Catheter for positioning and stabilizing structure and connector thereof

Abstract

A patient interface includes a positioning and stabilizing structure having a gas delivery tube for flow of pressurized air from a connection port to a seal-forming structure surrounding an airway of a patient. The gas delivery tube is wrapped by a textile material secured to an end of the tube by a portion of a structure that is also used to fluidly connect the tube with the seal forming structure and / or the connection port.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to Australian Patent Application No. 2023910, filed on 31 March 2023, and Australian Patent Application No. 2024900836, filed on 27 March 2024, 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] 2.2.2 Treatment

[0011] Various respiratory therapies, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow tamponade (HFT), have been used to treat one or more of the aforementioned respiratory disorders.

[0012] 2.2.2.1 Respiratory pressure therapy

[0013] 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).

[0014] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). Its mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway obstruction, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP therapy can be voluntary, and therefore patients may choose not to adhere to the therapy if they find the device used to provide such therapy to be uncomfortable, difficult to use, expensive, or unsightly.

[0015] 2.2.3 Respiratory Therapy System

[0016] 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.

[0017] 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.

[0018] 2.2.3.1 Patient Interface

[0019] Patient interfaces can be used to attach breathing equipment to their 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.

[0020] 2.2.3.1.1 Sealing Formation Structure

[0021] 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.

[0022] The patient interface can be partially characterized based on the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils during use. This single element may be designed, for example, to cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0023] 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.

[0024] 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.

[0025] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface and the seal-forming structure engages with the patient's face. The seal-forming structure may include an air- or fluid-filled pad, 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.

[0026] 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.

[0027] Another type of seal-forming structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0028] A series of patient interface sealing structure technologies are disclosed in the following patent applications: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0029] 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.

[0030] ResMed Inc. has manufactured the following products that incorporate a nose pillow: 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).

[0031] 2.2.3.1.2 Positioning and Stabilizing Structure

[0032] A sealing structure for a patient interface used in positive air pressure therapy is subjected to counter-stress from air pressure that threatens to break 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 patient interface use; how comfortable the interface is for the patient; whether the patient experiences invasiveness and / or claustrophobia while wearing the patient interface; and aesthetic appeal.

[0033] 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.

[0034] 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.

[0035] To improve patient compliance, positioning and stabilizing structures should be comfortable, easily adjustable, and readily identifiable for disconnection and / or detachment. Areas in contact with the patient's skin should not be hard or potentially scratch or otherwise irritate the skin.

[0036] 2.2.3.1.3 Pressurized air duct

[0037] 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.

[0038] 2.2.3.1.4 Pressurized air ducts used for positioning / stabilizing the sealing structure

[0039] Another type of 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 the 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 tubing." 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.

[0040] The goal is to combine a patient interface with a head sleeve that allows patients to wear it comfortably for extended periods while asleep, creating an airtight and stable seal with the patient's face, while also accommodating a range of patient head shapes and sizes.

[0041] To improve patient compliance, the hood cannula may consist of one or more tubes made of silicone or similar materials, which are covered with textiles to provide comfort and minimize skin irritation.

[0042] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0043] 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.

[0044] 2.2.3.3 Air Circuit

[0045] 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.

[0046] 2.2.3.4 Humidifier

[0047] 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.

[0048] 2.2.3.5 Data Management

[0049] 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.

[0050] The patient's treatment may benefit from other aspects of communicating treatment data to third parties or external systems.

[0051] 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.

[0052] 2.2.3.6 Ventilation technology

[0053] 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.

[0054] 2.2.4 Screening, Diagnosis and Monitoring System

[0055] 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.

[0056] 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.

[0057] 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

[0058] 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.

[0059] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0060] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0061] One aspect of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0062] 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.

[0063] One form of this technology includes a patient interface comprising an inflation chamber, a sealing formation structure, and a positioning and stabilizing structure.

[0064] One form of this technology includes a patient interface comprising an inflatable chamber pressurizable to a treatment pressure at least 4 cmH2O 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 configured 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 configured 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.

[0065] Another aspect of this technology is a series of modular elements that can be interconnected to form different styles of patient interfaces.

[0066] 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.

[0067] Another aspect of this technology includes a positioning and stabilizing structure for providing force to hold the sealing-forming structure in a therapeutically effective position on the patient's head. The sealing-forming structure is configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway, to seal and deliver an airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use. The positioning and stabilizing structure includes:

[0068] At least one gas delivery tube for receiving airflow from a connection port located on the top of the patient's head and a lower end configured to deliver the airflow to the inlet of the patient's airway via a sealing structure, the at least one gas delivery tube being configured and arranged to contact at least one region of the patient's head above an auricular base point during use, the at least one gas delivery tube comprising:

[0069] An inner tube includes a tube wall defining a hollow interior that forms a flow path for air to flow from the connection port to the sealing structure, and wherein the inner tube is configured with an upper end and a lower end.

[0070] An outer textile sleeve having an upper end and a lower end; and

[0071] A conduit connection structure is disposed at at least one of the upper end and the lower end of the inner tube, wherein the conduit connection structure is configured to connect the inner tube to either a connection port or a sealing structure, wherein the conduit connection structure is configured with a first surface that forms part of a flow path through the hollow interior of the inner tube, and wherein the conduit connection structure is configured with a second surface that is away from the flow path through the hollow interior of the inner tube and forms at least a part of an attachment region;

[0072] The attachment area is configured to receive at least one of the upper and lower ends of the outer textile sleeve.

[0073] Another aspect of this technology includes a gas delivery tube for positioning and stabilizing a structure, wherein the positioning and stabilizing structure is configured with: a connection port located on the top of a patient's head; and a sealing structure configured and arranged to seal with an area of ​​the patient's face surrounding the entrance to the patient's airway, to deliver an airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use, wherein the gas delivery tube is configured to receive the airflow from the connection port to the sealing structure, the gas delivery tube comprising:

[0074] An inner tube includes a tube wall defining a hollow interior that forms a flow path for air to flow from the connection port to the sealing structure, and wherein the inner tube is configured with an upper end and a lower end.

[0075] An outer textile sleeve having an upper end and a lower end; and

[0076] A conduit connection structure is disposed at at least one of the upper end and the lower end of the inner tube, wherein the conduit connection structure is configured to connect the inner tube to either a connection port or a sealing structure, wherein the conduit connection structure is configured with a first surface that forms part of a flow path through the hollow interior of the inner tube, and wherein the conduit connection structure is configured with a second surface that is away from the flow path through the hollow interior of the inner tube and forms at least a part of an attachment region;

[0077] The attachment area is configured to receive at least one of the upper and lower ends of the outer textile sleeve.

[0078] In the example, the conduit connection structure includes an engagement portion configured to engage with a complementary engagement portion disposed in one of the connection port or sealing formation structure.

[0079] In the example, the conduit connection structure includes a first loop disposed at one of the lower and upper ends of the inner tube.

[0080] In the example, the first ring includes an inner side and an outer side, the inner side having a first contact surface and a second contact surface.

[0081] In the example, the first contact surface of the first collar is substantially perpendicular to the second contact surface of the first collar.

[0082] In the example, the first contact surface contacts the opening of the inner tube, and the second contact surface contacts the inner surface of the hollow interior of the inner tube.

[0083] In the example, the attachment area is part of the second contact surface.

[0084] In the example, the attachment area is smaller than the length of the second contact surface.

[0085] In the example, the end of the second contact surface includes a ridge or protrusion.

[0086] In the example, the inner surface of the hollow interior of the inner tube includes ridges or protrusions for abutting against ridges or protrusions at the end of the second contact surface.

[0087] In the example, the lower end of the textile sleeve is fixed to the attachment area by adhesive or otherwise bonded.

[0088] In the example, the lower end of the textile sleeve is secured or otherwise bonded to the attachment area by molding the first loop over one of the lower or upper ends of the inner tube.

[0089] In the example, the lower end of the textile sleeve is secured or otherwise bonded to the attachment area by molding a second collar over one of the lower or upper ends of the inner tube.

[0090] In the example, at least a portion of the outer side of the first ring is the first surface that forms at least a portion of the flow path through the hollow interior of the inner tube.

[0091] In the example, at least a portion of the first surface includes an engagement portion configured to engage with a complementary engagement portion disposed in one of the connection port or sealing formation.

[0092] In the example, the first ring includes an end cap.

[0093] In the example, the end cap is attached to the first collar on the surface opposite the first contact surface of the first collar.

[0094] In the example, the attachment area is the joint between the end cap and the first collar.

[0095] In the example, the end cap is integrally formed with the first ring.

[0096] In the example, the engagement between the end cap and the first collar is a groove or recess.

[0097] In the example, the lower end of the textile sleeve is fixed to the attachment area by adhesive or otherwise bonded.

[0098] In the example, the lower end of the textile sleeve is secured or otherwise bonded to the attachment area by molding the end cap over the first collar.

[0099] In the example, the conduit connection structure is located at both the lower and upper ends of the inner tube.

[0100] In the example, the conduit connection structure is composed of one or more plastic materials, such as polycarbonate (PCB), polypropylene (PPE), nylon, or mixtures thereof.

[0101] In the example, the inner tube is composed of an elastomer.

[0102] In the example, the elastomer is composed of silicone resin, thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU), or another elastomer material or a mixture thereof.

[0103] In the example, the outer textile sleeve is made of a heat-fusible material.

[0104] In the example, the heat-melting material is yarn.

[0105] In the example, one of the lower and upper ends of the textile sleeve is heat-treated to form a flange.

[0106] In the example, the flange is received by the attachment area of ​​the conduit connection structure.

[0107] In the example, both the lower and upper ends of the textile sleeve are heat-treated to form flanges.

[0108] 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.

[0109] One aspect of this technology is a method for manufacturing equipment.

[0110] Another aspect of this technology is a method for assembling a modular system, the method comprising: selecting a positioning and stabilizing structure; and connecting the positioning and stabilizing structure to a first liner or a second liner.

[0111] 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.

[0112] One aspect of this technology is a portable RPT device that can be carried by a person (e.g., in that person's home).

[0113] 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.

[0114] The described methods, systems, apparatuses, 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, apparatuses, and devices can provide improvements in the field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0115] 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.

[0116] Other features of the present technology will become apparent from the following detailed description, summary of the specification, drawings and claims. Attached Figure Description

[0117] The technology is illustrated in the accompanying drawings by way of example and not limitation, wherein similar reference numerals refer to similar elements, including:

[0118] 4.1 Breathing Therapy System

[0119] 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.

[0120] 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.

[0121] 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.

[0122] 4.2 Respiratory System and Facial Anatomy

[0123] 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.

[0124] 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.

[0125] 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 mouth. It also indicates the directions of up, down, radially inward, and radially outward.

[0126] 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.

[0127] 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.

[0128] 4.3 Patient Interface

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

[0130] Figure 4A A patient interface with a catheter tip cap, according to this technology, is shown.

[0131] Figure 4A-1 The force acting on the patient interface in Figure 4 during use is shown.

[0132] Figure 4B A patient interface with a catheter tip cap, according to this technology, is shown.

[0133] Figure 5A A partial cross-sectional view of the lower end of the catheter and the inflation chamber of a first form of catheter head cover according to the present technology is shown before connection.

[0134] Figure 5B It shows Figure 5A A partial cross-sectional view of the lower end of the catheter and the inflation chamber after connection for the catheter head cap.

[0135] Figure 6A A side view of the end of the textile sleeve of a catheter for a catheter head cover, according to a second form of the present technology, is shown.

[0136] Figure 6B It shows Figure 6A A schematic diagram of the manufacturing process of the end of the textile sleeve.

[0137] Figure 6C It shows including Figure 6A A partial cross-sectional view of the lower end of a catheter used as a catheter head sleeve in a textile sleeve.

[0138] Figure 7 A partial cross-sectional view of the lower end of a catheter for a catheter head cover according to the third form of the present technology is shown.

[0139] Figure 8 A partial cross-sectional view of the lower end of a catheter for a catheter head cover according to the fourth form of the present technology is shown.

[0140] Figure 9 A partial cross-sectional view of the lower end of a catheter for a catheter head cover according to the fifth form of the present technology is shown.

[0141] Figure 10 A partial cross-sectional view of the lower end of a catheter for a catheter head cover according to the sixth form of the present technology is shown.

[0142] Figure 11 A partial cross-sectional view of the lower end of a catheter for a catheter head cover according to the sixth form of the present technology is shown.

[0143] Figure 12A A partial cross-sectional view of the lower end of a catheter for a catheter head cover according to the seventh form of the present technology is shown.

[0144] Figure 12B It shows Figure 12A Another partial cross-sectional view of the lower end of the catheter. Detailed Implementation

[0145] 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 discussed herein and is not intended to be limiting.

[0146] 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.

[0147] 5.1 Therapy

[0148] 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.

[0149] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0150] In some examples of this technology, mouth breathing is restricted, constrained, or prevented.

[0151] 5.2 Respiratory Therapy System

[0152] 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 or 3800.

[0153] 5.3 Patient Interface

[0154] According to one aspect of this technology, such as Figure 3 The noninvasive patient interface 3000 shown in Figure A 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 3600 for connecting to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the 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.

[0155] like Figure 4AAs shown, a non-invasive patient interface 3000 according to another aspect of the present technology includes the following functional aspects: a sealing forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, and a connection for connecting to an air circuit (such as...). Figures 1A to 1C The air circuit 4170 shown is a connection port 3600 in one form. The air chamber 3200 may be formed by one or more modular components (e.g., a gasket module 3150 together with a sealing forming structure 3100), in which case it or they may be replaced by different components, such as components of different sizes.

[0156] 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.

[0157] 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 cm H2O relative to the environment.

[0158] 5.3.1 Sealing Formation Structure

[0159] 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.

[0160] In one embodiment, the target sealing area is located on the outer surface of the sealing structure 3100.

[0161] In some forms of this technology, the sealing structure 3100 is constructed from a biocompatible material (e.g., silicone rubber).

[0162] The sealing structure 3100 according to this technology can be constructed from a soft, flexible, elastic material (such as silicone).

[0163] 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.

[0164] 5.3.1.1 Sealing Mechanism

[0165] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, this sealing flange readily responds to a system positive pressure acting on its underside within the inflation chamber 3200, thereby promoting a tight seal with the face. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0166] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends at least a portion of the path around the periphery. The support flange is a spring-like element or includes a spring-like element and serves to support the sealing flange and prevent it from bending during use.

[0167] In one form, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and arranged in a compressed state, for example, as a result of elastic tension in the positioning and stabilizing structure.

[0168] In one form, the sealing structure includes a tensioning portion. During use, this tensioning portion is held taut, for example, by a region adjacent to the sealing flange.

[0169] In one form, the sealing structure includes an area having an adhesive or bonding surface.

[0170] In some forms of this technology, the sealing structure may include one or more of the following: a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having an adhesive or bonding surface.

[0171] 5.3.1.2 Nasal bridge or nasal ridge area

[0172] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the bridge or ridge of the nose of the patient's face during use.

[0173] In one form, the sealing structure includes a saddle-shaped region configured to form a seal on the bridge or ridge of the nose of a patient's face during use.

[0174] 5.3.1.3 Upper lip area

[0175] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the upper lip region (i.e., the upper part of the lip) of the patient's face during use.

[0176] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip region of a patient's face during use.

[0177] 5.3.1.4 Chin area

[0178] In one embodiment, the non-invasive patient interface 3000 includes a sealing structure that forms a seal on the chin area of ​​the patient's face during use.

[0179] In one form, the sealing structure includes a saddle-shaped region configured to form a seal on the chin area of ​​a patient's face during use.

[0180] 5.3.1.5 Forehead area

[0181] In one form, the sealing structure forms a seal on the forehead area of ​​the patient's face during use. In this form, the inflatable chamber can cover the eyes during use.

[0182] 5.3.1.6 Nasal pillow

[0183] 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.

[0184] 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.

[0185] 5.3.1.7 Pure Nasal Mask

[0186] 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.

[0187] 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.

[0188] Another form of the 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." In one form, for example, as... Figure 4A As shown, the sealing structure 3100 is configured to form a seal with the lower surface of the nose surrounding the nostrils during use. The sealing structure 3100 can be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including sealing the lower and / or anterior surfaces of the nasal protuberance region of the patient's nose and sealing the patient's nasal alae. The sealing structure 3100 can form a seal with the patient's upper lip. The shape of the sealing structure 3100 can be configured to match or closely fit the lower side of the patient's nose and may not contact the nasal bridge region of the patient's nose or any portion of the patient's nose above the nasal protuberance. In one form of the nasal pad, the sealing structure 3100 includes a bridging portion that divides the opening into two orifices, each of which, during use, supplies air or breathable gas to the corresponding nostril in the patient's nasal cavity. The bridging portion can be configured to contact or abut against the patient's columella for a seal during use. Alternatively, the sealing structure 3100 may include a single opening to provide an air or breathable gas flow to both of the patient's nostrils.

[0189] In some forms, a nasal mask may include the nasal pillow described above.

[0190] 5.3.1.8 Nose and mouth mask

[0191] 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.

[0192] 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 1C The 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".

[0193] 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.

[0194] 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.

[0195] 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.

[0196] 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.

[0197] 5.3.2 Inflation Chamber

[0198] The air chamber 3200 has a periphery whose shape is designed to complement the surface contour of the area on a normal person's face that will form a seal during use. During use, the boundary edges of the air chamber 3200 are 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 can 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.

[0199] 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.

[0200] 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.

[0201] 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.

[0202] 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.

[0203] 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.

[0204] 5.3.3 Positioning and Stabilization Structure

[0205] 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 can be found in... Figure 3 A and Figure 4A As shown in the figure. For example, an example of the forces applied to the positioning and stabilizing structure in Figure 4 can be found in... Figure 4A-1 As shown in the image.

[0206] In one configuration, the positioning and stabilizing structure 3300 provides a holding force (i.e., F) sufficient to overcome the positive pressure in the inflation chamber 3200 to lift the face away from the air. 充气 ).

[0207] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the gravitational effects on the patient interface 3000.

[0208] 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.

[0209] 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.

[0210] 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 down in a supine sleeping position, wherein the back area of ​​the patient's head is on a pillow.

[0211] 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.

[0212] 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 strap. 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 disrupting the seal.

[0213] 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 for engagement with a hook material portion.

[0214] 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.

[0215] In one form of the technology, the positioning and stabilizing structure includes a first frenulum, which is configured and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the supraaural base of the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0216] In one form of the technology applicable to nasal masks or full-face masks, the positioning and stabilizing structure includes a second strap that is configured and arranged such that, in use, at least a portion of the upper edge of the second strap passes below the subauricular base of the patient's head and covers or is located below the occipital bone of the patient's head.

[0217] In one form of this technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap that is configured and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.

[0218] 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 when they are sleeping.

[0219] 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.

[0220] 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.

[0221] 5.3.3.1 Catheter head cover

[0222] 5.3.3.1.1 Catheter head sheath

[0223] In some forms of this technology, the positioning and stabilizing structure 3300 includes one or more head tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example, through the inflation chamber 3200 and the sealing formation 3100. In the form of this technology illustrated in FIG4, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver 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., the nose and / or mouth) during use. This allows the conduit providing the pressurized airflow from the air circuit 4170 to connect to a connection port 3600 of the patient interface, located in a position other than the front of the patient's face, for example, at the top of the patient's head.

[0224] exist Figure 4AIn the illustrated form of this technology, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 being positioned on a different side of the patient's head during use, and extending across the corresponding cheek area above the respective ear (above the supraacus base point of the patient's head) to a curved tube 3610 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.

[0225] 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 3310 forms part of the positioning and stabilizing structure 3300 and 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 3310 may each be under tension during use to help hold the sealing structure 3100 in a sealed position.

[0226] In one embodiment, the tube 3350 may be at least partially extendable, such that the tube 3350 and the strap 3310 can be adjusted to substantially equal lengths when worn by a patient. This allows for substantially symmetrical adjustment between the tube 3350 and the strap 3310, such that the sealing structure remains substantially centered.

[0227] exist Figure 4A In the illustrated embodiment, two tubes 3350 are fluidly connected to each other at their upper ends and to the connection port 3600. In some examples, the two tubes 3350 are formed integrally, 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 may have two arms / branches, each of which can be fluidly connected to a corresponding tube among the tubes 3350. Additionally, the T-connector may have a third arm or opening that provides the connection port 3600 for fluid connection to the air circuit 4170 in use.

[0228] In some forms, the third arm of a T-connector can be substantially perpendicular to each of the first two arms.

[0229] In some forms, the third arm of a T-connector can be formed at an angle relative to each of the first two arms.

[0230] 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.

[0231] 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.

[0232] 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.

[0233] Tube 3350 may be formed of a flexible material, such as an elastomer, like silicone, thermoplastic elastomer (TPE), or thermoplastic polyurethane (TPU), and / or one or more textiles and / or foam materials. 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 not applied. The shape of 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.

[0234] 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.

[0235] Each tube 3350 may be configured to receive an airflow from a connection port 3600 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 4AIn the example shown, each tube 3350 is located in use along a path extending from the inflation chamber 3200 across the patient's cheek region and above the patient's ear to the bend 3610. For example, the portion of each tube 3350 near the inflation 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 3610 may be located on the patient's parietal bone, frontal bone, and / or the junction between them (e.g., the coronal suture) in use.

[0236] In some forms of this technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned within 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 3600) to move relative to the lower portion of the patient interface 3000 (e.g., the inflation chamber 3200). That is, the connection port 3600 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 3600 on the patient's head (at least within a predetermined range).

[0237] 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 rear-upward (e.g., postero-superior) sealing force. 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.

[0238] Catheters forming part of the positioning and stabilizing structure 3300, such as headbands, can provide forces that aid in positioning and stabilizing the FPSS. For example... Figure 4A-1As illustrated, the positioning and stabilizing force FPSS can be the resultant force of various forces from different elements of the positioning and stabilizing structure 3300. For example, each catheter can provide a force F catheter guided in a posterior and corresponding lateral direction to hold the sealing forming structure 3100 against the patient's face (entering the upper lip and sealing below the nose) and to counteract the positive pressure in the inflation chamber 3200 to lift away from the face (i.e., F inflation). The force F catheter can also be guided at least partially in an upward direction to overcome gravity Fg.

[0239] 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.

[0240] 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.

[0241] Refer again Figure 4A-1 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 air chamber 3200 downwards, the frictional 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).

[0242] In some forms, the sum of the various forces can be equal to zero, so that the patient interface 3000 is in equilibrium (e.g., does not move along the patient's face during use). Specifically, gravity Fg and the blowing force Ff tend to move the seal-forming structure 3100 away from the desired sealing position. A positioning and stabilizing force FPSS is applied to counteract gravity Fg and the blowing force Ff (as well as any frictional force Ff) and keep the seal-forming structure 3100 properly positioned. While the positioning and stabilizing force FPSS may exceed the sum of gravity Fg and the blowing force Ff (where any additional positioning and stabilizing force FPSS is balanced by the reaction forces from the patient's head acting on the various parts of the patient interface 3000) and still maintain the seal-forming structure 3100 in the proper sealing position, patient comfort may be sacrificed. Maximum patient comfort can be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilizing force FPSS is just strong enough to achieve this. In some examples, the positioning and stabilizing structure 3300 can be adjustable such that, upon assembly, the positioning and stabilizing force FPSS is greater than the force required to precisely balance the gravity Fg and the inflation force F to hold the patient interface 3000 sufficiently close against the patient's head so that destructive forces that may be experienced during use (such as tube resistance or lateral shunting of the inflation chamber 3200 during lateral decubitus position) do not break the seal. As described below, various positions of the patient's head when using the patient interface 3000 can determine the positioning and stabilizing force FPSS required to achieve balance.

[0243] 5.3.3.1.2 Extendable and non-extendable pipe sections

[0244] 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 4A The patient interface 3000 shown includes a tube 3350, the upper part of which includes extendable tube segments, each extendable tube segment being in the form of an extendable accordion structure 3362.

[0245] In some forms, the extendable accordion-like structure 3362 can be formed as a series of ridges and grooves on the surface of the tube 3350. The accordion-like structure 3362 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 segment 3363), the accordion-like structure 3362 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, as a result of the accordion-like structure 3362, 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 3362 can be slightly adjusted to fit an individual patient.

[0246] 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.

[0247] In some examples of this technology, the non-extendable tube segment 3363 connects to the inflation chamber 3200 at a low angle. The headgear tube 3350 may extend downward to the side of the patient's head and then bend forward and inward 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 in at least a partially upward direction 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 patient's cheekbone, which may be more comfortable than contacting the patient's cheekbone and may avoid excessively obscuring the patient's peripheral vision.

[0248] 5.3.3.1.3 Catheter head connection port

[0249] In some forms of this technology, the patient interface 3000 may include a connection port 3600 located near the upper, outer, or rear portion of the patient's head. For example, in Figure 4AIn the illustrated form of the present technology, the connection port 3600 is located at the top of the patient's head (e.g., in an overhead position relative to the patient's head). In this example, the patient interface 3000 includes a bend 3610 forming the connection port 3600. The bend 3610 may be configured to be in fluid connection with a conduit of the air circuit 4170. The bend 3610 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 3610 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 3350 via a ball-and-socket joint. The connection portion 3600 may be located in the sagittal plane of the patient's head during use.

[0250] Patient interfaces with a connection port not located in front of the patient's face may be advantageous, as 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).

[0251] 5.3.3.1.4 Fluid Connection of Head Sleeve

[0252] Two tubes 3350 are fluidly connected at their lower ends to the inflation chamber 3200 and at their upper ends to the connection port 3600. In some forms of this technology, the connection between the tubes 3350 and the inflation chamber 3200 and / or the connection port 3600 is achieved through a conduit connection structure 3500.

[0253] The catheter connection structure 3500 can be configured to allow the patient to reliably and easily connect the tube 3350 to the inflation chamber 3200 and / or the connection port 3600. The tube 3350 and the inflation chamber 3200 and / or the connection port 3600 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. In one form, the tube 3350 is formed of silicone, TPE, or TPU, textile material, or mixtures thereof, and the lower end 3350A of each tube 3350 is overmolded to a connector 3502 made of, for example, polypropylene, polycarbonate, nylon, etc.

[0254] The conduit connection structure 3500 on each tube 3350 may include a concave mating feature 3502 configured to connect with a convex mating feature 3504 disposed on the inflation chamber 3200 and / or the connection port 3600. Alternatively, the conduit connection structure 3500 on each tube 3350 may include a convex mating feature configured to connect to the concave mating feature on the inflation chamber 3200 and / or the connection port 3600. In other examples, each tube 3350 may each include a convex connector or a concave connector formed of a flexible material (such as silicone, TPE, or TPU, for example, the same material forming the tube 3350).

[0255] In other examples, the conduit connection structure 3500 may be in the form of a compression seal for connecting each tube 3350 to the inflation chamber 3200 and / or connection port 3600. For example, a resilient flexible (e.g., silicone) tube 3350 may be configured to be compressed to reduce its diameter, allowing it to be compressed into the port in the inflation chamber 3200, and the inherent resilience 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 may be pushed against the junction between the tube 3350 and the circumferential surface around the port or connector in the inflation chamber 3200 to form or reinforce the seal between the tube 3350 and the inflation chamber 3200.

[0256] As previously discussed, catheter 3350 can be formed from flexible materials, such as elastomers like silicone, TPE, TPU, or other elastomers. For patient comfort, catheter 3350 can be covered with textiles. In some examples, this can be achieved using a separate textile that is configured as a tubular sleeve of a suitable material (such as nylon, polyester, spandex, or mixtures thereof). This separate textile sleeve can be simply slipped over catheter 3350 as needed. In other examples, the textile can be provided in sheet form, which can be wrapped around catheter 3350 and secured in place with hook and loop materials, etc.

[0257] In other examples, such as Figure 4B The patient interface shown allows the lower end of the textile sleeve 3351 to be integrated with the catheter 3350 using a catheter connection structure 3500 to form a seamless finish at its lower end (as shown). The upper end of the textile sleeve 3351 can be integrated with a connector located at the upper (out-of-visibility) end of the catheter 3350. This provides a more aesthetically pleasing appearance for catheters constructed in this manner compared to catheters with a removable textile sleeve, as described above.

[0258] Figure 5A and Figure 5B A partial cross-sectional view of the lower end 3350A of the catheter 3350 and the inflation chamber 3200 is shown, showing the catheter 3350 before it is connected to the inflation chamber 3200. Figure 5A ) and after connection ( Figure 5B The conduit connection structure is 3500.

[0259] The conduit connection structure 3500 is composed of a suitable rigid plastic material (e.g., polycarbonate (PCB), polypropylene (PPE), nylon, or mixtures thereof) and is essentially in the form of a collar or snap ring surrounding the periphery of the end of the conduit 3350. In this example, the conduit connection structure 3500 is provided with an engagement portion in the form of a concave mating feature or connector 3502, which is configured to connect with a complementary engagement portion in the form of a convex mating feature or connector 3504 disposed in the inflation chamber 3200. It should be understood that the connector 3504 may form part of the inlet port of the inflation chamber 3200. As shown, the corresponding concave mating features 3502 and convex mating features 3504 may also surround the periphery of the conduit 3350, but may alternatively be configured as different pins or similar protrusions, equidistantly arranged around the collar.

[0260] As can be seen from the cross-sectional view, the conduit 3350 is formed of an inner tube 3353 or a layer of suitable elastomeric material (such as silicone, TPE, TPU, or another suitable elastomer), upon which a textile sleeve 3351 is applied. The lower end 3351A of the textile sleeve is folded over the opening 3354 of the inner tube 3353 and contacts the inner surface near the opening of the inner tube. An airflow path is formed inside the inner tube through the conduit 3350.

[0261] To prevent the end 3351A of the textile sleeve 3351 from entering the air path through the conduit 3350, the connector 3502 is configured to form an L-shaped profile having a first arm 3502A defined by a vertical portion of the connector and a second arm 3502B defined by a flange extending horizontally from the vertical portion. In this example, the inner surface of the L-shaped profile provides a contact surface that contacts the orifice and inner surface of the inner tube. In use, the connector has an attachment area for receiving the lower end 3351A of the textile sleeve and securing it between itself (the connector) and the inner tube. The outer surface of the second arm 3502B (i.e., the surface facing the interior of the inner tube 3353) is configured with a groove 3502C or similar structure that receives a complementary ridge 3504A or protrusion or similar structure of the connector 3504 disposed in the air chamber 3200. In this example, the outer surface of the first arm 3502A abuts against and contacts the vertical portion of the connector 3504 of the inflation chamber 3200.

[0262] like Figure 5B As clearly shown, the contact surface of the first arm 3502A abuts against the opening 3354 of the inner tube 3353, while the contact surface of the second arm 3502B (whose length is intentionally greater than the folded end 3351A of the textile sleeve 3351) abuts against the inner surface of the inner tube. This clamps the end 3351A of the textile sleeve 3351, preventing it from extending into the air path through the inner tube 3353. The opening of the inner tube may be constructed with a small groove or similar structure to better receive the folded end 3351A of the textile sleeve.

[0263] As described above, a portion of the outer surface of connector 3502 forms part of the air path through conduit 3350. (Back to Reference) Figure 4B From the outside, when the conduit 3350 is connected to the inflation chamber 3200, only the end of the first arm 3502A of the connector of the conduit connection structure 3500 is visible, and it can be seen that this makes the joint between the connector 3502 and the textile sleeve 3351 present a smooth and flat transition effect.

[0264] During the manufacture and / or assembly of the conduit 3350, a suitable adhesive or bonding agent may be applied to the attachment area defined by the inner surfaces of the first arm 3502A and the second arm 3502B of the connector 3500 and / or the port 3354 of the inner tube 3353 and / or the end of the textile sleeve 3351. In the example shown, the adhesive is applied such that only the portion of the textile sleeve 3351 near the port 3354 of the inner tube 3353 and the portion at that port are secured. This allows the majority of the remaining portion of the textile sleeve to move to some extent relative to the inner tube below. This can provide some useful cushioning in the event that the conduit 3350 is being dragged onto a bed or similar fixture. In another example, the conduit connection structure 3500 and / or the connector 3502 may be overmolded onto the port of the inner tube, thereby clamping the end 3351A of the textile sleeve 3351.

[0265] Although only the lower end 3350A of the conduit 3350 is shown here, it should be understood that the conduit connection structure located at the upper end of the conduit can be constructed in a similar manner to secure the textile sleeve 3351.

[0266] Figures 6A to 6C Another example is depicted of securing a textile sleeve 3351 to an inner tube 3353 using the conduit connection structure 3500 of the present invention. This method allows the end 3351A of the textile sleeve 3351 to be positioned outside the air path of the conduit 3350. In this example, the textile sleeve 3351 is constructed with a relatively rigid flange 3351B at its end 3351A, such as... Figure 6A As shown. In this example, the material used to form the textile sleeve is essentially composed of heat-melting yarn or a mixture comprising heat-melting yarn. In some other examples, the textile sleeve may be composed of two or more types of materials; one type of material may be used for the body of the sleeve, and heat-melting yarn may be used for the ends of the sleeve.

[0267] like Figure 6B As shown, a textile sleeve 3351 with a flange 3351B can be constructed by fitting a textile sleeve onto a tubular clamp 3900. The cross-sectional dimensions of the clamp 3900 necessitate stretching the textile sleeve 3351 before it can be fitted onto it. By partially inserting the clamp 3900 into the textile sleeve 3351 (or by partially pulling the textile sleeve 3351 onto the clamp 3900), the end of the textile sleeve abuts against the upper surface 3900A of the clamp 3900. The clamp 3900 can then be heated to a sufficient temperature to melt the end of the sleeve, and as the end cools, a flange 3351B is formed around the edge of the clamp 3900.

[0268] Figure 6CThe catheter connection structure 3500 of the lower end 3350A of the catheter in assembled form is shown. In this example, the connector 3502 of the catheter connection structure 3500 is a collar, which is constructed with a substantially L-shaped cross-sectional profile, as shown in the figure. Figure 5A and Figure 5B As discussed in the embodiment, the inner side of the first arm 3502A is a contact surface that abuts against and contacts the orifice 3354 of the inner tube 3353, while the inner side of the second arm 3502B is a contact surface that abuts against the inner surface of the inner tube. The outer side of the second arm 3502B is provided with a groove 3502C for receiving a complementary feature (not shown in this view) of the connector disposed in the inflation chamber. In this example, the connector 3502 has been overmolded to the orifice 3354 of the inner tube 3353. The end cap 3506, in this example, is configured with an L-shaped profile, similar to the connector 3502, and is secured to the first arm 3502A of the connector 3502 using an adhesive or other bonding agent. This forms an attachment region 3508, which is in the form of a groove or recess extending circumferentially along the junction between the end cap 3506 and the conduit connection structure 3500. The groove 3508 receives the flange 3351B of the textile sleeve 3351 while being outside the airflow path through the inner tube 3353. The flange 3351B can be secured to the attachment area of ​​the conduit connection structure 3500 using adhesive.

[0269] Please note that in Figure 6C In this design, the conduit connection structure 3500 is actually constructed from two parts: the main portion of the connector 3502 and the end cap 3506. A groove 3508 for receiving the flange 3351B of the textile sleeve 3351 is formed at the joint between the corresponding end cap 3506 and the connector 3502. However, in some examples, the end cap 3506 can be integrated with the connector 3502, i.e., it can be formed as a single, integral component. This can provide a more rigid conduit connection structure 3500.

[0270] In some examples, Figure 6C The 3500 conduit connection structure can also be used with un-based Figure 6B The manufactured textile sleeve 3351 is used in conjunction. At this time, simply fold the end 3351A of the textile sleeve into the groove 3508 and fix it with an adhesive or another adhesive.

[0271] Turning Figure 7This figure illustrates another example of a conduit connection structure 3500 at the lower end 3350A of conduit 3350. Similar to the previously described example, the conduit connection structure 3500 has a connector 3502 configured with a first arm 3502A abutting the port 3354 of the inner tube 3353 and a second arm 3502B contacting the inner surface of the inner tube. A ridge 3510 is provided at the end of the second arm 3502B, which abuts in use against a complementary ridge 3355 disposed on the inner surface of the inner tube 3353. An attachment region 3508 is at least partially defined by the ridge and the first arm 3502A. During assembly, the lower end 3351A of the sleeve 3351 can be folded over the port 3354 of the inner tube 3353 and the connector 3502 inserted therein, and bonded to the attachment region using a suitable adhesive. The corresponding ridges 3510 and 3355 are used to ensure that the lower end 3351A of the sleeve does not extend into the airflow path through the duct 3350.

[0272] In some examples, a series of ridges may be provided on the inner surfaces of the second arm 3502B and the inner tube 3353; these ridges may provide a clamping effect, holding the end 3351A of the textile sleeve 3351 between them, while ensuring that the end 3351A does not enter the airflow path through the inner tube 3353.

[0273] Unlike the previously described example, the conduit connection structure 3500 has Figure 7 The connector 3502 is configured with a convex mating feature, which is received by a concave mating feature (not shown in this view) disposed in the inflation chamber. A groove 3512 is provided in the connector 3502 for receiving the concave mating feature (not shown). It should be understood that the principle of the conduit connection structure described herein applies regardless of whether the connector is configured with a convex or concave mating feature.

[0274] Figure 8 An alternative example of the catheter connection structure 3500 for catheter 3350 is shown. Similar to the previously described embodiments, the inner tube 3353 is formed of a suitable silicone resin, TPE, TPU, or other such elastomer. When assembling catheter 3350, the inner tube 3353 mates with the second arm 3502B of connector 3502, appropriately bonding the respective components together. As can be seen, the inner surface around the orifice 3354 of the inner tube 3353 is appropriately recessed to receive connector 3502. Connector 3502 is configured as an injection-molded part of a suitable biocompatible plastic material (such as polycarbonate, polyamide / nylon, or polybutylene terephthalate).

[0275] A textile sleeve 3351 is then installed to cover the inner tube 3353. In some cases, an adhesive coating is applied to the inner tube 3353 to help secure the textile sleeve along most of its length. The lower end 3351A of the textile sleeve 3351 may at least partially overlap with the second arm 3502B of the connector 3502. The region of the connector upstream of the first arm 3502A forms part of the attachment region 3508 of the connector 3502. This attachment region is located outside the air path flowing through the conduit 3350. For a clean finish, the lower end 3351A of the textile sleeve 3351 may be heat-treated using ultrasonic technology or welded to the attachment region; this also minimizes any loose fibers generated by the textile sleeve 3351.

[0276] Figure 9 The example of the catheter connection structure 3500 shown is constructed in accordance with the previous description. Figure 8 The description is similar. However, the way the lower end 3351A of the textile sleeve 3351 is fixed to the attachment area 3508 is different. For example, in Figure 9 As can be seen, the lower end 3351A of the textile sleeve 3351 can be secured in place relative to the attachment area 3508 of the connector 3502 by a clamp / ring 3503 that is covered with molded or applied thermoplastic elastomer material. This provides another way to achieve an aesthetic finish for the conduit 3350, while also providing a potentially more secure means of securing the lower end 3351A of the textile sleeve 3351. It should be understood that in some cases, even if the clamp / ring 3503 can still be applied afterwards, the lower end 3351 of the textile sleeve 3351A can preferably be ultrasonically welded or bonded to the attachment area 3508. In some cases, this approach can facilitate the use of thinner clamps / rings, thereby allowing for a smaller size of the connector 3502.

[0277] Another form of this technology is... Figure 10 As shown in the text, and in some respects with Figure 6CSimilarly, the portion of the conduit connection structure 3500 disposed in the conduit 3350 consists of two parts; the first part is a connector 3502, which is suitably configured to engage with an inflation chamber (not shown). As with the previously described embodiments, the connector 3502 can be formed as an injection-molded part made of a suitable thermoplastic material (such as polycarbonate, polyamide / nylon, or polybutylene terephthalate). The second part is a collar 3505 for bonding the connector 3502 to the inner tube 3353. The collar 3505 includes an attachment region 3508 for securing the lower end 3351A of the textile sleeve 3351. The collar 3505 can be formed of adhesive silicone. This arrangement can be useful, specifically in that the nozzle 3354 of the inner tube 3353 can be a simpler molded part, which facilitates improved manufacturing efficiency.

[0278] In one example Figure 10 The manufacturing steps of the conduit 3350 may include: forming an inner tube 3353, attaching a textile sleeve 3351, and subsequently applying a collar 3505. As an adhesive silicone injection molded part, the collar 3505 is bonded to the opening 3354 of the inner tube 3353, and also clamps and secures the lower end 3351A of the textile sleeve 3351 between it and the outer surface of the inner tube 3353. A connector 3502 can then be attached, also bonded to the collar 3505. During manufacturing, an excess of adhesive silicone can be applied to the conduit 3350 via a suitable molding technique (e.g., by adding an overflow groove to an inner core mold) to ensure complete bonding near the periphery of the opening 3354 of the inner tube 3353. This technique can also be used to ensure a substantially smooth finish or transition effect on the inner surfaces of the inner tube 3353 and the connector 3502 (defining the path of airflow). This can reduce potential defects that may accumulate harmful fungi, mold, bacteria, or general dirt.

[0279] Figure 11 Another form of the conduit connection structure 3500 is illustrated, with... Figure 10 Similar to the previous type, this conduit connection structure facilitates efficient molding of the inner tube 3353, particularly due to the simpler construction of the nozzle 3354. During the manufacture of this type of conduit 3350, the inner tube is molded first, and then the textile sleeve 3351 is fitted on top. It can be seen that the outer surface of the nozzle 3354 is concave relative to the rest of the inner tube. This allows the lower end 3351A of the textile sleeve 3351 to have a hanging portion. (And...) Figure 10Unlike other connectors, connector 3502 is a one-piece structure, including an attachment region 3508 at its upper (i.e., upstream) end. This connector is applied to the opening 3354 of the inner tube 3353 as an overlay molding layer, and the attachment region 3508 receives and secures the lower end 3351A of the textile sleeve 3351. During the manufacturing process, the application of connector 3502 may not occur immediately after the inner tube 3353 is formed and fitted onto the textile sleeve 3351; in some examples, the inner tube may be at least partially cured or otherwise shaped.

[0280] Although in some examples. Figure 11 The connector 3502 can be formed from the previously mentioned polycarbonate, polyamide / nylon, or polybutylene terephthalate materials, but in other examples, the connector can be molded from a silicone resin with a relatively high Shore hardness to provide adequate rigidity. In one non-limiting example, the hardness of the silicone resin used for connector 3502 can be selected between about 40 and 95 Shore A, or in another example, between about 10 and 80 Shore D.

[0281] Another form of the 3500 conduit connection structure is... Figure 12A and Figure 12B As shown in the diagram. Similar to the previously described example, the conduit 3350 is formed of an inner tube of silicone material, which is fitted with a textile sleeve 3351. However, in this particular example, an adhesive silicone overmolded layer 3507 is applied to the inner surfaces of the first arm 3502A and / or the second arm 3502B of the connector 3502 and / or the port 3354. Although in Figure 12A and Figure 12B In the diagram, the overlay molding layer 3507 is shown as part of the air path that clearly forms through the conduit 3350, but in some examples, this area of ​​the overlay molding layer 3507 may be squeezed between the connector 3502 and the opening 3354 of the inner tube, so that the area is not visible after the conduit 3350 is assembled.

[0282] In this form of the technology, the attachment region 3508 is formed by the outer surface of the connector 3502. This attachment region receives a molding overlay 3509 made of a suitable thermoplastic polyurethane or thermoplastic elastomer. Thus, the connector 3502 is essentially a two-part structure; the first part (connector 3502) has a clip structure 3511 constructed on its inner surface. This clip structure 3511 engages or otherwise joins with a complementary groove or structure (not shown) provided on a suitable surface of the inflation chamber. The second part is the molding overlay 3509, which secures the lower end 3351A of the textile sleeve 3351 to the attachment region 3508 (in some examples, the lower end 3351A may also be ultrasonically welded or otherwise bonded to the attachment region 3508). The molding overlay 3509 may also be configured to form part of a flanged seal together with the inflation chamber (not shown).

[0283] The advantage of this configuration is that the outer surfaces of the corresponding conduit 3350 and conduit connection structure 3500 are substantially continuous and smooth. Another advantage is that the textile sleeve 3351 can be added to the conduit after the inner tube 3353 and connector 3502 have been bonded together. This facilitates conduit assembly.

[0284] 5.3.3.2 Headgear straps

[0285] exist Figure 4A In the example shown, the strap 3310 of the positioning and stabilizing structure 3300 is connected between two tubes 3350, which are positioned on each side of the patient's head and wrap around the back of the patient's head, for example, covering or located below the occipital bone of the patient's head during use. The strap 3310 is connected to each tube above the patient's ear. Reference Figure 4A The positioning and stabilizing structure 3300 includes a pair of tabs 3320. In use, a strap 3310 can be attached 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.

[0286] In some forms, the strap 3310 may be at least partially forked, with a seam in the middle section to divide the strap 3310 into an upper and lower section. This allows for greater strap coverage over the back of the patient's head, which can help to better anchor the headgear to the patient's head, since there is no lower strap.

[0287] 5.3.4 Vent

[0288] In one embodiment, the patient interface 3000 includes a ventilation port 3400 that is configured and arranged to allow flushing of exhaled gases (e.g., carbon dioxide).

[0289] In some configurations, the airway 3400 is configured to allow continuous airflow from the interior of the inflation chamber 3200 to the environment, while the pressure within the inflation chamber is positive relative to the environment. The airway 3400 is constructed such that the airflow rate is sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining therapeutic pressure within the inflation chamber during use.

[0290] The vent 3400 can be located in the inflation chamber 3200, such as Figure 4A As shown. Alternatively, the vent 3400 may be located in a disconnected connection structure (e.g., a rotating shaft, such as a bend 3610).

[0291] 5.3.5 Disconnection from the connection structure

[0292] In one form, the patient interface 3000 includes at least one disengagement structure, such as a swivel or ball head and socket.

[0293] 5.3.6 Connection Port

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

[0295] 5.3.7 Forehead Support

[0296] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0297] 5.3.8 Anti-suffocation valve

[0298] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0299] Port 5.3.9

[0300] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In another embodiment, this allows direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0301] 5.4RPT device

[0302] An RPT device 4000 according to one aspect of the present technology includes mechanical components, pneumatic components, and / or electrical components, and is configured to perform one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 can 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.

[0303] 5.5 Air Circuit

[0304] According to one aspect of the art, the air circuit 4170 is a conduit or tube that is constructed and arranged to allow airflow to travel between two components (such as the RPT device 4000 and the patient interface 3000) during use.

[0305] 5.6 Glossary

[0306] 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.

[0307] 5.6.1 General Terminology

[0308] 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.

[0309] Environment: In some forms of this technology, the term environment will be considered to mean (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0310] 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 type of ambient humidity can differ from the humidity outside the patient's bedroom.

[0311] In another example, environmental stress can be stress that is either close to the body or outside the body.

[0312] 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.

[0313] 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.

[0314] 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 other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing when no indication of partial upper airway obstruction is detected.

[0315] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, referring to flow rate will refer to a scalar, that is, a quantity that only has magnitude. In other cases, referring to flow rate will refer to a vector, 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' or 'airflow'.

[0316] 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.

[0317] Flow therapy: This includes respiratory therapy that delivers a controlled flow of air to the inlet of the airway at a rate known as therapeutic flow, which is typically positive throughout the patient’s respiratory cycle.

[0318] Humidifier: The term humidifier will be considered to refer to a humidifying device that is constructed and arranged or configured with a physical structure to provide a therapeutically beneficial amount of water (H2O) vapor to an airflow to alleviate a patient’s medical respiratory symptoms.

[0319] 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.

[0320] 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.

[0321] Radiated noise (acoustic): In this document, radiated noise refers to noise transmitted to the patient by ambient air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object under discussion according to ISO 3744.

[0322] 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).

[0323] 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”.

[0324] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0325] Patient: A person, regardless of whether they have a respiratory illness.

[0326] 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 / m² = 1 millibar to 0.001 atmospheres). In this specification, unless otherwise stated, pressure is given in cmH₂O.

[0327] 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.

[0328] Respiratory pressure therapy: Applying an air supply to the airway entrance at a therapeutic pressure that is normally positive relative to the atmosphere.

[0329] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0330] 5.6.1.1 Materials and their properties

[0331] 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).

[0332] • "Soft" materials can include silicone resins or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0333] • "Hard" materials can include polycarbonate, polypropylene, and can be resistant to deformation, for example, under finger pressure.

[0334] Silicone or silicone elastomer: a synthetic rubber. In this specification, reference to silicone 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.

[0335] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0336] 5.6.1.2 Mechanics

[0337] axis:

[0338] a. Neutral axis: An axis in the cross-section of a beam or plate that has no longitudinal stress or strain.

[0339] b. Vertical axis: The axis that extends along the length of the shape. This axis usually passes through the center of the shape.

[0340] c. 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.

[0341] 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.

[0342] Elasticity: The ability of a material to return to its original geometry after deformation.

[0343] 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.

[0344] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0345] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain silicone resins and thermoplastic elastomers.

[0346] Rigid structures or components: Structures or components that will not substantially change shape when subjected to 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 pressure of approximately 20 to 30 cmH2O.

[0347] For example, an I-beam may have a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, a structure or component may be soft in the first direction and rigid in the second direction.

[0348] 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.

[0349] Viscosity: The ability of a material to resist flow.

[0350] Viscoelasticity: The ability of a material to exhibit both elastic and viscous behavior during deformation.

[0351] Yield: The condition where a material, after being deformed, no longer returns to its original geometry.

[0352] 5.6.1.3 Structural Components

[0353] Compression component: A structural element that resists compressive forces.

[0354] 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.

[0355] 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.

[0356] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0357] Lacing (noun): A structure designed to resist tension.

[0358] Thin structure:

[0359] d. Beam,

[0360] 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.

[0361] e. membrane,

[0362] 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).

[0363] f. Plates and shells

[0364] i. They can be relatively long in two directions and relatively thin in one dimension. They can have bending, tensile, and / or compressive stiffness.

[0365] Thick structure: solid

[0366] 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.

[0367] 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.

[0368] Reinforcement: Reinforcement is considered to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0369] Column: A column is considered a structural component designed to increase the compressive strength of another component in at least one direction.

[0370] 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, little or no airflow leaks from the rotary shaft.

[0371] 5.6.2 Anatomy

[0372] 5.6.2.1 Facial Anatomy

[0373] Alar: The outer wall or "wing" of each nostril (plural: alar).

[0374] Alar angle: The angle formed between the alar wings of each nostril.

[0375] Alar tip: the outermost point on the ala of the nose.

[0376] 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.

[0377] Auricle: The entire visible external part of the ear.

[0378] (Nose) Skeletal framework: The skeletal framework of the nose includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0379] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral septum, major cartilage, and minor cartilage.

[0380] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0381] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort horizontal plane that intersects the subnasal point.

[0382] Frankfurt plane: A line extending from the lowest point of the orbital rim to the left tragus point. The tragus point is the deepest point in the notch above the tragus of the auricle.

[0383] The glabella is located on the soft tissue, at the most prominent point in the sagittal plane of the forehead.

[0384] Lateral nasal cartilage: a cartilaginous plate that is basically triangular in shape. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0385] Lower lip (midpoint of the lower lip): The lip that extends between the point below the nose and the mouth.

[0386] Upper lip (midpoint of the upper lip): The lip that extends between the mouth and the supramental point.

[0387] 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.

[0388] Nostrils: Roughly oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostril is nasal septum (naris). Nostrils are separated by the nasal septum.

[0389] 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.

[0390] Nasolabial angle: The angle between the columella and the upper lip (which intersect at the subnasal point).

[0391] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0392] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0393] 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.

[0394] The philtrum is a midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0395] Prechin point: Located on the soft tissue, at the very front midpoint of the chin.

[0396] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the tip of the nose.

[0397] 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.

[0398] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0399] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0400] 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.

[0401] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the mid-sagittal plane.

[0402] 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.

[0403] Skull Anatomy

[0404] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0405] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the jaw that forms the chin.

[0406] 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.

[0407] 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 connection point.

[0408] 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.

[0409] Occipital bone: The occipital bone is located on the back and lower part of the skull. It includes the foramen magnum, an oval-shaped cavity through which the cranial cavity connects to the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0410] The eye socket is the bony cavity in the skull that houses the eyeball.

[0411] Parietal bone: The parietal bone is the skeleton that forms the top and sides of the skull when they are joined together.

[0412] 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.

[0413] Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the prominent parts of the cheeks.

[0414] 5.6.3 Patient Interface

[0415] 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.

[0416] 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.

[0417] 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. A shell may form part of the wall of the mask inflation chamber.

[0418] 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.

[0419] 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, clinically effective flushing can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute, depending on the mask design and treatment pressure.

[0420] 5.7 Other Notes

[0421] 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.

[0422] 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.

[0423] 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.

[0424] Furthermore, as used herein, “approximately,” “substantially,” “about,” or any similar terms mean + / - 5-10% of the stated values.

[0425] 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.

[0426] When a particular material is identified as being used to construct a component, obviously alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are to be understood as being capable of being manufactured, and therefore may be manufactured together or separately.

[0427] It must be noted that, unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” as used herein and in the appended claims include their plural equivalents.

[0428] All publications mentioned herein are incorporated herein by reference in their entirety 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.

[0429] The terms “comprises” and “comprising” should be understood as referring to each element, component or step in a non-exclusive manner, indicating that the referenced element, component or step may exist or be used, or may be combined with other elements, components or steps not expressly referenced.

[0430] The headings included in the detailed description are for the reader's convenience only and should not be used to limit the subject matter found throughout the disclosure or claims. These headings should not be used to interpret the claims or to limit their scope.

[0431] 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 rather 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 its aspects can be performed concurrently or even synchronously.

[0432] 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.

[0433] 5.8 List of reference numerals

[0434]

[0435]

Claims

1. A positioning and stabilizing structure for providing force to hold a sealing-forming structure in a therapeutically effective position on a patient's head, the sealing-forming structure being configured and arranged to form a seal with a region of the patient's face surrounding the entrance to the patient's airway to seal and deliver an airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use, the positioning and stabilizing structure comprising: At least one gas delivery tube for receiving airflow from a connection port located on the top of the patient's head and a lower end, the lower end being configured to deliver the airflow to the inlet of the patient's airway via the sealing structure, the at least one gas delivery tube being configured and arranged to contact at least one region of the patient's head above an auricular base point during use, the at least one gas delivery tube comprising: An inner tube includes a tube wall defining a hollow interior, the hollow interior forming a flow path for air to flow from the connection port to the sealing structure, and wherein the inner tube is configured with an upper end and a lower end. An outer textile sleeve, the outer textile sleeve having an upper end and a lower end; and A conduit connection structure is disposed at at least one of the upper and lower ends of the inner tube, wherein the conduit connection structure is configured to connect the inner tube to either a connection port or a sealing structure, wherein the conduit connection structure is configured with a first surface that forms part of a flow path through the hollow interior of the inner tube, and wherein the conduit connection structure is configured with a second surface that is away from the flow path through the hollow interior of the inner tube and forms at least a portion of an attachment region. The attachment region is configured to receive at least one of the upper and lower ends of the outer textile sleeve.

2. The positioning and stabilizing structure according to claim 1, wherein the conduit connection structure includes an engagement portion configured to engage with a complementary engagement portion disposed in one of the connection port or sealing formation structure.

3. The positioning and stabilizing structure according to claim 1 or claim 2, wherein the conduit connection structure includes a first collar, the first collar being disposed at one of the lower end and the upper end of the inner tube.

4. The positioning and stabilizing structure according to claim 3, wherein the first collar includes an inner side and an outer side, the inner side having a first contact surface and a second contact surface.

5. The positioning and stabilizing structure according to claim 4, wherein the first contact surface of the first collar is substantially perpendicular to the second contact surface of the first collar.

6. The positioning and stabilizing structure according to claim 4 or claim 5, wherein the first contact surface contacts the opening of the inner tube, and the second contact surface contacts the inner surface of the hollow interior of the inner tube.

7. The positioning and stabilizing structure according to claim 4 or claim 5, wherein one of the first contact surface and the second contact surface contacts a second collar disposed at the opening of the inner tube.

8. The positioning and stabilizing structure according to any one of claims 4 to 7, wherein the attachment region is formed by at least a portion of the second contact surface.

9. The positioning and stabilizing structure according to claim 7, wherein the attachment region is formed by at least a portion of the second collar.

10. The positioning and stabilizing structure according to any one of claims 4 to 9, wherein the attachment area is less than the length of the second contact surface.

11. The positioning and stabilizing structure according to any one of claims 4 to 10, wherein the end of the second contact surface includes a ridge or a protrusion.

12. The positioning and stabilizing structure according to any one of claims 4 to 11, wherein the inner surface of the hollow interior of the inner tube includes ridges or protrusions for abutting against ridges or protrusions at the end of the second contact surface.

13. The positioning and stabilizing structure according to any one of claims 1 to 12, wherein the lower end of the textile sleeve is fixed to the attachment area by an adhesive or otherwise bonded.

14. The positioning and stabilizing structure according to claim 3, wherein the lower end of the textile sleeve is fixed or otherwise bonded to the attachment area by molding the first collar over the lower or upper end of the inner tube.

15. The positioning and stabilizing structure according to claim 3, wherein the lower end of the textile sleeve is fixed or otherwise bonded to the attachment area by molding the second collar over one of the lower or upper ends of the inner tube.

16. The positioning and stabilizing structure according to any one of claims 4 to 12, wherein at least a portion of the outer side of the first collar is the first surface forming at least a portion of the flow path through the hollow interior of the inner tube.

17. The positioning and stabilizing structure according to any one of claims 1 to 16, wherein at least a portion of the first surface includes the engagement portion configured to engage with the complementary engagement portion disposed in one of the connection port or sealing formation structures.

18. The positioning and stabilizing structure according to any one of claims 4 to 12, wherein the first collar includes an end cap.

19. The positioning and stabilizing structure of claim 18, wherein the end cap is connected to the first collar on a surface opposite to the first contact surface of the first collar.

20. The positioning and stabilizing structure according to claim 18 or claim 19, wherein the attachment area is the junction between the end cap and the first collar.

21. The positioning and stabilizing structure according to any one of claims 18 to 20, wherein the end cap is integrally formed with the first collar.

22. The positioning and stabilizing structure according to any one of claims 15 to 20, wherein the engagement between the end cap and the first collar is a groove or recess.

23. The positioning and stabilizing structure according to any one of claims 15 to 22, wherein the lower end of the textile sleeve is fixed or otherwise bonded to the attachment area by molding the end cap over the first collar.

24. The positioning and stabilizing structure according to any one of claims 1 to 23, wherein the conduit connection structure is disposed at both the lower end and the upper end of the inner tube.

25. The positioning and stabilizing structure according to any one of claims 1 to 24, wherein the conduit connection structure is composed of one or more plastic materials, said plastic material being polycarbonate (PCB), polypropylene (PPE), nylon, or mixtures thereof.

26. The positioning and stabilizing structure according to any one of claims 1 to 25, wherein the inner tube is composed of an elastomer.

27. The positioning and stabilizing structure according to claim 26, wherein the elastomer is composed of silicone resin, thermoplastic elastomer (TPE), thermoplastic polyurethane (TPU) or another elastomer material or a mixture thereof.

28. The positioning and stabilizing structure according to any one of claims 1 to 27, wherein the outer textile sleeve is composed of a thermoplastic material.

29. The positioning and stabilizing structure according to claim 28, wherein the heat-fusible material is yarn.

30. The positioning and stabilizing structure according to any one of claims 1 to 28, wherein one of the lower and upper ends of the textile sleeve is heat-treated to form a flange.

31. The positioning and stabilizing structure of claim 30, wherein the flange is received by the attachment region of the conduit connection structure.

32. The positioning and stabilizing structure according to any one of claims 1 to 31, wherein both the lower and upper ends of the textile sleeve are heat-treated to form flanges.

33. A gas delivery tube for a positioning and stabilizing structure, wherein the positioning and stabilizing structure is configured with: a connection port located on the top of a patient's head; and a sealing formation structure configured and arranged to seal with an area of ​​the patient's face surrounding an inlet of the patient's airway to deliver an airflow at a therapeutic pressure at least 6 cmH2O above ambient air pressure throughout the patient's respiratory cycle during use, wherein the gas delivery tube is configured to receive the airflow from the connection port to the sealing formation structure, the gas delivery tube comprising: An inner tube includes a tube wall defining a hollow interior, the hollow interior forming a flow path for air to flow from the connection port to the sealing structure, and wherein the inner tube is configured with an upper end and a lower end. An outer textile sleeve, the outer textile sleeve having an upper end and a lower end; and A conduit connection structure is disposed at at least one of the upper and lower ends of the inner tube, wherein the conduit connection structure is configured to connect the inner tube to either a connection port or a sealing structure, wherein the conduit connection structure is configured with a first surface that forms part of a flow path through the hollow interior of the inner tube, and wherein the conduit connection structure is configured with a second surface that is away from the flow path through the hollow interior of the inner tube and forms at least a portion of an attachment region. The attachment region is configured to receive at least one of the upper and lower ends of the outer textile sleeve.

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