Connector assembly

Abstract

A patient interface for delivering a flow of air at positive pressure relative to ambient air pressure to an entrance to the patient's airways to ameliorate sleep disordered breathing comprises a seal-forming structure to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, and a connector assembly adapted to connect to an air circuit. The connector assembly comprises a loop member removably and releasably secured in an aperture of an attachment region of the patient interface and an elbow assembly connected to the air circuit and repeatedly connectable to and detachable from the loop member. The elbow assembly comprises an elbow member and a clip member. The clip member comprises a structure separate and distinct from the elbow member and is connected to the elbow member and releasably connects the elbow assembly to the loop member, the elbow member forming a seal with the loop member when the elbow assembly and loop member are connected to each other.

Description

[0001] This application is a divisional application of Chinese application No. 201980015159.1, filed on February 1, 2019, entitled "Connector Assembly". Application No. 201980015159.1 is an international application PCT / AU2019 / 050072 that entered the Chinese national phase.

[0002] This patent document contains a portion of copyrighted material. The copyright holder does not object to any faxed copy of this patent document or patent disclosure as it appears in the patent office's patent documents or records, but retains all copyrights.

[0003] 1. Cross-references to related applications

[0004] This application claims the benefit of U.S. Provisional Application No. 62 / 625,571, filed February 2, 2018, the entire contents of which are incorporated herein by reference. 2 Background Technology

[0006] This technology relates to one or more of the following: 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 related technologies

[0008] 2.2.1 The human respiratory system and its disorders

[0009] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airway.

[0010] The airways consist of a series of branching tubes, 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 carbon dioxide to be expelled in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the airway and do not participate in gas exchange. Further airway divisions result in respiratory bronchioles, which eventually lead to alveoli. The alveolar regions of the lungs are where gas exchange occurs and are known as respiratory zones. See *Respiratory Physiology*, 9th edition, by John B. West, Lippincott Williams & Wilkins, 2012.

[0011] A range of respiratory 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-related hyperventilation symptoms (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. This is caused by an abnormally small upper airway in the areas of the tongue, soft palate, and posterior oropharyngeal wall during sleep, coupled with a loss of normal muscle tone. The condition causes affected individuals to stop breathing, typically for periods ranging from 30 to 120 seconds, sometimes 200 to 300 times per night. It often leads to excessive daytime sleepiness and can potentially cause cardiovascular disease and brain damage. Although affected individuals may not be aware of the problem, this symptom is a disorder particularly common in middle-aged, overweight men. 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 vigorous and dexterous ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to repeated hypoxia, CSR can be detrimental. In some patients, CSR is associated with repeated awakenings 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 the term for a respiratory disorder in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can encompass some or all of the following disorders.

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

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

[0018] Chronic obstructive pulmonary disease (COPD) includes any of a group of lower airway diseases that share certain common characteristics. These include increased resistance to air movement, 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 shortness of breath on exertion, chronic cough, and excessive sputum production.

[0019] Neuromuscular diseases (NMD) are a broad term encompassing many diseases and ailments 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 walking ability, wheelchair confinement, dysphagia, 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 within months and leads to death within years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over many years and only slightly reduces life expectancy (e.g., limb girdle, scapular humerus, and myotonic dystrophy). Symptoms of respiratory failure in NMD include: increased generalized weakness, dysphagia, difficulty breathing at exertion and rest, fatigue, somnolence, morning headache, and difficulty with attention and mood changes.

[0020] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the chest cage. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can lead to severe respiratory failure. Symptoms of respiratory failure include: forced 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 improve these symptoms. Furthermore, other healthy individuals can utilize these treatments to prevent respiratory distress. However, these methods have many drawbacks.

[0022] 2.2.2 Treatment

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

[0024] Continuous positive airway pressure (CPAP) has been used to treat obstructive sleep apnea (OSA). Its mechanism of action is similar to that of a pneumatic splint, which acts by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall, preventing upper airway obstruction. Treatment for OSA with CPAP can be voluntary, therefore, if the patient finds the device used to provide this treatment to be any of the following: uncomfortable, difficult to use, expensive, and unsightly.

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

[0026] Invasive ventilation (IV) provides ventilatory support to patients who can no longer 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 therapies can be provided by treatment systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor symptoms without treating them.

[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 form of treatment system is the mandibular repositioning device.

[0031] 2.2.3.1 Patient Interface

[0032] A patient interface may, for example, be used to connect a breathing device to its wearer by providing an airflow to an inlet into the airway. The airflow may be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface may 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 approximately 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 approximately 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 the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient pressure.

[0034] Certain masks may be clinically disadvantageous for this technique, for example, if they 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 create and maintain a seal through their lips, this may be uncomfortable or impractical for this technology.

[0036] Some masks may not be suitable for use while sleeping, such as when sleeping on your side in bed with your head on a soft pillow.

[0037] The design of the patient interface presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose 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 jawbone or mandible can move relative to other bones in the skull. The entire head can move during respiratory therapy.

[0038] Due to 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 reduced adherence, decreased comfort, and poorer patient outcomes. Face shields designed solely for pilots, those designed as part of personal protective equipment (e.g., filtering face shields), SCUBA face shields, or those 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. Patients may not adhere to therapy if the mask is uncomfortable or difficult to use. Since patients are often advised to clean their masks regularly, they may not clean their masks if they are difficult to clean (e.g., difficult to assemble or disassemble), which could affect patient adherence.

[0040] While masks designed for other applications (such as navigators) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable 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] The patient interface may include a seal-forming structure. Since the seal-forming structure comes into direct contact with the patient's face, its shape and configuration 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. This single element may be designed, for example, to cover the upper lip region and the 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 sensitive areas of a patient's face differ. For instance, a seal on swimming goggles that cover a patient's forehead may not be suitable for use on a patient's nose.

[0046] Certain seal-forming structures can be designed for mass production, making a design suitable and 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 seal-forming 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 is designed to seal against the patient's face when force is applied to the patient interface and the seal-forming portion engages face-to-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 incorporates 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 part, 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 seal formation can be achieved using adhesives. Some patients may find it inconvenient to frequently 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 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0052] One form of nasal pillow was found in the 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 manufactures the following products that combine nose pillows: SWIFT TM Nose pillow mask, SWIFT TM II 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 Limited describes an example of a nose pillow mask: International Patent Application WO 2004 / 073,778 (particularly describing ResMed Limited SWIFT). TM (Regarding the nose pillow), US Patent Application 2009 / 0044808 (particularly describing ResMedLimited SWIFT) TM (Regarding the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe ResMed Limited MIRAGE LIBERTY) TM (All aspects of the full-face mask); International Patent Application WO 2009 / 052,560 (which describes ResMed Limited 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 corresponding force from the air pressure that threatens to break the seal. Therefore, various techniques have been used to position the sealing structure and maintain a proper seal 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, the use of 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: ill-fitting, bulky, uncomfortable, and awkward 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 deliver one or more of the aforementioned treatments, for example, by operating the device to generate an airflow for delivery to an airway interface. The airflow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0060] Air pressure generators are known in applications such as industrial-scale ventilation systems. However, air pressure generators for medical applications 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] An example of a specific requirement for certain RPT devices is noise.

[0062] A table showing the noise output levels of an existing RPT device (only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0063] RPT device name A-weighted sound pressure level in 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 ResMedStellar ventilator for adults and children, are also mentioned. TM The series can provide invasive and non-invasive non-dependent ventilation support for a range of patients to treat a variety of disorders, such as, but not limited to, NMD, OHS and COPD.

[0065] ResMed Elisée TM150 ventilators and ResMed VS III TM Ventilators provide support for invasive and non-invasive dependent ventilation for adult or pediatric patients, treating a variety of conditions. These ventilation devices offer volume-based and pressure-based ventilation modes with single-limb or dual-limb circuits. RPT devices typically contain a pressure generator, such as a motor-driven blower or a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, the airflow can be supplied to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0066] The designer of a device may be presented with an almost infinite number of options. Design standards often conflict, meaning that some design choices are far from 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 airflow without humidification can lead to airway dryness. Using a humidifier with an RPT device and patient interface to produce humidified gas minimizes dryness of the nasal mucosa and increases 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 range of artificial humidification devices and systems are known, however 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 the ambient air. Small medical humidifiers may be placed beside the bed. 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 the patient breathes; however, these systems also humidify and / or heat the entire room, which may 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 not humidify adequately, and some may be difficult or inconvenient for patients to use.

[0072] 2.2.3.4 Data Management

[0073] There may be clinical reasons for obtaining data to determine whether a patient prescribed respiratory therapy has been "adherent," such as the patient having used their RPT device according to one or more "adherence rules." An example of an adherence rule for CPAP therapy is that, to achieve adherence, a patient is required to use their RPT device for at least four hours per night for at least 21 out of a 30-day period. To determine patient adherence, RPT device providers (such as healthcare providers) may manually obtain data describing the treatment of patients using their RPT devices, calculate usage over a predetermined time period, and compare it to adherence rules. Once a healthcare provider has determined that a patient has used their RPT device according to compliance rules, the healthcare provider can then know that the third-party patient is adherent.

[0074] There may be other aspects of patient treatment that would benefit from communication of treatment data to third-party or external systems.

[0075] Existing processes for communicating and managing such 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] Mandibular repositioning devices (MRDs) or mandibular advancement devices (MADs) are one of the treatment options for sleep apnea and snoring. They are adjustable oral appliances available from dentists or other vendors that hold the mandible (jawbone) in a forward position during sleep. MRDs are removable devices that patients insert into their mouths before sleeping and remove afterward. Therefore, MRDs are not designed to be worn all the time. MRDs can be custom-made or manufactured in standard form and include an occlusal impression designed to allow for a proper fit to the patient's teeth. This mechanical protrusion of the mandible widens the space behind the tongue, applies tension to the pharyngeal walls to reduce airway collapse, and reduces palatal vibration.

[0078] In some examples, the mandibular advancement device may include an upper splint for engaging or fitting with teeth in the maxilla or maxilla, and a lower splint for engaging or fitting with teeth in the maxilla or mandible. The upper and lower splints are laterally connected together 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 remains in an advanced position when the MRD is placed in the patient's mouth. The length of the link can be adjusted to change the level of mandibular projection. The dentist can determine the level of mandibular projection, which will determine the length of the link.

[0080] Some MRDs are constructed to push the mandible forward relative to the maxilla, while others MADs (such as ResMedNarval CC) are designed to do so. TM The MRD (Mandibular Joint Reduction Device) is designed to hold the mandible in an forward position. The device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. 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 treatment systems may include vents to allow exhaled carbon dioxide to escape. Vents can allow gas to flow from the internal space of the patient interface, such as an inflation chamber, to the outside of the patient interface, such as the surrounding environment.

[0083] The vent may include an opening through which gas can flow during the use of the mask. Many such vents are noisy. Others may become blocked during use, thus providing insufficient flushing. Some vents may, for example, disturb the sleep of the patient's bed partner by causing noise or concentrated airflow.

[0084] ResMed has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 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 using the test method specified in ISO 3744 in CPAP mode at 10 cmH2O) The sound pressure levels for various objects are listed below.

[0088]

[0089]

[0090] 2.2.4 Screening, Diagnosis and Monitoring System

[0091] Polysomnography (PSG) is a routine system used for diagnosing and monitoring cardiopulmonary disorders, and it typically involves a clinician applying the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), and electromyography (EMG). PSG for sleep apnea involves observing the patient clinically for two nights: the first night for pure diagnosis, and the second night for the clinician to titrate treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep apnea.

[0092] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically provides a true / false result, 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 symptom progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0093] Clinical specialists can effectively screen, diagnose, or monitor patients based on visual observation of PSG signals. However, there are situations where access to clinical specialists may be unavailable or unaffordable. Different clinical specialists may hold differing opinions on a patient's condition. Furthermore, a given clinical specialist may apply different criteria at different times. 3. Summary of the Invention

[0095] This technology relates to providing a medical device for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, the medical device having one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0096] The first aspect of this technology relates to a device for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0097] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0098] One aspect of certain forms of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0099] One aspect of this technology relates to a connector assembly for a patient interface, the connector assembly comprising separately molded parts to reduce material constraints.

[0100] One aspect of this technology relates to a connector assembly for a patient interface that includes a low-profile button portion.

[0101] One aspect of this technology relates to a patient interface for delivering a flow of air at a positive pressure relative to ambient air pressure to the inlet of a patient's airway during sleep to improve sleep-disordered breathing. The patient interface includes: a sealing-forming structure configured and arranged to form a seal with a region of the patient's face surrounding the inlet of the patient's airway; a positioning and stabilizing structure providing forces for holding the sealing-forming structure in a therapeutically effective position on the patient's head; and a connector assembly adapted to connect to an air circuit. The connector assembly includes a ring member configured to be removably and releasably secured in an aperture in an attachment region of the patient interface and a bend assembly configured to connect to the air circuit. The bend assembly is repeatedly connected to and detached from the ring member. The bend assembly includes a bend member and a clamping member. The clamping member includes a separate and distinct structure from the bend member and is configured and arranged to connect to the bend member. The clamping member is configured and arranged to releasably connect the bend assembly to the ring member, and the bend assembly is configured and arranged to form a seal with the ring member when the bend assembly and the ring member are connected to each other.

[0102] One aspect of certain forms of this technology is an easy-to-use medical device, for example, that can be easily used by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using this type of medical device.

[0103] One aspect of this technology is a patient interface that can be used in a patient's home, for example, by washing it in soapy water, without the need for specialized cleaning equipment.

[0104] Of course, some of these aspects can form sub-aspects of this technology. Sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0105] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. 4. Attached Figure Descriptions

[0107] This technology is illustrated by way of example and not limitation in the figures, and similar reference numerals in the figures refer to similar elements, including:

[0108] 4.1 Treatment System

[0109] Figure 1AA 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 flows to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient sleeps in a supine position.

[0110] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 via 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 flows to the patient 1000 along an air circuit 4170.

[0111] Figure 1C A system is demonstrated in which a patient 1000 wearing a full-face mask-like patient interface 3000 receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and flows along an air circuit 4170 to the patient 1000. The patient sleeps in a side-lying position.

[0112] 4.2 Respiratory System and Facial Anatomy

[0113] Figure 2A It presents an overview of the human respiratory system, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0114] Figure 2B It shows a view of the human upper airway, including the nasal cavity, nasal bones, external nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0115] Figure 2C It is a frontal view of a face with several identifiable 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. Upward, downward, radially inward, and radially outward directions are also shown.

[0116] 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, subnasal septum, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, supraauricular base, and subauricular base. The vertical and anteroposterior directions are also marked.

[0117] Figure 2E This is another side view of the head. It indicates the approximate locations of the Frankfort angle and the nasolabial angle. The coronal plane is also marked.

[0118] Figure 2FThe bottom view of the nose is shown, featuring several distinctive features, 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 central sagittal plane.

[0119] Figure 2G A side view showing the surface features of the nose.

[0120] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0121] Figure 2I It shows an anatomical view of the nose about a few millimeters from the central sagittal plane, and among other things, shows the medial crus of the septal cartilage and the greater alar cartilage.

[0122] Figure 2J It shows a frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also labeled.

[0123] Figure 2K This diagram shows a side view of the skull, including the surface contours of the head and several muscles. 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 indicated. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0124] Figure 2L This is a frontal view of the nose.

[0125] 4.3 Patient Interface

[0126] Figure 3A A patient interface in the form of a nasal mask according to this technology is shown.

[0127] Figure 3B A schematic diagram of a cross-section of 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 amplitude shown is relatively large compared to that of the previous time.

[0128] Figure 3C A schematic diagram of a cross-section of 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 amplitude shown is relatively small compared to that of the previous time.

[0129] Figure 3D A schematic diagram showing a cross-section of the structure at a single point is provided. The outward normal at that point is indicated. The curvature at that point is zero.

[0130] Figure 3E A schematic diagram of the cross-section of 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 amplitude shown is relatively small compared to that of the previous time.

[0131] Figure 3F A schematic diagram of the cross-section of 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 amplitude shown is relatively large compared to that of the previous time.

[0132] Figure 3G A pad for a face mask that includes two pillows is shown. The outer surface of the pad is indicated. The edges of the surface are indicated. The dome-shaped area and the saddle-shaped area are indicated.

[0133] 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.

[0134] Figure 3I This illustrates a surface structure with a one-dimensional hole. The planar curves shown in the illustration form the boundary of the one-dimensional hole.

[0135] Figure 3J Showed through Figure 3I The cross-section of the structure. The surface shown in the diagram is... Figure 3I The structure defines a two-dimensional hole.

[0136] Figure 3K Showing Figure 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is... Figure 3I The surface of the two-dimensional hole is defined in the structure.

[0137] Figure 3L A face mask with an inflatable airbag serving as a cushion was displayed.

[0138] Figure 3M Showed through Figure 3L The image shows a cross-section of the mask and the inner surface of the airbag. This inner surface defines the two-dimensional openings in the mask.

[0139] Figure 3N Demonstrated through Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0140] Figure 3O The left-hand rule is shown.

[0141] Figure 3P The right-hand rule is shown.

[0142] Figure 3Q The left ear is shown, including the left ear spiral.

[0143] Figure 3R The right ear is shown, including the right ear spiral.

[0144] Figure 3S It demonstrates a right-handed spiral.

[0145] Figure 3T The image shows a view of the face mask, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the mask.

[0146] Figure 3U A view of the inflation chamber 3200 is shown, which displays the sagittal plane and the intermediate contact plane.

[0147] Figure 3V Showing Figure 3U This is a view of the rear of the inflation chamber. The direction of this view is perpendicular to the intermediate contact plane. Figure 3V The sagittal plane in the middle divides the air chamber into two equal parts, left and right.

[0148] Figure 3W Showed through Figure 3V The cross-section of the inflation chamber, which is in Figure 3V The image shows a cut-off point in the sagittal plane. An "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of this intermediate contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and contacts the pad of the inflation chamber at exactly two points on the sagittal plane (upper point 3220 and lower point 3230). Depending on the geometry of the pad in this region, the intermediate contact plane can be a tangent at the upper and lower points.

[0149] Figure 3X Showing Figure 3U The inflation chamber 3200 is positioned for use on the face. When the inflation chamber is in the use position, the sagittal plane of the inflation chamber 3200 approximately coincides with the central sagittal plane of the face. When the inflation chamber is in the use position, this intermediate contact plane generally 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 roughly located on the root of the nose, while the lower point 3230 is located on the upper lip.

[0150] Figure 4 This is a perspective view of the patient interface shown on the patient's head, based on an example of this technology.

[0151] Figure 5This is a rear perspective view of a connector assembly according to an example of this technology.

[0152] Figure 6 yes Figure 5 The front perspective view of the connector assembly shown.

[0153] Figure 7 yes Figure 5 Rear view of the connector assembly shown.

[0154] Figure 8 yes Figure 5 The front view of the connector assembly shown.

[0155] Figure 9 yes Figure 5 A top view of the connector assembly shown.

[0156] Figure 10 yes Figure 5 The bottom view of the connector assembly shown.

[0157] Figure 11 yes Figure 5 Side view of the connector assembly shown.

[0158] Figure 12 yes Figure 11 The cross-sectional view of the connector assembly shown.

[0159] Figure 13 yes Figure 12 The enlarged portion of the cross section.

[0160] Figure 14 yes Figure 9 The cross-sectional view of the connector assembly shown.

[0161] Figure 15 yes Figure 5 An exploded view of the connector assembly shown.

[0162] Figure 16 yes Figure 5 The side view of the bend assembly of the connector assembly shown.

[0163] Figure 17 yes Figure 16 The rear view of the bent pipe component shown.

[0164] Figure 18 yes Figure 16 The top view of the bent pipe component shown.

[0165] Figure 19 yes Figure 5 The bottom view of the clamping component of the connector assembly shown.

[0166] Figure 20yes Figure 15 The enlarged portion of the clamping component shown.

[0167] Figure 21 yes Figure 5 A perspective view of the ring member of the connector assembly shown.

[0168] Figure 22 yes Figure 21 The side view of the ring component shown.

[0169] Figure 23 It is a perspective view of a patient interface including a connector assembly according to an example of the present technology, wherein the bend assembly engages with the ring member.

[0170] Figure 24 It is a perspective view of a patient interface including a connector assembly according to an example of the present technology, wherein the bend assembly is detached from the ring member.

[0171] Figure 25 It is a cross-sectional view of a patient interface including a connector assembly according to an example of the present technology, wherein the bend assembly engages with the ring member.

[0172] Figure 26 It is a cross-sectional view of a patient interface including a connector assembly according to an example of the present technology, wherein the bend assembly is manually detached from the ring member.

[0173] Figure 27 This is a perspective view of a bent pipe component according to another example of this technology.

[0174] Figure 28 yes Figure 27 The top view of the bent pipe component shown.

[0175] Figure 29 yes Figure 27 The rear view of the bent pipe component shown.

[0176] Figure 30 yes Figure 27 The diagram shows a perspective view of a bent pipe assembly, in which a clamping member is connected to the bent pipe assembly.

[0177] Figure 31 This is a side view of an integral bend and clamp member according to another example of the present technology. 5. Detailed Implementation

[0179] Before describing this technology in further detail, it should be understood that this technology 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 only and is not intended to be limiting.

[0180] The following description provides various examples of which may share one or more common characteristics and / or features. It should be understood that one or more features of any example may be combined with one or more features of another example or other examples. Furthermore, in any example, any single feature or combination of features may constitute another example.

[0181] 5.1 Treatment

[0182] In one form, the technology includes a method for treating respiratory distress, the method comprising the step of applying positive pressure to the airway inlet of a patient 1000.

[0183] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0184] In some examples of this technology, mouth breathing is restricted, constrained, or prevented.

[0185] 5.2 Treatment System

[0186] In one form, the technology includes a device or apparatus for treating respiratory disorders. This device or apparatus may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 to a patient interface 3000, see, for example, [link to relevant documentation]. Figures 1A to 1C .

[0187] 5.3 Patient Interface

[0188] refer to Figure 3A According to one aspect of the present technology, the non-invasive patient interface 3000 includes the following functional aspects: a sealing formation structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects 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 formation structure 3100 is arranged around an inlet to the patient's airway to facilitate the supply of positive pressure air to the airway.

[0189] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0190] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide air at a positive pressure of at least 6 cmH2O relative to the environment.

[0191] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide air at a positive pressure of at least 10 cmH2O relative to the environment.

[0192] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide air at a positive pressure of at least 20 cmH2O relative to the environment.

[0193] Figure 4 A non-invasive patient interface 6000 according to one aspect of the present technology is illustrated. As shown, the patient interface 6000 includes the following functional aspects: a pad assembly 6150, a positioning and stabilizing structure 6300, and a connection port 6600 for connection to an air circuit 4170. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects.

[0194] The pad assembly 6150 includes a sealing formation 6100 and an inflation chamber 6200. In use, the inflation chamber 6200 receives a positive pressure air supply from the air circuit 4170, and the sealing formation 6100 is arranged to seal the area around the entrance to the patient's airway to facilitate the supply of positive pressure air to the airway.

[0195] exist Figure 4 In the illustrated form of the present technology, the positioning and stabilizing structure 6300 includes two tubes 6350 (e.g., made of flexible silicone) that deliver pressurized air from the RPT device to the patient's airway, for example, through an inflation chamber 6200 and a sealing forming structure 6100. Each tube 6350 is positioned on a different side of the patient's head during use and extends across the corresponding cheek region, above the corresponding ear (above the auricular base on the patient's head) to a connection port 6600 on the top of the patient's head.

[0196] The positioning and stabilizing structure 6300 may be referred to as a "headband" because it engages with the patient's head to hold the patient interface 6000 in a sealed position. The tube 6350 is an integral part of the headband 6300 of the patient interface 6000 to position and stabilize the sealing forming structure 6100 of the patient interface to an appropriate portion of the patient's face (e.g., nose and / or mouth). This allows a conduit providing a pressurized airflow through the air circuit 4170 to connect to the connection port 6600 of the patient interface, for example, in a location other than in front of the patient's face.

[0197] In some forms of this technology, the patient interface 6000 may include a connection port 6600 located near the top, side, or rear of the patient's head. For example, in Figure 4 In the form of the present technology shown, the connection port 6600 is located on the top of the patient's head.

[0198] exist Figure 4In the illustrated form of the technology, two tubes 6350 are fluidly connected to each other at their upper ends and fluidly connected to a connection port 6600. In one embodiment, the two tubes are integrally formed, while in other embodiments, the tubes are separate components that are connected together in use and can be disconnected, for example, for cleaning or storage.

[0199] An intermediate conduit portion or attachment region 6352 (e.g., made of flexible silicone) is provided to fluidly connect two tubes 6350 to each other at their upper ends. The intermediate conduit portion 6352 includes an opening or orifice that can be connected to a connection port 6600 in use. The intermediate conduit portion 6352 may be integrally formed with the two tubes, or it may be in the form of a separate connector including ends, each end of which can be fluidly connected to the corresponding tube 6350.

[0200] In one example, such as Figure 4 As shown, the positioning and stabilizing structure 6300 includes a back head strap 6310 connected between two tubes 6350 positioned on each side of the patient's head and passing around the back of the patient's head, for example, covering the occipital bone of the patient's head in use or located below the occipital bone of the patient's head.

[0201] In some forms of this technology, the positioning and stabilizing structure 6300 includes an adjustment mechanism 6360 configured to allow adjustment of the dimensions of the positioning and stabilizing structure 6300. For example, Figure 4 The patient interface 6000 shown includes a tube 6350, which includes a telescopic tube portion 6362 between the lengths of the tube 6350.

[0202] Further examples and details of the Patient Interface 6000 are described in PCT Publication WO 2017 / 124155, the contents of which are incorporated herein by reference in their entirety.

[0203] It should be understood that many aspects of this technology can be used with other suitable interface layouts and types, such as full face / nose interface, nose interface, and nose fork.

[0204] Connector assembly

[0205] Figures 5 to 26 A connection port 7600 for a patient interface 6000, according to another example of this technology, is shown. Although this technology has been described with reference to the patient interface 6000, it should be understood that the technology is not limited to such a specific example and can be adapted for use with other suitable interface arrangements and types.

[0206] In the example shown, the connection port 7600 is in the form of a connector assembly that is constructed and arranged to provide a releasable connection between the patient interface 6000 and the air circuit 4170.

[0207] Connector assembly 7600 includes a bend assembly 7700 configured to connect to air circuit 4170 (e.g., via spindle connector 7790) and a ring member 7900 configured to connect to patient interface 6000. As described in more detail below, bend assembly 7700 can be repeatedly engaged with and removably disengaged from ring member 7900 (i.e., connected to and disconnected from it) to facilitate a releasable or detachable connection between patient interface 6000 and air circuit 4170.

[0208] pipe bending assembly

[0209] The pipe bending assembly 7700 includes a pipe bending member 7710 having a first end 7712 and a second end 7714. In the example shown, the pipe bending member 7710 includes a 90° bend such that the first end 7712 is substantially perpendicular to the second end 7714, that is, the central axis of the first end 7712 is at a 90° angle to the central axis of the second end 7714. However, it should be understood that the first end 7712 and the second end 7714 can be arranged in alternative configurations, such as at angles that are not perpendicular to each other.

[0210] A clamping member 7730 is disposed on the first end 7712. In the example shown, the clamping member 7730 is constructed and arranged to provide a releasable connection with the ring member 7900, such as a releasable snap-fit ​​connection or a detachable snap-fit ​​assembly. The second end 7714 is provided with a swivel connector 7790 adapted for connection to the air circuit 4170 (e.g., a swivel connector 7790 permanently connected to the second end 7714).

[0211] pipe bending components

[0212] The first end portion 7712 of the bend member 7710 includes a recess 7715 configured and arranged to receive a clamping member 7730. The recess 7715 includes an upper recess 7715U extending along the upper portion of the bend member 7710. The upper recess 7715U leads to a side recess 7715S extending along a corresponding side of the bend member 7710. The depth of the recess 7715 is selected such that the clamping member 7730 provides a low profile, for example, a portion of the clamping member 7730 protrudes only slightly from the outer surface of the recess 7715 surrounding the bend member 7710.

[0213] Each side recess 7715S includes a lug 7716, which is configured and arranged to interact with the clamping arm 7740 of the clamping member 7730 to facilitate holding the clamping member 7730 on the bend member 7710 and operating the clamping arm 7740.

[0214] The first end portion 7712 also includes a tubular end portion 7713 configured to extend through the ring member 7900 and engage with a sealing member 7950 disposed on the ring member 7900 to provide a sealed airflow path for delivering pressurized gas through the bend assembly 7700 to the patient interface 6000.

[0215] The second end 7714 is provided with a rotary connector 7790. In one example, the rotary connector 7790 may overlay the tubular end 7717 formed to the second end 7714 (see, for example, see...). Figure 14 As shown in the figure, the tubular end 7717 includes a channel 7717C to receive a radially inwardly extending protrusion 7795 disposed on the swivel connector 7790, thereby axially holding the swivel connector 7790 on the second end 7714.

[0216] In addition, 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 6000. As shown, the vents 7720 are arranged in a column; however, it should be understood that they can be arranged in other suitable ways, e.g., concentrically. In one example, each vent 7720 may include a profile or tapering along its length, e.g., each vent converges in the direction of exhaust gas. However, each vent 7720 may have other suitable shapes to guide exhaust or flushing gas. Furthermore, in the example shown, 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 7710 having other shapes, such as circular or convex.

[0217] Clamping components

[0218] The clamping member 7730 includes a pair of resilient, quick-release clamping arms 7740 and a connecting portion 7760 that interconnects the clamping arms 7740 (i.e., clamping arms 7740) located at each end of the connecting portion 7760.

[0219] Each clamping arm 7740 includes a latching portion 7750 and a button or trigger portion 7780. The clamping arm 7740 is configured and arranged to provide a releasable latch-on engagement with or a detachable latch-on connection assembly to the ring member 7900, for example, by deflecting and latching the latching portion 7750 into a recess or undercut on the ring member 7900. The button portion 7780 is configured and arranged to manually clamp or compress to deflect the latching portion 7750 for disengaging or releasing the latching portion 7750 from the ring member 7900, and thus allowing the bend assembly 7700 to disengage from the ring member 7900.

[0220] Each latching portion 7750 includes a barb end, rib, or latch 7755 configured to provide a fastening connection assembly with the ring member 7900. In the example shown, the latch 7755 includes an inlet angle to facilitate push assembly and a 90° return angle to resist or prevent pull-out disassembly; for example, the user must deflect the latching portion 7750 via the button portion 7780 to allow disassembly. Each button or trigger portion 7780 includes a finger grip portion 7781 (e.g., a recess) adjacent to the free end of the clamping arm 7740. Furthermore, each holding portion 7750 has a recess 7757 on its inner surface to facilitate holding the clamping member 7730 on the bent tube member 7710 and operating the clamping arm 7740.

[0221] Connection between clamping member and bend member

[0222] In the example shown, clamping member 7730 and bending member 7710 comprise separately molded parts (i.e., separate and distinct structures) that are subsequently joined together, for example, via a snap-fit ​​connection. For instance, clamping member 7730 may be made of a more flexible material than that of bending member 7710, thereby allowing clamping member 7730 to bend at and attach to a first end 7712 of bending member 7710. In the example, retaining arrangements are provided to connect or secure the clamping member to the bending member, for example, via a snap-fit ​​connection or snap-fit ​​assembly.

[0223] In the example shown, clamping member 7730 includes an open-end configuration with a semi-flexible and generally semi-circular connection 7760 that allows clamping member 7730 to be connected to, for example, a bent tube member 7710 in a manner similar to an open spring coil.

[0224] For example, the connecting portion 7760 of the clamping member 7730 and the upper recess 7715U of the bend member 7710 can be constructed and arranged to be at least partially aligned with each other along the assembly direction, and the connecting portion 7760 is constructed and arranged to engage above and fit into the upper recess 7715U, for example, by snapping or clamping in place, so as to reliably and releasably interconnect the clamping member 7730 and the bend member 7710 in the assembled position. The connecting portion 7760 is formed in a semi-circular or arcuate shape and has a sufficiently small cross-section; the connecting portion is generally semi-flexible or bendable so that the clamping member 7730 can be clamped around and over the bend member 7710.

[0225] The connecting portion 7760 of the clamping member 7730 is constructed and arranged to provide one or more functions. For example, the connecting portion 7760 provides a structure for attaching the clamping member 7730 to the bend member 7710. The connecting portion 7760 has a shape configured to fit into an upper recess 7715U of the bend member 7710, and structural stiffness sufficient to hold the clamping member 7730 in a proper position on the bend member 7710. In one example, the clamping member 7730 is flexible enough to allow removal; for example, the clamping member may not be so rigid that it cannot be removed. However, in an alternative example, the clamping member 7730 may be non-removably connected to the bend member 7710; for example, the clamping member may be rigid, making it impossible to remove. In the example where the clamping member 7730 is removable, the bending capability of the connecting portion 7760 provides the ability for the clamping member 7730 to be removed. Similarly, the resistance to bending provided by the connection 7760 provides the ability to keep the clamping member 7730 in place on the bent member 7710.

[0226] In one example, the latching portion 7750 of the clamping member 7730 can be biased inward so that when the clamping member 7730 is connected to the bend member 7710, the latching portion 7750 is biased inward to clamp the bend member 7710 and provide further resistance to removal from the bend member 7710.

[0227] The snap-fit ​​portion 7750 also features for retaining the clamping member 7730 on the bent member 7710. Specifically, each of the clamping arms 7740 is constructed and arranged to engage with a corresponding one of the side recesses 7715S, such that a recess 7757 on the inner surface of each snap-fit ​​portion 7750 is configured to receive a lug 7716 provided in the corresponding side recess 7715S. Such a connection arrangement (e.g., a latching connection assembly) further retains the clamping member 7730 on the bent member 7710, i.e., the snap-fit ​​portion 7750 needs to deflect on the corresponding lug 7716 to separate the clamping member 7730 from the bent member 7710. The connecting portion 7760 provides resistance to bending to prevent such separation from occurring.

[0228] In the illustrated example, the bent tube member 7710 and the clamping member 7730 provide a two-part assembly or construction. An exemplary advantage of this two-part structure is that it allows for manufacturing with fewer restrictions on materials. For example, the clamping member 7730 and the bent tube member 7710 comprise separately molded parts, resulting in less interdependence between them; for instance, the clamping member 7730 is not limited by the material of the bent tube member 7710. In one example, the clamping member 7730 and the bent tube member 7710 comprise different materials and / or different material properties relative to each other. In another example, the clamping member 7730 and the bent tube member 7710 are not molded as a single piece from the same material.

[0229] In one example, the bend member 7710 may be made of a more rigid material (e.g., polycarbonate) than the material of the clamping member 7730 (e.g., nylon-12). The material of the clamping member 7730 (e.g., nylon-12) may be relatively flexible and robust, for example, facilitating the flexing of the clamping arm, resisting abrasion, and maintaining the connection to the bend member. The material of the bend member 7710 (e.g., polycarbonate) may be relatively rigid, for example, abrasion resistant, easy to clean, and easy to manufacture.

[0230] Furthermore, this two-part construction allows each part to be less geometrically complex, resulting in components that can be used to manufacture simpler tools.

[0231] In the example shown, clamping member 7730 is constructed and arranged to provide a releasable connection, such as a snap-fit ​​connection, to bending member 7710. This releasable or separable arrangement facilitates cleaning of clamping member 7730 and bending member 7710 upon separation.

[0232] In an alternative example, clamping member 7730 may be non-removably connected to bend member 7710; for example, clamping member may be permanently connected to bend member. This non-removable arrangement may be advantageous because it reduces the possibility of clamping member loss or breakage. Since clamping member is outside the airflow path, thorough cleaning may not be necessary, for example, compared to components exposed to the airflow path.

[0233] In one example, clamping member 7730 and bending member 7710 may comprise separately molded parts that are subsequently permanently joined together, such that clamping member 7730 can remain connected to bending member 7710. Any suitable means may be used to permanently connect or join the clamping member and the bending member.

[0234] In one example, clamping member 7730 and bend member 7710 may be welded or joined to each other, for example, by ultrasonic welding. For instance, clamping member 7730 may be attached to bend member 7710 as described above, and then one or more portions (e.g., the central portion) of the connecting portion 7760 of clamping member 7730 may be welded or joined to bend member 7710 to permanently secure the clamping member to the bend member. This connection will allow the connecting portion to provide sufficient torsion (and torsional resistance) to operate clamping arm 7740.

[0235] Alternatively, the bend assembly can be configured to allow the clamping member to be easily assembled to the bend assembly, but the structure of the bend assembly and / or clamping member makes disassembly difficult or challenging. Such a bend assembly with separately manufactured bend and clamping members achieves the desired advantages (e.g., fewer constraints on material selection) while avoiding additional welding or joining operations to secure the clamping member to the bend assembly.

[0236] For example, such as Figure 27-30 As shown, the bend member 7710 may include tabs or stops 7719 along the upper edge of each side recess 7715S. Each tab 7719 protrudes generally laterally outward from the bottom of the bend member away from the corresponding side recess. When the clamping member 7730 is attached to the bend member 7710, the tabs or stops 7719 are arranged to make disassembly of the clamping member from the bend member more difficult. That is, these tabs or stops 7719 are arranged such that the clamping arms of the clamping member must further deviate from each other to move away from these tabs or stops 7719 in order to separate.

[0237] like Figure 30As shown, when the clamping member 7730 is connected to the bend member 7710, the tab 7719 protrudes outward and extends beyond the side of the clamping member 7730 to provide resistance preventing the clamping member 7730 from being removed from or "unfolding" from the recess 7715 of the bend member. The tab 7719 is located above the snap-fit ​​portion 7750 and behind the connecting portion 7760 of the clamping member (as shown). Figure 30 (As seen in the image), this positioning helps prevent the latch 7750 from being pushed upwards and backwards.

[0238] The bend assembly 7700 may also have a structure that helps prevent the latching portion 7750 from being pushed forward to remove the clamping member 7730 from the bend assembly 7710. In the example shown, the first end 7712 of the bend member 7710 includes a radially outwardly extending ridge or flange 7722, which acts as a stop to prevent the bend assembly 7700 from being over-inserted into the ring member 7900, i.e., when the bend assembly is fully inserted into the ring member 7900, the flange 7722 abuts against the ring member 7900 (e.g., see...). Figure 12 In one example, such as Figure 29 As shown, a portion of the flange 7722 may be wider (i.e., the widened portion extends further radially outward) to form a shelf 7723, for example, at least along the edge of the upper recess 7715U of the bend member 7710 adapted to receive the connecting portion 7760 of the clamping member 7730. The shelf 7723 can serve as a stop to help prevent the connecting portion 7760 and thus the entire clamping member 7730 from being pushed forward out of the upper recess 7715U of the bend member 7710.

[0239] Ring component

[0240] The ring member 7900 is configured to be removably and sealingly secured in an opening or orifice of the patient interface 6000, specifically in the orifice 6355 of the intermediate conduit portion 6352 that interconnects the two tubes 6350 of the headband 6300 (see [reference]). Figures 23 to 26 ).

[0241] like Figure 22 As best shown, when the ring member 7900 is secured in the orifice 6355, the ring member 7900 includes a first side 7910 adapted to be positioned inside the intermediate guide portion 6352 and a second side 7920 adapted to be positioned outside the intermediate guide portion 6352. The ring member 7900 includes a first flange 7915 on the first side 7910 and a second flange 7925 on the second side 7920. The first flange 7915 and the second flange 7925 define a headband channel 7930 that sealably engages the intermediate guide portion 6352 of the headband 6300 when the ring member 7900 is secured in the orifice 6355; that is, the circumferential surface of the channel 7930 is adapted to sealably engage the lip 6354 defining the orifice 6355 in the intermediate guide portion 6352 (see, for example, [reference needed]). Figure 25 and 26 ).

[0242] When the lip portion 6354 engages within the channel 7930, the ring member 7900 is secured in a substantially fixed position (i.e., the headband fits between the first flange 7915 and the second flange 7925 to help prevent the ring member 7900 from unintentionally separating from the headband) and cannot rotate freely due to surface friction. Furthermore, this engagement prevents airflow through the orifice 6355 between the ring member 7900 and the intermediate conduit portion 6352. The ring member 7900 can be removed from the patient interface 6000 (e.g., for cleaning, examination) by peeling the silicone material of the intermediate conduit portion 6352 from the ring member 7900.

[0243] The ring member 7900 also includes a clamping flange 7940, which is configured and arranged to engage the clamping member 7730 when the bend assembly 7700 is releasably engaged with the ring member 7900. A second flange 7925 is disposed adjacent to the clamping flange 7940, such that the clamping flange 7940 and the second flange 7925 define a clamping channel 7945 for matingly receiving a snap 7755 of the clamping member 7730. In the example shown, the clamping flange 7940 provides an entry angle (e.g., a ramp or bevel) in the assembly direction to facilitate pushing the bend assembly 7700 onto the ring member 7900. The clamping flange 7940 also provides a 90° return angle to resist or prevent pull-out disassembly, for example, requiring the user to deflect the snap 7750 via the button portion 7780 to allow disassembly.

[0244] The ring member 7900 also includes a sealing member 7950 along its inner periphery adjacent to the first side 7910. The sealing member 7950 is configured and arranged to provide a seal between the ring member 7900 and the bend assembly 7700 when the bend assembly 7700 is attached to the ring member 7900.

[0245] Releasable connection between bend assembly and ring member

[0246] The bend assembly 7700 is releasably connected to the ring member 7900 via a clamping arm 7740 (e.g., a snap-fit ​​or snap-connection assembly). Specifically, the clamping channel 7945 is configured to receive ribs or snaps 7755 of each snap portion (e.g., ribs or snaps are arranged to engage, grip, or hook the clamping flange to provide a secure connection) to releasably hold the bend assembly 7700 to the ring member 7900 and form a swivel connection, i.e., allowing the bend assembly 7700 to rotate freely 360° relative to the ring member 7900 about the axis of the ring member 7900. That is, the ribs or snap portions 7755 at the free end of each snap portion 7750 are configured, for example, to engage above and behind the clamping flange 7940 via a snap-fit ​​to releasably connect the bend assembly 7700 to the ring member 7900 and prevent accidental disengagement.

[0247] The inclined surface or ramp 7941 of the clamp flange 7940 in the assembly direction is configured to make it easier and smoother to attach the bend assembly 7700 to the ring member 7900. During the attachment of the bend assembly 7700 to the ring member 7900, its latching portions 7750 and 7755 must be forced to radially outward deflect or pivot to engage the latch flange 7940 and subsequently receive the latch flange 7940, and to twist each side of the connection portion 7760. Minimizing this force improves the usability of the bend assembly. The inclined surface 7941 of the clamp flange 7940 and the lead-in angle of the latch 7755 allow the force applied to the clamping member to extend a greater distance, reducing the force required to unfold the latching portions and improving usability.

[0248] The button portion 7780 can be manually clamped or squeezed at the end opposite to the corresponding latch 7755 so that the latch 7755 disengages from the clamping flange 7940 on the ring member 7900.

[0249] Lugs 7716 within each side recess 7715S of the bend member 7710 function as fulcrums and bottom stops. In the example shown, the lugs 7716 are T-shaped. The lateral portions of the T-shaped lugs 7716 serve as fulcrums on which the corresponding latching portions 7750 pivot. As described above, each latching portion 7750 pivots during engagement to receive the clamping flange 7940 of the ring member 7900. Additionally, each latching portion 7750 pivots during disengagement via a corresponding button portion 7780. Figure 26 The latch portion is shown as pivoting when the button portion 7780 is manually clamped or pressed, causing the latch 7755 to disengage from the clamping flange 7940 on the ring member 7900.

[0250] When the button is manually released, the legs of the T-shaped lug 7716 act as a stop to prevent the corresponding latch 7750 from lowering to its lowest point when pivoted to its operating connection position. Alternatively, or additionally, a flange may be provided around the body of the bent tube member, below the clamping member, to act as a stop, thereby limiting the movement of the latch.

[0251] Another function of the connecting portion 7760 of the clamping member 7730 is to provide resistance to the pivoting of the latching portion 7750. As described above, the latching portion 7750 pivots to receive and release the clamping flange 7940 of the ring member 7900. However, the latching portion preferably does not pivot when the user does not apply pressure to the button portion; otherwise, the clamping member would not function to secure the bent tube member to the ring member. The connecting portion of the clamping member is substantially collinear with the latching portion about its pivot point to each latching portion. Pivoting of the latching portion causes torsion in the connecting portion. Therefore, the connecting portion 7760 is designed to have sufficient structural rigidity to provide sufficient resistance to torsion so that the latching portion does not pivot unnecessarily. However, the connecting portion must allow a certain amount of torsion to allow the latching portion to pivot, thereby enabling the latch to receive the clamping flange of the ring member and release the clamping flange from the ring member when the button portion is manually clamped or squeezed by the user.

[0252] Seal between the bend assembly and the ring assembly

[0253] The ring member 7900 includes a sealing member 7950, such as a flexible flange or radial lip seal arranged to engage the bend assembly 7700 to provide a seal for the airflow path when the bend assembly 7700 is connected to the ring member 7900. In the illustrated example, the sealing mechanism is separate from the retaining features; for example, the bend member 7710 is adapted to form a seal with the ring member 7900, while the clamping member 7730 is adapted to releasably connect the bend assembly to the ring member 7900.

[0254] like Figure 12 and Figure 13 As shown, when the bend assembly 7700 is inserted into the ring member 7900, the leading edge of the tubular end 7713 of the bend assembly 7710 forms a surface seal with the sealing member 7950. For example, the leading edge of the tubular end 7713 deforms the sealing member 7950 to form a seal. This engagement minimizes surface area contact to reduce friction, thereby allowing a seal to be formed between the components while allowing the bend assembly to rotate freely relative to the ring member. When the sealing member is elastic, it elastically returns to its original cantilever position when the bend assembly is removed from the ring member.

[0255] In addition, the first end 7712 of the bend member 7710 includes a radially outwardly extending ridge 7722, which serves as a stop to prevent the bend assembly 7700 from being over-inserted into the ring member 7900.

[0256] In the example shown, the sealing groove 7905 is located adjacent to the first side, i.e., adjacent to the first flange 7915 adapted to be located in the inner side of the intermediate guide portion 6352 of the headband 6300, and is disposed to the inner periphery or hole of the ring member 7900. The sealing groove 7905 is arranged to receive the sealing member 7950 and secure the sealing member 7950 in the operating position (see, for example, [reference needed]). Figure 13 ).

[0257] In the example shown (see, for example) Figure 13 In this embodiment, the sealing member 7950 includes a generally L-shaped connecting portion 7952 and a radial sealing portion 7954 (e.g., a cylindrical, flexible flange, or radial lip seal) projecting radially inward from the connecting portion 7952. As shown, the sealing groove 7905 is generally L-shaped to receive the L-shaped connecting portion 7952. In the example, the sealing member 7950 may be coupled or overmolded onto the ring member 7900.

[0258] In one example, such as Figure 13 As shown, the tapered portion 7907 can be disposed adjacent to the recess 7905 in the bore of the ring member 7900, for example, the tapered portion reduces the bore diameter from the sealing groove to the main inner diameter of the bore. In one example, the tapered portion 7907 can be configured and arranged to allow the radial sealing portion 7954 of the sealing member 7950 to cantilever radially inward without minimum contact on either side of the radial sealing portion.

[0259] Decoupling arrangement

[0260] Connector assembly 7600 provides decoupling of air circuit 4170 from patient interface, for example, to enhance decoupling of tube resistance on patient interface, thereby preventing seal instability.

[0261] A decoupling mechanism is provided by clamping arm 7740, which forms a pivot connection that allows the bend assembly 7700 to rotate freely 360° relative to the ring member 7900. Another form of decoupling is provided by pivot connector 7790, which allows pivot connector 7790 (and the air circuit 4170 connected to pivot connector 7790) to rotate freely 360° relative to the bend member 7710.

[0262] The tubular end 7713 at the first end of the bent tube member 7710 may have a textured surface finish. This textured surface finish helps prevent squealing when the bent tube member rotates within the ring member during use. Additionally, the textured surface finish reduces the torque required to rotate the bent tube member within the ring member, i.e., it smooths the rotation. This arrangement reduces, for example, the force / torque applied to the headband by the air circuit 4170 (tube drag) when the patient moves.

[0263] The outer surface of the ring member 7900, especially the outer surface of the snap-fit ​​part 7750 that contacts the bend assembly and disassembly of the ring member, may also have a textured surface finish, for example, to reduce friction and thus facilitate assembly / disassembly.

[0264] Low profile clamping components

[0265] In the example shown, clamping member 7730 has a low profile, for example, the clamping member is received in a recess of the bend member such that one or more portions of the clamping member are only slightly raised above the outer surface of the recess surrounding the bend member.

[0266] For example, such as Figure 9 As shown, the clamping member 7730 is received in the recess 7715 of the bent tube member 7710, such that the button portion 7780 is only slightly outside the outer surface surrounding the recess 7715.

[0267] As described above, the latching portion 7750 is arranged to pivot on a corresponding lug 7716 on the bent pipe member 7710. The lug 7716 is disposed within a corresponding side recess 7715S of the bent pipe member 7710, and therefore the total length of the lug extending outward from the bent pipe member (i.e., extending outward beyond the outer surface surrounding the side recess) is shorter than if the lug were disposed on a non-recessed surface of the bent pipe member. In addition, each latching portion 7750 includes a recess 7757 to receive the corresponding lug 7716, which further reduces the outward extent of the clamping member 7730 when the clamping member is attached to the bent pipe member 7710.

[0268] In one example, in order to form a side recess 7715S in the bend member 7710, the sidewall of each side recess 7715S extends inward from the outer sidewall of the bend member 7710 that defines the outer surface, rather than cutting off the material of the sidewall of the bend member (i.e., thinning the outer sidewall to form the recess). Figure 8 The wall of the side recess 7715S is shown, which extends inward from the outer wall of the bend member 7710 and enters the flow path defined by the bend member 7710.

[0269] In one example, the side recess 7715S and the clamping member 7730 are configured and arranged such that the outer surface of the button portion 7780 is not completely flush with the outer surface of the curved member 7710, for example, to provide a slight protrusion for the patient (e.g., as shown in the image). Figure 9 The button section 7780 used (as shown)

[0270] In one example, the low-profile button portion 7780 is less likely to grab a patient's hair and become tangled during use. The connecting portion 7760 of the clamping member 7730 is also recessed within the upper recess 7715U (see, for example, [reference]). Figure 11), and therefore is unlikely to tangle in the patient's hair during use.

[0271] In one example, such as Figure 26 As shown, the side recess 7715S can also be used as a "stop" to prevent the button part 7780 from moving or deflecting excessively inward during use, thereby enhancing durability.

[0272] Alternative examples

[0273] It should be understood that many aspects of this technology can be used with other suitable connector arrangements.

[0274] For example, the connector assembly may not include a bend in the air circuit connection to the patient interface. In alternative examples, aspects of the clamping member may be applied to other connector arrangements, such as the end of the air circuit (short or long tube) where the air circuit is coaxial with the connector.

[0275] In alternative examples, the connector assembly can be adapted for use with other suitable interface arrangements, such as full-face mask systems or nasal mask systems. In the case of a full-face mask system, the connector assembly may include an AAV (Automatic Animation Assist).

[0276] In the example shown, the bend assembly includes a vent. In an alternative example, if a vent is provided elsewhere in the system, the bend assembly may not include a vent.

[0277] In alternative examples, clamping members and bends can be integrally formed as a single-piece structure. For example, Figure 31 An example of a pipe bending assembly 8700 including an integral clamping member 8730 and a pipe bending member 8710 is shown. In this example, the snap fastener of the clamping member 8730 can be disposed to a corresponding snap fastener portion 8750 as described above, and / or one or more snap fasteners can be disposed to a connecting portion 8760 connecting the snap fastener portion.

[0278] 5.3.1 Sealing Formation Structure

[0279] 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—can vary from day to day and from patient to patient within a given treatment course, 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.

[0280] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0281] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material such as silicone rubber.

[0282] The sealing structure 3100 according to this technology can be made of a soft, flexible, elastic material such as silicone.

[0283] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each sealing formation structure being configured to correspond to a different size and / or shape range. For example, the system may include one type of sealing formation structure 3100 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.

[0284] 5.3.1.1 Sealing Mechanism

[0285] 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 positive pressure of the system acting within the inflation chamber 3200 on its underside, thereby forming a tight, sealed engagement with the face. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0286] 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 around at least a portion of the periphery. The support flange is or includes a spring-like element and serves to support the sealing flange against buckling during use.

[0287] In one form, the sealing structure may include a compression seal or a gasket seal. In use, the compression seal or gasket seal is constructed and arranged to be compressed, for example, due to elastic tension in the positioning and stabilizing structure.

[0288] In one form, the seal forming structure includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by adjacent areas of the sealing flange.

[0289] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0290] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tensioning portion, and a portion having an adhesive or bonding surface.

[0291] 5.3.1.2 Nasal bridge or nasal ridge area

[0292] In one form, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the nose or bridge of the nose or ridge of the nose region of the patient's face during use.

[0293] In one form, the sealing structure includes a saddle-shaped region configured to form a seal on the bridge of the nose or nasal region of a patient's face during use.

[0294] 5.3.1.3 Upper lip area

[0295] In one form, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the upper lip region (i.e., the upper part of the lip) of the patient's face during use.

[0296] In one form, the sealing-forming structure includes a saddle-shaped area configured to form a seal on the upper lip region of a patient's face during use.

[0297] 5.3.1.4 Chin area

[0298] In one form, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the chin area of ​​the patient's face during use.

[0299] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the chin area of ​​a patient's face during use.

[0300] 5.3.1.5 Forehead area

[0301] 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.

[0302] 5.3.1.6 Nasal pillow

[0303] In one embodiment, 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.

[0304] 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 bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Furthermore, the nasal pillow-connecting structure of the present invention includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of displacement and angle between the truncated cone and the nasal pillow-connecting structure. For example, the position of the truncated cone can be axially moved toward the handle-connecting structure.

[0305] 5.3.2 Inflation Chamber

[0306] The air chamber 3200 has a periphery shaped to complement the surface contours of a normal person's face in an area that will form a seal during use. In use, the edges of the air chamber 3200 are positioned adjacent to this surface. The sealing structure 3100 provides actual contact with the face. The sealing structure 3100 can extend around the entire periphery of the air chamber 3200 during use. In some forms, both the air chamber 3200 and the sealing structure 3100 are formed from a single homogeneous material.

[0307] 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 tends to be less obtrusive and / or more comfortable for the wearer, which can improve treatment adherence.

[0308] 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 prominence of the patient interface and helps improve treatment adherence. Using a transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0309] In some forms of this technology, the air chamber 3200 is made of a transparent material. Using a translucent material can reduce the protrusion of the patient interface and help improve treatment adherence.

[0310] 5.3.3 Positioning and Stabilization Structure

[0311] The sealing structure 3100 of the patient interface 3000 of this technology can be kept in a sealed state during use by positioning and stabilizing structure 3300.

[0312] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure in the inflation chamber 3200 to lift the face away.

[0313] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the effects of gravity on the patient interface 3000.

[0314] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0315] In one form of this technology, a positioning and stabilization structure 3300 is provided, constructed in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilization structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. 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.

[0316] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a supine sleeping position, wherein the back area of ​​the patient's head is on a pillow.

[0317] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying in a side-sleeping position, wherein the lateral area of ​​the patient's head is on the pillow.

[0318] In one embodiment 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. This decoupling portion does not resist compression and may be, for example, a flexible or soft bandage. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, its presence prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0319] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a band constructed from a laminate of 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 band. In another embodiment, the fabric outer layer includes a loop material for engaging with a hook material portion.

[0320] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For example, the strap may be configured to be tensioned during use and to guide forces to bring 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.

[0321] In one form of the technology, the positioning and stabilizing structure includes a first frenulum, which is configured and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the supraaural base of the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0322] In one form of the technology applicable to nasal masks or 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 the upper edge of the second strap passes below the subauricular base of the patient's head and covers or is located below the occipital bone of the patient's head.

[0323] In one form of this technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap that is configured and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.

[0324] In some forms of this technology, the positioning and stabilizing structure 3300 includes straps that are flexible and, for example, non-rigid. An advantage of this is that the straps make it more comfortable for the patient to lie on them while sleeping.

[0325] In some forms of this technology, the positioning and stabilizing structure 3300 includes a belt configured to be breathable to allow moisture to be transported through the belt.

[0326] In some forms of this technology, a system is provided comprising more than one positioning and stabilizing structure 3300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0327] 5.3.4 Vent

[0328] In one form, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0329] In some configurations, the airway 3400 is configured to allow continuous ventilation flow from the interior of the inflation chamber 3200 to the surrounding environment, while the pressure within the inflation chamber is positive relative to the surrounding environment. The airway 3400 is configured such that the airway flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the therapeutic pressure within the inflation chamber during use.

[0330] 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.

[0331] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a decoupling structure (e.g., a rotating shaft).

[0332] 5.3.5 Decoupling Structure

[0333] In one form, the patient interface 3000 includes at least one decoupling structure, such as a pivot or ball and socket.

[0334] 5.3.6 Connection Port

[0335] Connection port 3600 allows connection to air circuit 4170.

[0336] 5.3.7 Forehead Stent

[0337] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0338] 5.3.8 Anti-suffocation valve

[0339] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0340] Port 5.3.9

[0341] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to a 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.

[0342] 5.4 Glossary

[0343] For 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.

[0344] 5.4.1 General Concepts

[0345] Air: In some forms of this technology, air may be considered to refer to atmospheric air, and in other forms of this technology, air may be considered to refer to some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0346] Environment: In some forms of this technology, the term “environment” refers to (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0347] For example, the environment relative to a humidifier humidity This could be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's bedroom. This ambient humidity can differ from the humidity outside the patient's bedroom.

[0348] In another example, environmental stress can be stress that is directly around the body or outside the body.

[0349] 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 from the mask or patient interface. Ambient noise can be generated by sources outside the room.

[0350] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjustable, for example, from one breath to another, between minimum and maximum, depending on the presence or absence of an SDB event indication.

[0351] Continuous positive airway pressure (CPAP) therapy: respiratory pressure therapy in which the treatment pressure remains substantially 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 the patient's 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.

[0352] Flow velocity: 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 a scalar quantity, i.e., a quantity that has only magnitude. In other cases, the reference to flow rate will be a vector quantity, i.e., a quantity that has both magnitude and direction. Flow velocity can be represented by the symbol Q. "Flow velocity" is sometimes simplified to simply "flow" or "airflow".

[0353] In the example of patient breathing, the 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 airflow exiting the RPT device. Tidal flow rate Qv is the airflow exiting 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 airflow received into the patient's respiratory system.

[0354] Humidifier: The term humidifier will be considered to refer to a humidifying 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 the patient’s medical respiratory condition.

[0355] Leakage: The term "leakage" will be considered as an unintended flow of air. In one example, a leak might occur due to an incomplete seal between the mask and the patient's face. In another example, a leak could occur in a bend in the conduit leading to the surrounding environment.

[0356] Noise, conducted (acoustic): In this document, conducted noise refers to noise delivered to the patient through pneumatic pathways, such as air circuits and patient interfaces, 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.

[0357] Noise, Radiation (Acoustic): Radiated noise in this document refers to noise carried to the patient by ambient air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object under discussion according to ISO 3744.

[0358] Noise, ventilation (acoustic): Ventilation noise in this document refers to the noise generated by the flow of air through any ventilation opening (such as the ventilation hole of a patient interface).

[0359] Patient: A person, whether or not they have a respiratory disorder.

[0360] Pressure: Force per unit area. Pressure can be expressed in units, including cmH2O and gf / cm². 2 And 1000 pascals. 1 cmH2O equals 1 g-f / cm 2 2, approximately 0.98 hectopascals. In this specification, unless otherwise stated, pressure is given in cmH2O.

[0361] The pressure in the patient interface is assigned the symbol Pm, while the treatment pressure, representing the target value achieved by the mask pressure Pm at the current moment, is assigned the symbol Pt.

[0362] Respiratory pressure therapy (RPT): Applying an air supply to the airway inlet at a treatment pressure that is normally positive relative to the atmosphere.

[0363] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0364] 5.4.1.1 Materials

[0365] Silicone or silicone elastomer: Synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. 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.

[0366] Polycarbonate: a transparent thermoplastic polymer of bisphenol A carbonate.

[0367] 5.4.1.2 Mechanical Properties

[0368] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0369] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain siloxanes and thermoplastic elastomers.

[0370] Hardness: The ability of a material to resist deformation (e.g., described by Young's modulus or by an indentation hardness scale measured on a standardized sample size).

[0371] "Soft" materials can include silicone resins or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0372] "Hard" materials can include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0373] 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. The structure or component can provide different resistance in different directions.

[0374] Flexible structures or components: structures or components that will change shape (e.g., bend) when subjected to a relatively short period of time, such as 1 second, to support their own weight.

[0375] Rigid structures or components: Structures or components that do not substantially change shape when subjected to the loads typically encountered in use. An example of such use could be, for instance, setting and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway at a pressure of approximately 20 to 30 cmH2O.

[0376] As an example, an I-beam may contain a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component may be flexible in the first direction and rigid in the second direction.

[0377] 5.4.2 Respiratory and Circulatory Systems

[0378] Apnea: According to some definitions, apnea is considered to have occurred when airflow is below a predetermined threshold for a sustained period of time, such as 10 seconds. Obstructive apnea is considered to have occurred when, despite the patient's efforts, some obstruction of the airway prevents airflow. Central apnea is considered to have occurred when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to have occurred when reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0379] Respiratory rate: Usually measured as the rate of spontaneous breathing of a patient per minute.

[0380] Duty cycle: The ratio of inhalation time Ti to total respiratory time Ttot.

[0381] Effort (breathing): This is the work done by a person who is trying to breathe voluntarily.

[0382] The expiratory phase of the respiratory cycle: the time period from the start of expiratory flow rate to the start of inspiratory flow rate.

[0383] Flow limitation: Flow limitation is considered an event state in a patient's breathing where an increase in the patient's effort does not result in a corresponding increase in flow. When flow limitation occurs during the inspiratory phase of the respiratory cycle, it can be described as inspiratory flow limitation. When flow limitation occurs during the expiratory phase of the respiratory cycle, it can be described as expiratory flow limitation.

[0384] Flow-limited inhalation waveform type:

[0385] (i) Flattening: It has an ascending part, followed by a relatively flat part, and then a descending part.

[0386] (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.

[0387] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.

[0388] (iv) Inverted chair type: has a relatively flat section, followed by a single local peak at the trailing edge.

[0389] Insufficient breathing: By some definitions, insufficient breathing is considered a reduction in flow, rather than a cessation of flow. In one form, insufficient breathing can be said to have occurred when the flow rate is below a threshold rate for a period of time. Central insufficient breathing is considered to have occurred when insufficient breathing is detected due to reduced respiratory effort. In one form in adults, any of the following can be considered insufficient breathing:

[0390] (i) The patient’s respiratory rate decreases by 30% for at least 10 seconds plus a related 4% desaturation; or

[0391] (ii) The patient’s breathing decreases (but less than 50%) for at least 10 seconds, accompanied by at least 3% of related desaturation or arousal.

[0392] Hyperventilation: The flow rate increases to above normal levels.

[0393] The inspiratory phase of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory phase of the respiratory cycle.

[0394] Patentity (airway): The degree to which the airway is open, or the extent to which the airway is open. The patient's airway is open. Airway patentness can be quantified, for example, a value of one (1) is patent, and a value of 0 is closed (obstructed).

[0395] Positive end-expiratory pressure (PEEP): The pressure above the atmosphere in the lungs at the end of expiration.

[0396] Peak flow rate (Qpeak): The maximum flow rate during the inspiratory phase of this respiratory flow waveform.

[0397] Respiratory flow rate, patient airflow rate, respiratory airflow rate (Qr): These terms can be understood as estimates of the respiratory flow rate of the RPT device, as opposed to “true respiratory flow rate” or “real respiratory rate”, which is the actual respiratory flow rate experienced by the patient, usually expressed in liters per minute.

[0398] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, the inspiratory volume Vi (the volume of air inhaled) equals the expiratory volume Ve (the volume of air exhaled), therefore a single tidal volume Vt can be defined as equal to either volume. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, such as an average.

[0399] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0400] (Exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0401] Total Time (Ttot): The total duration between the start of one inspiratory phase of a respiratory flow waveform and the start of the next inspiratory phase of the same waveform.

[0402] Typical recent ventilation: The most recent value of ventilation at a given time scale tends to cluster around the ventilation values; that is, it is a measure of the central tendency of the most recent values ​​of ventilation.

[0403] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This can be associated with a flow-limiting state in which the flow rate increases only slightly, or even decreases with an increase in the pressure differential across the upper airway (Starling resistor behavior).

[0404] Ventilation (air ventilator): A measure of the rate at which a patient's respiratory system exchanges gases. Ventilation volume can include one or both of the inspiratory and expiratory flow rates per unit time. When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply expressed as volume and understood as volume per minute.

[0405] 5.4.3 Ventilation

[0406] Adaptive Servo Ventilator (ASV): A servo ventilator with a variable rather than a fixed target ventilation. The variable target ventilation can be learned from some characteristics of the patient, such as the patient's breathing characteristics.

[0407] Backup rate: A ventilator parameter that determines the minimum rate of breathing (usually expressed as breaths per minute) that the ventilator will deliver to the patient if it is not triggered by spontaneous breathing effort.

[0408] Cycle: The termination of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, the ventilator is said to cycle to stop delivering breaths at the end of the inspiratory phase of the respiratory cycle.

[0409] Positive Expiratory Airway Pressure (EPAP): Baseline pressure, the pressure that changes during breathing is increased to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0410] End-expiratory pressure (EEP): The desired mask pressure that the ventilator will attempt to achieve at the end of the expiratory phase of breathing. If the pressure waveform template Π(Φ) is zero at the end of expiration, i.e., Π(Φ) = 0, then Φ = 1, and EEP equals EPAP.

[0411] Inspiratory positive airway pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory phase of breathing.

[0412] Pressure support: Indicates that the pressure increase during inspiration exceeds the pressure increase during expiration, and typically represents the pressure difference between the maximum inspiratory pressure and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support implies a difference the ventilator aims to achieve, rather than a difference it actually achieves.

[0413] Servo ventilator: A ventilator that measures patient ventilation with a target ventilation volume and adjusts the pressure support level to bring the patient's ventilation volume to the target ventilation volume.

[0414] Spontaneous / Timed (S / T): The mode of a ventilator or other device that attempts to detect the onset of spontaneous breathing in a patient. However, if the device cannot detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.

[0415] Swaying: A term equivalent to pressure support.

[0416] Trigger: When a ventilator delivers breathing air to a patient who is breathing spontaneously, it is said to be triggered by the patient's effort at the beginning of the respiratory cycle.

[0417] 5.4.4 Anatomy

[0418] 5.4.4.1 Facial Anatomy

[0419] Alar: The outer wall or "wing" of each nostril (plural: alar)

[0420] Nasal alar angle:

[0421] Alar tip: the outermost point on the ala of the nose.

[0422] Nasal wing curve (or nasal apex) point: The point at the very end of the curve baseline of each nasal wing, found in the crease formed by the junction of the nasal wing and the cheek.

[0423] Auricle: The entire visible external part of the ear.

[0424] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nose of the frontal bone.

[0425] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0426] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0427] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (the two lines intersect at the lower point of the nasal septum).

[0428] Frankfurt plane: A line extending from the lowest point of the eye socket margin to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0429] The glabella (between the eyebrows): Located on the soft tissue, it is the most prominent point in the sagittal plane at the midline of the forehead.

[0430] Cartilage: a cartilaginous plate that is basically triangular in shape. 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.

[0431] Lips, lower part (lower lip):

[0432] Lips, upper part (upper lip):

[0433] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four smaller cartilages.

[0434] Nostrils: Generally oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils is nasal opening (nostril). Nostrils are separated by the nasal septum.

[0435] 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.

[0436] Nasolabial angle: the angle between the columella and the upper lip, which intersects with the lower side of the nose.

[0437] Inferior auricular base: the lowest point where the auricle attaches to the facial skin.

[0438] Upper auricular base: the highest point where the auricle attaches to the facial skin.

[0439] 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.

[0440] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0441] Prechin point: Located on the soft tissue, at the midpoint of the front part of the chin.

[0442] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0443] Sagittal plane: A vertical plane running from front to back. The midsagittal plane is the sagittal plane that divides the body into the right and left halves.

[0444] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0445] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0446] Posterosuperior lateral lamina: the point at the lower edge of the base of the nasal ala, where the base of the nasal ala joins the skin of the upper (superior) lip.

[0447] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0448] Nasal ridge: the point of greatest indentation between the midline of the lower lip and the soft tissue ridge.

[0449] 5.4.4.2 Anatomical Structure of the Skull

[0450] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0451] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0452] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw and below the orbit. The frontal process of the maxilla projects laterally upward from the nose and forms part of the lateral boundary.

[0453] Nasal bones: The nasal bones are two small rectangular bones that vary in size and shape from individual to individual; they are placed side by side in the middle and upper part of the face and form the "bridge" of the nose through their joint.

[0454] Nasal root: The part where the frontal bone and the two nasal bones intersect, located directly between the eyes and in the concave area on the upper part of the bridge of the nose.

[0455] 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.

[0456] The eye socket is the bony cavity in the skull that houses the eyeball.

[0457] Parietal bone: The parietal bone is the top and sides of the skull when joined together.

[0458] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face called the temple.

[0459] Cheekbones: The face consists of two cheekbones, which are located on the upper and side of the face and form the prominent part of the cheek.

[0460] 5.4.4.3 Anatomy of the Respiratory System

[0461] 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.

[0462] The larynx is a vocal cord or larynx that houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0463] Lungs: The human respiratory organs. The trachea of ​​the lungs include the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory tract includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0464] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal, outwardly extending portions called nasal conchae (single "external ears") or nasal turbinate bones. The anterior part of the nasal cavity is the nose, while the posterior part merges into the nasopharynx through the nostrils.

[0465] 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 oropharynx (middle pharynx), and the laryngopharynx (hypopharynx).

[0466] 5.4.5 Patient Interface

[0467] Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0468] Bend: A bend is an example of a structure that directs the axis of an airflow traveling through it 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 removable from the mating component, for example, via a snap-fit ​​connection. In some forms, the bend can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0469] Frame: The frame is generally considered to refer to the mask structure that bears the tensile load between two or more connection points with the headband. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0470] Functional dead space:

[0471] Headband: A headband is considered to refer to a form of positioning and stabilization structure designed for use on the head. For example, a headband may include an assembly of one or more support bars, 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 laminated composites of soft, flexible, elastic materials such as foam and fabric.

[0472] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0473] Inflation chamber: The mask inflation chamber is considered to refer to the portion of the patient interface having walls that at least partially enclose a volume of space, which, during use, contains air pressurized therein to above atmospheric pressure. An outer shell may form part of the wall of the mask inflation chamber.

[0474] Sealing: can refer to the noun form of a structure (sealant) or the verb form of the effect (seal). Two elements can be constructed and / or arranged to 'seal' or to achieve 'sealing' between them, without the need for a separate 'sealing' element itself.

[0475] Shell: The shell is considered to be a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural wall of a face mask can be a shell. In some forms, the shell may have facets. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0476] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0477] Support: The support will be considered as a structural component designed to increase the compressibility of another component in at least one direction.

[0478] Rotary shaft (noun: a sub-component of a part 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 context of air delivery ducts, the sub-assembly of the part preferably comprises a pair of mating cylindrical pipes. During use, there may be little or no airflow leakage from the rotary shaft.)

[0479] Lacing (noun: a structure used to resist tension).

[0480] Ventilation port: (noun): A structure that allows airflow from inside the mask or tubing to ambient air, for example, to effectively flush out exhaled gases. For example, clinically effective flushing can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute, depending on the mask design and treatment pressure.

[0481] 5.4.6 Shape of the structure

[0482] Products according to this technology may include one or more three-dimensional mechanical structures, such as mask pads or thrusters. The three-dimensional structure may be defined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe associated surface orientation, location, function, or some other characteristic. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, the sealing-forming structure may include a surface-contacting (e.g., outer) surface and separate non-surface-contacting (e.g., underside or inner) surfaces. In another example, the structure may include a first surface and a second surface.

[0483] To aid in describing the shape of three-dimensional structures and surfaces, we first consider a cross-section through a point p on the surface of the structure, see [reference needed]. 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 examples, the surface is depicted from the viewpoint of an imaginary little person standing upright on the surface.

[0484] 5.4.6.1 Curvature in one dimension

[0485] The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and a quantity (e.g., the reciprocal of the radius of the circle that only touches the curve at p).

[0486] Positive curvature: If the curve at point p turns outward toward the normal, then the curvature at that point will be positive (if the figures in the image were to leave point p, they would have to walk uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to relatively small positive curvature). Such curves are often referred to as concave surfaces.

[0487] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if you imagine a little person leaving point p, they can walk horizontally without going up or down). See also Figure 3D .

[0488] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if you imagine little figures leaving point p, they must go downhill). See also Figure 3E (and Figure 3F Compared to relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to relatively large negative curvature). Such curves are often referred to as convex surfaces.

[0489] 5.4.6.2 Curvature of Two-Dimensional Surfaces

[0490] A description of the shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. These cross sections may cut through 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 quantity, for example, a relatively small quantity. Figures 3B to 3F A planar curve in a diagram can be an example of multiple cross-sections at a specific point.

[0491] Principal curvature and principal direction: The direction of the normal plane to which the curvature of the curve reaches its maximum and minimum values ​​is called the principal direction. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, and the minimum value appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross-section along the principal direction. The principal curvature at p is the curvature along the principal direction.

[0492] A region of a surface: a connected set of points on the surface. This set of points in a region can have similar characteristics, such as curvature or sign.

[0493] Saddle-shaped region: a region in which the principal curvature has opposite signs at each point, i.e., one sign is positive and the other sign is negative (which may be going up or down depending on the direction the imagined individual is turning).

[0494] Dome region: A region in which the principal curvature has the same sign at each point, such as two positive ("concave dome") or two negative ("convex dome").

[0495] 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.

[0496] Planar region: A surface region in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0497] Surface edge: The boundary or limit of a surface or region.

[0498] Path: In some forms of this technique, 'path' will be considered to mean a path in a mathematical-topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, 'path' can be described as a route or process, including, for example, a set of points on a surface. (Imagined individual paths are those in which they walk on a surface and resemble garden paths).

[0499] Path length: In some forms of this technique, 'path length' will be considered as the distance along the surface from f(0) to f(1), i.e., the distance along a 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 imagined individual would be the distance they travel along the path on the surface).

[0500] 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, a path with the same length as the straight-line distance between two points on the surface can exist on the surface. In a non-planar surface, a path with the same length as the straight-line distance between two points may not exist. (For an imaginary individual, straight-line distance will correspond to the distance as a 'straight line'.)

[0501] 5.4.6.3 Space Curves

[0502] Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, that is, without endpoints. A space curve can be thought of as a one-dimensional segment of three-dimensional space. An imaginary human walking along one strand of a DNA helix travels along a space curve. 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 contains 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. Typically, a space curve can be described by the curvature and torsion at each point on the curve. Torque is a measure of how the curve deviates from the plane. Torque has a sign and magnitude. The torsion at a point on a space curve can be characterized by reference to the tangent vector, normal vector, and double normal vector at that point.

[0503] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. The tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If a hypothetical person were flying along the curve and falling from their aircraft at a specific point, the direction of the tangent vector would be the direction they would have traveled.

[0504] Unit normal vector: This is the vector that changes as an imaginary person moves along the curve. The unit vector pointing in the direction of the change of the tangent vector is called the principal normal vector. It is perpendicular to the tangent vector.

[0505] A double-normal unit vector is a vector that 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, [link to relevant documentation]). Figure 3P ) or optionally by left-hand rule ( Figure 3O To determine.

[0506] Oscillating plane: The plane containing the unit tangent vector and the unit principal normal vector. See appendix. Figure 3O and 3P .

[0507] Torque of a space curve: The torsion of a space curve at a point is the magnitude of the rate of change of the unit vector of the binormal at that point. It measures the degree to which the curve deviates from the osculating plane. A space curve lying in the plane has zero torsion. A space curve deviating relatively small from the osculating plane will have a relatively small torsion (e.g., a gently sloping spiral path). A space curve deviating relatively large from the osculating plane will have a relatively large torsion (e.g., a sharply sloping spiral path). See also Figure 3S Since T2 > T1, therefore Figure 3S The amount of twist near the top coil of the spiral is greater than Figure 3S The amount of twist of the bottom coil of the spiral.

[0508] Reference Figure 3P According to the right-hand rule, a space curve oriented towards the right-hand binormal direction can be considered to have a right-hand positive twist (e.g., Figure 3S (The right-handed spiral shown in the image). A spatial curve that turns away from the direction of the right-hand double normal can be considered to have a right-handed negative twist (e.g., a left-handed spiral).

[0509] Similarly, refer to the left-hand rule (see...) Figure 3O A space curve oriented towards the left-hand double normal direction can be considered to have a left-hand positive twist (e.g., a left-hand spiral). Therefore, left-hand positive is equivalent to right-hand negative. See also Figure 3T .

[0510] 5.4.6.4 holes

[0511] 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, [example missing]. Figure 3I The structure shown has a one-dimensional hole in a surface bounded by a planar curve.

[0512] 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 bladder having cavities for air or gel can have two-dimensional pores. See, for example, [link to relevant documentation]. Figure 3L The pad and through Figure 3M and Figure 3N An exemplary cross-section is shown, illustrating the inner surface defining a two-dimensional aperture. In yet another example, the conduit may include a one-dimensional aperture (e.g., at its inlet or outlet) and a two-dimensional aperture defined by the conduit's inner surface. See also Figure 3K The two-dimensional hole in the structure shown is defined by the surface shown.

[0513] 5.5 Other Remarks

[0514] 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 such value or intermediate value within the range are broadly included within this technique. The upper and lower limits of these intermediate ranges may be included independently within the intermediate range and within the scope of this technique, but are subject to any explicitly excluded boundaries within the range. Where the range includes one or both of the extreme values, this technique also includes ranges that exclude any one or both of those included extreme values.

[0515] Furthermore, where one or more values ​​described herein are implemented as part of this technique, it should be understood that such values ​​may be approximate unless otherwise stated, and such values ​​may be used to the extent permitted or required by the practical implementation of the technique for any appropriate valid digits.

[0516] 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 invention pertains. Although any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this technology, a limited number of representative methods and materials are described herein.

[0517] When a particular material is identified for use in constructing a component, a clearly alternative material with similar properties is used as its substitute. Furthermore, unless otherwise specified, all components herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0518] It must be noted that, unless the context clearly specifies otherwise, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents.

[0519] All publications mentioned herein are incorporated herein in their entirety by reference to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided only for those published prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology is not entitled to priority of these publications due to prior invention. Furthermore, the publication dates provided may differ from the actual publication dates and may require separate verification.

[0520] The terms “comprises” and “comprising” should be understood as referring to individual elements, components or steps in a non-exclusive manner, indicating the marked elements, components or steps that may be present or utilized, or combinations thereof with other unmarked elements, components or steps.

[0521] The headings used in the detailed description are for the convenience of the reader only and should not be used to limit the subject matter found in this disclosure or throughout the claims. The headings should not be used to interpret the scope of the claims or to limit the claims.

[0522] Although the present technology has been described herein with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present technology. In some cases, terms and symbols may imply specific details not required for the practice of the present technology. For example, although the terms "first" and "second" may be used, unless otherwise stated, they are not intended to indicate any order, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in a certain order, this order is not necessary. Those skilled in the art will recognize that this order can be modified, and / or aspects of the order may be performed simultaneously or even concurrently.

[0523] Therefore, it should be understood that numerous modifications can be made to this exemplary embodiment, and that other arrangements can be designed without departing from the spirit and scope of the present technology.

[0524] 5.6 List of Reference Symbols

[0525] Feature Item Number Patient 1000 Bedside Companion 1100 Patient Interface 3000 Non-invasive Patient Interface 3000 Sealing Forming Structure 3100 Inflation Chamber 3200 Positioning and Stabilizing Structure 3300 Ventilation Port 3400 Connection Port 3600 Forehead Support 3700 RPT Device 4000 Air Circuit 4170 Humidifier 5000 Patient Interface 6000 Sealing Forming Structure 6100 Buffer Assembly 6150 Inflation Chamber 6200 Headband 6300 Back Headband Strap 6310 Tube 6350 Intermediate Catheter Section 6352 Lip 6354 Orifice 6355 Adjustment Mechanism 6360 Telescopic Tube Section 6362 Connection Port 6600 Connector Assembly 7600 Bend Assembly 7700 Bend Component 7710 First End 7712 Tubular End 7713 Second End 7714 Recess 7715 Lateral Recess 7715 7715 S-shaped recess 7716 U-shaped lug 7716 tubular end 7717 channel 7717 C-shaped stop 7719 vent 7720 ridge 7722 flange 7722 shelf 7723 clamping member 7730 clamping arm 7740 clamping arm 7740 snap fastener 7750 snap fastener 7755 snap fastener 7755 recess 7757 connecting part 7760 button part 7780 finger grip part 7781 rotating shaft connector 7790 Protrusion 7795 Ring Member 7900 Sealing Groove 7905 Cone 7907 First Side 7910 First Flange 7915 Second Side 7920 Second Flange 7925 Channel 7930 Clamping Flange 7940 Ramp 7941 Clamping Channel 7945 Sealing Member 7950 Connecting Part 7952 Sealing Part 7954 Bending Assembly 8700 Bending Member 8710 Clamping Member 8730 Connecting Part 8760

Claims

1. A bend assembly for a patient interface, the bend assembly comprising: A bend in the pipe, the bend in the pipe including an outer surface disposed outside the airflow path formed by the bend in the pipe; and A clamping member disposed on the bend member, wherein the clamping member includes a structure separate from and distinct from the bend member. The bent tube member and the clamping member include separate molded parts that are subsequently connected to each other. The outer surface of the bent pipe member includes a recess, which is configured and arranged to receive at least a portion of the clamping member. The clamping member is configured and arranged to releasably connect the bend assembly to the patient interface, and The clamping member includes a pair of resilient, quick-release clamping arms configured to form a rotatable connection using a ring member disposed on the patient interface, allowing the bent tube assembly to rotate freely 360° relative to the ring member.

2. The bend assembly of claim 1, further comprising a swivel connector disposed to the bend member, wherein the swivel connector is configured and arranged to releasably connect the bend assembly to an air circuit, and wherein the swivel connector is configured to allow the swivel connector and the air circuit connected thereto to rotate freely 360° relative to the bend assembly.

3. The bend assembly of claim 2, wherein the clamping arm and the swivel connector forming the rotatable connection provide decoupling of the air circuit from the patient interface.

4. The pipe bending assembly according to any one of claims 1 to 3, wherein, The bend assembly is configured and arranged to form a seal with the patient interface when the bend assembly and the patient interface are interconnected.

5. The pipe bending assembly according to any one of claims 1 to 3, wherein the clamping member includes a connecting portion that interconnects the clamping arms.

6. The bend assembly of claim 5, wherein each of the clamping arms includes a snap-fit ​​portion and a button portion, each snap-fit ​​portion including a snap configured to provide a fastener connection assembly for the patient interface.

7. The bend assembly of claim 5, wherein the recess of the bend member includes an upper recess configured to receive the connection portion and a side recess configured to receive a corresponding clamping arm.

8. The bend assembly of claim 7, wherein each of the side recesses includes a lug configured and arranged to interact with a corresponding clamping arm of the clamping arms to retain the clamping member on the bend assembly and to operate the clamping arm.

9. The bend assembly according to any one of claims 1 to 3, wherein the bend member comprises a 90° bend.

10. The bend assembly according to any one of claims 1 to 3, wherein the bend member includes a plurality of vent holes to allow exhaust gas to escape from the patient interface.

11. The bend assembly according to any one of claims 1 to 3, wherein the bend member is made of a material that is more rigid than the material of the clamping member.

12. The bend assembly according to any one of claims 1 to 3, further comprising a retaining arrangement configured to connect the clamping member to the bend assembly.

13. The bend assembly of claim 12, wherein the retaining arrangement comprises a snap-fit ​​connection assembly.

14. The bend assembly according to any one of claims 1 to 3, wherein the clamping member is configured and arranged to provide a separable snap-fit ​​connection assembly with the ring member disposed to the patient interface.

15. The bend assembly of claim 14, wherein the bend member includes a tubular end configured to extend through the annular member and engage with a sealing member to provide a sealed airflow path for delivering pressurized gas through the bend assembly to the patient interface.

16. The bend assembly of claim 14, wherein the clamping member includes a snap configured to engage matingly within a clamping channel formed by the ring member.

17. A patient interface for delivering a flow of air at a positive pressure relative to ambient air pressure to an inlet of a patient's airway during sleep to improve sleep-disordered breathing, said patient airway including at least an inlet in the patient's nostrils, said patient interface comprising: A sealing structure is configured to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway; A positioning and stabilizing structure is configured to provide forces that hold the sealing structure in a therapeutically effective position on the patient's head; as well as The bend assembly according to any one of claims 1 to 3 is configured and arranged to releasably connect the bend assembly to an air circuit.

18. A CPAP system for treating sleep-disordered breathing, the CPAP system comprising: The CPAP unit is configured to supply a positive pressure airflow; The patient interface according to claim 17; and An air circuit is connected between the CPAP device and the patient interface to deliver the positive pressure airflow from the CPAP device to the patient interface.

Images