Air adapter tube and medical device and system including same

Abstract

The utility model relates to an air adapter tube and a medical device and system comprising the same. An air adapter tube for diagnosing and / or treating respiratory disorders, the air adapter tube comprising a tubular body configured for delivering pressurized therapeutic air between a proximal end of the tubular body and a distal end of the tubular body, the proximal end being configured for connection to a patient interface, the far end is configured to be connected to an air conveying pipe; and a sensor configured to generate a signal for diagnosing and / or treating a respiratory disorder based on air passing at the proximal end.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application Nos. 63 / 387,325 filed on December 14, 2022, 63 / 487,311 filed on February 28, 2023, 63 / 487,317 filed on February 28, 2023, and 63 / 515,681 filed on July 26, 2023, each of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention and improvement of breathing-related disorders. The present technology also relates to medical devices or devices and their uses. Background Art

[0004] 2.2 Description of related technologies

[0005] 2.2.1 Human respiratory system and its disorders

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

[0007] The airway includes a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to move from the inhaled air to the venous blood, while carbon dioxide moves in the opposite direction. The trachea is divided into the right main bronchi and the left main bronchi, which are eventually divided into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further branches of the airway lead to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory region. See "Respiratory Physiology", 9th edition, published by John B. West, Lippincott Williams & Wilkins in 2012.

[0008] There is a range of breathing disorders. Some disorders can be characterised by specific events such as apnea, hypopnea and hyperpnea.

[0009] 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.

[0010] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB), characterized by events including upper airway occlusion or obstruction during sleep. It is caused by an abnormally small upper airway and the normal loss of muscle tone in the tongue, soft palate and posterior oropharyngeal wall area during sleep. This condition causes affected patients to stop breathing, usually for 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness, and it may cause cardiovascular disease and brain damage. The syndrome is a common disorder, especially common in middle-aged overweight men, but the affected people may not be aware of this problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0011] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory control system in which there are rhythmic alternating cycles of increased and decreased ventilation, called CSR cycles. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with repeated awakenings from sleep, which can lead to severe sleep disruption, increased sympathetic nerve activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0012] Respiratory failure is an umbrella term for respiratory disorders in which the lungs are unable to take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure can encompass some or all of the following disorders.

[0013] Patients with respiratory insufficiency (a form of respiratory failure) may become abnormally short of breath during exercise.

[0014] 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.

[0015] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that have certain common features. These symptoms 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: difficulty breathing on exertion, chronic cough, and sputum production.

[0016] Neuromuscular disease (NMD) is a broad term that covers many diseases and ailments that impair muscle function directly via intrinsic muscle pathology or indirectly via 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 diseases can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disease: characterized by muscle damage that worsens within a few months and causes death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disease: characterized by muscle damage that worsens over many years and only slightly reduces life expectancy (e.g., limb girdle, facioscapulohumeral muscular dystrophy, and myotonic dystrophy). Symptoms of respiratory failure in NMD include: increasing general fatigue, dysphagia, dyspnea during exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and mood changes.

[0017] Chest wall disorders are a group of chest deformities that result in inefficient coupling between the respiratory muscles and the thorax. These disorders are usually characterized by restrictive defects with the potential for prolonged 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.

[0018] A range of therapies have been used to treat or ameliorate such conditions. In addition, such therapies can be used to prevent breathing disorders in otherwise healthy individuals. However, these therapies have a number of disadvantages.

[0019] 2.2.2 Therapy

[0020] Various respiratory therapies, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), and high flow therapy (HFT) have been used to treat one or more of the above-mentioned respiratory disorders.

[0021] 2.2.2.1 Respiratory pressure therapy

[0022] Respiratory pressure therapy is the application of air supplied to the airway entrance at a controlled target pressure that is nominally positive relative to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as a tank or breastplate ventilator).

[0023] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). Its mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway obstruction, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy can be voluntary, and therefore patients may choose not to comply with therapy if they find the device used to deliver this therapy to be one or more of the following: uncomfortable, difficult to use, expensive, and unsightly.

[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 therapies can be improved.

[0025] Invasive ventilation (IV) provides ventilation support to patients who are no longer able to breathe effectively on their own, and can be provided using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0026] 2.2.2.2 Flow therapy

[0027] Not all respiratory therapies are intended to deliver prescribed treatment pressures. Some respiratory therapies are intended to deliver prescribed respiratory volumes by delivering an inspiratory flow rate curve (possibly superimposed on a positive baseline pressure) within a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy can only supplement the patient's own spontaneous breathing with a regulated or enriched gas flow. In one example, high flow therapy (HFT) can be to provide a continuous, heated, humidified air flow to the airway entrance through an unsealed or open patient interface at a "treatment flow rate" that is roughly constant throughout the respiratory cycle. The treatment flow is nominally set to exceed the patient's peak inspiratory flow. HFT has been used to treat OSA, CSR, respiratory failure, COPD and other respiratory disorders. A mechanism of action is that high flow rate air at the airway entrance improves ventilation efficiency by flushing or flushing out exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as dead space therapy (deadspace therapy, DST). Other benefits can include increased warmth and humidity (possibly beneficial in secretion management) and the possibility of appropriately increasing airway pressure. As an alternative to a constant flow rate, the therapy flow rate may follow a curve that varies during the respiratory cycle.

[0028] Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. A physician may prescribe a continuous flow of oxygen-enriched air at a specified oxygen concentration (21% to 100% of the oxygen fraction in ambient air) at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.) for delivery to the patient's airway.

[0029] 2.2.2.3 Supplemental oxygen

[0030] For some patients, oxygen therapy can be combined with respiratory pressure therapy, or HFT, by adding supplemental oxygen to the pressurized gas flow. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplemental oxygen.

[0031] 2.2.3 Respiratory therapy system

[0032] These respiratory therapies can be provided by a respiratory therapy system or device.Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.

[0033] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0034] Another form of therapy system is a mandibular repositioning device.

[0035] 2.2.3.1 Patient interface

[0036] The patient interface can be used to engage the respiratory equipment to its wearer, for example by providing an air flow to the airway entrance. 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 therapy to be applied, the patient interface can, for example, form a seal with an area of ​​the patient's face to facilitate delivery of gas at a pressure sufficiently different from the ambient pressure (e.g., at a positive pressure of about 10 cmH2O relative to the ambient pressure) to achieve therapy. For other forms of therapy, such as delivering oxygen, the patient interface may not include a seal sufficient to facilitate delivery of the gas supply to the airway at a positive pressure of about 10 cmH2O. For flow therapies such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically to avoid complete sealing. An example of such a patient interface is a nasal cannula.

[0037] Certain other mask systems may not be functionally suitable for use in this field. For example, a purely decorative mask may not be able to maintain the appropriate pressure. A mask system used for underwater swimming or diving may be constructed to prevent the ingress of water from a higher pressure outside, but may not be able to maintain the internal air at a pressure higher than the ambient pressure.

[0038] Certain masks may be clinically undesirable for the present technology, for example where they block airflow through the nose and only allow airflow through the mouth.

[0039] Certain masks may be uncomfortable or impractical with the present technology if they require the patient to insert a portion of the mask structure into their mouth in order to form and maintain a seal with their lips.

[0040] Some masks may not be suitable for use while sleeping, such as when sleeping on your side in bed with your head on a pillow.

[0041] The design of a patient interface presents many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly between individuals. Because the head is composed of bones, 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 respiratory therapy.

[0042] Due to these challenges, some masks are obtrusive, unsightly, expensive, ill-fitting, difficult to use, and uncomfortable, especially when worn for long periods of time or when the patient is unfamiliar with the system. A mask of the wrong size may result in 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 may not be as comfortable as ideally worn for long periods of time (e.g., hours). This discomfort may result in reduced patient compliance with therapy. This is even more true if the mask is worn during sleep.

[0043] CPAP therapy is very effective in treating certain breathing disorders, provided the patient adheres to the therapy. If the mask is uncomfortable or difficult to use, the patient may not adhere to 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 be able to clean their mask, which may affect patient compliance.

[0044] 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 use in other applications.

[0045] For these reasons, patient interfaces for delivering CPAP during sleep represent a unique field.

[0046] 2.2.3.1.1 Sealing structure

[0047] The patient interface may include a seal-forming structure. Since the seal-forming structure 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.

[0048] The patient interface can be characterized in part according to the design intent of where the seal-forming structure engages with the face during use. In one form of the 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 the patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a 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 the patient interface, the seal-forming structure may include an element that surrounds the mouth area during use, for example by forming a seal on the lower lip area of ​​the face. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth area during use. These different types of patient interfaces may be named by their manufacturers under various names, including nasal masks, full-face masks, nasal pillows, nasal flutters, and oronasal masks.

[0049] For example, due to the different shapes, structures, variability, and sensitive areas of a patient's face, a seal-forming structure that may be effective in one area of ​​the patient's face may not be appropriate in another area. For example, a seal on swimming goggles that covers the patient's forehead may not be appropriate for use on the patient's nose.

[0050] Certain seal-forming structures may be designed for mass manufacturing so that one design fits and is 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-produced patient interface, one or both must adapt to form a seal.

[0051] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface, with the seal-forming structure 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 in order to achieve a seal.

[0052] Another type of seal-forming structure incorporates a flap 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 types of seal-forming portions, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. In addition, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming structure may wrinkle or buckle during use, causing leaks.

[0053] Another type of seal-forming structure may include friction-fit elements, such as for insertion into a nostril, however some patients find these elements uncomfortable.

[0054] Another form of seal-forming structure can use adhesive to achieve the seal. Some patients may find it inconvenient to frequently apply and remove adhesive on their face.

[0055] A range 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 010 / 135785.

[0056] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan-Bennett, Inc. Another nasal pillow or nasal puff is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0057] ResMed Limited has manufactured the following products that incorporate nasal pillows: ResMed Limited has manufactured the following products that incorporate nasal pillows: SWIFT TM Nasal pillow mask, SWIFT TM II nasal pillow mask, SWIFT TM LT nasal pillow mask, SWIFT TM FX Nasal Pillows Mask and MIRAGE LIBERTY TMFull Face Masks. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: International Patent Application WO 2004 / 073,778 (which describes aspects of ResMed Limited's SWIFT™ nasal pillows), U.S. Patent Application 2009 / 0044808 (which describes other aspects of ResMed Limited's SWIFT™ LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe aspects of ResMed Limited's MIRAGE LIBERTY™ full face mask); International Patent Application WO 2009 / 052,560 (which describes other aspects of ResMed Limited's SWIFT™ FX nasal pillows).

[0058] 2.2.3.1.2 Positioning and stabilization

[0059] 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 destroy 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.

[0060] One technique is to use an adhesive. See, for example, US Patent Application Publication No. US 2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

[0061] Another technique is to use one or more straps and / or stabilizing straps.Many of these straps have one or more problems of poor fit, bulkiness, discomfort, and inconvenience of use.

[0062] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0063] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to deliver one or more of the above-mentioned multiple therapies, such as by operating the device to generate an air flow for delivery to an airway interface. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Therefore, an RPT device can also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0064] Air pressure generators are known in the context of applications such as industrial scale ventilation systems. However, air pressure generators for medical applications have special requirements that are not met by more general air pressure generators, such as reliability, size and weight requirements for medical devices. In addition, 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.

[0065] One example of a special requirement for certain RPT devices is acoustic noise.

[0066] Table of noise output levels of existing RPT devices (one sample only, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0067] RPT device name A-weighted sound pressure level dB(A) Years (approximately) C Series TangoTM 31.9 2007 C Series TangoTM with Humidifier 33.1 2007 S8 EscapeTMII 30.5 2005 S8 EscapeTM II with H4iTM Humidifier 31.1 2005 S9 AutoSetTM 26.5 2010 S9 features AutoSetTM from H5i humidifier 28.6 2010

[0068] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators, such as the ResMed Stellar 1000 and 1000 ventilators for adults and pediatrics, are also available. TM series, which can provide invasive and non-invasive non-dependent ventilatory support to a range of patients to treat a variety of conditions such as but not limited to NMD, OHS and COPD.

[0069] ResMed Elisée TM 150 ventilator and ResMed VS III TM Respirators can provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of a variety of conditions. These ventilators provide capacity ventilation modes and pressure ventilation modes with single-limb circuits 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 at a positive pressure. The outlet of the RPT device is connected to a patient interface such as those described above via an air circuit.

[0070] An unlimited number of options are available to the designer of the device. Design criteria often conflict, which means that some design choices are out of the ordinary or unavoidable. In addition, some aspects of comfort and efficacy may be highly sensitive to small subtle changes in one or more parameters.

[0071] 2.2.3.3 Air circuit

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

[0073] 2.2.3.4 Humidifier

[0074] Delivering an unhumidified air stream may result in airway drying. Using a humidifier with an RPT device and patient interface produces humidified gas, thereby minimizing drying of the nasal mucosa and increasing 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 cool air.

[0075] A range of artificial humidification devices and systems are known, however they do not meet the special requirements of medical humidifiers.

[0076] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to ambient air when needed, typically while the patient is asleep or resting (e.g., in a hospital). Medical humidifiers placed at the bedside can be small. Medical humidifiers can be configured to humidify and / or heat only the air stream delivered to the patient, without humidifying and / or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, evaporative coolers, etc.) can also humidify the air inhaled by the patient, however these systems also humidify and / or heat the entire room, which can be uncomfortable for the occupants. In addition, medical humidifiers can have more stringent safety constraints than industrial humidifiers.

[0077] Although many medical humidifiers are known, they may have one or more disadvantages. Some medical humidifiers may provide inadequate humidification and may be difficult or inconvenient for some patients to use.

[0078] 2.2.3.5 Oxygen source

[0079] Experts in the field have recognized that exercise can provide long-term benefits to patients with respiratory failure, slowing the progression of the disease, improving quality of life, and extending the life of patients. However, most fixed forms of exercise, such as treadmills and stationary bicycles, are too strenuous for these patients. Therefore, the need for mobility has long been recognized. Until recently, such mobility has been achieved through the use of small compressed oxygen tanks or oxygen cylinders mounted on carts with push wheels. The disadvantages of these oxygen tanks are that they contain a limited amount of oxygen and are heavy, weighing about 50 pounds when mounted.

[0080] Oxygen concentrators have been used for about 50 years to supply oxygen for respiratory therapy. Traditional oxygen concentrators are large and cumbersome, making it difficult and impractical to use them for ordinary walking activities. Recently, companies that manufacture large, fixed oxygen concentrators have begun to develop portable oxygen concentrators (POCs). The advantage of POCs is that they can produce a theoretically unlimited supply of oxygen. In order to make these devices small and easy to move, the various systems required to produce oxygen-enriched gas are compressed. POCs seek to use the oxygen they produce as efficiently as possible to minimize weight, size, and power consumption. This can be achieved by delivering oxygen in the form of a series of pulses, with each pulse or "bolus" timed to coincide with the start of inspiration. This mode of therapy is called pulsed oxygen delivery (POD) or demand mode, as opposed to traditional continuous flow delivery that is more suitable for fixed oxygen concentrators.

[0081] 2.2.3.6 Data Management

[0082] There may be a clinical reason for obtaining data to determine whether a patient prescribed respiratory therapy is "compliant," e.g., 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 a patient needs to use the RPT device for at least four hours each night for 21 out of 30 consecutive days to be considered compliant. To determine a patient's compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing the therapy for a patient using the RPT device, calculate usage over a predetermined time period, and compare to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may inform the patient of the third part of compliance.

[0083] Transmitting therapy data to a third party or external system may benefit other aspects of patient therapy.

[0084] Existing methods of communicating and managing such data can be one or more of the following: expensive, time consuming, and error prone.

[0085] 2.2.3.7 Ventilation techniques

[0086] Some forms of therapy systems may include ventilation to allow flushing of exhaled carbon dioxide. Ventilation may allow gas to flow from an interior space of the patient interface (eg, a pneumatic chamber) to a space outside the patient interface, such as to the environment.

[0087] The vent may include an orifice through which gas may flow when the mask is in use. Many such vents are noisy. Others may become blocked during use, thereby providing inadequate flushing. Some vents may disturb the sleep of the patient's 1000 bed partner 1100, for example, by noise or concentrated airflow.

[0088] ResMed Limited has developed many improved mask ventilation technologies, see International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0089] Noise table of existing masks (ISO 17510-2:2007, pressure of 10cmH2O at 1m)

[0090]

[0091] (*One sample only, measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744)

[0092] The sound pressure values ​​for various objects are listed below

[0093]

[0094] 2.2.4 Screening, diagnosis and surveillance systems

[0095] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary disorders, and clinical experts are usually involved in applying the system. PSG usually includes placing 15 to 20 contact sensors on the patient to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep apnea includes two nights of observing the patient in the clinic, one night of pure diagnosis, and the second night of the clinician titrating the treatment parameters. Therefore, PSG is both expensive and inconvenient. In particular, it is not suitable for screening / diagnosis / monitoring sleep apnea at home.

[0096] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening often gives a true / false result indicating whether a patient's SDB is severe enough to warrant further investigation, whereas diagnosis may yield clinically actionable information. Screening and diagnosis tend to be a one-time process, whereas monitoring for the progression of a condition can continue indefinitely. Some screening / diagnosis systems are only for screening / diagnosis, while some can also be used for monitoring.

[0097] A clinical expert may be able to adequately screen, diagnose, or monitor a patient based on visually observed PSG signals. However, there are situations where a clinical expert may not be available or where a clinical expert may not be affordable. Different clinical experts may have different opinions about a patient's condition. Furthermore, a given clinical expert may apply different criteria at different times. Utility Model Content

[0098] The present technology is directed to providing medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders that have improved one or more of comfort, cost, efficacy, ease of use and manufacturability.

[0099] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0100] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing breathing disorders.

[0101] One aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0102] One form of the present technology includes a positioning and stabilizing structure configured to provide a force to maintain a seal-forming structure in a therapeutically effective position on a patient's head. The positioning and stabilizing structure includes at least one strap.

[0103] One form of the present technology includes a patient interface comprising an inflatable chamber, a seal-forming structure, and a positioning and stabilizing structure.

[0104] One form of the present technology includes a patient interface that includes a plenum chamber that can be pressurized to a therapeutic pressure that is at least 4 cmH2O above ambient air pressure. The plenum chamber includes at least one plenum chamber inlet port that is sized and structured to receive a flow of air at a therapeutic pressure for the patient to breathe. The patient interface also includes a seal-forming structure that is constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway. The seal-forming structure has holes therein so that the flow of air at the therapeutic pressure is delivered to at least the entrance of the patient's nostrils. The seal-forming structure is constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use. The patient interface also includes a positioning and stabilizing structure to provide a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head.

[0105] Another aspect of one form of the present technology is a series of modular elements that can be interconnected to form different styles of patient interfaces.

[0106] In one form, each modular element has at least two versions or styles. These versions or styles can be used interchangeably with each other to form different modular assemblies.

[0107] One form of the present technology includes a respiratory therapy system comprising: a patient interface; an air circuit configured to be removably coupled to the patient interface; a radio frequency identification (RFID) tag associated with the patient interface, the RFID tag configured to store information about the patient interface; an antenna; and a transceiver, wherein the transceiver can be configured to wirelessly receive information stored on the RFID tag and transmit the information to a controller when the air circuit can be coupled to the patient interface.

[0108] In one aspect of the present technology, at least one of the antenna or the transceiver may be located on an adapter configured to couple the air circuit to a patient interface.

[0109] In another aspect, at least one of the antenna or the transceiver is located at a proximal end of the air loop.

[0110] In one form, at least one of the antenna or the transceiver may be housed within a cover located proximal to the air circuit.

[0111] In one aspect, the RFID tag may be one or more of a near field communication (NFC) tag, an ultra high frequency (UHF) tag, a Bluetooth tag, or an ultra wideband (UWB) tag.

[0112] In various aspects, the controller may be incorporated as part of a respiratory pressure therapy device.

[0113] In one form, the controller may be configured to automatically configure at least one setting of the respiratory pressure therapy device based on information received from the transceiver regarding the patient interface.

[0114] In aspects, the antenna may be a multi-directional antenna including multiple antennas oriented at different angles relative to each other.

[0115] In another form, an air circuit for a respiratory therapy system may include: a proximal end and a distal end, wherein the proximal end may be configured to be removably coupled to a patient interface and the distal end may be configured to be removably coupled to a respiratory pressure therapy device; and a multi-dimensional antenna located at the proximal region of the air circuit, wherein the multi-dimensional antenna may include a plurality of antennas oriented at different angles relative to each other.

[0116] In various aspects, the multi-dimensional antenna may include two antennas.

[0117] In form, the two antennas may be oriented at right angles to each other.

[0118] In a further aspect, the multi-dimensional antenna includes three or more antennas.

[0119] In some forms, the plurality of antennas may include at least a first antenna and a second antenna, wherein the first antenna and the second antenna may be oriented at an angle of approximately 30 degrees to approximately 120 degrees relative to each other.

[0120] In various aspects, the plurality of antennas may be configured to operate at frequencies ranging from about 10 MHz to about 12 GHz.

[0121] In another form, a respiratory therapy system may include: a respiratory pressure therapy device; and a controller configured to: receive information about a patient interface from an RFID tag associated with the patient interface; and perform a response action based at least in part on the received information about the patient interface, the response action comprising configuring one or more of the settings of the respiratory pressure therapy device; generating an indication recommending a new patient interface or a new patient interface cushion; generating an indication suggesting a different size or different type of patient interface or cushion; generating an indication that an air circuit is not coupled to the patient interface or is not properly coupled to the patient interface; or

[0122] Information about the patient interface is transmitted to a cloud server.

[0123] In various aspects, a controller may be incorporated as part of a respiratory pressure therapy device.

[0124] In form, the information received about the patient interface may include one or more of: the type or size of the patient interface; the type or size of the cushion; the manufacturing batch number or serial number of the patient interface; a timestamp; a date of use; or the length of time the patient interface is used.

[0125] In various aspects, information regarding the patient interface can be received at the start of a therapy session administered by the respiratory therapy system.

[0126] In a further aspect, information regarding the patient interface may be received at regular intervals throughout a therapy session administered by the respiratory therapy system.

[0127] In some forms, the frequency with which information regarding the patient interface is received may be increased if irregularities are detected in the received information.

[0128] Another aspect of one form of the present technology relates to an air adapter tube for diagnosing and / or treating a respiratory disorder. The air adapter tube also includes a tubular body configured to deliver pressurized therapeutic air between a proximal end of the tubular body and a distal end of the tubular body, the proximal end being configured to connect to a patient interface, and the distal end being configured to connect to an air delivery tube; and a sensor configured to generate a signal based on air passing at the proximal end for diagnosing and / or treating a respiratory disorder.

[0129] Another aspect of one form of the present technology relates to an air adapter tube for diagnosing and / or treating a respiratory disorder. The air adapter tube also includes a tubular body configured to deliver pressurized therapeutic air between a proximal end of the tubular body and a distal end of the tubular body, the proximal end being configured to connect to a patient interface, and the distal end being configured to connect to an air delivery tube; and a sensor configured to generate a signal indicative of a sleeping position of the patient.

[0130] Another aspect of one form of the present technology relates to an air adapter tube for diagnosing and / or treating a respiratory disorder. The air adapter tube also includes a tubular body configured to deliver pressurized therapeutic air between a proximal end of the tubular body and a distal end of the tubular body, the proximal end being configured to connect to a patient interface, and the distal end being configured to connect to an air delivery tube; and a sensor configured to generate a signal indicative of a respiratory and / or biomarker of gas exhaled by the patient.

[0131] Another aspect of one form of the present technology relates to an air adapter tube for diagnosing and / or treating a respiratory disorder. The air adapter tube also includes a proximal end and a distal end, wherein the proximal end is configured to be removably coupled to a patient interface and the distal end is configured to be removably coupled to an air delivery tube; a sensor configured to generate a signal based on a sensed physical quantity, and an antenna configured to receive data from an RFID tag.

[0132] In one example, the sensor includes a pressure sensor.

[0133] In one example, the sensor includes an accelerometer.

[0134] In one example, the sensor is a CO2 sensor.

[0135] In one example, the CO 2 sensor is configured to detect CO 2 accumulation, rebreathing CO 2 levels, and / or breathing comfort.

[0136] In one example, the CO2 sensor is configured to be positioned between the patient and the vent on the patient interface.

[0137] In one example, the CO2 sensor is configured to detect end-tidal CO2.

[0138] In one example, the sensor is a volatile organic compound (VOC) sensor configured to detect a biomarker in the patient's breath.

[0139] In one instance, the sensor is a CO2 sensor and / or a volatile organic compound (VOC) sensor, and wherein the CO2 sensor and / or (VOC) sensor is configured for pre-treatment analysis before pressurized therapeutic air is delivered to the patient interface.

[0140] In one example, the tubular body includes a flexible material.

[0141] In one example, the inner diameter of the tubular body is between about 10-15 mm.

[0142] In one example, the inner diameter of the tubular body is 12 mm.

[0143] In one example, the length of the tubular body is between about 8.5-10 cm.

[0144] In one example, the length is about 8.5 cm.

[0145] In one example, the outer surface of the tubular body includes or is covered with a textile material.

[0146] In one example, the tubular body includes a helix.

[0147] In one example, the proximal end includes a mechanical connector configured to connect to a patient interface.

[0148] In one example, the mechanical connector includes a split spring coil having a pair of opposing clips configured to be connected to the patient interface.

[0149] In one example, the mechanical connector includes an iso-tapered body configured to connect with the patient interface by an interference fit or a friction fit.

[0150] In one example, the air adapter tube further includes a flexible printed circuit supporting the sensor at the proximal end.

[0151] In one example, the flexible circuit includes an antenna, which may be an NFC antenna.

[0152] In one example, the antenna is configured to wirelessly transmit the collected sensor data to an external device including a smartphone or a flow generator.

[0153] In one example, the flexible printed circuit includes at least one wire connection point that connects the antenna to at least one wire extending along and from the tubular body.

[0154] In one example, a flexible printed circuit includes linear portions supporting electronic components and at least one flexible curved portion between the linear portions.

[0155] In one example, one of the electronic components is a pressure sensor and another of the electronic components is an accelerometer sensor configured to generate a signal indicative of a sleeping position of the patient.

[0156] In one example, the electronic components include one or more sensors configured to generate a signal representative of respiration and / or a biomarker indicative of patient health.

[0157] In one example, the one or more sensors include a CO2 sensor or a volatile organic compound (VOC) sensor.

[0158] In one example, the air adapter tube further includes a temperature sensor configured to generate a signal representative of a temperature within the tubular body.

[0159] In one example, the air adapter tube further includes a first adapter element at the proximal end, the first adapter element supporting the sensor.

[0160] In one example, the first adapter element includes an outer cylindrical surface having a port, and the sensor protrudes radially inwardly into the port and / or through the port.

[0161] In one example, the air adapter tube also includes silicone to seal the port adjacent the sensor.

[0162] In one example, the air adapter tube further includes a second adapter element that couples and seals with the membrane and the helix of the tubular body.

[0163] In one example, the air adapter tube further includes a cuff portion connected to the first adapter element, and the first adapter element and the cuff portion form an annular space configured to receive a flexible printed circuit supporting the sensor.

[0164] In one example, the first adapter element includes at least one feature configured to support the flexible printed circuit, the at least one feature including a fastener and / or an adhesive.

[0165] In one example, the air adapter tube further includes a vent along a periphery of the first adapter element.

[0166] In one example, the air adapter tube further includes a waterproof pressure equalizing membrane provided to the vent and configured to regulate differential pressure at the proximal end.

[0167] In one example, the air adapter tube further includes an electrical connector provided at the distal end of the tubular body, the electrical connector being configured to electrically connect to a corresponding electrical connector of a hot air delivery tube.

[0168] In one example, an electrical connector includes a lead frame configured to transmit power and / or signals.

[0169] In one example, the air adapter tube further includes an indicator or guide adjacent the distal end configured to align with a corresponding indicator or guide of the hot air delivery tube.

[0170] In one example, the air adapter tube further includes at least one wire extending along the tubular body and electrically connecting the electrical connector to the sensor and / or the flexible printed circuit.

[0171] In one example, the air adapter tube further includes a mechanical connector provided at the distal end of the tubular body, the mechanical connector being configured to mechanically connect to a corresponding mechanical connector of the hot air delivery tube.

[0172] In one example, the air adapter tube further includes a power source configured to provide power to the sensor or the flexible printed circuit.

[0173] In one example, the air adapter tube further includes a plurality of sensors including at least one first sensor, a second sensor, and a third sensor. The first sensor is configured to generate a signal based on air passing through the proximal end during treatment for diagnosing and / or treating a respiratory disorder. The second sensor is configured to generate a signal indicative of a patient's sleeping position. The third sensor is configured to generate a signal indicative of a respiratory and / or biomarker of gas exhaled by the patient prior to applying treatment.

[0174] In one instance, the air adapter tube further includes a first electrical connector configured to couple a first electrical wire configured to deliver power to the air delivery tube and a second electrical connector configured to couple a second electrical wire configured to send and receive data to and from the air delivery tube.

[0175] In one example, the antenna is a multi-directional antenna that includes multiple antennas oriented at different angles relative to each other.

[0176] In one example, the multi-directional antenna includes two antennas.

[0177] In one example, the plurality of antennas includes at least a first antenna and a second antenna, wherein the first antenna and the second antenna are oriented at an angle of about 30 degrees to about 120 degrees relative to each other.

[0178] In one example, the plurality of antennas are configured to have a frequency of about 10 MHz to about 12 GHz.

[0179] In one example, the sensor is supported at the proximal end of the air adapter tube and / or its tubular body.

[0180] Another aspect of one form of the present technology relates to a medical device for diagnosing and / or treating a patient with a breathing disorder, the medical device comprising a flow generator configured to generate pressurized breathable air for the patient, a patient interface configured to seal with the airway of the patient, an air delivery tube for delivering the pressurized breathable air from the flow generator to the patient interface, and an air adapter tube.

[0181] In one example, the flow generator is configured to be controlled based on output from the sensor.

[0182] Another aspect of one form of the present technology relates to a method for diagnosing and / or treating a patient, the method comprising: connecting an air adapter tube between an air delivery tube and a patient interface; generating a signal with a sensor; and transmitting the signal for use in diagnosing or treating the patient.

[0183] Another aspect of one form of the present technology relates to a system comprising an air adapter tube and at least one hardware processor configured to perform operations including controlling when the sensor is configured to sense a physical quantity.

[0184] In one example, the sensor is controlled based on the determined patient position.In one example, the sensor is controlled to sense the physical quantity before positive air pressure is delivered to the air adapter tube.

[0185] In one example, the sensor is controlled to sense the physical quantity based on determining that no positive air pressure is delivered to the air adapter tube.

[0186] Another aspect of one form of the present technology relates to a system comprising an air adapter tube and at least one hardware processor configured to perform operations including changing at least one therapy parameter based on a generated sensor signal.

[0187] In one example, the system further includes a patient interface including an RFID tag including data received by an antenna of the air adapter tube.

[0188] The described methods, systems, devices, and apparatus may be implemented to improve the functionality of a processor, such as a dedicated computer, a respiratory monitor, and / or a respiratory therapy device. In addition, the described methods, systems, devices, and apparatus may provide improvements in the art of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0189] Of course, parts of these aspects may form sub-aspects of the present technology. In addition, each aspect in the sub-aspects and / or aspects may be combined in various ways, and also constitute additional aspects or sub-aspects of the present technology.

[0190] Other features of the present technology will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0191] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals refer to like elements, including:

[0192] Figures 1A to 1C Various configurations of respiratory therapy systems are shown in use.

[0193] Figure 2 A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0194] Figure 3A 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 being upstream of the patient interface and the patient interface is defined as being downstream of the blower, regardless of the actual direction of flow 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.

[0195] Figure 3B A schematic diagram of the electrical components of an RPT device according to one form of the present technology is shown.

[0196] Figure 3C A schematic diagram of an algorithm implemented in a RPT device according to one form of the present technology is shown.

[0197] Figure 4A Shown is a perspective view of a cushion of a patient interface configured to be worn by a patient and to deliver pressurized air to the patient's nose and the patient's mouth.

[0198] Figure 4B A perspective view of a cushion of a patient interface configured to be worn by a patient and to deliver pressurized air to the patient's nose is shown.

[0199] Figure 4C Shows that Figure 4A The pad or Figure 4B A perspective view of a tube used together with a gasket.

[0200] Figure 4D Shows that Figure 4A The pad or Figure 4B A perspective view of a rigid arm used together with a pad.

[0201] Figure 4E Shows that Figure 4A A perspective view of a headgear strap used together with a pad.

[0202] Figure 4F Shows that Figure 4B A perspective view of a headgear strap used together with a pad.

[0203] Figure 4G Shown is a removable assembly to Figure 4C The tube or Figure 4D Front view of a pair of sleeves on a rigid arm.

[0204] Figure 4H Shown is a removable mount to Figure 4D Front view of the complete sleeve on the rigid arm.

[0205] Fig. 4I Shown is a removable mount to Figure 4D A front perspective view of yet another alternative form of a complete sleeve for a rigid arm.

[0206] Figure 4J Is worn connected to Figure 4C The tube, Figure 4E Headband and Figure 4G The sleeve Figure 4A Front view of the patient with the liner.

[0207] Figure 4K Is worn connected to Figure 4D Rigid arm, Figure 4E Headband and Figure 4H The sleeve Figure 4A Front view of the patient with the liner.

[0208] Figure 4L Is worn connected to Figure 4C The catheter tip Figure 4B The padding and Figure 4F Front view of patient wearing headgear.

[0209] Figure 4M Is worn connected to Figure 4D Rigid arm, Figure 4F Headband and Fig. 4I The sleeve Figure 4B Front view of the patient with the liner.

[0210] Figure 4N yes Figure 4L Isolated perspective view of ventilation.

[0211] Fig.4O yes Figure 4M An isolated perspective view of a portion of an air circuit.

[0212] Figure 4P is a schematic diagram showing possible combinations of patient interfaces.

[0213] Figure 5A A schematic diagram of a medical system according to various aspects of the present invention is shown.

[0214] Figure 5B A schematic diagram of an alternative medical system according to aspects of the present invention is shown.

[0215] Fig. 6A and 6B A perspective view of a proximal portion of an air circuit according to aspects of the present invention is shown.

[0216] Figure 6C Shows the aspects based on Figure 6B Front view of the circuit board shown in .

[0217] Fig. 7A and Figure 7B A front view of an exemplary patient interface according to aspects of the present invention is shown ( Fig. 7A ) and side view ( Figure 7B ).

[0218] Fig. 8A and Figure 8B A rear view of an alternative exemplary patient interface according to aspects of the present invention is shown ( Fig. 8A ) and top view ( Figure 8B ).

[0219] 9A to 9D Various configurations of two or more antennas according to aspects of the present invention are shown.

[0220] FIG. 10A to FIG. 10D Various configurations between various patient interfaces and air circuits are shown.

[0221] Fig.11 is a perspective view of an air adapter tube according to an example of the present technology viewed from the distal end.

[0222] Fig.12 Observed from a distance Fig.11 Another perspective view of the air adapter tube.

[0223] Fig.13 Observed from close up Fig.11 Another perspective view of the air adapter tube.

[0224] Fig.14 Observed from close up Fig.11 Another perspective view of the air adapter tube.

[0225] Fig.15 is connected to the air delivery pipe according to the technical example Fig.11 A perspective view of the air adapter tube.

[0226] Fig.16 is connected to the air delivery pipe according to the technical example Fig.11 Another perspective view of the air adapter tube.

[0227] Fig.17 is connected to the air delivery pipe according to the technical example Fig.11 A perspective view of the air adapter tube.

[0228] Fig.18 is connected to an air delivery tube according to an example of the present technology Fig.11 Another perspective view of the air adapter tube.

[0229] Fig.19 is connected to an air delivery tube according to an example of the present technology Fig.11 Another perspective view of the air adapter tube.

[0230] Fig. 20 According to an example of the present utility model Fig.11 Exploded view of the air adapter tube.

[0231] Fig.21 According to an example of the present utility model Fig.11 Another exploded view of the air adapter tube.

[0232] Fig. 22 According to an example of the present utility model Fig.11 A partial cross-sectional view of the air adapter tube.

[0233] Fig.23 According to an example of the present utility model Fig.11 Exploded partial cutaway view of the air adapter tube.

[0234] Fig.24 According to an example of the present utility model Fig.11 Another partial exploded cross-sectional view of the air adapter tube.

[0235] Fig.25 is an exploded view of an end portion of an air delivery tube according to one example of the present technology.

[0236] Fig.26 According to an example of the present technology Fig.25 Another exploded view of the end of the air delivery tube.

[0237] Fig. 27 According to an example of the present technology Fig.11 A perspective view of the proximal end of the air adapter tube with the cuff portion removed.

[0238] Fig.28 According to an example of the present technology Fig.11 Another perspective view of the proximal end of the air adapter tube with the cuff removed.

[0239] Fig.29 According to an example of the present technology Fig.11 Another perspective view of the proximal end of the air adapter tube with the cuff removed.

[0240] Fig.30 According to an example of the present technology Fig.11 End view of the proximal end of the air adapter tube with the cuff removed.

[0241] Fig.31 According to an example of the present utility model Fig.11 A partial cross-sectional view of the air adapter tube.

[0242] Fig.32 According to an example of the present utility model Fig.11 Cross-section of the air adapter tube with the collar removed.

[0243] Fig.33 is connected to an air delivery tube according to an example of the present technology Fig.11 A perspective view of the air adapter tube.

[0244] Fig.34 is through Fig.33 Cross-sectional view along line 34-34.

[0245] Fig.35 is through Fig.33 Cross-sectional view along line 35-35.

[0246] Fig.36 is connected to a patient interface according to an example of the present technology Fig.11 Cross-sectional view of the air adapter tube.

[0247] Fig.37 is manually disconnected from the patient interface according to an example of the present technology Fig.11 Cross-sectional view of the air adapter tube.

[0248] Fig.38is a plan view of a flexible printed circuit according to an example of the present technology.

[0249] Fig.39 According to an example of the present utility model Fig.11 Exploded view of the air adapter tube. DETAILED DESCRIPTION

[0250] Before further describing the present technology in detail, it should be understood that the present technology 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 the present invention are only used to describe the specific examples discussed herein, and are not intended to be limiting.

[0251] The following description is provided about various examples that can share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combined with one or more features of another example or other examples. In addition, any single feature or combination of features in any one example can constitute another example.

[0252] Reference will now be made in detail to various aspects of the present invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numerals will be used throughout the drawings to refer to the same or similar parts. The term "distal end" refers to the part farthest from a user (e.g., a patient). Conversely, the term "proximal end" refers to the part closest to the user.

[0253] The foregoing general description and the following detailed description are merely exemplary and illustrative, and are not intended to limit the features claimed. As used herein, the terms "comprises," "comprising," "having," "including," or other variations thereof are intended to cover non-exclusive inclusions, such that a process, method, article, or device comprising a series of elements includes not only these elements, but may also include other elements not expressly listed or inherent to such a process, method, article, or device. In the present utility model, relative terms such as "about," "substantially," "generally," and "approximately" are used for possible variations of ±10% of the value or feature.

[0254] 5.1 Therapy

[0255] In one form, the present technology includes a method for treating a breathing disorder comprising applying positive pressure to an airway entrance of a patient 1000 .

[0256] In certain examples of the present technology, a positive pressure air supply is provided to the patient's nasal passages via one or both nostrils.

[0257] In some examples of the present technology, mouth breathing is limited, restricted, or prevented.

[0258] 5.2 Respiratory therapy system

[0259] In one form, the present technology includes a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may include an RPT device 4000 for supplying an air flow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800 .

[0260] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows receiving a supply of air under positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and passed along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient sleeps in a supine sleeping position.

[0261] Figure 1B A system is shown including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask, receiving a positive pressure air supply 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.

[0262] Figure 1C A system is shown including a patient 1000 wearing a patient interface 3000 in the form of a full face mask receiving a positive pressure air supply from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered along an air circuit 4170 to the patient 1000. The patient sleeps in a side-lying sleeping position.

[0263] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electronic components and is configured to execute one or more algorithms 4300, such as all or part of 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, for example, for treating one or more respiratory conditions described elsewhere in this document.

[0264] 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 4 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0265] like Figure 1A , Figure 1B and Figure 1C As shown, the patient 1000 can use the respiratory therapy system in various positions. Therefore, the position of the patient interface 3000, for example relative to the air circuit 4170 or other aspects of the respiratory therapy system, can change throughout the use process.

[0266] 5.3 Patient Interface

[0267] According to one aspect of the present technology, Figure 3A The non-invasive patient interface 3000 shown 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 can be provided by one or more physical components. In some forms, one physical component can provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the airway entrance of the patient so as to maintain a positive pressure at the airway entrance of the patient 1000. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0268] 5.3.1 Inflatable chamber

[0269] The plenum 3200 has a perimeter shaped to complement the surface contour of an average human face in the area where a seal will be formed in use. In use, the boundary edge of the plenum 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire perimeter of the plenum 3200 in use. In some forms, the plenum 3200 and the seal-forming structure 3100 are formed from a single homogeneous sheet of material.

[0270] In some forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with therapy.

[0271] In some forms of the present technology, the plenum chamber 3200 is constructed of a transparent material (e.g., transparent polycarbonate). The use of a transparent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy. The use of a transparent material can help the clinician observe how the patient interface is positioned and functioning.

[0272] In some forms of the present technology, the pneumatic 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.

[0273] In some forms, the plenum 3200 is constructed of a rigid material such as polycarbonate. The rigid material can provide support for the seal-forming structure.

[0274] In some forms, the plenum 3200 is comprised of a flexible material (e.g., comprised of a soft, flexible, resilient material such as silicone, fabric, foam, etc.). For example, in an example, it may be formed of a material having a Young's modulus of 0.4 GPa or less, such as foam. In some forms of the present technology, the plenum 3200 may be made of a material having a Young's modulus of 0.1 GPa or less, such as rubber. In other forms of the present technology, the plenum 3200 may be made of a material having a Young's modulus of 0.7 MPa or less (e.g., between 0.7 MPa and 0.3 MPa). An example of such a material is silicone.

[0275] 5.3.1.1 Multiple openings

[0276] like Figure 4A and Figure 4B As shown, the different plenum chambers 3200-1, 3200-2 may be formed as part of a multi-opening cushion 3050-1, 3050-2. In the example shown, the cushions 3050-1, 3050-2 each include three openings, but alternative cushions may be formed with more or fewer openings.

[0277] In some forms, different openings may serve different functions. For example, some openings may be inlet openings only, while other openings may be outlet openings only.

[0278] In other forms, at least one opening can provide two different functions. For example, during the same breathing cycle, one opening can be used as an inlet and an outlet.

[0279] The multiple openings can allow for multiple configurations of air delivery to the plenum chambers 3200-1, 3200-2. For example, a patient can use a given cushion 3050-1, 3050-2 in an "up tube" configuration (e.g., using a catheter headgear - described below) or a "down tube" configuration (e.g., using a single catheter in front of the patient's face), depending on the patient's needs and / or the patient's comfort.

[0280] 5.3.1.1.1 Oronasal mask

[0281] like Figure 4A As shown, the plenum 3200-1 includes a pair of plenum inlet ports 3254-1 that can be used to deliver gas into and / or out of the plenum 3200-1. The plenum inlets 3254-1 can be disposed on opposite sides (eg, left and right sides) of the plenum 3200-1.

[0282] In some forms, the plenum 3200-1 may also include at least one vent 3402-1 (see e.g. Figure 4AThe vent opening 3402-1 may be disposed at the center of the plenum 3200-1. For example, the vent 3402-1 may be disposed between the plenum inlets 3254-1.

[0283] In some forms, the plenum 3200-1 may include a pair of grooves 3266-1. Each groove 3266-1 may be disposed proximate one of the plenum inlets 3254-1. Each groove 3266-1 may form a partially recessed surface.

[0284] 5.3.1.1.2 Nasal mask only

[0285] Only the plenum chamber 3200-2 of the nasal cushion 3050-2 may be similar to the plenum chamber 3200-1 of the oral-nasal cushion 3050-1. Only some of the similarities and differences between the plenum chambers 3200-1, 3200-2 are described below.

[0286] like Figure 4B As shown, the plenum 3200-2 includes a pair of plenum inlet ports 3254-2 that can be used to deliver gas into and / or out of the plenum 3200-2. The plenum inlets 3254-2 can be disposed on opposite sides (eg, left and right sides) of the plenum 3200-2.

[0287] In some forms, the plenum 3200-2 may also include at least one vent 3402-2 (see, e.g., Figure 4B The vent opening 3402-2 may be disposed at the center of the plenum 3200-2. For example, the vent 3402-2 may be disposed between the plenum inlets 3254-2.

[0288] In some forms, the plenum 3200-2 may include a pair of grooves 3266-2. Each groove 3266-2 may be disposed adjacent one of the plenum inlets 3254-2. Each groove 3266-2 may form a partially recessed surface.

[0289] 5.3.2 Positioning and stabilizing the structure

[0290] In one form, the positioning and stabilising structure 3300 provides a retaining force as a safety margin to overcome the potential effects of disturbing forces on the patient interface 3000, such as from tube resistance or accidental disturbances to the patient interface.

[0291] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to conform to the manner in which it is worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a small profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilizing structure 3300 includes at least one band that is rectangular in cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat band.

[0292] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is constructed so as not to be too large and bulky to prevent a patient from lying in a supine sleeping position with the back of the patient's head on a pillow.

[0293] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is constructed so as not to be too large and bulky to prevent a patient from lying in a side-lying sleeping position with the side area of ​​the patient's head on a pillow.

[0294] In one form of the present technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front portion of the positioning and stabilizing structure 3300 and the back portion of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and may be, for example, a flexible or soft band. The decoupling portion is constructed and arranged such that when the patient lies with their head on the pillow, the presence of the decoupling portion prevents forces on the back portion from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0295] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a belt 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 belt. In one form, the fabric outer layer comprises a loop material partially engaged with a hook material.

[0296] In some forms of the present technology, the positioning and stabilizing structure 3300 includes an extendable strap, such as a resiliently extendable strap. For example, the strap can be configured to be in tension during use and to direct a force to bring the seal-forming structure into sealing contact with a portion of the patient's face. In an example, the strap can be configured as a tie.

[0297] In one form of the present technology, the positioning and stabilising structure comprises a first strap constructed and arranged such that in use at least a portion of its lower edge passes through a supraauricular base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0298] In one form of the present technology applicable to a purely nasal mask or to a full-face mask, the positioning and stabilizing structure includes a second strap, which is constructed and arranged so that in use, at least a portion of its upper edge passes below the subauricular base point of the patient's head and covers the occipital bone of the patient's head or is located below the occipital bone of the patient's head.

[0299] In one form of the present technology applicable to a nasal-only mask or to a full-face mask, the positioning and stabilizing structure includes a 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.

[0300] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a bendable and, for example, non-rigid belt. An advantage of this aspect is that the belt is more comfortable for the patient when the patient is sleeping.

[0301] In some forms of the present technology, the positioning and stabilising structure 3300 comprises a belt that is configured to be breathable to allow moisture vapor to be transmitted through the belt.

[0302] 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 corresponding to a different range of sizes and / or shapes. For example, the system may include one form of the positioning and stabilizing structure 3300 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.

[0303] 5.3.2.1 Catheter head cover

[0304] 5.3.2.1.1 Catheter head sleeve

[0305] In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more head cuffs 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, such as through the pneumatic chamber 3200 and the seal-forming structure 3100. Figure 4J In the form of the present technology shown, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the plenum chamber 3200. The tubes 3350 are configured to position and stabilize the seal-forming structure 3100 of the patient interface 3000 at an appropriate portion of the patient's face (e.g., nose and / or mouth) during use. This allows the conduit of the air circuit 4170 that provides the pressurized air flow to be connected to the connection port 3600 of the patient interface, which is located other than at the front of the patient's face, such as at the top of the patient's head.

[0306] exist Figure 4J In the form of the present technology shown, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 is positioned on a different side of the patient's head in use and extends through the corresponding cheek area, above the corresponding ear (above the supraauricular base of the patient's head) to an elbow 3610 on the top of the head of the patient 1000. This form of technology may be advantageous because if the patient sleeps with their head on their side, and one of the tubes 3350 is in a compressed state to block or partially block the flow of gas along the tube 3350, the other tube 3350 remains open to supply pressurized gas to the patient. In other examples of the technology, the patient interface 3000 may include a different number of tubes, such as one tube, or two or more tubes.

[0307] In one example where the patient interface has one tube 3350, the single tube 3350 is positioned on one side of the patient's head (e.g. across one cheek region) in use, and the strap forms part of the positioning and stabilising structure 3300 and is positioned on the other side of the patient's head (e.g. across the other region) in use to help secure the patient interface 3000 to the patient's head. For example, the tube 3350 and strap may each be under tension in use to help maintain the seal-forming structure 3100 in a sealing position.

[0308] In one form, the tube 3350 can be at least partially extendable so that the tube 3350 and the belt can be adjusted to substantially equal lengths when worn by a patient. This can allow substantially symmetrical adjustment between the tube 3350 and the belt so that the seal-forming structure remains substantially in the middle.

[0309] exist Figure 4J In the form of the technology shown, two tubes 3350 are fluidly connected to each other and to a connection port 3600 at the upper end. In some instances, the two tubes 3350 are formed integrally, while in other instances, the tubes 3350 are formed separately, but are connected in use and can be separated, such as for cleaning or storage. In the case of using separate tubes, they can be indirectly connected together, for example, each can be connected to a T-shaped connector. The T-shaped connector may have two arms / branches, each arm / branch can be fluidly connected to a corresponding one of the tubes 3350. In addition, the T-shaped connector may have a third arm or opening, which provides a connection port 3600 for fluid connection to the air circuit 4170 in use. The opening can be an inlet 3332 for receiving a pressurized air flow (see, for example, 4C).

[0310] In some forms, the third arm of the T-connector may be substantially perpendicular to each of the first two arms.

[0311] In some forms, the third arm of the T-shaped connector may be formed obliquely relative to each of the first two arms.

[0312] In some forms, a Y-shaped connector may be used instead of a T-shaped connector. The first two arms may be angled relative to each other, and the third arm may be angled relative to the first two arms. The angled formation of the first two arms may resemble the shape of the patient's head so as to conform to that shape.

[0313] In some forms, at least one arm of the T-shaped connector (or Y-shaped connector) can be flexible. This can allow the connector to bend based on the shape of the patient's head and / or the forces in the positioning and stabilizing structure 3300.

[0314] In some forms, at least one arm of a T-shaped connector (or Y-shaped connector) may be at least partially rigidified. This helps maintain the shape of the connector so that a bend in the connector does not close off the airflow path.

[0315] Tube 3350 can be formed of a flexible material, such as an elastomer, for example, silicone or TPE, and / or formed of one or more textile and / or foam materials. Tube 3350 can have a preformed shape and can bend or move into another shape when a force is applied, but can return to the original preformed shape when the force is absent. The shape of tube 3350 can be generally arcuate or curved, with a shape that approximates the contour of the patient's head between the top of the head and the nose or mouth area.

[0316] In some examples, the one or more tubes 3350 are crush resistant to resist becoming blocked if crushed during use (e.g., if pressed between a patient's head and a pillow, especially if there is only one tube 3350). The tube 3350 can be formed with sufficient structural rigidity to resist crushing, or can be as described in U.S. Pat. No. 6,044,844, the contents of which are incorporated herein by reference.

[0317] Each tube 3350 can be configured to receive air flow from a connection port 3600 on the top of the patient's head and deliver the air flow to the seal-forming structure 3100 at the entrance of the patient's airway. Figure 4JIn the example shown, each tube 3350 is located on a path extending from the plenum chamber 3200 through the patient's cheek area and above the patient's ear to the curved tube 3610. For example, the portion of each tube 3350 near the plenum chamber 3200 can cover the maxillary region of the patient's head during use. Another portion of each tube 3350 can cover an area of ​​the patient's head that is above the supra-auricular base of the patient's head. Each of the tubes 3350 can also be located on either or both of the patient's sphenoid and / or temporal bones and the patient's frontal and parietal bones. The curved tube 3610 can be located on the patient's parietal bone, on the frontal bone, and / or on the junction between them (e.g., the coronal suture) during use.

[0318] In certain forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned in a range of positions across the top of the patient's head so that the patient interface 3000 can be positioned to suit the comfort or fit of an individual patient. In some instances, the headcuff 3350 is configured to allow an upper portion of the patient interface 3000 (e.g., the connection port 3600) to move relative to a lower portion of the patient interface 3000 (e.g., the plenum 3200). That is, the connection port 3600 can be at least partially decoupled from the plenum 3200. In this way, the seal-forming structure 3100 can form an effective seal with the patient's face regardless of the location of the connection port 3600 on the patient's head (at least within a predetermined range of positions).

[0319] As described above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a nose pad cushion that is generally positioned under the nose and seals to the lower periphery of the nose (e.g., a cushion under the nose). The positioning and stabilizing structure 3300 including the tube 3350 can be constructed and arranged to draw the seal-forming structure 3100 into the patient's face under the nose with a sealing force vector in a posterior and superior direction (e.g., a posterior-superior direction). The sealing force vector having a posterior-superior direction can cause the seal-forming structure 3100 to form a good seal against the lower periphery of the patient's nose and forward-facing surfaces of the patient's face, such as on either side of the patient's nose and above the patient's lips.

[0320] 5.3.2.1.2 Extendable and non-extendable tube sections

[0321] In some examples of the present technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tubes 3350 may include one or more extendable tube segments, such as formed from an extendable accordion-like structure. In some forms, the patient interface 3000 may include a positioning and stabilizing structure 3300 including at least one gas delivery tube including a tube wall having an extendable accordion-like structure. Figure 4J The patient interface 3000 shown includes a tube 3350 , an upper portion of which includes extendable tube segments, each of which is in the form of an extendable accordion structure 3362 .

[0322] In some forms, the extendable accordion-like structure 3328 may be formed as a series of ridges and grooves on the surface of the tube 3350. The accordion-like structure 3328 may be biased toward a retracted position and may be moved to an extended position when the patient is in a prone position and stabilizing structure 3300. Because portions of the tube 3350 may be substantially inextensible (e.g., inextensible tube segments 3363), the accordion-like structure 3328 allows the positioning and stabilizing structure 3300 to stretch to fit heads of different sizes. This may allow a single-sized tube 3350 to be used with multiple-sized heads. For example, as a result of the accordion-like structure 3328, the positioning and stabilizing structure 3300 may be "full-sized." Alternatively, the tube 3350 may be manufactured in multiple sizes (e.g., small, medium, large). The patient may select the length that most closely fits their head, and the accordion-like structure 3328 may be adjusted slightly to fit the individual patient.

[0323] In some forms, the inlet 3332 may be disposed in the middle of the conduit 6320. For example, the tube 3350 may be symmetrical about the inlet 3332 via at least one axis.

[0324] The cross-sectional shape of the non-extensible tube segment 3363 of the tube 3350 can be circular, elliptical, oval, D-shaped, or rounded rectangular, for example, as described in U.S. Patent No. 6,044,844. A cross-sectional shape that presents a flattened surface of the tube on the side that faces and contacts other parts of the patient's face or head can be more comfortable to wear than, for example, a tube with a circular cross-section.

[0325] In some examples of the present technology, the non-extensible tube segment 3363 is connected to the plenum chamber 3200 from a low angle. The head sleeve tube 3350 can extend downward along both sides of the patient's head and then bend forward and inward to connect to the plenum chamber 3200 at the front of the patient's face. Before connecting to the plenum chamber 3200, the tube 3350 can extend to the same vertical position as the connection with the plenum chamber 3200 (or in some examples, below the connection with the plenum chamber 3200). That is, the tube 3350 can protrude in an at least partially upward direction before connecting to the plenum chamber 3200. A portion of the tube 3350 can be located below the plenum chamber 3200 and / or the seal-forming structure 3100. The tube 3350 can contact the patient's face below the patient's cheekbones, which can be more comfortable than contacting on the patient's cheekbones and can avoid excessive blurring of the patient's peripheral vision.

[0326] 5.3.2.1.3 Catheter head cover connection port

[0327] In some forms of the present technology, the patient interface 3000 may include a connection port 3600 located near the upper portion, outer portion, or rear portion of the patient's head. Figure 4J In the form of the present technology shown, the connection port 3600 is located at the top of the patient's head (e.g., in an upper position relative to the patient's head). In this example, the patient interface 3000 includes an elbow 3610 that forms the connection port 3600. The elbow 3610 can be configured to be fluidly connected to the conduit of the air circuit 4170. The elbow 3610 can be configured to rotate relative to the positioning and stabilizing structure 3300 to at least partially decouple the conduit from the positioning and stabilizing structure 3300. In some examples, the elbow 3610 can be configured to rotate by rotating around a substantially vertical axis, and in some specific examples, by rotating around two or more axes. In some examples, the elbow can include a tube 3350 or be connected to the tube 3350 by a ball joint. In use, the connection port 3600 can be located in the sagittal plane of the patient's head.

[0328] A patient interface having a connection port that is not positioned in front of the patient's face may be advantageous because some patients may find the conduit of the patient interface connected to the front of the patient's face unsightly and / or obtrusive. For example, the conduit of the patient interface connected to the front of the patient's face may be prone to conflict with bedding, particularly if the conduit extends downward from the patient interface during use. The form of the present technology including a patient interface having a connection port positioned above the patient's head during use can make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: a side-lying position, a supine position (e.g., on its back, generally facing upward) or a prone position (e.g., on its front, generally facing downward). In addition, connecting the conduit to the front portion of the patient interface may exacerbate a problem known as tube resistance, in which the conduit applies an undesirable force on the patient interface during movement of the patient's head or conduit, resulting in displacement away from the face. Tube resistance may not be a problem (wherein tube resistance may be more likely to destroy the seal) when receiving forces at a position above the patient's head rather than in front of the patient's face near the seal-forming structure.

[0329] 5.3.2.1.4 Head-sleeve fluid connection

[0330] The two tubes 3350 are fluidically connected to the pneumatic chamber 3200 at their lower ends. In some forms of the technology, the connection between the tubes 3350 and the pneumatic chamber 3200 is achieved by the connection of two rigid connectors. The tubes 3350 and the pneumatic chamber 3200 can be configured so that the patient can easily connect the two components together in a reliable manner. The tubes 3350 and the pneumatic chamber 3200 can be configured to provide tactile and / or auditory feedback in the form of a "reassuring click" or similar sound, so that the patient can easily know that each tube 3350 has been correctly connected to the pneumatic chamber 3200. In one form, the tubes 3350 are formed of silicone or a textile material, and the lower end of each silicone tube 3350 is overmolded to a rigid connector made of, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector on each tube 3350 may include a concave mating feature that is configured to connect to a convex mating feature on the pneumatic chamber 3200. Alternatively, the rigid connector on each tube 3350 may include a male mating feature configured to connect to a female mating feature on the plenum 3200. In other examples, the tubes 3350 may each include a male or female connector formed from a flexible material such as silicone or TPE, e.g., the same material from which the tubes 3350 are formed.

[0331] In other examples, compression seals are used to connect each tube 3350 to the plenum chamber 3200. For example, a resilient flexible (e.g., silicone) tube 3350 without a rigid connector can be configured to be subjected to extrusion to reduce its diameter so that it can be compressed into a port in the plenum chamber 3200, and the inherent resilience of the silicone pushes the tube 3350 outwardly so as to seal the tube 3350 in the port in an airtight manner. Alternatively, in a hard-to-hard joint between the tube 3350 and the plenum chamber 3200, each tube 3350 and / or the plenum chamber 3200 can include a pressure-activated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange can be pushed against the junction between the tube and the circumferential surface of the port or connector surrounding the plenum chamber 3200 to form or enhance the seal between the tube 3350 and the plenum chamber 3200.

[0332] 5.3.2.2 Headgear strap

[0333] In some forms, the positioning and stabilizing structure 3300 may include a headgear 3302 having at least one strap that can be worn by a patient to assist in properly orienting the seal-forming structure 3100 relative to the patient's face (eg, to limit or prevent leakage).

[0334] As described above, some forms of headgear 3302 can be constructed of a fabric material that can fit comfortably against the patient's skin. The fabric can be flexible so as to conform to various facial contours. Although the fabric can include rigid pieces along a selected length, this can limit bending, flexing, and / or stretching of the headgear 3302.

[0335] In some forms, the headgear 3302 can be at least partially extensible. For example, the headgear 3302 can include elastic or similar extensible materials. For example, the entire headgear 3302 can be extensible, or selected portions can be extensible (or more extensible than surrounding portions). This can allow the headgear 3302 to stretch under tension, which can help provide a sealing force to the seal-forming structure 3100.

[0336] Two forms of headgear, four-point headgear 3302-1 and two-point headgear 3302-2, are discussed in more detail below as illustrative examples.

[0337] 5.3.2.2.1 Four-point connection

[0338] like Figure 4EAs shown, some forms of the headgear 3302-1 may be a four-point connection headgear. This means that the headgear 3302-1 can be connected to four separate locations on the inflatable chamber 3200, to the frame of the inflatable chamber 3200, and / or to the arms of the inflatable chamber 3200. The headgear 3302-1 may include four different straps that provide tension to help hold the seal-forming structure 3100 in a sealed position.

[0339] In some forms, the headgear 3302-1 may include a lower strap 3304-1 that may be connected to a lower portion of the cushion 3050-1. The lower strap 3304-1 may extend along the patient's cheek toward a posterior region of the patient's head. For example, the lower strap 3304-1 may cover the masseter muscles on either side of the patient's face. Thus, the lower strap 3304-1 may contact the patient's head below the patient's ears. The lower strap 3304-1 may meet at the back of the patient's head and may cover the occipital bone and / or the trapezius muscles.

[0340] The headgear 3302-1 may also include an upper strap 3305-1 that may cover the temporal bones, parietal bones, and / or occipital bones. The upper strap 3305-1 may also be connected to the tube 3350 (eg, by connecting to the tab 3320).

[0341] The back strap 3307-1 may extend between the upper strap 3305-1 and the lower strap 3304-1. The lower and upper straps 3304-1, 3305-1 on a given side (e.g., left or right) may also be connected to the back strap 3307-1 adjacent to each other. Thus, the height of the back strap 3307-1 may be approximately the combined height of the lower strap 3304-1 and the upper strap 3305-1. The back strap 3307-1 may cover the occipital bone and / or the parietal bone during use. This may allow the back strap 3307-1 to help anchor the headgear 3302-1 to the patient's head.

[0342] In the example shown, the headgear 3302-1 may be formed in a generally X-shape. The lower strap 3304-1 and the upper strap 3305-1 may be connected to the rear strap 3307-1 using sewing, ultrasonic welding, or any similar process.

[0343] In some forms, the lower strap 3304-1 is connected to the magnetic member 3306-1. For example, each lower strap 3304-1 can pass through the magnetic member 3306-1 so that the length of each lower strap 3304-1 can be adjusted. The magnetic member 3306-1 can be removably connected to the magnet 3370-1 (described below) so that the lower strap 3304-1 can be disconnected from the inflatable chamber 3200, but the length of the lower strap 3304-1 can not be affected.

[0344] In some forms, the upper straps 3305-1 may be directly connected to the tabs 3320 of the tube 3350. The upper straps 3305-1 may be passed through the tabs 3320 to adjust the length and control the tension of each upper strap 3305-1.

[0345] In some forms, the headgear 3302 - 1 may be used with only the oral and nasal cushion 3050 - 1 (eg, because only the nasal cushion 3050 - 1 does not have four connection points). However, the headgear 3302 - 1 may be used interchangeably with the tube 3350 and the rigid arm 3340 .

[0346] 5.3.2.2.2 Two-point connection

[0347] like Figure 4F As shown, some versions of the headgear 3302-2 may be a two-point connection headgear, which means that the headgear 3302-2 may be connected to two separate locations.

[0348] In some forms, the headgear 3302-2 may be formed from a continuous piece of material. In other words, the headgear 3302-2 may not be formed from multiple straps that are connected (e.g., sewn) together. This may be comfortable for the patient because they will not come into contact with any seams or joints connecting different straps. In other forms, the headgear 3302-2 may be formed from multiple straps (e.g., two upper straps, a back strap, etc.) that are connected together (e.g., by sewing, ultrasonic welding, etc.).

[0349] In some forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headgear strap in addition to the tube 3350, which is used to position and stabilize the seal-forming structure 3100 at the entrance to the patient's airway. Figure 4F As shown, the patient interface 3000 includes a rear strap 3307-2 that forms part of the positioning and stabilizing structure 3300. The rear strap 3307-2 may be referred to as a rear strap or a rear headgear strap, for example. The rear strap 3307-2 may cover the temporal bone, the parietal bone and / or the occipital bone. In other examples of the present technology, one or more additional straps may be provided. For example, a patient interface 3000 with an oral and nasal cushion according to an example of the present technology may have a second lower strap that is configured to rest on the patient's head near the patient's neck and / or on the posterior surface of the patient's neck.

[0350] like Figure 4FAs shown, some forms of headgear 3302-2 can be at least partially bifurcated. For example, a rear strap 3307-2 of the headgear 3302-2 (e.g., configured to contact the back of the patient's head) can be wider than the surrounding portion of the headgear 3302-2. The middle portion 3308-2 of the rear strap 3307-2 can include a slit 3309-2. Thus, due to the slit 3309-2, the upper portion of the rear strap 3307-2 can move relative to the lower portion. This can allow the patient to have greater strap coverage over the back region of their head, which can help to better anchor the headgear 3302-2 to the patient's head because there is no lower strap (e.g., 3304-1).

[0351] In some forms, the headgear 3302 - 2 may be used only with the nasal cushion 3050 - 2 (eg, because the oronasal cushion 3050 - 1 does not have four connection points). However, the headgear 3302 - 2 may be used interchangeably with the tube 3350 and the rigid arm 3340 .

[0352] 5.3.2.3 Rigid arm

[0353] like Figure 4D As shown, the rigid arm 3340 can be an elongated rigid member that helps to maintain a cushion (e.g., an oronasal cushion 3050-1 or a nasal cushion 3050-2) in an operating position. The rigid arm 3340 can contact one side of the patient's head and provide a force to limit the seal-forming structure 3100 from sliding away from the patient's nose and / or mouth.

[0354] In some forms, the plenum chamber 3340 is constructed of a rigid material such as polycarbonate. The rigid material does not allow the rigid arms 3340 to extend.

[0355] In some forms, the rigid arm 3340 can be flexible in at least one direction. For example, the rigid arm 3340 can be flexible about its width and can be inflexible along its length. In other words, the rigid arm 3340 can bend about an axis along the width of the rigid arm 3340, but cannot bend about an axis perpendicular to the rigid arm 3340. This can allow individual patients to adjust the rigid arm 3340 to better fit their individual head.

[0356] In some forms, the rigid arm 3340 can remain in the new position after bending. This can allow the patient to adjust the shape of the rigid arm 3340 for their specific head, and then the rigid arm 3340 will maintain the desired shape when in use to enhance the patient's comfort.

[0357] In some forms, the first end 3342 of the rigid arm 3340 can be a free end, while the second end 3344 of the rigid arm 3340 (e.g., opposite the first end 3342) can be fixed. The first end 3342 can be curved to minimize sharp edges that may cause discomfort to the patient. In use, the first end 3342 can also cover the patient's head near the temporal bone. The second end 3344 can be fixed to the arm connection structure 3504.

[0358] In some forms, the arm connection structure 3504 may be similar to the tube connection structure 3500. For example, the arm connection structure 3504 and the tube connection structure 3500 may have substantially the same shape. This may allow the tube connection structure 3500 or the arm connection structure 3504 to fit into the groove (e.g., 3266-1 or 3266-2) and connect to the inflation chamber inlet 3254. The arm connection structure 3504 can be connected to the oral and nasal cushion 3050-1 or only the nasal cushion 3050-2 in substantially the same manner as the tube connection structure 3500 (e.g., via a snap fit, press fit, friction fit, etc.).

[0359] In some forms, the arm connection structure 3504 can be used as a plug for the plenum inlet port 3254 (e.g., 3254-1 and / or 3254-2). Unlike the tube 3350, the rigid arm 3340 does not deliver pressurized air to the plenum 3200. The rigid arm 3340 can be used with a "down tube" configuration, where a hose is connected to the vent opening 3402 (e.g., 3402-1 and / or 3402-2) and air is delivered into the plenum 3200 through the vent opening 3402. In this example, the air does not need to travel into or out of the plenum inlet port 3254. Therefore, the arm connection structure 3504 can form a seal with the plenum inlet port 3254 to restrict air flow into or out of the plenum 3200.

[0360] 5.3.3 Ventilation

[0361] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow washout of exhaled gases (eg, carbon dioxide).

[0362] In some forms, the ventilator 3400 is configured to allow a continuous flow of ventilation from the interior of the plenum chamber 3200 to the surrounding environment while the pressure within the plenum chamber is positive relative to the surrounding environment. The ventilator 3400 is configured so that the ventilation flow rate is of a magnitude sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure in the plenum chamber during use.

[0363] 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.

[0364] The vent 3400 may be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupled structure, such as a rotating body.

[0365] like Figure 4N As shown, a vent 3450 may be used with the patient interface 3000. The vent 3450 may have a substantially similar shape (eg, a substantially circular shape) as the vent opening 3402-1.

[0366] The vent 3450 may be connected to the mouth and nose plenum 3200-1 (e.g., Figure 4A shown) or only the nasal inflation chamber 3200-2 (e.g., Figure 4B shown).

[0367] Continue to see Figure 4A The vent 3450 may include a vent housing 3404 that may be configured to engage with the vent opening 3402. The vent housing 3404 may be constructed of a rigid material or a semi-rigid material. For example, the vent housing 3404 may be constructed of plastic, metal, or any similar material. The vent housing 3404 may increase the rigidity of the patient interface 3000 (e.g., to limit undesirable bending that may affect the position of the seal-forming structure 3100 on the patient's face).

[0368] The vent housing 3404 may include a front surface 3408, a rear surface 3412, and a recess 3416. The front surface 3408 faces away from the patient's face during use and may be positioned outside the pressurized volume of the plenum chamber 3200. The rear surface 3412 is disposed opposite the front surface 3408. In use, the rear surface 3412 may face the patient and may be disposed within the pressurized volume of the plenum chamber 3200. The recess 3416 may be formed between the front surface 3408 and the rear surface 3412. A portion of the plenum chamber 3200 may be received within the recess 3416 to hold the vent 3400 in place.

[0369] In some forms, a diffuser 3448 may be used with the ventilation housing 3404. The diffuser 3448 may help limit the decibel output from any patient interface 3000 (or any other patient interface). Specifically, the diffuser 3448 may help limit the decibel level associated with the air output (e.g., exhaled air) from the patient interface 3000, although the diffuser 3448 may limit the decibel level at any point in the patient interface.

[0370] In certain forms, the diffuser 3448 can diffuse and thereby slow exhaust gases exiting the plenum chamber 3200 and passing through the vent housing 3404. The diffuser 3448 can help avoid jetting and associated discomfort to the patient and / or bed partner (e.g., noise caused by jetting pillows, sheets, bedding, etc.).

[0371] In some forms, the diffuser may include a front surface 3456 that faces away from the patient in use. The outer diameter of the front surface 3456 may be smaller than the inner diameter of the ventilation housing 3404 proximate the front surface 3408. This may form a gap 3464 through which air may pass.

[0372] 5.3.4 Decoupling structure

[0373] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0374] 5.3.5 Modularity

[0375] As described above, the cushions, headgear, and sleeves can have different styles, which can correspond to different uses (e.g., mouth breathing, nasal breathing, etc.). The patient or clinician can select certain combinations of cushions, headgear, and sleeves to optimize the effectiveness of the treatment and / or the comfort of the individual patient. An example of such a modular design is described in PCT / SG2022 / 050777, filed on October 28, 2022, the entire contents of which are incorporated herein by reference.

[0376] In some forms, different types of cushions, headgear, and sleeves may be used interchangeably with one another to form different combinations of patient interfaces. This may be beneficial from a manufacturing perspective because fewer parts may be used to create a greater variety of patient interfaces. Additionally or alternatively, the various combinations may allow a patient to change the type of patient interface without changing each component.

[0377] Air can be delivered to the patient in one of two main ways. In one example, the patient can be delivered to the patient through a head cannula 3350 (see, e.g., Figure 4C , 4J ) receives the pressurized air flow. This can be referred to as an "over the tube" configuration, and the connection port can be positioned at the top of the patient's head. In other instances, the patient can receive the pressurized air flow through a conduit connected to the inflation chamber 3200. This can be referred to as a "down the tube" structure, in which the airflow conduit is located in front of the patient's face. Different patients are more comfortable with one type of air delivery than another (e.g., due to the patient's sleeping style). Therefore, it may be beneficial to allow a single type of patient interface to be used in either an "over the tube" or a "down the tube" configuration.

[0378] The patient interface may be part of a modular assembly having various interchangeable components that the patient and / or clinician may swap out for one or more components of a different type. The following describes various combinations that may be created by assembling different components together.

[0379] 5.3.5.1 Sleeve

[0380] In some forms, to allow for modularity, a sleeve may be used with the tube 3350 and / or the rigid arm 3340. The sleeve may at least partially surround the tube 3350 and / or the rigid arm 3340. FIG. 4G to FIG. 4I As shown, sleeves of different shapes can be used, which can correspond to different types of positioning and stabilizing structures 3300. In some forms, the configuration of the sleeve can be customized to fit the face of a specific user. For example, the sleeve can be configured in a relatively more posterior area of ​​the patient's head.

[0381] In some forms, the sleeve can be made of a comfortable material. For example, the sleeve can be made of a fabric material, a foam material, or a combination of the two. The comfortable material can contact the patient during use and can feel soft and close to the patient's skin to improve patient compliance.

[0382] The material may also be flexible to facilitate donning or doffing the sleeve from the tube 3350 or rigid arm 3340. For example, the material may allow the sleeve to bend to conform to the shape of the tube 3350 or catheter tip or rigid arm 3340, which may vary depending on the shape of an individual patient's head.

[0383] In some forms, the sleeve can also be at least partially elastic (e.g., the material can allow the sleeve to stretch). The elastic material can help the sleeve stretch to fit around the tube 3350 or rigid arm 3340. The elastic material can then return to an initial position against the tube 3350 or rigid arm 3340 to limit sliding of the sleeve during use.

[0384] As described in more detail below, some forms of sleeves may be specific to a stiffening element (e.g., tube 3350 and / or rigid arm 3340). However, sleeves may help to interchangeably connect a stiffening element with a version or style of cushion (e.g., oral-nasal cushion 3050-1, nasal cushion only 3050-2, etc.).

[0385] 5.3.5.2 Catheter sleeve

[0386] like Figure 4G As shown, one example of a sleeve is a catheter sleeve 3351, which can be used with the tube 3350 described above.

[0387] like Figure 4GAs shown, the catheter sleeve 3351 may include a Figure 4C The curved shape of the shape of the tube 3350 is shown. The flexible material used to construct the catheter sleeve 3351 can allow the catheter sleeve 3351 to be further bent to correspond to the shape of the tube 3350 (eg, when worn by a patient).

[0388] In some forms, the catheter sleeve 3351 may include a first or upper opening 3352. The upper opening 3352 may be disposed at one end of the catheter sleeve 3351. The upper opening 3352 may be the opening of a passage extending along at least a portion of the catheter sleeve 3351.

[0389] like Figure 4G As shown, some forms of the catheter sleeve 3351 may also include a lower extension 3354. The lower extension 3354 may be positioned on the end of the catheter sleeve 3351 opposite the upper opening 3352. The catheter sleeve 3351 can be customized to fit the face of a specific user. For example, the lower extension 3354 of the catheter sleeve 3351 can be configured in a relatively more posterior region or anterior region of the patient's head.

[0390] Some forms of the lower extension 3354 may include a rigid or semi-rigid piece (e.g., within the catheter sleeve 3351). The rigid or semi-rigid piece may be made of a plastic material or the like. Alternatively, the lower extension 33543354 may be hardened using a manufacturing process (e.g., suturing a hardened thread, flat knitting, using a thicker material).

[0391] like Figure 4G As shown, some versions of the lower extension 3354 can include a connection member 3356. In the example shown, the connection member 3356 can be a magnet, although in other examples, the connection member 3356 can be a different type of connector (e.g., a mechanical fastener, an adhesive, a hook and loop material, etc.). The connection member 3356 can also be located at one end of the lower extension 3354, although the connection member 3356 can also be located anywhere along the lower extension 3354.

[0392] In some forms, the connection member 3356 (eg, a magnet) can be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the catheter sleeve 3351 is connected to the tube 3350 (see, e.g., Figure 4J ), the magnet 3370-1 connected to the lower band 3304-1 can be removably connected to the connecting member 3356 to provide tension.

[0393] 5.3.5.2.1 Four-point arm sleeve

[0394] like Figure 4HAs shown, another example of a sleeve is a four point arm sleeve 3380, which can be used with the rigid arm 3340 described above.

[0395] like Figure 4H As shown, the four-point arm sleeve 3380 may include a Figure 4D The curved shape of the shape of the rigid arm 3340 is shown. The flexible material used to construct the four-point arm sleeve 3380 can allow the four-point arm sleeve 3380 to bend further to correspond to the shape of the rigid arm 3340 (eg, when worn by a patient and / or bent by a patient).

[0396] like Figure 4H As shown, some versions of the four-point arm sleeve 3380 may include a lower extension 3384. The lower extension 3384 may be located at one end of the four-point arm sleeve 3380.

[0397] In the illustrated example, the shape and / or structure of lower extension 3384 is substantially the same as the shape of lower extension 3354. For example, lower extension 3384 may be more rigid than the remainder of four-point arm sleeve 3380 (eg, due to hardening of threads or a rigid material).

[0398] like Figure 4H As shown, some versions of the lower extension 3384 can include a connection member 3386. In the illustrated example, the connection member 3386 can be a magnet, although in other examples, the connection member 3386 can be a different type of connector (e.g., a mechanical fastener, an adhesive, a hook and loop material, etc.). The connection member 3386 can also be positioned at one end of the lower extension 3384, although the connection member 3386 can also be positioned anywhere along the lower extension 3384.

[0399] In some forms, the connecting member 3386 (eg, a magnet) can be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the four-point arm sleeve 3380 is connected to the rigid arm 3340 (see, e.g., Figure 4K ), the magnet 3370-1 connected to the lower band 3304-1 can be removably connected to the connecting member 3386 to provide tension.

[0400] like Figure 4H As shown, the four point arm sleeve 3380 may include a pair of tabs 3394, which may be similar to the tabs 3320 on the tube 3350. When the patient wears the four point arm sleeve 3380, the tabs 3394 may be positioned at substantially the same location on the patient's head as the tabs 3320 are positioned when the patient wears the tube 3350.

[0401] 5.3.5.2.2 Two-point arm sleeve

[0402] like Fig. 4IAs shown, another example of a sleeve is a two-point arm sleeve 3380-1, which can be used with the rigid arm 3340 described above.

[0403] In some forms, the two point arm sleeve 3380-1 may be similar to the above-described four point arm sleeve 3380. Only some of the similarities and differences may be described below.

[0404] like Fig. 4I As shown, the two-point arm sleeve 3380-1 can include a lower opening 3388-1 located at the end of the two-point arm sleeve 3380-1. The lower opening 3388-1 can form an opening of a passage through the two-point arm sleeve 3380-1. In the example shown, the lower opening 3388-1 can open to the surface of the catheter sleeve 3380-1.

[0405] like Fig. 4I As shown, the two point arm sleeve 3380-1 may include a pair of tabs 3394-1, which may be similar to the tabs 3320 on the tube 3350. When the patient wears the two point arm sleeve 3380-1, the tabs 3394-1 may be positioned on the patient's head at substantially the same location as the tabs 3320 are positioned when the patient wears the tube 3350.

[0406] 5.3.5.3 Assembled patient interface

[0407] like Figures 4J to 4M As shown, the various elements described above can be combined into four different patient interfaces. The different patient interfaces can allow patients to use different types based on their respective comfort levels. The modularity of the different elements (e.g., the ability to be used for multiple types of patient interfaces) can simplify manufacturing and / or can allow patients to more easily switch between multiple types of patient interfaces.

[0408] 5.3.5.3.1 Oronasal mask upper tube configuration

[0409] like Figure 4J As shown in , a patient may wear a liner 3050-1 in a tubular structure having a tube 3350 and a four-point headgear 3302-1. This assembly may form a tubular oral-nasal patient interface 3000-1.

[0410] In some forms, a catheter sleeve can be used with the tube 3350 to enable the patient to experience an "over-the-tube" air delivery style with the mouth and nose cushion 3050-1. As described below, the catheter sleeve provides an additional connection location for connecting the four-point headgear 3302-1. However, other forms of connectors besides or in addition to the catheter sleeve can be used.

[0411] In the example shown, the catheter sleeve can be connected to the tube 3350 of the positioning and stabilizing structure 3300. The tube 3350 (via the catheter connection structure 3500) can be used to connect the tube 3350 to the cushion 3050-1. The catheter sleeve provides a magnet for connecting to the magnet 3370-1 of the four-point headgear 3302-1 (see, for example Figure 4E ). Alternatively, a different connection form may be used.

[0412] like Figure 4J As shown, the four-point headgear 3302-1 can be connected at four separate locations to provide tension to maintain the cushion 3050-1 in a sealing position on the patient's head.

[0413] For example, the lower strap 3304-1 can be removably connected to the magnet of the catheter sleeve (e.g., via the magnetic member 3306-1). In use, each lower strap 3304-1 can contact the patient's cheek (e.g., covering the masseter muscle). The lower strap 3304-1 can also extend below the patient's ears.

[0414] 5.3.5.3.2 Oronasal mask lower tube configuration

[0415] like Figure 4K As shown, a patient may wear the liner 3050-1 in a downward tube configuration with rigid arms 3340 and a four-point headgear 3302-1. This assembly may form a downward facing oral-nasal patient interface 3000-2.

[0416] In some forms, a catheter sleeve can be used with the rigid arm 3340 to enable the patient to experience a "down tube" air delivery style of the oral and nasal cushion 3050-1. As described below, the catheter sleeve provides an additional connection location for connecting the four-point headgear 3302-1. However, other forms of connectors besides or in addition to the catheter sleeve can be used.

[0417] In the example shown, the catheter sleeve can be connected to the rigid arm 3340 of the positioning and stabilizing structure 3300. The rigid arm 3340 can be used to connect the rigid arm 3340 to the cushion 3050-1 (via the catheter connection structure 3504). The catheter sleeve provides a magnet for connecting to the magnet 3370-1 of the four-point headgear 3302-1 (see, for example Figure 4E ). Alternatively, a different connection form may be used.

[0418] like Figure 4K As shown, the four-point headgear 3302-1 can be connected at four separate locations to provide tension to maintain the cushion 3050-1 in a sealing position on the patient's head.

[0419] For example, the lower strap 3304-1 can be removably connected to the magnet of the catheter sleeve (e.g., via the magnetic member 3306-1). In use, each lower strap 3304-1 can contact the patient's cheek (e.g., covering the masseter muscle). The lower strap 3304-1 can also extend below the patient's ears.

[0420] 5.3.5.3.3 Nasal mask upper tube configuration

[0421] like Figure 4L As shown, the patient may wear the cushion 3050-2 in an upper tube configuration with the tube 3350 and the two-point headgear 3302-2. This assembly may form an upper tube nose-only patient interface 3000-3.

[0422] The catheter sleeve can be used with the tube 3350 and can provide additional comfort to the patient. The sleeve can connect the positioning and stabilizing structure 3300 on the cushion 3050-2 without adding additional connection points. In the example shown, the tube 3350 of the positioning and stabilizing structure 3300 can be directly connected to the cushion 3050-2.

[0423] like Figure 4L As shown, a two-point headgear 3302-2 may be connected to a tab 3320 on the tube 3350 to provide tension to hold the cushion 3050-2 in a sealed position on the patient's head.

[0424] 5.3.5.3.4 Nasal mask lower tube configuration

[0425] like Figure 4M As shown, a patient may wear a cushion 3050-2 in an upper tube configuration with rigid arms 3340 and a two-point headgear 3302-2. This assembly may form a lower tube nose-only patient interface 3000-4.

[0426] The catheter sleeve can be used with the rigid arm 3340 and can provide additional comfort to the patient. The sleeve can connect the positioning and stabilizing structure 3300 on the cushion 3050-2 without adding additional connection points. In the example shown, the rigid arm 3340 of the positioning and stabilizing structure 3300 can be directly connected to the cushion 3050-2.

[0427] like Figure 4M As shown, a two-point headgear 3302-2 may be connected to a tab 3320 on the sleeve to provide tension to hold the cushion 3050-2 in a sealed position on the patient's head.

[0428] 5.3.5.3.5 Component modularity

[0429] Figure 4PHow different elements can be combined to form the four different patient interfaces described above is shown. As shown, different parts can be reused for different types of patient interfaces. This can allow for easier manufacturing and assembly because a large number of the same parts can be produced and used in multiple styles. The only part that is not used in multiple styles may be the sleeve. However, the sleeve may be easier to manufacture. Fig.4O A portion of air circuit 4170 is shown, and Figure 4N The type of patient interface can be interchangeably replaced Fig.4O The ventilation housing 3404 of the air circuit is shown in FIG.

[0430] 5.4RPT device

[0431] like FIG. 3A to FIG. 3C As shown, an RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic and / or electronic components and is configured to execute one or more algorithms 4300, such as all or part of 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.

[0432] 5.4.1 Air filter

[0433] An RPT device according to one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0434] exist Figure 3A In one form shown, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0435] exist Figure 3A In one form shown, 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 or 3800 .

[0436] 5.4.2 Muffler

[0437] An RPT device according to one form of the present technology may include a muffler 4120 or a plurality of mufflers 4120 .

[0438] In one form of the present technology (see, for example, Figure 4B ), the inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0439] 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 or 3800 .

[0440] 5.4.3 Pressure generator

[0441] 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.

[0442] The pressure generator 4140 may be under the control of the therapy device controller 4240 .

[0443] 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.

[0444] 5.4.4 Sensors

[0445] The transducer may be internal to the RPT device or external to the RPT device. An external transducer may be located, for example, on or form part of an air circuit (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.

[0446] In one form of the present technology (see e.g. Figure 4B ), one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 can be constructed and arranged to generate a signal representative of a characteristic of the air flow, such as flow, pressure, or temperature at that point in the pneumatic path.

[0447] In one form of the present technology, one or more transducers 4270 may be located proximate to the patient interface 3000 or 3800 .

[0448] In one form, the signal from transducer 4270 may be filtered, such as by low pass filtering, high pass filtering, or band pass filtering.

[0449] 5.4.5RPT sensor

[0450] 5.4.5.1 Flow sensor

[0451] 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 of Switzerland.

[0452] In one form, a signal generated by the flow sensor 4274 and representative of the flow rate is received by the central controller 4230 .

[0453] 5.4.5.2 Pressure sensor

[0454] 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 from Honeywell. An alternative suitable pressure sensor is a transducer from the NPA series from General Electric.

[0455] In one form, a signal generated by the pressure sensor 4272 and representative of the pressure is received by the central controller 4230 .

[0456] 5.4.6 Motor speed transducer

[0457] In one form of the present technology, a motor speed transducer 4276 is used to determine the rotational speed of the motor 4144 and / or blower 4142. A motor speed signal from the motor speed transducer 4276 may be provided to the therapy device controller 4240. The motor speed transducer 4276 may be, for example, a speed sensor such as a Hall effect sensor.

[0458] 5.4.7 Anti-overflow valve

[0459] like Figure 3A As shown, 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, such as toward the motor 4144.

[0460] 5.4.8 RPT device electronic components

[0461] 5.4.8.1 Power supply

[0462] The power source 4210 may be located inside or outside the outer housing 4010 of the RPT device 4000 .

[0463] In one form of the present technology, the power supply 4210 provides power only to the RPT device 4000. In another form of the present technology, the power supply 4210 provides power to both the RPT device 4000 and the humidifier 5000.

[0464] 5.4.8.2 Input device

[0465] 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 accessible via a touch screen. In one form, the buttons, switches, or dials may be physically connected to the external housing 4010, or in another form, may communicate wirelessly with a receiver electrically connected to a central controller 4230.

[0466] In one form, input device 4220 may be constructed or arranged to allow a person to select values ​​and / or menu options.

[0467] 5.4.8.3 Central Controller

[0468] In one form of the present technology, the central controller 4230 is a processor or multiple processors adapted to control the RPT device 4000. The central controller 4230 may be a processor or multiple processors adapted to control the RPT device 4000. Figure 3B shown.

[0469] Suitable processors may include x86 Intel processors, -M processor, such as the STM32 series microcontroller from STMicroelectronics. In some alternative forms of the present technology, a 32-bit RISC CPU, such as the STR9 series microcontroller from STMicroelectronics, or a 16-bit RISC CPU, such as a processor from the MSP430 family of microcontrollers manufactured by Texas Instruments, may also be suitable.

[0470] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0471] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0472] The central controller 4230 may be configured to receive input signals from one or more transducers 4270 , one or more input devices 4220 , and the humidifier 5000 .

[0473] The central controller 4230 may be configured to provide output signals to one or more of the output device 4290 , the treatment device controller 4240 , the data communication interface 4280 , and the humidifier 5000 .

[0474] In some forms of the present technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 that may be implemented with processor control instructions represented as a computer program 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 methods may be performed by a remotely located device. For example, the remotely located device may determine a control setting for the ventilator or detect a breathing-related event by analyzing data stored, such as from any of the sensors described herein.

[0475] 5.4.8.4 Clock

[0476] The RPT device 4000 may include a clock 4232 connected to a central controller 4230 .

[0477] 5.4.8.5 Treatment device controller

[0478] In one form of the present technology, the treatment device controller 4240 is a treatment control module 4330 that forms part of the algorithm 4300 executed by the central controller 4230.

[0479] 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.

[0480] 5.4.8.6 Protection circuit

[0481] One or more protection circuits 4250 in accordance with the present technology may include electronic protection circuits, temperature and / or pressure safety circuits.

[0482] 5.4.8.7 Memory

[0483] 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.

[0484] Memory 4260 may be located on PCBA 4202. Memory 4260 may be in the form of EEPROM or NAND flash memory.

[0485] Additionally or alternatively, the RPT device 4000 includes memory 4260 in a removable form, such as a memory card manufactured in accordance with the Secure Digital (SD) standard.

[0486] In one form of the present technology, the memory 4260 is used as a non-transitory computer-readable storage medium on which are stored computer program instructions representing one or more methods described herein, such as one or more algorithms 4300.

[0487] 5.4.8.8 Data Communication System

[0488] In one form of the present technology, a data communication interface 4280 is provided and connected to a central controller 4230 (see Figure 3B ). 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.

[0489] 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.

[0490] In one form, remote external communication network 4282 is the Internet. Data communication interface 4280 may connect to the Internet using wired communication (eg, via Ethernet or fiber optic) or wireless protocols (eg, CDMA, GSM, LTE).

[0491] In one form, the local external communications network 4284 utilizes one or more communications standards, such as Bluetooth or consumer infrared protocols.

[0492] In one form, the remote external device 4286 is one or more computers, such as a cluster of networked computers. In one form, the remote external device 4286 can be a virtual computer rather than a physical computer. In either case, this remote external device 4286 can be accessed by a properly authorized person (such as a clinician).

[0493] The local external device 4288 may be a personal computer, a mobile phone, a tablet or a remote control.

[0494] 5.4.8.9 Output devices including optional displays and alarms

[0495] 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.

[0496] 5.4.8.9.1 Display Driver

[0497] 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.

[0498] 5.4.8.9.2 Display

[0499] 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 numeral "0") into eight logic signals indicating whether the eight corresponding segments are to be activated to display the particular character or symbol.

[0500] Reference now FIG. 3A to FIG. 3C In some forms of the present technology, the central controller 4230 may be configured to implement one or more algorithms 4300 represented as computer programs stored in a non-transitory computer readable storage medium, such as memory 4260. The algorithms 4300 are generally grouped into groups called modules.

[0501] In other forms of the present technology, some or all of the algorithm 4300 may be implemented by a controller of an external device, such as a local external device 4288 or a remote external device 4286. In such forms, data representing input signals and / or intermediate algorithm outputs required for the portion of the algorithm 4300 to be executed at the external device may be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In such forms, the portion of the algorithm 4300 to be executed at the external device may be represented as a computer program, such as having processor control instructions to be executed by one or more processors, stored in a non-transitory computer-readable storage medium accessible by the controller of the external device. Such a program constructs the controller of the external device to execute the portion of the algorithm 4300.

[0502] In such a form, treatment parameters generated by the external device via the treatment engine module 4320 (if so forming part of the algorithm 4300 executed by the external device) may be transmitted to the central controller 4230 to be passed to the treatment control module 4330 .

[0503] 5.4.8.10 Preprocessing Module

[0504] A pre-processing module 4310 according to one form of the present technology receives as input a signal from a transducer 4270 (e.g., a flow sensor 4274 or a pressure sensor 4272) and performs one or more processing steps to calculate one or more output values ​​to be used as input to another module (e.g., a treatment engine module 4320).

[0505] In one form of the present technology, the output values ​​include interface pressure Pm, ventilation flow rate Qv, respiratory flow rate Qr and leak flow rate Ql.

[0506] In various implementations of the present technology, the pre-processing module 4310 includes one or more of the following algorithms: an interface pressure estimation algorithm 4312 , a ventilation flow estimation algorithm 4314 , a leak flow estimation algorithm 4316 , and a respiratory flow estimation algorithm 4318 .

[0507] 5.4.8.10.1 Interface pressure estimation

[0508] In one form of the present technology, the interface pressure estimation algorithm 4312 receives as input a signal from the pressure sensor 4272 representing the pressure in the pneumatic path near the pneumatic block outlet (device pressure Pd) and a signal from the flow rate sensor 4274 representing the flow rate of the gas flow leaving the RPT device 4000 (device flow rate Qd). The device flow rate Qd without any supplemental gas 4180 can be used as the total flow rate Qt. The interface pressure estimation algorithm 4312 estimates the pressure drop ΔP through the air circuit 4170. The dependence of the pressure drop ΔP on the total flow Qt can be modeled for a particular air circuit 4170 by the pressure drop characteristic ΔP(Q). The interface pressure estimation algorithm 4312 then provides as output an estimated pressure Pm in the patient interface 3000 or 3800. The pressure Pm in the patient interface 3000 or 3800 can be estimated as the device pressure Pd minus the air circuit pressure drop ΔP.

[0509] 5.4.8.10.2 Ventilation flow rate estimation

[0510] In one form of the present technology, the ventilation flow estimation algorithm 4314 receives as input the estimated pressure Pm in the patient interface 3000 or 3800 from the interface pressure estimation algorithm 4312, and estimates the ventilation flow Qv of air from the ventilator 3400 in the patient interface 3000 or 3800. For the particular ventilator 3400 in use, the dependence of the ventilation flow rate Qv on the interface pressure Pm can be modeled by the ventilation characteristic Qv(Pm).

[0511] 5.4.8.10.3 Leakage flow rate estimation

[0512] In one form of the present technology, the leak flow estimation algorithm 4316 receives the total flow Qt and the ventilation flow Qv as inputs and provides an estimate of the leak flow Ql as output. In one form, the leak flow estimation algorithm estimates the leak flow Ql by averaging the difference between the total flow Qt and the ventilation flow Qv over a sufficiently long period of time (e.g., approximately 10 seconds).

[0513] In one form, the leak flow estimation algorithm 4316 receives the total flow Qt, ventilation flow Qv and estimated pressure Pm in the patient interface 3000 or 3800 as inputs, and provides a leak flow Ql as an output, by calculating the leak conductance, and determining the leak flow Ql as a function of the leak conductance and the pressure Pm. The leak conductance is calculated as the quotient of the low-pass filtered non-ventilation flow equal to the difference between the total flow Qt and the ventilation flow Qv and the low-pass filtered pressure square root Pm, where the low-pass filter time constant has a value long enough to include several breathing cycles, for example, about 10 seconds. The leak flow Ql can be estimated as the product of the leak conductance and the pressure function Pm.

[0514] 5.4.8.10.4 Respiratory flow rate estimation

[0515] In one form of the present technology, the respiratory flow estimation algorithm 4318 receives as input the total flow Qt, the ventilation flow Qv and the leak flow Ql and estimates the respiratory flow Qr of air to the patient by subtracting the ventilation flow Qv and the leak flow Ql from the total flow Qt.

[0516] 5.4.8.11 Treatment Engine Module

[0517] In one form of the present technology, therapy engine module 4320 receives as input one or more of pressure Pm in patient interface 3000 or 3800 and respiratory flow Qr of air to the patient, and provides as output one or more therapy parameters.

[0518] In one form of the present technology, the treatment parameter is treatment pressure Pt.

[0519] In one form of the present technology, the therapy parameter is one or more of pressure amplitude, basal pressure, and target ventilation.

[0520] In various forms, the therapy engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow limitation determination 4324, apnea / hypopnea determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328 and therapy parameter determination 4329.

[0521] 5.4.8.11.1 Phase determination

[0522] In one form of the present technology, the RPT device 4000 is phase indeterminate.

[0523] In one form of the present technology, the phase determination algorithm 4321 receives as input a signal indicative of respiratory flow Qr and provides as output the phase of the current respiratory cycle of the patient 1000.

[0524] 5.4.8.11.2 Waveform determination

[0525] In one form of the present technology, the therapy parameter determination algorithm 4329 provides an approximately constant therapy pressure throughout the patient's breathing cycle.

[0526] In other forms of the present technology, the therapy control module 4330 controls the pressure generator 4140 to provide a therapy pressure Pt that varies as a function of the phase Φ of the patient's respiratory cycle according to a waveform template Π(Φ).

[0527] In one form of the present technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ) with values ​​in the range [0, 1] on the phase value Φ domain provided by the phase determination algorithm 4321 for use by the treatment parameter determination algorithm 4329.

[0528] 5.4.8.11.3 Determination of ventilation volume

[0529] In one form of the present technology, a ventilation determination algorithm 4323 receives an input of respiratory flow Qr and determines a measure indicative of current patient ventilation Vent.

[0530] 5.4.8.11.4 Determination of inspiratory flow limitation

[0531] In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 for determining the degree of inspiratory flow limitation.

[0532] 5.4.8.11.5 Determination of apnea and hypopnea

[0533] In one form of the present technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 for determining the presence of apnea and / or hypopnea.

[0534] 5.4.8.11.6 Snoring Determination

[0535] In one form of the present technology, the central controller 4230 executes one or more snoring determination algorithms 4326 for determining the level of snoring.

[0536] 5.4.8.11.7 Determination of airway patency

[0537] In one form of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 for determining the degree of airway patency.

[0538] 5.4.8.11.8 Determination of target ventilation

[0539] In one form of the present technology, the central controller 4230 takes as input a measurement of current ventilation Vent and executes one or more target ventilation determination algorithms 4328 for determining a target value Vtgt for the ventilation measurement.

[0540] 5.4.8.11.9 Determination of treatment parameters

[0541] In some forms of the present technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 for determining one or more treatment parameters using values ​​returned by one or more other algorithms in the treatment engine module 4320.

[0542] 5.4.8.12 Treatment Control Module

[0543] The therapy control module 4330 according to one aspect of the present technology receives as input therapy parameters from the therapy parameter determination algorithm 4329 of the therapy engine module 4320 and controls the pressure generator 4140 to deliver air flow according to the therapy parameters.

[0544] In one form of the present technology, the therapy parameter is a therapy pressure Pt and the therapy control module 4330 controls the pressure generator 4140 to deliver an air flow having an interface pressure Pm at the patient interface 3000 or 3800 equal to the therapy pressure Pt.

[0545] 5.4.8.13 Detection of fault conditions

[0546] In one form of the present technology, the central controller 4230 executes one or more methods 4340 for detecting a fault condition. The fault condition detected by the one or more methods 4340 may include at least one of the following:

[0547] Power failure (no power or insufficient power)

[0548] Sensor fault detection

[0549] Unable to detect the presence of parts

[0550] Operating parameters outside recommended ranges (e.g., pressure, flow rate, temperature, PaO2)

[0551] The test alarm fails to generate a detectable alarm signal.

[0552] When a fault condition is detected, the corresponding algorithm signals the presence of a fault by one or more of the following:

[0553] Activate audible, visual and / or dynamic (e.g. vibration) alarms

[0554] Send messages to external devices

[0555] Event log

[0556] 5.5 Patient interface testing

[0557] Figure 5A A schematic diagram of a respiratory therapy system 8000 is shown. The respiratory therapy system 8000 can be configured to wirelessly detect information about a patient interface 3000 or an accessory used by a patient during a therapy session. In some aspects, incorporation of the techniques described further below can create a patient interface (or accessory) detection system in which the patient need not manually scan or enter (e.g., via an external device such as a smart phone, computer, or tablet, or via a mechanism within the respiratory therapy system) the type of patient interface being used. In other aspects, incorporation of a wireless patient interface detection system can allow the respiratory therapy system 8000 to confirm the accuracy of patient input regarding the type of patient interface (or accessory) being used, or can track usage or other characteristics of the patient interface (or accessory) being used, as described further below.

[0558] Respiratory therapy system 8000 includes a patient interface 3000 and a respiratory pressure therapy (RPT) device 4000 fluidly coupled via an air circuit 4170, which may be a conduit or tube, as described above. As described above, RPT device 4000 is configured to supply a flow of air, such as air that may be supplemented with oxygen, to patient interface 3000 via air circuit 4170. RPT device 4000 may include any of the elements described above, such as a humidifier, an oxygen source, and / or a data management system.

[0559] The RPT device 4000 can be used alone or as part of the system 8000 to deliver one or more of the various therapies described above, for example by operating the device to generate an airflow for delivery to an interface (e.g., patient interface 3000) to the airway of a user. The air flow can be pressure controlled (for respiratory pressure therapy) or flow controlled (for flow therapy such as HFT). Thus, the RPT device 4000 can also be used as a flow therapy device. The RPT device 4000 can include, for example, a CPAP device and / or a ventilator.

[0560] The respiratory therapy system 8000 may also include a radio frequency identification (RFID) system 9000. The RFID system 9000 may, for example, be configured to detect one or more characteristics of the respiratory therapy delivered from the RPT device 4000 to the patient interface 3000, an identification of the patient interface 3000, and / or an identification of an accessory device (not shown) coupled directly or indirectly to the respiratory therapy system 8000. Exemplary accessory devices may include, but are not limited to, a patient interface headgear, a cushion on the patient interface 3000, an air filter, a humidifier, one or more components of a humidification system (e.g., a heat and moisture exchanger or a component of a waterless humidifier), a catheter, and / or an adapter attachment.

[0561] RFID is a form of wireless communication that incorporates the use of electromagnetic or electrostatic coupling in the radio frequency portion of the electromagnetic spectrum to, for example, uniquely identify and / or track objects. RFID system 9000 may operate according to the principles of inductive coupling.

[0562] RFID system 9000 includes a transponder 9200 (hereinafter referred to as a "tag"), a transceiver 9300, and an antenna 9100. In some embodiments, RFID system 9000 includes one antenna 9100. In alternative embodiments, as described in further detail herein, RFID system 9000 includes two or more antennas 9100. Antenna 9100 is configured to transmit radio waves and receive, for example, reflected signals from tag 9200. Antenna 9100 can be a linear antenna and can therefore transmit linearly polarized signals, or antenna 9100 can be a circular antenna and can therefore transmit circularly polarized signals. In some embodiments, RFID system 9000 can include a linear antenna and a circular antenna.

[0563] The antenna 9100 may be disposed within a proximal portion of the air circuit 4170 (e.g., near the patient interface 3000). For example, the antenna 9100 may be disposed within a portion of the air circuit 4170, such as within a cover 4172 on the proximal portion 4170A of the air circuit 4170, such as Fig. 6A and Figure 6B In an alternative embodiment, the antenna 9100 may be disposed in the lumen 4178 of the air circuit 4170 (see Fig. 6A and Figure 6B In another optional configuration, the antenna 9100 can be fixedly or removably coupled to the outside of the air loop 4170, such as on an outer surface of the air loop 4170.

[0564] The tag 9200 is configured to emit radio waves to send information. The tag 9200 may contain a microchip that stores and processes information, such as a unique identifier of the tag 9200 and an antenna 9100 to enable the tag 9200 to receive and / or transmit radio signals. The tag 9200 may be an active tag or a passive tag. If a passive tag is used, it may rely on the power of the antenna to send data and may therefore have a shorter transmission range. For example, the tag 9200 may receive all the energy it needs from the magnetic field in which the tag 9200 operates.

[0565] The label 9200 can be read-only, read / write, or write once and read multiple times. The label 9200 can be configured to include identification data of the patient interface 3000 and / or the patient. In some aspects, the label 9200 may include information related to the date of use or a timestamp. The label 9200 may additionally or alternatively include information related to the type of patient interface 3000 used, the characteristics of the patient interface 3000 (e.g., one or more of the cushion material, cushion size, catheter size, patient interface size, length of use of the patient interface, date of manufacture of the patient interface, a group of respiratory treatment conditions that the patient interface is suitable for use with it, etc.), the serial identification number of the patient interface 3000, the production batch identification number of the patient interface 3000, and / or other aspects of the respiratory therapy system 8000. In some aspects, the label 9200 can be configured to include patient information, such as the type of treatment or treatment setting that the patient wants to receive, or other information. The label 9200 can also be used to detect the connection and / or disconnection of the air circuit 4170 and / or an accessory device (not shown).

[0566] In some embodiments, the label 9200 may include an adhesive, for example, to assist in applying the label 9200 to the patient interface 3000 and / or to hold the label 9200 in place on the patient interface 3000 after application. Alternatively, the label 9200 may be overmolded within a portion of the patient interface 3000. For example, the label 9200 may be overmolded into a soft plastic material, such as a silicone liner, or overmolded into a hard plastic material, such as a plastic frame of the patient interface 3000. Alternatively, the label 9200 may include conductive silicone and / or conductive thread or ink (e.g., silver ink) printed on the soft and / or hard plastic material that constitutes the patient interface 3000. The label 9200 may include, for example, an overmolded inlay label, a conductive fabric, or may be coupled to the patient interface 3000 in any suitable manner used in the art.

[0567] The tag 9200 may be an RFID tag, and in some cases may be a near field communication (NFC) tag. The tag 9200 may be configured to generate an electromagnetic field having a frequency of about 10 MHz to about 12 GHz (e.g., about 13.56 megahertz (MHz)), and the antenna 9100 may be configured to read data sent from the tag 9200 at about 10 MHz to about 12 GHz (e.g., about 13.56 MHz). In other aspects, the RFID system 9000 may alternatively be configured to generate an electromagnetic field having a frequency between about 30 kilohertz (kHz) and about 3 gigahertz (GHz). In some instances, the RFID system 9000 may be configured to operate in a low frequency range, or operate between about 30 kHz to 300 kHz. Therefore, the RFID system 9000 may be configured to have a read range of up to about 10 centimeters (about 3.94 inches), although the exact distance may vary according to, for example, the angles of different components in the system relative to each other. Alternatively, RFID system 9000 can be configured to operate in a high frequency range, or operate between about 3MHz and 30MHz. In this configuration, RFID system 9000 can be configured to have a read range between about 10 centimeters to about one meter (about 3.94 inches to about 39.37 inches). In addition, RFID system 9000 can be configured to operate in an ultra-high frequency range, or operate between about 300MHz and 3GHz. In this configuration, RFID system 9000 can be configured to have a read range between about one meter to about 12 meters. For example, tag 9200 can be an ultra-high frequency (UHF) tag, a Bluetooth tag, or an ultra-wideband (UWB) tag. Tag 9200 and antenna 9100 can be tuned to operate on the same frequency. The UWB tag 9200 may operate at a frequency range of about 3.1 GHz to about 10.6 GHz, the Bluetooth tag 9200 may operate at a frequency of about 2.4 GHz, and the UHF tag 9200 may operate at a frequency of about 300 MHz to about 3 GHz.

[0568] In some instances, a shorter read range of the RFID system 9000 may be desirable. For example, if a patient is near multiple devices or objects that contain RFID components, the RFID system 9000 may inadvertently read a tag or antenna on a peripheral device. Therefore, if the RFID system 9000 is configured to operate at a lower frequency range, such as 13.56 MHz, the likelihood of the RFID system 9000 inadvertently reading a peripheral device is reduced.

[0569] The RFID system 9000 may include a single tag 9200 that is fixedly or removably coupled to a patient interface 3000 or an accessory device (not shown). Alternatively, the RFID system 9000 may include two or more tags 9200 that are fixedly coupled to a patient interface 3000 or an accessory device (not shown). The RFID tags 9200 described herein may be off-the-shelf components, or may be customized based on the size and / or shape of the patient interface 3000 and / or based on the read range of the tag 9200. Although the tag 9200 is described herein as being associated with a patient interface 3000, the tag 9200 may alternatively or additionally be associated with, for example, an air circuit 4170 or another accessory of the respiratory therapy system 8000. To the extent that the tag 9200 is associated with the air circuit 4170 or another accessory, the tag 9200 may include information about the accessory or air circuit with which it is associated.

[0570] The antenna 9100 is configured to receive data from the tag 9200 and transmit the received data to the transceiver or reader 9300. For different types of patient interfaces 3000, the antenna 9100 can be set to the same inductance as the tag 9200, so that the antenna 9100 can be compatible with a variety of patient interfaces 3000. The transceiver 9300 can be physically (e.g., via a wire) operably connected to the antenna 9100 and can be located on or in the air circuit 4170 or the adapter 9400. In one configuration, the transceiver 9300 can be located on or in the RPT device 4000. In one configuration, the transceiver 9300 can be external to the respiratory therapy system 8000. For example, the transceiver 9300 can be a scanner, a smart phone, a tablet computer, or any other device configured to receive an RFID signal transmitted from an RFID tag or antenna. Therefore, the antenna 9100 is configured to transmit data received from the tag 9200 to the transceiver 9300. The transceiver 9300 may also be configured to save or store data transmitted from the antenna 9100 .

[0571] Still reference Figure 5A, the transceiver 9300 may include a controller on a flexible circuit, for example, connected within the air circuit 4170. The transceiver 9300 may relay information from the antenna 9100 to a controller configured to control the RPT device 4000. The controller may be separate from the RPT device 4000, or may be part of the RPT device 4000. The controller may operate as described above. The transceiver 9300 may generate an electromagnetic field having an appropriate frequency (e.g., 13.56 MHz) and may be configured to read the tag 9200 from the patient interface 3000 or an accessory coupled to the patient interface 3000. The accessory may include, but is not limited to, one or more of a headgear, a cushion, a heat and moisture exchanger or a waterless humidifier, an air filter, an air duct, or an adapter of the patient interface, as described above.

[0572] In some configurations, the transceiver 9300 may be configured to transmit data to the RPT device 4000 either physically (e.g., via wires) or wirelessly. The RPT device 4000 may also be configured to save or store data sent from the transceiver 9300, interpret the sent data, and / or send an alert or signal to a user or care provider, as described above. In some embodiments, the RPT device 4000 may also be configured to automatically change one or more characteristics of the respiratory pressure therapy, for example, based on raw data and / or interpreted data received from the transceiver 9300. Additionally or alternatively, the RPT device 4000 may be configured to recommend one or more therapy settings, for example, to facilitate patient care and / or patient comfort based on interpreted data from the transceiver 9300, as will be discussed further below.

[0573] Figure 5B An alternative configuration of a respiratory therapy system 8000' is shown. The respiratory therapy system 8000' can include any of the features discussed above with respect to the respiratory therapy system 8000, except as described below. For example, the respiratory therapy system 8000' includes a patient interface 3000 and a respiratory pressure therapy (RPT) device 4000 fluidly coupled via an air circuit 4170. The respiratory therapy system 8000' also includes an RFID system 9000'.

[0574] Similar to the above Figure 5A The RFID system 9000 discussed, the RFID system 9000′ includes a tag 9200, an antenna 9100 and a transceiver 9300. Figure 5BIn the configuration shown in , an adapter 9400 is configured to be fixedly or removably coupled between the air circuit 4170 and the patient interface 3000. The adapter 9400 may include or contain the antenna 9100. Thus, the adapter 9400 and the antenna 9100 may be, for example, separate components independent of the air circuit 4170 and the patient interface 3000. In this way, the adapter 9400 may be used in conjunction with various air circuits 4170, or may be used to modify an air circuit 4170 without the antenna 9100. In some aspects, the adapter 9400 may be reusable, and the air circuit 4170 may be replaceable. Figure 5B The antenna shown in may have any or all of the characteristics of antenna 9100, as described above with reference to Figure 5A In some aspects of the present technology, the adapter 9400 may also include one or more sensors.

[0575] Various types of sensors The described technology uses various types of sensors. Any or all of these sensors can be configured to generate a signal based on one or more physical phenomena, indicate one or more physical phenomena, or reflect one or more physical phenomena. Illustrative examples of sensor types (and sensed physical phenomena) include humidity, temperature, airflow, pressure, light, particles, biochemistry, acceleration, angular velocity, etc. Other types of sensors are also discussed herein and can be used in conjunction with the technology described herein. Any or all sensors described herein can transmit signals based on sensed physical phenomena via wired communication and / or via wireless communication. Any or all sensors discussed herein can be included as part of adapter 9400 (e.g., as sensor 9504), which is discussed in more detail elsewhere herein. Any or all sensors described herein may be located at different locations associated with an exemplary respiratory therapy system and its components. For example, a first sensor may be located in an RPT device, another in a patient interface, and another in an air duct. Other examples of where one or more sensors can be positioned are described herein.

[0576] The adapter 9400 may be in fluid communication with the air circuit 4170 and the patient interface 3000. In this way, the adapter 9400 may include a lumen having a proximal opening and a distal opening. The lumen is configured to allow air to flow from the air circuit 4170 through the adapter 9400 into the patient interface 3000. In addition, the adapter 9400 forms a fluid seal between the air circuit 4170 and the patient interface 3000. In order to achieve a fluid tight seal, in some configurations, the proximal portion of the air circuit 4170 may extend at least partially into the distal portion of the adapter 9400, for example, through the distal opening of the adapter 9400. Alternatively, the distal portion of the adapter 9400 may extend at least partially into the proximal portion of the air circuit 4170. Similarly, the distal portion of the patient interface 3000 may extend at least partially into the proximal opening of the adapter 9400.

[0577] Fig. 6A and Figure 6B A perspective view of the proximal portion 4170A of the air circuit 4170 is shown. For example, Fig. 6A and 6B The air circuit 4170 shown can be respectively Figure 5A and 5B The air circuit 4170 is used with the system 8000 or system 8000′ shown. The air circuit 4170 is a conduit or tube constructed and arranged to allow air flow to travel between two components of the respiratory therapy system (e.g., the RPT device 4000 and the patient interface 3000) in use. Although not shown, in some cases, the branches of the air circuit 4170 for inspiration and exhalation can be separate. In other cases, the air circuit 4170 can be single-limbed and used for both inspiration and exhalation.

[0578] The proximal portion 4170A of the air circuit 4170 may include a proximal end including a cover 4172. The cover 4172 may be coupled directly or indirectly to the proximal portion 4170A of the air circuit 4170. The cover 4172 may include one or more features 4174 extending outwardly from a proximal surface 4172A of the cover 4172. The feature(s) 4174 may be configured to facilitate a secure and / or fluid-tight connection, for example, between the air circuit 4170 and the patient interface 3000 (e.g., Figure 5A ) or between the air circuit 4170 and the adapter 9400 (as shown Figure 5B). For example, feature 4174 may include a bayonet connector including protrusions and / or recesses configured to engage with corresponding protrusions and / or recesses on a patient interface / adapter by rotating the connector until it latches. In an alternative example, feature 4174 may include a tapered shape configured for connection to a patient interface / adapter. However, it should be understood that feature 4174 may include other suitable configurations (e.g., a releasable snap-fit ​​connector) to facilitate connection to a patient interface / adapter.

[0579] The cover 4172 also includes an opening 4176. The opening 4176 extends through the entire cover 4172 and is in fluid communication with the lumen 4178 of the air circuit 4170. The cover 4172 and / or the inner surface of the lumen 4178 defining the air circuit 4170 may include one or more protrusions or projections 4190. The projections 4190 may extend radially inwardly into the lumen 4178, for example, from the inner surface defining the lumen 4178 and / or from the inner surface 4179 of the cover 4172. The projections 4190 may extend partially or completely through the lumen 4178. As described below, reference Figure 6B , protrusion 4190 may include or may be mated with package 4199. Although not shown, protrusion 4190 may include one or more sensors. Sensors may be used to identify, characterize, or define various aspects of a fluid (e.g., air, gas, etc.) within air circuit 4170. For example, protrusion 4190 may include sensors to identify the temperature, humidity level, air flow, pressure, etc. of the fluid within air circuit 4170. The sensors may communicate with RPT device 4000, antenna 9100, and / or transceiver 9300.

[0580] Figure 6B A proximal portion 4170A of one version of the air circuit 4170 is shown with the cover 4172 removed. The circuit board 4192 can be disposed within the cover 4172, e.g., between an outwardly facing surface of the air circuit 4170 and an inwardly facing surface of the cover 4172. The circuit board 4192 can be configured to surround a protrusion 4170C extending proximally from a proximal-most surface 4170B of the air circuit 4170. Although not shown, the protrusion 4170C can include one or more features (e.g., one or more notches, one or more protrusions, etc.) to help support and / or restrain the circuit board 4192 in place (e.g., around the protrusion 4170C). For example, the protrusion 4170C can include a first feature (e.g., notch, protrusion) that couples the proximal portion 4192A of the circuit board 4192 to the protrusion 4170C and / or a second feature (e.g., notch, protrusion) that couples the distal portion 4192B of the circuit board 4192 to the protrusion 4170C.

[0581] The surface 4195 of the circuit board 4192 defining the platform 4196 is configured to face the proximal end. For example, the surface 4195 is configured to lie in a plane that is substantially perpendicular to an axis A extending longitudinally from the proximal end to the distal end of the air circuit 4170. In this way, the platform 4196 is bent approximately 90 degrees relative to the circuit board 4192. The platform 4196 is coupled to the circuit board 4192 via a bridge 4194. The platform 4196 also includes an antenna 4100. The antenna 4100 may have the configuration described above with reference to FIG. Figure 5A and Figure 5B The platform 4196 includes an opening 4198 extending through the entire platform 4196. The opening 4198 can be configured to allow fluid to flow through the lumen 4178 of the air circuit 4170. Thus, the opening 4198 can have the same diameter as the lumen 4178 of the air circuit 4170 or a different diameter. Although the cover 4172 is Figure 6B 4170 is removed to illustrate this exemplary arrangement of the antenna 4100 incorporated into the air circuit 4170, but during use, the cover 4172 will obscure the antenna 4100, as shown in FIG. Fig. 6A shown.

[0582] Package 4199 can house one or more sensors, such as those discussed above (e.g., the sensor in protrusion 4190). In some instances, package 4199 can be formed by additive manufacturing techniques (e.g., 3D printing). Package 4199 can be formed from any suitable material, such as a transparent material, such as silicone. Package 4199 can enclose and seal the sensor and hold the sensor in place. In an alternative, a single package 4199 can encapsulate multiple sensors. In a further alternative, proximal portion 4170A can include multiple packages 4199, each package for encapsulating one or more sensors.

[0583] Figure 6C A front view of a circuit board 4192 in a first or flat configuration is shown. Figure 6B As described above, the circuit board 4192 includes a proximal portion 4192A and a distal portion 4192B. The circuit board 4192 is configured to bend or flex around the protrusion 4170C of the air circuit 4170 (at Figure 6B ). Thus, the circuit board 4192 may be formed from one or more bendable or flexible materials.

[0584] The bridge 4194 is configured to provide a physical connection between the circuit board 4192 and the platform 4196. In order to enable the platform 4196 to be bent approximately 90 degrees, as shown in FIG. Figure 6BAs shown, bridge 4194 is formed of a bendable or flexible material. Bridge 4194 can have the same thickness as circuit board 4192 and / or platform 4196, or can have a smaller thickness than circuit board 4192 and / or platform 4196. The smaller thickness of bridge 4194 can allow bridge 4194 to bend to a greater extent and / or bend more easily. Additionally or alternatively, bridge 4194 can be made of the same material or a different material as circuit board 4192 and / or platform 4196. For example, bridge 4194 can be made of a material having more flexible properties than circuit board 4192 and / or platform 4196. When applied to air circuit 4170, opening 4198 of platform 4196 can be coaxially positioned with lumen 4178 of air circuit 4170 so that platform 4196 is located on the proximal end of protrusion 4170C. The bridge 4194 can be bent relative to the platform 4196, and the circuit board 4192 can be bent to surround the protrusion 4170C, as shown in FIG. Figure 6B shown.

[0585] The antenna 4100 is fixed to the platform 4196 and is electrically coupled to the circuit board 4192, for example, via the bridge 4194. The antenna 4100 surrounds or encircles the opening 4198. Thus, the antenna 4100 surrounds or encircles the proximal opening of the lumen 4178 of the air circuit 4170, as shown in FIG. Figure 6B shown.

[0586] Antenna 4100 can be formed by various methods or a combination of methods. Antenna 4100 may include a flexible circuit directly connected to the main flexible circuit of transceiver 9300, which may be connected to air loop 4170. Antenna 4100 may be formed by one or more conductors, such as copper, welded, soldered, glued or otherwise fixed to platform 4196 or around the periphery of air loop 4170. The wire may be fixed to the transceiver module of the circuit board. Antenna 4100 may be formed by printed conductive (e.g., silver ink or printed conductive wire) applied directly to platform 4196 or around the periphery of air loop 4170. Antenna 4100 may be formed by a flexible printed circuit (FPC), coil wire or conductive printing or plastic. Laser direct structuring (LDS) may be applied to a plastic housing that may protect electronic components. LDS may be coupled, welded or soldered to a transceiver module such as a circuit board. In this way, for example, antenna 4100 may be implemented directly on platform 4196.

[0587] The magnetic field strength of the passive tag 9200 is proportional to the distance between the passive tag 9200 and the antenna 9100. For example, when the tag 9200 moves away from the antenna 9100, the magnetic field strength of the passive RFID tag 9200 decreases. Conversely, when the tag 9200 moves closer to the antenna 9100, the magnetic field strength of the passive tag 9200 increases. This is because, as described above, the passive tags 9200 obtain the energy required to transmit radio waves from the magnetic field in which they operate. In other words, the passive tag 9200 and the antenna 9100 operate according to the principle of inductive coupling. Figure 5A and 5B The RFID system 9000 shown in FIG. 8 operates under these conditions. Therefore, the placement of the antenna 9100 relative to the tag 9200 affects the operability of the RFID system 9000 within the system 8000.

[0588] As previously discussed, the tag 9200 can be fixedly or removably coupled to the patient interface 3000, for example, near where the air circuit 4170 is coupled to the patient interface 3000. The distance between the antenna 9100 and the tag 9200 can vary depending on the type or size of the patient interface 3000 used by the patient. Figure 4J to Figure 4P As shown, as described above, the patient interface 3000 can have a variety of different configurations and various components. The type or location of the tag 9200 can be customized for different patient interface designs, for example, to fit the antenna 9100 or to place the tag 9200 in an appropriate reading direction or angle. The antenna 9100 and tag 9200 can be positioned near where the air circuit 4170 is coupled to the patient interface 3000, and can be positioned to avoid contact with the patient's skin during use, or to avoid the ventilation contact area. The system 8000 described herein can be used on a variety of patient interface types, for example, a nasal patient interface (e.g., having an upper tube) Figure 4L any of the characteristics of the patient interface 3000-3), a nasal patient interface with a lower tube (e.g., having Figure 4M any of the features of the patient interface 3000-4), a full face patient interface with an upper tube (e.g., having Figure 4J any features of the patient interface 3000-1), or a full face patient interface of the down tube (e.g. Figure 4J any features of the patient interface 3000-1), or a full face patient interface of the lower tube (e.g., having Figure 4K any characteristics of patient interface 3000-2).

[0589] Fig. 7A and Figure 7B An exemplary patient interface 3000' is depicted. For example, the patient interface 3000' can be used as described above with respect to Figure 5A and Figure 5BPatient interface 3000 of system 8000 or system 8000' is depicted. Fig. 7A is a front view of the patient interface 3000', and Figure 7B is a side view of a patient interface 3000'. The patient interface 3000' may generally be referred to as a nasal patient interface or a full-face patient interface. For example, the patient interface 3000' may be configured to cover the patient's mouth and nose, or only the patient's nose.

[0590] Fig. 7A and Figure 7B Stippling is included to better illustrate and describe the various portions of the patient interface 3000' that will be described herein. However, the stippling is for descriptive purposes and does not necessarily indicate that different portions of the patient interface 3000' include different materials, properties, or colors, although in one example, different portions may include different materials, properties, or colors.

[0591] The patient interface 3000' has a three-dimensional shape that can vary depending on the style or type of patient interface. For example, the size and shape of the patient interface 3000' can be different from that of the patient interface 3000'. Fig. 7A and Figure 7B The sizes and shapes shown vary widely. Portions of the patient interface 3000' may be formed of rigid or hard materials, while other portions of the patient interface 3000' may be formed of soft or pliable materials. Therefore, the placement of an RFID tag (e.g., tag 9200) on the patient interface 3000' presents unique considerations.

[0592] The patient interface 3000′ includes a housing 3002 having a first portion 3002A, a second portion 3002B, a third portion 3002C, and a fourth portion 3002D. One or more portions of the housing 3002 (e.g., the first portion 3002A, the second portion 3002B, and the third portion 3002C) may be formed of a rigid material (e.g., polycarbonate) and may not contact the patient's skin. One or more portions of the housing 3002 (e.g., the fourth portion 3002D) may be formed of a softer, more flexible material (e.g., silicone rubber). The first portion 3002A includes an opening 3008. The opening 3008 extends the entire thickness of the housing 3002 and is configured to couple the patient interface 3000′ directly or indirectly to the proximal portion of the air circuit 4170. The opening 3008 is aligned with the midplane M of the patient interface. The first portion 3002A surrounds the opening 3008. The second portion 3002B and the third portion 3002C surround the first portion 3002A.

[0593] Because the antenna 9100 ( Figure 6B , 6C4100) can be disposed in or on the proximal portion of the air circuit 4170, and the proximal portion of the air circuit 4170 is coupled to the patient interface 3000' via the opening 3008, so the tag 9200 can be positioned near the opening 3008 in the "down tube" configuration of the patient interface 3000', such as Fig. 7A As shown ( Figure 4K and 4M A similar "down tube" configuration is also described in which the tag 9200 may have a similar location). For example, the tag 9200 may be coupled to the first portion 3002A, the second portion 3002B, the third portion 3002C, or the fourth portion 3002D. In some aspects, due to the proximity of the opening 3008, the tag 9200 may be placed on or near the third portion 3002C, which may be an ideal positioning for the patient interface 3000'. The third portion 3002C is near or adjacent to the mid-plane M. For example, the tag 9200 may be placed to one side defined by the mid-plane M (i.e., the left side or the right side), or to the other side defined by the mid-plane M (i.e., the right side or the left side), or along the mid-plane M. In some configurations, the tag 9200 may be positioned to straddle multiple portions of the patient interface 3000'. For example, the first portion of the label 9200 may be on the first portion 3002A of the housing 3002, and the second portion of the label 9200 may be on the second portion 3002B and / or the third portion 3002C of the housing 3002. In this way, the position of the label 9200 may vary between the first portion 3002A, the second portion 3002B, the third portion 3002C, and / or the fourth portion 3002D.

[0594] The tag 9200 can be placed on or in the housing 3002 in various ways. For example, the tag 9200 can be a chip overmolded into the housing 3002. Alternatively, the tag 9200 can be directly printed on the housing 3002 by printed conductive material, such as silver ink. The tag 9200 can be an inlay tag overmolded into the housing 3002. In such an example, the tag 9200 (e.g., an inlay tag) can be inserted into a cavity of a mold for the housing 3002, for example, via automation, and the injection mold and plastic can be injected onto the inlay tag, thereby fixing the inlay tag in or on the housing 3002. Alternatively, the tag 9200 can be formed by conductive silicone and / or conductive wire printed on the housing 3002. In another alternative, the tag 9200 can be formed by a conductive fabric with a stretchable copper trace. Therefore, the tag 9200 can be formed by any of these methods or any combination of these methods, including those known in the art. Additionally, label 9200 may be a separate component secured to housing 3002 by any suitable means known in the art, including, but not limited to, adhesive and / or one or more mechanical fasteners.

[0595] The patient interface 3000' also includes a cushion 3006 configured to contact the patient's face. The cushion 3006 can be formed of a soft or pliable material, such as silicone rubber. The cushion 3006 is configured to form a seal against the patient's face. Although the label 9200 can be placed on or in the cushion 3006, it may be less desirable to place the label 9200 on or in the cushion 3006 due to challenges associated with the distance of the cushion 3006 from the opening 3008 and / or challenges associated with one or more characteristics of the material constituting the cushion 3006 (e.g., flexibility, softness, thickness, etc. of the material). Additionally or alternatively, placing the label 9200 on or in the cushion 3006, for example, between the patient's skin and the cushion 3006, may cause discomfort to the patient. That is, the label 9200 can be positioned in the cushion 3006.

[0596] although Fig. 7A and Figure 7B A down tube patient interface 3000' is depicted and the location of the tag 9200 near the opening 3008 is discussed, but an up tube patient interface may also be used in accordance with the technology. In an up tube patient interface 3000', the location of the tag 9200 may, for example, be closer to an upper region of the patient interface 3000'. In some aspects, the location of the tag 9200 on the patient interface 3000' may depend at least in part on whether the patient interface 3000' employs an up tube or down tube construction, so as to position the tag 9200 closer to the proximal portion of the air circuit 4170 and the antenna 9100 when attached to the patient interface 3000'.

[0597] Fig. 8A and Figure 8B An alternative exemplary patient interface 3000" is depicted. For example, the patient interface 3000" may be different from the above-described exemplary patient interfaces. Figure 5A and Figure 5B The described system 8000 or system 8000' is used in conjunction with each other. Fig. 8A A rear view of the patient interface 3000 is shown, and Figure 8B A top view of a patient interface 3000" is shown. The patient interface 3000' may generally be referred to as nasal pillows. For example, the patient interface 3000" may be configured to be partially inserted into a patient's nose.

[0598] Fig. 8A and Figure 8BStippling is included to better illustrate and describe the various portions of the patient interface 3000" that will be described herein. However, the stippling is for descriptive purposes and does not necessarily indicate that different portions of the patient interface 3000" include different materials, properties, or colors, although in one instance, different portions may include different materials, properties, or colors.

[0599] The patient interface 3000" has a complex three-dimensional shape. For example, the patient interface 3000" includes various curves and contours. Portions of the patient interface 3000" may be formed from soft or flexible materials, and other portions of the patient interface 3000" may be formed from hard or rigid materials. For example, the portion of the patient interface 3000" that contacts the patient's face may be soft or flexible, and the portion used to facilitate the connection between the air circuit 4170 and the patient interface 3000" may be hard or rigid. In addition, the patient interface 3000" is smaller in size than the patient interface 3000' described above. Therefore, the placement of an RFID tag, such as tag 9200, on the patient interface 3000" presents unique considerations.

[0600] The patient interface 3000" includes a first nasal cushion 3012A and a second nasal cushion 3012B on either side of a median plane M. For example, the first nasal cushion 3012A is on a first (e.g., left or right) or median plane M, and the second nasal cushion is on a second (e.g., right or left) side of the median plane M. The first nasal cushion 3012A and the second nasal cushion 3012B are configured to be at least partially inserted into the patient's nostrils and are thus skin-contacting. Therefore, the material comprising the first nasal cushion 3012A and the second nasal cushion 3012B can be soft and pliable (e.g., silicone rubber). In addition, the first nasal cushion 3012A is preferably a nasal cushion having a thickness of 0.1 mm and a width of 0.1 mm. The first and second nasal cushions 3012A and 3012B include first and second holes 3014A and 3014B extending through the entire thickness of the first and second nasal cushions 3012A and 3012B, respectively, such that the first and second nasal cushions 3012A and 3012B are fluidly connected to the lumen 3016 of the tubular portion 3018. The lumen 3016 extends through the tubular portion 3018, for example, from a first side 3020A of the tubular portion 3018 to a second side 3020B of the tubular portion 3018. The tubular portion 3018 includes a first portion 3018A, a second portion 3018B, and a third portion 3018C.

[0601] The first nasal cushion 3012A and the second nasal cushion 3012B extend radially outward from the first portion 3018A. The first portion 3018A can be composed of the same material as the first nasal cushion 3012A and the second nasal cushion 3012B or a different material. The first nasal cushion 3012A and the second nasal cushion 3012B are configured to form a seal between the patient's skin.

[0602] The second portion 3018B is located on either side of the first portion 3018A. For example, the second portion 3018B is located on the left and right sides of the first portion 3018A. The second portion 3018B can be made of the same material as the first portion 3018A, or made of a different material. The second portion 3018B is not configured to form a seal with the patient's skin and may not be configured to contact the patient's skin.

[0603] The third portion 3018C is located on the outside of each second portion 3018B. For example, the third portion 3018C is located on the left side of the first portion 3018A and on the right side of the second portion 3018B. The third portion 3018C includes a first side 3020A and a second side 3020B. The third portion 3018C may not be configured to contact the patient's skin. Therefore, the third portion 3018C may be made of a harder or more rigid material. In the patient interface 3000" of the lower tube, the air circuit 4170 may be connected to the patient interface 3000" at the first portion 3018A, which is generally opposite to the first nasal cushion 3012A and the second nasal cushion 3012B. Alternatively, in a tubular patient interface 3000", the air circuit 4170 can be attached to a catheter tip cover, which can be attached to the third portion 3018C. In some aspects, the position of the tag 9200 on the patient interface 3000" can depend at least in part on whether an over-tube or down-tube configuration is used with the patient interface 3000", so as to position the tag 9200 closer to the proximal portion of the air circuit 4170 and the antenna 9100 when attached to the patient interface 3000".

[0604] When utilizing the patient interface 3000", the air circuit 4170 having the antenna 9100 can be connected to the patient interface 3000". The tag 9200 can be located near the connection location of the air circuit 4170. For example, the tag 9200 can be coupled to the first portion 3018A, the second portion 3018B, or the third portion 3018C. In some aspects, to avoid contact with the patient's skin, the tag 9200 is coupled to the second portion 3018B or the third portion 3018C. In some configurations, the tag 9200 can be positioned to straddle multiple portions of the patient interface 3000'. For example, the first portion of the tag 9200 can be on the second portion 3018B, and the second portion of the tag 9200 can be on the third portion 3018C. In this way, the position of the tag 9200 can vary between the first portion 3018A, the second portion 3018B, and the third portion 3018C.

[0605] Placing the tag 9200 on or within the first nasal cushion 3012A, the second nasal cushion 3012B, and / or in some aspects the first portion 3018A may be less desirable due to challenges associated with contact with the patient's skin. Additional or alternative challenges may be associated with one or more properties of the materials comprising the first nasal cushion 3012A and the second nasal cushion 3012B (e.g., flexibility, softness, thickness, etc. of the materials). Additionally or alternatively, placing the tag 9200 on or within the first nasal cushion 3012A and the second nasal cushion 3012B, e.g., between the patient's skin and the first nasal cushion 3012A or the second nasal cushion 3012B, may result in patient discomfort.

[0606] The label 9200 can be placed on or in the patient interface 3000' in a variety of ways, similar to the ways in which the label 9200 is secured to the patient interface 3000' discussed above. For example, the label 9200 can be a chip overmolded within the tubular portion 3018. Alternatively, the label 9200 can be printed directly onto the tubular portion 3018 via printed conductive ink (e.g., silver ink). The label 9200 can be an inlay label overmolded within the tubular portion 3018. In such an example, the label 9200 (e.g., an inlay label) can be inserted into a cavity of a mold for the tubular portion 3018, for example, via automation, and the injection mold and plastic can be injected over the inlay label, thereby securing the inlay label within or on the tubular portion 3018. Alternatively, the label 9200 can be formed of conductive silicone and / or conductive wire printed on the tubular portion 3018. In a further alternative, the tag 9200 can be formed of a conductive fabric having a stretchable conductive (e.g., copper) trace. Thus, the tag 9200 can be formed by any one of these methods or any combination of these methods, including those known in the art. In addition, the tag 9200 can be a separate component secured to the tubular portion 3018 by various suitable means known in the art, including but not limited to adhesives and / or one or more mechanical fasteners.

[0607] During use of a patient interface 3000, 3000', 3000", or another suitable patient interface (collectively referred to as a patient interface, wherein aspects described in conjunction with patient interface 3000 may be similarly applicable to patient interface 3000' and / or 3000"), the air circuit 4170 may be fluidly coupled to the RPT device 4000 and the patient interface 3000. As described above, the RPT device 4000 may be configured to supply a flow of gas, such as air that may be supplemented with oxygen, to the patient interface 3000 via the air circuit 4170. The RPT device 4000 may also be configured to receive a signal from the RFID system 9000 once the air circuit 4170 is coupled to the patient interface 3000 (e.g., via the data communication interface 4280 and / or the central controller 4230). The signal may include information about the patient interface 3000 or an accessory. For example, antenna 9100 or adapter 9400 in air circuit 4170 may detect tag 9200 in patient interface 3000 and may read information about patient interface 3000 associated with tag 9200. For example, the information may be sent to RPT device 4000 via transceiver 9300 (e.g., to data communication interface 4280).

[0608] In some aspects, the received information can be one or more of the following: for example, the type of patient interface 3000 used, characteristics of the patient interface 3000 (e.g., one or more of cushion material, cushion size, conduit size, patient interface size, length of use of the patient interface, date of manufacture of the patient interface, a set of respiratory therapy conditions for which the patient interface is suitable for use therewith, etc.), a date of use or time stamp, a batch identification number of the patient interface 3000, or a serial number of the patient interface 3000. In some aspects, the received information can be one or more of patient information, such as the type of therapy or therapy settings that the patient wants to receive, or other information. In some aspects, the received information can be whether the air circuit 4170 and / or an accessory device (not shown) is connected or disconnected from the patient interface 3000.

[0609] The RPT device 4000 may be configured to perform an action upon receiving information about the patient interface 3000 from the RFID system 9000. For ease of description herein, the RPT device 4000 may be described as performing an action based on the receipt of information, however, this may mean that a controller incorporated as part of the RPT device 4000 (e.g., the central controller 4230 and / or the therapy control module 4330) may cause the RPT device to perform an action, or a controller separate from the RPT device 4000 may cause the RPT device 4000 to perform an action. For example, the RPT device 4000 may automatically control the operation of a therapy provided to a patient based on received information or signals (e.g., via the central controller 4230 and / or the therapy control module 4330, as described above). For example, the breathing experience may be improved by determining whether the settings of the RPT device (e.g., airflow, humidity level, etc.) are properly aligned with a patient interface worn by the patient. In some configurations, the RPT device 4000 may implement the design of patient interface-specific ventilation and flow curves to facilitate more comfortable and / or effective therapy delivery. In some aspects of the technology, an indication to the patient may be generated based on information received by the RPT device 4000. For example, an indication may be generated that the type or size of patient interface being used is incorrect, that the cushion of the patient interface or the entire patient interface should be replaced, that the RPT device 4000 is configured with one or more incorrect settings that should be changed by the patient, or other suitable indications. The indication may be generated, for example, on one or more displays of the RPT device 4000 or other components of the system 8000 to an external device, such as a remote external device 4286 or a local external device 4288 (e.g., a patient's tablet, smartphone, or computer, or a health care provider's device). In other aspects, the respiratory therapy system 8000 may receive input from the patient, for example, the patient may enter information about the patient interface 3000 during a therapy session, and the input received from the patient may be compared in the RFID system 9000 with the information received from the patient interface 3000 to confirm the accuracy of the patient's input. In some aspects, the information received from the RFID system 9000 may be used to track the use or other features of the patient interface in use.

[0610] In other aspects of the present technology, information received from the patient interface 3000 may be received by the RPT device 4000 in addition to information received from other sensors or systems associated with the system 8000 or system 8000' (collectively, the system, wherein aspects described in conjunction with the system 8000 may be similarly applied to the system 8000'). For example, a sensor or system configured to detect air flow, pressure, air leakage, humidity, or other characteristics of the system 8000 may send information to the RPT device 4000. The RPT device 4000 may analyze or interpret information about the patient interface 3000 received from the RFID system 9000, 9000' (collectively, the RFID system, wherein aspects described in conjunction with the RFID system 9000 may be similarly applied to the RFID system 9000') in conjunction with one or more other sensors. For example, information about the type or size of the patient interface being worn or how long the patient interface has been used may be received from the RFID system 9000. The system 8000 may also receive information about the occurrence of discomfort or leakage in the patient interface from other sensors or patient input.

[0611] The system 8000 can analyze this information together and can take action based on the aggregate information. For example, if patient interface discomfort is indicated by the patient or a leak is detected using the patient interface, then based on the information received from the RFID system 9000, the RPT device 4000 can generate an indication to the patient that a different size or type of patient interface should be used, a different size or type of cushion should be used, or a new patient interface or cushion should be used. The indication may include, for example, a recommendation regarding the type or size of patient interface or cushion to be used or guidance on how to select a better fitting cushion or patient interface type or size. An indication may be generated, as described above, to an external device (e.g., a remote external device 4286 or a local external device 4288 (e.g., a patient's tablet, smartphone, or computer, or a health care provider's device), for example, on one or more displays of the RPT device 4000 (e.g., display 4294) or other components of the system 8000. In other aspects, one or more settings of the RPT device 4000 may be changed based on the aggregate information received from the RFID system 9000 and other information from the system 8000. In some aspects, the indication may be that the air circuit 4170 is not coupled to the patient interface 3000 or is not properly coupled to the patient interface 3000.

[0612] In some aspects, the system 8000 can indicate to the patient when a patient interface or cushion has been worn long enough, or is a sufficiently old production batch identification number or series identification number that may affect performance, and a new patient interface or cushion should be used. In some aspects, the age of the patient interface or how many times the patient interface has been used can result in an indicator that a new patient interface or new cushion should be used. The system 8000 can instruct the patient to replace the patient interface or cushion. The indication can also depend at least in part on the recommended use period for a particular patient interface or cushion type, the type of treatment being given to the patient, or one or more other factors. Indications can be generated as described above, for example, on one or more displays of the RPT device 4000 (e.g., display 4294) or one or more displays of the system 8000, to an external device, such as a remote external device 4286 or a local external device 4288 (e.g., a patient's tablet, smartphone, or computer, or a healthcare provider's device), or to a cloud server, such as a remote external communication network 4282 and / or a local external communication network 4284 and / or a remote external communication network 4282 (e.g., for remote monitoring to improve the patient experience, trigger commands (e.g., for new patient interfaces or accessories, etc.)).

[0613] In some examples, system 8000 and / or system 8000′ may include one or more Fig.39 The external system 9520 shown may be associated with one or more Fig.39The external system 9520 shown communicates (e.g., via the Internet or other data communication network). Illustrative examples of external systems include 4286 and 4288 discussed herein. Such external computer systems can be, for example, dedicated services and / or hosted on cloud computing platforms (such as AWS, Azure, etc.). Any or all analysis, processing, operations and / or actions performed by system 8000 and / or system 8000' (discussed herein) can alternatively be performed by one or more computer systems or in conjunction with one or more computer systems. As an illustrative example, data can be received by RPT device 4000, which includes: 1) data from a tag included with a patient interface (e.g., identifying which type of patient interface is being used and / or other data as discussed herein) or other components of system 8000 or system 8000', and 2) data from sensors related to the operation of system 8000 (or 8000') (e.g., airflow, pressure, air leakage, humidity, VOC sensors, etc.). RPT device 4000 can transmit such data to one or more computer systems for processing, analysis, etc. One or more data messages may then be transmitted from the one or more computer systems back to the RPT device 4000 to perform actions such as changing or modifying its operation. The content of the data messages and / or the transmission back to the RPT device may be based on processing and / or analysis performed by the one or more computer systems. In some instances, any or all analysis or processing performed by system 8000 and / or system 8000' may be performed by a mobile device (e.g., a mobile phone or tablet) or other computing device (e.g., a desktop computer) configured to communicate with system 8000 and / or system 8000' to cause such operations or actions.

[0614] The antenna 9100 and the transceiver 9300 can read the signal from the tag 9200 at least once during the treatment session. For example, the tag 9200 can be read when the treatment starts, such as when the start button is pressed or when the automatic start is started. In some aspects, if no accessories or air circuits 4170 are detected to be attached to the patient interface 3000, the RFID system 9000 can continue to read, for example, continuously or at regular intervals. In some configurations of the technology, the signal from the tag 9200 can be read periodically, such as every few seconds, minutes, or hours. In some examples of the technology, the antenna 9100 and the transceiver 9300 can read the signal from the tag 9200 according to a regular or irregular frequency. For example, the signal can be read more or less frequently at the beginning of the session or after a predetermined amount of time. In some aspects, the frequency can be increased if an unexpected reading occurs or in the event of a reading failure. In some aspects, the type of treatment given or the type of patient interface used can at least partially determine the frequency of reading the tag 9200. In some instances, data may be acquired from the tag 9200 and / or sensor based on instructions generated or received from, for example, the RPT device 4000 and / or an external computing system hosted, for example, in a cloud computing platform. For example, the VOC sensors discussed herein may be used to acquire such data based on instructions received, for example, from a physician.

[0615] As described herein (e.g., see Figure 5B ), the RFID system may include an adapter 9400 that forms a distinct component configured to be fixedly or removably coupled between the air circuit 4170 and the patient interface 3000. The adapter 9400 may include or contain the antenna 9100, the transceiver 9300, and / or one or more sensors. In this way, the adapter 9400 may be used in conjunction with various air circuits 4170, or may be used to improve an air circuit 4170 that does not have an antenna, a transceiver, and / or one or more sensors. In some aspects, the adapter 9400 may be reusable and the air circuit 4170 may be replaceable. In an example, the antenna 9100, the transceiver 9300, and / or one or more sensors of the adapter 9400 may have any or all of the characteristics of the antenna 9100, the transceiver 9300, and / or one or more sensors described in the present application.

[0616] Figures 11 to 38 An air adapter tube 9400 (also referred to as an adapter) according to one example of the present technology is shown. As shown, the air adapter tube 9400 includes a tubular body 9410 (or lumen) configured to deliver pressurized therapeutic air between a proximal end 9420 of the tubular body and a distal end 9430 of the tubular body. The proximal end 9420 is configured to connect to a patient interface 3000 (e.g., see Figure 36 to Figure 37 ), the distal end 9430 is configured to be connected to the air delivery tube 4170 (see, for example, Figures 15 to 19 , Fig.33 and Fig.35 ). As such, the tubular body 9410 (or lumen) is configured to allow pressurized therapeutic air to flow from the air delivery tube 4170, through the adapter 9400, and into the patient interface 3000.

[0617] The tubular body 9410 includes a tube wall 9412 that forms a path for conveying air flow, one or more electrical conductors 9414 (e.g., copper or aluminum wires), and a spiral or helical rib 9416, e.g., see Fig.11 , 12 , 20, 21 and 31.

[0618] In one example, the tubular body 9410 may include a flexible material, for example, the wall 9410 may include a flexible material configured to allow the wall to flex or bend during use. In one example, the outer surface of the tubular body may include or may be covered with a textile material, for example, the wall 9410 may include or be covered with a textile material, such as Figures 11 to 19 As shown. For example, the tube wall 9410 may include a membrane covered with a textile material (e.g., including a polymer material). However, the tube wall may include other materials, such as polymers. In one example, the tube wall 9410 may include a textile material and may include a different color (e.g., blue), for example, to clearly distinguish it from the air delivery tube 4170 and / or other conduits. The tube wall 9410 may include a circular cross-section as shown, although other shapes are also possible, such as an elliptical shape. In one example, the tubular body may include an inner diameter between approximately 10-15 mm, such as 12 mm, so that the air adapter tube is flexible, soft and light to enhance the user experience. In one example, the inner diameter is at least 12 mm, such as 12-15 mm, to reduce impedance. In one example, the tubular body may include a length of about 5-15 cm, such as 8-10 cm, 8.5-10 cm, 8.5 cm. In one instance, the length is between 8.5-10 cm (e.g., at least 8.5 cm, approximately 8.5 cm), for example, such that the air adapter tube will hang vertically downward from the patient interface during use, the air adapter tube will not act like a lever arm and / or the weight of the air adapter tube will not create tube resistance that adversely affects the seal of the patient interface.

[0619] The one or more electrical conductors 9414 are configured to carry or transmit electrical signals and / or power. The one or more electrical conductors 9414 may extend throughout the length of the tubular body 9410, for example, to provide heat to the length (partially or entirely) of the air adapter tube 9400 and / or to transmit electrical signals and / or power from the proximal end 9420 to the distal end 9430 (e.g., from a sensor located in the proximal end 9420).

[0620] In one example, the tubular body 9410 may include four electrical conductors 9414, but more or less conductors are possible, such as two, three or more electrical conductors. For example, the tubular body may include two electrical conductors 9414, i.e., one conductor for power and one conductor for data / signal. In one example, if necessary, two additional wires may be provided for heating. That is, if heating of the tubular body is not provided or required, the tubular body may only include two wires for power and data / signal. In one example, each electrical conductor may include a 30AWG (American Wire Gauge) wire, but alternative wire gauges are also possible.

[0621] In one example, the spiral rib 9416 is wound helically along the length of the tube wall 9412, for example, along the outer surface of the tube wall. The spiral rib 9416 can be formed integrally with the tube wall 9412 (e.g., made of a fabric or polymer material), or can be formed separately and connected to the tube wall 9412. The spiral rib 9416 is configured to increase the rigidity of the tube wall and / or provide additional insulation. In addition, the spiral rib 9416 is configured to provide a sheath for one or more electrical conductors 9414, i.e., surround one or more electrical conductors to insulate and / or protect the electrical conductors.

[0622] The proximal end 9420 of the air adapter tube 9400 is configured to be repeatedly connected and disconnected to and from the patient interface 3000 to facilitate a releasable or detachable connection between the air adapter tube 9400 and the patient interface 3000. The proximal end 9420 is configured to form a substantially fluid-tight seal with the patient interface 3000 when the air adapter tube 9400 and the patient interface 3000 are connected to each other.

[0623] In the example shown, the proximal end 9420 includes a cuff portion 9440 (also referred to as a cuff front) and a mechanical connector (e.g., a clip member 9450) configured to connect to a patient interface. Fig. 20 and Fig.21As shown, the clip member 9450 comprises a separate and distinct structure from the collar portion 9440, i.e., the collar portion 9440 and the clip member 9450 comprise separately molded parts that are subsequently connected to one another. In the illustrated example, the clip member 9450 is configured to provide a releasable connection with the collar portion 9440, such as a releasable snap-fit ​​connection or a separable snap-fit ​​assembly.

[0624] As shown, the cuff portion 9440 includes one or more recesses 9442 configured to receive the clip member 9450, namely, an upper recess 9442U extending along the upper portion of the cuff portion 9440, the upper recess 9442U leading to a side recess 9442S on a corresponding side of the cuff portion 9440 (see, for example, Figure 20 to Figure 21 Each side recess 9442S forms a unique depression that is constructed and arranged to interact with a corresponding lug 9452 of the clip member 9450 to facilitate retaining the clip member 9450 on the collar portion 9440 (see, for example, Fig.11 ). When connected, the clip member 9450 is arranged along the outer surface of the cuff portion 9440 outside the air flow path formed by the cuff portion 9440.

[0625] The cuff portion 9440 also includes a tubular end portion 9445 that is configured to extend at least partially into the connection port 3600 of the patient interface 3000 to form a substantially fluid-tight seal with the patient interface 3000 for delivering pressurized gas (e.g., see Figure 36 to Figure 37 In an alternative embodiment, the connection port 3600 can extend at least partially into the cuff portion 9440 to form a substantially fluid-tight seal.

[0626] The clip member 9450 includes a pair of resilient quick release clip arms or clips 9454 and a connecting portion 9456 interconnecting the clip arms 9454. Each clip arm 9454 includes a snap portion 9454C and a button or finger portion 9454B. The clip arms 9454 are constructed and arranged to provide a releasable snap-fit ​​connection or a separable snap-fit ​​assembly with a patient interface, for example, the snap portion 9454C configured to deflect along the connection port 3600 of the patient interface 3000 and snap into the clip channel 3605 (see, for example, FIG. 10A ). Fig.36 ). The button portion 9454B is constructed and arranged to be manually clamped or squeezed to deflect the snap portion 9454C for separating or releasing the snap portion from the patient interface 3000 and thereby allowing the air adapter tube 9400 to be separated from the patient interface 3000 (e.g., see Fig.37). In the example shown, each snap portion 9454C includes a lead-in angle to facilitate push-in assembly, and a 90° return angle to prevent or prevent pull-out disassembly, e.g., the user must deflect the snap portion via the button portion to allow disconnection. In addition, each clip arm 9454 includes a lug 9452 to facilitate retaining the clip member 9450 on the collar portion 9440 (e.g., see Fig.11 ).

[0627] In the illustrated example, the clip member 9450 includes an open end configuration having a semi-flexible and generally semi-circular connecting portion 9456 that allows the clip member 9450 to be connected to the collar portion 9440, for example, in a manner similar to a circlip. When connected, the connecting portion 9456 of the clip member 9450 is arranged within the upper recess 9442U of the collar portion 9440 (see, for example, Fig.12 and Fig.34 ) and the clip arms 9454 are arranged along respective sides of the collar portion 9440, wherein the lugs 9452 fit into respective side recesses 9442S of the collar portion 9440 to positively and releasably interconnect the clip member 9450 and the collar portion 9440 in an assembled position (e.g., see Fig.11 ). In an alternative example, the clip member 9450 can be non-removably or permanently connected to the cuff portion 9440. In another example, the clip member and cuff portion can be integrally formed as a one-piece structure.

[0628] In one example, the connection port 3600 of the patient interface 3000 forms a clip channel 3605 (eg, via a flange along the connection port, such as Figure 36 to Figure 37 44) is configured to matingly receive the snap portions 9454C of the clip member 9450. For example, the clip channel 3605 can be configured to receive the ribs or catches of each of these snap portions 9454C so as to releasably attach the air adapter tube 9400 to the patient interface 3000 and form a rotational connection, such as allowing the air adapter tube 9400 to freely rotate 360° relative to the patient interface 3000 around the axis of the connection port 3600. The button portion 9454B can be manually clamped or squeezed to disengage the snap portions 9454C from the clip channel 3605 (e.g., see Fig.37 ).

[0629] In the example shown, Fig.363600, so that at least a radially outward surface of the tubular end portion 9445 engages the connection port 3600 to form a substantially fluid-tight seal with the patient interface 3000 for delivering pressurized gas. In one example, a front end of the tubular end portion 9445 can engage a portion of the connection port 3600 to form a seal with the connection port 3600.

[0630] In addition, the cuff portion 9440 includes one or more flanges 9446 extending radially outward (forming at least a portion of the recess 9442) that act as a stop to prevent over-insertion of the air adapter tube 9400 into the patient interface, see e.g. Fig.36 and Fig.37 .

[0631] In one example, the air adapter tube 9400 can provide decoupling of the air delivery tube 4170 from the patient interface 3000, for example, decoupling the tube resistance on the patient interface to prevent seal instability. For example, the decoupling can be provided by the clamp arm 9454, which forms a swivel connection that allows 360° free rotation of the air adapter tube 9400 (and therefore the air delivery tube 4170) relative to the patient interface 3000.

[0632] In an alternative example, instead of the clip member 9450, the mechanical connector of the air adapter tube 9400 may include an equal taper body configured to connect to the patient interface by an interference fit or a friction fit. For example, the sleeve portion 9440 of the air adapter tube may include an equal taper body configured to connect to the connection port 3600 of the patient interface 3000.

[0633] In the illustrated example, the proximal end 9420 includes one or more adapters to connect to the cuff portion 9440 and to support or house the antenna 9100, the transceiver 9300, and / or one or more sensors.

[0634] like Fig. 20 and Fig.21 As shown, the proximal end 9420 includes a first adapter element 9460 (also referred to as a pre-block or pre-block 1) and a second adapter element 9470 (also referred to as an adapter element or pre-block 2).

[0635] The first adapter element 9460 includes a main body portion 9462 and a tubular protrusion 9464 extending proximally from the main body portion 9462. The main body portion 9462 is configured to be connected to the second adapter element 9470, and the tubular protrusion 9464 is configured to support and / or hold the antenna 9100, the transceiver 9300 and / or one or more sensors.

[0636] The second adapter element 9470 is constructed and arranged to interconnect the first adapter element 9460 with the tubular wall 9410 of the tubular body. For example, the second adapter element 9470 includes a first end 9471 connected to the tubular wall 9410 and the spiral rib 9416, for example, the second adapter element 9470 is overmolded to the tubular wall 9410 (e.g., a film) and / or the spiral rib 9416 so that the second adapter element 9470 is connected and sealed to the tubular wall 9410 and / or the spiral rib 9416. The second adapter element 9470 includes a second end 9472 (opposite the first end 9471) connected to the body portion 9462 of the first adapter element 9460, for example, the second adapter element 9470 is overmolded to the first adapter element 9460. However, it should be understood that the first adapter element 9460, the second adapter element 9470, the tube wall 9410 and the spiral rib 9416 can be formed and connected to each other in other suitable ways, such as overmolding, mechanical connection, integrally formed as a single piece.

[0637] In the example shown, the transceiver 9300 is disposed on a printed circuit board (PCB) 9500. An example of the PCB 9500 is a flexible printed circuit (FPC) or a flexible circuit board 9480. Similar to the examples described herein (e.g., see Fig. 6A and Figure 6B ), the FPC 9480 includes one or more bendable or flexible materials that are constructed and arranged to allow the FPC 9480 to bend or flex around the tubular protrusion 9464 of the first adapter element 9460, for example, see Figure 20 to Figure 24 and Figures 27 to 32 .

[0638] As shown, the FPC 9480 includes a first end 9481 and a second end 9482 opposite to the first end 9481. Each of the first end 9481 and the second end 9482 includes a corresponding opening 9481o, 9482o (see, for example, Fig.32 and Fig.38 ). The FPC 9480 is configured to bend or flex around the outer cylindrical surface of the tubular protrusion 9464, and the first and second ends 9481, 9482 at least partially overlap to allow the retaining member 9465 (extending radially outward from the tubular protrusion 9464) to protrude through one or both of the corresponding openings 9481o, 9482o, thereby supporting, retaining, aligning and orienting the FPC 9480 in a proper position on the first adapter element 9460, for example, see Fig. 20 , Fig.21 and Fig.32That is, the first adapter element 9460 includes at least one feature (eg, a fastener (eg, retaining member 9465) and / or an adhesive (eg, silicone)) configured to support and retain the FPC 980.

[0639] The tubular protrusion 9464 of the first adapter element 9460 also includes at least one port 9467 that allows at least one sensor (e.g., a pressure sensor 9490) provided to the FPC 9480 to protrude radially inward into and / or through the port 9467. That is, the port 9467 allows the pressure sensor 9490 provided to the FPC 9480 to communicate with the air flow through the air adapter tube 9400. In one example, silicone can be provided to seal the sensor 9490 within the port 9467.

[0640] A sensor support 9466 is also provided to the first adapter element 9460. The sensor support 9466 extends radially inward from the tubular protrusion 9464 and includes an internal recess configured to receive a sensor (e.g., a thermistor or gas temperature sensor 9492) provided to the FPC 9480. In the example shown, the sensor support 9466 and a corresponding temperature sensor 9492 (e.g., a thermistor) are in communication with the air flow through the air adapter tube 9400, for example to measure the temperature of the air flow. In one example, the sensor support 9466 can be overmolded onto the temperature sensor 9492 of the FPC 9480.

[0641] In one example, the pressure and temperature sensed by sensors 9490, 9492 can be provided to FPC 9480. For example, an electronic circuit included in air adapter tube 9400 can be used to read data from the sensor. The data is then converted into a format by the electronic circuit and transmitted to the controller (e.g., via electrical conductor 9414 (wire) and / or antenna 9100). In one example, the sensors included in air adapter tube 9400 (e.g., including 9490, 9492) can be polled or otherwise transmitted at the same or different rates. In one example, any or all sensors of air adapter tube 9400 can be polled continuously or at a smaller (or on-demand) frequency. As an illustrative example, pressure sensor 9490 can be polled at a rate of not less than 500 Hz. The polling rate of a given sensor can be based on how the data is used. In one example, polling of some sensors included in air adapter tube 9400 can be performed at a lower frequency. For example, as an illustrative example, data from an inertial sensor can be polled once every 1 minute.

[0642] Data from the pressure and / or temperature sensed by sensors 9490, 9492 (or other sensors discussed herein) may be transmitted to another system, such as an external computer system (e.g., a cloud computing platform, a mobile device, etc.) and then processed or analyzed thereon. The results of such processing or analysis may then be transmitted back to the RPT device 4000 and / or adapter for use (e.g., to control parameters associated with therapy delivered to a patient).

[0643] In one instance, pressure data from pressure sensor 9490 (or data based thereon) may be transmitted back to the RPT device or flow generator and used to control the pressure supplied to the patient. In one instance, the data acquired by pressure sensor 9490 may be used for real-time control of the pressure generated. In one instance, the pressure value provided by pressure sensor 9490 may be used in the same or similar manner as pressure sensor 4272 discussed herein. In any instance, the pressure value provided by pressure sensor 9490 may be used to calculate Pm, or used in conjunction with interface pressure estimation algorithm 4312 discussed herein. In one instance, data from pressure sensor 9490 may be used to compensate for pneumatic errors within an air circuit (e.g., air circuit 4170).

[0644] The cuff portion 9440 is configured to connect to the first adapter element 9460. When connected, the cuff portion 9440 and the first adapter element 9460 form an annular space 9447 therebetween that is configured to receive the FPC 9480 that supports the pressure sensor 9490 and the temperature sensor 9492, see for example Fig.31 and Fig.34 .

[0645] In one example, the cuff portion 9440 can be secured to the first adapter element 9460 by ultrasonic welding. In one example, the first adapter element 9460 can include one or more energy directors (e.g., along the free end of the tubular protrusion 9464 and / or along the outer periphery of the first adapter element 9460) to facilitate the ultrasonic welding process. For example, the energy director can include a raised bead (e.g., a raised bead 9469b1 along the free end of the tubular protrusion 9464 and a raised bead 9469b2 along the outer periphery of the first adapter element 9460, such as Fig. 20 , Fig. 27 and Fig.34 ) to accelerate the formation of the joint between the cuff portion 9440 and the first adapter element 9460 during the ultrasonic welding process.

[0646] In one example, at least one vent hole 9468 can be provided along the periphery of the first adapter element 9460, see for example Fig. 20 , Fig. 22 , Fig.28 and Fig.34 As shown, the vent 9468 includes a first end 9468.1 communicating with the annular space 9447 housing the FPC 9480 and a second end 9468.2 communicating with the outside of the air adapter tube, such as the surrounding environment. In one example, the first end 9468.1 may include a larger diameter than the second end 9468.2, and the vent 9468 may include a non-linear path from the first end 9468.1 to the second end 9468.2. In one example, a waterproof pressure balancing membrane may be provided to the vent 9468, for example, on the first end 9468.1. The waterproof pressure balancing membrane may be configured to adjust the pressure difference at the proximal end 9420 (between the annular space 9447 and the surrounding environment) and prevent damage while preventing water / dust from entering the annular space of the FPC 9480. That is, the waterproof pressure balancing membrane ensures pressure balance between the annular space 9447 and the surrounding environment, so that the FPC 9480 and its sensor (e.g., pressure sensor 9490) can function reliably.

[0647] The distal end 9430 of the air adapter tube 9400 is configured to be repeatedly connected to and disconnected from the air delivery tube 4170 to facilitate a releasable or detachable connection between the air adapter tube 9400 and the air delivery tube 4170, e.g., see Figures 15 to 19 The distal end 9430 is configured to form a substantially fluid-tight seal with the air delivery tube 4170 when the air adapter tube 9400 and the air delivery tube 4170 are connected to one another.

[0648] In the example shown, the distal end 9430 includes a cuff portion 9432 and an electrical connector 9434, for example, disposed on the upper side of the cuff portion 9432. The electrical connector 9434 includes a lead frame having one or more electrical contacts 9435 (e.g., four contacts) configured to transmit power and / or signals. The electrical contacts 9435 are electrically connected to corresponding electrical conductors 9414 (wires) extending along the tubular body 9410. The electrical connector 9434 is configured to be electrically connected to a corresponding electrical connector 4175 of an air delivery tube 4170 (e.g., a heated air delivery tube).

[0649] The distal end 9430 of the air adapter tube 9400 includes a mechanical connector (e.g., a recessed side portion 9436) that is configured to mechanically connect to a corresponding mechanical connector (e.g., a pair of resilient quick release clamp arms or clips 4177) of the air delivery tube 4170. Each clamp arm 4177 includes a snap portion 4177C and a button or finger portion 4177B. The clamp arms 4177 are constructed and arranged to provide a releasable snap-fit ​​connection or a detachable snap-fit ​​assembly with the distal end 9430, for example, the snap portion 4177C is configured to deflect and snap into a corresponding one of the recessed side portions 9436, as shown in FIG. Figures 15 to 19 The button portion 4177B is constructed and arranged to be manually clamped or squeezed to deflect the snap portion 4177C for separating or releasing the snap portion from the distal end 9430 and thereby allowing the air delivery tube 4170 to be separated from the air adapter tube 9400.

[0650] like Fig.25 and Fig.26 As shown, the mechanical connector (e.g., clamp arm 4177) of the air delivery tube 4170 can be configured as a separate and distinct clip member 4185 that is configured to provide a releasable connection with the cuff portion 4171 of the air delivery tube 4170, for example, similar to the clip member 9450 described herein. For example, the clip member 4185 can be arranged within a recess of the cuff portion 4171, wherein a plurality of lugs of the clip member 4185 fit into corresponding side recesses to forcibly and releasably interconnect the clip member 4185 with the cuff portion 4171 in an assembled position. In another example, the clip member and the cuff portion can be integrally formed as a one-piece structure.

[0651] However, it should be understood that the distal end 9430 and the air delivery tube 4170 can be connected to the air delivery tube 4170 in other suitable ways. In an alternative example, the distal end 9430 and the cuff portion 4171 can include equal tapers configured to connect to each other with an interference fit or a friction fit.

[0652] In the illustrated example, the air delivery tube 4170 does not include any sensors (e.g., temperature sensors, pressure sensors, etc.). In an alternative example, the air delivery tube 4170 may include at least one sensor (e.g., temperature sensor), for example, not provided to the air adapter tube 9400.

[0653] When the air delivery tube 4170 is connected to the air adapter tube 9400, the cuff portion 4171 includes a tubular end portion 4181 that is configured to extend at least partially into the opening 9437 of the cuff portion 9432 so that at least a radially outward surface of the tubular end portion 4181 engages the cuff portion 9432 to form a substantially fluid-tight seal with the air adapter tube 9400 for delivering pressurized gas, e.g., see Fig.15 , Fig.16 and Fig.35 In one example, the leading end of the tubular end portion 4181 can engage a portion of the cuff portion 9432 to form a seal therewith.

[0654] In the example shown, Fig.12 , Fig.15 , Fig.16 , Fig.25 and Fig.26 As shown, the collar portion 9432 includes a radially inwardly extending protrusion 9439 that is configured to engage with a corresponding recess 4189 in the tubular end portion 4181 when the air delivery tube 4170 is connected to the air adapter tube 9400, for example to facilitate alignment and prevent relative rotation.

[0655] In the illustrated example, the proximal ends 9420 of the air adapter tube 9400 and the air delivery tube 4170 include similar mechanical and pneumatic connectors (e.g., a pair of resilient quick release clamp arms 9454, 4177 and tubular ends 9445, 4181) that are configured to allow both the air adapter tube 9400 and the air delivery tube 4170 to form mechanical and pneumatic connections with the patient interface 3000, e.g., the air adapter tube 9400 and the air delivery tube 4170 can be independently connected to the patient interface 3000.

[0656] In one example, if Fig.12 , Fig.15 , Fig.17 , Fig. 20 and Fig.25 As shown, the collar portion 9432 of the distal end 9430 can include an indicator or guide (e.g., alignment arrow 9433) that is configured to align with a corresponding indicator or guide (e.g., alignment arrow 4173) provided to the collar portion 4171 of the air delivery tube 4170, for example, to facilitate and confirm proper orientation, alignment, and connection of the air adapter tube 9400 with the air delivery tube 4170.

[0657] When the air adapter tube 9400 is connected to the air delivery tube 4170, the electrical contacts 9435 of the air adapter tube 9400 are arranged to engage with corresponding contacts of the electrical connector 4175 provided to the air delivery tube 4170 to form an electrical and control signal connection with the air delivery tube 4170, see e.g. Fig.35 . In the example shown, the lead frame having electrical contacts 9435 on the air adapter tube 9400 is arranged as a male connector that is configured to form an electrical connection and a signal connection when inserted into engagement with an electrical connector 4175 that is arranged as a female connector on the air delivery tube 4170, i.e., a plug-in connection or direct plug-in connection. The electrical connector 4175 electrically connects its contacts to corresponding wires extending along the air delivery tube 4170. In one example, the electrical connection can be facilitated by using, for example, serial communications (such as RS485). However, it should be understood that the electrical contacts can have alternative constructions and arrangements, for example, depending on the interface arrangement or connection mechanism provided between the air adapter tube and the air delivery tube.

[0658] Electrical conductors 9414 (wires) extending along the tubular body electrically connect the electrical connector 9434 to a transceiver (e.g., FPC 9480) and / or one or more sensors at the proximal end 9420. Thus, electrical signals (e.g., from one or more sensors) can be transmitted from the proximal end 9420 to the distal end 9430, from the distal end 9430 to the air delivery tube 4170, and from the air delivery tube 4170 to the RPT device or flow generator (e.g., the RPT device or flow generator can be configured to be controlled based on output from the one or more sensors).

[0659] As described herein, the air adapter tube 9400 includes at least one sensor, such as a pressure sensor 9490, a temperature sensor 9492, supported at the proximal end 9420 by the FPC 9480. In an example, the at least one sensor may include a pressure sensor 9490 and / or a temperature sensor 9492 as described herein, and may also include one or more additional sensors, such as a flow rate sensor, a humidity sensor, and / or an inertial sensor. The inertial sensor may include, for example, an accelerometer, a gyroscope sensor, a magnetometer, etc.

[0660] The at least one sensor can generate one or more output signals that can be transmitted to a controller for diagnosing and / or treating a respiratory disorder. For example, the pressure sensor 9490 can be configured to generate a pressure signal of the air passing through the proximal end 9420 for diagnosis and / or treatment of a respiratory disorder. The temperature sensor 9492 can be configured to generate a signal indicating the temperature of the air at the proximal end 9420. The accelerometer sensor can be configured to generate a signal indicating patient movement and / or patient sleeping position, which data can be used to allow personalization of the patient interface based on detected sleep patterns.

[0661] In one instance, FPC 9480 can be provided with a sensor configured to generate a signal indicative of respiration of a patient's exhaled gases and / or a biomarker of a patient's exhaled gases, such as a CO2 sensor, a biomarker sensor.

[0662] For example, the proximal end 9420 may include a CO2 sensor configured to detect CO2 accumulation, rebreathing CO2 levels, and / or breathing comfort. In one instance, the CO2 sensor is disposed in the patient interface, between the patient and the ventilation on the patient interface, i.e., in a position that facilitates detection of gas exhaled by the patient. In one instance, the sensor or the ventilation can be moved or repositioned so that the CO2 sensor is disposed upstream of the ventilation, i.e., allowing the sensor to detect exhaled gas before leaving the patient interface via the ventilation. In one instance, data from the CO2 sensor can be transmitted to the RPT device and used to control (e.g., dynamically), for example, the pressure supplied to the patient. For example, if the CO2 reading is high (e.g., above a threshold amount), the pressure supplied from the RPT device can be increased. The resulting increased pressure (e.g., and corresponding flow) can be used to reduce the patient's CO2 level.

[0663] In one example, the CO2 sensor can be configured to detect end-tidal CO2, which can be an indicator of the patient's health. For example, a low end-tidal CO2 reading can indicate poor perfusion, hypovolemia, or sepsis, while a high end-tidal CO2 reading can indicate airway narrowing, airway obstruction, or respiratory distress. The end-tidal CO2 reading can help a healthcare provider determine whether the patient is adequately ventilated. In one example, the end-tidal CO2 reading can be collected within the air adapter tube, i.e., a CO2 sensor does not need to be provided within the patient interface.

[0664] In one example, the proximal end 9420 may include a VOC (volatile organic compound) sensor configured to detect biomarkers within the patient's breath. For example, the VOC sensor may be configured to detect asthma, diabetes, lung cancer, alcohol, and other health conditions.

[0665] In one example, the CO2 sensor and / or VOC sensor can be configured to take a reading prior to treatment, i.e., the CO2 sensor and / or VOC sensor can be analyzed before treatment before pressurized treatment air is delivered by the RPT device or flow generator. For example, before starting treatment, the patient can wear a patient interface (which is operably connected to the RPT device via the air adapter tube 9400) for one or more breathing cycles (e.g., 1-10 breaths), which allows the CO2 sensor and / or VOC sensor provided to the air adapter tube 9400 to be read for analysis before the patient starts treatment. After one or more breathing cycles, the RPT device can be activated to deliver pressurized breathable air for treatment. In one example, readings from the CO2 sensor and / or VOC sensor can be provided to the patient in real time, or can be provided to a health professional for analysis prior to communication with the patient. In this example, the patient interface is worn, and treatment is delayed for one or more breathing cycles to allow sensing to be completed by one or more sensors (e.g., CO2 sensor and / or VOC sensor).

[0666] In one instance, readings from the CO2 sensor and / or VOC sensor can be automatically performed at the start of treatment, prior to starting treatment, and / or prior to providing airflow to the patient. In some instances, a patient wearing a patient interface can be automatically detected (e.g., based on readings from an accelerometer, etc.), and then used to trigger (in whole or in part) the CO2 sensor and / or VOC sensor to obtain data related to the patient's breathing. In one instance, readings from the CO2 sensor and / or VOC sensor can be obtained as part of a startup process for the RPT device. The startup process can include additional aspects, such as checking the type of patient interface (via a label as discussed herein), verifying the firmware installed in the RPT device, and / or parameters used in the treatment to be provided. Thus, in some instances, data acquisition from the CO2 sensor and / or VOC sensor can be performed without having to explicitly prompt, for example, the patient to perform such a reading.

[0667] In one example, the air adapter tube 9400 may include one or more additional features to enhance control and / or sensing capabilities. For example, the air adapter tube 9400 may include an on / off button for controlling power and / or may control power by touch based on an accelerometer sensor. The air adapter tube 9400 may include a tube temperature up / down button to control the air temperature of the delivered air. The air adapter tube 9400 may include a tube humidity up / down button to control the air humidity of the delivered air. The air adapter tube 9400 may include an optical or color sensor to detect one or more colors (e.g., a color ring or grayscale gradient) on a portion of the patient interface or elbow, for example, to detect patient movement or sleeping position. The air adapter tube 9400 may include a light sensor to project light and facilitate paced breathing. The air adapter tube 9400 may include a microphone for detecting snoring, mouth leakage, voice commands, for example.

[0668] In one example, ventilation can move from the patient interface and into an air adapter tube (e.g., within the proximal end 9420 adjacent to the patient interface), where ventilation can be active and controlled (e.g., electric and / or pneumatic).

[0669] In one instance, the FPC 9480 includes an antenna 9100, such as a near field communication (NFC) antenna. In one instance, the antenna 9100 is configured to wirelessly transmit the collected sensor data to an external device, including a smart phone or a flow generator. Similar to the examples described herein, the antenna 9100 is configured to face the proximal end and be located in a plane that is approximately perpendicular to the axis of the proximal end 9420. The antenna 9100 forms an opening around or encircling the lumen of the air adapter tube. The antenna 9100 is secured and electrically coupled to the FPC 9480 by a bridge 9494, and the bridge 9494 includes one or more flexible portions to allow the antenna to bend relative to the FPC 9480 (e.g., approximately 90 degrees), for example, see Figure 27 to Figure 29 and Fig.38 Antenna 9100 may have any or all of the characteristics of the antennas described herein.

[0670] Because the antenna 9100 is disposed in the proximal end 9420 of the air adapter tube 9400, the antenna 9100 is configured to be positioned near the connection port 3600 of the patient interface 3000 when the air adapter tube 9400 is coupled to the patient interface 3000, see e.g. Figure 36 to Figure 37 This arrangement allows the antenna 9100 to receive data transmitted from a tag disposed on the patient interface 3000 (which may be the same as or similar to the tag 9200 , such as an RFID tag, an NFC tag, etc.). Fig.36 and Fig.37An example of where label 3607 may be located is shown. Label 3607 may be the same as or similar to label 9200 and used in the manner described herein, such as to identify data of a patient interface and / or a patient.

[0671] In the example shown, the FPC 9480 includes at least one wire connection point that connects the FPC 9480 and the antenna 9100 to at least one wire (e.g., electrical conductor 9414) extending along and from the tubular body 9410. For example, Fig.29 and Fig.38 As shown, the FPC 9480 can include a bonding area 9484 that is configured to allow the FPC 9480 to form a bond (e.g., a weld seam, a welded bond) with each of the electrical conductors 9414 (e.g., 4 wires).

[0672] In the example shown, the FPC 9480 includes linear portions that support the electronic components and at least one flexible curved portion between the linear portions to allow the FPC 9480 to bend or flex around the first adapter element 9460. In one example, the electronic components can be disposed on one or both sides of the FPC. In one example, the electronic components can include a pressure sensor 9490, a temperature sensor 9492, and / or an accelerometer sensor configured to signal a sleeping position. In one example, the electronic components can include one or more sensors configured to generate a signal representative of breathing and / or a biomarker indicative of a patient's health.

[0673] In the example shown, see for example Fig.36 and Fig.37 , the air adapter tube 9400 is directly connected to the patient interface 3000 (i.e., there are no elbows or additional connectors between the air adapter tube and the patient interface), which allows one or more sensors (and antennas) provided to the FPC 9480 to be very close to the patient interface and its respiratory chamber for collecting data. However, it should be understood that the air adapter tube 9400 can be arranged along the air delivery path between the patient interface and the RPT device in other suitable manners. For example, the air adapter tube 9400 can be configured to connect to an upper tube patient interface and a lower tube patient interface according to any of the examples described herein. For example, in FIG. 10B to FIG. 10D In the lower tube example shown, the air adapter tube 9400 can be configured to connect between the patient interface 3000 and the air delivery tube 4170 (e.g., via an elbow), while Fig. 10A In the upper tube example shown, the gas adapter tube 940O can be configured to connect the head sleeve and the air delivery tube 4170 (e.g., via an elbow).

[0674] Fig.399400', and the RPT device 4000, the patient interface 3000, and one or more external systems 9520, all of which can communicate with each other using wired and / or wireless communications. Adapter 9400' can be the same or similar to adapter 9400 discussed herein. Aspects of adapter 9400 can be similarly applied to adapter 9400', and aspects of adapter 9400' can be similarly applied to adapter 9400.

[0675] The adapter 9400' includes a PCB 9500, which may be flexible in some instances. The adapter 9400' includes an antenna 9100 coupled to a transceiver 9300, which is configured to read data from a tag 9200 of the patient interface 3000. The antenna 9100 may be electrically connected to the transceiver 9300 to transmit radio waves and receive signals from, for example, the tag 9200.

[0676] The adapter 9400' also includes one or more sensors 9504, a memory 9506, a transceiver 9508, and a controller 9502. The sensor 9504 may include any or all of the sensors discussed herein. Examples of sensors 9504 include a pressure sensor 9490 and a temperature sensor 9492. A memory 9506 is provided for local storage (e.g., on the adapter 9400') of data received from the sensor 9504, the transceiver 9300, etc. The memory 9506 may also store program instructions that enable the controller 9502 to perform operations. In some instances, the memory 9506 may be part of the controller (e.g., as a system on a chip (SoC)). In any instance, the adapter 9400' also includes a power management system configured to provide an appropriate level of power to one or more sensors 9504, the memory 9506, the transceiver 9508, the controller 9502, and the transceiver 9300.

[0677] The transceiver 9508 is included in the adapter 9400' to provide data communication functionality for transmitting data between the adapter 9400' and the RPT device 4000 (or other destination as desired). The transceiver 9508 can provide both wired, wireless, or wired and wireless communications. In some examples, the transceiver 9508 can be provided as part of the same circuit as the transceiver 9300. Thus, for example, the adapter 9400' can include a first transceiver that is wireless for transmitting the tag 9200 and a second transceiver that is wired for communicating with, for example, the RPT device 4000 using a physical link (e.g., wires).

[0678] In one example, transceiver 9508 provides a data link as described above, and also provides power to a power management system of adapter 9400'. Power may be provided from an RPT device (eg, as discussed herein) or may be provided via a battery or other power source.

[0679] The adapter 9400' also includes a controller 9502. The controller 9502 may include or be a hardware processor that is configured to execute computer executable instructions to perform one or more operations. For example, the controller 9502 may control the sensor 9504 and / or the transceiver 9300 to acquire data (e.g., for a physical phenomenon or data from the tag 9200). In some cases, the controller 9502 controls when data is transmitted to the RPT device 4000 (e.g., via a corresponding data link) and / or when data is acquired via the sensor 9504 and / or the transceiver 9300. The controller 9502 may include a hardware processor (e.g., an ARM microprocessor), memory (e.g., for programs and data), and I / O on a single integrated circuit. An illustrative example of a controller that can be used in the illustrative example of the adapter 9400' is a STM32G071EBY6TR microcontroller.

[0680] In some instances, the controller 9502 can be used to determine when the patient interface is worn or used. This can be determined by, for example, interpreting data from an acceleration sensor to determine when the patient is wearing the patient interface 3000. Based on this determination, the controller can activate one or more sensors to obtain data. For example, the CO2 sensor and / or (VOC) sensor discussed here can be activated to obtain data from these sensors. This activation can occur before the airflow is delivered to the patient. In some instances, when the reading from the airflow sensor (e.g., also provided in the adapter) indicates that no airflow is delivered to the patient, the controller can activate the CO2 sensor and / or (VOC) sensor.

[0681] The components of the adapter 9400' may all be provided on the same PCB 9500, or may be provided separately. For example, some or all sensors may be provided separately from the PCB 9500 and electrically coupled to the PCB via leads or the like. Fig.38 In other examples shown, the sensor (eg, pressure sensor 9490) may be disposed on the PCB. Note that the antenna may be partially (or fully) integrated into the PCB 9500, as it may be electrically connected to the transceiver 9300 disposed on the PCB 9500.

[0682] According to various example embodiments, the controller 9502 may provide different types of functionality. In some instances, the functionality of the controller 9502 may include pre-processing or post-processing of data acquired from the sensor and / or tag 9200. For example, various filtering, averaging, and / or other processing may be performed by the controller 9502. In other instances, the functionality of the controller 9502 may be more limited because the data from the sensor is transmitted back to the RPT device 4000 for processing by the controller 4230 thereon. Thus, in some instances, the controller 9502 may be responsible for processing or analyzing what is acquired, and in other instances may be responsible for operating different components of the adapter 9400' without performing such processing or analysis. Instead, such processing may be performed by the RPT device 4000 and / or the external system 9520.

[0683] As noted herein, each of the proximal end 9420 and the distal end 9430 of the air adapter tube 9400 may include a uniformly tapered body configured to allow the air adapter tube 9400 to be connected between any patient interface and an air delivery tube, rather than a custom mechanical connection (e.g., a snap-fit ​​clamp arm), i.e., the air adapter tube 9400 is not limited to use with a patient interface or an air delivery tube having a compatible mechanical connector. In addition, unlike a custom electrical connection for a heated air delivery tube (e.g., a lead frame with electrical contacts) for power / signal transmission, the distal end 9430 may be provided without any lead frame / electrical contacts, i.e., the air adapter tube 9400 is not limited to use with an air delivery tube having a compatible electrical connector. In this arrangement, the air adapter tube 9400 may include a power source (e.g., a rechargeable battery) configured to provide power to one or more sensors, FPCs, antennas, etc. In addition, any signal transmission, such as NFC, Bluetooth, etc., may be provided via the antenna. Such an air adapter tube 9400 would provide an agnostic tube configured to be compatible with different patient interfaces and air delivery tubes, i.e., not limited to a specific patient interface, air delivery tube, or system.

[0684] In the illustrated example, the air adapter tube 9400 is in the form of a short tube, for example, between about 5-15 cm in length, such as 8.5-10 cm. In an alternative example, the air adapter tube can be in the form of a ring adapter, for example, a cuff or ring similar in size to the proximal end 9420 (e.g., 1-4 cm). Such a ring adapter can include an FPC, one or more sensors, an antenna in a cuff configured for connection between a patient interface and an air delivery tube. As described herein, such a ring adapter can include a power source (e.g., a rechargeable battery), thereby allowing such a ring adapter to be agnostic configured to be compatible with different patient interfaces and air delivery tubes.

[0685] 5.5.1 Multi-directional Antenna

[0686] 9A to 9D Various configurations of one or more antennas 9100 and one or more tags 9200 are shown. Because the antennas 9100 and tags 9200 are inductively coupled to each other through a magnetic field, the antennas 9100 and tags 9200 can be configured within the RFID system 9000 to optimize efficient energy transfer through the magnetic field. For example, the antennas 9100 and tags 9200 can be configured to optimize the read distance between the antennas 9100 and tags 9200. In less optimal relative orientations, the read distance may be affected between the antennas 9100 and tags 9200.

[0687] Fig.9A A first configuration is described in which the antenna 9100 is oriented substantially parallel relative to the tag 9200. For example, the antenna 9100 can be positioned facing the tag 9200. This configuration can optimize the magnetic field between the antenna 9100 and the tag 9200, thereby allowing an increased read distance between the antenna 9100 and the tag 9200. For example, the antenna 9100 and the tag 9200 can be spaced farther apart from each other and still operate in the RFID system 9000. This configuration can be used with Fig. 9B A second, less optimized configuration is shown for comparison.

[0688] Fig. 9B A second configuration is depicted in which the antenna 9100 and the tag 9200 are offset approximately 90 degrees relative to each other. Due to the different read angles between the antenna 9100 and the tag 9200, this second configuration may be less than ideal. For example, the ability of the antenna 9100 to read the tag 9200 from this angle may be reduced at least in part due to the different read angles. Thus, in this second configuration, the magnetic field between the antenna 9100 and the tag 9200 may not be optimal. Fig.9A Compared with the configuration of FIG. 91 , the reading distance between the antenna 9100 and the tag 9200 is reduced in this configuration.

[0689] Therefore, the optimization of the magnetic field between the antenna 9100 and the tag 9200, and therefore the ability of the antenna 9100 to read the tag 9200 at a given distance, is proportional to the angle at which the antenna 9100 and the tag 9200 are oriented relative to each other. For example, the magnetic field between the antenna 9100 and the tag 9200 can be optimized when the angle between the antenna 9100 and the tag 9200 is small, such as Fig.9A The magnetic field between the antenna 9100 and the tag 9200 can be reduced as the antenna 9100 and / or the tag 9200 are angled relative to each other, as shown in FIG. Fig. 9B shown.

[0690] In the context of the system 8000 described above, the angle between the tag 9200 incorporated into the patient interface and the antenna 9100 incorporated into the accessory or air circuit 4170 can depend on many factors. For example, if the antenna 9100 is incorporated into the air circuit 4170, the angle at which the air circuit 4170 is connected relative to the patient interface 3000 can vary greatly for different types of patient interfaces. Figure 4P As shown, and as described above, a variety of configurations of the patient interface are possible. In addition, the situation in which the tag 9200 is incorporated into the patient interface 3000 may also affect the relative orientation of the tag 9200 and the antenna 9100 when the air circuit 4170 is coupled to the patient interface 3000.

[0691] Fig. 9C and Fig.9D The multi-directional antenna configuration shown in FIG. 4 can be configured to compensate for differences in attachment angles between the air circuit 4170 and the patient interface 3000 and can facilitate reading over a wider range of angles and mitigate the above referenced Fig. 9B One or more effects on read distance described. The disclosed multi-angle antenna configuration can be designed to arrange multiple antennas in a three-dimensional shape to create an effective read orientation between the antenna 9100 and the tag 9200 across a variety of different patient interface types.

[0692] exist Fig. 9C In the configuration shown, the two antennas 9100A and 9100B can be angled relative to each other and oriented so that the first antenna 9100A and the second antenna 9100B face in different directions. Thus, the first antenna 9100A and the second antenna 9100B are configured to provide a reading angle in two directions. Fig. 9C The orientation of the tag 9200 in FIG. 4 may indicate the location of the tag 9200 on a patient interface or accessory, and the orientation of the first antenna 9100A and the second antenna 9100B relative to the tag 9200 may indicate the location of the first antenna 9100A and the second antenna 9100B on the air circuit 4170 when connected to a patient interface or accessory. Fig. 9C In the illustrated configuration, the relative orientation of the first antenna 9100A and the second antenna 9100B can be similar to an "8-shaped" configuration to provide a bidirectional reading angle. For example, the first antenna 9100A is configured to provide a first reading angle in a first direction, and the second antenna 9100B is configured to provide a second reading angle in a second direction. The reading direction relative to the tag 9200 is determined by Fig. 9C As depicted by the arrows shown in . In this way, the tag 9200 can be effectively read from multiple directions. For example, the tag 9200 can be read by the first antenna 9100A or the second antenna 9100B, depending on the position of the tag 9200 relative to the first antenna 9100A and the second antenna 9100B. Fig. 9C In the arrangement of , the tag 9200 can be read by the first antenna 9100A because the first antenna 9100A can be an antenna with a reading angle that is more directly oriented with respect to the tag 9200.

[0693] The first antenna 9100A and the second antenna 9100B can be offset relative to each other by an angle A. Angle A can be approximately 90 degrees. Alternatively, angle A can be greater than 90 degrees or less than 90 degrees. For example, angle A can be approximately 30 degrees to approximately 120 degrees, or any other suitable angle.

[0694] In some cases, the first antenna 9100A, the second antenna 9100B, and the tag 9200 may be set to a frequency of 13.56 MHz. If the resonant frequency is close to the reader carrier frequency (13.56 MHz), the power transfer and communication distance between the reader and the tag may be increased. Although the frequency of 13.56 MHz is used as an example, as described above, any other suitable frequency may be used.

[0695] Fig.9D Another multi-directional antenna arrangement is described that may include additional antennas of more complex three-dimensional shapes. In this configuration, the first antenna 9100A, the second antenna 9100B, the third antenna 9100C, the fourth antenna 9100D, and the fifth antenna 9100E are oriented to provide reading angles in multiple directions. Fig.9D The orientation of the tag 9200 in the figure can represent the location of the tag 9200 on the patient interface or accessory, and the orientation of the antennas 9100A-9100E can represent the location of the antennas 9100A-9100E on the air circuit 4170 when attached to the patient interface or accessory. Although five antennas are shown, more antennas can be used to increase the number of reading directions, or fewer antennas can be used to reduce the number of reading directions. For example, three, four, six, seven, or eight or more antennas can be used.

[0696] Fig.9D Embodiments of the invention may be adapted for use with a variety of patient interfaces having a variety of different attachment orientations of the air circuit 4170 relative to the patient interface 3000 and the label 9200. Additionally, in some aspects, as described above, the air circuit 4170 may be configured to move or rotate relative to the patient interface 3000 when connected to the patient interface 3000. For example, there may be a swivel joint in the air circuit 4170, or a patient interface connector. Because Fig.9DThe antenna arrangement includes multiple antennas that are oriented to face multiple different directions, so that the tag 9200 can receive a portion of the field transmitted by the multi-directional antennas even when the air circuit 4170 moves relative to the patient interface when connected to the patient interface. As the air circuit 4170 moves, different antennas in the multi-directional configuration can be used to read the tag 9200, depending on which antenna is most closely aligned with the tag 9200.

[0697] In some cases, the first antenna 9100A, the second antenna 9100B, the third antenna 9100C, the fourth antenna 9100D, and the fifth antenna 9100E can be set to a frequency of 13.56 MHz. If the resonant frequency is close to the reader carrier frequency (13.56 MHz), the power transfer and communication distance between the reader and the tag can be increased. Although the frequency of 13.56 MHz is used as an example, as described above, any other suitable frequency can be used.

[0698] FIG. 10A to FIG. 10D Various configurations between various patient interfaces and air circuits are shown. For example, FIG. 9C to FIG. 9D The antenna and tag configuration shown can be used in FIG. 10A to FIG. 10D An efficient reading orientation is created in the configuration shown.

[0699] For example, Fig. 10A Frame 10000 of an upper tube nose patient interface is shown. In some embodiments, frame 10000 can be used with patient interface 3000, such as Fig. 8A and Figure 8B 10000. The frame 10000 is configured such that the air circuit 4170 is coupled to the frame 10000, for example, via a joint 10002 at or near the top of the user's head. The air circuit 4170 can be rotatably coupled relative to the frame 10000 via the joint 10002. The joint 10002 can be a rotating joint, thereby allowing the air circuit 4170 to rotate relative to the frame 10000. As shown, the frame 10000 and the air circuit 4170 are at an angle of approximately 90 degrees to each other. Therefore, the antenna 9100 fixed in or on the proximal portion of the air circuit 4170 can be angled relative to the tag 9200 fixed in or on the frame 10000.

[0700] As described above, the orientation of antenna 9100 and tag 9200 may affect the ability of antenna 9100 to read tag 9200. Fig. 10A In the illustrated configuration, if a single two-dimensional antenna 9100 is used as shown, the reading efficiency between the antenna 9100 and the tag 9200 may be reduced. Using two or more antennas 9100 in the form of a multi-dimensional antenna, for example Fig. 9C and Fig.9DAs shown, the reading efficiency between the antenna 9100 and the tag 9200 can be increased in this configuration. Fig.9D As shown, the first antenna 9100A, the second antenna 9100B, the third antenna 9100C, the fourth antenna 9100D and / or the fifth antenna 9100E can be used in this configuration. The use of multiple antennas arranged in a three-dimensional configuration can facilitate effective reading of the tag 9200 regardless of the orientation of the air circuit 4170 relative to the frame 10000 when connected.

[0701] Fig. 10B An alternative configuration between a patient interface 3000 and an air circuit 4170 is shown, for example, a tube-down nasal patient interface (according to any of the examples described herein). The air circuit 4170 can be connected to the patient interface via a connector 11000. The connector 11000 can allow the air circuit 4170 to rotate, for example, about an axis X. Depending on how the air circuit 4170 and the patient interface 3000 move relative to each other, using a single two-dimensional antenna 9100 as shown may result in reduced reading efficiency in some relative configurations. Using two or more antennas 9100 in the form of a multi-dimensional antenna, for example, as Fig. 9C and Fig.9D As shown, it is possible to increase the reading efficiency between the antenna 9100 and the tag 9200. For example, Fig.9D As shown, the first antenna 9100A, the second antenna 9100B, the third antenna 9100C, the fourth antenna 9100D and / or the fifth antenna 9100E can be used in this configuration. The use of multiple antennas arranged in a three-dimensional configuration can facilitate effective reading of the tag 9200 regardless of the orientation of the air circuit 4170 relative to the patient interface 3000.

[0702] Fig. 10C and Fig. 10D Another optional configuration between the patient interface 3000 and the air circuit 4170 is shown. For example, in this configuration, the patient interface 3000 is a down tube full face patient interface. The air circuit 4170 can be connected to the patient interface via a joint 12000. The joint 12000 can be a swivel joint, thus allowing the air circuit 4170 to rotate. For example, the joint 12000 can allow rotation about the axis Y of the patient interface 3000, as well as movement of the air circuit 4170 relative to the patient interface 3000. Fig. 10C and Fig. 10D Different positions of the air conduit relative to the patient interface 3000 and the label 9200 are depicted, for example depending on the different positions a patient may be in while wearing the patient interface 3000. As the patient moves during use, the air circuit 4170 may change direction unpredictably. Fig. 10C and Fig. 10DIn the position shown, the antenna 9100 and the tag 9200 can be offset from each other. For example, the antenna 9100 and the tag 9200 can be oriented such that the antenna 9100 and the tag 9200 are angled relative to each other. As previously described, the angle between the antenna 9100 and the tag 9200 can result in a less than optimal reading direction. As described above with reference to Fig. 10A and Fig. 10B As described, antenna 9100 in the form of two or more multi-dimensional antennas is used, for example, Fig. 9C and Fig.9D As shown, the reading efficiency between the antenna 9100 and the tag 9200 can be increased. Fig.9D As shown, a first antenna 9100A, a second antenna 9100B, a third antenna 9100C, a fourth antenna 9100D, and / or a fifth antenna 9100E may be used in this configuration. The use of multiple antennas arranged in a three-dimensional configuration may facilitate efficient reading of the tag 9200 regardless of the orientation of the air circuit 4170 relative to the patient interface 3000 when connected.

[0703] Each embodiment discussed herein can enable a user to detect the identification of a patient interface or accessory being used. In this way, information about the patient interface, accessory, patient, or prescribed treatment can be transmitted via RFID. Each embodiment can particularly help increase patient use and / or patient comfort.

[0704] It is obvious to those skilled in the art that various modifications and variations may be made to the disclosed device without departing from the scope of the present invention. Other embodiments of the present invention will be apparent to those skilled in the art in view of the specification and practice of the present invention disclosed herein. The specification and embodiments are considered to be exemplary only, and the true scope and spirit of the present invention are indicated by the appended claims.

[0705] 5.6 List of reference numerals

[0706]

[0707]

[0708]

[0709]

[0710]

[0711]

[0712]

[0713]

[0714]

[0715]

Claims

1. An air adapter tube for diagnosing and / or treating a respiratory disorder, comprising: a tubular body configured to deliver pressurized therapeutic air between a proximal end of the tubular body and a distal end of the tubular body, the proximal end configured for connection to a patient interface and the distal end configured for connection to an air delivery tube; Characterized in that the air adapter tube further comprises: A sensor is configured to generate a signal based on air passing through the proximal end for diagnosing and / or treating a breathing disorder.

2. An air adapter tube for diagnosing and / or treating a respiratory disorder, comprising: a tubular body configured to deliver pressurized therapeutic air between a proximal end of the tubular body and a distal end of the tubular body, the proximal end configured for connection to a patient interface and the distal end configured for connection to an air delivery tube; Characterized in that the air adapter tube further comprises: A sensor is configured to generate a signal indicative of a sleeping position of the patient.

3. An air adapter tube for diagnosing and / or treating a respiratory disorder, comprising: a tubular body configured to deliver pressurized therapeutic air between a proximal end of the tubular body and a distal end of the tubular body, the proximal end configured for connection to a patient interface and the distal end configured for connection to an air delivery tube; Characterized in that the air adapter tube further comprises: A sensor is configured to generate a signal indicative of the respiration and / or biomarker of gas exhaled by the patient.

4. An air adapter tube for use in diagnosing and / or treating a respiratory disorder, comprising: a tubular body configured to deliver pressurized therapeutic air between a proximal end of the tubular body and a distal end of the tubular body, the proximal end configured to be removably coupled to a patient interface and the distal end configured to be removably coupled to an air delivery tube; Characterized in that the air adapter tube further comprises: a sensor configured to generate a signal based on a sensed physical quantity; and An antenna configured to receive data from an RFID tag.

5. The air adapter tube according to any one of claims 1 and 4, characterized in that The sensor comprises a pressure sensor.

6. The air adapter tube according to any one of claims 2 and 4, characterized in that The sensor includes an accelerometer.

7. The air adapter tube according to any one of claims 3 and 4, characterized in that The sensor is a CO2 sensor.

8. The air adapter tube according to claim 7, characterized in that The CO 2 sensor is configured to detect CO 2 accumulation, rebreathing CO 2 levels and / or breathing comfort.

9. The air adapter tube according to claim 7, characterized in that The CO2 sensor is configured to be disposed between the patient and a vent on the patient interface.

10. The air adapter tube according to claim 7, characterized in that The CO 2 sensor is configured to detect end-tidal CO 2 .

11. The air adapter tube according to claim 5, characterized in that The sensor is a volatile organic compound sensor configured to detect a biomarker in the breath of the patient.

12. The air adapter tube according to claim 11, characterized in that The sensor is a CO2 sensor and / or a volatile organic compound sensor, and Characterized in that the CO2 sensor and / or the volatile organic compound sensor are configured to perform a pre-treatment analysis before pressurized therapeutic air is delivered to the patient interface.

13. The air adapter tube according to any one of claims 1 to 4, characterized in that The tubular body comprises a flexible material.

14. The air adapter tube according to any one of claims 1 to 4, characterized in that The inner diameter of the tubular body is between about 10-15 mm.

15. The air adapter tube according to claim 14, characterized in that The inner diameter of the tubular body is 12 mm.

16. The air adapter tube according to any one of claims 1 to 4, characterized in that The length of the tubular body is between about 8.5-10 cm.

17. The air adapter tube according to claim 16, characterized in that The length is about 8.5 cm.

18. The air adapter tube according to any one of claims 1 to 4, characterized in that The outer surface of the tubular body includes or is covered with a fabric material.

19. The air adapter tube according to any one of claims 1 to 4, characterized in that The tubular body includes a helix.

20. The air adapter tube according to any one of claims 1 to 4, characterized in that The proximal end includes a mechanical connector configured for connection to the patient interface.

21. The air adapter tube of claim 20, wherein: The mechanical connector includes a split spring coil having a pair of opposing clips configured to be connected to the patient interface.

22. The air adapter tube of claim 20, wherein: The mechanical connector includes an equal-taper body configured to connect with the patient interface by an interference fit or a friction fit.

23. The air adapter tube according to any one of claims 1 to 4, characterized in that The air adapter tube further includes a flexible printed circuit supporting the sensor at the proximal end.

24. The air adapter tube according to any one of claims 1 to 3, characterized in that The air adapter tube further includes an antenna.

25. The air adapter tube of claim 4, wherein: The antenna is configured to wirelessly transmit the collected sensor data to an external device including a smartphone or a flow generator.

26. The air adapter tube of claim 4, wherein: The air adapter tube further includes at least one wire connection point connecting the antenna to at least one wire extending along and from the tubular body.

27. The air adapter tube of claim 23, wherein: The flexible printed circuit includes a plurality of linear portions for supporting electronic components and at least one flexible curved portion between the linear portions.

28. The air adapter tube of claim 27, wherein: One of the electronic components is a pressure sensor and another of the electronic components is an accelerometer sensor configured to generate a signal indicative of a sleeping position of a patient.

29. The air adapter tube of claim 27, wherein: The electronics include one or more sensors configured to generate a signal representative of respiration and / or a biomarker indicative of a patient's health.

30. The air adapter tube of claim 29, wherein: The one or more sensors include a CO2 sensor or a volatile organic compound sensor.

31. The air adapter tube according to any one of claims 1 to 4, characterized in that The air adapter tube further includes a temperature sensor configured to generate a signal indicative of a temperature within the tubular body.

32. The air adapter tube according to any one of claims 1 to 4, characterized in that The air adapter tube further includes a first adapter element at the proximal end, the first adapter element supporting the sensor.

33. The air adapter tube of claim 32, wherein: The first adapter element comprises an outer cylindrical surface having a port, and the sensor protrudes radially inwardly into and / or through the port.

34. The air adapter tube of claim 33, wherein: The air adapter tube further includes silicone to seal the port adjacent the sensor.

35. The air adapter tube of claim 32, wherein: The air adapter tube further includes a second adapter element, and the second adapter element is connected and sealed to the membrane and the spiral wire of the tubular body.

36. The air adapter tube of claim 32, wherein: The air adapter tube further includes a cuff portion connected to the first adapter element, and is characterized in that the first adapter element and the cuff portion form an annular space configured to receive a flexible printed circuit supporting the sensor.

37. The air adapter tube of claim 36, wherein: The first adapter element includes at least one feature configured to support the flexible printed circuit, the at least one feature including a fastener and / or an adhesive.

38. The air adapter tube of claim 32, wherein: The air adapter tube further includes a vent along a periphery of the first adapter element.

39. The air adapter tube of claim 38, wherein: The air adapter tube further includes a waterproof pressure equalizing membrane provided to the vent hole and configured to regulate differential pressure at the proximal end.

40. The air adapter tube according to any one of claims 1 to 4, characterized in that The air adapter tube further includes an electrical connector provided at the distal end of the tubular body, the electrical connector being configured to electrically connect to a corresponding electrical connector of the hot air delivery tube.

41. The air adapter tube of claim 40, wherein: The electrical connector includes a lead frame configured to transmit power and / or signals.

42. The air adapter tube of claim 40, wherein: The air adapter tube further includes an indicator or guide adjacent the distal end, the indicator or guide being configured to align with a corresponding indicator or guide of the heated air delivery tube.

43. The air adapter tube of claim 40, wherein: The air adapter tube further includes at least one wire extending along the tubular body and electrically connecting the electrical connector to the sensor and / or the flexible printed circuit.

44. The air adapter tube of claim 40, wherein: The air adapter tube further includes a mechanical connector provided at the distal end of the tubular body, the mechanical connector being configured to mechanically connect to a corresponding mechanical connector of the heated air delivery tube.

45. The air adapter tube according to any one of claims 1 to 4, characterized in that The air adapter tube further includes a power source configured to provide power to the sensor and / or the flexible printed circuit.

46. ​​An air adapter tube according to any one of claims 1 to 4, It is characterized in that The sensor includes a plurality of sensors, and the plurality of sensors includes at least a first sensor, a second sensor, and a third sensor. characterised in that the first sensor is configured to generate a signal based on the air passing through the proximal end during treatment in order to diagnose and / or treat a respiratory disorder, characterised in that the second sensor is configured to generate a signal indicative of the sleeping position of the patient, and Characterized in that the third sensor is configured to generate a signal indicative of the respiration of the patient's exhaled air and / or a biomarker of the patient's exhaled air prior to application of therapy.

47. The air adapter tube according to any one of claims 1 to 4, characterized in that The air adapter tube further comprises: a first electrical connector configured to couple a first electrical wire configured to deliver power to the air delivery tube; and A second electrical connector is configured to be coupled to a second electrical wire, the second electrical wire being configured to send data to and receive data from the air delivery tube.

48. The air adapter tube of claim 4, wherein: The antenna is a multi-directional antenna comprising a plurality of antennas oriented at different angles relative to each other.

49. The air adapter tube of claim 48, wherein: The multi-directional antenna includes two antennas.

50. The air adapter tube of claim 48, wherein: The plurality of antennas include at least a first antenna and a second antenna, and are characterized in that the first antenna and the second antenna are oriented at an angle of about 30 degrees to about 120 degrees relative to each other.

51. The air adapter tube of claim 48, wherein: The plurality of antennas are configured to be at a frequency of about 10 MHz to about 12 GHz.

52. The air adapter tube according to any one of claims 1 to 4, characterized in that The sensor is supported at the proximal end.

53. A medical device for diagnosing and / or treating a patient suffering from a respiratory disorder, comprising: a flow generator configured to generate pressurized breathable air for the patient; a patient interface configured to seal with the patient's airway; an air delivery tube for delivering pressurized breathable air from the flow generator to the patient interface; Characterized in that the medical device further comprises: An air adapter tube according to any one of claims 1 to 52.

54. The medical device according to claim 53, characterized in that The flow generator is configured to be controlled based on an output from the sensor.

55. A system, characterized in that: The system comprises: An air adapter tube according to any one of claims 1 to 52; and At least one hardware processor configured to perform the following operations: Controlling when the sensor is configured to sense a physical quantity.

56. The system according to claim 55, characterized in that The sensor is controlled based on the determined patient position.

57. The system according to claim 55, characterized in that The sensor is controlled to sense the physical quantity before positive air pressure is delivered to the air adapter tube.

58. The system according to claim 55, characterized in that Based on determining that no positive air pressure is being delivered to the air adapter tube, the sensor is controlled to sense the physical quantity.

59. A system, characterized in that: The system comprises: An air adapter tube according to any one of claims 1 to 52; and At least one hardware processor is configured to perform operations including changing at least one treatment parameter based on the generated signal of the sensor.

60. The system of claim 55, wherein: The system further includes a patient interface including an RFID tag including data received by the antenna of the air adapter tube.

61. A system, characterized in that: The system comprises: The air adapter tube of any one of claims 1 to 52; and At least one hardware processor is configured to perform operations including causing a flow generator to adjust a generated pressure based on pressure data obtained from a pressure sensor of the air adapter tube.

62. A system, characterized in that: The system comprises: The air adapter tube of any one of claims 1 to 52; and At least one hardware processor configured to perform operations including causing a flow generator to adjust the generated pressure based on data obtained from a CO2 sensor of the air adapter tube.

63. The air adapter tube according to any one of claims 1 to 4, characterized in that The air adapter tube further comprises: A controller is electrically coupled to the sensor.

64. The air adapter tube of claim 63, wherein: The controller includes a hardware processor and a non-transitory computer-readable storage medium.

65. The air adapter tube of claim 64, wherein: Data acquired from the sensor is stored to the non-transitory computer-readable storage medium.

66. The air adapter tube of claim 4, wherein: The air adapter tube further includes a transceiver electrically coupled to the antenna.

67. The air adapter tube according to any one of claims 1 to 4, characterized in that The air adapter tube further includes a second transceiver configured to send and receive data to and from the flow generator.

68. The air adapter tube of claim 67, wherein: The second transceiver is a wired transceiver.

69. The air adapter tube of claim 67, wherein: The air adapter tube further comprises: A power management system wherein the second transceiver is further configured to electrically couple to a power source external to the air adapter tube and to deliver power from the power source to the power management system.

70. An air adapter tube for use in diagnosing and / or treating a respiratory disorder, comprising: a proximal end and a distal end, the proximal end being configured to be removably coupled to a patient interface and the distal end being configured to be removably coupled to an air delivery tube; Characterized in that the air adapter tube further comprises: a sensor configured to generate a signal based on a sensed physical quantity; a wireless reader configured to receive data from the RFID tag; and A controller is electrically coupled to the sensor and the wireless reader.

71. The air adapter tube of claim 70, wherein: The air adapter tube further includes a second transceiver configured to transmit sensor data to another device based on the sensed physical quantity.

72. The air adapter tube of claim 71, wherein: The second transceiver transmits the sensor data to the other device through a wired connection via the air delivery tube.

73. The air adapter tube of claim 71, wherein: The second transceiver transmits the sensor data to the other device using wireless communication.

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