Inflation chamber insert for patient interface

Abstract

A patient interface comprising: an inflation chamber; sealing to form a structure; a positioning and stabilizing structure; a plenum chamber insert configured to be positioned and retained within the plenum chamber; a vent structure; wherein the plenum chamber insert has a plenum chamber insert port; wherein the plenum insert has an outer surface configured to be positioned adjacent an inner surface of the plenum; wherein when the plenum chamber insert is positioned and retained within the plenum chamber, a radial channel is formed by an inner surface of the plenum chamber and an outer surface of the plenum chamber insert such that gas can pass between a patient proximal side of the plenum chamber insert and a patient distal side of the plenum chamber insert via the radial channel during use.

Description

[0001] This application is a divisional application of the invention patent application with application number 202080012872.3, application date March 18, 2020, and invention name “Inflatable chamber insert for patient interface”. The invention patent application 202080012872.3 is an application entering the Chinese national phase of PCT international application PCT / IB2020 / 052459.

[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 patent file or records, but otherwise reserves all copyright rights whatsoever. 1 Cross-reference to related applications

[0004] This application claims the benefit of U.S. Provisional Application No. 62 / 820,098, filed on March 18, 2019, and U.S. Provisional Application No. 62 / 969,747, filed on February 4, 2020, the entire contents of each of which are incorporated herein by reference. 2 Background technology 2.1 Technical Field

[0005] 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.

[0006] 2.2 Description of Related Technology

[0007] 2.2.1 Human respiratory system and its disorders

[0008] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airway.

[0009] 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 called the respiratory zone. See "Respiratory Physiology", 9th edition, published by John B.West, Lippincott Williams & Wilkins in 2012.

[0010] There are a range of respiratory disorders. Some disorders can be characterised by specific events such as apnea, hypopnea and hyperpnea.

[0011] 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.

[0012] 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. This is caused by abnormally small upper airway in the area of ​​the tongue, soft palate and posterior oropharyngeal wall during sleep, plus normal loss of muscle tone. The disease causes affected patients to stop breathing, typically for a period of 30 to 120 seconds, sometimes 200 to 300 times per night. It often leads to excessive daytime sleepiness and may cause cardiovascular disease and brain damage. This complication is a common disorder, particularly in middle-aged overweight men, although the affected person may not be aware of this problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0013] 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 rise and fall 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 lead to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jonesrevert).

[0014] Respiratory failure is an umbrella term for breathing disorders in which the lungs cannot inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following disorders.

[0015] Patients with respiratory insufficiency, a form of respiratory failure, may experience abnormal shortness of breath during exercise.

[0016] 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.

[0017] Chronic obstructive pulmonary disease (COPD) includes 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.

[0018] Neuromuscular disease (NMD) is a broad term that covers many diseases and disorders 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 within a few 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.

[0019] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling 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 on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0020] A range of treatments have been used to treat or alleviate 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.

[0021] 2.2.2 Treatment

[0022] Various therapies have been used to treat one or more of the above-mentioned breathing disorders, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV).

[0023] 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 by CPAP therapy 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.

[0024] Non-invasive ventilation (NIV) provides ventilation support to the patient through the upper airway to help the patient 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.

[0025] 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.

[0026] 2.2.3 Treatment system

[0027] 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.

[0028] The therapy system may include a respiratory pressure therapy device (RPT device), air circuit, humidifier, patient interface, and data management.

[0029] Another form of treatment system is a mandibular repositioning device.

[0030] 2.2.3.1 Patient interface

[0031] 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 an area of ​​the patient's face, for example, to facilitate the delivery of gas at a pressure that is sufficiently different from the ambient pressure (e.g., a positive pressure of about 1010 cmH2O 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 about 10 cmH2O to the airway.

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

[0033] Certain masks may be clinically disadvantageous to the present technology, for example where they block air flow through the nose and only allow it through the mouth.

[0034] Certain masks may be uncomfortable or impractical for the present technology if they require the patient to insert a portion of the mask structure into their mouth to form and maintain a seal with their lips.

[0035] Some masks may not be feasible for use while sleeping (eg, while sleeping on one's side in bed with the head resting on a pillow).

[0036] 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.

[0037] 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. A mask of the wrong size 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 such masks are not as comfortable as ideal for long periods of time (e.g., several hours). This discomfort may lead to reduced patient compliance with treatment. This is even more true if the mask is worn during sleep.

[0038] 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 generally 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.

[0039] While a mask used for other applications (eg, pilots) may not be suitable for treating sleep-disordered breathing, a mask designed to treat sleep-disordered breathing may be suitable for other applications.

[0040] For these reasons, a diverse field of patient interfaces for delivering CPAP during sleep has emerged.

[0041] 2.2.3.1.1 Sealing structure

[0042] 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.

[0043] The patient interface can be characterized in part according to the design intent of the seal-forming structure to engage with the face during 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 to, for example, 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.

[0044] 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 of differences in shape, structure, variability, and sensitivity of the patient's facial areas. For example, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on the patient's nose.

[0045] 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.

[0046] One type of seal-forming structure extends around the periphery of the patient interface and is used 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.

[0047] Another type of seal-forming structure includes a sheet-like seal of thin material positioned around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous forms of seal-forming portions, 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.

[0048] Another type of seal-forming structure may include friction-fit elements, for example for insertion into a nostril, however some patients find these uncomfortable.

[0049] 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.

[0050] A series of patient interface seal forming structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0051] 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 US Patent No. 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Company.

[0052] 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 MIRAGELIBERTY TM Full face mask. The following patent application assigned to ResMed Ltd. describes an example of a nasal pillow mask: International Patent Application WO 2004 / 073778 (which describes the SWIFT TM Other aspects of nasal pillows); U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc. SWIFT 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).

[0053] 2.2.3.1.2 Positioning and stabilization

[0054] 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.

[0055] 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 make some people uncomfortable.

[0056] 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.

[0057] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0058] A respiratory pressure therapy (RPT) device may be used alone or as part of a system to deliver one or more of the various therapies described above, such as by operating the device to generate an air flow for delivery to an airway interface. The air flow may be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0059] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, such as 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.

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

[0061] Table of noise output levels of existing RPT devices (one sample only, measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744).

[0062] RPT device name A-weighted sound pressure level dB(A) Years (approximately) <![CDATA[C Series Tango TM > 31.9 2007 <![CDATA[C-Series Tango with Humidifier TM > 33.1 2007 <![CDATA[S8 Escape TM II]]> 30.5 2005 <![CDATA[With H4i TM S8 Escape 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

[0063] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a ventilator. A ventilator (such as the ResMed Stellar TM The company's range of adult and pediatric ventilators can provide support for invasive and non-invasive, independent ventilation for a range of patients to treat a variety of conditions, such as but not limited to NMD, OHS and COPD.

[0064] ResMed Elisée TM 150 ventilator and ResMed VS III TM Ventilators 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 motor-driven blower 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.

[0065] The designer of a device may have an infinite number of choices to make. 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.

[0066] 2.2.3.3 Humidifier

[0067] 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.

[0068] A range of artificial humidification devices and systems are known, but they may not meet the special requirements of medical humidifiers.

[0069] 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. Medical humidifiers can be constructed 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 may have stricter safety restrictions than industrial humidifiers.

[0070] 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.

[0071] 2.2.3.4 Data Management

[0072] Data may be obtained for clinical reasons to determine whether a patient prescribed a respiratory therapy is "compliant," such as that the patient has used their RPT device in accordance with one or more "compliance rules." An example of a compliance rule for CPAP therapy is that, in order to be considered compliant, a patient is required to use the RPT device for at least four hours per night for at least 21 out of 30 consecutive days. To determine a patient's compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing a patient's use of the RPT device for therapy, calculate usage over a predetermined time period, and compare it to the compliance rules. Once the healthcare provider has determined that a patient has used their RPT device in accordance with the compliance rules, the healthcare provider may inform third parties that the patient is compliant.

[0073] There are other parties to patient treatments that could benefit from sending treatment data to third parties or external systems.

[0074] Existing methods of sending and managing this type of data can be one or more of the following: expensive, time consuming, and error prone.

[0075] 2.2.3.5 Mandibular reduction

[0076] 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 (mandible) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes after sleep. Therefore, an MRD is not designed to be worn all the time. An MRD can be custom made or produced in a standardized form and includes a bite impression portion designed to allow fit 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 attenuates vibrations of the palate.

[0077] In some examples, the mandibular advancement device may include an upper splint for engaging or cooperating with teeth on the maxilla or maxilla and a lower splint for engaging or cooperating with teeth on the maxilla or mandible. The upper splint and the lower splint are connected together in the transverse direction by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper splint and the lower splint.

[0078] 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 is held in an anterior 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.

[0079] Some MRDs are constructed to push the mandible forward relative to the maxilla, while other MADs (such as the ResMed Narval CC TM The MRD) is designed to hold the mandible in a forward position. The device also reduces or minimizes side effects on the teeth and the temporomandibular joint (TMJ). Therefore, it is constructed to minimize or prevent any movement of one or more teeth.

[0080] 2.2.3.6 Ventilation technology

[0081] Some forms of therapy 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, such as to the environment.

[0082] 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 disrupt the sleep of the patient's 1000 bed partner 1100, for example by making noise or by gathering airflow.

[0083] ResMed Ltd. has developed many improved mask vent 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. 2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0084] Noise table of existing masks (ISO 17510-2:2007, pressure of 10cmH2O at 1m)

[0085]

[0086] (*One sample only, measured at 10cmH2O using the test method specified in ISO 3744 in CPAP mode) The sound pressure values ​​for various objects are listed below

[0087]

[0088] 2.2.3.7 Heat and Moisture Exchanger (HMX) Technology

[0089] Patients may be susceptible to drying of the internal airways when undergoing various forms of respiratory therapy as described elsewhere herein. For example, CPAP therapy requires continuous provision of a pressurized air flow at a pressure greater than ambient pressure to the patient, and this continuous air flow, particularly at elevated levels combined with positive air pressure, may result in drying of the patient's airways. This drying may cause discomfort, which in turn may negatively affect the patient's compliance with therapy.

[0090] In order to minimize the drying effect of these forms of respiratory therapy, the air flow provided to the patient can be humidified before it reaches the patient. Some forms of humidification technology actively provide moist air to the patient to reduce the drying effect by heating a reservoir of water and passing air over its surface to increase the absolute humidity of the air, that is, the air receives water vapor from the reservoir. The humidified air is then delivered to the patient via an air circuit. The air circuit can also be heated to prevent condensation of water vapor within the air circuit during transportation to the patient, also known as raining. These forms of technology typically involve filling a reservoir with water before treatment, and then providing the reservoir to the RPT system so that the water can be heated to humidify the air for treatment. The reservoir usually needs to be cleaned regularly, there is a risk of overflow, which can be particularly problematic in the case of electrical components, and the reservoir needs to be refilled by the patient before use.

[0091] No pre-supplied water source, such as a water-filled container, is required, and inputting electrical energy to heat the water can provide several benefits. For example, the RPT device can be made smaller because it will not require space for a water reservoir and a heating plate. Since no electrical energy is consumed when heating the water, electricity costs can be reduced. Moreover, fewer electrical components may be required in the RPT device, which reduces its cost and complexity. Moreover, the RPT device can be more easily used because there is no water reservoir to fill, empty, and clean. The risk of overflow can also be reduced. Moreover, the operation of the RPT device can be simplified because there is no humidification setting to operate.

[0092] In operation, a patient exhales (breathes out) air that has been heated within the patient and that has received water vapor from the patient's airway. Heat and moisture in the exhaled air are captured by the HMX material (S), i.e., the HMX material (S) is heated by the relatively warm exhaled air, and the HMX material (S) receives water vapor from the relatively humid exhaled air as the exhaled air passes through the HMX material (S) before being discharged to the atmosphere. During inhalation, a pressurized air stream passes through the HMX material in a direction opposite to the exhalation to reach the patient's airway, and the source of the incoming air is typically ambient air. Thus, as the pressurized air stream passes through the HMX material before reaching the patient's airway, the pressurized air stream receives moisture in the form of water vapor as it desorbs from the HMX material, and the pressurized air stream is heated by the heat released from the HMX material. 3. Summary of the invention

[0093] 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.

[0094]

[0013] One aspect of the present technology relates to devices for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0095] 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 further be configured so that the patient's mouth is not covered, or if the seal-forming structure is configured to seal around the patient's nose and mouth, the patient interface may further be configured to allow the patient to breathe from the surrounding environment in the absence of a pressurized air flow through the plenum inlet port.

[0096] Another aspect of the present technology relates to a patient interface, comprising: an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 4 cmH2O above ambient air pressure, the inflatable chamber including an inlet port of the inflatable chamber that is sized and structured to receive a flow of air at a therapeutic pressure for breathing by the patient; a seal-forming structure that is constructed and arranged to seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein so that the flow of air at the therapeutic pressure is delivered to at least one entrance to 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 that is Constructed to hold a seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure includes a strap constructed and arranged so that, in use, at least a portion covers an area of ​​the patient's head that is above the supra-auricular base of the patient's head; and a vent structure constructed to allow gas exhaled by the patient to flow continuously from the interior of the plenum chamber to the surrounding environment, the vent structure being sized and shaped to maintain a therapeutic pressure in the plenum chamber during use; wherein the patient interface is constructed so that the patient's mouth is not covered, or if the seal-forming structure is constructed to seal around the patient's nose and mouth, the patient interface is constructed to allow the patient to breathe from the surrounding environment in the absence of a pressurized air flow through the inlet port of the plenum chamber.

[0097] Another aspect of the present technology relates to a plenum chamber insert configured to be positioned and retained within a plenum chamber; wherein the plenum chamber insert has a plenum chamber insert port; wherein the plenum chamber insert has an outer surface configured to be positioned adjacent to an inner surface of the plenum chamber; wherein when the plenum chamber insert is positioned and retained within the plenum chamber, a radial passage is formed by the inner surface of the plenum chamber and the outer surface of the plenum chamber insert, allowing gas to pass between a patient-proximal side of the plenum chamber insert and a patient-distal side of the plenum chamber insert via the radial passage during use.

[0098] Another aspect of the present technology relates to a patient interface including a plenum chamber; a seal-forming structure; a positioning and stabilizing structure; a plenum chamber insert configured to be positioned and retained within a plenum chamber; and a vent structure; wherein the plenum chamber insert has a plenum chamber insert port; wherein the plenum chamber insert has an outer surface configured to be positioned adjacent to an inner surface of the plenum chamber; wherein when the plenum chamber insert is positioned and retained within the plenum chamber, a radial channel is formed by the inner surface of the plenum chamber and the outer surface of the plenum chamber insert, allowing gas to pass between a patient proximal side of the plenum chamber insert and a patient distal side of the plenum chamber insert via the radial channel during use.

[0099] Another aspect of the present technology relates to a patient interface comprising a plenum chamber; a seal-forming structure; a positioning and stabilizing structure; a plenum chamber insert constructed to be positioned and retained within the plenum chamber; a vent structure; wherein the plenum chamber insert has a plenum chamber insert port.

[0100] Aspects of the foregoing paragraphs may further include: (a) the plenum chamber insert having an outer surface configured to be positioned adjacent to an inner surface of the plenum chamber; and / or (b) when the plenum chamber insert is positioned and retained within the plenum chamber, a radial channel is formed by the inner surface of the plenum chamber and the outer surface of the plenum chamber insert, allowing gas to pass between a patient-proximal side of the plenum chamber insert and a patient-distal side of the plenum chamber insert via the radial channel during use.

[0101] Another aspect of the present technology relates to a patient interface comprising a plenum chamber pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber comprising a plenum chamber port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to contact and seal an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein such that the flow of air at the therapeutic pressure is delivered to at least one of the patient's nostrils; The invention relates to a device for providing a seal-forming structure for maintaining a therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use; a positioning and stabilizing structure, which is configured 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 configured and arranged so that at least a portion of the strap covers an area of ​​the patient's head that is above the patient's corresponding supra-ear base point during use; and an plenum chamber insert, which is configured to be positioned and retained in the plenum chamber and at the entrance of the patient's airway. between the opening and the plenum port; and a vent structure constructed to allow gas exhaled by the patient to flow continuously from the interior of the plenum to the surrounding environment, the size and shape of the vent structure being set to maintain a therapeutic pressure in the plenum during use; wherein the plenum insert has a plenum insert port, the plenum insert port being constructed to be positioned to be in pneumatic communication with the plenum port so that air flow at the therapeutic pressure passes through the plenum insert port after passing through the plenum port; wherein the plenum insert has a plenum insert port constructed to be adjacent an outer surface positioned proximate the inner surface of the plenum; wherein when the plenum insert is positioned and retained within the plenum, a radial passage is formed by the inner surface of the plenum and the outer surface of the plenum insert so that gas can pass between a patient proximal to the plenum insert and a patient distal to the plenum insert via the radial passage during use; and wherein the patient interface is constructed to allow the patient to breathe from the ambient environment through their mouth in the absence of pressurized air flow through the plenum inlet port, or the patient interface is constructed so that the patient's mouth is uncovered.

[0102] In examples of the aspects described in the preceding five paragraphs, (a) the seal-forming structure may be constructed and arranged to be positioned against the patient's face and around the patient's nostrils and mouth during use such that a flow of air at a therapeutic pressure is delivered through the aperture to the patient's nostrils and mouth, and the patient interface may be constructed to allow the patient to breathe a flow of pressurized air from the ambient environment through their mouth without a mouth; (b) the seal-forming structure and the plenum may have a generally triangular profile to cover the patient's nose and mouth while not covering the patient's eyes during use; and (c) the plenum insert may further include three radial channels positioned circumferentially around the plenum insert port and arranged to extend through the plenum insert port. and oriented to direct the seal-forming structure and the air inside the plenum from the patient's proximal side of the plenum insert to the patient's distal side of the plenum insert from the corresponding corner area of ​​the plenum insert port; (d) the plenum insert may further include a plurality of radial channels circumferentially positioned around the plenum insert port and oriented to direct the seal-forming structure and the air inside the plenum from the patient's proximal side of the plenum insert to the patient's distal side of the plenum insert; (e) the plenum insert may further include a heat and moisture exchanger (HMX) material constructed to receive and retain water from the patient's exhaled gas and to transfer the water to the patient's distal side. The retained water is desorbed into the air flow at the treatment pressure passing through the HMX material while providing the air flow at the treatment pressure to the plenum port, (f) the plenum insert can be permanently connected to the plenum; (g) the plenum insert can be removably connected to the plenum; (h) the plenum insert can further include an insert frame configured to secure the HMX material in an operable position within the plenum; (i) the insert frame can be permanently connected to the plenum; (j) the insert frame can be removably connected to the plenum; (k) the insert frame can further include a front insert frame and a rear insert frame configured to be attached to each other, and when the front insert frame and the The HMX material may be secured between the front insert frame and the rear insert frame when the rear insert frame is attached together; (1) the plenum insert port may be formed through the front frame; (m) the front insert frame may include a front insert frame wall, and the radial channels may be recessed into the front frame wall, or when the plenum insert also includes the three radial channels, the three radial channels may be recessed into the front frame wall, or when the plenum insert also includes the plurality of radial channels, the plurality of radial channels may be recessed into the front frame wall; (n) the rear insert frame may further include a plurality of rear insert frame openings such that at least a portion of the HMX material is exposed in a rearward direction facing the patient during use;(o) the rear insert frame may further include an orientation indicator configured to visually and / or tactilely indicate the orientation of the plenum chamber insert within the plenum chamber when the plenum chamber insert is assembled and when the plenum chamber insert is positioned and retained; (p) the front insert frame may further include at least one front insert frame gasket extending from the front insert frame wall, the front insert frame gasket configured to contact the HMX material and separate the HMX material from the front insert frame wall so that a gap is formed between the front insert frame wall and the HMX material; (q) at least one rear insert frame protrusion may extend from (r) the front insert frame may further include a catch or a pawl, and the rear insert frame may further include the other of the catch or the pawl, the catch and the pawl being configured to hold the front insert frame and the rear insert frame together; (s) the front insert frame may further include a plurality of catches or a plurality of catches, and the rear insert frame may further include the same number of corresponding catches and pawls; (t) the front insert frame may further include an edge, the The edge surrounds the insert frame port and extends in a forward direction thereof; (u) the front insert frame may also include an annular channel surrounding the edge and recessed into the front insert frame wall; (v) the frame assembly may be configured to connect to the inflatable chamber and connect the positioning and stabilizing structure to the inflatable chamber, and the edge may also include one or more tabs that releasably connect the inflatable chamber insert to the frame assembly through the inflatable chamber port; (w) the frame assembly may be configured to attach to the inflatable chamber and couple the positioning and stabilizing structure to the inflatable chamber, and the front insert frame may further include a one or more tabs to releasably connect the plenum insert to the frame assembly through the plenum port; (x) one or more annular passage vents may be formed through the front insert frame at the annular passage; (y) an elbow assembly may have a first end and a second end, the first end being configured to releasably attach to the frame assembly or the plenum and the second end being configured to releasably attach to an air circuit to provide an air flow at the treatment pressure to the plenum, the elbow assembly including the vent structure such that the vent structure is positioned relative to the plenum insert opposite to the patient's airway;(z) one or more radial channel vents may form channels radially through the front insert frame, or when the plenum insert further includes three radial channels, the front insert frame may include one or more radial channel vent channels formed through the front insert frame at one or more of the three radial channels, or when the plenum insert further includes a plurality of radial channels, the front insert frame may include one or more radial channel vent radial channels formed through the front insert frame at one or more of the plurality of channels; (aa) the plenum insert may be concave on the patient proximal side to avoid contact with the patient's face during use; (bb) the HMX material may include foam; (cc) the HMX material may include an open cell foam having a salt applied thereto; (dd) the HMX material may include paper; (ee) the HMX material may include a corrugated structure constructed from the paper that forms flow channels through the HMX material; (ff) the flow channels may be oriented to allow air to flow therethrough in a generally front-to-back direction during use; (gg) the HMX material may be shaped to generally correspond to the shape of the interior of the insert frame; (hh) the HMX material may be configured to deform into a shape that substantially corresponds to the interior of the insert frame; (ii) the HMX material may have a substantially uniform thickness, and / or (jj) the HMX material may have a thickness that varies in at least one direction.;

[0103] Another aspect of the present technology relates to a patient interface system comprising: a patient interface of any of the aspects and examples described in the preceding paragraphs; a respiratory pressure therapy device configured to pressurize an air flow at the therapy pressure; and an air circuit configured to direct the air flow from the respiratory pressure therapy device to the patient interface.

[0104] In further examples, the patient interface system may not include a humidifier, and the air circuit may include a tube having a heating element configured to heat the air flow, or the tube may not include a heating element.

[0105] Of course, parts of these aspects may form sub-aspects of the present technology. Sub-aspects and / or various aspects in an aspect may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

[0106] Other features of the present technology will be apparent by considering the following detailed description, abstract, drawings, and information contained in the claims. 4. Description of the drawings

[0107] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals indicate similar elements, including:

[0108] 4.1 Treatment system

[0109] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows and receiving a positive pressure supply of air from an 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.

[0110] 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 positive pressure supply of air from an 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.

[0111] 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 positive pressure supply of air from an 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.

[0112] 4.2 Respiratory system and facial anatomy

[0113] Figure 2A Shown is 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.

[0114] Figure 2B A view of the human upper airway including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, pharynx, tongue, epiglottis, vocal cords, esophagus, and trachea is shown.

[0115] Figure 2C is a front view of the face with several surface anatomical features identified, 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 indicated.

[0116] Figure 2D is a side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge point, nasal prominence point, subnasal septum point, upper lip, lower lip, supramental point, nasal bridge, nasal wing apex, supra-auricular base point, and subauricular base point. The superior-inferior and anterior-posterior directions are also labeled.

[0117] 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.

[0118] 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.

[0119] Figure 2G A side view of the nasal surface features is shown.

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

[0121] Fig.2I The medial anatomy of the nose is shown approximately several millimeters from the mid-sagittal plane, showing the medial crus of the septal cartilage and the greater alar cartilage.

[0122] 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.

[0123] Figure 2K A lateral view of the skull with the outline of the head surface and several muscles is shown. 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.

[0124] Figure 2L An anterolateral view of the nose is shown.

[0125] 3 Patient interface

[0126] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0127] 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.

[0128] 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.

[0129] Figure 3DA schematic diagram of a cross section through a structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0130] 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.

[0131] 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.

[0132] 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.

[0133] Figure 3H A 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.

[0134] Fig. 3I A surface of a structure is shown, wherein the surface has a one-dimensional hole in it. The plane curves shown form the boundaries of the one-dimensional hole.

[0135] 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.

[0136] 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.

[0137] Figure 3L A mask with an inflatable bladder as a cushion is shown.

[0138] Figure 3M Shown through Figure 3L A cross-section of a mask of FIG. 1 and showing the inner surface of the bladder. The inner surface defines a two-dimensional hole in the mask.

[0139] Figure 3N Shown through Figure 3L Another cross section of a mask of FIG. The inner surface is also shown.

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

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

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

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

[0144] Figure 3S A right-hand helix is ​​shown.

[0145] Figure 3T A view of a mask is shown including the sign of the twist of the spatial curve defined by the edge of the sealing membrane in different regions of the mask.

[0146] Figure 3U A view of the plenum chamber 3200 is shown, showing the sagittal plane and the medial contact plane.

[0147] 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.

[0148] 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 cushion 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 cushion in this area, the middle contact plane may be a tangent at the upper and lower points.

[0149] 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.

[0150] 4.4RPT device

[0151] Figure 4A One form of RPT device according to the present technology is shown.

[0152] 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.

[0153] Figure 4C is a schematic diagram of the electrical components of an RPT device according to one form of the present technology.

[0154] 4.5 Humidifier

[0155] Figure 5A Shown is an isometric view of a humidifier in accordance with one form of the present technology.

[0156] 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.

[0157] Figure 5C A schematic diagram of a humidifier according to one form of the present technology is shown.

[0158] 4.6 Respiratory waveform

[0159] Figure 6 A model typical breathing waveform of a sleeping person is shown.

[0160] 4.7 Patient Interface of the Technology

[0161] Figure 7 is a perspective view showing a patient interface on a patient's head according to an example of the present technology.

[0162] Figure 8 yes Figure 7 Side view of the patient interface shown.

[0163] Fig. 9 is a perspective view of a patient interface according to an example of the present technology, the patient interface being shown with a headgear removed.

[0164] Fig.10 yes Fig. 9 A perspective view of the patient interface is shown with the arm cover for the upper arm of the frame assembly removed.

[0165] Fig.11 yes Fig.10 Front view of the patient interface shown.

[0166] Fig.12 yes Fig.10 Rear view of the patient interface shown.

[0167] Fig.13 yes Fig.10 Side view of the patient interface shown.

[0168] Fig.14 yes Fig. 9 An exploded view of the patient interface shown illustrating the cushion assembly, frame assembly, arm caps, and elbow assembly.

[0169] Fig.15 yes Fig.10 An exploded view of a patient interface shown in FIG. 1 shows the cushion assembly and frame assembly removably connected with the elbow assembly removed.

[0170] Fig.16 yes Fig.10 An exploded view of a patient interface shown in FIG. 1 , showing a frame assembly and an elbow assembly removably connected with a removed cushion assembly.

[0171] Fig.17 is a perspective view of multiple components of a patient interface assembled together according to an example of the present technology.

[0172] Fig.18 is a front view of components of a patient interface assembled together according to an example of the present technology.

[0173] Fig.19 is a rear view of multiple components of a patient interface assembled together according to an example of the present technology, including a plenum insert.

[0174] Fig. 20 is a lateral view of components of a patient interface assembled together according to an example of the present technology.

[0175] Fig.21 It passes through Fig. 20 A cross-sectional view of components of a patient interface taken along line 21-21, including a plenum insert assembled together according to an example of the present technology.

[0176] Fig. 22 It passes through Fig.18 22 - 22 of a cross-sectional view of components of a patient interface including a plenum insert assembled together according to an example of the present technology.

[0177] Fig.23 yes Fig. 22 A cross-sectional view of the system against the patient's face.

[0178] Fig.24 is an exploded view of a seal-forming structure, chassis, plenum insert, frame assembly, and elbow assembly according to an example of the present technology.

[0179] Fig.25 is a front view of a seal-forming structure, chassis, and plenum insert according to an example of the present technology.

[0180] Fig.26 is a top view of a seal-forming structure, chassis, and plenum insert according to an example of the present technology.

[0181] Fig. 27 is a lateral view of a seal-forming structure, chassis, and plenum insert according to an example of the present technology.

[0182] Fig.28 is a through-hole according to an example of the present technology Fig.26 A cross-sectional view of the seal-forming structure, chassis and plenum insert taken along line 28-28.

[0183] Fig.29 is a through-hole according to an example of the present technology Fig. 27 A cross-sectional view of the seal-forming structure, chassis and plenum insert taken along line 29-29.

[0184] Fig.30 is a front perspective view of a plenum insert according to an example of the present technology.

[0185] Fig.31 is a rear perspective view of a plenum insert according to an example of the present technology.

[0186] Fig.32 is a front view of a plenum insert according to an example of the present technology.

[0187] Fig.33 is a rear perspective view of a plenum insert according to an example of the present technology.

[0188] Fig.34 is a lateral view of a plenum insert according to an example of the present technology.

[0189] Fig.35 is an example according to the present technology along Fig.34 A cross-sectional view of the plenum insert taken along line 35-35.

[0190] Fig.36 is an example according to the present technology along Fig.32 A cross-sectional view of the plenum insert taken along line 36-36.

[0191] Fig.37is a front perspective view of a rear insert frame of a plenum insert according to an example of the present technology.

[0192] Fig.38 is a rear perspective view of a rear insert frame of a plenum insert according to an example of the present technology.

[0193] Fig.39 is a front perspective view of a front insert frame of a plenum insert according to an example of the present technology.

[0194] Fig.40 is a rear perspective view of a front insert frame of a plenum insert according to an example of the present technology.

[0195] Fig.41 is a front view of a front insert frame of a plenum insert according to an example of the present technology.

[0196] Fig.42 is a rear view of a front insert frame of a plenum insert according to an example of the present technology.

[0197] Fig.43 is a lateral view of a front insert frame of a plenum insert according to an example of the present technology.

[0198] Fig.44 is an example of the present technology. Fig.41 A cross-sectional view of the front insert frame of the plenum insert taken along line 44-44.

[0199] Fig.45 is an example of the present technology. Fig.43 A cross-sectional view of the front insert frame of the plenum insert taken along line 45-45.

[0200] Fig.46 is a front perspective view of a heat and moisture exchanger (HMX) material of a plenum insert according to an example of the present technology.

[0201] Fig.47 is a rear perspective view of a heat and moisture exchanger (HMX) material of a plenum insert according to an example of the present technology.

[0202] Fig.48 is a front perspective view of a seal-forming structure, chassis, frame assembly, and elbow assembly according to an example of the present technology.

[0203] Fig.49 is a front view of a seal-forming structure, chassis, frame assembly, and elbow assembly according to an example of the present technology.

[0204] Fig.50 is a rear perspective view of a seal-forming structure, chassis, and plenum insert according to an example of the present technology.

[0205] Fig.51 is a lateral view of a seal-forming structure, chassis, frame assembly, and elbow assembly according to an example of the present technology.

[0206] Fig.52 is a through-hole according to an example of the present technology Fig.51 A cross-sectional view of the seal forming structure, chassis, frame assembly, elbow assembly and inflation chamber insert taken along line 52-52.

[0207] Fig.53 is a through-hole according to an example of the present technology Fig.49 A cross-sectional view of the seal forming structure, chassis, frame assembly, elbow assembly and inflation chamber insert taken along line 53-53.

[0208] Fig.54 yes Fig.53 A cross-sectional view of the system against the patient's face.

[0209] Fig.55 is an exploded view of a seal-forming structure, chassis, plenum insert, frame assembly, and elbow assembly according to an example of the present technology.

[0210] Fig.56 is a front view of a seal-forming structure, chassis, and plenum insert according to an example of the present technology.

[0211] Fig.57 is an upper view of a seal-forming structure and chassis according to an example of the present technology.

[0212] Fig.58 is a lateral view of a seal-forming structure and chassis according to an example of the present technology.

[0213] Fig.59 is a through-hole according to an example of the present technology Fig.57 A cross-sectional view of the seal-forming structure, chassis and plenum insert taken along line 59-59.

[0214] Fig.60 is a through-hole according to an example of the present technology Fig.58 A cross-sectional view of the seal-forming structure, chassis and plenum insert taken along line 60-60.

[0215] Fig.61 is a front perspective view of a plenum insert according to an example of the present technology.

[0216] Fig.62 is a rear perspective view of a plenum insert according to an example of the present technology.

[0217] Fig.63 is a rear perspective view of a plenum insert according to an example of the present technology.

[0218] Fig.64 is a front view of a plenum insert according to an example of the present technology.

[0219] Fig.65 is a lateral view of a plenum insert according to an example of the present technology.

[0220] Fig.66 is an example according to the present technology along Fig.65 A cross-sectional view of the plenum insert taken along line 66-66.

[0221] Fig.67 is an example according to the present technology along Fig.64 A cross-sectional view of the plenum insert taken along line 67-67.

[0222] Fig.68 is a front perspective view of a front insert frame of a plenum insert according to an example of the present technology.

[0223] Fig.69 is a rear perspective view of a front insert frame of a plenum insert according to an example of the present technology.

[0224] Fig.70 is a front view of a front insert frame of a plenum insert according to an example of the present technology.

[0225] Fig.71 is a rear view of a front insert frame of a plenum insert according to an example of the present technology.

[0226] Fig.72 is a lateral view of a front insert frame of a plenum insert according to an example of the present technology.

[0227] Fig.73 is an example of the present technology. Fig.72 A cross-sectional view of the front insert frame of the plenum insert taken along line 73-73.

[0228] Fig.74 is an example of the present technology. Fig.70 A cross-sectional view of the front insert frame of the plenum insert taken along line 74-74.

[0229] Fig.75 An example based on the present technology is shown. Fig.53 Cross-sectional view of a patient interface comprising a plenum insert that rests against the patient's face during an inhalation phase.

[0230] Fig.76 Shows Fig.75 Detailed view of the .

[0231] Fig.77 A front view of a plenum insert during an inhalation phase is shown in accordance with an example of the present technology.

[0232] Fig.78 A front view of a plenum chamber insert during apnea is shown in accordance with an example of the present technology.

[0233] Fig.79 An example of the present technology is shown in which a Fig.78 A cross-sectional view of the plenum insert taken along line 79-79.

[0234] Fig.80 An example based on the present technology is shown. Fig.53 Cross-sectional view of a patient interface comprising a plenum insert that rests against the patient's face during an exhalation phase.

[0235] Fig.81 Shows Fig.80 Detailed view of the .

[0236] Fig.82 A front view of a plenum insert during an exhalation phase is shown in accordance with an example of the present technology.

[0237] Fig.83 shows a flow chart of ... during the exhalation phase according to an example of the present technology. Fig.82 A cross-sectional view of the plenum insert taken along line 83-83.

[0238] Fig.84 An example based on the present technology is shown. Fig. 22 Cross-sectional view of a patient interface comprising a plenum insert that rests against the patient's face during an inhalation phase.

[0239] Fig.85 Shows Fig.84 Detailed view of the .

[0240] Fig.86 A front view of a plenum insert during an inhalation phase is shown in accordance with an example of the present technology.

[0241] Fig.87 A front view of a plenum chamber insert during apnea is shown in accordance with an example of the present technology.

[0242] Fig.88 An example of the present technology is shown in which a Fig.87 A cross-sectional view of the plenum insert taken along line 88-88.

[0243] Fig.89 An example based on the present technology is shown. Fig. 22Cross-sectional view of a patient interface comprising a plenum insert that rests against the patient's face during an exhalation phase.

[0244] Fig.90 Shows Fig.89 Detailed view of the .

[0245] Fig.91 A front view of a plenum insert during an exhalation phase is shown in accordance with an example of the present technology.

[0246] Fig.92 shows a flow chart of ... during the exhalation phase according to an example of the present technology. Fig.91 A cross-sectional view of the plenum insert taken along line 92-92.

[0247] Fig.93 is a perspective view of a patient interface 3000 according to an example of the present technology as worn by a patient.

[0248] Fig.94 is a perspective view of a patient interface 3000 according to an example of the present technology.

[0249] Fig.95 is a rear view of a patient interface 3000 according to an example of the present technology.

[0250] Fig.96 is a perspective view of a seal-forming structure 3100 and a plenum chamber 3200 according to an example of the present technology.

[0251] Fig.97 is a front view of a seal-forming structure 3100 and a plenum chamber 3200 according to an example of the present technology.

[0252] Fig.98 is a rear perspective view of a seal-forming structure 3100 and a plenum chamber 3200 according to an example of the present technology.

[0253] Fig.99 is a perspective view of a patient interface 3000 according to another example of the present technology.

[0254] Fig.100 is a front view of a seal-forming structure 3100 and a plenum chamber 3200 according to an example of the present technology.

[0255] Fig.101 is a rear perspective view of a seal-forming structure 3100 and a plenum chamber 3200 according to an example of the present technology.

[0256] Fig.102 is a front side view of an example of the present technology worn by a patient, viewed from an upper position of the patient interface.

[0257] Fig.103is a front-side view viewed from an upper position of a patient interface according to an example of the present technology.

[0258] Fig.104 is a rear view of a patient interface according to an example of the present technology.

[0259] Fig.105 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.

[0260] Fig.106 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.

[0261] Fig.107 is a lateral view viewed from an upper position of a patient interface according to an example of the present technology worn by a patient.

[0262] Fig.108 is a rear view of a patient interface according to an example of the present technology.

[0263] Fig.109 is a front perspective view of a plenum insert according to an example of the present technology.

[0264] Fig.110 is a rear perspective view of a plenum insert according to an example of the present technology.

[0265] Fig.111 is a front view of a plenum insert according to an example of the present technology.

[0266] Fig.112 is a rear perspective view of a plenum insert according to an example of the present technology.

[0267] Fig.113 is a lateral view of a plenum insert according to an example of the present technology.

[0268] Fig.114 It passes through Fig.111 A cross-sectional view of a plenum insert according to an example of the present technology is shown along line 114-114.

[0269] Fig.115 It passes through Fig.111 A cross-sectional view of a plenum insert according to an example of the present technology taken along line 115-115.

[0270] Fig.116 is a front perspective view of a rear insert frame of a plenum insert according to an example of the present technology.

[0271] Fig.117 is a rear perspective view of a rear insert frame of a plenum insert according to an example of the present technology.

[0272] Fig.118 is a front perspective view of a front insert frame of a plenum insert according to an example of the present technology.

[0273] Fig.119 is a rear perspective view of a front insert frame of a plenum insert according to an example of the present technology.

[0274] Fig.120 is a front view of a front insert frame of a plenum insert according to an example of the present technology.

[0275] Fig.121 is a rear view of a front insert frame of a plenum insert according to an example of the present technology.

[0276] Fig.122 is a lateral view of a front insert frame of a plenum insert according to an example of the present technology.

[0277] Fig.123 is through Fig.120 A cross-sectional view of a front insert frame of a plenum insert according to an example of the present technology, taken along line 123-123.

[0278] Fig.124 is through Fig.120 A cross-sectional view of a front insert frame of a plenum insert according to an example of the present technology, taken along line 124-124.

[0279] Fig.125 is a front perspective view of a heat and moisture exchanger (HMX) material of a plenum insert according to an example of the present technology.

[0280] Fig.126 is a rear perspective view of a heat and moisture exchanger (HMX) material of a plenum insert according to an example of the present technology.

[0281] Fig.127 is a front view of a plenum insert according to an example of the present technology.

[0282] Fig.128 is a rear view of a plenum insert according to an example of the present technology.

[0283] Fig.129 is a front perspective view of a heat and moisture exchanger (HMX) material of a plenum insert according to an example of the present technology.

[0284] Fig.130 is a rear perspective view of a heat and moisture exchanger (HMX) material of a plenum insert according to an example of the present technology.

[0285] Figures 131-138 A rear view of a rear insert frame of a plenum insert having an orientation indicator is shown according to an example of the present technology.

[0286] Fig.139 A rear view of a plenum insert having an orientation indicator and heat and moisture exchanger (HMX) material is shown in accordance with an example of the present technology.

[0287] Fig.140 A side view of an example of a heat and moisture exchanger (HMX) material is shown.

[0288] Fig.141 A top perspective view of an example of a heat and moisture exchanger (HMX) material is shown.

[0289] Fig.142 A bottom perspective view of an example of a heat and moisture exchanger (HMX) material is shown.

[0290] Fig.143 Shown is a top view of a large sheet of heat and moisture exchanger (HMX) material according to an example of the present technology. 5. Specific implementation methods

[0291] Before further describing the technology of the present invention in detail, it should be understood that the technology of the present invention is not limited to the specific examples described herein, and the specific examples described herein may be changed. It should also be understood that the terms used in this disclosure are only for the purpose of describing the specific examples described herein and are not intended to be limiting.

[0292] 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 of the examples, any single feature or combination of features may constitute another example.

[0293] 5.1 Treatment

[0294] 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 entrance to the airway of a patient 1000 .

[0295] In certain examples of the present technology, a positive pressure supply of air is provided to the patient's nasal passages via one or both nostrils.

[0296] In some examples of the present technology, mouth breathing is limited, restricted, or prevented.

[0297] 5.2 Treatment system

[0298] 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 to a patient interface 3000 .

[0299] 5.3 Patient Interface

[0300] 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. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway to facilitate the supply of positive pressure air to the airway.

[0301] If the patient interface is unable to comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0302] 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.

[0303] 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.

[0304] 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.

[0305] Figure 7-16 A patient interface that may be provided with an inflatable chamber insert according to an example of the present technology is shown. A description of the present patient interface follows, and further details are provided in U.S. Patent Application Publication No. US2018 / 0250486 A1, which is incorporated herein by reference in its entirety. The patient interface includes a frame assembly 6100, a chassis 6175 including a seal-forming structure 6200, an air delivery connector (e.g., an elbow assembly 6600), and a positioning and stabilizing structure (e.g., a headband 6800, including an upper side strap 6802, a lower side strap 6804, and a top strap 6806). Figures 7 to 9 is an exemplary view of a patient interface 6000 in which an arm cover 6750 is used to attach an upper arm 6134 of a frame assembly 6100, and Figures 10 to 16 is an exemplary view of the patient interface 6000 with the headband 6800 and arm covers 6750 removed.

[0306] Similar to the above example, the chassis 6175 is connected to the frame assembly 6100 (via a first retention feature on the frame assembly) independently of the elbow assembly 6600, while the elbow assembly 6600 is connected to the frame assembly 6100 (via a second retention feature on the frame assembly) independently of the bumper assembly 6175. That is, the retention connections of the chassis 6175 and the elbow assembly 6600 to the frame assembly 6100 are separate and distinct from each other and allow for independent engagement / disengagement.

[0307] In the example of the patient interface 6000, a first seal for the airflow path is formed between the elbow assembly 6600 and the frame assembly 6100, and a separate second seal is formed between the frame assembly 6100 and the cushion assembly 6175. In this example, the frame assembly 6100 is disposed in the airflow path. That is, the elbow assembly 6600 is configured to establish a hard-to-hard connection and a dynamic seal with the frame assembly 6100, and the chassis 6175 is configured to establish a separate hard-to-hard connection and a static seal with the frame assembly 6100.

[0308] In this example, the first end portion 6610 includes a plurality of vents 6700 to allow exhaust gases to vent from the patient interface.

[0309] Additionally, in the example of the patient interface 6000, the frame assembly 6100 includes a locking feature along the opening 6105 that is constructed and arranged to prevent direct connection or insertion of the air circuit 4170 (e.g., an air delivery tube). This arrangement requires the use of an elbow assembly 6600 to interconnect the frame assembly 6100 with the air circuit 4170, thereby ensuring that the elbow assembly 6600 (and its ventilation and anti-asphyxia valve (AAV valve)) is present in the system.

[0310] In one example, the frame assembly 6100 includes a shield or wall member 6110, a pair of (i.e., left and right) upper headband connector arms 6134 (each including two flexible portions 6140, 6145) extending from respective sides of an upper portion of the shield 6110, and a pair of (i.e., right and left) lower headband connector arms 6154 extending from respective sides of a lower portion of the shield 6110.

[0311] In the illustrated example, each upper headband connector arm 6134 includes an upper headband connection point in the form of a slot 6135 that is configured to receive a corresponding upper headband strap 6802 of the headband.

[0312] In the example shown, the central flexible portion 6140 of each arm 6134 includes a single slot 6141 (on the back side) that forms a hinge. In the example shown, the peripheral flexible portion 6145 of each arm 6134 includes multiple slots 6146 (on each side of the arm, i.e., slots on the front and / or back side of the arm) that form multiple hinges on the cheek area.

[0313] In one example, the peripheral flexible portion 6145 of each arm need not include slots on the front or back sides. Alternatively or additionally, the flexible portion may include one or more interconnected elastomeric (e.g., silicone) segments that may form a flush or smooth transition between relatively stiff plastic segments but allow flexing, bending, and / or pivoting. These may be manufactured by insert or overmolding, where the stiffer plastic segments are placed in the mold and the interconnected segments are molded over the stiffer plastic segments.

[0314] Each lower headband connector arm 6154 includes a magnetic connector 6155 (including an encapsulated magnet 6155B) that is configured to be positioned and connected to a headband clip 6160 provided to a corresponding lower headband strap of the headband. In the illustrated example, the end of each lower arm 6154 includes a magnet receiving portion 6155A for receiving and aligning the magnet 6155B and a cap 6155C for enclosing and retaining the magnet 6155B to the magnet receiving portion 6155A. As shown, the magnetic connector 6155 provides a protrusion that allows the magnetic connector 6155 to be inserted and retained in a corresponding receptacle provided by the headband clip 6160.

[0315] In one example, the upper arm 6134 and / or the lower arm 6154 may be covered with fabric, e.g., for aesthetics, to increase the soft / comfortable feel, to provide comfort on the face and to minimize markings. For example, a fabric arm cover or sock 6750 is provided on the upper arm 6134, while the arm cover 6750 is removed. The cover 6750 hides the upper arm 6134 so that the outer surface is smooth to increase comfort on the face, e.g., without markings and easier to slide over the facial surface. The cover 6750 may optionally be removable.

[0316] In one example, at least a portion of the upper arm 6134 and / or the lower arm 16154 can include a dimple or gold ball pattern, for example, for aesthetic purposes.

[0317] In one example, the elbow assembly 6600 includes a first end portion 6610 having a clamping arm 6650 for releasably engaging with the frame assembly 6100 and a second end portion 6620 adapted to be connected to the air circuit 4170 , for example via a swivel connector 6625 .

[0318] Additionally, the elbow assembly 6600 is configured to accommodate an AAV assembly including an AAV configured to allow the patient to breathe through the port if an insufficient amount of pressurized gas is being delivered or not being delivered.

[0319] 5.3.1 Sealing structure

[0320] 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 - may vary from day to day during a given treatment period and from patient to patient, depending on a number 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.

[0321] In one form, the target seal-forming area is located on an outer surface of the seal-forming structure 3100 .

[0322] In some forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material such as silicone rubber.

[0323] The seal-forming structure 3100 according to the present technology can be constructed of a soft, flexible and elastic material such as silicone.

[0324] In some forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure 3100 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.

[0325] 5.3.1.1 Sealing mechanism

[0326] 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 inside the inflatable chamber 3200 acting on its bottom side, so that it forms a tight sealing engagement with the face. The pressure assist mechanism can work together with the elastic tension in the positioning and stabilizing structure.

[0327] 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, such as 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 marginal edge of the plenum 3200 and extends around at least a portion of the path of the periphery. The support flange is or includes a spring-like element and acts to support the sealing flange to prevent it from bending during use.

[0328] In one form, the seal forming structure may comprise a compression seal or a gasket seal. In use, the compression seal or gasket seal is constructed and arranged to be in a compressed state, for example due to elastic tension in the positioning and stabilising structure.

[0329] 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.

[0330] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0331] 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.

[0332] 5.3.1.2 Nose bridge or nasal ridge area

[0333] 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.

[0334] 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 a patient's face in use.

[0335] 5.3.1.3 Upper lip area

[0336] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal on the upper lip region (ie, upper lip) of the patient's face.

[0337] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on an upper lip region of a patient's face in use.

[0338] 5.3.1.4 Chin area

[0339] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that, in use, forms a seal over the chin region of the patient's face.

[0340] In one form, the seal-forming structure comprises a saddle-shaped region configured to form a seal on a chin region of a patient's face in use.

[0341] 5.3.1.5 Forehead area

[0342] 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.

[0343] 5.3.1.6 Nasal pillows

[0344] 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.

[0345] 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 side of a patient's nose; a stem; and a flexible region located on the bottom side 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 accommodate 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.

[0346] 5.3.2 Inflatable chamber

[0347] In the area where the seal is formed in use, the plenum 3200 has a periphery that is shaped to complement the surface contour of an average human face. In use, the marginal 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 periphery 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.

[0348] In some forms of the present technology, the inflatable chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the inflatable chamber. Such a form is less obtrusive and / or more comfortable for the wearer, which can improve compliance with treatment.

[0349] 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 functions.

[0350] In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.

[0351] 5.3.3 Positioning and stabilizing the structure

[0352] The seal-forming structure 3100 of a patient interface 3000 of the present technology may be maintained in a sealed position by a positioning and stabilising structure 3300 during use.

[0353] In one form, the positioning and stabilising structure 3300 provides a retaining force that is at least sufficient to overcome the lifting effect of the positive pressure in the plenum 3200 off the face.

[0354] In one form, the positioning and stabilising structure 3300 provides a retaining force to overcome the effects of gravity on the patient interface 3000 .

[0355] In one form, the positioning and stabilising structure 3300 provides a retaining force as a safety margin to overcome the potential effects of disturbance forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0356] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured 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.

[0357] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is constructed so as not to be so large and bulky that a patient cannot lie flat in a supine position with the back region of the patient's head resting on a pillow.

[0358] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is constructed so as not to be so large and bulky that a patient cannot lie flat in a side-lying position with the side area of ​​the patient's head resting on a pillow.

[0359] In one form of the present technology, the positioning and stabilising structure 3300 is provided with a decoupling portion located 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 strap 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.

[0360] 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.

[0361] In some forms of the present technology, the positioning and stabilizing structure 3300 includes an extendable, e.g., elastically extendable, strap. For example, the strap may be configured to be in a tensioned state 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 may be configured as a tie.

[0362] 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.

[0363] 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 second strap that is constructed and arranged so that, in use, at least a portion of its upper edge passes below the subauricular base of the patient's head and covers or is located below the occipital bone of the patient's head.

[0364] 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 that is 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.

[0365] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a flexible and, for example, non-rigid strap. An advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0366] In some forms of the present technology, the positioning and stabilizing structure 3300 includes a strap that is configured to be breathable to allow moisture vapor to be transmitted through the strap.

[0367] 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 3300 being 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 fits a large sized head but not a small sized head, and another that fits a small sized head but not a large sized head.

[0368] 5.3.4 Ventilation

[0369] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide.

[0370] 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 when the pressure within the plenum chamber is positive relative to the surrounding environment. The vent 3400 is configured so that in use the amount of ventilation flow is sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining a therapeutic pressure in the plenum chamber.

[0371] One form of a vent 3400 in accordance with the present technology includes a plurality of holes, for example, from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0372] The vent 3400 may be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure such as a swivel.

[0373] 5.3.5 Decoupling structure

[0374] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or ball and socket.

[0375] 5.3.6 Connection Port

[0376] The connection port 3600 allows connection to the air circuit 4170 .

[0377] 5.3.7 Forehead support

[0378] In one form, the patient interface 3000 includes a forehead support 3700. In other forms, the patient interface 3000 may not include a forehead support.

[0379] 5.3.8 Anti-suffocation valve

[0380] In one form, the patient interface 3000 includes an anti-asphyxia valve. The anti-asphyxia valve 6605 may be located within the elbow 6600.

[0381] 5.3.9 Ports

[0382] 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.

[0383] 5.3.10 Inner mask HMX and plenum insert

[0384] The present technology contemplates providing water vapor to the air flow before the air reaches the patient's airway, without including a pre-filled water reservoir in the overall RPT system. Water vapor from ambient air and / or the patient's exhaled breath can instead be collected / captured and then supplied back to the patient in the form of humidified air with increased absolute humidity. The water vapor content from one or both of these sources can be sufficient to keep the patient's airway sufficiently moist to avoid or minimize patient discomfort.

[0385] The present technology contemplates the use of a heat and moisture exchange (HMX) component to provide humidity to the air supplied to the patient. Thus, the treatment system may operate without a humidifier 5000, for example, a reservoir of water that is heated to humidify the air after passing through the RPT device 4000. Additionally, since the HMX material is located within the patient interface, i.e., downstream of the incoming pressurized air flow via the air circuit, it may not be necessary to include a heating tube in the air circuit, as the air traveling through the air circuit will not have its humidity increased by the humidifier, which in turn increases the chance of rain (condensation within the air circuit), or if a heating tube is included, it may be left on during use. In the alternative, a heated tube may be included in the treatment system and operated during treatment, as heating the incoming pressurized air flow may allow it to receive more water as it passes through the HMX material.

[0386] HMX material may be placed within the air passage, and it is advantageous to place the HMX material as close to the patient as possible to ensure that the HMX material acquires or captures the maximum amount of moisture to be re-supplied to the patient's breathing air. However, including HMX within the air path may cause increased impedance to ventilation flow, which may reduce the flushing of carbon dioxide to the atmosphere. Therefore, the present technology also contemplates one or more passages that allow the exhaled gas flow to bypass the high impedance of the HMX material.

[0387] Figure 17-47 Components associated with examples of the present technology are depicted that provide relatively high performance levels (i.e., sufficiently high humidity) and can also provide a level of impedance to the incoming pressurized air flow that allows it to be used with a wider range of available RPT devices, such as those capable of higher therapeutic pressures and flow rates (e.g., ResMed's AirSense10).

[0388] Figure 17-24 Subassemblies of a patient interface according to an example of the present technology are shown. The depicted components include a seal-forming structure 6200, a plenum insert 3800, a plenum or chassis 6175, a frame assembly 6100, and an elbow assembly 6600.

[0389] Figure 25-29A further subassembly is shown which includes a seal-forming structure 6200, a plenum or chassis 6175, and a plenum insert 3800.

[0390] Figure 30-36 Another subassembly is shown that includes components of a plenum insert 3800 , a front insert frame 3804 , a rear insert frame 3802 , and a heat and moisture exchanger (HMX) material 3806 . Fig.37 and 38 The rear insert frame 3802 is shown, Figures 46-47 HMX material 3806 is shown, which is the same in both the low impedance version and the high humidification version of the plenum insert 3800. Figure 39-45 The front insert frame 3804 is shown in greater detail.

[0391] Figure 48-74 Components associated with examples of the present technology are depicted that can provide a level of impedance to the incoming pressurized air flow that may be optimal for use with more compact and easily travelable RPT devices that may be battery powered and may not be capable of as high therapeutic pressures and flow rates, such as ResMed's AirMini. As will be explained, when the pressure and / or flow rate of the incoming pressurized air 2000 is low, the baffle 3803 can help the flow of the incoming pressurized air 2000 (which may be at a relatively low pressure and / or flow rate due to the capabilities of the RPT device) spread over the HMX material 3806 to enhance humidification performance.

[0392] Figure 48-55 Subassemblies of a patient interface according to an example of the present technology are shown. The depicted components include a seal-forming structure 6200, a plenum insert 3800, a plenum or chassis 6175, a frame assembly 6100, and an elbow assembly 6600.

[0393] Figure 56-60 A further subassembly is shown which includes a seal-forming structure 6200, a plenum or chassis 6175, and a plenum insert 3800.

[0394] Figures 61-67 Another subassembly is shown that includes components of a plenum insert 3800 , a front insert frame 3804 , a rear insert frame 3802 , and a heat and moisture exchanger (HMX) material 3806 . Figures 68-74 The front insert frame 3804 is shown in greater detail.

[0395] Fig.37 and Fig.38 The rear insert frame 3802 is shown, Figures 46-47HMX material 3806 is shown, which is the same in both the low impedance version and the high humidification version of the plenum insert 3800.

[0396] 5.3.10.1 HMX materials

[0397] The HMX material 3806 captures, retains, and distributes heat and moisture. Different HMX materials 3806 can be used, such as foams, cellulose-based materials such as paper or textiles, or combinations of two or more such materials. The HMX material 3806 in paper form can be a corrugated structure that forms multiple channels that allow air to travel along these channels through the HMX material. The HMX material 3806 can also be treated with a hygroscopic substance such as one or more salts, which can enhance the ability of the HMX material 3806 to receive water vapor. Depending on the conditions in the plenum insert 3800 (e.g., humidity and temperature), moisture can be absorbed and / or adsorbed by the HMX material 3806, and moisture can also condense on the HMX material 3806.

[0398] In an example of the present technology, the HMX material 3806 is a flexible polyurethane foam that has been treated with calcium chloride. The purpose of using this material is to capture and release water vapor to provide humidity. The base foam (flexible, polyurethane) can be a reticulated (such as a net) open-cell foam. This material can be easily cut and shaped so that it can fit into the inflatable chamber insert 3800, as will be described below. The open-cell foam material can also be used as a base to hold salt because it has a relatively large surface area compared to its volume. The open-cell foam material may also be advantageous because of its low aerodynamic impedance (i.e., low airflow resistance) and low weight.

[0399] Calcium chloride is an example of a salt that can be used in the present technology, but other salts are possible. Calcium chloride may be suitable because it strongly adsorbs moisture (water vapor) from the air, causing the salt crystals on the foam surface to swell. This hygroscopic property of the salt makes it suitable for performing the function of capturing (adsorbing) the patient's moisture from the air during exhalation and returning (desorbing) it to the incoming air flow during inhalation. This function can balance the humidity of the mask volume by absorbing moisture during high humidity periods and releasing moisture during low humidity periods.

[0400] Figures 139-143HMX material 3806 is shown in the form of a corrugated paper. The corrugated paper may include a base layer 3870, a corrugated layer 3872, a plurality of joints 3874 connecting the base layer 3870 to the corrugated layer 3872, and grooves 3876 formed when the base layer 3870 and the corrugated layer 3872 are separated to allow air to flow therethrough. Thus, when the corrugated HMX material 3806 is installed in the plenum insert 3800, the corrugated HMX material 3806 can be oriented so that the grooves 3876 are generally parallel to the air flow through the plenum insert 3800. This can increase the surface area available for heat and moisture exchange between the HMX material 3806 and the air passing through it. The HMX material 3806 can be rolled into a roll, such as Fig.139 Alternatively, HMX material 3806 can be formed by vertically stacking corrugated paper layers (e.g., as described in U.S. Patent Application Publication No. US 2016 / 0175552A1, the entire contents of which are incorporated herein by reference).

[0401] Fig.143 Also shown are profiles of HMX material strips 3806 cut at different angles relative to the corrugated layer 3872. This allows for different angled paths through the grooves 3876 to be formed when the HMX material 3806 is assembled, for example, into a roll.

[0402] 5.3.10.2 Frame and positioning in the plenum

[0403] The patient interface 6000 of the present technology may use a plenum insert 3800 to hold the HMX material 3806 in place within the plenum 6175 so that inlet and outlet airflow may pass through the HMX material 3806 for moisture adsorption and desorption. Since the HMX material 3806 may be constructed of one or more of the materials discussed above, which may be relatively lightweight and may not be relatively rigid, the plenum insert 3800 may help the HMX material 3806 maintain its shape within the plenum 6175 and remain in place during treatment.

[0404] In one example, the plenum insert 3800 is a frame for the HMX material 3806. The plenum insert 3800 may include a rear insert frame 3802 and a front insert frame 3804 that may be releasably coupled together and may releasably hold the HMX material 3806 therebetween. The front insert frame 3804 may be molded, for example, in one piece, from a relatively rigid plastic material (e.g., polycarbonate). The rear insert frame 3802 may be molded, for example, in one piece, from a relatively flexible plastic material (e.g., polypropylene).

[0405] As in Fig.23and Fig.54 As can be seen in the cross-sectional view of, for example, when the plenum insert 3800 is inserted into the patient interface 6000 and the patient interface 6000 is worn by the patient 1000, the plenum insert 3800 will be positioned between the entrance of the patient's 1000 airway and the plenum port 6176. The plenum insert 3800 can be inserted into the patient interface 6000, specifically the plenum 6175, and retained therein. The plenum insert 3800 can divide the plenum 6175 into a front and rear region, with the rear region being adjacent to the patient during use. The plenum insert 3800 can also be positioned sufficiently within the plenum 6175 in a forward direction to avoid contact with the patient's face when the patient interface 6000 is worn by the patient. Moreover, due to being positioned within the plenum 6175, when the patient interface 6000 is worn by the patient, the plenum insert 3800 can be located sufficiently close to the entrance of the patient's airway to allow as much humidified, warmed air as possible from the plenum insert 3800 to reach the patient's airway, and to allow as much humidified, warmed air as possible from the patient's airway to reach the plenum insert 3800. Therefore, the components of the plenum insert 3800, rear insert frame 3802, front insert frame 3804, and HMX material 3806 can have a concave shape on their rear sides to avoid contact with the patient's face.

[0406] The plenum insert 3800 may be releasably attached to the plenum 6175 by attaching to the plenum 6175 or to another component. For example, the front insert frame 3804 may include a plurality of tabs 3814 that are clipped to the frame assembly 6100, such as by snap fit, through the plenum port 6176 and into the port or opening 6105 of the frame assembly 6100. The frame assembly 6100 may include a retaining structure 6190 that extends into the port 6105 (e.g., such as Fig.12 ), the port receives the tabs 3814. The retaining structure 6190 can be constructed as a single piece with the frame assembly 6100. The retaining structure 6190 can extend radially inward from the opening 6105.

[0407] Figure 21-2352-54 show examples of how the plenum insert 3800 is connected to the frame assembly 6100 via tabs 3814 on the front insert frame 3804 that are connected to the retaining structure 6190. In the former example, the tabs 3814 are formed on the edge 3812, which will be described in further detail below, and the tabs 3814 can extend radially outward from the edge 3812. The former example also includes three tabs 3814 formed on the edge 3812, but it should be understood that the tabs 3814 can be sufficient to connect to the retaining structure 6190, and in other examples, two tabs 3814 can be formed on the edge 3812, and in other examples, more than three tabs 3814 can be formed on the edge 3812. The latter example includes four tabs 3814 extending from the annular channel 3816 formed on the front insert frame 3804, and the tabs 3814 can extend parallel to the edge 3812, but separated from the edge 3812. It should be understood that in the latter example, the tab 3814 may be sufficient to connect to the retaining structure 6190, and in other examples, two, three, or more than four tabs 3814 may also be formed on the edge 3812. Figure 52-54 ), the tabs 3814 extend through corresponding retaining structure holes 6192 formed through the retaining structure 6190. Thus, there can be a number of tabs 3814 corresponding to the number of retaining structure holes 6192.

[0408] Alternatively, the plenum insert 3800 may be coupled to one or more structures formed on the inner surface 6180 of the plenum 6175 .

[0409] The plenum insert 3800 may also include a plenum insert port 3811 that receives the pressurized air flow 2000 from the RPT device 4000 via the air circuit 4170 and the elbow assembly 6600. Cross Section Figure 21-23 52-54 show that, when assembled, the plenum port 6176, the opening 6105 in the frame assembly 6100, and the plenum insert port 3811 can be arranged to be in substantially coaxial pneumatic communication (e.g., coaxially) because these components are also in line with the first end portion 6610 of the elbow assembly 6600 connected to the frame assembly 6100 at the opening 6105. As described above, this arrangement allows the pressurized air flow 2000 to pass through the plenum insert 3800 to be heated and humidified during treatment.

[0410] Figure 21-23The cross sections of 52-54 also illustrate how the outer surfaces of the plenum insert 3800, such as the outer surfaces of the front insert frame 3804 (e.g., the front insert frame wall 3822), can be positioned adjacent to the inner surface 6180 of the plenum 6175 to minimize the amount of air that can bypass it when the HMX material 3806 enters the plenum 6175. For example, the front insert frame wall 3822 and the inner surface 6180 of the plenum 6175 can be in contact at least at some points, or the front insert frame wall 3822 can be in full contact with the inner surface 6180 of the plenum 6175 so that air cannot pass between these surfaces. Alternatively, these surfaces may not be in contact, but rather may be very close together so that the resistance to airflow is very high so that there is only negligible flow between these surfaces.

[0411] The front insert frame 3804 may also include an edge 3812 that may be positioned adjacent to or in contact with an inner wall 6614 of the first end portion 6610 of the elbow assembly 6600 such that the incoming air flow 2000 passes from the elbow assembly 6600 and directly into the plenum insert 3800, as in Figure 21-23 For example, edge 3812 can have an outer diameter that is smaller than the inner diameter of inner wall 6614, such that edge 3812 extends into the hole formed by inner wall 6614 and edge 3812 and inner wall 6614 overlap, as shown in FIG. Figure 52-54 . The opposite arrangement is also possible. In either arrangement, the elbow assembly 6600 can rotate freely about its connection with the frame assembly 6100 at the lip 6106 without destroying the connection between the inflation chamber insert 3800 and the frame assembly 6100 at the retaining structure 6190.

[0412] Figure 21-23 6100 without interfering with the connection between the plenum insert 3800 and the frame assembly 6100 at the retention structure 6190.

[0413] It should also be understood that Figure 21-23 The elbow assembly 6600 shown and Figure 52-54 The elbow assembly 6600 shown is compatible with the arrangement of the edge 3812 and the tab 3814 in the previous example. However, Figure 21-23 The elbow assembly 6600 shown in FIG. Figure 52-54The arrangement of the edge 3812 and tab 3814 of the example shown in is incompatible because the edge 3812 is longer to engage the inner wall 6614 and therefore the deflection structure 6615 will contact the edge 3812 and move the inflatable chamber insert 3800 out of its connection with the frame assembly 6100.

[0414] In both configurations, the elbow assembly 6600 may also include an outer wall 6612 that, together with the inner wall 6614, forms an elbow ventilation flow path 6616 to allow ventilation flow through the elbow 2001 to reach the vent 6700 without being interfered with by the flow of incoming pressurized air 2000. Thus, the inner wall 6614 may be understood to separate the incoming air flow from the outgoing air flow, which prevents the incoming pressurized air 2000 from being discharged directly into the atmosphere and prevents the outgoing ventilation flow through the elbow 2001 from being recirculated back to the patient.

[0415] As described above, the arrangement of the edge 3812 in pneumatic communication with the elbow assembly 6600 can help maximize the amount of air that passes through the plenum insert 3800 and, therefore, the HMX material 3806 as the air travels from the elbow assembly 6600 to the patient's airway to maximize humidification. By ensuring that as much of the incoming air flow as possible passes through the HMX material 3806 during use, heat and moisture exchange performance can be optimized. However, it should be understood that, as will be described below, a certain amount of flow that bypasses the HMX material 3806 can also be advantageous to ensure that the HMX material 3806 is not dried by the air that reaches the HMX material 3806, receives moisture, and then is discharged directly to the surrounding environment without reaching the patient 1000.

[0416] In addition to the concave shape of the rear side of the plenum insert 3800 facing the patient, the rear insert frame 3802 can prevent the patient's skin from contacting the HMX material 3806 in addition to helping to keep the HMX material 3806 within the plenum insert 3800. The rear insert frame 3802 can have a generally open structure, i.e., include several rear insert frame openings 3842. Many rear insert frame openings 3842 provide a large exposed surface area on the patient's proximal side of the HMX material 3806 for exhaled air to reach the HMX material 3806 so that it can receive moisture and heat. Depending on the conditions (e.g., humidity and temperature) in the plenum insert 3800, moisture can be absorbed and / or adsorbed by the HMX material 3806, and moisture can also condense on the HMX material 3806. Similarly, the large exposed surface area of ​​the HMX material 3806 , the HMX material rear surface 3830 on the patient proximal side, allows pressurized air flow through the HMX material 3806 and into the plenum 6175 with minimal impedance from the rear insert frame 3802 .

[0417] The rear insert frame 3802 may also include an orientation indicator 3836 to provide a visual and / or tactile indication of the orientation of the plenum insert 3800. For example, Fig.38 The orientation indicator 3836 is shown to be shaped like a droplet, with the pointed portion indicating the upper side and the rounded portion indicating the lower side. Since the plenum insert 3800, and in particular the front insert frame 3804, is shaped to fit tightly onto the inner surface of the plenum 6175, and the generally triangular shape of the plenum 6175 is asymmetric in at least one direction, the plenum insert 3800 can be shaped so that it fits onto the inner surface of the plenum 6175 in only one orientation. Thus, the orientation indicator 3836 can help the patient determine the proper orientation of the plenum insert 3800 for assembly.

[0418] Figures 131-139 An example of an orientation indicator 3836 that can be formed on the rear insert frame 3802 is shown. In these examples, the rear insert frame 3802 can be formed integrally with the orientation indicator 3836 (e.g., molded). Alternatively, the rear insert frame 3802 and the orientation indicator 3836 can be formed separately (e.g., molded) and then fixed to each other. The contour of the shape of the orientation indicator 3836 can be a solid material and can be open in addition to allow air to pass through the opening formed by the orientation indicator 3836. The orientation indicator 3836 can indicate the correct orientation of the plenum insert 3800 entering the patient interface 3000 for the patient-when observed as shown in these figures, the vertical orientation of the image formed by the orientation indicator 3836 can indicate to the patient that the plenum insert 3800 is correctly oriented to be assembled to the patient interface 3000. In addition, because the orientation indicator 3836 can be formed by a solid material, a visually impaired patient can determine the appropriate orientation by touching the orientation indicator 3836 to determine the orientation of the plenum insert 3800. Additionally, when the plenum insert 3800 has a circular shape, these orientation indicators 3836 may assist the patient in determining the correct orientation when installing the plenum insert 3800 in the patient interface 3000 .

[0419] Fig.131 A directional indicator 3836 is shown in the form of a crescent moon and clouds. Fig.132 An orientation indicator 3836 in the form of a heart is shown. Fig.133 A directional indicator 3836 is shown in the form of a water drop and a wavy arrow indicating upward evaporation. Fig.134 The orientation indicator 3836 is shown in the form of text (numbers and / or letters in any language may be used). Fig.135 An orientation indicator 3836 is shown in the form of a single water drop. Fig.136 An orientation indicator 3836 is shown in outline form for a full-face patient interface (see Fig.25 ). Fig.137 An orientation indicator 3836 is shown in the form of a flower having a stem and leaves. Fig.138 A directional indicator 3836 is shown in the form of a wave on the surface of the water and water droplets. Fig.139 Shows Fig.135 orientation indicator 3836 and HMX material 3806 in the form of corrugated paper rolled into a roll.

[0420] Fig.139 Also shown are a pair of tabs 3837 positioned relative to each other on the rear insert frame 3802. The tabs 3837 can improve patient usability by providing a gripping surface for installing and removing the plenum insert 3800 from the patient interface 3000 when assembled. These tabs 3837 can also serve as orientation indicators 3836. In addition, in other examples, there can be only one tab 3837 at the top or bottom of the rear insert frame 3802.

[0421] As described above, the rear inserter frame 3802 may also retain the HMX material 3806 within the plenum insert 3800 by securing the HMX material 3806 against the front inserter frame 3804. The rear inserter frame 3802 may include one or more rear inserter frame tabs 3834 to engage the HMX material rear surface 3830 of the HMX material 3806 and push the HMX material front surface 3828 against the front inserter frame pad 3824 on the patient-proximal side of the front inserter frame 3804. In addition, to ensure that the front inserter frame 3804 and the rear inserter frame 3802 remain connected to retain the HMX material 3806, the front inserter frame 3804 and the rear inserter frame 3802 may include one or more pairs of corresponding detents 3808 and pawls 3832. Additionally, HMX material 3806 may have notches 3826 corresponding to each of a pair of detents 3808 and pawls 3832 such that HMX material 3806 does not interfere with engagement between detents 3808 and pawls 3832 while extending as far as possible to the periphery of plenum insert 3800 .

[0422] As described above, the HMX material 3806 can be urged against the front insert frame gasket 3824 to hold the HMX material 3806 in place within the plenum insert 3800. The front insert frame gasket 3824 can also separate the HMX material 3806 from the front insert frame inner surface 3823 to form a void 3825 within the plenum insert 3800. The front insert frame gasket 3824 and the void 3825 they form within the plenum insert 3800 can allow the incoming pressurized air flow 2000 to diffuse across the front surface 3828 of the HMX material 3806 to ensure that as much of the incoming flow as possible is heated and humidified by the HMX material 3806. Additionally, incoming pressurized air flow 2000 entering plenum insert 3800 via port 3811 may be concentrated in the immediate vicinity of HMX material 3806, while peripheral areas of HMX material 3806 will receive less flow, which in turn may produce suboptimal performance in terms of heat and moisture exchange.

[0423] exist Figure 48-82 In the example shown, the front insert frame 3804 may also include a baffle 3803 extending from the edge 3812 into the port 3811, while other versions shown in the previous figures may not include the baffle 3803. The baffle 3803 may also help diffuse and distribute the incoming pressurized air flow 2000 from the port 3811 to be as uniform as possible across the front surface 3828 of the HMX material 3806. The baffle 3803 may include baffle holes 3807 that allow the incoming pressurized air flow 2000 to pass therethrough. In addition, the baffle 3803 may be positioned within the port 3811 by a baffle suspension tab 3805 that forms a baffle bypass path 3809 to allow the incoming pressurized air flow 2000 to bypass the baffle and edge 3812 to spread across the HMX material 3806.

[0424] Figure 109-126 and Figures 127-130Shown is a further example of a plenum insert 3800 according to the present technology. In these examples, the plenum insert 3800 includes a rear insert frame 3802, a front insert frame 3804 and an HMX material 3806, which is positioned between the rear insert frame 3802 and the front insert frame 3804 and is held in place by the rear insert frame 3802 and the front insert frame 3804. In one example, the rear insert frame 3802, the front insert frame 3804 and the HMX material 3806 have a generally circular shape around their respective peripheries. The shape and size of these parts of the plenum insert 3800 can be selected based on the shape and size of the plenum 3200 of the patient interface 3000, and the plenum insert 3800 is intended to be used with the patient interface 3000. Therefore, the plenum insert 3800 can be designed to cooperate with a specific patient interface 3000, but not with other patient interfaces. Additionally, the circular shape of the plenum insert 3800 may allow the plenum insert 3800 to be attached to the patient interface 3800 regardless of orientation.

[0425] The plenum inserts 3800 of these examples may also include a peripheral gap 3844 between the periphery of the HMX material 3806 and the inner periphery of the rear insert frame 3802 and the front insert frame 3804. The front insert frame 3804 may also include a plurality of peripheral gaskets 3846 that are spaced circumferentially around the inner and outer peripheries of the front insert frame 3804 so as to maintain the peripheral gap 3844 when the HMX material 3806 is installed. The peripheral gap 3844 may allow the incoming pressurized gas flow to pass around the periphery of the HMX material 3806 so that it may spread across the front surface of the HMX material 3806 (i.e., away from the patient and toward the direction of the incoming flow). Allowing the incoming pressurized air flow to be more evenly spread on the front surface of the HMX material 3806 may improve heat and moisture exchange by ensuring that the incoming pressurized air flow is not concentrated on any particular area of ​​the HMX material 3806 and is more evenly dispersed on the HMX material 3806.

[0426] The rear insert frame 3802 may also include a rear HMX retainer 3848 that is shaped and sized to be concave so as to retain the HMX material 3806 in a concave shape away from the patient's face during use. Fig.125 and Fig.126The HMX material 3806 is shown to be shaped to have a concave side 3856 and a convex side 3858. The concave side 3856 can face the patient during use and this shape helps avoid contact between the patient's facial features and the HMX material 3806, which may contaminate the HMX material 3806 and / or cause discomfort to the patient. The rear insert frame 3802 can also include a tab 3852 that engages a corresponding notch 3854 in the front insert frame 3804 to indicate the correct orientation of the front insert frame 3804 and the rear insert frame 3802 relative to each other when the plenum insert 3800 is assembled.

[0427] The front insert frame 3804 may also include a front HMX retainer 3850 to retain the HMX material 3806 , prevent the HMX material 3806 from protruding through the plenum insert port 3811 , and prevent foreign objects from contacting the HMX material 3806 through the plenum insert port 3811 .

[0428] exist Figures 127-130 In the example of the HMX material 3806, the HMX material 3806 includes HMX material pores 3860. The HMX material pores 3860 can allow more flow through the HMX material 3806 to reduce impedance while still maintaining sufficient heat and moisture exchange during use. The HMX material 3806, whether formed of paper or foam, can include HMX material pores 3860.

[0429] 5.3.10.3 Ventilation and carbon dioxide flushing

[0430] While the plenum insert 3800 and HMX material 3806 can provide humidification during treatment, these structures can also impede flow through the plenum 6175. As described above, forming the HMX material 3806 from open cell foam or corrugated paper can minimize the impedance of the incoming pressurized air flow directed through the HMX material. However, the plenum insert 3800 can also impede the outflow of the exhaled air stream containing a relatively high concentration of carbon dioxide. As described above, minimizing the rebreathing of carbon dioxide is advantageous and improves treatment. Therefore, the plenum insert 3800 includes the following features to improve the discharge of exhaled air.

[0431] The front insert frame 3804 may include one or more radial channels 3810. The depicted example shows Figure 30-45 and Figures 61-74There are three radial channels 3810 in the version of the plenum insert 3800 shown, but one radial channel 3810 may be sufficient, depending on its location, size, and configuration of the patient interface. In these examples, the plenum insert 3800 is designed for a patient interface having a generally triangular shape, and each radial channel 3810 corresponds generally to one corner of the triangle, because these corner areas may include higher concentrations of carbon dioxide due to stagnant flow in these areas. The described examples show the plenum insert 3800 used with a compact full-face patient interface, i.e., a patient interface that does not cover the patient's eyes, but rather surrounds the nose and mouth for delivering a pressurized air flow to the patient's airway. Thus, the patient interface may have a generally triangular shape in that it is wide enough to span the patient's mouth at the lower portion, but not so wide at the upper portion that it would interfere with the patient's eyes. While this shape may adequately cover and seal around the entrance to the patient's airway, the corners of the triangular shape may create dead space, which is an area where the circulation and mixing of the exhaled air and pressurized air flow is not optimal. As a result, exhaled gases, particularly carbon dioxide, may be trapped and accumulate in these areas rather than being exhausted to the atmosphere, which may leave excess carbon dioxide within the patient interface for rebreathing by the patient.

[0432] Thus, radial channels 3810 may provide a pathway for exhaled air to collect in these corner regions to more easily pass to the vent and escape from the patient interface to the surrounding environment.

[0433] The radial channels 3810 may be recessed from adjacent portions of the front insert frame wall 3822 at three locations roughly corresponding to the three corner regions of the roughly triangular shaped patient interface. These radial channels 3810 may provide a flow path for exhaled air (e.g., carbon dioxide) to bypass the plenum insert 3800 and the HMX material 3806 to reach the vent structure 3400 (e.g., the vent 6700 in the elbow assembly 6600) for venting to the atmosphere. Thus, when the plenum insert 3800 is inserted into the plenum 6175 and adjacent to the inner surface 6180 of the plenum 6175, the inner surface 6180 of the plenum 6175, the front insert frame wall 3822, and the radial channels 3810 recessed from the front insert frame wall 3822 may form a bypass channel 2010 for allowing the bypass flow 2003 of the exhaled air to more easily reach the vent 6700. By targeting the corner areas of the patient interface with this configuration of radial channels 3810, flow impedance can be reduced, which allows the incoming pressurized air flow to circulate with the exhaled air and force the exhaled air out to reduce the carbon dioxide available for rebreathing within the patient interface.

[0434] The plenum insert 3800 and the radial passages 3810 can be sized to provide an exhaled air bypass function for similar patient interfaces of different sizes within a given configuration (e.g., a compact full face). Thus, the arrangement can be provided for any patient interface configuration described further below.

[0435] The front insert frame 3804 may also include an annular channel 3816 radially outward of the edge 3812. The annular channel 3816 may also be recessed from the front insert frame wall 3822 so that the retaining structure 6190 of the frame assembly 6100 may extend into the annular channel 3816 and allow the tab 3814 to be attached to the retaining structure 6190 on the frame assembly 6100.

[0436] Additionally, the front insert frame 3804 may include a plurality of radial channel vents 3820 and annular channel vents 3818. These vents may improve the flow of air into and out of the interior of the plenum insert 3800. The radial channel vents 3820 and annular channel vents 3818 may allow a portion of the flow of incoming pressurized air 2000, whose flow is blocked by the HMX material 3806, to change direction and pass through the atmosphere without being humidified and warmed by the HMX material 3806. This arrangement may reduce the amount of heat and moisture lost to the atmosphere by ensuring that excess incoming pressurized air flow 2000 may more easily pass directly to the atmosphere and not have the opportunity to cool and dry the HMX material 3806 without benefiting the patient.

[0437] It has been described above that radial channels 3810 can help vent carbon dioxide from dead space areas within a patient interface where flow circulation may be restricted. This is particularly advantageous when the plenum insert 3800 is used for heat and moisture exchange, because the plenum insert 3800 can increase the impedance to the outflow flow of exhaled gas and the inflow flow of pressurized air. However, it should be understood that radial channels 3810 can improve carbon dioxide washout regardless of the presence of HMX material 3806, because radial channels 3806 can provide a path for exhaled gas (such as carbon dioxide) that can accumulate in dead space areas that exist due to the shape and configuration of the patient interface, without necessarily being the result of ventilation flow impedance caused by HMX material 3806. Therefore, it should be understood that a plenum insert 3800 with radial channels 3810 but without HMX material 3806 can be incorporated into a patient interface when the functionality of HMX material 3806 may not be needed.

[0438] 5.3.10.4 RPT device compatibility and patient interface configuration

[0439] Different arrangements of the plenum insert 3800, i.e., with and without baffles 3803, can provide better overall performance for differently configured therapeutic systems, such as different types of RPT devices. In addition, it should be understood that the features of the plenum insert 3800 described herein can be used with a wide range of patient interface configurations, including those described in the following subsections. For example, the shape and size of the plenum insert 3800, the presence or absence of baffles 3803, the number, shape and size of the radial channels 3810, and any other relevant aspects can vary depending on the intended patient interface configuration, but the operating principles will be similar, such that the various versions of the plenum insert 3800 disclosed herein can be used with a variety of patient interface configurations.

[0440] 5.3.10.4.1 Plenum Inserts with and without Baffles

[0441] Figure 17-47 Components associated with examples of the present technology are depicted that provide relatively high performance levels (i.e., high humidity) and may also provide a level of impedance to the incoming pressurized air flow that allows it to be used with a wider range of available RPT devices, such as those capable of higher therapeutic pressures and flow rates (e.g., ResMed's AirSense10). Figure 48-74 Depicted are components associated with examples of the present technology that can provide a level of impedance to incoming pressurized air flow that may be optimal for use with more compact and easily traveled RPT devices that may be battery powered and may not be capable of the same high therapeutic pressures and flow rates, such as ResMed's AirMini. For example, Figure 48-74 The version includes bezel 3803, while Figure 17-47 Version 3803 does not include the bezel.

[0442] Due to the wider range of elbow assembly 6600 and RPT device 4000 Figure 17-47 , which is designed to allow greater airflow and minimize impedance taking into account losses that may be caused by certain elbow assemblies 6600 that can allow some leakage of the incoming pressurized air flow directly to the vent structure 3400 without interacting with the HMX material 3806.

[0443] The impedance and flow path through the plenum insert 3800 is optimized by removing the baffle 3803 from within the edge 3812 around the plenum inlet 3811. Additionally, for example, by comparing Fig.41 and 70It can be seen that the annular channel vent 3818 and the radial channel vent 3820 are repositioned. In addition, the annular channel vent 3818 is moved radially outward (with the Fig.70 Compared to Fig.41 ) can reduce impedance and improve ventilation through the annular channel vent 3818.

[0444] 5.3.10.4.2 Tube-down, ultra-compact full-face patient interface

[0445] Figures 93-98 A patient interface 3000 is shown having a positioning and stabilizing structure 3300, a plenum 3200, and a seal-forming structure 3100 according to an example of the present technology. The patient interface 3000 may also include a frame 3350, and the positioning and stabilizing structure 3300 may also include a plurality of headgear straps connected to the frame 3350. Figures 93-98 The example of the patient interface shown can be understood as a tube-down arrangement, wherein the air circuit 4170 is connected to the frame 3350 opposite to the patient's face, so that in use the air circuit 4170 can be directed in a downward or downward direction relative to the patient, so that the air circuit 4170 avoids covering the patient's face, which may be troublesome. In addition, the sealing arrangement of the seal-forming structure 3100 can be understood as an ultra-compact full-face or mouth-nose arrangement. Full-face can be understood to mean that the patient's nose and mouth are sealed from the atmosphere by the seal-forming structure 3100. Ultra-compact can be understood to mean that the seal-forming structure 3100 does not engage the patient's face above the bridge of the nose or above the nasal prominence. In the ultra-compact full-face arrangement, at least a portion of the patient's nasal prominence may remain uncovered. As will be described below, the seal-forming structure 3100 can have an opening corresponding to the patient's mouth. The seal-forming structure 3100 can have another opening corresponding to the patient's nose, and the opening can be further divided into separate openings for each nostril. In addition, this example of the patient interface 3000 may not include a forehead support.

[0446] In some examples of the present technology, the plenum 3200 is at least partially formed by a housing 3210 and a seal-forming structure 3100. The plenum 3200 can include, for example, a cushion module or cushion assembly. The housing 3210 can serve as a chassis for the seal-forming structure 3100.

[0447] As described above, the patient interface 3000 can seal around the nasal airways and oral airways, respectively. The patient interface 3000 can include a plenum 3200 having a nose portion 3230 and an oral portion 3260. The seal-forming structure can be configured to seal around the nasal airways at the nose portion 3230 and around the patient's mouth at the oral portion 3260.

[0448] As explained above, the seal-forming structure 3100 at the nose 3230 may not be located on the nasal bridge area or the nasal ridge area of ​​the patient's face, but may seal against the lower surface of the patient's nose. The nose 3230 may seal against the front surface of the upper lip, the ala and the nasal prominence and / or the lower surface of the nasal prominence. Due to the different shapes and sizes of the patient's facial features, the actual sealing location may vary from patient to patient. The nose 3230 may also be constructed to contact and / or seal to the area of ​​the patient's face between the ala and the nasolabial groove and at the lateral portion of the upper lip closest to the nasolabial groove.

[0449] The seal-forming structure 3100 of the oral portion 3260 can be configured to seal around the periphery of the patient's oral cavity in use. The oral portion 3260 can be configured to seal around the patient's face at, for example, the upper lip, nasolabial groove, cheek, lower lip, and supramental point.

[0450] The plenum chamber 3200 comprises a seal-forming structure 3100 including an oral aperture 3271 and two nostrils 3272. Each nostril 3272 may be positioned on the seal-forming structure 3100 to substantially align with a patient's nostril so as to deliver a flow of air thereto in use.

[0451] The plenum 3200 of the patient interface 3000 can be connected to the frame 3350. The plenum 3200 can be connected to the frame 3350 via a snap-fit ​​connection. In other examples, the plenum 3200 can form a different type of removable connection to the frame 3350, such as a removable press fit, or can be permanently connected to the frame 3350.

[0452] The positioning and stabilizing structure 3300 may include a plurality of straps or strap portions that are connected to the frame 3350 and passed around the patient's head to support the plenum chamber 3200 in a sealed position against the patient's face. The single strap may be formed from multiple lengths of material that have been cut or formed separately and then connected together at their ends to form a longer length, or the single strap may be a single length of material.

[0453] exist Figures 85-93 In the example shown, the positioning and stabilizing structure 3300 includes a pair of upper straps 3310. Each upper strap 3310 is configured to pass between the patient's respective eyes and ears. In addition, the positioning and stabilizing structure 3300 includes a pair of lower straps 3320, which are configured to be located above the patient's cheekbones below the patient's cheekbones. In this example, the inflatable chamber 3200 is held in place by a headgear strap through a four-point connection to the frame 3350.

[0454] In one example, the frame 3350 can be configured to be connected to a swivel elbow assembly 3610 that provides a connection port 3600 for connecting to the air circuit 4170. The swivel elbow assembly 3610 can form a releasable snap fit with the frame 3350, forming a fluid connection between the swivel elbow assembly 3610 and the frame 3350. Thus, the frame 3350 can enable a fluid connection between the swivel elbow assembly 3610 and the interior of the plenum chamber 3200.

[0455] The frame 3350 also includes a pair of upper strap connection points 3315 to which the upper strap 3310 is connected. In this example, each upper strap connection point 3315 includes an aperture formed in the frame 3350. Each upper strap 3310 can be connected to a corresponding upper strap connection point 3315 by passing through the aperture, looping back on itself and securing to itself. Each upper strap 3310 can be fastened to itself via a hook and loop material configured to releasably engage each other when in contact. In an optional example, each upper strap 3310 can pass through a corresponding aperture, return to itself and secure to itself by a strap, clip, etc. In another alternative example, the upper strap 3310 can be connected to the frame 3350 via a side release buckle connection.

[0456] The frame 3350 also includes a pair of lower strap connection points 3325 to which the lower strap 3320 is connected. In this example, each lower strap connection point 3325 includes a magnet. Each lower strap 3320 includes a lower strap clip 3326 that includes a magnet or material that is attracted to the magnet at the lower strap connection point 3325. In this example, each lower strap clip 3326 includes an aperture through which the end of the corresponding lower strap clip 3320 can pass and then loop back and secure to itself, such as with hook and loop material, a strap, a clip, etc. In alternative examples, the lower strap 3320 can be connected to the frame 3350 via a side release buckle connection, on a hook, or via any other suitable connection.

[0457] The positioning and stabilizing structure 3300 may also include one or more of a top overhead strap 3330, a pair of lateral overhead straps 3332, and a neck strap 3334. Figures 93-95In the example shown, the upper strap 3310 and the lower strap 3320 are connected to the ends of the top head strap 3330. The top head strap 3330 is configured to pass over the patient's head and rest against the upper and rear facing surfaces. The top head strap 3330 can be configured to cover the parietal bone of the patient's skull. Each end of the top head strap 3330 is connected to a corresponding one of the upper straps 3310 and is also connected to a corresponding one of a pair of lateral head straps 3332. Each lateral head strap 3332 is connected between the upper strap 3310 and the lower strap 3320 on the corresponding side of the patient's head. The lower ends of the lateral head straps 3332 are connected to each other by a neck strap 3334. The neck strap 3334 can be configured to pass through the sagittal plane and rest against the downward and / or rear facing surface of the patient's head or rest against the back of the patient's neck. The neck strap 3334 may cover the occipital bone of the patient's skull or be located below the occipital bone.

[0458] exist Figures 93-95 In the example shown, the patient interface 3000 includes a vent 3400. The vent 3400 in this example includes a frame 3350 and a passage within a swivel elbow assembly 3610 through which air can flow from the interior of the plenum chamber 3200 to the atmosphere. Air can flow into the swivel elbow assembly 3610 and then flow out to the atmosphere through an external aperture of the swivel elbow assembly 3610 that forms part of the vent 3400.

[0459] 5.3.10.4 Tube-up, ultra-compact full-face patient interface

[0460] Fig.99 Shown include Fig.100 and 101 3200. The patient interface 3000 in this example also includes a positioning and stabilizing structure 3300 to maintain the seal-forming structure 3100 in a sealed position on the patient's face during use. The positioning and stabilizing structure 3300 in this example includes a pair of headband tubes 3340. This arrangement of the patient interface 3000 can also be understood as an ultra-compact full-face arrangement, similar to the patient interface 3000 in terms of how it contacts and seals the patient's face during use. Figures 93-98 This arrangement can also be understood as a tube-up system, where the headband tubes 4170 are in pneumatic communication with the air circuit 4170 above or on the patient's head, so that the air circuit 4170 avoids covering the patient's face during use, which may be troublesome.

[0461] The pair of headband tubes 3340 are connected to each other at their upper ends and each is configured to abut against the upper and side surfaces of the patient's head in use. Each headband tube 3340 can be configured to be located between the corresponding eyes and ears of the patient in use. The lower end of each headband tube 3340 is configured to be fluidically connected to the plenum chamber 3200. In this example, the lower end of each headband tube 3340 is connected to a headband tube connector 3344, which is configured to be connected to the housing 3210 of the plenum chamber 3200. The positioning and stabilizing structure 3300 includes a conduit headband inlet 3390 at the junction of the two headband tubes 3340. The conduit headband inlet 3390 is configured to receive a pressurized airflow, for example, via a bend including a connection port 3600, and allows airflow to enter the headband tube 3340. The headband tube 3340 supplies the pressurized gas flow to the plenum chamber 3200.

[0462] In addition to the headband tube 3340, the positioning and stabilizing structure 3300 may include one or more straps. In this example, the positioning and stabilizing structure 3300 includes a pair of upper straps 3310 and a pair of lower straps 3320. The rear ends of the upper straps 3310 and the lower straps 3320 are connected together. The joint between the upper straps 3310 and the lower straps 3320 is configured to abut against the rear surface of the patient's head in use, providing anchoring for the upper straps 3310 and the lower straps 3320. The front ends of the upper straps 3310 are connected to the headband tubes 3340. In this example, each headband tube 3340 includes a tab 3342 with an opening, through which the corresponding upper strap 3310 can pass, and then loop back and secure to itself to secure the upper headband straps 3310 to the headband tubes 3340. The positioning and stabilizing structure 3300 also includes a lower strap clip 3326 disposed at a front end of each lower strap 3320. Each lower strap clip 3326 is configured to connect to a lower connection point 3325 on the plenum 3200. In this example, the lower strap clip 3326 is magnetically secured to the lower connection point 3325. In some examples, there is also a mechanical engagement between the lower strap clip 3326 and the lower connection point 3325.

[0463] The headband tube connectors 3344 can be configured to allow the patient to breathe ambient air when there is no pressure in the plenum chamber 3200. Each headband tube connector 3344 can include an anti-asphyxia valve (AAV). The AAV in each headband tube connector 3344 can be configured to open when there is no pressure in the plenum chamber 3200 so as to allow air to flow between the interior of the plenum chamber 3200 and the surrounding environment. Each AAV can be biased to block the flow of air from the interior of the plenum chamber 3200 into the corresponding headband tube 3340, but allow air exchange between the plenum chamber 3200 and the surrounding environment. When the headband tube 3340 is pressurized, the AAV in each headband tube connector 3344 can prevent air exchange between the interior of the plenum chamber 3200 and the surrounding environment, but allow air breathed by the patient to flow from the corresponding headband tube 3340 into the plenum chamber 3204.

[0464] Figures 99-101 The plenum chamber 32001 shown in the figure includes a vent 3400. In this example, the vent 3400 includes a plurality of holes. In these examples, the vent 3400 is provided to the shell 3210. In other examples of the present technology, the patient interface 3000 may include a vent module permanently or removably connected to the plenum chamber 3200. In some examples of the present technology, the patient interface 3000 includes a diffuser configured to diffuse the air flowing through the vent 3400. The vent 3400 can be centrally positioned on the shell 3210 to avoid being covered by the patient's bed or bedding during side sleeping. In addition, the vent 3400 in these examples can be positioned relatively downward on the shell 3210 so that the vent 3400 is roughly aligned with the patient's mouth to ensure effective gas removal of exhaled carbon dioxide from the patient's mouth. In addition, because the inlet port 3240 of the inflation chamber 3200 is disposed at a relatively high position on the inflation chamber 3200, the bias flow of air received at the inlet port 3240 can flow through a relatively large volume (e.g., from a higher position to a lower position), which can provide effective gas flushing and reduce the possibility of trapped air pockets that are bypassed by the bias flow.

[0465] 5.3.10.4.4 Tube-up, nasal stent patient interface

[0466] Figure 102-106 An example of a tube-up, nasal stent patient interface is depicted. Figures 99-101Similar to the example shown, the tube-upward aspect may be understood to describe a conduit of the positioning and stabilizing structure 3300 that passes along the respective sides of the patient's head between the respective eyes and ears to connect to the air circuit. The nasal support aspect may be understood to describe a sealing and facial contact arrangement in which the seal-forming structure 3100 is shaped and sized to contact and seal the patient's face around the lower periphery of the patient's nose. The seal-forming structure 3100 may contact the patient's face on or above the upper lip vermilion, along the wings, at or below the nasal prominence, and at or near the patient's nasolabial grooves. In a nasal support sealing arrangement, the seal-forming structure 3100 does not extend beyond the nasal prominence or to the bridge of the nose. In a nasal support arrangement, at least a portion of the patient's nasal prominence may remain uncovered.

[0467] exist Figure 102-106 In the example shown, the seal-forming structure 3100 includes nostril openings 3102 that can be formed through the middle region. These nostril openings 3102 are positioned to be roughly aligned with the patient's corresponding nostrils to provide a pressurized gas flow to the patient's nostrils for inhalation, and to send exhaled gas back into the seal-forming structure 3100 for discharge to the atmosphere via the plenum vent 3400, as further described below. A bridge 3104 can also be provided between the nostril openings 3102. The bridge 3104 can be long enough to be relaxed in an undeformed state so that when the patient's nose contacts the middle region, the bridge 3104 can accommodate the deformation of the seal-forming structure 3100 without stretching. In addition, the bridge 3104 can prevent user setting errors by preventing the patient's nose from being inserted into what would otherwise be a single hole.

[0468] 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.

[0469] The positioning and stabilizing structure 3300 in this example includes a lateral portion 3302 and an upper portion 3304 in the form of a conduit that directs the flowing pressurized gas from the hub 3306 to the 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, such as 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.

[0470] 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 ends 3314 can be constructed or molded from a single piece of silicone.

[0471] The upper portion 3304 of the positioning and stabilizing structure 3300 has ridges and valleys (or folded portions) that allow the upper portion 3304 to conform to the shape of a corresponding portion of a patient's head during 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 bend to different radii of curvature to accommodate patient heads of different shapes and sizes.

[0472] The lateral portion 3302 of the positioning and stabilizing structure 3300 may not be formed with the ridges and valleys of the upper portion 3304. Therefore, 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.

[0473] End 3314 may be connected to a corresponding plenum lateral end 3202. As described above, plenum lateral end 3202 receives a flow of pressurized gas from positioning and stabilizing structure 3300 that passes through plenum 3200, through seal-forming structure 3100, and to the patient's airway.

[0474] The lateral portions 3302 may also each include a tab 3308 that receives a rear strap end portion 3311 of the rear strap 3310. The length of the rear strap 3310 may be adjustable, for example, by a hook and loop material arrangement such that one of the rear strap end portion 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).

[0475] The lateral portion 3302 may also be provided with a sleeve 3312 that cushions the patient's face against the lateral portion 3302. The sleeve 3312 may be constructed of a breathable fabric material having a soft touch.

[0476] The size of each vent and the number of vents may be optimized to achieve a balance between noise reduction while achieving necessary carbon dioxide removal, even during extreme humidification. In the depicted example, the vents of the plenum chamber vent 3400 may not provide the total amount of ventilation 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 through the decoupling structure 3500. The decoupling structure vent 3402 may be used to vent overpressure generated by the RPT device 4000 before reaching the patient, while the plenum chamber vent 3400 may be used to flush carbon dioxide exhaled by the patient during treatment.

[0477] The decoupling structure 3500 may also include a swivel shaft 3502 that allows for a rotatable connection to the air circuit 4170 .

[0478] The rotatability of the decoupling structure 3500 , the elbow 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 .

[0479] 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 catch (not shown) from the hub 3306.

[0480] 5.3.10.4.5 Nasal patient interface

[0481] Fig.107 and Fig.108A patient interface 7000 according to another aspect of the present technology is shown. In this example, the patient interface is a nasal interface type, which includes a seal-forming structure 7200 configured to form a seal around the patient's nose. The seal-forming structure 7200 can seal at or above the patient's nasal prominence. The patient interface 7000 exposes the patient's mouth. The patient interface 7000 includes a frame assembly 7100, a cushion assembly 7175 including a seal-forming structure 7200, an elbow assembly 7600, and a positioning and stabilizing structure (e.g., a headband 7800). The cushion assembly 7175 can be connected to the frame assembly 7100 independently of the elbow assembly 7600, and the elbow assembly 7600 can be connected to the frame assembly 7100 independently of the cushion assembly 7175. The elbow assembly 7600 can include a vent assembly 7700 to allow exhaled air to be flushed into the atmosphere.

[0482] In this example, the frame assembly 7100 can include a shield 7110 and a headband connector 7130 disposed to the shield 7110 to provide a 4-point connection to the headband 7800. The cushion assembly 7175 can include a shell 7180 that is permanently (e.g., co-molded, overmolded) connected to the seal-forming structure or cushion 7200. In one example, the cushion 7200 is composed of a relatively flexible or pliable material (e.g., silicone) and the shell 7180 is composed of a relatively rigid material (e.g., polycarbonate). The shell 7180 and the cushion 7200 cooperate to form an inflatable chamber 7500.

[0483] In this example, the headband connector 7130 includes a shield connecting portion 7132 connected to the shield 7110, a pair of (i.e., right and left) upper headband connector arms 7134 constructed to be connected to corresponding upper headband straps 7802 of the headband 7800, a pair of (i.e., right and left) lower headband connector arms 7154 constructed to be connected to corresponding lower headband straps 7804 of the headband 7800, and a middle portion 7133 interconnecting the upper arm 7134 and the lower arm 7154 with the shield connecting portion 7132.

[0484] In this example, each upper headband connector arm 7134 includes an upper headband connection point in the form of a slot 7135 that is configured to receive a corresponding upper headband strap 7802 of the headband 7800. In this example, each lower headband connector arm 7154 includes a lower headband connection point in the form of a magnetic connector 7155 that is configured to locate and connect to a magnet associated with a headband clip 7160 that is provided to the corresponding lower headband strap 7804 of the headband 7800.

[0485] 5.3.10.5 Treatment with Pneumatic Chamber Inserts

[0486] Figure 75-92Stages of operation of an exemplary RPT system including a plenum insert 3800 are shown. Figure 48-74 The plenum insert 3800 and the patient interface 6000, i.e., the baffle type, are used to illustrate the Figure 75-83 The operation of the plenum insert 3800 system. Figures 84-92 In addition to the flow distribution effect of the baffle 3803 omitted from the scheme shown, Figure 17-47 The operation of the plenum insert 3800 and patient interface 6000, i.e., without the baffle, will be substantially similar. In addition, it should be understood that although the various breathing phases of the patient's inspiration, exhalation, and breath pause are shown, the flow of pressurized air 2000 will continue to be undisturbed throughout the patient's breathing cycle, as will the ventilation flow. In addition, the flow of pressurized air 2000 and the ventilation flow can be understood to pass through the plenum insert 3800 simultaneously and in opposite directions throughout the patient's breathing cycle.

[0487] Figures 75-77 and Figures 84-86 The flow of pressurized air 2000 during inspiration is shown. It can be seen that the patient breathes air from the RPT device through the nose 1001 and mouth 1003 after the air passes through the plenum insert 3800 to be heated and humidified. Fig.76 Also shown is how the baffle 3803 diffuses the air flow as it enters the void 3825 after passing through the port 3811, which distributes the air over the front surface 3828 of the HMX material 3806 so that the air collects as much humidity and heat as possible from the HMX material 3806 to be transferred to the patient during inspiration. Furthermore, a portion of the flow 2002 within the patient interface can be vented to atmosphere - although this is the inhalation phase, at least some venting may always be desired to ensure that adequate carbon dioxide flushing occurs throughout the breathing cycle. At 2003, the air flow bypassing the HMX material 3806 can be seen passing through the bypass channel 2010 formed by the radial channel 3810 and the inner surface 6180 of the plenum 6175. The ventilation flow through the elbow assembly 6600 can be seen at 2001 and then delivered to the surrounding environment at 2002, and it should be understood that the airflow can include bypass flow 2003 and return flow 2004 of air that does not pass through the HMX material 3806 but is exhausted through the radial channel vents 3820 and annular channel vents 3818, as well as airflow through the HMX material 3806 from the patient side of the HMX material 3806, for example after exhalation.

[0488] Fig.78 , 79, 87 and 88 show the flow of pressurized air 2000 through the plenum insert 3800 during apnea, i.e., during the cessation of lung expansion or contraction that occurs between the inspiration and expiration phases. Since the patient is not inhaling air through the HMX material 3806, the pressure of the flow within the plenum 6175 causes the flow to recirculate through the plenum insert 3800 in the opposite direction. Some of the flow may return through the HMX material 3806, while some of the flow may return to 2004 via radial passages 3810 and bypass the HMX material 3806 at 2003. Additionally, some of the flow may not pass through the HMX material 3806. Instead, that portion of the flow may be recirculated back out of the plenum insert 3800 via annular passage vents 3818 and radial passage vents 3820.

[0489] Figures 80-83 and Figures 89-92 Airflow during the patient's exhalation phase is shown. The patient breathes through their nose 1002 and mouth 1004, and the air is exhausted to the atmosphere 2002 through the elbow 2001, although if the patient is receiving CPAP therapy, the pressurized air flow 2000 into the patient interface can continue. As can be seen, a portion of the exhaled air will travel out of the patient interface by traveling through the HMX material 3806, which receives heat and moisture for the next inhalation phase. Depending on the conditions in the plenum insert 3800 (e.g., humidity and temperature), moisture can be absorbed and / or adsorbed by the HMX material 3806, and moisture can also condense on the HMX material 3806. In addition, a portion of the exhaled air can bypass the 2003 HMX material 3806 by traveling along radial channels 3810 to ensure that carbon dioxide is discharged from dead space areas within the patient interface that may restrict flow circulation.

[0490] 5.4RPT device

[0491] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electrical components and is configured to execute, in whole or in part, one or more algorithms 4300, such as any of the methods described herein. The RPT device 4000 can be configured to generate an air flow for delivery to the airway of a patient, such as for treating one or more respiratory conditions described elsewhere in this document.

[0492] In one form, the RPT device 4000 is constructed and arranged to deliver an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or a positive pressure of at least 10 cmH2O, or a positive pressure of at least 20 cmH2O.

[0493] 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.

[0494] The pneumatic path of the RPT device 4000 can include one or more air path items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 capable of supplying positive pressure air (e.g., a blower 4142), an outlet muffler 4124, and one or more converters 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0495] One or more air path items may be located 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.

[0496] 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.

[0497] 5.4.1 Mechanical and pneumatic components of RPT device

[0498] 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.

[0499] 5.4.1.1 Air filter

[0500] An RPT device according to one form of the present technology may include an air filter 4110, or multiple air filters 4110.

[0501] In one form, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140 .

[0502] In one form, an outlet air filter 4114 , such as an antimicrobial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000 .

[0503] 5.4.1.2 Silencer

[0504] An RPT device according to one form of the present technology may include a muffler 4120, or a plurality of mufflers 4120.

[0505] In one form of the present technology, an inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140 .

[0506] In one form of the present technology, an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 .

[0507] 5.4.1.3 Pressure generator

[0508] In one form of the present technology, the pressure generator 4140 for generating a positive pressure air flow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. The blower is capable of delivering an air supply, for example, at a rate of up to about 120 liters per minute, at a positive pressure ranging from about 4 cmH2O 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. 2013 / 020167.

[0509] The pressure generator 4140 is controlled by the treatment device controller 4240.

[0510] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (e.g., a compressed air reservoir), or a bellows.

[0511] 5.4.1.4 Converter

[0512] The transducer may be internal to the RPT device, or external to the RPT device. An external transducer may be located on or form part of, for example, an air circuit (e.g., 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.

[0513] In one form of the present technology, one or more transducers 4270 may be located 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 property of the air flow at that point in the pneumatic path, such as flow, pressure, or temperature.

[0514] In one form of the present technology, one or more transducers 4270 may be located proximal to the patient interface 3000 .

[0515] In one form, the signal from converter 4270 may be filtered, such as by low pass filtering, high pass filtering, or band pass filtering.

[0516] 5.4.1.4.1 Flow sensor

[0517] 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.

[0518] In one form, a signal representing flow rate from flow sensor 4274 is received by central controller 4230.

[0519] 5.4.1.4.2 Air pressure sensor

[0520] 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.

[0521] In one form, signals from pressure sensor 4272 are received by central controller 4230.

[0522] 5.4.1.4.3 Motor speed converter

[0523] 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 the 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.

[0524] 5.4.1.5 Anti-overflow valve

[0525] In one form of the present technology, an anti-spillback valve 4160 is located 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 the motor 4144, for example.

[0526] 5.4.2 RPT device electrical components

[0527] 5.4.2.1 Power supply

[0528] The power source 4210 may be located inside or outside the outer housing 4010 of the RPT device 4000 .

[0529] 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.

[0530] 5.4.2.2 Input device

[0531] 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. The buttons, switches, or dials may be physically connected to the external housing 4010 in one form, or may be wirelessly connected to a receiver in another form, which is electrically connected to the central controller 4230.

[0532] In one form, input device 4220 may be constructed and arranged to allow a person to select values ​​and / or menu options.

[0533] 5.4.2.3 Central Controller

[0534] In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0535] Suitable processors may include x86 INTEL processors, 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.

[0536] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0537] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0538] 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 .

[0539] 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 .

[0540] In some forms of the present technology, the central controller 4230 is configured to implement one or more of the methods described herein, such as one or more algorithms 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 control settings for the ventilator or detect a breathing-related event by analyzing stored data, such as from any of the sensors described herein.

[0541] 5.4.2.4 Clock

[0542] The RPT device 4000 may include a clock 4232 connected to a central controller 4230 .

[0543] 5.4.2.5 Treatment device controller

[0544] In one form of the present technology, the treatment device controller 4240 is a treatment control module that forms part of the algorithm executed by the central controller 4230.

[0545] 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.

[0546] 5.4.2.6 Protection circuit

[0547] One or more protection circuits 4250 in accordance with the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0548] 5.4.2.7 Memory

[0549] According to one form of the present technology, the RPT device 4000 includes a memory 4260, such as a non-volatile memory. In some forms, the memory 4260 may include a battery powered static RAM. In some forms, the memory 4260 may include a volatile RAM.

[0550] The memory 4260 may be located on the PCBA 4202. The memory 4260 may be in the form of an EEPROM or a NAND flash memory.

[0551] 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.

[0552] In one form of the present technology, the memory 4260 acts as a non-transitory computer-readable storage medium on which are stored computer program instructions, such as one or more algorithms, representing one or more of the methods described herein.

[0553] 5.4.2.8 Data Communication System

[0554] 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.

[0555] 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.

[0556] In one form, remote external communication network 4282 is the Internet. Data communication interface 4280 may be connected to the Internet using wired communication (eg, via Ethernet or fiber optic) or wireless protocols (eg, CDMA, GSM, LTE).

[0557] In one form, the local external communications network 4284 utilizes one or more communications standards, such as Bluetooth or consumer infrared protocols.

[0558] In one form, the remote external device 4286 can be one or more computers, such as 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, such a remote external device 4286 can be accessed by appropriately authorized personnel (such as a clinician).

[0559] The local external device 4288 may be a personal computer, a mobile phone, a tablet or a remote control device.

[0560] 5.4.2.9 Output devices including optional displays and alarms

[0561] 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.

[0562] 5.4.2.9.1 Display Driver

[0563] 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.

[0564] 5.4.2.9.2 Display

[0565] 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 indicating whether the eight corresponding segments are to be activated to display the particular character or symbol.

[0566] 5.5 Air circuit

[0567] The air circuit 4170 according to one aspect of the present technology is a conduit or tube that is constructed and arranged to allow air flow to flow between two components, such as the RPT device 4000 and the patient interface 3000, in use.

[0568] In particular, 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 may be separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.

[0569] 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.

[0570] 5.5.1 Oxygen delivery

[0571] 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 .

[0572] 5.6 Humidifier

[0573] 5.6.1 Humidifier Overview

[0574] 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.

[0575] 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.

[0576] 5.6.2 Humidifier components

[0577] 5.6.2.1 Water storage tank

[0578] According to one arrangement, the humidifier 5000 may include a water reservoir 5110, which is configured to hold or retain a certain volume of liquid (e.g., water) to evaporate for humidifying the air flow. The water reservoir 5110 may be configured to maintain a predetermined maximum water capacity so as to provide sufficient humidification for at least the duration of a respiratory therapy session, such as a 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.

[0579] According to one aspect, water reservoir 5110 is configured to humidify air flow from RPT device 4000 as the air flow passes 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.

[0580] According to one form, the reservoir 5110 may be, for example, along a Figure 5A and Figure 5B The lateral orientation is shown removed from the humidifier 5000.

[0581] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any holes and / or among its subassemblies, such as when the reservoir 5110 is displaced and / or rotated from its normal operating 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.

[0582] 5.6.2.2 Conductive part

[0583] 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 a volume of liquid 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.

[0584] 5.6.2.3 Humidifier reservoir dock

[0585] 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.

[0586] 5.6.2.4 Water level indicator

[0587] The humidifier reservoir 5110 may include Figure 5A-5B Water level indicator 5150 is shown. In some forms, water level indicator 5150 may provide a user (such as patient 1000 or a caregiver) with one or more indications regarding the amount of water volume in humidifier reservoir 5110. The one or more indications provided by 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.

[0588] 5.6.2.5 Humidifier converter

[0589] 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 sent to a controller (such as the central controller 4230 and / or the humidifier controller 5250). In some forms, the humidifier converter may be located outside the humidifier 5000 (such as in the air circuit 4170) when sending the output signal to the controller.

[0590] 5.6.2.51 Pressure converter

[0591] The humidifier 5000 may be provided with one or more pressure transducers 5212 in lieu of or in addition to the pressure sensor 4272 provided in the RPT device 4000 .

[0592] 5.6.2.5.2 Flow rate converter

[0593] In lieu of or in addition to the flow sensor 4274 provided in the RPT device 4000 , the humidifier 5000 may be provided with one or more flow transducers 5214 .

[0594] 5.6.2.5.3 Temperature converter

[0595] 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 also include a temperature sensor 5216 for detecting the ambient air temperature.

[0596] 5.6.2.5.4 Humidity converter

[0597] In some forms, the humidifier 5000 may include one or more humidity sensors 5218 that detect the humidity of a gas (e.g., 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.

[0598] 5.6.2.6 Heating elements

[0599] In some cases, the humidifier 5000 can be provided with a heating element 5240 to provide heat input to a volume of water in the humidifier reservoir 5110 and / or to one or more of the air stream. The heating element 5240 can include a heat generating component, such as a resistive electric heating rail. A suitable example of the 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.

[0600] In some forms, the heating element 5240 may be disposed in the humidifier base 5006, wherein the heating element 5240 may be primarily provided by, for example, Figure 5B The conduction shown in provides heat to the humidifier reservoir 5110.

[0601] 5.6.2.7 Humidifier controller

[0602] According to one arrangement of the present technology, Figure 5C As shown in , the humidifier 5000 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.

[0603] In one form, the humidifier controller 5250 may receive as input, for example, measurements of air flow, water properties (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.

[0604] like Figure 5C As shown in the figure, 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.

[0605] 5.7 Respiratory waveform

[0606] Figure 6A typical breathing waveform of a model when a person is sleeping 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, peak inspiratory flow Qpeak, 0.4L / s, expiratory time Te, 2.4s, peak expiratory flow Qpeak, -0.5L / s. The total duration of breathing Ttot is about 4s. People usually breathe at a rate of about 15 breaths / minute (BPM), with a ventilation volume Vent, about 7.5L / minute. A typical duty cycle, the ratio of Ti to Ttot is about 40%.

[0607] 5.8 Glossary

[0608] For the purposes of this technical disclosure, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, alternative definitions may apply.

[0609] 5.8.1 Overview

[0610] 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, such as atmospheric air enriched with oxygen.

[0611] 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.

[0612] For example, the ambient humidity relative to the humidifier may be the humidity of the air directly surrounding the humidifier, such as 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.

[0613] In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

[0614] 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 emanating from a mask or patient interface. Ambient noise may be generated by sound sources outside the room.

[0615] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which therapy pressure is automatically adjusted between minimum and maximum limits, e.g., from breath to breath, based on the presence or absence of an indication of an SDB event.

[0616] 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 when there is no indication of partial upper airway obstruction.

[0617] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, reference to flow rate will be to a scalar quantity, i.e., a quantity having only magnitude. In other cases, reference to flow rate will be to a vector quantity, i.e., a quantity having both magnitude and direction. Flow rate may be given the symbol Q. "Flow rate" is sometimes shortened to simply "flow" or "airflow".

[0618] 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 washout 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 breathing system.

[0619] Humidifier: The term humidifier shall be understood as a humidifying device constructed and arranged, or constructed with a physical structure, capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air flow to improve a patient's medical respiratory condition.

[0620] Leakage: The term leakage is to be understood 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 bend to the ambient environment.

[0621] 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.

[0622] 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.

[0623] Noise, Vent (Acoustic): Vent noise in this document refers to the noise generated by the flow of air through any vent, such as the vent in a patient interface.

[0624] Patient: A person, whether or not they have a respiratory illness.

[0625] Pressure: Force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm 2 and hectopascal. 1 cmH20 is equal to 1 g-f / cm2, which is about 0.98 hectopascal. In this specification, unless otherwise specified, pressure is given in cmH2O.

[0626] 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.

[0627] 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.

[0628] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0629] 5.8.1.1 Materials

[0630] Silicone or Silicone Elastomer: Synthetic rubber. In this specification, references to silicone are 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. (Year? Required?)

[0631] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0632] 5.8.1.2 Mechanical properties

[0633] Resilience: The ability of a material to absorb energy when elastically deformed and release that energy when deflated.

[0634] Resilient: Releases substantially all of its energy when deflated. Includes, for example, certain silicones and thermoplastic elastomers.

[0635] Hardness: The ability of a material to resist deformation (e.g., as described by Young's modulus, or the indentation hardness scale measured on a standardized sample size).

[0636] "Soft" materials may include silicone or thermoplastic elastomers (TPEs), and may deform easily, for example, under finger pressure.

[0637] "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and may not deform easily, for example, under finger pressure.

[0638] Rigidity (or stiffness) 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, such as compression, tension, bending, or torsion. The structure or component may offer different resistance in different directions.

[0639] Flexible structure or component: A structure or component that will change shape (eg, bend) within a relatively short period of time (eg, 1 second) when made to support its own weight.

[0640] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads normally encountered in use. An example of such a use may be to place and maintain a patient interface in sealing relationship with the entrance to a patient's airway, for example under a load of about 20 to 30 cmH2O pressure.

[0641] 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.

[0642] 5.8.2 Breathing cycle

[0643] Apnea: 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 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.

[0644] Respiratory rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0645] Duty cycle: the ratio of inspiratory time Ti to total breathing time Ttot.

[0646] Effort (breathing): The effort made by a spontaneously breathing person trying to breathe.

[0647] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0648] Flow Limitation: Flow limitation is to be considered as a state of events 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 respiratory cycle, it may be described as inspiratory flow limitation. Where flow limitation occurs during the expiratory portion of the respiratory cycle, it may be described as expiratory flow limitation.

[0649] Types of flow-limited inspiratory waveforms:

[0650] (i) Flat: Having a rise followed by a relatively flat portion and then a fall.

[0651] (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.

[0652] (iii) Chair shape: has a single local peak at the leading edge followed by a relatively flat section.

[0653] (iv) Reverse chair shape: has a relatively flat section followed by a single local peak located at the trailing edge.

[0654] Hypopnea: According to some definitions, hypopnea would be considered a decrease in flow, but not a cessation of flow. In one form, hypopnea is considered to occur when flow decreases below a threshold rate 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:

[0655] (i) The patient's respiration decreases by 30% for at least 10 seconds with an associated 4% desaturation; or

[0656] (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%.

[0657] Hyperpnea: Increased air flow to above normal levels.

[0658] 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.

[0659]

[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 may be quantified, such as a value (1) for open, and a value of zero (0) for closed (obstructed).

[0660] Positive End Expiratory Pressure (PEEP): The pressure above atmospheric pressure that exists in the lungs at the end of exhalation.

[0661] Peak flow (Qpeak): The maximum value of the flow during the expiratory portion of the respiratory flow waveform.

[0662] Respiratory flow, patient air flow, respiratory air flow (Qr): These terms may be understood to refer to the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow", which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0663] 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 amount of air inhaled) is equal to the expiratory volume Ve (the amount 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, such as an average.

[0664] (Inspiratory) Time (Ti): Duration of the inspiratory portion of the respiratory flow waveform.

[0665] (Inspiratory) Time (Ti): Duration of the expiratory portion of the respiratory flow waveform.

[0666] (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.

[0667] Typical recent ventilation: The ventilation value around which the recent ventilation values ​​Vent tend to cluster over some predetermined time scale, ie a measure of the central tendency of the recent ventilation values.

[0668] Upper airway obstruction (UAO): includes both partial and total upper airway obstruction. This may be associated with a state of flow limitation, where flow increases only slightly, or even decreases (Starling impedance behavior), as the pressure difference across the upper airway increases.

[0669] Ventilation (Vent): A measurement of the flow of gases exchanged by a patient's respiratory system. Measurements of ventilation may include one or both of the 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.

[0670] 5.8.3 Ventilation

[0671] Adaptive servo ventilator (ASV): A servo ventilator with a variable rather than fixed target ventilation. The variable target ventilation may be derived from some characteristic of the patient, such as the patient's breathing characteristics.

[0672] 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.

[0673] Cycling: 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 be cycling to stop delivering breaths.

[0674] Expiratory Positive Airway Pressure (EPAP): The base pressure to which the intra-breath varying pressure is added to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0675] 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 Π(Φ) is zero at the end of exhalation, i.e., Π(Φ) = 0 when Φ = 1, then EEP is equal to EPAP.

[0676] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of a breath.

[0677] 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 in ventilator target achievement, rather than the difference actually achieved.

[0678] 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.

[0679] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the initiation 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.

[0680] Swing: A term equivalent to pressure support.

[0681] Triggered: When a ventilator delivers breathable air to a spontaneously breathing patient, it is considered to be triggered to do so at the beginning of the breath portion of the breathing cycle by the patient's effort.

[0682] 5.8.4 Anatomy

[0683] 5.8.4.1 Facial anatomy

[0684] Ala: The outer lining or "wing" of each nostril (plural: alar)

[0685] Alar tip: The outermost point on the wing of the nose.

[0686] 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.

[0687] Auricle: The entire external visible part of the ear.

[0688] (Nose) Framework: The framework of the nose includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0689] (Nose) Cartilage framework: The cartilage framework of the nose includes septal cartilages, lateral cartilages, major cartilages and minor cartilages.

[0690] Columella: The strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0691] Columellar angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort horizontal plane (where both lines intersect at the lower point of the nasal septum).

[0692] Frankfurt horizontal plane: A line extending from the lowest point of the orbital margin to the left oblique area. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0693] Glabella: The most prominent point on the forehead in the mid-sagittal plane located on the soft tissue.

[0694] Lateral nasal cartilage: A generally triangular plate of cartilage. Its superior margin is attached to the nasal bone and the frontal process of the maxilla, and its inferior margin is connected to the greater alar cartilage.

[0695] Greater alar cartilage: A cartilaginous plate located beneath the lateral nasal cartilage. It surrounds the anterior curvature 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.

[0696] 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.

[0697] 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.

[0698] Nasolabial angle: the angle between the columella and the upper lip (which intersect at the lower point of the nasal septum).

[0699] Auricular base: The lowest point where the auricle attaches to the facial skin.

[0700] Auricular base: The highest point where the auricle attaches to the facial skin.

[0701] 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.

[0702] 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.

[0703] Chin forward point: located on the soft tissue, the front midpoint of the chin.

[0704] Ridge (nose): The nasal ridge is the midline protrusion of the nose extending from the nasal bridge point to the nasal protuberance point.

[0705] 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.

[0706] Nasal point: The most concave point on the soft tissue covering the frontonasal suture area.

[0707] Septal Cartilage (Nose): The septal cartilage forms part of the nasal septum and divides the front of the nasal cavity.

[0708] 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.

[0709] Subnasal point: The point on the soft tissue where the columella meets the upper lip in the midsagittal plane.

[0710] 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

[0711] 5.8.4.2 Anatomy of the skull

[0712] Frontal Bone: The frontal bone includes a large vertical portion (the squama) which corresponds to the area called the forehead.

[0713] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0714] 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.

[0715] 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.

[0716] 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.

[0717] Occipital Bone: The occipital bone is located at the back and lower part of the skull. It contains the 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.

[0718] Orbit: The bony cavity in the skull that holds the eyeball.

[0719] Parietal: The parietal bones are the bones that when joined together form the roof and sides of the skull.

[0720] 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.

[0721] Zygomatic bones: The face includes two zygomatic bones, which are located on the upper and side parts of the face and form the protrusions of the cheeks.

[0722] 5.8.4.3 Anatomy of the respiratory system

[0723] 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.

[0724] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0725] Lung: The respiratory organ of humans. The conducting zone of the lungs contains the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone contains the respiratory bronchioles, alveolar ducts, and alveoli.

[0726] 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.

[0727] 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) (the nasal part of the pharynx), the oropharynx (mesopharynx) (the oral part of the pharynx), and the hypopharynx (hypopharynx).

[0728] 5.8.5 Patient interface

[0729] Anti-Asphyxia Valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to atmosphere in a fail-safe manner.

[0730] Elbow: An elbow is an example of a structure that redirects the axis of the air flow directed therethrough at 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 some forms, the elbow may be rotatable relative to a mating component, such as approximately 360 degrees. In some forms, the elbow may be removable from a mating component, such as via a snap connection. In some 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.

[0731] Frame: A frame will be understood to mean a 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.

[0732] Headgear: A headgear will be understood 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 supports, straps, and reinforcements configured to position and maintain a patient interface in position on a 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.

[0733] Film: A film is to be understood as meaning a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.

[0734] Plenum: A mask plenum will be understood to mean a portion of the patient interface having walls at least partially enclosing a volume of space which, in use, has air inflated therein to a pressure above atmospheric pressure. The housing may form part of the wall of the mask plenum.

[0735] Seal: can be a noun form ("seal"), which refers to a structure, or a verb form ("seal"), which refers to an effect. 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.

[0736] Shell: Shell will be understood 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.

[0737] Reinforcement: A reinforcement will be understood to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0738] Support: A support will be understood to mean a structural component designed to increase the compression resistance of another component in at least one direction.

[0739] Swivel (n): A subassembly of components 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 angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably comprises a pair of matching cylindrical conduits. There may be little or no air flow leakage from the swivel when in use.

[0740] Lace (noun): A structure designed to resist tension.

[0741] Vent (noun): A structure that allows air flow from the interior of a mask or tube to ambient air for clinically 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 treatment pressure.

[0742] 5.8.6 Structure Shape

[0743] Products according to the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or an impeller. The three-dimensional structures may be combined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe the orientation, position, function, or some other characteristics of the relevant surfaces. 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.

[0744] To help describe the shape of three-dimensional structures and surfaces, first consider a cross section through the surface of the structure at a point p. FIG. 3B to FIG. 3F , which show examples of cross sections at points p on the surface and the resulting plane curves. Figures 3B to 3FAlso shown is the outward normal vector at p. The outward normal vector at p away from the surface. In some examples, the surface is depicted from the point of view of an imaginary person standing upright on the surface.

[0745] 5.8.6.1 Curvature in one dimension

[0746] The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, 1 / radius of a circle that touches the curve only at p).

[0747] Positive curvature: If the curve turns toward the outward normal at p, then the curvature at that point will be positive (if an imaginary person were to leave 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.

[0748] Zero curvature: If the curve is a straight line at point p, then the curvature will be zero (if the imaginary person leaves point p, they can walk horizontally, neither up nor down). Figure 3D .

[0749] Negative curvature: If the curve turns away from the outward normal at p, then the curvature in that direction at that point will be negative (if the imaginary person leaves point p, they must be walking 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.

[0750] 5.8.6.2 Curvature of a Two-Dimensional Surface

[0751] 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 including an 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 quantity, such as a relatively small quantity. Figures 3B to 3F The plane curve in may be an example of such multiple sections at specific points.

[0752] Principal curvature and direction: The normal directions along which the curvature of a curve takes its maximum and minimum values ​​are called principal directions. FIG. 3B to FIG. 3F In the example, the maximum curvature occurs at 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.

[0753] Surface Region: A connected set of points on a surface. The set of points in a region can have similar characteristics, such as curvature or sign.

[0754] Saddle region: The region where the principal curvatures at each point have opposite signs, i.e. one is positive and the other is negative (depending on which way the imaginary person turns, they can go uphill or downhill).

[0755] Dome area: The area where the principal curvatures at every point have the same sign, e.g. two positive ("concave dome") or two negative ("convex dome").

[0756] Cylindrical region: A region in which one of the principal curvatures is zero (or is zero within manufacturing tolerances, for example) and the other principal curvature is non-zero.

[0757] Planar region: A surface region where both principal curvatures are zero (or are zero within manufacturing tolerances, for example).

[0758] Surface edge: The boundary or limit of a surface or area.

[0759] Path: In some forms of the present technology, 'path' will be understood to mean a path in a 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).

[0760] Path length: In some forms of the present technology, 'path length' will be understood to mean the distance along the surface from f(0) to f(1), i.e. the distance along the 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).

[0761] 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 may 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 may not be a 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'.

[0762] 5.8.6.3 Space curve

[0763] 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, such as 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.

[0764] 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.

[0765] 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.

[0766] 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.

[0767] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. Fig.3O and 3P .

[0768] 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 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.

[0769] refer to Figure 3PAccording to the right-hand rule, a space curve that turns toward the right-hand binormal direction can be considered to have 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).

[0770] Similarly, and referring to the left-hand rule (see Fig.3O ), a space curve that turns toward the left-handed binormal direction 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 .

[0771] 5.8.6.4 Holes

[0772] A surface may have one-dimensional pores, for example pores defined by planar curves or by spatial curves. A thin structure (e.g., a membrane) having pores may be described as having one-dimensional pores. See, for example Fig. 3I A one-dimensional hole in a surface bounded by a planar curve for the structure shown.

[0773] A structure can have two-dimensional pores, such as pores defined by a surface. For example, a pneumatic tire has a two-dimensional pore 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 pore. See, for example, Figure 3L The cushion and the Figure 3M and Figure 3N , showing 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.

[0774] 5.9 Other notes

[0775] Unless the context clearly indicates and provides a numerical range, it should be 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 intermediate values ​​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 range. In the case where the range includes one or both of the limits, the present technology also includes ranges excluding either or both of those included limits.

[0776] 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 and, unless otherwise indicated, may be used with any suitable significant figures to the extent permitted or required by practical technical implementation.

[0777] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by those 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.

[0778] When a specific material is considered to be used for the construction of a component, an obvious alternative material with similar properties can be used as its substitute. In addition, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus can be manufactured together or separately.

[0779] 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.

[0780] All disclosures mentioned herein are incorporated by reference to disclose and describe methods and / or materials as those disclosed themes. 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.

[0781] The terms “comprises” and “comprising” should be interpreted as referring to elements, components or steps in a non-exclusive manner, indicating that the mentioned elements, components or steps may exist or be utilized or combined with other elements, components or steps not explicitly mentioned.

[0782] The main headings used in the detailed description are included only for the convenience of the reader's reference and should not be used to limit the inventive subject matter found in the entire disclosure or claims. The subject headings should not be used to interpret the scope of the claims or the limitations of the claims.

[0783] Although the present technology has been described with reference to specific examples, it should be understood that these examples 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 can be described or illustrated in a certain order, this order is not required. Those skilled in the art will recognize that this order can be modified, and / or its aspects of the order can be performed simultaneously or even synchronously.

[0784] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology.

[0785] 5.10 Reference Symbols List

[0786]

[0787]

[0788]

[0789]

Claims

1. A patient interface, comprising: a plenum chamber pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure, the plenum chamber comprising a plenum chamber 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 contact and seal an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an aperture therein so that a flow of air at the treatment pressure is delivered to at least 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 stabilising structure configured for retaining the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilising structure comprising a strap, the strap being constructed and arranged such that at least a portion of the strap covers an area of ​​the patient's head that, in use, is above a corresponding supra-auricular base point of the patient; a plenum insert configured to be positioned and retained within the plenum and between an entrance to the patient's airway and the plenum port; and a vent structure configured to allow gas exhaled by the patient to flow continuously 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 plenum insert has a plenum insert port positioned in pneumatic communication with the plenum port such that air flow at the treatment pressure passes through the plenum insert port after passing through the plenum port; wherein the plenum insert has an outer surface configured to be positioned adjacent an inner surface of the plenum; wherein, when the plenum insert is positioned and retained within the plenum chamber, a radial passage is formed by an inner surface of the plenum chamber and an outer surface of the plenum insert, allowing gas to pass between a patient-proximal side of the plenum insert and a patient-distal side of the plenum insert via the radial passage during use; and wherein the patient interface is configured to allow the patient to breathe from the ambient environment through their mouth without a flow of pressurized air through the plenum inlet port, or wherein the patient interface is configured such that the patient's mouth is uncovered.

2. A patient interface according to claim 1, wherein: the seal-forming structure being constructed and arranged to be positioned against the patient's face and around the patient's nostrils and mouth in use such that a flow of air at the treatment pressure is delivered through the apertures to the patient's nostrils and mouth, and Therein, the patient interface is configured to allow the patient to breathe from the ambient environment through their mouth without a flow of pressurized air through the plenum inlet port.

3. A patient interface according to one of claims 1 or 2, wherein: The seal-forming structure and the plenum chamber have a generally triangular profile to cover the patient's nose and mouth while not covering the patient's eyes during use.

4. A patient interface according to one of claims 1 to 3, wherein: The plenum insert also includes three radial channels, which are positioned circumferentially around the plenum insert port and are oriented to direct air within the seal-forming structure and the plenum from corresponding corner areas of the seal-forming structure and the generally triangular profile of the plenum from the patient proximal side of the plenum insert to the patient distal side of the plenum insert.

5. A patient interface according to one of claims 1 to 4, wherein: The plenum insert further includes a plurality of radial channels positioned circumferentially about the plenum insert port and oriented to direct the seal-forming structure and air within the plenum from a patient-proximal side of the plenum insert to a patient-distal side of the plenum insert.

6. A patient interface according to one of claims 1 to 5, wherein: The plenum insert also includes a heat and moisture exchanger (HMX) material configured to receive and retain water from the patient's exhaled gas and to desorb the retained water into the air flow at the therapeutic pressure passing through the HMX material while providing the air flow at the therapeutic pressure to the plenum port.

7. A patient interface according to one of claims 1 to 6, wherein: The plenum insert is permanently connected to the plenum.

8. A patient interface system comprising: A patient interface according to one of claims 1 to 7; a respiratory pressure therapy device configured to pressurize the flow of air at said therapy pressure; as well as An air circuit is configured to direct the air flow from the respiratory pressure therapy device to the patient interface.

9. The patient interface system of claim 8, wherein: Humidifier not included.

10. A patient interface system according to claim 8 or 9, wherein: The air circuit may include a tube having a heating element configured to heat the air flow, or the tube may include no heating element.

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