Catheter headgear connector for patient interface

Abstract

A patient interface can include a plenum chamber at least partially defining a patient interface chamber, a seal-forming structure constructed and arranged to form a seal with a region of a 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 stabilising structure to provide a force that holds the seal-forming structure on the patient’s head, the positioning and stabilising structure comprising at least one tie, wherein the at least one conduit connector comprises an anti-asphyxia valve configured to allow the patient to breathe from ambient through their mouth in the absence of the flow of pressurised air.

Description

[0001] This application is a divisional application of patent application number 201880082889.9, filed on December 21, 2018, entitled "Catheter Headband Connector for Patient Interface". Patent application 201880082889.9 is an application that entered the Chinese national phase of PCT international application PCT / AU2018 / 051382.

[0002] This patent document disclosure contains copyrighted material. The copyright holder does not object to the reproduction of this patent document or patent disclosure by any person in the form it appears in the patent office documents or records, but otherwise reserves all copyright rights.

[0003] 1. Cross-references to related applications

[0004] This application claims the benefit of U.S. Provisional Application No. 62 / 609,909, filed December 22, 2017, the entire contents of which are incorporated herein by reference. Background Technology 2.1 Technical Field

[0006] This technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment, and their uses.

[0007] 2.2 Description of relevant technologies

[0008] 2.2.1 The human respiratory system and its disorders

[0009] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0010] The airways consist of a series of branching tracheae, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from inhaled air and expelling carbon dioxide in the opposite direction. The trachea divides into the right main bronchus and the left main bronchus, which eventually further divide into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, by John B. West, Lippincott Williams & Wilkins, published in 2012.

[0011] A range of breathing disorders exist. Some disorders can be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0012] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0013] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. This condition causes the affected patient to stop breathing, typically in cycles lasting 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can contribute to cardiovascular disease and brain damage. This complication is a common disorder, particularly among middle-aged overweight men, although affected individuals may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0014] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Due to the repetitive hypoxia, CSR can be harmful. In some patients, CSR is associated with repetitive microarousing from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0015] Respiratory failure is a broad term encompassing respiratory disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following disorders.

[0016] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0017] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0018] Chronic obstructive pulmonary disease (COPD) includes any of a group of lower airway diseases that share certain common characteristics. These diseases include increased airflow resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0019] Neuromuscular disease (NMD) is a broad term encompassing many diseases and disorders that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle muscular dystrophy, facial-shoulder-arm muscular dystrophy, and myotonic dystrophy). Symptoms of respiratory failure in NMD include: progressive general weakness, difficulty swallowing, shortness of breath during exercise and at rest, fatigue, drowsiness, morning headache, difficulty concentrating, and mood changes.

[0020] Chest wall disorders are a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause 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.

[0021] A range of treatments have been used to treat or alleviate these conditions. Furthermore, these treatments can be used by other healthy individuals to prevent respiratory distress. However, these treatments have many drawbacks.

[0022] 2.2.2 Treatment

[0023] Various treatments have been used to treat one or more of the above-mentioned respiratory disorders, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), and invasive ventilation (IV).

[0024] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA with CPAP can be voluntary, therefore patients may choose not to adhere to treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or unsightly, among other things.

[0025] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) as well as forms of respiratory failure such as orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-invasive respiratory disease (NMD), and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0026] Invasive ventilation (IV) provides ventilatory support to patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0027] 2.2.3 Treatment System

[0028] These treatments can be provided by treatment systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor conditions without treatment.

[0029] The treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0030] Another type of treatment system is the mandibular repositioning device.

[0031] 2.2.3.1 Patient Interface

[0032] A patient interface can be used to attach a breathing device to its wearer, for example, by providing an airflow into the airway. The airflow can be provided to the patient's nose and / or mouth via a mask, to the patient's mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of about 10 cmH2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of about 10 cmH2O to the airway.

[0033] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems for underwater swimming or diving may be configured to prevent water from flowing in from external high pressure, rather than maintaining air at a pressure higher than ambient temperature internally.

[0034] Some masks may be clinically disadvantageous for this technology, such as those that block airflow through the nose and only allow it through the mouth.

[0035] If some masks require patients to insert a portion of the mask structure into their mouths to form and maintain a seal through their lips, they may be uncomfortable or not feasible for this technology.

[0036] Some face masks may not be suitable for use while sleeping (e.g., when sleeping on your side in bed with your head resting on a pillow).

[0037] The design of the patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly from person to person. Because the head comprises bones, cartilage, and soft tissues, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during the duration of respiratory therapy.

[0038] Because of these challenges, some face shields suffer from one or more of the following problems: obtrusive, unattractive, expensive, mismatched, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized face shield can lead to decreased adherence, reduced comfort, and worse patient outcomes. Face shields designed solely for pilots, designed as part of personal protective equipment (e.g., filtering face shields), SCUBA face shields, or face shields designed for administering anesthetics may be acceptable for their original application, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment. This is especially true if the face shield is worn during sleep.

[0039] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing difficulties. However, patient adherence may occur if the mask is uncomfortable or difficult to use. Since patients are generally advised to wash their masks regularly, they may not wash their masks if they are difficult to clean (e.g., difficult to assemble or disassemble), which could affect adherence.

[0040] While masks designed for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea can be used for other applications.

[0041] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0042] 2.2.3.1.1 Sealing Formation Structure

[0043] Patient interfaces may include seal-forming structures. Because they come into direct contact with the patient's face, the shape and construction of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0044] The patient interface can be partially characterized based on the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils during use. Such a single element may be designed, for example, to cover the upper lip and bridge of the nose region of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0045] A sealing structure that works effectively in one area of ​​a patient's face may not be suitable for another, for example, because the shape, structure, variability, and sensitivity of different areas of the patient's face vary. For instance, a seal that covers a patient's forehead on swimming goggles may not be suitable for use on a patient's nose.

[0046] Certain sealing structures can be designed for mass production, making a design suitable, comfortable, and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the shape of the patient's face and the sealing structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0047] One type of seal-forming structure extends around the periphery of a patient interface and, when force is applied to the patient interface while the seal-forming structure engages face-to-face with the patient's face, it seals the patient's face. The seal-forming structure may include an air or fluid-filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0048] Another type of seal-forming structure includes a sheet-like seal of thin material positioned around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous type of seal-forming section, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or bend during use, leading to leakage.

[0049] Another type of seal-forming structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0050] Another form of sealing can be achieved using adhesives. Some patients may find it inconvenient to constantly apply and remove adhesives from their face.

[0051] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0052] One form of nasal pillow was found in Adam Circuit, manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0053] ResMed Limited has manufactured the following products, including nose pillows: SWIFT TM Nose pillow mask, SWIFT TM Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and MIRAGE LIBERTY TM Full-face mask. The following patent application assigned to ResMed Ltd. describes an example of a nose pillow mask: International Patent Application WO2004 / 073778 (which describes a ResMed Ltd. SWIFT mask). TM Other aspects of the nose pillow); U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc.'s SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO 2005 / 063328 and WO 2006 / 130903 (which describe ResMed Ltd. MIRAGE LIBERTY) TM Other aspects of the full-face mask); International Patent Application WO 2009 / 052560 (which describes ResMed Ltd.'s SWIFT) TM Other aspects of the FX nose pillow).

[0054] 2.2.3.1.2 Positioning and Stability

[0055] The sealing structure of the patient interface used in positive pressure therapy is subject to a force corresponding to the air pressure that would disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain it in a sealed relationship with the appropriate part of the face.

[0056] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, using adhesives may be uncomfortable for some people.

[0057] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following problems: ill-fitting, bulky, uncomfortable, and difficult to use.

[0058] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device -

[0059] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to achieve one or more of the aforementioned treatments, for example, by operating the device to generate an airflow to an interface leading to the airway. The airflow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0060] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, medical air pressure generators have specific requirements that are not met by more general air pressure generators, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0061] One example of a specific requirement for certain RPT devices is noise.

[0062] Noise output level table for existing RPT devices (only one sample, measured in CPAP mode using the test method specified in ISO 3744 at 10 cmH2O).

[0063] RPT device name A-weighted sound pressure level dB(A) Year (approximately) <![CDATA[C series Tango TM > 31.9 2007 <![CDATA[C-Series Tango with Humidifier TM > 33.1 2007 <![CDATA[S8 Escape TM II]]> 30.5 2005 <![CDATA[With H4i TM S8 Escape humidifier TM II]]> 31.1 2005 <![CDATA[S9 AutoSet TM ]]> 26.5 2010 <![CDATA[S9 AutoSet with H5i humidifier TM > 28.6 2010

[0064] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators (such as the ResMed Stellar) TM The range of adult and pediatric ventilators can provide invasive and non-invasive non-dependent ventilation support for a range of patients to treat a variety of conditions, including but not limited to NMD, OHS and COPD.

[0065] EliséeTM 150 ventilator and ResMed VS III TM Ventilators provide support for invasive and non-invasive ventilation suitable for adult or pediatric patients to treat a variety of conditions. These ventilators offer volumetric and pressure-based ventilation modes with single- or dual-branch circuits. RPT (Respiratory Pressure Test) devices typically include a pressure generator, such as an electrically driven blower or compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, airflow can be supplied to the patient's airway under positive pressure. The RPT device outlet is connected via an air circuit to a patient interface, such as those described above.

[0066] Device designers may face an infinite number of choices. Design standards often conflict, meaning that some design choices are unconventional or unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to small and subtle changes in one or more parameters.

[0067] 2.2.3.3 Humidifier

[0068] Delivering an unhumidified airflow can lead to airway dryness. Using a humidifier with an RPT device and patient interface produces humidified gas, minimizing dryness of the nasal mucosa and increasing patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air.

[0069] A number of artificial humidification devices and systems are known, but they may not meet the specific requirements of medical humidifiers.

[0070] When needed, typically in areas where patients may sleep or rest (e.g., in hospitals), medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to ambient air. Medical humidifiers intended for bedside placement can be very small. Medical humidifiers can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed by the patient; however, these systems also humidify and / or heat the entire room, which can cause discomfort to the occupant. Furthermore, medical humidifiers may have stricter safety restrictions than industrial humidifiers.

[0071] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide insufficient humidification, and some may be difficult or inconvenient for patients to use.

[0072] 2.2.3.4 Data Management

[0073] Data may be obtained for clinical reasons to determine whether a patient prescribed respiratory therapy is "compliant," such as if the patient used their RPT device according to one or more "compliance rules." One example of a CPAP compliance rule is that, to be considered compliant, a patient needs to use their RPT device for at least four hours each night for at least 21 days out of 30 consecutive days. To determine patient compliance, the RPT device provider, such as a healthcare provider, may manually obtain data describing the patient's use of the RPT device, calculate usage over a predetermined time period, and compare it to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device according to the compliance rules, the healthcare provider can inform a third party that the patient is compliant.

[0074] Patient treatment may benefit from other aspects such as sending treatment data to third parties or external systems.

[0075] Existing methods for sending and managing this type of data are likely to be one or more of the following: expensive, time-consuming, and error-prone.

[0076] 2.2.3.5 Mandibular repositioning

[0077] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance, available from a dentist or other vendor, that holds the mandible (lower jawbone) in an forward position during sleep. An MRD is a removable device that is inserted into the patient's mouth before falling asleep and removed after sleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom-made or manufactured in a standardized form and include occlusal impression portions designed to fit into the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, applies tension to the pharyngeal walls to reduce airway constriction, and dampens vibrations of the hard palate.

[0078] In some instances, a mandibular advancement device may include an upper splint for engaging or engaging with teeth in the maxilla or mandible and a lower splint for engaging or engaging with teeth in the maxilla or mandible. The upper and lower splints are laterally connected by a pair of links. The pair of links are symmetrically fixed to the upper and lower splints.

[0079] In this design, the length of the link is chosen so that the mandible is held in an anteriorly protruded position when the MRD is placed in the patient's mouth. The length of the link can be adjusted to change the degree of mandibular protrusion. The dentist can determine the degree of mandibular protrusion, which will determine the length of the link.

[0080] Some MRDs are constructed to push the mandible forward relative to the maxilla, while others (such as the ResMed Narval CC™ MRD) are designed to keep the mandible in an anterior position. The device also reduces or minimizes side effects on the teeth and temporomandibular joint (TMJ). Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0081] 2.2.3.6 Vent technology

[0082] Some forms of therapeutic systems may include a vent to allow the flushing of exhaled carbon dioxide. The vent allows gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the external space of the patient interface, such as into the environment.

[0083] Ventilation ports may include openings through which air can flow when a mask is used. Many of these ventilators are noisy. Others may become blocked during use, thus providing insufficient flushing. Some ventilators can, for example, disrupt the sleep of the patient's bed partner by causing noise or congested airflow.

[0084] ResMed has developed numerous improved mask vent technologies. See International Patent Application Publication No. WO 1998 / 034665; International Patent Application Publication No. WO 2000 / 078381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0085] The noise level of the existing face mask (ISO 17510-2:2007, pressure at 1m and 10cmH2O)

[0086]

[0087] (*Only one sample, measured in CPAP mode using the test method specified in ISO 3744 at 10 cmH2O)

[0088] The sound pressure levels for various objects are listed below.

[0089]

[0090] 2.2.4 Screening, Diagnosis and Monitoring System

[0091] Polysomnography (PSG) is a routine system used for diagnosing and monitoring cardiopulmonary diseases and typically involves specialized clinicians applying the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalograms (EEG), electrocardiograms (ECG), electrooculograms (EOG), and electromyograms (EMG). For sleep-disordered breathing, PSG involves two nights of observation in a clinic: one night for pure diagnosis and the second night for titration of treatment parameters by a clinician. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0092] Screening and diagnosis are generally described as identifying a condition based on its signs and symptoms. Screening typically provides true / false results, indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis provides clinically actionable information. Screening and diagnosis tend to be one-off processes, while monitoring the progression of the condition can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0093] Clinical specialists may be able to appropriately screen, diagnose, or monitor patients based on visual observation of PSG signals. However, there may be situations where no clinical specialist is available or where they may not be able to afford one. Different clinical specialists may have differing opinions on a patient's condition. Furthermore, a given clinical specialist may apply different criteria at different times. Summary of the Invention

[0094] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0095] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0096] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0097] One aspect of certain forms of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0098] One aspect of this technology relates to a patient interface comprising: an inflatable chamber at least partially forming a patient interface chamber capable of being pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure; a sealing structure configured and arranged to seal with a region of the patient's face surrounding the patient's airway inlet; a first conduit and a second conduit, each of the first and second conduits being sized and configured to receive an airflow at therapeutic pressure for patient breathing; a first conduit connector and a second conduit connector, the first conduit connector being configured to pneumatically connect the first conduit to the inflatable chamber to provide an airflow at therapeutic pressure to the patient interface chamber for patient breathing; a second conduit connector being configured to pneumatically connect the second conduit to the inflatable chamber to provide an airflow at therapeutic pressure to the patient interface chamber for the patient breathing; a positioning and stabilizing structure providing force to secure the sealing structure in a therapeutically effective position on the patient's head; the positioning and stabilizing structure including at least one strap; and at least one anti-asphyxiation valve configured to allow the patient to breathe from the surrounding environment through their mouth without a pressurized airflow. In another instance, at least one of the first catheter connector and the second catheter connector may include an anti-asphyxiation valve.

[0099] One aspect of this technology relates to a patient interface comprising: an inflatable chamber at least partially forming a patient interface chamber capable of being pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure; the inflatable chamber including a first inflatable chamber orifice and a second inflatable chamber orifice, each of the first and second inflatable chamber orifices being sized and configured to receive an airflow at the therapeutic pressure for patient respiration; a sealing structure configured and arranged to seal with a region of the patient's face surrounding the patient's airway inlet, the sealing structure having at least one orifice therein such that an airflow at the therapeutic pressure is delivered to an inlet at least the patient's nostril; the sealing structure being configured and arranged to maintain the therapeutic pressure in the patient interface chamber during use throughout the patient's respiratory cycle; a first catheter and a second catheter, each of the first and second catheters... The dimensions and structure are configured to receive a flow of air at therapeutic pressure for patient breathing; a first catheter connector and a second catheter connector, the first catheter connector being configured to pneumatically connect the first catheter to a first inflation chamber orifice to provide a flow of air at therapeutic pressure to the patient interface chamber for patient breathing, the second catheter connector being configured to pneumatically connect the second catheter to a second inflation chamber orifice to provide a flow of air at therapeutic pressure to the patient interface chamber for patient breathing; and a positioning and stabilizing structure that provides force to secure the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including at least one strap, wherein each of the first and second catheter connectors includes an anti-asphyxiation valve configured to allow the patient to breathe from the surrounding environment through their mouth without a pressurized airflow passing through the first and second inflation chamber orifices.

[0100] In this example, (a) the anti-asphyxiation valve in each of the first and second catheter connectors may include an anti-asphyxiation valve orifice, (b) the shape and size of each anti-asphyxiation valve orifice may be configured to allow the patient to breathe through it if the other anti-asphyxiation valve orifice is blocked, (c) the anti-asphyxiation valve in each of the first and second catheter connectors may also include an anti-asphyxiation valve flap, and (d) the anti-asphyxiation valve flap in each of the first and second catheter connectors may be configured to block the anti-asphyxiation valve orifice of the corresponding one of the first and second catheter connectors when in the closed position, such that an airflow under treatment pressure traveling through the corresponding one of the first and second catheter connectors is directed to the patient interface chamber. And is prevented from escaping into the atmosphere via the anti-asphyxiation valve orifice; (e) when in the open position, the anti-asphyxiation valve flap of each of the first and second catheter connectors can be configured to allow the patient to breathe from the surrounding environment through their mouth via the anti-asphyxiation valve orifice of the corresponding one of the first and second catheter connectors without pressurized airflow passing through the first and second inflation chamber orifices; (f) the anti-asphyxiation valve orifice of each of the first and second catheter connectors can be separated by an anti-asphyxiation valve orifice separator that prevents the corresponding anti-asphyxiation valve flap from passing through the anti-asphyxiation valve orifice; (g) each anti-asphyxiation valve flap may also include at least one vent to allow a portion of the airflow at therapeutic pressure to escape through it to the atmosphere. In the atmosphere, (h) the anti-asphyxiation valve of each of the first and second catheter connectors may further include an anti-asphyxiation valve connector port, and the anti-asphyxiation valve flap of each of the first and second catheter connectors may include an anti-asphyxiation valve flap connector to connect the anti-asphyxiation valve flap to the anti-asphyxiation valve flap connector port of the corresponding anti-asphyxiation valve of the first and second catheter connectors; (i) the anti-asphyxiation valves of each of the first and second catheter connectors may be configured to operate independently of each other; (j) each of the first and second catheter connectors may include at least one catheter connector vent, the at least one catheter connector vent being configured to allow a continuous flow of exhaled gas from the patient interface chamber. (k) Each of the first and second catheter connectors may include a catheter connector vent inlet configured to guide a continuous flow of exhaled gas from the interior of the patient interface chamber to at least one catheter connector vent, (l) each of the first and second catheter connectors may include a catheter connector vent outlet configured to guide a continuous flow of exhaled gas from the interior of the patient interface chamber to the atmosphere, and (m) each of the first and second catheter connectors may include a baffle.To prevent airflow under therapeutic pressure from each of the first and second catheter connectors from directly reaching the atmosphere via at least one catheter connector vent, (n) each of the first and second catheter connectors may include a diffuser cavity containing a diffusion material, (o) the diffuser cavity and diffusion material may be positioned downstream of at least one catheter connector vent relative to the continuous gas flow so that the continuous gas flow diffuses before escaping to the atmosphere, (p) each of the first and second catheter connectors may include a diffuser cap that encloses the diffusion material within the diffuser cavity, (q) the diffuser cap may be removable to allow removal and replacement of the diffusion material, (r) the first catheter connector Each of the first and second conduit connectors may include 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 conduit connector vent outlet via a diffusion material before escaping to the atmosphere; (s) each of the first and second conduit connectors may include a conduit connector spacer to maintain a gap between a portion of each of the first and second conduit connectors and an inflation chamber to allow a continuous gas flow to escape from each of the first and second conduit connectors to the atmosphere; (t) the inflation chamber may include at least one inflation chamber vent; (u) the inflation chamber may include a plurality of inflation chamber vents; (v) the first and second conduit connectors... Each of the connectors may include a catheter connection end configured to connect to a corresponding one of the first and second catheters; (w) each of the first and second catheter connectors may include a catheter connector end defining a catheter connector inlet orifice configured to receive a flow of air under therapeutic pressure from a corresponding one of the first and second catheters; (x) each of the first and second catheter connectors may include a catheter connector outlet defining a catheter connector outlet orifice configured to direct the flow of air under therapeutic pressure into the patient interface chamber; and (y) each catheter connector end may be oriented substantially perpendicular to the corresponding one of the first and second catheters. The corresponding conduit connector outlet, (z) the inflation chamber may include a connecting edge located at a corresponding location in one of the first inflation chamber orifice and the second inflation chamber orifice, and each of the first conduit connector and the second conduit connector may include at least one conduit connector attachment structure configured to connect to the connecting edge located at a corresponding location in one of the first inflation chamber orifice and the second inflation chamber orifice, (aa) each of the first conduit connector and the second conduit connector may be removable from the inflation chamber, (bb) each of the first conduit connector and the second conduit connector may be permanently connected to the inflation chamber, and (cc) each of the first conduit connector and the second conduit connector is configured to remain stationary when connected to the inflation chamber.(dd) The patient interface may further include a seal between each of the first and second catheter connectors and a corresponding one of the first and second air chamber orifices, (ee) the seal may be formed on each of the first and second catheter connectors, the seal being configured to engage an air chamber at the corresponding one of the first and second air chamber orifices, (ff) the seal may be permanently attached to the corresponding one of the first and second catheter connectors, (gg) the seal may be made of silicone, and (hh) the positioning and stabilizing structure may include a pair of upper ties, each of the upper ties being constructed and arranged such that at least a portion of the upper ties covers the patient's head in use. The corresponding transverse region located above the upper ear base point on the patient's head, and the positioning and stabilizing structure may include a pair of lower frenulum, each of which is constructed and arranged such that at least a portion of the lower frenulum covers, in use, the corresponding transverse region of the patient's head located below the lower ear base point on the patient's head; (ii) each of the first catheter connector and the second catheter connector may include a lower frenulum connector configured to connect to a corresponding one of the lower frenulum; (jj) a clip may releasably connect each of the lower frenulum to the corresponding one of the lower frenulum connectors; (kk) the clip may include a magnet; (ll) the patient interface may also include a pair of lower frenulum tabs, the lower frenulum... Each of the tabs is configured to connect to a corresponding one in the frenulum, and each of the first catheter connector and the second catheter connector may further include a flange configured to connect to a corresponding one in the frenulum tabs, (mm) each of the flanges may further include a flange opening and a recess, each of the frenulum tabs may further include a tab connector configured to connect each of the frenulum tabs to a corresponding one in the flange by passing through the corresponding flange opening and engaging the corresponding recess, (nn) the patient interface may further include a clip configured to connect to each of the frenulum tabs, each of the frenulum tabs may further include a clip receiver configured to Each of the clips and each of the clip receivers may include a magnet, which is oriented and charged to facilitate a removable connection. Each of the clip receivers may include a notch, and each clip includes a protrusion configured to engage a corresponding notch to restrict rotation of the clip relative to the corresponding clip receiver. Each of the first and second conduit connectors may further include a first tab and a second tab to releasably connect the first and second conduit connectors to an inflation chamber at a first inflation chamber orifice and a second inflation chamber orifice, respectively.(rr) The first and second tabs can be configured such that the first and second conduit connectors can be connected to the inflation chamber only by engaging the first tab with the inflation chamber and subsequently engaging the second tab with the inflation chamber; (ss) The first and second tabs can be configured such that the first and second conduit connectors can be disconnected from the inflation chamber only by disengaging the second tab from the inflation chamber and subsequently disengaging the first tab from the inflation chamber; (tt) The inflation chamber may further include a slot adjacent to each of the first and second inflation chamber orifices; the first tab of each of the first and second conduit connectors can be configured to engage with... A slot associated with a corresponding one of the first and second inflation chamber holes, and each of the first and second conduit connectors is rotatable about the corresponding slot when the first tab of each of the first and second conduit connectors engages with the corresponding slot. The inflation chamber may also include a latch adjacent to each of the first and second inflation chamber holes, and the second tab of each of the first and second conduit connectors may also include a snap-fit, configured to engage the latch associated with the corresponding one of the first and second inflation chamber holes in a snap-fit ​​configuration. The second tab of each of the second catheter connectors may be flexible. Each of the first and second catheter connectors may also include gaps on each side of the corresponding second tab, such that the second tab extends cantilevered from each of the first and second catheter connectors. The sealing structure may include a nasal portion configured to seal around a patient's nostril and an oral portion configured to seal around a patient's mouth. The sealing structure may include a nasal orifice configured to provide pneumatic communication between the patient's nostril and a patient interface chamber, and the sealing structure may include an oral portion orifice. Configured to provide pneumatic communication between the patient's mouth and the patient interface chamber, the (zz) patient interface may include a connection port housing, each of a first and a second conduit pneumatically communicating with the connection port housing, and a connection port connected to the connection port housing, the connection port being configured to connect to an air circuit to receive airflow at therapeutic pressure, (aaa) the connection port may include a bend, (bbb) the connection port may include at least one vent, (ccc) the connection port may be rotatably connected to the connection port housing, and / or (ddd) the connection port and the connection port housing may be configured to be positioned above the patient's head during use.

[0101] Another aspect of this technology relates to a respiratory therapy system that may include: a patient interface as described in any of the preceding three paragraphs; a respiratory pressure therapy device configured to generate an airflow at a therapeutic pressure; and an air circuit configured to direct the airflow at the therapeutic pressure from the respiratory pressure therapy device to the patient interface.

[0102] Another aspect of this technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0103] One aspect of this technology is a method for manufacturing equipment.

[0104] One aspect of certain forms of this technology is a medical device that is easy to use, for example, by people who have no medical training, limited dexterity, limited vision, or limited experience in using such medical devices.

[0105] One aspect of this technology is a portable RPT device that can be carried by an individual (e.g., around a personal home).

[0106] One aspect of this technology is a patient interface that can be cleaned at home, for example, in soapy water, without requiring specialized cleaning equipment. Another aspect of this technology is a humidifier tank that can be cleaned at home, for example, in soapy water, without requiring specialized cleaning equipment.

[0107] The methods, systems, apparatuses, and devices described herein can be implemented to improve the functionality of processors (e.g., processors in dedicated computers, respiratory monitors, and / or respiratory therapy devices). Furthermore, the described methods, systems, apparatuses, and devices can provide improvements in the field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0108] Of course, parts of these aspects can form sub-aspects of this technology. Furthermore, the various sub-aspects and / or aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0109] Other features of the present technology will be apparent from the following detailed description, the information contained in the abstract, the drawings, and the claims. Attached Figure Description

[0110] This technology is illustrated by way of example rather than limitation in the various figures of the accompanying drawings, wherein the same reference numerals denote similar elements, including:

[0111] 4.1 Treatment System

[0112] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient is sleeping in a supine position.

[0113] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0114] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a lateral decubitus position.

[0115] 4.2 Respiratory System and Facial Anatomy

[0116] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0117] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, pharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0118] Figure 2C It is a frontal view of a face with several marked surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0119] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, lower nasal septum, upper lip, lower lip, supramental point, bridge of the nose, apex of the nostrils, upper ear base, and lower ear base. The vertical and horizontal directions are also indicated.

[0120] Figure 2E This is another side view of the head. The approximate locations of the Frankfurt plane and the nasolabial angle are indicated. The coronal plane is also marked.

[0121] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial folds, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and midsagittal plane.

[0122] Figure 2G A side view showing the surface features of the nose.

[0123] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilages, septal cartilages, greater alar cartilages, lesser alar cartilages, sesamoid cartilages, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0124] Figure 2I A medial anatomical view of the nose is shown, approximately several millimeters from the midsagittal plane, including the medial crus of the septal cartilage and the greater alar cartilage.

[0125] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also labeled.

[0126] Figure 2K A side view of the skull showing the surface outline of the head and several muscles is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0127] Figure 2L The frontal lateral view of the nose is shown.

[0128] 4.3 Patient Interface

[0129] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0130] Figure 3B A schematic diagram of a cross-section passing through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature values ​​shown have a relatively large value compared to the values ​​shown.

[0131] Figure 3C A schematic diagram of a cross-section passing through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature values ​​shown are relatively small compared to those of the time period.

[0132] Figure 3DA schematic diagram of a cross-section passing through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a zero value.

[0133] Figure 3E A schematic diagram of a cross-section passing through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature values ​​shown are relatively small compared to those of the time period.

[0134] Figure 3F A schematic diagram of a cross-section passing through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature values ​​shown have a relatively large value compared to the values ​​shown.

[0135] Figure 3G A cushion for a face mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome-shaped and saddle-shaped areas are indicated.

[0136] Figure 3H The pad used for the face mask is shown. The outer surface of the pad is indicated. The edges of the surface are indicated. The path on the surface between points A and B is indicated. The straight-line distance between points A and B is indicated. Two saddle-shaped areas and one dome-shaped area are indicated.

[0137] Figure 3I The surface of the structure is shown, in which a one-dimensional hole is present. The planar curve shown forms the boundary of the one-dimensional hole.

[0138] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface shown defines... Figure 3I Two-dimensional holes in the structure.

[0139] Figure 3K It shows Figure 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is the definition of... Figure 3I The surface of a two-dimensional hole in a structure.

[0140] Figure 3L A face mask with an inflatable bladder-like structure as a cushion is shown.

[0141] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the capsule is also shown. This inner surface defines a two-dimensional opening in the mask.

[0142] Figure 3N It shows crossing Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0143] Figure 3O The left-hand rule is shown.

[0144] Figure 3P The right-hand rule is shown.

[0145] Figure 3Q The left ear is shown, including the left ear spiral.

[0146] Figure 3R The right ear is shown, including the right ear spiral.

[0147] Figure 3S A right-handed spiral is shown.

[0148] Figure 3T A view of the face mask is shown, which includes symbols representing the twisting of spatial curves defined by the edges of sealing membranes in different areas of the face mask.

[0149] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0150] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The direction of this view is perpendicular to the central contact plane. Figure 3V The sagittal plane in the middle divides the air chamber into two equal parts: the left-hand side and the right-hand side.

[0151] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, which is in Figure 3V The image shows a section taken at the sagittal plane. The 'intermediate contact' plane is shown. The intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of chord 3210, which lies in the sagittal plane and contacts the pad of the inflation chamber at exactly two points in the sagittal plane: the upper point 3220 and the lower point 3230. Depending on the geometry of the pad in this region, the intermediate contact plane can be a section at both the upper and lower points.

[0152] Figure 3X It shows Figure 3U The position of the inflation chamber 3200 on the face. When the inflation chamber is in the use position, the sagittal plane of the inflation chamber 3200 approximately coincides with the midsagittal plane of the face. When the inflation chamber is in the use position, the intermediate contact plane approximately corresponds to the 'plane of the face'. Figure 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is located approximately on the bridge of the nose, while the lower point 3230 is located on the upper lip.

[0153] 4.4RPT device

[0154] Figure 4A An RPT device of one form according to the present technology is shown.

[0155] Figure 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to the blower and patient interface. The blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower, regardless of the actual flow direction at any given moment. Items within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0156] Figure 4C This is a schematic diagram of the electrical components of one form of RPT device according to the present technology.

[0157] 4.5 Humidifier

[0158] Figure 5A An isometric view of one form of humidifier according to the present technology is shown.

[0159] Figure 5B An isometric view of one form of humidifier according to the present technology is shown, illustrating the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0160] Figure 5C A schematic diagram of one form of humidifier according to the present technology is shown.

[0161] 4.6 Respiratory waveform

[0162] Figure 6 The diagram shows a typical breathing waveform of a person during sleep.

[0163] 4.7 Examples of this technology

[0164] Figure 7 A front perspective view of a patient interface according to an example of this technology is depicted.

[0165] Figure 8 A rear perspective view of a patient interface according to an example of this technology is depicted.

[0166] Figure 9 A bottom view of a patient interface according to an example of this technology is depicted.

[0167] Figure 10 A front view of a patient interface according to an example of this technology is depicted.

[0168] Figure 11 A rear view of a patient interface according to an example of this technology is depicted.

[0169] Figure 12 Depicting crossing Figure 11 The line 12-12 is a cross-sectional view of the patient interface according to an example of this technology.

[0170] Figure 13 A side view of a patient interface according to an example of this technology is depicted.

[0171] Figure 14 Depicting crossing Figure 13 The lines 14, 15-14, 15 are cross-sectional views of a patient interface according to an example of this technology.

[0172] Figure 15 Depicting crossing Figure 13 The lines 14, 15-14, 15 are cross-sectional views of a patient interface according to an example of this technology.

[0173] Figure 16 A front perspective view of a patient interface according to an example of this technology is depicted.

[0174] Figure 17 A rear perspective view of a patient interface according to an example of this technology is depicted.

[0175] Figure 18 A top view of a patient interface according to an example of this technology is depicted.

[0176] Figure 19 A front perspective view depicting a subcomponent of a patient interface according to an example of this technology is provided.

[0177] Figure 20 A front view of a subcomponent of the patient interface according to an example of this technology is depicted.

[0178] Figure 21 A back perspective view depicting a sub-component of a patient interface according to an example of this technology is shown.

[0179] Figure 22 A rear view of a sub-component of a patient interface according to an example of this technology is depicted.

[0180] Figure 23 Depicting crossing Figure 22 Lines 23-23 are cross-sectional views of a sub-component of the patient interface according to an example of this technology.

[0181] Figure 24 A side view of a sub-component of a patient interface according to an example of this technology is depicted.

[0182] Figure 25 A front perspective view of a catheter connector for a patient interface according to an example of this technology is depicted.

[0183] Figure 26 A rear perspective view of a catheter connector for a patient interface according to an example of the present technology is depicted.

[0184] Figure 27 A side perspective view of a catheter connector for a patient interface according to an example of the present technology is depicted.

[0185] Figure 28 A top view of a catheter connector for a patient interface according to an example of the present technology is depicted.

[0186] Figure 29 Depicting crossing Figure 28 Lines 29,30–29,30 show a cross-sectional view of a catheter connector for a patient interface according to an example of this technology.

[0187] Figure 30 Depicting crossing Figure 28 Lines 29,30–29,30 show a cross-sectional view of a catheter connector for a patient interface according to an example of this technology.

[0188] Figure 31 A front perspective view of a catheter connector for a patient interface according to an example of this technology is depicted.

[0189] Figure 32 A front perspective view of a patient interface according to an example of this technology is depicted.

[0190] Figure 33 A front view of a patient interface according to an example of this technology is depicted.

[0191] Figure 34 A front perspective view of a patient interface according to an example of this technology, worn by a patient, is depicted.

[0192] Figure 35 A side view depicts a patient interface worn by a patient according to an example of this technology.

[0193] Figure 36 A front perspective view of a patient interface according to an example of this technology, worn by a patient, is depicted.

[0194] Figure 37 A top perspective view depicting the connection port of a patient interface according to an example of this technology is shown.

[0195] Figure 38 A bottom perspective view depicting the connection port of a patient interface according to an example of this technology is shown.

[0196] Figure 39A front perspective view of a patient interface according to an example of this technology is depicted.

[0197] Figure 40 A rear perspective view of a patient interface according to an example of this technology is depicted.

[0198] Figure 41 A bottom view of a patient interface according to an example of this technology is depicted.

[0199] Figure 42 A front view of a patient interface according to an example of this technology is depicted.

[0200] Figure 43 A rear view of a patient interface according to an example of this technology is depicted.

[0201] Figure 44 Depicting crossing Figure 43 Lines 44-44 are a cross-sectional view of the patient interface according to an example of this technology.

[0202] Figure 45 A side view of a patient interface according to an example of this technology is depicted.

[0203] Figure 46 Depicting crossing Figure 45 The lines 46, 47-46, 47 are cross-sectional views of a patient interface according to an example of this technology.

[0204] Figure 47 Depicting crossing Figure 45 The lines 46, 47-46, 47 are cross-sectional views of a patient interface according to an example of this technology.

[0205] Figure 48 A front perspective view of a patient interface according to an example of this technology is depicted.

[0206] Figure 49 A rear perspective view of a patient interface according to an example of this technology is depicted.

[0207] Figure 50 A top view of a patient interface according to an example of this technology is depicted.

[0208] Figure 51 A front perspective view depicting a subcomponent of a patient interface according to an example of this technology is provided.

[0209] Figure 52 A front view of a subcomponent of the patient interface according to an example of this technology is depicted.

[0210] Figure 53A back perspective view depicting a sub-component of a patient interface according to an example of this technology is shown.

[0211] Figure 54 A rear view of a sub-component of a patient interface according to an example of this technology is depicted.

[0212] Figure 55 Depicting crossing Figure 54 The line 55-55 is a cross-sectional view of a sub-component of the patient interface according to an example of this technology.

[0213] Figure 56 A rear perspective view of a catheter connector for a patient interface according to an example of the present technology is depicted.

[0214] Figure 57 An exploded rear perspective view of a catheter connector for a patient interface according to an example of the present technology is depicted.

[0215] Figure 58 An exploded front perspective view of a catheter connector for a patient interface according to an example of the present technology is depicted.

[0216] Figure 59 A top view of a catheter connector for a patient interface according to an example of the present technology is depicted.

[0217] Figure 60 Depicting crossing Figure 58 The lines 59, 60–59, 60 are cross-sectional views of a catheter connector for a patient interface according to an example of this technology.

[0218] Figure 61 Depicting crossing Figure 58 The lines 59, 60–59, 60 are cross-sectional views of a catheter connector for a patient interface according to an example of this technology.

[0219] Figure 62 A front perspective view of a catheter connector for a patient interface according to an example of this technology is depicted.

[0220] Figure 63 Another cross-sectional view depicts a catheter connector connected to a patient interface of a catheter, according to an example of the present technology.

[0221] Figure 64 A front view of a patient interface according to an example of this technology is depicted.

[0222] Figure 65 A front perspective view of a patient interface according to an example of this technology is depicted.

[0223] Figure 66A rear view depicting the positioning and stabilization structure according to an example of this technology is shown.

[0224] Figure 67 A perspective view of a clip according to an example of this technology is depicted.

[0225] Figure 68 A perspective view of a clip according to an example of this technology is depicted. Detailed Implementation

[0226] Before describing the invention in further detail, it should be understood that the invention is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein and is not intended to be limiting.

[0227] The following description relates to various instances that may share one or more common features and / or characteristics. It should be understood that one or more features of any instance may be combined with one or more features of another instance or other instances. Furthermore, in any instance, any single feature or combination of features may constitute a further instance.

[0228] 5.1 Treatment

[0229] In one form, the technology includes a method for treating respiratory disorders, the method comprising the step of applying positive pressure to the inlet of the airway of a patient 1000.

[0230] In some instances of this technique, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0231] In some instances of this technology, mouth breathing is limited, restricted, or prevented.

[0232] 5.2 Treatment System

[0233] In one form, the technology includes a device or apparatus for treating respiratory disorders. The device or apparatus may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 leading to a patient interface 3000.

[0234] 5.3 Patient Interface

[0235] According to one aspect of the present technology, the noninvasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, a functional aspect may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged around the inlet of the patient's airway to facilitate the supply of positive pressure air to the airway.

[0236] If the patient interface cannot comfortably deliver the minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0237] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply with a positive pressure of at least 6 cmH2O relative to the environment.

[0238] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply with a positive pressure of at least 10 cmH2O relative to the environment.

[0239] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply with a positive pressure of at least 20 cmH2O relative to the environment.

[0240] 5.3.1 Sealing Formation Structure

[0241] In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual sealing surface—may vary daily during a given treatment period and vary from patient to patient, depending on a range of factors, including, for example, the position of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0242] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0243] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material such as silicone rubber.

[0244] The sealing structure 3100 according to this technology can be constructed from a soft, flexible and elastic material such as silicone.

[0245] In some forms of this technology, a system is provided that includes more than one seal forming structure 3100, each seal forming structure 3100 configured to correspond to a different range of sizes and / or shapes. For example, the system may include one type of seal forming structure 3100 that is suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0246] 5.3.1.1 Sealing Mechanism

[0247] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure acting within the inflation chamber 3200 on its underside, thereby forming a tight seal with the face. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0248] In one embodiment, the sealing 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, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends for at least a portion of the path around the periphery. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from bending during use.

[0249] In one form, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or gasket seal portion is constructed and arranged in a compressed state, for example, due to elastic tension in the positioning and stabilizing structure.

[0250] In one form, the seal forming structure includes a tensioning portion. In use, the tensioning portion is held taut, for example, by adjacent areas of the sealing flange.

[0251] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0252] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having an adhesive or bonding surface.

[0253] 5.3.1.2 Nasal bridge or nasal ridge area

[0254] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the bridge or ridge of the nose of the patient's face during use.

[0255] In one form, the sealing structure includes a saddle-shaped region configured to form a seal on the bridge or ridge of the nose of a patient's face during use.

[0256] 5.3.1.3 Upper lip area

[0257] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face during use.

[0258] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip region of a patient's face during use.

[0259] 5.3.1.4 Chin region

[0260] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the chin region of the patient's face during use.

[0261] In one form, the sealing structure includes a saddle-shaped region configured to form a seal on the chin area of ​​a patient's face during use.

[0262] 5.3.1.5 Forehead area

[0263] In one form, the sealing structure forms a seal on the forehead area of ​​the patient's face during use. In this form, the inflatable chamber can cover the eyes during use.

[0264] 5.3.1.6 Nasal pillow

[0265] In one form, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is constructed and arranged to form a seal with the corresponding nostril of the patient's nose.

[0266] A nasal pillow according to one aspect of the present invention includes: a truncated cone, at least a portion of which forms a seal on the underside of the patient's nose; a handle; and a flexible region located on the underside of the truncated cone and connecting the truncated cone to the handle. Furthermore, the structure connected to the nasal pillow of the present invention includes a flexible region adjacent to the base of the handle. The flexible regions can work together to facilitate the formation of a universal joint structure capable of accommodating both displacement and angular movement of the truncated cone and the structure connected to the nasal pillow. For example, the truncated cone can be axially moved toward the structure connected to the handle.

[0267] 5.3.1.7 Sealing structure 3100 of this technology

[0268] According to an example of this technology, the sealing structure 3100 can seal around the patient's nostrils and mouth, i.e., the mouth and nose.

[0269] The sealing structure 3100 may include a nose portion 3101 having a pair of nasal openings 3103 for sealing with the patient's nostrils. The depicted example provides one nasal opening 3103 to provide airflow to both of the patient's nostrils. In an alternative example, the nasal opening 3103 may be divided into two separate openings, each corresponding to one of the patient's nostrils, and a portion of the nose portion 3101 may separate these two separate openings.

[0270] The sealing structure 3100 may include an oral portion 3102 having an oral portion hole 3104 for sealing with the patient's mouth.

[0271] The sealing structure 3100 can at least partially form the patient interface chamber 3001, which is pressurized by an airflow. An inflation chamber 3200 can be connected to the sealing structure 3100 to further form the patient interface chamber 3001.

[0272] 5.3.2 Inflation Chamber

[0273] In the area where a seal is formed during use, the air chamber 3200 has a periphery shaped to complement the surface contours of a typical human face. During use, the edge of the air chamber 3200 is positioned very close to the adjacent surface of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 can extend along the entire periphery of the air chamber 3200 during use. In some forms, the air chamber 3200 and the sealing structure 3100 are formed from a single sheet of homogeneous material.

[0274] In some forms of this technology, the air chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the air chamber. This form is less obtrusive and / or more comfortable for the wearer, which can improve treatment adherence.

[0275] In some forms of this technology, the air chamber 3200 is made of a transparent material, such as transparent polycarbonate. Using a transparent material reduces the obtrusiveness of the patient interface and helps improve treatment adherence. It also helps clinicians observe how the patient interface is positioned and functions.

[0276] In some forms of this technology, the air chamber 3200 is made of a translucent material. Using a translucent material can reduce the obtrusiveness of the patient interface and help improve treatment adherence.

[0277] An inflation chamber 3200 according to an embodiment of the present technology may include an inflation chamber aperture 3201 on each side. The inflation chamber aperture 3201 may provide pneumatic communication between the catheter connector 3800 (which will be described in more detail below) and the patient interface chamber 3001. The inflation chamber 3200 may include a connecting edge 3202 surrounding each inflation chamber aperture 3201. The connecting edge 3202 may facilitate a mechanical connection with the corresponding catheter connector, such as a snap-fit ​​or friction fit. The inflation chamber 3200 may be constructed of a sufficiently rigid material to provide auditory and / or tactile feedback to the patient when the catheter connector 3800 is attached to or removed from the inflation chamber 3200.

[0278] The sealing structure 3100 can be connected to the inflation chamber 3200. This connection can be permanent, or the sealing structure 3100 can be removed from the inflation chamber 3200. The sealing structure 3100 can be overmolded into the inflation chamber 3200. The sealing structure 3100 and the inflation chamber 3200 can be mechanically interlocked, wherein no chemical bond is formed between the inflation chamber 3200 and the sealing structure 3100.

[0279] 5.3.3 Positioning and Stabilization Structure

[0280] The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by the positioning and stabilizing structure 3300.

[0281] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the lifting effect of the positive pressure in the inflation chamber 3200 on the face.

[0282] In one configuration, the positioning and stabilizing structure 3300 provides a holding force to overcome the gravitational effects on the patient interface 3000.

[0283] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of disturbances on the patient interface 3000, such as those from tube drag or accidental interference with the patient interface.

[0284] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured to be worn by a patient during sleep. In one example, the positioning and stabilization structure 3300 has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one example, the positioning and stabilization structure 3300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0285] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured not to be too large and bulky to prevent the patient from lying supine with the back of the patient's head resting on a pillow.

[0286] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured not to be too large and bulky to prevent the patient from lying flat in a lateral position with the side of the patient's head resting on the pillow.

[0287] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and may be, for example, a flexible or loose bandage. The decoupling portion is constructed and arranged such that when the patient lies supine with their head resting on the pillow, the presence of the decoupling portion prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0288] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminated material comprising a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In another embodiment, the fabric outer layer includes a loop material for engagement with the hook material portion.

[0289] In some forms of this technology, the positioning and stabilizing structure 3300 includes an extendable, for example, elastically extendable, strap. For instance, the strap may be configured to be tensioned during use and to channel force to pull the sealing structure into sealed contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0290] In one form of the technology, the positioning and stabilizing structure includes a first frenulum, which is constructed and arranged such that, in use, at least a portion of its lower edge passes over the supraaural base of the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0291] In one form of the technology applicable to nasal masks only or to full-face masks, the positioning and stabilizing structure includes a second strap that is configured and arranged such that, in use, at least a portion of its upper edge passes below the subauricular base of the patient's head and covers or is located below the occipital bone of the patient's head.

[0292] In one form of the technology applicable to nose masks only or to full-face masks, the positioning and stabilizing structure includes a third strap that is configured and arranged to connect the first and second straps to each other to reduce the tendency of the first and second straps to separate from each other.

[0293] In some forms of this technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. An advantage of this is that the patient is more comfortable lying flat while wearing the strap during sleep.

[0294] In some forms of this technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow moisture to pass through them.

[0295] In some forms of this technology, a system is provided comprising more than one positioning and stabilizing structure 3300, each positioned and stabilizing structure 3300 being configured to provide a retaining force to correspond to different size and / or shape ranges. For example, the system may include one type of positioning and stabilizing structure 3300 that is suitable for large-sized heads but not for small-sized heads, while another is suitable for small-sized heads but not for large-sized heads.

[0296] The positioning and stabilizing structure 3300 may include a clip 3301 to secure a corresponding strap, for example, to the conduit connector 3800, such as... Figures 32 to 36 As shown. Clip 3301 and conduit connector 3800 may each include magnets 3305 arranged with opposite polarities to facilitate connection between them. Clip 3301 may also include a crossbar 3306, with a lower strap 3303 passing over the crossbar 3306 to secure clip 3301 thereto.

[0297] Figure 66 An exemplary positioning and stabilizing structure 3300 is depicted, which may include an upper tether 3302, a lower tether 3303, and a rear portion 3304.

[0298] 5.3.4 Vent

[0299] In one embodiment, the patient interface 3000 includes a ventilation port 3400, which is configured and arranged to allow flushing of exhaled gas, such as carbon dioxide.

[0300] In some configurations, the airway 3400 is configured to allow a continuous airflow from the interior of the inflation chamber 3200 to the surrounding environment when the pressure within the inflation chamber is positive relative to the surrounding environment. The airway 3400 is configured such that, during use, the airflow rate is sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining the therapeutic pressure within the inflation chamber.

[0301] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0302] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a decoupling structure, such as a rotating shaft.

[0303] Figure 32 and 33 An example of a vent 3400 provided on a connection port 3600 is shown. Variations of these examples may exclude the vent 3400 from the connection port 3600.

[0304] The catheter connector 3800, which will be described in more detail below, may also include a vent feature.

[0305] 5.3.5 Decoupling Structure

[0306] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball head and a ball socket.

[0307] 5.3.6 Connection Port

[0308] Connection port 3600 allows connection to air circuit 4170. According to an embodiment of the present technology, connection port 3600 can be connected to connection port housing 3903. Connection port 3600 is rotatable relative to connection port housing 3903, and the connection to air circuit 4170 can also be rotatable.

[0309] In use, the connection port 3600 and the connection port housing 3903 can be positioned above the patient's head.

[0310] Figure 37 and 38 Connection port 3600 of a patient interface 6000 according to another example of the present technology is shown. Although the present technology has been described with reference to patient interface 6000, it should be understood that the present technology is not limited to such a particular instance and may be adapted for use in other suitable interface arrangements and types.

[0311] In the example shown, the connection port 3600 is constructed and arranged to provide a releasable connection between the patient interface 6000 and the air circuit 4170.

[0312] Connection port 3600 includes a bend assembly 7700 and a ring member 7900, the bend assembly 7700 being configured to connect to air circuit 4170 (e.g., via spindle connector 7790), and the ring member 7900 being configured to connect to patient interface 6000. As described in more detail below, the bend assembly 7700 can be repeatedly engaged with and removably disengaged from the ring member 7900 (i.e., can be connected to and disconnected from the ring member 7900) to facilitate a releasable or detachable connection between the remainder of patient interface 3000 and air circuit 4170.

[0313] 5.3.6.1 Pipe Bending Assembly

[0314] The pipe bending assembly 7700 includes a pipe bending member 7710 having a first end and a second end. In the illustrated example, the pipe bending member 7710 includes a 90° bend such that the first end is substantially perpendicular to the second end, i.e., the central axis of the first end is at a 90° angle to the central axis of the second end. However, it should be understood that the first end and the second end can be arranged in alternative configurations, for example, at angles that are not perpendicular to each other.

[0315] A clamp member 7730 is disposed at the first end. In the illustrated example, the clamp member 7730 is configured and arranged to provide a releasable connection with the ring member 7900, for example, a releasable snap-fit ​​connection or a detachable snap-engagement assembly. A swivel connector 7790 (e.g., a swivel connector 7790 permanently attached to the second end) is disposed at the second end, the swivel connector 7790 being adapted to connect to the air circuit 4170.

[0316] Furthermore, 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 bend member 7710 to allow exhaust gas to exit from the patient interface 3000. As shown, the vents 7720 are arranged in a row; however, it should be understood that the vents can be arranged in other suitable manner, e.g., concentrically. In one example, each vent 7720 may include a profile or cone shape, such as a polygon, along its length, with each hole converging in the direction of exhaust gas. However, each vent 7720 may have other suitable shapes to guide exhaust gas or flushing gas. Furthermore, in the illustrated example, the vents 7720 may be positioned on a portion of a generally flat or planar rear wall such that the outlet end of each vent is positioned along a generally flat or planar surface. However, it should be understood that the vents 7720 may be positioned on a portion of the bend member 7710 having other shapes (e.g., circular or convex).

[0317] The clamp component 7730 includes a pair of resilient, quick-release clamping arms 7740 and a connecting portion 7760, the connecting portion 7760 connecting the clamping arms 7740, i.e., the clamping arms 7740 disposed at each end of the connecting portion 7760 to each other.

[0318] Each clamping arm 7740 includes a snap-fit ​​portion 7750 and a button or trigger portion 7780. The clamping arm 7740 is configured and arranged to provide a releasable snap-fit ​​engagement with or a detachable snap-fit ​​assembly with the ring member 7900, for example, configured to deflect and engage the snap-fit ​​portion 7750 in a notch or undercut on the ring member 7900. The button portion 7780 is configured and arranged to be manually pressed or squeezed to deflect the snap-fit ​​portion 7750 to disengage or release it from the ring member 7900, thus allowing the bend assembly 7700 to disengage from the ring member 7900.

[0319] Each snap-fit ​​portion 7750 includes a barb end, rib, or snap configured to provide snap-fit ​​engagement with the ring member 7900. Each button or trigger portion 7780 includes a finger grip portion 7781, such as a recessed portion adjacent to the free end of the clamping arm 7740.

[0320] In the illustrated example, the clip member 7730 and the bend member 7710 include separately molded components (i.e., separate and distinct structures) that are subsequently joined together, for example, by a snap-fit ​​connection. For instance, the clip member 7730 may be made of a more flexible material than the material of the bend member 7710, thereby allowing the clip member 7730 to bend onto and connect to a first end of the bend member 7710. In one example, a retaining arrangement is provided to connect or secure the clip member to the bend member, for example, by a snap-fit ​​connection or a snap-engagement assembly.

[0321] In the illustrated example, the clip member 7730 includes an open-end construction with a semi-flexible and generally semi-circular connecting portion 7760 that allows the clip member 7730 to be connected to the bent tube member 7710, for example, in a manner similar to a snap ring.

[0322] In one example, the snap-fit ​​portion 7750 of the clamp member 7730 can be biased inward such that when the clamp member 7730 is attached to the bend member 7710, the snap-fit ​​portion 7750 is biased inward to grip the bend member 7710 and further provide resistance to resist removal from the bend member 7710.

[0323] In the illustrated example, the bent tube member 7710 and the clamp member 7730 provide an assembly or construction comprising two parts. An exemplary advantage of this two-part construction is that it allows for less restriction on materials during manufacturing. For example, the clamp member 7730 and the bent tube member 7710 comprise separately molded parts, resulting in less interdependence between the clamp member 7730 and the bent tube member 7710; for example, the clamp member 7730 is not limited by the material of the bent tube member 7710. In one example, the clamp member 7730 and the bent tube member 7710 comprise different materials and / or different material properties relative to each other. In one example, the clamp member 7730 and the bent tube member 7710 are not molded integrally from the same material.

[0324] In one example, the bend member 7710 may be made of a more rigid material (e.g., polycarbonate) than the material of the clamp member 7730 (e.g., nylon-12). The material of the clamp member 7730 (e.g., nylon-12) may be relatively flexible yet strong, for example, facilitating the flexing of the clamping arm, being abrasion-resistant, and maintaining the connection with the bend member. The material of the bend member 7710 (e.g., polycarbonate) may be relatively rigid, for example, abrasion-resistant, transparent for easy cleaning, and easy to manufacture.

[0325] Furthermore, the two-part construction allows for lower geometric complexity in each part, resulting in components that can be manufactured using simpler tools.

[0326] In the illustrated example, the clamp member 7730 is constructed and arranged to provide a releasable connection, such as a snap-fit ​​connection, to the bend member 7710. This releasable or separable arrangement facilitates cleaning of both the clamp member 7730 and the bend member 7710 upon separation.

[0327] In an alternative embodiment, the clip member 7730 may be non-removably attached to the bend member 7710; for example, the clip member may be permanently attached to the bend member. This non-removable arrangement can be advantageous because it reduces the likelihood of the clip member being lost or broken. Since the clip member is located outside the airflow path, thorough cleaning may not be necessary, for example, compared to components exposed to the airflow path.

[0328] In one example, the clamp member 7730 and the bend member 7710 may comprise separately molded components that are subsequently permanently joined together, such that the clamp member 7730 may be inseparable from the bend member 7710. Any suitable means may be used to permanently engage or connect the clamp member and the bend member.

[0329] In one example, the clamp member 7730 and the bend member 7710 can be welded or bonded to each other, for example, by ultrasonic welding. For instance, the clamp member 7730 can be attached to the bend member 7710 as described above, and then one or more portions (e.g., the central portion) of the connecting portion 7760 of the clamp member 7730 can be welded or bonded to the bend member 7710 to permanently secure the clamp member to the bend member. This connection will allow the connecting portion to provide sufficient torsion (and torsional resistance) to operate the clamping arm 7740.

[0330] Alternatively, the bend assembly can be configured to allow the clamp component to be easily assembled to the bend assembly, but the structure of the bend assembly and / or clamp component makes disassembly difficult or challenging. Such a bend assembly with separately manufactured bend and clamp components can achieve the desired advantages (e.g., fewer restrictions on material selection) while avoiding additional welding or bonding operations to secure the clamp component to the bend assembly.

[0331] The ring member 7900 is configured to be removably and hermetically secured in an opening or orifice of the connection port housing 3903. The bend assembly 7700 is releasably connected to the ring member 7900 via a clamping arm 7740, for example, by a snap-fit ​​or snap-engage assembly.

[0332] Connection port 3600 provides decoupling of air circuit 4170 from patient interface (e.g., patient interface), for example to enhance tube drag decoupling on patient interface, thereby preventing seal instability.

[0333] The clamping arm 7740 provides a decoupling form, forming a rotatable connection that allows the bend assembly 7700 to rotate freely 360° relative to the ring member 7900. The swivel connector 7790 provides another decoupling form, allowing the swivel connector 7790 (and the air circuit 4170 connected thereto) to rotate freely 360° relative to the bend member 7710.

[0334] 5.3.7 Forehead Stent

[0335] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0336] Figures 7 to 36 The patient interface example shown does not include a forehead stent. Variations of the patient interface of this technology may include a forehead stent.

[0337] 5.3.8 Catheter

[0338] The patient interface 3000 according to an embodiment of the present technology may include a catheter 3900 to provide a pressurized flow from a connection port 3600 to a patient interface chamber 3001. The catheter 3900 may be connected above the patient's head at a connection port housing 3903 and may pass along the side of the patient's head between the corresponding eyes and ears. The catheter 3900 may be connected via a catheter connector 3800 to an inflation chamber 3200 (described below) to provide a pressurized airflow to the patient interface chamber 3001.

[0339] The catheter 3900 can also stabilize and position the sealing structure 3100 on the patient's face. Therefore, the catheter 3900 can function similarly to a tether for positioning and stabilizing the structure 3300. Thus, the mechanical connection between the catheter 3900 and the catheter connector 3800 is sufficient to allow tension in the catheter 3900 to be transmitted through the catheter connector 3800 to the sealing structure 3100.

[0340] Catheter 3900 may include features of a similar catheter disclosed in International Application Publication No. WO 2017 / 124155 A1, the entire contents of which are incorporated herein by reference. For example, catheter 3900 of the present technology may be included in this document. Figures 3A to 3L Features of the headband tube 3350 as described in Chinese and related written descriptions.

[0341] The catheter 3900 may also be provided with a sleeve 3901 to cushion the patient's face against the catheter 3900. The sleeve 3901 is removable. The sleeve 3901 may be made of a breathable material.

[0342] The conduit 3900 may also include a tether connector 3902 to facilitate connection with the tether of the positioning and stabilizing structure 3300.

[0343] 5.3.9 Conduit Connector

[0344] According to an example of the present technology, the patient interface 3000 may include a catheter connector 3800 to connect a catheter 3900 to an inflation chamber 3200 to provide a pressurized airflow to the patient interface chamber 3001. Each catheter connector 3800 may have its own catheter connector housing 3801. The catheter connector 3800 may provide other functions, as described below, such as ventilation of the patient interface chamber 3001, connection to a positioning and stabilization structure 3300, and prevention of asphyxiation by including an anti-asphyxiation valve 3850.

[0345] Figures 7 to 18 Several views of the catheter connector 3800 of the patient interface 3000 according to an example of the present technology are shown. Figures 25 to 31 Several views of an isolated catheter connector 3800 according to an example of this technology are shown. Figures 32 to 36Several views of a complete patient interface 3000 with a catheter 3900 and a positioning and stabilization structure 3300 connected to a catheter connector 3800, according to an example of the present technology, are shown.

[0346] exist Figures 7 to 18 In the diagram, a catheter connector 3800 is shown attached to an air chamber 3200 at an air chamber orifice 3201. It can be seen that there is one catheter connector 3800 on each side of the patient interface 3000, and each catheter connector 3800 is connected to the air chamber orifice 3201 on each corresponding side of the patient interface 3000. Each catheter connector 3800 may include a catheter connector attachment structure 3807 to connect each catheter connector 3800 to the corresponding air chamber orifice 3201 at a connection edge 3202. This connection may be mechanical, such as a snap-fit ​​or friction fit. The connection may also be removable. The materials of the catheter connector 3800 and the air chamber 3200 may be chosen separately to facilitate desired connection features. For example, the materials of the catheter connector 3800 and the air chamber 3200 may each be relatively rigid to allow auditory and / or tactile feedback associated with a snap-fit ​​fit. The materials of the catheter connector 3800 and the air chamber 3200 may be different in at least one aspect, or they may be the same. The catheter connector 3800 can also be permanently attached to the inflation chamber 3200 at the inflation chamber orifice 3201. For example, the catheter connector 3800 can be ultrasonically welded to the inflation chamber 3200 at the inflation chamber orifice 3201. The connection between the catheter connector 3800 and the inflation chamber 3200 (whether removable or permanent) can also be designed to be strong enough that tension from the catheter 3900 can be transferred to the inflation chamber 3200 without damaging the connection, because, as explained above, the catheter connector 3800 can facilitate the positioning and stability of the sealing structure 3100 on the patient's head.

[0347] The catheter connector 3800 can also be attached to the side of the inflation chamber 3200 to improve the aesthetics of the patient interface 3000. As explained above, the inflation chamber 3200 can be made of a transparent or translucent material, which allows the patient's facial features to be visible. By laterally positioning the catheter connector 3800 on the inflation chamber, for example, as shown in the illustrated example, more of the patient's face is visible, and this arrangement improves the aesthetics of the patient interface 3000. This contrasts with an alternative design in which the bend and air circuit can be connected to the center of the inflation chamber 3200, thereby obscuring the patient's view of their face.

[0348] The catheter connector 3800 and the inflation chamber orifice 3201 can also be arranged such that at least a portion of the catheter connector housing 3801 extends into the patient interface chamber 3001. This arrangement reduces unused space within the patient interface chamber 3001 by utilizing the volume within the patient interface chamber 3001 with the catheter connector 3800. Therefore, a smaller overall volume of the catheter connector 3800 extends outward from the patient interface 3000. This can be advantageous because it reduces excess structure that could easily become trapped in bedding, and it provides the patient with a smoother aesthetic that may be more visually appealing.

[0349] The conduit connector 3800 may also each include a conduit connection end 3802 connected to a corresponding 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 orifice 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, for example, an undercut structure to facilitate a removable, snap-fit ​​connection with the corresponding conduit 3900, and each conduit 3900 may include a relatively rigid structure at the end connected to the conduit connector 3800 to facilitate such a connection. The conduit connector 3800 may also be connected to the conduit 3900 by a friction fit. Furthermore, as explained above, catheter 3900 can provide positioning and stabilization functions to position the sealing structure in a therapeutically effective sealing position on the patient's face. Therefore, the connection between catheter 3900 and catheter connector 3800 at catheter connection end 3802 can be strong enough to allow tension from catheter 3900 to be transmitted to catheter connector 3800 without disrupting the connection between catheter 3900 and catheter connector 3800 at catheter connection end 3802.

[0350] The catheter connector 3800 can also provide ventilation functionality for the patient interface 3000. The catheter connector housing 3801 may include a catheter connector vent inlet 3832, which is pneumatically connected to the patient interface chamber 3001 when the patient interface 3000 is assembled. The catheter connector housing 3801 may also include at least one catheter connector vent 3831. As can be seen from the depicted examples, each catheter connector housing 3801 includes multiple catheter connector vents 3831. The catheter connector housing 3801 may also include a baffle 3805 to prevent air entering the patient interface chamber 3001 via the catheter connector outlet orifice 3804 from directly escaping through the catheter connector vents 3831. This ensures adequate mixing of newly introduced air with the air already present in the patient interface chamber 3001, which enhances carbon dioxide flushing and increases the amount of fresh air provided to the patient for breathing. The catheter connector housing 3801 may also include at least one catheter connector vent spacer 3833. Figures 25 to 31 Multiple duct connector vent spacers 3833 are shown in these examples to provide a pathway for exhaled air to escape from the duct connector 3800 through the duct connector vent outlet 3830 to the atmosphere. The duct connector vent spacers 3833 may be distributed around a portion of the periphery of the duct connector housing 3801. The duct connector vent spacers 3833 may maintain a gap between a portion of the duct connector housing 3801 and the inflation chamber 3200 for the duct connector vent outlet 3830.

[0351] The catheter connector housing 3801 may also include a diffuser cavity 3871, which may contain a diffusion material (not shown). The diffusion material may be enclosed within the diffuser cavity 3871 by a diffuser cap 3870. The diffuser cap 3870 may be permanently attached to the catheter connector housing 3801, preventing the patient from replacing the diffusion material in the event of contamination leading to occlusion. In this example, the diffuser cap 3870 may be ultrasonically welded to the catheter connector housing 3801. Alternatively, the diffuser cap 3870 may be removably attached to the catheter connector housing 3801, for example, via a snap-fit ​​or friction fit, which would allow the patient to replace the diffusion material.

[0352] like Figures 32 to 36As shown, the catheter connector 3800 can also provide a connection to a tether of the positioning and stabilizing structure 3300. The lower tether can be connected to the catheter connector 3800 via a clip 3301. The clip 3301 and the catheter connector 3800 may include magnets of opposite polarities to facilitate connection. The connection between the tether of the positioning and stabilizing structure 3300 and the catheter connector 3800 can be releasable. Tension from the lower tether of the positioning and stabilizing structure 3300 can cause the lower portion of the sealing forming structure 3100 to seal against the patient's face (e.g., around the mouth). Although in Figures 25 to 31 The structure for connecting to the clip 3301 is not shown, but can be used on the diffuser cover 3870. Alternatively, the structure for connecting to the clip 3301 can be formed directly on the conduit connector housing 3801.

[0353] Figures 39 to 66 Another example of this technology is described, which includes similar... Figures 7 to 36 The characteristics of the instances described in the text. Figures 39 to 66 Examples in the text also include those related to... Figures 7 to 36 The examples depicted in the text have different characteristics.

[0354] As in Figures 39 to 66 As can be seen in the example depicted, the inflation chamber 3200 includes a plurality of inflation chamber vents 3401 to allow gases (including exhaled carbon dioxide) to be released from the patient interface chamber 3001 into the atmosphere. Therefore, the catheter connector 3800 of this example does not include any ventilation structures present in the aforementioned examples (i.e., catheter connector vent outlet 3830, catheter connector vent 3831, catheter connector vent inlet 3832, etc.), because the size and shape of the inflation chamber vents 3401 can be configured and provided in a sufficiently large number to allow adequate flushing of carbon dioxide.

[0355] In an alternative 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, etc., while the inflation chamber 3200 is also provided with multiple inflation chamber vent holes 3401. This arrangement may be advantageous because it can provide additional and / or better diffusion ventilation.

[0356] Although the pipe connector 3800 in this example does not include any venting structure (i.e., the vent outlet 3830 of the pipe connector), an anti-suffocation valve assembly 3850 is still provided for each pipe connector 3800 for safety reasons. Figure 46 and 47 The movement of the anti-suffocation valve disc 3851 between the open and closed positions is shown, similar to the example above.

[0357] exist Figures 39 to 66In this example, the inflation chamber 3200 may not have a sealing structure on the inflation chamber orifice 3201. In this example, the seal between the conduit connector 3800 and the inflation chamber 3200 can be achieved by a conduit connector outlet seal 3861, which engages around the outer periphery of the conduit connector outlet 3808. The conduit connector outlet seal 3861 may be made of an elastomeric material (e.g., polysilicone) that deforms upon contact with the connection edge 3202 surrounding each inflation chamber orifice 3201. The conduit connector outlet seal 3861 may be overmolded onto the conduit connector outlet 3808. When the conduit connector 3800 is attached to the corresponding inflation chamber orifice 3201, the conduit connector outlet seal 3861 deforms against the connection edge 3202 and ensures a seal between them. In this example, the conduit connector outlet seal 3861 may extend around the entire conduit connector outlet 3808, or the conduit connector outlet seal 3861 may be provided only at one or more selected portions surrounding the conduit connector outlet 3808.

[0358] Alternatively, it is conceivable that the conduit connector outlet seal 3861 is disposed at the connection edge 3202 of each inflation chamber orifice 3201 to abut against the deformation of the conduit connector outlet 3808 of each conduit connector 3800. In this example, the conduit connector outlet seal 3861 may extend around the entire inflation chamber orifice 3201, or the conduit connector outlet seal 3861 may be disposed only at one or more selected portions around the inflation chamber orifice 3201.

[0359] In another alternative embodiment, a deformable sealing element may not be present between the conduit connector 3800 and the connection edge 3202 of the corresponding inflation chamber orifice 3201. Therefore, leakage can be permitted in this alternative, or the tolerance between the conduit connector 3800 and the connection edge 3202 of the corresponding inflation chamber orifice 3201 can be so small as to allow minimal or no leakage.

[0360] exist Figures 39 to 66 In one example, the conduit connector 3800 may be configured to provide a releasable connection to the inflation chamber 3200 at a corresponding inflation chamber orifice 3201. The conduit connector 3800 may be constructed of a relatively rigid plastic material (e.g., polycarbonate) to facilitate the connection described below.

[0361] A slot 3203 and a locking pin 3204 may be formed on the inflation chamber 3200 at each inflation chamber orifice 3201 to engage with the corresponding structure of the catheter connector 3800. This engagement process can be initiated by engaging a first tab 3890 with the slot 3203 from the front side of the inflation chamber 3200 (i.e., the side facing away from the patient in use). The first tab 3890 may be relatively rigid, and its engagement with the slot 3203 can act as a fulcrum, allowing the catheter connector 3800 to subsequently rotate about the slot 3203 to complete the engagement process. This engagement process can be accomplished by a second tab 3891 having a snap 3892 that engages with the locking pin 3204 of the inflation chamber 3204. When the catheter connector 3800 is rotated to engage with the inflation chamber 3200 in the corresponding inflation chamber orifice 3201, the catheter connector outlet seal 3861 may engage with the corresponding connection edge 3202 to establish a pneumatic seal. Additionally, the catheter connector outlet 3808 may extend at least partially through the corresponding inflation chamber orifice 3201, allowing gas to travel between the patient interface chamber 3001 and the catheter connector 3800. The second tab 3891 may be flexible, enabling a snap-fit ​​connection when the latch 3892 and the locking pin 3204 engage. This may be beneficial to the patient, as the snap-fit ​​connection provides tactile and audible feedback on the establishment of the connection. A gap 3893 on either side of the second tab 3891 and between the catheter connector outlets 3808 allows the second tab 3891 to be cantilevered, facilitating easier deformation during engagement and disengagement.

[0362] The disengagement process occurs in reverse order. First, the snap 3892 disengages from the corresponding pin 3204 by rotating the conduit connector 3800 in a forward direction away from the inflation chamber 3200. Since the second tab 3891 is flexible, once sufficient force is applied, the second tab will deflect and allow the snap 3892 to disengage from the pin 3204. The conduit connector 3800 then rotates further, causing the first tab 3890 to disengage from the slot 3203. During the disengagement process, the conduit connector outlet seal 3861 also disengages from the corresponding connection edge 3202, and the conduit connector outlet 3808 exits the corresponding inflation chamber orifice 3201.

[0363] When engaged, the conduit connector 3800 can extend in a forward direction relative to the inflation chamber 3200, allowing the conduit 3900 to be laterally guided away from the inflation chamber 3200. By positioning the conduit 3900 in front of the inflation chamber 3200, the conduit 3900 can remain engaged and undamaged when lateral forces pull the conduit 3900 away from the inflation chamber 3200, while also reducing the force required to disengage the conduit connector 3800 (and therefore the conduit 3900) from the inflation chamber 3200. Thus, as will be discussed further below, the conduit 3900 can engage with the conduit connector 3800 with sufficient strength to resist disengagement in the lateral direction, while also allowing the conduit connector 3800 to be relatively easily removed from the inflation chamber 3200 by rotating away from the inflation chamber orifice 3201, as described above. This arrangement may be advantageous in typical use cases because lateral forces are likely to be common during use (i.e., during sleep), and it is advantageous to ensure that the patient interface 3000 can withstand these forces without damaging the connection between the catheter 3900 and the inflation chamber 3200, thus not interrupting the gas flow. However, the forces that cause the aforementioned disengagement process are less common during sleep. Therefore, the first tab 3890 and the second tab 3891 can be designed to engage and disengage with the slot 3203 and the locking pin 3204 in their respective directions with relatively low force, which in turn allows the patient to easily engage and disengage the catheter connector 3800. In this example, the disengagement force can be as low as 8 to 12 Newtons.

[0364] In addition, the force required to disengage the conduit connector 3800 can be low enough that the conduit connector 3800 can be disengaged by applying a forward force to the flange 3885, which is configured for positioning and stabilizing the structure 3300.

[0365] The conduit connector 3800 may further include a flange 3885 for attaching the lower tether 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 integrally molded with the conduit connector 3800. The flange 3885 may include a flange opening 3887 and a recess 3886 to receive a tab connector 3884 of the lower tether tab 3880. To attach the lower tether tab 3880 to the flange 3885, the tab connector 3884 passes through the flange opening 3887 and engages in the recess 3886. The lower tether tab 3880 may include a clip receiver 3881, which may accommodate a magnet to provide a releasable connection to a corresponding magnet in the clip 3301. The clip receiver 3881 can also engage with the overhang 3307 of the clip 3301 to ensure that the clip 3301 remains engaged with the lower tie tab 3880. Therefore, the attraction between the magnets of the clip 3301 and the clip receiver 3881 provides a positioning function, while the engagement of the overhang 3307 with 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 is releasable by applying a force sufficient to overcome the attraction between the two magnets. The lower tie tab 3880 may also include a notch 3882.

[0366] The catheter 3900 can be permanently or removably attached to the catheter connector 3800 at the catheter connector end 3802. Figure 63 An example of a permanent connection is depicted, wherein an intermediate conduit connector inlet seal 3860 (e.g., made of silicone) is molded around a conduit connector end 3802. A conduit 3900 (which may also be made of silicone) is molded onto the intermediate conduit connector inlet seal 3860.

[0367] 5.3.10 Anti-asphyxiation valve

[0368] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve. For example... Figure 7-18 As best shown in Figures 25-31, each catheter connector 3800 may include an anti-asphyxiation valve assembly 3850. Therefore, the patient interface 3000 may include two anti-asphyxiation valve assemblies 3850. Each anti-asphyxiation valve assembly 3850 may operate independently of the other (i.e., in response to an interruption of pressurized airflow). For example, if the patient is sleeping on their side when pressurized airflow is interrupted, and one of the anti-asphyxiation valve assemblies 3850 is blocked by a pillow, the other anti-asphyxiation valve assembly 3850 may be used to prevent the patient from suffocating.

[0369] The anti-choke valve assembly 3850 may include an anti-choke valve disc 3851 that covers the anti-choke valve orifice 3852 when in the closed position. Figure 14and 29 The cross-sectional views depict the anti-asphyxiation valve 3851 in the closed position. In these views, it can be seen that the pressurized airflow entering the catheter connector 3800 is prevented by the anti-asphyxiation valve 3851 from escaping into the atmosphere through the anti-asphyxiation valve orifice 3852, and is guided into the patient interface chamber 3001 by the catheter connector outlet orifice 3804. The anti-asphyxiation valve 3851 can be configured to remain in the closed position throughout the patient's entire respiratory cycle (i.e., inspiration and expiration). Therefore, the patient receives a pressurized airflow into their airway to ensure that the patient's airway remains adequately open during inspiration and expiration. Figure 15 and 30 An anti-asphyxiation valve disc 3851 in the open position is depicted, wherein the anti-asphyxiation valve orifice 3852 is uncovered, allowing the patient to breathe from the atmosphere via the anti-asphyxiation valve orifice 3852 if the compressed air flow is interrupted. Furthermore, the anti-asphyxiation valve disc 3851 can be configured such that the open position can be a default, neutral, or undeformed position, such that the anti-asphyxiation valve disc 3851 is moved to the closed position by the force of the pressure and / or airflow only when a pressurized air flow (at least a minimum flow rate and / or pressure) is applied. Additionally, the anti-asphyxiation valve orifice 3852 can be sized sufficiently such that if one of the anti-asphyxiation valve assemblies 3850 is blocked and breathing is prohibited, the patient can breathe adequately through the unblocked anti-asphyxiation valve assembly 3850. Furthermore, the anti-asphyxiation valve disc 3851 can be sized such that the anti-asphyxiation valve orifice 3852 is completely closed when in the closed position. Alternatively, the anti-suffocation valve disc 3851 may include orifices that, when in the closed position, allow air to pass through to the atmosphere, for example, for ventilation.

[0370] The anti-suffocation valve 3851 can be connected to the conduit connector housing 3801 via an anti-suffocation valve connector 3854 extending into an anti-suffocation valve connector hole 3853. The anti-suffocation valve 3851 can be permanently attached to the conduit connector housing 3801 at the anti-suffocation valve connector hole 3853 by overmolding it onto the conduit connector housing 3801. The anti-suffocation valve 3851 can be made of a flexible, resilient material that allows it to be deflected from an open position to a closed position by pressure and / or airflow.

[0371] The anti-asphyxiation valve assembly 3850 may also include an anti-asphyxiation valve port separator 3855 spanning the anti-asphyxiation valve port 3852. The anti-asphyxiation valve port separator 3855 prevents the anti-asphyxiation valve disc 3851 from being pushed out of the anti-asphyxiation valve port 3852 due to pressure within the patient interface chamber 3001.

[0372] Port 5.3.11

[0373] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In another embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0374] 5.4RPT device

[0375] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to perform all or part of one or more algorithms 4300, such as any methods described herein. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, for example, for treating one or more respiratory conditions described elsewhere in this document.

[0376] In one embodiment, the RPT device 4000 is constructed and arranged to deliver an airflow 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.

[0377] The RPT device may have an outer housing 4010, which is composed of two parts, an upper part 4012 and a lower part 4014. Furthermore, the outer 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.

[0378] The pneumatic path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 capable of supplying positive pressure air (e.g., a blower 4142), an outlet silencer 4124, and one or more converters 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0379] One or more air path items may be located within a removable, separate structure referred to as pneumatic block 4020. Pneumatic block 4020 may be located within an outer housing 4010. In one form, pneumatic block 4020 is supported by or formed as part of chassis 4016.

[0380] The RPT device 4000 may include 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 converter 4270, a data communication interface 4280, and one or more output devices 4290. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative embodiment, the RPT device 4000 may include more than one PCBA 4202.

[0381] 5.4.1 Mechanical and pneumatic components of the RPT device

[0382] The RPT device may include one or more of the following components in an overall unit. In an alternative form, one or more of the following components may be positioned as separate units.

[0383] 5.4.1.1 Air Filter

[0384] One form of RPT device according to the present technology may include an air filter 4110, or a plurality of air filters 4110.

[0385] In one configuration, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0386] In one configuration, an outlet air filter 4114, such as an antibacterial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0387] 5.4.1.2 Muffler

[0388] One form of RPT device according to the present technology may include a muffler 4120, or a plurality of mufflers 4120.

[0389] In one embodiment of this technology, the inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0390] In one embodiment of this technology, the outlet silencer 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0391] 5.4.1.3 Pressure Generator

[0392] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply 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, such as a volute. The blower may be capable of supplying air at a positive pressure of about 4 cmH2O to about 20 cmH2O, or in other forms at a positive pressure of up to about 30 cmH2O, for example at a rate of up to about 120 liters per minute. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013 / 020167.

[0393] The pressure generator 4140 is controlled by the treatment device controller 4240.

[0394] 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.

[0395] 5.4.1.4 Converter

[0396] The transducer can be located inside or outside the RPT device. An external transducer can be located on, for example, an air circuit (e.g., a patient interface) or formed part of it. An external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits data to or to the RPT device.

[0397] In one form of this technology, one or more converters 4270 may be located upstream and / or downstream of pressure generator 4140. One or more converters 4270 may be configured and arranged to generate signals representing properties of airflow at that point in the pneumatic path, such as flow rate, pressure, or temperature.

[0398] In one form of this technology, one or more converters 4270 may be located proximal to the patient interface 3000.

[0399] In one configuration, the signal from converter 4270 can be filtered, for example by low-pass filtering, high-pass filtering, or band-pass filtering.

[0400] 5.4.1.4.1 Flow Sensor

[0401] The flow sensor 4274 according to this technology can be based on a differential pressure converter, such as the SDP600 series differential pressure converter from SENSIRION.

[0402] In one configuration, a signal representing flow rate from flow sensor 4274 is received by central controller 4230.

[0403] 5.4.1.4.2 Pressure Sensor

[0404] The pressure sensor 4272 according to this technology is positioned in fluid communication with the pneumatic path. A suitable example of a pressure sensor is the converter from the HONEYWELL ASDX series. An alternative suitable pressure sensor is the converter from the GENERALELECTRIC NPA series.

[0405] In one configuration, the signal from pressure sensor 4272 is received by central controller 4230.

[0406] 5.4.1.4.3 Motor speed converter

[0407] In one form of this technology, a motor speed converter 4276 is used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed converter 4276 can be provided to the treatment device controller 4240. The motor speed converter 4276 can be, for example, a speed sensor, such as a Hall effect sensor.

[0408] 5.4.1.5 Anti-overflow valve

[0409] In one embodiment of this technology, an anti-backflow valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000, for example, to the motor 4144.

[0410] 5.4.2 Electrical components of the RPT device

[0411] 5.4.2.1 Power Supply

[0412] The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.

[0413] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of the invention, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.

[0414] 5.4.2.2 Input Device

[0415] In one form of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow personnel to interact with the device. The buttons, switches, or dials can be physical devices or software devices accessed via a touchscreen. In one form, the buttons, switches, or dials can be physically connected to an external housing 4010, or in another form, they can wirelessly communicate with a receiver electrically connected to a central controller 4230.

[0416] In one form, the input device 4220 may be configured and arranged to allow a person to select values ​​and / or menu options.

[0417] 5.4.2.3 Central Controller

[0418] In one form of this technology, the central controller 4230 is one or more processors adapted to control the RPT device 4000.

[0419] Suitable processors may include x86 Intel processors, and processors based on those from ARM Holdings. The processor can be a processor such as the STM32 series microcontrollers from ST Microelectronics. In some alternative forms of this technology, a 32-bit RISC CPU, such as the STR9 series microcontrollers from ST Microelectronics, or a 16-bit RISC CPU, such as a processor from the MSP430 series microcontrollers manufactured by Texas Instruments, can also be used.

[0420] In one form of this technology, the central controller 4230 is a dedicated electronic circuit.

[0421] In one form, the central controller 4230 is an application-specific integrated circuit (ASIC). In another form, the central controller 4230 includes discrete electronic components.

[0422] The central controller 4230 can be configured to receive input signals from one or more converters 4270, one or more input devices 4220, and humidifier 5000.

[0423] The central controller 4230 can be configured to provide output signals to one or more output devices 4290, treatment device controller 4240, data communication interface 4280, and humidifier 5000.

[0424] In some forms of this technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms represented as computer programs, which are stored in a non-transitory computer-readable storage medium, such as 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 remote positioning device. For example, the remote positioning device may determine the control settings of the ventilator or detect respiratory-related events by analyzing stored data from, for example, any of the sensors described herein.

[0425] 5.4.2.4 Clock

[0426] RPT device 4000 may include a clock 4232 connected to central controller 4230.

[0427] 5.4.2.5 Treatment device controller

[0428] In one form of this technology, the treatment device controller 4240 is a treatment control module that forms part of an algorithm executed by the central controller 4230.

[0429] 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.

[0430] 5.4.2.6 Protection Circuit

[0431] One or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0432] 5.4.2.7 Memory

[0433] According to one embodiment of the present technology, the RPT device 4000 includes a memory 4260, such as 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.

[0434] The memory 4260 can be located on PCBA 4202. The memory 4260 can be in the form of EEPROM or NAND flash memory.

[0435] Alternatively or alternatively, the RPT device 4000 includes a removable memory 4260, such as a memory card made according to the Secure Digital (SD) standard.

[0436] In one form of this technology, memory 4260 is used as a non-transitory computer-readable storage medium storing computer program instructions, such as one or more algorithms, representing one or more methods described herein.

[0437] 5.4.2.8 Data Communication System

[0438] 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 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.

[0439] 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 a processor.

[0440] In one embodiment, the remote external communication network 4282 is the Internet. The data communication interface 4280 can connect to the Internet using wired communication (e.g., via Ethernet or fiber optic) or wireless protocols (e.g., CDMA, GSM, LTE).

[0441] In one form, the local external communication network 4284 utilizes one or more communication standards, such as Bluetooth or consumer infrared protocols.

[0442] In one form, the remote external device 4286 can be one or more computers, such as a cluster of networked computers. In another form, the remote external device 4286 can be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 can be accessed by appropriately authorized personnel (such as clinicians).

[0443] The local external device 4288 can be a personal computer, mobile phone, tablet, or remote control device.

[0444] 5.4.2.9 Includes optional display and alarm output devices.

[0445] The output device 4290 according to this technology can take the form of one or more of visual, audio, and tactile units. The visual display can be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0446] 5.4.2.9.1 Display Driver

[0447] The display driver 4292 receives characters, symbols, or images as input for display on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols, or images.

[0448] 5.4.2.9.2 Monitor

[0449] 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 eight-segment display, in which case the display driver 4292 converts each character or symbol (such as the number "0") into eight logic signals that indicate whether the eight corresponding segments will be activated to display a specific character or symbol.

[0450] 5.5 Air Circuit

[0451] According to one aspect of the technology, the air circuit 4170 is a conduit or tube that is constructed and arranged to allow airflow between two components, such as the RPT device 4000 and the patient interface 3000, during use.

[0452] Specifically, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, the circuit can have separate branches for inhalation and exhalation. In other cases, a single branch is used.

[0453] In some forms, 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 temperature of the air. The heating element may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating element may communicate with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0454] 5.5.1 Oxygen Delivery

[0455] In one form of this technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic path (e.g., upstream of pneumatic block 4020), air circuit 4170, and / or patient interface 3000.

[0456] 5.6 Humidifier

[0457] 5.6.1 Overview of Humidifiers

[0458] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 5A (As shown), to change the absolute humidity of the air or gas used to deliver to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0459] 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 forms, such as Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which may be adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.

[0460] 5.6.2 Humidifier Components

[0461] 5.6.2.1 Water Storage Tank

[0462] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to hold or retain a volume of liquid (e.g., water) for evaporation to humidify the airflow. The water reservoir 5110 may be configured to hold a predetermined maximum amount of water to provide adequate humidification for at least the duration of a respiratory therapy session, such as one night's sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 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, such as a building water supply system.

[0463] According to one aspect, the water reservoir 5110 is configured to increase the humidity of an airflow from the RPT device 4000 as an airflow passes through it. In one form, the water reservoir 5110 may be configured to cause an airflow to travel through the reservoir 5110 in a curved path while contacting a certain volume of water therein.

[0464] According to one form, the storage 5110 can, for example, be along such a path... Figure 5A and Figure 5B The lateral direction shown is removed from the humidifier 5000.

[0465] The reservoir 5110 can also be configured to prevent liquid from flowing out of it, for example, through any orifice and / or between its sub-assemblies, when the reservoir 5110 is displaced and / or rotated from its normal operating direction. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 can also be configured to prevent aerodynamic pressure loss through leakage and / or flow resistance.

[0466] 5.6.2.2 Conductive Component

[0467] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow heat to be efficiently transferred from the heating element 5240 to a volume of liquid within the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes are equally applicable. All or part of the conductive portion 5120 may be made of a thermally conductive material, such as aluminum (e.g., with a thickness of about 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity can be achieved using materials with appropriate geometries and lower thermal conductivity.

[0468] 5.6.2.3 Humidifier reservoir base

[0469] In one embodiment, the humidifier 5000 may include a humidifier reservoir base 5130 (e.g., Figure 5B As shown, it is configured to receive humidifier reservoir 5110. In some arrangements, humidifier reservoir base 5130 may include locking features, such as a locking lever 5135 configured to hold reservoir 5110 in humidifier reservoir base 5130.

[0470] 5.6.2.4 Water level indicator

[0471] The humidifier reservoir 5110 may include, for example: Figures 5A-5B The water level indicator 5150 is shown. In some forms, the water level indicator 5150 can provide one or more indications to a user (such as a patient 1000 or a caregiver) regarding the amount of water in a given volume in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include indications of a maximum predetermined volume of water, any portion thereof such as 25%, 50%, 75%, or various volumes such as 200 ml, 300 ml, or 400 ml.

[0472] 5.6.2.5 Humidifier Converter

[0473] The humidifier 5000 may include one or more humidifier converters (sensors) 5210, other than or in addition to the converter 4270 described above. For example... Figure 5CAs shown, the humidifier converter 5210 may include one or more of an air pressure sensor 5212, an air flow converter 5214, a temperature sensor 5216, or a humidity sensor 5218. The humidifier converter 5210 may generate one or more output signals that can be sent to a controller (such as a central controller 4230 and / or a humidifier controller 5250). In some forms, the humidifier converter may be located outside the humidifier 5000 (e.g., in the air circuit 4170) when sending the output signal to the controller.

[0474] 5.6.2.5.1 Pressure Transmitter

[0475] In addition to the pressure sensor 4272 provided in the RPT device 4000, the humidifier 5000 may be provided with one or more pressure transducers 5212.

[0476] 5.6.2.5.2 Flow Converter

[0477] In addition to the flow sensor 4274 provided in the RPT device 4000, the humidifier 5000 may be provided with one or more flow converters 5214.

[0478] 5.6.2.5.3 Temperature Converter

[0479] 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, such as the temperature of the heating element 5240 and / or the temperature of the airflow downstream of the humidifier outlet 5004. In some forms, the humidifier 5000 may also include a temperature sensor 5216 for detecting the ambient air temperature.

[0480] 5.6.2.5.4 Humidity Converter

[0481] In some forms, the humidifier 5000 may include one or more humidity sensors 5218 for detecting the humidity of a gas (such as ambient air). In some forms, the humidity sensor 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.

[0482] 5.6.2.6 Heating element

[0483] In some cases, the humidifier 5000 may be provided with a heating element 5240 to provide heat input to one or more of a volume of water in the humidifier reservoir 5110 and / or to an airflow. The heating element 5240 may include a heating component, such as a resistive electric heating rail. A suitable example of the heating element 5240 is a layered heating element, such as the layered heating element described in PCT Patent Application Publication No. WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0484] In some configurations, the heating element 5240 may be housed in the humidifier base 5006, where it can be primarily heated by means of, for example, Figure 5B The conduction shown provides heat to the humidifier reservoir 5110.

[0485] 5.6.2.7 Humidifier Controller

[0486] According to one arrangement of this technology, such as Figure 5C As shown, the humidifier 5000 may include a humidifier controller 5250. 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 standalone controller that can communicate with the central controller 4230.

[0487] In one configuration, the humidifier controller 5250 may receive, for example, measurements of airflow and water properties (such as temperature, humidity, pressure, and / or flow rate) in the reservoir 5110 and / or humidifier 5000 as inputs. The humidifier controller 5250 may also be configured to execute or implement humidifier algorithms and / or deliver one or more output signals.

[0488] like Figure 5C As shown, the humidifier controller 5250 may include one or more controllers, such as a central humidifier controller 5251, a heating air circuit controller 5254 configured to control the temperature of the heating air circuit 4170, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240.

[0489] 5.7 Respiratory waveform

[0490] Figure 6The diagram shows a typical respiratory waveform during human sleep. The horizontal axis represents time, and the vertical axis represents respiratory flow. Although parameter values ​​can vary, typical breathing can be approximated by the following: tidal volume Vt, 0.5 L; inspiratory time Ti, 1.6 s; peak inspiratory flow Qpeak, 0.4 L / s; expiratory time Te, 2.4 s; peak expiratory flow Qpeak, -0.5 L / s. The total duration of breathing, Ttot, is approximately 4 s. Humans typically breathe at a rate of approximately 15 breaths per minute (BPM), with a tidal volume of approximately 7.5 L / min. The typical duty cycle, the ratio of Ti to Ttot, is approximately 40%.

[0491] 5.8 Glossary

[0492] To achieve the purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0493] 5.8.1 General Rules

[0494] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0495] Environment: In some forms of this technology, the term environment may have the following meanings: (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0496] For example, the ambient humidity relative to the humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity in the room where the patient sleeps. This ambient humidity can differ from the humidity outside the room where the patient is sleeping.

[0497] In another instance, environmental stress can be stress that is directly around the body or outside the body.

[0498] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room, excluding noise generated by, for example, the RPT device or emanating from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0499] Automated Positive Airway Pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjustable between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SBD event.

[0500] Continuous positive airway pressure (CPAP) therapy: In this therapy, the treatment pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In some forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing when no indication of partial upper airway obstruction is detected.

[0501] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be to a scalar quantity, that is, a quantity that only has a value. In other cases, the reference to flow rate will be to a vector quantity, that is, a quantity that has both a value and a direction. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated as 'flow' or 'airflow'.

[0502] In the context of patient breathing, flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Total flow rate Qt is the flow rate of air leaving the RPT device. Tidal flow rate Qv is the flow rate of air leaving the ventilator to allow flushing of exhaled air. Leakage flow rate Ql is the leakage flow rate from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0503] Humidifier: The term humidifier will be understood as a humidification device that is constructed and arranged, or configured, with a physical structure that provides a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve a patient’s medical respiratory symptoms.

[0504] Leakage: The term "leakage" will be understood as undesirable airflow. In one instance, leakage can occur due to an incomplete seal between the mask and the patient's face. In another instance, leakage can occur in the bend of the swivel tube leading to the surrounding environment.

[0505] Noise, conducted (acoustic): In this document, conducted noise refers to noise delivered to the patient through a pneumatic path (such as the air circuit and the patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0506] Noise, radiated (acoustic): Radiated noise in this document refers to noise delivered to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / sound pressure level of the object under discussion according to ISO 3744.

[0507] Noise, Vent (Acoustic): Vent noise in this document refers to the noise generated by the airflow passing through any vent (such as a vent in a patient interface).

[0508] Patient: A person, whether or not they have a respiratory illness.

[0509] Pressure: The force per unit area. Pressure can be expressed in a range of units (including cmH2O, gf / cm²). 2 And (hectopascals) are used for measurement. 1 cmH2O equals 1 g-f / cm 2 It is approximately 0.98 hectopascals. In this specification, unless otherwise stated, pressure is given in cmH2O.

[0510] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained at the current moment through the mask pressure Pm.

[0511] Respiratory pressure therapy (RPT): Applying an air supply to the airway inlet at a therapeutic pressure that is typically positive relative to the atmosphere.

[0512] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0513] 5.8.1.1 Materials

[0514] Silicone or silicone elastomer: A synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the product range sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45, as measured using ASTM D2240.

[0515] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0516] 5.8.1.2 Mechanical Properties

[0517] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during release.

[0518] Resilient: When decelerated, it releases virtually all of its energy. This includes, for example, certain silicones and thermoplastic elastomers.

[0519] Hardness: The ability of a material to resist deformation (e.g., described by Young's modulus, or by an indentation hardness scale measured at a standardized sample size).

[0520] 'Soft' materials may include silicone or thermoplastic elastomers (TPEs) and may be easily deformed, for example, under finger pressure.

[0521] 'Hard' materials can include polycarbonate, polypropylene, steel or aluminum, and can be, for example, not easily deformed under finger pressure.

[0522] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. A structure or component can provide different resistances in different directions.

[0523] Soft structures or components: Structures or components that will change shape (e.g., bend) within a relatively short period of time (e.g., 1 second) when made to support their own weight.

[0524] Rigid structures or components: Structures or components that do not substantially change shape when subjected to loads typically encountered in use. An example of such use could be setting up and maintaining a patient interface in a sealed relationship with the inlet of the patient's airway, for example, under a load of approximately 20 to 30 cmH2O.

[0525] As an example, an I-beam can have different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, a structure or component can be flexible in the first direction and rigid in the second direction.

[0526] 5.8.2 Respiratory cycle

[0527] Apnea: According to some definitions, apnea is considered to occur when the flow rate drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway prevents airflow even with patient effort. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is open. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0528] Respiratory rate: The patient’s spontaneous respiratory rate, usually measured in breaths per minute.

[0529] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0530] Effort (breathing): The effort made by a person who is spontaneously trying to breathe.

[0531] The expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0532] Flow limitation: Flow limitation is considered an event state in a patient's breathing where increased effort does not result in a corresponding increase in flow. Flow limitation occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow limitation. Flow limitation occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow limitation.

[0533] Types of flow-limited inhalation waveforms:

[0534] (i) Flat: It has an upward movement, followed by a relatively flat section, and then a downward movement.

[0535] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat section between the two peaks.

[0536] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.

[0537] (iv) Inverted chair shape: with a relatively flat section followed by a single local peak at the trailing edge.

[0538] Hypoventilation: By some definitions, hypoventilation is considered a decrease in flow rate, but not a cessation of flow. In one form, hypoventilation can be considered to have occurred when the flow rate drops below a threshold rate and persists for a period of time. Central hypoventilation is considered to have occurred when hypoventilation is detected due to a decrease in respiratory effort. In one form in adults, any of the following can be considered hypoventilation:

[0539] (i) The patient’s respiratory rate decreases by 30% for at least 10 seconds plus a related 4% desaturation; or

[0540] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% desaturation or arousal.

[0541] Hyperventilation: Increased airflow to above normal levels.

[0542] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0543] Airway openness: The degree to which the airway is open, or the extent to which the airway is open. An open airway is an open airway. Airway openness can be quantified, for example, a value (1) for open and a value of zero (0) for closed (obstructed).

[0544] Positive end-expiratory pressure (PEEP): Pressure above atmospheric pressure present in the lungs at the end of expiration.

[0545] Peak flow (Qpeak): The maximum flow rate during the expiratory portion of the respiratory flow waveform.

[0546] Respiratory flow, patient air flow, and respiratory air flow (Qr): These terms can be understood as the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0547] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, inspiratory volume Vi (the volume of air inhaled) equals expiratory volume Ve (the volume of air exhaled), therefore a single tidal volume Vt can be defined as equal to any one of these volumes. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, such as an average.

[0548] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0549] (Exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0550] (Total) Time (Ttot): The total duration between the start of an inspiratory portion of the respiratory flow waveform and the start of a subsequent inspiratory portion of the respiratory flow waveform.

[0551] Typical recent ventilation: The recent ventilation values ​​(Vent) tend to cluster around their respective values ​​within a predetermined time range, which is a measure of the central tendency of recent ventilation values.

[0552] Upper airway obstruction (UAO): This includes both partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or even decreases as the pressure differential in the upper airway increases (Starling resistance behavior).

[0553] Ventilation: A measurement of the flow rate of gases exchanged by a patient's respiratory system. A measurement of ventilation can include one or both of inspiratory and expiratory flow rates (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.

[0554] 5.8.3 Ventilation

[0555] Adaptive Servo Ventilator (ASV): A servo ventilator with a variable rather than a fixed target ventilation. The variable target ventilation can be determined from some characteristics of the patient, such as the patient's breathing characteristics.

[0556] Standby rate: A parameter of the ventilator that determines the minimum respiratory rate (usually measured in breaths per minute) that the ventilator will deliver to the patient if not triggered by spontaneous breathing effort.

[0557] Cyclic: Termination of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, the ventilator is considered to be cyclic at the end of the inspiratory portion of the respiratory cycle, at which point the delivery of breaths ceases.

[0558] Positive expiratory airway pressure (EPAP): The base pressure to which the ventilator will attempt to achieve the desired mask pressure at a given time, by adding pressure changes within the respiratory tract.

[0559] End-expiratory pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory phase. If the pressure waveform template (() is zero at the end of expiration, i.e., when (() = 1, (() = 0), then EEP equals EPAP.

[0560] Positive inspiratory airway pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory phase of breathing.

[0561] Pressure support: A numerical measure of the pressure increase during inspiratory breathing that exceeds the pressure during expiratory breathing, and typically refers to the pressure difference between the maximum inspiratory pressure and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference between the ventilator's target and the actual pressure achieved.

[0562] Servo ventilator: A ventilator that measures a patient's ventilation volume, has a target ventilation volume, and adjusts the level of pressure support to enable the patient to achieve the target ventilation volume.

[0563] Spontaneous / Timed (S / T): A mode of operation for a ventilator or other device that attempts to detect the initiation of spontaneous breathing in a patient. However, if the device fails to detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.

[0564] Oscillation: A term equivalent to pressure support.

[0565] Triggered: When a ventilator delivers breathing air to a patient who is breathing spontaneously, it is believed to be triggered by the patient's effort at the beginning of the breathing portion of the respiratory cycle.

[0566] 5.8.4 Anatomical Structure

[0567] 5.8.4.1 Facial Anatomy

[0568] Alar: The outer wall or "wing" of each nostril (plural: alar)

[0569] Alar tip: the outermost point on the ala of the nose.

[0570] Nasal wing curve (or nasal apex) point: the last point on the baseline of each nasal wing curve, found in the crease formed by the junction of the nasal wing and the cheek.

[0571] Auricle: The entire visible external part of the ear.

[0572] (Nose) Skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0573] (Nasal) Cartilage: The nasal cartilage includes the septal cartilage, lateral cartilage, major cartilage, and minor cartilage.

[0574] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0575] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt horizontal plane (the two lines intersect at the lower point of the nasal septum).

[0576] Frankfurt Plane: A line extending from the lowest point of the orbital rim to the left tragus point. The tragus point is the deepest point in the notch above the tragus of the auricle.

[0577] The glabella: Located on the soft tissue, it is the most prominent point in the sagittal plane at the center of the forehead.

[0578] Lateral nasal cartilage: a roughly triangular cartilaginous plate. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0579] Greater alar cartilage: A cartilaginous plate located beneath the lateral nasal cartilages. It curves around the front of the nostrils. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four smaller cartilages.

[0580] Nostrils (or nasal eyes): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostril (nare) is nasal nasal (naris). The nostrils are separated by the nasal septum.

[0581] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0582] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0583] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0584] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0585] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0586] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0587] Prechin point: Located on the soft tissue, at the midpoint of the anterior part of the chin.

[0588] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0589] The sagittal plane is a vertical plane that runs from the front (anterior) to the back (posterior). The median sagittal plane is the sagittal plane that divides the body into the right and left halves.

[0590] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0591] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0592] Posterosuperior lateral segment: The point at the lower edge of the base of the nasal ala, where the base of the nasal ala connects with the skin of the upper (superior) lip.

[0593] The subnasal point is located on the soft tissue at the junction of the columella and the upper lip in the midsagittal plane.

[0594] Mandibular alveolar point: The point of maximum concavity located on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue anterior mental point.

[0595] 5.8.4.2 Anatomical Structure of the Skull

[0596] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0597] Mandible: The mandible forms the lower jaw. Mental protuberance is the bony protuberance of the mandible that forms the chin.

[0598] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw and below the eye socket. The frontal process of the maxilla protrudes upward from the side of the nose and forms part of the lateral boundary.

[0599] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary among individuals; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0600] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the upper part of the bridge of the nose.

[0601] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval foramen (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0602] The eye socket is the bony cavity in the skull that houses the eyeball.

[0603] Parietal bone: The parietal bone is the top and sides of the skull that, when joined together, form the top of the skull.

[0604] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0605] Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the protruding parts of the cheeks.

[0606] 5.8.4.3 Anatomical Structure of the Respiratory System

[0607] Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0608] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0609] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0610] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located in the middle of the face above and behind the nose. It is divided into two parts by vertical fins called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular "concha"). The front of the nasal cavity is the nasal part, while the back connects to the nasopharynx via the internal nasal openings.

[0611] Pharynx: The part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three parts: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0612] 5.8.5 Patient Interface

[0613] Anti-asphyxia valve (AAV): A component or sub-assembly of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0614] Bend: A bend is an example of a structure in which the axis of airflow passing through it changes direction by an angle. In one form, this angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. A bend can have an approximately circular cross-section. In another form, a bend can have an elliptical or rectangular cross-section. In some forms, the bend can rotate relative to the mating component, for example, approximately 360 degrees. In some forms, the bend can be removed from the mating component, for example, by snap-fit ​​connection. In some forms, the bend can be assembled to the mating component during manufacturing by disposable snap-fit, but cannot be removed by the patient.

[0615] Frame: The frame is understood to refer to the mask structure that bears the tensile load between two or more connection points with the head strap. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0616] Headband: A headband will be understood as a form of positioning and stabilizing structure designed for use on the head. For example, a headband may include an assembly of one or more supports, straps, and reinforcements configured to position and hold the patient interface on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, and resilient materials, such as laminated composites of foam and fabric.

[0617] Membrane: A membrane will be understood to mean a typically thin element that preferably has essentially no resistance to bending but has resistance to tension.

[0618] Inflation chamber: The mask inflation chamber will be understood as part of a patient interface having walls that at least partially surround a volumetric space, which, during use, contains air pressurized therein to above atmospheric pressure. A housing may form part of the walls of the mask inflation chamber.

[0619] Seal: can be in the noun form (“seal”), which refers to a structure, or in the verb form (“seal”), which refers to an effect. Two elements can be constructed and / or arranged to 'seal' or to achieve 'seal' between them, without requiring a separate 'seal' element itself.

[0620] Shell: A shell will be understood to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0621] Reinforcing member: A reinforcing member will be understood as a structural component designed to improve the bending resistance of another component in at least one direction.

[0622] Support: A support will be understood as a structural component designed to improve the compressibility of another component in at least one direction.

[0623] Rotary shaft (noun): A sub-assembly of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotary shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the rotary shaft may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assembly of the component preferably comprises a pair of mating cylindrical ducts. During use, there may be little or no airflow leakage from the rotary shaft.

[0624] Lacing (noun): A structure designed to resist tension.

[0625] Ventilation port (noun): A structure that allows airflow from inside a mask or cannula to ambient air for clinically effective flushing of exhaled gases. For example, clinically effective flushing may include a flow rate of approximately 10 liters / minute to approximately 100 liters / minute, depending on the mask design and treatment pressure.

[0626] 5.8.6 Shape of the structure

[0627] Products according to this technology may include one or more three-dimensional mechanical structures, such as mask pads or impellers. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, the seal-forming structure may include a surface that contacts the face (e.g., the exterior) and separate surfaces that do not contact the face (e.g., the underside or interior). In yet another example, the structure may include a first surface and a second surface.

[0628] To aid in describing the shape of three-dimensional structures and surfaces, first consider the cross-section of the surface through the structure at point p. See also Figures 3B to 3F They show an example of a cross-section at point p on the surface and the resulting planar curve. Figures 3B to 3F The outward normal vector at point p is also shown. The outward normal vector at p points away from the surface. In some instances, the surface is described from the perspective of an imaginary figure standing upright on it.

[0629] 5.8.6.1 Curvature in one dimension

[0630] The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and a magnitude (e.g., 1 / radius of the circle that touches the curve only at p).

[0631] Positive curvature: If the curve turns outwards towards the normal at point p, then the curvature at that point is positive (if the figures were imaginary leaving point p, they would have to walk uphill). See also Figure 3B (and Figure 3C Compared to a relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to a relatively small positive curvature). Such curves are often referred to as concave.

[0632] Zero curvature: If the curve is a straight line at point p, then the curvature will be zero (if the imaginary figures left point p, they could walk horizontally, neither up nor down). See also Figure 3D .

[0633] Negative curvature: If the curve turns away from the outward normal at point p, the curvature in that direction at that point will be negative (if the imaginary figures leave point p, they must go downhill). See also Figure 3E (and Figure 3F Compared to a relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to a relatively large negative curvature). Such curves are often referred to as convex.

[0634] 5.8.6.2 Curvature of Two-Dimensional Surfaces

[0635] A description of the shape at a given point on a two-dimensional surface according to this technique may include multiple normal cross sections. These cross sections may cut the surface in a plane including an outward normal (“normal plane”), and each cross section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has a magnitude, such as a relatively small number. Figures 3B to 3F A planar curve in a plane can be an instance of multiple cross-sections at such a specific point.

[0636] Principal curvature and principal directions: The directions of the normal planes where the curvature of a curve reaches its maximum and minimum values ​​are called principal directions. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, the minimum curvature appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross-section along the principal direction. The principal curvature at point p is the curvature along the principal direction.

[0637] A region of a surface: a set of points connected together on a surface. The points in a region may have similar characteristics, such as curvature or sign.

[0638] Saddle-shaped region: The region where the principal curvature at each point has opposite signs, that is, one sign is positive and the other sign is negative (depending on the direction the hypothetical person is turning, they can walk uphill or downhill).

[0639] Dome region: A region where the principal curvature at each point has the same sign, such as two positive ("concave dome") or two negative ("convex dome").

[0640] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is not zero.

[0641] Planar region: A surface region where both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0642] Edge of a surface: the boundary or limit of a surface or region.

[0643] Path: In some forms of this technique, 'path' will be understood to mean a path in a mathematical-topological sense, such as a continuous spatial curve on a surface from f(0) to f(1). In some forms of this technique, 'path' can be described as a route or route, including, for example, a set of points on a surface. (The path of an imaginary person is where they walk on the surface and is similar to a garden path).

[0644] Path length: In some forms of this technique, 'path length' will be understood to mean the distance along the surface from f(0) to f(1), 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 an imaginary person would be the distance they walk along the path on the surface).

[0645] Straight-line distance: Straight-line distance is the distance between two points on a surface, but without considering the surface itself. In a planar region, there can exist a path on the surface with a path length equal to the straight-line distance between the two points. In a non-planar surface, there may not be a path with a path length equal to the straight-line distance between the two points. (For a hypothetical person, straight-line distance will correspond to the distance 'along a straight line'.)

[0646] 5.8.6.3 Space Curves

[0647] Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, meaning they have no endpoints. A space curve can be thought of as a one-dimensional block in three-dimensional space. Imagine a hypothetical person walking along a space curve on a DNA helix. The typical human left ear contains a helix, which is a left-handed helix; see [link to relevant documentation]. Figure 3Q The typical human right ear includes a spiral, which is a right-handed spiral; see [link / reference]. Figure 3R. Figure 3S A right-handed helix is ​​shown. The edges of a structure, such as the edges of a membrane or impeller, can follow a space curve. Generally, a space curve can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of how the curve turns away from the plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized by reference to the tangent vector, normal vector, and binormal vector at that point.

[0648] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point indicates the direction and magnitude from that point. The tangent unit vector is the unit vector at that point pointing in the same direction as the curve. If a hypothetical person were flying along the curve and fell off her vehicle at a specific point, the direction of the tangent vector would be the direction she would have traveled.

[0649] Unit normal vector: When an imaginary person moves along a curve, the tangent vector itself changes. The unit vector pointing in the same direction as the changing tangent vector is called the principal normal vector. It is perpendicular to the tangent vector.

[0650] 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 Alternatively, it can be done via the left-hand rule. Figure 3O To determine.

[0651] Oscillating plane: The plane containing both the unit tangent vector and the unit principal normal vector. See also Figure 3O and Figure 3P .

[0652] Torque of a space curve: Torque at a point on a space curve is the magnitude of the rate of change of the binormal vector at that point. It measures the degree to which the curve deviates from its osculating plane. A space curve lying on the osculating plane has zero torque. A space curve deviating relatively little from its osculating plane will have a relatively small torque value (e.g., a gently sloping spiral path). A space curve deviating relatively much from its osculating plane will have a relatively large torque value (e.g., a sharply sloping spiral path). Reference Figure 3S Since T2 > T1, it is located at Figure 3S The torsional value near the top loop of the spiral is greater than that located at the top loop. Figure 3S The value of the torsion of the bottom ring of the spiral.

[0653] refer to Figure 3P According to the right-hand rule, a space curve turning toward the direction of the right-hand binormal can be considered to have a right-hand positive twist (e.g., as...). Figure 3S (As shown in the right-handed spiral). A space curve that turns away from the direction of the right-hand binormal can be considered to have right-handed negative twist (e.g., a left-handed spiral).

[0654] Similarly, and referring to the left-hand rule (see...) Figure 3O A space curve that turns toward the left-hand secondary normal can be considered to have a left-hand positive twist (e.g., a left-hand spiral). Therefore, a left-hand positive is equivalent to a right-hand negative. See also Figure 3T .

[0655] 5.8.6.4 holes

[0656] Surfaces can have one-dimensional pores, such as pores defined by planar curves or spatial curves. Thin structures with pores (e.g., films) can be described as having one-dimensional pores. See, for example, [link to relevant documentation]. Figure 3I The structure shown has a one-dimensional hole on its surface, which is defined by a planar curve.

[0657] The structure can have two-dimensional pores, such as pores defined by a surface. For example, an inflatable tire has two-dimensional pores defined by the inner surface of the tire. In another example, a capsule having a cavity for air or gel can have two-dimensional pores. See, for example, [link to relevant documentation]. Figure 3L The mat and Figure 3M and Figure 3N An exemplary cross-section passing through it is shown, illustrating a two-dimensional orifice defined by an inner surface. In yet another example, the conduit may include a one-dimensional orifice (e.g., at its inlet or outlet) and a two-dimensional orifice defined by the conduit's inner surface. See also Figure 3K The two-dimensional hole shown is through the structure and is defined by the surface shown.

[0658] 5.9 Other Notes

[0659] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other value or intermediate value within the range are broadly included within this technology. The upper and lower limits of these intermediate ranges may be included independently within the intermediate range and within the scope of this technology, but are subject to any explicitly excluded boundaries within the range. When the range includes one or both of these boundaries, the range excluding one or both of those included boundaries is also included within the scope of this invention.

[0660] Furthermore, where one or more values ​​described herein are implemented as part of this technology, it should be understood that such values ​​may be approximate, and unless otherwise stated, these values ​​may be used to any suitable significant number to the extent permitted or required by the actual technical implementation.

[0661] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this art pertains. While any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of the techniques of this invention, a limited number of exemplary methods and materials are described herein.

[0662] When a particular material is deemed to be used to construct a component, an obvious alternative material with similar properties may be used as its substitute. Furthermore, unless otherwise stated, any and all components described herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0663] It must be noted that, unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” as used herein and in the appended claims include their plural equivalents.

[0664] All disclosures mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of those disclosures. The publications discussed herein are provided only because they were disclosed prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology is not entitled to precedence over these publications due to prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, and the publication dates may require independent verification.

[0665] The terms “comprises” and “comprising” should be interpreted as referring to an element, component, or step in a non-exclusive manner, indicating that the mentioned element, component, or step may exist, be used, or be combined with other elements, components, or steps not expressly mentioned.

[0666] The main headings used in the detailed description are included for the reader's convenience only and should not be used to limit the subject matter of the invention as found throughout the disclosure or claims. These headings should not be used to interpret the scope or limitation of the claims.

[0667] Although the present invention has been described with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the invention. In some cases, proper nouns, terms, and symbols may imply specific details not required for practicing the present invention. For example, although the terms "first" and "second" may be used, they are not intended to indicate any order unless otherwise specified, but rather to distinguish different elements. Furthermore, although the process steps in a method may be described or illustrated in a certain order, this order is not mandatory. Those skilled in the art will recognize that this order can be modified, and / or aspects thereof can be performed simultaneously or even concurrently.

[0668] Therefore, it should be understood that various modifications can be made to the exemplary instance and other arrangements can be designed without departing from the spirit and scope of this technology.

[0669] 5.10 List of reference numerals

[0670]

[0671]

[0672]

[0673]

Claims

1. A patient interface, comprising: An inflation chamber, which at least partially forms a patient interface chamber, is pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure. The inflation chamber includes a first inflation chamber orifice and a second inflation chamber orifice, each of which is sized and configured to receive an airflow at the treatment pressure for patient respiration. A sealing structure is configured and arranged to form a seal with a region of the patient’s face surrounding the patient’s airway inlet, the sealing structure having at least one hole therein such that an airflow under the therapeutic pressure is delivered to at least the patient’s nostrils, the sealing structure being configured and arranged to maintain the therapeutic pressure in the patient interface chamber throughout the patient’s respiratory cycle during use. A catheter assembly comprising a first catheter and a second catheter, each of the first catheter and the second catheter being sized and configured to receive an airflow at the therapeutic pressure for breathing of the patient, the first catheter and the second catheter being made of silicone, and each of the first catheter and the second catheter being configured to pass through between the corresponding patient's eye and ear along a corresponding side of the patient's head. A first catheter connector is removably connected to the inflation chamber at the first inflation chamber orifice and configured to pneumatically connect the first catheter to the first inflation chamber orifice to provide an airflow at the treatment pressure to the patient interface chamber for the patient to breathe. A second catheter connector is removably connected to the inflation chamber at the second inflation chamber orifice and configured to pneumatically connect the second catheter to the second inflation chamber orifice to provide an airflow at the treatment pressure to the patient interface chamber for the patient to breathe; as well as A positioning and stabilizing structure configured to secure the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a pair of upper frenulum, each of which is constructed and arranged such that at least a portion of each upper frenulum covers, in use, a corresponding lateral region of the patient's head above the upper ear base point, and the positioning and stabilizing structure comprising a pair of lower frenulum, each of which is constructed and arranged such that at least a portion of each lower frenulum covers, in use, a corresponding lateral region of the patient's head below the lower ear base point. Each of the first catheter connector and the second catheter connector is made of a relatively rigid plastic material. Each of the first and second catheter connectors includes an anti-asphyxiation valve configured to allow the patient to breathe through their mouth from the surrounding environment without airflow through the first or second air chamber orifice. Each of the first catheter connector and the second catheter connector further includes a flange and a lower tether tab connected to the flange, each of the lower tether tabs further including a clip receiver configured to be removably connected to a corresponding clip to engage the lower tether. The positioning and stabilizing structure includes a pair of clips, each of which is configured to releasably connect a corresponding one of the lower straps to a corresponding one of the clip receivers. Each of the clips and each of the clip receivers includes a magnet that is oriented and charged to facilitate a removable connection.

2. The patient interface of claim 1, wherein each of the flanges further comprises a flange opening and a recess. in, Each of the lower tether tabs further includes a tab connector configured to connect each of the lower tether tabs to a corresponding one in the flange by passing through a corresponding flange opening and engaging a corresponding recess.

3. The patient interface as described in claim 1, wherein, Each of the clip receivers includes a notch, and each of the clips includes a protrusion, each protrusion being configured to engage a corresponding notch to restrict rotation of each clip relative to the corresponding clip receiver.

4. The patient interface of claim 1, wherein the sealing structure further comprises a nasal opening configured to provide pneumatic communication between the patient's nostril and the patient interface chamber, and in, The sealing structure also includes an oral cavity portion orifice configured to provide pneumatic communication between the patient's mouth and the patient interface chamber.

5. The patient interface of claim 1, wherein the catheter assembly comprises: A connection port housing, each of the first conduit and the second conduit being pneumatically connected to the connection port housing, and A bend, rotatably and detachably connected to the connection port housing, is configured to connect to an air circuit to receive airflow under therapeutic pressure, and includes a plurality of vents.

6. The patient interface of claim 5, wherein the catheter assembly is configured to hold the connection port housing and the bend in a position above the patient's head during use.

7. The patient interface as described in claim 1, wherein, The anti-asphyxiation valve in each of the first and second catheter connectors includes an anti-asphyxiation valve orifice.

8. The patient interface as described in claim 7, wherein, The shape and size of each anti-asphyxiation valve orifice are configured to allow the patient to breathe through it when another anti-asphyxiation valve orifice is blocked.

9. The patient interface as described in claim 7, wherein, The anti-asphyxiation valve in each of the first and second catheter connectors further includes an anti-asphyxiation valve flap.

10. The patient interface as described in claim 9, wherein, The anti-asphyxiation valve flap of each of the first and second catheter connectors is configured to close the anti-asphyxiation valve orifice of the corresponding one of the first and second catheter connectors when in the closed position, such that the airflow under the treatment pressure traveling through the corresponding one of the first and second catheter connectors is directed to the patient interface chamber and prevented from escaping to the atmosphere via the anti-asphyxiation valve orifice throughout the patient's respiratory cycle.

11. The patient interface as described in claim 9, wherein, When in the open position, the anti-asphyxiation valve of each of the first and second catheter connectors is configured to allow the patient to breathe from the surrounding environment through their mouth via the anti-asphyxiation valve orifice of the corresponding one of the first and second catheter connectors without pressurized airflow passing through the first and second inflation chamber orifices.

12. The patient interface as claimed in claim 9, wherein, The anti-suffocation valve orifice of each of the first and second catheter connectors is separated by an anti-suffocation valve orifice separator that prevents the corresponding anti-suffocation valve flap from passing through the anti-suffocation valve orifice.

13. The patient interface as described in claim 9, wherein, The anti-asphyxiation valve of each of the first and second catheter connectors further includes an anti-asphyxiation valve flap connector orifice, and Each of the first catheter connector and the second catheter connector includes an anti-asphyxiation valve valve connector to connect the anti-asphyxiation valve valve to the anti-asphyxiation valve valve connector hole of a corresponding one of the first catheter connector and the second catheter connector.

14. The patient interface of claim 1, wherein the anti-asphyxiation valve of each of the first catheter connector and the second catheter connector is configured to operate independently of each other.

15. The patient interface of claim 1, wherein the inflation chamber includes one or more inflation chamber vents.

16. The patient interface of claim 1, further comprising a seal constructed of an elastomeric material, wherein a corresponding portion of the first and second air chamber openings of the seal is located between each of the first and second catheter connectors and the air chamber.

17. The patient interface of claim 16, wherein the seal is formed on each of the first catheter connector and the second catheter connector.

18. The patient interface of claim 1, wherein the sealing structure is made of silicone and the air chamber is made of transparent polycarbonate.

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