An air conduit for a system for treating respiratory disorders

Abstract

The utility model relates to an air conduit for a system for treating respiratory disorders. An air conduit for a system for treating respiratory disorders comprises an outer fabric layer and at least one inner layer comprising a polymer layer. The outer fabric layer is an electrically conductive fabric and / or at least one of the inner layers comprises an electrically conductive coating. The conduit can form part of an air circuit and / or a headgear of a patient interface. An air conduit with an electrically conductive intermediate layer is also disclosed.

Description

Technical Field

[0001] This technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses. Background Technology

[0002] Human respiratory system and its disorders

[0003] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0004] The airways consist of a series of branching tubes that become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into the venous blood, while carbon dioxide moves in the opposite direction. The trachea divides into the left and right main bronchioles, which eventually branch into the terminal bronchioles. The bronchi form the conduction airways and 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 lungs is where gas exchange occurs and is called the respiratory region. See John B. West's *Physiology of Respiratory Systems*, Lippincott Williams & Wilkins, 2012. Respiratory Physiology 9th edition of "The 9th Edition ...

[0005] A range of breathing disorders exist. Some disorders may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.

[0006] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity-related poor ventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0007] therapy

[0008] Various respiratory therapies, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), have been used to treat one or more of the above-mentioned respiratory disorders.

[0009] Respiratory pressure therapy

[0010] Respiratory pressure therapy is the application of supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy such as canister ventilators or thoracic ventilators).

[0011] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). Its mechanism of action is that CPAP acts as a pneumatic splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to the therapy if they find one or more of the following to be true: uncomfortable, difficult to use, expensive, or unsightly.

[0012] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the breathing work. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as orthostatic hypoxia (OHS), chronic respiratory disease (COPD), non-invasive disease (NMD), and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0013] Noninvasive ventilation (IV) provides ventilatory support for patients who are no longer able to breathe effectively on their own and can be delivered using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0014] Flow therapy

[0015] Not all respiratory therapies are designed to deliver a prescribed therapeutic pressure. Some respiratory therapies are designed to deliver a prescribed volume of air by delivering an inspiratory flow rate profile (possibly superimposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and the respiratory therapy may supplement only the patient's own spontaneous breathing with a regulated or enriched flow of gas. In one instance, high-flow therapy (HFT) can be a continuous, heated, humidified flow of air to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that remains approximately constant throughout the respiratory cycle. This therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that the high-flow-rate air at the airway inlet improves ventilation efficiency by flushing or removing exhaled CO2 from the patient's anatomical dead zone. Therefore, HFT is sometimes referred to as deadspace therapy (DST). Other benefits may include increased warmth and humidity (which may be beneficial in secretion management) and the possibility of appropriately increasing airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate can follow a curve that varies throughout the respiratory cycle.

[0016] Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. Doctors can deliver a continuous stream of oxygen-enriched air to the patient's airway at a specified oxygen concentration (21% to 100% of the oxygen fraction in ambient air) and a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).

[0017] Replenish oxygen

[0018] For some patients, oxygen therapy can be combined with respiratory pressure therapy (RPT) or high-pressure airflow (HFT) by adding supplemental oxygen to the pressurized airflow. When oxygen is added to respiratory pressure therapy, this is called RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is called HFT with supplemental oxygen.

[0019] Respiratory therapy system

[0020] These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.

[0021] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0022] Patient Interface

[0023] Patient interfaces can be used to connect breathing equipment to their wearer, for example, by providing an airflow into the airway inlet. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy to be applied, the patient interface can, for example, form a seal with an area of ​​the patient's face to facilitate the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of about 10 cmH2O relative to ambient pressure). For other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply to the airway at a positive pressure of about 10 cmH2O. For flow-based therapies such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0024] Respiratory Pressure Therapy (RPT) device

[0025] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned therapies, such as by operating the device to generate an airflow for delivery to an airway interface. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow-based therapies such as HFT). Therefore, RPT devices can also be used as flow-based therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0026] air circuit

[0027] An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, there may be separate branches of the air circuit for inhalation and exhalation. In other cases, a single-branch air circuit is used for both inhalation and exhalation.

[0028] In many instances of the prior art, an air circuit may include one or more heating elements configured to heat the air in the air circuit, for example, to maintain or raise the temperature of the air. The heating elements may be in the form of a heating wire loop (typically copper wire) and may include one or more transducers, such as temperature sensors. In one form, the heating wire loop may be helically wound around the axis of the air circuit. The heating elements may be in communication with a controller, such as a central controller of an RPT device. An example of an air circuit including a heating wire loop is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0029] While such heating elements can effectively prevent condensation (so-called "rain") within the air circuit, they can increase the weight of the air circuit and potentially increase the complexity of manufacturing it.

[0030] humidifier

[0031] Delivering an unhumidified airflow can lead to airway dryness. Using a humidifier with an RPT device and patient interface to produce humidified gas minimizes dryness of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, warm air applied to the area inside and around the patient interface on the face is generally more comfortable than cold air.

[0032] Screening, diagnosis and monitoring systems

[0033] Polysomnography (PSG) is a routine system used for diagnosing and monitoring cardiopulmonary disorders, and it typically involves a clinician in its application. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), and electromyography (EMG). For sleep-disordered breathing, PSG involves two nights of observation in a clinic: one night for pure diagnosis, and the second night for titration of treatment parameters by a clinician. Therefore, PSG is both expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.

[0034] Screening and diagnosis typically describe the identification of a condition from its signs and symptoms. Screening usually provides a true / false result indicating whether a patient's SDB is severe enough to require further investigation, while diagnosis can produce clinically actionable information. Screening and diagnosis tend to be one-off processes, while monitoring condition progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.

[0035] Clinicians may be able to adequately screen, diagnose, or monitor patients based on visually observed PSG signals. However, there are situations where clinicians may not be available or may not be able to afford them. Different clinicians may have different opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. Utility Model Content

[0036] This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0037] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0038] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0039] One aspect of certain forms of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0040] One form of this technology includes a positioning and stabilizing structure configured to provide force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes at least one band.

[0041] One form of this technology includes a patient interface comprising an inflation chamber, a sealing formation structure, and a positioning and stabilizing structure.

[0042] One form of this technology includes a patient interface comprising an inflatable chamber pressurizable to a therapeutic pressure at least 4 cmH2O above ambient air pressure. The inflatable chamber includes at least one inflatable chamber inlet port, sized and configured to receive an airflow at the therapeutic pressure for patient breathing. The patient interface also includes a sealing structure configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet. The sealing structure has an opening therein, such that the airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils. The sealing structure is configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use. The patient interface also includes positioning and stabilizing structures to provide forces that hold the sealing structure in a therapeutically effective position on the patient's head.

[0043] Another aspect of this technology is a series of modular elements that can be interconnected to form different styles of patient interfaces.

[0044] In one form, each modular element has at least two versions or styles. These versions or styles can be used interchangeably to form different modular components.

[0045] One form of the technology includes a tube comprising an outer fabric layer and at least one inner layer comprising a polymer layer, wherein the outer fabric layer is a conductive fabric and / or at least one of the inner layers comprises a conductive coating.

[0046] One form of this technology includes an air conduit for a system for treating respiratory disorders, the air conduit comprising an outer fabric layer and at least one inner layer comprising a polymer layer, wherein the outer fabric layer is a conductive fabric and / or at least one of the inner layers comprises a conductive coating.

[0047] In the example:

[0048] The fabric layer includes at least one conductive fiber;

[0049] The fabric layer is formed by cylindrical knitting or weaving, and at least one of the weft yarns is a conductive fiber;

[0050] The fabric layer is formed by conventional knitting or cylindrical knitting, and at least one of the warp yarns is a conductive fiber;

[0051] The fabric is formed by a weaving process, and at least one of the yarns is a conductive fiber;

[0052] The polymer layer includes at least one trace formed of conductive ink, paste, gel, or liquid metal;

[0053] The air duct includes another inner layer between the polymer layer and the fabric layer;

[0054] The other inner layer includes conductive elements;

[0055] Conductive components include flexible printed circuit boards (PCBs), one or more wires, or sheets of conductive material;

[0056] At least one of the inner layer and / or conductive fabric is configured to conduct electrical signals;

[0057] At least one of the inner layer and / or conductive fabric is configured to conduct electricity;

[0058] At least one of the inner layer and / or conductive fabric is configured to heat the air duct when conducting current;

[0059] The air duct includes 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 conductive fabric and / or conductive coating;

[0060] The air duct forms part of the air circuit; and / or

[0061] The air duct forms part of the headgear used for the patient interface.

[0062] Another form of this technology includes an air conduit for a system for treating respiratory disorders, the air conduit comprising a fabric outer layer, at least one inner layer comprising a polymer layer, and at least one conductive intermediate layer.

[0063] Preferably:

[0064] The intermediate layer includes a flexible printed circuit board (PCB), one or more conductors, and / or a sheet of conductive material;

[0065] The conductive intermediate layer is configured to conduct electrical signals;

[0066] The conductive intermediate layer is configured to conduct electricity;

[0067] The conductive interlayer is configured to heat the air duct when conducting current;

[0068] The air duct includes 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 conductive intermediate layer;

[0069] The air duct forms part of the air circuit; and / or

[0070] The air duct forms part of the headgear used for the patient interface.

[0071] Another aspect of this technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0072] One aspect of this technology is a method for manufacturing equipment.

[0073] Another aspect of this technology is a method for assembling a modular system, including selecting positioning and stabilizing structures and connecting the positioning and stabilizing structures to a first liner or a second liner.

[0074] One aspect of certain forms of this technology is an easy-to-use medical device, for example, easy for a person without medical training, a person with limited dexterity or vision, or a person with limited experience in using this type of medical device.

[0075] One aspect of this technology is a portable RPT device that can be carried by a person, for example, in a person's home.

[0076] One aspect of this technology is a patient interface that can be cleaned at the patient's home, for example, in soapy water, without requiring specialized cleaning equipment. Another aspect of this technology is a humidifier water tank that can be cleaned at the patient's home, for example, in soapy water, without requiring specialized cleaning equipment.

[0077] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors (such as processors in dedicated computers, respiratory monitors, and / or respiratory therapy devices). Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0078] Of course, parts of these aspects can form sub-aspects of this technology. Furthermore, sub-aspects and / or aspects of each aspect can be combined in various ways and also constitute additional aspects or sub-aspects of this technology.

[0079] Other features of the technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description

[0080] The technology is illustrated by way of example and not limitation in the accompanying drawings, wherein similar reference numerals refer to similar elements, including:

[0081] Respiratory therapy system

[0082] Figure 1AA system including a patient 1000 is shown, who wears a patient interface 3000 in the form of a nose pillow and receives a positive pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient is sleeping in a supine position.

[0083] Figure 1B A system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0084] Figure 1C A system including a patient 1000 wearing a full-face mask-like patient interface 3000 receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a side-lying position.

[0085] Respiratory system and facial anatomy

[0086] Figure 2 A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0087] Patient Interface

[0088] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0089] Figure 3B A patient interface with a catheter tip cap, according to this technology, is shown.

[0090] air duct

[0091] Figure 4 This is a schematic side view of a portion of the air duct of this technology, with the inner polymer layer shown in hidden details.

[0092] Figure 5 This is a schematic diagram of a portion of a knitted conductive fabric.

[0093] Figure 6 This is a schematic diagram of a portion of a woven conductive fabric.

[0094] Figure 7 This is a schematic diagram of a portion of a woven conductive fabric.

[0095] Figure 8 This is a schematic cross-sectional view of one form of air duct in this technology.

[0096] Figure 9 This is a schematic cross-sectional view of another form of air duct in this technology. Detailed Implementation

[0097] Before describing this technology in more detail, it should be understood that the technology is not limited to the specific instances that may vary as described herein. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific instances discussed herein and is not intended to be limiting.

[0098] The following description is provided for various instances that may share one or more common characteristics and / or features. It should be understood that one or more features of any instance may be combined with one or more features of another instance or other instances. Furthermore, any single feature or combination of features in any instance may constitute another instance.

[0099] therapy

[0100] In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0101] In some instances of this technology, positive pressure air is supplied to the patient's nasal passages via one or both nostrils.

[0102] In some instances of this technology, mouth breathing is restricted, constrained, or prevented.

[0103] Respiratory therapy system

[0104] 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.

[0105] Patient Interface

[0106] According to one aspect of this technology, such as Figure 3AThe 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.

[0107] like Figure 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., Figures 1A to 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).

[0108] 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. Figure 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).

[0109] exist Figure 3BIn the illustrated form of this technology, the positioning and stabilizing structure 3300 includes two tubes 3350, each positioned on a different side of the patient's head during use, and extending above the corresponding ear (above an auricular base point above the patient's head) through the corresponding cheek area to a curved tube 3610 at the top of the patient's head. This form of the technology may be advantageous because if the patient is sleeping with their head turned to the 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 pressurized gas to the patient. In other instances of this technology, the patient interface 3000 may include a different number of tubes, such as one tube, or two or more tubes. The tubes 3350 may include flaps 3320 for connecting to the carrying strap 3310.

[0110] In one example where the patient interface has a tube 3350, the single tube 3350 is positioned on one side of the patient's head during use (e.g., across a cheek area), and the band forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head during use (e.g., across another area) to help secure the patient interface 3000 to the patient's head. For example, the tube 3350 and the band may each be under tension during use to help hold the sealing structure 3100 in a sealed position.

[0111] In one embodiment, the tube 3350 may be at least partially extendable, such that the tube 3350 and the band can be adjusted to substantially equal lengths when worn by a patient. This allows for substantially symmetrical adjustment between the tube 3350 and the band, such that the sealing structure remains substantially centered.

[0112] exist Figure 3B In the illustrated embodiment, two tubes 3350 are fluidly connected to each other at their upper ends and fluidly connected to a connection port 3600. In some instances, the two tubes 3350 are formed integrally, while in other instances, the tubes 3350 are formed separately but connected in use and can be disconnected, for example, for cleaning or storage. When using separate tubes, they can be indirectly connected together, for example, each can be connected to a T-connector. The T-connector may have two arms / branches, each of which is fluidly connected to a corresponding one of the tubes 3350. Additionally, the T-connector may have a third arm or opening that provides a connection port 3600 for fluid connection to an air circuit 4170 in use. This opening may be an inlet for receiving a pressurized airflow.

[0113] Each tube 3350 can be configured to receive an airflow from a connection port 3600 on the top of the patient's head and deliver that airflow to a sealing structure 3100 at the patient's airway inlet. Figure 3B In the example shown, each tube 3350 is positioned in use along a path extending from the inflation chamber 3200 through the patient's cheek area and above the patient's ear to the bend 3610. For example, the portion of each tube 3350 near the inflation chamber 3200 may cover the maxillary region of the patient's head in use. Another portion of each tube 3350 may cover the area of ​​the patient's head above the supraacus base. Each tube 3350 may also be positioned on either or both of the patient's sphenoid and / or temporal bones, and the patient's frontal and parietal bones. The bend 3610 may be positioned in use on the patient's parietal bone, frontal bone, and / or at the junction between them (e.g., the coronal suture).

[0114] The catheter, such as a headband, which forms part of the positioning and stabilizing structure 3300, can provide forces that aid in positioning and stabilization. In some forms, when the catheter is filled with pressurized air, it can provide a force directed towards the patient's head. This force can help grip the patient's head. This force can be caused by the expansion of the catheter during normal use. In some forms, this force can provide cushioning for the patient's head. The catheter can be designed to limit expansion to prevent excessive clamping of the patient's head.

[0115] In some embodiments of this technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tube 3350 may include one or more extendable tube segments, for example, formed by an extendable accordion-like structure. In some forms, the patient interface 3000 may include a positioning and stabilizing structure 3300 comprising at least one gas delivery tube having a tube wall having an extendable accordion-like structure. Figure 3B The patient interface 3000 shown includes a tube 3350, the upper part of which includes extendable tube sections, each tube section being in the form of an extendable accordion structure 3362.

[0116] In some forms of this technology, one or both of the tubes 3350 may be formed wholly or partially from an air conduit capable of conducting electricity, as further described below.

[0117] RPT device

[0118] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to perform one or more algorithms, all or part of any of the methods described herein. The RPT device 4000 can be configured to generate an airflow for delivery to a patient's airway to treat one or more respiratory conditions described elsewhere in this document.

[0119] air duct

[0120] Next reference Figure 4 In one form of this technology, for example, the tube of an air conduit 8000 is capable of conducting electricity (with power supply voltage and current and / or signal voltage and current) over at least a portion of its length. The air conduit 8000 may, for example, form part of an air circuit 4170 for a patient interface 3000 and / or a positioning and stabilization structure 3300. For example, the air conduit 8000 may be integrally or partially formed as... Figure 3B The patient interface 3000 shown has a positioning and stabilization structure 3300, or as shown in the figure. Figure 1C The air circuit 4170 shown has tube 3350.

[0121] According to one form of the technology, the air duct 8000 includes an outer fabric layer 8010 and at least one inner layer 8020 comprising a polymer layer 8030. In an example, the innermost layer 8022 is a substantially airtight polymer layer 8030.

[0122] In this example, the outer fabric layer 8010 is a conductive (e.g., conductive) fabric. In other examples, at least one of the inner layers 8020 includes a conductive coating 8050 (see...). Figure 8 In some forms of this technology, the outer fabric layer is a conductive fabric 8040, and one of the inner layers 8020 includes a conductive coating 8050.

[0123] In one form of this technology, the conductive coating 8050 and / or the conductive fabric 8040 are configured to heat the air duct 8000 or at least the innermost layer 8022 when conducting current. Additionally or alternatively, the conductive coating 8050 and / or the conductive fabric 8040 may be configured to transmit power and / or electrical signals between components of a system for treating respiratory disorders (e.g., from an RPT device to an actuator or valve), as further described below.

[0124] The outer fabric layer 8010 can be permanently bonded to the polymer layer 8030, or it can take the form of a removable cover.

[0125] The removable cover may also consist of a fabric outer layer 8010 having a conductive coating 8050. In other instances, the conduit may include a removable cover comprising a fabric outer layer and a conductive coating 8050, as well as an inner polymer layer 8330 or an inner fabric layer.

[0126] conductive fabric

[0127] In this example, conductive wires or fibers may be formed as part of a fabric that forms part of the air duct 8000.

[0128] Fabrics can be formed by knitting (including cylindrical knitting or 3D knitting), weaving, braiding or any similar process.

[0129] For example, such as Figure 5 As shown, the outer fabric layer 8010 can be a conductive fabric 8040, such as a knitted fabric 8060. Highly deformable conductive fibers 8070 (e.g., yarns composed of a mixture of conductive and non-conductive fibers, possessing mechanical properties suitable for knitting processes) can be knitted into the fabric 8060, such that they form part of the structure of the fabric 8060. In another example (not shown), conductive fibers can be interwoven into the knitted fabric without forming part of the fabric structure (e.g., not forming part of the loop rows of fabric 8060). This may be particularly suitable if the conductive fibers 8070 have relatively low flexibility (e.g., pure metal monofilament fibers from steel, titanium, aluminum, silver, gold, or copper, with a fine diameter of 1 to 80 μm), as their mechanical properties may not allow their use in knitting processes.

[0130] Conductive fiber 8070 may include one or more conductive polymers, such as polyacetylene, polypyrrole, and polyaniline. Conductive fiber 8070 may also include suitable metals and / or non-conductive materials coated with a suitable conductive coating (e.g., carbon nanotubes or metal particles).

[0131] Next reference Figure 6 In one example, fabric layer 8010 may be formed of a woven fabric comprising warp yarns 8080 and weft yarns 8090. At least one of the warp yarns 8080 and weft yarns 8090 may comprise conductive fiber 8070.

[0132] Next reference Figure 7 In another example, the fabric layer 8010 may be woven. At least one conductive fiber 8070 may be incorporated into the fabric 8010.

[0133] In other examples of this technology, conductive fabric fibers 8070 may be provided to the surface (e.g., the inner surface) of fabric layer 8010. In one example, conductive portions, such as conductive fibers 8070, may be applied to the surface of fabric layer 8010 via an embroidery process. In another example, conductive fibers 8070 may be attached to the surface of fabric layer 8010 via a custom fiber lay-up (TFP) process, which involves sewing roving material of the conductive fibers to the surface of the fabric.

[0134] polymer layer

[0135] Next reference Figure 8In one example, conductive coating 8050 (or multiple such coatings) may be provided to the outer surface of polymer layer 8030 using conductive ink, paste, liquid metal gel, or the like. In one example, screen printing is used to deposit the conductive material. In other examples, conductive coating 8050 may comprise metal and / or carbon particles.

[0136] The conductive coating 8050 preferably defines conductive traces (or multiple such traces) on the surface of the polymer layer 8030, rather than coating the entire surface of the polymer layer 8030.

[0137] Intermediate layer

[0138] Next reference Figure 9 In one example, the air duct 8000 may include one or more intermediate inner layers 8100 located inside the outer fabric layer 8010 (e.g., radially inward) but outside the polymer layer 8030. At least one of the intermediate layers 8100 is 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 may include alternative conductive elements, such as one or more wires and / or sheets of conductive material.

[0139] Spiral trace

[0140] In an example configured to heat an air duct 8000, at least one conductive portion of the air duct 8000 (e.g., conductive fiber 8070 or conductive surface coating 8050) may be configured in a generally helical path around the air duct 8000. In other examples, the conductive portion may be oriented substantially longitudinally along the length of the duct.

[0141] Electrical / electronic components

[0142] Return to reference Figure 4 The air duct 8000 may include suitable electrical components 8120, such as flow sensors, humidity sensors, and / or temperature sensors (e.g., thermocouples, platinum resistance thermometers, or thermistors). Further details of such components are disclosed in U.S. Patent Application Publication 2008 / 0105257 A1, the contents of which are incorporated herein by reference. Such electrical components may be electrically connected to a controller (e.g., the controller of an RPT device and / or a humidifier) ​​via the air duct 8000, for example, via one or more conductive fibers 8070.

[0143] In this example, the air duct 8000 may also include one or more antennas, such as Bluetooth antennas, Wi-Fi antennas, and / or RFID antennas. Such antennas may also be electrically connected to a controller (such as the controller of an RPT device and / or a humidifier) ​​via the air duct 8000, for example, via one or more conductive fibers 8070.

[0144] air circuit

[0145] According to one aspect of the present technology, the air circuit 4170 is a conduit or tube (such as the conductive tube described above) which is constructed and arranged to allow airflow to travel between two components, such as the RPT device 4000 and the patient interface 3000, during use.

[0146] Specifically, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block of the RPT device and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, separate branches of the circuit may exist for inhalation and exhalation. In other cases, a single branch is used.

[0147] Supplemental gas delivery

[0148] In one form of this technology, a supplemental gas (e.g., oxygen) is delivered to one or more points in a pneumatic path, such as upstream of a pneumatic block, to an air circuit 4170, and / or to a patient interface 3000.

[0149] humidifier

[0150] Humidifier Overview

[0151] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 1A As shown), it changes the absolute humidity of the air or gas delivered to the patient relative to the ambient air. Typically, a humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to the ambient air) before it is delivered to the patient's airway.

[0152] Glossary

[0153] For the purposes of this disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0154] General Rules

[0155] Air In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean certain other combinations of breathable gases, such as oxygen-enriched air.

[0156] Surrounding environment:In some forms of this technology, the term "surrounding environment" will be considered to mean (i) the outside of the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0157] For example, the ambient humidity relative to a humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity in the room where the patient sleeps. This ambient humidity can differ from the humidity outside the patient's room.

[0158] In another instance, environmental stress can be either pressures immediately surrounding the body or pressures outside the body.

[0159] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the room where the patient is located, rather than noise generated by, for example, the RPT device or noise emanating from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0160] Automated Positive Airway Pressure (APAP) Therapy CPAP therapy, in which treatment pressure is automatically adjusted between minimum and maximum based on the presence or absence of SDB event indicators, such as between each breath.

[0161] Continuous positive airway pressure (CPAP) therapy Respiratory pressure therapy, in which the therapeutic pressure is kept substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet is slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to the detection of signs of partial upper airway obstruction and decreasing when signs of partial upper airway obstruction are not present.

[0162] Flow rate Flow velocity refers to the amount (or mass) of air transported per unit time. Flow velocity can refer to an instantaneous quantity. In some cases, a reference to flow velocity will be a scalar quantity, i.e., a quantity that only has a value. In other cases, a reference to flow velocity will be a vector quantity, i.e., a quantity that has both a value and a direction. Flow velocity can be represented by symbols. Q The term "flow rate" is sometimes simply abbreviated as "flow rate" or "airflow".

[0163] In the case of patient breathing, the flow rate can be nominally positive for the inspiratory portion of the respiratory cycle and therefore negative for the expiratory portion. Device flow rate Qd This is the air velocity leaving the RPT device. Total velocity. Qt It is the flow rate of air and any supplemental gases reaching the patient interface via the air circuit. (Airflow rate) Qv This is the flow rate of air leaving the vent to allow for the flushing of exhaled air. Leakage flow rate. QlThis is a leaking flow rate from the patient interface system or elsewhere. (Respiratory flow rate) Qr It is the airflow rate received from the patient's respiratory system.

[0164] Flow therapy Breathing therapy involves delivering a flow of air to the airway inlet at a controlled flow rate known as the therapeutic flow rate, which is typically positive throughout the patient’s respiratory cycle.

[0165] humidifier The term humidifier will be considered to refer to a humidifying device that is constructed and arranged or configured with a physical structure that provides a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve a patient’s medical respiratory condition.

[0166] leakage The term "leak" will be used to describe an unintended airflow. In one instance, a leak might occur due to an incomplete seal between the mask and the patient's face. In another instance, a leak might occur in a rotating bend leading to the surrounding environment.

[0167] Conducted noise (acoustic) Conducted noise, as used in this document, refers to noise transmitted to the patient through pneumatic paths, such as air circuits and patient interfaces, 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.

[0168] Radiated noise (acoustic) Radiated noise in this document refers to noise transmitted to the patient by the surrounding 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.

[0169] Ventilation noise (acoustic) Ventilation noise in this document refers to noise generated by the flow of air through any ventilation opening, such as the ventilation port of the patient interface.

[0170] Oxygen-rich air Oxygen-rich air is air with an oxygen concentration greater than that of the atmosphere (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-rich air" is sometimes simply referred to as "oxygen".

[0171] Medical oxygen Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0172] patient: People, regardless of whether they have respiratory illnesses.

[0173] pressureForce per unit area. Pressure can be expressed in a series of units, including cmH2O, gf / cm². 2 And hectopascals. 1 cmH2 equals 1 gf / cm³ 2 And approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m) 2 =1 millibar to 0.001 atmospheres (atm). In this specification, unless otherwise stated, pressure is given in cmH2O.

[0174] Pressure in the patient interface is represented by symbols Pm Give, and treat stress with symbols Pt The treatment pressure is given as the pressure transmitted through the interface at the current moment. Pm The target value obtained.

[0175] Respiratory pressure therapy Air is supplied to the airway inlet at a therapeutic pressure that is normally positive relative to the atmosphere.

[0176] Ventilator Mechanical devices that provide pressure support to patients to perform some or all of their breathing tasks.

[0177] Other notes

[0178] This patent document discloses a portion of copyrighted material. The copyright holder does not object to any fax copying of the patent document or patent disclosure appearing in the patent office's patent documents or records, but retains all copyrights.

[0179] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other value or intermediate value within the range are included within this technique. The upper and lower limits of these intermediate ranges may be independently included within the intermediate range and also within the scope of this technique, but are subject to any explicitly excluded limitations within the range. Where the range includes one or two limitations, the range excluding one or both of those included limitations is also included in this technique.

[0180] Furthermore, where one or more values ​​are stated herein as part of the implementation of this technique, it should be understood that such values ​​may be approximate unless otherwise stated, and such values ​​may be used for any appropriate valid number of digits to the extent that a practical technical implementation may allow or require them.

[0181] Furthermore, as used herein, “about,” “substantially,” “approximately,” or any similar terms mean + / - 5% to 10% of the stated value.

[0182] 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 invention pertains. While any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0183] When a particular material is determined to be used for constructing a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0184] It must be noted that, unless the context explicitly specifies otherwise, as used herein and in the appended claims, the singular forms “a”, “an” and “the” include their plural equivalents.

[0185] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. This document should not be construed as an admission that the present technology is not entitled to precedence over such publications due to prior inventions. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0186] The terms “comprises” and “comprising” should be understood as referring to each element, component, or step in a non-exclusive manner, indicating the marked element, component, or step that may be present or utilized, or a combination with other unmarked elements, components, or steps.

[0187] The headings included in the detailed description are for the reader's convenience only and should not be used to limit the subject matter found throughout the disclosure or claims. These headings should not be used to interpret the scope or limit of the claims.

[0188] Although the techniques described herein have been illustrated with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may imply specific details that are not necessary for practicing the techniques. For example, although the terms "first" and "second" may be used, they are not intended to indicate any order unless otherwise stated, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects may be performed simultaneously or even concurrently.

[0189] Therefore, it should be understood that various modifications can be made to the illustrative examples and other arrangements can be designed without departing from the spirit and scope of this technology.

[0190] List of reference numerals

[0191]

Claims

1. An air duct for treating respiratory disorders, the air duct comprising a fabric outer layer and at least one inner layer comprising a polymer layer, characterized in that The outer fabric layer is a conductive fabric and / or at least one of the inner layers includes a conductive coating.

2. The air duct according to claim 1, wherein the fabric layer comprises at least one conductive fiber.

3. The air duct according to claim 1, wherein the fabric layer is formed by cylindrical knitting or weaving, and at least one of the weft yarns is a conductive fiber.

4. The air duct of claim 1, wherein the fabric layer is formed by conventional knitting or cylindrical knitting, and at least one of the warp yarns is a conductive fiber.

5. The air duct of claim 1, wherein the fabric is formed by a weaving process, and at least one of the yarns is a conductive fiber.

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

7. The air duct according to any one of claims 1 to 6, wherein at least one of the inner layers comprises a conductive element.

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

9. The air duct according to any one of claims 1 to 8, wherein at least one of the inner layer and / or conductive fabric is configured to conduct electrical signals.

10. The air duct according to any one of claims 1 to 9, wherein at least one of the inner layer and / or conductive fabric is configured to conduct electricity.

11. The air duct according to any one of claims 1 to 10, wherein at least one of the inner layer and / or conductive fabric is configured to heat the air duct when conducting an electric current.

12. The air duct according to any one of claims 1 to 11, wherein the air duct includes 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 conductive fabric and / or conductive coating.

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

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

15. An air duct for treating respiratory disorders, the air duct comprising a fabric outer layer and at least one inner layer comprising a polymer layer, characterized in that The air duct further includes at least one conductive intermediate layer.

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

17. The air duct according to any one of claims 15 or 16, wherein the conductive intermediate layer is configured to conduct electrical signals.

18. The air duct according to any one of claims 15 or 16, wherein the conductive intermediate layer is configured to conduct electricity.

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

20. The air duct according to any one of claims 15 to 19, wherein the air duct includes 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 conductive intermediate layer.

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

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

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