Medical device connector

Abstract

A headgear connector may include a retainer connectable to a patient interface and including a first engagement structure; and a buckle connectable to a strap of the patient interface and including a second engagement structure. Either the first engagement structure or the second engagement structure may provide a female engagement structure, and the other of the first engagement structure and the second engagement structure may include a male engagement structure. The male engagement structure may include a stem protruding from a surface and a plurality of deflectable pegs protruding from the surface and positioned about the stem. The female engagement structure may include a receptacle defining an opening. The headgear connector is transitionable between an engaged state in which the snap is coupled to the retainer and a disengaged state in which the snap is discoupled from the retainer. In the engaged state, the male engagement structure may be received within the female engagement structure.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of U.S. Provisional Application No. 63 / 487,093, filed February 27, 2023, and U.S. Provisional Application No. 63 / 517,007, filed August 1, 2023, each of which is incorporated herein by reference in its entirety. Background Technology 2.1 Technical Field

[0003] This technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses.

[0004] 2.2 Description of relevant technologies

[0005] 2.2.1 The human respiratory system and its disorders

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

[0007] 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 move from inhaled air into the venous blood and allowing carbon dioxide to move in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually branch into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branches of the airways lead to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is known as the respiratory zone. See John B. West's *Respiratory Physiology*, 9th edition, Lippincott Williams & Wilkins, 2012.

[0008] A range of breathing disorders exist. Some disorders may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0009] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity-related malventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0010] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway closures and a loss of normal muscle tone in the tongue, soft palate, and posterior oropharyngeal regions during sleep. The condition causes affected patients to stop breathing, typically for periods ranging from 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can cause cardiovascular disease and brain damage. This syndrome is a common disorder, particularly among middle-aged overweight men, although affected individuals may not be aware of the problem (see, for example, U.S. Patent No. 4,944,310 (Sullivan)).

[0011] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as the CSR cycle. CSR is characterized by repetitive deoxygenation and reoxygenation of arterial blood. Due to the repetitive oxygen deprivation, CSR can be harmful. In some patients, CSR is associated with repetitive micro-arousals from sleep, which cause severe sleep disruption, increased sympathetic activity, and increased afterload, see, for example, U.S. Patent No. 6,532,959 (Berthon-Jones).

[0012] Respiratory failure is a broad term encompassing respiratory disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can cover some or all of the following disorders.

[0013] Obesity-induced dyspnea syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness in the absence of other known causes of dyspnea. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0014] Neuromuscular disease (NMD) is a broad term encompassing many conditions 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 mobility, wheelchair use, 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 over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0015] Chest wall disorders are a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can lead to severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0016] A range of therapies have been used to treat or improve these conditions. Furthermore, other healthy individuals can utilize these therapies to prevent respiratory distress. However, these therapies have many drawbacks.

[0017] 2.2.2 Treatment

[0018] Various respiratory therapies, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), have been used to treat one or more of the aforementioned respiratory disorders.

[0019] Respiratory pressure therapy is the application of supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy such as canister ventilators or thoracic ventilators).

[0020] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). Its mechanism of action is that CPAP acts as a pneumatic splint and can prevent upper airway obstruction, for example, by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary, and therefore patients may choose not to adhere to the therapy if they find the device used to provide such treatment uncomfortable, difficult to use, expensive, or unsightly.

[0021] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-invasive disease (NMD), and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0022] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively and can be delivered using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0023] 2.2.3 Respiratory Therapy System

[0024] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.

[0025] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.

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

[0027] 2.2.3.1 Patient Interface

[0028] Patient interfaces can be used to attach breathing equipment to its wearer, for example, by providing an airflow into the airway inlet. The airflow can be provided to the patient's nose and / or mouth via a mask, to the patient's mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy to be administered, the patient interface can form a seal with, for example, an area of ​​the patient's face to facilitate the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of about 10 cmH2O relative to ambient pressure). For other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply to the airway at a positive pressure of about 10 cmH2O. For flow-through therapy such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0029] Some 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 due to higher external pressure, but not to maintain internal air at a pressure higher than ambient pressure.

[0030] Some masks may be clinically disadvantageous for this technique, for example, if they block airflow through the nose and only allow airflow through the mouth.

[0031] If some masks require the patient to insert a portion of the mask structure into their mouth to form and maintain a seal through their lips, then such masks may be uncomfortable or impractical for this technology.

[0032] Some face masks may not be very practical to use while sleeping, for example, when the head is resting on a pillow and the person is sleeping on their side in bed.

[0033] Some masks may cause some patients to experience claustrophobia, discomfort, and / or may feel excessively unpleasant.

[0034] The design of the patient interface presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head comprises bones, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during the course of a respiratory therapy session.

[0035] Therefore, some masks have disadvantages such as protrusion, undesirable aesthetics, high cost, poor fit, difficulty in use, and / or discomfort, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized mask can lead to reduced adherence, decreased comfort, and poorer patient outcomes. Masks designed solely for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks used for the administration of anesthetics may be tolerable for their original application; however, such masks can still be undesirably uncomfortable when worn for extended periods (e.g., several hours). This discomfort can lead to decreased patient adherence to therapy, especially when the mask is worn during sleep.

[0036] CPAP therapy is very effective in treating certain breathing disorders, provided the patient adheres to the therapy. Patients may not adhere to the therapy if the mask is uncomfortable or difficult to use. Because patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean their mask, and this can affect patient adherence.

[0037] While masks designed for other applications (such as pilots) may not be suitable for treating sleep-disorder breathing, masks designed for treating sleep-disorder breathing may be suitable for other applications.

[0038] Therefore, designers of patient interfaces may face an almost limitless number of choices. Design criteria may conflict structurally, functionally, and / or with patient-specific conditions (e.g., the presence of certain types of implants), meaning that some design choices are far from conventional or unavoidable. Furthermore, comfort and efficacy in certain aspects may be highly sensitive to minute variations in one or more parameters.

[0039] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0040] 2.2.3.1.1 Sealing Formation Structure

[0041] Patient interfaces may include seal-forming structures. Because the seal-forming structures come into direct contact with the patient's face, their shape and configuration can directly affect the effectiveness and comfort of the patient interface.

[0042] Patient interfaces can be characterized in part by their design intent 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 one 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 another form of patient interface, the sealing structure may include a single element surrounding both the nostril and mouth regions 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.

[0043] For example, due to the different shapes, structures, variable areas, and sensitive areas of a patient's face, a sealing structure that may be effective in one area of ​​a patient's face may not be suitable for use in another area. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0044] Certain seal-forming structures can be designed for mass production, allowing a design to fit comfortably and effectively for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the patient's facial shape and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0045] 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, wherein the seal-forming structure engages face-to-face with the patient's face. The seal-forming structure may include an air- or fluid-filled liner, or a molded or shaped surface of an elastic 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.

[0046] Another type of seal-forming structure includes wing-shaped seals of thin material positioned around the periphery of the mask to provide a self-sealing effect against the patient's face when positive pressure is applied inside the mask. Similar to the previous type of seal-forming section, additional force may be required to achieve a seal if the fit between the face and the mask is poor; otherwise, the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or buckle during use, causing leakage.

[0047] Another type of seal formation may include friction-fitting elements, such as those used for insertion into the nostrils; however, some patients find these seal formations uncomfortable.

[0048] Another form of sealing structure can be achieved using adhesives. Some patients may find it inconvenient to frequently apply and remove adhesives from their face.

[0049] A series of patient interface sealing structure technologies are disclosed in the following patent applications: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0050] One form of nasal pillow was found in the AdamCircuit 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.

[0051] ResMed Inc. has manufactured the following products that include nose pillows: SWIFT TM Nose pillow cover, SWIFT TM II Nose pillow cover, SWIFT TM LT nose pillow cover, SWIFT TM FX nose pillow and MIRAGE LIBERTY TM Full-face mask. The following patent application describes an example of a nose pillow mask: International Patent Application WO 2004 / 073778 (particularly describing SWIFT). TM (Various aspects of the nose pillow cover), US Patent Application 2009 / 0044808 (especially describing SWIFT) TM (All aspects of the LT nose pillow cover); International patent applications WO 2005 / 063328 and WO 2006 / 130903 (particularly describing MIRAGE LIBERTY) TM (All aspects of a full-face mask); International Patent Application WO 2009 / 052560 (especially describing SWIFT) TM (All aspects of the FX nose pillow cover).

[0052] 2.2.3.1.2 Positioning and Stabilizing Structure

[0053] A sealing structure for a patient interface used in positive air pressure therapy is subjected to stress from air pressure that could disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain a seal with appropriate portions of the face. Several factors can be considered when comparing different positioning and stabilization techniques. These include: the effectiveness of the technique in holding the sealing structure in the desired position and sealing it with the face during use of the patient interface; the comfort of the interface for the patient; whether the patient experiences invasiveness and / or claustrophobia while wearing the patient interface; and aesthetic appeal.

[0054] 2.2.3.1.2.1 Adhesives used for positioning and stabilizing structures

[0055] One technique involves using adhesives, see, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0056] 2.2.3.1.2.2 Straps used for positioning and stabilizing structures

[0057] Another technique involves using one or more straps and / or stabilizing straps. Many of these straps suffer from one or more problems, such as poor fit, bulkiness, discomfort, and inconvenience of use.

[0058] 2.2.3.1.2.3 Headgear connector for positioning and stabilizing the structure

[0059] Because of its role in one or more of the following, the headgear connector can enhance the effectiveness of the patient interface: maintaining alignment between the seal-forming structure and the proper seal position; patient comfort, as it may affect the tension applied to the patient's face and the occipital region of the skull due to the influence of the directional component of the strap force; usability, from the perspective of ensuring that the patient can put on the patient interface without effort; ensuring that the patient interface is less likely to fall off or loosen; and overall patient compliance, at least to the extent that this factor depends on patient comfort and usability (whether individually or in combination).

[0060] Many headgear connectors use a pair of magnetic components to secure the headgear (e.g., straps) to form a sealed interface with the patient. However, many patients may find it less than ideal to have the magnets near their face. Furthermore, the use of magnets may not be suitable for some patients who have one or more medical conditions. Additionally, some patients may have impaired sensory abilities to feel and hear the engagement of the magnetic headgear connector.

[0061] On the other hand, some patients may wish to use a magnetic headgear connector in some situations and a non-magnetic headgear connector in others.

[0062] From a manufacturing perspective, magnetic headgear components can be more expensive and harder to obtain compared to non-magnetic headgear options. This may be especially true in situations where there is a global shortage of certain materials. Furthermore, the manufacturing processes involving encapsulating magnets with other medical-grade materials can be more complex, time-consuming, and expensive. All of these factors could hinder the ability of durable medical device providers to offer affordable and accessible patient interface options to a wider range of patients, and especially those with urgent needs, in a timely manner.

[0063] These and other issues can be addressed using the non-magnetic headgear connector options described herein, which effectively secure the seal-forming structure in a manner aligned with the appropriate seal-forming location, providing patient comfort and usability.

[0064] 2.2.3.1.3 Pressurized air duct

[0065] In one type of treatment system, a pressurized airflow is supplied to a patient interface via a conduit in an air circuit. When the patient interface is positioned over the patient's face during use, the air circuit is fluidly connected to the patient interface at a location in front of the patient's face. The conduit can extend forward from the patient interface, away from the patient's face.

[0066] 2.2.3.1.4 Pressurized air ducts used for positioning / stabilizing the sealing structure

[0067] Another treatment system includes a patient interface in which the tubing that delivers pressurized air to the patient's airway also serves as part of a headgear to position and stabilize a sealing portion of the patient interface at the appropriate location on the patient's face. This type of patient interface may be referred to as having a "catheter headgear" or "headgear tube." Such a patient interface allows a catheter in the air circuit providing a flow of pressurized air from a respiratory pressure therapy (RPT) device to be connected to the patient interface at a location other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication No. US2007 / 0246043, the contents of which are incorporated herein by reference, wherein a catheter is connected to the tubing in the patient interface via a port positioned on the top of the patient's head during use.

[0068] The desired outcome is that the patient interface, including the head sleeve, will provide comfort for patients during extended periods of wear while they are asleep, creating an airtight and stable seal against their face, while also accommodating a range of head shapes and sizes.

[0069] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0070] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the various therapies described above, such as by operating the device to generate an airflow for delivery to an interface in the airway. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow-based therapies such as HFT). Therefore, RPT devices can also be used as flow-based therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0071] 2.2.3.3 Air Circuit

[0072] An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system (such as the RPT device and the patient interface) during use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation. In other cases, a single-branch air circuit is used for both inhalation and exhalation.

[0073] 2.2.3.4 Humidifier

[0074] Delivering airflow without humidification can lead to airway dryness. Using a humidifier with an RPT device and patient interface generates humidified gas, which minimizes nasal mucosal dryness and increases patient airway comfort. Additionally, in cooler climates, warm air applied to the area within and around the patient interface on the face is generally more comfortable than cold air.

[0075] 2.2.3.5 Data Management

[0076] There may be clinical reasons for obtaining data to determine whether a patient receiving respiratory therapy is "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, in order to be considered adherent, the patient is required to use the RPT device for at least four hours each night for at least 21 or 30 consecutive days. To determine patient adherence, the RPT device provider (such as a healthcare provider) may manually obtain data describing the therapy used by patients using the RPT device, calculate usage rates over a predetermined time period, and compare them to the adherence rules. Once the healthcare provider has determined that the patient has used their RPT device according to the adherence rules, the healthcare provider may notify a third party that the patient is adherent.

[0077] The patient's treatment may benefit from other aspects of communicating treatment data to third parties or external systems.

[0078] Existing processes for communicating and managing this type of data may suffer from one or more of the following problems: high cost, time-consuming, and error-prone.

[0079] 2.2.3.6 Ventilation technology

[0080] Some forms of therapeutic systems may include a vent to allow the flushing of exhaled carbon dioxide. The vent allows gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the external space of the patient interface, such as into the environment.

[0081] 2.2.4 Screening, Diagnosis and Monitoring System

[0082] Polysomnography (PSG) is a routine system used for diagnosing and monitoring cardiopulmonary diseases, and it typically involves clinical specialists applying the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalograms (EEG), electrocardiograms (ECG), electrooculograms (EOG), and electromyograms (EMG). PSG used to treat sleep-disordered breathing involves two nights of observation in a clinic: one night for pure diagnosis, and the second night for titration of treatment parameters by a clinician. Therefore, PSG is both expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0083] Screening and diagnosis are generally described as identifying a condition based on its signs and symptoms. Screening typically provides a true / false result, indicating whether a patient's SDB is severe enough to require further investigation, while diagnosis provides clinically actionable information. Screening and diagnosis are often one-off processes, while monitoring the progression of the condition can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0084] Clinicians may be able to adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where clinicians may be unavailable or patients may not be able to afford clinician fees. Different clinicians may have differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. Summary of the Invention

[0085] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0086] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0087] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0088] One aspect of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0089] One form of this technology includes a positioning and stabilizing structure configured to provide force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes at least one strap.

[0090] One form of this technology includes a patient interface comprising an inflation chamber, a sealing formation structure, and a positioning and stabilizing structure.

[0091] One form of this technology includes a patient interface comprising an inflatable chamber pressurizable to a treatment pressure at least 4 cm H2O above ambient air pressure. The inflatable chamber includes at least one inflatable chamber inlet port, sized and configured to receive an airflow at the treatment pressure for patient breathing. The patient interface also includes a sealing structure constructed and arranged to seal with an inlet region of the patient's face surrounding the patient's airway. The sealing structure has an opening therein, such that the airflow at the treatment pressure is delivered at least to the inlet of the patient's nostrils. The sealing structure is constructed and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's respiratory cycle in use. The patient interface also includes positioning and stabilizing structures to provide force to hold the sealing structure in a therapeutically effective position on the patient's head.

[0092] Another aspect of this technology is a series of modular elements that can be interconnected to form different styles of patient interfaces.

[0093] In one form, each modular element has at least two versions or styles. These versions or styles can be used interchangeably to form different modular components.

[0094] One form of this technology includes a headgear connector comprising a retainer and a snap fastener. The retainer may include a first engagement structure and may be configured to connect to a patient interface. The snap fastener may include a second engagement structure and may be configured to connect to a strap of the patient interface. In some forms of this technology, one of the first engagement structure or the second engagement structure includes a concave engagement structure, and the other of the first engagement structure and the second engagement structure includes a convex engagement structure. In some examples, the convex engagement structure may include a rod projecting from a surface and a plurality of deflectable pins projecting from the surface and positioned around the rod. In other examples, the concave engagement structure may include a receiver defining an opening. In some forms of this technology, the headgear connector may be configured to switch between an engaged state in which the snap fastener is engaged with the retainer and a disengaged state in which the snap fastener is disengaged from the retainer. In some examples, in the engaged state, the convex engagement structure may be accommodated within the concave engagement structure.

[0095] Other examples of this technology:

[0096] a. The retainer includes the convex engagement structure, and the snap includes the concave engagement structure;

[0097] b. The opening of the container extends completely through the first surface and the second surface opposite the first surface;

[0098] c. The height of the convex joint structure is greater than the height of the opening, such that the convex joint structure extends through the opening in the joined state;

[0099] d. The opening of the container extends through the first surface and terminates before the second surface opposite the first surface;

[0100] e. The convex engagement structure includes two, three, or four deflectable pins that protrude from the surface and surround the rod;

[0101] f. A force of approximately 1.0 N to approximately 30.0 N is required to transition to this engagement state;

[0102] g. A force of approximately 1.0 N to approximately 60.0 N is required to transition from the engaged state to the disengaged state;

[0103] h. The container has a first container surface, a second container surface, and a container transition portion located between the first container surface and the second container surface, and the container transition portion protrudes deeper into the opening of the container compared to the first container surface and the second container surface.

[0104] i. Each of the plurality of posts includes a ridge projecting outward on the side of the post opposite to the rod.

[0105] j. Converting the headgear connector to the engagement state includes: as the convex engagement structure is accommodated in the concave engagement structure, the outwardly projecting ridge on each of the plurality of pins contacts the receiver conversion portion, causing the plurality of pins to deflect inward toward the rod;

[0106] k. In this engaged state, the outwardly projecting ridge of each of the plurality of prongs is located deeper within the receiver than the receiver conversion portion;

[0107] l. The retainer is removably connected to the patient interface;

[0108] m. The buckle is removably attached to the strap at the patient interface; and / or

[0109] n. At least one of the buckle and the retainer includes at least one of the following on the portion configured for contact with the patient: a pit, a bump, a groove, a notch, a serration, a ridge, a knurling, or a texture.

[0110] One form of this technology includes a patient interface comprising: a headgear including a first strap and a second strap; a sealing formation; and a headgear connector. In some examples, at least one of the headgear connectors may include: a retainer connected to the patient interface; and a snap fastener connected to the straps of the patient interface. In some forms of this technology, the headgear connector including the retainer and the snap fastener may be configured to switch between an engaged state in which the snap fastener is engaged with the retainer and a disengaged state in which the snap fastener is disengaged from the retainer.

[0111] Another form of the technology includes a headgear connector comprising a retainer and a snap fastener. The retainer may be configured to connect to a patient interface and includes a convex engagement structure. The snap fastener may be configured to connect to a strap of the patient interface and includes a concave engagement structure. In some examples, the concave engagement structure may include a receiver defining an opening, and the receiver having a first receiver surface, a second receiver surface, and a receiver transition portion located between the first receiver surface and the second receiver surface. In other examples, the convex engagement structure may include a rod and a plurality of deflectable pins surrounding the rod. According to aspects of one form of the technology, each of the plurality of pins may have a ridge projecting outward on a side opposite to the rod. In some examples, the outwardly projecting ridge of the plurality of pins forms an imaginary circle with a diameter larger than the diameter of the opening at the receiver transition portion.

[0112] In the example, the opening of the receiver extends through the opposite surface of the snap fastener.

[0113] In another example, the convex engagement structure includes two, three, or four deflectable pins.

[0114] Another form of the technology includes a patient interface comprising: a headgear having a first strap and a second strap; a sealing formation; and a pair of headgear connectors. Each headgear connector may include a retainer and a snap fastener configured to connect to at least one of the first strap or the second strap. In one example, each headgear connector may include a receptacle and a plurality of deflectable pins. According to one or more aspects of the technology, for any headgear connector, the receptacle may be incorporated into one of a corresponding snap fastener and a retainer, wherein the plurality of deflectable pins are incorporated into another of the corresponding snap fastener and retainer. According to other aspects of one or more aspects of the technology, for any headgear connector, a rod may be incorporated into one of a corresponding snap fastener and a retainer, independent of which of these components includes the corresponding receptacle and the plurality of deflectable pins of the headgear. In some examples, each of at least one set of a plurality of deflectable pins may have an outwardly projecting ridge on a side opposite to the longitudinal axis of the corresponding rod or opening of the corresponding snap fastener or retainer including the at least one set of a plurality of deflectable pins. In some examples, the outwardly projecting ridges of the corresponding plurality of deflectable inserts can form an imaginary circle with a diameter larger than the diameter of the corresponding opening at the corresponding receiver conversion section.

[0115] Another aspect of this technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0116] One aspect of this technology is a method for manufacturing equipment.

[0117] Another aspect of this technology is a method for assembling a modular system, including selecting positioning and stabilizing structures and connecting the positioning and stabilizing structures to a first liner or a second liner.

[0118] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for use 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.

[0119] One aspect of this technology is a portable RPT device that can be carried by a person (e.g., in that person's home).

[0120] One aspect of this technology is a patient interface that can be cleaned at the patient's home, for example, in soapy water, without requiring specialized cleaning equipment. Another aspect of this technology is a humidifier water tank that can be cleaned at the patient's home, for example, in soapy water, without requiring specialized cleaning equipment.

[0121] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors, such as processors for dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0122] Of course, the various parts of these aspects can form sub-aspects of this technology. Furthermore, these sub-aspects and / or the various sub-aspects and / or aspects within these aspects can be combined in various ways and also constitute additional aspects or sub-aspects of this technology.

[0123] Other features of the present technology will become apparent from the following detailed description, summary of the specification, drawings and claims. Attached Figure Description

[0124] The technology is illustrated in the accompanying drawings by way of example and not limitation, wherein similar reference numerals refer to similar elements, including:

[0125] 4.1 Breathing Therapy System

[0126] Figure 1A A system including a patient 1000 is shown, who wears a patient interface 3000 in the form of a nose pillow, which receives a positive pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient is sleeping in a supine position.

[0127] Figure 1B A system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask is shown, which receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0128] Figure 1CA system including 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 delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a side-lying position.

[0129] 4.2 Respiratory System and Facial Anatomy

[0130] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0131] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0132] Figure 2C It is a frontal view of a face with several identifiable surface anatomical features, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the lips. It also indicates the directions of up, down, radially inward, and radially outward.

[0133] 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 point, upper lip, lower lip, supramental point, nasal ridge, alar ridge, supraauricular base, and subauricular base. The vertical and horizontal directions are also indicated.

[0134] Figure 2E This is another side view of the head. It indicates the approximate location of the Frankfurt plane and the nasolabial angle. The coronal plane is also indicated.

[0135] Figure 2F A bottom view of the nose with several identifiable features is shown, including the nasolabial groove, lower lip, vermilion border of the upper lip, nostrils, subnasal point, columella, nasal protuberance, long axis of the nostrils, and midsagittal plane.

[0136] Figure 2G A side view showing the surface features of the nose.

[0137] 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.

[0138] Figure 2IAn anatomical view of the nasal region, approximately a few millimeters from the midsagittal plane, is shown, with particular emphasis on the medial crus of the septal cartilage and the greater alar cartilage.

[0139] Figure 2J A frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone, is shown. The nasal conchae, as well as the maxilla and mandible, are also indicated.

[0140] Figure 2K This diagram shows a side view of the skull, including the outline of the head surface 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.

[0141] Figure 2L The frontal lateral view of the nose is shown.

[0142] 4.3 Patient Interface

[0143] Figure 3A The patient interface and the forces acting on it during use are shown.

[0144] Figure 3B A schematic diagram of a cross-section passing through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0145] Figure 3C A schematic diagram of a cross-section passing through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0146] Figure 3D 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 is zero.

[0147] Figure 3E A schematic diagram of a cross-section of the structure at a 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 has a relatively small amplitude compared to that shown.

[0148] Figure 3F A schematic diagram of a cross-section of the structure at a 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 has a relatively large amplitude compared to that shown.

[0149] Figure 3G The padding for a face mask comprising two pillows is shown. The outer surface of the padding is indicated. The edges of the surface are indicated. The vaulted and saddle-shaped areas are indicated.

[0150] Figure 3H The padding used for the face mask is shown. The outer surface of the padding is indicated. The edge of the surface is indicated. The path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle-shaped areas and one dome-shaped area are indicated.

[0151] Figure 3I A surface with a structure having a one-dimensional hole is shown. The illustrated planar curve forms the boundary of the one-dimensional hole.

[0152] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The illustrated surface definition. Figure 3I Two-dimensional holes in the structure.

[0153] Figure 3K It shows Figure 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. The definition is also shown. Figure 3I The surface of a two-dimensional hole in a structure.

[0154] Figure 3L A face mask with an inflatable airbag as padding is shown.

[0155] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the bladder is also shown. This inner surface defines a two-dimensional aperture in the mask.

[0156] Figure 3N It shows crossing Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0157] Figure 3O Exemplifies the left-hand rule.

[0158] Figure 3P The right-hand rule is illustrated.

[0159] Figure 3Q The left ear is shown, including the left ear spiral.

[0160] Figure 3R The right ear is shown, including the right ear spiral.

[0161] Figure 3S A right-handed spiral is shown.

[0162] Figure 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the face mask.

[0163] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0164] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The orientation of this view is orthogonal to the central contact plane. Figure 3V The sagittal plane divides the air chamber into two equal parts: the left-hand side and the right-hand side.

[0165] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, which is in Figure 3V The image shows a cut-off section in the sagittal plane. An "intermediate contact" plane is shown. This intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of chord 3210, which lies in the sagittal plane and contacts the gasket of the inflation chamber only at two points (upper point 3220 and lower point 3230) in the sagittal plane. Depending on the geometry of the gasket in this region, the intermediate contact plane can be a sectional section at the upper and lower points.

[0166] Figure 3X The location shown is for use on the face. Figure 3U The air chamber 3200. When the air chamber is in the use position, the sagittal plane of the air chamber 3200 generally coincides with the midsagittal plane of the face. When the air chamber is in the use position, the 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 bridge of the nose, while the lower point 3230 is located on the upper part of the lip.

[0167] Figure 3Y The patient interface with a catheter tip is shown, as well as the force applied to the patient interface during use.

[0168] 4.4RPT device

[0169] Figure 4A An RPT device of one form according to the present technology is shown.

[0170] Figure 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to the blower and patient interface. The blower is positioned upstream of the patient interface, and the patient interface is positioned downstream of the blower, regardless of the actual flow direction at any given moment. Articles within the pneumatic path between the blower and the patient interface are positioned downstream of the blower and upstream of the patient interface.

[0171] 4.5 Humidifier

[0172] Figure 5A An isometric view of one form of humidifier according to the present technology is shown.

[0173] Figure 5B An isometric view of a humidifier according to the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0174] 4.6 Headgear and Modular Design

[0175] Figure 6A A perspective view of the padding of a patient interface is shown, which is configured to be worn by a patient and deliver pressurized air to the patient's nose and mouth.

[0176] Figure 6B A perspective view of the padding of a patient interface is shown, which is configured to be worn by a patient and deliver pressurized air to the patient's nose.

[0177] Figure 6C It shows that it can be used with Figure 6A padding or Figure 6B A perspective view of the tube used with the liner.

[0178] Figure 6D It shows that it can be used with Figure 6A padding or Figure 6B A perspective view of the hardener arm used with the padding.

[0179] Figure 6E It shows that it can be used with Figure 6A A perspective view of the headgear straps used with padding.

[0180] Figure 6F It shows that it can be used with Figure 6B A perspective view of the headgear straps used with padding.

[0181] Figure 6G It shows removable assembly to Figure 6C pipe or Figure 6D Front view of a pair of conduit sleeves on the hardener arm.

[0182] Figure 6H It is worn connected to Figure 6C pipe, Figure 6E Headgear and straps Figure 6G The conduit sleeve Figure 6A A front view of the patient with the padding.

[0183] 4.7 Headgear Connector

[0184] Figure 7A A patient interface including a headgear connector is shown in one form according to the present technology.

[0185] Figures 7B to 7D Top perspective view, side perspective view and bottom perspective view of a disengaged portion of a headgear connector according to the present technology are shown respectively.

[0186] Figures 7E to 7G The top, bottom, and side perspective views of another disengaged portion of the headgear connector are shown respectively.

[0187] Figures 7H to 7J It shows multiple engagement states. Figures 7B to 7G The headgear connector part.

[0188] Figure 7K It shows from and Figure 7J The plane corresponding to line 7K-7K in the middle faces as follows Figure 7J A cross-sectional view of the mating portion of the headgear connector, viewed from the indicated direction K.

[0189] Figures 7L to 7P A headgear connector in one form according to the present technology is shown in various states that lead to disengagement.

[0190] Figure 7Q A side perspective view of a disengaged portion of a headgear connector according to the present technology is shown.

[0191] Figures 7R to 7T It shows including Figure 7Q The various parts of the headgear connector are in multiple engagement states.

[0192] Figures 7U to 7W The top, bottom, and side perspective views of another disengaged portion of the headgear connector are shown respectively.

[0193] Figure 7X and Figure 7Y It shows Figures 7U to 7W A side view of an alternative embodiment of the disengaged portion of the headgear connector.

[0194] Figure 7Z It shows from and Figure 7J The plane corresponding to line 7K-7K in the middle faces as follows Figure 7J The direction K indicated includes the observation of Figures 7U to 7W A cross-sectional view of the engagement portion of the headgear connector, showing the disengaged engagement part.

[0195] Figure 7AA A bottom view of the disengaged portion of the headgear connector is shown.

[0196] Figure 8A perspective view of the engagement portion of a headgear connector according to the present technology is shown.

[0197] Figure 9A A patient interface including a headgear connector is shown in one form according to the present technology.

[0198] Figures 9B to 9D Top perspective view, bottom perspective view and side perspective view of a disengaged portion of a headgear connector according to the present technology are shown respectively.

[0199] Figures 9E to 9G Top perspective view, bottom perspective view and side perspective view of another disengaged portion of a headgear connector according to the present technology are shown respectively.

[0200] Figure 9H yes Figure 9F A partial perspective magnified view of a portion of the headgear connector.

[0201] Figure 9I It shows from and Figure 9E The plane corresponding to line 9I-9I in the middle faces as follows Figure 9E A cross-sectional view of a portion of the headgear connector as observed in the indicated direction I.

[0202] Figure 9J It shows from and Figure 9F The plane corresponding to line 9J-9J in the middle faces as follows Figure 9F A cross-sectional view of a portion of the headgear connector observed in the indicated direction J.

[0203] Figure 9K It shows from and Figure 9G The plane corresponding to line 9K-9K in the middle faces as follows Figure 9G A cross-sectional view of a portion of the headgear connector observed in the indicated direction K.

[0204] Figures 9L to 9O It shows multiple engagement states. Figures 9B to 9K The various parts of the headgear connector.

[0205] Figure 10A A headgear connector according to this technology is shown as one form of attachment to a patient interface.

[0206] Figure 10B It shows Figure 10A The rod of the retainer's engagement structure is shown.

[0207] Figure 10C It shows the disengaged state. Figure 10A It is part of the headgear connector.

[0208] Figures 10D to 10GThis illustrates one form of a device in multiple engagement states according to the present technology. Figure 10A The headgear connector.

[0209] Figure 10H One form according to the present technology is shown. Figure 10A Front view of the headgear connector.

[0210] Figure 11A A patient interface comprising a headgear connector in a disengaged state, according to one form of the present technology, is shown.

[0211] Figure 11B It shows the disengaged state. Figure 11A The various parts of the headgear connector.

[0212] Figure 11C It shows the state of engagement. Figure 11A The various parts of the headgear connector.

[0213] Figure 11D A patient interface of a headgear connector (but without headgear straps and without an inflation chamber) in an engaged state is shown according to the present technology.

[0214] Figure 12A The portions of a headgear connector in a disengaged state, according to one form of the present technology, are shown.

[0215] Figure 12B It shows the state of engagement. Figure 12A The various parts of the headgear connector. Detailed Implementation

[0216] Before describing the technology in further detail, it should be understood that the technology is not limited to the specific examples described herein, and the specific examples described herein may vary. 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.

[0217] 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 one example may be combined with one or more features of another example or other examples. Furthermore, any single feature or combination of features from any of the examples may constitute another example.

[0218] 5.1 Therapy

[0219] In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the inlet of the airway of a patient 1000.

[0220] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0221] In some examples of this technology, mouth breathing is restricted, constrained, or prevented.

[0222] 5.2 Respiratory Therapy System

[0223] In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0224] 5.3 Patient Interface

[0225] According to one aspect of this technology, such as Figure 3A The illustrated noninvasive patient interface 3000 includes the following functional aspects: a seal-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3470 for connecting to an air circuit 4170, and a forehead support 3001. 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 seal-forming structure 3100 is arranged to surround the inlet of the patient's airway to maintain positive pressure at the inlet of the patient's airway. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0226] 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.

[0227] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure higher than that of the environment, for example at least 2, 4, 6, 10 or 20 cmH2O relative to the environment.

[0228] 5.3.1 Sealing Formation Structure

[0229] In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs (the actual sealing surface) may vary over time and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0230] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0231] In some forms of this technology, the sealing structure 3100 is constructed from a biocompatible material (e.g., silicone rubber).

[0232] The sealing structure 3100 according to this technology can be constructed from a soft, flexible, elastic material (such as silicone).

[0233] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each of which is configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, and another of the same sealing formation structure suitable for small-sized heads but not for large-sized heads.

[0234] 5.3.1.1 Nasal pillow

[0235] In one form, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is constructed and arranged to form a seal with the corresponding nostril of the patient's nose.

[0236] A nasal pillow according to one aspect of the present invention includes: a truncated cone, at least a portion of which forms a seal on the underside of the patient's nose; a handle; and a flexible region located on the underside of the truncated cone and connecting the truncated cone to the handle. Furthermore, the structure to which the nasal pillow of the present invention is connected includes a flexible region adjacent to the base of the handle. These flexible regions can work together to facilitate a universal joint structure that accommodates relative displacement and angular movement of the truncated cone and the structure to which the nasal pillow is connected. For example, the truncated cone can be axially displaced toward the structure to which the handle is connected.

[0237] 5.3.1.2 Pure Nasal Mask

[0238] In one embodiment, the patient interface 3000 includes a sealing structure 3100 configured to seal around the inlet of the patient's nasal airway rather than around the patient's mouth. The sealing structure 3100 may be configured to seal over the patient's upper lip. The patient interface 3000 allows the patient's mouth to remain uncovered. This patient interface 3000 can deliver a supply of air or breathable gas to the two nostrils of the patient 1000 instead of the mouth. This type of patient interface may be identified as a nasal mask only.

[0239] One form of the pure nasal mask according to the present technology is a mask conventionally identified as a "nasal mask," having a sealing forming structure 3100 configured to surround the nose on the patient's face and seal over the bridge of the nose. The shape of the nasal mask can typically be triangular. In one form, the non-invasive patient interface 3000 includes the sealing forming structure 3100, which, in use, forms a seal on the upper lip region (e.g., the upper lip), on at least a portion of the nasal ridge above the nasal tip or nasal protuberance, and on each lateral side of the patient's face, such as near the nasolabial folds. Figure 1B The patient interface 3000 shown has this type of sealing structure 3100. The patient interface 3000 can deliver a supply of air or breathable gas to the two nostrils of the patient 1000 through a single orifice.

[0240] Another form of pure nasal mask can seal around the lower periphery of the patient's nose without engaging the user's nasal ridge. For example, this type of patient interface 3000 can be identified as a "nose pad" mask, and the sealing forming structure 3100 can be identified as a "nose pad liner".

[0241] In some forms, a nasal mask may include a nasal pillow as described above.

[0242] 5.3.1.3 Nose and mouth mask

[0243] In one embodiment, the patient interface 3000 includes a sealing structure 3100 configured to form a seal around the inlet of the patient's nasal airway and also around the patient's mouth. The sealing structure 3100 may be configured to form a seal against the patient's face near the chin area. The patient interface 3000 can deliver a supply of air or breathable gas to the patient's two nostrils and mouth. This type of patient interface may be identified as a nasogastric mask.

[0244] One form of the naso-mouth mask according to the present technology is conventionally identified as a "full-face mask," having a sealing formation structure 3100 configured to seal around the nose, below the mouth, and above the bridge of the nose on the patient's face. The shape of the naso-mouth mask can typically be triangular. In one form, the patient interface 3000 includes the sealing formation structure 3100, which, in use, forms a seal on the patient's chin area (which may include the patient's lower lip and / or the area directly below the lower lip), the patient's bridge of the nose or at least a portion of the nasal ridge above the nasal protuberance, and the cheek area of ​​the patient's face. Figure 1CThe patient interface 3000 shown belongs to this type. The patient interface 3000 can deliver a supply of air or breathable gas to the nostrils and mouth of the patient 1000 through a single orifice. This type of sealing structure 3100 can be referred to as a "nasal and oral liner".

[0245] In another form, the patient interface 3000 includes a sealing formation structure 3100 that, in use, forms a seal against the lower and / or anterior surface of the nasal projection portion of the patient's nose, the nasal alae of the patient's nose, and the patient's face on each lateral side of the patient's nose (e.g., near the nasolabial folds) in the patient's chin region (which may include the patient's lower lip and / or the area directly below the lower lip). The sealing formation structure 3100 may also form a seal against the patient's upper lip. A patient interface 3000 of this type may have a single opening configured to deliver an airflow or breathable gas to the patient's two nostrils and mouth; may have an oral orifice configured to deliver air or breathable gas to the mouth and nasal orifices configured to deliver air or breathable gas to the nostrils; or may have an oral orifice for delivering air to the patient's mouth and two nasal orifices for delivering air to the corresponding nostrils. A patient interface 3000 of this type may have a nasal portion and an oral portion that seals against the patient's face in a position similar to a nose pad.

[0246] In another form of the nasal mask, the patient interface 3000 may include a sealing formation 3100 having a nasal portion including a nasal pillow and an oral portion configured to form a seal on the patient's face around the patient's mouth.

[0247] In some forms, the sealing structure 3100 may have a nasal portion that is separate from and distinct from the mouth. In other forms, the sealing structure 3100 may form a continuous seal around the patient's nose and mouth.

[0248] It should be understood that the above examples of different forms of patient interface 3000 do not constitute an exhaustive list of possible configurations. In some forms, patient interface 3000 may include combinations of different features of the pure nasal mask and naso-mouth mask examples described above.

[0249] 5.3.2 Inflation Chamber

[0250] The air chamber 3200 has a periphery whose shape is designed to complement the surface contour of a typical face in the area where a seal will be formed during use. During use, the boundary edge of the air chamber 3200 is positioned close to the adjacent surface of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 may extend around the entire periphery of the air chamber 3200 during use. In some forms, the air chamber 3200 and the sealing structure 3100 are formed from a single sheet of homogeneous material.

[0251] 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. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve adherence to therapy.

[0252] In some forms of this technology, the air chamber 3200 is constructed of a transparent material (e.g., transparent polycarbonate). Using transparent materials reduces the obtrusiveness of the patient interface and helps improve adherence to the therapy. Transparent materials also help clinicians observe how the patient interface is positioned and functions.

[0253] In some forms of this technology, the air chamber 3200 is constructed of a translucent material. Using a translucent material can reduce the obtrusiveness of the patient interface and help improve adherence to the therapy.

[0254] In some forms, the air chamber 3200 is constructed from a rigid material such as polycarbonate. The rigid material can provide support for the seal-forming structure.

[0255] In some forms, the air chamber 3200 is made of a flexible material (e.g., constructed from soft, flexible, elastic materials such as silicone, textiles, foam, etc.). For example, in one example, it may be formed of a material with a Young's modulus of 0.4 GPa or lower, such as foam. In some forms of the present technology, the air chamber 3200 may be made of a material with a Young's modulus of 0.1 GPa or lower, such as rubber. In other forms of the present technology, the air chamber 3200 may be made of a material with a Young's modulus of 0.7 MPa or less (e.g., between 0.7 MPa and 0.3 MPa). An example of such a material is silicone.

[0256] 5.3.2.1 Multiple openings

[0257] like Figure 6A and Figure 6BAs shown, different air chambers 3200-1, 3200-2 can be formed as part of multi-opening liners 3050-1, 3050-2. In the illustrated example, each of liners 3050-1, 3050-2 includes three openings, although alternative liners can be formed with more or fewer openings.

[0258] In some forms, different openings can serve different purposes. For example, some openings may be solely entrance openings, while others may be solely exit openings.

[0259] In other forms, at least one opening can provide two different functions. For example, during the same respiratory cycle, an opening can serve as both an inlet and an outlet.

[0260] These multiple openings allow for various configurations of air delivery into the inflation chambers 3200-1 and 3200-2. For example, depending on the patient's needs and / or comfort, the patient can use a given pad 3050-1 or 3050-2 in a "tube-up" configuration (e.g., using a catheter hood as described below) or a "tube-down" configuration (e.g., using a single catheter in front of the patient's face).

[0261] 5.3.2.1.1 Nose and mouth mask

[0262] like Figure 6A As shown, the inflation chamber 3200-1 includes a pair of inflation chamber inlet ports 3254-1, which can be used to deliver gas into and / or out of the inflation chamber 3200-1. The inflation chamber inlet ports 3254-1 can be located on opposite sides of the inflation chamber 3200-1 (e.g., left and right sides).

[0263] In some forms, the air chamber 3200-1 may also include at least one vent opening 3402-1 (see example...) Figure 6A The vent opening 3402-1 can be located at the center of the inflation chamber 3200-1. For example, the vent opening 3402-1 can be located between the inlet ports 3254-1 of the inflation chamber.

[0264] In some forms, the inflation chamber 3200-1 may include a pair of grooves 3266-1. Each groove 3266-1 may be located near one of the inflation chamber inlet ports 3254-1. Each groove 3266-1 may form a partially recessed surface.

[0265] 5.3.2.1.2 Pure Nasal Mask

[0266] The air chamber 3200-2 of the pure nasal liner 3050-2 can be similar to the air chamber 3200-1 of the oronasal liner 3050-1. The following describes only some similarities and differences between the air chambers 3200-1 and 3200-2.

[0267] like Figure 6B As shown, the inflation chamber 3200-2 includes a pair of inflation chamber inlet ports 3254-2, which can be used to deliver gas into and / or out of the inflation chamber 3200-2. The inflation chamber inlet ports 3254-2 may be located on opposite sides of the inflation chamber 3200-2 (e.g., left and right sides).

[0268] In some forms, the air chamber 3200-2 may also include at least one vent opening 3402-2 (see example...) Figure 6B The vent opening 3402-2 can be located at the center of the inflation chamber 3200-2. For example, the vent opening 3402-2 can be located between the inlet ports 3254-2 of the inflation chamber.

[0269] In some forms, the inflation chamber 3200-2 may include a pair of grooves 3266-2. Each groove 3266-2 may be located near one of the inflation chamber inlet ports 3254-2. Each groove 3266-2 may form a partially recessed surface.

[0270] 5.3.3 Positioning and Stabilizing Structure

[0271] The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by a positioning and stabilizing structure 3300. The positioning and stabilizing structure 3300 may include and function as a "headgear" because it engages with the patient's head to hold the patient interface 3000 in a sealed position. Examples of the positioning and stabilizing structure may be as follows... Figure 3A As shown.

[0272] 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 (i.e., F). 充气 ).

[0273] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the effects of gravity on the patient interface 3000.

[0274] Continue to refer to Figure 3A The 3300 provides force F for positioning and stabilizing the structure. PSS This force helps maintain the air chamber 3200 in a sealed position on the patient's face. Positioning and stabilizing force F PSSIt can be the resultant force of various forces from different components of the positioning and stabilizing structure 3300. For example, the headgear straps can individually provide a strap force F. 绑带 This is to hold the sealing structure 3100 on the patient's face. The force F can also be guided at least partially upwards. 绑带 In order to overcome gravity F g The gravity F can be specifically shown for the sealing structure 3100 and the inflation chamber 3200. g However, gravity will act on the entire patient interface 3000 (i.e., along the illustrated gravity F). g (Same direction).

[0275] Gravity F g It can be related to frictional force F f Conversely, this frictional force can be relative to gravity F. g Acting in the direct opposite direction. When gravity pulls the sealing structure 3100 and the inflation chamber 3200 downwards (as from... Figure 3A (View in -1), friction force F f It will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F on the upper part of their lips (and / or other surfaces of the patient's face that are in contact with the seal-forming structure 3100). f This is to counteract downward movement (which helps stabilize the pad in place). Despite the frictional force F... f Specifically shown as the gravity F of the sealing structure 3100 and the inflation chamber 3200 g Conversely, however, the component of the total frictional force (not shown) will also be related to the gravity F associated with the positioning and stabilizing structure 3300 of the patient interface 3000 and any other parts. g Relatively speaking, friction can act at any point along the patient interface 3000 that contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair). In some forms, gravity F g It can also be offset by the vertical component of the reaction force from the patient’s face, which acts on the sealing structure 3100, for example, in the nasal ridge and chin area of ​​the patient’s face.

[0276] In some forms, the sum of all forces can equal zero, so that the patient interface 3000 is in equilibrium (e.g., does not move along the patient's face during use). Specifically, gravity F g And blowing force F 充气 The tendency is to move the seal-forming structure 3100 away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract the gravitational force F g And blowing force F充气 (and any frictional force F) f And to keep the sealing structure 3100 correctly positioned. Although positioning and stabilizing force F PSS Possibly exceeding gravity F g And blowing force F 充气 The sum of (where any additional positioning and stabilizing forces F) PSS (This is balanced by the reaction forces from the patient's head acting on various parts of the patient interface 3000) and still maintaining the sealing structure 3100 in the proper sealing position, but this may sacrifice patient comfort. When the net force on the patient interface 3000 is zero and the positioning and stabilizing force F... PSS When the force is just strong enough to achieve this, maximum patient comfort can be achieved. In some examples, the positioning and stabilizing structure 3300 can be adjustable, such that when assembled, the positioning and stabilizing force F... PSS Greater than the precise equilibrium gravity F g And blowing force F 充气 The required force is sufficient to hold the patient interface 3000 firmly against the patient's head so that destructive forces that may occur during use (such as tube resistance or lateral shunting of the inflation chamber 3200 during lateral recumbency) will not break the seal. As described below, when using the patient interface 3000, the various positions of the patient's head can determine the positioning and stabilizing force F necessary to achieve balance. PSS .

[0277] 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.

[0278] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with how a patient wears the device 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 having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0279] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be not too large and bulky to prevent the patient from lying down in a supine sleeping position, wherein the back area of ​​the patient's head is on the pillow.

[0280] 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 on the pillow in a side-sleeping position with the side of the patient's head on the pillow.

[0281] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a disengagement portion located between the front and rear portions of the positioning and stabilizing structure 3300. The disengagement portion does not resist compression and can be, for example, a flexible or loose bandage. The disengagement portion is constructed and arranged such that when the patient rests their head on the pillow, its presence prevents forces on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0282] In one form of this technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In another form, the fabric outer layer includes a loop material to engage with a hook material portion.

[0283] In some forms of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) bandage. For example, the bandage may be configured to be tensioned during use and to guide forces to create a sealing contact between the sealing structure and a portion of the patient's face. In an example, the bandage may be configured as a tie.

[0284] In one form of this technology, the positioning and stabilizing structure includes a first frenulum, which is constructed 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.

[0285] In one form of the present technology applicable to a pure nasal mask or a full face mask, the positioning and stabilizing structure includes a second strap that is constructed 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.

[0286] In one form of this technology suitable for a pure nasal mask or a full-face mask, 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 move away from each other.

[0287] In some forms of this technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. An advantage of this is that the strap is more comfortable for the patient lying on it when they are sleeping.

[0288] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap configured to be breathable to allow moisture transfer through the strap.

[0289] In some forms of this technology, a system is provided that includes 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, and another form of the positioning and stabilizing structure suitable for small-sized heads but not for large-sized heads.

[0290] 5.3.3.1 Catheter head cover

[0291] 5.3.3.1.1 Catheter head sheath

[0292] In some forms of this technology, the positioning and stabilization structure 3300 includes one or more head tubes 3350 that deliver pressurized air received from a conduit forming part of an air circuit 4170 from the RPT device to the patient's airway, for example through an inflation chamber 3200 and a sealing structure 3100. Figure 3Y , Figure 6C and Figure 6H In the form of the present technology illustrated herein, the exemplary positioning and stabilization structure 3300 includes two tubes 3350 for delivering air from the air circuit 4170 to the inflation chamber 3200. The tubes 3350 are configured to position and stabilize the sealing formation 3100 of the patient interface 3000 at an appropriate location on the patient's face (e.g., nose and / or mouth) during use. This allows a conduit of the air circuit 4170 providing pressurized airflow to connect to the connection port 3470 of the patient interface (see, for example...). Figure 3Y The connection port is located in a position other than the front of the patient's face, such as on the top of the patient's head.

[0293] exist Figure 3Y In the illustrated form of this technology, the positioning and stabilizing structure 3300 includes two tubes 3350, each positioned on a different side of the patient's head during use, and extending above the corresponding ear (above the supraacus base point of the patient's head) through the corresponding cheek region to a curved tube 3475 at the top of the patient's head. This form of technology may be advantageous because if the patient sleeps with their head turned to the side and one of the tubes 3350 is compressed to block or partially block the gas flow along that tube 3350, the other tube 3350 remains open to supply pressurized gas to the patient. In other examples of this technology, the patient interface 3000 may include a different number of tubes, such as one tube, or two or more tubes.

[0294] In one example where the patient interface has a tube 3350, the single tube 3350 is positioned on one side of the patient's head during use (e.g., across a cheek area), and a strap forming part of the positioning and stabilizing structure 3300 is positioned on the other side of the patient's head during use (e.g., across another area) to help secure the patient interface 3000 to the patient's head. For example, the tube 3350 and the strap may each be under tension during use to help hold the sealing structure 3100 in a sealed position.

[0295] In one embodiment, the tube 3350 may be at least partially extendable, such that the tube 3350 and the bandage can be adjusted to substantially equal lengths when worn by a patient. This allows for substantially symmetrical adjustment between the tube 3350 and the bandage, such that the sealing structure remains substantially centered.

[0296] exist Figure 3Y In the illustrated embodiment, two tubes 3350 are fluidly connected to each other at their upper ends and fluidly connected to a connection port 3470. In some examples, the two tubes 3350 are integrally formed, while in other examples, the tubes 3350 are formed separately but connected in use and can be disconnected, for example, for cleaning or storage. When using separate tubes, they can be indirectly connected together, for example, each can be connected to a T-connector. The T-connector can have two arms / branches, each of which can be fluidly connected to a corresponding tube 3350. Additionally, the T-connector can have a third arm or opening that provides a connection port 3470 for fluidly connecting to an air circuit 4170 in use. This opening can be an inlet 3332 for receiving a pressurized airflow (see, for example...). Figure 6C and Figure 6H ).

[0297] In some forms, the third arm of a T-connector can be substantially perpendicular to each of the first two arms.

[0298] In some forms, the third arm of a T-connector can be formed at an angle relative to each of the first two arms.

[0299] In some configurations, a Y-shaped connector can be used instead of a T-shaped connector. The first two arms can be tilted relative to each other, and the third arm can be tilted relative to the first two arms. The angled shape of the first two arms can resemble the shape of the patient's head to conform to that shape.

[0300] In some forms, at least one arm of the T-connector (or Y-connector) can be flexible. This allows the connector to bend based on the shape of the patient's head and / or the forces in the positioning and stabilizing structure 3300.

[0301] In some forms, at least one arm of a T-connector (or Y-connector) can be at least partially rigidified. This helps maintain the shape of the connector so that bending of the connector does not block the airflow path.

[0302] The tube 3350 may be formed of a flexible material, such as an elastomer, like silicone or TPE, and / or of one or more textile and / or foam materials. The tube 3350 may have a pre-formed shape and be able to bend or move into another shape when a force is applied, but can return to the original pre-formed shape when the force is no longer present. The shape of the tube 3350 may be generally arched or curved, approximating the head contour between the top of the patient's head and the nasal or oral region.

[0303] In some examples, the one or more tubes 3350 are compression-resistant to prevent blockage in the event of compression during use (e.g., if pressed between a patient's head and a pillow, especially if only one tube 3350 is present). The tube 3350 may be formed with sufficient structural stiffness to resist crushing, or may be as described in U.S. Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0304] Each tube 3350 can be configured to receive an airflow from a connection port 3470 located at the top of the patient's head and deliver that airflow to a sealing structure 3100 located at the entrance to the patient's airway. Figure 3Y and Figure 6H In the example shown, each tube 3350 is located in use along a path extending from the air chamber 3200 through the patient's cheek region and above the patient's ear to the bend 3475. For example, a portion of each tube 3350 near the air chamber 3200 may cover the maxillary region of the patient's head in use. Another portion of each tube 3350 may cover the area of ​​the patient's head above the supraauricular basal point. Each tube 3350 may also be located on one or both of the patient's sphenoid and / or temporal bones and the patient's frontal and parietal bones. The bend 3475 may be located on the patient's parietal bone, frontal bone, and / or at the junction between them (e.g., the coronal suture).

[0305] In some forms of this technology, the patient interface 3000 is configured such that the connection port 3470 can be positioned across a range spanning the top of the patient's head, thus allowing the patient interface 3000 to be positioned to suit the comfort or fit of an individual patient. In some examples, the headgear 3350 is configured to allow the upper portion of the patient interface 3000 (e.g., the connection port 3470) to move relative to the lower portion of the patient interface 3000 (e.g., the inflation chamber 3200). That is, the connection port 3470 can be at least partially disengaged from the inflation chamber 3200. Thus, the sealing structure 3100 can form an effective seal with the patient's face, regardless of the position of the connection port 3470 on the patient's head (at least within a predetermined range of positions).

[0306] As described above, in some examples of this technology, the patient interface 3000 includes a sealing-forming structure 3100 in the form of a bracket pad, which is typically located below the nose and seals to the lower periphery of the nose (e.g., a nasal floor pad). A positioning and stabilizing structure 3300, including a tube 3350, can be configured and arranged to pull the sealing-forming structure 3100 into the patient's face below the nose using a sealing force in a rear-upward direction (e.g., a postero-superior direction). The postero-superior sealing force allows the sealing-forming structure 3100 to form a good seal against the lower periphery of the patient's nose and the forward-facing surfaces of the patient's face, such as on either side of the patient's nose and above the patient's lips.

[0307] The catheter, such as a headband, which forms part of the positioning and stabilizing structure 3300, can provide a force F that facilitates positioning and stabilization. PSS The force. For example... Figure 3Y As illustrated, the positioning and stabilizing force F PSS It can be the resultant force of various forces from different elements of the positioning and stabilizing structure 3300. For example, each conduit can provide a force F that guides in the posterior and corresponding lateral directions. 导管 This is to keep the sealing structure 3100 against the patient's face (entering the upper lip and sealing below the nose) and to counteract the positive pressure in the air chamber 3200 to lift it away from the face (i.e., F 充气 It can also guide the force F at least partially in the upward direction. 导管 In order to overcome gravity F g .

[0308] In some forms, when the catheter is filled with pressurized air, it can provide a force directed towards the patient's head. This force can help clamp the patient's head. This force can be caused by the inflation of the catheter during normal use. In some forms, this force can provide cushioning for the patient's head. The catheter can be designed to limit expansion to prevent excessive clamping of the patient's head.

[0309] The position of the patient's head can also change the clamping force of the catheters. For example, if the patient is lying on their side, the weight of the patient's head can compress one catheter, while another catheter (e.g., on the side not between the patient's head and the sleeping surface, such as a pillow) can additionally expand in order to maintain substantially the same pressurized airflow rate.

[0310] Gravity F g It can be related to frictional force F f Conversely, this frictional force can be relative to gravity F. g Acting in the direct opposite direction. When gravity pulls the sealing structure 3100 and the inflation chamber 3200 downwards (as from... Figure 3A (See the image below) Friction force F f It will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F on the upper part of their lips (and / or other surfaces of the patient's face that are in contact with the seal-forming structure 3100). f This is to counteract downward movement (which helps stabilize the pad in place). Despite the frictional force F... f Specifically shown as the gravity F of the sealing structure 3100 and the inflation chamber 3200 g Conversely, however, the component of the total frictional force (not shown) will also be related to the gravity F associated with the positioning and stabilizing structure 3300 of the patient interface 3000 and any other parts. g Relatively speaking, friction can act at any point along the patient interface 3000 that contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair).

[0311] In some forms, the sum of all forces can equal zero, so that the patient interface 3000 is in equilibrium (e.g., does not move along the patient's face during use). Specifically, gravity F g And blowing force F 充气 The tendency is to move the seal-forming structure 3100 away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract the gravitational force F g And blowing force F 充气 (and any frictional force F) f And to keep the sealing structure 3100 correctly positioned. Although positioning and stabilizing force F PSS Possibly exceeding gravity F g And blowing force F 充气 The sum of (where any additional positioning and stabilizing forces F) PSS(This is balanced by the reaction forces from the patient's head acting on various parts of the patient interface 3000) and still maintaining the sealing structure 3100 in the proper sealing position, but this may sacrifice patient comfort. When the net force on the patient interface 3000 is zero and the positioning and stabilizing force F... PSS When the force is just strong enough to achieve this, maximum patient comfort can be achieved. In some examples, the positioning and stabilizing structure 3300 can be adjustable, such that when assembled, the positioning and stabilizing force F... PSS Greater than the precise equilibrium gravity F g And blowing force F 充气 The required force is sufficient to hold the patient interface 3000 firmly against the patient's head so that destructive forces that may occur during use (such as tube resistance or lateral shunting of the inflation chamber 3200 during lateral recumbency) will not break the seal. As described below, when using the patient interface 3000, the various positions of the patient's head can determine the positioning and stabilizing force F necessary to achieve balance. PSS .

[0312] 5.3.3.1.2 Extendable and non-extendable tube sections

[0313] In some examples of this technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tubes 3350 may include one or more extendable segments, for example, formed by an extendable accordion-like structure. In some forms, the patient interface 3000 may include a positioning and stabilizing structure 3300 comprising at least one gas delivery tube having a tube wall having an extendable accordion-like structure. Figure 3Y The patient interface 3000 shown includes a tube 3350, the upper portion of which includes extendable tube sections, each tube section being in the form of an extendable accordion-like structure 3328.

[0314] In some forms, the extendable accordion-like structure 3328 can be formed as a series of ridges and grooves on the surface of the tube 3350. The accordion-like structure 3328 can be biased toward a retracted position and can be moved to an extended position when the patient is prone and the structure 3300 is positioned and stabilized. Because portions of the tube 3350 can be substantially non-extendable (e.g., a non-extendable tube segment 3363), the accordion-like structure 3328 allows the positioning and stabilizing structure 3300 to be stretched to fit different head sizes. This allows a single-size tube 3350 to be used with multiple head sizes. For example, due to the accordion-like structure 3328, the positioning and stabilizing structure 3300 can be “one-size-fits-all.” Alternatively, the tube 3350 can be manufactured in multiple sizes (e.g., small, medium, large). The patient can choose a length that most closely matches their head, and the accordion-like structure 3328 can be slightly adjusted to fit an individual patient.

[0315] In some configurations, inlet 3332 may be located in the middle of the conduit. For example, conduit 3350 may be symmetrical about inlet 3332 via at least one axis.

[0316] The cross-sectional shape of the non-extendable segment 3363 of tube 3350 can be circular, elliptical, oval, D-shaped, or rounded rectangular, as described, for example, in U.S. Patent No. 6,044,844. A cross-sectional shape that presents a flat surface on the side of the tube facing and contacting other parts of the patient's face or head can be more comfortable to wear than a tube with, for example, a circular cross-section.

[0317] In some examples of this technology, a non-extendable tube segment 3363 connects to the inflation chamber 3200 at a low angle. The headgear tube 3350 may extend downwards to the side of the patient's head and then bend forward and inwards to connect to the inflation chamber 3200 in front of the patient's face. Before connecting to the inflation chamber 3200, the tube 3350 may extend to the same vertical position as the connection to the inflation chamber 3200, or in some examples, at its lower position. That is, the tube 3350 may protrude at least partially upwards before connecting to the inflation chamber 3200. A portion of the tube 3350 may be located below the inflation chamber 3200 and / or the sealing forming structure 3100. The tube 3350 may contact the patient's face below the cheekbone, which may be more comfortable than contacting the cheekbone and may avoid excessively blurring the patient's peripheral vision.

[0318] 5.3.3.1.3 Catheter head connection port

[0319] In some forms of this technology, the patient interface 3000 may include a connection port 3470 located near the upper, outer, or rear portion of the patient's head. For example, in Figure 3Y In the illustrated form of the present technology, the connection port 3470 is located at the top of the patient's head (e.g., in a position relative to the patient's head). In this example, the patient interface 3000 includes a bend 3475 forming the connection port 3470. The bend 3475 may be configured to be fluidly connected to a conduit of the air circuit 4170. The bend 3475 may be configured to rotate relative to the positioning and stabilizing structure 3300 to at least partially disengage the conduit from the positioning and stabilizing structure 3300. In some examples, the bend 3475 may be configured to rotate by rotating about a substantially vertical axis, and in some specific examples, by rotating about two or more axes. In some examples, the bend may include a tube 3350 or be connected to the tube via a ball-and-socket joint. The connection port 3470 may be located in the sagittal plane of the patient's head during use.

[0320] Patient interfaces with a connection port not positioned in front of the patient's face may be advantageous because some patients may find catheters connected to patient interfaces in front of their face unsightly and / or not prominent. For example, a catheter connected to a patient interface in front of the patient's face may easily disturb bedding or sheets, especially if the catheter extends downward from the patient interface during use. Forms of this technology that include patient interfaces with a connection port positioned above the patient's head during use can make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: a side-lying position, a supine position (e.g., back down, generally face up), or a prone position (e.g., body front down, generally face down). Furthermore, connecting the catheter to the front portion of the patient interface may exacerbate a problem known as tube resistance, where the catheter exerts undesirable forces on the patient interface during head movement or catheter movement, causing displacement away from the face. Tube resistance may be less problematic when forces are received in a position above the patient's head rather than near the sealing structure in front of the patient's face (where tube resistance is more likely to disrupt the seal).

[0321] 5.3.3.1.4 Fluid Connection of Head Sleeve

[0322] Two tubes 3350 are fluidly connected at their lower ends to an inflation chamber 3200. In some forms of this technology, the connection between the tubes 3350 and the inflation chamber 3200 is achieved through the connection of two rigid connectors. The tubes 3350 and the inflation chamber 3200 can be configured to allow the patient to easily and reliably connect the two components together. The tubes 3350 and the inflation chamber 3200 can be configured to provide tactile and / or auditory feedback in the form of a reassuring click or similar sound, allowing the patient to easily know that each tube 3350 has been correctly connected to the inflation chamber 3200. In one form, the tubes 3350 are formed of silicone or textile material, and the lower end of each silicone tube 3350 is overmolded to a rigid connector made of, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector on each tube 3350 may include a concave engagement structure configured to engage with a convex engagement structure on the inflation chamber 3200. Alternatively, the rigid connector on each tube 3350 may include a convex engagement structure configured to connect to a concave engagement structure on the inflation chamber 3200. In other examples, each tube 3350 may include a convex or concave connector formed of a flexible material, such as silicone or TPE, for example, the same material forming the tube 3350.

[0323] In other examples, compression seals are used to connect each tube 3350 to the inflation chamber 3200. For example, a resilient, flexible (e.g., silicone) tube 3350 without a rigid connector can be configured to be compressed to reduce its diameter, allowing it to be compressed into a port in the inflation chamber 3200, and the inherent elasticity of the silicone pushes the tube 3350 outward to hermetically seal the tube 3350 in the port. Alternatively, in a hard-on-hard engagement between the tube 3350 and the inflation chamber 3200, each tube 3350 and / or inflation chamber 3200 may include a pressure-activated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange can be pushed against the junction between the tube and a circumferential surface around the port or connector of the inflation chamber 3200 to form or reinforce a seal between the tube 3350 and the inflation chamber 3200.

[0324] 5.3.3.2 Headgear

[0325] In some forms, the positioning and stabilizing structure 3300 may include a headgear 3302 with at least one strap, which may be worn by the patient to assist in properly aligning the sealing structure 3100 relative to the patient's face (e.g., to limit or prevent leakage).

[0326] As described above, some forms of the headgear 3302 can be constructed from textile materials that can comfortably conform to the patient's skin. The fabric can be flexible to conform to various facial contours. While the textile may include a hardener along a selected length, this can limit the bending, flexing, and / or stretching of the headgear 3302.

[0327] In some forms, the hood 3302 may be at least partially stretchable. For example, the hood 3302 may comprise an elastic or similar stretchable material. For example, the entire hood 3302 may be stretchable, or selected portions may be stretchable (or stretchable more than the surrounding portions). This may allow the hood 3302 to stretch under tension, which may help provide a sealing force for the seal-forming structure 3100.

[0328] The two types of hoods, the four-point hood 3302-1 and the two-point hood 3302-2, are discussed in more detail below as illustrative examples.

[0329] 5.3.3.2.1 Four-point connection

[0330] like Figure 6E As shown, some forms of the headgear 3302-1 can be a four-point connection headgear. This means that the headgear 3302-1 can be attached to four separate locations on the inflation chamber 3200, on the frame of the inflation chamber 3200, and / or on the arm of the inflation chamber 3200. The headgear 3302-1 may include four different straps that provide tension to help hold the sealing formation 3100 in the sealed position. Figure 3A The positioning and stabilization structure 3300 can also be regarded as a four-point connector headgear.

[0331] In some forms, the headgear 3302-1 may include a lower strap 3304-1 that can be attached to the lower part of the padding 3050-1. The lower strap 3304-1 may extend along the patient's cheek toward the back of the patient's head. For example, the lower strap 3304-1 may cover the masseter muscle on either side of the patient's face. Thus, the lower strap 3304-1 may contact the patient's head below the ears. The lower strap 3304-1 may meet at the back of the patient's head and may cover the occipital bone and / or the trapezius muscle.

[0332] The headgear 3302-1 may also include an upper bandage 3305-1 that may cover the temporal bone, parietal bone, and / or occipital bone. The upper bandage 3305-1 may also be connected to the tube 3350 (e.g., by connection to the flap 3320).

[0333] The posterior bandage 3307-1 may extend between the upper bandage 3305-1 and the lower bandage 3304-1. The lower bandage 3304-1 and the upper bandage 3305-1 on a given side (e.g., left or right) may also be connected adjacent to each other to the posterior bandage 3307-1. Therefore, the height of the posterior bandage 3307-1 may be approximately the combined height of the lower bandage 3304-1 and the upper bandage 3305-1. The posterior bandage 3307-1 may cover the occipital and / or parietal bones during use. This allows the posterior bandage 3307-1 to help anchor the headgear 3302-1 to the patient's head.

[0334] In the illustrated example, the headgear 3302-1 can be formed in a generally X shape. The lower strap 3304-1 and the upper strap 3305-1 can be attached to the rear strap 3307-1 using sewing, ultrasonic welding, or any similar process.

[0335] In some forms, the lower strap 3304-1 can be connected to a portion of the headgear connector, which can be exemplary snap fasteners 3800-1, 3800-2, 3800-3, 3800-4, 3800-5, 3800-6 of the present technology, described in more detail below (see example...). Figure 7E , Figure 8 , Figure 9F , Figure 10C , Figure 11B and Figure 12A For example, each lower strap 3304-1 can pass through buckles 3800-1, 3800-2, 3800-3, 3800-4, 3800-5, 3800-6, allowing the length of each lower strap 3304-1 to be adjusted. Buckles 3800-1, 3800-2, 3800-3, 3800-4, 3800-5, 3800-6 can be removably connected to exemplary retainers 3700-1, 3700-1, 3700-2, 3700-3, 3700-4, 3700-5, 3700-6 of this technology (see example...). Figure 7B , Figure 7Q , Figure 8 , Figure 9B , Figure 10B , Figure 11B and Figure 12A This allows the lower strap 3304-1 to be disconnected from the inflation chamber 3200 without affecting the length of the lower strap 3304-1. For example, the buckle 3800-1 includes, for example, the following features: Figure 7EAs shown in the crossbar 7504, a strap (such as a lower strap 3304-1) can pass through the crossbar to secure the snap fastener 3800-1 to the crossbar. In other aspects, instead of the crossbar 7504, the snap fastener 3800-1 may include one or more slots or other suitable mechanisms through which the strap can pass to or around to secure the snap fastener 3800-1 to the slots or other suitable mechanisms. In further examples, any snap fastener described herein may include a slider connected to a base, such as... Figures 10A to 10H The depicted buckle 3800-4 includes slider 10570 and base 10512.

[0336] In some configurations, the upper strap 3305-1 can be directly connected to the tab 3320 of the tube 3350. The upper strap 3305-1 can pass through the tab 3320 to adjust the length and control the tension of each upper strap 3305-1.

[0337] In some forms, the hood 3302-1 can be used only with the nose and mouth pad 3050-1 (e.g., because the nose pad 3050-1 alone does not have four connection points). However, the hood 3302-1 can be used with... Figure 6D The tube 3350 and hardener arm 3340 shown are interchangeable.

[0338] 5.3.3.2.2 Two-point connection

[0339] like Figure 6F As shown, some forms of the headgear 3302-2 can be two-point connected headgears. This means that the headgear 3302-2 can be connected to two separate locations. Figure 3Y The headgear strap 3310 attached to the positioning and stabilizing structure 3300 shown is an example of a two-point connection.

[0340] In some forms of this technology, such as Figure 3Y The positioning and stabilizing structure 3300 shown includes, in addition to the tube 3350, at least one headband 3310 for positioning and stabilizing the seal forming structure 3100 at the entrance of the patient's airway. The patient interface 3000 includes the band 3310 forming part of the positioning and stabilizing structure 3300. For example, the band 3310 may be referred to as a dorsal band or a posterior headband. The posterior band 3310 may cover the temporal bone, parietal bone, and / or occipital bone.

[0341] More specifically, further reference Figure 3YThe positioning and stabilizing structure 3300 includes a strap 3310 that can be connected between two tubes 3350 positioned on each side of the patient's head and around the back of the head, for example, covering the occipital bone of the patient's head or located below the occipital bone during use. The strap 3310 is connected to each tube above the patient's ear. The positioning and stabilizing structure 3300 may include a pair of tabs 3320. During use, the strap 3310 can be connected between the tabs 3320. The strap 3310 can be flexible enough to wrap around the back of the patient's head and rest comfortably against the patient's head, even under tension during use.

[0342] In other examples of this technology, one or more additional straps may be provided. For example, a patient interface 3000 with a nasal and oral liner according to an example of this technology may have a second lower strap configured to abut against the patient's head near the patient's neck and / or against the posterior surface of the patient's neck.

[0343] Go to Figure 6F In some forms of this technology, the headgear 3302-2 can be formed from a continuous sheet of material. In other words, the headgear 3302-2 may not be formed from multiple straps connected (e.g., sewn) together. This may be comfortable for the patient, as they will not come into contact with any seams or joints connecting the different straps. In other forms, the headgear 3302-2 can be formed from multiple straps connected (e.g., by sewing, ultrasonic welding, etc.) together (e.g., two upper straps, a back strap, etc.).

[0344] like Figure 6F As shown, some forms of the headgear 3302-2 can be at least partially bifurcated. For example, the rear strap 3307-2 of the headgear 3302-2 (e.g., configured to contact the rear portion of the patient's head) can be wider than the surrounding portion of the headgear 3302-2. The middle section 3308-2 of the rear strap 3307-2 may include a slit 3309-2. Thus, due to the slit 3309-2, the upper section of the rear strap 3307-2 can move relative to the lower section. This can allow for greater strap coverage over the rear region of the patient's head, which can help to better anchor the headgear 3302-2 to the patient's head, since there is no lower strap (e.g., 3304-1).

[0345] In some configurations, the headgear 3302-2 can be used only with the nose pad 3050-2 (e.g., because the nose pad 3050-1 does not have four connection points). However, the headgear 3302-2 can be used interchangeably with the tube 3350 and the hardener arm 3340.

[0346] 5.3.3.3 Connection Points

[0347] In some forms of this technology, the patient interface may include a connection point where a connecting member (such as a retainer for a headgear connector) can be located. This connection point may define a location on the patient interface to which a headgear (e.g., headgear 3302-1, 3302-2) is anchored, thereby securing the patient interface to the individual. The location and form of this connection point may vary at least in part depending on the structural features of the inflation chamber and / or components extending from and attached to the inflation chamber, or the type of patient interface to which the connection point is located.

[0348] As will be understood by those skilled in the art, the configuration of the connection point may depend at least in part on the type of connector components that can be used (e.g., mechanical fasteners, adhesives, hook and loop materials, etc.). In one or more forms of this technology, the connecting member may include one of the exemplary retainers 3700-1, 3750-1, 3700-2, 3700-3, 3700-4, 3700-5, 3700-6 described herein or the exemplary snap-fit ​​3800-1, 3800-2, 3800-3, 3800-4, 3800-5, 3800-6.

[0349] The configuration of the connection point can depend at least in part on other components incorporated into the patient interface, and consequently, at least in part on the manner in which air is delivered to the patient (how the patient comfortably receives pressurized air). Air can be delivered to the patient in one of two main ways. In one example, the patient can deliver air through tubes 3350, 3350-3 (see, for example...). Figure 3Y , Figure 6F (Figures 7 and 11) The patient receives a pressurized airflow. This can be referred to as a "tube-up" configuration, and the connection port can be positioned at the top of the patient's head. In other examples, the patient can receive the airflow through a catheter connected to the inflation chamber 3200 (e.g., through connection port 3470 (see example...)). Figure 3A and Figure 3Y It receives a pressurized airflow. This can be referred to as a "tube down" configuration, where the airflow duct is positioned in front of the patient's face.

[0350] Different patients may find one style of air delivery more comfortable than another (e.g., due to the patient's sleeping pattern). Therefore, it may be beneficial to allow the use of a single style of patient interface in either a "tube-up" or "tube-down" configuration. Even with a single style, aspects of the connection point (such as its location, configuration, and the components providing the connection point) may vary due to the configuration of the air chamber and / or components attached to it.

[0351] 5.3.3.3.1 Catheter sleeve

[0352] In some configurations, a sleeve 3351 providing the connection point can be used with the tube 3350 and / or the hardener arm 3340. The sleeve 3351 may at least partially surround the tube 3350 and / or the hardener arm 3340. For example... Figure 6G and Figure 6H As shown, sleeves 3351 of different shapes can be used.

[0353] like Figure 6G As shown, some forms of the catheter sleeve 3351 may include a lower extension 3354. The lower extension 3354 may be positioned on the end of the catheter sleeve 3351 opposite to the upper opening 3352 and define a connection point 3356.

[0354] like Figure 6G As shown, the lower extension 3354 may include a connection point 3356 where a connecting member (such as a retainer for a headgear connector) may be located. As discussed above, the connecting member may be one of several types of connector components (e.g., mechanical fasteners, adhesives, hook and loop materials, etc.). The connection point 3356 may be located at the end of the lower extension 3354, although the connection point 3356 may alternatively be positioned at different locations along the lower extension 3354. The sleeve 3351 may be customized to fit the face of a particular user. For example, the lower extension 3354 of the sleeve 3351 may be constructed in a relatively posterior or anterior region of the patient's head.

[0355] In some configurations, the catheter sleeve 3351 provides additional connection points for attaching, for example, a four-point headgear 3302-1 (although other types of connectors besides the catheter sleeve 3351 may be used). For example, at connection point 3356, a lower strap 3304-1 may be removably attached to the catheter sleeve 3351 (e.g., via headgear connectors 3600-1, 3650-1, 3600-2, 3600-3, 3600-4, 3600-5, 3600-6). In use, each lower strap 3304-1 may contact the patient's cheek (e.g., covering the masseter muscle). The lower strap 3304-1 may also extend below the patient's ear.

[0356] In some forms, the catheter sleeve 3351 can be used with the tube 3350 to allow the patient to experience a "tube-up" air delivery method with the naso-oral pad 3050-1. More specifically, in some forms, the catheter sleeve 3351 may include an upper opening 3352 located at one end of the catheter sleeve 3351. The upper opening 3352 may be an opening in a channel extending along at least a portion of the catheter sleeve 3351. In the illustrated example, the catheter sleeve 3351 can be connected via the upper opening 3352 to the tube 3350 of the positioning and stabilizing structure 3300, such as... Figure 6H As shown.

[0357] 5.3.3.3.2 Conduit Connector

[0358] Figure 7A A patient interface 3000-3 including catheter connectors 3500 is shown, which provide connection points 3356-3. A headgear connector 3600-2 is incorporated into these connection points to operatively connect a lower strap 3304-3 to an inflation chamber 3200-3 / sealing formation.

[0359] and Figure 6H Similar to the catheter sleeve 3351 of the patient interface 3000-1, the catheter connector 3500 connects the tube 3350 to the inflation chamber 3200-3 to provide a pressurized airflow to the inflation chamber 3200-3. The catheter connector 3500 can provide other functions, such as providing ventilation to the patient interface and preventing asphyxiation by including an anti-asphyxiation valve 3525, and connecting to the positioning and stabilization structure 3300.

[0360] Regarding the positioning and stabilizing structure 3300, the conduit connector 3500 may be formed with a flange 3550. The flange 3550 may be integrally molded with the conduit connector 3500. Similar to... Figure 6H The lower extension 3354 of the patient interface 3000-1, flange 3550 may define or otherwise provide connection points 3356, wherein retainers (e.g., one of retainers 3700-1, 3750-1, 3700-2, 3700-3, 3600-4, 3600-5, 3600-6) of the headgear connector (e.g., one of the headgear connectors 3600-1, 3650-1, 3600-2, 3600-3, 3700-4, 3700-5, 3700-6) are located at these connection points. Connection point 3356 may include a concave engagement structure or a convex engagement structure (not shown), which may: (1) be formed on or otherwise provided by the flange 3550; and (2) be configured to be formed by another convex engagement structure or concave engagement structure of retainer 3700-1 (e.g., Figure 7B , Figure 8 and Figure 9D The third joint structure 7004) can be releasably joined.

[0361] As described above, the catheter sleeve 3351 and the catheter connector 3500 can provide a connection point 3356 in which a retainer (such as...) can be incorporated. Figure 7A , Figure 7Q , Figure 8 , Figure 9B , Figure 10A , Figure 11B and Figure 12A The exemplary retainers shown are one of the retainers 3700-1, 3750-1, 3700-2, 3700-3, 3700-4, 3700-5, and 3700-6. As described in more detail below, one or more types of retainers according to the present technology can be configured to be connected to (or have been connected to) a corresponding snap, such as... Figure 7A , Figure 8 , Figure 9F , Figure 10C , Figure 11B and Figure 12A The exemplary snap fastener shown is one of the snap fasteners 3800-1, 3800-2, 3800-3, 3800-4, 3800-5, or 3800-6. This corresponding snap fastener can be used with... Figure 6E The four-point headgear 3302-1 shown Figure 6F The two-point headgear 3302-2 shown or other suitable headgear integration. Although for ease of explanation, this disclosure describes a retainer incorporated at connection point 3356 and a snap fastener integrated with the headgear, it is contemplated that the retainer and snap fastener (i.e., engagement portion) of the headgear connector may be in a relative orientation, provided that they are configured to engage with each other to secure the patient interface to the patient.

[0362] 5.3.3.4 Headgear Connector

[0363] When a patient interface is worn, a seal is formed between the sealing structure and the area of ​​the patient's face adjacent to the patient's airway. As pressurized air flows through the patient interface, this seal tends to be pushed away from the patient's face. To counteract this tendency, a counterforce is applied to the seal to help maintain its position relative to the patient's face. In addition to maintaining a proper seal with the patient's face, patients may also expect the patient interface to be easy to remove. Furthermore, integrating a patient interface with an air delivery catheter, constructed to be stable and maintain sufficient force, can reduce the complexity of attaching the patient interface to the patient, thereby improving patient adherence to therapy.

[0364] The headgear connector described herein may provide an alternative connector solution that utilizes a magnet (or more generally, magnetic force) to provide secure attachment between a component forming a sealed structure (e.g., a frame, an inflation chamber) and a headgear component (e.g., a strap, such as a lower strap). More specifically, in the absence of a magnet, magnetic component, or otherwise relying on magnetic force, the exemplary headgear connector according to this disclosure is configured to: maintain a desired seal with the patient's face; facilitate attachment and removal of the patient interface; and prevent accidental loosening or detachment of the patient interface from the patient's face.

[0365] Those skilled in the art will recognize that, in some forms, the various components of the headgear connector according to the present technology (e.g., retainers, snaps, engagement structures, receptacles) may be made at least partially of a material (e.g., metals, metal composites) capable of responding to the magnetic properties of another object (e.g., being attracted), and are still considered not to include magnets, magnetic components, or otherwise rely on magnetic force to provide the secure attachment as discussed above. Furthermore, in some forms, the various components of the exemplary headgear connector of the present technology (e.g., retainers, snaps, engagement structures, receptacles) may be formed of a material having magnetic properties / characteristics (the amount of which does not cause the component as a whole to exhibit such magnetic properties), and are still considered not to include magnets, magnetic components, or otherwise rely on magnetic force to provide the secure attachment as discussed above. Moreover, while the various components of the headgear connector described herein may be described as alternatives to a magnetic headgear connector, it is conceivable that the headgear connector of the present technology may optionally include magnetic materials, thereby allowing for the simultaneous use of both mechanical and magnetic fastening mechanisms.

[0366] Therefore, the headgear connector according to this technology can be used for a wider range of patients, including those who do not wish to have magnets on or near their face.

[0367] like Figures 7A to 12B As shown, different headgear connectors 3600-1, 3650-1, 3600-2, 3600-3, 3600-4, 3600-5, and 3600-6 of one or more forms according to the present invention can be incorporated into various patient interfaces 3000-3, 3000-4, 3000-5, or other suitable patient interfaces of one or more forms according to the present invention.

[0368] 5.3.3.4.1 Lever and Support Surface Mechanism

[0369] Figure 7A A patient interface 3000-3, comprising a headgear connector 3600-1, is shown in one form according to the present technology. Figure 7B , Figure 7C and Figure 7D Top perspective view, side perspective view and bottom perspective view of retainer 3700-1 of headgear connector 3600-1 according to one form of the present technology are shown respectively. Figure 7E , Figure 7F and Figure 7GTop, bottom, and side perspective views of the snap-fit ​​3800-1 of one form of headgear connector 3600-1 according to the present technology are shown respectively. As described in more detail below, the snap-fit ​​3800-1 is configured to engage and secure to the retainer 3700-1 according to an engagement type, which may be mechanical and in some respects may be devoid of any magnetic components. Figure 7A As shown, the snap fastener 3800-1 may include text or other markings (e.g., texture, color coding, symbols, or other visual markings, or combinations thereof) to indicate to the user the type of headgear connector 3600-1 used with the patient interface 3000-3. For example, as... Figure 7A As shown, the text indicates that connector 3600-1 is a non-magnetic connector 3600-1. Alternatively, connector 3600-1 may include a mark indicating that connector 3600-1 is a magnetic connector. Such a mark allows the user to know whether the patient interface is suitable for their use. Furthermore, it helps the user track the type of connector 3600-1 currently connected to the patient interface 3000-3. For example, in a scenario where the user changes the type of connector 3600-1 attached to the patient interface 3000-3, this mark helps the user track the current type of connector 3600-1 on the patient interface 3000-3. Finally, although... Figure 7A The mark is shown on the outer edge of the snap 3800-1, but the mark may also be located on another part of the snap 3800-1 or on the retainer 3700-1.

[0370] like Figure 7B As shown, the retainer 3700-1 includes a base wall 7008, a first engagement structure 7010, and a rod 7030 extending from the base surface 7008A of the base wall 7008. In one form, the base wall 7008 may be adjacent to a flexible wall 7006, which is adjacent to a frame 7004 on which tab surfaces 7002 are provided. In one example, the frame 7004 may define a receiving space 7004B and a cavity 7004A, as described below. Figure 7K A more detailed description of the interface bonding structure.

[0371] The first engagement structure 7010 may include a base surface 7008A, an extension wall 7012 extending from the base surface 7008A, and a plurality of inserts 7020 extending from the extension wall 7012. The rod 7030 may be part of a convex engagement structure including the extension wall 7012 and the inserts 7020. Each insert 7020 may include: a riser 7022 extending from the extension wall 7012; an outwardly projecting ridge 7024 on a side opposite to the rod 7030; and an inclined surface 7026 extending from the ridge 7024. Figure 7BAs shown, the rod 7030, the extension wall 7012, and the base surface 7008A can be arranged concentrically relative to each other. In some exemplary forms of the first engagement structure 7010 of this technology, the insert 7020 and more specifically the riser 7022 can extend from the base surface 7008A, such that the extension wall 7012 is absent or has a shorter extension wall 7012.

[0372] like Figure 7C and Figure 7D As shown, the base wall 7008 can define a notch or cavity 7040. For example... Figure 7K As shown, the cavity 7040 can extend as a probe hole 7042 formed within the rod 7030. Because of the inclusion of the probe hole 7042, less material can be used to construct the retainer 3700-1, making the retainer 3700-1 lighter than if the probe hole 7042 were not constructed. Alternatively, the base wall 7008 may not define a cavity, and the rod 7030 may be solid rather than hollow. On the other hand, the base wall 7008A may define a notch, and the rod 7030 may be solid rather than hollow.

[0373] In some forms of this technology, the first engagement structure 7010 may include four posts 7020 equidistantly spaced around the rod 7030, such as Figures 7H to 7J As shown. However, those skilled in the art will understand that the first engagement structure 7010 may include different numbers of inserts 7020 in different arrangements, such as two, three, five or more inserts 7020. In other forms, the inserts 7020 may be provided by a single cylindrical wall extending from the extension wall 7012 and including a riser 7022, a ridge 7024, and an inclined surface 7026. The arrangement of the implementation of the first engagement structure 7010 may correspond to the arrangement of the receiver 7520 located on the snap 3800-1, an exemplary version of which is shown below. Figures 7E to 7G As illustrated. Together with connecting wall 7506 and end face 7508 (see example...) Figure 7F The receiver 7520 defines a second engagement structure 7510 located on the snap 3800-1.

[0374] like Figure 7E As shown, the snap fastener 3800-1 includes a receiver 7520 that defines an opening 7530 disposed between a proximal surface 7500A and an intermediate wall of the snap fastener 3800-1. The opening 7530 is configured to receive at least a portion therein of a first engagement structure 7010 to allow the snap fastener 3800-1 and the retainer 3700-1 to engage with each other. In one form of the present technology, the receiver 7520 includes: a first surface 7522; a second surface 7524; and a receiver transition portion 7528 formed between or otherwise disposed between the first surface 7522 and the second surface 7524 (see, for example...). Figure 7K The opening 7530 may be defined by the receiver 7520 and the second body 7500 of the latch 3800-1. A portion of the receiver 7520, including the first surface 7522, may be inclined to form a tapered or converging structure. A portion of the receiver 7520, including the second surface 7524, may be configured to surround the inclined surface 7026 of the post 7020 when engaged between the ridge 7024 of the post 7020 and the protruding edge of the receiver transition portion 7528 of the receiver 7520.

[0375] like Figure 7F and Figure 7G As shown, the connecting wall 7506 can extend from the proximal surface 7500A of the snap fastener 3800-1 to the opening 7530. The connecting wall 7506 and the third surface 7526 of the receiver 7520 can surround the opening 7530. The third surface 7526 can be disposed on the side of the opening 7530 opposite to the connecting wall 7506. Although the third surface 7526 is described in this embodiment, it may not be included depending on how the snap fastener 3800-1 is formed. For example, the space surrounding the third surface 7526 can be filled depending on how the body of the snap fastener 3800-1 is formed.

[0376] Alternative versions of the near-side surface 7500A, such as Figures 7U to 7W As depicted. In this version, the proximal surface 7500A can protrude inward toward the opening 7530 and then away from it. Figure 7A The outer or upper surface of the shown latch 3800-1 extends. Thus, the proximal surface 7500A can form a lip 7580 overhanging the ridge 7585, which allows the user's fingers to more easily engage the proximal surface 7500A to lift the proximal portion of the latch 3800-1 upwards away from the retainer 3700-1, thereby releasing the latch 3800-1 from the retainer 3700-1, for example, to remove the patient interface 3000-3. In other respects, forming the lip 7580 and ridge 7585 on the proximal surface 7500A can also indicate the correct orientation of the latch 3800-1 to the user. Since the lip 7580 and ridge 7585 allow the user to more easily release the latch 3800-1 from the retainer 3700-1, it may be more intuitive for the user to position the latch 3800-1 above the retainer 3700-1, so that the lip 7580 of the proximal surface 7500A is furthest from the body 7000-1 of the retainer 3700-1, while the ridge 7585 is positioned relatively closer to the body 7000-1, such as... Figure 7Z As shown. Furthermore, the protruding lip 7580 provides a contact point for the user to press down, thereby securing the clip 3800-1 to the retainer 3700-1. This prevents the user from placing the clip 3800-1 upside down on the retainer 3700-1.

[0377] like Figure 7X and Figure 7Y As shown, ridge 7585 can extend evenly around the proximal and lateral portions of buckle 3800-1. Figure 7Y Alternatively, it can extend at a certain angle on each side portion of the 3800-1 clip. Figure 7X For example, ridge 7585 may reach its lowest point at the nearest end of snap fastener 3800-1 and may extend upward as it surrounds the side of snap fastener 3800-1. If ridge 7585 extends substantially uniformly around the near and side portions of snap fastener 3800-1, then lip 7580 may have substantially similar thickness overall. If ridge 7585 extends at an angle as it surrounds the side of snap fastener 3800-1, then the thickness of lip 7580 within its nearest end may be greater than its thickness within its farthest end along the side of snap fastener 3800-1.

[0378] In the illustrated example, the post 7020 of the retainer 3700-1 is formed or otherwise provided with a ridge 7024, and the receiver 7520 of the latch 3800-1 is formed or otherwise provided with a receiver transition portion 7528, which includes a protruding edge in the form of a ridge. The outwardly projecting ridge 7024 of the post 7020 surrounding the rod 7030 of the retainer 3700-1 can form an imaginary circle with a diameter larger than the diameter of the opening 7530 of the latch 3800-1 at the receiver transition portion 7528. In other forms of the art, the protruding feature of the post 7020 can alternatively be provided as a protrusion having a shape such as a bump, and the receiver transition portion 7528 can provide the features mentioned above and as... Figure 7K The protruding edge is shown. Alternatively, the receiver transition portion 7528 may include a series of notches formed according to the contour of a protrusion (e.g., a bump) projecting from the post 7020. Accordingly, in the context of the first and second engagement structures described in this disclosure, protrusions (such as bumps) may be used or otherwise provided in place of ridges or protruding edges (or vice versa), and one or more notches may be used or otherwise provided in place of grooves (or vice versa).

[0379] Furthermore, when describing two engagement structures (e.g., snap-fit ​​3800-1 and receiver retainer 3700-1), ridges, ramps, recesses, protrusions, or other features on one structure (e.g., post 7020) may be interchanged with ridges, ramps, recesses, protrusions, or other features on the opposite structure (e.g., receiver 7520). In the combination of engagement structures described herein, including a protruding structural element (e.g., ridge, edge, post, etc.) and a recess or other receiving structural element (e.g., notch, receiving space, slot, etc.), these structural elements may be interchanged. More specifically, a first component (e.g., a retainer) including a protruding structural element may be provided in the form of a corresponding receiving structural element. Thus, a second component (e.g., a snap-fit) including a receiving structural element corresponding to the protruding structural element of the first component may be provided in the form of a corresponding protruding structural element.

[0380] Figures 7H to 7J A headgear connector 3600-1 in multiple engagement states, according to the present technology, is shown. More specifically, Figure 7H The disengaged state of the headgear connector 3600-1 is illustrated, with the latch 3800-1 positioned above the retainer 3700-1. In one example, Figure 7H The example illustrates a snap-fit ​​3800-1 in an exemplary position relative to the retainer 3700-1, such that the second engagement structure 7510 is prepared to engage with the first engagement structure 7010. In one example, this may include the rod 7030 being substantially spatially aligned with the central region of the opening 7530. In this alignment, the snap-fit ​​3800-1 can move toward the retainer 3700-1 and engage with... Figure 7I The position corresponding to the first part of the engagement state shown.

[0381] Figure 7H Examples are given by Figures 7A to 7P One aspect of the usability level provided by the exemplary headgear connector 3600-1 is that, more specifically, when attempting to attach the snap 3800-1 to the retainer 3700-1, the patient can use the same hand to hold the snap 3800-1 and position the retainer 3700-1 and its engagement structure. That is, the patient can use a finger that does not touch the snap 3800-1 to search for and position the pin 7020 or lever 7030 of the retainer 3700-1 without much effort. Furthermore, the patient can use the pin 7020 or lever 7030 to guide the movement of the snap 3800-1 generally toward the retainer 3700-1, and specifically to engage with the retainer.

[0382] The patient's ability to perform the aforementioned actions using one hand can be attributed to the easily identifiable shape and elevated position of both the post 7020 and the rod 7030 relative to the remainder of the retainer 3700-1, and the sealing formation of a patient interface (such as patient interface 3000-3 (or other suitable patient interface)) to which the retainer 3700-1 can be attached. Furthermore, the exposed surface 7032 of the rod 7030 can be formed by one or more structural elements (such as pits, bumps, grooves, notches, serrations, ridges, knurling, and textures) to enhance the uniqueness of the sensation when touching the rod 7030. One or more of these structural elements can be additionally or alternatively incorporated into other parts of the retainer 3700-1, such as the first body 7000. For example, Figure 7A and Figure 7B A protrusion is depicted on the first body 7000. The snap 3800-1 may also additionally or alternatively include one or more structural elements, which may be different from or the same as the structural elements incorporated on the retainer 3700-1. Accordingly, it can accommodate some patients who may have difficulty grasping objects due to dexterity issues. That is, these patients can also be able to perform the operation of engaging the snap 3800-1 to the retainer 3700-1 with one hand without too much difficulty, as the patient will be able to identify the different surfaces of the post 7020 and / or the rod 7030. The shape of one or more of the connecting wall 7506, the end face 7508, and the first surface 7522 can also facilitate the engagement of the snap 3800-1 with the retainer 3700-1. For example, these structures may form a widened entrance to the opening 7530, which gradually decreases or otherwise narrows inward to help orient the post 7020 within the opening 7530. While these features facilitate single-handed use, two-handed use is also conceivable.

[0383] Figure 7I A headgear connector 3600-1 in a partially engaged state is shown. The posts 7020 may be formed of a material that allows the posts 7020 to deflect toward and away from the rod 7030. In some respects, the posts 7020 may be spaced apart from the rod 7030. If a force is applied to the posts 7020, these posts may deflect inward toward the rod 7030. Once the force is removed, the posts 7020 may return to their original position. For example, during engagement of the latch 3800-1 with the retainer 3700-1, when the posts 7020 engage with the opening 7530, such as when the inwardly projecting portion of the receiver 7520 moves past the outwardly projecting portion of the posts 7020 to engage with the retainer 3700-1, these posts may deflect inward. The deflectability of the insert 7020 facilitates the engagement and / or fixation of the snap-fit ​​3800-1 and retainer 3700-1. Figure 7IIn the illustrated position, the ridge 7024 of the insert 7020 can engage with the receiver conversion part 7528. In one example, this engagement state can correspond to a point during the engagement process just before or at which the insert 7020 begins to retract toward the rod 7030.

[0384] As will be appreciated by those skilled in the art, the inward deflection of the insert 7020 can continue as the latch 3800-1 moves toward the base surface 7008A of the retainer 3700-1 until the receiver conversion part 7528 moves below the ridge 7024 of the insert 7020. However, when the receiver conversion part 7528 engages with the base of the ridge 7024 (e.g., Figure 7K As shown, when the material bias of the insert 7020 causes it to open outward and return to its original position, the ridge 7024 of the insert 7020 can be securely positioned within the receiver 7520 above the receiver conversion section 7528, and as shown... Figure 7J As shown, the clip 3800-1 can be securely attached to the retainer 3700-1.

[0385] Figure 7I and Figure 7J Additional exemplary aspects attributable to the availability of the exemplary headgear connector 3600-1 are also demonstrated. Specifically, the engagement between the first engagement structure 7010 and the second engagement structure 7510 can be achieved by moving the snap 3800-1 toward the base surface 7008A of the retainer 3700-1. Furthermore, the angle of the first surface 7522 of the receiver 7520 of the snap 3800-1 allows for a slight deviation in the perfect alignment of the central region of the rod 7030 and the central region of the opening 7530 without hindering the patient from... Figure 7H The disengaged state shown enters Figure 7I The partial engagement state shown and from Figure 7I The partial engagement state shown enters Figure 7J The ability to engage in the indicated engagement state. In particular, when in contact with the insert 7020, the tilt of the first surface 7522 of the receiver 7520 can guide the latch 3800-1 to move to a sufficiently aligned position so that the receiver conversion part 7528 engages the insert 7020.

[0386] As described above, the exemplary opening 7530 and exemplary pin 7020 can facilitate engagement even when there is no perfect alignment between the central region of the rod 7030 and the opening 7530. As illustrated, the opening 7530 is provided with a circular configuration, and the pin 7020 has a corresponding circular arrangement. However, those skilled in the art will recognize that other shapes can serve as the basis for the design of the engagement components of the headgear connector 3600-1. Such flexibility can be achieved in part through the inclined configuration of the first surface 7522. The receiver 7520 can provide a concave engagement structure for the headgear connector 3600-1, which can be incorporated into the second engagement structure 7510 of the snap 3800-1 (as shown) or the first engagement structure 7010 of the retainer 3700-1. In the former case, the first surface 7522 of the receiver 7520 can guide the snap 3800-1 away from and relative to the pin 7020. In the latter case, the angle of the first surface 7522 can guide the movement of the latch 3800-1 by acting as a funnel and guiding the movement of the insert 7020 relative to the receiver 7520 incorporated in the retainer 3700-1 and the receiver conversion part 7528 toward the receiver.

[0387] The retainer 3700-1 and the snap fastener 3800-1 may be formed of different materials or they may be formed of the same material. Additionally, different parts of the retainer 3700-1 and the snap fastener 3800-1 may be formed of the same material or different materials.

[0388] Retainer 3700-1 may be formed of a plastic (e.g., thermoplastic polyester elastomer (TPE), which has less stiffness than snap fastener 3800-1). In some forms, retainer 3700-1 may be formed of TPE such as HYTREL manufactured by DuPont (including products sold under this trademark, such as Hytrel 7246). In other forms, retainer 3700-1 may more generally be formed of a material having specific mechanical properties (e.g., a tensile modulus of approximately 525 MPa, a flexural modulus of approximately 550 MPa, and a nominal Shore D hardness of approximately 72D). Any of the other exemplary retainers 3750-1, 3700-2, 3700-3, 3700-4, 3700-5, and 3700-6 described may be formed of the material identified above or a material having the material properties identified above.

[0389] In one example, the snap fastener 3800-1 can be formed from a plastic material (such as a thermoplastic polymer, like polycarbonate). In some forms, the snap fastener 3800-1 can be formed from polycarbonate materials such as MAKROLON manufactured by Bayer Material Science (including products sold under this trademark, such as Makrolon 2458). In other forms, the snap fastener 3800-1 can more generally be formed from materials with specific mechanical properties (such as a tensile modulus of approximately 2400 MPa, a flexural modulus of approximately 2350 MPa, and a ball indentation hardness of approximately 115 N / mm²). 2 The material formed of the snap fastener. Any of the other exemplary snap fasteners 3800-2, 3800-3, 3800-4, 3800-5, 3800-6 described herein may be formed from the material identified above or a material having the material properties identified above.

[0390] Figure 7J An example of the engagement state of the headgear connector 3600-1 is shown. In the illustrated example, the opening 7530 is substantially circular, and the ridges 7024 are combined to form a shape profile corresponding to the circumference of the circle. Therefore, the engagement between the ridges 7024 and the receiver transition portion 7528 can be characterized as a ring-shaped interlocking mechanism. However, those skilled in the art will understand that other shapes can provide a template for the configuration of the post 7020 and the receiver 7520.

[0391] accomplish Figures 7H to 7J The actions described (especially from) Figure 7H Partial engagement state moved to Figure 7J The force required for the engagement state can be less than about 40.0 N, less than about 35.0 N, less than about 30.0 N, less than about 25.0 N, less than about 20.0 N, less than about 15.0 N, less than about 10.0 N, or less than about 5.0 N. For example, the mating force can be about 1.0 N to about 10.0 N, about 5.0 N to about 10.0 N, about 1.0 N to about 15.0 N, or about 1.0 N to about 30.0 N. These force characteristics for the engagement between the parts of the head sleeve connector are generally applicable to other exemplary head sleeve connectors of this technology, including, for example, head sleeve connectors 3650-1, 3600-2, 3600-3, 3600-4, and 3600-5 described below.

[0392] Remove or disconnect the clip 3800-1 from the retainer 3700-1 (i.e., from...). Figure 7J Move to Figure 7I and Figure 7HThe required force can be: less than about 60.0 N, less than about 55.0 N, less than about 50.0 N, less than about 45.0 N, less than about 40.0 N, less than about 35.0 N, less than about 30.0 N, less than about 25.0 N, less than about 20.0 N, less than about 10.0 N, or less than about 5.0 N. For example, the removal force can be: about 1.0 N to about 60.0 N, about 5.0 N to about 50.0 N, about 5.0 N to about 45.0 N, about 5.0 N to about 40.0 N, about 5.0 N to about 35.0 N, about 5.0 N to about 30.0 N, about 5.0 N to about 25.0 N, about 5.0 N to about 20.0 N, about 5.0 N to about 15.0 N, or about 5.0 N to about 10.0 N. These force characteristics for removing / disengaging the parts of the headgear connector can generally be applied to other exemplary headgear connectors of this technology, including, for example, headgear connectors 3650-1, 3600-2, 3600-3, 3600-4 and 3600-5 described below.

[0393] Regarding further availability, feedback can be used to indicate the engagement or disengagement of the snap fastener 3800-1 and retainer 3700-1. This feedback sends a signal to the patient notifying them that the snap fastener 3800-1 and retainer 3700-1 are engaged, disengaged, or indicating either condition. For example, when removing the snap fastener 3800-1 from... Figure 7I The first part of the engagement state shown moves to Figure 7J In the exemplary engaged state, the insert 7020 can be engaged above the receiver transition portion 7528 and within a portion of the opening 7530 surrounded by the second surface 7524. This can generate one or both auditory and tactile feedback to the patient. The engagement of the insert 7020 within the space surrounded by the second surface 7524 can produce a clicking sound, which can serve as notification that engagement has been completed. Regarding tactile feedback, the patient can feel the resistance exerted by the receiver transition portion 7528 on the inclined surfaces 7026 and ridges 7024 of the insert 7020, and the resulting residual movement of the insert 7020 or the vibrations caused thereby. Additionally or alternatively, the patient can feel the impact of the connecting wall 7506 and / or the first end face 7508 being positioned on the base surface 7008A, such as... Figure 7K As shown. When the latch 3800-1 and retainer 3700-1 are disengaged, the reverse interaction can similarly provide one or both of auditory and tactile feedback.

[0394] Figure 7K It shows from and Figure 7J The plane corresponding to line 7K-7K in the middle faces as follows Figure 7J The cross-sectional view of the headgear connector 3600-1 viewed from the indicated direction K. (See diagram below.) Figure 7KAs shown, in the engaged state, the receiver conversion portion 7528 engages with the base of the ridge 7024 of the insert 7020. Furthermore, the inclined surface 7026 of the insert 7020 is surrounded by the second surface 7524 of the receiver 7520. On the other hand, in Figure 7K In the depicted exemplary engagement state, the extension wall 7012 and the riser 7022 may be surrounded by the first surface 7522 of the receiver 7520. As... Figure 7K As shown, in some forms of this technology, the connecting wall 7506 and the first end face 7508 of the receiver can contact the base surface 7008A of the retainer 3700-1.

[0395] Further reference Figure 7K The first body 7000 of the retainer 3700-1 defines a base wall 7008, a flexible wall 7006, and a frame 7004. The base wall 7008 defines a portion of the first body 7000 that supports the first engagement structure 7010, and an area that can be grasped by a person when the retainer 3700-1 is attached to or detached from a patient interface (such as the patient interface 3000-1 shown in FIG. 7). The flexible wall 7006 may have a reduced thickness relative to the base wall 7008 and may act as a bridge between the base wall 7008 and the frame 7004. The frame 7004 defines the interface engagement structure and includes features that allow the retainer 3700-1 to be attached to the patient interface 3000-1.

[0396] In some forms, the reduced thickness of the flexible wall 7006 allows the base wall 7008 to make some elastic movement relative to the frame 7004. In one example, the flexible wall 7006 can bend when a force is applied to the base wall 7008 and the frame 7004 is held in place (or vice versa, when the base wall is held in place and a force is applied to the frame). Therefore, the retainer 3700-1 can buckle (e.g., bend) or otherwise elastically deform during one or more of the following situations: when the retainer 3700-1 is attached to or detached from the patient interface 3000-1; when the snap 3800-1 is attached to or detached from the retainer 3700-1; and, for example, when the patient interface 3000-3 is worn to accommodate patient movement.

[0397] The proximal end of retainer 3700-1 defines a front wall of frame 7004, which extends from and connects to a wall defining tab surface 7002. A support wall may extend from a portion of the proximal wall adjacent to the flexible wall 7006 to the proximal end, thereby closing frame 7004. This support wall may define an engagement member of frame 7004. In one example, the support wall may define a cavity 7004A, which may provide and thus define an interface engagement structure provided by frame 7004 as a concave engagement structure. More specifically, cavity 7004A may be configured to accommodate a convex engagement structure included in a sealing structure or a component attached to the sealing structure. In one example, the convex engagement structure may be accommodated through cavity 7004A to... Figure 7K The frame 7004 shown contains the accommodating space 7004B.

[0398] like Figure 7K As shown, the height of the frame 7004 can be greater than the thickness of the base wall 7008. Therefore, the flexible wall 7006 can be spaced apart from the surface of the component to which the frame 7004 is joined. Thus, when attached to a patient interface (such as patient interface 3000-3), the frame 7004 can provide a fulcrum around which the flexible wall 7006 and the base wall 7008 can move. For example, the frame 7004 can be attached to the patient interface, and the first engagement structure 7010 of the retainer 3700-1 can engage (attach) with the second engagement structure 7510 of the snap fastener 3800-1. In this example, for example along relative to... Figure 7K Applying force to the snap fastener 3800-1 in an upward or downward orientation may cause the flexible wall 7006 to bend or otherwise move. Furthermore, the movement of the flexible wall 7006 and the engagement between the following can cause a combined movement of the base wall 7008 and the snap fastener 3800-1 as a lever: (1) the insert 7020 of the retainer 3700-1; and (2) the receiver 7520 of the snap fastener 3800-1.

[0399] refer to Figure 7Z As illustrated in the example and as described above, the snap fastener 3800-1 may include, in some respects, a lip 7580 that provides a first upper or outer surface for a user to press down when the snap fastener 3800-1 is attached to the retainer 3700-1. The lip 7580 and ridge 7585 (if included) may further provide a second lower surface that a user can apply force with their finger to push or pull the snap fastener 3800-1 away from the retainer 3700-1, thereby releasing the snap fastener 3800-1 from the retainer 3700-1.

[0400] In some respects, one or more portions of the retainer 3700-1 or the snap-fit ​​3800-1 (or both) may include features designed to make the connector 3600-1 easier to clean or less likely to trap debris or bacteria. For example, Figure 7AA The image depicts a bottom view of the Snap 3800-1. The Snap 3800-1 can be designed to omit excessively narrow sections or notches that could become very sharp, in order to prevent debris or bacteria from accumulating in those sections or notches. Narrow sections and notches can also make cleaning more difficult for users, and users who wipe these sections may not be able to effectively clean them regularly. Figure 7AA A design example is depicted that attempts to avoid using a notch that forms a narrow point. Position 7590 depicts a notch in which a second surface 7526 extending around opening 7530 meets the sidewall of snap fastener 3800-1. The shape of position 7590 allows for the absence of a narrow point in the notch between the second surface 7526 and the sidewall of snap fastener 3800-1. For example, position 7590 could be U-shaped at its proximal end, or it could form a flat wall separating the sidewall and the second surface 7526. While position 7590 can be relatively narrower than the surrounding portions, avoiding a notch that forms a narrow point reduces the likelihood of debris or bacteria accumulating at position 7590. Furthermore, users can more easily clean position 7590 by wiping snap fastener 3800-1 or immersing snap fastener 3800-1 in a fluid. By forming a gap between the sidewall and the second surface 7526 located at position 7590, this version of the snap fastener 3800-1 can be made easier to clean. In one example, position 7590 may have a gap width of at least 0.5 mm or at least 1 mm at its narrowest point. For example, the gap width may be about 1 mm to about 2 mm, about 1 mm to about 1.5 mm, or about 1 mm to about 1.3 mm.

[0401] The various headgear connectors described in this article, including Figures 7A to 12B The headgear connectors 3600-1, 3650-1, 3600-2, 3600-3, 3600-4, 3600-5, and 3600-6 described herein offer a favorable level of usability and comfort, particularly in placing the patient interface on the patient and subsequently securing it in a secure, sealed, and appropriate position. Furthermore, the headgear connectors described herein provide patients with the flexibility to choose between different types of face masks and headgear connectors without sacrificing these advantages in usability and comfort.

[0402] More specifically, the headgear connector 3600-1 and headgear connectors 3650-1, 3600-2, 3600-3, 3600-4, 3600-5, and 3600-6 described below may particularly include frame 7004 as an interface engagement structure. Therefore, headgear connectors 3600-1, 3650-1, 3600-2, 3600-3, 3600-4, 3600-5, and 3600-6 can be adapted to existing patient interface models that include a convex engagement structure for the retainer, which is compatible with a concave interface engagement structure version of frame 7004 (see, for example...). Figures 7B to 7D , Figure 7K , Figure 7Z , Figure 8 and Figures 9B to 9D Alternatively, headgear connectors 3600-1, 3650-1, 3600-2, 3600-3, 3600-4, 3600-5, and 3600-6 may include interface engagement structure versions comprising the convex engagement structure mentioned above. Therefore, these versions of headgear connectors 3600-1, 3650-1, 3600-2, 3600-3, 3600-4, 3600-5, and 3600-6 can be adapted to existing patient interface models that include a concave engagement structure for the retainer, which is compatible with the convex interface engagement structure version of frame 7004. Accordingly, headgear connectors 3600-1, 3650-1, 3600-2, 3600-3, 3600-4, 3600-5, and 3600-6 can be readily used as retainers that utilize frame 7004 as the interface engagement structure, replacing magnetic headgear connectors.

[0403] Alternatively, the retainer according to this technology, such as Figures 7A to 12B Exemplary retainers 3700-1, 3750-1, 3700-2, 3700-3, 3700-4, 3700-5, and 3700-6 may include different types of interface engagement structures compatible with various engagement structures included on different types of patient interfaces. For example, certain aspects of a retainer for a "tube-up" patient interface may differ in the shape, size, and type of the interface engagement structure compared to a retainer for a "tube-down" type patient interface. However, these retainers may include the same or similar engagement structures (e.g., convex engagement structures) and are used with snap fasteners 3800-1, 3800-2, 3800-3, 3800-4, 3800-5, and 3800-6 to provide headgear connectors that can be used to replace currently used headgear connectors such as those including magnetic components.

[0404] As described above, the catheter connector 3500 may be formed with a flange 3550 that may define or otherwise include a connection point 3356 for the retainer 3700-1 of the headpiece connector 3600-1. However, in other respects, the flange 3550 may be separable from the catheter connector 3500 and may be present on the patient interface 3000-3, for example, to serve as the connection point 3356, or the connection point 3356 may be located elsewhere outside the flange. The connection point 3356 may include a concave or convex engagement structure (not shown) that may be configured to be releasably engaged by a corresponding convex or concave interface engagement structure (such as the interface engagement structure provided by the frame 7004 of the retainer 3700-1) to secure the retainer 3700-1 to the patient interface 3000-3. In other respects, the retainer 3700-1 may be permanently coupled to the connection point 3356, and in such embodiments, the connection point 3356 may not include mating features.

[0405] The configuration of both the first engagement structure 7010 and the second engagement structure 7510 allows for some rotation of the latch 3800-1 relative to the retainer 3700-1. Such rotation may occur when a patient wears a patient interface (such as patient interface 3000-3), for example, during movement while awake and / or asleep. If the relative rotation of the headband connector 3600-1 is not accommodated, some movement by the patient that could lead to such rotation may result in a certain pulling or other force being applied to the patient by one or more components of the patient interface 3000-3. Furthermore, the patient may experience varying degrees of discomfort if not for the limited rotation between the latch 3800-1 and the headband connector 3700-1 permitted by the headband retainer 3600-1 according to the present technology. In some aspects, if relative rotation between the latch 3800-1 and the retainer 3700-1 is not permitted, the force applied during movement may cause the latch 3800-1 and the retainer 3700-1 to disengage, resulting in accidental loosening or detachment of the patient interface, potentially interrupting the intended delivery of treatment. Therefore, with the specific implementation of the headgear connector 3600, such movement may not be noticed by the patient or usually not be considered a nuisance, and / or the occurrence of accidental loosening or detachment of the patient interface can be reduced.

[0406] Figures 7L to 7P A headgear connector 3600-1, according to one form of the present technology, is shown in various states that result in disengagement during use with a patient interface positioned on a patient. Figure 7L The headgear connector 3600-1 in an engaged state is illustrated, and the rod 7030 and the exposed surface 7032 of the rod 7030 are identified. Figure 7M and Figure 7NAn exemplary headgear connector 3600-1 in an engaged state and an exemplary first-hand position 1005A are illustrated. Figure 7M ), 1005B ( Figure 7N The first finger is 1025 and the second finger is 1035. Figure 7O The headgear connector 3600-1 is shown during the disengagement process. Figure 7P The headgear connector 3600-1 is shown in the disengaged state.

[0407] According to some forms of this technology, the insert 7020 of the headgear connector 3600-1 provides part of an annular engagement mechanism. That is, during engagement with the receiver conversion portion 7528, the insert 7020 can bend and retract inward, and unfold and establish a retaining force once passed through the receiver conversion portion 7528. Successful implementation of the headgear connector 3600-1 balances two aspects: (1) providing sufficient retaining force to withstand patient movement during sleep and maintain engagement; and (2) not having excessive retaining force to avoid making it too difficult for the patient to remove intentionally. A lever 7030 can assist in achieving this balance. The lever 7030 can provide a support surface and a lever point to the patient, which can be used to angle the receiver conversion portion 7528 of the latch 3800-1 against the ridge 7024 of the insert 7020 of the retainer 3700-1 and push the receiver conversion portion away from the ridge (pry open from the ridge). Therefore, the rod 7030 can be used to provide a mechanical advantage to the patient and multiply the force applied by the patient to counteract the holding force of the headgear connector 3600-1.

[0408] In some examples, the engagement between the first engagement structure 7010 and the second engagement structure 7510 can present a removal force corresponding to the force that a patient must apply to disengage the snap 3800-1 from the retainer 3700-1. As described above, disengaging the snap 3800-1 from the retainer 3700-1 (e.g.) Figures 7L to 7P The required force (as shown) can be: less than about 60.0 N, less than about 55.0 N, less than about 50.0 N, less than about 45.0 N, less than about 40.0 N, less than about 35.0 N, less than about 30.0 N, less than about 25.0 N, less than about 20.0 N, less than about 10.0 N, or less than about 5.0 N. For example, the removal force can be: about 1.0 N to about 60.0 N, about 5.0 N to about 50.0 N, about 5.0 N to about 45.0 N, about 5.0 N to about 40.0 N, about 5.0 N to about 35.0 N, about 5.0 N to about 30.0 N, about 5.0 N to about 25.0 N, about 5.0 N to about 20.0 N, about 5.0 N to about 15.0 N, or about 5.0 N to about 10.0 N.

[0409] In one example, the first finger 1025 is the thumb, and the second finger 1035 is the index finger, although the patient may use different fingers. The exposed surface 7032 of the lever 7030 can provide the patient with support or a point of contact or surface that the patient can press when the latch 3800-1 is detached from the retainer 3700-1. Figure 7M As shown, the patient can apply force to the latch 3800-1 with the first finger 1025 in a direction away from the retainer 3700-1 while pressing the second finger 1035 onto the lever 7030. Alternatively, as Figure 7N As shown, the patient can press the first finger 1025 onto the lever 7030 while applying force to the buckle 3800-1 with the second finger 1035 in a direction away from the retainer 3700-1.

[0410] exist Figure 7M In the illustrated example, the force applied to the latch 3800-1 can be applied by the first finger 1025 in the first hand position 1005A to a lateral or proximal region of the latch 3800-1, which is located in the region adjacent to the proximal surface 7500A of the latch 3800-1. If the latch 3800-1 includes a lip 7580, the first finger 1025 can engage and pull the lip 7580 upward. Figure 7N In the illustrated example, the force can be applied by the second finger 1035 in the first hand position 1005B to the side region, which is located in the area adjacent to the crossbar 7504 of the latch 3800-1. However, it should be understood that in either version of the first hand positions 1005A or 1005B, the force can be applied to other parts of the latch 3800-1, such as the crossbar 7504, another segment of the side region, or the proximal surface 7500A. Accordingly, the first finger 1025 or the second finger 1035 can apply force to the proximal surface 7500A (e.g., the lip 7580 (if included)), the crossbar 7504, or the side region to pry open the latch 3800-1 from the convex engagement structure provided as the first engagement structure 7010 of the retainer 3700-1.

[0411] Alternatively, the patient may prefer to partially disengage the snap 3800-1 from the retainer 3700-1 and change it as follows: Figure 7O The second hand position 1060 is shown. More specifically, the patient may prefer to use the fingers used to press the lever 7030 to obtain leverage to grasp another part of the buckle 3800-1 (e.g., the lip 7580, if included) and remove the buckle 3800-1 from the retainer 3700-1. Figure 7P An example depicting the result of this action is shown, in which the headgear connector 3600-1 is in a disengaged state.

[0412] Thanks to the leverage provided by the lever 7030, the patient does not need to apply such force to the crossbar 7504 as to make it feel strenuous or difficult for the patient to disengage and re-engage the buckle 3800-1 from the retainer 3700-1. Instead, the patient can use two fingers to perform the simple movement described above to disengage the buckle from the retainer, releasing the force applied by the headgear straps (see example...). Figure 6E and Figure 6H The tension of the lower strap 3304-1 is applied to remove the patient interface (such as patient interface 3000-3) from the patient. Although two exemplary hand positions for removing patient interface 3000-3 are shown, the patient can use any suitable finger or movement to disengage the clip 3800-1 from the retainer 3700-1.

[0413] Figures 7A to 7P The opening 7530 is depicted extending through the entire thickness of the snap fastener 3800-1, making it visible on the opposing surface of the snap fastener 3800-1. Furthermore, the engagement and disengagement of the snap fastener 3800-1 and the retainer 3700-1 have been discussed above from the perspective of the exposed surface 7032 of the rod 7030 protruding through the opening 7530 of the snap fastener 3800-1. Nevertheless, it is conceivable that in some forms of the technology described herein, the opening 7530 may not extend completely through the snap fastener 3800-1, such that when the snap fastener 3800-1 and the retainer 3700-1 are engaged, the rod 7030 is not visible and the surface 7032 can be positioned within the snap fastener 3800-1.

[0414] As described above regarding the ridge 7024 of the insert 7020 and the protruding edge of the receiver conversion portion 7528, various substructures can be provided in alternative forms, providing convex and concave engagement structures responsible for engaging the corresponding substructures. Furthermore, any first engagement structure of any retainer in the exemplary retainers described herein may include a concave engagement structure. Thus, any second engagement structure of any snap-fit ​​in the exemplary snap-fits described herein may include a convex engagement structure. Therefore, in Figures 7A to 7P In the case of the exemplary headgear connector 3600-1, one type of receiver 7520 can be incorporated into the retainer 3700-1, and one type of convex engagement structure can be incorporated into the snap 3800-1. Examples of such alternative versions of the headgear connector 3600-1 are described below.

[0415] More specifically, the retainer 3700-1 may include a rod 7030 and a receptacle 7520 extending from the base surface 7008A. Alternatively, an opening 7530 defined by the second body 7500 of the latch 3800-1 may be surrounded by an extension wall 7012 and a post 7020 extending from the second body 7500. In one example, engagement between retainer 3700-1 and latch 3800-1 may include: (1) aligning opening 7530 with rod 7030; (2) moving latch 3800-1 toward retainer 3700-1; (3) insert 7020 incorporated in latch 3800-1 engaging a first surface 7522, a receiver transition portion 7528 and a second surface 7524 of a receiver 7520 incorporated in retainer 3700-1; (4) rod 7030 extending through the area surrounded by insert 7020 of latch 3800-1 (and extension wall 7012 (if included)); and (5) a portion of insert 7020 extending through opening 7530.

[0416] Figure 7Q One form of headgear connector 3650-1 according to the present technology is shown (see example). Figures 7R to 7T The retainer 3750-1 is shown in a side perspective view. The retainer 3750-1 includes a first inclined surface defined by: (1) an extension wall 7012-1 of the insert 7020-1 and a riser 7022-1, or (2) only the riser 7022-1, wherein these risers extend to the base surface 7008A-1 (hereinafter referred to as "first inclined surfaces 7012-1, 7022-1"). As described below, the first inclined surfaces 7012-1, 7022-1 help the patient properly attach the snap 3800-1 to the retainer 3750-1 and prevent improper attachment.

[0417] As shown in the figure, the retainer 3750-1 includes a base wall 7008-1, a first engagement structure 7010-1, and a rod 7030 extending from a base surface 7008A-1 of the base wall 7008-1. The first engagement structure 7010-1 may include the base surface 7008A-1, an extension wall 7012-1 extending from the base surface 7008A-1, a plurality of posts 7020-1 extending from the extension wall 7012-1, and the rod 7030. Each post 7020-1 may include: a riser 7022-1 extending from the extension wall 7012-1; an outwardly projecting ridge 7024 on a side opposite to the rod 7030; and a second inclined surface 7026 extending from the ridge 7024. In some exemplary forms of the first joint structure 7010-1, the insert 7020-1 and more specifically the riser 7022-1 may extend from the base surface 7008A-1, such that there is no extension wall 7012-1 or the extension wall 7012-1 is longer than... Figure 7QThe extended wall shown is shorter.

[0418] As described above, the extension wall 7012-1 and riser 7022-1, or only riser 7022-1 (where these risers extend from the base surface 7008A-1), can define the first inclined surfaces 7012-1, 7022-1. In practice, the dimensions of the first inclined surfaces 7012-1, 7022-1 can be designed to have a height and an inclination angle to form a structure that prevents snap-fitting (such as...) Figures 7R to 7T The buckle 3800-1 depicted is inverted (i.e., as shown in the image). Figure 7R As shown, the connecting wall 7506 (facing away from the retainer 3750-1) is fixed to the retainer 3750-1. This type of mis-attachment prevention feature may be considered by some as a "foolproof" or "error-proof" feature. Such features can suppress mis-attachment of the snap fastener 3800-1, which could otherwise lead to one or more of the following potential problems: unstable connection to the patient interface; improper fit; discomfort; patient interface leakage; or difficulty in releasing the snap fastener 3800-1.

[0419] Figures 7R to 7T The various parts of the headgear connector 3650-1 in multiple engagement states are shown. The headgear connector includes a snap-fit ​​3800-1 and... Figure 7Q Holder 3750-1. Figure 7R An example of the disengaged state of the headgear connector 3650-1 is shown, wherein the latch 3800-1 may be in an exemplary position, in preparation for engagement, relative to the retainer 3750-1. More specifically, the latch 3800-1 and the retainer 3750-1 may be aligned such that a second engagement structure of the latch 3800-1 (which may include a first surface 7522, a second surface 7526, and a receiver transition portion 7528) is positioned to engage the first engagement structure 7010-1 when the latch 3800-1 moves toward the retainer 3750-1.

[0420] Go to Figure 7S The initial engagement between the receiver conversion section 7528 and the ridge 7024 is depicted. (As shown) Figure 7S As indicated by the arrow, due to the contact between the receiver conversion part 7528 and the ridge 7024, and the continued movement of the latch 3800-1 towards... Figure 7T The illustrated position moves downward, and the insert 7020-1 is biased inward toward the rod 7030. More specifically, when the receiver conversion part 7528 moves past the most outwardly protruding portion of the ridge 7024, the receiver conversion part 7528 will engage with the base of the ridge 7024 of the insert 7020-1. When this occurs, the material bias of the insert 7020-1 can cause the insert 7020-1 to open outward (e.g., Figure 7T(As indicated by the arrow in the image), it returns to its original position. Therefore, the ridge 7024 of the insert 7020-1 can be securely positioned within the receiver 7520 above the receiver conversion section 7528, and as... Figure 7T As shown, the clip 3800-1 can be securely attached to the retainer 3750-1. (As indicated...) Figure 7T As shown, in the engaged state of the headgear connector 3650-1, the first surface 7522 of the latch 3800-1 can be in static contact with the first inclined surfaces 7012-1 and 7022-1.

[0421] On the other hand, if the positioning of the clip 3800-1 causes the connecting wall 7506 to face with... Figure 7R In the opposite direction (i.e., away from the receiver 3750-1), the configuration of the extension wall 7012-1 and the riser 7022-1 prevents the receiver conversion part 7528 of the latch 3800-1 from moving over the ridge 7024 of the insert 7020-1 of the retainer 3750-1. More specifically, when the connecting wall 7506 is facing upward, the first inclined surfaces 7012-1, 7022-1 will prevent the receiver conversion part 7528 from moving over the ridge 7024. In some forms, this may be due to contact between the second surface 7524 of the latch 3800-1 and the first inclined surfaces 7012-1, 7022-1 or the top surface of the first inclined surfaces 7012-1, 7022-1. This type of contact prevents the inverted latch 3800-1 from moving further downward past a point where the innermost protruding part of the receiver conversion part 7528 is just above or flush with the outermost protruding part of the ridge 7024 of the insert 7020-1, even if the insert 7020-1 is in a fully retracted state (e.g., in contact with the rod 7030).

[0422] Although this article describes Figures 7Q to 7T While the specific "foolproof" mechanism is unclear, it's conceivable that other "foolproof" features could be incorporated into the headgear connector to replace... Figures 7Q to 7T The described "foolproof" feature or its combination thereof. Furthermore, although "foolproof" is described in detail with reference to headgear connector 3650-1, the same or other "foolproof" features may be incorporated into, for example, headgear connectors 3600-1, 3600-2, 3600-3, 3600-4, 3600-5, 3600-6 to facilitate the correct orientation of the latch relative to the retainer.

[0423] Figures 7R to 7TDetails of the body 7000-1 of the retainer 3750-1 are also shown, which can be incorporated into any of the retainers described herein. The inner surface of the body 7000-1 can define a cavity 7040-1 in the form of a tapered opening, which transitions into a probe hole 7042-1 defined by the inner surface of the rod 7030. The surface defining the cavity 7040-1 can transition around a position corresponding to the extension wall 7012-1 or the riser 7022-1 to the cylindrical inner surface of the rod 7030 defining the probe hole 7042-1. This hollow configuration of the base wall 7008-1 and the rod 7030 prevents dents from forming on the outer surface of the inflatable chamber of the defining wall when repeatedly used to disengage various types of clips from various types of retainers of this technology using the rod 7030. In other respects, the cavity 7042-1 can be of different shapes, or it can be omitted.

[0424] 5.3.3.4.2 Leverage Mechanism

[0425] Figure 8 A transparent perspective view of a headgear connector 3600-2 in an engaged state, according to one form of the present technology, is shown. The headgear connector 3600-2 can be incorporated into exemplary patient interfaces described herein (such as patient interfaces 3000-1, 3000-3 (see example...)). Figure 6H , Figure 7A , Figure 9A As described in more detail below, the snap 3800-2 can be configured to engage and secure to the retainer 3700-2 according to an engagement type that can be mechanical and, in some respects, may be devoid of any magnetic components.

[0426] like Figure 8 As shown, the retainer 3700-2 includes a first engagement structure 8010, which may include inserts 8020 extending from the base surface 8008A of the base wall 8008. Each insert 8020 may include a riser 8022 extending from the base surface 8008A, and an outwardly projecting ridge 8024 disposed on the upper portion of the riser 8022 opposite to the base surface 8008A. Furthermore, by extending from the base surface 8008A, the insert 8020 may define a convex engagement structure.

[0427] The second body 8500 of the snap fastener 3800-2 may define a concave engagement structure between the crossbar 8504 and the proximal surface 8500A, and provide a second engagement structure. This second engagement structure may be configured to engage and snap onto the ridge 8024 of the insert 8020. For example, the second engagement structure may include an opening that fully (e.g., through-hole) or partially extends through (e.g., blind-hole) the second body 8500 of the snap fastener 3800-2. The size of this opening may be designed to engage around the insert 8020. In some aspects, the opening may include an inwardly projecting ridge or lip configured to engage the riser 8022 of the insert 8020 below the projecting ridge 8024 of the insert 8020. This may facilitate engagement of the snap fastener 3800-2 with the retainer 3700-2. Accordingly, by being configured to receive the insert 8020 and securing the snap 3800-2 to the retainer 3700-2 through engagement with the ridge 8024, the snap can define a concave engagement structure.

[0428] In some forms of this technology, the convex engagement structure coupled with the first engagement structure 8010 may include four equally spaced inserts 8020. However, those skilled in the art will understand that different numbers of inserts 8020 in different arrangements can be provided. For example, two, three, four, five, six or more inserts 8020 may be provided. The implemented arrangement may correspond to the arrangement of a concave engagement structure that defines a second engagement structure incorporated into the snap-fit ​​3800-2.

[0429] Furthermore, similar to the exemplary headgear connector 3600-1, the exemplary headgear connector 3600-2 may include a frame 7004. This frame may provide an interface engagement structure for securing the headgear connector 3600-2 to connection points 3356, 3356-3 of patient interfaces (such as patient interfaces 3000-1, 3000-3). In other respects, the headgear connector 3600-2 may have similar functionality and may have features similar to those described above with respect to the headgear connector 3600-1.

[0430] 5.3.3.4.3 Rod and Stopping Slider Mechanism

[0431] Figure 9A A patient interface 3000-3, comprising a headgear connector 3600-3, is shown in one form according to the present technology. Figure 9B , Figure 9C and Figure 9D Top perspective view, bottom perspective view and side perspective view of retainer 3700-3 of one form of headgear connector 3600-3 according to the present technology are shown respectively. Figure 9E , Figure 9F and Figure 9G Top, bottom, and side perspective views of the latch 3800-3 of one form of the headgear connector 3600-3 according to the present technology are shown respectively. As described in more detail below, the latch 3800-3 can be configured to engage and secure to the retainer 3700-3 according to an engagement type, which can be mechanical and may in some respects be devoid of any magnetic components. Therefore, the retainer 3700-3 may not include a magnet and can be configured to be releasably engaged by the latch 3800-3 of the headgear connector 3600-3. The latch 3800-3 can be configured to engage the retainer 3700-3 and thus secure it to a patient interface, such as... Figure 9A The patient interface 3000-3 is shown. The retainer 3700-3 and the snap fastener 3800-3 can also be configured to be engaged and disengaged by a user, for example, with one hand. As described above with respect to the headgear connector 3600-1, the headgear connector 3600-3 can be located at the connection point 3356-3 (e.g., flange 3550) of the patient interface 3000-3.

[0432] like Figure 9B As shown, the retainer 3700-3 includes a tab surface 9002 extending distally from a first proximal end portion 9000A of the retainer 3700-3. A first engagement structure 9010 extends from a first base surface 9008A of a first base wall 9008 and is spaced apart from the distal region 9000B of the retainer 3700-3. The first engagement structure 9010 includes a rod 9012 extending upward from the first base surface 9008A and a stop 9514 disposed at an end of the rod 9012 opposite to the end extending from the first base surface 9008A. The width of the stop 9514 may be greater than the width of the rod 9012. The stop 9514 may be, for example, disc-shaped or spherical, and may have an edge having a chamfer, bevel, rounded corner, or forming a right angle with the exposed surface 9016.

[0433] like Figure 9C and Figure 9D As shown, similar to the exemplary headgear connectors 3600-1 and 3600-2, the exemplary retainer 3700-3 for the headgear connector 3600-3 includes a frame 7004. The frame 7004 may provide an interface engagement structure that can be used to secure the headgear connector 3600-3 to a connection point (as described with reference to headgear connector 3600-1) of a patient interface (such as patient interface 3000-1, 3000-3), such as connection point 3356, 3356-3.

[0434] In addition to the outer surface of the main body of the stop 9014, the exposed surface 9016 of the stop 9014 can also be configured to engage part of the latch 3800. In some forms of this art, the outer surface of the stop can be configured to engage the surface of the second receiver 9550, as described below. Figure 9H , Figure 9I , Figure 9K The above discussion. Furthermore, in some forms of this technology, the exposed surface 9016 can be configured to contact the second basal surface 9508A during the bonding process (see, for example...). Figure 9F and Figure 9I Alternatively, it may rest against or be adjacent to the second base surface. In various forms of this technology, when the first engagement structure 9010 engages with the second engagement structure 9510 of the snap-fit ​​3800-3, the exposed surface 9016 may be configured to contact or be adjacent to the second base surface 9508A, as described below. Figures 9E to 9K The explanation.

[0435] Figure 9E , Figure 9F and Figure 9G Figure H shows a top perspective view, a bottom perspective view, and a side perspective view of the snap 3800-3 of one form of headgear connector 3600-3 according to the present technology. Figure 9F A partial perspective magnified view of a portion of the headgear connector. (See image.) Figure 9E As shown, the snap fastener 3800-3 may include a crossbar 9504, one or more slots, or another suitable mechanism through which a strap (such as a lower strap 3304-1) may pass over or through to secure the snap fastener 3800-3 to such a mechanism. Figure 9F As shown, the snap fastener 3800-3 also includes a second base wall, which is partially defined by a second base surface 9508A and serves as a second edge 9508B.

[0436] like Figure 9F and Figure 9H As shown, the second engagement structure 9510 may include: (1) a first receiver 9520 spaced apart from the second base surface 9508A; and (2) a second receiver 9550 (see example...). Figure 9H , Figure 9I and Figure 9J The second receiver extends between the second base surface 9508A and the first receiver 9520. In one example, the combination of the second base surface 9508A with the first receiver 9520 and the second receiver 9550 defines a slot 9560 (see example...). Figure 9IThis defines a concave engagement structure that can be configured to accommodate a stop 9514 of the convex engagement structure of the retainer 3700-3 between the first receiver 9520 and the second base surface 9508A, as described below. Figures 9A to 9C as well as Figures 9L to 9O A more detailed explanation.

[0437] Continue to refer to Figure 9F and Figure 9H The first receiver 9520 extends from the proximal surface 9500A of the body 9500 of the snap fastener 3800-3 to its first end face 9524. Furthermore, the first receiver 9520 includes a first connecting wall 9522, a partition 9526, and a receiver transition portion 9528 incorporated in the partition 9526. The first connecting wall 9522 is formed between the proximal surface 9500A and the partition 9526, and includes: (1) a first edge 9523 extending from the proximal surface 9500A; and (2) a wing side 9525 extending outward and distally from the opposite side of the first edge 9523.

[0438] like Figure 9H As shown, each wing 9525 extends between the side surface 9500B of the latch 3800-3 and the first surface 9520A of the first receiver 9520, and is spaced apart from a corresponding leg 9529 of the partition 9526. The surfaces of the legs 9529 face each other and define the first surface 9520A of the first receiver 9520. The legs 9529 extend from a head 9527 of the partition 9526, which may correspond to a first edge 9523 and a channel 9530 defined by the first surface 9520A, and the first edge and the channel are located on the wing side of the head. The inner surfaces of the head 9527 and the legs 9529 respectively provide the proximal and distal portions of the second surface 9520B of the first receiver 9520.

[0439] Partition 9526 may be a continuous structure including a receiver transition portion 9528 located between each leg 9529 (and a corresponding distal portion of the second surface 9520B) and a corresponding end of a head 9527 extending therefrom of the leg 9529 (and a corresponding proximal portion of the second surface 9520B). In some exemplary forms of the present technology, each receiver transition portion 9528 may be formed as a protruding edge extending into the region between a first receiving space defined by the leg 9529 and a second receiving space 9540 defined by the head 9527. The receiver transition portions 9528 are commonly disposed on opposite sides of the neck region 9528A. In one example, the distance between the receiver transition portions 9528 in a direction perpendicular to the longitudinal axis of the latch 3800-3 defines the width of the neck region 9528A, which may be less than the diameter of the rod 9012 of the first engagement structure 9010 of the retainer 3700-3.

[0440] For reference Figures 9L to 9O In more detail, the engagement between the retainer 3700-3 and the snap fastener 3800-3 may include: (1) movement of the second engagement structure 9510 (concave engagement structure) relative to the rod 9012 of the first engagement structure 9010 (convex engagement structure); (2) this relative movement causing the receiver conversion portion 9528 to engage the rod 9012 of the first engagement structure 9010; (3) the rod 9012 pushing or otherwise causing the receiver conversion portion 9528 (and thus pushing or otherwise) (3) The legs 9529) are deflected away from each other (assuming that the force causing this relative movement is sufficient to overcome the material bias exhibited by partition 9526 at the receiver conversion section 9528); and (4) the head 9527 surrounds the rod 9012 and thus secures the snap 3800-3 to the retainer 3700-3, wherein the stop 9514 of the convex engagement structure of the retainer 3700-3 is positioned in the slot 9560 between the first receiver 9520 and the second base surface 9508A.

[0441] Figure 9I It shows from and Figure 9E The plane corresponding to line 9I-9I in the middle faces as follows Figure 9E A cross-sectional view of the buckle 3800-3 as observed from direction I. (See diagram below.) Figure 9I As shown, the slot 9560 includes a space defined between the first receiver 9520 and the second base wall 9508. Furthermore, as... Figure 9I As shown, the slot 9560 is defined by the surface of a second receiver 9550, which may include a guide wall 9552 and a sidewall 9553, the sidewall extending from the guide wall 9552 and terminating at a second end face 9554 (see example). Figure 9JIn the illustrated example, the sidewall 9553 may converge in the direction of movement from the second end face 9554 toward the guide wall 9552. In some forms, the sidewall 9553 may act as a guide for the second engagement structure 9510 as the latch 3800-3 moves distally relative to the first engagement structure 9010. More specifically, during this movement, the reaction force generated by the contact between the sidewall 9553 and the stop 9514 may cause the latch 3800-3 to move relative to each other, such that the rod 9012 may be substantially centered between the wings 9525 and around the head 9527 of the partition 9526.

[0442] Figure 9J It shows from and Figure 9F The plane corresponding to line 9J-9J in the middle faces as follows Figure 9F A cross-sectional view of the buckle observed in the indicated direction J. (See diagram below.) Figure 9J As shown, portions of the surface of the guide wall 9552 may include a stop contact surface 9552A and a partition contact surface 9552B. The stop contact surface 9552A may correspond to a portion of the guide wall 9552 extending from the second base surface 9508A to a point or level corresponding to the top edge 9521 of the head 9527 of the partition 9526. Conversely, the partition contact surface 9552B may extend from this point or level to a second edge 9535. As shown, the second edge 9535 may define a transition portion (e.g., a stepped wall or surface) located between the second receiver 9550 and the proximal portion of the first surface 9520A of the receiver 9520, at least within the region of the guide wall 9552.

[0443] In some forms of this technology, the second edge 9535 may also define a channel 9530, which is typically defined by the first surface 9520A between the partition 9526 and the first connecting wall 9522. Figure 9F , Figure 9H The guide section 9531 of the channel 9530 can be defined as a section of the channel 9530 that is closed by the second edge 9535 or otherwise defined due to the adjacency between the partition 9526 and the second receiver 9550. More specifically, the guide section 9531 corresponds to the area where the distal portion of the first surface 9520A of the head 9527 contacts the partition contact surface 9552B. Therefore, the guide section 9531 can be defined by the second edge 9535, and thus provides a closed section of the channel 9530. Including the channel 9530 allows the partition 9526 to move and deflect slightly relative to the first connecting wall 9522, which can reduce assembly and disassembly forces.

[0444] As described above, at least in a portion of the head 9527, the partition contact surface 9552B may face and be adjacent to the distal portion of the first surface 9520A. (See reference...) Figure 9K To explain in further detail, the contact between the distal portion of the first surface 9520A and the partition contact surface 9552B can provide a stop device that prevents linear movement of the partition 9526 when the rod 9012 of the convex engagement structure is engaged by the receiver conversion portion 9528 of the concave engagement structure.

[0445] Figure 9K It shows from and Figure 9G The plane corresponding to line 9K-9K in the middle faces as follows Figure 9G The cross-sectional view of the buckle 3800-3 observed in the indicated direction K. (See diagram below.) Figure 9K As shown, the top edge 9521 of partition 9526 may abut against guide wall 9552, thus obstructing the view of passage 9530 in that area, or a space may exist between the top edge 9521 of partition 9526 and guide wall 9552. A side section 9533 of passage 9530, located in the area between the leg 9529 of partition 9526 and the wing side 9525 of first connecting wall 9522, may define an open passage 9530. Furthermore, the side section 9533 of passage 9530 defines a gap in which, at least when receiver conversion 9528 engages rod 9012, the leg 9529 and receiver conversion 9528 can elastically deform (e.g., unfold or separate) as latch 3800-3 slides along retainer 3700-3 in a direction from the first proximal end 9000A toward the first engagement structure 9010 and distal region 9000B. As mentioned above, the movement of partition 9526 toward the second container 9550 is due to the factors described above and... Figure 9F and Figure 9J Contact inhibition between the areas corresponding to the guide section 9531 of channel 9530 marked in the middle.

[0446] Figures 9L to 9O A headgear connector 3600-3 in multiple engagement states, according to the present technology, is shown. More specifically, Figure 9L The disengaged state of the headgear connector 3600-3 is illustrated, with the latch 3800-3 positioned above the retainer 3700-3. In one example, Figure 9L The snap fastener 3800-3 is illustrated in an exemplary position relative to the retainer 3700-3, such that the second engagement structure 9510 is prepared to engage with the first engagement structure 9010. In one example, this may include a stop 9514 generally spatially aligned with the area between the crossbar 9504 of the snap fastener 3800-3 and the first end face 9524 and the second end face 9554.

[0447] Figure 9L One aspect of the usability level provided by the exemplary headgear connector 3600-3 is illustrated. More specifically, when attempting to attach the snap 3800-3 to the retainer 3700-3, the patient can use the same hand to hold the snap 3800-3 and position the retainer 3700-3. That is, the patient can use a finger that does not touch the snap 3800-3 to search for and position the stop 9514 of the retainer 3700-3 without much effort. Furthermore, the patient can use the stop 9514 to guide the movement of the snap 3800-3 generally toward the retainer 3700-3, and specifically to engage with the retainer.

[0448] The patient's ability to perform the aforementioned actions using one hand can be attributed to the easily identifiable shape and elevated position of the stop 9514 relative to the remainder of the retainer 3700-3. Furthermore, the exposed surface 9016 of the stop 9514 can be formed by one or more structural elements (such as recesses, bumps, grooves, notches, serrations, ridges, knurling, and textures) to enhance the tactile distinctiveness of the stop 9514. Such structural features can also be incorporated into the body of the stop 9514 on a surface extending perpendicular to the exposed surface 9016, or additionally or alternatively incorporated into other portions of the retainer 3700-3, such as the tab surface 9002 (e.g., Figure 9B (As shown by the protrusion). Accordingly, some patients who may have difficulty grasping objects due to dexterity issues may be able to attach the buckle 3800-3 to the retainer 3700-3 with one hand, to a degree that can accommodate such patients. As described above regarding the headgear connector 3600-3, although one-handed use is described, two-handed use is also conceivable.

[0449] With this general alignment, the latch 3800-3 can move toward the retainer 3700-3 and engage with... Figure 9M The position corresponding to the first partial engagement state is shown. In one example, the exposed surface 9016 of the stop 9514 may contact a portion of the second base surface 9508A (see example...). Figure 9H In use, the latch 3800-3 can be positioned such that the central region of the area surrounded by the head 9527 is substantially aligned with the central longitudinal axis of the rod 9012. This alignment allows the receiver conversion section 9528 (see example) Figure 9F and Figure 9H The engagement rod 9012 is engaged without prior contact between the rod 9012 and one of the legs 9529 of the partition 9526. However, as discussed above, the converging configuration of the legs 9529 ensures that the receiver conversion section 9528 moves into initial engagement with the rod 9012, as... Figure 9NAs shown, the latch 3800-3 moves in a direction away from the first proximal end 9000A of the retainer 3700-3.

[0450] Figure 9N The second part of the headgear connector 3600-3 is shown in engagement. As mentioned above, in Figure 9N At the illustrated location, the receiver transition portion 9528 of the first receiver 9520 can engage with the surface of the rod 9012. In one example, this second engagement state can correspond to a point during the engagement process just before or at which the receiver transition portions 9528 begin to deflect away from each other. (Refer to the above text.) Figure 9J and Figure 9I The side section 9533 of the channel 9530 provides a slot area that can accommodate the outward movement of the receiver conversion section 9528 and the leg 9529.

[0451] In some forms of this technology, the retainer 3700-3 and the snap fastener 3800-3 may be formed of different materials. In one example, the snap fastener 3800-3 may be formed of a plastic (e.g., a thermoplastic polymer material, such as polycarbonate). The retainer 3700-3 may be formed of a plastic (e.g., a thermoplastic polyester elastomer material, the stiffness of which may be less than the stiffness of the snap fastener 3800-3). As described above with reference to retainer 3700-1 and snap fastener 3800-1, retainer 3700-3 and snap fastener 3800-3 may be formed of the same or different materials, and / or parts of retainer 3700-3 and snap fastener 3800-3 may be formed of the same or different materials.

[0452] As will be appreciated by a person skilled in the art, the outward deflection of the receiver conversion section 9528 and the leg 9529 can continue as the latch 3800-3 moves away from the proximal end 9000A of the retainer 3700-3, at least until the midpoint of the receiver conversion section 9528 advances past the central longitudinal axis of the rod 9012. However, after passing this axis, the material bias of the partition 9526 can provide a spring-like effect, causing the leg 9529 and the receiver conversion section 9528 to move (retract) or be biased toward each other to their original positions. Furthermore, the head 9527 can engage the surface of the rod 9012 with the proximal portion of the second surface 9520B of the first receiver 9520, as shown in 9O.

[0453] Figure 9O The engagement state of the headgear connector 3600-3 is illustrated. As shown, the stop 9514 can contact the second receiver 9550, and the rod 9012 can contact the second surface 9520B of the first receiver 9520.

[0454] Figures 9M to 9OAdditional exemplary aspects of the availability that can be provided by the exemplary headgear connector 3600-3 are also demonstrated. Specifically, engagement between the first engagement structure 9010 and the second engagement structure 9510 can be achieved by moving the snap 3800-3 away from the proximal end 9000A of the retainer 3700-3. Furthermore, the corresponding exemplary circular and cylindrical configurations of the head 9527 and the rod 9012 allow for some deviation in the perfect alignment of the longitudinal axis of the retainer 3700-3 and the longitudinal axis of the snap 3800-3 without hindering the patient's advancement from either the first or second part-engaged state to ultimately enter the device. Figure 9O The ability to form the indicated engagement state.

[0455] Those skilled in the art will recognize that other shapes can serve as the basis for the design of the engagement components of the head connector 3600-3. This flexibility can be achieved in part through the converging configuration of the legs 9529. The legs 9529 of the first receiver 9520 can guide the snap-fit ​​3800-3 to abut against and move relative to the rod 9012 and the stop 9014. The legs 9529 can guide the movement of the snap-fit ​​3800-3 by acting as a funnel and guiding the rod 9012 and the stop 9014 as they are received within the snap-fit ​​3800-3, thereby moving the rod 9012 and the stop 9014 toward the receiver transition section 9528 and the head 9527.

[0456] Regarding further availability, feedback can be used to indicate engagement of the latch 3800-3 to the retainer 3700-3. This feedback sends a signal to the patient notifying them of either engagement or disengagement of the latch 3800-3 and retainer 3700-3, or indicating either situation. For example, when removing the latch 3800-3 from... Figure 9N The second part of the engagement state shown moves to Figure 9O In the exemplary engaged state, the lever 9012 can be engaged in the head 9527. This can generate one or both of auditory and tactile feedback to the patient. On the one hand, engaging the head 9527 in the position surrounding the lever 9012 can produce a clicking sound, which can serve as notification that engagement has been completed. In terms of tactile feedback, the patient can feel overcoming the resistance exerted on the lever 9012 by the receiver transition portion 9528. Additionally or alternatively, the patient can feel the impact of the lever 9012 and / or the stop 9014 on the second surface 9520B of the first receiver 9520 and / or the stop contact surface of the second receiver 9550, or the vibration caused therefrom. Disengagement of the latch 3800-3 from the retainer 3700-3 can similarly provide one or both of auditory and tactile feedback.

[0457] In cases where there is no perfect longitudinal alignment between the retainer 3700-3 and the latch 3800-3, the exemplary configuration of the head 9527 and the rod 9012 can help facilitate engagement. This configuration also allows the latch 3800-3 to rotate around the rod 9012 and relative to the retainer 3700-3 when the patient wears the patient interface 3000-3, for example, during movement while awake and / or asleep. If the relative rotation of the head connector 3600-3 is not accommodated, some movement by the patient that could lead to such rotation would result in a certain amount of tension or other force being applied to the patient by one or more components of the patient interface. Furthermore, without the limited rotation allowed between the latch 3800-3 and the retainer 3700-3 according to the present technology, the patient may experience varying degrees of discomfort. In some respects, if the snap fastener 3800-3 and retainer 3700-3 are not allowed to rotate relative to each other, the force applied during movement may cause the snap fastener 3800-3 and retainer 3700-3 to disengage, resulting in accidental loosening or detachment of the patient interface, which could potentially interrupt the delivery of the intended treatment. Therefore, such movement may not be noticed by the patient or generally not be considered a nuisance, and / or may reduce the occurrence of accidental loosening or detachment of the patient interface. Furthermore, the incorporation of channel 9530 allows partition 9526 to move freely and deflect slightly, which also allows the snap fastener 3800-3 and retainer 3700-3 to move relative to each other without disengaging.

[0458] 5.3.3.4.4 Open Recipient Rod-Slider Mechanism

[0459] Figure 10A A headgear connector 3600-4, according to one form of attachment to a patient interface 3000-4, is shown. The headgear connector 3600-4 may include a retainer 3700-4 and a snap fastener 3800-4. The snap fastener 3800-4 may be detachably connected to a slider 10570 through which headgear straps (such as lower straps 3304-1, 3304-2) may pass. The slider 10570 may alternatively be one or more of a crossbar, one or more slots, or another suitable mechanism through which straps may bypass or pass and be secured to the snap fastener 3800-4. As described in more detail below, the concave or convex engagement structure of the second engagement structure 10510 of the snap fastener 3800-4 may be positioned relative to the convex or concave engagement structure of the first engagement structure 10010 of the retainer 3700-4, and the snap fastener 3800-4 may be positioned along the engagement direction E( Figure 10E Move until the headgear connector 3600-4 is engaged, such as... Figure 10A and Figure 10GThe exemplary engagement state is depicted. As described in more detail below, the snap 3800-4 can be configured to engage and secure to the retainer 3700-4 according to an engagement type that can be mechanical and, in some respects, may be devoid of any magnetic components.

[0460] Figure 10A and Figure 10B A first engagement structure 10010 of a retainer 3700-4 according to the present technology is shown. In one example, the first engagement structure 10010 may include a base surface 10008A and a convex engagement structure 10020 extending from the base surface 10008A. Furthermore, the convex engagement structure 10020 may include: a rod 10022 extending from the base surface 10008A; an exposed surface 10026 disposed at an end of the convex engagement structure 10020 opposite to the end extending from the base surface 10008A; and a ridge 10024 projecting outwardly from a surface between the rod 10022 and the exposed surface 10026 of the convex engagement structure 10020. Figure 10A and Figure 10B In the exemplary form illustrated, the exposed surface 10026 may have a curved dome-shaped profile, a flat surface, or a concave or convex surface.

[0461] In some forms of this technology, the base surface 10008A may be formed as part of or attached to a component, flange, or frame located on or fixed to the inflatable chamber of the patient interface 3000-4, as described above with reference to the headgear connector 3600-1. In some aspects, the convex engagement structure 10020 may be formed as an integral component having the base surface 10008A, thereby providing... Figures 10A to 10C The exemplary headgear connector 3600-4 illustrates a connection point 3356-4. In other forms, the convex engagement structure 10020 may be a separate component attached to the base surface 10008A.

[0462] Figure 10C A form of snap fastener 3800-4 according to the present technology is shown. Snap fastener 3800-4 includes a second body 10500 having a side surface 10500B and a proximal surface 10500A. In one form, the proximal surface 10500A extends from the second proximal end of snap fastener 3800-4 and transitions to... Figure 10C The side surface 10500B is shown. The second joining structure 10510 may include a base 10512 and a receiver 10520, the receiver including a first connecting wall 10522 and a partition 10526.

[0463] like Figure 10CAs shown, the first connecting wall 10522 may include a flange 10523 and a wing 10525. In some forms, the flange 10523 extends from the proximal surface 10500A of the snap fastener 3800-4 to a first surface 10520A of the receiver 10520. The first surface 10520A defines a channel 10530 disposed between the first connecting wall 10522 and the partition 10526. The inclusion of the channel 10530 allows the partition 10526 to move and deflect slightly relative to the first connecting wall 10522, which can reduce assembly and disassembly forces. The wing 10525 may extend from the opposite side of the flange 10523 and the side surface 10500B of the snap fastener 3800-4 to a second connecting wall 10550 of the receiver 10520. Figure 10C As shown, the proximal portion of each wing side 10525 extends between the corresponding side surface 10500B and the first surface 10520A of the latch 3800-4, and is disposed outside the corresponding leg 10529 of the partition 10526.

[0464] like Figure 10C As shown, partition 10526 includes a head 10527 and the aforementioned leg 10529, which extends from the head 10527. The head 10527 may correspond to and be surrounded by an edge 10523 and a channel 10530 defined by a first surface 10520A. Partition 10526 may be a continuous structure including a receiver transition portion 10528 formed between the corresponding ends of each leg 10529 and the head 10527. The receiver transition portions 10528 collectively define a neck region 10528A and may correspond to the boundary between the first receiving space 10540 and the second receiving space 10542 of the receiver 10520. In one embodiment, the first receiving space 10540 may be defined by a region within the latch defined by a distal portion of the second surface 10520B of the receiver 10520, the distal portion being defined by the leg 10529 and the second connecting wall 10550. The second receiving space 10542 may be defined by a region surrounded by a proximal portion of the second surface 10520B of the receiver 10520, the proximal portion being defined by the head 10527.

[0465] In one example, the distance between the receiver transition portions 10528 in a direction perpendicular to the longitudinal axis of the snap 3800-4 defines the width of the neck region 10528A, which is smaller than the diameter of the rod 10022 of the first engagement structure 10010 on the retainer 3700-4. (See reference...) Figures 10D to 10GIn a more detailed description, the engagement between the retainer 3700-4 and the latch 3800-4 may include: (1) aligning the first receiving space 10540 with the exposed surface 10026 of the first engagement structure 10010 and moving the latch 3800-4 toward the retainer 3700-4 such that the leg 10529 and the second connecting wall receive the rod 10022; (2) moving the latch (towards the distal end) such that the receiver conversion portion 10528 engages the rod 10022 of the first engagement structure 10010; (3) the rod 10022 pushes or otherwise deflects the receiver conversion portions 10528 away from each other outward (assuming that the force causing the movement is sufficient to overcome the material bias exhibited by the partition 10526 at the receiver conversion portion 10528); and (4) the head 10527 receives the rod 10022 and thus secures the latch 3800-4 to the retainer 3700-4.

[0466] Figures 10D to 10G A headgear connector 3600-4 in multiple engagement states, according to the present technology, is shown. More specifically, Figure 10D The example illustrates the disengaged state of the headgear connector 3600-4, with the latch 3800-4 positioned above the retainer 3700-4. In one example, Figure 10D The example illustrates a snap-fit ​​3800-4 in an exemplary position relative to the retainer 3700-4, such that the second engagement structure 10510 is prepared to engage with the first engagement structure 10010. In one example, this may include a first receiving space 10540 substantially aligned with the exposed surface 10026 of the convex engagement structure. With this alignment, the snap-fit ​​3800-4 can move toward the retainer 3700-4 and engage with... Figure 10E The position corresponding to the first part of the engagement state shown.

[0467] As mentioned above, Figure 10E The headgear connector 3600-4 is shown in a first partially engaged state. The exposed surface 10026 of the convex engagement structure may extend above, flush with, or slightly recessed relative to, the surface of the snap-fit ​​3800-4, and the leg 10529 may engage with the rod 10022 (see...). Figure 10D Contact. In one example, rod 10022 may also contact the front edge of leg 10529 / receiver transition section 10528. From Figure 10E The position depicted, along the engagement direction E, allows the latch 3800-4 to move, thus enabling the rod 10022 to substantially engage with the receiver conversion part 10528, as shown. Figure 10F As shown.

[0468] Figure 10FThe second part of the engagement state of the headgear connector 3600-4 is shown. In one example, this second part of the engagement state may correspond to a point in the engagement process where the receiver transition sections 10528 deflect away from each other to allow the rod 10022 to move past the receiver transition section 10528. As shown, the channel 10530 includes a guide section 10531 extending around the head 10527 of the partition 10526, and a side section 10533 extending along the periphery of the leg 10529. The side section 10533 of the channel 10530 provides a gap area that accommodates the outward movement of the receiver transition section 10528.

[0469] Figure 10G The mating state of the headgear connector 3600-4 is illustrated. As shown, the rod 10022 can be received by the partition 10526, and the ridge 10024 overlaps with a portion of the partition surface 10526A. In one form of this technology, Figures 10D to 10G The illustrated steps can be performed in reverse order to disengage the snap 3800-4 from the retainer 3700-4.

[0470] Figure 10H A front view of a headgear connector 3600-4 in a partially disengaged state, according to one form of the present invention, is shown. The ridge 10024 of the first engagement structure 10010 can be dimensioned such that the patient can disengage the headgear connector 3600-4 when a force is applied to one of the side surfaces, such as the snap-fit ​​3800-4, away from the patient interface. According to one aspect of the present invention, the two methods for disengaging the headgear connector 3600-4 described above can be performed by the patient with one hand. However, those skilled in the art will understand that some patients may have concerns... Figure 10H The presented procedure may occur without the patient initiating it. Accordingly, some forms of this technology may include a ridge 10024 configured to largely overlap with the partition surface 10526A, and thus remove... Figure 10H The presented disengagement option. In this form of the technology, disengaging the latch 3800-4 from the retainer 3700-4 may involve sliding the rod 10022 across the receiver transition section 10528 and back into the first receiving space 10540, and then lifting the latch 3800-4 away from the retainer 3700-4.

[0471] Regarding further availability, feedback can be used to indicate engagement of the latch 3800-4 to the retainer 3700-4. This feedback sends a signal to the patient notifying them of either engagement or disengagement of the latch 3800-4 and retainer 3700-4, or indicating either situation. For example, when removing the latch 3800-4 from... Figure 10F The second part of the engagement state shown moves to Figure 10GIn the exemplary engaged state, the rod 10022 can be engaged into the second receiving space 10542. This can generate one or both of auditory and tactile feedback to the patient. On the one hand, engaging the second receiving space 10542 into a position around the rod 10022 can produce a clicking sound, which can serve as notification that engagement has been completed. In terms of tactile feedback, the patient can feel overcoming the resistance exerted on the rod 10022 by the receiving transition portion 10528. Additionally or alternatively, the patient can feel the impact of the rod 10022 on the head 10527 of the partition 10526, or the vibration caused thereby. Disengaging the latch 3800-4 from the retainer 3700-4 can similarly provide one or both of auditory and tactile feedback.

[0472] In cases where there is no perfect longitudinal alignment between the retainer 3700-4 and the latch 3800-4, the exemplary configuration of the head 10527 and the rod 10022 can help facilitate engagement. This configuration also allows the latch 3800-4 to rotate around the rod 10022 and relative to the retainer 3700-4 when the patient wears the patient interface 3000-4, for example, during movement while awake and / or asleep. If the relative rotation of the head connector 3600-4 is not accommodated, some movement by the patient that could lead to such rotation would result in a certain amount of tension or other force being applied to the patient by one or more components of the patient interface. Furthermore, without the limited rotation allowed between the latch 3800-4 and the retainer 3700-4 according to the present technology, the patient may experience varying degrees of discomfort. In some respects, if the snap fastener 3800-4 and retainer 3700-4 are not allowed to rotate relative to each other, the force applied during movement may cause the snap fastener 3800-4 and retainer 3700-4 to disengage, resulting in accidental loosening or detachment of the patient interface, which could potentially interrupt the delivery of the intended treatment. Therefore, such movement may not be noticed by the patient or generally not be considered inconvenient, and / or may reduce the occurrence of accidental loosening or detachment of the patient interface. Furthermore, the incorporation of channel 10530 allows the head 10527 to move freely and slightly deflect, which also allows the snap fastener 3800-4 and retainer 3700-4 to move relative to each other without disengaging.

[0473] 5.3.3.4.5 Protrusion Slider Mechanism

[0474] Figure 11A A patient interface 3000-4, comprising a headgear connector 3600-5, is shown according to one form of the present technology. As described in more detail below, the snap 3800-5 can be configured to engage and secure to the retainer 3700-5 according to an engagement type, which can be mechanical and, in some respects, may be devoid of any magnetic components. Figure 11AAs shown, the patient interface 3000-5 may include: an inflation chamber 3200-5; a positioning and stabilizing frame 3370-5 (e.g., detachably connected to the inflation chamber); a vent 3400-5 connected to the inflation chamber 3200-5; an upper strap 3305-5 attached to the positioning and stabilizing frame 3370-5; a headgear connector 3600-5; and a lower strap 3304-5 attached to the headgear connector 3600-5. In one form of the present technology, the positioning and stabilizing frame 3370-5 includes a frame body 3372-5 and a first arm 3374-5 (e.g., lower) and a second arm 3376-5 (e.g., upper) extending from each outer side of the frame body 3372-5. Figure 11A In the illustrated exemplary assembled state, the frame body 3372-5 surrounds the vent 3400-5, and a retainer 3700-5 for the headgear connector 3600-5 extends from a first arm 3374-5, which extends from the frame body 3372-5. The arm 3374-4 and the retainer 3700-5 may be integrally formed from the same material with the frame body 3372-5. The headgear connector 3600-5 may take the form of... Figures 7A to 7Z The form shown, for example, employs a non-magnetic connection, which includes a first engagement structure 7010 and a snap-fit ​​3800-1 with a through opening for receiving a rod (see, for example, see...). Figure 11D Each lower strap 3304-5 can wrap around the crossbar 11504 of the corresponding buckle 3800-5 (see, for example, see...). Figure 11B One or more slots or other suitable mechanisms, around which straps (such as lower straps 3304-5) may be wrapped or passed. Each upper strap 3305-5 may wrap around the end of a corresponding second arm 3376-5. The rear surface 3376-5S of the arm 3376-5 may include a recess to help reinforce the arm 3376-5 near a portion of the frame body 3372-5, for example, as shown in the image. Figure 11D As shown.

[0475] Go to Figure 11B The retainer 3700-5 includes a deflectable tab 11024 and a first base wall 11008 extending from the first arm 3374-5 and surrounding the periphery of the tab 11024. A biasing wall 11022 may extend between the first base wall 11008 and the tab 11024. The first base wall 11008 includes a first base surface 11008A and a first edge 11008B, which, in some forms of the art, may contact or otherwise engage corresponding surfaces of the latch 3800-5, as described in more detail below.

[0476] In one embodiment, the bias wall 11022 may extend obliquely from the first base wall 11008, such that in the unengaged state, the tab 11024 is biased upward and at a specific angle relative to the plane of the first base surface 11008A. This can position the tab 11024 such that the end of the tab 11024 adjacent to the first edge 11008B is positioned lower than the opposite end of the tab 11024, which can facilitate engagement. In other examples, the bias wall 11022 extends without obliqueness, and the tab 11024 may lie in a plane parallel to the first base surface 11008A. The tab 11024 may be configured to have a height greater than the height of the first base surface 11008A, such that the tab 11024 is configured to extend through and interlock with a portion of the receiver 11520 of the latch 3800-5 to prevent disengagement of the latch 3800-5 after engagement with the retainer 3700-5. Therefore, tab 11024 and offset wall 11022 define a convex engagement structure, which together with the first base wall 11008 defines the first engagement structure 11010 of retainer 3700-5.

[0477] The retainer 3700-5 may additionally include a first stop device 11014 positioned above or below and adjacent to the first base wall 11008, for example, such as Figure 11B As shown. The first stop device 11014 may include a curved profile corresponding to the curvature of the second edge 11508B defined by the proximal end of the second base wall 11508 of the snap fastener 3800-5, or may have a shape that does not correspond to the curvature of the second edge 11508B. In some forms, the first stop device 11014 may restrict movement of the snap fastener 3800-5 in the engagement direction E. In other forms, the stop device may be used to facilitate or guide controlled and restricted rotational movement of the snap fastener 3800-5 relative to the retainer 3700-5.

[0478] like Figure 11B As shown, the snap fastener 3800-5 includes a second base wall 11508, a side wall 11502 extending from, for example, a crossbar 11504 or other connecting member as described above (to overlap a portion of the second base wall 11508), and a receiver 11520 extending from a connecting wall 11512. The receiver 11520 defines a concave engagement structure of the snap fastener 3800-5. In some forms, a second stop 11514 is provided as a vertical wall extending from the second base wall 11508 to the connecting wall 11512 of the exemplary snap fastener 3800-5. Together with the connecting wall 11512 and the second stop 11514, the receiver 11520 provides a second engagement structure 11510 for the snap fastener 3800-5.

[0479] In use, from Figure 11BAs the illustrated disengaged state begins, the latch 3800-5 can move toward the retainer 3700-5. Once the portion of the engaging tab 11024 of the connecting wall defining the front edge of the receiver 11520 is engaged, the tab 11024 can be pressed or otherwise deflected downwards until it is substantially flush with the first base surface 11008A. As the latch 3800-5 continues to move along the engagement direction E, the surfaces of the second base wall 11508 and the receiver 11520 of the latch 3800-5 can contact and slide relative to the tab 11024 and the first base wall 11008. In particular, the second base surface 11508A of the second base wall 11508 can contact and slide relative to the bottom surface 11008C of the first base wall 11008. Continued movement can substantially align the center of the receiving space 11540 defined by the receiver 11520 and the second base wall 11508 with the center of the tab 11024, and the tab 11024 can be biased upward into the receiving space 11540. In one embodiment of the present technology, when the tab 11024 enters the receiving space 11540, the tab surface can slide along the inner surface of the receiver 11520. Those skilled in the art will recognize this process as the tab 11024 being engaged with the latch 3800-5.

[0480] Figure 11C An exemplary engaged state of the headgear connector 3600-5 is illustrated. In one example, engagement of the tab 11024 may be accompanied by auditory and / or tactile feedback that can be perceived by the patient, informing the patient that the headgear connector 3600-5 and the strap have been securely engaged to the remainder of the patient interface. Similar tactile and / or auditory feedback may be generated when the latch 3800-5 and the retainer 3700-5 disengage.

[0481] like Figure 11C As shown, when the head connector 3600-5 is in the engaged state, the tab 11024 can be engaged into the receiving space 11540, such that most of the tab surface faces the surface of the receiver 11520. In one embodiment of this technology, the first edge 11008B of the first base wall 11008 can be adjacent to or nearly adjacent to the second stop device 11514. Similarly, the second edge 11508B of the second base wall 11508 can be adjacent to or nearly adjacent to the first stop device 11014.

[0482] When a patient wears the patient interface 3000-5, for example, during movement while awake and / or asleep, the exemplary configuration of the receiver 11520 and the tab 11024 allows the latch 3800-5 to rotate around the tab 11024 and relative to the retainer 3700-5. If the relative rotation of the headpiece connector 3600-5 is not accommodated, some movement by the patient that may result in such rotation will cause a certain pulling or other force to be applied to the patient by one or more parts of the patient interface. Furthermore, if the limited rotation between the latch 3800-5 and the retainer 3700-5 is not permitted according to the present technology, the patient may experience varying degrees of discomfort. In some aspects, if relative rotation between the latch 3800-5 and the retainer 3700-5 is not permitted, the force applied during movement may cause the latch 3800-5 and the retainer 3700-5 to disengage, resulting in the patient interface becoming unintentionally loose or detached, which may interrupt the intended delivery of treatment. Therefore, such movements may not be noticed by the patient or usually not be considered a nuisance, and / or may reduce the occurrence of accidental loosening or detachment of the patient interface.

[0483] 5.3.3.4.6 Vertical slider mechanism

[0484] Figure 12A A headgear connector 3600-6 in a disengaged state, according to this technology, is shown. Figure 12A As shown, the headgear connector 3600-6 includes a retainer 3700-6 and a snap fastener 3800-5. As described in more detail below, the snap fastener 3800-6 can be configured to engage and secure to the retainer 3700-6 according to an engagement type, which can be mechanical and may in some respects lack any magnetic components. The retainer 3700-6 includes a first body 12000 defining a slot 12010A that forms a concave engagement structure as a first engagement structure 12010. The first engagement structure 12010 includes at least one notch 12020 defined in a first surface 12012. Figure 12A In the illustrated example, the first engagement structure 12010 may include two notches, one visible and one invisible, such as... Figure 12A The corresponding positions are located on the opposite sides of the slot 12010A defined by the first surface 12012. In one embodiment, the first surface 12012 defines the slot 12010A, which can be configured to receive the rod 12512 of the latch 3800-6.

[0485] The latch 3800-6 may include a crossbar 12504 and a second body 12500, the second body defining a convex engagement structure as a second engagement structure 12510. As defined by the second body 12500, the second engagement structure 12510 may include a rod 12512 and at least one protrusion 12520 (e.g., a bump) extending from the surface of the rod 12512. Figure 12A In the illustrated example, two protrusions 12520 may be provided at corresponding positions on opposite sides of the rod 12512, one of which is in Figure 12A One is visible, and the other is not. These protrusions can be positioned to engage with the notch 12020 of the retainer 3700-6 in the following situations: (1) the rod 12512 is aligned with the slot 12010A; (2) the latch 3800-6 moves toward the retainer 3700-6 in the engagement direction E; (3) the rod 12512 slides along the first surface 12012 of the first engagement structure 12010 until the protrusion 12520 engages the notch 12020. Thus, in one form, the second engagement structure 12510 may include the rod 12512, which is configured to move into a structure defined on or in the surface of the first body 12000 (the first surface 12012) or in the surface (the structure defining the slot 12010A), such that the first engagement structure 12010 can define a concave engagement structure.

[0486] Despite the combination Figure 12A and Figure 12B Two protrusions 12520 and two notches 12020 are described, but it is conceivable that one, three, four or more protrusions 12520 and notches 12020 may be included on the snap fastener 3800-6 and the retainer 3700-6. Furthermore, although the crossbar 12504 is described as part of the snap fastener 3800-6, one or more slots, sliders or other suitable mechanisms may be used, through which straps may be routed or passed and secured to the snap fastener 3800-6.

[0487] In the illustrated example, the second surface 12014 of the first engagement structure 12010 may be defined by the first body 12000, and thus define the closed end of the slot 12010A. In one form of the present technology, the engagement between the first engagement structure 12010 and the second engagement structure 12510 may include: a stop 12514 engaging the end face of the rod 12512 with the second surface 12014. Due to this engagement, further movement of the rod 12512 in the engagement direction E is restricted, and the headgear connector 3600-6 moves into and remains as... Figure 12B The exemplary engagement state is illustrated.

[0488] Feedback can be used to indicate the engagement or disengagement of the latch 3800-6 and retainer 3700-6. This feedback sends a signal to the patient notifying them that the latch 3800-6 and retainer 3700-6 are engaged, disengaged, or indicating either condition. For example, when removing the latch 3800-6 from... Figure 12A The disengaged state shown moves to Figure 12B In the exemplary engagement state shown, the protrusion 12520 can be engaged in place within the corresponding recess 12020 (and thus the rod 12512 engages in the slot 12010A). This can generate one or both of auditory and tactile feedback to the patient. A clicking sound can be produced in the position where the protrusion 12520 / rod 12512 is engaged within the recess 12020 / slot 12010A, which can serve as notification that engagement has been completed. In terms of tactile feedback, the patient can feel overcoming the frictional resistance thus exerted by the first surface 12012 on the protrusion 12520, or reducing the vibrations caused thereby. Additionally or alternatively, the patient can feel the impact of the stop 12514 contacting the second surface 12014. When the latches 3800-6 and the retainer 3700-6 are disengaged, reverse interaction can similarly provide one or both of auditory and tactile feedback.

[0489] 5.3.4 Modularization

[0490] As described above, the pads, hoods, and sleeves can come in different styles to correspond to different uses (e.g., mouth breathing, nasal breathing, etc.). Patients or clinicians can select certain combinations of pads, hoods, sleeves, and hood connectors to optimize the effectiveness of the therapy and / or individual patient comfort. An example of such a modular design is described in PCT / SG2022 / 050777, filed October 28, 2022, which is incorporated herein by reference in its entirety.

[0491] In some forms, different styles of pads, caps, sleeves, and cap connectors can be used interchangeably to create different combinations of patient interfaces. This can be advantageous from a manufacturing perspective, as fewer parts can be used to produce a greater variety of patient interfaces. Additionally or alternatively, various combinations can allow patients to change the type of patient interface without altering each component.

[0492] Air can be delivered to the patient in one of two main ways. In one example, the patient can be delivered through a head cannula 3350 (see example...). Figure 3Y , Figure 6C , Figure 6H(and Figure 7) Receives a pressurized airflow. This can be referred to as a "tube-up" configuration, and the connection port can be positioned at the top of the patient's head. In other examples, the patient can be connected via a catheter to the inflation chambers 3200, 3200-5 (e.g., via a connection to the ventilation ports 3400, 3400-5 (see example...)). Figure 3A The connection port 3470, which is fluidly connected to the connection port in Figure 22, receives a pressurized airflow. This can be referred to as a "tube-down" configuration, where the airflow duct is positioned in front of the patient's face. Different patients may be more comfortable using one style of air delivery than another (e.g., due to the patient's sleeping posture). Therefore, it may be beneficial to allow the use of a single style of patient interface in either a "tube-up" or "tube-down" configuration.

[0493] The patient interface can be part of a modular component with various interchangeable parts, which patients and / or clinicians can swap out for one or more components of different types. The following description illustrates the various combinations that can be produced by assembling the different parts together.

[0494] 5.3.4.1 Sleeve

[0495] In some forms, to allow for modularity, sleeves (such as the catheter sleeve 3351 discussed above) can be used with the tube 3350 and / or the hardener arm 3340. As mentioned above, the sleeve can at least partially surround the tube 3350 and / or the hardener arm 3340; and sleeves of different shapes can be used (see, for example...). Figure 6G and Figure 6H The exemplary catheter sleeve 3351 depicted herein. In some forms, different shapes may correspond to different types of positioning and stabilization structures 3300. Furthermore, in some forms, the sleeve configuration may be customized to fit the face of a particular user. For example, the sleeve may be constructed in a relatively posterior region of the patient's head.

[0496] In some forms, the sleeve can be constructed from comfort materials. For example, the sleeve can be constructed from textile materials, foam materials, or a combination of both. Comfort materials come into contact with the patient during use and feel soft against the patient's skin, thereby improving patient compliance.

[0497] The material can also be flexible to facilitate putting on or taking off the sleeve from the tube 3350 or the hardener arm 3340. For example, the material may allow the sleeve to bend to conform to the shape of the tube 3350, other catheter tip components, or the hardener arm 3340, which can be modified according to the shape of an individual patient's head.

[0498] In some forms, the sleeve may also be at least partially elastic (e.g., the material may allow the sleeve to stretch). The elastic material can help the sleeve stretch to fit around the tube 3350 or hardener arm 3340. The elastic material can then return to its initial position, which is in close contact with the tube 3350 or hardener arm 3340, to limit sleeve slippage during use.

[0499] Some types of sleeves may be specific to rigid elements (e.g., tube 3350 and / or hardener arm 3340). However, sleeves can facilitate interchangeable connection of rigid elements with various versions or styles of pads (e.g., nose pad 3050-1, pure nose pad 3050-2, etc.).

[0500] 5.3.4.2 Assembled Patient Interface

[0501] The various components described above can be combined to form different patient interfaces. Different patient interfaces allow patients to use different styles based on their individual comfort levels. The modularity of different components (e.g., the ability to use multiple types of patient interfaces) can simplify manufacturing and / or allow patients to switch more easily between multiple types of patient interfaces.

[0502] 5.4RPT device

[0503] According to one aspect of the present technology, the RPT device 4000 includes mechanical, pneumatic, and / or electrical components and is configured to perform one or more algorithms, such as any of the methods described herein, in whole or in part. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0504] In one embodiment, the RPT device 4000 is configured and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0505] The RPT device may have an outer housing 4010, which is formed in two parts: an upper portion 4012 and a lower portion 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0506] The pneumatic path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet silencer 4124, and one or more transducers 4270, such as pressure sensors and flow sensors.

[0507] One or more air path items may be located within a removable integral structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be located within an outer housing 4010. In one form, pneumatic block 4020 is supported by or formed as part of a chassis 4016.

[0508] like Figure 4A As shown, the RPT device 4000 may include a power supply 4210, one or more input devices 4220, a pressure generator 4140, and a power component 4200. The power component 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In one example, the power component 4200 may include... Figure 4B The transducer 4270 shown, along with several components not shown, may include a central controller, a therapy device controller, one or more protection circuits, a memory, a data communication interface, and one or more output devices. Alternatively, the RPT device 4000 may include more than one PCBA 4202.

[0509] 5.4.1 Mechanical and pneumatic components of the RPT device

[0510] The RPT device may include one or more of the following components in an overall unit. In an alternative form, one or more of the following components may be positioned as respective separate units.

[0511] 5.4.1.1 Air Filter

[0512] One form of RPT device according to the present technology may include an air filter 4110 or a plurality of air filters 4110.

[0513] exist Figure 4B In one embodiment, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0514] exist Figure 4B In one embodiment, an outlet air filter 4114, such as an antibacterial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000.

[0515] 5.4.1.2 Muffler

[0516] One form of RPT device according to the present technology may include one or more mufflers 4120.

[0517] In one form of this technology (see, for example, see...) Figure 4B The inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0518] In one embodiment of this technology, the outlet silencer 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0519] 5.4.1.3 Pressure Generator

[0520] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. The blower may deliver an air supply, for example, at a rate up to about 120 liters per minute and at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O, when delivering respiratory pressure therapy. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013 / 020167.

[0521] The pressure generator 4140 can be controlled by the therapeutic device controller (not shown).

[0522] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

[0523] 5.4.1.4 Transducer

[0524] The transducer can be inside or outside the RPT device. An external transducer can be located on, for example, an air circuit (e.g., a patient interface) or form part of an air circuit. The external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to or from the RPT device.

[0525] In one form of this technology (see example) Figure 4BOne or more transducers 4270 are located upstream and / or downstream of pressure generator 4140. One or more transducers 4270 may be configured and arranged to generate signals representing properties of airflow, such as velocity, pressure, or temperature at that point in the aerodynamic path.

[0526] In one form of this technology, one or more transducers 4270 may be located near the patient interface 3000.

[0527] In one configuration, the signal from transducer 4270 can be filtered, such as by low-pass, high-pass, or band-pass filtering.

[0528] 5.4.1.5 Anti-overflow valve

[0529] like Figure 4B As shown, in one form of this technology, an anti-backflow valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0530] 5.4.2 Power Components of RPT Device

[0531] 5.4.2.1 Power Supply

[0532] The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.

[0533] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of this technology, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.

[0534] 5.4.2.2 Input Device

[0535] In one form of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow human interaction with the device. The buttons, switches, or dials can be physical or software devices accessible via a touchscreen. The buttons, switches, or dials can be physically connected to an external housing 4010 in one form, or wirelessly communicate with a receiver electrically connected to a central controller, which may be attached to the power supply unit 4200.

[0536] In one form, the input device 4220 may be configured and arranged to allow a person to select values ​​and / or menu options.

[0537] 5.5 Humidifier

[0538] 5.5.1 Humidifier Overview

[0539] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 5A (As shown), to change the absolute humidity of the air or gas intended to be delivered to the patient relative to ambient air. Typically, a humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0540] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering a humidified airflow. In some forms, such as Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which may be adapted to accommodate the humidifier reservoir 5110 and include a heating element 5240.

[0541] 5.6 Glossary

[0542] To achieve the purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of this technology. In other forms of this technology, alternative definitions may be applied.

[0543] 5.6.1 General Terminology

[0544] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-enriched air.

[0545] Environment: In some forms of this technology, the term environment is considered to mean (i) the exterior of the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0546] For example, the ambient humidity relative to a humidifier can 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.

[0547] In another example, environmental stress can be stress that is either close to the body or outside the body.

[0548] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the room where the patient is located, rather than noise generated, for example, by the RPT device or emitted from the mask or patient interface. Ambient noise may be generated by sources outside the room.

[0549] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum (e.g., varying with each breath) depending on the presence of an indication of an SDB event.

[0550] Continuous positive airway pressure (CPAP) therapy: a 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 is slightly higher during exhalation and slightly lower during inhalation. 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.

[0551] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be a scalar quantity, that is, a quantity that only has magnitude. In other cases, the reference to flow rate will be a vector quantity, that is, a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. "Flow rate" is sometimes simply abbreviated as "flow rate" or "airflow".

[0552] In the example of patient breathing, the flow rate may be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Device flow rate Qd is the flow rate of air leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. Ventilation flow rate Qv is the flow rate of air leaving the vent to allow flushing of exhaled gas. Leakage flow rate Ql is the flow rate leaking from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received from the patient's respiratory system.

[0553] Flow therapy: This includes respiratory therapy that delivers a controlled flow of air to the airway inlet at a rate known as therapeutic flow, which is typically positive throughout the patient’s respiratory cycle.

[0554] Humidifier: The term humidifier will be considered to refer to a humidifying device that is constructed and arranged or has a physical structure to provide a therapeutically beneficial amount of water (H2O) vapor to an airflow to alleviate a patient’s medical respiratory symptoms.

[0555] 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 might occur in a swivel bend leading to the environment.

[0556] Conducted noise (acoustic): In this document, conducted noise refers to noise transmitted to the patient through pneumatic paths, 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.

[0557] Radiated noise (acoustics): In this document, radiated noise refers to noise transmitted to the patient by ambient air. In one form, radiated noise can be quantified according to ISO 3744 by measuring the sound power / sound pressure level of the object under discussion.

[0558] Vent noise (acoustic): Vent noise in this document refers to the noise generated by the airflow through any vent (such as the vent hole of a patient interface).

[0559] Oxygen-enriched air: Air with an oxygen concentration greater than that of atmospheric air (21%), for example, at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. “Oxygen-enriched air” is sometimes abbreviated as “oxygen”.

[0560] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0561] Patient: A person, regardless of whether they have a respiratory illness.

[0562] 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 And it is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m). 2 = 1 millibar to 0.001 atmospheres. In this specification, unless otherwise stated, pressure is given in cmH2O.

[0563] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained through the interface pressure Pm at the current moment.

[0564] Respiratory pressure therapy: Applying an air supply to the airway entrance at a therapeutic pressure that is normally positive relative to the atmosphere.

[0565] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0566] 5.6.1.1 Materials and their properties

[0567] Hardness: refers to the hardness of a hardness tester or indentation hardness, which is a material property measured by indentation through an indenter (e.g., as measured according to ASTM D2240).

[0568] • "Soft" materials can include silicone resins or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0569] • "Hard" materials can include polycarbonate, polypropylene, and can be resistant to deformation, for example, under finger pressure.

[0570] Silicone resin or silicone elastomer: synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or compression-molded silicone rubber (CMSR). One commercially available form of LSR is SILASTIC, manufactured by Dow Corning (included in the product range sold under this trademark). Another manufacturer of LSR is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0571] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0572] 5.6.1.2 Mechanical Axis:

[0573] o. Neutral axis: An axis in the cross-section of a beam or plate that has no longitudinal stress or strain.

[0574] p. Longitudinal axis: An axis that extends along the length of a shape. This axis typically passes through the center of the shape.

[0575] q. Circumferential axis: An axis oriented perpendicularly to the longitudinal axis. This axis can specifically exist in pipes, tubes, cylinders, or similar shapes with circular and / or elliptical cross-sections.

[0576] Deformation: The process by which the original geometry of a component changes when subjected to a force (e.g., a force in the direction relative to an axis). This process can include stretching or compression, bending, and twisting.

[0577] Elasticity: The ability of a material to return to its original geometry after deformation.

[0578] Flexible structures or components: structures or components that will change shape (e.g., bend) when made to support their own weight for a relatively short period of time, such as 1 second.

[0579] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0580] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain silicone resins and thermoplastic elastomers.

[0581] Rigid structure or component: A structure or component that will not substantially change shape when subjected to the loads typically encountered in use. An example of such use could be, for instance, setting up and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway under a load of approximately 20 to 30 cmH2O.

[0582] As an example, an I-beam may include 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 soft in the first direction and rigid in the second direction.

[0583] 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. The opposite of stiffness is flexibility.

[0584] Viscosity: The ability of a material to resist flow.

[0585] Viscoelasticity: The ability of a material to exhibit both elastic and viscous behavior during deformation.

[0586] Yield: The condition where a material, after being deformed, no longer returns to its original geometry.

[0587] 5.6.1.3 Structural Components

[0588] Compression component: A structural element that resists compressive forces.

[0589] Bend: A bend is an example of a structure that guides the axis of an airflow traveling through it to change direction by an angle. In one form, this angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. A bend can have a generally 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, about 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 onto the mating component during manufacturing via a disposable snap-fit, but cannot be removed by the patient.

[0590] Frame: The frame is generally considered to refer to the mask structure that bears the tensile load between two or more connection points to the hood. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0591] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0592] Lacing (noun): A structure designed to resist tension.

[0593] Thin structure:

[0594] r. beam,

[0595] i. Compared to the other two dimensions, the beam can be relatively long in one dimension, making the smaller dimension relatively thinner compared to the longer dimension.

[0596] s. membrane,

[0597] i. Relatively long in two dimensions and relatively thin in one dimension. Easily deforms in response to bending forces. Resistant to tension (and possibly compression).

[0598] t. Plates and shells

[0599] i. They can be relatively long in two directions and relatively thin in one dimension. They can have bending, tensile, and / or compressive stiffness.

[0600] Thick structure: solid

[0601] Sealing: can be the noun form referring to a structure ("seal") or the verb form referring to an effect ("seal"). Two elements can be constructed and / or arranged to "seal" or to achieve "seal" between them without the need for a separate "seal" element itself.

[0602] Shell: A shell is generally considered to refer to a curved, relatively thin structure with bending, tensile, and compressive stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0603] Reinforcement: Reinforcement is considered to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0604] Column: A column is considered a structural component designed to increase the compressive strength of another component in at least one direction.

[0605] Rotary shaft (noun): A sub-assembly of a component configured to rotate, preferably independently, about a common axis, preferably under low torque. In one form, the rotary shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the rotary shaft may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery conduits, the sub-assembly of the component preferably comprises a pair of mating cylindrical conduits. In use, there may be little or no airflow leaking from the rotary shaft.

[0606] 5.6.2 Respiratory cycle

[0607] Apnea: According to some definitions, apnea is considered to have occurred when airflow drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when, despite the patient's efforts, some form of airway obstruction prevents airflow. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with an obstructed airway.

[0608] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured as the number of breaths per minute.

[0609] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0610] Effort (breathing): The work done by a person who breathes voluntarily in an attempt to breathe.

[0611] The expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0612] Flow restriction: Flow restriction is considered a state of respiratory function in which increased effort by the patient does not result in a corresponding increase in flow. If flow restriction occurs during the inspiratory portion of the respiratory cycle, it can be described as inspiratory flow restriction. If flow restriction occurs during the expiratory portion of the respiratory cycle, it can be described as expiratory flow restriction.

[0613] Types of flow-limited inhalation waveforms:

[0614] (i) Flat-topped: First rises, then a relatively flat section, and then falls.

[0615] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.

[0616] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.

[0617] (iv) Inverted chair shape: has a relatively flat section followed by a single local peak at the trailing edge.

[0618] Insufficient breathing: Under certain conditions, insufficient breathing is considered a reduction in flow, not an interruption of flow. In one form, insufficient breathing is considered to have occurred when the flow rate drops below a threshold rate for a sustained 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:

[0619] (i) The patient's breathing decreases by 30% for at least 10 seconds, plus an associated 4% desaturation; or

[0620] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% associated desaturation or arousal.

[0621] Hyperventilation: The flow rate increases to a level higher than normal.

[0622] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0623] Airway patency: The degree to which the airway is open or the extent to which the airway is open. A patent airway is open. Airway patency can be quantified, for example, a value of one (1) indicates patentness, and a value of zero (0) indicates closure (obstruction).

[0624] Positive end-expiratory pressure (PEEP): Pressure above atmospheric pressure present in the lungs at the end of expiration.

[0625] Peak flow (Qpeak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0626] Respiratory flow, patient airflow, and 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,” which is the actual respiratory flow rate experienced by the patient, usually expressed in liters per minute.

[0627] 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), and 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.

[0628] Inhalation time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0629] Exhalation time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0630] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of a respiratory flow waveform and the start of the inspiratory portion of a subsequent respiratory flow waveform.

[0631] Typical recent ventilation: Vent values ​​tend to cluster around their clusters within a predetermined time range; that is, a measure of the central tendency of recent ventilation values.

[0632] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or may even decrease as the pressure differential across the upper airway increases (Starling resistance behavior).

[0633] Ventilation: A measurement of the total amount of gas exchanged by a patient's respiratory system. Ventilation can be measured by one or both of inspiratory flow rate and expiratory flow rate (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given in volume and is understood as volume per minute.

[0634] 5.6.3 Anatomy

[0635] 5.6.3.1 Facial Anatomy

[0636] Alar: The outer wall or "wing" of each nostril (plural: alar)

[0637] Nasal wing angle: The angle formed between the nasal wings of each nostril.

[0638] Alar tip: the outermost point on the ala of the nose.

[0639] Alar curvature (or alar ridge) point: the last point in the curvature baseline of each alar, found in the crease formed by the connection between the alar and the cheek.

[0640] Auricle: The entire visible external part of the ear.

[0641] (Nasal) Bone framework: The bony framework of the nose includes the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0642] (Nasal) Cartilaginous Framework: The cartilaginous framework of the nose includes the septal cartilage, lateral cartilage, major cartilage, and minor cartilage.

[0643] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0644] Columellar angle: The angle between a line drawn through the midpoint of the nostril cavity and a line drawn perpendicular to the Frankfurt horizontal plane and intersecting the subnasal point.

[0645] Frankfurt Plane: A line extending from the lowest point of the orbital margin to the left tragus point. The tragus point is the deepest point in the notch above the tragus of the auricle.

[0646] The glabella is the most prominent point in the midsagittal plane of the forehead, located on the soft tissue.

[0647] Lateral nasal cartilage: a roughly triangular cartilaginous plate. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0648] Lower lip (midpoint of the lower lip): The lip that extends between the point below the nose and the mouth.

[0649] Upper lip (midpoint of the upper lip): The lip that extends between the mouth and the supramental point.

[0650] Greater alar cartilage: A cartilaginous plate located beneath the lateral nasal cartilage. It curves around the anterior portion of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane, which contains three or four small cartilages of the alar.

[0651] Nostrils (nares / nostrils): Roughly oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils (nares) is nasal nasal (naris / nostril). Nostrils are separated by the nasal septum.

[0652] 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.

[0653] Nasolabial angle: The angle between the columella and the upper lip (which intersect at the subnasal point).

[0654] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0655] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0656] 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.

[0657] The philtrum is a midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0658] Prechin point: Located on the soft tissue, at the very front midpoint of the chin.

[0659] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0660] Sagittal plane: A vertical plane running from front to back. The midsagittal plane is the sagittal plane that divides the body into left and right halves.

[0661] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0662] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0663] Lower edge of the nasal ala: The point at the lower edge of the base of the nasal ala, where the base of the nasal ala connects with the skin of the upper (upper) lip.

[0664] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the mid-sagittal plane.

[0665] Supramental point: The point with the greatest concavity located on the midline of the lower lip, between the midpoint of the lower lip and the premental point of the soft tissue.

[0666] Skull Anatomy

[0667] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0668] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.

[0669] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the orbit. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral border.

[0670] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary among individuals; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0671] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the depression at the top of the bridge of the nose.

[0672] Occipital bone: The occipital bone is located in the dorsal and lower parts of the skull. It includes the foramen magnum, an oval-shaped cavity through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0673] The eye socket is the bony cavity in the skull that houses the eyeball.

[0674] Parietal bone: The parietal bone is the skeleton that forms the top and sides of the skull when they are joined together.

[0675] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0676] Cheekbones: The face consists of two cheekbones, which are located on the upper and outer parts of the face and form the protrusions of the cheeks.

[0677] 5.6.3.2 Respiratory System Anatomy

[0678] Diaphragm: A muscular sheet 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.

[0679] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0680] Lungs: The human respiratory organs. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0681] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located above and behind the nose in the middle of the face. It is divided into two parts by a vertical wing called the nasal septum. On either side of the nasal cavity are three horizontal branches called nasal conchae (singular "concha") or nasal bones. The anterior part of the nasal cavity is the nasal part, while the posterior part connects to the nasopharynx via the posterior nasal aperture.

[0682] 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 segments: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0683] 5.6.4 Patient Interface

[0684] Anti-asphyxiation valve (AAV): A component or sub-assembly of a mask system that reduces the risk of a patient rebreathing excessive CO2 by opening to the atmosphere in a fail-safe manner.

[0685] Headgear: Headgear is considered to refer to a form of positioning and stabilizing structure designed to hold a device (such as a mask) on the head.

[0686] Inflation chamber: The mask inflation chamber is considered to refer to a portion of the patient interface having walls that at least partially enclose a volume of space, which, in use, contains air pressurized to above atmospheric pressure. An outer shell may form part of the wall of the mask inflation chamber.

[0687] Sealing: can be the noun form referring to a structure ("seal") or the verb form referring to an effect ("seal"). Two elements can be constructed and / or arranged to "seal" or to achieve "seal" between them without the need for a separate "seal" element itself.

[0688] Ventilation port: (noun): A structure that allows air to flow from the inside of a mask or conduit into ambient air for clinically effective flushing of exhaled gases. For example, depending on the mask design and treatment pressure, clinically effective flushing can involve a flow rate from approximately 10 liters per minute to approximately 100 liters per minute.

[0689] 5.6.5 Structural Shape

[0690] Products according to this technology may include one or more three-dimensional mechanical structures, such as mask liners or impellers. The three-dimensional structure may be defined by two-dimensional surfaces. These surfaces may be distinguished using labels to describe associated surface orientation, location, function, or other characteristics. 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 seal-forming structure may include a face-contact (e.g., external) surface and separate non-face-contact (e.g., underside or inner) surfaces. In yet another example, the structure may include a first surface and a second surface.

[0691] To facilitate the description of the shape of three-dimensional structures and surfaces, we first consider the cross-section through the surface of the structure at point p. See [link to documentation]. Figures 3B to 3F These figures illustrate examples of cross-sections at point p on a surface, and the resulting planar curves. Figures 3B to 3F The outward normal vector at point p is also illustrated. The outward normal vector at p points away from the surface. In some examples, we describe the surface from the perspective of an imaginary little person standing upright on the surface.

[0692] 5.6.5.1 One-dimensional curvature

[0693] The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and magnitude (e.g., 1 / radius of the circle that just touches the curve at p).

[0694] Positive curvature: If the curve at point p turns towards the outward normal, then the curvature at that point will be taken as positive (if you imagine little figures leaving point p, they must walk uphill). See also Figure 3B (and Figure 3C Compared to a relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to a relatively small positive curvature). Such curves are often referred to as concave curves.

[0695] 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 .

[0696] 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 be going downhill). See also Figure 3E (and Figure 3F Compared to a relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to a relatively large negative curvature). Such curves are often referred to as convex curves.

[0697] 5.6.5.2 Curvature of Two-Dimensional Surfaces

[0698] The description of the shape at a given point on a two-dimensional surface according to this technique may include multiple normal cross sections. These cross sections may cut the surface in a plane including an outward normal (“normal plane”), and each cross section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has, for example, a relatively small magnitude. Figures 3B to 3F A planar curve in a diagram can be an example of multiple cross-sections at a specific point.

[0699] 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 curvature appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross-section along the principal direction. The principal curvature at point p is the curvature along the principal direction.

[0700] Surface region: The set of connection points on a surface. This set of points within a region can have similar characteristics, such as curvature or sign.

[0701] Saddle-shaped region: The region where the principal curvature has opposite signs at each point, that is, one is positive and the other is negative (depending on the direction the imagined person is turning, they may be going uphill or downhill).

[0702] Vault region: The region where the principal curvature has the same sign at each point, such as both being positive ("recessed vault") or both being negative ("convex vault").

[0703] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0704] Planar region: A surface region in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0705] Edge of a surface: the boundary or limit of a surface or region.

[0706] 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 distance, including, for example, a set of points on a surface. (The path of an imagined person is the place where they walk on the surface, and is similar to a garden path).

[0707] Path length: In some forms of this technique, "path length" will be considered to mean 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 person would be the distance they must walk along the path on the surface).

[0708] Straight-line distance: Straight-line distance is the distance between two points on a surface, but it is independent of the surface itself. On a planar region, there will exist paths on the surface with the same path length as the straight-line distance between the two points. On a non-planar surface, there may not be paths with the same path length as the straight-line distance between the two points. (For the imaginary, straight-line distance will correspond to the distance "in a straight line.")

[0709] 5.6.5.3 Space Curves

[0710] Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, meaning they have no endpoints. A space curve can be thought of as a one-dimensional segment of three-dimensional space. Imagine a person walking along a space curve on one strand of a DNA helix. The typical human left ear contains the helix, which is a left-handed helix; see [link to relevant documentation]. Figure 3Q The typical human right ear includes a spiral, which is a right-handed spiral; see [link / reference]. Figure 3R . Figure 3S A right-handed helix is ​​shown. The edges of a structure, such as the edges of a membrane or impeller, can follow a space curve. 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.

[0711] 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 tangential unit vector is a unit vector pointing in the same direction as the curve at that point. If you imagine a person flying along a curve and falling from their aircraft at a specific point, the direction of the tangent vector is the direction they would have traveled.

[0712] Unit normal vector: When an imagined person moves along a curve, the tangent vector itself also changes. The unit vector that changes in the same direction as the tangent vector is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0713] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see example...). Figure 3P ) or alternatively, by the left-hand rule ( Figure 3O To determine.

[0714] Occult plane: A plane containing both the unit tangential vector and the unit principal normal vector. See also Figure 3O and Figure 3P .

[0715] Torque of a space curve: Torque at a point on a space curve 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 its osculating plane. A space curve lying in a plane has zero torque. A space curve deviating relatively small from its osculating plane will have a relatively small torque (e.g., a gently sloping spiral path). A space curve deviating relatively large from its osculating plane will have a relatively large torque (e.g., a sharply sloping spiral path). See also Figure 3S Since T2 > T1, therefore Figure 3S The twist near the top coil of the spiral is greater than Figure 3S The size of the twist of the bottom coil of the spiral.

[0716] refer to Figure 3P According to the right-hand rule, a space curve turning toward the right-hand secondary normal direction can be considered to have a right-hand positive twist (e.g., Figure 3S (The right-handed spiral shown). A spatial curve that turns away from the right-handed secondary normal direction can be considered to have a right-handed negative twist (e.g., a left-handed spiral).

[0717] Similarly, refer to the left-hand rule (see...) Figure 3O A space curve that turns toward the left-hand secondary 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 .

[0718] 5.6.5.4 holes

[0719] 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 example. Figure 3I The structure shown has a one-dimensional hole defined by a planar curve on its surface.

[0720] 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 example Figure 3L padding and Figure 3M and Figure 3N An example cross-section through the liner is shown, indicating the inner surface defining the two-dimensional orifice. In yet another example, the conduit may include a one-dimensional orifice (e.g., at its inlet or outlet) and a two-dimensional orifice defined by the inner surface of the conduit. See also Through Figure 3K The structure shown has a two-dimensional hole defined by the surface shown.

[0721] 5.7 Other Remarks

[0722] This patent document contains a portion of copyrighted material. The copyright holder does not object to any fax copying of the patent document or patent disclosure appearing in the patent office's patent documents or records, but otherwise reserves all copyright rights.

[0723] Unless the context clearly indicates otherwise and a range of values ​​is provided, it should be understood that every intermediate value (to one-tenth of the lower limit unit) between the upper and lower limits of the range, as well as any other said or intermediate values ​​within the range, are covered by this technique. The upper and lower limits of these intermediate ranges (which may be independently included in the intermediate range) are also covered by this technique, but are subject to any explicit exclusions within the range. Where the range includes one or both of these limitations, the range excluding any one or both of those included limitations is also included in this technique.

[0724] Furthermore, where one or more values ​​described herein are implemented as part of this technology, it should be understood that, unless otherwise stated, such values ​​may be approximate and may be used for any suitable significant number to the extent that the actual technical implementation may allow or require.

[0725] Furthermore, as used herein, “approximately,” “substantially,” “about,” or any similar terms mean + / - 5-10% of the stated values.

[0726] 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 technology pertains. While 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 exemplary methods and materials are described herein.

[0727] When a particular material is identified for use in constructing a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein should be understood as capable of being manufactured, and therefore can be manufactured together or separately.

[0728] It should be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents, unless the context clearly indicates otherwise.

[0729] All publications mentioned herein are incorporated 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 solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present technology is not entitled to any prior disclosure by virtue of a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0730] The terms “comprising” and “including” should be interpreted as referring to an element, component or step in a non-exclusive manner, indicating that the referenced element, component or step may be present, used or combined with other elements, components or steps not expressly referenced.

[0731] The headings used in the detailed embodiments are for convenience of the reader only and should not be used to limit the subject matter found throughout this disclosure or the claims. The headings should not be used to interpret the claims or to limit the scope of the claims.

[0732] Although the techniques described herein have been illustrated with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may imply specific details that are not required for practicing the techniques. For example, although the terms “first” and “second” may be used, they are not intended to indicate any order unless otherwise stated, but may be used to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such sequence is not required. Those skilled in the art will recognize that such sequence can be modified and / or aspects thereof can be performed simultaneously or even concurrently.

[0733] Therefore, it should be understood that numerous modifications can be made to the exemplary examples and other arrangements can be designed without departing from the spirit and scope of this technology.

[0734] 5.8 List of reference numerals

[0735]

[0736]

[0737]

[0738]

[0739]

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[0741]

Claims

1. A headgear connector, comprising: a retainer comprising a first engagement structure and configured to connect to a patient interface; and a buckle comprising a second engagement structure and configured to connect to a strap of the patient interface, wherein one of the first engagement structure or the second engagement structure comprises a female engagement structure, wherein the other of the first engagement structure and the second engagement structure comprises a male engagement structure, wherein the male engagement structure comprises a stem protruding from a surface and a plurality of deflectable prongs protruding from the surface and positioned around the stem, wherein the female engagement structure comprises a receptacle defining an opening, wherein the headgear connector is configured to transition between an engaged state in which the buckle is coupled to the retainer and a disengaged state in which the buckle is decoupled from the retainer, and wherein, in the engaged state, the male engagement structure is housed within the female engagement structure.

2. The headgear connector of claim 1, wherein the retainer comprises the male engagement structure and the buckle comprises the female engagement structure.

3. The headgear connector of claim 1 or 2, wherein the opening of the receptacle extends completely through a first surface and a second surface opposite the first surface.

4. The headgear connector of any one of claims 1 to 3, wherein a height of the male engagement structure is greater than a height of the opening such that the male engagement structure extends through the opening in the engaged state.

5. The headgear connector of claim 1 or 2, wherein the opening of the receptacle extends through a first surface and terminates prior to a second surface opposite the first surface.

6. The headgear connector of any one of claims 1 to 5, wherein the male engagement structure comprises two, three, or four deflectable prongs protruding from the surface and around the stem.

7. The headgear connector of any one of claims 1 to 6, wherein transitioning to the engaged state requires a force of about 1.0 N to about 30.0 N.

8. The headgear connector of any one of claims 1 to 7, wherein transitioning from the engaged state to the disengaged state requires a force of about 1.0 N to about 60.0 N.

9. The headgear connector of any one of claims 1 to 8, wherein the receptacle has a first receptacle surface, a second receptacle surface, and a receptacle transition between the first receptacle surface and the second receptacle surface, wherein the receptacle transition protrudes more deeply into the opening of the receptacle than the first receptacle surface and the second receptacle surface.

10. The headgear connector of any one of claims 1 to 9, wherein each prong of the plurality of prongs comprises a ridge protruding outward on a side of the prong facing away from the stem.

11. The headgear connector of any one of claims 1 to 8, wherein: the receptacle transition is more deeply protruding into the opening of the receptacle than the first receptacle surface and the second receptacle surface, each of the plurality of posts includes a ridge protruding outward on a side of the post facing away from the stem, and when the headgear connector is transitioned to the engaged state, as the male engagement structure is received in the female engagement structure, the outwardly protruding ridge on each of the plurality of posts contacts the receptacle transition, causing the plurality of posts to deflect inward toward the stem.

12. The headgear connector of claim 11, wherein in the engaged state, the outwardly protruding ridge of each of the plurality of posts is more deeply located in the receptacle than the receptacle transition.

13. The headgear connector of any one of claims 1 to 12, wherein the retainer is removably coupled to the patient interface.

14. The headgear connector of any one of claims 1 to 13, wherein the clasp is removably coupled to the strap of the patient interface.

15. The headgear connector of any one of claims 1 to 14, wherein at least one of the clasp and the retainer includes at least one of a dimple, a bump, a groove, a notch, a serration, a ridge, knurling, or a texture on a portion configured to be contacted by a patient.

16. A patient interface, comprising: a headgear including a first strap and a second strap; a seal-forming structure; and the headgear connector of any one of claims 1 to 15.

17. The patient interface of claim 16, further comprising a positioning and stabilizing frame separably connected to the seal-forming structure, the frame including a pair of upper arms, a pair of lower arms, and the male engagement structure.

18. A headgear connector, comprising: a retainer including a male engagement structure and configured to be connected to a patient interface; and a clasp including a female engagement structure and configured to be connected to a strap of the patient interface, wherein the female engagement structure includes a receptacle defining an opening, the receptacle having a first receptacle surface, a second receptacle surface, and a receptacle transition between the first receptacle surface and the second receptacle surface. wherein the male engagement structure includes a stem and a plurality of deflectable posts encircling the stem, each of the plurality of posts having a ridge protruding outward on a side facing away from the stem, and wherein the outwardly protruding ridges of the plurality of posts encircling the stem form an imaginary circle having a diameter greater than a diameter of the opening at the receptacle transition.

19. The headgear connector of claim 18, wherein the opening of the receptacle extends through opposing surfaces of the clasp.

20. The headgear connector of claim 18 or 19, wherein the male engagement structure comprises two, three, or four deflectable prongs.

21. A patient interface comprising: a headgear comprising a first strap and a second strap; a seal-forming structure; and a pair of headgear connectors according to any one of claims 18 to 20, the clasp being configured to connect to at least one of the first strap or the second strap.

22. The patient interface of claim 21, further comprising a positioning and stabilising frame separably connectable to the seal-forming structure, the frame comprising the male engagement structure. ​

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