Conductive fabric tube or conduit

Abstract

An air conduit for a system for treating respiratory disorders includes a fabric outer layer and at least one inner layer including a polymer layer. At least one of the outer fabric layer is a conductive fabric and / or the inner layer includes a conductive coating. The conduit may form an air circuit and / or part of a headgear of a patient interface. An air conduit having an electrically conductive intermediate layer is also disclosed.

Description

TECHNICAL FIELD 1.1 TECHNICAL FIELD

[0002] The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention and amelioration of a respiratory-related disorder. The present technology also relates to medical devices or apparatus, and their use. BACKGROUND

[0003] 1.2 DESCRIPTION OF RELATED ART

[0004] 1.2.1 The Human Respiratory System and Its Disorders

[0005] The respiratory system of the body facilitates gas exchange. The nose and mouth form entry points to the airways of a patient. It is through these entry points that air passes to the lungs.

[0006] The airways include a sequence of branching tubes that become narrower, shorter, and more numerous as they penetrate deeper into the lung. The primary 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 in turn divide into a tree of successively smaller bronchi, bronchioles and ultimately terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles, and ultimately the pulmonary alveoli. The pulmonary alveoli region of the lung is where gas exchange occurs, and is known as the respiratory zone. See John B. West, Respiratory Physiology, 9thedition, Lippincott Williams & Wilkins, 2012.

[0007] There is a range of respiratory disorders. Certain disorders can be characterised by particular events, such as apneas, hypopneas, and hyperpneas.

[0008] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD), and Chest Wall Disorder.

[0009] 1.2.2 Therapy

[0010] Various respiratory therapies have been used to treat one or more of the above-listed respiratory disorders. These include Continuous Positive Airway Pressure (CPAP), Non-Invasive Ventilation (NIV), Invasive Ventilation (IV), and High Flow Therapy (HFT).

[0011] 1.2.2.1 Respiratory Pressure Therapy

[0012] Respiratory pressure therapy is the application of air to the entrance of the airways 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 tank ventilators or chest cuirass ventilators).

[0013] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnoea (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 therapy if they find the device used to provide this therapy to be one or more of the following: uncomfortable, difficult to use, expensive and unattractive.

[0014] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airways to assist the patient's breathing and / or maintain adequate oxygen levels in the body by doing some or all of the work of breathing. The ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, which takes the form of conditions such as OHS, COPD, NMD and Chest Wall Disorder. In some forms, the comfort and effectiveness of these therapies can be improved.

[0015] Invasive ventilation (IV) provides ventilatory support to a patient who is no longer able to breathe effectively on their own, and can be provided using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0016] 1.2.2.2 Flow therapy

[0017] Not all respiratory therapies aim to deliver a prescribed treatment pressure. Some respiratory therapies aim to deliver a prescribed respiratory volume by delivering an inspiratory flow rate profile over a target duration (possibly superimposed on a positive baseline pressure). In other cases, the interface to the patient's airways is "open" (unsealed) and the respiratory therapy can supplement the patient's own spontaneous breathing with a flow of conditioned or enriched gas. In one example, high flow therapy (HFT) can be the provision of a continuous, heated, humidified flow of air at a "treatment flow rate" that is approximately constant throughout the respiratory cycle, through an unsealed or "open" patient interface to the entrance of the airways. 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 rate of air at the entrance of the airways improves ventilation efficiency by flushing or washing out exhaled C02 from the patient's anatomic dead space. HFT is therefore sometimes referred to as deadspace therapy (DST). Other benefits can include elevated warmth and humidity (possibly beneficial in secretion management) and the possibility of modestly elevating airway pressures. As an alternative to a constant flow rate, the treatment flow rate can follow a profile that varies over the respiratory cycle.

[0018] Another form of flow therapy is long term oxygen therapy (LTOT) or supplemental oxygen therapy. A physician can prescribe a continuous flow of enriched air at a specified oxygen concentration (from 21% of the oxygen fraction in ambient air to 100%) at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.) to be delivered to the patient's airways.

[0019] 1.2.2.3 Supplemental oxygen

[0020] For certain patients, oxygen therapy can be combined with respiratory pressure therapy or HFT by adding supplemental oxygen to the pressurized 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.

[0021] 1.2.3 Respiratory therapy system

[0022] These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used to screen for, diagnose, or monitor a disorder without treating it.

[0023] 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.

[0024] 1.2.3.1 Patient interface

[0025] A patient interface can be used to interface a respiratory treatment apparatus to its wearer, such as 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 of a patient, 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, for example, a seal with a region of the patient’s face to facilitate the delivery of gas at a pressure sufficiently different from ambient pressure to effect therapy, such as at a positive pressure of about 10 cmH20 relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the patient interface can not include a seal sufficient to facilitate the delivery of gas to the airways at a positive pressure of about 10 cmH20. 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.

[0026] 1.2.3.2 Respiratory pressure therapy (RPT) device

[0027] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to deliver one or more of a number of therapies described above, such as by operating the device to generate a flow of air for delivery to an interface to the airways. The flow of air can be pressure-controlled (for respiratory pressure therapies) or flow-controlled (for flow therapies such as HFT). Thus, an RPT device can also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0028] 1.2.3.3 Air circuit

[0029] 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 branches of the air circuit for inhalation and exhalation. In other cases, a single branch air circuit is used for inhalation and exhalation.

[0030] In many examples of the prior art, an air circuit can include one or more heating elements configured to heat air in the air circuit, such as to maintain or raise the temperature of the air. The heating element can be in the form of a heating wire loop (typically of copper wire), and can include one or more transducers, such as temperature sensors. In one form, the heating wire loop can be helically wound around an axis of the air circuit. The heating element can be in communication with a controller, such as a central controller of an RPT device. One example of an air circuit including a heating wire loop is described in US Patent 8,733,349, which is incorporated herein in its entirety by reference.

[0031] While such heating elements can work well to prevent condensation (so-called "rainout") within the air circuit, they can add weight to the air circuit and can increase the complexity of manufacturing the air circuit.

[0032] 1.2.3.4 Humidifier

[0033] Delivery of a flow of non-humidified air can cause drying of the airways. The use of a humidifier with an RPT device and patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases comfort to the patient's airways. In addition, in cooler climates, warm air, which is typically applied to the facial area inside and around the patient interface, is more comfortable than cold air.

[0034] 1.2.4 Screening, diagnosis and monitoring systems

[0035] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardio-respiratory disorders, and typically involves a clinical specialist to apply the system. PSG typically involves placing 15 to 20 contact sensors on a patient in order to record various body signals such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep disordered breathing involves a two-night observation of a patient in a clinic, one night purely for diagnosis, and the second night for titration of therapy parameters by a clinician. PSG is therefore both expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep disordered breathing.

[0036] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening generally 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 progression of a condition can continue indefinitely. Some screening / diagnosis systems are suitable only for screening / diagnosis, whereas some can also be used for monitoring.

[0037] A clinical specialist can be able to adequately screen, diagnose or monitor a patient from visual observation of PSG signals. However, there are circumstances where a clinical specialist can not be available or can not be affordable. Different clinical specialists can have different opinions on a patient's condition. Furthermore, a given clinical specialist can apply different criteria at different times. SUMMARY

[0038] The present technology aims to provide medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders, with one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0039] A first aspect of the present technology relates to apparatus for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders.

[0040] Another aspect of the technology relates to methods for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0041] One aspect of certain forms of the technology is to provide methods and / or devices that improve patient compliance with respiratory therapy.

[0042] One form of the technology comprises a positioning and stabilising structure configured to provide a force to hold a seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilising structure comprises at least one strap.

[0043] One form of the technology comprises a patient interface comprising a plenum chamber, a seal-forming structure, and a positioning and stabilising structure.

[0044] One form of the technology comprises a patient interface comprising a plenum chamber pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure. The plenum chamber comprises at least one plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient. The patient interface also comprises a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways. The seal-forming structure has a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares. The seal-forming structure is constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout a patient's respiratory cycle in use. The patient interface also comprises 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.

[0045] Another aspect of one form of the technology is a series of modular elements that can be interconnected to form different styles of patient interface.

[0046] In one form, each modular element has at least two versions or styles. These versions or styles can be used interchangeably with one another to form different modular assemblies.

[0047] One form of the technology comprises a tube comprising an outer layer of fabric and at least one inner layer comprising a polymer layer, wherein the outer fabric layer is an electrically conductive fabric and / or at least one of the inner layers comprises an electrically conductive coating.

[0048] One form of the technology comprises an air conduit for a system for treating a respiratory disorder, the air conduit comprising an outer layer of fabric and at least one inner layer comprising a polymer layer, wherein the outer fabric layer is an electrically conductive fabric and / or at least one of the inner layers comprises an electrically conductive coating.

[0049] In an example:

[0050] a) the fabric layer comprises at least one electrically conductive fiber;

[0051] b) the fabric layer is formed by circular knitting or weaving, and at least one of the weft yarns is an electrically conductive fiber;

[0052] c) the fabric layer is formed by conventional knitting or circular knitting, and at least one of the warp yarns is an electrically conductive fiber;

[0053] d) the fabric is formed by a braiding process, and at least one of the yarns is an electrically conductive fiber;

[0054] e) the polymer layer comprises at least one trace formed from an electrically conductive ink, paste or gel or liquid metal;

[0055] f) the air conduit comprises a further inner layer between the polymer layer and the fabric layer;

[0056] g) the further inner layer comprises an electrically conductive element;

[0057] h) the electrically conductive element comprises a flexible printed circuit board (PCB), one or more wires or a piece of electrically conductive material;

[0058] i) at least one of the inner layer and / or the electrically conductive fabric is configured to conduct an electrical signal;

[0059] j) at least one of the inner layer and / or the electrically conductive fabric is configured to conduct electrical power;

[0060] k) at least one of the inner layer and / or the electrically conductive fabric is configured to heat the air conduit when conducting an electrical current;

[0061] l) the air conduit comprises at least one sensor and / or at least one antenna, wherein the at least one sensor and / or at least one antenna is electrically connected to the electrically conductive fabric and / or electrically conductive coating;

[0062] m) the air conduit forms part of an air circuit; and / or

[0063] n) the air conduit forms part of a headgear for a patient interface.

[0064] Another form of the present technology comprises an air conduit for a system for treating a respiratory disorder, the air conduit comprising a fabric outer layer, at least one inner layer comprising a polymer layer, and at least one electrically conductive intermediate layer.

[0065] Preferably:

[0066] a) the intermediate layer comprises a flexible printed circuit board (PCB), one or more wires and / or a piece of electrically conductive material;

[0067] b) the electrically conductive intermediate layer is configured to conduct an electrical signal;

[0068] c) the electrically conductive intermediate layer is configured to conduct electrical power;

[0069] d) the electrically conductive intermediate layer is configured to heat the air conduit when conducting electrical current;

[0070] e) the air conduit comprises at least one sensor and / or at least one antenna, wherein the at least one sensor and / or at least one antenna is electrically connected to the electrically conductive intermediate layer;

[0071] f) the air conduit forms part of an air circuit; and / or

[0072] g) wherein the air conduit forms part of a headgear for a patient interface.

[0073] Another aspect of one form of the technology is a patient interface that is molded or otherwise constructed to have a perimeter shape that is complementary to a perimeter shape of an intended wearer.

[0074] One aspect of one form of the technology is a method of manufacturing an apparatus.

[0075] Another aspect of one form of the technology is a method of assembling a modular system, including selecting a positioning and stabilising structure, and connecting the positioning and stabilising structure to a first cushion or a second cushion.

[0076] One aspect of certain forms of the technology is a medical device that is easy to use, for example by a person who is not medically trained, by a person who has limited dexterity, by a person who has limited vision, or by a person who has limited experience in using this type of medical device.

[0077] One aspect of one form of the technology is a portable RPT device that can be carried by a person, for example in the person’s home.

[0078] One aspect of one form of the technology is a patient interface that can be washed in a patient’s home, for example in soapy water, without requiring specialised cleaning equipment. One aspect of one form of the technology is a humidifier water tank that can be washed in a patient’s home, for example in soapy water, without requiring specialised cleaning equipment.

[0079] The described methods, systems, devices and apparatuses can be implemented in order to improve the functioning of processors, such as processors of special purpose computers, respiratory monitors and / or respiratory therapy apparatuses. Furthermore, the described methods, systems, devices and apparatuses can provide improvements in the technical field of the automated management, monitoring and / or treatment of respiratory disorders, including for example sleep disordered breathing.

[0080] Of course, parts of these aspects can form sub-aspects of the technology. Furthermore, sub-aspects and / or individual aspects among the aspects can be combined in various ways, and also constitute additional aspects or sub-aspects of the technology.

[0081] Other features of the technology will be apparent from consideration of the following detailed description, abstract, drawings and claims. BRIEF DESCRIPTION OF DRAWINGS

[0082] The technology is illustrated in the drawings in example and non-limiting specific embodiments thereof, in which like numerals denote like elements throughout the several views, including:

[0083] 3.1 RESPIRATORY THERAPY SYSTEM

[0084] FIG. 1A A system including a patient 1000 wearing a patient interface 3000 in the form of a nasal pillows, receiving a supply of air at positive pressure from an RPT device 4000 is shown. 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.

[0085] FIG. 1B A system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask, receiving a supply of air at positive pressure from an RPT device 4000 is shown. Air from the RPT device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000.

[0086] FIG. 1C A system including a patient 1000 wearing a patient interface 3000 in the form of an full-face mask, receiving a supply of air at positive pressure from an RPT device 4000 is shown. 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.

[0087] 3.2 RESPIRATORY SYSTEM AND FACIAL ANATOMY

[0088] FIG. 2 A diagrammatic illustration of the human respiratory system including nasal cavities and oral cavities, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm is shown.

[0089] 3.3 PATIENT INTERFACE

[0090] FIG. 3A A patient interface in the form of a nasal mask according to one form of the technology is shown.

[0091] FIG. 3BA patient interface is shown having a conduit headgear in accordance with one form of the present technology.

[0092] 3.4 Air conduit

[0093] FIG. 4 is a schematic side view of a portion of an air conduit of the present technology with internal polymer layers shown in hidden detail.

[0094] FIG. 5 is a schematic view of a portion of a knitted conductive fabric.

[0095] FIG. 6 is a schematic view of a portion of a woven conductive fabric.

[0096] FIG. 7 is a schematic view of a portion of a braided conductive fabric.

[0097] FIG. 8 is a schematic cross-sectional view of one form of an air conduit of the present technology.

[0098] FIG. 9 is a schematic cross-sectional view of another form of an air conduit of the present technology. DETAILED DESCRIPTION

[0099] Before the present technology is described in detail, it is to be understood that the technology can not necessarily be limited to the specific examples described herein. Also, it is to be understood that the terminology used herein is for the purpose of describing particular instances only, and is not intended to limit the scope of the present disclosure.

[0100] The following description provides details of various examples that can share one or more common characteristics and / or features. It will be understood that one or more features of any one example can be combined 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.

[0101] 4.1 Therapy

[0102] In one form, the present technology includes a method for treating a respiratory disorder, the method including applying positive pressure to an entrance of the airways of a patient 1000.

[0103] In certain examples of the present technology, a supply of air at positive pressure is provided to the nasal passages of a patient via one or both nares.

[0104] In certain examples of the present technology, mouth breathing is restricted, constrained or prevented.

[0105] 4.2 Respiratory therapy system

[0106] In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0107] 4.3 Patient Interface

[0108] According to one aspect of this technology, such as FIG. 3A The non-invasive patient interface 3000 shown includes the following functional aspects: a seal-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connecting to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the airway inlet of the patient 1000. The sealed patient interface 3000 is therefore suitable for the delivery of positive pressure therapy.

[0109] like FIG. 3B As shown, the non-invasive patient interface 3000 according to another aspect of the present technology includes the following functional aspects: a sealing forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, and a connection for connecting to an air circuit (e.g., FIG. 1A through FIG. 1C The air circuit 4170 shown is a connection port 3600 in one form. The air chamber 3200 may be formed by one or more modular components (e.g., a gasket module 3150 together with a sealing forming structure 3100), in which case it or they may be replaced by different components (e.g., components of different sizes).

[0110] In some forms of this technology, the positioning and stabilization structure 3300 includes one or more head tubes 3350 that deliver pressurized air from the RPT device to the patient's airway, for example, through an inflation chamber 3200 and a sealing formation structure 3100. FIG. 3B In the illustrated form of this technology, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the inflation chamber 3200. The tubes 3350 are configured to position and stabilize the sealing formation 3100 of the patient interface 3000 at an appropriate portion of the patient's face (e.g., nose and / or mouth) during use. This allows the conduit of the air circuit 4170, which provides pressurized airflow, to connect to the connection port 3600 of the patient interface at a location other than in front of the patient's face (e.g., at the top of the patient's head).

[0111] existFIG. 3B In the form of the technology shown, the positioning and stabilising structure 3300 comprises two tubes 3350, each of which is positioned, in use, on a different side of the patient's head and extends over the respective ear (over the otobasion superior on the patient's head) through the respective cheek region to a elbow tube 3610 at the top of the patient's 1000 head. This form of the technology can be advantageous because if the patient sleeps with their head on one side and one of the tubes 3350 is compressed to block or partially block the flow of gas along that 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 comprise a different number of tubes, for example one tube, or two or more tubes. The tubes 3350 can comprise a tab 3320 for connection of the strap 3310.

[0112] 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 a 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, in order to help hold the seal-forming structure 3100 in a sealing position.

[0113] In one form, the tube 3350 can be at least partially extendable so 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 so that the seal-forming structure substantially remains in the middle.

[0114] In FIG. 3B In the form of the technology shown, 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 and can be disconnected, in use, 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 is fluidly connectable to a respective one of the tubes 3350. Additionally, the T-connector can have a third arm or opening which provides the connection port 3600 for fluid connection, in use, to the air circuit 4170. This opening can be an inlet for receiving a flow of pressurised air.

[0115] Each tube 3350 can be configured to receive a flow of air from a connection port 3600 on the top of the patient's head and to deliver the flow of air to the seal-forming structure 3100 at the entrance of the patient's airways. 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 in use cover the maxilla region of the patient's head. Another portion of each tube 3350 can cover an area of the patient's head superior to the patient's otobasion superior. Each tube 3350 can also be located over either or both of the patient's sphenoid and / or temporal bones and the patient's frontal and parietal bones. The elbow 3610 can in use be located on the patient's parietal bone, frontal bone and / or the junction between them (e.g. the coronal suture). FIG. 3B 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 in use cover the maxilla region of the patient's head. Another portion of each tube 3350 can cover an area of the patient's head superior to the patient's otobasion superior. Each tube 3350 can also be located over either or both of the patient's sphenoid and / or temporal bones and the patient's frontal and parietal bones. The elbow 3610 can in use be located on the patient's parietal bone, frontal bone and / or the junction between them (e.g. the coronal suture).

[0116] Cannulae forming part of the positioning and stabilising structure 3300, such as headgear straps, can provide a force that assists in the positioning and stabilising of the patient interface 3000. In some forms, the cannulae can provide a force directed towards the patient's head when the cannulae are filled with pressurised air. This force can assist in gripping the patient's head. The force can be caused by the expansion of the cannulae during normal use. In some forms, the force can provide a cushioning effect for the patient's head. The cannulae can be designed to limit expansion to prevent excessive clamping of the patient's head.

[0117] In some examples of the technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tubes 3350 can include one or more extendable tube sections, for example formed from an extendable concertina 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 extendable concertina structure. FIG. 3B The patient interface 3000 illustrated in Figure 6 includes tubes 3350, the upper portions of which include extendable tube sections, each in the form of an extendable concertina structure 3362.

[0118] In some forms of the technology, one or both of the tubes 3350 can be formed in whole or in part from an air conduit that is capable of conducting electricity, as described further below.

[0119] 4.4 RPT devices

[0120] An RPT device 4000 according to one aspect of the technology comprises mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms, such as all or part of any 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 in order to treat one or more of the respiratory conditions described elsewhere in this document.

[0121] 4.5 Air conduit

[0122] Referring next FIG. 4 In one form of the technology, a tube such as the air conduit 8000, which can for example form part of the air circuit 4170 and / or the positioning and stabilising structure 3300 for a patient interface 3000, is electrically conductive (at power voltages and currents and / or at signal voltages and currents) along at least a portion of its length. For example, the air conduit 8000 can wholly or partially form the tube 3350 of the positioning and stabilising structure 3300 of the patient interface 3000 as shown in FIG. 3B or the tube 3350 of the air circuit 4170 as shown in FIG. 1C .

[0123] According to one form of the technology, the air conduit 8000 comprises a fabric outer layer 8010 and at least one inner layer 8020 comprising a polymer layer 8030. In examples, the innermost layer 8022 is a substantially gas impermeable polymer layer 8030.

[0124] In examples, the fabric outer layer 8010 is an electrically conductive (e.g. electrically conductive) fabric. In other examples, at least one of the inner layers 8020 comprises an electrically conductive coating 8050 (see FIG. 8 ). In some forms of the technology, the outer fabric layer is an electrically conductive fabric 8040 and one of the inner layers 8020 comprises an electrically conductive coating 8050.

[0125] In one form of the technology, the electrically conductive coating 8050 and / or the electrically conductive fabric 8040 is configured to heat the air conduit 8000 or at least the innermost layer 8022 when conducting electrical current. Additionally or alternatively, the electrically conductive coating 8050 and / or the electrically conductive fabric 8040 can be configured to transfer power between components of a system for treating a respiratory disorder (e.g. from an RPT device to an actuator or valve) and / or to transfer electrical signals between these components, as described further below.

[0126] The fabric outer layer 8010 can be permanently bonded to the polymer layer 8030 or it can take the form of a removable covering.

[0127] The removable cover can also be composed of a fabric outer layer 8010 with a conductive coating 8050. In other examples, the conduit can include a removable cover that includes a fabric outer layer and a conductive coating 8050 and an inner polymer layer 8330 or an inner fabric layer.

[0128] 4.5.1 Conductive Fabric

[0129] In an example, the conductive wires or fibers can form part of a fabric that forms part of the air conduit 8000.

[0130] The fabric can be formed by knitting (including circular knitting or 3D knitting), weaving, braiding, or any similar process.

[0131] For example, as shown in FIG. 5 the fabric outer layer 8010 can be a conductive fabric 8040, such as a knitted fabric 8060. Highly deformable conductive fibers 8070 (such as wires composed of a mix of conductive and non-conductive fibers with mechanical properties suitable for a knitting process) can be knitted into the fabric 8060 such that they form part of the structure of the fabric 8060. In another example (not shown), the conductive fibers can be interwoven into the knitted fabric without forming part of the fabric structure (such as without forming part of the courses of the fabric 8060). This can be particularly suitable if the conductive fibers 8070 have a relatively low flexibility (such as pure metal monofilament fibers from steel, titanium, aluminum, silver, gold, or copper with a fine diameter of 1 to 80 pm) as their mechanical properties can not allow for their use in a knitting process.

[0132] The conductive fibers 8070 can include conductive polymers, such as one or more of polyacetylene, polypyrrole, and polyaniline. The conductive fibers 8070 can also include suitable metals and / or non-conductive materials coated with a suitable conductive coating (such as carbon nanotubes or metal particles).

[0133] Referring next to FIG. 6 in one example, the fabric layer 8010 can be formed of a woven fabric that includes warp threads 8080 and weft threads 8090. At least one of the warp threads 8080 and the weft threads 8090 can include conductive fibers 8070.

[0134] Referring next to FIG. 7 in another example, the fabric layer 8010 can be braided. At least one conductive fiber 8070 can be incorporated into the fabric layer 8010.

[0135] In other examples of the technology, the conductive fabric fibers 8070 can be provided to a surface (e.g., an inner surface) of the fabric layer 8010. In one example, the conductive portions, e.g., conductive fibers 8070, can be applied to the surface of the fabric layer 8010 by an embroidery process. In another example, the conductive fibers 8070 can be attached to the surface of the fabric layer 8010 by a tailored fiber placement (TFP) process, in which a roving material including conductive fibers is stitched to the surface of the fabric.

[0136] 4.5.2 Polymer layer

[0137] Referring next FIG. 8 In examples, the conductive coating 8050 (or multiple such coatings) can be provided to an outer surface of the polymer layer 8030 by a conductive ink, paste, liquid metal gel, or the like. In one example, screen printing is used to deposit the conductive material. In other examples, the conductive coating 8050 can include metal and / or carbon particles.

[0138] The conductive coating 8050 preferably defines a conductive trace (or multiple such traces) on the surface of the polymer layer 8030, rather than coating the entire surface of the polymer layer 8030.

[0139] 4.5.3 Intermediate layer

[0140] Referring next FIG. 9 In examples, the air conduit 8000 can include one or more intermediate inner layers 8100 inside (e.g., radially inside) the outer fabric layer 8010 but outside the polymer layer 8030. At least one of the intermediate layers 8100 is electrically conductive. In one form of the technology, the intermediate layer includes a flexible printed circuit board 8110 that includes at least one conductive trace. In other forms of the technology, the intermediate layer can include alternative conductive elements, such as one or more wires and / or a sheet of conductive material.

[0141] 4.5.4 Spiral trace

[0142] In examples configured to heat the air conduit 8000, at least one conductive portion of the air conduit 8000, e.g., the conductive fabric fibers 8070 or the conductive surface coating 8050, can be configured to follow a generally spiral path around the air conduit 8000. In other examples, the conductive portion can be oriented substantially longitudinally along the length of the conduit.

[0143] 4.5.5 Electrical / electronic components

[0144] Referring back FIG. 4The air conduit 8000 can include suitable electrical components 8120, such as a flow sensor, a humidity sensor, and / or a temperature sensor (e.g. a thermocouple, a platinum resistance thermometer or a thermistor, etc.). Further details of such components are disclosed in US Patent Application Publication 2008 / 0105257 Al, the contents of which are incorporated herein by reference. Such electrical components can be in electrical communication with a controller (e.g. of the RPT device and / or humidifier) via the air conduit 8000, e.g. via one or more electrically conductive fibres 8070.

[0145] In an example, the air conduit 8000 can also include one or more antennas, such as a Bluetooth antenna, a Wi-Fi antenna, and / or an RFID antenna. Such antennas can also be in electrical communication with a controller (e.g. of the RPT device and / or humidifier) via the air conduit 8000, e.g. via one or more electrically conductive fibres 8070.

[0146] 4.6 Air circuit

[0147] An air circuit 4170 according to one aspect of the present technology is a conduit or tube (e.g. an electrically conductive tube as described above) constructed and arranged to, in use, allow a flow of air to travel between two components such as the RPT device 4000 and the patient interface 3000.

[0148] In particular, the air circuit 4170 can be in fluid connection with the outlet of the pneumatic block of the RPT device and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there can be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0149] 4.6.1 Supplementary gas delivery

[0150] In one form of the present technology, supplementary gas (e.g. oxygen) is delivered to one or more points in the pneumatic path, such as upstream of the pneumatic block, to the air circuit 4170, and / or to the patient interface 3000.

[0151] 4.7 Humidifier

[0152] 4.7.1 Humidifier overview

[0153] In one form of the present technology, a humidifier 5000 (e.g. as shown in FIG. 1A Fig. 6) is provided to alter the absolute humidity of the air or gas delivered to a patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the flow of air and to increase the temperature of the flow of air (relative to the ambient air) prior to delivery to the patient’s airways.

[0154] 4.8 Glossary

[0155] For the purposes of the present technical disclosure, in certain forms of the technology one or more of the following definitions can apply. In other forms of the technology alternative definitions can apply.

[0156] 4.8.1 General

[0157] Air: In certain forms of the technology, air can be taken to mean atmospheric air, and in other forms of the technology air can be taken to mean some other combination of breathable gases, such as oxygen enriched air.

[0158] Ambient: In certain forms of the technology, the term ambient will be taken to mean (i) external to the therapy system or patient, and (ii) directly surrounding the therapy system or patient.

[0159] For example, ambient humidity with respect to a humidifier can be the humidity of the air immediately surrounding the humidifier, such as the humidity in the room in which the patient is sleeping. Such ambient humidity can be different to the humidity outside the room in which the patient is sleeping.

[0160] In another example, ambient pressure can be the pressure immediately surrounding or external to the body.

[0161] In certain forms, ambient (e.g. acoustic) noise can be taken to be the background noise level in the room in which the patient is located, rather than, for example, noise generated by the RPT device or emanating from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0162] Auto-titration positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between minimum and maximum limits, for example between breaths, in dependence upon the presence or absence of indications of SDB events.

[0163] Continuous positive airway pressure (CPAP) therapy: Breathing pressure therapy in which the treatment pressure is maintained substantially constant throughout the patient’s respiratory cycle. In some forms the pressure at the entrance to the airways will be slightly higher during exhalation, and slightly lower during inhalation. In some forms the pressure will vary between different respiratory cycles of the patient, for example being increased in response to detection of indications of partial airway obstruction, and being decreased in the absence of indications of partial airway obstruction.

[0164] Flow rate: The amount (or mass) of air delivered per unit of time. Flow rate can refer to the instantaneous amount. In some cases reference to flow rate will be reference to a scalar quantity, i.e. an amount with only a magnitude. In other cases reference to flow rate will be reference to a vector quantity, i.e. an amount with both a magnitude and a direction. Flow rate can be denoted by the symbol Q. “Flow rate” is sometimes simply abbreviated to “flow” or “airflow”.

[0165] In the example of a patient breathing, the flow rate can be nominally positive for the inspiration portion of the patient's breathing cycle and thus negative for the expiration portion of the patient's breathing cycle. The device flow rate Qd is the flow rate of air leaving the RPT device. The total flow rate Qt is the flow rate of air and any supplemental gases to the patient interface via the air circuit. The vent flow rate Qv is the flow rate of air exiting a vent to allow flushing of exhaled gases. The leak flow rate Ql is the flow rate of leaks from the patient interface system or elsewhere. The respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0166] Flow therapy: Respiratory therapy including the delivery of a flow of air to the entrance of the airways at a controlled flow rate known as the treatment flow rate, which is generally positive throughout the patient's respiratory cycle.

[0167] Humidifier: The term humidifier will be taken to mean a humidification apparatus constructed and arranged or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H20) vapour to a flow of air to improve a patient's medical respiratory condition.

[0168] Leak: The word leak will be taken to mean an unintended flow of air. In one example, a leak can occur due to an imperfect seal between a mask and the patient's face. In another example, a leak can occur in a swivel elbow leading to ambient.

[0169] Conducted noise (acoustics): Conducted noise in this document refers to noise transmitted to the patient through the pneumatic path such as the air circuit and patient interface and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at one end of the air circuit.

[0170] Radiated noise (acoustics): Radiated noise in this document refers to noise transmitted to the patient by the surrounding ambient air. In one form, radiated noise can be quantified according to ISO 3744 by measuring the sound power / sound pressure level of the object in question.

[0171] Ventilation noise (acoustics): Ventilation noise in this document refers to noise generated by the flow of air through any vent such as a vent hole of a patient interface.

[0172] Oxygen enriched air: Air with an oxygen concentration greater than atmospheric (21%), for example at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "Oxygen enriched air" is sometimes referred to simply as "oxygen".

[0173] Medical oxygen: Medical oxygen is defined as oxygen enriched air with an oxygen concentration of 80% or more.

[0174] Patient: A human, whether or not they have a respiratory condition.

[0175] Pressure: Force per unit area. Pressure can be expressed in a number of units, including cmH20, g-f / cm 2 and hectopascals. 1 cmH2O is equal to 1 g-f / cm 2 and approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m 2 = 1 millibar ~ 0.001 atm). In this specification, pressure is given in units of cmH20, unless otherwise stated.

[0176] Pressure in the patient interface is given the symbol Pm, while the therapy pressure, which represents the target value achieved by the interface pressure Pm at the current instant, is given the symbol Pt.

[0177] Respiratory pressure therapy: The application of a supply of air at a usually positive therapeutic pressure relative to atmosphere to the entrance of the airways.

[0178] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0179] 4.9 Other Notes

[0180] A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent and Trademark Office, patent files or records, but otherwise reserves all copyright rights whatsoever.

[0181] Unless otherwise stated in the context of a numerical range, it is to be understood that every intermediate value of the upper limit, to the lower limit of that range and to one-tenth of the lower limit unit, and any other stated or intervening value in that range is encompassed within the technology. The upper and lower limits of these intermediate ranges can be independently included in the intermediate ranges and are also encompassed within the technology, subject to any explicitly excluded limits in the range. Where the range includes one or both of the limits, ranges excluding one or both of the included limits are also included in the technology.

[0182] Further, where a value or values are stated herein as being implemented as part of the technology, it is to be understood that such values can be approximate, unless otherwise stated, and such values can be used to any appropriate significant figures that practical implementation of the technology can allow or require.

[0183] Further, as used herein, "about," "substantially," "approximately," or any like term means + / - 5 to 10% of the stated value.

[0184] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.

[0185] When a particular material is identified as being used to construct a component, obvious alternative materials of similar properties can be used as a substitute. Moreover, unless specified to the contrary, any and all components described herein are understood to be capable of being manufactured and thus can be manufactured together or separately.

[0186] It must be noted that, as used herein and in the appended claims, the singular form "a", "an", and "the" include plural referents unless the context clearly dictates otherwise.

[0187] All publications mentioned herein are incorporated by reference in their entirety to disclose and describe the methods and / or materials in connection with which the publications are cited. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present technology is not entitled to antedate such publications. Further, the dates of publication provided can be different from the actual publication dates, which can need to be independently confirmed.

[0188] The terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, referring to the possibility that there are other elements, components, or steps not listed.

[0189] The subject matter headings are included for ease of reference only and are not to be construed as limiting the subject matter described in the respective sections. Subject matter headings are not to be considered in construing the meaning of any limitation in a claim.

[0190] While the technology herein has been described with reference to particular examples, it should be understood that these examples are merely illustrative of the principles and applications of the technology. In some instances, terms and notation can imply specific details that are not required in practice of the technology. For example, while the terms "first" and "second" can be used, unless otherwise noted, they are not intended to imply any order, but can be used to distinguish different elements. Moreover, while process steps in a method can be described or illustrated in an order, such order is not necessarily required. Those skilled in the art will recognize that such order can be modified and / or that some aspects can be performed concurrently or even synchronously.

[0191] Thus, it is to be understood that modifications can be made to the illustrative examples described herein without departing from the spirit and scope of the technology.

[0192] 4.10 List of reference signs

[0193]

Claims

1. An air conduit for a system for treating a respiratory disorder, the air conduit comprising an outer layer of fabric and at least one inner layer comprising a polymer layer, wherein the outer fabric layer is an electrically conductive fabric and / or at least one of the inner layers comprises an electrically conductive coating.

2. The air conduit of claim 1, wherein the fabric layer comprises at least one electrically conductive fiber.

3. The air conduit of claim 1, wherein the fabric layer is formed by circular knitting or weaving, and at least one of the weft yarns is an electrically conductive fiber.

4. The air conduit of claim 1, wherein the fabric layer is formed by conventional knitting or circular knitting, and at least one of the warp yarns is an electrically conductive fiber.

5. The air conduit of claim 1, wherein the fabric is formed by a braiding process, and at least one of the yarns is an electrically conductive fiber.

6. The air conduit of any one of claims 1 to 5, wherein the polymer layer comprises at least one trace formed from an electrically conductive ink, paste or gel or liquid metal.

7. The air conduit of any one of claims 1 to 6, wherein at least one of the inner layers comprises an electrically conductive element.

8. The air conduit of claim 7, wherein the electrically conductive element comprises a flexible printed circuit board (PCB), one or more wires and / or a sheet of electrically conductive material.

9. The air conduit of any one of claims 1 to 8, wherein at least one of the inner layers and / or electrically conductive fabric is configured to conduct an electrical signal.

10. The air conduit of any one of claims 1 to 9, wherein at least one of the inner layers and / or electrically conductive fabric is configured to conduct electrical power.

11. The air conduit of any one of claims 1 to 10, wherein at least one of the inner layers and / or electrically conductive fabric is configured to heat the air conduit when conducting an electrical current.

12. The air conduit of any one of claims 1 to 11, wherein the air conduit comprises at least one sensor and / or at least one antenna, wherein the at least one sensor and / or at least one antenna is electrically connected to the electrically conductive fabric and / or electrically conductive coating.

13. The air conduit of any one of claims 1 to 12, wherein the air conduit forms part of an air circuit.

14. The air conduit of any one of claims 1 to 13, wherein the air conduit forms part of a headgear for a patient interface.

15. An air conduit for a system for treating a respiratory disorder, the air conduit comprising an outer layer of fabric, at least one inner layer comprising a polymer layer and at least one electrically conductive intermediate layer.

16. The air conduit of claim 15, wherein the intermediate layer comprises a flexible printed circuit board (PCB), one or more wires and / or a sheet of electrically conductive material.

17. The air conduit of any one of claims 15 or 16, wherein the electrically conductive intermediate layer is configured to conduct an electrical signal.

18. The air conduit of any one of claims 15 or 16, wherein the electrically conductive intermediate layer is configured to conduct electrical power.

19. The air conduit of claim 18, wherein the electrically conductive intermediate layer is configured to heat the air conduit when conducting electrical current.

20. The air conduit of any one of claims 15 to 19, wherein the air conduit comprises at least one sensor and / or at least one antenna, wherein the at least one sensor and / or at least one antenna is electrically connected to the electrically conductive intermediate layer.

21. The air conduit of any one of claims 15 to 20, wherein the air conduit forms part of an air circuit.

22. The air conduit of any one of claims 15 to 20, wherein the air conduit forms part of a headgear for a patient interface.

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