Respiratory treatment system

Abstract

The utility model relates to a respiratory therapy system. A respiratory therapy system may include a patient interface and a radio frequency identification (RFID) tag secured to the 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 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 includes a cover layer attached to a first surface of the second layer. The third layer includes a cover layer attached to a second surface of the second layer. The second layer may include a conductive material.

Description

[0001] Cross Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 515,681, filed July 26, 2023, which is incorporated herein in its entirety by reference. 1TECHNICAL FIELD

[0004] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of a respiratory-related disorder. The present technology also relates to medical devices or apparatus, systems, and the use thereof. 2BACKGROUND

[0006] 2.2Description of Related Art

[0007] 2.2.1 The Human Respiratory System and Its Disorders

[0008] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of the patient.

[0009] The airways include a sequence of branching tubes when the branching airways penetrate deeper into the lung they become narrower, shorter, and more numerous. The main function of the lung is gas exchange, allowing oxygen to move from inhaled air to venous blood and carbon dioxide in the opposite direction. The trachea divides into the left and right main bronchus, which eventually subdivide into terminal bronchioles. The bronchi constitute the conducting airways but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles, and eventually to the alveoli. The alveolar region of the lung is where gas exchange occurs, and is called the respiratory zone. See West, John B. Respiratory Physiology, 9thedition, Lippincott Williams & Wilkins, 2012.

[0010] There is a range of respiratory disorders. Certain disorders can be characterised by particular events, such as apneas, hypopneas, and hyperpneas.

[0011] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and Chest Wall Disorders.

[0012] Obstructive Sleep Apnea (OSA) is a form of Sleep Disordered Breathing (SDB) which involves partial or complete obstruction of the upper airway during sleep. It is caused by the combination of an abnormally small upper airway and muscle tone loss 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 of time, typically between 30 seconds and 120 seconds, sometimes 200 to 300 times per night. This frequently results in excessive daytime sleepiness, and can cause cardiovascular disease and brain damage. The syndrome is common, particularly in middle aged overweight males, but the people affected can be unaware of the problem. See US Patent No. 4,944,310 (Sullivan).

[0013] Cheyne-Stokes Respiratory (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, rhythmic de-oxygenation and re-oxygenation of the arterial blood. CSR can be harmful due to the repeated hypoxia. In some patients CSR is associated with repetitive arousal from sleep, which results in severe sleep disruption, increased sympathetic activity, and increased afterload. See US Patent No. 6,532,959 (Berthon-Jones).

[0014] Respiratory failure is an encompassing term for respiratory diseases in which the lungs can't draw enough oxygen or expel enough carbon dioxide from the patient's body. Respiratory failure can encompass some or all of the following diseases.

[0015] A patient with respiratory insufficiency, a form of respiratory failure, can experience abnormally short breaths when exercising.

[0016] Obesity hypoventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia in the presence of a normal awake PaC02, in the absence of any other known cause of hypoventilation. Symptoms include breathlessness, morning headaches, and excessive daytime sleepiness.

[0017] 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, an extended expiratory phase of respiration, and loss of the normal elasticity of the lung. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (the primary risk factor), occupational exposures, air pollution, and genetic factors. Symptoms include labored breathing, chronic cough, and sputum production.

[0018] Neuromuscular Disease (NMD) is a broad term that encompasses many diseases and ailments that impair the functioning of the muscles either directly by intrinsic muscle pathology, or indirectly by nerve pathology. Some NMD patients are characterised by progressive muscular impairment leading to loss of ambulation, being wheelchair-bound, dysphagia, 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 leads to death within a few years (e.g. Amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: Characterised by muscle impairment that worsens over years, and only shortens life by a few years (e.g. Limb girdle, Facioscapulohumeral, and Myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing generalised weakness, dysphagia, breathlessness during exercise and at rest, fatigue, sleepiness, morning headache, and difficulty concentrating and mood changes.

[0019] Chest wall disorders are a group of thoracic deformities that result in inefficient coupling of the respiratory muscles to the thoracic cage. These disorders are often characterised by a restrictive defect and share the potential for long term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: breathlessness, peripheral oedema, orthopnea, repeated chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0020] A range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals can take advantage of such therapies to prevent respiratory disorders from arising. However, these have a number of shortcomings.

[0021] 2.2.2 Treatment

[0022] A variety of respiratory therapies have been used to treat one or more of the above respiratory disorders, for example Continuous Positive Airway Pressure (CPAP) therapy, Non-invasive ventilation (NIV), Invasive ventilation (IV) and High Flow Therapy (HFT).

[0023] 2.2.2.1 Respiratory pressure therapy

[0024] Respiratory pressure therapy is the application of air supply to the airway entrance at a controlled target pressure that is nominally positive with respect to atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapies such as the tank respirator or cuirass).

[0025] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy can be voluntary, and thus patients can elect not to comply with treatment if they find the device used to provide such therapy to be any one or more of: uncomfortable, difficult to use, expensive, and aesthetically unappealing.

[0026] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airways, to assist the patient to breathe 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 the form of OHS, COPD, NMD, and Chest Wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0027] Invasive ventilation (IV) provides ventilatory support to a patient who is not able to breathe effectively on their own, and can be provided using an tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0028] 2.2.2.2 Flow therapy

[0029] Not all respiratory therapies aim to deliver a prescribed therapy pressure. Some respiratory therapies aim to deliver a prescribed respiratory volume by delivering an inspiratory flow profile over a target duration of time (possibly superimposed on a positive baseline pressure). In other cases, the interface to the patient's airways is "open" (unsealed) and the respiratory therapy can supplement the patient's own spontaneous breathing with a flow of conditioned or enriched gas. In one example, high flow therapy (HFT) is the delivery of a continuous, heated, humidified flow of air at an "treatment flow rate" that can remain approximately constant throughout the respiratory cycle, to the entrance of the airways via an unsealed or "open" patient interface. The treatment flow rate is nominally set to exceed the peak inspiratory flow rate of the patient. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high flow of air at the entrance to the airways improves ventilation efficiency by flushing or washing out exhaled CO2 from the patient's anatomic dead space. HFT is therefore sometimes referred to as deadspace therapy (DST). Other benefits can include elevated warmth and humidification (possibly beneficial to secretion management), and the potential for modest elevations in pressure at the airways. As an alternative to a constant flow, the treatment flow rate can follow a profile that varies with the respiratory cycle.

[0030] Another form of flow therapy is long-term oxygen therapy (LTOT) or supplemental oxygen therapy. A physician can prescribe a continuous flow of oxygen enriched air to be delivered to the patient's airways at a specified oxygen concentration (from 21% of the fraction of oxygen in ambient air up to 100%) at a specified flow rate (e.g. 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.). The flow rate is typically delivered via nasal or facial

[0031] 2.2.2.3 Supplemental oxygen

[0032] For some patients, oxygen therapy can be combined with respiratory pressure therapy or HFT by adding supplemental oxygen to the pressurised flow. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is referred to as HFT with supplemental oxygen.

[0033] 2.2.3 Respiratory therapy systems

[0034] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen for, diagnose, or monitor a condition without treating it.

[0035] A respiratory therapy system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0036] Another form of therapy system is a mandibular repositioning device.

[0037] 2.2.3.1 Patient interface

[0038] A patient interface can be used to interface a respiratory apparatus to its wearer, for example by providing a flow of air to an entrance to the airways. The flow of air can be provided via a mask to the nose and / or mouth, via a tube to the mouth, or via a tracheal tube to the trachea of a patient. Depending on the therapy to be applied, the patient interface can form a seal, for example with areas of the patient's face, to facilitate the delivery of gas at a pressure sufficiently different from ambient pressure (e.g. positive pressure of around 10 cmH20 relative to ambient pressure) to effect therapy. For other forms of therapy, such as oxygen delivery, the patient interface can not include a seal sufficient to facilitate delivery to the airways of a supply of gas at around 10 cmH20 of positive pressure. For flow therapies such as nasal HFT, the patient interface is configured to blow gas into the nares, but specifically to avoid a full seal. One example of such a patient interface is a nasal cannula.

[0039] Certain other mask systems can not be functionally suitable for use in the art. For example, purely decorative masks can not maintain an appropriate pressure. Mask systems used for underwater swimming or diving can be configured to prevent water from the higher pressure outside from entering, but will not maintain the internal air at a pressure higher than ambient pressure.

[0040] Certain masks can be clinically disadvantageous for the present technology, for example if they obstruct airflow through the nose and only allow it through the mouth.

[0041] Certain masks can be uncomfortable or impractical for the present technology if the patient is required to insert a portion of the mask structure in their mouth to create and maintain a seal through their lips.

[0042] Certain masks can be impractical for use while sleeping, for example when lying on one's side in bed with the head on a pillow.

[0043] The design of patient interfaces presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head varies greatly between different individuals. As the head includes bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The entire head can move during respiratory therapy.

[0044] As a result of these challenges, some masks suffer from one or more of the problems of being protruding, aesthetically undesirable, expensive, ill-fitting, difficult to use, and uncomfortable, particularly when worn for long periods or when the patient is not familiar with the system. Masks that are incorrectly sized can result in reduced compliance, reduced comfort, and poorer patient outcomes. Masks designed only for pilots, masks designed as part of personal protection equipment (such as filtering masks), SCUBA masks, or masks for the administration of anaesthetics can be tolerable for their original application, but nonetheless such masks can be undesirably uncomfortable when worn for long periods of time (e.g. several hours). This discomfort can result in reduced patient compliance with therapy. This is even more so if the mask is worn during sleep.

[0045] CPAP therapy is highly effective for treating certain respiratory disorders, provided that the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient can not comply with the therapy. Because it is generally recommended that patients clean their masks on a regular basis, if the mask is difficult to clean (e.g. difficult to assemble or disassemble), the patient can not clean their mask, and this can impact the patient's compliance.

[0046] While masks for other applications (e.g. navigators) can not be suitable for treating sleep disordered breathing, masks designed for treating sleep disordered breathing can be suitable for other applications.

[0047] For these reasons, patient interfaces for the delivery of CPAP during sleep form a distinct field.

[0048] 2.2.3.1.1 Seal-forming structure

[0049] The patient interface can include a seal-forming structure. The shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface, as the seal-forming structure is in direct contact with the patient's face.

[0050] The patient interface can be characterized in part by the intended design of the seal-forming structure to interface with the face in use. In one form of patient interface, the seal-forming structure can include a first sub-portion to form a seal around the left nare and a second sub-portion to form a seal around the right nare. In one form of patient interface, the seal-forming structure can include a single element to enclose both nare in use. Such a single element can be designed to cover, for example, the lip superior region and the bridge of the nose region of the face. In one form of patient interface, the seal-forming structure can include an element to enclose the mouth region in use, for example by forming a seal over the lower lip region of the face. In one form of patient interface, the seal-forming structure can include a single element to enclose the nare and the mouth region in use. These different types of patient interfaces can be known by various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal cradle, and mouth-nose masks.

[0051] A seal-forming structure that is effective in one region of a patient's face can be inappropriate in another region, for example due to different shape, structure, variability, and sensitive regions of a patient's face. For example, a seal on a swimming goggle that covers a patient's forehead can be inappropriate for use on a patient's nose.

[0052] Certain seal-forming structures can be designed for mass production, such that one design fits and is comfortable and effective for a wide range of different face shapes and sizes. To the extent that there is a mismatch between the shape of a patient's face and the seal-forming structure of a mass-produced patient interface, one or the other must be modified to form a seal.

[0053] 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 face-to-face engagement with the patient's face. This seal-forming structure can include an air or fluid-filled cushion, or a molded or formed surface of an elastomeric (e.g., rubber) resilient sealing element. With this type of seal-forming structure, if the fit is not adequate, there will be a gap between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0054] Another type of seal-forming structure incorporates a flap seal of thin material around the periphery of the mask to provide a self-seal against the patient's face when positive pressure is applied within the mask. Like the previous types of seal-forming portions, additional force can be required to achieve a seal if the face-to-mask fit is not good, or the mask can leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it can crease or buckle in use, causing a leak.

[0055] Another type of seal-forming structure can include a friction fit element, for example for insertion into the nares, however some patients find these uncomfortable.

[0056] Another form of seal-forming structure can use an adhesive to achieve a seal. Some patients can find it inconvenient to apply and remove the adhesive from their face on a regular basis.

[0057] 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.

[0058] 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 U.S. Patent 4,782,832 (Trimble et al.) assigned to Puritan-Bennett Corporation.

[0059] ResMed Limited manufactures the following products incorporating nasal pillows: the SWIFT™ nasal pillows mask, the SWIFT™ II nasal pillows mask, the SWIFT™ LT nasal pillows mask, the SWIFT™ FX nasal pillows mask, and the MIRAGE LIBERTY™ full-face mask. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: International Patent Application WO 2004 / 073,778 (describing further aspects of the ResMed Limited SWIFT™ nasal pillows); U.S. Patent Application 2009 / 0044808 (describing further aspects of the ResMed Limited SWIFT™ LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (describing further aspects of the ResMed Limited MIRAGE LIBERTY™ full-face mask); International Patent Application WO 2009 / 052,560 (describing further aspects of the ResMed Limited SWIFT™ FX nasal pillows).

[0060] 2.2.3.1.2 Positioning and stabilisation

[0061] Seal-forming structures of patient interfaces for positive air pressure therapy are subject to corresponding forces of air pressure to disrupt the seal. Accordingly, various techniques have been used to position the seal-forming structure and to maintain it in sealing relationship with the appropriate portion of the face.

[0062] One technique is the use of adhesive. See, for example, US Patent Application Publication No. US 2010 / 0000534. However, the use of adhesive can be uncomfortable for some people.

[0063] Another technique is the use of one or more straps and / or stabilising straps. Many such straps suffer from one or more of the problems of being ill-fitting, cumbersome, uncomfortable and inconvenient to use.

[0064] 2.2.3.2 Respiratory pressure therapy (RPT) devices

[0065] Respiratory pressure therapy (RPT) devices can be used either alone or as part of a system to deliver one or more of a number of therapies described above, for example by operating the device to generate a flow of air for delivery to an interface to the airways. The flow of air can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Thus, RPT devices can also be used as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0066] Air pressure generators are known in a variety of applications, for example industrial scale ventilation systems. However, air pressure generators for medical applications have particular requirements that are not met by more general air pressure generators, for example reliability, size and weight requirements of medical devices. Furthermore, even devices designed for medical therapy can have drawbacks relating to one or more of: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost and reliability.

[0067] One example of a particular requirement of certain RPT devices is noise.

[0068] Table of noise output levels of existing RPT devices (only one sample, measured in CPAP mode at 10 cmH20 using the test method specified in ISO 3744).

[0069]

[0070] One known RPT device for treating sleep disordered breathing is the S9 Sleep Therapy System, manufactured by ResMed Limited. Another example of an RPT device is a ventilator. Ventilators, such as the ResMed Stellar™ Series Adult and Paediatric Ventilators TMThe Series can provide both invasive and non-invasive non- dependent ventilation support for a range of patients for the treatment of a number of conditions such as, but not limited to, NMD, OHS and COPD.

[0071] ResMed Elisee TM 150 Ventilator and treated ResMed VS III TM Ventilators can provide invasive and non-invasive dependent ventilation support suitable for adult or paediatric patients for the treatment of a number of conditions. These ventilators provide volume and pressure ventilation modes with either a single-limb circuit or a double-limb circuit. RPT devices typically include a pressure generator, such as a motor-driven blower or a compressed gas storage tank, and are configured to supply a flow of air to the airway of a patient. In some cases, the flow of air can be supplied at a positive pressure to the airway of a patient. The outlet of the RPT device is connected via an air circuit to a patient interface, such as those described above.

[0072] The designer of a device can be presented with an infinite number of choices to make. Design criteria often conflict, meaning that some design choices are far from conventional or inevitable. Furthermore, comfort and efficacy in some areas can be highly sensitive to small subtle changes in one or more parameters.

[0073] 2.2.3.3 Air circuit

[0074] An air circuit is a conduit or tube constructed and arranged to, in use, allow a flow of air to travel between two components of a respiratory therapy system, such as an RPT device and a patient interface. In some cases, there can be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for inhalation and exhalation.

[0075] 2.2.3.4 Humidifier

[0076] Delivery of a flow of air without humidification can cause drying of the airways. The use of a humidifier with an RPT device and a patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. Furthermore, in cooler climates, warm air is generally more comfortable to apply into and around the facial area of the patient interface than cold air.

[0077] Many artificial humidification devices and systems are known, however, they do not meet the special requirements of a medical humidifier.

[0078] Medical humidifiers are used when needed to increase the humidity and / or temperature of an air flow relative to ambient air, typically where a patient is sleeping or resting, such as in a hospital. Medical humidifiers for bedside placement can be small. Medical humidifiers can be configured to humidify and / or heat only the air flow delivered to the patient, without humidifying and / or heating the patient's surroundings. For example, room-based systems, such as a sauna, air conditioner, or evaporative cooler, can also humidify the air inhaled by a patient, however these systems also humidify and / or heat the entire room, which can cause discomfort to the occupants. In addition, medical humidifiers can have more stringent safety constraints than industrial humidifiers.

[0079] While many medical humidifiers are known, they can have one or more shortcomings. Some medical humidifiers can provide inadequate humidification, some are difficult or inconvenient for patients to use.

[0080] 2.2.3.5 Oxygen source

[0081] Experts in the field have recognized that exercise for patients with respiratory failure provides long-term benefits that slow the progression of the disease, improve quality of life, and extend the patient's life. However, most stationary forms of exercise such as treadmills and stationary bicycles are too strenuous for these patients. As a result, the need for mobility has long been recognized. Until recently, mobility has been facilitated by the use of small compressed oxygen tanks or cylinders mounted on carts with wheels. The disadvantage of these tanks is that they contain a finite amount of oxygen and are heavy, weighing about 50 pounds when mounted.

[0082] Oxygen concentrators have been used for about 50 years to provide oxygen for respiratory therapy. Conventional oxygen concentrators are large and bulky, making ordinary ambulatory activities difficult and impractical. Recently, companies that manufacture large stationary oxygen concentrators have begun to develop portable oxygen concentrators (POCs). The advantage of POCs is that they can produce theoretically unlimited supplies of oxygen. To make the mobility of these devices small, the various systems used to produce oxygen-rich gas need to be condensed. POCs seek to utilize as efficiently as possible the oxygen they produce to minimize weight, size, and power consumption. This can be accomplished by delivering the oxygen in a series of pulses, each pulse or "bolus" timed to coincide with the start of inhalation. This mode of therapy is called pulsed oxygen delivery (POD) or demand mode, as opposed to the more conventional continuous flow delivery that is better suited for stationary oxygen concentrators.

[0083] 2.2.3.6 Data management

[0084] There can be clinical reasons to obtain data to determine whether a patient prescribed 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 is required to use the RPT device for at least 4 hours on a single night for at least 21 of 30 consecutive days in order to be considered compliant. In order to determine a patient's compliance, a provider of the RPT device (e.g. a healthcare provider) can manually obtain data describing the patient's therapy using the RPT device, calculate the usage over a predetermined period of time, and compare to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device according to the compliance rules, the healthcare provider can notify a third party that the patient is compliant.

[0085] There can be other aspects of patient therapy that would benefit from communication of therapy data to third parties or external systems.

[0086] Existing processes of communicating and managing such data can be one or more of expensive, time consuming and error prone.

[0087] 2.2.3.7 Ventilation techniques

[0088] Some forms of therapy system can include a vent to allow flushing of exhaled carbon dioxide. The vent can allow gas to flow from an interior space of the patient interface, e.g. a plenum chamber, to an exterior of the patient interface, e.g. the ambient environment.

[0089] The vent can include an orifice and in use of the mask the gas can flow through the orifice. Many such vents are noisy. Others can become blocked in use and thus provide inadequate flushing. Some vents can disrupt the sleep of a bed partner 1100 of the patient 1000, e.g. by noise or focussed gas flow.

[0090] ResMed Limited has developed a number of improved mask venting techniques. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381 ; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0091] Noise table for existing masks (ISO 17510-2:2007, 10 cmH20 pressure 1 m)

[0092]

[0093] (* only one sample, measured at 10 cmH20 in CPAP mode using the test method specified in ISO 3744)

[0094] The sound pressure values for various objects are listed below

[0095]

[0096] 2.2.4 Screening, diagnosis and monitoring systems

[0097] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiorespiratory disorders, and typically involves a clinical specialist to apply the system. PSG typically involves placing 15 to 20 contact sensors on a patient to record various body signals such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep disordered breathing involves observing a patient for two nights in a clinic, one night purely for diagnosis and a second night for the clinician to titrate treatment parameters. PSG is therefore expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep disordered breathing.

[0098] Screening and diagnosis generally describe identifying a condition from signs and symptoms of the condition. Screening typically gives a true / false result indicating whether the patient's SDB is severe enough to warrant further investigation, whereas diagnosis can produce clinically actionable information. Screening and diagnosis tend to be one-off processes, whereas monitoring the progress of the condition can continue indefinitely. Some screening / diagnosis systems are suitable only for screening / diagnosis, whereas some can also be used for monitoring.

[0099] A clinical specialist can be able to adequately screen, diagnose or monitor a patient from visual observation of PSG signals. However, there are situations where a clinical specialist can not be available or can not be affordable. Different clinical specialists can disagree on a patient's condition. Furthermore, a given clinical specialist can apply different criteria at different times. 3. Utility Content

[0101] The technology is directed towards providing a medical device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder, with one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0102] A first aspect of the technology relates to an apparatus for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0103] An aspect of certain forms of the technology is to provide an apparatus for improving patient compliance with respiratory therapy.

[0104] One form of the technology includes a positioning and stabilising structure configured to provide a force that holds a seal-forming structure in a therapeutically effective position on the patient’s head. The positioning and stabilising structure includes at least one strap.

[0105] One form of the technology includes a patient interface that includes a plenum chamber, a seal-forming structure, and a positioning and stabilising structure.

[0106] One form of the technology includes a patient interface that includes 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 said therapeutic pressure for breathing by a patient. The patient interface also includes a seal-forming structure constructed and arranged to form a seal with a region of the patient’s face surrounding the entrance of the patient’s nares. The seal-forming structure has a hole therein such that the flow of air at said therapeutic pressure is delivered to at least the entrance of the patient’s nares. The seal-forming structure is constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout a patient’s respiratory cycle in use. The patient interface also includes a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head.

[0107] Another aspect of one form of the technology is a series of modular elements that can be interconnected so as to form different types of patient interfaces.

[0108] In one form, each modular element has at least two versions or types. The versions or types can be used interchangeably with one another so as to form different modular assemblies.

[0109] One form of the technology includes a respiratory therapy system comprising: a patient interface; an air circuit configured to be removably coupled to the patient interface; a radio frequency identification (RFID) tag associated with the patient interface, the RFID tag configured to store information about the patient interface; an antenna; and a transceiver, wherein the transceiver can be configured to wirelessly receive the information stored on the RFID tag and transmit the information to a controller when the air circuit can be coupled to the patient interface.

[0110] In one aspect of the present technology, a radio frequency identification (RFID) tag and / or antenna can be secured to a patient interface and / or an air circuit. One or both of the RFID tag and / or antenna can include a flexible circuit board. The flexible circuit board can include a first layer, a second layer, and a third layer. The second layer can be disposed between the first layer and the third layer. The second layer can include a first surface and a second surface opposite the first surface. The first layer can include a cover layer attached to the first surface of the second layer. The third layer can include a cover layer attached to the second surface of the second layer. The second layer can include a conductive material. In some aspects, the flexible circuit board of the RFID tag and / or the antenna can each include additional layers (e.g., four layers, five layers, six layers, etc.). For example, the flexible circuit board can include additional cover layers and / or additional layers of conductive material. In some aspects, the RFID tag and / or the antenna can each include additional flexible circuit boards (e.g., two circuit boards, three circuit boards, etc.).

[0111] In some aspects, the first layer and / or the third layer can include a polyimide or another amorphous plastic, a thermoplastic polyurethane, a polyethylene terephthalate, and / or a silicone membrane.

[0112] In some aspects, the first layer and / or the third layer can include an outer surface having improved bond strength, improved adhesion capability, higher surface roughness, and / or improved coupling capability relative to an inner surface of the first layer and / or the third layer, wherein the inner surface of the first layer and / or the third layer is secured to the second layer.

[0113] In some aspects, the first layer and / or the third layer include a plasma treatment or a corona treatment on an outer surface thereof. The first layer and / or the third layer can include an etch configured to roughen the outer surface thereof.

[0114] In some aspects, the first layer and / or the third layer can include one or more features on an outer surface thereof. The one or more features can include a recess and / or a protrusion. In some aspects, the one or more features can include the protrusion, and the protrusion can have a frustoconical shape, an L shape, and / or a mushroom shape.

[0115] In some aspects, the first layer and / or the third layer can have at least one through hole extending therethrough. The at least one through hole can extend through the first layer, the second layer, and the third layer.

[0116] In some aspects, a silicone material can at least partially surround the flexible circuit board. In certain aspects, the flexible circuit board is encapsulated.

[0117] In another aspect, a radio frequency identification (RFID) tag can be secured to a patient interface. The RFID tag can include a flexible circuit board. The flexible circuit board can include a first layer, a second layer, and a third layer. The second layer can be disposed between the first layer and the third layer. The second layer can include a first surface and a second surface opposite the first surface. The first layer can include a cover layer attached to the first surface of the second layer. The third layer can include a cover layer attached to the second surface of the second layer. The second layer can include a conductive material.

[0118] In another aspect, a radio frequency identification (RFID) tag can be secured to an air circuit. The RFID tag can include a flexible circuit board. The flexible circuit board can include a first layer, a second layer, and a third layer. The second layer can be disposed between the first layer and the third layer. The second layer can include a first surface and a second surface opposite the first surface. The first layer can include a cover layer attached to the first surface of the second layer. The third layer can include a cover layer attached to the second surface of the second layer. The second layer can include a conductive material.

[0119] In some aspects, the first layer and / or the third layer can include a polyimide or another amorphous plastic, a thermoplastic polyurethane, a polyethylene terephthalate, and / or a silicone membrane.

[0120] In some aspects, the first layer and / or the third layer can include an outer surface having improved bond strength, improved adhesion capability, higher surface roughness, and / or improved coupling capability relative to an inner surface of the first layer and / or the third layer, wherein the inner surface of the first layer and / or the third layer is secured to the second layer.

[0121] In one form, the first layer and / or the third layer can include a plasma treatment or a corona treatment on an outer surface thereof. The first layer and / or the third layer can include an etching configured to roughen the outer surface thereof.

[0122] In some aspects, the first layer and / or the third layer can include one or more features on an outer surface thereof. In some aspects, the one or more features can include a recess and / or a protrusion.

[0123] In some forms, the protrusion can have a frustoconical shape, an L-shape, and / or a mushroom shape.

[0124] In some aspects, the first layer and / or the third layer can have at least one through-hole extending therethrough. In some aspects, the at least one through-hole can extend through the first layer, the second layer, and the third layer.

[0125] In some aspects, a silicone material can at least partially surround the flexible circuit board. In some forms, the flexible circuit board can be encapsulated.

[0126] Of course, some of these aspects can form sub-aspects of the present technology. Furthermore, individual aspects from the aspects and / or sub-aspects can be combined in various ways, and also form further aspects or sub-aspects of the present technology.

[0127] Other features of the present technology will become apparent from consideration of the following detailed description, abstract, drawings and claims as well as the information included in the application as filed. 4BRIEF DESCRIPTION OF DRAWINGS

[0129] The present technology is illustrated by way of example, and not limitation, in the figures of the accompanying drawings in which like references indicate similar elements and in which:

[0130] FIGS. 1A-1C Each illustrates various configurations of a respiratory therapy system in use.

[0131] FIG. 2 A patient interface in the form of a nasal mask according to one form of the present technology is shown.

[0132] FIG. 3A A cushion for a mask including two pillows is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. The dome and saddle regions are indicated.

[0133] FIG. 3B A cushion for a mask is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. A path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle regions and a dome region are indicated.

[0134] FIG. 3C A surface of a structure having a one-dimensional hole in the surface is shown. The planar curve illustrated forms a boundary of the one-dimensional hole.

[0135] FIG. 3D A cross-section through a structure of FIG. 3C is shown. The surface illustrated bounds a two-dimensional hole in the structure of FIG. 3C .

[0136] FIG. 3E A perspective view of a structure of FIG. 3C is shown, including a two-dimensional hole and a one-dimensional hole. Also shown is the surface that bounds the two-dimensional hole in the structure of FIG. 3C .

[0137] FIG. 3F A mask having an inflatable bladder as a cushion is shown.

[0138] FIG. 3G A cross-section through a mask of FIG. 3G is shown, and the inner surface of the bladder is shown. The inner surface bounds a two-dimensional hole in the mask.

[0139] FIG. 3H Another cross-section through a mask is shown. FIG. 3F The inner surface is also indicated.

[0140] FIG. 4A is a schematic diagram of the pneumatic path of an RPT device according to one form of the present technology. The direction of upstream and downstream is indicated with reference to a blower and a patient interface. The blower is defined as being upstream of the patient interface and the patient interface is defined as being downstream of the blower, irrespective of the actual direction of flow at any particular instant. Items located within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0141] FIG. 4B is a schematic diagram of the electrical components of an RPT device according to one form of the present technology.

[0142] FIG. 4C is a schematic diagram of an algorithm implemented in an RPT device according to one form of the present technology.

[0143] FIG. 5A A perspective view of a cushion of a patient interface is shown, the patient interface being configured to be worn by a patient and to deliver pressurised air to the patient's nose and the patient's mouth.

[0144] FIG. 5B A perspective view of a cushion of a patient interface is shown, the patient interface being configured to be worn by a patient and to deliver pressurised air to the patient's nose.

[0145] FIG. 5C A perspective view of a tube is shown that can be used with the cushion of FIG. 5A or the cushion of FIG. 5B .

[0146] FIG. 5D A perspective view of a rigidizer arm is shown that can be used with the cushion of FIG. 5A or the cushion of FIG. 5B .

[0147] FIG. 5E A perspective view of a headgear strap is shown that can be used with the cushion of FIG. 5A .

[0148] FIG. 5F A perspective view of a headgear strap is shown that can be used with the cushion of FIG. 5B .

[0149] FIG. 5G A front view of a pair of sleeves is shown that are removably fitted to the tube of FIG. 5C or the rigidizer arm of FIG. 5D .

[0150] FIG. 5H A front view of a pair of sleeves is shown that are removably fitted toFIG. 5D Front view of complete sleeve on hardener arm of

[0151] FIG. 5I Illustrates removable assembly of FIG. 5D Front perspective view of yet another alternative form of complete sleeve on hardener arm of

[0152] FIG. 5J Patient wearing a headgear strap connected to FIG. 5C Tube of FIG. 5E Headgear strap of FIG. 5G Sleeve of FIG. 5A Pillow of

[0153] FIG. 5K Patient wearing a hardener arm connected to FIG. 5D Hardener arm of FIG. 5E Headgear strap of FIG. 5H Sleeve of FIG. 5A Pillow of

[0154] FIG. 5L Patient wearing a catheter headgear connected to FIG. 5C Catheter headgear of FIG. 5B Pillow of FIG. 5F Headgear strap of

[0155] FIG. 5M Patient wearing a hardener arm connected to FIG. 5D Hardener arm of FIG. 5F Headgear strap of FIG. 5I Sleeve of FIG. 5B Pillow of

[0156] FIG. 5N Isolated perspective view of vent of FIG. 5L

[0157] Isolated perspective view of a portion of air circuit of FIG. 5O FIG. 5M Is a schematic diagram illustrating possible combinations of patient interfaces.

[0158] FIG. 5P Is a schematic diagram illustrating a medical system in accordance with aspects of the present disclosure.

[0159] FIG. 6 Illustrates a schematic diagram of a medical system in accordance with aspects of the present disclosure.

[0160] FIG. 7A And 7B Illustrates perspective view ( ) and side cross-sectional view ( ) of an exemplary flexible circuit board. FIG. 7A FIG. 7B

[0161] FIG. 8A And 8B ​​​A perspective view of an optional example flexible circuit board is shown. FIG. 8A ) and a side cross-sectional view ( FIG. 8B ).

[0162] FIG. 8C A side cross-sectional view of an optional example flexible circuit board is shown.

[0163] FIGS. 9A-9C A perspective view of an optional example flexible circuit board ( FIG. 9A ) and an example protrusion ( FIGS. 9B-9C ) is shown.

[0164] FIG. 10A and 10B A perspective view of an optional example flexible circuit board ( FIG. 10A ) and a side cross-sectional view ( FIG. 10B ) is shown.

[0165] FIGS. 10C-10E A perspective cross-sectional view of an example via is shown.

[0166] FIG. 11 An example packaging circuit board is shown.

[0167] FIG. 12 A flowchart of an example method of forming FIG. 11 the packaging circuit board shown is shown.

[0168] FIG. 13 is a side view of another packaging board.

[0169] FIG. 14A and 14B A front view ( FIG. 14A ) and a side view ( FIG. 14B ) of an example patient interface in accordance with aspects of the present disclosure is shown.

[0170] FIG. 15A and 15B A rear view ( FIG. 15A ) and a top view ( FIG. 15B ) of an optional example patient interface is shown.

[0171] FIG. 16A and 16B A perspective cross-sectional view ( FIG. 16A ) and a front cross-sectional view ( FIG. 16B ) of an example headgear tube is shown.

[0172] FIG. 17A and 17B A perspective cross-sectional view ( FIG. 17A ) and a front cross-sectional view ( FIG. 17B ) of an example headgear tube is shown.

[0173] FIG. 18 A perspective view of a headgear tube in an example embodiment in accordance with aspects of the present disclosure is shown.

[0174] FIG. 19 A perspective view of a headgear tube in an example embodiment in accordance with aspects of the present disclosure is shown.

[0175] FIG. 20 An example configuration of an antenna and tag in use in accordance with aspects of the present disclosure is shown. 5DETAILED DESCRIPTION

[0177] Before describing the present technology in further detail, it is to be understood that the technology is not limited to the specific examples described herein, which can vary. It is also to be understood that the terminology used in the present disclosure is for the purpose of describing particular examples only and is not intended to be limiting.

[0178] The following description is provided in relation to various examples which can share one or more common characteristics and / or features. It should be understood that one or more features of any one example can be combinable with one or more features of another example or other examples. Additionally, any single feature or combination of features in any of the examples can constitute additional examples.

[0179] Reference will now be made in detail to aspects of the present disclosure, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or like reference numbers will be used throughout the drawings to refer to same or like parts. The term "distal" refers to the portion that is farthest from the user (e.g., patient). Conversely, the term "proximal" refers to the portion that is closest to the user.

[0180] The foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the features claimed. As used herein, the terms "comprises," "comprising," "includes," "including," "has," "having," 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 can include other elements not expressly listed or inherent to such process, method, article, or apparatus. In this disclosure, relative terms, such as "about," "substantially," "generally," and "approximately" are used to indicate a possible variation of ±10% of the stated value or characteristic.

[0181] 5.1 Treatment

[0182] In one form, the present technology comprises a method for treating a respiratory disorder, the method comprising applying positive pressure to the entrance of the airways of a patient 1000.

[0183] In certain examples of the present technology, an air supply at positive pressure is provided to the nasal passages of a patient via one or both nares.

[0184] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.

[0185] 5.2 Respiratory therapy system

[0186] In one form, the present technology comprises a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system can comprise an RPT device 4000 for supplying a flow of air to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0187] FIG. 1A A respiratory therapy system is shown comprising a patient 1000 wearing a patient interface 3000 in the form of a nasal pillow 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.

[0188] FIG. 1B An alternative configuration of a respiratory therapy system is shown comprising 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 RPT device is humidified in a humidifier 5000 and passes along an air circuit 4170 to the patient 1000.

[0189] FIG. 1C Another alternative configuration of a respiratory therapy system is shown comprising a patient 1000 wearing a patient interface 3000 in the form of a full face 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.

[0190] An RPT device 4000 according to an aspect of the present technology comprises mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300, for example any of the whole or part of the methods described herein. The RPT device 4000 can be configured to generate a flow of air for delivery to the airways of a patient, for example for treating one or more respiratory conditions described elsewhere in this document.

[0191] In one form, the RPT device 4000 is constructed and arranged to be capable of delivering a flow of air in the range -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH20, or at least 10 cmH20, or at least 20 cmH20.

[0192] As FIG. 1A , 1BAs shown in 1C, the patient 1000 can use the respiratory therapy system in various positions. Thus, the position of the patient interface 3000, for example, relative to the air circuit 4170 or other aspects of the respiratory therapy system, can vary throughout use.

[0193] 5.3 Patient Interface

[0194] According to one aspect of the present technology, as FIG. 2 The non-invasive patient interface 3000, as shown, includes the following functional aspects: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilising structure 3300, a vent 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, a functional aspect can be provided by one or more physical components. In some forms, one physical component can provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround an entrance to a patient's airways so as to maintain positive pressure at the entrance to the patient's airways. Thus, the sealed patient interface 3000 is suitable for delivery of positive pressure therapy.

[0195] 5.3.1 Cushion Surface

[0196] FIG. 3A An exemplary seal-forming structure (e.g., cushion) for a mask including two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The domed and saddle regions are indicated.

[0197] FIG. 3B An alternative exemplary seal-forming cushion for a mask is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. A path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle regions and a domed region are indicated.

[0198] As FIG. 3A and 3B shown, the outer surface of each exemplary cushion includes various positive and negative curvatures, resulting in a complex three-dimensional shape. For example, the domed regions shown can include negative curvature. The saddle regions shown can include positive and negative curvature. The cushion can include multiple domed and saddle regions. Furthermore, the cushion can be constructed of a soft, pliable material that is able to conform to the patient's face or nasal passages. In this way, the positive and negative curvatures of the cushion can change during use. For example, the domed and / or saddle regions can become more or less pronounced.

[0199] As FIG. 3C shown, the surface can have one-dimensional holes, for example holes bounded by planar curves or by spatial curves. A thin structure (e.g., a membrane) with holes can be described as having one-dimensional holes. See, for example, FIG. 3COne-dimensional holes in a surface of a structure bounded by planar curves. One-dimensional holes can be formed on one or more aspects of the respiratory therapy systems described herein. For example, one-dimensional holes can be formed on any thin planar structure of a respiratory therapy system.

[0200] As FIGS. 3F-3H illustrated, a structure can have two-dimensional holes, e.g., holes bounded by surfaces. For example, a pneumatic tire has two-dimensional holes bounded by the inner surface of the tire. In another example, a bladder having a cavity for air or gel can have two-dimensional holes. See, e.g., the cushion of FIG. 3F and the exemplary cross-sections through FIG. 3G and FIG. 3H illustrating the inner surfaces bounding the two-dimensional holes.

[0201] FIG. 3D illustrates a cross-section through a structure of FIG. 3C . The illustrated surfaces bound two-dimensional holes in the structure of FIG. 3C .

[0202] In yet another example, a conduit can include a one-dimensional hole (e.g., at its inlet or at its outlet) and a two-dimensional hole bounded by an inner surface of the conduit. See also the two-dimensional hole bounded by the illustrated surface in the structure of FIG. 3E .

[0203] FIG. 3E illustrates a perspective view of a structure of FIG. 3C including a two-dimensional hole and a one-dimensional hole. Also illustrated are surfaces bounding the two-dimensional hole in the structure of FIG. 3C .

[0204] FIG. 3F illustrates a mask having an inflatable bladder as a cushion.

[0205] FIG. 3G and 3H illustrates a cross-section of the mask of FIG. 3F . For example, FIG. 3G illustrates a first cross-section through the mask of FIG. 3F and illustrates an inner surface of the bladder. The inner surface bounds a two-dimensional hole in the mask. FIG. 3H illustrates a second cross-section through the mask of FIG. 3F . Also indicated is an inner surface. As FIG. 3G and 3H illustrate, an inner surface of a mask cushion can have a complex three-dimensional shape. The inner surface of a cushion can also change shape during use. For example, the curvature of an inner surface can become more or less pronounced as the cushion conforms to a patient’s face.

[0206] 5.3.2 Inflatable Chambers

[0207] Referring back toFIG. 2 In use, the plenum chamber 3200 has a periphery shaped to complement the surface contours of an average human face in the region where a seal is formed. In use, the bounding edges of the plenum chamber 3200 are positioned in close proximity to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 can extend around the entire periphery of the plenum chamber 3200 in use. In some forms, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single sheet of homogenous material.

[0208] In certain forms of the technology, the plenum chamber 3200 does not cover the eyes of the patient in use. In other words, these are outside the pressurised 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.

[0209] In certain forms of the technology, the plenum chamber 3200 is constructed from a transparent material, for example, 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 assist a clinician to observe how the patient interface is positioned and functioning.

[0210] In certain forms of the 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.

[0211] In some forms, the plenum chamber 3200 is constructed from a rigid material, such as polycarbonate. The rigid material can provide support to the seal-forming structure.

[0212] In some forms, the plenum chamber 3200 is constructed from a flexible material (for example, from a soft, flexible, elastomeric material such as silicone, fabric, foam, or the like). For example, in an example, it can be formed from a material having a Young’s modulus of 0.4 GPa or less, for example, a foam. In some forms of the technology, the plenum chamber 3200 can be made from a material having a Young’s modulus of 0.1 GPa or less, for example, a rubber. In other forms of the technology, the plenum chamber 3200 can be made from a material having a Young’s modulus of 0.5 MPa or less, for example, between 0.5 MPa and 0.3 GPa. One example of such a material is silicone.

[0213] 5.3.2.1 Multi-opening

[0214] As FIG. 5A And 5BAs shown, different air chambers 3200-1, 3200-2 can be formed as part of multi-opening liners 3050-1, 3050-2. In the example shown, liners 3050-1, 3050-2 each include three openings, although alternative liners may be formed with more or fewer openings.

[0215] In some forms, different openings can serve different purposes. For example, some openings may be solely entrance openings, while others may be solely exit openings.

[0216] In other forms, at least one opening can provide two different functions. For example, during the same respiratory cycle, one opening can serve as both an inlet and an outlet.

[0217] These multiple openings allow for various configurations of air delivery into the inflation chambers 3200-1 and 3200-2. For example, depending on the patient's needs and / or comfort, the patient can use a given liner 3050-1 or 3050-2 in a "tube-up" configuration (e.g., using a catheter head described below) or a "tube-down" configuration (e.g., using a single catheter in front of the patient's face).

[0218] 5.3.2.1.1 Nose and mouth mask

[0219] like FIG. 5A As shown, the inflation chamber 3200-1 includes a pair of inflation chamber inlets 3254-1, which can be used to deliver gas into and / or discharge gas from the inflation chamber 3200-1. The inflation chamber inlet ports 3254-1 may be arranged on opposite sides of the inflation chamber 3200-1 (e.g., left and right sides).

[0220] In some forms, the air chamber 3200-1 may also include at least one vent opening 3402-1 (see example...) FIG. 5A Ventilation opening 3402-1 is located at the center of inflation chamber 3200-1. For example, ventilation opening 3402-1 may be located between inlet ports 3254-1 of the inflation chamber.

[0221] In some forms, the inflation chamber 3200-1 may include a pair of recesses 3266-1. Each recess 3266-1 may be located near one of the inflation chamber inlet ports 3254-1. Each recess 3266-1 may form a partially recessed surface.

[0222] 5.3.2.1.2 Nose mask only

[0223] Only the air chamber 3200-2 of the nasal pad 3050-2 can be similar to the air chamber 3200-1 of the mouth and nose pad 3050-1. The following describes only some similarities and differences between the air chambers 3200-1 and 3200-2.

[0224] like FIG. 5B As shown, the inflation chamber 3200-2 includes a pair of inflation chamber inlets 3254-2, which can be used to deliver gas into the inflation chamber 3200-2 and / or discharge gas from the inflation chamber 3200-1. The inflation chamber inlet ports 3254-2 may be arranged on opposite sides of the inflation chamber 3200-2 (e.g., left and right sides).

[0225] In some forms, the air chamber 3200-2 may also include at least one vent opening 3402-2 (see example...) FIG. 5B Ventilation opening 3402-2 is located at the center of inflation chamber 3200-2. For example, ventilation opening 3402-2 can be located between inflation chamber inlet ports 3254-2.

[0226] In some forms, the inflation chamber 3200-2 may include a pair of recesses 3266-2. Each recess 3266-2 may be located near one of the inflation chamber inlet ports 3254-2. Each recess 3266-2 may form a partially recessed surface.

[0227] 5.3.3 Positioning and Stabilizing Structure

[0228] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0229] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilization structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilization structure 3300 includes at least one strip having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strip.

[0230] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying down in a supine sleeping position, wherein the back area of ​​the patient's head rests on a pillow.

[0231] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying on the pillow in a side-sleeping position with the side of the patient's head on the pillow.

[0232] In one form of the present technology, the positioning and stabilising structure 3300 is provided with a decoupling portion between a front portion of the positioning and stabilising structure 3300 and a rear portion of the positioning and stabilising structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible or soft strap. The decoupling portion is constructed and arranged so that when a patient lies on a pillow with their head, the presence of the decoupling portion prevents forces acting on the rear portion from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.

[0233] In one form of the present technology, the positioning and stabilising structure 3300 comprises a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer and a fabric outer layer. In one form, the foam is porous to enable moisture (e.g. sweat) to pass through the strap. In one form, the fabric outer layer comprises loop material for partial engagement with hook material.

[0234] In certain forms of the present technology, the positioning and stabilising structure 3300 comprises a strap that is extendable, for example elastically extendable. For example, the strap can be configured to be in tension when in use and to direct forces to pull the seal forming structure into sealing contact with a portion of the patient's face. In one example, the strap can be configured as a tie.

[0235] In one form of the present technology, the positioning and stabilising structure comprises a first tie configured and arranged so that in use at least a portion of a lower edge of the first tie passes over a point of the patient's head above the ear and covers a portion of the parietal bone without covering the occipital bone.

[0236] In one form of the present technology suitable for use with a nasal only mask or a full face mask, the positioning and stabilising structure comprises a second tie configured and arranged so that in use at least a portion of an upper edge of the second tie passes below a point of the patient's head below the ear and covers or is located below the occipital bone of the patient's head.

[0237] In one form of the present technology suitable for use with a nasal only mask or a full face mask, the positioning and stabilising structure comprises a third tie configured and arranged to interconnect the first tie and the second tie to reduce the tendency of the first tie and the second tie to separate from each other.

[0238] In certain forms of the present technology, the positioning and stabilising structure 3300 comprises a strap that is flexible and, for example, non-rigid. An advantage of this aspect is that the strap is more comfortable for a patient to lie on when sleeping.

[0239] In certain forms of the present technology, the positioning and stabilising structure 3300 comprises a strap that is constructed to be breathable to allow moisture to be transmitted through the strap.

[0240] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilising structure 3300, each configured to provide a retention force to correspond to a different size and / or shape range. For example, the system can include one form of positioning and stabilising structure 3300 that is suitable for a large size head but not a small size head, and another form of positioning and stabilising structure that is suitable for a small size head but not a large size head.

[0241] 5.3.3.1 CANNULA HEADSET

[0242] 5.3.3.1.1 CANNULA HEADSET TUBE

[0243] In some forms of the present technology, the positioning and stabilising structure 3300 includes one or more headset 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 the seal-forming structure 3100. In FIG. 5J In the illustrated form of the present technology, the positioning and stabilising structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the plenum chamber 3200. The tubes 3350 are configured to position and stabilise the seal-forming structure 3100 of the patient interface 3000 in use on appropriate parts of the patient’s face (e.g. the nose and / or mouth). This allows the conduit of the air circuit 4170 that provides the flow of pressurised air to be connected to a connection port 3600 of the patient interface that is located differently from the front of the patient’s face, for example on the top of the patient’s head.

[0244] In FIG. 5J In the illustrated form of the present technology, the positioning and stabilising structure 3300 includes two tubes 3350, each of which in use is located on a different side of the patient’s head and extends over the respective ear (above the otobasion superior on the top of the patient’s head) through the respective cheek area to a elbow tube 3610 on the top of the patient’s 1000 head. This form of technology can be advantageous because if the patient is sleeping on their 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 examples of the technology, the patient interface 3000 can include a different number of tubes, for example one tube, or two or more tubes.

[0245] In one example in which the patient interface has one tube 3350, the single tube 3350 is positioned in use on one side of the patient’s head (e.g. across one cheek region) and the strap forms part of the positioning and stabilising structure 3300 and is positioned in use on the other side of the patient’s head (e.g. across the other cheek region) to help secure the patient interface 3000 to the patient’s head. For example, the tube 3350 and the strap can each be under tension in use to help maintain the seal-forming structure 3100 in the sealing position.

[0246] In one form, the tube 3350 can be at least partially extendable, such that the tube 3350 and the strap can be adjusted to substantially equal lengths when worn by the patient. This can allow for substantially symmetrical adjustment between the tube 3350 and the strap, such that the seal-forming structure substantially remains in the middle.

[0247] In FIG. 5J In the illustrated form of the technology, the two tubes 3350 are fluidly connected to each other and to the connection port 3600 at the upper end. In some examples, the two tubes 3350 are integrally formed, while in other examples the tubes 3350 are separately formed but are connected in use and can be disconnected, for example for cleaning or storage. Where separate tubes are used, they can be indirectly connected together, for example each can be connected to a T-connector. The T-connector can have two arms / branches, each of which can be fluidly connected to a respective one of the tubes 3350. In addition, the T-connector can have a third arm or opening that provides the connection port 3600 for fluid connection to the air circuit 4170 in use. The opening can be an inlet 3332 (see, for example, 5C) for receiving a flow of pressurised air.

[0248] In some forms, the third arm of the T-connector can be substantially perpendicular to each of the first two arms.

[0249] In some forms, the third arm of the T-connector can be obliquely formed relative to each of the first two arms.

[0250] In some forms, a Y-connector can be used instead of a T-connector. The first two arms can be oblique relative to each other, and the third arm can be oblique relative to the first two arms. The angled formation of the first two arms can be similar to the shape of the patient’s head so as to conform to that shape.

[0251] In some forms, at least one arm of the T-connector (or Y-connector) can be flexible. This can allow the connector to flex based on the shape of the patient’s head and / or the forces in the positioning and stabilising structure 3300.

[0252] In some forms, at least one arm of the T-connector (or Y-connector) can be at least partially rigidized. This helps to maintain the shape of the connector so that bending of the connector does not occlude the air flow path.

[0253] Tubes 3350 can be formed of a flexible material, such as an elastomer, e.g., silicone or TPE, and / or one or more fabrics and / or foam materials. Tubes 3350 can have a pre-shaped shape and be able to bend or move into another shape when a force is applied, but can return to the original pre-shaped shape when the force is removed. Tubes 3350 can generally be arcuate or curved, with a shape approximating the head contour between the top of the patient’s head and the nasal or oral region.

[0254] In some examples, the one or more tubes 3350 are crush resistant to resist being clogged if crushed during use, e.g., if crushed between the patient’s head and a pillow, especially if there is only one tube 3350. Tubes 3350 can be formed with sufficient structural rigidity to resist crushing, or can be as described in U.S. Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0255] Each tube 3350 can be configured to receive an air flow from a connection port 3600 on the top of the patient’s head and deliver the air flow to the seal-forming structure 3100 at the patient’s airway entrance. In the illustrated example, each tube 3350 is configured to receive air flow from a connection port 3600 on the top of the patient’s head and deliver the air flow to the seal-forming structure 3100 at the patient’s airway entrance. FIG. 5J In the illustrated example, each tube 3350 is in use located on a path that extends from the plenum chamber 3200 through the patient’s cheek region and over the patient’s ear to the elbow 3610. For example, a portion of each tube 3350 proximate the plenum chamber 3200 can cover the maxilla region of the patient’s head in use. Another portion of each tube 3350 can cover the region of the patient’s head superior to the patient’s otobasion superior. Each tube 3350 can also be located over the patient’s sphenoid and / or temporal bone and one or both of the patient’s frontal and parietal bone. The elbow 3610 can be located on the patient’s parietal bone, frontal bone, and / or the junction between them (e.g., the coronal suture) in use.

[0256] In certain forms of the present technology, the patient interface 3000 is configured so that the connection port 3600 can be positioned in a range of positions across the top of the patient’s head, such that the patient interface 3000 can be positioned for comfort or fit to the individual patient. In some examples, the headgear tube 3350 is configured to allow the upper portion of the patient interface 3000 (e.g. the connection port 3600) to move relative to the lower portion of the patient interface 3000 (e.g. the plenum chamber 3200). That is, the connection port 3600 can be at least partially decoupled from the plenum chamber 3200. In this way, the seal-forming structure 3100 can form an effective seal with the patient’s face regardless of the position of the connection port 3600 on the patient’s head (at least within a predetermined range of positions).

[0257] As mentioned above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a nasal pillow that sits generally below the nose and seals to the lower perimeter of the nose (e.g. a sub-nasal pillow). The positioning and stabilising structure 3300 (including the tube 3350) can be constructed and arranged to pull the seal-forming structure 3100 under the patient’s nose with a sealing force in a posterior and superior direction (e.g. a postero-superior direction). The sealing force with the postero-superior direction can cause the seal-forming structure 3100 to form a good seal to the lower perimeter of the patient’s nose and to the forward-facing surface of the patient’s face, for example on either side of the patient’s nose and the patient’s lip.

[0258] 5.3.3.1.2 Extensible and non-extensible tube portions

[0259] In some examples of the present technology, one or both of the tubes 3350 are non-extensible in length. However, in some forms, the tubes 3350 can include one or more extensible tube sections, for example formed of an extensible accordion structure. In some forms, the patient interface 3000 can include a positioning and stabilising structure 3300 that includes at least one gas delivery tube that includes a tube wall having an extensible accordion structure. FIG. 5J The patient interface 3000 shown in FIG. 5.3.3.1.1 includes tubes 3350, the upper portions of which include extensible tube sections, each in the form of an extensible accordion structure 3362.

[0260] In some forms, the extendable concertina structure 3328 can be formed as a series of ridges and grooves on the surface of the tube 3350. The concertina structure 3328 can be biased towards a retracted position, and can be moved to an extended position when the patient is positioned prone and the positioning and stabilising structure 3300 is in use. Because portions of the tube 3350 can be substantially non-extensible (e.g. non-extensible tube segments 3363), the concertina structure 3328 allows the positioning and stabilising structure 3300 to stretch in order to fit different sized heads. This can allow a single size of tube 3350 to be used with multiple sizes of head. For example, as a result of the concertina structure 3328, the positioning and stabilising structure 3300 can be “one size fits all”. Alternatively, the tube 3350 can be manufactured in multiple sizes (e.g. small, medium, large). The patient can select the length that most closely fits their head, and the concertina structure 3328 can be adjusted slightly in order to fit the individual patient.

[0261] In some forms, the inlet 3332 can be disposed in the middle of the conduit 6320. For example, the tube 3350 can be symmetrical about the inlet 3332 through at least one axis.

[0262] The cross-sectional shape of the non-extensible tube segments 3363 of the tube 3350 can be circular, oval, ovoid, D-shaped, or rounded rectangular, for example as described in US Patent No. 6,044,844. Cross-sectional shapes that present a flat surface of the tube on the side that faces and contacts the patient’s face or other part of the head can be more comfortable to wear than, for example, tubes with circular cross-sections.

[0263] In some examples of the present technology, the non-extensible tube segments 3363 connect to the plenum chamber 3200 from a low angle. The headgear tube 3350 can extend down the side of the patient’s head, then curve forward and medially to connect to the plenum chamber 3200 in front of the patient’s face. The tube 3350 extends to a position that is the same vertical position as (or in some examples, below) the connection to the plenum chamber 3200, before connecting to the plenum chamber 3200. That is, the tube 3350 can protrude in at least a partially upward direction before connecting to the plenum chamber 3200. A portion of the tube 3350 can be located below the plenum chamber 3200 and / or the seal-forming structure 3100. The tube 3350 can contact the patient’s face below the patient’s cheekbones, which can be more comfortable than contacting the patient’s cheekbones, and can avoid obscuring the patient’s peripheral vision excessively.

[0264] 5.3.3.1.3 Conduit headgear connection port

[0265] In certain forms of the present technology, the patient interface 3000 can include a connection port 3600 located near the upper, side or rear of the patient’s head. For example, in FIG. 5JIn the form of the technology shown, the connection port 3600 is located at the top of the patient’s head (e.g. in an upper position relative to the patient’s head). In this example, the patient interface 3000 includes an elbow 3610 that forms the connection port 3600. The elbow 3610 can be configured to be in fluid connection with the conduit of the air circuit 4170. The elbow 3610 can be configured to rotate relative 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 is configured to rotate by rotation about a substantially vertical axis, and in some specific examples, by rotation about two or more axes. In some examples, the elbow can include or be connected to the tube 3350 by a ball and socket joint. The connection port 3600 can be located in the sagittal plane of the patient’s head when in use.

[0266] Patient interfaces having connection ports that are not located in front of the patient’s face can be advantageous as some patients can find conduits of patient interfaces that are connected to the front of their face to be unattractive and / or obtrusive. For example, conduits of patient interfaces that are connected to the front of the patient’s face can be prone to interfering with bed linen or bed sheets, particularly if the conduit extends downward from the patient interface when in use. Forms of the technology that include patient interfaces having connection ports that are located above the patient’s head when in use can make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: a side sleeping position, a supine position (e.g. on their back, generally facing upwards) or in a prone position (e.g. on their front, generally facing downwards). Furthermore, connecting the conduit to the front of the patient interface can exacerbate a problem known as tube drag, where the conduit exerts an unwanted force on the patient interface during patient head or conduit movement, causing displacement away from the face. Tube drag can be a less of a problem when the force is experienced in an upper position of the patient’s head than when the force is experienced in front of the patient’s face proximate to the seal-forming structure (where tube drag can be more likely to break the seal).

[0267] 5.3.3.1.4 Headgear tube fluid connection

[0268] The two tubes 3350 are fluidly connected at their lower 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 a connection of two rigid connectors. The tubes 3350 and the plenum chamber 3200 can be configured to enable the patient to easily connect the two components together in a reliable manner. The tubes 3350 and the plenum chamber 3200 can be configured to provide tactile and / or audible feedback in the form of a “re- assurance click” or similar sound, so that the patient can easily know that each tube 3350 has been properly connected to the plenum chamber 3200. In one form, the tubes 3350 are formed of silicone or a textile material, and the lower end of each silicone tube 3350 is over-molded onto a rigid connector made of, for example, polypropylene, polycarbonate, nylon, or the like. The rigid connector on each tube 3350 can include 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 can include a male mating feature configured to connect to a female mating feature on the plenum chamber 3200. In other examples, the tubes 3350 can each include a male or female connector formed of a flexible material such as silicone or TPE, for example, with the tubes 3350 being formed of the same material.

[0269] In other examples, compression sealing 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 can 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 resiliency of the silicone pushes the tube 3350 outward to seal the tube 3350 in the port in an air-tight manner. Alternatively, in a hard-against-hard style joint between the tube 3350 and the plenum chamber 3200, each tube 3350 and / or the plenum chamber 3200 can include a pressure-activated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange can be urged against the joint between the tube and the circumferential surface of the port or connector of the plenum chamber 3200 to form or enhance the seal between the tube 3350 and the plenum chamber 3200.

[0270] 5.3.3.2 Headgear straps

[0271] In some forms, the positioning and stabilising structure 3300 can include a headgear 3302 having at least one strap that can be worn by the patient in order to help correctly orient the seal-forming structure 3100 against the patient’s face (e.g., in order to limit or prevent leaks).

[0272] As described above, some forms of the headgear 3302 may be made of fabric material that can comfortably fit against the patient's skin. The fabric can be flexible to conform to various facial contours. Although the fabric may include a hardener along a selected length, it can limit the bending, flexing, and / or stretching of the headgear 3302.

[0273] In some forms, the hood 3302 may be at least partially stretchable. For example, the hood 3302 may comprise an elastic or similar stretchable material. For example, the entire hood 3302 may be stretchable, or selected portions may be stretchable (or more stretchable than the surrounding portions). This allows the hood 3302 to stretch under tension, which may help provide a sealing force for the seal-forming structure 3100.

[0274] The two types of hoods, the four-point hood 3302-1 and the two-point hood 3302-2, are discussed in more detail below as illustrative examples.

[0275] 5.3.3.2.1 Four-point connection

[0276] like FIG. 5E As shown, some forms of the headgear 3302-1 can be a four-point connection headgear. This means that the headgear 3302-1 can be connected to four separate locations on the inflation chamber 3200, to the frame of the inflation chamber 3200, and / or to the arms of the inflation chamber 3200. The headgear 3302-1 may include four different straps that provide tension to help hold the sealing formation 3100 in the sealed position.

[0277] In some forms, the headgear 3302-1 may include a lower band 3304-1 that can be attached to the lower part of the padding 3050-1. The lower band 3304-1 may extend along the patient's cheek toward the back of the patient's head. For example, the lower band 3304-1 may cover the masseter muscle on either side of the patient's face. Thus, the lower band 3304-1 may contact the patient's head below the ear. The lower band 3304-1 may meet at the back of the patient's head and may cover the occipital bone and / or trapezius muscle.

[0278] The headgear 3302-1 may also include an upper band 3305-1 that may cover the temporal bone, parietal bone, and / or occipital bone. The upper band 3305-1 may also be connected to the tube 3350 (e.g., by connection to the flap 3320).

[0279] The posterior strap 3307-1 can extend between the superior strap 3305-1 and the inferior strap 3304-1. The inferior strap 3304-1 and the superior strap 3305-1 on a given side (e.g., left or right) can also be connected to the posterior strap 3307-1 adjacent to each other. Thus, the height of the posterior strap 3307-1 can be approximately the combined height of the inferior strap 3304-1 and the superior strap 3305-1. In use, the posterior strap 3307-1 can cover the occipital bone and / or the parietal bone. This can allow the posterior strap 3307-1 to help anchor the headgear 3302-1 to the patient’s head.

[0280] In the illustrated example, the headgear 3302-1 can be formed in a generally X-shape. The inferior straps 3304-1 and the superior straps 3305-1 can be connected to the posterior strap 3307-1 using stitching, ultrasonic welding, or any similar process.

[0281] In some forms, the inferior straps 3304-1 are connected to the magnetic members 3306-1. For example, each inferior strap 3304-1 can pass through the magnetic member 3306-1, such that the length of each inferior strap 3304-1 can be adjusted. The magnetic member 3306-1 can be removably connected to the magnet 3370-1 (described below), such that the inferior straps 3304-1 can be disconnected from the plenum chamber 3200, but the length of the inferior straps 3304-1 can not be affected.

[0282] In some forms, the superior straps 3305-1 can be directly connected to the tabs 3320 of the tube 3350. The superior straps 3305-1 can pass through the tabs 3320 to adjust the length and control the tension of each superior strap 3305-1.

[0283] In some forms, the headgear 3302-1 can only be used with the nasal mask 3050-1 (e.g., because the nasal mask 3050-1 does not have four connection points). However, the headgear 3302-1 can be used interchangeably with the tube 3350 and the rigidifier arms 3340.

[0284] 5.3.3.2.2 Two-point connection

[0285] As FIG. 5F illustrated, some forms of the headgear 3302-2 can be a two-point connection headgear. This means that the headgear 3302-2 can be connected to two separate locations.

[0286] In some forms, the headgear 3302-2 can be formed from a continuous piece of material. In other words, the headgear 3302-2 can not be formed from multiple straps that are connected (e.g., stitched) together. This can be comfortable for the patient because they are not in contact with any seams or joints that connect the different straps. In other forms, the headgear 3302-2 can be formed from multiple straps (e.g., two superior straps, a posterior strap, etc.) that are connected together (e.g., by stitching, ultrasonic welding, etc.).

[0287] In some forms of this technology, the positioning and stabilizing structure 3300 includes at least one headband that, in addition to the tube 3350, is used to position and stabilize the sealing forming structure 3100 at the patient's airway inlet. For example... FIG. 5F As shown, the patient interface 3000 includes a posterior strap 3307-2 forming part of a positioning and stabilizing structure 3300. For example, the posterior strap 3307-2 may be referred to as a back strap or a hood strap. The posterior strap 3307-2 may cover the temporal bone, parietal bone, and / or occipital bone. In other examples of the present technology, one or more additional straps may be provided. For example, an example of a patient interface 3000 with a nose and mouth pad according to the present technology may have a second lower strap configured to abut against the patient's head near the patient's neck and / or against the posterior surface of the patient's neck.

[0288] like FIG. 5F As shown, some forms of the headgear 3302-2 can be at least partially bifurcated. For example, the rear band 3307-2 of the headgear 3302-2 (e.g., configured to contact the back of the patient's head) can be wider than the surrounding portion of the headgear 3302-2. The middle portion 3308-2 of the rear band 3307-2 may include a slit 3309-2. Thus, due to the slit 3309-2, the upper section of the rear band 3307-2 can move relative to the lower section. This can allow for greater band coverage over the back area of ​​the patient's head, which can help to better anchor the headgear 3302-2 to the patient's head, since there is no lower band (e.g., 3304-1).

[0289] In some configurations, the headgear 3302-2 may be used only with the nose pad 3050-2 (for example, because the nose pad 3050-1 does not have four connection points). However, the headgear 3302-2 may be used interchangeably with the tube 3350 and the hardener arm 3340.

[0290] 5.3.3.3 Hardener Arm

[0291] like FIG. 5D As shown, the hardening arm 3340 may be an elongated, rigid member that helps hold the pad (e.g., nasal pad 3050-1 or nasal pad 3050-2) in the operating position. The hardening arm 3340 may contact one side of the patient's head and provide force to limit the sliding of the seal-forming structure 3100 from the patient's nose and / or mouth.

[0292] In some forms, the hardener arm 3340 is made of a rigid material (e.g., plastic). Rigid materials may not allow the hardener arm 3340 to be stretched.

[0293] In some forms, the stiffener arm 3340 can be flexible in at least one direction. For example, the stiffener arm 3340 can be flexible in its width, while being inflexible in its length. In other words, the stiffener arm 3340 can bend about an axis along the width of the stiffener arm 3340, but cannot bend about an axis perpendicular to the stiffener arm 3340. This can allow an individual patient to adjust the stiffener arm 3340 in order to better fit their individual head.

[0294] In certain forms, the stiffener arm 3340 can hold in a new position after being bent. This can allow a patient to adjust the shape of the stiffener arm 3340 for their particular head, and then the stiffener arm 3340 will hold the desired shape in use in order to improve the patient’s comfort.

[0295] In some forms, the first end 3342 of the stiffener arm 3340 can be a free end, while the second end 3344 of the stiffener arm 3340 (e.g., opposite the first end 3342) can be fixed. The first end 3342 can be curved in order to minimize sharp edges that can cause discomfort to a patient. In use, the first end 3342 can also cover the patient’s head adjacent to the temporal bone. The second end 3344 can be fixed to the arm connection structure 3504.

[0296] In some forms, the arm connection structure 3504 can be similar to the conduit connection structure 3500. For example, the arm connection structure 3504 and the conduit connection structure 3500 can have substantially the same shape. This can allow the conduit connection structure 3500 or the arm connection structure 3504 to fit into a groove (e.g., 3266-1 or 3266-2) and connect to the plenum inlet port 3254. The arm connection structure 3504 can connect to the nasal cushion 3050-1 or the nasal cushion only 3050-2 in substantially the same manner as the conduit connection structure 3500 (e.g., via a snap fit, a press fit, a friction fit, etc.).

[0297] In some forms, the arm connection structure 3504 can act as a plug for the plenum inlet port 3254 (e.g., 3254-1 and / or 3254-2). Unlike the tube 3350, the stiffener arm 3340 does not convey pressurized air to the plenum 3200. The stiffener arm 3340 can be used with a “tube down” configuration, where a hose is connected to the vent opening 3402 (e.g., 3402-1 and / or 3402-2) and air is delivered through the vent opening 3402 into the plenum 3200. In this example, air does not need to travel into or out of the plenum inlet port 3254. Thus, the arm connection structure 3504 can form a seal with the plenum inlet port 3254 in order to limit airflow into or out of the plenum 3200.

[0298] 5.3.4 Vent

[0299] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow washout of exhaled gases, such as carbon dioxide.

[0300] In certain forms, the vent 3400 is configured to allow a continuous vent flow from an interior of the plenum chamber 3200 to ambient, while the pressure within the plenum chamber is positive relative to ambient. The vent 3400 is configured such that the vent flow has a magnitude sufficient to reduce rebreathing of exhaled C02 by the patient, while maintaining the therapeutic pressure in the plenum chamber in use.

[0301] One form of vent 3400 according to 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.

[0302] The vent 3400 can be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure (e.g., swivel).

[0303] As shown in FIG. 5N , a vent 3450 can be used with the patient interface 3000. The vent 3450 can have a substantially similar shape to the vent opening 3402-1 (e.g., a substantially circular shape).

[0304] The vent 3450 can be used with a mouth-nose plenum chamber 3200-1 (e.g., as shown in FIG. 5A ) or with a nasal only plenum chamber 3200-2 (e.g., as shown in FIG. 5B ).

[0305] With continued reference to FIG. 5A , the vent 3450 can include a vent housing 3404, which can be configured to engage with the vent opening 3402. The vent housing 3404 can be constructed from a rigid material or a semi-rigid material. For example, the vent housing 3404 can be constructed from a plastic, a metal, or any similar material. The vent housing 3404 can increase the rigidity of the patient interface 3000 (e.g., to limit unwanted bending that can affect the position of the seal-forming structure 3100 on the patient’s face).

[0306] The vent housing 3404 can include a front surface 3408, a rear surface 3412, and a recess 3416. The front surface 3408 faces away from the patient’s face in use, and can be located outside the pressurized volume of the plenum chamber 3200. The rear surface 3412 is arranged opposite the front surface 3408. In use, the rear surface 3412 can face the patient and can be arranged within the pressurized volume of the plenum chamber 3200. The recess 3416 can be formed between the front surface 3408 and the rear surface 3412. A portion of the plenum chamber 3200 can be received within the recess 3416 in order to hold the vent 3400 in place.

[0307] In some forms, a diffuser 3448 can be used with the vent housing 3404. The diffuser 3448 can help limit the decibel output from any patient interface 3000 (or any other patient interface). In particular, the diffuser 3448 can help limit the decibel level associated with the air output (e.g., exhaled air) from the patient interface 3000, although the diffuser 3448 can limit the decibel level at any point in the patient interface.

[0308] In certain forms, the diffuser 3448 can diffuse and thus slow down the exhaust air exiting the plenum chamber 3200 and passing through the vent housing 3404. The diffuser 3448 can help avoid spitting and associated discomfort to the patient and / or bed partner (e.g., noise caused by spitting on pillows, bed linen, bedclothes, etc.).

[0309] In some forms, the diffuser can include a front surface 3456 that faces away from the patient in use. The outer diameter of the front surface 3456 can be less than the inner diameter of the vent housing 3404 proximate the front surface 3408. This can form a gap 3464 through which air can pass.

[0310] 5.3.5 Decoupling structures

[0311] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0312] 5.3.6 Modularity

[0313] As mentioned above, the cushion, headgear, and sleeve can be of different types, which can correspond to different uses (e.g., mouth breathing, nasal breathing, etc.). The patient or clinician can select certain combinations of the cushion, headgear, and sleeve in order to optimize the effectiveness of the therapy and / or the comfort of the individual patient. An example of such a modular design is described in PCT / SG2022 / 050777, filed on 28 October 2022, the entire contents of which are hereby incorporated by reference.

[0314] In some forms, different types of cushion, headgear, and sleeve can be used interchangeably with one another so as to form different combinations of the patient interface. This can be beneficial from a manufacturing perspective as fewer components can be used to create a greater variety of patient interfaces. Additionally or alternatively, the various combinations can allow a patient to change the type of patient interface without changing each component.

[0315] Air can be delivered to the patient in one of two main ways. In one example, the patient can receive a flow of pressurized air through a headgear tube 3350 (see, e.g., FIG. 1 1 A). This can be referred to as a "tube up" configuration, and can position the connection port at the top of the patient's head. In other examples, the patient can receive a flow of pressurized air through a conduit connected to the plenum chamber 3200. This can be referred to as a "tube down" configuration, with the air flow conduit located in front of the patient's face. Different patients are more comfortable with one type of air delivery than the other (e.g., due to the patient's sleep type). Thus, it can be beneficial to allow for the use of a single type of patient interface in either a "tube up" or "tube down" configuration. FIG. 5C 5J

[0316] The patient interface can be part of a modular assembly with various interchangeable components that a patient and / or clinician can swap out for a different type of one or more components. The following describes various combinations that can result from assembling different components together.

[0317] 5.3.6.1 Sleeve

[0318] In some forms, to allow for modularity, a sleeve can be used with the tube 3350 and / or the rigidizer arms 3340. The sleeve can at least partially surround the tube 3350 and / or the rigidizer arms 3340. As shown in FIG. 1 1 B, different shaped sleeves can be used, which can correspond to different types of positioning and stabilizing structures 3300. In some forms, the configuration of the sleeve can be customized to fit a particular user's face. For example, the sleeve can be configured in a relatively more posterior region of the patient's head. FIG. 5G to 5I

[0319] In some forms, the sleeve can be constructed of a comfortable material. For example, the sleeve can be constructed of a textile material, a foam material, or a combination of the two. The comfortable material can contact the patient in use, and can feel soft against the patient's skin so as to improve patient compliance.

[0320] The material can also be flexible so as to facilitate donning or doffing the sleeve from the tube 3350 or rigidizer arms 3340. For example, the material can allow the sleeve to bend to conform to the shape of the tube 3350 or conduit headgear or rigidizer arms 3340, which can vary depending on the shape of the individual patient's head. ​​​

[0321] In some forms, the sleeve can also be at least partially elastic (e.g., the material can allow the sleeve to stretch). The elastic material can help the sleeve stretch to fit around the tube 3350 or the stiffener arm 3340. The elastic material can then return to an initial position that conforms to the tube 3350 or the stiffener arm 3340 to limit sleeve slippage in use.

[0322] As described in more detail below, some forms of the sleeve can be specific to the stiffening element (e.g., the tube 3350 and / or the stiffener arm 3340). However, the sleeve can help the stiffening element be interchangeably connected with versions or types of the cushion (e.g., the mouth-nose cushion 3050-1, the nasal only cushion 3050-2, etc.).

[0323] 5.3.6.2 Catheter sleeve

[0324] As shown in FIG. 35, one example of a sleeve is a catheter sleeve 3351, which can be used with the tube 3350 described above. FIG. 5G As shown in FIG. 35, the catheter sleeve 3351 can include a curved shape similar to the shape of the tube 3350 shown in FIG. 34. The flexible material used to construct the catheter sleeve 3351 can allow the catheter sleeve 3351 to further curve to correspond to the shape of the tube 3350 (e.g., when worn by the patient).

[0325] FIG. 5G As shown in FIG. 35, the catheter sleeve 3351 can include a first or upper opening 3352. The upper opening 3352 can be disposed at one end of the catheter sleeve 3351. The upper opening 3352 can be an opening of a channel that extends along at least a portion of the catheter sleeve 3351. FIG. 5C As shown in FIG. 35, some forms of the catheter sleeve 3351 can also include a lower extension 3354. The lower extension 3354 can be positioned on an end of the catheter sleeve 3351 opposite the upper opening 3352. The catheter sleeve 3351 can be tailored to fit a particular user’s face. For example, the lower extension 3354 of the catheter sleeve 3351 can be configured in a relatively more rearward area or a forward area of the patient’s head.

[0326] Some forms of the lower extension 3354 can include a rigid or semi-rigid piece (e.g., within the catheter sleeve 3351). The rigid or semi-rigid piece can be constructed of a plastic material or similar material. Alternatively, the lower extension 3354 can be stiffened using manufacturing processes (e.g., stitching stiffening threads, flat knitting, using a thicker material).

[0327] FIG. 5G As shown in FIG. 35, some forms of the catheter sleeve 3351 can also include a lower extension 3354. The lower extension 3354 can be positioned on an end of the catheter sleeve 3351 opposite the upper opening 3352. The catheter sleeve 3351 can be tailored to fit a particular user’s face. For example, the lower extension 3354 of the catheter sleeve 3351 can be configured in a relatively more rearward area or a forward area of the patient’s head.

[0328] Some forms of the lower extension 3354 can include a rigid or semi-rigid piece (e.g., within the catheter sleeve 3351). The rigid or semi-rigid piece can be constructed of a plastic material or similar material. Alternatively, the lower extension 3354 can be stiffened using manufacturing processes (e.g., stitching stiffening threads, flat knitting, using a thicker material).

[0329] As shown in FIG. 35, some forms of the catheter sleeve 3351 can also include a lower extension 3354. The lower extension 3354 can be positioned on an end of the catheter sleeve 3351 opposite the upper opening 3352. The catheter sleeve 3351 can be tailored to fit a particular user’s face. For example, the lower extension 3354 of the catheter sleeve 3351 can be configured in a relatively more rearward area or a forward area of the patient’s head. FIG. 5G ​​As shown, some forms of the lower extension 3354 may include a connecting member 3356. In the example shown, the connecting member 3356 may be a magnet, although in other examples, the connecting member 3356 may be different types of connectors (e.g., mechanical fasteners, adhesives, hook and ring materials, etc.). The connecting member 3356 may also be positioned at one end of the lower extension 3354, although the connecting member 3356 may also be positioned anywhere along the lower extension 3354.

[0330] In some forms, the connecting member 3356 (e.g., a magnet) can be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the conduit sleeve 3351 is connected to the tube 3350 (see example...) FIG. 5J When connected to the lower band 3304-1, the magnet 3370-1 can be removably connected to the connecting member 3356 to provide tension.

[0331] 5.3.6.2.1 Four-point arm sleeve

[0332] like FIG. 5H As shown, another example of a sleeve is the four-point arm sleeve 3380, which can be used with the hardener arm 3340 described above.

[0333] like FIG. 5H As shown, the four-point arm sleeve 3380 may include similar components. FIG. 5D The curvature arm 3340 is shown in a curved shape. The flexible material used to construct the four-point arm sleeve 3380 allows the four-point arm sleeve 3380 to be further bent to correspond to the shape of the curvature arm 3340 (e.g., when worn by a patient and / or bent by a patient).

[0334] like FIG. 5H As shown, some forms of the four-point arm sleeve 3380 may include a lower extension 3384. The lower extension 3384 may be located at one end of the four-point arm sleeve 3380.

[0335] In the example shown, the shape and / or structure of the lower extension 3384 is substantially the same as that of the lower extension 3354. For example, the lower extension 3384 may be more rigid than the rest of the four-point arm sleeve 3380 (e.g., due to rigidification of the thread or rigid material).

[0336] like FIG. 5HAs shown, some forms of the lower extension 3384 may include a connecting member 3386. In the example shown, the connecting member 3386 may be a magnet, although in other examples, the connecting member 3386 may be different types of connectors (e.g., mechanical fasteners, adhesives, hook and ring materials, etc.). The connecting member 3386 may also be positioned at one end of the lower extension 3384, although the connecting member 3386 may also be positioned anywhere along the lower extension 3384.

[0337] In some forms, the connecting member 3386 (e.g., a magnet) can be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the four-point arm sleeve 3380 is connected to the hardener arm 3340 (see example...) FIG. 5K When connected to the lower band 3304-1, the magnet 3370-1 can be removably connected to the connecting member 3386 to provide tension.

[0338] like FIG. 5H As shown, the four-point arm sleeve 3380 may include a pair of tabs 3394, which may be similar to the tabs 3320 on the tube 3350. When a patient wears the four-point arm sleeve 3380, the tabs 3394 may be positioned on the patient's head at a position substantially the same as the position of the tabs 3320 when the patient wears the tube 3350.

[0339] 5.3.6.2.2 Two-point arm sleeve

[0340] like FIG. 5I As shown, another example of a sleeve is the two-point arm sleeve 3380-1, which can be used with the hardener arm 3340 described above.

[0341] In some forms, the two-point arm sleeve 3380-1 can be similar to the four-point arm sleeve 3380 described above. Only some similarities and differences are described below.

[0342] like FIG. 5I As shown, the two-point arm sleeve 3380-1 may include a lower opening 3388-1 located at one end of the two-point arm sleeve 3380-1. The lower opening 3388-1 may form an opening for a channel passing through the two-point arm sleeve 3380-1. In the example shown, the lower opening 3388-1 may open to the surface of the conduit sleeve 3380-1.

[0343] like FIG. 5I As shown, 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 tube 3350. When a patient wears the two-point arm sleeve 3380-1, the tabs 3394-1 may be positioned on the patient's head at a position substantially the same as the position of the tab 3320 when the patient wears the tube 3350.

[0344] 5.3.6.3 Assembled patient interfaces

[0345] As FIGS. 5J to 5M shown, the various elements described above can be combined into four different patient interfaces. Different patient interfaces can allow patients to use different types based on their individual comfort. The modularity of different elements (e.g., the ability to use for multiple types of patient interfaces) can simplify manufacturing and / or can allow patients to more easily switch between multiple types of patient interfaces.

[0346] 5.3.6.3.1 Nasal and oral mask tube up configuration

[0347] As FIG. 5J shown, a patient can wear cushion 3050-1 in a tube up configuration with tube 3350 and four point headgear 3302-1. This assembly can form a tube up nasal and oral patient interface 3000-1.

[0348] In some forms, a conduit sleeve can be used with tube 3350 in order to enable a patient to experience the "tube up" air delivery type with oral nasal cushion 3050-1. As described below, the conduit sleeve provides an additional connection location for connecting four point headgear 3302-1. However, other forms of connectors can be used in addition to or instead of the conduit sleeve.

[0349] In the illustrated example, the conduit sleeve can be connected to tube 3350 of positioning and stabilizing structure 3300. Tube 3350 (through conduit connection structure 3500) can be used to connect tube 3350 to cushion 3050-1. The conduit sleeve provides a magnet in order to connect to magnets 3370-1 of four point headgear 3302-1 (see, e.g., FIG. 5E ). Alternatively, different forms of connection can be used.

[0350] As FIG. 5J shown, four point headgear 3302-1 can be connected at four separate locations in order to provide tension that holds sealing locations of cushion 3050-1 on a patient's head.

[0351] For example, lower straps 3304-1 (e.g., via magnetic members 3306-1) can be removably connected to the magnets of the conduit sleeve. In use, each lower strap 3304-1 can contact a patient's cheek (e.g., covering the masseter muscle). Lower straps 3304-1 can also extend under a patient's ear.

[0352] 5.3.6.3.2 Nasal and oral mask tube down configuration

[0353] As FIG. 5KAs shown, the patient can wear the pad 3050-1 in a tube-down configuration with a rigid arm 3340 and a four-point headgear 3302-1. This assembly forms a tube-down nose and mouth patient interface 3000-2.

[0354] In some configurations, the catheter sleeve can be used in conjunction with the sclerotherapy arm 3340 to allow patients to experience a “tube-down” air delivery type with the mouth and nose pad 3050-1. As described below, the catheter sleeve provides additional connection points for attaching the four-point headgear 3302-1. However, other types of connectors besides the catheter sleeve may be used.

[0355] In the example shown, the conduit sleeve can be connected to the hardener arm 3340 of the positioning and stabilizing structure 3300. The hardener arm 3340 (via the conduit connection structure 3504) can be used to connect the hardener arm 3340 to the liner 3050-1. The conduit sleeve provides a magnet for connection to the magnet 3370-1 of the four-point head sleeve 3302-1 (see example). FIG. 5E Alternatively, different connection methods can be used.

[0356] like FIG. 5K As shown, the four-point headgear 3302-1 can be connected in four separate positions to provide tension for holding the pad 3050-1 in a sealed position on the patient's head.

[0357] For example, the lower band 3304-1 (e.g., via magnetic member 3306-1) can be removably attached to a magnet on the catheter sleeve. In use, each lower band 3304-1 can contact the patient's cheek (e.g., covering the masseter muscle). The lower band 3304-1 can also extend below the patient's ear.

[0358] 5.3.6.3.3 The nasal mask tube is configured upwards.

[0359] like FIG. 5L As shown, a patient can wear the liner 3050-2 in a tube-up configuration with a tube 3350 and a two-point headgear 3302-2. This assembly forms a tube-up nasal-only patient interface 3000-3. The catheter sleeve can be used with the tube 3350 and can provide additional patient comfort. The sleeve can be connected to the positioning and stabilizing structure 3300 on the liner 3050-2 without adding additional connection points. In the example shown, the tube 3350 of the positioning and stabilizing structure 3300 can be directly connected to the liner 3050-2.

[0360] like FIG. 5M As shown, the two-point headgear 3302-2 can be connected to the tab 3320 on the tube 3350 to provide tension for holding the pad 3050-2 in a sealed position on the patient's head.

[0361] 5.3.6.3.4 Tube over nose mask arrangement

[0362] As shown in FIG. 5M , a patient can wear a tube over nose mask arrangement 3050-2 with hardener arms 3340 and a two point headgear 3302-2. This assembly can form a tubular down only nasal patient interface 3000-4.

[0363] A conduit sleeve can be used with the hardener arms 3340 and can provide additional comfort for the patient. The sleeve can not add additional connection points to connect the positioning and stabilising structure 3300 on the mask 3050-2. In the illustrated example, the hardener arms 3340 of the positioning and stabilising structure 3300 can be connected directly to the mask 3050-2.

[0364] As shown in FIG. 5P , the two point headgear 3302-2 can be connected to tabs 3320 on the sleeve in order to provide tension to hold the mask 3050-2 in a sealing position on the patient’s head.

[0365] 5.3.6.3.5 Element modularity

[0366] FIG. 5O It is shown how different elements can be combined to form the four different patient interfaces described above. As shown, different components can be reused for different types of patient interfaces. This can allow for easier manufacturing and assembly as a large number of the same components can be produced and used in multiple types. The only component that can not be used in multiple types can be the sleeve. However, the sleeve can be easier to manufacture. FIG. 5N It is shown how a portion of the air circuit 4170 can be connected with the patient interface, while FIG. 5O it is shown how the vent housing 3404 of the air circuit shown in FIGS. 4A-4C may be interchangeably replaced depending on the type of patient interface.

[0367] 5.4 RPT device

[0368] As shown in FIG. 4A , an RPT device 4000 according to one aspect of the present technology comprises mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300, for example any of the whole or part of the methods described herein. The RPT device 4000 can be configured to generate a flow of air for delivery to the airways of a patient, for example for treating one or more respiratory conditions described elsewhere in this document.

[0369] 5.4.1 Air filter

[0370] An RPT device according to one form of the present technology can comprise one air filter 4110, or a plurality of air filters 4110.

[0371] In one form as illustrated, an inlet air filter 4112 is located at the start of the pneumatic path upstream of the pressure generator 4140. FIG. 4A

[0372] In one form as illustrated, an outlet air filter 4114, for example an anti-bacterial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800. FIG. 4A

[0373] 5.4.2 Silencer

[0374] An RPT device in accordance with one form of the present technology can include a silencer 4120, or a plurality of silencers 4120.

[0375] In one form of the present technology (see for example FIG. 4A ), an inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0376] In one form of the present technology, an outlet silencer 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800.

[0377] 5.4.3 Pressure Generator

[0378] In one form of the present technology, the pressure generator 4140 for generating a flow of positive pressure air, or a supply of air, is a controllable blower 4142.

[0379] The pressure generator 4140 can be under the control of the therapy device controller 4240.

[0380] In other forms, the pressure generator 4140 can be a piston driven pump, a pressure regulator connected to a high pressure source (for example, a reservoir of compressed air), or a bellows.

[0381] 5.4.4 Transducer

[0382] The transducer can be internal to the RPT device, or external to the RPT device. An external transducer can be located on or form part of the air circuit (for example, the patient interface), for example. An external transducer can be in the form of a non-contact sensor, for example a Doppler radar motion sensor that transmits or transduces data to the RPT device.

[0383] In one form of the present technology (see for example FIG. 4A ​​), one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 can be constructed and arranged to generate a signal representative of a characteristic of the flow of air at that point in the pneumatic path, for example the flow, pressure or temperature.

[0384] In one form of the present technology, one or more transducers 4270 can be located in the vicinity of the patient interface 3000 or 3800.

[0385] In one form, signals from the transducers 4270 can be filtered, such as by low pass, high pass or band pass filtering.

[0386] 5.4.5 RPT Sensor

[0387] 5.4.5.1 Flow Rate Sensor

[0388] Flow sensors 4274 according to the present technology can be based on differential pressure transducers, for example the SDP600 series differential pressure transducers from SENSIRION.

[0389] In one form, signals generated by the flow sensor 4274 and representative of flow rate are received by the central controller 4230.

[0390] 5.4.5.2 Pressure Sensor

[0391] Pressure sensors 4272 according to the present technology are positioned in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. Another suitable pressure sensor is a transducer from the NPA series from GENERAL ELECTRIC.

[0392] In one form, signals generated by the pressure sensor 4272 and representative of pressure are received by the central controller 4230.

[0393] 5.4.6 Motor Speed Transducer

[0394] In one form of the present technology, a motor speed transducer 4276 is used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed transducer 4276 can 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.

[0395] 5.4.7 Anti-overflow back valve

[0396] As FIG. 4BAs shown, in one form of the technology, an anti-overflow return valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-overflow return valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0397] 5.4.8 RPT DEVICE ELECTRICAL COMPONENTS

[0398] 5.4.8.1 Power Supply

[0399] The power supply 4210 can be located internal or external to the external housing 4010 of the RPT device 4000.

[0400] In one form of the technology, the power supply 4210 provides power to the RPT device 4000 only. In another form of the technology, the power supply 4210 provides power to both the RPT device 4000 and the humidifier 5000.

[0401] 5.4.8.2 Input Device

[0402] In one form of the technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches or dials to allow a human to interact with the device. The buttons, switches or dials can be physical devices or software devices accessible through a touch screen. The buttons, switches or dials can be physically connected to the external housing 4010 in one form or can wirelessly communicate with a receiver electrically connected to the central controller 4230 in another form.

[0403] In one form, the input devices 4220 can be constructed and arranged to allow a human to select values and / or menu options.

[0404] 5.4.8.3 Central Controller

[0405] In one form of the technology, the central controller 4230 is one or more processors adapted to control the RPT device 4000. The central controller 4230 is shown in FIG. 4B Figure 5.4.8.3.

[0406] Suitable processors can include x86 INTEL processors, ARM Holdings based processors, such as the processors of the STM32 series microcontrollers from ST MICROELECTRONICS. In certain alternative forms of the technology, 32-bit RISC CPUs such as the STR9 series microcontrollers from ST MICROELECTRONICS or 16-bit RISC CPUs such as the processors of the MSP430 series microcontrollers manufactured by TEXAS INSTRUMENTS can also be suitable.

[0407] ​In one form of the technology, the central controller 4230 is a dedicated electronic circuit.

[0408] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 comprises discrete electronic components.

[0409] The central controller 4230 can be configured to receive input signals from one or more of the transducers 4270, the one or more input devices 4220, and / or the humidifier 5000.

[0410] The central controller 4230 can be configured to provide output signals to one or more of the output devices 4290, the pressure generator 4140, the therapy device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0411] In some forms of the technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 that can be implemented with processor control instructions represented as computer programs stored in a non-transitory computer readable storage medium such as the memory 4260. In some forms of the technology, the central controller 4230 can be integrated with the RPT device 4000. However, in some forms of the technology, some methods can be performed by a remotely located device. For example, a remotely located device can determine control settings for a ventilator or detect a breathing related event by analysing stored data (e.g. from any of the sensors described herein).

[0412] 5.4.8.4 Clock

[0413] The RPT device 4000 can include a clock 4232 connected to the central controller 4230.

[0414] 5.4.8.5 Therapy device controller

[0415] In one form of the technology, the therapy device controller 4240 is a therapy control module 4330 that forms part of the algorithm 4300 executed by the central controller 4230.

[0416] In one form of the technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, an MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0417] 5.4.8.6 Protection circuitry

[0418] One or more protection circuits 4250 according to the technology can include electrical protection circuitry, temperature and / or pressure safety circuitry.

[0419] 5.4.8.7 Memory

[0420] According to one form of the present technology, the RPT device 4000 includes a memory 4260, for example a non-volatile memory. In some forms, the memory 4260 can include a battery backed-up static RAM. In some forms, the memory 4260 can include a volatile RAM.

[0421] The memory 4260 can be located on the PCBA 4202. The memory 4260 can be in the form of an EEPROM or a NAND flash memory.

[0422] Additionally or alternatively, the RPT device 4000 includes a memory 4260 in removable form, for example a memory card manufactured according to the Secure Digital (SD) standard.

[0423] In one form of the present technology, the memory 4260 acts as a non-transitory computer readable storage medium having stored thereon computer program instructions which are representative of one or more methods described herein, such as one or more algorithms 4300.

[0424] 5.4.8.8 Data communication system

[0425] In one form of the present technology, a data communication interface 4280 is provided, which is connected to the central controller 4230 (see, for example, FIGS. 4A-4C ). The data communication interface 4280 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.

[0426] In one form, the data communication interface 4280 is part of the central controller 4230. In another form, the data communication interface 4280 is separate to the central controller 4230, and can comprise an integrated circuit or a processor.

[0427] In one form, the remote external communication network 4282 is the internet. The data communication interface 4280 can connect to the internet using a wired communication (for example via Ethernet or optical fibre) or a wireless protocol (for example CDMA, GSM, LTE).

[0428] In one form, the local external communication network 4284 utilises one or more communication standards, for example Bluetooth or the consumer infrared protocol.

[0429] In one form, the remote external device 4286 is one or more computers, e.g., a cluster of networked computers. In one form, the remote external device 4286 can be a virtual computer, rather than a physical computer. In either case, such a remote external device 4286 can be accessible to a person properly authorized, e.g., a clinician.

[0430] The local external device 4288 can be a personal computer, a mobile phone, a tablet, or a remote control device.

[0431] 5.4.8.9 Output device including optional display, alarm

[0432] The output device 4290 according to the present technology can take the form of one or more of a visual, audio, and tactile unit. The visual display can be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0433] 5.4.8.9.1 Display driver

[0434] The display driver 4292 receives as input characters, symbols, or images to be displayed on the display 4294 and converts them into commands that cause the display 4294 to display the characters, symbols, or images.

[0435] 5.4.8.9.2 Display

[0436] The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 can be an eight-segment display, in which case the display driver 4292 converts each character or symbol (e.g., the figure “0”) into 8 logical signals that indicate whether the 8 corresponding segments are to be activated to display the particular character or symbol.

[0437] Reference is now made to FIG. 6 In some forms of the present technology, the central controller 4230 can be configured to implement one or more algorithms 4300 represented as computer programs stored in a non-transitory computer readable storage medium, e.g., the memory 4260. The algorithms 4300 are generally grouped into sets called modules.

[0438] In other forms of the present technology, some or all of the algorithm 4300 can 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 required by the portion of the algorithm 4300 to be executed at the external device can 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 algorithm 4300 to be executed at the external device can be represented as a computer program, for example having processor control instructions to be executed by one or more processors, stored in a non-transitory computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to perform the portion of the algorithm 4300.

[0439] In such forms, therapy parameters generated by the external device via the therapy engine module 4320 (if forming part of the portion of the algorithm 4300 executed by the external device) can be communicated to the central controller 4230 to be passed to the therapy control module 4330.

[0440] 5.4.8.10 Pre-processing module

[0441] A pre-processing module 4310 according to one form of the present technology receives signals from the transducer 4270 (e.g. flow sensor 4274 or pressure sensor 4272) as input, and performs one or more processing steps to calculate one or more output values to be used as input to another module (e.g. therapy engine module 4320).

[0442] In one form of the present technology, the output values include the interface pressure Pm, the ventilation flow Qv, the respiratory flow Qr, and the leak flow Ql.

[0443] In various forms of the present technology, the pre-processing module 4310 includes one or more of the following algorithms: an interface pressure estimation algorithm 4312, a ventilation flow estimation algorithm 4314, a leak flow estimation algorithm 4316, and a respiratory flow estimation algorithm 4318.

[0444] 5.4.8.10.1 Interface pressure estimation

[0445] In one form of the present technology, an interface pressure estimation algorithm 4312 receives as input a signal from the pressure sensor 4272 indicative of the pressure in the pneumatic path adjacent the outlet of the pneumatic block (device pressure Pd) and a signal from the flow sensor 4274 representative of the flow of air leaving the RPT device 4000 (device flow Qd). In the absence of any supplemental gas 4180, the device flow Qd can be used as the total flow Qt. The interface pressure estimation algorithm 4312 estimates the pressure drop ΔΡ across the air circuit 4170. The dependence of the pressure drop ΔΡ on the total flow Qt can be modelled by a pressure drop characteristic ΔΡ(Ο) for the particular air circuit 4170. The interface pressure estimation algorithm 4312 then provides as output an estimated pressure Pm in the patient interface 3000 or 3800. The pressure Pm in the patient interface 3000 or 3800 can be estimated as the device pressure Pd less the air circuit pressure drop ΔΡ.

[0446] 5.4.8.10.2 Ventilation flow estimation

[0447] In one form of the present technology, a ventilation flow estimation algorithm 4314 receives as input the estimated pressure Pm in the patient interface 3000 or 3800 from the interface pressure estimation algorithm 4312 and estimates the ventilation flow Qv of air from the vent 3400 in the patient interface 3000 or 3800. For a particular vent 3400 in use, the dependence of the vent flow Qv on the interface pressure Pm can be modelled by a vent characteristic Qv(Pm).

[0448] 5.4.8.10.3 Leak flow estimation

[0449] In one form of the present technology, a leak flow estimation algorithm 4316 receives as input the total flow Qt and the ventilation flow Qv and provides as output an estimate of the leak flow Ql. In one form, the leak flow estimation algorithm estimates the leak flow Ql by calculating the average of the difference between the total flow Qt and the ventilation flow Qv over a sufficiently long period of time, for example about 10 seconds.

[0450] In one form, the leak flow estimation algorithm 4316 receives as input the total flow Qt, the ventilation flow Qv and the estimated pressure Pm in the patient interface 3000 or 3800 and provides as output the leak flow Ql by calculating a leak conductance and determining the leak flow Ql as a function of the leak conductance and the pressure Pm. The leak conductance is calculated as the quotient of a low pass filtered non-ventilation flow and a low pass filtered pressure square root Pm, the low pass filtered non-ventilation flow being equal to the difference between the total flow Qt and the ventilation flow Qv, wherein the low pass filter time constant has a value sufficiently long to include several breathing cycles, for example about 10 seconds. The leak flow Ql can be estimated as the product of the leak conductance and the function of the pressure Pm.

[0451] 5.4.8.10.4 Breathing flow rate estimation

[0452] In one form of the present technology, a breathing flow rate estimation algorithm 4318 receives as inputs total flow rate Qt, ventilation flow rate Qv, and leak flow rate Ql, and estimates a breathing flow rate Qr of air to the patient by subtracting ventilation flow rate Qv and leak flow rate Ql from total flow rate Qt.

[0453] 5.4.8.11 Therapy engine module

[0454] In one form of the present technology, a therapy engine module 4320 receives as inputs one or more of pressure in the patient interface 3000 or 3800, Pm, and breathing flow rate Qr of air to the patient, and provides as an output one or more therapy parameters.

[0455] In one form of the present technology, the therapy parameter is a therapy pressure Pt.

[0456] In one form of the present technology, the therapy parameter is one or more of a pressure variation amplitude, a base pressure, and a target ventilation.

[0457] In various forms, the therapy engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow limitation determination 4324, apnea / hypopnea determination 4325, snoring determination 4326, airway openness determination 4327, target ventilation determination 4328, and therapy parameter determination 4329.

[0458] 5.4.8.11.1 Phase determination

[0459] In one form of the present technology, the RPT device 4000 does not determine a phase.

[0460] In one form of the present technology, a phase determination algorithm 4321 receives as an input a signal indicative of breathing flow rate Qr, and provides as an output a phase Φ of a current respiratory cycle of the patient 1000.

[0461] 5.4.8.11.2 Waveform determination

[0462] In one form of the present technology, the therapy parameter determination algorithm 4329 provides a therapy pressure that is approximately constant throughout a respiratory cycle of the patient.

[0463] In other forms of the present technology, the therapy control module 4330 controls the pressure generator 4140 to provide a therapy pressure Pt that varies as a function of phase Φ of a respiratory cycle of the patient according to a waveform template Π(Φ).

[0464] In one form of the present technology, a waveform determination algorithm 4322 provides a waveform template Π(Φ) of values in the range [0, 1] over the domain of phase values Φ provided by the phase determination algorithm 4321 for use by the treatment parameter determination algorithm 4329.

[0465] 5.4.8.11.3 Determination of ventilation

[0466] In one form of the present technology, a ventilation determination algorithm 4323 receives an input of respiratory flow rate Qr and determines a measure indicative of current patient ventilation Vent.

[0467] 5.4.8.11.4 Determination of inspiratory flow limitation

[0468] In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 for determining a degree of inspiratory flow limitation.

[0469] 5.4.8.11.5 Determination of apnoea and hypopnoea

[0470] In one form of the present technology, the central controller 4230 executes an apnoea / hypopnoea determination algorithm 4325 for determining the presence of apnoea and / or hypopnoea.

[0471] 5.4.8.11.6 Determination of snoring

[0472] In one form of the present technology, the central controller 4230 executes one or more snoring determination algorithms 4326 for determining a degree of snoring.

[0473] 5.4.8.11.7 Determination of airway patency

[0474] In one form of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 for determining a degree of airway patency.

[0475] 5.4.8.11.8 Determination of target ventilation

[0476] In one form of the present technology, the central controller 4230 takes as input a measure of current ventilation Vent and executes one or more target ventilation determination algorithms 4328 for determining a target value Vtgt of the ventilation measure.

[0477] 5.4.8.11.9 Determination of treatment parameters

[0478] In some forms of the present technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 for determining one or more treatment parameters using values returned by one or more other algorithms in the treatment engine module 4320.

[0479] 5.4.8.12 Therapy control module

[0480] The therapy control module 4330 according to one aspect of the present technology receives as input therapy parameters from the therapy parameter determination algorithm 4329 of the therapy engine module 4320, and controls the pressure generator 4140 to deliver a flow of air in accordance with the therapy parameters.

[0481] In one form of the present technology, the therapy parameters are a therapy pressure Pt, and the therapy control module 4330 controls the pressure generator 4140 to deliver a flow of air at the interface pressure Pmat the patient interface 3000 or 3800 equal to the therapy pressure Pt.

[0482] 5.4.8.13 Detection of fault conditions

[0483] In one form of the present technology, the central controller 4230 executes one or more methods 4340 for detecting fault conditions. Fault conditions detected by the one or more methods 4340 can include at least one of:

[0484] • Power failure (no power or insufficient power)

[0485] • Converter fault detection

[0486] • Failure to detect presence of component

[0487] • Operating parameters outside recommended ranges (e.g. pressure, flow rate, temperature, PaO2)

[0488] • Test alarms fail to produce a detectable alarm signal.

[0489] On detection of a fault condition, the corresponding algorithm signals the presence of the fault by one or more of:

[0490] • Initiating an audible, visual and / or dynamic (e.g. vibration) alarm

[0491] • Sending a message to an external device

[0492] • Event logging

[0493] 5.5 Patient interface detection

[0494] FIG. 6A schematic view of a respiratory therapy system 8000 is shown. The respiratory therapy system 8000 can be configured to wirelessly detect information about the patient interface 3000 or an accessory being used by the patient during a therapy session. In some aspects, the technology described further below in conjunction can create a patient interface (or accessory) detection system where the patient does not need to manually scan or input (e.g., via an external device like a smart phone, computer, or tablet, or via a mechanism within the respiratory therapy system) the type of patient interface being used. In other aspects, the incorporation of a wireless patient interface detection system can allow the respiratory therapy system 8000 to confirm the accuracy of patient input regarding the type of patient interface (or accessory) being used, or can track usage or other characteristics of the patient interface (or accessory) being used, as described further below.

[0495] The respiratory therapy system 8000 includes a patient interface 3000 and a respiratory pressure therapy (RPT) device 4000 fluidically coupled by an air circuit 4170, which can be a conduit or tube, as described above. The RPT device 4000 is configured to supply a flow of gas, which can be air supplemented with oxygen, for example, to the patient interface 3000 through the air circuit 4170, as described above. The RPT device 4000 can include any of the elements described above, such as a humidifier, an oxygen source, and / or a data management system.

[0496] The RPT device 4000 can be used alone or as part of the system 8000 to deliver one or more of a variety of therapies described above, for example, by operating the device to generate a flow of gas that is delivered to an interface to a user’s airways, such as the patient interface 3000. The flow of gas can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Thus, the RPT device 4000 can also be a flow therapy device. The RPT device 4000 may, for example, include a CPAP device and / or a ventilator.

[0497] The respiratory therapy system 8000 can also include a radio frequency identification (RFID) system 9000. The RFID system 9000 may, for example, be configured to detect one or more characteristics of respiratory therapy delivered from the RPT device 4000 to the patient interface 3000, an identification of the patient interface 3000, and / or an identification of an accessory device (not shown) coupled directly or indirectly to the respiratory therapy system 8000. Exemplary accessory devices can 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 moisture exchanger or a waterless humidifier), a conduit, and / or an adapter accessory.

[0498] RFID is a form of wireless communication that combines the use of electromagnetic or electrostatic coupling in the radio frequency portion of the electromagnetic spectrum to, for example, uniquely identify and / or track objects. The RFID system 9000 can operate according to the principles of inductive coupling.

[0499] 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, for example, reflected signals from the tag 9200. The antenna 9100 can be a linear antenna and thus can emit linearly polarized signals, or the antenna 9100 can be a circular antenna and thus can emit circularly polarized signals. In some embodiments, the RFID system 9000 can include both linear and circular antennas.

[0500] The antenna 9100 can be disposed within a proximal portion of the air circuit 4170 (e.g., proximate to the patient interface 3000). For example, the antenna 9100 can be disposed within a portion of the air circuit 4170, such as within a cover 4172 on a proximal end portion 4170A of the air circuit 4170. In alternative embodiments, the antenna 9100 can be disposed in a lumen of the air circuit 4170. In further alternative configurations, the antenna 9100 can be fixedly or removably coupled to an exterior of the air circuit 4170, such as on an outer surface of the air circuit 4170. In further alternative embodiments, the antenna 9100 can be disposed between components of the respiratory system 8000, such as between the patient interface 3000 and the air circuit 4170 and / or between the RPT device 4000 and the air circuit 4170. Further, the antenna 9100 can be placed external to the respiratory system 8000. For example, the antenna 9100 can be external to the RPT device 4000, the air circuit 4170, and the patient interface 3000.

[0501] The tag 9200 is configured to emit radio waves to transmit information. The tag 9200 can contain a microchip or circuit board that stores and processes information, such as a unique identifier of the tag 9200 and the antenna 9100 to enable the tag 9200 to receive and / or emit radio signals. The tag 9200 can be an active tag or a passive tag. If a passive tag is used, it can rely on the power of the antenna to transmit data and thus can have a shorter transmission range. For example, the tag 9200 can receive all the energy it needs from the magnetic field in which the tag 9200 operates.

[0502] The tag 9200 can be read-only, read / write, or write-once, read-many. The tag 9200 can be configured to include identification data of the patient interface 3000 and / or the patient. In some aspects, the tag 9200 can include information related to a date or time stamp of use. The tag 9200 can additionally or alternatively include information related to a type of patient interface 3000 used, a characteristic of the patient interface 3000 (e.g., one or more of a cushion material, a cushion size, a conduit size, a patient interface size, a length of use of the patient interface, a date of manufacture of the patient interface, a set of respiratory therapy conditions for which 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 can be configured to include patient information, such as a type or setting of therapy that the patient is intended to receive, or other information. The tag 9200 can also be used to detect connection and / or disconnection of the air circuit 4170 and / or an accessory device (not shown).

[0503] As will be discussed in further detail below, in some embodiments, the tag 9200 can include an adhesive, for example, to help apply the tag 9200 to the patient interface 3000 and / or to hold the tag 9200 in place on the patient interface 3000 after application. Alternatively, the tag 9200 can be overmolded within a portion of the patient interface 3000. For example, the tag 9200 can be overmolded into a soft plastic material, such as a silicone cushion, or overmolded into a hard plastic material, such as a plastic frame of the patient interface 3000. Alternatively, the tag 9200 can include conductive silicone and / or conductive wires or ink (e.g., silver ink) printed on a soft and / or hard plastic material that makes up the patient interface 3000. The tag 9200 can include, for example, an overmolded inlay tag, a conductive fabric, or can be coupled to the patient interface 3000 in any suitable method used in the art. In some embodiments, one or more surfaces of the tag 9200 can be treated, for example, to improve adhesion to the patient interface 3000, a headgear tube 3350 of a headgear cuff, and / or other components of the respiratory therapy system 8000. Additionally or alternatively, an adhesive or primer can be applied to a surface of the tag 9200. In some embodiments, one or more surfaces of the tag 9200 can include one or more features configured to increase a surface area of the tag 9200. For example, a surface of the tag 9200 can include one or more holes, protrusions, indentations, or combinations thereof to facilitate inclusion in one or more components of the respiratory therapy system 8000.

[0504] Tag 9200 can be an RFID tag, and in some cases can be a near field communication (NFC) tag. Tag 9200 can be configured to generate an electromagnetic field having a frequency of about 10 Mhz to about 12 GHz (e.g., about 13.56 megahertz (MHz)), and antenna 9100 can be configured to read data transmitted from tag 9200 at about 10 Mhz to about 12 GHz (e.g., about 13.56 MHz). In other aspects, RFID system 9000 can alternatively be configured to generate an electromagnetic field having a frequency between about 30 kilohertz (kHz) and about 3 gigahertz (GHz). In some examples, RFID system 9000 can be configured to operate in a low frequency range, or between about 30 kHz and 300 kHz. Accordingly, RFID system 9000 can be configured to have a read range of up to about 10 centimeters (about 3.94 inches), although the exact distance can vary depending on, for example, the angle of the individual components in the system relative to one another. Alternatively, RFID system 9000 can be configured to operate in a high frequency range, or between about 3 Mhz and 30 MHz. In such a configuration, RFID system 9000 can be configured to have a read range of between about 10 centimeters to about one meter (about 3.94 inches to about 39.37 inches).

[0505] Further, RFID system 9000 can be configured to operate in an ultra-high frequency range, or between about 300 Mhz and 3 GHz. In such a configuration, RFID system 9000 can be configured to have a read range of between about one meter to about 12 meters. For example, tag 9200 can be an ultra-high frequency (UHF) tag, a Bluetooth tag, or an ultra-wideband (UWB) tag. Tag 9200 and antenna 9100 can be tuned to operate on the same frequency. UWB tag 9200 can operate in a frequency range of about 3.1 Ghz to about 10.6 Ghz, Bluetooth tag 9200 can operate at a frequency of about 2.5 GHz, and UHF tag 9200 can operate in a frequency of about 300 Mhz to about 3AHz.

[0506] In some examples, a shorter read range of RFID system 9000 can be desirable. For example, if a patient is in the vicinity of multiple devices or objects containing RFID components, RFID system 9000 can inadvertently read tags or antennas on the peripheral devices. Accordingly, if RFID system 9000 is configured to operate in a low frequency range, for example, 13.56 MHz, the likelihood of RFID system 9000 inadvertently reading peripheral devices is reduced.

[0507] The RFID system 9000 can include a single tag 9200 fixedly or removably coupled to the patient interface 3000 or an accessory device (not shown). Optionally, the RFID system 9000 can include two or more tags 9200 fixedly coupled to the patient interface 3000 or an accessory device (not shown). The RFID tags 9200 described herein can be off-the-shelf components or can be customised according to the size and / or shape of the patient interface 3000 and / or according to the read range of the tags 9200. Although the tags 9200 are described herein as being associated with the patient interface 3000, the tags 9200 can optionally or additionally be associated with the air circuit 4170 or another accessory of the respiratory therapy system 8000, for example. Insofar as the tags 9200 are associated with the air circuit 4170 or another accessory, the tags 9200 can include information about the accessory or air circuit with which they are associated. Although the tags 9200 are shown in FIG. 6 FIG. 1 as being coupled to the patient interface 3000, the placement of the tags 9200 should not be so limited. For example, the tags 9200 can be on or in any part of the respiratory therapy system 8000. For example, the tags 9200 can be on / in the air circuit 4170, the RPT device 4000 and / or an accessory device (not shown). In some embodiments, the tags 9200 can be between two components of the respiratory therapy system 8000. For example, the tags 9200 can be between the patient interface 3000 and the air circuit 4170 and / or between the RPT device 4000 and the air circuit 4170.

[0508] 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 can be tuned to the same inductance as the tag 9200 for different types of patient interfaces 3000, such that the antenna 9100 can be compatible with a variety of patient interfaces 3000. The transceiver 9300 can be operably connected to the antenna 9100 physically (e.g., via a wire) and can be located on or in the air circuit 4170 or the adaptor 9400. In one configuration, the transceiver 9300 can be located on or in the RPT device 4000. In one configuration, the transceiver 9300 can be external to the respiratory therapy system 8000. For example, the transceiver 9300 can be a scanner, a smartphone, a tablet or any other device configured to receive an RFID signal transmitted from an RFID tag or antenna. Thus, the antenna 9100 is configured to transfer data received from the tag 9200 to the transceiver 9300. The antenna 9100 can comprise a flexible circuit board. The transceiver 9300 can also be configured to save or store data transmitted from the antenna 9100.

[0509] Still referring to FIG. 7AThe transceiver 9300 can include a controller on a flexible circuit, e.g., connected within the air circuit 4170. The transceiver 9300 can relay information from the antenna 9100 to a controller configured to control the RPT device 4000. The controller can be separate from the RPT device 4000 or can be incorporated as part of the RPT device 4000. The controller can operate as described above. The transceiver 9300 can generate an electromagnetic field having a suitable frequency, e.g., 13.56 MHz, and can be configured to read the tag 9200 from the patient interface 3000 or an accessory coupled at the patient interface 3000. The accessory can include, but is not limited to, one or more of a headgear, a cushion, a heat and moisture exchanger or waterless humidifier, an air filter, an air conduit or an adapter of the patient interface, as described above.

[0510] In some configurations, the transceiver 9300 can be configured to transmit data to the RPT device 4000, either physically (e.g., via a wire) or wirelessly. The RPT device 4000 can also be configured to save or store data transmitted from the transceiver 9300, interpret the transmitted data, and / or transmit an alert or signal to a user or care provider, as described above. In some embodiments, the RPT device 4000 can also be configured to automatically change one or more characteristics of the respiratory pressure treatment, e.g., based on raw and / or interpreted data received from the transceiver 9300. Additionally or alternatively, the RPT device 4000 can be configured to suggest one or more treatment settings, e.g., to facilitate patient care and / or patient comfort based on interpreted data from the transceiver 9300, as will be discussed further below.

[0511] To integrate the antenna 9100 and / or the 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 the antenna 9100 and / or the tag 9200 can be overmolded with a silicone (e.g., liquid silicone rubber). However, it can be difficult to bond liquid silicone rubber to a flexible printed circuit board because it is unlikely for a bond to occur naturally between the liquid silicone rubber and the flexible printed circuit board. This can result in the liquid silicone rubber peeling away from the flexible printed circuit board of the antenna 9100 and / or the tag 9200. Such a result can impair the ability to successfully incorporate the antenna 9100 and / or the tag 9200 into components of the respiratory therapy system 8000. One or more aspects below can be used to facilitate retaining silicone, e.g., liquid silicone rubber or other flexible material, on a printed circuit board.

[0512] FIG. 7B A perspective view of an example circuit board 9210 (hereinafter "board" 9210) is shown. FIG. 7A A perspective view of an example circuit board 9210 (hereinafter "board" 9210) is shown. FIG. 6 A side cross-sectional view of the board 9210 is shown. The tag 9200 (FIG. 6 ) can include a board 9210. For example, the board 9210 can be a microchip configured to store and process information in the tag 9200. Such information can include, for example, a unique identifier for the tag 9200 and the antenna 9100 to enable the tag 9200 to receive and / or transmit radio signals, as described above with reference to FIGS. 1-3. In some examples, the board 9210 can be a microchip incorporated as part of an antenna (e.g., the antenna 9100). While a single board 9210 is shown, the antenna 9100 and / or the tag 9200 can include additional (e.g., two or more) boards 9210. In some examples, the board 9210 can be coupled or bonded to a surface of one or more components of the respiratory therapy system 8000. In other examples, the board 9210 (of the tag 9200 and / or the antenna 9100) can be overmolded on one or more components of the respiratory therapy system 8000. For example, the board 9210 can be embedded in or formed with one or more components of the respiratory system 8000, such as a patient interface, a headgear tube, or an air circuit. FIG. 6 FIG. 6 The board 9210 can be a flexible printed circuit (FPC) including at least three layers: a first layer 9212, a second layer 9214, and a third layer 9216. The second layer 9214 can be disposed between the first layer 9212 and the third layer 9216. In some examples, the board 9210 can include one or more openings 9218.

[0513] The one or more openings 9218 can extend through the entire first layer 9212, for example, to expose a portion of the second layer 9214. The openings 9218 can be configured such that a user can couple or solder an electrical element (e.g., a wire, a cable, etc.) to the second layer 9214 of the board 9210. While not shown, the third layer 9216 can include one or more openings 9218. For example, both the first layer 9212 and the third layer 9216 can have openings 9218 that extend through each respective layer and expose a portion of the second layer 9214.

[0514] The one or more openings 9218 can extend through the entire first layer 9212, for example, to expose a portion of the second layer 9214. The openings 9218 can be configured such that a user can couple or solder an electrical element (e.g., a wire, a cable, etc.) to the second layer 9214 of the board 9210. While not shown, the third layer 9216 can include one or more openings 9218. For example, both the first layer 9212 and the third layer 9216 can have openings 9218 that extend through each respective layer and expose a portion of the second layer 9214.

[0515] ​In some examples, only one of the first layer 9212 and the third layer 9216 can have openings 9218 extending through each respective layer. Although three rectangular openings 9218 are shown on discrete portions of the board 9210, the openings 9218 can be located on any portion of the board 9210 and can have any suitable shape and / or size. For example, the openings 9218 can be circular openings randomly positioned on the first layer 9212 and / or the third layer 9216. In some examples, the openings 9218 can be circular on the first layer 9212 and rectangular on the third layer 9216. Other combinations or configurations of openings 9218 on the first layer 9212 and / or the third layer 9216 are contemplated.

[0516] Each of the first layer 9212 and the third layer 9216 can cover a flexible printed circuit board and can act as a solder resist for the flexible printed circuit board. The first layer 9212 and the third layer 9216 can be configured to encapsulate and protect the circuitry contained on or within the second layer 9214. The second layer 9214 can be formed of a conductive material, such as copper, to allow for electrical connections between components. The first layer 9212 and the third layer 9216 can be glued or otherwise attached to opposite surfaces of the second layer 9214 to protect the conductive structure, such as the copper structure.

[0517] In some examples, the first layer 9212 and / or the third layer 9216 can include polyimide or another amorphous plastic that exhibits temperature stability, flexibility, and high strength. For example, each of the first layer 9212 and the third layer 9216 can be solder resistant. In some examples, a surface of each of the first layer 9212 and the third layer 9216 that contacts or abuts a respective surface of the second layer 9214 can include an epoxy and / or an adhesive. In this way, the first layer 9212 can be bonded to a first surface of the second layer 9214, and the third layer 9216 can be bonded to a second surface of the second layer 9214. For example, the first layer 9212, the second layer 9214, and the third layer 9216 can be laminated under heat and pressure to form the board 9210. Although three layers (9212, 9214, 9216) are shown, the board 9210 can include additional layers.

[0518] In some examples, the board 9210 and / or the antenna 9100 of the label 9200 can be bonded or coupled to one or more components of a respiratory therapy system, such as a patient interface, a headgear tube, and / or an air circuit. For example, as described above with reference to FIG. 1, the board 9210 and / or the antenna 9100 can be bonded or coupled to a patient interface 1000, a headgear tube 1100, and / or an air circuit 1200. FIG. 7AAs shown and described, the plate 9210 can be coupled to the patient interface 3000. Additionally or alternatively, the plate 9210 can be connected to the headgear tube 3350 of the headgear of the respiratory therapy system 8000 and / or other components of the respiratory therapy system 8000. In some aspects, the plate 9210 of the label 9200 and / or the antenna 9100 can be overmolded onto a material such as silicone (e.g., liquid silicone rubber) in order to bond the plate 9210 into one or more components.

[0519] In some examples, an outer surface of the first layer 9212 (i.e., a surface of the first layer 9212 opposite from a surface facing the second layer 9214) and / or an outer surface of the third layer 9216 (i.e., a surface of the third layer 9216 opposite from a surface facing the second layer 9214) can be bonded or coupled to one or more components of the respiratory therapy system 8000. The one or more components of the respiratory therapy system 8000 can include various materials. For example, the components of the respiratory therapy system 8000 can include various hard and soft plastics and / or silicones. As described above, bonding the first layer 9212 and / or the third layer 9216 to components of the respiratory therapy system 8000 can present challenges. In particular, bonding of materials commonly used for cover layers (e.g., the first layer 9212 and the third layer 9216) to polyimide can be difficult. For example, due to the high thermal stability, low surface energy, non-polar nature, and / or chemical resistance of polyimide, bonding the circuit board 9210 to one or more components of the respiratory therapy system can present difficulties.

[0520] To overcome this challenge, the material of the first layer 9212 and / or the third layer 9216 can be selected to facilitate bonding to other materials. For example, the first layer 9212 and / or the third layer 9216 can include a thermoplastic polyurethane (TPU or TPE-U) and / or a thermoplastic polyurethane blend. For example, TPU can be desirable due to the chemical structure of TPU, the moderate to high surface energy, the compatibility with adhesives, and other properties.

[0521] The first layer 9212 and / or the third layer 9216 can optionally include a polyethylene terephthalate (PET) and / or a silicone film. For example, PET can be desirable due to its high surface energy, surface texture, and compatibility with adhesives, among other aspects. For similar reasons, a silicone film can be desirable.

[0522] TPU, PET, and / or silicone can be advantageous for a number of reasons. For example, TPU, PET, and / or silicone materials can be advantageous because each material has the ability to stretch and / or flex. For example, due to the stretchability and / or flexibility of TPU, PET, and / or silicone, a board 9210 including such a material can allow the board 9210 to flex and / or otherwise form complex shapes. TPU, PET, and / or silicone can also be advantageous because each material has a high heat resistance. For example, circuit traces can be directly sintered onto a circuit board (e.g., board 9210) including TPU, PET, and / or silicone. TPU, PET, and / or silicone can also be advantageous because of the biocompatibility of each material and / or the chemical or moisture resistance of each material. For example, a board including TPU, PET, and / or silicone can resist corrosion due to exposure to dilute acids, oils, solvents, ozone, tar, and / or other chemicals. Other materials having one or more similar properties can also be suitable for use as the first layer 9212 and / or the third layer 9216.

[0523] In some examples, the first layer 9212 can include a first material, while the third layer 9216 can include a second material. For example, the first layer 9212 can include TPU, while the third layer 9216 can include PET.

[0524] In some aspects, the first layer 9212 and / or the third layer 9216 can include an outer surface having an improved bond strength, an improved adhesion capability, a higher surface roughness, and / or an improved coupling capability relative to an inner surface of the first layer 9212 and / or the third layer 9216, wherein the inner surface of the first layer 9212 and / or the third layer 9216 is secured to the second layer 9214.

[0525] Still referring to FIG. 8A and 7B In some examples, a surface of the first layer 9212 and / or the third layer 9216 can be treated, for example, to improve adhesion capability and bonding with other materials. For example, an outer surface of one or both of the first layer 9212 and the third layer 9216 can be subjected to a plasma treatment and / or a corona treatment. Plasma treatment and / or corona treatment can be used for the first layer 9212 and / or the third layer 9216 formed of any of the materials described above, including polyimide or other amorphous plastic, TPU, PET, and / or silicone film.

[0526] Plasma treatment is a surface treatment technique used to alter the properties of a material's surface. In particular, plasma treatment is a low-pressure gas treatment that removes organic contaminants, for example, to improve the acceptability of a secondary manufacturing process. For example, a material's surface can be micro-etched to improve adhesion strength without changing the material's transparency, haze, transmittance, or other visual properties. Depending on the desired surface modification, various gases such as oxygen, nitrogen, argon, or gas mixtures can be used for plasma treatment. Corona treatment is a surface treatment technique used to increase surface energy. In particular, corona treatment is accomplished by applying a voltage when a material is in a corona treatment machine. When the voltage is applied, surrounding oxygen molecules are broken down into atoms. The resulting atoms can bond with the molecular ends present in the material being treated, thereby chemically activating the surface. When the atoms bond with the material's molecules, the surface tension can increase, causing the surface to become more easily adhered.

[0527] The entire outer surface of the first layer 9212 and / or the third layer 9216 can be treated using one or more of these surface treatment techniques. Alternatively, one or more discrete portions of the outer surface of the first layer 9212 and / or the third layer 9216 can be treated. For example, the outer periphery of the first layer 9212 and / or the third layer 9216 can be treated, the corners of the first layer 9212 and / or the third layer 9216 can be treated, and / or the central portion of the first layer 9212 and / or the third layer 9216 can be treated. In some examples, the first layer 9212 can be subjected to a first treatment, while the third layer 9216 can be subjected to a different second treatment, such that the surface properties on each side of the plate 9210 are different.

[0528] In other examples, an adhesive and / or a primer material can be applied to the outer surface of the first layer 9212 and / or the third layer 9216. In some examples, an adhesive and / or primer can be applied to the surface of a component of the respiratory therapy system 8000 to which the plate 9210 is to be secured. For example, an adhesive and / or primer can be applied to the surface of the patient interface 3000, as described above. The adhesive and / or primer can act as an intermediate conduit between the outer surface of the first layer 9212 and / or the third layer 9216 and a component of the respiratory therapy system 8000 and / or another encapsulation material. For example, the adhesive and / or primer can facilitate adhesion of the outer surface of the first layer 9212 and / or the third layer 9216 to other materials.

[0529] Various primers and / or adhesives can be used. A primer is a surface coating that changes one or more properties of the surface of a material so that an adhesive will adhere more effectively to the material. For example, a primer can change the surface energy of the material. The primer can include a plastic adhesion promoter, a vinyl chloride copolymer primer, an acrylic-based primer, a polyurethane primer, an epoxy-based primer, or any combination thereof. The primer can be used in conjunction with an adhesive. For example, a primer can be applied to a surface prior to use of an adhesive. The adhesive can include an epoxy, a polyurethane, an acrylic, a cyanoacrylate, a polyvinyl acetate, an anaerobic adhesive, or any combination thereof.

[0530] The adhesive and / or primer can be applied to the entire outer surface of the first layer 9212 and / or the third layer 9216. Alternatively, the adhesive and / or primer can be applied to one or more discrete portions of the outer surface of the first layer 9212 and / or the third layer 9216. For example, the adhesive and / or primer can be applied to the outer periphery of the first layer 9212 and / or the third layer 9216, the corners of the first layer 9212 and / or the third layer 9216, and / or the central portion of the first layer 9212 and / or the third layer 9216. In some examples, a first adhesive and / or primer can be applied to the outer surface of the first layer 9212 and a second adhesive and / or primer can be applied to the outer surface of the third layer 9216.

[0531] In one example, a silicone-compatible primer can be applied to the outer surface of the first layer 9212 and / or the third layer 9216. Such a primer can include a solvent-based carrier containing reactive silane groups. When the primer is applied to the first layer 9212 and / or the third layer 9216 and exposed to moisture, the silane groups can become active, promoting adhesion between the silicone and its respective substrate.

[0532] Additionally or alternatively, the outer surface of the first layer 9212 and / or the third layer 9216 can be etched. For example, a thin layer of material of the outer layer of the first layer 9212 and / or the third layer 9216 can be removed to increase the roughness of the surface. For example, a roughened surface can promote adhesion to other materials by increasing the surface area. The etching can be performed to the entire surface of the outer surface of the first layer 9212 and / or the third layer 9216 or to one or more discrete portions of the outer surface of the first layer 9212 and / or the third layer 9216.

[0533] Each of the examples discussed herein can be used alone or in combination with one or more techniques. For example, the material of the first layer 9212 and / or the third layer 9216 can be changed and / or an adhesive can be applied to the outer surface of the first layer 9212 and / or the third layer 9216. In other examples, the first layer 9212 and / or the third layer 9216 can include polyimide and / or the outer surface of the first layer 9212 and / or the third layer 9216 can be etched. Additionally or alternatively, a primer or adhesive can be applied to the etched outer surface of the first layer 9212 and / or the third layer 9216. Various combinations are contemplated, for example, to enhance or improve adhesion between the plate 9210 and components of the respiratory therapy system 8000 (e.g., the patient interface 3000) or other materials that facilitate inclusion within the respiratory therapy system 8000.

[0534] Additionally or alternatively, one or more of the outer surfaces can include one or more features configured to, for example, increase surface adhesion with plastic or silicone materials. For example, the features can be configured to improve mechanical interlocking between the plate 9210 and materials that overmold the plate with, for example, silicone or plastic. The one or more features can create a texture on the first layer 9212 and / or the third layer 9216 to facilitate coupling of materials with the plate 9210.

[0535] FIG. 8B is a perspective view of a portion of an alternative plate 9210-A. FIG. 7A and 8C is a cross-sectional view of the plate 9210-A. The plate 9210-A can have any or all of the features of the plate 9210 described above with reference to FIG. 8B and 7B except as described below. For example, the plate 9210-A can 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 of the plate 9210-A can have any or all of the properties of the corresponding layers 9212, 9214, 9216 of the plate 9210. For example, the second layer 9214-A can be disposed between the first layer 9212-A and the third layer 9216-A. The second layer 9214-A can include a conductive material, such as copper. The first layer 9212-A and / or the third layer 9216-A can include a polyimide material or other material as described above.

[0536] One or more features 9220 can be arranged on the outer surface of the first layer 9212-A. Although not shown, the features 9220 can additionally or alternatively be arranged on the outer surface of the third layer 9216-A. The features 9220 can include recesses 9220' as shown in FIG. 8C and / or protrusions 9220" as shown in FIGS. 9A-9CThe protrusions 9220" are shown. In some examples, the first layer 9212-A and / or the third layer 9216-A can include a combination of both the recesses 9220' and the protrusions 9220". The recesses 9220' and / or the protrusions 9220" can be collectively referred to herein as features 9220.

[0537] The features 9220 can be arranged across the entire outer surface of the first layer 9212-A and / or the third layer 9216-A. For example, the features 9220 can be randomly arranged on the outer surface of the first layer 9212-A and / or the third layer 9216-A. In some examples, the features 9220 can be arranged in a pattern (e.g., a series of rows, columns, diagonals, etc.) on the first layer 9212-A and / or the third layer 9216-A. Alternatively, one or more discrete portions of the outer surface of the first layer 9212-A and / or the third layer 9216-A can include one or more features 9220. For example, the outer periphery of the first layer 9212-A and / or the third layer 9216-A can include features 9220, the corners of the first layer 9212-A and / or the third layer 9216-A, and / or the central region of the first layer 9212-A and / or the third layer 9216-A can include features 9220. In some examples, the first layer 9212-A can include a first type of feature 9220 (e.g., a recess 9220') and the third layer 9216-A can include a second type of feature 9220 (e.g., a protrusion 9220"). The features 9220 can increase the surface area of the first layer 9212-A and / or the third layer 9216-A, thereby increasing the adhesion of another material to the plate 9210-A.

[0538] FIG. 7A An optional example of features 9220" in the form of protrusions on a plate 9210-B is shown. The plate 9210-B can have FIGS. 8A-8C and 7B any and / or all features of the plate 9210 and / or FIGS. 9A-9C the plate 9210-A. FIG. 8B The plurality of features 9220"' shown in FIG. 21 can be configured such that a material can flow around each of the features 9220"' during, for example, an overmolding or bonding process in order to secure the plate 9210-B to or in the material. In some examples, the plate 9210-B can include one or more recesses (e.g., features 9220') and / or protrusions (e.g., features 9220") in combination with the features 9220"'. FIG. 8C FIG. 9A

[0539] FIG. 9B ​​A plurality of mushroom or T-shaped features 9220-A are shown. The features 9220-A can include a base 9221 and a top 9222. The base 9221 can have a width that is less than a width of the top 9222. The base 9221 and the top 9222 can be integrally formed and / or can be separate components that are coupled together. During overmolding or bonding, material can flow around or between the features 9220-A, e.g., around the base 9221. In some examples, material can flow around the base 9221 and the top 9222, e.g., to completely encapsulate the features 9220-A within the material. The narrower shape of the features 9220-A closer to the major surfaces of the first layer 9212-B and / or the third layer 9216-B can facilitate the engagement of the material with the board 9210-B.

[0540] FIG. 9C An optional protrusion 9220-B is shown. The protrusion 9220-B can be configured similar to an inverted cone or truncated cone. For example, the protrusion 9220-B includes a top surface 9223 and a side surface 9224. The side surface 9224 can be angled inwardly. For example, the top surface 9223 can have a width that is greater than a width of a base of the protrusion 9220-B. During overmolding or bonding, material can flow around or between the protrusion 9220-B, e.g., around the side surface 9224. In some examples, material can flow around the side surface 9224 and, e.g., on the top surface 9223, to completely encapsulate the protrusion 9220-B within the material. Again, the narrower shape of the features 9220-B closer to the major surfaces of the first layer 9212-B and / or the third layer 9216-B can facilitate the engagement of the material with the board 9210-B.

[0541] FIG. 10A An optional protrusion 9220-C is shown. The protrusion 9220-C can be L-shaped. For example, the protrusion 9220-C can include a first portion 9225 that is coupled to an outer surface of the first layer 9212-B. An arm 9226 can extend laterally outwardly from the first portion 9225 (e.g., at a perpendicular angle to the first portion 9225 or at an angle greater than or less than 90 degrees). During overmolding or bonding, material can flow around or between the protrusion 9220-C, e.g., around the first portion 9225. In some examples, material can flow around the first portion 9225 and, e.g., on the arm 9226, to completely encapsulate the protrusion 9220-C within the material. The narrower shape of the features 9220-C closer to the major surfaces of the first layer 9212-B and / or the third layer 9216-B can facilitate the engagement of the material with the board 9210-B.

[0542] The protrusions 9220-A, 9220-B, and / or 9220-C can be disposed across the outer surface of the first layer 9212-B and / or the third layer 9216-B. For example, the protrusions 9220-A, 9220-B, and / or 9220-C can be randomly disposed across the outer surface of the first layer 9212-B and / or the third layer 9216-B. In some examples, the protrusions 9220-A, 9220-B, and / or 9220-C can be disposed in a pattern (e.g., a series of rows, columns, diagonals, etc.) across the first layer 9212-B and / or the third layer 9216-B. Alternatively, one or more discrete portions of the outer surface of the first layer 9212-B and / or the third layer 9216-B can include the protrusions 9220-A, 9220-B, and / or 9220-C. For example, the outer periphery of the first layer 9212-B and / or the third layer 9216-B can include the protrusions 9220-A, 9220-B, and / or 9220-C, the corners of the first layer 9212-B and / or the third layer 9216-B, and / or the central region of the first layer 9212-B and / or the third layer 9216-B can include the protrusions 9220-A, 9220-B, and / or 9220-C. In some examples, the first layer 9212-B can include a first type of protrusion 9220-A, 9220-B, and / or 9220-C, and the third layer 9216-B can include a second type of protrusion 9220-A, 9220-B, and / or 9220-C. Alternatively, the first layer 9212-B and / or the third layer 9216-B can include a combination of protrusion types. Although mushroom-shaped, frustoconical, and L-shaped protrusion types are described herein, any protrusion having a width that decreases as it approaches the first layer 9212-B and / or the third layer 9216-B can be suitable to increase the material's engagement with the board 9210-B.

[0543] FIG. 10B is a perspective view of a portion of an alternative board 9210-C. FIGS. 10C-10E is a cross-sectional view of the board 9210-C. The board 9210-C can have any or all of the features of the boards 9210, 9210-A, and / or 9210-B described above, unless otherwise described below. For example, the board 9210-C can 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 the board 9210-C can have any or all of the properties of the corresponding layers 9212, 9214, 9216 of the board 9210 and / or the layers 9212-A, 9214-A, 9216-A of the board 9210-A. For example, the second layer 9214-C can be disposed between the first layer 9212-B and the third layer 9216-C. The second layer 9214-C can include a conductive material, such as copper. The first layer 9212-C and / or the third layer 9216-C can include a polyimide material or any of the other materials described above.

[0544] The plate 9210-C can include one or more through holes 9228. The through holes 9228 can extend through each of the first layer 9212-C, the second layer 9214-C, and the third layer 9216-C. The through holes 9228 can extend directly through each of the first layer 9212-C, the second layer 9214-C, and the third layer 9216-C.

[0545] During overmolding or bonding, material can flow on the plate 9210-C and can flow through the through holes 9228. Once solidified or otherwise set or hardened, the material located in the through holes 9228 can extend through the second layer 9214-C and connect the first layer 9212-C to the third layer 9216-C. This connection of material through the through holes 9228 can further secure the material to the plate 9210-C and create a mechanical interlock. When the material is subjected to an external force, the material through the through holes 9228 can act as an anchor that would otherwise cause the material to peel off the plate 9210-C.

[0546] FIG. 10C Alternative configurations of the through holes 9228 are shown. For example, FIG. 10D A through hole 9228-A having a frustoconical shape is shown. The through hole 9228-A can have an inner surface 9230. The through hole 9228-A can be configured such that a width of the through hole 9228-A on a first side of the plate 9210-C is less than a width of the through hole 9228-A on a second side of the plate 9210-C.

[0547] FIG. 10E A through hole 9228-B having a funnel shape is shown. For example, a first portion 9232 of the through hole 9228-B can be substantially straight, for example, through a first portion of the plate 9210-C. The first portion 9232 of the through hole 9228-B can extend a first depth through the plate 9210-C. A second portion 9233 of the through hole 9228-B can extend a second depth through the plate 9210-C. The first portion 9232 of the through hole 9228-B can have a first width. The second portion 9233 of the through hole 9228-B can have a second, increased width. For example, a diameter of the second portion 9233 of the through hole 9228-B can increase as the through hole extends from a first side of the plate 9210-C to a second side of the plate 9210-C.

[0548] FIGS. 10C-10EA through-hole 9228-C with a T-shape is shown. For example, a first portion 9234 of the through-hole 9228-C can be substantially straight, e.g., through a first portion of the plate 9210-C. The first portion 9234 of the through-hole 9228-C can extend through the plate 9210-C a first depth. A second portion 9235 of the through-hole 9228-C can extend through the plate 9210-C a second depth. The first portion 9234 of the through-hole 9228-C can have a first width. The second portion 9235 of the through-hole 9228-C can have a second width. The first width can be less than the second width.

[0549] The through-holes 9228, 9228-A, 9228-B, and / or 9228-C can extend through the entire plate 9210-C. In some examples, the plurality of through-holes 9228, 9228-A, 9228-B, and / or 9228-C can be arranged in a pattern (e.g., a series of rows, columns, diagonals, etc.) or randomly across the plate 9210-C. Alternatively, one or more discrete portions of the plate 9210-C can include the through-holes 9228, 9228-A, 9228-B, and / or 9228-C. For example, an outer periphery of the plate 9210-C can include the through-holes 9228, 9228-A, 9228-B, and / or 9228-C, corners of the plate 9210-C, and / or a central region of the plate 9210-C can include the through-holes 9228, 9228-A, 9228-B, 9228-C.

[0550] In other examples, FIGS. 7A to 10EThe depicted through-holes 9228-A, 9228-B, and / or 9228-C can extend through the first layer 9212-C and / or the third layer 9216-C, but not through the second layer 9214-C. For example, a wider portion of each of the through-holes 9228-A, 9228-B, and / or 9228-C can be positioned relatively closer to the second layer 9214-C than a narrower portion of each of the through-holes 9228-A, 9228-B, and / or 9228-C, which can extend through an outer surface of the first layer 9212-C and / or the third layer 9216-C. The widening of the through-holes 9228-A, 9228-B, and / or 9228-C in the interior of the first layer 9212-C and / or the third layer 9216-C can allow material flowing on the plate 9210-C during an overmolding or bonding process to flow into the through-holes 9228-A, 9228-B, and / or 9228-C. Once solidified or otherwise set or hardened, the material located in the through-holes 9228-A, 9228-B, and / or 9228-C can have a widened lip or flange within the interior region of the first layer 9212-C and / or the third layer 9216-C that engages with the first layer 9212-C and / or the third layer 9216-C and can further secure the material to the plate 9210-C and create a mechanical interlock.

[0551] Each example discussed herein, e.g., in FIG. 11 may be used alone or in combination with one or more techniques. For example, one or more different materials or surface treatments (e.g., primers, adhesives, etching, etc.), features, through-holes, etc. can be used alone or in combination with one another. Various combinations are contemplated, e.g., to enhance or improve adhesion between the plate 9210 and components of the respiratory therapy system 8000 (e.g., the patient interface 3000) or other materials that are contained within the respiratory therapy system 8000.

[0552] FIG. 12 A packaged chip 1200 is shown. For example, the packaged chip 1200 includes a substrate 1202, a plate (or chip) 1210, and a cover 1204. The plate 1210 can have any or all of the features of the plates 9210, 9210-A, 9210-B, and / or 9210-C described above. The substrate 1202 and the cover 1204 can encapsulate the plate 1210, e.g., to form a liquid-tight seal.

[0553] FIG. 13A flowchart showing an exemplary method 1300 for forming an encapsulated chip 1200 is shown. In a first step 1301, a substrate 1202 can be formed, e.g., molded. For example, the substrate 1202 can be injection molded or otherwise formed. The substrate 1202 can be formed of a soft or flexible plastic or silicone material. In some examples, the substrate 1202 can be formed of a hard or rigid material. The substrate 1202 can be clear or transparent. In some examples, the substrate 1202 can be colored and / or opaque.

[0554] In a second step 1302, the board 1210 can be placed on the substrate 1202. In some examples, the board 1210 can be adhered to the substrate 1202, e.g., using an adhesive. The board 1210 can be placed on the substrate 1202 such that the width of the substrate 1202 is greater than the width of the board 1210. For example, the board 1210 can be placed in a central region of the substrate 1202.

[0555] In a third step 1303, a cap 1204 can be formed, e.g., on the board 1210 and / or the substrate 1202, to encapsulate the board 1210 between the substrate 1202 and the cap 1204. For example, the cap 1204 can be formed by overmolding an additional substrate on the substrate 1202 and the board 1210. In this way, the encapsulated chip 1200 is formed.

[0556] In a fourth step 1304, the encapsulated chip 1200 can be coupled to a component of the respiratory therapy system 8000, e.g., a patient interface 3000 (e.g., a cushion), a conduit 4170, etc. For example, the encapsulated chip 1200 can be bonded to or overmolded with the component. In some aspects, the entire component or a portion of the component can have the chip 1200 overmolded thereon.

[0557] Multiple injection molding or insert molding can be used in the methods 1300 described herein.

[0558] FIG. 14A An alternative configuration of an encapsulated chip 2200 is shown. In such a configuration, the board or chip 1210 can be placed on or coupled to a surface of a component 1206 of the respiratory therapy system 8000, e.g., a patient interface 3000, a conduit 4170, etc. For example, the board 1210 can be placed on a cushion of the patient interface 3000. In some aspects, the board 1210 can have an adhesive backing similar to a sticker to allow the board 1210 to adhere to the component 1206. Once the board 1210 is placed on the surface of the component 1206, a UV adhesive or other suitable material can be applied over the board 1210, e.g., to encapsulate the board 1210 and form the encapsulated chip 2200. The UV adhesive can form a layer or dome over the board 1210, e.g., to seal the board 1210 and bond the board 1210 to the surface of the component.

[0559] FIG. 6 and 14B An example patient interface 3000’ is depicted. The patient interface 3000’ can be used as, for example, the patient interface 3000 of the system 8000 described above with reference to FIG. 14A FIG. 14B A rear view of the patient interface 3000’ is shown, FIG. 14A A top view of the patient interface 3000’ is shown. The patient interface 3000’ is generally referred to as a nasal patient interface or a full-face patient interface. For example, the patient interface 3000’ can be configured to cover the mouth and nose of a patient, or only the nose of a patient.

[0560] FIG. 14A and 14B The dots are included to better illustrate and describe the various portions of the patient interface 3000’ that will be described herein. However, the dots are for the purpose of description and do not necessarily indicate that the different portions of the patient interface 3000’ include different materials, properties, or colors, although in one example, the different portions can include different materials, properties, or colors.

[0561] The patient interface 3000’ has a three-dimensional shape that can vary depending on the style or type of patient interface. For example, the size and shape of the patient interface 3000’ can be quite different from the size and shape shown in FIG. 14A and 14B The portions of the patient interface 3000’ can be formed from rigid or hard materials, and other portions of the patient interface 3000’ can be formed from soft or pliable materials. Thus, the placement of an RFID tag, such as the tag 9200, on the patient interface 3000’ presents unique considerations. As described above, the tag 9200 can include the board 9210.

[0562] ​The patient interface 3000’ includes a housing 3002 having a first portion 3002A, a second portion 3002B, a third portion 3002C, and a fourth portion 3002D. One or more portions of the housing 3002 (e.g., the first portion 3002A, the second portion 3002B, and the third portion 3002C) can be formed of a rigid material (e.g., polycarbonate) and can not contact the patient’s skin. One or more portions of the housing 3002 (e.g., the fourth portion 3002D) can be formed of a softer, more pliable material (e.g., silicone rubber). The first portion 3002A includes an opening 3008. The opening 3008 extends the entire thickness of the housing 3002 and is configured to directly or indirectly couple the patient interface 3000’ to a proximal portion of the air circuit 4170. The opening 3008 is aligned with the median plane M of the patient interface. The first portion 3002A surrounds the opening 3008. The second portion 3002B and the third portion 3002C surround the first portion 3002A.

[0563] The label 9200 can be positioned near the opening 3008 in a “tube down” configuration of the patient interface 3000’, as shown in FIGS. 21A and 21B. FIG. 5K FIG. 14A and 5M A similar “tube down” configuration of the label 9200 can also be depicted in similar positions). For example, the label 9200 can be coupled to the first portion 3002A, the second portion 3002B, the third portion 3002C, or the fourth portion 3002D. In some aspects, the label 9200 can be placed on or near the third portion 3002C due to the proximity of the opening 3008, which can be an ideal positioning for the patient interface 3000’. The third portion 3002C is proximate or adjacent to the median plane M. For example, the label 9200 can be placed on one side (i.e., left or right) defined by the median plane M, or on the other side (i.e., right or left) defined by the median plane M, or along the median plane M. In some configurations, the label 9200 can be positioned to straddle multiple portions of the patient interface 3000’. For example, a first portion of the label 9200 can be on the first portion 3002A of the housing 3002, a second portion of the label 9200 on the second portion 3002B and / or the third portion 3002C of the housing 3002. As such, the placement of the label 9200 can vary between the first portion 3002A, the second portion 3002B, the third portion 3002C, and / or the fourth portion 3002D.

[0564] ​The tag 9200 can be placed on or in the housing 3002 in various ways. For example, the tag 9200 can be a chip 9210 overmolded into the housing 3002, as described above. Alternatively, the tag 9200 can be printed directly on the housing 3002 by printed conductive material, such as silver ink. The tag 9200 can be an inlay tag overmolded into the housing 3002. In such examples, the tag 9200 (e.g., inlay tag) can be inserted into a cavity of a mold for the housing 3002, for example, via automation, and injection molding and plastic can be injected onto the inlay tag, thereby securing the inlay tag within or on the housing 3002. Alternatively, the tag 9200 can be formed from conductive silicone and / or conductive wire printed on the housing 3002. In further alternatives, the tag 9200 can be formed from conductive fabric with stretchable copper traces. Thus, the tag 9200 can be formed by any one of these methods or any combination of these methods, including those well known in the art. Moreover, the tag 9200 can be a separate component secured to the housing 3002 by various suitable means well known in the art, including, but not limited to, adhesive and / or one or more mechanical fasteners.

[0565] The patient interface 3000 also includes a cushion 3006 configured to contact the patient’s face. The cushion 3006 can be formed from a soft or pliable material, such as silicone rubber. The cushion 3006 is configured to form a seal against the patient’s face. While the tag 9200 can be placed on or in the cushion 3006, it can be less desirable to place the tag 9200 on or in the cushion 3006 due to challenges related to the distance of the cushion 3006 from the opening 3008 and / or challenges related to one or more properties of the material that makes up the cushion 3006 (e.g., flexibility, softness, thickness, etc. of the material). Additionally or alternatively, placing the tag 9200 on or in the cushion 3006, e.g., between the patient’s skin and the cushion 3006, can cause patient discomfort. That is, the tag 9200 can be positioned in the cushion 3006.

[0566] While FIG. 15A and 14BA patient interface 3000’ is shown with the tube pointing downward and the location of the label 9200 near the opening 3008 is discussed, but a patient interface with the tube pointing upward can also be used in accordance with the technology. In the tubular patient interface 3000’, the location of the label 9200 can be, for example, closer to the upper region of the patient interface 3000’. In some aspects, the location of the label 9200 on the patient interface 3000’ can depend at least in part on whether the patient interface 3000’ is in a tube-up configuration or a tube-down configuration in order to position the label 9200 closer to the proximal portion of the air circuit 4170 and the antenna 9100 when attached to the patient interface 3000’.

[0567] FIG. 6 and 15B An alternative example patient interface 3000” is described. For example, the patient interface 3000” can be used with the system 8000 described with reference to FIG. 15A The patient interface 3000” can be used with the system 8000 described with reference to FIG. 15B A back view of the patient interface 3000” is shown, FIG. 15A A top view of the patient interface 3000” is shown. The patient interface 3000’ is generally referred to as a nasal pillow. For example, the patient interface 3000” can be configured to be partially inserted into a patient’s nose.

[0568] FIG. 16A and 15B Dots are included to better show and describe the various portions of the patient interface 3000” that will be described herein. However, the dots are for the purpose of description and do not necessarily indicate that the different portions of the patient interface 3000” include different materials, properties, or colors, although in one example, the different portions can include different materials, properties, or colors.

[0569] The patient interface 3000” has a complex three-dimensional shape. For example, the patient interface 3000” includes various curves and contours. Portions of the patient interface 3000” can be formed from soft or pliable materials, while other portions of the patient interface 3000” can be formed from hard or rigid materials. For example, portions of the patient interface 3000” that contact the patient’s face can be soft or pliable, and portions used to facilitate the connection between the air circuit 4170 and the patient interface 3000” can be hard or rigid. In addition, the patient interface 3000” is smaller in size compared to the patient interface 3000’ described above. As a result, the placement of the label 9200 on the patient interface 3000” presents unique considerations.

[0570] The patient interface 3000” includes a first nasal pad 3012A and a second nasal pad 3012B located on either side of the midline plane M. For example, the first nasal pad 3012A is on a first (e.g., left or right) or medial side of the midline plane M, while the second nasal pad is on a second (e.g., right or left) medial side of the midline plane M. The first nasal pad 3012A and the second nasal pad 3012B are configured to be at least partially inserted into a patient’s nare and are thus dermal contacting. As such, the material comprising the first nasal pad 3012A and the second nasal pad 3012B can be soft and pliable (e.g., silicone rubber). Additionally, the first nasal pad 3012A and the second nasal pad 3012B each include a first hole 3014A and a second hole 3014B extending through an entire thickness of the first nasal pad 3012A and the second nasal pad 3012B, respectively, such that the first nasal pad 3012A and the second nasal pad 3012B are in fluid connection with a lumen 3016 of the tubular portion 3018. The lumen 3016 extends through the tubular portion 3018, e.g., from a first side 3020A of the tubular portion 3018 to a second side 3020B of the tubular portion 3018. The tubular portion 3018 includes a first portion 3018A, a second portion 3018B, and a third portion 3018C.

[0571] The first nasal pad 3012A and the second nasal pad 3012B extend radially outward from the first portion 3018A. The first portion 3018A can be composed of the same material as the first nasal pad 3012A and the second nasal pad 3012B or a different material. The first nasal pad 3012A and the second nasal pad 3012B are configured to form a seal between a patient’s skin.

[0572] The second portion 3018B is located on either side of the first portion 3018A. For example, the second portion 3018B is located on a left side and a right side of the first portion 3018A. The second portion 3018B can be composed of the same material as the first portion 3018A or a different material. The second portion 3018B is not configured to form a seal with a patient’s skin and can not be configured to contact a patient’s skin.

[0573] A third portion 3018C is located outward of each second portion 3018B. For example, the third portion 3018C is located to the left of the first portion 3018A and to the right of the second portion 3018B. The third portion 3018C includes a first side 3020A and a second side 3020B. The third portion 3018C can not be configured to contact the patient’s skin. Accordingly, the third portion 3018C can be composed of a harder or more rigid material. In a tubular down patient interface 3000”, the air circuit 4170 can be connected to the patient interface 3000” at the first portion 3018A, which is generally opposite the first and second nasal pads 3012A, 3012B. Alternatively, in a tubular patient interface 3000”, the air circuit 4170 can be attached to a conduit head cover, which can be attached to the third portion 3018C. In some aspects, the location of the tag 9200 on the patient interface 3000” can depend at least in part on whether the patient interface 3000” is employed in a tube up configuration or a down tube configuration, so as to position the tag 9200 closer to the proximal portion of the air circuit 4170 and the antenna 9100 when attached to the patient interface 3000”.

[0574] In use of the patient interface 3000”, the air circuit 4170 with the antenna 9100 can be connected to the patient interface 3000”. The tag 9200 can be located near the connection location of the air circuit 4170. For example, the tag 9200 can be coupled to the first portion 3018A, the second portion 3018B, or the third portion 3018C. In some aspects, to avoid contact with the patient’s skin, the tag 9200 can be coupled to the second portion 3018B or the third portion 3018C. In some configurations, the tag 9200 can be positioned to straddle multiple portions of the patient interface 3000’. For example, a first portion of the tag 9200 can be on the second portion 3018B and a second portion of the tag 9200 can be on the third portion 3018C. In this way, the location of the tag 9200 can vary between the first portion 3018A, the second portion 3018B, and the third portion 3018C.

[0575] Due to challenges associated with contact with the patient’s skin, it can be less desirable to place the tag 9200 on or in the first nasal pad 3012A, the second nasal pad 3012B, and / or the first portion 3018A in some aspects. Additional or alternative challenges can be associated with one or more properties of the material comprising the first and second nasal pads 3012A, 3012B (e.g., material flexibility, softness, thickness, etc.). Additionally or alternatively, placing the tag 9200 on or in the first and second nasal pads 3012A, 3012B, for example, between the patient’s skin and the first or second nasal pad 3012A, 3012B, can cause discomfort to the patient.

[0576] The tag 9200 can be placed on or in the patient interface 3000" in a variety of ways, similar to the ways described above for securing the tag 9200 to the patient interface 3000'. For example, the tag 9200 can be a chip overmolded within the tubular portion 3018, as described above. Alternatively, the tag 9200 can be printed directly onto the tubular portion 3018 by printed conductive ink (e.g., silver ink). The tag 9200 can be an inlay tag overmolded within the tubular portion 3018. In such examples, the tag 9200 (e.g., inlay tag) can be inserted into a cavity of a mold for the tubular portion 3018, for example, via automation, and the mold and plastic can be injected onto the inlay tag, thereby securing the inlay tag within or on the tubular portion 3018. Alternatively, the tag 9200 can be formed from conductive silicone and / or conductive wire printed on the tubular portion 3018. In further alternatives, the tag 9200 can be formed from a conductive fabric with stretchable conductive (e.g., copper) traces. Thus, the tag 9200 can be formed by any one of these methods or any combination of these methods, including those known in the art. Further, the tag 9200 can be a separate component secured to the tubular portion 3018 by various suitable means known in the art, including but not limited to adhesive and / or one or more mechanical fasteners.

[0577] During use of the patient interface 3000, 3000', 3000" or another suitable patient interface (collectively, the patient interface 3000), the air circuit 4170 can be fluidly coupled to the RPT device 4000 and the patient interface 3000. As described above, the RPT device 4000 can be configured to supply a flow of gas, such as air that can be supplemented with oxygen, to the patient interface 3000 through the air circuit 4170. The RPT device 4000 can also be configured to receive a signal from the RFID system 9000 upon the air circuit 4170 being coupled to the patient interface 3000 (e.g., via the data communication interface 4280 and / or the central controller 4230). The signal can include information about the patient interface 3000 or an accessory. For example, the antenna 9100 or the adapter 9400 in the air circuit 4170 can detect the tag 9200 in the patient interface 3000 and can read information about the patient interface 3000 associated with the tag 9200. This information can be transmitted to the RPT device 4000 (e.g., to the data communication interface 4280) via the transceiver 9300, for example.

[0578] In some aspects, the received information can be one or more of: e.g., a type of patient interface 3000 used, a characteristic of the patient interface 3000 (e.g., one or more of a cushion material, a cushion size, a conduit size, a patient interface size, a length of use of the patient interface, a date of manufacture of the patient interface, a set of respiratory therapy conditions for which the patient interface is suitable for use with, etc.), a date or time stamp of use, a batch identification number of the patient interface 3000, or a serial identification number of the patient interface 3000. In some aspects, the received information can be one or more of patient information, e.g., a type or setting of therapy that the patient wants to receive, or other information. In some aspects, the received information can be whether or not a supply circuit 4170 and / or an accessory device (not shown) is connected or disconnected from the patient interface 3000.

[0579] The RPT device 4000 can be configured to perform an action upon receiving information about the patient interface 3000 from the RFID system 9000. For ease of description herein, the RPT device 4000 can be described as performing an action based on receipt of information, however, this can mean that a controller incorporated as part of the RPT device 4000 (e.g. the central controller 4230 and / or the therapy control module 4330) can cause the RPT device to perform the action, or a controller separate from the RPT device 4000 can cause the RPT device 4000 to perform the action. For example, the RPT device 4000 can automatically control operation of therapy provided to the patient based on the received information or signals (e.g. via the central controller 4230 and / or the therapy control module 4330, as described above). For example, the respiratory experience can be improved by determining whether the settings of the RPT device (e.g. airflow, humidity level, etc.) are correctly aligned with the patient interface worn by the patient. In some configurations, the RPT device 4000 can implement a design of patient interface specific ventilation and flow profiles to facilitate more comfortable and / or effective therapy delivery. In some aspects of the technology, an indication to the patient can be generated based on the information received by the RPT device 4000. For example, an indication can be generated that the type or size of patient interface being used is incorrect, that the cushion 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 indication. The indication can be generated, for example, on one or more displays of the RPT device 4000 or other components of the system 8000, to an external device such as the remote external device 4286 or the local external device 4288 (e.g. a patient tablet, smartphone or computer, or a health care provider’s device). In other aspects, the respiratory therapy system 8000 can receive input from the patient, for example, the patient can input information about the patient interface 3000 during a therapy session, and the input received from the patient can be compared to the information received from the patient interface 3000 in the RFID system 9000 to confirm the accuracy of the patient input. In some aspects, the information received from the RFID system 9000 can be used to track usage or other characteristics of the patient interface in use.

[0580] In other aspects of the present technology, information received from the patient interface 3000 can be received by the RPT device 4000 in addition to information received from other sensors or systems associated with the system 8000. For example, sensors or systems configured to detect air flow, pressure, air leaks, humidity, or other characteristics of the system 8000 can send information to the RPT device 4000. The RPT device 4000 can analyze or interpret information received from the RFID system 9000 about the patient interface 3000 in conjunction with one or more other sensors. For example, information can be received from the RFID system 9000 about the type or size of the patient interface being worn or how long the patient interface has been in use. The system 8000 can also receive information from other sensors or patient input about patient interface discomfort or leak occurrence.

[0581] The system 8000 can analyze this information together and can take action based on the collective information. For example, if patient interface discomfort is indicated by the patient or a leak is detected by the patient interface, based on information received from the RFID system 9000, the RPT device 4000 can generate an indication to the patient that a different size or type of patient interface should be used, that a different size or type of cushion should be used, or that a new patient interface or cushion should be used. The indication can include, for example, a recommendation about the type or size of patient interface or cushion to use or guidance on how to select a better fitting cushion or patient interface type or size. The indication can be generated to an external device, such as a remote external device 4286 or a local external device 4288 (e.g., a patient tablet, smartphone, or computer, or a health care provider’s device), on one or more of the displays of the RPT device 4000, such as the display 4294, or other components of the system 8000, as described above. In other aspects, one or more settings of the RPT device 4000 can be changed based on the collective information received from the RFID system 9000 and other information from the system 8000. In some aspects, the indication can be that the air circuit 4170 is not coupled to the patient interface 3000 or is not properly coupled to the patient interface 3000.

[0582] In some aspects, the system 8000 can indicate to the patient when the patient interface or cushion has been worn for a sufficient length of time, or is a production batch identification number or serial identification number that is sufficiently old that performance can be affected, and a new patient interface or cushion should be used. In some aspects, the age of the patient interface or how many times the patient interface has been used can result in an indicator that a new patient interface or new cushion should be used. The system 8000 can indicate to the patient to replace the patient interface or cushion. The indication can also depend at least in part on a recommended period of use for the particular patient interface or cushion type, the type of therapy being administered to the patient, or one or more other factors. The indication can be generated as described above, for example on one or more of the display of the RPT device 4000 (e.g. the display 4294) or other components of the system 8000, to an external device (e.g. a tablet, smartphone or computer of the patient, or a device of a healthcare provider) such as the remote external device 4286 or the local external device 4288, or to a cloud server such as the remote external communication network 4282 and / or the local external communication network 4284 and / or the remote external communication network 4282 (e.g. for remote monitoring, to improve the patient experience, to trigger an order (such as for a new patient interface or accessory, etc.).

[0583] The antenna 9100 and transceiver 9300 can read the signal from the tag 9200 at least once during a therapy session. For example, the tag 9200 can be read when therapy is initiated, for example when a start button is pressed or when an automatic start is initiated. In some aspects, the RFID system 9000 can continue to read, for example continuously or at regular intervals, if no accessory or air circuit 4170 is detected attached to the patient interface 3000. In some configurations of the technology, the signal from the tag 9200 can be read periodically, for example every few seconds, minutes or hours. In some examples of the technology, the antenna 9100 and transceiver 9300 can read the signal from the tag 9200 according to a regular or irregular frequency. For example, the signal can be read at the start of a session or after a predetermined amount of time, more or less frequently. In some aspects, the frequency can increase if an unexpected read occurs or in the event of a failed read. In some aspects, the type of therapy being administered or the type of patient interface being used can at least partially determine the frequency at which the tag 9200 is read.

[0584] FIG. 16B A perspective cross-sectional view of a portion of a headgear tube 3350’ is shown, the headgear tube 3350’ configured for delivery of pressurized air received from a conduit forming a portion of the air circuit 4170. FIGS. 18-20A cross-sectional view of a headgear tube 3350' is shown. The headgear tube 3350' can be used with a nasal mask and / or a nasal only mask, in a tube up or tube down configuration. For example, the headgear tube 3350' can be used with any suitable patient interface 3000' described above. The wall 3007 of the headgear tube 3350' can be formed from a soft or pliable material, such as silicone rubber. The headgear tube 3350' can be hollow. During use, a first lumen 3008 of the headgear tube 3350' can convey fluid (e.g., gas or air) to the user. The cross-sectional shape of the headgear tube 3350' can vary. For example, the headgear tube 3350' can have a generally elliptical cross-section, a circular cross-section, or the like.

[0585] An inner surface 3007A of the wall 3007 can define the first lumen 3008. An outer surface 3007B can include a pair of arms 3009 extending radially outward from the outer surface 3007B and toward one another. The arms 3009A, 3009B can extend an entire length of the headgear tube 3350' (as also shown in FIG. 17A The arms 3009 can extend less than the entire length of the headgear tube 3350', for example, for one or more discrete lengths on the headgear tube 3350', in some examples. The first arm 3009A can extend outward from the outer surface 3009B and toward the second arm 3009B. The second arm 3009B can extend outward from the outer surface 3007B and toward the first arm 3009A. Each arm 3009A, 3009B can be bendable. Each arm 3009A, 3009B can have a respective free end 3011A, 3011B. Similarly, each arm can have a respective fixed end 3012A, 3012B that is fixed to the outer surface 3007B. For example, the first arm 3009A can include the fixed end 3012A and the free end 3011A, and the second arm 3009B can include the fixed end 3012B and the free end 3011B. The free ends 3011A, 3011B of each respective arm 3009A, 3009B can meet or contact to form a second lumen 3010. In some examples, the free ends 3011A, 3011B can be glued or otherwise bonded together, for example, such that the second lumen 3010 is closed or sealed.

[0586] In some examples, the free ends 3011A, 3011B of each respective arm 3009A, 3009B can not meet. For example, a channel 3013 can be formed between each first arm 3009A and second arm 3009B. In some examples, the channel 3013 can be filled with a material (e.g., adhesive, epoxy, silicone, or the like) to seal or close the lumen 3010.

[0587] A device 3014 can extend through the second lumen 3010. The device 3014 can be, for example, a cable associated with the antenna 9100 and / or the tag 9200. The device 3014 can also be the antenna 9100 and / or the tag 9200. The device 3014 can be fixed within the second lumen 3010 or can be loosely disposed within the second lumen 3010. For example, in some aspects, an epoxy, silicone, and / or adhesive can fill the second lumen 3010 to secure the device 3014 in place within the second lumen 3010.

[0588] FIG. 17B A perspective cross-sectional view of a portion of another headgear tube 3350" is shown. FIG. 16A A cross-sectional view of the headgear tube 3350" is shown. The headgear tube 3350" can be used with a nasal mask and / or a nasal only mask. The headgear tube 3350" can have any or all of the features of the headgear tube 3350', unless otherwise described below. For example, the headgear tube 3350" can be used with the patient interface 3000', as described above. The wall 3007' of the headgear tube 3350" can be formed from a soft or pliable material, such as silicone rubber.

[0589] The inner surface 3007A' of the wall 3007' can define a first lumen 3008'. The outer surface 3007B' can include a single arm 3009' extending radially outward from the outer surface 3007B'. The arm 3009' can be flexible or bendable. The arm 3009' can extend an entire length of the headgear tube 3350". In some examples, the arm 3009' can extend less than an entire length of the headgear tube 3350", for example, for one or more discrete lengths on the headgear tube 3350". The arm 3009' can have a free end 3011A' and a fixed end 3012'. The fixed end 3012' can be fixed to the outer surface 3007B'.

[0590] The arm 3009' can be bent such that the free end 3011' contacts or abuts the outer surface 3007B' to form a second lumen 3010'. In some examples, the free end 3011' can be glued or otherwise bonded to the outer surface 3007B', for example, such that the second lumen 3010' is closed or sealed. In some examples, the free end 3011' can be adhered to the outer surface 3007B', for example, with an adhesive, epoxy, silicone, or the like, to seal or close the second lumen 3010'.

[0591] A device 3014 can extend through the second lumen 3010'. The device 3014' can have any of the properties of the device 3014. For example, the device 3014' can be a wire, a cable, an electrical connection, the antenna 9100, and / or the tag 9200. The device 3014' can be fixed within the second lumen 3010' or can be loosely disposed within the second lumen 3010'. For example, an epoxy, a silicone, and / or an adhesive can fill the second lumen 3010' to secure the device 3014' in place within the second lumen 3010'.

[0592] FIG. 16A 、 16B One or more aspects of the pair of arms 3009A, 3009B and the lumen 3010 of the FIG. 17A 、 16B The arm 3009' and the lumen 3010' of the FIG. 16A 、 17B The pair of arms 3009 or the arm 3009' can be used, for example, to manage one or more wires, cables, or electrical connections (e.g., the device 3014, 3014') associated with the antenna 9100 and / or the tag 9200. Additionally or alternatively, the pair of arms 3009 or the arm 3009' can be used to couple or secure one or more wires, cables, electrical connections, antennas 9100, or tags 9200 to the patient interface (e.g., the cushion and / or to the surface of the patient interface). Additionally or alternatively, FIG. 17A 、 16B The pair of arms 3009A, 3009B and the lumen 3010 of the FIG. 18 、 17B The arm 3009' and the lumen 3010' of the

[0593] FIG. 5J Examples of the technology described in the context of an example tube-up patient interface are shown. As previously described, the respiratory therapy system 8000 can 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 can be configured for use with a tubular patient interface, such as the patient interface 3000 FIG. 5Lpatient interface 3000-1 or FIG. 5K patient interface 3000-3, such as a full-face, nasal or pillow tubular patient interface.

[0594] The tube-up patient interface 3000' can include one or more radio frequency identification (RFID) tags and / or antennas incorporated on or in the patient interface 3000'. For example, the RFID tags and / or antennas can be incorporated with one or more of the pillow or other seal-forming structure 3100 of the patient interface 3000', the conduit (e.g., headgear tube 3350) of the patient interface 3000', or near the connection point to the air circuit. The RFID tags and / or antennas can be incorporated on or in the patient interface 3000' (or other components of the respiratory therapy system 8000, as previously discussed) using any of the methods or devices discussed herein.

[0595] Aspects of the technology described herein can involve including an extended tag and / or antenna portion within a tube-up patient interface having a stretchable portion (e.g., a corrugated accordion portion, such as the extendable accordion structure 3362 described above). For example, the stretchable portion of the extended tag and / or antenna can be used, for example, to facilitate communication between the RFID tag, antenna, and / or transceiver. Although the technology disclosed in this section is discussed with respect to a tube-up configuration, the technology can also be used in a tube-down configuration (e.g., the patient interface 3000-2 or 3000-4). FIG. 5M patient interface 3000-2 or FIG. 18 3000-4).

[0596] In one example, referring to FIG. 18The first tag 9200A can be associated with the conduit head cover 4180 and can be configured to store identification data for the conduit head cover 4180. The second tag 9200B can be associated with the patient interface 3000’ or the cushion of the patient interface 3000’ and can be configured to store identification data for the patient interface 3000’ and / or the cushion of the patient interface 3000’. Upon connecting the air circuit 4170 to the conduit head cover 4180, the first antenna 9100A can detect the first tag 9200A and receive the identification data for the conduit head cover 4180. The third antenna 9100C can detect the second tag 9200B and receive the identification data for the patient interface 3000’ or the cushion of the patient interface 3000’, which can then be transmitted along the electrical connection 9105 to the second antenna 9100B, which can include a flexible printed circuit board. The first antenna 9100A can then read the data from the second antenna 9100B. Although two tags 9200 are shown in the figures, in some aspects, only one tag 9200 can be included in the RFID system 9000. In other aspects, more than two tags can be included in the RFID system 9000, such as three, four, five, or more tags.

[0597] Reference can be made to FIG. 6 Any of the tags 9200 and / or antennas 9100 described can include a flexible printed circuit board. In some embodiments, the first tag 9200A can include an adhesive, a primer, or can be otherwise configured, for example, to facilitate adhesion to the conduit head cover 4180 and / or to hold the first tag 9200A in place on the conduit head cover 4180 after application. In some aspects, the first tag 9200A can be overmolded onto or within a portion of the conduit head cover 4180 or integrally formed on a portion of the conduit head cover 4180, as described above. For example, the first tag 9200A including a flexible printed circuit board can be overmolded to a silicone conduit head cover 4180 using any of the methods described above, such as using one or more features 9220, vias 9228, encapsulation, adhesives, primers, material selection, surface treatment, etc.

[0598] Similarly, the second tag 9200B can include an adhesive, primer, or can be otherwise configured, e.g., to facilitate adhesion to the patient interface 3000’, and / or to hold the second tag 9200B in place on the patient interface 3000’ (or cushion) after application. The second tag 9200B can alternatively be overmolded onto or within a portion of the patient interface 3000’ or integrally formed on a portion of the patient interface 3000’, as described above. For example, the second tag 9200B including a flexible printed circuit board can be overmolded to a silicone portion of the patient interface 3000’ using any of the methods described above, e.g., using one or more features 9220, vias 9228, encapsulation, adhesives, primers, material selection, surface treatment, etc.

[0599] The RFID system 9000 can include one first tag 9200A fixedly or removably coupled to the conduit head cover 4180 and / or one second tag 9200B fixedly or removably coupled to the patient interface 3000’ or an accessory device (not shown). Alternatively, the RFID system 9000 can include two or more first tags 9200A fixedly or removably coupled to the conduit head cover 4180 and / or two or more second tags 9200B fixedly coupled to the patient interface 3000 or an accessory device (not shown). The first tag 9200A and / or the second tag 9200B described herein can be an off-the-shelf component or can be customized according to the size and / or shape of the patient interface 3000 or the conduit head cover 4180 and / or according to a desired read range of the first tag 9200A and the second tag 9200B.

[0600] The first antenna 9100A can be configured to receive data from the second antenna 9100B and the first tag 9200A. The first antenna 9100A is further configured to transmit the data received from the second antenna 9100B and the first tag 9200A to the transceiver or reader 9300 (as shown). The transceiver 9300 can be operably connected to the first antenna 9100A, e.g., physically (via a wire), and can be located on the overhead circuit 4170. In one configuration, the transceiver 9300 can be external to the respiratory therapy system 8000. For example, the transceiver 9300 can be a scanner, a smart phone, a tablet, or any other device configured to receive RFID signals transmitted from an RFID tag or antenna. Thus, the first antenna 9100A is configured to communicate data received from one or more tags 9200 to the transceiver 9300. The transceiver 9300 can be further configured to save or store the data transmitted from the first antenna 9100A. FIG. 18

[0601] ​Transceiver 9300 can relay information from first antenna 9100A to a controller (e.g., central controller 4230 and / or treatment control module 4330) configured to control RPT device 4000. The controller can be separate from or integrated with RPT device 4000. The controller can operate as described above. In some configurations, transceiver 9300 can be configured to physically (e.g., via wire) or wirelessly transmit data to RPT device 4000. RPT device 4000 can also be configured to save or store data transmitted from transceiver 9300, interpret transmitted data, and / or send alarms or signals to the user or care provider, as described above. In some embodiments, RPT device 4000 can also be configured to automatically change one or more characteristics of respiratory pressure therapy, for example, based on raw and / or interpreted data received from transceiver 9300. Alternatively or additionally, the RPT device 4000 may be configured to suggest one or more treatment settings, for example, to facilitate patient care and / or patient comfort based on interpreted data from the transceiver 9300, as will be discussed further below.

[0602] Despite FIG. 18 As not shown, transceiver 9300 can be combined with first antenna 9100A. For example, transceiver 9300 and first antenna 9100A can form a single combined component. The combined component may have any or all of the characteristics of the first antenna 9100A and transceiver 9300 described above. For example, the combined first antenna 9100A and transceiver 9300 can be configured to send or receive data to, for example, a controller of RPT device 4000 (such as central controller 4230).

[0603] FIG. 16A A perspective view of an exemplary patient interface 3000' and catheter headgear 4180 is shown. The patient interface 3000' can be used with the system 8000 described above. The catheter headgear 4180 is a catheter or tube constructed and arranged to allow airflow to travel between two components of the respiratory therapy system, such as the air circuit 4170 and the patient interface 3000', during use.

[0604] The proximal portion 4170A of the air circuit 4170 can be coupled to the second portion 4180B of the catheter head 4180. The air circuit 4170 can be coupled to the catheter head 4180 via, for example, a connector 4190. The connector 4190 allows the air circuit 4170 to rotate and move while still maintaining the connection between the air circuit 4170 and the catheter head 4180. In an alternative embodiment, the air circuit 4170 is directly connected to the catheter head 4180.

[0605] The conduit head cover 4180 can bifurcate or branch into a first portion 4180A and a second portion 4180B. A distal portion of the first portion 4180A of the conduit head cover 4180 can include a flexible or stretchable portion, such as a first accordion portion 4200A, and the second portion 4180B of the conduit head cover 4180 can include a flexible or stretchable portion, such as a second accordion portion 4200B. For purposes of this specification, the first accordion portion 4200A and the second accordion portion 4200B can be substantially identical. For example, the first accordion portion 4200A can extend a first length along the first portion 4180A of the conduit head cover 4180, and the second accordion portion 4200B can extend the same length along the second portion 4180B of the conduit head cover 4180. Each of the first accordion portion 4200A and the second accordion portion 4200B can be corrugated. Thus, the first accordion portion 4200A and / or the second accordion portion 4200B can, for example, extend and / or compress to adjust the conduit head cover 4180 to a patient’s face. The first accordion portion 4200A and / or the second accordion portion 4200B can extend along an entire length of the conduit head cover 4180, or can extend along less than an entire length of the conduit head cover 4180, such as along a majority of the length of the conduit head cover 4180, or less than a majority of the length of the conduit head cover 4180.

[0606] For example, due to the flexibility and stretchability of the conduit head cover 4180, it can be challenging to incorporate wires (e.g., between two or more antennas 9100 and / or tags 9200) extending along the conduit head cover 4180. In particular, due to the material comprising the conduit head cover 4180 (e.g., silicone), and / or due to the corrugated features of the first accordion portion 4200A and / or the second accordion portion 4200B, it can be difficult to incorporate electrical connections 9105 comprising flexible printed circuit boards on or within the conduit head cover 4180. In some examples, the electrical connections 9105 can need to remain at the correct antenna impedance while being stretchable. One or more of these challenges can be addressed by aspects of the technology described herein. For example, the antennas and / or electrical connections 9105 comprising flexible printed circuit boards can be overmolded to the silicone portions of the patient interface 3000’ using any of the methods described above, such as using one or more of the features 9220, the vias 9228, the encapsulation, the adhesive, the primer, the material selection, the surface treatment, etc. In some examples, the electrical connections 9105 can comprise one or more flexible materials (e.g., polyimide or another amorphous plastic, TPU, PET, and / or a silicone membrane).

[0607] In some examples, the first antenna 9100A can be disposed on or within a proximal portion 4170A of the air circuit 4170. The second antenna 9100B can be disposed on or within a distal portion of a conduit head set 4180 configured to be coupled to the air circuit 4170. The first tag 9200A can be adjacent or proximate to the first antenna 9100A, for example within a second portion 4180B of the conduit head set 4180. A distal end of the electrical connection 9105 is coupled to the second antenna 9100B. The electrical connection 9105 can extend from the second antenna 9100B on or within a distal portion of a first portion 4180A of the conduit head set 4180 to a proximal portion of the first portion 4180A. The electrical connection 9105 can extend external to the conduit head set 4180 or can extend within a material comprising the conduit head set 4180 or within a coating applied to the conduit head set 4180. As described above, the first antenna 9100A, the electrical connection 9105, and / or the second antenna 9100B can be overmolded to, for example, a silicone conduit head set 4180 using any of the techniques described herein.

[0608] As described above with reference to FIG. 16A , 16B , 17A and 17B, the conduit head set 4180 can include one or more arms extending radially outward from a surface of the conduit head set 4180 to form a second lumen. For example, an entire length or one or more discrete lengths of the conduit head set 4180 can include a pair of arms (e.g., similar to the pair of arms 3009 discussed above with reference to FIG. 16A and 16B . The pair of arms of the conduit head set 4180 can form a second lumen, for example, similar to the second lumen 3010 of FIG. 17A and 16B . In some examples, the electrical connection 9105 can be disposed within the second lumen of the conduit head set 4180. Alternatively, an entire length or one or more discrete lengths of the conduit head set 4180 can include a single arm (e.g., similar to the single arm 3009' discussed above with reference to FIG. 17A and 17B . The single arm of the conduit head set 4180 can form a second lumen, for example, similar to the second lumen 3010' of FIG. 18 and 17B . In some examples, the electrical connection 9105 can be disposed within the second lumen of the conduit head set 4180. As such, the electrical connection 9105 can not be located within an airflow passageway of the conduit head set 4180.

[0609] In some examples, a proximal end of the electrical connection 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, e.g., within a proximal portion of the first portion 4180A of the conduit headgear 4180. The proximal end of the first portion 4180A of the conduit headgear 4180 can be directly or indirectly coupled to the patient interface 3000’. The second tag 9200B can be associated with the patient interface 3000’, the cushion, or one or more other accessories. Although the electrical connection 9105 and the third antenna 9100C are described with reference to the first portion 4180A, the second portion 4180B can also include similar structures, and the conduit headgear can be substantially symmetrical. However, in some aspects, one of the first portion 4180A or the second portion 4180B can include the third antenna 9100C and the electrical connection 9105, while the other of the first portion 4180A or the second portion 4180B can not.

[0610] In one aspect, to accommodate the flexible stretchability of the first accordion portion 4200A and the second accordion portion 4200B, the electrical connection 9105 can extend along a serpentine path. As shown, the electrical connection 9105 forms a plurality of curves 9106. The plurality of curves 9106 can extend along a portion of the electrical connection 9105 or along the entirety of the electrical connection 9105. For example, the plurality of curves 9106 can extend along at least the first accordion portion 4200A. FIG. 7A

[0611] Each curve of the plurality of curves 9106 can be the same or similar in size. Alternatively, one or more curves of the plurality of curves 9106 can be different in size. For example, one or more curves of the plurality of curves 9106 can be larger or smaller to accommodate a curvature of the conduit headgear 4180 or a change in corrugation of the accordion portion. By arranging the electrical connection 9105 to have a plurality of curves 9106, or for example, to be arranged in a zig-zag or serpentine path, stretching or bending of the conduit headgear 4180 can result in a relatively small increase in tension on the electrical connection 9105. This configuration can also reduce the chance of failure of the electrical connection 9105 due to repeated stretching and / or bending cycles.

[0612] In another aspect, the electrical connection 9105 itself can have a coiled or serpentine configuration to allow for stretchability. The electrical connection 9105 having a coiled or serpentine configuration can extend along a more direct path from the second antenna 9100B to the third antenna 9100C, or can follow a serpentine or zig-zag path. The electrical connection 9105 itself can or can not be formed of a stretchable material.

[0613] ​In another example, the electrical connection 9105 can be integrated in the material comprising the conduit head cover 4180. For example, the electrical connection 9105 can be overmolded or otherwise formed with the conduit head cover 4180. In this way, the electrical connection 9105 can be composed of one or more flexible materials (e.g., polyimide or another amorphous plastic, TPU, PET, and / or silicone film). For example, the electrical connection 9105 can be formed as an extended flexible printed circuit board comprising at least three layers. For example, the electrical connection 9105 and each of its layers can have any or all of the properties discussed above with respect to FIG. 7A , 7B , 8A-8C, 9A-9C, 10A-10E, and / or 11. The electrical connection 9105 can include any or all of the features described above in order to improve adhesion of the electrical connection 9105 on or within the conduit head cover 4180 and / or the sleeve 9107. Incorporating any or all of the features discussed above with respect to FIG. 18 , 7B , 8A-8C, 9A-9C, 10A-10E, and / or 11 in conjunction with the electrical connection 9105 can, for example, improve adhesion of the electrical connection 9105 on or within the conduit head cover 4180.

[0614] In some aspects, the electrical connection 9105 can be formed of a flexible conductive material, such as a flexible printed circuit board, and can be incorporated on or within the sleeve 9107 (e.g., a silicone rubber sleeve), as shown in the stippled portion of FIG. 19 The sleeve 9107 can cover the conduit head cover 4180 and can be removable relative to the conduit head cover 4180, or the sleeve 9107 can be fixedly coupled to an outer surface of the conduit head cover 4180 (e.g., coupled to the first portion 4180A of the conduit head cover 4180 or coupled to both the first portion 4180A and the second portion 4180B of the conduit head cover 4180). The sleeve 9107 can surround (e.g., wrap around) a portion of the conduit head cover 4180 or around an entire circumference of the conduit head cover 4180. Additionally or alternatively, the sleeve 9107 can extend along an entire length of the first portion 4180A and the second portion 4180B of the conduit head cover 4180 or less than an entire length thereof. In some aspects, the sleeve 9107 can cover a majority or substantially all of an outer surface of the conduit head cover 4180, including, for example, around an opening in the conduit head cover 4180 configured to be coupled to the air circuit 4170.

[0615] The sleeve 9107 can be composed of one or more materials. For example, the sleeve 9107 can be composed of one or more of a flexible conductive silicone, conductive fibers or wires, stretchable conductive fabric, or other suitable material or combination of materials. The material can include conductive traces, such as copper traces, or conductive fibers or wires that can be printed, heat bonded, stitched, or otherwise incorporated onto or into the material. In some aspects, a metal gel flex circuit can be used to form the electrical connections 9105. The metal gel flex circuit can include a film that can be incorporated into a fabric version of the sleeve 9107. Additionally, the metal gel flex circuit can include one or more stabilizing additives to allow the material to withstand high pressure lamination and heat welding processes without displacement. The metal gel flex circuit can be configured to withstand bending, stretching, or twisting.

[0616] The sleeve 9107 can be composed of a flexible material and / or a stretchable material, and can include or be configured to accommodate a bellows portion, such as the first accordion portion 4200A and / or the second accordion portion 4200B of the conduit head sleeve 4180. For example, the sleeve 9107 can be configured to be extended or stretched and compressed to accommodate changes in the length of the first portion 4180A or the second portion 4180B of the conduit head sleeve 4180.

[0617] Additionally or alternatively, the sleeve 9107 can also include a second antenna 9100B and a third antenna 9100C. For example, the second antenna 9100B can be arranged on or within a first end of the sleeve 9107 (e.g., proximate or adjacent to the attachment location of the air circuit 4170), and / or the third antenna 9100C can be arranged on or within a second end of the sleeve 9107 (e.g., proximate or adjacent to the patient interface 3000’). If the sleeve 9107 is configured to cover both the first portion 4180A and the second portion 4180B of the conduit head sleeve 4180, one or more additional antennas can be arranged on or within the sleeve 9107, such as if an approximately symmetrical antenna extension is provided along both the first portion 4180A and the second portion 4180B of the conduit head sleeve 4180.

[0618] FIG. 7AA top perspective view of an exemplary portion of the conduit head cover 4180 is shown. In this configuration, the second antenna 9100B is looped or wrapped around the opening 4182, with the air return circuit 4170 configured to be coupled to the conduit head cover 4180. The second antenna 9100B can be, for example, integrated into the material from which the conduit head cover 4180 is manufactured around the opening 4182, can be printed, heat bonded, adhered, or coated around the opening 4182, or can be integrated into a sleeve, such as a fabric sleeve, that fits over the conduit head cover 4182 and around the opening 4182. The opening 4182 is configured to be coupled (e.g., directly or indirectly) to the air return circuit 4170. Although not shown, in some configurations, the first antenna 9100A is looped or wrapped around a corresponding opening on the air return circuit 4170.

[0619] To accommodate the corrugations of the first telescoping portion 4200A, the electrical connection 9105 can include a distal portion 9105A having a plurality of curves 9106. The plurality of curves 9106 can extend along an entire length of the first telescoping portion 4200A or along a portion of the first telescoping portion 4200A. Thus, the plurality of curves 9106 can include one curve, two curves, three curves, etc. The plurality of curves 9106 can enable the electrical connection 9105 to extend and / or contract as the first telescoping portion 4200A expands and / or contracts, for example. The electrical connection 9105 including the plurality of curves 9106 can be formed from a stretchable conductive silicone. In some embodiments, the stretchable conductive silicone can be a wire or fiber that is printed, heat bonded, adhered, overmolded, or coated onto the material from which the conduit head cover 4180 is formed.

[0620] Additionally or alternatively, the electrical connection 9105 can be formed from a stretchable conductive fabric having printed conductive, such as copper traces. The stretchable conductive fabric having printed conductive traces, such as copper traces, can be heat bonded to the conduit head cover 4180, which can be formed from silicone, for example. Additionally or alternatively, a metal gel flex circuit can be used to form the electrical connection 9105. The metal gel flex circuit can include a film that can be bonded to the conduit head cover 4180, which can be formed from a silicone component. Alternatively, the metal gel flex circuit can include a film that can be bonded to a fabric. Further, the metal gel flex circuit can include one or more stabilizing additives to allow the material to withstand high pressure lamination and heat welding processes without displacement. The metal gel flex circuit can be configured to withstand bending, stretching, or twisting. Any one or combination of these materials can be used to form and bond the electrical connection 9105 and / or one or more antennas to the conduit head cover 4180.

[0621] In some examples, the electrical connection 9105 can be integrated within the material comprising the conduit head cover 4180, as discussed above. For example, the electrical connection 9105 can be overmolded or otherwise formed with the conduit head cover 4180, which can be silicone rubber. In this way, the electrical connection 9105 can be composed of one or more flexible materials (e.g., polyimide or another amorphous plastic, TPU, PET, and / or silicone film). For example, the electrical connection 9105 can be formed as an extended flexible printed circuit board comprising at least three layers. For example, the electrical connection 9105 and each of its layers can have any or all of the properties discussed above with respect to FIG. 7A 、 7B , 8A-8C, 9A-9C, 10A-10E, and / or 11. The electrical connection 9105 can include any or all of the features described above in order to improve adhesion of the electrical connection 9105 on or within the conduit head cover. Incorporating any or all of the features discussed above with respect to FIG. 20 、 7B , 8A-8C, 9A-9C, 10A-10E, and / or 11 in conjunction with the electrical connection 9105 can, for example, improve adhesion of the electrical connection 9105 on or within the conduit head cover 4180.

[0622] FIG. 18 The patient interface 3000’, the conduit head cover 4180, and the air circuit 4170 are shown in fluid communication with one another when worn by a patient. For example, the conduit head cover 4180 is configured such that the air circuit 4170 is coupled to the conduit head cover 4180 at or near the top of the patient’s head, e.g., via the fitting 4190. The air circuit 4170 can be rotatable relative to the conduit of the head cover 4180 through the fitting 4190. For example, the fitting 4190 can be a swivel fitting, allowing the air circuit 4170 to be rotated relative to the conduit head cover 4180. Additionally, the conduit head cover 4180 and the air circuit 4170 can be angled relative to one another. For example, the air circuit 4170 can be angled at approximately 90 degrees relative to the conduit head cover 4180 through the fitting 4190. Thus, in some aspects, a first antenna 9100A that can be fixed in or on a proximal end portion of the air circuit 4170 can be angled relative to a second antenna 9100B that is fixed in or on the conduit head cover 4180.

[0623] As previously discussed, the electrical connection 9105 physically and electrically couples the second antenna 9100B to the third antenna 9100C. The electrical connection 9105 can include a plurality of curves 9106( FIG. 7A and 19), thereby allowing the electrical connection 9105 to extend and / or retract, for example, as the first accordion portion 4200A extends and / or retracts. In this way, signals from the third antenna 9100C can be transmitted to the second antenna 9100B via the electrical connection 9105.

[0624] As discussed above, the electrical connection 9105 can include a plurality of curves 9106. As shown, the plurality of curves 9106 can extend along a portion of the electrical connection 9105. By arranging the electrical connection 9105 to have a plurality of curves 9106, or for example, to have such a zig-zag / serpentine path, stretching or bending of the conduit head cover 4180 can result in a relatively small increase on the electrical connection 9105. This can allow for the use of an electrical connection 9105 that has a relatively small stretch or a stretchable electrical connection 9105. Such a configuration can also reduce the chance of failure of the electrical connection 9105 due to repeated stretching and / or bending cycles.

[0625] As discussed above, the electrical connection 9105 can be integrated in the material comprising the conduit head cover 4180, which can be silicone rubber. For example, the electrical connection 9105 can be overmolded or otherwise formed with the conduit head cover 4180. In this way, the electrical connection 9105 can be composed of one or more flexible materials (e.g., polyimide or another amorphous plastic, TPU, PET, and / or silicone membrane). For example, the electrical connection 9105 can be formed as an extended flexible printed circuit board comprising at least three layers. For example, the electrical connection 9105 and each of its layers can have any or all of the properties discussed above with respect to FIG. 7A 、 7B , 8A-8C, 9A-9C, 10A-10E, and / or 11. The electrical connection 9105 can include any or all of the features discussed above with respect to ​ 、 7B , 8A-8C, 9A-9C, 10A-10E, and / or 11 to improve adhesion of the electrical connection 9105 on or in the conduit head cover 4180.

[0626] Embodiments discussed herein can enable a user to detect the identity of a patient interface or accessory that is in use. Embodiments discussed herein can include an RFID device, such as an RFID tag. Additionally or alternatively, embodiments discussed herein can include one or more electrical wires, cables, or other conductive elements configured to transmit an electrical signal. Embodiments discussed herein can enable the RFID tag and / or electrical wires / cables / conductive elements to be coupled to one or more components of a respiratory therapy system.

[0627] 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 disclosure herein. The specification and examples are to be considered exemplary only, with the true scope and spirit of the disclosure indicated by the claims that follow.

Claims

1. A respiratory therapy system comprising: a patient interface; and a radio frequency identification tag secured to the patient interface, characterized in that the radio frequency identification tag comprises a flexible circuit board, the flexible circuit board comprises a first layer, a second layer, and a third layer, the second layer is arranged between the first layer and the third layer, the second layer comprises a first surface and a second surface opposite the first surface, the first layer comprises a cover layer attached to the first surface of the second layer, the third layer comprises a cover layer attached to the second surface of the second layer, and the second layer comprises an electrically conductive material.

2. The respiratory therapy system of claim 1, wherein, the first layer and / or the third layer comprises a polyimide or another amorphous plastic, a thermoplastic polyurethane, a polyethylene terephthalate, and / or a silicone membrane.

3. The respiratory therapy system of any one of claims 1 to 2, wherein, the first layer and / or the third layer comprises an outer surface having an improved bond strength, an improved adhesion ability, a higher surface roughness, and / or an improved coupling ability relative to an inner surface of the first layer and / or the third layer, and an inner surface of the first layer and / or the third layer is secured to the second layer.

4. The respiratory therapy system of any one of claims 1 to 2, wherein, the first layer and / or the third layer comprises an etching configured to roughen an outer surface of the first layer and / or the third layer.

5. The respiratory therapy system of any one of claims 1 to 2, wherein, the first layer and / or the third layer comprises one or more features on an outer surface thereof.

6. The respiratory therapy system of claim 5, wherein, the one or more features comprises a recess or a protrusion.

7. The respiratory therapy system of claim 6, wherein, the one or more features comprises the protrusion, and the protrusion has a frustoconical shape, an L-shape, and / or a mushroom shape.

8. The respiratory therapy system of any one of claims 1 to 2, wherein, the first layer and / or the third layer has at least one through hole extending therethrough.

9. The respiratory therapy system of any one of claims 1 to 2, wherein, the respiratory therapy system further comprises at least one through hole extending through the first layer, the second layer, and the third layer.

10. The respiratory therapy system of any one of claims 1 to 2, wherein, the respiratory therapy system further comprises a silicone material at least partially surrounding the flexible circuit board.

11. The respiratory therapy system of any one of claims 1 to 2, wherein, the flexible circuit board is encapsulated.

12. A respiratory therapy system comprising: an air circuit; and a radio frequency identification tag secured to the air circuit, characterized in that the radio frequency identification tag comprises a flexible circuit board, the flexible circuit board comprises a first layer, a second layer, and a third layer, the second layer is arranged between the first layer and the third layer, the second layer comprises a first surface and a second surface opposite the first surface, the first layer comprises a cover layer attached to the first surface of the second layer, the third layer comprises a cover layer attached to the second surface of the second layer, and the second layer comprises an electrically conductive material.

13. The respiratory therapy system of claim 12, wherein, the first layer and / or the third layer comprises a polyimide or another amorphous plastic, a thermoplastic polyurethane, a polyethylene terephthalate, and / or a silicone membrane.

14. The respiratory therapy system of any one of claims 12 to 13, wherein, the first layer and / or the third layer comprises an outer surface having an improved bond strength, an improved adhesion ability, a higher surface roughness, and / or an improved coupling ability relative to an inner surface of the first layer and / or the third layer, and an inner surface of the first layer and / or the third layer is secured to the second layer.

15. The respiratory therapy system of any one of claims 12 to 13, wherein, The first layer and / or the third layer includes an etch configured to roughen an outer surface of the first layer and / or the third layer.

16. The respiratory therapy system of any one of claims 12 to 13, wherein, The first layer and / or the third layer includes one or more features on an outer surface thereof.

17. The respiratory therapy system of claim 16, wherein, The one or more features include a depression or a protrusion.

18. The respiratory therapy system of claim 17, wherein, The one or more features include the protrusion, and the protrusion has a frustoconical shape, an L-shape, and / or a mushroom shape.

19. The respiratory therapy system of any one of claims 12 to 13, wherein, The first layer and / or the third layer has at least one through-hole extending therethrough.

20. The respiratory therapy system of any one of claims 12 to 13, wherein, The respiratory therapy system further includes at least one through-hole extending through the first layer, the second layer, and the third layer.

21. The respiratory therapy system of any one of claims 12 to 13, wherein, The respiratory therapy system further includes a silicone material at least partially surrounding the flexible circuit board.

22. The respiratory therapy system of any one of claims 12 to 13, wherein, The flexible circuit board is encapsulated.

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