Devices and methods for overmolding flexible circuits

Abstract

A respiratory therapy system may comprise a patient interface and a radio frequency identification (RFID) tag fixed to the patient interface. The RFID tag may comprise a flexible circuit board. The flexible circuit board may comprise a first layer, a second layer, and a third layer. The second layer is disposed between the first layer and the third layer. The second layer includes a first surface and a second surface opposite the first surface. The first layer comprises an overlay affixed to the first surface of the second layer. The third layer comprises an overlay affixed to the second surface of the second layer. The second layer may comprise a conductive material.

Description

DEVICES AND METHODS FOR OVERMOLDING FLEXIBLE CIRCUITS1 CROSS REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to U.S. Provisional Application No. 63 / 515,681, filed July 26, 2023, which is incorporated herein by reference in its entirety.2 BACKGROUND OF THE TECHNOLOGY2.1 FIELD OF THE TECHNOLOGY

[0002] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory-related disorders. The present technology also relates to medical devices, or apparatus, systems, and their use.2.2 DESCRIPTION OF THE RELATED ART2.2.1 Human Respiratory System and its Disorders

[0003] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.

[0004] The airways include a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lung. The prime function of the lung 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 right and left main bronchi, which further divide eventually into terminal bronchioles. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli. The alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory zone. See “Respiratory Physiology" , by John B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0005] A range of respiratory disorders exist. Certain disorders may be characterised by particular events, e.g. apneas, hypopneas, and hyperpneas.

[0006] Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hyperventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest wall disorders.

[0007] Obstructive Sleep Apnea (OSA), a form of Sleep Disordered Breathing (SDB), is characterised by events including occlusion or obstruction of the upper air passage during sleep. It results from a combination of an abnormally small upper airway and the normal loss of muscle tone in the region of the tongue, soft palate and posterior oropharyngeal wall during sleep. The condition causes the affected patient to stop breathing for periods typically of 30 to 120 seconds in duration, sometimes 200 to 300 times per night. It often causes excessive daytime somnolence, and it may cause cardiovascular disease and brain damage. The syndrome is a common disorder, particularly in middle aged overweight males, although a person affected may have no awareness of the problem. See US Patent No. 4,944,310 (Sullivan).

[0008] Cheyne-Stokes Respiration (CSR) is another form of sleep disordered breathing. CSR is a disorder of a patient's respiratory controller in which there are rhythmic alternating periods of waxing and waning ventilation known as CSR cycles. CSR is characterised by repetitive de-oxygenation and re-oxygenation of the arterial blood. It is possible that CSR is harmful because of the repetitive hypoxia. In some patients CSR is associated with repetitive arousal from sleep, which causes severe sleep disruption, increased sympathetic activity, and increased afterload. See US Patent No. 6,532,959 (Berthon-Jones).

[0009] Respiratory failure is an umbrella term for respiratory disorders in which the lungs are unable to inspire sufficient oxygen or exhale sufficient CO2 to meet the patient’s needs. Respiratory failure may encompass some or all of the following disorders.

[0010] A patient with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath on exercise.

[0011] Obesity Hyperventilation Syndrome (OHS) is defined as the combination of severe obesity and awake chronic hypercapnia, in the absence of other known causes for hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness.

[0012] Chronic Obstructive Pulmonary Disease (COPD) encompasses any of a group of lower airway diseases that have certain characteristics in common. These include increased resistance to air movement, extended expiratory phase of respiration, and lossof the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (primary risk factor), occupational exposures, air pollution and genetic factors. Symptoms include: dyspnea on exertion, chronic cough and sputum production.

[0013] Neuromuscular Disease (NMD) is a broad term that encompasses many diseases and ailments that impair the functioning of the muscles either directly via intrinsic muscle pathology, or indirectly via nerve pathology. Some NMD patients are characterised by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, swallowing difficulties, respiratory muscle weakness and, eventually, death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: Characterised by muscle impairment that worsens over months and results in death within a few years (e.g. Amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: Characterised by muscle impairment that worsens over years and only mildly reduces life expectancy (e.g. Limb girdle, Facioscapulohumeral and Myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing generalised weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, morning headache, and difficulties with concentration and mood changes.

[0014] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling between the respiratory muscles and the thoracic cage. The disorders are usually characterised by a restrictive defect and share the potential of long term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis may cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea on exertion, peripheral oedema, orthopnea, repeated chest infections, morning headaches, fatigue, poor sleep quality and loss of appetite.

[0015] A range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals may take advantage of such therapies to prevent respiratory disorders from arising. However, these have a number of shortcomings.2.2.2 Therapies

[0016] Various respiratory therapies, such as Continuous Positive Airway Pressure (CPAP) therapy, Non-invasive ventilation (NIV), Invasive ventilation (IV), and High Flow Therapy (HFT) have been used to treat one or more of the above respiratory disorders.2.2.2.1 Respiratory pressure therapies

[0017] Respiratory pressure therapy is the application of a supply of air to an entrance to the airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the patient’s breathing cycle (in contrast to negative pressure therapies such as the tank ventilator or cuirass).

[0018] 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 may prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy may be voluntary, and hence patients may elect not to comply with therapy if they find devices used to provide such therapy one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing.

[0019] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airways to assist the patient breathing and / or maintain adequate oxygen levels in the body by doing 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, in forms such as OHS, COPD, NMD and Chest Wall disorders. In some forms, the comfort and effectiveness of these therapies may be improved.

[0020] Invasive ventilation (IV) provides ventilatory support to patients that are no longer able to effectively breathe themselves and may be provided using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies may be improved.2.2.2.2 Flow therapies

[0021] Not all respiratory therapies aim to deliver a prescribed therapeutic pressure. Some respiratory therapies aim to deliver a prescribed respiratory volume, by deliveringan inspiratory flow rate profile over a targeted duration, possibly superimposed on a positive baseline pressure. In other cases, the interface to the patient’s airways is ‘open’ (unsealed) and the respiratory therapy may only supplement the patient’s own spontaneous breathing with a flow of conditioned or enriched gas. In one example, High Flow therapy (HFT) is the provision of a continuous, heated, humidified flow of air to an entrance to the airway through an unsealed or open patient interface at a “treatment flow rate” that may be held approximately constant throughout the respiratory cycle. The treatment 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 rate of air at the airway entrance improves ventilation efficiency by flushing, or washing out, expired CO2 from the patient’s anatomical deadspace. Hence, HFT is thus sometimes referred to as a deadspace therapy (DST). Other benefits may include the elevated warmth and humidification (possibly of benefit in secretion management) and the potential for modest elevation of airway pressures. As an alternative to constant flow rate, the treatment flow rate may follow a profile that varies over the respiratory cycle.

[0022] Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. Doctors may prescribe a continuous flow of oxygen enriched air at a specified oxygen concentration (from 21%, the oxygen fraction in ambient air, to 100%) at a specified flow rate (e.g., 1 litre per minute (LPM), 2 LPM, 3 LPM, etc.) to be delivered to the patient’s airway.2.2.23 Supplementary oxygen

[0023] For certain patients, oxygen therapy may be combined with a respiratory pressure therapy or HFT by adding supplementary oxygen to the pressurised flow of air. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplementary oxygen. When oxygen is added to HFT, the resulting therapy is referred to as HFT with supplementary oxygen.2.23 Respiratory Therapy Systems

[0024] These respiratory therapies may be provided by a respiratory therapy system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it.

[0025] A respiratory therapy system may comprise a Respiratory Pressure Therapy Device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0026] Another form of therapy system is a mandibular repositioning device.2.2.3.1 Patient Interface

[0027] A patient interface may be used to interface respiratory equipment to its wearer, for example by providing a flow of air to an entrance to the airways. The flow of air may be provided via a mask to the nose and / or mouth, a tube to the mouth or a tracheostomy tube to the trachea of a patient. Depending upon the therapy to be applied, the patient interface may form a seal, e.g., with a region of the patient's face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, e.g., at a positive pressure of about 10 cmH20 relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the patient interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cmH20. For flow therapies such as nasal HFT, the patient interface is configured to insufflate the nares but specifically to avoid a complete seal. One example of such a patient interface is a nasal cannula.

[0028] Certain other mask systems may be functionally unsuitable for the present field. For example, purely ornamental masks may be unable to maintain a suitable pressure. Mask systems used for underwater swimming or diving may be configured to guard against ingress of water from an external higher pressure, but not to maintain air internally at a higher pressure than ambient.

[0029] Certain masks may be clinically unfavourable for the present technology e.g. if they block airflow via the nose and only allow it via the mouth.

[0030] Certain masks may be uncomfortable or impractical for the present technology if they require a patient to insert a portion of a mask structure in their mouth to create and maintain a seal via their lips.

[0031] Certain masks may be impractical for use while sleeping, e.g. for sleeping while lying on one’s side in bed with a head on a pillow.

[0032] The design of a patient interface presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of noses and heads variesconsiderably between individuals. Since the head includes bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces. The jaw or mandible may move relative to other bones of the skull. The whole head may move during the course of a period of respiratory therapy.

[0033] As a consequence of these challenges, some masks suffer from being one or more of obtrusive, aesthetically undesirable, costly, poorly fitting, difficult to use, and uncomfortable especially when worn for long periods of time or when a patient is unfamiliar with a system. Wrongly sized masks can give rise to reduced compliance, reduced comfort and poorer patient outcomes. Masks designed solely for aviators, masks designed as part of personal protection equipment (e.g. filter masks), SCUBA masks, or for the administration of anaesthetics may be tolerable for their original application, but nevertheless such masks may be undesirably uncomfortable to be worn for extended periods of time, e.g., several hours. This discomfort may lead to a reduction in patient compliance with therapy. This is even more so if the mask is to be worn during sleep.

[0034] CPAP therapy is highly effective to treat certain respiratory disorders, provided patients comply with therapy. If a mask is uncomfortable, or difficult to use a patient may not comply with therapy. Since it is often recommended that a patient regularly wash their mask, if a mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their mask and this may impact on patient compliance.

[0035] While a mask for other applications (e.g. aviators) may not be suitable for use in treating sleep disordered breathing, a mask designed for use in treating sleep disordered breathing may be suitable for other applications.

[0036] For these reasons, patient interfaces for delivery of CPAP during sleep form a distinct field.2.2.3.1.1 Seal-forming structure

[0037] Patient interfaces may include a seal-forming structure. Since it is in direct contact with the patient’s face, the shape and configuration of the seal-forming structure can have a direct impact the effectiveness and comfort of the patient interface.

[0038] A patient interface may be partly characterised according to the design intent of where the seal-forming structure is to engage with the face in use. In one form ofpatient interface, a seal-forming structure may comprise a first sub-portion to form a seal around the left naris and a second sub-portion to form a seal around the right naris. In one form of patient interface, a seal-forming structure may comprise a single element that surrounds both nares in use. Such single element may be designed to for example overlay an upper lip region and a nasal bridge region of a face. In one form of patient interface a seal-forming structure may comprise an element that surrounds a mouth region in use, e.g. by forming a seal on a lower lip region of a face. In one form of patient interface, a seal-forming structure may comprise a single element that surrounds both nares and a mouth region in use. These different types of patient interfaces may be known by a variety of names by their manufacturer including nasal masks, full-face masks, nasal pillows, nasal puffs and oro-nasal masks.

[0039] A seal-forming structure that may be effective in one region of a patient’s face may be inappropriate in another region, e.g. because of the different shape, structure, variability and sensitivity regions of the patient’s face. For example, a seal on swimming goggles that overlays a patient’s forehead may not be appropriate to use on a patient’s nose.

[0040] Certain seal-forming structures may be designed for mass manufacture such that one design fit and be comfortable and effective for a wide range of different face shapes and sizes. To the extent to which there is a mismatch between the shape of the patient’s face, and the seal-forming structure of the mass-manufactured patient interface, one or both must adapt in order for a seal to form.

[0041] One type of seal-forming structure extends around the periphery of the patient interface, and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure in confronting engagement with the patient's face. The seal-forming structure may include an air or fluid filled cushion, or a molded or formed surface of a resilient seal element made of an elastomer such as a rubber. With this type of seal-forming structure, if the fit is not adequate, there will be gaps between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face in order to achieve a seal.

[0042] Another type of seal-forming structure incorporates a flap seal of thin material positioned about the periphery of the mask so as to provide a self-sealing actionagainst the face of the patient when positive pressure is applied within the mask. Like the previous style of seal forming portion, if the match between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak.Furthermore, if the shape of the seal-forming structure does not match that of the patient, it may crease or buckle in use, giving rise to leaks.

[0043] Another type of seal-forming structure may comprise a friction-fit element, e.g. for insertion into a naris, however some patients find these uncomfortable.

[0044] Another form of seal-forming structure may use adhesive to achieve a seal. Some patients may find it inconvenient to constantly apply and remove an adhesive to their face.

[0045] A range of patient interface seal-forming structure technologies are disclosed in the following patent applications, assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0046] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow, or nasal puff is the subject of US Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0047] ResMed Limited has manufactured the following products that incorporate nasal pillows: SWIFTTM nasal pillows mask, SWIFTTM II nasal pillows mask, SWIFTTM LT nasal pillows mask, SWIFTTM FX nasal pillows mask and MIRAGE LIBERTYTM full-face mask. The following patent applications, assigned to ResMed Limited, describe examples of nasal pillows masks: International Patent Application W02004 / 073,778 (describing amongst other things aspects of the ResMed Limited SWIFTTM nasal pillows), US Patent Application 2009 / 0044808 (describing amongst other things aspects of the ResMed Limited SWIFTTM LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (describing amongst other things aspects of the ResMed Limited MIRAGE LIBERTYTM full-face mask);International Patent Application WO 2009 / 052,560 (describing amongst other things aspects of the ResMed Limited SWIFTTM FX nasal pillows).2.2.3.1.2 Positioning and stabilising

[0048] A seal-forming structure of a patient interface used for positive air pressure therapy is subject to the corresponding force of the air pressure to disrupt a seal. Thus, avariety of techniques have been used to position the seal-forming structure, and to maintain it in sealing relation with the appropriate portion of the face.

[0049] One technique is the use of adhesives. See for example US Patent Application Publication No. US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some.

[0050] Another technique is the use of one or more straps and / or stabilising harnesses. Many such harnesses suffer from being one or more of ill-fitting, bulky, uncomfortable and awkward to use.2.23.2 Respiratory Pressure Therapy (RPT) Device

[0051] A respiratory pressure therapy (RPT) device may be used individually or as part of a system to deliver one or more of a number of therapies described above, such as by operating the device to generate a flow of air for delivery to an interface to the airways. The flow of air may be pressure-controlled (for respiratory pressure therapies) or flow-controlled (for flow therapies such as HFT). Thus, RPT devices may also act as flow therapy devices. Examples of RPT devices include a CPAP device and a ventilator.

[0052] Air pressure generators are known in a range of applications, e.g. industrialscale ventilation systems. However, air pressure generators for medical applications have particular requirements not fulfilled by more generalised air pressure generators, such as the reliability, size and weight requirements of medical devices. In addition, even devices designed for medical treatment may suffer from shortcomings, pertaining to one or more of: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.

[0053] An example of the special requirements of certain RPT devices is acoustic noise.

[0054] Table of noise output levels of prior RPT devices (one specimen only, measured using test method specified in ISO 3744 in CPAP mode at 10 cmH20).

[0055] One known RPT device used for treating sleep disordered breathing is the S9 Sleep Therapy System, manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators such as the ResMed Stellar™ Series of Adult and Paediatric Ventilators may provide support for invasive and non-invasive non-dependent ventilation for a range of patients for treating a number of conditions such as but not limited to NMD, OHS and COPD.

[0056] The ResMed Elisee™ 150 ventilator and ResMed VS III™ ventilator may provide support for invasive and non-invasive dependent ventilation suitable for adult or paediatric patients for treating a number of conditions. These ventilators provide volumetric and barometric ventilation modes with a single or double limb circuit. RPT devices typically comprise a pressure generator, such as a motor-driven blower or a compressed gas reservoir, and are configured to supply a flow of air to the airway of a patient. In some cases, the flow of air may be supplied to the airway of the patient at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0057] The designer of a device may be presented with an infinite number of choices to make. Design criteria often conflict, meaning that certain design choices are far from routine or inevitable. Furthermore, the comfort and efficacy of certain aspects may be highly sensitive to small, subtle changes in one or more parameters.2.2.3.3 Air circuit

[0058] An air circuit is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components of a respiratory therapy system such as the RPT device and the patient interface. In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation.2.2.3.4 Humidifier

[0059] Delivery of a flow of air without humidification may cause drying of airways. The use of a humidifier with an RPT device and the patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. Inaddition, in cooler climates, warm air applied generally to the face area in and about the patient interface is more comfortable than cold air.

[0060] A range of artificial humidification devices and systems are known, however they may not fulfil the specialised requirements of a medical humidifier.

[0061] Medical humidifiers are used to increase humidity and / or temperature of the flow of air in relation to ambient air when required, typically where the patient may be asleep or resting (e.g. at a hospital). A medical humidifier for bedside placement may be small. A medical humidifier may be configured to only humidify and / or heat the flow of air delivered to the patient without humidifying and / or heating the patient’s surroundings. Room-based systems (e.g. a sauna, an air conditioner, or an evaporative cooler), for example, may also humidify air that is breathed in by the patient, however those systems would also humidify and / or heat the entire room, which may cause discomfort to the occupants. Furthermore, medical humidifiers may have more stringent safety constraints than industrial humidifiers

[0062] While a number of medical humidifiers are known, they can suffer from one or more shortcomings. Some medical humidifiers may provide inadequate humidification, some are difficult or inconvenient to use by patients.2.23.5 Oxygen source

[0063] Experts in this field have recognized that exercise for respiratory failure patients provides long term benefits that slow the progression of the disease, improve quality of life and extend patient longevity. Most stationary forms of exercise like tread mills and stationary bicycles, however, are too strenuous for these patients. As a result, the need for mobility has long been recognized. Until recently, this mobility has been facilitated by the use of small compressed oxygen tanks or cylinders mounted on a cart with dolly wheels. The disadvantage of these tanks is that they contain a finite amount of oxygen and are heavy, weighing about 50 pounds when mounted.

[0064] Oxygen concentrators have been in use for about 50 years to supply oxygen for respiratory therapy. Traditional oxygen concentrators have been bulky and heavy making ordinary ambulatory activities with them difficult and impractical. Recently, companies that manufacture large stationary oxygen concentrators began developing portable oxygen concentrators (POCs). The advantage of POCs is that they can produce atheoretically endless supply of oxygen. In order to make these devices small for mobility, the various systems necessary for the production of oxygen enriched gas are condensed. POCs seek to utilize their produced oxygen as efficiently as possible, in order to minimise weight, size, and power consumption. This may be achieved by delivering the oxygen as series of pulses, each pulse or “bolus” timed to coincide with the onset of inhalation. This therapy mode is known as pulsed oxygen delivery (POD) or demand mode, in contrast with traditional continuous flow delivery more suited to stationary oxygen concentrators.2.2.3.6 Data Management

[0065] There may be clinical reasons to obtain data to determine whether the patient prescribed with respiratory therapy has been “compliant”, e.g. that the patient has used their RPT device according to one or more “compliance rules”. One example of a compliance rule for CPAP therapy is that a patient, in order to be deemed compliant, is required to use the RPT device for at least four hours a night for at least 21 of 30 consecutive days. In order to determine a patient's compliance, a provider of the RPT device, such as a health care provider, may manually obtain data describing the patient's therapy using the RPT device, calculate the usage over a predetermined time period, and compare with the compliance rule. Once the health care provider has determined that the patient has used their RPT device according to the compliance rule, the health care provider may notify a third party that the patient is compliant.

[0066] There may be other aspects of a patient’s therapy that would benefit from communication of therapy data to a third party or external system.

[0067] Existing processes to communicate and manage such data can be one or more of costly, time-consuming, and error-prone.2.2.3.7 Vent technologies

[0068] Some forms of treatment systems may include a vent to allow the washout of exhaled carbon dioxide. The vent may allow a flow of gas from an interior space of a patient interface, e.g., the plenum chamber, to an exterior of the patient interface, e.g., to ambient.

[0069] The vent may comprise an orifice and gas may flow through the orifice in use of the mask. Many such vents are noisy. Others may become blocked in use and thusprovide insufficient washout. Some vents may be disruptive of the sleep of a bed partner 1100 of the patient 1000, e.g. through noise or focussed airflow.

[0070] ResMed Limited has developed a number of improved mask vent technologies. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; US Patent No. 6,581,594; US Patent Application Publication No. US 2009 / 0050156; US Patent Application Publication No. 2009 / 0044808.

[0071] Table of noise of prior masks (ISO 17510-2:2007, 10 cmH20 pressure at Im)

[0072] (* one specimen only, measured using test method specified in ISO 3744 inCPAP mode at 10 cmH20)

[0073] Sound pressure values of a variety of objects are listed below:2.2.4 Screening, Diagnosis, and Monitoring Systems

[0074] Polysomnography (PSG) is a conventional system for diagnosis and monitoring of cardio-pulmonary disorders, and typically involves expert clinical staff to apply the system. PSG typically involves the placement of 15 to 20 contact sensors on a patient in order to record various bodily signals such as electroencephalography (EEG), electrocardiography (ECG), electrooculograpy (EOG), electromyography (EMG), etc. PSG for sleep disordered breathing has involved two nights of observation of a patient in a clinic, one night of pure diagnosis and a second night of titration of treatment parameters by a clinician. PSG is therefore expensive and inconvenient. In particular, it is unsuitable for home screening / diagnosis / monitoring of sleep disordered breathing.

[0075] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically gives a true / false result indicating whether or not a patient’s SDB is severe enough to warrant further investigation, while diagnosis may result in clinically actionable information. Screening and diagnosis tend to be one-off processes, whereas monitoring the progress of a condition can continue indefinitely. Some screening / diagnosis systems are suitable only for screening / diagnosis, whereas some may also be used for monitoring.

[0076] Clinical experts may be able to screen, diagnose, or monitor patients adequately based on visual observation of PSG signals. However, there are circumstances where a clinical expert may not be available, or a clinical expert may not be affordable. Different clinical experts may disagree on a patient’s condition. In addition, a given clinical expert may apply a different standard at different times.3 BRIEF SUMMARY OF THE TECHNOLOGY

[0077] The present technology is directed towards providing medical devices used in the screening, diagnosis, monitoring, amelioration, treatment, or prevention of respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0078] A first aspect of the present technology relates to apparatus used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0079] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0080] An aspect of certain forms of the present technology is to provide methods and / or apparatus that improve the compliance of patients with respiratory therapy.

[0081] One form of the present technology comprises a positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head. The positioning and stabilising structure includes at least one strap.

[0082] One form of the present technology comprises a patient interface comprising a plenum chamber, a seal-forming structure, and a positioning and stabilising structure.

[0083] One form of the present technology comprises patient interface comprising a plenum chamber pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure. The plenum chamber includes at least one plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient. The patient interface also comprises a seal-forming structure that is constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways. The seal-forming structure has a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient’s nares. The seal-forming structure is constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’ s respiratory cycle in use. The patient interface also comprises a positioning and stabilising structure to providea force to hold the seal-forming structure in a therapeutically effective position on the patient’s head.

[0084] Another aspect of one form of the present technology is a series of modular elements that may be interconnected in order to form different styles of patient interfaces.

[0085] In one form, there are at least two versions or styles of each modular element. The versions or styles may be interchangeably used with one another in order to form different modular assemblies.

[0086] One form of the present technology comprises a respiratory therapy system, comprising: a patient interface; an air circuit configured to removably couple to the patient interface; a radio frequency identification (RFID) tag associated with the patient interface, the RFID tag being configured to store information about the patient interface; an antenna; and a transceiver, wherein the transceiver may be configured to wirelessly receive the information stored on the RFID tag when the air circuit may be coupled to the patient interface and to transmit the information to a controller.

[0087] In an aspect of the present technology, a radio frequency identification (RFID) tag and / or an antenna may be fixed to a patient interface and / or air circuit. One or both of the RFID tag and / or the antenna may comprise a flexible circuit board. The flexible circuit board may include a first layer, a second layer, and a third layer. The second layer may be disposed between the first layer and the third layer. The second layer may include a first surface and a second surface opposite the first surface. The first layer may comprise an overlay affixed to the first surface of the second layer. The third layer may comprise an overlay affixed to the second surface of the second layer. The second layer may comprise a conductive material. In some aspects, the flexible circuit board of the RFID tag and / or the antenna may each include additional layers (e.g., four layers, five layers, six layers, etc.). For example, the flexible circuit board may include additional overlay layers and / or additional conductive material layers. In some aspects, the RFID tag and / or the antenna may each include additional flexible circuit boards (e.g., two circuit boards, three circuit boards, etc.).

[0088] In aspects, the first layer and / or the third layer may comprise polyimide or another amorphous plastic, thermoplastic polyurethanes, polyethylene terephthalate, and / or a silicone film.

[0089] In some aspects, the first layer and / or the third layer may include an outer surface having an improved bonding strength, improved adhesion capabilities, a higher surface roughness and / or improved coupling capabilities relative to an inner surface thereof, wherein the inner surface thereof is affixed to the second layer.

[0090] In some aspects, the first layer and / or the third layer comprises a plasma treatment or corona treatment on an outer surface thereof. The first layer and / or the third layer may include an etching configured to roughen an outer surface thereof.

[0091] In some aspects, the first layer and / or the third layer may comprise one or more features on an outer surface thereof. The one or more features may include an indentation and / or a projection. In some aspects, the one or more features may include the projection, and the projection may have a frustoconical shape, an L shape, and / or a mushroom shape.

[0092] In some aspects, the first layer and / or the third layer may have at least one through hole extending therethrough. The at least one through hole may extend through the first layer, the second layer, and the third layer.

[0093] In some aspects, a silicone material may at least partially surround the flexible circuit board. In some aspects, the flexible circuit board is encapsulated.

[0094] In another aspect, a radio frequency identification (RFID) tag may be fixed to a patient interface. The RFID tag may include a flexible circuit board. The flexible circuit board may include a first layer, a second layer, and a third layer. The second layer may be disposed between the first layer and the third layer. The second layer may include a first surface and a second surface opposite the first surface. The first layer may comprise an overlay affixed to the first surface of the second layer. The third layer may comprise an overlay affixed to the second surface of the second layer. The second layer may comprise a conductive material.

[0095] In another aspect, a radio frequency identification (RFID) tag may be fixed to an air circuit. The RFID tag may include a flexible circuit board. The flexible circuit board may include a first layer, a second layer, and a third layer. The second layer may be disposed between the first layer and the third layer. The second layer may include a first surface and a second surface opposite the first surface. The first layer may comprise an overlay affixed to the first surface of the second layer. The third layer may comprise anoverlay affixed to the second surface of the second layer. The second layer may comprise a conductive material.

[0096] In some aspects, the first layer and / or the third layer may include polyimide or another amorphous plastic, thermoplastic polyurethanes, polyethylene terephthalate, and / or a silicone film.

[0097] In some aspects, the first layer and / or the third layer may include an outer surface having an improved bonding strength, improved adhesion capabilities, a higher surface roughness and / or improved coupling capabilities relative to an inner surface thereof, wherein the inner surface thereof is affixed to the second layer.

[0098] In one form, the first layer and / or the third layer may comprise a plasma treatment or corona treatment on an outer surface thereof. The first layer and / or the third layer may include an etching configured to roughen an outer surface thereof.

[0099] In some aspects, the first layer and / or the third layer may comprise one or more features on an outer surface thereof. The one or more features may include an indentation and / or a projection in some aspects.

[0100] In some forms, the projection may have a frustoconical shape, an L shape, and / or a mushroom shape.

[0101] In some aspects, the first layer and / or the third layer may have at least one through hole extending therethrough. The at least one through hole may extend through the first layer, the second layer, and the third layer in some aspects.

[0102] In some aspects, a silicone material may at least partially surround the flexible circuit board. In some forms, the flexible circuit board may be encapsulated.

[0103] Of course, portions of the aspects may form sub-aspects of the present technology. Also, various ones of the sub-aspects and / or aspects may be combined in various manners and also constitute additional aspects or sub-aspects of the present technology.

[0104] Other features of the technology will be apparent from consideration of the information contained in the following detailed description, abstract, drawings and claims.4 BRIEF DESCRIPTION OF THE DRAWINGS

[0105] The present technology is illustrated by way of example, and not by way of limitation, in the Figures of the accompanying drawings, in which like reference numerals refer to similar elements including:

[0106] Figs. 1A-1C each illustrate various configurations of a respiratory therapy system in use.

[0107] Fig. 2 shows a patient interface in the form of a nasal mask in accordance with one form of the present technology.

[0108] Fig. 3A shows a cushion for a mask that includes two pillows. An exterior surface of the cushion is indicated. An edge of the surface is indicated. Dome and saddle regions are indicated.

[0109] Fig. 3B shows a cushion for a mask. An exterior surface of the cushion is indicated. An edge of the surface is indicated. A path on the surface between points A and B is indicated. A straight line distance between A and B is indicated. Two saddle regions and a dome region are indicated.

[0110] Fig. 3C shows the surface of a structure, with a one dimensional hole in the surface. The illustrated plane curve forms the boundary of a one dimensional hole.

[0111] Fig. 3D shows a cross-section through the structure of Fig.3C. The illustrated surface bounds a two dimensional hole in the structure of Fig. 3C.

[0112] Fig. 3E shows a perspective view of the structure of Fig. 3C, including the two dimensional hole and the one dimensional hole. Also shown is the surface that bounds a two dimensional hole in the structure of Fig. 3C.

[0113] Fig. 3F shows a mask having an inflatable bladder as a cushion.

[0114] Fig. 3G shows a cross-section through the mask of Fig. 3F, and shows the interior surface of the bladder. The interior surface bounds the two dimensional hole in the mask.

[0115] Fig. 3H shows a further cross-section through the mask of Fig. 3F. The interior surface is also indicated.

[0116] Fig. 4A is a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology. The directions of upstream and downstream are indicated with reference to the blower and the patient interface. Theblower is defined to be upstream of the patient interface and the patient interface is defined to be downstream of the blower, regardless of the actual flow direction at any particular moment. Items which are located within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0117] Fig. 4B is a schematic diagram of the electrical components of an RPT device in accordance with one form of the present technology.

[0118] Fig. 4C is a schematic diagram of the algorithms implemented in an RPT device in accordance with one form of the present technology.

[0119] Fig. 5 A shows a perspective view of a cushion of a patient interface configured to be worn by a patient and convey pressurized air to the patient’s nose and the patient’s mouth.

[0120] Fig. 5B shows a perspective view of a cushion of a patient interface configured to be worn by a patient and convey pressurized air to the patient’s nose.

[0121] Fig. 5C shows a perspective view of tubes usable with either the cushion of Fig. 5 A or the cushion of Fig. 5B.

[0122] Fig. 5D shows a perspective view of rigidiser arms usable with either the cushion of Fig. 5 A of the cushion of Fig. 5B.

[0123] Fig. 5E shows a perspective view of headgear straps usable with the cushion of Fig. 5A.

[0124] Fig. 5F shows a perspective view of headgear straps usable with the cushion of Fig. 5B.

[0125] Fig. 5G shows a front view of a pair of sleeves that is removably fitted to either the tubes of Fig. 5C or the rigidiser arms of Fig. 5D.

[0126] Fig. 5H shows a front view of a full sleeve that is removably fitted to the rigidiser arms of Fig. 5D.

[0127] Fig. 51 shows a front perspective view of yet another alternate form of a full sleeve that is removably fitted to the rigidiser arms of Fig. 5D.

[0128] Fig. 5J is a front view of a patient wearing the cushion of Fig. 5A connected to the tubes of Fig. 5C, the headgear straps of Fig. 5E, and the sleeves of Fig. 5G.

[0129] Fig. 5K is a front view of a patient wearing the cushion of Fig. 5A connected to the rigidiser arms of Fig. 5D, the headgear straps of Fig. 5E, and the sleeve of Fig. 5H.

[0130] Fig. 5L is a front view of a patient wearing the cushion of Fig. 5B connected to the conduit headgear of Fig. 5C, and the headgear straps of Fig. 5F.

[0131] Fig. 5M is a front view of a patient wearing the cushion of Fig. 5B connected to the rigidisier arms of Fig. 5D, the headgear straps of Fig. 5F, and the sleeve of Fig. 51.

[0132] Fig. 5N is an isolated perspective view of the vent of Fig. 5L.

[0133] Fig. 50 is an isolated perspective view of a portion of the air circuit of Fig.5M.

[0134] Fig. 5P is a schematic view illustrating the possible combinations of the patient interfaces.

[0135] Fig. 6 illustrates a schematic view of a medical system, according to aspects of this disclosure.

[0136] Fig. 7A and 7B illustrate a perspective view (Fig. 7A) and a side cross- sectional view (Fig. 7B) of an exemplary flexible circuit board.

[0137] Fig. 8A and 8B illustrate a perspective view (Fig. 8 A) and a side cross- sectional view (Fig. 8B) of an alternative exemplary flexible circuit board.

[0138] Fig. 8C illustrates a side cross-sectional view of an alternative exemplary flexible circuit board.

[0139] Figs. 9A-9C illustrate perspective views of an alternative exemplary flexible circuit board (Fig. 9A) and exemplary protrusions (Figs. 9B-9C).

[0140] Fig. 10A and 10B illustrate a perspective view (Fig. 10A) and a side cross- sectional view (Fig. 10B) of an alternative exemplary flexible circuit board.

[0141] Fig. 10C-10E illustrate perspective cross-sectional views of exemplary through holes.

[0142] Fig. 11 illustrates an exemplary encapsulated circuit board.

[0143] Fig. 12 illustrates a flow chart of an exemplary method of forming the encapsulated circuit board shown in Fig. 11.

[0144] Fig. 13 is a side view of an alternative encapsulated board.

[0145] Figs. 14A and 14B illustrate a front view (Fig. 14A) and a side view (Fig. 14B) of an exemplary patient interface, according to aspects of this disclosure.

[0146] Figs. 15A and 15B illustrate a back view (Fig. 15A) and a top view (Fig. 15B) of an alternative exemplary patient interface.

[0147] Figs. 16A and 16B illustrate a perspective cross-sectional view (Fig. 16A) and a front cross-sectional view (Fig. 16B) of an exemplary headgear tube.

[0148] Figs. 17A and 17B illustrate a perspective cross-sectional view (Fig. 17A) and a front cross-sectional view (Fig. 17B) of an exemplary headgear tube.

[0149] Fig. 18 illustrates a perspective view of a headgear tube in an exemplary embodiment, according to aspects of this disclosure.

[0150] Fig. 19 illustrates a perspective view of a headgear tube in an exemplary embodiment, according to aspects of this disclosure.

[0151] Fig. 20 illustrates an exemplary configuration of antennas and tags in use, according to aspects of this disclosure.5 DETAILED DESCRIPTION OF EXAMPLES OF THETECHNOLOGY

[0152] Before the present technology is described in further detail, it is to be understood that the technology is not limited to the particular examples described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting.

[0153] The following description is provided in relation to various examples which may share one or more common characteristics and / or features. It is to be understood that one or more features of any one example may be combinable with one or more features of another example or other examples. In addition, any single feature or combination of features in any of the examples may constitute a further example.

[0154] 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 numbers will be used through the drawings to refer to the same or like parts. The term “distal” refers to a portion farthest away from a user (e.g., patient). By contrast, the term “proximal” refers to a portion closest to the user.

[0155] Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features, as claimed. As used herein, the terms “comprises,” “comprising,” “having,” “including,” or other variations thereof, are intended to cover a 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 a process, method, article, or apparatus. In this disclosure, relative terms, such as, for example, “about,” “substantially,” “generally,” and “approximately” are used to indicate a possible variation of ±10% in a stated value or characteristic.5.1 THERAPY

[0156] In one form, the present technology comprises a method for treating a respiratory disorder comprising applying positive pressure to the entrance of the airways of a patient 1000.

[0157] In certain examples of the present technology, a supply of air at positive pressure is provided to the nasal passages of the patient via one or both nares.

[0158] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.5.2 RESPIRATORY THERAPY SYSTEMS

[0159] In one form, the present technology comprises a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may comprise an RPT device 4000 for supplying a flow of air to the patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0160] Fig. 1A shows a respiratory therapy system including a patient 1000 wearing a patient interface 3000, in the form of nasal pillows, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient is sleeping in a supine sleeping position.

[0161] Fig. IB shows an alternative configuration of the respiratory therapy system including a patient 1000 wearing a patient interface 3000, in the form of a nasal mask, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPTdevice is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000.

[0162] Fig. 1C shows an further alternative configuration of the respiratory therapy system including a patient 1000 wearing a patient interface 3000, in the form of a fullface mask, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. The patient is sleeping in a side sleeping position.

[0163] An RPT device 4000 in accordance with one aspect of the present technology comprises mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300, such as any of the methods, in whole or in part, described herein. The RPT device 4000 may be configured to generate a flow of air for delivery to a patient’s airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.

[0164] In one form, the RPT device 4000 is constructed and arranged to be capable of delivering a flow of air in a range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH20, or at least 10cmH2O, or at least 20 cmH20.

[0165] As shown in Figs. 1A, IB, and 1C, patient 1000 may use the respiratory therapy system in a variety of positions. Accordingly, a position of patient interface 3000, for example, relative to air circuit 4170 or other aspects of the respiratory therapy system may vary throughout use.5.3 PATIENT INTERFACE

[0166] A non-invasive patient interface 3000, such as that shown in Fig. 2, in accordance with one aspect of the present technology comprises the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilising structure 3300, a vent 3400, one form of connection port 3600 for connection to air circuit 4170, and a forehead support 3700. In some forms a functional aspect may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient so as to maintain positive pressure at the entrance(s) to the airways of the patient 1000. The sealed patient interface 3000 is therefore suitable for delivery of positive pressure therapy.5.3.1 Cushion Surfaces

[0167] Fig. 3A shows an exemplary seal-forming structure (e.g., a cushion) for a mask that includes t-wo pillows. An exterior surface of the cushion is indicated. An edge of the surface is indicated. Dome and saddle regions are indicated.

[0168] Fig. 3B shows an alternative exemplary seal-forming cushion for a mask. An exterior surface of the cushion is indicated. An edge of the surface is indicated. A path on the surface between points A and B is indicated. A straight line distance between A and B is indicated. Two saddle regions and a dome region are indicated.

[0169] As shown in Figs. 3A and 3B, the external surfaces of each exemplary cushion includes various positive and negative curvatures, thus producing a complex three-dimensional shape. For example, the indicated dome regions may include negative curvatures. The indicated saddle regions may include positive and negative curvatures. A cushion may include multiple dome and saddle region. Furthermore, the cushion may be comprised of a soft, pliable material capable of confirming to a patient’s face or nasal passageway. In such a way, the positive and negative curvatures of the cushion may change during use. For example, the dome and / or saddle regions may become more or less pronounced.

[0170] As shown in Fig. 3C, a surface may have a one-dimensional hole, e.g. a hole bounded by a plane curve or by a space curve. Thin structures (e.g. a membrane) with a hole, may be described as having a one-dimensional hole. See for example the onedimensional hole in the surface of structure shown in Fig. 3C, bounded by a plane curve. A one-dimensional hole may be formed on one or more aspects of the respiratory therapy systems described herein. For example, a one-dimensional hole may be formed on any thin planar structure of the respiratory therapy system.

[0171] As shown in Figs 3F-3H, a structure may have a two-dimensional hole, e.g. a hole bounded by a surface. For example, an inflatable tyre has a two dimensional hole bounded by the interior surface of the tyre. In another example, a bladder with a cavity for air or gel could have a two-dimensional hole. See, for example, the cushion of Fig. 3F and the example cross-sections therethrough in Fig. 3G and Fig. 3H, with the interior surface bounding a two dimensional hole indicated.

[0172] Fig. 3D shows a cross-section through the structure of Fig.3C. The illustrated surface bounds a two dimensional hole in the structure of Fig. 3C.

[0173] In a yet another example, a conduit may comprise a one-dimension hole (e.g. at its entrance or at its exit), and a two-dimension hole bounded by the inside surface of the conduit. See also the two dimensional hole through the structure shown in Fig. 3E, bounded by a surface as shown.

[0174] Fig. 3E shows a perspective view of the structure of Fig. 3C, including the two dimensional hole and the one-dimensional hole. Also shown is the surface that bounds a two dimensional hole in the structure of Fig. 3C.

[0175] Fig. 3F shows a mask having an inflatable bladder as a cushion.

[0176] Figs. 3G and 3H illustrate cross-sections of the mask of Fig. 3F. For example,Fig. 3G shows a first cross-section through the mask of Fig. 3F, and shows the interior surface of the bladder. The interior surface bounds the two dimensional hole in the mask. Fig. 3H shows a second cross-section through the mask of Fig. 3F. The interior surface is also indicated. As illustrated in Figs. 3G and 3H, the interior surface of the cushion of the mask may have a complex three-dimensional shape. The interior surface of the cushion may also change shape during use. For example, as the cushion conforms to a patient’s face, the curvatures of the interior surface may become more or less pronounced.5.3.2 Plenum chamber

[0177] With reference back to Fig. 2, the plenum chamber 3200 has a perimeter that is shaped to be complementary to the surface contour of the face of an average person in the region where a seal will form in use. In use, a marginal edge of the plenum chamber 3200 is positioned in close proximity to an adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend in use about the entire perimeter of the plenum chamber 3200. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material.

[0178] In certain forms of the present technology, the plenum chamber 3200 does not cover the eyes of the patient in use. In other words, the eyes are outside thepressurised volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with therapy.

[0179] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material, e.g. a transparent polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy. The use of a transparent material can aid a clinician to observe how the patient interface is located and functioning.

[0180] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy.

[0181] In some forms, the plenum chamber 3200 is constructed from a rigid material such as polycarbonate. The rigid material may provide support to the seal-forming structure.

[0182] In some forms, the plenum chamber 3200 is constructed from a flexible material (e.g., constructed from a soft, flexible, resilient material like silicone, textile, foam, etc.). For example, in examples then may be formed from a material which has a Young's modulus of 0.4 GPa or lower, for example foam. In some forms of the technology the plenum chamber 3200 may be made from a material having Young's modulus of 0.1 GPa or lower, for example rubber. In other forms of the technology the plenum chamber 3200 may be made from a material having a Young's modulus of 0.5MPa or less, for example between 0.5MPa and 0.3GPa. An example of such a material is silicone.5.3.2.1 Multiple Openings

[0183] As shown in Figs. 5A and 5B, different plenum chambers 3200-1, 3200-2 may be formed as part of a multi-opening cushion 3050-1, 3050-2. In the illustrated examples, the cushions 3050-1, 3050-2 each include three openings, although an alternate cushion may be formed with greater or fewer openings.

[0184] In some forms, the different openings may serve different functions. For example, some openings may be exclusively inlet openings, while other openings may be exclusively outlet openings.

[0185] In other forms, at least one opening may serve two different functions. For example, one opening may operate as both an inlet and an outlet during the same breathing cycle.

[0186] The plurality of openings may allow for a variety of configurations of air delivery to the plenum chamber 3200-1, 3200-2. For example, depending on patient need and / or patient comfort, the patient may use a given cushion 3050-1, 3050-2 in a “tube- up” configuration (e.g., using conduit headgear - described below) or a “tube-down” configuration (e.g., using a single conduit in front of the patient’s face).5.3.2.1.1 Nose and Mouth Mask

[0187] As shown in Fig. 5 A, the plenum chamber 3200-1 includes a pair of plenum chamber inlet ports 3254-1, which may be used to convey gas into and / or out of the plenum chamber 3200- 1. The plenum chamber inlet ports 3254- 1 may be disposed on opposite sides (e.g., left and right sides) of the plenum chamber 3200-1.

[0188] In some forms, the plenum chamber 3200-1 may also include at least one vent opening 3402-1 (see e.g., Fig. 5 A). The vent opening 3402-1 may be disposed in a center of the plenum chamber 3200-1. For example, the vent opening 3402-1 may be disposed between the plenum chamber inlet ports 3254-1.

[0189] In some forms, the plenum chamber 3200-1 may include a pair of grooves 3266- 1. Each groove 3266- 1 may be disposed proximate to one of the plenum chamber inlet ports 3254- 1. Each groove 3266- 1 may form a partially recessed surface.5.3.2.1.2 Nose-only Mask

[0190] The plenum chamber 3200-2 of a nasal only cushion 3050-2 may be similar to the plenum chamber 3200-1 of the mouth and nose cushion 3050-1. Only some similarities and differences between the plenum chambers 3200- 1 , 3200-2 may be described below.

[0191] As shown in Fig. 5B, the plenum chamber 3200-2 includes a pair of plenum chamber inlet ports 3254-2, which may be used to convey gas into and / or out of the plenum chamber 3200-2. The plenum chamber inlet ports 3254-2 may be disposed on opposite sides (e.g., left and right sides) of the plenum chamber 3200-2.

[0192] In some forms, the plenum chamber 3200-2 may also include at least one vent opening 3402-2 (see e.g., Fig. 5B). The vent opening 3402-2 may be disposed in a centerof the plenum chamber 3200-2. For example, the vent opening 3402-2 may be disposed between the plenum chamber inlet ports 3254-2.

[0193] In some forms, the plenum chamber 3200-2 may include a pair of grooves 3266-2. Each groove 3266-2 may be disposed proximate to one of the plenum chamber inlet ports 3254-2. Each groove 3266-2 may form a partially recessed surface.5.3.3 Positioning and stabilising structure

[0194] In one form the positioning and stabilising structure 3300 provides a retention force as a safety margin to overcome the potential effect of disrupting forces on the patient interface 3000, such as from tube drag, or accidental interference with the patient interface.

[0195] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured in a manner consistent with being worn by a patient while sleeping. In one example the positioning and stabilising structure 3300 has a low profile, or cross-sectional thickness, to reduce the perceived or actual bulk of the apparatus. In one example, the positioning and stabilising structure 3300 comprises at least one strap having a rectangular cross-section. In one example the positioning and stabilising structure 3300 comprises at least one flat strap.

[0196] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a supine sleeping position with a back region of the patient’s head on a pillow.

[0197] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a side sleeping position with a side region of the patient’s head on a pillow.

[0198] In one form of the present technology, a positioning and stabilising structure 3300 is provided with a decoupling portion located between an anterior portion of the positioning and stabilising structure 3300, and a posterior portion of the positioning and stabilising structure 3300. The decoupling portion does not resist compression and may be, e.g. a flexible or floppy strap. The decoupling portion is constructed and arranged so that when the patient lies with their head on a pillow, the presence of the decouplingportion prevents a force on the posterior portion from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.

[0199] In one form of the present technology, a positioning and stabilising structure 3300 comprises a strap constructed from a laminate of a fabric patient-contacting layer, a foam inner layer and a fabric outer layer. In one form, the foam is porous to allow moisture, (e.g., sweat), to pass through the strap. In one form, the fabric outer layer comprises loop material to engage with a hook material portion.

[0200] In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap that is extensible, e.g. resiliently extensible. For example the strap may be configured in use to be in tension, and to direct a force to draw a sealforming structure into sealing contact with a portion of a patient’s face. In an example the strap may be configured as a tie.

[0201] In one form of the present technology, the positioning and stabilising structure comprises a first tie, the first tie being constructed and arranged so that in use at least a portion of an inferior edge thereof passes superior to an otobasion superior of the patient’s head and overlays a portion of a parietal bone without overlaying the occipital bone.

[0202] In one form of the present technology suitable for a nasal-only mask or for a full-face mask, the positioning and stabilising structure includes a second tie, the second tie being constructed and arranged so that in use at least a portion of a superior edge thereof passes inferior to an otobasion inferior of the patient’s head and overlays or lies inferior to the occipital bone of the patient’s head.

[0203] In one form of the present technology suitable for a nasal-only mask or for a full-face mask, the positioning and stabilising structure includes a third tie that is constructed and arranged to interconnect the first tie and the second tie to reduce a tendency of the first tie and the second tie to move apart from one another.

[0204] In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap that is bendable and e.g. non-rigid. An advantage of this aspect is that the strap is more comfortable for a patient to lie upon while the patient is sleeping.

[0205] In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap constructed to be breathable to allow moisture vapour to be transmitted through the strap,

[0206] In certain forms of the present technology, a system is provided comprising more than one positioning and stabilising structure 3300, each being configured to provide a retaining force to correspond to a different size and / or shape range. For example the system may comprise one form of positioning and stabilising structure 3300 suitable for a large sized head, but not a small sized head, and another, suitable for a small sized head, but not a large sized head.5.3.3.1 Conduit headgear5.3.3.1.1 Conduit headgear tubes

[0207] In some forms of the present technology, the positioning and stabilising structure 3300 comprises one or more headgear tubes 3350 that deliver pressurised air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient’s airways, for example through the plenum chamber 3200 and seal-forming structure 3100. In the form of the present technology illustrated in Fig. 5J, the positioning and stabilising structure 3300 comprises two tubes 3350 that deliver air to the plenum chamber 3200 from the air circuit 4170. The tubes 3350 are configured to position and stabilise the seal-forming structure 3100 of the patient interface 3000 at the appropriate part of the patient’s face (for example, the nose and / or mouth) in use. This allows the conduit of air circuit 4170 providing the flow of pressurised air to connect to a connection port 3600 of the patient interface in a position other than in front of the patient’s face, for example on top of the patient’s head.

[0208] In the form of the present technology illustrated in Fig. 5J, the positioning and stabilising structure 3300 comprises two tubes 3350, each tube 3350 being positioned in use on a different side of the patient’s head and extending across the respective cheek region, above the respective ear (superior to the otobasion superior on the patient’s head) to the elbow 3610 on top of the head of the patient 1000. This form of technology may be advantageous because, if a patient sleeps with their head on its side and one of the tubes 3350 is compressed to block or partially block the flow of gas along the tube 3350, the other tube 3350 remains open to supply pressurised gas to the patient. In other examplesof the technology, the patient interface 3000 may comprise a different number of tubes, for example one tube, or two or more tubes.

[0209] In one example in which the patient interface has one tube 3350, the single tube 3350 is positioned on one side of the patient’s head in use (e.g. across one cheek region) and a strap forms part of the positioning and stabilising structure 3300 and is positioned on the other side of the patient’s head in use (e.g. across the other region) to assist in securing the patient interface 3000 on the patient’s head. For example, the tube 3350 and the strap may each be under tension in use in order to assist in maintaining the seal-forming structure 3100 in a sealing position.

[0210] In one form, the tube 3350 may be at least partially extensible so that the tube 3350 and the strap may adjust substantially equal lengths when worn by a patient. This may allow for substantially symmetrical adjustments between the tube 3350 and the strap so that the seal-forming structure remains substantially in the middle.

[0211] In the form of the technology shown in Fig. 5J, the two tubes 3350 are fluidly connected at superior ends to each other and to the connection port 3600. In some examples, the two tubes 3350 are integrally formed while in other examples the tubes 3350 are formed separately but are connected in use and may be disconnected, for example for cleaning or storage. Where separate tubes are used, they may be indirectly connected together, for example each may be connected to a T-shaped connector. The T- shaped connector may have two arms / branches each fluidly connectable to a respective one of the tubes 3350. Additionally, the T-shaped connector may have a third arm or opening providing the connection port 3600 for fluid connection to the air circuit 4170 in use. The opening may be an inlet 3332 (see e.g., 5C) for receiving the flow of pressurized air.

[0212] In some forms, the third arm of the T-shaped connector may be substantially perpendicular to each of the first two arms.

[0213] In some forms, the third arm of the T-shaped connector may be obliquely formed with respect to each of the first two arms.

[0214] In some forms, a Y-shaped connector may be used instead of the T-shaped connector. The first two arms may be oblique with respect to one another, and the third arm may be oblique with respect to the first two arms. The angled formation of the firsttwo arms may be similar to the shape of the patient’s head in order to conform to the shape.

[0215] In some forms, at least one of the arms of the T-shaped connector (or Y- shaped connector) may be flexible. This may allow the connector to bend based on the shape of the patient’s head and / or a force in the positioning and stabilising structure 3300.

[0216] In some forms, at least one of the arms of the T-shaped connector (or Y- shaped connector) may be at least partially rigidised. This may assist in maintaining the shape of the connector so that bending of the connector does not close the airflow path.

[0217] The tubes 3350 may be formed from a flexible material, such as an elastomer, e.g. silicone or TPE, and / or from one or more textile and / or foam materials. The tubes 3350 may have a preformed shape and may be able to be bent or moved into another shape upon application of a force but may return to the original preformed shape in the absence of said force. The tubes 3350 may be generally arcuate or curved in a shape approximating the contours of a patient’s head between the top of the head and the nasal or oral region.

[0218] In some examples, the one or more tubes 3350 are crush resistant to resist being blocked if crushed during use, for example if squashed between a patient’s head and pillow, especially if there is only one tube 3350. The tubes 3350 may be formed with a sufficient structural stiffness to resist crushing or may be as described in US Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0219] Each tube 3350 may be configured to receive a flow of air from the connection port 3600 on top of the patient’s head and to deliver the flow of air to the sealforming structure 3100 at the entrance of the patient’s airways. In the example shown in Fig. 5J, each tube 3350 lies in use on a path extending from the plenum chamber 3200 across the patient’s cheek region and superior to the patient’s ear to the elbow 3610. For example, a portion of each tube 3350 proximate the plenum chamber 3200 may overlie a maxilla region of the patient’s head in use. Another portion of each tube 3350 may overlie a region of the patient’s head superior to an otobasion superior of the patient’s head. Each of the tubes 3350 may also lie over the patient’s sphenoid bone and / or temporal bone and either or both of the patient’s frontal bone and parietal bone. Theelbow 3610 may be located in use over the patient’s parietal bone, over the frontal bone and / or over the junction therebetween (e.g. the coronal suture).

[0220] In certain forms of the present technology the patient interface 3000 is configured such that the connection port 3600 can be positioned in a range of positions across the top of the patient’s head so that the patient interface 3000 can be positioned as appropriate for the comfort or fit of an individual patient. In some examples, the headgear tubes 3350 are configured to allow movement of an upper portion of the patient interface 3000 (e.g. a connection port 3600) with respect to a lower portion of the patient interface 3000 (e.g. a plenum chamber 3200). That is, the connection port 3600 may be at least partially decoupled from the plenum chamber 3200. In this way, the seal-forming structure 3100 may form an effective seal with the patient’s face irrespective of the position of the connection port 3600 (at least within a predetermined range of positions) on the patient’s head.

[0221] As described above, in some examples of the present technology the patient interface 3000 comprises a seal-forming structure 3100 in the form of a cradle cushion which lies generally under the nose and seals to an inferior periphery of the nose (e.g. an under-the-nose cushion). The positioning and stabilising structure 3300, including the tubes 3350 may be structured and arranged to pull the seal-forming structure 3100 into the patient’s face under the nose with a sealing force in a posterior and superior direction (e.g. a posterosuperior direction). A sealing force with a posterosuperior direction may cause the seal-forming structure 3100 to form a good seal to both the inferior periphery of the patient’s nose and anterior-facing surfaces of the patient’s face, for example on either side of the patient’s nose and the patient’s lip superior.5.3.3.1.2 Extendable and non-extendable tube portions

[0222] In some examples of the present technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tubes 3350 may comprise one or more extendable tube sections, for example formed by an extendable concertina structure. In some forms, the patient interface 3000 may comprise a positioning and stabilising structure 3300 including at least one gas delivery tube comprising a tube wall having an extendable concertina structure. The patient interface 3000 shown in Fig. 5Jcomprises tubes 3350, the superior portions of which comprise extendable tube sections each in the form of an extendable concertina structure 3362.

[0223] In some forms, the extendable concertina structure 3328 may be formed as a series of ridges and grooves on the surface of the tubes 3350. The concertina structure 3328 may be biased toward a retracted position, and may move to an expanded position when the patient dons the positioning and stabilising structure 3300. Because portions of the tubes 3350 may be substantially inextensible (e.g., non-extendable tube sections 3363), the concertina structures 3328 permit the positioning and stabilising structure 3300 to stretch in order to fit different sized heads. This may allow a single sized tube 3350 to be used with multiple sized heads. For example, the positioning and stabilising structure 3300 may be “one-size-fits-all” as a result of the concertina structure 3328. Alternatively, the tubes 3350 may be manufactured in multiple sizes (e.g., small, medium, large). The patient may select a length that most closely conforms to their head, and the concertina structures 3328 may make small adjustments in order to tailor the fit to the individual patient.

[0224] In some forms, the inlet 3332 may be disposed in the middle of the conduit 6320. For example, the tubes 3350 may be symmetric about the inlet 3332 through at least one axis.

[0225] The cross-sectional shape of the non-extendable tube sections 3363 of the tubes 3350 may be circular, elliptical, oval, D-shaped or a rounded rectangle, for example as described in US Patent No. 6,044,844. A cross-sectional shape that presents a flattened surface of tube on the side that faces and contacts the patient’s face or other part of the head may be more comfortable to wear than, for example a tube with a circular crosssection.

[0226] In some examples of the present technology, the non-extendable tube sections 3363 connects to the plenum chamber 3200 from a low angle. The headgear tubes 3350 may extend inferiorly down the sides of the patient’s head and then curve anteriorly and medially to connect to the plenum chamber 3200 in front of the patient’s face. The tubes 3350, before connecting to the plenum chamber 3200, may extend to a location at the same vertical position as (or, in some examples, inferior to) the connection with the plenum chamber 3200. That is, the tubes 3350 may project in an at least partially superiordirection before connecting with the plenum chamber 3200. A portion of the tubes 3350 may be located inferior to the plenum chamber 3200 and / or the seal-forming structure 3100. The tubes 3350 may contact the patient’s face below the patient’s cheekbones, which may be more comfortable than contact on the patient’s cheekbones and may avoid excessively obscuring the patient’s peripheral vision.5.3.3.1.3 Conduit headgear connection port

[0227] In certain forms of the present technology, the patient interface 3000 may comprise a connection port 3600 located proximal to a superior, lateral or posterior portion of a patient’s head. For example, in the form of the present technology illustrated in Fig 5 J, the connection port 3600 is located on top of the patient’s head (e.g. at a superior location with respect to the patient’s head). In this example the patient interface 3000 comprises an elbow 3610 forming the connection port 3600. The elbow 3610 may be configured to fluidly connect with a conduit of an air circuit 4170. The elbow 3610 may be configured to swivel with respect to the positioning and stabilising structure 3300 to at least partially decouple the conduit from the positioning and stabilising structure 3300. In some examples the elbow 3610 may be configured to swivel by rotation about a substantially vertical axis and, in some particular examples, by rotation about two or more axes. In some examples the elbow may comprise or be connected to the tubes 3350 by a ball-and-socket joint. The connection port 3600 may be located in the sagittal plane of the patient’s head in use.

[0228] Patient interfaces having a connection port that is not positioned anterior to the patient’s face may be advantageous as some patients may find a conduit that connects to a patient interface anterior to their face to be unsightly and / or obtrusive. For example, a conduit connecting to a patient interface anterior to the patient’s face may be prone to interference with bedclothes or bed linen, particularly if the conduit extends inferiorly from the patient interface in use. Forms of the present technology comprising a patient interface having a connection port positioned superiorly to the patient’s head in use may make it easier or more comfortable for a patient to lie or sleep in one or more of the following positions: a side-sleeping position, a supine position (e.g. on their back, facing generally upwards) or in a prone position (e.g. on their front, facing generally downwards). Moreover, connecting a conduit to an anterior portion of a patient interfacemay exacerbate a problem known as tube drag in which the conduit exerts an undesired force upon the patient interface during movement of the patient’s head or the conduit, thereby causing dislodgement away from the face. Tube drag may be less of a problem when force is received at a superior location of the patient’s head than anterior to the patient’s face proximate to the seal-forming structure (where tube drag forces may be more likely to disrupt the seal).5.3.3.1.4 Headgear Tube Fluid Connections

[0229] The two tubes 3350 are fluidly connected at their inferior ends to the plenum chamber 3200. In certain forms of the technology, the connection between the tubes 3350 and the plenum chamber 3200 is achieved by connection of two rigid connectors. The tubes 3350 and plenum chamber 3200 may be configured to enable the patient to easily connect the two components together in a reliable manner. The tubes 3350 and plenum chamber 3200 may be configured to provide tactile and / or audible feedback in the form of a ‘re-assuring click’ or a similar sound, so that the patient may easily know that each tube 3350 has been correctly connected to the plenum chamber 3200. In one form, the tubes 3350 are formed from a silicone or textile material and the inferior end of each of the silicone tubes 3350 is overmolded to a rigid connector made, for example, from polypropylene, polycarbonate, nylon or the like. The rigid connector on each tube 3350 may comprise a female mating feature configured to connect with a male mating feature on the plenum chamber 3200. Alternatively, the rigid connector on each tube 3350 may comprise a male mating feature configured to connect to a female mating feature on the plenum chamber 3200. In other examples the tubes 3350 may each comprise a male or female connector formed from a flexible material, such as silicone or TPE, for example the same material from which the tubes 3350 are formed.

[0230] In other examples a compression seal is 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 may be configured to be squeezed to reduce its diameter so that it can be compressed into a port in the plenum chamber 3200 and the inherent resilience of the silicone pushes the tube 3350 outwards to seal the tube 3350 in the port in an airtight manner. Alternatively, in a hard-to-hard type engagement between the tube 3350 and the plenum chamber 3200, each tube 3350 and / or plenum chamber 3200 maycomprise a pressure activated seal, for example a peripheral sealing flange. When pressurised gas is supplied through the tubes 3350 the sealing flange may be urged against the join between the tubes and a circumferential surface around a port or connector of the plenum chamber 3200 to form or enhance a seal between the tube 3350 and plenum chamber 3200.5.3.3.2 Headgear straps

[0231] In some forms, the positioning and stabilising structure 3300 may include headgear 3302 with at least one strap which may be worn by the patient in order to assist in properly orienting the seal-forming structure 3100 against the patient’s face (e.g., in order to limit or prevent leaks).

[0232] As described above, some forms of the headgear 3302 may be constructed from a textile material, which may be comfortable against the patient’s skin. The textile may be flexible in order to conform to a variety of facial contours. Although the textile may include rigidisers along a selected length, which may limit bending, flexing, and / or stretching of the headgear 3302.

[0233] In certain forms, the headgear 3302 may be at least partially extensible. For example, the headgear 3302 may include elastic, or a similar extensible material. For example, the entire headgear 3302 may be extensible or selected portions may be extensible (or more extensible than surrounding portions). This may allow the headgear 3302 to stretch while under tension, which may assist in providing a sealing force for the seal-forming structure 3100.

[0234] Two forms of the headgear, four-point headgear 3302-1 and two-point headgear 3302-2, are discussed in more detail below as illustrative examples.5.3.3.2.1 Four-point connection

[0235] As shown in Fig. 5E, some forms of the headgear 3302-1 may be a four-point connection headgear. This means that the headgear 3302-1 may connect to four separate places on the plenum chamber 3200, on a frame connected to the plenum chamber 3200, and / or on arms connected to the plenum chamber 3200. The headgear 3302-1 may include four different straps providing a tensile force to help maintain the seal-forming structure 3100 in a sealing position.

[0236] In some forms, the headgear 3302-1 may include inferior straps 3304-1, which may connect to an inferior portion of the cushion 3050-1. The inferior straps 3304- 1 may extend along the patient’s cheek toward a posterior region of the patient’s head.For example, the inferior straps 3304-1 may overlay the masseter muscle on either side of the patient’s face. The inferior straps 3304-1 may therefore contact the patient’s head below the patient’s ears. The inferior straps 3304-1 may meet at the posterior of the patient’s head, and may overlay the occipital bone and / or the trapezius muscle.

[0237] The headgear 3302-1 may also include superior straps 3305-1, which may overlay the temporal bones, parietal bone, and / or occipital bone. The superior straps 3305-1 may also connect to the tubes 3350 (e.g., by interfacing with the tabs 3320).

[0238] A rear strap 3307-1 may extend between the superior straps 3305-1 and between the inferior straps 3304-1. The inferior and superior straps 3304-1, 3305-1 on a given side (e.g., left or right) may also be connected to the rear strap 3307-1 adjacent to one another. The height of the rear strap 3307-1 may therefore be approximately the combined height of the inferior and superior strap 3304-1, 3305-1. The rear strap 3307-1 may overlay the occipital bone and / or the pariental bone in use. This may allow the rear strap 3307-1 to assist in anchoring the headgear 3302-1 to the patient’s head.

[0239] In the illustrated example, the headgear 3302-1 may be formed with a substantially X-shape. The inferior and superior straps 3304-1, 3305-1 may be connected to a rear strap 3307-1 using stitching, ultrasonic welding, or any similar process.

[0240] In some forms, the inferior straps 3304-1 are connected to a magnetic member 3306-1. For example, each inferior straps 3304-1 may be threaded through a magnetic member 3306-1, so that a length of each inferior strap 3304-1 may be adjusted. The magnetic members 3306-1 may removably connect to the magnets 3370-1 (described below), so that the inferior straps 3304-1 may be disconnected from the plenum chamber 3200, but the length of the inferior straps 3304-1 may not be affected.

[0241] In some forms, the superior straps 3305-1 may be connected directly to the tabs 3320 of the tubes 3350. The superior straps 3305-1 may be threaded through the tabs 3320 in order to adjust the length and control the tensile force of each superior strap 3305-1.

[0242] In some forms, the headgear 3302-1 may be used only with the nose and mouth cushion 3050-1 (e.g., because the nose-only cushion 3050-1 does not have four connection points). However, the headgear 3302-1 may be used interchangeably with the tubes 3350 and the rigidiser arms 3340.5.3.3.2.2 Two-point connection

[0243] As shown in Fig. 5F, some forms of the headgear 3302-2 may be a two-point connection headgear. This means that the headgear 3302-2 may connect to two separate places.

[0244] In some forms, the headgear 3302-2 may be formed from a continuous piece of material. In other words, the headgear 3302-2 may not be formed from multiple straps connected (e.g., stitched) together. This may be comfortable for a patient as they will not be in contact with any seams or joints connecting different straps. In other forms, the headgear 3302-2 may be formed from multiple straps (e.g., two superior straps, a rear strap, etc.) that are connected together (e.g., with stitching, ultra-sonic welding, etc.).

[0245] In certain forms of the present technology, the positioning and stabilising structure 3300 comprises at least one headgear strap acting in addition to the tubes 3350 to position and stabilise the seal-forming structure 3100 at the entrance to the patient’s airways. As shown in Fig. 5F, the patient interface 3000 comprises a rear strap 3307-2 forming part of the positioning and stabilising structure 3300. The rear strap 3307-2 may be known as a back strap or a rear headgear strap, for example. The rear strap 3307-2 may overlay the temporal bones, parietal bone, and / or occipital bone. In other examples of the present technology, one or more further straps may be provided. For example, patient interface 3000 according to examples of the present technology having a nose- and-mouth cushion may have a second, lower, strap configured to he against the patient’s head proximate the patient’s neck and / or against posterior surfaces of the patient’s neck.

[0246] As shown in Fig. 5F, some forms of the headgear 3302-2 may be at least partially bifurcated. For example, a rear strap 3307-2 of the headgear 3302-2 (e.g., configured to contact the posterior portion of the patient’s head) may be wider than the surrounding portions of the headgear 3302-2. An intermediate section 3308-2 of the rear strap 3307-2 may include a slit 3309-2. A superior section of the rear strap 3307-2 may therefore be movable relative to the inferior section as a result of the slit 3309-2. Thismay allow the patient to have a larger strap coverage on the posterior region of their head, which may assist in better anchoring the headgear 3302-2 to the patient’s head since there is no inferior strap (e.g., 3304-1).

[0247] In some forms, the headgear 3302-2 may be used only with the nasal cushion 3050-2 (e.g., because the nose and mouth cushion 3050-1 does not have four connection points). However, the headgear 3302-2 may be used interchangeably with the tubes 3350 and the rigidiser arms 3340.5.3.3.3 Rigidiser Arm

[0248] As shown in Fig. 5D, a rigidiser arm 3340 may be an elongated, rigid member that assists in maintaining the cushion (e.g., the nose and mouth cushion 3050-1 or the nasal cushion 3050-2) in an operating position. The rigidiser arm 3340 may contact a side of the patient’s head and provide a force to limit slipping of the seal-forming structure 3100 from the patient’s nose and / or mouth.

[0249] In some forms, the rigidiser arm 3340 is constructed from a rigid material (e.g., plastic). The rigid material may not permit the rigidiser arm 3340 to stretch.

[0250] In some forms, the rigidiser arm 3340 may be flexible along at least one direction. For example, the rigidiser arm 3340 may be flexible about its width and may be inflexible along its length. In other words, the rigidiser arm 3340 may be bendable about an axis along the width of the rigidiser arm 3340, but may be unable to bend about an axis perpendicular to the rigidiser arm 3340. This may allow an individual patient to adjust the rigidiser arm 3340 in order to better fit their individual head.

[0251] In certain forms, the rigidiser arm 3340 may remain in the new position after being bent. This may allow a patient adjust the shape of the rigidiser arm 3340 for their specific head and then the rigidiser arm 3340 will keep the desired shape while in use in order to promote patient comfort.

[0252] In some forms, a first end 3342 of the rigidiser arm 3340 may be a free end and a second end 3344 (e.g., opposite of the first end 3342) of the rigidiser arm 3340 may be fixed. The first end 3342 may be curved in order to minimize sharp edges that could cause patient discomfort. The first end 3342 may also overlay the patient’s head proximate to the temporal bone, in use. The second end 3344 may be fixed to an arm connection structure 3504.

[0253] In some forms, the arm connection structure 3504 may be similar to the conduit connection structure 3500. For example, the arm connection structure 3504 and the conduit connection structure 3500 may have substantially the same shape. This may allow either the conduit connection structure 3500 or the arm connection structure 3504 to fit into the groove (e.g., 3266-1 or 3266-2) and connect to the plenum chamber inlet port 3254. The arm connection structure 3504 may connect to the nose and mouth cushion 3050-1 or the nose-only cushion 3050-2 in substantially the same way as the conduit connection structure 3500 (e.g., via a snap fit, press fit, friction fit, etc.).

[0254] In some forms, the arm connection structure 3504 may act as a plug for the plenum chamber inlet port 3254 (e.g., either 3254-1 and / or 3254-2). Unlike the tubes 3350, the rigidiser arm 3340 does not convey pressurized air to the plenum chamber 3200. The rigidiser arm 3340 may be used with a “tube down” configuration, where a hose is connected to the vent opening 3402 (e.g., either 3402-1 and / or 3402-2), and conveys air into the plenum chamber 3200 through the vent opening 3402. In this example, air does not need to travel into or out of the plenum chamber inlet ports 3254. Thus, the arm connection structure 3504 may form a seal with the plenum chamber inlet port 3254 in order to limit airflow into or out of the plenum chamber 3200.5.3.4 Vent

[0255] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the washout of exhaled gases, e.g. carbon dioxide.

[0256] In certain forms the vent 3400 is configured to allow a continuous vent flow from an interior of the plenum chamber 3200 to ambient whilst the pressure within the plenum chamber is positive with respect to ambient. The vent 3400 is configured such that the vent flow rate has a magnitude sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining the therapeutic pressure in the plenum chamber in use.

[0257] One form of vent 3400 in accordance with the present technology comprises a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0258] The vent 3400 may be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure, e.g., a swivel.

[0259] As shown in Fig. 5N, a vent 3450 may be used with the patient interface 3000. The vent 3450 may have a substantially similar shape to the vent opening 3402-1 (e.g., a substantially circular shape).

[0260] The vent 3450 may be used with either the mouth and nose plenum chamber 3200-1 (e.g., illustrated in Figs. 5A) or the nose-only plenum chamber 3200-2 (e.g., illustrated in Figs. 5B).

[0261] With continued reference to Fig. 5 A, the vent 3450 may include a vent housing 3404, which may be configured to engage with the vent opening 3402. The vent housing 3404 may be constructed from a rigid material or a semi-rigid material. For example, the vent housing 3404 may be constructed from plastic, metal, or any similar material. The vent housing 3404 may add rigidity to the patient interface 3000 (e.g., to limit unwanted bending that may affect the position of the seal-forming structure 3100 on the patient’s face).

[0262] The vent housing 3404 may include an anterior surface 3408, a posterior surface 3412, and a groove 3416. The anterior surface 3408 faces away from the patient’s face in use, and may be positioned outside the pressurized volume of the plenum chamber 3200. The posterior surface 3412 is disposed opposite to the anterior surface 3408. In use, the posterior surface 3412 may face the patient and may be disposed within the pressurized volume of the plenum chamber 3200. The groove 3416 may be formed between the anterior and posterior surfaces 3408, 3412. A portion of the plenum chamber 3200 may be received within the groove 3416 in order to retain the vent 3400 in position.

[0263] In some forms, a diffuser 3448 may be used with the vent housing 3404. The diffuser 3448 may assist with limiting the decibel output from any of the patient interface 3000 (or any other patient interface). Specifically, the diffuser 3448 may assist in limiting the decibel level associated with air output from the patient interface 3000 (e.g., exhaled air), although the diffuser 3448 may limit the decibel level of at any point in the patient interface.

[0264] In certain forms, the diffuser 3448 may diffuse, and therefore slow, the exhaust gas exiting the plenum chamber 3200 and passing through the vent housing 3404. The diffuser 3448 may assist in avoiding jetting and associated discomfort to the patient and / or bed partner (e.g., noise caused by jetting against a pillow, sheets, bedclothes, etc.).

[0265] In some forms, the diffuser may include an anterior surface 3456 that faces away from the patient in use. An outer diameter of the anterior surface 3456 may be less than an inner diameter of the vent housing 3404 proximate to the anterior surface 3408. This may form a gap 3464 through which air may travel.5.3.5 Decoupling structure(s)

[0266] In one form the patient interface 3000 includes at least one decoupling structure, for example, a swivel or a ball and socket.5.3.6 Modularity

[0267] As described above, the cushion, headgear, and sleeves may come in different styles, which may correspond to different uses (e.g., mouth breathing, nasal breathing, etc.). A patient or clinician may select certain combinations of cushions, headgear, and sleeves in order to optimize the effectiveness of the therapy and / or the individual patient’s comfort. An example of this sort of modular design is described in PCT / SG2022 / 050777 filed 28 October 2022, incorporated herein by reference in its entirety.

[0268] In some forms, the different styles of cushions, headgear, and sleeves may be used interchangeably with one another in order to form different combinations of patient interfaces. This may be beneficial from a manufacturing prospective because wider variety of patient interfaces may be created using fewer parts. Additionally or alternatively, the various combinations may allow a patient to change styles of patient interface without changing the every component.

[0269] Air may be delivered to the patient in one of two main ways. In one example, the patient may receive the flow of pressurized air through headgear tubes 3350 (see e.g., Fig. 5C, 5J). This may be referred to as a “tube up” configuration and may position a connection port at the top of the patient’s head. In other example, the patient may receive the flow of pressurized air through a conduit connected to the plenum chamber 3200. This may be referred to a “tube down” configuration where the airflow conduit is positioned in front of the patient’s face. Different patients may be more comfortable with one style of air delivery over the other (e.g., because of the patient’s sleep style).Therefore, it may be beneficial to allow a single style of patient interface to be used in either the “tube up” or “tube down” configuration.

[0270] The patient interface may be part of a modular assembly with a variety of interchangeable components that may be swapped out by a patient and / or clinician for one or more components for a different style. The following description describes the various combinations that may be created by assembling the different components together.5.3.6.1 Sleeve

[0271] In some forms, to allow for modularity, a sleeve may be used with the tubes 3350 and / or the rigidiser arms 3340. The sleeve may at least partially surround the tubes 3350 and / or the rigidiser arms 3340. As shown in Figs. 5G to 51, different shapes of sleeves may be used, which may correspond to different types of positioning and stabilising structures 3300. In some forms, the configuration of the sleeve may be customized to fit a particular user’s face. For instance, the sleeves may be configured in a relatively more posterior region of the patient’s head.

[0272] In some forms, the sleeve may be constructed from a comfortable material. For example, the sleeve may be constructed from a textile material, a foam material, or a combination of the two. The comfortable material may contact the patient in use, and may feel soft against the patient’s skin in order to improve patient compliance.

[0273] The material may also be flexible in order to assist in donning or doffing the sleeve from the tube 3350 or the rigidiser arms 3340. For example, the material may allow the sleeve to bend in order to conform to the shape of the tubes 3350 or conduit headgear or the rigidiser arms 3340, which may change depending on the shape of an individual patient’s head.

[0274] In some forms, the sleeve may also be at least partially elastic (e.g., the material may allow the sleeve to stretch). The elastic material may help the sleeve stretch in order to fit around the tubes 3350 or the rigidiser arms 3340. The elastic material may then return to an initial position that is snug against the tubes 3350 or the rigidiser arms 3340 in order to limit the sleeve from sliding while in use.

[0275] As described in more detail below, some forms of the sleeves may be specific to a rigidising element (e.g., tubes 3350 and / or rigidiser arms 3340). However, the sleeves may assist the rigidising elements in connecting interchangeably with the versionor styles of cushions (e.g., the mouth and nose cushion 3050-1, the nose-only cushion 3050-2, etc.).5.3.6.2 Conduit Sleeve

[0276] As shown in Fig. 5G, one example of a sleeve is a conduit sleeve 3351, which may be usable with the tubes 3350 described above.

[0277] As shown in Fig. 5G, the conduit sleeve 3351 may include a curved shape that may be similar to the shape of the tubes 3350 shown in Fig. 5C. The flexible material used to construct the conduit sleeve 3351 may allow the conduit sleeve 3351 to further curve in order to correspond to the shape of the tubes 3350 (e.g., when worn by the patient).

[0278] In some forms, the conduit sleeve 3351 may include a first or superior opening 3352. The superior opening 3352 may be disposed at one end of the conduit sleeve 3351. The superior opening 3352 may be an opening to a passage that extends along at least a portion of the conduit sleeve 3351.

[0279] As shown in Fig. 5G, some forms of the conduit sleeve 3351 may also include an inferior extension 3354. The inferior extension 3354 may be positioned on an opposite end of the conduit sleeve 3351 from the superior opening 3352. The conduit sleeve 3351 may be customized to fit a particular user’s face. For instance, the inferior extension 3354 of the conduit sleeve 3351 may be configured in a relatively more posterior region or anterior region of the patient’s head.

[0280] Some forms of the inferior extension 3354 may include a rigid or semi-rigid piece (e.g., within the conduit sleeve 3351). The rigid or semi-rigid piece may be constructed from a plastic material, or a similar material. Alternatively, the inferior extension 3354 may be stiffened using a manufacturing process (e.g., stitching rigidised thread, flat knitting, using thicker material).

[0281] As shown in Fig. 5G, some forms of the inferior extension 3354 may include a connection member 3356. In the illustrated example, the connection member 3356 may be a magnet, although in other examples, the connection member 3356 may be a different type of connector (e.g., a mechanical fastener, an adhesive, hook and loop material, etc.). The connection member 3356 may also be positioned at an end of the inferior extension3354, although the connection member 3356 could alternatively be positioned anywhere along the inferior extension 3354.

[0282] In some forms, the connection member 3356 (e.g., a magnet) may be removably connected to the magnets 3370-1 of the headgear 3302-1. For example, when the conduit sleeves 3351 are connected to the tubes 3350 (see e.g., Fig. 5J), the magnets 3370-1 connected to the inferior straps 3304-1 may be removably connected to the connection member 3356 in order to provide the tensile force.5.3.6.2.1 F our-point arm sleeve

[0283] As shown in Fig. 5H, another example of a sleeve is a four-point arm sleeve 3380, which may be usable with the rigidiser arms 3340 described above.

[0284] As shown in Fig. 5H, the four-point arm sleeve 3380 may include a curved shape that may be similar to the shape of the rigidiser arm 3340 shown in Fig. 5D. The flexible material used to construct the four-point arm sleeve 3380 may allow the four- point arm sleeve 3380 to further curve in order to correspond to the shape of the rigidiser arm 3340 (e.g., when worn by the patient and / or went bent by the patient).

[0285] As shown in Fig. 5H, some forms of the four-point arm sleeve 3380 may include an inferior extension 3384. The inferior extension 3384 may be positioned at an end of the four-point arm sleeve 3380.

[0286] In the illustrated example, the shape and / or structure of the inferior extension 3384 is substantially the same as the shape of the inferior extension 3354. For example, the inferior extension 3384 may be more rigid as compared to the rest of the four-point arm sleeve 3380 (e.g., as a result of rigidising thread or rigid material).

[0287] As shown in Fig. 5H, some forms of the inferior extension 3384 may include a connection member 3386. In the illustrated example, the connection member 3386 may be a magnet, although in other examples, the connection member 3386 may be a different type of connector (e.g., a mechanical fastener, an adhesive, hook and loop material, etc.). The connection member 3386 may also be positioned at an end of the inferior extension 3384, although the connection member 3386 could alternatively be positioned anywhere along the inferior extension 3384.

[0288] In some forms, the connection member 3386 (e.g., a magnet) may be removably connected to the magnets 3370-1 of the headgear 3302-1. For example, whenthe four-point arm sleeves 3380 are connected to the rigidiser arm 3340 (see e.g., Fig. 5K), the magnets 3370-1 connected to the inferior straps 3304-1 may be removably connected to the connection member 3386 in order to provide the tensile force.

[0289] As shown in Fig. 5H, the four-point arm sleeve 3380 may include a pair of tabs 3394, which may be similar to the tab 3320 on the tubes 3350. When the four-point arm sleeve 3380 is worn by the patient, the tabs 3394 may be positioned in substantially the same place on the patient’s head as where the tabs 3320 are positioned when the patient wears the tubes 3350.5.3.6.2.2 Two-point arm sleeve

[0290] As shown in Fig. 51, yet another example of a sleeve is a two-point arm sleeve 3380-1, which may be usable with the rigidiser arms 3340 described above.

[0291] In some forms, the two-point arm sleeve 3380-1 may be similar to the four- point arm sleeve 3380 described above. Only some similarities and differences may be described below.

[0292] As shown in Fig. 51, the two-point arm sleeve 3380-1 may include an inferior opening 3388-1 that is positioned at an end of the two-point arm sleeve 3380-1. The inferior opening 3388-1 may form an opening to a passageway through the two-point arm sleeve 3380-1. In the illustrated example, the inferior opening 3388-1 may open into a surface of the conduit sleeve 3380-1.

[0293] As shown in Fig. 51, the two-point arm sleeve 3380-1 may include a pair of tabs 3394-1, which may be similar to the tab 3320 on the tubes 3350. When the two-point arm sleeve 3380-1 is worn by the patient, the tabs 3394-1 may be positioned in substantially the same place on the patient’s head as where the tabs 3320 are positioned when the patient wears the tubes 3350.5.3.6.3 Assembled Patient Interfaces

[0294] As illustrated in Figs. 5J to 5M, the various elements described above may be combined into four different patient interfaces. The different patient interfaces may allow patients to use different styles based on their individual comfort. The modularity of the different elements (e.g., the ability to be used in multiple styles of patient interfaces) may simplify manufacturing and / or may allow a patient to more easily switch between styles of patient interfaces.5.3.6.3.1 Nose and Mouth Mask Tube Up Configuration

[0295] As illustrated in Fig. 5 J, the patient may wear the cushion 3050-1 in a tube-up configuration with the tubes 3350 and the four-point headgear 3302-1. This assembly may form a tube up nose and mouth patient interface 3000- 1.

[0296] In some forms, a conduit sleeve may be used with the tubes 3350 in order to enable a patient to experience the “tube up” air delivery style with the mouth and nose cushion 3050-1. As is described below, the conduit sleeve provides additional connection locations for connecting the four-point headgear 3302-1. However, other forms of connectors aside from or in addition to the conduit sleeve may be used.

[0297] In the illustrated example, the conduit sleeves may be connected to the tubes 3350 of the positioning and stabilising structure 3300. The tubes 3350 (via the conduit connection structure 3500), may be used to connect the tubes 3350 to the cushion 3050-1. The conduit sleeves provide the magnets in order to connect to the magnets 3370-1 (see e.g., Fig. 5E) of the four-point headgear 3302-1. Alternatively, a different connection form may be used.

[0298] As illustrated in Fig. 5J, the four-point headgear 3302-1 may connect in four separate locations in order to provide a tensile force that maintains the cushion 3050- 1 in a sealing position on the patient’s head.

[0299] For example, the inferior straps 3304-1 (e.g., via the magnetic members 3306-1) may removably connect to the magnets of the conduit sleeves. In use, each inferior strap 3304-1 may contact the patient’s cheek (e.g., overlaying the masseter muscle). The inferior straps 3304-1 may also extend below the patient’s ears.5.3.6.3.2 Nose and Mouth Mask Tube Down Configuration

[0300] As illustrated in Fig. 5K, the patient may wear the cushion 3050-1 in a tubedown configuration with the rigidiser arms 3340 and the four-point headgear 3302-1. This assembly may form a tube down nose and mouth patient interface 3000-2.

[0301] In some forms, a conduit sleeve may be used with the rigidiser arms 3340 in order to enable a patient to experience the “tube down” air delivery style with the mouth and nose cushion 3050-1. As is described below, the conduit sleeve provides additional connection locations for connecting the four-point headgear 3302-1. However, other forms of connectors aside from or in addition to the conduit sleeve may be used.

[0302] In the illustrated example, the conduit sleeves may be connected to the rigidiser arms 3340 of the positioning and stabilising structure 3300. The rigidiser arms 3340 (via the conduit connection structure 3504), may be used to connect the rigidiser arms 3340 to the cushion 3050-1. The conduit sleeves provide the magnets in order to connect to the magnets 3370-1 (see e.g., Fig. 5E) of the four-point headgear 3302-1. Alternatively, a different connection form may be used.

[0303] As illustrated in Fig. 5K, the four-point headgear 3302-1 may connect in four separate locations in order to provide a tensile force that maintains the cushion 3050- 1 in a sealing position on the patient’s head.

[0304] For example, the inferior straps 3304-1 (e.g., via the magnetic members 3306-1) may removably connect to the magnets of the conduit sleeves. In use, each inferior strap 3304-1 may contact the patient’s cheek (e.g., overlaying the masseter muscle). The inferior straps 3304-1 may also extend below the patient’s ears.5.3.6.3.3 Nose Mask Tube Up Configuration

[0305] As illustrated in Fig. 5L, the patient may wear the cushion 3050-2 in a tube- up configuration with the tubes 3350 and the two-point headgear 3302-2. This assembly may form a tube up nose only patient interface 3000-3

[0306] A conduit sleeve may be used with the tubes 3350, and may provide additional comfort to the patient. The sleeve may not add additional connection points to connect the positioning and stabilising structure 3300 on the cushion 3050-2. In the illustrated example, the tubes 3350 of the positioning and stabilising structure 3300 may be connected directly to the cushion 3050-2.

[0307] As illustrated in Fig. 5L, the two-point headgear 3302-2 may connect to the tabs 3320 on the tubes 3350 in order to provide a tensile force that maintains the cushion 3050-2 in a sealing position on the patient’s head.5.3.6.3.4 Nose Mask Tube Down Configuration

[0308] As illustrated in Fig. 5M, the patient may wear the cushion 3050-2 in a tube- up configuration with the rigidiser arms 3340 and the two-point headgear 3302-2. This assembly may form a tube down nose only patient interface 3000-4.

[0309] A conduit sleeve may be used with the rigidiser arms 3340, and may provide additional comfort to the patient. The sleeve may not add additional connection points toconnect the positioning and stabilising structure 3300 on the cushion 3050-2. In the illustrated example, the rigidiser arms 3340 of the positioning and stabilising structure 3300 may be connected directly to the cushion 3050-2.

[0310] As illustrated in Fig. 5M, the two-point headgear 3302-2 may connect to the tabs 3320 on the sleeve in order to provide a tensile force that maintains the cushion 3050-2 in a sealing position on the patient’s head.5.3.6.3.5 Modularity of Elements

[0311] Fig. 5P illustrates how the different elements can be combined in order to form the four different patient interfaces described above. As illustrated, the different components may be reused for different styles of patient interfaces. This may allow for easier manufacturing and assembly, because a large number of the same components may be produced and used in a variety of styles. The only components not used in multiple styles may be the sleeves. However, the sleeves may be easier to manufacture. Fig. 50 shows a portion of air circuit 4170 that may interface with the patient interface, while Fig. 5N shows a vent housing 3404 that may interchangeably replace the air circuit shown in Fig. 50, depending on the style of the patient interface.5.4 RPT DEVICE

[0312] As shown in Figs. 4A-4C, an RPT device 4000 in accordance with one aspect of the present technology comprises mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300, such as any of the methods, in whole or in part, described herein. The RPT device 4000 may be configured to generate a flow of air for delivery to a patient’s airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.5.4.1 Air filter(s)

[0313] An RPT device in accordance with one form of the present technology may include an air filter 4110, or a plurality of air filters 4110.

[0314] In one form illustrated in Fig. 4A, an inlet air filter 4112 is located at the beginning of the pneumatic path upstream of a pressure generator 4140.

[0315] In one form illustrated in Fig. 4A, an outlet air filter 4114, for example an antibacterial filter, is located between an outlet of the pneumatic block 4020 and a patient interface 3000 or 3800.5.4.2 Muffler(s)

[0316] An RPT device in accordance with one form of the present technology may include a muffler 4120, or a plurality of mufflers 4120.

[0317] In one form of the present technology (see e.g., Fig. 4A), an inlet muffler 4122 is located in the pneumatic path upstream of a pressure generator 4140.

[0318] In one form of the present technology, an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and a patient interface 3000 or 3800.

[0319] 5.4.3 Pressure generator

[0320] In one form of the present technology, a pressure generator 4140 for producing a flow, or a supply, of air at positive pressure is a controllable blower 4142.

[0321] The pressure generator 4140 may be under the control of the therapy device controller 4240.

[0322] In other forms, a pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (e.g. compressed air reservoir), or a bellows.5.4.4 Transduce r(s)

[0323] Transducers may be internal of the RPT device, or external of the RPT device. External transducers may be located for example on or form part of the air circuit, e.g., the patient interface. External transducers may be in the form of non-contact sensors such as a Doppler radar movement sensor that transmit or transfer data to the RPT device.

[0324] In one form of the present technology (see e.g., Fig. 4A), one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate signals representing properties of the flow of air such as a flow rate, a pressure or a temperature at that point in the pneumatic path.

[0325] In one form of the present technology, one or more transducers 4270 may be located proximate to the patient interface 3000 or 3800.

[0326] In one form, a signal from a transducer 4270 may be filtered, such as by low- pass, high-pass or band-pass filtering.5.4.5 RPT Sensors5.4.5.1 Flow Rate Sensor

[0327] A flow rate sensor 4274 in accordance with the present technology may be based on a differential pressure transducer, for example, an SDP600 Series differential pressure transducer from SENSIRION.

[0328] In one form, a signal generated by the flow rate sensor 4274 and representing a flow rate is received by the central controller 4230.5.4.5.2 Pressure sensor

[0329] A pressure sensor 4272 in accordance with the present technology is located in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. An alternative suitable pressure sensor is a transducer from the NPA Series from GENERAL ELECTRIC.

[0330] In one form, a signal generated by the pressure sensor 4272 and representing a pressure is received by the central controller 4230.5.4.6 Motor speed transducer

[0331] In one form of the present technology a motor speed transducer 4276 is used to determine a rotational velocity of a motor 4144 and / or the blower 4142. A motor speed signal from the motor speed transducer 4276 may be provided to the therapy device controller 4240. The motor speed transducer 4276 may, for example, be a speed sensor, such as a Hall effect sensor.5.4.7 Anti-spill back valve

[0332] As shown in Fig. 4A, one form of the present technology, an anti-spill back valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-spill back valve is constructed and arranged to reduce the risk that water will flow upstream from the humidifier 5000, for example to the motor 4144.5.4.8 RPT device electrical components5.4.8.1 Power supply

[0333] A power supply 4210 may be located internal or external of the external housing 4010 of the RPT device 4000.

[0334] In one form of the present technology, power supply 4210 provides electrical power to the RPT device 4000 only. In another form of the present technology, power supply 4210 provides electrical power to both RPT device 4000 and humidifier 5000.5.4.8.2 Input devices

[0335] In one form of the present technology, an RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches or dials to allow a person to interact with the device. The buttons, switches or dials may be physical devices, or software devices accessible via a touch screen. The buttons, switches or dials may, in one form, be physically connected to the external housing 4010, or may, in another form, be in wireless communication with a receiver that is in electrical connection to the central controller 4230.

[0336] In one form, the input device 4220 may be constructed and arranged to allow a person to select a value and / or a menu option.5.4.8.3 Central controller

[0337] In one form of the present technology, the central controller 4230 is one or a plurality of processors suitable to control an RPT device 4000. The central controller 4230 is shown in Fig. 4B.

[0338] Suitable processors may include an x86 INTEL processor, a processor based on ARM® Cortex®-M processor from ARM Holdings such as an STM32 series microcontroller from ST MICROELECTRONIC. In certain alternative forms of the present technology, a 32-bit RISC CPU, such as an STR9 series microcontroller from ST MICROELECTRONICS or a 16-bit RISC CPU such as a processor from the MSP430 family of microcontrollers, manufactured by TEXAS INSTRUMENTS may also be suitable.

[0339] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0340] In one form, the central controller 4230 is an application-specific integrated circuit. In another form, the central controller 4230 comprises discrete electronic components.

[0341] The central controller 4230 may be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220, and / or the humidifier 5000.

[0342] The central controller 4230 may be configured to provide output signal(s) to one or more of an output device 4290, a pressure generator 4140, a therapy device controller 4240, a data communication interface 4280, and / or the humidifier 5000.

[0343] In some forms of the present technology, the central controller 4230 is configured to implement the one or more methodologies described herein, such as the one or more algorithms 4300 which may be implemented with processor-control instructions, expressed as computer programs stored in a non-transitory computer readable storage medium, such as memory 4260. In some forms of the present technology, the central controller 4230 may be integrated with an RPT device 4000. However, in some forms of the present technology, some methodologies may be performed by a remotely located device. For example, the remotely located device may determine control settings for a ventilator or detect respiratory related events by analysis of stored data such as from any of the sensors described herein.5.4.8.4 Clock

[0344] The RPT device 4000 may include a clock 4232 that is connected to the central controller 4230.5.4.8.5 Therapy device controller

[0345] In one form of the present technology, therapy device controller 4240 is a therapy control module 4330 that forms part of the algorithms 4300 executed by the central controller 4230.

[0346] In one form of the present technology, therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form a MC33035 brushless DC motor controller, manufactured by ONSEMI is used.5.4.8.6 Protection circuits

[0347] The one or more protection circuits 4250 in accordance with the present technology may comprise an electrical protection circuit, a temperature and / or pressure safety circuit.5.4.8.7 Memory

[0348] In accordance with one form of the present technology the RPT device 4000 includes memory 4260, e.g., non-volatile memory. In some forms, memory 4260 may include battery powered static RAM. In some forms, memory 4260 may include volatile RAM.

[0349] Memory 4260 may be located on the PCBA 4202. Memory 4260 may be in the form of EEPROM, or NAND flash.

[0350] Additionally, or alternatively, RPT device 4000 includes a removable form of memory 4260, for example a memory card made in accordance with the Secure Digital (SD) standard.

[0351] In one form of the present technology, the memory 4260 acts as a non- transitory computer readable storage medium on which is stored computer program instructions expressing the one or more methodologies described herein, such as the one or more algorithms 4300.5.4.8.8 Data communication systems

[0352] In one form of the present technology, a data communication interface 4280 is provided, and is connected to the central controller 4230 (see e.g., Fig. 4B). Data communication interface 4280 may be connectable to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 may be connectable to a remote external device 4286. The local external communication network 4284 may be connectable to a local external device 4288.

[0353] In one form, data communication interface 4280 is part of the central controller 4230. In another form, data communication interface 4280 is separate from the central controller 4230, and may comprise an integrated circuit or a processor.

[0354] In one form, remote external communication network 4282 is the Internet.The data communication interface 4280 may use wired communication (e.g. via Ethernet, or optical fibre) or a wireless protocol (e.g. CDMA, GSM, LTE) to connect to the Internet.

[0355] In one form, local external communication network 4284 utilises one or more communication standards, such as Bluetooth, or a consumer infrared protocol.

[0356] In one form, remote external device 4286 is one or more computers, for example a cluster of networked computers. In one form, remote external device 4286 may be virtual computers, rather than physical computers. In either case, such a remote external device 4286 may be accessible to an appropriately authorised person such as a clinician.

[0357] The local external device 4288 may be a personal computer, mobile phone, tablet or remote control.5.4.8.9 Output devices including optional display, alarms

[0358] An output device 4290 in accordance with the present technology may take the form of one or more of a visual, audio and haptic unit. A visual display may be a Liquid Crystal Display (LCD) or Light Emitting Diode (LED) display.5.4.8.9.1 Display driver

[0359] A display driver 4292 receives as an input the characters, symbols, or images intended for display on the display 4294, and converts them to commands that cause the display 4294 to display those characters, symbols, or images.5.4.8.9.2 Display

[0360] A display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an eight-segment display, in which case the display driver 4292 converts each character or symbol, such as the figure “0”, to eight logical signals indicating whether the eight respective segments are to be activated to display a particular character or symbol.

[0361] Referring now to Figs. 4A-4C, in some forms of the present technology, the central controller 4230 may be configured to implement one or more algorithms 4300 expressed as computer programs stored in a non-transitory computer readable storage medium, such as memory 4260. The algorithms 4300 are generally grouped into groups referred to as modules.

[0362] In other forms of the present technology, some portion or all of the algorithms 4300 may be implemented by a controller of an external device such as the local external device 4288 or the remote external device 4286. In such forms, data representing the input signals and / or intermediate algorithm outputs necessary for the portion of thealgorithms 4300 to be executed at the external device may be communicated to the external device via the local external communication network 4284 or the remote external communication network 4282. In such forms, the portion of the algorithms 4300 to be executed at the external device may be expressed as computer programs, such as with processor control instructions to be executed by one or more processor(s), stored in a non-transitory computer readable storage medium accessible to the controller of the external device. Such programs configure the controller of the external device to execute the portion of the algorithms 4300.

[0363] In such forms, the therapy parameters generated by the external device via the therapy engine module 4320 (if such forms part of the portion of the algorithms 4300 executed by the external device) may be communicated to the central controller 4230 to be passed to the therapy control module 4330.5.4.8.10 Pre-processing module

[0364] A pre-processing module 4310 in accordance with one form of the present technology receives as an input a signal from a transducer 4270, for example a flow rate sensor 4274 or pressure sensor 4272, and performs one or more process steps to calculate one or more output values that will be used as an input to another module, for example a therapy engine module 4320.

[0365] In one form of the present technology, the output values include the interface pressure Pm, the vent flow rate Qy, the respiratory flow rate Qr, and the leak flow rate QI.

[0366] In various forms of the present technology, the pre-processing module 4310 comprises one or more of the following algorithms: interface pressure estimation algorithm 4312, vent flow rate estimation algorithm 4314, leak flow rate estimation algorithm 4316, and respiratory flow rate estimation algorithm 4318.5.4.8.10.1 Interface pressure estimation

[0367] In one form of the present technology, an interface pressure estimation algorithm 4312 receives as inputs a signal from the pressure sensor 4272 indicative of the pressure in the pneumatic path proximal to an outlet of the pneumatic block (the device pressure Pd) and a signal from the flow rate sensor 4274 representative of the flow rate of the airflow leaving the RPT device 4000 (the device flow rate Qd). The device flow rateQd, absent any supplementary gas 4180, may be used as the total flow rate Qt. The interface pressure estimation algorithm 4312 estimates the pressure drop AP through the air circuit 4170. The dependence of the pressure drop AP on the total flow rate Qt may be modelled for the particular air circuit 4170 by a pressure drop characteristic AP(<2). The interface pressure estimation algorithm, 4312 then provides as an output an estimated pressure, Pm, in the patient interface 3000 or 3800. The pressure, Pm, in the patient interface 3000 or 3800 may be estimated as the device pressure Pd minus the air circuit pressure drop AP.5.4.8.10.2 Vent flow rate estimation

[0368] In one form of the present technology, a vent flow rate estimation algorithm 4314 receives as an input an estimated pressure, Pm, in the patient interface 3000 or 3800 from the interface pressure estimation algorithm 4312 and estimates a vent flow rate of air, Qv, from a vent 3400 in a patient interface 3000 or 3800. The dependence of the vent flow rate Qv on the interface pressure Pm for the particular vent 3400 in use may be modelled by a vent characteristic gv(Pm).5.4.8.10.3 Leak flow rate estimation

[0369] In one form of the present technology, a leak flow rate estimation algorithm 4316 receives as an input a total flow rate, Qt, and a vent flow rate Qv, and provides as an output an estimate of the leak flow rate QI. In one form, the leak flow rate estimation algorithm estimates the leak flow rate QI by calculating an average of the difference between total flow rate Qt and vent flow rate Qv over a period sufficiently long to include several breathing cycles, e.g. about 10 seconds.

[0370] In one form, the leak flow rate estimation algorithm 4316 receives as an input a total flow rate Qt, a vent flow rate Qv, and an estimated pressure, Pm, in the patient interface 3000 or 3800, and provides as an output a leak flow rate QI, by calculating a leak conductance, and determining a leak flow rate QI to be a function of leak conductance and pressure, Pm. Leak conductance is calculated as the quotient of low pass filtered non-vent flow rate equal to the difference between total flow rate Qt and vent flow rate Qv, and low pass filtered square root of pressure Pm, where the low pass filter time constant has a value sufficiently long to include several breathing cycles, e.g. about10 seconds. The leak flow rate Q\ may be estimated as the product of leak conductance and a function of pressure, Pm.5.4.8.10.4 Respiratory flow rate estimation

[0371] In one form of the present technology, a respiratory flow rate estimation algorithm 4318 receives as an input a total flow rate, Qt, a vent flow rate, Qv, and a leak flow rate, QI, and estimates a respiratory flow rate of air, Qr, to the patient, by subtracting the vent flow rate Qv and the leak flow rate QI from the total flow rate Qt.5.4.8.11 Therapy Engine Module

[0372] In one form of the present technology, a therapy engine module 4320 receives as inputs one or more of a pressure, Pm, in a patient interface 3000 or 3800, and a respiratory flow rate of air to a patient, Qr, and provides as an output one or more therapy parameters.

[0373] In one form of the present technology, a therapy parameter is a treatment pressure Pt.

[0374] In one form of the present technology, therapy parameters are one or more of an amplitude of a pressure variation, a base pressure, and a target ventilation.

[0375] In various forms, the therapy engine module 4320 comprises one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow limitation determination 4324, apnea / hypopnea determination 4325, snore determination 4326, airway patency determination 4327, target ventilation determination 4328, and therapy parameter determination 4329.5.4.8.11.1 Phase determination

[0376] In one form of the present technology, the RPT device 4000 does not determine phase.

[0377] In one form of the present technology, a phase determination algorithm 4321 receives as an input a signal indicative of respiratory flow rate, Qr, and provides as an output a phase <h of a current breathing cycle of a patient 1000.5.4.8.11.2 Waveform determination

[0378] In one form of the present technology, the therapy parameter determination algorithm 4329 provides an approximately constant treatment pressure throughout a respiratory cycle of a patient.

[0379] In other forms of the present technology, the therapy control module 4330 controls the pressure generator 4140 to provide a treatment pressure Pt that varies as a function of phase <h of a respiratory cycle of a patient according to a waveform template n( ).

[0380] In one form of the present technology, a waveform determination algorithm4322 provides a waveform template II(Q) with values in the range [0, 1] on the domain of phase values <5 provided by the phase determination algorithm 4321 to be used by the therapy parameter determination algorithm 4329.5.4.8.11.3 Ventilation determination

[0381] In one form of the present technology, a ventilation determination algorithm4323 receives an input a respiratory flow rate Qr, and determines a measure indicative of current patient ventilation, Vent.5.4.8.11.4 Determination of Inspiratory Flow Limitation

[0382] In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 for the determination of the extent of inspiratory flow limitation.5.4.8.11.5 Determination of apneas and hypopneas

[0383] In one form of the present technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 for the determination of the presence of apneas and / or hypopneas.5.4.8.11.6 Determination of snore

[0384] In one form of the present technology, the central controller 4230 executes one or more snore determination algorithms 4326 for the determination of the extent of snore.5.4.8.11.7 Determination of airway patency

[0385] In one form of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 for the determination of the extent of airway patency.5.4.8.11.8 Determination of target ventilation

[0386] In one form of the present technology, the central controller 4230 takes as input the measure of current ventilation, Vent, and executes one or more target ventilationdetermination algorithms 4328 for the determination of a target value Vtgt for the measure of ventilation.5.4.8.11.9 Determination of therapy parameters

[0387] In some forms of the present technology, the central controller 4230 executes one or more therapy parameter determination algorithms 4329 for the determination of one or more therapy parameters using the values returned by one or more of the other algorithms in the therapy engine module 4320.5.4.8.12 Therapy Control module

[0388] The therapy control module 4330 in accordance with one aspect of the present technology receives as inputs the therapy parameters from the therapy parameter determination algorithm 4329 of the therapy engine module 4320, and controls the pressure generator 4140 to deliver a flow of air in accordance with the therapy parameters.

[0389] In one form of the present technology, the therapy parameter is a treatment pressure Pt, and the therapy control module 4330 controls the pressure generator 4140 to deliver a flow of air whose interface pressure Pm at the patient interface 3000 or 3800 is equal to the treatment pressure Pt.5.4.8.13 Detection of fault conditions

[0390] In one form of the present technology, the central controller 4230 executes one or more methods 4340 for the detection of fault conditions. The fault conditions detected by the one or more methods 4340 may include at least one of the following:• Power failure (no power, or insufficient power)• Transducer fault detection• Failure to detect the presence of a component• Operating parameters outside recommended ranges (e.g. pressure, flow rate, temperature, PaO2)• Failure of a test alarm to generate a detectable alarm signal.

[0391] Upon detection of the fault condition, the corresponding algorithm signals the presence of the fault by one or more of the following:• Initiation of an audible, visual & / or kinetic (e.g. vibrating) alarm• Sending a message to an external device• Logging of the incident5.5 PATIENT INTERFACE DETECTION

[0392] Fig. 6 illustrates a schematic view of a respiratory therapy system 8000.The Respiratory therapy system 8000 may be configured to wirelessly detect information about the patient interface 3000 or an accessory that a patient is using during a therapy session. In some aspects, incorporation of the technology described further below may create a patient interface (or accessory) detection system in which a patient does not need to manually scan in or input (e.g., via an external device like a smartphone, computer, or tablet, or via mechanism within the respiratory therapy system) the type of patient interface being used. In other aspects, incorporation of a wireless patient interface detection system may allow the respiratory therapy system 8000 to confirm the accuracy of a patient’s input regarding the type of patient interface (or accessory) being used, or may track usage or other characteristics of the patient interface (or accessory) in use, as described further below.

[0393] The respiratory therapy system 8000 includes the patient interface 3000 and the respiratory pressure therapy (RPT) device 4000 fluidly coupled by the air circuit 4170, which may be a conduit or tube, as described above. As further described above, the RPT device 4000 is configured to supply a flow of gas, for example, air, which may be supplemented with oxygen, through the air circuit 4170 to the patient interface 3000. The RPT device 4000 may include any of the elements described above, such as a humidifier, an oxygen source, and / or data management systems.

[0394] The RPT device 4000 may be used individually or as part of the system 8000 to deliver one or more of a number of therapies described above, such as by operating the device to generate a flow of air for delivery to an interface (e.g., the patient interface 3000) to the airways of the user. The flow of air may be pressure-controlled (for respiratory pressure therapies) or flow-controlled (for flow therapies such as HFT). Thus the RPT device 4000 may also act as a flow therapy device. The RPT device 4000 may, for example, include a CPAP device and / or a ventilator.

[0395] The respiratory therapy system 8000 may further comprise a Radio Frequency Identification (RFID) system 9000. The RFID system 9000 may, for example, be configured to detect one or more characteristics of the respiratory therapy beingdelivered from the RPT device 4000 to the patient interface 3000, the identification of the patient interface 3000, and / or the identification of an accessory device (not shown) directly or indirectly coupled to the respiratory therapy system 8000. Exemplary accessory devices may include, but are not limited to, a patient interface headgear, a cushion on the patient interface 3000, an air filter, a humidifier, one or more components of a humidification system (e.g., components of a heat and moisture exchanger or waterless humidifier), a conduit, and / or an adapter accessory.

[0396] RFID is a form of wireless communication that incorporates the use of electromagnetic or electrostatic coupling in the radio frequency portion of the electromagnetic spectrum, for example, to uniquely identify and / or track an object. The RFID system 9000 may operate according to the principle of inductive coupling.

[0397] The RFID system 9000 includes a transponder 9200 (hereinafter referred to as a “tag”), a transceiver 9300, and an antenna 9100. In some embodiments, the RFID system 9000 includes one antenna 9100. In alternative embodiments, the RFID system 9000 includes two or more antennas 9100. The antenna 9100 is configured to emit radio waves and receive reflected signals, for example, from the tag 9200. The antenna 9100 may be a linear antenna, and thus may emit a linear polarized signal, or the antenna 9100 may be a circular antenna, and thus may emit a circularly polarized signal. In some embodiments, the RFID system 9000 may include both linear antenna(s) and circular antenna(s).

[0398] The antenna 9100 may be disposed within a proximal portion (e.g., near the patient interface 3000) of the air circuit 4170. For example, the antenna 9100 may be disposed within a portion of the air circuit 4170, such as, for example, within a cover 4172 on a proximal portion 4170A of the air circuit 4170. In alternative embodiments, the antenna 9100 may be disposed within a lumen of air circuit 4170. In further alternative configurations, the antenna 9100 may be fixedly or removably coupled to an external portion of the air circuit 4170, such as, for example, on an external surface of the air circuit 4170. In further alternative embodiments, antenna 9100 may be disposed between components of respiratory system 8000, for example, between patient interface 3000 and air circuit 4170 and / or between RPT device 4000 and air circuit 4170. Further still,antenna 9100 may be placed externally to respiratory system 8000. For example, antenna 9100 may be external to RPT device 4000, air circuit 4170, and patient interface 3000.

[0399] The tag 9200 is configured to emit radio waves to transmit information. The tag 9200 may contain a microchip or a circuit board that stores and processes information such as, for example, the unique identifier of the tag 9200 and the antenna 9100 to enable the tag 9200 to receive and / or transmit radio signals. The tag 9200 may be an active tag or a passive tag. If a passive tag is used, it may rely on the power of the antenna to transmit data, and thus may have a shorter transmittal range. For example, the tag 9200 may receive all of the required energy from a magnetic field in which the tag 9200 operates.

[0400] The tag 9200 may be read-only, read / write, or write once, read many. The tag 9200 may be configured to include identifying data of the patient interface 3000 and / or the patient. In some aspects, the tag 9200 may include information related to a date of usage or a time stamp. The tag 9200 may additionally or alternatively include information related to the type of patient interface 3000 being used, characteristics of patient interface 3000 (e.g., one or more of cushion material, cushion size, conduit size, patient interface size, length of use of the patient interface, date of manufacture of the patient interface, a set of respiratory therapy conditions the patient interface is suitable for use with, etc.), a serial identification number of the patient interface 3000, a production batch identification number of the patient interface 3000, and / or other aspects of the respiratory therapy system 8000. In some aspects, the tag 9200 may be configured to include patient information, e.g., the type of therapy or therapy settings the patient is intended to receive, or other information. The tag 9200 may also be used to detect a connection and / or a disconnection of the air circuit 4170 and / or an accessory device (not shown).

[0401] As will be discussed in further detail below, in some embodiments, the tag 9200 may include an adhesive, e.g., to assist in applying the tag 9200 to the patient interface 3000 and / or maintaining the tag 9200 in place on the patient interface 3000 after application. The tag 9200 may alternatively be overmolded within a portion of patient interface 3000. For example, the tag 9200 may be overmolded into a soft plastic material, e.g., a silicone cushion, or into a hard plastic material, e.g., a plastic frame of the patient interface 3000. Alternatively, the tag 9200 may comprise conductive silicone and / orconductive thread(s) or ink(s) (e.g., silver ink) printed on the soft and / or hard plastic material comprising patient interface 3000. The tag 9200 may include, e.g., overmolded inlay label, conductive textile, or may be coupled to the patient interface 3000 in any suitable method used in the art. In some embodiments, one or more surfaces of tag 9200 may be treated, for example, to improve adhesion to patient interface 3000, a headgear tube 3350 of a conduit headgear, and / or other components of respiratory therapy system 8000. Additionally or alternatively, an adhesive or a primer may be applied to a surface of tag 9200. In some embodiments, one or more surfaces of tag 9200 may comprise one or more features configured to increase a surface area of tag 9200. For example, a surface of tag 9200 may include one or more holes, protrusions, indentions, or a combination thereof to facilitate inclusion into one or more components of the respiratory therapy system 8000.

[0402] The tag 9200 may be an RFID tag, and, in some instances, may be a nearfield communication (NFC) tag. The tag 9200 may be configured to generate an electromagnetic field with a frequency of about 10 MHz to about 12GHz (e.g., about 13.56 megahertz (MHz)), and the antenna 9100 may be configured to read data transmitted from tag 9200 at about 10 MHz to about 12GHz (e.g., about 13.56 MHz). In other aspects, the RFID system 9000 may alternatively be configured to generate an electromagnetic field with a frequency between about 30 kilohertz (kHz) and about 3 gigahertz (GHz). In some examples, RFID system 9000 may be configured to operate in a low frequency range, or between about 30 kHz to 300 kHz. Accordingly, the RFID system 9000 may be configured to have a read range of up to approximately 10 centimetres (approximately 3.94 inches), although the exact distance may vary depending, e.g., on the angles of the various components in the system relative to one another. Alternatively, the RFID system 9000 may be configured to operate in a high frequency range, or between about 3 MHz and 30 MHz. In such a configuration, the RFID system 9000 may be configured to have a read range between approximately 10 centimetres up to approximately one metre (approximately 3.94 inches to approximately 39.37 inches).

[0403] Further still, the RFID system 9000 may be configured to operate in an ultra- high frequency range, or between about 300 MHz and 3 GHz. In such a configuration, theRFID system 9000 may be configured to have a read range between approximately one metre up to approximately 12 metres. For example, the tag 9200 may be an ultra-high frequency (UHF) tag, a Bluetooth tag, or an ultra wideband (UWB) tag. The tag 9200 and the antenna 9100 may be tuned to operate on the same frequency. A UWB tag 9200 may operate at a frequency range of about 3.1GHz to about 10.6GHz, a Bluetooth tag 9200 may operate at a frequency of about 2.5GHz, and a UHF tag 9200 may operate at a frequency of about 300MHz to about 3AHz.

[0404] In some examples, a shorter read range for the RFID system 9000 may be desirable. For example, if the patient is in the vicinity of multiple device or objects containing RFID components, the RFID system 9000 may inadvertently read the tag or antenna on the peripheral devices. Accordingly, if the RFID system 9000 is configured to operate on a low frequency range, e.g., at 13.56 MHz, the possibility for the RFID system 9000 to read a peripheral device inadvertently is decreased.

[0405] The RFID system 9000 may include a single tag 9200 fixedly or removably coupled to patient interface 3000 or to an accessory device (not shown). Alternatively, the RFID system 9000 may include two or more of the tags 9200 fixedly coupled to the patient interface 3000 or to an accessory device (not shown). The RFID tags 9200 described herein may be off-the-shelf components or may be customized according to a size and / or a shape of patient interface 3000 and / or according to a desired read range for tag 9200. Although tag 9200 is described herein as being associated with the patient interface 3000, tag 9200 may alternatively or additionally be associated with, for example, the air circuit 4170 or another accessory of respiratory therapy system 8000. To the extent that tag 9200 is associated with air circuit 4170 or another accessory, tag 9200 may include information about the accessory or air circuit with which it is associated. Although tag 9200 is shown as being coupled to patient interface 3000 in Fig. 6 the placement of tag 9200 shall not be so limited. For example, tag 9200 may be on or in any portion of the respiratory therapy system 8000. For example, tag 9200 may be on / in air circuit 4170, RPT device 4000, and / or an accessory device (not shown). In some embodiments, tag 9200 may be between two components of the respiratory therapy system 8000. For example, tag 9200 may be between patient interface 3000 and air circuit 4170 and / or between RPT device 4000 and air circuit 4170.

[0406] The antenna 9100 is configured to receive data from the tag 9200 and transmit the received data to the transceiver, or reader, 9300. The antenna 9100 may be set to the same inductance for the tags 9200 for different types of the patient interface 3000 so that the antenna 9100 may be compatible with a variety of patient interfaces 3000. The transceiver 9300 may be operably connected to the antenna 9100 physically (e.g., via a wire) and may be located on or in the air circuit 4170 or the adapter 9400. In one configuration, the transceiver 9300 may be located on or in the RPT device 4000. In one configuration, the transceiver 9300 may be external to the respiratory therapy system 8000. For example, the transceiver 9300 may be a scanner, a smartphone, a tablet, or any other device configured to receive transmitted RFID signals from an RFID tag or antenna. Accordingly, the antenna 9100 is configured to communicate data received from the tag 9200 to the transceiver 9300. Antenna 9100 may comprise a flexible circuit board. The transceiver 9300 may also be configured to save or store the transmitted data from the antenna 9100.

[0407] Referring still to Fig. 6, the transceiver 9300 may include a controller on a flexible circuit, for example, attached within the air circuit 4170. The transceiver 9300 may relay information from the antenna 9100 to a controller configured to control the RPT device 4000. The controller may be separate from the RPT device 4000 or may be incorporated as part of the RPT device 4000. The controller may function as described above. The transceiver 9300 may generate an electromagnetic field with an appropriate frequency, e.g., of 13.56 MHz, and may be configured to read the tag 9200 from patient interface 3000 or an accessory coupled at the patient interface 3000. Accessory parts may include, but are not limited to, e.g., one or more of headgear of the patient interface, cushion, heat and moisture exchanger or waterless humidifiers, an air filter, an air conduit, or an adapter, as described above.

[0408] In some configurations, the transceiver 9300 may be configured to transmit data to the RPT device 4000 physically (e.g., via a wire) or wirelessly. The RPT device 4000 may also be configured to save or store the transmitted data from transceiver 9300, interpret the transmitted data, and / or transmit an alert or signal to the user or care provider, as described above. In some embodiments, the RPT device 4000 may also be configured to automatically change one or more characteristics of the respiratory pressuretherapy, for example, based on the raw data and / or interpreted data received from the transceiver 9300. Additionally or alternatively, the RPT device 4000 may be configured to suggest one or more therapy settings, for example, to promote patient care and / or patient comfort based on the interpreted data from the transceiver 9300, as will be discussed further below.

[0409] In order to integrate antenna 9100 and / or tag 9200 into one or more components of the respiratory therapy system 8000, one or more circuit boards, e.g., flexible printed circuit boards, of antenna 9100 and / or tag 9200 may be overmolded with silicone, such as liquid silicone rubber. Yet, it may be difficult to bond the liquid silicone rubber to a flexible printed circuit board, as little to no bonding may occur naturally between the liquid silicone rubber and the flexible printed circuit board. This may result in the liquid silicone rubber peeling off from the flexible printed circuit board of the antenna 9100 and / or tag 9200. Such a result may impair the ability to successfully incorporate antenna 9100 and / or tag 9200 into a component of the respiratory therapy system 8000. One or more of the aspects below may be used to promote retention of silicone, e.g., liquid silicone rubber, or other flexible materials, onto a printed circuit board.

[0410] Fig. 7A illustrates a perspective view of an exemplary circuit board 9210 (hereinafter referred to as “board” 9210). Fig. 7B illustrates a side cross-sectional view of board 9210 shown in Fig. 7A. Tag 9200 (of Fig. 6) may comprise board 9210. For example, board 9210 may be a microchip configured to store and process information in tag 9200. Such information may include, for example, the unique identifier of the tag 9200 and the antenna 9100, so as to enable the tag 9200 to receive and / or transmit radio signals, as described above with respect to Fig. 6. In some examples, board 9210 may be a microchip incorporated as part of an antenna (e.g., antenna 9100). Although a single board 9210 is shown, antenna 9100 and / or tag 9200 of Fig. 6 may include additional (e.g., two or more) boards 9210. In some examples, board 9210 may be coupled or bonded to a surface of one or more components of the respiratory therapy system 8000. In other examples, board 9210 (of tag 9200 and / or antenna 9100) may be overmolded with or onto one or more components of the respiratory therapy system 8000. Forexample, board 9210 may be embedded in or formed with the one or more components of the respiratory system 8000, such as a patient interface, headgear tube, or air circuit.

[0411] Board 9210 may be a flexible printed circuit (FPC) comprising at least three layers: a first layer 9212, a second layer 9214, and a third layer 9216. Second layer 9214 may be disposed between first layer 9212 and third layer 9216. In some examples, board 9210 may include one or more openings 9218.

[0412] One or more opening(s) 9218 may extend through an entirety of first layer 9212, for example, to expose a portion of second layer 9214. Opening(s) 9218 may be configured such that a user may couple or solder electrical elements (e.g., wires, cables, etc.) to second layer 9214 of board 9210. Although not shown, third layer 9216 may include one or more opening(s) 9218. For example, both first layer 9212 and third layer 9216 may have opening(s) 9218 extending through each respective layer and exposing a portion of second layer 9214.

[0413] In some examples, just one of first layer 9212 and third layer 9216 may have opening(s) 9218 extending through each respective layer. Although three rectangular opening(s) 9218 are shown on a discrete portion of board 9210, opening(s) 9218 may be positioned on any portion of board 9210 and may have any suitable shape and / or size. For example, opening(s) 9218 may be circular openings randomly positioned on first layer 9212 and / or third layer 9216. In some examples, opening(s) 9218 may be circular on first layer 9212 and rectangular on third layer 9216. Other combinations or configurations of opening(s) 9218 on first layer 9212 and / or third layer 9216 are contemplated.

[0414] Each of first layer 9212 and third layer 9216 may overlay, and may serve as a solder resist for, flexible printed circuit boards. First layer 9212 and third layer 9216 may be configured to encapsulate and protect the circuitry contained on or within second layer 9214. Second layer 9214 may be formed of a conductive material (e.g., copper), to permit electrical connections between components. First layer 9212 and third layer 9216 may be glued or otherwise affixed to opposing surfaces of second layer 9214 to protect the conductive, e.g., copper, structure.

[0415] In some examples, first layer 9212 and / or third layer 9216 may comprise polyimide or another amorphous plastic that exhibits temperature stability, flexibility, and high strength. For example, each of first layer 9212 and third layer 9216 may be solder-resistant. In some examples, a surface of each of first layer 9212 and third layer 9216 that touches, or abuts, respective surfaces of second layer 9214 may include an epoxy and / or an adhesive. In such a way, first layer 9212 may be bonded to a first surface of second layer 9214, and third layer 9216 may be bonded to a second surface of second layer 9214. For example, first layer 9212, second layer 9214, and third layer 9216 may be laminated under heat and pressure to form board 9210. Although three layers (9212, 9214, 9216) are shown, board 9210 may comprise additional layers.

[0416] In some examples, board 9210 of tag 9200 and / or antenna 9100 may be bonded or coupled to one or more components of the respiratory therapy system, e.g., a patient interface, headgear tube, and / or air circuit. For example, as shown and described above with respect to Fig. 6, board 9210 may be coupled to patient interface 3000. Additionally or alternatively, board 9210 may be coupled to a headgear tube 3350 of a conduit headgear and / or other components of respiratory therapy system 8000. In some aspects, board 9210 of tag 9200 and / or antenna 9100 may be overmolded to a material, such as silicone (e.g., liquid silicone rubber), in order to incorporate board 9210 into one or more components.

[0417] In some examples, an outer surface of first layer 9212 (i.e., a surface of first layer 9212 opposite to the surface facing second layer 9214) and / or an outer surface of third layer 9216 (i.e., a surface of third layer 9216 opposite to the surface facing second layer 9214) may be bonded or coupled to the one or more components of the respiratory therapy system 8000. The one or more components of the respiratory therapy system 8000 may comprise a variety of materials. For example, the components of the respiratory therapy system 8000 may comprise a variety of hard and soft plastics and / or silicone. As described above, challenges may arise with bonding first layer 9212 and / or third layer 9216 to the component(s) of the respiratory therapy system 8000. Specifically, bonding to polyimide, the material commonly used for overlays (e.g., first layer 9212 and third layer 9216), may be difficult. For example, due to the high thermal stability, low surface energy, non-polar nature, and / or chemical resistance of polyimide, difficulties may arise with bonding board 9210 to one or more components of the respiratory therapy system.

[0418] To overcome such challenges, the material of first layer 9212 and / or third layer 9216 may be selected to promote bonding with other materials. For example, first layer 9212 and / or third layer 9216 may comprise thermoplastic polyurethanes (TPU or TPE-U) and / or thermoplastic polyurethane blends. For example, TPUs may be desirable due to the chemical structure, moderate to high surface energy, compatibility with adhesives, among other properties of TPUs.

[0419] First layer 9212 and / or third layer 9216 may alternatively comprise polyethylene terephthalate (PET) and / or a silicone film. For example, PETs may be desirable due to their high surface energy, surface texture, and compatibility with adhesives, among other aspects. Silicone films may be desirable for similar reasons.

[0420] TPU, PET, and / or silicone may be advantageous for a number of reasons. For example, TPU, PET, and / or silicone materials may be advantageous due to each material’s ability to stretch and / or flex. For example, because of the stretchability and / or flexibility of TPU, PET, and / or silicone, a board 9210 comprising such material(s) may allow for board 9210 to be bent and / or otherwise formed to complex shapes. TPU, PET, and / or silicone may also be advantageous due each material’s high heat tolerances. For example, circuit traces may be sintered directly on to circuit boards (e.g., board 9210) comprising TPU, PET and / or silicone. TPU, PET, and / or silicone may also be advantageous due to each material’s biocompatibility and / or each material’s resistance to chemicals or moisture. For example, boards comprising TPU, PET, and / or silicone may be resistant to corrosion due to exposure of dilute acids, oils, solvents, ozone, tar, and / or other chemicals. Other materials with one or more similar characteristics may also be suitable for use as first layer 9212 and / or third layer 9216.

[0421] In some examples, first layer 9212 may comprise a first material, and third layer 9216 may comprise a second material. For example, first layer 9212 may comprise a TPU, and third layer 9216 may comprise a PET.

[0422] In some aspects, the first layer 9212 and / or the third layer 9216 may include an outer surface having an improved bonding strength, improved adhesion capabilities, a higher surface roughness and / or improved coupling capabilities relative to an inner surface thereof, wherein the inner surface thereof is affixed to the second layer 9214.

[0423] Still referring to Figs. 7A and 7B, in some examples, a surface of first layer 9212 and / or third layer 9216 may be treated, for example, to improve adhesion capabilities and bond with other materials. For example, an outer surface of one or both of first layer 9212 and third layer 9216 may be subjected to a plasma treatment and / or a corona treatment. Plasma treatment and / or a corona treatment may be used for first layer 9212 and / or third layer 9216 formed of any of the materials described above, including polyimide or another amorphous plastic, TPUs, PETs, and / or a silicone film.

[0424] Plasma treatment is a surface treatment technique used to modify the surface properties of materials. Specifically, plasma treatment is a low-pressure gas process that removes organic contamination, for example, to improve acceptance of secondary manufacturing processes. For example, a surface of the material may be microscopically etched so as to improve bond strength without otherwise altering the clarity, haze, transmittance, or other visual properties of the material. Plasma treatment can be performed using various gases, such as oxygen, nitrogen, argon, or a mixture of gases, depending on the desired surface modification. Corona treatment is a surface treatment technique used to increase the surface energy. Specifically, a corona treatment is accomplished by applying a voltage when a material is in a corona treatment machine. When the voltage is applied, the surrounding oxygen molecules are broken down into atoms. The generated atoms can bond with the molecule end present in the material that is being treated, thus chemically activating the surface. When the atoms bond to the molecules of the material, surface tension may increase such that the surface becomes more receptive to adhesion.

[0425] An entirety of the outer surface of first layer 9212 and / or third layer 9216 may be treated using one or more of these surface treatment techniques. Alternatively, one or more discrete portions of the outer surface of first layer 9212 and / or third layer 9216 may be treated. For example, an outer perimeter of first layer 9212 and / or third layer 9216 may be treated, the corners of first layer 9212 and / or third layer 9216, and / or a center portion of first layer 9212 and / or third layer 9216 may be treated. In some examples, first layer 9212 may undergo a first treatment and third layer 9216 may undergo a different, second treatment, such that the surface properties on each side of board 9210 are different.

[0426] In other examples, an adhesive and / or primer material may be applied to the outer surface of first layer 9212 and / or third layer 9216. In some examples, the adhesive and / or primer may be applied to a surface of the component of a respiratory therapy system 8000 onto which board 9210 is to be affixed. For example, the adhesive and / or primer may be applied to a surface of patient interface 3000, discussed above. The adhesive and / or primer may serve as an intermediary conduit between the outer surface of first layer 9212 and / or third layer 9216 and the component of the respiratory therapy system 8000 and / or another encapsulating material. For example, the adhesive and / or primer may promote adhesion of the outer surface of first layer 9212 and / or third layer 9216 with other materials.

[0427] A variety of primers and / or adhesives may be used. Primers are surface coatings that change one or more characteristics of a surface of a material such that an adhesive will adhere to the material more effectively. For example, primers may change the surface energy of the material. Primers may include plastic adhesion promoters, vinyl chloride copolymer primers, acrylic -based primers, polyurethane primers, epoxy -based primers, or any combination of the like. Primers may be used in conjunction with adhesives. For example, a primer may be applied to the surface before an adhesive is used. Adhesives may include epoxies, polyurethanes, acrylics, cyanoacrylate, polyvinyl acetate, anaerobic adhesives, or any combination of the like.

[0428] The adhesive and / or primer may be applied to an entirety of the outer surface of first layer 9212 and / or third layer 9216. Alternatively, the adhesive and / or primer may be applied to one or more discrete portions of the outer surface of first layer 9212 and / or third layer 9216. For example, the adhesive and / or primer may be applied to an outer perimeter of first layer 9212 and / or third layer 9216, the corners of first layer 9212 and / or third layer 9216, and / or a center portion of first layer 9212 and / or third layer 9216. In some examples, a first adhesive and / or primer may be applied to the outer surface of first layer 9212, and a second adhesive and / or primer may be applied to the outer surface of third layer 9216.

[0429] In one example, a silicone-compatible primer may be applied to the outer surface of first layer 9212 and / or third layer 9216. Such a primer may comprise a solventbased carrier containing reactive silane groups. When the primer is applied to first layer9212 and / or third layer 9216 and exposed to moisture, the silane groups may become active, facilitating adhesion between silicone and its corresponding substrate.

[0430] Additionally or alternatively, the outer surface of first layer 9212 and / or third layer 9216 may be etched. For example, a thin layer of material of the outer layers of first layer 9212 and / or third layer 9216 may be removed to increase the roughness of the surface. For example, roughening the surface may promote adhesion to other materials by increasing the surface area. Etching may be done to an entirety of the surface of the outer surface of first layer 9212 and / or third layer 9216 or to one or more discrete portions of the outer surface of first layer 9212 and / or third layer 9216.

[0431] Each example discussed herein may be used alone or in combination with one or more techniques. For example, the material of first layer 9212 and / or third layer 9216 may be changed and / or an adhesive may be applied to the outer surface of first layer 9212 and / or third layer 9216. In other examples, first layer 9212 and / or third layer 9216 may comprise a polyimide and / or the outer surface of first layer 9212 and / or third layer 9216 may be etched. Additionally or alternatively, a primer or adhesive may be applied to the etched outer surface of first layer 9212 and / or third layer 9216. Various combinations are contemplated, for example, to enhance or improve adhesion between board 9210 and component(s) of the respiratory therapy system 8000 (e.g., patient interface 3000) or other materials that facilitate inclusion within respiratory therapy system 8000.

[0432] Additionally or alternatively, one or more outer surfaces may include one or more features configured, for example, to increase surface adhesion with plastic or silicone materials. For example, the feature(s) may be configured to improve mechanical interlocking between the board 9210 and a material with which the board is being overmolded with, such as, for example, a silicone or plastic. The one or more features may create a texturing on first layer 9212 and / or third layer 9216 to promote coupling of a material with board 9210.

[0433] Fig. 8A is a perspective view of a portion of an alternate board 9210-A. Figs. 8B and 8C are a cross-sectional views of board 9210-A. Board 9210-A may have any or all of the characteristics of board 9210 described above with respect to Figs. 7A and 7B, except as described below. For example, board 9210-A may have a first layer 9212-A, a second layer 9214- A, and a third layer 9216- A. Each layer 9212-A, 9214- A, 9216- A ofboard 9210- A may have any or all of the characteristics of the respective layers 9212, 9214, 9216 of board 9210. For example, second layer 9214-A may be disposed between first layer 9212- A and third layer 9216- A. Second layer 9214-A may comprise a conductive, e.g., copper, material. First layer 9212-A and / or third layer 9216-A may comprise a polyimide material or other materials as described above.

[0434] One or more features 9220 may be disposed on an outer surface of a first layer 9212-A. Although not shown, feature(s) 9220 may additionally or alternatively be disposed on an outer surface of a third layer 9216-A. Feature(s) 9220 may include indentation / s) 9220', as shown in Fig. 8B, and / or projection(s) 9220", as shown in Fig. 8C. In some examples, first layer 9212-A and / or third layer 9216-A may include a combination of both indentations 9220' and projections 9220". Indentations 9220' and / or projection 9220" may be collectively referred to herein as feature(s) 9220.

[0435] The feature(s) 9220 may be disposed across an entirety of the outer surface of first layer 9212-A and / or third layer 9216-A. For example, feature(s) 9220 may be disposed randomly across the outer surface of first layer 9212-A and / or third layer 9216- A. In some examples, feature(s) 9220 may be disposed on first layer 9212-A and / or third layer 9216-A in a pattern (e.g., a series of rows, columns, diagonals, etc.). Alternatively, one or more discrete portions of the outer surface of first layer 9212-A and / or third layer 9216-A may include feature(s) 9220. For example, an outer perimeter of first layer 9212- A and / or third layer 9216-A may include feature(s) 9220, the corners of first layer 9212- A and / or third layer 9216-A, and / or a central region of first layer 9212-A and / or third layer 9216-A may include feature(s) 9220. In some examples, first layer 9212-A may include a first type of feature(s) 9220 (e.g., indentations 9220') and third layer 9216-A may include a second type of feature(s) 9220 (e.g., projections 9220"). The feature(s) 9220 may increase the surface area of first layer 9212-A and / or third layer 9216-A, thus increasing the adhesion of another material with board 9210- A.

[0436] Figs. 9A-9C illustrate alternative examples of features 9220'" in the form of projections on a board 9210-B. Board 9210-B may have any and / or all of the features of board 9210 of Figs. 7A and 7B and / or board 9210-A of Figs. 8A-8C. The plurality of features 9220'" illustrated in Figs. 9A-9C may be configured such that a material may flow around each feature of features 9220'", for example, during an overmolding orbonding process, so as to secure a board 9210-B to or in the material. In some examples, board 9210-B may include one or more indentations (e.g., features 9220' of Fig. 8B) and / or projections (e.g., features 9220" of Fig. 8C) in combination with features 9220"'.

[0437] Fig. 9A illustrates a plurality of mushroom, or t-shaped features 9220-A. Features 9220-A may include a base 9221 and a top 9222. A width of base 9221 may be smaller than a width of top 9222. Base 9221 and top 9222 may be integrally formed and / or may be separate components coupled together. During the overmolding or bonding process, material may flow around or between features 9220-A, for example around base 9221. In some examples, the material may flow around base 9221 and over top 9222, for example, to fully encapsulate features 9220-A within the material. The narrower shape of features 9220-A closer to a main surface of first layer 9212-B and / or third layer 9216-B may promote engagement of the material to board 9210-B.

[0438] Fig. 9B illustrates an alternative projection 9220-B. Projection 9220-B may be configured similar to an upside down cone or frustoconical. For example, projection 9220-B includes a top surface 9223 and a side surface 9224. Side surface 9224 may be angled inwards. For example, top surface 9223 may have a greater width than a width of the base of projection 9220-B. During the overmolding or bonding process, material may flow around or between projections 9220-B, for example around side surface 9224. In some examples, the material may flow around side surface 9224 and over top surface 9223, for example, to fully encapsulate projections 9220-B within the material. Again, the narrower shape of features 9220-B closer to a main surface of first layer 9212-B and / or third layer 9216-B may promote engagement of the material to board 9210-B.

[0439] Fig. 9C illustrates an alternative projection 9220-C. Projection 9220-C may be L- shaped. For example, projection 9220-C may include a first portion 9225 coupled to the outer surface of first layer 9212-B. An arm 9226 may extend laterally (e.g., either at a perpendicular angle to first portion 9225 or at an angle of greater or less than 90 degrees) outward from first portion 9225. During the overmolding or bonding process, material may flow around or between projections 9220-C, for example around first portion 9225. In some examples, the material may flow around first portion 9225 and over arm 9226, for example, to fully encapsulate projections 9220-C within the material. The narrowershape of features 9220-C closer to a main surface of first layer 9212-B and / or third layer 9216-B may promote engagement of the material to board 9210-B.

[0440] Protrusion 9220- A, 9220-B, and / or 9220-C may be disposed across an entirety of the outer surface of first layer 9212-B and / or third layer 9216-B. For example, protrusion 9220- A, 9220-B, and / or 9220-C may be disposed randomly across the outer surface first layer 9212-B and / or third layer 9216-B. In some examples, protrusion 9220- A, 9220-B, and / or 9220-C may be disposed on first layer 9212-B and / or third layer 9216- B in a pattern (e.g., a series of rows, columns, diagonals, etc.). Alternatively, one or more discrete portions of the outer surface of first layer 9212-B and / or third layer 9216-B may include protrusion 9220- A, 9220-B, and / or 9220-C. For example, an outer perimeter of first layer 9212-B and / or third layer 9216-B may include protrusion 9220- A, 9220-B, and / or 9220-C, the corners of first layer 9212-B and / or third layer 9216-B, and / or a central region of first layer 9212-B and / or third layer 9216-B may include protrusions 9220-A, 9220-B, and / or 9220-C. In some examples, first layer 9212-B may include a first type of protrusions 9220-A, 9220-B, and / or 9220-C, and third layer 9216-B may include a second type of protrusions 9220-A, 9220-B, and / or 9220-C. Or first layer 9212-B and / or third layer 9216-B may include a combination of protrusion types. Although mushroom, frustoconical, and L-shaped protrusion types are depicted herein, any protrusion having a width that decreases as it nears first layer 9212-B and / or third layer 9216-B may be suitable to increase engagement of a material with board 9210-B.

[0441] Fig. 10A is a perspective view of a portion of an alternate board 9210-C. Fig. 10B is a cross-sectional view of a board 9210-C. Board 9210-C may have any or all of the characteristics of board 9210, 9210-A, and / or 9210-B, described above, except as described below. For example, board 9210-C may have a first layer 9212-C, a second layer 9214-C, and a third layer 9216-C. Each layer 9212-C, 9214-C, 9216-C of board 9210-C may have any or all of the characteristics of the respective layers 9212, 9214, 9216 of board 9210 and / or layers 9212-A, 9214-A, 9216-A of board 9210-A. For example, second layer 9214-C may be disposed between first layer 9212-B and third layer 9216-C. Second layer 9214-C may comprise a conductive, e.g., copper, material. First layer 9212-C and / or third layer 9216-C may comprise a polyimide material, or any other materials described above.

[0442] Board 9210-C may include one or more through holes 9228. Through hole(s) 9228 may extend through each of first layer 9212-C, second layer 9214-C, and third layer 9216-C. Through hole(s) 9228 may extend straight through each of first layer 9212-C, second layer 9214-C, and third layer 9216-C.

[0443] During the overmolding or bonding process, material may be flowed over board 9210-C and may flow through through hole(s) 9228. Once cured or otherwise set or hardened, the material located in through hole(s) 9228 may extend through second layer 9214-C and connect first layer 9212-C to third layer 9216-C. This connection of the material through through hole(s) 9228 may further secure the material to board 9210-C and create mechanical interlocking. The material passing through through hole(s) 9228 may act as an anchor when the material is being subjected to external forces that may otherwise cause peeling of the material off of board 9210-C.

[0444] Figs. 10C-10E illustrate alternative configurations of through hole(s) 9228. For example, Fig. 10C illustrates a through hole 9228-A having a frustoconical shape. Through hole 9228-A may have an inner surface 9230. Through hole 9228-A may be configured such that a width of through hole 9228-A on a first side of board 9210-C is smaller than a width of through hole 9228-A on a second side of board 9210-C.

[0445] Fig. 10D illustrates a through hole 9228-B having a funnel shape. For example, a width of a first portion 9232 of through hole 9228-B may be substantially straight, for example, through a first portion of board 9210-C. The first portion 9232 of through hole 9228-B may extend through board 9210-C a first depth. A second portion 9233 of through hole 9228-B may extend through board 9210-C a second depth. The first portion 9232 of through hole 9228-B may have a first width. The second portion 9233 of through hole 9228-B may have a second, increasing width. For example, the diameter of the second portion 9233 of through hole 9228-B may increase as the through hole extends from the first side of board 9210-C to the second side of board 9210-C.

[0446] Fig. 10E illustrates a through hole 9228-C having a T-shape. For example, a diameter of a first portion 9234 of through hole 9228-C may be substantially straight, for example, through a first portion of board 9210-C. The first portion 9234 of through hole 9228-C may extend through board 9210-C a first depth. A second portion 9235 of through hole 9228-C may extend through board 9210-C a second depth. The first portion9234 of through hole 9228-C may have a first width. The second portion 9235 of through hole 9228-C may have a second width. The first width may be smaller than the second width.

[0447] Through holes 9228, 9228-A, 9228-B, and / or 9228-C may extend through an entirety of board 9210-C. In some examples, a plurality of through holes 9228, 9228-A, 9228-B, and / or 9228-C may be disposed across board 9210-C in a pattern (e.g., a series of rows, columns, diagonals, etc.) or randomly. Alternatively, one or more discrete portions of board 9210-C may include through holes 9228, 9228-A, 9228-B, and / or 9228- C. For example, an outer perimeter of board 9210-C may include through holes 9228, 9228-A, 9228-B, and / or 9228-C, the corners of board 9210-C, and / or a central region of board 9210-C may include through holes 9228, 9228-A, 9228-B, 9228-C.

[0448] In yet other examples, the through hole(s) 9228-A, 9228-B, and / or 9228-C depicted in Figs. 10C-10E may extend through first layer 9212-C and / or third layer 9216- C, but not second layer 9214-C. For example, the wider portions of each of thru-holes 9228-A, 9228-B, and / or 9228-C may be positioned relatively closer to second layer 9214- C than the narrower portions of each of thru-holes 9228-A, 9228-B, and / or 9228-C, which may extend through the outer surfaces of first layer 9212-C and / or third layer 9216-C. The widening of thru-hole(s) 9228-A, 9228-B, and / or 9228-C in the inner portions of first layer 9212-C and / or third layer 9216-C may allow material flowed over board 9210-C during the overmolding or bonding process to flow into through hole(s) 9228-A, 9228-B, and / or 9228-C. Once cured or otherwise set or hardened, the material located in through hole(s) 9228-A, 9228-B, and / or 9228-C may have a widened lip or flange within an inner region of first layer 9212-C and / or third layer 9216-C that engages with first layer 9212-C and / or third layer 9216-C and may further secure the material to board 9210-C and create mechanical interlocking.

[0449] Each example discussed herein, e.g., in Figs. 7A through 10E, may be used alone or in combination with one or more techniques. For example, one or more of different materials or surface treatments (e.g., primers, adhesives, etching, etc.), features, through holes, etc., may be used alone or in conjunction with one another. Various combinations are contemplated, for example, to enhance or improve adhesion between board 9210 and component(s) of the respiratory therapy system 8000 (e.g., patientinterface 3000) or other materials that facilitate inclusion within respiratory therapy system 8000.

[0450] Fig. 11 illustrates an encapsulated chip 1200. For example, encapsulated chip 1200 includes a substrate 1202, a board (or chip) 1210, and a cap 1204. Board 1210 may have any or all of the characteristics of boards 9210, 9210-A, 9210-B and / or 9210-C, discussed above. Substrate 1202 and cap 1204 may encapsulate board 1210, for example, to form a liquid-tight seal.

[0451] Fig. 12 depicts a flow diagram of an exemplary method 1300 for forming encapsulated chip 1200. In a first step 1301, substrate 1202 may be formed, e.g. molded. For example, substrate 1202 may be injection-molded or otherwise formed. Substrate 1202 may be formed of a soft or flexible plastic, or silicone material. In some examples, substrate 1202 may be formed from a hard or rigid material. Substrate 1202 may be clear or transparent. In some examples, substrate 1202 may be colored and / or opaque.

[0452] In a second step 1302, board 1210 may be placed on substrate 1202. In some examples, board 1210 may be adhered to substrate 1202, for example, using an adhesive. Board 1210 may be placed on substrate 1202 such that a width of substrate 1202 is greater than a width of board 1210. For example, board 1210 may be placed in a central region of substrate 1202.

[0453] In a third step 1303, cap 1204 may be formed over board 1210 and / or substrate 1202, for example, to encapsulate board 1210 between substrate 1202 and cap 1204. Cap 1204 may be formed, for example, by overmolding an additional substrate over substrate 1202 and board 1210. In such a way, encapsulated chip 1200 is formed.

[0454] In a fourth step 1304, encapsulated chip 1200 may be coupled to a component of the respiratory therapy system 8000 (e.g., patient interface 3000 (for example a cushion), conduit tube 4170, etc.). For example, encapsulated chip 1200 may be bonded to or overmolded with the component. In some aspects, the entire component or a portion of a component may be overmolded with chip 1200 on it.

[0455] Either multiple-shot molding or insert molding may be used in the method 1300 described herein.

[0456] Fig. 13 illustrates an alternative configuration of an encapsulated chip 2200.In such a configuration, board, or chip 1210 may be placed on or coupled to a surface of acomponent 1206 of the respiratory therapy system 8000 (e.g., patient interface 3000, conduit tube 4170, etc.). For example, board 1210 may be placed on a cushion of patient interface 3000. In some aspects, board 1210 may have an adhesive backing, similar to a sticker, to allow board 1210 to be adhered to component 1206. Once board 1210 is placed on the surface of the component 1206, a UV adhesive glue or other suitable material may be applied over board 1210, for example, to encapsulate board 1210 and form encapsulated chip 2200. The UV adhesive may form a layer or a dome over board 1210, for example to seal board 1210 and bond board 1210 to the surface of the component.

[0457] Figs. 14A and 14B depict an exemplary patient interface 3000'. The patient interface 3000' may be used, for example, as the patient interface 3000 of the system 8000 described above with respect to Figs. 6. Fig. 14A is a front view of the patient interface 3000', and Fig. 14B is a side view of the patient interface 3000'. The patient interface 3000' may be commonly known as a nasal patient interface or a full-face patient interface. For example, the patient interface 3000' may be configured to cover a patient's mouth and nose, or just a patient's nose.

[0458] Figs. 14A and 14B include stippling to better illustrate and describe the various portions of the patient interface 3000' to be described herein. However, the stippling is for purposes of description and does not necessarily represent that the different portions of the patient interface 3000' include different materials, properties, or color, although in one example, the different portions may include different materials, properties, or colors.

[0459] The patient interface 3000' has a three-dimensional shape that may vary depending on the style or type of patient interface. For example, the size and shape of the patient interface 3000' may vary considerably from the size and shape depicted in FIGS. 14A and 14B. Portions of the patient interface 3000' may be formed of a rigid or hard material, and other portions of the patient interface 3000' may be formed of a soft or pliable material. Accordingly, the placement of an RFID tag, such as the tag 9200, on the patient interface 3000' poses unique considerations. Tag 9200 may be comprised of the board 9210, as discussed above.

[0460] The patient interface 3000' comprises a shell 3002 having a first portion 3002A, a second portion 3002B, a third portion 3002C, and a fourth portion 3002D. Oneor more portions of the shell 3002 (e.g., the first portion 3002A, the second portion 3002B, and the third portion 3002C) may be formed of a rigid material (e.g., polycarbonate) and may not contact the patient’s skin. One or more portions of the shell 3002 (e.g., fourth portion 3002D) may be formed of a softer, more pliable material (e.g., silicone rubber). First portion 3002A includes an opening 3008. The opening 3008 extends an entire thickness of the shell 3002 and is configured to directly or indirectly couple the patient interface 3000' to a proximal portion of the air circuit 4170. The opening 3008 is aligned with a median plane M of patient interface. The first portion 3002A surrounds the opening 3008. The second portion 3002B and the third portion 3002C surround the first portion 3002A.

[0461] Tag 9200 may be positioned near the opening 3008 in a “tube-down” configuration of the patient interface 3000', as shown in Fig. 14A (Figs. 5K and 5M also depict similar “tube down” configurations for which the tag 9200 may have a similar position). For example, the tag 9200 may be coupled to either the first portion 3002A, the second portion 3002B, the third portion 3002C, or the fourth portion 3002D. In some aspects, due to the proximity of the opening 3008, the tag 9200 may be placed on or near the third portion 3002C, which may be an ideal positioning for the patient interface 3000'. The third portion 3002C is near or adjacent to median plane M. For example, the tag 9200 may be placed to one side (i.e., a left or right side) defined by median plane M, or to the other side (i.e., a right or left side) defined by median plan M, or along median plan M. In some configurations, the tag 9200 may be positioned so as to straddle multiple portions of the patient interface 3000'. For example, a first portion of tag 9200 may be on first portion 3002A of the shell 3002 and a second portion of tag 9200 is on the second portion 3002B and / or the third portion 3002C of the shell 3002. In such a way, the placement of the tag 9200 may vary between the first portion 3002A, the second portion 3002B, the third portion 3002C and / or the fourth portion 3002D.

[0462] The tag 9200 may be placed on or in the shell 3002 through a variety of means. For example, the tag 9200 may be a chip 9210 overmolded into the shell 3002, as discussed above. Alternatively, the tag 9200 may be printed directly on the shell 3002 via printed conductive material, e.g., silver ink. The tag 9200 may be an inlay label overmolded into shell 3002. In such an example, the tag 9200 (e.g., the inlay label) maybe inserted, e.g., via automation into a cavity of a mold for the shell 3002, and an injection mold and plastic may be injected over the inlay label, thus fixing inlay label within or on the shell 3002. Alternatively, the tag 9200 may be formed of conductive silicone and / or conductive threads printed on the shell 3002. In further alternatives, the tag 9200 may be formed of a conductive textile with stretchable copper traces. Accordingly, the tag 9200 may be formed by any one of these methods or by any combination of these methods, including those commonly known in the art. Further still, the tag 9200 may be an individual component fixed to the shell 3002 through a variety of suitable means commonly known in the art, including, but not limited to adhesives, and / or one or more mechanical fasteners.

[0463] The patient interface 3000' further comprises a cushion 3006 configured to contact the patient's face. The cushion 3006 may be formed of a soft or pliable material, for example, silicone rubber. The cushion 3006 is configured to form a seal against the patient's face. Although the tag 9200 may be placed on or within the cushion 3006, placing the tag 9200 on or within the cushion 3006 may be less desirable due to challenges associated with the distance of cushion 3006 from the opening 3008 and / or challenges associated with one or more characteristics of the material comprising the cushion 3006 (e.g., the material's flexibility, softness, thickness, etc.). Additionally or alternatively, placing the tag 9200 on or within the cushion 3006, for example, between the patient's skin and the cushion 3006 may result in patient discomfort. That said, it may be possible to locate the tag 9200 in the cushion 3006.

[0464] Although Figs. 14A and 14B depict a tube-down patient interface 3000' and discuss location of the tag 9200 near the opening 3008, a tube-up patient interface may also be used according to this technology. In a tube-up patient interface 3000', the location of the tag 9200 may be, for example, located closer to an upper region of the patient interface 3000'. In some aspects, the location of the tag 9200 on the patient interface 3000' may, at least in part, depend on whether a tube-up or tube-down configuration is utilized with the patient interface 3000' so as to position the tag 9200 to be closer to the proximal portion of the air circuit 4170 and the antenna 9100 when attached to the patient interface 3000'.

[0465] Figs. 15A and 15B depict an alternative exemplary patient interface 3000". The patient interface 3000" may be used, for example, with the system 8000 described above with respect to Figs. 6. Fig. 15 A illustrates a back view of the patient interface 3000", and Fig. 15B illustrates a top view of the patient interface 3000". The patient interface 3000' may be commonly known as a nasal pillow. For example, the patient interface 3000" may be configured to be partially inserted into a patient's nose.

[0466] Figs. 15 A and 15B include stippling to better illustrate and describe the various portions of the patient interface 3000" to be described herein. However, the stippling is for purposes of description and does not necessarily represent that the different portions of the patient interface 3000" include different materials, properties, or color, although in one example, the different portions may include different materials, properties, or colors.

[0467] The patient interface 3000" has a complex three-dimensional shape. For example, the patient interface 3000" includes a variety of curves and contours. Portions of the patient interface 3000" may be formed of a soft or pliable material, and other portions of the patient interface 3000" may be formed of hard or rigid material. For example, portions of the patient interface 3000" contacting the patient's face may be soft or pliable, and portions used to facilitate a connection between the air circuit 4170 and the patient interface 3000" may be hard, or rigid. Additionally, the patient interface 3000" is smaller in size as compared to the patient interface 3000', described above. Accordingly, the placement of the tag 9200, on the patient interface 3000" poses unique considerations.

[0468] The patient interface 3000" includes a first nasal cushion 3012A and a second nasal cushion 3012B on either side of a median plane M. For example, the first nasal cushion 3012A is on a first (e.g., left or right side) or median plane M, and second nasal cushion is on a second (e.g., right or left side) of median plane M. The first nasal cushion 3012A and second nasal cushion 3012B are configured to be at least partially inserted into the patient's nostrils and are thus skin-contacting. Accordingly, the material comprising first nasal cushion 3012A and second nasal cushion 3012B may be soft and pliable (e.g., silicone rubber). Additionally, the first nasal cushion 3012A and the second nasal cushion 3012B include a first hole 3014A and a second hole 3014B, respectively,extending through an entire thickness of the first nasal cushion 3012A and the second nasal cushion 3012B such that the first nasal cushion 3012A and the second nasal cushion 3012B are in fluid connection with a lumen 3016 of tubular portion 3018. The lumen 3016 extends through the tubular portion 3018, for example, from a first side 3020A of the tubular portion 3018 to a second side 3020B of the tubular portion 3018. The tubular portion 3018 includes a first portion 3018A, a second portion 3018B, and a third portion 3018C.

[0469] The first nasal cushion 3012A and the second nasal cushion 3012B extend radially outward from the first portion 3018A. The first portion 3018A may be comprised of the same material as the first nasal cushion 3012A and second nasal cushion 3012B or of a different material. The first nasal cushion 3012A and the second nasal cushion 3012B are configured to form a seal between the patient's skin.

[0470] The second portion 3018B is on either side of the first portion 3018A. For example, the second portion 3018B is to the left and to the right of the first portion 3018 A. The second portion 3018B may be comprised of the same material as the first portion 3018A or comprised of a different material. The second portion 3018B is not configured to form a seal with the patient’s skin and may not be configured to contact the patient’s skin.

[0471] The third portion 3018C is located on the outer sides of each second portion 3018B. For example, the third portion 3018C is to the left of the first portion 3018A and to the right of the second portion 3018B. The third portion 3018C comprises the first side 3020A and the second side 3020B. The third portion 3018C may not be configured to contact the patient’s skin. Accordingly, the third portion 3018C may be comprised of a harder or more rigid material. In a tube-down patient interface 3000", the air circuit 4170 may connect to patient interface 3000" at the first portion 3018 A, generally opposite the first nasal cushion 3012A and the second nasal cushion 3012B. Alternatively, in a tube- up patient interface 3000", the air circuit 4170 may attach to conduit headgear, which may attach to the third portions 3018C. In some aspects, the location of tag 9200 on patient interface 3000" may, at least in part, depend on whether a tube-up or tube-down configuration is utilized with patient interface 3000" so as to position tag 9200 to becloser to the proximal portion of air circuit 4170 and antenna 9100 when attached to patient interface 3000".

[0472] In utilizing the patient interface 3000", the air circuit 4170 with the antenna 9100 may be connected to the patient interface 3000". The tag 9200 may be positioned near the connection site of the air circuit 4170. For example, the tag 9200 may be coupled to the first portion 3018A, the second portion 3018B, or the third portion 3018C. In some aspects, in order to avoid contact with a patient’s skin, the tag 9200 may be coupled to the second portion 3018B or the third portion 3018C. In some configurations, the tag 9200 may be positioned so as to straddle multiple portions of the patient interface 3000'. For example, a first portion of the tag 9200 may be on the second portion 3018B, and a second portion of the tag 9200 may be on the third portion 3018C. In such a way, the placement of the tag 9200 may vary between the first portion 3018 A, the second portion 3018B, and the third portion 3018C.

[0473] Placing the tag 9200 on or within the first nasal cushion 3012A, the second nasal cushion 3012B, and / or, in some aspects, the first portion 3018A may be less desirable due to challenges associated with contact with a patient’s skin. Additional or alternative challenges may be associated with one or more characteristics of the material comprising first nasal cushion 3012A and the second nasal cushion 3012B (e.g., the material’s flexibility, softness, thickness, etc.). Additionally or alternatively, placing the tag 9200 on or within the first nasal cushion 3012A and the second nasal cushion 3012B, for example, between the patient's skin and first nasal cushion 3012A or the second nasal cushion 3012B, may result in patient discomfort.

[0474] The tag 9200 may be placed on or in the patient interface 3000" through a variety of means, similar to those discussed above with fixing the tag 9200 to the patient interface 3000'. For example, the tag 9200 may be a chip overmolded within the tubular portion 3018, as discussed above. Alternatively, the tag 9200 may be printed directly onto the tubular portion 3018 via printed conductive, e.g., silver, ink. The tag 9200 may be an inlay label overmolded within the tubular portion 3018. In such an example, the tag 9200 (e.g., the inlay label) may be inserted, e.g., via automation into a cavity of a mold for the tubular portion 3018 and an injection mold and plastic may be injected over the inlay label, thus fixing the inlay label within or on the tubular portion 3018. Alternatively, thetag 9200 may be formed of conductive silicone and / or conductive threads printed on the tubular portion 3018. In further alternatives, the tag 9200 may be formed of a conductive textile with stretchable conductive, e.g., copper, traces. Accordingly, the tag 9200 may be formed by any one of these methods or by any combination of these methods, including those commonly known in the art. Further still, the tag 9200 may be an individual component fixed to the tubular portion 3018 through a variety of suitable means commonly known in the art, including, but not limited to adhesives, and / or one or more mechanical fasteners.

[0475] During use of the patient interfaces 3000, 3000', 3000", or another suitable patient interface (collectively patient interface 3000), the air circuit 4170 may be fluidly coupled to the RPT device 4000 and to the patient interface 3000. As described above, the RPT device 4000 may be configured to supply a flow of gas, for example, air, which may be supplemented with oxygen, through the air circuit 4170 to the patient interface 3000. The RPT device 4000 may also be configured to receive a signal from RFID system 9000 once air circuit 4170 is coupled to patient interface 3000 (e.g., via the data communication interface 4280 and / or the central controller 4230). The signal may include information regarding patient interface 3000 or an accessory. For example, the antenna 9100 in the air circuit 4170 or the adapter 9400 may the detect tag 9200 in the patient interface 3000 and may read information about the patient interface 3000 associated with the tag 9200. Via the transceiver 9300, for example, this information may be transmitted to the RPT device 4000 (e.g., to the data communication interface 4280).

[0476] In some aspects, the received information may be one or more of e.g., the type of the patient interface 3000 being used, characteristics of the patient interface 3000 (e.g., one or more of cushion material, cushion size, conduit size, patient interface size, length of use of the patient interface, date of manufacture of the patient interface, a set of respiratory therapy conditions the patient interface is suitable for use with, etc.), date of usage or time stamp, batch identification number of the patient interface 3000, or a serial identification number of the patient interface 3000. In some aspects, the received information may be one or more of patient information, e.g., the type of therapy or therapy settings the patient is intended to receive, or other information. In some aspects,the received information may be whether the air circuit 4170 and / or an accessory device (not shown) is connected or disconnected from the patient interface 3000.

[0477] The RPT device 4000 may be configured to perform an action upon receiving information from the RFID system 9000 about the patient interface 3000. To facilitate the description herein, RPT the device 4000 may be described as performing an action based on receipt of information, however, this may mean either that a controller incorporated as part of the RPT device 4000 (e.g., the central controller 4230 and / or the therapy control module 4330) may cause RPT device to perform an action or a controller separate from the RPT device 4000 may cause the RPT device 4000 to perform an action. For example, the RPT device 4000 may automatically control operation of the therapy provided to the patient based on the information or signal received (e.g., via the central controller 4230 and / or the therapy control module 4330, as discussed above). For example, the breathing experience may be improved by determining whether the settings of the RPT device (e.g., gas flow, humidity levels, etc.) are correctly aligned to the patient interface being worn by the patient. In some configurations, the RPT device 4000 may enable the design of patient interface-specific venting and flow curves to promote more comfortable and / or efficient delivery of therapy. In some aspects of the technology, an indication to the patient may be generated based on the information received by the RPT device 4000. For example, an indication may be generated that the incorrect type or size of patient interface is being used, that a cushion of the patient interface or the entire patient interface should be replaced, that the RPT device 4000 is configured with one or more incorrect settings that should be changed by the patient, or other suitable indications. The indication may be generated, e.g., on one or more of a display of the RPT device 4000 or other component of the system 8000, to an external device, such as the remote external device 4286 or the local external device 4288 (e.g., a patient’s tablet, smartphone, or computer, or a device of a healthcare provider). In other aspects, the respiratory therapy system 8000 may receive input from a patient, for example, a patient may input information regarding the patient interface 3000 during a therapy session, and the received input from the patient may be compared with the information received from the patient interface 3000 in the RFID system 9000 to confirm the accuracy of a patient’ sinput. In some aspects, information received from the RFID system 9000 may be used to track usage or other characteristics of the patient interface in use.

[0478] In further aspects of the technology, information received from the patient interface 3000 may be received by the RPT device 4000 in addition to information received from other sensors or systems associated with the system 8000. For example, sensors or systems configured to detect air flow, pressure, air leaks, humidity, or other characteristics of the system 8000 may transmit information to the RPT device 4000. The RPT device 4000 may analyse or interpret information regarding the patient interface 3000 received from the RFID system 9000 in combination with one or more other sensors. For example, information may be received from the RFID system 9000 regarding the type or size of patient interface being worn or how long the patient interface has been used for. The system 8000 may also receive information from other sensors or patient input regarding patient interface discomfort or the occurrence of leaks.

[0479] The system 8000 may analyse this information together and may take an action based on the aggregate information. For example, if patient interface discomfort is indicated by a patient or leaks are detected with the patient interface, based on the information received from the RFID system 9000, the RPT device 4000 may generate an indication to a patient that a difference size or type of patient interface should be used, a different size or type of cushion should be used, or a new patient interface or cushion should be used. This indication may include, e.g., a suggestion regarding a patient interface or cushion type or size to be used or guidance on how to select a better-fitting cushion or patient interface type or size. Indications may be generated as described above, e.g., on one or more of a display of the RPT device 4000 (e.g., the display 4294) or other component of the system 8000, to an external device, such as the remote external device 4286 or the local external device 4288 (e.g., a patient’s tablet, smartphone, or computer, or a device of a healthcare provider). In other aspects, one or more settings of the RPT device 4000 may be changed based on the aggregate information received from the RFID system 9000 and other information from system 8000. In some aspects, the indication may be that the air circuit 4170 is not coupled to the patient interface 3000 or is improperly coupled to the patient interface 3000.

[0480] In some aspects, the system 8000 may indicate to a patient when a patient interface or cushion has been worn long enough or is an old enough production batch identification number or a serial identification number that performance may be impacted and a new patient interface or cushion should be used. In some aspects, the age of the patient interface or how many times the patient interface has been used may lead to generation of an indicator that a new patient interface or new cushion should be used. The system 8000 may indicate a patient to replace the patient interface or cushion. This indication may also depend, at least in part, on the recommended usage period of a particular patient interface or cushion type, the type of therapy being administered to the patient, or one or more other factors. Indications may be generated as described above, e.g., on one or more of a display of the RPT device 4000 (e.g., the display 4294) or other component of the system 8000, to an external device, such as the remote external device 4286 or the local external device 4288 (e.g., a patient’s tablet, smartphone, or computer, or a device of a healthcare provider), or to a cloud server, such as remote external communication network 4282 and / or local external communication network 4284 and / or remote external communication network 4282 (e.g., for remote monitoring, to improve patient experience, to trigger an order (such as for a new patient interface or accessory, etc.)).

[0481] The antenna 9100 and the transceiver 9300 may read a signal from the tag 9200 at least once during a therapy session. For example, the tag 9200 may be read when therapy starts, e.g., when a start button is pressed or when auto-start is initiated. In some aspects, if no accessory or the air circuit 4170 is detected as being attached to a patient interface 3000, then the RFID system 9000 may continue to read, e.g., continuously or at regular intervals. In some configurations of the technology, a signal from the tag 9200 may be read periodically, e.g., at every few seconds, minutes, or hours. In some examples of the technology, the antenna 9100 and the transceiver 9300 may read the signal from the tag 9200 according to a regular or irregular frequency. For example, the signal may be read more or less frequently at the beginning of a session or after a pre-determined amount of time. In some aspects, the frequency may increase if an unexpected reading occurs, or in the event of a failed reading. In some aspects, the type of therapy beingadministered or type of patient interface being used may at least in part determine the frequency with which the tag 9200 is read.

[0482] Fig. 16A illustrates a perspective cross-sectional view of a portion of a headgear tube 3350' configured to deliver pressurised air received from a conduit forming part of the air circuit 4170. Fig. 16B illustrates a cross-sectional view of headgear tube 3350'. Headgear tube 3350' may be used with a nose and mouth face mask and / or a nasal- only mask, either in the tube up or tube down configuration. For example, headgear tube 3350' may be used with any suitable patient interface 3000', described above. A wall 3007 of headgear tube 3350' may be formed of a soft or pliable material, for example, silicone rubber. Headgear tube 3350' may be hollow. During use, a first lumen 3008 of headgear tube 3350' may convey a fluid (e.g., a gas or air) to a user. A cross-sectional shape of headgear tube 3350' may vary. For example, headgear tube 3350' may have a substantially oval cross-section, circular cross-section, etc.

[0483] An internal surface 3007A of wall 3007 may define first lumen 3008. An external surface 3007B may include a pair of arms 3009 extending radially outward from external surface 3007B and towards one another. Arms 3009A, 3009B may extend an entire length of headgear tube 3350' (as also shown in Figs. 18-20). In some examples, arms 3009 may extend less than an entire length of headgear tube 3350', e.g., for one or more discrete lengths on headgear tube 3350'. A first arm 3009A may extend outward from external surface 3009B and towards a second arm 3009B. Second arm 3009B may extend outward from external surface 3007B and towards first arm 3009A. Each of arms 3009A, 3009B may be bendable. Each arm 3009A, 3009B may have a respective free end 3011A, 301 IB. Similarly, each arm may have a respective fixed end 3012A, 3012B fixed to external surface 3007B. For example, first arm 3009A may include fixed end 3012A and free end 3011 A, and second arm 3009B may include fixed end 3012B have a free end 301 IB. Free ends 3011A, 301 IB of each respective arm 3009A, 3009B may meet, or touch, to form a second lumen 3010. In some examples, free ends 3011 A, 301 IB may be glued or otherwise bonded together, for example, such that second lumen 3010 is closed or sealed.

[0484] In some examples, free ends 3011A, 301 IB of each respective arm 3009A, 3009B may not meet. For example, a channel 3013 may be formed between each of firstarm 3009A and second arm 3009B. In some examples, channel 3013 may be filled with a material (e.g., an adhesive, epoxy, silicone, etc.) to seal or close lumen 3010.

[0485] A device 3014 may extend through second lumen 3010. Device 3014 may be, for example, cabling associated with antenna 9100 and / or tag 9200. Device 3014 may alternatively be the antenna 9100 and / or tag 9200. Device 3014 may be fixed within second lumen 3010 or may be loosely disposed within second lumen 3010. For example, in some aspects, an epoxy, silicone, and / or adhesive may fill second lumen 3010 to fixed device 3014 in place within second lumen 3010.

[0486] Fig. 17A illustrates a perspective cross-sectional view of a portion of an alternative headgear tube 3350". Fig. 17B illustrates a cross-sectional view of headgear tube 3350". Headgear tube 3350" may be used with a nasal and mouth mask and / or a nasal-only mask. Headgear tube 3350' may have any or all of the characteristics of headgear tube 3350', except as described below. For example, headgear tube 3350" may be used with patient interface 3000', described above. A wall 3007' of headgear tube 3350" may be formed of a soft or pliable material, for example, silicone rubber.

[0487] An internal surface 3007 A' of wall 3007' may define first lumen 3008'. An external surface 3007B' may include single arm 3009' extending radially outward from external surface 3007B’. Arm 3009' may be flexible, or bendable. Arm 3009' may extend an entire length of headgear tube 3350". In some examples, arm 3009' may extend less than an entire length of headgear tube 3350", e.g., for one or more discrete lengths on headgear tube 3350". Arm 3009' may have a free end 3011A' and a fixed end 3012'.Fixed end 3012' may be fixed to external surface 3007B'.

[0488] Arm 3009' may bend such that free end 3011' touches, or abuts, external surface 3007B to form second lumen 3010'. In some examples, free end 3011' may be glued or otherwise bonded to external surface 3007B', for example, such that second lumen 3010' is closed or sealed. In some examples, free end 3011' may be adhered to external surface 3007B', for example, with an adhesive, epoxy, silicone, etc., to seal or close second lumen 3010'.

[0489] A device 3014’may extend through second lumen 3010'. Device 3014' may have any of the characteristics of device 3014. For example, device 3014' may be a wire, a cable, an electrical connection, antenna 9100, and / or tag 9200. Device 3014' may befixed within second lumen 3010' or may be loosely disposed within second lumen 3010'. For example, an epoxy, silicone, and / or adhesive may fill second lumen 3010' to fixed device 3014' in place within second lumen 3010'.

[0490] One or more aspects of Figs. 16A, 16B, 17A, and / or 17B may be incorporated with additional or alternative components of respiratory therapy system 8000. For example, the pair of arms 3009A, 3009B and lumen 3010 of Fig. 16A, 16B and / or the arm 3009' and lumen 3010' of Fig. 17A, 17B may be incorporated on or in any of the patient interfaces previously discussed (e.g., patient interface 3000, 3000', 3000", 3000-1, 3000-2, 3000-3, 3000-4). For example, the pair of arms 3009 or arm 3009' may extend radially outward from a surface of the patient interface. In some examples, the pair of arms 3009 or arm 3009' may be incorporated on or in a cushion of any of the patient interfaces previously discussed. In such a way, the pair of arms 3009 or arm 3009' may be utilized, for example, to manage one or more wires, cables, or electrical connections (e.g., device 3014, 3014') associated with antenna 9100 and / or tag 9200. Additionally or alternatively, the pair of arms 3009 or arm 3009' may be utilized to couple, or fix, one or more wires, cables, electrical connections, antenna 9100, or tag 9200 to the patient interface (e.g., to cushion and / or to a surface of the patient interface). Additionally or alternatively, the pair of arms 3009A, 3009B and lumen 3010 of Fig. 16A, 16B and / or the arm 3009' and lumen 3010' of Fig. 17A, 17B may be incorporated on or in an air circuit 4170.

[0491] Fig. 18 illustrates an example of the technology described herein in the context of an exemplary tube -up patient interface. As previously discussed, the respiratory therapy system 8000 may be configured to wirelessly detect the identification of a patient interface 3000 or an accessory that a patient is using during a therapy session. In particular, the respiratory therapy system 8000 may be configured for use with a tube- up patient interface, such as patient interface 3000- 1 of Fig. 5 J or patient interface 3000-3 of Fig. 5L, e.g., a full-face, nasal, or pillow cushion tube-up patient interface.

[0492] The tube-up patient interface 3000' may include one or more Radio Frequency Identification (RFID) tags and / or antennas incorporated on or within the patient interface 3000'. For example, an RFID tag and / or an antenna may be incorporated with one or more of a pillow cushion or other seal-forming structure 3100 of patientinterface 3000', a conduit of the patient interface 3000' (such as the headgear tubes 3350), or near a connection point with an air circuit. The RFID tag and / or antenna may be incorporated on or in patient interface 3000' (or other components of respiratory therapy system 8000, as previously discussed) using any of the methods or devices discussed herein.

[0493] Aspects of the technology described herein may relate to the inclusion of an extended tag and / or antenna portions within a tube -up patient interface having stretchable portions, e.g., corrugated concertina portions such as the extendable concertina structure 3362, described above. For example, stretchable portions of an extended tag and / or antenna may be used, for example, in order to facilitate communication between the RFID tag, antenna, and / or transceiver. Although the technology disclosed in this section is discussed in regards to a tube -up configuration, the technology may also be used with tube-down configurations (such as patient interfaces 3000-2 of Fig. 5K or 3000-4 of Fig. 5M).

[0494] In one example, in reference to Fig. 18, a first tag 9200A may be associated with the conduit headgear 4180 and may be configured to store identifying data of the conduit headgear 4180. The second tag 9200B may be associated with the patient interface 3000' or a cushion of the patient interface 3000' and may be configured to store identifying data of patient interface 3000' and / or a cushion of the patient interface 3000'. Upon connecting the air circuit 4170 to the conduit headgear 4180, the first antenna 9100 A may detect the first tag 9200 A and receive the identifying data of the conduit headgear 4180. The third antenna 9100C may detect second tag 9200B and receive the identifying data of the patient interface 3000' or a cushion of the patient interface 3000', which may then be transmitted along an electrical connection 9105, which may include a flexible printed circuit board to second antenna 9100B. The first antenna 9100A may then read the data from the second antenna 9100B. Although two tags 9200 are depicted in the accompanying figures, only one tag 9200 may be incorporated in RFID system 9000 in some aspects. In other aspects, more than two tags, e.g., three, four, five, or more tags, may be incorporated in the RFID system 9000.

[0495] Any of the tags 9200 and / or antenna 9100 may described in reference to Fig. 18 may include a flexible printed circuit board. In some embodiments, the first tag 9200 Amay include an adhesive, a primer, or may otherwise be configured, for example, to facilitate adhesion to conduit headgear 4180 and / or to maintain the first tag 9200A in place on the conduit headgear 4180 after application. In some aspects, the first tag 9200A may be overmolded to or overmolded within or integrally formed on a portion of the conduit headgear 4180, as discussed above. For example, first tag 9200 A including a flexible printed circuit board may be overmolded to a silicone conduit headgear 4180 using any of the approaches described above, such as using one or more of features 9220, through holes 9228, encapsulation, adhesives, primers, selection of materials, surface treatment, etc.

[0496] Similarly, the second tag 9200B may include an adhesive, a primer, or may otherwise be configured, for example, to facilitate adhesion to patient interface 3000', and / or to maintain the second tag 9200B in place on the patient interface 3000' (or the cushion) after application. The second tag 9200B may alternatively be overmolded to or overmolded within or integrally formed on a portion of the patient interface 3000', as discussed above. For example, second tag 9200B including a flexible printed circuit board may be overmolded to a silicone portion of patient interface 3000' using any of the approaches described above, such as using one or more of features 9220, through holes 9228, encapsulation, adhesives, primers, selection of materials, surface treatment, etc.

[0497] The RFID system 9000 may include one first tag 9200A fixedly or removably coupled to the conduit headgear 4180 and / or one second tag 9200B fixedly or removably coupled to the patient interface 3000' or to an accessory device (not shown).Alternatively, the RFID system 9000 may include two or more first tags 9200A fixedly or removably coupled to the conduit headgear 4180 and / or two or more second tags 9200B fixedly coupled to the patient interface 3000 or to an accessory device (not shown). The first tag 9200A and / or the second tag 9200B described herein may be off-the-shelf components or may be customized according to a size and / or a shape of the patient interface 3000 or the conduit headgear 4180 and / or according to a desired read range for the first tag 9200 A and the second tag 9200B.

[0498] The first antenna 9100 A may be configured to receive data from the second antenna 9100B and the first tag 9200A. The first antenna 9100A is also configured to transmit the data received from the second antenna 9100B and the first tag 9200 A totransceiver, or the reader, 9300 (shown in Fig. 6). The transceiver 9300 may be operably connected to the first antenna 9100A, e.g., physically (via a wire) and may be located on the air circuit 4170. In one configuration, a transceiver 9300 may be external to the respiratory therapy system 8000. For example, the transceiver 9300 may be a scanner, a smartphone, a tablet, or any other device configured to receive transmitted RFID signals from an RFID tag or antenna. Accordingly, the first antenna 9100 A is configured to communicate data received from one or more tags 9200 to the transceiver 9300. The transceiver 9300 may also be configured to save or store the transmitted data from the first antenna 9100A.

[0499] The transceiver 9300 may relay information from the first antenna 9100A to a controller configured to control the RPT device 4000 (e.g., the central controller 4230 and / or the therapy control module 4330). The controller may be separate from the RPT device 4000 or may be incorporated as part of the RPT device 4000. The controller may function as described above. In some configurations, the transceiver 9300 may be configured to transmit data to the RPT device 4000 physically (e.g., via a wire) or wirelessly. The RPT device 4000 may also be configured to save or store the transmitted data from the transceiver 9300, interpret the transmitted data, and / or transmit an alert or signal to the user or care provider, as described above. In some embodiments, RPT device 4000 may also be configured to automatically change one or more characteristics of the respiratory pressure therapy, for example, based on the raw data and / or interpreted data received from the transceiver 9300. Additionally or alternatively, the RPT device 4000 may be configured to suggest one or more therapy settings, for example, to promote patient care and / or patient comfort based on the interpreted data from the transceiver 9300, as will be discussed further below.

[0500] Although not shown in Fig. 18, the transceiver 9300 may be a combined with the first antenna 9100A. For example, the transceiver 9300 and the first antenna 9100A may form a single combined component. The combined component may 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 may be configured to send or receive data to a controller e.g., of the RPT device 4000, such as the central controller 4230.

[0501] Fig. 18 illustrates a perspective view an exemplary patient interface 3000' and the conduit headgear 4180. The patient interface 3000' may be used with the system 8000, described above. The conduit headgear 4180 is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components of a respiratory therapy system such as, for example, air circuit 4170 and patient interface 3000'.

[0502] A proximal portion 4170A of the air circuit 4170 may be coupled to a second portion 4180B of the conduit headgear 4180. The air circuit 4170 may be coupled to the conduit headgear 4180 via, for example, a joint 4190. The joint 4190 may permit rotation and movement of the air circuit 4170 while still maintaining a connection between the air circuit 4170 and the conduit headgear 4180. In alternative embodiments, the air circuit 4170 is coupled directly to the conduit headgear 4180.

[0503] The conduit headgear 4180 may bifurcate or branch into a first portion 4180A and a second portion 4180B. A distal portion of the first portion 4180 A of the conduit headgear 4180 may include a flexible or stretchable portion, such as a first concertina portion 4200A, and the second portion 4180B of conduit headgear 4180 may include a flexible or stretchable portion, such as a second concertina portion 4200B. The first concertina portion 4200A and the second concertina portion 4200B may be the substantially the same for the purposes of this description. For example, the first concertina portion 4200 A may extend a first length along the first portion 4180A of the conduit headgear 4180, and the second concertina portion 4200B may extend the same length along second portion 4180B of the conduit headgear 4180. Each of the first concertina portion 4200A and the second concertina portion 4200B may be corrugated. Accordingly, the first concertina portion 4200A and / or the second concertina portion 4200B may extend and / or compress, for example, to adjust the conduit headgear 4180 to a patient's face. The first concertina portion 4200A and / or the second concertina portion 4200B may extend along an entire length of the conduit headgear 4180 or may extend along less than an entire length of the conduit headgear 4180, e.g., along a majority of a length of the conduit headgear 4180, or less than a majority of a length of conduit headgear 4180.

[0504] It may be challenging to incorporate a wire extending along the conduit headgear 4180 (e.g., between two or more antennas 9100 and / or tags 9200), for example,as a result of the flexibility and stretchability of the conduit headgear 4180. In particular, it may be difficult for the electrical connection 9105, which may include a flexible printed circuit board, to be bonded on or within the conduit headgear 4180 as a result of the material comprising conduit headgear 4180 (e.g., silicone), and / or as a result of the corrugated features of first concertina portion 4200A and / or the second concertina portion 4200B. In some examples, the electrical connection 9105 may need to maintain the correct antenna impedance while being stretchable. One or more of these challenges may be addressed by aspects of the technology described herein. For example, the antenna and / or electrical connection 9105 including a flexible printed circuit board may be overmolded to a silicone portion of patient interface 3000' using any of the approaches described above, such as using one or more of features 9220, through holes 9228, encapsulation, adhesives, primers, selection of materials, surface treatment, etc. In some examples, electrical connection 9105 may be comprised of one or more flexible materials (e.g., polyimide or another amorphous plastic, TPU, PET, and / or a silicone film).

[0505] In some examples, the first antenna 9100A may be disposed on or within a proximal portion 4170A of air circuit 4170. The second antenna 9100B may be disposed on or within a distal portion of the conduit headgear 4180 configured to couple to the air circuit 4170. The first tag 9200A may be adjacent to or near the first antenna 9100A, for example, within the second portion 4180B of the conduit headgear 4180. A distal end of the electrical connection 9105 is coupled to the second antenna 9100B. The electrical connection 9105 may extend from the second antenna 9100B, on or within a distal portion of the first portion 4180A of the conduit headgear 4180 to a proximal portion of the first portion 4180A. The electrical connection 9105 may be external of the conduit headgear 4180 or may extend within the material comprising the conduit headgear 4180 or within a coating applied to the conduit headgear 4180. As discussed above, first antenna 9100A, electrical connection 9105, and / or second antenna 9100B may be overmolded, e.g., to a silicone conduit headgear 4180 using any of the techniques described herein.

[0506] As described above with respect to Figs. 16A, 16B, 17A, and 17B, conduit headgear 4180 may include one or more arms extending radially outward from a surface of conduit headgear 4180 to form a second lumen. For example, an entire length or one ormore discrete lengths of conduit headgear 4180 may include a pair of arms (e.g., similar to the pair of arms 3009 discussed above with respect to Figs. 16A and 16B). The pair of arms of conduit headgear 4180 may form a second lumen, for example, similar to second lumen 3010 of Figs. 16A and 16B. In some examples, electrical connection 9105 may be disposed within the second lumen of conduit headgear 4180. Alternatively, an entire length or one or more discrete lengths of conduit headgear 4180 may include a single arm (e.g., similar to the single arm 3009' discussed above with respect to Figs. 17A and 17B). The single arm of conduit headgear 4180 may form a second lumen, for example, similar to second lumen 3010' of Figs. 17A and 17B. In some examples, electrical connection 9105 may be disposed within the second lumen of conduit headgear 4180. In such a way, the electrical connection 9105 may not be positioned within an air flow passage of the conduit headgear 4180.

[0507] In some examples, a proximal end of the electrical connection(s) 9105 is coupled to the third antenna 9100C. The third antenna 9100C is disposed on or within a proximal portion of the air circuit 4170, for example, within a proximal portion of the first portion 4180A of the conduit headgear 4180. A proximal end of the first portion 4180A of conduit headgear 4180 may be coupled directly or indirectly to the patient interface 3000'. The second tag 9200B may be associated with the patient interface 3000', a cushion, or one or more other accessories. Although the electrical connection 9105 and the third antenna 9100C are depicted in reference to the first portion 4180 A, the second portion 4180B may also incorporate similar structures and conduit headgear may be substantially symmetrical. In some aspects, however, one of the first portion 4180A or the second portion 4180B may incorporate the third antenna 9100C and the electrical connection 9105, while the other of the first portion 4180 A or the second portion 4180B may not.

[0508] In one aspect, to accommodate the stretchability of flexibility of the first concertina portion 4200 A and the second concertina portion 4200B, the electrical connection 9105 may extend along a serpentine path. As shown in Fig. 18, the electrical connection 9105 forms a plurality of the curves 9106. The plurality of curves 9106 may extend along a portion of the electrical connection 9105 or along an entirety of theelectrical connection 9105. For example, the plurality of curves 9106 may extend along at least the first concertina portion 4200A.

[0509] Each curve of the plurality of curves 9106 may be dimensionally the same or similar. Alternatively, one or more curves of the plurality of curves 9106 may dimensionally differ. For example, one or more curves of the plurality of curves 9106 may be larger or small to accommodate the curvature of the conduit headgear 4180 or changes in corrugation of the concertina portion. By arranging the electrical connection 9105 with the plurality of curves 9106 or, for example, in a zig-zag or serpentine path, stretching or bending of the conduit headgear 4180 may result in relatively little increase in tensile forces on the electrical connection 9105. This configuration may also reduce the chances of the electrical connection 9105 failing due to repeated stretching and / or bending cycles.

[0510] In another aspect, the electrical connection 9105 may itself have a coiled or serpentine configuration to allow for stretchability. An electrical connection 9105 with 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 zig-zag path. The electrical connection 9105 itself may or may not be formed of a stretchable material.

[0511] In another example, the electrical connection 9105 may be integrated within the material comprising the conduit headgear 4180. For example, electrical connection 9105 may be overmolded or otherwise formed with conduit headgear 4180. In such a way, electrical connection 9105 may be comprised of one or more flexible materials (e.g., polyimide or another amorphous plastic, TPU, PET, and / or a silicone film). For example, electrical connection 9105 may be formed as an extended flexible printed circuit board comprising at least three layers. For example, electrical connection 9105, and each layer thereof, may have any or all of the characteristics discussed above with respect to Figs. 7A, 7B, 8A-8C, 9A-9C, 10A-10E, and / or 11. Electrical connection 9105 may include any or all of the characteristics discussed above so as to improve adhesion of electrical connection 9105 on or within conduit headgear 4180 and / or sleeve 9107. Incorporating any or all of the characteristics discussed above with respect to Figs. 7A, 7B, 8A-8C, 9A- 9C, 10A-10E, and / or 11 with electrical connection 9105 may, for example, improve adhesion of electrical connection 9105 on or within conduit headgear 4180.

[0512] In some aspects, the electrical connection 9105 may be formed of a flexible conductive material, such as a flexible printed circuit board, and may be incorporated on or within a sleeve 9107 (e.g., a silicone rubber sleeve), demonstrated by the stippling portion in Fig. 18. The sleeve 9107 may overlay the conduit headgear 4180 and may be removable relative to the conduit headgear 4180, or the sleeve 9107 may be fixedly coupled to an outer surface of the conduit headgear 4180 (e.g., to the first portion 4180A of the conduit headgear 4180 or to both the first portion 4180A and the second portion 4180B). The sleeve 9107 may surround (e.g., wrap around) a portion of the conduit headgear 4180 or surround an entire circumference of the conduit headgear 4180. Additionally or alternatively, the sleeve 9107 may extend along an entire length or less than an entire length of the first portion 4180A and the second portion 4180B of conduit headgear 4180. In some aspects, the sleeve 9107 may cover a majority of or substantially all of an outer surface of the conduit headgear 4180 including, e.g., around an opening in the conduit headgear 4180 configured to couple to air circuit 4170.

[0513] The sleeve 9107 may be comprised of one or more materials. For example, the sleeve 9107 may be comprised of one or more of a flexible conductive silicone, conductive fibers or threads, a stretchable conductive textile or other suitable materials or combinations of materials. The material may include conductive traces, e.g., copper traces, or conductive fibers or threads that may be printed, thermally bonded, sewn, or otherwise incorporated onto or into the material. In some aspects, a metal gel soft circuit may be used to form the electrical connection(s) 9105. The metal gel soft circuit may comprise a membrane that may be bonded to a textile version of the sleeve 9107. Additionally, the metal gel soft circuit may include one or more stabilizing additives to allow the material to withstand high-pressure lamination and thermo-welding processes without displacement. The metal gel soft circuit may be configured to withstand bending, stretching, or torsion.

[0514] The sleeve 9107 may be comprised of flexible materials and / or stretchable materials and may include a corrugated portion or be configured to stretch or otherwise accommodate a corrugated portion, such as the first concertina portion 4200 A and / or the second concertina portion 4200B of the conduit headgear 4180. For example, the sleeve 9107 may be configured to be extended or stretched and compressed to accommodate thelength of the first portion 4180 A or the second portion 4180B of conduit headgear 4180 as it changes.

[0515] Additionally or alternatively, the sleeve 9107 may also include the second antenna 9100B and the third antenna 9100C. For example, the second antenna 9100B may be disposed on or within a first end of the sleeve 9107 (e.g., near or adjacent to the attachment location of the air circuit 4170), and / or third antenna 9100C may be disposed on or within a second end of the sleeve 9107 (e.g., near or adjacent to patient interface 3000’)- If the sleeve 9107 is configured to cover both the first portion 4180A and the second portion 4180B of the conduit headgear 4180, then one or more additional antennas may be disposed on or within the sleeve 9107, e.g., if approximately symmetrical antenna extensions are provided along both the first portion 4180A and the second portion 4180B of the conduit headgear 4180.

[0516] Fig. 19 illustrates a top perspective view of an exemplary portion of the conduit headgear 4180. In this configuration, the second antenna 9100B encircles or surrounds an opening 4182 where the air circuit 4170 is configured to couple to the conduit headgear 4180. The second antenna 9100B may be, for example, incorporated into a material from which the conduit headgear 4180 is made surrounding the opening 4182, may be printed, thermally bonded, adhered, or coated around the opening 4182, or may be incorporated into a sleeve, e.g., a textile sleeve, that fits over the conduit headgear 4182 and surrounds the opening 4182. The opening 4182 is configured to be coupled (e.g., directly or indirectly) to the air circuit 4170. Although not shown, in some configurations, the first antenna 9100A encircles or surrounds a corresponding opening on the air circuit 4170.

[0517] To accommodate the corrugations of the first concertina portion 4200A, the electrical connection(s) 9105 may include a distal portion 9105 A having a plurality of curves 9106. The plurality of curves 9106 may extend along an entire length of the first concertina portion 4200A or along a portion of the first concertina portion 4200A. Accordingly, the plurality of curves 9106 may include one curve, two curves, three curves, etc. The plurality of curves 9106 may enable the electrical connection(s) 9105 to extend and / or contract, for example, as the first concertina portion 4200A is expanded and / or contracted. The electrical connection(s) 9105, including the plurality of curves9106, may be formed from a stretchable conductive silicone. In some embodiments, the stretchable conductive silicone may be threads or fibers printed, thermally bonded, adhered, overmolded, or coated to the material from which the conduit headgear 4180 is formed.

[0518] Additionally or alternatively, the electrical connection(s) 9105 may be formed from a stretchable conductive textile with printed conductive, e.g., copper traces. The stretchable conductive textile with printed conductive, e.g., copper, traces may be thermally bonded to the conduit headgear 4180, which may be formed, e.g., of silicone. Additionally or alternatively, a metal gel soft circuit may be used to form the electrical connection(s) 9105. The metal gel soft circuit may comprise a membrane that may be bonded to the conduit headgear 4180, which may be formed of a silicone part. A metal gel soft circuit may alternatively comprise a membrane that may be bonded onto a textile. Additionally, the metal gel soft circuit may include one or more stabilizing additives to allow the material to withstand high-pressure lamination and thermo-welding processes without displacement. The metal gel soft circuit may be configured to withstand bending, stretching, or torsion. Any one or combination of these materials may be utilized to form and incorporate the electrical connection(s) 9105 and / or one or more antennas to the conduit headgear 4180.

[0519] In some examples, electrical connection 9105 may be integrated within the material comprising the conduit headgear 4180, as discussed above. For example, electrical connection 9105 may be overmolded or otherwise formed with conduit headgear 4180, which may be a silicone rubber. In such a way, electrical connection 9105 may be comprised of one or more flexible materials (e.g., polyimide or another amorphous plastic, TPU, PET, and / or a silicone film). For example, electrical connection 9105 may be formed as an extended flexible printed circuit board comprising at least three layers. For example, electrical connection 9105, and each layer thereof, may have any or all of the characteristics discussed above with respect to Figs. 7A, 7B, 8A-8C, 9A- 9C, 10A-10E, and / or 11. Electrical connection 9105 may include any or all of the characteristics discussed above so as to improve adhesion of electrical connection 9105 on or within conduit headgear. Incorporating any or all of the characteristics discussed above with respect to Figs. 7A, 7B, 8A-8C, 9A-9C, 10A-10E, and / or 11 with electricalconnection 9105 may, for example, improve adhesion of electrical connection 9105 on or within conduit headgear 4180.

[0520] Fig. 20 illustrates the patient interface 3000', the conduit headgear 4180, and the air circuit 4170 in fluid communication with one another while being worn by a patient. For example, the conduit headgear 4180 is configured such that the air circuit 4170 is coupled to the conduit headgear 4180 at or near the top of the patient’s head, for example, via the joint 4190. The air circuit 4170 may be rotatable relative to conduit the headgear 4180 via the joint 4190. For example, the joint 4190 may be a swivel joint, thus permitting the air circuit 4170 to rotate relative the conduit headgear 4180. Additionally, the conduit headgear 4180 and the air circuit 4170 may be angled relative to one another. For example, via the joint 4190, the air circuit 4170 may be approximately 90 degrees relative to the conduit headgear 4180. Accordingly, in some aspects, the first antenna 9100A, which may be fixed in or on proximal portion of the air circuit 4170, may be angled relative to the second antenna 9100B fixed in or on the conduit headgear 4180.

[0521] As previously discussed, the electrical connection(s) 9105 physically and electrically couple second the antenna 9100B to the third antenna 9100C. The electrical connection(s) 9105 may include a plurality of curves 9106 along the first concertina portion 4200A or the second concertina portion 4200B (FIGs. 18 and 19), thus permitting the electrical connection(s) 9105 to extend and / or contract, for example, as the first concertina portion 4200A is extended and / or contracted. In such a way, signals from the third antenna 9100C may be transmitted to second antenna 9100B via the electrical connection(s) 9105.

[0522] As discussed above, the electrical connection(s) 9105 may include a plurality of curves 9106. The plurality of curves 9106 may extend along a portion of the electrical connection 9105, as shown. By arranging the electrical connection 9105 with the plurality of curves 9106 or, for example, in such a zig-zag / serpentine path, stretching or bending of the conduit headgear 4180 may result in relatively little increase in tensile forces on the electrical connection 9105. This may allow use of an electrical connection 9105 that has relatively little stretch or an electrical connection 9105 that is stretchable. This configuration may also reduce the chances of the electrical connection 9105 failing due to repeated stretching and / or bending cycles.

[0523] As discussed above, the electrical connection 9105 may be integrated within the material comprising the conduit headgear 4180, which may be a silicone rubber. For example, electrical connection 9105 may be overmolded or otherwise formed with conduit headgear 4180. In such a way, electrical connection 9105 may be comprised of one or more flexible materials (e.g., polyimide or another amorphous plastic, TPU, PET, and / or a silicone film). For example, electrical connection 9105 may be formed as an extended flexible printed circuit board comprising at least three layers. For example, electrical connection 9105, and each layer thereof, may have any or all of the characteristics discussed above with respect to Figs. 7A, 7B, 8A-8C, 9A-9C, 10A-10E, and / or 11. Electrical connection 9105 may include any or all of the characteristics discussed above so as to improve adhesion of electrical connection 9105 on or within conduit headgear 4180 and / or sleeve 9107. Incorporating any or all of the characteristics discussed above with respect to Figs. 7A, 7B, 8A-8C, 9A-9C, 10A-10E, and / or 11 with electrical connection 9105 may, for example, improve adhesion of electrical connection 9105 on or within conduit headgear 4180.

[0524] The embodiments discussed herein may enable the user to detect identification of the patient interface or accessory being used, among other things. The embodiments discussed herein may include RFID devices, such as, for example an RFID tag. Additionally or alternatively, the embodiments discussed herein may include one or more electrical wires, cables, or other conductive elements configured to transmit electrical signals. The embodiments discussed herein may enable the RFID tag and / or the wire(s) / cable(s) / conductive element(s) to be coupled to one or more components of the respiratory therapy system.

[0525] It will be apparent to those skilled in the art that various modifications and variations can be made to the disclosed device without departing from the scope of the disclosure. Other embodiments of the disclosure will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims

6 CLAIMSWe claim:

1. A respiratory therapy system, comprising: a patient interface; and a radio frequency identification (RFID) tag fixed to the patient interface, the RFID tag comprisinga flexible circuit board, wherein the flexible circuit board includes a first layer, a second layer, and a third layer, wherein the second layer is disposed between the first layer and the third layer, where the second layer includes a first surface and a second surface opposite the first surface, wherein the first layer comprises an overlay affixed to the first surface of the second layer, wherein the third layer comprises an overlay affixed to the second surface of the second layer, and wherein the second layer comprises a conductive material.

2. The respiratory therapy system according to claim 1 , wherein the first layer and / or the third layer comprises a polyimide or another amorphous plastic, thermoplastic polyurethanes, polyethylene terephthalate, and / or a silicone film.

3. The respiratory therapy system according to any one of claims 1 to 2, wherein the first layer and / or the third layer includes an outer surface having an improved bonding strength, improved adhesion capabilities, a higher surface roughness and / or improved coupling capabilities relative to an inner surface thereof, wherein the inner surface thereof is affixed to the second layer.

4. The respiratory therapy system according to any one of claims 1 to 3, wherein the first layer and / or the third layer includes an etching configured to roughen an outer surface thereof.

5. The respiratory therapy system according to any one of claims 1 to 4, wherein the first layer and / or the third layer comprises one or more features on an outer surface thereof.

6. The respiratory therapy system according to claim 5, wherein the one or more features include an indentation or projection.

7. The respiratory therapy system according to claim 6, wherein the one or more features includes the projection, and wherein the projection has a frustoconical shape, an L shape, and / or a mushroom shape.

8. The respiratory therapy system according to any one of claims 1 to 7, wherein the first layer and / or the third layer has at least one through hole extending therethrough.

9. The respiratory therapy system according to any one of claims 1 to 8, further comprising at least one through hole extending through the first layer, the second layer, and the third layer.

10. The respiratory therapy system according to any one of claims 1 to 9, further comprising a silicone material at least partially surrounding the flexible circuit board.

11. The respiratory therapy system according to any one of claims 1 to 10, wherein the flexible circuit board is encapsulated.

12. A respiratory therapy system, comprising: an air circuit; and a radio frequency identification (RFID) tag fixed to the air circuit, the RFID tag comprising a flexible circuit board, wherein the flexible circuit board includes a first layer, a second layer, and a third layer,wherein the second layer is disposed between the first layer and the third layer, where the second layer includes a first surface and a second surface opposite the first surface, wherein the first layer comprises an overlay affixed to the first surface of the second layer, wherein the third layer comprises an overlay affixed to the second surface of the second layer, and wherein the second layer comprises a conductive material.

13. The respiratory therapy system according to claim 12, wherein the first layer and / or the third layer comprises a polyimide or another amorphous plastic, thermoplastic polyurethanes, polyethylene terephthalate, and / or a silicone film.

14. The respiratory therapy system according to any one of claims 12 to 13, wherein the first layer and / or the third layer includes an outer surface having an improved bonding strength, improved adhesion capabilities, a higher surface roughness and / or improved coupling capabilities relative to an inner surface thereof, wherein the inner surface thereof is affixed to the second layer.

15. The respiratory therapy system according to any one of claims 12 to 14, wherein the first layer and / or the third layer includes etching configured to roughen an outer surface thereof.

16. The respiratory therapy system according to any one of claims 12 to 15, wherein the first layer and / or the third layer comprises one or more features on an outer surface thereof.

17. The respiratory therapy system according to claim 16, wherein the one or more features include an indentation or projection.

18. The respiratory therapy system according to claim 17, wherein the one or more features includes the projection, and wherein the projection has a frustoconical shape, an L shape, and / or a mushroom shape.

19. The respiratory therapy system according to any one of claims 12 to 18, wherein the first layer and / or the third layer has at least one through hole extending therethrough.

20. The respiratory therapy system according to any one of claims 12 to 19, further comprising at least one through hole extending through the first layer, the second layer, and the third layer.

21. The respiratory therapy system according to any one of claims 12 to 20, further comprising a silicone material at least partially surrounding the flexible circuit board.

22. The respiratory therapy system according to any one of claims 12 to 21, wherein the flexible circuit board is encapsulated.I ll

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