Apparatus, system, and method for medical device detection

Abstract

An air adapter tube for diagnosing and / or treating a respiratory disorder includes a tubular body configured to transport pressurized therapeutic air between a proximal end and a distal end of the tubular body, the proximal end configured to connect to a patient interface and the distal end configured to connect to an air delivery tube, and a sensor configured to generate a signal based on air passing through the proximal end for diagnosing and / or treating a respiratory disorder.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Application No. 63 / 387,325 filed December 14, 2022, U.S. Provisional Application No. 63 / 487,311 filed February 28, 2023, U.S. Provisional Application No. 63 / 487,317 filed February 28, 2023, and U.S. Provisional Application No. 63 / 515,681 filed July 26, 2023, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] 2.1 Technical Field The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing and ameliorating respiratory-related disorders. The present technology also relates to medical devices or apparatus, systems and uses thereof.

[0003] 2.2 Description of Related Art 2.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways.

[0004] These airways contain a series of branches that become narrower, shorter, and more numerous the deeper they travel into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air to venous blood and carbon dioxide to move in the reverse direction. The trachea divides into right and left main bronchi, which further divide into terminal bronchioles. The bronchi constitute conducting airways and do not participate in gas exchange. The airways further divide into respiratory bronchioles and ultimately into alveoli. Gas exchange occurs in the alveolar region of the lung, which is called the respiratory region. See Respiratory Physiology, 9th Edition, John B. West, Lippincott Williams & Wilkins, 2012.

[0005] A variety of respiratory disorders exist, and particular disorders may be characterized by particular events, such as apnea, hypopnea, or hyperpnea.

[0006] Examples of respiratory diseases include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory failure, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular diseases (NMD), and chest wall disorders.

[0007] Obstructive sleep apnea (OSA), a type of sleep-disordered breathing (SDB), is characterized by upper airway obstruction or occlusion during sleep. This is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the tongue region, soft palate, and posterior oropharyngeal wall during sleep. This condition causes affected individuals to experience breathing pauses, typically lasting 30 to 120 seconds, sometimes 200 to 300 times per night. This can result in excessive daytime sleepiness, which can contribute to cardiovascular disease and brain damage. This syndrome is common, particularly among middle-aged, overweight men, but patients often experience no symptoms. See U.S. Pat. No. 4,944,310 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disturbance in a patient's respiratory control system, resulting in alternating periods of waxing and waning ventilation, known as the CSR cycle. CSR is characterized by repeated deoxygenation and reaeration of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with repeated awakenings from sleep, causing severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0009] Respiratory failure is a general term for respiratory disorders that occur when the lungs are unable to take in enough oxygen or expel enough CO2 to meet the patient's needs. Respiratory failure can include some or all of the following disorders:

[0010] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0011] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of any other clear cause of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics, including increased resistance to air movement, prolonged expiratory phase of breathing, and a decrease in normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0013] Neuromuscular disease (NMD) is a broad term encompassing numerous diseases and illnesses that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of walking ability, wheelchair use, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into the following: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only modestly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of NMD respiratory failure include increasing generalized weakness, difficulty swallowing, dyspnea on exertion and at rest, fatigue, drowsiness, morning headaches, and difficulty with attention and mood changes.

[0014] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive obstruction and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can lead to severe respiratory failure. Symptoms of respiratory failure include exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0015] A range of treatments are available to treat or ameliorate these conditions, and preventative treatments for respiratory disease are also available to otherwise healthy individuals. However, these treatments suffer from several deficiencies.

[0016] 2.2.2 Law A variety of respiratory therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) are used to treat one or more of the above-mentioned respiratory disorders.

[0017] 2.2.2.1 Respiratory pressure therapy Respiratory pressure therapy is the application of air to the entrance of the airways at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy, e.g., tank ventilators or positive-negative pressure extracorporeal ventilators (cuirass)).

[0018] Continuous positive airway pressure (CPAP) therapy is used to treat obstructive sleep apnea (OSA). Its mechanism of action is that CPAP therapy acts as a pneumatic splint, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, thereby preventing upper airway closure. Because CPAP therapy for OSA can be voluntary, patients may choose not to comply if they find the device used to deliver the therapy to be one or more of the following: uncomfortable, difficult to use, expensive, or unattractive.

[0019] Noninvasive ventilation (NIV) provides ventilatory support to a patient via the upper airways to assist the patient in breathing and / or maintain adequate oxygen levels in the body by completing some or all of the work of breathing. Ventilatory support is provided via a noninvasive patient interface. NIV is used to treat CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. Some forms may improve the comfort and effectiveness of these therapies.

[0020] Invasive ventilation (IV) provides ventilatory support to patients who can no longer breathe effectively on their own and may be provided using a tracheostomy or endotracheal tube. Some forms may improve the comfort and effectiveness of these therapies.

[0021] 2.2.2.2 Flow therapy Not all respiratory therapies are intended to deliver a prescribed therapeutic pressure. Some respiratory therapies aim to deliver a prescribed respiratory volume by delivering an inspiratory flow profile (perhaps superimposed on a positive baseline pressure) for a targeted duration. In other cases, the interface to the patient's airway is "open" (unsealed), and respiratory therapy with a conditioned or concentrated gas flow may be used only to support the patient's spontaneous breathing. In one example, high-flow therapy (HFT) involves providing a continuous, heated, humidified airflow to the entrance to the airway through an unsealed or open patient interface at a "therapeutic flow" that can be maintained nearly constant throughout the respiratory cycle. The therapeutic flow is nominally set to exceed the patient's peak inspiratory flow. HFT is used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that a high flow of air at the entrance to the airway improves ventilation efficiency by flushing or sweeping exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as dead space therapy (DST). Other benefits may include improved warmth and humidification (possibly through the benefit of secretory control) and a gradual increase in airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate may follow a profile that varies over the respiratory cycle.

[0022] 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 specific oxygen concentration (the fraction of oxygen in ambient air, from 21% to 100%) delivered to a patient's airways at a specific flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0023] 2.2.2.3 Supplemental oxygen For certain patients, oxygen therapy may be combined with respiratory pressure therapy, or HFT, by adding supplemental oxygen to the pressurized airflow. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, it is called HFT with supplemental oxygen.

[0024] 2.2.3 Respiratory Therapy Systems These respiratory treatments may be provided by respiratory therapy systems or devices. Such systems and devices may be used to screen, diagnose, or monitor disease without treating it.

[0025] The 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.

[0026] Another form of treatment system is the mandibular repositioning device.

[0027] 2.2.3.1 Patient Interface A patient interface may be used to interface with a respiratory appliance, for example, by providing airflow to an entrance to the airway. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy being applied, the patient interface may facilitate gas delivery at a pressure sufficiently different from ambient pressure, e.g., approximately 10 cmH2O positive pressure relative to ambient pressure, by forming a seal with, for example, a portion of the patient's face, to effectively implement the therapy. For other forms of therapy, such as oxygen delivery, the patient interface may not include sufficient sealing properties to facilitate delivery of a gas supply to the airway at a positive pressure of approximately 10 cmH2O. For flow therapies, such as nasal HFT, the patient interface is configured to insufflate the nares (and specifically avoid a complete seal). One example of such a patient interface is a nasal cannula.

[0028] Certain other mask systems may be functionally inadequate in this field. For example, purely decorative masks may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to protect against water intrusion from higher external pressures, but not to maintain internal air at pressures higher than ambient.

[0029] Certain masks may present clinical disadvantages to this technology, such as blocking airflow through the nose and allowing airflow only through the mouth.

[0030] Certain masks may be uncomfortable or impractical with current technology if they require the patient to insert part of the mask structure into their mouth to form and maintain a seal via the lips.

[0031] Some masks cannot be used while sleeping, such as when sleeping on your side in bed or with your head resting on a pillow.

[0032] Designing 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 among individuals. Because the head contains bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. That is, the chin or mandible can move relative to the other bones of the skull. The entire head can move throughout the respiratory treatment period.

[0033] These challenges can lead to one or more of the following: some masks can be intrusive, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable, especially when worn for extended periods or if the patient is unfamiliar with the system. An incorrectly sized mask can lead to reduced compliance, reduced comfort, and poor patient outcomes. While masks specifically designed for aviators, personal protective equipment (e.g., filter masks), SCUBA masks, or anesthesia administration masks may be tolerable for their intended use, such masks can be undesirably uncomfortable to wear for extended periods (e.g., several hours). This discomfort can reduce patient compliance with treatment, even more so when wearing a mask while sleeping.

[0034] CPAP therapy is highly effective in treating certain respiratory conditions when patients comply with the therapy. However, if the mask is uncomfortable or difficult to use, patients may not comply. Patients are often encouraged to clean their masks regularly, but if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean the mask, which may affect patient compliance.

[0035] Masks for other uses (e.g., aviators) may be unsuitable for use in treating sleep-related respiratory disorders, and masks designed for use in treating sleep-related respiratory disorders may be suitable for other uses.

[0036] For these reasons, patient interfaces that deliver CPAP during sleep form a unique area.

[0037] 2.2.3.1.1 Seal-forming structure The patient interface may include a seal-forming structure. Because the patient interface is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may have a direct impact on the effectiveness and comfort of the patient interface.

[0038] Patient interfaces may 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 patient interface, the seal-forming structure may include a first sub-portion for forming a seal around the left nostril and a second sub-portion for forming a seal around the right nostril. In one form of patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and nose bridge region of the face. In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth region during use, for example, by forming a seal over the lower lip region of the face. In one form of patient interface, the seal-forming structure may include a single element that surrounds both the nostril and mouth regions during use. These different types of patient interfaces may be known by various names depending on their manufacturers, such as nasal masks, full face masks, nasal pillows, nasal puffs, and oronasal masks.

[0039] A seal-forming structure that may be effective in one area of ​​a patient's face may be inappropriate in another area, for example, due to different shapes, structures, variability, and sensitive areas of the patient's face. For example, the seal of swimming goggles that rests on the patient's forehead may be inappropriate for use over the patient's nose.

[0040] A particular seal-forming structure may be designed for mass production so that one design is compatible, 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 the mass-manufactured patient interface, one or both must be adapted to form a seal.

[0041] 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 force is applied to the patient interface with the seal-forming structure engaging against the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or may include a molded or shaped surface of a resilient sealing element constructed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap will form between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0042] Another type of seal-forming structure uses a thin flap seal positioned around the periphery of the mask to provide a self-sealing effect against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming portion, poor fit between the face and mask can require additional force to achieve a seal or the mask may leak. Additionally, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or buckle during use, resulting in leakage.

[0043] Another type of seal-forming structure may include a friction fit element, for example, a friction fit element, although some patients may find this uncomfortable.

[0044] Another form of seal-forming structure may use adhesives to achieve the seal, as some patients find it inconvenient to constantly apply and remove adhesives from their face.

[0045] A range of patient interface seal forming construction techniques are disclosed in patent applications WO1998 / 004,310, WO2006 / 074,513 and WO2010 / 135,785 assigned to ResMed Limited.

[0046] One type of nasal pillow is found on the Adams circuit manufactured by Puritan-Bennett. Another nasal pillow, or nasal puff, is the subject matter of U.S. Patent No. 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0047] ResMed manufactures the following products that incorporate nasal pillows: the SWIFT™ Nasal Pillows Mask, the SWIFT™ II Nasal Pillows Mask, the SWIFT™ LT Nasal Pillows Mask, the SWIFT™ FX Nasal Pillows Mask, and the MIRAGE LIBERTY™ Full Face Mask. Examples of nasal pillow masks are described in patent applications assigned to ResMed, Inc., including International Patent Application WO 2004 / 073,778 (which describes, among other things, various aspects of ResMed's SWIFT™ Nasal Pillows), U.S. Patent Application 2009 / 0044808 (which describes, among other things, various aspects of ResMed's SWIFT™ LT Nasal Pillows), International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describes, among other things, various aspects of ResMed's LIBERTY™ Full Face Mask), and International Patent Application WO 2009 / 052,560 (which describes, among other things, various aspects of ResMed's SWIFT™ FX Nasal Pillows).

[0048] 2.2.3.1.2 Positioning and stabilization The seal-forming structures of patient interfaces used in positive pressure therapy are subject to the corresponding forces of air pressure, which can compromise their seal. Accordingly, various techniques have been used to position and maintain the seal-forming structures in sealing relationship with the appropriate portion of the face.

[0049] One technique involves the use of adhesives (see, for example, U.S. Patent Application Publication No. 2010 / 0000534), but adhesives can be uncomfortable.

[0050] Another technique involves the use of one or more straps and / or stabilizing harnesses, many of which suffer from one or more of the following problems: poor fit, bulky, uncomfortable, and cumbersome.

[0051] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices may be used alone or as part of a system to provide one or more of the above therapies, for example, by actuating the device to generate and deliver airflow to an interface with the airway. The airflow may be pressure-controlled (in the case of respiratory pressure therapy) or flow-controlled (in the case of flow therapy such as HFT). Thus, RPT devices may also be used as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0052] Air pressure generators are known for a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical applications have specific requirements that cannot be met by more common air pressure generators (e.g., the reliability, size, and weight requirements of medical equipment). In addition, even devices designed for medical treatment may suffer from deficiencies related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0053] One example of a special requirement for a particular RPT device is acoustic noise.

[0054] [Table 1]

[0055] One known RPT device used to treat sleep-related respiratory disorders is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another example of an RPT device is a ventilator. Ventilators (e.g., the ResMed STella® series of adult and pediatric ventilators) can provide invasive and non-invasive independent ventilatory support to a variety of patients to treat a number of diseases, including, but not limited to, NMD, OHS, and COPD.

[0056] The ResMed Elisee™ 150 ventilator and ResMed VSIII™ ventilators can provide invasive and non-invasive dependent ventilatory support suitable for adult or pediatric patients for the treatment of multiple illnesses. These ventilators provide volumetric and barometric ventilation modes using single-limb or dual-limb circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) and are configured to deliver airflow to the patient's airway. In some cases, the airflow can be delivered to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface, as described above.

[0057] A device designer may be presented with a myriad of choices. Often, conflicting design criteria may make certain design choices unconventional or unavoidable. Furthermore, the comfort and effectiveness of some embodiments may be highly sensitive to slight changes in one or more parameters.

[0058] 2.2.3.3 Air Circuit An air circuit is a conduit or tube constructed and arranged so that, in use, airflow travels between two components of a respiratory therapy system (e.g., an RPT device and a patient interface). In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single-limb air circuit is used for both inhalation and exhalation.

[0059] 2.2.3.4 Humidifier Airflow delivery without humidification can lead to dryness of the airway. When a humidifier is used with an RPT device and patient interface, humidified gas is produced, minimizing drying of the nasal mucosa and increasing comfort of the patient's airway. Additionally, in cooler climates, warm air applied within the patient interface and to the facial area surrounding the patient interface is generally more comfortable than cool air.

[0060] Although various artificial humidification devices and systems are known, these may not meet the special requirements of a medical humidifier.

[0061] Medical humidifiers are typically used in locations where patients may be sleeping or resting (e.g., hospitals) to increase the humidity and / or temperature of an air stream relative to the ambient air when needed. Bedside medical humidifiers may be compact. Medical humidifiers may be configured to only humidify and / or heat the air stream delivered to a patient, without humidifying and / or heating the patient's immediate environment. For example, while room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can humidify the air inhaled by a patient, these systems may also humidify and / or heat the entire room, which may cause discomfort to the occupants. Furthermore, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0062] While many medical humidifiers are known, these humidifiers suffer from one or more drawbacks: some medical humidifiers provide insufficient humidification, while others are difficult or inconvenient for patients to use.

[0063] 2.2.3.5 Oxygen Source Experts in the field have long recognized that exercise for patients with respiratory failure can have long-term benefits that slow disease progression, improve quality of life, and extend the patient's lifespan. However, most stationary forms of exercise, such as treadmills and stationary bikes, are too strenuous for these patients. Therefore, the need for mobility has long been recognized. Until recently, this mobility was facilitated using cylinders or small compressed oxygen tanks mounted on carts with trolley wheels. These tanks have the disadvantage of being limited in the amount of oxygen they can hold and heavy (approximately 50 pounds when worn).

[0064] Oxygen concentrators have been used to provide oxygen for respiratory therapy for approximately 50 years. Traditional oxygen concentrators are heavy and bulky, making it difficult and impractical to carry them while performing normal ambulatory activities. Recently, manufacturers of large stationary oxygen concentrators have begun developing portable oxygen concentrators (POCs). The advantage of POCs is that they can produce a theoretically unlimited supply of oxygen. Making these devices compact for mobility requires a diverse system for producing condensed oxygen-enriched gas. To minimize weight, size, and power consumption, POCs attempt to utilize the oxygen they produce as efficiently as possible. This is achieved by delivering oxygen in a series of pulses, with each bolus timed to coincide with the onset of inspiration. This mode of therapy is known as pulsed oxygen delivery (POD) or demand mode, as opposed to traditional continuous-flow delivery, which is more suited to stationary oxygen concentrators.

[0065] 2.2.3.6 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant" (e.g., whether the patient is using their RPT device in accordance with one or more "compliance rules"). An example compliance rule for CPAP therapy may require a patient to use the RPT device for at least four hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine patient compliance, a provider of the RPT device (e.g., a healthcare provider) may manually obtain data describing the patient's therapy with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. If the healthcare provider determines that the patient used their RPT device in accordance with the compliance rules, the healthcare provider may notify a third party that the patient is compliant.

[0066] There may be other aspects of a patient's therapy that benefit from communication of therapy data to third parties or external systems.

[0067] Existing processes for communicating and managing such data can be one or more of: costly, time consuming, and error prone.

[0068] 2.2.3.7 Ventilation technology Some forms of treatment systems may include a vent to push out exhaled carbon dioxide, which may allow gas flow from an interior space of the patient interface (e.g., a plenum chamber) to an exterior of the patient interface (e.g., ambient).

[0069] 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, resulting in insufficient pumping. Some vents may disrupt the sleep of the patient's bed companion 1100, for example, due to noise or concentrated airflow.

[0070] ResMed Limited has developed several 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. 2009 / 0050156, U.S. Patent Application Publication No. 2009 / 0044808.

[0071] [Table 2]

[0072] [Table 3]

[0073] 2.2.4 Screening, diagnostic, and surveillance systems Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases and typically requires specialized clinical staff for system application. PSG typically involves placing 15–20 contact sensors on the patient to record various body signals, including electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), and electromyography (EMG). PSG for sleep-disordered breathing requires the patient to be observed in a clinic for two nights: the first night for pure diagnosis and the second night for titration of treatment parameters by the clinician. Therefore, PSG is expensive and inconvenient. Screening, diagnosis, and monitoring of sleep-disordered breathing are particularly unsuitable for home use.

[0074] In general, screening and diagnosis involve identifying disease through signs and symptoms. Screening typically produces a true / false result indicating whether a patient's SDB warrants further investigation, while diagnosis often produces clinically actionable information. Screening and diagnosis tend to be one-time procedures, whereas monitoring the progression of disease can continue indefinitely. Some screening / diagnostic systems are adapted solely for screening / diagnosis, while some can also be used for monitoring.

[0075] A clinical expert may adequately screen, diagnose, or monitor a patient based on visual observation of the PSG signal. However, there are situations where a clinical expert is unavailable or cannot be paid for. Different clinical experts may have different opinions about the patient's condition. Furthermore, a given clinical expert may apply different criteria each time. Summary of the Invention

[0076] The present technology relates to providing medical devices for use in screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory diseases, which medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0077] A first aspect of the present technology relates to devices used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disease.

[0078] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of respiratory disorders.

[0079] An aspect of certain forms of the present technology is to provide methods and / or devices for improving patient compliance with respiratory therapy.

[0080] One form of the present technology comprises a positioning and stabilizing structure configured to provide a force to hold a seal-forming structure in a therapeutically effective position on a patient's head, the positioning and stabilizing structure including at least one flat strap.

[0081] One form of the present technology involves a patient interface including a plenum chamber, a seal-forming structure, and a positioning and stabilizing structure.

[0082] One aspect of the present technology comprises a patient interface including a plenum chamber pressurizable to a therapeutic pressure of at least 4 cmH2O above ambient air pressure. The plenum chamber includes at least one plenum chamber inlet port sized and configured to receive a flow of air at the therapeutic pressure for breathing by the patient. The patient interface further includes a seal-forming structure configured 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 such that the flow of air at said therapeutic pressure is delivered to at least the entrances of the patient's nares. The seal-forming structure is configured and arranged to maintain said therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use. The patient interface also includes a positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0083] 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.

[0084] In one form, there are at least two versions or styles of each modular element that can be used interchangeably to form different modular assemblies.

[0085] One form of the present technology is a respiratory therapy system comprising: a patient interface; an air circuit configured to removably couple to the patient interface; a radio frequency identification (RFID) tag associated with the patient interface, the RFID tag configured to store information related to the patient interface; an antenna; and a transceiver that can be configured to wirelessly receive the information stored on the RFID tag and transmit the information to a controller when the air circuit can be coupled to the patient interface.

[0086] In one aspect of the present technology, at least one of the antenna or the transceiver may be disposed on an adapter configured to couple the air circuit to the patient interface.

[0087] In another aspect, at least one of the antenna or transceiver is located at the proximal end of the air circuit.

[0088] In one form, at least one of the antenna or transceiver may be housed within a cover located at the proximal end of the air circuit.

[0089] 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.

[0090] In aspects, the controller may be incorporated as part of a respiratory pressure therapy device.

[0091] In one aspect, the controller can be configured to automatically configure at least one setting of the respiratory pressure therapy device based on information related to the patient interface received from the transceiver.

[0092] In aspects, the antenna may be a multi-directional antenna with multiple antennas oriented at different angles relative to one another.

[0093] In another aspect, an air circuit for a respiratory therapy system can include a proximal end and a distal end, the proximal end can be configured to removably couple to a patient interface and the distal end can be configured to removably couple to a respiratory pressure therapy device, and a multidimensional antenna disposed in a proximal region of the air circuit, the multidimensional antenna comprising multiple antennas oriented at different angles relative to one another.

[0094] In an embodiment, the multi-dimensional antenna may comprise two antennas.

[0095] In the configuration, the two antennas may be oriented at right angles to each other.

[0096] In a further aspect, the multi-dimensional antenna comprises a three or more dimensional antenna.

[0097] In some embodiments, the plurality of antennas may comprise at least a first antenna and a second antenna, and the first antenna and the second antenna may be oriented at an angle of between about 30 degrees and about 120 degrees relative to each other.

[0098] In an embodiment, the multiple antennas may be set at frequencies between about 10 MHz and about 12 GHz.

[0099] In a further aspect, a respiratory therapy system includes a respiratory pressure therapy device and a controller configured to perform operations including receiving information about the patient interface from an RFID tag associated with the patient interface and performing a responsive action based at least in part on the received information about the patient interface, the responsive action being configuring settings of the respiratory pressure therapy device, generating an indication that a new patient interface or a new cushion for the patient interface is recommended, generating an indication that a different size or type of patient interface or cushion is recommended, generating an indication that an air circuit is not coupled to the patient interface or is improperly coupled to the patient interface, or and transmitting information about the patient interface to a cloud server.

[0100] In aspects, the controller may be incorporated as part of a respiratory pressure therapy device.

[0101] In some embodiments, the received information regarding the patient interface may include one or more of a type or size of the patient interface, a type or size of the cushion, a manufacturing batch identification number or serial identification number of the patient interface, a timestamp, a date of use, or a period of use of the patient interface.

[0102] In aspects, information regarding the patient interface may be received at the start of a therapy session administered by the respiratory therapy system.

[0103] 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.

[0104] In some forms, the frequency with which information regarding the patient interface is received may increase if irregularities in the received information are detected.

[0105] 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 including a tubular body configured to transport pressurized therapeutic air between a proximal end and a distal end of the tubular body, the proximal end configured to connect to a patient interface and the distal end configured to connect to an air delivery tube, and a sensor configured to generate a signal based on air passing through the proximal end for diagnosing and / or treating a respiratory disorder.

[0106] 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 including a tubular body configured to transport pressurized therapeutic air between a proximal end and a distal end of the tubular body, the proximal end configured to connect to a patient interface and the distal end configured to connect to an air delivery tube, and a sensor configured to generate a signal indicative of a patient's sleeping position.

[0107] 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 comprising: a tubular body configured to transport pressurized therapeutic air between a proximal end and a distal end of the tubular body, the proximal end configured to connect to a patient interface and the distal end configured to connect to an air delivery tube; and a sensor configured to generate a signal indicative of exhaled gases and / or biomarkers of gases exhaled by the patient.

[0108] 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 including a proximal end and a distal end, the proximal end configured to removably couple to a patient interface and the distal end configured to removably couple 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.

[0109] In one example, the sensor includes a pressure sensor.

[0110] In one example, the sensor includes an acceleration sensor.

[0111] In one example, the sensor is a CO2 sensor.

[0112] In one example, the CO2 sensor is configured to detect CO2 accumulation, rebreathing CO2 levels, and / or respiratory comfort.

[0113] In one example, the CO2 sensor is configured to be placed between the patient and the ventilation port of the patient interface.

[0114] In one example, the CO2 sensor is configured to detect end-tidal CO2.

[0115] In one example, the sensor is a volatile organic compound (VOC) sensor configured to detect biomarkers in the patient's breath.

[0116] In one example, the sensor is a CO2 sensor and / or a volatile organic compound (VOC) sensor, and the CO2 sensor and / or the (VOC) sensor is configured to perform a pre-treatment analysis before the pressurized therapeutic air is delivered to the patient interface.

[0117] In one example, the tubular body comprises a flexible material.

[0118] In one example, the inner diameter of the tubular body is about 10-15 mm.

[0119] In one example, the inside diameter of the tubular body is 12 mm.

[0120] In one example, the tubular body has a length of about 8.5 to 10 cm.

[0121] In one example, the length is about 8.5 cm.

[0122] In one example, the exterior surface of the tubular body includes or is covered with a woven material.

[0123] In one example, the tubular body includes a helix.

[0124] In one example, the proximal end includes a mechanical connector configured to connect to a patient interface.

[0125] In one example, the mechanical connector comprises a circlip having a pair of opposing clips configured to connect to the patient interface.

[0126] In one example, the mechanical connector includes an isotaper configured to connect with the patient interface in an interference or friction fit.

[0127] In one example, the air adapter tube further includes a flexible printed circuit at the proximal end that supports the sensor.

[0128] In one example, the flexible circuit includes an antenna, which may be an NFC antenna.

[0129] In one example, the antenna is configured to wirelessly transmit collected sensor data to an external device, including a smartphone or a flow generator.

[0130] In one example, the flexible printed circuit includes at least one wire connection point connecting the antenna to at least one wire extending along and from the tubular body.

[0131] In one example, the flexible printed circuit includes straight sections that support electronic components and at least one flexible bend section between the straight sections.

[0132] In one example, one of the electronic components is a pressure sensor and another of the electronic components is an acceleration sensor configured to generate a signal indicative of the patient's sleeping position.

[0133] In one example, the electronics include one or more sensors configured to generate a signal indicative of the exhaled breath and / or biomarkers indicative of the patient's health.

[0134] In one example, the one or more sensors include a CO2 sensor or a volatile organic compound (VOC) sensor.

[0135] In one example, the air adapter tube further includes a temperature sensor configured to generate a signal indicative of the temperature within the tubular body.

[0136] In one example, the air adapter tube further includes a first adapter element at the proximal end, the first adapter element supporting the sensor.

[0137] In one example, the first adapter element includes an outer cylindrical surface with a port, and the sensor protrudes radially inward and / or through the port.

[0138] In one example, the air adapter tube further includes silicone to seal the port adjacent to the sensor.

[0139] In one example, the air adapter tube further includes a second adapter element that connects and seals with the film and helix of the tubular body.

[0140] In one example, the air adapter tube further includes a cuff portion connected to the first adapter element, the first adapter element and the cuff portion forming an annular space configured to receive a flexible printed circuit supporting the sensor.

[0141] 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 adhesive.

[0142] In one example, the air adapter tube further includes a ventilation opening along the circumference of the first adapter element.

[0143] In one example, the air adapter tube further includes a water-resistant pressure balance membrane disposed at the vent and configured to regulate a differential pressure at the proximal end.

[0144] In one example, the air adapter tube further includes an electrical connector disposed at the distal end of the tubular body, the electrical connector configured to electrically connect to a corresponding electrical connector on the heated air delivery tube.

[0145] In one example, the electrical connector includes a lead frame configured to transmit power and / or signals.

[0146] 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 on the heated air delivery tube.

[0147] 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.

[0148] In one example, the air adapter tube further includes a mechanical connector disposed at the distal end of the tubular body, the mechanical connector configured to mechanically connect to a corresponding mechanical connector on the heated air delivery tube.

[0149] In one example, the air adapter tube further includes a power source configured to provide power to the sensor or the flexible printed circuit.

[0150] In one example, the air adapter tube further includes a plurality of sensors, including at least a 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 the patient's sleep posture. The third sensor is configured to generate a signal indicative of breath and / or biomarkers of gas exhaled by the patient before treatment is administered.

[0151] In one example, the air adapter tube further includes a first electrical connection configured to couple with a first wire configured to provide power to the air delivery tube, and a second electrical connection configured to couple with a second wire configured to transmit and receive data to and from the air delivery tube.

[0152] In one example, the antenna is a multi-directional antenna comprising multiple antennas oriented at different angles relative to one another.

[0153] In one example, the multi-directional antenna comprises two antennas.

[0154] In one example, the plurality of antennas comprises at least a first antenna and a second antenna, the first antenna and the second antenna oriented at an angle between about 30 degrees and about 120 degrees relative to each other.

[0155] In one example, the multiple antennas are set to frequencies between about 10 MHz and about 12 GHz.

[0156] In one example, the sensor is supported on the proximal end of the air adapter tube and / or on its tubular body.

[0157] Another aspect of one form of the present technology relates to a medical procedure device for diagnosing and / or treating a patient having a respiratory disorder, including 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 the pressurized breathable air from the flow generator toward the patient interface, and an air adapter tube.

[0158] In one example, the flow generator is configured to be controlled based on the output from the sensor.

[0159] Another aspect of one form of the present technology relates to a method for diagnosing and / or treating a patient, 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.

[0160] 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 control when a sensor is configured to sense a physical quantity.

[0161] In one example, the sensor is controlled based on the determined position of the patient. In one example, the sensor is controlled to sense the physical quantity before positive air pressure is supplied to the air adapter tube.

[0162] In one example, the sensor is controlled to sense the physical quantity based on determining that positive air pressure is not being supplied to the air adapter tube.

[0163] 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 altering at least one treatment parameter based on a signal generated by the sensor.

[0164] In one example, the system further includes a patient interface that includes an RFID tag that includes data received by the antenna of the air adapter tube.

[0165] The above-described methods, systems, devices, and apparatus may be implemented to improve the functionality of processors of special purpose computers, respiratory monitors, and / or respiratory treatment devices, etc. Additionally, the above-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.

[0166] Of course, some of the aspects may form sub-aspects of the technology, and various of the sub-aspects and / or aspects may be combined in various ways to form additional aspects or sub-aspects of the technology.

[0167] Other features of the technology will become apparent upon consideration of the information contained in the following detailed description, summary, drawings, and claims.

[0168] The present technology is illustrated by way of example, and not limitation, in the drawings in which like reference numerals refer to like elements, including the following elements: [Brief explanation of the drawings]

[0169] [Figure 1A] 1 illustrates various configurations of a respiratory therapy system in use. [Figure 1B] 1 illustrates various configurations of a respiratory therapy system in use. [Figure 1C] 1 illustrates various configurations of a respiratory therapy system in use. [Figure 2] 1 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology. [Figure 3A] 1 shows a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology. The upstream and downstream directions are shown with reference to the blower and the patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items in the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. [Figure 3B] FIG. 1 shows a schematic diagram of the electrical components of an RPT device in accordance with one form of the present technology. [Figure 3C] 1 shows a schematic diagram of an algorithm implemented within an RPT device in accordance with one form of the present technology; [Figure 4A] 1 shows 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 to the patient's mouth. [Figure 4B] 1 illustrates 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. [Figure 4C] 4B. FIG. 4C shows a perspective view of a tube that can be used with either the cushion of FIG. 4A or the cushion of FIG. 4B. [Figure 4D] FIG. 4C shows a perspective view of a rigidiser arm that can be used with either the cushion of FIG. 4A or the cushion of FIG. 4B. [Figure 4E] 4B shows a perspective view of a headgear strap that can be used with the cushion of FIG. 4A. [Figure 4F] FIG. 4C shows a perspective view of a headgear strap that can be used with the cushion of FIG. 4B. [Figure 4G] 4D. FIG. 4E shows a front view of a pair of sleeves that are removably attached to either the tube of FIG. 4C or the rigidiser arm of FIG. 4D. [Figure 4H] FIG. 4E shows a front view of a full sleeve that is removably attached to the rigidiser arm of FIG. 4D. [Figure 4I] FIG. 4E shows a front perspective view of yet another alternative full sleeve removably attached to the rigidiser arm of FIG. 4D. [Figure 4J] 4G is a front view of a patient wearing the cushion of FIG. 4A to which the tube of FIG. 4C, the headgear straps of FIG. 4E, and the sleeve of FIG. 4G are connected. [Figure 4K] FIG. 4H is a front view of a patient wearing the cushion of FIG. 4A connected to the rigidiser arm of FIG. 4D, the headgear strap of FIG. 4E, and the sleeve of FIG. 4H. [Figure 4L] FIG. 4F is a front view of a patient wearing the cushion of FIG. 4B connected to the conduit headgear of FIG. 4C and the headgear straps of FIG. 4F. [Figure 4M] FIG. 4I is a front view of a patient wearing the cushion of FIG. 4B connected to the rigidizer arm of FIG. 4D, the headgear strap of FIG. 4F, and the sleeve of FIG. 4I. [Figure 4N] 4A shows an isolated perspective view of the vent of FIG. 4L. [Figure 4O]4A shows an isolated perspective cutaway view of a portion of the air circuit of FIG. 4M. [Figure 4P] 1 shows a schematic diagram illustrating possible combinations of patient interfaces. [Figure 5A] 1 shows a schematic diagram of a medical system according to an aspect of the present disclosure. [Figure 5B] 1 shows a schematic diagram of an alternative medical system according to an aspect of the present disclosure. [Figure 6A] 1 shows a perspective view of a proximal portion of an air circuit according to aspects of the present disclosure. [Figure 6B] 1 shows a perspective view of a proximal portion of an air circuit according to aspects of the present disclosure. [Figure 6C] 6C illustrates a front view of the circuit board shown in FIG. 6B according to an embodiment of the present disclosure. [Figure 7A] FIG. 1 illustrates a front view of an exemplary patient interface according to aspects of the present disclosure. [Figure 7B] 1 illustrates a side view of an exemplary patient interface according to aspects of the present disclosure. [Figure 8A] 10 illustrates a rear view of an alternative exemplary patient interface according to aspects of the present disclosure. [Figure 8B] 10A-10C illustrate top views of alternative exemplary patient interfaces according to aspects of the present disclosure. [Figure 9A] 1 illustrates various configurations of two or more antennas according to an embodiment of the present disclosure. [Figure 9B] 1 illustrates various configurations of two or more antennas according to an embodiment of the present disclosure. [Figure 9C] 1 illustrates various configurations of two or more antennas according to an embodiment of the present disclosure. [Figure 9D] 1 illustrates various configurations of two or more antennas according to an embodiment of the present disclosure. [Figure 10A] 1 illustrates various configurations between various patient interfaces and the air circuit. [Figure 10B] 1 illustrates various configurations between various patient interfaces and the air circuit. [Figure 10C] 1 illustrates various configurations between various patient interfaces and the air circuit. [Figure 10D]1 illustrates various configurations between various patient interfaces and the air circuit. [Figure 11]

[0033] Fig. 13 shows a perspective view of an air adapter tube from the distal end in accordance with an example of the present technology. [Figure 12] 12 shows another perspective view of the air adapter tube of FIG. 11 as viewed from the distal end. [Figure 13] 12 shows another perspective view of the air adapter tube of FIG. 11, viewed from the proximal end. [Figure 14] 12 shows another perspective view of the air adapter tube of FIG. 11, viewed from the proximal end. [Figure 15] FIG. 12 shows a perspective view of the air adapter tube of FIG. 11 connected to an air delivery tube according to an example of the present technology. [Figure 16] FIG. 12 shows another perspective view of the air adapter tube of FIG. 11 connected to an air delivery tube according to an example of the present technology. [Figure 17] FIG. 12 shows a perspective view of the air adapter tube of FIG. 11 connected to an air delivery tube according to an example of the present technology. [Figure 18] FIG. 12 shows another perspective view of the air adapter tube of FIG. 11 connected to an air delivery tube according to an example of the present technology. [Figure 19] FIG. 12 shows another perspective view of the air adapter tube of FIG. 11 connected to an air delivery tube according to an example of the present technology. [Figure 20] 12 shows an exploded perspective view of the air adapter tube of FIG. 11 according to an example of the present invention. [Figure 21] 12 shows another exploded perspective view of the air adapter tube of FIG. 11 according to an example of the present invention. [Figure 22] 12 shows a partial cross-sectional view of the air adapter tube of FIG. 11 according to an example of the present invention. [Figure 23] 12 illustrates an exploded, partial cross-sectional view of the air adapter tube of FIG. 11 according to an example of the present invention. [Figure 24] 12 illustrates another exploded partial cross-sectional view of the air adapter tube of FIG. 11 according to an example of the present invention. [Figure 25]

[210] Fig. 11 shows an exploded perspective view of an end of an air delivery tube according to an example of the present technology. [Figure 26] FIG. 26 shows another exploded perspective view of the end of the air delivery tube of FIG. 25 in accordance with an example of the present technology. [Figure 27] FIG. 12 shows a perspective view of the proximal end of the air adapter tube of FIG. 11 with the cuff portion removed in accordance with an example of the present technology. [Figure 28] FIG. 12 shows another perspective view of the proximal end of the air adapter tube of FIG. 11 with the cuff portion removed in accordance with an example of the present technology. [Figure 29] FIG. 12 shows another perspective view of the proximal end of the air adapter tube of FIG. 11 with the cuff portion removed in accordance with an example of the present technology. [Figure 30] FIG. 12 shows an end view of the proximal end of the air adapter tube of FIG. 11 with the cuff portion removed in accordance with an example of the present technology. [Figure 31] 12 shows a partial cross-sectional view of the air adapter tube of FIG. 11 according to an example of the present invention. [Figure 32] 12 shows a cross-sectional view of the air adapter tube of FIG. 11 with the cuff portion removed, according to an example of the present invention. [Figure 33] FIG. 12 shows a perspective view of the air adapter tube of FIG. 11 connected to an air delivery tube according to an example of the present technology. [Figure 34] 34 shows a cross-sectional view taken along line 34-34 of FIG. [Figure 35] 35 shows a cross-sectional view taken along line 35-35 of FIG. [Figure 36] FIG. 12 shows a cross section of the air adapter tube of FIG. 11 connected to a patient interface according to an example of the present technology. [Figure 37] FIG. 12 shows a cross section view of the air adapter tube of FIG. 11 being manually removed from the patient interface in accordance with an example of the present technology. [Figure 38]

[0023] Fig. 1 shows a top view of a flexible printed circuit board according to an example of the present technology. [Figure 39] FIG. 12 shows a block diagram of the air adapter tube of FIG. 11 in accordance with an example of the present technology. DETAILED DESCRIPTION OF THE INVENTION

[0170] Before describing the present technology in further detail, it is to be understood that the present technology is not limited to particular examples described herein, as such may vary, and it is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples described herein, and is not intended to be limiting.

[0171] The following description is provided in connection with various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or the other examples. In addition, any single feature or combination of features in any example may constitute an additional example.

[0172] Reference will now be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or like reference numbers refer to the same or like parts in the figures. The term "distal" refers to the part farthest from a user (e.g., a patient). In contrast, the term "proximal" refers to the part closest to the user.

[0173] Both the foregoing general description and the following detailed description are exemplary and explanatory and are not limiting of the features recited in the claims. As used herein, the terms "comprises," "comprising," "having," "including," or other variations thereof, are intended to be non-exclusive inclusions, such that a process, method, article, or apparatus consisting of a list of elements does not include only those elements, but may also include other elements not expressly listed or inherent to such process, method, article, or apparatus. In this disclosure, relative terms such as "about," "substantially," "generally," and "approximately" are used to indicate that a stated value or characteristic may vary by ±10%.

[0174] 5.1 Therapy In one form, the present technology includes a method of treating a respiratory disorder comprising applying positive pressure to the entrance of the airways of a patient 1000.

[0175] In a particular example of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0176] In certain instances of the present technology, mouth breathing is restricted, limited, or prevented.

[0177] 5.2 Respiratory Therapy Systems In one form, the present technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0178] 1A shows a respiratory therapy system including a patient 1000 wearing a patient interface 3000 in the form of nasal pillows and receiving a supply of air at positive pressure from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 through an air circuit 4170. A bed companion 1100 is also shown. The patient is sleeping in a supine sleeping position.

[0179] 1B shows an alternative configuration of a respiratory therapy system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives air at positive pressure supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0180] 1C shows a further alternative configuration of a respiratory therapy system including a patient 1000 wearing a patient interface 3000 in the form of a full face mask that receives air at positive pressure supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a lateral sleeping position.

[0181] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute, in whole or in part, any of one or more algorithms 4300, e.g., methods, described herein. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, for example, to treat one or more of the respiratory conditions described elsewhere herein.

[0182] In one form, the RPT device 4000 is constructed and arranged to deliver airflow 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.

[0183] 1A, 1B, and 1C, the patient 1000 may use the respiratory therapy system in a variety of positions. Thus, for example, the position of the patient interface 3000 relative to the air circuit 4170 or other aspects of the respiratory therapy system may change during use.

[0184] 5.3 Patient Interface As shown in FIG. 2 , a non-invasive patient interface 3000 in accordance with one aspect of the present technology includes functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a ventilation opening 3400, a form of connection port 3600 for connecting to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical elements. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is positioned to surround an entrance to the patient's 1000 airway so as to maintain positive pressure at the entrance(s) to the patient's airway. Thus, the sealed patient interface 3000 is suitable for delivery of positive pressure therapy.

[0185] 5.3.1 Plenum chamber The plenum chamber 3200 has a periphery shaped to be complementary to the surface contours of an average human face in the area where a seal is formed in use. In use, the periphery of the plenum chamber 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 can extend around substantially the entire circumference of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single, homogenous sheet of material.

[0186] In certain forms of the present technology, the plenum chamber 3200 does not cover the patient's eyes when in use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. Such forms may improve treatment compliance, often resulting in less intrusiveness and / or greater wearer comfort.

[0187] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). The use of a transparent material may reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of a transparent material may help the clinician see the placement and function of the patient interface.

[0188] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material, which can make the patient interface less intrusive and help improve compliance with treatment.

[0189] In some forms, the plenum chamber 3200 is constructed from a rigid material, such as polycarbonate, which may support a seal-forming structure.

[0190] In some forms, the plenum chamber 3200 is constructed of a flexible material (e.g., made from a soft, flexible, resilient material such as silicone, fabric, foam, etc.). For example, in various instances, they may be formed from 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 chamber 3200 may be formed from 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 chamber 3200 may be formed from a material having a Young's modulus of 0.4 MPa or less, such as between 0.4 MPa and 0.3 MPa. One example of such a material is silicone.

[0191] 5.3.1.1 Multiple openings 4A and 4B, different plenum chambers 3200-1, 3200-2 may be formed as part of multi-aperture cushions 3050-1, 3050-2. In the illustrated embodiment, cushions 3050-1, 3050-2 each include three apertures, although alternative cushions may be formed with more or fewer apertures.

[0192] In some configurations, different openings may serve different functions, for example, some openings may be only intake openings and other openings may be only exhaust openings.

[0193] In other configurations, at least one opening may serve two different functions, for example, one opening may act as both an inlet and an outlet during the same breathing cycle.

[0194] The multiple openings may allow for various configurations of air supply to the plenum chambers 3200-1, 3200-2. For example, depending on the patient's needs and / or comfort, the patient may use a given cushion 3050-1, 3050-2 in a "tube up" configuration (e.g., using conduit headgear as described below) or a "tube down" configuration (e.g., using a single conduit in front of the patient's face).

[0195] 5.3.1.1.1 Oronasal mask 4A, the plenum chamber 3200-1 includes a pair of plenum chamber inlet ports 3254-1 that can be used to deliver gases into and / or out of the plenum chamber 3200-1. The plenum chamber inlet ports 3254-1 can be located on opposite sides (e.g., left and right sides) of the plenum chamber 3200-1.

[0196] In some forms, the plenum chamber 3200-1 may also include at least one ventilation opening 3402-1 (see, for example, FIG. 4A). The ventilation opening 3402-1 may be disposed at the center of the plenum chamber 3200-1. For example, the ventilation opening 3402-1 may be disposed between the plenum chamber inlet ports 3254-1.

[0197] In some forms, the plenum chamber 3200-1 may include a pair of grooves 3266-1. Each groove 3266-1 may be located proximate one of the plenum chamber inlet ports 3254-1. Each groove 3266-1 may form a partially recessed surface.

[0198] 5.3.1.1.2 Nasal masks 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. In the following, only some similarities and differences between the plenum chamber 3200-1 and the plenum chamber 3200-2 will be described.

[0199] 4B, the plenum chamber 3200-2 includes a pair of plenum chamber inlet ports 3254-2, which can be used to deliver gases into and / or out of the plenum chamber 3200-2. The plenum chamber inlet ports 3254-2 can be located on opposite sides (e.g., left and right sides) of the plenum chamber 3200-2.

[0200] In some forms, the plenum chamber 3200-2 may also include at least one ventilation opening 3402-2 (see, for example, FIG. 4B). The ventilation opening 3402-2 may be disposed at the center of the plenum chamber 3200-2. For example, the ventilation opening 3402-2 may be disposed between the plenum chamber inlet ports 3254-2.

[0201] In some embodiments, the plenum chamber 3200-2 may include a pair of grooves 3266-2. Each groove 3266-2 may be positioned proximate one of the plenum chamber inlet ports 3254-2. Each groove 3266-2 may form a partially recessed surface.

[0202] 5.3.2 Positioning and stabilizing structures In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate potentially destructive effects on the patient interface 3000 (e.g., due to tube drag or inadvertent interference with the patient interface).

[0203] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to be worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low 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 strap with a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0204] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a supine sleep position with the posterior region of the patient's head resting on a pillow.

[0205] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so that it is not excessively large or bulky in size that would interfere with a patient sleeping in a lateral sleeping position with the lateral section region of the patient's head resting on a pillow.

[0206] In one form of the present technology, the positioning and stabilizing structure 3300 includes a decoupling portion located between an anterior portion of the positioning and stabilizing structure 3300 and a posterior portion of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and can be a flexible or pliable strap, for example. The decoupling portion is constructed and positioned such that when a patient lies down with their head on a pillow, the presence of the decoupling portion prevents posterior forces from being transmitted along the positioning and stabilizing structure 3300 and disrupting the seal.

[0207] In one form of the present technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient-contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0208] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) strap. For example, the strap can be configured to be tensioned in use to direct a force that seals the seal-forming structure against a portion of the patient's face. In one example, the strap can be configured as a tie.

[0209] In one form of the present technology, the positioning and stabilizing structure includes a first tie constructed and arranged such that, in use, at least a portion of its lower edge passes over and moves to a superior-temporal point of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0210] In one form of the present technology, suitable for a nasal-only or full-face mask, the positioning and stabilizing structure includes a second tie constructed and arranged such that, in use, at least a portion of its upper edge passes below the inferior ear base point on the underside of the patient's head and covers or rests below the occipital bone of the patient's head.

[0211] In one form of the present technology, suitable for a nasal-only or full-face mask, the positioning and stabilizing structure includes a third tie constructed and arranged to interconnect the first tie and the second tie in a manner that reduces the tendency of the first tie and the second tie to move apart.

[0212] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes straps that are bendable, e.g., non-rigid. An advantage of this embodiment is that the straps are more comfortable when the patient lies down to sleep.

[0213] In a particular form of the present technology, the positioning and stabilizing structure 3300 includes straps configured to be breathable to allow water vapor to pass therethrough.

[0214] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, with each positioning and stabilizing structure 3300 configured to provide a holding force to accommodate a range of different sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large sized heads but not for small sized heads, and another form that is suitable for small sized heads but not for large sized heads.

[0215] 5.3.2.1 Conduit headgear 5.3.2.1.1 Conduit-type headgear tubes

[00130] In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more headgear tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example, via the plenum chamber 3200 and the seal-forming structure 3100. In the form of the present technology shown in FIG. 4J, 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 position and stabilize the seal-forming structure 3100 of the patient interface 3000 over the appropriate portion of the patient's face (e.g., nose and / or mouth) during use. This allows the conduit of the air circuit 4170 providing the pressurized air flow to be connected to the connection port 3600 of the patient interface in a position other than in front of the patient's face.

[0216] 4J, the positioning and stabilizing structure 3300 includes two tubes 3350, each positioned on a different side of the patient's head in use, extending through a respective cheek area and above a respective ear (above the upper ear base of the patient's head) to an elbow 3610 at the top of the patient's 1000's head. This form of the technology can be advantageous because when the patient sleeps with their head reclined, and one of the tubes 3350 is compressed, blocking or partially blocking gas flow along the tube 3350, the other tube 3350 remains open and provides pressurized gas to the patient. In other examples of the technology, the patient interface 3000 may include a different number of tubes, for example one tube, or three or more tubes.

[0217] In examples where the patient interface has one tube 3350, the single tube 3350 is positioned on one side of the patient's head in use (e.g., over the cheek region) and the strap forms part of the positioning and stabilising structure 3300 and is positioned on the other side of the patient's head in use (e.g., over another region) 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.

[0218] In one form, the tube 3350 may be at least partially stretchable so that the tube 3350 and straps can be adjusted to substantially equal lengths when worn by a patient, which may allow for substantially symmetrical adjustment between the tube 3350 and the straps so that the seal-forming structure remains substantially centered.

[0219] In the form of the technology shown in FIG. 4J, two tubes 3350 are fluidly connected at their upper ends to one another and to a connection port 3600. In some examples, the two tubes 3350 are integrally formed, while in other examples, the tubes 3350 are formed separately but may be connected during use and disconnected, for example, for cleaning or storage. When separate tubes are used, they may be indirectly connected together, for example, each connected to a T-connector. The T-connector has two arms / branches, each fluidly connectable to a respective one of the tubes 3350. Additionally, the T-connector may have a third arm or opening that provides a connection port 3600 for fluidly connecting to the air circuit 4170 during use. The opening may be an inlet 3332 (see, e.g., 4C) for receiving a flow of pressurized air.

[0220] In some forms, the third arm of the T-shaped connector can be substantially perpendicular to each of the first two arms.

[0221] In some forms, the third arm of the T-shaped connector may be formed at an angle to each of the first two arms.

[0222] In some configurations, 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 mimic the shape of the patient's head to accommodate the shape of the patient's head.

[0223] In some forms, at least one of the arms of the T-connector (or Y-connector) may be flexible, which may allow the connector to flex based on the shape of the patient's head and / or forces in the positioning and stabilizing structure 3300.

[0224] In some forms, at least one of the arms of the T-connector (or Y-connector) may be at least partially rigidizer, which can help maintain the shape of the connector so that bending the connector does not close the airflow path.

[0225] The tube 3350 may be formed of a flexible material, such as an elastomer, such as silicone or TPE, and / or one or more fabrics and / or foam materials. The tube 3350 may have a preformed shape and may bend or move to another shape when force is applied, but may return to its original preformed shape when force is removed. The tube 3350 may have a generally arcuate or curved shape that approximates the contours of the patient's head between the crown and the nasal or oral region.

[0226] In some examples, the tube(s) 3350 are crush resistant to prevent jamming when compressed during use, such as when compressed between the patient's head and a pillow, especially when there is only one tube 3350. The tube 3350 may be formed to have sufficient structural rigidity to resist crushing and may be constructed as in U.S. Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0227] Each tube 3350 may be configured to receive airflow from the connection port 3600 at the top of the patient's head and deliver the airflow to the seal-forming structure 3100 at the entrance to the patient's airway. In the example shown in FIG. 4J , each tube 3350 extends from the plenum chamber 3200 through the patient's cheek region and is positioned on a path from above the patient's ear to the elbow 3610 in use. For example, a portion of each tube 3350 near the plenum chamber 3200 may overlie the maxillary region of the patient's head in use. Another portion of each tube 3350 may cover the region of the patient's head above the base of the ear at the top of the patient's head. Each of the one or more tubes 3350 may be positioned over the patient's sphenoid and / or temporal bone, and one or both of the patient's frontal and parietal bones. The elbow 3610 may be positioned over the patient's parietal bone, over the frontal bone, and / or their junction (e.g., the coronal suture) in use.

[0228] In certain forms of the present technology, the patient interface 3000 is configured so that the connection port 3600 can be positioned at a series of positions across the crown of the patient's head, allowing the patient interface 3000 to be positioned to suit the comfort or fit of an individual patient. In some examples, the headgear tubes 3350 are 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 chamber 3200). That is, the connection port 3600 may be at least partially decoupled from the plenum chamber 3200. In this manner, the seal-forming structure 3100 may form an effective seal with the patient's face regardless of the position (at least within a predetermined range of positions) of the connection port 3600 on the patient's head.

[0229] As mentioned above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle cushion that is typically positioned under the nose and sealed around the underside of the nose. The positioning and stabilizing structure 3300, including the tube 3350, may be constructed and arranged to draw the seal-forming structure 3100 onto the patient's face under the nose with a sealing force that has a posterior and superior direction (e.g., a posterior-superior direction). The sealing force that has a posterior-superior direction causes the seal-forming structure 3100 to form a good seal around the underside of the patient's nose and with the forward-facing surfaces of the patient's face on either side of the patient's nose and upper lip.

[0230] 5.3.2.1.2 Extendable and non-extendable tube sections In some examples of the present technology, the length of one or two of the tubes 3350 is non-extensible. However, in some forms, the tube 3350 may include one or more extensible tube sections, for example, formed with an extensible bellows-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 with an extensible bellows-like structure. The patient interface 3000 shown in FIG. 4J includes a tube 3350 having an upper portion including extensible tube sections, each tube section being in the form of an extensible bellows-like structure 3362.

[0231] In some forms, the extensible concertina structure 3328 may be formed as a series of ridges and grooves on the surface of the tube 3350. The concertina structure 3328 may be biased toward a retracted position and may move to an extended position when a patient wears the positioning and stabilizing structure 3300. Because portions of the tube 3350 (e.g., the non-extensible tube region 3363) may be substantially non-extensible, the concertina structure 3328 may facilitate the positioning and stabilizing structure 3300 extending to accommodate different head sizes. This may allow a single size tube 3350 to be used for multiple head sizes. For example, the positioning and stabilizing structure 3300 may be "one size fits all" as a result of the concertina structure 3328. 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 concertina structure 3328 may allow minor adjustments to accommodate the individual patient.

[0232] In some forms, the inlet 3332 may be located in the center of the conduit 6320. For example, the tube 3350 may be symmetrical about the inlet 3332 across at least one axis.

[0233] The cross-sectional shape of the non-extensible segment 3363 of the tube 3350 may be circular, oval, elliptical, D-shaped, or rectangular with rounded corners, for example, as described in U.S. Patent No. 6,044,844. Cross-sectional shapes that present a flatter surface of the tube on the side that faces and contacts other parts of the patient's face or head may be proportionately more comfortable to wear as tubes having circular cross-sections.

[0234] In some examples of the present technology, the non-extensible tube segment 3363 is connected to the plenum chamber 3200 at a low angle. The headgear tube 3350 may extend downward along either side of the patient's head, then curve forward and in the middle to connect to the plenum chamber 3200 in front of the patient's face. The tube 3350 may extend to the same vertical position as (or, in some examples, lower than) the connection to the plenum chamber 3200 before connecting to the plenum chamber 3200. That is, the tube 3350 may protrude at least partially in an elevated direction before connecting to the plenum chamber 3200. A portion of the tube 3350 may be located below the plenum chamber 3200 and / or the seal-forming structure 3100. The tube 3350 may contact the patient's face below the patient's cheekbones, which may be more comfortable than contacting above the patient's cheekbones and may avoid excessive blurring of the patient's peripheral vision.

[0235] 5.3.2.1.3 Conduit-type headgear connection ports

[00130] In certain forms of the present technology, the patient interface 3000 may include a connection port 3600 located near the top, side, or back of the patient's head. For example, in the form of the present technology shown in FIG. 4J, the connection port 3600 is located on the top of the patient's head. In this example, the patient interface 3000 includes an elbow 3610 at which the connection port 3600 is provided. The elbow 3610 may be configured to fluidly connect to a conduit of the air circuit 4170. The elbow 3610 may be configured to pivot relative to the positioning and stabilizing structure 3300 to decouple the conduit from the positioning and stabilizing structure 3300. The elbow 3610 may be configured to rotate by rotating about a substantially vertical axis in some examples, and in some specific examples, may be configured to rotate by rotating about two or more axes. In some examples, the elbow may include a tube 3350 or may be connected to the tube 3350 via a ball and socket joint. The connection port 3600 may be located in the sagittal plane of the patient's head during use.

[0236] A patient interface with a connection port that is not positioned in front of the patient's face can be advantageous because some patients find it unsightly and intrusive when the conduit is connected to the patient interface in front of the face. For example, a conduit that connects to a patient interface in front of the face can easily become tangled in bedding or bed linens (especially if the conduit extends downward from the patient interface during use). Forms of the present technology include a patient interface with a connection port that is located above the patient's head during use, allowing the patient to sleep more easily or comfortably in one or more of a side-sleeping position, a supine position (e.g., a supine position, a substantially upward-facing position), or a prone position (e.g., a prone position, a substantially downward-facing position). Furthermore, connecting the conduit to the front of the patient interface can exacerbate a problem known as tube drag, in which the conduit exerts an undesirable force on the patient interface during movement of the patient's head or the conduit, causing it to become dislodged from the face. Tube resistance may not be an issue (where tube resistance is more likely to disrupt the seal) if the force is applied at a higher position on the patient's head than at the front of the patient's face, closer to the seal-forming structures.

[0237] 5.3.2.1.4 Headgear Tube Fluid Connections The two tubes 3350 are fluidly connected at their lower ends to the plenum chamber 3200. In certain forms of the present technology, the connection between the tubes 3350 and the plenum chamber 3200 is achieved by the connection of two rigidizer connectors. The tubes 3350 and the plenum chamber 3200 may be configured to allow the patient to easily connect the two components in a secure manner. The tubes 3350 and the plenum chamber 3200 may be configured to provide tactile and / or auditory feedback in the form of a "reassurance click" or similar sound so that the patient can easily know when each tube 3350 is properly connected to the plenum chamber 3200. In one form, the tubes 3350 are formed of silicone, and the lower end of each silicone tube 3350 is overmolded with a rigid connector, for example, with polypropylene, polycarbonate, nylon, etc. The rigid connector on each tube 3350 may include a male mating feature configured to connect to a female mating feature on the plenum chamber 3200. Alternatively, the rigid connector on each tube 3350 may include a female mating feature configured to connect to a male mating feature on the plenum chamber 3200. In other examples, the tube 3350 may include a male or female connector formed from a flexible material such as silicone or TPE, such as the same material forming the tube 3350.

[0238] 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 may need to be slightly extruded to reduce its diameter so that it can fit into a port in the plenum chamber 3200, and the inherent resilience of the silicone may push the tube 3350 outward, hermetically sealing the tube 3350 to the port. Alternatively, for a hard-to-hard type engagement between the tube 3350 and the plenum chamber 3200, each tube 3350 and / or the plenum chamber 3200 may include a pressure-activated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange may press against the joint between the tube and the inner circumferential surface around the port or connector of the plenum chamber 3200, creating or strengthening a seal between the tube 3350 and the plenum chamber 3200.

[0239] 5.3.2.2 Headgear straps In some forms, the positioning and stabilizing structure 3300 may include headgear 3302 having at least one strap that the patient may wear to assist in properly orienting the seal-forming structure 3100 relative to the patient's face (e.g., to reduce or prevent leakage).

[0240] As mentioned above, some forms of headgear 3302 may be constructed from a woven material that may be comfortable against the patient's skin. The fabric may be flexible to conform to various facial contours. However, the fabric may include stiffness along selected lengths that may limit the folding, bending, and / or extension of the headgear 3302.

[0241] In certain forms, the headgear 3302 may be at least partially stretchable. For example, the headgear 3302 may comprise a stretchable or similar stretchable material. For example, the entire headgear 3302 may be stretchable, or selected portions may be stretchable (or more stretchable than surrounding portions). This may allow the headgear 3302 to stretch while under tension, which may help provide a sealing force to the seal-forming structure 3100.

[0242] Two forms of headgear, four-point headgear 3302-1 and two-point headgear 3302-2, are detailed below as illustrative examples.

[0243] 5.3.2.2.1 Four-point connection 4E, some forms of headgear 3302-1 may be four-point connection headgear, meaning that the headgear 3302-1 may be connected in four separate locations on the plenum chamber 3200, on a frame connected to the plenum chamber 3200, and / or on an arm connected to the plenum chamber 3200. The headgear 3302-1 may include four different straps that provide tension to help maintain the seal-forming structure 3100 in a sealing position.

[0244] In some forms, the headgear 3302-1 may include lower straps 3304-1 that may connect to a lower portion of the cushion 3050-1. The lower straps 3304-1 may extend along the patient's cheeks toward the posterior region of the patient's head. For example, the lower straps 3304-1 may overlap the masseter muscles on either side of the patient's face. Thus, the lower straps 3304-1 may contact the patient's head below the patient's ears. The lower straps 3304-1 may meet at the rear of the patient's head and overlap the occipital bone and / or trapezius muscles.

[0245] The headgear 3302-1 may further include an upper strap 3305-1 that may cover the temporal, parietal, and / or occipital bones. The upper strap 3305-1 may also be connected to a tube 3350 (e.g., by interfacing with tab 3320).

[0246] The rear straps 3307-1 may extend between the upper straps 3305-1 and between the lower straps 3304-1. The lower straps 3304-1 and upper straps 3305-1 on a given side (e.g., left or right) may also be connected to adjacent rear straps 3307-1. The height of the rear straps 3307-1 may therefore be approximately the combined height of the lower straps 3304-1 and the upper straps 3305-1. The rear straps 3307-1 may overlap the occipital and / or parietal bones during use. This may allow the rear straps 3307-1 to assist in securing the headgear 3302-1 to the patient's head.

[0247] In the illustrated example, the headgear 3302-1 may be formed substantially in the shape of an X. The lower and upper straps 3304-1, 3305-1 may be connected to the rear strap 3307-1 using stitching, ultrasonic welding, or any similar process.

[0248] In some forms, the lower straps 3304-1 are connected to the magnetic member 3306-1. For example, each lower strap 3304-1 may be threaded through the magnetic member 3306-1 so that the length of each lower strap 3304-1 may be adjusted. The magnetic member 3306-1 may be detachably connected to the magnet 3370-1 (described below), such that the lower straps 3304-1 may be disconnected from the plenum chamber 3200, but the length of the lower straps 3304-1 may not be affected.

[0249] In some forms, the upper straps 3305-1 may be directly connected to tabs 3320 on the tube 3350. The upper straps 3305-1 may be threaded through the tabs 3320 to adjust the length and control the tension of each upper strap 3305-1.

[0250] In some forms, the headgear 3302-1 may be used with only the nose-mouth cushion 3050-1 (e.g., because the nose-only cushion 3050-1 does not have four connection points), but the headgear 3302-1 may be used interchangeably with the tube 3350 and rigidiser arm 3340.

[0251] 5.3.2.2.2 Two-point connection As shown in Figure 4F, some forms of headgear 3302-2 may be two-point connection headgear, which means that the headgear 3302-2 can be connected in two separate places.

[0252] 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 connected together (e.g., sewn). This may be more comfortable for the patient because they will not come into contact with seams or joints connecting different straps. In other forms, the headgear 3302-2 may be formed from multiple straps (e.g., two top straps, a back strap, etc.) connected together (e.g., by stitching, ultrasonic welding, etc.).

[0253] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headgear strap that acts on more than the tube 3350 to position and stabilize the seal-forming structure 3100 at the entrance to the patient's airway. As shown in FIG. 4F , the patient interface 3000 includes a posterior strap 3307-2 that forms part of the positioning and stabilizing structure 3300. The posterior strap 3307-2 may be known as a back strap or rear head strap, for example. The posterior strap 3307-2 may overlap the temporal bone, parietal bone, and / or occipital bone. In other examples of the present technology, one or more additional straps may be provided. For example, a patient interface 3000 according to examples of the present technology having a nasal-oral cushion may have a second, lower, strap configured to lie against the patient's head adjacent the patient's neck and / or against the posterior surface of the patient's neck.

[0254] As shown in FIG. 4F , some forms of headgear 3302-2 may be at least partially bifurcated. For example, rear straps 3307-2 (e.g., configured to contact the back of the patient's head) of headgear 3302-2 may be wider than the peripheral portion of headgear 3302-2. Middle portions 3308-2 of rear straps 3307-2 may include slits 3309-2. The upper portions of rear straps 3307-2 may thus be movable relative to the lower portions as a result of slits 3309-2. This allows the patient to have greater strap coverage in the rear region of their head, which may help better secure headgear 3302-2 to the patient's head due to the absence of lower straps (e.g., 3304-1).

[0255] In some forms, the headgear 3302-2 may be used with only the nasal cushion 3050-2 (e.g., because the muzzle cushion 3050-1 does not have four connection points), but the headgear 3302-2 may be used interchangeably with the tube 3350 and rigidiser arm 3340.

[0256] 5.3.2.3 Rigidiser Arm 4D, the rigidiser arms 3340 may be elongated rigid members that help maintain the cushions (e.g., nasal-oral cushion 3050-1 or nasal cushion 3050-2) in an operative position. The rigidiser arms 3340 may contact the sides of the patient's head and provide a force that limits slippage of the seal-forming structure 3100 from the patient's nose and / or mouth.

[0257] In some forms, the rigidiser arm 3340 is constructed from a hard material (e.g., plastic), which may not allow the rigidiser arm 3340 to extend.

[0258] In some forms, the rigidiser arm 3340 can be flexible along at least one direction. For example, the rigidiser arm 3340 can be flexible along its width but not along its length. In other words, the rigidiser arm 3340 can bend about an axis along the width of the rigidiser arm 3340, but not about an axis perpendicular to the rigidiser arm 3340. This can allow individual patients to adjust the rigidiser arm 3340 to better fit their individual heads.

[0259] In certain configurations, the rigidiser arms 3340 may remain in the new position after being bent, which may allow the patient to adjust the shape of the rigidiser arms 3340 to their particular head, and then the rigidiser arms 3340 will maintain the desired shape during use to promote patient comfort.

[0260] In some forms, the first end 3342 of the rigidiser arm 3340 may be a free end, and the second end 3344 of the rigidiser arm 3340 (e.g., the opposite end from the first end 3342) may be fixed. The first end 3342 may be curved to minimize sharp edges that may cause discomfort to the patient. Additionally, the first end 3342 may cover the patient's head adjacent the temporal bone during use. The second end 3344 may be fixed to the arm connection structure 3504.

[0261] In some forms, the arm connecting structure 3504 may be similar to the conduit connecting structure 3500. For example, the arm connecting structure 3504 and the conduit connecting structure 3500 may have substantially the same shape. This may allow either the conduit connecting structure 3500 or the arm connecting structure 3504 to fit into a groove (e.g., 3266-1 or 3266-2) and connect to the plenum chamber inlet port 3254. The arm connecting structure 3504 may be connected to the nasal-oral cushion 3050-1 or the nasal cushion 3050-2 via substantially the same method as the conduit connecting structure 3500 (e.g., a snap fit, a press fit, a friction fit, etc.).

[0262] In some forms, the arm connecting structure 3504 may function as a plug for the plenum chamber inlet port 3254 (e.g., either 3254-1 and / or 3254-2). Unlike the tube 3350, the rigidiser arm 3340 does not deliver pressurized air to the plenum chamber 3200. The rigidiser arm 3340 may be used in a "tube down" configuration, where a hose is connected to the ventilation opening 3402 (e.g., either 3402-1 and / or 3402-2) and delivers air through the ventilation opening 3402 to the plenum chamber 3200. In this example, air does not need to be passed to or from the plenum chamber inlet port 3254. Thus, the arm connecting structure 3504 may form a seal with the plenum chamber inlet port 3254 to restrict air flow into or out of the plenum chamber 3200.

[0263] 5.3.3 Ventilation vents In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow the expulsion of exhaled gases, for example carbon dioxide.

[0264] In certain forms, the vent 3400 is configured to allow continuous ventilation port flow from the interior of the plenum chamber 3200 to the environment while maintaining a positive pressure within the plenum chamber relative to ambient. The vent 3400 is configured to have a ventilation flow rate large enough to reduce rebreathing of CO2 inhaled by the patient while maintaining a therapeutic pressure within the plenum chamber during use.

[0265] One form of a vent 3400 in accordance with the present technology includes a plurality of holes (eg, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes).

[0266] The vent 3400 may be located on the plenum chamber 3200. Alternatively, the vent 3400 is located in a separate structure, such as a swivel.

[0267] 4N, the ventilation opening 3450 may be used in conjunction with the patient interface 3000. The ventilation opening 3450 may have a substantially similar shape to the ventilation opening 3402-1 (e.g., a substantially circular shape).

[0268] The ventilation opening 3450 may be used in conjunction with either the oral-nasal plenum chamber 3200-1 (eg, shown in FIG. 4A) or the nasal-only plenum chamber 3200-2 (eg, shown in FIG. 4B).

[0269] 4A , the vent 3450 may include a vent housing 3404 that may be configured to engage with the ventilation opening 3402. The vent housing 3404 may be constructed from a rigid or semi-rigid material. For example, the vent housing 3404 may be constructed from plastic, metal, or any similar material. The vent housing 3404 may add rigidity to the patient interface 3000 (e.g., to limit unwanted bending that may affect the position of the seal-forming structure 3100 on the patient's face).

[0270] The vent housing 3404 may include a front surface 3408, a rear surface 3412, and a groove 3416. The front surface 3408 may face away from the patient's face in use and may be located outside the pressurized volume of the plenum chamber 3200. The rear surface 3412 is located opposite the front surface 3408. In use, the rear surface 3412 may face the patient and may be located within the pressurized volume of the plenum chamber 3200. The groove 3416 may be formed between the front surface 3408 and the rear surface 3412. A portion of the plenum chamber 3200 may be received in the groove 3416 to hold the vent 3400 in place.

[0271] In some forms, a diffuser 3448 may be used in conjunction with the vent housing 3404. The diffuser 3448 may help limit the decibel output from either of the patient interfaces 3000 (or any other patient interface). Specifically, the diffuser 3448 may help limit the decibel level associated with air output (e.g., exhaled breath) from the patient interface 3000, but the diffuser 3448 may limit the decibel level at any point on the patient interface.

[0272] In certain forms, the diffuser 3448 may diffuse, and therefore slow, the exhaust gases exiting the plenum chamber 3200 and passing through the vent housing 3404. The diffuser 3448 may help avoid exhaust and associated discomfort to the patient and / or bed partner (e.g., noise caused by exhaust onto pillows, sheets, bedding, etc.).

[0273] In some forms, the diffuser may include a front surface 3456 that faces away from the patient during use. The outer diameter of the front surface 3456 may be smaller than the inner diameter of the vent housing 3404 adjacent the front surface 3408. This may create a gap 3464 through which air can pass.

[0274] 5.3.4 Decoupling structure(s) In one form, the patient interface 3000 includes at least one decoupling structure (eg, a swivel or a bulb).

[0275] 5.3.4 Modularity As noted above, the cushion, headgear, and sleeve may be provided in different formats that may accommodate different uses (e.g., mouth breathing, nose breathing, etc.). A patient or clinician may select a particular combination of cushion, headgear, and sleeve to optimize the effectiveness of treatment and / or comfort for an individual patient. An example of this type of modular design is described in PCT / SG2022 / 050777, filed October 28, 2022, which is incorporated herein by reference in its entirety.

[0276] In some forms, different styles of cushions, headgear, and sleeves may be used interchangeably to form different combinations of patient interfaces. This can be beneficial from a manufacturing standpoint, as a greater variety of patient interfaces may be created using fewer parts. Additionally or alternatively, various combinations may allow the patient to change the style of patient interface without having to change all of the parts.

[0277] Air is delivered to the patient in one of two main ways. In one example, the patient may receive the pressurized air flow through headgear tubes 3350 (see, e.g., FIGS. 4C, 4J). This may be referred to as a "tube-up" configuration, with the connection port located at the top of the patient's head. In another example, the patient may receive the pressurized air flow through a conduit connected to the plenum chamber 3200. This may be referred to as a "tube-down" configuration, with the airflow conduit located in front of the patient's face. Different patients may find one mode of air delivery more comfortable than another (e.g., due to the patient's sleeping style). Therefore, it may be beneficial to be able to use a single mode of patient interface in either the "tube-up" or "tube-down" configuration.

[0278] The patient interface may be part of a modular assembly with various interchangeable components, where the patient and / or clinician may exchange one or more components for different modalities. The following description describes various combinations that can be made by assembling different components together.

[0279] 5.3.5.1 Sleeve In some forms, to allow for modularity, a sleeve may be used in conjunction with the tube 3350 and / or rigidiser arm 3340. The sleeve may at least partially surround the tube 3350 and / or rigidiser arm 3340. As shown in FIGS. 4G-4I, different shaped sleeves may be used, which may correspond to different types of positioning and stabilizing structure 3300. In some forms, the configuration of the sleeve may be customized to fit a particular user's face. For example, the sleeve may be configured in a relatively posterior region of the patient's head.

[0280] In some embodiments, the sleeve may be constructed from a comfortable material. For example, the sleeve may be constructed from a woven material, a foam material, or a combination of both. The comfortable material may contact the patient during use and may feel soft against the patient's skin to improve patient compliance.

[0281] The material may also be flexible to aid in the attachment and detachment of the sleeve from the tube 3350 or rigidiser arm 3340. For example, the material may allow the sleeve to bend to conform to the shape of the tube 3350 or conduit headgear or rigidiser arm 3340, which may vary depending on the shape of an individual patient's head.

[0282] In some forms, the sleeve may also be at least partially elastic (e.g., the material may allow the sleeve to stretch). The elastic material may help the sleeve stretch to fit around the tube 3350 or rigidiser arm 3340. The elastic material may then return to its initial position snug against the tube 3350 or rigidiser arm 3340 to prevent the sleeve from slipping during use.

[0283] As described in more detail below, some configurations of the sleeve may be inherent to the rigidizer element (e.g., the tube 3350 and / or the rigidizer arm 3340), however, the sleeve may aid in the rigidizer element interchangably connecting with cushion versions or styles (e.g., oral-nasal cushion 3050-1, nasal-only cushion 3050-2, etc.).

[0284] 5.3.5.2 Conduit sleeve As shown in FIG. 4G, one example of a sleeve is a conduit sleeve 3351 that may be used in conjunction with the tubing 3350 described above.

[0285] As shown in Figure 4G, the conduit sleeve 3351 may include a curved shape that may be similar to the shape of the tube 3350 shown in Figure 4C. The flexible material used to construct the conduit sleeve 3351 may allow the conduit sleeve 3351 to further curve to accommodate the shape of the tube 3350 (e.g., when worn by a patient).

[0286] In some forms, the conduit sleeve 3351 may include a first or upper opening 3352. The upper opening 3352 may be located at one end of the conduit sleeve 3351. The upper opening 3352 may be an opening to a passageway that extends along at least a portion of the conduit sleeve 3351.

[0287] As shown in FIG. 4G, some forms of the conduit sleeve 3351 may also include a lower extension 3354. The lower extension 3354 may be located at the end of the conduit sleeve 3351 opposite the upper opening 3352. The conduit sleeve 3351 may be customized to fit the face of a particular user. For example, the lower extension 3354 of the conduit sleeve 3351 may be configured in a relatively posterior or anterior region of the patient's head.

[0288] Some forms of the lower extension 3354 may include a rigid or semi-rigid piece (e.g., within the conduit sleeve 3351). The rigid or semi-rigid piece may be constructed from a plastic or similar material. Alternatively, the lower extension 3354 may be stiffened using a manufacturing process (e.g., stiff thread stitching, flat knitting, use of thicker material).

[0289] 4G, some forms of the lower extension 3354 may include a connecting member 3356. In the example shown, the connecting member 3356 may be a magnet, although in other examples, the connecting member 3356 may be a different type of connector (e.g., mechanical fasteners, adhesive, hook and loop material, etc.). The connecting member 3356 may also be located at the end of the lower extension 3354, although the connecting member 3356 may alternatively be located anywhere along the lower extension 3354.

[0290] In some forms, connecting member 3356 (e.g., a magnet) may be removably connected to magnet 3370-1 of headgear 3302-1. For example, magnet 3370-1 connected to lower strap 3304-1 may be removably connected to connecting member 3356 to provide a pulling force when conduit sleeve 3351 is connected to tubing 3350 (see, e.g., FIG. 4J).

[0291] 5.3.5.2.1 Four-point arm sleeve As shown in FIG. 4H, another example of a sleeve is a four-point arm sleeve 3380 that may be used in conjunction with the rigidiser arm 3340 described above.

[0292] As shown in Figure 4H, the four point arm sleeve 3380 may include a curved shape that may be similar to the shape of the rigidiser arm 3340 shown in Figure 4D. The flexible material used to construct the four point arm sleeve 3380 may allow the four point arm sleeve 3380 to further curve to accommodate the shape of the rigidiser arm 3340 (e.g., when worn by the patient and / or bent by the patient).

[0293] As shown in FIG. 4H, some forms of four-point arm sleeve 3380 may include a lower extension 3384. The lower extension 3384 may be located at the end of the four-point arm sleeve 3380.

[0294] In the example shown, the shape and / or configuration of the lower extension 3384 is substantially the same as the shape of the lower extension 3354. For example, the lower extension 3384 may be more rigid (e.g., as a result of rigidizer threads or a stiff material) compared to the remainder of the four-point arm sleeve 3380.

[0295] 4H , some forms of the lower extension 3384 may include a connecting member 3386. In the example shown, the connecting member 3386 may be a magnet, but in other examples, the connecting member 3386 may be a different type of connector (e.g., mechanical fasteners, adhesive, hook and loop material, etc.). The connecting member 3386 may also be located at the end of the lower extension 3384, but the connecting member 3386 may alternatively be located anywhere along the lower extension 3384.

[0296] In some forms, the connecting member 3386 (e.g., a magnet) may be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when a four-point arm sleeve 3380 is connected to the rigidiser arm 3340 (see, e.g., FIG. 4K), the magnet 3370-1 connected to the lower strap 3304-1 may be removably connected to the connecting member 3386 to provide the pulling force.

[0297] 4H, the four-point arm sleeve 3380 may include a pair of tabs 3394 that may be similar to the tabs 3320 on the tube 3350. When the four-point arm sleeve 3380 is worn by the patient, the tabs 3394 may be positioned on the patient's head in substantially the same location as the tabs 3320 are positioned when the patient wears the tube 3350.

[0298] 5.3.5.2.2 Two-point arm sleeve As shown in FIG. 4I, yet another example of a sleeve is a two-point arm sleeve 3380-1 that may be used in conjunction with the rigidiser arm 3340 described above.

[0299] 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 will be described below.

[0300] 41, the two-point arm sleeve 3380-1 may include a lower opening 3388-1 disposed at an end of the two-point arm sleeve 3380-1. The lower opening 3388-1 may form an opening to a passageway through the two-point arm sleeve 3380-1. In the example shown, the lower opening 3388-1 may open to a surface of the conduit sleeve 3380-1.

[0301] 41, the two-point arm sleeve 3380-1 may include a pair of tabs 3394-1 similar to the tabs 3320 on the tube 3350. When the two-point arm sleeve 3380-1 is worn by the patient, the tabs 3394-1 may be positioned in substantially the same location on the patient's head as the tabs 3320 are positioned when the patient wears the tube 3350.

[0302] 5.3.5.3 Assembled Patient Interface As shown in Figures 4J-4M, the various elements described above may be combined into four different patient interfaces. The different patient interfaces may allow patients to use different modalities based on their individual comfort. The modularity of the different elements (e.g., the ability to be used in multiple modalities of patient interfaces) may simplify manufacturing and / or allow patients to more easily switch between modalities of patient interfaces.

[0303] 5.3.5.3.1 Oral-nasal mask tube-up configuration 4J, the patient may wear the cushion 3050-1 in a tube-up configuration with the tube 3350 and four-point headgear 3302-1. This assembly may form the tube-up nose-mouth patient interface 3000-1.

[0304] In some forms, a conduit sleeve may be used in conjunction with the tubing 3350 to allow the patient to experience a "tube up" air delivery style with the oral-nasal cushion 3050-1. As described below, the conduit sleeve provides an additional connection location for connecting the four-point headgear 3302-1. However, other forms of connectors may be used separately or in addition to the conduit sleeve.

[0305] In the example shown, the conduit sleeve may be connected to tubing 3350 of the positioning and stabilizing structure 3300. The tubing 3350 (via the conduit connection structure 3500) may be used to connect the tubing 3350 to the cushion 3050-1. The conduit sleeve provides a magnet for connecting to the magnet 3370-1 (see, e.g., FIG. 4E) of the four-point headgear 3302-1. Alternatively, another connection may be used.

[0306] As shown in FIG. 4J, the four-point headgear 3302-1 may connect at four separate locations to provide tension that keeps the cushion 3050-1 in a sealing position on the patient's head.

[0307] For example, the lower straps 3304-1 may be removably connected (e.g., via the magnetic members 3306-1) to the magnets of the conduit sleeve. In use, each lower strap 3304-1 may contact the patient's cheek (e.g., overlying the masseter muscles). The lower straps 3304-1 may also extend below the patient's ears.

[0308] 5.3.5.3.2 Oronasal mask tube-down configuration 4K, the patient may wear the cushion 3050-1 in a tube-down configuration with the rigidiser arms 3340 and four-point headgear 3302-1. This assembly may form a tube-down nose-to-mouth patient interface 3000-2.

[0309] In some forms, a conduit sleeve may be used in conjunction with the rigidiser arm 3340 to allow the patient to experience a "tube down" air delivery style with the oral-nasal cushion 3050-1. As described below, the conduit sleeve provides an additional connection location for connecting the four-point headgear 3302-1. However, other forms of connectors may be used separately or in addition to the conduit sleeve.

[0310] In the example shown, the conduit sleeve may be connected to the rigidiser arm 3340 of the positioning and stabilising structure 3300. The rigidiser arm 3340 (via the conduit connection structure 3504) may be used to connect the rigidiser arm 3340 to the cushion 3050-1. The conduit sleeve provides a magnet to connect to the magnet 3370-1 (see, e.g., FIG. 4E) of the four-point headgear 3302-1. Alternatively, another connection configuration may be used.

[0311] As shown in FIG. 4K, the four-point headgear 3302-1 may connect at four separate locations to provide tension that keeps the cushion 3050-1 in a sealed position on the patient's head.

[0312] For example, the lower straps 3304-1 may be removably connected (e.g., via the magnetic members 3306-1) to the magnets of the conduit sleeve. In use, each lower strap 3304-1 may contact the patient's cheek (e.g., overlying the masseter muscles). The lower straps 3304-1 may also extend below the patient's ears.

[0313] 5.3.5.3.3 Nasal mask tube-up configuration 4L, the patient may wear the cushion 3050-2 in a tube-up configuration with the tube 3350 and two-point headgear 3302-2. This assembly may form a tube-up nasal-only patient interface 3000-3.

[0314] A conduit sleeve may be used in conjunction with the tube 3350 to provide additional comfort to the patient. The sleeve may not add an additional connection point for connecting the positioning and stabilizing structure 3300 on the cushion 3050-2. In the example shown, the tube 3350 of the positioning and stabilizing structure 3300 may be connected directly to the cushion 3050-2.

[0315] As shown in FIG. 4L, two-point headgear 3302-2 may be connected to tabs 3320 on tubes 3350 to provide a tensioning force that maintains cushion 3050-2 in a sealing position on the patient's head.

[0316] 5.3.5.3.4 Nasal mask tube down configuration 4M, the patient may wear the cushion 3050-2 in a tube-up configuration with the rigidiser arms 3340 and two-point headgear 3302-2. This assembly may form a tube-down nose-only patient interface 3000-4.

[0317] The conduit sleeve may be used in conjunction with the rigidiser arm 3340 to provide additional comfort to the patient. The sleeve may not add an additional connection point for connecting the positioning and stabilizing structure 3300 on the cushion 3050-2. In the example shown, the rigidiser arm 3340 of the positioning and stabilizing structure 3300 may be connected directly to the cushion 3050-2.

[0318] As shown in FIG. 4M, two-point headgear 3302-2 may be connected to tabs 3320 on the sleeve to provide tension that keeps the cushion 3050-2 in a sealed position on the patient's head.

[0319] 5.3.5.3.5 Element modularity Figure 4P shows how different elements can be combined to form the four different patient interfaces described above. As shown, different components can be reused for different styles of patient interfaces. This potentially allows for easier manufacturing and assembly, as many of the same components can be manufactured and used in a variety of styles. The only part that is not used in multiple styles is the sleeve. However, the sleeve may be easier to manufacture. Figure 4O shows a portion of an air circuit 4170 that can interface with a patient interface, while Figure 4N shows a vent housing 3404 that can interchangeably replace the air circuit shown in Figure 4O depending on the style of patient interface.

[0320] 5.4 RPT Device 3A-3C, an RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300, such as all or part of the methods described herein. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, such as for the treatment of one or more respiratory disorders described elsewhere herein.

[0321] 5.4.1 Air filter(s) An RPT device in accordance with one form of the present technology may include an air filter 4110 or multiple air filters 4110.

[0322] In one form, shown in FIG. 3A, the inlet air filter 4112 is located at the beginning of the air pressure path upstream of the pressure generator 4140 .

[0323] In one form shown in FIG. 3A, an outlet air filter 4114, for example an antibacterial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.

[0324] 5.4.2 Muffler(s) An RPT device in accordance with one form of the present technology may include a muffler 4120 or multiple mufflers 4120.

[0325] In one form of the present technology (see, for example, FIG. 3A), an inlet muffler 4122 is located in the air pressure path upstream of a pressure generator 4140 .

[0326] In one form of the present technology, the outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800.

[0327] 5.4.3 Pressure generator In one form of the present technology, the pressure generator 4140 for generating a flow or source of positive pressure air is a controllable blower 4142 .

[0328] The pressure generator 4140 may be controlled by a therapy device controller 4240 .

[0329] In other forms, pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (eg, a pressurized air reservoir), or a bellows.

[0330] 5.4.4 Transducer(s) The transducer may be internal to the RPT device or external to the RPT device. An external transducer may be located on or form part of the air circuit (e.g., patient interface), for example. The 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.

[0331] In one form of the present technology (see, e.g., FIG. 3A), one or more sensors 4270 are positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate a signal representative of a characteristic of the air flow, such as flow rate, pressure, or temperature at that point in the pneumatic path.

[0332] In one form of the present technology, one or more transducers 4270 may be located proximate to the patient interface 3000 or 3800.

[0333] In one form, the signal from the converter 4270 may be filtered, such as by low-pass filtering, high-pass filtering, or band-pass filtering.

[0334] 5.4.5 RPT Sensor 5.4.5.1 Flow Sensor A flow sensor 4274 according to the present technology may be based on a differential pressure transducer, for example, SENSIRION's SDP600 series differential pressure transducer.

[0335] In one form, a signal generated by the flow sensor 4274 and representative of the flow rate is received by the central controller 4230.

[0336] 5.4.5.2 Pressure Sensors A pressure sensor 4272 according to the present technology is positioned in fluid communication with the pneumatic path. Examples of suitable pressure sensors include transducers from the HONEYWELL ASDX series. An alternative suitable pressure sensor is a transducer from the GENERAL ELECTRIC NPA series.

[0337] In one form, a signal generated by the pressure sensor 4272 and representative of the pressure is received by the central controller 4230.

[0338] 5.4.6 Motor Speed ​​Transducers In one form of the present technology, a motor speed sensor 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 sensor 4276 may be, for example, a speed sensor such as a Hall effect sensor.

[0339] 5.4.7 Check valve 3A, in one form of the present technology, the anti-reflux valve 4160 may be located between the humidifier 5000 and the pneumatic block 4020. The anti-reflux valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000, for example towards the motor 4144.

[0340] 5.4.8 Electrical Components of RPT Devices 5.4.8.1 Power supply The power supply 4210 may be located inside or outside the external housing 4010 of the RPT device 4000.

[0341] In one form of the present technology, the power supply 4210 powers only 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.

[0342] 5.4.8.2 Input Devices 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 turntables that allow a person to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessible via a touchscreen. The buttons, switches, or dials may be physically connected to the external housing 4010 in one form, or may communicate wirelessly with a receiver electrically connected to the central controller 4230 in another form.

[0343] In one form, the input device 4220 may be constructed and arranged to allow a person to select values ​​and / or menu options.

[0344] 5.4.8.3 Central Controller In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000. The central controller 4230 is shown in Figure 3B.

[0345] Suitable processors may include x86 INTEL processors, processors based on ARM® Cortex®-M processors from ARM Holdings (e.g., the STM32 series of microphone controllers from ST MICROELECTRONIC). In certain alternative forms of the present technology, 32-bit RISC CPUs such as the ST MICROELECTRONICS STR9 series of microphone controllers manufactured by TEXAS INSTRUMENTS, or 16-bit RISC CPUs such as processors from the MSP430 family of microphone controllers may also be suitable.

[0346] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0347] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0348] The central controller 4230 may be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220, and / or the humidifier 5000.

[0349] The central controller 4230 may be configured to provide output signal(s) to one or more of the output device 4290, the pressure generator 4140, the therapy device controller 4240, the data communication interface 4280, and / or the humidifier 5000.

[0350] In some forms of the present technology, the central controller 4230 is configured to implement one or more methodologies described herein, e.g., one or more algorithms 4300, which may be implemented by processor control instructions expressed as a computer program stored in a non-transitory computer-readable storage medium (e.g., 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 methodologies may be performed by a remotely located device. For example, the remote device may analyze stored data, such as data from any of the sensors described herein, to determine ventilator control settings or detect respiratory-related events.

[0351] 5.4.8.4 Clock The RPT device 4000 may include a clock 4232 connected to the central controller 4230 .

[0352] 5.4.8.5 Therapy Device Controller In one form of the present technology, the therapy device controller 4240 is a therapy control module 4330 that forms part of the algorithm 4300 executed by the central controller 4230.

[0353] In one form of the present technology, the therapy 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.

[0354] 5.4.8.6 Protection circuit The one or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0355] 5.4.8.7 Memory In accordance with one form of the present technology, the RPT device 4000 includes memory 4260, such as non-volatile memory. In some forms, the memory 4260 may include battery-powered static RAM. In some forms, the memory 4260 may include volatile RAM.

[0356] Memory 4260 may be located on PCBA 4202. Memory 4260 may take the form of EEPROM or NAND flash.

[0357] Additionally or alternatively, the RPT device 4000 includes a form of removable memory 4260, such as a memory card manufactured in accordance with the Secure Digital (SD) standard.

[0358] In one form of the present technology, the memory 4260 functions as a non-transitory computer-readable storage medium on which are stored computer program instructions embodying one or more methodologies, e.g., one or more algorithms 4300, described herein.

[0359] 5.4.8.8 Data communication systems In one form of the present technology, a data communications interface 4280 is provided and connected to a central controller 4230 (see, for example, FIG. 3B ). The data communications interface 4280 may be connectable to a remote external communications network 4282 and / or a local external communications network 4284. The remote external communications network 4282 may be connectable to a remote external device 4286. The local external communications network 4284 may be connectable to a local external device 4288.

[0360] In one form, the data communication interface 4280 is part of the central controller 4230. In another form, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.

[0361] In one form, the remote external communications network 4282 is the Internet. The data communications interface 4280 may be connected to the Internet using wired communications (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE).

[0362] In one form, the local external communications network 4284 uses one or more communications standards (eg, Bluetooth or consumer infrared protocols).

[0363] In one form, the remote external device 4286 is one or more computers, for example, a cluster of networked computers. In one form, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be available to appropriately authorized personnel, such as a clinician.

[0364] The local external device 4288 may be a personal computer, a cell phone, a tablet, or a remote control.

[0365] 5.4.8.9 Output devices, including optical displays, alerts An output device 4290 according to the present technology may take the form of one or more of a visual, auditory and tactile unit. The visual display may be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0366] 5.4.8.9.1 Display Drivers The display driver 4292 receives as input characters, symbols or images intended to be displayed on the display 4294 and converts them into commands that cause the display 4294 to display them.

[0367] 5.4.8.9.2 Display Display 4294 is configured to visually display characters, symbols, or images in response to commands received from display driver 4292. For example, display 4294 may be an eight-segment display, in which case display driver 4292 converts each character or symbol (e.g., the digit "0") into eight logic signals indicating which of the eight segments should be activated to display the particular character or symbol.

[0368] 3A-3C, in some forms of the present technology, a central controller 4230 may be configured to implement one or more algorithms 4300 expressed as computer programs stored in a non-transitory computer-readable storage medium, such as a memory 4260. The algorithms 4300 are generally categorized into groups called modules.

[0369] In other forms of the present technology, part or all of the algorithm 4300 may be implemented by a controller of an external device (e.g., a local external device 4288 or a remote external device 4286). In this form, input signal and / or intermediate algorithm output data required to implement the portion of the algorithm 4300 executed on the external device may be transmitted to the external device via a local external communications network 4284 or a remote external communications network 4282. In such form, the portion of the algorithm 4300 executed on the external device may be expressed as a computer program stored on a non-transitory computer-readable storage medium accessible to the controller of the external device, with processor control instructions, etc., executed by one or more processor(s). Such a program configures the controller of the external device to execute the portion of the algorithm 4300.

[0370] In such a configuration, therapy parameters generated by the external device via the therapy engine module 4320 (if such a configuration forms part of the algorithm 4300 executed by the external device) may be communicated to the central controller 4230 and sent to the therapy control module 4330.

[0371] 5.4.8.10 Pre-processing module 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 process steps to calculate one or more output values ​​that are used as input to another module, e.g., a therapy engine module 4320.

[0372] In one form of the present technology, the output values ​​include interface pressure Pm, ventilation flow Qv, respiratory flow Qr, and leak flow Ql.

[0373] In various forms of the present technology, the pre-processing module 4310 includes one or more of 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 .

[0374] 5.4.8.10.1 Interface Pressure Estimation In one form of the present technology, an interface pressure estimation algorithm 4312 receives as inputs a signal from a pressure sensor 4272 indicating the pressure in the pneumatic path near the pneumatic block outlet (device pressure Pd) and a signal from a flow sensor 4274 representing the rate of airflow exiting the RPT device 4000 (device flow Qd). The device flow Qd may be used as the total flow Qt in the absence of supplemental gas 4180. 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 may be modeled for a particular air circuit 4170 by a pressure drop characteristic ΔP(Q). The interface pressure estimation algorithm 4312 then provides an estimated pressure, Pm, as an output to the patient interface 3000 or 3800. The pressure Pm in the patient interface 3000 or 3800 is estimated to be the device pressure Pd minus the air circuit pressure drop ΔP.

[0375] 5.4.8.10.2 Vent flow rate estimation In one form of the present technology, an airflow estimation algorithm 4314 receives as input the estimated pressure Pm at the patient interface 3000 or 3800 from the interface pressure estimation algorithm 4312 and estimates the airflow of air Qv through the vent 3400 at the patient interface 3000 or 3800. For the particular vent 3400 in use, the dependence of airflow Qv on the interface pressure Pm may be modeled by an airflow characteristic Qv(Pm).

[0376] 5.4.8.10.3 Leakage flow rate estimation In one form of the present technology, a leak flow estimation algorithm 4316 receives as inputs the total flow Qt and the ventilation flow Qv and provides as an output an estimate of the leak flow Ql. In one form, the leak flow estimation algorithm estimates the leak flow Ql by calculating the average of the difference between the total flow Qt and the ventilation flow Qv over a period of time long enough to include several respiratory cycles, for example, about 10 seconds.

[0377] In one form, the leak flow estimation algorithm 4316 receives as inputs the total flow Qt, ventilation flow Qv, and estimated pressure Pm at the patient interface 3000 or 3800, provides as output the leak flow Ql, and calculates the leak conductance to determine the leak flow Ql as a function of the leak conductance and the pressure, Pm. The leak conductance is calculated as the quotient of a low-pass filtered unventilated flow equal to the difference between the total flow Qt and the ventilation flow Qv, and the low-pass filtered square root of the pressure Pm, where the low-pass filter time constant has a value long enough to include several respiratory cycles, for example, about 10 seconds. The leak flow Ql may be estimated as a function of the product of the leak conductance and the pressure Pm.

[0378] 5.4.8.10.4 Respiratory flow estimation In one form of the present technology, the respiratory flow estimation algorithm 4318 takes as inputs the total flow QT, the ventilation flow Qv, and the leak flow Ql, and estimates the air respiratory flow Qr for the patient by subtracting the ventilation flow Qv and the leak flow Ql from the total flow Qt.

[0379] 5.4.8.11 Treatment Engine Module In one form of the present technology, the therapy engine module 4320 receives as input one or more of the pressure Pm within the patient interface 3000 or 3800 and the air respiratory flow Qr to the patient, and provides one or more therapy parameters as output.

[0380] In one form of the present technology, the treatment parameter is a treatment pressure, Pt.

[0381] In one form of the present technology, the therapy parameters are one or more of: amplitude of pressure fluctuations, base pressure, and target ventilation.

[0382] In various embodiments, the therapy engine module 4320 includes one or more of a phase determination algorithm 4321, a waveform determination algorithm 4322, a ventilation determination algorithm 4323, an inspiratory flow limitation determination algorithm 4324, an apnea / hypopnea determination algorithm 4325, a snoring determination algorithm 4326, an airway patency determination algorithm 4327, a target ventilation determination algorithm 4328, and a therapy parameter determination algorithm 4329.

[0383] 5.4.8.11.1 Phase determination In one form of the present technology, the RPT device 4000 does not determine the phase.

[0384] In one form of the present technology, the phase determination algorithm 4321 receives as an input a signal indicative of respiratory flow Qr and provides as an output the phase Φ of the patient's 1000 current respiratory cycle.

[0385] 5.4.8.11.2 Waveform determination In one form of the present technology, the therapy parameter determination algorithm 4329 provides a nearly constant therapy pressure throughout the patient's respiratory cycle.

[0386] In another form 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).

[0387] In one form of the present technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ) having values ​​in the range [0, 1] over the domain of the phase values ​​Φ provided by the phase determination algorithm 4321 for use by the therapy parameter determination algorithm 4329.

[0388] 5.4.8.11.3 Ventilation determination In one form of the present technology, a ventilation determination algorithm 4323 takes as input the respiratory flow Qr and determines a measure Vent that is indicative of the current patient ventilation.

[0389] 5.4.8.11.4 Inspiratory Flow Limit Determination In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 to determine the degree of inspiratory flow limitation.

[0390] 5.4.8.11.5 Apnea and Hypopnea Determination In one form of the present technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 to determine the presence of apnea and / or hypopnea.

[0391] 5.4.8.11.6 Snoring determination In one form of the present technology, the central controller 4230 executes one or more snore determination algorithms 4326 to determine the degree of snoring.

[0392] 5.4.8.11.7 Airway Patency Determination In one form of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 to determine the degree of airway patency.

[0393] 5.4.8.11.8 Target ventilation determination In one form of the present technology, the central controller 4230 executes one or more target ventilation determination algorithms 4328 which take as input the current ventilation measurement, Vent, and determine a target value for the ventilation measurement, Vtgt.

[0394] 5.4.8.11.9 Determining Treatment Parameters In some forms of the present technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 to determine one or more treatment parameters using values ​​returned by one or more other algorithms in the treatment engine module 4320.

[0395] 5.4.8.12 Treatment Control Module A therapy control module 4330 in accordance with one aspect of the present technology receives as input therapy parameters from a therapy parameter determination algorithm 4329 of the therapy engine module 4320 and controls the pressure generator 4140 to deliver airflow in accordance with the therapy parameters.

[0396] 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 airflow such that the interface pressure Pm at the patient interface 3000 or 3800 is equal to the therapy pressure Pt.

[0397] 5.4.8.13 Detecting Fault Conditions 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: Power off (power off or insufficient power off) Sensor Fault Detection Inability to detect the presence of a component Operating parameters (pressure, flow, temperature, PaO2, etc.) outside the recommended range The test alarm may include at least one of: a failure to generate a detectable alarm signal.

[0398] When a fault condition is detected, the corresponding algorithm: Initiating audio, visual, and / or dynamic (e.g., vibration) alarms; Sending messages to external devices, Event logging, The system notifies the user of the presence of a fault by one or more of the following:

[0399] 5.5 Patient Interface Detection 5A is a schematic diagram illustrating a respiratory therapy system 8000. The respiratory therapy system 8000 can be configured to wirelessly detect information regarding the patient interface 3000 or accessories a patient is using during a therapy session. In some embodiments, by incorporating technology described further below, a patient interface (or accessory) detection system can be created that does not require the patient to manually scan or input the type of patient interface being used (e.g., via an external device such as a smartphone, computer, tablet, etc., or via a mechanism within the respiratory therapy system). In other embodiments, incorporating a wireless patient interface detection system can enable the respiratory therapy system 8000 to verify the accuracy of the patient's input regarding the type of patient interface (or accessory) being used, or to track the use or other characteristics of the patient interface (or accessory) being used, as described further below.

[0400] The respiratory therapy system 8000 includes a patient interface 3000 and a respiratory pressure therapy (RPT) device 4000 fluidly coupled by an air circuit 4170, which may be a conduit or tube, as described above. As further described above, the RPT device 4000 is configured to supply a flow of gas, e.g., air that may be supplemented with oxygen, to the patient interface 3000 via the air circuit 4170. The RPT device 4000 may include any of the elements described above, such as a humidifier, an oxygen source, and / or a data management system.

[0401] The RPT device 4000 may be used individually or as part of a system 8000 to provide one or more of the therapies described above to a patient's airway, for example, by actuating the device to generate a flow of air for delivery to an interface (e.g., patient interface 3000). The air flow may be pressure-controlled (in the case of respiratory pressure therapy) or flow-controlled (in the case of flow therapy such as HFT). Thus, the RPT device 4000 may also function as a fluid therapy device. The RPT device 4000 may include, for example, a CPAP device and / or a ventilator.

[0402] Respiratory therapy system 8000 may further include a radio frequency identification (RFID) system 9000. RFID system 9000 may be configured to detect, for example, one or more characteristics of the respiratory therapy delivered from RPT device 4000 to patient interface 3000, the identity of patient interface 3000, and / or the identity of an accessory (not shown) directly or indirectly coupled to respiratory therapy system 8000. Exemplary accessory devices include, but are not limited to, for example, patient interface headgear, a cushion on patient interface 3000, an air filter, a humidifier, one or more components of a humidification system (e.g., components of a heat and moisture exchanger or a waterless humidifier), conduits, and / or adapter accessories.

[0403] 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, for example, to uniquely identify and / or track objects. RFID system 9000 may operate according to the principle of inductive coupling.

[0404] The RFID system 9000 includes a transponder 9200 (hereinafter referred to as a "tag"), a transceiver 9300, and an antenna 9100. In some embodiments, the RFID system 9000 includes one antenna 9100. In alternative embodiments described in more detail herein, the RFID system 9000 includes two or more antennas 9100. The antenna 9100 is configured to emit radio waves and receive reflected signals, for example, from the tag 9200. The antenna 9100 may be a linear antenna and therefore may emit linearly polarized signals, or the antenna 9100 may be a circular antenna and therefore may emit circularly polarized signals. In some embodiments, the RFID system 9000 may include both linear antenna(s) and circular antenna(s).

[0405] 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, for example, within a cover 4172 on the proximal portion 4170A of the air circuit 4170, as shown in FIGS. 6A and 6B and described in further detail below. In an alternative embodiment, the antenna 9100 may be disposed within the lumen 4178 of the air circuit 4170 (see FIGS. 6A and 6B). In a further alternative configuration, the antenna 9100 may be fixedly or removably coupled to the exterior of the air circuit 4170, such as, for example, on an outer surface of the air circuit 4170.

[0406] The tag 9200 is configured to emit radio waves to transmit information. The tag 9200 may include a microchip that stores and processes information, such as a unique identifier for the tag 9200 and the antenna 9100, allowing 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 transmit data, which may result in a shorter transmission range. For example, the tag 9200 may receive all of the energy it needs from the magnetic field in which it operates.

[0407] The tag 9200 may be read-only, read / write, or write once and read multiple times. The tag 9200 may be configured to include identification data for the patient interface 3000 and / or the patient. In some embodiments, the tag 9200 may include information related to a date of use or a timestamp. The tag 9200 may additionally or alternatively include information related to the type of patient interface 3000 being used, characteristics of the patient interface 3000 (e.g., one or more of the following: cushion material, cushion size, conduit size, size of the patient interface, length of use of the patient interface, date of manufacture of the patient interface, set of respiratory therapy conditions for which the patient interface is suitable for use, etc.), a serial identification number for the patient interface 3000, a manufacturing batch identification number for the patient interface 3000, and / or other aspects of the respiratory therapy system 8000. In some embodiments, the tag 9200 may be configured to include patient information, such as the type of therapy or therapy setting the patient is intended to receive, or other information. The tag 9200 may also be used to detect connection and / or disconnection of the air circuit 4170 and / or accessories (not shown).

[0408] In some embodiments, the tag 9200 may include an adhesive, for example, to aid in affixing the tag 9200 to the patient interface 3000 and / or maintaining the tag 9200 in place on the patient interface 3000 after affixing. The tag 9200 may alternatively be overmolded into a portion of the patient interface 3000. For example, the tag 9200 may be overmolded into a soft plastic material, such as a silicone cushion, or a hard plastic material, such as the plastic frame of the patient interface 3000. Alternatively, the tag 9200 may comprise conductive silicone and / or conductive thread(s) or ink(s) (e.g., silver ink) printed on the soft and / or hard plastic materials comprising the patient interface 3000. The tag 9200 may comprise, 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.

[0409] 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 at a frequency between about 10 MHz and about 12 GHz (e.g., about 13.56 megahertz (MHz)), and the antenna 9100 may be configured to read data transmitted from the tag 9200 at about 10 MHz and about 12 GHz (e.g., about 13.56 MHz). In other embodiments, the RFID system 9000 may instead be configured to generate an electromagnetic field having a frequency between about 30 kilohertz (kHz) and about 3 gigahertz (GHz). In some examples, the RFID system 9000 may be configured to operate in the low frequency range, or between about 30 kHz and about 300 kHz. Thus, the RFID system 9000 may be configured to have a read range of up to about 10 cm (about 3.94 inches), although the exact distance may vary depending, for example, on the angles of the various components in the system relative to one another. Alternatively, the RFID system 9000 may be configured to operate in the high frequency range, or between approximately 3 MHz and 30 MHz. In such a configuration, the RFID system 9000 may be configured to have a read range of between approximately 10 cm and up to approximately 1 m (approximately 3.94 inches and approximately 39.37 inches). Still further, the RFID system 9000 may be configured to operate in the ultra-high frequency range, or between approximately 300 MHz and 3 GHz. In such a configuration, the RFID system 9000 may be configured to have a read range of between approximately 1 m and up to approximately 12 m. For example, the tag 9200 may be an ultra-high frequency (UHF) tag, a Bluetooth tag, or an ultra-wideband (UWB) tag. The tag 9200 and the antenna 9100 may be tuned to operate at the same frequency. UWB tags 9200 may operate in the frequency band from about 3.1 GHz to about 10.6 GHz, Bluetooth tags 9200 may operate at frequencies of about 2.4 GHz, and UHF tags 9200 may operate at frequencies from about 300 MHz to about 3 GHz.

[0410] In some instances, a shorter read range for the RFID system 9000 may be desirable. For example, if a patient is in close proximity to multiple devices or objects containing RFID components, the RFID system 9000 may accidentally read the tags or antennas of peripheral devices. Therefore, if the RFID system 9000 is configured to operate in a lower frequency band, e.g., 13.56 MHz, the likelihood of the RFID system 9000 accidentally reading a peripheral device is reduced.

[0411] The RFID system 9000 may include a single tag 9200 fixedly or removably coupled to the patient interface 3000 or an accessory (not shown). Alternatively, the RFID system 9000 may include two or more tags 9200 fixedly coupled to the patient interface 3000 or an accessory (not shown). The RFID tags 9200 described herein may be off-the-shelf items or may be customized depending on the size and / or shape of the patient interface 3000 and / or depending on the desired read range of the tag 9200. While the tag 9200 is described herein as being associated with the patient interface 3000, the tag 9200 may alternatively or additionally be associated with, for example, the air circuit 4170 or another accessory of the respiratory therapy system 8000. To the extent the tag 9200 is associated with the air circuit 4170 or another accessory, the tag 9200 may include information regarding the accessory or air circuit with which it is associated.

[0412] The antenna 9100 is configured to receive data from the tag 9200 and transmit the received data to the transceiver or reader 9300. The antenna 9100 may be set to the same inductance for tags 9200 of different types of patient interfaces 3000 so that the antenna 9100 is compatible with various patient interfaces 3000. The transceiver 9300 may be physically operably connected to the antenna 9100 (e.g., via a wire) and may be located on or within the air circuit 4170 or adapter 9400. In one configuration, the transceiver 9300 may be located on or within the RPT device 4000. In one configuration, the transceiver 9300 may be external to the respiratory therapy system 8000. For example, the transceiver 9300 may be a scanner, smartphone, tablet, or any other device configured to receive transmitted RFID signals from an RFID tag or antenna. Thus, the antenna 9100 is configured to communicate data received from the tag 9200 with the transceiver 9300. The transceiver 9300 may also be configured to save or store the transmitted data from the antenna 9100.

[0413] 5A , the transceiver 9300 may include, for example, a controller on a flexible circuit mounted 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 incorporated as part of the RPT device 4000. The controller may function as described above. The transceiver 9300 may be configured to emit an electromagnetic field at an appropriate frequency, for example, 13.56 MHz, to read the tag 9200 from the patient interface 3000 or an accessory coupled to the patient interface 3000. The accessory may include, for example, but is not limited to, one or more of the patient interface's headgear, cushion, heat and moisture exchanger or waterless humidifier, air filter, air conduit, or adapter.

[0414] In some configurations, the transceiver 9300 may be configured to transmit data to the RPT device 4000 physically (e.g., via wires) or wirelessly. The RPT device 4000 may also be configured to save or store transmitted data from the transceiver 9300, interpret the transmitted data, and / or send alerts or signals to a user or caregiver, as described above. In some embodiments, the RPT device 4000 may also be configured to automatically modify one or more characteristics of the respiratory pressure therapy, for example, based on raw and / or interpreted data received from the transceiver 9300. Additionally or alternatively, the RPT device 4000 may be configured to suggest one or more therapy settings, for example, to facilitate patient care and / or patient comfort, based on interpreted data from the transceiver 9300, as described further below.

[0415] 5B shows an alternative configuration of respiratory therapy system 8000'. Respiratory therapy system 8000' may include any of the features described above with respect to respiratory therapy system 8000, except as described below. For example, respiratory therapy system 8000' includes patient interface 3000 and respiratory pressure therapy (RPT) device 4000 fluidly coupled by air circuit 4170. Respiratory therapy system 8000 further includes an RFID system 9000'.

[0416] Similar to the RFID system 9000 described above with respect to FIG. 5A , the RFID system 9000′ includes a tag 9200, an antenna 9100, and a transceiver 9300. In comparison, in the configuration shown in FIG. 5B , an adapter 9400 is configured to be fixedly or detachably coupled between the air circuit 4170 and the patient interface 3000. The adapter 9400 may include the antenna 9100 or may include the antenna 9100. Thus, the adapter 9400, and thus the antenna 9100, may be a separate component independent of, for example, the air circuit 4170 and the patient interface 3000. In that manner, the adapter 9400 may be used in combination with various air circuits 4170 or may be used to retrofit an air circuit 4170 without the antenna 9100. In some embodiments, the adapter 9400 may be reusable and the air circuit 4170 may be replaceable. The antenna shown in FIG. 5B may have any or all of the characteristics of the antenna 9100 described above with respect to FIG. 5A . In some aspects of the present technology, the adapter 9400 may also include one or more sensors.

[0417] Various types of sensors may be used in connection with the technology described herein. Any or all of the sensors may be configured to generate a signal based on, indicative of, or reflective of one or more physical phenomena. Example types of sensors (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 may be used in connection with the technology described herein. Any or all of the sensors described herein may communicate a signal based on the sensed physical phenomenon via wired communication and / or via wireless communication. Any or all of the sensors described herein may be included as part of adapter 9400 (e.g., as sensor 9504), which is discussed in more detail elsewhere herein. Any or all of the sensors described herein may be located in different locations relative to an example respiratory therapy system and its components. For example, a first sensor may be located in the RPT device, another sensor in the patient interface, and yet another sensor in the air conduit. Other examples of placement of one or more sensors are described herein.

[0418] The adapter 9400 may be in fluid communication with the air circuit 4170 and the patient interface 3000. As such, 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 to the patient interface 3000. Furthermore, the adapter 9400 forms a fluid-tight seal between the air circuit 4170 and the patient interface 3000. To achieve a fluid-tight seal, in some configurations, a proximal portion of the air circuit 4170 may extend at least partially into a distal portion of the adapter 9400, for example, through a 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, a distal opening of the patient interface 3000 may extend at least partially into a proximal opening of the adapter 9400.

[0419] 6A and 6B show perspective views of a proximal portion 4170A of the air circuit 4170. For example, the air circuit 4170 shown in FIGS. 6A and 6B may be used with the system 8000 or system 8000′ shown in FIGS. 5A and 5B, respectively. The air circuit 4170 is a conduit or tube that, in use, is constructed and arranged to allow airflow to travel between two respiratory therapy system components, such as the RPT device 4000 and the patient interface 3000. While not shown, in some cases, there may be separate limbs of the air circuit 4170 for inhalation and exhalation. In other cases, the air circuit 4170 may be a single limb and used for both inhalation and exhalation.

[0420] The proximal portion 4170A of the air circuit 4170 may include a proximal-most end comprising a cover 4172. The cover 4172 may be directly or indirectly coupled to the proximal portion 4170A of the air circuit 4170. The cover 4172 may include one or more features 4174 extending outward from the 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 (shown in FIG. 5A ) or between the air circuit 4170 and the adapter 9400 (shown in FIG. 5B ). For example, the feature 4174 may include a bayonet-style connector including protrusions and / or grooves configured to engage with corresponding protrusions and / or grooves on the patient interface / adapter by turning the connector until latched. In an alternative example, the feature 4174 may include an isotaper configured to connect to the patient interface / adapter. However, it should be understood that the feature 4174 may include other suitable configurations (eg, a releasable snap fit connector) to facilitate connection to a patient interface / adapter.

[0421] The cover 4172 further includes an opening 4176. The opening 4176 extends entirely through the cover 4172 and is in fluid communication with the lumen 4178 of the air circuit 4170. The cover 4172 and / or the inner surface defining the lumen 4178 of the air circuit 4170 may include one or more protrusions, or projections 4190. The protrusions 4190 may extend radially inward, for example, from the inner surface defining the lumen 4178 and / or from the inner surface 4179 of the cover 4172 into the lumen 4178. The protrusions 4190 may extend partially or completely through the lumen 4178. As described below with reference to FIG. 6B , the protrusions 4190 may include an enclosure 4199 or may mate with a seal 4199. Although not shown, the protrusions 4190 may include one or more sensors. The sensor(s) may be used to identify, characterize, or define various aspects of the fluid (e.g., air, gas, etc.) within the air circuit 4170. For example, the protrusion 4190 may include sensor(s) for identifying the temperature, humidity level, air flow rate, pressure, etc. of the fluid within the air circuit 4170. The sensor(s) may be in communication with the RPT device 4000, the antenna 9100, and / or the transceiver 9300.

[0422] 6B shows a proximal portion 4170A of a version of the air circuit 4170 with the cover 4172 removed. The circuit board 4192 may be disposed within the cover 4172, for example, between the outward-facing surface of the air circuit 4170 and the inward-facing surface of the cover 4172. The circuit board 4192 may be configured to surround a protrusion 4170C extending proximally from the proximal-most surface 4170B of the air circuit 4170. Although not shown, the protrusion 4170C may include one or more features (e.g., indentation(s), protrusion(s), etc.) to help support and / or secure the circuit board 4192 in place (e.g., around the protrusion 4170C). For example, the protrusion 4170C may include a first feature (e.g., a recess, a protrusion) for coupling the proximal portion 4192A of the circuit board 4192 to the protrusion 4170C, and / or a second feature (e.g., a recess, a protrusion) for coupling the distal portion 4192B of the circuit board 4192 to the protrusion 4170C.

[0423] The surface 4195 of the circuit board 4192 defining the platform 4196 is configured to face proximally. For example, the surface 4195 is configured to lie in a plane that is approximately perpendicular to an axis A extending longitudinally from the proximal end to the distal end of the air circuit 4170. In this manner, 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 further comprises an antenna 4100. The antenna 4100 may have any or all of the characteristics of the antenna 9100 described above with respect to FIGS. 5A and 5B . The platform 4196 comprises an opening 4198 extending entirely through the platform 4196. The opening 4198 may be configured to allow fluid flow through the lumen 4178 of the air circuit 4170. Thus, opening 4198 may have the same or a different diameter as lumen 4178 of air circuit 4170. Cover 4172 is removed from Figure 6B to show this example arrangement of antenna 4100 integrated into air circuit 4170, however, in use, cover 4172 obscures antenna 4100 from view, as shown in Figure 6A.

[0424] The encapsulation 4199 may house one or more sensors, such as those described above (e.g., sensors within the protrusion 4190). In some examples, the encapsulation 4199 may be formed from additive manufacturing techniques (e.g., 3D printing). The encapsulation 4199 may be formed of any suitable material, for example, a transparent material such as silicone. The encapsulation 4199 may surround and seal the sensor, holding the sensor in place. In the alternative, a single sealing portion 4199 may encapsulate multiple sensors. In a further alternative, the proximal portion 4170A may include multiple encapsulations 4199, each surrounding one or more sensors.

[0425] Figure 6C shows a front view of the circuit board 4192 in a first, or flattened, configuration. As previously described with reference to Figure 6B, 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 (as shown in Figure 6B). Thus, the circuit board 4192 may be composed of one or more bendable or flexible materials.

[0426] The bridge 4194 is configured to provide a physical connection between the circuit board 4192 and the platform 4196. As shown in FIG. 6B , the bridge 4194 is formed of a bendable or flexible material to allow the platform 4196 to bend approximately 90 degrees. The bridge 4194 may have the same thickness as the circuit board 4192 and / or the platform 4196, or may have a smaller thickness than the circuit board 4192 and / or the platform 4196. The smaller thickness of the bridge 4194 may allow the bridge 4194 to bend more and / or bend more easily. Additionally or alternatively, the bridge 4194 may be composed of the same material as the circuit board 4192 and / or the platform 4196, or may be composed of a different material. For example, the bridge 4194 may be composed of a material having more flexible properties compared to the circuit board 4192 and / or the platform 4196. When utilized with the air circuit 4170, the opening 4198 of the platform 4196 may be positioned coaxially with the lumen 4178 of the air circuit 4170 such that the platform 4196 is located at the proximal end of the protrusion 4170C. As shown in FIG. 6B, the bridge 4194 may be bent relative to the platform 4196, and the circuit board 4192 may be bent to wrap around the protrusion 4170C.

[0427] Antenna 4100 is fixed to platform 4196 and is electrically coupled to circuit board 4192, for example, via bridge 4194. Antenna 4100 surrounds or encircles opening 4198. Thus, antenna 4100 surrounds or encircles the proximal opening of lumen 4178 of air circuit 4170, as shown in FIG.

[0428] The antenna 4100 may be formed by various methods or combinations of methods. The antenna 4100 may include a flexible circuit that connects directly to the main flexible circuit of the transceiver 9300, which may connect to the air circuit 4170. The antenna 4100 may be formed from one or more conductive, e.g., copper, wires welded, soldered, glued, or otherwise affixed to the periphery of the platform 4196 or the air circuit 4170. The conductive wires may be affixed to the transceiver module on the circuit board. The antenna 4100 may alternatively be formed, for example, via printed conductive, e.g., silver ink or printed conductive thread, applied directly onto the platform 4196 or the periphery of the air circuit 4170. The antenna 4100 may be formed of a flexible printed circuit (FPC), coiled wire, or conductive printing or plastic. Laser direct structuring (LDS) may be applied over a plastic encapsulation that may protect the electronic components. The LDS may be bonded, welded, or soldered to the transceiver module on the circuit board, for example. Thus, for example, the antenna 4100 may be mounted directly to the platform 4196 .

[0429] The magnetic field strength of the passive tag 9200 is directly proportional to the distance between the passive tag 9200 and the antenna 9100. For example, the magnetic field strength of the passive RFID tag 9200 decreases as the tag 9200 moves away from the antenna 9100. Conversely, the magnetic field strength of the passive tag 9200 increases as the tag 9200 moves closer to the antenna 9100. This is because, as described above, the passive tag 9200 obtains the energy necessary to transmit radio waves from the magnetic field in which it operates. In other words, the passive tag 9200 and the antenna 9100 operate according to the principle of inductive coupling. The RFID system 9000 shown in FIGS. 5A and 5B operates on this principle. Therefore, the placement of the antenna 9100 relative to the tag 9200 affects the operability of the RFID system 9000 within the system 8000.

[0430] As previously mentioned, the tag 9200 may 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 may vary depending on the type or size of the patient interface 3000 used by the patient. As shown in FIGS. 4J-4P and described above, the patient interface 3000 may have a variety of different configurations and components. The type or location of the tag 9200 may be customized for different patient interface designs, for example, to fit the antenna 9100 or to position the tag 9200 within a proper reading direction or angle. The antenna 9100 and tag 9200 may be positioned near where the air circuit 4170 is coupled to the patient interface 3000, and may be positioned to avoid contact with the patient's skin or to avoid the vent contact area during use. The system 8000 described herein may be used with a variety of patient interface types, such as a tube-up nasal patient interface (e.g., having any of the characteristics of patient interface 3000-3 of FIG. 4L), a tube-down nasal patient interface (e.g., having any of the characteristics of patient interface 3000-4 of FIG. 4M), a tube-up full-face patient interface (e.g., having any of the characteristics of patient interface 3000-1 of FIG. 4J), or a tube-down full-face patient interface (e.g., having any of the characteristics of patient interface 3000-2 of FIG. 4K).

[0431] Figures 7A and 7B illustrate an exemplary patient interface 3000'. The patient interface 3000' may be used, for example, as the patient interface 3000 of system 8000 or system 8000' described above with reference to Figures 5A and 5B, respectively. Figure 7A is a front view of the patient interface 3000', and Figure 7B is a side view of the patient interface 3000'. The patient interface 3000' may be commonly known 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 may be configured to cover only the patient's nose.

[0432] 7A and 7B include stippling to better illustrate and explain the various portions of the patient interface 3000' described herein. However, the stippling is for illustrative purposes only and does not necessarily represent that different portions of the patient interface 3000' comprise different materials, properties, or colors, although in one example, different portions may comprise different materials, properties, or colors.

[0433] 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' may differ significantly from the size and shape shown in FIGS. 7A and 7B. Portions of the patient interface 3000' may be formed from a hard or rigid material, while other portions of the patient interface 3000' may be formed from a soft or flexible material. Thus, placing an RFID tag, such as tag 9200, on the patient interface 3000' presents unique considerations.

[0434] The patient interface 3000′ includes a shell 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 shell 3002 (e.g., the first portion 3002A, the second portion 3002B, and the third portion 3002C) may be formed of a hard material (e.g., polycarbonate) and may not contact the patient's skin. One or more portions of the shell 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 only through the entire thickness of the shell 3002 and is configured to directly or indirectly couple the patient interface 3000′ to a proximal portion of the air circuit 4170. The opening 3008 aligns with a 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.

[0435] Because the antenna 9100 (4100 in FIGS. 6B and 6C) may be located in or on the proximal portion of the air circuit 4170, which is coupled to the patient interface 3000′ via the opening 3008, the tag 9200 may be located near the opening 3008 in a “tube-down” configuration of the patient interface 3000′, as shown in FIG. 7A (FIGS. 4K and 4M also show similar “tube-down” configurations where the tag 9200 may have a similar location). For example, the tag 9200 may be coupled to any of the first portion 3002A, second portion 3002B, third portion 3002C, or fourth portion 3002D. In some embodiments, the tag 9200 may be located on or near the third portion 3002C, which may be ideally positioned for the patient interface 3000′ due to its proximity to the opening 3008. The third portion 3002C is near or adjacent to the mid-plane M. For example, the tag 9200 may be positioned on one side (i.e., left or right side) defined by the midplane M, or on the other side (i.e., right or left side) defined by the midplane M, or along the midplane M. In some configurations, the tag 9200 may be positioned across multiple portions of the patient interface 3000'. For example, a first portion of the tag 9200 may be on the first portion 3002A of the shell 3002, and a second portion of the tag 9200 may be on the second portion 3002B and / or the third portion 3002C of the shell 3002. In this manner, the positioning of the tag 9200 may vary between the first portion 3002A, the second portion 3002B, the third portion 3002C, and / or the fourth portion 3002D.

[0436] The tag 9200 may be disposed on or within the shell 3002 by various means. For example, the tag 9200 may be a chip overmolded within the shell 3002. Alternatively, the tag 9200 may be printed directly onto the shell 3002 via a printed conductive material, such as silver ink. The tag 9200 may be an inlay label overmolded within the shell 3002. In such an example, the tag 9200 (e.g., an inlay label) may be inserted into a cavity of a mold for the shell 3002, for example, by automation, and an injection mold and plastic may be injected over the inlay label, thus securing the inlay label within or onto the shell 3002. Alternatively, the tag 9200 may be formed of conductive silicone and / or conductive thread printed on the shell 3002. As a further alternative, the tag 9200 may be formed of a conductive fabric having stretchable copper traces. Thus, the tag 9200 may be formed by any one of these methods, or any combination of these methods, including methods commonly known in the art. Furthermore, the tag 9200 may still be a separate component secured to the shell 3002 by a variety of suitable means commonly known in the art, including, but not limited to, adhesive and / or one or more mechanical fasteners.

[0437] The patient interface 3000′ further includes a cushion 3006 configured to contact the patient's face. The cushion 3006 may be formed of a soft or flexible material, such as silicone rubber. The cushion 3006 is configured to form a seal against the patient's face. The tag 9200 may be disposed on or within the cushion 3006; however, due to challenges related to the distance of the cushion 3006 from the opening 3008 and / or challenges related to one or more properties of the material comprising the cushion 3006 (e.g., the flexibility, softness, thickness, etc.), disposing the tag 9200 on or within the cushion 3006 may be less desirable. Additionally or alternatively, disposing the tag 9200 on or within the cushion 3006, for example, between the patient's skin and the cushion 3006, may cause discomfort to the patient. That is, disposing the tag 9200 within the cushion 3006 is also possible.

[0438] 7A and 7B show a tube-down patient interface 3000' and discuss the location of the tag 9200 near the opening 3008, a tube-up patient interface may also be used in accordance with this technique. In a tube-up patient interface 3000', the location of the tag 9200 may be located closer to an upper region of the patient interface 3000', for example. In some embodiments, the location of the tag 9200 on the patient interface 3000' may depend, at least in part, on whether a tube-up or tube-down configuration is utilized with the patient interface 3000', such that the tag 9200 is closer to a proximal portion of the air circuit 4170 and the antenna 9100 when attached to the patient interface 3000'.

[0439] 8A and 8B show an alternative exemplary patient interface 3000''. The patient interface 3000'' may be used in conjunction with, for example, system 8000 or system 8000' described above with reference to FIGS. 5A and 5B, respectively. FIG. 8A shows a rear view of the patient interface 3000'' and FIG. 8B shows a top view of the patient interface 3000''. The patient interface 3000' may be commonly known as nasal pillows. For example, the patient interface 3000'' may be configured to be partially inserted into the patient's nose.

[0440] 8A and 8B include stippling to better illustrate and explain the various portions of the patient interface 3000'' described herein. However, the stippling is for illustrative purposes and does not necessarily represent that different portions of the patient interface 3000'' comprise different materials, properties, or colors, although in one example, different portions may comprise different materials, properties, or colors.

[0441] 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 of soft or flexible materials, while other portions of the patient interface 3000'' may be formed of hard or rigid materials. For example, the portions of the patient interface 3000'' that contact the patient's face may be soft or flexible, while portions used to facilitate connection between the air circuit 4170 and the patient interface 3000'' may be hard or rigid. Thus, the patient interface 3000'' is smaller in size compared to the patient interfaces 3000' described above. Therefore, placing an RFID tag, such as tag 9200, on the patient interface 3000'' presents unique considerations.

[0442] The patient interface 3000'' includes a first nasal cushion 3012A and a second nasal cushion 3012B on either side of a central plane M. For example, the first nasal cushion 3012A is on a first side (e.g., left or right) of the central plane M, and the second nasal cushion is on a second side (e.g., right or left) of the central 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 nares and thus contact the skin. Accordingly, the material comprising the first nasal cushion 3012A and the second nasal cushion 3012B may be soft and flexible (e.g., silicone rubber). Additionally, the first nasal cushion 3012A and the second nasal cushion 3012B include a first hole 3014A and a second hole 3014B that extend through the entire thickness of the first nasal cushion 3012A and the second nasal cushion 3012B, respectively, such that the first nasal cushion 3012A and the second nasal cushion 3012B are in fluid communication with 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.

[0443] The first nasal cushion 3012A and the second nasal cushion 3012B extend radially outward from the first portion 3018A. The first portion 3018A may be constructed of the same or a different material as the first nasal cushion 3012A and the second nasal cushion 3012B. The first nasal cushion 3012A and the second nasal cushion 3012B are configured to form a seal with the patient's skin.

[0444] The second portion 3018B is on either side of the first portion 3018A. For example, the second portion 3018B is on the left and right sides of the first portion 3018A. The second portion 3018B may be made of the same material as the first portion 3018A or a different material. The second portion 3018B is not configured to form a seal with or contact the patient's skin.

[0445] The third portion 3018C is located outside each of the second portions 3018B. For example, the third portion 3018C is to the left of the first portion 3018A and to the right 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. Thus, the third portion 3018C may be constructed of a harder or more rigid material. In a tube-down patient interface 3000'', the air circuit 4170 may be connected to the patient interface 3000'' at the first portion 3018A generally opposite the first nasal cushion 3012A and the second nasal cushion 3012B. Alternatively, in a tube-up patient interface 3000'', the air circuit 4170 may be attached to conduit headgear, which may be attached to the third portion 3018C. In some embodiments, the location of the tag 9200 on the patient interface 3000'' may depend, at least in part, on whether a tube-up or tube-down configuration is utilized on the patient interface 3000'', such that the tag 9200 is closer to the proximal portion of the air circuit 4170 and antenna 9100 when attached to the patient interface 3000''.

[0446] When utilizing the patient interface 3000'', the air circuit 4170 having the antenna 9100 may be connected to the patient interface 3000''. The tag 9200 may be positioned near the connection site of the air circuit 4170. For example, the tag 9200 may be coupled to the first portion 3018A, the second portion 3018B, or the third portion 3018C. In some embodiments, the tag 9200 may be coupled to the second portion 3018B or the third portion 3018C to avoid contact with the patient's skin. 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 tag 9200 may be on the second portion 3018B, and the second portion of the tag 9200 may be on the third portion 3018C. In this manner, the location of the tag 9200 can vary between the first portion 3018A, the second portion 3018B, and the third portion 3018C.

[0447] Placing the tag 9200 on or within the first nasal cushion 3012A, the second nasal cushion 3012B, and / or, in some embodiments, 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 related to one or more properties of the material comprising the first nasal cushion 3012A and the second nasal cushion 3012B (e.g., the flexibility, softness, thickness, etc. of the material). Additionally or alternatively, placing the tag 9200 on or within the first nasal cushion 3012A and the second nasal cushion 3012B, for example, between the patient's skin and the first nasal cushion 3012A or the second nasal cushion 3012B, may be uncomfortable for the patient.

[0448] The tag 9200 may be positioned on or within the patient interface 3000′ by various means similar to those described above with respect to securing the tag 9200 to the patient interface 3000′. For example, the tag 9200 may be a chip overmolded within the tubular portion 3018. Alternatively, the tag 9200 may be printed directly onto the tubular portion 3018 via a printed conductive, e.g., silver, ink. The tag 9200 may be an inlay label overmolded within the tubular portion 3018. In such an example, the tag 9200 (e.g., an inlay label) may be inserted into a cavity of a mold for the tubular portion 3018, e.g., via automation, an injection mold, and plastic may be injected over the inlay label, such that the inlay label may be secured within or onto the tubular portion 3018. Alternatively, the tag 9200 may be formed of conductive silicone and / or conductive thread printed onto the tubular portion 3018. In a further alternative, the tag 9200 may be formed of a conductive fabric having stretchable conductive, e.g., copper, traces. Thus, the tag 9200 may be formed by any one of these methods, or any combination of these methods, including those commonly known in the art. Furthermore, the tag 9200 may still be a separate component secured to the tubular portion 3018 by a variety of suitable means commonly known in the art, including, but not limited to, adhesive and / or one or more mechanical fasteners.

[0449] During use of the patient interface 3000, 3000′, 3000″ or another suitable patient interface (collectively referred to as patient interfaces, where aspects described in connection with the patient interface 3000 may equally apply to the 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, e.g., 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 when 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 regarding the patient interface 3000 or the accessories. For example, the antenna 9100 in the air circuit 4170, or the adapter 9400, may be a detection tag 9200 in the patient interface 3000 and may read information about the patient interface 3000 associated with the tag 9200. Via the transceiver 9300, for example, this information may be transmitted to the RPT device 4000 (e.g., to the data communication interface 4280).

[0450] In some embodiments, the received information may be, for example, one or more of the type of patient interface 3000 being 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, set of respiratory therapy conditions for which the patient interface is suitable for use, etc.), a date or timestamp of use, a batch identification number of the patient interface 3000, or a serial identification number of the patient interface 3000. In some embodiments, the received information may be one or more of patient information, such as the type of therapy or therapy setting the patient is intended to receive, or other information. In some embodiments, the received information may be whether the air circuit 4170 and / or ancillary devices (not shown) are connected or disconnected to the patient interface 3000.

[0451] 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 receiving information, which may mean either that a controller incorporated as part of the RPT device 4000 (e.g., the central controller 4230 and / or the therapy control module 4330) causes the RPT device to perform the action, or that a controller separate from the RPT device 4000 causes the RPT device 4000 to perform the action. For example, the RPT device 4000 may automatically control the operation of a therapy provided to the patient based on information or signals received (e.g., via the central controller 4230 and / or the therapy control module 4330, as described above). For example, the RPT device 4000 may improve the breathing experience by determining whether the settings of the RPT device (e.g., gas flow rate, humidity level, etc.) are properly aligned with the patient interface worn by the patient. In some configurations, the RPT device 4000 may enable the design of ventilation ports and flow curves specific to the patient interface to facilitate the delivery of more comfortable and / or efficient therapy. In some embodiments of the present technology, instructions may be generated for the patient based on information received by the RPT device 4000. Instructions may be generated, for example, that an improper type or size of patient interface is being used, that the patient interface cushion or the entire patient interface needs to be replaced, that the RPT device 4000 is configured with one or more improper settings that should be changed by the patient, or other appropriate instructions. The instructions may be generated, for example, to an external device such as a remote external device 4286 or a local external device 4288 (e.g., the patient's tablet, smartphone, or computer, or a healthcare provider's device), to one or more of the RPT device 4000's display or other components of the system 8000.In other embodiments, respiratory therapy system 8000 may receive input from the patient, for example, the patient may input information regarding patient interface 3000 during a therapy session, and the input received from the patient may be compared to information received from patient interface 3000 in RFID system 9000 to verify the accuracy of the patient's input. In some embodiments, information received from RFID system 9000 may be used to track usage or other characteristics of the patient interface while it is in use.

[0452] In further 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 system 8000 or system 8000′ (collectively referred to as the system, with aspects described in connection with system 8000 also applicable to system 8000′). For example, a sensor or system configured to detect air flow, pressure, air leaks, humidity, or other characteristics of system 8000 may transmit information to the RPT device 4000. The RPT device 4000, in combination with one or more other sensors, may analyze or interpret information about the patient interface 3000 received from the RFID system 9000, 9000′ (collectively referred to as the RFID system, with aspects described in connection with RFID system 9000 also applicable to RFID system 9000′). For example, information about the type and size of the patient interface worn or the duration the patient interface has been in use may be received from the RFID system 9000. The system 8000 may also receive information regarding patient interface discomfort or the occurrence of leaks from other sensors or patient inputs.

[0453] The system 8000 may analyze this information together and take action based on the aggregated information. For example, if, based on information received from the RFID system 9000, the patient indicates discomfort with the patient interface or a leak is detected in the patient interface, the RPT device 4000 may generate instructions to the patient that they should use a different size or type of patient interface, that they should use a different size or type of cushion, or that they should use a new patient interface or cushion. The instructions may include, for example, suggestions regarding the type or size of patient interface or cushion to use, or guidance on how to select a more compatible type or size of cushion or patient interface. The instructions may be generated to an external device, such as a remote external device 4286 or a local external device 4288 (e.g., the patient's tablet, smartphone, or computer, or a healthcare provider's device), for example, on a display (e.g., display 4294) of the RPT device 4000 or one or more other components of the system 8000, as described above. In other embodiments, one or more settings of the RPT device 4000 may be altered based on aggregate information received from the RFID system 9000 and other information from the system 8000. In some embodiments, the indication may be that the air circuit 4170 is not coupled to the patient interface 3000 or is improperly coupled to the patient interface 3000.

[0454] In some embodiments, the system 8000 may instruct the patient that a new patient interface or cushion should be used when the patient interface or cushion has been worn for a sufficiently long time or has a sufficiently old manufacturing batch identification number or serial identification number that may have affected performance. In some embodiments, the age of the patient interface or the number of times the patient interface has been used may generate instructions indicating that a new patient interface or cushion should be used. The system 8000 may also instruct the patient to replace the patient interface or cushion. This instruction may also depend, at least in part, on the recommended duration of use of the particular patient interface or cushion type, the type of therapy being administered to the patient, or one or more other factors. The instructions may be generated, as described above, for example, on a display (e.g., display 4294) of the RPT device 4000 or other component of the system 8000, to an external device (e.g., a patient's tablet, smartphone, computer, or a healthcare provider's device) such as a remote external device 4286 or a local external device 4288, or to a cloud server such as a remote external communications network 4282 and / or a local external communications network 4284 and / or a remote external communications network 4282 (e.g., for remote monitoring purposes to improve the patient experience or to initiate an order (such as a new patient interface or accessory)).

[0455] In some examples, system 8000 and / or system 8000′ may include or communicate with (e.g., via the Internet or other data communications network) one or more external system(s) 9520, as shown in FIG. 39 . Illustrative examples of external system(s) include 4286 and 4288 discussed herein. Such external computer systems may, for example, be dedicated services and / or may be hosted on a cloud computing platform (e.g., AWS, Azure). Any or all of the analysis, processing, manipulation, and / or actions performed by system 8000 and / or system 8000′ (discussed herein) may instead be performed by or in conjunction with one or more computer systems. As an illustrative example, data may be received by the RPT device 4000 including: 1) data from tags included in the patient interface (e.g., data identifying what type of patient interface is being used and / or other data as discussed herein) or data from other components of the system 8000 or system 8000′; and 2) data from sensors (e.g., airflow, pressure, air leak, humidity, VOC sensors, etc.) related to the operation of the system 8000 (or 8000′). The RPT device 4000 may communicate such data to one or more computer systems for processing, analysis, etc. One or more data messages may then be communicated from the one or more computer systems back to the RPT device 4000 to, for example, effect a change or modification to its operation. The content and / or transmission of the data messages back to the RPT device may be based on the processing and / or analysis performed by the one or more computer systems.In some examples, any or all of system 8000 and / or the analysis or processing performed by 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.

[0456] The antenna 9100 and transceiver 9300 may read the signal from the tag 9200 at least once during a therapy session. For example, the tag 9200 may be read at the beginning of therapy, e.g., when a start button is pressed or an automatic start is initiated. In some embodiments, if no accessories or air circuits 4170 are detected attached to the patient interface 3000, then the RFID system 9000 may continue to read, for example, continuously or at regular intervals. In some configurations of the present technology, the signal from the tag 9200 may be read periodically, e.g., every few seconds, minutes, or hours. In some examples of the present technology, the antenna 9100 and transceiver 9300 may read the signal from the tag 9200 according to a regular or irregular frequency. For example, the signal may be read at a higher or lower frequency at the beginning of a session or after a predetermined time has elapsed. In some embodiments, the frequency may increase if an unexpected read occurs or if a read is unsuccessful. In some embodiments, the type of treatment being administered or the type of patient interface being used may at least partially determine how often the tag 9200 is read. In some examples, data may be obtained from the tag 9200 and / or sensor based on instructions generated or received, for example, from the RPT device 4000 and / or an external computing system hosted, for example, on a cloud computing platform. For example, a VOC sensor described herein may be used to obtain such data based on instructions received, for example, from a physician.

[0457] As described herein (see, e.g., FIG. 5B ), the RFID system may include an adapter 9400 forming a separate and distinct component configured to be fixedly or removably coupled between the air circuit 4170 and the patient interface 3000. The adapter 9400 may comprise or include an antenna 9100, a transceiver 9300, and / or one or more sensors. As such, the adapter 9400 may be used with various air circuits 4170 or may be used to retrofit an air circuit 4170 without an antenna, 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 examples, the antenna 9100, transceiver 9300, and / or one or more sensors of the adapter 9400 may have any or all of the characteristics of the antenna 9100, transceiver 9300, and / or one or more sensors described herein.

[0458] 11-38 show an air adapter tube 9400 (also referred to as an "adapter") in accordance with an example of the present technology. As shown, the air adapter tube 9400 includes a tubular body 9410 (or lumen) configured to transport 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 the patient interface 3000 (see, e.g., FIGS. 36-37), and the distal end 9430 is configured to connect to the air delivery tube 4170 (see, e.g., FIGS. 15-19, 33, and 35). In this manner, 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.

[0459] The tubular body 9410 includes a passage 9412 for directing air flow, one or more electrical conductors 9414 (e.g., copper or aluminum wire(s)), and spiral or helical ribs 9416, see, e.g., Figures 11, 12, 20, 21, and 31.

[0460] In one example, the tubular body 9410 may comprise a flexible material, e.g., the tube wall 9410 may comprise a flexible material configured to allow the tube wall to flex or bend during use. In one example, the outer surface of the tubular body may comprise or be covered with a woven material, e.g., the tube wall 9410 may comprise or be covered with a woven material, as shown in FIGS. 11-19 . For example, the tube wall 9410 may comprise a film (e.g., including a polymeric material) covered with a woven material. However, the tube wall may comprise other materials, e.g., polymers. In one example, the tube wall 9410 may comprise a woven material and may include, for example, a distinct color (e.g., blue) to clearly distinguish it from the air delivery tube 4170 and / or other tubes. The tube wall 9410 may include a circular cross-section as shown, although other shapes, e.g., oval, are also possible. In one example, the tubular body can have an inner diameter of between about 10-15 mm, e.g., 12 mm, so that the air adapter tube is flexible, slinky, and lightweight, improving the user experience. In one example, the inner diameter is at least 12 mm, e.g., 12-15 mm, to reduce impedance. In one example, the tubular body can have a length of between about 5-15 cm, e.g., 8-10 cm, 8.5-10 cm, or 8.5 cm. In one example, the length is between 8.5-10 cm (e.g., at least 8.5 cm, about 8.5 cm), for example, to allow the air adapter tube to hang vertically downward from the patient interface during use and prevent the air adapter tube from acting like a lever arm and / or the weight of the air adapter tube from creating tube resistance that could adversely affect the seal at the patient interface.

[0461] The one or more electrical conductors 9414 are configured to carry or transmit an electrical signal and / or power. The one or more electrical conductors 9414 may extend the entire length of the tubular body 9410, for example, to provide heat along (partially or entirely) the length of the air adapter tube 9400 and / or to transmit electrical signal(s) and / or power from the proximal end 9420 to the distal end 9430 (e.g., from a sensor disposed at the proximal end 9420).

[0462] In one example, the tubular body 9410 may have four electrical conductors 9414, although more or fewer conductors are possible, e.g., two, three, or more. 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, two electrical wires may be provided for heat, if desired. That is, if heating of the tubular body is not provided or required, the tubular body may include only two wires, one for power and one for data / signal. In one example, each electrical conductor may include 30 AWG (American Wire Guage) wire, although alternative wire gauges are possible.

[0463] In one example, the helical rib 9416 is spirally wound along the length of the tube wall 9412, e.g., along the outer surface of the tube wall. The helical rib 9416 may be integrally formed with the tube wall 9412 (e.g., a woven or polymeric material) or may be formed separately and connected thereto. The helical rib 9416 is configured to increase the rigidity of the tube wall and / or provide additional thermal insulation. Furthermore, the helical rib 9416 is configured to provide a covering to, i.e., surround, one or more electrical conductors 9414 to insulate and / or protect the conductors.

[0464] The proximal end 9420 of the air adapter tube 9400 is configured to be repeatably connectable to and detachable from the patient interface 3000 to facilitate a releasable or separable connection between the air adapter tube 9400 and the patient interface 3000. When the air adapter tube 9400 and the patient interface 3000 are connected to one another, the proximal end 9420 is configured to form a substantially fluid-tight seal with the patient interface 3000.

[0465] In the illustrated example, the proximal end 9420 includes a cuff portion 9440 (also referred to as a pre-cuff portion) and a mechanical connector (e.g., a clip member 9450) configured to connect to a patient interface. In the illustrated embodiment, as shown in Figures 20 and 21, the clip member 9450 comprises a separate and distinct structure from the cuff portion 9440; i.e., the cuff portion 9440 and the clip member 9450 comprise separately molded components that are subsequently connected to one another. In the illustrated example, the clip member 9450 is configured to provide a releasable connection with the cuff portion 9440, e.g., a releasable snap-fit ​​connection or a separable snap-joint assembly.

[0466] As shown, the cuff portion 9440 includes one or more recesses 9442 configured to receive the clip member 9450; i.e., an upper recess 9442U extending along the top of the cuff portion 9440 leads to side recesses 9442S on each side of the cuff portion 9440 (see, e.g., FIGS. 20-21 ). Each of the side recesses 9442S forms a separate recess configured and arranged to interact with a respective lug 9452 of the clip member 9450 to facilitate retention of the clip member 9450 on the cuff portion 9440 (see, e.g., FIG. 11 ). When connected, the clip member 9450 is positioned along the outer surface of the cuff portion 9440, outside of the air flow path formed by the cuff portion 9440.

[0467] The cuff portion 9440 also includes a tubular end portion 9445 configured to extend at least partially into a connection port 3600 of the patient interface 3000 to form a substantially fluid-tight seal with the patient interface 3000 for delivery of pressurized gas (see, e.g., FIGS. 36-37 ). In an alternative example, the connection port 3600 may extend at least partially into the cuff portion 9440 to form a substantially fluid-tight seal.

[0468] The clip member 9450 includes a pair of resilient quick-release pinch arms or clips 9454 and a connecting portion 9456 connecting the pinch arms 9454 to each other. Each of the pinch arms 9454 includes a catch portion 9454C and a button or finger portion 9454B. The pinch arms 9454 are structured and arranged to provide a separable snap-fit ​​connection or separable snap-joint assembly with the patient interface, for example, the catch portion 9454C is configured to deflect and snap into a clip channel 3605 along the connection port 3600 of the patient interface 3000 (see, e.g., FIG. 36 ). The button portion 9454B is structured and arranged to be manually pinched or squeezed to deflect the catch portion 9454C for separation or release of the catch portion from the patient interface 3000, thus enabling separation of the air adapter tube 9400 from the patient interface 3000 (see, e.g., FIG. 37 ). In the example shown, each catch portion 9454C includes a lead-in angle to facilitate push-on assembly and a 90° return angle to resist or prevent pull-on disassembly, e.g., a user must deflect the catch portion via a button portion to enable disconnection. Each pinch arm 9454 also includes a lug 9452 to facilitate retention of the clip member 9450 on the cuff portion 9440 (see, e.g., FIG. 11 ).

[0469] In the example shown, the clip member 9450 comprises an open-ended configuration having a semi-flexible, generally semicircular connecting portion 9456, which allows the clip member 9450 to be connected to the cuff portion 9440, for example, in a manner similar to a circlip. When connected, the connecting portion 9456 of the clip member 9450 is disposed within an upper recess 9442U of the cuff portion 9440 (see, for example, FIGS. 12 and 34 ), and the pinch arms 9454 are disposed along each side of the cuff portion 9440, with the lugs 9452 fitting into respective side recesses 9442S of the cuff portion 9440, to positively and releasably interconnect the clip member 9450 and the cuff portion 9440 in the assembled position (see, for example, FIG. 11 ). In an alternative example, the clip member 9450 may be permanently or permanently connected to the cuff portion 9440. Alternatively, the clip member and cuff portion may be integrally formed as a unitary structure.

[0470] In one example, the connection port 3600 of the patient interface 3000 forms a clip channel 3605 (e.g., via a flange along the connection port as shown in FIGS. 36-37 ) configured to matingly receive the catch portion 9454C of the clip member 9450. For example, the clip channel 3605 can be configured to receive a respective rib or catch of the catch portion 9454C to releasably retain the air adapter tube 9400 to the patient interface 3000 and form a swivel connection, e.g., allowing 360° free rotation of the air adapter tube 9400 relative to the patient interface 3000 about the axis of the connection port 3600. The button portion 9454B can be manually pinched or squeezed to disengage the catch portion 9454C from the clip channel 3605 (see, e.g., FIG. 37 ).

[0471] 36 , when the air adapter tube 9400 is connected to the patient interface 3000, the tubular end 9445 of the cuff portion 9440 extends at least partially into the connection port 3600 such that at least a radially outward facing surface of the tubular end 9445 engages the connection port 3600 to form a substantially fluid-tight seal with the patient interface 3000 for delivery of pressurized gas. In one example, a tip of the tubular end 9445 may engage a portion of the connection port 3600 to form a seal with the connection port 3600.

[0472] The cuff portion 9440 also includes a radially outwardly extending flange or flanges 9446 (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, for example, Figures 36 and 37.

[0473] In one example, the air adapter tube 9400 may decouple the air delivery tube 4170 from the patient interface 3000, for example, to decouple resistance of the tube on the patient interface to prevent seal instability. For example, decoupling may be provided by a pinch arm 9454 that 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.

[0474] In an alternative example, instead of the clip member 9450, the mechanical connector of the air adapter tube 9400 may include an isotaper configured to connect with a patient interface with an interference or friction fit. For example, the cuff portion 9440 of the air adapter tube may include an isotaper configured to connect to the connection port 3600 of the patient interface 3000.

[0475] In the example shown, the proximal end 9420 includes one or more adapters for coupling the cuff portion 9440 and supporting or housing the antenna 9100, the transceiver 9300, and / or one or more sensors.

[0476] As shown in FIGS. 20 and 21, 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).

[0477] The first adapter element 9460 includes a body portion 9462 and a tubular projection 9464 extending proximally from the body portion 9462. The body portion 9462 is configured to connect to the second adapter element 9470, and the tubular projection 9464 is configured to support and / or hold the antenna 9100, the transceiver 9300, and / or one or more sensors.

[0478] The second adapter element 9470 is constructed and arranged to interconnect the first adapter element 9460 and the tube wall 9410 of the tubular body. For example, the second adapter element 9470 includes a first end 9471 that connects to the tube wall 9410 and the helical rib 9416; for example, the second adapter element 9470 is overmolded onto the tube wall 9410 (e.g., a film) and / or the helical rib 9416 such that the second adapter element 9470 connects and seals with the tube wall 9410 and / or the helical rib 9416. The second adapter element 9470 includes a second end 9472 (opposite the first end 9471) that connects to the body portion 9462 of the first adapter element 9460; for example, the second adapter element 9470 is overmolded onto 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 may be formed and connected to one another by other suitable means, for example, an overmolded connection, a mechanical connection, or integral formation in a unitary configuration.

[0479] In the illustrated example, the transceiver 9300 is provided on a printed circuit board (PCB) 9500. One example of a PCB 9500 is a flexible printed circuit (FPC) or flexible circuit board 9480. Similar to examples described herein (see, e.g., FIGS. 6A and 6B ), and referring, for example, to FIGS. 20-24 and 27-32 , the FPC 9480 includes one or more pliable or flexible materials configured and arranged to allow the FPC 9480 to flex or bend around the tubular protrusion 9464 of the first adapter element 9460.

[0480] As shown, the FPC 9480 includes a first end 9481 and a second end 9482 opposite the first end 9481. The first end 9481 and the second end 9482 each include a respective opening 9481o, 9482o (see, e.g., FIGS. 32 and 38). The FPC 9480 is configured to bend or flex around the outer cylindrical surface of the tubular projection 9464, with the first and second ends 9481, 9482 at least partially overlapping such that the retention member 9465 (extending radially outward from the tubular projection 9464) protrudes through one or both respective openings 9481o, 9482o, thereby supporting, retaining, aligning, and orienting the FPC 9480 in place on the first adapter element 9460; see, e.g., FIGS. 20, 21, and 32. That is, the first adapter element 9460 includes at least one feature (e.g., a fastener (e.g., a retaining member 9465) and / or an adhesive (e.g., silicone)) configured to support and retain the FPC 9480.

[0481] The tubular projection 9464 of the first adapter element 9460 also includes at least one port 9467 that allows at least one sensor (e.g., pressure sensor 9490) provided on 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 on the FPC 9480 to communicate with the flow of air passing through the air adapter tube 9400. In one example, silicone may be provided within the port 9467 to seal the sensor 9490.

[0482] A sensor support 9466 is also provided on the first adapter element 9460. The sensor support 9466 extends radially inward from the tubular projection 9464 and includes an internal recess configured to receive a sensor (e.g., a thermistor or air temperature sensor 9492) provided on the FPC 9480. In the example shown, the sensor support 9466 and respective temperature sensor 9492 (e.g., a thermistor) are in communication with the flow of air passing through the air adapter tube 9400 to, for example, measure the temperature of the air flow. In one example, the sensor support 9466 may be overmolded onto the temperature sensor 9492 of the FPC 9480.

[0483] In one example, pressure and temperature sensed by sensors 9490, 9492 may be provided to the FPC 9480. For example, electronic circuitry included in the air adapter tube 9400 may be used to read data from the sensors. The data is then converted by the electronic circuitry into a format and communicated to the controller (e.g., via electrical conductors 9414 (wires) and / or antenna 9100) to communicate data to the controller. In one example, the sensors included in the air adapter tube 9400 (e.g., including 9490, 9492) may be polled or otherwise communicate data at the same or different rates. In one example, any or all of the sensors in the air adapter tube 9400 may be polled continuously or less frequently (or on demand). As an illustrative example, the pressure sensor 9490 may be polled at a rate of 500 Hz or greater. The rate of polling for a given sensor may be based on how the data is used. In one example, polling some of the sensors included in the air adapter tube 9400 may be done at a lower frequency. For example, data from the inertial sensors may be polled at intervals such as one minute, as an illustrative example.

[0484] Data from the pressure and / or temperature sensed by sensors 9490, 9492 (or other sensors discussed herein) may be communicated to another system, such as an external computer system (e.g., a cloud computing platform, a mobile device, etc.), where it may then be processed or analyzed. The results of such processing or analysis may then be communicated back to and used by the RPT device 4000 and / or adapter (e.g., to control parameters related to the therapy provided to the patient).

[0485] In one example, pressure data from (or data based thereon) the pressure sensor 9490 may be communicated back to an RPT device or flow generator and used to control the pressure delivered to the patient. In one example, data acquired by the pressure sensor 9490 may be used for real-time control of the generated pressure. In one example, the pressure values ​​provided by the pressure sensor 9490 may be used in the same or similar manner as the pressure sensor 4272 discussed herein. In any example, the pressure values ​​provided by the pressure sensor 9490 may be used to calculate Pm or in connection with the interface pressure estimation algorithm 4312 as discussed herein. In one example, data from the pressure sensor 9490 may be used to compensate for air pressure errors in the air circuit (e.g., air circuit 4170).

[0486] The cuff portion 9440 is configured to connect to a first adapter element 9460. When connected, the cuff portion 9440 and the first adapter element 9460 form an annular space 9447 therebetween configured to receive an FPC 9480 that supports a pressure sensor 9490 and a temperature sensor 9492, see, e.g., FIGS. 31 and 34 .

[0487] 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 projection 9464 and / or along the outer periphery of the first adapter element 9460) to facilitate the ultrasonic welding process. For example, the energy directors can include raised beads (e.g., raised bead 9469b1 along the free end of the tubular projection 9464 and raised bead 9469b2 along the outer periphery of the first adapter element 9460, as shown in FIGS. 20, 27, and 34) to promote formation of a joint between the cuff portion 9440 and the first adapter element 9460 during the ultrasonic welding process.

[0488] In one example, at least one ventilation opening 9468 may be provided along the outer periphery of the first adapter element 9460, see, e.g., FIGS. 20, 22, 28, and 34. As shown, the ventilation opening 9468 includes a first end 9468.1 that communicates with the annular space 9447 that receives the FPC 9480 and a second end 9468.2 that communicates with the exterior of the air adapter tube, e.g., the surroundings. In one example, the first end 9468.1 may include a larger diameter than the second end 9468.2, and the ventilation opening 9468 may include a non-linear path from the first end 9468.1 to the second end 9468.2. In one example, a water-resistant pressure balancing membrane may be provided above the ventilation opening 9468, e.g., at the first end 9468.1. The water-resistant pressure balancing membrane may be configured to regulate the pressure differential at the proximal end 9420 (between the annular space 9447 and the ambient) and to prevent damage while resisting water / dust from entering the annular space along with the FPC 9480. That is, the water-resistant pressure balancing membrane ensures a balance of pressure between the annular space 9447 and the ambient so that the FPC 9480 and its sensor (e.g., pressure sensor 9490) can function reliably.

[0489] The distal end 9430 of the air adapter tube 9400 is configured to be repeatably connectable to and detachable from the air delivery tube 4170 to facilitate a releasable or separable connection between the air adapter tube 9400 and the air delivery tube 4170, see, for example, Figures 15-19. When the air adapter tube 9400 and the air delivery tube 4170 are connected to one another, the distal end 9430 is configured to form a substantially fluid-tight seal with the air delivery tube 4170.

[0490] In the illustrated example, the distal end 9430 includes a cuff portion 9432 and an electrical connector 9434 disposed, for example, on an upper side of the cuff portion 9432. The electrical connector 9434 includes one or more electrical contacts 9435, for example, a lead frame having four contacts, configured to transmit power and / or signals. The electrical contacts 9435 are electrically connected to respective electrical conductors 9414 (wires) extending along the tubular body 9410. The electrical connector 9434 is configured to electrically connect to a corresponding electrical connector 4175 of the air delivery tube 4170 (e.g., a heated air delivery tube).

[0491] The distal end 9430 of the air adapter tube 9400 includes a mechanical connector (e.g., recessed sides 9436) configured to mechanically connect to a corresponding mechanical connector (e.g., a pair of resilient quick-release pinch arms or clips 4177) on the air delivery tube 4170. Each of the pinch arms 4177 includes a catch portion 4177C and a button or finger portion 4177B. The pinch arms 4177 are structured and arranged to provide a separable snap-fit ​​connection or separable snap joint assembly with the distal end 9430, e.g., the catch portion 4177C is configured to flex and snap into a respective one of the recessed sides 9436, as shown in FIGS. The button portion 4177B is constructed and arranged to be manually pinched or squeezed to deflect the catch portion 4177C for separation or release of the catch portion from the distal end 9430, thus enabling separation of the air delivery tube 4170 from the air adapter tube 9400.

[0492] 25 and 26 , the mechanical connector (e.g., pinch arm 4177) of the air delivery tube 4170 may be configured as a separate and distinct clip member 4185 configured to provide a releasable connection with the cuff portion 4171 of the air delivery tube 4170, for example, similar to clip member 9450 described herein. For example, the clip member 4185 may be positioned within a recess in the cuff portion 4171 with lugs of the clip member 4185 fitting into respective side recesses to securely and releasably interconnect the clip member 4185 and cuff portion 4171 in the assembled position. In the alternative, the clip member and cuff portion may be integrally formed as a unitary structure.

[0493] However, it should be understood that the distal end 9430 and the air delivery tube 4170 may be connected to the air delivery tube 4170 by other suitable means. In the alternative, the distal end 9430 and the cuff portion 4171 may include an isotaper configured to connect to one another with an interference fit or a friction fit.

[0494] In the example shown, the air delivery tube 4170 does not include any sensors (e.g., temperature sensor, pressure sensor, etc.). In alternative examples, the air delivery tube 4170 may include at least one sensor (e.g., temperature sensor), for example, at least one sensor not provided on the air adapter tube 9400.

[0495] When the air delivery tube 4170 is connected to the air adapter tube 9400, the cuff portion 4171 includes a tubular end portion 4181 configured to extend at least partially into the opening 9437 of the cuff portion 9432 such that at least a radially outward facing 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 delivery of pressurized gas, see e.g., Figures 15, 16, and 35. In one example, a tip of the tubular end portion 4181 may engage a portion of the cuff portion 9432 to form a seal with the cuff portion 9432.

[0496] In the illustrated example, as shown in Figures 12, 15, 16, 25, and 26, the cuff portion 9432 includes a radially inwardly extending protrusion 9439 configured to engage with a corresponding recess 4189 in the tubular end 4181 when the air delivery tube 4170 is connected to the air adapter tube 9400, e.g., to facilitate alignment and prevent relative rotation.

[0497] In the example shown, the proximal end 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 pinch arms 9454, 4177 and tubular end portions 9445, 4181) configured to enable both the air adapter tube 9400 and the air delivery tube 4170 to form a mechanical and pneumatic connection 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.

[0498] In one example, as shown in Figures 12, 15, 17, 20, and 25, the cuff portion 9432 of the distal end 9430 may include an indicator or guide (e.g., alignment arrow 9433) configured to align with a corresponding indicator or guide (e.g., alignment arrow 4173) provided on the cuff portion 4171 of the air delivery tube 4170, for example, to facilitate and confirm correct orientation, alignment, and connection between the air adapter tube 9400 and the air delivery tube 4170.

[0499] 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 respective contacts on the electrical connector 4175 of the air delivery tube 4170 to form an electrical and control signal connection with the air delivery tube 4170, see, for example, FIG. 35 . In the example shown, the lead frame having the electrical contacts 9435 on the air adapter tube 9400 is arranged as a male connector configured to form an electrical and signal connection, i.e., a straight connection or a direct plug-in connection, when inserted into engagement with the electrical connector 4175 arranged as a female connector on the air delivery tube 4170. The electrical connector 4175 electrically connects its contacts with the respective electrical wires along the air delivery tube 4170. In one example, the electrical connection may be facilitated by using serial communications such as RS485. However, it should be understood that the electrical contacts may have alternative configurations and arrangements, depending, for example, on the interface arrangement or connection mechanism provided between the air adapter tube and the air delivery tube.

[0500] Electrical conductors 9414 (wires) running 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 signal(s) (e.g., from one or more sensors) may 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 an RPT device or flow generator (e.g., the RPT device or flow generator may be configured to be controlled based on output from the one or more sensors).

[0501] As described herein, the air adapter tube 9400 includes at least one sensor, e.g., a pressure sensor 9490, a temperature sensor 9492, supported at the proximal end 9420 by the FPC 9480. In examples, the at least one sensor may include the pressure sensor 9490 and / or the temperature sensor 9492 as described herein and may also include one or more additional sensors, e.g., a flow sensor, a humidity sensor, and / or an inertial sensor. The inertial sensor may include, for example, an accelerometer, a gyro sensor, a magnetometer, etc.

[0502] At least one sensor may generate one or more output signals that may be communicated to the controller for diagnosis and / or treatment of respiratory disorders. For example, the pressure sensor 9490 may be configured to generate a signal indicating the pressure of air passing through the proximal end 9420 for diagnosis and / or treatment of a respiratory disorder. The temperature sensor 9492 may be configured to generate a signal indicative of the temperature of the air at the proximal end 9420. The accelerometer sensor may be configured to generate a signal indicative of patient movement and / or the patient's sleeping position, and this data may be used to enable personalization of the patient interface based on detected sleep patterns.

[0503] In one example, the FPC9480 may be provided with a sensor, such as a CO2 sensor, a biomarker sensor, etc., configured to generate a signal indicative of exhaled gas and / or biomarkers of gas exhaled by the patient.

[0504] For example, the proximal end 9420 may include a CO sensor configured to detect CO accumulation, rebreathing CO levels, and / or respiratory comfort. In one example, the CO sensor is positioned in the patient interface between the patient and the vent of the patient interface, i.e., in a location that facilitates detection of gases exhaled by the patient. In one example, the sensor or vent may be moved or repositioned so that the CO sensor is positioned upstream of the vent, i.e., allowing exhaled gases to be detected by the sensor before they exit the patient interface through the vent. In one example, data from the CO sensor may be communicated to the RPT device and used, for example, to control (e.g., dynamically) the pressure delivered to the patient. In one example, if the CO measurement is high (e.g., above a threshold), then the pressure delivered from the RPT device may be increased. The resulting increased pressure (e.g., and corresponding flow rate) may act to reduce the patient's CO level.

[0505] In one example, the CO2 sensor may be configured to detect end-tidal CO2, which may be an indicator of a patient's health. For example, a low end-tidal CO2 reading may indicate poor perfusion, hypovolemia, or sepsis, while a high end-tidal CO2 reading may indicate airway narrowing, airway obstruction, or difficulty breathing. The end-tidal CO2 reading may also help medical personnel determine whether a patient is being adequately ventilated. In one example, the CO2 reading may be collected in the air adapter tube, meaning there is no need to place a CO2 sensor in the patient interface.

[0506] In one example, the proximal end 9420 may include a VOC (volatile organic compound) sensor configured to detect biomarkers in the patient's breath. For example, the VOC sensor may be configured to detect asthma, diabetes, lung cancer, alcohol, and other health conditions.

[0507] In one example, the CO2 and / or VOC sensor may be configured to perform measurements before treatment, i.e., the CO2 and / or VOC sensor may perform pre-treatment analysis before pressurized therapeutic air is delivered by the RPT device or flow generator. For example, a patient may wear the patient interface (operably connected to the RPT device via the air adapter tube 9400) for one or more breathing cycles (e.g., 1-10 breaths) before treatment begins, thereby allowing the CO2 and / or VOC sensor on the air adapter tube 9400 to perform analytical readings before the patient begins treatment. After one or more breathing cycles, the RPT device may be activated to deliver pressurized breathable air for treatment. In one example, readings from the CO2 and / or VOC sensor may be provided to the patient in real time or provided to a medical professional for analysis before communication to the patient. In this example, the patient interface is attached and therapy is delayed for one or more respiratory cycles to allow detection by one or more sensors (e.g., a CO2 sensor and / or a VOC sensor) to be completed.

[0508] In one example, readings from the CO2 and / or VOC sensor may be taken automatically at the start of therapy, before therapy begins, and / or before airflow is provided to the patient. In certain examples, a patient wearing a patient interface may be automatically detected (e.g., based on readings from an accelerometer, etc.) and then used to trigger the CO2 and / or VOC sensor (in whole or in part) to obtain data related to the patient's breathing. In one example, readings from the CO2 and / or VOC sensor may be taken as part of a startup process for the RPT device. The startup process may include additional aspects such as confirming the type of patient interface (via a tag as discussed herein), verifying firmware for the RPT device, and / or parameters used in the provided therapy. Thus, in certain examples, obtaining data from the CO2 and / or VOC sensor may be performed without, for example, explicitly prompting the patient to take such readings.

[0509] 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 power may be controlled via haptics based on an acceleration sensor. The air adapter tube 9400 may include a tube temperature increase / decrease button for controlling the air temperature of the delivered air. The air adapter tube 9400 may include a tube humidity increase / decrease button for controlling the air humidity of the delivered air. The air adapter tube 9400 may include an optical or color sensor for detecting one or more colors (e.g., color rings or grayscale gradients) on a portion of the patient interface or elbow, for example, to detect patient movement or sleep position. The air adapter tube 9400 may include an optical sensor for projecting light to encourage paced breathing. The air adapter tube 9400 may include a microphone for detecting, for example, snoring, mouth leaks, and voice commands.

[0510] In one example, ventilation may be transferred from the patient interface into the air adapter tube (e.g., in the proximal end 9420 adjacent the patient interface), and ventilation on the air adapter tube may be actively controlled (e.g., electrically and / or pneumatically).

[0511] In one example, the FPC 9480 includes an antenna 9100, such as a near-field communication (NFC) antenna. In one example, the antenna 9100 is configured to wirelessly transmit collected sensor data to an external device, including a smartphone or flow generator. As with the examples described herein, the antenna 9100 is configured to face proximally and lie in a plane generally perpendicular to the axis of the proximal end 9420. The antenna 9100 forms an opening that surrounds or encircles the lumen of the air adapter tube. The antenna 9100 is fixedly and electrically coupled to the FPC 9480 by a bridge 9494, which includes one or more flexible portions to allow the antenna to bend (e.g., approximately 90 degrees) relative to the FPC 9480; see, e.g., FIGS. 27-29 and 38 . The antenna 9100 may have any or all of the characteristics of the antennas described herein.

[0512] The antenna 9100 is positioned at the proximal end 9420 of the air adapter tube 9400 such that when the air adapter tube 9400 is coupled to the patient interface 3000, the antenna 9100 is positioned near the connection port 3600 of the patient interface 3000, see, for example, FIGS. 36-37. This positioning allows the antenna 9100 to receive data transmitted from a tag (which may be the same as or similar to tag 9200, e.g., an RFID tag, an NFC tag, etc.) provided on the patient interface 3000. FIGS. 36 and 37 show examples of where the tag 3607 may be positioned. The tag 3607 may be the same as or similar to tag 9200 and may be used in the methods described herein, such as to identify the patient interface and / or patient data.

[0513] In the shown example, 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, as shown in Figures 29 and 38, the FPC 9480 may include a joint region 9484 configured to allow the FPC 9480 to form a joint (e.g., a solder joint, a weld joint) with each of the electrical conductors 9414 (e.g., four wires).

[0514] In the illustrated example, the FPC 9480 includes straight sections that support the electronic components and at least one flexible bend section between the straight sections that allows the FPC 9480 to bend or flex around the first adapter element 9460. In one example, the electrical components may be provided on one or both sides of the FPC. In one example, the electronic components may include a pressure sensor 9490, a temperature sensor 9492, and / or an acceleration sensor configured to generate a signal indicative of the patient's sleeping position. In one example, the electronic components may include one or more sensors configured to generate a signal indicative of respiration and / or a biomarker indicative of the patient's health.

[0515] In the illustrated example, referring to, for example, FIGS. 36 and 37 , the air adapter tube 9400 is connected directly to the patient interface 3000 (i.e., there is no elbow or additional connector between the air adapter tube and the patient interface), thereby allowing one or more sensors (and antenna) provided on the FPC 9480 to be in close proximity to the patient interface and its breathing chamber for collecting data. However, it should be understood that the air adapter tube 9400 may be positioned in other suitable ways along the air delivery path between the patient interface and the RPT device. For example, the air adapter tube 9400 may be configured to connect to a tube-up patient interface and a tube-down patient interface according to any of the examples described herein. For example, the air adapter tube 9400 may be configured to connect between the patient interface 3000 and the air delivery tube 4170 (e.g., via an elbow) in the tube-down example shown in FIGS. 10B-10D , or the air adapter tube 9400 may be configured to connect between the headgear tube and the air delivery tube 4170 (e.g., via an elbow) in the tube-up example shown in FIG. 10A .

[0516] 39 is a block diagram illustrating an adapter 9400′, an RPT device 4000, a patient interface 3000, and one or more external systems 9520, all of which may communicate with each other using wired and / or wireless communication. The adapter 9400′ may be the same as or similar to the adapter 9400 discussed herein. Aspects of the adapter 9400 may be similarly applied to the adapter 9400′ and vice versa.

[0517] The adapter 9400' includes a PCB 9500, which may be flexible in certain examples. The adapter 9400' includes an antenna 9100 coupled to a transceiver 9300 configured to read data from a tag 9200 of the patient interface 3000. The antenna 9100 is electrically connected to the transceiver 9300, thereby emitting radio waves and may receive signals, for example, from the tag 9200.

[0518] The adapter 9400′ also includes one or more sensors 9504, a memory 9506, a transceiver 9508, and a controller 9502. The sensor(s) 9504 may include any or all of the sensors discussed herein. Examples of the sensor(s) 9504 include, for example, a pressure sensor 9490 and a temperature sensor 9492. The memory 9506 is provided for local recording (e.g., on the adapter 9400′) of data received from the sensors 9504, the transceiver 9300, etc. The memory 9506 may also store program instructions that can cause the controller 9502 to perform operations. In some examples, the memory may be part of the controller 9506 (e.g., a system-on-chip (SoC)). In any example, the adapter 9400' also includes a power management system configured to provide appropriate levels of power to one or more sensors 9504, memory 9506, transceiver 9508, controller 9502, and transceiver 9300.

[0519] A transceiver 9508 is associated with the adapter 9400′ to provide data communication functionality for communicating data between the adapter 9400′ and the RPT device 4000 (or other destination as needed). The transceiver 9508 may provide wired, wireless, or both wired and wireless communication. In some examples, the transceiver 9508 may be provided as part of the same circuitry as the transceiver 9300. Thus, for example, the adapter 9400′ may include a first transceiver that is wireless used to communicate with the tag 9200 and a second transceiver that is wired used to communicate with, for example, the RPT device 4000 using a physical link (e.g., a wire).

[0520] In one example, the transceiver 9508 provides a data link as described above and also provides power to the power management system of the adapter 9400'. Power may be provided from the RPT device (e.g., as discussed herein) or via a battery or other power source.

[0521] The adapter 9400′ also includes a controller 9502. The controller 9502 may include or be a hardware processor 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., data about a physical phenomenon or data from the tag 9200). In some cases, the controller 9502 controls when data is communicated 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 both programs and data), and I / O on a single integrated circuit. An example of a controller that may be used in the example adapter 9400′ is an STM32G071EBY6TR microcontroller.

[0522] In some examples, the controller 9502 may be used to determine when the patient interface is being worn or in use. This may be determined, for example, by interpreting data from an acceleration sensor to determine when the patient is wearing the patient interface 3000. Based on such a determination, the controller may activate one or more sensors to obtain data. For example, the CO2 and / or (VOC) sensors discussed herein may be activated to obtain their data. Such activation may occur before airflow is delivered to the patient. In some examples, the controller may activate the CO2 and / or (VOC) sensors when a reading from an airflow sensor (e.g., also provided in the adapter) indicates that airflow is not being delivered to the patient.

[0523] 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 of the sensors may be provided separately from the PCB 9500 and electrically coupled to the PCB by leads or the like. In other examples, such as shown in FIG. 38, the sensors (e.g., pressure sensor 9490) may be provided on the PCB. Note that the antenna may be partially (or wholly) integrated into the PCB 9500, in that it may be electrically connected to the transceiver 9300 provided on the PCB 9500.

[0524] The controller 9502 may provide different types of functionality, according to various exemplary embodiments. In some examples, the functionality of the controller 9502 may include pre- or post-processing of data acquired from the sensors and / or tag 9200. For example, various filtering, averaging, and / or other processing may be performed by the controller 9502. In other examples, the functionality of the controller 9502 may be more limited, in that data from the sensors is communicated back to the RPT device 4000 and processed by the controller 4230 on the RPT device 4000. Thus, in some examples, the controller 9502 may be responsible for processing or analyzing acquired data, while in other examples, the controller 9502 may be responsible for operating various components of the adapter 9400′ without performing such processing or analysis. Rather, such processing may be performed by the RPT device 4000 and / or the external system 9520.

[0525] As discussed herein, rather than a custom mechanical connection (e.g., a snap-fit ​​pinch arm), the proximal end 9420 and distal end 9430 of the air adapter tube 9400 may each include an isotaper configured to allow the air adapter tube 9400 to be connected between any patient interface and air delivery tube, i.e., the air adapter tube 9400 is not limited to connection with a patient interface or air delivery tube with a compatible mechanical connector. Additionally, rather than a custom electrical connection to 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 a lead frame / electrical contacts, i.e., the air adapter tube 9400 is not limited to connection with an air delivery tube with a compatible electrical connector. In such an 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. Also, any signal transmission may be provided by an antenna, such as, for example, NFC or Bluetooth. Such air adapter tubes 9400 are configured to fit different patient interfaces and air delivery tubes, thus providing an all-purpose tube that is not limited to a particular patient interface, air delivery tube, or system.

[0526] In the illustrated example, the air adapter tube 9400 is in the form of a short tube, e.g., between about 5 and 15 cm, e.g., between 8.5 and 10 cm in length. Alternatively, the air adapter tube may be in the form of a ring adapter, e.g., a cuff or ring similar in size to the proximal end 9420 (e.g., 1 to 4 cm). Such a ring adapter may include an FPC, one or more sensors, and an antenna within the cuff configured for connection between a patient interface and an air delivery tube. As described herein, such a ring adapter may include a power source (e.g., a rechargeable battery), allowing such a ring adapter to be versatile and adapted to different patient interfaces and air delivery tubes.

[0527] 5.5.1 Multi-directional antennas 9A-9D illustrate various configurations of one or more antennas 9100 and one or more tags 9200. Because the antennas 9100 and tags 9200 are inductively coupled to one another by a magnetic field, the antennas 9100 and tags 9200 may be configured within the RFID system 9000 to efficiently optimize the transfer of energy via the magnetic field. For example, the antennas 9100 and tags 9200 may be configured to optimize the read distance between the antennas 9100 and tags 9200. A non-optimized relative orientation may affect the read distance between the antennas 9100 and tags 9200.

[0528] 9A shows a first configuration in which the antenna 9100 is oriented substantially parallel to the tag 9200. For example, the antenna 9100 may be positioned facing the tag 9200. This configuration may optimize the magnetic field between the antenna 9100 and the tag 9200, thus allowing for an increased read distance between the antenna 9100 and the tag 9200. For example, the antenna 9100 and the tag 9200 may be spaced further apart from each other and still operate within the RFID system 9000. This configuration may be compared to a second, non-optimized configuration shown in FIG. 9B.

[0529] 9B shows a second configuration in which the antenna 9100 and the tag 9200 are offset from one another by approximately 90 degrees. This second configuration may be less desirable due to a mismatch in the read angles between the antenna 9100 and the tag 9200. 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 mismatch in the read angles. Thus, the magnetic field between the antenna 9100 and the tag 9200 may not be optimized in this second configuration. Thus, the read distance between the antenna 9100 and the tag 9200 is reduced in this configuration compared to the configuration of FIG. 9A.

[0530] Therefore, 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 directly proportional to the angle at which the antenna 9100 and the tag 9200 are oriented relative to one another. For example, as shown in Figure 9A, the magnetic field between the antenna 9100 and the tag 9200 may be optimized when the angle between the antenna 9100 and the tag 9200 is small. The magnetic field between the antenna 9100 and the tag 9200 may decrease as the antenna 9100 and / or the tag 9200 are angled relative to one another, as shown in Figure 9B.

[0531] 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 several factors. For example, if the antenna 9100 is incorporated into the air circuit 4170, the angle of attachment of the air circuit 4170 relative to the patient interface 3000 can vary greatly depending on the type of patient interface. As shown in FIG. 4P and described above, numerous patient interface configurations are possible. Furthermore, the location where the tag 9200 is incorporated into the patient interface 3000 can also affect the relative orientation of the tag 9200 and antenna 9100 when the air circuit 4170 is coupled to the patient interface 3000.

[0532] The multi-directional antenna configurations shown in Figures 9C and 9D may be configured to compensate for differences in mounting angles between the air circuit 4170 and the patient interface 3000, facilitating reading at a wider range of angles and mitigating one or more of the effects on read distance described above with reference to Figure 9B. The disclosed multi-angle antenna configurations may be designed to arrange multiple antennas in a three-dimensional shape to create efficient read orientations between the antenna 9100 and tag 9200 across a variety of different patient interface types.

[0533] In the configuration shown in FIG. 9C , the two antennas 9100A and 9100B may be oriented at an angle to each other such that the first antenna 9100A and the second antenna 9100B point in different directions. Thus, the first antenna 9100A and the second antenna 9100B are configured to provide a read angle in two directions. The orientation of the tag 9200 in FIG. 9C may represent the position 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 represent the position of the first antenna 9100A and the second antenna 9100B on the air circuit 4170 when attached to a patient interface or accessory. In the configuration shown in FIG. 9C , the relative orientation of the first antenna 9100A and the second antenna 9100B may resemble “FIG. 8” to provide a read angle in two directions. For example, the first antenna 9100A is configured to provide a first read angle in a first direction, and the second antenna 9100B is configured to provide a second read angle in a second direction. The read directions for the tag 9200 are indicated by the arrows shown in FIG. 9C . In this manner, the tag 9200 may be efficiently read from multiple directions. For example, the tag 9200 may be read by the first antenna 9100A or the second antenna 9100B depending on where the tag 9200 is positioned relative to the first antenna 9100A and the second antenna 9100B. In the arrangement of FIG. 9C , the tag 9200 may be read by the first antenna 9100A because the first antenna 9100A may be the antenna with the read angle more directly oriented relative to the tag 9200.

[0534] The first antenna 9100A and the second antenna 9100B may be offset from one another by an angle A. The angle A may be approximately 90 degrees. Alternatively, the angle A may be greater than 90 degrees or less than 90 degrees. For example, the angle A may be between approximately 30 degrees and approximately 120 degrees, or any other suitable angle.

[0535] 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 between the reader and the tag, as well as the communication distance, may also be increased. Although a frequency of 13.56 MHz is used as an example, as mentioned above, any other suitable frequency may be utilized.

[0536] FIG. 9D shows another multi-directional antenna arrangement that may include additional antennas with more complex three-dimensional shapes. In this configuration, a first antenna 9100A, a second antenna 9100B, a third antenna 9100C, a fourth antenna 9100D, and a fifth antenna 9100E are oriented to provide multi-directional read angles. The orientation of the tag 9200 in FIG. 9D may represent the location of the tag 9200 on a patient interface or accessory, and the orientations of the antennas 9100A-9100E may represent the location of the antennas 9100A-9100E on the air circuit 4170 when attached to a patient interface or accessory. While five antennas are shown, more antennas may be used to increase the number of read directions, or fewer antennas may be used to decrease the number of read directions. For example, three, four, six, seven, eight, or more antennas may be used.

[0537] The embodiment of FIG. 9D may be compatible 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 tag 9200. Additionally, in some aspects, as described above, the air circuit 4170 may be configured to move or swivel relative to the patient interface 3000 when connected to the patient interface 3000. For example, the air circuit 4170 may have a swivel or a patient interface connector. The antenna arrangement of FIG. 9D incorporates multiple antennas oriented to point in multiple different directions, so that as the air circuit 4170 moves relative to the patient interface when connected to the patient interface, portions of the multi-directional antenna radiation field may be received by the tag 9200. As the air circuit 4170 moves, different antennas in the multi-directional configuration may be used to read the tag 9200 depending on which antenna is most closely aligned with the tag 9200.

[0538] In some cases, the first antenna 9100A, the second antenna 9100B, the third antenna 9100C, the fourth antenna 9100D, and the fifth antenna 9100E 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 between the reader and the tag, as well as the communication distance, may also be increased. Although a frequency of 13.56 MHz is used as an example, as mentioned above, any other suitable frequency may be utilized.

[0539] 10A-10D show various configurations between various patient interfaces and the air circuit. The antenna and tag configurations shown in Figures 9C-9D may be utilized, for example, to create efficient read orientations in the configurations shown in Figures 10A-10D.

[0540] For example, FIG. 10A shows a frame 10000 of a tube-up nasal patient interface. In some embodiments, the frame 10000 may be used in conjunction with the patient interface 3000 shown in FIGS. 8A and 8B. The frame 10000 is configured such that the air circuit 4170 is coupled to the frame 10000 at or near the top of the user's head, for example, via a joint 10002. The air circuit 4170 may be rotatably coupled to the frame 10000 via the joint 10002. The joint 10002 may be a swivel joint, thus facilitating rotation of the air circuit 4170 relative to the frame 10000. As shown, the frame 10000 and the air circuit 4170 are angled relative to one another at approximately a 90-degree angle. Thus, the antenna 9100 secured in or on the proximal portion of the air circuit 4170 may be angled relative to the tag 9200 secured in or on the frame 10000.

[0541] As discussed above, the orientation of the antenna 9100 and tag 9200 can affect the antenna 9100's ability to read the tag 9200. Thus, in the configuration shown in FIG. 10A , using a single two-dimensional antenna 9100 as shown can reduce read efficiency between the antenna 9100 and the tag 9200. Using two or more antennas 9100 in the form of a multi-dimensional antenna, for example, as shown in FIGS. 9C and 9D , can reduce read efficiency between the antenna 9100 and the tag 9200 in this configuration. For example, as shown in FIG. 9D , a first antenna 9100A, a second antenna 9100B, a third antenna 9100C, a fourth antenna 9100D, and / or a fifth antenna 9100E may be utilized in this configuration. The use of multiple antennas arranged in a three-dimensional configuration can facilitate efficient reading of the tag 9200 regardless of the orientation of the air circuit 4170 relative to the frame 10000 when connected.

[0542] FIG. 10B illustrates an alternative configuration between the patient interface 3000 and the air circuit 4170, such as a tube-down nasal patient interface (according to any of the examples described herein). The air circuit 4170 may be coupled to the patient interface via a joint 11000. The joint 11000 may facilitate rotation of the air circuit 4170, for example, about axis X. Depending on the manner of relative movement of the air circuit 4170 and the patient interface 3000, use of a single two-dimensional antenna 9100 as shown may result in reduced read efficiency in some relative configurations. For example, using two or more antennas 9100 in the form of a multi-dimensional antenna, as shown in FIGS. 9C and 9D, may improve read efficiency between the antenna 9100 and the tag 9200. For example, as shown in FIG. 9D, a first antenna 9100A, a second antenna 9100B, a third antenna 9100C, a fourth antenna 9100D, and / or a fifth antenna 9100E may be utilized 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.

[0543] 10C and 10D show another alternative configuration between the patient interface 3000 and the air circuit 4170. For example, in this configuration, the patient interface 3000 is a tube-down full-face patient interface. The air circuit 4170 may be coupled to the patient interface via a joint 12000. The joint 12000 may be a pivotal joint, thus facilitating rotation of the air circuit 4170. For example, the joint 12000 may facilitate rotation of the patient interface 3000 about axis Y as well as translation of the air circuit 4170 relative to the patient interface 3000. FIGS. 10C and 10D show different positions of the air circuit relative to the patient interface 3000 and the tag 9200, for example, depending on different positions the patient may assume while wearing the patient interface 3000. As the patient moves during use, the air circuit 4170 may change orientation unpredictably. In the positions shown in FIGS. 10C and 10D, the antenna 9100 and the tag 9200 may be offset from each other. For example, the antenna 9100 and the tag 9200 may be oriented such that the antenna 9100 and the tag 9200 are at an angle relative to one another. As previously mentioned, an angle between the antenna 9100 and the tag 9200 can lead to a sub-optimal read orientation. As discussed above with reference to FIGS. 10A and 10B, the use of two or more antennas 9100, for example in the form of a multi-dimensional antenna as shown in FIGS. 9C and 9D, may improve read efficiency between the antenna 9100 and the tag 9200. For example, as shown in FIG. 9D, a first antenna 9100A, a second antenna 9100B, a third antenna 9100C, a fourth antenna 9100D, and / or a fifth antenna 9100E may be utilized 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.

[0544] Each embodiment discussed herein may allow a user to detect the identity of the patient interface or accessory being used. In that way, information about the patient interface, accessory, patient, or prescribed treatment may be transmitted via RFID. Each embodiment may help improve patient use and / or patient comfort, among other things.

[0545] It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed apparatus without departing from the scope of the present disclosure. Other embodiments of the present disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with the true scope and spirit of the invention being indicated by the following claims.

[0546] [Table 4] TIFF2026500998000006.tif254170 TIFF2026500998000007.tif254170 TIFF2026500998000008.tif254170 TIFF2026500998000009.tif254170 TIFF2026500998000010.tif75170

Claims

1. 1. An air adapter tube for diagnosing and / or treating a respiratory disorder, comprising: a tubular body configured to transport pressurized therapeutic air between a proximal end of the tubular body and a distal end of the tubular body, the proximal end configured to connect to a patient interface and the distal end configured to connect to an air delivery tube; a sensor configured to generate a signal for diagnosing and / or treating a respiratory disorder based on air passing through the proximal end.

2. 1. An air adapter tube for diagnosing and / or treating a respiratory disorder, comprising: a tubular body configured to transport pressurized therapeutic air between a proximal end of the tubular body and a distal end of the tubular body, the proximal end configured to connect to a patient interface and the distal end configured to connect to an air delivery tube; a sensor configured to generate a signal indicative of a patient's sleeping position.

3. 1. An air adapter tube for diagnosing and / or treating a respiratory disorder, comprising: a tubular body configured to transport pressurized therapeutic air between a proximal end of the tubular body and a distal end of the tubular body, the proximal end configured to connect to a patient interface and the distal end configured to connect to an air delivery tube; a sensor configured to generate a signal indicative of exhaled breath and / or biomarkers of gases exhaled by the patient.

4. 1. An air adapter tube for diagnosing and / or treating a respiratory disorder, comprising: a proximal end and a distal end, the proximal end configured to releasably couple to a patient interface and the distal end configured to releasably couple to an air delivery tube; a sensor configured to generate a signal based on a sensed physical quantity; an antenna configured to receive data from an RFID tag.

5. The air adapter tube of claim 1 , wherein the sensor comprises a pressure sensor.

6. The air adapter tube of claim 2 or 4, wherein the sensor includes an accelerometer.

7. The sensor is ２ 5. An air adapter tube according to any one of claims 3 and 4, including a sensor.

8. The CO ２ The sensor is ２ Accumulation, rebreathing CO ２ 8. The air adapter tube of claim 7, configured to detect level and / or breathing comfort.

9. The CO ２ 9. An air adapter tube according to any of claims 7 to 8, wherein a sensor is configured to be positioned between the patient and a ventilation opening of the patient interface.

10. The CO ２ The sensor measures end-tidal CO ２ 10. An air adapter tube according to any one of claims 7 to 9, configured to detect

11. 11. The air adapter tube of claim 5, wherein the sensor is a volatile organic compound (VOC) sensor configured to detect biomarkers in the patient's exhaled breath.

12. The sensor ２ a sensor or a volatile organic compound (VOC) sensor, The CO ２ 12. The air adapter tube of claim 11, wherein the sensor and / or the VOC sensor is configured to perform a pre-treatment analysis before pressurized therapeutic air is supplied to the patient interface.

13. 13. An air adapter tube according to any one of claims 1 to 12, wherein the tubular body comprises a flexible material.

14. An air adapter tube according to any one of claims 1 to 13, wherein the inner diameter of the tubular body is about 10 to 15 mm.

15. 15. The air adapter tube of claim 14, wherein the inner diameter of the tubular body is 12 mm.

16. An air adapter tube according to any one of claims 1 to 15, wherein the tubular body has a length of about 8.5 to 10 cm.

17. 17. The air adapter tube of claim 16, wherein the length is approximately 8.5 cm.

18. 18. An air adapter tube according to any one of claims 1 to 17, wherein the outer surface of the tubular body comprises or is covered with a woven material.

19. 19. An air adapter tube according to any one of claims 1 to 18, wherein the tubular body comprises a helix.

20. 20. The air adapter tube of any one of claims 1 to 19, wherein the proximal end includes a mechanical connector configured to connect to the patient interface.

21. 21. The air adapter tube of claim 20, wherein the mechanical connector comprises a circlip having a pair of opposing clips configured to connect to a patient interface.

22. 21. The air adapter tube of claim 20, wherein the mechanical connector includes an isotaper configured to connect with the patient interface in an interference fit or a friction fit.

23. 23. An air adapter tube according to any one of claims 1 to 22, further comprising a flexible printed circuit at the proximal end supporting the sensor.

24. 24. The air adapter tube of any one of claims 1 to 3 and 5 to 23, further comprising an antenna.

25. 25. The air adapter tube of any one of claims 4 to 24, wherein the antenna is configured to wirelessly transmit collected sensor data to an external device including a smartphone or a flow generator.

26. 26. The air adapter tube of any one of claims 4, 24 and 25, further comprising at least one wire connection point connecting said antenna to at least one wire extending along and from said tubular body.

27. 27. An air adapter tube according to any one of claims 23 to 26, wherein the flexible printed circuit includes straight sections supporting electronic components and at least one flexible bend between the straight sections.

28. 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 acceleration sensor configured to generate a signal indicative of the patient's sleeping position.

29. 29. The air adapter tube of claim 27, wherein the electronic component includes one or more sensors configured to generate a signal indicative of exhaled breath and / or a biomarker indicative of patient health.

30. The one or more sensors ２ 30. The air adapter tube of claim 29, including a sensor or a volatile organic compound (VOC) sensor.

31. 31. The air adapter tube of any one of claims 1 to 30, further comprising a temperature sensor configured to generate a signal indicative of a temperature within the tubular body.

32. 32. An air adapter tube according to any one of claims 1 to 31, further comprising a first adapter element at the proximal end, the first adapter element supporting the sensor.

33. 33. The air adapter tube of claim 32, wherein the first adapter element includes a ported outer cylindrical surface, and the sensor projects radially inward into and / or through the port.

34. 34. The air adapter tube of claim 33, further comprising silicone for sealing the port adjacent the sensor.

35. 35. An air adapter tube according to any one of claims 32 to 34, further comprising a second adapter element that connects and seals with the film and helix of the tubular body.

36. 36. An air adapter tube according to any one of claims 32 to 35, further comprising a cuff portion connected to the first adapter element, the first adapter element and the cuff portion forming an annular space configured to receive a flexible printed circuit supporting the sensor.

37. 37. An air adapter tube as described in any one of claims 32 to 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. 38. An air adapter tube according to any one of claims 32 to 37, further comprising ventilation openings along the periphery of the first adapter element.

39. 39. The air adapter tube of claim 38, further comprising a water-resistant pressure balance membrane disposed in the vent and configured to regulate a differential pressure at the proximal end.

40. 40. The air adapter tube of any one of claims 1 to 39, further comprising an electrical connector provided at the distal end of the tubular body, the electrical connector configured to electrically connect to a corresponding electrical connector on a heated air delivery tube.

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

42. 42. An air adapter tube according to any one of claims 40 to 41, further comprising an indicator or guide adjacent the distal end configured to align with a corresponding indicator or guide on the heated air delivery tube.

43. 43. An air adapter tube according to any one of claims 40 to 42, further comprising at least one wire extending along the tubular body and electrically connecting the electrical connector to the sensor and / or flexible printed circuit.

44. 44. An air adapter tube as described in any one of claims 40 to 43, further comprising a mechanical connector provided at the distal end of the tubular body, the mechanical connector configured to mechanically connect to a corresponding mechanical connector on the heated air delivery tube.

45. 45. An air adapter tube according to any preceding claim, further comprising a power source configured to provide power to the sensor and / or flexible printed circuit.

46. The sensor a plurality of sensors including at least a 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 the patient's sleeping position; 46. ​​The air adapter tube of any one of claims 1 to 45, wherein the third sensor is configured to generate a signal indicative of the exhaled breath and / or biomarkers of gas exhaled by the patient before treatment is administered.

47. The air supply tube a first electrical connection configured to couple to a first wire configured to supply electrical power; 47. An air adapter tube according to any one of claims 1 to 46, further comprising: a second electrical connection configured to couple to a second wire configured to transmit and receive data to and from the air delivery tube.

48. 25. An air adapter tube as claimed in any of claims 4 and 24, wherein the antenna is a multi-directional antenna with multiple antennas oriented at different angles to each other.

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

50. 50. An air adapter tube as described in any of claims 48 and 49, wherein the plurality of antennas includes at least a first antenna and a second antenna, the first antenna and the second antenna being oriented at an angle of from about 30 degrees to about 120 degrees from each other.

51. 51. An air adapter tube according to any one of claims 48 to 50, wherein the plurality of antennas are tuned to a frequency between about 10 MHz and about 12 GHz.

52. 52. An air adapter tube according to any one of claims 1 to 51, wherein the sensor is supported at the proximal end.

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

54. 54. The medical instrument of claim 53, wherein the flow generator is configured to be controlled based on an output from the sensor.

55. 1. A method for diagnosing and / or treating a patient, comprising: connecting an air adapter tube according to any one of claims 1 to 52 between an air delivery tube and a patient interface; generating a signal with the sensor; transmitting the signal for use in diagnosing or treating the patient.

56. 1. A system comprising: an air adapter tube according to any one of claims 1 to 52; at least one hardware processor, the hardware processor configured to perform operations including controlling when the sensor is configured to sense a physical quantity.

57. 57. The system of claim 56, wherein the sensor is controlled based on a determined position of the patient.

58. 58. A system as claimed in any of claims 56 and 57, wherein the sensor is controlled to sense the physical quantity before positive air pressure is supplied to the air adapter tube.

59. 59. A system according to any one of claims 56 to 58, wherein the sensor is controlled to sense the physical quantity based on a determination that positive air pressure is not supplied to the air adapter tube.

60. 1. A system comprising: an air adapter tube according to any one of claims 1 to 52; at least one hardware processor configured to perform operations including altering at least one treatment parameter based on the generated signal of the sensor.

61. 61. The system of any one of claims 56 to 60, further comprising a patient interface including an RFID tag containing data received by the antenna of the air adapter tube.

62. 1. A system comprising: an air adapter tube according to 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 pressure data obtained from a pressure sensor in the air adapter tube.

63. 1. A system comprising: an air adapter tube according to any one of claims 1 to 52; CO of the air adapter tube ２ and at least one hardware processor configured to perform operations including causing the flow generator to adjust the generated pressure based on data obtained from the sensor.

64. 53. The air adapter tube of any one of claims 1 to 52, further comprising a controller electrically coupled to the sensor.

65. 65. The air adapter tube of claim 64, wherein the controller includes a hardware processor and non-transitory memory.

66. 66. The air adapter tube of claim 65, wherein data obtained from the sensor is stored in the non-transitory memory.

67. 67. The air adapter tube of any one of claims 1-52 and 63-66, further comprising a radio transceiver electrically coupled to the antenna.

68. 68. The air adapter tube of any one of claims 1-52 and 63-67, further comprising a second transceiver configured to transmit and receive data to and from the flow generator.

69. 69. The air adapter tube of claim 68, wherein the second transceiver is a wired transceiver.

70. 69. An air adapter tube according to claim 68, 69. The air adapter tube of claim 68, comprising a power management system, wherein the second transceiver is electrically coupled to a power source external to the air adapter tube and further configured to supply power from the power source to the power management system.

71. 1. An air adapter tube for diagnosing and / or treating a respiratory disorder, comprising: a proximal end and a distal end, the proximal end configured to releasably couple to a patient interface and the distal end configured to releasably couple to an air delivery tube; a sensor configured to generate a signal based on a sensed physical quantity; an antenna configured to receive data from an RFID tag; the air adapter tube comprising: a controller electrically coupled to the sensor and the wireless transceiver.

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

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

74. 73. The air adapter tube of claim 72, wherein the second transceiver wirelessly transmits the sensor data to another device.

Images