Fabric seal-forming structure having multiple curvatures

Abstract

A patient interface includes a seal-forming structure having a textile membrane with at least one hole such that a flow of air at a therapeutic pressure is delivered to at least an entrance to a patient's nares and / or an entrance to a patient's mouth. In use, the seal-forming structure is structured and arranged to maintain a therapeutic pressure in a plenum chamber throughout a patient's respiratory cycle. The textile membrane includes a first portion that remains in a relaxed state and a second portion that remains in a tensioned state. The tensioned state of the second portion is structured to allow the seal-forming structure to include a three-dimensional shape having multiple curvatures.

Description

[0001] 1. Cross-references to related applications

[0002] This application claims priority to Australian Provisional Application No. 2020902371, filed July 9, 2020, and to U.S. Application No. 16 / 850,803, filed April 16, 2020, which is a continuation-in-part of International Application No. PCT / IB2019 / 058832, filed October 16, 2019, the entire contents of which are incorporated herein by reference.

[0003] International Application PCT / IB2019 / 058832 claims the benefit of U.S. Provisional Application No. 62 / 805,147, filed February 13, 2019, and also claims the benefit of Australian Provisional Application No. AU2018904886, filed December 21, 2018, and Australian Provisional Application No. AU2018903752, filed October 16, 2018, the entire contents of each of which are incorporated herein by reference. 2 Background Technology 2.1 Technical Field

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

[0007] 2.2 Description of relevant technologies

[0008] 2.2.1 The human respiratory system and its disorders

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

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

[0011] There are a range of breathing disorders. Some disorders can be characterized by specific events, such as respiratory arrest, insufficiency, and hyperventilation.

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

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

[0014] Respiratory failure is a broad term encompassing respiratory disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure may cover some or all of the following disorders.

[0015] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormally rapid breathing during exercise.

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

[0017] 2.2.2 Treatment

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

[0019] 2.2.2.1 Respiratory pressure therapy

[0020] Respiratory pressure therapy involves 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 tank ventilators or cuirass ventilators).

[0021] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or unsightly, among other things.

[0022] 2.2.2.2 Flow Therapy

[0023] Not all respiratory therapies are designed to provide a prescribed therapeutic pressure. Some respiratory therapies aim to deliver a prescribed respiratory volume by transmitting an inspiratory flow rate profile over a target duration, possibly superimposed on a positive baseline pressure. In other cases, the patient's airway interface is "open" (unsealed), and the respiratory therapy may only supplement the patient's own spontaneous breathing with conditioned or enriched gas. In one example, high-flow-rate therapy (HFT) provides a continuous stream of heated, humidified air to the airway inlet at a "therapeutic flow rate" through an unsealed or open patient interface, which remains substantially constant throughout the respiratory cycle. The nominal therapeutic flow rate should be set above the patient's maximum inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high-flow-rate air at the airway inlet improves ventilation efficiency by flushing or washing away expired CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as dead space therapy (DST). Other benefits may include increased warmth and humidification (which may aid in secretion management) and the potential for moderately increased airway pressure. As an alternative to a constant flow rate, a therapeutic flow rate can follow a curve that varies throughout the respiratory cycle.

[0024] Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. Doctors can prescribe a continuous flow of oxygen-enriched air to be delivered to the patient's airway at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.) and a specified oxygen concentration (from 21% to 100% of the oxygen fraction in ambient air).

[0025] 2.2.2.3 Supplementing oxygen

[0026] For some patients, oxygen therapy can be used in conjunction with respiratory pressure therapy or HFT, which involves adding supplemental oxygen to a pressurized airflow. When oxygen is added to respiratory pressure therapy, this is called supplemental oxygen therapy (RPT). When oxygen is added to HFT, the resulting treatment is called supplemental oxygen therapy (HFT).

[0027] 2.2.3 Respiratory Therapy System

[0028] 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 symptoms without treating them.

[0029] 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.

[0030] 2.2.3.1 Patient Interface

[0031] 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 mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cmH2O to the airway. For flow-based treatments such as nasal HFT, the patient interface is configured to inflate the nostrils, but a complete seal is explicitly avoided. An example of such a patient interface is a nasal cannula.

[0032] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems for underwater swimming or diving may be constructed to prevent water from flowing in from external high pressure, rather than maintaining air at a pressure higher than the environment inside.

[0033] Some masks may be clinically disadvantageous for this technology, for example, in cases where they block airflow through the nose and only allow it through the mouth.

[0034] If some masks require patients to insert a portion of the mask structure into their mouths to form and maintain a seal through their lips, they may be uncomfortable or not feasible for this technology.

[0035] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0036] The design of the patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly from person to person. Because the head comprises bones, cartilage, and soft tissues, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during the duration of a breathing therapy session.

[0037] Due to these challenges, some face shields suffer from one or more of the following problems: obtrusive, unattractive, expensive, mismatched, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. Incorrect face shield sizing can lead to decreased adherence, reduced comfort, and poorer patient outcomes. For example, face shields designed solely for pilots, face shields designed as part of personal protective equipment (such as filtering face shields), SCUBA face shields, or face shields designed for administering anesthetics may be acceptable for their original application, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment. This is especially true if the face shield is worn during sleep.

[0038] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing difficulties. However, patient adherence may occur if the mask is uncomfortable or difficult to use. Since patients are often advised to clean their masks regularly, they may not clean them if they are difficult to clean (e.g., difficult to assemble or disassemble), which could affect adherence.

[0039] While masks designed for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea can be used for other applications.

[0040] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0041] 2.2.3.1.1 Sealing Formation Structure

[0042] Patient interfaces may include sealing structures. Because they come into direct contact with the patient's face, the shape and configuration of the sealing structure can directly affect the effectiveness and comfort of the patient interface.

[0043] 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.

[0044] A sealing structure that works effectively in one area of ​​a patient's face may not be suitable for another, for example, because the shape, structure, variability, and sensitivity of different areas of the patient's face vary. For instance, a seal on swimming goggles that cover a patient's forehead may not be suitable for use on a patient's nose.

[0045] Certain seal-forming structures can be designed for mass production, making a design suitable, comfortable, and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0046] 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 face-to-face with the patient's face. The seal-forming structure may include an air or fluid-filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the surface, and additional force will be required to force the patient interface against the face to achieve a seal.

[0047] Another type of seal-forming structure incorporates a sheet-like seal of thin material positioned around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous type of seal-forming section, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or bend during use, leading to leakage.

[0048] Another type of seal-forming structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0049] Another form of sealing can be achieved using adhesives. Some patients may find it inconvenient to constantly apply and remove adhesives from their face.

[0050] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0051] One form of nasal pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0052] ResMed Ltd. has manufactured the following products that combine a nose pillow: SWIFT TM Nose pillow mask, SWIFT TM II Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and MIRAGE LIBERTY TM Full-face mask. The following patent application assigned to ResMed Ltd. describes an example of a nose pillow mask: International Patent Application WO 2004 / 073,778 (which describes a ResMed Ltd. SWIFT mask). TM Other aspects of the nose pillow); U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc.'s SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe ResMed Ltd. MIRAGE LIBERTY) TM Other aspects of the full-face mask); International Patent Application WO 2009 / 052,560 (which describes ResMed Ltd.'s SWIFT) TM Other aspects of the FX nose pillow).

[0053] 2.2.3.1.2 Positioning and Stabilization

[0054] The sealing structure of the patient interface used in positive pressure therapy is subject to a force corresponding to the air pressure that would disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain it in a sealed relationship with the appropriate part of the face.

[0055] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, using adhesives may be uncomfortable for some people.

[0056] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following: ill-fitting, bulky, uncomfortable, and awkward to use.

[0057] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0058] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to provide one or more of the aforementioned treatments, such as by operating the device to generate an airflow to deliver it to an airway interface. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Therefore, an RPT device can also function as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0059] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0060] An example of a specific requirement for certain RPT devices is noise.

[0061] Noise output level table for existing RPT devices (only one sample, measured in CPAP mode using the test method specified in ISO 3744 at 10 cmH2O).

[0062]

[0063] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators such as the ResMed Stellar™ series of adult and pediatric ventilators can support a range of patients with invasive and non-invasive non-dependent ventilation for the treatment of a variety of conditions, such as, but not limited to, NMD, OHS, and COPD.

[0064] The ResMed Elisée™ 150 and ResMed VS III™ ventilators provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients to treat a variety of conditions. These ventilators offer volumetric and pressure ventilation modes with single- or dual-branch circuits. RPT devices typically include a pressure generator, such as an electric motor-driven blower or a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, airflow to the patient's airway can be supplied under positive pressure. The RPT device outlet is connected via an air circuit to a patient interface such as those described above.

[0065] The designer of a device may be presented with an almost infinite number of options. Design standards often conflict, meaning that some design choices are far from unconventional or unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to small and subtle changes in one or more parameters.

[0066] 2.2.3.3 Air Circuit

[0067] An air circuit is a conduit or tube constructed and arranged to allow airflow in use to propagate between two components of a respiratory therapy system, such as the RPT device and the patient interface. In some cases, individual branches of the air circuit can be used for both inhalation and exhalation. In other cases, a single branch of the air circuit can be used for both inhalation and exhalation.

[0068] 2.2.3.4 Humidifier

[0069] Delivering an unhumidified airflow can lead to airway dryness. Using a humidifier with an RPT device and patient interface to generate humidified gas minimizes dryness of the nasal mucosa and increases patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air.

[0070] A range of artificial humidification devices and systems are known, however they may not meet the specific requirements of medical humidifiers.

[0071] When needed, typically in areas where patients may sleep or rest (e.g., in hospitals), medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to ambient air. Medical humidifiers for bedside placement can be very small. Medical humidifiers can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed by the patient; however, these systems also humidify and / or heat the entire room, which can cause discomfort to the occupant. Furthermore, medical humidifiers may have stricter safety restrictions than industrial humidifiers.

[0072] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide insufficient humidification, and some may be difficult or inconvenient for patients to use.

[0073] 2.2.3.5 Data Management

[0074] There are many clinical reasons to obtain data to determine whether a patient is “adhering” to a prescription treatment for respiratory therapy, such as if the patient has used their RPT device according to one or more “adherence rules.” One example of an adherence rule for CPAP therapy is to require the patient to use the RPT device for at least four hours each night for at least 21 or 30 consecutive days to be considered adherent. To determine patient adherence, RPT device providers, such as healthcare providers, can manually obtain data describing the patient’s treatment with the RPT device, calculate usage over the predetermined time period, and compare it 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 can inform the patient of the third part of adherence.

[0075] Patient treatment can benefit from other aspects of communication between treatment data and third-party or external systems.

[0076] Existing methods for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0077] 2.2.3.6 Mandibular repositioning

[0078] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance, available from a dentist or other vendor, that holds the jaw (mandible) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes it afterward. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom-made or manufactured in a standard form and include an occlusal impression portion designed to fit the patient's teeth. This mechanical protrusion of the jaw expands the space behind the tongue, applies tension to the pharyngeal walls, thereby reducing airway collapse and mitigating palatal vibrations.

[0079] In some examples, the mandibular advancement device may include an upper splint designed to engage or fit with teeth on the upper jaw or maxilla, and a lower splint designed to engage or fit with teeth on the upper jaw or mandible. The upper and lower splints are laterally connected together by a pair of links. The pair of links are symmetrically fixed to the upper and lower splints.

[0080] In this design, the length of the link is chosen so that the mandible is held in an anteriorly positioned position when the MRD is placed in the patient's mouth. The length of the link can be adjusted to change the level of mandibular protrusion. The dentist can determine the level of mandibular protrusion, which will determine the length of the link.

[0081] Some MRDs are constructed to push the mandible relative to the maxilla, while others, such as ResMed Narval CC... TM Other MADs, such as the MRD, are designed to keep the mandible in an forward position. The device also reduces or minimizes side effects on the teeth and temporomandibular joint (TMJ). Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0082] 2.2.3.7 Vent technology

[0083] Some forms of therapeutic systems may include a vent to allow exhaled carbon dioxide to escape. 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.

[0084] Ventilation ports may include openings through which air can flow when a mask is used. Many such ventilation ports are noisy. Other ventilation ports may become blocked during use, thus providing insufficient airflow. Some ventilation ports may, for example, disrupt the sleep of the patient's bed partner by causing noise or congested airflow.

[0085] ResMed has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. US 2009 / 0044808.

[0086] The noise meter for the existing face mask (ISO 17510-2:2007, pressure of 10 cmH2O at 1 m)

[0087]

[0088] ( (Only one sample was measured in CPAP mode using the test method specified in ISO 3744 at 10 cmH2O).

[0089] The sound pressure levels of various objects are shown below.

[0090]

[0091] 2.2.4 Screening, Diagnosis and Monitoring Systems

[0092] Polysomnography (PSG) is a routine system used for the diagnosis and monitoring of cardiopulmonary diseases and typically involves specialized clinicians applying the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), and electromyography (EMG). PSG for sleep-disordered breathing involves two nights of clinical observation: one night for pure diagnosis and the second night for a clinician to titrate treatment parameters. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0093] Screening and diagnosis typically describe the identification of a disease based on symptoms and signs. Screening usually provides a yes / no result, indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis may produce clinically applicable information. Screening and diagnosis are often one-off processes, while monitoring of disease progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0094] Clinicians can appropriately screen, diagnose, or monitor patients based on visual observation of PSG signals. However, there are situations where clinicians may be unavailable or unaffordable. Different clinicians may have differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. 3. Summary of the Invention

[0096] 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.

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

[0098] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0099] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0100] One form of this technology is a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet including at least the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure within a range of approximately 4 cmH2O to approximately 30 cmH2O above the ambient air pressure during use throughout the patient's respiratory cycle while the patient is asleep, in order to improve sleep-disordered breathing; the patient interface includes:

[0101] An inflatable chamber, at least partially forming a cavity pressurizable to a treatment pressure at least 6 cmH2O above ambient pressure, the inflatable chamber including an inflatable chamber inlet port, the size and structure of which are adapted to receive an airflow at the treatment pressure for patient breathing; and

[0102] A sealed structure is formed.

[0103] One form of this technology includes a fabric sealing formation structure having a bridging portion between a first hole and a second hole, the bridging portion being curled to be held at a greater tension than the rest of the fabric membrane.

[0104] Another aspect of this technology is a sealing structure having a fabric membrane connected to a flexible support structure in a relaxed state, wherein the bridging portion of the fabric membrane is rolled up to be held under greater tension than the rest of the fabric membrane.

[0105] Another aspect of this technology is a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet including at least the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure within a range of approximately 4 cmH2O to approximately 30 cmH2O above the ambient air pressure during use throughout the patient's respiratory cycle while the patient is asleep, in order to improve sleep-disordered breathing; said patient interface includes:

[0106] An inflatable chamber, at least partially forming a cavity pressurizable to a treatment pressure at least 6 cmH2O above ambient pressure, the inflatable chamber including an inflatable chamber inlet port, the size and structure of which are adapted to receive an airflow at the treatment pressure for patient breathing; and

[0107] The sealing structure has the following characteristics:

[0108] A fabric membrane, constructed and arranged to form a seal with the area of ​​the patient's face surrounding the airway inlet below the bridge of the nose, wherein a portion of the fabric membrane has a seal-forming structure constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use.

[0109] in:

[0110] The fabric membrane remains in a relaxed state, and

[0111] This section maintains greater tension than the rest of the fabric membrane, for example, by selectively tensioning it.

[0112] In some respects, the fabric membrane has at least one or two formed holes, such that an airflow under the treatment pressure is delivered to at least the inlet of the patient's airway.

[0113] In some aspects, this portion is tensioned using various techniques, including curling at one or more portions of the fabric membrane, such as the central portion and / or bridging portions. Alternatively, or in addition to the central or bridging portions, one or more other portions of the fabric membrane may be tensioned, such as by curling or other techniques. The fabric membrane may be supported by a flexible support that can be selectively tensioned as an alternative to or supplement to the selective tensioning of one or more portions of the fabric membrane.

[0114] Another aspect of this technology is a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet including at least the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure within a range of approximately 4 cmH2O to approximately 30 cmH2O above the ambient air pressure during use throughout the patient's respiratory cycle while the patient is asleep, in order to improve sleep-disordered breathing; said patient interface includes:

[0115] An inflatable chamber, at least partially forming a cavity pressurizable to a treatment pressure at least 6 cmH2O above ambient pressure, the inflatable chamber including an inflatable chamber inlet port, the size and structure of which are adapted to receive an airflow at the treatment pressure for patient breathing; and

[0116] The sealing structure has the following characteristics:

[0117] A fabric membrane, constructed and arranged to form a seal with the area of ​​the patient's face surrounding the patient's airway inlet below the bridge of the nose, the fabric membrane having at least one pore such that an airflow at the therapeutic pressure is delivered to the inlet of at least one patient nostril, the sealing structure being constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use.

[0118] in:

[0119] The fabric membrane includes a first portion held in a relaxed state and a second portion held in a taut state, the taut state of the second portion being configured to allow the sealing-forming structure to include a three-dimensional shape with multiple curvatures.

[0120] In some respects, a) the area of ​​the first portion is larger than the area of ​​the second portion; b) at least one aperture includes a first aperture and a second aperture, each aperture being configured to be placed adjacent to a nostril of the patient during use, and wherein a bridging portion is provided between the first aperture and the second aperture; c) the bridging portion is the second portion and is held in a taut state; d) the bridging portion is curled to be held under greater tension than the first portion of the fabric membrane; e) the bridging portion includes a first segment and a second segment, the first segment being substantially flat and configured to contact the patient during use, and the second segment extending into the inflation chamber; f) the bridging portion is curled using ultrasonic welding and / or adhesive; and / or g) ultrasonic welding and / or adhesive is applied to the second segment.

[0121] In some aspects, the sealing forming structure also includes a flexible support structure for maintaining the fabric membrane in a three-dimensional shape; b) the sealing forming structure includes a single wall, and wherein one end of the flexible support structure contacts the fabric membrane; c) the sealing forming structure includes a pair of walls, wherein the flexible support structure includes a free end, and the fabric membrane is coupled to the flexible support structure at the distal end of the free end, and wherein the free end is spaced apart from the fabric membrane such that the fabric membrane is arranged radially outside the free end; d) the flexible support structure is coupled to the fabric membrane using injection molding; and / or e) the bridging portion is a locating pin after being rolled up.

[0122] In some aspects, a) the fabric membrane includes a first curvature about a first axis intersecting the first and second holes, and wherein, prior to being rolled up, the bridging portion includes a bridging curvature about the first axis in a direction opposite to the rest of the fabric membrane; b) a second axis extends transversely to the first axis and along the bridging portion, and the fabric membrane includes a second curvature about the second axis; c) the second curvature has one of a dome region and a saddle region, and the first curvature has the other of the dome region and the saddle region; d) the second curvature is configured to contact the patient's subnasal point during use; e) a third axis extends transversely to the second axis and is inclined relative to the first axis, and the fabric membrane includes a third curvature about the third axis; f) the third curvature is configured to contact the patient's supralipal region during use; g) a fourth axis extends transversely to the second and third axes and parallel to the first axis, and the fabric membrane includes a fourth curvature about the fourth axis; h) the fourth curvature includes a variable radius of curvature; and / or i) the fourth curvature extends into the principal curvature adjacent to the edge of the fabric membrane.

[0123] In some respects, a) the portion of the first orifice remote from the bridging portion is movable between a first position and a second position; b) the first position is a natural state, and the fabric membrane moves to the second position due to external force; c) in the second position, a portion of the first orifice extends into the inflation chamber; d) the first orifice in the second position comprises a basic teardrop shape; e) in the second position, the first orifice is configured to contact the area around the entrance of one of the patient's nostrils, adjacent to the edge of the nasal ala; and / or f) the portion of the second orifice remote from the bridging portion is movable between the first position and the second position.

[0124] In some aspects, a) the fabric membrane includes a fabric layer and a silicone layer bonded to the fabric layer, the silicone layer being impermeable; b) the silicone layer is approximately 0.5 mm thick; c) the silicone layer is disposed within the cavity and is configured not to come into contact with the patient's skin during use; d) the silicone layer has low stiffness and, when bonded to a flexible support structure, the fabric membrane has high tensile strength.

[0125] In some respects, a) the length of the bridging portion is directly related to the dimensions of the first and second holes; b) due to the tension of the second portion, the fabric membrane is configured to bend around at least two non-parallel axes to form a three-dimensional shape; c) the fabric membrane comprises a multilayer fabric material and a silicone layer connected to the multilayer fabric material; d) the multilayer fabric material comprises a first layer, a second layer, and a third layer, the silicone layer contacting only the first layer, and wherein the third layer is configured to contact the patient's face during use; e) the first and third layers are made of nylon, wherein the second layer is made of spandex; f) the thickness of the fabric membrane is approximately 0.35 mm to 0.45 mm; and / or g) during use, the patient's nose and upper lip only contact the fabric membrane.

[0126] Another aspect of this technology is a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet including at least the patient's nasal inlet, wherein the patient interface is configured to maintain a therapeutic pressure within a range of approximately 4 cmH2O to approximately 30 cmH2O above the ambient air pressure during use throughout the patient's respiratory cycle while the patient is asleep, in order to improve sleep-disordered breathing; said patient interface includes:

[0127] An inflatable chamber, at least partially forming a cavity pressurizable to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and structured to receive an airflow at the treatment pressure for patient breathing; and

[0128] The sealing structure has the following characteristics:

[0129] A fabric membrane, constructed and arranged to form a pressure-assisted seal with the area of ​​the patient's face surrounding the airway inlet below the bridge of the nose, the fabric membrane having a first hole and a second hole, and a bridging portion disposed between the first and second holes, wherein the first and second holes formed therein allow airflow at the therapeutic pressure to be delivered at least to the inlet of the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use.

[0130] A flexible support structure used to hold a fabric membrane in a predetermined shape;

[0131] in:

[0132] The fabric membrane is connected to the flexible support structure in a relaxed state, and

[0133] The bridging portion is curled up, thus maintaining it under greater tension than the rest of the fabric membrane.

[0134] Another aspect of this technology is a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to the patient's nasal inlet and mouth inlet, wherein the patient interface is configured to maintain a therapeutic pressure within a range of approximately 4 cmH2O to approximately 30 cmH2O above the ambient air pressure during use throughout the patient's respiratory cycle while the patient is asleep, in order to improve sleep-disordered breathing; the patient interface includes:

[0135] An inflatable chamber, at least partially forming a cavity pressurizable to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and structured to receive an airflow at the treatment pressure for patient breathing; and

[0136] A sealing structure comprising a fabric membrane configured and arranged to form a pressure-assisted seal with areas of the patient's face surrounding the patient's nasal and oral inlets, the sealing structure comprising:

[0137] The nose, configured to at least partially surround the entrance to the patient's nostrils, and

[0138] The oral cavity portion is configured to at least partially surround an entrance to the patient's mouth.

[0139] The fabric membrane has at least one pore, such that an airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostril and / or the inlet of the patient's mouth, and a sealing structure is configured and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use.

[0140] The fabric membrane includes a first portion held in a relaxed state and a second portion held in a taut state, the taut state of the second portion being configured to allow the sealing structure to include a three-dimensional shape with multiple curvatures.

[0141] In some aspects, a) at least one hole includes: a nasal opening configured to be positioned adjacent to the patient's nostrils; and an oral cavity portion hole configured to be positioned adjacent to the patient's mouth during use; b) a bridging portion extends across the nasal opening and divides the nasal opening into a first hole and a second hole, each of the first hole and the second hole being configured to be adjacent to one of the patient's nostrils during use; c) the bridging portion is a second portion and is held in a taut state; and / or d) the bridging portion is curled using ultrasonic welding and / or adhesive.

[0142] In some aspects, a) the first part at least partially includes an oral cavity portion; b) the first part includes an oral cavity portion and a segment of a nose; c) the sealing-forming structure further includes a flexible support structure for maintaining the fabric membrane in a three-dimensional shape; d) the flexible support structure includes at least one support rib that engages with the oral cavity portion within the inflatable chamber cavity; e) the flexible support structure further includes a second rib disposed within the cavity, the support rib extending between the second rib and the oral cavity portion; f) due to the tension of the second part, the fabric membrane of the sealing-forming structure bends about at least two non-parallel axes to form a three-dimensional shape; g) the oral cavity portion bends about at least two non-parallel axes; and / or h) the fabric membrane includes a fabric layer and a silicone layer coupled to the fabric layer, the silicone layer having impermeable properties.

[0143] In some aspects, the sealing structure is composed of a fabric membrane having a first segment and a second segment spaced apart from the first segment; b) the sealing structure also includes a flexible support portion made of a material other than the fabric membrane, the flexible support portion being disposed between the first and second segments; c) in use, the second segment is positioned higher than the first segment; d) the second segment is at least partially disposed between the ends of the first segment; e) at least one orifice includes a nasal opening configured to be positioned adjacent to the patient's nostrils and an oral cavity portion orifice configured to be positioned adjacent to the patient's mouth. f) at least one hole includes a nasal opening configured to be located adjacent to the patient's nostrils and an oral cavity portion hole configured to be located adjacent to the patient's mouth, wherein the second segment completely forms the periphery of the nasal opening; and the periphery of the oral cavity portion hole is at least partially formed by a combination of the first segment and the second segment; g) the first segment forms at least a portion of the oral cavity portion and includes an annular shape; and / or h) the second segment constitutes at least a portion of the oral cavity portion and includes a U-shape.

[0144] In some respects, a) a single continuous sheet of fabric membrane is used to construct the oral and nasal portions; b) the patient's nose and upper lip are configured to contact only the fabric membrane during use; and / or c) a foam insert, which is coupled to the sealing-forming structure and contacts the patient's nasal ala during use.

[0145] In some respects, the fabric membrane is configured to include bending around at least two non-parallel axes, since the bridging portion is rolled up.

[0146] In some cases, ultrasonic welding and / or adhesives are used to curl the bridging portion.

[0147] In some respects, the length of the bridging section is directly related to the dimensions of the first hole and the second hole.

[0148] In some respects, the bridging section includes a first segment and a second segment, the first segment being substantially flat and configured to contact the patient during use, and the second segment extending into the inflation chamber.

[0149] In some respects, ultrasonic welding and / or adhesives are applied to the second segment.

[0150] In some respects, the sealing-forming structure includes a single wall, and one end of the flexible support structure contacts the fabric membrane.

[0151] In some aspects, the sealing-forming structure includes a pair of walls, wherein the flexible support structure includes a free end, and the fabric membrane is coupled to the flexible support structure at the distal end of the free end, and wherein the free end is spaced apart from the fabric membrane, such that the fabric membrane is arranged radially outside the free end.

[0152] In some aspects, injection molding is used to attach flexible support structures to fabric membranes.

[0153] In some respects, the bridging portion is a coiled positioning bolt.

[0154] In some respects, the fabric membrane includes a fabric layer and a silicone layer bonded to the fabric layer, the silicone layer having impermeable properties.

[0155] In some aspects, the thickness of the silicone layer is approximately 0.5 mm.

[0156] In some respects, the fabric membrane comprises a multilayer fabric material and a silicone layer bonded to the multilayer fabric material.

[0157] In some respects, the multilayer fabric material includes a first layer, a second layer, and a third layer, wherein, in use, the silicone layer only contacts the first layer, while the third layer is configured to contact the patient's face.

[0158] In some respects, the first and third layers are made of nylon, and the second layer is made of spandex.

[0159] In some respects, the silicone layer is placed inside the cavity and configured not to come into contact with the patient's skin during use.

[0160] In some respects, the silicone layer has low hardness characteristics, and when attached to a flexible support structure, the fabric membrane includes high tensile strength.

[0161] In some aspects, the thickness of the fabric membrane is approximately 0.35 mm to approximately 0.45 mm.

[0162] In some aspects, the fabric membrane includes a first curvature about a first axis intersecting the first opening and the second opening, and wherein, prior to curling, the bridging portion includes a bridging curvature about the first axis in the opposite direction to the rest of the fabric membrane.

[0163] In some respects, the second axis is transverse to the first axis and extends along the bridging portion, and the fabric membrane includes a second curvature around the second axis.

[0164] In some respects, the second curvature has a concavity that is the opposite of the first curvature.

[0165] In some respects, the second curvature is configured to contact the patient's subnasal point during use.

[0166] In some respects, the third axis extends transversely to the second axis and is inclined relative to the first axis, and the fabric membrane includes a third curvature around the third axis.

[0167] In some respects, the third bend is configured to contact the upper part of the patient's lips during use.

[0168] In some respects, the fourth axis extends transversely to the second and third axes and parallel to the first axis, and the fabric membrane includes a fourth curvature around the fourth axis.

[0169] In some respects, the fourth curvature includes a variable radius of curvature.

[0170] In some respects, the fourth curvature extends into the principal curvature from the edge of the adjacent fabric membrane.

[0171] In some respects, a portion of the first hole away from the bridging portion can move between a first position and a second position.

[0172] In some respects, the first position is the natural state, and the fabric membrane moves to the second position due to external forces.

[0173] In some respects, a portion of the first hole extends into the inflation chamber at a second location.

[0174] In some respects, the first hole in the second position comprises a basic teardrop shape.

[0175] In some respects, in the second position, the first opening is configured to contact the periphery of the entrance to one of the patient's nostrils, near the edge of the nasal ala.

[0176] In some respects, a portion of the second hole away from the bridging section can move between the first and second positions.

[0177] In some respects, the patient's nose and upper lip are configured to only come into contact with the fabric membrane during use.

[0178] In some respects, the patient interface is a nose pad, nose support, mouth and nose pad, ultra-compact full-face mask, or full-face mask.

[0179] In another aspect of the invention, a patient interface is provided for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet including at least a patient's nasal inlet, wherein the patient interface is configured to maintain a therapeutic pressure within a range of about 4 cmH2O to about 30 cmH2O above the ambient air pressure during use throughout the patient's respiratory cycle while the patient is asleep, in order to improve sleep-disordered breathing; said patient interface includes:

[0180] An inflatable chamber, at least partially forming a cavity pressurizable to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and structured to receive an airflow at the treatment pressure for patient breathing; and

[0181] A sealing structure comprising a fabric membrane configured and arranged to form a pressure-assisted seal with the area of ​​the patient's face surrounding the airway inlet below the bridge of the nose. The fabric membrane has a first hole and a second hole, and a bridging portion disposed between the first and second holes, wherein the first and second holes are formed, such that an airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils. The sealing structure is configured and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use.

[0182] in:

[0183] The sealing structure includes a flexible support structure to hold the fabric membrane in a predetermined curved shape. The fabric membrane includes a first curvature about a first axis and a second curvature about a second axis, the second curvature being generally transverse to the first axis. The first axis is configured to be generally transverse to the sagittal plane of the patient's head, such that the first curvature includes a vertex in a posterior direction, such that the first curvature passes through the nasolabial groove of the patient's nose, and the second axis is configured to be generally parallel to the sagittal plane, such that the second curvature includes a vertex in a downward direction, such that in use the second curvature is a saddle-shaped region and has a generally positive curvature relative to the upper lip of the patient.

[0184] The bridging portion has a third curvature opposite to the first curvature, and this third curvature limits the creases along the surface of the fabric membrane.

[0185] The fabric membrane is connected to the flexible support structure in a relaxed state.

[0186] In use, the fabric membrane is configured to press against the patient's face so that the patient's nose is not contained within the cavity; and

[0187] The fabric membrane can be attached to a flexible support structure along its outer periphery, allowing the fabric membrane to extend radially inward beyond the support structure.

[0188] In some respects, the bridging section is curled to maintain the third curvature and restrict the flipping to the first curvature.

[0189] In some cases, ultrasonic welding and / or adhesives are used to curl the bridging portion.

[0190] In some respects, the fabric membrane is essentially airtight.

[0191] In some respects, the fabric membrane includes a fabric layer and a silicone layer bonded to the fabric layer, the silicone layer having impermeable properties.

[0192] In some aspects, the thickness of the silicone layer is approximately 0.5 mm.

[0193] In some respects, the silicone layer is arranged within the cavity and configured not to come into contact with the patient's skin during use.

[0194] In some respects, the silicone layer has low hardness, and the fabric layer includes high tensile strength when attached to a support structure.

[0195] In some aspects, the thickness of the fabric membrane is approximately 0.35 mm to approximately 0.45 mm.

[0196] In some respects, the sealing-forming structure includes a single wall, and one end of the flexible support structure contacts the fabric membrane.

[0197] In some aspects, the sealing structure includes a pair of walls, wherein the flexible support structure includes a free end, and the fabric membrane is coupled to the flexible support structure at the distal end of the free end, and wherein the free end is spaced apart from the fabric membrane such that the fabric membrane is arranged radially outside the free end.

[0198] In some respects, the first opening includes a first arched portion having a generally first curvature, and the first arched portion is configured to be positioned within the patient's first nostril.

[0199] In some respects, the first arched portion is configured to flip from having a generally first curvature to having a generally third curvature after being positioned within the patient's first nostril, the arched portion being configured to enclose the periphery of the first nostril entrance.

[0200] In some respects, the second opening includes a second arched portion having a generally first curvature, and the second arched portion is configured to be positioned within the patient's second nostril.

[0201] In some respects, the first hole comprises a generally circular shape and is configured to comprise a generally teardrop shape after contact with the patient's face.

[0202] In some respects, the fabric membrane is configured to contact only the patient's upper lip, lower nasal point, and nasal protuberance when in use.

[0203] In some cases, injection molding is used to attach flexible supports to fabric membranes.

[0204] In some respects, the fabric membrane includes a fourth curvature around a fourth axis, which is a generally saddle-shaped region with a positive curvature relative to the patient's subnasal point when in use, and the fourth axis is generally transverse to the first and second axes.

[0205] In some respects, the region affected by the second curvature is formed by a generally rectangular region surrounding the first and second holes, the generally rectangular region having a generally tangential relationship with respect to the first hole and with respect to the second hole, wherein the generally tangential relationship limits the creases in the fabric membrane.

[0206] In another aspect of the present technology, a patient interface is provided for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet including at least a patient's nasal inlet, wherein the patient interface is configured to maintain a therapeutic pressure within a range of about 4 cmH2O to about 30 cmH2O above the ambient air pressure during use throughout the patient's respiratory cycle while the patient is asleep, in order to improve sleep-disordered breathing; said patient interface includes:

[0207] An inflatable chamber, at least partially forming a cavity pressurizable to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and structured to receive an airflow at the treatment pressure for patient breathing; and

[0208] A sealing structure comprising a fabric membrane configured and arranged to form a pressure-assisted seal with the area of ​​the patient's face surrounding the airway inlet below the bridge of the nose. The fabric membrane has a first hole and a second hole, and a bridging portion disposed between the first and second holes, wherein the first and second holes are formed, such that an airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils. The sealing structure is configured and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use.

[0209] in:

[0210] The sealing structure includes a flexible support structure to hold the fabric membrane in a predetermined curved shape. The fabric membrane includes a first curvature about a first axis and a second curvature about a second axis, the second curvature being generally transverse to the first axis. The first axis is configured to be generally transverse to the sagittal plane of the patient's head, such that the first curvature includes a vertex in a posterior direction, and that in use, the first curvature is generally a negative dome curvature relative to the upper part of the patient's lips. The second curvature axis is configured to be generally parallel to the sagittal plane, such that the second curvature includes a vertex in a downward direction, and that in use, the second curvature is a generally saddle-shaped region and a positive curvature relative to the patient's nasal protuberance.

[0211] The bridging portion has a third curvature opposite to the first curvature, and this third curvature limits the creases along the surface of the fabric membrane.

[0212] The fabric membrane is connected to the flexible support structure in a relaxed state.

[0213] In use, the fabric membrane is configured to press against the patient's face so that the patient's nose is not contained within the cavity, and

[0214] The fabric membrane is attached to the flexible support structure along the outer periphery of the fabric membrane, such that the fabric membrane extends radially inward beyond the support structure.

[0215] In some respects, the fabric membrane includes a fourth curvature about a fourth first axis, the fourth curvature being configured to be generally parallel to the first axis, such that the fourth curvature includes a vertex in a posterior direction, such that the fourth curvature passes around the nasolabial groove of the patient's nose.

[0216] In some respects, the bridging section is curled to maintain the third curvature and restrict the flipping to the first curvature.

[0217] In some cases, ultrasonic welding and / or adhesives are used to curl the bridging portion.

[0218] In some respects, the fabric membrane is essentially airtight.

[0219] In some respects, the fabric membrane includes a fabric layer and a silicone layer bonded to the fabric layer, the silicone layer having impermeable properties.

[0220] In some aspects, the thickness of the silicone layer is approximately 0.5 mm.

[0221] In some respects, the silicone layer is disposed within the cavity and is configured not to come into contact with the patient's skin during use.

[0222] In some respects, the silicone layer has low hardness, and the fabric layer includes high tensile strength when attached to a support structure.

[0223] In some aspects, the thickness of the fabric membrane is approximately 0.35 mm to approximately 0.45 mm.

[0224] In some respects, the sealing-forming structure includes a single wall, and one end of the flexible support structure contacts the fabric membrane.

[0225] In some aspects, the seal formation includes a pair of walls, wherein the flexible support structure includes a free end, and a fabric membrane is coupled to the flexible support structure distal to the free end, and wherein the free end is spaced apart from the fabric membrane such that the fabric membrane is arranged radially outside the free end.

[0226] In some respects, the first opening includes a first arched portion having a generally first curvature, and the first arched portion is configured to be positioned within the patient's first nostril.

[0227] In another aspect of this technology, a sealing structure has:

[0228] A fabric membrane, constructed and arranged to form a pressure-assisted seal with the area of ​​the patient's face surrounding the airway inlet below the bridge of the nose, the fabric membrane having a first hole and a second hole, and a bridging portion disposed between the first and second holes, wherein the first and second holes are formed, such that an airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils, and the seal-forming structure is constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use.

[0229] A flexible support structure used to hold a fabric membrane in a predetermined shape;

[0230] in:

[0231] The fabric membrane is connected to the flexible support structure in a relaxed state, and

[0232] The bridging portion is curled up, thus maintaining it under greater tension than the rest of the fabric membrane.

[0233] Another aspect of this technology is a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient airway inlet including at least a patient's nasal inlet, wherein the patient interface is configured to maintain a therapeutic pressure within a range of approximately 4 cmH2O to approximately 30 cmH2O above the ambient air pressure during use throughout the patient's respiratory cycle while the patient is asleep, in order to improve sleep-disordered breathing; said patient interface includes:

[0234] An inflatable chamber, at least partially forming a cavity pressurizable to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and structured to receive an airflow at the treatment pressure for patient breathing; and

[0235] The sealing structure has the following characteristics:

[0236] A fabric membrane, constructed and arranged to form a pressure-assisted seal with the area of ​​the patient's face surrounding the airway inlet, below the bridge of the nose. A portion of the fabric membrane has a seal-forming structure constructed and arranged to maintain the therapeutic pressure within the cavity throughout the patient's respiratory cycle during use.

[0237] The fabric membrane is kept taut.

[0238] One form of this technology includes a fabric sealing forming structure having a bridging portion between a first hole and a second hole, wherein the entire fabric sealing forming structure is held in a taut state.

[0239] Another aspect of this technology is a sealing structure having a fabric membrane connected to a flexible support structure in a tensioned state, and the bridging portion of the fabric membrane is substantially flat due to tension.

[0240] Another aspect of this technology is a sealing structure having a fabric membrane connected to a flexible support structure in a taut state before use, the fabric membrane having a substantially flat surface in a taut state in at least one direction before use.

[0241] In some respects, the fabric membrane is tensioned using various techniques, including without curling one or more portions of the fabric membrane (e.g., the central portion and / or bridging portions). The central portion and / or bridging portions can be stretched and substantially flattened before patient use. The fabric membrane can be supported by a flexible support and can be stretched or otherwise tensioned before being attached to the flexible support.

[0242] Another aspect of this technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that complements the body shape of the intended wearer.

[0243] One aspect of this technology is a method for manufacturing equipment.

[0244] One aspect of certain forms of this technology is an easy-to-use medical device, for example, one that is easy to use by people who have no medical training, limited dexterity, limited vision, or limited experience with using this type of medical device.

[0245] One aspect of this technology is a portable RPT device that can be carried by a person, for example, around a person's home.

[0246] One aspect of this technology is a patient interface that can be rinsed in a patient's home (e.g., with soapy water) without the need for specialized cleaning equipment. Another aspect of this technology is a humidifier tank that can be rinsed in a patient's home (e.g., with soapy water) without the need for specialized cleaning equipment.

[0247] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors such as dedicated computers, respiratory monitors, and / or processors for respiratory therapy devices. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0248] Of course, some of these aspects can form sub-aspects of this technology. Moreover, sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0249] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description

[0250] This technology is illustrated by way of example and not limitation in the figures, and similar reference numerals in the figures refer to similar elements, including:

[0251] 4.1 Respiratory Therapy System

[0252] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient is lying supine and sleeping.

[0253] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0254] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is lying on their side while sleeping.

[0255] 4.2 Respiratory System and Facial Anatomy

[0256] 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.

[0257] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0258] Figure 2CIt is a frontal view of a face with several identifiable surface anatomical features, including the upper lip, upper vermilion border, lower vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. The directions of up, down, radial inward, and radial outward are also indicated.

[0259] Figure 2D It is a side view of the head with several identifiable surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal point, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, supraauricular base, and subauricular base. The vertical and horizontal directions are also indicated.

[0260] Figure 2E This is another side view of the head. The Frankfurt plane and the approximate location of the nasolabial angle are indicated. The coronal plane is also shown.

[0261] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial groove, lower lip, upper lip vermilion border, nostrils, subnasal point, columella, nasal protuberance, long axis of the nostrils, and midsagittal plane.

[0262] Figure 2G A side view showing the surface features of the nose.

[0263] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0264] Figure 2I The diagram shows the medial anatomy of the nose a few millimeters from the midsagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0265] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also labeled.

[0266] Figure 2K A side view of the skull showing the surface contours of the head and several muscles is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0267] Figure 2L The frontal lateral view of the nose is shown.

[0268] 4.3 Patient Interface

[0269] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0270] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0271] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0272] Figure 3D A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a zero value.

[0273] Figure 3E A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0274] Figure 3F A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0275] Figure 3G A cushion for a face mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome-shaped and saddle-shaped areas are indicated.

[0276] Figure 3H The pad used for the face mask is shown. The outer surface of the pad is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle-shaped areas and one dome-shaped area are indicated.

[0277] Figure 3I The surface of the structure is shown, in which a one-dimensional hole is present. The planar curve shown forms the boundary of the one-dimensional hole.

[0278] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface shown is in Figure 3I The structure defines a two-dimensional hole.

[0279] Figure 3K It shows Figure 3IA perspective view of the structure, which includes two-dimensional holes and one-dimensional holes. Also shown is... Figure 3I The surface of the two-dimensional hole is defined in the structure.

[0280] Figure 3L A face mask with an inflatable airbag as a cushion is shown.

[0281] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the airbag is also shown. The inner surface defines the two-dimensional openings in the mask.

[0282] Figure 3N It shows crossing Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0283] Figure 3O The left-hand rule is shown.

[0284] Figure 3P The right-hand rule is shown.

[0285] Figure 3Q The left ear, including the spiral of the left ear, is shown.

[0286] Figure 3R The image shows the right ear, including the spiral of the right ear.

[0287] Figure 3S A right-handed spiral is shown.

[0288] Figure 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of sealing membranes in different areas of the face mask.

[0289] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0290] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The view is oriented perpendicular to the center contact plane. Figure 3V The sagittal plane in the middle divides the air chamber into left and right sides.

[0291] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, which is in Figure 3VThe image shows a cutoff point in the sagittal plane. The 'intermediate contact' plane is shown. The intermediate contact plane is perpendicular to the sagittal plane. The direction of the intermediate contact plane corresponds to the direction of chord 3210, which lies in the sagittal plane and contacts the pad of the inflation chamber at the following two points in the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the pad in this region, the intermediate contact plane can be tangent at both the upper and lower points.

[0292] Figure 3X It shows Figure 3U The air chamber 3200 is positioned on the face for use. When the air chamber 3200 is in the use position, the sagittal plane of the air chamber typically coincides with the midsagittal plane of the face. When the air chamber is in the use position, the intermediate contact plane typically corresponds to the 'facial plane'. Figure 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is located approximately on the bridge of the nose, while the lower point 3230 is located on the upper part of the lip.

[0293] 4.4 RPT device

[0294] Figure 4A An RPT device of one form according to the present technology is shown.

[0295] Figure 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. Reference is made to the blower and patient interface to indicate upstream and downstream directions. The blower is defined as upstream of the patient interface, and the patient interface is defined as downstream of the blower, regardless of the actual flow direction at any given moment. Items within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0296] 4.5 Respiratory waveform

[0297] Figure 5 This shows a typical breathing waveform model of a person during sleep.

[0298] 4.6 Patient Interface Based on Current Technology

[0299] Figure 6 This is a perspective view of the patient interface based on an example of the technology worn by the patient.

[0300] Figure 7 This is a perspective view of another example of a patient interface worn by a patient according to this technology.

[0301] Figure 8 It is along Figure 7 The positioning and stabilizing structure of line 8-8 in the diagram.

[0302] Figure 9 yes Figure 8 An enlarged view of part of the positioning and stabilizing structure.

[0303] Figure 10 yes Figure 8 An enlarged view of part of the positioning and stabilizing structure.

[0304] Figure 11 It is positioned on the patient's face. Figure 6 The front view of the mat component.

[0305] Figure 12 This is a front perspective view of a mat assembly according to an example of this technology.

[0306] Figure 13 yes Figure 12 The front view of the mat component.

[0307] Figure 14 yes Figure 12 Top perspective view of the mat component.

[0308] Figure 15 yes Figure 12 A top view of the mat component.

[0309] Figure 16 It is along Figure 12 Cross-sectional view of centerline 16-16.

[0310] Figure 17 It is along Figure 12 Cross-sectional view of centerline 17-17.

[0311] Figure 18 It comes from Figure 16 Zoomed-in details.

[0312] Figures 19 to 21 This is a front perspective view of a pad assembly having a gripping pad disposed on a fabric membrane, according to an example of the present technology.

[0313] Figure 22 This is a perspective view of the patient interface according to another example of this technology.

[0314] Figure 23 It is worn by the patient Figure 22 A perspective view of the patient interface.

[0315] Figure 24 yes Figure 23 A side view of the patient interface.

[0316] Figure 25 yes Figure 23 Front perspective view of the patient interface.

[0317] Figure 26This is a front view of the pad assembly of the patient interface according to an example of this technology.

[0318] Figure 27 yes Figure 26 A top view of the mat component.

[0319] Figure 28 yes Figure 26 A bottom view of the mat component.

[0320] Figure 29 yes Figure 26 Front perspective view of the cushion component.

[0321] Figure 30 yes Figure 26 Rear perspective view of the cushion assembly.

[0322] Figure 31 yes Figure 26 Side perspective view of the cushion assembly.

[0323] Figure 32 yes Figure 26 The front perspective view of the mat assembly shows the interior of the mat assembly.

[0324] Figure 33 yes Figure 26 The front view of the mat assembly shows the interior of the mat assembly.

[0325] Figure 33-1 This is a rear perspective view of a mat assembly according to an example of this technology.

[0326] Figure 33-2 This is a rear perspective view of a mat assembly according to an example of this technology.

[0327] Figure 33-3 This is a rear perspective view of a mat assembly according to an example of the present technology, wherein the sealing portion is made of a single piece of fabric material.

[0328] Figure 33-4 yes Figure 33-3 The rear perspective view of the pad assembly shows a more positive arched curvature of the sealing portion at the position configured to contact the upper part of the patient's lips.

[0329] Figure 33-5 yes Figure 33-4 A top view of the mat component.

[0330] Figure 33-6 yes Figure 33-3 A side perspective view of the cushion assembly, showing the support ribs.

[0331] Figure 33-7 yes Figure 33-3 A side perspective view of the mat assembly, showing its connection to... Figure 33-6 Compared to larger support ribs.

[0332] Figure 33-8 yes Figure 33-3 The rear perspective view of the pad assembly, which has thicker corners in the nasal region to provide a narrower space to accommodate the patient's nose.

[0333] Figure 33-9 yes Figure 33-8 A top view of the mat component.

[0334] Figure 33-10 yes Figure 33-3 A front view of the mat assembly, showing its connection to... Figure 24 The patient interface is compared to the elevated catheter connector section.

[0335] Figure 33-11 yes Figure 33-3 The rear perspective view of the pad assembly shows the foam insert configured to contact the corner of the patient's nasal area.

[0336] Figure 34 Is with Figure 22 Rear view of the pad assembly used with the patient interface.

[0337] Figure 35 yes Figure 34 The front view of the mat component.

[0338] Figure 36 It is observed along line 36-36. Figure 34 Cross-sectional view of the mat assembly.

[0339] Figures 37 to 39 This is a front perspective view of a pad assembly having a gripping pad disposed on a fabric membrane, according to an example of the present technology.

[0340] Figure 40 This is a schematic diagram illustrating the process of providing an airtight layer to a fabric material according to an example of this technology.

[0341] Figure 40-1 This is a schematic diagram of a process for providing an airtight layer to a fabric material according to another example of the present technology.

[0342] Figure 41 It is a schematic diagram depicting the patient's face being presented to the fabric membrane with slight tension before use.

[0343] Figure 42 This is a schematic diagram showing the resultant force exerted on the patient's face by the fabric membrane due to the tensile stress in the fabric membrane.

[0344] Figure 43This is a schematic diagram illustrating the tension applied to the sealing portion of a pad assembly according to an example of this technology.

[0345] Figure 44 This is a schematic diagram illustrating the force exerted on the patient's face by the fabric membrane due to the air pressure within the cavity formed by the cushion assembly.

[0346] Figure 45 and 46 The knitting process is described.

[0347] Figure 47 An example of a warp-knitted fabric according to this technology is shown.

[0348] Figure 48 An example of a weft-knitted fabric according to this technology is shown.

[0349] Figure 49 It is a perspective view of the fabric material folded around the first axis.

[0350] Figure 50 It is folded around the first axis and the second axis. Figure 49 A perspective view of the fabric material. The second axis is not parallel to the first axis, and folds around the second axis create creases and / or wrinkles in the fabric material.

[0351] Figure 51 This is a perspective view of the fabric material used as a sealing structure. The fabric material is folded and treated around three non-parallel axes to limit the formation of creases and / or wrinkles.

[0352] Figure 52 yes Figure 49 A perspective view of a fabric material having a pair of openings cut into the material and a bridging portion located between the two openings.

[0353] Figure 53 yes Figure 52 A perspective view of the fabric material, showing the bridging portion flipped about a second axis parallel to the first axis.

[0354] Figure 54 yes Figure 53 A perspective view of the fabric material, showing the bridging sections under tension via a curling process.

[0355] Figure 55 yes Figure 53 A perspective view of a fabric material folded about a non-parallel axis. The folded bridging portions limit the formation of creases and / or wrinkles in the fabric material.

[0356] Figure 56 yes Figure 55 Detailed views of the fabric material, showing the curvature around different axes.

[0357] Figure 57 It is a detailed drawing of the fabric material, showing the circumference of the opening, which can vary depending on the length of the bridging portion that is rolled up.

[0358] Figure 58 It is by Figure 54 A cross-sectional view of a mat assembly formed from a fabric material. A flexible support structure contacts the fabric material to form a single wall.

[0359] Figure 59 It is by Figure 54 A perspective view of a mat assembly formed from fabric material. A portion of the flexible support structure is spaced apart from the fabric material to form two walls.

[0360] Figure 60 It is by Figure 54 A perspective view of a mat assembly formed from fabric material. The fabric material includes an arched section partially surrounding an opening.

[0361] Figure 61 yes Figure 60 A perspective view of the cushion assembly, showing an inwardly folded arched section such that the opening comprises a generally teardrop shape. Detailed Implementation

[0362] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0363] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any example can be combined with one or more features of another example or other examples. In addition, in any example, any single feature or combination of features can form another example.

[0364] 5.1 Treatment

[0365] In one form, the technology includes a method for treating respiratory disorders, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0366] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0367] In some examples of this technique, mouth breathing is limited, restricted, or prevented.

[0368] 5.2 Respiratory Therapy System

[0369] 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.

[0370] 5.3 Patient Interface

[0371] According to one aspect of the present technology, the noninvasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the inlet of the patient's airway. The sealed patient interface 3000 is thus adapted for delivering positive pressure therapy.

[0372] If the patient interface cannot comfortably deliver even the minimum level of positive pressure to the airway, then the patient interface may not be suitable for respiratory pressure therapy.

[0373] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply with a positive pressure of at least 6 cmH2O relative to the environment.

[0374] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply with a positive pressure of at least 10 cmH2O relative to the environment.

[0375] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply with a positive pressure of at least 20 cmH2O relative to the environment.

[0376] 5.3.1 Sealing Formation Structure

[0377] In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual sealing surface—may vary daily during a given treatment period and vary from patient to patient, depending on a range of factors, including, for example, the position of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0378] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0379] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material, such as silicone rubber.

[0380] The sealing structure 3100 according to this technology can be made of a soft, flexible, and elastic material such as silicone resin.

[0381] In some forms, such as in Figures 6 to 39 In the forms shown, sealing structures 3100, 6100, and 9100 have sealing portions comprising fabric material that may cover all or part of the sealing structures 3100, 6100, and 9100. In some forms, the fabric may comprise a material formed of a fiber network and adapted to be airtight. For example, the fabric may have an airtight membrane on at least one surface, thereby forming a fabric membrane or fabric sealing portion.

[0382] In some forms, the fabric membrane can be configured to stretch elastically in at least one dimension. For example, when the fabric membrane is composed of a fiber network, it is capable of stretching along the longitudinal warp and / or transverse weft directions throughout the entire fabric membrane. In some forms, the fabric membrane is configured to stretch elastically to a greater extent than that achievable with conventional silicone sealant formation structures.

[0383] In some forms, the fabric membrane is constructed to be substantially inelastic in at least one dimension. For example, when the fabric membrane is made of woven fabric material, it is able to substantially resist elongation in either or both of the longitudinal warp or transverse weft directions of the fabric membrane.

[0384] Fabric membranes can be single-layered or multi-layered. In multi-layered forms, the individual layers can be formed using the same material or various different materials, each with unique material properties.

[0385] In some forms, the fabric membrane may include at least one layer that exhibits substantially impermeable properties while retaining the material properties necessary to provide patient comfort and a point of minimal pressure. For example, such as Figure 40As shown, in some forms, the fabric membrane may include an impermeable material 10131 (e.g., a silicone layer) formed on one surface of the fabric material 10133. In some forms, the impermeable material 10131 may be laminated onto the fabric material 10133. In some forms, the impermeable material 10131 and the fabric material 10133 may be selected such that the resulting fabric membrane 10135 exhibits a predetermined overall elasticity or elastic resistance as needed. For example, the addition of the impermeable material 10131 (or membrane layer) may increase the elasticity (or tensile strength) of the fabric material 10133, thereby increasing the tensile strength of the resulting fabric membrane 10135. The impermeable material 10131 may also have low stiffness characteristics so as not to impede the elasticity of the fabric material 10133. In other words, the fabric membrane 10135 will have substantially the same elasticity as the fabric material 10133 alone, so that the addition of the impermeable material 10131 will not substantially reduce the elasticity (or tensile strength) of the fabric material 10133.

[0386] The thickness of the non-breathable material 10131 can be substantially less than the thickness of the fabric material 10133. This helps maintain the relatively lightweight fabric membrane 10135, as the relatively small thickness of the non-breathable material 10131 may not significantly increase the weight of the fabric material 10133. A patient interface with a fabric membrane 10135 including the non-breathable material 10131 will not feel significantly heavier than a patient interface including only the fabric material 10133.

[0387] In some examples, the thickness of the fabric film 10135 is between approximately 0.25 mm and approximately 0.55 mm. In some examples, the thickness of the fabric film 10135 is between approximately 0.30 mm and approximately 0.50 mm. In some examples, the thickness of the fabric film 10135 is between approximately 0.35 mm and approximately 0.45 mm. In some examples, the thickness of the fabric film 10135 is approximately 0.40 mm.

[0388] In some examples, the thickness of the air-impermeable membrane 10131 is between approximately 0.01 mm and approximately 0.10 mm. In some examples, the thickness of the air-impermeable membrane 10131 is between approximately 0.02 mm and approximately 0.08 mm. In some examples, the thickness of the air-impermeable membrane 10131 is between approximately 0.03 mm and approximately 0.07 mm. In some examples, the thickness of the air-impermeable membrane 10131 is between approximately 0.04 mm and approximately 0.06 mm. In some examples, the thickness of the air-impermeable membrane 10131 is approximately 0.05 mm.

[0389] In some forms, the fabric material 10133 can be formed as a multi-layered fabric. In other words, multiple pieces of fabric can be combined together to form the entire fabric material 10133. For example... Figure 40-1As shown, the fabric material 10133 can consist of three layers (although any number of layers can be used). The second layer 10133b of the fabric material 10133 can be sandwiched between the first layer 10133a and the third layer 10133c. In the example shown, the second layer 10133b (i.e., the middle layer) is made of spandex, and the first layer 10133a and the third layer 10133c (i.e., the inner and outer layers) are made of nylon. However, other materials may be used without departing from the scope and spirit of these forms. Furthermore, the first layer 10133a and the third layer 10133c can be formed from different materials (i.e., not the same materials).

[0390] In some forms, the overall composition of fabric material 10133 may be at least 50% nylon and at most 50% spandex. In some forms, the overall composition of fabric material 10133 may be between approximately 60% and approximately 90% nylon and between approximately 10% and approximately 40% spandex. In some forms, the overall composition of fabric material 10133 may be between approximately 70% and approximately 85% nylon and between approximately 15% and approximately 30% spandex. In some forms, the overall composition of fabric material 10133 may be approximately 82% nylon and approximately 18% spandex (e.g., JCD4018 manufactured by WeiMei Textiles Co., Ltd.).

[0391] In some forms, the layered structure can provide a sponge-like feel to the fabric material 10133. In other words, the fabric material 10133 can be supple and deformable upon contact with the patient's face. Specifically, the thickness of the fabric material 10133 can decrease when force is applied, and can return to its original shape when the force is removed. Thus, the fabric material 10133 can function like a sponge because it can at least partially absorb the applied force. Specifically, the spandex layer 10133b of the fabric material 10133 can provide a sponge-like feel (e.g., due to its elastic properties). The sponge-like feel of the fabric material 10133 can help improve comfort to the patient's skin (e.g., because the fabric material 10133 can conform to various facial contours). The sponge-like feel of the fabric material 10133 can also help improve the seal on the patient's face. Specifically, due to the applied force (e.g., via positioning and stabilizing structure 3300), the fabric material 10133 may be able to deform into a slit on the patient's face (e.g., the area between the nostrils and nasolabial folds) without wrinkling and creating a location where air could leak. This helps the patient establish a seal between their skin and the fabric membrane 10135 without requiring the fabric membrane 10135 to contact the exact same location (e.g., this makes wearing the seal-forming structure 3100 easier). This also allows the seal-forming structures 3100, 6100, 9100 to move and / or shift as they wear without causing leakage, as their sponge-like properties help maintain the necessary contact with the patient's skin.

[0392] In some forms, the fabric material 10133 is coated (e.g., laminated) with an impermeable layer 10131 (e.g., liquid silicone rubber) to form a fabric membrane 10135 with impermeable properties. In the example shown, the impermeable layer 10131 is applied to one side of the fabric material 10133. In other words, the impermeable layer 10131 may be applied to a first layer 10133a, rather than to a second layer 10133b or a third layer 10133c. When the fabric membrane 10135 is configured to form sealing structures 3100, 6100, 9100, the first layer 10133a is configured to be located within cavities 3101, 6001, 9001, such that the third layer 10133c is configured to face and contact the patient.

[0393] In one form, the fabric material 10133 is formed of a finely knitted fabric. Specifically, the first layer 10133a and the third layer 10133c are constructed to be finely knitted. This may be a fabric with a denier of less than approximately 100. This may be a fabric with a denier of less than approximately 50. This may be a fabric with a denier of approximately 20. The fine knitting of the fabric, particularly in the third layer 10133c, provides a smooth feel to the patient's skin, which can promote patient compliance (e.g., due to increased comfort). The fine knitting of the fabric also prevents the impermeable layer 10131 from seeping through the fabric layer 10133 (e.g., during the manufacturing process). For example, the fine knitting of the first layer 10133a can limit all seepage, or can allow some seepage but can substantially limit seepage into the other layers 10133b, 10133c. In other words, the first layer 10133a acts as a barrier and substantially restricts the contact and / or coating of the impermeable layer 10131 with the second layer 10133b or the third layer 10133c. Since the first layer 10133a does not come into contact with the patient, some seepage can be allowed because the relative stiffness of the first layer 10133a is less important to patient comfort than the relative stiffness of the third layer 10133c (which directly contacts the patient's skin). Therefore, the spandex will not lose its elasticity due to contact with the impermeable layer 10131. Additionally, the third layer 10133c may not lose its smooth texture due to impregnation with the impermeable layer 10131. Furthermore, since only one surface of the fabric material 10133 needs to be coated with the impermeable material 10131 (i.e., to make the fabric membrane 10135 impermeable), the impermeable membrane 10135 can be constructed to substantially not restrict patient comfort.

[0394] In some embodiments, coating the fabric material 10133 with an impermeable material does not substantially affect the material properties of the fabric membrane 10133. For example, since the impermeable material 10131 is substantially prevented from reaching the second layer 10133b, the spandex forming the second layer 10133b does not significantly reduce its elasticity. This allows the fabric membrane 10135 to continue to stretch generally due to the applied force. Additionally, if the third layer 10133c is impregnated with the impermeable layer 10131, it may lose its drape and become stiff. This could reduce the ability of the third layer 10133c to seal the patient's face. Therefore, in addition to comfort, isolating the impermeable layer 10131 from the third layer 10133c also allows the third layer 10133c to remain substantially relaxed and to seal the patient's face.

[0395] In some embodiments, the air-impermeable layer 10131 includes a thickness T of no more than approximately 500 micrometers. I1 In some embodiments, the airtight layer 10131 includes a thickness T between approximately 4 micrometers and approximately 400 micrometers. I1In some embodiments, the airtight layer 10131 includes a thickness T between approximately 8 micrometers and approximately 300 micrometers. I1 In some embodiments, the airtight layer 10131 includes a thickness T between approximately 12 micrometers and approximately 200 micrometers. I1 In some embodiments, the airtight layer 10131 includes a thickness T between approximately 16 micrometers and approximately 100 micrometers. I1 In some embodiments, the airtight layer 10131 includes a thickness T between approximately 20 micrometers and approximately 70 micrometers. I1 In some embodiments, the airtight layer 10131 comprises a thickness T of approximately 40 micrometers. I1 .

[0396] In some embodiments, the actual thickness T of the air-impermeable layer 10131 in the fabric membrane 10135 is... I2 It can be less than the thickness T of the impermeable layer 10131 before it is coated onto the fabric material 10133. I1 (Although this is not always the case). In other words, if the impermeable material 10131 permeates into the first layer 10133a, then the thickness T of the impermeable layer 10131 will be... I1 The thickness of the first layer 10133a partially overlaps with that of the second layer 10133a, such that the thickness T measured from the outer surface of the first layer 10133a (i.e., the surface facing the cavity) to the exposed surface of the impermeable layer 10131 (i.e., the surface facing the cavity) is equal to the thickness of the third layer 10133a. I2 The total thickness T is less than 10131 of the impermeable layer. I1 .

[0397] Even with a non-breathable layer thickness of 10131 T I2 The density remains substantially the same, even at a lower level (e.g., due to seepage). In some embodiments, the impermeable layer 10131 has a density of no more than about 500 grams per square meter (GSM). In some embodiments, the impermeable layer 10131 has a density between about 5 GSM and about 400 GSM. In some embodiments, the impermeable layer 10131 has a density between about 50 GSM and about 300 GSM. In some embodiments, the impermeable layer 10131 has a density between about 100 GSM and about 200 GSM. In some embodiments, the impermeable layer 10131 has a density between about 110 GSM and about 130 GSM. In some embodiments, the impermeable layer 10131 has a density of about 120 GSM.

[0398] The fabric membrane 10135 offers several advantages by maintaining the separation between the impermeable layer 10131 and the second layer 10133b (i.e., the intermediate layer) and the third layer 10133c (i.e., the patient contact layer). As described above, to achieve the impermeable membrane 10135, the material properties of the fabric material 10133 are not substantially sacrificed. In particular, the third layer 10133 maintains a smooth surface texture to provide patient comfort, while the second layer 10133b retains virtually no loss of its elasticity. The first layer 10133a, the third layer 10133c, and the impermeable layer 10131 can also be elastic, allowing them to stretch together with the second layer 10133b. Specifically, the impermeable layer can have a low stiffness (e.g., between approximately 20 and approximately 40), which provides it with greater tensile strength compared to the more stiff impermeable layer 10131 (e.g., it does not substantially restrict the tensile capacity of the fabric material 10133).

[0399] In other examples, the fabric membrane 10135 is composed entirely of fabric material 10133. Fabric material 10133 may include airtight threads that impart impermeability to the fabric membrane 10135. No additional airtight material layer 10131 is required, which allows the fabric membrane 10135 to be thinner (i.e., only the thickness of the fabric material). The airtight threads may have similar elasticity to non-airtight threads, so that the fabric membrane 10135 with airtight threads does not lose its stretchability.

[0400] In some forms, the fabric membrane 10135 can exhibit a low spring constant (i.e., high compliance) in both the warp and weft yarns. In such forms, unlike conventional designs where a fixing pad may result in a skin torque of 1300° on the patient's face to form an effective seal, the fabric material 10133 and / or the resulting fabric membrane 10135 can have a material spring constant and spring length that makes the fabric membrane 10135 more compliant with the patient's skin than the fabric membrane 10135 is attached to. This can advantageously improve the comfort of the mask and reduce the formation of localized pressure "hot spots," or locations that may cause irritation due to contact with the seal-forming structures 3100, 6100, 9100.

[0401] In some forms, the surface of the fabric material 10133 that contacts the patient's face 1300 may have low-friction properties. This can advantageously improve the comfort of the surface texture of the fabric membrane 10135 and reduce friction relative to the patient's face 1300. The fabric material 10133 may have a surface (e.g., a herringbone pattern) with a first coefficient of friction in a first direction that is different from (e.g., greater than or less than) the coefficient of friction in a second direction. Conversely, during use, a fabric with higher friction may cause the fabric membrane 10135 to grip or rub against the contact area of ​​the patient's face. Such friction or gripping may cause the fabric membrane 10135 to twist or deform, thereby reducing the effectiveness of the seal and allowing undesirable air leakage from the device.

[0402] 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 size and / or shape range. For example, the system may include one form of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, while another form of sealing formation structure is suitable for small-sized heads but not for large-sized heads.

[0403] It should be noted that although the specification may refer to (e.g., by reference characters) a particular illustrated example or a feature of a particular illustrated example (e.g., sealing formation 3100), such discussion may apply to other examples and / or features (e.g., sealing formations 6100, 9100).

[0404] 5.3.1.1 Sealing Mechanism

[0405] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure within the inflation chamber 3200, which acts on its underside to induce a tight seal between the sealing flange and the face. The pressure-assisted mechanism can act in conjunction with elastic tension in the positioning and stabilizing structure.

[0406] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends for at least a portion of the path around the circumference. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from bending during use.

[0407] In one form, a fabric membrane 3130 (e.g., comprising nylon, polyester, nylon and polyester blends, microfibers, or polyurethane) serves as the facial contact portion of the seal-forming structure 3100 of the CPAP mask. The fabric membrane 3130 can be biocompatible and can provide a generally smooth and comfortable surface for the patient, which can improve patient compliance (e.g., because they are not wearing an irritating device). The fabric membrane 3130 can have properties that allow it to stretch in at least one dimension. Before use, the fabric membrane 3130 can be permanently attached (e.g., molded) as a removable module or attached to a support structure (e.g., a flexible support structure 3120).

[0408] In one form, the fabric membrane 3130 can be formed into a complex, predetermined three-dimensional shape such that the fabric is not stretched (e.g., loose, relaxed, and / or wrinkled) before and / or during use, but without substantial leakage causing wrinkles. When attached to the support structure 3120, the fabric membrane 3130 may include one or more curvatures, which can help conform to various contours of the patient's face. Before the patient's face (e.g., nose) approaches and presses against the fabric membrane 3130, the fabric membrane 3130 is adapted to form a constant surface without interruption, such as wrinkles, creases, or folds. In some forms, this can be achieved by molding the fabric membrane 3130 so that it is substantially free of any leakage causing wrinkles. This can help ensure that the fabric membrane 3130 forms a smooth and continuous seal on and around the patient's face. This can provide improved respiratory pressure therapy by reducing the occurrence of folded or wrinkled portions of the seal-forming structure 3100 through which therapeutic air can leak.

[0409] In some forms, areas of the fabric membrane 3130 may be pre-tensioned (e.g., taut before contact with the patient's face) and slightly stretched, while other areas of the fabric membrane 3130 may remain relaxed. In other words, the entire fabric membrane 3130 may not be pre-tensioned. A fabric membrane 3130 with varying tensions can advantageously improve sealing efficiency while reducing pressure on areas protruding further into or towards the cavity 3101 (i.e., "hot spots") in facial anthropometric measurements. In some examples, the sides of the nose region (e.g., sides 3250 and / or corner regions 3252) may remain untensioned and / or relaxed before use to provide additional material to accommodate the facial contours of these sensitive facial areas. In some examples, the bridging portion 3104 may extend between the two nostril openings 3102 and may be tensioned, e.g. Figures 12 to 21As shown. The tension applied to the bridging portion 3104 allows the fabric membrane 3130 to include a complex shape (e.g., multiple curvatures) in one possible way to better conform to the patient's facial contours, while including significantly less tension in the rest of the fabric membrane 3130 (e.g., compared to the bridging portion 3104). In some arrangements, a wide, untensioned fabric membrane 3130 may be more comfortable because the untensioned fabric may apply less pressure to the patient's face.

[0410] By continuously keeping the fabric membrane 3130 wrinkle-free before and during use, the fabric membrane 3130 can conform to the patient's facial contours while minimizing wrinkles and / or blowouts in the seal-forming structure. In some forms, this can also improve seal performance by maximizing the contact area of ​​the fabric membrane 3130 on the patient's face. In some forms, this can also improve the performance of the CPAP device when it is subjected to external lateral or longitudinal forces (e.g., tube resistance).

[0411] In some configurations, when the air chamber 3200 is pulled a short distance away from the patient's face, the applied load of air pressure from within the air chamber 3200 can help maintain an effective seal on the fabric membrane 3130. The applied load of air pressure may be sufficient to cause the fabric membrane 3130 to stretch elastically in at least one dimension, creating a balloon-like "hovercraft" effect on the anthropometric contour of the patient's face 1300, thus maintaining an effective seal thereon.

[0412] In some forms, the fabric membrane 3130 can be held under tension by a relatively rigid support structure 3120. In various forms, the support structure 3120 can be formed of any material, such as silicone, PU foam, PU solid material, or other suitable materials. Although the support structure 3120 is rigider than the fabric membrane 3130, it can still be described as flexible and may bend or flex due to applied tension. In some forms, the support structure 3120 can be relatively less rigid than the shell or frame of the air chamber 3200 (e.g., made of rigid plastic). In other forms, the air chamber 3200 does not include a shell or frame and is entirely composed of the fabric membrane 3130 and the support structure 3120.

[0413] In some forms, the magnitude of the tensile stress can be varied as needed across the fabric membrane 3130 of the entire sealing structure 3100. The bridging portion 3104 can remain taut, and the remainder of the fabric membrane 3130 can be understood as unstretched compared to the bridging portion 3104. The bridging portion 3104 is shown as being in the central portion of the fabric membrane 3130. However, the bridging portion 3104 (or any similar feature that selectively applies tension) can be located anywhere on the entire fabric membrane 3130. Different locations on the fabric membrane 3130 can, however, include varying degrees of tension (i.e., all less than that of the bridging portion 3104). For example, stress concentration areas may exist near one or more openings in the fabric membrane 3130 (e.g., a nasal opening 3102) (through which treatment is performed) or in wider stretches of material. In some examples, in addition to the bridging portion 3104 (which may include the highest tension), the area of ​​the fabric membrane 3130 directly connected to the support structure 3120 (e.g., the outer periphery) may maintain a greater tension than the radial interior of the fabric membrane 3130.

[0414] In some forms, the sealing formation 3100 can utilize a number of different pad configurations, including a single air-assisted fabric membrane 3130, a dual air-assisted fabric membrane 3130, a fabric membrane 3130 with a compression support, or a fabric membrane 3130 with a TPU / TPE / Si support. In some forms, the pad configuration of the sealing formation 3100 can be configured to advantageously provide a "universal size" solution.

[0415] In the example, the sealing structure 3100 and the inflation chamber 3200 can be applied to nose pads, nose supports, mouth and nose pads, ultra-compact full-face masks, full-face masks and other suitable pad arrangements.

[0416] In some forms, the fabric membrane 3130 can be configured to create an effective seal against the subnasal point of the patient's nose, such that the fabric membrane 3130 does not engage with the nasal protuberance, for example... Figure 23 As shown in the diagram. In some forms, the fabric membrane can be configured to create an effective seal at the patient's nasal protuberance (not shown).

[0417] In some forms, the air pressure within cavity 3101 can load the inner surface of the fabric membrane (e.g., the airtight layer 10131) to create further tensile stress, such that the fabric membrane 3130 substantially fills the concave contour of the patient's face 1300 (e.g., around the nostrils, adjacent to the nostril edges). In some forms, the elasticity of the fabric membrane 3130, combined with the load applied by the internal air pressure, can elastically stretch the fabric membrane 3130, thus creating a larger sealing contact area on the patient's face. In some forms, this may also be beneficial in providing a continuous seal even if the mask is removed from its optimal contact point with the patient's face, because the fabric membrane 3130 may partially expand due to the reaction force generated by the internal air pressure (i.e., the "hovercraft effect").

[0418] In some forms, such as in Figures 19 to 21 In the forms shown in 37 to 39, the fabric membranes 3130, 9130 may have one or more gripping pads 3150, 9150 disposed thereon. In one example, the gripping pads 3150, 9150 may be configured to be substantially flat along the patient-facing surface of the fabric membranes 3130, 9130. In other examples, the gripping pads 3150, 9150 may be embossed such that the gripping pads 3150, 9150 may form beads or edges that slightly protrude above the surface of the fabric membranes 3130, 9130. In some forms, the gripping pads 3150, 9150 may have a high coefficient of friction. In some forms, the gripping pads 3150, 9150 may have a defined shape (e.g., oval, see [reference]). Figure 19 , 21 (37 and 39), round, square, etc.). In some forms, the gripping pads 3150 and 9150 can be elongated (see...). Figure 19 and 37 In some forms, the gripping pads 3150 and 9150 may be linear. In some forms, the gripping pads 3150 and 9150 may be arranged in a pattern on the surface of the sealing structures 3100 and 9100. In some forms, the gripping pads 3150 and 9150 may be arranged sporadically on the surface of the sealing structures 3100 and 9100 (see [link to documentation]). Figure 21 and 39 In some forms, gripping pads 3150, 9150 can be arranged to form a periphery near the outer edge of fabric films 3130, 9130 (see [reference]). Figure 19 , 20 37 and 38). In some forms, the gripping pads 3150 and 9150 forming the perimeter can be in the form of dashed lines (see...). Figure 19 and 37 In some forms, the gripping pads 3150 and 9150 forming the perimeter can be in the form of solid lines (see [reference]). Figure 20 and 38 In some forms, the gripping pads 3150, 9150 forming the periphery may be in the form of multiple lines, dotted lines, or solid lines, or combinations thereof. In some forms, the gripping pads 3150, 9150 may assist the fabric membrane 3130, 9130 in gripping the patient's face. In one example, the gripping pads 3150, 9150 are formed as a relatively thin silicone layer applied to the surface of the fabric membrane 3130, 9130. In any of the above configurations, the gripping pads 3150, 9150 may provide other materials (e.g., fabric and silicone) that come into contact with the patient's face. While it may not provide the comfort that an entire fabric surface can offer (e.g., only where the fabric material of the fabric membrane contacts the patient's nose), the gripping pads 3150, 9150 included on the fabric membrane 3130, 9130 may provide benefits in helping to ensure that the sealing formation 3100, 9100 remains in place (e.g., to transmit therapeutic pressure to the patient). In addition, having only a small area covered with silicone (or other gripping material) may be more comfortable for patients than having the entire seal formed by silicone (or other similar materials) compared to a relatively large area of ​​fabric (or all of it).

[0419] In some forms, the fabric membrane 3130 can be integral with the support structure 3120 by attaching (e.g., molding) the outer edge (e.g., outer periphery) of the fabric membrane 3130 to the support structure 3120 via a lip around the curved edge (i.e., inner edge) of the support structure 3120. In one example, the fabric membrane 3130 is attached to provide the front of the seal-forming structure 3100. The fabric membrane 3130 also extends in a forward direction such that the fabric membrane 3130 is curved away from the front. In other words, the fabric membrane 3130 is curved to extend beyond the front and provide additional surface area of ​​fabric material exposed to the patient. This arrangement may be advantageous because virtually all of the patient's face in contact with the seal-forming structure 3100 is in contact with the fabric membrane 3130. This may be beneficial for improving patient compliance, as contact with the fabric membrane 3130 can be more comfortable. For the patient, therefore, a patient is more likely to wear a patient interface 3000 incorporating the fabric membrane 3130 compared to a patient interface 3000 that includes at least some other material (e.g., silicone) in the facial contact area.

[0420] In one example, the fabric membrane 3130 is attached to the support structure 3120 via a specific process (described later), which may form a curved portion without creating creases, wrinkles, folds, or bends on the surface of the fabric membrane 3130. It can be seen that in some examples, at the transition portion 36, both the support structure 3120 and the fabric membrane 3130 can have radii of curvature (e.g., the same or similar radii of curvature) along curve 35 in a direction from the front side of the sealing forming structure 3100 to the rear side of the sealing forming structure (see...). Figures 16 to 18 The fabric membrane 3130 may have a predetermined curvature, such that the portion of the fabric membrane 3130 not directly supported by the support structure 3120 extends along curve 35. Figures 16 to 18 The fabric membrane 3130 can be held slightly taut against the support structure 3120, but the fabric membrane 3130 that is not directly supported by the support structure 3120 (e.g., not in direct contact with it) can be considered substantially relaxed (e.g., less tension than that borne by the bridging portion 3104). This can help form a dome shape (e.g., a convex dome) in certain areas of the fabric membrane 3130 (e.g., the sides 3250 and / or the corner regions 3252), which can help the fabric membrane 3130 seal against the contours of the patient's face (e.g., the subnasal point of the patient's face (i.e., the corner of the nasal region (i.e., the area where the nasal ala terminates near the upper lip near the nasolabial fold))). Figure 12 As shown. The dome shape helps prevent wrinkles, creases, folds, and bends in the fabric membrane 3130, which helps avoid the formation of leakage paths. Similarly, the dome shape helps the fabric membrane 3130 enter difficult-to-seal areas of the patient's face, such as the corners of the nasal region. The fabric membrane 3130 may have a saddle shape at the mid-nasal subnasal point region 3260, which is configured to seal against the patient's subnasal point, thereby matching the saddle shape formed by the patient's nasolabial angle and upper lip, as... Figure 12 As shown. Similarly, the nasal acupoint region 3270 may also have a saddle shape, which is configured to seal against or below the matching contour presented at or below the patient's nasal acupoint. In the direction of curve 35, the curvature (e.g., the magnitude and / or radius of curvature) of the fabric membrane 3130 may vary along the outer periphery of the fabric membrane 3130 in different regions of the pad assembly. For example, as Figure 16 As shown, the fabric membrane 3130 in the intermediate nasal protrusion region 3270 may have a different curvature in the direction of curve 35 than the fabric membrane 3130 in the intermediate subnasal protrusion region 3260. In one example, the curvature (e.g., the magnitude and / or radius of curvature) at the side 3250 of the fabric membrane 3130 may differ from the curvature of the intermediate nasal protrusion region 3270 and / or the intermediate subnasal protrusion region 3260.

[0421] In some forms, the fabric membrane 3130 may be slightly inclined inward or curved inward toward the inside of the mask (e.g., a positive arch curvature in the left-right direction), such as... Figures 12 to 21 As shown. In some forms, the fabric membrane 3130 can be formed into a dome shape above the support structure 3120, for example, as Figures 26 to 33 As shown. Note that any pad assembly 6105, 9105 disclosed herein may have a fabric membrane 6130, 9130 attached to the outer edge of the support structure 6120, 9120, such that the fabric membrane 6130, 9130 forms part of a sealing structure 6100, 9100, as referenced above. Figure 12 As discussed, the fabric membrane 6130 extends along curve 35 from the front side of the sealing structure to the rear contact surface, such that the fabric membrane 6130 of, for example, the pad assembly 6105 can be formed to a greater extent with a negative curvature from one side to the other. In other words, because the fabric membrane 6130 is attached to the support structure 6120 with curvatures in different directions and / or about different axes, the fabric membrane 6130 can be formed to have an inwardly curved and dome shape. In one example, most of the fabric membrane 6130 includes a positive (e.g., inward) curvature that can support a portion of the patient's face, and only the periphery (e.g., the area near the support structure) is dome-shaped (e.g., includes a negative curvature).

[0422] In some forms, the central portion of the fabric membrane 3130 has a saddle shape. In other words, the periphery of the fabric membrane 3130 can be shaped to have a negative arch curvature (e.g., relative to the patient's face in use), and the central portion includes a positive arch curvature (e.g., around the bridging portion 3104), so the central portion (e.g., near the bridging portion 3104) can be regarded as a point of minimum and maximum (e.g., relative to the patient's face in use), and thus can be regarded as a saddle.

[0423] In some forms, if the fabric membrane 3130 is not subjected to continuous tension (before and / or during use) or is not elastic, the fabric membrane 3130 can form an improved air-assisted seal on the patient's face, thereby dynamically conforming to changes / movements caused by the fabric membrane 3130 being thinner than the support structure 3120 (e.g., a silicone membrane) and having lower structural stiffness (e.g., "hovercraft effect").

[0424] In some forms, the fabric membrane 3130 can be supported by a second or third support structure that can be used as a pad support. The pad support provides additional flexibility and can be adapted for most patient faces (universal sizes). The second or third support layer can be formed using fabric membranes, fabrics with PU / Si films, laminated open-cell foams, laminated PU foams, PU molding, TPU / TPE, or silicone. In some forms, the additional support layer itself can be supported by structural / rigid plastics such as PP / PC / PA / PET or other suitable materials.

[0425] In some forms, 3D printing fabric membranes and / or pad supports as a “skeleton” can reduce thickness and thus lighten the weight of the mask.

[0426] In some forms, multiple different layers of the mask can be printed with varying rigidity, hardness, or thickness. For example, the "skeleton" portion can be formed using Si, PU foam, PU solid material, or any suitable plastic material.

[0427] In one embodiment, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or gasket seal portion is constructed and arranged to be compressed, for example, due to elastic tension in the positioning and stabilizing structure.

[0428] In one form, the sealing structure includes a tensioning portion. The tensioning portion can be located at any number of discrete positions throughout the sealing structure. In use, the tensioning portion is held taut, for example, by adjacent areas of the sealing flange.

[0429] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0430] 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.

[0431] 5.3.1.2 Nasal columella or bridge area

[0432] In one embodiment, the non-invasive patient interface 3000 includes a sealing structure that forms a seal on the nasal columella region or bridge region of the patient's face during use.

[0433] In one form, the sealing structure includes a saddle-shaped region configured to form a seal on the nasal columella or bridge of the patient's face during use.

[0434] 5.3.1.3 Upper lip region

[0435] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that, upon use, forms a seal on the upper lip region (i.e., the upper part of the lip) of the patient's face.

[0436] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip region of the patient's face during use.

[0437] 5.3.1.4 Chin area

[0438] 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.

[0439] In one form, the sealing structure includes a saddle-shaped region configured to form a seal on the chin area of ​​the patient's face during use.

[0440] 5.3.1.5 Forehead area

[0441] 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.

[0442] 5.3.1.6 Nasal pillow

[0443] In one embodiment, the sealing portion of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is configured and arranged to form a seal with the corresponding nostril of the patient's nose.

[0444] A nasal pillow according to one aspect of the present invention includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Additionally, the nasal pillow connection structure of the present invention includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of the truncated cone and the nasal pillow connection structure in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the structure connected to the handle.

[0445] 5.3.2 Nose pad

[0446] refer to Figures 6 to 21 The image shows a patient interface 3000 with a pad assembly 3105 according to a first example of the present technology, the pad assembly 3105 including a sealing formation structure 3100 and an inflation chamber 3200.

[0447] The example of the sealing structure 3100 described above can be considered as a nasal pad and is designed to provide pressurized airflow to the patient's nostrils by sealing against at least the lower side of the patient's nose. The exemplary sealing structure 3100 may engage the patient's face below the columella, and depending on the size and shape of the patient's nose, some examples may engage the patient's nose below the nasal protuberance. The exemplary sealing structure 3100 may also engage the patient's face at least above the vermilion border of the upper lip. Thus, the exemplary sealing structure 3100 can seal against the upper part of the patient's lips during use. Furthermore, the patient's mouth may remain uncovered by the illustrated example of the sealing structure 3100, allowing the patient to breathe freely, i.e., directly into the atmosphere without interference from the sealing structure 3100. The subnasal pads may be configured such that they do not have openings sized to accommodate the patient's nose within a cavity. Furthermore, the height of the pad 3105 from the lower edge of the fabric membrane at the central nasal subpoint region to the upper edge of the fabric membrane 3130 at the central nasal protrusion region can be less than the width of the pad 3105 in the left-right direction from one side edge of the fabric membrane 3130 to the other side edge of the fabric membrane 3130 (for example, see...). Figure 12 ).

[0448] Examples of nasal pad 3105 (e.g., the exemplary seal-forming structure 3100 disclosed herein) may include an upper saddle-shaped or concave region with positive curvature across the entire pad. Furthermore, nasal pad 3105 can be understood as having a single targeted seal-forming region or surface, while a nasal pillow pad may have two targeted seal-forming regions (one for each nostril). Nasal pad 3105 may also have a posterior wall that contacts the upper part of the patient's lips and an upper central surface that contacts the lower side of the patient's nose (e.g., the patient's subnasal point and / or columella). A nasolabial fold angle may be formed between these two surfaces of the patient's face (see...). Figure 2E The nose pad 3105 can be shaped to have a nasolabial angle in the range of 90 to 120 degrees.

[0449] Furthermore, the exemplary sealing structure 3100 can also be shaped and sized such that during use, no part of the sealing structure 3100 substantially does not enter the patient's nostril. In other words, a portion of the sealing structure 3100 may contact the flange in certain directions and extend slightly inside, but the sealing structure 3100 does not substantially seal within the nasal passage (e.g., as opposed to a nasal pillow-type mask).

[0450] 5.3.2.1 Inflation Chamber

[0451] refer to Figures 6 to 12The inflation chamber 3200 has a periphery that, in use, forms a sealed area shaped to complement the surface contours of a normal person's face. In use, the edges of the inflation chamber 3200 are positioned very close to the adjacent surface of the face. The sealing formation 3100 provides actual contact with the face. The sealing formation 3100 can extend around any portion of the periphery of the inflation chamber 3200 during use (e.g., around the entire periphery, around most of the periphery, etc.).

[0452] In some forms of this technology, the air chamber 3200 may be made of a flexible material (e.g., silicone) and may be formed as a one-piece structure with a support structure 3120 (e.g., formed of any material suitable for the support structure 3120 and / or the air chamber 3200 as described herein). In some examples, the sealing formation structure 3100 may be an extension of or formed as part of the air chamber 3200, such that the air chamber 3200 surrounds the sealing formation structure 3100. In such examples, the support structure 3120 and the fabric membrane 3130 may be considered as part of the air chamber 3200 (e.g., the sealing formation structure 3100 at least partially forms the internal volume of the air chamber 3200). In some examples, the air chamber 3200 may be made of a transparent material (e.g., transparent silicone). The use of transparent materials can reduce obstruction of the patient interface 3000 and help improve treatment adherence. The use of transparent materials can help clinicians (or patients) observe how the patient interface is positioned and functions (e.g., to ensure a proper seal) and the cleanliness of the patient interface 3000. Transparent materials allow clinicians or patients to observe the accumulation of debris (e.g., dust, mold, etc.) within the inflation chamber 3200, enabling the patient interface 3000 to be cleaned or replaced. This provides a sense of cleanliness to the patient when wearing the patient interface and helps ensure that the patient does not inhale harmful substances. Both of these contribute to improved treatment adherence. Alternatively, or in addition to transparent materials, translucent materials can be used, which can provide similar benefits to the patient. Optionally, the inflation chamber 3200 is constructed of a relatively rigid material (e.g., polycarbonate) compared to the seal-forming structure 3100. Rigid materials can also be made of transparent and / or translucent materials (e.g., transparent polycarbonate, etc.) to achieve similar benefits to flexible transparent materials (e.g., allowing observation).

[0453] In some forms, the sealing structure 3100 may include an opening connecting an inflation chamber 3200, wherein the sealing structure 3100 is hermetically connected to the inflation chamber 3200. The sealing structure 3100 and the inflation chamber 3200 may at least partially form a cavity 3101 pressurized by an airflow. In the example shown, the sealing structure 3100 and the inflation chamber 3200 together form the cavity 3101. At least one opening in the sealing structure (e.g., a pair of nostril openings 3102) may allow fluid communication between the cavity 3101 and the patient's nostrils. However, the nostril openings 3102 may be small enough to allow the patient's nose (e.g., nasal protuberance) into the cavity 3101.

[0454] The connection between the sealing structure 3100 and the inflation chamber 3200 at the inflation chamber connection opening 3106 can be a permanent bond. Alternatively, the connection between the sealing structure 3100 and the inflation chamber 3200 at the inflation chamber connection opening 3106 can be a chemical bond. The sealing structure 3100 can be connected to the inflation chamber 3200 at the inflation chamber connection opening without a mechanical connection. Optionally, the sealing structure 3100 can be connected to the inflation chamber 3200 at the inflation chamber connection opening via a mechanically removable detachable connection.

[0455] On each side of the inflation chamber 3200, there may be an inflation chamber side end 3202 in the form of a hollow channel, which forms an inflation chamber inlet port, the size and structure of which are designed to receive airflow. An inflation chamber connector 3204 may also be provided on each side of the inflation chamber 3200, laterally outside the inflation chamber side end 3202. The inflation chamber connector 3204 may be connected to a corresponding end 3314 of the positioning and stabilizing structure 3300. The connection between the inflation chamber connector 3204 and the corresponding end 3314 of the positioning and stabilizing structure 3300 may be releasable on both sides. In other examples, one side may have a permanent connection, while the other side may have a releasable connection. In yet another example, both connections between the inflation chamber connector 3204 and the corresponding end 3314 of the positioning and stabilizing structure 3300 may be permanent.

[0456] The side end 3202 of the inflation chamber can receive pressurized airflow from the positioning and stabilization structure 3300 (e.g., a catheter headband). The pressurized airflow can then pass through the inflation chamber 3200, then through the sealing formation structure 3100, and into the patient's airway for inhalation.

[0457] The end 3314 of the positioning and stabilizing structure 3300 (e.g., the opening of a corresponding conduit) can be connected to the lateral end 3202 of the inflation chamber. In these examples, each inflation chamber connector 3204 may include a slot 3209, a chamfered edge 3208, and a notch 3206 that can be removably connected to a clamp of the positioning and stabilizing structure by a snap-fit ​​engagement.

[0458] 5.3.2.2 Sealing Structure of This Technology

[0459] Each of the sealing structures 3100 may include a support structure 3120 that provides support to the sealing portion 29130 (e.g., a fabric membrane) that creates a seal with the patient’s face. The sealing portion 29130 is configured to sealably engage the patient’s face (e.g., when pressurized air is supplied to the inflation chamber 3200).

[0460] In one example, the sealing forming structure 3100 may include a support structure having at least two regions (e.g., two, three, four, etc.) of different thicknesses (e.g., the sealing forming structure 3100 includes a support structure 3120 with a wall structure, the thickness of which is increased relative to the other portions of the wall structure for its lateral support regions 3122). For example, as Figure 58 and 59 As shown, some portions 3123 of the support structure 3120 may be thicker than other portions 3124, 3126 of the support structure 3120. For example, the thicker portions 3123 may be adjacent to or connected to the air chamber 3200, and portions 3124, 3126 may be adjacent to or connected to the fabric membrane 3130 to provide structural stability at the connection with the air chamber 3200 and flexibility at the interface with the patient. Optionally, a thicker lateral support region 3122 may be located, for example, at the corner of the nasal region of the sealing formation structure (and may be directly connected to the fabric membrane, for example), to ensure adequate sealing in the posterosuperior lateral panel region of the patient's face.

[0461] Furthermore, in the depicted example, each fabric membrane (e.g., a sealing portion) may have two separate nostril openings 3102, each corresponding to one of the patient's nostrils, to provide airflow to both patients' nostrils. A bridging portion 3104 may be located between the nostril openings 3102. The bridging portion 3104 may assist in maintaining the desired shape of the fabric membrane before and / or during use.

[0462] The rigidity of the sealing portion 3130 may be less than that of the support structure 3120, and it may be made of a fabric material such as nylon, polyester, nylon and polyester blends, microfibers, or polyurethane, as will be described in more detail later. The sealing portion 3130 described in any example of this disclosure may be referred to as a fabric sealing portion or a fabric membrane, and may include a fabric material having airtight properties (e.g., laminated, coated, or otherwise applied thereon).

[0463] The support structure 3120 may have a pore formed therein, which provides an inner edge for the support structure 3120. A sealing portion 3130 (e.g., the outer periphery of the sealing portion 3130) may be attached to the support structure 3120 along this inner edge, such that the sealing portion 3130 extends radially inward from the support structure 3120 beyond the support structure or extends to a degree greater than the support structure, for example, as... Figures 12 to 21 As shown. For example, the sealing portion 3130 may be molded around the inner edge of the support structure 3120 or otherwise suitably attached to the support structure 3120, as will be described later.

[0464] refer to Figures 12 to 15 The sealing forming portion 3100 has a wall structure that may include a lateral support region 3122, the thickness of which is increased compared to other portions of the wall structure of the support structure 3120. A lateral support region 3122 may be provided on each of the outermost sides of the sealing forming structure 3100. The sealing forming structure 3100 may include two lateral support regions 3122, each spaced apart distally from the end of a plane bisecting the sealing forming structure 3100, which, in use, will be parallel to the patient's sagittal plane. The lateral support region 3122 may be the thickest portion of the sealing forming structure 3100 to provide resistance to lateral displacement (e.g., caused by the patient sleeping on their side, causing the nasal pillow to push laterally against the sealing forming structure) and to provide a firm engagement with the patient's nasal ala. The lateral support region 3122 may have a thickness of approximately 0.9 mm to approximately 1.5 mm, or approximately 1.3 mm to approximately 1.4 mm, or approximately 1.3 mm, or approximately 1 mm to approximately 1.5 mm. Since the lateral support region 3122 is the thickest region of the sealing structure 3100 in the depicted example, the lateral support region 3122 can also provide the greatest resistance to deformation.

[0465] The fabric membrane 3130 can be formed such that it forms part of a portion of the sealing structure 3100, which curves from the front side of the sealing structure 3100 to the rear facial contact side, as previously described. Specifically, the fabric membrane 3130 contacts the support structure 3120 in the transition portion 36, such that the fabric membrane portion 3130 can be configured to engage the posterosuperior lateral panel region of the patient's face (i.e., the region where the nasal alae terminate near the upper lip close to the nasolabial fold), which is a particularly complex geometric region. The posterosuperior lateral panel region of the patient's face exhibits a particularly complex geometry because at least three facial surfaces (nasal alae, upper lip, and cheek) converge in this region. Therefore, the sealing structure 3100 can be more flexible and compliant (e.g., not taut near the outer periphery of the fabric membrane 3130) to more easily conform to the patient's facial contours.

[0466] As mentioned above, Figures 19 to 21 A gripping pad 3150 is shown on the surface of the fabric membrane 3130.

[0467] 5.3.2.3 Positioning and Stabilizing Structure

[0468] The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by positioning and stabilizing structure 3300.

[0469] In one configuration, the positioning and stabilizing structure 3300 provides a holding force sufficient to overcome the positive pressure in the inflation chamber 3200 to elevate the face away from the face.

[0470] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the effects of gravity on the patient interface.

[0471] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential impact of destructive forces on the patient interface 3000, such as destructive forces caused by tube resistance or accidental interference with the patient interface.

[0472] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilization structure 3300 has a small side or cross-sectional thickness to reduce the sensing or physical volume of the device. In one example, the positioning and stabilization structure 3300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0473] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured not to be too large or bulky to prevent the patient from lying in a supine sleeping position and to place the back area of ​​the patient's head on a pillow.

[0474] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured not to be too large or bulky to prevent the patient from lying in a side-lying sleeping position and to place the side area of ​​the patient's head on the pillow.

[0475] In one form of this technology, the positioning and stabilizing structure 3300 has a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible band or soft strap. The decoupling portion is constructed and arranged such that when a patient rests their head on the pillow, its presence prevents forces at the rear from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0476] 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 one form, the fabric outer layer includes a loop material to engage with a hook material portion.

[0477] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For example, the strap may be configured to be taut during use and to guide forces to seal the sealing structure 3100 into a portion of the patient's face. In one example, the strap may be configured as a tie.

[0478] In one form of the technology, the positioning and stabilizing structure includes a first frenulum that is constructed and arranged such that, in use, at least a portion of its lower edge passes over the top of the patient's ear base and covers a portion of the parietal bone, but not the occipital bone.

[0479] In one form of the technology applicable to nasal masks or full-face masks only, the positioning and stabilizing structure includes a second strap that is constructed and arranged such that, in use, at least a portion of its upper edge passes below the subauricular base of the patient's head and covers or lies below the occipital bone of the patient's head.

[0480] In one form of this technology applicable to nasal masks or full-face masks only, the positioning and stabilizing structure includes a third strap that is constructed and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to move apart from each other.

[0481] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is flexible and, for example, non-rigid. An advantage of this is that the strap makes it more comfortable for the patient to lie on it while sleeping.

[0482] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is configured to be breathable to allow moisture to be transferred through the strap.

[0483] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide a retaining force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, while another form of sealing formation structure suitable for small-sized heads but not for large-sized heads.

[0484] 5.3.2.3.1 Positioning and Stabilization Structure of this Technology

[0485] Figure 6 An example of the present technology is depicted, including a positioning and stabilizing structure 3300. In this example, the positioning and stabilizing structure 3300 includes a transverse portion 3302 and an upper portion 3304 in the form of a conduit, which guides the flow of pressurized gas from the hub 3306 to an end portion 3314. The positioning and stabilizing structure 3300 can be arranged such that, in use, the hub 3306 and the decoupling structure 3500 are positioned above the patient's head. As described below, the decoupling structure 3500 can rotate within the hub 3306, and when the patient wears the patient interface 3000, for example during treatment, the position of the hub 3306 and the decoupling structure 3500 above the patient's head allows the patient more freedom of movement without becoming entangled with the air circuit 4170.

[0486] The positioning and stabilizing structure 3300 can be constructed from silicone resin. For example, the lateral portion 3302, the upper portion 3304, the hub 3306, and the side end 3314 can be constructed or molded from a single piece of silicone resin.

[0487] The upper portion 3304 of the positioning and stabilizing structure 3300 has a ridge and a valley (or a hexagonal cross-section), which allows the upper portion 3304 to conform to the shape of the corresponding part of the patient's head during use. The ridge and valley of the upper portion 3304 allow the upper portion 3304 to extend and contract along the longitudinal axis to accommodate larger or smaller heads. The ridge and valley of the upper portion 3304 allow the upper portion 3304 to bend to different radii of curvature to accommodate patient heads of different shapes and sizes.

[0488] The transverse portion 3302 of the positioning and stabilizing structure 3300 may not form the ridge and valley of the upper portion 3304. Therefore, the elongation and flexibility of the transverse portion 3302 can be smaller than that of the upper portion 3304, which is advantageous because the shape and size of the patient's head side are less variable.

[0489] End 3314 can be connected to the corresponding inflation chamber side end 3202. As described above, the inflation chamber side end 3202 receives pressurized airflow from the positioning and stabilizing structure 3300, which passes through the inflation chamber 3200, through the sealing forming structure 3100, and reaches the patient's airway. As described above, end 3314 can be connected to the inflation chamber connector 3204 of the corresponding inflation chamber side end 3202.

[0490] The positioning and stabilizing structure 3300 can be constructed and arranged to guide the force / tension provided by the transverse portion 3302 into force vectors applied to the portion above and portion behind the inflation chamber 3200. In particular, the portion above and portion behind force vectors push the fabric membrane of the sealing forming structure 3100 into sealing contact with the bottom surface of the patient's nose, for example at or below the nasal protuberance and at least above the vermilion border of the upper lip.

[0491] The transverse portion 3302 may also each include a tab 3308 that receives the rear bandage end 3311 of the rear bandage 3310. The rear bandage 3310 may be length-adjustable, for example, having a hook-and-loop material arrangement, whereby one of the rear bandage end 3311 and the remainder of the rear bandage 3310 includes hook material on its exterior, while the other includes loop material on its exterior. The length adjustability of the rear bandage 3310 allows for increased tension on the transverse portion 3302 to pull the seal-forming structure 3100 into a sealed engagement with the patient's face under the desired pressure (i.e., tight enough to avoid leakage without being too tight to cause discomfort).

[0492] The transverse portion 3302 may also be provided with a sleeve 3312, which rests the patient's face against the transverse portion 3302. The sleeve 3312 may be made of a breathable fabric material with a soft feel. After the end 3314 is removed from the side end 3202 of the inflation chamber, the sleeve 3312 can be removed from the transverse portion 3302.

[0493] In some forms (for example, see Figure 7The positioning and stabilizing structure 6300 may include a fabric tube 6350 having a left arm 6305 and a right arm 6307. The fabric tube 6350 may be formed with a first side configured to contact the patient. This may be referred to as the inner layer 6352. The fabric tube may also include a second side attached to the inner layer 6352 but facing away from the patient; this second side may be referred to as the outer layer 6354. The inner layer 6352 and the outer layer 6354 may each be secured to each other along their edges, such that a channel (or passageway) is formed between the seam of the inner layer 6352 and the outer layer 6354. That is, the space between the seams remains unattached and forms an air passage 6372. The inner layer 6352 and the outer layer 6354 may be joined using various techniques that impart special properties to the seam or joint. For example, in some forms, ultrasonic welding, radio frequency welding, and cutting and welding techniques are used to form the seam. Heat can be applied to specific areas, thereby activating the thermosetting or thermoplastic material used in tube 6350. This heat can be used not only to join the layers together but also to heat and form thermoformed layers, such as the outer layer 6354. Furthermore, in some forms, stitching or adhesives such as glue can be used to join the layers together. In some forms, stitching is not used. In a further form, material beyond the layers is not used to join the inner layer 6352 and outer layer 6354 of the tube. For example, in some forms, the inner layer 6352 and outer layer 6354 can be formed such that additional materials such as glue or stitching are not required to join the inner layer 6352 and outer layer 6354 together.

[0494] Each of the inner layer 6352 and the outer layer 6354 may include an inner surface and an outer surface. The inner surface of the inner layer 6352 is the surface facing the outer layer 6354. The inner surface of the outer layer 6354 is the surface facing the inner layer 6352. Similarly, the outer surface of the outer layer 6354 faces away from the inner layer 6352, while the outer surface of the inner layer 6352 faces away from the outer layer 6354. Furthermore, in the form of a single sheet, the inner surface is the inward-facing surface of the sheet that faces itself.

[0495] In some forms, one or more sheets of the tube may include an airtight layer or membrane. In some forms, the inner surfaces of both layers include a diaphragm configured to restrict or inhibit air transfer through the layer from the inner surface to the outer surface. The airtight layer may be thin, less than the thickness of the inner or outer fabric sheet. In other forms, the impermeable layer may be greater than the thickness of the fabric sheet of either layer. The airtight layer, diaphragm, or membrane may be completely impermeable to air transfer, or may be configured to allow a predetermined rate or amount of air transfer at a specific pressure.

[0496] The diaphragm can be formed from a thermoplastic or thermosetting material, allowing the diaphragm material to be molded or shaped into a specific form when exposed to a specific temperature, and then cured, solidified, or solidified upon cooling. In some forms, the diaphragm can be formed from silicone or polyurethane. In some forms, the outer layer 6354 can be pre-formed such that, in an unpressurized or unsupported state, the outer layer 6354 is pre-positioned and pre-shaped to extend away from the inner layer 6352 between the opposing joints 6312. That is, the outer layer 6354 can support its own weight such that, when not supported by pressurized air or other support mechanisms, the outer layer 6354 remains spaced apart from the inner layer 6352 between the joints 6312.

[0497] In contrast, the inner layer 6352 can be a soft component. The inner layer 6352 can be attached and secured to the edge of the outer layer 6354, such that the inner layer 6352 is a substantially flat layer.

[0498] like Figure 8 As shown, especially Figure 9 As shown, the inner layer 6352 includes a fabric sheet 6360 and a diaphragm 6362. The fabric sheet 6360 may be formed of felt, foam, woven, knitted or nonwoven materials or other fiber networks.

[0499] The outer layer 6354 includes a tube sheet 6364 and an outer covering 6366. In some forms, the tube sheet 6364 may be covered with membranes on both sides. Figure 10 As shown, tube sheet 6364 includes a diaphragm 6368 exposed to the chamber of tube 6350 and a diaphragm 6370 along the opposing surface of tube sheet 6364. Diaphragm 6368 can help provide a seal between inner layer 6352 and outer layer 6354 and form an airtight tube. Diaphragm 6370 can help connect tube sheet 6364 to outer cover 6366.

[0500] 5.3.2.4 Vent

[0501] In one embodiment, the patient interface 3000 includes a ventilation port 3400 that is configured and arranged to allow the expulsion of exhaled gases, such as carbon dioxide.

[0502] In some configurations, the airway 3400 is configured to allow continuous airflow from the inflation chamber 3200 to the environment, while the pressure in the inflation chamber is positive relative to the environment. The airway 3400 is configured such that the airflow rate is sufficient to reduce the rebreathing of exhaled CO2 from the patient, while maintaining the therapeutic pressure in the inflation chamber during use.

[0503] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0504] A vent 3400 may be located within an inflation chamber 3200. As described above, the vent 3400 may include multiple holes. The holes of the vent 3400 may be divided into two laterally spaced groups. The axes of the flow paths through each hole of the vent 3400 may be parallel to avoid crossflow and prevent additional noise. The vent may be circular.

[0505] The radius of the vent 3400 can decrease from the inside to the outside of the inflation chamber 3200. Each vent is provided with a draft angle. The front diameter of each hole is smaller than the rear diameter. The draft angle means that the hole has no small cross-section over the entire chassis thickness, which helps to provide efficient carbon dioxide ejection at high humidity levels. In addition, a larger draft angle makes the inflation chamber 3200 easier to manufacture, especially when the inflation chamber 3200 is formed from injection-molded plastic material. The draft angle allows for the use of relatively thick vent pins in the mold and makes ejection easier.

[0506] The vents 3400 can be arranged in two groups facing the center of the inflation chamber 3200, and these groups can be symmetrical along the center line of the inflation chamber 3200. Providing a pattern of multiple vents can reduce noise and disperse concentrated flow.

[0507] The vent 3400 can be positioned at an optimal distance from the centerline of the air chamber 3200. Orienting the vent 3400 towards the centerline advantageously reduces the chance of vent blockage when the patient is sleeping on their side. However, placing the vent too close to the center of the air chamber 3200 may cause the air chamber 3200 to be excessively weakened at the center, especially since, in the depicted example, the cross-section of the air chamber 3200 is smallest at the center due to the overall shape of the air chamber 3200. The positioning of the vent 3400 avoids vent blockage during side-lying sleep while ensuring sufficient sturdiness in the central portion of the chassis.

[0508] The size and number of each vent can be optimized to achieve a balance between reducing noise and achieving necessary carbon dioxide flushing, even under extreme humidification conditions. In the depicted example, the vent of vent 3400 may not provide the full ventilation to the system. Decoupling structure 3500 may include decoupling structure vent 3402. Decoupling structure vent 3402 may include one or more holes passing through decoupling structure 3500. Decoupling structure vent 3402 can be used to expel excessive pressure generated by RPT device 4000 before it reaches the patient, while vent 3400 can be used to flush out carbon dioxide exhaled by the patient during treatment.

[0509] In some examples, a ventilator insert (not shown) is removably or permanently attached to the inflation chamber 3200 at the ventilator insert opening. This ventilator insert may be made of a more flexible material than the material of the inflation chamber 3200. In one example, a heat and moisture exchange (HME) material (e.g., foam) is housed in a removable ventilator to humidify the air inhaled by the patient, eliminating the need for a separate humidifier. The ventilator insert may be removable to allow the patient to replace the HME material with a fresh, clean sheet of HME material after a certain period of time. Alternatively, the entire ventilator structure may be replaceable (e.g., unlike the individual HME material).

[0510] 5.3.2.5 Decoupling Structure

[0511] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball head and a ball socket.

[0512] As described above, hub 3306 is connected to decoupling structure 3500, which in these examples is a rotatable bend. In use, decoupling structure 3500 can rotate 360° within hub 3306. Decoupling structure 3500 can be removed from hub 3306 by manually pressing button 3504 to release a clip (not shown) from within hub 3306.

[0513] The decoupling structure 3500 may also include a rotating shaft 3502, which allows for rotatable connection to the air circuit 4170.

[0514] The rotatability of the decoupling structure 3500, the form of the decoupling structure 3500 as a bent tube, and the rotatability of the rotating shaft 3502 on the decoupling structure 3500 all increase the degree of freedom, thereby reducing the resistance and torque of the tube on the patient interface 3000 caused by the connection with the air circuit 4170.

[0515] 5.3.2.6 Connection Port

[0516] Connection port 3600 allows connection to air circuit 4170.

[0517] 5.3.2.7 Forehead stent

[0518] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0519] 5.3.2.8 Anti-suffocation valve

[0520] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0521] Port 5.3.2.9

[0522] 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 one embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0523] 5.3.3 Full-face mat

[0524] refer to Figures 26 to 33 The patient interface 6000 includes a pad assembly 6105 having a sealing formation structure 6100 configured to seal around the patient's nostrils and mouth, respectively (e.g., a mouth-nose pad assembly or an ultra-compact full-face mask). According to an example of the present technology, the pad assembly 6105 is at least partially formed by an inflation chamber 6200 and the sealing formation structure 6100 attached to the inflation chamber.

[0525] refer to Figures 22 to 25 Images 34 to 39 show a pad assembly 9105. Pad assembly 9105 is similar to pad assembly 6105 and has a sealing formation structure 9100 configured to seal around a patient's nostrils and mouth (e.g., a mouth-nose pad assembly or an ultra-compact full-face mask). According to an example of the present technology, pad assembly 9105 is at least partially formed by an inflation chamber 9200 and a sealing formation structure 9100 attached to the inflation chamber.

[0526] Mat assembly 9105 includes similar Figures 26 to 33 The features described herein include a nose 9101, a nasal opening 9103, an oral cavity portion 9102, an oral cavity opening 9104, a cavity 9001, a support structure 9120, a sealing portion 9130, and a vent 9400. Figures 26 to 33 The description is generally applicable to Figures 22 to 25 And 34 to 39, and without discussing the many similarities and differences. A pair of air chamber openings are configured to receive airflow.

[0527] As it is connected to the support structure 9120, the pad assembly 9105 (e.g., specifically, the nose 9101) may include at least one curved surface. This curved surface may extend from the front side to the rear side of the pad assembly 9105 (e.g., see...). Figure 24 A similar curvature can exist on the pad assembly 6105 (e.g., see...). Figure 30 and 31However, unlike pad assembly 6105, pad assembly 9105 (e.g., specifically, nose 9101) may include at least one curved surface, which may be a result of curling in nose 9101, as will be described in more detail below. When using pad assembly 9105, the curved surface of pad assembly 9105 resulting from curling may extend along the transverse direction (e.g., left-right direction) of the patient's face. For example, the curved surface of pad assembly 9105 resulting from curling may be bent about an axis perpendicular to the axis passing through section lines 36-36 (e.g., see...). Figure 34 ), and / or bend around a third axis at 1300° (details below). The curved surface created by the curling may also have a positive curvature relative to the patient's face.

[0528] As mentioned above, Figures 37 to 39 A gripping pad 9150 is shown on the surface of a fabric membrane. The gripping pad 9150 may be on a first sealing portion 9131 and / or a second sealing portion 9132. Although shown as a pad assembly 9105, the gripping pad 9150 may also be incorporated into a pad assembly 6105.

[0529] refer to Figure 33-1 The patient interface 21000 includes a pad assembly 21105 having a sealing formation structure 21100 configured to seal around a patient's nostrils and mouth (e.g., a mouth-nose pad assembly or an ultra-compact full-face mask). The pad assembly 21105 is similar to pad assemblies 6105 and 9105. According to an example of the present technology, the pad assembly 21105 is at least partially formed by an inflation chamber 21200 and the sealing formation structure 21100 attached to the inflation chamber. The sealing formation structure 21100 may also include a curved surface similar to that of the nose 9101.

[0530] refer to Figure 33-2 The patient interface 23000 includes a pad assembly 23105 having a sealing formation structure 23100 configured to seal around the patient's nostrils and mouth (e.g., a mouth-nose pad assembly or an ultra-compact full-face mask). The pad assembly 23105 is similar to pad assemblies 6105 and 9105. According to an example of the present technology, the pad assembly 23105 is at least partially formed by an inflation chamber 23200 and the sealing formation structure 23100 attached to the inflation chamber. The sealing formation structure 23100 may also include a curved surface similar to that of the nose 9101.

[0531] refer to Figures 33-3 to 33-11The patient interface 25000 includes a pad assembly 25105 having a sealing formation structure 25100 configured to seal around a patient's nostrils and mouth (e.g., a mouth-nose pad assembly or an ultra-compact full-face mask). The pad assembly 25105 is similar to pad assemblies 6105 and 9105. According to an example of the present technology, the pad assembly 25105 is at least partially formed by an inflation chamber 25200 and the sealing formation structure 25100 attached to the inflation chamber. The sealing formation structure 25100 may also include a curved surface similar to that of the nose 9101.

[0532] Figures 22 to 39 The full-face pad may share some similarities with the nose pad 3000 described above. For example, the seal-forming structure, described in more detail below, may have selectively applied tension to aid in forming the final shape (e.g., a two-dimensional or three-dimensional shape). Various similarities and differences between the full-face pad and the nose pad 3000 are described below.

[0533] 5.3.3.1 Inflation Chamber

[0534] The inflation chamber 6200 has a periphery that, during use, forms a sealed area shaped to complement the surface contours of a normal person's face. During use, the edges of the inflation chamber 6200 are positioned very close to the adjacent surface of the face. The sealing structure 6100 provides actual contact with the face. The sealing structure 6100 can extend around the entire periphery of the inflation chamber 6200 during use.

[0535] In some forms of this technology, the air chamber 6200 is made of a relatively rigid material (e.g., polycarbonate) compared to the sealing structure 6100. In another example, the air chamber 6200 may be made of a flexible material (e.g., silicone, fabric, etc.) and may have similar rigidity to the sealing structure 6100. In yet another example, the air chamber 6200 may be made of a transparent material (e.g., transparent polycarbonate). The use of transparent materials can reduce obstruction of the patient interface 6000 and help improve treatment adherence. The use of transparent materials can help clinicians observe how the patient interface 6000 is positioned and functions, and / or observe the accumulation of debris (e.g., dust, mold, etc.).

[0536] In some forms of this technology, the air chamber 6200 is made of a translucent material. The use of a translucent material can reduce obstruction of the patient interface 6000 and help improve treatment adherence.

[0537] An example of the present technology, the air chamber 6200, may include an air chamber aperture on each side. The air chamber aperture provides pneumatic communication between the catheter connector 6800 and the cavity 6001, which is described in more detail below. A connecting edge portion surrounding each air chamber aperture may facilitate a mechanical connection with the corresponding catheter connector, such as a snap-fit ​​or friction fit. The air chamber 6200 may be constructed of a sufficiently rigid material to provide auditory and / or tactile feedback to the patient when the catheter connector 6800 is attached to or removed from the air chamber 6200.

[0538] The sealing structure 6100 can be hermetically connected to the inflation chamber 6200. The connection can be permanent, or the sealing structure 6100 can be removed from the inflation chamber 6200. The sealing structure 6100 can be molded (e.g., overmolding, injection molding, etc.) into the inflation chamber 6200. The sealing structure 6100 and the inflation chamber 6200 can be mechanically connected, wherein no chemical bond is formed between the inflation chamber 6200 and the sealing structure 6100.

[0539] 5.3.3.2 Sealing Formation Structure

[0540] refer to Figures 26 to 33 The sealing structure 6100 may include a nose portion 6101 having at least one opening (e.g., a pair of nasal openings 6103) to seal against a patient's nostrils and deliver pressurized air to the patient's nostrils. The depicted example provides two separate openings 6103, each corresponding to one of the patient's nostrils, to provide airflow to both nostrils of two patients. A bridging portion 6106 may be located between the nostril openings 6103. In an alternative example, a single opening may be used to provide airflow to both of the patient's nostrils. Another alternative may include three or more openings. Unlike the bridging portion 3104, the bridging portion 6106 may not be selectively tensioned. For example, the material surrounding the bridging portion 6106 and the nose portion 6101 may be held together under tension, rather than applying tension only to the bridging portion 6106.

[0541] Brief reference Figures 22 to 25 34 to 39 can selectively tension the bridging portion 9106 in a manner similar to that of the bridging portion 3104. For example, the bridging portion 9106 can be tensioned more than the surrounding first sealing portion 9131.

[0542] Continue to refer to Figures 26 to 33The sealing structure 6100 may include an oral portion 6102 having an oral portion orifice 6104 for sealing with a patient's mouth. In some examples, when not in use (i.e., when not in contact with the patient's face), the oral portion 6102 is at least partially held under tension (e.g., at any number of discrete locations). For example, the oral portion may be taut at its connection to the support structure 6120, but relaxed at exposed sealing edges (e.g., the inner edge near the opening of the cavity 6001). In some examples, the oral portion 6102 is completely relaxed when not in use. In any example, contact with the patient's face may stretch the oral portion 6102, thereby putting the oral portion under tension during use.

[0543] The sealing structure 6100 can at least partially form a cavity 6001, which is pressurized by an airflow. An inflation chamber 6200 can be connected to the sealing structure 6100 to further form the cavity 6001.

[0544] The sealing structure 6100 may include a support structure 6120 that provides support for the sealing portion 6130 (e.g., a fabric membrane). The sealing portion is configured to sealably engage with the patient's face. The sealing portion 6130 is large enough (e.g., bent a sufficient amount in the forward direction) that only the sealing portion 6130 (e.g., only the fabric membrane) can contact and sealably engage with the patient's face. Optionally, the support structure 6120 may also be made of a fabric material.

[0545] In one example, the sealing forming structure 6100 may include a support structure 6120 having at least two regions of different thicknesses (e.g., two, three, or four regions). (For example, the sealing forming structure 6100 includes a support structure 6120 having a lateral support region with an increased thickness relative to other parts of the wall structure. See also...) Figure 58 and 59 (The wall structure of 3122 in the text). For example, such as Figure 58 and 59 As shown, some portions 3123 of the support structure 3120 may be thicker than other portions 3124, 3126 of the support structure 3120. For example, the thicker portions 3123 may be adjacent to or connected to the air chamber, and portions 3124, 3126 may be adjacent to or connected to the fabric membrane 3130 to provide structural stability at the connection with the air chamber 3200 and flexibility at the interface with the patient. Alternatively, the thicker portions of the lateral support region 3122 may be located, for example, at the corner of the nasal region of the sealing formation structure (and may be directly connected to the fabric membrane, for example), to ensure adequate sealing in the posterosuperior lateral panel region of the patient's face.

[0546] As described above, the sealing structure 6100 can be sealingly connected to the inflation chamber 6200. The rigidity of the support structure 6120 can be less than that of the inflation chamber 6200, and it can be made of silicone, foam (e.g., polyurethane foam), solid polyurethane material, thermoplastic elastomer (e.g., thermoplastic polyurethane), suitable plastic, or other suitable materials as described below. Furthermore, the rigidity of the sealing portion 6130 can be less than that of the support structure 6120, and it can be made of a fabric material 6130 such as nylon, polyester, nylon and polyester blends, microfiber, or polyurethane, as will be described in more detail later.

[0547] exist Figure 32 In one example, the support structure 6120 may extend into the cavity 6001 to form a bottom pad 6121 to provide support for the sealing portion 6130. The bottom pad 6121 and the sealing portion 6130 may form a double-wall structure around the periphery of the sealing portion. In an alternative example, a second or third bottom pad layer may be provided to form a three- or four-layer wall structure. Figure 32 In one example, the bottom pad is made of a foam material (e.g., polyurethane foam). In an alternative example, the bottom pad 6122 may be made of silicone resin, such as… Figure 33 As shown. However, it will be recognized that the bottom mat can be made of other suitable materials (e.g., fabric).

[0548] The sealing portion 6130 can be composed of two different fabric films. For example, one film 6131 can be used to seal around the patient's nose, while another film 6132 can be used to seal around the patient's mouth. Sealing portions 6131 and 6132 can be used to independently seal individual openings. In other words, the first or upper sealing portion 6131 may not contact the area around the patient's mouth, while the second or lower sealing portion 6132 may not contact the area around the patient's nose.

[0549] like Figures 26 to 33 As shown, compared to the second sealing portion 6132, the first sealing portion 6131 is disposed on the upper part of the patient interface 6000 (i.e., when in use). The first sealing portion 6131 forms a circular (e.g., generally tri-elliptical) periphery that surrounds the patient's nostrils during use.

[0550] In some forms, the first sealing portion 6131 may contact the area between the nasal ala and the upper lip, while exposing the nasal protuberance (see, for example, [link to document]). Figures 23 to 25(A similar first sealing portion 9131 is shown). The fabric membrane of the first sealing portion 6131 may be the only material of the sealing forming structure 6100 that comes into contact with the patient in this area. In other words, the second sealing portion 6132 and the support structure 6120 do not come into contact with the patient in this area. This can help improve patient compliance because patients only come into contact with the fabric layer in their facial area, where they may be more closely bound to the sheets than to the medical device.

[0551] The second sealing portion 6132 is disposed at the lower part of the patient interface 6000 (i.e., when in use and compared to the first sealing portion 6131). In the example shown, the second sealing portion 6132 is generally U-shaped and seals around a portion of the patient's mouth. The fabric membrane forming the second sealing portion 6132 does not extend completely around the patient's mouth. In other words, other materials besides the fabric membrane may come into contact with the patient, thereby forming a seal around the patient's oral cavity. In this example, a support structure 6120 (e.g., silicone material) is molded between the free ends of the second sealing portion 6132 to complete the oral cavity portion orifice 6104. The fabric membrane of the second sealing portion 6132 may contact the patient's lower lip, the area outside the corner of the patient's mouth, and a portion of the patient's upper lip, and may not contact the central portion of the patient's upper lip (e.g., near the patient's philtrum). The support structure 6120 extends across the patient's philtrum between the ends of the second sealing portion 6132. The combination of the fabric membrane of the sealing part 6130 and the silicone material of the supporting structure 6120 is responsible for forming a seal around the patient's mouth.

[0552] The support structure 6120 extends from the lower surface of the first sealing portion 6131 to the opening of the cavity 6001. In other words, the first sealing portion 6131 is separated from the second sealing portion 6132 by the support structure 6120. The material of the support structure 6120 (e.g., silicone) also facilitates bonding the first sealing portion 6131 and the second sealing portion 6132 to each other during the manufacturing process.

[0553] like Figure 33-1As shown, the second sealing portion 21130b extends completely around the patient's mouth. In other words, the fabric membrane contacts the philtrum relative to the support structure 21120. The support structure 21120 (e.g., silicone material) is disposed vertically between the first sealing portion 21130a and the second sealing portion 21130b (e.g., a first segment and a second segment). Although the seal is primarily or solely achieved through the fabric membrane in the first sealing portion 21130a and the second sealing portion 21130b, the support structure 21120 may slightly contact the upper lip of the patient. In other words, during treatment, the area where the support structure 21120 contacts the patient's skin may be free from pressure and / or exposure to the surrounding environment. Compared to the U-shaped second sealing structure 21130b, having the second support structure 21130b extend continuously around the patient's mouth can provide greater comfort to the patient (e.g., because the patient may find the fabric membrane more comfortable than the silicone membrane), which may increase patient compliance with treatment.

[0554] In another example of the patient interface 23000, such as Figure 33-2 As shown, the second sealing portion 23130b is U-shaped. However, the upper end and central portion of the upper lip are in contact with a fabric membrane. In this example, the first sealing portion 23130a extends downward to the edge of the oral cavity portion opening 23104. In other words, the first sealing portion 23130a is responsible for forming a seal around the patient's nose and also partially responsible for forming a seal around the patient's mouth. The U-shaped second sealing portion 23130b extends substantially around the rest of the patient's mouth (although a small portion of the support structure 23120 is laterally positioned between the first and second sealing portions 23130a and 23130b in the left-right direction). This example can provide information related to the above regarding... Figure 33-1 The similar comfort benefits described (e.g., because virtually all contact between the patient's nose and mouth via the patient interface 23000 is made by a fabric membrane). However, Figure 33-2 The example can be made more easily because the support material 23120 between the first sealing portion 23130a and the second sealing portion 23130b is removed in the vertical direction. A small portion of the support structure 23120 between the sealing portions 23130a and 23130b can help form a pressurized volume around the patient's mouth.

[0555] In another example of the patient interface 25000, such as Figure 33-3As shown, the sealing portion 25130 is formed from a single piece of fabric material. In other words, the first sealing portion 25130a and the second sealing portion 25130b are not made of separate materials. The single piece of material forming the sealing portion 25130 is responsible for forming a seal around the patient's nose and mouth. The sealing portion 25130 may have a periphery similar to that described above (e.g., in the example of the patient interface 25000 having the first and second sealing portions 25130). In some examples, the sealing portion 25130 may only seal around its periphery, because not sealing the patient's upper lip may prevent air leakage from the sealing forming structure 25100. However, the sealing portion 25130 may still seal the patient's upper lip to allow pressurized air to be delivered more directly to the patient's airway. By using a single piece of fabric membrane to form the sealing portion 25130, the support structure 25120 may not contact the patient's upper lip. Additionally, since it is no longer necessary to form strips of support structure 25120 between the two fabric membranes to connect them, manufacturing the patient interface may be easier. Therefore, the molding process can be simplified so that small amounts of material (such as silicone) do not need to flow between them and do not need to be covered with fabric layers 10133.

[0556] like Figures 22 to 25 As shown in Figures 31-1 to 39, each sealing structure can have a three-dimensional shape. Specifically, each first sealing portion can have a shape similar to... Figures 26 to 33 The planar surface (e.g., along the left-right direction) is contrasted with a curved surface (e.g., along the left-right direction). The three-dimensional shape can be formed at least partially by selectively applying tension to the bridging portion of the respective first sealing portion. Tension may not be applied to the material surrounding the bridging portion of the first sealing portion on the respective sealing formation structure, such that the first sealing portion may include a curved shape.

[0557] In any of these embodiments (e.g., Figures 22 to 39 The strength of the seal against the patient's face is substantially the same. For example, having only fabric material, or a combination of fabric and silicone material, will not substantially affect the quality of the seal (i.e., increase or decrease the leakage area). Different patients (e.g., different facial geometries) may be better suited to one particular example than others (e.g., due to comfort, fit, etc.). Additionally, although an example with more fabric coverage may provide additional comfort to the patient, the increased comfort may be minimal (e.g., due to minimal contact provided by the support structure 6120 with both the first sealing portion 6131 and the second sealing portion 6132 in the example).

[0558] 5.3.3.3 Positioning and Stabilizing Structure

[0559] The sealing structure 9000 of the patient interface 9100 of this technology can be held in a sealed position during use by the positioning and stabilizing structure 9300. Although the positioning and stabilizing structure 9300 is specifically shown as having the patient interface 9000, it can be used with any full-coverage pad (e.g., Figures 22 to 39 (Any example) can be used together. The positioning and stabilizing structure 9300 can also be similar to the positioning and stabilizing structure 3300.

[0560] In one configuration, the positioning and stabilizing structure 9300 provides a holding force sufficient to overcome the positive pressure in the cavity 9001 to elevate away from the face.

[0561] In one configuration, the positioning and stabilizing structure 9300 provides holding forces to overcome the effects of gravity on the patient interface 9000.

[0562] In one configuration, the positioning and stabilizing structure 9300 provides a holding force as a safety margin to overcome the potential impact of destructive forces on the patient interface 9000, such as destructive forces caused by tube resistance or accidental interference with the patient interface.

[0563] In one form of this technology, a positioning and stabilization structure 9300 is provided, configured in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilization structure 9300 has a small side or cross-sectional thickness to reduce the sensing or physical volume of the device. In one example, the positioning and stabilization structure 9300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilization structure 9300 includes at least one flat strap.

[0564] In one form of this technology, a positioning and stabilizing structure 9300 is provided, which is configured not to be too large or bulky to prevent the patient from lying in a supine sleeping position and to place the back area of ​​the patient's head on a pillow.

[0565] In one form of this technology, a positioning and stabilizing structure 9300 is provided, which is configured not to be too large or bulky to prevent the patient from lying in a side-lying sleeping position and to place the side area of ​​the patient's head on the pillow.

[0566] In one form of this technology, the positioning and stabilizing structure 9300 is configured to have a decoupling portion between its front and rear portions. The decoupling portion does not resist compression and can be, for example, a flexible band or soft strap. The decoupling portion is constructed and arranged such that when a patient rests their head on the pillow, its presence prevents forces at the rear from being transmitted along the positioning and stabilizing structure 9300 and disrupting the seal.

[0567] In one embodiment of this technology, the positioning and stabilizing structure 9300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one embodiment, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one embodiment, the fabric outer layer includes a loop material to partially engage with a hook material. In one embodiment, a conduit 9900 for delivering air to the pad assembly 9105 may also constitute the positioning and stabilizing structure 9100.

[0568] In some forms of this technology, the positioning and stabilizing structure 9300 includes a strap that is extendable, for example, elastically extendable. For example, the strap may be configured to be taut during use and to guide forces to bring the sealing structure into sealed contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0569] In one form of this technology, the positioning and stabilizing structure may include a first tether (e.g., an upper strap 9302). Figure 24 The first frenulum is constructed and arranged such that, in use, at least a portion of its lower edge passes over the base point above the ear on the patient's head.

[0570] In one form of this technology applicable to full-face masks, the positioning and stabilizing structure includes a second strap (e.g., a lower strap 9303). Figure 42 The second frenulum is constructed and arranged such that, in use, at least a portion of its upper edge passes below the auricular base of the patient's head and covers or lies below the occipital bone of the patient's head.

[0571] In one form of this technology applicable to nose masks or full-face masks only, the positioning and stabilizing structure includes a third strap (e.g., a strap connector 9304). Figure 22 The third lacing band is constructed and arranged to interconnect the first and second lacing bands to reduce the tendency of the first and second lacing bands to move apart from each other.

[0572] In some forms of this technology, the positioning and stabilizing knot 9300 includes a strap that is flexible and, for example, non-rigid. An advantage of this is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0573] In some forms of this technology, the positioning and stabilizing structure 9300 includes a strap that is configured to be breathable to allow moisture to be transferred through the strap.

[0574] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 9300, each configured to provide a holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 9300 suitable for large-sized heads but not for small-sized heads, while another form of sealing formation structure suitable for small-sized heads but not for large-sized heads.

[0575] The positioning and stabilizing structure 9300 may include a clip 9301 to secure a corresponding tether, for example, to the catheter connector 9800, such as Figure 22 As shown. Clip 9301 and conduit connector 9800 may each include a magnet arranged with opposite polarities to facilitate connection between them.

[0576] 5.3.3.4 Vent

[0577] In one embodiment, the patient interface 6000 includes a ventilation port 6400 configured and arranged to allow the expulsion of exhaled gases, such as carbon dioxide, etc. Figure 30 As shown.

[0578] In some configurations, the airway 6400 is configured to allow continuous airflow from the inflation chamber 6200 to the environment, while the pressure in the inflation chamber is positive relative to the environment. The airway 6400 is configured such that the airflow rate is sufficient to reduce the rebreathing of exhaled CO2 by the patient, while maintaining the therapeutic pressure in the inflation chamber during use.

[0579] One form of the vent 6400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0580] Vent 6400 may be located in inflation chamber 6200. Optionally, vent 9404 may be located in a decoupling structure, such as a rotating shaft (e.g., Figure 22 ).

[0581] The catheter connector 6800, which will be described in more detail below, may also include a vent feature.

[0582] 5.3.3.5 Decoupling Structure

[0583] In one form, the patient interface 9000 includes at least one decoupling structure, such as a swivel or a ball head and a ball socket.

[0584] 5.3.3.6 Connection Port

[0585] Connection port 6600 allows connection to pipe 6348 of air circuit 4170 (see, for example, see...). Figure 7 According to an example of this technology, connection port 9600 can be connected to connection port housing 9903 (see, for example, see...). Figure 22 The connection port 9600 can rotate relative to the connection port housing 9903, and the connection to the air circuit 4170 can also be rotatable.

[0586] When in use, the connection port 9600 and the connection port housing 9903 can be positioned above the patient's head.

[0587] 5.3.3.7 Forehead support

[0588] Figures 22 to 39 The example patient interface of this technology shown does not include a forehead stent. Variations of the patient interface of this technology may include a forehead stent.

[0589] 5.3.3.8 Loop

[0590] A patient interface 9000 according to an example of this technology may include a catheter 9900 to provide a pressurized airflow from a connection port 9600 to a cavity 9001 in an inflation chamber 9200. The catheter 9900 may be similar to Figure 6 The horizontal portion 3302 and the upper portion 3304 and Figure 7 The tube 6350. The catheter 9900 can be connected to the patient's head above the connection port housing 9903 and can pass along the side of the patient's head between the corresponding eyes and ears. The catheter 9900 can be connected via the catheter connector 9800 to the pad assembly 9105 (e.g., the air chamber 9200), as described below, to provide a pressurized airflow to the cavity 9001.

[0591] The catheter 9900 can also stabilize and position the sealing structure 9100 on the patient's face. Therefore, the catheter 9900 can function similarly to the tether of the positioning and stabilizing structure 9300. Thus, the mechanical connection between the catheter 9900 and the catheter connector 9800 may be sufficient to allow tension in the catheter 9900 to be transmitted through the catheter connector 9800 to the sealing structure 9100.

[0592] The catheter 9900 may include features of a similar catheter disclosed in International Application Publication No. WO 2017 / 124155 A1, the entire contents of which are incorporated herein by reference. For example, the catheter 9900 of this technology may include features described in this document. Figures 3A to 3L Features of the headband tube 3350 as described in Chinese and related written descriptions.

[0593] The catheter 9900 may also be provided with a sleeve 9901 to cushion the patient's face against the catheter 9900. The sleeve 9901 is removable. The sleeve 9901 may be made of a breathable material.

[0594] The conduit 9900 may also include a tether connector 9902 to facilitate connection with the tether of the positioning and stabilizing structure 9300.

[0595] 5.3.4.1.7 Conduit Connector

[0596] like Figures 26 to 33 As shown, according to an example of the present technology, patient interface 6000 may include catheter connector 6800 of patient interface 6000. The catheter connector can connect a catheter to pad assembly 6105 to provide a pressurized airflow to cavity 6001. These catheter connectors 6800 may be similar to catheter connector 9800 (e.g., see...). Figures 22 to 25 The following description is equally applicable to the 9800 conduit connector.

[0597] Each conduit connector 6800 may be formed with a conduit connector housing 6801. The conduit connector 6800 may provide other functions, as described below, such as venting the inflation chamber 6200, connection to positioning and stabilizing structures, and prevention of suffocation by including an anti-suffocation valve 6850.

[0598] exist Figures 26 to 33 In the diagram, a conduit connector 6800 is shown attached to an air chamber 6200 at an air chamber aperture (e.g., see similar air chamber aperture 9210). It can be seen that there is one conduit connector 6800 on each side of the pad assembly 6105, and each conduit connector 6800 is connected to an air chamber aperture on each corresponding side of the pad assembly 6105. Each conduit connector 6800 may include a conduit connector attachment structure to connect each conduit connector 6800 to a corresponding air chamber aperture at a connection edge (not shown). This connection may be mechanical, such as a snap-fit ​​or friction fit. The connection may also be removable. The materials of the conduit connector 6800 and the air chamber 6200 may be chosen separately to facilitate desired connection features. For example, the materials of the conduit connector 6800 and the air chamber 6200 may each be relatively rigid to allow auditory and / or tactile feedback associated with a snap-fit. At least in one aspect, the materials of the conduit connector 6800 and the air chamber 6200 may be different, or they may be the same. The catheter connector 6800 can also be permanently attached to the inflation chamber at the inflation chamber orifice. For example, the catheter connector 6800 can be ultrasonically welded to the inflation chamber 6200. The connection between the catheter connector 6800 and the inflation chamber 6200 (whether removable or permanent) can also be designed to be strong enough that tension from the catheter can be transferred to the inflation chamber 6200 without interrupting the connection, because, as explained above, the catheter connector 6800 can facilitate the positioning and stability of the sealing structure 6100 on the patient's head.

[0599] The catheter connector 6800 can also be attached to the side of the inflatable chamber 6200 to improve the aesthetics of the patient interface 6000. As explained above, the inflatable chamber 6200 can be made of a transparent or translucent material, which allows the patient's facial features to be visible. By laterally positioning the catheter connector 6800 on the inflatable chamber, for example, as shown in the illustrated example, more of the patient's face is visible, and this arrangement improves the aesthetics of the patient interface 6000. This contrasts with an alternative design in which a bend and air circuit can be connected to the center of the inflatable chamber 6200, thereby obscuring the patient's view of their face.

[0600] The catheter connector 6800 may also each include a connection to the corresponding catheter (e.g., similar to...). Figure 22 The catheter connector 6802 (of the catheter 9900) is a catheter connection end. The connection between the catheter and the catheter connector 6800 at the catheter connection end 6802 can be removable or permanent. A catheter connector inlet hole 6803 can be formed in the catheter connector housing 6801 at the catheter connection end 6802 to receive pressurized airflow. The catheter connector 6800 can include, for example, undercut structures to facilitate a removable, snap-fit ​​connection with the corresponding catheter, and each catheter can include a relatively rigid structure at the end connected to the catheter connector 6800 to facilitate such a connection. The catheter connector 6800 can also be connected to the catheter by a friction fit, snap fit, or any similar fit. Again, as explained above, the catheter provides positioning and stabilization functions to position the sealing structure in a therapeutically effective sealing position on the patient's face, so the connection between the catheter and the catheter connector 6800 at the catheter connection end 6802 can be strong enough to allow tension from the catheter to be transmitted to the catheter connector 6800 without disrupting the connection between the catheter and the catheter connector 6800 at the catheter connection end 6802.

[0601] like Figure 29 As shown, the catheter connector 6800 also provides ventilation functionality for the patient interface 6000. The catheter connector housing 6801 may include a vent inlet that is pneumatically connected to the cavity 6001 when the patient interface 6000 is assembled. The catheter connector housing 6801 may also include at least one catheter connector vent 6831. As can be seen from the depicted example, each catheter connector housing 6801 includes multiple catheter connector vents 6831. This ensures adequate mixing of newly introduced air with the air already present in the inflation chamber 6200, which enhances carbon dioxide flushing and increases the amount of fresh air provided to the patient for breathing.

[0602] like Figures 22 to 24As shown, a similar catheter connector 9800 can also provide a connection to a tether of the positioning and stabilizing structure 9300. The lower tether can be connected to the catheter connector 9800 via a clip 9301. The clip 9301 and the catheter connector 9800 may include magnets of opposite polarities to facilitate connection. The connection between the tether of the positioning and stabilizing structure 9300 and the catheter connector 9800 can be releasable. Tension from the lower tether of the positioning and stabilizing structure 9300 can cause the lower part of the sealing forming structure 9100 to seal against the patient's face, for example, around the mouth. Alternatively, a structure for connection to the clip 9301 can be formed directly on the catheter connector housing.

[0603] 5.3.3.10 Anti-suffocation valve

[0604] In one configuration, the patient interface 6000 includes an anti-asphyxiation valve. For example... Figure 30 and 31 As best shown, each catheter connector 6800 may include an anti-asphyxiation valve assembly 6850. Therefore, the patient interface 6000 may include two anti-asphyxiation valve assemblies 6850. Each anti-asphyxiation valve assembly 6850 may operate independently of the other (i.e., in response to cessation of airflow pressurization). For example, if the patient is sleeping on their side when airflow pressurization stops, and one of the anti-asphyxiation valve assemblies 6850 is, for example, blocked by a pillow, the other anti-asphyxiation valve assembly 6850 may be used to prevent the patient from suffocating. Although not explicitly shown, Figures 22 to 25 The patient interfaces of 33-1 to 39 may also include at least one anti-asphyxiation valve.

[0605] Port 5.3.3.11

[0606] In one embodiment of this technology, the patient interface 6000 includes one or more ports that allow access to the volume within the inflation chamber 6200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows direct measurement of the properties of the gas within the inflation chamber 6200, such as pressure. Although not explicitly shown, Figures 22 to 25 Patient interfaces 33-1 to 39 may also include at least one port.

[0607] 5.3.4 Arrangement of Support Structure and Sealing Components

[0608] The support structure and sealing components in the above example can have many different configurations and arrangements.

[0609] In use, the sealing portion 3130 (e.g., a fabric membrane) can maintain a sealed contact with the patient's face by: 1) the reaction stress of the supporting structure 3120; 2) the pre-formed state of the fabric membrane 3130, formed as an untensioned but substantially constant surface, without leakage causing interruptions, such as wrinkles, creases, bends, or folds in the fabric membrane 3130; and / or 3) the air pressure within the cavity against the inner surface of the sealing portion 3130. Each of these factors can cause the sealing portion 3130 to conform to the anthropometric contours of the patient's face, thereby minimizing wrinkles or blowouts and maximizing the contact area of ​​the sealing portion 3130. Due to any of these factors, the tension in the sealing portion 3130 may increase, but the sealing portion 3130 may return to a relaxed state upon removal of the relevant factors.

[0610] In some examples, the sealing portion 3130 may comprise a relatively thin, compliant, stretchable, elastic material, such as a fabric membrane comprising a suitable woven material (e.g., nylon, polyester, nylon and polyester blends, microfibers, or polyurethane). The sealing portion 3130 may be molded or otherwise attached (e.g., adhered, glued) to the support structure 3120 such that there are no wrinkles in the material of the sealing portion 3130. This can be advantageous in ensuring that the sealing portion forms a smooth and continuous seal on the patient's face without any folds that could allow air leakage. Furthermore, the sealing portion 3130 may be shaped or given curvature. The support structure 3120 may also give curvature to the sealing portion 3130. In the example shown, the sealing portion 3130 may include curvature about multiple axes. This can help the sealing portion 3130 conform to the contours of the complex facial structures of different patients.

[0611] For example, such as Figures 12 to 21 As shown, the sealing portion 3130 may have a concave curved profile (e.g., a positive arch curvature in the left-right direction) from one side (right) to the opposite side (left) to support the patient's nose when the patient interface 3000 is worn. In other words, the curvature of the sealing portion 3130 is positive relative to the position of the patient's columella and / or subnasal point contacting the sealing portion 3130.

[0612] In some forms, such as Figures 11 to 39 As shown, the patient's nose is not intended to be contained within the cavity 3101 formed by the inflation chamber 3200 and the sealing structure 3100. Instead, unlike a conventional mask, the patient's nose is designed to rest against a fabric membrane 3130, which in turn conforms to the contours of the patient's face to comfortably form a reliable seal with the patient's airway. The fabric membrane 3130 can be stretched to fit the patient's face. Specifically, before contact with the patient, Figures 11 to 21 Fabric membrane 3130 and Figure 31The fabric membranes in -1 to 39 can be kept in a relatively relaxed (i.e., unstretched) state. When a patient (e.g., through their nose) contacts the fabric membrane 3130, the seal-forming structure 3100 forms onto the patient's face (e.g., their nose) due to its compliant, stretchable nature. In other words, contact with the patient's face applies tension to the fabric membrane 3130, causing it to form a shape complementary to the patient's nose. The relaxation in the initial formation of the seal-forming structure 3100 compared to when it is initially stretched allows for better contouring of the patient's face because there are fewer locations where the shape can be altered. Some examples include a bridging portion 3104, which can be used to help provide a sealing portion by eliminating a central opening on the fabric membrane 3130, which presses against the patient's nose rather than accommodating the patient's nose within the cavity 3101. The bridging portion 3104 can create a position where the patient can apply tension to the fabric membrane 3130, causing the seal-forming structure 3100 to fit snugly against and / or against the patient's facial features (e.g., to limit and / or prevent leakage). This also creates a different sealing experience compared to a conventional mask. This sealing experience provides enhanced comfort due to contact with the compliant fabric membrane 3130, rather than with the harder material in a conventional mask or conventional sealing arrangement, where the sealing portion 3130 has a smaller contact area around the nose and / or mouth. The bridging portion 3104 (or any area that can be selectively tensioned) can create a position where the patient can apply tension to the fabric membrane 3130, regardless of whether the bridging portion 3104 is located near at least one opening.

[0613] Before contact with a patient, the fabric membrane 6130 (e.g., the first sealing portion 6131) can be held in a relatively taut state (e.g., the first sealing portion 6131 can be under continuous tension). When a patient (e.g., through their nose) contacts the fabric membrane 6130, the seal-forming structure 6100 forms onto the patient's face (e.g., their nose) due to its compliant, stretchable nature. In other words, contact with the patient's face applies additional tension to the fabric membrane 6130, causing it to form a shape complementary to the patient's nose. The entire first sealing portion 6131 can function in a similar manner to the bridging portion 3104 described above, as it can create a position where the patient can apply tension to the fabric membrane 6130, causing the seal-forming structure 6100 to adhere tightly to and / or press against the patient's facial features (e.g., to limit and / or prevent leakage). When the fabric membrane 6130 is stretched, the material may be soft or elastic, allowing it to adapt to the patient's facial features by applying additional tension. Compared to a pressurized seal generated solely by a pressurized airflow, the combination of pretension in the first sealing portion 6131 and a pressurized seal generated by a pressurized airflow can produce a more robust seal (e.g., in patient interfaces 3000, 9000, 21000, 23000, 25000).

[0614] Compared to conventional silicone membranes and compressed foam seals, the sealing portion 3130 in some of these examples has a more flexible structural stiffness, thus exhibiting dynamic rebound characteristics that allow the sealing portion 3130 to recover more quickly when subjected to external forces. Furthermore, due to the lower structural stiffness, a smaller sealing force is required, allowing the sealing portion 3130 to be more comfortable and to develop fewer facial marks during use.

[0615] Fabric membrane 3130 may exhibit variable tension throughout the material (e.g., less tension near the nostril opening 3102 or in wider stretch portions of the material). Because the central portion of fabric membrane 6130 may be less supported and slightly looser compared to its periphery, fabric membrane 6130 may also exhibit less tension near the nostril 6103. In some forms, the surface of the material in contact with the patient's face in the sealing portion (e.g., 3130) may have low-friction properties (e.g., low-friction finish), which can advantageously improve the material's conformity to the patient's face while also improving patient comfort.

[0616] Fabric membrane 3130 may exhibit variable tension in the material (e.g., greater tension near the bridging portion 3104). Fabric membranes 9130, 21130, 23130, and 21530 may exhibit similar variable tension. In some forms, the surface of the material of fabric membrane 3130 that contacts the patient's face may have low-friction properties (e.g., low-friction finish), which can advantageously improve the material's compliance with the patient's face while also improving patient comfort.

[0617] In some examples, an underlayer padding layer (e.g., a portion or second wall 3126) can help optimize the contact surface area between the sealing portion 3130 and the patient's face. Furthermore, in examples where the sealing portion 3130 is made of a breathable material (e.g., breathable fabric), the underlayer padding layer can provide sufficient contact area behind the sealing portion to adequately seal it against the patient's face and prevent leakage.

[0618] The bottom pad layer provides additional flexibility and allows the pad to fit the face of most patients (e.g., universal size). For example, the sealing portion can be configured as a dual air-assisted sealing portion (e.g., a dual fabric membrane), a sealing portion with a compression support (e.g., open-cell foam, polyurethane foam, gel), a sealing portion with a TPU, TPE, or silicone support, or a dual air-assisted sealing portion with an additional support (e.g., a dual fabric membrane, wherein the inner membrane has a foam laminate layer (e.g., open-cell, polyurethane) or a TPU, TPE, polyurethane, or silicone molded layer thereon).

[0619] During use, the engagement of the patient's face 1000 with the sealing portion 10130 will generate a temporary strain force that attempts to pull the walls of the supporting structure 10120 toward each other, such as... Figure 43 As shown. The support structure 10120 will respond to the strain force using an outward pulling reaction force. The reaction force transfers more tension to the sealing portion 10130 by preferentially stretching the more compliant sealing portion, which generates a synthetic elastic force in the sealing portion that is applied to the patient's face.

[0620] The sealing portion 10130 can be integrally formed with the support structure 10120 by molding or otherwise attaching it to the inner edge of the support structure 10120. Thus, for example, the outer periphery of the sealing portion 10130 can be attached to the inner edge of the support structure 10120 such that the sealing portion 10130 extends radially inward beyond the support structure 10120 or extends radially greater than the support structure 10120. The inner edge of the support structure 10120 can be bent so that the sealing portion 10130 can be slightly tilted inward toward the inside of the mask. By attaching the sealing portion 10130 along the inner edge of the support structure 10120, it is not necessary to fold or cut the sealing portion 10130 to fuse around the corners of the support structure 10120. This can help reduce the occurrence of protruding creases or wrinkles in the sealing portion 10130 (which could cause leakage), thereby improving the sealing performance.

[0621] 5.3.4.1 Fabric membrane

[0622] According to examples of the disclosed technology, the sealing structure 3100 may include a fabric membrane 3130 comprising a fabric material (e.g., see 10133). The fabric material may have an airtight diaphragm / film or layer coated or otherwise applied thereon to produce an airtight fabric composite. The fabric composite may be cut (e.g., die-cut, ultrasonic, laser, or RF cut) into the desired shape and then attached to the support structure 3120. The resulting fabric sealing portion 3130 (or fabric membrane) may be attached to the support structure 3120 (e.g., silicone, TPE), for example, by overmolding or injection molding. In another example, the fabric sealing portion 3130 may be thermally welded to the material (e.g., silicone, TPE) of the support structure 3120 at its edges (outer periphery). In another example, the fabric sealing portion 3130 may not be attached to the support structure 3120, and the pad interface 3105 may be constructed substantially of fabric material.

[0623] In one example, fabric material 10133 is an elastic fabric. This can include knitted materials, braided materials, or any other suitable materials. Knitted materials are particularly preferred over braided materials because they provide elasticity (e.g., stretchability) to the fabric. This can be advantageous in providing comfort to the patient, as described below. The elasticity can be in all directions (e.g., four-way stretch / elasticity, where elasticity is substantially equal in all directions) and at least in the transverse left-right direction of the fabric membrane. The fabric material can have, for example, a weft-knitted or warp-knitted structure. Fabric material 10133 can also be any other suitable knitted structure. Weft-knitted structures are likely more desirable because weft-knitted fabrics are more elastic than warp-knitted fabrics.

[0624] Figure 45This shows the warp 70 of the weft-knitted fabric, or the direction in which the loops of one row of yarns connect to the loops of another row of yarns. Figure 46 The direction of the coils is shown in the 80th row or from a single row of wires. Figure 47 The basic closed-loop warp knitting 90 is shown, in which the longitudinal and transverse rows extend parallel to each other. Figure 48 The weft knit 100 is shown, in which the warp 70 extends perpendicularly to the row 80.

[0625] 5.3.4.1.1 Manufacturing

[0626] The human face encompasses various contours, which can be described as having positive or negative curvature, as well as dome-shaped or saddle-shaped regions. To provide increased patient comfort, the seal-forming structure 3100 ideally matches or substantially matches these contours. However, as mentioned above, the seal-forming structure 3100 should be smooth and continuous on the patient's face, without any folds through which air could leak. Therefore, the complex geometry of the seal-forming structure 3100 needs to be formed with multiple curvatures to complement the patient's face without creating a surface prone to leakage.

[0627] like Figure 49 As shown, the fabric material (e.g., fabric membrane 3130) can be wound around a single axis 11000 (e.g., as shown in the diagram). Figure 49 The horizontal axis shown is folded. In this state, as... Figure 49 As shown, fabric material 3130 has a negative arched curvature (e.g., substantially convex). Fabric material 3130 is substantially smooth in this direction (e.g., the curvature has a constant radius R). In other words, fabric material 3130 is substantially free of wrinkles and / or creases when oriented in the folding direction around a single axis 11000. This will remain correct regardless of which axis or direction the fabric material 3130 is folded around. In other words, fabric material 3130 can be folded about a vertical axis (i.e., instead of a horizontal axis) and / or can have a positive arched curvature (i.e., instead of a negative curvature), and the surface 3130 of the fabric material will be substantially free of wrinkles and / or creases. Furthermore, changing the magnitude of the curvature does not produce wrinkles and / or creases in the fabric material. In other words, a single fold in the fabric material can include a large radius of curvature or a small radius of curvature without producing wrinkles and / or creases in the fabric material. Therefore, different positive and negative curvatures (e.g., such as...) can be... Figures 3B to 3C (As shown in 3E to 3F) is applied to fabric materials without producing wrinkles and / or creases.

[0628] To compensate for the complex surface orientation of patients (and the differences between patients), a multi-folded seal-forming structure 3100 is desirable to provide greater contact with the patient's face. Ideally, these curves would be around different, non-parallel axes, as the curvature of the patient's face revolves around various axes pointing in multiple directions. However, as... Figure 50 As shown, adding additional folds (e.g., second, third, fourth, etc.) to the fabric material can create wrinkles and / or creases. Creases and / or wrinkles may occur when two or more folds are created along non-parallel axes 11000, 11500. In other words, multiple folds along parallel axes may not create wrinkles and / or creases, but they also will not create a three-dimensional shape best suited for sealing the patient's face (e.g., because it does not match the patient's facial contours). By including curvature along non-parallel axes, the surface may no longer remain smooth and continuous. Therefore, any seal-forming structure 3100 made of fabric with two or more folds is unlikely to effectively seal the patient's face.

[0629] One method to effectively create curvature in a material along multiple non-parallel axes is to apply tension to at least a portion of the fabric material 3130. The application of tension can help maintain the shape of various curvatures while also limiting and / or preventing the formation of creases and / or wrinkles.

[0630] One way to apply tension is to stretch the fabric material 3130 and, while under tension, impart multiple curvatures (e.g., along multiple non-parallel axes) to the fabric material. The fabric material 3130 can then undergo a treatment (e.g., thermoforming) such that the fabric material 3130 can be permanently held in its deformed state (i.e., possessing its multiple curvatures). Figure 51 As shown, the fabric material 3130 has multiple curvatures and its surface remains relatively smooth. Therefore, this fabric material 3130 can be incorporated into the patient interface 3000 as a sealing element forming structure 3100, providing a seal to the patient's face while virtually no pressurized air leaks from the inflation chamber 3200 into the surrounding environment. In this example, essentially the entire fabric material 3130 is under tension.

[0631] However, once the fabric material 3130 is stretched and thermoformed (or a similar process is applied), it essentially loses its free-state properties. For example, the elasticity naturally present in the fabric material 3130 is essentially lost after thermoforming. The once elastic fabric material 3130 becomes relatively stiff while incorporating multiple curvatures. The free-state properties of the fabric material 3130 (i.e., before thermoforming) (e.g., drape, flexibility, elasticity, etc.) are also important in determining the sealing capability of the final fabric seal-forming structure 3100. Since the material 3130 is no longer in its free state, the quality of the seal produced by the fabric material 3130 may also be reduced for some patients. In other words, although using a thermoformed, curved fabric material 3130 may be more comfortable in terms of conforming to the patient's face (e.g., compared to a fabric membrane 3130 that only forms a single curve), the loss of its free-state properties may impair the ability of the patient interface 3000 to effectively seal the face of some patients. Even if there are no wrinkles and / or creases, the seal-forming structure 3100 formed in this way may still allow leakage (e.g., because the fabric membrane 3130 is too stiff to conform to the face of some patients). Other patients may experience a seal sufficient to prevent leakage.

[0632] exist Figures 26 to 33 This is not the case with the fabric material 6130, as the material may still retain its free-state properties. Since the first sealing portion 6131 is intended to be substantially flat before use, thermoforming of the material to maintain its shape is unnecessary. The material may still stretch and conform to the patient's face. Therefore, unlike the example above, the fabric material 6130 may be able to limit leakage. Because the fabric material 6130 may not include complex curvatures, the patient interface 6000 may also be easier to manufacture.

[0633] Figures 52 to 61 Another method is shown where tension is applied only to a portion of the fabric membrane 3130. For example, less than half of the fabric membrane 3130 may be under tension, while the remainder may be loose or slack. Thus, tension is selectively applied to discrete locations of the fabric membrane 3130. Different locations of the fabric membrane 3130 (e.g., the central portion, the sides, etc.) can be tensioned to help impart curvatures of different shapes. Additionally, more than one location of a single fabric membrane 3130 may be under tension. Various techniques can be used to selectively apply tension to the fabric membrane 3130, some of which are described below.

[0634] An exemplary technique for selectively applying tension to only a portion of the fabric membrane 3130 can be achieved by applying a curl to a portion of the fabric membrane 3130. This curl can apply localized tension without causing the entire fabric membrane 3130 to be formed under tension. The curl can be applied to any one or more portions of the fabric membrane 3130. In some examples, a large portion of the fabric membrane 3130 is not curled. In other words, the area of ​​the curled fabric membrane 3130 is smaller than the area of ​​the uncurled fabric membrane 3130. In some examples, a segment of fabric material 3130 can be removed from at least one side of the curled portion. In some examples, holes or other discontinuities are not required to form the curled portion.

[0635] In some examples, curling can be applied to the central portion of the fabric membrane 3130. This curling can be performed by removing a portion of the fabric material 3130 while the fabric is in a free state (i.e., before it has been thermoformed) (e.g., to form holes 3102). The fabric material 3130 can then be manipulated around the formed holes 3102 to limit the formation of any wrinkles and / or creases. These holes 3102 can later be used as nasal openings through which pressurized air can be delivered to the patient's nostrils.

[0636] like Figure 52 The diagram shows fabric material 3130 in a patient interface 3000 for use only in the nasal cavity. Two holes 3102 are cut into the fabric material (e.g., by hand, with a laser, etc.), each hole 3102 corresponding to a single nostril of the patient. However, depending on the end use of the fabric material, any number of holes 3102 can be cut (e.g., a single opening for both nostrils, an additional opening for the mouth, etc.). These holes 3102 can be cut into the fabric material 3130 before or after the first fold. The order in which the single (i.e., the first) fold and the cuts are formed does not substantially affect the presence of creases and / or wrinkles.

[0637] For details, please refer to the following: Figure 52The fabric material shown is used only in a nasal mask, with each hole 3102 being elongated and formed in a generally rectangular shape, although other shapes (e.g., circles, triangles, etc.) may be used in other examples. The holes 3102 may be separated by strips of material that can be formed as bridging portions 3104, although the bridging portions 3104 may also be formed independently of the holes 3102. If more than two holes 3102 are cut into the fabric material 3130, multiple bridging portions 3104 may exist. Creating more bridging portions 3104 may be useful when additional holes are needed, and / or if the fabric material 3130 is large (e.g., so that it does not bend despite having a single bridging portion 3104). As described above, the patient's nose (e.g., their nasal protuberance) can contact the bridging portion 3104, and the bridging portion 3104 can limit the patient's nose from extending into the inflation chamber 3200.

[0638] like Figure 53 As shown, once around the first axis 11000 (e.g., as Figure 53 The initial fold (shown horizontal axis) has been made, and the hole 3102 has been cut, so the bridging portion 3104 (second fold) can be folded around the second axis 12000, which is parallel to (or collinear with) the first axis 12000. In the example shown, the bridging portion 3104 is flipped downwards in sequence (as shown). Figure 53 As shown), in order to clear the space between the paired holes 3102. In other words, a positive arch curvature (e.g., as shown) is applied to the bridging portion 3104. Figure 53 As shown in the figure, the first fold has a negative arch curvature.

[0639] In some forms, once the bridging portion 3104 is folded, a space 3180 is created between the holes 3102. Specifically, the holes 3102 can be vertically oriented (e.g., as shown in the image). Figure 53 As shown), and space 3180 is oriented along the first axis 11000. In other words, each hole 3102 is substantially perpendicular to the first axis 11000, and space 3180 exists between the openings of each hole 3102. The width of space 3180 substantially corresponds to the width between the patient's nasal ala or nasal ridges. In other words, the width of space 3180 is large enough to accommodate the patient's nose and to allow the patient's nostrils to be substantially aligned with the holes. When the nose is located within the space, the apex of fabric material 3130 (i.e., created by the first fold) will contact the patient near the nasolabial fold.

[0640] like Figure 54As shown, once the bridging portion 3104 has been folded around the second axis 12000, the material can be rolled up to maintain its "flipped" orientation. Rolling up can be a method of selectively applying tension to a portion of the fabric membrane 3130 without applying tension to the entire fabric membrane 3130. Other techniques for selectively applying tension can be similarly combined with or instead of rolling up. The bridging portion 3104 is maintained such that it no longer has a first curvature 10000 around the first axis 11000. For example, the bridging portion 3104 may not have a significantly positive arched curvature (e.g., the bridging portion 3104 at...). Figure 54 The curvature amplitude in can be smaller than that in Figure 53 The curvature amplitude in the bridging portion 3104 may have zero curvature, etc., but does not have a negative arch curvature compared to the rest of the fabric material 3130 (e.g., when using the pad assembly 3105). In other words, after curling, the curvature in the bridging portion 3104 differs from that of the rest of the fabric material 3130 (e.g., in size and / or orientation).

[0641] In some examples, the bridging portion 3104 is curled such that only the material forming the bridging portion is stretched (i.e., curling may not apply tension to the rest of the fabric membrane 3130). Specifically, the length of the bridging portion 3104 is folded relative to itself to reduce the total exposed length. The tension in the fabric including the curled bridging portion 3104 is greater than the tension in the surrounding fabric that is not curled. Therefore, the surface of the bridging portion 3104 can be substantially flat and / or can have minimal curvature (e.g., when the curvature about the first axis 11000 is maintained through the rest of the fabric material 3130). The fold in the bridging portion 3104 can be substantially central, such that the length of the material on either side of the fold line is substantially equal, although one side may be longer than the other. Although curling creates tension, the bridging portion 3104 may still be able to flex relative to the hole 3102 (e.g., due to the free-state characteristics of the fabric). The curled bridging portion 3104 can be similar to the uncurled bridging portion 6106, because both are under tension but also retain their free material properties.

[0642] In other examples, other methods of applying tension can be used to create the taut bridging portion 3104, and / or tension can be applied to other locations of the fabric membrane 3130.

[0643] In some examples, the resulting length of the bridging portion 3104 after curling affects the size of the aperture 3102. For example, if the available length remains large (i.e., the curled length is small), the aperture 3102 remains large. In other words, there is a direct relationship between the length of the curled bridging portion 3104 and the size of the aperture 3102. When the length of the bridging portion 3104 decreases (i.e., due to the increase in the curled length), the curled bridging portion reduces the size (e.g., circumference) of each aperture 3102. The length of the bridging portion 3104 can be adjusted based on the size of the patient's nose (e.g., the bridging portion 3104 can be curled with small, medium, and large diameters to accommodate different sized nostrils).

[0644] In some examples, the bridge portion 3104 remains in its curled state due to ultrasonic welding and / or the application of adhesives (e.g., glue), although any suitable method may be used. Any of these methods can be applied to the unusable length 3184 of the bridge portion 3104. For example, adhesive can be applied to selected portions of the fabric layer of the fabric membrane 3130, and the selected portions can be folded together. In other words, the usable length of the bridge portion 3104 may be substantially free of any applied material. Even after a fixing method has been applied, the curled area of ​​the bridge portion 3104 may still have the aforementioned positive arch curvature.

[0645] In one example, after applying the fixing method, a portion of the unusable portion 3184 of the bridging portion 3104 can be trimmed or cut. Once the fabric membrane 3130 is fully assembled into the seal-forming structure 3100, the unusable portion 3184 will be positioned within the air chamber 3200 and may cause airflow interruption (e.g., and generate noise). Therefore, trimming the unusable portion 3184 can reduce or eliminate any interference.

[0646] like Figures 55 to 57 As shown, once the curling is complete, additional curvature around different axes can be applied to the fabric material 3130. The curled bridging portion 3104 can reduce the total area 3188 affected by the additional curvature. In other words, Figure 55 The affected area 3188 (shown by the shaded line) where the bridging portion 3104 is curled is smaller than Figure 51The affected area 3190 is the area where curling does not occur. Affected areas 3188 and 3190 relate to areas where creases and / or wrinkles may appear due to the introduction of multiple curvatures into the fabric material 3130. When the bridging portion 3104 is curled, the affected area 3188 is substantially close to the fabric 3188. For example, the affected area 3188 may be formed into a substantially rectangular shape, with its edges substantially tangent to the opening 3102. The close proximity of the affected area 3188 to the opening 3102 substantially prevents the formation of creases and / or wrinkles when additional curvature is applied to the fabric material 3130.

[0647] In some examples, a third curvature 30000 is formed in the fabric material 3130 around a third axis 13000. The third axis may extend in a direction substantially perpendicular to the first axis 11000 and the second axis 12000 (although it may also be inclined or sloping). In other words, the third axis 13000 may be a substantially horizontal axis (e.g., as shown in the image). Figures 55 to 57 (As shown). In the example shown, the third axis 13000 is centered on the fabric material 3130 and extends along the bridging portion 3104. The third curvature 30000 may have a substantially saddle-shaped region (e.g., as shown). Figures 55 to 57 (As shown). In other words, the third curvature 30000 can be positively curved and can support the patient's nose after the patient wears the patient interface 3000. This means that when the patient interface 3000 is worn, the fabric layer 10133 is specifically a saddle-shaped region around the third axis 13000. Therefore, the second curvature 20000 and the third curvature 30000 can be curved in the same direction (e.g., two positive curvatures), although they are approximately perpendicular axes and can define different regions (e.g., the second curvature 20000 is dome and the third curvature 30000 is saddle-shaped). When the third curvature 30000 is applied, the first curvature 10000 and the second curvature 20000 remain in their previous curved positions. In other words, the application of the third curvature 30000 (or additional curvature) may not substantially affect the magnitude and / or direction of the previous curvature.

[0648] In some examples, a fourth curvature 40000 may be formed in the fabric material 3130 around a fourth axis 14000, and the fourth curvature 40000 may extend in a direction substantially perpendicular to the first axis 11000, the second axis 12000, and the third axis 13000 (although the fourth axis 14000 may have any relationship with the other axes). In other words, the fourth axis 14000 may be a substantially vertical axis (e.g., as shown in the image). Figure 55 (As shown). In the example shown, the fourth axis 14000 does not intersect with the bridging portion 3104. The fourth curvature 40000 can extend toward the center of the fabric material 3130, and can be as shown... Figure 55 The saddle-shaped area is shown. After the patient wears the patient interface 3000, the fourth curvature 40000 can support the patient's face (e.g., the upper part of their lips).

[0649] In some examples, the fifth curvature 50000 may be formed in the fabric material 3130 around a fifth axis 15000, which extends in a direction substantially parallel to and deviates from the first axis 11000 and the second axis 12000 (although the fifth axis 15000 can have any orientation). In other words, the fifth axis 15000 is a substantially horizontal axis (e.g., as shown in the image). Figure 56 (As shown). In the example shown, the fifth axis 15000 does not intersect with the bridging portion 3104. The fifth curvature 50000 includes an orientation similar to the first curvature 10000 and can be a negative dome curvature (e.g., as shown). Figure 56 (As shown). The first curvature 10000 and the fifth curvature 50000 can have different curvature magnitudes (e.g., the first curvature 10000 can be more negative than the fifth curvature 500000). The fifth curvature 50000 can have a variable curvature because its radius of curvature along the length of axis 15000 may not be constant. For example, since the fifth curvature 500000 and the first curvature 10000 are along substantially parallel axes, changing the radius of curvature of the fifth curvature 50000 can guide the two curvatures 10000 and 50000 together (e.g., blend them into one curvature). The fifth curvature 50000 can have a smaller radius of curvature near its center (e.g., near the intersection with the third axis 13000) and a larger radius of curvature near the edge of the fabric material 3130. Here, the larger radius of curvature of the fifth curvature 50000 can be incorporated into the first curvature 10000 (e.g., near the edge of the fabric material 3130). In other words, as the radius of curvature in the fifth curvature 50000 increases, the fifth curvature 50000 can extend into the first curvature 10000. Mixed curvatures can help provide a smooth surface and limit the possibility of creases and / or wrinkles forming in the curved fabric material 3130.

[0650] In some examples, both the fourth curvature 40000 and the fifth curvature 50000 are included on the fabric material 3130. In other words, the central subnasal point region 3260 of the final seal forming structure 3100 constructed from the fabric material 3130 may include the fourth curvature 40000 and the fifth curvature 50000. These curvatures 40000 and 50000 can work together to seal the composite curvature (e.g., multiple curvatures in multiple directions) of the patient's upper lip. In the example shown, when both the fourth curvature 40000 and the fifth curvature 50000 are included on the fabric material 3130, the fourth curvature 40000 is the dominant curvature of the central subnasal point region 3260. For example, the human head has a natural curvature toward either side. In other words, the upper lip curves to the left and right of the patient's face, from the philtrum to the corner of the mouth. The upper lip may also include curvature about a substantially horizontal axis that is perpendicular to the sagittal plane. However, the distance of this curvature is relatively small (i.e., the distance between the nasal lower respiratory tract and the vermilion border of the upper lip is less than the width of the mouth), and the variance between different patients may be greater (e.g., some patients may have a larger and more defined curvature than others).

[0651] The fourth curvature 40000 will be a larger curvature than the fifth curvature 50000. This could include fabric material 3130 extending around the fourth axis 14000, and the lower edge of fabric material 3130 folded around the fifth axis, such that the fourth curvature 40000 includes more total area on fabric material 3130. However, the curled bridging portion 3104 allows the two curvatures 40000, 50000 to remain in the overlapping area without forming creases and / or wrinkles. Therefore, in some examples, the fifth curvature 50000 may not extend exactly along the fifth axis 15000, but may instead extend along a curved path as it follows the length of the fourth curvature 40000.

[0652] Some patients may have a substantially vertical upper lip region between the subnasal point and the vermilion border of the upper lip, thus potentially lacking curvature along a fundamentally horizontal axis perpendicular to the sagittal plane. In these patients, the fifth curvature 50000 may not cover the curved lip region to be sealed. However, the material of the fifth curvature 50000 may deform into a substantially vertical (e.g., flat) region and still maintain an effective seal on the patient's face. Additionally, the height between the subnasal point and the vermilion border of the upper lip may vary between patients. For example, this distance may be very small. In this example, the fabric material of the fifth curvature 50000 may be able to deform into a tight region and be used as an inlet to effectively seal any height. In other examples, the fabric material can be customized for individual patients, and the curvature and radius of curvature are selected based on the specific patient's facial geometry (e.g., which can be identified using a scan).

[0653] Any number of these curvatures can be applied to a single seal-forming structure 3100 to help enhance the fit of the patient interface 3000 against the patient's face. For example, five of all these curvatures can be applied to a single seal-forming structure 3100. In other examples, only some curvatures can be applied to the seal-forming structure 3100. In other examples, more than five curvatures can be applied to the seal-forming structure 3100. The magnitude and / or direction of the curvature can vary on the individual pad components 3105 (e.g., the fabric membrane 3130 can be customized for an individual patient).

[0654] In some examples, the fabric membrane 3130 can be formed into a shape, and the fabric membrane 3130 can be connected to the transverse support region 3122. In the example shown, the fabric membrane 3130 and the transverse support region 3122 are connected using injection molding, making them integrally formed together. In other examples, the fabric membrane 3130 and the transverse support region 3122 can be connected together in a different manner (e.g., by overmolding). In other examples, the fabric membrane 3130 may not be connected to the transverse support region 3122.

[0655] In some examples, the three-dimensional shape of the fabric membrane 3130 (i.e., generated by multiple curvatures) can assist the injection molding tool in forming the flexible support structure 3120 and / or the air chamber 3200. For example, a bridging portion 3104 folded (e.g., rolled up) about the second axis 12000 may be useful when the fabric membrane 3130 is overlaid into the injection molding tool. Specifically, the rolled-up bridging portion 3104 can serve as a sleeve when the fabric membrane 3130 is placed in the injection molding tool. In other examples, the fabric material 3130 can be bent to fully form the air chamber 3200, thus eliminating the need for injection molding material in the patient interface 3000. In other words, the air chamber 3200 and the sealing formation structure 3100 can be constructed from the fabric material 3130 rather than from silicone or other flexible molding materials.

[0656] like Figure 58 and 59As shown, a material (e.g., silicone) can be molded onto the fabric membrane 3130. This material can be applied to the inner layer 3194 of the fabric membrane 3130 (e.g., layer 10131 coated with an impermeable material) to avoid covering a portion of the fabric on the rear surface (which may come into contact with the patient's face during use). Although in other examples, the material can be applied to the outer layer 3196 of the fabric membrane 3130. The material can extend beyond one end of the fabric membrane 3130 and toward the air chamber 3200 (e.g., the material can be molded such that some of the lateral support regions 3122 do not contact the fabric membrane 3130). When the material is molded onto the fabric membrane 3130, the resulting support structure 3120 can have substantially the same curvature (i.e., size and orientation) as the adjacent fabric membrane 3130 (e.g., to create a substantially smooth and uninterrupted surface). The thickness of the material (i.e., the lateral support regions) can vary along its length. For example, the lateral support regions 3122 can be thicker at the distal end of the fabric membrane 3130. In addition, the total thickness of the overlapping fabric film and material can also be thinner than the adjacent area containing only the molding material (i.e., the lateral support area 3122).

[0657] like Figure 58 As shown, some examples of the patient interface 3000 may include a single-walled lateral support region attached to a fabric membrane 3130. A single wall of silicone material can be molded onto the fabric membrane 3130 to form a support structure 3120 that connects the sealing structure 3100 to the inflation chamber 3200. The outer surface 3195 of the support structure 3120 substantially matches the outer surface 3196 (i.e., the fabric layer) of the fabric membrane 3130 to form a smooth, continuous surface. The inner surface 3197 may have different thicknesses as described above. The silicone material overlaps a portion of the fabric membrane 3130 to form a robust connection without adding unnecessary weight to the patient interface 3000. The silicone material may taper to its minimum thickness at one end of the overlapping region 3199 (e.g., near end 3124). The end of the overlapping region 3199 is spaced apart from the nostril opening 3102 to avoid potential interference (e.g., noise) of pressurized air to the patient's nostrils. The overlapping region 4000 is essentially on the first curvature 10000 and can provide additional support to maintain the proper size of the first curvature 10000.

[0658] like Figure 59As shown, some examples of patient interfaces may include a double-walled support structure 3120 coupled to a fabric membrane 3130. A single layer of silicone material may be molded into the fabric membrane 3130 to attach a seal as described above, with an outer surface 3195 substantially matching an outer surface 3196 of the fabric membrane 3130, and an inner surface 3197 comprising a varying thickness along its length. However, an overlapping region 3199 may extend a different length along the inner surface 3194 of the fabric membrane 3130. Specifically, the overlapping region 3199 may contact a length less than that of the fabric membrane 3130 in the single-walled support structure 3120, as described above. Instead, a portion of the silicone wall 3126 may continue along the length of the fabric membrane 3130 but spaced apart from the inner surface 3194. The second wall 3126 of the support structure 3120 may extend cantilevered from the remainder (i.e., starting from end 3124). The support structure 3120, including the second wall 3126, can extend along a similar total overlap length as the support structure 3120 in the single-wall example. The second wall 3126 can be specifically arranged close to the apex of the first curvature 10000 to provide additional support. The second wall 3126 is stiffer than the fabric membrane 3130, and the second wall 3126 can help maintain the shape of the first curvature 10000 when the fabric membrane 3130 is in contact with the patient's face. If an additional force is applied, the fabric membrane 3130 and the second wall 3126 can deform together.

[0659] After the fabric membrane 3130 is assembled to the support structure 3120, the resulting pad assembly 3105 can be used in the patient interface 3000. Specifically, the patient's face (e.g., the patient's nose) can be placed in the space 3180 so that the nostril opening 3102 is positioned close to the corresponding nostril.

[0660] When the pad assembly 3105 is placed, the patient can align the bridging portion 3104 with their nose. Specifically, when the pad assembly 3105 is worn, the bridging portion 3104 can be guided in an anterior / posterior direction (e.g., the fabric membrane 3130 can be substantially facing upwards). The patient moves the bridging portion 3104 to contact their nose, where the taut material of the bridging portion 3104 presses against the patient's nose (e.g., in the subnasal point region and possibly contacting the columella). The bridging portion 3104 restricts the patient's nose from moving into the cavity 3101, but tension can be applied to the surrounding area of ​​the fabric membrane 3130 when the patient's nose is pressed against the taut material. In other examples, the patient can move their face toward a separated area of ​​the fabric membrane 3130 under tension (e.g., as shown in the image). Figures 26 to 33 As shown, if the entire area of ​​the fabric membrane is under tension.

[0661] When the patient contacts the bridging portion 3104, the patient may also contact the sides 3250 and / or corner regions 3252 of the fabric membrane. The sides 3250 and corner regions are located on areas near the apex of the first curvature 10000 at a third curvature 30000. In other words, the sides 3250 and corner regions 3252 are located on a surface with a saddle-shaped region, facing the center of the pad assembly 3105. A positive curvature may exist between opposing sides 3250. The sides 3250 and corner regions 3252 are also positioned where the fabric membrane transitions to a negative arched curvature (i.e., formed by the first curvature 10000), and can be understood as being at the rear of the pad assembly 3105. This transition region can be understood as the dome region of the sealing portion 3130. The sides 3250 and / or corner regions 3252 contact the outer surface of the patient's nose (e.g., near the patient's nasal alae) and may terminate near the alar points on either side of the patient's nose. In this direction, the nostril opening 3102 is aligned with the patient's nostrils and can effectively deliver pressurized air into the patient's airway. The sides 3250 and / or the corner regions 3252 are generally loose, which allows these regions of the fabric membrane 3130 to better conform to various contours of the patient's face. For example, the sides 3250 and / or the corner regions 3252 may be able to adjust their shape to better conform to the area surrounding the patient's nostrils in order to form a tight seal. When the patient's nose engages with the bridging portion 3104, the sides 3250 and / or the corner regions 3252 may be subjected to tension to maintain the proper shape of the patient.

[0662] like Figure 60 As shown, the fabric membrane 3130 may include an arcuate shape 60000 adjacent to each nostril 3102. The arcuate shape 60000 is also arranged close to the sides 3250 and / or corner regions 3252. The arcuate shape 60000 has a saddle-shaped region in the same direction as the first curvature 10000 (and may also be about the first axis 11000). The arcuate shapes 60000 extend into the space 3180 such that the distance between the arcuate shapes 60000 can be the narrowest distance between the opposing sides 3250 and / or corner regions 3252.

[0663] When the patient wears the pad assembly 3105, the nostrils 3102 can be aligned in a generally vertical manner (as described above), and the inner surface of each nostril contacts the corresponding arch 60000. In other words, each arch 60000 is configured to contact the inner surface of each corresponding nasal ala. Since the patient's nose also contacts the bridging portion 3104 of the fabric membrane 3130, each nostril opening 3102 completely surrounds each nostril.

[0664] like Figure 61As shown, once each bow 60000 contacts the inner surface of the corresponding nostril, the bow 60000 flips to a concave direction (i.e., a positive dome curvature relative to the inner surface of the corresponding nostril). Although the curvature of the bow 60000 can point in different directions, this is similar to what happens in the bridging portion 3104. For example, each bow 60000 can move along the first axis 11000 toward its respective inflation chamber connector 3204. In this orientation, each nostril opening can have a generally teardrop shape.

[0665] When the bow shape 60000 is flipped (i.e., from negative dome curvature to positive dome curvature), the bow shape 60000 can wrap around the flank of each nostril. In other words, each bow shape 60000 surrounds the outer periphery of the corresponding nostril. The conformability of the fabric membrane 3130 allows the bow shape 60000 to adjust to the shape of the patient's nasal rim to form a seal sufficient to maintain therapeutic pressure within the inflatable chamber 3200.

[0666] Once the pad assembly 3105 is correctly positioned, pressurized air can be supplied to the patient. The compliance of the fabric membrane 3130 and the fact that the exterior is initially relaxed (e.g., contrary to being taut like a bridging section) allow the seal-forming structure 3100 to form a dynamic seal as pressurized air fills the cavity 3101. The dynamic seal allows the pad assembly to move slightly across the patient's nose while still maintaining the pressurized cavity 3101 and delivering pressurized air to the patient's airway. For example, the bow-shaped 60000 may be able to move slightly against the flange without losing its seal.

[0667] Additionally, the third curvature 30000, the fourth curvature 40000, and / or the fifth curvature 50000 can provide further assistance in maintaining the position of the sealing structure 3100 and enhancing patient comfort. For example, the third curvature 30000 may have a saddle-shaped region relative to the patient and may contact the patient's subnasal point region along the columella (e.g., via a positive curvature). The third curvature 30000 may not extend to the patient's nasal protuberance, leaving it exposed. The third curvature 30000 may be disposed in the nasal protuberance region 3270 of the fabric membrane 3130. The fourth curvature 40000 may have a saddle-shaped region relative to the patient and may (e.g., via a positive curvature) contact the patient's supralipal region. Thus, the fourth curvature 40000 extends in the lateral (left / right) direction when worn by the patient and may also extend substantially along the width of the mouth. The fifth curvature 50000 may have a negative dome curvature relative to the patient's supralipal region. In other words, the fifth curvature 50000 bends away from the patient's upper lip and does not support it. The fourth curvature 40000 and the fifth curvature 50000 can contact substantially the same area of ​​the patient's face, and one or both can be included on a given fabric membrane 3130. The fourth curvature 40000 and / or the fifth curvature 50000 can be positioned in the central subnasal point region 3260 of the fabric membrane 3130. The fifth curvature 50000 can create a "pillow" and / or "airbag" effect on the patient. In other words, due to the expansion of the fabric membrane 3130 by pressurized air, the negative arch curvature of the fifth curvature provides additional cushioning and / or comfort to the patient relative to the patient's upper lip during use.

[0668] Although the above description is specifically for the nose pads, it also applies to the aforementioned patient interfaces 9000, 21000, 23000, and 25000. Additional descriptions for full-face pads are described below.

[0669] 5.3.4.1.1.1 Full-face mat

[0670] Aside from the steps described above, the manufacturing and assembly of a full-face pad differs from that of a nasal pad because a full-face pad requires sealing an additional area around it (i.e., the patient's nostrils and mouth). Therefore, because the overall size of a full-face pad is larger than that of a nasal pad, additional surface area is required for the fabric membrane 10135, and additional surface area is required for the support structure 6120 (e.g., silicone material).

[0671] Figures 22 to 39The patient interfaces shown are assembled by placing two fabric membranes 10135 into a molding tool, and then molding a flexible material (e.g., silicone) onto the fabric membranes 10135 to form patient interfaces 6000, 9000, 21000, 23000, and 25000. In these examples, the two fabric membranes 10135 have different shapes to seal against specific areas of the patient's face (although a single fabric membrane 10135 may be used). As described above, the first fabric membrane 10135 (i.e., for forming the first sealing portion 6131) has a circular shape, and the second fabric membrane 10135 includes a U-shape or a C-shape (e.g., see...). Figure 33 ), or circular or ring-shaped (for example, see Figure 33-1 The fabric membranes 10135 are substantially flat (e.g., having a two-dimensional shape) before being placed into the mold. Once placed in the mold, the two fabric membranes 10135 are slightly spaced apart from each other (e.g., through gap 21190). In some examples, the mold holds the fabric membranes 10135 in a partially flat position when a flexible material (e.g., silicone) is introduced into the mold (e.g., patient interface 6000). In some examples, the mold introduces curvature into the fabric membranes 10135 and holds the fabric membranes 10135 in their curved shape when a flexible material (e.g., silicone) is introduced into the mold (e.g., patient interfaces 9000, 21000, 23000, 25000). The curvature introduced into the fabric membranes 10135 by the mold can cause the bridging portion (e.g., 9106) to fold itself. As the flexible material is introduced into the mold and hardens, it holds the two flexible fabric membranes 10135 together. After the molding process is complete, the bridging portion 9106 can be curled to remove slack on the fabric membrane 10135. Alternatively, the bridging portion 9106 can be curled before the fabric membrane 10135 is placed in the mold. This can apply pre-deformation to the fabric membrane 10135 (e.g., the fabric membrane 10135 is deformed before being positioned in the mold and has additional curvature that imparts to the remainder of the fabric membrane 10135). Since the fabric membrane 10135 is held in a taut position by the mold, the bridging portion 6106 may not need to be curled and can be substantially flat in the transverse direction. The bridging portion 6106 can be under tension without curling and can provide substantially the same benefits as a bridging portion with curling. As previously mentioned, since the first sealing structure 6131 may not include complex curvatures, it may be easier to manufacture the fabric membrane 10135 into the first sealing structure 6131, as opposed to the first sealing structure on another patient interface (e.g., 9000).

[0672] By using two separate fabric membranes 10135 to form the patient interface (e.g., 9000, 21000, etc.), overlapping of the fabric materials 10135 can be avoided. In particular, overlap can be a problem when attempting to impose complex curvatures onto large sheets of fabric membrane 10135, as longer curvatures are possible, potentially leading to more opportunities for the fabric membrane 10135 to fold itself. Since the patient interface 6000 does not include complex curvatures, the likelihood of overlap of the fabric materials 10135 is lower. However, using two separate fabric materials 10135 allows the patient interface 6000 to include a substantially flat surface of a first sealing structure 6131 oriented in a first direction, and a substantially flat surface of a second sealing structure 6132 oriented in a second direction. In other words, because the patient interface 6000 is composed of separate fabric membranes 10135, the separate fabric membranes 10135 can be positioned in different orientations for better conformation to the patient's face.

[0673] One approach to address the overlap problem is to stack multiple fabric membranes 10135 on top of each other to create a complex curvature (e.g., by forming an overlap of a few millimeters with two or more fabric membranes 10135), while reducing the stress experienced in each fabric membrane 10135 (e.g., compared to a single fabric membrane 10135). However, leakage may occur in the overlap area, which could reduce the seal quality in the final patient interfaces 9000, 21000, etc.

[0674] If two separate fabric membranes 10135 are used but not overlapped, the likelihood of a single fabric membrane 10135 folding itself is reduced due to the reduced length of each curve. Furthermore, since the overlapping interfaces of the fabric membranes 10135 have been removed, the possibility of leakage can be reduced even when the fabric membranes 10135 overlap.

[0675] Two spaced-apart fabric membranes 10135 are used, and flexible material can be molded in the space between the two fabric membranes 10135. As shown, this space can be relatively small (e.g., to reduce contact between the patient's skin and the support structures 9120, 21120, etc.). As a result, this may make it difficult to mold this section of the patient interface (e.g., 9000, 21000, etc.) (e.g., because the fabric membranes 10135 must be precisely positioned, the flexible material must fill the space without covering the fabric layer 10133, etc.), but may increase the likelihood that the final patient interface (e.g., 9000, 21000, etc.) does not include creases formed due to the application of complex curvatures on the fabric membranes 10135. A similar principle can also apply to the patient interface 6000 even if there is no complex curvature in the first sealing portion 6131.

[0676] In this example, there is a direct trade-off between ease of manufacture and full textile contact. For example, Figure 35 The patient interface 9000 shown (or Figure 33 The patient interface (6000) in the middle may be more than Figure 33-1 The patient interface 21000 shown is easier to manufacture (e.g., because liquid materials may not be able to be molded into very small spaces). However, in Figure 35 In the example shown, the upper part of the patient's lip (e.g., near the philtrum) will contact a larger surface area of ​​the support structure 9120 (i.e., not the fabric layer 10133), which may have a similar surface area to... Figure 33-1 The patient interface 21000 has relatively low patient comfort compared to other interfaces.

[0677] Figure 33-2 The example of patient interface 23000 shown can be used to try to balance in Figure 34 Patient interface 9000 (or Figure 33 (of 6000) and Figure 33-1 The problem observed in the patient interface 21000. In other words, Figure 33-2 The patient interface 23000 can attempt to reduce manufacturing complexity without sacrificing patient comfort. To this end, the second fabric membrane 10133 may include a U-shape or a C-shape (e.g., similar to...). Figure 33 and 35 (Example shown). The U-shaped fabric membrane 10135 includes an outer edge 23180 forming a portion of the outer periphery of the lower sealing portion 23130b, and an inner edge 23182 forming a portion of the oral cavity portion orifice 23104. Figure 33-2 The first fabric membrane 10135 of the upper sealing portion 23130a can be larger than the forming Figure 33-1The first fabric membrane 10135 of the upper sealing portion 21130a is aligned with the inner edge 23184 of the second fabric membrane 10135. In other words, unlike the support structure 23120, the oral cavity portion orifice 23104 comprises the fabric membrane 10135 essentially throughout its entire periphery. Since the fabric membrane 10135 is a separate sheet, gaps 23190 filled with flexible material can still exist between the various components (i.e., between the upper sealing portion 23130a and the lower sealing portion 23130b). These gaps 23190 are generally longitudinal (e.g., left / right) and extend at least between the outer edge 23180 and the inner edge 23182. The gaps 23190 can be small enough that the patient's comfort is not affected by their presence (e.g., the patient may not feel the support structure 23120 between the sealing portions 23130a, 23130b, but will feel as if only the fabric material is in contact with the area around their mouth). In some examples, the gaps 23190 can be so small that the patient may not be able to detect their presence.

[0678] In the mold, the fabric membrane 10135 is arranged as described above, and a flexible material is introduced into the mold to form the patient interface 23000. Because the lower edge 23184 of the first fabric membrane 10135 extends to the inner edge 23182 of the second fabric membrane, the flexible material is not introduced into the mold in the area between the nostril opening 23103 and the oral cavity portion opening 23104. In other words, the fabric membrane 10135 is the only material configured to contact the fibrous membrane in the supralipal region (e.g., near the philtrum). Even though the flexible material is flexible and movable, the combination of the fabric membrane 10135 and the flexible material reduces the elasticity of the patient interface 23000. For example, during molding, the flexible material may solidify on the inner surface (i.e., within the cavity 23001 of the fabric membrane 10135), increasing the thickness of this area. In use, the patient interface 23000 may be more difficult to bend when the patient's supralipal region contacts this area, which may result in a poor seal (i.e., allowing leakage). By eliminating the need for a support region between the nostril opening 23103 and the oral cavity portion opening 23104, flexible material does not need to flow into this region, and the thickness of the fabric membrane 10135 can remain substantially constant. In the absence of flexible material substantially supporting the fabric membrane 10135 (e.g., as...), Figure 33-1 As shown, the fabric membrane 10135 may be able to stretch to the same thickness as a patient interface made entirely of silicone (e.g., 0.3 mm thick silicone), thus the fabric membrane 10135 can achieve a sealing quality to the patient's face that is substantially the same or similar to that of the entire silicone membrane.

[0679] To fabricate the patient interface 23000, the fabric membrane 10135 can be substantially flat (e.g., having a two-dimensional shape) before being placed into the mold, and can receive complex curvature molds due to its placement. A liquid flexible material can be applied to form the three-dimensional patient interface 23000 (e.g., maintaining complex curvature in the fabric membrane 10135 after removal from the mold). As described above, any curling can be applied before or after the fabric membrane 10135 is placed into the mold.

[0680] like Figure 33-3 As shown, when constructing the sealing portion 25130, a single fabric membrane 10135 can be used to form the patient interface 25000. In other words, a single fabric membrane 10135 is used for sealing around the patient's nostrils and mouth. The sealing portion 25000 includes an upper sealing portion 25130a and a lower sealing portion 25130b. The outer periphery of the sealing portion 25130 is substantially the same as in the example described above. However, in this example, it is not necessary to form a support structure 25120 between the first fabric membrane 10 and the second fabric membrane 10135 to space them apart and connect them together. Therefore, manufacturing may be easier since the fabric membranes do not need to be properly spaced and filled with liquid molding material. Additionally, the entire area of ​​the mouth and / or nose closest to the patient's interface 25000 is formed by the fabric layer 10133. This can help improve patient comfort because the support structure 25120 will not come into contact with the upper part of the patient's lips.

[0681] Using the above-described curling method, even when using a larger piece of fabric film 10135, the possibility of a single piece of fabric film 10135 folding onto itself can be reduced or eliminated (e.g., with...). Figure 33-1 and Figure 33-2 (Compared to the example shown). In particular, curling can reduce or eliminate overlap that occurs in the nose region where more curvature is applied.

[0682] Furthermore, the sealing quality of the resulting patient interface may not be significantly reduced (e.g., compared to...). Figure 33-1 and 33-2 Compared to the patient interface 21000 and 23000). Figure 33-3 The fabric membrane 10135 may include a fabric layer 10133 backed by an impermeable layer 10131, but the entire fabric membrane 10135 may be unbacked (e.g., it may not be backed by the flexible material of the support structure 25120). The fabric membrane 10135 may be able to stretch by a similar amount as silicone alone (e.g., the impermeable layer 10131 may not significantly reduce the stretchability of the fabric membrane 10135), and thus be able to adapt to various contours along the patient's face (e.g., near the patient's nostrils), which may help form a seal.

[0683] To reduce and / or eliminate leakage when wearing the patient interface 25000, the shape of the fabric membrane 10135 can be modified to better accommodate a larger area of ​​the patient's face and limit leakage (e.g., see...). Figures 33-4 to 33-5 In one example, modifications to the fabric membrane 10135 may include reducing the radius of curvature in the upper sealing portion 25130a. Reducing the radius of curvature creates a deeper pocket or nose radius to accommodate the patient's face. For example, the portion of the upper sealing portion 25130a that accommodates the patient's nose may be narrower, so that the fabric membrane 10135 fits snugly against the patient's nose when the patient's nose contacts the fabric layer 10133 of the sealing portion 25130. This is particularly beneficial for patients with smaller and / or narrower noses who find the sealing portion 25130 too loose to fit properly due to its larger radius of curvature. Because the fabric membrane 10135 is flexible and deformable, patients with slightly larger noses can still use the patient interface 25000 and achieve a tight fit (e.g., to reduce leakage).

[0684] Furthermore, reducing the radius of curvature of the upper sealing portion 25130a can impart a similar shape at the junction between the sealing portion 25130 and the support structure 25120. Since the upper sealing portion 25130a and the support structure 25120 are connected, the support structure 25120 can be pulled in the direction of the deep pocket portion formed in the upper sealing portion 25130a.

[0685] Reducing the radius of curvature of the upper sealing portion 25130a allows for a similar shape to be imparted to the lower sealing portion 25130b, since both the upper sealing portion 25130 and the lower sealing portion 25130b are formed from the same piece of fabric film 10135. This can significantly reduce the curvature at the lower end of the lower sealing portion 25130b (e.g., the area configured to contact the patient's chin) and provide similar benefits to the deeper pocket portion described above.

[0686] In some examples, the radius of curvature can be adjusted about the third axis 13000. In other words, the sides 25250 and / or corner regions 25252 of the patient interface 25000 may be closer together, and the patient may have to push their nose further into the pad assembly 25105 to contact the bridging portion 25106. Alternatively, the radius of curvature about the fifth axis 15000 can be increased, thereby reducing curvature. Increasing the radius of curvature about the fifth axis 15000 helps maintain a deep curvature about the third axis 13000 because the fifth curvature 50000 does not flatten the third curvature 30000 (e.g., because the third curvature 30000 and the fifth curvature 50000 are about non-parallel axes).

[0687] In some examples, the radius of curvature around the third axis can be less than approximately 40 mm. In some examples, the radius of curvature around the third axis can be less than approximately 30 mm. In some examples, the radius of curvature around the third axis can be between approximately 25 mm and approximately 15 mm. In some examples, the radius of curvature around the third axis can be approximately 20 mm. This radius of curvature can be present only in the fabric membrane 10135. By reducing the radius of curvature, the patient's nose can be more tightly secured within the sealing portion, thereby reducing leakage. Reducing the radius of curvature also helps the patient to more accurately position their nose against the patient interface 25000 (e.g., to more accurately align their nostrils with the corresponding nostril openings 25103) because there is less space for lateral movement of the patient's nasal cavity (e.g., sliding and / or displacement) to bring it closer to the patient interface 25000.

[0688] Leakage can also be prevented and / or reduced by reinforcing the sealing portion 25130 and / or the support structure 25120. For example... Figure 33-6 As shown, a support rib 25186 can be added within the cavity 25001 to increase sealing. This locally stabilizes the rigidity of the patient interface and improves the quality of the seal against the patient's skin. In some examples, the support rib 25186 may be included and / or enlarged to increase local rigidity. In some examples, the support rib 25186 is enlarged by adding a second rib 25188. In some examples, the support rib 25186 is enlarged by increasing its width. In some examples, the support rib 25186 is enlarged by increasing its length.

[0689] In one example, a support rib 25186 is molded into a patient interface 25000 within a cavity 25001, and a second rib 25188 is molded to one end of the support rib 25186. One end of the support rib 25186 may contact the impermeable layer 10131 of the membrane. A sealing portion 25130 and the second rib 25188 may be molded to the other end of the support rib 25186. The support rib 25186 and the second rib 25188 may together form an L-shape. The support rib 25186 may intersect the second rib in an approximately perpendicular relationship. The second rib 25188 may be parallel to at least a portion of the sealing portion 25130. In the example shown, the patient interface may include two support ribs 25186 (although any number is acceptable), each of which is connected to the sealing portion 25130. The inner end of each support rib 25186 may extend from the inner edge of the sealing portion 25130 between approximately 2 mm and approximately 8 mm (e.g., a free end near the opening of the cavity 25001). Each second rib 25186 may not extend further to avoid obstructing airflow through the nostril 25103. A single second rib 25188 may extend between two support ribs 25186. The ends of the second ribs 25188 may be connected to the impermeable layer 10131 of the sealing portion 25130, such that the second ribs 25186 follow an arcuate pattern. In other examples, the second ribs 25188 may not extend beyond the furthest support rib 25186. In other words, the distance between the support ribs 25186 may be approximately the length of the second ribs 25188.

[0690] The inclusion of a second rib 25188 can improve the seal of the patient interface 25000 when worn by a patient. Specifically, the stiffness of the sealing portion 25130 can be increased. For example, the stiffness of the portion of the sealing portion 25130 configured to contact the upper lip can be increased due to the support ribs 25186 and / or the second rib 25188. The distance between the support ribs 25186 and the number of support ribs 25186 may affect the increase in overall stiffness. In other words, increasing the number of support ribs 25186 and / or decreasing the distance between adjacent support ribs 25186 will increase the stiffness of the sealing portion 25130. The second rib 25188 can act as a stop and helps limit the compression of the support ribs 25186 (e.g., due to contact with the patient's face). Increased stiffness can help maintain shapes with different curvatures and provide an ideal fit for the patient. For example, ribs 25186 and 25188 help maintain various radii of curvature of the sealing portion 25130 and limit the occurrence of creases or folds in order to limit leakage.

[0691] In one example (for example, see...) Figure 33-7 The support rib 25186 is molded into the patient interface 25000 within the cavity 25001, and its length is greater than that of the support rib 25186. Figure 33-6The length shown is long. A support rib 25186 with or without a second rib 25188 can be molded with or without a larger width. Increasing the width of the support rib 25186 reduces the likelihood of the support rib 25186 bending when the patient wears the patient interface 25000. The stiffness of the support rib 25186 will be greater, thus reducing the likelihood of the sealing portion 25130 wrinkling and / or folding. Combining the second rib 25188 with a wider support rib 25186 can further increase the stiffness of the sealing portion 25130 compared to including only one of these variations. However, increasing the thickness of the support rib 25186 can specifically increase the stiffness at the location where the support rib 25186 is attached to the sealing portion 25130 (i.e., a local increase in stiffness), unlike the second rib 25188, which increases the stiffness over a larger area surrounding the sealing portion 25130.

[0692] In one example, support rib 25186 is molded into patient interface 25000 within cavity 25001, and its length is greater than that of... Figure 33-7 The length shown is long. The longer support rib 25186 may be molded with or without a second rib 25188, and / or with or without a wide support rib 25186. In some examples, the length of each support rib 25186 may be increased between approximately 0.1 mm and approximately 8 mm. In some examples, the length of each support rib 25186 may be increased between approximately 0.5 mm and approximately 5 mm. In some examples, the length of each support rib 25186 may be increased between approximately 1 mm and approximately 3 mm. In some examples, the length of each support rib 25186 may be increased by approximately 2.5 mm. The extended support rib 25186 may provide additional support for a portion of the sealing portion 25130 along a third curvature 30000 that may contact the upper lip of the patient.

[0693] Leakage can also be prevented and / or reduced by changing the shape of the patient interface 25000 (see, for example, [reference]). Figure 33-8 (and 33-9). For example, the shape and / or contour of the sides 25250 and / or corner regions 25252 of the sealing portion 25130 can be adjusted to better fit the patient's face (e.g., near the corners or alar regions of the nose). The shape of the sealing portion 25130 can be changed by altering the shape of the support structure 25120. Since the support structure 25120 helps determine the location of the sealing portion 25130, the shape of the support structure 25120 will change with the shape of the sealing portion 25130.

[0694] In some examples, the first curvature 10000 can be adjusted to help provide an improved seal for the patient. Specifically, the amplitude of the first curvature 10000 can be more negative about the first axis 11000 (i.e., more negative than in the previously described examples). As described above, the sides 25250 and / or the corner regions 25252 are positioned on the sealing portion 25130, close to the transition between the positive curvature (i.e., the third curvature) about the third axis 13000 and the first curvature 10000. By increasing the amplitude of the first curvature 10000, the dome shape can become more pronounced (e.g., the curvature becomes steeper). This can reduce the width between the opposing sides 25250, which can provide a tighter fit for the patient wearing the patient interface 25000, which in turn can restrict movement of the patient's nose toward the sealing portion 25130.

[0695] The shape of the support structure 25120 can also be adjusted to limit and / or prevent leakage. Since the support structure 25120 is molded to the sealing portion 25130, changing the shape of the support structure 25120 (e.g., molding it with a greater degree of negative curvature) can also give the sealing portion 25130 a shape change. This can be achieved... Figure 33-9 Specifically, it shows the sealing portion 25130-1 after the shape change and the sealing portion 25130 before the shape change. Creating a large dome shape in the support structure 25120 will produce similar effects to those described above regarding the sealing portion 25130.

[0696] like Figure 33-10 As shown, leakage can be prevented and / or limited by raising the top vector of the patient interface 25000. Similar to... Figure 24 The patient interface 9000 shown, and the positioning and stabilizing structure 9300 can engage the patient interface 25000 at four contact points (i.e., two on each side) with the inflation chamber 25200 and / or the sealing formation structure 25100. For example, clips 9301 and catheters 9900 (see, for example, see...) Figure 24 The pad assembly 25105 is connected to the left and right sides. When worn, the patient can adjust the length of the upper strap 9302 and / or the catheter 9900 can be extended (e.g., due to the elastomeric material, due to the accordion-style flap, etc.) to pull the pad assembly 25105 against the patient's face. The pulling force from the positioning and stabilizing structure 9300 helps to seal the sealing portion 25130 (see, for example...). Figure 33-3 A seal is formed between the face and the patient's face.

[0697] By altering the position of the clip 9301 and / or catheter 9900 connected to the pad assembly 25105, the sealing force from tension can be improved. For example, changing the position of the vector can allow for a tighter seal against the patient's face. This can be achieved by further separating the connection points of the clip 9301 and the catheter 9900 (i.e., on either side). In one example, the connection point for the catheter 9900 is... Figure 24 The example shown is positioned higher (e.g., closer to the nasal protuberance when worn). This higher position of the catheter 9900 connecting to the pad assembly 25105 allows the force provided by the catheter 9900 to act more directly on the nose portion of the pad assembly 25105 (e.g., closer to the nostril opening 25103). Raising the catheter connection point also allows the force applied by the catheter to be more localized around the nostril 25103 (e.g., allowing a larger force component to be applied at that location). Because a patient's nose includes various contours, concentrating most of the force from the catheter 9900 allows the sealing portion 25130 to more accurately conform to the patient's facial geometry.

[0698] like Figure 33-10 As shown, the upper vector can rise from a first height H1 to a second height H2. The second height H2 is closer to the nostril opening 25103 than the first height H1. In some examples, the distance between the first height H1 and the second height H2 is at least about 0.5 mm. In some examples, the distance between the first height H1 and the second height H2 is between about 1 mm and about 10 mm. In some examples, the distance between the first height H1 and the second height H2 is between about 2 mm and about 8 mm. In some examples, the distance between the first height H1 and the second height H2 is between about 3 mm and about 5 mm. In some examples, the distance between the first height H1 and the second height H2 is about 4 mm.

[0699] like Figure 33-11 As shown, leakage can be prevented and / or limited by applying insert 25194 to the surface of pad assembly 25105. In some examples, insert 25194 may be made of foam material and may be disposed on the outer surface of sealing portion 25130 (e.g., in contact with fabric layer 10133). In addition to and / or instead of being disposed on sealing portion 25130, insert 25194 may also be disposed on the surface of support structure 25120.

[0700] Insert 25194 can be positioned anywhere along the pad assembly 25105. In the example shown, insert 25194 is positioned discontinuously throughout the pad assembly 25105 and can be specifically positioned in locations prone to leakage. For example, this could be near the sides 25150 and / or the corner regions 25252, which are configured to contact the nasal region of the patient's face. The insert may be able to deform to the complex facial geometry of the patient to form a tighter seal and reduce gaps where air can escape. In some examples, the foam is not exposed to the environment when the patient wears the pad assembly 25105. Therefore, insert 25194 provides additional material to tighten the fit in certain areas but does not provide a channel through itself where air could leak.

[0701] In some examples, the insert 25194 is permanently attached to the pad assembly 25105. For example, the insert 25194 may be glued or otherwise secured to the surface of the pad assembly 25105 so that the patient cannot remove the insert 25194 without potentially damaging the pad assembly 25105. In other examples, the insert 25194 may be removable so that the patient can position it in various locations or remove the insert 25194 completely.

[0702] The above and Figures 33-1 to 33-11 Any combination of the leak prevention and / or reduction examples described herein can be used in a single pad assembly 25105. Including several of the above examples can provide further improvements in preventing and / or limiting leaks. However, some patients may not have experienced pressurized air leaks, and for any of these examples, pad assembly 25105 may not be necessary. For example, patients with larger noses may find the unmodified pad assemblies 6105 or 9105 more secure, or their noses may fit too tightly with the modified pad assembly 25105.

[0703] 5.3.4.1.2 Example of fabric membrane

[0704] The following are exemplary properties and structural arrangements of fabric composite materials used as fabric membrane materials.

[0705] 5.3.4.1.2.1 Fabric Composite Structure

[0706] Various combinations of fabric materials and diaphragm / membrane layers can be used. In one example, a three-layer arrangement is used, comprising a thermoplastic polyurethane (TPU) membrane disposed between two fabric layers (e.g., nylon, a nylon and polyester blend, a nylon and spandex blend, a polyester and spandex blend, or a nylon / polyester / spandex blend). Additional fabric layers are required to protect the TPU membrane from breakage (e.g., during cleaning).

[0707] In another example, a two-layer arrangement is used, which includes a fabric (e.g., nylon, a nylon and polyester blend, a nylon and spandex blend, a polyester and spandex blend, or a nylon / polyester / spandex blend) having a silicone layer (e.g., coated thereon). This composite material can be cheaper than the three-layer arrangement discussed above because only one layer of fabric is required.

[0708] In another example, a fabric material (e.g., microfiber or polyurethane material) can be coated with a polyurethane film to form a two-layer arrangement.

[0709] 5.3.4.1.2.2 Fabric Materials

[0710] As mentioned above, a variety of fabric materials can be used to form the sealing parts, such as nylon, polyester, spandex, nylon and polyester blends, nylon and spandex blends, polyester and spandex blends, nylon / polyester / spandex blends, fibers, or polyurethane.

[0711] In one example, nylon is used. Because nylon is softer than polyester, it provides comfort for the patient. Nylon is also more durable than polyester, thus extending its lifespan and overall durability. Furthermore, nylon has a higher melting point than polyester, allowing it to withstand higher-temperature manufacturing conditions.

[0712] In another example, a blend of nylon and polyester is used. This material may be more ideal because the addition of polyester makes it less absorbent of moisture, thus reducing irritation to the patient. The blend of nylon and polyester is also cheaper than nylon alone.

[0713] 5.3.4.1.2.3 Total thickness of fabric composite materials

[0714] Thicker fabric films (e.g., 0.5 mm) may be stronger and offer less fragility. These fabric films may also be easier to handle during manufacturing because they are less likely to be flipped.

[0715] Medium-thickness ranges (e.g., 0.35 mm to 0.45 mm) can provide a flexible and lightweight structure that is relatively easy to handle during manufacturing and can provide greater comfort to patients compared to thicker fabric membranes.

[0716] Thinner fabric membranes offer a very lightweight structure that provides a soft and comfortable feel for patients, but they are less durable compared to thicker fabric membranes.

[0717] 5.3.4.1.2.4 Knitted Structure

[0718] The fabric material of the fabric membrane can have, for example, a weft-knitted structure or optionally a warp-knitted structure. A weft-knitted and / or warp-knitted structure can be considered an elastic fabric. Weft-knitted fabrics may be more desirable because they provide greater elasticity to the material compared to warp-knitted fabrics. This can be advantageous because it can provide greater comfort to the patient by stretching when the fabric membrane is in contact with the patient's face, thereby reducing the force exerted on the patient's face by the fabric membrane.

[0719] In one example, the weft direction (the direction of the horizontal 80) can extend in the nose width direction of the fabric membrane because the weft direction can have greater elasticity or stretch. Alternatively, the weft direction can extend in the nose length direction (vertical direction).

[0720] In addition, weft knitting is better suited for producing relatively thin materials, such as those disclosed in this article. Moreover, compared to warp knitting, weft knitting is generally significantly less expensive.

[0721] However, in some cases, warp knitting may be ideal because it provides less shrinkage than weft knitting.

[0722] In some examples, the fabric membrane may include any knitted structure that allows the fabric membrane to stretch.

[0723] In other examples, fabric membranes may include different structures (e.g., woven), but can still be considered as elastic fabrics.

[0724] 5.3.4.1.2.5 Knitting Machine

[0725] Weft-knitted materials can have a single plain weave structure, providing a process front and process back with different appearances. A single plain weave structure can be formed using a set of needles, providing knit stitches on the process front (front) and purl stitches on the process back. In one example, the process front can form the outer surface of a fabric membrane, and an impermeable me...

Claims

1. A patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to a patient's nasal inlet and a patient's mouth inlet, wherein the patient interface is configured to maintain a therapeutic pressure within a range of 4 cmH2O to 30 cmH2O above the ambient air pressure during use throughout the patient's respiratory cycle while the patient is asleep, in order to improve sleep-disordered breathing; the patient interface comprising: An air chamber, which at least partially forms a cavity pressurizable to a treatment pressure at least 6 cmH2O higher than ambient pressure, the air chamber including an air chamber inlet port, the size and structure of which are designed to receive an airflow at the treatment pressure for the patient to breathe; as well as A sealing structure is configured and arranged to maintain the therapeutic pressure in the cavity throughout the patient's respiratory cycle during use; The sealing structure includes a flexible silicone support structure and a fabric membrane, the fabric membrane being configured and arranged to form a seal with regions of the patient's face surrounding the patient's nasal inlets and mouth inlets, the fabric membrane comprising: A nose portion, shaped and configured to form a seal with the underside of the patient's nose during use, the nose portion including a pair of nasal openings and a bridging portion, the pair of nasal openings configured to deliver airflow to the patient's nostrils, the bridging portion extending between the pair of nasal openings, and... The oral cavity portion is configured to at least partially surround the entrance to the patient's mouth. The fabric membrane comprises a fabric material configured to come into contact with the patient's face during use, the fabric material being a single continuous sheet material. Wherein, at least the nasal portion of the fabric membrane extends radially inward beyond the flexible silicone support structure, and the nasal portion of the fabric membrane is configured to press against the patient's face during use, such that the patient's nose is not contained within the cavity, and The nose portion, which is configured to form a seal with the bottom surface of the patient's nose, comprises a three-dimensional shape having multiple curvatures.

2. The patient interface as described in claim 1, wherein, The oral cavity portion includes an oral cavity opening configured to be positioned adjacent to the patient's mouth during use.

3. The patient interface as described in claim 2, wherein, Each nasal opening is configured to be one of the patient's nasal openings when in use.

4. The patient interface as described in claim 1, wherein, The nose is configured to, in use, form a seal with the bottom surface of the patient's nose at or below the nasal protuberance and to contact the patient's subnasal point and / or columella.

5. The patient interface as described in claim 1, wherein, The fabric membrane is airtight.

6. The patient interface as described in claim 1, wherein, The bridging portion restricts the patient's nose from entering the cavity during use.

7. The patient interface as claimed in any one of claims 1 to 6, wherein, The at least one inflation chamber inlet port includes two inflation chamber inlet ports formed on each side of the inflation chamber.

8. The patient interface as claimed in any one of claims 1 to 6, wherein, The flexible silicone support structure holds the fabric membrane, thereby forming the three-dimensional shape at the nose of the fabric membrane.

9. The patient interface as described in claim 8, wherein, The flexible silicone support structure includes at least one support rib, which engages with the oral cavity portion within the cavity of the air chamber.

10. The patient interface as described in claim 9, wherein, The flexible silicone support structure further includes a second rib disposed within the cavity, wherein at least one support rib extends between the second rib and the oral cavity portion.

11. The patient interface as claimed in any one of claims 1 to 6, wherein, The fabric membrane forming the sealing structure is bent around at least two non-parallel axes to form the three-dimensional shape.

12. The patient interface as claimed in claim 11, wherein, The oral cavity portion is curved around the at least two non-parallel axes.

13. The patient interface as claimed in any one of claims 1 to 6, wherein, The fabric membrane includes a silicone resin layer bonded to the fabric material, the silicone resin layer having impermeable properties.

14. The patient interface as claimed in claim 1, wherein, The fabric membrane is attached to the flexible silicone support structure along its outer periphery, such that the fabric membrane extends radially inward in a direction away from the flexible silicone support structure.

15. The patient interface as described in claim 14, wherein, The air chamber comprises silicone resin and is formed as a one-piece silicone resin structure with the flexible silicone resin support structure.

16. The patient interface as described in any one of claims 1 to 6, wherein, In use, the patient's nose and upper lip are configured to contact only the fabric membrane.

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