Patient interface

Abstract

A patient interface may include an inflation chamber pressurizable to a treatment pressure, a seal-forming structure constructed and arranged to form a seal with a region of a patient's face surrounding an airway entrance of the patient, a positioning and stabilizing structure providing a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, and a vent structure allowing continuous flow of gas exhaled by a patient from the interior of the plenum chamber to the surroundings, where the patient interface is configured to uncover the mouth of the patient during treatment, where the seal forming structure comprises two lateral support regions and an intermediate region, each lateral support region is located outermost of the seal forming structure, the intermediate region is located between the lateral support regions, the aperture passes through the intermediate region, and wherein the lateral support regions are thicker than the intermediate region.

Description

[0001] This application is a divisional application of the patent application with application number 201980065877.X, application date August 20, 2019, and invention name “Patient Interface”. The patent application with application number 201980065877.X is the Chinese national phase application of the PCT application with application number PCT / AU2019 / 050873.

[0002] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent Office file or records, but otherwise reserves all copyright rights whatsoever.

[0003] 1 Cross-reference to related applications

[0004] This application claims the benefit of U.S. Provisional Application No. 62 / 764,992, filed on August 20, 2018, the entire contents of which are incorporated herein by reference. 2 Background technology 2.1 Technical Field

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

[0007] 2.2 Description of related technologies

[0008] 2.2.1 Human respiratory system and its disorders

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

[0010] The airway includes a series of branching tubes, which become narrower, shorter and more numerous as the branching tracheae penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the inhaled air and to expel carbon dioxide in the opposite direction. The trachea is divided into the left main bronchus and the right main bronchus, which are eventually divided into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further airway division leads to respiratory bronchioles and eventually to alveoli. The alveolar region of the lungs is where gas exchange occurs and is referred to as the respiratory zone. Referring to "Respiratory Physiology", the 9th edition, published by John B. West, Lippincott Williams & Wilkins in 2012.

[0011] There is a range of breathing disorders. Some disorders can be characterised by specific events, for example, apnea, hypopnea and hyperpnea.

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

[0013] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events including occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway and normal loss of muscle tone in the area of ​​the tongue, soft palate, and posterior oropharyngeal wall during sleep. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. It often leads to excessive daytime sleepiness and may lead to cardiovascular disease and brain damage. Complications are common disorders, 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] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller in which there are rhythmic alternating cycles of boom-and-bust ventilation called CSR cycles. CSR is characterized by repeated hypoxia and reoxygenation of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with repeated arousals from sleep, which leads to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0015] Respiratory failure is a term for a respiratory disorder in which the lungs cannot take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can encompass some or all of the following disorders.

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

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

[0018] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that have certain common features. These diseases include increased resistance to air flow, prolonged expiratory phase of breathing, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: dyspnea on exertion, chronic cough, and sputum production.

[0019] Neuromuscular disease (NMD) is a broad term that covers many diseases and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage, which leads to loss of walking ability, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive types: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within a few years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over many years and only slightly reduces life expectancy (e.g., limb girdle, scapulohumeral and myotonic dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, dysphagia, dyspnea during exercise and at rest, fatigue, drowsiness, morning headaches, and difficulty concentrating and mood changes.

[0020] The chest wall is a group of chest disorders that result in inefficient connections between the respiratory muscles and the thorax. These disorders are usually characterized by restrictive defects and have the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0021] A range of treatments have been used to treat or ameliorate such conditions. In addition, such treatments can be used to prevent breathing disorders in otherwise healthy individuals. However, these treatments have a number of disadvantages.

[0022] 2.2.2 Treatment

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

[0024] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA treated by CPAP can be voluntary, so if the patient finds the device used to provide such treatment to be any one or more of: uncomfortable, difficult to use, expensive, and unsightly, the patient may choose not to comply with the treatment.

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

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

[0027] 2.2.3 Treatment system

[0028] These treatments can be provided by a treatment system or device.Such systems and devices can also be used to screen, diagnose, or monitor a condition without treating it.

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

[0030] Another form of treatment system is a mandibular repositioning device.

[0031] 2.2.3.1 Patient interface

[0032] The patient interface can be used to engage the respiratory apparatus to its wearer, for example, by providing an air flow to the entrance of the airway. The air flow 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, for example, an area of ​​the patient's face to facilitate the delivery of gas at a pressure that is sufficiently different from the ambient pressure (e.g., approximately 10 cmH2O positive pressure relative to the ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cmH2O to the airway.

[0033] Certain other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain a suitable pressure. Mask systems for underwater swimming or diving may be configured to prevent water from flowing in from high pressure outside, rather than maintaining air at a higher pressure than the environment inside.

[0034] Certain masks may be clinically disadvantageous to the present technology, for example, if they block airflow through the nose and only allow it through the mouth.

[0035] If certain masks require the patient to insert a portion of the mask structure into their mouth to create and maintain a seal with their lips, this may be uncomfortable or impractical with the present technology.

[0036] Certain masks may not be feasible for use while sleeping, for example, while sleeping on one's side in bed with the head on a pillow.

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

[0038] Due to these challenges, some masks face one or more of the following problems: obtrusive, unsightly, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for a long time or when the patient is not familiar with the system. The wrong size mask may lead to reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed to apply anesthetics are acceptable for their original applications, but for long periods of time (e.g., several hours), such masks are not as comfortable as ideal. This discomfort may lead to reduced patient compliance with therapy. This is even more true if the mask is worn during sleep.

[0039] CPAP therapy is very effective in treating certain breathing disorders, assuming the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Since patients are often advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not clean their mask, which may affect patient compliance.

[0040] While a mask used for other applications (eg, pilots) may not be suitable for treating sleep disordered breathing, a mask designed for treating sleep disordered breathing may be suitable for other applications.

[0041] For these reasons, a diverse field of patient interfaces for delivering CPAP during sleep has emerged.

[0042] 2.2.3.1.1 Sealing structure

[0043] The patient interface may include a seal-forming structure. Since it is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

[0044] The patient interface can be characterized in part according to the design intent of the seal-forming structure to engage with the face when in use. In one form of patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left nostril and a second sub-portion that forms a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils when in use. This single element may be designed, for example, to cover the upper lip area and the bridge of the nose area of ​​the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth area when in use, for example, by forming a seal on the lower lip area of ​​the face. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth area when in use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0045] A seal-forming structure that may be effective in one area of ​​a patient's face may not be suitable in another area, for example, because the shape, structure, variability, and sensitive areas of the patient's face are different. For example, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on the patient's nose.

[0046] Certain seal-forming structures may be designed for mass manufacturing so that one design is appropriate, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-manufactured patient interface, one or both must adapt to form a seal.

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

[0048] Another type of seal-forming structure incorporates a sheet seal of thin material positioned around the perimeter 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 forms of seal-forming structures, if the fit between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. In addition, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or bend during use, causing leaks.

[0049] Another type of seal-forming structure may include friction-fit elements, for example, for insertion into a nostril, however some patients find these uncomfortable.

[0050] Another form of seal-forming structure may use an adhesive to achieve a seal. Some patients may find it inconvenient to constantly apply and remove adhesive from their face.

[0051] A series of patient interface seal forming structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

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

[0053] ResMed Inc. manufactures the following products in combination with nasal pillows: SWIFT TM Nasal pillow mask, SWIFT TM II nasal pillow mask, SWIFT TM LT nasal pillow mask, SWIFT TM FX Nasal Pillows Mask and MIRAGE LIBERTY TM Full face mask. The following patent applications assigned to ResMed, Inc. describe examples of nasal pillow masks: International Patent Application WO 2004 / 073778 (which describes other aspects of ResMed, Inc.'s SWIFT™ nasal pillows); U.S. Patent Application 2009 / 0044808 (which describes ResMed, Inc.'s SWIFT™ nasal pillows); TM LT nasal pillows); International Patent Applications WO 2005 / 063328 and WO 2006 / 130903 (which describe the MIRAGE LIBERTY TMOther aspects of full-face masks); International patent application WO 2009 / 052560 (which describes the SWIFT TM Other aspects of the FX pillows).

[0054] 2.2.3.1.2 Positioning and stabilization

[0055] The seal-forming structure of the patient interface for positive air pressure therapy is subjected to the corresponding force of the air pressure that will break the seal. Therefore, various techniques have been used to position the seal-forming structure and maintain it in a sealing relationship with the appropriate part of the face.

[0056] One technique is to use an adhesive. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

[0057] Another technique is to use one or more straps and / or stabilizing harnesses.Many of these harnesses suffer from one or more of poor fit, bulk, discomfort, and awkward use.

[0058] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0059] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the above-mentioned various therapies, for example, by operating the device to generate an air flow for delivery to an airway interface. The air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0060] Air pressure generators are known in a range of applications, for example, 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 reliability, size and weight requirements for medical devices. Furthermore, even devices designed for medical use may have disadvantages with respect to one or more of the following: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost and reliability.

[0061] An example of a special requirement for certain RPT devices is noise.

[0062] Table of noise output levels of existing RPT devices (a sample only, measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744).

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

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

[0065] ResMed Elisée TM 150 ventilator and ResMed VS III TM Respirators can provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of a variety of conditions. These ventilators provide volume and pressure ventilation modes with single-limb or double-limb circuits. RPT devices typically include a pressure generator, such as a blower driven by an electric motor or a compressed gas reservoir, and are configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface such as described above via an air circuit.

[0066] The designer of the device may be presented with an infinite number of choices that can be made. Design criteria often conflict, which means that some design choices are far from conventional or unavoidable. In addition, some aspects of comfort and efficacy may be highly sensitive to small and subtle changes in one or more parameters.

[0067] 2.2.3.3 Humidifier

[0068] Delivering an air stream without humidification may result in airway drying. Using a humidifier with an RPT device and a patient interface to produce humidified gas minimizes drying of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, warm air, which is often applied to the facial area in and around the patient interface, is more comfortable than cold air.

[0069] A range of artificial humidification devices and systems are known, however they may not meet the specific requirements of a medical humidifier.

[0070] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to ambient air when needed, usually where the patient may be asleep or resting (e.g., in a hospital). Medical humidifiers for bedside placement can be very small. A medical humidifier can be configured to only humidify and / or heat the air stream delivered to the patient, without humidifying and / or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers), for example, can also humidify the air that the patient breathes, but these systems also humidify and / or heat the entire room, which may cause discomfort to the occupants. In addition, medical humidifiers can have stricter safety constraints than industrial humidifiers.

[0071] Although many medical humidifiers are known, they may have one or more disadvantages. Some medical humidifiers may provide inadequate humidification, and some may be difficult or inconvenient to use by patients.

[0072] 2.2.3.4 Data Management

[0073] There may be many clinical reasons to obtain data to determine whether a patient being treated with a prescribed respiratory therapy is "compliant," e.g., that the patient has used their RPT device in accordance with one or more "compliance rules." One example of a compliance rule for CPAP therapy is a requirement that the patient use the RPT device for at least four hours per night for at least 21 of 30 consecutive days in order for the patient to be considered compliant. To determine the patient's compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing the use of the RPT device for the patient's treatment, calculate the usage over a predetermined time period and compare to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may inform the patient of the third part of compliance.

[0074] There are other aspects of patient treatment that may benefit from the communication of treatment data to third parties or external systems.

[0075] Existing methods of communicating and managing such data can be one or more of the following: expensive, time consuming, and error prone.

[0076] 2.2.3.5 Mandibular reduction

[0077] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from a dentist or other supplier that holds the mandible (lower jaw) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes after sleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom made or produced in a standard form and include a bite impression portion designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, exerts tension on the pharyngeal walls to reduce collapse of the airway and reduce vibrations of the palate.

[0078] In some examples, the mandibular advancement device may include an upper splint intended to engage or cooperate with teeth on the upper jaw or maxilla and a lower splint intended to engage or cooperate with teeth on the upper jaw or mandible. The upper splint and the lower splint are laterally connected together by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper splint and the lower splint.

[0079] In this design, the length of the connecting rod is selected so that when the MRD is placed in the patient's mouth, the mandible remains in an anteriorly displaced position. The length of the connecting rod can be adjusted to change the degree of protrusion of the mandible. The dentist can determine the degree of protrusion of the mandible, which will determine the length of the connecting rod.

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

[0081] 2.2.3.6 Ventilation technology

[0082] Some forms of therapeutic systems may include a vent to allow flushing of exhaled carbon dioxide. The vent may allow gas to flow from an interior space (eg, a plenum) of the patient interface to a space outside the patient interface, eg, to the environment.

[0083] The vent may include an orifice through which gas may flow when the mask is used. Many such vents are noisy. Others may become blocked when in use, thereby providing insufficient flushing. Some vents may, for example, disrupt the sleep of the patient's 1000 bed partner 1100 by making noise or by focusing airflow.

[0084] ResMed Ltd. has developed many improved mask ventilation technologies. See International Patent Application Publication No. WO 1998 / 034665; International Patent Application Publication No. WO 2000 / 078381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. US2009 / 0044808.

[0085] Noise table of existing masks (ISO 17510-2:2007, pressure of 10cmH2O at 1m)

[0086]

[0087]

[0088] (*One sample only, measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744)

[0089] The sound pressure values ​​for various objects are listed below

[0090]

[0091] 2.2.4 Screening, diagnosis and surveillance systems

[0092] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary disorders, and usually involves clinical experts to apply the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep apnea involves observing the patient in the clinic for two nights, one night for pure diagnosis and the other night for titration of treatment parameters by a clinician. Therefore, PSG is expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep apnea.

[0093] Screening and diagnosis generally describe the identification of a condition based on its signs and symptoms. Screening typically gives a true / false result indicating whether the patient's SDB is severe enough to warrant further investigation, while diagnosis can yield clinically actionable information. Screening and diagnosis tend to be one-time procedures, while monitoring of condition progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while some can also be used for monitoring.

[0094] Clinical experts can adequately screen, diagnose or monitor patients based on visual observation of PSG signals. However, there are situations where clinical experts may not be available or where clinical experts may not be affordable. Different clinical experts may have different opinions on a patient's condition. Furthermore, a given clinical expert may apply different criteria at different times. 3. Summary of the invention

[0095] The present technology is intended to provide a medical device for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders with improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0096] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0097] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0098] One aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0099] Another aspect of the present technology relates to a patient interface, which may include: a plenum chamber; a seal-forming structure; a positioning and stabilizing structure. The patient interface may further include a vent structure. The patient may be further configured so that the patient's mouth is uncovered, or if the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface may be further configured to allow the patient to breathe from the ambient environment in the absence of a flow of pressurized air through the plenum inlet port.

[0100] One aspect of the present technology relates to a patient interface, which may include an inflatable chamber that can be pressurized to a therapeutic pressure, a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding the patient's airway entrance, a positioning and stabilizing structure that provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, and a ventilation structure that allows gas exhaled by the patient to continuously flow from the interior of the inflatable chamber to the surrounding environment, wherein the patient interface is configured to leave the patient's mouth uncovered during treatment, wherein the seal-forming structure includes two lateral support regions and an intermediate region located between the lateral support regions, each lateral support region is located at the outermost side of the seal-forming structure, a hole passes through the intermediate region, and wherein the intermediate lateral support region is thicker than the intermediate region.

[0101] In an example of any aspect of any of the preceding paragraphs, (a) the seal-forming structure may include two intermediate lateral regions, each of which is laterally outward from and adjacent to the intermediate region and laterally inward from and adjacent to the lateral support regions, the intermediate lateral regions being thicker than the intermediate region and thinner than the lateral support regions, (b) the seal-forming structure may include two corner regions, the two corner regions being configured to engage the patient's face at the posterior upper side panel region, the corner regions being located where the intermediate region, the intermediate lateral regions, and the lateral support regions converge, (c) the aperture may be bridged into two nostril openings, the bridge being at the nasal opening may be surrounded by the middle region and the bridging portion, (f) the seal-forming structure may be formed of a flexible material, (g) the flexible material may be silicone, (h) the inflatable chamber may include an inner surface and an outer surface, and the inner surface may be configured to be at a therapeutic pressure during use, and the outer surface of the shell may be configured to be at an ambient pressure during use, (h) the inflatable chamber may be configured to be rigid when subjected to an internal pressure less than about 30 cmH2O above ambient pressure, (i) the inflatable chamber may be formed of a hard plastic material, and (j) the outer surface of the shell may be configured to be rigid when subjected to an internal pressure greater than about 30 cmH2O above ambient pressure. The inflatable chamber may be rigid when the ambient pressure is less than the internal pressure of about 30 cmH2O and may be formed of a transparent material, (k) the vent structure may include a plurality of vent holes formed in the inflatable chamber, (l) the intermediate region may extend to a front side of the seal-forming structure that does not contact the patient during use, (m) the intermediate region may extend to a front side of the seal-forming structure on an upper portion of the seal-forming structure, (n) the intermediate region may extend to a front side of the seal-forming structure on a lower portion of the seal-forming structure, (o) the intermediate lateral region may extend to a front side of the seal-forming structure that does not contact the patient during use, and (p) the intermediate lateral regions may extend to the front side of the seal-forming structure that does not contact the patient during use. The seal-forming structure may include a plurality of intermediate lateral regions extending from an upper portion of the seal-forming structure to a front side of the seal-forming structure, (q) the intermediate lateral regions may extend from a lower portion of the seal-forming structure to a front side of the seal-forming structure, (r) the bridge portion may be bent toward the inflation chamber to avoid contact with the patient's vagina during use, (s) the intermediate region may be positioned between the intermediate lateral regions so that the intermediate lateral regions are separated from each other, (t) the intermediate region and the intermediate lateral region may be positioned between the lateral support regions so that the lateral support regions are separated from each other, and / or (u) the shape and size of the seal-forming structure may be designed to not engage with a patient's nose that is above a nasal protrusion.

[0102] Another aspect of the present technology relates to a patient interface, which includes: an inflatable chamber that can be pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the inflatable chamber including an inlet port of the inflatable chamber, the size and structure of the inlet port of the inflatable chamber being designed to receive an air flow at the therapeutic pressure for breathing by the patient; a seal-forming structure, which is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having holes therein so that the air flow at the therapeutic pressure is delivered to at least one entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle in use; a positioning and stabilizing structure, which provides a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a strap, the strap being constructed and arranged so that when in use The invention relates to a device for positioning and stabilizing a patient's head, wherein at least a portion of the device covers an area of ​​the patient's head that is above the supra-auricular base point of the patient's head; and a vent structure that allows gas exhaled by the patient to flow continuously from the interior of the inflatable chamber to the surrounding environment, and the size and shape of the vent structure are designed to maintain the therapeutic pressure in the inflatable chamber during use; wherein the patient interface is configured so that the patient's mouth remains uncovered during treatment, wherein the inflatable chamber further includes a pair of inflatable chamber connectors, each inflatable chamber connector is positioned on a corresponding lateral side of the inflatable chamber, wherein the positioning and stabilizing structure further includes a tube having a pair of ends, wherein the positioning and stabilizing structure further includes a clamp engaged to a clamp overmolding at each end, the clamp overmolding being engaged to the tube at a corresponding one of these ends, and wherein each end is removably connected to a corresponding inflatable chamber connector by engagement of the clamp with the corresponding inflatable chamber connector.

[0103] In an example of any aspect of any of the preceding paragraphs, (a) the tube may be constructed of a first silicone material, each clamp overmold may be constructed of a second silicone material different from the first silicone material, and each clamp may be constructed of a first plastic material that is relatively more rigid than the first silicone material and the second silicone material, (b) the first silicone material may not be able to bond to the first plastic material, (c) the first silicone material may not be able to chemically bond to the first plastic material, (d) the second silicone material may be able to chemically bond to the first silicone material and to the first plastic material, (e) the tube may be constructed of a single, homogeneous piece of the first silicone material, (f) each clamp overmold may be constructed of a single, homogeneous piece of the second silicone material, (g) each clamp may be constructed of a single, homogeneous piece of the first plastic material, (h) the plenum may be constructed from a second plastic material, (i) the second plastic material and the first plastic material may be the same, (j) the second plastic material and the first plastic material may be different, (k) each connector in the plenum may include a pair of slots so that the plenum connector can be deformed to a reduced cross-section, (l) each plenum connector may be configured to connect to one of the corresponding clamps with a snap fit, (m) each clamp and each clamp overmolding may be completely positioned inside the corresponding end of the tube, (n) when the end of the tube is connected to the corresponding plenum connector in these plenum connectors, these plenum connectors can be completely positioned inside the corresponding end of the tube, and / or (o) each plenum connector may include a chamfered edge and each clamp may include a notch, and the chamfered edge and the corresponding notch are configured for snap fit engagement.

[0104] Another aspect of one form of the present technology is a patient interface molded or otherwise configured to have a peripheral shape that is complementary to the peripheral shape of the intended wearer.

[0105] One aspect of one form of the present technology is a method of manufacturing.

[0106] One aspect of some forms of the present technology is a medical device that is easy to use, for example, by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using medical devices of this type.

[0107] One aspect of one form of the present technology is a portable RPT device that can be carried by an individual (e.g., around the individual's home).

[0108] One aspect of one form of the present technology is a patient interface that can be cleaned at the patient's home, e.g., in soapy water, without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier canister that can be cleaned at the patient's home, e.g., in soapy water, without the need for specialized cleaning equipment.

[0109] The described methods, systems, devices, and apparatus may be implemented to improve the functionality of a processor, such as a processor of a dedicated computer, a respiratory monitor, and / or a respiratory therapy device. In addition, the described methods, systems, devices, and apparatus may provide improvements in the art of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0110] Of course, a part of these aspects may form a sub-aspect of the present technology. Each aspect and / or each of the aspects may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

[0111] Other features of the present technology will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims. 4. Description of the drawings

[0112] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals refer to like elements, including:

[0113] 4.1 Treatment system

[0114] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows receiving a supply of air at a positive pressure from a RPT device 4000. 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 partner 1100 is also shown. The patient sleeps in a supine sleeping position.

[0115] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the manner of a nasal mask receiving a supply of air at a positive pressure from a RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0116] Figure 1C A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask receiving a supply of air at a positive pressure from a RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying sleeping position.

[0117] 4.2 Respiratory system and facial anatomy

[0118] Figure 2A A schematic diagram of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm is shown.

[0119] Figure 2B 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 is shown.

[0120] Figure 2C is a front view of the face with several surface anatomical features labeled, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, nasal wing, nasolabial fold, and corner of mouth. The directions of superior, inferior, radially inward, and radially outward are also labeled.

[0121] Figure 2D It is a side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge point, nasal prominence point, nasal septum subseptum point, upper lip, lower lip, supramental point, nasal ridge, nasal wing apex, supra-auricular base point, and subauricular base point. The superior-inferior and anterior-posterior directions are also labeled.

[0122] Figure 2E This is another lateral view of the head. The approximate location of the Frankfort horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0123] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermillion, nostrils, subseptal point, columella, nasal process point, long axis of the nostrils, and midsagittal plane.

[0124] Figure 2G A side view of the nasal surface features is shown.

[0125] 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.

[0126] Fig.2I The medial anatomy of the nose is shown approximately a few millimeters from the mid-sagittal plane, showing, among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0127] Figure 2J A frontal view of the skull is shown, including the frontal, nasal, and zygomatic bones. The nasal turbinates are also labeled, as are the maxilla and mandible.

[0128] Figure 2K A side view of the skull is shown with the outline of the head surface and several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital. The mental protuberance is also labeled. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0129] Figure 2L An anterolateral view of the nose is shown.

[0130] 4.3 Patient Interface

[0131] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0132] Figure 3B A schematic diagram of a cross section through 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 is Figure 3C The curvature magnitude shown is relatively large in comparison.

[0133] Figure 3C A schematic diagram of a cross section through 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 is Figure 3B The curvature magnitude shown is relatively small in comparison.

[0134] Figure 3D A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0135] Figure 3E A schematic diagram of a cross section through 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 is Figure 3F The curvature magnitude shown is relatively small in comparison.

[0136] Figure 3F A schematic diagram of a cross section through 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 is Figure 3E The curvature magnitude shown is relatively large in comparison.

[0137] Figure 3G A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome area and the saddle area are indicated.

[0138] Figure 3HA cushion for a face mask is shown. The outer surface of the cushion 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 regions and one dome region are indicated.

[0139] Fig. 3I A surface having a structure with a one-dimensional hole on the surface is shown. The plane curves shown form the boundaries of the one-dimensional hole.

[0140] Figure 3J Shown through Fig. 3I The surface shown is in the cross section of the structure. Fig. 3I A two-dimensional hole is defined in the structure.

[0141] Figure 3K Shows Fig. 3I A perspective view of the structure of includes two-dimensional holes and one-dimensional holes. Also shown is the Fig. 3I The surface of the two-dimensional holes is defined in the structure.

[0142] Figure 3L A mask with an inflatable bladder as cushion is shown.

[0143] Figure 3M Shown through Figure 3L FIG. 1 is a cross-section of a mask of FIG. 1 and shows the inner surface of the airbag. The inner surface defines a two-dimensional hole in the mask.

[0144] Figure 3N Shown by Figure 3L Another cross section of a mask of FIG. The inner surface is also shown.

[0145] Fig.3O The left hand rule is shown.

[0146] Figure 3P The right hand rule is shown.

[0147] Figure 3Q The left ear is shown, including the left ear helix.

[0148] Figure 3R The right ear is shown, including the right ear helix.

[0149] Figure 3S A right-hand helix is ​​shown.

[0150] Figure 3T Views of a mask are shown including symbols for the twisting of the spatial curve defined by the edge of the sealing membrane in different regions of the mask.

[0151] Figure 3U A view of the plenum chamber 3200 is shown showing the sagittal plane and the medial contact plane.

[0152] Figure 3V Shows Figure 3U A view of the rear of the plenum chamber. The view is oriented perpendicular to the median contact plane. Figure 3V The sagittal plane in the middle bisects the air chamber into left and right sides.

[0153] Figure 3W Shown through Figure 3V The cross section of the gas-filled chamber is Figure 3V 32. The middle contact plane is perpendicular to the sagittal plane. The orientation of the middle contact plane corresponds to the orientation of the chord 3210, which lies on the sagittal plane and contacts the liner of the plenum at just two points on the sagittal plane, the upper point 3220 and the lower point 3230. Depending on the geometry of the liner in this area, the middle contact plane can be a tangent at the upper point and the lower point.

[0154] Figure 3X Shows Figure 3U The inflatable chamber 3200 is in the position of use on the face. When the inflatable chamber is in the use position, the sagittal plane of the inflatable chamber 3200 is roughly coincident with the central sagittal plane of the face. When the inflatable chamber is in the use position, the median contact plane generally corresponds to the 'plane of the face'. Figure 3X In FIG. 3 , the inflation chamber 3200 is the inflation chamber of the nasal mask, and the upper point 3220 is approximately located on the root of the nose, while the lower point 3230 is located on the upper lip.

[0155] 4.4RPT device

[0156] Figure 4A One form of RPT device according to the present technology is shown.

[0157] Figure 4B is a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology. Upstream and downstream directions are indicated with reference to a blower and a patient interface. 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 particular moment. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0158] 4.5 Humidifier

[0159] Figure 5A is an isometric view of a humidifier according to one form of the present technology.

[0160] Figure 5B An isometric view of a humidifier in accordance with one form of the present technology is shown showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0161] Figure 5C A schematic diagram of a humidifier according to one form of the present technology is shown.

[0162] 4.6 Respiratory waveform

[0163] Figure 6 A model typical breathing waveform of a person during sleep is shown.

[0164] 4.7 Patient Interface According to the Present Technology

[0165] Figure 7 is a front side view of an example of the present technology worn by a patient, as viewed from an upper position of a patient interface.

[0166] Figure 8 is a front view of a patient interface according to an example of the present technology worn by a patient.

[0167] Fig. 9 is a top view of a patient interface according to an example of the present technology worn by a patient.

[0168] Fig.10 is a side view of a patient interface according to an example of the present technology worn by a patient.

[0169] Fig.11 is a front side view of an example of the present technology worn by a patient, as viewed from an upper position of a patient interface.

[0170] Fig.12 is a front view of a patient interface according to an example of the present technology.

[0171] Fig.13 is a front side view viewed from an upper position of a patient interface according to an example of the present technology.

[0172] Fig.14 is a rear view of a patient interface according to an example of the present technology.

[0173] Fig.15 is a top view of a patient interface according to an example of the present technology.

[0174] Fig.16 is a front side view from an upper position of a seal-forming structure for a patient interface according to an example of the present technology.

[0175] Fig.17 is a top view of a seal-forming structure for a patient interface according to an example of the present technology.

[0176] Fig.18 is a bottom view of a seal-forming structure for a patient interface according to an example of the present technology.

[0177] Fig.19is a rear view of a seal-forming structure for a patient interface according to an example of the present technology.

[0178] Fig. 20 is a front view of a seal-forming structure for a patient interface according to an example of the present technology.

[0179] Fig.21 is a side view of a seal-forming structure for a patient interface according to an example of the present technology.

[0180] Fig. 22 is a posterolateral view from a superior position of a seal-forming structure for a patient interface according to an example of the present technology.

[0181] Fig.23 is a front side view of an upper position of a seal-forming structure and an inflatable chamber for a patient interface according to an example of the present technology.

[0182] Fig.24 is a front view of a seal-forming structure and an inflatable chamber for a patient interface according to an example of the present technology.

[0183] Fig.25 is a rear view of a seal-forming structure and an inflatable chamber for a patient interface according to an example of the present technology.

[0184] Fig.26 is a top view of a seal-forming structure and an inflatable chamber for a patient interface according to an example of the present technology.

[0185] Fig. 27 is a bottom view of a seal-forming structure and an inflatable chamber for a patient interface according to an example of the present technology.

[0186] Fig.28 is a rear view of an upper position of a seal-forming structure and an inflatable chamber for a patient interface according to an example of the present technology.

[0187] Fig.29 is a front view of a seal-forming structure for a patient interface according to an example of the present technology.

[0188] Fig.30 is a top view of a seal-forming structure for a patient interface according to an example of the present technology.

[0189] Fig.31 is a bottom view of a seal-forming structure for a patient interface according to an example of the present technology.

[0190] Fig.32 is a rear view of a seal-forming structure for a patient interface according to an example of the present technology.

[0191] Fig.33is a front view of a seal-forming structure for a patient interface according to an example of the present technology.

[0192] Fig.34 is a side view of a seal-forming structure for a patient interface according to an example of the present technology.

[0193] Fig.35 is a front side view of an upper position of a seal-forming structure and an inflatable chamber for a patient interface according to an example of the present technology.

[0194] Fig.36 is a rear view of an upper position of a seal-forming structure and an inflatable chamber for a patient interface according to an example of the present technology.

[0195] Fig.37 is a front view of a seal-forming structure for a patient interface according to an example of the present technology.

[0196] Fig.38 is a rear view of a seal-forming structure for a patient interface according to an example of the present technology.

[0197] Fig.39 is a side view of a seal-forming structure for a patient interface according to an example of the present technology.

[0198] Fig.40 is a bottom view of a seal-forming structure for a patient interface according to an example of the present technology.

[0199] Fig.41 is a front view of a seal-forming structure for a patient interface according to an example of the present technology.

[0200] Fig.42 is a top view of a seal-forming structure for a patient interface according to an example of the present technology.

[0201] Fig.43 is a front side view of an upper position of a seal-forming structure and an inflatable chamber for a patient interface according to an example of the present technology.

[0202] Fig.44 is a rear view of an upper position of a seal-forming structure and an inflatable chamber for a patient interface according to an example of the present technology.

[0203] Fig.45 is a front view of a seal-forming structure for a patient interface according to an example of the present technology.

[0204] Fig.46 is a rear view of a seal-forming structure for a patient interface according to an example of the present technology.

[0205] Fig.47is a side view of a seal-forming structure for a patient interface according to an example of the present technology.

[0206] Fig.48 is a bottom view of a seal-forming structure for a patient interface according to an example of the present technology.

[0207] Fig.49 is a front view of a seal-forming structure for a patient interface according to an example of the present technology.

[0208] Fig.50 is a top view of a seal-forming structure for a patient interface according to an example of the present technology.

[0209] Fig.51 is a front side view of an upper position of a seal-forming structure and an inflatable chamber for a patient interface according to an example of the present technology.

[0210] Fig.52 is a rear view of an upper position of a seal-forming structure and an inflatable chamber for a patient interface according to an example of the present technology.

[0211] Fig.53 is a front reference view of a cross section taken through line 54 - 54 of a seal-forming structure and plenum chamber for a patient interface according to an example of the present technology.

[0212] Fig.54 is through Fig.53 Detailed cross-sectional view of a plenum chamber according to an example of the present technology, taken along line 54-54.

[0213] Fig.55 is an exploded front view of a seal-forming structure and an inflation chamber disconnected from a conduit for a patient interface according to an example of the present technology.

[0214] Fig.56 5 is a front reference view of a cross section taken along lines 57 - 57 and 60 - 60 through a seal-forming structure and a plenum chamber connected to a conduit for a patient interface in accordance with an example of the present technology.

[0215] Fig.57 is through Fig.56 A detailed cross-sectional view of the plenum connector and conduit connected together according to an example of the present technology, taken along line 57-57.

[0216] Fig.58 is a perspective view of a clamp and clamp overmold for a catheter according to an example of the present technology.

[0217] Fig.59 Is from Fig.57 Cross-sectional view of a catheter.

[0218] Fig.60 is along Fig.56 A cross-sectional view taken along line 60-60 through the catheter and into the plenum chamber.

[0219] Fig.61 is a rear view of an inflatable chamber and an inflatable chamber connector according to an example of the present technology.

[0220] Fig.62 is a front view of a seal-forming structure and plenum chamber for a patient interface without a vent insert in the vent insert opening in accordance with an example of the present technology.

[0221] Fig.63 is a front view of a seal-forming structure and plenum chamber for a patient interface with a vent insert in a vent insert opening in accordance with an example of the present technology.

[0222] Fig.64 is a cross-sectional view through a plenum chamber of a patient interface according to an example of the present technology.

[0223] Fig.65 is a cross-sectional view through a plenum chamber of a patient interface according to an example of the present technology.

[0224] Fig.66 is a top view of a patient interface according to an example of the present technology.

[0225] Fig.67 It shows that according to Fig.16 A cross-sectional view of the interior of a seal-forming structure of an example of the present technology is depicted in FIG.

[0226] Fig.68 It shows that according to Fig.29 A cross-sectional view of the interior of a seal-forming structure of an example of the present technology is depicted in FIG.

[0227] Fig.69 It shows that according to Fig.37 A cross-sectional view of the interior of a seal-forming structure of an example of the present technology is depicted in FIG.

[0228] Fig.70 It shows that according to Fig.45 A cross-sectional view of the interior of a seal-forming structure of an example of the present technology is depicted in FIG. 5. Specific implementation methods

[0229] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, which may be varied. It should also be understood that the terminology used in the present disclosure is only for the purpose of describing the specific examples described herein and is not intended to be limiting.

[0230] 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 one example may be combined with one or more features of another example or other examples. In addition, in any one of the examples, any single feature or combination of features may constitute another example.

[0231] 5.1 Treatment

[0232] In one form, the present technology includes a method for treating a breathing disorder, the method comprising the step of applying positive pressure to an airway entrance of a patient 1000 .

[0233] In certain examples of the present technology, a supply of air under positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0234] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.

[0235] 5.2 Treatment system

[0236] In one form, the present technology includes an apparatus or device for treating a respiratory disorder. The apparatus or device may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 leading to a patient interface 3000 .

[0237] 5.3 Patient Interface

[0238] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to a form of 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, one physical component may provide one or more functional aspects. When in use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway so as to facilitate the supply of air under positive pressure to the airway.

[0239] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0240] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide air at a positive pressure of at least 6 cmH2O relative to ambient.

[0241] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide air at a positive pressure of at least 10 cmH2O relative to ambient.

[0242] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide air at a positive pressure of at least 20 cmH20 relative to ambient.

[0243] 5.3.1 Sealing structure

[0244] In one form of the present 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 sealing is likely to occur. The area where sealing actually occurs - the actual sealing surface - can vary from day to day and from patient to patient within a given course of treatment, depending on a range of factors including, for example, where the patient interface is placed on the face, the tension in the positioning and stabilizing structures, and the shape of the patient's face.

[0245] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0246] In some forms of the present technology, the seal-forming structure 3100 is formed from a biocompatible material, such as silicone rubber.

[0247] A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible and resilient material such as silicone.

[0248] In some forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure being configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 that is suitable for large-sized heads but not for small-sized heads, and another form that is suitable for small-sized heads but not for large-sized heads.

[0249] 5.3.1.1 Sealing mechanism

[0250] In one form, the seal forming structure includes a sealing flange that utilizes a pressure assisted sealing mechanism. In use, the sealing flange can easily respond to the system positive pressure acting on the interior of the inflatable chamber 3200 on its bottom side, so that it forms a tight sealing engagement with the face. The pressure assist mechanism can act together with the elastic tension in the positioning and stabilizing structure.

[0251] In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm, for example, about 0.25 mm to about 0.45 mm, which extends around the periphery of the plenum 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the plenum 3200 and extends around at least a portion of the path of the perimeter. The support flange is or includes a spring-like element and acts to support the sealing flange to prevent it from bending during use.

[0252] In one form, the seal forming structure may include a compression seal or a gasket seal. In use, the compression seal or the gasket seal is constructed and arranged to be in a compressed state, for example, as a result of elastic tension in the positioning and stabilizing structure.

[0253] In one form, the seal-forming structure comprises a tensioning portion. In use, the tensioning portion is held in tension, for example, by an adjacent region of the sealing flange.

[0254] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0255] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal portion, a gasket seal portion, a tensioning portion, and a portion having a tacky or adhesive surface.

[0256] 5.3.1.2 Nose bridge or nasal ridge area

[0257] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over a nasal bridge region or nasal ridge region of a patient's face.

[0258] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal over a nasal bridge region or a nasal ridge region of the patient's face.

[0259] 5.3.1.3 Upper lip area

[0260] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the upper lip region (ie, upper lip) of the patient's face when in use.

[0261] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal on an upper lip region of a patient's face in use.

[0262] 5.3.1.4 Chin area

[0263] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal over the chin region of the patient's face when in use.

[0264] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal when used on a chin region of a patient's face.

[0265] 5.3.1.5 Forehead area

[0266] In one form, the seal-forming 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.

[0267] 5.3.1.6 Nasal pillows

[0268] In one form, the seal-forming structure of the non-invasive patient interface 3000 comprises a pair of nasal puffs or pillows, each of which is constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0269] A nasal pillow according to one aspect of the present technology includes: a frustoconical body, at least a portion of which forms a seal on the bottom surface of the patient's nose; a stem; and a flexible region on the bottom surface of the frustoconical body and connecting the frustoconical body to the stem. In addition, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the bottom of the stem. The flexible region can work together to facilitate a universal engagement structure that can adapt to relative movement of both displacement and angle between the frustoconical body and the structure to which the nasal pillows are connected. For example, the position of the frustoconical body can be moved axially toward the structure to which the stem is connected.

[0270] 5.3.1.7 Nasal support

[0271] Figure 16-28 and Fig.67 A seal-forming structure 3100 according to a first example of the present technology is shown. Figure 22-28 A seal-forming structure 3100 is shown having a plenum chamber 3200, which will be described in more detail below. Figure 29-36 and Fig.68 A seal-forming structure 3100 according to a second example of the present technology is shown. Fig.35 and Fig.36 A seal-forming structure 3100 is shown having a plenum chamber 3200, which will be described in more detail below. Figure 37-44 and Fig.69 A seal-forming structure 3100 according to a third example of the present technology is shown. Fig.43 and Fig.44 A seal-forming structure 3100 is shown having a plenum chamber 3200, which will be described in more detail below. Figure 45-52 and Fig.70A seal-forming structure 3100 according to a fourth example of the present technology is shown. Fig.51 and Fig.52 A seal-forming structure 3100 having an inflatable chamber 3200 is shown, which will be described in more detail below. As can be seen in these views, the sizes and shapes of the different examples are different, and therefore, each variation is intended to provide the best fit for patients with noses and faces of different shapes and sizes. Figure 16-21 , Figure 29-34 , Figure 37-42 and Figure 45-50 Dashed lines are included to demarcate regions of varying thickness, and it should be understood that these are merely nominal boundaries and not actual structures.

[0272] The four instances of the seal-forming structure 3100 described in the previous paragraph can be considered as nasal support cushions and are intended to provide a pressurized gas flow to the patient's nostrils by sealing at least the underside of the patient's nose. The exemplary seal-forming structure 3100 will engage the patient's face below the bridge of the nose, and depending on the size and shape of the patient's nose, some instances may engage the patient's nose below the nasal prominence. In other words, for example, the seal-forming structure 3100 may be constructed to not engage the patient's nose above the nasal prominence. The exemplary seal-forming structure 3100 will also engage the patient's face at least above the upper lip. Therefore, the exemplary seal-forming structure 3100 can be sealed against the patient's upper lip during use. In addition, the patient's mouth can remain uncovered by the seal-forming structure 3100 of the depicted instance, so that the patient can breathe freely, i.e., breathe directly into the atmosphere without interference from the seal-forming structure 3100.

[0273] Examples of nasal support cushions, such as the exemplary seal-forming structures disclosed herein, can include an upper saddle or concave area having a positive curvature across the cushion. Moreover, a nasal support cushion can be understood to have a single targeted seal-forming area or surface, while a pillow cushion can have two targeted seal-forming areas (one for each nostril). The support cushion can also have a posterior wall that contacts the upper portion of the patient's lips and an upper center surface that contacts the underside of the patient's nose. These two surfaces of the patient's face can form a nasolabial angle therebetween (see Figure 2E ). The support cushion can be shaped to have a nasolabial angle in the range of 90 degrees to 120 degrees.

[0274] Furthermore, the shape and size of the exemplary seal-forming structure 3100 may also be designed such that no portion of the seal-forming structure 3100 enters the patient's nostrils during use.

[0275] Although different in various aspects further described below, the exemplary seal-forming structure 3100 can each include at least two regions of different thicknesses: a lateral support region 3108 and a middle region 3114. In a further example, there can also be another third region of different thicknesses (in addition to the lateral support region 3108 and the middle region 3114), and a middle lateral region 3110. In a further example, there can also be another fourth region of different thicknesses (in addition to the lateral support region 3108, the middle lateral region 3110, and the middle region 3114), and a front region 3109. As shown in the example, different thicknesses can be generated by extending regions of different thicknesses to different distances inside the seal-forming structure 3100, so that the outer surface of the seal-forming structure 3100 remains smooth. The outer surface may not be uneven at the transition region between regions of different thicknesses. Therefore, the exterior of the exemplary seal-forming structure 3100 is continuous and smooth.

[0276] 5.3.1.7.1 Horizontal support area

[0277] A lateral support region 3108 may be provided at each outermost side of each seal-forming structure 3100. An exemplary seal-forming structure 3100 may include two lateral support regions 3108, each lateral support region 3108 being spaced away from a plane bisecting the seal-forming structure 3100, which plane would be parallel to the patient's sagittal plane in use. The lateral support regions 3108 may be the thickest portion of the seal-forming structure 3100 to provide resistance to lateral displacement, such as that caused by a patient sleeping on the side of their head, causing the pillow to push against the seal-forming structure laterally and provide a secure engagement against the patient's ALA. The lateral support regions 3108 may have a thickness of about 0.9 mm to about 1.5 mm, or about 1.3 mm to about 1.4 mm, or about 1.3 mm, or about 1 mm to about 1.5 mm. Because the lateral support regions 3108 are the thickest regions of the seal-forming structure 3100 in the depicted example and because the exemplary seal-forming structure 3100 is constructed or molded from a single homogeneous piece of material (e.g., liquid silicone rubber), the lateral support regions 3108 can also provide maximum resistance to deformation.

[0278] In addition, the lateral support region 3108 can provide sufficient rigidity to ensure adequate sealing in the posterior upper side sheet region of the patient's face (i.e., the region where the nose wing terminates at the upper lip closest to the nasolabial groove), which is an area of ​​particularly complex geometry. The posterior upper side sheet region of the patient's face presents a particularly complex geometry because at least three facial surfaces - the nose wing, the upper lip, and the cheek converge in this region. Therefore, sufficient rigidity in the lateral support region 3108 can ensure that the seal-forming structure 3100 can be pushed into the posterior upper side sheet region by tension from the positioning and stabilizing structure 3300 without collapsing. For example, insufficient rigidity at the portion of the seal-forming structure 3100 that engages this region of the patient's face can result in wrinkles due to too thin a material, which forms a leak path within the seal region, allowing pressurized gas to leak into the atmosphere along a path within the wrinkle formed between the exterior of the seal-forming structure 3100 and the patient's facial skin.

[0279] These lateral support areas 3108 can be located on the patient's face in the area below the patient's ala nasi and in the area below and laterally outside the patient's nose, for example, between the nasolabial grooves and the upper lip area below the ala nasi.

[0280] A double wall design can be used to prevent the sealing surface from collapsing, as described in International Application Publication No. WO 2017 / 185140A1. Figure 7 A-7M, which is incorporated herein by reference in its entirety. Examples of the present technology include a seal-forming structure 3100 having a single wall, and preventing collapse of the sealing joint by, for example, increased thickness of the seal-forming structure 3100 at the lateral support area 3108.

[0281] In addition, the lateral support regions 3108 can provide resistance to lateral displacement of the seal-forming structure 3100 as the patient's head moves. The shape and dimensions of the seal-forming structure 3100 can be determined so that when an appropriately sized instance is fitted to a given patient, the lateral support portions 3108 extend around and contact the patient's ala nostrils. Because the facial structures of the lower ala skin are less rigid (e.g., Figure 2H ) and so the ala nasi may be more easily deformed, but sufficient rigidity provided by the lateral support region 3108 can ensure that the seal-forming structure 3100 maintains sealing engagement with the ala nasi when the patient's head moves (e.g., when the head is tilted so that one side of the patient interface 3000 is forced against a pillow).

[0282] Depending on the shape and size of the patient's facial structure (e.g., nose, nose wings, upper lips, and cheeks), the lateral support areas 3108 may contact the patient's nose wings, upper lips, and / or cheeks during use. In some examples, these lateral support areas 3108 may be shaped and sized so that they avoid the patient's pronasal prominence and / or subnasal prominence.

[0283] Figures 67-70 An example of a seal-forming structure 3100 is depicted, shown with an exemplary nostril profile 1001 and a nasal base profile 1002. While these examples do not show the nasal wing area of ​​the nasal base profile 1002 extending wide enough to contact the lateral support area 3108, it should be understood that in use, the lateral support area 3108 can extend above to surround the nasal wing. Thus, the lower portion of the patient's nasal wing may not contact the lateral support portion 3108, but once the nose is received into the seal-forming structure 3100, the lateral portion of the patient's nasal wing may contact the lateral support portion 3108. The fit depends on the size and shape of a given patient's nose, and in some examples, the patient's nose may be wide enough so that the lower portion of the nasal wing does contact the lateral support portion 3108 in addition to the side of the nasal wing. In a further example, the patient's nose may be so narrow that no portion of the nasal wing contacts the lateral support area 3108.

[0284] from Figures 67-70 As can be seen in FIG, there can be a fairly abrupt transition (e.g., an abrupt taper or almost a step) between areas of different thickness. Although facial geometry can vary widely between patients, the abrupt transition can be located almost directly below the nose wing on the upper portion of the lip.

[0285] The edges of the lateral support regions 3108 can track upward, outward, and then inward to follow the curvature of the patient's nose in an upward direction starting from below the ala of the patient's nose (e.g., follow the curvature along either side of the nose "up" on the patient's face). Thus, the lateral support regions 3108 support the seal-forming structure 3100 on the patient's face below and on the lateral sides of the patient's nose while causing the intermediate region 3114 to conform and seal with the ala and underside of the patient's nose.

[0286] The lateral support regions 3108 may extend from the plenum 3200 all the way to the corners of the seal-forming structure 3100 to support the cushion and structurally rigidify it. In some examples, the lateral support regions 3108 may be thickest adjacent to where the seal-forming structure 3100 meets the plenum 3200 and then decrease in thickness away from the plenum 3200. However, the lateral support regions 3108 may not extend around the entire plenum 3200. For example, as described below, the intermediate region 3114 may extend at the central upper / front region of the seal-forming structure 3100 to the periphery of the plenum 3200.

[0287] While the increased thickness of the lateral support regions 3108 may be desirable for structural rigidity, the seal-forming structure 3100 may still retain a degree of flexibility such that the lateral portions of the seal-forming structure 3100 can be pushed or pulled inwardly laterally to accommodate noses of varying widths. For example, the non-patient-facing sides of the seal-forming structure 3100 (particularly the non-patient contacting regions on either side of the seal-forming structure 3100) may be thick enough to provide sufficient structural rigidity to the seal-forming structure 3100, but may still be thin enough such that when the seal-forming structure 3100 is worn by a patient with an elongated nose, the compressive force in the forward direction exerted by the patient's nose on the middle region 3114 can pull the outer sides of the seal-forming structure 3100 (i.e., the lateral support portions 3108) medially so that the seal-forming structure 3100 on either side of the patient's nose contacts the patient's nose (e.g., at the wings of the nose). If a patient with a wider nose wears the seal-forming structure 3100, the seal-forming structure 3100 can be flexible enough so that there is no excessive force in the medial direction on the lateral sides of the patient's nose, which may occur if the seal-forming structure 3100 is too rigid to tolerate the wider nose.

[0288] 5.3.1.7.2 Intermediate area

[0289] The middle region 3114 may be centrally located on the seal-forming structure 3100. In use, the middle region 3114 may be bisected by a plane parallel to the patient's sagittal plane. Since the middle region 3114 is centrally located, there may be only one such region.

[0290] In the depicted example, nostril openings 3102 may be formed through the intermediate region 3102. These nostril openings 3102 are positioned to generally align with the patient's corresponding nostrils to provide a flow of pressurized gas to the patient's nostrils for inhalation and to direct exhaled gas back into the seal-forming structure 3100 for exhaust to the atmosphere via the plenum vent 3400, as further described below. Figures 67-70Examples are shown of approximate alignment of the nostril contour 1001 with the corresponding nostril opening 3102. These examples illustrate that the nostril contour 1001 may not necessarily match the size and shape of the nostril opening 1002, as there is great variability in the size and shape of the nostrils of a patient.

[0291] As in Figures 67-70 As can be seen in the examples of the middle region 3114, the middle region 3114 can contact a major portion of the base or underside of the patient's nose. In many patients, this is a particularly sensitive area. Moreover, patients exhibit a great deal of variability in the geometry of the base or underside of the nose. Therefore, the middle region 3114 can be relatively thinner than other areas of the seal-forming structure 3100 to increase flexibility and conform to the contours of the patient's facial and nasal geometry. In the examples depicted, the middle region 3114 is the thinnest region. In these examples, the middle region 3114 can have a thickness of approximately 0.25 mm.

[0292] The depicted example shows the middle lateral region 3110 laterally outward from the middle region 3114, and the lateral support region 3108 is shown further laterally outward. Thus, in some examples and depending on the size and shape of the patient's nose, if the nose is wide enough, the nose wings may not contact the middle region 3114 at all. In patients with narrower noses, a portion of their nose wings may contact the middle region 3114.

[0293] The middle region 3114 may also extend around the front side of the seal-forming structure 3100 so that the patient's nasal prominence contacts the upper portion of the middle region 3114. The patient's upper lip and / or lower nose point may also contact the lower portion of the middle region 3114. The nasal prominence, upper lip, and lower nose point may also be particularly sensitive areas, so engaging these sensitive areas and reducing discomfort may be beneficial to increasing compliance of the middle region 3114. As can be seen in the views of these examples,

[0294] Depending on the shape and size of the patient's facial structure (e.g., nose, nose wings, upper lip and cheeks), the middle region 3114 can contact the patient's upper lip, lower nose point and / or nasal prominence point during use. In some examples, the middle region 3114 can be shaped and sized so that they avoid the patient's nasal prominence point and / or lower nose point.

[0295] Within the middle region 3114, there may be a nasal prominence area 3117 where the patient's nasal prominence may contact the seal-forming structure 3100. However, it should be understood that a shorter nose may not reach the nasal prominence area 3117, and a longer nose may extend beyond the nasal prominence area 3117 such that the nasal prominence does not contact the nasal prominence area 3117 in either case. Figure 16-28 and Fig.67 as well as Figure 29-36 and Fig.68 The nasal prominence area 3117 in the example of can extend to the front side of the seal-forming structure, i.e., away from the patient, so that a portion of the nasal prominence area 3117 does not contact the patient's face. This arrangement can also allow the engagement of the nasal prominence to pull the lateral sides of the seal-forming structure 3100 inward to engage the nose. Figure 37-44 and Fig.69 as well as Figure 45-52 and Fig.70 The nasal prominence region 3117 in the examples may not extend forward to have a portion that cannot be contacted by the patient's nose as these shapes are intended for wider noses that may already be able to adequately engage the lateral portions of the seal-forming structure 3100.

[0296] Within the middle region 3114, there can be an upper lip region 3116 where the upper lip of the patient can contact the seal-forming structure 3100. The patient's subnasal point can also contact the seal-forming structure 3100 at the upper lip region 3116. In some instances, the upper lip region 3116 can be adjacent to the patient's subnasal point but not in direct contact with the patient's subnasal point. Thus, within the boundaries of the seal formed against the patient's face, there can be a gap between the patient's face and the seal-forming structure 3100.

[0297] Additionally, because the middle region 3114 is relatively thin, the pressure of the air within the seal-forming structure 3100 may cause the seal-forming structure 3100 to expand during use. By causing the seal-forming structure 3100 to expand during use, the middle region 3114 is easily pushed against the contours of the patient's face and nose, for example, at the underside, at the nose wings, at the upper lip, at the subnasal point, and / or at the nasal prominence, to ensure an adequate seal.

[0298] While a relatively low material thickness may have benefits for the middle region 3114 as described above and below, making the middle region 3114 too thin may result in excessive wrinkling, which in turn may form a leak path for gas to escape through the sealing boundary to the atmosphere. Moreover, the middle region 3114 may benefit from being thick enough to maintain a stable seal that is not easily displaced by movement of the patient or contact with an object such as a pillow. Wrinkles may be of particular concern in the nasal prominence region 3117, particularly along the centerline of the seal-forming structure 3100 (i.e., along a plane that is parallel to the patient's sagittal plane during use). Therefore, in some instances, the middle region 3114 may be thickened in the nasal prominence region 3117 relative to other portions of the middle region 3114.

[0299] In the middle region 3114, there may also be a bridge 3104 between the nostril openings 3102. The bridge 3104 may be long enough to relax in an undeformed state so that when the patient's nose contacts the middle region 3114, the bridge 3104 may adapt to the deformation of the seal-forming structure 3100 without stretching. The bridge 3104 may be thicker than the middle region 3114 or may have the same thickness. In one example, the bridge has a thickness of about 0.35 mm. Another method to prevent tearing is to make the bridge 3104 wider. When the bridge 3104 is elongated by the engagement of the seal-forming structure 3100 with the patient's nose, configuring the bridge 3104 to have a relatively greater thickness than the adjacent middle region 3114 may help prevent tearing. The bridge 3104 may be S-shaped to allow straightening to allow the upper portion of the middle region 3114 to move away from the upper portion of the lower lip. The bridge 3104 may be arcuate, curved, and / or slightly folded in its undeformed state.

[0300] The bridge 3104 may be longer or have more material than is necessary to bridge the gap between the top and bottom of the middle region 3114. This extra material allows for stretching while the bridge 3104 stretches before it becomes tight. If there is no extra material, the bridge 3104 may become taut after a force is applied to the top of the middle region 3114, and the bridge 3104 will not tolerate any movement of the top of the middle region 3114 (and therefore may not achieve the effect of tolerating a longer nose). Since the bridge 3104 may not have to engage and seal to the columella to completely seal around the patient's nose, the nose may be adequately sealed even if the bridge 3104 remains loose.

[0301] The bridge 3104 can maintain the integrity of the seal-forming structure 3100 in the middle region 3114. If the bridge 3104 is not present and a single air opening is present instead due to the relatively thin wall thickness of the middle region 3114, there may be a risk that the nasal prominence region 3117 of the seal-forming structure 3100 will burst (i.e., pressure from the gas will blow the nose away from the sealing surface and prevent sealing engagement) if the seal-forming structure 3100 is modified (e.g., by pulling and resealing of the face) or receives intense dynamic loads when under pressure. The bridge 3104 can prevent bursting by tying the nasal prominence region 3117 to the upper lip region 3116.

[0302] Additionally, the bridge 3104 may prevent user setup errors by preventing the patient's nose from being inserted into what would otherwise be a single hole.

[0303] 5.3.1.7.3 Intermediate lateral area

[0304] The intermediate lateral regions 3110 may be provided laterally inwardly or in a medial direction relative to the lateral support region 3108. The intermediate lateral regions 3110 may be laterally outwardly relative to the intermediate region 3114. An exemplary seal-forming structure 3100 may include two intermediate lateral regions 3110, each spaced away from a plane bisecting the seal-forming structure 3100, which plane will be parallel to the sagittal plane of the patient in use. The intermediate lateral regions 3110 may be positioned such that each intermediate lateral region 3110 is adjacent to a corresponding lateral support region 3108 on one side and adjacent to a corresponding side of the intermediate region 3114 on the other side.

[0305] Depending on the shape and size of the patient's facial structure (e.g., nose, nose wing, upper lip and cheek), the middle lateral region 3110 may contact the patient's nose wing during use. In some examples, the shape and size of these middle lateral regions 3110 can be determined so that they avoid the patient's upper lip, cheek, nasal prominence and / or subnasal point. Figures 67-70 An example is shown where the nasal base contour 1002 contacts the front of the middle lateral region 3110 when it extends to the middle lateral region 3110 at its widest point, which is the lateral boundary of the base of the ala. In other examples, when the patient has a relatively narrow nose, the nasal base contour 1002 can remain within the boundaries of the middle region 3114 so that the middle lateral region 3110 and the outer lateral support region 3108 contact the outer portion of the ala but not the underside. In other examples where the patient's nose is relatively wide, the base of the ala can extend beyond the middle lateral region 3110 to the lateral support region 3108.

[0306] In some examples, the intermediate lateral regions 3110 can be thicker than the intermediate regions 3110 and thinner than the lateral support regions 3108. These intermediate lateral regions 3110 can have a thickness of about 0.5 mm to about 0.7 mm, or about 0.6 mm, or about 0.75 mm.

[0307] 5.3.1.7.4 Front area

[0308] Additional examples of the seal-forming structure 3100 may include a front region 3109. The front region 3109 may face in a direction away from the patient in use, and in some examples, the patient's face may not contact the front region 3109. In some examples, the front region 3109 may be thinner than the lateral support region 3108 and thicker than the middle region 3114. In some examples, the front region 3109 may have a thickness of about 0.5 mm to about 0.7 mm, or about 0.6 mm, or about 0.75 mm.

[0309] The front region 3109 may support the seal-forming structure 3100 by resisting compression of the seal-forming structure 3100 in a forward direction during use.

[0310] 5.3.1.7.5 Corner area

[0311] The exemplary seal-forming structure 3100 may also include two corner regions 3115 formed generally at the region where the middle region 3114, the lateral support region 3108, and the middle lateral region 3110 converge. The corner regions 3115 may be intermediate relative to the lateral support region 3108 or relative to the lateral support region 3108 and the middle lateral region 3110.

[0312] from Figures 67-70 1002 terminates (i.e., near the posterior upper side panel region). These corner regions 3115 can be shaped and sized to extend into and seal with the posterior upper side panel region of the patient's face. As described above, the relatively thick lateral support regions 3108 can effectively ensure that an adequate seal is maintained in areas with relatively complex facial geometry, such as the posterior upper side panel region. Therefore, by extending the corner regions 3115 medially, the lateral support regions 3108 or the lateral support regions 3108 and the middle lateral regions 3110 extend into the posterior upper side panel region to provide an effective seal in the complex and concave geometry of this region.

[0313] The alar of some patients may be significantly curved, and many patients may have very concave dimples or cavities where the alar meets the face (i.e., the posterior superior side panel region). These dimples may be created by the alar curving medially toward the sagittal plane between the widest portion of the nose (i.e., along a line drawn across the sagittal plane from alar vertex to alar vertex) and the junction of the alar with the face (i.e., the posterior superior side panel region). Providing thin material (i.e., the middle region 3114 portion of the corner region 3115) to engage these corners of the patient's facial geometry can enable the seal-forming structure 3100 to deform to match the curvature of the alar and at least partially, if not completely, fill in the cavities that may exist at the lower corners of the patient's nose. The seal-forming structure 3100 may be configured so that the edges of the lateral support regions 3108 may be located on the patient's face laterally outboard of the ala of the nose, but sufficiently close to the ala of the nose so that the areas of the cushion that contact the patient's face on either lower side of the nose are within the lateral support regions 3108 for support and stabilization to the seal-forming structure 3100. The middle region 3114 components of the corner regions 3115 may be deformed to such an extent that in use the ala of the patient's nose (at least the portion thereof proximal to the upper lip) may be located thereon to form a shelf so that in use the seal-forming structure 3100 conforms to the lower periphery of the patient's nose, particularly proximal to the upper lip.

[0314] 5.3.1.7.6 Wrinkle resistance

[0315] Positioning the middle region 3114 to the seal-forming structure 3100 to seal to the underside of the patient's nose, and positioning the middle-lateral region 3110 and / or the outer lateral support portion 3108 to surround some or all of the middle region 3114 approximately at the periphery of the patient's nose, can prevent the propagation of wrinkles formed in the relatively flexible and thin middle region 3114.

[0316] Since the middle region 3114 has a thin wall thickness and can therefore be relatively flexible, the middle region 3114 can be prone to wrinkling. The middle lateral region 3110 can be thicker than the middle region 3114 and can therefore be less prone to wrinkling, particularly at the alar region, which can be more prone to wrinkling due to the complex geometry. If wrinkles start at the surface of the seal-forming structure 3100 that seals with the patient's skin and continue outside the boundaries of the seal, the wrinkles can form a leak path through which gas can leak through the patient's face through the wrinkles into the surrounding environment. This can create noise due to jetting and / or be disturbing due to the feeling of gas flowing along the skin.

[0317] These intermediate lateral regions 3110 can resist wrinkling by virtue of the increased wall thickness. If wrinkles occur in the intermediate region 3114, the intermediate lateral regions 3110 can be able to limit the size of the wrinkles to prevent them from continuing along the sides of the seal-forming structure 3100 and past the surface that forms the seal against the skin. Thus, by configuring the intermediate lateral regions 3110 to be located at or near the edge of the patient's nose wing around the bottom of the nose, the intermediate lateral regions 3110 can act as a barrier to wrinkles that closely follow the shape of the patient's nose.

[0318] In addition, the intermediate lateral region 3110 can provide some intermediate preload to the lateral sides of the seal-forming structure 3100. When the patient puts on the mask, the patient's nose can act against this preload, and the lateral sides of the seal-forming structure 3100 are pushed into the wings of the nose to form a stable and strong seal. The preload can be designed to be large enough so that the seal-forming structure 3100 can fit and form a strong seal with a narrow nose, but not so large that it is uncomfortable or resists sealing against a wider nose. In addition, the preload on the sides of the nose can provide a suspension between the nose and the rest of the seal-forming structure 3100, thereby providing a decoupling effect and allowing some lateral movement of the cushion in use without disrupting the seal.

[0319] 5.3.1.7.7 Patients prefer the sealing and comfort of the sealing structure of this technology

[0320] In an in vitro clinical study, 19 / 23 patients rated the seal-forming structure 3100 of the present technology as having a comfort level higher than 7 on a scale of 1-10, with 10 being the highest. In an in vitro clinical study, 15 / 23 patients rated the seal-forming structure 3100 of the present technology as having a comfort level of 9 or 10.

[0321] In the fitting study, the majority of patients (30 / 33) preferred the initial fitting of the seal-forming structure 3100 of the present technology to a competitive product (Respironics DreamWear) for ease of fitting, adjustment, and seal. 30 of the 33 patients (90%) found the seal-forming structure 3100 of the present technology very easy to fit and adjust.

[0322] 31 of 36 rated the seal of the seal-forming structure 3100 of the present technology as 9 or 10 on a scale of 1-10, with 10 being the highest. In this engineering observational study, patients found that the seal of the seal-forming structure 3100 of the present technology tolerated movement in bed better than a competitor product (espironics DreamWear).

[0323] The majority of patients (31 out of 36 patients) who tested the present technology's seal-forming structures 3100 loved them and would take them home as their mask of choice when compared to a competing product (Respironics DreamWear).

[0324] The comfort preferences described in the preceding paragraphs may be associated with the comfort provided to the patient by the intermediate region 3114, which provides a compliant and consistent engagement with sensitive areas of the patient's face.The overall shape of the exemplary seal-forming structure 3100 may also contribute to comfort.

[0325] The seal preferences described in the preceding paragraphs may be associated with the ability of the medial region 3114 to conform to the patient's nose to form an adequate seal. Furthermore, the medial lateral region 3110, lateral support regions 3108, and corner regions 3115 may also contribute to the preferred seal of the seal-forming structure 3100 of the present technology as these structures engage complex facial geometries to maintain an effective seal.

[0326] 5.3.2 Inflatable chamber

[0327] In the area where the seal is formed in use, the plenum 3200 has a perimeter that is shaped to complement the surface contour of an average human face. In use, the boundary edge of the plenum 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend along the entire perimeter of the plenum 3200 in use. In some forms, the plenum 3200 and the seal-forming structure 3100 are formed from a single homogeneous sheet of material.

[0328] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyelets are outside the pressurized volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable to the wearer, which can improve compliance with treatment.

[0329] In some forms of the present technology, the plenum chamber 3200 is constructed of a transparent material, such as transparent polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with treatment. The use of a transparent material can help the clinician observe how the patient interface is positioned and functioning.

[0330] In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material. The use of a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.

[0331] Figure 22-28 , Fig.35 , Fig.36 , Fig.43 , Fig.44 , Fig.51 and Fig.52 An example of a seal-forming structure 3100 having a plenum chamber 3200 is shown. As described above, the seal-forming structure 3100 can be formed from a single, homogeneous sheet of material (e.g., a liquid silicone rubber sheet) and can include a plenum chamber connection opening 3106, wherein the seal-forming structure 3100 is joined to the plenum chamber 3200. The connection between the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening 3106 can be a permanent bond. The connection between the seal-forming structure 3100 and the plenum chamber 3200 at the plenum chamber connection opening 3106 can be a chemical bond. The seal-forming structure 3100 can be joined to the plenum chamber 3200 at the plenum chamber connection opening 3106 without a mechanical interlock.

[0332] At each lateral side of the plenum 3200, there may be a plenum lateral end 3202 in the form of a hollow passage. A plenum connector 3204 may also be provided on each lateral side of the plenum 3200, laterally outward of the plenum lateral end 3202. The plenum connector 3204 may be connected to a respective end 3314 of the positioning and stabilizing structure 3300. The connection between the plenum connector 3204 and the respective 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 and the other side may have a releasable connection. In further examples, both connections between the plenum connector 3204 and the respective end 3314 of the positioning and stabilizing structure 3300 may be permanent.

[0333] The plenum lateral ends 3202 can receive a flow of pressurized gas from the positioning and stabilizing structure 3300. The flow of pressurized gas can then pass through the plenum 3200, then through the seal-forming structure 3100, and into the patient's airway for inhalation.

[0334] Figure 55-61 Examples of how the ends 3114 of the positioning and stabilizing structure 3300 are connected to the lateral ends 3202 of the plenum chamber are shown. Each of the plenum chamber connectors 3204 in these examples may include a notch 3206 that connects to a clamp protrusion 3322 of a clamp 3320 with a snap fit. Each plenum chamber connector 3204 may be split to allow deformation within the clamp 3320 during the connection process. Each clamp 3320 may be joined to a clamp overmold 3318 that is an intermediate component between the ends 3314 of the positioning and stabilizing structure 3300. Surrounding the ends 3314 of the positioning and stabilizing structure 3300 may be a lip 3324 that seals with the plenum chamber connector 3204. The lip 3324 can surround the entire opening at the end 3314 of the positioning and stabilizing structure 3300 to ensure a complete and airtight seal against the inflation chamber connector end 3204, so that the entire flow of pressurized gas through the positioning and stabilizing structure 3330 reaches the patient via the inflation chamber 3200 and the seal forming structure 3100.

[0335] The plenum connectors 3204 can each include a chamfered edge 3208 and a slot 3209. The chamfered edge 3208 can form a surface for engaging a clamp protrusion 3322 of a clamp 3320, for example, as Fig.57 The slots 3209 can allow the plenum connectors 3204 to deform into a reduced cross-section when inserted into the corresponding fixture 3320.

[0336] The clamp overmold 3318 may be a thin layer of silicone material between the clamp 3320 (e.g., constructed of polycarbonate) and the positioning and stabilizing structure 3300. The clamp overmold 3318 may be constructed of silicone to improve the bond between the positioning and stabilizing structure 3300 and the clamp 3320. The bond between compression grade silicone (e.g., used for the positioning and stabilizing structure 3300) and plastic (such as polycarbonate used for the clamp 332) may be poor. Therefore, a layer of LSR (liquid silicone rubber) in the form of the clamp overmold 3318 may be overmold between the clamp 3320 and the compression grade silicone positioning and stabilizing structure 3300 to improve the bond.

[0337] Fig.56 Also shown is an alignment feature whereby two arrows (one on the plenum 3200 and one on the positioning and stabilizing structure 3300 ) indicate proper engagement of the plenum 3200 with the positioning and stabilizing structure 3300 .

[0338] The plenum connectors 3204 can be chamfered at their ends to provide lead-in angles for connection to the positioning and stabilizing structure 3300. These lead-in features can reduce the force required to insert the plenum connector 3204 into the end 3314 of the positioning and stabilizing structure 3300, particularly the clamp 3320. In addition, the lead-in chamfer on the plenum connector 3204 can facilitate self-alignment with the clamp 3320 during assembly. The clamp 3320 can also have a lead-in chamfer to further help deform the plenum connector 3204 for connection.

[0339] The notch 3206 may be provided to the plenum connector 3204 so that the clamp 3320 fits therein during assembly for a snap-fit ​​connection. Once the clamp 3320 is assembled into the corresponding notch 3206, the plenum 3200 and the positioning and stabilizing structure 3300 are detachably combined. These components can be disconnected by applying enough force to the clamp protrusion 3322 to disengage from the corresponding notch 3206. The edge of each notch 3206 away from the end of the plenum connector 3204 is provided with a surface that is angled relative to the direction in which the plenum 3200 is pulled away from the clamp 3320 during the removal of the plenum 3200 from the positioning and stabilizing structure 3300. The holding angle can provide an optimal force for maintaining the positioning and stabilizing structure 3300 during use while allowing the plenum 3200 to be easily disconnected from the positioning and stabilizing structure 3300. A steeper angle will make the connection safer and avoid unintentional disassembly, but it is more difficult for the patient to disassemble the system. The depicted retention angles will achieve a balance resulting in a secure assembly and easy disassembly.

[0340] The plenum connectors 3204 may be curved to match the curve of the interior contour of the positioning and stabilizing structure 3300 . Fig.57The upper one of the plenum connectors 3204 is curved and does not bend during connection and disconnection. Fig.57 The lower ones of the plenum connectors 3204 do not bend and are able to flex during connection and disconnection to allow the plenum connectors 3204 to fit into the fixture 3320 inside the positioning and stabilizing structure 3300 .

[0341] Providing a sufficient radius of curvature at the base of the split between the plenum connectors 3204 can avoid stress concentrations. Rigid materials (e.g., polycarbonate) would otherwise fail at this location due to the stress created when the bottom of the plenum connector 3204 bends to receive the clamp 3320.

[0342] The cross-sectional profile of the plenum connector 3204 may not strictly follow the cross-sectional profile of the clamp 3320. There may be more clearance at the sides of the plenum connector 3204 than at the top and bottom, which may allow the clamp 3320 to flex during assembly and disassembly without interfering with the plenum connector 3204. When the plenum connector 3204 is pulled from the clamp 3320, the plenum connector 3204 may be pulled against the clamp 3320. Fig.57 Applying force in the up and down directions of the clamp 3320 can cause the sides of the clamp 3320 to be pulled inward as the clamp deforms. Providing some clearance between the sides of the clamp 3320 and the plenum connectors 3204 can allow some room for the sides of the clamp 3320 to move inward without interfering with the plenum connectors 3204. The thickness of the clamp 3320 can be selected to allow for the flexibility and retention required to maintain a secure connection.

[0343] The end 3314 of the positioning and stabilizing structure 3300 may be small enough to form an interference fit with the plenum connector 3204 to seal between the plenum 3200 and the positioning and stabilizing structure 3300. The cross-section of the lip 3324 may be tapered to prevent the lip 3324 from rolling in during assembly, which may adversely affect the seal.

[0344] Fig.60 and Fig.61 It is shown that the internal opening 3201 between the plenum connector 3204 and the interior of the plenum 3200 can have a very similar geometry to the positioning and stabilizing structure 3300, thereby avoiding changes that may adversely affect flow dynamics and cause excessive pressure drop. The transition geometry from the interior of the plenum connector 3204 to the interior of the plenum 3200 and the seal-forming structure 3100 can also minimize pressure drop and impedance.

[0345] 5.3.2.1 Alternative Plenum Chamber Designs

[0346] Figure 64-66 A variation of the plenum 3200 is depicted. In one example, the plenum 3200 can be formed from a flexible material such as silicone rather than a rigid material such as polycarbonate. Thus, the plenum 3200 can be more flexible and can better withstand or separate lateral forces on the positioning and stabilizing structure 3300, which can reduce the forces transmitted to the seal-forming structure 3100 that may damage the seal. The plenum 3200 made of a more flexible material such as silicone can also be more easily removed from the tool during manufacturing. In such an example, the connection to the gas delivery positioning and stabilizing structure 3300 can still be formed from a rigid material, such as polycarbonate.

[0347] In such an instance, the seal-forming structure 3100 can be formed from a very soft silicone, such as in the range of 30-40 Shore durometer. The plenum chamber 3200 can be less soft (but still softer than a rigid material such as polycarbonate), for example, having a hardness in the range of 70-90 durometer. The plenum chamber connectors 3204 can be formed from a hard plastic material, such as polycarbonate or nylon. If the holes are large enough (or the silicone is hard enough), the vents 3400 can be provided as vent holes in the flexible material (e.g., silicone) of the plenum chamber 3200. In such an instance, the holes should be large enough or the material should be sufficient to avoid clogging. Alternatively, the plenum chamber 3200 can be provided with a larger opening into which a plug-in (e.g., a rigid material such as polycarbonate) having the vent holes can be assembled or overmolded. In Fig.62 and Fig.63 This alternative is depicted in The diffuser may also be provided with a vent insert 3242 or in addition to the vent insert 3242 .

[0348] Figure 64-66 An example is depicted in which the plenum 3200 is divided into two plenum sections 3260 separated by a flexible material like silicone. Thus, the plenum 3200 can flex in the center. This can provide some decoupling of forces between the positioning and stabilizing structure 3300 and the seal-forming structure 3100, and can also allow the seal-forming structure 3100 to deform and wrap around the patient's face. Each plenum section 3260 can be connected to the positioning and stabilizing structure 3300 to direct gas into the plenum 3200. These plenum sections 3260 can also include vents 3400.

[0349] 5.3.3 Positioning and stabilizing the structure

[0350] The seal-forming structure 3100 of the patient interface 3000 of the present technology may be maintained in a sealed state during use by the positioning and stabilizing structure 3300 .

[0351] In one form, the positioning and stabilising structure 3300 provides a retaining force that is at least sufficient to overcome the positive pressure in the plenum 3200 to lift off the face.

[0352] In one form, the positioning and stabilising structure 3300 provides a retaining force to overcome the effects of gravity on the patient interface 3000 .

[0353] In one form, the positioning and stabilising structure 3300 provides a retaining force as a safety margin to overcome the potential effects of damaging forces on the patient interface 3000, for example, from tube drag or accidental interference with the patient interface.

[0354] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is constructed in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a small side or cross-sectional thickness to reduce the sensed or actual volume of the instrument. In one example, the positioning and stabilizing structure 3300 includes at least one strap that is rectangular in cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0355] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a supine sleeping position with the back area of ​​the patient's head on a pillow.

[0356] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a side sleeping position with the side area of ​​the patient's head on a pillow.

[0357] In one form of the present technology, the positioning and stabilising structure 3300 is provided with a decoupling portion between the front of the positioning and stabilising structure 3300 and the back of the positioning and stabilising structure 3300. The decoupling portion does not resist compression and may be, for example, a flexible band or soft strap. The decoupling portion is constructed and arranged such that when a patient lies their head on a pillow, the presence of the decoupling portion prevents forces acting on the back from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.

[0358] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a strap constructed from a laminate of a fabric patient contacting 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 comprises a loop material for engaging with a hook material portion.

[0359] In some forms of the present technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For example, the strap can be configured to be in tension when in use and to direct a force to bring the seal-forming structure into sealing contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0360] In one form of the present technology, the positioning and stabilizing structure includes a first strap that is constructed and arranged so that in use at least a portion of a lower edge of the first strap passes through the supraauricular base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0361] In one form of the present technology applicable to a nasal-only mask or to a full-face mask, the positioning and stabilizing structure includes a second strap that is constructed and arranged so that in use at least a portion of an upper edge of the second strap passes below the subauricular base of the patient's head and covers or is located below the occipital bone of the patient's head.

[0362] In one form of the present technology suitable for use with a nasal-only mask or with a full-face mask, the positioning and stabilizing structure includes a third strap constructed and arranged to interconnect the first strap and the second strap to reduce the tendency of the first strap and the second strap to separate from each other.

[0363] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a strap that is flexible and, for example, non-rigid. An advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0364] In some forms of the present technology, the positioning and stabilising structure 3300 comprises a belt that is configured to be breathable to allow moisture vapor to be transmitted through the belt.

[0365] In some forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each positioning and stabilizing structure configured to provide retention forces to correspond to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large sized heads but not for small sized heads, while another form of positioning and stabilizing structure is suitable for small sized heads but not for large sized heads.

[0366] 5.3.3.1 Positioning and stable structure of this technology

[0367] Figure 7-15Examples of the present technology are depicted, including a positioning and stabilizing structure 3300. In these examples, the positioning and stabilizing structure 3300 includes a lateral portion 3302 and an upper portion 3304 in the form of a conduit or tube that directs the pressurized air flow from a hub 3306 to an end 3314. The positioning and stabilizing structure 3300 can be arranged so that the hub 3306 and the decoupling structure 3500 are positioned above the patient's head in use. As described below, the decoupling structure 3500 can rotate within the hub 3306, and when the patient interface 3000 is worn by the patient, for example, during treatment, the position of the hub 3306 and the decoupling structure 3500 above the patient's head allows the patient to move more freely without becoming entangled with the air circuit 4170.

[0368] The positioning and stabilizing structure 3300 can be constructed from silicone. For example, the lateral portion 3302, the upper portion 3304, the hub 3306, and the lateral end portions 3314 can be constructed or molded from a single piece of silicone.

[0369] The upper portion 3304 of the positioning and stabilizing structure 3300 has ridges and valleys (or bellows-like sections) that allow the upper portion 3304 to conform to the shape of a corresponding portion of a patient's head in use. The ridges and valleys 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 ridges and valleys of the upper portion 3304 allow the upper portion 3304 to flex to different radii of curvature to accommodate patient heads of different shapes and sizes.

[0370] The lateral portion 3302 portion of the positioning and stabilizing structure 3300 may not be formed with the ridges and valleys of the upper portion 3304. Thus, the lateral portion 3302 may be less malleable and flexible than the upper portion 3304, which may be advantageous because there is less variability in the shape and size of the side of a patient's head.

[0371] The end 3314 can be connected to the corresponding plenum lateral end 3202. As described above, the plenum lateral end 3202 receives a flow of pressurized gas from the positioning and stabilizing structure 3300, which passes through the plenum 3200, through the seal-forming structure 3100, and reaches the patient's airway. As described above, the end 3314 can include a clamp overmold 3318 and a clamp 3320 that facilitates the connection of the end 3314 to the plenum connector 3204 of the corresponding plenum lateral end portion 3202.

[0372] The lateral portions 3302 may also each include a tab 3308 that receives a rear strap end 3311 of the rear strap 3310. The rear strap 3310 may be adjustable in length, for example, by a hook and loop material arrangement such that one of the rear strap end 3311 and the remainder of the rear strap 3310 includes a hook material on its exterior and the other includes a loop material on its exterior. The length adjustability of the rear strap 3310 allows the tension on the lateral portions 3302 to be increased to pull the seal-forming structure 3100 into sealing engagement with the patient's face at a desired pressure (i.e., sufficiently tight to avoid leakage, while not too tight to cause discomfort).

[0373] The lateral portion 3302 may also be provided with a sleeve 3312 that cushions the impact of the patient's face against the lateral portion 3302. The sleeve 3312 may be constructed of a breathable fabric material having a soft touch.

[0374] 5.3.4 Ventilation

[0375] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide.

[0376] In some forms, the vent 3400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 3200 to the surrounding environment while the pressure within the plenum chamber is positive relative to the surrounding environment. The vent 3400 is configured so that the vent flow has a sufficient amplitude to reduce the patient's rebreathing of exhaled CO2 while maintaining a therapeutic pressure in the plenum chamber during use.

[0377] One form of a 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.

[0378] The vent 3400 may be located in the plenum 3200. The plenum vent 3400 may include a plurality of holes, as described above. The holes of the plenum vent 3400 may be divided into two groups spaced laterally apart. The axes of the flow paths through each hole of the plenum vent 3400 may be parallel to avoid cross flow to prevent the generation of additional noise. The vent holes may be circular.

[0379] Fig.54It is also shown that the holes of the plenum vent 3400 can decrease in radius from the inside to the outside of the plenum 3200. As shown, each vent hole has a draft angle. The diameter of each hole at its front end is smaller than the diameter at its rear end. This draft angle means that the holes do not have a small cross-section throughout the thickness of the chassis, which helps to provide effective carbon dioxide flushing at high humidification levels. In addition, a larger draft angle can cause the plenum 3200 to be easier to manufacture, especially when the plenum 3200 is formed from an injection molded plastic material. The draft angle makes the vent pin used in the mold thicker and easier to eject.

[0380] The holes of the plenum vent 3400 may be provided in two groups toward the middle of the plenum 3200 and the groups may be symmetrical across the centerline of the plenum 3200. Providing a pattern of multiple vent holes may reduce noise and diffuse flow concentration.

[0381] The holes of the plenum vent 3400 can be placed at an optimal distance from the centerline of the plenum 3200. Placing the holes of the plenum vent 3400 toward the centerline can advantageously reduce the chance of the vent becoming blocked when the patient sleeps on his side. However, placing these vent holes too close to the middle of the plenum 3200 can result in excessive weakening of the plenum 3200 at the center, especially because the cross-section of the plenum 3200 in the depicted example is smallest at the center due to the overall shape of the plenum 3200. The location of the holes of the plenum vent 3400 can avoid blockage of the holes during side sleeping while making the middle portion of the chassis sufficiently strong.

[0382] The size of each vent hole and the number of vent holes can be optimized to achieve a balance between noise reduction, even during extreme humidification, while achieving necessary carbon dioxide removal. In the depicted example, the vent holes of the plenum chamber vent 3400 may not provide the total amount of vent for the system. The decoupling structure 3500 may include a decoupling structure vent 3402. The decoupling structure vent 3402 may include a hole or multiple holes passing through the decoupling structure 3500. The decoupling structure vent 3402 can be used to vent overpressure generated by the RPT device 4000 before reaching the patient, while the plenum chamber vent 3400 can be used to flush carbon dioxide exhaled by the patient during treatment.

[0383] Fig.62 and Fig.63 An alternative example of a plenum vent 3400 is shown in which the apertures are provided to a vent insert 3242 that is attached to the plenum 3200 at the vent insert opening 3240. The vent insert 3242 may be constructed of a material that is more flexible than the material of the plenum 3200.

[0384] 5.3.5 Decoupling Structure

[0385] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0386] The hub 3306 described above is connected to the decoupling structure 3500, which is a rotatable elbow in these examples. The decoupling structure 3500 can be rotated 360° in the hub 3306 during use. The decoupling structure 3500 can be removable from the hub 3306 by manually pressing the button 3504 to release the clip (not shown) from the hub 3306.

[0387] The decoupling structure 3500 may also include a swivel 3502 that allows for a rotatable connection to the air circuit 4170 .

[0388] The rotatability of the decoupling structure 3500 , the bent tube form of the decoupling structure 3500 , and the rotatability of the swivel 3502 on the decoupling structure 3500 may increase degrees of freedom, which in turn reduces tube drag and torque on the patient interface 3000 caused by the connection to the air circuit 4170 .

[0389] 5.3.6 Connection Port

[0390] The connection port 3600 allows connection to the air circuit 4170 .

[0391] 5.3.7 Forehead support

[0392] In one form, the patient interface 3000 includes a forehead support 3700 .

[0393] 5.3.8 Anti-asphyxia valve

[0394] In one form, patient interface 3000 includes an anti-asphyxia valve.

[0395] 5.3.9 Ports

[0396] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the plenum chamber 3200, such as pressure.

[0397] 5.4RPT device

[0398] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to execute one or more algorithms 4300, e.g., any of the methods described herein in whole or in part. The RPT device 4000 can be configured to generate an air flow for delivery to the airway of a patient, e.g., for treating one or more respiratory conditions described elsewhere in this document.

[0399] In one form, the RPT device 4000 is constructed and arranged to deliver air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0400] The RPT device can have an outer housing 4010 that is constructed in two parts: an upper portion 4012 and a lower portion 4014. In addition, the outer housing 4010 can include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 can include a handle 4018.

[0401] The pneumatic path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at a positive pressure, an outlet muffler 4124, and one or more converters 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0402] One or more air path items may be disposed within a removable separate structure, which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by, or forms part of, the chassis 4016.

[0403] The RPT device 4000 may have a power source 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a converter 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0404] 5.4.1 Mechanical and pneumatic components of the RPT device

[0405] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be provided as separate units.

[0406] 5.4.1.1 Air filter

[0407] An RPT device according to one form of the present technology may include an air filter 4110, or multiple air filters 4110.

[0408] In one form, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140 .

[0409] In one form, an outlet air filter 4114 , eg, an antimicrobial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 .

[0410] 5.4.1.2 Silencer

[0411] An RPT device according to one form of the present technology may include a silencer 4120 , or a plurality of silencers 4120 .

[0412] In one form of the present technology, the inlet muffler 4122 is positioned in the pneumatic path upstream of the pressure generator 4140 .

[0413] In one form of the present technology, an outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000 .

[0414] 5.4.1.3 Pressure generator

[0415] In one form of the present technology, the pressure generator 4140 for generating an air flow or air supply under positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. The blower may, for example, deliver an air supply at a rate of up to about 120 liters per minute and at a positive pressure in the range of about 4 cm H2O to about 20 cmH2O or in other forms up to about 30 cmH2O. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO2013 / 020167.

[0416] The pressure generator 4140 is under the control of the treatment device controller 4240.

[0417] In other words, the pressure generator 4140 may be a piston driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows.

[0418] 5.4.1.4 Converter

[0419] The transducer may be internal to the RPT device, or external to the RPT device. An external transducer may be located, for example, on or form part of an air circuit, for example, a patient interface. An external transducer may be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.

[0420] In one form of the present technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal representative of a characteristic of the air flow at that point in the pneumatic path, such as flow, pressure or temperature.

[0421] In one form of the present technology, one or more transducers 4270 may be positioned proximal to the patient interface 3000 .

[0422] In one form, the signal from converter 4270 may be filtered, such as by low pass filtering, high pass filtering, or band pass filtering.

[0423] 5.4.1.4.1 Flow sensor

[0424] A flow sensor 4274 according to the present technology may be based on a differential pressure transducer, such as the SDP600 series differential pressure transducer from SENSIRION.

[0425] In one form, a signal representing flow from flow sensor 4274 is received by central controller 4230.

[0426] 5.4.1.4.2 Pressure sensor

[0427] A pressure sensor 4272 according to the present technology is positioned in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a transducer from the ASDX series of HONEYWELL. An alternative suitable pressure sensor is a transducer from the NPA series of GENERALELECTRIC.

[0428] In one form, signals from pressure sensor 4272 may be received by central controller 4230 .

[0429] 5.4.1.4.3 Motor speed converter

[0430] In one form of the present technology, a motor speed converter 4276 is used to determine the rotational speed of the motor 4144 and / or blower 4142. A motor speed signal from the motor speed converter 4276 may be provided to the treatment device controller 4240. The motor speed converter 4276 may be, for example, a speed sensor such as a Hall effect sensor.

[0431] 5.4.1.5 Anti-overflow valve

[0432] In one form of the present technology, an anti-spillback valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0433] 5.4.2 RPT device electrical components

[0434] 5.4.2.1 Power supply

[0435] The power source 4210 may be positioned inside or outside of the outer housing 4010 of the RPT device 4000 .

[0436] In one form of the present technology, power supply 4210 provides power only to RPT device 4000. In another form of the present technology, power supply 4210 provides power to both RPT device 4000 and humidifier 5000.

[0437] 5.4.2.2 Input device

[0438] In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow a person to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessed via a touch screen. In one form, the buttons, switches, or dials may be physically connected to the external housing 4010, or in another form, may be in wireless communication with a receiver that is electrically connected to a central controller 4230.

[0439] In one form, input device 4220 may be constructed or arranged to allow a person to select values ​​and / or menu options.

[0440] 5.4.2.3 Central Controller

[0441] In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0442] Suitable processors may include x86 Intel processors, A processor of a processor such as the STM32 series microcontroller from ST MICROELECTRONIC. In some alternative forms of the present technology, a 32-bit RISC CPU such as the STR9 series microcontroller from ST MICROELECTRONICS, or a 16-bit RISC CPU such as the MSP430 series microcontroller from TEXAS INSTRUMENTS may also be suitable.

[0443] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0444] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0445] The central controller 4230 may be configured to receive input signals from one or more converters 4270 , one or more input devices 4220 , and the humidifier 5000 .

[0446] The central controller 4230 may be configured to provide output signals to one or more output devices 4290 , the treatment device controller 4240 , the data communication interface 4280 , and the humidifier 5000 .

[0447] In some forms of the present technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 represented as computer programs stored in a non-transitory computer readable storage medium such as memory 4260. In some forms of the present technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of the present technology, some of the methods may be performed by a remotely located device. For example, the remotely located device may determine a control set point for the ventilator or detect a breathing-related event by analyzing stored data such as from any of the sensors described herein.

[0448] 5.4.2.4 Clock

[0449] The RPT device 4000 may include a clock 4232 connected to a central controller 4230 .

[0450] 5.4.2.5 Treatment device controller

[0451] In one form of the present technology, the treatment device controller 4240 is a treatment control module 4330 that forms part of the algorithm 4300 executed by the central controller 4230.

[0452] In one form of the present technology, the treatment device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, the MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0453] 5.4.2.6 Protection circuit

[0454] One or more protection circuits 4250 in accordance with the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0455] 5.4.2.7 Memory

[0456] According to one form of the present technology, the RPT device 4000 includes memory 4260, for example, non-volatile memory. In some forms, the memory 4260 may include battery-powered static RAM. In some forms, the memory 4260 may include volatile RAM.

[0457] Memory 4260 may be located on PCBA 4202. Memory 4260 may be in the form of EEPROM or NAND flash memory.

[0458] Additionally or alternatively, the RPT device 4000 includes memory 4260 in a removable form, such as a memory card made in accordance with the Secure Digital (SD) standard.

[0459] In one form of the present technology, the memory 4260 serves as a non-transitory computer-readable storage medium on which are stored computer program instructions representing one or more of the methods described herein, such as one or more algorithms 4300 .

[0460] 5.4.2.8 Data Communication System

[0461] In one form of the present technology, a data communication interface 4280 is provided and connected to the central controller 4230. The data communication interface 4280 may be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connected to a remote external device 4286. The local external communication network 4284 may be connected to a local external device 4288.

[0462] In one form, the data communications interface 4280 is part of the central controller 4230. In another form, the data communications interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.

[0463] In one form, remote external communication network 4282 is the Internet. Data communication interface 4280 may connect to the Internet using wired communication (eg, via Ethernet or fiber optic) or wireless protocols (eg, CDMA, GSM, LTE).

[0464] In one form, the local external communications network 4284 utilizes one or more communications standards, such as Bluetooth or consumer infrared protocols.

[0465] In one form, the remote external device 4286 can be one or more computers, for example, a cluster of network computers. In one form, the remote external device 4286 can be a virtual computer rather than a physical computer. In either case, this remote external device 4286 can be accessed by appropriately authorized personnel (such as a clinician).

[0466] The local external device 4288 may be a personal computer, a mobile phone, a tablet or a remote control device.

[0467] 5.4.2.9 Output devices including optional displays and alarms

[0468] Output devices 4290 according to the present technology may take the form of one or more of visual, audio, and tactile units.The visual display may be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0469] 5.4.2.9.1 Display Driver

[0470] The display driver 4292 receives as input characters, symbols, or images for display on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols, or images.

[0471] 5.4.2.9.2 Display

[0472] The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an eight-segment display, in which case the display driver 4292 converts each character or symbol (such as the number "0") into eight logic signals that indicate whether the eight corresponding segments are to be activated to display the particular character or symbol.

[0473] 5.5 Air circuit

[0474] The air circuit 4170 according to one aspect of the present technology is a conduit or tube that, when in use, is constructed and arranged to allow air flow to travel between two components, such as the RPT device 4000 and the patient interface 3000 .

[0475] Specifically, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there can be separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.

[0476] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example, to maintain or increase the temperature of the air. The heating element may be in the form of a heating wire loop and may include one or more transducers, such as a temperature sensor. In one form, the heating wire loop may be helically wound around the axis of the air circuit 4170. The heating element may be in communication with a controller such as a central controller 4230. An example of an air circuit 4170 including a heating wire loop is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0477] 5.5.1 Oxygen delivery

[0478] In one form of the present technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic pathway, such as upstream of the pneumatic block 4020 , the air circuit 4170 , and / or the patient interface 3000 .

[0479] 5.6 Humidifier

[0480] 5.6.1 Humidifier Overview

[0481] In one form of the present technology, a humidifier 5000 (e.g., Figure 5A ) to change the absolute humidity of the air or gas for delivery to the patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the air flow and increase the temperature of the air flow (relative to the ambient air) before delivery to the patient's airway.

[0482] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering a humidified air flow. Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 can also include a humidifier base 5006, which can be adapted to receive the humidifier reservoir 5110 and include a heating element 5240.

[0483] 5.6.2 Humidifier components

[0484] 5.6.2.1 Water storage tank

[0485] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to hold or retain a liquid (e.g., water) volume to be evaporated for humidifying the air flow. The water reservoir 5110 may be configured to hold a predetermined maximum water volume so as to provide sufficient humidification for at least the duration of a respiratory therapy session, such as one night of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 milliliters (ml), 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source such as a building's water supply system.

[0486] According to one aspect, water reservoir 5110 is configured to humidify air flow from RPT device 4000 as the air flow travels therethrough. In one form, water reservoir 5110 may be configured to encourage air flow to travel in a tortuous path through reservoir 5110 while in contact with the volume of water therein.

[0487] According to one form, the reservoir 5110 may be, for example, along Figure 5A and Figure 5B The lateral orientation is shown removed from the humidifier 5000.

[0488] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any holes and / or between its subcomponents, such as when the reservoir 5110 is displaced and / or rotated from its normal working orientation. Since the air flow to be humidified by the humidifier 5000 is generally pressurized, the reservoir 5110 may also be configured to avoid loss of pneumatic pressure through leakage and / or flow resistance.

[0489] 5.6.2.2 Conductive part

[0490] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 that is configured to allow efficient transfer of heat from the heating element 5240 to the liquid content in the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes may also be equally suitable. All or a portion of the conductive portion 5120 may be made of a thermally conductive material, such as aluminum (e.g., having a thickness of approximately 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, a material with a suitable geometry having a lower conductivity may be used to achieve appropriate thermal conductivity.

[0491] 5.6.2.3 Humidifier reservoir dock

[0492] In one form, the humidifier 5000 may include a humidifier reservoir base 5130 (eg, Figure 5B), which is configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include a locking structure, such as a locking rod 5135 configured to hold the reservoir 5110 in the humidifier reservoir base 5130.

[0493] 5.6.2.4 Water level indicator

[0494] The humidifier reservoir 5110 may include Figure 5A-5B 1000 or a caregiver. The water level indicator 5150 is shown. In some forms, the water level indicator 5150 may provide a user (such as the patient 1000 or a caregiver) with one or more indications regarding the amount of water volume in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of a maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0495] 5.6.2.5 Humidifier converter

[0496] The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of or in addition to the transducers 4270 described above. Figure 5C As shown, the humidifier converter 5210 may include one or more of an air pressure sensor 5212, an air flow converter 5214, a temperature sensor 5216, or a humidity sensor 5218. The humidifier converter 5210 may generate one or more output signals that may be communicated to a controller, such as the central controller 4230 and / or the humidifier controller 5250. In some forms, the humidifier converter may be provided externally to the humidifier 5000 (such as in the air circuit 4170) when communicating the output signals to the controller.

[0497] 5.6.2.5.1 Pressure converter

[0498] In lieu of or in addition to the pressure sensor 4272 provided in the RPT device 4000 , one or more pressure transducers 5212 may be provided to the humidifier 5000 .

[0499] 5.6.2.5.2 Flow converter

[0500] As an alternative or in addition to the flow sensor 4274 provided in the RPT device 4000, one or more flow transducers 5214 may be provided to the humidifier 5000.

[0501] 5.6.2.5.3 Temperature converter

[0502] The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures, such as the temperature of the heating element 5240 and / or the air flow downstream of the humidifier outlet 5004. In some forms, the humidifier 5000 may further include a temperature sensor 5216 for detecting the ambient air temperature.

[0503] 5.6.2.5.4 Humidity converter

[0504] In some forms, the humidifier 5000 may include one or more humidity sensors 5218 that detect the humidity of a gas (such as ambient air). In some forms, the humidity sensor 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.

[0505] 5.6.2.6 Heating elements

[0506] In some cases, a heating element 5240 can be provided to the humidifier 5000 to provide heat input to one or more of the water volumes in the humidifier reservoir 5110 and / or to the air flow. The heating element 5240 can include a heat generating component, such as a resistive electric heating rail. A suitable example of a heating element 5240 is a layered heating element, such as the layered heating element described in PCT Patent Application Publication No. WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0507] In some forms, the heating element 5240 may be disposed in the humidifier base 5006, such as Figure 5B As shown in , heat can be provided to the humidifier reservoir 5110 primarily by conduction.

[0508] 5.6.2.7 Humidifier controller

[0509] According to one arrangement of the present technology, Figure 5C The humidifier 5000 shown in FIG. 5 may include a humidifier controller 5250. In one form, the humidifier controller 5250 may be part of the central controller 4230. In another form, the humidifier controller 5250 may be a separate controller that may communicate with the central controller 4230.

[0510] In one form, the humidifier controller 5250 may receive as input, for example, measurements of characteristics of the air flow, water flow (such as temperature, humidity, pressure and / or flow) in the reservoir 5110 and / or the humidifier 5000. The humidifier controller 5250 may also be configured to execute or implement a humidifier algorithm and / or deliver one or more output signals.

[0511] like Figure 5C As shown in , the humidifier controller 5250 may include one or more controllers, such as a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240.

[0512] 5.7 Respiratory waveform

[0513] Figure 6 A typical breathing waveform of a model of a person during sleep is shown. The horizontal axis is time and the vertical axis is respiratory flow. Although the parameter values ​​can vary, a typical breath can have the following approximate values: tidal volume Vt 0.5L, inspiratory time Ti 1.6s, inspiratory peak flow Qpeak 0.4L / s, expiratory time Te 2.4s, expiratory peak flow Qpeak-0.5L / s. The total duration of the breath Ttot is about 4s. People usually breathe at a rate of about 15 breaths per minute (BPM) and about 7.5L / min at the ventilation outlet. The typical duty cycle, the ratio of Ti to Ttot is about 40%.

[0514] 5.8 Glossary

[0515] For purposes of this technical disclosure, in certain forms of the technology, one or more of the following definitions may apply. In other forms of the technology, alternative definitions may apply.

[0516] 5.8.1 General

[0517] Air: In some forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, for example, atmospheric air enriched with oxygen.

[0518] Environment: In certain forms of the present technology, the term environment can have the meaning of (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0519] For example, the ambient humidity relative to the humidifier may be the humidity of the air directly surrounding the humidifier, for example, the humidity within the room that the patient is sleeping in. This ambient humidity may be different from the humidity outside the room that the patient is sleeping in.

[0520] In another example, ambient pressure can be the pressure immediately surrounding or external to the body.

[0521] In some forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room the patient is in, in addition to noise generated, for example, by the RPT device or from a mask or patient interface. Ambient noise may be generated by sound sources outside the room.

[0522] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the therapy pressure is automatically adjustable between a minimum and a maximum limit, e.g., with each breath, depending on whether there is an indication of a SDB event.

[0523] Continuous Positive Airway Pressure (CPAP) therapy: A breathing pressure therapy in which the therapy pressure can be approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction, and decreasing in the absence of an indication of partial upper airway obstruction.

[0524] Flow: The instantaneous volume (or mass) of air delivered per unit time. Flow may refer to an instantaneous quantity. In some cases, reference to flow will be to a scalar quantity, i.e., a quantity having only magnitude. In other cases, reference to flow will be to a vector quantity, i.e., a quantity having both magnitude and direction. Flow may be given the symbol Q. "Flow" is sometimes shortened to simply "flow" or "air flow".

[0525] In the example of a patient breathing, the flow may be nominally positive for the inspiratory portion of the patient's breathing cycle, and therefore negative for the expiratory portion of the patient's breathing cycle. The total flow, Qt, is the air flow leaving the RPT device. The ventilation flow, Qv, is the air flow leaving the vent to allow for flushing of exhaled gases. The leakage flow, Ql, is the leakage flow from the patient interface system or elsewhere. The respiratory flow, Qr, is the air flow received into the patient's respiratory system.

[0526] Humidifier: The term humidifier shall be deemed to refer to a humidifying device constructed and arranged or configured with a physical structure capable of providing therapeutically beneficial amounts of water (H2O) vapor to an air flow to improve a patient's medical respiratory condition.

[0527] Leakage: The word leakage is to be considered as undesired air flow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in the return elbow to the ambient environment.

[0528] Noise, conducted (acoustic): Conducted noise in this document refers to the noise brought to the patient through the pneumatic path (such as the air circuit and patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0529] Noise radiated (acoustic): Radiated noise in this document refers to the noise that is brought to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0530] Noise, Ventilation (Acoustic): Ventilation noise in this document refers to the noise generated by the flow of air through any vent, such as the vent holes of a patient interface.

[0531] Patient: A person, whether or not they have a respiratory condition.

[0532] Pressure: Force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm 2 and hectopascal. 1cmH2O is equal to 1g-f / cm 2 , is about 0.98 hectares. In this specification, unless otherwise specified, the pressure is given in cmH2O.

[0533] The pressure in the patient interface is given the symbol Pm, while the therapy pressure is given the symbol Pt, which represents the target value to be achieved by the mask pressure Pm at the current moment.

[0534] Respiratory Pressure Therapy (RPT): The application of a supply of air to the airway entrance at a therapeutic pressure that is typically positive relative to atmosphere.

[0535] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0536] 5.8.1.1 Materials

[0537] Silicone or Silicone Elastomer: Synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0538] Polycarbonate: A transparent thermoplastic polymer of bisphenol A carbonate.

[0539] 5.8.1.2 Mechanical properties

[0540] Resilience: The ability of a material to absorb energy when elastically deformed and release that energy when unloaded.

[0541] Elastic: Will release substantially all of its energy when unloaded. Includes, for example, certain silicones and thermoplastic elastomers.

[0542] Hardness: The ability of a material to resist deformation inherently (e.g., as described by Young's modulus or the indentation hardness scale measured on a standardized sample size).

[0543] "Soft" materials may include silicone or thermoplastic elastomers (TPE), and may deform easily, for example, under finger pressure.

[0544] "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and may not deform easily, for example, under finger pressure.

[0545] Stiffness (or rigidity) of a structure or component: The ability of the structure or component to resist deformation in response to an applied load. The load can be a force or a moment, for example, compression, tension, bending or torsion. The structure or component can provide different resistance in different directions.

[0546] Flexible structure or component: A structure or component that will change shape (eg, bend) when made to support its own weight for a relatively short period of time, eg, within 1 second.

[0547] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads normally encountered in use. Examples of such use may be, for example, positioning and maintaining a patient interface in sealing relationship with the entrance to a patient's airway at a pressure of about 20 to 30 cmH2O.

[0548] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in a first direction than in a second orthogonal direction. In another example, a structure or component may be flexible in a first direction and rigid in a second direction.

[0549] 5.8.2 Breathing cycle

[0550] Apnea: According to some definitions, an apnea is considered to occur when flow drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway does not allow air to flow despite the patient's efforts. Central apnea is considered to occur when an apnea is detected due to a decrease or absence of respiratory effort despite a patent airway. Mixed apnea is considered to occur when a decrease or absence of respiratory effort occurs simultaneously with an obstructed airway.

[0551] Respiratory Rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0552] Duty cycle: the ratio of inspiratory time Ti to total breathing time Ttot.

[0553] Effort (breathing): The work done by a spontaneously breathing person trying to breathe.

[0554] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0555] Flow Limitation: Flow limitation is to be considered a state in a patient's breathing where an increase in the patient's effort does not result in a corresponding increase in flow. Where flow limitation occurs during the inspiratory portion of the breathing cycle, it may be described as inspiratory flow limitation. Where flow limitation occurs during the expiratory portion of the breathing cycle, it may be described as expiratory flow limitation.

[0556] Types of flow-limited inspiratory waveforms:

[0557] (i) Flattened: Having a rise followed by a relatively flat portion and then a fall.

[0558] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, with a relatively flat portion between the two peaks.

[0559] (iii) Chair shape: has a single local peak at the leading edge followed by a relatively flat section.

[0560] (iv) Reverse chair shape: has a relatively flat section followed by a single local peak located at the trailing edge.

[0561] Hypopnea: Preferably, hypopnea will be considered a decrease in flow, rather than a cessation of flow. In one form, hypopnea is considered to occur when flow drops below a threshold for a sustained period of time. Central hypopnea is considered to occur when hypopnea is detected due to a decrease in respiratory effort. In one form in adults, any of the following may be considered hypopnea:

[0562] (i) The patient's respiration decreases by 30% for at least 10 seconds with an associated 4% desaturation; or

[0563] (ii) The patient has a decrease in breathing (but less than 50%) lasting at least 10 seconds with an associated desaturation or arousal of at least 3%.

[0564] Hyperpnea: Increased air flow to above normal levels.

[0565] Inspiratory portion of the respiratory cycle: The period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0566]

[00136] Patency (airway): The degree to which an airway is open or the degree to which an airway is open. An open airway is open. Airway patency can be quantified, for example, with a value (1) for open, and a value of zero (0) for closed (obstructed).

[0567] Positive End Expiratory Pressure (PEEP): The pressure above atmospheric pressure that exists in the lungs at the end of exhalation.

[0568] Peak Flow (Q Peak): The maximum value of the flow during the inspiratory portion of the respiratory flow waveform.

[0569] Respiratory flow, patient airflow, respiratory airflow (Qr): These terms may be understood to refer to the RPT device's estimate of respiratory flow, in contrast to "true respiratory flow" or "real respiratory flow", which is the actual respiratory flow experienced by the patient, usually expressed in liters / minute.

[0570] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing when no additional effort is exerted. In principle, the inspiratory volume Vi (the volume of air inhaled) is equal to the expiratory volume Ve (the volume of air exhaled), so a single tidal volume Vt can be defined to be equal to either volume. In practice, the tidal volume Vt is estimated as some combination of the inspiratory volume Vi and the expiratory volume Ve, e.g., an average value.

[0571] (Inspiratory) Time (Ti): Duration of the inspiratory portion of the respiratory flow waveform.

[0572] (Expiratory) Time (Te): Duration of the expiratory portion of the respiratory flow waveform.

[0573] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of one respiratory flow waveform and the start of the inspiratory portion of the subsequent respiratory flow waveform.

[0574] Typical Recent Ventilation: The ventilation value around which recent values ​​tend to cluster within some predetermined timescale ventilation ventilator, ie, a measure of the central tendency of recent ventilation values.

[0575] Upper airway obstruction (UAO): includes partial and total upper airway obstruction. This may be associated with a state of flow limitation, where the flow level increases only slightly, or even decreases, as the pressure difference across the upper airway increases (Starling impedance behavior).

[0576] Ventilation (Vent): A measurement of the total amount of gas exchanged by a patient's respiratory system. Measurements of ventilation may include one or both of inspiratory and expiratory flow (per unit time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation is sometimes given simply as volume, and is understood to be the volume per minute.

[0577] 5.8.3 Ventilation

[0578] Adaptive servo ventilator (ASV): A servo ventilator with a variable rather than fixed target ventilation. The variable target ventilation may be known from some characteristics of the patient (e.g., the patient's breathing characteristics).

[0579] Backup Rate: A parameter of a ventilator that determines the minimum rate of breaths (usually measured in breaths per minute) that the ventilator will deliver to the patient if not triggered by a spontaneous respiratory effort.

[0580] Cyclic: The termination of the inspiratory phase of a ventilator. When a ventilator is delivering a breath to a spontaneously breathing patient, at the end of the inspiratory portion of the respiratory cycle, the ventilator is considered to cycle to stop delivering a breath.

[0581] Expiratory Positive Airway Pressure (EPAP): The base pressure to which the intra-breath varying pressures are added to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0582] End-expiratory pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory portion. If the pressure waveform template P(F) is zero at the end of exhalation, that is, P(F) = 0SF = 1, then EEP is equal to EPAP.

[0583] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of a breath.

[0584] Pressure Support: A number that indicates the increase in pressure during ventilator inspiration over the pressure during ventilator expiration, and usually means the difference in pressure between the maximum during inspiration and the base pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support means the difference that the ventilator aims to achieve, rather than the difference that is actually achieved.

[0585] Servomotor: A ventilator that measures patient ventilation, has a target ventilation and adjusts the level of pressure support to bring the patient's ventilation to the target ventilation.

[0586] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath in a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined period of time, the device will automatically initiate the delivery of a breath.

[0587] Swing: A term equivalent to pressure support.

[0588] Triggered: When the ventilator delivers breathed air to a spontaneously breathing patient, it is considered to be triggered at the beginning of the breath portion of the breathing cycle through the patient's effort.

[0589] 5.8.4 Anatomy

[0590] 5.8.4.1 Facial anatomy

[0591] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0592] Alar tip: The outermost point on the wing of the nose.

[0593] Alar bend (or alar apex) point: The most posterior point in the base line of the curvature of each ala, found in the crease formed by the union of the ala and cheek.

[0594] Auricle: The entire external visible part of the ear.

[0595] (Nose) Framework: The nasal framework includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0596] (Nose) Soft skeleton: The nasal soft skeleton includes the septal, lateral, major and minor cartilages.

[0597] Columella: The strip of skin that separates the nostrils and extends from the nasal prominence to the upper lip.

[0598] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (where both lines intersect at the lower point of the nasal septum).

[0599] Frankfurt horizontal plane: A line extending from the lowest point of the orbital rim to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0600] Glabella: Located on the soft tissue, the most prominent point in the midsagittal plane of the nasal protuberance.

[0601] External nasal cartilage: A generally triangular plate of cartilage with its superior margin attached to the nasal bones and the frontal process of the maxilla, and its inferior margin connected to the greater alar cartilage.

[0602] Greater alar cartilage: A cartilaginous plate located beneath the lateral nasal cartilage. It curves around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four small cartilages of the alar nasal cavity.

[0603] Nare: The approximately oval-shaped hole that forms the entrance to the nasal cavity. The singular form of nare is naris (nare). The nostrils are separated by the nasal septum.

[0604] Nasolabial folds or nasolabial wrinkles: Folds or grooves of skin that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0605] Nasolabial angle: the angle between the columella and the upper lip (which intersect at the lower point of the nasal septum).

[0606] Auricular base: The lowest point where the auricle attaches to the facial skin.

[0607] Auricular base: The highest point where the auricle attaches to the facial skin.

[0608] Nasal prominence: The most prominent point or tip of the nose that can be identified in a side view of the rest of the head.

[0609] Philtrum: The midline groove that extends from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0610] Mental point: The midpoint of the frontmost part of the chin located on the soft tissue.

[0611] Ridge (nose): The nasal ridge is the midline protrusion of the nose extending from the nasal bridge point to the nasal protuberance point.

[0612] Sagittal plane: A vertical plane running from front (anterior) to back (posterior). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0613] Nasal point: The most concave point on the soft tissue covering the frontonasal suture area.

[0614] Septal Cartilage (Nose): The septal cartilage forms part of the nasal septum and divides the front of the nasal cavity.

[0615] Posterior superior lateral flap: The point at the inferior edge of the alar base where the alar base joins the skin of the upper (superior) lip.

[0616] Subnasal point: The point on the soft tissue where the columella meets the upper lip in the midsagittal plane.

[0617] Mandibular alveolar seat point: the point of maximum concavity on the midline of the lower lip between the midpoint of the lower lip and the premental point of the soft tissue

[0618] 5.8.4.2 Anatomy of the skull

[0619] Frontal Bone: The frontal bone includes a large vertical portion (the squama) that corresponds to an area called the pronasalis.

[0620] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0621] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye sockets. The frontal process of the maxilla projects upward from the sides of the nose and forms part of the lateral border.

[0622] Nasal Bones: The nasal bones are two small oval bones that vary in size and form in different individuals; they lie side by side in the middle and upper part of the face and form the "bridge" of the nose at their junction.

[0623] Nasal root: The intersection of the frontal bone and the two nasal bones, the concave area directly between the eyes and on the upper part of the bridge of the nose.

[0624] Occipital Bone: The occipital bone is located at the back and lower part of the skull. It contains an oval hole (foramen magnum) through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0625] Orbit: The bony cavity in the skull that holds the eyeball.

[0626] Parietal bones: The parietal bones are the bones that when joined together form the roof and sides of the skull.

[0627] Temporal Bones: The temporal bones are located at the base and sides of the skull and support the part of the face called the temples.

[0628] Zygomatic bones: The face includes two zygomatic bones, which are located on the upper and side parts of the face and form the prominence of the cheeks.

[0629] 5.8.4.3 Anatomy of the respiratory system

[0630] Diaphragm: A sheet of muscle that extends across the base of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0631] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0632] Lung: The respiratory organ of a person. The conducting zone of the lung contains the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone contains the respiratory bronchioles, alveolar ducts, and alveoli.

[0633] Nasal Cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called the nasal conchae (singular "concha") or turbinates. The front of the nasal cavity is the nose, while the back joins into the nasopharynx via the internal nostrils.

[0634] Pharynx: The part of the throat located just below (under) the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (epipharynx) (nasal portion of the pharynx), the oropharynx (mesopharynx) (oral portion of the pharynx), and the hypopharynx (hypopharynx).

[0635] 5.8.5 Patient interface

[0636] Anti-Asphyxia Valve (AAV): A component or subcomponent of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to atmosphere in a fail-safe manner.

[0637] An elbow is an example of a structure that directs the axis of an air flow traveling therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a cross-section that is approximately circular. In another form, the elbow may have an elliptical or rectangular cross-section. In certain forms, the elbow may be rotatable relative to a mating component, for example, approximately 360 degrees. In certain forms, the elbow may be removable from a mating component, for example, via a snap connection. In certain forms, the elbow may be assembled to a mating component via a one-time snap during manufacturing, but may not be removed by the patient.

[0638] Frame: A frame will be considered to mean the mask structure that carries the tensile load between two or more connection points to the headgear. A mask frame may be a non-airtight load-bearing structure in a mask. However, some forms of mask frames may also be airtight.

[0639] Headgear: A headgear will be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, a headgear may include a collection of one or more support bars, straps, and reinforcements configured to position and maintain a patient interface in position on the patient's face for delivery of respiratory therapy. Some straps are formed of soft, flexible, resilient materials, such as a laminate composite of foam and fabric.

[0640] Film: A film shall be taken to mean a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.

[0641] Plenum: A mask plenum will be taken to mean a portion of the patient interface having walls at least partially enclosing a volume of space which, in use, has air pressurized therein to above atmospheric pressure. The housing may form part of the wall of the mask plenum.

[0642] Seal: can be a noun form referring to a structure (seal) or a verb form referring to the effect (seal). Two elements can be constructed and / or arranged to 'seal' or achieve a 'seal' between them without the need for a separate 'seal' element itself.

[0643] Shell: Shell will be taken to mean a curved and relatively thin structure having bendable, stretchable and compressible stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0644] Reinforcement: A reinforcement will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0645] Braces: Braces will be considered to be structural components designed to increase the compression resistance of another component in at least one direction.

[0646] Swivel (noun): A subassembly of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be configured to rotate through an angular rotation of at least 360 degrees. In another form, the swivel may be configured to rotate through an angular rotation of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of the component preferably comprises a pair of matching cylindrical conduits. There may be little or no air flow leakage from the swivel when in use.

[0647] Tie (noun): A structure used to resist tension.

[0648] Vent (noun): A structure that allows air flow from the interior of a mask or duct to ambient air, e.g., for effective flushing of exhaled gases. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and the therapy pressure.

[0649] 5.8.6 Structure Shape

[0650] Products according to the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or a thruster. The three-dimensional structures may be combined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe the relative surface orientation, position, function, or some other feature. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a face-contacting (e.g., outer) surface and a separate non-face-contacting (e.g., underside or inner) surface. In another example, a structure may include a first surface and a second surface.

[0651] To help describe the shape of three-dimensional structures and surfaces, first consider a cross section through a point p on the surface of the structure, cf. FIG. 3B to FIG. 3F , which show a cross section at a point p on the surface and an example of the resulting plane curve. FIG. 3B to FIG. 3F Also shown is the outward normal vector at p, the outward normal vector at a point p far from the surface. In some examples, the surface is depicted from the point of view of an imaginary person standing upright on the surface.

[0652] 5.8.6.1 Curvature in one dimension

[0653] The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, the inverse of the radius of a circle that touches the curve only at p).

[0654] Positive curvature: If the curve at p turns toward the outward normal, then the curvature at that point will be positive (if the imaginary person were to leave that point p, they would have to walk uphill). Figure 3B (and Figure 3C Compared with the relatively large positive curvature) and Figure 3C (and Figure 3B Such curves are often called concave.

[0655] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if the imaginary person leaves point p, they can walk horizontally without going up or down). Figure 3D .

[0656] Negative curvature: If the curve at point p turns away from the outward normal, then the curvature in that direction at that point will be negative (if the imaginary person were to leave that point p, they would have to go downhill). Figure 3E (and Figure 3F Compared to the relatively small negative curvature) and Figure 3F (and Figure 3E Such curves are often called convex.

[0657] 5.8.6.2 Curvature of a Two-Dimensional Surface

[0658] A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. Multiple cross sections may cut the surface in a plane that includes the outward normal ("normal plane"), and each cross section may be taken in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at the point may have the same sign or different signs. Each curvature at the point has a magnitude, for example, a relatively small magnitude. FIG. 3B to FIG. 3F The plane curve in can be an example of such multiple cross sections at specific points.

[0659] Principal curvatures and principal directions: The directions of the normal planes where the curvature of the curve takes its maximum and minimum values ​​are called principal directions. FIG. 3B to FIG. 3F In the example of Figure 3B and the minimum value appears at Figure 3F Therefore Figure 3B and Figure 3F is the cross section in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0660] Region of a surface: A group of points on a surface. The points in a region can have similar characteristics, such as curvature or sign.

[0661] Saddle region: A region where at each point the principal curvatures have opposite signs, ie one sign is positive and the other sign is negative (depending on the direction the imagined individual is turning, they can be walking up or down).

[0662] Dome region: The region where at every point the principal curvatures have the same sign, e.g. two positive ("concave dome") or two negative ("convex dome").

[0663] Cylindrical region: A region where one of the principal curvatures is zero (or, for example, is zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0664] Planar Region: A surface region where both principal curvatures are zero (or are zero within manufacturing tolerances, for example).

[0665] Surface edge: The boundary or limit of a surface or area.

[0666] Path: In some forms of the present technology, 'path' will be taken to mean a path in the mathematical-topological sense, e.g., a continuous spatial curve from f(0) to f(1) on a surface. In some forms of the present technology, a 'path' may be described as a route or course comprising, e.g., a set of points on a surface. (An imagined individual's path is one in which they walk on a surface and is similar to a garden path).

[0667] Path length: In some forms of the present technology, 'path length' will be considered to be the distance along the surface from f(0) to f(1), i.e. the distance along a path on the surface. There may be more than one path between two points on the surface and such paths may have different path lengths. (The path length of an imaginary individual would be the distance they walked along the path on the surface).

[0668] Straight-line distance: Straight-line distance is the distance between two points on a surface, but regardless of the surface. In a planar region, there can be a path on the surface that has the same path length as the straight-line distance between two points on the surface. In a non-planar surface, there can be no path that has the same path length as the straight-line distance between two points. (For an imaginary individual, straight-line distance would correspond to the distance as a 'straight line'.)

[0669] 5.8.6.3 Space curve

[0670] Space curves: Unlike plane curves, space curves do not have to lie in any particular plane. Space curves can be closed, i.e., have no endpoints. Space curves can be thought of as one-dimensional segments of three-dimensional space. An imaginary person walking on one strand of a DNA helix walks along a space curve. A typical human left ear includes a helix, which is a left-handed helix, see Figure 3Q The typical human right ear includes a helix that is a right-handed helix, see Figure 3R . Figure 3 shows a right-handed spiral. The edge of a structure, for example, the edge of a membrane or an impeller, can follow a space curve. In general, a space curve can be described by the curvature and the twist at each point on the space curve. Torque is a measure of how the curve turns out of the plane. Torque has a sign and a magnitude. The twist at a point on a space curve can be characterized with reference to the tangent vector, normal vector, and binormal vector at that point.

[0671] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction from that point as well as the magnitude. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If an imaginary person were flying along the curve and fell from her aircraft at a particular point, the direction of the tangent vector is the direction she would be traveling.

[0672] Unit Normal Vector: This tangent vector itself changes as the imaginary person moves along the curve. The unit vector pointing in the direction of the change in the tangent vector is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0673] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P ) or alternatively by the left-hand rule ( Fig.3O ) to determine.

[0674] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. Fig.3O and 3P .

[0675] Torsion of a space curve: The torsion of a space curve at a point is the magnitude of the rate of change of the binormal unit vector at that point. It measures how much the curve deviates from the osculating plane. A space curve that lies within the plane has zero torsion. A space curve that deviates from the osculating plane by a relatively small amount will have a relatively small amount of torsion (e.g., a gently inclined spiral path). A space curve that deviates from the osculating plane by a relatively large amount will have a relatively large amount of torsion (e.g., a sharply inclined spiral path). See Figure 3S Since T2>T1, the twist near the top coil of the spiral in Figure 3 is greater than Figure 3S The amount of twist in the bottom coil of the helix.

[0676] Reference Figure 3P According to the right-hand rule, a space curve with a right-hand binormal can be considered to have a right-hand positive twist (e.g., Figure 3S A space curve that turns away from the right-handed binormal direction can be considered to have right-handed negative twist (e.g., a left-handed helix).

[0677] Similarly, refer to the left-hand rule (see Fig.3O ), a space curve oriented in the direction of the left-handed binormal can be considered to have a left-handed positive twist (e.g., a left-handed helix). Thus left-handed positive is equivalent to right-handed negative. See Figure 3T .

[0678] 5.8.6.4 Holes

[0679] A surface may have one-dimensional pores, for example, pores bounded by planar curves or by spatial curves. A thin structure (e.g., a membrane) having pores may be described as having one-dimensional pores. For example, see Fig. 3I A one-dimensional hole in a surface bounded by a planar curve for the structure shown.

[0680] A structure can have a two-dimensional hole, for example, a hole defined by a surface. For example, a pneumatic tire has a two-dimensional hole defined by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have a two-dimensional hole. For example, see Figure 3L The padding and the Figure 3M and Figure 3N , which shows an inner surface defining a two-dimensional hole. In yet another example, a conduit can include a one-dimensional hole (e.g., at its inlet or at its outlet) and a two-dimensional hole defined by the inner surface of the conduit. See also Figure 3K A two-dimensional hole in the shown structure bounded by the shown surface.

[0681] 5.9 Other notes

[0682] Unless the context clearly indicates and provides a numerical range, it is understood that each intervening value between the upper and lower limits of the range, to one-tenth of the unit of the lower limit, and any other stated or intervening value in the stated range are broadly included in the present technology. The upper and lower limits of these intermediate ranges may be independently included in the intermediate ranges and are also included in the present technology, but are subject to any explicitly excluded limits in the stated ranges. In the case where the stated range includes one or both of the stated limits, the present technology also includes ranges excluding either or both of those included limits.

[0683] Furthermore, where a value or values ​​are described herein for implementation as part of the present technology, it should be understood that such values ​​may be approximate unless otherwise indicated and that such values ​​may be used to any appropriate number of significant digits as permitted or required by practical technical implementation.

[0684] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the technology, a limited number of representative methods and materials are described herein.

[0685] When a specific material is identified for use in constructing a component, obvious alternative materials having similar properties are substituted therefor. In addition, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus may be manufactured together or separately.

[0686] It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural equivalents unless the context clearly dictates otherwise.

[0687] All publications mentioned herein are incorporated herein in their entirety by reference, to disclose and describe methods and / or materials as the subject of those publications. Providing the publications discussed herein is only for the disclosures before the filing date of the present application. Anything herein should not be construed as admitting that the present technology is not entitled to the priority of these publications due to previous inventions. In addition, the publication date provided may be different from the actual publication date, which may need to be confirmed separately.

[0688] The terms "comprises" and "comprising" should be understood to refer to each element, component or step in a non-exclusive manner, indicating that the marked elements, components or steps may be present or utilized, or in combination with other elements, components or steps that are not marked.

[0689] The subject headings used in the detailed description are for the convenience of the reader and should not be used to limit the subject matter that can be found in the disclosure or claims as a whole. The subject headings should not be used to interpret the scope of the claims or the limitations of the claims.

[0690] Although the present technology has been described herein with reference to specific embodiments, it should be understood that these embodiments only illustrate the principles and applications of the present technology. In some cases, terms and symbols may imply specific details that are not required for practicing the present technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order, but may be used to distinguish different elements. In addition, although the process steps in the method may be described or illustrated in a certain order, this order is not required. Those skilled in the art will recognize that this order may be modified, and / or aspects of the order may be performed simultaneously or even synchronously.

[0691] It is therefore to be understood that numerous modifications may be made to the exemplary embodiments described and that other arrangements may be devised without departing from the spirit and scope of the present technology.

[0692] 510 Reference Symbols List

[0693]

[0694]

[0695]

[0696]

Claims

1. A patient interface, comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber comprising a plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​a patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that a flow of air at the treatment pressure is delivered to at least the entrance to the patient's nares, the seal-forming structure constructed and arranged, in use, to maintain the treatment pressure in the plenum chamber throughout the patient's breathing cycle; a positioning and stabilizing structure providing a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a strap constructed and arranged so that, in use, at least a portion covers an area of ​​the patient's head above a supra-auricular base point of the patient's head; and a vent structure to permit continuous flow of gas exhaled by a patient from the interior of the plenum chamber to the surrounding environment, the vent structure being sized and shaped to maintain the therapeutic pressure in the plenum chamber during use; wherein the patient interface is configured to leave the patient's mouth uncovered during treatment, wherein the seal forming structure comprises two lateral support areas and a middle area, each of the lateral support areas is located at the outermost side of the seal forming structure, the middle area is located between the lateral support areas, the hole passes through the middle area, and Wherein, the lateral support area is thicker than the middle area.

2. A patient interface according to claim 1, wherein: The sealing forming structure further includes two intermediate lateral regions, each of which is laterally outward from the middle region and adjacent to the middle region and inward from the middle of the lateral support region and adjacent to the lateral support region, and the intermediate lateral region is thicker than the middle region and thinner than the lateral support region.

3. A patient interface according to claim 2, wherein: The seal-forming structure further includes two corner regions configured to engage the patient's face at the rear upper side panel region, the corner regions being located where the middle region, the middle lateral region, and the lateral support regions converge.

4. A patient interface according to any one of claims 1 to 3, wherein: The aperture is bridged to form two nostril openings, the bridge being relaxed in an undeformed state.

5. A patient interface according to claim 4, wherein: The bridge portion is thicker than the middle region.

6. A patient interface according to claim 4 or 5, wherein: The nostril opening is surrounded by the middle region and the bridge.

7. A patient interface according to any one of claims 1 to 6, wherein: The seal-forming structure is made of a flexible material.

8. A patient interface according to claim 7, wherein: The flexible material is silicone.

9. A patient interface according to any one of claims 1 to 8, wherein: The plenum chamber comprises an inner surface and an outer surface, and wherein the inner surface is arranged to be at the treatment pressure in use and the housing outer surface is arranged to be at ambient pressure in use.

10. A patient interface according to any one of claims 1 to 9, wherein: The plenum chamber is configured to be rigid when subjected to an internal pressure less than about 30 cmH2O above ambient pressure.

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