structured to receive an airflow at therapeutic pressure for the patient's breathing, and a seal-forming structure constructed and positioned to form a seal to the patient's facial region surrounding the entrance to the patient's airway, wherein the seal-forming structure has at least one opening internally to ensure that an airflow at therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain therapeutic pressure within the patient interface chamber for the entire patient's respiratory cycle during use. The seal-forming structure includes a first conduit and a second conduit, each sized and constructed to receive an airflow at therapeutic pressure for patient respiration; a first conduit connector configured to connect the first conduit to a first plenum chamber opening via pneumatic pressure to provide an airflow at therapeutic pressure to a patient interface chamber for patient respiration; and a second conduit connector configured to connect the second conduit to a second plenum chamber opening via pneumatic pressure to provide an airflow at therapeutic pressure to a patient interface chamber for patient respiration; and a positioning and stabilizing structure, including at least one tie, that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head, wherein the first conduit connector and the second conduit connector each include an asphyxiation prevention valve configured to allow the patient to breathe from the atmosphere through their oral cavity when there is no pressurized airflow through the first and second plenum chamber openings.

[0081] In the embodiment, (a) the anti-choking valves in each of the first conduit connector and the second conduit connector may include anti-choking valve holes, (b) each anti-choking valve hole may be shaped and sized to allow the patient to breathe when other anti-choking valve holes are blocked, (c) the anti-choking valves in each of the first conduit connector and the second conduit connector may further include anti-choking valve flaps, and (d) the anti-choking valve flaps in each of the first conduit connector and the second conduit connector may block the first conduit connector and the second conduit connector in the closed position. (e) In the open position, the anti-choking valve flaps at the first and second conduit connectors are configured to block either of the corresponding anti-choking valve holes of the connector, thereby directing the airflow at therapeutic pressure moving through either of the corresponding first and second conduit connectors toward the patient interface chamber and preventing leakage into the atmosphere through the anti-choking valve hole, and (e) in the open position, the anti-choking valve flaps at the first and second conduit connectors are configured to block the first and second conduit connectors when there is no pressurized airflow through the first and second plenum chamber holes. (f) The conduit connectors may be configured to allow the patient to breathe through their mouth from the atmosphere via either of the corresponding anti-choking valve openings of the two conduit connectors, (g) the anti-choking valve openings in each of the first and second conduit connectors may be divided by an anti-choking valve opening divider that prevents the corresponding anti-choking valve flap from passing through the anti-choking valve opening, (h) each anti-choking valve flap may include at least one vent that allows some of the airflow at therapeutic pressure to leak into the atmosphere, and (h) each of the first and second conduit connectors The choking prevention valve may include a choking prevention valve flap connector hole, and the choking prevention valve flap in each of the first conduit connector and the second conduit connector may include a choking prevention valve flap connector that connects the choking prevention valve flap to the choking prevention valve flap connector hole of the corresponding choking prevention valve in either the first conduit connector or the second conduit connector, (i) the choking prevention valves in each of the first conduit connector and the second conduit connector may be configured to operate independently of each other, and (h) each of the first conduit connector and the second conduit connector may be,(k) The patient interface chamber may include at least one conduit connector vent configured to allow a continuous flow of exhaled gas by the patient from inside the chamber to the atmosphere, the at least one conduit connector vent being sized and shaped to maintain therapeutic pressure inside the patient interface chamber during use, and (k) each of the first and second conduit connectors being configured to direct a continuous flow of exhaled gas by the patient from inside the patient interface chamber to at least one conduit connector vent (l) Each of the first and second conduit connectors may include a conduit connector vent outlet configured to direct a continuous flow of exhaled gas by the patient from at least one conduit connector vent to the atmosphere; (m) Each of the first and second conduit connectors may include a partition that prevents airflow at therapeutic pressure passing through each of the first and second conduit connectors from passing directly to the atmosphere through at least one conduit connector vent; (n) The first and second conduit connectors Each of the conduit connectors may include a diffuser cavity containing diffuser material, (o) the diffuser cavity and diffuser material may be positioned downstream of a continuous gas flow from at least one conduit connector vent to diffuse the continuous gas flow before it leaks into the atmosphere, (p) each of the first and second conduit connectors may include a diffuser cover that encloses the diffuser material in the diffuser cavity, (q) the diffuser cover may be removable to allow removal and replacement of the diffuser material, (l) the first conduit connector and the second conduit Each connector may include a conduit connector vent outlet positioned so that at least a portion of a continuous gas flow passes through a diffuser material before leaking into the atmosphere through the conduit connector vent outlet, (s) each of the first and second conduit connectors may include a conduit connector spacer that maintains a gap between each of the first and second conduit connectors and a portion of the plenum chamber to allow a continuous gas flow to leak from each of the first and second conduit connectors into the atmosphere, (t) the plenum chamber is(u) The plenum chamber may include at least one plenum chamber vent, (v) Each of the first conduit connector and the second conduit connector may include a conduit connection end configured to connect to the corresponding of the first conduit and the second conduit, (w) Each of the first conduit connector and the second conduit connector may include a conduit connector end defining a conduit connector inlet hole configured to receive airflow at therapeutic pressure from the corresponding of the first conduit and the second conduit, (x) The first conduit Each of the nector and the second conduit connector may include a conduit connector outlet defining a conduit connector outlet hole configured to direct airflow at therapeutic pressure into the patient interface chamber, (y) each conduit connector end may be oriented substantially perpendicular to the corresponding conduit connector outlet, (z) the plenum chamber may include a connecting rim in either the first plenum chamber hole or the second plenum chamber hole, the first conduit connector and the second conduit connector may define a connecting rim in either the first plenum chamber hole or the second plenum chamber The patient interface may include at least one conduit connector mounting structure configured to connect to a connecting rim in either of the corresponding holes, (aa) each of the first and second conduit connectors may be detachable from the plenum chamber, (bb) each of the first and second conduit connectors may be permanently connected to the plenum chamber, (cc) each of the first and second conduit connectors may be configured to remain stationary when connected to the plenum chamber, and (dd) the patient interface is the The present invention may further include a seal between each of the first conduit connector and the second conduit connector and the corresponding of the first plenum chamber hole and the second plenum chamber hole, (ee) the seal may be formed in each of the first conduit connector and the second conduit connector, the seal may be configured to engage the plenum chamber in the corresponding of the first plenum chamber hole and the second plenum chamber hole, (ff) the seal may be permanently bonded to the corresponding of the first conduit connector and the second conduit connector, (gg) the seal may be(i) The positioning and stabilizing structure may be made of silicone, (hh) the positioning and stabilizing structure may include a pair of upper ties, each of which is constructed and positioned such that in use at least a portion of the upper tie rests in a region of the patient's head above the upper point of the base of the ears of the patient's head, and the positioning and stabilizing structure may include a pair of lower ties, each of which is constructed and positioned such that in use at least a portion of the lower tie rests in a region of the patient's head below the lower point of the base of the ears of the patient's head, (ii) each of the first conduit connector and the second conduit connector may include a lower tie connector configured to connect to either of the corresponding lower ties, (jj) the clip may releasably connect each of the lower ties to either of the corresponding lower tie connectors, (kk) the clip may include a magnet, and (ll) the patient interface may further include a pair of lower tie tabs configured to connect to either of the corresponding lower ties, and each of the first conduit connector and the second conduit connector may further include a flange configured to connect to either of the corresponding lower tie tabs (mm) Each flange may further include a flange opening and a recess, each lower tie tab may further include a tab connector configured to join each lower tie tab to the corresponding flange by passing through the corresponding flange opening and engaging with the corresponding recess, (nn) The patient interface may further include a clip configured to connect to each lower tie, each lower tie tab may further include a clip receiver configured to detachably connect to the corresponding clip to which the lower tie is connected, (oo) Each clip and each clip receiver may include a magnet oriented and charged to facilitate a detachable connection, (pp) Each clip receiver may include a notch, each clip may include a projection, each projection configured to engage with the corresponding notch to restrict rotation of the clip relative to the corresponding clip receiver, (qq) Each of the first conduit connector and the second conduit connector may connect the first conduit connector and the second conduit connector,The first and second tabs may further include a first tab and a second tab that are releasably connected to the plenum chamber in a first plenum chamber opening and a second plenum chamber opening, respectively, (rr) the first tab and the second tab may be configured such that the first conduit connector and the second conduit connector can only be connected to the plenum chamber by engaging the first tab with the plenum chamber and then engaging the second tab with the plenum chamber, (ss) the first tab and the second tab may be configured such that the first conduit connector and the second conduit connector can only be connected to the plenum chamber by engaging the first tab with the plenum chamber and then engaging the second tab with the plenum chamber After disengaging, the first tab may be configured to be disconnected from the plenum chamber only by disengaging the first tab from the plenum chamber, and the plenum chamber may further include slots proximal to the first plenum chamber hole and the second plenum chamber hole, and the first tab of the first conduit connector and the second conduit connector may be configured to engage with a slot coupled to the corresponding of the first plenum chamber hole and the second plenum chamber hole, each of the first conduit connector and the second conduit connector The first tabs of the first conduit connector and the second conduit connector may be rotatable about the corresponding slot when the first tabs of the first conduit connector and the second conduit connector are engaged with the corresponding slot, and the plenum chamber may further include a stopper proximal to the first plenum chamber hole and the second plenum chamber hole, and the second tabs of the first conduit connector and the second conduit connector may further include a catch, the catch snap-fitting with the stopper which is engaged with the corresponding of the first plenum chamber hole and the second plenum chamber hole (vv) The second tabs of the first conduit connector and the second conduit connector may be flexible, (ww) Each of the first conduit connector and the second conduit connector may further include gaps on both sides of the corresponding second tab, thereby allowing the second tab to be cantilevered from each of the first conduit connector and the second conduit connector, (xx) The seal-forming structure may include a nasal portion configured to seal around the patient's nostrils and a mouth portion configured to seal around the patient's mouth, (yy) The seal-forming structure may include,The patient interface may include a nasal opening configured to provide pneumatic communication between the patient's nostrils and the patient interface chamber, and the sealing structure may include a mouth opening configured to provide pneumatic communication between the patient's mouth and the patient interface chamber, (zz) the patient interface may include a connection port housing and a connection port connected to the connection port housing, each of which has a first conduit and a second conduit in pneumatic communication with the connection port housing, the connection port is connected to the treatment pressure, The (aaa) connection port may include an elbow, the (bbb) connection port may include at least one vent, the (ccc) connection port may be rotatably connected to a connection port housing, and / or the (ddd) connection port and connection port housing may be configured to be positioned above the patient's head when in use.

[0082] Another aspect of the present technology relates to a respiratory therapy system which may include: a patient interface as described in any of the embodiments of the preceding three sections; a respiratory pressure therapy device configured to generate an airflow at therapeutic pressure; and an air circuit configured to direct the airflow at therapeutic pressure from the respiratory pressure therapy device to the patient interface.

[0083] 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.

[0084] One embodiment of this technology is a method for manufacturing an apparatus.

[0085] 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.

[0086] One embodiment of this technology is a portable RPT device that can be carried by a person (for example, around their home).

[0087] 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.

[0088] The methods, systems, devices, and apparatus described may be embodied in a way that enables improvements in the functionality of processors (e.g., processors of computers for specific purposes, respiratory monitors, and / or respiratory therapy devices). Furthermore, the methods, systems, devices, and apparatus described may enable improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions (e.g., sleep-disordered breathing).

[0089] 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.

[0090] Other features of this technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawing]

[0091] 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:

[0092] 4.1 Treatment System [Figure 1A]Figure 1A shows a system including 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 patient 1000 along an air circuit 4170. A bedmate 1100 is also shown. The patient is sleeping in a supine sleeping position. [Figure 1B] Figure 1B shows a system including patient 1000 wearing patient interface 3000. This system takes the form of a nasal mask and receives positive-pressure air supplied from RPT device 4000. The air from the RPT device is humidified by humidifier 5000 and travels to patient 1000 along air circuit 4170. [Figure 1C] Figure 1C shows a system including 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 patient 1000 along an air circuit 4170. The patient is sleeping in a lateral sleeping position.

[0093] 4.2 Anatomical Structure of the Respiratory System and Face [Figure 2A] Figure 2A shows an overview of the human respiratory system, including the nasal cavity and oral cavity, larynx, vocal cord folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] Figure 2B 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] Figure 2C 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. Superior, inferior, radially medial, and radially lateral directions are also indicated. [Figure 2D]Figure 2D is a lateral view of the head including several features of surface anatomical structures, including the glabella, selion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, ala apex, suprasilis and subrasilis. Superior and inferior, and anterior and posterior directions are also indicated. [Figure 2E] Figure 2E is a further lateral view of the head. The approximate locations of the Frankfort horizontal and nasolabial angles are indicated. The coronal plane is also shown. [Figure 2F] Figure 2F 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] Figure 2G is a lateral view of the surface features of the nose. [Figure 2H] Figure 2H shows the subcutaneous structure of the nose, including the lateral nasal cartilage, nasal septum 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] Figure 2I shows a mid-nasal incision located approximately a few millimeters from the midline sagittal plane, particularly showing the nasal septum cartilage and the medial crura of the greater alar cartilage. [Figure 2J] Figure 2J is a frontal view of the skull, including the frontal, nasal, and zygomatic bones. The nasal conchae are shown together with the maxilla and mandible. [Figure 2K] Figure 2K is a lateral view of the skull showing the external shape of the head surface and some 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] Figure 2L shows the anterolateral aspect of the nose.

[0094] 4.3 Patient Interface [Figure 3A] Figure 3A shows a patient interface in the form of a nasal mask according to one embodiment of this technology. [Figure 3B]Figure 3B 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 curvature shown in 3C. [Figure 3C] Figure 3C 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] Figure 3D 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] Figure 3E 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] Figure 3F 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] Figure 3G shows a mask cushion containing two pillows. The outer surface of the cushion is shown. The edges of the surface are shown. The dome region and saddle region are shown. [Figure 3H] Figure 3H shows a cushion for the mask. The outer surface of the cushion is shown. The edges of the surface are shown. The path on the surface between point A and point B is shown. The straight-line distance between A and B is shown. Two saddle regions and a dome region are shown. [Figure 3I] Figure 3I shows the surface of the structure, which contains one-dimensional holes. The planar curves shown form the boundaries of the one-dimensional holes. [Figure 3J] Figure 3J 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 3K is a perspective view of the structure in Figure 3I, including two-dimensional and one-dimensional holes. The surface that borders the two-dimensional holes in the structure in Figure 3I is also shown. [Figure 3L] Figure 3L shows a mask with an inflatable bladder that acts as a cushion. [Figure 3M] Figure 3M is a cross-sectional view of the mask shown in Figure 3L, revealing the inner surface of the bladder. The inner surface defines the two-dimensional holes within the mask. [Figure 3N] Figure 3N shows a further cross-section through the mask in Figure 3L. The inner surface is also illustrated. [Figure 3O] Figure 3O illustrates the left-hand rule. [Figure 3P] Figure 3P illustrates the right-hand rule. [Figure 3Q] Figure 3Q shows the left ear, including the left auricle spiral. [Figure 3R] Figure 3R shows the right ear, including the right ear spiral. [Figure 3S] Figure 3S shows a right-handed spiral. [Figure 3T] Figure 3T 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] Figure 3U is a diagram of the plenum chamber 3200 showing the median sagittal plane and the central contact surface. [Figure 3V] Figure 3V is a rear view of the plenum chamber in Figure 3U. 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 3W is a cross-sectional view through the plenum chamber shown in Figure 3V, and this cross-section is 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 only the cushion of the plenum chamber 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 3X shows the plenum chamber 3200 of Figure 3U 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 surface" when the plenum chamber is in the position for use. In Figure 3X, the plenum chamber 3200 is part of a nasal mask, with the upper point 3220 resting approximately on the serion and the lower point 3230 resting on the upper lip.

[0095] 4.4 RPT Devices [Figure 4A] An RPT device 4000 conforming to one form of this technology is shown. [Figure 4B] This is a schematic diagram of the pneumatic path of an RPT device 4000 according to one embodiment of this technology. The upstream and downstream directions are indicated with respect to the blower and the patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items placed in the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 4C] This is a schematic diagram of the electrical components of an RPT device 4000 according to one aspect of this technology.

[0096] 4.5 Humidifier [Figure 5A] Figure 5A is an isometric view of a humidifier according to one embodiment of this technology. [Figure 5B] Figure 5B is an isometric view of a humidifier according to one embodiment of this technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 5C] Figure 5C is a schematic diagram of a humidifier according to one embodiment of this technology.

[0097] 4.6 Respiratory waveform [Figure 6]Figure 6 shows a model of a typical human respiratory waveform during sleep.

[0098] 4.7 Examples of Patient Interfaces Using This Technology [Figure 7] Figure 7 is a front view of a patient interface according to one embodiment of this technology. [Figure 8] Figure 8 is a rear perspective view of a patient interface according to one embodiment of this technology. [Figure 9] Figure 9 is a lower view of a patient interface according to one embodiment of this technology. [Figure 10] Figure 10 is a front view of a patient interface according to one embodiment of this technology. [Figure 11] Figure 11 is a rear view of a patient interface according to one embodiment of this technology. [Figure 12] Figure 12 is a cross-sectional view of a patient interface according to one embodiment of the present technology, taken through line 12-12 in Figure 11. [Figure 13] Figure 13 is a side view of a patient interface according to one embodiment of this technology. [Figure 14] Figure 14 is a cross-sectional view of a patient interface according to one embodiment of the present technology, taken through lines 14, 15-14, and 15 in Figure 13. [Figure 15] Figure 15 is a cross-sectional view of a patient interface according to one embodiment of the present technology, taken through lines 14, 15-14, and 15 in Figure 13. [Figure 16] Figure 16 is a front perspective view of a patient interface according to one embodiment of this technology. [Figure 17] Figure 17 is a rear perspective view of a patient interface according to one embodiment of this technology. [Figure 18] Figure 18 is an overhead view of a patient interface according to one embodiment of this technology. [Figure 19] Figure 19 is a front perspective view of a patient interface subassembly according to one embodiment of this technology. [Figure 20]Figure 20 is a front view of a patient interface subassembly according to one embodiment of this technology. [Figure 21] Figure 21 is a rear perspective view of a patient interface subassembly according to one embodiment of this technology. [Figure 22] Figure 22 is a rear view of a subassembly of a patient interface according to one embodiment of this technology. [Figure 23] Figure 23 is a cross-sectional view of a subassembly of a patient interface according to one embodiment of the present technology, taken through line 23-23 in Figure 22. [Figure 24] Figure 24 is a side view of a subassembly of a patient interface according to one embodiment of this technology. [Figure 25] Figure 25 is a front perspective view of a conduit connector for a patient interface according to one embodiment of this technology. [Figure 26] Figure 26 is a rear perspective view of a conduit connector for a patient interface according to one embodiment of this technology. [Figure 27] Figure 27 is a side perspective view of a conduit connector for a patient interface according to one embodiment of this technology. [Figure 28] Figure 28 is an overhead view of a conduit connector for a patient interface according to one embodiment of this technology. [Figure 29] Figure 29 is a cross-sectional view of a conduit connector for a patient interface according to one embodiment of the present technology, taken through lines 29, 30-29, 30 in Figure 28. [Figure 30] Figure 30 is a cross-sectional view of a conduit connector for a patient interface according to one embodiment of the present technology, taken through lines 29, 30-29, 30 in Figure 28. [Figure 31] Figure 31 is a front perspective view of a conduit connector for a patient interface according to one embodiment of this technology. [Figure 32] Figure 32 is a front perspective view of a patient interface according to one embodiment of this technology. [Figure 33] Figure 33 is a front view of a patient interface according to one embodiment of this technology. [Figure 34] Figure 34 is a front perspective view of a patient interface according to one embodiment of this technology, while it is being worn by a patient. [Figure 35] Figure 35 is a side view of a patient interface according to one embodiment of this technology, when it is being worn by a patient. [Figure 36] Figure 36 is a front view of a patient interface according to one embodiment of this technology, while it is being worn by a patient. [Figure 37] Figure 37 is an overhead perspective view of a connection port for a patient interface according to one embodiment of this technology. [Figure 38] Figure 38 is a downward perspective view of a connection port for a patient interface according to one embodiment of this technology. [Figure 39] Figure 39 is a front perspective view of a patient interface according to one embodiment of this technology. [Figure 40] Figure 40 is a rear perspective view of a patient interface according to one embodiment of this technology. [Figure 41] Figure 41 is a lower view of a patient interface according to one embodiment of this technology. [Figure 42] Figure 42 is a front view of a patient interface according to one embodiment of this technology. [Figure 43] Figure 43 is a rear view of a patient interface according to one embodiment of this technology. [Figure 44] Figure 44 is a cross-sectional view of a patient interface according to one embodiment of the present technology, taken through line 44-44 in Figure 43. [Figure 45] Figure 45 is a side view of a patient interface according to one embodiment of this technology. [Figure 46] Figure 46 is a cross-sectional view of a patient interface according to one embodiment of the present technology, taken through lines 46, 47-46, and 47 in Figure 45. [Figure 47] Figure 47 is a cross-sectional view of a patient interface according to one embodiment of the present technology, taken through lines 46, 47-46, and 47 in Figure 45. [Figure 48]Figure 48 is a front perspective view of a patient interface according to one embodiment of this technology. [Figure 49] Figure 49 is a rear perspective view of a patient interface according to one embodiment of this technology. [Figure 50] Figure 50 is an overhead view of a patient interface according to one embodiment of this technology. [Figure 51] Figure 51 is a front perspective view of a patient interface subassembly according to one embodiment of the present technology. [Figure 52] Figure 52 is a front view of a subassembly of a patient interface according to one embodiment of this technology. [Figure 53] Figure 53 is a rear perspective view of a patient interface subassembly according to one embodiment of this technology. [Figure 54] Figure 54 is a rear view of a subassembly of a patient interface according to one embodiment of this technology. [Figure 55] Figure 55 is a cross-sectional view of a subassembly of a patient interface according to one embodiment of the present technology, taken through line 55-55 in Figure 54. [Figure 56] Figure 56 is a rear perspective view of a conduit connector for a patient interface according to one embodiment of this technology. [Figure 57] Figure 57 is an exploded rear perspective view of a conduit connector for a patient interface according to one embodiment of this technology. [Figure 58] Figure 58 is a disassembled front perspective view of a conduit connector for a patient interface according to one embodiment of this technology. [Figure 59] Figure 59 is an overhead view of a conduit connector for a patient interface according to one embodiment of this technology. [Figure 60] Figure 60 is a cross-sectional view of a conduit connector for a patient interface according to one embodiment of the present technology, taken through lines 59, 60-59, 60 of Figure 58. [Figure 61] Figure 61 is a cross-sectional view of a conduit connector for a patient interface according to one embodiment of the present technology, taken through lines 59, 60-59, 60 of Figure 58. [Figure 62] Figure 62 is a front perspective view of a conduit connector for a patient interface according to one embodiment of this technology. [Figure 63] Figure 63 is a cross-sectional view of a conduit connector for joining a patient interface to a conduit according to one embodiment of this technology. [Figure 64] Figure 64 is a front view of a patient interface according to one embodiment of this technology. [Figure 65] Figure 65 is a front perspective view of a patient interface according to one embodiment of this technology. [Figure 66] Figure 66 is a rear view of a positioning and stabilization structure according to one embodiment of this technology. [Figure 67] Figure 67 is a perspective view of a clip according to one embodiment of this technology. [Figure 68] Figure 68 is a perspective view of a clip according to one embodiment of this technology. [Modes for carrying out the invention]

[0099] 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.

[0100] 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.

[0101] 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.

[0102] In certain embodiments of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0103] In certain embodiments of this technology, mouth breathing is restricted, limited, or prevented.

[0104] 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.

[0105] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of this technology includes the following functional modes: 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. In some embodiments, the functional modes 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.

[0106] 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.

[0107] 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.

[0108] 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.

[0109] 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.

[0110] 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).

[0111] In one embodiment, the target seal formation region is located on the outer surface of the seal formation structure 3100.

[0112] In a specific embodiment of this technology, the seal-forming structure 3100 is made of a biocompatible material (e.g., silicone rubber).

[0113] The seal-forming structure 3100 according to this technology may be made of a soft, flexible, and elastic material (for example, silicone).

[0114] 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.

[0115] 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.

[0116] 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 about 1 mm (e.g., about 0.25 mm to about 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.

[0117] In one embodiment, the seal-forming structure may include a compression seal or a gasket seal. During use, the compression seal or gasket seal is constructed and positioned such that it is compressed, for example, due to elastic tension in the positioning and stabilizing structure.

[0118] 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.

[0119] In one embodiment, the seal-forming structure includes a region having an adhesive surface or bonding surface.

[0120] 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.

[0121] 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.

[0122] 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.

[0123] 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.

[0124] 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.

[0125] 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.

[0126] 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.

[0127] 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.

[0128] 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.

[0129] 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.

[0130] 5.3.1.7 Seal-forming structure 3100 of this technology The seal-forming structure 3100 according to this embodiment of the technology can separately seal the area around the patient's nostrils and mouth (i.e., mouth-nose).

[0131] The seal-forming structure 3100 may include a nasal portion 3101 having a nasal portion opening 3103 for sealing the patient's nostrils. In the described embodiment, one nasal portion opening 3103 is provided to provide airflow to both of the patient's nostrils. In another embodiment, the nasal portion opening 3103 may be divided into two separate openings. Each of these two separate openings corresponds to one of the patient's nostrils. A portion of the nasal portion 3101 may be separated into two separate openings.

[0132] The seal-forming structure 3100 may include a mouth portion 3102 having a mouth portion opening 3104 for sealing the patient's mouth.

[0133] The seal-forming structure 3100 can at least partially form a patient interface chamber 3001 that is pressurized by airflow. The plenum chamber 3200 may be joined with the seal-forming structure 3100 to further form the patient interface chamber 3001.

[0134] 5.3.2 Plenum Chamber The plenum chamber 3200 has a perimeter shape that is complementary to the surface contour of an average human face in the area where a seal is formed during use. During use, the peripheral edge of the plenum chamber 3200 is positioned close to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire perimeter 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 material piece.

[0135] 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.

[0136] 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.

[0137] 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.

[0138] The plenum chamber 3200 according to embodiments of this technology may include plenum chamber holes 3201 on each side. The plenum chamber 3201 may provide pneumatic communication between the conduit connector 3800 (described in more detail below) and the patient interface chamber 3001. The plenum chamber 3200 may include a connecting rim 3202 around each plenum chamber hole 3201. The connecting rim 3202 may facilitate mechanical connection (e.g., snap-fit ​​or friction-fit) with each conduit connector. The plenum chamber 3200 may be constructed of a material with sufficient rigidity so that auditory and / or tactile feedback can be provided to the patient when the conduit connector 3800 is connected to or removed from the plenum chamber 3200.

[0139] The seal-forming structure 3100 may be connected to the plenum chamber 3200. The connection may be permanent, or the seal-forming structure 3100 may be removable from the plenum chamber 3200. The seal-forming structure 3100 may be overmolded over the plenum chamber 3200. The seal-forming structure 3100 and the plenum chamber 3200 may be joined by a mechanical interlock. In the mechanical interlock, no chemical bond is formed between the plenum chamber 3200 and the seal-forming structure 3100.

[0140] 5.3.3 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.

[0141] 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.

[0142] In one embodiment, the positioning and stabilizing structure 3300 provides sufficient holding force to overcome the attractive force on the patient interface 3000.

[0143] In one embodiment, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive effects on the patient interface 3000 (for example, those resulting from tube dragging or accidental interference with the patient interface).

[0144] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided, configured to be worn by a patient while sleeping. In one embodiment, the positioning and stabilizing structure 3300 has an inconspicuous shape or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0145] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a supine position with the posterior region of the patient's head resting on a pillow.

[0146] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a lateral position with the side of the patient's head resting on a pillow.

[0147] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a release portion located between the front portion and the rear portion of the positioning and stabilizing structure 3300. This release portion is not compressible and may be, for example, a flexible or flimsy strap. The release portion is constructed and positioned so as to prevent a situation in which, when a patient lies down with their head on a pillow, the presence of the release portion transmits force to the rear along the positioning and stabilizing structure 3300, thereby interfering with the seal.

[0148] 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.

[0149] 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 close contact with a portion of the patient's face. In one embodiment, the strap may be configured as a tie.

[0150] 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 a point above the base of the ear, covering a portion of the parietal bone without covering the occipital bone.

[0151] 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 subauricular base of the lower part of the patient's head and covers or rests on the lower part of the occipital bone of the patient's head.

[0152] 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.

[0153] 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.

[0154] 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.

[0155] In certain embodiments of this technology, a system is provided comprising more than one positioning and stabilizing structure 3300. Each positioning and stabilizing structure 3300 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 another form that is suitable for a small head rather than a large head.

[0156] The positioning and stabilization structure 3300 may include clips 3301 for securing each tie to the conduit connector 3800, for example, as shown in Figures 32 to 36. Magnets 3305 with opposite polarity are positioned on both the clips 3301 and the conduit connector 3800 to facilitate connection between them. The clips 3301 may also include a crossbar 3306. Downward ties 3303 are provided around the crossbar 3306 to secure the clips 3301 to the crossbar 3306.

[0157] Figure 66 shows an exemplary positioning and stabilizing structure 3300, which may include an upper tie 3302, a lower tie 3303, and a rear portion 3304.

[0158] 5.3.4 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).

[0159] In a particular 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.

[0160] One form of the ventilation section 3400 according to this technology includes a plurality of holes (for example, about 20 to 80 holes, or about 40 to 60 holes, or about 45 to 55 holes).

[0161] 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).

[0162] Figures 32 and 33 show one embodiment of a ventilation section 3400 provided on a connection port 3600. Modifications of these embodiments may include ventilation 3400 from the connection port 3600.

[0163] The conduit connector 3800, described in more detail below, may also include a ventilation feature.

[0164] 5.3.5 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).

[0165] 5.3.6 Connection Ports The connection port 3600 enables connection to the air circuit 4170. In one embodiment of this technology, the connection port 3600 may be connected to a connection port housing 3903. The connection port 3600 may be swivelable relative to the connection port housing 3903, and the connection portion to the air circuit 4170 may also be swivelable.

[0166] The connection port 3600 and the connection port housing 3903 may be positioned above the patient's head during use.

[0167] Figures 37 and 38 show connection ports 3600 for patient interface 6000 according to another embodiment of the present technology. While the present technology is described in relation to patient interface 6000, it should be understood that the technology is not limited to such specific embodiments and can be adapted for use with other suitable interface configurations and types.

[0168] In the illustrated embodiment, the connection port 3600 takes the form of a connection port with a structure and arrangement configuration that provides a releaseable connection between the patient interface 6000 and the air circuit 4170.

[0169] The connection port 3600 includes an elbow assembly 7700 configured to connect to the air circuit 4170 (for example, via a swivel connector 7790) and a ring member 7900 configured to connect to the patient interface 6000. As will be described in more detail below, the elbow assembly 7700 is repeatedly engageable and detachably disengaged (i.e., connectable and disconnectable) with respect to the ring member 7900, thereby facilitating a releasable or separable connection between the remainder of the patient interface 3000 and the air circuit 4170.

[0170] 5.3.6.1 Elbow Assembly The elbow assembly 7700 includes an elbow member 7710 having a first end and a second end. In the illustrated embodiment, the elbow member 7710 includes a 90° bend, so the first end is generally perpendicular to the second end (i.e., the central axis of the first end is at a 90° angle with respect to the central axis of the second end). However, it should be understood that the first and second ends may be arranged in a different configuration (for example, not perpendicular to each other).

[0171] A clip member 7730 is provided at the first end. In the illustrated embodiment, the clip member 7730 is constructed and arranged in such a way that a releaseable connection (e.g., a releaseable snap-fit ​​connection or a detachable snap-joint assembly with the ring member 7900) is obtained. The second end is provided with a swivel connector 7790 (e.g., a swivel connector 7790 permanently connected to the second end) adapted for connection to the air circuit 4170.

[0172] To allow exhaust gases to exit from the patient interface 3000, a plurality of vents 7720 (e.g., at least 10 vents, e.g., 10 to 20 vents) are provided along the rear wall of the elbow member 7710. As shown in the illustration, the vents 7720 are arranged in a row, but it should be understood that the vents may be arranged in other suitable manners (e.g., concentrically). In one embodiment, each vent 7720 may include an outer shape or taper along its length (e.g., each hole converges in the direction of the exhaled gas). However, each vent 7720 may have other suitable shapes for directing the exhaust or discharge gas. Furthermore, in the illustrated embodiment, the vents 7720 may be located on a portion of the rear wall that is generally flat or planar, so that the exit end of each vent is provided along a generally flat or planar surface. However, it should be understood that the ventilation holes 7720 may be provided on a portion of the elbow member 7710 having other shapes (circular or convex).

[0173] The clip member 7730 includes a pair of elastic quick-release pinch arms 7740 and a connecting portion 7760 that interconnects the pinch arms 7740 (i.e., the pinch arms 7740 are provided at each end of the connecting portion 7760).

[0174] Each pinch arm 7740 includes a catch portion 7750 and a button or trigger portion 7780. The pinch arm 7740 is constructed and positioned to provide a releaseable snap-fit ​​connection or a detachable snap-fit ​​assembly with the ring member 7900 (for example, the catch portion 7750 is configured to deform or snap into a recess or undercut on the ring member 7900). The button portion 7780 is constructed and positioned to be pinched or tightened by hand, so that the catch portion 7750 can be bent, thereby separating or releasing the catch portion 7750 from the ring member 7900, and thus separating the elbow assembly 7700 from the ring member 7900.

[0175] Each catch portion 7750 includes a curved end, rib, or catch, constructed to provide a snap-fit ​​assembly with the ring member 7900. Each button or trigger portion 7780 includes a finger grip portion 7781 (for example, a recess adjacent to the free end of the pinch arm 7740).

[0176] In the illustrated embodiment, the clip member 7730 and the elbow member 7710 include separately molded parts (i.e., separate and distinct structures). These parts are then connected to each other (e.g., by a snap-fit ​​connection). For example, the clip member 7730 may include a material that is more flexible than the material of the elbow member 7710, so that the clip member 7730 can bend and connect onto the first end of the elbow member 7710. In one embodiment, a retaining arrangement configuration is provided to secure the clip member to the elbow member (e.g., a snap-fit ​​connection or a snap-joint assembly).

[0177] In the illustrated embodiment, the clip member 7730 includes an open-end configuration with a semi-flexible and generally semicircular connecting portion 7760, which allows the clip member 7730 to be connected to the elbow member 7710 (for example, in a manner similar to a circlip).

[0178] In one embodiment, the catch portion 7750 of the clip member 7730 can be biased inward, so that when the clip member 7730 is connected to the elbow member 7710, the catch portion 7750 is biased to grip the elbow member 7710, providing further resistance to removal from the elbow member 7710.

[0179] In the illustrated embodiment, the elbow member 7710 and the clip member 7730 provide a two-part assembly or structure. An exemplary advantage of such a two-part structure is that it allows for manufacturing with fewer constraints on the material. For example, because the clip member 7730 and the elbow member 7710 include separately molded parts, the coded dependency between the clip member 7730 and the elbow member 7710 is reduced (for example, the clip member 7730 is no longer constrained by the material of the elbow member 7710). In one embodiment, the clip member 7730 and the elbow member 7710 contain different materials and / or different material properties. In one embodiment, the clip member 7730 and the elbow member 7710 are not molded as a single piece from the same material.

[0180] In one embodiment, the elbow member 7710 may include a material (e.g., polycarbonate) that is more rigid than the material of the clip member 7730 (e.g., nylon-12). The material of the clip member 7730 (e.g., nylon-12) may be relatively flexible and robust (e.g., the pinch arm is more flexible, it is wear-resistant, and it maintains the connection to the elbow member). The material of the elbow member 7710 (e.g., polycarbonate) may be relatively rigid (e.g., it is wear-resistant, it is transparent and therefore easy to clean, and it is easy to manufacture).

[0181] Furthermore, because it is a two-part structure, the complexity of the geometry of each part can be reduced, which in turn can simplify the setup process during manufacturing and assembly.

[0182] In the illustrated embodiment, the clip member 7730 is structured and arranged in such a way that a detachable connection (e.g., a snap-fit ​​connection with the elbow member 7710) is obtained. Such a detachable or detachable arrangement may be advantageous because it facilitates cleaning when the clip member 7730 and the elbow member 7710 are separated.

[0183] In another embodiment, the clip member 7730 does not have to be detachably connected to the elbow member 7710 (for example, the clip member may be permanently connected to the elbow member). Such a non-detachable arrangement may be advantageous because it reduces the likelihood of the clip member being lost or broken. Since the clip member is outside the air passage, thorough cleaning is not as critical as, for example, a component exposed to the air passage.

[0184] In one embodiment, the clip member 7730 and the elbow member 7710 may include separately molded parts. These separately molded parts may then be permanently interconnected such that the clip member 7730 cannot be separated from the elbow member 7710. Any suitable means may be used for the permanent joining or connection of the clip member and the elbow member.

[0185] In one embodiment, the clip member 7730 and the elbow member 7710 can be welded or bonded to each other (for example, they can be welded to each other by ultrasonic welding). For example, after connecting the clip member 7730 to the elbow member 7710 as described above, one or more portions of the connection portion 7760 of the clip member 7730 (for example, the central portion) can be welded or bonded to the elbow member 7710 to permanently fix the clip member to the elbow member. This connection makes it possible to obtain sufficient torsion (and torsional resistance) at the connection for the operation of the pinch arm 7740.

[0186] Alternatively, the structure of the elbow assembly may be such that the structure of the elbow member and / or clip member makes disassembly difficult or complex, while allowing the clip member to be easily attached to the elbow member. In such an elbow assembly where the elbow member and clip member are manufactured separately, the desired advantages can be achieved (e.g., reduced constraints on material selection) while avoiding further welding or bonding work when fixing the clip member to the elbow member.

[0187] The ring member 7900 is configured to be removably and securely fixed in the opening or aperture of the connection port housing 3903. The elbow assembly 7700 is releasably connected to the ring member 7900 via the pinch arm 7740 (e.g., a snap fit or snap joint assembly).

[0188] The connection port 3600 allows the air circuit 4170 to be disconnected from the patient interface (for example, improving the disconnection of tube drag on the patient interface to avoid instability).

[0189] One form of disengagement is provided by a pinch arm 7740 that forms a swivel connection, allowing the elbow assembly 7700 to rotate freely 360° relative to the ring member 7900. Another form of disengagement is provided by the swivel connector 7790, which allows for 360° free rotation of the swivel connector 7790 relative to the elbow member 7710 (and connection of the air circuit 4170 to the swivel connector 7790).

[0190] 5.3.7 Forehead support In one embodiment, the patient interface 3000 includes a forehead support portion 3700.

[0191] The embodiments of the patient interface of this technology shown in Figures 7 to 36 do not include a forehead support. Modified versions of the patient interface of this technology may include a forehead support.

[0192] 5.3.8 Conduit The patient interface 3000 according to an embodiment of this technology may include a conduit 3900 for obtaining pressurized flow from the connection port 3600 to the patient interface chamber 3001. The conduit 3900 may be joined in the connection port housing 3903 above the patient's head and may pass along the side of the patient's head between the corresponding eyes and ears of the patient. The conduit 3900 may be connected to the plenum chamber 3200 via a conduit connector 3800 to provide pressurized airflow to the patient interface chamber 3001, as described below.

[0193] The conduit 3900 may also enable stabilization and positioning of the seal-forming structure 3100 on the patient's face. Thus, the conduit 3900 may function similarly to a tie for the positioning and stabilization structure 3300. Therefore, the mechanical connection from the conduit 3900 to the conduit connector 3800 may be sufficient to transmit the tensile force in the conduit 3900 to the seal-forming structure 3100 through the conduit connector 3800.

[0194] Conduit 3900 may include features of a similar conduit disclosed in International Patent Publication WO2017 / 124155Al, which is incorporated herein by reference in its entirety. For example, conduit 3900 of this technology may include features of the headgear tube 3350 described in Figures 3A to 3L and related descriptions in this document.

[0195] By providing a sleeve 3901 to the conduit 3900, the patient's face can be protected from the conduit 3900 like a cushion. The sleeve 3901 may be removable. The sleeve 3901 may be made of a breathable material.

[0196] The conduit 3900 may also include a tie connector 3902 for facilitating connection to the tie of the positioning and stabilizing structure 3300.

[0197] 5.3.9 Conduit Connectors According to embodiments of this technology, the patient interface 3000 may include conduit connectors 3800. The conduit connectors 3800 connect conduits 3900 to the plenum chamber 3200, providing a flow of pressurized air to the patient interface chamber 3001. Each conduit connector 3800 may be formed together with a conduit connector housing 3801. The conduit connectors 3800 may provide other functions as described below (e.g., ventilation of the patient interface chamber 3001, connection to the positioning and stabilization structure 3300, and asphyxiation prevention by incorporating an asphyxiation prevention valve 3850).

[0198] Figures 7 to 18 show several diagrams of the conduit connector 3800 on the patient interface 3000 according to an embodiment of the present technology. Figures 25 to 31 show several diagrams of the conduit connector 3800 separated according to an embodiment of the present technology. Figures 32 to 36 show several diagrams of the complete patient interface 3000 with the conduit 3900 and positioning and stabilizing structure 3300 connected to the conduit connector 3800 according to an embodiment of the present technology.

[0199] Figures 7 to 18 illustrate how the conduit connectors 3800 are attached to the plenum chamber 3201 at the plenum chamber opening 3201. As can be understood, one conduit connector 3800 is provided on each side of the patient interface 3000, and each conduit connector 3800 connects to the plenum chamber opening 3201 at each corresponding side of the patient interface 3000. Each conduit connector 3800 may include a conduit connector mounting structure 3807 for connecting each conduit connector 3800 to each plenum chamber opening 3201 at a connecting rim 3202. This connection may be mechanical (e.g., snap-fit ​​or friction-fit). This connection may also be removable. The materials of the conduit connectors 3800 and the plenum chamber 3200 may be selected to facilitate the desired connection feature, respectively. For example, the materials of the conduit connector 3800 and the plenum chamber 3200 may be relatively rigid, respectively, to allow auditory and / or tactile feedback in relation to the snap-fit. The materials of the conduit connector 3800 and the plenum chamber 3200 may be different in at least one embodiment, or the materials may be the same. The conduit connector 3800 may be permanently connected to the plenum chamber 3200 in the plenum chamber hole 3201. For example, the conduit connector 3800 may be ultrasonically welded to the plenum chamber 3200 in the plenum chamber hole 3201. The connection between the conduit connector 3800 and the plenum chamber 3200 may be removable or permanent and may be designed to be robust enough to allow tension from the conduit 3900 to be transmitted to the plenum chamber 3200 (without interfering with the connection). This is because, as described above, the conduit connector 3800 can facilitate the positioning and stabilization of the seal-forming structure 3100 on the patient's head.

[0200] To improve the aesthetics of the patient interface 3000, the conduit connector 3800 may be mounted laterally to the plenum chamber 3200. As described above, by constructing the plenum chamber 3200 from a transparent or translucent material, the patient's facial features may be made visible. For example, by positioning the conduit connector 3800 laterally to the plenum chamber as shown in the illustrated embodiment, the patient's face can be viewed more clearly, and this arrangement improves the aesthetics of the patient interface 3000. This is in contrast to alternative designs where the patient's face is obstructed because the elbow and air circuit can be joined to the center of the plenum chamber 3200.

[0201] The conduit connector 3800 and the plenum chamber hole 3201 may also be positioned such that at least a portion of the conduit connector housing 3801 extends into the patient interface chamber 3001. This configuration reduces dead space within the patient interface chamber 3001 by utilizing the volume occupied by the conduit connector 3800 within the patient interface chamber 3001. Thus, the volume of the conduit connector 3800 that extends outward from the patient interface 3000 is reduced. This can be advantageous because it reduces the amount of extra structure that is likely to interfere with bedding and results in a more attractive appearance from the patient's perspective.

[0202] Each conduit connector 3800 may also include a conduit connection end 3802 that connects to each conduit 3900. The connection between the conduit 3900 and the conduit connector 3800 at the conduit connection end 3802 may be removable or permanent. A conduit connector inlet hole 3803 may be formed in the conduit connector housing 3801 at the conduit connection end 3802 to receive pressurized airflow. The conduit connector 3800 may include a structure (e.g., an undercut) to facilitate a removable snap-fit ​​connection with the corresponding conduit 3900. Each conduit 3900 may include a relatively rigid structure at its end that connects to the conduit connector 3800 to facilitate such a connection. The conduit connector 3800 may be joined to the conduit 3900 by friction fit. Here again, as described above, the conduit 3900 provides positioning and stabilization functions for installing the seal-forming structure in a therapeutically effective sealed position on the patient's face. Therefore, the connection between the conduit 3900 and the conduit connector 3800 at the conduit connection end 3802, and the transmission of tensile force from the conduit 3900 to the conduit connector 3800 (without interfering with the connection between the conduit 3900 and the conduit connector 3800 at the conduit connection end 3802) can be sufficiently and reliably achieved.

[0203] The ventilation function of the patient interface 3000 can also be obtained by the conduit connector 3800. The conduit connector housing 3801 may include a conduit connector ventilation inlet 3832 that is pneumatically connected to the patient interface chamber 3001 during the assembly of the patient interface 3000. The conduit connector housing 3801 may also include at least one conduit connector vent hole 3831. As can be seen from the illustrated embodiment, each conduit connector housing 3801 includes a plurality of conduit connector vent holes 3831. The conduit connector housing 3801 may also include a baffle 3805 to prevent air that has entered the patient interface chamber 3001 through the conduit connector outlet hole 3804 from escaping directly from the conduit connector vent hole(s) 3831. As a result, it becomes possible to appropriately mix the newly introduced air and the existing air in the patient interface chamber 3001, thereby improving the extrusion of carbon dioxide and increasing the amount of fresh air provided to the patient for breathing. The conduit connector housing 3801 may also include at least one conduit connector ventilation spacer 3833. FIGS. 25 to 31 show a plurality of conduit connector ventilation spacers 3833 that provide a passage for exhaled gas to escape from the conduit connector 3800 to the surroundings through the conduit connector ventilation outlet 3830 in these embodiments. The conduit connector ventilation spacer 3833 may be distributed around a part of the edge of the conduit connector housing 3801. The conduit connector ventilation spacer 3833 may maintain a gap between a part of the conduit connector housing 3801 and the plenum chamber 3200 for the conduit connector ventilation outlet 3830.

[0204] The conduit connector housing 3801 may also include a diffuser cavity 3871 that may contain a diffuser material (not shown). The diffuser material may be enclosed within the diffuser cavity 3871 by a diffuser cover 3870. The diffuser cover 3870 may be permanently attached to the conduit connector housing 3801, so that the patient cannot change the diffuser material if it becomes blocked due to contaminants. In this embodiment, the diffuser cover 3870 may be ultrasonically welded to the conduit connector housing 3801. Alternatively, the diffuser cover 3870 may be removably attached to the conduit connector housing 3801, for example, via snap fit or friction fit, so that the patient can replace the diffuser material.

[0205] As shown in FIGS. 32 to 36, the conduit connector 3800 can also provide a connection to the tie of the positioning and stabilization structure 3300. The lower tie can be joined to the conduit connector 3800 by a clip 3301. The clip 3301 and the conduit connector 3800 may include magnets with opposite polarities for facilitating connection. The connection between the tie of the positioning and stabilization structure 3300 and the conduit connector 3800 may be releasable. The tension from the lower tie of the positioning and stabilization structure 3300 can bias the lower part of the seal formation structure 3100 to make a sealed engagement with the patient's face (e.g., around the mouth). Although not shown in FIGS. 25 to 31, the structure for connecting the clip 3301 can be formed on the diffuser cover 3870. Alternatively, the connection structure to the clip 3301 may be formed directly on the conduit connector housing 3801.

[0206] FIGS. 39 to 66 show another example of the present technology that includes features similar to those of the embodiments shown in FIGS. 7 to 36. The examples in FIGS. 39 to 66 also include features different from those of the embodiments shown in FIGS. 7 to 36.

[0207] As can be seen from the embodiments shown in Figures 39 to 66, the plenum chamber 3200 includes a plurality of plenum chamber vents 3401. These plenum chamber vents 3401 allow gases (including exhaled carbon dioxide) released from the patient interface chamber 3001 into the surroundings to be expelled. Therefore, the size, shape, and number of the plenum chamber vents 3401 are such that carbon dioxide can be sufficiently pushed out, and thus the conduit connector 3800 in this embodiment does not include any of the ventilation structures present in the above example (i.e., conduit connector vent outlet 3830, conduit connector vent hole 3831, conduit connector vent inlet 3832, etc.).

[0208] In another embodiment, the conduit connector 3800 may include a conduit connector vent outlet 3830, a conduit connector vent hole 3831, a conduit connector vent inlet 3832, and a plurality of plenum chamber vent holes 3401 are also provided on the plenum chamber 3200. This arrangement configuration may be advantageous because it may allow for further and / or more diffused ventilation.

[0209] The conduit connector 3800 in this embodiment does not include an optional ventilation structure (i.e., a conduit connector ventilation outlet 3830), but in this case as well, for safety reasons, an anti-choking valve assembly 3850 is provided for each conduit connector 3800. Figures 46 and 47 show the movement of the anti-choking valve flap 3851 between an open position and a closed position, similar to the embodiment described above.

[0210] In the embodiments shown in Figures 39 to 66, the plenum chamber 3200 may not have a sealing structure on the plenum chamber hole 3201. In this embodiment, sealing between the conduit connector 3800 and the plenum chamber 3200 can be achieved by a conduit connector outlet seal 3861 joined around the outer circumference of the conduit connector outlet 3808. The conduit connector outlet seal 3861 may be made of an elastomer material (e.g., silicone) that deforms when it comes into contact with the connecting rim 3202 around each plenum chamber hole 3201. The conduit connector outlet seal 3861 can be overmolded onto the conduit connector outlet 3808. When the conduit connector 3800 is installed into the corresponding plenum chamber hole 3201, the conduit connector outlet seal 3861 deforms upon contact with the connecting rim 3202, thereby ensuring sealing between them. In this embodiment, the conduit connector outlet seal 3861 may extend around the entire conduit connector outlet 3808, or it may be provided only at one or more selected portions of the conduit connector outlet 3808.

[0211] Alternatively, a conduit connector outlet seal 3861 may be provided such that the connecting rim 3202 of each plenum chamber hole 3201 contacts and deforms the conduit connector outlet 3808 of each conduit connector 3800. In this embodiment, the conduit connector outlet seal 3861 may extend around the entire plenum chamber hole 3201, or it may be provided only at one or more selected locations around the plenum chamber hole 3201.

[0212] In yet another embodiment, there is no deformable sealing component between the conduit connector 3800 and the connecting rim 3202 of the corresponding plenum chamber hole 3201. Therefore, leakage may occur in this alternative example, or the tolerance between the conduit connector 3800 and the connecting rim 3202 of the corresponding plenum chamber hole 3201 may be so small that there is little to no leakage.

[0213] In the embodiments shown in Figures 39 to 66, the conduit connector 3800 may be configured to provide a connection that can be opened to the plenum chamber 3200 in the corresponding plenum chamber hole 3201. The conduit connector 3800 may be made of a relatively rigid plastic material (e.g., polycarbonate) to facilitate the connection described below.

[0214] A slot 3203 and a retaining element 3204 may be formed on the plenum chamber 3200 in each plenum chamber hole 3201 so as to engage with the corresponding structure of the conduit connector 3800. The engagement process may be initiated by engaging a first tab 3890 with the slot 3203 from the front side of the plenum chamber 3200 (i.e., the side away from the patient during use). The first tab 3890 may be relatively rigid and, once engaged with the slot 3203, can act as a fulcrum, allowing the conduit connector 3800 to rotate around the slot 3203, thus completing the engagement process. The engagement process may be completed by a second tab 3891 having a catch 3892 that engages with the retaining element 3204 of the plenum chamber 3204. When the conduit connector 3800 rotates and engages with the plenum chamber 3200 in the corresponding plenum chamber hole 3201, the conduit connector outlet seal 3861 engages with the corresponding connecting rim 3202, thereby establishing a pneumatic seal. Furthermore, since the conduit connector outlet 3808 can extend at least partially through the corresponding plenum chamber hole 3201, gas can move between the patient interface chamber 3001 and the conduit connector 3800. Since the second tab 3891 may be flexible, a snap-fit ​​connection is established when the catch 3892 and the retainer 3204 engage. The reason this is beneficial to the patient is that the snap-fit ​​connection provides tactile and auditory feedback that the connection has been established. By providing a gap 3893 between one side of the second tab 3891 and the conduit connector outlet 3808, the second tab 3891 can be cantilevered, facilitating deformation during the engagement and disengagement processes.

[0215] The disengagement process is performed in the reverse order, first by disengaging the catch 3892 from the corresponding retaining ring 3204 by rotating the conduit connector 3800 forward in the direction away from the plenum chamber 3200. Since the second tab 3891 is flexible, when sufficient force is applied to the second tab, the second tab 3891 bends, and the catch 3892 disengages from the retaining ring 3204. Subsequently, the conduit connector 3800 is rotated further, and the first tab 3890 disengages from the slot 3203. During the disengagement process, the conduit connector outlet seal 3861 disengages from the corresponding connecting rim 3202, and the conduit connector outlet 3808 exits from the corresponding plenum chamber hole 3201.

[0216] When engaged, the conduit connector 3800 can protrude forward relative to the plenum chamber 3200, so that the conduit 3900 is oriented laterally away from the plenum chamber 3200. By positioning the conduit 3900 in front of the plenum chamber 3200, the conduit 3900 can maintain engagement without damage even when pulled away from the plenum chamber 3200 by lateral forces, and the force required to disengage the conduit connector 3800 and thus the conduit 3900 from the plenum chamber 3200 can also be reduced. Therefore, the conduit 3900 can be joined to the conduit connector 3800 with sufficient strength to withstand lateral disengagement, as will be further described below, and the conduit connector 3800 can be removed from the plenum chamber 3200 relatively easily (by rotating it out of the plenum chamber hole 3201 as described above). Since lateral forces are common during use (i.e., during sleep), such a configuration may be advantageous in typical applications. It is also advantageous if the patient interface 3000 can withstand these forces (without obstructing the connection between the conduit 3900 and the plenum chamber 3200 and thereby the gas flow). However, the forces that cause the disengagement process described above are not very common during sleep. Therefore, the first tab 3890 and the second tab 3891 can be designed so that engagement and disengagement with the slot 3203 and the retaining tab 3204 can be performed with relatively small forces in each direction, so that the patient can easily engage and disengage the conduit connector 3800. In this embodiment, the disengagement force can be reduced to 8-12 Newtons.

[0217] Furthermore, the force required to disengage the conduit connector 3800 is small enough that it can be disengaged by applying a forward force to the flange 3885 configured for magnetic fastening of the positioning and stabilizing structure 3300.

[0218] The conduit connector 3800 may also include a flange 3885 for connecting a lower tie 3303 to the conduit connector 3800 via a clip 3301. The flange 3885 may extend from the conduit connector 3800. The flange 3885 may be molded as a single piece with the conduit connector 3800. The flange 3885 may include a flange opening 3887 and a recess 3886 for receiving a tab connector 3884 of a lower tie tab 3880. To attach the lower tie tab 3880 to the flange 3885, the tab connector 3884 passes through the flange opening 3887 and engages in the recess 3886. The lower tie tab 3880 may include a clip receiver 3881. The clip receiver 3881 may house a magnet that allows for a releasable connection to a corresponding magnet in the clip 3301. The clip receiver 3881 may also engage with the overhang 3307 of the clip 3301 in order to keep the clip 3301 engaged with the lower tie tab 3880. Thus, the attraction between the magnet of the clip 3301 and the clip receiver 3881 provides the installation function, and the engagement of the overhang 3307 and the clip receiver 3881 ensures that the clip 3301 remains securely connected to the lower tie tab 3880. It should be understood that the connection between the clip 3301 and the lower tie tab 3880 can be released by applying a force sufficient to overcome the attractive force between the two magnets. The lower tie tab 3880 may also include a notch 3882.

[0219] The conduit 3900 can be permanently or removablely joined to the conduit connector 3802 at the conduit connector end 3802. Figure 63 shows one embodiment of a permanent connection in which an intermediate conduit connector inlet seal 3860 (for example, made of silicone) is molded around the conduit connector end 3802. The conduit 3900, which may similarly be made of silicone, is molded onto the intermediate conduit connector inlet seal 3860.

[0220] 5.3.10 Suffocation prevention valve In one embodiment, the patient interface 3000 includes an asphyxiation prevention valve. As can be seen from the embodiments shown in Figures 7 to 18 and Figures 25 to 31, each conduit connector 3800 may include an asphyxiation prevention valve assembly 3850. Thus, the patient interface 3000 may include two asphyxiation prevention valve assemblies 3850. Each asphyxiation prevention valve assembly 3850 may operate independently of each other (i.e., in response to the cessation of pressurized airflow). For example, if the pressurized airflow stops when the patient is lying on their side and one asphyxiation prevention valve assembly 3850 is blocked (e.g., by a pillow), the other asphyxiation prevention valve assembly 3850 may function to prevent the patient from asphyxiating.

[0221] The anti-choking valve assembly 3850 may include an anti-choking valve flap 3851 that covers the anti-choking valve port 3852 in the closed position. The cross-sectional views in Figures 14 and 29 show the anti-choking valve flap 3851 in the closed position. In these figures, it is understood that the anti-choking valve flap 3851 prevents the pressurized airflow entering the conduit connector 3800 from escaping to the surroundings through the anti-choking valve port 3852, and that this pressurized airflow is directed into the patient interface chamber 3001 by the conduit connector outlet port 3804. The anti-choking valve flap 3851 may be configured to remain in the closed position throughout the patient's respiratory cycle (i.e., inhalation and exhalation). Thus, the patient receives the pressurized airflow in their airway to ensure sufficient patency in their airway during inhalation and exhalation. Figures 15 and 30 show the anti-choking valve flap 3851 in the open position. In this open position, the anti-choking valve opening 3852 is not covered, so unless the pressurized airflow is stopped, the patient can breathe from the surroundings through the anti-choking valve opening 3852. Furthermore, the anti-choking valve flap 3851 may be configured such that its open position is a default position, a neutral position, or an undeformed position, so that the anti-choking valve flap 3851 moves to the closed position (by the force of pressure and / or airflow) only when the pressurized airflow is applied to at least the minimum flow rate and / or pressure. Furthermore, the size of the anti-choking valve opening 3852 may be large enough so that if one of the anti-choking valve assemblies 3850 becomes blocked and breathing becomes impossible, the patient can breathe properly through the unblocked anti-choking valve assembly 3850. Furthermore, the size of the anti-choking valve flap 3851 may be large enough to completely block the anti-choking valve opening 3852 in the closed position. Alternatively, the suffocation prevention valve flap 3851 may include holes that allow air to move to the surroundings, for example, for ventilation, when it is in the closed position.

[0222] The choking prevention valve flap 3851 can be joined to the conduit connector housing 3801 by a choking prevention valve flap connector 3854 extending into the choking prevention valve flap connector hole 3853. The choking prevention valve flap 3851 can be permanently attached to the conduit connector housing 3801 in the choking prevention valve flap connector hole 3853 by overmolding it onto the conduit connector housing 3801. The choking prevention valve flap 3851 may be made of a flexible elastic material and can therefore bend from an open position to a closed position due to pressure and / or airflow forces.

[0223] The choking prevention valve assembly 3850 may also include a choking prevention valve hole divider 3855 on the choking prevention valve hole 3852. The choking prevention valve hole divider 3855 can prevent the choking prevention valve flap 3851 from being pushed out of the choking prevention valve hole 3852 (due to pressure within the patient interface chamber 3001).

[0224] 5.3.11 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.

[0225] 5.4 RPT Devices An RPT device 4000 according to one aspect of the present technology comprises mechanical, pneumatic, and / or electrical components and is configured to perform one or more algorithms (e.g., any of the methods described herein, either whole or in part). The RPT device 4000 may be configured to generate an airflow delivered to a patient's airway for the treatment of one or more respiratory conditions described in any of the sections herein.

[0226] In one form, the RPT device 4000 is constructed and arranged to deliver an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O or at least 10 cmH2O or at least 20 cmH2O.

[0227] The RPT device may have an external housing 4010. The external housing 4010 is formed by two parts, an upper part 4012 and a lower part 4014. Further, the external housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0228] The pneumatic path of the pneumatic RPT device 4000 may include one or more air circuit items (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124) as well as one or more transducers 4270 (e.g., a pressure sensor 4272 and a flow sensor 4274).

[0229] One or more of the air path items may be arranged within a removable integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be arranged within the external housing 4010. In one form, the pneumatic block 4020 is supported by the chassis 4016 or formed as part of the chassis 4016.

[0230] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In one alternative configuration, the RPT device 4000 may include more than one PCBA 4202.

[0231] 5.4.1 RPT Devices: Mechanical and Pneumatic Components An RPT device may include one or more of the following components in a single unit. In one alternative configuration, one or more of the following components may be arranged as separate units.

[0232] 5.4.1.1 Air filter (single or multiple) An RPT device according to one embodiment of this technology may include an air filter 4110 or a plurality of air filters 4110.

[0233] In one embodiment, the inlet air filter 4112 is positioned at the beginning of the upstream air pressure path of the pressure generator 4140.

[0234] In one embodiment, the outlet air filter 4114 (e.g., antimicrobial factor) is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0235] 5.4.1.2 Muffler (singular or plural) An RPT device according to one embodiment of this technology may include a muffler 4120 or a plurality of mufflers 4120.

[0236] In one embodiment of this technology, the inlet muffler 4122 is positioned above the pressure generator 4140 within the pneumatic path.

[0237] In one embodiment of this technology, the outlet muffler 4124 is positioned within the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0238] 5.4.1.3 Pressure Generator In one embodiment of this technology, the pressure generator 4140 that generates an airflow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers housed in a blower housing, for example, in a volute. The blower can deliver the air supply at a speed of, for example, up to about 120 liters / minute at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other embodiments up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, which are incorporated herein by reference: U.S. Patent No. 7,866,944, U.S. Patent No. 8,638,014, U.S. Patent No. 8,636,479 and PCT Patent Application Publication WO2013 / 020167.

[0239] The pressure generator 4140 is under the control of the treatment device controller 4240.

[0240] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

[0241] 5.4.1.4 Converters (single or multiple) The converter may be located inside the RPT device or outside the RPT device. The external converter may be located on an air circuit, for example, or may form part of an air circuit (e.g., a patient interface). The external converter may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that transmits or moves the data RPT device).

[0242] In one embodiment of this technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and positioned to generate signals that describe the characteristics of the airflow (e.g., flow rate, pressure, or temperature at that point in the pneumatic path).

[0243] In one embodiment of this technology, one or more transducers 4270 may be located near the patient interface 3000.

[0244] In one embodiment, the signal from the converter 4270 may be filtered (for example, by low-pass, high-pass, or band-pass filtering).

[0245] 5.4.1.4.1 Flow Sensor The flow sensor 4274 according to this technology can be obtained based on a differential pressure transducer (for example, an SDP600 series differential pressure transducer from SENSIRION).

[0246] In one configuration, a signal indicating the flow rate from the flow sensor 4274 is received by the central controller 4230.

[0247] 5.4.1.4.2 Pressure Sensor The pressure sensor 4272 according to this technology can be arranged in communication with both a pneumatic path and a fluid path. One example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. Another suitable pressure sensor is a transducer from the GENERAL ELECTRIC NPA series.

[0248] In one configuration, the signal from the pressure sensor 4272 is received by the central controller 4230.

[0249] 5.4.1.4.3 Motor Speed ​​Converter In one embodiment of this technology, a motor speed transducer 4276 may be used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed transducer 4276 may be provided to the therapeutic device controller 4240. The motor speed transducer 4276 may be, for example, a speed sensor (e.g., a Hall effect sensor).

[0250] 5.4.1.5 Anti-spillback valve In one embodiment of this technology, an anti-spillback valve 4160 may be positioned between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (for example, to the blower motor 4144).

[0251] 5.4.2 RPT Device Electrical Components 5.4.2.1 Power supply The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.

[0252] In one embodiment of this technology, the power supply 4210 supplies power only to the RPT device 4000. In another embodiment of this technology, power is supplied from the power supply 4210 to both the RPT device 4000 and the humidifier 5000.

[0253] 5.4.2.2 Input Devices In one embodiment of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to enable human interaction with the device. The buttons, switches, or dials may be physical or software devices accessible via a touchscreen. The buttons, switches, or dials may, in one embodiment, be physically connected to an external housing 4010, or in another embodiment, be wirelessly connected to a receiver electrically connected to a central controller 4230.

[0254] In one embodiment, the input device 4220 may be constructed and configured to allow a human to select a value and / or a menu option.

[0255] 5.4.2.3 Central Controller In one embodiment of this technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0256] Suitable processors may include x86 Intel processors based on ARM® Cortex®-M processors from ARM Holdings (e.g., S®32 series microcontrollers from ST Microelectronics). In certain alternative forms of this technology, 32-bit RISC CPUs (e.g., STR9 series macrocontrollers from ST Microelectronics) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of macrocontrollers manufactured by Texas Instruments) may also be suitable.

[0257] In one embodiment of this technology, the central controller 4230 is a dedicated electronic circuit.

[0258] In one embodiment, the central controller 4230 is an application-specific integrated circuit. In another embodiment, the central controller 4230 includes discrete electronic components.

[0259] The central controller 4230 may be configured to receive input signals (one or more) from one or more transducers 4270, one or more input devices 4220, and humidifiers 5000.

[0260] The central controller 4230 may be configured to provide output signals (one or more) to one or more of the output devices 4290, the treatment device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0261] In some forms of this technology, the central controller 4230 is configured to embody one or more methods described herein (e.g., one or more algorithms expressed as computer programs recorded in a non-temporary computer-readable recording medium (e.g., memory 4260)). In some forms of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of this technology, some methods may be performed by a remotely located device. For example, a remotely located device may determine ventilator control settings or detect respiratory-related events by analyzing recorded data (e.g., from any of the sensors described herein).

[0262] 5.4.2.4 Clocks The RPT device 4000 may include a clock 4232 connected to the central controller 4230.

[0263] 5.4.2.5 Therapeutic device controllers In one embodiment of this technology, the therapeutic device controller 4240 is a therapeutic control module and forms part of the algorithm executed by the central controller 4230.

[0264] In one embodiment of this technology, the treatment device controller 4240 is a dedicated motor control integrated circuit. For example, in one embodiment, an MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0265] 5.4.2.6 Protection circuit One or more protection circuits 4250 in this technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0266] 5.4.2.7 Memory In one embodiment of this technology, the RPT device 4000 includes a memory 4260 (e.g., non-volatile memory). In some embodiments, the memory 4260 may include battery-powered static RAM. In some embodiments, the memory 4260 may include volatile RAM.

[0267] Memory 4260 may be located on PCBA4202. Memory 4260 may take the form of EEPROM or NAND flash.

[0268] Additionally or alternatively, the RPT device 4000 includes removable memory 4260 (for example, a memory card manufactured in accordance with the Secure Digital (SD) standard).

[0269] In one embodiment of this technology, the memory 4260 functions as a non-temporary computer-readable recording medium. Computer program instructions (e.g., one or more algorithms) representing one or more methods described herein are recorded on this recording medium.

[0270] 5.4.2.8 Data Communication System In one embodiment of this technology, a data communication interface 4280 is provided and connected to a central controller 4230. The data communication interface 4280 may be connectable to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0271] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.

[0272] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 may use wired communication (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE) to connect to the Internet.

[0273] In one embodiment, the local external communication network 4284 uses one or more communication standards (e.g., Bluetooth® or Consumer Infrared Protocol).

[0274] In one embodiment, the remote external device 4286 is one or more computers (e.g., a cluster of networked computers). In another embodiment, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible by a properly authorized person (e.g., a clinician).

[0275] The local external device 4288 may be a personal computer, mobile phone, tablet, or remote control.

[0276] 5.4.2.9 Optional output devices including displays and alarms The output device 4290 according to this technology may take the form of one or more of visual, auditory, and haptic units. The visual display may be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0277] 5.4.2.9.1 Display Driver The display driver 4292 receives characters, symbols, or images to be displayed on the display 4294 as input and converts them into commands to display these characters, symbols, or images on the display 4294.

[0278] 5.4.2.9.2 Display The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an 8-segment display, in which case the display driver 4292 translates each character or symbol (e.g., the digit "0") into eight logical signals indicating whether each of the eight segments should be activated to display a particular character or symbol.

[0279] 5.5 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.

[0280] In detail, the air circuit 4170 may be fluidly connected to the outlet and patient interface of the pneumatic block 4020. 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.

[0281] 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 4230). 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.

[0282] 5.5.1 Oxygen Delivery In one embodiment of this technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (e.g., upstream of the pneumatic block 4020), the air circuit 4170 and / or the patient interface 3000.

[0283] 5.6 Humidifier 5.6.1 Overview of Humidifiers In one embodiment of this technology, a humidifier 5000 is provided for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air (for example, as shown in Figure 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to the ambient air) and temperature of the airflow before it is delivered to the patient's airway.

[0284] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving airflow, and a humidifier outlet 5004 for delivering humidified airflow. In some embodiments, such as those shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.

[0285] 5.6.2 Humidifier Components 5.6.2.1 Water Reservoir In one configuration, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a certain amount of liquid (e.g., water) to be evaporated for humidifying the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum amount of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., an overnight sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).

[0286] In one embodiment, the water reservoir 5110 is configured to humidify the airflow from the RPT device 4000 as the airflow passes through the RPT device 4000. In one embodiment, the water reservoir 5110 may be configured to facilitate the movement of the airflow along a meandering path within the reservoir 5110 while the airflow comes into contact with a certain amount of water in the reservoir 5110.

[0287] In one embodiment, the reservoir 5110 may be removable from the humidifier 5000 in the lateral direction, for example, as shown in Figures 5A and 5B.

[0288] The reservoir 5110 may also be configured to suppress liquid discharge from the reservoir 5110 when the reservoir 5110 is displaced and / or rotated from its normal operating direction (e.g., through any aperture and / or between its subcomponents). Since the airflow to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent leakage and / or loss of air pressure through flow impedance.

[0289] 5.6.2.2 Conductive parts In one configuration, the reservoir 5110 includes a conductive portion 5120 configured to enable efficient heat transfer from the heating element 5240 to a fixed amount of liquid in the reservoir 5110. In one embodiment, the conductive portion 5120 may be arranged as a plate, but other shapes may also be appropriate. The conductive portion 5120, in whole or in part, may be made of a thermally conductive material such as aluminum (e.g., approximately 2 mm thick (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved by a less conductive material in an appropriate geometry.

[0290] 5.6.2.3 Humidifier reservoir dock In one embodiment, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in Figure 5B) configured to receive a humidifier reservoir 5110. In some configurations, the humidifier reservoir dock 5130 may include a locking function (for example, a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130).

[0291] 5.6.2.4 Water Level Indicator The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 5A and 5B. In some forms, the water level indicator 5150 may provide a user, such as a patient or caregiver, with one or more indications of the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 may include notification of the maximum predetermined amount of water, any portion thereof (e.g., 25%, 50%, or 75%, or by volume (e.g., 200 ml, 300 ml, or 400 ml)).

[0292] 5.6.2.5 Humidifier Converter (Single or Multiple) The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 in place of or in addition to the transducer 4270 described above. The humidifier transducer 5210 may include one or more of the following: an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218, as shown in Figure 5C. The humidifier transducer 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., a central controller 4230 and / or a humidifier controller 5250). In some forms, the humidifier transducer may be located outside the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signals to the controller.

[0293] 5.6.2.5.1 Pressure Converter One or more pressure transducers 5212 may be provided in the humidifier 5000 in addition to or instead of the pressure sensors 4272 provided in the RPT device 4000.

[0294] 5.6.2.5.2 Flow Converter In addition to the flow sensor 4274 provided in the RPT device 4000, or in place of the flow sensor 4274 provided in the RPT device, one or more flow converters 5214 may be provided in the humidifier 5000.

[0295] 5.6.2.5.3 Temperature Converter The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures (for example, the temperature of the heating element 5240 and / or the temperature downstream of the airflow at the humidifier outlet 5004). In some embodiments, the humidifier 5000 may further include a temperature sensor 5216 for detecting the temperature of the ambient air.

[0296] 5.6.2.5.4 Humidity Converter In one embodiment, the humidifier 5000 may include one or more humidity sensors 5218 for detecting the humidity of a gas, such as ambient air. In some embodiments, the humidity sensors 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensors may be absolute humidity sensors or relative humidity sensors.

[0297] 5.6.2.6 Heating elements In some cases, the heating element 5240 may be provided in a humidifier 5000 that provides a heat input to one or more of the water volume in the humidifier reservoir 5110 and / or the water volume to the airflow. The heating element 5240 may include a heat-generating component such as an electrical resistance heating track. One suitable embodiment of the heating element 5240 is the layered heating element described, for example, in PCT Patent Application Publication WO2012 / 171072, which is incorporated herein by reference.

[0298] In some configurations, the heating element 5240 may be located within the humidifier base 5006. Within the humidifier base 5006, heat can be transferred to the humidifier reservoir 5110 primarily by conduction, as shown in Figure 5B.

[0299] 5.6.2.7 Humidifier Controller In one configuration of this technology, the humidifier 5000 may include a humidifier controller 5250 as shown in Figure 5C. In one embodiment, the humidifier controller 5250 may be part of a central controller 4230. In another embodiment, the humidifier controller 5250 may be a separate controller capable of communicating with the central controller 4230.

[0300] In one embodiment, the humidifier controller 5250 may receive measurements of characteristics (e.g., temperature, humidity, pressure, and / or flow rate) as input (e.g., measurements of airflow and water in the reservoir 5110 and / or humidifier 5000). The humidifier controller 5250 may also be configured to execute or perform humidifier algorithms and / or deliver one or more output signals.

[0301] As shown in Figure 5C, the humidifier controller 5250 may include one or more controllers (for example, a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4170, and / or a heated element controller 5252 configured to control the temperature of the heated element 5240).

[0302] 5.7 Respiratory waveform Figure 6 shows a model of a typical human respiratory waveform during sleep. The horizontal axis represents time, and the vertical axis represents respiratory flow rate. Since parameter values ​​can vary, typical respiration can have the following approximate values: tidal volume, Vt, 0.5 L; inspiratory time, Ti, 1.6 sec; peak inspiratory flow rate, Q peak, 0.4 L / sec; expiratory time, Te, 2.4 sec; peak expiratory flow rate, Q peak, -0.5 L / sec. The total duration of respiration, Ttot, is approximately 4 seconds. Humans typically breathe about 15 times per minute (BPM), and ventilation, Vent, is approximately 7.5 L / min. In a typical load cycle, the ratio of Ti to Ttot is approximately 40%.

[0303] 5.8 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.

[0304] 5.8.1 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).

[0305] 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.

[0306] For example, the atmosphere surrounding humidifiers humidityThis could be the humidity of the air directly surrounding the humidifier (for example, 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.

[0307] In another embodiment, the ambient pressure may be the pressure directly surrounding or outside the body.

[0308] 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.

[0309] 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.

[0310] 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).

[0311] 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. Sometimes, "flow rate" is simply referred to as "flow."

[0312] 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.

[0313] Humidifier: The term "humidifier" is interpreted to mean 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.

[0314] 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.

[0315] 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.

[0316] 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.

[0317] 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).

[0318] Patient: A person who has or does not have a respiratory illness.

[0319] 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 / cm³ 2 This is equal to approximately 0.98 hectopascals. In this specification, unless otherwise specified, pressure is given in units of cmH2O.

[0320] 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.

[0321] Respiratory pressure therapy (RPT): Addition of air supply to the airway inlet at therapeutic pressure, which is typically positive pressure relative to the atmosphere.

[0322] Ventilator: A mechanical device that provides pressure assistance to help a patient perform some or all of the breathing motion.

[0323] 5.8.1.1 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.

[0324] Polycarbonate is a thermoplastic polymer of bisphenol A carbonate.

[0325] 5.8.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0326] Elastic: Releases virtually all energy upon unloading. Includes, for example, certain silicones and thermoplastic elastomers.

[0327] 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.

[0328] 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.

[0329] 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.

[0330] 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.

[0331] 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.

[0332] 5.8.2 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.

[0333] Respiratory rate: This is the patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0334] Load cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0335] Exercise (breathing): Breathing effort is said to refer to the movements performed by a person's spontaneous breathing.

[0336] The exhalation portion of the respiratory cycle: the period from the start of the exhalation flow to the start of the inhalation flow.

[0337] 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.

[0338] 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: Has a single localized peak, which rises from the beginning and is followed by a relatively flat area. (iv) Inverted chair shape: A relatively flat area is followed by a single localized peak, and this peak occurs in the sloping portion.

[0339] 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.

[0340] Hyperventilation: A condition in which blood flow increases to a level higher than normal.

[0341] 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.

[0342] 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).

[0343] Positive end-expiratory pressure (PEEP): This is the pressure in the lungs that exceeds the amount of air present, and it exists at the end of exhalation.

[0344] Peak flow rate (Qpeak): The maximum flow rate in the inspiratory portion of the respiratory flow waveform.

[0345] 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.

[0346] 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).

[0347] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0348] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0349] (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.

[0350] 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).

[0351] Upper airway obstruction (UAO): Includes both partial and total upper airway obstruction. It may be associated with a flow-limiting condition in which flow may slightly increase or decrease with increasing pressure differences over the upper airway (Stirling register behavior).

[0352] Ventilation: A measurement of the total volume 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.

[0353] 5.8.3 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).

[0354] 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).

[0355] 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.

[0356] 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.

[0357] 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.

[0358] Positive Inspiratory Airway Pressure (IPAP): The maximum desired mask pressure that a ventilator attempts to achieve during the inspiratory portion of breathing.

[0359] 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 base 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).

[0360] 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.

[0361] 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.

[0362] Swing: A term equivalent to pressure assistance.

[0363] 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.

[0364] 5.8.4 Anatomy 5.8.4.1 Anatomical structure of the face Wing (Ala): The "wing" of the outer wall or each nostril (plural: alar)

[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] 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.

[0376] 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.

[0377] Nasolabial fold or groove: A fold or groove of skin that extends from each side of the nose to the corners of the mouth, separating the cheek from the upper lip.

[0378] Nasolabial angle: The angle between the columella and the upper lip, which intersects with the subnasal point.

[0379] Subbase of the ear: The lowest point where the auricle attaches to the skin of the face.

[0380] Ear base point: The highest point where the auricle attaches to the skin of the face.

[0381] 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.

[0382] 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.

[0383] Pogonion: The anterior midpoint of the jaw, located on soft tissue.

[0384] Nasal ridge: The nasal ridge is the midline elevation of the nose, extending from the therion to the nasal tip.

[0385] 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.

[0386] Serion: The most concave point located on soft tissue within the region of the frontonasal suture.

[0387] Septal cartilage (nose): The nasal septum cartilage is part of the septum and divides the anterior part of the nasal cavity.

[0388] 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.

[0389] Subnasal point: Located on soft tissue, this is the point where the columella merges with the upper lip in the midline sagittal direction.

[0390] Supramenton: The most concave point on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue pogonion.

[0391] 5.8.4.2 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.

[0392] Mandible: The mandible forms the lower jaw. The mental protuberance is a bony protuberance in the jaw and forms the jawbone.

[0393] 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.

[0394] 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.

[0395] 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.

[0396] 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.

[0397] Orbit: A bony cavity within the skull that contains the eyeball.

[0398] Parietal bone: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0399] 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.

[0400] Cheekbones: The two cheekbones in the face are located in the upper and outer parts of the face, forming the cheekbones.

[0401] 5.8.4.3 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.

[0402] Larynx: The larynx or vocal organ that houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0403] Lungs: The respiratory organ in humans. The conductive zone of the lungs includes the trachea, bronchi, terminal bronchioles. The respiratory region includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0404] 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 the nasal conchae or nasal bones. The nose is located anterior to the nasal cavity, and posteriorly it connects to the nasopharynx via the posterior nostrils.

[0405] 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).

[0406] 5.8.5 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.

[0407] 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.

[0408] 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.

[0409] 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).

[0410] 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.

[0411] 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.

[0412] 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.

[0413] 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.

[0414] Stiffener: The term "stiffener" is understood to mean a structural component designed to increase the rigidity of another component in at least one direction.

[0415] 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.

[0416] 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.

[0417] Thai (noun): A structure designed to resist tension.

[0418] Ventilation (noun): A structure that allows airflow 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.

[0419] 5.8.6 Structural 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.

[0420] 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.

[0421] 5.8.6.1 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).

[0422] 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.

[0423] 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.

[0424] 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.

[0425] 5.8.6.2 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.

[0426] 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.

[0427] 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).

[0428] 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.

[0429] 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")).

[0430] 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.

[0431] Planar region: A region of a surface where both major curvatures are zero (or zero, for example, within a manufacturing tolerance).

[0432] Surface edge: The boundary or limit of a surface or area.

[0433] 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).

[0434] 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).

[0435] 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".)

[0436] 5.8.6.3 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 be walking 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.

[0437] 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.

[0438] 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.

[0439] 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).

[0440] Contact plane: The plane containing the unit tangent vector and the unit principal normal vector. See Figures 3O and 3P.

[0441] 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.

[0442] 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).

[0443] 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.

[0444] 5.8.6.4 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.

[0445] 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.

[0446] 5.9 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.

[0447] 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.

[0448] 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.

[0449] 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.

[0450] 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.

[0451] All published documents cited herein are used for disclosure and description of methods and / or materials that are the subject of those documents, and are incorporated for reference only. The published documents cited herein are provided solely for the purposes of their disclosure prior to the filing date of this application. Nothing in this specification should be construed as acknowledging or acknowledging 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 herein may differ from the actual dates of the published documents and may require individual verification.

[0452] 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.

[0453] 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.

[0454] 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 process steps in the methods may be described or illustrated in order, such order is not necessary. Those skilled in the art will recognize that such order is changeable and / or that such actions can be performed simultaneously or even synchronously.

[0455] 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.

[0456] [Section 1] It is a patient interface, A plenum chamber that at least partially forms a patient interface chamber pressurized to a therapeutic pressure of at least 6 cmH2O, exceeding the ambient air pressure, wherein the plenum chamber includes a first plenum chamber opening and a second plenum chamber opening, each of which is sized and constructed to receive an airflow at therapeutic pressure for patient respiration, A seal-forming structure constructed and positioned to form a seal over the patient's facial region surrounding the entrance to the patient's airway, wherein the seal-forming structure has at least one hole inside to ensure that airflow at the therapeutic pressure is delivered at least to the entrance to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the patient interface chamber throughout the patient's entire respiratory cycle during use. A first conduit and a second conduit, each sized and constructed to receive the airflow at the therapeutic pressure for the patient's respiration, A first conduit connector configured to pneumatically connect a first conduit to a first plenum chamber opening to provide airflow at the therapeutic pressure to the patient interface chamber for patient respiration, and a second conduit connector configured to pneumatically connect a second conduit to a second plenum chamber opening to provide airflow at the therapeutic pressure to the patient interface chamber for patient respiration, A positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position on the patient's head, wherein the positioning and stabilizing structure includes a positioning and stabilizing structure comprising at least one tie, A patient interface comprising a first conduit connector and a second conduit connector, each including an asphyxiation prevention valve configured to allow the patient to breathe from the atmosphere through their own oral cavity when there is no pressurized airflow through the first plenum chamber opening and the second plenum chamber opening. [Section 2] The patient interface according to paragraph 1, wherein the suffocation prevention valve in each of the first conduit connector and the second conduit connector includes a suffocation prevention valve hole. [Section 3] The patient interface as described in paragraph 2, wherein each of the aforementioned asphyxiation prevention valve holes is shaped and sized to allow the patient to breathe when other asphyxiation prevention valve holes are blocked. [Section 4] The patient interface according to any one of the second to third paragraphs, wherein the suffocation prevention valve in each of the first conduit connector and the second conduit connector further includes a suffocation prevention valve flap. [Section 5] The patient interface according to paragraph 4, wherein the asphyxiation prevention valve flap in each of the first conduit connector and the second conduit connector is configured to block the corresponding asphyxiation prevention valve hole of either the first conduit connector or the second conduit connector when in the closed position, thereby preventing the airflow at the therapeutic pressure moving through either the corresponding first conduit connector or the second conduit connector from leaking into the atmosphere through the asphyxiation prevention valve hole over the patient interface chamber and throughout the patient's entire respiratory cycle. [Section 6] The patient interface according to any one of paragraphs 4 to 5, wherein, in the open position, the asphyxiation prevention valve flaps in each of the first conduit connector and the second conduit connector are configured to allow the patient to breathe through the atmosphere via either of the corresponding asphyxiation prevention valve openings of the first conduit connector and the second conduit connector when there is no pressurized airflow through the first plenum chamber opening and the second plenum chamber opening. [Section 7] The patient interface according to any one of paragraphs 4 to 6, wherein the suffocation prevention valve hole in each of the first conduit connector and the second conduit connector is divided by a suffocation prevention valve hole divider that prevents the corresponding suffocation prevention valve flap from passing through the suffocation prevention valve hole. [Section 8] The patient interface according to any one of the four to seventh paragraphs, wherein each of the aforementioned suffocation prevention valve flaps further includes at least one vent that allows a portion of the airflow at the therapeutic pressure to leak into the atmosphere. [Section 9] The suffocation prevention valve in each of the first conduit connector and the second conduit connector further includes a suffocation prevention valve flap connector hole, The patient interface according to any one of claims 4 to 8, wherein the suffocation prevention valve flap in each of the first conduit connector and the second conduit connector further includes a suffocation prevention valve flap connector that connects the suffocation prevention valve flap to the suffocation prevention valve flap connector hole of the corresponding suffocation prevention valve in either the first conduit connector or the second conduit connector. [Section 10] The patient interface according to any one of paragraphs 1 to 9, wherein the suffocation prevention valves in the first conduit connector and the second conduit connector are configured to operate independently of each other. [Section 11] The patient interface according to any one of the first to tenth paragraphs, wherein each of the first conduit connector and the second conduit connector further includes at least one conduit connector vent configured to allow a continuous flow of exhaled gas by the patient from inside the patient interface chamber to the atmosphere, the at least one conduit connector vent being sized and shaped to maintain therapeutic pressure within the patient interface chamber during use. [Section 12] The patient interface according to paragraph 11, wherein each of the first conduit connector and the second conduit connector further includes a conduit connector vent inlet configured to direct a continuous flow of exhaled gas by the patient from inside the patient interface chamber to the at least one conduit connector vent. [Section 13] The patient interface according to any one of the claims 11 to 12, wherein each of the first conduit connector and the second conduit connector further includes a conduit connector vent outlet configured to direct a continuous flow of exhaled gas by the patient from at least one conduit connector vent to the atmosphere. [Section 14] The patient interface according to any one of claims 11 to 13, wherein each of the first conduit connector and the second conduit connector further includes a partition that prevents the airflow at the therapeutic pressure passing through each of the first conduit connector and the second conduit connector from passing directly into the atmosphere through the at least one conduit connector vent. [Section 15] The patient interface according to any one of the paragraphs 11 to 14, wherein each of the first conduit connector and the second conduit connector further comprises a diffuser cavity containing diffuser material. [Section 16] The patient interface according to paragraph 15, wherein the diffuser cavity and the diffuser material are positioned downstream of a conduit connector vent relative to a continuous gas flow in order to diffuse the continuous gas flow before it leaks into the atmosphere. [Section 17] The patient interface according to any one of paragraphs 15 to 16, wherein each of the first conduit connector and the second conduit connector further includes a diffuser cover for enclosing diffuser material in a diffuser cavity. [Section 18] The patient interface according to paragraph 17, wherein the diffuser cover is removable to allow removal and replacement of the diffuser material. [Section 19] The patient interface according to any one of claims 15 to 18, wherein each of the first conduit connector and the second conduit connector further includes a conduit connector vent outlet, the conduit connector vent outlet being positioned such that at least a portion of a continuous gas flow passes through the diffuser material before leaking into the atmosphere through the conduit connector vent outlet. [Section 20] The patient interface according to any one of paragraphs 11 to 19, wherein each of the first conduit connector and the second conduit connector further includes a conduit connector spacer that maintains a gap between each of the first conduit connector and the second conduit connector and a portion of the plenum chamber, thereby allowing a continuous gas flow to leak from each of the first conduit connector and the second conduit connector into the atmosphere. [Section 21] The plenum chamber comprises at least one plenum chamber vent, as described in any one of the first to tenth paragraphs. [Section 22] The plenum chamber comprises a plurality of plenum chamber vents, as described in paragraph 21, for the patient interface. [Section 23] The patient interface according to any one of paragraphs 1 to 22, wherein each of the first conduit connector and the second conduit connector further includes a conduit connection end configured to connect to either the first conduit or the second conduit. [Section 24] The patient interface according to any one of claims 1 to 23, wherein each of the first conduit connector and the second conduit connector further includes a conduit connector end defining a conduit connector inlet hole configured to receive airflow at the therapeutic pressure from the corresponding first conduit and the second conduit. [Section 25] The patient interface according to paragraph 24, wherein each of the first conduit connector and the second conduit connector further includes a conduit connector outlet defining a conduit connector outlet hole configured to direct airflow at the therapeutic pressure into the patient interface chamber. [Section 26] The patient interface described in paragraph 25, wherein each conduit connector end is oriented substantially perpendicular to the corresponding conduit connector outlet. [Section 27] The plenum chamber further includes a connecting rim in either the first plenum chamber opening or the second plenum chamber opening, The patient interface according to any one of claims 1 to 26, wherein the first conduit connector and the second conduit connector further include at least one conduit connector mounting structure configured to connect to the connecting rim in either the first plenum chamber opening or the second plenum chamber opening. [Section 28] The patient interface according to any one of paragraphs 1 to 27, wherein each of the first conduit connector and the second conduit connector is removable from the plenum chamber. [Section 29] Each of the first conduit connector and the second conduit connector is permanently connected to the plenum chamber, as described in any one of paragraphs 1 to 28. [Section 30] The patient interface according to any one of paragraphs 1 to 29, wherein each of the first conduit connector and the second conduit connector is configured to remain stationary when connected to the plenum chamber. [Section 31] A patient interface according to any one of claims 1 to 30, further comprising a seal between each of the first conduit connector and the second conduit connector and the corresponding of the first plenum chamber opening and the second plenum chamber opening. [Section 32] The patient interface according to paragraph 31, wherein the seal may be formed in each of the first conduit connector and the second conduit connector, and the seal is configured to engage the plenum chamber in either the corresponding first plenum chamber opening or the second plenum chamber opening. [Section 33] The patient interface according to paragraph 32, wherein the seal is permanently joined to either the first conduit connector or the second conduit connector. [Section 34] The seal is made of silicone, and is a patient interface as described in any one of paragraphs 31 to 33. [Section 35] The positioning and stabilizing structure further includes a pair of upper ties, each of which is constructed and positioned such that, in use, at least a portion of the upper tie rests on a region of the patient's head above the upper point of the base of the ears. The patient interface according to any one of claims 1 to 34, wherein the positioning and stabilizing structure further comprises a pair of downward ties, each of which is constructed and positioned such that, in use, at least a portion of the downward tie rests in a region of the patient's head below the subauricular base of the patient's head. [Section 36] The patient interface according to paragraph 35, wherein each of the first conduit connector and the second conduit connector further comprises a downward tie connector configured to connect to one of the corresponding downward ties. [Section 37] The patient interface according to paragraph 36, further comprising clips for detachably connecting each of the downward ties to one of the corresponding downward tie connectors. [Section 38] The clip further includes a magnet, as described in paragraph 37. [Section 39] Further includes a pair of downward tie tabs, each configured to connect to one of the corresponding downward ties, The patient interface according to paragraph 35, wherein each of the first conduit connector and the second conduit connector further includes a flange configured to connect to either of the corresponding lower tie tabs. [Section 40] Each of the flanges further includes a flange opening and a recess, The patient interface according to paragraph 39, wherein each of the lower tie tabs further includes a tab connector configured to join each of the lower tie tabs to one of the corresponding flanges by passing through the corresponding flange opening and engaging with the corresponding recess. [Section 41] The system further includes clips configured to connect to each of the aforementioned lower ties, The patient interface according to paragraph 39 or 40, wherein each of the lower tie tabs further comprises a clip receiver configured to be detachably connected to one of the corresponding clips to which the lower tie is connected. [Section 42] The patient interface according to paragraph 41, wherein each of the clips and each of the clip receivers includes a magnet that is oriented and charged to facilitate a removable connection. [Section 43] The patient interface according to any one of paragraphs 41 to 42, wherein each of the clip receivers includes a notch, and each of the clips includes a projection, each projection configured to engage with a corresponding notch to restrict the rotation of the clip relative to the corresponding clip receiver. [Section 44] The patient interface according to any one of claims 1 to 43, wherein each of the first conduit connector and the second conduit connector further includes a first tab and a second tab that releasably connect the first conduit connector and the second conduit connector to the plenum chamber in a first plenum chamber opening and a second plenum chamber opening, respectively. [Section 45] The patient interface according to paragraph 44, wherein the first tab and the second tab are configured such that the first conduit connector and the second conduit connector can only be connected to the plenum chamber by engaging the first tab with the plenum chamber and then engaging the second tab with the plenum chamber. [Section 46] The patient interface according to paragraph 45, wherein the first tab and the second tab are configured such that the first conduit connector and the second conduit connector can only be disconnected from the plenum chamber by disengaging the second tab from the plenum chamber and then disengaging the first tab from the plenum chamber. [Section 47] The plenum chamber further includes slots proximal to the first plenum chamber opening and the second plenum chamber opening, The first tab of each of the first conduit connector and the second conduit connector is configured to engage with the slot which is coupled to either the first plenum chamber hole or the second plenum chamber hole, The patient interface according to paragraph 45 or 46, wherein each of the first conduit connector and the second conduit connector is rotatable about the corresponding slot when the first tab of each of the first conduit connector and the second conduit connector is engaged with the corresponding slot. [Section 48] The plenum chamber further includes return stoppers proximal to the first plenum chamber opening and the second plenum chamber opening, The patient interface according to paragraph 47, wherein the second tab of each of the first conduit connector and the second conduit connector further includes a catch, the catch being configured to snap-fit ​​with the retainer which is engaged with either the first plenum chamber opening or the second plenum chamber opening. [Section 49] The patient interface described in paragraph 48, wherein the second tab of each of the first conduit connector and the second conduit connector is flexible. [Section 50] The patient interface according to either of paragraphs 48 or 49, wherein each of the first conduit connector and the second conduit connector further includes gaps on both sides of the corresponding second tab, thereby allowing the second tab to be cantilevered from each of the first conduit connector and the second conduit connector. [Section 51] The patient interface according to any one of claims 1 to 50, wherein the seal-forming structure further comprises a nasal portion configured to seal around the patient's nostrils and a mouth portion configured to seal around the patient's mouth. [Section 52] The seal-forming structure further includes a nasal opening configured to provide pneumatic communication between the patient's nostrils and the patient interface chamber. The patient interface according to any one of claims 1 to 51, wherein the seal-forming structure further includes a mouth portion opening configured to provide pneumatic communication between the patient's mouth and the patient interface chamber. [Section 53] Each of the first conduit and the second conduit is in pneumatic communication with the connection port housing, A patient interface according to any one of claims 1 to 52, further comprising a connection port connected to the connection port housing, wherein the connection port is configured to be connected to an air circuit to receive an airflow at the therapeutic pressure. [Section 54] The aforementioned connection port further includes an elbow, as described in paragraph 53, for the patient interface. [Section 55] The patient interface according to any one of the paragraphs 53 to 54, wherein the connection port further includes at least one ventilation hole. [Section 56] The patient interface according to any one of paragraphs 53 to 55, wherein the connection port is rotatably connected to the connection port housing. [Section 57] The patient interface according to any one of paragraphs 53 to 56, wherein the connection port and the connection port housing are configured to be positioned above the patient's head when in use. [Section 58] A respiratory therapy system, A patient interface as described in any one of paragraphs 1 to 57, A respiratory pressure therapy device configured to generate airflow at the aforementioned therapeutic pressure, A respiratory therapy system including an air circuit configured to direct the airflow at the therapeutic pressure from the respiratory pressure therapy device to the patient interface. [Explanation of Symbols]

[0457] 5.10 List of reference codes 1000 patients 1100 Bedmate 3000 Patient Interfaces 3001 Patient Interface Chamber 3002 Subassembly 3100 Seal-forming structure 3101 Nose part 3102 Mouth part 3103 Nasal hole 3104 Oral foramen 3105 Nasal aperture divider 3200 Plenum Chamber 3201 Plenum Chamber Hole 3202 Connection Rim 3203 slots 3204 Reversal stop 3210 Tendon 3220 Top 3230 Lower point 3300 Positioning and stabilization structure 3301 clip 3302 Upper Thailand 3303 Downward tie 3304 Posterior part 3305 Clip Magnet 3306 Crossbar 3307 Overhang 3400 Ventilation section 3401 Plenum Chamber Vent 3600 connection ports 3700 Forehead support 3800 Conduit Connector 3801 Conduit Connector Housing 3802 Conduit connector end 3803 Conduit connector inlet hole 3804 Conduit connector outlet hole 3805 Baffle 3806 Conduit Connector Spacer 3807 Conduit connector mounting structure 3808 Conduit connector outlet 3830 Conduit connector vent outlet 3831 Conduit connector vent hole 3832 Conduit connector vent inlet 3833 Conduit connector ventilation spacer 3850 Choking prevention valve assembly 3851 Anti-choking valve flap 3852 Anti-choking valve hole 3853 Anti-choking valve flap connector hole 3854 Anti-choking valve flap connector 3855 Anti-choking valve hole divider 3856 Choking prevention valve flap hinge 3860 Intermediate conduit connector inlet seal 3861 Conduit connector outlet seal 3870 Diffuser Cover 3871 Diffuser Cavity 3880 Downward Tie Tab 3881 Clip Receiver 3882 Notch 3883 Flexible part 3884 Tab Connector 3885 Flange 3886 recess 3887 Flange opening 3890 First tab 3891 Second tab 3892 Catch 3893 Gap 3900 Conduit 3901 Sleeves 3902 Thai Connector 3903 Connection Port Housing 3904 Bellows section 4000 RPT devices 4010 External Housing 4012 Internal part 4014 Lower 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic Block 4110 Air Filter 4112 Inlet air filter 4114 Outlet air filter 4120 Muffler 4122 Entrance muffler 4124 Exhaust muffler 4140 Pressure Generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air Circuit 4180 Supplemental oxygen 4200 Electrical components 4202 Printed Circuit Board Assembly (PBCA) 4210 Power supply 4220 Input Devices 4230 Central Controller 4232 Clock 4240 Therapeutic Device Controller 4250 protection circuit 4260 memory 4270 Converter 4272 Pressure Sensor 4274 Flow Sensor 4276 Motor Speed ​​Converter 4280 Data communication interface 4282 Remote External Communication Network 4284 Local external communication network 4286 Remote External Devices 4288 Local external device 4290 Output Device 4292 Display Driver 4294 displays 5000 humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier Base 5110 Humidifier Reservoir 5110 Reservoir 5120 Conductive parts 5130 Humidifier Reservoir Dock 5135 Locking Lever 5150 Water Level Indicator 5210 Humidifier Converter 5212 Air pressure sensor 5214 Flow Converter 5216 Temperature Sensor 5218 Humidity Sensor 5240 heating element 5250 Humidifier Controller 5251 Central Humidifier Controller 5252 Heating element controller 5254 Air Circuit Controller 7700 Elbow Assembly 7710 Elbow component 7720 Ventilation holes 7730 Clip component 7740 Pinch Arm 7750 Catch area 7760 Connection part 7780 Button or trigger area 7781 Finger grip part 7790 Swivel Connector 7900 Ring component

Claims

1. A conduit assembly for a patient interface that provides a flow of air at a therapeutic pressure exceeding ambient air pressure to the patient's airway, A first conduit and a second conduit, each sized and constructed to receive an airflow at the therapeutic pressure for the patient to breathe, made of silicone, and each of the first and second conduits is configured to pass along the corresponding side of the patient's head between the corresponding eyes and ears of the patient, A first conduit connector configured to pneumatically connect the first conduit to a first plenum chamber opening of the patient interface to provide airflow at the therapeutic pressure to the patient interface chamber for the patient to breathe, and a second conduit connector configured to pneumatically connect the second conduit to a second plenum chamber opening of the patient interface to provide airflow at the therapeutic pressure to the patient interface chamber for the patient to breathe, each of which is constructed of a first rigid plastic material, In a conduit assembly comprising, The first conduit connector and the second conduit connector each include an asphyxiation prevention valve configured to allow the patient to breathe from the atmosphere when there is no pressurized airflow through the first plenum chamber opening and the second plenum chamber opening, The first conduit connector and the second conduit connector each further include a conduit connection end connected to the corresponding conduit among the first and second conduits, A conduit assembly comprising a first conduit connector and a second conduit connector, each further comprising a seal configured to seal the plenum chamber of the patient interface, with the first plenum chamber opening and the second plenum chamber opening corresponding to each other.

2. The conduit assembly according to claim 1, wherein the seal is permanently coupled to the corresponding one of the first conduit connector and the second conduit connector.

3. The conduit assembly according to claim 1 or 2, wherein the seal is made of silicone.

4. The conduit assembly according to any one of claims 1 to 3, wherein the suffocation prevention valves of the first conduit connector and the second conduit connector each include a suffocation prevention valve hole.

5. The conduit assembly according to claim 4, wherein each anti-choking valve opening is shaped and sized to allow a patient to breathe through it if another anti-choking valve opening is blocked.

6. The conduit assembly according to claim 4 or 5, wherein each of the first conduit connector and the second conduit connector is further provided with a choking prevention valve flap.

7. The conduit assembly according to claim 6, wherein the suffocation prevention valve flap in each of the first conduit connector and the second conduit connector is configured to block the corresponding suffocation prevention valve opening of either the first conduit connector or the second conduit connector when in the closed position, thereby preventing the airflow at the therapeutic pressure moving through either the corresponding first conduit connector or the second conduit connector from leaking into the atmosphere through the suffocation prevention valve opening over the patient interface chamber and throughout the patient's entire respiratory cycle.

8. The conduit assembly according to claim 6 or 7, wherein, in the open position, the asphyxiation prevention valve flaps in each of the first conduit connector and the second conduit connector are configured to allow the patient to breathe from the atmosphere through either of the corresponding asphyxiation prevention valve openings of the first conduit connector and the second conduit connector when there is no pressurized airflow through the first plenum chamber opening and the second plenum chamber opening.

9. The conduit assembly according to any one of claims 6 to 8, wherein the choking prevention valve hole in each of the first conduit connector and the second conduit connector is divided by a choking prevention valve hole divider that prevents the corresponding choking prevention valve flap from passing through the choking prevention valve hole.

10. The conduit assembly according to any one of claims 6 to 9, wherein each of the suffocation prevention valve flaps further comprises at least one vent that allows a portion of the airflow at the treatment pressure to leak into the atmosphere.

11. The suffocation prevention valve in each of the first conduit connector and the second conduit connector further includes a suffocation prevention valve flap connector hole, The conduit assembly according to any one of claims 6 to 10, wherein the choking prevention valve flap in each of the first conduit connector and the second conduit connector further includes a choking prevention valve flap connector that connects the choking prevention valve flap to the choking prevention valve flap connector hole of the corresponding choking prevention valve in either the first conduit connector or the second conduit connector.

12. The conduit assembly according to any one of claims 1 to 11, wherein the suffocation prevention valves in the first conduit connector and the second conduit connector are configured to operate independently of each other.

13. The conduit assembly according to any one of claims 1 to 12, wherein each of the conduit connection ends forms a conduit connector inlet hole configured to receive airflow at the therapeutic pressure from the corresponding first conduit and the second conduit.

14. The conduit assembly according to claim 13, wherein each of the first conduit connector and the second conduit connector further includes a conduit connector outlet defining a conduit connector outlet hole configured to direct airflow at the therapeutic pressure into the patient interface chamber.

15. The conduit assembly according to claim 14, wherein each conduit connector end is oriented substantially perpendicular to the corresponding conduit connector outlet.

16. The conduit assembly according to any one of claims 1 to 15, wherein each of the first conduit connector and the second conduit connector is configured to be removable from the plenum chamber.

17. The conduit assembly according to any one of claims 1 to 16, wherein each of the first conduit connector and the second conduit connector is configured to remain stationary when connected to the plenum chamber.

18. Each of the first conduit and the second conduit is in pneumatic communication with the connection port housing, The conduit assembly according to any one of claims 1 to 17, further comprising a connection port connected to the connection port housing, wherein the connection port is configured to be connected to an air circuit to receive airflow at the therapeutic pressure.

19. The conduit assembly according to claim 18, wherein the connection port further includes an elbow.

20. The conduit assembly according to claim 18 or 19, wherein the connection port further includes at least one ventilation hole.

21. The conduit assembly according to any one of claims 18 to 20, wherein the connection port is rotatably connected to the connection port housing.

22. The conduit assembly according to any one of claims 18 to 21, wherein the connection port and the connection port housing are configured to be positioned above the patient's head when in use.

23. A conduit assembly according to any one of claims 1 to 22, further comprising a positioning and stabilizing structure that provides force to hold the patient interface in a therapeutically effective position on the patient's head, the positioning and stabilizing structure further comprising at least one tie.

24. The conduit assembly according to any one of claims 1 to 23, wherein each of the first conduit and the second conduit is provided with a tie connector configured to connect to a corresponding tie of a positioning and stabilizing structure.

25. At least 6 cmH higher than the ambient air pressure ２ A plenum chamber that at least partially forms a patient interface chamber pressurized to a therapeutic pressure greater than 0, the plenum chamber being constructed of a second rigid plastic material, comprising a first plenum chamber opening and a second plenum chamber opening, the first plenum chamber opening and the second plenum chamber opening each being sized and constructed to receive an airflow at therapeutic pressure for the patient to breathe, A seal-forming structure constructed and positioned to form a seal over the patient's facial region surrounding the entrance to the patient's airway, constructed of a soft, flexible elastic material and coupled to the plenum chamber, having at least one hole internally to ensure that the airflow at the therapeutic pressure is delivered at least to the patient's nostrils, and the seal-forming structure is constructed and positioned to maintain the therapeutic pressure within the patient interface chamber throughout the patient's entire respiratory cycle during use, The conduit assembly according to claim 24, In a patient interface comprising, A patient interface in which each of the first rigid plastic material and the second rigid plastic material is rigider than the soft, flexible elastic material.

26. The patient interface according to claim 25, wherein the plenum chamber includes a plurality of plenum chamber vents.

27. The plenum chamber further includes a connecting rim in either the first plenum chamber opening or the second plenum chamber opening, The patient interface according to claim 25 or 26, wherein the first conduit connector and the second conduit connector further include at least one conduit connector mounting structure configured to connect to the connecting rim in either the first plenum chamber opening or the second plenum chamber opening.

28. The positioning and stabilizing structure further includes a pair of upper ties, each of which is constructed and positioned such that, in use, at least a portion of the upper tie rests on a region of the patient's head above the upper point of the base of the ears. The patient interface according to any one of claims 25 to 27, wherein the positioning and stabilizing structure further comprises a pair of downward ties, each of which is constructed and positioned such that, in use, at least a portion of the downward tie rests in a region of the patient's head below the subauricular base of the patient's head.

29. The patient interface according to claim 28, wherein each of the first conduit connector and the second conduit connector further comprises a downward tie connector configured to connect to one of the corresponding downward ties.

30. The patient interface according to claim 29, further comprising a clip for detachably connecting each of the lower ties to a corresponding lower tie connector.

31. The patient interface according to claim 30, wherein the clip further includes a magnet.

32. Further includes a pair of downward tie tabs, each configured to connect to one of the corresponding downward ties, The patient interface according to claim 28, wherein each of the first conduit connector and the second conduit connector further includes a flange configured to connect to either of the corresponding lower tie tabs.

33. Each of the flanges further includes a flange opening and a recess, The patient interface according to claim 32, wherein each of the lower tie tabs further comprises a tab connector configured to join each of the lower tie tabs to one of the corresponding flanges by passing through the corresponding flange opening and engaging with the corresponding recess.

34. The system further includes clips configured to connect to each of the aforementioned lower ties, The patient interface according to claim 32 or 33, wherein each of the lower tie tabs further comprises a clip receiver configured to be detachably connected to one of the corresponding clips to which the lower tie is connected.

35. The patient interface according to claim 34, wherein each of the clips and each of the clip receivers includes a magnet that is oriented and charged to facilitate a removable connection.

36. The patient interface according to claim 34 or 35, wherein each of the clip receivers includes a notch, and each of the clips includes a projection, the projection of which is configured to engage with a corresponding notch to restrict the rotation of the clip relative to the corresponding clip receiver.

37. The patient interface according to any one of claims 25 to 36, wherein the seal-forming structure further comprises a nasal portion configured to seal around the patient's nostrils and a mouth portion configured to seal around the patient's mouth.

38. The seal-forming structure further includes a nasal opening configured to provide pneumatic communication between the patient's nostrils and the patient interface chamber. The patient interface according to any one of claims 25 to 37, wherein the seal-forming structure further includes a mouth portion opening configured to provide pneumatic communication between the patient's mouth and the patient interface chamber.

39. A respiratory therapy system, A patient interface according to any one of claims 25 to 38, A respiratory pressure therapy device configured to generate airflow at the aforementioned therapeutic pressure, A respiratory therapy system including an air circuit configured to direct the airflow at the therapeutic pressure from the respiratory pressure therapy device to the patient interface.

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