Devices, systems, and methods for detecting medical devices

Abstract

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

Description

[0001] Cross - reference to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 387,325, filed on December 14, 2022, 63 / 487,311, filed on February 28, 2023, 63 / 487,317, filed on February 28, 2023, and 63 / 515,681, filed on July 26, 2023, each of which is hereby incorporated by reference in its entirety. 2 Background Art 2.1 Technical Field

[0004] This technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and ameliorating respiratory - related disorders. This technology also relates to medical devices or apparatuses and their uses.

[0005] 2.2 Related Art Description

[0006] 2.2.1 The Human Respiratory System and Its Disorders

[0007] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0008] The airway includes a series of branching tubes that become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from the inhaled air into the venous blood while carbon dioxide moves in the opposite direction. The trachea divides into the right and left main bronchi, which ultimately divide further into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further branching of the airway leads to respiratory bronchioles and ultimately to alveoli. The alveolar region of the lungs is where gas exchange occurs and is referred to as the respiratory zone. See "Respiratory Physiology", 9th Edition, published by John B. West, Lippincott Williams & Wilkins in 2012.

[0009] There is a series of respiratory disorders. Some disorders can be characterized by specific events, such as apnea, hypopnea, and hyperventilation.

[0010] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne - Stokes respiration (CSR), respiratory insufficiency, obesity - hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0011] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events that include upper airway occlusion or obstruction during sleep. It is caused by a combination of an abnormally small upper airway during sleep and the normal loss of muscle tone in the regions of the tongue, soft palate, and posterior oropharyngeal wall. This condition causes affected patients to stop breathing, typically for periods of 30 seconds to 120 seconds, sometimes 200 to 300 times per night. This often results in excessive daytime sleepiness, and it can lead to cardiovascular disease and brain damage. The syndrome is a common disorder, particularly common in middle-aged overweight men, but affected individuals may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0012] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of a patient's respiratory control system in which there are rhythmic alternating cycles of increasing and decreasing ventilation, known as CSR cycles. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to the repeated hypoxia, CSR has the potential to be harmful. In some patients, CSR is associated with repeated awakenings from sleep, which can result in severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] Respiratory failure is a general term for disorders of the respiratory system in which the lungs are unable to inhale sufficient oxygen or exhale sufficient CO2 to meet the patient's needs. Respiratory failure can encompass some or all of the following disorders.

[0014] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0015] Obesity hypoventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia while awake, in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0016] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain characteristics. These symptoms include increased resistance to air flow, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (the major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: dyspnea on exertion, chronic cough, and sputum production.

[0017] Neuromuscular diseases (NMDs) is a broad term that encompasses many diseases and afflictions that directly or indirectly impair muscle function via intrinsic muscle pathology or neuropathology, respectively. Some NMD patients are characterized by progressive muscle damage that leads to loss of the ability to walk, wheelchair dependence, difficulty swallowing, weakening of the respiratory muscles, and ultimately death from respiratory failure. Neuromuscular diseases can be classified as rapidly progressive and slowly progressive: (i) rapidly progressive diseases: characterized by muscle damage that worsens within months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive conditions: characterized by muscle damage that worsens over years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral muscular dystrophy, and myotonic dystrophy). Symptoms of respiratory failure in NMDs include: increasing general fatigue, difficulty swallowing, dyspnea on exertion and at rest, exhaustion, drowsiness, morning headaches, and difficulty concentrating and mood changes.

[0018] Thoracic wall disorders are a group of chest deformities that result in an inefficient coupling between the respiratory muscles and the thoracic cage. These disorders are typically characterized by restrictive defects and have the potential for chronic hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, morning headaches, exhaustion, poor sleep quality, and loss of appetite.

[0019] A range of therapies have been used to treat or improve such conditions. In addition, other healthy individuals can utilize such therapies to prevent the onset of respiratory disorders. However, these therapies have many drawbacks.

[0020] 2.2.2 Therapies

[0021] Various respiratory therapies, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT) have been used to treat one or more of the above respiratory disorders.

[0022] 2.2.2.1 Respiratory pressure therapy

[0023] Respiratory pressure therapy is the application of air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapies such as tank ventilators or cuirass ventilators).

[0024] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). Its mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway obstruction, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy can be voluntary, and thus, if patients find that the device used to provide such therapy has one or more of the following conditions, they may choose not to comply with the therapy: uncomfortable, difficult to use, expensive, and unaesthetic.

[0025] Non-invasive ventilation (NIV) provides ventilation support to a patient through the upper airway to assist the patient in breathing and / or to maintain an appropriate oxygen level in the body by completing some or all of the work of breathing. The ventilation support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, which occur in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0026] Invasive ventilation (IV) provides ventilation support to patients who are no longer able to breathe effectively on their own and can be provided using a tracheostomy tube or an endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0027] 2.2.2.2 Flow therapy

[0028] Not all respiratory therapies are aimed at delivering a prescribed therapeutic pressure. Some respiratory therapies are aimed at delivering a prescribed respiratory volume by delivering an inspiratory flow rate curve (possibly superimposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and the respiratory therapy can only supplement the patient's own spontaneous breathing with a regulated or enriched gas flow. In one example, high flow therapy (HFT) can provide a continuous, heated, humidified air flow to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that remains substantially constant throughout the respiratory cycle. This therapeutic flow is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow of air at the airway inlet improves ventilation efficiency by flushing or washing out exhaled CO2 from the patient's anatomic dead space. Thus, HFT is sometimes referred to as deadspace therapy (DST). Other benefits can include increased warmth and humidity (which may be beneficial in secretion management) and the possibility of a modest elevation in airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate can follow a curve that varies during the respiratory cycle.

[0029] Another form of flow therapy is long - term oxygen therapy (LTOT) or supplementary oxygen therapy. A doctor can prescribe a continuous stream of oxygen - enriched air at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.) and at a specified oxygen concentration (from 21% to 100% of the fraction of oxygen in ambient air) to be delivered to the patient's airway.

[0030] 2.2.2.3 Supplementary Oxygen

[0031] For some patients, oxygen therapy can be combined with respiratory pressure therapy or HFT by adding supplementary oxygen to a pressurized air stream. When oxygen is added to respiratory pressure therapy, this is called RPT with supplementary oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplementary oxygen.

[0032] 2.2.3 Respiratory Therapy Systems

[0033] These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used for screening, diagnosing, or monitoring a condition without treating it.

[0034] A respiratory therapy system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0035] Another form of the therapy system is a mandibular repositioning device.

[0036] 2.2.3.1 Patient Interface

[0037] A patient interface can be used to engage respiratory equipment with its wearer, such as by providing an air stream to the airway inlet. The air stream can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy to be applied, the patient interface can, for example, form a seal with an area of the patient's face to facilitate delivering gas at a pressure with a sufficient difference from the ambient pressure (e.g., at a positive pressure of about 10 cmH2O relative to the ambient pressure) to achieve the therapy. For other forms of therapy, such as delivering oxygen, the patient interface may not include a seal sufficient to facilitate delivering a gas supply to the airway at a positive pressure of about 10 cmH2O. For flow therapies such as nasal HFT, the patient interface is configured to blow air into the nostrils but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0038] Some other mask systems may not be functionally applicable in this field. For example, a purely decorative mask may not be able to maintain an appropriate pressure. A mask system for underwater swimming or diving can be constructed to prevent the entry of water from an external higher pressure but cannot maintain the internal air at a pressure higher than the ambient pressure.

[0039] Certain face masks may be clinically disadvantageous for the present technology, such as in cases where they block airflow through the nose and only allow airflow through the mouth.

[0040] If certain face masks require the patient to insert a portion of the face mask structure into their mouth to form and maintain a seal through their lips, these face masks may be uncomfortable or impractical for the present technology.

[0041] Certain face masks may not be suitable for use during sleep, such as when sleeping in bed with the head lying on its side on a pillow.

[0042] The design of patient interfaces faces many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary widely among individuals. Since the head includes bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The entire head can move during respiratory therapy.

[0043] Due to these challenges, some face masks suffer from one or more of the problems of being obtrusive, unaesthetic, expensive, ill-fitting, difficult to use, and uncomfortable, especially when worn for long periods or when the patient is unfamiliar with the system. A face mask of the wrong size may lead to reduced compliance, reduced comfort, and a poorer patient prognosis. Face masks designed only for pilots, face masks designed to be part of personal protective equipment (such as filter masks), SCUBA masks, or face masks designed to administer anesthetic agents are acceptable for their original applications, but such face masks may not be as comfortable as desired when worn for long periods (such as several hours). This discomfort may lead to reduced patient compliance with the therapy. This is especially true if the face mask is worn during sleep.

[0044] CPAP therapy is very effective for treating certain respiratory disorders, provided that the patient adheres to the therapy. If the face mask is uncomfortable or difficult to use, the patient may not adhere to the therapy. Since patients are typically advised to clean their face masks regularly, if the face mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean their face mask, which may affect the patient's compliance.

[0045] While face masks for other applications (such as pilots) may not be suitable for treating sleep apnea, face masks designed to treat sleep apnea may be suitable for other applications.

[0046] For these reasons, patient interfaces for delivering CPAP during sleep form a unique field.

[0047] 2.2.3.1.1 Seal-forming structure

[0048] The patient interface may include a seal-forming structure. Since the seal-forming structure is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

[0049] The patient interface may be characterized in part by the design intent of where the seal-forming structure engages the face in use. In one form of the patient interface, the seal-forming structure may include a first sub-part that forms a seal around the left nostril and a second sub-part that forms a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils in use. Such a single element may be designed to cover, for example, the upper lip region and the bridge of the nose of the face. In one form of the patient interface, the seal-forming structure may include an element that surrounds the mouth region in use, such as by forming a seal over the lower lip region of the face. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth region in use. These different types of patient interfaces may be named by their manufacturers by various names, including nasal masks, full face masks, nasal pillows, nasal pillows, and nasal-oral masks.

[0050] For example, due to the different shapes, structures, variabilities, and sensitive areas of the patient's face, a seal-forming structure that may be effective in one area of the patient's face may not be suitable in another area. For example, a seal on a swimming goggle that covers the patient's forehead may not be suitable for use on the patient's nose.

[0051] Certain seal-forming structures may be designed for mass production such that one design fits and is comfortable and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-produced patient interface, one or both must be adapted to form a seal.

[0052] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface, where the seal-forming structure engages the patient's face in a face-to-face manner. The seal-forming structure may include an air- or fluid-filled cushion, or a molded or formed surface of a resilient seal element made of an elastomer such as rubber. For this type of seal-forming structure, if the fit is inadequate, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0053] Another type of seal-forming structure incorporates a flap seal of thin material positioned around the periphery of the face mask to provide a self-sealing action against the patient's face when positive pressure is applied within the face mask. Similar to the previous type of seal-forming portion, if there is a poor fit between the face and the face mask, additional force may be required to achieve a seal, otherwise the face mask may leak. Additionally, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming structure may wrinkle or buckle during use, creating a leak.

[0054] Another type of seal-forming structure may include friction-fit elements, such as for insertion into the nostrils, however some patients find these elements uncomfortable.

[0055] Another form of seal-forming structure may use an adhesive to effect a seal. Some patients may find it inconvenient to apply and remove the adhesive to their face on a regular basis.

[0056] A series of patient interface seal-forming structure techniques are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004310; WO 2006 / 074513; WO 010 / 135785.

[0057] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal prong is the subject of U.S. Patent 4,782,832 (Trimble et al.) assigned to the Puritan-Bennett Corporation.

[0058] ResMed Limited has manufactured the following products incorporating nasal pillows: ResMed Limited has manufactured the following products incorporating nasal pillows: SWIFT TM Nasal Pillow Mask, SWIFT TM II Nasal Pillow Mask, SWIFT TM LT Nasal Pillow Mask, SWIFT TM FX Nasal Pillow Mask and MIRAGE LIBERTY TMFull face mask. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: International Patent Application WO2004 / 073,778 (which describes aspects of the ResMed Limited SWIFT™ nasal pillow), U.S. Patent Application 2009 / 0044808 (which describes other aspects of the ResMed Limited SWIFT™ LT nasal pillow); International Patent Applications WO2005 / 063,328 and WO 2006 / 130,903 (which describe aspects of the ResMed Limited MIRAGE LIBERTY™ full face mask); International Patent Application WO 2009 / 052,560 (which describes other aspects of the ResMed Limited SWIFT™ FX nasal pillow).

[0059] 2.2.3.1.2 Positioning and stabilization

[0060] The seal-forming structure of a patient interface for positive pressure therapy is subject to a corresponding force from the air pressure that would break the seal. Accordingly, various techniques have been used to position the seal-forming structure and maintain its sealed relationship with the appropriate portion of the face.

[0061] One technique is to use an adhesive. See, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

[0062] Another technique is to use one or more straps and / or stabilizing straps. Many such straps have one or more problems of ill-fitting, bulky, uncomfortable, and inconvenient to use.

[0063] 2.2.3.2 Respiratory pressure therapy (RPT) device

[0064] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to deliver one or more of the above-described various therapies, such as by operating the device to generate an air stream for delivery to an airway interface. The air stream can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Accordingly, an RPT device can also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0065] Air pressure generators are known within the scope of applications such as industrial-scale ventilation systems. However, air pressure generators for medical applications have special requirements that cannot be met by more general air pressure generators, such as the reliability, size, and weight requirements of medical devices. Additionally, even devices designed for medical use can have drawbacks regarding one or more of the following: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.

[0066] An example of a special requirement for some RPT devices is acoustic noise.

[0067] Table of noise output levels of existing RPT devices (only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0068] Name of RPT device A-weighted sound pressure level dB(A) Year (approx.) Series C TangoTM 31.9 2007 Series C TangoTM with humidifier 33.1 2007 S8 EscapeTMII 30.5 2005 S8 EscapeTMII with H4iTM humidifier 31.1 2005 S9 AutoSetTM 26.5 2010 S9 AutoSetTM with H5i humidifier 28.6 2010

[0069] A known RPT device for treating sleep apnea is the S9 sleep therapy system manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators, such as the ResMed Stellar TM series, can provide invasive and non-invasive non-dependent ventilation support for a range of patients to treat a variety of conditions, such as but not limited to NMD, OHS, and COPD.

[0070] ResMed Elisée TM 150 ventilator and ResMed VSIII TM Ventilators can provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients to treat a variety of conditions. These ventilators provide volume ventilation modes and pressure ventilation modes with single-limb or double-limb circuits. RPT devices generally include a pressure generator, such as an electric motor-driven blower or a compressed gas reservoir, and are configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0071] There can be an infinite number of choices available to the designer of the device. Design criteria often conflict, meaning that certain design choices are outside the norm or inevitable. Additionally, comfort and efficacy in certain aspects can be highly sensitive to small and subtle changes in one or more parameters.

[0072] 2.2.3.3 Air circuit

[0073] An air circuit is a conduit or tube that is constructed and arranged to allow airflow to travel between two components of a respiratory therapy system, such as an RPT device and a patient interface, in use. In some cases, there may be separate branches for the air circuits for inhalation and exhalation. In other cases, a single branch air circuit is used for both inhalation and exhalation.

[0074] 2.2.3.4 Humidifier

[0075] Delivering an unhumidified airflow can cause airway dryness. A humidifier with an RPT device and a patient interface is used to produce humidified gas, thus minimizing dryness of the nasal mucosa and increasing patient airway comfort. Additionally, in colder climates, warm air that is typically applied to the facial area inside and around the patient interface is more comfortable than cold air.

[0076] A series of artificial humidifying devices and systems are known, however they do not meet the special requirements of medical humidifiers.

[0077] When needed, a medical humidifier is used to increase the humidity and / or temperature of an airflow relative to ambient air, typically when the patient is asleep or resting (e.g., in a hospital). A medical humidifier placed at the bedside can be small. A medical humidifier can be constructed to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (such as saunas, air conditioners, evaporative coolers, etc.) can also humidify the air inhaled by the patient, however these systems also humidify and / or heat the entire room, which may make the occupants uncomfortable. Additionally, medical humidifiers can have more stringent safety constraints than industrial humidifiers.

[0078] Although many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide inadequate humidification, and some are difficult or inconvenient for patients to use.

[0079] 2.2.3.5 Oxygen source

[0080] Experts in the field have recognized that exercise can bring long-term benefits to patients with respiratory failure, slowing the progression of the disease, improving quality of life, and extending the patient's lifespan. However, most fixed 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 achieved by using small compressed oxygen cylinders or oxygen bottles mounted on carts with casters. The drawback of these oxygen cylinders is that they contain a limited amount of oxygen and are heavy, weighing approximately 50 pounds when mounted.

[0081] Oxygen concentrators have been used for approximately 50 years to supply oxygen for respiratory therapy. Traditional oxygen concentrators are large and bulky, making it difficult and impractical to use them for ordinary walking activities. Recently, companies that manufacture large stationary oxygen concentrators have begun to develop portable oxygen concentrators (POCs). The advantage of POCs is that they can produce a theoretically unlimited supply of oxygen. To make these devices small and portable, the various systems required to produce oxygen-rich gas are compressed. POCs seek to use the oxygen they produce as efficiently as possible to minimize weight, size, and power consumption. This can be achieved by delivering oxygen in the form of a series of pulses, each pulse or "bolus" timed to coincide with the start of inhalation. This therapy mode is called pulsed oxygen delivery (POD) or demand mode, as opposed to the traditional continuous flow delivery that is more suitable for stationary oxygen concentrators.

[0082] 2.2.3.6 Data Management

[0083] There may be clinical reasons for obtaining data to determine whether a patient receiving respiratory therapy is "compliant", such as if the patient has used their RPT device according to one or more "compliance rules". An example of a compliance rule for CPAP therapy is that a patient needs to use their RPT device for at least four hours each night for 21 days out of 30 consecutive days to be considered compliant. To determine a patient's compliance, a provider of an RPT device, such as a healthcare provider, can manually obtain data describing the patient's therapy using the RPT device, calculate the usage over a predetermined period, and compare it to the compliance rule. Once the healthcare provider has determined that the patient has used their RPT device according to the compliance rule, the healthcare provider can inform the patient of the third part of the compliance.

[0084] Transmitting therapy data to a third party or external system may be beneficial for other aspects of a patient's therapy.

[0085] Existing methods of communicating and managing such data can be one or more of the following: expensive, time-consuming, and error-prone.

[0086] 2.2.3.7 Ventilation Techniques

[0087] Some forms of treatment systems can include ventilation to allow for the flushing of exhaled carbon dioxide. Ventilation can allow gas to flow from the internal space of the patient interface (e.g., a pneumatic chamber) to the external space of the patient interface, such as to the environment.

[0088] Ventilation can include an orifice and gas can flow through the orifice in the use of a mask. Many such ventilations are very noisy. Others may become blocked during use, providing inadequate flushing. Some ventilations can, for example, interfere with the sleep of a patient 1000's bed partner 1100 through noise or a turbulent airflow.

[0089] ResMed Limited has developed a number of improved mask ventilation techniques. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0090] Noise table of existing masks (ISO 17510-2:2007, pressure of 10 cmH2O at 1 m)

[0091]

[0092] (*Only one sample, measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744)

[0093] The sound pressure values of various objects are listed below

[0094]

[0095] 2.2.4 Screening, diagnosis and monitoring systems

[0096] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiorespiratory disorders and usually involves clinical experts to apply the system. PSG typically includes placing 15 to 20 contact sensors on the patient to record various body signals such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep disordered breathing includes observing the patient for two nights in the clinic, one night for pure diagnosis and a second night for the clinician to titrate treatment parameters. Therefore, PSG is both expensive and inconvenient. In particular, it is not suitable for screening / diagnosing / monitoring sleep disordered breathing at home.

[0097] Screening and diagnosis generally describe identifying a disorder from the signs and symptoms of the disorder. Screening usually gives true / false results indicating whether the patient's SDB is severe enough to require further examination, while diagnosis may produce clinically actionable information. Screening and diagnosis are often one-time processes, while monitoring of the progression of the disorder can continue indefinitely. Some screening / diagnosis systems are only suitable for screening / diagnosis, while some can also be used for monitoring.

[0098] Clinical experts may be able to adequately screen, diagnose or monitor patients based on visually observed PSG signals. However, there are situations where clinical experts may not be available or may not be affordable. Different clinical experts may have different opinions on the patient's disorder. In addition, a given clinical expert may apply different criteria at different times. 3 Summary of the Invention

[0099] The present technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, which have one or more of improved comfort, cost, efficacy, ease of use, and manufacturability.

[0100] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0101] Another aspect of the present technology relates to a method for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0102] One aspect of certain forms of the present technology is to provide methods and / or devices for improving a patient's compliance with respiratory therapy.

[0103] One form of the present technology includes a positioning and stabilization structure that is configured to provide a force to hold a seal-forming structure in a therapeutically effective position on a patient's head. The positioning and stabilization structure includes at least one strap.

[0104] One form of the present technology includes a patient interface that includes an inflatable chamber, a seal-forming structure, and a positioning and stabilization structure.

[0105] One form of the present technology includes a patient interface that includes an inflatable chamber that can be pressurized to a therapeutic pressure that is at least 4 cmH2O above ambient air pressure. The inflatable chamber includes at least one inflatable chamber inlet port that is sized and configured to receive an air flow at the therapeutic pressure for a patient to breathe. The patient interface further includes a seal-forming structure that is constructed and arranged to form a seal with an area of the patient's face surrounding the patient's airway inlet. The seal-forming structure has holes therein such that the air flow at the therapeutic pressure is delivered at least to the entrances of the patient's nostrils. The seal-forming structure is constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use. The patient interface further includes a positioning and stabilization structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0106] 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.

[0107] In one form, each modular element has at least two versions or styles. These versions or styles can be used interchangeably with each other to form different modular components.

[0108] One form of the present technology includes a respiratory therapy system, comprising: a patient interface; an air circuit configured to be removably coupled to the patient interface; a radio frequency identification (RFID) tag associated with the patient interface, the RFID tag being configured to store information about the patient interface; an antenna; and a transceiver, wherein the transceiver 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.

[0109] In one aspect of the present technology, at least one of the antenna or the transceiver can be located on an adapter configured to couple the air circuit to the patient interface.

[0110] In another aspect, at least one of the antenna or the transceiver is located at the proximal end of the air circuit.

[0111] In one form, at least one of the antenna or the transceiver can be housed within a cap located at the proximal end of the air circuit.

[0112] In one aspect, the RFID tag can 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.

[0113] In various aspects, the controller can be incorporated as part of a respiratory pressure therapy device.

[0114] In one form, the controller can be configured to automatically configure at least one setting of the respiratory pressure therapy device based on the information about the patient interface received from the transceiver.

[0115] In various aspects, the antenna can be a multi-directional antenna including a plurality of antennas oriented at different angles relative to each other.

[0116] In another form, the air circuit for the respiratory therapy system can include: a proximal end and a distal end, wherein the proximal end can be configured to be removably coupled to the patient interface, and the distal end can be configured to be removably coupled to a respiratory pressure therapy device; and a multi-dimensional antenna located at the proximal region of the air circuit, wherein the multi-dimensional antenna can include a plurality of antennas oriented at different angles relative to each other.

[0117] In various aspects, the multi-dimensional antenna can include two antennas.

[0118] In form, the two antennas can be oriented at right angles relative to each other.

[0119] In a further aspect, the multi-dimensional antenna includes three or more antennas.

[0120] In some forms, multiple antennas may include at least a first antenna and a second antenna, where the first antenna and the second antenna may be oriented at an angle of approximately 30 degrees to approximately 120 degrees relative to each other.

[0121] In various aspects, the multiple antennas may be set to a frequency of about 10 MHz to about 12 GHz.

[0122] In another form, a respiratory therapy system may include: a respiratory pressure therapy device; and a controller configured to perform the following operations: receive information about a patient interface from an RFID tag associated with the patient interface; and perform a response action at least in part based on the received information about the patient interface, the response action including configuring one or more of the settings of the respiratory pressure therapy device; generating an indication to recommend a new patient interface or a new patient interface liner; generating an indication to suggest a different size or type of patient interface or liner; generating an indication that the air circuit is not coupled to or not properly coupled to the patient interface; or

[0123] transmit the information about the patient interface to a cloud server.

[0124] In multiple aspects, the controller may be incorporated as part of the respiratory pressure therapy device.

[0125] In form, the received information about the patient interface may include one or more of the following: the type or size of the patient interface; the type or size of the liner; the production lot number or serial number of the patient interface; a timestamp; a usage date; or the length of use of the patient interface.

[0126] In multiple aspects, the information about the patient interface may be received at the start of a treatment session managed by the respiratory therapy system.

[0127] In a further aspect, the information about the patient interface may be received at regular intervals throughout the treatment session managed by the respiratory therapy system.

[0128] In some forms, if an irregularity is detected in the received information, the frequency of receiving the information about the patient interface may increase.

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

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

[0131] Another aspect of one form of the present technology relates to an air adapter tube for diagnosing and / or treating respiratory disorders. The air adapter tube further includes a tubular body configured to deliver pressurized therapeutic air between a proximal end and a distal end of the tubular body, the proximal end being configured to connect to a patient interface and the distal end being configured to connect to an air delivery tube; and a sensor configured to generate a signal indicative of the respiration and / or biomarkers of the patient's exhaled gas.

[0132] Another aspect of one form of the present technology relates to an air adapter tube for diagnosing and / or treating respiratory disorders. The air adapter tube further includes a proximal end and a distal end, wherein the proximal end is configured to removably couple to a patient interface and the distal end is 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.

[0133] In one instance, the sensor includes a pressure sensor.

[0134] In one instance, the sensor includes an accelerometer.

[0135] In one instance, the sensor is a CO2 sensor.

[0136] In one instance, the CO2 sensor is configured to detect CO2 accumulation, rebreathing CO2 levels, and / or respiratory comfort.

[0137] In one instance, the CO2 sensor is configured to be disposed between the patient and ventilation on the patient interface.

[0138] In one instance, the CO2 sensor is configured to detect end-tidal CO2.

[0139] In one instance, the sensor is a volatile organic compound (VOC) sensor configured to detect biomarkers in a patient's breath.

[0140] In one example, the sensor is a CO2 sensor and / or a volatile organic compound (VOC) sensor, and wherein the CO2 sensor and / or (VOC) sensor is configured for pre-treatment analysis before pressurized therapeutic air is delivered to the patient interface.

[0141] In one example, the tubular body comprises a flexible material.

[0142] In one example, the inner diameter of the tubular body is between about 10 - 15 mm.

[0143] In one example, the inner diameter of the tubular body is 12 mm.

[0144] In one example, the length of the tubular body is between about 8.5 - 10 cm.

[0145] In one example, the length is about 8.5 cm.

[0146] In one example, the outer surface of the tubular body comprises or is covered with a textile material.

[0147] In one example, the tubular body comprises a helix.

[0148] In one example, the proximal end comprises a mechanical connector configured to connect to the patient interface.

[0149] In one example, the mechanical connector comprises an open coil spring having a pair of opposing clips configured to be connected to the patient interface.

[0150] In one example, the mechanical connector comprises an isoconical body configured to connect to the patient interface by an interference fit or a friction fit.

[0151] In one example, the air adapter tube further comprises a flexible printed circuit that supports the sensor at the proximal end.

[0152] In one example, the flexible circuit comprises an antenna, which may be an NFC antenna.

[0153] In one example, the antenna is configured to wirelessly transmit the collected sensor data to an external device including a smart phone or a flow generator.

[0154] In one example, the flexible printed circuit comprises at least one wire connection point that connects the antenna to at least one wire that extends along and from the tubular body.

[0155] In one example, the flexible printed circuit comprises a linear portion that supports electronic components and at least one flexible bending portion between the linear portions.

[0156] In one instance, one of the electronic components is a pressure sensor and the other of the electronic components is an accelerometer sensor configured to generate a signal indicative of a patient's sleep position.

[0157] In one instance, the electronic components include one or more sensors configured to generate a signal representative of respiration and / or a biomarker indicative of a patient's health.

[0158] In one instance, the one or more sensors include a CO2 sensor or a volatile organic compound (VOC) sensor.

[0159] In one instance, the air adapter tube further includes a temperature sensor configured to produce a signal representative of the temperature within the tubular body.

[0160] In one instance, the air adapter tube further includes a first adapter element at the proximal end that supports the sensor.

[0161] In one instance, the first adapter element includes an outer cylindrical surface having a port, and the sensor projects radially inwardly into and / or through the port.

[0162] In one instance, the air adapter tube further includes silicone to seal the port adjacent to the sensor.

[0163] In one instance, the air adapter tube further includes a second adapter element that connects and seals to the membrane and helix of the tubular body.

[0164] In one instance, the air adapter tube further includes a ferrule portion connected to the first adapter element, and the first adapter element and the ferrule portion form an annular space configured to receive a flexible printed circuit that supports the sensor.

[0165] In one instance, 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.

[0166] In one instance, the air adapter tube further includes vent holes along the perimeter of the first adapter element.

[0167] In one instance, the air adapter tube further includes a waterproof pressure equalizing membrane provided to the vent holes and configured to regulate the differential pressure at the proximal end.

[0168] In one instance, the air adapter tube further includes an electrical connector provided at the distal end of the tubular body, the electrical connector configured to electrically connect to a corresponding electrical connector of a hot air delivery tube.

[0169] In one example, the electrical connector includes a lead frame configured to transmit power and / or signals.

[0170] In one example, the air adapter tube further includes an indicator or guide adjacent the distal end, the indicator or guide being configured to align with a corresponding indicator or guide of the hot air delivery tube.

[0171] 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.

[0172] In one example, the air adapter tube further includes a mechanical connector provided at the distal end of the tubular body, the mechanical connector being configured to mechanically connect to a corresponding mechanical connector of the hot air delivery tube.

[0173] In one example, the air adapter tube further includes a power source configured to supply power to the sensor or the flexible printed circuit.

[0174] In one example, the air adapter tube further includes a plurality of sensors, the 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 at the proximal end during a treatment for diagnosing and / or treating a respiratory disorder. The second sensor is configured to generate a signal indicating a patient's sleep position. The third sensor is configured to generate a signal indicating the respiration and / or biomarkers of the gas exhaled by the patient before applying a treatment.

[0175] In one example, the air adapter tube further includes a first electrical connector configured to couple a first wire and a second electrical connector configured to couple a second wire, the first wire being configured to supply power to the air delivery tube, and the second wire being configured to send data to and receive data from the air delivery tube.

[0176] In one example, the antenna is an omnidirectional antenna, which includes a plurality of antennas oriented at different angles relative to each other.

[0177] In one example, the omnidirectional antenna includes two antennas.

[0178] In one example, the plurality of antennas includes at least a first antenna and a second antenna, wherein the first antenna and the second antenna are oriented at an angle of approximately 30 degrees to approximately 120 degrees relative to each other.

[0179] In one example, the plurality of antennas are set to a frequency of about 10 MHz to about 12 GHz.

[0180] In one example, the sensor is supported at the proximal end of the air adapter tube and / or its tubular body.

[0181] Another aspect of one form of the present technology relates to a medical device for diagnosing and / or treating a patient suffering from a respiratory disorder, the medical device 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 to the patient interface, and an air adapter tube.

[0182] In one example, the flow generator is configured to be controlled based on the output from the sensor.

[0183] Another aspect of one form of the present technology relates to a method for diagnosing and / or treating a patient, the method including: 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 diagnosing or treating the patient.

[0184] Another aspect of one form of the present technology relates to a system including an air adapter tube and at least one hardware processor configured to perform operations including controlling when the sensor is configured to sense a physical quantity.

[0185] In one example, the sensor is controlled based on the determined patient position. In one example, the sensor is controlled to sense the physical quantity before positive air pressure is delivered to the air adapter tube.

[0186] In one example, the sensor is controlled to sense the physical quantity based on determining that no positive air pressure is being delivered to the air adapter tube.

[0187] Another aspect of one form of the present technology relates to a system including an air adapter tube and at least one hardware processor configured to perform operations including changing at least one treatment parameter based on the generated sensor signal.

[0188] In one example, the system further includes a patient interface including an RFID tag, the RFID tag including data received by an antenna of the air adapter tube.

[0189] The described methods, systems, devices, and apparatuses can be implemented to improve the functionality of processors such as those of dedicated computers, respiratory monitors, and / or respiratory therapy devices. Additionally, the described methods, systems, devices, and apparatuses can provide improvements in the technical field of the automated management, monitoring, and / or treatment of respiratory conditions including, for example, sleep disordered breathing.

[0190] Of course, portions of these aspects may form sub - aspects of the present technology. Additionally, the various aspects within the sub - aspects and / or aspects may be combined in various ways and also constitute additional aspects or sub - aspects of the present technology.

[0191] Other features of the present technology will become apparent in view of the information contained in the following detailed description, the abstract, the drawings, and the claims. 4 BRIEF DESCRIPTION OF THE DRAWINGS

[0192] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like reference numerals refer to like elements and include:

[0193] Figures 1A to 1C Various configurations of a respiratory therapy system in use are shown respectively.

[0194] Figure 2 A patient interface in the form of a nasal mask according to one form of the present technology is shown.

[0195] Figure 3A Is a schematic diagram of the pneumatic path of an RPT device according to one form of the present technology. The upstream and downstream directions are indicated with reference to the blower and the patient interface. The blower is defined as being upstream of the patient interface and the patient interface is defined as being downstream of the blower, regardless of the actual flow direction at any particular moment. Articles within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0196] Figure 3B A schematic diagram of the electrical components of an RPT device according to one form of the present technology is shown.

[0197] Figure 3C A schematic diagram of an algorithm implemented in an RPT device according to one form of the present technology is shown.

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

[0199] Figure 4B A perspective view of a gasket of a patient interface that is configured to be worn by a patient and deliver pressurized air to the patient's nose is shown.

[0200] Figure 4C Shows that can be used with Figure 4A of the gasket or Figure 4B of the gasket is shown together with a perspective view of a tube.

[0201] Figure 4D Shows that can be used withFigure 4A The perspective view of the gasket or the rigid arm used together with the Figure 4B gasket.

[0202] Figure 4E The perspective view shows that it can be used together with the Figure 4A gasket.

[0203] Figure 4F The perspective view shows that it can be used together with the Figure 4B gasket.

[0204] Figure 4G The front view shows a pair of sleeves detachably assembled to the Figure 4C tube or the Figure 4D rigid arm.

[0205] Figure 4H The front view shows a complete sleeve detachably mounted on the Figure 4D rigid arm.

[0206] Figure 4I The front perspective view shows another alternative form of a complete sleeve removably assembled to the Figure 4D rigid arm.

[0207] Figure 4J It is a front view of a patient wearing a tube connected to the Figure 4C tube, the Figure 4E headgear strap and the Figure 4G sleeve with the Figure 4A gasket.

[0208] Figure 4K It is a front view of a patient wearing a rigid arm connected to the Figure 4D rigid arm, the Figure 4E headgear strap and the Figure 4H sleeve with the Figure 4A gasket.

[0209] Figure 4L It is a front view of a patient wearing a catheter headgear with the Figure 4C gasket and the Figure 4B headgear strap. Figure 4F headgear strap.

[0210] Figure 4M It is a front view of a patient wearing a rigid arm connected to the Figure 4D rigid arm, the Figure 4F headgear strap and the Figure 4I sleeve with the Figure 4B gasket.

[0211] Figure 4N It is Figure 4L the ventilation isolation perspective view.

[0212] Figure 4O is Figure 4M an isolated perspective view of a part of the air circuit.

[0213] Figure 4P is a schematic diagram showing possible combinations of patient interfaces.

[0214] Figure 5A shows a schematic diagram of a medical system according to aspects of the present invention.

[0215] Figure 5B shows a schematic diagram of an alternative medical system according to aspects of the present invention.

[0216] Figure 6A and 6B shows a perspective view of the proximal portion of the air circuit according to aspects of the present invention.

[0217] Figure 6C shows according to the aspects of Figure 6B the front view of the circuit board shown in

[0218] Figure 7A and Figure 7B shows the front view of an exemplary patient interface according to aspects of the present invention ( Figure 7A ) and the side view ( Figure 7B ).

[0219] Figure 8A and Figure 8B shows the rear view of an alternative exemplary patient interface according to multiple aspects of the present invention ( Figure 8A ) and the top view ( Figure 8B ).

[0220] Figures 9A to 9D shows various configurations of two or more antennas according to aspects of the present invention.

[0221] Figures 10A to 10D shows various configurations between multiple patient interfaces and the air circuit.

[0222] Figure 11 is a perspective view of an air adapter tube according to an example of the present technology, observed from the distal end.

[0223] Figure 12 is observed from the distal end Figure 11 of another perspective view of the air adapter tube.

[0224] Figure 13 is observed from the proximal end Figure 11 of another perspective view of the air adapter tube.

[0225] Figure 14 is observed from the proximal endFigure 11 Another perspective view of the air adapter tube.

[0226] Figure 15 The air adapter tube connected to the air delivery tube according to the present technical example Figure 11 Perspective view of the air adapter tube.

[0227] Figure 16 The air adapter tube connected to the air delivery tube according to the present technical example Figure 11 Another perspective view of the air adapter tube.

[0228] Figure 17 The air adapter tube connected to the air delivery tube according to the present technical example Figure 11 Perspective view of the air adapter tube.

[0229] Figure 18 The air adapter tube connected to the air delivery tube according to an example of the present technology Figure 11 Another perspective view of the air adapter tube.

[0230] Figure 19 The air adapter tube connected to the air delivery tube according to an example of the present technology Figure 11 Another perspective view of the air adapter tube.

[0231] Figure 20 The exploded view of the air adapter tube according to an example of the present invention Figure 11 of the air adapter tube.

[0232] Figure 21 The exploded view of the air adapter tube according to an example of the present invention Figure 11 Another exploded view of the air adapter tube.

[0233] Figure 22 The partial cross-sectional view of the air adapter tube according to an example of the present invention Figure 11 of the air adapter tube.

[0234] Figure 23 The exploded partial cross-sectional view of the air adapter tube according to an example of the present invention Figure 11 of the air adapter tube.

[0235] Figure 24 The exploded partial cross-sectional view of the air adapter tube according to an example of the present invention Figure 11 Another exploded partial cross-sectional view of the air adapter tube.

[0236] Figure 25 The exploded view of the end of the air delivery tube according to an example of the present technology.

[0237] Figure 26 The end of the air delivery tube according to an example of the present technology Figure 25 Another exploded view of the end of the air delivery tube.

[0238] Figure 27 is of the proximal end of an air adapter tube according to an example of the present technology Figure 11 Perspective view, with the ferrule portion removed, of the proximal end of an air adapter tube

[0239] Figure 28 is of the proximal end of an air adapter tube according to an example of the present technology Figure 11 Another perspective view, with the ferrule portion removed, of the proximal end of an air adapter tube

[0240] Figure 29 is of the proximal end of an air adapter tube according to an example of the present technology Figure 11 Another perspective view, with the ferrule portion removed, of the proximal end of an air adapter tube

[0241] Figure 30 is of the proximal end of an air adapter tube according to an example of the present technology Figure 11 End view, with the ferrule portion removed, of the proximal end of an air adapter tube

[0242] Figure 31 is of a partial cross - sectional view of an air adapter tube according to an example of the present invention Figure 11 of an air adapter tube

[0243] Figure 32 is of a cross - sectional view of an air adapter tube according to an example of the present invention Figure 11 with the ferrule portion removed

[0244] Figure 33 is of an air adapter tube connected to an air delivery tube according to an example of the present technology Figure 11 Perspective view of an air adapter tube

[0245] Figure 34 is a cross - sectional view taken along line 34 - 34 in Figure 33

[0246] Figure 35 is a cross - sectional view taken along line 35 - 35 in Figure 33

[0247] Figure 36 is of a cross - sectional view of an air adapter tube connected to a patient interface according to an example of the present technology Figure 11 of an air adapter tube

[0248] Figure 37 is of a cross - sectional view of an air adapter tube manually disconnected from a patient interface according to an example of the present technology Figure 11 of an air adapter tube

[0249] Figure 38 is a plan view of a flexible printed circuit according to an example of the present technology ​​

[0250] Figure 39 according to an example of the present invention Figure 11 exploded view of the air adapter tube 5 DETAILED DESCRIPTION

[0251] Before describing the technology in further detail, it should be understood that the technology is not limited to the specific examples described herein, and the specific examples described herein may be changed. It should also be understood that the terms used in the present invention are for the purpose of describing only the specific examples discussed herein and are not intended to be restrictive.

[0252] The following description is provided with respect to 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 other examples. Additionally, any single feature or combination of features in any one example may constitute another example.

[0253] Now, aspects of the present invention will be described in detail, and examples thereof are shown in the drawings. Where possible, the same or similar reference numerals will be used throughout the drawings to refer to the same or similar parts. The term "distal end" refers to the part that is farthest from the user (e.g., the patient). In contrast, the term "proximal end" refers to the part that is closest to the user.

[0254] The foregoing general description and the following detailed description are merely exemplary and explanatory and are not limiting of the claimed features. As used herein, the terms "comprising", "including", "having", "containing" or other variants thereof are intended to cover non-exclusive inclusion, such that a process, method, article or device that includes a series of elements includes not only those elements but also other elements that may not be expressly listed or are inherent to such process, method, article or device. In the present invention, relative terms such as "about", "substantially", "generally" and "approximately" are used for possible variations of ±10% of the stated value or feature.

[0255] 5.1 Therapy

[0256] In one form, the technology includes a method for treating a respiratory disorder, the method including applying positive pressure to the airway inlet of a patient 1000.

[0257] In certain examples of the technology, a positive pressure air supply is provided to the nasal passages of the patient via one or both nostrils.

[0258] In certain examples of the technology, mouth breathing is restricted, constrained or prevented.

[0259] 5.2 Respiratory Therapy System

[0260] In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system can include an RPT device 4000 for supplying an air stream to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0261] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal pillow receives an air supply under 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 along the air circuit 4170. A bed partner 1100 is also shown. The patient sleeps in a supine sleeping position.

[0262] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask and receiving a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along the air circuit 4170.

[0263] Figure 1C A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask and receiving a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along the air circuit 4170. The patient sleeps in a lateral sleeping position.

[0264] The RPT device 4000 according to one aspect of the technology includes mechanical, pneumatic, and / or electronic components and is configured to execute one or more algorithms 4300, such as any of the methods described in whole or in part herein. The RPT device 4000 can be configured to generate an air stream for delivery to a patient's airway, for example, for treating one or more respiratory conditions described elsewhere in this document.

[0265] In one form, the RPT device 4000 is constructed and arranged to be capable of delivering an air stream 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.

[0266] As Figure 1A 、 Figure 1B and Figure 1C shown, the patient 1000 can use the respiratory therapy system in various positions. Thus, the position of the patient interface 3000, for example, relative to the air circuit 4170 or other aspects of the respiratory therapy system, can vary throughout use.

[0267] 5.3 Patient Interface

[0268] According to one aspect of the present technology, as Figure 3A shown, the non-invasive patient interface 3000 includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilization structure 3300, ventilation 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the airway inlet of the patient so as to maintain positive pressure at the airway inlet of the patient 1000. Accordingly, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0269] 5.3.1 Inflatable Chamber

[0270] The inflatable chamber 3200 has a perimeter that is shaped to be complementary to the surface profile of an average person's face in the area that will form a seal in use. In use, the boundary edges of the inflatable chamber 3200 are positioned in close proximity to adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire perimeter of the inflatable chamber 3200 in use. In some forms, the inflatable chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous sheet of material.

[0271] In certain forms of the present technology, the inflatable chamber 3200 does not cover the patient's eyes in use. In other words, these eyes are outside the pressurized volume defined by the inflatable chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with the therapy.

[0272] In certain forms of the present technology, the inflatable chamber 3200 is constructed from a transparent material (such as clear polycarbonate). The use of a transparent material can reduce the obtrusiveness of the patient interface and can help improve compliance with the therapy. The use of a transparent material can assist the clinician in observing how the patient interface is positioned and functioning.

[0273] In certain forms of the present technology, the pneumatic chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and can help improve compliance with the treatment.

[0274] In some forms, the inflatable chamber 3200 is constructed from a rigid material such as polycarbonate. The rigid material can provide support for the seal-forming structure.

[0275] In some forms, the inflatable chamber 3200 is made of a flexible material (e.g., a soft, flexible, elastic material such as silicone, fabric, foam, etc.). For example, in an instance, it can be formed of a material having a Young's modulus of 0.4 GPa or less, such as foam. In some forms of the present technology, the inflatable chamber 3200 can be made of a material having a Young's modulus of 0.1 GPa or less, such as rubber. In other forms of the present technology, the inflatable chamber 3200 can be made of a material having a Young's modulus of 0.7 MPa or less (e.g., between 0.7 MPa and 0.3 MPa). An example of such a material is silicone resin.

[0276] 5.3.1.1 Multiple openings

[0277] As Figure 4A and Figure 4B shown, different inflatable chambers 3200-1, 3200-2 can be formed as part of multi-opening gaskets 3050-1, 3050-2. In the illustrated instance, the gaskets 3050-1, 3050-2 each include three openings, but alternative gaskets can be formed with more or fewer openings.

[0278] In some forms, the different openings can serve different functions. For example, some openings can be only inlet openings, while other openings can be only outlet openings.

[0279] In other forms, at least one opening can provide two different functions. For example, during the same breathing cycle, one opening can be used as both an inlet and an outlet.

[0280] The multiple openings can allow for multiple configurations of delivering air to the inflatable chambers 3200-1, 3200-2. For example, depending on the patient's needs and / or the patient's comfort, the patient can use a given gasket 3050-1, 3050-2 in an "upper tube" configuration (e.g., using a catheter headgear - described below) or a "lower tube" configuration (e.g., using a single catheter in front of the patient's face).

[0281] 5.3.1.1.1 Nasal-oral mask

[0282] As Figure 4A shown, the inflatable chamber 3200-1 includes a pair of inflatable chamber inlet ports 3254-1, which can be used to deliver gas into and / or out of the inflatable chamber 3200-1. The inflatable chamber inlets 3254-1 can be disposed on opposite sides of the inflatable chamber 3200-1 (e.g., left and right sides).

[0283] In some forms, the inflatable chamber 3200-1 can also include at least one vent 3402-1 (see, for example Figure 4A)。The ventilation opening 3402-1 can be provided at the center of the inflation chamber 3200-1. For example, the ventilation 3402-1 can be provided between the inflation chamber inlets 3254-1.

[0284] In some forms, the inflation chamber 3200-1 can include a pair of grooves 3266-1. Each groove 3266-1 can be provided near one of the inflation chamber inlets 3254-1. Each groove 3266-1 can form a partially recessed surface.

[0285] 5.3.1.1.2 Pure nasal mask

[0286] Only the inflation chamber 3200-2 of the nasal cushion 3050-2 can be similar to the inflation chamber 3200-1 of the oro-nasal cushion 3050-1. Only some similarities and differences between the inflation chambers 3200-1 and 3200-2 are described below.

[0287] As Figure 4B shown, the inflation chamber 3200-2 includes a pair of inflation chamber inlet ports 3254-2, which can be used to deliver gas into and / or out of the inflation chamber 3200-2. The inflation chamber inlets 3254-2 can be provided on opposite sides of the inflation chamber 3200-2 (e.g., left and right sides).

[0288] In some forms, the inflation chamber 3200-2 can also include at least one ventilation 3402-2 (see, for example Figure 4B ). The ventilation opening 3402-2 can be provided at the center of the inflation chamber 3200-2. For example, the ventilation 3402-2 can be provided between the inflation chamber inlets 3254-2.

[0289] In some forms, the inflation chamber 3200-2 can include a pair of grooves 3266-2. Each groove 3266-2 can be provided near one of the inflation chamber inlets 3254-2. Each groove 3266-2 can form a partially recessed surface.

[0290] 5.3.2 Positioning and stabilization structure

[0291] In one form, the positioning and stabilization structure 3300 provides a holding force as a safety margin to overcome the potential impact of disturbing forces on the patient interface 3000, such as those from tube resistance or accidental interference with the patient interface.

[0292] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured to conform to the way a patient wears it while sleeping. In one instance, the positioning and stabilization structure 3300 has a small profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one instance, the positioning and stabilization structure 3300 includes at least one strap with a rectangular cross-section. In one instance, the positioning and stabilization structure 3300 includes at least one flat strap.

[0293] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured to not be so large and bulky as to prevent the patient from lying on their back with the posterior region of the patient's head on the pillow.

[0294] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured to not be so large and bulky as to prevent the patient from lying on their side with the lateral region of the patient's head on the pillow.

[0295] In one form of the present technology, the positioning and stabilization structure 3300 is provided with a decoupling portion located between the front portion of the positioning and stabilization structure 3300 and the rear portion of the positioning and stabilization structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible or soft strap. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, the presence of the decoupling portion prevents forces on the rear portion from being transmitted along the positioning and stabilization structure 3300 and breaking the seal.

[0296] In one form of the present technology, the positioning and stabilization structure 3300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes a loop material that engages a hook material portion.

[0297] In certain forms of the present technology, the positioning and stabilization structure 3300 includes an extendable strap, such as an elastically extendable strap. For example, the strap can be configured to be in a tensioned state during use and direct forces to cause a seal-forming structure to be in sealing contact with a portion of the patient's face. In an instance, the strap can be configured as a tie.

[0298] In one form of the present technology, the positioning and stabilization structure includes a first tie that is constructed and arranged such that in use, at least a portion of its lower edge passes over the supra-aural base point of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0299] In one form of the present technology applicable to a nasal mask only or a full face mask, the positioning and stabilizing structure includes a second strap that is configured and arranged such that at least a portion of its upper edge passes below the subauricular base point of the patient's head and covers or is located below the occipital bone of the patient's head during use.

[0300] In one form of the present technology applicable to a nasal mask only or a full face mask, the positioning and stabilizing structure includes a third strap that is configured and arranged to interconnect the first strap and the second strap to reduce the tendency for the first strap and the second strap to separate from each other.

[0301] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a bendable and, for example, non-rigid strap. The advantage of this aspect is that the strap is more comfortable for the patient when the patient is sleeping.

[0302] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes a strap that is configured to be breathable to allow moisture to be transmitted through the strap.

[0303] In certain forms of the present technology, a system including more than one positioning and stabilizing structure 3300 is provided, each positioning and stabilizing structure 3300 being configured to provide a holding force corresponding to a different size and / or shape range. For example, the system can include one form of the positioning and stabilizing structure 3300 that is suitable for a large-sized head but not for a small-sized head, and another form that is suitable for a small-sized head but not for a large-sized head.

[0304] 5.3.2.1 Catheter headgear

[0305] 5.3.2.1.1 Catheter headgear tube

[0306] In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more headgear tubes 3350 that convey pressurized air received from a catheter forming part of the air circuit 4170 from the RPT device to the patient's airway, for example, through the pneumatic chamber 3200 and the seal-forming structure 3100. In Figure 4J The form of the present technology shown, the positioning and stabilizing structure 3300 includes two tubes 3350 that convey air from the air circuit 4170 to the inflation chamber 3200. The tubes 3350 are configured to position and stabilize the seal-forming structure 3100 of the patient interface 3000 at an appropriate portion of the patient's face (e.g., the nose and / or mouth) during use. This allows the catheter of the air circuit 4170 that provides the pressurized air flow to be connected to the connection port 3600 of the patient interface, which is in a position other than the front of the patient's face, such as on top of the patient's head.

[0307] InFigure 4J In the form of the present technique shown, the positioning and stabilization structure 3300 includes two tubes 3350, each tube 3350 being positioned on a different side of the patient's head in use and extending through the corresponding cheek region, above the corresponding ear (above the supra-aural reference point of the patient's head) to an elbow 3610 on the top of the patient 1000's head. This form of the technique may be advantageous because if the patient sleeps on their side and one of the tubes 3350 is in a compressed state to block or partially block the gas flow along the tube 3350, the other tube 3350 remains open to supply pressurized gas to the patient. In other instances of the technique, the patient interface 3000 may include a different number of tubes, such as one tube, or two or more tubes.

[0308] In one instance 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., across one cheek region), and a strap forms part of the positioning and stabilization structure 3300 and is positioned on the other side of the patient's head in use (e.g., across another region) to help secure the patient interface 3000 to the patient's head. For example, the tube 3350 and the strap may each be under tension in use to help maintain the seal-forming structure 3100 in the sealed position.

[0309] In one form, the tube 3350 may be at least partially extensible such that the tube 3350 and the strap can be adjusted to substantially equal lengths when worn by the patient. This may allow for substantially symmetric adjustment between the tube 3350 and the strap such that the seal-forming structure remains substantially centered.

[0310] In Figure 4J In the form of the technique shown, the two tubes 3350 are fluidly connected to each other at their upper ends and connected to a connection port 3600. In some instances, the two tubes 3350 are integrally formed, while in other instances, the tubes 3350 are formed separately but are connected and separable in use, for example for cleaning or storage. In the case of using separate tubes, they may be indirectly connected together, such as each being connected to a T-shaped connector. The T-shaped connector may have two arms / branches, each arm / branch being fluidly connectable to a corresponding one of the tubes 3350. Additionally, the T-shaped connector may have a third arm or opening that provides a connection port 3600 for fluid connection to the air circuit 4170 in use. The opening may be an inlet 3332 for receiving a pressurized air flow (see, for example, 4C).

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

[0312] In some forms, the third arm of the T-shaped connector can be formed at an angle relative to each of the first two arms.

[0313] In some forms, a Y-shaped connector can be used instead of the T-shaped connector. The first two arms can be angled relative to each other, and the third arm can be angled relative to the first two arms. The angled formation of the first two arms can be similar to the shape of the patient's head so as to conform to that shape.

[0314] In some forms, at least one arm of the T-shaped connector (or Y-shaped connector) can be flexible. This can allow the connector to bend based on the shape of the patient's head and / or the forces in the positioning and stabilization structure 3300.

[0315] In some forms, at least one arm of the T-shaped connector (or Y-shaped connector) can be at least partially rigidified. This helps to maintain the shape of the connector such that bending of the connector does not block the air flow path.

[0316] The tube 3350 can be formed of a flexible material such as an elastomer, e.g., silicone or TPE, and / or formed of one or more textile and / or foam materials. The tube 3350 can have a preformed shape and be capable of bending or moving into another shape when a force is applied, but can return to the original preformed shape when the force is absent. The shape of the tube 3350 can be generally arcuate or curved, approximating the contour of the patient's head between the top of the head and the nose or oral region.

[0317] In some instances, the one or more tubes 3350 are crush-resistant to resist being blocked if squeezed during use (e.g., if pressed between the patient's head and a pillow, especially if there is only one tube 3350). The tube 3350 can be formed to have sufficient structural stiffness to resist squeezing or can be as described in U.S. Patent No. 6,044,844, the content of which is incorporated herein by reference.

[0318] Each tube 3350 can be configured to receive an air flow from a connection port 3600 on top of the patient's head and convey the air flow to a seal-forming structure 3100 at the entrance of the patient's airway. In Figure 4JIn the illustrated example, each tube 3350 is located on a path extending from the inflation chamber 3200 through the patient's cheek region and above the patient's ear to the elbow tube 3610. For example, a portion of each tube 3350 near the inflation chamber 3200 may overlie the maxillary region of the patient's head in use. Another portion of each tube 3350 may overlie a region of the patient's head that is above the supraauricular base point of the patient's head. Each of the tubes 3350 may also be located over any one or both of the patient's sphenoid bone and / or temporal bone and the patient's frontal bone and parietal bone. The elbow tube 3610 may be located over the patient's parietal bone, over the patient's frontal bone, and / or over the junction therebetween (e.g., the coronal suture) in use.

[0319] In some forms of the present technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned within a range of positions spanning the top of the patient's head, such that the patient interface 3000 can be positioned to suit the comfort or fit of an individual patient. In some examples, the head cannula 3350 is configured to allow movement of an upper portion of the patient interface 3000 (e.g., the connection port 3600) relative to a lower portion of the patient interface 3000 (e.g., the inflation chamber 3200). That is, the connection port 3600 can be at least partially decoupled from the inflation chamber 3200. In this way, the seal forming structure 3100 can form an effective seal with the patient's face, regardless of the position of the connection port 3600 on the patient's head (at least within a predetermined range of positions).

[0320] As described above, in some examples of the present technology, the patient interface 3000 includes a seal forming structure 3100 in the form of a nasal bridge pad that is generally located beneath the nose and seals to the lower periphery of the nose (e.g., a pad beneath the nose). The positioning and stabilization structure 3300 including the tubes 3350 can be constructed and arranged to pull the seal forming structure 3100 beneath the nose into the patient's face with a sealing force vector in a posterior and upward direction (e.g., a posterosuperior direction). A sealing force vector having a posterosuperior direction can cause the seal forming structure 3100 to form a good seal with the lower periphery of the patient's nose and the anterior-facing surface of the patient's face, such as on either side of the patient's nose and the upper lip region of the patient.

[0321] 5.3.2.1.2 Extendable and non-extendable tube portions

[0322] In some examples of the present technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tube 3350 can include one or more extendable tube segments, such as formed by an extendable accordion structure. In some forms, the patient interface 3000 can include a positioning and stabilization structure 3300 that includes at least one gas delivery tube that includes a tube wall having an extendable accordion structure. Figure 4J The illustrated patient interface 3000 includes a tube 3350, the upper portion of the tube 3350 including an extendable tube segment, each tube segment being in the form of an extendable accordion structure 3362.

[0323] In some forms, the extendable accordion structure 3328 can be formed as a series of ridges and grooves on the surface of the tube 3350. The accordion structure 3328 can be biased towards a retracted position and can move to an extended position when the patient is in the prone positioning and stabilization structure 3300. Because portions of the tube 3350 can be substantially non-extendable (e.g., non-extendable tube segment 3363), the accordion structure 3328 allows the positioning and stabilization structure 3300 to extend to fit different sized heads. This can allow a single sized tube 3350 to be used with multiple sized heads. For example, as a result of the accordion structure 3328, the positioning and stabilization structure 3300 can be "full sized". Alternatively, the tube 3350 can be manufactured in multiple sizes (e.g., small, medium, large). The patient can select the length that most closely matches their head, and the accordion structure 3328 can make minor adjustments to fit the individual patient.

[0324] In some forms, the inlet 3332 can be disposed in the middle of the conduit 6320. For example, the tube 3350 can be symmetric about the inlet 3332 by at least one axis.

[0325] The cross-sectional shape of the non-extendable tube segment 3363 of the tube 3350 can be circular, oval, ovoid, D-shaped, or rounded rectangular, for example, as described in U.S. Patent No. 6,044,844. A cross-sectional shape that presents a flattened surface of the tube on the side facing and contacting other parts of the patient's face or head can be more comfortably worn compared to, for example, a tube having a circular cross-section.

[0326] In some examples of the present technology, the non-extendable tube segment 3363 is connected to the inflatable chamber 3200 at a low angle. The head cannula 3350 can extend downward along both sides of the patient's head and then bend forward and inward to connect to the inflatable chamber 3200 at the front of the patient's face. Before connecting to the inflatable chamber 3200, the tube 3350 can extend to the same vertical position as the connection to the inflatable chamber 3200 (or in some examples, below the connection to the inflatable chamber 3200). That is, the tube 3350 can protrude in at least a partially upward direction before connecting to the inflatable chamber 3200. A portion of the tube 3350 can be located below the inflatable chamber 3200 and / or the seal-forming structure 3100. The tube 3350 can contact the patient's face below the patient's cheekbone, which can be more comfortable than contacting on the patient's cheekbone and can avoid overly obscuring the patient's peripheral vision.

[0327] 5.3.2.1.3 Catheter Headset Connection Port

[0328] In certain forms of the present technology, the patient interface 3000 can include a connection port 3600 located near the upper, outer, or rear portion of the patient's head. For example, in Figure 4J the form of the present technology shown, the connection port 3600 is located at the top of the patient's head (e.g., relative to the upper position of the patient's head). In this example, the patient interface 3000 includes an elbow 3610 that forms the connection port 3600. The elbow 3610 can be configured to be fluidly connected to a catheter of the air circuit 4170. The elbow 3610 can be configured to rotate relative to the positioning and stabilizing structure 3300 to at least partially decouple the catheter from the positioning and stabilizing structure 3300. In some examples, the elbow 3610 can be configured to rotate by rotating about a substantially vertical axis, and in some particular examples, by rotating about two or more axes. In some examples, the elbow can include the tube 3350 or be connected to the tube 3350 by a ball-and-socket joint. In use, the connection port 3600 can be located in the sagittal plane of the patient's head.

[0329] Patient interfaces having connection ports that are not positioned in front of the patient's face may be advantageous because some patients may find the tubing connected to a patient interface positioned in front of the patient's face to be unaesthetic and / or obtrusive. For example, tubing connected to a patient interface positioned in front of the patient's face may be prone to snagging on bedding, especially if the tubing extends downward from the patient interface during use. Forms of the present technology that include patient interfaces having connection ports positioned above the patient's head during use may allow the patient to lie or sleep more easily or comfortably in one or more of the following positions: a side-lying position, a supine position (e.g., on their back, typically facing upward), or a prone position (e.g., on their front, typically facing downward). Additionally, connecting the tubing to the front portion of the patient interface may exacerbate a problem known as tube drag, where during movement of the patient's head or the tubing, the tubing exerts an undesirable force on the patient interface, resulting in displacement away from the face. Tube drag may be less of a problem when the force is received at a location above the patient's head rather than in front of the patient's face near the seal-forming structure (where tube drag may be more likely to break the seal).

[0330] 5.3.2.1.4 Head cannula fluid connection

[0331] Two tubes 3350 are fluidly connected to the pneumatic chamber 3200 at their lower ends. In some forms of the technology, the connection between the tubes 3350 and the inflation chamber 3200 is achieved through the connection of two rigid connectors. The tubes 3350 and the inflation chamber 3200 may be configured such that the patient can easily connect the two components together in a reliable manner. The tubes 3350 and the inflation chamber 3200 may be configured to provide tactile and / or audible feedback in the form of a "satisfying click" or similar sound such that the patient can easily know that each tube 3350 has been correctly connected to the inflation chamber 3200. In one form, the tubes 3350 are formed of silicone or textile material, and the lower end portion of each silicone tube 3350 is overmolded to a rigid connector made of, for example, polypropylene, polycarbonate, nylon, etc. The rigid connectors on each tube 3350 may include concave mating features configured to connect to convex mating features on the inflation chamber 3200. Alternatively, the rigid connectors on each tube 3350 may include convex mating features configured to connect to concave mating features on the inflation chamber 3200. In other instances, each tube 3350 may include a convex or concave connector formed of a flexible material such as silicone or TPE, e.g., the same material forming the tube 3350.

[0332] In other instances, compression seals are used to connect each tube 3350 to the plenum chamber 3200. For example, a resiliently flexible (e.g., silicone) tube 3350 without a rigid connector can be configured to withstand squeezing to reduce its diameter such that it can be compressed into a port in the plenum chamber 3200, and the inherent resiliency of the silicone pushes the tube 3350 outward to seal the tube 3350 in the port in an airtight manner. Alternatively, in a hard-to-hard engagement between the tube 3350 and the plenum chamber 3200, each tube 3350 and / or the plenum chamber 3200 can include a pressure-activated seal, such as a peripheral seal flange. When pressurized gas is supplied through the tube 3350, the seal flange can be pushed against the junction between the tube and the circumferential surface of the port or connector surrounding the plenum chamber 3200 to form or enhance the seal between the tube 3350 and the plenum chamber 3200.

[0333] 5.3.2.2 Headgear strap

[0334] In some forms, the positioning and stabilizing structure 3300 can include a headgear 3302 having at least one strap that can be worn by a patient to assist in properly orienting the seal-forming structure 3100 relative to the patient's face (e.g., to limit or prevent leakage).

[0335] As described above, some forms of the headgear 3302 can be constructed of a fabric material that can comfortably abut against the patient's skin. The fabric can be flexible to conform to various facial profiles. Although the fabric can include rigid members along selected lengths, this can limit the bending, flexing, and / or stretching of the headgear 3302.

[0336] In certain forms, the headgear 3302 can be at least partially extensible. For example, the headgear 3302 can include an elastic or similar extensible material. For example, the entire headgear 3302 can be extensible, or selected portions can be extensible (or more extensible than surrounding portions). This can allow the headgear 3302 to stretch in a tensioned state, which can help provide a sealing force for the seal-forming structure 3100.

[0337] Two forms of headgear, a four-point headgear 3302-1 and a two-point headgear 3302-2, are discussed in more detail below as illustrative examples.

[0338] 5.3.2.2.1 Four-point connection

[0339] As Figure 4EAs shown, some forms of the headgear 3302-1 can be four-point connection headgears. This means that the headgear 3302-1 can be connected to four separate locations on the inflatable chamber 3200, to the frame of the inflatable chamber 3200, and / or to the arms of the inflatable chamber 3200. The headgear 3302-1 can include four different straps that provide tension to help hold the seal forming structure 3100 in the sealed position.

[0340] In some forms, the headgear 3302-1 can include a lower strap 3304-1, which can be connected to the lower portion of the gasket 3050-1. The lower strap 3304-1 can extend along the patient's cheek towards the posterior region of the patient's head. For example, the lower strap 3304-1 can cover the masseter muscle on either side of the patient's face. Thus, the lower strap 3304-1 can contact the patient's head below the patient's ear. The lower strap 3304-1 can meet at the back of the patient's head and can cover the occipital bone and / or the trapezius muscle.

[0341] The headgear 3302-1 can also include an upper strap 3305-1, which can cover the temporal bone, the parietal bone, and / or the occipital bone. The upper strap 3305-1 can also be connected to the tube 3350 (e.g., by connecting to the tab 3320).

[0342] The rear strap 3307-1 can extend between the upper strap 3305-1 and the lower strap 3304-1. The lower and upper straps 3304-1, 3305-1 on a given side (e.g., left or right) can also be connected to the rear strap 3307-1 adjacent to each other. Thus, the height of the rear strap 3307-1 can be approximately the combined height of the lower strap 3304-1 and the upper strap 3305-1. The rear strap 3307-1 can cover the occipital bone and / or the parietal bone in use. This can allow the rear strap 3307-1 to help anchor the headgear 3302-1 to the patient's head.

[0343] In the illustrated example, the headgear 3302-1 can be formed in a generally X shape. The lower strap 3304-1 and the upper strap 3305-1 can be connected to the rear strap 3307-1 using stitching, ultrasonic welding, or any similar process.

[0344] In some forms, the lower strap 3304-1 is connected to a magnetic member 3306-1. For example, each lower strap 3304-1 can pass through the magnetic member 3306-1 such that the length of each lower strap 3304-1 can be adjusted. The magnetic member 3306-1 can be removably connected to a magnet 3370-1 (described below) such that the lower strap 3304-1 can be disconnected from the inflatable chamber 3200, but the length of the lower strap 3304-1 can be unaffected.

[0345] In some forms, the upper strap 3305-1 can be directly connected to the tab 3320 of the tube 3350. The upper strap 3305-1 can pass through the tab 3320 to adjust the length and control the tension of each upper strap 3305-1.

[0346] In some forms, the headgear 3302-1 can be used only with the nasal-oral cushion 3050-1 (e.g., because only the nasal cushion 3050-1 does not have four connection points). However, the headgear 3302-1 can be used interchangeably with the tube 3350 and the rigid arm 3340.

[0347] 5.3.2.2.2 Two-point connection

[0348] As Figure 4F shown, some forms of the headgear 3302-2 can be two-point connection headgears. This means that the headgear 3302-2 can be connected to two separate locations.

[0349] In some forms, the headgear 3302-2 can be formed from a continuous piece of material. In other words, the headgear 3302-2 can not be formed from multiple straps that are connected (e.g., sewn) together. This can be comfortable for the patient because they do not come into contact with any seams or joints that connect different straps. In other forms, the headgear 3302-2 can be formed from multiple straps (e.g., two upper straps, a rear strap, etc.) that are connected together (e.g., by sewing, ultrasonic welding, etc.).

[0350] In certain forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headgear strap in addition to the tube 3350, and the headgear strap is used to position and stabilize the seal-forming structure 3100 at the entrance of the patient's airway. As Figure 4F shown, the patient interface 3000 includes a rear strap 3307-2 that forms part of the positioning and stabilizing structure 3300. The rear strap 3307-2 can be referred to as the rear strap or the rear headgear strap, for example. The rear strap 3307-2 can cover the temporal bone, the parietal bone, and / or the occipital bone. In other examples of the present technology, one or more additional straps can be provided. For example, a patient interface 3000 with a nasal-oral cushion according to an example of the present technology can have a second lower strap that is configured to rest on the patient's head near the patient's neck and / or on the posterior surface of the patient's neck.

[0351] As Figure 4FAs shown, some forms of the headgear 3302-2 can be at least partially bifurcated. For example, the rear strap 3307-2 of the headgear 3302-2 (e.g., configured to contact the rear of the patient's head) can be wider than the peripheral portion of the headgear 3302-2. The middle portion 3308-2 of the rear strap 3307-2 can include a slit 3309-2. Thus, due to the slit 3309-2, the upper portion of the rear strap 3307-2 can move relative to the lower portion. This can allow the patient to have greater strap coverage over the rear region of their head, which can help better anchor the headgear 3302-2 to the patient's head since there is no lower strap (e.g., 3304-1).

[0352] In some forms, the headgear 3302-2 can be used only with the nasal cushion 3050-2 (e.g., because the oronasal cushion 3050-1 does not have four attachment points). However, the headgear 3302-2 can be used interchangeably with the tube 3350 and the rigid arm 3340.

[0353] 5.3.2.3 Rigid Arm

[0354] As Figure 4D shown, the rigid arm 3340 can be an elongate rigid member that helps hold a cushion (e.g., the oronasal cushion 3050-1 or the nasal cushion 3050-2) in an operative position. The rigid arm 3340 can contact one side of the patient's head and provide a force to limit the sliding of the seal-forming structure 3100 from the patient's nose and / or mouth.

[0355] In some forms, the inflatable chamber 3340 is made of a rigid material such as polycarbonate. The rigid material does not allow the rigid arm 3340 to stretch.

[0356] In some forms, the rigid arm 3340 can be flexible in at least one direction. For example, the rigid arm 3340 can be flexible about its width and can be non-bendable along its length. In other words, the rigid arm 3340 can bend about an axis along the width of the rigid arm 3340, but cannot bend about an axis perpendicular to the rigid arm 3340. This can allow an individual patient to adjust the rigid arm 3340 for a better fit to their individual head.

[0357] In certain forms, the rigid arm 3340 can remain in a new position after bending. This can allow the patient to adjust the shape of the rigid arm 3340 for their particular head, and then the rigid arm 3340 will maintain the desired shape during use to enhance the patient's comfort.

[0358] In some forms, the first end 3342 of the rigid arm 3340 can be a free end, while the second end 3344 of the rigid arm 3340 (e.g., opposite the first end 3342) can be fixed. The first end 3342 can be curved to minimize sharp edges that may cause patient discomfort. In use, the first end 3342 can also cover the patient's head near the temporal bone. The second end 3344 can be fixed to the arm connection structure 3504.

[0359] In some forms, the arm connection structure 3504 can be similar to the conduit connection structure 3500. For example, the arm connection structure 3504 and the conduit connection structure 3500 can have substantially the same shape. This can allow the conduit connection structure 3500 or the arm connection structure 3504 to be assembled into a groove (e.g., 3266-1 or 3266-2) and connected to the inflation chamber inlet 3254. The arm connection structure 3504 can be connected to the mouth-nose cushion 3050-1 or the nasal-only cushion 3050-2 in substantially the same manner as the conduit connection structure 3500 (e.g., via snap fit, press fit, friction fit, etc.).

[0360] In some forms, the arm connection structure 3504 can be used as a plug for the inflation chamber inlet port 3254 (e.g., 3254-1 and / or 3254-2). Different from the tube 3350, the rigid arm 3340 does not deliver pressurized air to the inflation chamber 3200. The rigid arm 3340 can be used with a "lower tube" configuration, where a hose is connected to the ventilation opening 3402 (e.g., 3402-1 and / or 3402-2) and delivers air into the inflation chamber 3200 through the ventilation opening 3402. In this instance, air does not need to travel into or out of the inflation chamber inlet port 3254. Thus, the arm connection structure 3504 can form a seal with the inflation chamber inlet port 3254 to restrict air flow into or out of the inflation chamber 3200.

[0361] 5.3.3 Ventilation

[0362] In one form, the patient interface 3000 includes a ventilation 3400 that is configured and arranged to allow the flushing of exhaled gas (e.g., carbon dioxide).

[0363] In certain forms, the ventilation 3400 is configured to allow a continuous airflow from the interior of the inflation chamber 3200 to the surrounding environment while the pressure inside the inflation chamber is positive relative to the surrounding environment. The ventilation 3400 is configured such that the airflow rate has a magnitude sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining the therapeutic pressure in the inflation chamber during use.

[0364] One form of the ventilation 3400 according to the present technology includes a plurality of holes, e.g., about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0365] The vent 3400 can be located within the plenum chamber 3200. Alternatively, the vent 3400 is located within a decoupling structure, such as a rotating body.

[0366] As Figure 4N shown, the vent 3450 can be used with the patient interface 3000. The vent 3450 can have a shape that is substantially similar to the vent opening 3402-1 (e.g., a substantially circular shape).

[0367] The vent 3450 can be used with the oral and nasal plenum chamber 3200-1 (e.g., as Figure 4A shown) or only the nasal plenum chamber 3200-2 (e.g., Figure 4B shown).

[0368] Continuing to refer to Figure 4A , the vent 3450 can include a vent housing 3404 that can be configured to engage with the vent opening 3402. The vent housing 3404 can be constructed of a rigid or semi-rigid material. For example, the vent housing 3404 can be constructed of plastic, metal, or any similar material. The vent housing 3404 can increase the rigidity of the patient interface 3000 (e.g., to limit unwanted flexure that may affect the position of the seal-forming structure 3100 on the patient's face).

[0369] The vent housing 3404 can include a front surface 3408, a rear surface 3412, and a groove 3416. The front surface 3408 faces away from the patient's face in use and can be positioned outside the pressurized plenum chamber 3200. The rear surface 3412 is disposed opposite the front surface 3408. In use, the rear surface 3412 can face the patient and can be disposed within the pressurized volume of the plenum chamber 3200. The groove 3416 can be formed between the front surface 3408 and the rear surface 3412. A portion of the plenum chamber 3200 can be received within the groove 3416 to hold the vent 3400 in place.

[0370] In some forms, a diffuser 3448 can be used with the vent housing 3404. The diffuser 3448 can help limit the decibel output from any patient interface 3000 (or any other patient interface). Specifically, the diffuser 3448 can help limit the decibel level associated with the air output (e.g., exhaled air) from the patient interface 3000, although the diffuser 3448 can limit the decibel level at any point within the patient interface.

[0371] In some forms, the diffuser 3448 can diffuse and thus slow down the exhaust gas that exits the inflation chamber 3200 and passes through the venting housing 3404. The diffuser 3448 can help avoid jetting and associated discomfort to the patient and / or bed partner (e.g., noise caused by jetting pillows, sheets, bedding, etc.).

[0372] In some forms, the diffuser can include a front surface 3456 that faces away from the patient in use. The outer diameter of the front surface 3456 can be smaller than the inner diameter of the venting housing 3404 proximate the front surface 3408. This can form a gap 3464 through which air can pass.

[0373] 5.3.4 Decoupling Structure

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

[0375] 5.3.5 Modularity

[0376] As described above, the gasket, headgear, and sleeve can have different styles, which can correspond to different uses (e.g., mouth breathing, nasal breathing, etc.). The patient or clinician can select certain combinations of the gasket, headgear, and sleeve in order to optimize the effectiveness of the treatment and / or the comfort of the individual patient. Examples of such modular designs are described in PCT / SG2022 / 050777, filed on October 28, 2022, the entire content of which is incorporated herein by reference.

[0377] In some forms, different types of gaskets, headgears, and sleeves can be interchangeably used with one another in order to form different combinations of the patient interface. This can be beneficial from a manufacturing perspective, as fewer components can be used to create a greater variety of patient interfaces. Additionally or alternatively, the various combinations can allow the patient to change the type of patient interface without changing each component.

[0378] Air can be delivered to the patient in one of two main ways. In one example, the patient can receive a pressurized air stream through the head tube 3350 (see, for example Figure 4C 、 4J ). This can be referred to as an "upper tube" configuration, and the connection port can be positioned at the top of the patient's head. In other examples, the patient can receive a pressurized air stream through a catheter connected to the inflation chamber 3200. This can be referred to as a "lower tube" configuration, where the air flow conduit is located in front of the patient's face. Different patients are more comfortable with one type of air delivery than the other (e.g., due to the patient's sleep type). Thus, it can be beneficial to allow a single type of patient interface to be used in an "upper tube" or "lower tube" configuration.

[0379] The patient interface can be part of a modular assembly with various interchangeable components that can be swapped out by the patient and / or clinician for one or more different types of components. The following describes various combinations that can result from assembling different components together.

[0380] 5.3.5.1 Sleeve

[0381] In some forms, to allow for modularity, the sleeve can be used with the tube 3350 and / or the rigid arm 3340. The sleeve can at least partially surround the tube 3350 and / or the rigid arm 3340. As Figures 4G to 4I shown, sleeves of different shapes can be used, which can correspond to different types of positioning and stabilization structures 3300. In some forms, the construction of the sleeve can be customized to fit the face of a particular user. For example, the sleeve can be constructed in a relatively more posterior region of the patient's head.

[0382] In some forms, the sleeve can be constructed of a comfort material. For example, the sleeve can be constructed of a fabric material, a foam material, or a combination of both. The comfort material can contact the patient during use and can feel soft against the patient's skin to improve patient compliance.

[0383] The material can also be flexible to help put on or take off the sleeve from the tube 3350 or the rigid arm 3340. For example, the material can allow the sleeve to bend to conform to the shape of the tube 3350 or the catheter headgear or the rigid arm 3340, which can vary according to the shape of an individual patient's head.

[0384] In some forms, the sleeve can also be at least partially elastic (e.g., the material can allow the sleeve to stretch). The elastic material can help the sleeve expand to fit around the tube 3350 or the rigid arm 3340. The elastic material can then return to its initial position snug against the tube 3350 or the rigid arm 3340 to limit slippage of the sleeve during use.

[0385] As described in more detail below, some forms of the sleeve can be dedicated to the stiffening element (e.g., the tube 3350 and / or the rigid arm 3340). However, the sleeve can help the stiffening element connect interchangeably with different versions or styles of the gasket (e.g., the oronasal gasket 3050-1, the nasal-only gasket 3050-2, etc.).

[0386] 5.3.5.2 Catheter Sleeve

[0387] As Figure 4G shown, an example of a sleeve is the catheter sleeve 3351, which can be used with the tube 3350 described above.

[0388] As Figure 4GAs shown, the catheter sleeve 3351 may include a curved shape similar to that of the tube 3350 shown in Figure 4C . The flexible material used to construct the catheter sleeve 3351 may allow the catheter sleeve 3351 to bend further to correspond to the shape of the tube 3350 (e.g., when worn by a patient).

[0389] In some forms, the catheter sleeve 3351 may include a first or upper opening 3352. The upper opening 3352 may be provided at one end of the catheter sleeve 3351. The upper opening 3352 may be an opening of a channel that extends along at least a portion of the catheter sleeve 3351.

[0390] As Figure 4G shown, some forms of the catheter sleeve 3351 may also include a lower extension 3354. The lower extension 3354 may be positioned at the end of the catheter sleeve 3351 opposite the upper opening 3352. The catheter sleeve 3351 may be customized to fit the face of a particular user. For example, the lower extension 3354 of the catheter sleeve 3351 may be constructed in a relatively more posterior or anterior region of the patient's head.

[0391] Some forms of the lower extension 3354 may include a rigid or semi-rigid member (e.g., within the catheter sleeve 3351). The rigid or semi-rigid member may be composed of a plastic material or a similar material. Alternatively, the lower extension 33543354 may be hardened using a manufacturing process (e.g., stitching hardening lines, flat knitting, using a thicker material).

[0392] As Figure 4G shown, some forms of the lower extension 3354 may include a connecting member 3356. In the illustrated example, the connecting member 3356 may be a magnet, although in other instances, the connecting member 3356 may be a different type of connector (e.g., mechanical fastener, adhesive, hook and loop material, etc.). The connecting member 3356 may also be positioned at one end of the lower extension 3354, although the connecting member 3356 may be positioned anywhere along the lower extension 3354.

[0393] In some forms, the connecting member 3356 (e.g., a magnet) may be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the catheter sleeve 3351 is connected to the tube 3350 (see, for example, Figure 4J ), the magnet 3370-1 connected to the lower band 3304-1 may be removably connected to the connecting member 3356 to provide tension.

[0394] 5.3.5.2.1 Four-point arm sleeve

[0395] As Figure 4HAs shown, another example of a sleeve is the four-point arm sleeve 3380, which can be used with the rigid arm 3340 described above.

[0396] As Figure 4H shown, the four-point arm sleeve 3380 can include a curved shape similar to the shape of the rigid arm 3340 as Figure 4D shown. The flexible material used to construct the four-point arm sleeve 3380 can allow the four-point arm sleeve 3380 to bend further to correspond to the shape of the rigid arm 3340 (e.g., when worn by a patient and / or bent by a patient).

[0397] As Figure 4H shown, some forms of the four-point arm sleeve 3380 can include a lower extension 3384. The lower extension 3384 can be located at one end of the four-point arm sleeve 3380.

[0398] In the example shown, the shape and / or structure of the lower extension 3384 is substantially the same as the shape of the lower extension 3354. For example, the lower extension 3384 can be more rigid compared to the rest of the four-point arm sleeve 3380 (e.g., due to threading or hardening of the rigid material).

[0399] As Figure 4H shown, some forms of the lower extension 3384 can include a connecting member 3386. In the example shown, the connecting member 3386 can be a magnet, although in other examples, the connecting member 3386 can be a different type of connector (e.g., a mechanical fastener, an adhesive, hook-and-loop material, etc.). The connecting member 3386 can also be located at one end of the lower extension 3384, although the connecting member 3386 can be located anywhere along the lower extension 3384.

[0400] In some forms, the connecting member 3386 (e.g., a magnet) can removably connect to the magnet 3370-1 of the headgear 3302-1. For example, when the four-point arm sleeve 3380 is connected to the rigid arm 3340 (see, for example Figure 4K ), the magnet 3370-1 connected to the lower band 3304-1 can removably connect to the connecting member 3386 in order to provide tension.

[0401] As Figure 4H shown, the four-point arm sleeve 3380 can include a pair of tabs 3394, which can be similar to the tabs 3320 on the tube 3350. When a patient wears the four-point arm sleeve 3380, the tabs 3394 can be located on the patient's head at substantially the same position as the tabs 3320 are located when the patient wears the tube 3350.

[0402] 5.3.5.2.2 Two-point arm sleeve

[0403] As Figure 4IAs shown, another example of a sleeve is the two-point arm sleeve 3380-1, which can be used with the rigid arm 3340 described above.

[0404] In some forms, the two-point arm sleeve 3380-1 can be similar to the four-point arm sleeve 3380 described above. Only some similarities and differences will be described below.

[0405] As Figure 4I shown, the two-point arm sleeve 3380-1 can include a lower opening 3388-1 located at the end of the two-point arm sleeve 3380-1. The lower opening 3388-1 can form an opening of a passage through the two-point arm sleeve 3380-1. In the example shown, the lower opening 3388-1 can lead to the surface of the conduit sleeve 3380-1.

[0406] As Figure 4I shown, the two-point arm sleeve 3380-1 can include a pair of tabs 3394-1, which can be similar to the tabs 3320 on the tube 3350. When the patient wears the two-point arm sleeve 3380-1, the tabs 3394-1 can be positioned on the patient's head at substantially the same position as the tabs 3320 are positioned when the patient wears the tube 3350.

[0407] 5.3.5.3 Assembled Patient Interface

[0408] As Figures 4J to 4M shown, the various elements described above can be combined into four different patient interfaces. Different patient interfaces can allow patients to use different types based on their respective comfort levels. The modularity of the different elements (e.g., the ability to use for multiple types of patient interfaces) can simplify manufacturing and / or can allow patients to more easily switch between multiple types of patient interfaces.

[0409] 5.3.5.3.1 Tube-on-Oral-Nasal Mask Configuration

[0410] As Figure 4J shown in, the patient can wear the cushion 3050-1 in a tubular structure having the tube 3350 and the four-point headgear 3302-1. This assembly can form a tubular oral-nasal patient interface 3000-1.

[0411] In some forms, a conduit sleeve can be used with the tube 3350 to enable the patient to experience an "upper tube" air delivery mode with oral and nasal cushions 3050-1. As described below, the conduit sleeve provides additional connection locations for connecting the four-point headgear 3302-1. However, other forms of connectors can be used in addition to or instead of the conduit sleeve.

[0412] In the illustrated example, the catheter sleeve can be connected to the tube 3350 of the positioning and stabilization structure 3300. The tube 3350 (via the catheter connection structure 3500) can be used to connect the tube 3350 to the gasket 3050-1. The catheter sleeve provides a magnet for connection to the magnet 3370-1 of the four-point headgear 3302-1 (see, for example Figure 4E ). Alternatively, different forms of connection can be used.

[0413] As Figure 4J shown, the four-point headgear 3302-1 can be connected at four separate locations to provide the tension to hold the gasket 3050-1 in a sealed position on the patient's head.

[0414] For example, the lower band 3304-1 (e.g., via the magnetic member 3306-1) can be removably connected to the magnet of the catheter sleeve. In use, each lower band 3304-1 can contact the patient's cheek (e.g., covering the masseter muscle). The lower band 3304-1 can also extend below the patient's ear.

[0415] 5.3.5.3.2 Configuration of the lower tube of the oro-nasal mask

[0416] As Figure 4K shown, the patient can wear the gasket 3050-1 in a downward tube structure having a rigid arm 3340 and a four-point headgear 3302-1. This assembly can form a downward oro-nasal patient interface 3000-2.

[0417] In some forms, the catheter sleeve can be used with the rigid arm 3340 to enable the patient to experience the "downward tube" air delivery mode of the oral and nasal gaskets 3050-1. As described below, the catheter sleeve provides additional connection locations for connecting the four-point headgear 3302-1. However, other forms of connectors can be used in addition to or instead of the catheter sleeve.

[0418] In the illustrated example, the catheter sleeve can be connected to the rigid arm 3340 of the positioning and stabilization structure 3300. The rigid arm 3340 (via the catheter connection structure 3504) can be used to connect the rigid arm 3340 to the gasket 3050-1. The catheter sleeve provides a magnet for connection to the magnet 3370-1 of the four-point headgear 3302-1 (see, for example Figure 4E ). Alternatively, different forms of connection can be used.

[0419] As Figure 4K shown, the four-point headgear 3302-1 can be connected at four separate locations to provide the tension to hold the gasket 3050-1 in a sealed position on the patient's head.

[0420] For example, the lower strap 3304-1 (e.g., via the magnetic member 3306-1) can be removably attached to the magnet of the catheter sleeve. In use, each lower strap 3304-1 can contact the patient's cheek (e.g., covering the masseter muscle). The lower strap 3304-1 can also extend under the patient's ear.

[0421] 5.3.5.3.3 Nasal mask upper tube configuration

[0422] As Figure 4L shown, the patient can wear the cushion 3050-2 in the upper tube configuration with the tube 3350 and the two-point headgear 3302-2. This assembly can form only the upper tube nasal-type patient interface 3000-3.

[0423] The catheter sleeve can be used with the tube 3350 and can provide additional comfort to the patient. The sleeve can connect to the positioning and stabilizing structure 3300 on the cushion 3050-2 without adding additional connection points. In the shown example, the tube 3350 of the positioning and stabilizing structure 3300 can be directly connected to the cushion 3050-2.

[0424] As Figure 4L shown, the two-point headgear 3302-2 can be connected to the tab 3320 on the tube 3350 to provide the tension to hold the cushion 3050-2 in the sealed position on the patient's head.

[0425] 5.3.5.3.4 Nasal mask lower tube configuration

[0426] As Figure 4M shown, the patient can wear the cushion 3050-2 in the upper tube configuration with the rigid arm 3340 and the two-point headgear 3302-2. This assembly can form only the lower tube nasal-type patient interface 3000-4.

[0427] The catheter sleeve can be used with the rigid arm 3340 and can provide additional comfort to the patient. The sleeve can connect to the positioning and stabilizing structure 3300 on the cushion 3050-2 without adding additional connection points. In the shown example, the rigid arm 3340 of the positioning and stabilizing structure 3300 can be directly connected to the cushion 3050-2.

[0428] As Figure 4M shown, the two-point headgear 3302-2 can be connected to the tab 3320 on the sleeve to provide the tension to hold the cushion 3050-2 in the sealed position on the patient's head.

[0429] 5.3.5.3.5 Component modularity

[0430] Figure 4PIllustrates how different components can be combined to form the four different patient interfaces described above. As shown, different components can be reused for different types of patient interfaces. This can allow for easier manufacturing and assembly, as a large number of identical components can be produced and used in multiple styles. The only component not used in multiple styles may be the sleeve. However, the sleeve can be more easily manufactured. Figure 4O Shows a portion of the air circuit 4170 of the air circuit 4170, while Figure 4N Shows that the ventilation housing 3404 of the air circuit shown can be interchangeably replaced according to the type of patient interface Figure 4O in.

[0431] 5.4 RPT Device

[0432] As Figures 3A to 3C shown, the RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electronic components and is configured to execute one or more algorithms 4300, such as any of the methods described in whole or in part herein. The RPT device 4000 can be configured to generate an air flow for delivery to a patient airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0433] 5.4.1 Air Filter

[0434] The RPT device according to one form of the present technology may include an air filter 4110 or a plurality of air filters 4110.

[0435] In Figure 3A one form shown, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0436] In Figure 3A one form shown, the outlet air filter 4114, such as an antibacterial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.

[0437] 5.4.2 Muffler

[0438] The RPT device according to one form of the present technology may include a muffler 4120 or a plurality of mufflers 4120.

[0439] In one form of the present technology (e.g., see Figure 4B ), the inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0440] 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.

[0441] 5.4.3 Pressure generator

[0442] In one form of the present technology, the pressure generator 4140 for generating a positive pressure air flow or air supply is a controllable blower 4142.

[0443] The pressure generator 4140 can be under the control of the therapy device controller 4240.

[0444] In other forms, the pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high-pressure source (such as a compressed air reservoir), or a bellows.

[0445] 5.4.4 Sensors

[0446] The transducer can be inside or outside the RPT device. The external transducer can be located, for example, on an air circuit (such as a patient interface) or form part of an air circuit. The external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or conveys data to the RPT device.

[0447] In one form of the present technology (see, for example Figure 4B ), one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. One or more transducers 4270 can be constructed and arranged to generate signals representing the characteristics of the air flow, such as the flow rate, pressure, or temperature at that point in the pneumatic path.

[0448] In one form of the present technology, one or more transducers 4270 can be located near the patient interface 3000 or 3800.

[0449] In one form, the signals from the transducer 4270 can be filtered, such as by low-pass filtering, high-pass filtering, or band-pass filtering.

[0450] 5.4.5 RPT sensors

[0451] 5.4.5.1 Flow sensor

[0452] The flow sensor 4274 according to the present technology can be based on a differential pressure transducer, such as the SDP600 series differential pressure transducers from SENSIRION of Switzerland.

[0453] In one form, the signal generated by the flow sensor 4274 and representing the flow rate is received by the central controller 4230.

[0454] 5.4.5.2 Pressure sensor

[0455] The pressure sensor 4272 according to the present technology is positioned in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a transducer from the Honeywell ASDX series. An alternative suitable pressure sensor is a transducer from the General Electric NPA series.

[0456] In one form, a signal generated by the pressure sensor 4272 and representing pressure is received by the central controller 4230.

[0457] 5.4.6 Motor speed transducer

[0458] In one form of the present technology, a motor speed transducer 4276 is used to determine the rotational speed of the motor 4144 and / or the blower 4142. A motor speed signal from the motor speed transducer 4276 can be provided to the therapy device controller 4240. The motor speed transducer 4276 can be, for example, a speed sensor such as a Hall effect sensor.

[0459] 5.4.7 Anti-backflow valve

[0460] As Figure 3A shown, in one form of the present technology, an anti-backflow valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000, for example, towards the motor 4144.

[0461] 5.4.8 RPT device electronics

[0462] 5.4.8.1 Power supply

[0463] The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.

[0464] In one form of the present technology, the power supply 4210 only supplies power to the RPT device 4000. In another form of the present technology, the power supply 4210 supplies power to both the RPT device 4000 and the humidifier 5000.

[0465] 5.4.8.2 Input device

[0466] In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow a person to interact with the device. The buttons, switches, or dials can be physical devices or software devices accessible via a touch screen. In one form, the buttons, switches, or dials can be physically connected to the outer housing 4010, or in another form, can communicate wirelessly with a receiver electrically connected to the central controller 4230.

[0467] In one form, input device 4220 may be constructed or arranged to allow a person to select values and / or menu options.

[0468] 5.4.8.3 Central Controller

[0469] In one form of the present technology, the central controller 4230 is a processor or multiple processors adapted to control the RPT device 4000. The central controller 4230 may be a processor or multiple processors adapted to control the RPT device 4000. Figure 3B shown.

[0470] Suitable processors may include x86 Intel processors, A processor of a processor, such as the STM32 series microcontroller from STMicroelectronics. In some alternative forms of the present technology, a 32-bit RISC CPU, such as the STR9 series microcontroller from STMicroelectronics, or a 16-bit RISC CPU, such as a processor from the MSP430 family microcontroller manufactured by Texas Instruments, may also be suitable.

[0471] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0472] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0473] The central controller 4230 may be configured to receive input signals from one or more transducers 4270 , one or more input devices 4220 , and the humidifier 5000 .

[0474] The central controller 4230 may be configured to provide output signals to one or more of the output device 4290 , the treatment device controller 4240 , the data communication interface 4280 , and the humidifier 5000 .

[0475] In some forms of the present technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 that can be implemented with processor control instructions, which are represented as computer programs stored in a non-transitory computer-readable storage medium (such as the memory 4260). In some forms of the present technology, the central controller 4230 can be integrated with the RPT device 4000. However, in some forms of the present technology, some methods can be executed by a remotely located device. For example, the remotely located device can analyze and determine the control setting values of the ventilator or detect respiration-related events by comparing stored data from any of the sensors described herein.

[0476] 5.4.8.4 Clock

[0477] The RPT device 4000 can include a clock 4232 connected to the central controller 4230.

[0478] 5.4.8.5 Treatment Device Controller

[0479] In one form of the present technology, the treatment device controller 4240 is the treatment control module 4330, which forms part of the algorithm 4300 executed by the central controller 4230.

[0480] In one form of the present technology, the treatment device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, the MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0481] 5.4.8.6 Protection Circuit

[0482] One or more protection circuits 4250 according to the present technology can include an electronic protection circuit, a temperature and / or pressure safety circuit.

[0483] 5.4.8.7 Memory

[0484] In one form according to the present technology, the RPT device 4000 includes a memory 4260, such as a non-volatile memory. In some forms, the memory 4260 can include a battery-powered static RAM. In some forms, the memory 4260 can include a volatile RAM.

[0485] The memory 4260 can be located on the PCBA 4202. The memory 4260 can be in the form of an EEPROM or a NAND flash memory.

[0486] Additionally or alternatively, the RPT device 4000 includes a removable form of memory 4260, such as a memory card manufactured according to the Secure Digital (SD) standard.

[0487] In one form of the present technology, the memory 4260 serves as a non-transitory computer-readable storage medium having computer program instructions stored thereon representing one or more methods described herein, such as one or more algorithms 4300.

[0488] 5.4.8.8 Data communication system

[0489] In one form of the present technology, a data communication interface 4280 is provided and is connected to the central controller 4230 (see Figure 3B ). The data communication interface 4280 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.

[0490] 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 can include an integrated circuit or a processor.

[0491] In one form, the remote external communication network 4282 is the Internet. The data communication interface 4280 can use wired communication (e.g., via Ethernet or fiber optic) or a wireless protocol (e.g., CDMA, GSM, LTE) to connect to the Internet.

[0492] In one form, the local external communication network 4284 utilizes one or more communication standards, such as Bluetooth or the Consumer Infrared Protocol.

[0493] In one form, the remote external device 4286 is one or more computers, such as a cluster of networked computers. In one form, the remote external device 4286 can be a virtual computer rather than a physical computer. In either case, this remote external device 4286 can be accessed by a duly authorized person (such as a clinician).

[0494] The local external device 4288 can be a personal computer, a mobile phone, a tablet, or a remote control.

[0495] 5.4.8.9 Output device including an optional display, siren

[0496] The output device 4290 according to the present technology can take the form of one or more of a visual, audio, and tactile unit. The visual display can be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0497] 5.4.8.9.1 Display driver

[0498] The display driver 4292 receives characters, symbols, or images as input for display on the display 4294 and converts them into commands that cause the display 4294 to display those characters, symbols, or images.

[0499] 5.4.8.9.2 Display

[0500] The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 can be an eight-segment display, in which case the display driver 4292 converts each character or symbol (such as the digit "0") into eight logic signals that indicate whether the eight corresponding segments are to be activated to display a particular character or symbol.

[0501] Now referring Figures 3A to 3C , in some forms of the present technology, the central controller 4230 can be configured to implement one or more algorithms 4300 represented as a computer program stored in a non-transitory computer-readable storage medium, such as the memory 4260. The algorithms 4300 are generally grouped into sets called modules.

[0502] In other forms of the present technology, some or all of the algorithms 4300 can be implemented by a controller of an external device, such as a local external device 4288 or a remote external device 4286. In such forms, the input signals and / or data representing intermediate algorithm outputs required for the portions of the algorithms 4300 to be executed at the external device can be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In such forms, the portions of the algorithms 4300 to be executed at the external device can be represented as a computer program, such as having processor control instructions to be executed by one or more processors, stored in a non-transitory computer-readable storage medium accessible by the controller of the external device. Such a program configures the controller of the external device to execute the portions of the algorithms 4300.

[0503] In such forms, treatment parameters generated by the external device via the treatment engine module 4320 (if such forms a part of the portions of the algorithms 4300 to be executed by the external device) can be transmitted to the central controller 4230 for delivery to the treatment control module 4330.

[0504] 5.4.8.10 Preprocessing Module

[0505] The preprocessing module 4310 according to one form of the present technology receives signals from the transducer 4270 (such as the flow rate sensor 4274 or the pressure sensor 4272) as input and performs one or more processing steps to calculate one or more output values that will be used as input to another module (such as the treatment engine module 4320).

[0506] In one form of the present technology, the output values include the interface pressure Pm, the ventilation flow rate Qv, the respiratory flow rate Qr, and the leakage flow rate Ql.

[0507] In various implementations of the present technology, the preprocessing module 4310 includes one or more of the following algorithms: an interface pressure estimation algorithm 4312, a ventilation flow rate estimation algorithm 4314, a leakage flow rate estimation algorithm 4316, and a respiratory flow rate estimation algorithm 4318.

[0508] 5.4.8.10.1 Interface Pressure Estimation

[0509] In one form of the present technology, the interface pressure estimation algorithm 4312 receives as inputs a signal from the pressure sensor 4272 representing the pressure (device pressure Pd) in the pneumatic path near the outlet of the pneumatic block and a signal from the flow rate sensor 4274 representing the flow rate (device flow rate Qd) of the air flow leaving the RPT device 4000. The device flow rate Qd without any supplementary gas 4180 can be used as the total flow rate Qt. The interface pressure estimation algorithm 4312 estimates the pressure drop ΔP across the air circuit 4170. The dependence of the pressure drop ΔP on the total flow rate Qt can be modeled for a specific air circuit 4170 by the pressure drop characteristic ΔP(Q). Then the interface pressure estimation algorithm 4312 provides the estimated pressure Pm in the patient interface 3000 or 3800 as an output. The pressure Pm in the patient interface 3000 or 3800 can be estimated as the device pressure Pd minus the air circuit pressure drop ΔP.

[0510] 5.4.8.10.2 Ventilation Flow Rate Estimation

[0511] In one form of the present technology, the ventilation flow rate estimation algorithm 4314 receives as an input the estimated pressure Pm in the patient interface 3000 or 3800 from the interface pressure estimation algorithm 4312, and estimates the ventilation flow rate Qv of air from the ventilation 3400 in the patient interface 3000 or 3800. For a specific ventilation 3400 in use, the dependence of the ventilation flow rate Qv on the interface pressure Pm can be modeled by the ventilation characteristic Qv(Pm).

[0512] 5.4.8.10.3 Leakage Flow Rate Estimation

[0513] In one form of the present technology, the leakage flow rate estimation algorithm 4316 receives the total flow rate Qt and the ventilation flow rate Qv as inputs, and provides an estimate of the leakage flow rate Ql as an output. In one form, the leakage flow rate estimation algorithm estimates the leakage flow rate Ql by calculating the average value of the difference between the total flow rate Qt and the ventilation flow rate Qv over a sufficiently long time period (e.g., about 10 seconds).

[0514] In one form, the leak flow estimation algorithm 4316 receives the total flow Qt, the ventilation flow Qv, and the estimated pressure Pm in the patient interface 3000 or 3800 as inputs, and provides the leak flow Ql as an output by calculating the leak conductance and determining the leak flow Ql as a function of the leak conductance and the pressure Pm. The leak conductance is calculated as the quotient of the low-pass filtered non-ventilation flow equal to the difference between the total flow Qt and the ventilation flow Qv and the square root of the low-pass filtered pressure Pm, where the low-pass filter time constant has a value long enough to include several respiratory cycles, such as about 10 seconds. The leak flow Ql can be estimated as the product of the leak conductance and the pressure function Pm.

[0515] 5.4.8.10.4 Respiratory Flow Rate Estimation

[0516] In one form of the present technology, the respiratory flow estimation algorithm 4318 receives the total flow Qt, the ventilation flow Qv, and the leak flow Ql as inputs, and estimates the respiratory flow Qr of the air to the patient by subtracting the ventilation flow Qv and the leak flow Ql from the total flow Qt.

[0517] 5.4.8.11 Treatment Engine Module

[0518] In one form of the present technology, the treatment engine module 4320 receives one or more of the pressure Pm in the patient interface 3000 or 3800 and the respiratory flow Qr of the air to the patient as inputs, and provides one or more treatment parameters as outputs.

[0519] In one form of the present technology, the treatment parameter is the treatment pressure Pt.

[0520] In one form of the present technology, the treatment parameter is one or more of the pressure change amplitude, the base pressure, and the target ventilation volume.

[0521] In various forms, the treatment engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation volume determination 4323, inspiratory flow limit determination 4324, apnea / hypopnea determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation volume determination 4328, and treatment parameter determination 4329.

[0522] 5.4.8.11.1 Phase Determination

[0523] In one form of the present technology, the RPT device 4000 does not determine the phase.

[0524] In one form of the present technology, the phase determination algorithm 4321 receives a signal indicating the respiratory flow Qr as an input, and provides the phase of the current respiratory cycle of the patient 1000 as an output.

[0525] 5.4.8.11.2 Waveform determination

[0526] In one form of the present technology, the treatment parameter determination algorithm 4329 provides an approximately constant treatment pressure throughout the patient's respiratory cycle.

[0527] In other forms of the present technology, the treatment control module 4330 controls the pressure generator 4140 to provide a treatment pressure Pt that varies as a function of the phase Φ of the patient's respiratory cycle according to the waveform template Π(Φ).

[0528] In one form of the present technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ) of values in the range [0, 1] on the phase value Φ domain provided by the phase determination algorithm 4321 for use by the treatment parameter determination algorithm 4329.

[0529] 5.4.8.11.3 Tidal volume determination

[0530] In one form of the present technology, the ventilation determination algorithm 4323 receives an input of the respiratory flow rate Qr and determines a measurement indicative of the current patient ventilation Vent.

[0531] 5.4.8.11.4 Inspiratory flow limitation determination

[0532] In one form of the present technology, the central controller 4230 executes the inspiratory flow limitation determination algorithm 4324 to determine the degree of inspiratory flow limitation.

[0533] 5.4.8.11.5 Apnea and hypopnea determination

[0534] In one form of the present technology, the central controller 4230 executes the apnea / hypopnea determination algorithm 4325 to determine the presence of apnea and / or hypopnea.

[0535] 5.4.8.11.6 Snoring determination

[0536] In one form of the present technology, the central controller 4230 executes one or more snoring determination algorithms 4326 for determining the degree of snoring.

[0537] 5.4.8.11.7 Airway patency determination

[0538] In one form of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 for determining the degree of airway patency.

[0539] 5.4.8.11.8 Target tidal volume determination

[0540] In one form of the present technology, the central controller 4230 takes the measured value of the current ventilation volume Vent as an input and executes one or more target ventilation volume determination algorithms 4328 for determining the target value Vtgt of the ventilation volume measurement value.

[0541] 5.4.8.11.9 Determination of treatment parameters

[0542] In some forms of the present technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 for determining one or more treatment parameters using values returned by one or more other algorithms in the treatment engine module 4320.

[0543] 5.4.8.12 Treatment control module

[0544] The treatment control module 4330 according to one aspect of the present technology receives the treatment parameters from the treatment parameter determination algorithm 4329 of the treatment engine module 4320 as an input and controls the pressure generator 4140 to deliver an air flow according to the treatment parameters.

[0545] In one form of the present technology, the treatment parameter is the treatment pressure Pt, and the treatment control module 4330 controls the pressure generator 4140 to deliver an air flow such that the interface pressure Pm at the patient interface 3000 or 3800 is equal to the treatment pressure Pt.

[0546] 5.4.8.13 Detection of fault conditions

[0547] In one form of the present technology, the central controller 4230 executes one or more methods 4340 for detecting fault conditions. The fault conditions detected by the one or more methods 4340 may include at least one of the following:

[0548] · Power failure (no power or insufficient power)

[0549] · Sensor fault detection

[0550] · Failure to detect the presence of a component

[0551] · Operating parameters outside the recommended range (e.g., pressure, flow rate, temperature, PaO2)

[0552] · The test alarm fails to generate a detectable alarm signal.

[0553] When a fault condition is detected, the corresponding algorithm signals the presence of a fault through one or more of the following:

[0554] · Activating an audible, visual, and / or dynamic (e.g., vibration) alarm

[0555] · Sending a message to an external device

[0556] · Event record

[0557] 5.5 Patient interface detection

[0558] Figure 5A A schematic diagram of a respiratory therapy system 8000 is shown. The respiratory therapy system 8000 can be configured to wirelessly detect information about the patient interface 3000 or accessories used by a patient during a therapy session. In some aspects, a patient interface (or accessory) detection system can be created in conjunction with the techniques further described below, in which the patient does not need to manually scan or input (e.g., via an external device such as a smart phone, computer, or tablet, or via a mechanism within the respiratory therapy system) the type of patient interface being used. In other aspects, a wireless patient interface detection system can allow the respiratory therapy system 8000 to confirm the accuracy of patient input regarding the type of patient interface (or accessory) being used, or can track the use or other characteristics of the patient interface (or accessory) being used, as further described below.

[0559] The respiratory therapy system 8000 includes a patient interface 3000 and a respiratory pressure therapy (RPT) device 4000 fluidly coupled via an air circuit 4170, which can be a catheter or tube as described above. As described above, the RPT device 4000 is configured to supply an air flow to the patient interface 3000 via the air circuit 4170, e.g., air that can supplement oxygen. The RPT device 4000 can include any of the elements described above, such as a humidifier, an oxygen source, and / or a data management system.

[0560] The RPT device 4000 can be used alone or as part of the system 8000 to deliver one or more of the various therapies described above, e.g., by operating the device to generate an air flow for delivery to an interface (e.g., the patient interface 3000) to a user's airway. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Thus, the RPT device 4000 can also be used as a flow therapy device. The RPT device 4000 can include, for example, a CPAP device and / or a ventilator.

[0561] The respiratory therapy system 8000 may also include a radio frequency identification (RFID) system 9000. The RFID system 9000 may be configured, for example, to detect one or more characteristics of the respiratory therapy delivered from the RPT device 4000 to the patient interface 3000, the identification of the patient interface 3000, and / or the identification of an accessory device (not shown) directly or indirectly coupled to the respiratory therapy system 8000. Exemplary accessory devices may include, but are not limited to, patient interface headgear, cushions on the patient interface 3000, air filters, humidifiers, one or more components of a humidification system (e.g., components of a heat and moisture exchanger or a passive humidifier), conduits, and / or adapter accessories.

[0562] RFID is a form of wireless communication that combines the use of electromagnetic or electrostatic coupling in the radio frequency portion of the electromagnetic spectrum to, for example, uniquely identify and / or track an object. The RFID system 9000 may operate according to the principle of inductive coupling.

[0563] 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, as described in further detail herein, the RFID system 9000 includes two or more antennas 9100. The antenna 9100 is configured to transmit radio waves and receive reflected signals, for example, from the tag 9200. The antenna 9100 may be a linear antenna and thus may transmit a linearly polarized signal, or the antenna 9100 may be a circular antenna and thus may transmit a circularly polarized signal. In some embodiments, the RFID system 9000 may include a linear antenna and a circular antenna.

[0564] The antenna 9100 may be disposed within a proximal portion of the air circuit 4170 (e.g., near the patient interface 3000). For example, the antenna 9100 may be disposed within a portion of the air circuit 4170, such as within a cover 4172 on the proximal portion 4170A of the air circuit 4170, as Figure 6A and Figure 6B shown and will be described in further detail below. In alternative embodiments, the antenna 9100 may be disposed within the lumen 4178 of the air circuit 4170 (see Figure 6A and Figure 6B ). In additional alternative configurations, the antenna 9100 may be fixedly or removably coupled to the exterior of the air circuit 4170, such as on the outer surface of the air circuit 4170.

[0565] The tag 9200 is configured to emit radio waves to send information. The tag 9200 may include a microchip that stores and processes information, such as a unique identifier of the tag 9200, and an antenna 9100 to enable the tag 9200 to receive and / or transmit radio signals. The tag 9200 may be an active tag or a passive tag. If a passive tag is used, it may rely on the power of the antenna to send data and thus may have a shorter transmission range. For example, the tag 9200 may receive all the required energy from a magnetic field in which the tag 9200 operates.

[0566] The tag 9200 may be read-only, read / write, or write-once, read-many. The tag 9200 may be configured to include a patient interface 3000 and / or identification data of the patient. In some aspects, the tag 9200 may include information related to a use date or timestamp. The tag 9200 may additionally or alternatively include information related to the type of patient interface 3000 used, characteristics of the patient interface 3000 (e.g., pad material, pad size, catheter size, patient interface size, length of use of the patient interface, manufacturing date of the patient interface, one or more of a set of respiratory therapy conditions for which the patient interface is suitable for use with, etc.), a series identification number of the patient interface 3000, a production batch identification number of the patient interface 3000, and / or other aspects of the respiratory therapy system 8000. In some aspects, the tag 9200 may be configured to include patient information, such as the type of treatment or treatment settings that the patient desires to receive, or other information. The tag 9200 may also be used to detect the connection and / or disconnection of the air circuit 4170 and / or accessory devices (not shown).

[0567] In some embodiments, the tag 9200 may include an adhesive, for example to assist in applying the tag 9200 to the patient interface 3000 and / or in holding the tag 9200 in place on the patient interface 3000 after application. Optionally, the tag 9200 may be overmolded within a portion of the patient interface 3000. For example, the tag 9200 may be overmolded into a soft plastic material, such as a silicone pad, or into a hard plastic material, such as the plastic frame of the patient interface 3000. Alternatively, the tag 9200 may include conductive silicone and / or conductive bundles or inks (e.g., silver ink) printed on the soft and / or hard plastic material that makes up the patient interface 3000. The tag 9200 may include, for example, an overmolded inlay tag, a conductive fabric, or may be coupled to the patient interface 3000 by any suitable method used in the art.

[0568] The tag 9200 can be an RFID tag and, in some cases, a Near Field Communication (NFC) tag. The tag 9200 can be configured to generate an electromagnetic field having a frequency of approximately 10 MHz to approximately 12 GHz (e.g., approximately 13.56 megahertz (MHz)), and the antenna 9100 can be configured to read data transmitted from the tag 9200 at a frequency of approximately 10 MHz to approximately 12 GHz (e.g., approximately 13.56 MHz). In other aspects, the RFID system 9000 can alternatively be configured to generate an electromagnetic field having a frequency between approximately 30 kilohertz (kHz) and approximately 3 gigahertz (GHz). In some instances, the RFID system 9000 can be configured to operate in a low frequency range, or between approximately 30 kHz and 300 kHz. Thus, the RFID system 9000 can be configured to have a read range of up to approximately 10 centimeters (approx. 3.94 inches), although the exact distance can vary depending on, for example, the angles of the different components in the system relative to each other. Alternatively, the RFID system 9000 can be configured to operate in a high frequency range, or between approximately 3 MHz and 30 MHz. In this configuration, the RFID system 9000 can be configured to have a read range between approximately 10 centimeters and approximately one meter (approx. 3.94 inches to approx. 39.37 inches). Additionally, the RFID system 9000 can be configured to operate in an ultra-high frequency range, or between approximately 300 MHz and 3 GHz. In this configuration, the RFID system 9000 can be configured to have a read range between approximately one meter and approximately 12 meters. For example, the tag 9200 can be an Ultra-High Frequency (UHF) tag, a Bluetooth tag, or an Ultra-Wideband (UWB) tag. The tag 9200 and the antenna 9100 can be tuned to operate at the same frequency. The UWB tag 9200 can operate in a frequency range of approximately 3.1 GHz to approximately 10.6 GHz, the Bluetooth tag 9200 can operate at a frequency of approximately 2.4 GHz, and the UHF tag 9200 can operate in a frequency range of approximately 300 MHz to approximately 3 GHz.

[0569] In some instances, a shorter read range of the RFID system 9000 may be desirable. For example, if a patient is near multiple devices or objects containing RFID components, the RFID system 9000 may inadvertently read tags or antennas on peripheral devices. Thus, if the RFID system 9000 is configured to operate in a low frequency range, such as 13.56 MHz, the likelihood of the RFID system 9000 inadvertently reading peripheral devices is reduced.

[0570] The RFID system 9000 may include a single tag 9200 fixedly or removably coupled to the patient interface 3000 or an accessory device (not shown). Alternatively, the RFID system 9000 may include two or more tags 9200 fixedly coupled to the patient interface 3000 or an accessory device (not shown). The RFID tags 9200 described herein may be off-the-shelf components or may be customized according to the size and / or shape of the patient interface 3000 and / or according to the read range of the tags 9200. Although the tags 9200 are described herein as being associated with the patient interface 3000, the tags 9200 may alternatively or additionally be associated with, for example, the air circuit 4170 of the respiratory therapy system 8000 or another accessory. Insofar as the tags 9200 are associated with the air circuit 4170 or another accessory, the tags 9200 may include information about the accessory or air circuit with which they are associated.

[0571] The antenna 9100 is configured to receive data from the tag 9200 and transmit the received data to a transceiver or reader 9300. For different types of patient interfaces 3000, the antenna 9100 may be set to the same inductance as the tag 9200 such that the antenna 9100 can be compatible with a variety of patient interfaces 3000. The transceiver 9300 may be operably connected to the antenna 9100 physically (e.g., via a wire) and may be located above or within the air circuit 4170 or the adapter 9400. In one configuration, the transceiver 9300 may be located on or in 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, a smart phone, a tablet computer, or any other device configured to receive RFID signals transmitted from an RFID tag or antenna. Thus, the antenna 9100 is configured to transfer data received from the tag 9200 to the transceiver 9300. The transceiver 9300 may also be configured to save or store the data transmitted from the antenna 9100.

[0572] Still referring to Figure 5A, the transceiver 9300 may include a controller on a flexible circuit, for example, connected within the air circuit 4170. The transceiver 9300 may relay information from the antenna 9100 to a controller configured to control the RPT device 4000. The controller may be separate from the RPT device 4000 or may be part of the RPT device 4000. The controller may operate as described above. The transceiver 9300 may generate an electromagnetic field having an appropriate frequency (e.g., 13.56 MHz) and may be configured to read the tag 9200 from the patient interface 3000 or an accessory coupled at the patient interface 3000. The accessory may include, but is not limited to, for example, one or more of a headgear, a gasket, a heat and moisture exchanger or a waterless humidifier, an air filter, an air conduit, or an adapter of the patient interface, as described above.

[0573] In some configurations, the transceiver 9300 may be configured to physically (e.g., via a wire) or wirelessly transmit data to the RPT device 4000. The RPT device 4000 may also be configured to save or store the data sent from the transceiver 9300, interpret the sent data, and / or send an alert or signal to a user or a care provider, as described above. In some embodiments, the RPT device 4000 may also be configured to automatically change one or more characteristics of the respiratory pressure therapy, for example, based on the raw data and / or the interpreted data received from the transceiver 9300. Additionally or alternatively, the RPT device 4000 may be configured to suggest one or more treatment settings, for example, to facilitate patient care and / or patient comfort based on the interpreted data from the transceiver 9300, as will be further discussed below.

[0574] Figure 5B An alternative configuration of the respiratory therapy system 8000′ is shown. The respiratory therapy system 8000′ may include any features discussed above with respect to the respiratory therapy system 8000, except as described below. For example, the respiratory therapy system 8000′ includes a patient interface 3000 and a respiratory pressure therapy (RPT) device 4000 fluidly coupled by an air circuit 4170. The respiratory therapy system 8000′ also includes an RFID system 9000'.

[0575] Similar to the RFID system 9000 discussed above with respect to Figure 5A the RFID system 9000 includes a tag 9200, an antenna 9100, and a transceiver 9300. In comparison, in Figure 5BIn the configuration shown, an adapter 9400 is configured to be fixedly or removably coupled between the air circuit 4170 and the patient interface 3000. The adapter 9400 may include or incorporate an antenna 9100. Thus, the adapter 9400 and the antenna 9100 may be, for example, separate components independent of the air circuit 4170 and the patient interface 3000. In this way, the adapter 9400 may be used in combination with various air circuits 4170, or may be used to improve an air circuit 4170 that does not have an antenna 9100. In some aspects, the adapter 9400 may be reusable, and the air circuit 4170 may be replaceable. Figure 5B The antenna shown may have any or all of the characteristics of the antenna 9100, as referenced above Figure 5A described. In some aspects of the present technology, the adapter 9400 may also include one or more sensors.

[0576] The techniques described use various types of sensors. Any one or all of these sensors may be configured to generate a signal based on, indicative of, or reflective of one or more physical phenomena. Illustrative examples of sensor types (and sensed physical phenomena) include humidity, temperature, air flow, pressure, light, particles, biochemical, acceleration, angular velocity, etc. Other types of sensors are also discussed herein and may be used in conjunction with the techniques described herein. Any or all of the sensors described herein may transmit a signal based on the sensed physical phenomena via wired communication and / or via wireless communication. Any or all of the sensors discussed herein may be included as part of the 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 at different locations associated with the exemplary respiratory therapy system and its components. For example, a first sensor may be located in the RPT device, another in the patient interface, and another in the air conduit. Other examples of where one or more sensors may be located are described herein.

[0577] The adapter 9400 can be in fluid communication with the air circuit 4170 and the patient interface 3000. In this way, the adapter 9400 can include a lumen having a proximal opening and a distal opening. The lumen is configured to allow air to flow from the air circuit 4170 through the adapter 9400 into the patient interface 3000. Additionally, the adapter 9400 forms a fluid seal between the air circuit 4170 and the patient interface 3000. To achieve a fluid-tight seal, in some configurations, the proximal portion of the air circuit 4170 can, for example, extend at least partially through the distal opening of the adapter 9400 into the distal portion of the adapter 9400. Alternatively, the distal portion of the adapter 9400 can extend at least partially into the proximal portion of the air circuit 4170. Similarly, the distal portion of the patient interface 3000 can extend at least partially into the proximal opening of the adapter 9400.

[0578] Figure 6A and Figure 6B A perspective view of the proximal portion 4170A of the air circuit 4170 is shown. For example, Figure 6A and 6B the air circuit 4170 shown can be used with Figure 5A and 5B the system 8000 or the system 8000' shown, respectively. The air circuit 4170 is a conduit or tube constructed and arranged to allow air flow to travel between two components of a respiratory therapy system (such as the RPT device 4000 and the patient interface 3000) in use. Although not shown, in some cases, the branches of the air circuit 4170 for inhalation and exhalation can be separate. In other cases, the air circuit 4170 can be single-limb and used for both inhalation and exhalation.

[0579] The proximal portion 4170A of the air circuit 4170 can include a proximal-most end that includes a cap 4172. The cap 4172 can be directly or indirectly coupled to the proximal portion 4170A of the air circuit 4170. The cap 4172 can include one or more features 4174 that extend outwardly from the proximal surface 4172A of the cap 4172. The (one or more) features 4174 can be configured to facilitate a secure and / or fluid-tight connection, for example, between the air circuit 4170 and the patient interface 3000 (as Figure 5A shown) or between the air circuit 4170 and the adapter 9400 (as Figure 5Bas shown). For example, feature 4174 may include a bayonet connector that includes a protrusion and / or a recess that is configured to engage a corresponding protrusion and / or recess on the patient interface / adapter by rotating the connector until it latches. In an alternative example, feature 4174 may include a heteroconic shape that is configured to connect to the patient interface / adapter. However, it should be understood that feature 4174 may include other suitable configurations (e.g., a releasable snap-fit connector) to facilitate connection to the patient interface / adapter.

[0580] Cover 4172 also includes an opening 4176. Opening 4176 extends through the entire cover 4172 and is in fluid communication with the lumen 4178 of the air circuit 4170. The cover 4172 and / or the inner surface defining the lumen 4178 of the air circuit 4170 may include one or more protrusions or projections 4190. Projections 4190 may, for example, extend radially inwardly into the lumen 4178 from the inner surface defining the lumen 4178 and / or from the inner surface 4179 of the cover 4172. Projections 4190 may extend partially or fully through the lumen 4178. As described below, with reference Figure 6B , projections 4190 may include an encapsulation 4199 or may cooperate with an encapsulation 4199. Although not shown, projections 4190 may include one or more sensors. The sensors 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, projections 4190 may include sensors to identify the temperature, humidity level, air flow, pressure, etc. of the fluid within the air circuit 4170. The sensors may communicate with the RPT device 4000, the antenna 9100, and / or the transceiver 9300.

[0581] Figure 6B shows a proximal portion 4170A of one version of the air circuit 4170 with the cover 4172 removed. A 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 that extends proximally from the nearest surface 4170B of the air circuit 4170. Although not shown, the protrusion 4170C may include one or more features (e.g., one or more notches, one or more projections, etc.) to assist in supporting and / or restraining 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 notch, a projection) that couples the proximal portion 4192A of the circuit board 4192 to the protrusion 4170C and / or a second feature (e.g., a notch, a projection) that couples the distal portion 4192B of the circuit board 4192 to the protrusion 4170C.

[0582] The surface 4195 of the circuit board 4192 that defines the platform 4196 is configured to face proximally. For example, the surface 4195 is configured to be in a plane that is generally perpendicular to an axis A that longitudinally extends from the proximal end to the distal end of the air circuit 4170. In this way, the platform 4196 is bent relative to the circuit board 4192 by approximately 90 degrees. The platform 4196 is coupled to the circuit board 4192 by a bridge 4194. The platform 4196 also includes an antenna 4100. The antenna 4100 can have any or all of the characteristics of the antenna 9100 described above with reference to Figure 5A and Figure 5B The platform 4196 includes an opening 4198 that extends through the entire platform 4196. The opening 4198 can be configured to allow fluid to flow through the lumen 4178 of the air circuit 4170. Thus, the opening 4198 can have the same diameter or a different diameter as the lumen 4178 of the air circuit 4170. Although the cover 4172 is removed from Figure 6B to show this exemplary arrangement of the antenna 4100 incorporated into the air circuit 4170, during use, the cover 4172 will obscure the antenna 4100, as Figure 6A shown.

[0583] The enclosure 4199 can house one or more sensors, such as those discussed above (e.g., the sensors in the protrusion 4190). In some instances, the enclosure 4199 can be formed by additive manufacturing techniques (e.g., 3D printing). The enclosure 4199 can be formed of any suitable material, such as a transparent material, such as silicone. The enclosure 4199 can enclose and seal the sensors and hold the sensors in place. In an alternative, a single enclosure 4199 can encapsulate multiple sensors. In a further alternative, the proximal portion 4170A can include multiple enclosures 4199, each for encapsulating one or more sensors.

[0584] Figure 6C A front view of the circuit board 4192 in a first or flat configuration is shown. 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 fold around the protrusion 4170C of the air circuit 4170 (shown in Figure 6B ). Thus, the circuit board 4192 can be composed of one or more bendable or flexible materials.

[0585] The bridge 4194 is configured to provide a physical connection between the circuit board 4192 and the platform 4196. To enable the platform 4196 to bend by approximately 90 degrees, as Figure 6BAs shown, the bridge 4194 is formed of a bendable or flexible material. 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 to a greater extent and / or more easily. Additionally or alternatively, the bridge 4194 may be composed of the same material or a different material as the circuit board 4192 and / or the platform 4196. For example, the bridge 4194 may be composed of a material having more flexible characteristics compared to the circuit board 4192 and / or the platform 4196. When applied to the air circuit 4170, the opening 4198 of the platform 4196 may be coaxially positioned with the lumen 4178 of the air circuit 4170 such that the platform 4196 is located on the proximal end of the protrusion 4170C. The bridge 4194 may be bent relative to the platform 4196, and the circuit board 4192 may be bent to surround the protrusion 4170C, as Figure 6B shown.

[0586] The antenna 4100 is fixed to the platform 4196 and is electrically coupled to the circuit board 4192, for example, via the bridge 4194. The antenna 4100 surrounds or encircles the opening 4198. Thus, the antenna 4100 surrounds or encircles the proximal opening of the lumen 4178 of the air circuit 4170, as Figure 6B shown.

[0587] The antenna 4100 may be formed by various methods or combinations of methods. The antenna 4100 may include a flexible circuit directly connected to the main flexible circuit of the transceiver 9300, and the transceiver 9300 may be connected to the air circuit 4170. The antenna 4100 may be formed of one or more conductors, such as copper, soldered, brazed, glued, or otherwise fixed to the platform 4196 or around the periphery of the air circuit 4170. The wires may be fixed to the transceiver module of the circuit board. The antenna 4100 may be formed by directly applying a printed conductor (such as silver ink or a printed conductive bundle) onto the platform 4196 or around the periphery of the air circuit 4170. The antenna 4100 may be formed of a flexible printed circuit (FPC), coil wire, or conductive printing or plastic. Laser direct structuring (LDS) may be applied to a plastic housing that can protect electronic components. The LDS may be coupled, soldered, or brazed to a transceiver module, such as a circuit board. In this way, for example, the antenna 4100 may be directly implemented on the platform 4196.

[0588] The magnetic field strength of the passive tag 9200 is proportional to the distance between the passive tag 9200 and the antenna 9100. For example, when the tag 9200 moves away from the antenna 9100, the magnetic field strength of the passive RFID tag 9200 decreases. Conversely, when the tag 9200 moves closer to the antenna 9100, the magnetic field strength of the passive tag 9200 increases. This is because, as described above, the passive tags 9200 obtain the energy required to transmit radio waves from the magnetic field in which they operate. In other words, the passive tags 9200 and the antenna 9100 operate according to the principle of inductive coupling. Figure 5A and 5B The RFID system 9000 shown in operates under these conditions. Therefore, the placement of the antenna 9100 relative to the tag 9200 affects the operability of the RFID system 9000 within the system 8000.

[0589] As previously discussed, the tag 9200 can be fixedly or removably coupled to the patient interface 3000, for example, near where the air circuit 4170 is coupled to the patient interface 3000. The distance between the antenna 9100 and the tag 9200 can vary depending on the type or size of the patient interface 3000 used by the patient. As Figures 4J to 4P shown, as described above, the patient interface 3000 can have various different configurations and various components. The type or position of the custom tag 9200 can be designed for different patient interfaces, for example, to fit the antenna 9100 or to place the tag 9200 within the appropriate reading direction or angle. The antenna 9100 and the tag 9200 can be positioned near where the air circuit 4170 is coupled to the patient interface 3000, and can be positioned to avoid contact with the patient's skin during use, or to avoid the ventilation contact area. The system 8000 described herein can be used with a variety of patient interface types, such as, for example, a nasal patient interface with an upper tube (e.g., having any of the characteristics of the patient interface 3000-3), a nasal patient interface with a lower tube (e.g., having any of the characteristics of the patient interface 3000-4), a full-face patient interface with an upper tube (e.g., having any of the characteristics of the patient interface 3000-1), or a full-face patient interface with a lower tube (e.g., Figure 4L any of the characteristics of the patient interface 3000-3), a nasal patient interface with a lower tube (e.g., having any of the characteristics of the patient interface 3000-4), a full-face patient interface with an upper tube (e.g., having any of the characteristics of the patient interface 3000-1), or a full-face patient interface with a lower tube (e.g., Figure 4M any of the characteristics of the patient interface 3000-1), or a full-face patient interface with a lower tube (e.g., having any of the characteristics of the patient interface 3000-2). Figure 4J any of the characteristics of the patient interface 3000-1), or a full-face patient interface with a lower tube (e.g., Figure 4J any of the characteristics of the patient interface 3000-1), or a full-face patient interface with a lower tube (e.g., having any of the characteristics of the patient interface 3000-2). Figure 4K any of the characteristics of the patient interface 3000-2).

[0590] Figure 7A and Figure 7B depicts an exemplary patient interface 3000'. For example, the patient interface 3000' can be used, respectively, as described above with respect to Figure 5A and Figure 5BThe patient interface 3000 of the described system 8000 or system 8000'. 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 generally be referred to as a nasal patient interface or a full-face patient interface. For example, the patient interface 3000' may be configured to cover a patient's mouth and nose, or only the patient's nose.

[0591] Figure 7A and Figure 7B include stippling to better illustrate and describe various portions of the patient interface 3000' that will be described herein. However, the stippling is for purposes of description and does not necessarily indicate that different portions of the patient interface 3000' include different materials, properties, or colors, although in one instance, different portions may include different materials, properties, or colors.

[0592] The patient interface 3000' has a three-dimensional shape that may vary depending on the style or type of the patient interface. For example, the size and shape of the patient interface 3000' may be significantly different from Figure 7A and Figure 7B the size and shape shown. Portions of the patient interface 3000' may be formed of a rigid or hard material, while other portions of the patient interface 3000' may be formed of a soft or flexible material. Thus, the placement of an RFID tag (such as tag 9200) on the patient interface 3000' presents unique considerations.

[0593] The patient interface 3000' includes a housing 3002 having a first portion 3002A, a second portion 3002B, a third portion 3002C, and a fourth portion 3002D. One or more portions of the housing 3002 (e.g., the first portion 3002A, the second portion 3002B, and the third portion 3002C) may be formed of a rigid material (e.g., polycarbonate) and may not contact the patient's skin. One or more portions of the housing 3002 (e.g., the fourth portion 3002D) may be formed of a softer, more flexible material (e.g., silicone rubber). The first portion 3002A includes an opening 3008. The opening 3008 extends through the entire thickness of the housing 3002 and is configured to couple the patient interface 3000' directly or indirectly to a proximal portion of the air circuit 4170. The opening 3008 is aligned with the intermediate plane 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.

[0594] Because the antenna 9100 ( Figure 6B 、 6CThe 4100) can be disposed in or on the proximal portion of the air circuit 4170, and the proximal portion of the air circuit 4170 is coupled to the patient interface 3000' via the opening 3008, so the label 9200 can be positioned near the opening 3008 in the "lower tube" configuration of the patient interface 3000', as Figure 7A shown ( Figure 4K and 4M also describes a similar "lower tube" configuration where the label 9200 may have a similar position). For example, the label 9200 can be coupled to the first part 3002A, the second part 3002B, the third part 3002C, or the fourth part 3002D. In some aspects, due to the proximity of the opening 3008, the label 9200 can be placed on or near the third part 3002C, which can be an ideal location for the patient interface 3000'. The third part 3002C is close to or adjacent to the intermediate plane M. For example, the label 9200 can be placed on one side (i.e., the left or right side) defined by the intermediate plane M, or on the other side (i.e., the right or left side) defined by the intermediate plane M, or along the intermediate plane M. In some configurations, the label 9200 can be positioned to straddle multiple parts of the patient interface 3000'. For example, the first part of the label 9200 can be on the first part 3002A of the housing 3002, and the second part of the label 9200 can be on the second part 3002B and / or the third part 3002C of the housing 3002. In this way, the position of the label 9200 can vary between the first part 3002A, the second part 3002B, the third part 3002C, and / or the fourth part 3002D.

[0595] The label 9200 can be placed on or in the housing 3002 in various ways. For example, the label 9200 can be an overmolded chip into the housing 3002. Alternatively, the label 9200 can be directly printed on the housing 3002 with a printed conductive material such as silver ink. The label 9200 can be an inlay label overmolded into the housing 3002. In such an instance, the label 9200 (e.g., the inlay label) can be inserted, for example, via automation into the cavity of the mold for the housing 3002, and the injection mold and plastic can be injected over the inlay label, thereby fixing the inlay label within or on the housing 3002. Alternatively, the label 9200 can be formed by conductive silicone and / or conductive bundles printed on the housing 3002. In additional alternatives, the label 9200 can be formed by a conductive fabric having stretchable copper traces. Thus, the label 9200 can be formed by any one of these methods or any combination of these methods, including those known in the art. Additionally, the label 9200 can be a separate component fixed to the housing 3002 by various suitable means known in the art, including but not limited to adhesives and / or one or more mechanical fasteners.

[0596] The patient interface 3000' further includes a gasket 3006 configured to contact the patient's face. The gasket 3006 may be formed of a soft or flexible material, such as silicone rubber. The gasket 3006 is configured to form a seal against the patient's face. Although the tag 9200 may be placed on or within the gasket 3006, placing the tag 9200 on or within the gasket 3006 may be less desirable due to challenges associated with the distance of the gasket 3006 from the opening 3008 and / or challenges associated with one or more properties of the material forming the gasket 3006 (e.g., flexibility, softness, thickness, etc.) of the material. Additionally or alternatively, placing the tag 9200 on or within the gasket 3006, e.g., between the patient's skin and the gasket 3006, may cause patient discomfort. That is, the tag 9200 may be positioned within the gasket 3006.

[0597] Although Figure 7A and Figure 7B The lower tube patient interface 3000' is depicted and the position of the tag 9200 near the opening 3008 is discussed, but an upper tube patient interface may also be used according to the technique. In the upper tube patient interface 3000', the position of the tag 9200 may be, for example, closer to the upper region of the patient interface 3000'. In some aspects, the position of the tag 9200 on the patient interface 3000' may depend at least in part on whether the patient interface 3000' employs an upper tube or a lower tube configuration so as to position the tag 9200 to be closer to the proximal portion of the air circuit 4170 and the antenna 9100 when attached to the patient interface 3000'.

[0598] Figure 8A and Figure 8B An alternative exemplary patient interface 3000" is depicted. For example, the patient interface 3000" may be used in conjunction with the system 8000 or system 8000' described above with respect to Figure 5A and Figure 5B respectively. Figure 8A shows a rear view of the patient interface 3000", while Figure 8B shows a top view of the patient interface 3000". The patient interface 3000' may generally be referred to as a nasal pillow. For example, the patient interface 3000" may be configured to be partially inserted into the patient's nose.

[0599] Figure 8A and Figure 8BDotted lines are included to better illustrate and describe the various parts of the patient interface 3000" that will be described herein. However, the dotted lines are for purposes of description and do not necessarily indicate that different parts of the patient interface 3000" comprise different materials, properties, or colors, although in one instance, different parts may comprise different materials, properties, or colors.

[0600] The patient interface 3000" has a complex three-dimensional shape. For example, the patient interface 3000" includes various curves and contours. Multiple parts of the patient interface 3000" may be formed of a soft or flexible material, and other parts of the patient interface 3000" may be formed of a hard or rigid material. For example, the part of the patient interface 3000" that contacts the patient's face may be soft or flexible, and the part that facilitates connection between the air circuit 4170 and the patient interface 3000" may be hard or rigid. Additionally, the patient interface 3000" is smaller in size compared to the patient interface 3000' described above. Thus, placement of an RFID tag such as the tag 9200 on the patient interface 3000" presents unique considerations.

[0601] The patient interface 3000" includes a first nasal cushion 3012A and a second nasal cushion 3012B on either side of the intermediate plane M. For example, the first nasal cushion 3012A is on a first (e.g., left or right) or the intermediate plane M, while the second nasal cushion is on a second (e.g., right or left) of the intermediate plane M. The first nasal cushion 3012A and the second nasal cushion 3012B are configured to be at least partially inserted into the patient's nostrils and are thus skin-contacting. 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 respectively 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 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, e.g., 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.

[0602] 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 material or a different material than 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 between the patient's skin.

[0603] The second part 3018B is located on either side of the first part 3018A. For example, the second part 3018B is located on the left side and the right side of the first part 3018A. The second part 3018B may be made of the same material as the first part 3018A or a different material. The second part 3018B is not configured to form a seal with the patient's skin and may not be configured to contact the patient's skin.

[0604] The third part 3018C is located outside each second part 3018B. For example, the third part 3018C is located on the left side of the first part 3018A and the right side of the second part 3018B. The third part 3018C includes a first side 3020A and a second side 3020B. The third part 3018C may not be configured to contact the patient's skin. Thus, the third part 3018C may be made of a harder or more rigid material. In the lower tube patient interface 3000", the air circuit 4170 may be connected to the patient interface 3000" at the first part 3018A, which is generally opposite the first nasal cushion 3012A and the second nasal cushion 3012B. Alternatively, in the tubular patient interface 3000", the air circuit 4170 may be attached to a catheter headgear, which may be attached to the third part 3018C. In some aspects, the position of the label 9200 on the patient interface 3000" may depend at least in part on whether an upper tube or a lower tube configuration is used with the patient interface 3000" so as to position the label 9200 closer to the proximal portion of the air circuit 4170 and the antenna 9100 when attached to the patient interface 3000".

[0605] When using the patient interface 3000", the air circuit 4170 having the antenna 9100 may be connected to the patient interface 3000". The label 9200 may be located near the connection position of the air circuit 4170. For example, the label 9200 may be coupled to the first part 3018A, the second part 3018B, or the third part 3018C. In some aspects, to avoid contact with the patient's skin, the label 9200 is coupled to the second part 3018B or the third part 3018C. In some configurations, the label 9200 may be positioned to straddle multiple parts of the patient interface 3000'. For example, a first part of the label 9200 may be on the second part 3018B while a second part of the label 9200 may be on the third part 3018C. In this way, the position of the label 9200 may vary between the first part 3018A, the second part 3018B, and the third part 3018C.

[0606] Due to challenges associated with contact with the patient's skin, placing the tag 9200 on or within the first nasal cushion 3012A, the second nasal cushion 3012B, and / or in some aspects the first portion 3018A may be less desirable. Additional or alternative challenges may be associated with one or more properties of the materials including the first nasal cushion 3012A and the second nasal cushion 3012B (e.g., flexibility, softness, thickness, etc. of the materials). Additionally or alternatively, placing the tag 9200 on or within the first nasal cushion 3012A and the second nasal cushion 3012B, e.g., between the patient's skin and the first nasal cushion 3012A or the second nasal cushion 3012B, may cause patient discomfort.

[0607] The tag 9200 can be placed on or in the patient interface 3000' in a variety of ways, similar to the ways of securing the tag 9200 to the patient interface 3000' discussed above. For example, the tag 9200 can be an encapsulated chip molded within the tubular portion 3018. Alternatively, the tag 9200 can be printed directly onto the tubular portion 3018 with a printed conductive ink (e.g., silver ink). The tag 9200 can be an inlay tag encapsulated within the tubular portion 3018. In such an instance, the tag 9200 (e.g., the inlay tag) can be inserted, for example, via automation into a cavity of a mold for the tubular portion 3018, and an injection mold and plastic can be injected over the inlay tag, thereby securing the inlay tag within or on the tubular portion 3018. Alternatively, the tag 9200 can be formed from conductive silicone and / or conductive strands printed on the tubular portion 3018. In another alternative, the tag 9200 can be formed from a conductive fabric having stretchable conductive (e.g., copper) traces. Thus, the tag 9200 can be formed by any one of these methods or any combination of these methods, including those known in the art. Additionally, the tag 9200 can be a separate component secured to the tubular portion 3018 by various suitable means known in the art, including but not limited to adhesives and / or one or more mechanical fasteners.

[0608] During use of patient interfaces 3000, 3000', 3000" or another suitable patient interface (collectively referred to as patient interfaces, and aspects described in connection with patient interface 3000 may be similarly applied to patient interfaces 3000' and / or 3000"), air circuit 4170 may be fluidly coupled to RPT device 4000 and patient interface 3000. As described above, RPT device 4000 may be configured to supply a gas flow, such as air supplemented with oxygen, to patient interface 3000 via air circuit 4170. RPT device 4000 may also be configured to receive a signal from RFID system 9000 once air circuit 4170 is coupled to patient interface 3000 (e.g., via data communication interface 4280 and / or central controller 4230). The signal may include information about patient interface 3000 or an accessory. For example, antenna 9100 or adapter 9400 in air circuit 4170 may detect tag 9200 in patient interface 3000 and may read information about patient interface 3000 associated with tag 9200. For example, the information may be sent to RPT device 4000 (e.g., to data communication interface 4280) via transceiver 9300.

[0609] In some aspects, the received information may be one or more of the following: for example, the type of patient interface 3000 used, characteristics of patient interface 3000 (e.g., one or more of cushion material, cushion size, catheter size, patient interface size, length of use of the patient interface, manufacturing date of the patient interface, a set of respiratory therapy conditions for which the patient interface is suitable for use therewith, etc.), date or time stamp of use, batch identification number of patient interface 3000, or serial number of patient interface 3000. In some aspects, the received information may be one or more of patient information, such as the type of treatment or treatment settings that the patient desires to receive, or other information. In some aspects, the received information may be whether air circuit 4170 and / or an accessory device (not shown) is connected or disconnected from patient interface 3000.

[0610] The RPT device 4000 can be configured to perform an action when receiving information about the patient interface 3000 from the RFID system 9000. For ease of description herein, the RPT device 4000 can be described as performing an action based on the receipt of information; however, this can mean that a controller incorporated as part of the RPT device 4000 (e.g., the central controller 4230 and / or the therapy control module 4330) can cause the RPT device to perform the action, or a controller separate from the RPT device 4000 can cause the RPT device 4000 to perform the action. For example, the RPT device 4000 can automatically control the operation of the therapy provided to the patient based on the received information or signal (e.g., via the central controller 4230 and / or the therapy control module 4330, as described above). For example, the breathing experience can be improved by determining whether the settings of the RPT device (e.g., air flow, humidity level, etc.) are properly aligned with the patient interface worn by the patient. In some configurations, the RPT device 4000 can implement the design of patient interface-specific ventilation and flow curves to facilitate a more comfortable and / or effective therapy delivery. In some aspects of the technology, an indication for the patient can be generated based on the information received by the RPT device 4000. For example, an indication can be generated that the type or size of the patient interface being used is incorrect, the gasket or the entire patient interface should be replaced, the RPT device 4000 is configured with one or more incorrect settings that should be changed by the patient, or other suitable indications. The indication can be generated, for example, to an external device, such as the remote external device 4286 or the local external device 4288 (e.g., the patient's tablet, smart phone, or computer, or the device of a healthcare provider), on one or more displays of the RPT device 4000 or other components of the system 8000. In other aspects, the respiratory therapy system 8000 can receive input from the patient. For example, the patient can enter information about the patient interface 3000 during a therapy session, and the input received from the patient can be compared with the information received from the patient interface 3000 in the RFID system 9000 to confirm the accuracy of the patient input. In some aspects, the information received from the RFID system 9000 can be used to track the use or other characteristics of the patient interface in use.

[0611] In other aspects of the present technology, information received from the patient interface 3000 can be received by the RPT device 4000 in addition to information received from other sensors or systems associated with the system 8000 or system 8000' (collectively the system, where aspects described in connection with system 8000 can be similarly applied to system 8000'). For example, sensors or systems configured to detect air flow, pressure, air leakage, humidity, or other characteristics of the system 8000 can send information to the RPT device 4000. The RPT device 4000 can analyze or interpret information received about the patient interface 3000 from the RFID systems 9000, 9000' (collectively the RFID systems, where aspects described in connection with RFID system 9000 can be similarly applied to RFID system 9000') in combination with one or more other sensors. For example, information about the type or size of the patient interface being worn or how long the patient interface has been in use can be received from the RFID system 9000. The system 8000 can also receive information from other sensors or patient input about patient interface discomfort or the occurrence of a leak.

[0612] The system 8000 can analyze this information together and can take an action based on the collective information. For example, if patient interface discomfort is indicated by the patient or a leak is detected using the patient interface, based on information received from the RFID system 9000, the RPT device 4000 can generate an indication to the patient that a different size or type of patient interface should be used, that a different size or type of gasket should be used, or that a new patient interface or gasket should be used. The indication can include, for example, a recommendation about the type or size of patient interface or gasket to be used or guidance on how to select a better-fitting gasket or patient interface type or size. The indication can be generated to an external device (such as the remote external device 4286 or the local external device 4288 (such as the patient's tablet, smart phone, or computer, or the device of a healthcare provider)) on one or more displays of the RPT device 4000 (such as the display 4294) or other components of the system 8000 as described above. In other aspects, one or more settings of the RPT device 4000 can be changed based on the collective information received from the RFID system 9000 and other information from the system 8000. In some aspects, the indication can be that the air circuit 4170 is not coupled to the patient interface 3000 or is not correctly coupled to the patient interface 3000.

[0613] In some aspects, system 8000 can indicate to the patient when the patient interface or cushion has been worn for a sufficient length of time, or is an old enough production batch identification number or serial identification number that may affect performance, and a new patient interface or cushion should be used. In some aspects, the age of the patient interface or how many times the patient interface has been used can result in an indicator that a new patient interface or new cushion should be used. System 8000 can indicate to the patient to replace the patient interface or cushion. The indication can also depend at least in part on the recommended usage period of a particular patient interface or cushion type, the type of treatment administered to the patient, or one or more other factors. The indication can be generated as described above, for example, on one or more displays of the RPT device 4000 (such as display 4294) or one or more displays of system 8000, 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 the healthcare provider's device), or to a cloud server, such as a remote external communication network 4282 and / or a local external communication network 4284 and / or a remote external communication network 4282 (e.g., for remote monitoring to improve the patient experience, trigger commands (such as for a new patient interface or accessory, etc.)).

[0614] In some instances, system 8000 and / or system 8000' can include one or more external systems 9520 as shown in Figure 39 or be associated with one or more as shown in Figure 39communicates with an external system 9520 (e.g., via the Internet or other data communication networks). Illustrative examples of external systems include 4286 and 4288 discussed herein. Such an external computer system can be, for example, a dedicated service and / or hosted on a cloud computing platform (such as AWS, Azure, etc.). Any or all of the analysis, processing, operations, and / or actions performed by system 8000 and / or system 8000' (discussed herein) can alternatively be performed by or in conjunction with one or more computer systems. As an illustrative example, data can be received by an RPT device 4000, which includes: 1) data from tags included in the patient interface (e.g., identifying which type of patient interface is being used and / or other data as discussed herein) or other components of system 8000 or system 8000', and 2) data from sensors associated with the operation of system 8000 (or 8000') (e.g., airflow, pressure, air leak, humidity, VOC sensors, etc.). The RPT device 4000 can transmit such data to one or more computer systems for processing, analysis, etc. Then, one or more data messages can be transmitted back to the RPT device 4000 from the one or more computer systems to perform, for example, changing or modifying its operation. The content of the data message and / or the transmission back to the RPT device can be based on the processing and / or analysis performed by the one or more computer systems. In some instances, any or all of the analysis or processing performed by system 8000 and / or system 8000' can 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.

[0615] The antenna 9100 and transceiver 9300 can read the signal from the tag 9200 at least once during a treatment session. For example, when treatment begins, such as when a start button is pressed or when automatic start is initiated, the tag 9200 can be read. In some aspects, if no accessory or air circuit 4170 is detected attached to the patient interface 3000, the RFID system 9000 can continue to read, for example, continuously or at regular intervals. In some configurations of the technology, the signal from the tag 9200 can be read periodically, such as every few seconds, minutes, or hours. In some instances of the technology, the antenna 9100 and transceiver 9300 can read the signal from the tag 9200 according to a regular or irregular frequency. For example, the signal can be read more or less frequently at the start of a session or after a predetermined amount of time. In some aspects, the frequency can increase if an unexpected read occurs or in the case of a read failure. In some aspects, the type of treatment given or the type of patient interface used can at least partially determine the frequency of reading the tag 9200. In some instances, data can be obtained from the tag 9200 and / or sensors based on instructions generated or received from, for example, the RPT device 4000 and / or an external computing system hosted, for example, in a cloud computing platform. For example, the VOC sensors discussed herein can be used to obtain such data based on instructions received, for example, from a physician.

[0616] As described herein (e.g., see Figure 5B ), the RFID system can include an adapter 9400 that forms a distinct component configured to be fixedly or removably coupled between the air circuit 4170 and the patient interface 3000. The adapter 9400 can include or incorporate the antenna 9100, the transceiver 9300, and / or one or more sensors. Thus, the adapter 9400 can be used in conjunction with various air circuits 4170 or can be used to improve an air circuit 4170 that does not have an antenna, transceiver, and / or one or more sensors. In some aspects, the adapter 9400 can be reusable and the air circuit 4170 can be replaceable. In an instance, one or more sensors of the antenna 9100, transceiver 9300, and / or adapter 9400 can have any or all of the characteristics of the antenna 9100, transceiver 9300, and / or one or more sensors described in this application.

[0617] Figures 11 to 38 An air adapter tube 9400 (also referred to as an adapter) according to an example of the technology is shown. As shown, the air adapter tube 9400 includes a tubular body 9410 (or lumen) configured to convey pressurized treatment 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 (e.g., seeFigures 36 to 37 ), the distal end 9430 is configured to be connected to an air delivery tube 4170 (e.g., see Figures 15 to 19 , Figure 33 and Figure 35 ). Accordingly, 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.

[0618] The tubular body 9410 includes a tube wall 9412 that forms a path for conveying an air flow, one or more electrical conductors 9414 (e.g., copper wire or aluminum wire), and spiral or helical ribs 9416, e.g., see Figure 11 , 12 , 20, 21, and 31.

[0619] In one example, the tubular body 9410 may include a flexible material. For example, the tube wall 9410 may include 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 include or may be covered with a textile material. For example, the tube wall 9410 may include or be covered with a textile material, as Figures 11 to 19 shown. For example, the tube wall 9410 may include a membrane (e.g., including a polymeric material) covered with a textile material. However, the tube wall may include other materials, such as polymers. In one example, the tube wall 9410 may include a textile material and may include a different color (e.g., blue), e.g., in order 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 are possible, such as oval. In one example, the tubular body may include an inner diameter between approximately 10 - 15 mm, e.g., 12 mm, such that the air adapter tube is flexible, soft, and light to enhance the user experience. In one example, the inner diameter is at least 12 mm, e.g., 12 - 15 mm, to reduce impedance. In one example, the tubular body may include a length between about 5 - 15 cm, e.g., 8 - 10 cm, 8.5 - 10 cm, 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), e.g., such that the air adapter tube will hang vertically downward from the patient interface during use and the air adapter tube will not act like a lever arm and / or the weight of the air adapter tube will not create a tube resistance that adversely affects the seal of the patient interface.

[0620] One or more electrical conductors 9414 are configured to carry or transmit electrical signals and / or power. One or more electrical conductors 9414 may extend through the length of the tubular body 9410, e.g., to provide heat to a length (partial or full) of the air adapter tube 9400 and / or to transmit electrical signals and / or power from a proximal end 9420 to a distal end 9430 (e.g., from a sensor located at the proximal end 9420).

[0621] In one instance, the tubular body 9410 may include four electrical conductors 9414, although more or fewer conductors are possible, such as two, three, or more electrical conductors. For example, the tubular body may include two electrical conductors 9414, i.e., one conductor for power and one conductor for data / signals. In one instance, if needed, two additional wires may be provided for heating. That is, if the tubular body is not provided with or does not require heating, the tubular body may include only two wires for power and data / signals. In one instance, each electrical conductor may include a 30 AWG (American Wire Gauge) wire, although alternative wire gauges are possible.

[0622] In one instance, helical ribs 9416 are wound helically along the length of the tube wall 9412, e.g., along the outer surface of the tube wall. The helical ribs 9416 may be integrally formed with the tube wall 9412 (e.g., made of a fabric or polymer material) or may be formed separately and attached to the tube wall 9412. The helical ribs 9416 are configured to increase the rigidity of the tube wall and / or provide additional insulation. Additionally, the helical ribs 9416 are configured to provide a sheath for one or more electrical conductors 9414, i.e., to surround one or more electrical conductors to insulate and / or protect the electrical conductors.

[0623] The proximal end 9420 of the air adapter tube 9400 is configured to be repeatedly connected to and disconnected 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 each other, the proximal end 9420 is configured to form a substantially fluid-tight seal with the patient interface 3000.

[0624] In the illustrated instance, the proximal end 9420 includes a ferrule portion 9440 (also referred to as a ferrule front) and a mechanical connector (e.g., a clip member 9450) configured to connect to the patient interface. In the illustrated instance, as Figure 20 and Figure 21As shown, the clip member 9450 includes a structure separate and distinct from the mouthpiece portion 9440, i.e., the mouthpiece portion 9440 and the clip member 9450 include separately molded components that are subsequently connected to each other. In the illustrated example, the clip member 9450 is configured to provide a releasable connection to the mouthpiece portion 9440, such as a releasable snap-fit connection or a separable snap engagement assembly.

[0625] As shown, the mouthpiece portion 9440 includes one or more recesses 9442 that are configured to receive the clip member 9450, i.e., an upper recess 9442U that extends along the upper portion of the mouthpiece portion 9440 and that leads to side recesses 9442S on the respective sides of the mouthpiece portion 9440 (e.g., see Figures 20 to 21 ). Each side recess 9442S forms a unique indentation that is configured and arranged to interact with a corresponding lug 9452 of the clip member 9450 to facilitate holding the clip member 9450 on the mouthpiece portion 9440 (e.g., see Figure 11 ). When connected, the clip member 9450 is disposed along the outer surface of the mouthpiece portion 9440 outside of the airflow path formed by the mouthpiece portion 9440.

[0626] The mouthpiece portion 9440 also includes a tubular end 9445 that is configured to extend at least partially into the connection port 3600 of the patient interface 3000 to form a substantially fluid-tight seal with the patient interface 3000 for delivering pressurized gas (e.g., see Figures 36 to 37 ). In an alternative example, the connection port 3600 may extend at least partially into the mouthpiece portion 9440 to form a substantially fluid-tight seal.

[0627] The clip member 9450 includes a pair of resilient quick-release clip arms or clips 9454 and a connection portion 9456 that interconnects the clip arms 9454. Each clip arm 9454 includes a snap portion 9454C and a button or finger portion 9454B. The clip arms 9454 are configured and arranged to provide a releasable snap-fit connection or a separable snap engagement assembly with the patient interface, e.g., a snap portion 9454C configured to deflect along the connection port 3600 of the patient interface 3000 and snap into a clip channel 3605 (e.g., see Figure 36 ). The button portion 9454B is configured and arranged to be manually clamped or squeezed to deflect the snap portion 9454C to separate or release the snap portion from the patient interface 3000 and thus allow the air adapter tube 9400 to be separated from the patient interface 3000 (e.g., see Figure 37)。In the illustrated example, each snap portion 9454C includes an entry corner to facilitate push - in assembly and a 90° return corner to prevent or inhibit pull - out disassembly. For example, the user must deflect the snap portion through the button portion to allow disconnection. Additionally, each clip arm 9454 includes a lug 9452 to facilitate holding the clip member 9450 on the socket portion 9440 (e.g., see Figure 11 ).

[0628] In the illustrated example, the clip member 9450 includes an open - end configuration having a semi - flexible and generally semi - circular connecting portion 9456 that allows the clip member 9450 to be connected to the socket portion 9440, for example, in a manner similar to a retaining ring. When connected, the connecting portion 9456 of the clip member 9450 is arranged within the upper recess 9442U of the socket portion 9440 (e.g., see Figure and ​ ) and the clip arms 9454 are arranged along the respective sides of the socket portion 9440, where the lugs 9452 fit into the respective side recesses 9442S of the socket portion 9440 to securely and releasably interconnect the clip member 9450 and the socket portion 9440 in the assembled position (e.g., see ​ ). In an alternative example, the clip member 9450 may be non - removably or permanently connected to the socket portion 9440. In another example, the clip member and the socket portion may be integrally formed as a single - piece structure.

[0629] 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) configured to matingly receive the snap portion 9454C of the clip member 9450. For example, the clip channel 3605 may be configured to receive ribs or catches of each of these snap portions 9454C to releasably attach the air adapter tube 9400 to the patient interface 3000 and form a rotational connection, for example, allowing the air adapter tube 9400 to freely rotate 360° about the axis of the connection port 3600 relative to the patient interface 3000. The button portion 9454B can be manually clamped or squeezed to disengage the snap portion 9454C from the clip channel 3605 (e.g., see ​ ).

[0630] In the illustrated example, as ​As shown, when the air adapter tube 9400 is connected to the patient interface 3000, the tubular end 9445 of the socket portion 9440 extends at least partially into the connection port 3600 such that at least the 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 the delivery of pressurized gas. In one example, the front end of the tubular end 9445 may engage a portion of the connection port 3600 to form a seal with the connection port 3600.

[0631] In addition, the socket portion 9440 includes one or more radially outwardly extending flanges 9446 (forming at least a portion of the recess 9442), which act as a stop to prevent the air adapter tube 9400 from being over-inserted into the patient interface, see for example ​ and ​ .

[0632] In one example, the air adapter tube 9400 may provide decoupling of the air delivery tube 4170 from the patient interface 3000, e.g., decoupling the tube resistance on the patient interface to prevent seal instability. For example, the decoupling may be provided by the clamp arm 9454, which forms a rotational connection that allows 360° free rotation of the air adapter tube 9400 (and thus the air delivery tube 4170) relative to the patient interface 3000.

[0633] In an alternative example, instead of the clip member 9450, the mechanical connector of the air adapter tube 9400 may include a conical body configured to connect to the patient interface by an interference fit or a friction fit. For example, the socket portion 9440 of the air adapter tube may include a conical body configured to connect to the connection port 3600 of the patient interface 3000.

[0634] In the example shown, the proximal end 9420 includes one or more adapters to connect the socket portion 9440 and support or house the antenna 9100, transceiver 9300, and / or one or more sensors.

[0635] As Figure 20 and Figure 21 shown, the proximal end 9420 includes a first adapter element 9460 (also referred to as a pre-block or pre-block 1) and a second adapter element 9470 (also referred to as an adapter element or pre-block 2).

[0636] The first adapter element 9460 includes a body portion 9462 and a tubular protrusion 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 protrusion 9464 is configured to support and / or hold the antenna 9100, transceiver 9300, and / or one or more sensors.

[0637] The second adapter element 9470 is constructed and arranged to interconnect the first adapter element 9460 with the wall 9410 of the tubular body. For example, the second adapter element 9470 includes a first end 9471 connected to the wall 9410 and the helical rib 9416. For example, the second adapter element 9470 is overmolded onto the wall 9410 (e.g., a membrane) and / or the helical rib 9416 such that the second adapter element 9470 is connected to and sealed with the wall 9410 and / or the helical rib 9416. The second adapter element 9470 includes a second end 9472 (opposite the first end 9471) connected to the body portion 9462 of the first adapter element 9460. For example, the second adapter element 9470 is overmolded onto the first adapter element 9460. However, it should be understood that the first adapter element 9460, the second adapter element 9470, the wall 9410, and the helical rib 9416 can be formed and connected to each other in other suitable ways, such as overmolded connections, mechanical connections, and integrally formed as a single piece.

[0638] In the illustrated example, the transceiver 9300 is disposed on a printed circuit board (PCB) 9500. An example of the PCB 9500 is a flexible printed circuit (FPC) or flexible circuit board 9480. Similar to the examples described herein (e.g., see Figure 6A and Figure 6B ), the FPC 9480 includes one or more bendable or flexible materials that are constructed and arranged to allow the FPC 9480 to bend or flex around the tubular projection 9464 of the first adapter element 9460. For example, see Figures 20 to 24 and Figures 27 to 32 .

[0639] As shown, the FPC 9480 includes a first end 9481 and a second end 9482 opposite the first end 9481. Each of the first end 9481 and the second end 9482 includes a respective opening 9481o, 9482o (e.g., see Figure 32 and Figure 38 ). The FPC 9480 is configured to bend or flex around the outer cylindrical surface of the tubular projection 9464, and the first and second ends 9481, 9482 at least partially overlap to allow the retaining member 9465 (extending radially outward from the tubular projection 9464) to project through one or both of the respective openings 9481o, 9482o, thereby supporting, holding, aligning, and orienting the FPC 9480 in place on the first adapter element 9460. For example, see Figure 20 , Figure 21 and Figure 32That is, the first adapter element 9460 includes at least one feature (e.g., a fastener (e.g., retention member 9465) and / or an adhesive (e.g., silicone)) configured to support and hold the FPC 980.

[0640] The tubular protrusion 9464 of the first adapter element 9460 further includes at least one port 9467 that allows at least one sensor (e.g., pressure sensor 9490) provided to the FPC 9480 to project radially inwardly into and / or through the port 9467. That is, the port 9467 allows the pressure sensor 9490 provided to the FPC 9480 to communicate with the air flow through the air adapter tube 9400. In one example, silicone may be provided to seal the sensor 9490 within the port 9467.

[0641] A sensor support 9466 is also provided to the first adapter element 9460. The sensor support 9466 extends radially inwardly from the tubular protrusion 9464 and includes an internal recess configured to receive a sensor (e.g., a thermistor or a gas temperature sensor 9492) provided to the FPC 9480. In the illustrated example, the sensor support 9466 and the corresponding temperature sensor 9492 (e.g., a thermistor) communicate with the air flow through the air adapter tube 9400, e.g., to 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.

[0642] In one example, the pressure and temperature sensed by the sensors 9490, 9492 may be provided to the FPC 9480. For example, an electronic circuit included in the air adapter tube 9400 may be used to read data from the sensors. The data is then converted into a format by the electronic circuit and transmitted to a controller (e.g., via electrical conductors 9414 (wires) and / or an antenna 9100). In one example, sensors (e.g., including 9490, 9492) included in the air adapter tube 9400 may be polled or otherwise transmit data at the same or different rates. In one example, any or all sensors of the air adapter tube 9400 may be polled continuously or at a reduced (or on-demand) frequency. As an illustrative example, the pressure sensor 9490 may be polled at a rate of no less than 500 Hz. The polling rate of a given sensor may be based on how the data is used. In one example, polling of some sensors included in the air adapter tube 9400 may be performed at a lower frequency. For example, as an illustrative example, data from an inertial sensor may be polled once every 1 minute, etc.

[0643] Data from pressure and / or temperature sensed by sensors 9490, 9492 (or other sensors discussed herein) can be transmitted to another system, such as an external computer system (e.g., a cloud computing platform, a mobile device, etc.) and then processed or analyzed thereon. The results of such processing or analysis can then be transmitted back to the RPT device 4000 and / or the adapter for use (e.g., to control parameters related to the treatment delivered to the patient).

[0644] In one instance, pressure data (or data based thereon) from pressure sensor 9490 can be transmitted back to the RPT device or the flow generator and used to control the pressure supplied to the patient. In one instance, the data acquired by pressure sensor 9490 can be used for real-time control of the generated pressure. In one instance, the pressure value provided by pressure sensor 9490 can be used in the same or a similar manner as pressure sensor 4272 discussed herein. In any instance, the pressure value provided by pressure sensor 9490 can be used to calculate Pm, or used in conjunction with the interface pressure estimation algorithm 4312 discussed herein. In one instance, data from pressure sensor 9490 can be used to compensate for pneumatic errors within the air circuit (e.g., air circuit 4170).

[0645] The socket portion 9440 is configured to connect to the first adapter element 9460. When connected, the socket portion 9440 and the first adapter element 9460 form an annular space 9447 therebetween, which annular space 9447 is configured to receive the FPC 9480 that supports the pressure sensor 9490 and the temperature sensor 9492, see for example Figure 31 and Figure 34 .

[0646] In one instance, the socket portion 9440 can be fixed to the first adapter element 9460 by ultrasonic welding. In one instance, the first adapter element 9460 can include one or more energy directors (e.g., along the free end of the tubular protrusion 9464 and / or along the outer perimeter of the first adapter element 9460) to facilitate the ultrasonic welding process. For example, the energy directors can include raised flanges (e.g., raised flange 9469b1 along the free end of the tubular protrusion 9464 and raised flange 9469b2 along the outer perimeter of the first adapter element 9460, as shown in Figure 20 、 Figure 27 and Figure 34 ) to accelerate the formation of the joint between the socket portion 9440 and the first adapter element 9460 during the ultrasonic welding process.

[0647] In one instance, at least one vent hole 9468 can be provided along the perimeter of the first adapter element 9460, see for example Figure 20 、Figure 22 , Figure 28 and Figure 34 . As shown, the vent hole 9468 includes a first end 9468.1 that communicates with the annular space 9447 that houses the FPC 9480 and a second end 9468.2 that communicates with the exterior of the air adapter tube, such as the surrounding environment. In one example, the first end 9468.1 may include a larger diameter than the second end 9468.2, and the vent hole 9468 may include a non-linear path from the first end 9468.1 to the second end 9468.2. In one example, a waterproof pressure balance membrane may be provided to the vent hole 9468, for example, on the first end 9468.1. The waterproof pressure balance membrane may be configured to regulate the pressure difference at the proximal end 9420 (between the annular space 9447 and the surrounding environment) and prevent damage while preventing water / dust from entering the annular space of the FPC 9480. That is, the waterproof pressure balance membrane ensures pressure balance between the annular space 9447 and the surrounding environment such that the FPC 9480 and its sensors (e.g., pressure sensor 9490) can function reliably.

[0648] The distal end 9430 of the air adapter tube 9400 is configured to be repeatedly connected to and disconnected from the air delivery tube 4170 to facilitate a releasable or separable connection between the air adapter tube 9400 and the air delivery tube 4170, see for example Figures 15 to 19 . When the air adapter tube 9400 and the air delivery tube 4170 are connected to each other, the distal end 9430 is configured to form a substantially fluid-tight seal with the air delivery tube 4170.

[0649] In the example shown, the distal end 9430 includes a socket portion 9432 and an electrical connector 9434 disposed, for example, on the upper side of the socket portion 9432. The electrical connector 9434 includes a lead frame having one or more electrical contacts 9435 (e.g., four contacts), the electrical contacts 9435 being configured to transmit power and / or signals. The electrical contacts 9435 are electrically connected to corresponding electrical conductors 9414 (wires) that extend along the tubular body 9410. The electrical connector 9434 is configured to be electrically connected to a corresponding electrical connector 4175 of the air delivery tube 4170 (e.g., a heated air delivery tube).

[0650] The distal end 9430 of the air adapter tube 9400 includes a mechanical connector (e.g., recessed side 9436) configured to mechanically connect to a corresponding mechanical connector (e.g., a pair of resilient quick-release clip arms or clips 4177) of the air delivery tube 4170. Each clip arm 4177 includes a snap portion 4177C and a button or finger portion 4177B. The clip arms 4177 are constructed and arranged to provide a releasable snap-fit connection or detachable snap engagement assembly with the distal end 9430. For example, the snap portion 4177C is configured to deflect and snap into a corresponding one of the recessed sides 9436, as Figures 15 to 19 shown. The button portion 4177B is constructed and arranged to be manually clamped or squeezed to deflect the snap portion 4177C for separating or releasing the snap portion from the distal end 9430 and thus allowing the air delivery tube 4170 to be separated from the air adapter tube 9400.

[0651] As Figure 25 and Figure 26 shown, the mechanical connector (e.g., clip arms 4177) of the air delivery tube 4170 can be constructed as a separate and distinct clip member 4185 configured to provide a releasable connection with the socket portion 4171 of the air delivery tube 4170, e.g., similar to the clip member 9450 described herein. For example, the clip member 4185 can be arranged within a recess of the socket portion 4171 where multiple lugs of the clip member 4185 mate into corresponding side recesses to forcefully and releasably interconnect the clip member 4185 with the socket portion 4171 in an assembled position. In another example, the clip member and the socket portion can be integrally formed as a single-piece structure.

[0652] However, it should be understood that the distal end 9430 and the air delivery tube 4170 can be connected to the air delivery tube 4170 in other suitable ways. In an alternative example, the distal end 9430 and the socket portion 4171 can include tapered bodies configured to connect to each other with an interference fit or a friction fit.

[0653] In the illustrated example, the air delivery tube 4170 does not include any sensors (e.g., temperature sensors, pressure sensors, etc.). In an alternative example, the air delivery tube 4170 can include at least one sensor (e.g., a temperature sensor), e.g., at least one sensor not provided to the air adapter tube 9400.

[0654] When the air delivery tube 4170 is connected to the air adapter tube 9400, the socket portion 4171 includes a tubular end 4181 that is configured to at least partially extend into the opening 9437 of the socket portion 9432 such that at least the radially outward surface of the tubular end 4181 engages the socket portion 9432 to form a substantially fluid-tight seal with the air adapter tube 9400 for delivering pressurized gas, see, for example Figure 15 , Figure 16 and Figure 35 . In one example, the front end of the tubular end 4181 can engage a portion of the socket portion 9432 to form a seal with the socket portion 9432.

[0655] In the illustrated example, as Figure 12 , Figure 15 , Figure 16 , Figure 25 and Figure 26 shown, the socket portion 9432 includes a radially inwardly extending protrusion 9439 that is configured to engage a corresponding recess 4189 in the tubular end 4181 when the air delivery tube 4170 is connected to the air adapter tube 9400, for example to facilitate alignment and prevent relative rotation.

[0656] In the illustrated example, the proximal ends 9420 of the air adapter tube 9400 and the air delivery tube 4170 include similar mechanical and pneumatic connectors (e.g., a pair of resilient quick-release clip arms 9454, 4177 and tubular ends 9445, 4181) that are configured to allow both the air adapter tube 9400 and the air delivery tube 4170 to form mechanical and pneumatic connections with the patient interface 3000. For example, the air adapter tube 9400 and the air delivery tube 4170 can be independently connected to the patient interface 3000.

[0657] In one example, as Figure 12 , Figure 15 , Figure 17 , Figure 20 and Figure 25 shown, the socket portion 9432 of the distal end 9430 can include an indicator or guide (e.g., an alignment arrow 9433) that is configured to align with a corresponding indicator or guide (e.g., an alignment arrow 4173) provided to the socket portion 4171 of the air delivery tube 4170, for example to facilitate and confirm the correct orientation, alignment, and connection of the air adapter tube 9400 with the air delivery tube 4170.

[0658] 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 corresponding contacts of the electrical connector 4175 provided to the air delivery tube 4170 to form an electrical and control signal connection to the air delivery tube 4170. See, for example, Figure 35 . In the illustrated example, a lead frame having electrical contacts 9435 on the air adapter tube 9400 is arranged as a male connector that is configured to form an electrical connection and a signal connection when inserted into engagement with the electrical connector 4175 arranged as a female connector on the air delivery tube 4170, i.e., a plug-in connection or a direct insertion connection. The electrical connector 4175 electrically connects its contacts to corresponding wires extending along the air delivery tube 4170. In one example, the electrical connection can be facilitated by using, for example, serial communication such as RS485. However, it should be understood that the electrical contacts can have alternative configurations and arrangements, e.g., depending on the interface arrangement or connection mechanism provided between the air adapter tube and the air delivery tube.

[0659] An electrical conductor 9414 (wire) extending along the tubular body electrically connects the electrical connector 9434 to a transceiver (such as FPC 9480) and / or one or more sensors at the proximal end 9420. Thus, electrical signals (e.g., from one or more sensors) can be transmitted from the proximal end 9420 to the distal end 9430, from the distal end 9430 to the air delivery tube 4170, and from the air delivery tube 4170 to the RPT device or the flow generator (e.g., the RPT device or the flow generator can be configured to be controlled based on the output from one or more sensors).

[0660] As described herein, the air adapter tube 9400 includes at least one sensor supported at the proximal end 9420 by the FPC 9480, such as a pressure sensor 9490, a temperature sensor 9492. In an example, the at least one sensor can include the pressure sensor 9490 and / or the temperature sensor 9492 as described herein, and can also include one or more additional sensors, such as a flow rate sensor, a humidity sensor, and / or an inertial sensor. The inertial sensor can include, for example, an accelerometer, a gyroscope sensor, a magnetometer, etc.

[0661] The at least one sensor can generate one or more output signals that can be transmitted to a controller for diagnosing and / or treating a respiratory disorder. For example, a pressure sensor 9490 can be configured to generate a pressure signal of air passing at the proximal end 9420 for diagnosing and / or treating a respiratory disorder. A temperature sensor 9492 can be configured to generate a signal indicating the air temperature at the proximal end 9420. An accelerometer sensor can be configured to generate a signal indicating patient movement and / or patient sleep position, and this data can be used to allow for personalization of the patient interface based on the detected sleep pattern.

[0662] In one instance, sensors can be provided to the FPC 9480 that are configured to generate signals indicating the respiration of the patient's exhaled gas and / or biomarkers of the patient's exhaled gas, such as a CO2 sensor, a biomarker sensor.

[0663] For example, the proximal end 9420 can include a CO2 sensor configured to detect CO2 accumulation, rebreathing CO2 levels, and / or respiratory comfort. In one instance, the CO2 sensor is arranged in the patient interface, between the patient and the ventilation on the patient interface, i.e., in a position facilitating detection of the patient's exhaled gas. In one instance, the sensor or the ventilation can be moved or repositioned such that the CO2 sensor is arranged upstream of the ventilation, i.e., allowing the sensor to detect the exhaled gas before it exits the patient interface via the ventilation. In one instance, data from the CO2 sensor can be transmitted to the RPT device and used to control (e.g., dynamically) the pressure supplied to the patient, for example. If the CO2 reading is high (e.g., above a threshold amount), the pressure supplied from the RPT device can be increased. The resulting increased pressure (e.g., and corresponding flow) can be used to lower the patient's CO2 level.

[0664] In one instance, the CO2 sensor can be configured to detect end-tidal CO2, which can be an indication of a patient's health. For example, a low end-tidal CO2 reading can indicate poor perfusion, low blood volume, or sepsis, while a high end-tidal CO2 reading can indicate airway narrowing, airway obstruction, or respiratory distress. The end-tidal CO2 reading can help healthcare providers determine whether the patient is being adequately ventilated. In one instance, the end-tidal CO2 reading can be collected within the air adapter tube, i.e., there is no need to provide a CO2 sensor within the patient interface.

[0665] In one instance, the proximal end 9420 can include a VOC (volatile organic compound) sensor configured to detect biomarkers within the patient's breath. For example, the VOC sensor can be configured to detect asthma, diabetes, lung cancer, alcohol, and other health conditions.

[0666] In one example, a CO2 sensor and / or a VOC sensor can be configured to take a reading prior to treatment, i.e., the CO2 sensor and / or the VOC sensor can perform a pre-treatment analysis prior to the delivery of pressurized therapeutic air by the RPT device or the flow generator. For example, prior to the start of treatment, a patient can wear a patient interface (operatively connected to the RPT device via an air adapter tube 9400) for one or more respiratory cycles (e.g., 1 - 10 breaths), which allows the CO2 sensor and / or the VOC sensor provided to the air adapter tube 9400 to take a reading for analysis prior to the patient starting treatment. After one or more respiratory cycles, the RPT device can be activated to deliver pressurized breathable air for treatment. In one example, the readings from the CO2 sensor and / or the VOC sensor can be provided to the patient in real-time or can be provided to a healthcare professional for analysis prior to communicating with the patient. In this example, the patient interface is worn and treatment is delayed for one or more respiratory cycles to allow sensing by one or more sensors (e.g., the CO2 sensor and / or the VOC sensor) to be completed.

[0667] In one example, the readings from the CO2 sensor and / or the VOC sensor can be automatically performed at the start of treatment, prior to the start of treatment, and / or prior to the provision of airflow to the patient. In some examples, a patient wearing the patient interface can be automatically detected (e.g., based on readings from an accelerometer, etc.) and then used to trigger (in whole or in part) the CO2 sensor and / or the VOC sensor to obtain data related to the patient's respiration. In one example, the readings from the CO2 sensor and / or the VOC sensor can be obtained as part of the startup process of the RPT device. The startup process can include additional aspects such as checking the type of patient interface (via a label as discussed herein), verifying the firmware of the RPT device, and / or the parameters to be used in the treatment to be provided. Thus, in some examples, data acquisition from the CO2 sensor and / or the VOC sensor can be performed without explicitly prompting, for example, the patient to perform such a reading.

[0668] In one example, the air adapter tube 9400 may include one or more additional features to enhance control and / or sensing capabilities. For example, the air adapter tube 9400 may include an on / off button for controlling power and / or may control power haptically based on an accelerometer sensor. The air adapter tube 9400 may include tube temperature up / down buttons to control the air temperature of the delivered air. The air adapter tube 9400 may include tube humidity up / down buttons to control the air humidity of the delivered air. The air adapter tube 9400 may include an optical or color sensor to detect one or more colors (e.g., color rings or gray scale gradients) on a portion of the patient interface or elbow, e.g., to detect patient movement or sleep position. The air adapter tube 9400 may include a light sensor to project light and facilitate paced breathing. The air adapter tube 9400 may include a microphone for detecting, e.g., snoring, mouth leaks, voice commands.

[0669] In one example, ventilation may move from the patient interface and into the air adapter tube (e.g., within the proximal end 9420 adjacent the patient interface), and the ventilation on the air adapter tube may be active and controlled (e.g., electric and / or pneumatic).

[0670] 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 the collected sensor data to an external device, including a smart phone or a flow generator. Similar to the examples described herein, the antenna 9100 is configured to face the proximal end and is located in a plane generally perpendicular to the axis of the proximal end 9420. The antenna 9100 forms an opening around or surrounding the lumen of the air adapter tube. The antenna 9100 is fixed and electrically coupled to the FPC 9480 by a bridge 9494, and the bridge 9494 includes one or more flexible portions to allow the antenna to bend relative to the FPC 9480 (e.g., approximately 90 degrees), e.g., see Figures 27 to 29 and Figure 38 . The antenna 9100 may have any or all of the characteristics of the antennas described herein.

[0671] Because the antenna 9100 is disposed in the proximal end 9420 of the air adapter tube 9400, the antenna 9100 is configured to be positioned near the connection port 3600 of the patient interface 3000 when the air adapter tube 9400 is coupled to the patient interface 3000, e.g., see Figures 36 to 37 . This arrangement allows the antenna 9100 to receive data transmitted from a tag (which may be the same or similar to the tag 9200, e.g., an RFID tag, an NFC tag, etc.) disposed on the patient interface 3000. Figure 36 and Figure 37An example of where the tag 3607 can be located is shown. The tag 3607 can be the same as or similar to the tag 9200 and be used in the manner described herein, such as to identify patient interfaces and / or patient data.

[0672] In the example shown, the FPC 9480 includes at least one wire connection point that connects the FPC 9480 and the antenna 9100 to at least one wire (e.g., electrical conductor 9414) that runs along and extends from the tubular body 9410. For example, as Figure 29 and Figure 38 shown, the FPC 9480 can include a bonding area 9484 that is configured to allow the FPC 9480 to form a bond (e.g., a soldered seam, a soldered joint) with each electrical conductor 9414 (e.g., 4 wires).

[0673] In the example shown, the FPC 9480 includes a linear portion that supports electronic components and at least one flexible bending portion between the linear portions to allow the FPC 9480 to bend or flex around the first adapter element 9460. In one example, the electronic components can be disposed on one or both sides of the FPC. In one example, the electronic components can include a pressure sensor 9490, a temperature sensor 9492, and / or an accelerometer sensor that is configured to signal a sleep position. In one example, the electronic components can include one or more sensors that are configured to generate signals representative of respiration and / or biomarkers indicative of a patient's health.

[0674] In the example shown, for example, see Figure 36 and Figure 37 , the air adapter tube 9400 is directly connected to the patient interface 3000 (i.e., there is no elbow or additional connector between the air adapter tube and the patient interface), which allows one or more sensors (and the antenna) provided to the FPC 9480 to be very close to the patient interface and its breathing chamber for collecting data. However, it should be understood that the air adapter tube 9400 can be arranged along the air delivery path between the patient interface and the RPT device in other suitable ways. For example, the air adapter tube 9400 can be configured to connect to an upper tube patient interface and a lower tube patient interface according to any of the examples described herein. For example, in Figures 10B to 10D the lower tube example shown, the air adapter tube 9400 can be configured to connect between the patient interface 3000 and the air delivery tube 4170 (e.g., via an elbow), while in Figure 10A the upper tube example shown, the gas adapter tube 940O can be configured to connect the headgear and the air delivery tube 4170 (e.g., via an elbow).

[0675] Figure 39is a block diagram showing adapter 9400', RPT device 4000, patient interface 3000, and one or more external systems 9520, all of which can communicate with each other using wired and / or wireless communication. Adapter 9400' can be the same as or similar to adapter 9400 discussed herein. Aspects of adapter 9400 can be similarly applied to adapter 9400', and aspects of adapter 9400' can be similarly applied to adapter 9400.

[0676] Adapter 9400' includes PCB 9500, which can be flexible in some instances. Adapter 9400' includes antenna 9100 coupled to transceiver 9300, and transceiver 9300 is configured to read data from tag 9200 of patient interface 3000. Antenna 9100 can be electrically connected to transceiver 9300 to transmit radio waves and receive signals from, for example, tag 9200.

[0677] Adapter 9400' further includes one or more sensors 9504, memory 9506, transceiver 9508, and controller 9502. Sensors 9504 can include any or all of the sensors discussed herein. Examples of sensors 9504 include pressure sensor 9490 and temperature sensor 9492. Memory 9506 is provided for local storage (e.g., on adapter 9400') of data received from sensors 9504, transceiver 9300, etc. Memory 9506 can also store program instructions that enable controller 9502 to perform operations. In some instances, memory 9506 can be part of the controller (e.g., as a system-on-chip (SoC)). In any instance, adapter 9400' further includes a power management system configured to provide an appropriate level of power to one or more of sensors 9504, memory 9506, transceiver 9508, controller 9502, and transceiver 9300.

[0678] Transceiver 9508 is included in adapter 9400' to provide data communication functionality for transferring data between adapter 9400' and RPT device 4000 (or other destinations as needed). Transceiver 9508 can provide wired, wireless, or both wired and wireless communication. In some instances, transceiver 9508 can be provided as part of the same circuit as transceiver 9300. Thus, for example, adapter 9400' can include a first transceiver that is wireless for transferring tag 9200 and a second transceiver that is wired for communicating with, for example, RPT device 4000 using a physical link (e.g., a wire).

[0679] In one example, transceiver 9508 provides the data link as described above and also provides power to the power management system of adapter 9400'. The power can be provided from an RPT device (e.g., as discussed herein) or can be provided via a battery or other power source.

[0680] Adapter 9400' also includes a controller 9502. Controller 9502 can include or be a hardware processor configured to execute computer-executable instructions to perform one or more operations. For example, controller 9502 can control sensor 9504 and / or transceiver 9300 to obtain data (e.g., data for physical phenomena or from tag 9200). In some cases, controller 9502 controls when to transfer data to RPT device 4000 (e.g., via the corresponding data link) and / or when to obtain data via sensor 9504 and / or transceiver 9300. Controller 9502 can include a hardware processor (e.g., an ARM microprocessor), memory (e.g., for programs and data), and I / O on a single integrated circuit. An illustrative example of a controller that can be used in the illustrative example of adapter 9400' is the STM32G071EBY6TR microcontroller.

[0681] In some examples, controller 9502 can be used to determine when the patient interface is being worn or used. This can be determined, for example, by interpreting data from an acceleration sensor to determine when the patient is wearing patient interface 3000. Based on this determination, the controller can activate one or more sensors to obtain data. For example, the CO2 sensor and / or (VOC) sensor discussed herein can be activated to obtain data from these sensors. This activation can occur before airflow is delivered to the patient. In some examples, when a reading from an airflow sensor (e.g., also provided in the adapter) indicates that no airflow is being delivered to the patient, the controller can activate the CO2 sensor and / or (VOC) sensor.

[0682] The components of adapter 9400' can all be provided on the same PCB 9500 or separately. For example, some or all of the sensors can be provided separately from PCB 9500 and electrically coupled to the PCB via leads, etc. In other examples such as Figure 38 shown, a sensor (e.g., pressure sensor 9490) can be provided on the PCB. Note that the antenna can be partially (or fully) integrated into PCB 9500 since it can be electrically connected to transceiver 9300 provided on PCB 9500.

[0683] According to various example embodiments, the controller 9502 may provide different types of functions. In some instances, the functions of the controller 9502 may include pre - processing or post - processing of data obtained from sensors and / or tags 9200. For example, various filtering, averaging, and / or other processing may be performed by the controller 9502. In other instances, the functions of the controller 9502 may be more restricted, as data from the sensors is transmitted back to the RPT device 4000 for processing by the controller 4230 thereon. Thus, in some instances, the controller 9502 may be responsible for processing or analyzing the acquired data, and in other instances may be responsible for operating different components of the adapter 9400' without performing such processing or analysis. Instead, such processing may be performed by the RPT device 4000 and / or the external system 9520.

[0684] As noted herein, each of the proximal end 9420 and the distal end 9430 of the air adapter tube 9400 may include an isoconical body configured to allow the air adapter tube 9400 to connect between any patient interface and the air delivery tube, rather than a customized mechanical connection (e.g., snap - fit clip arms), i.e., the air adapter tube 9400 is not limited to connecting to a patient interface or an air delivery tube having a compatible mechanical connector. Further, different from a customized electrical connection to a heated air delivery tube for power / signal transmission (e.g., a lead frame with electrical contacts), the distal end 9430 may be provided without any lead frame / electrical contacts, i.e., the air adapter tube 9400 is not limited to connecting to an air delivery tube having 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, FPC, antenna, etc. Further, any signal transmission, such as NFC, Bluetooth, etc., may be provided through the antenna. Such an air adapter tube 9400 will provide an agnostic tube configured to be compatible with different patient interfaces and air delivery tubes, i.e., not limited to a specific patient interface, air delivery tube, or system.

[0685] In the illustrated instance, the air adapter tube 9400 is in the form of a short tube, e.g., having a length between about 5 - 15 cm, such as 8.5 - 10 cm. In an alternative instance, the air adapter tube may be in the form of an annular adapter, e.g., in the form of a ferrule or a ring similar in size to the proximal end 9420 (e.g., 1 - 4 cm). Such an annular adapter may include an FPC, one or more sensors, an antenna in the ferrule, and the ferrule is configured for connection between the patient interface and the air delivery tube. As described herein, such an annular adapter may include a power source (e.g., a rechargeable battery), thus allowing such an annular adapter to be agnostically configured to be compatible with different patient interfaces and air delivery tubes.

[0686] 5.5.1 Multi - directional Antenna

[0687] Figures 9A to 9D Shows various configurations of one or more antennas 9100 and one or more tags 9200. Since antennas 9100 and tags 9200 are inductors that are magnetically coupled to each other, antennas 9100 and tags 9200 can be configured within RFID system 9000 to optimize the efficient energy transfer through the magnetic field. For example, antennas 9100 and tags 9200 can be configured to optimize the read distance between antennas 9100 and tags 9200. In a less optimized relative orientation, the read distance may be affected between antennas 9100 and tags 9200.

[0688] Figure 9A Describes a first configuration in which antenna 9100 is oriented substantially parallel to tag 9200. For example, antenna 9100 can be positioned to face tag 9200. This configuration can optimize the magnetic field between antennas 9100 and tags 9200, thereby allowing an increased read distance between antennas 9100 and tags 9200. For example, antennas 9100 and tags 9200 can be spaced further apart from each other and still operate within RFID system 9000. This configuration can be compared with Figure 9B the less optimized second configuration shown.

[0689] Figure 9B Depicts a second configuration in which antennas 9100 and tags 9200 are offset from each other by approximately 90 degrees. Due to the different read angles between antennas 9100 and tags 9200, this second configuration may be less desirable. For example, the ability of antenna 9100 to read tag 9200 from this angle can be reduced at least in part due to the different read angles. Therefore, in this second configuration, the magnetic field between antennas 9100 and tags 9200 may not be optimal. Therefore, compared with Figure 9A the configuration in which, the read distance between antennas 9100 and tags 9200 is reduced in this configuration.

[0690] Therefore, the optimization of the magnetic field between antennas 9100 and tags 9200, and thus the ability of antenna 9100 to read tag 9200 at a given distance, is proportional to the angle at which antennas 9100 and tags 9200 are oriented relative to each other. For example, when the angle between antennas 9100 and tags 9200 is small, the magnetic field between antennas 9100 and tags 9200 can be optimized, as Figure 9A shown. The magnetic field between antennas 9100 and tags 9200 can decrease as antennas 9100 and / or tags 9200 are angled relative to each other, as Figure 9B shown.

[0691] In the context of the above-described system 8000, the angle between the tag 9200 incorporated into the patient interface and the antenna 9100 incorporated into the accessory or air circuit 4170 can depend on many factors. For example, if the antenna 9100 is incorporated into the air circuit 4170, the connection angle of the air circuit 4170 relative to the patient interface 3000 can vary significantly for different types of patient interfaces. As Figure 4P shown, and as described above, a variety of configurations of the patient interface are possible. Additionally, when the air circuit 4170 is coupled to the patient interface 3000, the situation where the tag 9200 is incorporated on the patient interface 3000 can also affect the relative orientation of the tag 9200 and the antenna 9100.

[0692] Figure 9C and Figure 9D The multi-directional antenna configurations shown in can be constructed to compensate for differences in the attachment angle between the air circuit 4170 and the patient interface 3000, and can help enable reading over a wider range of angles, and mitigate one or more of the effects on the reading distance referenced above Figure 9B described. The disclosed multi-angle antenna configurations can be designed to arrange multiple antennas in a three-dimensional shape to create an effective reading orientation between the antenna 9100 and the tag 9200 across a variety of different patient interface types.

[0693] In the Figure 9C configuration shown, two antennas 9100A and 9100B can be angled relative to each other and oriented such that the first antenna 9100A and the second antenna 9100B face different directions. Thus, the first antenna 9100A and the second antenna 9100B are configured to provide reading angles in two directions. Figure 9C The orientation of the tag 9200 in can represent the position of the tag 9200 on the patient interface or accessory, and the orientation of the first antenna 9100A and the second antenna 9100B relative to the tag 9200 can represent the position of the first antenna 9100A and the second antenna 9100B on the air circuit 4170 when connected to the patient interface or accessory. In Figure 9C the configuration shown, the relative orientation of the first antenna 9100A and the second antenna 9100B can be similar to an "8 - shape" to provide a bi - directional reading angle. For example, the first antenna 9100A is configured to provide a first reading angle in a first direction, and the second antenna 9100B is configured to provide a second reading angle in a second direction. The reading directions relative to the tag 9200 are depicted by the Figure 9C arrows shown in. In this way, the tag 9200 can be effectively read from multiple directions. For example, the tag 9200 can be read by the first antenna 9100A or the second antenna 9100B, depending on the position of the tag 9200 relative to the first antenna 9100A and the second antenna 9100B. InFigure 9C In the arrangement, the tag 9200 can be read by the first antenna 9100A because the first antenna 9100A can be an antenna with a reading angle that is more linearly oriented with respect to the tag 9200.

[0694] The first antenna 9100A and the second antenna 9100B can be offset by an angle A with respect to each other. The angle A can be approximately 90 degrees. Alternatively, the angle A can be greater than 90 degrees or less than 90 degrees. For example, the angle A can be from approximately 30 degrees to approximately 120 degrees, or any other suitable angle.

[0695] In some cases, the first antenna 9100A, the second antenna 9100B, and the tag 9200 can be set to a frequency of 13.56 MHz. If the resonant frequency is close to the reader carrier frequency (13.56 MHz), the power transfer between the reader and the tag and the communication distance can be increased. Although the frequency of 13.56 MHz is used as an example, as described above, any other suitable frequency can be used.

[0696] Figure 9D Another multi-directional antenna device is described, which can include additional antennas with a more complex three-dimensional shape. In this configuration, the first antenna 9100A, the second antenna 9100B, the third antenna 9100C, the fourth antenna 9100D, and the fifth antenna 9100E are oriented to provide reading angles in multiple directions. Figure 9D The orientation of the tag 9200 in can indicate the position of the tag 9200 on the patient interface or accessory, and the orientation of the antennas 9100A - 9100E can indicate the position of the antennas 9100A - 9100E on the air circuit 4170 when attached to the patient interface or accessory. Although five antennas are shown, more antennas can be used to increase the number of reading directions, or fewer antennas can be used to reduce the number of reading directions. For example, three, four, six, seven, eight, or more antennas can be used.

[0697] Figure 9D The embodiments of can be applicable to various patient interfaces with various different attachment orientations of the air circuit 4170 with respect to the patient interface 3000 and the tag 9200. Additionally, in some aspects, as described above, the air circuit 4170 can be configured to move or rotate with respect to the patient interface 3000 when connected to the patient interface 3000. For example, there can be a rotary joint or a patient interface connector in the air circuit 4170. Because Figure 9DThe antenna arrangement includes multiple antennas that are oriented to face multiple different directions. Even when the air circuit 4170 moves relative to the patient interface when connected to the patient interface, the tag 9200 can receive a portion of the field emitted by the multi-directional antenna. When the air circuit 4170 moves, different antennas in the multi-directional configuration can be used to read the tag 9200, depending on which antenna is most closely aligned with the tag 9200.

[0698] In some cases, the first antenna 9100A, the second antenna 9100B, the third antenna 9100C, the fourth antenna 9100D, and the fifth antenna 9100E can be set to a frequency of 13.56 MHz. If the resonant frequency is close to the reader carrier frequency (13.56 MHz), the power transfer and communication distance between the reader and the tag can be increased. Although the frequency of 13.56 MHz is used as an example, any other suitable frequency can be used as described above.

[0699] Figures 10A to 10D Multiple configurations between various patient interfaces and air circuits are shown. For example, Figures 9C to 9D The shown configuration of the antenna and the tag can be used to create an effective reading orientation in the Figures 10A to 10D shown configuration.

[0700] For example, Figure 10A The frame 10000 of the nasal cannula patient interface is shown. In some embodiments, the frame 10000 can be used with the patient interface 3000, as Figure 8A and Figure 8B shown. The frame 10000 is configured such that the air circuit 4170 is coupled to the frame 10000, for example, via a joint 10002 at or near the top of the user's head. The air circuit 4170 can be rotatably coupled to the frame 10000 via the joint 10002. The joint 10002 can be a rotary joint, thereby allowing the air circuit 4170 to rotate relative to the frame 10000. As shown, the frame 10000 and the air circuit 4170 are at an angle of approximately 90 degrees to each other. Therefore, the antenna 9100 fixed in or on the proximal portion of the air circuit 4170 can be angled relative to the tag 9200 fixed in or on the frame 10000.

[0701] As described above, the orientation of the antenna 9100 and the tag 9200 may affect the ability of the antenna 9100 to read the tag 9200. Therefore, in the Figure 10A shown configuration, if a single two-dimensional antenna 9100 is used as shown, the reading efficiency between the antenna 9100 and the tag 9200 may be reduced. Using two or more antennas 9100 in the form of multi-dimensional antennas, for example, as Figure 9C and Figure 9DAs shown, the reading efficiency between the antenna 9100 and the tag 9200 can be increased in this configuration. For example, as Figure 9D shown, in this configuration, the first antenna 9100A, the second antenna 9100B, the third antenna 9100C, the fourth antenna 9100D, and / or the fifth antenna 9100E can be used. The use of multiple antennas arranged in a three-dimensional configuration can facilitate the effective reading of the tag 9200, regardless of the orientation of the air circuit 4170 relative to the frame 10000 when connected.

[0702] Figure 10B An alternative configuration between the patient interface 3000 and the air circuit 4170 is shown, for example, a nasal cannula patient interface (according to any of the examples described herein). The air circuit 4170 can be connected to the patient interface through the connector 11000. The connector 11000 can allow the air circuit 4170 to rotate, for example, around the axis X. Depending on how the air circuit 4170 and the patient interface 3000 move relative to each other, the use of a single two-dimensional antenna 9100 as shown may result in a reduction in reading efficiency in some relative configurations. The use of two or more antennas 9100 in the form of multi-dimensional antennas, for example, as Figure 9C and Figure 9D shown, may increase the reading efficiency between the antenna 9100 and the tag 9200. For example, as Figure 9D shown, in this configuration, the first antenna 9100A, the second antenna 9100B, the third antenna 9100C, the fourth antenna 9100D, and / or the fifth antenna 9100E can be used. The use of multiple antennas arranged in a three-dimensional configuration can facilitate the effective reading of the tag 9200, regardless of the orientation of the air circuit 4170 relative to the patient interface 3000.

[0703] Figure 10C and Figure 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 nasal cannula full-face patient interface. The air circuit 4170 can be connected to the patient interface through the connector 12000. The connector 12000 can be a rotary joint, thus allowing the air circuit 4170 to rotate. For example, the connector 12000 can allow rotation around the axis Y of the patient interface 3000, as well as the movement of the air circuit 4170 relative to the patient interface 3000. Figure 10C and Figure 10D depict different positions of the air conduit relative to the patient interface 3000 and the tag 9200, for example, depending on the different positions the patient may be in when wearing the patient interface 3000. When the patient moves during use, the air circuit 4170 may change direction unpredictably. In Figure 10C and Figure 10DIn the positions shown, the antenna 9100 and the tag 9200 can be offset from each other. For example, the antenna 9100 and the tag 9200 can be oriented such that the antenna 9100 and the tag 9200 are angled with respect to each other. As previously mentioned, the angle between the antenna 9100 and the tag 9200 can result in a less optimized reading direction. As described above with reference to Figure 10A and Figure 10B described, using the antenna 9100 in the form of two or more multi-dimensional antennas, for example, as Figure 9C and Figure 9D shown, can increase the reading efficiency between the antenna 9100 and the tag 9200. For example, as Figure 9D shown, in this configuration, a first antenna 9100A, a second antenna 9100B, a third antenna 9100C, a fourth antenna 9100D, and / or a fifth antenna 9100E can be used. Using multiple antennas arranged in a three-dimensional configuration can facilitate the effective reading of the tag 9200, regardless of the orientation of the air circuit 4170 relative to the patient interface 3000 when connected.

[0704] Each embodiment discussed herein can enable a user to detect the identity of the patient interface or accessory being used. In this way, information regarding the patient interface, accessory, patient, or prescribed treatment can be transmitted via RFID. Each embodiment can in particular help increase patient usage and / or patient comfort.

[0705] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed apparatus without departing from the scope of the invention. Considering the specification and practice of the invention disclosed herein, other embodiments of the invention will be apparent to those skilled in the art. The specification and examples are to be considered only as exemplary, and the true scope and spirit of the invention are indicated by the appended claims.

[0706] 5.6 List of Reference Numerals

[0707]

[0708]

[0709]

[0710]

[0711]

[0712]

[0713]

[0714]

[0715]

[0716]

Claims

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

2. An air adapter tube for diagnosing and / or treating respiratory disorders, comprising: A tubular body configured to deliver pressurized therapeutic air between a proximal end and a distal end of the tubular body, the proximal end being configured to connect to a patient interface and the distal end being configured to connect to an air delivery tube; And A sensor configured to generate a signal indicating the sleep position of the patient.

3. An air adapter tube for diagnosing and / or treating respiratory disorders, comprising: A tubular body configured to deliver pressurized therapeutic air between a proximal end and a distal end of the tubular body, the proximal end being configured to connect to a patient interface and the distal end being configured to connect to an air delivery tube; And A sensor configured to generate a signal indicating the respiration and / or biomarker of the gas exhaled by the patient.

4. An air adapter tube for diagnosing and / or treating respiratory disorders, comprising: A proximal end and a distal end, wherein the proximal end is configured to be detachably coupled to a patient interface and the distal end is configured to be detachably coupled to an air delivery tube; A sensor configured to generate a signal based on a sensed physical quantity; and An antenna configured to receive data from an RFID tag.

5. The air adapter tube according to any one of claims 1 and 4, wherein The sensor includes a pressure sensor.

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

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

8. The air adapter tube according to claim 7, wherein, The CO2 sensor is configured to detect CO2 accumulation, rebreathing CO2 level, and / or respiratory comfort.

9. The air adapter tube according to any one of claims 7 to 8, wherein The CO2 sensor is configured to be arranged between the patient and ventilation on the patient interface.

10. The air adapter tube according to any one of claims 7 to 9, wherein, The CO2 sensor is configured to detect end-tidal CO2.

11. The air adapter tube according to any one of claims 5 to 10, wherein, The sensor is a volatile organic compound (VOC) sensor configured to detect biomarkers in the respiration of the patient.

12. The air adapter tube according to claim 11, wherein, The sensor is a CO2 sensor and / or a volatile organic compound (VOC) sensor, and wherein the CO2 sensor and / or the VOC sensor is configured to perform pre-treatment analysis before pressurized therapeutic air is delivered to the patient interface.

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

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

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

16. The air adapter tube according to any one of claims 1 to 15, wherein, The length of the tubular body is between about 8.5 - 10 cm.

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

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

19. The air adapter tube according to any one of claims 1 to 18, wherein The tubular body includes a helix.

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

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

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

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

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

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

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

27. The air adapter tube according to any one of claims 23 to 26, wherein, The flexible printed circuit includes a plurality of linear portions for supporting electronic components and at least one flexible bending portion between the linear portions.

28. The air adapter tube according to claim 27, wherein, One of the electronic components is a pressure sensor, and the other of the electronic components is an accelerometer sensor configured to generate a signal indicating the patient's sleep position.

29. The air adapter tube according to any one of claims 27 to 28, wherein The electronic components include one or more sensors configured to generate a signal representing respiration and / or a biomarker indicating the patient's health.

30. The air adapter tube according to claim 29, wherein, The one or more sensors include a CO2 sensor or a volatile organic compound (VOC) sensor.

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

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

33. The air adapter tube according to claim 32, wherein, The first adapter element includes an outer cylindrical surface having a port, and the sensor projects radially inwardly into and / or through the port.

34. The air adapter tube according to claim 33, further comprising silicone to seal the port adjacent to the sensor.

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

36. The air adapter tube according to any one of claims 32 to 35, further comprising a socket portion connected to the first adapter element, wherein, The first adapter element and the ferrule portion form an annular space configured to receive the flexible printed circuit that supports the sensor.

37. The air adapter tube according to 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. The air adapter tube according to any one of claims 32 to 37 further includes ventilation holes along the periphery of the first adapter element.

39. The air adapter tube according to claim 38 further includes a waterproof pressure balance membrane provided to the ventilation holes and configured to adjust the differential pressure at the proximal end.

40. The air adapter tube according to any one of claims 1 to 39 further includes an electrical connector provided at the distal end of the tubular body, the electrical connector being configured to be electrically connected to a corresponding electrical connector of the hot air delivery tube.

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

42. The air adapter tube according to any one of claims 40 to 41 further includes an indicator or guide adjacent to the distal end, the indicator or guide being configured to align with a corresponding indicator or guide of the hot air delivery tube.

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

44. The air adapter tube according to any one of claims 40 to 43 further includes a mechanical connector provided at the distal end of the tubular body, the mechanical connector being configured to be mechanically connected to a corresponding mechanical connector of the hot air delivery tube.

45. The air adapter tube according to any one of claims 1 to 44 further includes a power source configured to supply power to the sensor and / or the flexible printed circuit.

46. The air adapter tube according to any one of claims 1 to 45 Among them, The sensor includes a plurality of sensors, the plurality of sensors including at least a first sensor, a second sensor, and a third sensor, wherein the first sensor is configured to generate a signal based on the air passing through at the proximal end during treatment for diagnosing and / or treating a respiratory disorder, wherein the second sensor is configured to generate a signal indicating the sleep position of the patient, and wherein the third sensor is configured to generate a signal indicating the respiration of the gas exhaled by the patient and / or a biomarker of the gas exhaled by the patient before the treatment is applied.

47. The air adapter tube according to any one of claims 1 to 46 further includes: a first electrical connector configured to couple a first wire configured to deliver power to the air delivery tube; and a second electrical connector configured to be coupled to a second wire configured to send data to and receive data from the air delivery tube.

48. The air adapter tube according to any one of claims 4 and 24, wherein The antenna is a multi-directional antenna, the multi-directional antenna including a plurality of antennas oriented at different angles relative to each other.

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

50. The air adapter tube according to any one of claims 48 and 49, wherein, The plurality of antennas includes at least a first antenna and a second antenna, wherein the first antenna and the second antenna are oriented at an angle of approximately 30 degrees to approximately 120 degrees relative to each other.

51. The air adapter tube according to any one of claims 48 to 50, wherein, The plurality of antennas is set to a frequency of about 10 MHz to about 12 GHz.

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

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

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

55. 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 the air delivery tube and the patient interface; Generating a signal with the sensor; And Transmitting the signal for diagnosing or treating the patient.

56. 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: Controlling when the sensor is configured to sense a physical quantity.

57. The system according to claim 56, wherein, Controlling the sensor based on the determined patient position.

58. The system according to any one of claims 56 to 57, wherein, The sensor is controlled to sense the physical quantity before positive pressure is delivered to the air adapter tube.

59. The system according to any one of claims 56 to 58, wherein, Based on determining that no positive pressure is being delivered to the air adapter tube, controlling the sensor to sense the physical quantity.

60. 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 changing at least one treatment parameter based on the generated signal of the sensor.

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

62. 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 the flow generator to adjust the generated pressure based on pressure data obtained from a pressure sensor of the air adapter tube.

63. 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 the flow generator to adjust the generated pressure based on data obtained from a CO2 sensor of the air adapter tube.

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

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

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

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

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

69. The air adapter tube according to claim 68, wherein, The second transceiver is a wired transceiver.

70. The air adapter tube according to claim 68, further comprising: A power management system, wherein the second transceiver is further configured to be electrically coupled to a power source external to the air adapter tube and deliver power from the power source to the power management system.

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

72. The air adapter tube according to claim 71, further comprising: A second transceiver configured to send sensor data to another device based on the sensed physical quantity.

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

74. The air adapter tube according to claim 72, wherein, The second transceiver transmits the sensor data to the another device using wireless communication.

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