Devices, systems, and methods for detecting medical devices

Abstract

The catheter headgear may include an opening removably coupled with the air circuit; a first portion extending from the opening to a first proximal end configured to couple with a patient interface; a second portion extending from the opening to a second proximal end configured to couple with a patient interface; a first stretchable accordion portion extending along the first portion; a second stretchable accordion portion extending along the second portion; a first antenna located at a region adjacent to the opening; a second antenna spaced apart from the first antenna; and an electrically conductive electrical connection coupling the first antenna and the second antenna, where the electrical connection extends along at least a portion of the first stretchable accordion portion or the second stretchable accordion portion, and where the electrical connection is configured to accommodate stretching of the first stretchable accordion portion or the second stretchable accordion portion.

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; U.S. Provisional Application No. 63 / 487,311, filed on February 28, 2023; U.S. Provisional Application No. 63 / 487,317, filed on February 28, 2023; and U.S. Provisional Application No. 63 / 515,681, filed on July 26, 2023. The entire content of each of these provisional applications is incorporated herein by reference. Technical Field

[0003] The present technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and improving respiratory - related disorders. The present technology also relates to medical devices or equipment, systems, and their uses. Background Art

[0004] The Human Respiratory System and Its Disorders

[0005] The respiratory system of the body facilitates gas exchange. The nose and mouth form the airway entrance of the patient.

[0006] 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 and carbon dioxide to move in the opposite direction. The trachea divides into the right and left main bronchi, which ultimately further divide 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.

[0007] There is a series of respiratory disorders. Certain disorders can be characterized by specific events, such as apnea, hypopnea, and hyperventilation.

[0008] 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.

[0009] 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 can lead to cardiovascular disease and brain damage. The syndrome is a common disorder, particularly in middle-aged overweight men, although affected individuals may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0010] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller in which there are rhythmic alternating cycles of waxing and waning ventilation called CSR cycles. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Because of the repeated hypoxia, CSR can be potentially harmful. In some patients, CSR is associated with repeated awakenings from sleep, which can lead to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0011] 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.

[0012] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0013] 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.

[0014] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These symptoms include increased resistance to air flow, prolonged expiratory phase of breathing, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (the major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: dyspnea on exertion, chronic cough, and production of sputum.

[0015] Neuromuscular diseases (NMDs) is a broad term encompassing 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, which leads to loss of the ability to walk, wheelchair dependence, difficulty swallowing, weakening of the respiratory muscles, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over 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 disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic dystrophy). Symptoms of respiratory failure in NMDs include increasing general fatigue, difficulty swallowing, dyspnea on exertion and at rest, tiredness, drowsiness, morning headaches, and difficulty concentrating and mood changes.

[0016] Chest wall disorders are a group of thoracic 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, tiredness, poor sleep quality, and loss of appetite.

[0017] A range of therapies have been used to treat or improve such conditions. Additionally, these therapies can be utilized by other healthy individuals to prevent the onset of respiratory disorders. However, these therapies have many drawbacks.

[0018] Therapies

[0019] 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 aforementioned respiratory disorders.

[0020] Respiratory pressure therapy

[0021] 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).

[0022] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, for example, 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.

[0023] Non-invasive ventilation (NIV) provides ventilatory 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 performing some or all of the work of breathing. The ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, which are in the forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0024] Invasive ventilation (IV) provides ventilatory 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.

[0025] Flow therapy

[0026] 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 through an unsealed or open patient interface to the airway inlet at a "therapeutic flow rate" that remains roughly constant throughout the respiratory cycle. This therapeutic flow rate 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 air at the airway inlet improves ventilation efficiency by flushing or washing out the 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.

[0027] Another form of flow therapy is long - term oxygen therapy (LTOT) or supplemental oxygen therapy. A doctor can prescribe a continuous stream of oxygen - enriched air at a specified oxygen concentration (from 21% to 100% of the fraction of oxygen in ambient air) at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.) to be delivered to the patient's airway.

[0028] Supplemental oxygen

[0029] For some patients, oxygen therapy can be combined with respiratory pressure therapy or HFT by adding supplemental oxygen to a pressurized air stream. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplemental oxygen.

[0030] Respiratory therapy system

[0031] 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.

[0032] 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.

[0033] Another form of the therapy system is a mandibular repositioning device.

[0034] Patient interface

[0035] A patient interface can be used to engage respiratory equipment to 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 patient's 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.

[0036] Some other mask systems may not be functionally applicable in the art. 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 configured to prevent water from a higher external pressure from entering but does not maintain the internal air at a pressure above ambient.

[0037] Certain face masks may be clinically disadvantageous for the present technology, for example, in cases where they block airflow through the nose and only allow airflow through the mouth.

[0038] 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 lip of the mouth, these face masks may be uncomfortable or impractical for the present technology.

[0039] Certain face masks may not be suitable for use while sleeping, for example, when the head is lying on its side on a pillow in bed.

[0040] 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 greatly among different 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.

[0041] Due to these challenges, some face masks have one or more problems such as being obtrusive, unaesthetic, expensive, ill-fitting, difficult to use, and uncomfortable, especially when worn for a long time or when the patient is not familiar 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 be uncomfortable when worn for a long time (such as for 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.

[0042] 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 usually advised to clean their face masks regularly, if the face mask is difficult to clean (for example, difficult to assemble or disassemble), the patient may not be able to clean their face mask, which may affect the patient's compliance.

[0043] While face masks for other applications (such as for pilots) may not be suitable for treating sleep apnea, face masks designed for treating sleep apnea may be suitable for other applications.

[0044] For these reasons, patient interfaces for delivering CPAP during sleep form a unique field.

[0045] Seal-forming structure

[0046] 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.

[0047] 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 area and the bridge of the nose area of the face. In one form of the patient interface, the seal-forming structure may include an element that surrounds the mouth area in use, such as by forming a seal over the lower lip area of the face. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the mouth area in use. These different types of patient interfaces may be named by their manufacturers with various names, including nasal masks, full face masks, nasal pillows, nasal pillows, and nasal-oral masks.

[0048] 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 swimming goggles that cover the patient's forehead may not be suitable for use on the patient's nose.

[0049] 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 the mass-produced patient interface, one or both must adapt to form a seal.

[0050] One type of seal-forming structure extends around the periphery of the patient interface and is designed 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 face-to-face. The seal-forming structure may include an air- or fluid-filled pad, 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.

[0051] 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 style 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. In addition, if the shape of the seal-forming structure does not match the shape of the patient, the seal-forming structure may wrinkle or buckle during use, creating a leak.

[0052] Another type of seal-forming structure can include friction fit elements, such as for insertion into the nostrils, however some patients find these elements uncomfortable.

[0053] Another form of seal-forming structure can use an adhesive to achieve a seal. Some patients may find it inconvenient to apply and remove the adhesive to their face regularly.

[0054] A series of patient interface seal-forming structure techniques are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0055] One form of nasal pillows 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 Puritan-Bennett Corporation.

[0056] ResMed Limited has manufactured the following products incorporating nasal pillows: SWIFT™ Nasal Pillow Mask, SWIFT™ II Nasal Pillow Mask, SWIFT™ LT Nasal Pillow Mask, SWIFT™ FX Nasal Pillow Mask, and MIRAGE LIBERTY™ Full Face Mask. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: International Patent Application WO2004 / 073,778 (describing in particular aspects of the ResMed Limited SWIFT™ Nasal Pillow), U.S. Patent Application 2009 / 0044808 (describing in particular aspects of the ResMed Limited SWIFT™ LT Nasal Pillow); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (describing in particular aspects of the ResMed Limited MIRAGE LIBERTY™ Full Face Mask); International Patent Application WO2009 / 052,560 (describing in particular aspects of the ResMed Limited SWIFT™ FX Nasal Pillow).

[0057] Positioning and stabilization

[0058] The seal-forming structure of a patient interface for positive pressure therapy is subject to a corresponding force of 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.

[0059] One technique is the use of adhesives. See, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some individuals.

[0060] Another technique is the use of one or more straps and / or stabilizing bands. Many such bands suffer from one or more of poor fit, bulkiness, discomfort, and inconvenience of use.

[0061] Respiratory Pressure Therapy (RPT) Device

[0062] 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 flow for delivery to an airway interface. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Accordingly, an RPT device can also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0063] 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 with respect to one or more of comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.

[0064] An example of a special requirement of certain RPT devices is acoustic noise.

[0065] Table of noise output levels of existing RPT devices (only one specimen, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0066] RPT Device Name A-Weighted Sound Pressure Level dB(A) Year (approximate) Series C TangoTM 31.9 2007 Series C TangoTM with Humidifier 33.1 2007 S8 EscapeTM II 30.5 2005 S8 EscapeTM II with H4iTM Humidifier 31.1 2005 S9 AutoSetTM 26.5 2010 S9 AutoSetTM with H5i Humidifier 28.6 2010

[0067] A known RPT device for treating sleep apnea is the S9 Sleep Therapy System manufactured by ResMed. Another example of an RPT device is a ventilator. Ventilators, such as the ResMed Stellar™ series for adult and pediatric patients, 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.

[0068] The ResMed Elisée™ 150 ventilator and the ResMed VS III™ ventilator can provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for treating 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 electrically driven blower or a compressed gas reservoir, and are configured to supply an air stream to a patient's airway. In some cases, the air stream 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.

[0069] 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. In addition, comfort and efficacy in certain aspects can be highly sensitive to small subtle changes in one or more parameters.

[0070] Air circuit

[0071] An air circuit is a conduit or tube that is constructed and arranged to allow an air stream 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 can be separate branches for the air circuit for inhalation and exhalation. In other cases, a single-branch air circuit is used for both inhalation and exhalation.

[0072] Humidifier

[0073] Delivering an unhumidified air stream can cause airway dryness. Using a humidifier with an RPT device and a patient interface to produce humidified gas minimizes dryness of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, warm air typically applied to the facial area inside and around the patient interface is more comfortable than cold air.

[0074] A range of artificial humidification devices and systems are known, however they do not meet the special requirements of a medical humidifier.

[0075] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to ambient air when needed, typically while the patient is asleep or resting (e.g., in a hospital). Medical humidifiers placed at the bedside can be small. Medical humidifiers can be configured to humidify and / or heat only the air stream delivered to the patient, without humidifying and / or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, evaporative coolers, etc.), for example, can also humidify the air inhaled by the patient, however these systems also humidify and / or heat the entire room, which can make the occupants uncomfortable. In addition, medical humidifiers can have more stringent safety constraints than industrial humidifiers.

[0076] Although many medical humidifiers are known, they may have one or more disadvantages. Some medical humidifiers may provide inadequate humidification and may be difficult or inconvenient for some patients to use.

[0077] Oxygen source

[0078] Experts in the field have recognized that exercise can bring long-term benefits to patients with respiratory failure, which slows the progression of the disease, improves the quality of life and prolongs the life of patients. However, most fixed forms of exercise, such as treadmills and stationary bicycles, are too strenuous for these patients. Therefore, people have long recognized the need for mobility. Until recently, such mobility has been achieved through the use of small compressed oxygen tanks or oxygen cylinders mounted on carts with push wheels. The disadvantages of these oxygen tanks are that they contain a limited amount of oxygen and are heavy, weighing about 50 pounds when installed.

[0079] Oxygen concentrators have been used for about 50 years to supply oxygen for respiratory therapy. Traditional oxygen concentrators are large and cumbersome, making them difficult and impractical to use for ordinary ambulatory 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. In order to make these devices small and easy to move, the various systems required to produce oxygen-enriched gas are compressed. POCs seek to use the oxygen they produce as efficiently as possible to minimize weight, size, and power consumption. This can be achieved by delivering oxygen in a series of pulses, with each pulse or "bolus" timed to coincide with the start of inspiration. This mode of therapy is called pulsed oxygen delivery (POD) or demand mode, as opposed to traditional continuous flow delivery that is more suitable for stationary oxygen concentrators.

[0080] Data Management

[0081] There may be clinical reasons for obtaining data to determine whether a patient receiving respiratory therapy is "compliant", such as the patient having 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 the 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 the RPT device, such as a healthcare provider, can manually obtain data describing the patient's therapy using the RPT device, calculate the use 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 compliance.

[0082] Transmitting therapy data to a third party or external system may be beneficial for other aspects of patient therapy.

[0083] Existing processes for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0084] Vent port technology

[0085] Some forms of treatment systems can include a vent to allow flushing of exhaled carbon dioxide. The vent can allow gas to flow from the internal space of the patient interface (e.g., the inflation chamber) to the external space of the patient interface, such as to the environment.

[0086] The vent can include an aperture and gas can flow through the aperture during use of the mask. Many such vents are noisy. Others may become blocked during use, providing inadequate flushing. Some vents can interfere with the sleep of the patient 1000's bed partner 1100, for example, through noise or a concentrated airflow.

[0087] ResMed Limited has developed a number of improved mask vent technologies. See International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0088] Noise table of existing masks (ISO 17510-2:2007, pressure of 10 cmH2O at 1 m)

[0089] Mask Name Mask Type A-Weighted Sound Power Level dB(A) (Uncertainty) A-Weighted Sound Pressure dB(A) (Uncertainty) Year (approximate) Glue-on (*) Nasal 50.9 42.9 1981 ResMed Standard (*) Nasal 31.5 23.5 1993 ResMed MirageTM (*) Nasal 29.5 21.5 1998 ResMed UltraMirageTM Nasal 36 (3) 28 (3) 2000 ResMed Mirage ActivaTM Nasal 32 (3) 24 (3) 2002 ResMed Mirage MicroTM Nasal 30 (3) 22 (3) 2008 ResMed MirageTM SoftGel Nasal 29 (3) 22 (3) 2008 ResMed MirageTM FX Nasal 26 (3) 18 (3) 2010 ResMed Mirage SwiftTM (*) Nasal Pillow 37 29 2004 ResMed Mirage SwiftTM II Nasal Pillow 28 (3) 20 (3) 2005 ResMed Mirage SwiftTM LT Nasal Pillow 25 (3) 17 (3) 2008 ResMed AirFit P10 Nasal Pillow 21 (3) 13 (3) 2014

[0090] (*Only one sample, measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744)

[0091] The sound pressure values of various objects are listed below:

[0092] Object A-Weighted Sound Pressure dB(A) Note Vacuum Cleaner: Nilfisk Walter Broadly Litter Hog: B+ Grade 68 ISO 3744, at a distance of 1 m Conversation Speech 60 At a distance of 1 m Ordinary Residence 50 Quiet Library 40 Quiet Bedroom at Night 30 Background of TV Studio 20

[0093] Screening, diagnosis, and monitoring system

[0094] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary disorders and usually involves clinical experts to apply the system. PSG typically involves placing 15 to 20 contact sensors on a patient to record various body signals such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep apnea disorder involves observing a patient in a clinic for two nights, one night for pure diagnosis and the second night for a clinician to titrate treatment parameters. Thus, PSG is both expensive and inconvenient. In particular, it is not suitable for screening / diagnosing / monitoring sleep apnea disorder at home.

[0095] 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.

[0096] Clinical experts may be able to adequately screen, diagnose, or monitor a patient 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 a patient's disorder. In addition, a given clinical expert may apply different criteria at different times. Summary of the Invention

[0097] 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.

[0098] A first aspect of the present technology relates to devices for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0099] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0100] 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.

[0101] One form of the present technology includes a positioning and stabilizing structure configured to provide a force to hold a seal-forming structure in a therapeutically effective position on a patient's head. The positioning and stabilizing structure includes at least one strap.

[0102] One form of the present technology includes a patient interface that includes an inflatable chamber, a seal-forming structure, and a positioning and stabilizing structure.

[0103] 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 sized and configured to receive an airflow at the therapeutic pressure for a patient to breathe. The patient interface also includes a seal-forming structure configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet. The seal-forming structure has holes therein such that an airflow at the therapeutic pressure is delivered at least to the inlets of the patient's nostrils. The seal-forming structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use. The patient interface also includes a positioning and stabilizing structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

[0104] 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.

[0105] In one form, each modular element has at least two versions or styles. These versions or styles can be used interchangeably with one another to form different modular components.

[0106] One form of the present technology includes a catheter headgear that includes: an opening configured to removably couple to an air circuit; a first portion extending from the opening to a first proximal end, wherein the first proximal end is configured to couple to a patient interface; a second portion extending from the opening to a second proximal end, wherein the second proximal end is configured to couple to the patient interface; a first stretchable bellows portion extending along a length of the first portion; a second stretchable bellows portion extending along a length of the second portion; a first antenna located in a region adjacent to the opening; a second antenna spaced apart from the first antenna; and a conductive electrical connection coupling the first antenna and the second antenna, wherein the electrical connection extends along at least a portion of the first stretchable bellows portion or the second stretchable bellows portion, and wherein the electrical connection is configured to accommodate stretching of the first stretchable bellows portion or the second stretchable bellows portion.

[0107] In one aspect of the present technology, the second antenna can be located in a region adjacent to the first proximal end or the second proximal end.

[0108] In another aspect, the electrical connection has a serpentine or zigzag path at least where the electrical connection extends along at least a portion of the first stretchable bellows section or the second stretchable bellows section.

[0109] In another aspect, the electrical connection can be formed of a wire or a stretchable material.

[0110] In some forms, the electrical connection can be located on the outer surface of the first part or the second part.

[0111] In at least one form, the electrical connection can be located within the wall of the first part or the second part.

[0112] In various aspects, the electrical connection can be incorporated as part of a sleeve covering at least one of the first part or the second part.

[0113] In one aspect of the present technology, the sleeve can be formed of a stretchable textile material.

[0114] In form, the electrical connection can be in the form of a conductive trace, a conductive wire, or a metal gel.

[0115] In various aspects of the present technology, the electrical connection can be printed, thermally bonded, or stitched onto the sleeve.

[0116] In some aspects, the electrical connection can be a stretchable conductive silicone or wire printed or thermally bonded to the outer surface of the first part or the second part.

[0117] In a further aspect, the first antenna can surround an opening.

[0118] In another form of the present technology, the catheter headgear can include: an opening configured to be removably coupled to an air circuit; a first part extending from the opening to a first proximal end, wherein the first proximal end is configured to be coupled to a patient interface; a second part extending from the opening to a second proximal end, wherein the second proximal end is configured to be coupled to the patient interface; a first stretchable bellows section extending along the length of the first part; a second stretchable bellows section extending along the length of the second part; a first antenna located in a region adjacent to the opening; a second antenna spaced apart from the first antenna; and a sleeve covering at least one of the first part or the second part, wherein the sleeve includes a conductive electrical connection extending along the sleeve and electrically coupling the first antenna and the second antenna.

[0119] In various aspects of the present technology, the sleeve may be formed of stretchable textile material.

[0120] In form, the sleeve may be thermally bonded to the outer surface of at least one of the first part or the second part.

[0121] In another form, at least one of the first antenna or the second antenna may be incorporated as part of the sleeve.

[0122] In other forms, the sleeve may be removably coupled to the first part or the second part.

[0123] In various aspects, the sleeve may cover the first part and the second part.

[0124] In some forms, the second antenna may be located in a region adjacent to the first proximal end or the second proximal end.

[0125] Another form of the present technology may include a catheter headgear that includes: an opening configured to be removably coupled to an air circuit; a first part extending from the opening to a first proximal end, where the first proximal end is configured to be coupled to a patient interface; a second part extending from the opening to a second proximal end, where the second proximal end is configured to be coupled to the patient interface; a first stretchable bellows part extending along the length of the first part; a second stretchable bellows part extending along the length of the second part; a first antenna located in a region adjacent to the opening; a second antenna spaced apart from the first antenna; and a stretchable conductive electrical connection electrically coupling the first antenna and the second antenna, where the electrical connection extends along at least a portion of the first stretchable bellows part or the second stretchable bellows part.

[0126] In one form, the electrical connection may be formed of conductive silicone.

[0127] In another form, the electrical connection may be in the form of a wire or a conductor.

[0128] In various aspects, the electrical connection may be printed or thermally bonded on the outer surface of the first part or the second part.

[0129] Another form of the technology may include a conduit that includes a portion configured to extend from a distal end to a proximal end, a stretchable bellows portion configured to extend along a length of the portion, and a stretchable conductor configured to extend along at least a portion of the stretchable bellows portion. In an example, the distal end is configured to couple to an air circuit. In an example, the proximal end is configured to couple to a patient interface. In an example, the conduit further includes a first antenna and a second antenna spaced apart from the first antenna, wherein the stretchable conductor is configured to electrically couple the first antenna and the second antenna.

[0130] The described methods, systems, devices, and apparatuses may be implemented to improve the functionality of a processor, such as a processor of a dedicated computer, a respiratory monitor, and / or a respiratory therapy device. Additionally, the described methods, systems, devices, and apparatuses may provide improvements in the technical field of the automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep disordered breathing.

[0131] Of course, portions of these aspects may form sub - aspects of the technology. Additionally, the sub - aspects and / or the individual aspects within the aspects may be combined in various ways and also form additional aspects or sub - aspects of the technology.

[0132] Other features of the technology will become apparent by considering the information contained in the following detailed description, the abstract, the drawings, and the claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0133] The technology is illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like reference numerals refer to similar elements and include:

[0134] Figures 1A to 1C Each illustrates various configurations of a respiratory therapy system in use.

[0135] Figure 2 Shows a patient interface in the form of a nasal mask according to one form of the technology.

[0136] Figure 3A Is a schematic diagram of the pneumatic path of an RPT device according to one form of the 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 given moment. Items within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0137] Figure 3B Is a schematic diagram of the electronic components of an RPT device according to one form of the technology.

[0138] Figure 3CSchematic diagram of an algorithm implemented in an RPT device according to one form of the present technology.

[0139] Figure 4A Perspective view of a gasket of a patient interface configured to be worn by a patient and deliver pressurized air to the patient's nose and mouth.

[0140] Figure 4B Perspective view of a gasket of a patient interface configured to be worn by a patient and deliver pressurized air to the patient's nose.

[0141] Figure 4C Shows a tube that can be used with Figure 4A 's gasket or Figure 4B 's gasket. Perspective view of the tube.

[0142] Figure 4D Shows a stiffener arm that can be used with Figure 4A 's gasket or Figure 4B 's gasket. Perspective view of the stiffener arm.

[0143] Figure 4E Shows a headgear strap that can be used with Figure 4A 's gasket. Perspective view of the headgear strap.

[0144] Figure 4F Shows a headgear strap that can be used with Figure 4B 's gasket. Perspective view of the headgear strap.

[0145] Figure 4G Shows a front view of a pair of sleeves removably assembled to Figure 4C 's tube or Figure 4D 's stiffener arm.

[0146] Figure 4H Shows a front view of a complete sleeve removably assembled to Figure 4D 's stiffener arm.

[0147] Figure 4I Shows a front perspective view of another alternative form of a complete sleeve removably assembled to Figure 4D 's stiffener arm.

[0148] Figure 4J Is a front view of a patient wearing a gasket of Figure 4C connected to a tube, Figure 4E connected to a headgear strap, and Figure 4G connected to a sleeve of Figure 4A

[0149] Figure 4K Is a front view of a patient wearing a stiffener arm of Figure 4D connected to a headgear strap of Figure 4E and a sleeve of Figure 4H ​Figure 4A Front view of a patient with a gasket.

[0150] Figure 4L is worn connected to Figure 4C the catheter headgear and Figure 4F the headgear strap of Figure 4B Front view of a patient with a gasket.

[0151] Figure 4M is worn connected to Figure 4D the stiffener arm, Figure 4F the headgear strap and Figure 4I the sleeve of Figure 4B Front view of a patient with a gasket.

[0152] Figure 4N is Figure 4L An exploded perspective view of a vent.

[0153] Figure 4O is Figure 4M An exploded perspective view of a part of an air circuit.

[0154] Figure 4P A schematic diagram illustrating possible combinations of patient interfaces.

[0155] Figure 5A A schematic diagram of a medical system according to aspects of the present disclosure.

[0156] Figure 5B A schematic diagram of a medical system according to aspects of the present disclosure.

[0157] Figure 6 A perspective view of an exemplary embodiment according to aspects of the present disclosure.

[0158] Figure 7 A perspective view of an exemplary embodiment according to aspects of the present disclosure.

[0159] Figure 8 A schematic illustration of an exemplary configuration of an antenna and a tag in use according to aspects of the present disclosure. Detailed Description

[0160] Before describing the technology in more detail, it should be understood that the technology is not limited to the specific examples that can vary as described herein. It should also be understood that the terms used in this disclosure are for the purpose of describing only the specific examples discussed herein and are not intended to be limiting.

[0161] The following description is provided with respect to various instances that may share one or more common characteristics and / or features. It should be understood that one or more features of any one instance may be combined with one or more features of another instance or other instances. Additionally, any single feature or combination of features in any one instance may constitute additional instances.

[0162] Reference will now be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numerals are used in all the drawings to refer to the same or like parts. The term "distal" refers to the part that is furthest from the user (e.g., the patient). In contrast, the term "proximal" refers to the part that is closest to the user.

[0163] The foregoing general description and the following detailed description are exemplary and explanatory only and are not limitations of the claimed features. As used herein, the terms "comprises", "comprising", "having", "including", or other variants thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus. In the present disclosure, relative terms such as, for example, "about", "substantially", "generally", and "approximately" are used to indicate a possible variation of ±10% of the stated value or feature.

[0164] Therapy

[0165] In one form, the present technology includes a method for treating a respiratory disorder, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0166] In certain instances of the present technology, a supply of positive pressure air is provided to the nasal passages of the patient via one or both nostrils.

[0167] In certain instances of the present technology, mouth breathing is restricted, constrained, or prevented.

[0168] Respiratory therapy system

[0169] In one form, the present technology includes a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may include an RPT device 4000 for supplying an air stream to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0170] Figure 1AA respiratory therapy system is shown, which includes a patient 1000 who wears a patient interface 3000 in the form of nasal pillows and receives a positive pressure air supply 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 an air circuit 4170. A bed partner 1100 is also shown. The patient sleeps in a supine sleeping position.

[0171] Figure 1B An alternative configuration of the respiratory therapy system is shown, which includes a patient 1000 who wears a patient interface 3000 in the form of a nasal mask and receives 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 an air circuit 4170.

[0172] Figure 1C Another alternative configuration of the respiratory therapy system is shown, which includes a patient 1000 who wears a patient interface 3000 in the form of a full face mask and receives 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 an air circuit 4170. The patient sleeps in a lateral sleeping position.

[0173] 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's airway, such as for treating one or more of the respiratory conditions described elsewhere in this document.

[0174] In one form, the RPT device 4000 is constructed and arranged to be able to deliver an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0175] 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 relative to, for example, the air circuit 4170 or other aspects of the respiratory therapy system can vary throughout use.

[0176] Patient interface

[0177] According to one aspect of the present technology, such as Figure 2The non-invasive patient interface 3000 shown includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilization structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the patient's airway inlet so as to maintain positive pressure at the patient 1000's airway inlet. Accordingly, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0178] Inflatable chamber

[0179] The inflatable chamber 3200 has a perimeter that is shaped to complement the surface profile of an average person's face in the area that will form a seal in use. In use, the bounding edge of the inflatable chamber 3200 is positioned against an adjacent surface of the face. The 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.

[0180] In certain forms of the present technology, the inflatable chamber 3200 does not cover the patient's eyes in use. In other words, the 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.

[0181] In certain forms of the present technology, the inflatable chamber 3200 is constructed of a transparent material such as transparent polycarbonate. Using a transparent material can reduce the obtrusiveness of the patient interface and can help improve compliance with the therapy. Using a transparent material can help the clinician observe how the patient interface is positioned and functions.

[0182] In certain forms of the present technology, the inflatable chamber 3200 is constructed of a translucent material. Using a translucent material can reduce the obtrusiveness of the patient interface and can help improve compliance with the therapy.

[0183] In some forms, the inflatable chamber 3200 is constructed of a rigid material such as polycarbonate. The rigid material can provide support for the seal-forming structure.

[0184] 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 then be formed of a material having a Young's modulus of 0.4 Gpa or less, such as foam. In some forms of the 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 technology, the inflatable chamber 3200 can be made of a material having a Young's modulus of 0.4 Mpa or less, such as between 0.4 Mpa and 0.3 Mpa. An example of such a material is silicone.

[0185] Multiple openings

[0186] Such as Figure 4A And Figure 4B As shown, different inflatable chambers 3200-1, 3200-2 can be formed as part of multi-opening gaskets 3050-1, 3050-2. In the illustrated example, each of the gaskets 3050-1, 3050-2 includes three openings, although alternative gaskets can be formed with more or fewer openings.

[0187] In some forms, the different openings can provide different functions. For example, some openings can be only inlet openings, while other openings can be only outlet openings.

[0188] 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.

[0189] The multiple openings can allow for multiple configurations for delivering air to the inflatable chambers 3200-1, 3200-2. For example, depending on patient needs and / or patient comfort, a patient can use a given gasket 3050-1, 3050-2 in an "upper tube" configuration (e.g., using the catheter headgear described below) or a "lower tube" configuration (e.g., using a single catheter in front of the patient's face).

[0190] Nose and mouth mask

[0191] Such as Figure 4A As 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 inlet ports 3254-1 can be disposed on opposite sides (e.g., left and right sides) of the inflatable chamber 3200-1.

[0192] In some forms, the inflatable chamber 3200-1 can also include at least one ventilation opening 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 opening 3402-1 can be provided between the inflation chamber inlet ports 3254-1.

[0193] 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 inlet ports 3254-1. Each groove 3266-1 can form a partially recessed surface.

[0194] Only nasal mask

[0195] The inflation chamber 3200-2 of only the nasal cushion 3050-2 can be similar to the inflation chamber 3200-1 of the mouth and nasal cushion 3050-1. Only some similarities and differences between the inflation chambers 3200-1 and 3200-2 are described below.

[0196] 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 inlet ports 3254-2 can be provided on opposite sides of the inflation chamber 3200-2 (e.g., left and right sides).

[0197] In some forms, the inflation chamber 3200-2 can also include at least one ventilation opening 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 opening 3402-2 can be provided between the inflation chamber inlet ports 3254-2.

[0198] 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 inlet ports 3254-2. Each groove 3266-2 can form a partially recessed surface.

[0199] Positioning and stabilizing structure

[0200] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of disturbing forces on the patient interface 3000, such as those from tube resistance or accidental interference with the patient interface.

[0201] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured to conform to the manner in which a patient wears it while sleeping. In one example, 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 example, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0202] 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 in a supine sleeping position, where the posterior region of the patient's head is on the pillow.

[0203] 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 in a lateral sleeping position, where the lateral region of the patient's head is on the pillow.

[0204] 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.

[0205] In one form of the present technology, the positioning and stabilization structure 3300 includes a strap constructed of 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.

[0206] 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 the guiding force causes the seal-forming structure to be in sealing contact with a portion of the patient's face. In an example, the strap can be configured as a tie.

[0207] 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.

[0208] In one form of the present technology applicable to a nasal mask only or to a full face mask, the positioning and stabilization structure includes a second strap configured and arranged such that in use 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.

[0209] In one form of the present technology applicable to a nasal mask only or to a full face mask, the positioning and stabilization structure includes a third strap configured and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.

[0210] In certain forms of the present technology, the positioning and stabilization 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.

[0211] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a strap configured to be breathable to allow moisture to be transmitted through the strap.

[0212] In certain forms of the present technology, a system including more than one positioning and stabilization structure 3300 is provided, each positioning and stabilization structure 3300 being configured to provide a holding force corresponding to a different size and / or shape range. For example, the system may include one form of the positioning and stabilization structure 3300 suitable for a large-sized head but not for a small-sized head, and another form suitable for a small-sized head but not for a large-sized head.

[0213] Catheter headgear

[0214] Catheter head sleeve

[0215] In some forms of the present technology, the positioning and stabilization structure 3300 includes one or more head sleeves 3350 that deliver 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 inflation chamber 3200 and the seal forming structure 3100. In Figure 4J In the illustrated form of the present technology, the positioning and stabilization structure 3300 includes two tubes 3350 that deliver 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) in use. This allows a catheter of the air circuit 4170 providing a pressurized air flow to be connected to a connection port 3600 of the patient interface, which connection port 3600 is in a position other than the front of the patient's face, such as on top of the patient's head.

[0216] In Figure 4JIn the form of the present technology shown in the figure, the positioning and stabilization structure 3300 includes two tubes 3350. Each tube 3350 is positioned on a different side of the patient's head during use and extends across the corresponding cheek region above the respective ear (above the back of the ear above the patient's head) to a elbow tube 3610 at the top of the patient 1000's head. This form of the technology 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 this technology, the patient interface 3000 may include a different number of tubes, such as one tube, or two or more tubes.

[0217] 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 during 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 during use (e.g., across another region) to help fix the patient interface 3000 to the patient's head. For example, the tube 3350 and the strap may each be under tension during use to help maintain the seal-forming structure 3100 in the sealed position.

[0218] 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 in the middle.

[0219] In Figure 4J In the form of the technology shown, the two tubes 3350 are fluidly connected to each other at the upper ends and are fluidly connected to the 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 during use, e.g., for cleaning or storage. In the case of using separate tubes, they can be indirectly connected together, e.g., each can be connected to a T-shaped connector. The T-shaped connector can have two arms / branches, and each arm / branch can be fluidly connected to one of the corresponding tubes 3350. Additionally, the T-shaped connector can have a third arm or opening, and the third arm or opening provides a connection port 3600 for fluidly connecting to the air circuit 4170 during use. The opening can be an inlet 3332 for receiving a pressurized air flow (see, for example, 4C).

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

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

[0222] 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.

[0223] 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.

[0224] In some forms, at least one arm of the T-shaped connector (or Y-shaped connector) can be at least partially rigidified. This can help maintain the shape of the connector such that the bending of the connector does not block the air flow path.

[0225] 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 not present. The shape of the tube 3350 can generally be arcuate or curved and approximate the contour of the patient's head between the top of the head and the nasal or oral region.

[0226] 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.

[0227] Each tube 3350 can be configured to receive an air flow from a connection port 3600 on top of the patient's head and deliver the air flow to a seal-forming structure 3100 at the entrance of the patient's airway. Figure 4JIn the illustrated example, each tube 3350 is, in use, positioned on a path extending from the plenum chamber 3200 across the patient's cheek area and above the patient's ear to the elbow tube 3610. For example, a portion of each tube 3350 near the plenum chamber 3200 may, in use, overlie the maxilla region of the patient's head. Another portion of each tube 3350 may overlie a region of the patient's head that is above the supra-aural base point of the patient's head. Each of the tubes 3350 may also be positioned over any one or both of the patient's sphenoid and / or temporal bones and the patient's frontal and parietal bones. The elbow tube 3610 may, in use, be positioned over the patient's parietal bone, over the patient's frontal bone, and / or over the junction therebetween (e.g., the coronal suture).

[0228] 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 across 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 the upper portion of the patient interface 3000 (e.g., the connection port 3600) relative to the lower portion of the patient interface 3000 (e.g., the plenum chamber 3200). That is, the connection port 3600 can be at least partially decoupled from the plenum 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).

[0229] 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 cushion that is typically positioned below the nose and seals to the lower periphery of the nose (e.g., a cushion below the nose). The positioning and stabilization structure 3300 including the tubes 3350 can be constructed and arranged to pull the seal forming structure 3100 below the nose into the patient's face with a sealing force in a posterior and upward direction (e.g., a posterior-superior direction). A sealing force having a posterior-superior 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 above the patient's lips.

[0230] Extensible and non-extensible tube portions

[0231] In some examples of the present technology, one or both of the tubes 3350 are non-extensible in length. However, in some forms, the tubes 3350 may include one or more extensible tube segments, such as formed by an extensible bellows structure. In some forms, the patient interface 3000 may include a positioning and stabilization structure 3300 that includes at least one gas delivery tube having a wall with an extensible bellows structure.Figure 4J The patient interface 3000-1 shown in Figure 4J includes a tube 3350, the upper portion of the tube 3350 including an extensible tube section, each tube section being in the form of an extensible bellows structure 3328-1. In the illustrated example, the upper portion of each tube 3350 includes an extensible bellows structure 3328-1. In an alternative example, the upper portion of the tube 3350 may not include an extensible bellows structure 3328-1.

[0232] In some forms, the extensible bellows structure 3328 (e.g., see Figure 4J and Figure 4L ) may be formed as a series of ridges and grooves on the surface of the tube 3350. The bellows structure 3328 may be biased towards a collapsed position and may move to an expanded position when the patient dons the positioning and stabilization structure 3300. Since portions of the tube 3350 may be substantially inextensible (e.g., inextensible tube section 3363), the bellows structure 3328 allows the positioning and stabilization structure 3300 to stretch to conform to different sized heads. This may allow a single sized tube 3350 to be used with multiple sized heads. For example, as a result of the bellows structure 3328, the positioning and stabilization structure 3300 may be "one size fits all". Alternatively, the tube 3350 may be manufactured in multiple sizes (e.g., small, medium, large). The patient may select the length that most closely matches their head and the bellows structure 3328 may make minor adjustments to conform to an individual patient.

[0233] In some forms, an inlet 3332 may be provided in the middle of the conduit 6320. For example, the tube 3350 may be symmetric about the inlet 3332 by at least one axis.

[0234] The cross-sectional shape of the inextensible tube section 3363 of the tube 3350 may be circular, oval, ovoid, D-shaped, or rounded rectangular, e.g., as described in U.S. Patent No. 6,044,844. A cross-sectional shape presenting a flattened surface of the tube on the side facing and contacting other parts of the patient's face or head may be more comfortably worn compared to, for example, a tube having a circular cross-section.

[0235] ​​​​In some examples of the present technology, a non-extendable tube section 3363 is connected to the inflatable chamber 3200 at a low angle. The head sleeve 3350 can extend downward along both sides of the patient's head and then bend forward and medially 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 project 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 cheekbones, which can be more comfortable than contacting on the patient's cheekbones and can avoid overly obscuring the patient's peripheral vision.

[0236] Catheter headgear connection port

[0237] In some forms of the present technology, the patient interface 3000 can include a connection port 3600 located near the upper, lateral, or posterior portion of the patient's head. For example, in Figure 4J the illustrated form of the present technology, the connection port 3600 is located at the top of the patient's head (e.g., in an upper position relative to the patient's head). In this example, the patient interface 3000 includes an elbow 3610 that forms the connection port 3600. The elbow 3610 can be configured to be fluidly connected to 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 disconnect 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.

[0238] A patient interface having a connection port that is not positioned in front of the patient's face may be advantageous because some patients may find a conduit connected to a patient interface positioned in front of the patient's face to be unaesthetic and / or obtrusive. For example, a conduit connected to a patient interface positioned in front of the patient's face may be prone to snagging on bedding, especially if the conduit extends downward from the patient interface during use. Forms of the present technology that include a patient interface having a connection port positioned above the patient's head during use may make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: a side-lying position, a supine position (e.g., on their back, typically facing upward), or a prone position (e.g., on their front, typically facing downward). Additionally, connecting a conduit to the front portion of a patient interface may exacerbate a problem called tube drag, where during movement of the patient's head or the conduit, the conduit exerts an unwanted 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).

[0239] Head cannula fluid connection

[0240] Two tubes 3350 are fluidly connected to the inflation 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 a textile material, and the lower end of each silicone tube 3350 is overmolded to a rigid connector made of, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector on each tube 3350 may include a concave mating feature configured to connect to a convex mating feature on the inflation chamber 3200. Alternatively, the rigid connector on each tube 3350 may include a convex mating feature configured to connect to a concave mating feature 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).

[0241] 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 sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange can be pushed against the junction between the tube and the circumferential surface of the port or connector surrounding the plenum chamber 3200 to form or enhance the seal between the tube 3350 and the plenum chamber 3200.

[0242] Headgear strap

[0243] In some forms, the positioning and stabilization 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).

[0244] 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 textile can be flexible to conform to various facial profiles. Although the textile can include stiffeners along selected lengths, this can limit the bending, flexing, and / or stretching of the headgear 3302.

[0245] 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 the 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.

[0246] Two forms of the headgear, a four-point headgear 3302-1 and a two-point headgear 3302-2 are discussed in more detail below as illustrative examples.

[0247] Four-point connection

[0248] 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 the inflation chamber 3200, to the frame of the inflation chamber 3200, and / or to four separate locations on the arms of the inflation chamber 3200. The headgear 3302-1 can include four different straps that provide tension to help maintain the seal-forming structure 3100 in the sealed position.

[0249] In some forms, the headgear 3302-1 can include a lower strap 3304-1 that can be connected to a lower portion of the gasket 3050-1. The lower strap 3304-1 can extend along the patient's cheek towards the rear 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 may contact the patient's head below the patient's ear. The lower straps 3304-1 can meet at the rear of the patient's head and can cover the occipital bone and / or the trapezius muscle.

[0250] The headgear 3302-1 can also include an upper strap 3305-1 that 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 docking with the tab 3320).

[0251] A rear strap 3307-1 can extend between the upper strap 3305-1 and the lower strap 3304-1. The lower strap 3304-1 and the upper strap 3305-1 on a given side (e.g., left or right) are also connected to adjacent rear straps 3307-1. 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. In use, the rear strap 3307-1 can cover the occipital bone and / or the parietal bone. This can allow the rear strap 3307-1 to help anchor the headgear 3302-1 to the patient's head.

[0252] 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.

[0253] 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 so 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 inflation chamber 3200, but the length of the lower strap 3304-1 can be unaffected.

[0254] 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.

[0255] In some forms, the headgear 3302-1 can be used only with the nose and mouth cushion 3050-1 (e.g., because the nose cushion 3050-1 alone does not have four connection points). However, the headgear 3302-1 can be used interchangeably with the tube 3350 and the stiffener arm 3340.

[0256] Two-point connection

[0257] 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.

[0258] 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 connected (e.g., sewn) together. This can be comfortable for the patient as they will not come into contact with any seams or joints connecting different straps. In other forms, the headgear 3302-2 can be formed from multiple straps (e.g., two upper straps, a rear strap, etc.) connected together (e.g., by sewing, ultrasonic welding, etc.).

[0259] 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 this 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. For example, the rear strap 3307-2 can be referred to as a backstrap or a rear headgear strap. The rear strap 3307-2 can cover the temporal bone, the parietal bone, and / or the occipital bone. In other instances of the present technology, one or more additional straps can be provided. For example, a patient interface 3000 with a nose and mouth cushion according to an example of the present technology can have a second lower strap configured to abut against the patient's head near the patient's neck and / or against the posterior surface of the patient's neck.

[0260] 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 portion of the patient's head) can be wider than the peripheral portion of the headgear 3302-2. The middle section 3308-2 of the rear strap 3307-2 can include a slit 3309-2. Thus, due to the slit 3309-2, the upper section of the rear strap 3307-2 can move relative to the lower section. 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).

[0261] In some forms, the headgear 3302-2 can be used only with the nasal cushion 3050-2 (e.g., because the nasal and mouth cushion 3050-1 does not have four attachment points). However, the headgear 3302-2 can be used interchangeably with the tube 3350 and the stiffener arm 3340.

[0262] Stiffener arm

[0263] As Figure 4D shown, the stiffener arm 3340 can be an elongated rigid member that helps hold the cushion (e.g., the nasal and mouth cushion 3050-1 or the nasal cushion 3050-2) in the operative position. The stiffener 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.

[0264] In some forms, the stiffener arm 3340 is made of a rigid material (e.g., plastic). The rigid material may not allow the stiffener arm 3340 to stretch.

[0265] In some forms, the stiffener arm 3340 can be flexible in at least one direction. For example, the stiffener arm 3340 can be flexible about its width and can be non-bendable along its length. In other words, the stiffener arm 3340 can bend about an axis along the width of the stiffener arm 3340, but may not be able to bend about an axis perpendicular to the stiffener arm 3340. This can allow an individual patient to adjust the stiffener arm 3340 for a better fit to their individual head.

[0266] In certain forms, the stiffener arm 3340 can remain in a new position after being bent. This can allow the patient to adjust the shape of the stiffener arm 3340 for their specific head, and then the stiffener arm 3340 will maintain the desired shape during use to improve patient comfort.

[0267] In some forms, the first end 3342 of the stiffener arm 3340 can be a free end, and the second end 3344 of the stiffener arm 3340 (e.g., opposite the first end 3342) can be fixed. The first end 3342 can be curved to minimize sharp edges that could 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.

[0268] 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 fit into a groove (e.g., 3266-1 or 3266-2) and connect to the inflation chamber inlet port 3254. The arm connection structure 3504 can be connected to the nose and mouth cushion 3050-1 or the nose-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.).

[0269] In some forms, the arm connection structure 3504 can act as a plug for the inflation chamber inlet port 3254 (e.g., 3254-1 and / or 3254-2). Unlike the tube 3350, the stiffener arm 3340 does not deliver pressurized air to the inflation chamber 3200. The stiffener arm 3340 can be used with a "down-tube" configuration where a hose is connected to the vent opening 3402 (e.g., 3402-1 and / or 3402-2), and air is delivered into the inflation chamber 3200 through the vent opening 3402. In this example, air does not need to travel to or from 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.

[0270] Vent

[0271] In one form, the patient interface 3000 includes a vent 3400 that is configured and arranged to allow flushing of exhaled gas (e.g., carbon dioxide).

[0272] In certain forms, the vent 3400 is configured to allow a continuous air flow from the interior of the inflation chamber 3200 to the surrounding environment while the pressure in the inflation chamber is positive relative to the surrounding environment. The vent 3400 is configured such that the air flow rate has a magnitude sufficient to reduce patient re-breathing of exhaled CO2 while maintaining the therapeutic pressure in the inflation chamber during use.

[0273] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0274] The vent 3400 can be located in the inflation chamber 3200. Alternatively, the vent 3400 is located in a disconnect structure, such as a swivel shaft.

[0275] 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).

[0276] The vent 3450 can be used with the mouth and nose inflation chamber 3200-1 (e.g., Figure 4A as illustrated) or only the nose inflation chamber 3200-2 (e.g., Figure 4B as illustrated).

[0277] Continuing to refer Figure 4A , the vent 3450 can include a vent housing 3404, which can be configured to engage with the vent opening 3402. The vent housing 3404 can be constructed of a rigid material or a 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).

[0278] 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 volume of the inflation 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 inflation chamber 3200. The groove 3416 can be formed between the front surface 3408 and the rear surface 3412. A portion of the inflation chamber 3200 can be received within the groove 3416 to hold the vent 3400 in place.

[0279] 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 in the patient interface.

[0280] In some forms, the diffuser 3448 can diffuse and thus slow down the exhaust gas exiting the plenum chamber 3200 and passing through the venting housing 3404. The diffuser 3448 can help avoid jets and associated discomfort to the patient and / or bed partner (e.g., noise caused by jets onto pillows, sheets, bedding, etc.).

[0281] 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 less than the inner diameter of the venting housing 3404 near the front surface 3408. This can form a void 3464 through which air can travel.

[0282] Disconnect structure

[0283] In one form, the patient interface 3000 includes at least one disconnect structure, such as a swivel axis or ball and socket.

[0284] Modular

[0285] 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 therapy and / or the comfort of the individual patient. Examples of such modular designs are described in PCT / SG2022 / 050777, filed Oct. 28, 2022, the entire contents of which are incorporated herein by reference.

[0286] In some forms, different styles 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 because fewer parts can be used to create a greater variety of patient interfaces. Additionally or alternatively, the various combinations can allow the patient to change the style of the patient interface without changing each individual part.

[0287] 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, e.g., Figure 4C 、 Figure 4J ). This can be referred to as an “upper tube” configuration and can locate the connection port at the top of the patient's head. In other examples, the patient can receive a pressurized air stream through a conduit connected to the plenum 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 receiving air in one style of delivery than in others (e.g., due to the patient's sleeping style). Thus, it is beneficial to allow a single style of patient interface to be used in either an “upper tube” or “lower tube” configuration.

[0288] 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 components of different styles. The various combinations that can result from assembling different components are described below.

[0289] Sleeve

[0290] In some forms, to allow for modularity, the sleeve can be used with the tube 3350 and / or the stiffener arm 3340. The sleeve can at least partially surround the tube 3350 and / or the stiffener 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 configuration of the sleeve can be customized to fit a particular user's face. For example, the sleeve can be configured in a relatively more posterior region of the patient's head.

[0291] In some forms, the sleeve can be constructed of a comfortable material. For example, the sleeve can be constructed of a textile material, a foam material, or a combination of both. The comfortable material can contact the patient during use and can feel soft when resting against the patient's skin to improve patient compliance.

[0292] The material can also be flexible to assist in putting on or taking off the sleeve from the tube 3350 or the stiffener 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 stiffener arm 3340, which can vary according to the shape of an individual patient's head.

[0293] 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 assist the sleeve in stretching to fit around the tube 3350 or the stiffener arm 3340. The elastic material can then return to its initial position, which rests against the tube 3350 or the stiffener arm 3340 to limit sleeve slippage during use.

[0294] As described in more detail below, some forms of the cannula can be dedicated to the stiffening element (e.g., the tube 3350 and / or the stiffener arm 3340). However, the sleeve can assist in interchangeably connecting the stiffening element with different versions or styles of the gasket (e.g., the mouth and nose gasket 3050-1, the nose-only gasket 3050-2, etc.).

[0295] Catheter sleeve

[0296] As Figure 4G shown, one example of a sleeve is the catheter sleeve 3351, which can be used with the tube 3350 described above.

[0297] As Figure 4GAs shown, the catheter sleeve 3351 can 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 can allow the catheter sleeve 3351 to bend further to correspond to the shape of the tube 3350 (e.g., when worn by a patient).

[0298] In some forms, the catheter sleeve 3351 can include a first opening or upper opening 3352. The upper opening 3352 can be provided at one end of the catheter sleeve 3351. The upper opening 3352 can be an opening of a channel that extends along at least a portion of the catheter sleeve 3351.

[0299] As Figure 4G shown, some forms of the catheter sleeve 3351 can also include a lower extension 3354. The lower extension 3354 can be positioned at the end of the catheter sleeve 3351 opposite the upper opening 3352. The catheter sleeve 3351 can be customized to fit a particular user's face. For example, the lower extension 3354 of the catheter sleeve 3351 can be configured in a relatively more posterior or anterior region of the patient's head.

[0300] Some forms of the lower extension 3354 can include a rigid or semi-rigid member (e.g., within the catheter sleeve 3351). The rigid or semi-rigid member can be made of a plastic material or a similar material. Alternatively, the lower extension 3354 can be strengthened using manufacturing processes (e.g., stitching hardening lines, flat knitting, using a thicker material).

[0301] As Figure 4G shown, some forms of the lower extension 3354 can include a connecting member 3356. In the illustrated example, the connecting member 3356 can be a magnet, although in other instances, the connecting member 3356 can be a different type of connector (e.g., mechanical fastener, adhesive, hook and loop material, etc.). The connecting member 3356 can also be positioned at one end of the lower extension 3354, although the connecting member 3356 can also be positioned anywhere along the lower extension 3354.

[0302] In some forms, the connecting member 3356 (e.g., a magnet) can be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the catheter sleeve 3351 is connected to the tube 3350 (e.g., see Figure 4J ), the magnet 3370-1 connected to the lower band 3304-1 can be removably connected to the connecting member 3356 to provide tension.

[0303] Four-point arm sleeve

[0304] As Figure 4HAs shown, another example of a sleeve is the four-point arm sleeve 3380, which can be used with the applicator arm 3340 described above.

[0305] As Figure 4H shown, the four-point arm sleeve 3380 can include a curved shape similar to the shape of the applicator arm 3340 shown. The flexible material used to construct the four-point arm sleeve 3380 can allow the four-point arm sleeve 3380 to further bend to correspond to the shape of the applicator arm 3340 (e.g., when worn by a patient and / or bent by a patient). Figure 4D

[0306] 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 positioned at one end of the four-point arm sleeve 3380.

[0307] In the illustrated example, 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 than the rest of the four-point arm sleeve 3380 (e.g., due to hardening of a wire or rigid material).

[0308] As Figure 4H shown, some forms of the lower extension 3384 can include a connecting member 3386. In the illustrated example, 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 positioned at one end of the lower extension 3384, although the connecting member 3386 can also be positioned anywhere along the lower extension 3384.

[0309] 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 applicator arm 3340 (e.g., see Figure 4K ), the magnet 3370-1 connected to the lower band 3304-1 can removably connect to the connecting member 3386 to provide tension.

[0310] 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 the four-point arm sleeve 3380 is worn by a patient, the tabs 3394 can be positioned on the patient's head at substantially the same location as the tabs 3320 are positioned when the patient wears the tube 3350.

[0311] Two-point arm sleeve

[0312] Figure 4I As Figure 4IAs shown, another example of a sleeve is the two-point arm sleeve 3380-1, which can be used with the hardening arm 3340 described above.

[0313] 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 are described below.

[0314] As Figure 4I shown, the two-point arm sleeve 3380-1 can include a lower opening 3388-1 located at one 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 illustrated example, the lower opening 3388-1 can lead to the surface of the catheter sleeve 3380-1.

[0315] 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 two-point arm sleeve 3380-1 is worn by a patient, 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.

[0316] Assembled patient interface

[0317] As Figures 4J to 4M illustrated, the various elements described above can be combined into four different patient interfaces. Different patient interfaces can allow patients to use different styles based on their respective comfort levels. The modularity of the different elements (e.g., the ability to use multiple styles of patient interfaces) can simplify manufacturing and / or can allow patients to more easily switch between multiple styles of patient interfaces.

[0318] Tube configuration on nose and mouth mask

[0319] As Figure 4J illustrated, a patient can wear the cushion 3050-1 in the upper tube configuration with the tube 3350 and the four-point headgear 3302-1. This assembly can form the upper tube nose and mouth patient interface 3000-1.

[0320] In some forms, a catheter sleeve can be used with the tube 3350 to enable the patient to experience the "upper tube" air delivery mode of the mouth and nose cushions 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.

[0321] 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.

[0322] As Figure 4J illustrated, the four-point headgear 3302-1 can be connected at four separate locations to provide the tension to maintain the gasket 3050-1 in a sealed position on the patient's head.

[0323] For example, the lower strap 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 strap 3304-1 can contact the patient's cheek (e.g., covering the masseter muscle). The lower strap 3304-1 can also extend below the patient's ear.

[0324] Lower tube configuration for nose and mouth masks

[0325] As Figure 4K illustrated, the patient can wear the gasket 3050-1 in the lower tube configuration with the stiffener arm 3340 and the four-point headgear 3302-1. This assembly can form the lower tube nose and mouth patient interface 3000-2.

[0326] In some forms, the catheter sleeve can be used with the stiffener arm 3340 to enable the patient to experience the "lower tube" air delivery mode of the mouth and nose gaskets 3050-1. As described below, the catheter sleeve provides an additional connection location for connecting the four-point headgear 3302-1. However, other forms of connectors can be used in addition to or instead of the catheter sleeve.

[0327] In the illustrated example, the catheter sleeve can be connected to the stiffener arm 3340 of the positioning and stabilization structure 3300. The stiffener arm 3340 (via the catheter connection structure 3504) can be used to connect the stiffener 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.

[0328] As Figure 4K illustrated, the four-point headgear 3302-1 can be connected at four separate locations to provide the tension to maintain the gasket 3050-1 in a sealed position on the patient's head.

[0329] 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.

[0330] Nasal mask upper tube configuration

[0331] As Figure 4L Illustrated, the patient can wear the cushion 3050-2 in the upper tube configuration having the tube 3350 and the two-point headgear 3302-2. This assembly can form an upper tube, a nasal-only patient interface 3000-3

[0332] 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 illustrated example, the tube 3350 of the positioning and stabilizing structure 3300 can be directly connected to the cushion 3050-2.

[0333] As Figure 4L Illustrated, the two-point headgear 3302-2 can be connected to the tab 3320 on the tube 3350 to provide the tension to maintain the cushion 3050-2 in a sealed position on the patient's head.

[0334] Nasal mask lower tube configuration

[0335] As Figure 4M Illustrated, the patient can wear the cushion 3050-2 in the upper tube configuration having the stiffener arm 3340 and the two-point headgear 3302-2. This assembly can form a lower tube, a nasal-only patient interface 3000-4.

[0336] The catheter sleeve can be used with the stiffener 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 illustrated example, the stiffener arm 3340 of the positioning and stabilizing structure 3300 can be directly connected to the cushion 3050-2.

[0337] As Figure 4M Illustrated, the two-point headgear 3302-2 can be connected to the tab 3320 on the sleeve to provide the tension to maintain the cushion 3050-2 in a sealed position on the patient's head.

[0338] Component modularity

[0339] 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 styles of patient interfaces. This can allow for easier manufacturing and assembly, as a large number of identical components can be produced and used in various styles. The only component that is 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 that can be docked with the patient interface, while Figure 4N shows that the ventilation housing 3404 of the air circuit shown in Figure 4O can be interchangeably replaced according to the style of the patient interface.

[0340] RPT device

[0341] 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 of the respiratory conditions described elsewhere in this document.

[0342] Air filter

[0343] An RPT device according to one form of the present technology can include an air filter 4110 or a plurality of air filters 4110.

[0344] In Figure 3A one form illustrated, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0345] In Figure 3A one form illustrated, the outlet air filter 4114, such as an antimicrobial filter, is located between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.

[0346] Muffler

[0347] An RPT device according to one form of the present technology can include a muffler 4120 or a plurality of mufflers 4120.

[0348] In one form of the present technology (see, for example, Figure 3A ), the inlet muffler 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0349] 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.

[0350] Pressure generator

[0351] In one form of the technology, the pressure generator 4140 for generating a positive air flow or air supply is a controllable blower 4142. For example, the blower 4142 can include a brushless DC motor 4144 having one or more impellers. These impellers can be located in a volute. The blower can be capable of delivering an air supply at a rate of up to about 120 liters per minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or up to about 30 cmH2O in other forms, such as when delivering respiratory pressure therapy. The blower can be as described in any one of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013 / 020167.

[0352] The pressure generator 4140 can be under the control of a therapy device controller 4240.

[0353] 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.

[0354] Transducer

[0355] The transducer can be inside or outside the RPT device. An external transducer can be located on, for example, 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.

[0356] In one form of the technology (see, for example Figure 3A ) 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 representative of characteristics of the air flow, such as the flow rate, pressure, or temperature at that point in the pneumatic path.

[0357] In one form of the technology, one or more transducers 4270 can be located near the patient interface 3000 or 3800.

[0358] 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.

[0359] RPT sensor

[0360] Flow rate sensor

[0361] The flow rate sensor 4274 according to the present technology can be based on a differential pressure transducer, such as the SDP600 series differential pressure transducer from Sensirion of Switzerland.

[0362] In one form, the signal generated by the flow rate sensor 4274 and representing the flow rate is received by the central controller 4230.

[0363] Pressure sensor

[0364] The pressure sensor 4272 according to the present technology is positioned in fluid communication with the pneumatic path. Examples of suitable pressure sensors are transducers from the ASDX series of Honeywell. An alternative suitable pressure sensor is a transducer from the NPA series of General Electric Company.

[0365] In one form, the signal generated by the pressure sensor 4272 and representing the pressure is received by the central controller 4230.

[0366] Motor speed transducer

[0367] In one form of the present technology, the motor speed transducer 4276 is used to determine the rotational speed of the motor 4144 and / or the blower 4142. The 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.

[0368] Anti-backflow valve

[0369] As Figure 3A shown, in one form of the present technology, the 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, flowing towards the motor 4144.

[0370] RPT device electronics

[0371] Power supply

[0372] The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.

[0373] 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.

[0374] Input device

[0375] 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 external housing 4010, or in another form, can communicate wirelessly with a receiver electrically connected to the central controller 4230.

[0376] In one form, the input device 4220 can be constructed or arranged to allow a person to select values and / or menu options.

[0377] Central controller

[0378] In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000. The central controller 4230 is shown in Figure 3B Shown.

[0379] Suitable processors can include x86 Intel processors, processors based on the ARM® Cortex®-M processors from ARM Holdings, such as the STM32 series microcontrollers from STMicroelectronics. In certain alternative forms of the present technology, 32-bit RISC CPUs, such as the STR9 series microcontrollers from STMicroelectronics, or 16-bit RISC CPUs, such as processors from the MSP430 family of microcontrollers manufactured by Texas Instruments, can be equally applicable.

[0380] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0381] In one form, the central controller 4230 is an application-specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0382] The central controller 4230 can be configured to receive input signals from one or more transducers 4270, one or more input devices 4220, and / or the humidifier 5000.

[0383] The central controller 4230 can be configured to provide output signals to one or more of the output device 4290, the pressure generator 4140, the therapy device controller 4240, the data communication interface 4280, and / or the humidifier 5000.

[0384] 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 performed by a remotely located device. For example, the remotely located device can determine control settings of a ventilator or detect a respiratory-related event by analyzing stored data from any of the sensors described herein.

[0385] Clock

[0386] The RPT device 4000 can include a clock 4232 connected to the central controller 4230.

[0387] Therapy device controller

[0388] In one form of the present technology, the therapy device controller 4240 is the therapy control module 4330, which forms part of the algorithm 4300 executed by the central controller 4230.

[0389] In one form of the present technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, the MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0390] Protection circuit

[0391] One or more protection circuits 4250 according to the present technology can include an electronic protection circuit, a temperature and / or pressure safety circuit.

[0392] Memory

[0393] 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.

[0394] 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.

[0395] 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.

[0396] In one form of the present technology, the memory 4260 serves as a non-transitory computer-readable storage medium on which computer program instructions representing one or more methods described herein, such as one or more algorithms 4300, are stored.

[0397] Data communication system

[0398] In one form of the present technology, a data communication interface 4280 is provided that is connected to the central controller 4230 (see, for example, 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.

[0399] 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.

[0400] 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.

[0401] In one form, the local external communication network 4284 utilizes one or more communication standards, such as Bluetooth or the Consumer Infrared Protocol.

[0402] In one form, the remote external device 4286 is one or more computers, such as a cluster of networked computers. In one form, the remote external device 4286 can be a virtual computer rather than a physical computer. In either case, this remote external device 4286 can be accessed by a properly authorized person, such as a clinician.

[0403] The local external device 4288 can be a personal computer, a mobile phone, a tablet, or a remote control device.

[0404] Output device including optional display, siren

[0405] 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.

[0406] Display driver

[0407] 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.

[0408] display

[0409] The display 4294 is configured to visibly 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.

[0410] Now referring Figure 3A to FIG. 3E, in some forms of the present technology, the central controller 4230 can be configured to implement one or more algorithms 4300 that are expressed as computer programs stored in a non-transitory computer-readable storage medium (such as the memory 4260). The algorithms 4300 are generally grouped into groups called modules.

[0411] 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 data representing the input signals and / or 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 expressed as computer programs, 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 programs configure the controller of the external device to execute the portions of the algorithms 4300.

[0412] In such forms, the therapy parameters generated by the external device via the therapy engine module 4320 (if such forms 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 therapy control module 4330.

[0413] preprocessing module

[0414] According to one form of the present technology, the preprocessing module 4310 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 therapy engine module 4320).

[0415] In one form of the present technology, the output values include interface pressure Pm, ventilation flow rate Qv, respiratory flow rate Qr, and leakage flow rate Ql.

[0416] In various forms 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.

[0417] Interface Pressure Estimation

[0418] 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 4192 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). The interface pressure estimation algorithm 4312 then provides an 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.

[0419] Ventilation Flow Rate Estimation

[0420] 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 port 3400 in the patient interface 3000 or 3800. For a specific ventilation port 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).

[0421] Leakage Flow Rate Estimation

[0422] 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 of the difference between the total flow rate Qt and the ventilation flow rate Qv over a sufficiently long time period (e.g., approximately 10 seconds).

[0423] In one form, the leak flow rate estimation algorithm 4316 receives the total flow rate Qt, the ventilation flow rate Qv, and the estimated pressure Pm in the patient interface 3000 or 3800 as inputs, and provides the leak flow rate Ql as an output by calculating the leak conductance and determining the leak flow rate 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 rate equal to the difference between the total flow rate Qt and the ventilation flow rate 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 approximately 10 seconds. The leak flow rate Ql can be estimated as the product of the leak conductance and the pressure function Pm.

[0424] Respiratory flow rate estimation

[0425] In one form of the present technology, the respiratory flow rate estimation algorithm 4318 receives the total flow rate Qt, the ventilation flow rate Qv, and the leak flow rate Ql as inputs, and estimates the respiratory flow rate Qr of the air to the patient by subtracting the ventilation flow rate Qv and the leak flow rate Ql from the total flow rate Qt.

[0426] Therapy engine module

[0427] In one form of the present technology, the therapy engine module 4320 receives one or more of the pressure Pm in the patient interface 3000 or 3800 and the respiratory flow rate Qr of the air to the patient as inputs, and provides one or more therapy parameters as outputs.

[0428] In one form of the present technology, the therapy parameter is the treatment pressure Pt.

[0429] In one form of the present technology, the therapy parameter is one or more of the pressure change amplitude, the baseline pressure, and the target ventilation.

[0430] In various forms, the therapy engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation volume determination 4323, inspiratory flow rate limit determination 4324, apnea / hypopnea determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and therapy parameter determination 4329.

[0431] Phase determination

[0432] In one form of the present technology, the RPT device 4000 does not determine the phase.

[0433] In one form of the present technology, the phase determination algorithm 4321 receives a signal indicating the respiratory flow rate Qr as an input, and provides the phase Φ of the current respiratory cycle of the patient 1000 as an output.

[0434] Waveform determination

[0435] In one form of the present technology, the therapy parameter determination algorithm 4329 provides an approximately constant therapy pressure throughout the patient's respiratory cycle.

[0436] In other forms of the present technology, the therapy control module 4330 controls the pressure generator 4140 to provide a therapy pressure Pt that varies as a function of the phase Φ of the patient's respiratory cycle according to the waveform template Π(Φ).

[0437] 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 therapy parameter determination algorithm 4329.

[0438] Ventilation determination

[0439] 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.

[0440] Determination of inspiratory flow limitation

[0441] In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 for determining the degree of inspiratory flow limitation.

[0442] Determination of apnea and hypopnea

[0443] In one form of the present technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 for determining the presence of apnea and / or hypopnea.

[0444] Snoring determination

[0445] 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.

[0446] Airway patency determination

[0447] 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.

[0448] Determination of target ventilation

[0449] In one form of the present technology, the central controller 4230 takes as an input a measurement of the current ventilation Vent and executes one or more target ventilation determination algorithms 4328 for determining a target value Vtgt of the ventilation measurement.

[0450] Determination of therapy parameters

[0451] In some forms of the present technology, the central controller 4230 executes one or more therapy parameter determination algorithms 4329 for determining one or more therapy parameters using values returned by one or more other algorithms in the therapy engine module 4320.

[0452] Therapy control module

[0453] The therapy control module 4330 according to one aspect of the present technology receives as input the therapy parameters from the therapy parameter determination algorithm 4329 of the therapy engine module 4320 and controls the pressure generator 4140 to deliver an air flow according to the therapy parameters.

[0454] In one form of the present technology, the therapy parameter is the treatment pressure Pt, and the therapy 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.

[0455] Detection of fault conditions

[0456] 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:

[0457] · Power failure (no power or insufficient power)

[0458] · Transducer fault detection

[0459] · Failure to detect the presence of a component

[0460] · Operating parameters outside the recommended range (e.g., pressure, flow rate, temperature, PaO2)

[0461] · Test alarm fails to generate a detectable alarm signal.

[0462] ·

[0463] Upon detection of a fault condition, the corresponding algorithm signals the presence of the fault by one or more of the following:

[0464] · Activating an audible, visual, and / or dynamic (e.g., vibration) alarm

[0465] · Sending a message to an external device

[0466] · Event logging

[0467] Patient interface detection

[0468] Figure 5AIllustrates a schematic diagram of a respiratory therapy system 8000, and Figure 6 illustrates an example of the techniques described herein in the context of an upper tube patient interface. Figure 5B Illustrates another schematic diagram of a respiratory therapy system 8000. The respiratory therapy system 8000 can be configured to wirelessly detect the identity of a patient interface 3000 or an accessory that a patient is using during a therapy session. Specifically, the respiratory therapy system 8000 can be configured to be used with an upper tube patient interface, such as Figure 4J the patient interface 3000-1 of Figure 4L or the patient interface 3000-3 of Figure 4K such as a full face, nasal, or pillow cushion upper tube patient interface. The upper tube patient interface 3000 can include one or more radio frequency identification (RFID) tags incorporated within the patient interface 3000. For example, the RFID tag can be incorporated with one or more of a pillow cushion of the patient interface 3000 or other sealing forming structure 3100, a conduit of the patient interface 3000 (such as tube 3350), or near a connection point to an air circuit. Aspects of the techniques described herein can involve including an extended antenna portion within an upper tube patient interface having a stretchable portion (e.g., a corrugated accordion portion such as the extendable accordion structure 3362 described above) to facilitate accurate reading of one or more RFID tags even when positioned further away from a reader antenna and transceiver. Although the techniques disclosed in this section are discussed in the context of an upper tube configuration, the techniques can also be used in a lower tube configuration (such as Figure 4M the patient interface 3000-2 of

[0469] The respiratory therapy system 8000 includes a patient interface 3000 and a respiratory pressure therapy (RPT) device 4000, which is configured to be fluidly coupled via an air circuit 4170, which can be a conduit or tube as discussed above. The respiratory therapy system 8000 further includes a conduit headgear 4180, which is configured to be fluidly connected to the air circuit 4170 and direct a gas flow from the RPT device 4000 through the air circuit 4170, through the conduit headgear 4180, and to the patient interface 3000. The RPT device 4000 is configured to supply a gas flow to the patient interface 3000 via the air circuit 4170 and the conduit headgear 4180, such as air that can supplement oxygen. Although not shown, the respiratory therapy system 8000 can also include a humidifier, an oxygen source, and / or a data management system as discussed above with respect to the RPT device 4000.

[0470] The RPT device 4000 can be used alone or as part of a system 8000 to deliver one or more of the above-described multiple therapies, such as by operating the device to generate an air flow for delivery to an interface (e.g., patient interface 3000) to the 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 a ventilator.

[0471] As described above, the respiratory therapy system 8000 can also include a radio frequency identification (RFID) system 9000. 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 objects. The RFID system 9000 can operate according to the principle of inductive coupling.

[0472] An example RFID system (such as the RFID system 9000) can include at least one RFID reader and at least one RFID tag. The RFID reader can include an antenna (sometimes referred to herein as a "reader antenna") and an RFID reader and / or writer (sometimes referred to herein as a "reader chip"), which is an integrated circuit. Illustrative examples of RFID readers can include, for example, the MFRC522 from NXP. In an example, the RFID reader can be coupled to, for example, a microcontroller (e.g., a hardware processor) that is used to read and / or process data transmitted to / from the RFID reader. The RFID tag can include an antenna (sometimes referred to herein as a "tag antenna") and another integrated circuit (sometimes referred to herein as a "tag chip"), which can include a non-transitory memory for storing data therein.

[0473] The RFID system 9000 can 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, the identification of the air circuit 4170, the identification of the catheter headgear 4180, and / or the identification of an accessory device (not shown) directly or indirectly coupled to the respiratory therapy system 8000. Exemplary accessory devices can include, but are not limited to, a mask headgear, a gasket or other seal-forming structure 3100 on the patient interface 3000, an air filter, a humidifier, one or more components of a humidification system (e.g., a heat and moisture exchanger or a waterless humidifier), an additional catheter, and / or a software protector (dongle) accessory.

[0474] In one aspect, an RFID reader (e.g., first antenna 9100A and transceiver 9300) can be associated with air circuit 4170, and the RFID reader can be a reader chip, as further described below. Any antenna disclosed herein (including first antenna 9100A) can include a flexible printed circuit, coil wires, and / or conductive printing on a substrate such as plastic. Additionally or alternatively, first transceiver 9300 can be associated with (e.g., disposed in or on) RPT device 4000. When air circuit 4170 is coupled to conduit headgear 4180 in an above-tube configuration, an RFID tag 9200 associated with, for example, patient interface 3000 or a gasket or other seal-forming structure 3100 can be spaced apart from first antenna 9100A and transceiver 9300. As a result, an RFID tag 9200 associated with, for example, patient interface 3000 or a gasket or other seal-forming structure 3100 may be outside the read range of first antenna 9100A and transceiver 9300. Although the read range can be increased by increasing the size of the antenna associated with RFID tag 9200, the size of conduit headgear 4180, patient interface 3000, one or more gaskets or other seal-forming structures 3100, or other accessories can be relatively small. Thus, it may not be possible to accommodate a larger antenna as part of conduit headgear 4180, patient interface 3000, one or more gaskets or other seal-forming structures 3100, or other accessories to increase the read range.

[0475] As an example, when air circuit 4170 is coupled to conduit headgear 4180, a gasket for a typical above-tube patient interface (e.g., full-face, nasal, or pillow above-tube configuration) can be approximately 250 mm to approximately 300 mm from the proximal end of air circuit 4170. Thus, it may be difficult for first antenna 9100A associated with air circuit 4170 to detect an RFID tag associated with the gasket. Additionally, for a smaller diameter air circuit 4170, there may not be room on or within air circuit 4170 to accommodate a first antenna 9100A that is large enough.

[0476] In view of the foregoing, aspects of the techniques described herein are drawn to an extended antenna configuration to create a medium to transfer the required energy from an RFID reader (e.g., antenna 9100A and transceiver 9300) to an RFID tag 9200 at a distance, such as a distance greater than the magnetic field emitted by antenna 9100A, in which RFID system 9000 is configured to operate. Additionally, aspects of the extended antenna techniques described herein can be used in compatibility with a stretchable or flexible conduit headgear 4180, which can include, for example, a stretchable corrugated bellows-like portion along two tubes of the conduit headgear.

[0477] Aspects of the technology described herein are also depicted as wirelessly providing power from, for example, an antenna to electronic components (such as, 9200A, 9200B, 9100B, 9100C, etc.) included in a flexible conduit headgear (such as, 4180) and / or a patient interface (such as, 3000). In one aspect, the energy provided in this manner may allow for wireless power to be received at one end of the flexible conduit headgear and then provided to other electronic components of the flexible conduit headgear via wires included with the flexible conduit headgear. In an example, another antenna (such as, 9100C) in the flexible conduit headgear may be used to wirelessly provide power to another electronic component, such as a tag included in the patient interface. Thus, power may be supplied to the electronic components of the flexible conduit headgear (and in some instances the patient interface) without having to rely on or use, for example, a physical electrical connection between the flexible conduit headgear and another component such as the air circuit 4170. Additionally, when power is supplied wirelessly to the flexible conduit headgear, there is no need to include a power source (such as, a battery) within the flexible conduit headgear.

[0478] The RFID system 9000 includes a first antenna 9100A, a second antenna 9100B, a third antenna 9100C, a first transponder 9200A (hereinafter referred to as "the first tag"), a second transponder 9200B (hereinafter referred to as "the second tag"), and a transceiver 9300. Each of the first antenna 9100A, the second antenna 9100B, and the third antenna 9100C is configured to transmit radio waves and receive reflected signals, for example, from the first tag 9200A and / or the second tag 9200B. Each of the first antenna 9100A, the second antenna 9100B, and the third antenna 9100C may be a linear antenna and may thus transmit a linearly polarized signal, or each of the first antenna 9100A, the second antenna 9100B, and the third antenna 9100C may be a circular antenna and may thus transmit a circularly polarized signal. Combinations of linear antennas and circular antennas are also contemplated.

[0479] The first antenna 9100A can be disposed at a proximal portion of the air circuit 4170 at a region where the air circuit 4170 is configured to be coupled to the catheter headgear 4180. For example, the first antenna 9100A can be disposed at a portion of the air circuit 4170, such as, for example, within the lumen of the air circuit 4170, within a cover on the proximal portion of the air circuit 4170, within the wall of the air circuit 4170, or on an outer surface of the air circuit 4170. In some aspects, the first antenna 9100A can be incorporated as part of an adapter (not shown) configured to couple the air circuit 4170 to the catheter headgear 4180. The first antenna 9100A and the transceiver 9300 can also be configured to transfer data received from the first tag 9200A and / or the second antenna 9100B to, for example, another component within the system 8000, such as the RPT device 4000 or a controller (such as the central controller 4230), or to a component external to the system 8000 (such as the remote external device 4286 or the local external device 4288).

[0480] In an example, the transfer of such data can be performed using a suitable transceiver, as described above, which can be the same as the transceiver 9300 or can be separate / different from the transceiver 9300 (e.g., different from the transceiver of an RFID reader). For example, as Figure 5B shown, the transceiver 9300' can transfer data to / from the RFID reader 9100A'. In other words, in an example, the air circuit 4170 can include a first transceiver (which can be part of an RFID reader) and a second separate transceiver (9300'), the first transceiver for performing RFID communication with an RFID tag included in the catheter headgear 4180 (via the antenna 9100A), and the second separate transceiver for transferring data to / from, for example, the RPT device 4000 or another device (such as a smart phone or other remote computing device).

[0481] The second antenna 9100B can be associated with the catheter headgear 4180. For example, the second antenna 9100B can be located in the distal portion of the catheter headgear 4180 (e.g., near where the proximal portion of the air circuit 4170 is configured to couple to the catheter headgear 4180). For example, the second antenna 9100B can be disposed on or within a portion of the catheter headgear 4180 (e.g., within a cover on the distal portion of the catheter headgear 4180, on the outer surface of the catheter headgear 4180, or within the wall of the catheter headgear 4180). The second antenna 9100B is configured to transmit data to the first antenna 9100A and the transceiver 9300. The second antenna 9100B is physically and / or electrically coupled to the third antenna 9100C via, for example, one or more electrical connections 9105. The electrical connection 9105 can include any type of conduit for transmitting electrical signals, such as one or more of a wire, a flexible printed circuit (FPC), a conductive textile, a conductive printed plastic, or a conductive silicone. Thus, data can be transmitted from the third antenna 9100C, which is spaced apart from the second antenna 9100B, to the second antenna 9100B via the electrical connection 9105. The electrical connection 9105 can be disposed on or within the wall of the catheter headgear 4180. For example, the electrical connection 9105 can be disposed within the material comprising the catheter headgear 4180 or external to the catheter headgear 4180. In some configurations, the electrical connection 9105 can be at least partially coated or encapsulated, for example, to prevent breakdown due to exposure to fluid, humidity, or temperature.

[0482] In some aspects, the electrical connection 9105 can not be located in the air passage of the catheter headgear 4180. Positioning the electrical connection 9105 within the catheter headgear 4180 in a gas flow may disrupt the gas flow, which can interfere with treatment. Alternatively or additionally, positioning the electrical connection 9105 within the catheter headgear 4180 can expose the electrical connection 9105 to moisture in the humidified air flowing therethrough, which can affect the integrity of the electrical connection 9105, for example, causing corrosion of these wires. If the electrical connections 9105 are located in the air passage, they can be encapsulated, coated, covered, or otherwise protected from exposure to moisture.

[0483] The third antenna 9100C can be disposed at the proximal portion of the catheter headgear 4180 (e.g., near the patient interface 3000). For example, the third antenna 9100C can be on or within a portion of the catheter headgear 4180 (e.g., within a cover on the distal portion of the catheter headgear 4180, or on the outer surface of the catheter headgear 4180). The third antenna 9100C is configured to transmit a signal to the second antenna 9100B via, for example, the electrical connection 9105. The third antenna 9100C is also configured to receive a signal from the second tag 9200B, which can be transmitted to the second antenna 9100B. The second antenna 9100B can then be read by the first antenna 9100A.

[0484] As described above, the RFID system 9000 can include at least one or more tags 9200. In Figure 5A , Figure 5B and Figure 6 the example shown, the RFID system 9000 can include a first tag 9200A and a second tag 9200B, which can each be configured to transmit radio waves to convey information. The first tag 9200A and the second tag 9200B can each include a microchip configured to store and process information. For example, the first tag 9200A can store data related to the unique identifier of the first tag 9200A and the second antenna 9100B, enabling the first tag 9200A to receive radio signals and / or transmit radio signals to the second antenna 9100B. Similarly, the second tag 9200B can store data related to the unique identifier of the second tag 9200B and the third antenna 9100C, enabling the second tag 9200B to receive radio signals and / or transmit radio signals to the third antenna 9100C. The first tag 9200A and the second tag 9200B can be passive tags. If passive tags are used, the passive tags can rely on the power of the antenna to transmit data and can therefore have a shorter transmission range. For example, the first tag 9200A can receive all the required energy from the magnetic field in which the first tag 9200A operates. Similarly, the second tag 9200B can receive all the required energy from the magnetic field in which the second tag 9200B operates.

[0485] In an example, a battery (not shown) can be included in the catheter headgear 4180 to supply power to any one or all of the antenna 9100B, the tag 9200A, and the antenna 9100C. The battery can be included in the first tag 9200A, the second tag 9200B (e.g., such that they are active tags), or provided separately. In an example, the battery life of the first tag 9200A, the second tag 9200B, and / or the included battery can have a life designed to match or exceed the service life of the associated components (e.g., patient interface, catheter headgear, etc.).

[0486] The first tag 9200A and the second tag 9200B can each be read-only, read / write, write-once, multi-read, or any combination thereof. The first tag 9200A and the second tag 9200B can each be configured to include the catheter headgear 4180, the patient interface 3000, and / or the identification data of the patient. In some aspects, at least one of the first tag 9200A and the second tag 9200B can include information related to the use date or timestamp. The first tag 9200A and the second tag 9200B can each additionally or alternatively include information related to the type of catheter headgear 4180 used, the type of patient interface 3000 used, the characteristics of the catheter headgear 4180 or the patient interface 3000 (e.g., padding material, padding size, catheter size, patient interface size, the length of use of the patient interface or catheter headgear, the manufacturing date of the patient interface or catheter headgear, one or more of a set of respiratory therapy conditions suitable for use with the patient interface or catheter headgear, etc.), the serial identification number of the patient interface 3000 or catheter headgear 4180, and / or other aspects of the respiratory therapy system 8000. In some aspects, the first tag 9200A and / or the second tag 9200B can be configured to include patient information, such as the type of therapy or therapy settings the patient desires to receive, or other information.

[0487] In one example, referring to Figure 6 , the first tag 9200A can be associated with the catheter headgear 4180 and can be configured to store the identification data of the catheter headgear 4180. The second tag 9200B can be associated with the patient interface 3000' or the padding of the patient interface 3000', and can be configured to store the identification data of the patient interface 3000' or the padding of the patient interface 3000'. When the air circuit 4170 is connected to the catheter headgear 4180, the first antenna 9100A can detect the first tag 9200A and receive the identification data of the catheter headgear 4180. The third antenna 9100C can detect the second tag 9200B and receive the identification data of the patient interface 3000' or the padding of the patient interface 3000', which can then be transmitted along the electrical connection 9105 to the second antenna 9100B. The first antenna 9100A can then read the data from the second antenna 9100B.

[0488] As discussed above, although two tags 9200 are depicted in the drawings, in certain aspects, only one tag 9200 can be incorporated in the RFID system 9000. In other aspects, more than two tags, such as three, four, five, or more tags, can be incorporated in the RFID system 9000. If multiple tags are incorporated in the RFID system 9000, an anti-collision mechanism can be enabled to allow the reader to accurately read one or more tags simultaneously.

[0489] In some embodiments, the first tag 9200A may include an adhesive, for example, to assist in applying the first tag 9200A to the catheter headgear 4180 and / or to maintain the first tag 9200A in place on the catheter headgear 4180 after application. Alternatively, the first tag 9200A may be overmolded within a portion of the catheter headgear 4180 or integrally formed on a portion of the catheter headgear 4180. Alternatively, the first tag 9200A may include conductive silicone and / or conductive wires directly on a portion of the catheter headgear 4180. In some aspects, the first tag 9200A may be incorporated as part of a sleeve that is assembled onto the catheter headgear 4180. The first tag 9200A may be coupled to the catheter headgear 4180 by any suitable method commonly used in the art.

[0490] Similarly, the second tag 9200B may include an adhesive, for example, to assist in applying the second tag 9200B to the patient interface 3000 or its gasket and / or to maintain the second tag 9200B in place on the patient interface 3000 after application. Alternatively, the second tag 9200B may be overmolded within a portion of the patient interface 3000 or integrally formed on a portion of the patient interface 3000. Alternatively, the second tag 9200B may include conductive silicone and / or conductive wires directly on a portion of the patient interface 3000. Additionally or alternatively, an ink (e.g., silver ink) may be printed onto a substrate such as fabric to form the second tag 9200B, or the tag 9200B may include an overmolded inlay marker or other conductive textile. The second tag 9200B may be coupled to the patient interface by any suitable method used in the art.

[0491] The first tag 9200A and the second tag 9200B may each be an RFID tag, and in some cases, may each be a near field communication (NFC) tag. Alternatively, the tags 9200A and 9200B may be ultra-high frequency (“UHF”), Bluetooth, or ultra-wideband (UWB) tags. The first tag 9200A and the second tag 9200B may each be configured to generate an electromagnetic field having a frequency of about 13.56 megahertz (MHz). For example, the first antenna 9100A may be configured to read data transmitted from the first tag 9200A at 13.56 MHz. Similarly, the third antenna 9100C may be configured to read data transmitted from the second tag 9200B at about 13.56 MHz. The first antenna 9100A may also be configured to read data transmitted from the second antenna 9100B at about 13.56 MHz.

[0492] In other aspects, the RFID system 9000 can alternatively be configured to generate an electromagnetic field having a frequency between about 30 kilohertz (kHz) and about 12 gigahertz (GHz) (e.g., from about 10 MHz to about 12 GHz). In some instances, the RFID system 9000 can be configured to operate in a low frequency range, or between about 30 kHz and 300 kHz. Thus, the RFID system 9000 can be configured to have a read range of up to about 10 centimeters (about 3.94 inches), although the exact distance can vary depending on, for example, the angles of the various 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 about 3 MHz and 30 MHz. In this configuration, the RFID system 9000 can be configured to have a read range between about 10 centimeters and about one meter (about 3.94 inches to about 39.37 inches). Additionally, the RFID system 9000 can be configured to operate in an ultra-high frequency range, or between about 300 MHz and 3 GHz. In this configuration, the RFID system 9000 can be configured to have a read range between about one meter and about 12 meters.

[0493] 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 the low frequency range, the likelihood of the RFID system 9000 inadvertently reading peripheral devices is reduced. Even when the RFID tag is spaced apart from the antenna and transceiver, the extended antenna configurations described herein can facilitate the use of the shorter read range of the RFID system 9000.

[0494] The first antenna 9100A, the second antenna 9100B, and the third antenna 9100C can be set to the same inductance for first tags 9200A and second tags 9200B of different types (e.g., patient interface 3000, catheter headgear 4180, or other accessory devices) such that the antennas 9100 can be compatible with various patient interface components.

[0495] The RFID system 9000 can include a first tag 9200A fixedly or removably coupled to the catheter headgear 4180 and / or a second tag 9200B fixedly or removably coupled to the patient interface 3000 or an accessory device (not shown). Alternatively, the RFID system 9000 can include two or more first tags 9200A fixedly or removably coupled to the catheter headgear 4180 and / or two or more second tags 9200B fixedly coupled to the patient interface 3000 or an accessory device (not shown). The first tag 9200A and / or the second tag 9200B described herein can be off-the-shelf components or can be customized according to the size and / or shape of the patient interface 3000 or the catheter headgear 4180 and / or according to the desired read range of the first tag 9200A and the second tag 9200B.

[0496] The first antenna 9100A can be configured to receive data from the second antenna 9100B and the first tag 9200A (as noted herein, 9100B and 9200A can be embodied within the same RFID tag). The first antenna 9100A is also configured to transfer the data received from the second antenna 9100B and the first tag 9200A to a transceiver or reader 9300. The transceiver 9300 can be operatively connected to the first antenna 9100A physically (via a wire), for example, and can be located on the air circuit 4170. In one configuration, the transceiver 9300 can be external to the respiratory therapy system 8000. For example, the transceiver 9300 can be a scanner, a smart phone, a tablet computer, or any other device configured to receive RFID signals transmitted from RFID tags or antennas. Thus, the first antenna 9100A is configured to transfer the data received from one or more tags 9200 to the transceiver 9300. The transceiver 9300 can also be configured to save or store the data transferred from the first antenna 9100A.

[0497] The transceiver 9300 can relay information from the first antenna 9100A to a controller (e.g., the central controller 4230 and / or the therapy control module 4330) configured to control the RPT device 4000. The controller can be separate from the RPT device 4000 or can be incorporated as part of the RPT device 4000. The controller can operate as described above. In some configurations, the transceiver 9300 can be configured to physically (e.g., via a wire) or wirelessly transmit data to the RPT device 4000. The RPT device 4000 can also be configured to save or store the data transmitted from the transceiver 9300, interpret the transmitted data, and / or transmit an alert or signal to the user or caregiver, as described above. In some embodiments, the RPT device 4000 can also be configured to automatically change one or more characteristics of the respiratory pressure therapy, e.g., based on the raw data and / or the interpreted data received from the transceiver 9300. Additionally or alternatively, the RPT device 4000 can be configured to suggest one or more therapy settings, e.g., to facilitate patient care and / or patient comfort based on the interpreted data from the transceiver 9300, which will be discussed further below.

[0498] Although not shown in Figure 6 the transceiver 9300 can be combined with the first antenna 9100A. For example, the transceiver 9300 and the first antenna 9100A can form a single combined component. The combined component can have any or all of the characteristics of the first antenna 9100A and the transceiver 9300 described above. For example, the combined first antenna 9100A and transceiver 9300 can be configured to send data or receive data from a controller of the RPT device 4000, such as the central controller 4230.

[0499] Figure 6 A perspective view of an exemplary patient interface 3000' and a catheter headgear 4180 is illustrated. The patient interface 3000' can be used with the system 8000 described above. The catheter headgear 4180 is a catheter or tube constructed and arranged to allow airflow to travel between two components of a respiratory therapy system, such as an air circuit 4170 and the patient interface 3000', in use.

[0500] The proximal portion 4170A of the air circuit 4170 can be coupled to a second portion 4180B of the catheter headgear 4180. The air circuit 4170 can be coupled to the catheter headgear 4180 via, for example, a fitting 4190. The fitting 4190 can allow the air circuit 4170 to rotate and move while still maintaining the connection between the air circuit 4170 and the catheter headgear 4180. In alternative embodiments, the air circuit 4170 is directly coupled to the catheter headgear 4180.

[0501] The catheter headgear 4180 can bifurcate or branch into a first portion 4180A and a second portion 4180B. The distal portion of the first portion 4180A of the catheter headgear 4180 can include a flexible or stretchable portion, such as a first bellows portion 4200A, and the second portion 4180B of the catheter headgear 4180 can include a flexible or stretchable portion, such as a second bellows portion 4200B. For the purposes of this specification, the first bellows portion 4200A and the second bellows portion 4200B can be substantially the same. For example, the first bellows portion 4200A can extend a first length along the first portion 4180A of the catheter headgear 4180, and the second bellows portion 4200B can extend the same length along the second portion 4180B of the catheter headgear 4180. Each of the first bellows portion 4200A and the second bellows portion 4200B can be corrugated. Thus, the first bellows portion 4200A and / or the second bellows portion 4200B can, for example, extend and / or compress to adjust the catheter headgear 4180 to the patient's face. The first bellows portion 4200A and / or the second bellows portion 4200B can extend along the entire length of the catheter headgear 4180, or can extend along less than the entire length of the catheter headgear 4180, such as along most of the length of the catheter headgear 4180, or along less than most of the length of the catheter headgear 4180. In the illustrated example, each of the first portion 4180A and the second portion 4180B includes a bellows portion, namely the first bellows portion 4200A and the second bellows portion 4200B. In an alternative example, neither the first portion 4180A nor the second portion 4180B can include bellows portions on both sides.

[0502] Due to the flexibility and stretchability of the catheter headgear 4180, it can be challenging to incorporate wires extending along the catheter headgear 4180. In particular, due to the first bellows portion 4200A and / or the second bellows portion 4200B, the electrical connection 9105 can be difficult to incorporate on or within the catheter headgear 4180. The electrical connection 9105 may need to maintain the correct antenna impedance while being stretchable. One or more of these challenges can be addressed by aspects of the techniques described herein.

[0503] In addition, it should be understood that aspects of the present technology can be applied to a single branch conduit, e.g., a single conduit arranged in an upper tube configuration where the conduit extends to a location at the top of the patient's head (e.g., Adam circuit), and / or a single conduit arranged in a lower tube configuration where the conduit hangs down from the front of the patient's face. For example, a single conduit can include a portion configured to extend from a distal end to a proximal end (e.g., a distal end configured to couple to an air circuit and a proximal end configured to couple to a patient interface), a stretchable bellows portion configured to extend along the length of the portion, and an electrical connection (e.g., a stretchable conductor) configured to extend along at least a portion of the stretchable bellows portion. A single conduit is sometimes referred to as a "short tube" and extends from a patient interface to a main air delivery tube from a flow generator. When a load (e.g., gravity and / or tube resistance) is applied, such a single conduit short tube is capable of unfolding or stretching from an intermediate position to a stretched position in a longitudinal direction, e.g., 5% to 100% stretch, and at least partially returning to the intermediate position due to elastic resilience when the load is reduced or removed. A single conduit is also capable of being compressed in the longitudinal direction.

[0504] As previously discussed, the first antenna 9100A can be disposed on or within the proximal portion 4170A of the air circuit 4170. The second antenna 9100B can be disposed on or within the distal portion of the conduit headgear 4180 that is configured to couple to the air circuit 4170. The first tag 9200A can be adjacent to or near the first antenna 9100A, e.g., within the second portion 4180B of the conduit headgear 4180. In an example, the second antenna 9100B is provided as part of the first tag 9200A (e.g., as the antenna portion of an RFID tag). In an example, the second antenna 9100B is provided separately from the first tag 9200A (e.g., the antenna portion of the RFID tag can be separate from the second antenna 9100B). The distal end of the electrical connection 9105 is coupled to the second antenna 9100B. The electrical connection 9105 can extend from the second antenna 9100B on or within the distal portion of the first portion 4180A of the conduit headgear 4180 to the proximal portion of the first portion 4180A. The electrical connection 9105 can extend outside of the conduit headgear 4180 or can extend within the material including the conduit headgear 4180 or within a coating applied to the conduit headgear 4180. In one example, the electrical connection 9105 can be integrated within the material including the conduit headgear 4180. As previously discussed, in some aspects, the electrical connection 9105 can not be positioned within the air flow channel of the conduit headgear 4180.

[0505] The proximal end of the electrical connection 9105 is coupled to the third antenna 9100C. The third antenna 9100C is disposed on or within the proximal portion of the air circuit 4170, for example, within the proximal portion of the first part 4180A of the catheter headgear 4180. The proximal end of the first part 4180A of the catheter headgear 4180 may be directly or indirectly coupled to the patient interface 3000'. The second tag 9200B may be associated with the patient interface 3000', the gasket, or one or more other accessories. Although the electrical connection 9105 and the third antenna 9100C are depicted with reference to the first part 4180A, the second part 4180B may also incorporate a similar structure, and the catheter headgear may be substantially symmetric. However, in some aspects, one of the first part 4180A or the second part 4180B may incorporate the third antenna 9100C and the electrical connection 9105, while the other of the first part 4180A or the second part 4180B may not. As described above, the first part 4180A and / or the second part 4180B may include bellows sections, and the third antenna 9100C and the electrical connection 9105 may be provided to the first part and / or the second part.

[0506] In one aspect, to accommodate the flexible stretchability of the first bellows section 4200A and the second bellows section 4200B, the electrical connection 9105 may extend along a serpentine path. As Figure 6 shown, the electrical connection 9105 forms a plurality of curves 9106. The plurality of curves 9106 may extend along a portion of the electrical connection 9105 or along the entirety of the electrical connection 9105. For example, the plurality of curves 9106 may extend along at least the first bellows section 4200A.

[0507] Each of the plurality of curves 9106 may be the same or similar in size. Alternatively, one or more of the plurality of curves 9106 may be different in size. For example, one or more of the plurality of curves 9106 may be larger or smaller to accommodate variations in the curvature of the catheter headgear 4180 or the corrugations of the bellows section. By arranging the electrical connection 9105 to have a plurality of curves 9106, or by arranging it, for example, in a zigzag or serpentine path, stretching or bending of the catheter headgear 4180 can result in a relatively small increase in tension on the electrical connection 9105. This configuration can also reduce the chance of the electrical connection 9105 failing due to repeated stretching and / or bending cycles.

[0508] In another aspect, the electrical connection 9105 itself may have a coiled or serpentine configuration to allow stretchability. The electrical connection 9105 having a coiled or serpentine configuration may extend along a more direct path from the second antenna 9100B to the third antenna 9100C, or may follow a serpentine or zigzag path. The electrical connection 9105 itself may or may not be formed of a stretchable material.

[0509] In some aspects, the electrical connection 9105 can be formed of a stretchable conductive material and can be incorporated onto or within the sleeve 9107, as shown by the stippled portion in Figure 6 . The sleeve 9107 can cover the catheter headgear 4180 and can be removable relative to the catheter headgear 4180, or the sleeve 9107 can be fixedly coupled to the outer surface of the catheter headgear 4180 (e.g., coupled to the first portion 4180A of the catheter headgear 4180 (as shown), coupled to the second portion 4180B, or coupled to both the first portion 4180A and the second portion 4180B). The sleeve 9107 can surround (e.g., wrap around) a portion of the catheter headgear 4180 or around the entire circumference of the catheter headgear 4180. Additionally or alternatively, the sleeve 9107 can extend along the entire length or less than the entire length of the first portion 4180A and / or the second portion 4180B of the catheter headgear 4180. In some aspects, the sleeve 9107 can cover most or substantially all of the outer surface of the catheter headgear 4180, including, for example, around the opening in the catheter headgear 4180 configured to be coupled to the air circuit 4170.

[0510] The sleeve 9107 can include one or more materials. For example, the sleeve 9107 can include one or more of flexible conductive silicone, conductive fibers or wires, stretchable conductive textiles, or other suitable materials or combinations of materials. The material can include conductive traces, such as copper traces, or conductive fibers or wires, which can be printed, thermally bonded, stitched, or otherwise incorporated onto or into the material. In some aspects, a metal gel soft circuit can be used to form the electrical connection 9105. The metal gel soft circuit can include a membrane in the form of a textile that can be incorporated into the sleeve 9107. Additionally, the metal gel soft circuit can include one or more stabilizing additives to allow the material to withstand high-pressure lamination and thermal welding processes without displacement. The metal gel soft circuit can be configured to withstand bending, stretching, or twisting.

[0511] The sleeve 9107 can include a flexible material and / or a stretchable material and can include corrugated portions or be configured to stretch or otherwise accommodate corrugated portions, such as the first bellows portion 4200A and / or the second bellows portion 4200B of the catheter headgear 4180. For example, the sleeve 9107 can be configured to be extended or stretched and compressed to accommodate the length of the first portion 4180A or the second portion 4180B of the catheter headgear 4180 as it changes.

[0512] Additionally or alternatively, the sleeve 9107 may also include a second antenna 9100B and a third antenna 9100C. For example, the second antenna 9100B may be disposed on or within the first end of the sleeve 9107 (e.g., near or adjacent to the attachment location of the air circuit 4170), and / or the third antenna 9100C may be disposed on or within the second end of the sleeve 9107 (e.g., near or adjacent to the patient interface 3000'). If the sleeve 9107 is configured to cover both the first portion 4180A and the second portion 4180B of the catheter headgear 4180, one or more additional antennas may be disposed on or within the sleeve 9107, e.g., if substantially symmetric antenna extensions are provided along both the first portion 4180A and the second portion 4180B of the catheter headgear 4180).

[0513] Figure 7 A top perspective view of an exemplary portion of the catheter headgear 4180 is illustrated. In this configuration, the second antenna 9100B surrounds or encircles the opening 4182, where the air circuit 4170 is configured to be coupled to the catheter headgear 4180. The second antenna 9100B may be, for example, incorporated into the material of the catheter headgear 4180 manufactured around the opening 4182, may be printed, thermally bonded, adhered, or coated around the opening 4182, or may be incorporated into a sleeve, such as a textile sleeve, that fits over the catheter headgear 4182 and surrounds the opening 4182. The opening 4182 is configured to be (e.g., directly or indirectly) coupled to the air circuit 4170. Although not shown, in some configurations, the first antenna 9100A surrounds or encircles a corresponding opening on the air circuit 4170.

[0514] To accommodate the corrugations of the first bellows portion 4200A, the electrical connection 9105 may include a distal portion 9105A having a plurality of curves 9106. The plurality of curves 9106 may extend along the entire length of the first bellows portion 4200A or along a portion of the first bellows portion 4200A. Thus, the plurality of curves 9106 may include one curve, two curves, three curves, etc. For example, when the first bellows portion 4200A expands and / or contracts, the plurality of curves 9106 may cause the electrical connection 9105 to extend and / or contract. The electrical connection 9105 including the plurality of curves 9106 may be formed of stretchable conductive silicone. In some embodiments, the stretchable conductive silicone may be printed, thermally bonded, adhered, overmolded, or coated onto a wire or fiber that forms the material of the catheter headgear 4180.

[0515] Additionally or alternatively, the electrical connection 9105 can be formed from a stretchable conductive textile having printed conductive traces (such as copper traces). The stretchable conductive textile having printed conductive traces (such as copper traces) can be thermally bonded to the catheter headgear 4180, which can be formed of, for example, silicone. Additionally or alternatively, a metal gel soft circuit can be used to form the electrical connection 9105. The metal gel soft circuit can include a membrane that can be bonded to the catheter headgear 4180, which can be partially formed of silicone. Alternatively, the metal gel soft circuit can include a membrane that can be bonded to the textile. Additionally, the metal gel soft circuit can include one or more stabilizing additives to allow the material to withstand high-pressure lamination and thermal welding processes without displacement. The metal gel soft circuit can be configured to withstand bending, stretching, or twisting. Any one or combination of these materials can be used to form the electrical connection 9105 and / or one or more antennas and to bond them to the catheter headgear 4180.

[0516] Although not shown in the drawings, the conductive stretchable materials described herein can also be used to interconnect one or more sensors, electrodes, accelerometers, high-stretch strain gauges, microprocessors, and / or other circuit elements that may be present on the patient interface 3000, catheter headgear 4180, air circuit 4170, or other accessories.

[0517] During use of patient interfaces 3000, 3000', or another suitable patient interface (collectively patient interface 3000), the air circuit 4170 can be fluidly coupled to the RPT device 4000 and the catheter headgear 4180. As described above, the RPT device 4000 can be configured to supply a gas flow, such as air that may be supplemented with oxygen, to the patient interface 3000 via the air circuit 4170 and the catheter headgear 4180. The RPT device 4000 can also be configured to receive a signal from the proximal end of the air circuit 4170 once the air circuit 4170 is coupled to the catheter headgear 4180. Additionally or alternatively, the RPT device 4000 can be configured to receive a signal from the proximal end of the catheter headgear 4180 once the catheter headgear 4180 is coupled to the patient interface 3000. The signal can include information about the patient interface 3000 or an accessory. For example, a first antenna 9100A associated with the air circuit 4170 can detect a first tag 9200A in the catheter headgear 4180 and can read information about the catheter headgear 4180 associated with the first tag 9200B when the air circuit 4170 is coupled to the catheter headgear 4180. Similarly, a third antenna 9100C in the catheter headgear 4180 can detect a second tag 9200B in the patient interface 3000 and can relay information about the patient interface 3000 associated with the second tag 9200B to a second antenna 9100B that can be read by the first antenna 9100A. For example, the information can be transmitted via a transceiver 9300 to a controller of the RPT device 4000 (e.g., the central controller 4230) or a controller associated with the system 8000.

[0518] In some aspects, the received information (e.g., from tag 9200B) can be one or more of the following: for example, the type of patient interface 3000 used, characteristics of the patient interface 3000 (e.g., one or more of cushion material, cushion size, 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 to be used with, etc.), date or time stamp of use, batch identification number of the patient interface 3000, or serial identification number of the patient interface 3000. In some aspects, the received information can be one or more of patient information, such as the type of therapy or therapy settings that the patient desires to receive, or other information. In some aspects, the received information can be whether the air circuit 4170, the catheter headgear 4180, and / or an accessory device (not shown) is connected or disconnected from the patient interface 3000. Similar information about the catheter headgear 4180 can be received from tag 9200A.

[0519] The RPT device 4000 (i.e., the controller of the RPT device 4000, such as the central controller 4230, which can be incorporated as part of the RPT device 4000 or separated from the RPT device 4000) can be configured to perform actions when receiving information about the patient interface 3000 from the transceiver 9300. For example, the RPT device 4000 can automatically control the operation of the therapy provided to the patient based on the received information or signals (e.g., the therapy device controller 4240 and / or the therapy control module 4330). For example, the breathing experience can be improved by determining whether the settings of the RPT device 4000 (e.g., gas flow, humidity level, etc.) are correctly 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 more efficient therapy. In some aspects of the present 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 an incorrect type or size of patient interface or catheter headgear is being used, that the gasket of the patient interface or the entire patient interface or catheter headgear should be replaced, that the RPT device 4000 is configured with one or more incorrect settings that should be changed by the patient, or other suitable indications. The indication can be generated, for example, on one or more displays of the RPT device 4000 (e.g., the display 4294) or other components of the system 8000, to an external device such as a remote external device 4286 or a local external device 4288 (e.g., the patient's tablet, smartphone, or computer, or to a healthcare provider).

[0520] In other aspects of the present technology, in addition to the information received from other sensors or systems associated with the system 8000, the information received from the patient interface 3000 can be received by the RPT device 4000. For example, sensors or systems configured to detect air flow, pressure, air leakage, humidity, or other characteristics of the system 8000 can transmit information to the RPT device 4000. The RPT device 4000 can incorporate one or more other sensors to analyze or interpret the information received from the RFID system 9000 about the patient interface 3000 or the catheter headgear. For example, information about the type or size of the worn patient interface or how long the patient interface has been used can be received from the RFID system 9000.

[0521] System 8000 can also receive information regarding discomfort or leakage occurrence of the patient interface from other sensors or patient inputs. System 8000 can analyze this information together and can take actions based on the aggregated information. For example, if patient interface discomfort is indicated by the patient or a leakage of the patient interface is detected, then based on the information received from the RFID system 9000, the RPT device 4000 can generate the following instructions to the patient: a different size or type of patient interface or catheter headgear should be used, a different size or type of gasket should be used, or a new patient interface, catheter headgear, or gasket should be used. The instructions can include, for example, recommendations regarding the patient interface, catheter headgear, or type or size of gasket to be used or guidance on how to select a better-fitting gasket, catheter headgear, or patient interface type or size. The instructions can be generated as described above, for example, on one or more displays (such as display 4294) in the RPT device 4000 or other components of the system 8000, to an external device such as the remote external device 4286 or the local external device 4288 (e.g., the patient's tablet, smartphone, or computer, or to a healthcare provider). In other aspects, one or more settings in the RPT device 4000 can be changed based on the aggregated information received from the RFID system 9000 and other information from the system 8000.

[0522] In some aspects, the system 8000 can indicate to the patient when the patient interface, catheter headgear, or gasket has been worn for a long enough time, or is an old enough production batch identification number or serial identification number that may affect performance, and a new patient interface, catheter headgear, or gasket should be used. In some aspects, the age of the patient interface or catheter headgear or how many times the patient interface or catheter headgear has been used can result in the generation of an indicator that a new patient interface, new catheter headgear, or new gasket should be used. The system 8000 can instruct the patient to replace the patient interface, catheter headgear, or gasket. The instructions can also depend at least in part on the recommended usage period of a particular patient interface, catheter headgear, or gasket type, the type of therapy given to the patient, or one or more other factors. The instructions can be generated as described above, for example, on one or more displays in the RPT device 4000 or other components of the system 8000, to an external device such as the remote external device 4286 or the local external device 4288 (e.g., the patient's tablet, smartphone, or computer, or to a healthcare provider), or to a cloud server such as the remote external communication network 4282 and / or the local external communication network 4284 and / or the 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 accessories, etc.)).

[0523] The first antenna 9100A and the transceiver 9300 can read signals from the first tag 9200A and / or the second tag 9200B via the extended second antenna 9100B at least once during a therapy session. For example, the first tag 9200A and / or the second tag 9200B can be read at the start of the therapy, such as when the start button is pressed or when auto-start is initiated. In some aspects, if no accessory or catheter headgear 4180 is detected attached to the air circuit 4170, the RFID system 9000 can continue to read, for example, continuously or at regular intervals, until an accessory or catheter headgear 4180 is detected attached to the air circuit 4170. In some configurations of this technology, the signal from the first tag 9200A can be read periodically, such as every few seconds, minutes, or hours. In some instances of this technology, the first antenna 9100A and the transceiver 9300 can read signals from the first tag 9200A and / or the second tag 9200B according to a regular or irregular frequency. For example, the signal can be read more or less frequently at the start of the 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 therapy administered or the type of patient interface used can at least partially determine the frequency of reading the first tag 9200A and / or the second tag 9200B.

[0524] Figure 5B is a schematic diagram of a system 8000 according to certain instances. The air circuit 4170 includes a transceiver 9300' and an RFID reader 9100A'. The catheter headgear 4180 includes a tag 9200A' and an RFID reader 9100C'. The patient interface includes a tag 9200B'. In certain instances, the various discussions herein of the antenna 9100A and / or the transceiver 9300 can apply to the RFID reader 9100A', and vice versa. In certain instances, the various discussions herein of the antenna 9100B and / or the tag 9200A can apply to the tag 9200A' in a similar manner, and vice versa. In certain instances, the various discussions of the tag 9200B can apply to the tag 9200B' in a similar manner, and vice versa.

[0525] The transceiver 9300' can be configured to handle (either wired or wirelessly) communication to the RPT device 4000 or other devices.

[0526] The RFID reader 9100A' is configured for wireless communication and / or to provide power to the tag 9200A' in the catheter headgear 4180. The RFID reader 9100A' includes at least one antenna, which in certain instances can correspond to the antenna 9100A, and includes a transceiver (e.g., in the instance from Figure 5AIntegrated circuit of transceiver 9300). Tag 9200A' can be an RFID tag, which includes at least one antenna that can correspond to antenna 9100B in some instances, and an integrated circuit that can correspond to tag 9200A in some instances. Tag 9200A' can also include a non-transitory memory for storing data thereon.

[0527] Tag 9200A' is connected to RFID reader 9100C' via a wire (as discussed elsewhere herein). This wire allows the energy received by tag 9200A' to be carried to RFID reader 9100C', thereby providing wireless communication and / or power to tag 9200B' provided in patient interface 3000. RFID reader 9100C' includes at least one antenna that can correspond to antenna 9100C in some instances, and an integrated circuit including a transceiver that can be the same or similar to that in RFID reader 9100A'. Tag 9200B' can be an RFID tag including at least one antenna and an integrated circuit that can correspond to tag 9200B in some instances. Tag 9200B' can include a non-transitory memory for storing data thereon.

[0528] The reader / tag combinations herein act as air-core transformers and are air-core transformers in some instances. For example, RFID reader 9100A' is the primary winding of a first transformer and 9200A' is the secondary winding of the first transformer. Similarly, 9100C' can be the primary winding of a second transformer and 9200B' is the secondary winding of the second transformer. Thus, for example, RFID reader 9100A' is used to generate an electromagnetic field that powers tag 9200A'. The power output from RFID reader 9100A' and / or 9100C' can be modulated to transmit commands. The tags can respond to these commands by modulating their respective antenna impedances. This modulation is then detected by the corresponding RFID reader and interpreted as data.

[0529] In some aspects, compared to the wireless power required to merely read or otherwise activate the tags, the wireless power supplied from the air circuit (e.g., via RFID reader 9100A') can be relatively increased. This is because the power supplied from RFID reader 9100A' can also be used (in addition to reading tag 9200A') to power RFID reader 9100C' to read tag 9200B'. In an instance, the activation of the RF field from RFID reader 9100A' can be maintained for a relatively short amount of time, such as less than 1 second, or between 1 second and 10 seconds. The period of time for supplying wireless energy to catheter headgear 4180 can be set / determined to allow data to be read from the tags as discussed herein.

[0530] In an example, a reader included in the air circuit can be the same type as a reader included in the catheter headgear. In other examples, the readers can be different types. For example, the reader in the air circuit can be designed to have a relatively higher energy transfer value to a tag in the catheter headgear than to a tag at the patient interface.

[0531] In an example, when multiple tags are included in system 8000, they can be the same type of tag. In another example, different tags of system 8000 can be different types. For example, a tag included in the patient interface can be an active tag, while a tag included in the catheter headgear 4180 can be passive. In an example, different types of passive tags can be used.

[0532] Figure 8 Illustrated are patient interface 3000′, catheter headgear 4180, and air circuit 4170 that are in fluid communication with each other when worn by a patient. For example, catheter headgear 4180 is configured such that air circuit 4170 is coupled to catheter headgear 4180 at or near the top of the patient's head, e.g., via fitting 4190 (discussed above with respect to Figure 6 ). Air circuit 4170 can rotate relative to the catheter of headgear 4180 via fitting 4190. For example, fitting 4190 can be a rotating fitting, thereby allowing air circuit 4170 to rotate relative to catheter headgear 4180. Additionally, catheter headgear 4180 and air circuit 4170 can be angled relative to each other. For example, via fitting 4190, air circuit 4170 can be at an angle of approximately 90 degrees relative to catheter headgear 4180. Thus, in some aspects, a first antenna 9100A that can be fixed in or on the proximal portion of air circuit 4170 can be angled relative to a second antenna 9100B fixed in or on catheter headgear 4180.

[0533] As previously discussed, electrical connection 9105 physically and electrically couples second antenna 9100B to third antenna 9100C. Electrical connection 9105 can include multiple curves 9106 along first bellows section 4200A or second bellows section 4200B ( Figure 6 and Figure 7 ), thus allowing electrical connection 9105 to extend and / or contract, e.g., when first bellows section 4200A extends and / or contracts. In this way, signals from third antenna 9100C can be transmitted to second antenna 9100B via electrical connection 9105.

[0534] As discussed above, the electrical connection 9105 may include multiple curves 9106. As shown, the multiple curves 9106 may extend along a portion of the electrical connection 9105. By arranging the electrical connection 9105 to have multiple curves 9106, or for example, arranging it in such a zigzag / serpentine path, stretching or bending of the catheter headgear 4180 may result in a relatively small increase in tension on the electrical connection 9105. This may allow for the use of an electrical connection 9105 with relatively little stretch or a stretchable electrical connection 9105. Such a configuration may also reduce the chance of the electrical connection 9105 failing due to repeated stretching and / or bending cycles.

[0535] Each embodiment discussed herein may enable a user to detect the identity of the patient interface or accessory in use. In this way, information regarding the mask, accessory, patient, or prescribed therapy may be transmitted via RFID. Each embodiment may contribute to increased patient use and / or patient comfort, etc.

[0536] 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 disclosure. Considering the specification and practice of the invention disclosed herein, other embodiments of the disclosure will be apparent to those skilled in the art. The specification and examples are to be considered merely exemplary, and the true scope and spirit of the invention are indicated by the appended claims.

[0537] List of Reference Numerals

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Claims

1. A catheter headgear, comprising: An opening configured to removably couple with an air circuit; A first portion extending from the opening to a first proximal end, wherein the first proximal end is configured to couple with a patient interface; A second portion extending from the opening to a second proximal end, wherein the second proximal end is configured to couple with the patient interface; A first stretchable bellows portion extending along the length of the first portion; A second stretchable bellows portion extending along the length of the second portion; A first antenna located in a region adjacent to the opening; A second antenna spaced apart from the first antenna; And A conductive electrical connection coupling the first antenna and the second antenna, wherein the electrical connection extends along at least a portion of the first stretchable bellows portion or the second stretchable bellows portion, and wherein the electrical connection is configured to accommodate stretching of the first stretchable bellows portion or the second stretchable bellows portion.

2. The catheter headgear according to claim 1, wherein the second antenna is located in a region adjacent to the first proximal end or the second proximal end.

3. The catheter headgear according to claim 1 or 2, wherein the electrical connection has a serpentine or Z-shaped path at least where the electrical connection extends along the at least a portion of the first stretchable bellows portion or the second stretchable bellows portion.

4. The catheter headgear according to any one of claims 1 to 3, wherein the electrical connection is formed of a wire or a stretchable material.

5. The catheter headgear according to any one of claims 1 to 4, wherein the electrical connection is located on an outer surface of the first portion or the second portion.

6. The catheter headgear according to any one of claims 1 to 4, wherein the electrical connection is located within a wall of the first portion or the second portion.

7. The catheter headgear according to any one of claims 1 to 5, wherein the electrical connection is incorporated as part of a sleeve covering an outer surface of at least one of the first portion or the second portion.

8. The catheter headgear according to claim 7, wherein the sleeve is formed of a stretchable textile material.

9. The catheter headgear according to claim 7 or 8, wherein the electrical connection is in the form of a conductive trace, a conductive wire, or a metallic gel.

10. The catheter headgear according to claim 9, wherein the electrical connection is printed, thermally bonded, or stitched onto the sleeve.

11. The catheter headgear according to any one of claims 1 to 5, wherein the electrical connection is a stretchable conductive silicone or wire printed or thermally bonded to an outer surface of the first portion or the second portion.

12. The catheter headgear according to any one of claims 1 to 11, wherein the first antenna surrounds the opening.

13. A catheter headgear, comprising: An opening configured to removably couple with an air circuit; A first portion that extends from the opening to a first proximal end, where the first proximal end is configured to couple to a patient interface; A second portion that extends from the opening to a second proximal end, where the second proximal end is configured to couple to the patient interface; A first stretchable bellows portion that extends along the length of the first portion; A second stretchable bellows portion that extends along the length of the second portion; A first antenna located in an area adjacent to the opening; A second antenna spaced apart from the first antenna; And A sleeve that covers at least one of the first portion or the second portion, where the sleeve includes a conductive electrical connection that extends along the sleeve and electrically couples the first antenna and the second antenna.

14. The catheter headgear according to claim 13, wherein the sleeve is formed of a stretchable textile material.

15. The catheter headgear according to claim 13 or 14, wherein the sleeve is thermally bonded to an outer surface of at least one of the first portion or the second portion.

16. The catheter headgear according to any one of claims 13 to 15, wherein at least one of the first antenna or the second antenna is incorporated as part of the sleeve.

17. The catheter headgear according to any one of claims 13 to 16, wherein the sleeve is removably coupled to the first portion or the second portion.

18. The catheter headgear according to any one of claims 13 to 17, wherein the sleeve covers the first portion and the second portion.

19. The catheter headgear according to any one of claims 13 to 18, wherein the second antenna is located in an area adjacent to the first proximal end or the second proximal end.

20. A catheter headgear comprising: An opening configured to removably couple to an air circuit; A first portion that extends from the opening to a first proximal end, where the first proximal end is configured to couple to a patient interface; A second portion that extends from the opening to a second proximal end, where the second proximal end is configured to couple to the patient interface; A first stretchable bellows portion that extends along the length of the first portion; A second stretchable bellows portion that extends along the length of the second portion; A first antenna located in an area adjacent to the opening; A second antenna spaced apart from the first antenna; And A stretchable conductive electrical connection that electrically couples the first antenna and the second antenna, where the electrical connection extends along at least a portion of the first stretchable bellows portion or the second stretchable bellows portion.

21. The catheter headgear according to claim 20, wherein the electrical connection is formed of conductive silicone.

22. The catheter headgear according to claim 20 or 21, wherein the electrical connection is in the form of a wire or a conductor.

23. The catheter headgear according to any one of claims 20 to 22, wherein the electrical connection is printed or thermally bonded to an outer surface of the first part or the second part.

24. The catheter headgear according to any one of claims 1 to 22, wherein the first antenna is part of an RFID tag.

25. A system comprising: The catheter headgear according to any one of claims 1 to 24; A third antenna, the third antenna being electrically connected to a power source; And At least one hardware processor configured to perform operations including: Causing the third antenna to generate a first RF field, the first RF field supplying energy that is transmitted via the electrical connection to the second antenna to generate a second RF field.

26. The system according to claim 25, wherein the patient interface includes a second RFID tag, and wherein the second RF field is used to read data from the second RF field.

27. The system according to claim 26, wherein the operations further include: Performing a determination as to whether the opening of the catheter headgear has been coupled to the air circuit, and causing the third antenna to generate the first RF field based on the determination that the opening of the catheter headgear has been coupled to the air circuit.

28. A catheter headgear comprising: An opening configured to be removably coupled to an air circuit; A first part extending from the opening to a first proximal end, wherein the first proximal end is configured to be coupled to a patient interface; A second part extending from the opening to a second proximal end, wherein the second proximal end is configured to be coupled to the patient interface; A first stretchable bellows portion extending along a length of the first part; A second stretchable bellows portion extending along a length of the second part; A first RFID tag located in a region adjacent to the opening; And An RFID reader configured to communicate with a second RFID tag different from the first RFID tag; A stretchable conductive electrical connection electrically coupling the RFID tag and the RFID reader, wherein the electrical connection extends along at least a portion of the first stretchable bellows portion or the second stretchable bellows portion, wherein the first RFID tag is configured to wirelessly receive power and supply power to the RFID reader via the stretchable conductive electrical connection, thereby powering the RFID reader to communicate with the second RFID tag.

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