Textile covering for respiratory pressure therapy (RPT) devices
By using textile covers to absorb sound from the respiratory pressure therapy device and improving the patient interface and device components, the comfort, cost, and ease of use issues of existing devices have been addressed, improving patient compliance and data management efficiency.
Patent Information
- Application Number
- CN202480036483.2
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-04-05
- Filing Date
- 2024-04-04
- Publication Date
- 2026-03-06
AI Technical Summary
Existing respiratory therapy devices have shortcomings in terms of comfort, cost, ease of use and manufacturability, and data management and noise issues have not been effectively resolved, affecting patient compliance.
The device utilizes textile coverings to absorb sound generated by respiratory pressure therapy devices and offers portable and home-washable medical equipment through improved patient interface design and ease of use of device components, combined with a data management system to enhance comfort and adherence.
It improves the comfort and ease of use of respiratory therapy devices, reduces costs, enhances patient compliance, and simplifies the data management process.
Smart Images

Figure CN121620404A_ABST
Abstract
Description
[0001] This patent document contains copyrighted material. The copyright holder does not object to the reproduction of these patent documents or patent disclosures by any person in the form they appear in the patent office documents or records, but otherwise reserves all copyright rights. Cross-reference to related applications
[0002] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 494,438, filed April 5, 2023, the entire contents of which are incorporated herein by reference. Technical Field 2.1 Technical Field This technology relates to one or more of the following: 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
[0004] 2.2 Description of related technologies 2.2.1 The Human Respiratory System and Its Disorders The human respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airway.
[0005] The airways consist of a series of branching ducts, which 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 and allowing carbon dioxide to move in opposite directions. The trachea divides into the left and right main bronchi, which eventually further divide into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branches of the airways lead to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See John B. West's *Physiology of Respiratory Systems*, published in 2012 by Lippincott Williams & Wilkins. Respiratory Physiology 9th edition of "The 9th Edition ...
[0006] A range of breathing disorders exist. Some disorders may be characterized by specific events, such as apnea, hypoventilation, and hyperventilation.
[0007] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.
[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It is caused by a combination of abnormally small loss of normal upper airway and muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal wall during sleep. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can cause cardiovascular disease and brain damage. The syndrome is a common disorder, especially in middle-aged overweight men, but those affected may not be aware of the problem, see, for example, U.S. Patent No. 4,944,310 (Sullivan).
[0009] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as the CSR cycle. CSR is characterized by repeated deoxygenation and reoxidation of arterial blood. CSR can be harmful due to repetitive hypoxia. In some patients, CSR is associated with recurrent awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload, see, for example, U.S. Patent No. 6,532,959 (Berthon-Jones).
[0010] Respiratory failure is a broad term encompassing respiratory disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure may cover some or all of the following disorders.
[0011] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.
[0012] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.
[0013] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These include increased air resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.
[0014] Neuromuscular disease (NMD) is a broad term encompassing many conditions and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.
[0015] Chest wall disorders are a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.
[0016] A range of therapies have been used to treat or improve these conditions. Furthermore, other healthy individuals can utilize these therapies to prevent respiratory distress. However, these have many drawbacks.
[0017] 2.2.2 Treatment 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 aforementioned respiratory disorders.
[0018] 2.2.2.1 Respiratory pressure therapy 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 chest tubes).
[0019] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as an air 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 therapy can be voluntary, and therefore patients may choose not to adhere to the therapy if they find the device used to provide such therapy to be uncomfortable, difficult to use, expensive, or unsightly.
[0020] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to assist breathing and / or maintain adequate oxygen levels by performing some or all of the work of breathing. Ventilation support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.
[0021] Non-invasive ventilation (IV) provides ventilation support for patients who are unable 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.
[0022] 2.2.2.2 Flow Therapy Not all respiratory therapies are designed to deliver a prescribed therapeutic pressure. Some respiratory therapies are designed to deliver a prescribed respiratory volume 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 example, high-flow therapy (HFT) delivers a continuous, heated, humidified flow of air to the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that can be maintained substantially 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 of air at the airway inlet improves ventilation efficiency by flushing or washing out exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes referred to as dead space therapy (DST). Other benefits may include increased warmth and humidification (which may be beneficial in secretion management) and the possibility of appropriately increasing airway pressure. As an alternative to constant flow, therapeutic flow can follow a curve that varies throughout the respiratory cycle.
[0023] Another form of flow therapy is long-term oxygen therapy (LTOT), or supplemental oxygen therapy. Doctors can prescribe a continuous flow of oxygen-enriched air into the patient's airway at a specific oxygen concentration (from 21% to 100% of the oxygen fraction in ambient air) and at a specific flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.).
[0024] 2.2.3 Respiratory Therapy System 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 a condition without treating it.
[0025] 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.
[0026] 2.2.3.1 Patient Interface Patient interfaces can be used to attach breathing equipment to its 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 patient's mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the therapy to be administered, the patient interface can form a seal with, for example, 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 approximately 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 approximately 10 cmH2O. For flow-through therapy 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.
[0027] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the various therapies described above, such as by operating the device to generate an airflow for delivery to an interface in the airway. 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.
[0028] Pneumatic generators are known in a variety of applications, such as industrial-scale ventilation systems. However, pneumatic generators for medical applications have specific requirements that more general pneumatic generators cannot meet, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may have disadvantages regarding one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.
[0029] One example of the special requirements for certain RPT devices is acoustic noise.
[0030] Noise output level table for existing RPT devices (only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).
[0031]
[0032] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Inc. Another example of an RPT device is a ventilator. Ventilators, such as the ResMed Stellar™ series of adult and pediatric ventilators, can provide invasive and non-invasive non-dependent ventilatory support for a range of patients to treat various conditions, including but not limited to NMD, OHS, and COPD.
[0033] The ResMed Elisée™ 150 and ResMed VS III™ ventilators provide support for invasive and non-invasive ventilation in adults and pediatric patients for the treatment of a variety of conditions. These ventilators offer volumetric and pressure-dependent ventilation modes via single- or dual-branch circuits. RPT devices typically include a pressure generator, such as a motor-driven blower or compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, the airflow can be supplied to the patient's airway at positive pressure. The RPT device outlet is connected via an air circuit to a patient interface such as those described above.
[0034] Device designers may face an infinite number of choices. Design standards often conflict, meaning that some design choices are unconventional or unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to minute, subtle changes in one or more parameters.
[0035] 2.2.3.3 Air Circuit An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system, such as the RPT device and the 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.
[0036] 2.2.3.4 Humidifier Delivering airflow without humidification can lead to airway dryness. Using a humidifier with an RPT device and patient interface generates humidified gas, which minimizes nasal mucosal dryness and increases patient airway comfort. Additionally, in cooler climates, warm air applied to the area within and around the patient interface on the face is generally more comfortable than cold air.
[0037] Many artificial humidification devices and systems are known, however, they do not meet the specific requirements of medical humidifiers.
[0038] Medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to ambient air, typically in areas where patients sleep or rest (e.g., in hospitals). Medical humidifiers intended for bedside placement can be small. They can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air inhaled by the patient; however, these systems also humidify and / or heat the entire room, which can cause discomfort for the occupant. Furthermore, medical humidifiers may have more stringent safety constraints than industrial humidifiers.
[0039] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide insufficient humidification, and some may be difficult or inconvenient for patients to use.
[0040] 2.2.3.5 Data Management There may be clinical reasons for obtaining data to determine whether a patient receiving respiratory therapy is "adherent," such as the patient having used their RPT device according to one or more "adherence rules." An example of an adherence rule for CPAP therapy is that, in order to be considered adherent, the patient is required to use the RPT device for at least four hours each night for at least 21 or 30 consecutive days. To determine patient adherence, the RPT device provider (such as a healthcare provider) may manually obtain data describing the therapy used by patients using the RPT device, calculate usage rates over a predetermined time period, and compare them to the adherence rules. Once the healthcare provider has determined that the patient has used their RPT device according to the adherence rules, the healthcare provider may notify a third party that the patient is adherent.
[0041] The patient's treatment may benefit from other aspects of communicating treatment data to third parties or external systems.
[0042] Existing processes for communicating and managing this type of data may have one or more of the following problems: high cost, time-consuming, and error-prone.
[0043] 2.2.3.6 Ventilation technology Some forms of therapeutic systems may include a vent to allow flushing of exhaled carbon dioxide. The vent may allow gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the outside of the patient interface (e.g., into the environment).
[0044] Ventilation ports may include orifices through which gas can flow during the use of the mask. Many such vents are noisy. Others may become clogged during use and therefore provide insufficient flushing. Some vents may, for example, disturb the sleep of the patient's bed partner by causing noise or concentrated airflow.
[0045] ResMed has developed many improved mask ventilation technologies, see, for example, International Patent Application Publication No. WO 1998 / 034665; International Patent Application Publication No. WO 2000 / 078381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.
[0046] The noise meter for the existing face mask (ISO 17510-2:2007, pressure of 10 cmH2O at 1 m)
[0047] ( (Single sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).
[0048] The sound pressure levels for each object are listed below.
[0049] 2.2.4 Screening, Diagnosis and Monitoring System Polysomnography (PSG) is a routine system used for diagnosing and monitoring cardiopulmonary disorders, and its application typically involves a clinical specialist. 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). PSG for treating sleep-disordered breathing 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 expensive and inconvenient. In particular, it is not suitable for home screening / diagnosis / monitoring of sleep-disordered breathing.
[0050] Screening and diagnosis generally describe the identification of a condition from its signs and symptoms. Screening typically yields a true / false result, indicating whether a patient's SDB is severe enough to warrant further investigation, while diagnosis provides clinically actionable information. Screening and diagnosis tend to be one-off processes, while monitoring disease progression can continue indefinitely. Some screening / diagnostic systems are only for screening / diagnosis, while others can also be used for monitoring.
[0051] 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 differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times. Summary of the Invention
[0052] 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.
[0053] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.
[0054] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.
[0055] One aspect of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.
[0056] Another aspect of this technology relates to a textile cover for absorbing sound generated by an RPT device. The textile cover has at least one open end and a hollow interior for receiving the RPT device.
[0057] In further examples: a) the textile cover has a first open end and a second open end; and / or b) the textile cover has a tubular configuration.
[0058] Another aspect of this technology relates to a textile cover that absorbs sound generated by the RPT device by covering the RPT device and frictionally engaging the textile cover with the outer surface of the housing of the RPT device.
[0059] Another aspect of this technology relates to a textile cover for absorbing sound generated by an RPT device. The textile cover has an open end at its edge. This edge has a ribbed textile structure.
[0060] In a further example: a) the ribbed textile structure at the edge is configured to elastically engage the RPF device; and / or b) the textile cover has another edge with a textile structure different from the ribbed textile structure; and / or c) the edge with the ribbed textile structure has increased stretchability compared to other parts of the textile cover.
[0061] In further examples: a) other parts of the textile covering have a textile structure different from the ribbed textile structure; and b) the increased stretchability of the edges is due to the different textile structure.
[0062] Another aspect of this technology relates to a textile cover for absorbing sound generated by an RPT device, the textile cover comprising a body including a first open end and a second open end, wherein the first open end includes a mating edge configured to engage with a recess at a first end of the RPT device, wherein the second open end includes a ribbed edge for resiliently engaging a second end of the RPT device, and wherein the textile cover is sized to frictionally engage the outer surface of the RPT device.
[0063] Another aspect of this technology relates to a sound-absorbing covering for a respiratory therapy (RPT) device for treating sleep-disordered breathing. The sound-absorbing covering includes: a body made of textile material and having a tubular configuration with a hollow interior, wherein the body includes at least one open end, wherein the hollow interior of the body is configured to receive a housing of the RPT device such that the body at least partially surrounds the housing in contact with it, and wherein the textile material is configured to absorb sound radiated from the housing when the housing is received within the hollow interior and the RPT device is in use.
[0064] In a further example: a) at least one open end includes a first open end and a second open end, the body having a first textile structure along a first edge at the first open end and a second textile structure along a second edge at the second open end, the first textile structure being different from the second textile structure; and b) the second textile structure provides increased stretchability to the second edge of the body compared to the first edge; and / or c) the second textile structure is a ribbed textile structure, and the second edge is configured to elastically engage the RPT device.
[0065] Another aspect of this technology relates to a treatment system for treating sleep-disordered breathing. The treatment system includes a respiratory pressure therapy (RPT) device for supplying positive pressure breathable gas, the RPT device having a housing with an outer surface; and a textile cover according to any of the foregoing aspects, wherein the textile cover has a hollow interior configured to receive the RPT device, and the textile cover is configured to frictionally engage the outer surface of the RPT device.
[0066] One aspect of this technology is a method for manufacturing equipment.
[0067] 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.
[0068] One aspect of this technology is that it is an easy-to-use medical device, for example, for use by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using this type of medical device.
[0069] One aspect of this technology is a portable RPT device that can be carried by a person (e.g., in a person's home).
[0070] 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.
[0071] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors such as dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.
[0072] Of course, some of these aspects can form sub-aspects of this technology. Furthermore, sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.
[0073] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description
[0074] The technology is illustrated in the accompanying drawings by way of example and not limitation, and the same reference numerals in the drawings denote similar elements, including: 4.1 Breathing Therapy System Figure 1A A system including a patient 1000 wearing a patient interface 3000 in the form of a nose pillow, which receives a positive pressure air supply from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient is sleeping in a supine position.
[0075] Figure 1B A system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask is shown, which 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.
[0076] 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.
[0077] 4.2 Respiratory System and Facial Anatomy Figure 2A 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.
[0078] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, supralabial and sublabial folds, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.
[0079] Figure 2CIt is a frontal view of the face with several marked surface anatomical features, including the upper lip, upper vermilion, lower vermilion, lower lip, mouth width, inner canthus, nasal alae, nasolabial groove, and corners of the mouth. It also indicates the directions of up, down, radially inward, and radially outward.
[0080] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal septum, supralipal, sublipal, supramental, nasal ridge, nasal alar apex, supraauricular, and subauricular points. It also indicates the vertical and horizontal directions.
[0081] Figure 2E This is another side view of the head. It indicates the approximate location of the Frankfurt plane and the nasolabial angle. The coronal plane is also indicated.
[0082] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial groove, sublipus, upper vermilion border, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and central sagittal plane.
[0083] Figure 2G A side view showing the features of the nasal surface is shown.
[0084] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.
[0085] Figure 2I The diagram shows the medial anatomy of the nose a few millimeters from the central sagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.
[0086] Figure 2J shows a frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also indicated.
[0087] Figure 2K A side view of the skull showing the surface contours of the head and several muscles is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also indicated. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.
[0088] Figure 2L The frontal lateral view of the nose is shown.
[0089] 4.3 Patient Interface Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.
[0090] Figure 3BA schematic diagram of a cross-section passing through the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.
[0091] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.
[0092] Figure 3D A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a zero value.
[0093] Figure 3E A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.
[0094] Figure 3F A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.
[0095] Figure 3G The padding for a face mask comprising two pillows is shown. The outer surface of the padding is indicated. The edges of the surface are indicated. The dome and saddle-shaped areas are indicated.
[0096] Figure 3H The padding used for the face mask is shown. The outer surface of the padding is indicated. The edge of the surface is indicated. The path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle-shaped areas and a vaulted area are indicated.
[0097] Figure 3I The diagram shows a surface with a structure having a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.
[0098] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface shown is in Figure 3I The structure defines a two-dimensional hole.
[0099] Figure 3K It shows Figure 3I A perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is... Figure 3I The surface of the two-dimensional hole is defined in the structure.
[0100] Figure 3L A face mask with an inflatable airbag as padding is shown.
[0101] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the airbag is also shown. This inner surface defines two-dimensional openings in the mask.
[0102] Figure 3N It shows crossing Figure 3L Another cross-section of the mask. The inner surface is also indicated.
[0103] Figure 3O The left-hand rule is shown.
[0104] Figure 3P The right-hand rule is shown.
[0105] Figure 3Q The left ear is shown, including the left ear spiral.
[0106] Figure 3R The right ear is shown, including the right ear spiral.
[0107] Figure 3S A right-handed spiral is shown.
[0108] Figure 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the face mask.
[0109] Figure 3U A view of the inflation chamber 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.
[0110] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The direction of this view is perpendicular to the intermediate contact plane. Figure 3V The sagittal plane in the middle divides the air chamber into two equal parts: the left-hand side and the right-hand side.
[0111] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, which is in Figure 3V The image shows a section taken at the sagittal plane. The "intermediate contact" plane is shown. The intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and contacts the liner of the inflation chamber at exactly two points on the sagittal plane (upper point 3220 and lower point 3230). Depending on the geometry of the liner in this region, the intermediate contact plane can be a tangent at the upper and lower points.
[0112] Figure 3XIt shows Figure 3U The position of the inflation chamber 3200 on the face. When the inflation chamber is in the use position, the sagittal plane of the inflation chamber 3200 substantially coincides with the central sagittal plane of the face. When the inflation chamber is in the use position, the intermediate contact plane substantially corresponds to the "plane of the face". Figure 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is roughly located on the bridge of the nose, while the lower point 3230 is located on the upper part of the lip.
[0113] 4.4RPT device Figure 4A An RPT device of one form according to the present technology is shown.
[0114] Figure 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface as downstream of the blower, regardless of the actual flow direction at any given moment. The item located within the pneumatic path between the blower and the patient interface is downstream of the blower and upstream of the patient interface.
[0115] Figure 4C This is a schematic diagram of the electrical components of one form of RPT device according to the present technology.
[0116] Figure 4C-1 This is a schematic diagram showing the interconnection of various electrical components of the RPT device.
[0117] 4.5 Humidifier Figure 5A An isometric view of one form of humidifier according to the present technology is shown.
[0118] Figure 5B An isometric view of a humidifier according to the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.
[0119] Figure 5C A schematic diagram of one type of humidifier according to the present technology is shown.
[0120] 4.6 Textile Coverings Figure 6A A schematic diagram of a textile covering is shown.
[0121] Figure 6B An example of a CPAP device is shown.
[0122] Figure 6C An example of a textile cover is shown before it is fitted onto a CPAP device.
[0123] Figure 6D An example of a textile cover fitted onto a CPAP device is shown.
[0124] Figure 6E A schematic diagram of a CPAP device with exemplary dimensions is shown.
[0125] Figure 6F An example of a textile cover fitted onto a CPAP device is shown.
[0126] Figure 6G An example of a textile covering is shown. Detailed Implementation
[0127] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.
[0128] The following description provides various examples that may share one or more common features and / or characteristics. It should 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. Furthermore, in any example, any single feature or combination of features can constitute another example.
[0129] 5.1 Therapy In one form, the technology includes a method for treating respiratory distress, the method comprising applying positive pressure to the inlet of the airway of a patient 1000.
[0130] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.
[0131] In some examples of this technology, mouth breathing is restricted, heavily constrained, or prevented.
[0132] 5.2 Respiratory Therapy System 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 or 3800.
[0133] 5.3 Patient Interface According to one aspect of this technology, such as Figure 3AThe illustrated noninvasive patient interface 3000 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 to surround the inlet of the patient's airway to maintain positive pressure at the inlet of the patient's airway. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.
[0134] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, then the patient interface may not be suitable for respiratory pressure therapy.
[0135] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure higher than that of the ambient environment, for example, at least 2, 4, 6, 10 or 20 cmH2O relative to the ambient environment.
[0136] 5.3.1 Sealing Formation Structure In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The area where the seal actually occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.
[0137] In one embodiment, the target seal forming area is located on the outer surface of the seal forming structure 3100.
[0138] In some forms of this technology, the sealing structure 3100 is constructed from a biocompatible material (e.g., silicone rubber).
[0139] The sealing structure 3100 according to this technology can be constructed from a soft, flexible, elastic material (such as silicone).
[0140] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each of which is configured to correspond to a different size and / or shape range. For example, the system may include one type of sealing formation structure 3100 adapted to large-sized heads but not to small-sized heads, while another is adapted to small-sized heads but not to large-sized heads.
[0141] 5.3.1.1 Sealing Mechanism In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure acting on its bottom surface within the inflation chamber 3200, thereby forming a tight sealing engagement with the face. This pressure-assisted mechanism can work in conjunction with the elastic tension in the positioning and stabilizing structure.
[0142] In one embodiment, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm (e.g., about 0.25 mm to about 0.45 mm) that extends around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends at least a portion of the path around the periphery. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from buckling during use.
[0143] In one form, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and arranged in a compressed state, for example as a result of elastic tension in the positioning and stabilizing structure.
[0144] In one form, the seal forming structure includes a tensioning portion. In use, the tensioning portion is maintained tension, for example, by adjacent areas of the sealing flange.
[0145] In one form, the seal forming structure includes an area having an adhesive or bonding surface.
[0146] In some forms of this technology, the sealing structure may include one or more of the following: a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having an adhesive or bonding surface.
[0147] 5.3.1.2 Nasal bridge or nasal ridge area In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the nasal midline or nasal ridge region of the patient's face during use.
[0148] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal when used on the nasal midline or nasal ridge region of a patient's face.
[0149] 5.3.1.3 Upper lip area In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure that forms a seal on the upper lip region (i.e., above the lip) of the patient's face during use.
[0150] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip region of a patient's face during use.
[0151] 5.3.1.4 Chin area In one embodiment, the non-invasive patient interface 3000 includes a sealing structure that forms a seal on the chin area of the patient's face during use.
[0152] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal when used on the chin area of a patient's face.
[0153] 5.3.1.5 Forehead area In one form, the sealing structure forms a seal on the forehead area of the patient's face during use. In this form, the inflatable chamber can cover the eyes during use.
[0154] 5.3.1.6 Nasal pillow In one form, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is configured and arranged to form a seal with the corresponding nostril of the patient's nose.
[0155] A nasal pillow according to one aspect of the present invention includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Additionally, the nasal pillow connection structure of the present invention includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of the truncated cone and the nasal pillow connection structure in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the structure connected to the handle.
[0156] 5.3.1.7 Nose mask only In one embodiment, the patient interface 3000 includes a sealing structure 3100 configured to seal around the inlet of the patient's nasal airway rather than around the patient's mouth. The sealing structure 3100 may be configured to seal over the patient's lips. The patient interface 3000 allows the patient's mouth to remain uncovered. This patient interface 3000 can deliver an air or breathable gas supply to both nostrils of the patient 1000 without delivering it to the mouth. This type of patient interface can be identified as a nasal mask only.
[0157] One form of the nasal mask according to this technology is conventionally recognized as a nasal mask, having a sealing formation 3100 configured to surround the nose on the patient's face and seal above the bridge of the nose. The nasal mask is typically triangular in shape. In one form, the non-invasive patient interface 3000 includes the sealing formation 3100, which, in use, forms a seal against the upper lip region (e.g., above the lip), against at least a portion of the bridge of the nose above the nasal protuberance, and against the patient's face on each side of the nose, such as near the nasolabial folds. Figure 1B The patient interface 3000 shown has this type of sealing structure 3100. The patient interface 3000 can deliver air or breathable gas to the two nostrils of the patient 1000 through a single orifice.
[0158] Another form of nose mask can seal around the lower periphery of a patient's nose without engaging the user's nasal ridge. For example, this type of patient interface 3000 can be identified as a "nose pad" cover, and the sealing forming structure 3100 can be identified as a "nose pad liner." In one form, the sealing forming structure 3100 is configured to form a seal with the lower surface of the nose surrounding the nostrils during use. The sealing forming structure 3100 can be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including sealing the lower and / or anterior surfaces of the nasal protuberance region of the patient's nose and sealing the patient's nasal wings. The sealing forming structure 3100 can seal over the patient's lips. The shape of the sealing forming structure 3100 can be configured to match or closely follow the lower side of the patient's nose and may not contact the nasal midsection region of the patient's nose or any portion of the patient's nose beyond the nasal protuberance. In one form of nose pad, the sealing forming structure 3100 includes a bridge portion that divides the opening into two orifices, each orifice supplying air or breathable gas to a corresponding patient nostril during use. The bridge portion can be configured to contact or seal the patient's columella during use. Alternatively, the seal-forming structure 3100 may include a single opening providing airflow or air or breathable gas to both patient nostrils.
[0159] In some forms, the nasal mask alone may include a nasal pillow as described above.
[0160] 5.3.1.8 Nose and mouth mask In one embodiment, the patient interface 3000 includes a sealing structure 3100 configured to seal around an inlet to the patient's nasal airway and around the patient's mouth. The sealing structure 3100 may be configured to seal against the patient's face near the chin area. The patient interface 3000 can deliver air or breathable gas to the nostrils and mouth of the patient 1000. This type of patient interface can be identified as a nasal mask and mouth mask.
[0161] One form of the nose and mouth mask according to the present technology is conventionally recognized as a full-face mask, having a sealing forming structure 3100 configured to seal around the nose, below the mouth, and above the center of the nose on the patient's face. The nose and mouth mask is typically triangular in shape. In one form, the patient interface 3000 includes the sealing forming structure 3100, which, in use, forms a seal on the patient's chin area (which may include the area below and / or directly below the lip), the center of the patient's nose or at least a portion of the bridge of the nose above the nasal protuberance, and the cheek area of the patient's face. Figure 1C The patient interface 3000 shown belongs to this type. This patient interface 3000 delivers air or breathable gas to the nostrils and mouth of the patient 1000 through a single opening. This type of sealing structure 3100 can be referred to as a nose-mouth pad.
[0162] In another form, the patient interface 3000 includes a sealing formation structure 3100 that, in use, forms a seal on the patient's chin region (which may include the area below the patient's lip and / or directly below the lip), on the lower and / or anterior surface of the nasal projection portion of the patient's nose, on each side of the patient's nose, such as near the nasolabial fold, on the alar of the patient's nose, and on the patient's face. The sealing formation structure 3100 may also form a seal against the patient's lips. A patient interface 3000 having this type of sealing formation structure may have a single opening configured to deliver an airflow or breathable gas to the patient's two nostrils and mouth; may have an oral orifice configured to deliver air or breathable gas to the mouth and nasal orifices configured to deliver air or breathable gas to the nostrils; or may have an oral orifice for delivering air to the patient's mouth and two nasal orifices for delivering air to the corresponding nostrils. This type of patient interface 3000 can have a nose and a mouth, with the nose sealed to the patient's face in a position similar to a nose pad.
[0163] In another form of the nose and mouth mask, the patient interface 3000 may include a sealing formation 3100 having a nose including a nasal pillow and an mouth configured to form a seal around the patient's mouth against the patient's face.
[0164] In some forms, the sealing structure 3100 may have a nose portion that is separate from and distinct from the mouth. In other forms, the sealing structure 3100 may form a continuous seal around the patient's nose and mouth.
[0165] It should be understood that the above examples of different forms of patient interface 3000 do not constitute an exhaustive list of possible configurations. In some forms, patient interface 3000 may include combinations of different features of the above examples of nasal mask only and nasal and mouth mask.
[0166] 5.3.2 Inflation Chamber The air chamber 3200 has a periphery whose shape is designed to complement the surface contour of the area on a normal person's face that will form a seal during use. During use, the boundary edges of the air chamber 3200 are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by a sealing structure 3100. The sealing structure 3100 may extend around the entire periphery of the air chamber 3200 during use. In some forms, the air chamber 3200 and the sealing structure 3100 are formed from a single sheet of homogeneous material.
[0167] In some forms of this technology, the air chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the air chamber. Such forms tend to be less noticeable and / or more comfortable for the wearer, which can improve adherence to therapy.
[0168] In some forms of this technology, the air chamber 3200 is made of a transparent material, such as transparent polycarbonate. Using a transparent material reduces the prominence of the patient interface and helps improve adherence to the therapy. The transparent material also helps clinicians observe how the patient interface is positioned and functions.
[0169] In some forms of this technology, the air chamber 3200 is made of a translucent material. The use of a translucent material can reduce the protrusion of the patient interface and help improve adherence to the therapy.
[0170] In some forms, the air chamber 3200 is made of a rigid material such as polycarbonate. The rigid material can provide support for the seal-forming structure.
[0171] In some forms, the air chamber 3200 is made of a flexible material (e.g., a soft, flexible, elastic material such as silicone, textiles, foam, etc.). For example, in one example, it may be formed of a material with a Young's modulus of 0.4 GPa or lower, such as foam. In some forms of this technology, the air chamber 3200 may be made of a material with a Young's modulus of 0.1 GPa or lower, such as rubber. In other forms of this technology, the air chamber 3200 may be made of a material with a Young's modulus of 0.7 MPa or less, for example, a material between 0.7 MPa and 0.3 MPa. An example of such a material is silicone.
[0172] 5.3.3 Positioning and Stabilization Structure The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by a positioning and stabilizing structure 3300. The positioning and stabilizing structure 3300 may include and function as a "headgear" because it engages with the patient's head to hold the patient interface 3000 in a sealed position. Examples of the positioning and stabilizing structure may be as follows... Figure 3A As shown.
[0173] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure in the inflation chamber 3200 to lift the face away (i.e., F). 充气 ).
[0174] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the effects of gravity on the patient interface 3000.
[0175] In some forms, the sum of the various forces can be equal to zero, so that the patient interface 3000 is in equilibrium (e.g., does not move along the patient's face during use). Specifically, gravity Fg and the blowing force Finflation tend to move the seal-forming structure 3100 away from the desired sealing position. A positioning and stabilizing force FPSS is applied to counteract gravity Fg and the blowing force Finflation (as well as any frictional force Ff) and keep the seal-forming structure 3100 properly positioned. While the positioning and stabilizing force FPSS may exceed the sum of gravity Fg and the blowing force Finflation (where any additional positioning and stabilizing force FPSS is balanced by the reaction forces from the patient's head acting on the various parts of the patient interface 3000) and still maintain the seal-forming structure 3100 in the proper sealing position, patient comfort may be sacrificed. Maximum patient comfort can be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilizing force FPSS is just strong enough to achieve this. In some examples, the positioning and stabilizing structure 3300 can be adjustable such that, upon assembly, the positioning and stabilizing force FPSS is greater than the force required to precisely balance the gravity Fg and the inflation force F to hold the patient interface 3000 sufficiently close against the patient's head, so that destructive forces that may be experienced during use (such as tube resistance or lateral shunting of the inflation chamber 3200 during lateral recumbency) do not break the seal. As described below, when using the patient interface 3000, the various positions of the patient's head can be determined to achieve the positioning and stabilizing force FPSS necessary for balance.
[0176] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.
[0177] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with how a patient wears the device while sleeping. In one example, the positioning and stabilization structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilization structure 3300 includes at least one strip with a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strip.
[0178] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying down in a supine sleeping position, wherein the back area of the patient's head rests on a pillow.
[0179] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying on the pillow in a side-sleeping position with the side of the patient's head on the pillow.
[0180] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible or loose band. This decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, its presence prevents forces acting on the rear from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.
[0181] In one form of this technology, the positioning and stabilizing structure 3300 includes a band constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the band. In another form, the fabric outer layer includes a loop material for engagement with a hook material portion.
[0182] In some forms of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., elastically extendable) band. For example, the band may be configured to be tensioned during use and guide forces to bring the sealing structure into sealed contact with a portion of the patient's face. In an example, the band may be configured as a tie.
[0183] In one form of this technology, the positioning and stabilizing structure includes a first frenulum, which is constructed and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the supraauricular point of the patient's head and covers a portion of the parietal bone but not the occipital bone.
[0184] In one form of the technology applicable to nasal masks or full-face masks, the positioning and stabilizing structure includes a second strap that is configured and arranged such that, in use, at least a portion of the upper edge of the second strap passes below the subauricular point of the patient's head and covers or is located below the occipital bone of the patient's head.
[0185] In one form of the technology applicable to nose-only masks or full-face masks, the positioning and stabilizing structure includes a third strap that is configured and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.
[0186] In some forms of this technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. An advantage of this is that the strap is more comfortable for the patient when they are sleeping.
[0187] In some forms of this technology, the positioning and stabilizing structure 3300 includes a belt configured to be breathable to allow moisture to be transported through the belt.
[0188] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.
[0189] 5.3.4 Vent In one embodiment, the patient interface 3000 includes a ventilation port 3400 that is configured and arranged to allow flushing of exhaled gases (e.g., carbon dioxide).
[0190] In some configurations, the ventilation port 3400 is configured to allow continuous airflow from the interior of the inflation chamber 3200 to the environment, while the pressure within the inflation chamber is positive relative to the environment. The ventilation port 3400 is configured such that the airflow rate is sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining therapeutic pressure within the inflation chamber during use.
[0191] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.
[0192] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a disconnected structure (e.g., a rotating shaft).
[0193] 5.3.5 Disconnection from the connection structure In one form, the patient interface 3000 includes at least one decoupling structure, such as a spindle or a ball and a socket.
[0194] 5.3.6 Connection Port Connection port 3600 allows connection to air circuit 4170.
[0195] 5.3.7 Forehead Stent In one configuration, the patient interface 3000 includes a forehead support 3700.
[0196] 5.3.8 Anti-suffocation valve In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.
[0197] Port 5.3.9 In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In another embodiment, this allows direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.
[0198] 5.4RPT device An RPT device 4000 according to one aspect of the present technology includes mechanical components, pneumatic components, and / or electrical components, and is configured to perform one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, such as for treating one or more respiratory conditions described elsewhere in this document.
[0199] In one embodiment, the RPT device 4000 is constructed and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.
[0200] The RPT device may have an outer housing 4010, which is formed in two parts: an upper portion 4012 and a lower portion 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a base frame 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.
[0201] The pneumatic path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying positive pressure air, an outlet silencer 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow sensor 4274.
[0202] One or more of the air path objects may be located within a removable integral structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be disposed within an outer housing 4010. In one form, pneumatic block 4020 is supported by, or forms part of, a chassis 4016.
[0203] like Figure 4C As shown, the RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. Alternatively, the RPT device 4000 may include more than one PCBA 4202.
[0204] 5.4.1 Mechanical and Pneumatic Components of the RPT Device An RPT device may include one or more of the following components in a single unit. Alternatively, one or more of the following components may be positioned as separate units.
[0205] 5.4.1.1 Air Filter One form of RPT device according to the present technology may include one air filter 4110, or multiple air filters 4110.
[0206] exist Figure 4B In one embodiment shown, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.
[0207] exist Figure 4B In one embodiment shown, an outlet air filter 4114, such as an antibacterial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.
[0208] 5.4.1.2 Muffler One form of RPT device according to the present technology may include one or more mufflers 4120.
[0209] In one form of this technology (for example, see...) Figure 4B The inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140.
[0210] In one embodiment of this technology, the outlet silencer 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800.
[0211] 5.4.1.3 Pressure Generator In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be located in a volute. The blower may deliver an air supply, for example, at a rate up to about 120 liters per minute and at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O, when delivering respiratory pressure therapy. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013 / 020167.
[0212] The pressure generator 4140 can be controlled by the therapy device controller 4240.
[0213] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.
[0214] 5.4.1.4 Transducer The transducer can be inside or outside the RPT device. An external transducer can be located on, for example, an air circuit (e.g., a patient interface) or form part of an air circuit. The external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits data or transfers it to the RPT device.
[0215] In one form of this technology (for example, see...) Figure 4B One or more transducers 4270 are located upstream and / or downstream of pressure generator 4140. One or more transducers 4270 may be configured and arranged to generate signals representing characteristics of airflow at that point in the pneumatic path, such as flow rate, pressure, or temperature.
[0216] In one form of this technology, one or more transducers 4270 may be located near the patient interface 3000 or 3800.
[0217] In one embodiment, the signal from transducer 4270 can be filtered, for example, by low-pass filtering, high-pass filtering, or band-pass filtering.
[0218] 5.4.1.4.1 Flow Sensor The flow sensor 4274 according to this technology can be based on a differential pressure transducer, such as the SDP600 series differential pressure transducer from SENSIRION, Switzerland.
[0219] In one configuration, the signal generated by the flow sensor 4274 and representing the flow rate is received by the central controller 4230.
[0220] 5.4.1.4.2 Pressure Sensor The pressure sensor 4272 according to this technology is positioned in fluid communication with the pneumatic path. An example of a suitable pressure sensor is a transducer from the HONEYWELL ASDX series. An alternative suitable pressure sensor is a transducer from the GENERALELECTRIC NPA series.
[0221] In one configuration, the signal generated by pressure sensor 4272 and representing pressure is received by central controller 4230.
[0222] 5.4.1.4.3 Motor speed transducer In one embodiment of this technology, a motor speed transducer 4276 is used to determine the rotational speed of a motor 4144 and / or a blower 4142. The motor speed signal from the motor speed transducer 4276 can be provided to a therapy device controller 4240. The motor speed transducer 4276 can be, for example, a speed sensor, such as a Hall effect sensor.
[0223] 5.4.1.5 Anti-overflow valve like Figure 4B As shown, in one form of this technology, an anti-backflow valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.
[0224] 5.4.2 Electrical components of the RPT device 5.4.2.1 Power Supply The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.
[0225] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of this technology, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.
[0226] like Figure 4C-1 As shown, power supply 4210 can provide power to input device 4220, central controller 4230, output device 4290, and pressure generator 4140. Power supply 4210 can also provide power to other components of RPT device 4000 (or humidifier 5000, as described above).
[0227] 5.4.2.2 Input Device In one form of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow human interaction with the device. The buttons, switches, or dials can be physical or software devices accessible via a touchscreen. In one form, the buttons, switches, or dials can be physically connected to an external housing 4010, or in another form, they can communicate wirelessly with a receiver electrically connected to a central controller 4230.
[0228] In one form, the input device 4220 may be configured and arranged to allow a person to select values and / or menu options.
[0229] 5.4.2.3 Central Controller In one embodiment of this technology, the central controller 4230 is one or more processors adapted to control the RPT device 4000. The central controller 4230 in... Figure 4C and Figure 4C-1 As shown in the image.
[0230] Suitable processors may include x86 Intel processors, processors based on ARM® Cortex®-M processors from ARM Holdings, and microcontrollers such as the STM32 series from STMicroelectronics. In some alternative forms of this technology, 32-bit RISC CPUs, such as the STR9 series microcontrollers from STMicroelectronics, or 16-bit RISC CPUs, such as processors from the MSP430 family of microcontrollers manufactured by Texas Instruments, may also be applicable.
[0231] In one form of this technology, the central controller 4230 is a dedicated electronic circuit.
[0232] In one form, the central controller 4230 is an application-specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.
[0233] The central controller 4230 can be configured to receive input signals from one or more transducers 4270, one or more input devices 4220, and / or the humidifier 5000.
[0234] The central controller 4230 can be configured to provide output signals to one or more of the output device 4290, pressure generator 4140, therapy device controller 4240, data communication interface 4280, and humidifier 5000.
[0235] In some forms of this technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 that can be implemented using processor control instructions, which are represented as a computer program stored in a non-transient computer-readable storage medium such as memory 4260. In some forms of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of this technology, some methods may be performed by a remotely located device. For example, a remotely located device may determine the control settings of a ventilator or detect respiratory-related events by analyzing stored data, such as data from any of the sensors described herein.
[0236] 5.4.2.4 Clock RPT device 4000 may include a clock 4232 connected to central controller 4230.
[0237] 5.4.2.5 Therapeutic Device Controller In one form of this technology, the therapy device controller 4240 is a therapy control module 4330, which forms part of an algorithm 4300 executed by the central controller 4230.
[0238] In one form of this technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, an MC33035 brushless DC motor controller manufactured by ONSEMI is used.
[0239] 5.4.2.6 Protection Circuit One or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.
[0240] 5.4.2.7 Memory According to one embodiment of the present technology, the RPT device 4000 includes a memory 4260, such as non-volatile memory. In some embodiments, the memory 4260 may include battery-powered static RAM. In some embodiments, the memory 4260 may include volatile RAM.
[0241] The memory 4260 can be located on PCBA 4202. The memory 4260 can be in the form of EEPROM or NAND flash memory.
[0242] Additionally or alternatively, the RPT device 4000 includes a removable memory 4260, such as a memory card manufactured according to the Secure Digital (SD) standard.
[0243] In one form of this technology, memory 4260 acts as a non-transitory computer-readable storage medium storing computer program instructions that represent one or more methods described herein, such as one or more algorithms 4300.
[0244] 5.4.2.8 Data Communication System In one form of this technology, a data communication interface 4280 is provided, which is connected to a central controller 4230 (see, for example, [link to relevant documentation]). Figure 4C The data communication interface 4280 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.
[0245] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or a processor.
[0246] In one form, the remote external communication network 4282 is the Internet. The data communication interface 4280 can connect to the Internet using wired communication (e.g., via Ethernet or fiber optic) or wireless protocols (e.g., CDMA, GSM, LTE).
[0247] In one form, the local external communication network 4284 utilizes one or more communication standards, such as Bluetooth or consumer infrared protocols.
[0248] In one form, the remote external device 4286 is one or more computers, such as a cluster of networked computers. In another form, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessible to a properly authorized person, such as a clinician.
[0249] The local external device 4288 can be a personal computer, mobile phone, tablet computer, or remote control device.
[0250] 5.4.2.9 Includes optional display and alarm output devices. The output device 4290 according to this technology can take the form of one or more of visual, audio, and tactile units. The visual display can be a liquid crystal display (LCD) or a light-emitting diode (LED) display.
[0251] 5.4.2.9.1 Display Driver The display driver 4292 receives characters, symbols, or images to be displayed on the display 4294 as input and converts them into commands that cause the display 4294 to display those characters, symbols, or images.
[0252] 5.4.2.9.2 Monitor Display 4294 is configured to visually display characters, symbols, or images in response to commands received from display driver 4292. For example, display 4294 may be an eight-segment display, in which case display driver 4292 converts each character or symbol (such as the number "0") into eight logic signals that indicate whether the eight corresponding segments will be activated to display a specific character or symbol.
[0253] 5.4.3 RPT Device Algorithm As described above, in some forms of this technology, the central controller 4230 may be configured to implement one or more algorithms 4300 represented as computer programs stored in a non-transitory computer-readable storage medium (such as memory 4260). The algorithms 4300 are typically grouped into groups called modules.
[0254] In other forms of this technology, a portion or all of algorithm 4300 may be implemented by the controller of an external device, such as a local external device 4288 or a remote external device 4286. In this form, the input signals and / or intermediate algorithm outputs required to represent the portion of algorithm 4300 to be executed at the external device may be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In this type of form, the portion of algorithm 4300 to be executed at the external device may be represented as a computer program, such as having processor control instructions to be executed by one or more processors, stored in a non-transitory computer-readable storage medium accessible to the controller of the external device. Such a program configures the controller of the external device to execute portions of algorithm 4300.
[0255] In this form, therapeutic parameters generated by an external device via the therapeutic engine module 4320 (if thus forming part of the algorithm 4300 executed by the external device) can be transmitted to the central controller 4230 to be passed to the therapeutic control module 4330.
[0256] 5.5 Textile Covers for RPT Devices As mentioned above, RPT devices can be affected by noise generation. A typical CPAP flow generator device may include a microprocessor, blower (motor and fan), motor driver, filters, various sensors, silicone, and foam, all housed in injection-molded plastic with overmolded end caps. The foam, silicone, and housing hold the precision components in place and provide some sound damping characteristics by reducing vibration and absorbing sound. However, this may not be sufficient to reduce the generated noise. Furthermore, as devices become smaller, sound damping and noise cancellation techniques become more important because there is less space to absorb sound and reduce vibration, and motors may need to operate at higher outputs to compensate for the size reduction. For example, noise sources can originate from the blower, and some of this noise is radiated from the device housing, i.e., the solid walls of the housing moving air (such as a speaker). Noise radiated from the housing needs to be absorbed.
[0257] Noise pollution can affect the quality of rest for patients. According to ISO 25267, a sound pressure level below 20 dB is recommended for bedrooms. Prolonged exposure to noise levels of 85 dB or higher can lead to increased blood pressure, increased stress levels, and lasting hearing damage. Therefore, it is necessary to reduce unwanted noise generated by RPT devices. In particular, it is necessary to reduce unwanted noise generated by CPAP generator devices.
[0258] Sound is a change in pressure in air, water, or a similar elastic medium, which can be perceived by the ear as an auditory stimulus. Loudness and pitch are two aspects of sound; loudness is the sound pressure level expressed in decibels (dB), while pitch is the sound frequency expressed in hertz (Hz). Typically, the human ear is sensitive to the range of 20 Hz to 20,000 Hz. Sound propagates as waves and can be considered through its frequency, wavelength, and amplitude. Undesirable sounds can be characterized as noise.
[0259] To reduce noise pollution, noise can be absorbed or blocked. During sound absorption, air particles rub against the insulating material, converting the kinetic energy of the sound into heat energy, thus dissipating the sound energy. Sound absorption limits the energy absorbed by a material and can be expressed as an absorption coefficient (α) in the range of 0 to 1, where 0 represents no absorption and 1 represents maximum absorption or total absorption. Sound insulation involves blocking the transmission of sound.
[0260] In one form of this technology, a textile cover is provided for absorbing sound generated by an RPT device. The textile cover is fitted onto the outer surface of the RPT device to at least partially surround the outer surface of the RPT device. The textile cover includes a body having a first open end and a second open end. The first open end includes a engagement edge configured to mate with a recess at a first end of the RPT device. The second open end includes a ribbed edge (e.g., an edge portion formed by a ribbed textile structure (e.g., a ribbed knit structure)) for resiliently engaging a second end of the RPT device. The textile cover is sized to frictionally engage the outer housing of the RPT device. At this point, the textile cover is fitted snugly to the outer housing of the RPT device. The textile cover may be sized to resiliently engage the outer housing of the RPT device (e.g., the exterior or outer surface of the housing).
[0261] Textile coverings are made of fabric. This fabric can be woven. Woven fabrics are fabrics made by interlacing two or more threads or yarns at right angles to each other. Woven fabrics can be made from a selection of natural and / or synthetic fibers. Examples of such fibers include, but are not limited to, cotton, polyester, and spandex.
[0262] In one form of the present invention, the woven fabric is characterized in that the fiber diameter is from about 1 µm to about 50 µm. In another form of the present invention, the fiber diameter is from about 1 µm to about 45 µm, from about 1 µm to about 40 µm, from about 1 µm to about 35 µm, from about 1 µm to about 30 µm, from about 1 µm to about 25 µm, from about 1 µm to about 20 µm, or from about 5 µm to about 20 µm.
[0263] In one form of this technology, the woven fabric is characterized by a yarn denier of about 2 to about 120. In other forms of this technology, the denier of the fiber is about 3 to about 120, about 4 to about 120, about 5 to about 120, about 6 to about 120, about 7 to about 120, about 8 to about 120, about 9 to about 120, about 10 to about 120, about 11 to about 120, about 12 to about 120, about 13 to about 120, about 14 to about 120, about 15 to about 120, about 20 to about 120, about 30 to about 120, about 40 to about 120, about 50 to about 120, about 60 to about 120, about 70 to about 120, about 80 to about 120, about 90 to about 120, about 2 to about 110, about 2 to about 100, about 2 to about 90, about 2 to about 80, about 2 to about 70, about 2 to about 60, about 2 to about 50, about 2 to about 40, about 2 to about 30, or about 2 to about 20.
[0264] In one form of this technology, the woven fabric is characterized by a total fiber surface area of approximately 10 m². 2Approximately 60 m 2 In other forms of this technology, the total fiber surface area is approximately 15 m². 2 Approximately 60 m 2 Approximately 20 m 2 Approximately 60 m 2 Approximately 25 m 2 Approximately 60 m 2 Approximately 30 m 2 Approximately 60 m 2 Approximately 35 m 2 Approximately 60 m 2 Approximately 40 m 2 Approximately 60 m 2 Approximately 45 m 2 Approximately 60 m 2 or about 50 m 2 Approximately 60 m 2 .
[0265] In one form of this technology, the woven fabric is characterized by an areal density of about 0.5 g / cm³. 3 Approximately 2 g / cm 3 In other forms of this technology, the areal density is approximately 0.7 g / cm³. 3 Approximately 2 g / cm 3 Approximately 0.9 g / cm 3 Approximately 2 g / cm 3 Approximately 1g / cm 3 Approximately 2 g / cm 3 Approximately 1.2 g / cm³ 3 Approximately 2 g / cm 3 Approximately 1.4 g / cm 3 Approximately 2 g / cm 3 Approximately 1.6 g / cm³ 3 Approximately 2g / cm 3 Or approximately 1.8 g / cm 3 Approximately 2 g / cm 3 .
[0266] In one form of the present invention, the woven fabric is characterized by a porosity of about 50% to about 90%. In other forms of the present invention, the porosity is about 55% to about 90%, about 60% to about 90%, about 65% to about 90%, about 70% to about 90%, about 75% to about 90%, about 80% to about 90%, or about 85% to about 90%.
[0267] In one form of this technology, the woven fabric is characterized by a thickness of about 1 µm to about 10 mm. In other forms of this technology, the thickness is about 2 μm to about 10 mm, about 3 μm to about 10 mm, about 4 μm to about 10 mm, about 5 μm to about 10 mm, about 6 μm to about 10 mm, about 7 μm to about 10 mm, about 8 μm to about 10 mm, about 9 μm to about 10 mm, about 10 μm to about 10 mm, about 20 μm to about 10 mm, about 40 μm to about 10 mm, about 50 μm to about 10 mm, about 60 μm to about 10 mm, about 80 μm to about 10 mm, about 100 μm to about 10 mm, about 100 μm to about 9 mm, about 100 μm to about 8 mm, about 100 μm to about 7 mm, about 100 μm to about 6 mm, about 100 μm to about 5 mm, about 100 μm to about 4 mm, about 100 μm to about 3 mm, about 100 μm to about 2 mm, or about 100 μm to about 1 mm.
[0268] The fabric can be a nonwoven fabric. Nonwoven materials, due to their fibrous structure and high total surface area, hold promise for reducing sound pollution in the environment. Density (mass), porosity, bulk density, tortuosity, particle size distribution, and thickness constitute significant physical properties of nonwoven fabrics used in acoustic applications. For example, nonwoven materials made from microfibers and / or high-surface-area fibers such as trefoil cross-sections may be good for noise cancellation. For instance, microfiber fabrics may be advantageous compared to conventional fabrics of similar thickness or weight in terms of sound absorption properties.
[0269] In one form of this technology, the textile covering is made of a nonwoven fabric. A nonwoven fabric is a woven material made of short fibers (short) and long fibers (continuous length) bonded together by chemical, mechanical, thermal, or solvent treatment. Such fabrics are neither woven nor knitted. Nonwoven fabrics are often desirable due to their fiber structure and high total surface area. Nonwoven fabrics can be stapled nonwovens, spunlace nonwovens, spunbond nonwovens, flash-spun nonwovens, air-laid nonwovens, or meltblown nonwovens. Nonwoven fabrics can be made of polypropylene, polyester, viscose fiber, and / or cotton. Nonwoven fabrics can be combined with other materials to form composite fabrics.
[0270] In one form of the present invention, the nonwoven fabric is characterized in that the fiber diameter is from about 1 µm to about 50 µm. In another form of the present invention, the fiber diameter is from about 1 µm to about 45 µm, from about 1 µm to about 40 µm, from about 1 µm to about 35 µm, from about 1 µm to about 30 µm, from about 1 µm to about 25 µm, from about 1 µm to about 20 µm, or from about 5 µm to about 20 µm.
[0271] In one form of the present invention, the nonwoven fabric is characterized by a fiber length of about 1 cm to about 10 cm. In other forms of the present invention, the fiber length is about 1 cm to about 9 cm, about 1 cm to about 8 cm, about 1 cm to about 7 cm, about 1 cm to about 6 cm, about 1 cm to about 5 cm, about 1 cm to about 4 cm, about 1 cm to about 3 cm, or about 1 cm to about 2 cm.
[0272] In one form of the present invention, the nonwoven fabric is characterized in that the denier of the fibers is from about 0.2 to about 20. In other forms of the present invention, the denier of the fibers is from about 3 to about 20, from about 4 to about 20, from about 5 to about 20, from about 6 to about 20, from about 7 to about 20, from about 8 to about 20, from about 9 to about 20, from about 10 to about 20, from about 11 to about 20, from about 12 to about 20, from about 13 to about 20, from about 14 to about 20, from about 15 to about 20, from about 3 to about 19, from about 3 to about 18, from about 3 to about 17, from about 3 to about 16, from about 3 to about 15, from about 3 to about 14, from about 3 to about 13, from about 3 to about 12, from about 3 to about 11, from about 3 to about 10, from about 3 to about 9, from about 3 to about 8, or from about 3 to about 7.
[0273] In one form of this technology, the nonwoven fabric is characterized by a total fiber surface area of approximately 10 m². 2 Approximately 60m 2 In other forms of this technology, the total fiber surface area is approximately 15 m². 2 Approximately 60 m 2 Approximately 20 m 2 Approximately 60 m 2 Approximately 25 m 2 Approximately 60 m 2 Approximately 30 m 2 Approximately 60 m 2 Approximately 35 m 2 Approximately 60 m 2 Approximately 40 m 2 Approximately 60 m 2 Approximately 45 m 2 Approximately 60 m 2 or about 50 m 2 Approximately 60 m 2 .
[0274] In one form of this technology, the nonwoven fabric is characterized by an areal density of about 0.5 g / cm³. 3 Approximately 2 g / cm 3 In other forms of this technology, the areal density is approximately 0.7 g / cm³. 3 Approximately 2 g / cm3 Approximately 0.9 g / cm 3 Approximately 2 g / cm 3 Approximately 1 g / cm 3 Approximately 2 g / cm 3 Approximately 1.2 g / cm³ 3 Approximately 2 g / cm 3 Approximately 1.4 g / cm 3 Approximately 2 g / cm 3 Approximately 1.6 g / cm³ 3 Approximately 2 g / cm 3 Or approximately 1.8 g / cm 3 Approximately 2 g / cm 3 .
[0275] In one form of the present invention, the nonwoven fabric is characterized by a porosity of about 50% to about 90%. In other forms of the present invention, the porosity is about 55% to about 90%, about 60% to about 90%, about 65% to about 90%, about 70% to about 90%, about 75% to about 90%, about 80% to about 90%, or about 85% to about 90%.
[0276] In one form of this technology, the nonwoven fabric is characterized by a thickness of about 1 µm to about 10 mm. In other forms of this technology, the thickness is about 2 μm to about 10 mm, about 3 μm to about 10 mm, about 4 μm to about 10 mm, about 5 μm to about 10 mm, about 6 μm to about 10 mm, about 7 μm to about 10 mm, about 8 μm to about 10 mm, about 9 μm to about 10 mm, about 10 μm to about 10 mm, about 20 μm to about 10 mm, about 40 μm to about 10 mm, about 50 μm to about 10 mm, about 60 μm to about 10 mm, about 80 μm to about 10 mm, about 100 μm to about 10 mm, about 100 μm to about 9 mm, about 100 μm to about 8 mm, about 100 μm to about 7 mm, about 100 μm to about 6 mm, about 100 μm to about 5 mm, about 100 μm to about 4 mm, about 100 μm to about 3 mm, about 100 μm to about 2 mm, or about 100 μm to about 1 mm.
[0277] In one form of this technology, the nonwoven fabric is characterized by a weight of approximately 200 gsm (g / m²). 2From about 200 gsm to about 550 gsm, from about 200 gsm to about 500 gsm, from about 200 gsm to about 450 gsm, from about 200 gsm to about 400 gsm, from about 200 gsm to about 350 gsm, or from about 200 gsm to about 300 gsm.
[0278] In one form of this technology, the textile covering is made of knitted fabric. Knitted fabric is formed by looping single yarns together in both horizontal and vertical directions using a knitting machine. Based on the direction between the loops, knitted fabric can be classified as warp-knitted fabric or weft-knitted fabric. Generally, knitted fabric is softer than woven fabric. The yarn can be made from, but is not limited to, cotton, wool, jute, and viscose fibers.
[0279] In one form of this technology, the knitted fabric is a weft-knitted fabric. In another form of this technology, the knitted fabric is a warp-knitted fabric.
[0280] In one form of this technology, the knitted fabric is characterized by a yarn length of about 1 cm to about 100 cm. In other forms of this technology, the yarn length is about 10 cm to about 100 cm, about 20 cm to about 100 cm, about 30 cm to about 100 cm, about 40 cm to about 100 cm, about 50 cm to about 100 cm, about 60 cm to about 100 cm, or about 70 cm to about 100 cm.
[0281] In one form of this technology, the knitted fabric is characterized by a yarn diameter of about 1 µm to about 50 µm. In other forms of this technology, the yarn diameter is about 1 μm to about 45 μm, about 1 μm to about 40 μm, about 1 μm to about 35 μm, about 1 μm to about 30 μm, about 1 μm to about 25 μm, about 1 μm to about 20 μm, or about 5 μm to about 20 μm.
[0282] In one form of the present invention, the knitted fabric is characterized by a yarn denier of about 2 to about 200. In other forms of the present invention, the yarn denier is about 10 to about 200, about 20 to about 200, about 20 to about 190, about 20 to about 180, about 20 to about 170, about 20 to about 160, about 20 to about 150, about 20 to about 140, about 20 to about 130, about 20 to about 120, about 20 to about 110, or about 20 to about 100.
[0283] In one form of the present invention, the knitted fabric is characterized by a porosity of about 50% to about 90%. In other forms of the present invention, the porosity is about 55% to about 90%, about 60% to about 90%, about 65% to about 90%, about 70% to about 90%, about 75% to about 90%, about 80% to about 90%, or about 85% to about 90%.
[0284] In one form of this technology, the knitted fabric is characterized by a thickness of about 1 µm to about 10 mm. In other forms of this technology, the thickness is about 2 μm to about 10 mm, about 3 μm to about 10 mm, about 4 μm to about 10 mm, about 5 μm to about 10 mm, about 6 μm to about 10 mm, about 7 μm to about 10 mm, about 8 μm to about 10 mm, about 9 μm to about 10 mm, about 10 μm to about 10 mm, about 20 μm to about 10 mm, about 40 μm to about 10 mm, about 50 μm to about 10 mm, about 60 μm to about 10 mm, about 80 μm to about 10 mm, about 100 μm to about 10 mm, about 100 μm to about 9 mm, about 100 μm to about 8 mm, about 100 μm to about 7 mm, about 100 μm to about 6 mm, about 100 μm to about 5 mm, about 100 μm to about 4 mm, about 100 μm to about 3 mm, about 100 μm to about 2 mm, or about 100 μm to about 1 mm.
[0285] In one form of the present invention, the knitted fabric is characterized by a hole radius of about 0.02 cm to about 0.08 cm. In other forms of the present invention, the hole radius is about 0.02 cm to about 0.07 cm, about 0.02 cm to about 0.06 cm, about 0.02 cm to about 0.05 cm, or about 0.02 cm to about 0.04 cm.
[0286] In one form of this technology, the knitted fabric is characterized by a needle hole area of approximately 0.1 mm. 2 approximately 2 mm 2 In other forms of this technology, the pinhole area is approximately 0.1 mm. 2 To approximately 1.8 mm 2 Approximately 0.1 mm 2 To approximately 1.6 mm 2 Approximately 0.1 mm 2 To approximately 1.4 mm 2 Approximately 0.1 mm 2 To approximately 1.2 mm 2 Approximately 0.1 mm 2 approximately 1 mm 2 Approximately 0.1 mm2 To approximately 0.8 mm 2 or about 0.1 mm 2 To approximately 0.6 mm 2 .
[0287] In one form of this technology, the knitted fabric is characterized by a stitch length of about 0.3 cm to about 0.9 cm. For example, the hole area and stitch length can be measured using a Porjectina optical microscope. In other forms of this technology, the stitch length is about 0.3 cm to about 0.8 cm, about 0.3 cm to about 0.7 cm, about 0.3 cm to about 0.6 cm, or about 0.3 cm to about 0.5 cm.
[0288] In one form of this technology, the knitted fabric is characterized by a stitch density (per cm). 2 The number of stitches is approximately 10cm. 2 Approximately 120 cm 2 In other forms of this technology, the stitch density is approximately 20 cm. 2 Approximately 120 cm 2 Approximately 30 cm 2 Approximately 120 cm 2 Approximately 40 cm 2 Approximately 120 cm 2 Approximately 50 cm 2 Approximately 120 cm 2 Approximately 60 cm 2 Approximately 120 cm 2 Approximately 70 cm 2 Approximately 120 cm 2 Approximately 80 cm 2 Approximately 120 cm 2 Approximately 90 cm 2 Approximately 120 cm 2 or about 100 cm 2 Approximately 120 cm 2 .
[0289] In one form of this technology, the knitted fabric is characterized by a knitted fabric weight GSM (grams per square meter) of approximately 60 gsm (g / m²). 2 (Approximately 600 gsm). In other forms of this technology, the weight is approximately 200 gsm to approximately 550 gsm, approximately 200 gsm to approximately 500 gsm, approximately 200 gsm to approximately 450 gsm, approximately 200 gsm to approximately 400 gsm, approximately 200 gsm to approximately 350 gsm, or approximately 200 gsm to approximately 300 gsm.
[0290] In one form of this technology, the knitted fabric includes coated yarns. These yarns may be coated with an anti-slip material. This anti-slip material increases friction between the textile cover and the RPT device to limit or prevent movement of the textile cover relative to the outer surface of the RPT device, particularly when the RPT device is being operated by a patient. The anti-slip material may be silicone, thermoplastic polyurethane (TPU), polyvinyl chloride (PVC), or a combination thereof.
[0291] In one form of this technology, the textile covering is made of a spacer fabric. The spacer fabric comprises a combination of two separate textile pieces interconnected by spacer yarns (forming a spacer layer), giving the fabric a 3D appearance. The spacer fabric may comprise two knitted fabrics separated by spacer yarns. Due to the spacer yarns, a defined distance can be established between the textile pieces. The textile pieces may be constructed similarly or differently to achieve a variety of functions. The spacer layer may comprise monofilaments and / or multifilaments. A monofilament refers to a single solid filament. A multifilament refers to a yarn having multiple filament fibers twisted together. While spacer fabrics with monofilaments can be stiffer, resistant to high pressure, and allow for the directional transport of fluids and heat, spacer fabrics with multifilaments allow for greater movement and flexibility. Therefore, a combination of monofilaments and multifilaments can be used to provide a spacer fabric with desired properties (e.g., stiffness / flexibility). The filaments may be formed from materials selected from polyester, nylon, and / or recycled yarns. Other materials include, but are not limited to, cotton, viscose, rayon, acrylic fibers, elastic fibers, and blended yarns of polyester and cotton / viscose, cotton / acrylic fibers, and polyacrylic fibers in different proportions or combinations.
[0292] In one form of the present invention, the spacer fabric is characterized by a thickness of about 2 mm to about 10 mm. In other forms of the present invention, the thickness is about 2 mm to about 9 mm, about 2 mm to about 8 mm, about 2 mm to about 7 mm, about 2 mm to about 6 mm, or about 2 mm to about 5 mm.
[0293] Other types of fabrics can also be used, such as flat fabrics, warp-knitted fabrics, circular knitted fabrics with large and small rollers, spaced mesh fabrics, and quilted fabrics with filling. Any material used to manufacture the fabric can be used. For example, the material can be selected from virgin and / or recycled polyester, polypropylene, polyamide, various spandex or stretch materials, poly(lactic acid), wool, cotton, bamboo, jute, or combinations thereof. In one form of this technology, the material is an elastic material.
[0294] In one form of this technology, the inner surface of the body includes an anti-slip coating. In this respect, the surface of the fabric that comes into contact with the RPT device during use can be coated with an anti-slip material. The anti-slip material can be silicone resin, thermoplastic polyurethane (TPU), polyvinyl chloride (PVC), or a combination thereof.
[0295] In one form of this technology, the body comprises at least two layers of fabric. The fabric can be layered such that the pores in each fabric layer are offset relative to each other (e.g., the pores in each fabric layer may be offset relative to the pores in at least adjacent fabric layers) in order to reduce the total porosity of the fabric layers. In this way, sound waves can be further blocked by the fabric and thus absorbed.
[0296] In one form of this technology, when the body comprises at least two layers of fabric, the inner layer (which contacts the RPT device during use) includes yarns coated with an anti-slip material. The anti-slip material can be silicone, thermoplastic polyurethane (TPU), polyvinyl chloride (PVC), or a combination thereof. Therefore, if the inner layer fabric is a knitted fabric, using anti-slip coated yarns improves the adhesion between the textile cover and the RPT device. Alternatively, the surface of the inner layer fabric that contacts the RPT device during use can be coated with an anti-slip material.
[0297] In one form of this technology, the body includes a through-hole for exposing a portion of the RPT device. The size and location of this through-hole can be designed such that it exposes buttons and / or indicators on the RPT device. The through-hole can be edged with seam tape to improve the seal of the textile covering to the RPT device, thereby reducing noise leakage from the through-hole.
[0298] In one form of this technology, the body includes a mesh adjacent to a first edge. This mesh may be adjacent to a bonding edge. The mesh may separate the body from the bonding edge. The mesh may be positioned such that it is sandwiched between the fabric of the bonding edge and the body. The mesh may be a mesh fabric, and herein is used to refer to the open space between yarns. Examples of the mesh include tulle, cabochon elastic mesh, high-strength mesh, stiff mesh lining, mesh interlocking fabric, nylon mesh, and polyester mesh. The mesh facilitates air transfer through the fabric, reduces air resistance, and thus allows for easier assembly onto an RPT device.
[0299] In one form of the present invention, the mesh is characterized by an aperture of about 0.001 mm to about 5 mm. In other forms of the present invention, the aperture is about 0.002 mm to about 5 mm, about 0.003 mm to about 5 mm, about 0.004 mm to about 5 mm, about 0.005 mm to about 5 mm, about 0.006 mm to about 5 mm, about 0.007 mm to about 5 mm, about 0.008 mm to about 5 mm, about 0.009 mm to about 5 mm, about 0.01 mm to about 5 mm, about 0.01 mm to about 4 mm, about 0.01 mm to about 3 mm, about 0.01 mm to about 2 mm, or about 0.01 mm to about 1 mm.
[0300] In one form of this technology, the mesh is characterized in that the mesh shape is selected from hexagonal, rhomboid, circular, or a combination thereof.
[0301] In one form of the present invention, the net is characterized in that the yarn denier is from about 5 to about 100. In other forms of the present invention, the yarn denier is from about 10 to about 100, from about 10 to about 90, from about 10 to about 100, from about 10 to about 80, from about 10 to about 70, from about 10 to about 60, or from about 10 to about 50.
[0302] In one form of this technology, the web is characterized by a fabric weight GSM (grams per square meter) of approximately 10 gsm (g / m²). 2 From about 12 gsm to about 100 gsm. In other forms of this technology, the weight is about 12 gsm to about 100 gsm, about 14 gsm to about 100 gsm, about 16 gsm to about 100 gsm, about 18 gsm to about 100 gsm, about 20 gsm to about 100 gsm, about 20 gsm to about 90 gsm, about 20 gsm to about 80 gsm, about 20 gsm to about 70 gsm, about 20 gsm to about 60 gsm, or about 20 gsm to about 50 gsm.
[0303] In one form of this technology, the mesh is characterized by a porosity of at least about 50%. In other forms of this technology, the porosity is at least about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, or about 95%.
[0304] In one form of the present invention, the net is characterized in that its length is about 1% to about 20% of the length of the body. In other forms of the present invention, the relative length is about 1% to about 19%, about 1% to about 18%, about 1% to about 17%, about 1% to about 16%, about 1% to about 15%, about 1% to about 14%, about 1% to about 13%, about 1% to about 12%, about 1% to about 11%, or about 1% to about 10%.
[0305] Figure 6AA schematic diagram of a textile cover 6000 (e.g., a knitted textile cover) is shown. The textile cover 6000 may have an open tubular configuration with a hollow interior. The textile cover 6000 includes a body 6002. The body 6002 includes a first open end 6004 and a second open end 6006. The first open end 6004 may include a bonding edge 6008 (e.g., a strip of textile material may be folded along the first open end onto the exposed edge of the textile cover to form a bonding edge). The width of the bonding edge 6008 may be from about 2 mm to about 10 mm, or preferably about 5 mm. The bonding edge 6008 is configured to mate with a recess 6020 on a CPAP generator device. The second open end 6006 may include a ribbed edge 6010. The ribbed edge 6010 may be, for example, a ribbed knitted structure with elastic threads (e.g., a 2×2 ribbed knitted structure).
[0306] In one form of this technology, the ribbed edge 6010 is characterized by a width of about 3 mm to about 15 mm, or preferably about 10 mm.
[0307] When the RPT device is inserted into the hollow interior of the textile cover, the textile cover is configured to receive the RPT device through the second opening end 6006. Compared to the first opening end 6004, the second opening end 6006 of the body 6002 may have increased stretchability to facilitate stretching around the RPT device 4000 when the RPT device is inserted into the textile cover. This increased stretchability of the second opening end 6006 may be due to differences in the textile structure at the first opening end 6004 and the second opening end 6006. For example, a ribbed structure at the second opening end 6006 may provide increased stretchability compared to the textile structure at the first opening end 6004.
[0308] Figure 6AA textile cover 6000 is shown, sized to fit a CPAP generator device (e.g., RPT device 4000). For example, the dimensions of the inner surface of the textile cover may be configured to correspond to the dimensions of the outer surface of the RPT device, such that the shape and curvature of the textile cover matches the shape and curvature of the outer surface of the RPT device. The textile cover 6000 can be sized to fit any size RPT device 4000. The textile cover can also be sized to fit other forms of RPT devices. For example, the textile cover can be sized to conform to any protrusions and / or indentations on the RPT device. For example, the textile cover may include a window to expose a display 4294 on the RPT device. In another example, the body 6002 may be sized such that the diameter of one open end is smaller or larger than that of the other open end. For example, the first open end 6004 may have a larger diameter than the second open end 6006. The difference in diameter may be from about 1 mm to about 10 mm, or preferably about 2 mm.
[0309] Figure 6B An example of an RPT device 4000 is shown. Figure 6C An example of a textile cover 6000 before being assembled onto the RPT device 4000 is shown. The textile cover 6000 can be seamless, 3D, or cut-and-sewn. Figure 6D An example of a textile cover 6000 fitted onto the RPT device 4000 is shown. Once fitted, the textile cover 6000 can be removable. This allows the textile cover 6000 to be washed. Alternatively, the textile cover 6000 can be permanently attached to the RPT device 4000.
[0310] Figure 6E An example RPT device 4000 and its dimensions are shown. The diameter of the RPT device 4000 can be from about 60 mm to about 80 mm. The length or height of the CPAP device 4000 can be from about 150 mm to about 180 mm. In other examples, the RPT device 4000 may have other dimensions.
[0311] Figure 6FA schematic diagram of a textile cover 6000 is shown. The textile cover 6000 includes a body 6002. The body 6002 includes a first open end 6004 and a second open end 6006. The first open end 6004 includes a bonding edge 6008. The width of the bonding edge 6008 can be from about 2 mm to about 10 mm, or preferably about 5 mm. The bonding edge 6008 is configured to mate with a recess 6020 on an RPT device. The second open end 6006 may include a ribbed edge 6010. The ribbed edge 6010 can be a ribbed knitted structure (e.g., a 2×2 ribbed knitted structure, for example, with elastic yarn). In the example, a mesh 6012 may be provided adjacent to the bonding edge 6008. As shown, the length of the mesh relative to the body 6002 is from about 2% to about 5%. A window or through-hole 6014 is also present in the body 6002. The through-hole 6014 exposes a portion of the outer surface of the RPT device 4000. Through-hole 6014 exposes the function buttons and indicators on the housing of RPT device 4000.
[0312] In one form of this technology, the textile covering comprises a combination of fabrics. In this respect, the body can be formed by a combination of fabrics. For example, knitted fabrics can be used in combination with non-knitted fabrics. For example, a first knitted fabric can be used in combination with a second knitted fabric or a second non-knitted fabric.
[0313] Fabrics can be combined using techniques such as lamination, adhesives, heat sealing, mechanical bonding, chemical bonding, and / or welding. For example, when using adhesives, the adhesive can provide additional sound damping effects. Adhesives can also be provided on the inner surface of the textile covering for adhesion to the outer housing of the RPT device.
[0314] In one form of this technology, the body comprises at least two layers of fabric. The fabric layers can be joined together using lamination, adhesives, heat sealing, mechanical bonding, chemical bonding, and / or welding. For example, a first knitted fabric can also be layered with a second knitted fabric. These layers can be joined only at the seams.
[0315] In one form of this technology, the body comprises at least two fabrics joined together. These fabrics can be continuously connected to each other. At this point, one fabric transitions seamlessly to the other. Alternatively, the fabrics can be joined together via seams, stitches, and / or adhesives. This allows for the use of different types of fabrics to form the body to achieve multiple functions. For example, a mesh can be attached to the body via seams, stitches, and / or adhesives.
[0316] When at least two fabrics are used to form the main body, the first fabric can be an outer fabric or an outer layer fabric, and the second fabric can be an inner fabric or an inner layer fabric. The outer fabric faces outward, while the inner fabric contacts the outer surface of the RPT device housing during use. The at least two fabrics can be different fabrics with different properties. For example, the outer fabric may have a high thread count to give the user a silky smooth texture. The inner fabric may have appropriate thickness, pore size, denier, etc., to provide sound insulation.
[0317] In one form of this technology, the inner fabric or inner layer fabric is a knitted fabric comprising coated yarns. These yarns may be coated with an anti-slip material. In another form of this technology, the inner fabric or inner layer fabric is a woven fabric, a non-woven fabric, or a spacer fabric comprising a coating of anti-slip material formed on a surface configured to contact the RPT device. The anti-slip material may be silicone, thermoplastic polyurethane (TPU), polyvinyl chloride (PVC), or a combination thereof. In the example, the outer fabric may be a knitted fabric or a woven fabric.
[0318] Figure 6G A schematic diagram of an example textile cover 6000 is shown. The textile cover 6000 includes a body 6002. The body 6002 includes a first open end 6004 and a second open end 6006. The first open end 6004 may include a bonding edge 6008. The width of the bonding edge 6008 may be from about 2 mm to about 10 mm, or preferably about 5 mm. The bonding edge 6008 is configured to mate with a recess 6020 on an RPT device. The second open end 6006 may include a ribbed edge 6010. The ribbed edge 6010 may be a ribbed knitted structure (e.g., a 2×2 ribbed knitted structure, for example, with elastic yarn). The body 6002 includes a first outer fabric 6016 and a second inner fabric 6018. The inner fabric 6018 may in particular be a knitted fabric. The knitted fabric may include yarn coated with an anti-slip material (such as silicone).
[0319] In one embodiment of this technology, the body further includes a reinforcement zone. This reinforcement zone is located near and / or adjacent to the sound-generating area of the RPT device, thereby providing further sound damping.
[0320] The reinforcing area may include at least one additional fabric layer. This fabric layer may be combined with the underlying fabric of the body using lamination, adhesives, heat sealing, mechanical bonding, chemical bonding, welding, or a combination thereof.
[0321] In one form of this technology, the fabric in the reinforcing layer is layered, such that the holes in each fabric layer are offset relative to each other. This can further help dissipate sound.
[0322] In one form of this technology, the reinforcing region is characterized by a thickness of about 3 µm to about 10 mm. In other forms of this technology, the thickness is about 2 μm to about 10 mm, about 3 μm to about 10 mm, about 4 μm to about 10 mm, about 5 μm to about 10 mm, about 6 μm to about 10 mm, about 7 μm to about 10 mm, about 8 μm to about 10 mm, about 9 μm to about 10 mm, about 10 μm to about 10 mm, about 20 μm to about 10 mm, about 40 μm to about 10 mm, about 50 μm to about 10 mm, about 60 μm to about 10 mm, about 80 μm to about 10 mm, about 100 μm to about 10 mm, about 100 μm to about 9 mm, about 100 μm to about 8 mm, about 100 μm to about 7 mm, about 100 μm to about 6 mm, about 100 μm to about 5 mm, about 100 μm to about 4 mm, about 100 μm to about 3 mm, about 100 μm to about 2 mm, or about 100 μm to about 1 mm.
[0323] As described above, the internal structure of the CPAP generator unit includes sound-absorbing foam and chambers to eliminate noise radiated from the unit's air inlet. The generated noise can be further reduced by targeting the radiated noise generated by the CPAP generator unit housing (housing radiated noise).
[0324] 5.6 Air Circuit According to one aspect of the technology, the air circuit 4170 is a conduit or tube that is constructed and arranged to allow airflow to travel between two components (such as the RPT device 4000 and the patient interface 3000 or 3800) during use.
[0325] Specifically, the air circuit 4170 can be fluidly connected to the outlet and patient interface of the pneumatic block 4020. 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.
[0326] In some forms, the air circuit 4170 may include one or more heating elements configured to heat air in the air circuit, for example, to maintain or raise the temperature of the air. The heating element may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around an axis of the air circuit 4170. The heating element may be connected to a controller, such as a central controller 4230. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.
[0327] 5.7 Humidifier 5.7.1 Humidifier Overview In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 5A As shown), to change the absolute humidity of the air or gas intended for delivery to the patient relative to 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 ambient air) before it is delivered to the patient's airway.
[0328] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving airflow, and a humidifier for delivering humidified air. Air The humidifier outlet is 5004. In some forms, such as... Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which is adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.
[0329] 5.7.2 Humidifier Components 5.7.2.1 Water Storage Tank According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to hold or retain a volume of liquid to be evaporated (e.g., water) to humidify the airflow. The water reservoir 5110 may be configured to hold a predetermined maximum volume of water to provide adequate humidification at least for the duration of a respiratory therapy session, such as an overnight sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 ml, 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply system.
[0330] According to one aspect, the water reservoir 5110 is configured to increase the humidity of the airflow from the RPT device 4000 as air flows through it. In one form, the water reservoir 5110 may be configured to facilitate the airflow traveling in a curved path through the reservoir 5110 while in contact with the water therein.
[0331] According to one form, the storage 5110 can, for example, be along such a path. Figure 5A and Figure 5B The lateral direction shown is removed from the humidifier 5000.
[0332] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any orifice and / or between its sub-assemblies, when the reservoir 5110 is displaced and / or rotated from its normal operating direction. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent loss of pneumatic pressure due to leakage and / or flow resistance.
[0333] 5.7.2.2 Conductive Component According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume within the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes are equally applicable. All or part of the conductive portion 5120 may be made of a thermally conductive material such as aluminum (e.g., with a thickness of approximately 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastic. In some cases, suitable thermal conductivity may be achieved using materials with appropriate geometries and lower thermal conductivity.
[0334] 5.7.2.3 Humidifier storage base In one form, the humidifier 5000 may include a humidifier reservoir base 5130 (e.g., Figure 5B As shown, the humidifier reservoir base is configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include locking features, such as a locking lever 5135 configured to retain the reservoir 5110 in the humidifier reservoir base 5130.
[0335] 5.7.2.4 Water level indicator The humidifier storage unit 5110 may include, for example: Figures 5A to 5B The water level indicator 5150 is shown. In some forms, the water level indicator 5150 can provide a user (such as a patient 1000 or a caregiver) with one or more indications of the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.
[0336] 5.7.2.5 Humidifier Transducer The humidifier 5000 may include one or more humidifier transducers (sensors) 5210, replacing or excluding the transducer 4270 described above. The humidifier transducer 5210 may include, for example... Figure 5COne or more of the following are shown: air pressure sensor 5212, air flow sensor 5214, temperature sensor 5216, or humidity sensor 5218. The humidifier transducer 5210 may generate one or more output signals that can be transmitted to a controller (such as a central controller 4230 and / or a humidifier controller 5250). In some forms, the humidifier transducer may be externally located to the humidifier 5000 (such as in the air circuit 4170) when communicating output signals to the controller.
[0337] 5.7.2.5.1 Pressure transducer As an addition to or replacement of the pressure sensor 4272 provided in the RPT device 4000, one or more pressure transducers 5212 may be provided to the humidifier 5000.
[0338] 5.7.2.5.2 Flow Transducer As an addition to or replacement of the flow sensor 4274 provided in the RPT device 4000, one or more flow transducers 5214 may be provided to the humidifier 5000.
[0339] 5.7.2.5.3 Temperature transducer The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures, such as the temperature of the heating element 5240 and / or the temperature of the airflow downstream of the humidifier outlet 5004. In some forms, the humidifier 5000 may also include a temperature sensor 5216 to detect the temperature of ambient air.
[0340] 5.7.2.5.4 Humidity transducer In some forms, the humidifier 5000 may include one or more humidity sensors 5218 to detect the humidity of a gas, such as ambient air. In some forms, the humidity sensor 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.
[0341] 5.7.2.6 Heating element In some cases, a heating element 5240 may be provided to the humidifier 5000 to provide heat input to one or more volumes of water in the humidifier reservoir 5110 and / or to an airflow. The heating element 5240 may include heating components, such as resistance-heated rails. A suitable example of the heating element 5240 is a layered heating element, such as that described in PCT Patent Application Publication No. WO2012 / 171072, which is incorporated herein by reference in its entirety.
[0342] In some configurations, the heating element 5240 may be disposed within the humidifier base 5006, wherein heat can be supplied primarily to the humidifier reservoir 5110 via conduction, such as... Figure 5B As shown.
[0343] 5.7.2.7 Humidifier Controller According to one arrangement of the present technology, the humidifier 5000 may include, for example: Figure 5C The humidifier controller 5250 is shown. In one form, the humidifier controller 5250 may be part of a central controller 4230. In another form, the humidifier controller 5250 may be a separate controller that can communicate with the central controller 4230.
[0344] In one embodiment, the humidifier controller 5250 may receive measurements of characteristics (such as temperature, humidity, pressure, and / or flow rate) of, for example, airflow, reservoir 5110, and / or water in the humidifier 5000 as inputs. The humidifier controller 5250 may also be configured to execute or implement humidifier algorithms and / or deliver one or more output signals.
[0345] like Figure 5C As shown, the humidifier controller 5250 may include one or more controllers, such as a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240.
[0346] 5.8 Breathing Therapy Mode Various breathing therapy modalities can be implemented through the publicly available breathing therapy system.
[0347] 5.8.1 High-flow therapy In other forms of respiratory therapy, the pressure of the airflow is not controlled as in respiratory pressure therapy. Instead, the central controller 4230 controls the pressure generator 4140 to deliver an airflow of a device flow rate. Qd Controlled as treatment flow or target flow QtgtThe therapeutic flow rate, or target flow rate Qtgt, is typically positive throughout the patient's respiratory cycle. Such forms are usually grouped under the heading of flow therapy. In flow therapy, the therapeutic flow rate... Qtgt This can be a constant value hard-coded or manually entered into the RPT device 4000. If the treatment flow rate... Qtgt When the flow rate is sufficient to exceed the patient's peak inspiratory flow rate, the therapy is typically referred to as high-flow therapy (HFT). Alternatively, the therapeutic flow rate can be a curve showing the change in flow rate over the respiratory cycle. Qtgt ( t ).
[0348] 5.9 Glossary To achieve the purposes of this technical 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.
[0349] 5.9.1 General 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 some other combination of breathable gases, such as oxygen-enriched air.
[0350] environment In some forms of this technology, the term "environment" will be considered to mean (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.
[0351] For example, the environment relative to a humidifier humidity This could be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's bedroom. This type of ambient humidity can differ from the humidity outside the patient's bedroom.
[0352] In another example, environmental stress can be stress that is either close to the body or outside the body.
[0353] 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, for example, by the RPT device or emitted from the mask or patient interface. Ambient noise may be generated by sources outside the room.
[0354] Automated Positive Airway Pressure (APAP) Therapy : CPAP therapy in which the treatment pressure can be automatically adjusted between a minimum and a maximum (e.g., varying with each breath), depending on the presence of an indication of an SDB event.
[0355] Continuous positive airway pressure (CPAP) therapyRespiratory pressure therapy, in which the therapeutic pressure remains 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 some forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing when no indication of partial upper airway obstruction is detected.
[0356] flow Flow rate refers to the volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, referring to flow rate will refer to a scalar, i.e., a quantity that only has magnitude. In other cases, referring to flow rate will refer to a vector, i.e., a quantity that has both magnitude and direction. Flow rate can be represented by symbols. Q The term "flow" is sometimes simply abbreviated as "flow" or "airflow".
[0357] In the example of patient breathing, the flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle, and therefore negative for the expiratory portion. Device flow rate Qd This is the flow rate of air leaving the RPT unit. Total flow rate. Qt It is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. Ventilation flow rate Qv This is the flow rate of air leaving the vent to allow for flushing of exhaled air. Leakage flow rate. Ql This refers to flow leakage from the patient interface system or elsewhere. Respiratory flow. Qr It is the flow rate of air received from the patient's respiratory system.
[0358] Flow therapy This includes respiratory therapy that delivers a flow of air to the airway inlet at a controlled flow rate known as therapeutic flow, which is typically positive throughout the patient’s respiratory cycle.
[0359] humidifier The term "humidifier" will be considered to refer to a humidifying device that is constructed and arranged or configured with a physical structure to provide a therapeutically beneficial amount of water (H2O) vapor to an airflow to alleviate a patient's medical respiratory symptoms.
[0360] leakage The term "leak" will be used to describe an unintended flow of air. In one example, a leak might occur due to an incomplete seal between the mask and the patient's face. In another example, a leak might occur in a bend in the swivel tube leading to the environment.
[0361] 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 the end of the air circuit.
[0362] Radiated noise (acoustic) Radiated noise in this document refers to noise transmitted to the patient by 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.
[0363] Vent noise (acoustic) Ventilation noise in this document refers to the noise generated by the airflow through any ventilation opening (such as the ventilation hole of a patient interface).
[0364] Oxygen-rich air Oxygen-rich air is air with an oxygen concentration greater than that of atmospheric air (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 shortened to "oxygen".
[0365] Medical oxygen Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.
[0366] patient People, regardless of whether they have respiratory illnesses.
[0367] pressure: Force per unit area. Pressure can be expressed in units, including cmH2O, gf / cm². 2 And 1000 pascals. 1 cmH2O equals 1 g-f / cm 2 And it is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m). 2 =1 millibar to 0.001 atmospheres. In this specification, unless otherwise stated, pressure is given in cmH2O.
[0368] 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.
[0369] Respiratory pressure therapy Air supply is applied to the airway inlet under a therapeutic pressure that is normally positive relative to the atmosphere.
[0370] VentilatorMechanical devices that provide pressure support to patients to perform some or all of their breathing tasks.
[0371] 5.9.1.1 Materials and their properties hardness Indentation hardness refers to the hardness measured by an indenter (e.g., according to ASTM D2240) of a material property.
[0372] "Soft" materials may include silicone resins or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.
[0373] "Hard" materials can include polycarbonate and polypropylene, and are not easily deformed, for example, under finger pressure.
[0374] Silicone resin or silicone elastomer A synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or compression-molded silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.
[0375] polycarbonate Bisphenol A carbonate is a thermoplastic polymer.
[0376] 5.9.1.2 Mechanics axis: a. neutral axis A beam or slab with no longitudinal stress or strain in its cross-section.
[0377] b. Vertical axis An axis that extends along the length of a shape. This axis typically passes through the center of the shape.
[0378] c. Circumferential axis Axis: Axis that is oriented perpendicularly to the longitudinal axis. This axis can specifically exist in pipes, tubes, cylinders, or similar shapes with circular and / or elliptical cross-sections.
[0379] Deformation The process by which the original geometry of a component changes when subjected to a force (e.g., a force in the direction relative to an axis). This method may include stretching or compression, bending, and twisting.
[0380] elasticityThe ability of a material to recover its original geometry after deformation.
[0381] soft Structure or component: A structure or component that will change shape (e.g., bend) when it is made to support its own weight for a relatively short period of time, such as 1 second.
[0382] Resilience The ability of a material to absorb energy during elastic deformation and release energy during unloading.
[0383] elasticity During unloading, virtually all of the energy is released. This includes, for example, certain silicones and thermoplastic elastomers.
[0384] rigidity Structure or component: A structure or component that will not substantially change shape when subjected to the loads typically encountered in use. An example of such use could be, for instance, setting and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway under a pressure of approximately 20 to 30 cmH2O.
[0385] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component may be flexible in the first direction and rigid in the second direction.
[0386] Stiffness of structure or component (or rigidity Stiffness is the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. The structure or component can provide different resistance in different directions. The opposite of stiffness is flexibility.
[0387] viscosity The ability of a material to resist flow.
[0388] viscoelasticity The ability of a material to exhibit elastic and viscous behavior during deformation.
[0389] yield This refers to the situation where a material does not return to its original geometry after deformation.
[0390] 5.9.1.3 Structural Components Compression component: A structural element that resists compressive forces.
[0391] bendA bend is an example of a structure that guides the axis of an airflow traveling through it to change direction by an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. A bend can have an approximately circular cross-section. In another form, a bend can have an elliptical or rectangular cross-section. In some forms, the bend can rotate relative to the mating component, for example, approximately 360 degrees. In some forms, the bend can be removable from the mating component, for example, via a snap-fit connection. In some forms, the bend can be assembled onto the mating component during manufacturing via a disposable snap-fit, but cannot be removed by the patient.
[0392] frame The term "frame" is considered to refer to the mask structure that bears tensile loads between two or more connection points with the hood. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.
[0393] membrane The term "membrane" is to be understood as referring to a typically thin element that is preferably substantially non-flexural but tensile.
[0394] Lace (noun) It is designed to resist tension.
[0395] Thin structure: a. beam, i. Compared to the other two dimensions, the beam can be relatively long in one dimension, making the smaller dimension relatively thinner compared to the longer dimension.
[0396] b. membrane, i. Relatively long in two dimensions and relatively thin in one dimension. Easily deforms in response to bending forces. Resistant to tension (and possibly compression).
[0397] c. Plates and casing i. They can be relatively long in two directions and relatively thin in one dimension. They can have bending, tensile, and / or compressive stiffness.
[0398] Thick structure: solid seal : can be the noun form referring to a structure ("sealing") or the verb form referring to an effect ("sealing"). Two elements can be constructed and / or arranged to "seal" or to achieve "sealing" between them, without requiring a separate "sealing" element itself.
[0399] shellThe term "shell" is generally considered to refer to a curved, relatively thin structure with bending, tensile, and compressive stiffness. For example, the curved structural walls of a face mask can be an outer shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.
[0400] reinforcement A reinforcement is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.
[0401] pillar A strut will be considered a structural component designed to increase the compressive strength of another component in at least one direction.
[0402] Rotation axis (noun) A sub-assembly of a component configured to rotate, preferably independently, about a common axis under low torque. In one form, the shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the shaft may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assembly of the component preferably comprises a pair of mating cylindrical ducts. In use, there may be little or no airflow leaking from the shaft.
[0403] 5.9.2 Respiratory and Circulatory Systems Sleep apnea According to some definitions, apnea is considered to have occurred when the flow rate drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to have occurred when some obstruction in the airway prevents airflow even with patient effort. Central apnea is considered to have occurred when apnea is detected despite the airway being patent, due to reduced or absent respiratory effort. Mixed apnea is considered to have occurred when reduced or absent respiratory effort occurs simultaneously with airway obstruction.
[0404] respiratory rate The frequency of a patient's spontaneous breathing, which is usually measured in breaths per minute.
[0405] Duty cycle : The ratio of inspiratory time Ti to total respiratory time Ttot.
[0406] Trying to breathe: Spontaneous breathing involves the act of trying to breathe.
[0407] respiratory cycle The expiratory phase: the time period from the start of expiratory flow to the start of inspiratory flow.
[0408] Traffic limitsFlow restriction is considered a state of respiratory function in which increased effort by the patient does not result in a corresponding increase in flow. Flow restriction occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow restriction. Flow restriction occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow restriction.
[0409] Types of flow-limited inhalation waveforms: (i) Flat-top shape: It rises first, followed by a relatively flat section, and then falls.
[0410] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.
[0411] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.
[0412] (iv) Inverted chair shape: has a relatively flat section followed by a single local peak at the trailing edge.
[0413] Insufficient breathing Under certain conditions, inadequate breathing is considered a reduction in flow, not an interruption of flow. In one form, inadequate breathing is considered to have occurred when the flow rate drops below a threshold rate for a sustained period. Central inadequate breathing is considered to have occurred when inadequate breathing is detected due to reduced respiratory effort. In one form for adults, any of the following can be considered inadequate breathing: (i) The patient's breathing decreases by 30% for at least 10 seconds, plus an associated 4% desaturation; or (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% associated desaturation or arousal.
[0414] hyperventilation Traffic volume has increased to above normal levels.
[0415] respiratory cycle The inspiratory phase: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory phase of the respiratory cycle.
[0416] Openness (Airway): The degree to which the airway is open or the degree to which the airway is open. An open airway is an open airway. Airway patency can be quantified, for example, a value of one (1) indicates patency, and a value of zero (0) indicates closure (obstruction).
[0417] Positive end-expiratory pressure (PEEP) The pressure above atmospheric pressure that exists in the lungs at the end of exhalation.
[0418] Peak traffic ( Qpeak ): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.
[0419] Respiratory flow rate, patient airflow rate, respiratory airflow rate ( Qr These terms can be understood as estimates of the respiratory flow rate of the RPT device, as opposed to “true respiratory flow rate,” which is the actual respiratory flow rate experienced by the patient, usually expressed in liters per minute.
[0420] Tidal volume ( Vt Inspiratory volume: The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, inspiratory volume... Vi The volume of inhaled air is equal to the volume of exhaled air. Ve (The volume of exhaled air), and therefore the individual tidal volume Vt It can be defined as equal to any quantity. In fact, tidal volume... Vt Estimated as inspiratory volume Vi and expiratory volume Ve A certain combination, such as the average.
[0421] Inhalation time ( Ti ): The duration of the inspiratory portion of the respiratory flow waveform.
[0422] Exhalation time ( Te ): The duration of the expiratory portion of the respiratory flow waveform.
[0423] (Total) Time ( Ttot ): The total duration between the start of the inspiratory portion of a respiratory flow waveform and the start of the inspiratory portion of a subsequent respiratory flow waveform.
[0424] Typical short-term ventilation: Vent values are recent values of ventilation that tend to cluster around their respective values within a predetermined time range; that is, a measure of the central tendency of recent ventilation values.
[0425] Upper airway obstruction (UAO) This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or may even decrease as the pressure differential in the upper airway increases (Starling resistance behavior).
[0426] ventilation ( Vent Minute ventilation is a measurement of the total amount of gas exchanged by a patient's respiratory system. Measurements may include one or both of inspiratory and expiratory flow rates (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.
[0427] 5.9.3 Ventilation Adaptive Servo Ventilator (ASV): A servo ventilator with a variable rather than a fixed target ventilation. The variable target ventilation can be determined based on a certain characteristic of the patient (e.g., the patient's breathing characteristics).
[0428] Standby rate: A parameter of the ventilator that sets the minimum respiratory rate (usually measured in breaths per minute) that the ventilator will deliver to the patient if not triggered by spontaneous breathing effort.
[0429] Cyclic: Termination of the inspiratory phase of a ventilator cycle. When a ventilator delivers breaths to a spontaneously breathing patient, the ventilator cycle is considered to end at the end of the inspiratory portion of the respiratory cycle.
[0430] Positive expiratory airway pressure (EPAP): The base pressure to which the pressure changes within the respiratory tract to produce the desired interface pressure that the ventilator will attempt to achieve at a given time.
[0431] End-expiratory pressure (EEP): The desired interface pressure that the ventilator will attempt to achieve at the end of the expiratory phase. (If the pressure waveform template...) ( The value is zero at the end of exhalation, that is, when... =1 ( If ) = 0, then EEP equals EPAP.
[0432] Inspiratory Positive Airway Pressure (IPAP): The maximum desired interface pressure that the ventilator will attempt to achieve during the inspiratory phase of breathing.
[0433] Pressure support: This refers to the pressure increase during inspiratory breathing that exceeds the pressure during expiratory breathing, and typically means the pressure difference between the maximum inspiratory pressure and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference the ventilator is designed to achieve, rather than the difference it actually achieves.
[0434] Servo ventilator: A ventilator that measures a patient’s ventilation volume, has a target ventilation volume, and adjusts the level of pressure support to enable the patient to achieve the target ventilation volume.
[0435] Spontaneous / Timed (S / T): A mode of operation for a ventilator or other device that attempts to detect the onset of spontaneous breathing in a patient. However, if the device fails to detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.
[0436] Oscillation: A term equivalent to pressure support.
[0437] Triggering: A patient is considered to be triggered when a ventilator or other respiratory therapy device (such as an RPT device or portable oxygen concentrator) delivers a volume of breathable gas to a spontaneously breathing patient. Triggering typically occurs at or near the start of a respiratory portion of the patient's effortful respiratory cycle.
[0438] 5.9.4 Anatomy 5.9.4.1 Facial Anatomy Ala: The outer wall or "wing" of each nostril (plural: alar) Nasal wing angle: The angle formed between the nasal wings of each nostril.
[0439] Alar tip: the outermost point on the ala of the nose.
[0440] Alar curvature (or alar ridge) point: the last point in the curvature baseline of each alar, found in the crease formed by the connection between the alar and the cheek.
[0441] Auricle: The entire visible external part of the ear.
[0442] (Nose) Skeletal framework: The skeletal framework of the nose includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.
[0443] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.
[0444] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.
[0445] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt horizontal plane that intersects the subnasal point.
[0446] Frankfurt Plane: A line extending from the lowest point of the eye socket margin to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.
[0447] The glabella is located on the soft tissue at the most prominent point in the sagittal plane at the center of the forehead.
[0448] External nasal cartilage: a cartilaginous plate that is basically triangular in shape. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.
[0449] Lower lip (midpoint of the lower lip): The lip that extends between the point below the nose and the mouth.
[0450] Upper lip (midpoint of the upper lip): The lip that extends between the mouth and the supramental point.
[0451] Greater alar cartilage: A cartilaginous plate located beneath the lateral nasal cartilage. It curves around the front of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane comprising three or four smaller cartilages, including the alar.
[0452] Nostrils: Roughly oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils (nares) is nasal nasal (naris) (nostril). Nostrils are separated by the nasal septum.
[0453] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.
[0454] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).
[0455] The lowest point on the face where the auricle attaches to the skin.
[0456] The highest point on the face where the auricle attaches to the skin.
[0457] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.
[0458] The philtrum is a midline groove that extends from the lower border of the nasal septum to the top of the upper lip.
[0459] Prechin point: Located on the soft tissue, at the very front midpoint of the chin.
[0460] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.
[0461] Sagittal plane: A vertical plane running from front to back. The central sagittal plane is the sagittal plane that divides the body into the right and left halves.
[0462] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.
[0463] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.
[0464] Posterosuperior lateral lamina: the point at the lower edge of the base of the nasal ala, where the base of the nasal ala joins the skin of the upper (superior) lip.
[0465] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the central sagittal plane.
[0466] Supramental point: The point on the midline of the lower lip where the greatest concavity occurs between the midpoint of the lower lip and the premental point of the soft tissue. Skull Anatomy Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.
[0467] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.
[0468] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the orbit. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral border.
[0469] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary from individual to individual; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.
[0470] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the depression at the top of the bridge of the nose.
[0471] Occipital bone: The occipital bone is located on the back and lower part of the skull. It includes the foramen magnum, an oval-shaped opening through which the cranial cavity connects to the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.
[0472] The eye socket is the bony cavity in the skull that houses the eyeball.
[0473] Parietal bone: The parietal bone is the top and sides of the skull when joined together.
[0474] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.
[0475] Cheekbones: The face consists of two cheekbones, which are located on the upper side of the face and form the protrusions of the cheeks.
[0476] 5.9.4.2 Anatomy of the Respiratory System Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.
[0477] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.
[0478] Lungs: The human respiratory organ. The conduction area of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.
[0479] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located in the middle of the face above and behind the nose. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular "concha") or nasal turbinates. The front of the nasal cavity is the nose, while the back connects to the nasopharynx via the internal nasal openings.
[0480] Pharynx: The part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).
[0481] 5.9.5 Patient Interface Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.
[0482] Headgear: A headgear is a form of positioning and stabilizing structure designed to hold a device (such as a mask) on the head.
[0483] Inflation chamber: The mask inflation chamber is considered to refer to the portion of the patient interface having walls that at least partially enclose a volume of space, which, during use, contains air pressurized therein to above atmospheric pressure. An outer shell may form part of the wall of the mask inflation chamber.
[0484] Sealing: can be the noun form referring to a structure ("seal") or the verb form referring to an effect ("seal"). Two elements can be constructed and / or arranged to "seal" or to achieve a "seal" between them without requiring a separate "seal" element itself.
[0485] Ventilation port (noun): A structure that allows airflow from inside the mask or tubing to ambient air for clinically effective flushing of exhaled gases. For example, depending on the mask design and treatment pressure, clinically effective flushing can involve a flow rate from approximately 10 liters per minute to approximately 100 liters per minute.
[0486] 5.9.6 Shape of the structure Products according to this technology may include one or more three-dimensional mechanical structures, such as mask liners or impellers. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a face-contact (e.g., external) surface and separate non-face-contact (e.g., underside or inner) surfaces. In yet another example, a structure may include a first surface and a second surface.
[0487] To facilitate the description of the shape of three-dimensional structures and surfaces, we first consider points. p The cross-section passing through the surface of the structure. See also Figures 3B to 3F These diagrams illustrate points on the surface. p An example of a cross-section at a given location, and the resulting planar curve. Figures 3B to 3F It also provides examplesp The outward normal vector at that location. p The outward normal vector at a point points away from the surface. In some examples, we describe the surface from the viewpoint of an imaginary little person standing on it.
[0488] 5.9.6.1 One-dimensional curvature The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and a quantity (e.g., the reciprocal of the radius of the circle that only touches the curve at p).
[0489] Positive curvature: If the curve at point p turns outward toward the normal, then the curvature at that point will be positive (if the figures in the image were to leave point p, they would have to walk uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to relatively small positive curvature). Such curves are often referred to as concave surfaces.
[0490] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if you imagine a little person leaving point p, they can walk horizontally without going up or down). See also Figure 3D .
[0491] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if you imagine little figures leaving point p, they must be going downhill). See also Figure 3E (and Figure 3F Compared to relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to a relatively large negative curvature). Such curves are usually called convex.
[0492] 5.9.6.2 Two-dimensional surface curvature A description of the shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. These cross sections may cut through the surface in a plane including an outward normal (“normal plane”), and each cross section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has, for example, a relatively small amplitude. Figures 3B to 3F A planar curve in a diagram can be an example of multiple cross-sections at a specific point.
[0493] Principal curvature and principal direction: The direction of the normal plane to which the curvature of the curve reaches its maximum and minimum values is called the principal direction. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, the minimum curvature appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross-section along the principal direction. The principal curvature at point p is the curvature along the principal direction.
[0494] A region of a surface: a set of points connected on the surface. These points within a region may have similar characteristics, such as curvature or sign.
[0495] Saddle-shaped region: The region where the principal curvature has opposite signs at each point, that is, one is positive and the other is negative (depending on the direction the imagined person is turning, they may be going uphill or downhill).
[0496] Vault region: The region where the principal curvature has the same sign at each point, such as both being positive ("recessed vault") or both being negative ("convex vault").
[0497] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.
[0498] Planar region: A surface region in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).
[0499] Surface edge: The boundary or limit of a surface or region.
[0500] Path: In some forms of this technique, "path" will be considered to mean a path in a mathematical-topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, "path" can be described as a route or road, including, for example, a set of points on a surface. (An imagined path for a person is the place where they walk on the surface, and is similar to a garden path).
[0501] Path length: In some forms of this technique, “path length” will be considered to mean the distance along the surface from f(0) to f(1), i.e., the distance along a path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length of an imagined person would be the distance they must walk along the path on the surface).
[0502] Straight-line distance: Straight-line distance is the distance between two points on a surface, but it is independent of the surface itself. On a planar region, there will exist paths on the surface with the same path length as the straight-line distance between the two points. On a non-planar surface, there may not be paths with the same path length as the straight-line distance between the two points. (For the imaginary person, straight-line distance will correspond to the distance "in a straight line".) 5.9.6.3 Space Curves Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, that is, without endpoints. A space curve can be thought of as a one-dimensional segment of three-dimensional space. Imagine a person walking along a space curve on one strand of a DNA helix. The typical human left ear contains the helix, which is a left-handed helix; see [link to relevant documentation]. Figure 3Q The typical human right ear includes a spiral, which is a right-handed spiral; see [link / reference]. Figure 3R . Figure 3S A right-handed helix is shown. The edges of a structure, such as the edges of a membrane or impeller, can follow a space curve. Typically, a space curve can be described by the curvature and torsion at each point on the curve. Torque is a measure of how the curve deviates from the plane. Torque has a sign and magnitude. The torsion at a point on a space curve can be characterized by reference to the tangent vector, normal vector, and double normal vector at that point.
[0503] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies the direction and magnitude from that point. A tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If you imagine a person flying along a curve and falling from their aircraft at a specific point, the direction of the tangent vector is the direction they would have traveled.
[0504] Unit normal vector: When an imagined person moves along a curve, the tangent vector itself also changes. The unit vector pointing in the direction of the tangent vector's change is called the unit principal normal vector. It is perpendicular to the tangent vector.
[0505] A double-normal unit vector is a vector that is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see example...). Figure 3P ) or alternatively by the left-hand rule ( Figure 3O To determine.
[0506] Oscillating plane: A plane containing a unit tangent vector and a unit principal normal vector. See appendix. Figure 3O and 3P .
[0507] Torque of a space curve: Torque at a point on a space curve is the magnitude of the rate of change of the unit vector of the binormal at that point. It measures the degree to which the curve deviates from the osculating plane. A space curve lying in the osculating plane has zero torque. A space curve deviating relatively small from the osculating plane will have a relatively small amount of torque (e.g., a slightly inclined spiral path). A space curve deviating relatively large from the osculating plane will have a relatively large amount of torque (e.g., a sharply inclined spiral path). See also Figure 3S Since T2 > T1, the amount of twist near the top coil of the spiral in Figure 3 is greater than that of T1. Figure 3S The amount of twist of the bottom coil of the spiral.
[0508] Reference Figure 3P According to the right-hand rule, a space curve oriented towards the right-hand side of the double normal direction can be considered to have a right-hand positive twist (e.g., Figure 3S (The right-handed spiral shown). A space curve that turns away from the direction of the right-hand double normal can be considered to have a right-handed negative twist (e.g., a left-handed spiral).
[0509] Similarly, refer to the left-hand rule (see...) Figure 3O A space curve pointing towards the left-hand double normal direction can be considered to have a left-hand positive twist (e.g., a left-hand spiral). Therefore, left-hand positive is equivalent to right-hand negative. See also Figure 3T .
[0510] 5.9.6.4 holes Surfaces can have one-dimensional pores, such as pores defined by planar curves or spatial curves. Thin structures with pores (e.g., films) can be described as having one-dimensional pores. See, for example, [example missing]. Figure 3I The structure shown has a one-dimensional hole in the surface bounded by a planar curve.
[0511] The structure can have two-dimensional pores, such as pores defined by a surface. For example, an inflatable tire has two-dimensional pores defined by the inner surface of the tire. In another example, a bladder having cavities for air or gel can have two-dimensional pores. See, for example, [link to relevant documentation]. Figure 3L padding and through Figure 3M and Figure 3N An exemplary cross-section is shown, illustrating the inner surface defining a two-dimensional orifice. In yet another example, the conduit may include a one-dimensional orifice (e.g., at its inlet or outlet) and a two-dimensional orifice defined by the inner surface of the conduit. See also Figure 3K The two-dimensional hole in the structure shown is defined by the surface shown.
[0512] 5.10 Other Remarks 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 broadly encompassed within this technology. The upper and lower limits of these intermediate ranges (which may be independently included in the intermediate range) are also encompassed within this technology, but are subject to any explicit exclusions within the stated range. Where the stated range includes one or both of these limitations, the range excluding any one or both of those included limitations is also included within this technology.
[0513] Furthermore, where one or more values are stated herein as part of the implementation of the technology, it should be understood that, unless otherwise stated, such values may be approximate and may be used to any suitable significant number to the extent that the actual technical implementation allows or requires them.
[0514] Furthermore, as used herein, “approximately,” “basically,” “about,” or any similar terms mean + / - 5-10% of the stated value.
[0515] 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 pertains. While any methods and materials similar to or equivalent to those described herein may also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.
[0516] When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise specified, any and all components described herein should be understood as being capable of being manufactured, and therefore can be manufactured together or separately.
[0517] It must be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents, unless the context clearly indicates otherwise.
[0518] 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 any prior disclosure due to a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.
[0519] 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.
[0520] The subject 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. Subject headings should not be used to interpret the claims or limit their scope.
[0521] 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 required for practicing the technique. 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 shown 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.
[0522] Therefore, it should be understood that numerous modifications can be made to the exemplary examples, and that other arrangements can be designed without departing from the spirit and scope of this technology.
[0523] 5.11 List of reference numerals
Claims
1. A textile cover for absorbing sound generated by a respiratory pressure therapy (RPT) device, comprising: a body comprising a first open end and a second open end; wherein the first open end comprises a binding edge configured to mate with a recess at a first end of the RPT device; wherein the second open end comprises a ribbed edge for elastically engaging a second end of the RPT device; and wherein the textile cover is sized to frictionally engage an outer surface of the RPT device.
2. The textile cover of claim 1, wherein the textile cover is formed from a material selected from a woven fabric, a non-woven fabric, a knitted fabric, a spacer fabric, or a combination thereof.
3. The textile cover of claim 1, wherein the textile cover is formed from a warp knit fabric or a weft knit fabric.
4. The textile cover of claim 3, wherein the knit fabric comprises a yarn material selected from virgin and / or recycled polyester, polypropylene, polyamide, various spandex or stretch materials, poly(lactic acid), wool, cotton, bamboo, jute, or a combination thereof.
5. The textile cover of claim 2, wherein the body is formed from a combination of fabrics, wherein the combination of fabrics is joined using lamination, adhesive, heat sealing, mechanical bonding, chemical bonding, welding, or a combination thereof.
6. The textile cover of claim 5, wherein the combination of fabrics is at least two layers of fabric, the at least two layers of fabric comprising an outer fabric and an inner fabric.
7. The textile cover of claim 6, wherein the fabrics are layered such that the apertures in each fabric layer are offset relative to one another.
8. The textile cover of claim 1, wherein the binding edge is characterized by a width of about 2 mm to about 10 mm, or preferably about 5 mm.
9. The textile cover of claim 1, wherein the ribbed edge is characterized by a width of about 3 mm to about 15 mm, or preferably about 10 mm.
10. The textile cover of claim 1, wherein the body further comprises a reinforced zone proximate a sound generating region of the RPT device.
11. The textile cover of claim 10, wherein the reinforced zone comprises at least another layer of fabric.
12. The textile cover of claim 11, wherein the fabric in the reinforced zone is layered such that the apertures in each fabric layer are offset relative to one another.
13. The textile cover of claim 10, wherein the reinforced zone is characterized by a thickness of about 3 μm to about 10 mm.
14. The textile cover of claim 2, wherein when the fabric is a knit fabric, the knit fabric comprises a yarn coated with a slip resistant material; and wherein when the fabric is a woven fabric, a non-woven fabric, or a spacer fabric, a surface of the fabric configured to contact the RPT device comprises a coating formed from a slip resistant material.
15. The textile cover of claim 6, wherein when the inner fabric is a knit fabric, the knit fabric comprises yarns coated with a slip-resistant material; and wherein when the inner fabric is a woven fabric, a non-woven fabric, or a spacer fabric, a surface of the fabric configured to contact the RPT device comprises a coating formed of a slip-resistant material.
16. The textile cover of claim 14 or 15, wherein the slip-resistant material is selected from silicone, thermoplastic polyurethane (TPU), polyvinyl chloride (PVC), or a combination thereof.
17. The textile cover of claim 1, wherein the main body comprises a through-hole for exposing a portion of the outer surface of the RPT device.
18. The textile cover of claim 1, wherein the main body further comprises a mesh proximate to the joining edge.
19. The textile cover of claim 18, wherein the mesh is characterized by a pore size of about 0.01 mm to about 2 mm.
20. The textile cover of claim 18, wherein the mesh is characterized by a length relative to a length of the main body of about 1% to about 20%.
21. A therapy system for treating sleep disordered breathing, comprising: a respiratory pressure therapy (RPT) device to supply positive pressure breathable gas, the RPT device having a housing with an outer surface; and a textile cover according to any one of claims 1 to 20, wherein the textile cover has a hollow interior configured to receive the RPT device, the textile cover being configured to frictionally engage the outer surface of the RPT device.
22. An acoustic cover for a respiratory pressure therapy (RPT) device for treating sleep disordered breathing, comprising: a main body constructed from a textile material and having a tubular configuration with a hollow interior, the main body comprising at least one open end, wherein the hollow interior of the main body is configured to receive a housing of an RPT device such that the main body at least partially surrounds the housing in contact therewith, and wherein the textile material is configured to absorb sound radiating from the housing when the housing is received in the hollow interior and the RPT device is in use.
23. The acoustic cover of claim 22, wherein the at least one open end comprises a first open end and a second open end, the main body having a first textile structure along a first edge at the first open end and a second textile structure along a second edge at the second open end, the first textile structure being different from the second textile structure.
24. The acoustic cover of claim 23, wherein the second textile structure provides increased stretchability to the second edge of the main body compared to the first edge of the main body.
25. The acoustic cover of any one of claims 23 and 24, wherein the second textile structure is a ribbed textile structure, and the second edge is configured to elastically engage the RPT device.
26. A therapy system for treating sleep disordered breathing comprising: a respiratory pressure therapy (RPT) device to supply positively pressurised breathable gas, the RPT device having a housing with an outer surface; and an acoustically absorbent covering according to any one of claims 22 to 25, wherein the acoustically absorbent covering has a hollow interior configured to receive the RPT device, the acoustically absorbent covering being configured to frictionally engage the outer surface of the RPT device.
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